QUALITY CONTROL
14
Art: 714376-00M
Rev. Date: 31-Jan-12
14-1
Overview
This section describes the steps to be taken to verify the performance of the
analyzer and cartridges. The rationale for the i-STAT cartridge and analyzer
quality regimen is described in the Theory section of this manual.
Customization
The quality control behavior of the analyzer can be customized via the Central
Data Station or analyzer Customization Change function to:
• turn the external Electronic Simulator reminder on or off.
• prompt the operator to use the external Electronic Simulator at
scheduled intervals.
• turn the internal Electronic Simulator on or off , and select the
simulator test cycle intervals.
• disable further cartridge testing when the internal Electronic
Simulator test fails.
See the Customization section for default values.
Data Retention
Quality control data is transmitted to the Central Data Station. If a Central
Data Station is not being used, the charts at the end if this section can be used
to record liquid and electronic control results.
QUALITY CONTROL FOR i-STAT CARTRIDGES AND THE ANALYZER’S CARTRIDGE TEST CYCLE
Verify Performance of
Analyzers Daily
Verify the performance of each analyzer on site using the Electronic Simulator
(external or internal) once a day on the days the analyzers are in use. Note that
regulatory or accreditation requirements may dictate more frequent intervals.
Verify Newly Received
Cartridges
1. Verify that the transit temperatures were satisfactory using the four-
window temperature indicator strip included in the shipping container.
2. From each lot in each shipment of cartridges, analyze multiple levels of
i-STAT controls (and RNA
®
Medical controls if testing for hematocrit)
using any verified analyzer.*
* This is not a manufacturer's system instruction; it is a suggestion to
comply with regulatory requirements.
Check Refrigerator
Storage Daily
Verify that the cartridges stored in the refrigerator are within the expiration
date printed on the boxes.
Verify that the storage refrigerator did not exceed the temperature limits of 2 to
8 °C (35 to 46 °F). If storage conditions are in doubt, use controls to verify that
the cartridges are performing properly. This is especially important if freezing
conditions are suspected at the back of the refrigerator.
Summary of Contents for i-STAT 1
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