iHealth PT2L Podręcznik użytkownika - Strona 13

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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

Phenomenon

Conducted

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

Table 1 – Emission

Compliance

and

CISPR 11

Group 1, Class B

IEC 61000-3-2

IEC 61000-3-3

Table 2 – Enclosure Port

Basic EMC

standard

IEC 61000-4-2

IEC 61000-4-3

IEC 61000-4-8

Electromagnetic environment

The device is intended to be used in

home healthcare environment

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