Innovance Pfa 200 Im 10 en

INNOVANCE® PFA-200*
System
Instruction Manual
– Instructions for Use –
Manual Version: 1.0

Date of Issue: 2010/06
We reserve the right to make changes in the course of technical development without previous notice.
© 2010 Siemens Healthcare Diagnostics Products GmbH. All rights reserved.
Emil-von-Behring-Str. 76
35041 Marburg
Germany
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval
of Siemens Healthcare Diagnostics Products GmbH.
SMN 10484513
Manual, Order Number: 1 000 1674.0610

Updating
Version Date Changes
Manual Software
1.0 2.0 2010/06 First version
Trademarks Dade, INNOVANCE and PFA-200 are trademarks of Siemens Healthcare

Diagnostics.
*Data Flash is a trademark of Kleinmann GmbH.
*Littelfuse is a trademark of Littelfuse Inc.
*Mikrozid is a trademark of Schülke & Mayr GmbH.
Software Copyrights Software of Siemens Healthcare Diagnostics Products GmbH is the

copyright property of Siemens. All rights to this software are retained by
Siemens. You are entitled to use this software as well as the printed
documentation relating to it on one single, non-transferable workstation.
Disclaimer Siemens Healthcare Diagnostics has validated the provided instructions,

reagents, instrument, software and customizable features for this system to
optimize product performance and meet product specifications. User
defined modifications are not supported by Siemens as they may affect
performance of the system and test results. It is the responsibility of the user
to validate any modifications made to these instructions, instruments,
reagents or software provided by Siemens.
Siemens Healthcare Diagnostics Products GmbH

Emil-von-Behring-Str. 76
35041 Marburg
Germany
www.siemens.com/diagnostics
Chapter overview
Chapter overview
1 Introduction
2 Safe handling
3 Life cycle of the system
4 Description of the hardware
5 Description of the software
6 Configuring the system
7 Preparing for the analysis
8 Performing the analysis
9 Finishing the analysis
10 Cleaning and disinfecting the system
11 Performing maintenance
12 Troubleshooting
13 Appendix
Index
Addendum to the instruction manual
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

Chapter overview
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

Table of contents
Table of contents
1 Introduction 1-1
1.1 Orientation tips 1-1
1.2 Service 1-2
1.3 Warranty 1-2
1.4 Ordering information 1-3
2 Safe handling 2-1
2.1 Intended use 2-1
2.2 Operator qualification 2-1
2.3 General safety information 2-1

2.3.1 Safe handling of the analyzer 2-2
2.3.2 Safe handling of samples, reagents and consumables 2-3
2.4 Quality control (QC) 2-4
2.5 Safety messages 2-4

2.5.1 Signal words in safety messages 2-4
2.5.2 Structure of safety messages 2-5
2.6 Symbols 2-5

2.6.1 Symbols on the analyzer 2-5
2.6.2 Symbols on consumables 2-6
2.7 Statutory requirements 2-7
2.8 Obligations of the system owner 2-7
3 Life cycle of the system 3-1
3.1 Delivery 3-1

3.1.1 Unpacking and checking the delivery 3-1
3.1.2 Scope of delivery 3-1
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0 TOC 1

Table of contents
3.2 Installation 3-2
3.3 Non-operation 3-4
3.4 Disposal 3-4
4 Description of the hardware 4-1
4.1 Analyzer 4-1

4.1.1 Carousel with cartridge cassette 4-2
4.1.2 Trigger solution compartment 4-3
4.1.3 Touch screen 4-3
4.1.4 Printer 4-3
4.1.5 Ports, power switch and fuses 4-4
4.2 Connection of external devices 4-4
4.3 Consumables and accessories 4-5

4.3.1 Cassette 4-5
4.3.2 O-ring 4-5
4.3.3 O-ring service tool 4-5
4.3.4 Priming cartridge 4-5
4.3.5 Vacuum cup 4-5
4.3.6 Target paper 4-6
4.3.7 Cleaning pad 4-6
4.3.8 Printer paper 4-6
4.3.9 USB flash drive 4-6
4.3.10 Stylus 4-6
4.4 Test cartridges and trigger solution 4-6
5 Description of the software 5-1
5.1 Overview 5-1
5.2 Display in the menu Run 5-3
5.3 Display of results 5-4
5.4 Keyboards 5-4

5.4.1 Alphanumeric keyboard 5-5
5.4.2 Numeric keyboard 5-6
TOC 2 INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

Table of contents
5.5 Arrow keys 5-6

5.5.1 Arrow keys in the menu bar 5-6
5.5.2 Arrow keys in lists 5-7
5.6 User rights 5-7
5.7 Software updates 5-7
6 Configuring the system 6-1
6.1 Setting the language 6-1
6.2 Managing user accounts (administrators only) 6-1
6.3 Setting the time and time format (administrators only) 6-3
6.4 Setting the date and date format (administrators only) 6-3
6.5 Setting reference ranges for QC samples and the QC time interval
(administrators only) 6-4
6.6 Setting reference ranges for patient samples (administrators only) 6-5
6.7 Setting the sample ID entry method (administrators only) 6-6
6.8 Setting sounds 6-7
6.9 Setting printer options (administrators only) 6-7
6.10 Setting the LIS type (administrators only) 6-8
6.11 Printing the configuration settings (administrators only) 6-8
7 Preparing for the analysis 7-1
7.1 Preparing the test cartridges 7-1
7.2 Starting the system 7-1
7.3 Logging on 7-1
7.4 Performing a self test and checking for trigger solution dispensing 7-2
8 Performing the analysis 8-1
8.1 Measuring patient samples 8-1

8.1.1 Entering sample information manually 8-1

Table of contents
8.1.1.1 Single test 8-1

8.1.1.2 Duplicate test or two test types, same sample ID 8-2
8.1.1.3 Two tests, different sample ID 8-3
8.1.2 Loading samples 8-4
8.1.3 Running tests 8-5
8.1.4 Canceling running tests 8-6
8.1.5 Removing samples 8-6
8.2 Measuring QC samples 8-7
8.3 Managing results 8-8
8.4 Displaying QC charts 8-11
9 Finishing the analysis 9-1
9.1 Logging off 9-1
9.2 Shutting down the system 9-1
10 Cleaning and disinfecting the system 10-1
10.1 Cleaning the system 10-1
10.2 Disinfecting the system 10-2
11 Performing maintenance 11-1
11.1 Periodic maintenance 11-1
11.2 Maintenance reminders 11-1
11.3 Trigger system 11-2

11.3.1 Loading trigger solution 11-2
11.3.2 Priming the system 11-3
11.3.3 Purging the system 11-3
11.4 O-ring 11-4

11.4.1 Cleaning the o-ring in the analyzer 11-4
11.4.2 Removing the o-ring 11-5
11.4.3 Manually cleaning and inspecting the o-ring 11-6
11.4.4 Installing the o-ring 11-6

Table of contents
11.5 Testing the system for vacuum leaks 11-7
11.6 Printer 11-8

11.6.1 Loading printer paper 11-8
11.6.2 Advancing the printer paper 11-12
11.7 Displaying maintenance events 11-12
11.8 Printing maintenance events 11-13
11.9 Manually adding maintenance events 11-13
11.10 Maintenance history entries 11-14
12 Troubleshooting 12-1
12.1 Displaying errors and getting help 12-1
12.2 Printing errors 12-3
12.3 Turning off the error sound 12-3
12.4 Resetting the system 12-3
12.5 Trigger system 12-3

12.5.1 Checking for trigger solution dispensing 12-3
12.5.2 Exercising the trigger solution pump 12-4
12.6 Vacuum system 12-5

12.6.1 Resetting the syringe 12-5
12.6.2 Exercising the syringe 12-5
12.6.3 Resetting the vacuum chuck 12-5
12.6.4 Exercising the vacuum chuck 12-6
12.7 Carousel 12-6

12.7.1 Resetting the carousel 12-6
12.7.2 Exercising the carousel 12-6
12.8 Incubation system 12-7

12.8.1 Monitoring the temperature 12-7
12.8.2 Testing the incubation system 12-7
12.9 Testing the LCD screen 12-7
12.10 Testing the printer 12-8
12.11 Reading cartridge type codes 12-8

Table of contents
12.12 Installing fuses 12-8
12.13 Error messages 12-9

12.13.1 Common error messages 12-9
12.13.1.1 Air leak 12-10
12.13.1.2 Initial flow obstruction 12-11
12.13.1.3 Flow obstruction when processing the sample 12-11
12.13.1.4 Sample depleted 12-12
12.13.1.5 Maximum syringe travel 12-13
12.13.1.6 Maximum test time 12-14
12.13.2 Other error messages 12-15
13 Appendix 13-1
13.1 Principle of operation 13-1
13.2 Calculation of results 13-3

13.2.1 Mean and coefficient of variation (CV%) for the display of duplicate test results 13-3
13.2.2 Mean, coefficient of variation (CV%) and standard deviation in QC charts 13-3
13.3 Technical specifications 13-4
Index IX-1
Addendum to the instruction manual ADD-1

1 Introduction
1 Introduction
1
This manual describes the use of the INNOVANCE® PFA-200* System in
clinical laboratories.
Note: Depending on the operating system, the selected languages and

regional settings, the screenshots in this manual may differ from the
display on your screen.
This chapter gives orientation tips for using the instruction manual, and
information about service and warranty.
1.1 Orientation tips
Bullets Bullets indicate a list.
Example:
The box contains:

• Monitor
• Keyboard
• Instruction manual
Numbers Numbers indicate a procedure.
Example:
1. Open the box.
2. Check the content.
3. Read the instruction manual.
Arrow An arrow indicates one or more results of an action.
Example:
1. Select Print. p The dialog Print opens.
Bold type Terms used in the software are printed in bold type.
Example:
• Dialog Print
Bold type is also used to put a special emphasis on something.
Example:
This process must never be canceled.
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0 1 1

1 Introduction
Gray note Gray notes indicate important background information.
1 Example:
Note: Once the shift change has been activated, it cannot be

interrupted.
1.2 Service
Siemens and its representatives are available to repair the system after
installation during customary local office hours. Should you require service
at any other time, contact the Siemens service. You will receive information
about how to reach the Siemens service when the system is installed.
Siemens will inform you about the availability and cost of updates.
The scope of agreed service is included in your service contract.
1.3 Warranty
Siemens and its representatives guarantee that the system shows no

defects after installation, and during operation if operated according to this
instruction manual. For further information about warranty adjustments,
contact the Siemens service.
The warranty is not valid for damage that occurs as a consequence of non-
observance of the instruction manual.
Repairs and servicing must only be carried out by persons authorized by

Siemens.
Only carry out maintenance or replacement work as described in the

instruction manual. Improper interventions on the analyzer void the
warranty and can result in service charges.
Limited warranty on wear and tear The warranty is limited for the following wear and tear parts:
parts
• Priming cartridges
• Vacuum cups
• O-rings
• Cleaning pads
• Target paper
• Printer paper
• Fuses
The warranty term for these wear and tear parts is included in your service
contract.
1 2 INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

1 Introduction
1.4 Ordering information
Only original Siemens consumables and spare parts must be used. Order
1
these from your Siemens representative.
For ordering information, see the Siemens product catalog.

1 Introduction

2 Safe handling
2 Safe handling
This chapter describes the intended use of the system and gives general
safety instructions regarding the operation of the system.
2
2.1 Intended use
The intended use of the INNOVANCE PFA-200 system is to aid in the

detection of platelet dysfunction in citrated human whole blood. The system
is for in vitro diagnostic use only.
The system is an analyzer and test cartridge system in which the process
of platelet adhesion and aggregation following a vascular injury is simulated
in vitro. Platelet dysfunction detected by the system may be acquired,
inherited, or induced by platelet inhibiting agents.
If the system is used in any other way than intended:

• All safety precautions may be ineffective.
• Siemens disclaims all liability for any personal injury or damage to the
system which might occur.
System functions The system functions are:

• Moving the carousel (containing cartridges with samples) into the
analyzer
• Reading the type code of the test cartridge
• Dispensing the trigger solution into each test cartridge
• Incubating the samples
• Aspirating the sample through the aperture of the test cartridge
• Measuring the blood flow rate through aperture at a constant vacuum
• Determining the closure time as a function of the blood flow rate
• Calculating and analyzing the readings
• Printing the readings
2.2 Operator qualification
The system must be operated only by persons whose skills, knowledge and
practical experience qualify them to do so, and who have been trained in its
operation.
2.3 General safety information
This analyzer has been inspected before shipment for technical safety. In
order to maintain this status and to ensure hazard-free operation, the user
must follow the hazard and safety instructions contained in this instruction
manual.

2 Safe handling
2.3.1 Safe handling of the analyzer
Operational safety To ensure safe handling of the analyzer, the following instructions on
operational safety must be observed:
2 • Make sure the conditions described in Environmental on page 13-4 are

met.
• Only use Siemens spare parts.
• Never operate the analyzer in an environment containing explosive
mixtures of oxygen, hydrogen or other flammable gases. The analyzer’s
switch contacts generate sparks which can result in ignition of the
mixture.
• If there is visible damage to the analyzer, it must be switched off and
secured against accidental operation.
Electrical safety To ensure safe handling of the analyzer, and to avoid serious risks such as
electric shock or damage by short-circuit, the following instructions on
electrical safety must be observed:
• Make sure the conditions described in Electrical on page 13-4 are met.
• To minimize the danger of an electric shock, use only sockets with a
ground contact (earth) for connecting to the mains supply.
• Never disconnect the ground contacts. There is a danger of electric
shock when the protective conductor is interrupted inside or outside the
analyzer or the ground contact is disconnected from the line.
• Never remove protective guards or fused components because live
parts could be exposed. Electrical connections (plugs, sockets, etc.)
may be live, that means carry an electric charge. Even when the
analyzer is switched off, some components, for example, capacitors,
can be live as they may still be electrically charged. All live parts are a
potential electric shock source.
• To prevent electric shock, switch off and unplug the analyzer before
replacing fuses.
• Never short-circuit the fuse holder.
• All surfaces (for example, floor, worktop) must be dry when you are
working at the analyzer.
• To prevent electric shock, never place containers with liquid on top of the
analyzer as spilled liquid can come in contact with live parts. If liquid is
spilled in the analyzer, disconnect the mains plug.
• Assess the electromagnetic environment prior to operating the analyzer.
It corresponds to CISPR 11 class A. In the event of radio interference in
domestic settings, measures may be necessary to reduce the
interference. The data cable supplied must be used to ensure that the
relevant provisions are complied with. If other external devices such as
a printer or a network are connected, shielded cables and plugs are
essential.
• Do not operate strong electromagnetic transmitters (for example, mobile
phones, walkie-talkies, door openers) in the vicinity of the analyzer.
Electrical fields may disrupt normal operation of the analyzer.

