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INFRARED THERMOMETER, skin no contact (Masimo TIR-1)

https://unicat.msf.org/cat/product/80207
NST EEMDTISE5--

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.
V0301010202 - Non-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
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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INFRARED THERMOMETER, skin (Masimo TIR-1)

Definition

A hand-held, battery-powered, electronic instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point.

GMDN: Infrared patient thermometer, skin [17888]

Specifications

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Quality standards

IEC 60601-1-2, 2014, edition 4, +A1 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Components

The TIR-1™ Thermometer includes:

  • The TIR-1 device
  • Two (2) AA alkaline batteries
  • Infrared sensor cover

Technical specifications

  • Infra-red sensor
  • Thermometer without contact
  • Modes
    • body
    • surface
    • room
  • Digital display
    • low battery indicator
    • date indicator
    • date/time
    • Temperature reading
    • object surface temperature indicator
    • room temperature indictor
    • bluetooth indicator
    • memory mode
    • unit of measurement °F/°C
    • error warning
  • Display range body: 34.4 to 42.2°C, precision 0.1°C
  • Temperature in Celsius or Farhenheit
  • Battery: 2 x 1.5V AA Alkaline batteries
  • Operating humidity: 15-85% relative humidity
  • Operating temperature: 10° to 40°C
  • Memory recall of up to 30 temperature readings (with date and time stamp).
  • ​Response time: 1 second
  • Can communicate via Bluetooth LE to Masimo devices

Dimensions

  • Gross weight: 220g – Weight net: 172g
  • Dimensions: 150 mm x 48.48 mm x 55.16mm (L x l x H)

Supplied with the Article

  • Delivered with 2 AA batteries
  • Instruction booklet

Instructions for use

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Storage

  • Store between -20°C to 60°C
  • Humidity: 15-95% relative humidity

MSF requirements

This is a clinical grade thermometer that will replace EEMDTISE3-- Thermoflash LX26 which is not. The Thermoflash requires a wait of 1min between each measurement while there is no waiting with the Masimo TIR-1: request in the current context of the coronavirus.

This thermometer is intended for scanning individuals or monitoring an individual for potential elevated temperatures. It is not a substitute for a clinical thermometer. Always use a clinical thermometer when high accuracy body temperature measurements are required.

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