1 - 【Operation Manual】A8 Instruction for Users

ACCRE8
Automatic Chemiluminescence Immunoassay (CLIA)

Analyzer
INSTRUCTION FOR USER
Shenzhen Tisenc Medical Devices Co., Ltd
IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 1

Instruction for User PREFACE
PREFACE
Please read the instruction for users carefully before using.
Please keep this manual carefully after reading so that you can check it whenever you need it.
Product Information
Product Name: Automatic Chemiluminescence Analyzer
Model Specification: ACCRE 8
Intend Use: The ACCRE 8 system is clinically used for the quantitative or qualitative
determination of concentrations of analyte, including hormones, vitamins, cardiac markers, and
inflammation markers, in serum, plasma, whole blood and other human body fluids. The product
uses indirect chemiluminescence method based on substrate and alkaline phosphatase with the
supporting reagents cartridge.
System Components:
The instrument is mainly composed of material equipped module, sample loading module,
temperature control module, mechanical drive module, optical detection module, circuit control
module and software system.
License Number:
Medical Device Registration Certificate Number / Product Technical Requirements Number:
Registrant / Production Enterprise: Shenzhen Tisenc Medical Devices Co., Ltd.
Address/Production Address: F, 10th Floor, G, 11th Floor, F, 11th Floor, G, 10th Floor, Science
and Technology Innovation Park, Houting, Maozhoushan Industrial Park, Shajing Street, Bao'an
District, Shenzhen
Post Code: 518104
Tel: 0755-36983631
Production date: See the instrument host label for details.
Use period: 10 years
Date of preparation: 2018.06
Instruction information
Manual version: 1.0
Software release version: V1.0
Intellectual property
Shenzhen Tisenc Medical Devices Co., Ltd. owns the copyright of the non-public publication
instrument for users and has the right to treat it as confidential file. This manual is intended only
as a reference for the operation, maintenance and repair of the product. This manual and all its
intellectual property rights (including copyright) belong to Shenzhen Tisenc Medical Devices Co.,
Ltd.
Anybody can’t use, disclose or permit others to obtain all or part of the information in this
manual, including, but not only, filming or copying or translating all or part of this manual without
the prior written permission of Tisenc.
Statement
This instrument only can be used together with the supporting reagents produced by Tisenc.
The product is only allowed for in vitro diagnostics for human. The product has specific use
rights, and its general patents and licenses. Purchase of this product only has the right to use within
the regulations, and does not allow any other general patents and licenses beyond the right to
using. This product cannot be used in production scientific research and development, patient self-
determination, drug development, or in any veterinary, food, water, environmental testing or other
field.
Shenzhen Tisenc Medical Devices Co., Ltd. is only responsible for the safety, reliability and
performance of this instrument under the following conditions:
1) Assembly operations, expansion, re-adjustment, improvement and repair are carried out by
personnel approved by Shenzhen Tisenc Medical Devices Co., Ltd.

2) The instrument is operated until it is used.

3) The relevant electrical equipment complies with national standards.
Tisenc is not responsible for the safety, reliability and operation of the product if:
1) The product has exceeded the end of life.
2) The components are disassembled, stretched, and re-commissioned.
3) The product is not used correctly in accordance with the "Instruction for Users".
4) The system is not working properly or produces incorrect results due to using of reagents
not from Tisenc (or expired reagents) or fails to follow the rules.
Warranty and repair services

The warranty period of this product is subject to the sales contract.
The warranty period begins with the “installation date” on the “warranty card” with this
product. The “warranty card” is the only certificate for calculating the warranty period. In order to
protect your rights and interests, please fill in the warranty card after the installation of the
equipment, and hand over the warranty card to the installer or mail it back to Tisenc’s customer
service department.
The following conditions will not be covered by the warranty:
1) The customer has not filled in and returned the ”warranty card” within 30 days of the
completion of the installation acceptance.
2) The serial number of the equipment provided by the customer is incorrect (our company
confirms the warranty by the serial number of the equipment).
During the warranty period, the products can enjoy free after-sales service, but if due to the
following reasons, the company needs to repair the situation, the company will implement a fee-
based repair service, and customers need to pay maintenance and accessories costs.
1) man-made damage;
2) Improper use or misuse
3) The grid voltage exceeds the specified range of the product;
4) Irresistible natural disasters;
5) Unauthorized repair or parts replacement;
6) Other failures caused by non-products themselves;
7) After the expiration of the warranty period, the company can continue to provide fee-
based services;
If you do not pay or delay the payment of the repair service fee, Shenzhen Tianshen Medical
Devices Co., Ltd. will temporarily suspend the repair service until you pay.
After-sales service department

Shenzhen Tisenc Medical Devices Co., Ltd.
Address: 10F、10G、11F、11G, Kechuang Building, Quanzhi Science and Innovation Park,
Maozhoushan Industrial Park, Shajing Community, BaoAn District, Shenzhen,518104，P.R.China
Post Code: 518104
Tel: 0755-36983631
Website: www.tisenc.com
E-mail: tisenc@tisenc.com
24-hour Phone: 400-6125606
Contact Information
Shenzhen Tisenc Medical Devices Co., Ltd.

Address: 10F 、 10G 、 11F 、 11G, Kechuang Building, Quanzhi Science and Innovation
Park,Maozhoushan Industrial Park,Shajing Community, BaoAn District, Shenzhen,518104 P.R.China
Phone: 400-6125606

E-mail:support@tiesnc.com
Shanghai International Holding Corp. GmbH (Europe)

Address: Eiffestrasse 80, 20537 Hamburg Germany
Phone: +49-40-2513175
Fax: +49-40-255726

Instruction for User Chapter 1 SAFTY NOTE
CONTENT
PREFACE......................................................................................................................................2
Product Information ...............................................................................................................2
Instruction information ..........................................................................................................2
Intellectual property ...............................................................................................................2
Statement ...............................................................................................................................2
Warranty and repair services .................................................................................................3
After-sales service department ..............................................................................................3
Chapter 1 SAFTY NOTE ...............................................................................................................7
1-1 Safety Symbols .................................................................................................................7
1-2 General Symbols...............................................................................................................8
1-3 Safety Note for Installation ..............................................................................................8
1-4 Safety Note for Users .................................................................................................... 10
Chapter 2 INTRODUCTION OF SYSTEM ................................................................................... 14
2-1 Checking before using ................................................................................................... 14
2-2 Packing List .................................................................................................................... 14
2-3 System Features ............................................................................................................ 16
2-4 System Specifications: ................................................................................................... 16
2-5 System Performance ..................................................................................................... 17
2-6 EMC ............................................................................................................................... 17
2-7 System Overview ........................................................................................................... 18
2-8 System Consumables..................................................................................................... 22
2-9 Reagent Introduction .................................................................................................... 23
Chapter 3 PRINCIPLE................................................................................................................ 26
3-1 Assay principle: CLEIA (Enzyme catalytic chemiluminescence immunoassay) ............. 26
3-2 Assay Procedure ............................................................................................................ 27
3-3 Introduction of PMT signal reading ............................................................................... 27
Chapter 4 SOFTWARE OPREATION .......................................................................................... 28
4-1 Work with Touch Screen ............................................................................................... 28
4-2 Start the analyzer .......................................................................................................... 28
4-3 Software operation ....................................................................................................... 28
4-4 Software Main Menu .................................................................................................... 29
Chapter 5 SOFTWARE-SETTING MENU.................................................................................... 30
5-1 Summary of SETTING Menu .......................................................................................... 30
5-2 Calibration Setting ......................................................................................................... 30

5-3 QC Setting ...................................................................................................................... 31

5-4 Assay Setting ................................................................................................................. 32
5-5 General Setting .............................................................................................................. 33
Chapter 6 Software- CALIBRATION.......................................................................................... 37
6-1 CALIBRATION ................................................................................................................. 37
6-2 Start the CALIBRATION .................................................................................................. 40
6-3 Result of Calibration ...................................................................................................... 40
6-4 Discard the used reagent and tips................................................................................. 41
Chapter 7 Software- QC........................................................................................................... 42
7-1 QC Test .......................................................................................................................... 42
7-2 Preparation of QC test................................................................................................... 42
7.3 QC test .......... 46
7.4 Output the QC test result .............................................................................................. 46
7.5 Discard the used reagent and tips ................................................................................. 46
Chapter 8 Software-Test Menu ........................................................................................... - 48 -
8-1 Sample test ................................................................................................................ - 48 -
8-2 Sample test ................................................................................................................ - 53 -
8-3 Print out sample test results ..................................................................................... - 53 -
8-4 Dispose used reagents cartridge and used tips......................................................... - 53 -
Chapter 9 SOFTWARE- SERACH MENU................................................................................ - 54 -
9-1 SEARCH ...................................................................................................................... - 54 -
9-2 Search the CALIBRATION result................................................................................. - 54 -
9-3 Search the Sample Test Result .................................................................................. - 55 -
9-4 Search the QC result .................................................................................................. - 56 -
9-5 About ......................................................................................................................... - 56 -
Chapter 10 MAINTENANCE ................................................................................................. - 58 -
10-1 Purpose of Maintenance ......................................................................................... - 58 -
10-2 User’s Maintenance Procedure ............................................................................... - 58 -
10-3 Replace the Paper of Thermo-Printer ..................................................................... - 58 -
Chapter 11 Error Messages and Trouble shooting .............................................................. - 60 -
11-1 Table Error Messages and Resolution ..................................................................... - 61 -