2 Safe handling
Mechanical safety To ensure safe handling of the analyzer, the following instructions on
mechanical safety must be observed:
• Keep clear of moving parts when the analyzer is in operation.
• To prevent the analyzer from tilting or canting due to maladjustment, the
worktop must be stable and horizontal. All of the analyzer's feet must be
in full contact with the worktop.
2
• To avoid damaging the piercing needle for the trigger solution bottle,
close the access door to the trigger solution compartment fully before
pushing the lever down.
Precision and accuracy of test To ensure accuracy and precision of test results, perform a self test and
results check for trigger solution dispensing daily.
Solvents • Only use solvents for cleaning and disinfection which have been
authorized by Siemens.
2.3.2 Safe handling of samples, reagents and consumables
To ensure safe handling of samples, reagents and consumables, the

following safety instructions must be observed:
• Only use approved Siemens reagents and consumables.
• See the instructions for use of the reagents.
• Do not use reagents after their expiry date.
• Do not reuse test cartridges.
Potentially infectious material The samples and reagents, and all parts which come into contact with them
are potentially infectious. Some reagents can irritate skin and mucous
membranes.
• Avoid contact of the skin and mucosa with samples, reagents and with
parts of the analyzer which have come into contact with this material.
• Wear appropriate gloves and safety glasses. Pay attention to the
manufacturer's information regarding the gloves' compatibility with the
materials and liquids used.
Disposal The test cartridges, consumables and the liquid waste are potentially
infectious material.
• Dispose of the test cartridges as described in the appropriate
instructions for use.
• Dispose of the consumables and liquid waste according to laboratory
standards and national regulations.

2 Safe handling
2.4 Quality control (QC)
The system has a self diagnostic built in to verify proper performance. It is

part of the QC practice to perform a self test at least once at the start of each
2
shift and after each startup, see Chapter 7.4. The results of the self test can
be printed along with the date and time for incorporation into the QC
records, see Chapter 6.9.
Blood drawn from healthy adult individuals may be used as normal QC

samples for the system. As part of the system’s QC, Siemens recommends
to test two cartridges of each new lot with a QC donor, or whenever the
institution wishes to verify the performance of the system. See the
instructions for use for further instructions.
Siemens recommends that the laboratory maintains a hard copy of the QC

results. If enabled by the Siemens service, you can also create PDF files of
QC results.
Each laboratory is responsible for the proper storage and retention of

printed and electronic QC records.
2.5 Safety messages
All safety messages must be observed to avoid hazardous situations which

may result in damage to the equipment or in personal injury, illness, or
death.
2.5.1 Signal words in safety messages
The following explains the signal words and their meaning.
Signal word Meaning

Indicates a hazardous situation which, if not avoided, will result in death
DANGER or serious injury
Indicates a hazardous situation which, if not avoided, could result in

WARNING death or serious injury
Indicates a hazardous situation which, if not avoided, may result in minor

CAUTION or moderate injury
Indicates a property damage message

NOTICE
Table 2-1 Signal words

2 Safe handling
2.5.2 Structure of safety messages
The following explains the structure of safety messages.
WARNING 2
In this section, the nature and source of the hazard are stated.
In this section, potential consequences of not avoiding the hazard are
stated.
• In this section, preventive actions to be taken are listed.
• Further preventive action
• …
2.6 Symbols
2.6.1 Symbols on the analyzer
Symbol Meaning
Biological risks
The labeled area can come into contact with potentially infectious
material. The safety instructions regarding infectious material must be
observed.
Waste electrical and electronic equipment

The labeled system must not be treated as unsorted municipal waste.
Waste electrical and electronic equipment must be collected separately,
and returned to the manufacturer.
Ethernet
The system has an ethernet port.
Serial RS-232
The system has a serial RS-232 port.
USB (universal serial bus)
The system has a USB port.
Table 2-2 Symbols on the analyzer

2 Safe handling
2.6.2 Symbols on consumables
Symbol Meaning
Do not reuse
2
Use by
Batch code
Catalogue number
Caution, consult accompanying documents
Manufacturer
Authorized representative in the European Community
Contains sufficient for <n> tests
In vitro diagnostic medical device
Temperature limitation
Consult instructions for use
Non-sterile
CE mark
Contents
Reconstitution volume
Level
Table 2-3 Symbols on consumables

2 Safe handling
2.7 Statutory requirements
CE conformity The instrument bears a CE mark which certifies that the instrument meets
the essential requirements of the following European directives:
• In Vitro Diagnostic Medical Devices Directive 98/79/EC
• European Battery Directive 2006/66/EC
2
• European Directive on Waste Electrical and Electronic Equipment 2002/
96/EC
• European Directive on Restriction of Hazardous Substances 2002/95/
EC
International standards The instrument has been developed, tested and manufactured in
accordance with IEC61010-1, IEC61010-2-081, IEC61010-2-101,
ISO14971, IEC61326-1, IEC61326-2-6, IEC62304, IEC62366.
Electromagnetic compatibility The instrument has been tested in accordance with IEC61326-1 and
(EMC), radio interference IEC61326-2-6. The instrument corresponds to CISPR 11 class A.
suppression and immunity to
interference
2.8 Obligations of the system owner
The system owner takes on the obligations arising from the national right to
operate in vitro diagnostic medical devices.

2 Safe handling

This chapter describes the stages the system goes through, from delivery
to disposal, and the requirements involved for the operator with each stage.
3.1 Delivery
3
3.1.1 Unpacking and checking the delivery
To unpack and check the delivery, proceed as follows:
1. Before opening, check the transport container for signs of external

damage.
2. Open the transport container.
3. Remove the accessory kit.
4. Remove the foam packing.
5. Remove the analyzer from the transport container. There are

indentations on the analyzer that can be used as handles.
6. Remove the plastic wrapping from the analyzer.
7. Open the accessory kit.
8. Check the content for completeness, see Chapter 3.1.2, and intact
condition.
9. If anything is missing or damaged, inform the Siemens service

immediately.
3.1.2 Scope of delivery
The delivery includes:
Analyzer box • 1 INNOVANCE PFA-200 Analyzer

• 1 INNOVANCE PFA-200 Documentation CD Kit
• 1 INNOVANCE PFA-200 Accessory Kit
The documentation CD kit contains:

• 1 INNOVANCE PFA-200 Documentation CD
• 1 INNOVANCE PFA-200 System Note (multilingual)

The accessory kit contains:

• 2 Fuses
• 1 Roll of PFA-200 Printer Paper
• 2 PFA Cassettes
• 1 PFA O-Ring Service Tool
• 2 PFA O-Rings
3 • 2 PFA Priming Cartridges
• 35 PFA Vacuum Cups
• 35 PFA Cleaning Pads
• 100 PFA Target Papers
• 1 USB Flash Drive
• 1 Stylus
Note: The following items are required for operation, but not included in
the delivery and must be ordered separately:
• Power Cord (country-specific)
• Dade® PFA Trigger Solution
• PFA Test Cartridges
Quick starter • 1 INNOVANCE PFA-200 System Quick Starter (language-specific)
Instruction manual (as an option) • 1 INNOVANCE PFA-200 System Instruction Manual (language-specific)
3.2 Installation
To install the system, proceed as follows:
1. Make sure that the electrical and environmental conditions are met, see
Electrical on page 13-4 and Environmental on page 13-4.
WARNING
Misdiagnosis by shortened closure times due to strong vibrations

Death or serious illness may result
• Do not position the system close to where strong vibrations are
generated, for example, large centrifuges.
2. Make sure that the following requirements for the location of the system
are fulfilled:
• Access to a single power outlet within 150cm
• No direct exposure to sunlight

Load printer paper 3. Load printer paper, see Load printer paper on page 11-8.
Connect external devices 4. If you want to save PDF files with test results, plug the USB flash drive
into a USB port and contact the Siemens service with regard to enabling
the creation of PDF files.
Note: Siemens recommends:

• Plugging the USB flash drive into the port on the front of the
analyzer 3
• Plugging the external barcode scanner into one of the USB ports on
the back of the analyzer
5. If required, connect other external devices, see also Chapter 4.2.
Connect power source 6. Plug the power cord into the back of the analyzer.
7. Plug the power cord into the power outlet.
Start system 8. Start the system, see Chapter 7.2.
9. Log on as administrator, see Chapter 7.3. The preset user accounts and
their passwords are listed in Table 3-1.
User ID Password User group

Administrator 23646 Administrator
User 200 User
Table 3-1 Preset users
Load trigger solution 10. Exercise the trigger solution pump, see Chapter 12.5.2, step 3 to step 7.
11. Load trigger solution, see Chapter 11.3.1 and Chapter 11.3.2.
Configure system 12. Configure the system according to the needs of the laboratory, see
Chapter 6.
Note: When configuring the system:

• Change the preset administrator password, see Chapter 6.2
• Set the laboratory-specific measurement ranges for the tests, see
Chapter 6.6
Perform self test 13. Perform a self test, see Chapter 7.4. If the self test is passed without any
error, the system has been installed correctly.

3.3 Non-operation
To prepare the system for a longer period of non-operation, proceed as

follows:
Remove samples and o-ring 1. Remove the samples, see Chapter 8.1.5.
2. Remove the o-ring, see Chapter 11.4.2.

3 Purge system 3. Purge the system, see Chapter 11.3.3.
Log off and shut down system 4. Log off, see Chapter 9.1.
5. Shut down the system, see Chapter 9.2.
Disconnect analyzer 6. Pull out the mains plug from the power outlet.
7. Unplug the power cord from the back of the analyzer.
Disinfect system 8. Disinfect the system, see Chapter 10.2.
Store system 9. Make sure that the storage location meets the non-operating storage
conditions, see Environmental on page 13-4.
10. Transport the system carefully to the storage place.
3.4 Disposal
The disposal of the system is regulated by Directive 2002/96/EC of the

European Parliament and of the Council of 27 January 2003 on waste
electrical and electronic equipment (WEEE), and corresponding national
transpositions.
Siemens is committed to taking back and recycling electrical and electronic

equipment with best practice to support our customers and to protect the
environment.
Depending on the applications, parts of the system may be contaminated

with biohazardous or hazardous chemical material.
WARNING
Infection by contaminated material

• Treat this material according to the applicable safety standards and
regulations.
• Always disinfect the parts before transport or disposal.
• If you need assistance, contact the Siemens service.

NOTICE
Pollution by improper waste disposal

Damage to the environment may result
• Do not treat electrical and electronic equipment as unsorted municipal
waste.
• Collect waste electrical and electronic equipment separately, and return
them to Siemens.
3
To dispose of the system, proceed as follows:
1. Put the system out of operation, see Chapter 3.3.
2. Contact the Siemens service with regard to disposal of the system.


This chapter describes the components of the system and their functions,
and the consumables used on the system.
4.1 Analyzer
The analyzer consists of the following components:

• Carousel with cartridge cassette, see Chapter 4.1.1
• Trigger solution compartment, see Chapter 4.1.2 4
• Touch screen, see Chapter 4.1.3
• Printer, see Chapter 4.1.4
• Ports for external devices, see Chapter 4.1.5
The front and top of the analyzer are shown in Figure 4-1.
1 Integrated printer and printer paper slot

2 Trigger solution compartment
3 Carousel with cartridge cassette
4 USB port
5 Touch screen
Figure 4-1 Front and top of the analyzer

4.1.1 Carousel with cartridge cassette
The carousel is located on the lower front of the analyzer and holds the
cassette containing up to two cartridges for sample testing or system
maintenance.
1 Cartridge
2 Cassette
3 Well for o-ring cleaning pad
4 Carousel
5 Incubation wells
6 Black pads for cartridge type recognition
Figure 4-2 Carousel
After placing samples in one or two test cartridges and starting a test, the
carousel rotates clockwise to the inside of the analyzer to identify the
number and type of test cartridges loaded, dispense the trigger solution into
each test cartridge, incubate the samples and then interface with each test
cartridge to perform the test. When testing is complete, the carousel returns
to the outside position to allow removal of the used test cartridges.

4.1.2 Trigger solution compartment
The trigger solution compartment is located on the right front of the

analyzer. The compartment is opened by lifting the lever all the way up. The
replaceable bottle of trigger solution is located inside this compartment. The
illumination of the trigger solution compartment facilitates reading the
trigger solution level. The amount of trigger solution in the bottle is also
displayed in the software, see Chapter 11.3.1.
1 Access door
2 Trigger solution bottle
3 Lever
Figure 4-3 Trigger solution compartment
4.1.3 Touch screen
The touch screen is located on the upper front of the analyzer and displays
the software user interface.
Screen saver The screen is automatically dimmed after some time of inactivity. The
screen lights up again when it is tapped anywhere.
4.1.4 Printer
The integrated thermoprinter is located on top of the analyzer.

4.1.5 Ports, power switch and fuses
A USB port is located on the front of the analyzer, see Figure 4-1. All other
ports, the power switch and the fuse compartment are located on the back
of the analyzer, see Figure 4-4.
1 Power socket
2 Fuse compartment
3 Power switch
4 Ethernet port
5 RS-232 port
6 USB ports
Figure 4-4 Back of the analyzer
4.2 Connection of external devices
External barcode scanner An external barcode scanner can be connected via the USB ports. The
barcode scanner reads the bar code label placed on the sample tube, the
number is transmitted to the analyzer and is used as the patient ID at the
start of a run. For details, see the instruction manual of the barcode reader.
Laboratory information system A uni-directional LIS can be connected via the serial RS-232 port or the
(LIS) ethernet port. The LIS allows test results to be transmitted from the analyzer
to a host computer.
For details on how to connect the LIS, see Chapter 6.10 and the data
interface manual.

Network (LAN) The analyzer can be connected to a network via the ethernet port.
USB flash drive A USB flash drive can be connected via the USB ports. If enabled by the
Siemens service, the software can generate PDF files of test results that are
saved on the USB flash drive.
4.3 Consumables and accessories
Instructions for using the consumables are given in the respective

procedures.
4
4.3.1 Cassette
The cassette is a plastic compartment with two openings to position either

test cartridges or priming cartridges. The cassette together with the
cartridges is placed into the incubation wells of the carousel, see Figure 4-2.
4.3.2 O-ring
O-rings are black rubber rings located in the analyzer. They serve to seal
the test cartridge during measurement.
4.3.3 O-ring service tool
The o-ring service tool is a plastic compartment with two pits. It is used to
insert the o-ring into the analyzer and to remove it.
4.3.4 Priming cartridge
Priming cartridges are light blue cups used to prime the system, check the
system for vacuum leaks and check for trigger solution dispensing.
4.3.5 Vacuum cup
Vacuum cups are small grayish-blue cups which are inserted into the
priming cartridges. They are used to check the system for vacuum leaks
and to check for trigger solution dispensing. Each check requires a new
vacuum cup.

