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Siemens Healthcare PFA-100 Instruction Manual

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PFA‑100 System
 
Instruction Manual – US only
2024-12
siemens-healthineers.com

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  • Page 1 PFA‑100 System   Instruction Manual – US only 2024-12 siemens-healthineers.com...

  • Page 2: Table Of Contents

    Table of contents Introduction About this manual Orientation tips Identification Service Warranty 1.5.1 Limited warranty on wear and tear parts Ordering information Trademarks Manual version history Safe handling Intended use 2.1.1 System functions Intended user Use environment General safety information 2.4.1 Operator qualification 2.4.2...
  • Page 3 Table of contents Configuring the system Priming the analyzer Selecting the language Setting the time format 5.3.1 12‑hour format 5.3.2 24‑hour format Setting the date format Setting the patient identification request Initializing the system 5.6.1 Power on diagnostics Selecting low/high flag ranges Using option Audible Keys Selecting the laboratory information system (LIS) QC procedures...
  • Page 4 Table of contents Common status messages 9.4.1 Maximum test time exceeded 9.4.2 Test terminated due to air leak 9.4.3 Test terminated due to flow obstruction 9.4.4 Test terminated due to insufficient sample 9.4.5 Test terminated due to maximum syringe travel Other status messages Technical specifications 10.1...

  • Page 5: Introduction

    1 Introduction 1 Introduction This chapter gives introductory information. About this manual This manual describes the use of the PFA‑100® System in clinical laboratories. This manual is only valid in conjunction with other user manuals available electronically on the system or in print. Orientation tips Indicates a hint Is used to provide information on how to avoid operating errors or information...

  • Page 6: Service

    1 Introduction Product Order number Dade PFA Vacuum Cups 10445703 B4170‑75 PFA Cassettes 10459383 B4170‑70 PFA Cleaning Pads 10459386 B4170‑73 PFA O‑Ring Service Tool 10459387 B4170‑77 PFA O‑Rings 10459388 B4170‑78 PFA‑100 Printer Paper 10459384 B4170‑71 PFA‑100 Barcode Scanner 11539138 B4170‑6 PFA‑100 Printer Ribbon 10459385 B4170‑72...

  • Page 7: Ordering Information

    1 Introduction • O-rings • Cleaning pads • Printer ribbon • Printer paper The warranty term for these wear and tear parts is included in the service contract. Ordering information Only use original Siemens Healthineers consumables, accessories, and spare parts. Order these only from Siemens Healthineers.

  • Page 8: Safe Handling

    This chapter describes the intended use of the system and gives general safety instructions. 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.

  • Page 9: Use Environment

    2 Safe handling Use environment The system is to be used in professional healthcare facility environment only. 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. •...

  • Page 10: Mechanical Safety

    2 Safe handling • Never interrupt the protective conductor inside or outside the system. • Never remove protective guards or fused components. • Ensure that all surfaces, including the floor, are dry when using and maintaining the system. • Make sure that the power switch is easily accessible. •...

  • Page 11: Operational Safety

    2 Safe handling • Keep clear of moving parts when the system is in operation or maintenance is performed. Long hair, necklaces, bracelets, and similar objects can get caught in moving parts. Risk of injury by the spiking needle of the trigger solution bottle. To avoid this hazard: •...

  • Page 12: Safe Handling Of Samples, Test Cartridges, Trigger Solution, Accessories, And Consumables

    2 Safe handling 2.4.5 Safe handling of samples, test cartridges, trigger solution, accessories, and consumables Risk of infection due to infectious material. Samples, test cartridges, trigger solution, accessories, consumables, and parts of the system which have come into contact with this material are potentially infectious.

  • Page 13: Correct Functionality Of The Analyzer

    2 Safe handling 2.4.6 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. •...
  • Page 14 2 Safe handling Symbol Meaning CE mark Consult instructions for use Contents [CONTENTS] Date of manufacture Do not re-use EAC mark Fuses Handle with care In vitro diagnostic medical device [IVD] Keep dry Manufacturer O-ring service tool O-rings Power off Power on Priming cartridges Printer paper...

  • Page 15: Statutory Requirements

    2 Safe handling Symbol Meaning This way up Store in upright position Trigger solution [PFA_ | TRIGGER] Unique device identification barcode Use-by date Vacuum cups Warning; Biological hazard The labeled area can come into contact with infectious material. The safety instructions for infectious material must be observed, see ( Page 12 Safe handling of samples, test cartridges, trigger solution, accessories, and consumables).

