iHealth KD-557BT Manuel du propriétaire - Page 15

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OTHER STANDARDS AND COMPLIANCES

The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:

IEC 60601-1:2005+C1:2006+C2:2007(Medical electrical equipment – Part 1: General

requirements for safety);

IEC 60601-1-2:2007 (Medical electrical equipment – Part 1: General requirements for

safety; Collateral Standard-Electromagnetic compatibility - Requirements and tests);

EN 1060-1: 1995 + A1: 2002 + A2: 2009 (Non-invasive sphygmomanometers - Part 1:

General requirements);

EN 1060-3: 1997 + A1: 2005 + A2: 2009 (Non-invasive sphygmomanometers - Part 3:

Supplementary requirements for electro-mechanical blood pressure measuring systems);

AAMI/ANSI 80601-2-30：2009/IEC 80601-2-30：2009+Cor.2010/EN

80601-2-30:2010(Medical electrical equipment –Part 2-30: Particular requirements for the

basic safety and essential performance of automated non-invasive sphygmomanometers).

ELECTROMAGNETIC COMPATIBILITY INFORMATION

Guidance and manufacture ' s declaration - electromagnetic emissions

The KD-557BT is intended for use in the electromagnetic environment specified below.

The customer or the user of the KD-557BT should assure that it is used in such an environment.

Emissions test

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/

flicker emissions

IEC 61000-3-3

Guidance and manufacturer ' s declaration - electromagnetic immunity

The KD-557BT is intended for use in the electromagnetic environment specified below. The customer or

the user of the KD-557BT should assure that it is used in such an environment.

IMMUNITY test

Electrostatic

discharge (ESD)

IEC 61000-4-2

Power frequency

(50/60 Hz)

magnetic field

For all ME EQUIPMENT and ME SYSTEMS

Compliance

Group 1

Class B

Not applicable

For all ME EQUIPMENT and ME SYSTEMS

IEC 60601test level

± 6 kV contact

± 8 kV air

3 A/m

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Table 1

Electromagnetic environment - guidance

The KD-557BT uses RF energy only for its internal

function. Therefore, its RF emissions are very low and are

not likely to cause any interference in nearby electronic

equipment.

The KD-557BT is suitable for use in all establishments

other than domestic and those directly connected to the

public low-voltage power supply network that supplies

buildings used for domestic purposes.

Table 2

Compliance level

± 6 kV contact

± 8 kV air

3 A/m

Electromagnetic environment

- guidance

Floors should be wood, concrete

or ceramic tile. If floors are

covered with synthetic material,

the relative humidity should be

at least 30 %.

Power frequency magnetic fields

should be at levels characteristic

of a typical location in a typical