Instrument Self-Testing And Calibration - QBC Diagnostics Star Operators & Service Manual

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QBC STAR™ System User's Manual
Hematological results are shown on the Liquid Crystal Display. Results are also automatically printed by the
internal thermal printer onto a 2.25-inch paper tape.
The instrument contains the following subsystems:
The centrifuge for mixing and separating the blood sample
An embedded microprocessor for machine control, blood sample analysis, and communications
Memory to store the operating system and application software
A 3.5" fl oppy drive for software updates
An internal printer
A Liquid Crystal Display to show results, prompts, and messages
Data ports for communication with optional external devices such as a LIS computer or PC, keyboard,
bar code wand, full-size external printer

Instrument Self-Testing and Calibration

Whenever instrument power is turned on (or once every 8 hours if power is left on continuously), the sys-
tem software performs a self-test to verify proper operation. The self-test checks such things as: centrifuge
motor at various speeds, emission fi lter assembly, optics assembly, light source, xenon fl ash lamp, timing
control, optical clarity and focus, internal printer, rotor timing, setup keypad. An internal quality control
label and rotor timing target are fi xed in place on the rotor assembly. These items help the system verify
that the optical measurement and centrifuge subsystems are functioning properly. See paragraph 2 on
Internal Quality Control. Printout occurs automatically.
The instrument runs a built-in calibration check every time a sample is processed. Sample integrity checks
include: statistical matching of bandlengths; ratios and absolute values for signal levels; ratios that are
used to evaluate the quality of interfaces; measurement of fl oat length; verifi cation of optics and sensors;
measurement and evaluation of sample fi ll volume. Additional tests performed as part of each assay cycle
include centrifuge speed and electro-optical verifi cation. Results are reported on tube tests only if all veri-
fi cation and integrity tests pass.
The power on self-test and sample integrity tests provide verifi cation of instrument parameters such as
timing, speed, disposable integrity, reagent stability, etc.
In addition to these checks, the system monitors the temperature inside and outside the instrument before
and during each test. The system will not allow operation of the instrument if the temperature is higher
than 40° C. This threshold insures that the sample temperature does not exceed 45° C during the assay
(when temperatures can rise).
Although the QBC STAR instrument contains a centrifuge, it is not necessary to periodically test the rotor.
Centrifuge speed measurements are verifi ed each time a sample is processed.
If any part of the self-testing or calibration process fails, a message is displayed and printed. Confi rmation
of the success of self-tests is provided by the "Ready" message. In addition, each results printout indicates
the outcome of electronic QC. If the calibration tests fail, an error message is reported.
1–4
L–000867(A)

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