iHealth KD-557BT, Owner'S Manual, Page: 15 / 17

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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
Table 1
For all ME EQUIPMENT and ME SYSTEMS
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 Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
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.
RF emissions
CISPR 11
Class B
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.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Table 2
For all ME EQUIPMENT and ME SYSTEMS
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 IEC 60601test level Compliance level
Electromagnetic environment
- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±
6 kV contact
±
8 kV air
±
6 kV contact
±
8 kV air
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
(50/60 Hz)
magnetic field 3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical