BS-800 Operation Manual PDF
BS-800 Operation Manual PDF
BS-800 Operation Manual PDF
Operator’s Manual
Basic Volume
© 2010 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2010-08.
, , , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and
other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.
i
Copyright
WARNING
It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or
personal injury.
NOTE
This equipment must be operated by skilled/trained clinical professionals.
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.
This warranty shall not extend to:
• Malfunction or damage caused by improper use or man-made failure.
• Malfunction or damage caused by unstable or out-of-range power input.
• Malfunction or damage caused by force majeure such as fire and earthquake.
• Malfunction or damage caused by improper operation or repair by unqualified or
• unauthorized service people.
• Malfunction of the instrument or part whose serial number is not legible enough.
• Others not caused by instrument or part itself.
ii
Copyright
Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:
• Return authorization: Contact the international Customer Service Department and obtain
a Return Materials Authorization number. This number must appear on the outside of the
shipping container. Returned shipments will not be accepted if the number is not clearly
visible. Please provide the model number, serial number, and a brief description of the
reason for return.
• Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges).
• Return address: Please send the part(s) or equipment to the address offered by the
international Customer Service Department
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
E-mail Address: service@mindray.com
Tel: +86 755 26582479 26582888
Fax: +86 755 26582934 26582500
iii
Preface
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. It is based on the maximum configuration and
therefore some contents may not apply to your product. It you have any questions, please
contact us.
Observance of this manual is a prerequisite for proper performance and correct operation, and
it ensures patient and operator safety. All graphics including screens and printouts in this
manual are for illustration purpose only and must not be used for any other purposes. The
screens and printouts on the product should prevail.
The product can be operated via both mouse and touchscreen. This manual describes
operating instructions based on the use of mouse.
The following three parts are included in this manual:
I. Basic Volume:
• Copyright
• Preface
• Safety Information
• Chapter 1 System Description
• Chapter 2 General Operating Procedure
• Chapter 3 System Setup
• Chapter 4 Operation Theories
II. Advanced Volume:
• Chapter 5 Reagents
• Chapter 6 Calibration
• Chapter 7 Quality Control
• Chapter 8 Sample Programming and Processing
• Chapter 9 Result Printouts
• Chapter 10 Chemistries
• Chapter 11 System Commands and Setup Options
• Chapter 12 Use of ISE Module
• Chapter 13 Use of Bar Code
• Chapter 14 LIS and RMS
iv
Preface
v
Preface
vi
Safety Information
Safety Symbols
Safety symbols are used in this manual in order to remind you of the instructions necessary to
operate the product safely and in accordance with its function and intended use. A safety
symbol and text constitutes a notice as shown in the table below:
Safety Information-1
Safety Information
Summary of Hazards
Introduction
Observe the following safety precautions when using the product. Ignoring any of these safety
precautions may lead to personal injury or equipment damage.
WARNING
If the product is used in a manner not specified by our company, the protection provided by
the product may be impaired.
WARNING
• When the MAIN POWER is turned on, users other than the servicing personnel authorized
by our company must not open the rear cover or side cover.
• Spillage of reagent or sample on the product may cause equipment failure and even
electric shock. Do not place sample and reagent on the product. In case of spillage, switch
off the power immediately, remove the spillage and contact our Customer Service
Department or your local distributor.
WARNING
• Do not touch such moving parts as sample probe, reagent probes, mixers and wash probe,
when the system is in operation.
• Do not put your finger or hand into any open part when the system is in operation.
Safety Information-2
Safety Information
WARNING
• Light sent by the photometer lamp may hurt your eyes. Do not stare into the lamp when
the system is in operation.
• If you want to replace the photometer lamp, first switch off the MAIN POWER and then
wait at least 15 minutes for the lamp to cool down before touching it. Do not touch the
lamp before it cools down, or you may get burned.
BIOHAZARD
• Inappropriately handling samples, controls and calibrators may lead to biohazardous
infection. Do not touch samples, mixtures or waste with your bare hands. Wear gloves and
lab coat and, if necessary, goggles.
• In case your skin contacts the sample, control or calibrator, follow the standard laboratory
safety procedure and consult a doctor.
WARNING
Reagents and concentrated wash solution are corrosive to human skins. Exercise caution when
using reagents and concentrated wash solution. In case your skin or clothes contact them,
wash them off with soap and clean water. If reagents or wash solution spills into your eyes,
rinse them with much water and consult an oculist.
Safety Information-3
Safety Information
Waste Hazards
Observe the following instructions to prevent environmental pollution and personal injury
caused by waste.
BIOHAZARD
• Some substances contained in reagent, control, concentrated wash solution and waste are
subject to regulations of contamination and disposal. Dispose of the waste in accordance
with your local or national rule for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
• Wear gloves and lab coat and, if necessary, goggles.
WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of the waste
analyzer in accordance with your local or national rule for waste disposal.
WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol.
Safety Information-4
Safety Information
Precautions on Use
Introduction
To use the product safely and efficiently, pay attention to the following operating precautions.
Intended Use
WARNING
The instrument is an automated chemistry analyzer for in vitro diagnostic use in clinical
laboratories and designed for in vitro quantitative determination of clinical chemistries in
serum, plasma, urine and cerebrospinal fluid samples. Please consult us before you use the
instrument for other purposes.
When drawing a clinical conclusion, please also refer to patients’ clinical symptoms and other
test results.
Environment Precautions
CAUTION
Evaluate the electromagnetic environment prior to operating the system.
Please install and operate the system in an environment specified by this manual. Installing
and operating the system in other environment may lead to unreliable results and even
equipment damage.
To relocate the system, please contact our Customer Service Department or your local
distributor.
Installation Precautions
WARNING
The product is a permanently installed equipment that is switched on and off via a switch or
breaker. Before installing the system, ensure that the building in which the system will be
located has been equipped with a switch or breaker that complies with GB 4793.1-2007 and is
marked for special use of the system.
Safety Information-5
Safety Information
CAUTION
Electromagnetic noise may interfere with operations of the system. Do not install devices
generating excessive electromagnetic noise around the system. Do not use such devices as
radio transmitters in the room housing the system. Do not use other CRT displays around the
system.
Do not use other medical instruments around the system that may generate electromagnetic
noise to interfere with their operations.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
mobile phones or radio transmitters), as these may interfere with the proper operation.
The electromagnetic environment should be evaluated prior to operation of the device.
This device has been designed and tested to CISPR 11 Class A, and in a domestic
environment may cause radio interference, in which case, you may need to take measures to
mitigate the interference.
NOTE
It is the manufacturer's responsibility to provide equipment electromagnetic compatibility
information to the customer or user.
It is the user's responsibility to ensure that a compatible electromagnetic environment for the
equipment can be maintained in order that it will perform as intended.
Safety Information-6
Safety Information
Operating Precautions
CAUTION
• Take the clinical symptoms or other test results of the patient into considerations when
making a diagnosis based on the measuring results produced by the system.
• Operate the system strictly as instructed by this manual. Inappropriate use of the system
may lead to unreliable test results or even equipment damage or personal injury.
• When using the system for the first time, first run calibrations, and then QC tests to make
sure the system is in proper state.
• Be sure to run QC tests every time when you use the system, otherwise the result may be
unreliable.
• Do not uncover the reagent carousel when the system is in operation. Keep the reagent
carousel cover closed.
• The RS-232 port on the analyzing unit is used for connection with the operation unit only.
Do not use it for other connections. Use the cables provided by our company or your local
distributor for the connection.
• The operation unit is a personal computer with the operating software installed. Installing
other software or hardware on the computer may interfere with the system operation. Do
not run other software when the system is working.
• Computer virus may destroy the operating software or test data. Do not use the computer
for other purposes or connect it to the Internet. If the computer is infected by virus, please
install anti-virus software to check for and clear virus.
• Do not touch the display, mouse or keyboard with wet hands or hands with chemicals.
• Do not place the MAIN POWER to ON again within 10 seconds since placing it to OFF;
otherwise the system may enter the protection status. If it does so, place the MAIN
POWER to OFF and place it to ON again.
Safety Information-7
Safety Information
CAUTION
• Maintain the system strictly as instructed by this manual. Inappropriate maintenance may
lead to unreliable results, equipment damage or personal injury.
• To wipe off dust from the system surface, use a soft, clean and wet (not too wet) cloth
soaked with soap water rather than organic solvents such as ethanol. After cleaning, wipe
the surface dry with dry cloth.
• Switch off all the powers and disconnect the power plug before cleaning. Take necessary
measures to prevent water ingression, otherwise equipment damage or personal injury may
be caused.
• Replacement of such major parts as photometer lamp, sample probe, reagent probes,
mixers and syringe plunger assembly must be followed by a calibration.
• Replacement of the photometer lamp should be done when the system power has been
switched off for at least 15 minutes.
• If the system is failed and needs servicing, contact our Customer Service Department or
your local distributor. The system may need to be stopped or transported during servicing,
which will probably cause biohazards, electric shock hazards and moving part hazards.
Exercise caution when prepare the system for servicing.
CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow the
instructions in this manual and the instructions of reagents.
CAUTION
If the system, when equipped with an ISE module, is going to be powered off for a long
period, the ISE electrodes may be damaged due to water scarcity. Execute the prime
instruction before shutting down the system.
Safety Information-8
Safety Information
Sample Precautions
CAUTION
• Use samples that are completely free of insoluble substances like fibrin or suspended
matter; otherwise the sample probe may be blocked.
• Medicines, anticoagulants or preservative in the samples may lead to unreliable results.
• Hemolysis, icterus or lipemia in the samples may lead to unreliable test results; running a
sample blank, therefore, is recommended.
• Store the samples properly. Improper storage may change the compositions of samples and
lead to unreliable results.
• Sample volatilization may lead to unreliable results. Do not leave the sample open for a
long period.
• The system has a specific requirement on the sample volume. Refer to this manual for
proper sample volume.
• Load samples to correct positions on the sample carousel before the analysis begins;
otherwise reliable results may not be obtained.
CAUTION
• Use proper reagents, calibrators and controls on the system.
• Select appropriate reagents according to the performance characteristics of the system.
Consult the reagent suppliers, our company or our authorized distributor for details, if you
are not sure about your reagent choice.
• Store and use the reagents, calibrators and controls strictly as instructed by the suppliers;
otherwise, reliable results or best performance of the system may not be obtained.
Improper storage of reagents, calibrators and controls may lead to unreliable results and
bad performance of the system even in validity period.
• Perform calibration after changing the reagents, otherwise reliable results may not be
obtained.
• Contamination caused by carryover among reagents may lead to unreliable test results.
Consult the reagent suppliers for details.
Safety Information-9
Safety Information
NOTE
The system automatically stores the data to the built-in hard disk. Data loss, however, is still
possible due to mis-deletion or physical damage of the hard disk. You are recommended to
regularly archive the data to such medium as CDs.
WARNING
For operating instructions and precautions of the computer and printer, please refer to their
operation manuals.
External equipment connected to the analogue and digital interfaces must be complied with
relevant safety and EMC standards (e.g., IEC 60950 Safety of Information Technology
Equipment Standard and CISPR 22 EMC of Information Technology Equipment Standard
(CLASS B)). Any person, who connects additional equipment to the signal input or output
ports and configures an IVD system, is responsible for ensuring that the system works
normally and complies with the safety and EMC requirements. If you have any questions,
consult the technical services department of your local representative.
WARNING
Make sure the air pump tubing is connected properly without any twists or sharp angles so
that it can work normally.
Tubing and cables connected to the air pump must be protected to prevent damage and breaks
due to human or other causes.
Set the air pump on a solid flat platform or ground.
Labels
Introduction
The following non-warning and warning labels are used on the product for system
identification and operating instruction.
Safety Information-10
Safety Information
Check the labels regularly for cleanliness and integrity. If any of the labels becomes vague or
peels off, contact our Customer Service Department or your local distributor for replacement.
Non-Warning Labels
Serial number
This symbol, contained in the product label which is attached to the rear cover of the system,
indicates the production serial number of the product.
Date of manufacture
This symbol, contained in the product label which is attached to the rear cover of the system,
indicates the manufacture date of the product.
Safety Information-11
Safety Information
WEEE label
The following definition of the WEEE label applies to EU member states only.
The use of this symbol indicates that this product should not be treated as household waste.
By ensuring that this product is disposed of correctly, you will help prevent bringing potential
negative consequences to the environment and human health. For more detailed information
with regard to returning and recycling this product, please consult the distributor from whom
you purchased the product.
Safety Information-12
Safety Information
Network interface
This symbol located on the network interface indicates the connection between the analyzer
and the operation unit.
Electrical ground
This symbol located on the main power switch indicates an electrical ground.
Safety Information-13
Safety Information
Warning Labels
Biohazard warning
This label indicating the risk of biohazardous infection is located in the following positions:
• Sample probe wash well
• Shielding cover
• High-concentration waste outlet
• High concentration waste tank
Safety Information-14
Safety Information
Laser warning
This symbol and text located near the sample bar code reader and the reagent bar code reader
reminds you of not staring into the laser beam.
Safety Information-15
Safety Information
Safety Information-16
Contents
Preface································································································· iv
Safety Information···················································································· 1
Safety Symbols ...............................................................................................................................................1
Summary of Hazards ......................................................................................................................................2
Introduction.........................................................................................................................................2
Electric Shock Hazards.......................................................................................................................2
Moving Parts Hazards.........................................................................................................................2
Photometer Lamp Hazards..................................................................................................................3
Sample, Calibrator and Control Hazards ............................................................................................3
Reagent and Wash Solution Hazards ..................................................................................................3
Waste Hazards.....................................................................................................................................4
System Disposal Hazards....................................................................................................................4
Fire and Explosion Hazards................................................................................................................4
Precautions on Use .........................................................................................................................................5
Introduction.........................................................................................................................................5
Intended Use .......................................................................................................................................5
Environment Precautions....................................................................................................................5
Installation Precautions.......................................................................................................................5
Electromagnetic Noise Precautions ....................................................................................................6
Operating Precautions.........................................................................................................................7
Maintenance and Servicing Precautions .............................................................................................8
Chemistry Parameter Configuration Precautions................................................................................8
ISE Module Precautions .....................................................................................................................8
I
Contents - Basic Volume
Sample Precautions.............................................................................................................................9
Reagent, Calibrator and Control Precautions......................................................................................9
Data Archiving Precautions ..............................................................................................................10
External Equipment Precautions.......................................................................................................10
External Air Pump Precautions.........................................................................................................10
Labels............................................................................................................................................................10
Introduction.......................................................................................................................................10
Non-Warning Labels.........................................................................................................................11
Warning Labels .................................................................................................................................14
Contents ·································································································I
1 System Description·············································································· 1-1
1.1 Overview .............................................................................................................................................. 1-1
1.2 Installation Requirements and Procedure ............................................................................................. 1-1
1.2.1 Installation Requirements ...................................................................................................... 1-1
1.2.2 Installation Procedure ............................................................................................................ 1-5
1.3 Hardware Structure ............................................................................................................................... 1-6
1.3.1 System Overview................................................................................................................... 1-6
1.3.2 Sample Handling System....................................................................................................... 1-8
1.3.3 Reagent Handling System.................................................................................................... 1-13
1.3.4 Reaction System .................................................................................................................. 1-19
1.3.5 Cuvette Wash Station ........................................................................................................... 1-20
1.3.6 Photometric System ............................................................................................................. 1-21
1.3.7 Mixer Assembly................................................................................................................... 1-22
1.3.8 Operation Unit ..................................................................................................................... 1-24
1.3.9 Output Unit .......................................................................................................................... 1-24
1.3.10 Accessories and Consumables ........................................................................................... 1-25
1.3.11 Data Management Software............................................................................................... 1-25
1.4 Optional Modules ............................................................................................................................... 1-25
1.4.1 Introduction.......................................................................................................................... 1-25
1.4.2 ISE Module.......................................................................................................................... 1-26
1.4.3 Built-in Sample Bar Code Reader........................................................................................ 1-26
1.4.4 RMS..................................................................................................................................... 1-27
1.4.5 Water Supply Module .......................................................................................................... 1-27
1.4.6 External Air Pump ............................................................................................................... 1-29
1.4.7 Other Optional Modules ...................................................................................................... 1-30
1.5 Software Description .......................................................................................................................... 1-30
1.5.1 Main Screen ......................................................................................................................... 1-30
1.5.2 Function Buttons and Program Structure............................................................................. 1-33
1.5.3 Using a Mouse ..................................................................................................................... 1-39
II
Contents - Basic Volume
III
Contents - Basic Volume
IV
Contents - Basic Volume
V
Contents - Basic Volume
VI
Contents - Basic Volume
VII
Contents - Basic Volume
VIII
Contents - Basic Volume
IX
Contents - Basic Volume
X
Contents - Basic Volume
10 Chemistries ····················································································10-1
10.1 Overview .......................................................................................................................................... 10-1
10.2 Special Calculations.......................................................................................................................... 10-1
10.2.1 Introduction........................................................................................................................ 10-1
10.2.2 Defining/Editing a Calculation .......................................................................................... 10-1
10.2.3 Enabling/Disabling Calculations ....................................................................................... 10-3
10.2.4 Deleting User-Defined Calculations .................................................................................. 10-4
10.2.5 Running Calculations......................................................................................................... 10-5
10.3 Panels................................................................................................................................................ 10-5
10.3.1 Introduction........................................................................................................................ 10-5
10.3.2 Defining/Editing a Panel.................................................................................................... 10-6
10.3.3 Deleting Panels .................................................................................................................. 10-7
10.3.4 Running Panels .................................................................................................................. 10-7
10.4 Serum Index...................................................................................................................................... 10-7
10.5 Chemistry Configuration .................................................................................................................. 10-7
10.5.1 Introduction........................................................................................................................ 10-7
10.5.2 Enabling Chemistries......................................................................................................... 10-8
10.5.3 Disabling Chemistries........................................................................................................ 10-9
10.5.4 Customizing Chemistry Display Order............................................................................ 10-10
10.6 Carryover Setup .............................................................................................................................. 10-10
10.6.1 Introduction...................................................................................................................... 10-10
10.6.2 Defining/Editing Carryover Pair...................................................................................... 10-11
10.6.3 Removing a Carryover Pair ............................................................................................. 10-12
10.7 Default Panel .................................................................................................................................. 10-12
10.7.1 Introduction...................................................................................................................... 10-12
10.7.2 Defining the Default Panel .............................................................................................. 10-12
10.7.3 Running Default Panel for Routine Samples ................................................................... 10-13
10.7.4 Running Default Panel for Emergent Samples ................................................................ 10-14
10.8 Masking/Unmasking Chemistries................................................................................................... 10-14
10.8.1 Introduction...................................................................................................................... 10-14
10.8.2 Masking/Unmasking Chemistries.................................................................................... 10-15
XI
Contents - Basic Volume
XII
Contents - Basic Volume
XIII
Contents - Basic Volume
XIV
Contents - Basic Volume
XV
Contents - Basic Volume
XVI
Contents - Basic Volume
XVII
Contents - Basic Volume
XVIII
1 System Description
1.1 Overview
This chapter describes the system in its hardware structure, software screen, installation
requirements and procedures, as well as technical specifications. After reading this chapter,
you will understand the structure, functions and characteristics of the system.
CAUTION
Install the instrument in a place meeting the requirements presented in this section; otherwise,
it will not perform as promised.
Installation environment
• The system is for indoor use only.
• The bearing platform (or ground) should be level (with gradient less than 1/200).
• The bearing platform (or ground) should be able to support at least 450Kg weight.
• The installation site should be well ventilated.
• The installation site should be free of dust.
• The installation side should not be in direct sun.
• The installation site should be kept away from a heat or draft source.
• The installation site should be free of corrosive gas and flammable gas.
• The bearing platform (of ground) should be free of vibration.
1-1
1 System Description
• The installation site should be kept away from large noise and power supply interference.
• Keep the system away from brush-type motors and electrical contact device that is
frequently switched on and off.
• Do not use such devices as mobile phones and radio transmitter near the system.
• The system should be installed in a place with altitude height less than 2000 meters.
Otherwise, an external air pump should be employed.
Power supply
• Connect the system to a power supply meeting the requirements specified in this manual.
For more information, refer to 1.6.2 Power supply (page 1-47).
• The system is provided with a three-wire power cord, which has good grounding
performance.
• The system should be connected to a properly-grounded power socket.
• Grounding voltage must be configured.
WARNING
Make sure the power socket is grounded correctly. Improper grounding may lead to electric
shock or equipment damage. Check if the power sockets outputs voltage meeting the specified
requirements and has a proper fuse installed.
CAUTION
Operating the system in an environment other than the specified may lead to unreliable
test results. If the temperature or relative humidity does not meet the above-mentioned
requirements, use air-conditioning equipment.
CAUTION
The supplied water must meet the requirements of CLSI type II; otherwise insufficiently
purified water may result in misleading test results.
• Flow: no less than 35L/H for continuous flow, and 2L/M for transient peak flow.
• If you use water supply equipment, make sure that the water supply pressure is within
49kPa-392kPa and the length of the inlet tubing is no longer than 10m.
1-2
1 System Description
Chemistry analyzer
Maximum of 1200mm
3 4
Low-conc waste DI water Inlet filter
5 6
7 8 9
BIOHAZARD
Dispose of the waste liquid according to the local regulations.
1-3
1 System Description
Maximum of 3m
Operation
Unit
Analyzing
0.85m
Unit
1.58m
At least 0.5m
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.
1-4
1 System Description
FIL01 Drain
outlet
Low concentration waste
Water tank
OUT1 OUT2 IN
V01
Water inlet
FIL01
Water unit
WARNING
The system should be installed only by technicians of or authorized by our company.
The system should be installed by technicians of or authorized by our company. Before the
technicians arrive, prepare a proper site to install the system.
1-5
1 System Description
Before installation
When you receive the package, check it carefully. If you find any signs of mishandling or
damage, file a claim immediately with our Customer Service Department or your local
distributor.
After opening the package, check the delivered goods against the packing list, and then
visually check the system appearance. If you find anything missing or damaged, alert our
Customer Service Department or your local distributor immediately.
System relocation
If you want to relocate your system, contact our Customer Service Department or your local
distributor.
1-6
1 System Description
(1)
(2) (13)
(12)
(3)
(6)
(1)
(2)
1-7
1 System Description
(12)
(11)
(1) (10)
(9)
(8)
1-8
1 System Description
are numbered the first, the second, the third and the fourth from the outside inwards.
• The first three rings are equipped with a bar code reader and used to hold routine and
STAT samples. STAT samples are indicated with the letter “E”.
• The fourth ring is intended for calibrators and controls (respectively indicated by letters
“S” and “C”), and also holds routine and STAT samples. This ring provides a
refrigerating environment and does not support bar code scanning. Position D4 (No.139)
is intended for ISE wash solution and position W2 (No.140) for physiological saline used
for reagent blank measurement.
• Position D3, located on the upper-left corner of the sample carousel, is intended for
sample probe wash solution.
All positions on the sample carousel other than positions D4(No.139) and W2(No.140) can be
used to hold samples, calibrators and controls.
Figure 1.7 Sample carousel
1-9
1 System Description
(1)(2)
When the sample load button is pressed in any of the following conditions, the corresponding
sample carousel will rotate counterclockwise for 1/4 circle. The two load buttons are disabled
in other circumstances.
1-10
1 System Description
1-11
1 System Description
The sample probe is capable not only of aspirating sample but also of the following functions:
• Clog detection: checks the sample probe for blockage. When detecting blockage, the
system produces a warning and prompts you with the next step.
• Horizontal obstruction detection: detects obstacles in the horizontal direction. When
the sample probe collides with an obstacle in the horizontal direction, the auto guard
system is started to prevent the sample probe from being damaged.
• Vertical obstruction detection: detects obstacles in the vertical direction. When the
sample probe collides with an obstacle in the vertical direction, the auto guard system is
started to prevent the sample probe from being damaged.
• Level detection and tracking: detects the sample level and determines the depth of
lowering down into the sample based on the specified aspirate volume.
WARNING
When the system is in operation, do not place any part of your body or any obstacle in the
route where the sample probe arm moves; otherwise, personal injury or equipment damage
may be caused.
Sample probe washing
The sample probe is cleaned in its wash well with preheated water spraying its interior and
exterior from two opposite directions.
Sample syringe
The sample syringe is located behind the right door of the analyzing unit. When you open the
right door, you will see three syringes. The syringe on the right is intended for sample
aspirating and dispensing.
Figure 1.11 Sample syringe
(1)
1. Sample syringe
1-12
1 System Description
Sample containers
Sample containers are used to hold samples. The four rings of the sample carousel support
different types of sample container.
The first and the second rings are compatible with the following sample containers:
• Microtube: Mindray sample cup
• Primary tube or plastic tube: Φ12×68.5mm, Φ12×99mm, Φ12.7×75mm, Φ12.7×100mm,
Φ13×75mm, Φ13×95mm, and Φ13×100mm.
The third ring is compatible with the following sample containers:
• Microtube: Mindray sample cup
• Primary tube or plastic tube: Φ12×68.5mm, Φ12×99mm, Φ12.7×75mm, Φ12.7×100mm,
Φ13×75mm, Φ13×95mm, Φ13×100mm, Φ16.5×92mm, Φ16×75mm and Φ16×100mm.
The fourth ring is compatible with the following sample containers:
• Microtube: Mindray sample cup
Sample tubes varying in specification requires different minimum sample volumes. Each
sample tube must contain the minimum amount of sample; otherwise, correct aspirating
cannot be ensured. The minimum sample volume is the sum of the minimum sample volume
for analysis and the dead volume of the sample container.
The table below shows the dead volume of each type of sample container.
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm
Φ16.5×92mm
Φ16×75mm
Φ16×100mm
1-13
1 System Description
(1) (2)
1. Reagent carousel cover
2. Reagent carousel
CAUTION
Ensure that the reagent carousel is closed while the system is analyzing. Opening the reagent
carousel cover during analyzing will abort the analysis and invalidate the tests that are
running.
1-14
1 System Description
(1) (2)
1-15
1 System Description
WARNING
The light radiated from the reagent bar code reader may hurt your eyes. Do not stare into the
laser beam coming from the reagent bar code reader.
1-16
1 System Description
(1)
(2) (8)
(7)
Reagent probe
The system has two reagent probes: probe R1 and probe R2. The former is used to
aspirate/dispense R1 and R3 reagents, and the latter to aspirate/dispense R2 and R4 reagents.
The two probes aspirate reagent within the following range:
• R1 and R3: 15μl-300μl, with increment of 0.5μl
• R2 and R4: 15μl-300μl, with increment of 0.5μl
The reagent probes are capable not only of aspirating reagent but also of the following
functions:
• Horizontal obstruction detection: detects obstacles in the horizontal direction. When
the reagent probe collides with an obstacle in the horizontal direction, the auto guard
system is started to prevent the reagent probe from being damaged.
• Vertical obstruction detection: detects obstacles in the vertical direction. When the
reagent probe collides with an obstacle in the vertical direction, the auto guard system is
started to prevent the reagent probe from being damaged.
• Level detection and tracking: detects the reagent level and determines the depth of
lowering down into the reagent based on the specified aspirate volume.
WARNING
When the system is in operation, do not place any part of your body or any obstacle in the
route where the reagent probe arm moves; otherwise, personal injury or equipment damage
may be caused.
1-17
1 System Description
(1) (2)
1. R1 syringe
2. R2 syringe
R1 syringe is used to aspirate/dispense R1 and R3, and R2 syringe to aspirate/dispense R2 and
R4.
Reagent bottle
The reagent carousel is compatible with 20ml and 62ml reagent bottles. Only one reagent
bottle can be held in each reagent position.
1-18
1 System Description
Reaction carousel
The reaction carousel is a turntable located in the middle of the analyzer panel and provides
165 positions for cuvettes. It holds reaction cuvettes and transmits each of them to the
photometric position for signal detecting and absorbance calculation.
The reaction carousel is capable of temperature control and provides a constant environment
at 37±0.3°C with fluctuation of ±0.1°C.
1-19
1 System Description
(1) (2)
1. Reaction carousel
2. Reaction cuvette
Reaction cuvette
The reaction cuvette is made from permanent glass and used to hold reaction mixture for
photometric measuring. The light pathlength of the cuvette is 5mm, and its inside dimension
is 5mm(length)*5mm(depth)*29mm(height). The total volume of reaction mixture should be
within 100μl-360μl.
When finishing a test, the system washes and dries the cuvette automatically for later use.
1-20
1 System Description
(11)
(10)
(9)
1-21
1 System Description
The signal detection assembly consists of the AD conversion component and the AD signal
collection component. It converts the monochromatic light transmitted through the reaction
mixture into an electrical signal, which is amplified and output as photometric data and then
sent to the corresponding control unit for absorbance calculating.
The table below shows the main technical parameters of the photometric system.
1-22
1 System Description
1-23
1 System Description
1-24
1 System Description
1.4.1 Introduction
Optional modules are not provided as standard configuration accompanying the instrument
when it is delivered. They can be configured according to your requirements. The following
modules are supplied:
• ISE module
• Built-in sample bar code reader
• Remote maintenance system (RMS)
• Water supply module
• External air pump
1-25
1 System Description
(5)
1-26
1 System Description
WARNING
The light radiated from the sample bar code reader may hurt your eyes. Do not stare into the
laser beam coming from the sample bar code reader.
1.4.4 RMS
The remote maintenance system (RMS) is intended for remote maintenance and diagnosis of
the system and for upgrading the software and chemistry parameters. The RMS communicates
with the operating software through the TCP/IP port with static IP address.
For the operating instructions of the RMS, refer to 14.6 Use of RMS (page 14-12).
1-27
1 System Description
(1) (5)
Chemistry analyzer
DI water tank
Fixed by tube
clamps
1 2
Water supply
3 4 inlet filter
5 6 7: Water inlet
Sufficient deionized water should be prepared in the water tank when using the water supply
module. Make sure the water supply module is powered on before running. The module
should be powered off if not used for a long time.
1-28
1 System Description
(1)
(2)
1. Pressure gauge
2. Dust screen
(1)
(3)
(2)
(4)
(5)
Before using the air pump, connect the gas connector and control interface with the
counterpart connectors on the rear panel of the analyzer; connect the air pump to the power
supply with the three-wire power cord. The air pump will be controlled by the analyzer when
powered on and requires no manual operations. When finishing all tests everyday, you are
recommended to power off the air pump.
The pointer of the pressure gauge is deviated from the 0 point when the air pump works
normally. If the pointer stops at the 0 point while the air pump is running, there must be
1-29
1 System Description
something wrong with the air pump. Consult our customer service department or your local
distributor.
The air pump should be installed and adjusted only by the technicians of or authorized by our
company.
(1)
(2) (4)
(3)
1-30
1 System Description
1-31
1 System Description
• : used to program patient samples and control samples, and view sample carousel
status.
• : used to recall and handle error logs, deleting/editing logs and operation logs.
Function window
The function window contains options, buttons and other controls used to perform various
functions of the system.
• : Start icon. Select it to display the Start Conditions window, on which you are
allowed to start new analysis or resume early testing.
1-32
1 System Description
• : Sample Stop icon. Select it to stop sample dispensing. And then you are allowed to
load new samples or replenish samples.
• : Emergency stop icon. Select it to stop all tests. All tests that are running will be
invalidated.
• : STAT icon. Select it to display the STAT Sample Program window, on which you
are enabled to program emergency samples quickly.
• : Online help icon. Select it to display the online help of the current window, where
you will find description of parameters and operations.
1-33
1 System Description
Select Options F2
Rerun F4
Batch Exit F7
Close Save F8
Clear F5 Current Sample
Sample(s) with Following IDs
Sample List Search F1
List F6 Unpositioned F2
Print F7
Exit F8
Chemistry
List Print F7
Exit F8
Download F7 All Programmed Samples
Save F8 All Latest Samples
Sample(s) with Following ID(s)
Sample with Following Bar Code
Quality Prev F4 OK
Control Next F5 Cancel
Discard F7
Save F8
Status Search F1
Log F2
Release F3 Following Position(s)
Result F4 All Positions
1-34
1 System Description
Rotate F1
Reagent/
Load F1 Unload F2
Calibration
Prev F4
(Biochemistry) Next F5
Discard F6
Save F7
Close F8
No Load F2 Check
Rgt Options F3 Check Reagent Inventory
Add Close
Load List F4 Reagent Set
Cal F5 Remove
No Cal F6 Close
Print F7 Calibration Setup Discard F6
Cal Options F8 Save F7
Close F8
Calibrator Definition Define F1
Extend Calibration Time Edit F2 Save
Calibration Override Dilute F3 Edit
Import F4 Delete
Delete F5 Close
Discard F6
Biochemistry Reagent F1 Save F7
Search F1 Prev F4
Calibration Close F8
Cal Curve F2 Next F5
Recalculate F6 Reac Curve F1
Discard F6
Save F7
Print F7 Close F8
Close F8
Sample Blank
Reac Curve F3 Reaction Curve
Prev F4
Reaction Data
Next F5
Save Print F7
Edit F4
Discard Close F8
Archive F5
Close
1-35
1 System Description
Levey-Jennings Search F1
Chems F2
Prev F4
Next F5
Delete F6
Print F7
Twin-Plot Search F1
Chems F2
Prev F4
Next F5
Print F7
Results Search F1
Chems F2
Sort F3
Reac Curve F4 Reaction Curve Sample Blank F2
Comment F5 Reaction Data Prev F5
Archive F6 Next F6
Print F7 Print F7
Close F8
Summary Search F1
Chems F2
Print F7
Define
Setup Define F1
OK
Chems F2
Cancel
Rules F3 OK
Exit
Delete F6 Cancel
Discard F7 Exit
Save F8
1-36
1 System Description
Restore Defaults
Slope/Offset F5 Save
Discard
Close
Define F1
Calculations F6 Delete F2
Print F7
Close F8
Panels F7 Define F1
Delete F2
Print F7
Close F8
Carryover F8 Delete F5
Discard F6
Save F7
Close F8
System
Instrument F1 1. Sleep Setup
Setup
2. Mask/Unmask Chem
3. Sample Comment
4. Com Setup
5. Language
6. Version Upgrade
7. Version Info
8. Date/Time
9. QC Evaluation
10. Auto Release Sample
Exit
1-37
1 System Description
1-38
1 System Description
Log Off
Sleep
Shut Down
OK
Cancel
Demog F1 Prev F4
Next F5
STAT Discard F6
Save F7
Exit F8
Options F2
Chems F3 Set Defaults F3
Save F7 Save F7
Close F8 Close F8
Select
Move the mouse to make the pointer lap over the object that you want to select or edit, and
then press the left mouse button and release it quickly. Pressing the left mouse button is
functionally equivalent to touching the screen.
Double-click
Move the mouse to make the pointer lap over the object that you want to select or edit, and
then quickly press the left mouse button twice and release it. Pressing the left mouse button
twice is functionally equivalent to touching the screen twice.
1-39
1 System Description
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the mouse to
make it stop over the slider, press and hold the left mouse button, move the mouse left and
right to adjust the slider to the desired scale.
Move
Put your finger above the mouse pointer, and then move your finger to make the pointer stop
at the object that you want to select or edit.
Select
Move your finger to make the pointer lap over the object that you want to select or edit, touch
the screen and then release it quickly. Touching the screen is functionally equivalent to
pressing the left mouse button.
Double-click
Move your finger to make the pointer lap over the object that you want to select or edit,
quickly touch the screen twice and then release it. Quickly touching the screen twice is
functionally equivalent to pressing the left mouse button twice.
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the mouse
pointer to make it stop over the slider, press and hold the screen, and then move the pointer
left and right to adjust the slider to the desired scale.
1-40
1 System Description
• Select the icon on the upper right corner to display the help topic related to the
current screen.
Figure 1.36 Accessing the online help from the main screen
1-41
1 System Description
• Select the icon in front of each maintenance instruction or item to display the
relevant operating instructions.
Figure 1.37 Accessing the online help from the Maintenance window
• Select the icon in front of each error log to display the corresponding topic.
Figure 1.38 Accessing the online help from the Error Log screen
1-42
1 System Description
• Press the shortcut combination key Alt+F1 to display the topics related to the current
screen or window.
• Select the button on the upper right corner of the main screen, or press the
shortcut combination key Alt+F1.
• To view details of an error log, select the icon in front of the error log.
1-43
1 System Description
2. Read the help topics. Move the scroll bar on the right side of the help window to view
more information.
1. Select the icon on the upper right corner of the main screen, or press the shortcut
3. Read the help topics. Move the scroll bar on the right side of the help window to view
more information.
1-44
1 System Description
Parameter Description
Throughput for ISE 200 samples/hour, and 600 tests/hour (including K, Na,
chemistries Cl)
Routine and ISE chemistries 1200 tests/hour
Principles of analysis Colorimetry, turbidity, and ISE method
Reaction types Endpoint, fixed-time, and Kinetic
Reagent mode Supporting single-/double-/triple-/quadruple-reagent
tests
Wavelength Supporting double-wavelength mode
1-45
1 System Description
Parameter Description
Reagent probe Two reagent probes available for R1/R3 and R2/R4,
featuring level detection, horizontal/vertical obstruction
detection, and level tracking.
Reagent probe washing The reagent probe is cleaned in its wash well with
preheated water spraying its interior and exterior from
two opposite directions.
Mixer assembly
Reaction system
Photometric system
1-46
1 System Description
Water consumption
Less than 35L/H
Storage environmental
• Temperature: 0°C-40°C
• Relative humidity: 30%-85%, without condensation
1-47
1 System Description
• LIS: HL7 and ASTM1394 (communicating through the TCP/IP interface of static IP
address)
1-48
1 System Description
Parameter Description
Work type Continuous
Protection against poisonous Common device
liquid
Sterilization method Not applicable
recommended by the
manufacturer
Safety degree (classified Not applicable to use in places with combustible
according to the use in anesthetic gases
environment where
combustible anesthetic gases
are mixed with air, oxygen or
nitro-monoxide)
1-49
1 System Description
1-50
2 General Operating Procedure
2-1
2 General Operating Procedure
1. Check the deionized water tank or other water reservoirs, and make sure that water can
be supplied continuously.
2. Check if the connections between the water supply, water supply module, and analyzer
are correct and tight, and the length of the inlet tubing does not exceed 10m.
1. Check if the power supply is available and can provide correct voltage:
2. Check the connections among the analyzing unit, operation unit and printer. Make sure
the connections are correct and secure. Check the power cords of the analyzing unit,
operation unit and printer and make sure they are well connected to the power sockets.
2-2
2 General Operating Procedure
BIOHAZARD
While checking the waste tanks and tubing, wear gloves and lab coat, if necessary, goggles.
1. Check if the high-concentration waste tank has been emptied. If not, empty it.
2. Check if the low-concentration waste tubing is not bent and the sewer opening is lower
Chemistry analyzer
Maximum of 1200mm
1 2
3 4
Low-conc waste DI water
5 6
Inlet filter
Drain outlet
2-3
2 General Operating Procedure
1. Check the diluted wash solution placed on the analyzer panel and in sample and reagent
2. Open the front door of the analyzer and check the concentration wash solution. If
2-4
2 General Operating Procedure
2.3 Powering On
1. Turn on the main power switch (at lower right corner of the system) of the analyzer.
(1)
2-5
2 General Operating Procedure
(1)
5. Turn on the display monitor of the computer installed with the Data Management
Software.
1. When the operation unit (computer) is turned on, the operating software will run
automatically.
If the system detects that the hardware and software environments of the computer do
not meet the requirements, a prompt message will appear to ask for your confirmation to
convert the screen resolution. If you cancel the conversion or the conversion is failed,
you are allowed to abort the startup or reboot the system.
2. Enter the username and password in the Login window, and then select OK.
2-6
2 General Operating Procedure
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when logging
on the system for the first time in order to prevent others from abusing the privileges of
the administrator.
If an operator forgets his password, he may ask the administrator to log on the system
and delete the username and then redefine a username; or he may contact our customer
service department or your local distributor. If the administrator forgets his password,
contact our customer service department or your local distributor.
3. When the startup check is passed, the main screen shows, and a message box is
The system will display prompt message when detecting unsatisfied environment during
the startup process. Please take actions according to the instructions in the message box.
4. When the initialization is finished, the message box is closed. The startup procedure is
finished.
CAUTION
To ensure accurate test results, do not start measurement until the system status turns to
Standby and the system has been turned on for about 20 minutes, so that the light source
and reaction temperature gets steady.
2-7
2 General Operating Procedure
LIS status
Check the LIS status indication in the system status area of the main screen:
• If it appears in yellow, it indicates that a warning occurs. Proceed to the next step.
• If it appears in red, it indicates that an error occurs, or both warning and error occur.
Proceed to the next step.
2-8
2 General Operating Procedure
3. New alarm messages are indicated by corresponding colors. Select the help button in
• If it appears in yellow, it indicates that a warning occurs. Proceed to the next step.
• If it appears in red, it indicates that an error occurs, or both warning and error occur.
Proceed to the next step.
2-9
2 General Operating Procedure
3. View the reagent status. When a reagent is insufficient or exhausted, the corresponding
• Yellow: indicates that the reagent is insufficient or expired, and the analysis will
continue. Refill or replace the reagent.
• Red: indicates that the reagent is exhausted, and the analysis is stopped. Refill or
replace the reagent.
4. View the calibration status. When the calibration is succeeded or failed, the Cal Status
• Yellow: indicates that the calibration factors of the chemistry have been calculated,
or extended, edited or overridden.
• Red: indicates that the calibration of the chemistry is failed or expired.
The calibration time left is the minimum between the chemistry’s calibration time left
and the reagent blank time left. The chemistry’s calibration time left is “Calibration
validity period – (Current date – Calibration date)”; the reagent blank time left is
“Reagent blank validity period – (Current date – Reagent blank date)”.
2-10
2 General Operating Procedure
For more information about calibration, refer to 2.6 Calibration (page 2-23).
1. Check the Utility button on the left of the main screen. If it appears in yellow, it
2. Select Utility-Maintenance-Maintenance.
3. Check if the Scheduled Maintenance tab and maintenance frequency tabs appear in
yellow. If they do, it indicates that at least one maintenance procedure is expired.