  • Page 16: Life Cycle

    3 Life cycle 3 Life cycle This chapter describes the stages the system goes through, from delivery to disposal, and the requirements involved for the user with each stage. Delivery 3.1.1 Unpacking and checking the delivery To unpack and check the delivery, proceed as follows: 1 Before opening, check the transport box for signs of external damage.
  • Page 17 3 Life cycle 6 Remove the analyzer from the transport box. There are indentations on the analyzer that can be used as handles. 7 Remove the plastic wrapping from the analyzer. 8 Open the accessory kit. The accessory kit contains the items shown in the figures below. US only | Instruction Manual PFA‑100 System | 2024-12 Print No.
  • Page 18 3 Life cycle Accessory kit PFA O-Rings US only | Instruction Manual PFA‑100 System | 2024-12 Print No. DCHS-E00.621.01.01.02...
  • Page 19 3 Life cycle PFA Cassettes Fuses Paper Roll Axle Dade PFA Vacuum Cup US only | Instruction Manual PFA‑100 System | 2024-12 Print No. DCHS-E00.621.01.01.02...
  • Page 20 3 Life cycle PFA Cleaning Pads PFA-100 Printer Ribbon Dade PFA Priming Cartridges PFA-100 Printer Paper US only | Instruction Manual PFA‑100 System | 2024-12 Print No. DCHS-E00.621.01.01.02...

  • Page 21: Scope Of Delivery

    3 Life cycle PFA O-Ring Service Tool 9 Check the content for completeness, see ( Page 21 Scope of delivery), and intact condition. 10 If anything is missing or damaged, inform Siemens Healthineers service immediately. 3.1.2 Scope of delivery The delivery includes: • 1 analyzer •...

  • Page 22: Installation

    3 Life cycle The Dade PFA Trigger Solution (order number:B4170‑50), Test Cartridges (order number Collagen/ADP: B4170-21A, order number Collagen/EPI: B4170-20A) and the power cord (order number: 10452340) are required for operation, but included in the delivery and must be ordered separately. Installation This chapter contains information about the operating conditions and worktop requirements for the installation of the system as well as the steps to be performed...

  • Page 23: Requirements Of Worktop

    3 Life cycle 3.2.2 Requirements of worktop The small size of the system requires an area on the laboratory bench top which is approximately 30 cm wide and 50 cm deep, with about 50 cm clearance above the bench. The worktop for the analyzer must meet the following requirements: •...
  • Page 24 3 Life cycle NOTICE Setting the voltage incorrectly can result in damage to the analyzer. Damage to the system can result. ◆ Do not connect the analyzer to the power supply until the correct operating voltage has been set. ◆ Connect the analyzer to the power supply using one distribution box. Installing fuses WARNING Electric shock by contact with live parts...
  • Page 25 3 Life cycle 1 Pry open the fuse compartment with a small screw driver and remove the fuse holder from the analyzer, see figures below. Fuse compartment Location of fuse compartment with fuse holder Pry here to remove fuse holder Removing fuse holder Removing fuses US only | Instruction Manual...
  • Page 26 3 Life cycle 2 Install the correct fuse in the holder: • For 120 VAC operation, install the larger single fuse (3106-2422) into the fuse holder, see figure below. Fuse holder 120VAC • For 220 VAC operation, remove the small Phillips screw and invert the fuse clip. Install the 2 small fuses (3106-2437) into the fuse holder, see figures below.
  • Page 27 3 Life cycle 2 Plug into AC outlet. → Connecting the analyzer to a power source is completed. Loading printer paper ✓ Roll of printer paper is available To insert a paper roll into the printer, proceed as follows: 1 Make sure that the analyzer is switched off. 2 Open access door.
  • Page 28 3 Life cycle 3 Insert paper roll axle. 4 Thread printer paper. 5 Switch power on. → Loading printer paper is completed. US only | Instruction Manual PFA‑100 System | 2024-12 Print No. DCHS-E00.621.01.01.02...
  • Page 29 3 Life cycle The printer paper automatically feeds through the printhead. Threading printer paper To thread the printer paper into the printer, proceed as follows: 1 Gently pull printer paper through printer. 2 Thread paper through slot in printer door. 3 Close printer door and tear off the excess paper.
  • Page 30 3 Life cycle Loading trigger solution ✓ Trigger solution is available To insert the trigger solution bottle into the analyzer, proceed as follows: CAUTION When the access door is open, the spiking needle of the trigger solution bottle can cause injuries. Injury can result.
  • Page 31 3 Life cycle NOTICE Risk of damage to the spiking needle if the spiking needle lever is pushed down before the access door is fully closed. Damage to the system can result. ◆ Make sure the access door is fully closed before pushing the lever down. 3 Load trigger solution and close access door.