4.3.6 Target paper
Target papers are small white cardboard pieces showing a target. They can
be used optionally to facilitate the check for trigger solution dispensing.
They are placed on top of the vacuum cups in the priming cartridges. Each
check requires a new target paper.
4.3.7 Cleaning pad
Cleaning pads are white circular foam sponges. They are used to clean the
4 o-ring in the analyzer. Each cleaning process requires a new cleaning pad.
4.3.8 Printer paper
The lifetime of the printer paper allows for storing printed results and results
of self tests for 5 years.
4.3.9 USB flash drive
The USB flash drive can be used to save PDF files with test results. The
function needs to be enabled by the Siemens service.
4.3.10 Stylus
The stylus can be used to facilitate selecting software functions on the touch
screen.
4.4 Test cartridges and trigger solution
Detailed descriptions of the test cartridges and trigger solution, their

handling, applications and performance are provided in the instructions for
use.

This chapter describes the structure and the general operation of the
software.
5.1 Overview
An overview of the software is shown in Figure 5-1.
2 2 5
7 5
1 Menu bar
2 Menu bar, scrolling arrows
3 Software functions
4 Status bar
5 Status bar, date and time
6 Status bar, status messages
7 Status bar, status symbol
Figure 5-1 Overview of the software

Menu bar with scrolling arrows The software functions are grouped in 8 menus. The menu bar shows 3
menu names at a time. You can browse through all available menu names
using the blue scrolling arrows, see Table 5-4. To display a menu, tap its
name.
Software functions This area shows the software functions available in the menu. Operating the
software functions is described in the respective procedures.
Status bar, status symbol In the status bar, on the left, a green, yellow or red symbol indicates the
status of the system. The status symbols are explained in Table 5-1.
Symbol Explanation
System is running without any problems
5 • Maintenance is due, see also Chapter 11.2

• System is eventually operational (for example,
warming up)
An error condition prevents system operation (for example,
a vacuum leak)
Table 5-1 Explanation of status symbols
Status bar, status messages In the middle, green, yellow and red status messages may be displayed.
Examples are shown in Table 5-2. The colors of the status messages
correspond to the colors of the status symbol, see Table 5-1. You can get
information on most status messages by tapping them. For detailed
information on errors, see Chapter 12.
Status message Explanation

A USB flash drive is connected to the
analyzer
A printout is being formatted and transmitted

to the printer, the system is inactive
The incubation system is heated, the current

temperature is displayed
No test cartridge in position A
Table 5-2 Examples for status messages
Status bar, date and time On the right, the date and time are displayed.

5.2 Display in the menu Run
During a test, information is displayed in the menu Run, see Figure 5-2.
5
7
4
3 5
2
8
1 Next possible user action (start, stop or clear test) or wait status (three dots)
2 Logged on user
3 Displayed cartridge position is shown in blue, inactive cartridge position in gray
4 Active sample type (patient or QC)
5 Sample ID (entered by the user or assigned by the software)
6 Patient information (optional)
7 Results as available in the course of the test, see Chapter 5.3
8 Individual phases of the test with their status, status symbols are explained in Table 5-1
Figure 5-2 Display in the menu Run
The green status messages associated with testing are explained in

Table 5-3. For information on error messages, see Chapter 12.
Status message Explanation

[IH] Remaining incubation time in seconds
[SA] Test time already passed for position A in seconds
[SB] Test time already passed for position B in seconds
Table 5-3 Status messages displayed during a test

5.3 Display of results
Examples for the display of results in the menu Run are shown in Figure 5-3
and Figure 5-4.
1 2 3 4
6
5
1 Cartridge position
2 Detected cartridge type
3 Measured closure time
5 4 Reference range flag L (below reference range) or H (above reference
range)
5 Error code
6 Additional error information for some errors, see also Chapter 12.13.1
Figure 5-3 Example for the display of results for a single test
For a duplicate test without errors, mean and CV% are calculated and
displayed.
Figure 5-4 Example for the display of results for a duplicate test
5.4 Keyboards
To enter text, for example, sample IDs or patient information, the software
displays either a numeric or an alphanumeric keyboard.

5.4.1 Alphanumeric keyboard
The special keys on the alphanumeric keyboard are explained in

Figure 5-5.
1 2
7 6 5 4 3
1 Backspace key, deletes the last character

2 Changes to a numeric keyboard
3 Exit key
4 Enter key
5 Space key, inserts a space
6 Alt key, displays additional characters in some languages
7 Shift key, displays all letters in upper case
Figure 5-5 Alphanumeric keyboard

5.4.2 Numeric keyboard
The special keys on the numeric keyboard are explained Figure 5-6.
1 2
5
3
1 Backspace key, deletes the last character

2 Changes to an alphanumeric keyboard
3 Enter key
4 Exit key
Figure 5-6 Numeric keyboard
5.5 Arrow keys
5.5.1 Arrow keys in the menu bar
In the menu bar, scrolling arrows are used to file through the available
menus. The different scrolling arrows are explained in Table 5-4.
Scrolling arrow Explanation

Next menu to the left
Far left end of the menu bar has been reached
Next menu to the right
Far right end of the menu bar has been reached
Table 5-4 Scrolling arrows in the menu bar

5.5.2 Arrow keys in lists
In lists, scrolling arrows are used to file through the available list items. The
scrolling arrows are explained in Table 5-5.
Scrolling arrow Explanation

Page up
Line up
Line down
5
Page down
Table 5-5 Scrolling arrows in lists
5.6 User rights
The software has 4 different access levels and corresponding user groups
that determine the available user rights, see Table 5-6.
Access level/user group User rights

Not logged in (Logoff) Displaying the result list, error list and maintenance history, shutdown
User All rights except:
• Configuring the system with the exception of setting the language and
sounds
• Changing factory settings
Administrator All rights except changing factory settings
Service, Siemens All rights
Table 5-6 Access levels and user groups
5.7 Software updates
Software updates are performed via a USB flash drive. Instructions on how
to perform an update are distributed with the corresponding USB flash
drive.


This chapter describes how to configure laboratory- and user-specific

settings for the system.
6.1 Setting the language
In the dialog Language, you can choose from the following languages:
• English
• French
• German
• Italian
• Spanish
To set the language, proceed as follows:

6
1. In the menu Configure, tap Language. p The dialog Language is
displayed.
2. Tap the arrow buttons to select the language.
3. Tap Select. p The language is set.
6.2 Managing user accounts (administrators only)
In the dialog User Accounts, you can manage up to 20 users accounts.

You can:
• Add new user accounts
• Edit existing user accounts
• Delete existing user accounts
To open the dialog, proceed as follows:
1. In the menu Configure, tap Users. p The dialog User Accounts is

displayed.
Add user account To add a new user account, proceed as follows:
1. Tap Select. p The dialog Edit User is displayed.
2. Tap User ID. p A keyboard is displayed.
3. Tap the keys required.
4. Tap the enter key.

5. Tap Group until the required user group is displayed. Tapping this
button changes between the available user groups. The user group
determines the available access rights, see Chapter 5.6.
6. Tap Password. p A keyboard is displayed.
7. Tap the keys required. If you do not want to set a password, skip this
step.
9. Tap Save. p The user account is added.
Edit existing user accounts To edit existing user accounts, proceed as follows:
1. Tap the arrow buttons to select the user account.
6 To edit the user ID:
3. Tap User ID. p A keyboard is displayed.
To edit the user group:
6. Tap Group until the required user group is displayed. Tapping this
button changes between the available user groups. The user group
determines the available access rights, see Chapter 5.6.
To edit the password:
7. Tap Password. p A keyboard is displayed.
8. Tap the keys required. If you do not want to set a password, skip this
step.
10. Tap Save. p The settings are changed.
Delete user accounts To delete a user account, proceed as follows:
1. Tap the arrow buttons to select the user account. The user account
which is currently logged cannot be deleted.
3. Tap Delete. p The user account is deleted.

6.3 Setting the time and time format (administrators only)
In the dialog Time, you can:

• Choose between 12-hour and 24-hour time format
• Set the time
To set the time format and the time, proceed as follows:
1. In the menu Configure, tap Time. p The dialog Time is displayed.
Set time format To set the time format:
2. Tap the required time format. p The active format is displayed in blue,
the inactive format in gray.
Set time To set the time:
3. Tap Hour. p A keyboard is displayed.
4. Tap the keys required. Even if the time format is set to 12-hour, you must
6
enter the hour in 24-hour format. This is how the software recognizes if
the hour is AM or PM.
6. Tap Minute. p A keyboard is displayed.
9. Tap Save. p The time and the time format are set.
6.4 Setting the date and date format (administrators only)
In the dialog Date, you can:

• Set the date
• Choose between different date formats
To set the date and the date format, proceed as follows:
1. In the menu Configure, tap Date. p The dialog Date is displayed.
Set date To set the date:
2. Tap Year. p A keyboard is displayed.
5. Tap Month. p A keyboard is displayed.

8. Tap Day. p A keyboard is displayed.
Set date format To set the date format:
11. Tap the required date format. The abbreviations are explained in
Table 6-1. p The active format is displayed in blue, the inactive formats
in gray.
Abbreviation Meaning Examples

dd Day in 2 digits 01
6 31
mm Month in 2 digits 02
12
yyyy Year in 4 digits 2010
Table 6-1 Abbreviations in date formats
12. Tap Save. p The date and the date format are set.
6.5 Setting reference ranges for QC samples and the QC time interval (administrators
only)
In the dialog QC Setup you can:

• Set your laboratory-specific reference ranges for QC samples, any QC
result outside the reference range is flagged with an L (below range) or
an H (above range)
• Set your laboratory-specific QC time interval (in hours)
When the QC time interval has expired after the last QC sample has been
measured for a specific test type, the QC symbol is displayed in

the status bar to remind you to measure a QC sample again. When the
symbol is displayed, no system functions are inhibited. The symbol is just a
visual reminder.
To set the reference ranges for QC samples and the QC time interval,
proceed as follows:
1. In the menu Configure, tap QC Setup. p The dialog QC Setup is

displayed.

Set reference ranges for QC To set a reference range for QC samples:

samples
2. Tap the test type.
3. Tap Select. p The dialog Edit Range is displayed.
4. Tap High Limit. p A keyboard is displayed.
7. Tap Low Limit. p A keyboard is displayed.
10. Tap Save. p The reference range is set.
Set the QC time interval To set the QC time interval:

6
11. Tap QC Interval. p A keyboard is displayed.
12. Tap the keys required to set the QC time interval in hours. If you do not
want to be reminded, tap 0 (zero).
13. Tap the enter key. p The QC time interval is set.
6.6 Setting reference ranges for patient samples (administrators only)
In the dialog Reference Ranges, you can set your laboratory-specific

reference ranges for patient samples. Any test result outside the reference
range is flagged with an L (below range) or an H (above range).
To set a reference range, proceed as follows:
1. In the menu Configure, tap Reference Ranges. p The dialog

Reference Ranges is displayed.
2. Tap the test type.
3. Tap Select. p The dialog Edit Range is displayed.
4. Tap High Limit. p A keyboard is displayed.
7. Tap Low Limit. p A keyboard is displayed.

10. Tap Save. p The reference range is set.
6.7 Setting the sample ID entry method (administrators only)
In the dialog Sample ID entry method, you can choose between two ways
to ensure the assignment of sample IDs. When no sample ID has been
entered by the user and a test is started, the software can either:
• Request the user to enter a sample ID (Required)
• Assign a sample ID automatically (Automatic)
Automatically assigned sample IDs are created using the position of the
sample and the date and time when the measurement starts. The sample
ID format is:
6 Pyyyymmdd_hhm2m2ss
The abbreviations are explained in Table 6-2.
Abbreviation Meaning
P Position of the sample in the cassette
yyyy Year in 4 digits
mm Month in 2 digits
dd Day in 2 digits
hh Hours in 2 digits and in 24-hour format
m2m2 Minutes in 2 digits
ss Seconds in 2 digits
Table 6-2 Abbreviations in the sample ID format
Examples for automatically assigned sample IDs:
A20100217_230529
B20101103_074708
To set the sample ID entry method, proceed as follows:
1. In the menu Configure, tap Sample ID. p The dialog Sample ID

entry method is displayed. The active method is displayed in blue, the
inactive method in gray.
2. Tap Automatic or Required. p The active method is displayed in blue,

the inactive method in gray.
3. Tap Save. p The sample ID entry method is set.

6.8 Setting sounds
In the dialog Sounds/Audio, you can set a tone to sound when an error
occurs and when a key is tapped. The error tone will sound periodically until
any button is tapped.
To open the dialog, proceed as follows:
1. In the menu Configure, tap Sounds/Audio. p The dialog Sounds/

Audio is displayed.
Set error sound To set the error sound:
2. Tap Alarm Volume. p A keyboard is displayed.
3. Tap the keys required. To disable the error sound, tap 0 (zero).
5. To test the set volume, tap Test on the right. p The alarm tone sounds. 6
Set key sound To set the key sound:
6. Tap Key Volume. p A keyboard is displayed.
7. Tap the keys required. To disable the key sound, tap 0 (zero).
8. To test the set volume, tap Test on the right. p The key tone sounds.
Note: Siemens recommends enabling a tone to sound when a key is

tapped.
10. Tap Save. p The sounds are set.
6.9 Setting printer options (administrators only)
In the dialog Printer Options, you can:

• Set the number of trailing lines between printouts
• Choose to print or not to print the results of self tests
To set the printer options, proceed as follows:
1. In the menu Configure, tap Printer Options. p The dialog Printer

Options is displayed.
Set number of trailing lines To set the number of trailing lines:
2. Tap Trailing Lines. p A keyboard is displayed.

3. Tap the keys required. You can set numbers between 2 and 22.
Set if results of self tests are To set if the results of self tests are printed or not:
printed or not
5. Tap Self Test. p If printing is active, Self Test is displayed in blue,
otherwise in gray.
6. Tap Save. p The number of trailing lines and the setting for printing the
results of self tests are set.
6.10 Setting the LIS type (administrators only)
If the system is connected to a LIS, you can set the LIS type in the dialog
LIS Setup. For details regarding the connection of the LIS, see the data
interface manual.
6 To set the LIS type, proceed as follows:
1. In the menu Configure, tap LIS Setup. p The dialog LIS Setup is
displayed.
2. Tap the required LIS type.
3. Tap Save.
6.11 Printing the configuration settings (administrators only)
To print the current configuration settings, proceed as follows:
1. In the menu Configure, tap Print. p The dialog Print Configuration

Settings is displayed.
2. Tap Yes. p The green printer icon is displayed in the status bar. The
configuration settings are printed.

This chapter describes how to prepare the system before performing the
analysis. For collection and handling of the blood samples, see the
instructions for use.
7.1 Preparing the test cartridges
For details on use, applications and performance of the different cartridge

types, see the instructions for use.
To prepare the test cartridges, proceed as follows:
1. Take the test cartridges out of the refrigerator to let them warm up to
room temperature. This will take at least 15min.
You must now start the system.
7.2 Starting the system

7
To start the system, proceed as follows:
1. Set the power switch on the back of the analyzer to position I. p The
analyzer initializes and checks critical functions for correct operation.
The software starts and displays the menu Maintenance. In the status
bar, the yellow status message [IH] indicates that the incubation system
is checked and heated. The maintenance symbol indicates

that a self test must be performed.
Note: When starting the analyzer from cold, it takes at least 15min to
reach the operating temperature.
You must now log on.
7.3 Logging on
To log on, proceed as follows:
1. In the menu Maintenance, tap User ID. p The dialog User ID is

displayed.
2. Tap the arrow buttons to select the user ID.
3. Tap Select. p A keyboard is displayed.
4. Tap the keys required for the password.

