Siemens PFA-100 System User manual

PFA-100 System
Instruction Manual (US)
– Instructions for Use –
11210658
Manual Version: 1.0.1
Date of Issue: 2017-12
We reserve the right to make changes in the course of technical development without previous notice.
© 2016 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.

Updating 1.
Trademarks PFA-100 and Dade are trademarks of Siemens Healthcare Diagnostics Inc.
Mikrozid is a trademark of Schülke & Mayr GmbH.
Littelfuse is a trademark of Littelfuse Inc.
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.
Version Date Changes
Manual Software
1.0 2.20 2016-11 First version
1.0.1 2.20 2017-12 Update
Siemens Healthcare Diagnostics Products GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany
www.siemens.com/diagnostics

Chapter overview
PFA-100 System – Instruction Manual (US) – Version 1.0.1
Chapter overview
1 About this document
2 Safe handling
3 Delivery and installation
4 Quick reference guide
5 Service and warranty
6 Description of the analyzer
7 Setup and changing configuration
8 Performing tests
9 QC procedures
10 Cleaning and disinfection
11 Maintenance
12 Diagnostics and troubleshooting
Index

PFA-100 System – Instruction Manual (US) – Version 1.0.1
Chapter overview

Table of contents
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Table of contents
1 About this document 1-1
1.1 Orientation tips 1-1
1.2 Abbreviations 1-2
2 Safe handling 2-1
2.1 Intended use 2-1
2.2 General safety information 2-2
2.2.1 Operator qualification 2-2
2.2.2 Electrical safety 2-2
2.2.3 Mechanical safety 2-3
2.2.4 Operational safety 2-4
2.2.5 Safe handling of samples, PFA test cartridges, and consumables 2-5
2.2.6 Correct functionality of the analyzer 2-6
2.3 Safety messages 2-6
2.3.1 Signal words in safety messages 2-6
2.3.2 Structure of safety messages 2-6
2.4 Meaning of the warning and information symbols on the analyzer 2-7
2.5 Statutory requirements 2-7
2.6 Obligations of the system owner 2-7
3 Delivery and installation 3-1
3.1 Delivery 3-1
3.1.1 Transporting the analyzer 3-1
3.1.2 Scope of delivery 3-1
3.1.2.1 Accepting delivery 3-2
3.1.2.2 Unpacking 3-2
3.1.2.3 Inventory analyzer accessories 3-4

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Table of contents
3.2 Installation 3-7
3.2.1 Operating conditions 3-8
3.2.1.1 Ambient conditions for storage 3-8
3.2.1.2 Ambient conditions for operation 3-8
3.2.2 Requirements of worktop 3-9
3.2.3 Connecting the analyzer 3-10
3.2.3.1 Installing fuses 3-11
3.2.3.2 Connecting the analyzer to the power source 3-13
3.2.3.3 Loading printer paper 3-14
3.2.3.4 Threading printer paper 3-16
3.2.3.5 Loading trigger solution 3-17
3.2.3.6 Checking for correct installation 3-19
3.3 Preparing the analyzer for longer periods of non-operation 3-20
4 Quick reference guide 4-1
5 Service and warranty 5-1
5.1 Siemens service 5-1
5.2 Warranty 5-1
5.3 Ordering information 5-2
5.4 Disposal of the analyzer 5-3
6 Description of the analyzer 6-1
6.1 Analyzer 6-1
6.1.1 Carousel 6-2
6.1.2 Trigger solution compartment 6-3
6.1.3 LCD display 6-3
6.1.4 Keyboard 6-4
6.1.5 Printer 6-4
6.2 Consumables 6-5
6.2.1 Consumables’ labels 6-5
6.2.2 Consumables/parts list 6-6
6.2.3 PFA test cartridges 6-7

Table of contents
PFA-100 System – Instruction Manual (US) – Version 1.0.1 3TOC
6.3 Technical specifications 6-7
6.3.1 Physical 6-7
6.3.2 Electrical 6-7
6.3.3 Environmental 6-8
6.3.4 General 6-8
6.3.5 Printer 6-9
6.3.6 Software 6-9
6.4 Data connections 6-9
6.5 Laboratory information system (LIS) 6-11
6.6 Principle of operation 6-12
7 Setup and changing configuration 7-1
7.1 Priming the analyzer 7-1
7.2 Setup of the software 7-3
7.2.1 Selecting language 7-3
7.2.2 Setting the time format 7-4
7.2.3 Setting the date format 7-6
7.2.4 Patient identification request 7-7
7.2.5 Analyzer initialization 7-8
7.3 Configuration 7-8
7.3.1 Low/high flag ranges 7-9
7.3.2 Audible keys 7-11
7.3.3 Laboratory information system (LIS) 7-12
8 Performing tests 8-1
8.1 Test request with patient ID number option disabled 8-4
8.1.1 Single test 8-4
8.1.2 Duplicate test or two test types, same patient ID 8-4
8.1.3 Two different test types, different patient ID 8-5
8.2 Test request with patient ID number option enabled 8-6
8.2.1 Single test 8-6
8.2.2 Duplicate test or two test types, same patient ID 8-7
8.2.3 Two test types, different patient ID 8-8