4. Select the maintenance frequency tab appearing in yellow, find the expired maintenance
5. Repeat steps 3 and 4 until the maintenance frequency tabs and maintenance procedures
Checking subsystems
1. Select Utility-Status.
2-11
2 General Operating Procedure
2. Check the status options on the Status Summary tab and the subsystem tabs and see if
2-12
2 General Operating Procedure
be rotated, and the system status remains Sleep after reagents are loaded. Before loading
reagents, print out the reagent list and then load reagents according to it. When all reagents
are loaded, the system will check the reagent inventory during measurement and then display
it on the Reagent/Calibration screen. You are recommended to perform inventory check
manually after loading reagents; otherwise, the tests left will not be displayed on the
Reagent/Calibration screen.
If the instrument has set open channels when leaving the factory, the open reagent channels
can only be used to hold reagents of Mindray or of other manufacturers, and the remaining
positions are closed channels and can only hold Mindray reagents. If you want to change the
number of open channels, contact our customer service department or your local distributor.
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
1. Select Reagent-Reagent/Calibration.
2. Select Print F7 to print the load list of ISE reagents, wash solutions and physiological
saline.
3. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
4. If you want to view reagents of the special feature, sort them by position, chemistry,
chemistries left and days left. Click the corresponding header of the reagent list to finish
sorting.
2-13
2 General Operating Procedure
Manual load
When loading reagents manually, you need to enter the reagent information, which is the only
information source of the loaded reagents. You are allowed to input reagent information
before, during or after loading reagents to the reagent carousel. If loaded reagents are
bar-coded, the reagent information cannot be edited; otherwise, all reagent information except
for position, chemistry and reagent type can be edited. Bar-coded reagents that are loaded
manually are deemed auto-loaded reagents. Manually loaded reagents have the letter
“M”(Manual) appearing near them.
Figure 2.6 Flag for manually loaded reagents
(1)
2-14
2 General Operating Procedure
2. Select Reagent-Reagent/Calibration.
3. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
• Bar code
• Chemistry name (required)
• Reagent type (required)
• Lot number
• Serial number
• Bottle type (required)
• Expiration date
CAUTION
If the system is running tests, after requesting reagent stop do not remove the reagent
carousel cover until the countdown for reagent stop is 0 and the system status is Reagent
Load; otherwise, the tests currently run will be invalidated.
9. Load reagents according to the reagent load list. Place R1 and R3 in positions 1-68 of the
outer ring, and then place R2 and R4 in positions 1-49 of the inner ring.
2-15
2 General Operating Procedure
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
Auto load
Auto load is to load bar-coded reagents to the reagent carousel, which are identified by bar
code scanning.
The closed reagents can only be loaded through bar code scanning.
CAUTION
If the system is running tests, after requesting reagent stop do not remove the reagent
carousel cover until the countdown for reagent stop is 0 and the system status is Reagent
Load; otherwise, the tests currently run will be invalidated.
3. Place R1 and R3 in positions 1-68 of the outer ring, and then place R2 and R4 in
2-16
2 General Operating Procedure
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
The system scans all reagent positions automatically and read the following reagent
information from the bar code:
• Chemistry name
• Reagent type
• Days left
• Lot number
• Serial number
• Bottle type
2. Select Reagent-Reagent/Calibration.
2-17
2 General Operating Procedure
(1)
(1) Concentrated wash solution
• Volume % (required)
• Serial number
• Expiration date
• Lot number
9. Select Load.
2-18
2 General Operating Procedure
2. Select Reagent-Reagent/Calibration.
6. Place wash 1 in position D1 (No.70) of the outer ring and wash 2 in position D2 (No.50)
(1) (2)
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
• Volume (%)
• Serial number
• Expiration date
2-19
2 General Operating Procedure
• Lot number
• Bottle type (required)
• Running: Select the button on the upper-right corner of the main screen to
stop sample aspirating and dispensing. When the countdown for sample stop
becomes 0 and the system status is Sample Load, proceed to the next step.
• Incubation: Proceed to the next step.
• Sleep: Select Utility-Commands-Wake Up to awake the system, and then start
loading reagents.
2. Select Reagent-Reagent/Calibration.
5. Place sample probe wash in position D3 on upper left corner of the sample carousel.
2-20
2 General Operating Procedure
7. Select Load.
8. Select Exit to close the window.
2. Select Reagent-Reagent/Calibration.
2-21
2 General Operating Procedure
CAUTION
If the system is running tests, after requesting reagent stop do not remove the reagent
carousel cover until the countdown for reagent stop is 0 and the system status is Reagent
Load; otherwise, the tests currently run will be invalidated.
6. Place the physiological saline in position W1 (No.69) of the outer ring of the reagent
carousel.
Figure 2.10 Position for physiological saline
(1)
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
• Volume %
• Bottle type
2-22
2 General Operating Procedure
2.6 Calibration
Running calibration is to calculate calibration factors for sample result calculation. Generally,
calibration is required when one of the following conditions occurs:
• A new chemistry is configured.
• QC alarms are given while the reagent, calibrator and control sample are within the
expiration date.
• Reagent lot or bottle is changed.
• The calibration factors of a chemistry are expired.
• The ISE electrodes are adjusted or the ISE module is maintained.
• The calibration rules are changed, such as calibration method, replicates, concentration
and calibrator.
• The chemistry parameters are changed, such as primary wavelength, secondary
wavelength, blank time, reaction time, reagent volume(R1/R2/R3/R4), sample volume,
sample dilution parameters, reaction type, reaction direction, sample blank and result
unit.
• The lamp, syringe or sample probe is replaced.
For more information about calibration setup, refer to 3.4 Calibration Setup (page 3-26).
1. Select Reagent-Reagent/Calibration.
2. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
2-23
2 General Operating Procedure
5. Select Calibration.
6. Select OK.
2-24
2 General Operating Procedure
3. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
7. Select Calibration.
8. Select OK.
Auto calibration
The system provides the auto calibration option. When the conditions are satisfied, the system
displays a message indicating calibration required and then stops running the corresponding
chemistry. The conditions for auto calibration include:
• Calibration factors are expired
• Reagent lot is changed
• Reagent bottle is changed
For more information about auto calibration, refer to 6.5 Auto Calibration (page 6-12).
BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not touch the
calibrators directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the calibrators, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.
1. Select Reagent-Reagent/Calibration.
2. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
2-25
2 General Operating Procedure
The calibrator list shows all requested chemistries as well as calibrators, positions,
concentration, lot number and expiration date.
NOTE
Calibrators of a chemistry must be placed and analyzed on the same sample carousel.
1. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
Figure 2.12 Start Conditions window
2-26
2 General Operating Procedure
2-27
2 General Operating Procedure
• If the control has never been programmed, all chemistries assigned for it will be
selected.
• If the control has been programmed, the chemistries in recent programming will be
selected automatically.
The options include all positions defined for the control. The default is the position on
the first defined sample carousel in ascending numerical order. For more information
about control position assignment, refer to 3.5.2 Defining/Editing a Control (page 3-34).
If the chemistries included in a panel are set up for QC parameters, they will be selected
automatically; otherwise, the panel can be selected but will not be programmed for
quality control.
7. To program other controls, select Prev F4 or Next F5, and then repeat steps 3 and 5.
BIOHAZARD
Inappropriate handling of control samples may lead to biohazardous infection. Do not touch
the control samples directly with your hands. Wear gloves and lab coat, if necessary, goggles.
In case your skin contacts the control samples, follow standard laboratory safety procedure
and consult a doctor.
CAUTION
Do not use expired control samples; otherwise, unreliable test results may be caused.
1. Select Program-Sample.
2-28
2 General Operating Procedure
The sample list shows all programmed patient samples, control samples and chemistries,
including the following information:
• Program date and time
• Sample ID or control name
• Position
• Patient name (of patient samples)
• Chemistry
• Sample status
5. Load control samples to the sample carousel according to the printed list.
1. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
Figure 2.14 Start Conditions window
2-29
2 General Operating Procedure
2. Select 9 QC Evaluation.
• Number of samples
• When calibrated
For more information about auto QC setup, refer to 7.3 Auto Quality Control (page 7-6).
4. When the specified number of samples containing the chemistry is finished or a reagent
is calibrated, the system will insert the control sample in the test queue.
Programming a sample
1. Select Program-Sample.
2-30
2 General Operating Procedure
A sample position consists of Crsl and Pos. Routine samples can be programmed with
virtual sample carousel. Up to 10 virtual sample carousels are provided, and the
programming on each day starts from position No.1 of sample carousel 1. Occupied
positions must not be used for programming before being released.
Up to 30 characters can be entered. You are allowed to define sample comments on the
System Setup screen.
2-31
2 General Operating Procedure
2-32
2 General Operating Procedure
7. Choose desired panels. When selected, the panels will appear in a blue frame.
9. Choose a sample volume in the sample option area. The options include standard,
10.Choose a sample tube type. The options include micro and standard.
11.Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
2-33
2 General Operating Procedure
The input range is 4-201, and the default is blank. When dilution factors for both normal
run and rerun are defined, the product between the two factors and the auto dilution
factor must not be greater than 201.
14.If you want to run a chemistry with different sample volume, replicates and predilution
factor, enter the values in the chemistry option area:
• Sample Vol: sample volume required to run the chemistry. The sample volume is
the same as that defined for the chemistry. If increased and decreased volumes are
defined for the chemistry, Increased and Decreased are available here for selection.
• Replicates: number of times the chemistry is to be run.
• Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When dilution factors for both normal run and rerun are
defined, the product between the two factors and the auto dilution factor must not be
greater than 201.
15.Select OK.
16.Select Save F8.
Batch programming
A maximum of 500 samples can be programmed for each batch. For batch-programmed
samples, all program information such as sample information, chemistries and patient
demographics other than position, ID and bar code are the same.
1. Select Program-Sample.
2-34
2 General Operating Procedure
10.Select OK.
11.Select Options F2.
Figure 2.18 Options window
12.Select sample volume in the sample option area. The options include standard, increased
and decreased.
13.Select a sample tube type. The options include micro and standard.
14.Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
2-35
2 General Operating Procedure
17.If you want to run a chemistry with different sample volume, replicates and predilution
factor, enter the values in the chemistry option area:
• Sample Vol: sample volume required to run the chemistry. The sample volume is
the same as that defined for the chemistry. If increased and decreased volumes are
defined for the chemistry, Increased and Decreased are available here for selection.
• Replicates: number of times the chemistry is to be run.
• Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When dilution factors for both normal run and rerun are
defined, the product between the two factors and the auto dilution factor must not be
greater than 201.
18.Select OK.
19.Select Save F8.
1. Select Program-Sample.
2-36
2 General Operating Procedure
4. To change the priority of the sample, select or deselect the STAT checkbox.
The options include Male, Female and Blank. The default is Blank.
9. Enter the patient age in the Age field and select age unit in the pull-down list.
The unit options include year, month, day and hour. The default is year.
2-37
2 General Operating Procedure
1. Select Program-Sample.
2-38
2 General Operating Procedure
• ID
• Position (carousel and position)
• STAT property
• Sample type
• Comment
• Chemistries
• Panels
• Patient demographics
• Sample options and chemistry options
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1. Select Program-Sample.
The sample list shows all programmed samples, controls and chemistries, including the
following information:
• Program date and time
• Sample ID or control name
• Position
• Patient name of patient samples
• Chemistry
2-39
2 General Operating Procedure
• Sample status
While loading samples, press the load buttons near the sample carousel to rotate the
inner and outer carousel for convenient loading.
1. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
Figure 2.20 Start Conditions window
3. Select OK.
2-40
2 General Operating Procedure
samples.
8. Choose desired panels. When selected, the panels will appear in a blue frame.
10.Select sample volume in the sample option area. The options include standard, increased
and decreased.
11.Select a sample tube type. The options include micro and standard.
12.Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
2-41
2 General Operating Procedure
15.If you want to run a chemistry with different sample volume, replicates and predilution
factor, enter the values in the chemistry option area:
• Sample Vol: sample volume required to run the chemistry. The sample volume is
the same as that defined for the chemistry. If increased and decreased volumes are
defined for the chemistry, Increased and Decreased are available here for selection.
• Replicates: number of times the chemistry is to be run.
• Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When dilution factors for both normal run and rerun are
defined, the product between the two factors and the auto dilution factor must not be
greater than 201.
16.Select OK.
17.Select Save F8.
1. Select Program-Sample.
2-42
2 General Operating Procedure
14.Select a sample tube type. The options include micro and standard.
15.Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
18.If you want to run a chemistry with different sample volume, replicates and predilution
factor, enter the values in the chemistry option area:
• Sample Vol: sample volume required to run the chemistry. For batch-programmed
samples, all program information such as sample information, chemistries and
patient demographics other than position, ID and bar code are the same.
• Replicates: number of times the chemistry is to be run.
• Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When dilution factors for both normal run and rerun are
2-43
2 General Operating Procedure
defined, the product between the two factors and the auto dilution factor must not be
greater than 201.
19.Select OK.
20.Select Save F8.
1. Select on upper right corner of the main screen. The STAT Sample Program
window is displayed.
Figure 2.22 STAT Sample Program window
2. Enter the sample ID. The first emergent sample on each day is numbered as 9001.
5. Select a sample tube type. The options include micro and standard.
2-44
2 General Operating Procedure
10.Select sample volume in the sample option area. The options include standard, increased
and decreased.
11.Select a sample tube type. The options include micro and standard.
12.Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
15.If you want to run a chemistry with different sample volume, replicates and predilution
factor, enter the values in the chemistry option area:
• Sample Vol: sample volume required to run the chemistry. The sample volume is
the same as that defined for the chemistry. If increased and decreased volumes are
defined for the chemistry, Increased and Decreased are available here for selection.
• Replicates: number of times the chemistry is to be run.
• Predilution: ratio at which samples containing the chemistry will be prediluted
before being analyzed. When dilution factors for both normal run and rerun are
defined, the product between the two factors and the auto dilution factor must not be
greater than 201.
16.Select OK.
17.Select Close F8 to close the window.
2-45
2 General Operating Procedure
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
2. Press the load buttons near the sample carousel to rotate the inner and outer carousel for
convenient loading.
3. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
Figure 2.23 Start Conditions window
5. Select OK.
2-46
2 General Operating Procedure
screen. To pause or stop analysis, select the and icons on upper right corner of the
main screen.
1. Select Reagent-Reagent/Calibration.
The screen displays the inventory and calibration status of ISE buffer solution, as well as
inventory and days left of wash solution. When the inventory is less than the alarm limit,
the system will give an alarm and mark the chemistry or wash solution name with
different colors.
• Yellow: Warning. The remaining reagent is insufficient.
• Red: Serious. The reagent is exhausted.
The screen displays the inventory and calibration status of the reagents. When the
reagent inventory is less than the alarm limit, the system will give an alarm and mark the
chemistry name and chemistries left with different colors.
• Yellow: Warning. The number of chemistries left is lower than the alarm limit.
2-47
2 General Operating Procedure
• Red: Serious. The number of chemistries left is 0. The chemistry can still be
requested but will not be run. The ongoing tests containing the chemistry will be
invalidated.
When the reagent inventory is less than the alarm limit, the system will give an alarm
and mark the chemistry name with different colors.
• Yellow: Warning. The remaining reagent is insufficient.
• Red: Serious. The reagent is exhausted.
1. Select Program-Status.
2-48
2 General Operating Procedure
2. View the status of calibrators, controls and samples on the sample carousel graph.
• White: The position is not being used for analysis or has been released manually.
• Grey: The sample is programmed but not started for analysis.
• Dark green: The sample is dispensed into a reaction cuvette.
• Red: All chemistries of the sample are run, but one or more of them have no results.
• Green: All chemistries of the sample are run and have test results.
• Blue: The sample is being analyzed.
• : Indicate invalid sample.
− The sigh appears when sample bar code conflicts, or positions of controls and
calibrators are occupied by patient samples, or invalid bar code is detected.
− A bar code is deemed invalid if it contains invalid characters or exceeds the
length limit, or is detected in an idle position but has no corresponding sample
information or default panel for analysis.
− Select Log F2 to find the specific causes.
The detailed information of the selected sample is displayed on the right side of the
screen:
2-49
2 General Operating Procedure
• Sample position
• Sample status
• Program date and time
• Sample ID (patient sample)
• Bar code (patient sample)
• Calibrator name and lot number (calibrator)
• Name and lot number (control sample)
• Search F1: used to search for desired calibrator, control or patient sample.
• Log F2: used to recall controls and patient samples which are not complete due to
some reasons within the recent 24 hours.
• Release F3: used to release the specified or all positions on the current sample
carousel.
• Result F4: used to display the Current Results screen, on which you can recall all
controls and patient samples that are programmed and analyzed since the system is
started up.
Select the icon on upper right corner of the screen, and then select OK. All unfinished
actions of the system are cancelled, all pumps and valves are turned off, and the system enters
the failure status.
To restore system failure, select Utility-Commands, and then select Home. To resume the
analysis, select the icon.
2-50
2 General Operating Procedure
2. Select Exit-Shut Down on the left of the main screen. The Windows operating system
will quit and the analyzing unit power will be switched off automatically.
When the analyzing unit power is switched off, the refrigeration system is still running.
If you are going to store the system for over 7 days, switch off the main power.
• Printer
• Monitor display of the operation unit
• Monitor display of the computer installed with the Data Management Software
• Water supply module
1. Remove the sample carousel cover, and then remove the calibrators, controls and patient
samples.
2. Check the analyzer panel for stains and wipe them off with clean gauze if any.
2-51
2 General Operating Procedure
2-52
3 System Setup
3.1 Overview
This chapter introduces the basic setup options of the system, which include system options,
chemistries, calibration and quality control.
3.2.1 Introduction
This section summarizes the setup options on the System Setup screen as shown in the
figure below.
3-1
3 System Setup
3-2
3 System Setup
Result flag
Reference range is only applicable to open-reagent chemistries and should be set up when a
chemistry is defined. When flags are defined for the reference range, the system will display
flags in the Flag column of the Current Results and History Results screens and on
patient reports if the test result is less than or greater than the reference range. The flags can
3-3
3 System Setup
Alarm volume
Alarm tone is the sound of a system alarm and can be adjusted manually according to the
practical conditions of the environment. Drag the slider in the Alarm Volume field
horizontally. The scale is ascending from left to right. When the slider is moved to the
leftmost position, the alarm buzzer is silenced.
Sleep setup
The Sleep Setup option is used to set up the auto sleep time interval, and the auto
awake/shutdown time of the system.
If the auto sleep time interval is set up, the counter will start counting down once the system
enters Standby status and begins to sleep when the countdown is finished.
The system allows you to choose a weekday and specific time that the system will be started
up or shut down automatically. When the awake time is reached, the system will be woken up
3-4
3 System Setup
automatically no matter if it is off or sleeping. When the shutdown time is reached, the system
will shut down automatically if it is running. For more information, refer to 11.6 Auto Awake
and Startup Setup (page 11-7).
Masking/Unmasking Chemistries
The Masking/Unmasking Chemistries option is used to disable chemistries, which will still be
displayed on the Sample, Quality Control and Reagent/Calibration screens. Masked
chemistries can be requested but will not be run for sample analysis.
For details of chemistry masking/unmasking, refer to 10.8 Masking/Unmasking Chemistries
(page 10-14).
Sample comments
It is necessary to add comments to samples during programming so that the samples can be
properly processed in the laboratory. You are allowed to enter sample comments manually on
the Sample screen, or define them on the System Setup screen and then choose one from
the Comment pull-down list on the Sample screen. For more information, refer to 8.8
Sample Comments (page 8-31).
3-5
3 System Setup
4. Enter the IP address for connection between the operation unit and the analyzing unit in
5. Select OK.
Select language
The operating software is displayed by default in the same language as the current operating
software. You are allowed to change the language of the operating software.
Select System Setup-Instrument F1-5 Language, and then choose a language from the
following options: Chinese, English, Turkish, Russian, French, Portuguese, Italian, Spanish,
and Polish. Select OK to save the settings. The language you select will take effect only when
you reboot the operating software.
Software upgrading
By running the upgrade program, you are allowed to upgrade the operating software, control
software and ISE module software. For more information, refer to 11.7 Software Upgrade
(page 11-10).
3-6
3 System Setup
formats to be displayed on software screens and printed reports, and restore default date and
time formats .
When set, the date and time will influence the time left of reagents and calibration, shelf life
of samples, and run length of two-control evaluation. The date and time cannot be edited
when the system status is Running. Modification of the date and time will not affect samples
on the Current Results screen or QC evaluation and Twin-Plot chart.
Follow this procedure to change system date and time:
1. Select Utility-System.
3. Select 8 Date/Time.
Manually enter the hour, minute and second, or move the cursor to hour, minute and
second, and then click the up/down arrows to adjust the time.
3-7
3 System Setup
• Separator: -
3-8
3 System Setup
3.3.1 Introduction
The system supports both closed-reagent and open-reagent chemistries, and up to 200
chemistries can be configured. Closed-reagent chemistries can only be run with the reagents
provided by our company, and must not be edited for parameters other than print name, result
unit, decimal places, error detection limits, auto rerun dilution factor and slope/offset. If you
are not going to use certain closed-reagent chemistries, you are allowed to mask them, and if
needed some day, unmask them. The Chemistries screen is as shown below:
Figure 3.4 Chemistries screen
Definition and setup of user-defined chemistries will be described in detail in the following
sections.
3-9
3 System Setup
4. Enter the processing parameters and error detection limits of the chemistry.
5. Select Dilute F1 to set up the dilution factors for normal and rerun tests.
6. Select Next F5 to save your input information and define more chemistries. Or
1. Select Utility-Chemistries.
3. Select Define F1 to view the processing parameters, error detection limits and dilution
factors.
3-10
3 System Setup
5. Select Ref Range F4 to view the reference range and critical range.
2. Select Utility-Chemistries.
All test results, data and parameters related to the chemistry are cleared.
3-11
3 System Setup
Chem
Chemistry name is the only identity of a chemistry and must not be duplicate. A chemistry
name can be composed of up to 10 characters, which include:
• Letters
• Numbers
• _ (underline)
• + (plus sign)
• - (minus sign)
• * (asterisk)
• / (backlash)
The input is not case sensitive.
No.
No. is a unique number for chemistry. It can be left blank but must not be duplicate.
Chemistry number is composed of numbers and ranges from 0-9999.
Sample type
Sample type refers to the samples to which the chemistry is applicable. The options include
serum, plasma, urine, CSF and other. The options available in the Sample Type pull-down
list are those supported by the chemistry, and the default is the default sample type.
Sample type setup is only applicable to closed chemistries. In case that you are defining an
open-reagent chemistry, the Sample Type icon will not appear, which indicates that the
chemistry supports all sample types.
3-12
3 System Setup
Chemistry
Chemistry is the complete form of chemistry name. It can be composed of up to 36 characters.
The input is not case sensitive. The Chemistry field can be left blank or duplicate.
A chemistry is only represented by its print name on patient reports and appears on other
reports in the form of short name.
Print Name
Print name is displayed on patient reports representing a chemistry. It can be composed of up
to 15 characters. The print name can be edited and duplicate. When this field is left blank, the
short form of the chemistry name will appear on patient reports. A chemistry is represented by
its print name on all reports other than patient reports.
Reaction Type
Reaction type is a measurement theory based on which chemistries are run for samples and
then calculated. The system supports three reaction types, which are Endpoint, Fixed-time and
Kinetic.
Reaction Direction
Reaction direction refers to the change trend of absorbance during the reaction process, and
includes two options:
• Positive: indicates increasing absorbance with time.
• Negative: indicates decreasing absorbance with time.
Primary Wavelength
The primary wavelength is chosen based on the light absorption features of the reactant and
used to measure the absorbed light intensity.
3-13
3 System Setup
Options for primary wavelength include: 340nm, 380nm, 412nm, 450nm, 505nm, 546nm,
570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Secondary Wavelength
The secondary wavelength is used to correct the absorbance measured at the primary
wavelength and eliminate the influence of noise, such as light flash and drift, and scratches on
cuvettes, etc. The two wavelengths cannot be equal.
Options for secondary wavelength include: blank, 340nm, 380nm, 412nm, 450nm, 505nm,
546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Unit
Changing the result units of both closed-reagent and open-reagent chemistries are allowed.
• For closed-reagent chemistries, only the unit options provided by the manufacturer can
be selected. When the result unit is changed, the system will automatically refresh the
finished sample results, calibrator concentrations, control concentrations, reference
ranges and offsets in light of the conversion rate between units.
• For open-reagent chemistries, the result unit is blank by default. After changing the unit,
you are required to update calibrator concentrations, control concentrations and standard
deviations (SDs), reference ranges and offsets. Those test results calculated with the old
unit will remain unchanged.
The following table summaries the result units available for open-reagent chemistries.
3-14
3 System Setup
Decimal
Decimal specifies the number of decimal places for test results. The decimal is allowed to be
edited for both open and closed reagent chemistries. The number of decimal places is 0 for
open chemistry and same as that defined in the database for closed chemistry.
Up to 3 decimal places can be set up and respectively correspond to 0, 0.1, 0.01 and 0.001.
Table 3.3 Blank time and reaction time input ranges for endpoint analysis
Endpoint Blank Time Reaction Time
When the blank absorbance is read before the reaction begins,
Single-reagent 1≤N≤P≤4 5≤L≤M≤33
Double-reagent 5≤N≤P≤16 18≤L≤M≤33
Triple-reagent 18≤N≤P≤35 40≤L≤M≤68
Quadruple-reagent 40≤N≤P≤51 53≤L≤M≤68
When the blank absorbance is read after the reaction begins,
Single-reagent 5≤N≤P P<L≤M≤33
Double-reagent 18≤N≤P P<L≤M≤33
Triple-reagent 40≤N≤P P<L≤M≤68
Quadruple-reagent 53≤N≤P P<L≤M≤68
When the blank absorbance is not subtracted,
Single-reagent N=P=0 5≤L≤M≤33
Double-reagent N=P=0 18≤L≤M≤33
Triple-reagent N=P=0 40≤L≤M≤68
Quadruple-reagent N=P=0 53≤L≤M≤68
3-15
3 System Setup
Table 3.4 Blank time and reaction time input ranges for fixed-time and Kinetic
analysis
Fixed-time and Kinetic Blank Time Reaction Time
When the blank absorbance is read before the reaction begins,
Single-reagent 1≤N<P≤4 5≤L<M≤33
Double-reagent 5≤N<P≤16 18≤L<M≤33
Triple-reagent 18≤N<P≤35 40≤L<M≤68
Quadruple-reagent 40≤N<P≤51 53≤L<M≤68
When the blank absorbance is not subtracted,
Single-reagent N=P=0 5≤L<M≤33
Double-reagent N=P=0 18≤L<M≤33
Triple-reagent N=P=0 40≤L<M≤68
Quadruple-reagent N=P=0 53≤L<M≤68
The blank time and reaction time are almost the same for both fixed-time and Kinetic analysis,
except that M-L≥2 is required for Kinetic analysis, that is, the reaction time should include at
least 3 measuring points.
Sample Blank
Sample blank is similar to sample analysis except for use of equivalent amount of
physiological saline. Sample blank is used for removal of non-chromogenesis reaction, such
as influence of sample interference (Hemolysis, icterus and lipemia) on absorbance readings.
The sample blank reaction curve is almost a straight line with slope of 0 during the reaction
period, and therefore means nothing for fixed-time and Kinetic analysis. For double, triple
and quadruple reagent endpoint analysis, the sample blank absorbance can be subtracted
through parameter settings. Therefore, sample blank is only effective for single-reagent
endpoint chemistries.
Mark the Sample Blank checkbox with a tick. The chemistry will be sample blanked before
the reaction begins.
3-16
3 System Setup
Reagent Volume
Reagent volume specifies the reagent amount, which should be dispensed for measurement.
The system allows the dispensing of four reagents:
• R1: 100μl-300μl, with an increment of 0.5μl. The default is 0.5μl.
• R2: 15μl-300μl, with an increment of 0.5μl. The default is 0.5μl. The default is blank.
• R3: 15μl-300μl, with an increment of 0.5μl. The default is 0.5μl. The default is blank.
• R4: 15μl-300μl, with an increment of 0.5μl. The default is 0.5μl. The default is blank.
The second, third and fourth reagents are allowed only when the reagent(s) prior to them are
configured. For example, R2 can be set up with the prerequisite of R1; R3 with R1and R2; R4
with R1, R2 and R3. If one of R2, R3 and R4 is removed, the remaining reagents behind it
will also be removed and appear in grey.
The combined volume of all reagents and sample must be within 100μl and 360μl. If your
input does not satisfy the requirements of reaction mixture volume, the system will display an
error message. Check the sample volume and reagent volumes you have entered, and change
them if necessary.
3-17
3 System Setup
Linearity Range
The linearity range indicates the measurable range of the system, during which the test result
is linear to the response R. Determine the linearity range according to the reagent package
insert. Enter the linearity range within -34,000-34,000 and make sure that the low limit is
lower than the high limit.
The system compares the calculated sample concentration with the linearity range. When the
high limit is exceeded, the > sign will appear near the result; when the low limit is exceeded,
the < sign will appear. For more information of result flags, refer to 17.5 Data Alarm (page
17-12).
The default is blank, which means not performing this check.
Auto Rerun
The Auto Rerun option is used to rerun the chemistries that are beyond the preset linearity
range.
If you have specified the auto rerun dilution factor on the Sample Dilution Factor window,
the chemistry will be rerun with the sample diluted for the set ratio; otherwise, it will be run
with the standard sample volume.
Mark the Auto Rerun checkbox means enabling the auto rerun option.
For more information about auto rerun, refer to Auto rerun of diluted samples (page 8-9).
Linearity Limit
Linearity limit is only applicable to Kinetic analysis, in which the absorbance change is linear
to the reaction time. If the reagent undergoes substrate depletion, or the photometer fluctuates,
or the reaction mixture is not stirred evenly, the test results may be unreliable. Therefore, the
linearity of the measuring period is calculated and then compared with the set linearity limit.
If the reaction data within the linearity range does not satisfy the linearity limit, the system
will flag the test result with “LIN” on the patient report. For more information of result flags,
refer to 17.5 Data Alarm (page 17-12).
The linearity limit can be any number between 0 and 1 with a maximum of 2 decimals. The
default is blank, which means not performing this check.
Substrate Depletion
The Substrate Depletion option is only applicable to Kinetic and fixed-time analysis. It can be
obtained through the following formula:
Substrate depletion limit = Input substrate depletion limit + K(L1-Lb)
Where,
• L1: refers to the absorbance of primary wavelength measured at the first measuring point
when sample is dispensed and stirred in sample analysis.
• Lb: refers to the absorbance of primary wavelength measured at the first measuring point
when sample is dispensed and stirred in a reagent blank test or calibration with
0-concentration calibrator.
• K: correction factor of liquid volume
3-18
3 System Setup
Results will not be adjusted when L1-Lb≤0 or the measurement is not a reagent blank or
0-concentration calibration. Substrate depletion is not applicable for calibrations.
We deem that substrate depletion occurs if the primary wavelength absorbance of the first
measuring point is greater than the substrate depletion limit in ascending reactions or lower
than the substrate depletion limit in descending reactions. When substrate depletion occurs,
the system will flag the test result with “BOE” in the patient report. For more information of
result flags, refer to 17.5 Data Alarm (page 17-12).
The substrate depletion limit can be any number within -34,000-34,000. The default is blank,
which means not performing this check.
Blank Response
The Blank Response specifies the allowable range of the response in a zero-concentration
calibrator analysis or a reagent blank test. The input range can be any number within
-34,000-34,000, and the low limit lower than the high limit.
If the response is beyond the set range, the system will flag the test result with “BLK”.
The default is blank, which means not performing this check.
Uncapping Time
The Uncapping Time refers to the number of days that the reagent can be kept valid since
uncapped at the first time.
The input range must be within 1-999 days. The default is blank, which means that the
reagent is valid at all times.
Prozone Check
In the reaction of antigen and antibody, the amount of generated insoluble compound is
closely related to the proportion of antigen and antibody. The maximum amount of compound
will be generated at a proper proportion of antigen and antibody, at this point least light is
3-19
3 System Setup
passed and the greatest absorbance is obtained. For other proportions, the amount of insoluble
compound will decrease with more light passed and lower absorbance calculated. Therefore,
samples with quite different concentrations may generate the equivalent amount of insoluble
antigen/antibody compound, and can have the same test results without a Prozone check.
The Prozone check can be performed in two ways: rate check and antigen addition.
• The rate check is based on the condition that the antibody excess reaction rather than the
antigen excess reaction can reach equilibrium within the same specified period. This
method is used for all chemistries.
• With the antigen addition method, more antigens are added to the finished reaction, and
if the reaction does not continue, it indicates antigen excess. This method is only
applicable to single and double reagent chemistries.
Rate check:
You are required to set up the following six parameters for the rate check method, which are
Q1, Q2, Q3, Q4, PC and ABS. The unit is the same as the reaction time and blank time.
Enter the six parameters as follows:
• Single-reagent chemistries: 5≤q1<q2<q3<q4≤33. “5” is the first measuring point after
the sample is dispensed and stirred.
• Double-reagent chemistries: 18≤q1<q2<q3<q4≤33. “18” is the first measuring point after
R2 is dispensed and stirred.
• Triple-reagent chemistries: 40≤q1<q2<q3<q4≤68. “40” is the first measuring point after
R3 is dispensed and stirred.
• Quadruple-reagent chemistries: 53≤q1<q2<q3<q4≤68. “53” is the first measuring point
after R4 is dispensed and stirred.
• PC: a number between 0 and 10, with four decimals.
• ABS: any integer between 0 and 34,000.
Antigen addition:
For the antigen addition method, you need to enter the three parameters, which are Q1, Q2
and PC.
Enter the three parameters as follows:
• Q1: 68≥Q2≥40>Q1≥reaction end point.
• Q2: 68≥Q2≥40>Q1≥reaction end point.
• PC: -34,000-34,000.
3-20
3 System Setup
on the defined concentrations and has nothing to do with the dilution factors of the
chemistries.
Dilution factor setup is not applicable to chemistries of antigen addition.
1. Select Utility-Chemistries.
2. Choose a chemistry.
5. Enter the dilution factor for normal test in the For Normal Run field.
The input range is 4-201, and only integer is allowed. The dilution factor is used for
calibration, quality control and sample analysis of the chemistry.
6. Enter the dilution factor for auto rerun test in the For Auto Rerun field.
The input range is 4-201, and only integer is allowed. Make sure that the product
between the dilution factors for both normal run and rerun is within 4-201.
7. Select Save.
8. Select Close.
3-21
3 System Setup
1. Select Utility-Chemistries.
3. Choose a chemistry.
4. Double click the Slope field and then input the slope.
The slope must be above 0. The default is 1.000. The maximum input length is 8 digits.
5. Double click the Offset field and then input the offset.
3-22
3 System Setup
The default value for offset is 0.000. The maximum input length is 8 digits.
6. Repeat step 3 to 5 to set up the slope and offset for other chemistries.
8. To restore the factory settings of slope and offset, select Restore Defaults.
3-23
3 System Setup
• Enter the reference range low limit in the first edit box.
• Enter the reference range high limit in the second edit box.
• The maximum input length is 8 digits.
• Enter the critical range low limit in the first edit box.
• Enter the critical range high limit in the second edit box.
• The maximum input length is 8 digits.
9. To rerun the chemistry when its test result is beyond the critical range, mark the Auto
3-24
3 System Setup
User-defined calculations cannot be rerun. The Auto Rerun checkbox will appear in
grey if the current chemistry is a calculation.
For more information about auto rerun, refer to Auto rerun based on critical range (page
8-8).
10.Select Save F7. The reference/critical range are displayed in the middle list.
• Select Discard F6 to abort the input information, or
• Select Set Defaults F1 to set the reference/critical range as the default for the
chemistry.
1. Select Utility-Chemistries.
3. Choose the chemistry name, sample type, gender and age range.
The selected reference/critical range is set as the default of the chemistry. The system
will check the test result, and if necessary, flag and rerun the chemistry. For details of
reference range flags, refer to Result flag (page 3-3).
3-25
3 System Setup
3. Choose the chemistry name, sample type, gender and age range.
6. Select OK.
NOTE
The reference/critical range cannot be recovered once deleted. Think twice before the
deletion.
8. Select OK.
3.4.1 Introduction
Perform calibration settings in the following order:
• Define a calibrator
• Set up calibrator concentrations
• Set up calibration rules
• Set up calibrator acceptance limits
You are allowed to add, edit and delete calibrators only when the system status is not
Running.
1. Select Rgts/Cal-Reagent/Calibration.
3-26
3 System Setup
7. Enter the expiration date of the calibrator. The default is the current day in the next year.
The input range is 0-18 and accepts numbers and letters. Calibrators with the same name
must not have the same lot number.
3-27
3 System Setup
1. Select Rgts/Cal-Reagent/Calibration.
• Calibrator name
• Expiration date
• Lot number
• Position
3-28
3 System Setup
1. Select Rgts/Cal-Reagent/Calibration.
The chemistries configured for the calibrator are displayed in the right list.
3-29
3 System Setup
6. Choose chemistries to which the calibrator is applicable, and then select the
corresponding Conc column and type in the calibrator concentration for it.
1. Select Rgts/Cal-Reagent/Calibration.
3-30
3 System Setup
This field is activated only when the one-point linear math model is chosen. When the K
factor is determined, the calibration results will be calculated with the equation Y=K*X.
Where, Y is the calibration result, K is the factor, and X is the response. The K factor can
be used to calculate sample results without running a calibration.
3-31
3 System Setup
1. Select Rgts/Cal-Reagent/Calibration.
3-32
3 System Setup
1. Select Rgts/Cal-Reagent/Calibration.
3-33
3 System Setup
3.5 QC Setup
3.5.1 Introduction
Perform QC settings in the following order:
• Define a control
• Select chemistries
• Set up control concentrations
• Set up QC rules
1. Select QC-Setup.
3-34
3 System Setup
The lot number can be composed of characters or numbers. The combination of control
name and lot number must not be duplicate.
The options include serum, plasma, urine, CSF and other. The default is serum.
When the expiration date is exceeded, the control can still be programmed and analyzed,
while the system flags the test result in the Flag column to remind you of replacing the
expired control.
You are allowed to assign one position of each sample carousel for the control. The
fourth ring (center) of the sample carousel is used to carry calibrators and controls. You
may also place the control on other idle positions of the sample carousel.
3-35
3 System Setup
1. Select QC-Setup.
4. Choose chemistries for the control. Use the right-arrow button to display more
chemistries.
7. Select OK.
3-36
3 System Setup
1. Select QC-Setup.
The chemistries configured for the control are displayed in the right list.
3. Select the Mean column of a chemistry and type in the average concentration for it.
4. Select the SD column of a chemistry and type in the standard deviation for it.
3-37
3 System Setup
1. Select QC-Setup.
5. If you assign a couple of controls for the chemistry, you are allowed to enable the
Those controls not contained in the two-control evaluation will be monitored according
the Westgard rules.
3-38
3 System Setup
7. Enter the average concentration and standard deviation right below the Control(X) field.
9. Enter the average concentration and standard deviation right below the Control(Y) field.
1. Select QC-Setup.
3-39
3 System Setup
3-40
4 Operation Theories
4.1 Overview
The system is a fully automated computer-controlled clinical chemistry analyzer allowing the
random selection of chemistries. It is capable of running a variety of chemistries based on the
operation theories and measurement principles.
The system performs measurement and generates the test results in the following procedure:
Figure 4.1 Measurement workflow
AD value
Absorbance
Response
Calibration factors
QC conclusion
The system measures the light intensity through photoelectric conversion, linear amplification
and AD conversion, and then calculates the reaction mixture’s absorbance and the absorbance
change rate, that is, the response, based on which the calibration factors are obtained. The
system performance is evaluated according to the test results of the control samples. If the
system is working normally, you may start the analysis of patient samples and the system will
calculate the sample results with the calibration factors.
4-1
4 Operation Theories
4.2.1 Introduction
The system performs measurement with the following principles:
• Endpoint
• Fixed-time
• Kinetic
In the description of the following sections, N and P indicate the blank read time range, L and
M indicate the reaction read time range. In double-wavelength measurements, absorbance A is
the absorbance difference between the primary and secondary wavelengths; in
single-wavelength measurements, absorbance A is the absorbance measured at the primary
wavelength.
4.3.1 Introduction
In endpoint measurements, the reaction reaches equilibrium after a period of time. Since the
equilibrium constant is quite high, it can be considered that all substrates (analytes) have
changed into products, and the absorbance of the reactant will not change any more. The
absorbance change is directly proportional to the analytes’ concentration. The endpoint
method, also called equilibrium method, is most ideal for measurements.
The endpoint reaction is insensitive to minor changes in such conditions as the enzyme
volume, pH value and temperature, provided the changes are not significant enough to affect
the reaction time.
4-2
4 Operation Theories
mediate absorbance measured at the three points, while the maximum and minimum
absorbance is removed.
• If M>L+2, the reaction absorbance will be the average of the remaining absorbance
when the maximum and minimum absorbance is removed.
4-3
4 Operation Theories
4.4.1 Introduction
In fixed-time measurements, namely, rate measurements, the reaction velocity (v) is directly
proportional to the substrate concentration [S] within a specific period, that is, v=k[S]. As the
substrate is consumed continuously, the reaction velocity is decreasing gradually, and so is the
absorbance change rate. It takes a long time for the reaction to reach equilibrium.
Theoretically, the absorbance reading can be taken at any time. The reaction can, however,
become steady only after a lag because it is complicated at the beginning and there are
miscellaneous reactions due to complex serum compositions.
For any rate measurements, the substrate concentration [S] at a given point t since the reaction
begins is obtained through the following formula:
[S ] = [S 0 ]× e − kt
Where,
4-4
4 Operation Theories
− Δ[ S ]
[ S 0] = − kt1 − kt 2
e −e
That is, the change in substrate concentration is directly proportional to its initial
concentration within a fixed time interval. This is the common feature of rate measurements.
Within this interval, the absorbance change is directly proportional to the analytes
concentration. The fixed-time reaction is also called, rate reaction, first-order Kinetic reaction
and two-point Kinetic reaction.
It is available in single-interval and double-interval according to the input mode of measuring
points. In the double-interval reaction, the sample blank, which is the absorbance change at
two points within the incubation time, is subtracted from the reaction absorbance.