  • Page 32: Preparing The Analyzer For Longer Periods Of Non-Operation

    3 Life cycle → Loading trigger solution is completed. The system is now ready for priming. Checking for To check for correct installation, proceed as follows: correct installation ◆ Use the function Self Test from the Maintenance menu. → The analyzer has been installed correctly if the Self Test is passed without generating an error message.

  • Page 33: Disposal

    3 Life cycle 11 Store the analyzer according to the non-operating storage conditions, see ( Page 22 Ambient conditions for storage) and ( Page 96 Technical specifications). 12 Transport the analyzer carefully to an appropriate storage place. → Preparing the analyzer for longer periods of non-operation is completed. Before putting the analyzer into operation again, make sure that a new trigger solution bottle is inserted into the analyzer.
  • Page 34 3 Life cycle NOTICE Pollution due to improper waste disposal Damage to the environment can result. ◆ Contact Siemens Healthineers service with regard to disposal of the system. ◆ Do not treat electrical and electronic equipment as unsorted municipal waste. ◆...

  • Page 35: Description Of The Hardware

    Numeric keys Trigger solution Carousel compartment Components of the PFA-100 System 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 2 PFA test cartridges for sample testing. The sample to be processed is placed in the PFA test cartridge.

  • Page 36: Trigger Solution Compartment

    4 Description of the hardware Test cartridge Cassette Carousel Incubation Well Carousel 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 knob all the way up. The replaceable bottle of trigger solution is located inside this compartment.

  • Page 37: Lcd Display

    4 Description of the hardware 4.1.3 LCD display The LCD display is located on the upper front of the analyzer and displays the software commands for running samples, running control, maintenance, setup, and printing data. Display saver The system automatically turns off the LCD backlight after 5 min of inactivity following the conclusion of a test or if no key has been pressed for the same length of time.

  • Page 38: Data Connections

    4 Description of the hardware Printer Platelet Function Analyzer < Printer and printer paper slot Data connections Ports for data connections are located on the back of analyzer. Software upgrade slot Contrast adjustment External PC port Bar code scanner port Power switch Power plug Fuse compartment...

  • Page 39: Barcode Scanner Port

    The checksum is a twobyte module 65536 value. Each line has a <LF><CR> at the end. Cable connectors PFA-100 System DB-25 male connector Computer DB-9 female connector...

  • Page 40: Consumables

    4 Description of the hardware Communication parameters Baud rate 9600 Parity None Data bits Stop bits Communication parameters Consumables This chapter contains information about the consumables used for the PFA‑100 System. 4.4.1 PFA test cartridges Detailed descriptions of the PFA test cartridges, their handling, and their applications are provided in the instructions for use of each PFA test cartridge type.

  • Page 41: Configuring The System

    5 Configuring the system 5 Configuring the system This chapter describes how to configure the system. Priming the analyzer To prime the analyzer, proceed as follows: NOTICE Pollution of the incubation block with trigger solution due to a defective priming cartridge. Damage to the environment can result.

  • Page 42: Selecting The Language

    5 Configuring the system 6 Press the softkey Continue. Trigger Priming Complete Continue Remove the Cartridge, Then Press Continue When the analyzer is first powered on, at least 15 min are required to reach the operating temperature of 37 °C. When the system heater block has reached operating temperature, the dialog System Ready is displayed.

  • Page 43: Setting The Time Format

    5 Configuring the system 2 Press the numeric key 3 to select the option Setup. 1 - Run Control 2 - Maintenance 3 - Setup 4 - Print Log Previous Screen 3 Press the numeric key 1 to select the option Select Language. 1 - Select Language 2 - Set Defaults 3 - Set Date...

  • Page 44: 24-Hour Format

    5 Configuring the system 3 Press the numeric key 4 to select the option Set Time. 1 - Select Language 2 - Set Defaults 3 - Set Date Previous Screen 4 - Set Time 4 Press the softkey AM/PM for 12‑hour format. 5 Press the softkey AM or PM.

