Infrared (IR), non-contact, clinical thermometer, digital, handheld, range 34 – 42 °C, including batteries.
Indicative Price 23.05 USD
Non-contact infrared clinical thermometer including batteries.
A hand-held, electrically-powered 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. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
Measurement of skin temperature trough infrared radiation detection
IR spectral response 6,000 – 14,000 nm.
Preferred measuring distance 3 - 7 cm.
Accuracy 0.2°C in the range of 35 - 42°C.
Out of range indication required.
Display visualisation of measured temperature, low battery, and malfunction.
Display easy to read in all levels of ambient light.
Digital read-out in Celsius or Fahrenheit, user selectable.
Low and high temperature indication.
Temperature measurement range 32 – 43 °C.
Response (measurement) time within 2 s.
Ready-to-use after switch-on within 10 s.
Automatic switch-off when not in use.
Automatic self-test on switch-on.
Visual and/or audible alert on switch-on, ready-to-use and measurement completed.
Full batteries allow for a minimum of 1,000 measurements.
The unit is light weight and designed to facilitate easy operation for prolonged durations.
Designed to withstand frequent cleaning and disinfection with hospital-grade products.
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x plastic protective case with hard outer shell.
1 x set of 2 suitable alkaline batteries.
ESTIMATED LIFE SPAN
Three to five years depending on the model supplied.
Storage conditions: -20 - 60°C / 85% RH.
Operating conditions: 10 - 40°C / 30% - 85% RH.
Ingress Protection: IP21
Atmospheric pressure: 70kPa – 106kPa
WEIGHT AND VOLUME (Packaged)
Weight: 270 gr.
Volume: 1.23 dm³.
INSTALLATION / COMMISSIONING REQUIREMENTS
Other than installing the battery there are no installation or commissioning requirements.
No user training will be required.
Other than cleaning in accordance with manufactures instructions there are not specific maintenance requirements.
S0481056, Thermometer, clinical, digital, no Li
COMPONENT OF A KIT
QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.
MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDD 93/42/EEC as Class IIa device.
SAFETY AND PRODUCT STANDARDS
- ISO 80601-2-56: 2017: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature.
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- EN ISO 15223-1 (EN 980) Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements.
GMDN Code: 17888
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