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iHealth PT2L Manual

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General requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and Tests),IEC 60601-1-11 (Medical
electrical equipment – Part 1-11: General requirements for basic safety and essential
performance – Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment),the ASTM
(American Society for Testing and Materials) E 1965 - 98 , ISO 80601-2-56 ( Medical
Electrical Equipment -- Part 2-56: Particular Requirements For The Basic Safety And
Essential Performance Of clinical thermometers for body temperature
measurement).Please note that portable and mobile HF communication systems may
interfere with this unit.
This infrared thermometer meets requirements established in ASTM Standard (E1965-98)
except of clause 5.2.2. It‘s display range is 34.0℃-43.0℃(93.2℉-109.4℉).the Full
responsibility for the conformance of this product to the standard is assumed by
manufacturer.
ELECTROMAGNETIC COMPATIBILITY INFORMATION
Table 1 – Emission
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
… 13


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