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Abbott i-STAT 1 User Manual

Abbott i-STAT 1
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©2017 Abbott Point of Care Inc. All rights reserved.
Printed in USA. i-STAT is a registered trademark of the
Abbott Group of Companies in various jurisdictions.
i-STAT
®
Art: 714254-01S Rev. Date: 13-Feb-17
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Abbott Point of Care Inc.
100 and 200 Abbott Park Road
Abbott Park, IL 60064 • USA
For information related to Article 33
of the EU REACH regulation
(EC No. 1907/2006), please refer
to PMIS.abbott.com. If you have
issues logging into the website,
contact Abbott at:
.......................
abbott.REACH@abbott.com.
Message Cause Action
Analyzer Error, Use
Electronic
Simulator
Handheld detects
problem from which it
is likely to recover.
Insert the Electronic Simulator. If
PASS, continue to use handheld.
Analyzer Error,
See Manual
Handheld detects
problem from which it
may not recover.
Insert Electronic Simulator. If PASS,
insert a cartridge with sample
or control. If the code does not
reappear, continue to use handheld.
No display Disposable batteries
dead or rechargeable
battery fully
discharged. Keypad
not responding. Start
switch broken.
Change disposable batteries or
recharge battery. If still no display,
call Support Services.
Cartridge Locked
does not disappear
after test cycle
completed
Dead battery(s).
Mechanical
problem.
Wait until handheld turns off. Turn
handheld on. If resets, remove
cartridge. If not, change or recharge
battery(s) and turn handheld on.
Quality Check Messages and Codes (
continued)
06F16-57
(01)00054749002139
i-STAT
®
1
User Guide

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Abbott i-STAT 1 Specifications

General IconGeneral
Device TypeHandheld blood analyzer
DisplayLCD touchscreen
Sample TypesWhole blood, plasma, serum
Operating Temperature15°C to 30°C
Weight0.6 kg
Battery LifeApproximately 8 hours of continuous use
Test TypesBlood gases, electrolytes
ConnectivityUSB, Bluetooth
Test CartridgesSingle-use cartridges
Storage Temperature-20°C to 55°C

Summary

System Components

i-STAT 1 Analyzer

Overview of the i-STAT 1 Analyzer device.

Electronic Simulator

Description of the Electronic Simulator component.

i-STAT 1 Downloader/Recharger

Description of the Downloader/Recharger component.

i-STAT Printer

Description of the i-STAT Printer component.

Martel Printer

Description of the Martel Printer component.

Troubleshooting

Unexpected Results

Steps to take when test results do not match patient condition.

Blood Collection

Acceptable Samples for Cartridges

Guidelines for collecting blood samples for various cartridge types.

Arterial

Specific instructions for arterial blood collection.

Venous

Specific instructions for venous blood collection.

Skin puncture

Specific instructions for skin puncture blood collection.

Coagulation Tests

Specific instructions for coagulation test sample collection.

CHEM8+ Cartridges

Troponin I/cTnl, B-hCG and CK-MB Tests

BNP Tests

Limitations

Charging Rechargeable Battery

Cleaning the Handheld and Downloader

Replacing Paper in the Martel Printer

Hardware Procedures

Replacing Batteries

Instructions for replacing disposable batteries in the handheld.

Charging the Rechargeable Battery

Procedure for placing the handheld in the Downloader/Recharger.

Patient Test Procedures

Cartridge Test Procedure

Step-by-step guide for performing a cartridge test.

Reviewing Test Results

Reportable and Reference Range

Table of reportable and reference ranges for various tests.

Verification of Cartridges Using 2 Levels of Specified Controls

Transmitting Results

Storage Conditions and Preparation for Use

Cartridges

Storage guidelines for i-STAT cartridges.

Analyzer

Storage and operating temperature ranges for the analyzer.

Handheld

Storage and operating conditions for the handheld device.

Quality Assurance

Electronic Simulator

Procedures for performing quality assurance checks with simulators.

Reportable and Reference Range (continued)

Calculated

Reportable and reference ranges for calculated values.

Test Flags and Operator Action

Printing Test Results from a i-STAT Printer or Martel Printer

Without Downloader or Downloader/Recharger

Instructions for printing results without a downloader.

With Downloader or Downloader/Recharger

Instructions for printing results with a downloader.

Printing more than one result

Procedure for printing multiple test records.

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