  • Page 45: Setting The Date Format

    5 Configuring the system 01:46 PM 3 To save the selection, press the softkey located next to Enter. → Selecting the time in a 24‑hour format is completed. To return to the dialog System Ready, press the softkey located next to Previous Screen twice.

  • Page 46: Setting The Patient Identification Request

    5 Configuring the system 5 To change the date, use the key < to erase the existing date, then use the numeric keys to enter the new date (enter 0 first if a single digit month or day is entered, for example, 01/01/01) (displayed from left to right).

  • Page 47: Initializing The System

    5 Configuring the system 4 Press the numeric key 2 to select the option Patient ID. 1 - Flags 2 - Patient ID 3 - Audible Keys Previous Screen 4 - LIS 5 Press the softkey Yesto enable this option (system requests an ID No. for Every Test) or press the softkey No to disable this option (system does request an ID No.

  • Page 48: Selecting Low/High Flag Ranges

    5 Configuring the system Vacuum chuck The analyzer checks that the vacuum chuck which forms a vacuum tight seal with the PFA test cartridge is functional and fully raised or at the home position. After successful completion, the message Vacuum Chuck Ok is displayed and printed. This test only checks the mechanical functions of the vacuum chuck.
  • Page 49 5 Configuring the system 4 Press the numeric key 1 to select the Flags to set the above (High Flag) and below (Low Flag) values at which a test result are be flagged with an asterisk (*) on the result printout. 1 - Flags 2 - Patient ID 3 - Audible Keys...

  • Page 50: Using Option Audible Keys

    5 Configuring the system Press the softkey located next to Previous Screen 3 times to return to the dialog System Ready. Using option Audible Keys This option allows the operator to enable or disable an audible tone to sound when a softkey or a numeric key is pressed.

  • Page 51: Selecting The Laboratory Information System (Lis)

    5 Configuring the system Press the softkey located next to Previous Screen 3 times to return to the dialog System Ready. Selecting the laboratory information system (LIS) This option allows the user to transmit the printed results to a host computer via the external PC port.
  • Page 52 5 Configuring the system To return to the dialog System Ready, press the softkey located next to Continue, and then the softkey next to Previous Screen 3 times. US only | Instruction Manual PFA‑100 System | 2024-12 Print No. DCHS-E00.621.01.01.02...

  • Page 53: Qc Procedures

    6 QC procedures 6 QC procedures WARNING False results due to insufficient maintenance of the analyzer. False results can lead to misdiagnosis and incorrect treatment. ◆ Perform the Self Test and related maintenance procedures on a regular basis, as described below. CAUTION Delay of results due to insufficient maintenance of the analyzer.
  • Page 54 6 QC procedures To initiate a system self test, proceed as follows: 1 In the dialog System Ready, press the softkey located next to Menus. System Ready Insert Sample(s) Then Press Run Print Last Run 01/11/07 10:30 AM Menus 2 In the dialog Menu, press the numeric key 2 to select the option Maintenance. 1 - Run Control 2 - Maintenance 3 - Setup...
  • Page 55 6 QC procedures NOTICE Contamination of the cleaning pad when touching it with bare fingers. Contamination may be transferred from the cleaning pad to the O-Ring during cleaning. ◆ Only touch the cleaning pads with appropriate gloves. ◆ Pay attention to the manufacturers information regarding the gloves compatibility with isopropanol.
  • Page 56 6 QC procedures 12 Remove the vacuum test cartridge from position and inspect the trigger solution dispensing. Check that the trigger solution is dispensed on the raised platform of the vacuum cup, see circle in figure below. Raised platform of vacuum cup Trigger solution dispensing The size and exact centering of the drop is not critical.

  • Page 57: Performing Run Control

    6 QC procedures Performing run control To perform a run control, proceed as follows: WARNING Infection by contaminated samples and PFA test cartridges. Death or serious injury can result. ◆ All blood samples and blood components must be treated as a potential source of infection.
  • Page 58 6 QC procedures Do not apply pressure to the sample reservoir opening. 7 In the dialog System Ready, press the softkey located next to Menus. System Ready Insert Sample(s) Then Press Run Print Last Run 01/11/07 10:30 AM Menus 8 In the dialog Menu, press the numeric key 1 to select the option Run Control. 1 - Run Control 2 - Maintenance 3 - Setup...