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Table of contents
8.3 Canceling tests 8-9
8.4 Printing results 8-10
8.4.1 Automatic printing after test 8-10
8.4.2 Printing the results of the last run 8-10
8.4.3 Printing stored test results 8-11
8.4.4 Printing usage history 8-12
9 QC procedures 9-1
9.1 Self test and daily alignment check for trigger solution dispensing 9-2
9.2 Run control 9-6
9.3 Printing control results 9-9
10 Cleaning and disinfection 10-1
10.1 Cleaning the analyzer 10-1
10.2 Disinfecting the analyzer 10-1
11 Maintenance 11-1
11.1 Replacing trigger solution 11-2
11.2 Priming the system 11-4
11.3 O-Ring maintenance 11-6
11.3.1 Maintaining and inspecting the O-Ring 11-6
11.3.2 Removing the O-Ring 11-7
11.3.3 Installing the O-Ring 11-9
11.3.4 Cleaning O-Ring using cleaning pads 11-10
11.4 Replacing printer paper 11-13
11.5 Replacing printer ribbon 11-15
11.6 Replacing fuses 11-16

Table of contents
PFA-100 System – Instruction Manual (US) – Version 1.0.1 5TOC
12 Diagnostics and troubleshooting 12-1
12.1 Power on diagnostics 12-1
12.2 Self test 12-1
12.3 Printing error log 12-2
12.4 Displaying test results 12-3
12.5 Common status messages 12-5
12.5.1 Maximum Test Time Exceeded 12-6
12.5.2 Test Terminated Due To Air Leak 12-7
12.5.3 Test Terminated Due To Flow Obstruction 12-8
12.5.4 Test Terminated Due To Insufficient Sample 12-9
12.5.5 Test Terminated Due To Maximum Syringe Travel 12-10
12.6 Other status messages 12-11
Index IX-1

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Table of contents

1 About this document
PFA-100 System – Instruction Manual (US) – Version 1.0.1 11
1
1 About this document
This chapter contains information about:
•Orientation tips (Chapter 1.1)
•Meaning of the symbols and abbreviations used (Chapter 1.2)
1.1 Orientation tips
The following conventions are used to make the manual easier to handle.
Page numbering The page number consists of:
Bullets Bullets indicate a list.
Example:
The box contains:
•Monitor
•Keyboard
•Manual
Numbers Numbers indicate a procedure.
Example:
1. Open the box.
2. Check the content.
3. Read the manual.
The numbering is also used if the procedure includes only 1 step.
Arrow An arrow indicates 1 or more results of an action.
Example:
1. Select Print.
 The dialog Print is displayed.
1st number (in green box): Chapter
2nd number (to the right of the box): Page of chapter
Example:
13 = page 3 of chapter 1

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1 About this document
1
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.
Gray note Gray notes indicate important background information.
Example:
1.2 Abbreviations
The following abbreviations are used in the manual:
Note: Once the process has been started, it cannot be interrupted.
Abbreviations Meaning
ADP Adenosine-5’-diphosphate
COL Collagen
CT Closure Time
EMC Electromagnetic compatibility
EPI Epinephrine
GS Geprüfte Sicherheit (safety-tested)
ID Identification
PFA PFA-100 System
Table 1-1 Abbreviations
Note: For information on software upgrades contact Siemens service.

2 Safe handling
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2 Safe handling
This chapter contains information about:
•The intended use (Chapter 2.1)
•General safety information (Chapter 2.2)
•The meaning of the warning and information symbols on the analyzer
(Chapter 2.4).
•The statutory requirements (Chapter 2.5)
•The obligations of the system owner (Chapter 2.6).
2.1 Intended use
The PFA-100 Platelet Function Analyzer and Dade PFA-100 Reagents are
in vitro diagnostic devices intended to aid in the detection of platelet
dysfunction in citrated human whole blood.
The PFA-100®System is an instrument 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 PFA-100 System
may be acquired, inherited, or induced by platelet inhibiting agents.
The PFA-100 System is for in-vitro diagnostics only.
The instrument’s functions are:
•Moving the carousel (containing PFA test cartridges with samples) into
the instrument
•Reading the test code
•Dispensing the trigger solution into each PFA test cartridge
•Incubating the samples
•Aspirating the sample through the aperture of the PFA test cartridge
•Measuring the blood flow rate through aperture at a constant vacuum
•Determining the closure time by detecting a flow rate, which is for three
seconds below 10% of the initial flow rate at the beginning of the test
•Calculating and analyzing the readings
•Printing the readings
One or two PFA test cartridges containing samples can be placed in the
instrument after:
•Loading the required PFA test cartridges
•Entering the test
 Then the samples are processed fully automatically as far as the
analysis stage.