5. Tap the enter key. p The user is logged on. The user ID is displayed
above User ID.
Note: If an incorrect password is entered, the user ID is not displayed.
You must now perform a self test and check for trigger solution dispensing.
7.4 Performing a self test and checking for trigger solution dispensing
During a self test:

• The o-ring is cleaned in the analyzer using cleaning pads
• The incubation system is tested
• The system is checked for vacuum leaks
• The system is primed
• The trigger system is tested
7
You will need:
• 2 new grayish-blue vacuum cups
• 2 blue priming cartridges
• New cleaning pad (circular foam sponge)
• Bottle of isopropanol
• Tweezers
• Optional: new target paper
To perform a self test, proceed as follows:
Perform self test 1. When starting the analyzer from cold: Wait until the yellow status
message [IH] in the status bar disappears. The analyzer has then
reached operating temperature.
2. In the menu Maintenance, tap System Check. p The dialog System

Check is displayed.
3. Tap Self Test. p The dialog Self Test is displayed.
4. Insert a new vacuum cup into each priming cartridge.
5. Load the priming cartridges in position A and B.
6. Optional: Place a new target paper on top of the vacuum cup in position
B.
7. Tap Continue. p The self test starts. The current status is displayed.
8. Load a new cleaning pad in the carousel well.
9. Apply 4 to 5 drops of isopropanol to the center of the cleaning pad.

10. With a gloved index finger, tap gently on the cleaning pad 2 to 3 times to
help distribute the isopropanol.
11. Tap Continue.
12. Using tweezers, remove the cleaning pad.
13. Discard the cleaning pad in a suitable biohazard waste container.
14. Tap Continue. p When the self test is finished, a corresponding

message is displayed and the maintenance symbol disappears. If
printing the results of self tests is activated, the results are printed.
15. Tap Continue.
Check trigger solution 16. Remove the cassette carefully from the carousel.
dispensing
17. Visually check the trigger solution dispensing in position B, see
Table 7-1.
Using target paper Without using target paper

View the target paper on top of the vacuum cup. View the raised platform of the vacuum cup.
7
Check if the trigger solution is dispensed in the Check if the trigger solution is dispensed on the raised
target circle and touches the black dot in the center platform of the vacuum cup. The size and exact centering
of the target. The size and exact centering of the of the drop is not critical. If there is a drop visible on the
drop is not critical. platform, the trigger solution dispensing is adequate.
If the drop does not touch the center of the target, If there is no drop visible on the platform, contact the
contact the Siemens service. Siemens service.
Table 7-1 Checking the trigger solution dispensing
Remove consumables 18. Remove the priming cartridges.
19. Remove the vacuum cup and, if applicable, the target paper from both
priming cartridges with a gloved index finger.

20. Discard the vacuum cups and, if applicable, the target paper in a
suitable biohazard waste container.
21. Rinse both priming cartridges with distilled or deionized water.
22. Save the priming cartridges for further use.
Add trigger test to maintenance If the trigger solution has been dispensed correctly:
history
23. In the menu Help, tap History. p The maintenance history is displayed
on the left.
24. Tap Add Event. p The dialog Add Event - History is displayed.
25. Tap M100 Trigger Test Verified.
26. Tap Select. p The dialog Select is displayed.
27. Tap Yes. p The trigger test is added to the maintenance history.
If the self test is passed without any error, you can now perform tests.
If the self test fails with the error message VL200 (vacuum test fail):
7 • Clean the o-ring manually, see Chapter 11.4.2 to Chapter 11.4.4
• Repeat the self test, it is not sufficient to perform a leak test

This chapter describes how to measure patient samples and QC samples,

from entering the samples information to viewing the evaluation of the
measurement.
8.1 Measuring patient samples
Prior to performing tests, the sample information (sample ID and optionally

patient data) must be entered. There are three ways to do this:
• Manually
• Sample ID is assigned automatically by the software, see Chapter 6.7,
it is not possible to enter patient data
Note: You can only run duplicate tests if you enter the sample IDs
manually.
8.1.1 Entering sample information manually
8.1.1.1 Single test 8

To enter the sample information for a single test manually, proceed as
follows:
Sample ID 1. In the menu Run, tap Sample ID . p A keyboard is

displayed.
3. Verify that the correct sample ID has been entered.
4. Tap the enter key. p The sample ID is set.
Patient data If you want to enter patient data, proceed with the following steps.
5. Tap Patient . p A keyboard is displayed.
6. Tap the keys required for the patient ID.
8. If you want to enter the patient name, tap the keys required, otherwise
skip this step.

skip this step.
11. Tap the enter key. p The patient data is set.
8.1.1.2 Duplicate test or two test types, same sample ID
To enter the sample information for a duplicate test or two different test
types with the same sample ID manually, proceed as follows:
Sample ID for position A 1. In the menu Run, tap Sample ID . p A keyboard is

displayed.
4. Tap the enter key. p The sample ID is set for position A.
Patient data for position A If you want to enter patient data, proceed with the following steps, otherwise
go to step 12.
5. Tap Patient . p A keyboard is displayed.
8 6. Tap the keys required for the patient ID.
skip this step.
10. If you want to enter the patient location, tap the keys required, otherwise
skip this step.
Sample ID and patient data for 12. Tap B . p The dialog Position B is displayed.
position B
Note: If you do not enter a sample ID for position B, but load a cartridge
in position B, the software will assign the sample ID automatically and
run the test.
13. Tap Yes. p B is displayed in blue. The sample ID and the patient data
are set for position B.

8.1.1.3 Two tests, different sample ID
To enter the sample information for two tests (same test type or different
ones) with two different sample IDs manually, proceed as follows:
Sample ID for position A 1. In the menu Run, tap Sample ID. p A keyboard is displayed.
Patient data for position A If you want to enter patient data for position A, proceed with the following
steps, otherwise go to step 12.
5. Tap Patient. p A keyboard is displayed.
6. Tap the keys required for the patient ID.
skip this step.
10. If you want to enter the patient location, tap the keys required, otherwise
8
skip this step.
Sample ID and patient data for 12. Tap B. p The dialog Position B is displayed.
position B
Note: If you do not enter a sample ID for position B, but load a cartridge
in position B, the software will assign the sample ID automatically and
run the test.
13. Tap No. p B is displayed in blue.
14. Repeat step 1 to step 4 for position B.
15. If you want to enter patient data, repeat step 5 to step 11 for position B.

8.1.2 Loading samples
To load samples, proceed as follows:
1. Peel off and discard the top foil seal of the test cartridge, see Figure 8-1.
Figure 8-1 Peeling off the top foil seal of a test cartridge
2. Place a test cartridge in position A (left position) of the cassette and
8 push until it snaps securely in place.
3. When running duplicates or two tests: Snap a second test cartridge into
position B (right position).
Note: When testing two different patient samples, note their respective
position in the cassette (A or B).
WARNING
Infection by infectious samples

• Avoid contact with samples.
• Wear appropriate protective equipment.
• Handle the samples in accordance with good laboratory practices.
4. Resuspend the samples by gently inverting the collection tube 3 to 4

times by hand.

5. Holding the cassette with the test cartridges on a flat surface, pipette
800µL of sample into the sample reservoir opening of the test
cartridges, see Figure 8-2. Dispense slowly along one of the inside
corners.
Figure 8-2 Inserting sample into a test cartridge
Note: To minimize the risk of trapping an air bubble, place the tip of the
pipette against one of the inside corners of the opening while slowly
pipetting in the sample.
6. Place the cassette with the test cartridges into the incubation wells of the
carousel so that the cassette is flush to the carousel surface. Do not
apply pressure to the sample reservoir openings. 8
8.1.3 Running tests
To run tests, proceed as follows:
Start test 1. Tap Start . p Start changes to Stop. The tests start and can
take up to 9min for a single test or 14min for two tests. Status messages,
errors and results are displayed, see Chapter 5.2. When the test is
finished, Stop changes to … (3 dots). The results and errors associated
with the test are stored and printed. If a LIS is connected, the results and
errors are transmitted to the LIS. … (3 dots) change to Clear.
Clear test 2. Tap Clear . p Information related to the test is cleared from
the display. Clear changes to Start.

8.1.4 Canceling running tests
To cancel running tests, proceed as follows:
Stop test 1. Tap Stop. p The dialog Stop Testing is displayed.
2. Tap Yes. p Stop changes to … (3 dots). The results and errors

associated with the test are stored and printed. If a LIS is connected, the
results and errors are transmitted to the LIS. … (3 dots) change to
Clear.
Clear test 3. Tap Clear. p Information related to the test is cleared from the display.
Clear changes to Start. If QC samples have been measured, the
sample type changes from QC to Patient and the button Cartridge Lot
changes to Patient.
Note: Do not reuse test cartridges of canceled tests.
8.1.5 Removing samples
To remove samples, proceed as follows:
WARNING
8 Infection by infectious samples
• Avoid contact with samples.
• Handle the samples in accordance with good laboratory practices.
1. Wait until the carousel has moved to load position.
2. Remove the cassette carefully from the carousel.
3. Hold the cassette in one hand and gently pull the bottom of the test
cartridge toward you until it unsnaps.
4. Discard the test cartridges in a suitable biohazard waste container.

8.2 Measuring QC samples
To measure QC samples, proceed as follows:
1. In the menu Run, tap Sample Type. p The sample type changes from
Patient to QC.The button Patient changes to Cartridge Lot.
Sample ID for position A 2. Tap Sample ID. p A keyboard is displayed.
6. Tap Cartridge Lot. p The dialog Cartridge Lot is displayed, listing the
cartridge lots which have already been entered for previous
measurements. If the QC time interval has expired for a specific test
type, the symbol is displayed.
Select cartridge lot for position A If the cartridge lot has already been entered for a previous measurement,
proceed with the next step, otherwise go to step 9.
7. Tap the arrow buttons to select the cartridge lot.
8. Tap Select. p The cartridge lot is set.

8
Enter lot number for position A If the cartridge lot has not yet been entered for a previous measurement:
9. Tap Add Entry. p A keyboard is displayed.
11. Tap the enter key. p The lot number is set.
Sample ID and cartridge lot for If you want to run a second QC sample, proceed with the next step,
position B otherwise go to step 14.
12. Tap B. p The sample type changes back from QC to Patient. The
button Cartridge Lot changes back to Patient.
13. Repeat step 1 to step 11 for position B.
Perform test 14. Load the samples, see Chapter 8.1.2.
15. Run the tests, see Chapter 8.1.3.
If you want to cancel a running test, see Chapter 8.1.4.
16. Remove the samples, see Chapter 8.1.5.

8.3 Managing results
In the dialog Results, you can:

• Reprint results
• Create PDF files of results (if enabled by the Siemens service)
• Retransmit results to the LIS (if a LIS is connected)
You can display the dialog Results:

• For the current test (before the test is cleared): in the menu Run
• For previous tests: in the menu Results
Current test To display the dialog Results for the current test, proceed as follows:
1. In the menu Run, tap A or B to select the required position.
2. Tap Result. p The dialog Results is displayed.
Most recent tests To display the dialog Results for one of the most recent tests, proceed as
follows:
1. In the menu Results, tap Patient or QC to select the required sample

type. p The corresponding tests are displayed on the left.
8 2. Tap the arrow buttons to select the test.
3. Tap Select. p The detail dialog for the test is displayed.
Older tests To display the dialog Results for older tests, you can search by date, parts
of test types and:
• For patient samples: by any part of sample ID, patient ID or patient name
• For QC samples: by any part of sample ID or lot number
To do this, proceed as follows:
1. In the menu Results, tap Patient or QC to select the required sample

type. p The corresponding tests are displayed on the left.
2. Tap Search. p The dialog Search: Patient or Search: QC is

displayed.
To search by test type, sample ID, patient ID, patient name or lot number,
proceed with the next step. To search only by date, go to step 6.
3. Tap Match. p A keyboard is displayed.

4. For patient samples, tap the keys required for any part of a sample ID,
patient ID, patient name or test type except Col. For QC samples, tap
the keys required for any part of sample ID, lot number or test type
except Col. Capitalization is irrelevant. Examples are shown in
Table 8-1.
Search for Tap the keys

Results for patient ID 1705 1705
Results for both patient IDs 1700 and 1705 170
Results for both patient IDs 1718 and 1705 17
Note: The search results will also include all matching sample IDs.
Table 8-1 Examples for search matches
To search from a start date in the past, proceed with the next step. To search
from the current date, go to step 9.
6. Tap Start Date. p A keyboard is displayed.
7. Tap the keys required. The date format must correspond to the date
shown at the bottom right in the status bar, using dots instead of slashes.
Example:
8
Date shown in the status bar: 2010/05/02
Date to enter: 2010.05.02
Note: If an incorrect date has been entered, the software inserts the
current date.
9. Tap Search. p The dialog Search: Patient or Search: QC is

displayed, showing the most recent search results.
10. Tap the arrow buttons to select the test.
11. Tap Select. p The detail dialog for the test is displayed.
Manage results In the dialog Results, proceed as follows:
To reprint the results:
1. Tap Print. p The result and errors associated with the test are
reprinted.

To save a PDF file of the results to a plugged in USB flash drive (if enabled
by the Siemens service):
1. Tap Create PDF. p The PDF file is saved to a plugged in USB flash
drive.
Note: Always follow your laboratory’s procedures for the proper storage
and retention of printed and electronic test results and patient data.
The PDF file names are created using the sample ID, and the date and time
when the PDF file is created. The format of the file names is:
S_yyyymmddhhm2m2ss
The abbreviations are explained in Table 8-2.
Abbreviation Meaning
S Sample ID
yyyy Year in 4 digits
mm Month in 2 digits
dd Day in 2 digits
8 hh
m2m2
Hours in 2 digits and in 24-hour format
Minutes in 2 digits
ss Seconds in 2 digits
Table 8-2 Abbreviations in the file name format
Examples for file names:
A20100217_230529_20100217231529
23.abc_20101103074708
To retransmit the results to the LIS (if a LIS is connected):
1. Tap Retransmit to LIS. p The results are retransmitted to the LIS.
Print test list You can print a list of tests which were found using the search function. To
do this:
1. Generate the test list using the search function, see Older tests on
page 8-8, step 1 to step 9.
2. In the dialog Search: Patient or Search: QC, tap Print. p The green
printer icon is displayed in the status bar. The test list is printed.

