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THERMOMETER, ELECTRONIC, accuracy 0.1º C + case

https://unicat.msf.org/cat/product/19053
STD SMSUTHER1D-

Valid Article

Former Code(s): -X
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.
V0301010201 - Contact digital thermometers
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
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ELECTRONIC THERMOMETER

Definition

Electronical device (without mercury) allowing to measure body temperature in Celsius degrees.

Synonym

digital thermometre

Specifications

Quality standards

ISO 80601-2-56, 2017, edition 2, +A1 2018 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Technical specifications

  • Resistant plastic body (ABS type)
  • Metal tip with temperature sensor of which the electric properties vary according to heat
  • Liquid cristal display (LCD)
  • Measurement range: from 32ºC to 42ºC minimum
  • Accuracy: 35 .5˚C ~ 39.0˚C: ±0.1˚C ; other range: ±0.2˚C
  • Measurement time: 30 to 40 seconds (depending on the model and the site)
  • Long-life battery: minimum 200 hours (about 1000 measurements)
  • On/off switch
  • Automatic shut-off after some minutes
  • Waterproof
  • Resistant to disinfectant solution
  • Operating ambient temperature: from +10ºC to +35ºC minimum
  • Memory feature is possible, but not mandatory
  • Delivered in rigid plastic case with multilingual instructions for use

Packaging & Labelling

Unit packaging.

Instructions for use

Oral, axillary or rectal use. Follow the local customs and refer to the temperature scale. Caution: in some countries, 0.5ºC are automatically added in case of axillary use (to approach the internal temperature of the body).

The thermometer must be cleaned and disinfected between each examination.

Spare batteries are not provided.

Switch off the thermometer directly after use to safe the batteries.

Precautions for Use

In VHF-settings the use of axillary thermometer is recommended. Use the thermometer as a single patient article. (1 thermometer / 1 patient)

MSF requirements

Replaces the mercury thermometer of which the sale is banned in Europe.

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