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2 Safe handling
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2.2 General safety information
The system has been inspected for technical safety before distribution. To
maintain this status and to ensure hazard-free operation:
•Always follow the instructions in this manual.
•If you obtain an addendum, read the addendum. The information in the
addendum reflects the current status and supersedes other information
in the corresponding manual, if applicable.
•Only use the system as intended. If the system is not used as intended,
Siemens disclaims all liability for any personal injury and property
damage.
•Only perform maintenance as described in this manual. If maintenance
is not performed as described or if other maintenance is performed,
Siemens disclaims all liability for any personal injury and property
damage.
•Always follow good laboratory practice.
•Make sure the operating and storage conditions are met, see
Chapter 3.2.1 and Chapter 6.3.
2.2.1 Operator qualification
Risk of death and serious injury due to lack of knowledge. To avoid this
hazard:
•The system must be operated only by persons whose skills, knowledge,
and practical experience qualify them to do so, and who have read and
understood this manual.
•Instruction in operating the PFA-100 System is given when the analyzer
is installed by Siemens. If you have any further training requirements,
contact your local Siemens office.
2.2.2 Electrical safety
Risk of electric shock when contacting live parts. Even when the system is
switched off, some components, for example, capacitors, can be live as
they can still be electrically charged. Death or serious injury can result. To
avoid this hazard:
•Check that the voltage is set correctly before connecting the analyzer to
the mains supply.
•Connect the system only to a socket with a ground contact (earth).
•Only use double insulated extension cables with a protective conductor
and ground contact.
•Never disconnect the ground contacts from the line.
•Never interrupt the protective conductor inside or outside the system.
•Never remove protective guards or fused components.

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•Ensure that all surfaces, including the floor, are dry when using the
system.
•Make sure that the main power switch of the system is easily accessible.
•If the analyzer needs to be opened for calibration, maintenance, repair,
or replacement (e.g., of fuses), switch off the analyzer and disconnect it
from all voltage sources as described in the relevant procedure. If any
calibration, maintenance or repair work has to be carried out on the open
analyzer while it is connected to a mains power source, this may only be
performed by a specialist who is familiar with the dangers associated
with such action.
•Only use replacement fuses of the specified type and current rating.
•Only use fuses in perfect technical order.
•Never short-circuit the fuse holder.
Risk of short-circuit by spilled liquids that can come into contact with live
parts. Damage to the system can result. To avoid this hazard:
•Never pour liquids or place containers with liquid on top of the system.
•Disconnect the main plug immediately if liquid is spilled into the system.
Risk of malfunctions in nearby electrical devices due to radio interference.
In a domestic environment, it can cause radio interference. To avoid this
hazard:
•Assess the electromagnetic environment prior to operating the analyzer.
•Use the cables supplied.
•Use shielded cables and plugs if external devices are connected, for
example, a printer or a network.
Risk of malfunctions of the system such as false results due to radio
interference by other electrical devices. To avoid this hazard:
•Do not operate strong electromagnetic transmitters, for example, mobile
phones, walkie-talkies, door openers, or elevators, in the vicinity of the
system.
•In places where the quality of the power supply line is poor or impacted
by other electrical devices, consider the use of an external UPS.
2.2.3 Mechanical safety
Risk of injury by moving parts. To avoid this hazard:
•Do not touch the carousel while the measurement is in progress.
•Never bypass or remove safety devices, for example, cover switches.
•Never open or remove the cover whilst the analyzer is in operation. The
cover may only be opened by Siemens service.
•Keep clear of moving parts when the system is in operation. Long hair,
necklaces, bracelets, and similar objects can get caught in moving parts.

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Risk of damage to the spiking needle of the trigger solution bottle. To avoid
this hazard:
•Make sure that the access door for the trigger bottle is fully closed before
pushing the lever down.
Risk of injury by the spiking needle of the trigger solution bottle. To avoid
this hazard:
•Lift up the lever of the spiking needle completely before opening the
access door.
•Take care not to touch the spiking needle when changing the trigger
solution bottle.
2.2.4 Operational safety
Risk of burns by combustion of flammable liquids. Death or serious injury
can result. To avoid this hazard:
•Keep flammable liquids away from heat or open flame.
•Place the system in a well-ventilated area.
If a flammable liquid has been spilled, immediately take the following
measures to prevent combustion:
•Eliminate all sources of ignition.
•Remove flammable liquid with a non-combustible absorbent material.
•Vent the room.
Risk of explosion due to ignition caused by sparks generated by the
system’s switch contacts. Death or serious injury can result. To avoid this
hazard:
•Never operate the system in an environment containing explosive
mixtures of oxygen, hydrogen, or other flammable gases.
Risk of property damage due to incorrect handling of the system. Rough
handling or dropping can disturb or damage internal components. Improper
interventions on the system void the warranty and can result in service work
having to be charged for. To avoid this hazard:
•Always handle the system with care.
•Switch off the system and secure it against accidental operation if there
is visible damage to the system or if you have any other reason to
believe that safe operation is no longer possible. This may be assumed:
–If the analyzer is no longer working after a technical malfunction
–After an extended period of storage
–After being transported in harsh conditions
•Only carry out maintenance or replace parts as described in this manual.
•Only use Siemens spare parts.
•Do not use solvents or abrasive cloths to clean the system.