The fixed-time measurements allow the check of substrate depletion at the two measuring
points. When detecting substrate depletion, the system will flag the test result with “BOE”
and give an alarm.
4-5
4 Operation Theories
4.5.1 Introduction
In Kinetic measurements, namely, zero-order Kinetic measurements or continuous-monitoring
measurements, the reaction velocity is not related to substrate concentration and remains
constant during the reaction process. As a result, the analytes absorbance changes evenly at a
given wavelength, and the change rate (ΔA/min) is directly proportional to the activity or
concentration of the analytes. The Kinetic method is usually used to measure enzyme activity.
In fact, it is impossible for the substrate concentration to be absolutely high, and the reaction
will be no longer a zero-order reaction when the substrate is consumed to certain degree.
Therefore, the reaction type only stands within certain reaction period. In addition, the
reaction can become steady only after a period of time, because the reaction is complicated at
the beginning and there are miscellaneous reactions due to complex serum compositions.
In Kinetic reaction, the concentration or activity is obtained according to the absorbance
change among specified measuring points.
4-6
4 Operation Theories
Enter L and M
Enter substrate
depletion limit?
No
Yes
Yes
Substrate depleted Alarm of 揘 LN
at L+2
No
No
The number (N) of measuring points within the substrate depletion limit is monitored for
different operations:
• If N≥3, the linearity range includes all measuring points from the reaction start point to
the substrate depletion limit; otherwise, the test result will be flagged with “NLN”.
• If N=0 or 1, the enzyme linear extension will be enabled.
• If N=2, the system will give an alarm while using two measuring points for calculating
the response.
∑ (T − T ) ⋅ ( A − A)
i i
ΔA LM' = 60* i = L M
∑ (T − T )
i=L
i
2
4-7
4 Operation Theories
Where,
• L: start point of the linearity range
• M’: end point of the linearity range
• Ai: absorbance measured at measuring point i
• A : average absorbance within L-M’
• Ti: actual measuring time (second) at measuring point i
• T : average measuring time within L-M
If there are less than two measuring points without substrate depletion within the reaction
time, the system will calculate the absorbance change rate by extending the enzyme linearity
range.
Calculation of Response
The response in Kinetic measurements is calculated as follows:
R = ΔA LM' − K ⋅ ΔA NP
k is the calculation factor and varies with the chemistry parameters.
4-8
4 Operation Theories
ΔA f − ΔAb
Linearity= × 100 < Linearity Limit
ΔAu ,v
Where, ΔA f , ΔAb and ΔAu ,v are the absorbance change rates in the front part, back part
and at all measuring points of the reaction. These three values are calculated based on the
number of measuring points within the linearity range.
• When N>8, ΔA f is the absorbance change rate of the first 6 measuring points, ΔAb
of the last 6 measuring points, and ΔAu ,v of all measuring points.
Lag time
Reaction Time
Absorbance
Substrate depleted
In high-activity enzyme measurements, the substrate may be depleted quickly and the reaction
curve will appear obviously nonlinear (as a smooth curve). If the measurement is performed
based on the general procedure, the system will flag the test result with “NLN” (no linearity
interval), reminding the user to rerun the test after diluting the sample. This will more or less
4-9
4 Operation Theories
4-10
4 Operation Theories
C 2 − C1 C1
The formula contains two factors, K and R0, where K = , and R0 = R1 − .
R2 − R1 K
The calibration math model requires two calibrators. C1 and C2 are the concentrations of
calibrator 1 and 2; R1 and R2 are the responses of calibrator 1 and 2;
Calculation formula:
C = K × (R −R 0 )
The formula contains two factors, K and R0. The calibration math model requires n(n≥3)
calibrators. Ci is the concentration of calibrator i. Ri is the response of calibrator i. K and R0
can be calculated with the least square method:
n n n
∑ Ri
i =1
2
− (∑ Ri) 2 / n
i =1
n
(∑ Ci ) / n
R0 = (∑ Ri ) / n − i =1
i =1 K
Logit–Log 5P
1
R = R0 + K
Calculation formula: 1 + exp[−(a + b ln C + cC )]
The formula contains five factors, which are R0, K, a, b and c. The calibration math model
requires at least five calibrators, and calculates the five factors with the L-M method.
This math model has the same application with the Logit-Log 4P except for a higher fitting.
4-11
4 Operation Theories
Exponential 5P
Calculation formula:
R = R0 + K exp[a ln C + b(ln C ) 2 + c(ln C ) 3 ]
The formula contains five factors, which are R0, K, a, b and c. The calibration math model
requires at least five calibrators, and calculates the five factors with the L-M method.
This calibration type is applied to the chemistries which have a calibration curve with the
response directly proportional to the concentration.
Polynomial 5P
R − R0 R − R0 2 R − R0 3
ln C = a + b( ) + c( ) + d( )
Calculation formula: 100 100 100
The formula contains five factors, which are R0, a, b, c and d. The calibration math model
requires at least five calibrators. The response (R) of the first calibrator (with internal
converting concentration of 0) is R0, which is given.
R − R0
x=
Suppose, y = ln C and 100 .
Then, y = a + bx + cx + dx
2 3
can be calculated with the least square method for
polynomial expressions.
Parabola
Calculation formula:
R = aC 2 + bC + R0
The formula contains three factors, which are a, b and R0. The calibration math model
requires at least three calibrators. The three factors can be calculated with the least square
method.
Spline
Calculation formula:
R = R0i + ai (C − C i ) + bi (C − C i ) 2 + ci (C − C i ) 3
The calibration math model requires 2-9 calibrators. Suppose the number of calibrators is n,
R a b c
then the calculation formula contains 4(n-1) factors, which are 0i , i , i , and i . Due to
the subsection fitting, this math model has be best fit curves than other math models.
4-12
4 Operation Theories
4.7.1 Introduction
Figure 4.5 Reaction curve of antigen and antibody
Prozone Equivalent Postzone
Response R
Concentration C
In the reaction of antigen and antibody, the amount of generated insoluble compound is
closely related to the proportion of antigen and antibody. The maximum amount of compound
will be generated at a proper proportion of antigen and antibody, at this point least light is
passed and the greatest absorbance is obtained. For other proportions, the amount of insoluble
compound will decrease with more light passed and lower absorbance calculated. Therefore,
samples with quite different concentrations may generate the equivalent amount of insoluble
antigen/antibody compound, and can have the same test results without a Prozone check. The
Prozone check, therefore, is necessary for antigen-antibody reactions.
The Prozone limit is the allowable maximum or minimum PC when antigen excess does not
happen.
The Prozone check factors include:
• PCM (Prozone check limit), q1, q2, q3 and q4.
• Absorbance low limit: ABS
The Prozone check can be performed in two ways: rate check and antigen addition, which are
described in detail in the following sections.
4-13
4 Operation Theories
increased and reaction time extended (antibody excess). If the antibody keeps excess in
specified period, it will continue to react with further added antigen, and the reaction will
increase accordingly. If the antigen is excessive before further addition, the reaction will
decrease. The antigen addition method is applicable to both single-/double-reagent
chemistries.
Enter the Prozone check factors as follows:
• PCM (Prozone check limit), q1 and q2.
• If the absorbance low limit ABS appears in grey, that is q3=q4=0, it cannot be set up.
• 68≥q2≥40>q1≥Reaction end point.
If one of PCM, q1 and q2 is not input, the system will not check the antigen.
• Sample PC=Aq2-k×Aq1.
− k is the calculation factor.
− For single-reagent chemistries: k=(VR1+VS)/(VR1+2VS).
− For double-reagent chemistries: k=(VR1+VS+VR2)/(VR1+2VS+VR2).
The system will flag the test result with “PRO” (Prozone check abnormal) and give an alarm
if PC<PCM in positive reactions or PC>PCM in negative reactions.
4-14
4 Operation Theories
• (Reaction end point absorbance – Reaction start point absorbance) < ABS
• The sample response is not within the calibrator response range for sample and control
analysis of non-linear chemistries.
4-15
4 Operation Theories
4-16
BS-800 Chemistry Analyzer
Operator’s Manual
Advanced Volume
Contents
I
Contents – Advanced Volume
II
Contents – Advanced Volume
III
Contents – Advanced Volume
IV
Contents – Advanced Volume
V
Contents – Advanced Volume
Contents ·································································································I
5 Reagents··························································································· 5-1
5.1 Overview .............................................................................................................................................. 5-1
5.1.1 Introduction............................................................................................................................ 5-1
5.1.2 Reagent/Calibration Screen Overview................................................................................... 5-1
5.2 Sort Reagents........................................................................................................................................ 5-4
5.2.1 Introduction............................................................................................................................ 5-4
5.2.2 Sort Reagents ......................................................................................................................... 5-4
5.3 Reagent Inventory Alarm Limits Setup ................................................................................................ 5-4
5.3.1 Introduction............................................................................................................................ 5-4
5.3.2 Setting up Reagent Inventory Alarm Limits .......................................................................... 5-5
5.4 Reagent Inventory Check ..................................................................................................................... 5-6
5.4.1 Introduction............................................................................................................................ 5-6
5.4.2 Checking Reagent Inventory ................................................................................................. 5-6
5.5 Reagent Set ........................................................................................................................................... 5-7
5.5.1 Introduction............................................................................................................................ 5-7
5.5.2 Define/Remove Reagent Set Window Overview................................................................... 5-7
5.5.3 Defining a Reagent Set .......................................................................................................... 5-8
5.5.4 Removing a Reagent Set........................................................................................................ 5-9
5.6 Bar-Coded Reagents Load .................................................................................................................... 5-9
5.6.1 Loading Bar-Coded Reagents ................................................................................................ 5-9
5.7 On-line Load of Reagents ................................................................................................................... 5-10
5.7.1 Introduction.......................................................................................................................... 5-10
5.7.2 On-Line Load of Reagents................................................................................................... 5-10
5.8 Off-line Load of Reagents .................................................................................................................. 5-11
5.8.1 Introduction.......................................................................................................................... 5-11
5.8.2 Off-line Load of Reagents ................................................................................................... 5-12
5.9 On-Line Replacement of Reagents ..................................................................................................... 5-13
5.9.1 Introduction.......................................................................................................................... 5-13
5.9.2 On-Line Replacement of Reagents ...................................................................................... 5-13
5.10 Off-Line Replacement of Reagents .................................................................................................. 5-14
5.10.1 Introduction........................................................................................................................ 5-14
5.10.2 Off-Line Replacement of Reagents.................................................................................... 5-14
5.11 Unloading Reagents.......................................................................................................................... 5-14
5.11.1 Introduction........................................................................................................................ 5-14
VI
Contents – Advanced Volume
VII
Contents – Advanced Volume
VIII
Contents – Advanced Volume
IX
Contents – Advanced Volume
X
Contents – Advanced Volume
XI
Contents – Advanced Volume
XII
Contents – Advanced Volume
XIII
Contents – Advanced Volume
XIV
Contents – Advanced Volume
XV
Contents – Advanced Volume
XVI
Contents – Advanced Volume
XVII
Contents – Advanced Volume
XVIII
5 Reagents
5.1 Overview
5.1.1 Introduction
This chapter introduces the advanced application of the reagent module. Perform the
following operations according to the practical conditions in your laboratory:
• Setting up reagent inventory alarm limits
• Checking reagent inventory
• Defining and removing reagent bottle set
• Loading bar-coded reagents
• On-line load of reagents
• Off-line load of reagents
• On-line replacement of reagents
• Off-line replacement of reagents
• Unloading reagents
5-1
5 Reagents
The ISE reagent/calibration screen is divided into three areas. The upper list shows the ISE
chemistries, calibration status, calibration date and calibration time left; the lower list shows
the volume, load date, expiration date, lot number and serial number of all wash solutions and
physiological saline; the function buttons at the bottom are used to access relevant functions.
5-2
5 Reagents
Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
Figure 5.2 Biochemistry reagent/calibration screen
The screen shows all configured biochemistry reagents, including the following information:
• Position: position of the reagent on the reagent carousel.
• Chemistry: name of the chemistry.
• Chemistries left: For open reagents, it refers to the minimum tests left of R1, R2, R3 and
R4; for closed reagents, it refers to the sum of tests left of all reagent bottle sets. The
number of chemistries left varies with the number of tests left. When the number of
chemistries left is 0, the chemistry is still allowed for programming and measurement.
• Reagent type: reagent type of a multi-reagent chemistry. It includes R1, R2, R3 and R4.
• Tests left: For open reagents, it refers to the remaining tests of each reagent bottle; for
closed reagents, it refers to the remaining tests of each reagent bottle in a reagent bottle
set.
• Days left: the difference of reagent expiration date and current date and the uncapping
time, whichever the less. When a negative value is displayed, it indicates that the reagent
is expired and should be replaced immediately.
• Lot number: lot number of the reagent. It can be input manually during reagent load.
• Calibration status: calibration status of the chemistry, including, Cal Required, Requested,
Calibrated, Cal Failed, Cal Time Out, Cal Time Extended, Calculated, Edited, Cal
Overridden, Lot Cal and N/A.
• Time left: the time left when the calibration factors are expired. It will be displayed only
when the calibration status is Calibrated, Cal Time Out or Cal Time Extended. When the
5-3
5 Reagents
time left is less than 30 minutes, the system displays a message indicating calibration
time out; when the calibration time is exceeded, the calibration factors can no longer be
used, and you are allowed to recalibrate the chemistry or extend the calibration time.
5.2.1 Introduction
Reagents on the biochemistry reagent/calibration screen can be sorted by name, position,
chemistries left, days left and calibration time left, and a V-type symbol appears to the right of
the sort criteria. Prior to loading reagents or running calibrations, sort the reagents to display
the desired ones in the front.
1. Select Reagent-Reagent/Calibration.
2. Select the down-arrow button on the right side of the screen to display the biochemical
reagents.
3. Choose a sorting criteria, and then click on the corresponding list head to rearrange the
reagents.
5.3.1 Introduction
When the reagent inventory is lower than the alarm limits during or before the analysis, the
5-4
5 Reagents
system will give an alarm and display the reagent or wash solution name in yellow on the
Reagent/Calibration screen, and the volume of ISE buffer solution and wash solutions
become 0.
2. Type in the allowable number of tests for remaining reagent in the Bio Reagent field.
3. Type in the inventory alarm limit of ISE reagent and wash solutions in the ISE
Rgt/Wash field.
The alarm limit is applicable to the ISE reagent, reagent probe wash solution,
physiological saline and sample probe wash solution. The input range is 5%-50%, and
the default is 15%.
5-5
5 Reagents
5.4.1 Introduction
The system provides the manual and auto check of inventory of biochemical reagents, sample
probe wash solution and reagent probe wash solution. At the first aspiration during a test or
after the reagent is loaded, the system automatically checks the reagent inventory and displays
it on the Reagent/Calibration screen. Prior to the measurement, it is necessary to perform
the inventory check in order to ensure that sufficient reagents are available for analysis.
Reagent inventory check is allowed only when the system status is Incubation or Standby.
1. Select Reagent-Status.
5-6
5 Reagents
• All reagents of selected chemistry: check the inventory of all reagent types of the
selected chemistry.
5. Select Check.
5.5.1 Introduction
The reagent set function allows you to manage all reagents of each closed-reagent chemistry
conveniently. The Reagent Set is a logic combination of all reagent types that are probably
used by a chemistry and contains one bottle for each reagent type.
Reagent set is only applied to closed-reagent chemistries with more than one reagent inject
rather than user-defined chemistries. When the reagents of a multi-reagent chemistry are
loaded, the system combines the reagents of each reagent type and of the same lot number
chronologically. The remaining reagents excluded from the set can be grouped again. Each
chemistry may have more than one reagent set.
5-7
5 Reagents
The list at the top of the window displays all reagent sets of the selected chemistry, including
serial number and lot number. The reagents in each line constitute a set. If all reagent sets
cannot be displayed on the current page, move the scroll bar to view more bottle sets.
The list at the bottom of the window displays all single reagents not contained in any reagent
set. You are allowed to group them manually except for the reagents with inventory of 0.
Move the scroll bar on the right of the list to view more reagents.
All single reagents of the chemistry are displayed in the lower list.
5-8
5 Reagents
NOTE
When defining a reagent set, make sure that all reagent types are included with one bottle
for each reagent type, and all reagents in the reagent set are of the same lot.
3. Select Add.
The selected reagents constitute a new set, which is shown in the upper list. The reagent
list refreshes automatically with the reagents constituting the reagent set removed.
4. Select Close.
3. Select Remove.
The selected reagent set is cleared and the reagents contained in it are displayed in the
reagent list at the bottom of the window.
4. Select Close.
5-9
5 Reagents
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation may
be caused.
5.7.1 Introduction
The on-line load of reagents is performed while the system is running tests. Before starting an
on-line load, request for reagent stop, do not load reagents until all started tests are finished
for reagent dispensing. If the system is running calibrations, STAT samples or diluted samples,
you are not allowed to start loading reagents unless all tests finish reagents dispensing.
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation may
be caused.
1. Select Reagent-Reagent/Calibration.
The system status area shows a countdown for reagent stop, and a message box will be
displayed when the countdown is finished.
5-10
5 Reagents
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise, the
tests currently run will be invalidated.
3. To load non-bar-coded reagents, select OK and then Load F1, and remove the reagent
carousel cover; to load bar-coded reagents, just remove the reagent carousel cover.
• Place R1 and R3 in positions 1-68 of the outer ring, and then place R2 and R4 in
positions 1-49 of the inner ring.
• Place reagent probe wash 1 in position D1 (No.70) of the outer ring and reagent
probe wash 2 in position D2 (No.50) of the inner ring.
• Place the physiological saline in position W1 (No.69) of the outer ring of the reagent
carousel.
• Place the ISE wash solution in position D4 (No.139) of the inner sample carousel.
NOTE
While loading reagents, press the load buttons near the reagent carousel to rotate the
outer ring and inner ring for convenient loading. When the reagent load button is pressed,
the corresponding ring will rotate counterclockwise for 1/4 circle.
To load concentrated wash solution, place it in the front cabinet of the analyzing unit
when the countdown for reagent stop becomes 0.
Sample probe wash solution cannot be loaded online.
5.8.1 Introduction
The off-line load of reagents is performed while the system is not running any tests. You are
allowed to directly place the reagents on the reagent carousel, sample carousel or other
positions.
5-11
5 Reagents
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation may
be caused.
• Place R1 and R3 in positions 1-68 of the outer ring, and then place R2 and R4 in
positions 1-49 of the inner ring.
• Place the sample probe wash in position D3 on upper left corner of the sample
carousel.
• Place reagent probe wash 1 in position D1 (No.70) of the outer ring and reagent
probe wash 2 in position D2 (No.50) of the inner ring.
• Place the physiological saline in position W1 (No.69) of the outer ring of the reagent
carousel.
• Place the ISE wash solution in position D4 (No.139) of the inner sample carousel.
NOTE
While loading reagents, press the load buttons near the reagent carousel to rotate the
outer ring and inner ring for convenient loading. When the reagent load button is pressed,
the corresponding ring will rotate counterclockwise for 1/4 circle.
5-12
5 Reagents
5.9.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is running
tests, you should request for reagent stop and replace the reagent immediately to ensure that
the following measurements will be done smoothly.
1. Select Reagent-Reagent/Calibration.
The system status area shows a countdown for reagent stop, and a message box will be
displayed when the countdown is finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise, the
tests currently run will be invalidated.
4. To load non-bar-coded reagents, select OK and then Load F1, and remove the reagent
carousel cover; to load bar-coded reagents, just remove the reagent carousel cover.
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
5-13
5 Reagents
• For load of bar-coded reagents, the system scans all reagent positions automatically
and read reagent information from the bar code.
5.10.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is not
running any tests, you should replace the reagent immediately to ensure that the following
measurements will be done smoothly.
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
5.11.1 Introduction
If some chemistries will not be used, you are allowed to clear the chemistry parameters and
unload the relevant reagents. The Unload option is also used to remove reagents that are going
5-14
5 Reagents
to be exchanged. All reagents other than ISE buffer solution and concentrated wash solution
can be removed through the Unload function. When a chemistry is requested for quality
control, sample analysis or calibration, all reagents of the chemistry still can be unloaded.
When a reagent is unloaded, all relevant information and its position are cleared. The reagents
that are being used for analysis cannot be unloaded.
1. Make sure that the reagent to be unloaded is not being used for analysis.
2. Select Reagent-Reagent/Calibration.
3. Select the up and down arrow buttons to display the biochemical regent/calibration
screen.
2. Select Reagent-Reagent/Calibration.
3. Select reagent probe wash solution and physiological saline you want to remove.
5-15
5 Reagents
7. Take out the reagent probe wash solution or physiological saline from the reagent
carousel.
2. Remove the sample probe wash solution from position D3 (upper left corner of the
5-16
6 Calibration
6.1 Overview
In a calibration, the system measures the response of the calibrator with given concentration,
and then calculates the factors in the concentration-response equation. In this way, a math
equation about concentration and response is determined. The concentration of a patient
sample can be calculated based on the math equation and the measured sample response.
When the calibration status is abnormal, the system will give an alarm and display the
calibration status with specific color. The system allows multiple concentrations of a
calibrator for multi-point calibration. The calibration factors can be adjusted through a reagent
blank test. When you set up the auto calibration conditions, the system will automatically
remind you of calibrating chemistries. Expired calibration factors can be used again by
extending the calibration time. You are allowed to override a failed calibration and obtain
results based on the failed calibration factors.
6-1
6 Calibration
6-2
6 Calibration
6.3.1 Introduction
The system supports diluted calibrator(s) and allows one calibrator to have 9 concentrations
for the same chemistry. You are only required to enter the final concentration of the diluted
calibrator and the diluted calibrator volume aspirated by the sample probe during calibration.
The system will automatically calculate the diluent volume and the sample volume for
diluting. When you set up the dilution factors for a chemistry, its original calibrator
concentration will be removed.
Diluted calibrator is only applied to biochemical chemistries rather than ISE chemistries.
You are allowed to edit or delete the calibrator dilution factors when the system is not running
any tests.
1. Select Reagent-Reagent/Calibration.
6-3
6 Calibration
7. Enter the final concentration of the diluted calibrator in the Conc field.
8. Enter the calibrator volume dispensed by the sample probe during calibration in the
The input must be an integer multiple of 0.1 within 1.5μl-35μl. This field is required.
9. Enter the calibrator volume used for diluting in the Neat Vol field.
The input must be an integer multiple of 0.1 within 1.5μl-35μl. This field can be left
blank.
10.Enter the diluent volume used for diluting in the Diluent Vol field.
The input must be an integer multiple of 0.5 within 15μl-300μl. This field can be left
blank.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of the two
volumes is within 100μl-360μl.
The two volumes must be defined or left blank simultaneously.
6-4
6 Calibration
11.Select Save.
12.To define more concentrations for the calibrator, repeat step 7 to 11.
13.To set up dilution factors for other calibrators, repeat step 5 to 12.
14.Select Close to exit the window.
1. Select Reagent-Reagent/Calibration.
8. Select Edit.
9. Change the concentration, sample volume, neat sample volume and diluent volume.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of the two
volumes is within 100μl-360μl.
The two volumes must be defined or left blank simultaneously.
10.Select Save.
11.Select Close to exit the window.
6-5
6 Calibration
1. Select Reagent-Reagent/Calibration.
8. Select Delete.
6.4.1 Introduction
In a reagent blank test, the reagents react with the physiological saline or a calibrator with
concentration of 0, and then the blank absorbance is calculated. When a reagent is uncapped
for a long period, the reagent absorbance may be changed. At this time, you are allowed to run
a reagent blank instead of calibration to calculate the reagent blank absorbance, which will be
used to adjust the calibration factors of the reagent in order to ensure reliable sample results.
The reagent blank is allowed only in the following calibration status:
• Calibrated
• Cal Time Out
If the reagent blank results, including the mixed blank absorbance and blank response, are
within the acceptance range, the system will update the calibration factors and the remaining
calibration time based on the results. If the results exceed the acceptant limits, the system will
give an alarm and remind you to rerun the reagent blank. The Biochemistry Calibration
screen shows the calculated reagent blank response, absorbance and run date.
Reagent blank is applied to biochemical chemistries only.
6-6
6 Calibration
1. Select Utility-Chemistries.
2. Choose a biochemical chemistry, or enter the chemistry name in the Chemistry Name
field.
4. Select the down-arrow button to show the error detection parameters setup page.
5. Enter the mixed blank absorbance range in the Mixed Blank Abs field.
Both the low and high limits must be an integer within -34,000-34,000. The default is
blank, which means not performing this check.
Both the low and high limits must be an integer within -34,000-34,000. The default is
blank, which means not performing this check.
1. Select Reagent-Reagent/Calibration.
6-7
6 Calibration
4. Enter the calibration factor validity period in the Rgt Blank field.
The input range must be within 1-9999 hours. The default is blank, which means the
reagent blank calibration factors of the chemistry can be used without time limit.
2. Check if the desired chemistries’ calibration status is Calibrated, Cal Time Out or Cal
Required.
6. Select OK.
6-8
6 Calibration
The calibration results and reagent blank results of the chemistry are displayed in the
result list.
The response value current displayed is the updated reagent blank response.
6. Select the reaction data table to view the reagent blank reaction data.
6-9
6 Calibration
• Prev F4: to view reaction curve and data of the previous calibrator of the chemistry.
• Next F5: to view reaction curve and data of the next calibrator of the chemistry.
• Print F7: to print the current reaction curve or data.
The calibration results and reagent blank results of the chemistry are displayed in the
result list.
6-10
6 Calibration
The graphical trend of the selected chemistry within the specific period is displayed.
6-11
6 Calibration
6.5.1 Introduction
Based on the auto calibration conditions, the system can determine chemistries that need to be
calibrated and remind you through calibration status and color indication. Auto calibration
conditions include:
• Calibration factors’ validity period
• Reagent lot changed
• Reagent bottle changed
For closed chemistries, calibration will be run automatically when reagent lot number is
changed. If you desire to run calibration when reagent bottle is changed, each reagent set
needs to be calibrated to obtain calibration factors; if calibration based on reagent bottle
change is not enabled, a chemistry with reagent sets of the same lot number will be run and
6-12
6 Calibration
calculated with calibration factors of the previous reagent set instead of being calibrated.
Chemistries with results calculated based on calibration factors of another reagent set will
calibration status of Calibrated, which is marked with “run”. When the calibration time is
exceeded, the system will remind you of running calibrations.
1. Select Reagent-Reagent/Calibration.
• Bottle changed: The system will remind you to run a calibration when you use a
different bottle of reagents.
• Lot changed: The system will remind you to run a calibration when you use reagents
of a different lot. If the reagents have no lot number, they will be considered as the
same lot and different from other lots.
• Calibration time: The system will remind you in 30 minutes before the calibration is
timed out and display the chemistry’s calibration status with yellow.
6-13
6 Calibration
1. Select Reagent-Reagent/Calibration.
6.6.1 Introduction
Calibration factors that exceed the calibration period cannot be used for result calculation.
6-14
6 Calibration
The calibration status becomes Cal Required and the chemistry can no longer be run. The
system will display a warning message in 30 minutes before the calibration is timed out, and
you are allowed to recalibrate the chemistry or extend its calibration time. If you are certain
that the calibration factors are correct and valid, you may prolong their validity period by
using the calibration time extension function. A calibration time can be extended only if the
current calibration of the chemistry is timed out. The results calculated based on extended
calibration factors will be flagged.
1. Select Reagent-Reagent/Calibration.
2. Select the up and down arrow buttons to display the biochemical reagent/calibration
screen.
6. Select OK. The calibration factors of the selected chemistry can be used without time
limit.
6.7.1 Introduction
The Calibration Override option allows the system to override a failed calibration and
calculate results based on the failed calibration factors. Calibration override is only applied to
failed calibrations. Results that are obtained based on failed calibration factors will be
flagged.
6-15
6 Calibration
CAUTION
Before overriding a calibration, make sure that the calibration factors are within the
acceptance limits of your laboratory. The magnitude of the error should be totally under the
control of your laboratory. Use of overridden calibration factors may lead to unreliable results
and influence the doctor’s diagnosis. Think twice before overriding a failed calibration.
1. Select Reagent-Reagent/Calibration.
4. Select OK. The failed calibration factors of the selected chemistry can be used for result
calculation.
6-16
6 Calibration
The screen shows all the calibrations requested on the day, including the following
information:
• Chemistry name
• Result flag
• Calibration status
• R0: reagent blank response
• K: K factor
• A, B, C and D: factors a, b and c in nonlinear calibration equations
• Run date and time
The current calibration factors of the chemistry are displayed in the result list.
The calibration factors used within the specified period are displayed on the screen.
• Cal Curve F2
• Reac Curve F3
• Edit F4
• Archive F5
• Trend F6
6-17
6 Calibration
• Print F7
6-18
6 Calibration
The corresponding calculation formula is displayed in the text box to the right of the
Math Model field.
7. Choose calibrators to recalculate in the left list. Move the scroll bar to view more
calibrators.
6-19
6 Calibration
Choose the correct number of calibrators corresponding to the math model. For more
information, refer to 3.4.5 Setting up Calibration Rules (page 3-30).
The system will recalculate the calibration factors with the selected math model and
calibrators.
• If the recalculation is succeeded, the new calibration factors will be displayed on the
Biochemistry Calibration screen with the calibration status shown as
Recalculated, and “CALR” will appear in the corresponding Flag column.
• If the recalculation is failed, the system will show a message box indicating the old
calibration factors will remain to be used.
9. To view the reaction curve of the selected calibrator, select Reac Curve F1.
6-20
6 Calibration
• Sample Blank F2: to view the sample blank reaction curve and reaction data of the
calibrator.
• Prev F4: to view reaction curve and data of the previous calibrator of the chemistry.
6-21
6 Calibration
• Next F5: to view reaction curve and data of the next calibrator of the chemistry.
• Print F7: to print the current reaction curve or data.
6. Select Save.
The system will refresh the calibration results and curves with the input slope and offset,
and take the edited calibration factors as the defaults.
6-22
6 Calibration
5. Select Save.
6-23
6 Calibration
6-24
6 Calibration
• Prev F4: to view the calibration trends and data of the previous chemistry.
• Next F5: to view the calibration trends and data of the next chemistry.
• Print F7: to print the current graphic trend or data.
6-25
6 Calibration
6-26
7 Quality Control
7.1 Overview
7.1.1 Introduction
A QC run may require more than one control samples. You are recommended to use two
control samples, one with normal values (within the reference range) and the other with
abnormal values (beyond the reference range).
To ensure the system performance, run control samples every time after you perform a
calibration, or change the reagent lot, or maintain and troubleshoot the instrument.
Program Running
Load control Recall QC Print real-time
control control
Daily operations samples results QC results
samples samples
7.1.3 QC Alarms
The system provides the real-time monitoring of quality controls, and check if the QC results
are under control when a QC run is finished. If the results exceed the reference range, the
system will give an audible alarm and shows an alarm message indicating the chemistry name,
7-1
7 Quality Control
control name and control rules. For instance, “Chemistry ALT control C1 13s out of control!”.
In this situation, you should stop the analysis and find the causes of the failure, and resume
the analysis after solving the problem.
For QC alarms and corrective actions, refer to 17.6 Error Messages and Corrective Actions
(page 17-20).
7-2
7 Quality Control
7.2 QC Evaluation
7.2.1 Introduction
The system provides the Westgard rules for evaluating QC results of the chemistries, and give
alarms and flags when the obtained QC results are beyond the reference range. Since every
chemistry may have one or more control samples, the QC results can be evaluated with
different rules accordingly. Those controls that are not included in any lots will be evaluated
as single controls.
7-3
7 Quality Control
No
>2S In-control
Yes No
Yes
12S Warning
No
No No No
13S 22S 41S 10X
Ye
Yes Yes Yes
s
Out of control
3. Choose 9 QC Evaluation.
5. Select OK.
Two-control evaluation rules
In every QC run, two results are obtained: Xn and Yn, which are used to define a point on the
Twin-plot chart. In this way, a complete twin-plot chart is drawn based on all the QC results
and used for detecting systematic errors and random errors.
7-4
7 Quality Control
The Westgard rules for two-control evaluation are listed in the table below:
7-5
7 Quality Control
Measured values of X
and Y controls
No
12S In control
Yes
No
No No No
22SA R4S 41SA 10XA
Yes Yes Yes Yes
7.3.1 Introduction
The system provides the auto quality control function. When the conditions for a QC run are
satisfied and the Auto QC checkbox on the Start Conditions window is selected, the system
will request and run the specified controls automatically. The control samples automatically
run can be selected on the QC Parameters window.
The conditions for auto quality control include:
• Number of samples: indicates the number of patient samples. After the given number of
samples is finished, the system will run the selected control(s) automatically.
• When calibrated: The system will automatically run the chemistry for the selected
control(s) every time when the chemistry is calibrated. Auto QC is not applicable to
non-measurement calibrations, such as recalculation, editing and lot calibration.
When the control samples automatically run are selected, all chemistries configured for the
control samples will be run.
3. Choose 9 QC Evaluation.
7-6
7 Quality Control
• Number of Samples: enter the number of samples for auto QC run. The input
range is 10-500, 0 means auto QC is disabled.
• When Calibrated: select the checkbox to allow the system to run controls when a
chemistry is calibrated.
6. Select OK.
2. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
4. Select OK. The system will insert a QC run in the current test queue.
7-7
7 Quality Control
• The Current Results screen displays all incomplete patient samples and control
samples, as well as those programmed on the current day.
• The History Results screen displays all patient samples and control samples
programmed before the current day.
7-8
7 Quality Control
7-9
7 Quality Control
• Sample Blank F2: to view the sample blank reaction curve and reaction data of the
selected control.
• Prev F4: to view the reaction curve and data of the previous chemistry.
• Next F5: to view the reaction curve and data of the next chemistry.
• Print F7: to print the current reaction curve or data.
1. Search for desired control results on the Current Results or History Results screen.
7-10
7 Quality Control
• Selected Sample(s)
• All Sample(s)
5. If you print all samples, you are allowed to skip those that are already printed out. Mark
6. Select OK.
1. Select QC-Levey-Jennings.
6. Select Search F1. The L-J chart area shows the QC result trends of the selected
7-11
7 Quality Control
1. Select QC-Twin-Plot.
4. Select Search F1. The twin-plot chart area displays the recent 10 results of control X
7-12
7 Quality Control
1. Select QC-Results.
7-13
7 Quality Control
The result list shows all results of the control for the chemistry during the specified
period, as well as the set means and standard deviations.
Figure 7.9 Results screen
Sort QC results
The searched QC results can be rearranged by control or chemistry.
7-14
7 Quality Control
4. Select OK.
The QC results on the Results screen are rearranged ascending based on the selected
criterion.
7-15
7 Quality Control
• Sample Blank F2: to view the sample blank reaction curve and reaction data of the
selected control.
• Prev F5: to view the reaction curve and data of the previous control.
7-16
7 Quality Control
• Next F6: to view the reaction curve and data of the next control.
• Print F7: to print the current reaction curve or data.
Add QC comments
Comments can be added to specific QC result for special notice.
5. Select OK.
Archive QC data
The system allows archiving of QC results to a storage device. The file format is CSV and the
default file name is QCData.csv. which cannot be edited. QC results must not be archived to
the hard disk.
The archived QC results and data include the following information:
7-17
7 Quality Control
4. Select OK.
1. Select QC-Summary.
7-18
7 Quality Control
The result summary of the control for the chemistry is displayed on the screen.
Figure 7.15 Summary screen
7-19
7 Quality Control
7-20
8 Sample Programming and Processing
8.1 Overview
Sample programming can be performed in manual and auto modes, in batch or by single, by
rerunning or adding chemistry and samples, in common or quick STAT mode, and via virtual
sample carousels. Chemistries selected for samples include biochemical chemistries, ISE
chemistries, serum index, calculations, and panels. If a chemistry will not be used in your
laboratory, you are allowed to mask it and remove it from the chemistry list. Samples can be
programmed and analyzed based on the running options. Patient demographics should be
entered before or during the measurements. You may view the sample analyzing status
through the Status screen. The system allows the deletion of programmed and complete
samples.
These functions and operations will be described in detail in the following sections.
8.2.1 Introduction
Except for analysis of routine samples, you often need to add samples or chemistries to the
programming or rerun an abnormal sample. Samples can be diluted manually or prediluted
automatically before being analyzed.
8-1
8 Sample Programming and Processing
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
3. Select the icon on the upper-right corner of the main screen to request for sample
stop.
4. Check the sample stop countdown in the system status area and wait until it comes to 0.
5. Check the sample carousel indicators, and proceed to the next step when the indicators
are extinguished.
6. Place the added samples on the assigned positions of the sample carousel.
• If the system is running tests, it will analyze the added samples automatically.
• If the system is not running any tests,
8-2
8 Sample Programming and Processing
1. Select Program-Sample.
3. Deselect chemistries you won’t run, and then select chemistries you desire to run.
4. Deselect panels you won’t run, and then select panels you desire to run.
• If the system is running tests, it will analyze the added chemistries and panels
automatically.
• If the system is in Standby status, select the icon on the upper-right corner of
the main screen.
8-3
8 Sample Programming and Processing
1. Select Program-Sample.
8-4
8 Sample Programming and Processing
1. Select Program-Sample.
Separate single samples with comma, e.g. 5, 7, 9; and connect multiple continuous
samples with a dash, e.g. 1-3.
8-5
8 Sample Programming and Processing
9. Select Batch.
8-6
8 Sample Programming and Processing
11.Select OK.
8-7
8 Sample Programming and Processing
The sample volume is the same as that defined for the chemistry. If increased and
decreased volumes are defined for the chemistry, Increased and Decreased are available
here for selection.
The input range must be within 4-201. The default is blank, which indicates that the
sample needs not to be prediluted before being analyzed.
9. Select OK.
1. Select Utility-Chemistries.
8-8
8 Sample Programming and Processing
The system will rerun the sample if the chemistry result is beyond the critical range.
1. Select Utility-Chemistries.
2. Choose a chemistry.
4. Select the down-arrow button to show the error detection parameters setup page.
The linearity range indicates the measurable range of the system, during which the test
result is linear to the response R. The system compares the calculated sample
concentration with the linearity range. When the high limit is exceeded, the > sign will
appear near the result; when the low limit is exceeded, the < sign will appear.
The system will rerun the sample if the chemistry result is beyond the linearity range.
8-9
8 Sample Programming and Processing
1. Select Utility-Chemistries.
2. Choose a chemistry.
5. Enter the dilution factor for auto rerun test in the For Auto Rerun field.
The input range can be any integer within 4-201. When the dilution factors for both
normal run and rerun are defined, the product between the two factors and the
predilution factor must not be greater than 201.
6. Select Save.
The system will dilute the sample with the factor and rerun it if the chemistry result is
beyond the critical or linearity range.
7. Select Close.
8-10
8 Sample Programming and Processing
5. Select Recall Rerun Results. The Recall Rerun Results window is displayed.
The screen shows the sample information and all reruns results of the chemistry.
Figure 8.8 Recall Rerun Results window
6. The latest rerun result is the default one. To change the default result, choose a result,
The Default column of the result shows Y, which stands for Yes.
8-11
8 Sample Programming and Processing
the processing of samples with increased or decreased volume. When a sample is analyzed
with standard volume and a result is beyond the reference range or deemed abnormal, you are
allowed to rerun the corresponding chemistry manually with the increase or decreased sample
volume.
1. Select Utility-Chemistries.
2. Choose a chemistry.
It ranges from 1.5μl to 35μl with an increment of 0.1μl. The default is 1.5μl. A maximum
of one decimal is allowed.
It ranges from 1.5μl to 35μl with an increment of 0.1μl. The default is blank. A
maximum of one decimal is allowed.
It ranges from 1.5μl to 35μl with an increment of 0.1μl. The default is blank. A
maximum of one decimal is allowed.
8-12
8 Sample Programming and Processing
9. Select Program-Sample.
8-13
8 Sample Programming and Processing
If the sample volume, replicates and predilution factor are set for both the sample and the
chemistry, the chemistry will be run based on its own settings instead of those of the sample.
1. Select Utility-Chemistries.
2. Choose a chemistry.
5. Enter the dilution factor for normal test in the For Normal Run field.
6. Select Save.
7. Select Close.
8. Select Program-Sample.
• ID
• Sample position
8-14
8 Sample Programming and Processing
• STAT status
• Sample type
• Comment
• Chemistries and panels
12.Select a sample tube type from the Sample Cup pull-down list.
The options include:
• Microtube
• Standard
8-15
8 Sample Programming and Processing
16.Choose a chemistry.
17.Select a sample volume type in the Sample Vol column for the chemistry.
18.Enter the number of replicates.
19.Enter the predilution factor.
When dilution factors for both normal run and rerun are defined, the product between the
two factors and the predilution factor must not be greater than 201.
2. Choose a chemistry.
8-16
8 Sample Programming and Processing
The system will run a sample blank when running calibrators, controls and samples for
the chemistry.
8-17
8 Sample Programming and Processing
Sample volume
The amount of sample required for a common measurement is 1.5-35μl, with an increment of
0.1μl. Analysis with insufficient samples may lead to inaccurate results.
If a sample is exhausted during the analysis, the system will automatically invalidate all
incomplete chemistry of the sample. Before running samples, make sure that they are
8-18
8 Sample Programming and Processing
Loading samples
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Caution
When loading Φ16.5×92mm sample cups, remove the sample carousel, or press the sample
carousel with one hand and load the sample cups with the other hand.
1. Check if the sample inside the sample tube is sufficient for analysis and the bar code
3. Check if the sample carousel and the sample probe have stopped moving.
5. Insert the sample tube into the tube holder until the tube bottom contacts the groove of
6. To load more samples, press the sample load buttons. The sample carousel rotates
Unloading samples
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
8-19
8 Sample Programming and Processing
Caution
When unloading Φ16.5×92mm sample cups, remove the sample carousel, or press the sample
carousel with one hand and take out the sample cups with the other hand.
1. Check if the sample carousel and the sample probe have stopped moving.
4. Grab the sample tube and pull it upward to remove it from the tube holder.
5. To unload more samples, press the sample load buttons. The sample carousel rotates
8.3.1 Introduction
Serum index is the degree of hemolysis, icterus and lipemia contained in serum sample. There
are usually seen in serums and can influence the test results in physical or chemical way.
