Intended purpose of use: Electronic device to measure a patient's body temperature.
Product description: Electronic device (without mercury) to measure the body temperature of children and adults in Celsius degrees.
Safe to use, no glass, no mercury.
Digital thermometer Celsius scale.
Liquid crystal display (LCD), easy to read.
Measurement range: 32°C to 43°C.
Accuracy: +/- 0.1°C between 35°C to 41°C.
Measurement time: 30 to 40 seconds.
Long-life battery: minimum 200 hours (about 1000 measurements).
Automatic shut-off after some minutes.
Beep sound and switch off.
Water proof for ease of cleaning.
Resistant to chlorine ("high level" disinfection).
Operating ambient temperature: from +10º C to 35º C.
Battery powered.
Low battery indicator.
Battery powered (min. 4000 measurement for full battery).
Supplied with clear instructions for use/preventive maintenance.
Instructions for use:
To measure temperature of children and adults.
It is recommended to follow the manufacturer's instructions for use / preventive maintenance.
Operating conditions: 10 - 40°C / 85% RH.
Packaging and labelling:
One (1) thermometer in storage case with manufacturer's instruction for use in English, French and Spanish.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Accessories/ spare parts/consumables:
Pack of batteries.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Im device.
Safety & product Standards:
Must comply with following standards (as per latest revision of standards):
ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device.
ISO 80601-2-56:2009. Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems.
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic. compatibility - Requirements and tests.
Environmental requirements: ISO 14001.
Material of batteries environmental friendly.
Not use of PVC.
Product description: Electronic device (without mercury) to measure the body temperature of children and adults in Celsius degrees.
Safe to use, no glass, no mercury.
Digital thermometer Celsius scale.
Liquid crystal display (LCD), easy to read.
Measurement range: 32°C to 43°C.
Accuracy: +/- 0.1°C between 35°C to 41°C.
Measurement time: 30 to 40 seconds.
Long-life battery: minimum 200 hours (about 1000 measurements).
Automatic shut-off after some minutes.
Beep sound and switch off.
Water proof for ease of cleaning.
Resistant to chlorine ("high level" disinfection).
Operating ambient temperature: from +10º C to 35º C.
Battery powered.
Low battery indicator.
Battery powered (min. 4000 measurement for full battery).
Supplied with clear instructions for use/preventive maintenance.
Instructions for use:
To measure temperature of children and adults.
It is recommended to follow the manufacturer's instructions for use / preventive maintenance.
Operating conditions: 10 - 40°C / 85% RH.
Packaging and labelling:
One (1) thermometer in storage case with manufacturer's instruction for use in English, French and Spanish.
Symbols used according ISO 15223.
CE mark with Notified Body number.
Accessories/ spare parts/consumables:
Pack of batteries.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance.
CE certificate available for Class IIa and above devices.
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016.
Classification:
Classified under EU MDR 2017/745 as Class Im device.
Safety & product Standards:
Must comply with following standards (as per latest revision of standards):
ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device.
ISO 80601-2-56:2009. Medical electrical equipment -- Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
IEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems.
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic. compatibility - Requirements and tests.
Environmental requirements: ISO 14001.
Material of batteries environmental friendly.
Not use of PVC.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $1.17 |
