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GLUCOMETER, blood glucose monitor (StatStrip Xpress) mg/dl

https://unicat.msf.org/cat/product/13361
STD ELAEGLUE2--

Valid Article

Former Code(s): ELAEGLUC2--
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.
UN3091
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).
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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Documents

GLUCOMETER (Nova Statstrip Xpress)

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

Definition

Handheld glucometer for the quantitative determination of glucose concentration in whole blood.

Specifications

Blood glucose in whole blood from capillary collection

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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
  • Unit of measure: mg/dl or mmol/l
  • Possible haematocrit range: 20-65 %
  • Operating temperature: 15-40°C
  • Operating relative humidity: 10-90 %
  • Result display after 6 seconds
  • Data storage: 400 results
  • Battery-operated: coin cell Lithium Manganese dioxide battery 3V CR2450

Dimensions

  • Size: +/- 150 x 82 x 46 mm
  • Weight: 360 g

Transport Dangerous Goods

  • UN3091: Lithium metal batteries packed with equipment
  • Class: 9
  • Packing instructions: 970 Section II
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
Image

Supplied with the Article

Protection box (ref: 90023): protection against dust

To be Ordered Separately

  • 200 strips: 2 boxes of 100 (ref: 42214)
  • Control solutions: low (ref. 46947), normal (ref. 46948) and high (ref. 46949)

(see related items)

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 use (because there is no interference with haematocrit).

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Note

The glucometer StatStrip Xpress (ref. 47073 and 47074) allows the determination of both glycemia and ketonemia. Measurement of ketones requires separate strips. Ordering of these strips requires validation of your medical director (ref. 46951)