Guidance And Manufacturer's Declaration - ADC Adtemp 433 User Manual

Calculated values of the indicators according to ISO 80601-2-56
Forehead mode:
Bias
Standard deviation
Limits of agreement
Clinical repeatability
(for All Groups)
Calculated values of the indicators according to ASTM E1965-98
Bias (Xd)
Uncertainty
Clinical repeatability
Compared with equivalent device
Safety classification of ME equipment
Protection against electric shock:
Applied part:
Protection against harmful
ingress of water or
particulate matter:
Mode of operation:
Note: Not intended to be sterilized. Not for use in an oxygen rich environment.

13. Guidance and Manufacturer's Declaration

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.
Harmonic emissions IEC 61000-3-2
Voltage Fluctuations/flicker emissions
16
Group A1
0.015
0.123
0.245
0.071
Guidance and manufacture's declaration - electromagnetic emission
Emission test
RF emissions CISPR 11
RF emission CISPR 11
IEC 61000-3-3
Group A2
0.000
0.121
0.243
Group I
(Infants)
0.05
±0.20
Internally powered ME equipment
Non applied part
IP22
Continuous operation
Group B Group C
-0.042 -0.040
0.121 0.137
0.243 0.274
Group II Group III
(Children) (Adults)
0.07 -0.04
±0.19 ±0.18
0.13
-0.06
Compliance
Group 1
Class B
Not applicable
Not applicable