Chapter 1 SAFTY NOTE

It is essential that the warnings, cautions and safety requirements contained in this manual
are read and understood by the user before operating the system. Warning symbols have been
placed on the system to draw your attention to areas of potential hazards.
1-1 Safety Symbols
The following table defines safety symbols that may appear in the instructions for users or on
the instruments. When surrounded by a triangle on a yellow background, the symbol highlights an
immediate warning and is positioned on the instrument itself. Safety symbols have been placed on
the system to draw your attention to areas of potential hazards.
Please read the below description of safety symbol carefully
Safety Symbol Description
Potential Danger that can cause death or
serious deterioration of the state of health of the
User. Read Operating Instruction thoroughly
Electric shock warning
Laser beam
Danger of Acid Liquids
Biological risks

1-2 General Symbols

The following table defines general symbols that may appear in the instructions for users,
package insert, or labels.
Symbol Description
Manufacturer
Authorized Representative in the

European Community
Date of manufacture
Shelf life ,Use by Date
Lot Number, Batch code of each lot of

reagent or calibrator or QC
Catalog number
Serial Number
Temperature limitations
Consult Instructions for Users
Caution, consult accompanying documents
For In-Vitro Diagnostic Use Only
1-3 Safety Note for Installation

1-3-1 Environment Requirements for installation
Please contact authorized representative or service engineer for the unpacking and installation
of ACCRE-6 analyzer.
Temperature: 10-30℃
Humidity: < 70% (at environment temperature 30℃ ), No condensate water
Pressure atmosphere: 70-101KPa
Please note that the analyzer can only be used indoor
Please ensure enough space room for the installation of analyzer
Please place the analyzer in a flattening operating platform
Do not expose the analyzer to direct sunlight, and keep the analyzer away from the air
conditioner.
Do not block the air vent at the back of the analyzer, and make sure there is no object to block
the air flow around the air vent.

Make sure the analyzer is placed in a position where it is easy to operate the device.
1-3-2 Electrical Requirements

Voltage: AC 220V
Frequency: 50Hz
Power: 300W
1-3-3 Storage and Transportation Requirement:
For Storage:
Temperature: 5-45 ℃
Humidity: ≤70% (at environment temperature 30℃ )
For Transportation:
Temperature: -20 - 55 ℃
Humidity: ≤90% (at environment temperature 40℃ )
Package Size:
Length: 773mm
Width: 529mm
Height: 658mm
Symbols on the package:
Keep Up Straight Keep Dry Fragile
Do Not Turn Over Do Not Pile

1-3-4 Standards compliant
The analyzer is compatible with the following standards. The analyzer was manufactured,
verified and transported out of the factory according to the original safety standards. Equipment is
approved for use by public agencies.
Applied Standards:
IEC 61010:2010 Safety of electrical equipment for measurement, control and laboratory use -
- Part 1 : General requirements
IEC 61010-2-010:2014 Safety of electrical equipment for measurement, control and
laboratory use -- Part 2-010: Particular requirements for laboratory equipment for heating of
materials
IEC 61010-2-101:2018 Safety of electrical equipment for measurement, control and
laboratory use -- Part 2-101: Particular requirements for laboratory diagnostic (IVD) medical
equipment
IEC 61010-2-081:2015 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
IEC 61326-1:2012 Medical devices. Part 1:Application of usability engineering to medical

devices
IEC 61326-2-6:2012 Electrical Equipment for Measurement, control and laboratory use -
Electromagnetic Compatibility - Part 2-6: Particular Requirements - Diagnostic (IVD) Medical
Equipment under Laboratory Conditions
Symbol
1-4 Safety Note for Users

1-4-1 Electromagnetic radiation interference:
Those equipments that may generate strong electromagnetic radiation can interfere with the
work of the analyzer. Interference can be reduced by using the power cable sent with the analyzer.
Please note that unauthorized personnel can’t carry out maintenance or service operations. There
is no guarantee that the instrument will not cause electromagnetic interference to other devices
at all. If other devices such as TVs and radios have improved performance after turning off the
instrument, it generally means that the instrument is the source of interference.
Unauthorized personnel are not allowed to perform maintenance operations. There is no
guarantee that the analyzer is completely free from interference from other devices. When the
possible sources of interference are turned off and the analyzer is improved, the presence of the
source of interference is indicated. Try the following:
▶ Keep the analyzer away from interference devices.
▶Replace the power outlet and use a different line than the interference device.
▶Learn about the status of other devices connected to the instrument but not disturbed.
1-4-2 General Note for Users

Please use the analyzers and reagents provided by Tisenc
Please follow the instruction for users, storage and transportation in the instruction for users
and package insert.
Please turn on the analyzer and wait for 30 minutes before running the test to allow the
electronic devices and temperature in stable condition
Please comply with temperature and time regulations of the reagent manufacturer.
Please seal tightly the waste bag for biohazard
Avoid bubbles when pipetting sample into the reagent cartridge because bubbles may
influence the test result.
DO NOT remove the reagent cartridge before the analyzer finishes the test.
Keep the instrument dry and avoid spill any liquid. If it is accidentally dripped, please dry it
immediately.
If the instrument fails, please do not disassemble and repair it. Please report the administrator
in time to inform the professional maintenance personnel.
1-4-3 Safety Principle

Intended use: Please note that the analyzer is for In Vitro Diagnostic use only, and it can work
only with the reagent provided by Tisenc.
General Safety notice: Please notice the warning symbol for precautions and safety use, and
follow the instruction for users carefully. For safety purpose, do not change the setting of analyzer
including changing of any parts or removing of any safety precautions.

1-4-4 Warning and Precautions (for analyzer)
Danger, do not touch the electronic part, risk for electronic shock
and short circuit.
Danger, do not change the setting of the analyzer
Danger, unplug the power cable and shut off the analyzer in
emergency situation, contact your local representative immediately
Inappropriate operation of analyzer when analyzer is electrified will
damage the analyzer.
Turn off the analyzer before removing the power plug
Please follow the manufacturer’s instruction and regulation when

changing the fuse on the analyzer, inappropriate using of fuse or
unqualified fuse will cause damage to analyzer
Unplug the analyzer immediately if there is any liquid splash into the
analyzer, then call the technical service.
The analyzer comply with EMC regulations, but please note that the
radiation released by high power electronic device still cannot be block.
Do not use high power wireless or cellphone close by the analyzer.
Do not press more than one button at a time, because this operation
will cause damage to analyzer
Please note that ACCRE-6 is the IVD analyzer using serum, plasma or
whole blood as sample, and do not test the analyzer for other purpose
1-4-5 Warning and Precautions (for reagent)
Please note that ACCRE-6 system is a close system, only reagents
provided by Tisenc can be used on ACCRE-6 system, and follow the
instruction for users and package insert carefully when using the System
Do not use the expired reagent
Do not touch the black reading cup on the reagent cartridge and the
aluminum film of the cartridge with hand when performance the test and
carrying the cartridge by the handle.
Do not turn over or shake the reagent cartridge violently, because
this operation could influence the test result
Please store the reagent cartridge following the instruction of
package insert
Handle reagent cartridge gently when loading to the reagent rack,
and make sure the cartridge is loaded tighten on the rack.
Incubate the reagent at room temperature when being taken out of

the fridge before using, and do not use the reagent cartridge immediately
after being taken out of fridge.