  • Page 59: Printing Control Results

    6 QC procedures 16 Dispose of the PFA test cartridge in a suitable biological hazard waste container. → Performing a run control is completed. Events or conditions (status messages) detected during the test run are indicated below the printed test result. See ( Page 88 Common status messages) and ( Page 93 Other status messages), for full explanation of status messages.

  • Page 60: Performing The Analysis

    7 Performing the analysis 7 Performing the analysis This chapter describes how to perform the analysis. Loading samples General information on handling and collection of blood samples as well as detailed information on performance and applications of each PFA test cartridge type is described in the specific instructions for use of the PFA test cartridge types.
  • Page 61 7 Performing the analysis WARNING False results due to mix-up of patient samples. Death or serious injury to the patient can result. ◆ Make sure to assign the PFA test cartridge position to the correct patient. WARNING Infection by contaminated samples and PFA test cartridges. Death or serious injury can result.

  • Page 62: Requesting A Test With Option Patient Id Number Disabled

    7 Performing the analysis 5 Holding the cassette with 1 or more PFA test cartridges on a flat surface, pipette 800 μL of sample into the smaller opening (sample reservoir opening) of the PFA test cartridge. Insert sample Insert sample into PFA test cartridge 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.

  • Page 63: Performing Duplicate Test Or 2 Test Types With The Same Patient Id

    7 Performing the analysis 3 Holding the cassette in one hand, remove the PFA test cartridge by gently pulling the bottom of the PFA test cartridge toward you until it unsnaps. 4 Dispose of the PFA test cartridge in a suitable biological hazard waste container. →...

  • Page 64: Requesting Test With Option Patient Id Number Enabled

    7 Performing the analysis 1 Press the softkey located next to Run in the dialog System Ready. System Ready Insert Sample(s) Run Duplicate Then Press Run Print Last Run 01/11/07 10:30 AM Menus → The analyzer starts testing and displays the processing stage of the sample (incubation or performing testing sample A or sample B).

  • Page 65: Performing Duplicate Test Or 2 Test Types With The Same Patient Id

    7 Performing the analysis 2 Use the numeric keypad or the optional barcode scanner to enter the patient ID (maximum 12 characters). 3 Holding the cassette in one hand, remove the PFA test cartridge by gently pulling the bottom of the PFA test cartridge toward you until it unsnaps. 4 Press the softkey located next to Run.

  • Page 66: Performing 2 Test Types With Different Patient Ids

    7 Performing the analysis 5 Remove the cassette carefully from the carousel: Holding the cassette in one hand, remove the PFA test cartridge by gently pulling the bottom of the PFA test cartridge toward you until it unsnaps. 6 Dispose of the PFA test cartridges in a suitable biological hazard waste container. →...

  • Page 67: Canceling Tests

    7 Performing the analysis → The analyzer starts testing and displays the processing stage of the sample (incubation or performing testing for sample A or sample B). When testing is complete, the analyzer prints and displays the results along with the respective patient ID numbers entered and test type.

  • Page 68: Printing Results

    7 Performing the analysis Printing results WARNING False results due to problems with the type code sensor or the readability of the type codes on the PFA test cartridges. This can cause a mix-up of test types in the instrument software. False results can lead to misdiagnosis and incorrect treatment.

  • Page 69: Printing Usage History

    7 Performing the analysis 2 Press the numeric key 4 to select the option Print Log. 1 - Run Control 2 - Maintenance 3 - Setup 4 - Print Log Previous Screen 3 Press the numeric key 1 to select the option Patient Results. 1 - Patient Results 2 - Control Results 3 - Usage History...
  • Page 70 7 Performing the analysis 2 Press the numeric key 4 to select the option Print Log. 1 - Run Control 2 - Maintenance 3 - Setup 4 - Print Log Previous Screen 3 Press the numeric key 3 to select the option Usage History. 1 - Patient Results 2 - Control Results 3 - Usage History...

  • Page 71: Performing Maintenance And Cleaning

    8 Performing maintenance and cleaning 8 Performing maintenance and cleaning WARNING False results or delay of results due to insufficient maintenance of the analyzer. False results can lead to misdiagnosis and incorrect treatment. Death or serious injury to the patient can result. ◆...
  • Page 72 8 Performing maintenance and cleaning WARNING Infection by contaminated parts of the analyzer. Death or serious injury can result. ◆ Make sure to disinfect the analyzer in an area designated as a biological hazard area. ◆ Wear appropriate personal protective equipment, that is, gloves, protective clothing, safety glasses, and mask.

