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

ACT_CH.fm 6/23/04 1:23 pm
UC200304151c ML
5.5" x 7.75" (139.7 mm x 196.85 mm)

Section 8: Quality Assurance

Instrument Self-Test

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. Three audio beeps 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 Service and Troubleshooting on page 44).
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 coagulation controls are used to verify instrument cartridge performance
and end-user technique. When only liquid controls are used, minimum
requirements are two levels of control for every 8 hours of patient testing.
®
CLOTtrac Coagulation Controls are available for High-Range, Low-Range,
Recalcified, and High-Range Heparinase cartridges.
Electronic QC (ACTtrac
®
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™ instrument by mechanically emulating certain
functions of a test cartridge. The ACTtrac
Plus™ instrument that relate to proper test cartridge function: flag sensor function,
reagent delivery pin height, lift wire height, and three-level tests (emulated clotting
time ranges).
38 English
86702-001 Rev 1.0
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checks the following aspects of the ACT
ACT Plus™ Operator's Manual
Medtronic Confidential
CS010