Operating Conditions
50°F-104°F (10-40°C), Relative humidity, ≤RH95%,
70-106KPa
Size (Dimensions)
5.69” x 1.45° x 1.53° (144.6mm x 37.0mm x 39.0mm)
Weight
0.19lbs (87g)
High Body Temperature
≤100.4°F (38.0°C)
Waterproof Grade
IP22
Electric Shock
Internally powered ME equipment
Applied Part
Type BF applied part, including the whole unit
Mode of Operation
Continuous Operation
Battery Life
≥1000 times
Product Life
2 years
Software Version
V1.0
Note:
Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
Standard List
EN980
Symbols for use in the labeling of medical devices.
EN1041
Information supplied by the manufacturer with medical
devices.
EN60601-1
Medical electrical equipment Part 1: General requirements
for basic safety and essential performance.
EN60601-1-2
Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance.
- Collateral standard: Electromagnetic compatibility -
Requirements and tests.
EN60601-1-6
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential performance.
- Collateral standard: Usability.
EN60601-1-11
Medical electrical equipment Part 1-6: General
requirements for basic safety and essential performance.
- Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in home
healthcare environment.
EN12470-5
Clinical thermometers - Part 5: Performance of infrared ear
thermometers (with maximum device).
ASTM E1965-98
Standard Specification for Infrared Thermometers for
Intermittent Determination of Patient Temperature.
ISO 80601-2-56
Medical electrical equipment part 2-56: particular
requirements for basic safety and essential performance of
clinical thermometers for body temperature measurement.
-11-
≤109.4°F (43.0°C)
Version: 1.0.0
July 12th, 2021
