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G.6 Auto-EQC
The automatic running of an EQC test at least once per day has been added to the IRMA System. Whether or not a report is
sent to the IRMA System Printer is configurable by the user.
There are three options for configuring whether or not Auto-EQC tests are printed:
•
All: All Auto-EQC tests will automatically be printed.
Fail Only: Only Auto-EQC tests that fail will be automatically
•
printed.
•
No Print: Auto-EQC tests will not be automatically printed.
•
When the print setting has been configured press the DONE
button.
Note: EQC tests are performed by the IRMA Base� The
IRMA Base will attempt to wake the IRMA Tablet when an
Auto-EQC test is started� If the IRMA Base cannot connect
to the IRMA Tablet, the EQC test will be performed, but it
will not be printed automatically�
G.7 Demo OID Allowed
The ability to disable Demonstration Mode has been added.
To configure if the IRMA System may be placed into Demonstration
Mode. There are two options for Demo OID Allowed.
Disabled: The IRMA System may not be placed into
•
Demonstration Mode.
Enabled: The IRMA System may be placed into
•
Demonstration Mode by using the Demo Mode OID.
Note: Any changes made in Settings while the
instrument is in Demonstration Mode are permanent
and will persist into patient and QC testing�
Demonstration Mode is intended for use by sales
personnel demonstrating the use of the IRMA System
and should not be enabled for any other purpose�
G.8 Interferences
Table A.1 in section A.3 of the IRMA System User Manual is replaced by the following:
Interference studies were based on CLSI document EP7 (3rd edition) and CLSI document EP37 (1st edition.) Serum or whole
blood was spiked with potentially interfering substances and tested using the CC cartridge reporting all analytes (pH, pCO
pO
, Na+, K+, iCa and Hct.) The concentrations tested and the observed effects are shown in Table G.1 below.
2
Interfering Substance
Acetaminophen
1.03 mmol/L
Acetylsalicylate
167 µmol/L
Ammonium
151 µmol/L
Ascorbic Acid
298 µmol/L
Bicarbonate
28.9 mmol/L
Bilirubin-Conjugated*
684 µmol/L
Bilirubin-Unconjugated*
684 µmol/L
Concentration
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
No significant difference in results in comparison to control results.
Expected Effect
G.5
9 Apéndices
,
2
Table G.1
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