  • Page 73: Replacing Trigger Solution

    8 Performing maintenance and cleaning Replacing trigger solution WARNING False results due to expired or unusable trigger solution. False results can lead to misdiagnosis and incorrect treatment. ◆ Do not use trigger solution whose use-by date has expired. ◆ Do not use trigger solution if turbid or if particulate matter is present. To insert the trigger solution bottle into the analyzer, proceed as follows: CAUTION When the access door is open, the spiking needle of the trigger solution bottle...

  • Page 74: Priming The System

    8 Performing maintenance and cleaning It is normal that residual solution remains in the bottle. 3 Remove the flip-top cap and insert the new bottle in place. NOTICE Risk of damage to the spiking needle if the spiking needle lever is pushed down before the access door is fully closed.
  • Page 75 8 Performing maintenance and cleaning 1 Locate the priming cartridge provided for priming the system (this cartridge is blue and does not have a top foil seal or a cup). 2 Snap the priming cartridge into the cassette. Use only 1 priming cartridge in either position or B.

  • Page 76: O-Ring Maintenance

    8 Performing maintenance and cleaning → Priming the system is completed. To return to the dialog System Ready, press the softkey located next to Previous Screen twice. O‑Ring maintenance This chapter contains information about the manual cleaning and replacement of the O‑Ring.

  • Page 77: Removing The O-Ring

    8 Performing maintenance and cleaning WARNING False results due to missing O-Ring. False results can lead to misdiagnosis and incorrect treatment. ◆ Perform the following work steps thoroughly. 3 Visually inspect the O‑Ring for debris or unusual wear and tear such as cracks. 4 If the O‑Ring requires replacement, follow the option Install O‑Ring in the Maintenance menu to install a new O‑Ring.

  • Page 78: Installing The O-Ring

    8 Performing maintenance and cleaning 3 Press the numeric key 6 to select the option Remove O‑Ring. 1 - Paper Advance 5 - Clean O-Ring 2 - Self Test 6 - Remove O-Ring 3 - Printer Test 7 - Install O-Ring 4 - Trigger Prime Previous Screen →...
  • Page 79 8 Performing maintenance and cleaning 1 In the dialog System Ready, press the softkey located next to Menus. System Ready Insert Sample(s) Then Press Run Print Last Run 01/11/07 10:30 AM Menus 2 Press the numeric key 2 to select the option Maintenance. 1 - Run Control 2 - Maintenance 3 - Setup...

  • Page 80: Cleaning O-Ring Using Cleaning Pads

    8 Performing maintenance and cleaning 8 Perform the Self Test in the Maintenance menu to verify that the system has no vacuum leak. When performing the self test to ensure proper installation of the O‑Ring, it is not required to insert a cleaning pad. 9 When prompted, press Continue to proceed with the self test.
  • Page 81 8 Performing maintenance and cleaning 4 Press the numeric key 5 to select the option Clean O‑Ring. 1 - Paper Advance 5 - Clean O-Ring 2 - Self Test 6 - Remove O-Ring 3 - Printer Test 7 - Install O-Ring 4 - Trigger Prime Previous Screen →...

  • Page 82: Replacing Printer Paper

    8 Performing maintenance and cleaning → Cleaning O‑Ring using cleaning pads is completed. The self test must be performed in the Maintenance menu. In case the self test fails, a manual O‑Ring cleaning has to be carried out. This manual O‑Ring cleaning has to be performed with the O‑Ring service tool.
  • Page 83 8 Performing maintenance and cleaning 4 Place the spindle through the paper roll and snap it into the paper holder. The paper must unroll from the top. 5 Make sure the edge of the paper is cut straight, if required cut the paper. 6 Engage the paper into the printhead, between the metallic support of the printhead and the printhead itself.

  • Page 84: Replacing Printer Ribbon

    8 Performing maintenance and cleaning → Replacing the printer paper is completed. Replacing printer ribbon ✓ Printer ribbon is available NOTICE Insufficient maintenance of the printer. Loss of data will result. If archiving of the test results is required: ◆ Take care to install the printer paper properly. ◆...
  • Page 85 8 Performing maintenance and cleaning WARNING Electric shock by contact with live parts Death or serious injury can result. ◆ Unplug the supply cable from the power supply socket before replacing the fuses. WARNING Infection by contaminated parts of the analyzer. Death or serious injury can result.