1-4-6 Warning and Precautions (for operator)
Please note that operation of the analyzer is for authorized

professional only
Please contact authorized representative or technical service for the

service of analyzer.
Do not put your hand into the analyzer when analyzer is running.
Please wear protective equipment (glove, mask, lab coat and etc)
when operating the analyzer.
Be careful not to get scratched when replacing the printing paper.
The ethanol used to clean the analyzer is flammable, and please

handle with precautions
Please note that cleaning and sterilization can only be perform
when analyzer is not running, and Do NOT proceed when analyzer is on
Avoid the direct contact with eyes to the laser beam of the bar code
reader, and the laser beam may damage the eyes
Avoid the direct contact with skin to the substrate, and direct
contact may cause chemical burn
Keep the door closed when the analyzer is on
1-4-7 Handling the disposal

Please note that follow the security protocol of laboratory waste like
<Biosafety in Microbiological Laboratories> or < CLSI Document M29-T >
when proceeding the sample.
Please follow the local security precaution and regulation when

handling the disposal
1-4-8 Notice for maintenance and service

1> Please follow the instruction of users for the maintenance of the analyzer. If
working hour is more than averagely 8 hours per day, then please consider to increase
the frequency of maintenance.
2>Follow the instruction of users for the trouble shooting and service
3>Do not open the analyzer’s shell or try to replace the part of analyzer without
the authorized technical service of Tisenc at present, and please contact authorized
representative or Tisenc for service.
1-4-9 Cleaning and disinfection
Users can periodically wipe the table and panel of the analyzer with water or 75% ethanol.
If hazardous materials are leaking on the surface of the equipment or entering the interior of
the equipment, 75% ethanol should be used for disinfection. If you have questions about the
compatibility of disinfectant or cleaning agent with the equipment components or materials
contained in the equipment, you should consult the manufacturer or agent.

1.5 Exoneration clause

Tisenc is exempt from liability under the following circumstances:
1) Equipment damage caused by force majeure, such as earthquake.
2) Equipment damage due to user’s incorrect operation.
3) Losses due to the use or non-use of equipment, such as decreased turnover, inspection
interruption, effect to patients.
4) Damage caused by non-compliance with safety instructions in operating manuals.
5) Damage caused by connecting external computers/devices or software unrelated to
Tisenc.
6) Damage caused by accepting repairs by unauthorized personnel.

Instruction for User Chapter 2 INTRODUCTION OF SYSTEM
Chapter 2 INTRODUCTION OF SYSTEM

This Chapter include the introduction of system and packing of system.
2-1 Checking before using
The instrument has an excellent quality assurance system. It has been strictly inspected before
leaving the factory, and has been packaged for anti-collision and anti-vibration. However, it cannot
be ruled out that the product is strongly collided or squeezed during transportation, resulting in
damage to the product. Please check the following after receiving the analyzer
1> Check if there is any damage in the packing and the shell of the analyzer
2> Check the module of Analyzer
3> Check the packing list
2-2 Packing List
Below there is the packing list of system. Please check carefully before using.
SN Content Units Quantity Note
1 ACCRE-8 analyzer Unit 1
2 Reagent Rack Rack 1
3 Waste Tip Box Box 1
4 Thermo-Printer Paper Roll 1
5 Power Cable / 1
6 User’s Instruction Book 1
7 Warranty Card Sheet 1
Installation Receipt
8 Sheet 1
(3 parts)
9 Quick SOP Sheet 1
10 Quality Certification Sheet 1
Contents:
Analyzer

Fig 2-1 the ACCRE analyzer

Reagent Rack
Fig 2-2 the Reagent Rack

Waste Tip Box
Fig 2-3 the waste tip box

Printer Paper

Fig 2-4 the printer paper

Power Cable
Fig 2-5 the Power Cable

The ACCRE8 automatic CLIA analyzer supports an external barcode scanner. If necessary,
please contact Tisenc or an authorized representative to pay for the service. The external barcode
scanner can achieve the following functions:
Get the barcode of sample ID and user ID.
Input information about calibrators and controls by scanning a barcode.
Replace the touch input of touch displays in some situations.
2-3 System Features

1> Smart Size: 30% of regular CLIA analyzer, small and exquisite size, save space.
2> Automation: Fully automatic for test procedure
3> Batch mode: Maximum 6 assays can be perform at the same time in one Batch
4> Sample Type: Serum, Plasma
5> Short Assay time: Minimum 10 minutes assay time (assay time is different in each different
parameters)
6> Simple Use: Integrated single package reagent cartridge, ready to use, no any extra
consumable needed
7> Excellent Accuracy, Precision, Repeatability: High sensitive PMT for signal detection
8> Zero cross-contamination: single package for reagent, one independent cartridge for each
test, eliminate the cross-contamination.
9> Barcode Control: Test items, manufacturer calibration data, product expiration date are
stated on the barcode.
2-4 System Specifications:

Table 2-2 ACCRE System Specification

ACCRE System Specification
Serial
Parameters Description Note
Number
1 Analyzer Type Bench top /
Throughput may be
2 Through put 6 sample/ batch different for different
assays
3 Sample Type Serum, Plasma, Whole blood /
Incubator: 42℃
4 Temperature /
Reaction Chamber: 40℃
Detecting
5 300-650nm /
Wave length
Sample: Maximum 200000 Too many stored
results .No limitation of time results may cause the
QC: Storage and search the QC query to slow down.
6 Data Storage
result It is recommended to
Calibration: Maximum 5 lot periodically clear the
5 calibration each lot test data.
7 Service Life 10 years /
2-5 System Performance

2-5-1: Accuracy of temperature control is not applicable
The temperature accuracy is within ±0.5 °C of the set value, and the fluctuation does not
exceed 1.0 °C.
2-5-2: Stability of Analyzer
The Relative bias of test result for the analyzer at 0 hour, 4hours and 8hours after started are
less than 10%
2-5-3 With-in Run CV%
The with-in run CV% of the analyzer is ≤ 8%
2-5-4 Linearity
The linear correlation coefficient (r) ≥ 0.99 in the concentration range of not less than 2
orders of magnitude.
2-5-5 Main function
Users can use the man-machine dialogue command to enable instrument to automatically
complete analysis tasks of different samples and test items.
The instrument can indicate status of consumables and wastes such as reagents.
The instrument has a self-test function.
Fault prompt: The instrument has corresponding prompts for operation errors, mechanical
and circuit faults.
2-6 EMC
EMC standards
ACCRE 8 system has been tested and found to be in conformity with EN 61326-1:2013
Users should be responsible for ensuring that equipment is in a suitable electromagnetic
compatibility environment so that equipment can work properly.
It is recommended to evaluate electromagnetic environment before the equipment is used.

2-7 System Overview

2-7-1 System components
1> Control Module
2> Detection Module
3> Mechanical Module
4> Input Module
5> Output Module
6> Operator Software
7> Consumables
8> Power
2-7-2 Front View of Analyzer

The Front View of the analyzer are shown as Fig2-6
Fig 2-6 Front view of analyzer
Introduction:
1> Touch liquid crystals screen: monitor screen for software, and touch screen for software
operation.

NOTE: Do not touch the analyzer screen with sharp object or the pen point
2> Power switch: Turn on-off the analyzer

3> Chamber Door: Door of the reagent chamber, open the door to place the reagent rack and
tips into the analyzer. Please note that the door can’t be opened during the test procedure
4> Cover of Printer: Open the cover of printer to change printing paper, as shown in Fig 2-7
Fig 2-7 Change the printing paper

Please Note that thermo printing paper roll with the width 58mm, diameter <60mm
can be used on ACCRE-6 analyzer. Be careful of paper cutting when changing the printing
paper.
Be aware not to damage the door when opening.
5> Signal light:

The status of the current instrument is displayed as follows:
Green signal: The current instrument is operating normally.
Red signal: The instrument is currently in mechanical failure.
Blue signal: The instrument is currently being updated.
When the signal light is red because there is mechanical failure of instrument, please
contact authorized representative or technical service of Tisenc.
6> Printer: Print out test result
2-7-3 Back View of Analyzer

The back View of the analyzer are shown as Fig2-8

Fig 2-8 Back view of analyzer

Introduction:
1> Heat dissipation hole: It is used for internal air circulation when the fan is working.
2> Nameplate: nameplate of the analyzer display the analyzer’s information
3> Internet port: Port for internet connection.
4> USB port: Port for USB connection
5> Power switch: power on or off
6> Power Connector: Connector for power cable
Please note that: do not block the Heat dissipation hole when using the
analyzer
2-7-3 Inside View of Analyzer

The inside view of the analyzer is shown as Fig2-9

Fig 2-9 Inside view of the analyzer

Introduction:
1> Incubation: Incubate the reagent cartridge at 42℃ during the test.
2> Waste box: Discard the disposable tips after test.
3> Work station: Place the tips, reagent rack and waste box during the test.
4> Disposable tips rack: Place the disposable tips for the test.
5> Pipette (Inner structure, invisible from outside): 6 pipettes for pipetting of sample and
reagent.
6> Blade (Inner structure, invisible from outside): Blade to cut open the aluminum film of
the reagent cartridge during the testing procedure.
7> Magnetic parts(Inner structure, invisible from outside): Magnetic part for the separation
and washing procedure.
8> Heating zone(Inner structure, invisible from outside): Heat the tips and work station to
40 degree during the test.
Reagent rack must be place into the analyze during the test as shown in Fig 2-10

