Section 8: Quality Assurance; Instrument Self-Test; Liquid Qc; Electronic Qc (Acttrac®) - Medtronic ACT Plus Gebrauchsanweisung

Section 8: Quality Assurance

Instrument Self-Test

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The ACT Plus instrument performs the following self-tests when powered ON:
1. The actuator assembly cycles and opens the actuator heat block assembly if
it is closed.
2. An audio beep will sound, the Startup screen will appear, and the message,
"Self-Test in Progress" will be displayed.
3. The message, "Self-Test Pass," is displayed followed by automatic transition
to the Main Menu.
Note: If any of the instrument's self-tests fail or are not completed, the
software will display the message "Self-Test: FAIL XXX," where XXX is a
3-digit number indicating a System Error Code. Record this code (if
displayed), and notify the Medtronic Service Department or an authorized
representative before continuing (refer to Section 10, Service and
Troubleshooting).
4. The temperature will be displayed automatically.
Note: Allow a minimum of 10 minutes of warm-up time for the actuator heat
block to reach the desired temperature before performing any tests. The
actual warm-up time will depend on the instrument's ambient temperature.

Liquid QC

Liquid controls are used to verify instrument and cartridge performance and
operator technique. When only liquid controls are used the minimum QC
requirements are 2 levels of control performed every 8 hours that the device is used
for patient testing. CLOTtrac
Low Range, Recalcified, and High Range Heparinase cartridges.
Electronic QC (ACTtrac
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The ACTtrac Electronic Quality Control is an interactive, mechanical,
software-controlled verification device that includes both quantitative and
qualitative results. It interacts with the ACT Plus
emulating certain functions of a test cartridge. The ACTtrac
aspects of the ACT Plus
flag sensor function, reagent delivery pin height, lift wire height, and 3-level tests
(emulated clotting time ranges).
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ACT Plus Operator's Manual
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Coagulation Controls are available for High Range,
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)
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instrument that relate to proper test cartridge function:
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instrument by mechanically
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checks the following
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