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GLUCOMETER, blood glucose monitor (Accu-Chek Instant) mg/dl

https://unicat.msf.org/cat/product/76871
STD ELAEGLUE6--

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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.
W0201060102 - Blood glucose meters
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.
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The order of this product needs to be justified and is only acceptable under certain conditions.
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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GLUCOMETER (Accu-Chek Instant)

CAUTION: The strips and control solutions, to be ordered separately, are specific to the glucometer type and brand.

Definition

A battery powered handheld device intended for the quantitative measurement of glucose levels in whole blood.

Specifications

Blood glucose in whole blood from capillary blood

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Quality standards

ISO 15197, 2013, edition 2, (confirmed 2018) In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Technical specifications

  • Measuring range: 10-600 mg/dl or 0.6-33.3 mmol/l
  • Color code bue, green, red: target range set by default at 70-160 mg/dl (3.9 - 8.9 mmol/l)
  • Unit of measure: mg/dl or mmol/l
  • Sample volume: 0.6 µl
  • Possible hematocrit range: 10 - 65 %
  • Operating temperature: 4-45°C
  • Operating relative humidity: 10-90 %
  • Result display: <4 seconds
  • Data storage: 720 results
  • Interfaces: USB: micro-B connector; Bluetooth
  • Battery-operated: coin cell battery 3V CR2032

Dimensions

  • Size: 77.1 x 48.6 x 15.3 mm
  • Weight: approx. 40 g

Supplied with the Article

Protection pouch

To be Ordered Separately

  • Test strips (ref. 7819382171)
  • Control solutions (ref. 07869525171)
  • Safety lancets

Instructions for use

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

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx

For offline access, contact your laboratory advisor.

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Maintenance

Never repair. Replace with new one if broken.

MSF requirements

Handheld automatic analyzer allowing direct and quantitative determination of glycaemia.

Analyzer authorized for a shared use.

Accurate and reliable results also for paediatric and neonate use.

Use for self-testing requires Medical Director validation, please contact your laboratory advisor.

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