Abbott i-STAT User Manual
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Symbols: Symbols can be useful in reducing the necessity for translating
important information into multiple languages, particularly where
space is limited. The following symbols may be found on
components of the i-STAT System.
For information related to Article 33
of the EU REACH regulation
(EC No. 1907/2006), please refer
to PMIS.abbott.com. If you have
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Abbott Point of Care Inc.
100 and 200 Abbott Park Road
Abbott Park, IL 60064 • USA
Art: 726064-00J
03P75-02
(01)00054749001415
Emergo Europe
Molenstraat 15
2513 BH The Hague
The Netherlands
Rev. Date: 13-Feb-17
i-STAT
User Guide
©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.
®

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Summary of Contents for Abbott i-STAT

  • Page 1 Abbott Park, IL 60064 • USA 2513 BH The Hague The Netherlands ©2017 Abbott Point of Care Inc. All rights reserved. Printed in USA. i-STAT is a registered trademark of the Art: 726064-00J Rev. Date: 13-Feb-17 Abbott Group of Companies in various jurisdictions.
  • Page 2: System Components

    Appendix 1: i-STAT 1 Wireless Analyzer Labels System Components Note: Pictured below are the three different labels that the i-STAT 1 Wireless Analyzer may have. This label can be found on the back of the analyzer. i-STAT Cartridges Analyzers whose label contains a triangle in the upper right corner are referred to as having Wireless Module FCC ID: PI405W (Firmware: 6.5.X.X/X.X,...
  • Page 3 Quality Check Messages and Codes Blood Collection (continued) Acceptable Samples for Cartridges Message Cause Action Arterial: Plain syringe, heparinized syringe labeled for analytes to be tested and filled to capacity, or syringe with minimum volume of heparin to prevent clotting (10 U/mL of blood). Sample Positioned Cartridge underfilled.
  • Page 4 CHEM8+ Cartridges Message Action Electronic Simulator Test Required Insert Electronic Simulator. CHEM 8+ cartridges require the use of whole blood collected in non- heparinized evacuated tubes or syringes, as long as sample is tested Stored Memory Low Place analyzer in Downloader. immediately upon draw, or;...
  • Page 5 When results do not reflect the patient’s condition, repeat the test using a fresh cartridge and sample. If results are still suspect, test the lot of cartridges in use with i-STAT control solutions. If the controls are in range, there may be an interfering substance in the sample.
  • Page 6 20 – 700 70 – 105 70 – 105 equipment supplied by your i-STAT distributor. Other batteries and rechargers may affect test 0.20 – 7.00 0.70 – 1.05 0.70 – 1.05 results and pose other hazards to operators and patients.
  • Page 7 5.47 – 6.80 TriControls EC8+, EG6+, EG7+, CG8+ mmol/L (mEq/L) 5-50 23 – 27 24 – 29 ACTk, ACTc i-STAT ACT controls (on the CHEM8+ cartridge only) PT/INR i-STAT PT/INR controls mmHg 5 – 800 80 – 105 0.7 – 106.6 10.7 –...
  • Page 8 Calculated: Quality Assurance Handheld Reportable Reference Range Test Units Range (arterial) (venous) Electronic Simulator Perform an electronic check on each handheld in use once a day with either the internal or Hemoglobin/Hb g/dL 5.1 – 25.5 12 – 17 12 – 17 external Electronic Simulator or as needed for regulatory compliance.
  • Page 9 Note: For analyzers containing Wireless Module FCC ID: P1405W, users must install a Without Downloader or Downloader/Recharger LAN Cable Filter (Abbott L/N 06F23-63) on all Downloader/ Rechargers that are used Turn printer on if green power light is not on.
  • Page 10 Note If there are unsent results remaining in the handheld Transmitting Results Wirelessly to Communication at the completion of a transmission attempt, a the Data Management System Ended “Communication Ended” message will appear on the handheld indicating how many unsent results are left. Unsent: 4 Note 1: Users must follow site specific guidelines for operating wireless devices.

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