8.4 Displaying QC charts
In the menu QC, you can display QC charts. You can search for QC charts
by test type and by date.
A QC chart shows:
In the diagram:
• All QC results with a non-zero closure time
• The set reference range for QC samples in green
Below the diagram:

• The set reference range for QC samples in numbers
• Mean, CV% and the standard deviation calculated for the displayed data
QC chart last shown To display the QC chart last shown, proceed as follows:
1. Display the menu QC. p The QC chart last shown is displayed. On the
right, above Cartridge Lot, the test type and the lot number are
displayed.
QC chart for most recently To display a QC chart for the most recently measured QC samples, proceed
measured QC samples as follows:
1. In the menu QC, tap Cartridge Lot. p The dialog Cartridge Lot is
displayed, showing at the top the cartridge lots for which the last QC
8
samples have been measured.
3. Tap Select. p The QC chart for the cartridge lot is displayed.
QC chart for previously measured To display a QC chart for previously measured QC samples, you can search
QC samples by test type and date. To do this, proceed as follows:
1. In the menu QC, tap Search. p The dialog Search - Cartridge Lot is
displayed.
2. Tap Match until the required test type is displayed. Tapping this button
changes between the available test types and an empty button. If the
button is empty, all test types are searched for.

Example:
current date.
6. Tap Search. p The dialog Search - Cartridge Lot is displayed,

showing the most recent search results.
8. Tap Select. p The QC chart for the cartridge lot is displayed.
Zoom in on QC chart To evaluate the data in the QC chart, you can zoom in on the y-axis which
displays the closure time.
To zoom in and out on the y-axis, proceed as follows:
1. Tap the QC chart anywhere. p The y-axis is enlarged by one zooming
8 step.
2. To zoom in further, tap the QC chart a second time. p The y-axis is

enlarged by another zooming step.
3. To revert to the original size, tap the QC chart a third time. p The y-axis
reverts to the original size.

This chapter describes how to shut down the analyzer after performing the
analysis.
9.1 Logging off
To log off, proceed as follows:
1. In the menu Run or Configure, tap User ID. p The dialog User ID is
displayed.
2. Tap Logoff. p You are logged off.
9.2 Shutting down the system
Note: Siemens recommends:

• Leaving the system running between shifts
• Shutting down the system once a week
To shut down the system, proceed as follows:
Shut down software 1. In the menu Shutdown, tap Shutdown. p The dialog System
Shutdown is displayed. 9
2. Tap Yes. p The dialog System Shutdown is displayed, asking if you
want to lock the carousel.
3. If the system is to be transported to another location for storage, or to be

prepared for a longer period of non-operation: Tap Yes. Otherwise tap
No. p The system is shut down. When shutdown is completed, a
corresponding message is displayed.
Switch off analyzer 4. Set the power switch on the back of the analyzer to position O.


This chapter describes how to clean and disinfect the system.
NOTICE
Damage to the touch screen by incorrect cleaning and disinfection

Touch screen may be blinded or scratched
• To clean the touch screen, only use isopropanol or ethanol.
• To disinfect the touch screen, only use a special screen disinfectant, for
example, Kleinmann Data Flash* 1722.
• Do not use standard disinfectants, for example, Mikrozid*.
• Do not wipe the touch screen with a scratching or hard material.
NOTICE
Damage to the analyzer by sterilization

Analyzer may break down
• Never sterilize the analyzer.
10.1 Cleaning the system
WARNING
Electric shock by spilled liquid 10

Death or serious injury may result
• Do not immerse the analyzer into liquid.
• Do not pour liquid on the analyzer.
• Do not place containers with liquid on top of the analyzer.
To clean the touch screen, lightly wipe it using a soft cloth moistened with
isopropanol or ethanol. Dry remaining liquid with a soft cloth, preferably a
microfiber cloth.
To clean all other surfaces, wipe them using a cloth moistened with a
commercial disinfectant, for example, Mikrozid. To remove blood stains, use
a cloth moistened with water. Keep the black pads for cartridge type
recognition clean. They are located on the surface of the carousel
underneath the cassette.
The o-ring must be cleaned manually at periodic intervals, see

Chapter 11.1.

10.2 Disinfecting the system
The analyzer and used parts (for example, the cassette) must be disinfected
daily at the end of the shift.
When disinfecting, wherever possible, use a wipe method instead of a spray

method to apply the disinfectant solution. If a spray method is used, ensure
that droplets of solution, rather than a mist, are expelled from the container.
To disinfect the analyzer, proceed as follows:
WARNING
Infection by contaminated parts

• Disinfection must only be performed by qualified laboratory personnel.
• Handle the potentially contaminated parts in accordance with good
laboratory practices.
Remove samples 1. As debris buildup typically occurs on the areas around the test
cartridges, remove the samples, see Chapter 8.1.5.
Disconnect analyzer 2. Set the power switch on the back of the analyzer to position O.
3. Unplug the power cord from the back of the analyzer.
Disinfect touch screen 4. Apply a special screen disinfectant, for example, Kleinmann Data Flash
1722 to the touch screen and allow the disinfectant to sit for 1min.
10 5. Dry remaining liquid with a soft cloth, preferably a microfiber cloth.
Disinfect all other surfaces 6. Apply a commercial disinfectant solution, for example Mikrozid, on
areas where there is visible contamination with blood, blood products or
other body fluids.
7. If heavy buildup is visible, soften the debris by applying disinfectant

solution on the area, letting it sit, then wiping up with a paper towel or
other absorbent material.
8. Apply disinfectant solution on the area again and allow it to sit for 20min.
9. Apply disinfectant solution to all external surfaces and allow it to sit for
20min, then rinse with distilled or deionized water.
10. Discard the used paper towels or other wiping material in a suitable
biohazard waste container.

This chapter describes how to perform maintenance and replacement work.
Only carry out maintenance or replacement work as described here.

Improper interventions on the analyzer void the warranty and can result in
service charges.
11.1 Periodic maintenance
Periodic maintenance actions are listed in Table 11-1.
Interval Action See

Daily, start of shift or after system has Perform self test and check for trigger Chapter 7.4
been running for 24h solution dispensing
Daily, end of shift Disinfect analyzer and used parts Chapter 10.2
Weekly Clean o-ring manually Chapter 11.4.2 to Chapter 11.4.4
Yearly Replace o-ring Chapter 11.4.2 to Chapter 11.4.4
Table 11-1 Maintenance list
11.2 Maintenance reminders
When certain actions are due, the software displays a maintenance icon in
the status bar. The maintenance icons are explained in Table 11-2.
Maintenance icon Explanation

One of the following maintenance actions is due:
• Self test (after each startup and after the system has been running for 24h)
• Priming (after loading trigger solution) 11
• O-ring installation (after o-ring removal)
• Leak test (after o-ring removal and installation)
• Manual o-ring cleaning (weekly)
Trigger solution bottle is not present
Printer paper is out

Paper loading lever is rotated up
Measuring a QC sample is due for at least one test type (visual reminder, system
functions are not inhibited)
Table 11-2 Maintenance icons

11.3 Trigger system
11.3.1 Loading trigger solution
You will need:

• New trigger solution bottle
Note: The trigger solution level displayed in the menu Maintenance

above Trigger Solution is calculated, not detected. Therefore, if a
bottle is loaded which is not full, the displayed trigger solution level is
incorrect.
To load trigger solution, proceed as follows:
1. Pull the lever above the access door of the trigger solution compartment
all the way up. p The access door opens.
2. Remove the trigger solution bottle. It is normal for some residual solution
to remain in the bottle.
3. Verify that the trigger solution in the new bottle is not turbid and no
particulate matter is present.
4. Remove the flip-top cap from the bottle.
5. Insert the bottle with the label on the back side.
6. Close the access door fully.
NOTICE
Damage to the piercing needle when access door is not fully closed
11 The piercing needle for the trigger bottle may become distorted or break
• Close the access door fully before pushing the lever down.
7. Push the lever all the way down.
8. In the menu Maintenance, tap Trigger Solution. p The dialog Trigger

Solution is displayed.
9. Tap Change Bottle. p The dialog Change Bottle is displayed.
10. Tap Yes. p The trigger solution level is set to 100.0%. The level is
displayed above Trigger Solution.
You must now prime the system, see Chapter 11.3.2.

11.3.2 Priming the system
Priming clears the system of any bubbles trapped when changing the
trigger solution bottle or caused by the outgassing of the trigger solution.
You will need:

• Blue priming cartridge
To prime the system, proceed as follows:
1. In the menu Maintenance, tap Trigger Solution. p The dialog Trigger

2. Tap Prime. p The dialog Prime is displayed.
3. Check if the bottom foil of the priming cartridge is intact.
4. Load the priming cartridge in position A.
5. Tap Continue. p Priming starts. The current status is displayed. When

priming is finished, a corresponding message is displayed.
6. Tap Continue.
7. Remove the cassette from the carousel.
8. Remove the priming cartridge.
9. Discard the trigger solution accumulated in the priming cartridge.
10. Rinse the priming cartridge with distilled or deionized water.
11. Save the priming cartridge for further use.
11.3.3 Purging the system

11
Purging clears the system of trigger solution, for example, to prepare the
system for non-operation.
You will need:

To purge the system, proceed as follows:
Remove trigger solution bottle 1. Pull the lever above the access door of the trigger solution compartment
2. Remove the trigger solution bottle.
3. Close the access door.
Purge system 4. In the menu Maintenance, tap Trigger Solution. p The dialog Trigger

5. Tap Purge. p The dialog Purge is displayed.
8. Tap Continue. p Purging starts. The current status is displayed. When

purging is finished, a corresponding message is displayed.
9. Tap Continue.
11.4 O-ring
11.4.1 Cleaning the o-ring in the analyzer
You will need:

• New cleaning pad (circular foam sponge)
• Tweezers
To clean the o-ring in the analyzer, proceed as follows:
11 1. In the menu Maintenance, tap O-Ring. p The dialog O-Ring

Maintenance is displayed.
2. Tap Clean O-Ring. p The dialog Clean O-Ring is displayed. The

carousel rotates to the loading position for the cleaning pad.
3. Load a new cleaning pad in the carousel well.
4. Apply 4 to 5 drops of isopropanol to the center of the cleaning pad.
5. With a gloved index finger, tap gently on the cleaning pad 2 to 3 times to
help distribute the isopropanol.
6. Tap Continue. p The o-ring cleaning starts. The current status is

displayed. When the cleaning is finished, a corresponding message is
displayed.
7. Using tweezers, remove the cleaning pad from the carousel well.

8. Inspect the cleaning pad for dirt and debris.
9. Discard the cleaning pad in a suitable biohazard waste container.
10. Tap Continue.
If the cleaning pad is dirty, you must now clean the o-ring manually and, if
required, change it, see Chapter 11.4.2 to Chapter 11.4.4.
11.4.2 Removing the o-ring
You will need:

• O-ring service tool
To remove the o-ring from the analyzer, proceed as follows:
1. In the menu Maintenance, tap O-Ring. p The dialog O-Ring

2. Tap Remove O-Ring. p The dialog Remove O-Ring is displayed.
3. Place the o-ring service tool into the incubation wells of the carousel so
that the cassette is flush with the carousel surface.
4. Tap Continue. p The o-ring is placed in position A of the o-ring service

tool. The current status is displayed. When the removal is finished, a
corresponding message is displayed.
5. Remove the o-ring service tool from the carousel.
6. Tap Continue.
7. Invert the o-ring service tool and tap it against the palm of your gloved
hand to remove the o-ring.
You must now clean the o-ring manually and inspect it, see Chapter 11.4.3. 11

11.4.3 Manually cleaning and inspecting the o-ring
WARNING
Infection by contaminated parts

• Avoid contact with potentially contaminated parts.
• Wear appropriate protective equipment when performing o-ring
maintenance.
• Handle the potentially contaminated parts in accordance with good
laboratory practices.
You will need:

• Lint-free cloth
To manually clean and inspect the o-ring, proceed as follows:
1. Rinse the o-ring under distilled or deionized water. Place it between

forefinger and thumb and remove any debris by using a rubbing motion
while rinsing.
2. Visually inspect the o-ring for debris or unusual wear and tear such as
cracks.
3. If the o-ring requires replacement: Discard it in a suitable biohazard

container.
4. If the o-ring is intact: Shake excess distilled or deionized water off and
dry the o-ring with a lint-free cloth.
You must now install a clean or new o-ring, see Chapter 11.4.4.
11
11.4.4 Installing the o-ring
You will need:

• O-ring service tool
• Clean or new o-ring
To install the o-ring, proceed as follows:
1. Check if the surface in position B of the o-ring service tool is free of

debris.
2. If required, clean the surface in position B with isopropanol.
3. In the menu Maintenance, tap O-Ring. p The dialog O-Ring


4. Tap Install O-Ring. p The dialog Install O-Ring is displayed.
5. Load a clean or new o-ring in position B of the o-ring service tool.
6. Place the o-ring service tool into the incubation wells of the carousel so
that the cassette is flush with the carousel surface.
7. Tap Continue. p The o-ring is installed. The current status is

displayed. When the installation is finished, a corresponding message is
displayed.
8. Tap Continue.
9. Remove the o-ring service tool from the carousel.
10. Store the o-ring service tool in the packaging provided.
11. Add the o-ring cleaning or replacement manually to the maintenance

history, see Chapter 11.9.
To verify that the system has no vacuum leak, you must now perform a leak
test, see Chapter 11.5.
11.5 Testing the system for vacuum leaks
You will need:

• New grayish-blue vacuum cup
To test the system for vacuum leaks, proceed as follows:
1. In the menu Maintenance, tap Vacuum System. p The dialog

Vacuum System is displayed.
2. Tap Leak Test. p The dialog Leak Test is displayed.

11
3. Insert the new vacuum cup into the priming cartridge.
5. Tap Continue. p The system is tested for vacuum leaks. The current
status is displayed. When the test is finished, a corresponding message
is displayed.
6. Tap Continue.
9. Remove the vacuum cup from the priming cartridge with a gloved index
finger.

10. Discard the vacuum cup in a suitable biohazard waste container.
11.6 Printer
11.6.1 Loading printer paper
You will need:

• Roll of printer paper
To load printer paper, proceed as follows:
Load printer paper 1. Open the printer door at the top of the analyzer.
Figure 11-1 Opening printer door
11
2. Remove the empty paper roll.

3. Load the paper roll between the mounting tabs in the door with the loose
paper end on the bottom.
Figure 11-2 Loading paper roll
4. Rotate the paper loading lever up.
11
Figure 11-3 Rotating paper loading lever up

5. Cut or tear the paper end at a slight angle.
Figure 11-4 Paper end
6. Thread in the paper end below the black roll and pull the paper through
the top.
11
Figure 11-5 Threading the paper into the printer

7. Rotate the paper loading lever down.
Figure 11-6 Rotating paper loading lever down
8. Thread the paper end through the slot in the printer door.
11
Figure 11-7 Threading the paper through the printer door
9. Close the printer door.
10. Tear off the excess paper.

