iHealth PT3SBT Panduan Pengguna - Halaman 16
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(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
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 - Emission limits per environment
Phenomenon
Conducted and radiated
RF emissions
Harmonic distortion
Voltage fluctuations and
flicker
Phenomenon
Electrostatic
Discharge
Radiated RF EM field
Proximity fields from
RF
wireless
communications
equipment
Rated
power
frequency
magnetic
fields
for
body
temperature
Compliance
CISPR 11
Group 1, Class B
IEC 61000-3-2
NA
IEC 61000-3-3
NA
Table 2 - Enclosure Port
Basic EMC standard
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
16
measurement),
Electromagnetic environment
The device is intended to be used in home
healthcare environment
The device is powered by battery
The device is powered by battery
Immunity test levels
Home Healthcare Environment
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
10V/m
80MHz-2.7GHz
80% AM at 1kHz
Refer to table 3
30A/m
50Hz or 60Hz
ASTM