Fig 2-10 Place the reagent rack into analyzer

1> Reading Cup: Cups integrated in the reagent cartridge to read the light signal in the
final step of the test.
2> Reagent Rack: Rack with 6 channels to place the reagent cartridges for the test.
3> Reagent Cartridge: Tisenc reagent cartridge is for chemiluminescence
immunoassay. The cartridge can be used in ACCRE-6 analyzer only. Reagent strips are
specially designed with 19 wells, all required reagents have been sealed in specific wells in
aluminum film, and the aluminum film is printed with barcode and related reagent
information.
Load reagent strips and operate reagent rack: ensure that reagent strips are gently pushed
into the channels of reagent strips. Don’t irritate the foam in the reagent. The reagent rack has a
row of locking grooves near the user. A push to expected location will give a “click” indicating that
the reagent strip is in place.
2-8 System Consumables
Consumables needed for the test are listed as below:
Serial Number Name Quantity Specifications Note
1 Assay tips 1 tip/test custom made by Tisenc
2 Printing paper 5cm/test 58*60 mm
Assay tips are used for pipetting sample and reagent on the analyzer during the test procedure.
Tips are disposable, for 1 time use only. Each test needs 1 tip, and tips are custom made by Tisenc
and are provided to user with the reagent kit. Please contact with Tisenc’s authorized

representative and technical service if there is any problem in using the tips.
Fig 2-11: Assay tips

2-8-2 Printing paper
Thermo printing paper is place in the printer of ACCRE6 system to print out the test result.
Thermo printing paper with the width 58mm and diameter less than 60mm can be place into
ACCRE6 analyzer. A roll of printing paper is provided with an analyzer for free by Tisenc. And please
Contact with Tisenc’s authorized representative and technical service if extra printing paper need
to be purchased.
Fig 2-12: Printing Paper

2-9 Reagent Introduction
2-9-1 Reagent Cartridge
The reagent cartridge should work with ACCRE series analyzer only. Reagent cartridge is
integrated design, all components needed for the test are included in the cartridge already, and
each cartridge is for 1 test.
Fig 2-13 Reagent Cartridge

Each reagent cartridge contains different reagent components needed for the test inside. Each
component is contained in one well of the cartridge, and no other reagent component is needed
for the test. All the reagent well is sealed with aluminum film. The assay name, reagent expiry date,
reagent lot number, and a reagent bar code containing all the assay information are printed on the
aluminum film of the cartridge. There is a sample well on the right side of cartridge, and sample
for the test is pipetted into the sample well. A reading cup is placed on the left side of the cartridge,
and the PMT reads the light signal from the reading cup during the test.
Information on the reagent cartridge:
1> Lot Number: reagent lot number

2> Expiry Date: Expiry date of reagent. Please do not use the expired reagent. The analyzer
will scan the reagent information and notice the expired reagent.
Please Do Not Use the Expired Reagent for Sample Testing.

3> Applicable model: Applicable analyzer module for this reagent cartridge
4> Assay mode: Assay mode is indicated as Roman numeral Please note that only assays with
the same assay mode can be run together at the same batch.
5> Reagent Bar Code: Bar Code for reagent assay information. Reagent bar code can be
automatically scan by the analyzer during the testing procedure.
6> Temperature: Temperature for storage of the reagent cartridge.
2-9-2 Reagent Box

The reagent box contains reagent strips, instructions, registration card, calibrators and
calibration card. The reagent box as shown in Fig 2-14.
Fig 2-14 Reagent Box
1) Reagent Box: the reagent box contains reagent strips, instructions, registration card,
calibration products and calibration card.
2) Reagent strip: See figure 2-13 for reagent strip descriptions.
3) Instructions: explaining the information of reagent.
4) Registration card: the registration card is provided with reagent box. It contains the
information of master curve and calibration. Assay registration with registration card is
in needed for each time a new assay or a new lot of assay run on the analyzer. Please
refer to 5.2 for specific operation. You may use the registration card in the subsequent
process, and please keep it properly.

5) Calibration card: a barcode containing information about concentration of calibrators

CAL1~CAL3.
6) Calibrator: Calibrators are used for calibration to generate the working curve of assay
based on the master curve. Calibration is required while a new assay or a new lot of assay
is used. Please read the package insert carefully for the using of calibrator.
NOTE: The reagent packing of ACCRE system may differ. Please refer to the
physical object and call authorized representative or technical service of Tisenc if there
is any question.

Instruction for User Chapter 3 PRINCIPLE
Chapter 3 PRINCIPLE
3-1 Assay principle: CLEIA (Enzyme catalytic chemiluminescence immunoassay)
Luminescent assays are a common way to monitor an enzymatic reaction, where an enzyme
converts a substrate to a reaction product that emits photons of light instead of developing a visible
color. Luminescence is described as the emission of light from a substance as it returns from an
electronically excited state to ground state. When the excited intermediates return back to their
stable ground state, a photon is released, which then can be detected by the luminescent signal
instrument or observed by human eyes. Chemiluminescence is light characterized by a chemical
reaction. The chemiluminescent substance is excited by the oxidation and catalysis forming
intermediates. Chemiluminescence is powerful detection techniques superior to other detection
principles involving light, such as fluorometry, due to special features including low noise levels,
large detection range, and quick response.
Fig 3-1 Dynamic curve of CLIA

Instruction for User Chapter 3 PRINCIPLE
3-2 Assay Procedure

3-2-1 1-step assay procedure
3-3 Introduction of PMT signal reading

The light signal generate by the chemiluminescent reaction is detected by a high sensitive and
low noise Photon multiplier tube (PMT). Detection rage of PMT is between 300nm-650nm, PMT
detect the light signal at 420nm in ACCRE-6 system. Photomultipliers tube acquire light through a
glass or quartz window that covers a photosensitive surface, called a photocathode, which then
releases electrons that are multiplied by electrodes known as metal channel dynodes. At the end
of the dynode chain is an anode or collection electrode. Over a very large range, the current flowing
from the anode to ground is directly proportional to the photoelectron flux generated by the
photocathode. The light signal then transfer into Relative Light Unit (RLU) as a digital number of
light signal.

Instruction for User Chapter 4 SOFTWARE OPREATION
Chapter 4 SOFTWARE OPREATION

4-1 Work with Touch Screen
The ACCRE-8 operation software work with 15.6-inch colorful touch screen.
4-2 Start the analyzer
Connect the power cable of the ACCRE-6 analyzer to well- grounded electronic source.
Turn on the analyzer, the software will turn on and start with Log-in Menu, as shown in Fig 4-
1
Fig 4-1 Log In Menu

4-3 Software operation
4-3-1 initial user’s account and password
The initial user’s account name is: user
The initial user’s password is: 123456
(1) When the user starts the instrument system for the first time, the system gives the
default login only by inputting the above initialization user name and initial password.
(2)Click the password column and type in password in the soft keyboard, as shown in Fig 4-2
Initialize the user account and password, and do not provide support for users to
modify, delete, etc.
Keyboard:

Instruction for User Chapter 4 SOFTWARE OPREATION
Contains type buttons (letters, numbers, symbols, action buttons).

The operation buttons are as follows:
Enter
Caps Lock
Space
Delete
Symbol
3）Click “Log In” icon to start the software if the user name and password is confirmed correct.
The software will start, the ACCRE-6 system start initialization.
System initialization include the below procedure:
⚫ Assay file checking
⚫ Initialize the power of PMT ( photomultiplier tube)
⚫ Initialize the syringe module
⚫ Initialize the PMT module(photomultiplier tube)
⚫ Initialize the Magnetic module
⚫ Initialize the Incubation module
⚫ Initialize the piston module
⚫ Printer paper checking
If any errors happen during the initialization procedure, software will show error message,
please check Chapter 9 for the detail error message and resolutions.
4-4 Software Main Menu
Analyzer will enter the main menu of software.
There are 6 Main Menu in ACCRE-8’s operation software:
1> TEST: for sample, calibration and QC test.
Please check Chapter 8 for the detailed introduction of test.
2> Calibration: for calibration, Please check Chapter 6 for the detailed introduction of calibration.
3> Control: for ensure the reliability of test results. Please check Chapter 7 for the detailed
introduction of control.
4> SEARCH: For searching the sample test, calibration and QC result.
5> SYSTEM: For the setting of system.
Please check Chapter 5 for the detailed introduction of each menu.
6> Close: for stop or restart the analyzer

Instruction for User Chapter 5 SOFTWARE-SETTING MENU
Chapter 5 SOFTWARE-SETTING MENU

