PFA-100 System – Instruction Manual (US) – Version 1.0.1
19
9 QC procedures
The PFA-100 System has a self diagnostic built in to verify proper analyzer
performance. Perform the Self Test from the Maintenance menu at least
once at the start of each shift, this is part of the QC practice. If the system
is first powered on, perform the Self Test after the initialization and power
on diagnostic tests are completed. The result of the test will be printed along
with the date and time for incorporation into the QC records.
Blood drawn from healthy adult individuals may be used as normal controls
for the PFA-100 System test. As part of the analyzer quality control, it is
recommended to test two cartridges of each new lot with a control donor, or
whenever the institution wishes to verify the performance of the system.
Refer to the PFA test cartridges instructions for use for further instructions.
A separate test mode called Run Control is used when running these
samples. The only difference between the control mode and the sample
mode is that the mode Run Control requires the entry of the lot number for
the PFA test cartridge being used, and the results are stored in a separate
database (the last 50 results are saved in memory). It is recommended that
the laboratory maintains a hard copy of the stored control results.
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.
Delay of results due to insufficient maintenance of the analyzer.
Minor or moderate injury to the patient can result.
• Perform the Self Test and related maintenance procedures on a regular
basis, as described below.
Note: The manual O-Ring cleaning has to be carried out once a week.
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