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Siemens PFA-100 System

Siemens PFA-100 System
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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.

Table of Contents

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Siemens PFA-100 System Specifications

General IconGeneral
BrandSiemens
ModelPFA-100 System
CategoryLaboratory Equipment
LanguageEnglish

Summary

About This Document

Orientation Tips

Explains conventions for page numbering, bullets, numbers, and arrows in the manual.

Abbreviations

Lists abbreviations used in the manual with their meanings.

Safe Handling

Intended Use

Describes the PFA-100 System as an in-vitro diagnostic device for platelet function analysis.

General Safety Information

Provides general safety guidelines to ensure hazard-free operation and maintenance.

Mechanical Safety

Outlines risks associated with moving parts and necessary safety precautions.

Operational Safety

Covers safety aspects related to flammable liquids, explosion risks, and general handling.

Safe Handling of Samples, PFA Test Cartridges, and Consumables

Addresses risks of infection, false results, irritation, property damage, and pollution.

Correct Functionality of the Analyzer

Highlights the importance of checking analyzer functionality for accurate results.

Safety Messages

Explains the importance of observing all safety messages to avoid hazards.

Meaning of Warning and Information Symbols

Illustrates and explains common warning and information symbols used on the analyzer.

Statutory Requirements

Lists directives and standards the PFA-100 System complies with.

Obligations of the System Owner

Outlines the system owner's responsibilities regarding national legislation.

Delivery and Installation

Delivery

Provides information on transport, delivery, and immediate post-delivery steps.

Transporting the Analyzer

States that the PFA-100 System must be handled with care during transport.

Scope of Delivery

Lists the components delivered with the PFA-100 System and its accessory kit.

Accepting Delivery

Details steps for checking the transport box and delivery for damage and completeness.

Unpacking

Provides step-by-step instructions for unpacking the PFA-100 System.

Inventory Analyzer Accessories

Instructs to open the accessories box and verify all items are present and in good order.

Installation

Covers operating conditions and worktop requirements for analyzer installation.

Operating Conditions

Details ambient conditions for storage and operation of the analyzer.

Requirements of Worktop

Outlines necessary requirements for the worktop where the analyzer is placed.

Connecting the Analyzer

Details how to connect the analyzer to the power supply and voltage requirements.

Installing Fuses

Provides step-by-step instructions for safely replacing fuses in the analyzer.

Loading Printer Paper

Provides instructions for inserting a new paper roll into the analyzer's printer.

Threading Printer Paper

Details how to thread the printer paper through the printer and close the door.

Loading Trigger Solution

Explains how to insert the trigger solution bottle into the analyzer.

Checking for Correct Installation

Describes how to verify correct installation using the analyzer's Self Test function.

Preparing Analyzer for Longer Periods of Non-Operation

Provides steps for safely taking the analyzer out of operation for storage or disposal.

Quick Reference Guide

Switching on the Analyzer

Outlines the steps to switch on the analyzer and its initialization process.

Carrying out Self Test

Guides the user on how to perform a Self Test using the Maintenance menu.

Cleaning O-Ring Manually

Details the procedure for manually cleaning the O-Ring in case of vacuum test failure.

Priming Trigger Solution

Explains how to prime the trigger solution system via the menu.

Loading Sample

Provides instructions for preparing and loading blood samples into PFA test cartridges.

Disposal of Used PFA Test Cartridge(s)

Instructs on the proper disposal of used PFA test cartridges.

Switching off the Analyzer

Guides on how to safely switch off the analyzer after removing test cartridges.

Service and Warranty

Siemens Service

Explains how to contact Siemens for repair services and software updates.

Warranty

Details the warranty terms and conditions for the analyzer.

Restricted Warranty on Wearing Parts

Lists wearing parts with restricted warranty duration and terms.

Ordering Information

Provides information on ordering spare parts and consumables.

Disposal of the Analyzer

Outlines procedures for safe disposal of the analyzer and its components.

Description of the Analyzer

Analyzer

Introduces the PFA-100 System as a benchtop analyzer and its main function units.

Carousel

Describes the carousel's function in holding and processing PFA test cartridges.

Trigger Solution Compartment

Explains the location and function of the trigger solution compartment.

LCD Display

Describes the LCD display's location and its role in showing software commands.

Keyboard

Details the composition of the keyboard, including numeric keys and softkeys.

Printer

Describes the integrated printer's location and its printing capabilities.

Consumables

Introduces the chapter on consumables used with the PFA-100 System.

Consumables Labels

Explains the meaning of various symbols used on Siemens Healthcare Diagnostics consumables.

ConsumablesParts List

Lists consumables and parts with their specifications and catalog numbers.

Technical Specifications

Presents the technical specifications of the PFA-100 System.

Physical

Details the physical dimensions and weight of the analyzer.

Electrical

Covers electrical specifications, including operating voltage and fuse details.

Environmental

Lists environmental conditions for operation and storage of the analyzer.

General

Provides general technical parameters like installation category and sound pressure level.

Software

Lists software-related parameters such as interface connectors and updates.

Data Connections

Describes the data connection ports for barcode scanners and external PCs.