  • Page 86: Troubleshooting

    If a problem is detected, an error message is displayed and printed and the system prevents the running of a test. To take the appropriate action if a problem occurs, see ( Page 88 Common status messages). PFA-100 Self Test REV. 2.2...

  • Page 87: Displaying Test Results

    9 Troubleshooting 2 Press the numeric key 4 to select the option Print Log. 1 - Run Control 2 - Maintenance 3 - Setup 4 - Print Log Previous Screen 3 Press the numeric key 4 to select the option Error Log. 1 - Patient Results 2 - Control Results 3 - Usage History...

  • Page 88: Common Status Messages

    9 Troubleshooting Sample A: CT = >300 sec No Closure Maximum Test Time Exceeded Sample A: CT = >xxx sec No Closure Maximum Syringe Travel Reached Sample A: CT = >xxx sec No Closure Sample Depleted For more information on the status messages displayed above, see ( Page 88 Common status messages) and ( Page 93 Other status messages).

  • Page 89: Maximum Test Time Exceeded

    9 Troubleshooting Sample A: CT = >300 sec No Closure Maximum Test Time Exceeded Test terminated due to maximum syringe travel, see ( Page 92 Test terminated due to maximum syringe travel). Sample A: CT = >xxx sec No Closure Maximum Syringe Travel Reached Test terminated due to insufficient sample, see ( Page 91 Test terminated due to insufficient sample).

  • Page 90: Test Terminated Due To Air Leak

    9 Troubleshooting 9.4.2 Test terminated due to air leak The following table contains information about the circumstances in which the message TEST TERMINATED DUE TO AIR LEAK occurs and how to proceed afterwards. Description Causes Solutions/Comments Result Interpretation The analyzer has •...

  • Page 91: Test Terminated Due To Insufficient Sample

    9 Troubleshooting Description Causes Solutions/Comments Result Interpretation The analyzer has • Initial Flow Obstruction • Verify that the Non-reportable detected a sudden sample does not This type of flow obstruction occurs stoppage of blood contain clots or when the analyzer detects a failure to flow during the test.

  • Page 92: Test Terminated Due To Maximum Syringe Travel

    9 Troubleshooting Description Causes Solutions/Comments Result Interpretation The analyzer has • Not enough sample • Verify that 800 μL was added to the PFA test An insufficient sample detected air being message that occurs was loaded in the cartridge. Rerun sample using 900 μL. drawn subsequent to at a time that is PFA test cartridge.

  • Page 93: Other Status Messages

    9 Troubleshooting Description Causes Solutions/Comments Result Interpretation The analyzer has • Syringe piston • Perform a Self Test via the Maintenance A maximum syringe stopped the current travel message that moved too far too menu without the cleaning pad to rule out test because the occurs at a time that quickly as a result of...
  • Page 94 9 Troubleshooting Status messages Causes Solutions MAIN MEMORY ERROR An error occurred in the system Perform a reset by turning the analyzer operating program. off and then back on. If the problem persists, contact Siemens Healthineers service. MAXIMUM PID LENGTH EXCEEDED The patient ID entered via the barcode Abbreviate patient ID to 12 or scanner exceeds the maximum length...
  • Page 95 9 Troubleshooting Status messages Causes Solutions TRIGGER SYSTEM FAIL Air was detected coming from Make sure the trigger solution bottle the trigger solution bottle after is full. 3 successive attempts to prime Perform a reset by turning the analyzer the analyzer. off and then back on.

  • Page 96: 10 Technical Specifications

    10 Technical specifications 10 Technical specifications This chapter describes the specifications of the system and the environmental conditions. 10.1 Physical Dimensions (L x W x H) 38.4 cm x 22.9 cm x 36 cm (15.1 in x 9 in x 14.2 in) Weight 10.9 kg (24 lbs) 10.2 Electrical Operating voltage and frequency 100–240 VAC, 60 Hz 200–240 VAC, 50 Hz Current (maximum) 1.5 A/100 VAC, 0.75 A/200 VAC Power consumption (maximum)

  • Page 97: General

    10 Technical specifications 10.4 General Installation category Incubation well temperature 37.9 °C ± 1 °C Incubation well warm-up time (room to Maximum 15 min operating temperature) Incubation time 3.0 min Cassette capacity 2 PFA test cartridges Maximum sample volume 1000 μL Vacuum set point 40 mBar Sound pressure level Printing: 77 dB(A) Priming/Test: 46 dB(A) 10.5...