Registration and System setting are recommended after first installation of the ACCRE 8
analyzer.
5-1 Summary of SETTING Menu
Enter the main menu of the software, and then go to SETTING menu.
The SETTING menu includes the following sub-menu:
Calibration Setting: For the setting of calibration
ASSAY Setting: For the setting of assay testing
QC Setting: For the definition of Quality Controls
General Setting: For the setting of account management, LIS, language and date and time,
etc.
5-2 Calibration Setting

Click “Calibration Setting” and the interface is shown as Fig 5-1.
Fig 5-1 Calibration Setting

Information about registration
a) Click the inputting box for inputting registration information. Scan project
registration cards in large kits with the scanner.
b) Click “OK”, get information below:
Reagent: name of reagent assay
Lot: lot of reagent assay
CAL1\CAL2\CAL3\RLU\Concentration: assay master curve information can be loaded into the
analyzer during registration procedure.
Registered reagent information inquiry
1) Click the [Reagent] drop-down box to select the reagent item that has been registered for
the setting.
2) Click the [Lot No.] drop-down box to select the reagent lot number to be set for the selected
item.
After selecting the reagent and lot number, the instrument will automatically display the
corresponding registration information of reagent item.
Data import (reservation function)
Data export (reservation function)

Save
Scan the project registration QR code to obtain registration information, click [Save] to save
the registration information of the current reagent.
Delete
1) Query and display the required registered project batch information.
2) Click [Delete] to delete the batch registration information of the project.
When assay registration is finished successfully, other procedure can be process.

NOTE: IF THERE IS A INTERREUPTION OF POWER SUPPLY DURING
REGISTRATION PROCEDURE, THEN REGISTARTION WILL FAIL. PLEASE REPEAT THE
REGISTRATION PROCEDURE AFTER RESTART THE ANALYZER.
5-3 QC Setting
Definition of Quality Control can be process on “QC” Menu.
Click ”SETTING”-> “QC”, the “QC” menu is shown as Fig 5-2
Fig 5-2 QC Setting Menu

1> Assay: select the assay for QC definition in the drop-down menu of “Assay” Column first,
please note the only successfully register assay can be found in this menu.
2> QC Name: Enter the name of QC in this column, QC name can be loaded by typing in the
soft keyboard or by scanning bar code using external bar code scanner. Numbers and characters
are support as QC name.
3> QC Lot: Enter the lot number of QC, QC lot can be loaded by typing in the soft keyboarder
by scanning bar code using external bar code scanner. Only numbers are support as QC lot number.
4> Level: Select the level of QC here, there are 3 options in ACCRE-8 software: H: High, M:
Middle, L: low.
5> Target Value: Enter the target value of selected level of QC here.
6> Rules of QC: The quality control rule is the decision criterion for making quality control
state judgment. If the value obtained by the quality control test is within the selected quality
control rule, the quality control state is judged to be in control; if the value of the quality control
test exceeds the quality control quality control rule, the quality control state is judged to be out of
control. This item supports multiple selections, but the system defaults to the same type of quality
control rules can only check one.
When the quality control status is judged to be out of control, please recalibrate. If the problem still
cannot be solved, please contact the agent, and the agent will contact the manufacturer to help you.

Add
After the quality control setting fill information is completed, click [Add], the
information of the quality control setting will be displayed in the QC setting
information column. If the quality control name, quality control batch number, and
reagent name quality control level selected by the user are consistent with those
stored in the quality control setting information column, the original desired target
value and expected SD are covered.
Delete
Select the information bar in the QC settings information bar and click [Delete] to
select the message bar to clear.
The reservation function is reserved for use after the next upgrade.
5-4 Assay Setting

Click ”SETTING”-> “Assay Setting”, the “Assay Setting” menu is shown as Fig 5-3
Fig. 5-3 Assay Setting

Reagent name
Click the Reagent Name drop-down box to select the item you want to set. The drop-down
box will display the name of the reagent item that has been registered in the instrument.
Concentration unit
The user can convert to the required unit by unit conversion, such as input
ng/ml*1.54=nmol/L or ng/ml*1=ng/ml; if the unit is not set, the instrument will automatically use
the default unit as ng/ml.
Detecting linear range
Set a value for the lower limit of the detected concentration range of the selected indicator. If
the actual detection result is lower than the setting lower limit value, the test result will display by
default lower than the lower limit value setting by the indictor. If this item is not set, the instrument
displays the value obtained by the actual test. Set a value for the upper limit of the selected
indicator. If the actual test result is higher than the setting upper limit value, the test result will
display by default upper than the upper limit value.

Normal range
The test report provided by the ACCRE8 automatic chemiluminescence analyzer can show that
the test value is high, low, and normal. This function requires the user to set the normal value range
to take effect.
Sample test default settings
Contains the sample type and dilution. The corresponding sample type (visible) and dilution
(not visible) of the setting is automatically loaded by the software when the user skips the loading
step during the test.
Concentration decimal digit display setting
To set the limit for the decimal point of the concentration input, set it as required in Figure 5-
4.
Fig. 5-4 Concentration decimal digit display setting

The reservation function is reserved for use after the next upgrade.
Delete selected test setup data

Click to select a setting information bar in the test setting information bar, and click [Delete
Selected] to delete the selected information bar; if multiple messages are selected at the same
time, the system will delete from bottom to top by default.
Save test setup data
Fill in the required fields of the test settings and click [Save] to save the current settings
information to the test settings information bar.
5-5 General Setting

Click ”SETTING”-> “General Setting”, the “General Setting” menu is shown as Fig 5-4

Fig 5-4 General Setting

User Management
The module contains four functions: add new users, switch users, modify user passwords,
delete users, and new users are visible in the user information bar. As shown in Figure 5-5.
Fig 5-5 User Management

Add new users
In the User ID and Password, Confirm (New) Password input box in Figure 5-5, enter the new
user ID, password, confirmation password, click [Add New User ID], and add the user ID successfully,
then the registered user is displayed in the account column.
“user” is the default account, and new account name should be avoided.
In the user ID and password input box in Figure 5-5, enter the ID and password of the switching
user, and click [Switch User ID], a dialog box will pop up to prompt the user to switch successfully.
Modify user password

In the user ID and password and new password input box in Figure 5-5, enter the modified
user name, password, and new password. Click [Modify User Password]. If the password is
successfully modified, a prompt to change the password is displayed.
The modified user must be existing, and the new password entered cannot be the same
as the original password.
Delete users
In the input box, enter the user name and password, click [Delete User ID], and the deletion
is successful, then the registered account column clears the information of the entered user.
LIS settings
The LIS settings include the following, as shown in Figure 5-6.
Fig 5-6 LIS Setting

For the above settings, please contact the network administrator to obtain the corresponding
information input, and click [OK] to automatically connect the LIS server.
If the connection is not successful, check whether the network cable and the serial cable
are properly connected.
Time
Click the time item display box of the software interface to slide the selected part
(year/month/day/upper afternoon/hour/minute), and click or button to modify the

selected time or date. The time setting is shown in Figure 5-7.
Fig 5-7 Time and Language Setting
Language
Click the drop-down box to select the language in English/Chinese. Select English, click [Save
Current Settings], then the instrument software operation interface will be converted to English
version after the instrument is restarted. Select Chinese and click [Save Current Settings]. After the
instrument is restarted, the current instrument software operation interface will be converted to
the Chinese version. The language setting is shown in Figure 5-7.

Instruction for User Chapter 6 Software- CALIBRATION
Chapter 6 Software- CALIBRATION

6-1 CALIBRATION
6-1-1 Purpose of calibration
Calibration of reagent kit need to be performed in the analyzer to generate the valid Working
Curve of reagent kit from its original Master Curve, and to guarantee the accurate test result. The
Master Curve of each lot of reagent is loaded to the analyzer through registration procedure (See
Chapter 5.2), Working Curve is generated through a 3-point calibration base on the loaded master
curve. Calibration need to be performed before running Control and Sample test.
6-1-2 Calibration
Calibration is needed when:
1> New assay is introduced into the analyzer
2> New lot of reagent is introduced into the analyzer
3> Calibration expired, the valid time of calibration differ among different assays, please Check
the pack insert of reagent carefully before perform the calibration.
4> Quality Control out of range
5> After the maintenance of the PMT and signal reading system of analyzer.
6> Other situation when needed
6-1-3 Preparation of the calibration
Turn on the analyzer, Select [CALIBRATION] Menu, as show in Fig 6-1.
The information of Calibrator Lot, Calibrator concentration and detail information of Sample
Channels can be founded in the screen.
Fig 4-1 calibration test Menu
6-1-4 Check the Validity of Calibrator

Please check the lot number, expiry date of calibrator before perform calibration, information
about the lot number and expiry date of calibrator can be founded in the package insert.
6-1-5 Check the Validity of Calibrator
2> Load Calibrator information
There are 6 channels display in the software, each channel correspond to each position in
reagent rack. When loading calibrator information, select “Channel 1” in the software, click
“Calibrator Lot” column to type in the calibrator lot number, then click “Calibrator Conc.” column
to type in the calibrator concentration. Detail information about the calibrator lot number and
concentration can be founded in the package insert. Then click “Load” icon in the software to load
the calibrator information into that channel.

