Abbott i-STAT 1 System Manual

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.

Abbott i-STAT 1 Specifications

General

Brand	Abbott
Model	i-STAT 1
Category	Measuring Instruments
Language	English