11.6.2 Advancing the printer paper
To advance the printer paper by one line, proceed as follows:
1. In the menu Maintenance, tap Display/ Printer. p The dialog

Display/ Printer is displayed.
2. Tap Paper Advance. p The printer paper is advanced.
11.7 Displaying maintenance events
Most recent maintenance events To display the most recent maintenance events, proceed as follows:

on the left.
2. Tap the arrow buttons to select the maintenance event.
3. Tap Select. p The detail dialog for the maintenance event is displayed,
showing the maintenance event code at the top right, a detailed
description in the middle and the user ID at the bottom.
Older maintenance events To display older maintenance events, you can search by date and by any
part of a maintenance event code. To do this:

on the left.
2. Tap Search. p The dialog Search: History is displayed.
To search by any part of a maintenance event code, proceed with the next
step. To search only by date, go to step 6.
11 4. Tap the keys required for any part of a maintenance event code.
Capitalization is irrelevant. Examples are shown in Table 11-3.

Manually entered maintenance events m
Events Weekly Maintenance Completed m120

Example:
current date.
9. Tap Search. p The dialog Search: History is displayed, showing the

most recent search results.
10. Tap the arrow buttons to select the maintenance event.
11. Tap Select. p The detail dialog for the maintenance event is displayed,
showing the maintenance event code at the top right, a detailed
description in the middle and the user ID at the bottom.
11.8 Printing maintenance events
You can print a list of maintenance events which were found using the
search function. To do this, proceed as follows:
1. Generate the maintenance event list using the search function, see
Older maintenance events on page 11-12, step 1 to step 9.
2. In the dialog Search: History, tap Print. p The green printer icon is
displayed in the status bar. The maintenance events are printed.
11
11.9 Manually adding maintenance events
You must manually enter certain maintenance actions which the software
cannot detect. To do this, proceed as follows:

on the left.
2. Tap Add Event. p The dialog Add Event - History is displayed.
3. Tap the arrow buttons to select the maintenance action.
4. Tap Select. p The dialog Select is displayed.
5. Tap Yes. p The maintenance action is added to the maintenance

history.

11.10 Maintenance history entries
Maintenance Description Select details

event code
C501 Temperature Sensor Factory calibrated the Temperature sensor.
Calibrated
C502 Type Code Sensor Calibrated Factory calibrated the Type Code sensor.
C503 AIL Sensor Calibrated Factory calibrated the Air in Line (AIL) sensor.
C504 Pressure Sensor Calibrated Factory calibrated the Pressure sensor.
C505 Pump Calibrated Factory calibrated the Trigger Solution pump.
I100 Temperature Test Pass Incubation heater temperature test was successfully performed.
M100 Trigger Test Verified User verified that the trigger solution was correctly applied to the
cartridge.
M110 O-Ring Cleaned The O-Ring was removed, inspected, cleaned and reinstalled.
M120 O-Ring Replaced The used O-Ring was removed and a new O-Ring was installed.
M500 PM Performed Factory performed a preventive maintenance procedure.
M510 Instrument Repaired Factory repaired and adjusted instrument to meet product
specifications.
S000 Instrument Power On System was turned on.
S100 Instrument Configuration One or more instrument configuration parameters were
Change changed.
S190 Self Test Pass System self test was successfully performed.
S500 Software Update Instrument software was changed or updated.
S999 Instrument Shutdown System was shutdown successfully.
T100 Bottle Changed Trigger Solution bottle level was reset to 100%
T110 Trigger Test Performed Trigger Solution dispense test was performed.
T120 Trigger Solution Primed Trigger solution prime operation performed.
11 T130 Trigger Solution Purged Trigger solution purge operation performed.
V110 O-Ring Cleaned O-Ring cleaning operation preformed.
V120 O-Ring Removed O-Ring removal operation preformed.
V130 O-Ring Installed O-Ring installation operation preformed.
V190 Vacuum Leak Test Pass Vacuum leak test was successfully performed.
Table 11-4 Maintenance history entries

12 Troubleshooting
12 Troubleshooting
This chapter describes the troubleshooting system of the software. The

troubleshooting system is based on status messages displayed in the
status bar.
12.1 Displaying errors and getting help
Errors are displayed in the middle of the status bar as red symbols showing
the error code.
Current errors To display and get help on a current error, proceed as follows:
1. Close all open dialogs.
2. Tap the corresponding red status message in the status bar. p The
detail dialog for the error is displayed, showing the error code at the top
right, a detailed description in the middle and the user ID at the bottom.
3. Tap Help. p Instead of the error, help instructions to remedy the error
are displayed.
4. To switch between both displays, tap Help again.
Most recent errors To display the most recent errors and get help on them, proceed as follows:
1. In the menu Help, tap Errors. p The error list is displayed on the left.
2. Tap the arrow buttons to select the error.
3. Tap Select. p The detail dialog for the error is displayed, showing the
error code at the top right, a detailed description in the middle and the
user ID at the bottom.
are displayed.
Older errors To display older errors, you can search by date and by any part of an error
12
code. To do this, proceed as follows:
1. In the menu Help, tap Errors. p The error list is displayed on the left.
2. Tap Search. p The dialog Search: Errors is displayed.
To search by any part of an error code, proceed with the next step. To
search only by date, go to step 6.

12 Troubleshooting
4. Tap the keys required for any part of an error code. Capitalization is
irrelevant. Examples are shown in Table 12-1.

Errors on the incubation heater ih
Errors Incubation Heater Fail, ih210
Temperature too low.
Example:
current date.
9. Tap Search. p The dialog Search: Errors is displayed, showing the

most recent search results.
10. Tap the arrow buttons to select the error.
12 11. Tap Select. p The detail dialog for the error is displayed, showing the
error code at the top right, a detailed description in the middle and the
user ID at the bottom.
are displayed.

12 Troubleshooting
12.2 Printing errors
You can print a list of errors which were found using the search function. To
do this, proceed as follows:
1. Generate the error list using the search function, see Older errors on
page 12-1, step 1 to step 9.
2. In the dialog Search: Errors, tap Print. p The green printer icon is
displayed in the status bar. The errors are printed.
12.3 Turning off the error sound
If an error sound is enabled, it sounds periodically when an error occurred.

To turn off the error sound for this error:
1. Tap any key.
Note: To disable the error sound permanently, see Chapter 6.8.
12.4 Resetting the system
Resetting the system remedies a number of errors, as detailed in the

corresponding help messages.
To reset the system, proceed as follows:
1. In the menu Maintenance, tap Reset. p The system is reset. Red

status messages disappear. If all errors are remedied, the status symbol
at the bottom left changes from a red square to a yellow triangle or a
green circle.
2. If errors still exist, reset the system again.
3. If errors persist, contact the Siemens service.
12
12.5 Trigger system
12.5.1 Checking for trigger solution dispensing
You will need:

• 2 new grayish-blue vacuum cups
• 2 blue priming cartridges
• Optional: new target paper

12 Troubleshooting
To check both cartridge positions for trigger solution dispensing, proceed as

follows:
1. In the menu Maintenance, tap System Check. p The dialog System

Check is displayed.
2. Tap Trigger Test. p The dialog Trigger Test is displayed.
3. Insert a new vacuum cup into each priming cartridge.
4. Load the priming cartridges in position A and B.
5. Optional: Place a new target paper on top of the vacuum cup in each
position A and B.
6. Tap Continue. p The trigger test starts. The current status is

displayed. When the trigger test is finished, a corresponding message
is displayed.
7. Tap Continue.
8. Remove the cassette carefully from the carousel.
9. Check the trigger solution dispensing in position A and B, see Table 7-1.
10. Remove the priming cartridges.
11. Remove the vacuum cup and, if applicable, the target paper from both
priming cartridges with a gloved index finger.
12. Discard the vacuum cups in a suitable biohazard waste container.
13. Rinse both priming cartridges with distilled or deionized water.
14. Save the priming cartridges for further use.
12.5.2 Exercising the trigger solution pump
You will need:

12 • Blue priming cartridge
To exercise the trigger solution pump, proceed as follows:
Remove trigger solution bottle 1. Pull the lever above the access door of the trigger solution compartment
2. Remove the trigger solution bottle.
Exercise trigger solution pump 3. In the menu Maintenance, tap Trigger Solution. p The dialog Trigger
4. Tap Exercise. p The dialog Pump Exercise is displayed.

12 Troubleshooting
7. Tap Start. p The trigger solution pump performs 300 pump cycles. The
current cycle is displayed in status bar.
You can stop the test at any time. To do this, tap Stop.
12.6 Vacuum system
12.6.1 Resetting the syringe
To reset the syringe, proceed as follows:

2. Tap Syringe Test. p The syringe is reset.
12.6.2 Exercising the syringe
To exercise the syringe, proceed as follows:

2. Tap Syringe Exercise. p The dialog Syringe Exercise is displayed.

12
3. Tap Start. p The syringe is moved 10 times up and down. The current
cycle is displayed in the status bar.
You can stop the exercise at any time. To do this, tap Stop.
12.6.3 Resetting the vacuum chuck
To reset the vacuum chuck, proceed as follows:

2. Tap Chuck Test. p The vacuum chuck is reset.

12 Troubleshooting
12.6.4 Exercising the vacuum chuck
To exercise the vacuum chuck, proceed as follows:

2. Tap Chuck Exercise. p The dialog Chuck Exercise is displayed.
3. Tap Start. p The vacuum chuck is moved 10 times up and down. The
current cycle is displayed in the status bar.
12.7 Carousel
12.7.1 Resetting the carousel
To reset the carousel, proceed as follows:
1. In the menu Maintenance, tap Sample Carousel. p The dialog

Sample Carousel is displayed.
2. Tap Drive Test. p The carousel is reset.
12.7.2 Exercising the carousel
To exercise the carousel, proceed as follows:
1. In the menu Maintenance, tap Sample Carousel. p The dialog

Sample Carousel is displayed.
2. Tap Exercise. p The dialog Carousel Exercise is displayed.
3. Tap Start. p The carousel rotates 10 times to the test position and back
12 to the load position. The current cycle is displayed in the status bar.

12 Troubleshooting
12.8 Incubation system
12.8.1 Monitoring the temperature
To monitor the temperature of the incubation system, proceed as follows:
1. In the menu Maintenance, tap Temperature. p The dialog

Temperature is displayed.
2. Tap Monitor. p The dialog Temperature Monitor is displayed.
3. Tap Continue. p The system monitors the temperature in the

incubation wells for 120s. The current status is displayed. When the test
is finished, a corresponding message is displayed, showing the
maximum, minimum and average of the recorded temperature values.
4. Tap Continue.
12.8.2 Testing the incubation system
To test the incubation system, proceed as follows:
1. In the menu Maintenance, tap Temperature. p The dialog

Temperature is displayed.
2. Tap Test. p The dialog Temperature Test is displayed.
3. Tap Continue. p The temperature of the incubation system is

temporarily changed and monitored. The current status is displayed.
When the test is finished, a corresponding message is displayed.
4. Tap Continue.
12.9 Testing the LCD screen
To test the function of the LCD screen, proceed as follows:

12
2. Tap LCD Test. p The test starts, showing the whole screen in different
colors.
3. Check if the screen shows only one color at a time. p When the test is
finished, the screen reverts to the last display.

12 Troubleshooting
12.10 Testing the printer
To test the printer, proceed as follows:

2. Tap Printer Test. p The green printer icon is displayed in the status
bar. A test printout is printed.
12.11 Reading cartridge type codes
To view the last type code reading and to read the type code of cartridges
positioned in the system, proceed as follows:
1. In the menu Maintenance, tap Type Code Sensor. p The dialog Type
Code Sensor is displayed, showing the last type code reading.
2. To read the type code only for one position, tap A or B. p Positions
which are read are displayed in blue, positions which are not read in
gray.
3. Tap Scan. p The type codes are read 10 times and the display is
updated correspondingly.
You can stop reading the type codes at any time. To do this, tap Scan.
12.12 Installing fuses
You will need:

• 2 small screw drivers
• 2 new fuses
To install fuses, proceed as follows:
Disconnect analyzer 1. Set the power switch on the back of the analyzer to position O.
12 2. Unplug the power cord from the back of the analyzer.
WARNING
Electric shock by contact with live parts

Death or serious injury may result
• Unplug the power cord before opening the analyzer.

12 Troubleshooting
Install fuses 3. Using 2 small screw drivers, pry open the fuse compartment on the back
of the analyzer, see Figure 12-1.
Figure 12-1 Prying open the fuse compartment
4. Carefully remove the fuse holder.
5. Place the fuse holder face down.
6. Remove the used fuses.
NOTICE
Damage to the analyzer by inadequate fuses

Analyzer may break down
• Only use new fuses from the accessory kit or ordered from the Siemens
product catalog for the system.
7. Insert new fuses.
8. Put the fuse holder back into the fuse compartment. Push in all the way.
Reconnect analyzer 9. Plug the power cord into the analyzer.

12
You must now start the system, see Chapter 7.2 to Chapter 7.4.
12.13 Error messages
12.13.1 Common error messages
The following section lists the most common errors, the circumstances in
which they occur and how to proceed afterwards.

12 Troubleshooting
12.13.1.1 Air leak
Error code SV300
Test result --- s Invalid Test Air Leak
Explanation The system has detected an initial air leak in the vacuum system. This
condition is detected only at the beginning of a test.
Causes • No sample in the test cartridge

• Air entrapped in test cartridge when sample was loaded
• Vacuum leak in the system
• Malfunctioning trigger solenoid pump
• Defective test cartridge
Solutions and comments • Verify that the sample was added to the test cartridge.
• Perform a self test without the cleaning pad to test the vacuum system
and the trigger system, see Chapter 7.4.
If the leak test fails:

• Cleaning or replacing the o-ring may correct the vacuum leak. Remove
the o-ring, clean it manually and inspect it, reinstall the clean o-ring or
replace it, see Chapter 11.4.2 to Chapter 11.4.4. Rerun the leak test,
see Chapter 11.5.
• If the leak test passes, rerun the test with a new cartridge and sample
with appropriate sample volume (800µL).
• If the problem persists, contact the Siemens service.
If the trigger test fails:

• A malfunctioning solenoid pump may be the cause for the air leak.
Contact the Siemens service.
Result interpretation Non-reportable
12

12 Troubleshooting
12.13.1.2 Initial flow obstruction
Error code SS210
Test result --- s Invalid Test Flow Obstruction
Explanation The system has detected a sudden stoppage of blood flow at the start of a
test. See the instructions for use, section Limitations of Procedure, for
further information.
Causes The system failed to establish the initial blood flow rate specifications after
the first 30s of testing and aborts the run. This condition may be caused by:
• Microthrombin in the sample, or particulates introduced into the sample
or test cartridge from the environment
Solutions and comments • Verify that the sample does not contain clots or aggregates. If no
aggregates are visible, repeat once to rule out a defective cartridge.
• A sample that results in repeated flow obstruction may have resulted
from problems during blood collection. Recollect the blood sample and
repeat the test.
• If the problems persist, contact the Siemens service.
12.13.1.3 Flow obstruction when processing the sample
Error code SS211
Test result The result is reported at the time the flow obstruction occurs, for example,
>93 s No Closure Flow Obstruction
Explanation The system has detected a sudden stoppage of blood flow during a test run.
See the instructions for use, section Limitations of Procedure, for further
information.
Causes The system detected a flow obstruction after the initial blood flow rate
specifications have been established. This condition may be caused by: 12
• Capillary or the test cartridge membrane aperture is suddenly plugged
by micro aggregates that may form during the test or by particulates
introduced into the sample or test cartridge from the environment
Solutions and comments • Verify that the sample does not contain clots or aggregates. If no
aggregates are visible, repeat once to rule out a defective cartridge.
• A sample that results in repeated flow obstruction may have resulted
from problems during blood collection. Recollect the blood sample and
repeat the test.
• If the problems persist, contact the Siemens service.