Software Upgrade Slot

Explains the function of the software upgrade slot for updating analyzer software.

Laboratory Information System (LIS)

Details how to transmit results to a host computer via the external PC port.

Principle of Operation

Explains the principle behind platelet function analysis using the PFA-100 System.

Setup and Changing Configuration

Priming the Analyzer

Provides step-by-step instructions for priming the analyzer system.

Setup of the Software

Outlines the software settings that can be configured during setup.

Selecting Language

Explains how to select the desired language for the analyzer interface.

Setting the Time Format

Guides on how to set the analyzer's time format to 12-hour or 24-hour.

Setting the Date Format

Details how to change the date format displayed on the analyzer.

Patient Identification Request

Explains how to configure the system to request patient identification numbers.

Analyzer Initialization

Describes the process of analyzer initialization and its automatic diagnostic tests.

Configuration

Introduces the chapter on analyzer configuration options.

LowHigh Flag Ranges

Details how to set low/high flag ranges for flagging results outside reference ranges.

Audible Keys

Explains how to enable or disable audible tones for softkeys and numeric keys.

Laboratory Information System (LIS)

Guides on enabling or disabling the transmission of results to a host computer.

Performing Tests

Sample Loading

Provides instructions for inserting PFA test cartridges into the analyzer.

Test Request with Patient ID Number Option Disabled

Explains how to start a single test when patient ID is disabled in setup.

Single Test

Details the procedure for starting a single test without patient ID prompt.

Duplicate Test or Two Test Types, Same Patient ID

Guides on performing duplicate tests or two test types with the same patient ID.

Two Different Test Types, Different Patient ID

Explains how to perform two test types with different patient IDs.

Test Request with Patient ID Number Option Enabled

Describes prompts for patient ID entry when the option is enabled.

Single Test

Details the procedure for performing a single test with patient ID entry.

Duplicate Test or Two Test Types, Same Patient ID

Explains how to perform duplicate or two test types with the same patient ID.

Two Test Types, Different Patient ID

Guides on performing two test types with different patient IDs.

Canceling Tests

Provides steps to cancel a test, including confirmation prompts.

Printing Results

Introduces the chapter on printing test results.

Automatic Printing After Test

States that results are automatically printed after testing is complete.

Printing the Results of the Last Run

Details how to print the results of the most recent test run.

Printing Stored Test Results

Guides on printing previously stored test results from the system log.

Printing Usage History

Explains how to print analyzer usage history, including serial number and test counts.

QC Procedures

Self Test and Daily Alignment Check for Trigger Solution Dispensing

Details performing a self test for quality control and alignment checks.

Run Control

Provides steps to perform a run control for quality assurance.

Printing Control Results

Guides on printing control results stored in the system.

Cleaning and Disinfection

Cleaning the Analyzer

Details procedures for regular cleaning of the analyzer's exterior.

Disinfecting the Analyzer

Outlines the process for disinfecting the analyzer and its parts.

Maintenance

False Results or Delay of Results Due to Insufficient Maintenance

Warns about insufficient maintenance leading to false results or delays.

Replacing Trigger Solution

Provides instructions for safely replacing the trigger solution bottle.

Priming the System

Details the procedure for priming the system, especially after non-use.

O-Ring Maintenance

Introduces the chapter on manual cleaning and replacement of the O-Ring.

Maintaining and Inspecting the O-Ring

Guides on inspecting the O-Ring for debris, wear, and proper fit.

Removing the O-Ring

Details the process for removing the O-Ring using the service tool.

Installing the O-Ring

Provides instructions for installing a new O-Ring using the service tool.

Cleaning O-Ring Using Cleaning Pads

Details how to clean the O-Ring using cleaning pads and isopropanol.

Replacing Printer Paper

Guides on how to replace the printer paper roll in the analyzer.

Replacing Printer Ribbon

Details the procedure for replacing the printer ribbon cartridge.

Replacing Fuses

Provides step-by-step instructions for safely replacing fuses.

Diagnostics and Troubleshooting

Power on Diagnostics

Explains the diagnostic tests performed when the analyzer is powered on.

Self Test

Describes the analyzer's self test procedure, including vacuum leak and O-Ring cleaning.

Printing Error Log

Guides on how to print the analyzer's error log for problem diagnosis.

Displaying Test Results

Explains how test results, events, and status messages are displayed.

Common Status Messages

Lists common status messages encountered during test runs and their causes.

Maximum Test Time Exceeded

Explains the "Maximum Test Time Exceeded" message and its interpretation.

Test Terminated Due To Air Leak

Details the "Test Terminated Due To Air Leak" message, causes, and solutions.

Test Terminated Due To Flow Obstruction

Explains the "Test Terminated Due To Flow Obstruction" message, causes, and solutions.

Test Terminated Due To Insufficient Sample

Details the "Test Terminated Due To Insufficient Sample" message, causes, and solutions.

Test Terminated Due To Maximum Syringe Travel

Explains the "Maximum Syringe Travel" message, causes, and solutions.

Other Status Messages

Lists other status messages and their corresponding causes and solutions.

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