QUALITY CONTROLS - 5
VerifyNow System User Manual Page 26 14340.J
Level 2
WQC
Run before the first use of each new lot
(or shipment) of assay device kits.
Run during troubleshooting to resolve
unexpected events. Refer to Chapter 10,
Troubleshooting.
Run when the assay device kit
temperature indicator shows exposure to
elevated temperatures. Refer to Chapter
4, Reagent Storage and Handling.
Run every 30 days (only for IIb/IIIa
assay).
Use as part of your institution’s quality
control program
Verifies instrument performance by
checking that actual results are within
a higher range of values.
The following sections provide a detailed description of the procedures.
5.1 Electronic Quality Control
Electronic Quality Control (EQC) is the primary quality control mechanism for the
VerifyNow Instrument. It consists of a re-usable device that is inserted by the
operator into the assay port and is used to perform a comprehensive testing routine
that confirms performance of key instrument components.
This procedure involves a reusable EQC device and takes up to two minutes. If a
fault is detected in any of its systems, the instrument cannot perform patient testing
until the fault is corrected.
Use the following procedure to perform an EQC:
NOTE: Pressing the Back key will stop the EQC test at any point and return to
the main menu.
1.
Power on the instrument using the power switch on the back panel (“I” designates
on). The instrument will power on and perform a self-testing routine lasting
approximately 30 seconds. After the self-testing is complete, the start screen will
display. Press the Next key to advance to the main menu (Error! Reference
source not found.). The instrument should be allowed to warm-up for at least 15
minutes prior to use.
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