The serum index function is used to analyze the interferents in samples, helping clinical
professionals to evaluate the test results.
The obtained serum index can be used to compensate the results or reported on patient reports
in the form of flags.
The system allows the determination of hemolysis, icterus and lipemia and flags the result if
needed.
8-20
8 Sample Programming and Processing
(1)
(2)
(3)
The figure above shows the absorption spectrum of interferents in serum samples. (1) refers to
lipemia, (2) refers to hemolysis, and (3) refers to icterus.
The three interferents are selective to wavelength and have complex absorption spectrums.
They cannot be removed completely by means of double-wavelength measurements. The
serum index option can be used to analyze the interferents contained in samples, helping
clinical professionals to evaluate the test results.
Six wavelengths are chosen to determine the serum index. The equations of serum index are
as follows:
• Lipemia: primary wavelength of 660, secondary wavelength of 700.
8-21
8 Sample Programming and Processing
4. Type in the print name of lipemia in the Print Name of the Lipemia area. Up to 15
The lipemia index will appear as the print name on patient reports and as “SI” on other
reports.
8-22
8 Sample Programming and Processing
1. Select Utility-Chemistries.
The Range and Flag fields below are activated for editing.
5. Type in the detection range in the first edit box of the Range field, and then enter a flag
For instance, type in “10” in the first edit box of the Range field in the Lipemia area,
and then enter “+” in the Flag field of the same row. If the lipemia volume (L1)
contained in a sample is lower than 10, the “+” sign will be added to the result in the
patient report. Type in “20” in the second edit box below the Range icon and “+-” in the
second edit box below the Flag icon. If the lipemia volume (L2) is greater than 10 and
lower than 20, the result will be flagged with the “+-” sign. The cycle continues. If the
result is greater than L5, the six flag will appear on the patient report.
6. Repeat step 4-5 to define ranges and flags for hemolysis and icterus.
8-23
8 Sample Programming and Processing
8.4.1 Introduction
The Clear Samples function is used to delete programmed samples that have not been
analyzed. One or more samples can be cleared at one time. When samples are cleared, the
sample information will be removed completely; the sample ID, position and bar code can be
used for programming other samples. The action of clearing samples will be recorded in the
edit logs.
1. Select Program-Sample.
8-24
8 Sample Programming and Processing
4. Select OK.
The selected samples are cleared along with their programming information.
8.5.1 Introduction
Unpositioned samples are those:
• downloaded from the LIS host and not positioned yet. Such samples cannot be
programmed for analysis until they have positions assigned. If your system is equipped
with a sample bar code reader, the samples can be analyzed immediately without
assigning positions for them.
• that are in Incomplete status when their positions are used for programming new
samples.
• that are incomplete when their positions are released.
Once positioned, the samples will be removed from the unpositioned samples list.
1. Select Program-Sample.
8-25
8 Sample Programming and Processing
1. Select Program-Sample.
4. Select Assign.
8-26
8 Sample Programming and Processing
The options include all available positions of the selected sample carousel.
• To assign position for single sample, input the position number in the first edit box.
• To assign positions for multiple samples, enter the start position number in the first
edit box, and then the end position number in the second edit box. The system will
assign positions for the samples ascending according to the sample ID.
• If the available positions among the specified range are more than or equal to the
number of samples, the extra positions will be neglected.
• If the available positions among the specified range are less than the number of
samples, the system will display a message indicating insufficient positions. Assign
the positions again.
9. Select OK.
10.To run the samples, select the icon on the upper-right corner of the main screen.
8-27
8 Sample Programming and Processing
8.6.1 Introduction
When a sample is analyzed, the position cannot be used for programming new sample until it
is released. The Status screen provides the Release Sample Position function, which allows
you to release the selected position or all positions on the current sample carousel that are not
running any tests. When a sample is released, its results and programming information can be
still recalled.
Sample positions can be released automatically at specified time everyday. When the set time
is reached,
• If the system is shut down, the sample positions in the status of Complete will be
released next time when the system is started up.
• If the system is not running any tests, the sample positions in the status of Complete will
be released.
• If the system status is Running, the sample positions in the status of Complete will be
released when the system status becomes Standby or Failure at the first time.
When a sample is released, its results and programming information can be still recalled.
1. Select Program-Status.
8-28
8 Sample Programming and Processing
5. Select OK.
4. Type in the auto release time of patient samples in the Auto Release Time field.
5. Select OK.
When the time is reached, the system will release automatically all sample positions in
the status of Complete.
8.7.1 Introduction
The Sample Logs screen provides the controls and patient samples that are not complete
within the recent 24 hours due to certain reasons. You are to rerun the samples or take other
actions for the controls and samples. The sample logs refresh automatically as the analysis is
performed, and can be printed out for archiving.
1. Select Program-Status.
8-29
8 Sample Programming and Processing
3. The screen shows the controls and patient samples that are not complete within the
The table below summaries the sample status and relevant descriptions.
8-30
8 Sample Programming and Processing
Removed The sample has been unloaded but Samples that are being
some tests are still being analyzed are unloaded.
processed.
Duplicate The sample bar code has been The positions for control and
assigned to a sample that already calibrator are occupied by
exists. patient samples.
A sample is detected in an idle
position but has no
corresponding programming
information or default panel.
8.8.1 Introduction
When programming samples, it is necessary to add comments to some special samples, such
as, ** sample has hemolysis; ** sample needs to be analyzed immediately, etc. Sample
comment can be entered manually or selected from the Comment pull-down list on the
Sample screen On the System Setup screen, you are allowed to define up to 20 sample
comments and delete those that are no longed needed.
Sample comments can be defined, edited or deleted in any system status and for samples of
any status.
8-31
8 Sample Programming and Processing
5. Select OK.
8-32
8 Sample Programming and Processing
5. Select OK.
8.9.1 Introduction
The List option allows you to view, inquire and print all unfinished samples, and assign
positions for unpositioned samples. You are also allowed to view the requested chemistries’
calibration status, reagent status, tests left, and number of requests.
1. Select Program-Sample.
8-33
8 Sample Programming and Processing
8-34
8 Sample Programming and Processing
3. Select OK. All samples that satisfy the conditions are displayed on the screen.
1. Select Program-Sample.
8-35
8 Sample Programming and Processing
The screen shows all requested chemistries, including the name, calibration status,
number of requests, and tests left.
8.10.1 Introduction
The Results Recall option allows routine samples, STAT samples and controls to be recalled
and handled on the Current Results or History Results screen. The Current Results
include those that are programmed and analyzed on the current day; the History Results are
those programmed and analyzed before the current day.
8-36
8 Sample Programming and Processing
The screen shows all samples and controls that are programmed and analyzed on the
current day.
Figure 8.25 Current Results screen
The sample type includes N, E and C. N stands for routine sample, E for STAT sample,
and C for control.
The Host column indicates the transmission status of the sample. Y means that the
sample has been sent to the LIS host, and N means the opposite.
2. Choose a sample in the left list. The right list displays all results of the sample.
8-37
8 Sample Programming and Processing
The options include Normal (N), Emergency (E) and Control (C).
4. Select OK. The samples matching the condition are displayed on the screen.
8-38
8 Sample Programming and Processing
• The name can be composed of a-z and A-Z and not case sensitive. Up to 40 letters
can be entered.
• Fuzzy inquiry is allowed by entering partial or all letters of a patient name. The
samples with patient names containing the specified letters will be displayed on the
screen.
4. Select OK. The samples matching the condition are displayed on the screen.
4. Select OK. The samples matching the condition are displayed on the screen.
entered.
Separate single samples with comma, e.g. 1, 3, 5; and connect multiple continuous
samples with a dash, e.g. 1-3, 10, 15-20.
4. Select OK. The samples matching the condition are displayed on the screen.
8-39
8 Sample Programming and Processing
4. Select OK. The sample with the bar code is displayed on the screen.
2. Choose a sample in the sample list. Move the scroll bar to view more samples.
8-40
8 Sample Programming and Processing
• Patient ID
• Patient name
• Date of birth
• Gender
• Comments
• Age
• Ordering department and physician
• Collection date and time
• Ordering date and time
• Clinical diagnosis
• Reviewer
• Tester
8-41
8 Sample Programming and Processing
8-42
8 Sample Programming and Processing
• Sample Blank F2: to view the sample blank reaction curve and reaction data of the
selected sample.
• Prev F4: to view the reaction curve and data of the previous chemistry.
• Next F5: to view the reaction curve and data of the next chemistry.
• Print F7: to print the current reaction curve or data.
8-43
8 Sample Programming and Processing
• QC results
1. Search for desired samples on the Current Results screen.
• Selected sample(s)
• All samples
5. If you transmit all samples, you are allowed to skip those that are already transmitted to
6. Select OK.
8-44
8 Sample Programming and Processing
• Selected Sample(s)
• All Sample(s)
5. If you print all samples, you are allowed to skip those that are already printed out. Mark
6. Select OK.
8-45
8 Sample Programming and Processing
The sample type includes N, E and C. N stands for routine sample, E for STAT sample,
and C for control.
The Host column indicates the transmission status of the sample. Y means that the
sample has been sent to the LIS host, and N means the opposite.
3. Choose a sample in the left list. The right list displays all results of the sample.
8-46
8 Sample Programming and Processing
3. Select the program date range you want to recall. Select the start date in the first box and
The options include Normal (N), Emergency (E) and Control (C).
5. Select OK. The samples matching the condition are displayed on the screen.
8-47
8 Sample Programming and Processing
3. Select the program date range you want to recall. Select the start date in the first box and
− The name can be composed of a-z and A-Z and not case sensitive. Up to 40 letters
can be entered.
− Fuzzy inquiry is allowed by entering partial or all letters of a patient name. The
samples with patient names containing the specified letters will be displayed on the
screen.
5. Select OK. The samples matching the condition are displayed on the screen.
3. Select the program date range you want to recall. Select the start date in the first box and
5. Select OK. The samples matching the condition are displayed on the screen.
8-48
8 Sample Programming and Processing
3. Select the program date range you want to recall. Select the start date in the first box and
entered.
Separate single samples with comma, e.g. 1, 3, 5; and connect multiple continuous
samples with a dash, e.g. 1-3, 10, 15-20.
5. Select OK. The samples matching the condition are displayed on the screen.
3. Select the program date range you want to recall. Select the start date in the first box and
5. Select OK. The sample of the bar code is displayed on the screen.
8-49
8 Sample Programming and Processing
CAUTION
Edit Results function gives doctors with freedom to modify the results, and therefore, must be
used with cautions. Only users that have sufficient permissions are allowed to edit results.
6. Choose a chemistry to edit, and then input result in the Final Result column.
9. Select Cancel.
8-50
8 Sample Programming and Processing
7. Select OK.
8-51
8 Sample Programming and Processing
8-52
9 Result Printouts
9.1 Overview
This chapter describes data archiving, print setup, auto print and manual print methods, and
result printouts.
9.2.1 Introduction
The Data Import and Export function allows various data to be imported from or exported to
an external storage device. Exporting data is allowed only when the system status is Standby,
Incubation and Failure.
The following data can be imported:
• Open-/Closed-reagent chemistries, including biochemistries, ISE chemistries, SI and
calculations
The following data can be exported:
• Sample results (including results of all replicates): transmitted to LIS host
• Control results: transmitted to LIS host
• QC data: archived to external storage device
• Calibration results: archived to external storage device
• Open-reagent chemistries: exported to a .text file
• Event logs: archived to external storage device
9-1
9 Result Printouts
CAUTION
While importing chemistries, do not switch off the analyzing unit main power or exit the
operating software.
1. Select Utility-Chemistries.
3. Select Options.
4. Select Import.
9-2
9 Result Printouts
5. Select Load.
6. Locate the path of the parameter form, and then select it.
7. Select Open.
All chemistries contained in the parameter form are displayed in the Available
Chemistries list.
• Add All>>: add all chemistries in the Available Chemistries list to the Imported
Chemistries list.
• Add ->: add the selected chemistries in the Available Chemistries list to the
Imported Chemistries list.
• <-Remove: remove the selected chemistries from the Imported Chemistries list.
• <<Remove All: remove all chemistries from the Imported Chemistries list.
9. Select Import.
9-3
9 Result Printouts
All imported chemistries with correct parameters are enabled by default and can be used
for measurement. If you change any of the following parameters of an imported
chemistry, recalibrate the chemistry:
• Reaction type
• Primary wavelength
• Secondary wavelength
• Reaction direction
• Reaction time
• Blank time
• Result unit
• Sample volume
• Reagent volume (R1, R2, R3 and R4)
• Sample dilution factors
• Sample blank
10.Select Exit.
Export chemistries
Open-reagent chemistries rather than closed-reagent chemistries can be exported, as well as
the processing parameters, error detection limits, slop and offset, and dilution factors. Only
the open-reagent biochemistries can be exported from the system.
Only users with sufficient permission are allowed to export chemistries. Exporting
chemistries can be performed when the system status is Standby, Incubation and Failure.
1. Select Utility-Chemistries.
3. Select Options.
4. Select Export.
9-4
9 Result Printouts
The Available Chemistries list shows all open-reagent chemistries other than those
that have been masked or disabled.
• Add All>>: add all chemistries in the Available Chemistries list to the Exported
Chemistries list.
• Add ->: add the selected chemistries in the Available Chemistries list to the
Exported Chemistries list.
• <-Remove: remove the selected chemistries from the Exported Chemistries list.
• <<Remove All: remove all chemistries from the Exported Chemistries list.
6. Select Export.
The default file name is composed of the current date and time, such as 20100527_0951.
The file format is .csv.
8. Select Save.
9. Select Exit.
9-5
9 Result Printouts
Archiving QC data
The QC results and data can be archived to a storage device with the file name of QCData.csv,
which cannot be edited.
For more information of archiving QC data, refer to 0Archive QC data (page 7-17).
9-6
9 Result Printouts
9.3.1 Introduction
Results and data can be printed out with the specified template through the default printer.
You are allowed not only to set up the printer type, default printer and printed hospital name,
but also define the print order of chemistries. The specified template is used for patient reports
only.
If your system is equipped with the Data Management Software, you may use it to define or
adjust report templates.
Up to 300 characters can be entered. The hospital name will appear on the header of the
report.
The system supports three types of printer, which include laser printer, inkjet printer and
stylus printer.
8. Select OK.
9-7
9 Result Printouts
9-8
9 Result Printouts
9.4.1 Introduction
Sample reports are used to print sample results, sample list, reaction curve and data, as well as
sample blank reaction curve and data.
The result reports include:
• Single sample report
• Multi-sample report
The list reports include:
• Sample list report
• Control list report
• Chemistry list report
The above-mentioned reports and printing methods are described in detail in the following
sections.
3. Choose a sample.
9-9
9 Result Printouts
6. Select OK.
9-10
9 Result Printouts
1. Select Program-Sample.
3. Select Print F7. All incomplete samples are printed with the specified template.
9-11
9 Result Printouts
1. Select Program-Sample.
All incomplete controls are printed with the specified template. If both patient samples
and controls are shown on the screen, they will be printed out with different templates.
Figure 9.7 Control list report example
1. Select Program-Sample.
9-12
9 Result Printouts
4. Select Print F7. All incomplete chemistries are printed with the specified template.
3. Choose a sample.
9-13
9 Result Printouts
9-14
9 Result Printouts
3. Choose a sample.
9-15
9 Result Printouts
9-16
9 Result Printouts
9.5.1 Introduction
Reagent reports are used to print the list of biochemistries and ISE chemistries, as well as
reagent position, reagent type, tests and chemistries left, calibration status, etc. The reagent
reports include:
• Biochemistry list report
• ISE chemistry list report
9-17
9 Result Printouts
9-18
9 Result Printouts
• Calibration status
• Calibration run date and time
• Calibration time left
• Reagent name
• Volume %
• Load date
• Days left
• Expiration date
• Lot number
• Serial number
1. Select Reagent-Reagent/Calibration.
The screen shows the ISE chemistries and wash solutions of the system.
9.6.1 Introduction
Calibration reports are used to print the calibration results of biochemistries and ISE
chemistries.
9-19
9 Result Printouts
1. Select Reagent-Reagent/Calibration.
9-20
9 Result Printouts
9-21
9 Result Printouts
9-22
9 Result Printouts
9-23
9 Result Printouts
9-24
9 Result Printouts
9-25
9 Result Printouts
9.7 QC Reports
9.7.1 Introduction
QC reports are used to quality control results, such as actual results, L-J chart, twin-plot chart,
QC data and QC summary. They can be printed out on:
• Current Results screen
• History Results screen
• Levey-Jennings screen
• Twin-Plot screen
9-26
9 Result Printouts
• Results screen
• Summary screen
1. Select QC-Levey-Jennings.
9-27
9 Result Printouts
1. Select QC-Twin-Plot.
2. Select Chems F2, choose a chemistry from the list, and then select OK.
9-28
9 Result Printouts
1. Select QC-Results.
9-29
9 Result Printouts
The result list shows all results of the control for the chemistry during the specified
period, as well as the set means and standard deviations.
1. Select QC-Summary.
The result summary of the control for the chemistry is displayed on the screen.
9-30
9 Result Printouts
9.8.1 Introduction
Chemistry reports are used to print sample/control panels and user-defined calculations. They
can be printed out respectively on the Panels and Calculations screens.
1. Select Utility-Chemistries.
All user-defined sample panels and control panels are printed out with the default
templates.
Figure 9.29 Sample panels report example
9-31
9 Result Printouts
1. Select Utility-Chemistries.
All defined calculations are printed out with the default template.
Figure 9.31 Calculations report example
9.9.1 Introduction
The instrument status reports contain the current working status of each subsystem and
hardware component, which includes the status summary, cycle count, temperature, power
supply, Hydropneumatic subsystem, and control modules. They can be printed out on the
Status screen.
9-32
9 Result Printouts
power supply, Hydropneumatic, and control modules. The status includes OK and Error.
1. Select Utility-Status.
1. Select Utility-Status.
9-33
9 Result Printouts
1. Select Utility-Status.
1. Select Utility-Status.
9-34
9 Result Printouts
1. Select Utility-Status.
9-35
9 Result Printouts
1. Select Utility-Status.
1. Select Utility-Maintenance.
9-36
9 Result Printouts
2. Select Maintenance.
5. Select Continue.
7. Select Print.
1. Select Utility-Maintenance.
2. Select Maintenance.
9-37
9 Result Printouts
5. Select Continue.
9.10.1 Introduction
Log reports are used to print the inquired error logs and delete/edit logs, which can be
respectively printed out on the Error Log and Delete/Edit Log screens.
NOTE
Printing logs will take a long time and requires a great number of papers. Think twice before
printing logs.
9-38
9 Result Printouts
3. Select Print F7. All error logs are printed out with the default template.
3. Select Print F7. All edit logs are printed out with the default template.
9-39
9 Result Printouts
9-40
10 Chemistries
10.1 Overview
This chapter introduces applications of chemistries, including:
• Definition and application of calculations
• Definition and application of panels
• Configuration and application of serum index
• Masking and unmasking of chemistries
• Chemistry configuration
• Definition and application of default panels
• Carryover setup
10.2.1 Introduction
Calculation of certain chemistries can derive new chemistries of clinical purposes, such as
A/G(ALB/(TP-ALB)), I-BIL (T-Bil - D-Bil), etc.
A calculation is composed of chemistries, calculation operators and algorithm. Only users
with sufficient permissions are allowed to define, modify and delete calculations. The system
allows a maximum of 50 calculations to be defined.
For the print order of calculations, refer to 9.3.3 Defining Chemistry Print Order (page 9-7).
1. Select Utility-Chemistries.
10-1
10 Chemistries
4. If you are going to use the calculation for analysis, mark the Enable checkbox.
10-2
10 Chemistries
• 0.1
• 0.01
• 0.001
• Choose chemistries in the Chemistries list. The chemistries are then displayed in
the Formula field.
• Choose numbers and operators in the Mathematical Symbols area to constitute
the calculation formula along with the chemistries.
• To remove a chemistry, number or operator, move the cursor behind them and select
BS.
• To clear the entire formula, select AC.
1. Select Utility-Chemistries.
10-3
10 Chemistries
1. Select Utility-Chemistries.
10-4
10 Chemistries
10.3 Panels
10.3.1 Introduction
A couple of chemistries combined together for certain clinical purposes can constitute a panel,
such as liver function, kidney function, etc. Panels can help fast programming of samples.
Panels can be composed of biochemistries and ISE chemistries except for SI and calculations.
The system allows a maximum of 100 panels to be defined. Only users with sufficient
permissions are allowed to define, modify and delete panels.
10-5
10 Chemistries
1. Select Utility-Chemistries.
• Sample: indicates that the panel can be used for sample analysis.
• QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to both sample and
control analysis.
At least one biochemistry should be selected. The three ISE chemistries (Na, K and Cl)
can be selected alone.
10-6
10 Chemistries
1. Select Utility-Chemistries.
10.5.1 Introduction
The Chemistry Configuration function is used to enable/disable chemistries that have been
defined correctly and customize their display order on the Sample, STAT Sample Program
and Quality Control screens. When disabled, chemistries will no longer appear on the
Sample, Reagent/Calibration, Quality Control, Define/Edit Panels, Special
10-7
10 Chemistries
Calculations, Current Results and History Results screens. Only the enabled chemistries
can be requested for measurements and recalled on results screens.
The system allows up to 200 chemistries to be enabled. The number of open-reagent
chemistries can be adjusted according to the practical situations in your laboratory.
The Chemistry Configuration screen is as shown below:
Figure 10.5 Chemistry Configuration screen
1. Select Utility-Chemistries.
4. Select Add->.
The selected chemistries are enabled and appear in the Configured Chemistries list.
10-8
10 Chemistries
All chemistries in the Available Chemistries list are enabled and displayed in the
Configured Chemistries list.
6. Select OK.
1. Select Utility-Chemistries.
4. Select <-Remove.
The selected chemistry is disabled and removed from the Configured Chemistries list.
All chemistries in the Configured Chemistries list that meet the requirements are
disabled. The disabled open-reagent chemistries are indicated in red.
If one of the chemistries does not satisfy the requirements, the operation will be aborted
and all the chemistries can not be disabled.
6. Select OK.
10-9
10 Chemistries
1. Select Utility-Chemistries.
5. Select OK.
10.6.1 Introduction
The Carryover Setup option is used to set up the carryover relations between open-reagent
chemistries and between cuvettes. The system will insert a cleaning to reagent probes and
cuvettes based on the carryover settings. The closed-reagent chemistries have been set up by
the manufacturer and cannot be viewed or edited, while the open-reagent chemistries need to
be set up on the Carryover window.
Carryover setup can only be performed by users with sufficient permissions when the system
status is not Running.
10-10
10 Chemistries
1. Select Utility-Chemistries.
4. Select OK F7.
10-11
10 Chemistries
1. Select Utility-Chemistries.
10.7.1 Introduction
The system allows a maximum of one default panel to be defined. When a bar-coded sample
has no relevant programming information on the LIS host or has not been programmed
manually, it can be analyzed with the default panel. The default panel is only applicable to
routine and emergent samples, and often used for a tremendous amount of samples that are
analyzed with the same chemistries. The default panel is often used at nighttime or weekends
to avoid complicated chemistry requisition.
Only a sample panel rather than control panel can be set as the default.
1. Select Utility-Chemistries.
10-12
10 Chemistries
• Sample: indicates that the panel can be used for sample analysis.
• QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to both sample and
control analysis.
At least one biochemistry should be selected. The three ISE chemistries (Na, K and Cl)
can be selected alone.
10.Mark the Default checkbox in the same row as the selected panel.
11.Select Close F8 to close the window.
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
10-13
10 Chemistries
5. Select OK.
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
5. Select OK.
10.8.1 Introduction
The chemistry masking function is used when a chemistry needs to be disabled temporarily
due to abnormal result or reagent exhaustion. The marked chemistry will have a symbol
appearing on its upper-left corner, and will still be displayed on the Sample, Quality
Control and Reagent/Calibration screens. Masked chemistries can be requested but cannot
be run until they are unmasked.
In any system status chemistries can be masked or unmasked. Any users are allowed to mask
or unmask chemistries.
If a sample contains masked chemistries, it will enter the Incomplete status when finished; if
10-14
10 Chemistries
chemistries are unmasked while the sample status is Programmed, the they will be run along
with other chemistries; if chemistries are unmasked while the sample is being analyzed, they
will be added automatically to the analysis; if chemistries are unmasked after the sample is
analyzed, they will be run automatically when analysis begins next time.
10-15
10 Chemistries
10-16
11 System Commands and Setup
Options
11.1 Overview
This chapter provides descriptions of system commands and advanced setup options.
The system commands include:
• Home
• Stop print
• Wake up
The advanced setup options include:
• User and password setup
• System timers for auto sleep, auto startup and auto shutdown
• Software version upgrading
• Software version
The system commands and setup options are introduced in detail in the following sections.
11.2 Home
11.2.1 Introduction
The Home command is used to initialize the biochemistry system and the ISE module, and to
recover them from failures, making all components return to the home positions. When the
Home command is executed, the system status becomes Standby.
11-1
11 System Commands and Setup Options
1. Select Utility-Commands.
3. When the home procedure is finished, the Wait window will be closed automatically.
11.3.1 Introduction
The Stop Print command will stop all print requests in the print queue and prevent them from
being sent to the printer. This feature is used for stopping print requests of many pages, such
as error logs, QC reports, multi-sample reports, etc. The print tasks that are Printing, Deleted,
Canceling or Canceled in the print task window will not be deleted.
1. Select Utility-Commands.
2. Select Stop Print. All print requests in the print queue will be removed.
11.4 Wake Up
11.4.1 Introduction
Wake Up will activate the system that enters the Hibernating status automatically. Except for
Wake Up, the system can also be activated based on the set auto awake time.
For more information about auto sleep and wake up, refer to 11.6 Auto Awake and Startup
Setup (page 11-7).
1. Select Utility-Commands.
11-2
11 System Commands and Setup Options
11.5.1 Introduction
Users can be defined, deleted or modified on the User and Password window. The system
allows up to 100 users to be defined and belonged to two user groups: administrator and
operator. Administrators are allowed to assign permissions for operators.
Figure 11.1 User and Password window
NOTE
The default username and password for administrator is Admin. Please note that the password
is case sensitive. You are recommended to change the password when logging on the system
for the first time in order to prevent others from abusing the privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the system and
delete the username and then redefine a username; or he may contact our customer service
department or your local distributor. If the administrator forgets his password, contact our
customer service department or your local distributor.
11-3
11 System Commands and Setup Options
11-4
11 System Commands and Setup Options
8. Select Modify.
3. Select Permission.
11-5
11 System Commands and Setup Options
• To assign new permissions, select the box in front of the relevant operation. The
select button changes to Yes.
• To cancel permissions, deselect the box in front of the relevant operation. The select
button changes to No.
4. Select Delete.
5. Select OK.
11-6
11 System Commands and Setup Options
11.6.1 Introduction
The Auto Awake/Shutdown feature includes the Auto Sleep Setup, Auto Awake Setup, and
Auto Shutdown Setup options.
The Auto Sleep Setup option is used to set up the time interval of auto sleep time of the
system. After the sleep time interval is set up, a countdown will begin from the moment that
the system status becomes Standby. When the time interval is elapsed, the system will begin
sleeping. Except for the auto sleep setting, the system can be woken up by means of the wake
up command.
The Auto Awake Setup and Auto Shutdown Setup option allow you to define a date and time
to start up or shut down the system. When the auto awake time is reached, the system will be
started up or woken automatically no matter if it is off or sleeping; when the auto shutdown
time is reached, the system will shut down automatically if it is running.
11-7
11 System Commands and Setup Options
The options include N/A, 30, 60, 90, 120, 150 and 180, and the default is 60 minutes.
N/A means the auto sleep timer is disabled.
6. Select Save.
When the interval is elapsed, the system will starts to sleep and the system status
becomes Sleep.
7. Select Exit.
11-8
11 System Commands and Setup Options
5. Choose the weekday for auto startup, and then set up the specific time.
Any time within a week(from Monday to Sunday) can be defined for the system to start
up automatically.
6. Select Save.
When the date and time is reached, the system will be started up or woken automatically
no matter if it is off or sleeping.
7. Select Exit.
11-9
11 System Commands and Setup Options
5. Choose the weekday for auto shutdown, and then set up the specific time.
Any time within a week(from Monday to Sunday) can be defined for the system to shut
down automatically.
6. Select Save.
When the time is reached, the system will shut down automatically if it is running.
7. Select Exit.
11.7.1 Introduction
Software Upgrade is used to upgrade the operating software, control software and ISE module
software. When software versions is upgraded, the original data, including those in the
database and saved in files, will not be destroyed and can be compatible with the new
versions.
11-10
11 System Commands and Setup Options
4. Insert the U disk containing the software into the USB interface of the computer.
11.8.1 Introduction
You are allowed to view the version number of the operating software and control software in
any system status.
11-11
11 System Commands and Setup Options
4. View the version number of the operating software and control software.
If a new version is released, upgrade the operating software while referring to 11.7
Software Upgrade (page 11-10). If no ISE module is configured, the ISE Software
Version area will be blank.
5. To view the version numbers of the smart module software, select Details.
11-12
11 System Commands and Setup Options
7. Select OK.
11-13
11 System Commands and Setup Options
11-14
12 Use of ISE Module
12.1 Overview
This chapter introduces the ISE module in the following aspects:
• Precautions on use
• Principles of measurement
• Chemistry parameters setup
• Preparing reagents for analysis
• Running ISE chemistries
• Results recall
• Startup primes and calibration factor expiration date
12.2.1 Introduction
Read the following precautions thoroughly prior to using the ISE module.
Warning
The ISE module must be operated by skilled/trained doctors, nurses or clinical professionals.
12-1
12 Use of ISE Module
Warning
Exercise caution while using the ISE module. Prevent your hair, legs or other parts of your
body from being hurt by the driver parts.
BIOHAZARD
The serum samples remaining in the electrodes may contain a great number of viruses. Wear
gloves to prevent infection while operating around the electrodes.
Electrode precautions
CAUTION
The inner solution inside the electrodes will run off as the electrodes are used. If you find that
the inner solution inside an electrode decreases, weigh the electrode. If the electrode weighs
less than 9g, stop using it; otherwise, the measuring performance will be influenced.
The Cl electrode is vulnerable to vibrations. Use the Cl electrode carefully to prevent damage.
Calibration precautions
CAUTION
Calibrate the ISE chemistries for serum and urine before starting the measurement. If the
result of a chemistry is based on the calibration factors of another chemistry, it may not be
accurate enough.
After changing the buffer solution, electrodes or other consumables, perform a calibration.
You are recommended to perform calibration at lease once everyday to ensure accurate
results.
BIOHAZARD
The buffer solution and calibrators contain preservatives. In case your skin contacts the buffer
solution or calibrators, wash them off with soap and water. In case the buffer solution and
calibrators spill into your eyes, rinse them with water and consult an oculist. If you swallow
them by mistake, see a doctor.
12-2
12 Use of ISE Module
CAUTION
Use the buffer solution and calibrators specified by our company. Use of other reagents or
calibrators may result in unreliable results, or damage the Hydropneumatic system, or even
shorten the electrodes life span.
Prior to using the buffer solution and calibrators, check if they are within the expiration date.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module damage.
BIOHAZARD
The ISE wash solution is sodium hypochlorite. Use the ISE wash solution carefully to prevent
it from contacting your skins or eyes. If your skins or eyes contact the ISE wash solution,
rinse them off with fresh water and consult a doctor.
12-3
12 Use of ISE Module
12.4.1 Introduction
The ISE module measures the concentration of K+, Na+ and Cl- ions contained in human
body fluid by means of electrodes, helping diagnosis of electrolyte disturbance, body fluid
equilibrium, and other relevant diseases.
The ISE chemistries are applicable to serum and urine, and the default sample type is serum.
If the sample is of a type other than serum and urine, it will be analyzed with the chemistry
parameters for serum.
The system allows the ISE chemistry parameters to be viewed, modified and reconfigured.
Only administrators are allowed to modify ISE chemistry parameters.
12-4
12 Use of ISE Module
1. Select Utility-Chemistries.
• Calibrate replicates
• Dilution coefficient
• Temperature correction coefficient
• Ion concentration of H-CAL
• Ion concentration of L-CAL
• EMF of H-CAL
• EMF of L-CAL
12-5
12 Use of ISE Module
• Slope range
• Concentration of buffer
• Gain
• Calibration tolerance
• Decimal
• Result unit
• Reagent uncapping time
1. Select Utility-Chemistries.
5. Enter the print names for Na, K and Cl in the Print Name field.
12-6
12 Use of ISE Module
1. Select Utility-Chemistries.
6. Select Save F7 to save your modification and configure it for the ISE module.
• Discard F6
• Restore Def F1
Dilution coefficient
The Dilution Coefficient indicates the allowable range of dilution factor obtained in
calibration. If the dilution factor is beyond the range, a flag will appear on patient reports. For
more information about result flags, refer to 17.5 Data Alarm (page 17-12).
12-7
12 Use of ISE Module
• The low limit of the range must be within 1-100, and the default is 25.0.
• The high limit of the range must be within 1-100, and the default is 60.0.
• Make sure that the high limit is greater than the low limit; otherwise, the system will
display a message indicating input range error.
Na chemistry parameters
Configure the following parameters for the Na chemistry:
• Temperature correction coefficient
• Concentration of H-CAL: Na concentration of high-concentration calibrator
• Concentration of L-CAL: Na concentration of low-concentration calibrator
• EMF of H-CAL: electromotive force of Na ion in high-concentration calibrator
• EMF of L-CAL: electromotive force of Na ion in low-concentration calibrator
• Slope range
• Concentration of buffer: Na concentration of buffer solution
• Gain
12-8
12 Use of ISE Module
K chemistry parameters
Configure the following parameters for the K chemistry:
• Temperature correction coefficient
• Concentration of H-CAL: K concentration of high-concentration calibrator
• Concentration of L-CAL: K concentration of low-concentration calibrator
• EMF of H-CAL: electromotive force of K ion in high-concentration calibrator
• EMF of L-CAL: electromotive force of K ion in low-concentration calibrator
• Slope range
• Concentration of buffer: K concentration of buffer solution
• Gain
12-9
12 Use of ISE Module
Cl chemistry parameters
Configure the following parameters for the Cl chemistry:
• Temperature correction coefficient
• Concentration of H-CAL: Cl concentration of high-concentration calibrator
• Concentration of L-CAL: Cl concentration of low-concentration calibrator
• EMF of H-CAL: electromotive force of Cl ion in high-concentration calibrator
• EMF of L-CAL: electromotive force of Cl ion in low-concentration calibrator
• Slope range
• Concentration of buffer: Cl concentration of buffer solution
• Gain
12-10
12 Use of ISE Module
Calibration tolerance
Calibration Tolerance is the difference of replicate results of a calibrator and used to check the
accuracy of ISE chemistry calibration. If the obtained difference is beyond the calibration
tolerance range, a flag will appear on patient reports. For more information about result flags,
refer to 17.5 Data Alarm (page 17-12).
Define the calibration tolerance according to the table below:
12-11
12 Use of ISE Module
Decimal
Decimal specifies the number of decimal places for test results. It can be defined for each of
K, Na and Cl chemistries of serum and urine samples.
The range is 0-6 decimal places, and the default is 0.1.
Unit
The result unit for K, Na and Cl is mmol/L, and cannot be viewed rather than modified. The
result unit has nothing to do with the sample type and is the same(mmol/L) for all sample
types.
Uncapping time
The uncapping time is the number of days that the reagent can be kept valid since uncapped at
the first time.
The input range is 1-999, and the default is 60.
12.5.1 Introduction
The ISE reagent pack includes the buffer solution and wash solution, which are respectively
placed in the analyzer’s cabinet and on the sample carousel. When the ISE module is removed
from the system, the ISE buffer solution and wash solution that have been loaded will be
deleted automatically. Install and replace ISE reagents as instructed below.
12-12
12 Use of ISE Module
2. Select Reagent-Reagent/Calibration.
(1)
(1) ISE buffer solution
• Volume (required)
• Number of primes (required)
• Serial number
• Expiration date (required)
• Lot number
9. Select Load. The system will prime the ISE module for the specified times.
12-13
12 Use of ISE Module
3. Place the ISE wash solution in position D4 (No.139) of the inner sample carousel.
12-14
12 Use of ISE Module
are finished.
When a new buffer is loaded, the default volume is 100%. The volume can be changed within
5%-100%.
1. Select Reagent-Reagent/Calibration.
2. Check the buffer volume. If the volume is insufficient, go to the next step.
5. When the countdown is finished, select Load F1 again. The Load Reagent window is
displayed.
Figure 12.5 Load ISE reagent window
6. Open the front door of the analyzer, and then remove the ISE buffer.
• Volume %
• Number of primes
12-15
12 Use of ISE Module
• Serial number
• Expiration date
• Lot number
10.Select Load.
11.Select Exit to close the window.
3. Remove the ISE wash solution from position D4 (No.139) of the inner sample carousel.
12.6.1 Introduction
You should define the ISE calibrators and assign positions for them prior to running a
calibration. Current calibration factors and all intermediate data are provided on the ISE
Calibration screen. Calibration results can be printed out or archived to an external storage
12-16
12 Use of ISE Module
device. The Trend option is provided to enable you to view the calibration trends of ISE
chemistries during a period of time. When the calibration factors are expired, the Extend
Calibration Time can help prolonging their validity period for measurement.
1. Select Reagent-Reagent/Calibration.
12-17
12 Use of ISE Module
The input range is 1-9999, and the default is 24 hours. If the field is left blank, it
indicates that the calibration factors can be always used.
You are allowed to assign one position of each sample carousel for the calibrator. The
fourth ring (center) of the sample carousel is used to carry calibrators and controls. You
may also place the calibrator on other idle positions of the sample carousel.
12-18
12 Use of ISE Module
1. Select Reagent-Reagent/Calibration.
12-19
12 Use of ISE Module
4. Select on upper right corner of the main screen. The Start Conditions window is
displayed.
12-20
12 Use of ISE Module
12-21
12 Use of ISE Module
The screen shows the calibration factors that are being used for calculating results.
2. To recall the history calibration results of a chemistry, choose one from the Chem
pull-down list.
3. Select the History option button, and then select date range that the chemistry is
calibrated.
The calibration results of the chemistry are displayed in the result list.
12-22
12 Use of ISE Module
• Calibrator F1: to view the calibrators used in calibrating the ISE chemistry.
• Reagent F2: to view the reagents used in the calibration.
• Print F7: to print the current calibration data.
12-23
12 Use of ISE Module
The screen shows the calibrators used for calibrating the chemistry, including the
calibrator name, concentration and lot number.
Figure 12.11 Calibrator Information window
The screen shows the reagents used in calibration of the chemistry, including reagent
name, lot number and serial number.
12-24
12 Use of ISE Module
4. Choose desired trend type and calibration date range, and then select Search F1.
The trend of the chemistry within the specified time period is displayed on the screen.
The trend type options will not include Reference Electrode when trends of ISE Urine
are being recalled.
12-25
12 Use of ISE Module
• Prev F4: to view the calibration trends and data of the previous chemistry.
• Next F5: to view the calibration trends and data of the next chemistry.
• Print F7: to print the current graphic trend or data.
12-26
12 Use of ISE Module
1. On the ISE Calibration screen choose a chemistry from the Chem pull-down list.
2. Select the History option button, and then select date range that the chemistry is
calibrated.
The calibration results satisfying the conditions are displayed in the result list.
The selected calibration results are set as default and will be used for sample result
calculation.
5. Select Save.
1. Select Reagent-Reagent/Calibration.
12-27
12 Use of ISE Module
5. Select OK. The calibration factors of the selected chemistry can be used without time
limit.
12-28
12 Use of ISE Module
Nevertheless, the ISE chemistries are slightly different from biochemistries for that they do
not support the measurement with increased or decreased or prediluted samples.
For the operating procedure of sample analysis, refer to 2.8 Programming Routine Samples
(page 2-30).
ISE test results have no reaction curves and can be recalled in the same way as other
chemistries. Refer to 8 Sample Programming and Processing (page 8-1) for details.
12-29
12 Use of ISE Module
• Sample Blank F2: to view the sample blank reaction curve and reaction data of the
selected sample.
• Prev F4: to view the reaction curve and data of the previous chemistry.
• Next F5: to view the reaction curve and data of the next chemistry.
• Print F7: to print the current reaction curve or data.
12.9.1 Introduction
When the reagent inventory is lower than the alarm limit during or before the analysis, the
system will give an alarm and display the volume of ISE reagent and wash solution as 0 on
the Reagent/Calibration screen.
12-30
12 Use of ISE Module
The alarm limit is applicable to the ISE reagent, reagent probe wash solution,
physiological saline and sample probe wash solution. The input range is 5%-50%, and
the default is 15%.
12.10.1 Introduction
While the analyzer is started up, the ISE module will prime automatically to replace the
reagents inside of it with fresh reagents. The number of primes can be defined on the System
12-31
12 Use of ISE Module
Setup screen.
Only administrators are allowed to define or modify the startup prime times.
2. Type in the number of startup primes in the ISE Startup Prime Cycle field.
12-32
12 Use of ISE Module
12-33
12 Use of ISE Module
• Alarm: displaying alarm messages and recording them in error logs without influencing
the tests.
• Invalidating current tests: invalidating the tests that are currently being run.
• Measurement stop: stopping the measurement after finishing the tests that have been
started.
• Emergent stop: terminating all ISE tests immediately.
For troubleshooting of the ISE module, refer to 17 Alarms and Troubleshooting (page 17-1).
12-34
13 Use of Bar Code
13.1 Overview
The setup and operation instructions of the sample bar code reader and the reagent bar code
reader are depicted in this chapter. The sample bar code reader is used to identify samples and
obtain sample information by scanning the bar code label applied on sample tubes. The
reagent bar code reader scans the bar code labels automatically when the reagents are loaded.
13.2.1 Introduction
The sample bar code reader obtains sample information from the bar code label. When
bar-coded samples are loaded to the sample carousel, the system will make a full scan and
locate samples through the bar code.
13-1
13 Use of Bar Code
Name Description
Maximum width 55mm
Maximum height 10mm
Maximum inclination angle ±5º
Print quality No less than Class C according to the ANSI MH10.8M
Print Quality Specification.
