Quality Control; Self Test; Instrument Check - Actim 1ngeni Manual De Instrucciones

Quality control

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QUALITY CONTROL

6.1 Self test

The Self Test is an automated instrument test that occurs automatically during
the instrument start up, or as scheduled by the admin user. It can also be run by
the admin user at any time. Running self test independently from the start up and
determining the schedule for an automated test can be done using the admin
settings.
Do not insert instrument check or test cartridge into the instrument during the self test.
After the self test, the following status screens will apply:
Pass: In the start up self test case, the instrument enters the login screen.
Warning: "Self Test Warning!" is displayed. In the start up self test case: the user confirms and advances to
login screen and testing is not locked out. When requested or scheduled by the admin user: the user
confirms and returns to previous application screen. Testing is not locked out.
Fault: "Self Test Fault! Testing has been locked out" is displayed. In the start up self test case: the user
confirms and advances login screen. When requested or scheduled by the admin user: the user
confirms and returns to previous application screen. Patient and control testing is locked out.
The current self test result is available in the instrument information screen and the last passed self test is shown
in the printed report output.
Each failed Self Test is assigned a level of severity:
Fault: the Self Test Status is set to fail and the testing is locked out.
Warning: the Self Test Status is set to fail but the testing is not locked out.
Critical Failure: the Self Test Status is set to fail and the instrument reboots.

6.2 Instrument check

The Instrument Check (IC) function provides the capability to periodically check the
functions of the instrument. This check has the advantage that it is independent
of any assay and assay controls and specifically checks the instrument reading
capability using an external cartridge and printed strip standard.
Determining the outcome and frequency of the instrument check can be done at
the admin settings.
> IC METHOD / IC SCHEDULE
Instrument check can be run by pressing the test icon and choosing instrument check.
> RUN SELF TEST / SELF TEST SCHEDULE