16
(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),
ISO 80601-2-56:2017/AC:2018( Medical Electrical Equipment -- Part 2-56:
Particular Requirements For The Basic Safety And Essential Performance Of
clinical thermometers for body temperature measurement), ASTM
E1965-98:2016( Standard Specification for Infrared Thermometers for
Intermittent Determination of Patient Temperature).
The SAR limit of USA (FCC) is 1.6 W/kg averaged over one gram of tissue.
Device has also been tested against this SAR limit.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Frequency range
Bluetooth: 2402MHz~2480MHz
Max EIRP: 4.40dBm
Table 1 - Emiss
ion limits per environment
Phenomenon
Compliance
Electromagnetic environment
Conducted and radiated
RF emissions
CISPR 11
Group 1, Class B
The device is intended to be used in home
healthcare environment
Harmonic distortion
IEC 61000-3-2
NA
The device is powered by battery
Voltage fluctuations and
flicker
IEC 61000-3-3
NA
The device is powered by battery
Table 2 - Enclosure Port
Phenomenon
Basic EMC standard
Immunity test levels
Home Healthcare Environment
Electrostatic
Discharge
IEC 61000-4-2
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field
IEC 61000-4-3
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Proximity fields from
RF wireless
communications
equipment
IEC 61000-4-3
Refer to table 3
Rated power
frequency magnetic
fields
IEC 61000-4-8
30A/m
50Hz or 60Hz