After Channel 1 is successfully loaded, move the next channel and repeat the above procedure
to load calibrator information into other channels.
Please check the calibrator information in each channel carefully after loading, If the loading
of the information is in-correct, the information can be correct by select that specific channel and
re-type in the calibrator lot and concentration, and load the information again.
NOTE: PLEASE NOTE THAT WHEN PERFORM CALIBRATION IN ACCRE-8 ANALYZER,
CALIBRATOR 1 SHOULD BE LOAD INTO CHANNEL 1 AND 2, CALIBRATOR 2 SHOULD BE LOADED IN
CHANNEL 3 AND 4, CALIBRATOR 3 SHOULD BE LOADED IN CHANNEL 5 AND 6
6-1-5 Channel error message coverage

Select, input the correct information into the input box of the corresponding channel
information bar, and reload.
6-1-6 Clean the information of ALL CHANNELS
[Clean]
Select the channel corresponding to the data to be deleted, and click [Empty] to pop up the
confirmation window.
[YES]
Click [OK] to clear the information in the selected channel.
[NO]
Click [NO] to cancel the current operation.
[ALL]
Click [ALL] to clear all channel information.
6-1-7 Confirmation information
After the required calibration test information is loaded, view the display information on the
calibration test interface. If it is wrong, please reload.
6-1-8 Place the waste box of tips
Please check if the waste box of tips in the analyzer in empty, before start the calibration, if
not, please empty the waste box, then place the empty waste box into the analyzer.
NOTE：IT IS RECOMMANDED TO CLEAN THE WASTE BOX EVERY 20 TESTS OR EVERY WEEKS
6-1-9 Preparation and loading of reagent cartridge

Please follow the below instructions carefully when process with the reagent cartridge
➢ Wear the gloves and mask to prevent contamination of sample and reagents.
➢ DO NOT splash liquid into the reading well of the reagent cartridge.
➢ Shake the reagent violently, it will affect the test result.
Insert the reagent cartridge into the reagent rack as shown in Fig 6-2
Fig 6-2 Insert the reagent cartridge into the reagent rack

Calibrator/Sample pipette: pipetting the certain amount of sample using micro pipette as
shown in Fig 6-3, calibrator of reagent is pipette as sample, please check the reagent package insert
for the detail information about the sample volume needed for each assay.
Avoiding bubble when pipetting sample, because bubble may affect the test result.
Fig 6-3 Pipette sample into the reagent cartridge
Open the door of the reagent chamber of the analyzer and place the loaded reagent rack
into the analyzer, as shown in Fig 6-4
Fig 6-4 Place the loaded reagent rack into the analyzer
Loading the disposable tips

Please Load the disposable tips provided by TISENC into tips rack of the analyzer, as shown in
Fig 6-5
Fig 6-5 Loading the disposable tips into the tip rack
Please load the tips carefully and that ensure that the pointed end of the tips should not touch
the tip rack when loading the tips, to avoid contamination of tips.
6-1-10 Check Thermo-Printer

Please check if there is any paper in the instrument before starting the test. If it is used up,
please replace it in time. If the instrument does not have paper, the test result will not be printed.
To replace the paper, see 10.3 replacing the paper.
6-2 Start the CALIBRATION

[START]
After finish the above procedure in 6-1, click icon in the CALIBRATION menu to start
calibration. The analyzer will start initialization procedure before the calibration procedure started.
The load concentration is directly obtained from the registration information in the
calibration settings in the following cases after startup.
➢ The calibrator concentration is not loaded.
➢ The calibrator information is not loaded enough.
[STOP]
If emergency stop of the analyzer is needed to be perform during test. Please click the
button, the analyzer will stop and after confirmed with click “YES” in the pop-out dialog box.
DO NOT stop the analyzer if it is not needed, once the analyzer is stop, the reagent and tips
on board should be discarded without the result. Assays on board should be re-run.
6-3 Result of Calibration

Result of calibration will display as “calibration success” or “calibration failed” in the scree.
Click “OK” to confirm the result. And calibration result can be printed by the thermo printer.

6-4 Discard the used reagent and tips

6-4-1 Discard the used tips
Discard the used tips in the waste box and clean the box after every run of test, please follow
the safety regulations of laboratory
Place the waste box back to the analyzer after discard the used tip.
6-4-2Discard the used reagent cartridge
Remove the used reagent cartridge from the reagent rack, and discard the reagent cartridge
as medical waste, please note that DO NOT splash the liquid in the reagent cartridge

Instruction for User Chapter 7 Software- QC
Chapter 7 Software- QC
7-1 QC Test
7-1-1 Purpose of QC
To insure the reliability of the test results, hereby to improve the stability of reagents
&analyzer.
7-1-2 Calibration
Quality Control (QC) should be performed according to the laboratory regulation, to
guarantee the analyzer and reagent are in good working condition. The QC result should be in the
QC range, if the QC result is out of range, re-run QC or re-calibrate the reagent.
Contact the Tisenc representative or service if the QC is still out after re-calibration.
There are Internal QC provided by Tisenc, please contact Tisenc or authorized representative
to purchase the internal QC from Tisenc.
1> QC level
There are 3 levels of QC: High, Middle and Low
2> When QC need to be perform
➢ After previous QC expire
➢ After every calibration of reagent
➢ After change the setting of assays
➢ When sample result is suspicious
➢ After maintenance of PMT or pipette system of the analyzer.
➢ When the Quality management system required
7-2 Preparation of QC test

When performing the QC test, assay, reagent lot number, and QC level should be define in the
QC menu of the software, please check Chapter 5.4 for the definition of QC.
7-2-1 QC Test Menu

Enter QC menu, as below Fig. 7.1
Fig 7-1 QC Menu

7-2-2 Check the validity of QC
Please check the lot number, expiry date of QC before perform QC test, information about the
lot number, expiry date and target value of Tisenc internal QC can be founded in the package insert
of reagent.

7-2-3 Input the QC Test

Before starting the QC Test, it is necessary to input the QC info as fig. 7-2.
Including QC name, Target value, Lot Number, QC level.
Fig 7-2 QC in data

【Assay】
Select ”Assay”. The parameter should be registered and calibrated
【Name】
Select “Name”, the relevant QC info will be shown if the data was input, if the data was not
input, this menu will show nothing
【QC lot】
Select ”QC lot” , select the relevant QC Lot number.
【Target】
Select “target”, the corresponding Target value will be shown as setting in 5.4 QC setting.
【Level】
QC level includes H(High), M(Middle), L(Low) levels, the user choose the level accordingly.
7-2-4 Loading Channels

【Loading】
1. Select one channel in QC1-QC6.
2. There are 6 channels display in the software, each channel corresponding to each position
in reagent rack.
3. Input all the QC info, and click “ Loading”
【after loading】
1. QC loading info is shown in the corresponding QC column.
2. In the QC curve, the curve of the latest 10 QC test will be shown.
7-2-5 Wrong information Coverage

Select the corresponding channel with the wrong info, the wrong info will be displayed, revise
the info, and reload.
7-2-6 Clear info
Clear
Select the corresponding channel, click” clear”, then a small window will display.
【YES】
Click” YES”, then the channel info will be cleared.
【NO】
Click “NO”. then the operation will be cancelled.
all
Click “ all”, then all the channels info will be cleared.
7-2-7 Confirm the QC information in all channels
Please double check and confirm all the QC information in all the 6 channels before start the QC
test. If there is error, please reload.
7-2-8 Place the waste box of tips

Please check if the waste box of tips in the analyzer in empty, before start the QC Test, if not, please
empty the waste box, then place the empty waste box into the analyzer.
IT IS RECOMMANDED TO CLEAN THE WASTE BOX EVERY 20 TESTS OR

EVERY WEEKS

7-2-9 Samples Preparation

Please refer to the Package Insert when preparing the samples for the different parameters.
7-2-10 Instructions for loading the reagents
When doing test with the reagent strip, the below instruction should be followed.
➢ Wear the gloves and mask to prevent contamination of sample and reagents.
➢ It is recommended to pre-warm the reagent at room temperature after take out from the
refrigerator.
➢ Follow the instruction of package reagent insert.
Insert the reagent cartridge gently and carefully into the reagent rack, make sure the
reagent cartridge is fixed tighten in the reagent rack
➢ Please not that holding the handle gently when inserting the reagent cartridge into the
reagent rack, Do NOT touch the aluminum foil film and the reading cup on the reagent
cartridge, this will affect the test result.
➢ DO NOT splash liquid into the reading well of the reagent cartridge.
➢ DO NOT turn over the reagent cartridge or shake the reagent violently, it will effect the test
result.
7-2-11 Insert the reagent strip

Insert the reagent strip into the reagent rack gently ,refer to Fig7-3
Fig 7-3, insert the Reagent Strip
The strips quantity of the QC test could be determined by the user, Maximally 6 strips
could be tested, and the strips could be inserted randomly.
Pipetting the certain amount of sample using micro pipette as shown in Fig 7-4, QC of reagent
is pipetted as sample, please check the reagent package insert for the detail information about the
sample volume needed for each assay. Avoiding bubble when pipetting sample, as bubble may
affect the test result.