Width and narrowness 2.5-3.0:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or degraded
bar code label. You are not suggested to print bar code on
common print paper.
5. Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:
• Codabar
• Interleaved 2 of 5
13-2
13 Use of Bar Code
• Code128
• Code39
• UPC/EAN
• Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default and cannot be
modified. A check digit is not required for other symbologies.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
7. Select OK.
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
13-3
13 Use of Bar Code
2. Select Program-Sample.
• All programmed samples: to download all samples programmed on the current day.
• Latest samples: to download samples that are programmed on the current day but
have not been downloaded.
• Sample with the following IDs: to download samples with the specified program
date and ID. Type in the single sample ID or ID range in the edit box.
• Sample with the following bar code: to download the sample with the specified bar
code. Enter the bar code of the desired sample.
5. Select OK.
7. Confirm the requested chemistries, and if necessary, choose the following buttons to edit
13-4
13 Use of Bar Code
1. Select Program-Sample.
Up to 30 characters can be entered. The input characters must be within ASCII 33-126,
exclusive of the following:
• Space
• Dollar sign ($)
• Comma (,)
• Semicolon (;)
• Asterisk (*)
• Question mark (?)
13-5
13 Use of Bar Code
• Sample type
• Sample comments
• Chemistries and panels
• Sample volume, sample cup type, replicates and dilution factors
For details of manual programming, refer to 2.8.1 Programming Routine Samples (page
2-30).
13-6
13 Use of Bar Code
2. Select Program-Sample.
• All programmed samples: to download all samples programmed on the current day.
• Latest samples: to download samples that are programmed on the current day but
have not been downloaded.
• Sample with the following IDs: to download samples with the specified program
date and ID. Type in the single sample ID or ID range in the edit box.
• Sample with the following bar code: to download the sample with the specified bar
code. Enter the bar code of the desired sample.
5. Select OK.
8. Confirm the requested chemistries, and if necessary, choose the following buttons to edit
Quick STAT:
13-7
13 Use of Bar Code
2. Select Program-Sample.
• All programmed samples: to download all samples programmed on the current day.
• Latest samples: to download samples that are programmed on the current day but
have not been downloaded.
• Sample with the following IDs: to download samples with the specified program
date and ID. Type in the single sample ID or ID range in the edit box.
• Sample with the following bar code: to download the sample with the specified bar
code. Enter the bar code of the desired sample.
5. Select OK.
7. Confirm the requested chemistries, and if necessary, choose the following buttons to edit
13-8
13 Use of Bar Code
After locating a sample by entering the bar code, you are allowed to manually program the
sample for analysis.
Common STAT:
1. Select Program-Sample.
Up to 30 characters can be entered. The input characters must be within ASCII 33-126,
exclusive of the following:
• Space
• Dollar sign ($)
• Comma (,)
13-9
13 Use of Bar Code
• Semicolon (;)
• Asterisk (*)
• Question mark (?)
• Left square bracket ( [ )
• Right square bracket ( ] )
• Backlash (\)
• Caret (^)
• Vertical bar (|)
• Ampersand (&)
• Sample type
• Sample comments
• Chemistries and panels
• Sample volume, sample cup type, replicates and dilution factors
For details of manual programming, refer to 2.8.1 Programming Routine Samples (page
2-30).
Quick STAT:
2. Enter the sample ID. The first emergent sample on each day is numbered as 9001.
13-10
13 Use of Bar Code
Up to 30 characters can be entered. The input characters must be within ASCII 33-126,
exclusive of the following:
• Space
• Dollar sign ($)
• Comma (,)
• Semicolon (;)
• Asterisk (*)
• Question mark (?)
• Left square bracket ( [ )
• Right square bracket ( ] )
• Backlash (\)
• Caret (^)
• Vertical bar (|)
• Ampersand (&)
• Sample type
• Sample injection cup (SIC)
• Chemistries
• Patient demographics
For details of manual programming, refer to 2.9.1 Programming STAT Samples (page
2-41).
13-11
13 Use of Bar Code
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles. In case
your skin contacts the samples, follow standard laboratory safety procedure and consult a
doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
1. Select the icon on the upper-right corner of the main screen to request for sample
stop.
2. Check the sample stop countdown in the system status area and wait until it comes to 0.
3. Check the sample carousel indicators, and proceed to the next step when the indicators
are extinguished.
• Flash: indicates that the corresponding carousel is rotating or will start to rotate after
2 periods.
• ON: indicates that the corresponding carousel is stopped for sample aspirating.
• Off: indicates that the corresponding carousel has no sample being aspirated and
will not rotate in the next 2 periods.
4. Place the bar-coded samples on the idle positions of the sample carousel.
• If the system is running tests, it will analyze the added samples automatically.
• If the system is not running any tests,
13-12
13 Use of Bar Code
The sample volume is the same as that defined for the chemistry. If increased and
decreased volumes are defined for the chemistry, Increased and Decreased are available
here for selection.
The input range must be within 4-201. The default is blank, which indicates that the
sample needs not to be prediluted before being analyzed.
6. Select OK.
13-13
13 Use of Bar Code
4. To change the sample volume and dilution factor, select Options F2, and then do
necessary settings.
Starting analysis
1. Check that the rerun samples have been loaded to the sample carousel.
2. If the system is running tests, it will automatically scan all sample positions and then
3. If the system status is Standby, select the icon on the upper-right corner of the
main screen.
4. Select the sample carousel on which the samples are located, and then select OK.
The screen shows all incomplete samples and controls, as well as those programmed and
analyzed on the current day.
13-14
13 Use of Bar Code
2. Choose a sample in the left list. The right list displays all results of the sample.
13-15
13 Use of Bar Code
13.3.1 Introduction
The reagent bar code reader obtains reagent information from the bar code label. When
bar-coded reagents are loaded to the reagent carousel, the system will make a full scan and
obtain reagent information from the bar code labels.
13-16
13 Use of Bar Code
4. Choose a bar code symbology and set up the check digit status.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
13-17
13 Use of Bar Code
• Type in the total length of the reagent bar code in the T field. The input range is
13-30 digits. The Interleaved 2 of 5 only supports bar code of even number length.
• Type in the start digit of the reagent bar code in the S field.
• Type in the end digit of the reagent bar code in the E field.
• Type in the number of digits for reagent information in the Digits field.
• Type in the start digit of the reagent information in the S field.
• Type in the end digit of the reagent information in the E field.
7. Select OK.
13-18
13 Use of Bar Code
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation may
be caused.
CAUTION
If the system is running tests, after requesting reagent stop do not remove the reagent
carousel cover until the countdown for reagent stop is 0; otherwise, the tests currently
run will be invalidated.
NOTE
While loading reagents, select Rotate F1 to rotate the selected position to the front, or
press the load buttons near the reagent carousel to rotate the outer ring and inner ring for
convenient loading. When the reagent load button is pressed, the corresponding ring will
rotate counterclockwise for 1/4 circle.
13-19
13 Use of Bar Code
4. Restore the reagent carousel cover. The system scans all reagent positions automatically
13.4.1 Introduction
The sample and reagent bar code readers are located inside the analyzing unit and need not to
be maintained. You are only required to regularly check the bar code scanning window, and
clean them if dust or other stains, such as sample and reagent, accumulate.
3. Use clean gauze to clean the bar code reader windows inside the reagent compartment. If
necessary, you can use gauze soaked with ethanol or deionized water. Make sure that
there is no trace or dust left on the glass.
4. Use clean gauze soaked with deionized water or ethanol to clean the reagent carousel,
and then use cotton swabs dipped with ethanol to clean the reagent positions.
13-20
14 LIS and RMS
14.1 Overview
The chapter provides detailed description of the LIS and RMS.
Laboratory Information System (LIS) is an external host computer connected with the
chemistry analyzer through a fixed interface. The LIS is used to download sample program
information to the analyzer and receives results sent from the analyzer.
You should set up the communication parameters and results transmission methods prior to
using the LIS host.
Check that your analyzer is equipped with a LIS. If needed, contact our customer service
department or your local distributor.
Remote Maintenance System (RMS) provides a platform of remote diagnosis and
maintenance based on the internet. The RMS allows transfer of data and files with the
chemistry analyzers in hospitals, and helps the service engineers to find, collect, analyze,
locate and solve the failures happening at the user end.
14.2.1 Introduction
The host communication parameters, such as transmission mode, IP address and port, should
be set up prior to use of the LIS host. To download sample program information from or sent
results to the host, you need to set up the chemistry code used for identification of chemistries
on both the LIS host and the analyzer, which, otherwise, cannot identify the chemistries
simultaneously.
14-1
14 LIS and RMS
5. Select OK.
14-2
14 LIS and RMS
14-3
14 LIS and RMS
Parameter Description
Protocol Choose a protocol for connection between the analyzer and
the LIS host from the Protocol pull-down list. The options
include HL7 and ASTM 1394.
Data transmission Choose a data transmission mode for the analyzer and LIS
mode host. The available options are Blank, Unidirectional and
Bidirectional. Blank: indicates the data transmission of the
LIS host is disabled.
• Unidirectional: You are only allowed to send results and
patient demographics to the host rather than
downloading sample programs from it.
• Bidirectional: You are allowed to send results and patient
demographics to the host and downloading sample
programs from it.
Send Results after When the checkbox is selected, the system will
Each Sample Run automatically send results to the LIS host after each test is
finished.
Communication time Enter the time out limit for querying the LIS host. The input
out range is 30s-60s, and the default is 30s.
If the time out limit is exceeded when you attempt to
download sample programs from, or send results to, or
connect the analyzer with the LIS host, the system will give
an alarm indicating communication timed out.
3. View the chemistry channel number list on the right of the window.
The screen shows the chemistries and code in two columns. The left column provides all
chemistries that have been defined and set up correctly; the right column shows the code
for identifying a chemistry on the LIS host.
4. Click on the Channel No. column of a chemistry, and then type in a code for it.
14-4
14 LIS and RMS
6. Select Save.
14.3.1 Introduction
Sample programming information can be sent by or downloaded from the LIS host, and then
the measured results are sent to it manually or in real-time mode.
Both bar-coded and non-bar-coded samples can be programmed with the LIS host. When a
sample bar code module is configured, the system will automatically identify samples and
match them with the programming information downloaded from the host. If there is no
sample bar code module, you should manually assign positions for the downloaded samples.
1. When samples are sent from the LIS host to the analyzer, select Program-Sample.
3. Only the Sample screen, type in the sample ID, and then confirm the program
information.
14-5
14 LIS and RMS
1. After program samples on the LIS host, send them to the analyzer, and then select
4. Select Assign.
The options include all available positions of the selected sample carousel.
• To assign position for single sample, input the position number in the first edit box.
• To assign positions for multiple samples, enter the start position number in the first
edit box, and then the end position number in the second edit box. The system will
assign positions for the samples ascending according to the sample ID.
• If the available positions among the specified range are more than or equal to the
number of samples, the extra positions will be neglected.
• If the available positions among the specified range are less than the number of
samples, the system will display a message indicating insufficient positions. Assign
the positions again.
9. Select OK.
10.Enter the sample ID on the Sample screen and edit the following information:
• Position
• STAT status
14-6
14 LIS and RMS
• Sample type
• Comment
• Chemistries and panels
• Sample options and chemistry options
1. Select Program-Sample.
• All programmed samples: to download all samples programmed on the current day.
• Latest samples: to download samples that are programmed on the current day but
have not been downloaded.
• Sample with the following IDs: to download samples with the specified program
date and ID. Enter the sample IDs or ID range to download.
• Sample with the following bar code: to download the sample with the specified bar
code. Enter the bar code of the desired sample.
4. Select OK.
14-7
14 LIS and RMS
1. Select Program-Sample.
• All programmed samples: to download all samples programmed on the current day.
• Latest samples: to download samples that are programmed on the current day but
have not been downloaded.
• Sample with the following IDs: to download samples with the specified program
date and ID. Enter the sample IDs or ID range to download.
4. Select OK.
7. Select Assign.
14-8
14 LIS and RMS
• If the available positions among the specified range are more than or equal to the
number of samples, the extra positions will be neglected.
• If the available positions among the specified range are less than the number of
samples, the system will display a message indicating insufficient positions. Assign
the positions again.
12.Select OK.
13.Enter the sample ID on the Sample screen and edit the following information:
• Position
• STAT status
• Sample type
• Comment
• Chemistries and panels
• Sample options and chemistry options
14.4.1 Introduction
Sample results and QC results can be sent manually or in real-time mode to the LIS host for
reviewing and storage. When a sample is analyzed with its all tests finished, the system can
automatically send the test results to the LIS host; also you are allowed to search for desired
results and then manually send them to LIS.
Patient demographics, sample results and QC results can be sent to the LIS host.
Patient demographics:
• Patient name
• Gender
• Age
• Patient ID
• Patient location
• Bed
14-9
14 LIS and RMS
• Clinical diagnosis
• Ordering physician
• Ordering date
• Run date
• Tester
• Sample feature
• Ordering department
• Attending physician
• Social security number
• Contact
• Blood type
Sample results:
• Sample type
• Sample bar code
• Sample ID
• Run date
• Sample status
• Chemistry number
• Chemistry name
• Result
• Unit
• Original result
Control results:
• Chemistry number
• Chemistry name
• Run date
• Control number
• Control name
• Lot number
• Expiration date
• Concentration level
• Standard deviation
• Result
14-10
14 LIS and RMS
(that is currently displayed on the Current Results screen) is sent to the LIS host. The
results of all replicates of a sample or chemistry will sent to the LIS host.
A sample will be sent to the LIS host automatically when all chemistries requested for
the sample are run and at least one of them has result.
If you won’t send results, deselect the checkbox.
4. Select Save.
• Selected sample(s)
• All sample(s)
6. If you transmit all samples, you are allowed to skip those that are already transmitted to
7. Select OK.
14-11
14 LIS and RMS
17-1).
14.6.1 Introduction
The RMS provides a platform of remote diagnosis and maintenance based on the internet. The
RMS allows transfer of data and files with the chemistry analyzers in hospitals, and helps the
service engineers to find, collect, analyze, locate and solve the failures happening at the user
end. Before connecting the analyzer with the RMS, you should set up the IP address of the
operation unit PC.
14-12
14 LIS and RMS
• Following IP Address: type in the IP address for connecting the operation unit PC
with the LIS host/RMS.
5. Select OK.
14-13
14 LIS and RMS
14-14
BS-800 Chemistry Analyzer
Operator’s Manual
Maintenance Volume
Contents
Preface································································································· iv
Safety Information···················································································· 1
Safety Symbols ...............................................................................................................................................1
Summary of Hazards ......................................................................................................................................2
Introduction.........................................................................................................................................2
Electric Shock Hazards.......................................................................................................................2
Moving Parts Hazards.........................................................................................................................2
Photometer Lamp Hazards..................................................................................................................3
Sample, Calibrator and Control Hazards ............................................................................................3
Reagent and Wash Solution Hazards ..................................................................................................3
Waste Hazards.....................................................................................................................................4
System Disposal Hazards....................................................................................................................4
Fire and Explosion Hazards................................................................................................................4
Precautions on Use .........................................................................................................................................5
Introduction.........................................................................................................................................5
Intended Use .......................................................................................................................................5
Environment Precautions....................................................................................................................5
Installation Precautions.......................................................................................................................5
Electromagnetic Noise Precautions ....................................................................................................6
Operating Precautions.........................................................................................................................7
Maintenance and Servicing Precautions .............................................................................................8
Chemistry Parameter Configuration Precautions................................................................................8
ISE Module Precautions .....................................................................................................................8
I
Contents – Maintenance Volume
Sample Precautions.............................................................................................................................9
Reagent, Calibrator and Control Precautions......................................................................................9
Data Archiving Precautions ..............................................................................................................10
External Equipment Precautions.......................................................................................................10
External Air Pump Precautions.........................................................................................................10
Labels............................................................................................................................................................10
Introduction.......................................................................................................................................10
Non-Warning Labels.........................................................................................................................11
Warning Labels .................................................................................................................................14
Contents ·································································································I
1 System Description·············································································· 1-1
1.1 Overview .............................................................................................................................................. 1-1
1.2 Installation Requirements and Procedure ............................................................................................. 1-1
1.2.1 Installation Requirements ...................................................................................................... 1-1
1.2.2 Installation Procedure ............................................................................................................ 1-5
1.3 Hardware Structure ............................................................................................................................... 1-6
1.3.1 System Overview................................................................................................................... 1-6
1.3.2 Sample Handling System....................................................................................................... 1-8
1.3.3 Reagent Handling System.................................................................................................... 1-13
1.3.4 Reaction System .................................................................................................................. 1-19
1.3.5 Cuvette Wash Station ........................................................................................................... 1-20
1.3.6 Photometric System ............................................................................................................. 1-21
1.3.7 Mixer Assembly................................................................................................................... 1-22
1.3.8 Operation Unit ..................................................................................................................... 1-24
1.3.9 Output Unit .......................................................................................................................... 1-24
1.3.10 Accessories and Consumables ........................................................................................... 1-25
1.3.11 Data Management Software............................................................................................... 1-25
1.4 Optional Modules ............................................................................................................................... 1-25
1.4.1 Introduction.......................................................................................................................... 1-25
1.4.2 ISE Module.......................................................................................................................... 1-26
1.4.3 Built-in Sample Bar Code Reader........................................................................................ 1-26
1.4.4 RMS..................................................................................................................................... 1-27
1.4.5 Water Supply Module .......................................................................................................... 1-27
1.4.6 External Air Pump ............................................................................................................... 1-29
1.4.7 Other Optional Modules ...................................................................................................... 1-30
1.5 Software Description .......................................................................................................................... 1-30
1.5.1 Main Screen ......................................................................................................................... 1-30
1.5.2 Function Buttons and Program Structure............................................................................. 1-33
1.5.3 Using a Mouse ..................................................................................................................... 1-39
II
Contents – Maintenance Volume
III
Contents – Maintenance Volume
IV
Contents – Maintenance Volume
V
Contents – Maintenance Volume
VI
Contents – Maintenance Volume
VII
Contents – Maintenance Volume
VIII
Contents – Maintenance Volume
IX
Contents – Maintenance Volume
X
Contents – Maintenance Volume
10 Chemistries ····················································································10-1
10.1 Overview .......................................................................................................................................... 10-1
10.2 Special Calculations.......................................................................................................................... 10-1
10.2.1 Introduction........................................................................................................................ 10-1
10.2.2 Defining/Editing a Calculation .......................................................................................... 10-1
10.2.3 Enabling/Disabling Calculations ....................................................................................... 10-3
10.2.4 Deleting User-Defined Calculations .................................................................................. 10-4
10.2.5 Running Calculations......................................................................................................... 10-5
10.3 Panels................................................................................................................................................ 10-5
10.3.1 Introduction........................................................................................................................ 10-5
10.3.2 Defining/Editing a Panel.................................................................................................... 10-6
10.3.3 Deleting Panels .................................................................................................................. 10-7
10.3.4 Running Panels .................................................................................................................. 10-7
10.4 Serum Index...................................................................................................................................... 10-7
10.5 Chemistry Configuration .................................................................................................................. 10-7
10.5.1 Introduction........................................................................................................................ 10-7
10.5.2 Enabling Chemistries......................................................................................................... 10-8
10.5.3 Disabling Chemistries........................................................................................................ 10-9
10.5.4 Customizing Chemistry Display Order............................................................................ 10-10
10.6 Carryover Setup .............................................................................................................................. 10-10
10.6.1 Introduction...................................................................................................................... 10-10
10.6.2 Defining/Editing Carryover Pair...................................................................................... 10-11
10.6.3 Removing a Carryover Pair ............................................................................................. 10-12
10.7 Default Panel .................................................................................................................................. 10-12
10.7.1 Introduction...................................................................................................................... 10-12
10.7.2 Defining the Default Panel .............................................................................................. 10-12
10.7.3 Running Default Panel for Routine Samples ................................................................... 10-13
10.7.4 Running Default Panel for Emergent Samples ................................................................ 10-14
10.8 Masking/Unmasking Chemistries................................................................................................... 10-14
10.8.1 Introduction...................................................................................................................... 10-14
10.8.2 Masking/Unmasking Chemistries.................................................................................... 10-15
XI
Contents – Maintenance Volume
XII
Contents – Maintenance Volume
XIII
Contents – Maintenance Volume
XIV
Contents – Maintenance Volume
XV
Contents – Maintenance Volume
XVI
Contents – Maintenance Volume
XVII
Contents – Maintenance Volume
XVIII
15 Diagnostics
15.1 Overview
Diagnostics are a series of tests and actions used to confirm or isolate instrument problems.
The diagnostic tests and actions are tools to detect problems and cannot be used to determine
the specific error. You should use them along with alarm messages and error symptoms of the
instrument.
15.2.1 Introduction
The sample system is responsible for delivering samples to the system for analysis. The
system provides the sample probe level sense test, which helps troubleshooting sample probe
level sense function.
15-1
15 Diagnostics
• An alarm message appears indicating the sample probe contacts no liquid while
dispensing liquid on the reaction carousel, and the analysis is stopped. The sample probe
is confirmed not influenced by air bubbles in reagents or reagent probe level sense error.
• An alarm message related to level sense error appears when the sample probe is
dispensing liquid to the ISE sample injection port, and the analysis is stopped. The ISE
module works normally.
• An alarm message appears indicating that the sample probe contacts no liquid while
dispensing liquid on the sample carousel (in a water test), and the analysis is stopped.
The testing liquid on the position is correct.
• An alarm message appears indicating that the sample probe contacts no liquid in the
wash well, and the analysis is stopped. The error is not related to the fluidics system.
Test procedure
1. Select Utility-Maintenance-Diagnostics.
4. Place a sample cup with its 2/3 full of water, and then select Next. The Sample Probe
The default test position is No.1 of the sample carousel. To change the test position,
select the Change Pos button, type in the new position number, and then select OK.
5. Select Start.
The system starts measuring the working voltage of the sample probe level sense board
and continuously detects the fluid level in the test position for 20 times.
6. When the test is finished, the results are displayed on the screen.
Test results
The test results are explained as follows:
Level Sense Board Voltage Check Results
Pass/Fail: Pass indicates that the working voltage of the sample probe level sense board is
normal; Faile indicates the reverse condition.
Level Sense Test Data
Test result: OK indicates that the connection between the sample probe and the level sense
board, power supply, output voltage, and connection between the sample probe level sense
board and the probe adapter are normal; and Error indicates the reverse condition.
15-2
15 Diagnostics
Corrective action
If the operating voltage of the level detection board is beyond the reference range, contact our
customer service department or your local distributor.
If the result of the level detection performance is abnormal, contact our customer service
department or your local distributor.
15-3
15 Diagnostics
15-4
16 Maintenance
16.1 Overview
16.1.1 Introduction
Maintenance of the system should be performed regularly by trained personnel to ensure
reliable performance and reduce unnecessary service calls. Even you are only an operator, it is
important for you to read this chapter. Your thorough understanding will help you obtain the
best performance of the system.
The Biochemistry Maintenance, ISE Maintenance and Scheduled Maintenance Log are
provided. The Biochemistry Maintenance and ISE Maintenance features provide a list of the
maintenance procedures that can be performed to optimize the system performance. The
Scheduled Maintenance Log feature allows you to understand what maintenance is needed,
when it is performed and who performed the procedure. It is capable of reminding you of the
maintenance that is due and keeping track of what is happened during a maintenance
procedure.
In the case of maintenance that is beyond your capability or not covered in this chapter,
contact our customer service department or your local distributor.
The maintenance frequencies stated in this manual are based on working for 5 hours a day,
that is 5*800=4,000 tests/day, and 5*800*25=100,000 tests/month.
16-1
16 Maintenance
Warning
Do not perform any maintenance procedures that are not described in this chapter; otherwise,
equipment damage or personal injury may be caused.
Do not touch the components other than those specified in this chapter.
Performing unauthorized maintenance procedures can damage the instrument and cause
personal injury, or invalidate the applicable warranty provisions in the service contract.
After performing maintenance, make a verification to ensure that the system runs normally.
Do not spill water or reagent on mechanical or electrical components of the system.
If the system is to be stored for a long time (over 1 week) or transported, contact our customer
service department or your local distributor to perform necessary maintenance in order to
ensure the system’s optimal performance in following use.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
16.1.2 Consumables
Please use the consumables manufactured or recommended by our company in order to
achieve the promised system performance. If needed, contact our customer service department
or your local distributor.
16-2
16 Maintenance
16-3
16 Maintenance
Accompanying Tools
16-4
16 Maintenance
16.2.1 Introduction
The Biochemistry Maintenance feature provides maintenance instructions for the
biochemistry system. The following three types of maintenance are available.
Photometric system:
• Cuvette check
• Lamp check
• Replace lamp
16-5
16 Maintenance
• Replace cuvette
Hydropneumatics:
• Concentrated wash
• Concentrated wash probes/mixers
• Clean/Prime probes/mixers
• Auto clean/prime
• Filter and DI water tank
Sample/Reagent handling system and mixer assembly:
• System reset
• Clean probes/mixers/wash wells
• Clean probes interior
• Replace syringe
• Clean/Replace probes
• Remove air bubbles in syringes
The biochemistry maintenance is described in detail in the following pages.
16-6
16 Maintenance
Maintenance procedures
Provides frequently-used maintenance commands of the biochemistry system. Select a
maintenance command button to start the maintenance procedure.
Online help
Online help information is provided for each biochemistry maintenance command. Select the
icon to the left of a maintenance command to show relevant instructions.
Exit
Select this button to close the Maintenance window.
16.3.1 Introduction
The ISE Maintenance feature provides maintenance commands for the ISE module. The
following maintenance procedures are included:
• Clean electrodes
• Clean electrode tubes
• Clean SIC/drain outlet
• Water prime
• Replace electrode
• Prime buffer solution
• Discharge waste fluid
• ISE module reset
The ISE maintenance is described in detail in the following pages.
16-7
16 Maintenance
Maintenance procedures
Provides frequently-used maintenance commands of the ISE module. Select a maintenance
command button to start the maintenance procedure.
Online help
Online help information is provided for each ISE maintenance command. Select the icon
to the left of a maintenance command to show relevant instructions.
Exit
Select this button to close the Maintenance window.
16.4.1 Introduction
Scheduled maintenance procedures are determined by use of the components and frequency
of performance, and should be performed regularly by trained personnel to ensure reliable
performance and reduce unnecessary service calls. Read this section carefully prior to doing
the maintenance.
The Customize feature allows definition of maintenance procedures and configuration of
manufactured-/user-defined maintenance procedures for each maintenance frequency. The
Electronic Maintenance Log is provided enabling you to record comments and other
16-8
16 Maintenance
16-9
16 Maintenance
16-10
16 Maintenance
16-11
16 Maintenance
16-12
16 Maintenance
16-13
16 Maintenance
Maintenance procedures
Shows the preset and user-defined maintenance procedures for the current maintenance
frequency.
Select field
Choose a maintenance procedure and click on the corresponding Select checkbox. A tick
appears in the middle of the checkbox, which indicates the maintenance procedure is chosen.
Select the function buttons at the bottom of the screen to access a window or execute an
operation. To deselect a maintenance procedure, click on the Select checkbox again. The tick
inside the checkbox disappears, which indicates the maintenance procedure is deselected.
Property field
Shows how the maintenance procedure is defined. The Property includes two options: System
and User. System indicates that the maintenance procedure is defined by the manufacturer and
cannot be configured; User indicates that the maintenance is defined by user and can be
configured for each maintenance frequency.
16-14
16 Maintenance
Operator field
Shows who performs the maintenance procedure, that is, the user ID currently logging on the
system.
Scroll bar
If all maintenance procedures of a period are not shown on the current screen, move the scroll
bar view more maintenance procedures.
OK button
This function allows the reviewal of the selected maintenance procedure and entering of the
date performed. When the approving a maintenance procedure, the date of performance will
be displayed as the current date.
Log button
The electronic maintenance log function allows the recording of comments and other
important information of maintenance. Choose one or more maintenance procedures, and then
select the Log button. The Electronic Maintenance Log window shows. Input logs for the
procedure selected, and then select OK. Your input information will be applied to the selected
maintenance procedure.
History button
This feature provides a stored history record of maintenance performance with date and
operator for the procedure selected. You are allowed to edit or delete a maintenance record.
Please note that only one maintenance procedure can be recalled for history performance at
one time.
16-15
16 Maintenance
Customize button
The Customize function allows definition of new maintenance procedures and configuration
of manufactured-/user-defined maintenance procedures. User-defined maintenance procedures
can be deleted.
Select Customize on the Scheduled Maintenance screen. The Customize Maintenance
window is displayed.
To define a maintenance procedure:
• Select New.
• Enter the name of the new maintenance procedure.
• Select OK. The maintenance procedure is displayed in the Available Maintenance list.
• Use >> and << to configure or cancel user-defined maintenance procedures. The
property of a user-defined maintenance procedure is User.
• Select OK to save the configuration, or select Cancel to abort it.
To configure a maintenance procedure:
• Choose a maintenance frequency in the Schedule pull-down list.
• Choose a maintenance procedure in the Available Maintenance list. Move the vertical
scroll bar to view more maintenance procedures.
16-16
16 Maintenance
• Select >>. The selected maintenance procedure appears in the Enabled Maintenance
list, and the relevant maintenance schedule screen will be refreshed automatically.
To remove a maintenance procedure:
• Choose a maintenance procedure in the Enabled Maintenance list.
• Select <<. The selected maintenance procedure is removed from the Enabled
Maintenance list and appears in the Available Maintenance list. The relevant
maintenance schedule screen will be refreshed automatically.
• Select OK to save the configuration, or select Cancel to abort it.
Delete button
The system allows deleting of maintenance procedures that will no longer be used. Only
user-defined rather than manufacturer-defined maintenance procedures can be deleted.
2. Select Delete.
Close
Select this button to close the Maintenance window.
16.5.1 Introduction
The daily maintenance procedures should be performed everyday prior to measurements. The
maintenance for the biochemistry system is to check the sample probe, reagent probes, mixers,
wash wells, syringes, deionized water connection, waste connection, and concentrated wash
solution volume. The maintenance for the ISE module is to clean the electrodes in order to
remove the proteins and lipid remaining on their surfaces.
16-17
16 Maintenance
Purpose
To check the sample probe and reagent probes for water dripping, stains and liquid flow
abnormities, and check if the mixers can rotate normally.
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
System status
Make sure that the system status is Standby.
Precautions
Warning
The probes and mixers are sharp and vulnerable. To prevent injury and equipment damage,
exercise caution when working around the probes and mixers. Keep away from the probes and
mixers to avoid collision with them.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1. Open the upper protective shield of the analyzer.
2. Check the exterior of the probes/mixers for stains. If yes, perform the Clean Probes
Exterior or Clean Mixers procedure, and then proceed to the next step.
5. Select Continue.
6. Check the liquid flow of the sample probe and reagent probes. If the liquid flow is
sprayed out or does not come out vertically, the probe may be clogged. Perform the
Concentrated Wash Probes/Mixers procedure, and then check them again. If the
abnormity remains, perform the Clean Sample Probe Interior or Clean Probe R1/R2
Interior procedure. If the abnormity still remains, perform the Replace Sample Probe or
Replace Probe R1/R2 procedure, or contact a service engineer.
16-18
16 Maintenance
Figure 16.4 Normal and abnormal liquid flows of sample probe and reagent probes
OK Error
Maintenance-Daily.
11.Select Log, and then record commends and other important information for the
procedure.
Purpose
To check if the wash wells have a normal water flow.
16-19
16 Maintenance
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
System status
Make sure that the system status is Standby.
Precautions
Warning
The probes and mixers are sharp and vulnerable. To prevent injury and equipment damage,
exercise caution when working around the probes and mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1. Open the upper protective shield of the analyzer.
4. Select Continue.
5. Observe the water flow of the probe/mixer wash wells, and check if the water reaches to
about 5mm of the probe/mixer from the tip. If it does, proceed to the next step; otherwise,
perform the Clean Wash Wells procedure.
6. Select Done.
Maintenance-Daily.
8. Mark the Select checkbox in the same row as Check Wash Wells.
10.Select Log, and then record commends and other important information for the
16-20
16 Maintenance
procedure.
Purpose
To check the sample/reagent syringes for leak and air bubbles.
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
Materials required
Clean gauze
System status
Make sure that the system status is Incubation or Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1. Open the front door of the analyzer. You will see three syringes on the right of the
analyzer. They are, from left to right, sample syringe, reagent syringe 1 and reagent
syringe 2.
2. Check the T piece assembly and plunger guide cap for leak.
3. Use dry gauze to wipe the T piece, and then check if the gauze is moistened.
• If it is, tighten the T piece and then perform the Home command on the
Commands screen.
16-21
16 Maintenance
• Check the T piece and plunger guide cap again. If the leak remains, check if the
washer inside the syringe connector is intact.
• If the washer is damaged, replace it with a new one; otherwise, replace the syringe.
4. Check the syringe interior for air bubbles. If yes, perform the following steps:
• Loosen counterclockwise the four retaining screws on top of the syringe, and then
remove the screws and the fixing blocks.
• Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
• Pull the plunger rod until it cannot move and push it quickly. Repeat the pull-push
action until the air bubbles inside the syringe are removed.
• Install the syringe on the bracket, and then tighten the fixing blocks and retaining
screws.
• Tighten clockwise the retaining screw at the bottom of the syringe.
Maintenance-Daily.
9. Select Log, and then record commends and other important information for the
procedure.
Purpose
To check the DI water connection to ensure normal supply of DI water.
16-22
16 Maintenance
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
System status
Make sure that the system status is Incubation or Standby.
How to do
1. Check if the DI water tube is properly connected to the water inlet on the rear panel of
the analyzer.
2. Check that the water tank or other water containers have sufficient deionized water.
Purpose
To check the waste tube connection and the high-concentration waste tank to prevent
overflow.
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
System status
Make sure that the system is powered off, or the system status is Incubation or Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the waste in accordance with your local or national guidelines for biohazard waste
disposal.
16-23
16 Maintenance
How to do
1. Check if the waste drainage system works well, and make sure that the waste tube is not
2. Check that the waste tube is clear and not bent or folded. If it is, the waste may run over
3. If leak remains after performing the above-stated steps, contact our customer service
Purpose
To check the concentrated wash solution volume to prevent measurements from being
terminated.
When to do
You are recommended to do this maintenance procedure everyday before starting the analysis.
System status
Make sure that the system is powered off, or the system status is Incubation or Standby.
Precautions
Warning
Concentrated wash solution is corrosive to human skins. Wear gloves and goggles while
checking the concentrated wash solution. In case your hand or clothes contact the wash
solution, wash them off with soap and water. If the wash solution spills into your eyes, rinse
them with water and consult an oculist.
CAUTION
When the system is Initializing, it may be diluting the concentrated wash solution. Do not try
to fill concentrated wash solution until the system status becomes Standby.
16-24
16 Maintenance
How to do
1. Check the volume of the probe wash solution on the sample carousel and reagent
2. Open the front door of the analyzer and check the concentration wash solution. If
Maintenance-Daily.
7. Mark the Select checkbox in the same row as Check Concentrated/Diluted Wash
Solution.
9. Select Log, and then record commends and other important information for the
procedure.
Purpose
To remove the proteins and lipid remaining on the electrode surfaces.
When to do
You are recommended to perform this procedure after finishing all ISE tests of the day or
16-25
16 Maintenance
Materials required
ISE wash solution, 2ml sample tube
System status
Make sure that the status of both the biochemistry system and ISE module is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
The wash solution may hurt your eyes and skins. Exercise caution while using the wash
solution. If your eyes contact the wash solution, rinse them off with fresh water and consult a
doctor.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
How to do
1. Select Utility-Maintenance-Maintenance- ISE Maintenance.
5. Fill a 2ml sample tube with 200μl ISE wash solution, and then load it to position D4
5. Select Done.
Maintenance-Daily.
7. Mark the Select checkbox in the same row as Clean ISE Electrodes.
16-26
16 Maintenance
procedure.
Purpose
To clean the exterior of the sample probe and reagent probes to prevent cross contamination.
When to do
This procedure should be performed on weekly basis.
Materials required
2 pieces of clean gauze, ethanol, deionized water
System status
Make sure that the system status is Standby.
Precautions
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes. If the probe is bent or damaged, replace it immediately;
otherwise, unreliable results may be obtained.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
16-27
16 Maintenance
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
4. Rotate the probe arm to move the probe to a position convenient for cleaning, and then
use gauze soaked with ethanol to gently wipe the probe exterior. Clean the probe tip until
it becomes clear without stain.
5. Use gauze moistened with deionized water to clear the ethanol on the probe.
6. Select Continue.
Maintenance-Weekly.
10.Mark the Select checkbox to the right of Clean Sample/Reagent Probes Exterior.
11.Select OK to refresh the current date as the performance date.
12.Select Log, and then record commends and other important information for the
procedure.
16-28
16 Maintenance
Purpose
To clean the sample mixers and reagent mixers to prevent cross contamination.
When to do
This procedure should be performed on weekly bases.
Materials required
2 pieces of clean gauze, ethanol, deionized water
System status
Make sure that the system status is Standby.
Precautions
Warning
Exercise caution while working around the mixer. If it is bent or damaged, replace it
immediately; otherwise, unreliable results may be obtained.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Select Continue.
4. Open the upper protective shield of the analyzer, and then rotate the reagent mixer arm to
5. Open the back protective shield of the analyzer, and then rotate the reagent mixer arm to
6. Use clean gauze soaked with ethanol to wipe the surface of each mixer until the mixer is
clean.
7. Install the mixers by inserting them from the top of the arm. Rotate each mixer to make it
16-29
16 Maintenance
8. Select Continue.
9. Select Done. The system resets the mixers automatically. Check that all mixers are
installed correctly.
Maintenance-Weekly.
procedure.
Purpose
To eliminate cross contamination among the sample probe, reagent probes, mixers, cuvettes
and wash station, and prevent waste from leaving in the waste tubes.
When to do
You are recommended to perform this procedure on weekly basis or when the equipment is to
be stored for a long time.
Materials required
Concentrated wash solution manufactured by our company
System status
Make sure that the system status is Standby.
16-30
16 Maintenance
How to do
1. Open the upper protective shield of the analyzer.
2. Place 62ml concentrated wash solution in position D1 and D2 of the reagent carousel and
5. Confirm if cuvette check is needed after the diluted wash. If it is, mark the checkbox in
7. The system starts cleaning the sample probe, reagent probes, mixers, cuvettes and wash
8. Perform the cuvette check procedure. Refer to 16.6.4 Cuvette Check (page 16-32) for
details.
9. Select Done.
Maintenance-Weekly.
procedure.
16-31
16 Maintenance
Purpose
To check if the reaction cuvettes are polluted and the light transmittance is decreased in order
to prevent unreliable test results.
When to do
You are recommended to perform this procedure on weekly basis or after replacing/cleaning
the reaction cuvettes.
System status
Prior to performing the maintenance, make sure that the system has been power on for over 10
minutes and the system status is Standby. Check if the reaction carousel has a cuvette for each
position. If not, load cuvettes.
Precautions
NOTE
When a cuvette is deemed dirty, clean or replace it immediately, and then perform the cuvette
check again.
Stains inside cuvettes will influence the photometric measurement. You are recommended to
perform the Cuvette Check after finishing the Concentrated Wash procedure.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
16-32
16 Maintenance
3. Make sure that the lamp has been turned on for over 10 minutes. Select Continue and
then select Start. When finishing the check, the system refreshes the cuvette status based
on the check results. Record the cuvettes highlighted in red and perform the Clean
Cuvettes procedure. Refer to 16.11.10 Clean Cuvettes (page 16-80) for details. To abort
the cuvette check, select Stop.
The screen shows all cuvettes and highlights the dirty cuvettes with special color:
16-33
16 Maintenance
4. Select Result. The Cuvette Check Results window appears and shows the latest
16-34
16 Maintenance
5. Choose a cuvette in the result list. The Cuvette Status window pops up.
Maintenance-Weekly.
10.Select Log, and then record commends and other important information for the
16-35
16 Maintenance
procedure.
Purpose
To check the light intensity by measuring absorbance of 5 cuvettes and help you determine
whether to replace the lamp.
When to do
You are recommended to perform this procedure on weekly basis or after replacing the lamp.
System status
Prior to performing the maintenance, make sure that the system has been power on for over 10
minutes and the system status is Standby.
Precautions
NOTE
Before checking the lamp, perform the Cuvette Check procedure and replace or clean the dirty
cuvettes; otherwise, the lamp check results are unreliable.
To ensure the photometer’s measurement performance, replace the lamp in the case of weak
light intensity.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
16-36
16 Maintenance
3. Make sure that the lamp has been turned on for over 10 minutes. Select Continue and
then select Start. When finishing the check, the system displays the results and refreshes
the lamp status. To abort the lamp check, select Stop.
16-37
16 Maintenance
On the left of the screen shows the absorbance at each wavelength in the current lamp
check; on the right of the screen shows that of the previous lamp check. By checking the
results of the previous and current lamp check, you may understand the status of the
lamp.
4. If the Current Status field shows Normal, it indicates that the lamp’s light intensity
satisfies the requirements of measurement; if it shows Weak in red, it indicates that the
lamp has insufficient light intensity.
• If the alarm indicates the lamp is off, check if the lamp has been turn on. If not,
manually turn on the lamp; if yes, contact our customer service department or your
local distributor.
• If the alarm indicates light intensity too strong, contact our customer service
department or your local distributor.
• If the alarm indicates light intensity weak, select Replace to replace the lamp. For
more information, refer to 16.10.1 Replace Lamp (page 16-58).
• Print: to print the lamp check results currently available on the screen.
• Exit: to close the window.
Maintenance-Weekly.
procedure.
16-38
16 Maintenance
Purpose
To remove the stains from the tubes.
When to do
Clean the electrode tubes with the following frequency based on the number of
measurements:
• If less than 100 samples are analyzed every month, perform the procedure every 2 weeks.
• If no less than 100 samples are analyzed every month, perform the procedure every
week.
• If no less than 500 samples are analyzed every month, perform the procedure every 3
days.