  • Page 98: Software

    10 Technical specifications 10.7 Software External computer RS232 Interface connector 25‑pin D‑connector Barcode scanner Optional Patient ID Maximum 12 characters Stored control results Last 50 results Stored patient results Last 20 results Software update PCMCIA card US only | Instruction Manual PFA‑100 System | 2024-12 Print No.

  • Page 99: 11 Appendix

    11 Appendix 11 Appendix This chapter describes the principle of operation and the calculation of results. 11.1 Principle of operation 11.1.1 Principle of platelet function analysis The PFA‑100 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.

  • Page 100: Quick Reference Guide

    11 Appendix Trigger solution Microprocessor Pressure transducer Syringe Membrane* Sample reservoir* Capillary* * Test cartridge Schematic view of system components and test cartridge 11.2 Quick reference guide The quick reference guide contains the steps of a routine run on the system from switching on the analyzer, preparation of the samples and the analyzer up to printing out the results of the samples, and switching the analyzer off again.

  • Page 101: Carrying Out Self Test

    11 Appendix → The analyzer initializes and heats the incubation block. System Ready Insert Sample(s) Then Press Run Print Last Run 01/11/07 10:30 AM Menus If the instrument has not been in use for a longer period of time (> 7 days), clean the O‑Ring, see ( Page 80 Cleaning O‑Ring using cleaning pads) and ( Page 101 Cleaning O‑Ring manually).

  • Page 102: Priming Trigger Solution

    11 Appendix 11.2.4 Priming trigger solution If the vacuum test fails, the O‑Ring has to be cleaned manually, proceed as follows: 1 Select Menu > Maintenance > Trigger Prime. 2 Place a priming cartridge in the analyzer and follow the instructions on the display. →...

  • Page 103: Disposal Of Used Pfa Test Cartridges

    11 Appendix 3 Mix the blood sample by inverting the collection tube gently by hand 3 to 4 times. 4 Pipette 800 μL of blood into the smaller opening (sample reservoir opening) of the PFA test cartridge by dispensing slowly along one of the inside corners. 5 Start the test: Run.

  • Page 104: Emc Performance Criteria

    11 Appendix 2 Remove the cassette carefully from the carousel. 3 Holding the cassette in one hand, remove the PFA test cartridges by gently pulling the bottom of the PFA test cartridge toward you until it unsnaps. 4 Dispose of the PFA test cartridges in a suitable biological hazard waste container. 5 After having removed the PFA test cartridges: Set the power switch on the back of the analyzer to off.

  • Page 105: 12 Revision Information

    12 Revision information 12 Revision information The revision information lists topics that have changed since the previously published version of this document. Due to a layout and authoring tool change, content has been reworked. Manual corrections have been made, for example, typos, and minor improvements due to regulatory input as well as customer and internal feedback.

  • Page 106: 13 References

    13 References 13 References This chapter lists the publications cited in this manual. Reference Publication Kratzer, MAA: Born, GVR: Simulation of Primary Hemostasis in Vitro. Haemostasis (1985) 5, 357-362 Born, GVR: Aggregation of blood platelets by adenosine diphosphate and its reversal. Nature 194:927, 1962 US only | Instruction Manual PFA‑100 System | 2024-12 Print No.

  • Page 107: Index

    Index Accessories 5 Data connections 38 Language 42 Barcode scanner port 38 Accessory LCD display 37 External PC port 38 Cassette 16 Life cycle 16 Software upgrade slot 38 Cleaning pad 16 LIS (laboratory information system) 39, 51 Fuse 16 Date format 45 Select 51 O-Ring 16 Delivery Load O-Ring service tool 16 Check delivery 16 Printer paper 27 Paper roll axle 16 Scope of delivery 21 Sample 60, 102...
  • Page 108 Index Print SMN (Siemens material number) 5 Automatic 68 Software Warranty 6 Control results 59 Self test 13 WEEE Error log 86 Specifications 98 see Directive on waste electrical and Result last run 68 Spare parts 7 electronic equipment  Results 68 Specifications Stored result 68 Electrical 96 Usage history 69 Environmental 96 Printer 37 General 97 Specifications 97 Physical 96 Printer paper 37...
  • Page 109 Instructions for Use. It is not our intention to exclude anyone. We defined modifications are not supported by Siemens Healthineers as continue to update our documentation with this in mind. they may affect performance of the system and test results. Legal Manufacturer Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany Material No.

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