Safe Handling; Intended Use - Siemens PFA-100 System Instruction Manual

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Safe handling

2.1

Intended use

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