Materials required
ISE wash solution, pipette, Philips-head screwdriver, and spacer
System status
Make sure that the status of the ISE module is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
The wash solution may hurt your eyes and skins. Exercise caution while using the wash
solution. If your eyes contact the wash solution, rinse them off with fresh water and consult a
doctor.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
How to do
1. Select Utility-Maintenance-Maintenance- ISE Maintenance.
16-39
16 Maintenance
4. Open the cover of the ISE module on the analyzer’s front panel.
7. Remove the spacer cap and use the pipette to dispense 5ml wash solution into the spacer.
10.When the cleaning is finished, remove the spacer and reinstall the Na, K, Cl and
Reference electrodes.
Maintenance-Two Week.
15.Mark the Select checkbox in the same row as Clean ISE Tubes.
16.Select OK to refresh the current date as the performance date.
17.Select Log, and then record commends and other important information for the
procedure.
16-40
16 Maintenance
Purpose
To remove the waste and dust from the 5 wash wells (probe R1, probe R2, sample probe,
sample mixers and reagent mixers).
When to do
This procedure should be performed on monthly basis.
Materials required
Cotton swabs and sodium hypochlorite solution (NaClO)
System status
Make sure that the system status is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
4. Select Continue.
5. Rotate the same probe, reagent probes and mixers to keep them away from the wash
wells.
6. Use clean cotton swabs moistened with NaClO to clean the wash wells.
16-41
16 Maintenance
7. Select Continue. The system starts cleaning the probes and mixers.
9. Select Done. The system resets the probes and mixers automatically.
Maintenance-Monthly.
11.Mark the Select checkbox in the same row as Clean Wash Wells.
12.Select OK to refresh the current date as the performance date.
13.Select Log, and then record commends and other important information for the
procedure.
Purpose
Clean the rotors of the probes and mixers to minimize noise and fraying due to movement.
When to do
This procedure should be performed on monthly basis.
Materials required
Clean gauze
System status
Make sure that the system status is Standby.
16-42
16 Maintenance
Precautions
Warning
The probe and mixer tip are sharp and may cause puncture wounds. To prevent injury,
exercise caution when working around the probes and mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
4. Select Continue.
5. Use clean gauze to wipe the rotors while pulling them up and down.
6. Select Done. The system resets the probes and mixers automatically.
Maintenance-Monthly.
10.Select Log, and then record commends and other important information for the
procedure.
16-43
16 Maintenance
Purpose
To clean the cuvette wash station in order to avoid waste buildup and cross contamination.
When to do
This procedure should be performed on monthly basis.
Materials required
Gauze, ethanol, deionized water, waste container (large beaker)
System status
Make sure that the system status is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1. Open the back protective shield of the analyzer.
2. Remove the cuvette wash station and use ethanol-moistened gauze to wipe the wash
probes.
3. Use gauze moistened with deionized water to clear the ethanol on the wash probes.
6. Choose Auto Clean and Prime. The maintenance guide window shows. Select
Continue.
16-44
16 Maintenance
Maintenance-Monthly.
10.Mark the Select checkbox in the same row as Clean Cuvette Wash Station.
11.Select OK to refresh the current date as the performance date.
12.Select Log, and then record commends and other important information for the
procedure.
Purpose
To clean the filter core in order to prevent accumulation of foreign matters and improve the
water quality.
When to do
This procedure should be performed on monthly basis.
Materials required
Tube brush or ultrasound cleaner
System status
Make sure that the system status is Standby.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Open the front door of the analyzer. The DI water filter appears in front of you.
16-45
16 Maintenance
5. Press the filter, loosen the filter cap and remove the filter core. Use a tube brush to clean
Press the
filter Loosen the
filter cap
Filte
Remove
the filter
core
6. Remove the filter core on the inlet tube of the water tank. Use a tube brush to clean the
16-46
16 Maintenance
Remove the 2
tubes
Filter
core
Filter in the
inlet tube
Water tank
filter
7. Restore the filter core according to the above-mentioned steps in reversed order.
8. Select Continue. The system starts priming the tubes with deionized water.
Maintenance-Monthly.
11.Mark the Select checkbox in the same row as Clean Filter Core.
16-47
16 Maintenance
procedure.
Purpose
To clean the dust screens to ensure good ventilation.
When to do
This procedure should be performed on monthly basis.
Materials required
Suction cleaner, hair brush and fresh water
System status
Make sure that the analyzer main power is off.
16-48
16 Maintenance
Precautions
NOTE
Use a suction cleaner to clean the dust screens while keeping them uninstalled, or use a hair
brush and fresh water to clean the dust screens after removing them from the analyzer.
Do not reinstall the dust screens until they are dry completely.
Install the dust screens correctly to avoid gaps.
To clean the dust screens by knocking them at solid ground, find an appropriate place, hold
the dust screens by the strengthening rib, and then carefully knock them at the ground. See the
figure below:
Strengthening rib
How to do
1. Switch off the analyzer’s main power.
2. Open the front door of the analyzer and remove the dust screens.
16-49
16 Maintenance
Dust screens
Upwards
Upwards
Inwards
Inwards
Upwards
Outwards
3. Use the suction cleaner, or hair brush and fresh water to clean the dust screens, and then
Maintenance-Monthly.
9. Mark the Select checkbox in the same row as Clean Dust Screens.
16-50
16 Maintenance
procedure.
Purpose
To replace the syringe plunger assembly to ensure optimal measuring performance.
When to do
Perform this procedure when the syringe is due, or has leak or other abnormal phenomena.
Materials required
Deionized water, beaker, and syringe plunger assembly
System status
Make sure that the system status is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Prepare a new syringe plunger assembly and washer, put the plunger head in the
deionized water beaker to remove air from the syringe, and then moisten the washer in
the deionized water.
16-51
16 Maintenance
3. Choose Replace Syringe. The maintenance guide window pops up. Choose a syringe to
4. Open the front door of the analyzer. You will see three syringes on the right of the
analyzer. They are, from left to right, sample syringe, reagent syringe 1 and reagent
syringe 2. See the figure below.
T piece
Fixing block
7.5 scales 15 scales
Retaining screw
Plunger
guide cap
Retaining
screw
5. Loosen counterclockwise the four retaining screws on top of the syringe, and then
6. Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
7. Hold the T piece with one hand and the syringe connector with the other hand. Loosen
8. Loosen the plunger guide cap counterclockwise, hold the plunger head and pull it
9. Insert the plunger head of the new plunger assembly into the bottom of the syringe, and
16-52
16 Maintenance
10.Soak the new syringe connector in the deionized water beak, pull the plunger head to
aspirate half syringe of deionized water, and then push the plunger head to remove the
air.
11.If there is no washer inside the T piece, put the new washer in the T piece. Hold the T
piece with one hand and the syringe connector with the other hand, and then screw the T
piece clockwise.
14.Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
15.Pinch the plunger guide cap to adjust the syringe height. For the sample syringe, make
the syringe head over the upper fixing block for 7.5 scales; for the reagent syringes,
make the syringe head over the upper fixing block for 15 scales.
Maintenance-Three-Month.
Plunger Assemblies.
16-53
16 Maintenance
procedure.
Purpose
To clean the deionized water tank to ensure good cleaning performance of the system.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
Water container
System status
Make sure that the system status is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Open the front door of the analyzer. You will see the deionized water tank as shown in
16-54
16 Maintenance
DI water tank
4. Remove the quick connector from the outlet of the water tank, and then pull the water
5. Put a water container below the outlet of the DI water tank; insert another normally open
quick connector into the outlet to drain water into the water container. When the DI
water tank is emptied, proceed to the next step. Or you may close the outlet with a solid
plug, take out the water tank completely, and then empty it by inclining it. Choose this
method if there is little water inside the DI water tank.
6. Remove the tubes from the tank inlet, disconnect the liquid level floater signal cable
from the right panel of the water tank, take out the water tank completely, and then
remove the liquid level floater. Perform this step according to the figure below.
16-55
16 Maintenance
Outlet connector.
Press to drain water
8. Insert the floater into the connector on rear panel of the water tank, connect the backflow
tube to the water tank, connect the floater signal cable and water supply tube to the water
tank according to the labels on it, and then place the water tank in the cabinet of the
analyzer.
9. Select Continue. The system automatically primes the deionized water tubes.
10.Take away the water container and close the front door of the analyzer.
11.Select Utility-Maintenance-Maintenance, and then select Scheduled
16-56
16 Maintenance
Maintenance-Three-Month.
12.Mark the Select checkbox in the same row as Clean DI Water Tank.
13.Select OK to refresh the current date as the performance date.
14.Select Log, and then record commends and other important information for the
procedure.
Purpose
To replace the filter core and ensure good filtering effects.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
2 new filter cores
System status
Make sure that the system status is Standby.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Remove the deionized water filter core and water tank filter core according to the Clean
4. Put the new filter core in the filter and reinstall the filter.
5. Select Continue. The system starts priming the deionized water tubes.
16-57
16 Maintenance
Maintenance-Three-Month.
8. Mark the Select checkbox in the same row as Replace Filter Core.
10.Select Log, and then record commends and other important information for the
procedure.
Purpose
To ensure that the lamp works normally.
When to do
You are recommended to perform this procedure every 6 months or when you find that the
lamp does not satisfy the requirements after performing the Lamp Check.
Materials required
New lamp, Philips-head screwdriver, cotton or antistatic gloves
System status
Make sure that the system status is Standby or Failure.
16-58
16 Maintenance
Precautions
NOTE
Too hot lamp may burn you. Do not replace the lamp until it gets cool.
Do not touch the light entrance on the lamp housing or the lens in front of the lamp. In case
the light entrance is dirty, use cotton swabs moistened with absolute ethanol to clean it.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
2. Choose Replace Lamp. The maintenance guide window pops up. Select Continue.
3. Make sure that the lamp has cooled down for 5 minutes, and then select Continue.
4. Remove the cover plate of the lamp on the front panel of the analyzer.
5. Wear a pair of cotton or antistatic gloves, loosen the nuts on the cable terminals, and then
16-59
16 Maintenance
8. Hold the new lamp on its handle with its flat side facing the reaction disk and insert the
lamp into the lamp housing. Make sure that the screw holes on the lamp base are aligned
to the counterparts on the lamp housing.
NOTE
After inserting the lamp into the lamp housing and tightening the retaining screws, check
if there is space between the lamp base and the lamp housing. If there is, reinstall the
lamp according to step 6 to 8.
9. Install the retaining screw, O-ring connectors, cable terminal nuts and lamp cover plate
16-60
16 Maintenance
10.Select Continue.
11.When the lamp is incubated, select Done.
Perform the Lamp Check procedure to ensure the new lamp works well. For more
information, refer to 16.6.5 Lamp Check (page 16-36).
Maintenance-Six-Month.
procedure.
Purpose
To replace the water inlet filter to ensure the good filtering effects.
When to do
You are recommended to perform this procedure every 6 months.
Materials required
New water inlet filter
System status
Make sure that the system is powered off, or the system status is Incubation or Standby.
How to do
1. Check that the system is powered off, or the system status is Incubation or Standby.
16-61
16 Maintenance
2. Turn off the power switch of the water unit or other water supply equipment.
3. Place a water container below the water inlet filter, and then loosen the air vent on the
4. Loosen the two tube clamps on the two ends of the old filter, remove the inlet tube, and
5. Connect the new filter with the inlet tube and then tighten the tube clamps.
6. Turn on the power switch of the water unit or other water supply equipment. Observe the
new filter for over 1 minute and make sure that no leaks occur.
Maintenance-Six-Month.
8. Mark the Select checkbox in the same row as Replace Water Inlet Filter.
10.Select Log, and then record commends and other important information for the
procedure.
Purpose
To clean the analyzer panels, carousel covers, touchscreen and keyboard.
16-62
16 Maintenance
When to do
Perform this procedure when dust or other stains are found on the components.
Materials required
Clean gauze, neutral wash solution, and deionized water
System status
Make sure that the system status is not Running.
Precautions
Warning
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1. Make sure that the system is not running tests, and then open the protective shield.
2. Use clean gauze moistened with ethanol to clean the analyzer panels and carousel covers.
Purpose
To clean the sample carousel assembly to ensure clear operating environment and eliminate
the risks of cross contamination.
When to do
Perform this procedure when samples are spilled into the sample compartment or dust is
found inside of it.
16-63
16 Maintenance
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Make sure that the system status is Stopped or Standby.
Precautions
Warning
Do not spill water or ethanol into the sample compartment to prevent equipment damage.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
Dispose of the used gauze in accordance with your local or national guidelines for biohazard
waste disposal.
How to do
1. Make sure that the system is in Stopped or Standby status.
2. Remove the sample carousel cover and sample carousel, and then store them properly.
3. Use clean gauze soaked with deionized water or ethanol to clean the interior of the
sample compartment and exterior of the sample refrigeration chamber. If necessary, you
can use gauze moistened with neutral wash solution.
4. Use clean gauze to clean the bar code reader window inside the sample compartment. If
necessary, you can use gauze soaked with ethanol or deionized water. Make sure that
there is no trace or dust left on the glass.
5. Use clean gauze soaked with deionized water or ethanol to clean the reagent carousel,
and then use cotton swabs dipped with ethanol to clean the reagent positions.
16-64
16 Maintenance
Purpose
To clean the interior of the sample probe and avoid clogging.
When to do
Perform this procedure when you find that the sample probe is clogged and cannot aspirate or
dispense sample, or when the sample probe is detected with abnormal liquid flow through the
Check Probes/Mixers maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head screwdriver, beaker,
deionized water, and thread syringe
System status
Make sure that the system status is Standby or Failure.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Recall the maintenance logs and check if the sample probe has been removed and
reinstalled for 3 times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.
3. Choose Clean/Replace Probe. The maintenance guide window pops up. Select
Continue.
4. Grab the lower parts of the arm cover and pull them slightly from the opposite directions;
remove the cover from the arm base.
5. Press the circuit board with one hand and unplug the tube connector with the other hand,
and then use a small slot-head screwdriver to loosen the earthing wire on the sample
probe.
16-65
16 Maintenance
6. Use a small screwdriver to remove the retaining screw from the sample probe and take
7. While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is disconnected.
Remove the tube from the sample probe.
Exercise caution to prevent the washer from dropping out. If the washer drops out, store
it in a clear place for later installation. To replace the washer, take it out from the tube
connector.
16-66
16 Maintenance
Liquid level
detection board
connector
Retaining
Earthing wire screw
and
spring
Keep the
washer steady Washer
9. Connect the unclogging device to the sample probe, fill the syringe with deionized water
and then connect it to the unclogging device. Put the sample probe inside the beaker
while keeping the probe tip not contacting the beaker. Push the syringe to rinse the
interior of the sample probe. Repeat this step for 10 times.
If the syringe plunger leaks and the sample probe cannot be unclogged due to serious
blockage, replace the sample probe.
10.When continuous water flow comes out of the sample probe in the same direction with
the probe, it indicates the cleaning procedure is finished successfully. Remove the
unclogging device.
11.Insert the sample probe downwards into the hole on the probe arm while aligning the
16-67
16 Maintenance
screw hole on the probe plate to the rod inside the arm.
12.To replace the washer, remove the old one from the tube connector and install the new
one. Connect the tube connector to the sample probe and then tighten it.
13.Fix the earthing wire of the sample probe to the earthing terminal inside the arm;
14.Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the spring
direction and make the thread opening face downwards.
15.Pinch the sample probe by the part near the probe arm. Push the sample probe upwards
and then release it to check if the spring works well.
16.Select Continue. When the analyzer is powered on, check if the No.D2 LED indicator
on the circuit board inside the probe arm is lit.
17.Install the probe arm cover properly until you hear a click.
18.Pinch the sample probe by the part near the probe arm. Push the sample probe upwards
and then release it to check if the spring works well.
19.Select Done. The system resets the sample probe automatically. Check if the water flow
coming out of the sample probe is continuous and in the same direction as the probe. If it
is not, perform the Check Probes/Mixers procedure to troubleshoot the problems.
Maintenance-Other.
21.Mark the Select checkbox to the right of Clean Sample Probe Interior.
16-68
16 Maintenance
procedure.
Purpose
To clean the interior of the reagent probes and avoid clogging.
When to do
Perform this procedure when you find that a reagent probe is clogged and cannot aspirate or
dispense sample, or when a reagent probe is detected with abnormal liquid flow through the
Check Probes/Mixers maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head screwdriver, beaker,
deionized water, and thread syringe
System status
Make sure that the system status is Standby or Failure.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Recall the maintenance logs and check if the reagent probe has been removed and
reinstalled for 3 times. If it has, prepare a new washer and moisten it with deionized
water. Store the washer properly to avoid being lost.
16-69
16 Maintenance
3. Choose Clean/Replace Probe. The maintenance guide window pops up. Select
Continue.
4. Clean the reagent probe by referring to step 4 to 19 in 16.11.3 Clean Sample Probe
Interior.
Maintenance-Other.
6. Mark the Select checkbox to the right of Clean Probe R1/R2 Interior.
8. Select Log, and then record commends and other important information for the
procedure.
Purpose
To replace the sample probe.
When to do
Perform this procedure when the sample probe is damaged and cannot be repaired due to the
following causes, such as serious blockage, or bending.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new sample probe
System status
Make sure that the system status is Standby or Failure.
16-70
16 Maintenance
Precautions
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Prepare the new sample probe. Recall the maintenance logs and check if the sample
probe has been removed and reinstalled for 3 times. If it has, prepare a new washer and
moisten it with deionized water. Store the washer properly to avoid being lost.
3. Choose Clean/Replace Probe. The maintenance guide window pops up. Select
Continue.
4. Grab the lower parts of the arm cover and pull them slightly from the opposite directions;
remove the cover from the arm base.
5. Press the circuit board with one hand and unplug the tube connector with the other hand,
and then use a small slot-head screwdriver to loosen the earthing wire on the sample
probe.
6. Use a small screwdriver to remove the retaining screw from the sample probe and take
7. While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is disconnected.
Remove the tube from the sample probe.
Exercise caution to prevent the washer from dropping out. If the washer drops out, store
it in a clear place for later installation. To replace the washer, take it out from the tube
connector.
16-71
16 Maintenance
Liquid level
detection board
connector
Retaining
Earthing wire screw
and
spring
Keep the
washer steady Washer
9. Insert the sample probe downwards into the hole on the probe arm while aligning the
screw hole on the probe plate to the rod inside the arm.
10.To replace the washer, remove the old one from the tube connector and install the new
one. Connect the tube connector to the sample probe and then tighten it.
11.Fix the earthing wire of the sample probe to the earthing terminal inside the arm;
12.Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the spring
direction and make the thread opening face downwards.
13.Pinch the sample probe by the part near the probe arm. Push the sample probe upwards
16-72
16 Maintenance
14.Select Continue. When the analyzer is powered on, check if the No.D2 LED indicator
on the circuit board inside the probe arm is lit.
15.Install the probe arm cover properly until you hear a click.
16.Select Done. The system resets the sample probe automatically. Check if the water flow
coming out of the sample probe is continuous and in the same direction as the probe. If it
is not, perform the Check Probes/Mixers procedure to troubleshoot the problems.
Maintenance-Other.
18.Mark the Select checkbox in the same row as Replace Sample Probe.
19.Select OK to refresh the current date as the performance date.
20.Select Log, and then record commends and other important information for the
procedure.
Purpose
To replace the probe R1/R2.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new reagent probes
16-73
16 Maintenance
System status
Make sure that the system status is Standby or Failure.
Precautions
Warning
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Prepare the new reagent probe. Recall the maintenance logs and check if the reagent
probe has been removed and reinstalled for 3 times. If it has, prepare a new washer and
moisten it with deionized water. Store the washer properly to avoid being lost.
3. Choose Clean/Replace Probe. The maintenance guide window pops up. Select
Continue.
4. Replace the reagent probe by referring to step 4 to 19 in 16.11.5 Replace Sample Probe
(page 16-70).
Maintenance-Other.
8. Select Log, and then record commends and other important information for the
procedure.
16-74
16 Maintenance
Purpose
Replace the sample mixers.
When to do
Perform this procedure when the sample mixers are damaged and cannot be repaired.
Materials required
Ethanol, clean gauze, new sample mixers
System status
Make sure that the system status is Standby or Failure.
Precautions
Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
2. Choose Probe/Mixer/Wash Well. The maintenance guide window pops up. Select
Continue.
The mixers return to the wash position and the mixer motors are powered off.
5. Prepare new mixers, and then use clean gauze soaked with ethanol to clean the surface of
each mixer.
6. Install the new mixers from the top of the mixer arms. Rotate each mixer to make it
16-75
16 Maintenance
8. Select Continue.
Maintenance-Other.
11.Mark the Select checkbox in the same row as Replace Sample Mixers.
12.Select OK to refresh the current date as the performance date.
13.Select Log, and then record commends and other important information for the
procedure.
Purpose
Replace the reagent mixers.
When to do
Perform this procedure when the reagent mixers are damaged and cannot be repaired.
Materials required
Ethanol, clean gauze, new reagent mixers
System status
Make sure that the system status is Standby or Failure.
16-76
16 Maintenance
Precautions
Warning
The mixer tips are sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the mixers.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
2. Choose Probe/Mixer/Wash Well. The maintenance guide window pops up. Select
Continue.
The mixers return to the wash position and the mixer motors are powered off.
5. Prepare new mixers, and then use clean gauze soaked with ethanol to clean the surface of
each mixer.
6. Install the new mixers from the top of the mixer arms. Rotate each mixer to make it
8. Select Continue.
Maintenance-Other.
11.Mark the Select checkbox in the same row as Replace Reagent Mixers.
12.Select OK to refresh the current date as the performance date.
16-77
16 Maintenance
13.Select Log, and then record commends and other important information for the
procedure.
When to do
Perform this procedure when you find air bubbles inside the syringes.
Materials required
Concentrated wash solution
System status
Make sure that the system status is Standby.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
4. Select Continue.
5. Loosen counterclockwise the four retaining screws on top of the syringe, and then
6. Loosen counterclockwise the retaining screw at the bottom of the syringe and then
remove it.
7. Hold the T piece with one hand and the syringe connector with the other hand. Loosen
16-78
16 Maintenance
8. Soak the syringe connector in the deionized water beak, pull the plunger head to aspirate
half syringe of deionized water, and then push the plunger head to remove the air.
9. Put the washer in the T piece. Hold the T piece with one hand and the syringe connector
with the other hand, and then screw the T piece clockwise.
12.Align the plunger head to the retaining screw at the bottom of the syringe, and then
tighten clockwise the retaining screw.
13.Pinch the plunger guide cap to adjust the syringe height. For the sample syringe, make
the syringe head over the upper fixing block for 7.5 scales; for the reagent syringes,
make the syringe head over the upper fixing block for 15 scales.
Maintenance-Other.
18.Mark the Select checkbox in the same row as Remove Air Bubbles.
19.Select OK to refresh the current date as the performance date.
20.Select Log, and then record commends and other important information for the
procedure.
16-79
16 Maintenance
Purpose
Use diluted concentrated wash solution and deionized water to soak and clean the reaction
cuvettes.
When to do
Perform this procedure when one of the following situations occurs:
• Overflow is detected on the wash station, or certain cuvettes are deemed dirty after the
Diluted Wash procedure is executed.
• The power is interrupted during measurement and cannot be restored for the moment.
Clean the cuvettes to prevent the residual liquid inside of them from crystallizing.
Materials required
Fiber-free gloves, concentrated wash solution manufactured by our company, dry cloth or
gauze, absolute ethanol, large-opening bottle, deionized water, and reaction cuvettes
System status
Make sure that the system status is Standby.
Precautions
Warning
While removing or installing the reaction cuvettes, exercise caution to avoid scratching them.
Do not touch the optical surface of the reaction cuvettes. If the optical surface is polluted, the
obtained absorbance may be inaccurate.
Wear gloves free of fiber and powder to avoid polluting the optical surface of the reaction
cuvettes.
Do not use fiber tools like cotton swabs, cotton and cotton cloth to wipe the reaction cuvettes.
If fibers are left on the optical surface, inaccurate absorbance may be obtained.
When soaking the reaction cuvettes, immerse them completely into the wash solution. Make
sure that no air bubbles exist inside the reaction cuvette; otherwise, the cleaning effects may
be influenced.
While installing the reaction cuvettes, make sure that the optical surface is confronted with the
outside of the reaction carousel.
Soak the reaction cuvettes with the specified diluted wash solution for the given period;
otherwise the cuvettes may be damaged.
16-80
16 Maintenance
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
NOTE
If a cuvette cannot be removed from the reaction carousel, remove 1 or 2 cuvettes to the right
of the cuvette, use a knife to remove the metal plate next to it, and then use your hands or
tweezers to take out the cuvette.
When serious problems occur such as overflow and require the reaction cuvettes to be
maintained, contact our customer service department or your local distributor.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Select Continue.
4. Remove the reagent mixers and sample mixers over the reaction carousel, and then
16-81
16 Maintenance
The input range is 1-165. Only one position number can be entered each time.
6. Select Replace.
7. The specified cuvette is carried to the front side of the analyzer, that is, the groove of the
heat chamber. Wear a pair of gloves and remove the specified cuvette by pulling it
outwards.
8. If there is obvious buildup of reagent on the exterior of the cuvette, use absolute ethanol
16-82
16 Maintenance
to clean the exterior, and then soak the cuvette in a large-opening bottle filled with 2%
concentrated wash solution, which is diluted at the ratio of 1:50. Cap the large-opening
bottle and store it at room temperature for 2 hours.
9. Take out the soaked cuvette from the bottle, use deionized water to clean the inside and
outside of the cuvette, and then dry the outside of the cuvette with clean, dry gauze or
cloth.
10.Reinstall the cuvette on the reaction carousel and make sure that the cuvette bottom
attaches completely to the reaction cuvette.
Purpose
To ensure that the cuvettes are normal and not contaminated, scratched or damaged.
When to do
Replacing cuvettes is performed as needed or as required. Replace a cuvette if,
• it is detected abnormal through the Cuvette Check procedure; or
• it still cannot be used after being cleaned through the Clean Cuvettes procedure; or
• scratches or cracks are found on the optical surface of the cuvette.
Materials required
Fiber-free gloves, dry cloth or gauze, reaction cuvettes, and concentrated wash solution
manufactured by our company
System status
Make sure that the system status is Standby.
16-83
16 Maintenance
Precautions
Warning
While installing the reaction cuvettes, exercise caution to avoid scratching them. Do not touch
the optical surface of the reaction cuvettes. If the optical surface is polluted, the obtained
absorbance may be inaccurate.
While installing the reaction cuvettes, make sure that the optical surface is confronted with the
outside of the reaction carousel.
Wear gloves free of fiber and powder to avoid polluting the optical surface of the reaction
cuvettes.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
NOTE
If a cuvette cannot be removed from the reaction carousel, remove 1 or 2 cuvettes to the right
of the cuvette, use a knife to remove the metal plate next to it, and then use your hands or
tweezers to take out the cuvette.
When serious problems occur such as overflow and require the reaction cuvettes to be
maintained, contact our customer service department or your local distributor.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
16-84
16 Maintenance
3. Select Continue.
4. Remove the reagent mixers and sample mixers over the reaction carousel, and then
16-85
16 Maintenance
The input range is 1-165. Only one position number can be entered each time.
6. Select Replace.
7. The specified cuvette is carried to the front side of the analyzer, that is, the groove of the
heat chamber. Wear a pair of gloves and remove the specified cuvette by pulling it
outwards.
8. Install the new cuvette to the reaction carousel and make sure that the cuvette bottom can
no longer proceed.
9. Use a pipette to fill 400μl-600μl concentrated wash solution in the new cuvette.
10.Repeat steps 5-9 to replace all cuvettes that need to be replaced, and then select Done.
11.Restore the reaction carousel cover and the sample/reagent mixers.
12.Perform the Cuvette Check procedure to check if the new cuvettes meet the
requirements.
Maintenance-Other.
16-86
16 Maintenance
procedure.
When to do
Perform this procedure when the probes or mixers are clogged or the carryover result exceeds
the limit.
Materials required
Concentrated wash solution
System status
Make sure that the system status is Standby.
How to do
1. Select Utility-Maintenance-Maintenance- Biochemistry Maintenance.
3. Check that No.70 of the reagent carousel outer ring, No.50 of the reagent carousel inner
ring and D3 on the analyzer panel are holding concentrated wash solution. If they are not,
load concentrated wash solution.
Maintenance-Other.
16-87
16 Maintenance
7. Mark the Select checkbox in the same row as Diluted Wash Probes/Mixers.
9. Select Log, and then record commends and other important information for the
procedure.
Purpose
To remove the stains accumulating in the sample injection cup and drain outlet.
When to do
You are recommended to perform this procedure every month.
Materials required
Deionized water, pipette, cotton swabs, and Philips-head screwdriver
System status
Make sure that the status of the ISE module is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
The wash solution may hurt your eyes and skins. Exercise caution while using the wash
solution. If your eyes contact the wash solution, rinse them off with fresh water and consult a
doctor.
CAUTION
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
16-88
16 Maintenance
How to do
1. Select Utility-Maintenance-Maintenance- ISE Maintenance.
3. Select Continue.
5. Open the cover of the ISE module on the analyzer’s front panel.
6. Loosen the screws on the sample injection cup and remove the sample probe guide
block.
7. Use a pipette to fill about 1ml deionized water in the sample injection cup while keeping
8. Wait for 5 minutes to ensure that the crystals on the sample injection port are dissolved.
During the waiting process, proceed to the next step to clean the drain outlet of the ISE
module.
9. Use cotton swabs to clear the stains on the drain outlet. Exercise caution to avoid
10.Check that the crystals on the sample injection port are dissolved and select Continue.
The deionized water inside the sample injection cup is drained.
16-89
16 Maintenance
NOTE
After cleaning the sample injection cup and drain outlet, calibrate the ISE module before
starting measurements.
Maintenance-Other.
18.Mark the Select checkbox in the same row as Clean SIC/Drain Outlet.
19.Select OK to refresh the current date as the performance date.
20.Select Log, and then record commends and other important information for the
procedure.
Purpose
To replace the ISE electrodes to ensure the optimal measurement performance.
When to do
Replace the electrodes when they finish 20,000 tests (in about 3 months).
Materials required
10ml serum, 30ml buffer solution, 2ml or 3ml disposable pipette, preprocessed ISE electrode,
and Philips-head screwdriver
System status
Make sure that the status of the ISE module is Standby.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
16-90
16 Maintenance
CAUTION
Install the electrodes in the correct order.
Before putting an electrode in the electrode case, do not remove the cap on the electrode
connector to prevent liquid ingression. 3 electrodes can be put simultaneously in an electrode
case for processing.
Each electrode contains inner solution inside of it, which decreases little by little as time goes
by. If you find no inner solution by shaking an electrode, measure the weight of the electrode.
The electrode which weighs less than 9g must not be used.
The Cl electrode is sensitive to vibrations. Handle it carefully during the maintenance.
Preparing electrodes
On the day before the current day that the Na, K, Cl and Reference electrodes are to be
replaced, prepare them by performing the following steps.
1. Take out each electrode from the package. If the electrodes get wet, wipe away the water
2. Remove the sponge from the electrode case and put the electrodes in it for aging.
3. Fill 0.5ml serum into the flow cell, and make sure that the serum penetrates through the
flow cell.
4. Add about 25ml buffer solution to the electrode case until the electrodes get soaked
5. Clean the electrodes with deionized water and dry them for later use.
6. Take out the reference electrode from the reference electrode case.
7. Use deionized water to remove the high-concentrated saline from the electrode surface
If the measuring data are unstable after the electrodes are preprocessed for quite a long
time, perform the Clean Electrodes procedure. For more information, refer to 16.5.8
Clean Electrodes (page 16-25).
Replace electrode
1. Select Utility-Maintenance-Maintenance- ISE Maintenance.
2. Choose Replace Electrode. The maintenance guide window shows. Select Continue.
16-91
16 Maintenance
5. Open the cover of the ISE module on the analyzer’s front panel.
6. Loosen the screws fixing the stainless steel plate and remove the plate by moving it
rightwards.
8. Loosen the thumbscrew to remove the mounting plate and take out the electrode you
want to replace.
The electrodes should be arranged from left to right in this order: reference, Na, K and
Cl.
10.Check that an O-shape washer exists between every two electrodes, between the
reference electrode and the module, and between the Cl electrode and the module.
16-92
16 Maintenance
17.Type in the number of replicates for priming, and then select Start.
18.Check the priming closely and complete the following operations:
• If air bubbles appear continuously, check the connection part for leak and loose.
• Check if the liquid is drained steadily from the sample injection cup. If it is not
drained but increases, it indicates that the tubes are incorrectly connected or the
drain tube is clogged. Stop the priming.
• Take out the Na and K electrodes, and check their flow cell for blockage.
• If no error is found, the new electrodes are working normally.
19.When the priming is finished, install the stainless steel plate, tighten the screws and
restore the module cover on the analyzer’s front panel.
Maintenance-Other.
23.Mark the Select checkbox in the same row as Replace ISE Electrodes.
24.Select OK to refresh the current date as the performance date.
25.Select Log, and then record commends and other important information for the
procedure.
Purpose
To prime the ISE electrodes to make them moistened while the analyzer’s main power is
switched off.
16-93
16 Maintenance
When to do
Perform this procedure before powering off the analyzer for 1 to 2 days.
Materials required
Deionized water
System status
Make sure that the status of the ISE module is Standby.
Precautions
Warning
While performing the maintenance, keep away from the sample probe moving area to prevent
equipment damage or personal injury.
How to do
1. Select Utility-Maintenance-Maintenance- ISE Maintenance.
2. Choose Water Prime. The maintenance guide window shows. Select Continue.
4. Open the cover of the ISE module on the analyzer’s front panel.
5. Use a pipette to fill 750μl deionized water to the sample injection port.
7. After the priming, restore the cover of the ISE module and the upper protective shield of
the analyzer.
8. Select Done.
Maintenance-Other.
16-94
16 Maintenance
12.Select Log, and then record commends and other important information for the
procedure.
Purpose
To store the electrodes separately to prevent them from being damaged due to lack of water
while the analyzer is powered off.
Materials required
Electrode cases and spacer
When to do
Perform this procedure when the analyzer is going to be powered off for over 3 days. If it will
be powered off for no more than 3 days, prime the ISE electrodes to protect them from being
damaged.
System status
Make sure that the system is powered off.
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
How to do
1. Place the analyzing unit power to the OFF position.
2. Open the cover of the ISE module on the analyzer’s front panel.
3. Loosen the thumbscrew fixing the stainless steel plate and remove the plate by moving it
rightwards.
16-95
16 Maintenance
Method 1:
• Install the cap on the Cl and reference electrodes.
• Put a sponge in the electrode case and then fill the electrode case with 2ml buffer
solution.
Figure 16.29 Put sponge and fill buffer solution in electrode case
16-96
16 Maintenance
• Cover the electrode case seamlessly. The electrodes are moistened by the vapor of
the buffer solution, and airtightness of the electrode case, therefore, is very
important.
Figure 16.31 Seal electrode case
Method 2:
• Install the cap on the Cl and reference electrodes.
• Soak gauze with buffer solution and then screw it slightly. Wrap the electrodes
16-97
16 Maintenance
Figure 16.32 Wrap electrodes with gauze soaked with buffer solution
• Cover the electrode case seamlessly to ensure that the buffer solution in the gauze
will not be vaporized soon.
Figure 16.33 Seal electrode case
• Do not store the reference electrode by soaking it in buffer solution; otherwise, the
inner solution inside the electrode may spread out of it.
16-98
17 Alarms and Troubleshooting
17.1 Overview
The following pages describe how to view and edit error logs and edit logs, and how to locate
failure and determine relevant corrective actions. Read this chapter thoroughly to achieve the
best performance of the instrument.
17.2.1 Introduction
The logs provided by the system are divided into:
• Error log
• Edit log
Classification of failure
Failures are divided into the following types based on component, severity and processing
method:
17-1
17 Alarms and Troubleshooting
17-2
17 Alarms and Troubleshooting
2 Errors to invalidate tests Such errors indicate that the current tests are
invalidated due to the unqualified:
• Tests
• Reagents
• Samples
3 Errors to pause Such errors indicate that the failed component needs
to be diagnosed and restored, while other
components are not influenced. The errors may
occur on the following components:
• R1 aspirating and dispensing
• R2 aspirating and dispensing
• Sample carousel 1
• Sample carousel 2
• Sample probe
• Sample mixer
• Reagent mixer
• Wash unit
• Hydropneumatic assembly
• ISE module
4 Errors to stop a component Such errors indicate that the failed part cannot work
normally and should be checked immediately. The
components include:
• ISE module
• Reaction carousel
5 Errors to forbid a Such errors indicate that the failed unit is forbidden
component until it is restored. The components include:
• LIS
• Sample bar code module
• Reagent bar code module
17-3
17 Alarms and Troubleshooting
Error code
Each error has a unit code used for identification and locating probable causes and solutions.
An error code consists of 6 letters and numbers, such as “C01001”, in which “C” indicates
that the error occurs on the operation unit, “01” is the error description of instrument
connection, and “001” is the serial number of the error. Therefore, “C01001” is described as
“the first error of instrument connection on the operation unit”.
The following tables provide a summary of error codes for the operation unit and analyzing
unit.
17-4
17 Alarms and Troubleshooting
Help
Every error log is provided with online help information. Select the icon prior to an error
log. The descriptions, possible causes and solutions of the error are displayed.
17-5
17 Alarms and Troubleshooting
Every error log contains the event ID, date/time, error description (by processing method),
event class (by subsystem) and symptom.
Choose the following buttons as needed:
• Search F1: to search for error logs by date, event ID, symptom, or event class.
• Refresh F2: to refresh the error logs based on the current search conditions.
• Delete F3: to remove specified error logs on the screen.
• Archive F4: to archive all error logs within the specified period to an external storage
device.
• Print F7: to print all error logs currently displayed on the screen.
17-6
17 Alarms and Troubleshooting
Every edit log contains the serial number, date/time, operator, event type and description.
Choose the following buttons as needed:
• Search F1: to search for edit logs based on the occurring date.
• Refresh F2: to refresh the edit logs based on the current search conditions.
• Delete F3: to remove specified edit logs on the screen.
• Archive F4: to archive all edit logs within the specified period to an external storage
device.
• Print F7: to print all edit logs currently displayed on the screen.
17-7
17 Alarms and Troubleshooting
• Date
• Event ID (available for error logs only)
• Symptom (available for error logs only)
• Event class (available for error logs only)
4. Select OK. The event logs satisfying the conditions are displayed on the screen.
• Refresh F2: to refresh the logs based on the current search conditions.
• Delete F3: to remove specified logs on the screen.
• Archive F4: to archive all event logs occurring within a period of time.
• Print F7: to print all logs currently displayed on the screen.
3. The system refreshes the logs based on the previous search conditions.
• New error logs are displayed chronologically and highlighted by different colors.
Red indicates a warning, and red indicates a serious error.
• New edit logs are displayed chronologically on the front-most of the log list.
17-8
17 Alarms and Troubleshooting
When you confirm the deleting, the system remove the selected event logs on the screen.
• Error Log
17-9
17 Alarms and Troubleshooting
• Edit log
5. Select OK.
17.4.1 Introduction
When an error occurs, it will be indicated in many ways. The following pages describe how to
troubleshoot errors and help you determine solutions to such errors.
Generally, troubleshooting is divided into the following steps:
• An error occurs and is indicated in various ways.
• Check the error logs and component status.
• Identify the error and determine relevant solutions.
• Implement the solutions.
• Check and evaluate the implementation of the solutions.
Alarm tone
When an error occurs, the buzzer gives alarm tone reminding you to notice the error and take
corrective actions. Alarm tone can be adjusted manually or silenced.
Perform the following steps to adjust the alarm tone:
1. Select Utility-System.
17-10
17 Alarms and Troubleshooting
4. To silence the alarm tone, drag the slider to the leftmost position of the scale.
Alarm message
When an error occurs, the system gives an alarm and displays the alarm message in the
second line of the prompt message area. For details of troubleshooting, refer to 17.6 Error
Messages and Corrective Actions (page 17-20).
Color highlight
An error will be indicated by highlighting relevant buttons and screen texts with different
colors. Yellow indicates a warning, and red indicates a serious warning or error.
• Reagent button
• Utility button
• Alarm button
Select a button to access relevant function page, check for abnormities and take corrective
actions. When the problem is solved, the alarm indication disappears.
Flag
Flag is also called data alarm. When calibration error or failure, or sample result error occurs
due to the sample, reagent or system failure, a flag will appear near the corresponding
calibration result or sample results.
17-11
17 Alarms and Troubleshooting
Error log
All alarms are recorded in the error logs. By recalling the error logs you are enabled to master
the current status of the system and troubleshoot errors.
17.5.1 Introduction
Data alarm is a result flag indicating that an error or abnormity occurs to a result. By
identifying results flags can evaluate if the results are reliable and acceptable. Data alarm is
not necessarily an error but will definitely influence the result and should be considered
carefully.
The system provides monitoring of biochemistry results and ISE chemistry results. When
calibration error or failure, or sample result error occurs due to the sample, reagent or system
failure, a flag will appear near the corresponding calibration result or sample results. The
following pages summary the result flags of the system.
17-12
17 Alarms and Troubleshooting
17-13
17 Alarms and Troubleshooting
17-14
17 Alarms and Troubleshooting
17-15
17 Alarms and Troubleshooting
17-16
17 Alarms and Troubleshooting
17-17
17 Alarms and Troubleshooting
17-18
17 Alarms and Troubleshooting
17-19
17 Alarms and Troubleshooting
17-20
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
movement error. Sample probe horizontal movement error
Position: 1. Sensor status error:
Error: The sample probe assembly is probably forced to
move horizontally.
2. Failed to find the zero position:
The sample probe assembly is obstructed when
rotating.
3. Collision occurs during horizontal movement:
The sample probe assembly is obstructed when
rotating.
4. Moving horizontally is not allowed in current
position:
The sample probe assembly is probably forced to
move vertically.
Sample syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A01007 Sample probe Warning Sample probe collides / Sample probe vertical movement error Sample probe vertical movement error
unit with an obstacle when 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
aspirating The sample probe collides with other object. Remove the obstacle, and then recover
Position: failure by performing the Home
maintenance procedure.
A01021 Sample probe Error Clog detection board / Clog detection board communication error. Recover the failure. If this message
unit communication error. appears for 3 times, contact our
customer service department or your
local distributor.
