Abbott i-STAT 1 System Manual page 138

GENERAL NOTES AND CONSIDERATIONS
1. The QC Auto P/F customization feature is only available on the i-STAT 1 handheld, and not the
i-STAT Portable Clinical Analyzer (i-STAT 200 series model).
2. In order to use the QC Auto P/F customization feature, users must have the i-STAT 1 handheld
and either the Central Data Station Version 5 or i-STAT/DE data management applications.
3. The QC Auto P/F customization feature is designed to work in the i-STAT 1 handheld control
testing pathway with all liquid QC products that are assigned control ranges in APOC's Value
Assignment Sheets (available on the APOC website: www.abbottpointofcare.com/valsheets).
QC Auto P/F is not available for third-party control materials or for APOC Calibration Verification
product.
4. With each liquid QC run, the following information is transmitted when results are downloaded to
the CDS or i-STAT/DE:
•
The QC results,
•
The eVAS file name,
•
The i-STAT cartridge and control fluid lot numbers, and
•
The overall Pass/Fail result determined for the liquid QC test run.
5. Unless numerical results have been suppressed through customization, when the results of
a liquid QC run are printed, each analyte value is displayed on the printout, along with the
corresponding control range. The symbol "<< >>" is used to indicate out-of-range results on the
printout.
6. When the i-STAT 1 handheld is customized for QC Auto P/F, non-APOC controls may be
tested in the control pathway, but the Pass/Fail assignment must be performed manually.
CAUTIONS
1. When testing liquid controls, if the handheld is customized for User Defined Reportable Ranges
and Auto Pass/Fail detection, the handheld will display the control result based upon the
customized Reportable Range setting, but will base the Auto Pass/Fail determination on the
measured analyte value, irrespective of the Reportable Range settings.
2. Use caution to protect against cuts if scanning a barcode from an open glass control ampule.
MINIMUM SOFTWARE REQUIREMENTS
The minimum handheld and data management software requirements for use of the QC Auto P/F
customization feature are summarized as follows:
System Component
i-STAT 1 handheld
Central Data Station Version 5.x
i-STAT/DE
2
Minimum Software Requirements
≥ JAMS132
≥ Version 5.26a
≥ Version 2.3
Art: 730078-01C Rev. Date: 29-Jul-14