12 Troubleshooting
12.13.1.4 Sample depleted
Error code SS220
Test result The result is reported at the time the error occurs, for example,
>287 s No Closure Sample Depleted
Explanation The system has detected air being drawn subsequent to the first 30s of
testing. This condition is detected whenever the test runs out of sample and
closure of the aperture has not occurred.
Causes • Not enough sample loaded in the test cartridge

• Sufficient sample in the test cartridge, but closure did not occur due to
platelet dysfunction and/or low sample viscosity (low hematocrit, high
sedimentation rate)
Solutions and comments • Verify that 800µL was added to the cartridge. Rerun the sample using
900µL.
• Verify that the sample hematocrit is within normal range. See the
instructions for use, section Limitations of Procedure, for further
information. An abnormal hematocrit may impair platelet function and
result in prolongation of the closure time. Platelet dysfunction in
combination with a low hematocrit will often induce this type of error.
Samples from patients treated with platelet antagonist drugs may exhibit
characteristics that cause this type of error. Adding additional specimen
(up to 900µL) could eliminate the insufficient sample message, but a
combination of low hematocrit and platelet dysfunction will most likely
result in a closure time >300s.
• The test cartridge cup serves as the receptacle where blood is collected
after it passes through the membrane aperture. During a test, the
vacuum chuck interfaces with the cup and comes in close proximity to
blood. Air that is drawn into the cup whenever an insufficient sample
occurs can cause blood to foam and contaminate either the vacuum
chuck or o-ring. To avoid potential contamination, it is recommended to
clean the o-ring in the analyzer, see Chapter 11.4.1.
Result interpretation A sample depleted message that occurs at a time that is greater than the
upper limit of the reference range may indicate abnormal platelet function
12 due to the reasons stated above. In such cases this result may be reported
as the time in which the test ended, >xxxs, with a statement qualifying the
properties of the sample (that is, abnormal hematocrit and/or low platelet
count) and suspicion of platelet dysfunction.

12 Troubleshooting
12.13.1.5 Maximum syringe travel
Error code SV210
Test result The result is reported at the time the error occurs, for example,
>287 s No Closure Maximum Syringe Travel
Explanation The system has stopped the current test because the syringe has reached
the end of its travel prior to maximum test time.
Causes • Syringe piston moved too far too quickly as a result of low sample
viscosity
• Sufficient sample in the test cartridge, but closure did not occur due to
platelet dysfunction and/or low viscosity (low hematocrit, high
sedimentation rate)
• Defective test cartridge caused a small vacuum leak
• Dirt or debris on the vacuum seal between the system and the test
cartridge caused a small vacuum leak
• System malfunction caused a small vacuum leak
Solutions and Comments • To rule out vacuum leaks, perform a leak test, see Chapter 11.5.
• If the leak test fails, cleaning or replacing the o-ring may correct the
vacuum leak. Remove the o-ring, clean it manually and inspect it,
reinstall the clean o-ring or replace it, see Chapter 11.4.2 to
Chapter 11.4.4. Rerun the leak test, see Chapter 11.5.
• If the leak test is passed, the system is in control. Verify the sample
hematocrit before performing a second test. If the hematocrit is
abnormal, the sample may have low viscosity which may induce platelet
dysfunction. See the instructions for use, section Limitations of
Procedure, for further information. An abnormal hematocrit may impair
platelet function and result in prolongation of the closure time. Platelet
dysfunction in combination with low hematocrit will often induce this type
of error. Samples from patients treated with platelet GPIIb/IIIa
antagonist drugs may exhibit characteristics that may induce this type of
error. Adding additional specimen (up to 900µL) could eliminate
maximum syringe travel, but will most likely result in a closure time
>300s. If the repeat result confirms the abnormality, platelet dysfunction
may be suspected possibly due to abnormal hemodynamic properties of
the sample and/or anti-platelet agents.
12
Result interpretation A maximum syringe travel message that occurs at a time that is greater than
the upper limit of the reference range may indicate abnormal platelet
function. The result may be reported as >xxxs only if the time lies above
the reference range. The report should include a statement qualifying the
abnormal qualities of the sample and suspicion of platelet dysfunction.

12 Troubleshooting
12.13.1.6 Maximum test time
Error code SV220
Test result >300 s No Closure Maximum Test Time
Explanation The sample did not achieve closure of the aperture within the maximum
time for a test (>300s, not including the incubation period).
Causes • Sample with abnormal platelet function resulting in non-closure (NC) of

the aperture
• Vacuum leak in the system
Solutions and comments If an NC is obtained with a normal donor QC sample or the result does not
agree with the patient’s clinical history, a possible vacuum leak may be
suspected.
• To rule out vacuum leaks, perform a leak test, see Chapter 11.5.
• If the leak test fails, cleaning or replacing the o-ring may correct the
vacuum leak. Remove the o-ring, clean it manually and inspect it,
reinstall the clean o-ring or replace it, see Chapter 11.4.2 to
Chapter 11.4.4. Rerun the leak test.
• If the leak test is passed, a defective test cartridge may have caused the
vacuum leak. Rerun the sample with new cartridge to verify the result. If
the second test confirms the error, then most likely this is an abnormal
sample.
Result interpretation Report as CT>300s, abnormal platelet function as confirmed by retest.
12

12 Troubleshooting
12.13.2 Other error messages
Error Description Select Details Help Details

code
DB300 Database Error Error while reading from database. If error continues, contact Service for
assistance.
DB301 Database Error Error while writing to database. If error continues, contact Service for
assistance.
DC110 Carousel Drive Fail Carousel cannot find Home Check for obstruction and then press
position. Reset on the Maintenance screen. If error
continues, contact Service for assistance.
DC120 Carousel Drive Fail Carousel stuck on Home position. Check for obstruction and then press
Reset on the Maintenance screen. If error
DC230 Carousel Drive Fail Carousel encoder/motor position Check for obstruction and then press
problem. Reset on the Maintenance screen. If error
DC300 Carousel Drive Fail Carousel servo drive controller Recycle power. If error continues, contact
problem. Service for assistance.
DC400 Carousel Drive Fail Carousel servo drive controller Recycle power. If error continues, contact
timeout. Service for assistance.
DP100 No Paper Paper not detected on printer. Check paper supply and replace if needed.
If error continues, contact Service for
assistance.
DP200 No Paper Paper not detected on printer while Check paper supply and replace if needed.
printing. If error continues, contact Service for
assistance.
DS110 Syringe Pump Drive Syringe Pump cannot find Home Reset on the Maintenance screen. If error
Fail position. continues, contact Service for assistance.
DS120 Syringe Pump Drive Syringe Pump stuck on Home Reset on the Maintenance screen. If error
Fail position. continues, contact Service for assistance.
DS230 Syringe Pump Drive Syringe Pump encoder/motor Reset on the Maintenance screen. If error
Fail position problem. continues, contact Service for assistance.
DS300 Syringe Pump Drive
Fail
Syringe Pump servo drive controller Recycle power. If error continues, contact
problem. Service for assistance. 12
DS400 Syringe Pump Drive Syringe Pump servo drive controller Recycle power. If error continues, contact
Fail timeout. Service for assistance.
DV110 Vacuum Chuck Vacuum Chuck cannot find Home Reset on the Maintenance screen. If error
Drive Fail position. continues, contact Service for assistance.
DV120 Vacuum Chuck Vacuum Chuck stuck on Home Reset on the Maintenance screen. If error
DV130 Vacuum Chuck Vacuum Chuck cannot find Seal Reset on the Maintenance screen. If error
DV140 Vacuum Chuck Vacuum Chuck stuck on Seal Reset on the Maintenance screen. If error
Table 12-2 Other error messages

12 Troubleshooting

code
DV300 Vacuum Chuck Vacuum Chuck stepper drive Recycle power. If error continues, contact
Drive Fail controller problem. Service for assistance.
DV400 Vacuum Chuck Vacuum Chuck stepper drive Recycle power. If error continues, contact
Drive Fail controller timeout. Service for assistance.
IH210 Incubation Heater Temperature too low. Contact Service for assistance.
Fail
IH220 Incubation Heater Temperature too high. Contact Service for assistance.
Fail
IH300 Incubation Heater Temperature control not Contact Service for assistance.
Fail responding.
IH500 Incubation Heater Temperature sensor needs Contact Service for assistance.
Fail calibration.
LC200 Communications ACK timeout from Host. 1. Check LIS status.
Error
2. Check for intermittent cable issue.
3. Confirm ACK from Host .
LC300 Communications LIS not responding after query. 1. Check LIS status.
Error
2. Check for intermittent cable issue.
3. Confirm ACK from Host.
PI150 Self Test Due The time interval since the last Self Run the Self Test on the Maintenance
Test has expired. A Self Test must screen following procedure in manual.
be run before samples can be run.
QC110 QC Result Low QC sample closure time below Review graphical display and determine
defined range limits. acceptability based on laboratory
procedures.
QC120 QC Result High QC sample closure time above Review graphical display and determine
defined range limits. acceptability based on laboratory
procedures.
QC150 QC Test Due The time interval since the last QC Run the QC Test appropriate Cartridge Lot
Test run has expired. following your laboratory’s established
procedure.
12 SC101 No Test Cartridge in Missing cartridge in position ’A’. Check that cartridge was placed in position
’A’ ’A’. If error continues, contact Service for
assistance.
SC102 No Test Cartridge in Missing cartridge in position ’B’. Check that cartridge was placed in position
’B’ ’B’. If error continues, contact Service for
assistance.
SC201 Invalid Test Code in An invalid test code detected on the Verify correct cartridge type. If error
’A’ cartridge in position ’A’. continues, contact Service for assistance.
SC202 Invalid Test Code in An invalid test code detected on the Verify correct cartridge type. If error
’B’ cartridge in position ’B’. continues, contact Service for assistance.
Table 12-2 Other error messages (Continued)

12 Troubleshooting

code
SH100 Processing Error A processing error occurred that 1. Review error log on Help screen.
prevented cartridge testing.
2. Reset Instrument.
3. Repeat test.
4. If error continues, contact Service for
assistance.
SL100 No LIS Test Order LIS does not have test order for Check that the sample ID was entered
sample. correctly.
SS230 Invalid Channel Cartridge can only be run in 1. Consult the reagent instructions for more
Channel A and is not valid in information.
Channel B.
2. Discard cartridge and repeat test using a
new cartridge.
ST300 Trigger System Fail Air in Line detected while Check trigger solution volume and replace
dispensing trigger solution. if needed. If full, contact Service for
assistance.
SU200 Test Cancelled User cancelled the test run during Discard cartridge and repeat test using a
its operation. new cartridge.
TC200 Type Code Read One or more errors occurred while Contact Service for assistance.
Fail trying to read cartridge type code.
TC500 Type Code Sensor Type Code sensor needs Contact Service for assistance.
Fail calibration.
TS100 Bottle Not Present Trigger solution bottle not detected. Verify that bottle is loaded. If error
TS101 Bottle Present Trigger solution bottle detected Verify that bottle is removed. If error
during pump Purge operation. continues, contact Service for assistance.
TS150 Trigger Solution The time interval since the last Run the Trigger Solution Prime operation
Prime Due Trigger Solution Prime has expired. on the Maintenance screen following
A Prime operation should be procedure in manual.
performed to assure proper
instrument operation.
TS200 Trigger System Fail Pump fault detected while Contact Service for assistance.
TS210 Air In Line (AIL)

dispensing trigger solution.
Air in Line detected while Check trigger solution volume and replace
12
dispensing trigger solution. if needed. Perform Prime operation. If
error continues, contact Service for
assistance.
TS220 Air In Line (AIL) Air in Line detected while priming Check trigger solution volume and replace
Trigger Solution. if needed. Repeat Prime operation. If error
TS221 No Air In Line (AIL) Air in Line not detected while Repeat Purge operation. If error
Detected purging Trigger Solution. continues, contact Service for assistance.

12 Troubleshooting

code
TS230 Bottle Was Trigger Solution bottle removed. Verify that bottle is present and perform
Removed Priming is required. Prime operation before using instrument
for testing.
TS240 Trigger System Fail User observation was Trigger Contact Service for assistance.
Solution not dispensed in center of
cartridge.
TS500 Trigger System Fail Air In Line sensor needs calibration. Contact Service for assistance.
TS501 Trigger System Fail Trigger Solution solenoid pump Contact Service for assistance.
needs calibration.
VL100 Vacuum Test Fail One or more errors occurred while Contact Service for assistance.
trying to seal vacuum system.
VL150 Leak Test Needed A Vacuum System Leak Test is Run the Vacuum System Leak Test or a
needed after an O-ring has been Self Test on the Maintenance screen
removed and installed. following procedure in manual.
VL151 O-ring Replacement The time interval since the last O- Replace the O-Ring via the Maintenance
Due ring replacement has expired. The screen following procedure in manual.
O-ring should be replaced to assure
proper instrument operation.
VL200 Vacuum Test Fail Vacuum leak detected. Clean and/or replace O-Ring. If error
VO100 O-Ring Dirty O-Ring needs cleaning. Clean and/or replace O-Ring following
procedure in manual.
VO200 O-Ring Missing O-Ring was removed and not Replace the O ring and conduct a system
replaced. self-test.
VP300 Vacuum Sensor Fail Vacuum sensor not responding. Contact Service for assistance.
VP500 Vacuum Sensor Fail Vacuum sensor needs calibration. Contact Service for assistance.
12

13 Appendix
13 Appendix
This chapter describes the principle of operation of the system, lists the
evaluation formulae used, and the technical specifications.
13.1 Principle of operation
Principle of platelet function The INNOVANCE PFA-200 system is an analyzer and test cartridge system
analysis in which the process of platelet adhesion and aggregation following a
vascular injury is simulated in vitro. Platelet dysfunction detected by the
system may be acquired, inherited, or induced by platelet inhibiting agents.
System functional operation The system allows for rapid evaluation of platelet function on small samples
of anti-coagulated whole blood based on work by Kratzer and Born1. The
single use test cartridge consists of a number of integrated parts including
a capillary, a sample reservoir and a biochemically active membrane with a
central aperture, see Figure 13-1. Anti-coagulated whole blood is aspirated
from the sample reservoir through the capillary and the aperture, so that
platelets are exposed to high shear flow conditions.
At the beginning of a test, trigger solution is dispensed to wet the membrane

and to dissolve the active reagents. During the test, platelets adhere to the
coated membrane. Then, similar to aggregometry2, platelets become
activated and release their granule contents. The release of granule
contents is followed by adherence of platelets to each other to form
aggregates. As a measure of platelet function, the process of platelet
aggregation builds a platelet thrombus at the aperture, thereby gradually
diminishing and finally arresting the blood flow2. The system determines the
time from the start of the test until the platelet plug occludes the aperture,
and reports that time interval as the closure time (CT). The CT is an
indicator of platelet function in the analyzed whole blood sample.
13
1
Kratzer, MAA: Born, GVR: Simulation of Primary Hemostasis in Vitro. Haemostasis
(1985) 5, 357-362.
2
Born, GVR: Aggregation of blood platelets by adenosine diphosphate and its
reversal. Nature 194:927, 1962.