Fig7-4, Sample pipetting.

Open the chamber cover, put the reagents rack accordingly as Fig7-5:
Fig7-5 Put the Reagents Rack into the chamber
When pipetting the samples, take use of the pipettor vertically to avoid the liquid
contamination with the pipettor head.
Please place the reagent rack in right order to ensure the rack in a dedicated
position.
7-2-12 Place the tips
Place the tips as the below picture in Fig 7-6

Fig7-6 place tips
Please load the tips carefully and that ensure that the pointed end of the tips should not
touch the tip rack when loading the tips, to avoid contamination of tips.
7-2-13 check the printing paper

Please check whether there is printing paper before testing, if there is no paper, the test result will
not be printed, please refer to 10.3 for the change of printing paper.
7.3 QC test .
Start
Click , when all the preparation is finished.

When starting the QC test, the analyzer will start initialization procedure before the QC test
procedure started
If there is any errors happened during initialization, an error message will be shown in the software
screen. Please check Chapter 11 for the resolution of errors.
Stop
During test, click , a dig box will pop up, if click “Yes”. The test will stop, if click “No”, the test
will continue.
7.4 Output the QC test result
When the test is finished, the test result will show in the software, meanwhile a diag-box will show,
click “OK”, then the built-in Thermo-printer will print out the QC test report.
7.5 Discard the used reagent and tips
7-2-14 Discard the used tips
Discard the used tips in the waste box and clean the box after every run of test, please follow the
safety regulations of laboratory Products. Place the waste box back to the analyzer after discard

the used tip.
7-2-15 Discard the used reagent cartridge

Remove the used reagent cartridge from the reagent rack, and discard the reagent cartridge as
medical waste, please note that DO NOT splash the liquid in the reagent cartridge. Also please
follow the local regulations.

Instruction for User Chapter 8 Software-Test Menu
Chapter 8 Software-Test Menu

8-1 Sample test
8-1-1 Preparation of sample test
The setting on the ［TEST］ is needed before start sample testing, please see the Charter
5.5. After successful test setting, then move to the next operations.
8-1-2 Sample test Menu
Fig 8-1Sample testing Interface（sample type）
8-1-3 Check the Validity of Reagent

Please check the assay name, reagent lot number, reagent expiry date before perform sample
test, information about the reagent lot number and expiry date can be founded in the package
insert.
The instruction of reagent boxes plese see the Chapter 2.9.3 “ Reagent box”
8-1-4 Enter sample ID

Patients information should including as below Fig 8-2：
Fig 8-2 Patients Information

Entering Sample ID is required before start the sample test, there are 3 ways to enter the
sample ID in the software.
➢ By Bar-code scan: Click the “Sample ID” column in the software, and scan the sample ID
in the sample tube by external hand carry bar-code scanner, the bar-code can be
recognizing and loaded into the analyzer as shown in Fig 8-3
IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd - 48 -

Fig 8-3 Scan the sample ID by barcode scanner

➢ By type-in: Sample ID can be entering by type-in using the soft keyboard in the software.
Click the “Sample ID” column, the soft keyboard will pop-out in a dialog box as shown in
Fig 8-3. Sample ID can be typed using the soft keyboard. Numbers and Character are
support as sample ID.
➢ By Automatic generation: in ACCRE6 system, sample ID can be generating automatically
by directly click “Load” icon after select channel in the “SAMPLE” menu. The Auto-
generated sample ID will be display as the combination of date (YYYYMMDD) + serial
number, like 20180101001
Confirm sample type
Click “Type” column in “SAMPLE” menu to select proper sample type for the test, there are 2
types of sample “serum” and “plasma”.
Confirm dilution
Click “Dilution” column in “SAMPLE” menu to select proper dilution for the test, there are 6
types of dilution as option.
8-1-5 Load sample information

【Load】
1）There are 6 channels display in the software, each channel corresponds to each position

in the reagent rack.

2）When loading sample information, select “Channel 1” in the software, click “Sample
ID” column to enter correct Sample ID. Then click “Load” icon in the software to load the
sample into that channel.
3）After Channel 1 is successfully loaded, move the next channel and repeat the above
procedure to load sample information into other channels. Maximum 6 different reagents can run
in one batch.
The previous records will be replaced if the sample information load at the
selected channel
8-1-6 The wrong loading information correct
Please check the sample information in each channel carefully after loading, if the loading of
the information is incorrect, the information can be correct by select that specific channel and re-
type in, and load the information again.
8-1-7 Clean the information in channels

【Clear】
Please long press the selected Channel, then click “OK” in the pop-out dialog box.
【YES】
Click【YES】, it means selected channel will be clean
【NO】
Click【NO】,it means stop
【All】
Click【All】, It means all information in Channels will be clean
8-1-8 Place the Waste box of tips

Please check if the waste box of tips in the analyzer in empty, before start the calibration, if
not, please empty the waste box, then place the empty waste box into the analyzer.
IT IS RECOMMANDED TO CLEAN THE WASTE BOX EVERY 20 TESTS OR EVERY
8-1-9 Preparation of samples

Please read the package insert carefully before start to pipette the sample into the reagent
cartridge, notice the different sample volume, and sample types for different assay.
WEEKS
8-1-10 Preparation and loading of reagent cartridge
Please follow the below instructions carefully when process with the reagent cartridge：
1）DO NOT leave the reagent cartridge exposed to the lights for a long time, maximum 5
minutes under lights
2） Wear the gloves and mask to prevent contamination of sample and reagents
3） It is recommended to pre-warm the reagent at room temperature after take out from the
refrigerator.
4）Please follow the instruction on the package insert
a) Please not that holding the handle gently when inserting the reagent cartridge into the
reagent rack, Do NOT touch the aluminum foil film and the reading cup on the reagent cartridge,
this will effect the test result.
b) DO NOT splash liquid into the reading well of the reagent cartridge
c) DO NOT turn over the reagent cartridge or shake the reagent violently, it will effect the test
result.
8-1-11 Reagent cartridge insert

Insert the reagent cartridge into the reagent rack as shown in Fig 8-6
Fig 8-6 Reagent cartridge insert

Pipetting the certain amount of sample using micro pipette as shown in Fig 8-7, calibrator of
reagent is pipette as sample, please check the reagent package insert for the detail information
about the sample volume needed for each assay. Avoiding bubble when pipetting sample, cause
bubble may effect the test result.
Fig 8-7 Pipette samples

Open the door of the reagent chamber of the analyzer and place the loaded reagent rack into
the analyzer, as shown in Fig 8-8

Fig 8-8 Load reagent rack
When pipetting the sample, be careful to use the pipette vertically so that the
sample liquid does not touch the head of the pipette and cause contamination
When loading the reagent rack, do not put the reagent rack in reverse and
ensure that the reagent rack is placed in a certain groove in a flat way.
Please load the tips in tips rack, as below Fig 8-9：
Fig 8-9 Load the tips
Please load the tips carefully and that ensure that the pointed end of the tips
should not touch the tip rack when loading the tips, to avoid contamination of tips.
8-1-13 Check on the printing paper

Before starting the test, please check whether there is any printing paper in the instrument.
For replacement of printing paper, see Chapter 10.3 for replacement of printing paper.
8-2 Sample test

【START】
After pre-works in sample test，Click button

After starting the sample test, the instrument will be initialized and reset.
Do not leave after the test starts. If any abnormality is detected during instrument
initialization inspection, the software interface will display relative abnormality information. If
there is an exception, please handle and take corresponding measures according to the abnormal
information displayed. For detailed exception information processing, please refer to chapter 11
of this manual
【STOP】
In process of sample testing，click then if click 【Yes】in the pop-out dialog box,
the test will stop and analyzer revert, if click 【No】, the test will ongoing.
8-3 Print out sample test results
After the test, the test information bar will display the sample test results.
At the same time, the thermal printer of the instrument will print out the test result report of
the sample.
8-4 Dispose used reagents cartridge and used tips
8-4-1 Dispose used tips
Please take out the used tips from the waste box, and then waste should be follow the local
rules of waste treatment. Please do not forget to reset the waste box.
8-4-2 Dispose used reagent cartridge
Please take away the reagent rack from the analyzer, then take out the used reagent
cartridge from the reagent rack. Do not make the reagent drip or spatter when the reagent
cartridge move.

