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

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

Valid Article

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.
S
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 measuring system suitable for self testing - intended for monitoring glucose levels in capillary blood by health care workers or patients

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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
  • Color code blue, green, red; target range set by default at 70-160 mg/dl (3.9 - 8.9 mmol/l)
  • Unit of measure: mg/dl
  • 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. 43g (with batteries)

Supplied with the Article

  • Accu-Chek Instant glucometer (mg / dl)
  • FastClix lancing device
  • 10 lance tips
  • 10 test strips
  • Meter case
  • User manual
  • 2 CR2032 batteries

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.

Storage

Storage temperature: -25 to 70°C

MSF requirements

Glucometer suitable for shared use when testing by health care worker and for self testing‌ by the patient.

Accurate and reliable results also for paediatric and neonate use.

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