13 Appendix
Detailed descriptions of the test cartridges, their handling, applications and

performance are provided in the instructions for use.
4
7
6
5
1 Trigger solution
2 Pressure transducer
3 Microprocessor
4 Syringe
5 Test cartridge, capillary
6 Test cartridge, sample reservoir
7 Test cartridge, membrane
Figure 13-1 Schematic view of system components and test cartridge
13

13 Appendix
13.2 Calculation of results
13.2.1 Mean and coefficient of variation (CV%) for the display of duplicate test results
For the display of duplicate test results, the mean and CV% are calculated
as follows:
CT ( A ) + CT ( B )
Mean = -----------------------------------------
2
CT ( A ) – CT ( B )
CV% = ----------------------------------------- ⋅ 100%
CT ( A ) + CT ( B )
with:
CT(A) … Closure time of the sample in position A
CT(B) … Closure time of the sample in position B
13.2.2 Mean, coefficient of variation (CV%) and standard deviation in QC charts
For the display in QC charts, the mean, CV% and the standard deviation are
calculated for each cartridge lot as follows:
∑ CT ( i )
i=1
Mean = CT = -----------------------
n
n
1
∑ [ CT ( i ) – CT ]
2
Standard deviation = s = ------------ ⋅
n–1
i=1
s
CV% = -------- ⋅ 100%
CT
with:
n … Number of measured QC samples

13
CT(i) … Closure time of the i-th QC sample

13 Appendix
13.3 Technical specifications
Physical
Dimensions (L x W x H) 37.3cm x 25.6cm x 37.4cm

(14.7" x 10.1" x 14.7")
Required space for ventilation 5cm on all sides
Recommended workspace (L x W x H)50cm x 35cm x 60cm
Weight 10kg (22lbs.)
Required load capacity of worktop 50kg
Electrical
Operating voltage, frequency 100 to 240VAC, 50/60Hz

Current 1.38A @ 90VAC
Power consumption 124W
Fuse 2.0A/250V Slo-Blo, Littelfuse*, 5 x 20mm
Environmental
Operating temperature 18 to 29°C

Non-operating storage and -29 to 50°C
transportation temperature
Operating humidity 20 to 90%RH, non-condensing
Non-operating storage and 0 to 95%RH, non-condensing
transportation humidity
Pollution degree 2
Degree of protection IP20
(according to IEC 60529)
Altitude (maximum) 2000m
General
Installation category ΙΙ
Incubation well temperature 37.9°C ± 1°C
Incubation well warm-up time Maximum 15min
(room to operating temperature)
Incubation time 3.0min
13 Cassette capacity 2 test cartridges
Maximum sample volume 1000µL
Vacuum set point 40mBar
Sound pressure level 1 47dB(A)
1
During sound pressure level measurement, the system was operated as in normal
use with all accessories connected. The sound pressure level was measured from
a distance of 1m from the surface of the system and a height of 1.6m from the floor
or access platform. The measurement was performed using an A-weighted sound
pressure level meter. The ambient noise was measured as 42dB(A).

13 Appendix
Printer
Type 24 character wide thermal line

Paper 61.9mm wide, standard 5 year readable life
External I/O ports
RS-232 LIS/Manufacturer tester

Ethernet LAN
USB (3ea) Software update, printer, barcode scanner
Software
Patient ID Maximum 20 characters

Stored results: Last 1200 patient and/or QC results
Stored errors: Last 1200
Stored maintenance events: Last 1200
13

13 Appendix
13

Index
Index carousel 4-1, 4-2

exercise 12-6
reset 12-6
cartridge cassette 4-1

A
cartridge lot 8-7
access levels 5-7
cartridge type 5-3
accessory kit 3-2
cartridge type code, read 12-8
add
cassette 4-1, 4-2, 4-5
maintenance event 11-13
user account 6-1 caution, safety message 2-4
administrator, user group 5-7 CE conformity 2-7
alarm volume 6-7 clean o-ring

in the analyzer 11-4
alphanumeric keyboard 5-5
manually 11-6
alt key 5-5
cleaning pad 4-6
analyzer 4-1
clear test 5-3, 8-5
analyzer box, content 3-1
closure time 5-3, 13-1
arrow keys
configuration settings, print 6-8
in lists 5-7
in the menu bar 5-6 consumables 4-5
assignment of sample IDs 6-6 CV% 5-3, 13-3
B D
backspace key 5-5, 5-6 daily maintenance 11-1
barcode scanner 4-4 danger, safety message 2-4
biological risks 2-5 date and date format, set 6-3
black pads for cartridge type recognition 4-2 date and time, display 5-1
delete user account 6-2
C delivery 3-1
disable sound 6-7

cancel test 8-6
display
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0 IX 1

Index
error 12-1 G
maintenance history 11-12
QC chart 8-11 gloves 2-3
results 5-4
disposal H
system 3-4
test cartridges, consumables, liquid waste 2-3 H flag 6-4, 6-5
documentation CD kit 3-1 help 12-1
duplicate test 8-1 hematocrit 12-12, 12-13
history, maintenance 11-12
E
I
electrical safety 2-2
electromagnetic compatibility 2-7 icon

maintenance 11-1
electromagnetic environment 2-2
print spooling 5-2
enter key 5-5, 5-6
USB 5-2
error
incubation system, test 12-7
display 12-1
incubation time, display 5-3
print 12-3
incubation wells 4-2
error sound
set 6-7 infectious material 2-3
turn off 12-3
Initial sample flow obstruction, error 12-11
ethernet port 4-4
installation 3-2
event, maintenance 11-12
intended use 2-1
exit key 5-5, 5-6
external devices 4-4

K
key volume 6-7

F
keyboard
flags (H, L) 6-4, 6-5 alphanumeric 5-5
numeric 5-6
fuse compartment 4-4
fuses, install 12-8
IX 2 INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

Index
L maximum syringe travel, error 12-13
maximum test time, error 12-14

L flag 6-4, 6-5
mean 5-3, 13-3
laboratory information system 4-4
measure
language, set 6-1
patient samples 8-1
LCD screen, test 12-7 QC samples 8-7
LIS mechanical safety 2-3

connect 4-4
menu bar 5-1, 5-2
retransmit results 8-8
set type 6-8 menu Run 5-3
load monitor temperature 12-7
printer paper 11-8

samples 8-4
N
trigger solution 11-2
load capacity, worktop 13-4 network 4-5
log off 9-1 non-operation 3-4
log on 7-1 notice, safety message 2-4
logoff, access level 5-7 numeric keyboard 5-6
M O
maintenance event obligations, system owner 2-7
add 11-13 operational safety 2-2

print 11-13
operator qualification 2-1
maintenance history, display 11-12
ordering information 1-3
maintenance reminder 11-1
orientation tips 1-1
maintenance, periodic 11-1
o-ring 4-5
manage user accounts 6-1 clean in the analyzer 11-4
match clean manually and inspect 11-6
error 12-1 install 11-6
maintenance event 11-12 remove 11-5
QC lot number 8-11 o-ring service tool 4-5

test result 8-8

Index
overview, software 5-1 preset passwords 3-3
prime 11-3
P priming cartridge 4-5
principle of operation 13-1

password
change 6-2 print
preset 3-3 configuration settings 6-8
set 6-2 maintenance event 11-13

results of self tests 6-8
patient ID
test results 8-5
duplicate test or two test types, same sample
ID 8-2 print spooling icon 5-2
single test 8-1
printer 4-1, 4-3
two tests, different sample ID 8-3
test 12-8
patient information 5-3
printer options 6-7
patient samples
printer paper 4-1, 4-6
measure 8-1
advance 11-12
set reference range 6-5
load 11-8
PDF files of results 8-8
purge 11-3
periodic maintenance 11-1
platelet dysfunction
Q
excess of maximum time 12-14
insufficient sample 12-12
QC chart
maximum syringe travel 12-13
display 8-11
principle of analysis 13-1
zoom in 8-12
ports 4-4
QC interval 6-4
ethernet 4-4
QC samples 2-4
RS-232 4-4
measure 8-7
USB 4-1, 4-4
set reference range 6-4
power
quality control (QC) 2-4
outlet 3-2
socket 4-4
switch 4-4
R
precision and accuracy of test results 2-3
radio interference 2-2
prepare test cartridges 7-1

Index
reference range sample flow obstruction when processing the sample,

error 12-11
flag 5-3
patient samples 12-12 sample ID 5-3
set for patient samples 6-5
sample ID entry method, set 6-6
set for QC samples 6-4
sample information
reminder
duplicate test or two test types, same sample
maintenance 11-1 ID 8-2
QC 6-4 single test 8-1
two tests, different sample ID 8-3
remove
o-ring 11-5 sample type 5-3
samples 8-6
scope of delivery 3-1
reprint results 8-8
screen saver 4-3
reset system 12-3
scrolling arrows 5-1, 5-2
results 5-3 in lists 5-7
create PDF files 8-8 in the menu bar 5-6
print 8-5
search
reprint 8-8
error 12-1
retransmit to LIS 8-8
maintenance event 11-12
transmit to LIS 8-5
QC chart 8-11
rights, user group 5-7 test result 8-8
RS-232 port 4-4 sedimentation rate 12-12, 12-13
run test 8-5 self test 7-2

print results 6-8
Run, menu 5-3
service 1-2
Service and Siemens, user groups 5-7

S
shift key 5-5
safe handling
shut down, system 9-1
analyzer 2-2
samples, reagents and consumables 2-3 signal words 2-4
safety information 2-1 software

functions 5-1, 5-2
safety messages 2-4
overview 5-1
sample air leak, error 12-10 update 5-7
sample depleted, error 12-12 sound 6-7, 12-3

Index
space key 5-5 start and clear 8-5
special keys 5-5, 5-6 test cartridges, prepare 7-1
standard deviation 13-3 test phases 5-3
standards, international 2-7 test time 5-3
start thermoprinter 4-3

system 7-1
time and time format, set 6-3
test 5-3, 8-5
tone 6-7
status bar 5-1, 5-2
touch screen 4-1, 4-3
status messages 5-1, 5-2
clean and disinfect 10-1
status symbol 5-1, 5-2
trailing lines 6-7
statutory requirements 2-7
trigger solution compartment 4-1, 4-3
stop test 5-3
trigger solution dispensing, check 7-2, 12-3
structure of safety messages 2-5
trigger solution pump, exercise 12-4
stylus 4-6
trigger solution, load 11-2
sunlight 3-2
type code, read 12-8
symbols
on consumables 2-6
on the analyzer 2-5
U
syringe 13-2 unpacking 3-1

exercise 12-5
update, software 5-7
reset 12-5
USB flash drive 4-5, 4-6
system check 7-2
USB icon 5-2
system functions 2-1
USB port 4-1, 4-4
system owner, obligations 2-7
user account
add 6-1
T delete 6-2
edit 6-2
target paper 4-6
user groups and user rights 5-7
temperature, monitor 12-7
test 5-3
cancel 8-6

Index
vacuum chuck
exercise 12-6
reset 12-5
vacuum cup 4-5
vacuum leak, test 11-7
vibrations 3-2
viscosity 12-12, 12-13
volume
error 6-7
key 6-7
warning, safety message 2-4
warranty 1-2
waste electrical and electronic equipment 2-5, 3-4
wear and tear parts 1-2
weekly maintenance 11-1
well, for o-ring cleaning pad 4-2
workspace 13-4
yearly maintenance 11-1
zoom in on QC chart 8-12

Index

If you obtain an addendum to the instruction manual, file it after this page.
INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0 ADD 1

ADD 2 INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

Innovance Pfa 200 Im 10 en

Uploaded by

Copyright:

Available Formats

Innovance Pfa 200 Im 10 en

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Innovance Pfa 200 Im 10 en

Uploaded by

Copyright:

Available Formats

INNOVANCE® PFA-200*

– Instructions for Use –

Manual Version: 1.0

© 2010 Siemens Healthcare Diagnostics Products GmbH. All rights reserved.

Manual, Order Number: 1 000 1674.0610

Trademarks Dade, INNOVANCE and PFA-200 are trademarks of Siemens Healthcare

Software Copyrights Software of Siemens Healthcare Diagnostics Products GmbH is the

Disclaimer Siemens Healthcare Diagnostics has validated the provided instructions,

Siemens Healthcare Diagnostics Products GmbH

3 Life cycle of the system

4 Description of the hardware

5 Description of the software

6 Configuring the system

7 Preparing for the analysis

8 Performing the analysis

9 Finishing the analysis

10 Cleaning and disinfecting the system

Addendum to the instruction manual

INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

1.1 Orientation tips 1-1

1.2 Service 1-2

1.3 Warranty 1-2

1.4 Ordering information 1-3

2 Safe handling 2-1

2.1 Intended use 2-1

2.2 Operator qualification 2-1

2.3 General safety information 2-1

2.4 Quality control (QC) 2-4

2.5 Safety messages 2-4

2.6 Symbols 2-5

2.7 Statutory requirements 2-7

2.8 Obligations of the system owner 2-7

3 Life cycle of the system 3-1

3.1 Delivery 3-1

INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0 TOC 1

3.2 Installation 3-2

3.3 Non-operation 3-4

3.4 Disposal 3-4

4 Description of the hardware 4-1

4.1 Analyzer 4-1

4.2 Connection of external devices 4-4

4.3 Consumables and accessories 4-5

4.4 Test cartridges and trigger solution 4-6

5 Description of the software 5-1

5.1 Overview 5-1

5.2 Display in the menu Run 5-3

5.3 Display of results 5-4

5.4 Keyboards 5-4

TOC 2 INNOVANCE® PFA-200* System – Instruction Manual – Version 1.0

5.5 Arrow keys 5-6

5.6 User rights 5-7

5.7 Software updates 5-7

6 Configuring the system 6-1

6.1 Setting the language 6-1

6.2 Managing user accounts (administrators only) 6-1

6.7 Setting the sample ID entry method (administrators only) 6-6

6.8 Setting sounds 6-7

6.9 Setting printer options (administrators only) 6-7