17-21
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A01022 Sample probe Warning Sample syringe / The aspirate volume is beyond the range of the Define the aspirate volume correctly.
unit aspirates too much syringe.
Sample ID/bar code:
Position:
A01023 Sample probe Warning Sample syringe / The dispense volume is beyond the range of the Define the dispense volume correctly.
unit dispenses too much syringe.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A01024 Sample probe Warning Insufficient sample / There is no sample or insufficient sample on the 1. Check if the sample is sufficient, and
unit Position: designated position. then try again.
Sample ID/bar code: 2. If the error remains, contact our
customer service department or your
local distributor.
A01026 Sample probe Warning Sample probe dispenses / 1. The sample probe is clogged when aspirating. 1. Check if the sample satisfies the
unit insufficient sample 2. The sample probe aspirates nothing. requirement and is sufficient in volume,
Cuvette No.: and then try again.
Sample ID/bar code: 2. Recover the failure. If this message
Chemistry: appears for 3 times, contact our
customer service department or your
local distributor.
A01027 Sample probe Error Sample is insufficient or / There is no sample or insufficient sample on the 1. Check if the sample is sufficient, and
unit contains air bubbles designated position. then try again.
Sample ID/bar code: 2. If the error remains, contact our
customer service department or your
local distributor.
A01028 Sample probe Error Sample probe fails to / There is no deionized water, or the deionized 1. Check if the water supply is normal.
unit detect liquid level water is not supplied normally. 2. Recover the failure for 3 times. If the
during cleaning error remains, contact our Customer
Service Department or your local
17-22
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
distributor.
A01029 Sample probe Warning Sample is insufficient or / 1. The sample contains clots, or is too thick or 1. Check that the sample is
unit contains fibrins and insufficient. preprocessed correctly; or check if the
clogs 2. The sample probe is clogged. sample contains foreign matters such as
Sample ID/bar code: clot. If it does, change the sample.
Position: 2. Check if the sample is sufficient.
Clogging times of 3. Clean the sample probe with diluted
sample: wash solution. If the problem remains,
Clogging times of remove the sample probe and unclog it,
sample probe: and then continue with the
measurement.
A01030 Sample probe Error Sample probe is / The sample probe is clogged. 1. Clean the sample probe with diluted
unit clogged during wash solution. Remove the sample
cleaning. probe and unclog it.
Sample ID/bar code: 2. If the problem remains, contact the
Position: manufacturer.
Clogging times of
sample:
Clogging times of
sample probe:
A01031 Sample probe Error Sample probe / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
unit parameters are within switch on it again. Recover failure by
critical range performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
17-23
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A01033 Sample probe Warning Sample probe fails to / There is no reagent or insufficient reagent in the 1. Check if R1 volume is sufficient and
unit detect liquid level on reaction cuvette. the reagent bottle is free of air bubbles,
reaction carousel when and then try again.
dispensing 2. If the problem remains, contact the
Cuvette No.: manufacturer.
Sample ID/bar code:
Chemistry:
A01034 Sample probe Warning Liquid level at ISE / The electrodes are blocked; the ISE tubes have 1. Check if the ISE electrodes are
unit sample injection port is leak or are clogged; blocked.
too high The sample probe is low in sample injection 2. Check if the ISE tubes are leaking or
position of the ISE module. clogged.
3. If your attempt is failed, contact our
customer service department or your
local distributor.
A01035 Sample probe Warning Liquid level at ISE / The buffer solution is insufficient. Check the inventory of the buffer
unit sample injection port is The ISE tubes are leaking or clogged. solution, prime the ISE module with
too low buffer for about 20 cycles, and then try
again.
A01036 Sample probe Error Sample probe level / Level detection board communication error Recover the failure. If this message
unit detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A01037 Sample probe Error Sample probe level / 1. The sample probe is not installed correctly or 1. Check if the sample is installed
unit detection board self goes wrong. correctly or damaged.
calibrating failed 2. Level detection board communication error 2. Recover the failure. If your attempt is
failed, contact our customer service
department or your local distributor.
A01038 Sample probe Error Sample probe clog / Clog detection board communication error. Recover the failure. If this message
unit detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
17-24
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A02006 Probe R1 unit Error Probe R1 vertical / Reagent probe vertical movement error Switch off the analyzing unit power and
movement error 1. Sensor status error: switch on it again. Recover failure by
Position: The reagent probe assembly is probably forced to performing the Home maintenance
Error: move vertically. procedure. If this message appears for 3
times, contact our customer service
2. Failed to find the zero position:
department or your local distributor.
Or The reagent probe assembly is probably jammed.
3. Collision occurs during operation other than
Probe R1 horizontal aspirating:
movement error The reagent probe collides with other object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:
The reagent probe moves vertically in an
Probe R1 syringe unknown position.
movement error Reagent probe horizontal movement error
Position: 1. Sensor status error:
Error: The reagent probe assembly is probably forced to
move horizontally.
2. Failed to find the zero position:
The reagent probe assembly is obstructed when
rotating.
3. Collision occurs during horizontal movement:
The reagent probe assembly is obstructed when
rotating.
4. Moving horizontally is not allowed in current
position:
The reagent probe assembly is probably forced to
move vertically.
Reagent syringe movement error.
17-25
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
1. Sensor status error:
The syringe assembly is probably forced to move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A02007 Probe R1 unit Warning Probe R1 collides with / Reagent probe vertical movement error Reagent probe vertical movement error
an obstacle when 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
aspirating The reagent probe collides with other object. Remove the obstacle and then recover
Position: the failure.
A02021 Probe R1 unit Warning R1 syringe aspirates too / The aspirate volume is beyond the range of the Define the aspirate volume correctly.
much syringe.
Chemistry:
Position:
17-26
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A02022 Probe R1 unit Warning R1 syringe dispenses / The dispense volume is beyond the range of the Define the dispense volume correctly.
too much syringe.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A02023 Probe R1 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on the 1. Check if the reagent is sufficient, and
Chemistry: designated position. then try again.
Position on outer ring: 2. If the error remains, contact our
customer service department or your
local distributor.
A02025 Probe R1 unit Warning Probe R1 dispenses / 1. The reagent probe aspirates nothing. 1. Check if the reagent satisfies the
insufficient reagent requirement and is sufficient in volume,
Cuvette No.: and then try again.
Sample ID/bar code: 2. Recover the failure. If this message
Chemistry: appears for 3 times, contact our
customer service department or your
local distributor.
A02026 Probe R1 unit Error Probe R1 fails to detect / There is no deionized water, or the deionized 1. Check if the water supply is normal.
liquid level during water is not supplied normally. 2. If the error remains, contact our
cleaning. customer service department or your
local distributor.
A02027 Probe R1 unit Warning Water residues exist in / There is deionized water left in the reaction Recover the failure. If this message
the cuvette cuvette. appears for 3 times, contact our
Cuvette No.: customer service department or your
Sample ID/bar code: local distributor.
Chemistry:
17-27
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A02028 Probe R1 unit Error Probe R1 parameters / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
are within critical range. switch on it again. Recover failure by
Parameter performing the Home maintenance
Value: procedure. If this message appears for 3
times, contact our customer service
department or your local distributor.
A02029 Probe R1 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on the 1. Check if the reagent is sufficient, and
Chemistry: designated position. then try again.
Position on outer ring: 2. If the error remains, contact our
customer service department or your
local distributor.
A02030 Probe R1 unit Error Probe R1 level / Level detection board communication error Recover the failure. If this message
detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A02031 Probe R1 unit Error Probe R1 level / 1. Check if the probe R1 is installed
detection board self Level detection board communication error correctly and intact.
calibrating failed 2. Recover the failure. If this message
appears for 3 times, contact our
customer service department or your
local distributor.
A02032 Probe R1 unit Warning Reagent is insufficient / 1. Air bubbles exist in the reagent bottle. 1. Check if the reagent bottle contains
or contains air bubbles 2. The reagent bottle does not meet the air bubbles, and then try again.
Chemistry: requirements. 2. Check if the reagent bottle meets the
Position on outer ring: requirements.
3. If the error remains, contact our
customer service department or your
local distributor.
17-28
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A02033 Probe R1 unit Warning Insufficient reagent is / The reagent is insufficient, or air bubbles exist in 1. Check if the reagent is sufficient and
dispensed or air bubbles the reagent bottle. the reagent bottle contains air bubbles,
exist and then try again.
Cuvette No.: 2. If the problem remains, contact the
Sample ID/bar code: manufacturer.
Chemistry:
Position:
A03006 Probe R2 unit Error Probe R2 vertical / Reagent probe vertical movement error Recover the failure. If this message
movement error 1. Sensor status error: appears for 3 times, contact our
Position: The reagent probe assembly is probably forced to customer service department or your
Error: move vertically. local distributor.
2. Failed to find the zero position:
Or The reagent probe assembly is probably jammed.
3. Collision occurs during operation other than
Probe R2 horizontal aspirating:
movement error The reagent probe collides with other object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:
The reagent probe moves vertically in an
Probe R2 syringe unknown position.
movement error Reagent probe horizontal movement error
Position: 1. Sensor status error:
Error: The reagent probe assembly is probably forced to
move horizontally.
2. Failed to find the zero position:
The reagent probe assembly is obstructed when
rotating.
3. Collision occurs during horizontal movement:
17-29
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
The reagent probe assembly is obstructed when
rotating.
4. Moving horizontally is not allowed in current
position:
The sample probe assembly is probably forced to
move vertically.
Reagent syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to move.
2. Failed to find the zero position:
The syringe assembly is probably jammed.
A03007 Probe R2 unit Error Probe R2 collides with / Reagent probe vertical movement error Reagent probe vertical movement error
an obstacle when 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
aspirating The reagent probe collides with other object. Remove the obstacle and then recover
Position: the failure.
A03021 Probe R2 unit Warning Probe R2 syringe / The aspirate volume is beyond the range of the Define the aspirate volume correctly.
aspirates too much syringe.
Chemistry:
Position:
17-30
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A03022 Probe R2 unit Warning Probe R2 syringe / The dispense volume is beyond the range of the Define the dispense volume correctly.
dispenses too much syringe.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A03023 Probe R2 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on the 1. Check if the reagent is sufficient, and
Chemistry: designated position. then try again.
Position on inner ring: 2. If the error remains, contact our
customer service department or your
local distributor.
A03025 Probe R2 unit Warning Probe R2 dispenses / 1. The reagent probe aspirates nothing. 1. Check if the reagent satisfies the
insufficient reagent requirement and is sufficient in volume,
Cuvette No.: and then try again.
Sample ID/bar code: 2. Recover the failure. If this message
Chemistry: appears for 3 times, contact our
customer service department or your
local distributor.
A03026 Probe R2 unit Error Probe R2 fails to detect / There is no deionized water, or the deionized 1. Check if the water supply is normal.
liquid level during water is not supplied normally. 2. If the problem remains, contact the
cleaning. manufacturer.
A03028 Probe R2 unit Error Probe R2 parameters / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
are within critical range. switch on it again. Recover failure by
Parameter performing the Home maintenance
Value: procedure. If this message appears for 3
times, contact our customer service
department or your local distributor.
17-31
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A03029 Probe R2 unit Warning Insufficient reagent / There is no reagent or insufficient reagent on the 1. Check if the reagent is sufficient, and
Chemistry: designated position. then try again.
Position on inner ring: 2. If the error remains, contact our
customer service department or your
local distributor.
A03030 Probe R2 unit Error Probe R2 level / Level detection board communication error Recover the failure. If this message
detection board appears for 3 times, contact our
communication error customer service department or your
local distributor.
A03031 Probe R2 unit Error Probe R2 level / 1. The probe R2 is not installed correctly or goes Recover the failure. If this message
detection board self wrong. appears for 3 times, contact our
calibrating failed 2. Level detection board communication error customer service department or your
local distributor.
A03032 Probe R2 unit Warning Reagent is insufficient / 1. Air bubbles exist in the reagent bottle. 1. Check if the reagent bottle contains
or contains air bubbles 2. The reagent bottle does not meet the air bubbles, and then try again.
Chemistry: requirements. 2. Check if the reagent bottle meets the
Position on inner ring: requirements.
3. If the error remains, contact our
customer service department or your
local distributor.
17-32
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A04006 Sample mixer Error Sample mixer vertical / Sample mixer vertical movement error Switch off the analyzing unit power and
unit movement error 1. Sensor status error switch on it again. Recover failure by
Position: The sample mixer assembly is probably forced to performing the Home maintenance
Error: move vertically. procedure. If this message appears for 3
times, contact our customer service
2. Failed to find the zero position
department or your local distributor.
Or The sample mixer assembly is probably jammed.
3. Moving vertically is not allowed in current
Sample mixer position
horizontal movement The sample mixer moves vertically in an
error unknown position.
Position: Sample mixer horizontal movement error
Error: 1. Sensor status error
The sample mixer assembly is probably forced to
move horizontally.
2. Failed to find the zero position
The sample mixer assembly is obstructed when
rotating.
3. Moving horizontally is not allowed in current
position
The sample mixer moves vertically in an
unknown position.
A04015 Sample mixer Error Sample mixer rotation / The mixer is obstructed by other object or Recover failure by performing the
unit error interfered by the reaction cuvette. Home maintenance procedure. If this
Rotation speed: message appears for 3 times, contact
our customer service department or
your local distributor.
A04016 Sample mixer Error Sample mixer / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
unit parameters are within switch on it again. Recover failure by
critical range. performing the Home maintenance
Parameter procedure. If this message appears for 3
17-33
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Value: times, contact our customer service
department or your local distributor.
A05006 Reagent mixer Error Reagent mixer vertical / Reagent mixer vertical movement error Switch off the analyzing unit power and
unit movement error 1. Sensor status error switch on it again. Recover failure by
Position: The reagent mixer assembly is probably forced to performing the Home maintenance
Error: move vertically. procedure. If this message appears for 3
times, contact our customer service
2. Failed to find the zero position
department or your local distributor.
Or The reagent mixer assembly is probably jammed.
3. Moving vertically is not allowed in current
Reagent mixer position
horizontal movement The reagent mixer moves vertically in an
error unknown position.
Position: Reagent mixer horizontal movement error
Error: 1. Sensor status error
The reagent mixer assembly is probably forced to
move vertically.
2. Failed to find the zero position
The reagent mixer assembly is obstructed when
rotating.
3. Moving horizontally is not allowed in current
position
The reagent mixer moves vertically in an
unknown position.
A05016 Reagent mixer Error Reagent mixer rotation / The mixer is obstructed by other object or Recover failure by performing the
unit error interfered by the reaction cuvette. Home maintenance procedure. If this
Rotation speed: message appears for 3 times, contact
our customer service department or
your local distributor.
17-34
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A05017 Reagent mixer Error Reagent mixer / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
unit parameters are within switch on it again. Recover failure by
critical range. performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
A06006 Reaction Error Reaction carousel / Reaction carousel movement error Switch off the analyzing unit power and
carousel unit movement error 1. Failed to find the home position switch on it again. Recover failure by
Error: The reaction carousel is obstructed or blocked. performing the Home maintenance
procedure. If this message appears for 3
2. The coder missed steps
times, contact our customer service
The reaction carousel is obstructed or blocked. department or your local distributor.
3. The reaction carousel missed steps when
moving to the home position.
The reaction carousel is obstructed or blocked.
A06009 Reaction Error Reaction carousel / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
carousel unit parameters are within switch on it again. Recover failure by
critical range performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
A07006 Sample carousel Error Sample carousel outer / Sample carousel outer ring movement error Recover the failure. If this message
1 unit ring movement error 1. Failed to find the home position appears for 3 times, contact our
Error: The sample carousel outer ring is obstructed or customer service department or your
blocked. local distributor.
2. The coder missed steps
The sample carousel outer ring is obstructed or
blocked.
3. The sample carousel outer ring missed steps
when moving to the home position.
The sample carousel outer ring is obstructed or
17-35
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
blocked.
A07009 Sample carousel Error Sample bar code error / The sample bar coder reader goes wrong due to Recover the failure. If the error
1 unit system failure. remains, initialize the sample bar code
reader. If the error still remains, contact
our Customer Service Department or
your local distributor.
A07010 Sample carousel Warning Sample bar code error / Sample bar coder reader does not work normally Initialize the sample bar code reader
1 unit Position: due to communication error. and try again. If your attempt is failed,
contact our customer service
department or your local distributor.
A07011 Sample carousel Error Sample bar code / Sample bar coder sending buffer is full due to Recover the failure or reboot the
1 unit sending buffer is full communication error. analyzing unit.
A07012 Sample carousel Error Parameters of sample / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
1 unit carousel outer ring are switch on it again. Recover the failure.
within critical range If this message appears for 3 times,
Parameter contact our customer service
Value: department or your local distributor.
17-36
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A08006 Sample carousel Error Sample carousel inner / Sample carousel inner ring movement error Switch off the analyzing unit power and
2 unit ring movement error 1. Failed to find the home position switch on it again. Recover the failure.
Error: The sample carousel inner ring is obstructed or If this message appears for 3 times,
blocked. contact our customer service
department or your local distributor.
2. The coder missed steps
The sample carousel inner ring is obstructed or
blocked.
3. The sample carousel inner ring missed steps
when moving to the home position.
The sample carousel inner ring is obstructed or
blocked.
A08009 Sample carousel Error Sample bar code reader / The sample bar coder reader goes wrong due to Recover the failure. If the error
2 unit goes wrong system failure. remains, initialize the sample bar code
reader. If the problem remains, initialize
the sample bar code reader. If the error
still remains, contact our Customer
Service Department or your local
distributor.
A08010 Sample carousel Warning Sample bar code error / Sample bar coder reader does not work normally Initialize the sample bar code reader
2 unit Position: due to communication error. and try again. If your attempt is failed,
contact our customer service
department or your local distributor.
A08011 Sample carousel Error Sample bar code / Sample bar coder sending buffer is full due to Recover the failure or reboot the
2 unit sending buffer is full communication error. analyzing unit.
A08012 Sample carousel Error Parameters of sample / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
2 unit carousel inner ring are switch on it again. Recover failure by
within critical range performing the Home maintenance
Parameter procedure. If this message appears for 3
times, contact our customer service
17-37
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
Value: department or your local distributor.
A09006 Reagent Error Reagent carousel outer / Reagent carousel outer ring movement error Recover the failure. If this message
carousel 1 unit ring movement error 1. Failed to find the home position appears for 3 times, contact our
Error: The reagent carousel outer ring is obstructed or customer service department or your
blocked. local distributor.
2. The coder missed steps
The reagent carousel outer ring is obstructed or
blocked.
3. The reagent carousel outer ring missed steps
when moving to the home position.
The reagent carousel outer ring is obstructed or
blocked.
A09009 Reagent Error Reagent carousel cover / The reagent carousel cover is removed. Restore the reagent carousel cover.
carousel 1 unit is opened compulsively
A09011 Reagent Error Reagent bar code reader / The reagent bar coder reader goes wrong due to Recover the failure. If the error
carousel 1 unit does not work normally system failure. remains, initialize the sample bar code
reader. If the problem remains, initialize
the sample bar code reader. If the error
still remains, contact our Customer
Service Department or your local
distributor.
A09012 Reagent Warning Reagent bar code reader / Reagent bar coder sending buffer is full due to Initialize the sample bar code reader
carousel 1 unit data error communication error. and try again. If your attempt is failed,
Position: contact our customer service
department or your local distributor.
17-38
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A09014 Reagent Error Reagent bar code / Reagent bar coder reader does not work normally Recover the failure or reboot the
carousel 1 unit sending buffer is full due to communication error. analyzing unit.
Position:
A09015 Reagent Error Parameters of reagent / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
carousel 1 unit carousel outer ring are switch on it again. Recover failure by
within critical range performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
A09016 Reagent Error Reagent carousel is / The reagent carousel stops rotating and scanning Restore the reagent carousel cover and
carousel 1 unit opened compulsively is terminated, because the reagent carousel cover recover the failure, and then try again.
during scanning is removed during scanning.
A10006 Reagent Error Reagent carousel inner / Reagent carousel inner ring movement error Switch off the analyzing unit power and
carousel 2 unit ring movement error 1. Failed to find the home position switch on it again. Recover failure by
Error: The reagent carousel inner ring is obstructed or performing the Home maintenance
blocked. procedure. If this message appears for 3
times, contact our customer service
2. The coder missed steps
department or your local distributor.
The reagent carousel inner ring is obstructed or
blocked.
3. The reagent carousel inner ring missed steps
when moving to the home position.
The reagent carousel inner ring is obstructed or
blocked.
A10009 Reagent Error Reagent carousel cover / The reagent carousel cover is removed. Restore the reagent carousel cover.
carousel 2 unit is opened compulsively
17-39
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A10011 Reagent Error Reagent bar code reader / The reagent bar coder reader goes wrong due to Recover the failure. If the error
carousel 2 unit does not work normally system failure. remains, initialize the sample bar code
reader. If the problem remains, initialize
the sample bar code reader. If the error
still remains, contact our customer
service department or your local
distributor.
A10012 Reagent Warning Reagent bar code error. / Reagent bar coder sending buffer is full due to Initialize the sample bar code reader
carousel 2 unit Position: communication error. and try again. If your attempt is failed,
contact our customer service
department or your local distributor.
A10014 Reagent Error Reagent bar code / Reagent bar coder reader does not work normally Recover the failure or reboot the
carousel 2 unit sending buffer is full due to communication error. analyzing unit.
Position:
A10015 Reagent Error Parameters of reagent / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
carousel 2 unit carousel inner ring are switch on it again. Recover failure by
within critical range performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
A10016 Reagent Error Reagent carousel is / The reagent carousel stops rotating and scanning Restore the reagent carousel cover and
carousel 2 unit opened compulsively is terminated, because the reagent carousel cover recover the failure, and then try again.
during scanning is removed during scanning.
17-40
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11005 Wash station Error Wash station movement / Wash station movement error Switch off the analyzing unit power and
error 1. Sensor status error switch on it again. Recover failure by
Error: The wash station assembly is probably forced to performing the Home maintenance
move. procedure. If this message appears for 3
times, contact our customer service
2. Failed to find the home position
department or your local distributor.
The wash station assembly is obstructed by other
object.
3. The wash station collides with an obstacle
when moving.
The wash station collides with other object, or the
wash probes then collide with the reaction
carousel.
A11010 Wash station Error Releasing vacuum / 1. Solenoid valves V23-V27 go wrong. 1. Check if the error is accidental.
failed 2. The vacuum pump goes wrong. 2. If the error is not accidental, contact
3. The vacuum sensor goes wrong. our customer service department or
your local distributor.
A11012 Wash station Warning Water supplying is too / 1. The water unit goes wrong. 1. Check the water unit.
slow 2. The water supply valve goes wrong. 2. Check if the water supply ball valve
3. The water supply ball valve is not opened. is opened and the handle is level.
4. The water supply ball valve goes wrong. 3. Check if the water supply tube is
5. The low-level floater of the water tank goes smooth.
wrong. 4. Check if the water level inside the
6. The water supply tube is bent. water tank is low (at the scale of 5L).
7. The outlet filter of the water supply tube is 5. Check if the error is accidental.
clogged. 6. If the error is not accidental, contact
our customer service department or
your local distributor.
17-41
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11013 Wash station Error Water tank is empty / 1. The water unit goes wrong. 1. Check the water unit.
2. The water supply valve goes wrong. 2. Check if the water supply ball valve
3. The water supply ball valve is not opened. is opened and the handle is level.
4. The water supply ball valve goes wrong. 3. Check if the water supply tube is
5. The low-level floater of the water tank goes smooth.
wrong. 4. Check if the water level inside the
6. The water supply tube is bent. water tank is low (at the scale of 5L).
7. The outlet filter of the water supply tube is 4. Check if the error is accidental.
clogged. 5. If the error is not accidental, contact
our customer service department or
your local distributor.
A11014 Wash station Warning Priming diluted wash / 1. The solenoid valve V06 goes wrong. 1. Check if the P03 pump is opened and
solution is slow 2. The restrictor ring is clogged. the pressure gauge reads between
3. The inlet filter at the front panel is clogged. 40kPa-50kPa.
4. The P03 pump goes wrong. 2. Check the floater of the deionized
water tank.
5. The water tank is empty.
3. Check the floater of the diluted wash
6. The concentrated wash solution tank is empty.
solution tank.
7. The concentrated wash solution pump goes
4. Check the floater of the concentrated
wrong.
wash solution tank.
8. The low-level floater of the diluted wash
5. Check if the error is accidental.
solution tank goes wrong.
6. If the error is not accidental, contact
our customer service department or
your local distributor.
17-42
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11015 Wash station Error Insufficient diluted / 1. The solenoid valve V06 goes wrong. 1. Check if the P03 pump is opened and
wash solution 2. The restrictor ring is clogged. the pressure gauge reads between
3. The inlet filter at the front panel is clogged. 40kPa-50kPa.
4. The P03 pump goes wrong. 2. Check the floater of the deionized
water tank.
5. The water tank is empty.
3. Check the floater of the diluted wash
6. The concentrated wash solution tank is empty.
solution tank.
7. The concentrated wash solution pump P05 goes
4. Check the floater of the concentrated
wrong.
wash solution tank.
8. The low-level floater of the diluted wash
5. Check if the error is accidental.
solution tank goes wrong.
6. If the error is not accidental, contact
our customer service department or
your local distributor.
A11016 Wash station Warning Insufficient / 1. Concentrated wash solution is exhausted and 1. Check if the concentrated wash
concentrated wash the floater status is Empty. solution is exhausted and the floater
solution 2. The low-level floater of the concentrated wash status is Empty. If yes, fill more
solution tank goes wrong. concentrated wash solution.
2. Check if the error is accidental.
3. If the error is not accidental, contact
our customer service department or
your local distributor.
A11017 Wash station Error Liquid accumulates in / 1. The solenoid valve V27 goes wrong. 1. Check if the error is accidental.
primary vacuum 2. The waste pump P07 goes wrong. 2. If the error is not accidental, contact
container 3. The low-concentration waste drain tube is bent. our customer service department or
your local distributor.
A11018 Wash station Error High concentration / 1. The waste pump P07 goes wrong. 1. Check if the error is accidental.
waste collector is full 2. The high-concentration waste drain tube is 2. If the error is not accidental, contact
bent. our customer service department or
your local distributor.
17-43
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11019 Wash station Error Low concentration / 1. The waste pump P07 goes wrong. 1. Check if the error is accidental.
waste collector is full 2. The low-concentration waste drain tube is bent. 2. If the error is not accidental, contact
our customer service department or
your local distributor.
A11020 Wash station Error High concentration / 1. The high concentration waste tank is full 1. Check the high-concentration waste
waste tank is full 2. The floater of the high concentration waste tank tank. If it is full, replace the waste tank,
goes wrong. close the full tank and dispose of the
waste properly.
2. Check if the error is accidental.
3. If the error is not accidental, contact
our customer service department or
your local distributor.
A11021 Wash station Error ISE degassing pressure / 1. The solenoid valve V29 goes wrong. 1. Check if the error is accidental.
is too low 2. The ISE vacuum sensor goes wrong. 2. If the error is not accidental, contact
3. The ISE degasser goes wrong. our customer service department or
your local distributor.
A11022 Wash station Error ISE degassing pressure / 1. The solenoid valve V29 goes wrong. 1. Check if the error is accidental.
is too high 2. The ISE degasser pump P12 goes wrong. 2. If the error is not accidental, contact
3. The ISE vacuum sensor goes wrong. our customer service department or
4. The ISE degasser goes wrong. your local distributor.
5. The connectors and tubes go wrong.
A11023 Wash station Error Insufficient vacuum / 1. The primary vacuum pump P08 goes wrong. 1. Check if the error is accidental.
2. The primary vacuum sensor goes wrong. 2. If the error is not accidental, contact
3. The connectors and tubes go wrong. our customer service department or
4. The primary vacuum container goes wrong. your local distributor.
5. Solenoid valves V23-V26 go wrong.
17-44
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A11024 Wash station Warning Degassing unit pressure / 1. The solenoid valve V28 goes wrong. 1. Check if the error is accidental.
is too low 2. The degassing vacuum sensor goes wrong. 2. If the error is not accidental, contact
3. The degasser goes wrong. our customer service department or
your local distributor.
A11025 Wash station Warning Degassing unit pressure / 1. The solenoid valve V28 goes wrong. 1. Check if the error is accidental.
is too high 2. The degasser pump P09 goes wrong. 2. If the error is not accidental, contact
3. The degassing vacuum sensor goes wrong. our customer service department or
4. The degasser goes wrong. your local distributor.
5. The connectors and tubes go wrong.
A11026 Wash station Error Wash unit parameters / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
are within critical range. switch on it again. Recover failure by
Parameter performing the Home maintenance
Value: procedure. If this message appears for 3
times, contact our customer service
department or your local distributor.
A12005 Temperature Warning Reaction carousel T1 1. The ambient temperature is out of range. 1. Check if the error is accidental.
unit temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental, contact
range (component error and cable error) our customer service department or
TDISP temperature: 3. The temperature protection switch goes wrong. your local distributor.
TS01: (component error and cable error)
TS02: 4. The heater goes wrong. (component error and
TS03:(Adjusted cable error)
temperature ∆T for 3 5. PCB error
Pt1000 sensors) 6. Parameters are lost.
7. Electromagnetic interference exists.
17-45
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A12006 Temperature Warning Temperature of wash / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit solution for cleaning 2. The temperature sensor goes wrong. deionized water for cleaning the whole
cuvettes is out of range (component error and cable error) unit.
Temperature: 3. The temperature protection switch goes wrong. 2. Check if the water supply is normal
(component error and cable error) and has the temperature between
4. The heater goes wrong. (component error and 15°C-30°C.
cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental, contact
6. Parameters are lost. our customer service department or
your local distributor.
7. Electromagnetic interference exists.
A12007 Temperature Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the whole
cleaning cuvettes is out (component error and cable error) unit.
of range 3. The temperature protection switch goes wrong. 2. Check if the water supply is normal
Temperature: (component error and cable error) and has the temperature between
4. The heater goes wrong. (component error and 15°C-30°C.
cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental, contact
6. Parameters are lost. our customer service department or
your local distributor.
7. Electromagnetic interference exists.
17-46
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A12008 Temperature Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
unit deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the whole
cleaning the whole unit (component error and cable error) unit.
is out of range 3. The temperature protection switch goes wrong. 2. Check if the water supply is normal
Temperature: (component error and cable error) and has the temperature between
4. The heater goes wrong. (component error and 15°C-30°C.
cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental, contact
6. Parameters are lost. our customer service department or
your local distributor.
7. Electromagnetic interference exists.
A12009 Temperature Warning Internal temperature of / 1. The ambient temperature is out of range. 1. Check if the air vent is blocked.
unit the whole unit is out of 2. The cooling fan goes wrong. Clean the dust screen if it is blocked.
range 3. The dust screen is blocked. 2. Check if enough space is reserved
Temperature: 4. The air vent is blocked in the specified range. between the air vent and the wall. If
not, reallocate the instrument.
3. Check if the error is accidental.
4. If the error is not accidental, contact
our customer service department or
your local distributor.
A12012 Temperature Error Temperature unit / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
unit parameters are within switch on it again. Recover failure by
critical range. performing the Home maintenance
Parameter procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
17-47
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13006 ISE module Error ISE communication / ISE module error: Recover the failure and then rerun the
error operating software.
A13007 ISE module Error ISE calibration factor / The current calibration factors of the ISE module Recalibrate the ISE module.
error cannot be used.
A13008 ISE module Error Operation of ISE / ISE module error: Recover the failure and then rerun the
module is abnormal operating software.
Instruction:
A13009 ISE module Error ISE configuration / The configured parameters exceed the allowable Enter the parameters again, or restore
parameter error values. them to the default values.
Instruction:
A13010 ISE module Error ISE module accepts no / ISE module error: Recover the failure and then rerun the
instruction in current operating software.
status
Instruction:
A13011 ISE module Error ISE module error: / ISE module error: Recover the failure and then rerun the
Sample IDs for sample operating software.
programming and
dispensing do not match
A13012 ISE module Warning ISE module error: Not / The test data is insufficient for calculating the CV Perform the precision test again for at
enough data for CV value. least 2 times.
calculation
17-48
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13013 ISE module Error ISE module error: ADC / The ADC of the ISE module is not initialized 1. Check the connection of electrodes,
initialization error normally. ground terminal and temperature
sensor, and then recover the failure.
2. Switch off the main power and then
switch on it again after 10 seconds.
Perform the startup procedure.
A13014 ISE module Warning ISE module error: ADC ADC The ISE electrodes, ground terminal and 1. Check the connection of electrodes,
out of range temperature sensor are not connected correctly. ground terminal and ISE temperature
Chemistry: sensor, and then recover the failure.
2. Switch off the main power and then
switch on it again after 10 seconds.
Perform the startup procedure.
A13016 ISE module Warning ISE module error: ADC T2 The ISE temperature sensor is not connected Check if the temperature sensor is
out of rangeISE module correctly. connected correctly, and then recover
error: Beyond the failure.
temperature sensor
rangeBeyond
temperature sensor
range
17-49
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13018 ISE module Warning Calibration failed. DILO The calibrator is stored for too long time, or the 1. Replace the calibrator and
Dilution rate out of electrode is degenerated. recalibrate.
range The electrode is not installed correctly. 2. Reinstall the electrode. Make sure
Chemistry: that an O-shape washer exists between
every two electrodes, and between the
electrode and the module.
3. Replace the electrode.
4. Check if the calibration status of the
chemistry is Cal Failed.
A13019 ISE module Warning Calibration failed. DILE The calibrator is stored for too long time, or the 1. Replace the calibrator and
Dilution rate calculation electrode is degenerated. recalibrate.
error. The electrode is not installed correctly. 2. Reinstall the electrode. Make sure
Chemistry: that an O-shape washer exists between
every two electrodes, and between the
electrode and the module.
3. Replace the electrode.
4. Check if the calibration status of the
chemistry is Cal Failed.
A13020 ISE module Warning Calibration failed. Slope SLO The calibrator is stored for too long time, or the 1. Replace the calibrator and
out of range electrode is degenerated. recalibrate.
Chemistry: The electrode is not installed correctly. 2. If the electrode is new, activate it and
then recalibrate.
3. Reinstall the electrode. Make sure
that an O-shape washer exists between
every two electrodes, and between the
electrode and the module.
4. Replace the electrode.
5. Check if the calibration status of the
chemistry is Cal Failed.
17-50
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13021 ISE module Warning Calibration failed. Slope SLE The calibrator is stored for too long time, or the 1. Replace the calibrator and
calculation error electrode is degenerated. recalibrate.
Chemistry: The electrode is not installed correctly. 2. If the electrode is new, activate it and
then recalibrate.
3. Reinstall the electrode. Make sure
that an O-shape washer exists between
every two electrodes, and between the
electrode and the module.
4. Replace the electrode.
5. Check if the calibration status of the
chemistry is Cal Failed.
A13022 ISE module Warning Calibration failed. Cl BIAS The Cl electrode is dirty. 1. Clean the electrode repeatedly and
bias out of range. The Cl electrode is degenerated. then recalibrate.
2. Replace the Cl electrode.
3. Check if the calibration status of Cl
is Cal Failed.
A13023 ISE module Error ISE calibration failed. REPL The calibration repeatability of the ISE module is 1. Replace the calibrator and
Calibration replicates poor. recalibrate.
exceed set value. 2. If the electrode is new, activate it and
then recalibrate.
3. Check the connection of the ISE
buffer tank and then recalibrate.
17-51
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13024 ISE module Error ISE calibration aborted. SEN 1. The calibrator is placed in an incorrect position, 1. Check the calibrator position and
Electrode voltage out of or the electrode is not connected correctly. replace the calibrator, check if the
range 2. The electrode is degenerated. electrode is connected correctly, and
3. The sample probe aspirates or dispenses then recalibrate.
incorrectly. (The error occurs for several ISE 2. If the electrode is new, activate it and
chemistries.) then recalibrate.
3. Replace the electrode.
A13025 ISE module Warning Electrode voltage out of SEN 1. The calibrator is placed in an incorrect position. 1. Check the calibrator position and
range during ISE 2. The electrode is degenerated. replace the calibrator, check if the
calibration 3. The sample probe aspirates or dispenses electrode is connected correctly, and
Chemistry: incorrectly. (The error occurs for several ISE then recalibrate.
chemistries.) 2. If the electrode is new, activate it and
then recalibrate.
3. Replace the electrode.
A13026 ISE module Warning ISE calibration DUP Calibrator of the same concentration level will be If the calibration is succeeded, ignore
tolerance out of range run repeatedly on the ISE module. If the the error; If the calibration is failed,
Chemistry: difference between two adjacent runs is beyond take relevant actions according to the
the set range, this warning will be triggered. alarm.
A13027 ISE module Error ISE test order error / ISE module error: Recover the failure.
A13028 ISE module Error ISE syringe fails to / ISE module error: Recover the failure.
reach home position.
A13029 ISE module Error ISE syringe fails to / ISE module error: Recover the failure.
leave home position.
17-52
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A13030 ISE module Error ISE syringe fails to / ISE module error: Recover the failure.
reach home position.
A13031 ISE module Error ISE syringe movement / ISE module error: Recover the failure.
error: Syringe fails to
leave home position.
A13032 ISE module Warning ISE syringe already / The syringe already reaches the top. Stop clicking on the Buffer Syringe Up
reaches the top. button.
A13033 ISE module Warning ISE syringe already / The syringe already reaches the bottom. Stop clicking on the Buffer Syringe
reaches the bottom. Down button.
A14005 Reagent Error Parameters of reagent / Parameters of the control unit are incorrect. Switch off the analyzing unit power and
refrigeration refrigeration unit are switch on it again. Recover failure by
unit within critical range performing the Home maintenance
Parameter: procedure. If this message appears for 3
Value: times, contact our customer service
department or your local distributor.
17-53
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A14006 Reagent Warning Reagent refrigeration / 1. The ambient temperature is out of range. 1. Check if the error is accidental.
refrigeration temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental, contact
unit range (component error and cable error) our customer service department or
TrDISP: 3. The temperature protection switch goes wrong. your local distributor.
(component error and cable error)
4. The radiator goes wrong. (component error and
cable error)
5. The fan goes wrong. (component error and
cable error)
6. The recycle pump goes wrong. (component
error and cable error)
7. The refrigerant goes wrong.
8. PCB error
9. Parameters are lost.
10. Electromagnetic interference exists.
A14007 Reagent Warning Temperature of / 1. The ambient temperature is out of range. 1. Check if the error is accidental.
refrigeration refrigeration module is 2. The temperature sensor goes wrong. 2. If the error is not accidental, contact
unit low (component error and cable error) our customer service department or
Tcp: 3. The recycle pump goes wrong. (component your local distributor.
error and cable error)
4. The refrigerant goes wrong.
5. PCB error
6. Parameters are lost.
7. Electromagnetic interference exists.
17-54
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A14008 Reagent Warning Liquid pump fan is / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
A14011 Reagent Warning Reagent refrigerating / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration fan 1 is abnormal 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
A14012 Reagent Warning Reagent refrigerating / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration fan 2 is abnormal 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
A14013 Reagent Error Light source fan is / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
A14014 Reagent Warning Air pump fan is / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration abnormal 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
A14015 Reagent Warning ISE fan is abnormal / 1. The fan is blocked. 1. Check if the error is accidental.
refrigeration 2. The fan is damaged. 2. If the error is not accidental, contact
unit 3. The power supply goes wrong. our customer service department or
your local distributor.
C00001 Operating Error Incompatible operating / The operating system is not Windows XP. Reinstall Windows XP and the
system system. Please install operating software.
Windows XP
17-55
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C00002 Operating Error Memory is less than 2G / The memory is less than 1.5G. Install a memory above 1.5G and then
system reboot the operating system.
C00003 Operating Error Resolution error / The screen resolution is not 1280*1024. Set the screen resolution to 1280*1024.
system
C00004 Operating Error Color error / The color is below 16 bit. Set the color to above 16 and then
system reboot the operating system.
C00005 Operating Warning Insufficient disk space / The remaining disk space is less than 4G. Rearrange the hard disk and delete the
system useless documents.
C00006 Operating Error Out of disk space / The remaining disk space is less than 1G. Rearrange the hard disk and delete the
system useless documents.
C00007 Operating Error CPU performance low / The CPU is too busy. Reboot the computer and operating
system software. If this message appears for 3
times, contact our customer service
department or your local distributor.
C00008 Operating Warning Printer cannot be / The printer is not powered on; the printer cable is Check the printer connection; check if
system connected not connected; or no driver is installed. the printer is powered on and if the
driver and default printer have been
installed.
C00009 Operating Warning Printer failure / Paper jam. No paper. No ink Check for paper jam. Check if printer is
system busy, and print tasks are too many.
C00010 Operating Warning Print paper running out / Paper jam. No paper. No ink Check for paper jam. Check if printer is
system busy, and print tasks are too many.
17-56
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C00012 Operating Warning Sound card failure / No sound card is installed. Sound card failure. Reinstall the sound card or the sound
system Incorrect sound card driver. card driver.
C01001 Instrument Error Equipment cannot be / The serial cable is not connected; or the analyzing Check the serial port connection.
connection connected unit power is switched off. Replug the cable. Check if the
analyzing unit is powered on. Start the
initialization again. Restart the
computer and analyzing unit. If three
continuous attempts are failed, contact
our customer service department or
your local distributor.
C01002 Instrument Error Instruction response / Communication error. Check the serial port cable and replug
connection error it. Switch off the analyzing unit power
and switch on it again. Recover failure
by performing the Home maintenance
procedure. If this message appears for 3
times, contact our customer service
department or your local distributor.
C02001 Database Error Database initialing / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts are
failed, contact our customer service
department or your local distributor.
C02002 Database Error Database upgrade failed / The database file is damaged or lost. Reboot the computer and analyzing
unit. If three continuous attempts are
failed, contact our customer service
department or your local distributor.
C02004 Database Warning Database backup failed / The database file is damaged or lost. Reboot the computer and analyzing
unit. If three continuous attempts are
failed, contact our customer service
department or your local distributor.
17-57
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C02005 Database Warning Reading/Writing / The database does not work normally. Reboot the computer and analyzing
database failed unit. If three continuous attempts are
failed, contact our customer service
department or your local distributor.
