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Calculated values of the indicators according to ISO 80601-2-56
Forehead mode:
Group A1 Group A2 Group B Group C
Bias 0.015 0.000 -0.042 -0.040
Standard deviation 0.123 0.121 0.121 0.137
Limits of agreement 0.245 0.243 0.243 0.274
Clinical repeatability
(for All Groups)
0.071
Calculated values of the indicators according to ASTM E1965-98
Group I Group II Group III
(Infants) (Children) (Adults)
Bias (Xd) 0.05 0.07 -0.04
Uncertainty ±0.20 ±0.19 ±0.18
Clinical repeatability 0.13
Compared with equivalent device -0.06
Safety classification of ME equipment
Protection against electric shock: Internally powered ME equipment
Applied part: Non applied part
Protection against harmful
ingress of water or
particulate matter: IP22
Mode of operation: Continuous operation
Note:
Not intended to be sterilized. Not for use in an oxygen rich environment.
Guidance and manufacture’s declaration - electromagnetic emission
The Infrared Body Thermometer is intended for use in the electromagnetic environment specified below. The
customer or the user of the Infrared Body Thermometer should assure that it is used in such an environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emission CISPR 11 Class B
Harmonic emissions IEC 61000-3-2 Not applicable
Voltage Fluctuations/flicker emissions
Not applicable
IEC 61000-3-3
13. Guidance and Manufacturer’s Declaration
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