Valid Article

Former Code(s): ELAEANAL1--
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
W02010690 - Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
The order of this product needs to be justified and is only acceptable under certain conditions.
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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The i-STAT is a handheld device for the automated, quantitative determination of clinical chemistry parameters using cartridges for single use.


Analyser performing panel of tests (to be ordered separately) with following parameters:

  • blood gases
  • electrolytes
  • coagulation
  • hematology
  • glucose
  • creatinine
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Technical specifications

  • Sample: whole capillary blood, venous or arterial blood, immediately without anticoagulant, or Li+ Heparin anticoagulant
  • Operating conditions
    • Temperature between 16 and 30°C
    • Relative humidity max. 90% without condensation
  • Measuring time: 2 min
  • Data output:
    • Alphanumerical display
    • Optional external printer
  • Power supply: battery operated (2 x 9V lithium)

Transport Dangerous Goods

  • UN3496: Batteries, nickel metal hydride
  • Class: 9
  • Packing instructions: 970
  • Not restricted as per special provision IATA A199 and special provision IMDG 963

Supplied with the Article

  • Electronic simulator, ref 06F11-01 (ELAECCHA122)
  • Downloader/recharger DRC-300 04P73-04 (ELAECCHA123)
  • Battery, lithium 9V, 2 pieces, ref 06F21-26

To be Ordered Separately

  • Test cartridges
  • Control solutions (3 levels)
  • Sample collection material
  • Printer, ref 04P74-04
  • Printer paper, ref 6F17-11
  • Ceramic conditioning cartridge,for cleaning, ref 04J51-01
  • Spare lithium batteries 9V, ref 06F21-26 or a rechargeable battery, ref 06F23-55

Instructions for use

To use with various cartridges that have different test panels

Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

For offline access, contact your laboratory advisor.

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A calibration every 6 months is mandatory (online), please contact your Biomed advisor for support.

MSF requirements

Simple device allowing to carry out rapid, point-of-care clinical chemistry analysis.

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