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2.2.5 Safe handling of samples, PFA test cartridges, and consumables
Risk of infection by potentially infectious material. Samples/blood, used
PFA test cartridges and parts of the system which have come into contact
with this material are potentially infectious. Death or serious injury can
result. To avoid this hazard:
•Wear appropriate personal protective equipment, that is, gloves,
protective clothing, safety glasses, and mask, according to national and
local standards and regulations.
•Handle potentially infectious material in accordance with good
laboratory practice, for example, as described in CLSI documents
available at www.clsi.org.
•Only open covers as described in this manual.
•Avoid contact of the skin and mucosa with potentially infectious material.
•See the instructions for use of the PFA test cartridges as well as the
application sheets.
•Check with local waste disposal authorities for specific requirements
regarding potentially infectious material.
•Discard potentially infectious material according to national and local
standards and regulations.
Risk of false results. False results can lead to misdiagnosis and incorrect
treatment. To avoid this hazard:
•Only use approved Siemens consumables.
•Monitor the stability of the PFA test cartridges and trigger solution, see
the instructions for use.
Risk of irritation of the skin and mucous membranes by liquids for cleaning
and purging. Minor or moderate injury can result. To avoid this hazard:
•Wear appropriate personal protective equipment, that is, gloves,
protective clothing, safety glasses, and mask, according to national and
local standards and regulations.
•Pay attention to the manufacturer’s information regarding the gloves’
compatibility with the materials and liquids used.
•Follow all product manufacturer’s instructions.
Risk of property damage due to incorrect handling of samples, PFA test
cartridges, and consumables. To avoid this hazard:
•Only use approved Siemens consumables.
•See the instructions for use that are supplied with the PFA test
cartridges and consumables.
Risk of pollution by incorrect waste disposal. Damage to the environment
can result. To avoid this hazard:
•Discard waste material according to national and local standards and
regulations.

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2.2.6 Correct functionality of the analyzer
Risk of false results or delayed results due to incorrect functioning of the
analyzer. False results can lead to misdiagnosis and incorrect treatment. To
avoid this hazard:
•Check that the analyzer is functioning correctly.
•Check the functionality of the analyzer daily with the software’s Self Test
function.
2.3 Safety messages
All safety messages must be observed to avoid hazardous situations which
can result in death, injury, or damage to the equipment.
2.3.1 Signal words in safety messages
The following explains the signal words and their meanings.
2.3.2 Structure of safety messages
The following explains the structure of safety messages.
Signal word Meaning
Indicates a hazardous situation which, if not avoided, will result in death
or serious injury
Indicates a hazardous situation which, if not avoided, could result in
death or serious injury
Indicates a hazardous situation which, if not avoided, may result in minor
or moderate injury
Indicates a property damage message
Table 1 Signal words
DANGER
WARNING
CAUTION
NOTICE
WARNING
This section states nature and source of the hazard
This section states potential consequences of not avoiding the hazard. This
section can be combined with the previous section.
•This section lists preventive actions to avoid the hazard.

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2.4 Meaning of the warning and information symbols on the analyzer
2.5 Statutory requirements
International standards The analyzer complies with the following directives:
•73/23/EEC Low-Voltage Directive
•89/336/EEC EMC Directive
The PFA-100 System has been designed and tested to comply with safety
standards EN 61010 and IEC 61010 under the conditions listed in
Chapter 6.3.
Electromagnetic compatibility
(EMC)
The basis for the test is EN 61326 or IEC 61326. The analyzer has been
developed and tested according to EN 61326-1 class A.
2.6 Obligations of the system owner
The system owner takes on the obligations arising from the national
legislation about the operation of in vitro diagnostic medical devices.
General warning which draws the user’s attention to particular potential
hazards.
This label certifies that the analyzer has been tested according to Canadian
and US safety standards by the nationally recognized testing laboratory TÜV.
Biohazard
The marked area of the analyzer can come into contact with potentially
infectious material.
The safety instructions for working with infectious material must be followed.
Table 2-1 Warning and information symbols

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