Instruction for User Chapter 9 SOFTWARE- SERACH MENU
Chapter 9 SOFTWARE- SERACH MENU

9-1 SEARCH
Enter the main menu of the software, go to SEARCH menu, the menu is shown as below:
Fig 9-1 SEARCH menu in main software screen
9-2 Search the CALIBRATION result

Enter the calibration interface as shown in Fig 9-1. The operation steps of Search the
Calibration are as follows:
Reagent
Selected reagent name, the items shown in the reagent column have been tested for
calibration.
Reagent Lot
After selected the reagent name, in the reagent lot column, select the reagent lot of the
required query for the reagent item.
As follows:
▶ Calibration curve query information table
▶ calibration curve
▶Main curve RLU and corresponding concentration value information table
After the query has obtained the calibration result record, can do the following:
Correct calibration data
In the edit box, double-click the input box, use the software keyboard to modify the values of
RUL1 and RLU2 in CAL1, CAL2, and CAL3. After completing the input, click [Correction], and add a
calibration test record according to the modified calibration data.
The values of the input RLU1 and RLU2 must be close to the main curve calibration point
Chemiluminescence value and the corresponding concentration value.
Print calibration curve
Calibration result can be printed by click the “print” icon.
Delete calibration curve
Calibration result can be delete by click the “delete” icon.

9-3 Search the Sample Test Result

Sample test result of the reagents as shown in Fig 9-2
Fig 9-1 Test result menu in main software screen

【search】
Users can query by entering the following information:
1） reagent（reagent name）
2） Sample number
3） User
4） Name
【Assay time】
Select start time and end time, click .
Time is selected by and .

click 【search】
【Sample detection curve】
Click [Sample Detection Curve] to switch to the sample detection curve, as shown in Fig 9-
3:

Fig 9-5 QC menu in main software screen

The test query graph shows nearly 30 sample test information data within the selected query
range.
【Print】
Selected test information in the [sample test information table], click [Print], and print the
selected sample test information.
9-4 Search the QC result
Enter the main menu of the software, go to QC menu, the menu is shown as below
Fig 9-4 QC menu in main software screen

The steps are as follows:
1） selected 【reagent name】, quality control line chart of the reagent item for nearly 30
times will be displayed.
2） Select start time and end time, click .

Time is selected by and .
3） click 【search】
4） QC result can be printed by click the ‘print’ icon.
Repeat the above procedure by select assays and date to check different QC results
9-5 About
Click [About], the user can query the current program version of the display controller and

the current program version of the temperature controller as shown in Fig9-5:
Fig 7-6 interface of “about”

Instruction for User Chapter 11 Error Messages and Trouble shooting
Chapter 10 MAINTENANCE
10-1 Purpose of Maintenance
The purpose of maintenance for the analyzer is to guarantee that the analyzer can keep in
good conditions to operate. Please follow the instruction carefully for the maintenance procedure.
10-2 User’s Maintenance Procedure

10-2-1 Weekly Maintenance
1> Clean the Waste box of tips
Waste box of tip is recommend to be clean once every 20 tests or every weeks.
2> Clean the reagent rack
Clean the reagent rack with alcohol cotton several time
3> Clean the table
Clean the table with alcohol cotton several time
10-2-2 Monthly Maintenance
1> Clean the surface of analyzer gently by damp cloth.
a) DO NOT get any liquid or detergent into the analyzer during the clean procedure.
b) Please note that alcohol cannot be used because the door of reagent chamber is made
by acrylic, and alcohol can damage the acrylic door.
2> Clean the tip area
Clean the area where the tips are placed with alcohol cotton several time. Please change the
alcohol cotton for every tip position to reduce cross-contamination.
10-3 Replace the Paper of Thermo-Printer

Please check if the printer frequently, and if the printer paper is out, change the printer paper
according to the following procedure:
Open the thermal printer cover on the right side of the analyzer, Fig 10-1
Fig 10-1 Open the thermal printer cover

Remove the used printer paper reel, and install the new printer paper reel into the printer,
please note the direction of paper reel, as Fig 10-2, then place the setting plate of the printer into
its original position. Close the cover of printer and cut the extra paper roll outside.
Fig 10-2 Install the printer paper

10.3.1 Recommended periodical maintenance
It is recommended to do periodical maintenance for the analyzer to ensure the analyzer’s best
operation condition, please contact the authorized representative or technical service of Tisenc for
the detail information.

Chapter 11 Error Messages and Trouble shooting

Listed below are all of the error messages programmed into the ACCRE analyzer.
• If error messages other than the ones below appear, call Tisenc Technical Assistance or your local
representative.
• In some cases, there are suggestions for corrective action. Where no corrective action
impossible, or if the corrective actions fail, the final action is to call Tisenc Technical Assistance or
your local representative.

11-1 Table Error Messages and Resolution
Error Analyzer’s
SN Error category Error Description Resolution for Users
Level Respond
1 Fail to access the assay parameters
Fail to access the Internet connection
2
parameters
3 Fail to access the QC parameters
4 Documents Error Fail to access the Calibration parameters
5 Fail to access the QC data Error Message will
6 Fail to access the TEST data display in software
7 Fail to access the SYSTEM data screen, analyzer will Restart the analyzer by turn-
8 Fail to access the Users Account data pause on going test if off the power switch and
9 Motion Error Error code 0-1000 error happens, Use turn-on the power switch
Level
10 Initialization Error should read the error again. If the error occurs
1 Reading Error
11 Reading Error message and again please contact
12 Syringe initialization Error Click ”OK” to authorized representative or
13 Pipette initialization Error continue, analyzer will technical service of Tisenc
14 PMT vertical position initialization Error restart after click
15 PMT horizon position initialization Error “OK”
16 Other Errors Magnetic part initialization Error
17 Incubation initialization Error
18 Incubation Temperature Out of Range
19 Pipettor Temperature Out of Range
22 Fail to Save Data

Check if the barcode is

23 Fail to recognize Barcode
complete
Check if the barcode is
24 Abnormal Barcode
provided by Tisenc
Level2 Not categorized Notice Check if the tip is correctly
25 Fail to detect tips
placed
Check the connection of
26 Internet Connection Failed cable, then check if all the
parameters is correctly set
Level Check according to the
27 Not categorized Instruction for the Users Notice
3 instruction
Note: Error level indicate the severity of errors ,Level 1 is the most sever error

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ACCRE8

Automatic Chemiluminescence Immunoassay (CLIA)

Shenzhen Tisenc Medical Devices Co., Ltd

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 1

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 2

2) The instrument is operated until it is used.

Warranty and repair services

After-sales service department

Shenzhen Tisenc Medical Devices Co., Ltd.

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 3

Shanghai International Holding Corp. GmbH (Europe)

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 4

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 5

5-3 QC Setting ...................................................................................................................... 31

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 6

Chapter 1 SAFTY NOTE

Electric shock warning

Danger of Acid Liquids

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 7

1-2 General Symbols

Authorized Representative in the

Shelf life ,Use by Date

Lot Number, Batch code of each lot of

Consult Instructions for Users

Caution, consult accompanying documents

For In-Vitro Diagnostic Use Only

1-3 Safety Note for Installation

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 8

1-3-2 Electrical Requirements

Symbols on the package:

Keep Up Straight Keep Dry Fragile

Do Not Turn Over Do Not Pile

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 9

1-4 Safety Note for Users

1-4-2 General Note for Users

1-4-3 Safety Principle

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 10

1-4-4 Warning and Precautions (for analyzer)

Danger, do not change the setting of the analyzer

Turn off the analyzer before removing the power plug

Please follow the manufacturer’s instruction and regulation when

Do not use the expired reagent

Incubate the reagent at room temperature when being taken out of

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 11

1-4-6 Warning and Precautions (for operator)

Please note that operation of the analyzer is for authorized

Please contact authorized representative or technical service for the

Be careful not to get scratched when replacing the printing paper.

The ethanol used to clean the analyzer is flammable, and please

Keep the door closed when the analyzer is on

1-4-7 Handling the disposal

Please follow the local security precaution and regulation when

1-4-8 Notice for maintenance and service

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 12

1.5 Exoneration clause

IFU Eng Ver2018033001 Shenzhen Tisenc Medical Devices Co., Ltd 13

Chapter 2 INTRODUCTION OF SYSTEM