C03001 Result Warning Result cannot be RCE Absorbance data for calculation is incomplete, or Rerun the test. If the error remains,
calculation calculated the dividend is 0. contact our customer service
Sample ID/bar code: department or your local distributor.
Position:
Chemistry:
C03002 Result Warning Absorbance out of ABS The absorbance measured at the primary and Check the sample for foreign matters or
calculation range secondary wavelength is greater than 3.4A. interferents; check if the reagent is
Sample ID/bar code: qualified and placed in the correct
Position: position; check the cuvette is clean;
check if the photometric system is
Chemistry:
working normally.Check the sample for
foreign matters or interferents; check if
the reagent is qualified and placed in
the correct position; check if the cuvette
and lamp are normal. If the problem
remains, contact our customer service
department or your local distributor.
C03003 Result Warning R1 blank absorbance RBK The reagent goes wrong; the cuvette is not clear; Check if the cuvette is not overflowed,
calculation out of range the reaction cuvette is overflowed; or insufficient the reagent is sufficient without air
Sample ID/bar code: reagent is dispensed. bubbles, the light does not drift and the
Position: chemistry parameters are reasonable.
Replace the reagent and then rerun the
Chemistry:
test. Check if the reagent is sufficient
without air bubbles and the chemistry
parameters are reasonable. If yes,
replace the reagent and then rerun the
test. Check if the cuvette is normal. If
the error remains, contact our customer
17-58
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
service department or your local
distributor.
C03004 Result Warning Substrate depletion BOE The sample concentration is too high, and Check the reaction curve and the
calculation Sample ID/bar code: substrate depletion occurs during fixed-time substrate depletion limit. Rerun the test
Position: measurements. with diluted sample.
Chemistry:
C03005 Result Warning Result cannot be ENC The sample concentration is too high, and Check the reaction curve and the
calculation calculated substrate depletion occurs within the lag time of substrate depletion limit. Rerun the test
Sample ID/bar code: rate check measurements. with diluted sample.
Position:
Chemistry:
C03006 Result Warning Linearity limit out of LIN The measuring points for result calculation are Check the reaction curve and the
calculation range nonlinear, because the sample concentration is too substrate depletion limit. Rerun the test
Sample ID/bar code: high, or the substrate depletion limit is not with diluted sample.
Position: specified or unreasonable.
Chemistry:
C03007 Result Warning Prozone check error PRO Antibody excess occurs due to too high sample Check the reaction curve and the
calculation Sample ID/bar code: concentration. prozone check parameters. Rerun the
Position: test with diluted sample.
Chemistry:
17-59
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C03008 Result Warning Sample concentration is RRN The sample concentration exceeds the high limit Rerun the test with diluted sample.
calculation higher than that of the of the calibrator concentration.
highest-level calibrator
Sample ID/bar code:
Position:
Chemistry:
C03009 Result Warning Mixed blank absorbance MBK The reagent goes wrong; the cuvette is not clear; Check if the cuvette is not overflowed,
calculation out of range the reaction cuvette is overflowed; or insufficient the reagent is sufficient without air
Chemistry: reagent is dispensed. bubbles, the light does not drift and the
Calibrator: chemistry parameters are reasonable. If
yes, replace the reagent and then rerun
Position:
the test. Check if the reagent is
sufficient without air bubbles and the
chemistry parameters are reasonable.
Check if the cuvette is normal. Replace
the reagent and then rerun the test. If
the error remains, contact our customer
service department or your local
distributor.
C03010 Result Warning Blank response out of BLK The reagent goes wrong; insufficient reagent is Check if the cuvette is not overflowed,
calculation range dispensed; the cuvette contains air bubbles; the the reagent is sufficient without air
Chemistry: light drifts; or the cuvette is overflowed. bubbles, the light does not drift and the
Calibrator: chemistry parameters are reasonable. If
yes, replace the reagent and then rerun
Position:
the test. Check if the reagent is
sufficient without air bubbles and the
chemistry parameters are reasonable.
Check if the cuvette is normal. Replace
the reagent and then rerun the test. If
the error remains, contact our customer
service department or your local
17-60
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
distributor.
C03011 Result Warning Calibration repeatability DUP The difference between the maximum and Check if the acceptance limit is
calculation out of range minimum response of the calibrator exceeds the reasonable, troubleshoot the error, and
Chemistry: specified limit. then recalibrate.
Calibrator:
Position:
C03012 Result Warning Calibration sensitivity SEN The difference of final response of the maximum Check if the acceptance limit is
calculation out of range and minimum concentration calibrators exceeds reasonable and the reagent and
Chemistry: the specified limit. calibrator are normal, and then
Calibrator: recalibrate.
Position:
C03013 Result Warning Calibration curve CSD The calculated standard deviation of the Check if the acceptance limit is
calculation standard deviation out calibration curve exceeds the specified limit. reasonable and the reagent and
of range calibrator are normal, and then
Chemistry: recalibrate.
Calibrator:
Position:
C03014 Result Warning Calibration curve fitting DET The calculated fit of the calibration curve exceeds Check if the acceptance limit is
calculation out of range the specified limit. reasonable and the reagent and
Chemistry: calibrator are normal, and then
Calibrator: recalibrate.
Position:
17-61
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C03015 Result Warning Calibration slope FAC The slope difference is applicable to linear Check if the acceptance limit is
calculation different out of range calibration only and refers to the K factor (slope) reasonable and the reagent and
Chemistry: difference between two adjacent calibrations. It calibrator are normal, and then
Calibrator: exceeds the specified limit. recalibrate.
Position:
C03016 Result Warning Calibration curve not MON The calibration data and calibration curve are not Check if the calibrator is defined and
calculation monotonic monotonic. placed correctly, and then recalibrate.
Chemistry:
Calibrator:
Position:
C03017 Result Warning Calibration curve not COV For nonlinear calibration, a satisfying base cannot Check that the reagent and calibrator
calculation convergent be calculated and no calibration curve is drawn. are normal, and then recalibrate. If the
Chemistry: error remains, contact our customer
Calibrator: service department or your local
distributor.
Position:
C03018 Result Warning 12s warning 12S The QC result is between ±2 and ±3 standard No actions are required.
calculation Control: deviations from the assigned mean concentration.
Chemistry:
C03019 Result Warning 13s out of control 13s The QC result is greater than ±3 standard Check if the reagent is qualified and
calculation Control: deviations from the assigned mean concentration. control is normal. If the error remains,
Chemistry: contact our customer service
department or your local distributor.
C03020 Result Warning 22s out of control 22s Results of two controls or two results of one Check if the reagent is qualified and
calculation Control: control within a run are simultaneously greater control is normal. If the error remains,
Chemistry: than +2 or -2 standard deviations from the contact our customer service
assigned mean. department or your local distributor.
C03021 Result Warning R4s out of control R4S One result of a run is greater than +2 standard Check if the reagent is qualified and
calculation Control: deviations from the assigned mean and the other control is normal. If the error remains,
Chemistry: greater than -2SDs. contact our customer service
17-62
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
department or your local distributor.
C03022 Result Warning 41s out of control 41s Results of two runs in two-control evaluation or Check if the reagent is qualified and
calculation Control: four continuous results of a control are greater control is normal. If the error remains,
Chemistry: than +1 or -1 standard deviation from the assigned contact our customer service
mean concentration. department or your local distributor.
C03023 Result Warning 10x out of control 10x Results of five runs in two-control evaluation or Check if the reagent is qualified and
calculation Control: ten continuous results of a control that are being control is normal. If the error remains,
Chemistry: compared are on the same side. contact our customer service
department or your local distributor.
C03024 Result Error Biochemistry test period / 1. Software error Rerun the test. Reboot the operating
calculation time out. Cannot 2. Operating system error software, analyzing unit and computer.
continue If the error remains, contact our
customer service department or your
local distributor.
C03025 Result Error ISE test period time out. / 1. Software error 1. Restore the system and rerun the test.
calculation Cannot continue 2. Calculation of ISE calibration factor is time out 2. Replace the calibrator and
due to incorrect response. recalibrate.
3. Replace the electrode.
C03026 Result Warning Photoelectric data is lost / Communication error. If the error persists, contact our
calculation customer service department or your
local distributor.
17-63
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C03030 Result Error Photoelectric / 1. Software error 1. Rerun the operating software.
calculation measurement period is 2. Reboot the operation unit.
out of range 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor. 。
Chemistry:
C03031 Result Error Multiple photometric / 1. Software error 1. Rerun the operating software.
calculation measurements are time 2. Reboot the operation unit.
out 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor. 。
Chemistry:
C04001 Sample bar code Warning Sample bar code / Duplicate bar code is used. Replace the duplicate sample bar code
already exists. label.
Sample ID/bar code:
Position 1:
Position 2:
C04002 Sample bar code Warning Corresponding program / The sample of the bar code has not been Program the sample of the bar code.
information does not programmed.
exist
Sample ID/bar code:
Position:
C04006 Sample bar code Warning Sample is expired / The sample is loaded after its shelf life is The sample is expired. Replace the
Sample ID/bar code: exceeded. sample and program it again. Reject the
Position: expired sample. If the sample shelf life
is too short, change it to a reasonable
one.
17-64
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C04007 Sample bar code Warning Sample bar code / The bar code contains invalid characters rather Redefine the bar code with numbers
contains invalid than number and letter. and letters.
characters
Position:
C04008 Sample bar code Warning Sample bar code is / The bar code length is greater than the maximum Redefine the bar code with no more
longer than 27 digits value of 27 digits. than 27 digits.
Position:
C04009 Sample bar code Error Sample bar code is / The bar code length is less than the minimum Redefine the bar code with no less than
shorter than 3 digits value of 3 digits. 3 digits.
Position:
C04010 Sample bar code Error Sample bar code reader / Searched configuration parameters and the set Reconfigure the bar code reader. If the
configuration error ones do not match due to communication error, or error remains, contact our customer
failed sending of configuration instruction, or bar service department or your local
code reader failure. distributor. 。
C04011 Sample bar code Warning No bar code is detected / 1. No sample is loaded. 1. Load the samples.
in sample position 2. Sample bar code is too poor to be identified. 2. Use clear and complete sample bar
Position: 3. Sample bar code label is not applied correctly. code.
4. Sample bar code scanning window is dirty. 3. Adjust the sample bar code label to
5. Symbology, digits and check digit of sample make it face the gap on the sample cup
bar code are not set correctly. adapter.
4. Clean the sample bar code scanning
window.
5. Check if the symbology, digits and
check digit of sample bar code are set
correctly.
17-65
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C05001 Reagent bar Warning Duplicate reagent bar / Incorrect reagent or reagent bar code is being Reprint the reagent bar code, or replace
code code used, or an invalid reagent bar code is being used the reagent bottle with an invalid bar
Reagent: in a closed-reagent system. Closed-reagent bar code.
Position 1: code is aligned with closed reagents, and cannot
be used again for new reagent when a reagent is
Position 2:
exhausted.
C05002 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Print the new reagent bar code with
code information error. reagent bar code is not configured reasonably. The correct settings and check the bar code
Position: reagent bar code contains incomplete or incorrect against the settings. In the case of a
reagent information, such as expiration date, closed-reagent system, replace the
reagent volume, etc. reagent bottle, or contact the reagent
The reagent is placed in an incorrect position, e.g. supplier.
R1 on reagent carousel 2, or R2 on reagent If the reagent is placed incorrectly,
carousel 1. adjust them to the correct positions, that
is, R1 to reagent carousel 1 and R2 to
reagent carousel 2.
C05003 Reagent bar Warning Reagent bar code / Incorrect reagent bar code is being used, or Check the reagent bar code settings, or
code analysis error reagent bar code settings are incorrect. reprint the reagent bar code against the
Position: Non-closed reagent bar code is being used in a settings. In the case of a closed-reagent
closed-reagent system. The system is failed to system, contact the reagent supplier.
extract reagent information from the bar code.
17-66
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C05004 Reagent bar Error Reagent has exceeded / Reagents in a closed-reagent system are used with Replace the closed reagent. If the error
code the maximum using maximum aspirate/dispense volume and remains on the new reagent, contactIf
times exhausted. Replace the reagent bottle. the error remains on the new reagent,
Position: contact our customer service
department or your local distributor.
C05005 Reagent bar Error Reagent has been / The reagent is expired and cannot be used for Replace the reagent.
code expired. Please replace measurements.
it
Position:
C05006 Reagent bar Error Wash solution position / Reagent rather than wash solution is placed in the Reposition the reagent, or remove it
code on reagent carousel fixed wash solution position (D1, No.70) on from the fixed wash solution position.
outer ring is occupied reagent carousel outer ring.
by another reagent
Position:
C05007 Reagent bar Error Wash solution position / Reagent rather than wash solution is placed in the Reposition the reagent, or remove it
code on reagent carousel fixed wash solution position (D2, No.50) on from the fixed wash solution position.
inner ring is occupied reagent carousel inner ring.
by another reagent
Position:
C05008 Reagent bar Error Physiological saline / Reagent rather than physiological saline is placed Reposition the reagent, or remove it
code position on reagent in the fixed physiological saline position (W2, from the fixed wash solution position.
carousel outer ring is No.69) on reagent carousel 1.
occupied by another
reagent
Position:
C05009 Reagent bar Error Reagent bar code reader / Searched configuration parameters and the set Reconfigure the bar code reader. If the
code configuration error ones do not match due to communication error, or error remains, contact our customer
failed sending of configuration instruction, or bar service department or your local
code reader failure. distributor.
17-67
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C06001 Host Error LIS initialization error / Host file is damaged or does not exist. Reinstall the operating software.
communication
C06002 Host Error LIS communication / Host parameters error Re-set or modify the host
communication parameter error communication parameters.
C06003 Host Error LIS communication / Communication error If the error occurs accidentally, send or
communication error receive the instruction again. If the
error still remains, contact our customer
service department or your local
distributor.
C06004 Host Error LIS host cannot be / Abnormal network connection, or the LIS host is Check LIS connection and network
communication connected not started. cable. Check if LIS host and LIS station
can start normally.
C06005 Host Warning Sending sample results / Communication error If the error occurs accidentally, send or
communication failed. receive the instruction again. If the
error still remains, contact our customer
service department or your local
distributor.
C06006 Host Warning Sending sample / Communication error If the error occurs accidentally, send or
communication information failed. receive the instruction again. If the
error still remains, contact our customer
service department or your local
distributor.
C06007 Host Warning Inquiring sample / LIS host failure. If the error occurs accidentally, neglect
communication information failed. it. If the error occurs frequently, contact
the manufacturer of LISNeglect the
error. If the error occurs frequently,
contact the manufacturer of LIS or
contact our customer service
17-68
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
department or your local distributor.
C06008 Host Warning Downloading sample / Incorrect channel settings, or insufficient or Check and re-set the chemistry
communication failed. redundant chemistries on the LIS host. correspondence between the operating
software and the LIS host.
C07003 Light source Error Light intensity is too / 1. The lamp is not installed correctly. 1. Check if the lamp is installed
weak 2. The cuvette is contaminated. correctly.
3. The lamp is aging. 2. Perform the diluted wash procedure
4. The wash station dispenses liquid incorrectly. and then the lamp check procedure.
3. Replace the lamp.
4. Check if the wash station dispenses
liquid with correct volume to reaction
cuvettes.
5. If your attempt is failed, contact our
customer service department or your
local distributor.
17-69
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07004 Light source Warning Cuvette blank out of / 1. The cuvette is contaminated. 1. Open the reaction carousel and check
range 2. The lamp is aging. if the lamp is turned on. If it is not,
Cuvette No.: 3. The lamp is not installed correctly. rerun the operating software.
4. The wash station dispenses liquid incorrectly. 2. Check if the lamp is installed
correctly.
5. The photoelectric collection board goes wrong.
3. Perform the diluted wash procedure
and then the cuvette check procedure.
4. Replace or clean the failed cuvette.
5. Replace the lamp.
6. Check if the wash station dispenses
liquid with correct volume to reaction
cuvettes.
7. If your attempt is failed, contact our
customer service department or your
local distributor.
C07005 Light source Error Lamp is not turned on / 1. The lamp is damaged. 1. Open the reaction carousel and check
2. The lamp cable is not connected properly. if the lamp is turned on. If it is not,
3. The power board of the lamp is not connected rerun the operating software.
properly. 2. Check if the lamp cable is tightened.
4. The power supply of the analyzing unit is 3. Replace the lamp.
disconnected. 4. Check if the connect of the lamp
5. The photoelectric collection board goes wrong. power board is loose, and if necessary,
reinsert the connector.
5. If your attempt is failed, contact our
customer service department or your
local distributor.
17-70
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07006 Light source Error Light intensity is too / 1. A cuvette position has no cuvette installed. 1. Check if all cuvette positions have
strong 2. The circuit gain is too high and beyond the cuvettes installed.
measurement range. 2. Contact our customer service
department or your local distributor to
adjust the gain.Contact our customer
service department or your local
distributor to adjust the gain.
C07007 Light source Error Dark current is too high / 1. The circuit gain is too high and beyond the 3. If three continuous attempts are
Channel: measurement range. failed, contact our customer service
AD: 2. The power board of the lamp is not connected department or your local distributor.
properly.
3. The photoelectric collection board goes wrong.
C07012 Other error of Warning Storage device error. / No floppy disk or U disk is inserted. No file is Check if a U disk or floppy disk is
operation unit Cannot import data found in the floppy disk or U disk, or file error, or inserted or full. Check if the storage
file is damaged. The floppy disk or U disk is device is damaged.
locked or damaged.
C07013 Other error of Warning Storage device error. / No floppy disk or U disk is inserted. Insufficient Check if a U disk or floppy disk is
operation unit Cannot export data disk space. The floppy disk or U disk is locked or inserted or full. Check if the storage
damaged. device is damaged.
17-71
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07014 Other error of Warning Biochemistry reagent / All reagents of the reagent type for the chemistry Refill or replace the reagent.
operation unit exhausted are less than the minimum limit. All reagents of
Chemistry: the type are too little to be detected.
Position:
C07015 Other error of Error ISE buffer solution is / 1. The ISE buffer tank is empty. 1. Load the ISE buffer.
operation unit exhausted 2. The liquid level sensor of the ISE module is not 2. Reconnect the liquid level sensor of
connected. the ISE module.
3. The liquid level sensor of the ISE module goes
wrong.
C07016 Other error of Warning Insufficient reagent / Insufficient wash solution on the reagent carousel. Refill the wash solution on the reagent
operation unit probe wash solution carousel.
C07017 Other error of Warning Reagent probe wash / The wash solution on the reagent carousel is Refill the wash solution on the reagent
operation unit solution is exhausted exhausted. carousel.
C07018 Other error of Warning Insufficient sample / Insufficient sample probe wash solution. Refill the wash solution.
operation unit probe wash solution.
C07019 Other error of Warning Sample probe wash / Sample probe wash solution is exhausted Refill the wash solution.
operation unit solution is exhausted
C07020 Other error of Warning Software upgrading / Software upgrading failed. If three continuous attempts are failed,
operation unit failed If three continuous attempts are failed,
contact our customer service
department or your local distributor.
17-72
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07022 Other error of Warning Less than X tests are / All reagents of the reagent type for the chemistry Refill or replace the reagent.
operation unit left in biochemistry are less than the minimum limit. All reagents of
reagent the type are too little to be detected.
Chemistry:
Position:
C07023 Other error of Warning Calibration of one or / The calibration factors will be expired. Recalibrate the chemistries.
operation unit more chemistries will
be expired
C07027 Other error of Warning One or more calibrators / The calibrator is expired. Replace the calibrator.
operation unit will be expired
C07028 Other error of Warning One or more reagents / The reagent is expired. Replace the reagent.
operation unit will be expired
C07029 Other error of Warning Uncapping time of one / The uncapping time of the reagent pack is too Replace the reagent.
operation unit or more reagents will be long.
exceeded
C07030 ISE module Error Reference electrode is REF The reference electrode is degenerated. Replace the calibrator and recalibrate. If
invalidated the error remains, replace the reference
electrode.
C07033 Other error of Error Less than X tests are / Inventory of the ISE buffer solution is lower than Check the inventory, and if necessary,
operation unit left in ISE buffer the alarm limit. refill ISE buffer solution.
solution
17-73
17 Alarms and Troubleshooting
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
C07034 Other error of Warning Insufficient / Insufficient physiological saline. Refill the physiological saline on the
operation unit physiological saline reagent carousel.
Position:
C07035 Other error of Warning Physiological saline is / Physiological saline is exhausted. Refill the physiological saline on the
operation unit exhausted reagent carousel.
Position:
17-74
Vocabulary
Absorbance
The difference between the amount of light entering a solution (incident light) and the amount
of light passing through the solution (transmitted light) without being absorbed, to determine
the concentration of the substance in the solution.
Analyzing unit
The analyzing unit, the analyzer, determines various clinical chemistries in samples and
displays the test results. It consists of the sample handling system, reagent handling system,
reaction system, cuvette wash station, photometric system, and mixer assembly.
Auto rerun
When a result is beyond the defined range or satisfies the defined conditions, the chemistry
will be run again.
Auto serum index
When the Auto Serum Index function is enabled, the system will select the SI chemistry
automatically for serum or plasma samples. The SI chemistry will also be requested
automatically when you program routine samples manually or by using the LIS host, or
program STAT samples, or program routine samples with the default panels.
Bar code reader
Fixed laser beam scanner. It scans the bar code label on sample tubes to identify samples and
match the obtained programming information with the scanned samples.
Batch program
Batch program is to program a group of samples with identical programming information,
with the exception of the sample ID.
Blank time
Blank time refers to the period between dispensing of the second reactant (reagent or sample)
in reversed order and of the last reactant (reagent or sample).
Bottle type
Volume of the reagent bottle.
Vocabulary-1
Vocabulary
Calibration curve
A calibration curve reflects the mathematical relation between calibrator concentration and
response. It is drawn based on the obtained response and the multiple values between the
minimum and maximum concentrations of the calibrator.
Calibration factor
Calibration factor is obtained based on the equation of calibrator concentration (known) and
response (calibration math model).
Calibration math model
Calibration math model is used to calculate calibration factors and create calibration curves. It
includes single-point K factor, two-point linear, multi-point linear, Logit-Log4P, Logit-Log5P,
Exponential5P, Polynomial5P, Parabola and Spline.
Calibration trend
Calibration trend summarizes a chemistry’s calibrations during a period of time and reflect the
trends of the calibrations.
Carryover
Carryover is the interference of certain substance contained in a reagent. It can influence
measurement of another chemistry or the reaction of other mixture, resulting in inaccurate
results.
Chemistry configuration
Chemistry configuration is applicable to all chemistries other than ISE chemistry and SI, and
used to enable or disable chemistries that have been defined correctly.
Closed-reagent chemistry
Closed-reagent chemistry is run by using the reagents provided by the analyzer manufacturer.
Closed-reagent chemistries cannot be modified or deleted.
Concentrated wash
Concentrated wash is an additional cleaning procedure performed on the sample probe,
reagent probes, mixers and reaction cuvettes with the aim of eliminating carryover and
preventing stains from leaving on exterior and interior of the probes, mixers and cuvettes.
Concentrated wash solution
Concentrated wash solution is used to clean the reaction cuvettes with the aim of keeping the
reagents stable and analyzing samples with increased volume.
Critical range
An allowable result range from the perspective of clinical diagnosis. If the test result is
beyond the critical range, the patient may need immediate treatment. You may enable the auto
rerun function for a chemistry, which will be rerun automatically once the test result is beyond
the critical range.
Current results
Current results include those that are in Incomplete status until the current system time and
those programmed and analyzed on the current day.
Vocabulary-2
Vocabulary
Vocabulary-3
Vocabulary
Increased
Increased indicates the sample volume required for analysis and can be defined on the
Define/Edit Chemistries window.
Initialization
Initialization is a series of operations automatically performed by the system during the
startup procedure. It includes parameters check, reset, testing, cleaning and priming.
Inventory check
Used to check the remaining volume of the biochemistry reagents, sample probe wash
solution and reagent probe wash solution and refresh the tests left and wash solution volume
on the Reagent/Calibration screen.
ISE
ISE is the abbreviation of Ion Selective Electrode. It consists of the Na electrode, K electrode,
Cl electrode, reference electrode, sampling and measuring channel, syringe, heat stabilizer,
degassing unit and waste discharger. The ISE module measures the concentration of Na, K
and Cl in serum, plasma and diluted urine.
K factor
Vocabulary-4
Vocabulary
Mask/Unmask chemistries
Used when a chemistry needs to be disabled temporarily due to abnormal result or reagent
exhaustion. The marked chemistry will have a symbol appearing on its upper-left corner,
and will still be displayed on the Sample, Control and Reagent/Calibration screens but
not run for sample analysis. Masked chemistries cannot be requested until they are unmasked.
Mixer
The system provides sample mixers and reagent mixers, which stir the mixture inside a
reaction cuvette when sample/R3 and R2/R4 are respectively dispensed.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the Current Results
and History Results screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
Offset
Offset is a value added or subtracted to compensate a result. It is often used along with the
slop in the equation y=kx+b, in which k is the slope and b is the offset.
Online help
Online help provides you with help information about the screens. If you do not understand a
parameter or an operation on a screen, you can go to the online help for relevant information.
Access the online help from the following screens:
• Select the icon on the upper right corner to display the help topic related to the
current screen.
• Select the button in front of each maintenance instruction or item to display the
relevant operating instructions.
• Select the button in front of each error log to display the corresponding topic.
Vocabulary-5
Vocabulary
Panel
Consists of a couple of chemistries combined together for certain clinical purposes, such as
liver function, kidney function, etc. Panels can help fast programming of samples.
Patient demographics
Patient demographics contain information related to the patient and sample, such as patient
name, age, gender, collection date/time, etc.
Physiological saline
0.9% sodium chloride solution, used for reagent blank and sample dilution.
Predilution
Prior to analysis, samples are diluted automatically based on the defined dilution factor.
Primary wavelength
The primary wavelength is chosen based on the light absorption features of the reactant and
used to measure the absorbed light intensity. Options for primary wavelength include: 340nm,
380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm
Prime
Prime is an action to replace the reagents in tubing of the ISE module. A prime is required to
replace the reagents in tubing with new ones during the startup procedure or when a reagent is
changed.
Print name
Print name appears on a patient report representing a chemistry, and if left blank, will be
replaced by the short name of the chemistry.
Prozone check
Prozone check is intended to checking samples with quite different concentrations, which may
generate the equivalent amount of insoluble antigen/antibody compound and can have the
same test results. The Prozone check can be performed in two ways: rate check and antigen
addition.
Pull-down list
A control of the software screen or window. Select the down-triangle button on the right of a
pull-down list to show multiple options.
QC panel
Used for analysis of control samples.
QC rule
A set of rules to evaluate if the QC results are under control and the analyzing system is stable.
Examples of QC rule are 1-2s, 1-3s, etc.
QC summary
Contains the mean values and standard deviations of controls analyzed within the specified
period, as well as the set mean and SD value. The obtained results are compared with the set
values to judge if the system is working normally.
Vocabulary-6
Vocabulary
Qualitative analysis
Qualitative analysis is used to analyze every sample for the detection of lipemia, hemolysis
and icterus and calculate the numeric values of the index. If the volume of the interferents
contained in a sample is beyond the set range, a flag will be added to the patient report.
Random error
An alarm of quality control monitoring. A random error may occur when the lowest and
highest values of QC results respectively exceed -2SD/-3SD and +2SD/+3SD.
Reaction carousel
Reaction carousel is a turntable, and used to hold reaction cuvettes and transmit each of them
to the photometric position for signal detecting and absorbance calculation.
Reaction curve
A reaction curve reflects the relationship of the absorbance measured at the primary
wavelength, secondary wavelength and primary-secondary wavelength. It is drawn based on
the absorbance of the sample-reagent mixture measured within the reaction period. The
system provides 4 types of reaction curves: calibration reaction curve, QC reaction curve,
sample blank reaction curve, and sample reaction curve.
Reaction cuvette
Reaction cuvette is a carrier in which reagents and samples react with each other and then
carried to the photoelectric position for signal detecting and response calculation.
Reaction direction
Reaction direction refers to the change trend of absorbance during the reaction process. It
includes positive and negative.
Reaction time
For endpoint analysis, the reaction time refers to the time span from the start point of the
reaction to the end point; for fixed-time and Kinetic analysis, it refers to the period from
reaction equilibrium to the end of monitoring.
Reagent blank
In the reagent blank test, the reagents react with the physiological saline, and the blank
absorbance is calculated to correct the calibration factors. Only the reagents that are in
Calibrated, Cal Time Out or Cal Required status can be requested for reagent blank.
Reagent bottle set
A logic combination of all reagent types that are probably used by a chemistry and contain
one bottle for each reagent type.
Reagent carousel
The reagent carousel is located on left side of the analyzer panel. It holds reagent bottles and
carries each of them to the reagent aspirate position for aspirating.
Vocabulary-7
Vocabulary
Reagent carryover
Cross contamination between the reagent probes and the mixers. When the number of tests
between the contaminating chemistry and the contaminated is less than or equal to the defined
N, and no concentrated wash is inserted between the two chemistries, it indicates that the
reagents underlie the risk of carryover.
Reagent inventory alarm limit
Alarm limit of reagents and wash solutions. When the reagent inventory is lower than the
alarm limits during or before the analysis, the system will give an alarm and display the
reagent or wash solution name in yellow on the Reagent/Calibration screen.
Reagent load button
The reagent load button located on the lower-right corner of the reagent carousel is used to
rotate the reagent carousel. There are two reagent load buttons available, the left one for the
inner ring and the right one for the outer ring. When the reagent load button is pressed, the
corresponding ring will rotate counterclockwise for 1/4 circle.
Reagent probe
The reagent probe aspirates the specified amount of reagent from a reagent bottle and then
dispenses it into a cuvette for reaction and analysis. The system has two reagent probes: probe
R1 and probe R2. The former is used to aspirate/dispense R1 and R3 reagents, and the latter to
aspirate/dispense R2 and R4 reagents.
Reagent probe wash solution
Used for cleaning the two reagent probes. Wash 1 and 2, placed respectively on outer ring and
inner ring of the reagent carousel, are used to clean reagent probe 1 and 2.
Reference range
Reference range is a user-defined range consisting of low limit and high limit. When a result
is beyond the reference range, a flag will appear near the result.
Release
Used to clear the specified sample position or all positions on the current sample carousel.
When a sample is released, its results and programming information can be still recalled. The
released position can be used for programming of new samples.
Replicates
Number of times to run a test, to ensure accurate results.
RMS
RMS is the short form of Remote Maintenance System. It provides a platform of remote
diagnosis and maintenance based on the internet. The RMS allows transfer of data and files
with the chemistry analyzers in hospitals, and helps the service engineers to find, collect,
analyze, locate and solve the failures happening at the user end.
Sample blank
Sample blank is similar to sample analysis except for use of equivalent amount of
physiological saline. Sample blank is used for removal of non-chromogenesis reaction, such
as influence of sample interference (Hemolysis, icterus and lipemia) on absorbance readings.
Vocabulary-8
Vocabulary
Sample carousel
The sample carousel is located on right side of the analyzer panel. It holds sample tubes and
carries each of them to the sample aspirate position for aspirating.
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; ** sample needs to be
analyzed immediately, etc.
Sample load button
The sample load button located on the lower-right corner of the sample carousel indicates the
rotating status of the sample carousel and controls its rotating action. There are two sample
load buttons available, the left one for the inner carousel and the right one for the outer
carousel.
Sample log
Contains the controls and patient samples that are not complete within the recent 24 hours due
to certain reasons. Based on the sample log you are allowed to rerun the samples or take other
actions for the controls and samples.
Sample panel
Used for analysis of patient samples.
Sample probe
The sample probe aspirates the specified amount of sample from a sample tube and then
dispenses it into a cuvette for reaction and analysis.
Sample probe wash solution
Used to clean the sample probe and located in position D3 of the analyzer’s front panel.
Sample type
Type of sample. The sample type options include serum, plasma, urine, CSF and other.
Screen
Screen is a part of the software interface. It is rectangular and contains various controls, such
as edit box, function button, etc.
Secondary wavelength
The secondary wavelength is used to remove the interference in primary wavelength values
and eliminate the influence of noise, such as light flash and drift, and scratches on cuvettes,
etc. It cannot be the same as the primary wavelength.
Serial number
Sequence number of the reagent bottle.
Slope
Multiplied with the test result to make it consistent with that obtained on other instruments. It
is often used along with the offset in the equation y=kx+b, in which k is the slope and b is the
offset.
Vocabulary-9
Vocabulary
Special calculation
Special calculation is derived from calculation of certain chemistries and has specific clinical
purposes, such as A/G, TBil-DBil, etc.
Standard deviation (SD)
Standard deviation is the mean of deviations from the mean value. It is an index to judge the
measurement accuracy under specific conditions. In this manual, SD refers to the standard
deviation of control concentration.
Standby
Standby is one of the system statuses. When the system status is Standby, it indicates that all
tests are finished and all actions of the system have stopped.
STAT
STAT means emergent, including common STAT and quick STAT program. STAT sample
program allows emergent samples to be programmed and analyzed with high priority.
Common STAT program is used in daytime to run emergent samples with higher priority than
routine samples. Quick STAT program is mainly used in nighttime and weekends to program
emergent samples quickly with higher priority than routine and common STAT samples.
Symbology
Symbology is a set of rules for encoding and decoding information contained in a bar code
label. The system provides a couple of symbologies, such as Codabar, ITF, code128, code39,
UPC/EAN, and Code93.
Systematic error
An alarm of quality control monitoring. A systematic error may occur when both the lowest
value and highest value of a QC result are on the same side.
Transmit
Transmit is an action sending specified sample results or QC results to the LIS host.
Twin-Plot chart
A twin-plot chart, drawn based on the results of control X and control Y in the same run, is
used to detect systematic errors and random errors. It shows the recent 10 QC results of a
chemistry and excludes those that have been deleted.
Two-control evaluation
In two-control evaluation, two results are obtained: Xn and Yn, which are used to define a
point on the Twin-plot chart. In this way, a complete twin-plot chart is drawn based on all the
QC results and used for detecting systematic errors and random errors.
Vocabulary-10
Vocabulary
Unpositioned samples
Samples without positions assigned or with positions not assigned successfully, including
those:
• downloaded from the LIS host and not positioned yet.
• that are in Incomplete status when their positions are assigned for new samples.
• that are incomplete when their positions are released.
Westgard rule
Westgard rule is used for monitoring of quality control. In the Westgard rule, single rules such
as 12S, 13S, 22S and 41S are combined to evaluate results of single or multiple controls.
Vocabulary-11
Vocabulary
Vocabulary-12
Index
A D
absorbance, 4-2
Daily maintenance, 16-17
Adding chemistries, 13-13
Default panel, 8-23, 10-1, 10-12, 13-4, 13-8, 1
Antigen addition, 3-20, 4-13, 6
Defining a chemistry, 3-10, 6-7
Antigen excess, 3-20, 4-13, 4-14
Delete/edit logs, 9-38, 9-39, 17-1, 17-7, 17-8
Auto calibration, 2-25, 3-31, 6-1, 6-12, 6-13, 6-14
Dispenser assembly, 1-8, 1-11, 1-14, 1-16, 1-17
Auto quality control, 2-30, 7-6
Dust screens, 16-5, 16-10, 16-48, 16-49, 16-50
Auto rerun, 3-9, 3-18, 3-21, 3-23, 3-25, 8-3, 8-8, 8-9, 8-10, 2
Auto serum index, 3-3
Auto sleep and startup, 3-4, 11-1 E
endpoint, 4-2
B Endpoint measurements, 4-2, 4-3, 4-4, 3
Equilibrium, 4-4
Biochemistry maintenance, 16-6, 16-7
Error detection limits, 3-9, 3-10, 3-17
Blank time, 2-23, 3-15, 3-16, 3-20, 4-6, 4-8
Error logs, 1-32, 9-38, 9-39, 11-2, 12-34, 17-1, 17-6, 17-7,
17-8, 17-10, 17-11, 17-12
C External air pump, 15, 1-29, 1-47
calibration curve, 4-11, 4-12
Calibration math model, 3-31, 4-11, 4-12, 2 F
Calibration reports, 3-32
Filter core, 16-5, 16-10, 16-45, 16-46, 16-47, 16-57
Calibration rules, 2-23, 3-26, 3-30
Fixed-time measurements, 4-4, 4-5, 3, 4
Calibration status, 2-7, 2-10, 2-24, 2-47, 6-1, 6-2, 6-6, 6-7,
6-8, 6-12, 6-13, 6-14, 6-20, 8-33, 8-36, 9-17, 12-18, 12-19
Calibration trends, 6-12, 6-16, 6-25, 12-17, 12-25, 12-26 H
calibrator, 4-11 High-concentration waste, 1-21, 2-1, 2-3, 2-51, 16-23
Calibrator acceptance limits, 3-26 Host communication, 3-8, 14-1, 17-4
Chemistries left, 2-10, 2-13, 2-47, 2-48, 9-17
Chemistry list, 2-28, 3-9, 3-10, 3-11, 8-1, 8-36, 9-12, 9-17,
9-18, 9-19, 10-10
I
Closed-reagent chemistry, 5-7, 5 Installation requirements, 1-1
Concentrated wash solution, 3, 4, 2-17, 2-18, 5-15, 15-1, Instrument status reports, 9-32
16-17, 16-24, 16-30, 16-31, 16-80, 16-83, 16-86, 16-87 ISE chemistry parameters, 12-4, 12-5, 12-7
Control status, 7-2 ISE maintenance, 16-7, 16-8
Critical range, 3-11, 3-23, 3-24, 3-25, 8-3, 8-8, 8-9, 2 ISE module, 8, 1-25, 1-26, 1-31, 2-8, 2-23, 3-4, 3-6, 10-8,
Current results, 8-38, 13-14 10-10, 11-1, 11-10, 12-1, 12-2, 12-4, 12-7, 12-13, 12-14,
Cuvette wash station, 1-20, 1-21, 16-44, 1, 3 12-16, 12-31, 12-33, 12-34, 15-2, 16-4, 16-7, 16-8, 16-17,
16-25, 16-40, 16-88, 16-89, 16-90, 16-92, 16-93, 16-94,
Index-1
Index
16-95, 16-96, 17-3, 17-5, 4, 6 Reaction time, 2-23, 3-15, 3-16, 3-18, 3-20, 4-2, 4-6, 4-7, 4-8,
ISE startup primes, 3-2, 3-4 4-10, 4-14, 7
Reagent blank, 1-9, 2-21, 3-19, 4-10, 6-1, 6-6, 6-7, 6-8, 6-9,
K 6-10, 6-17, 6, 7
Reagent bottle set, 5-1, 5-7, 5-8, 5-9
Kinetic, 4-6 Reagent handling system, 1-13, 1-45, 1
Reagent inventory alarm limit, 3-4, 5-1
L Reagent load button, 1-15, 2-16, 2-17, 2-19, 2-22, 5-11, 5-12,
5-13, 5-14, 13-19, 8
Linearity range, 3-18, 4-6, 4-7, 4-8, 4-9, 4-10, 8-3, 8-9, 8-10, Reagent reports, 9-17
8-49 Reagent volume, 8, 2-23, 3-17, 3-20, 8-22
L-J chart, 7-8, 7-11, 7-12, 9-26, 9-27, 4 Reference range flags, 3-2, 3-25
Low-concentration waste, 1-21, 2-3, 16-24 Reference/critical range, 3-23, 3-25, 3-26
Remote maintenance system (RMS), 1-27
M response, 4-11, 4-12
Results recall, 12-28
Measuring point, 4-5, 4-6, 4-7, 4-9
Mixed blank absorbance range, 6-7
Mixer assembly, 1-22, 1-23, 1-24, 1-46, 16-6, 1 S
Multi-sample report, 9-10, 11-2 Sample blank, 9, 3-16, 4-4, 4-5, 6-21, 7-10, 7-16, 8-16, 8-17,
8-43, 9-9, 9-15, 9-16, 7
N Sample blanked response, 4-4
Sample comments, 2-31, 3-4, 3-5, 8-31
Non-linear calibrations, 3-33, 4-10
Sample handling system, 1-8, 1-45, 15-1, 1
Sample injection cup, 16-5, 16-11, 16-88, 16-89, 16-90,
O 16-93
Off-line dilution, 2-33, 2-35, 2-41, 2-43, 8-15 Sample injection port (SIC), 15-2, 16-89, 16-94
Off-line load of reagents, 5-11 Sample list, 2-29, 2-39, 7-8, 7-10, 8-33, 8-34, 8-40, 8-44,
On-line load of reagents, 5-10 8-50, 8-51, 9-9, 9-11
Sample load button, 1-10, 8-19, 8-20, 9
Sample logs, 8-29, 8-31
P Sample status, 8-30, 8-33, 8-34, 8-35
Physiological saline, 1-9, 1-14, 2-13, 3-4, 3-16, 5-9, 8-16, Screen operation logs, 17-1
12-31, 13-18, 7, 8 Single-point linear calibration, 4-10, 4
Powering off, 2-2, 16-94, 16-95 Software version, 3-4, 3-6, 11-10, 16-9
Powering on, 2-1, 2-4 Special calculation, 10-3
Print name, 3-13, 8-22, 10-3, 12-6 Substrate, 4-4, 4-5, 4-6, 4-7
Print setup, 9-1 Substrate depletion, 3-18, 3-19, 4-5, 4-6, 4-7, 4-8, 4-10
Processing parameters, 3-10, 3-11 Symbology, 13-2, 13-3, 13-17
Syringe plunger assembly, 8, 16-2, 16-3, 16-10, 16-51
Systematic error, 7-2, 7-3, 7-4, 7-5, 7-12, 10
Q
QC alarms, 7-2 T
QC reports, 7-2, 9-26, 11-2
QC rules, 3-34, 3-38, 7-1 Technical parameters, 1-22
temperature, 4-2
Twin-Plot chart, 9-28, 9-29, 10
R Two-control evaluation, 3-38, 3-39, 7-5, 7-6, 9-28, 10
Random error, 7-2, 7-3, 7-4, 7-5, 7-12, 7, 10
Reaction direction, 2-23
Reaction system, 1-19, 1-46, 1
Index-2
Index
Index-3
Index
Index-4
P/N: 046-001049-00(2.0)