spinit® User Manual
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spinit® system description
7
Internal process control
The instrument self
-
test
A self
-
test is performed during start
-
up of the instrument to ensure that the instrument is oper-
ating according to established specifications. The self
-
test validates:
•
Hardware and software integrity
The fail
-
safe mechanisms
The spinit® instrument is designed to be maintenance free by the user and it performs multiple
functional and operational tests to guarantee proper performance. A Hardware Mainte-
nance
procedure is performed on a periodic and automatic basis.
External process control
Patient ID
The spinit® patient ID function will, if enabled, allow 100 000 number of patients to be entered.
The Patient ID will be stored with each patient test result in the results panel.
Operator ID
The spinit® operator function will, if configured, allow the operators to insert their identification
before testing.
The operator ID will be stored with each test result in the results panel.
Quality Control
For manufacturer recommendations see Frequency of control testing page 21.
Calibration
The spinit® instrument has been manufactured to deliver reliable and accurate results. During
manufacturing, the instruments are calibrated against a reference system. This procedure has
been established to ensure that all instruments operate within identical tolerance limits.
Each spinit® test has its own lot specific calibration data coded on the barcode of the disc pouch
label. The instrument verifies that the spinit® test is valid by reading the unique QR code printed
on each disc to confirm the correct calibration. A plug
-
and
-
play barcode reader is provided to this
effect.
