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 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.