iHealth BP7 Gebruikershandleiding - Pagina 13
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IEC 60601-1:2006 (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);
ANSI/AAMI SP-10:2002+A1:2003+A2:2006;
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 Wireless Blood Pressure Wrist Monitor is intended for use in the electromagnetic
environment specified below.
The customer or the user of the monitor 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 Wireless Blood Pressure Wrist Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the Wireless Blood Pressure Wrist
Monitor should assure that it is used in such an environment.
IEC 60601test
IMMUNITY test
Electrostatic
± 6 kV contact
discharge (ESD)
± 8 kV air
IEC 61000-4-2
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Compliance
The Wireless Blood Pressure Wrist Monitor uses RF
energy only for its internal function. Therefore, its RF
Group 1
emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
The monitor is suitable for use in all establishments,
Class B
including domestic establishments and those directly
connected to the public low-voltage power supply
Class A
network that supplies buildings used for domestic
purposes.
Complies
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Compliance level
level
± 6 kV contact
± 8 kV air
Electromagnetic environment - guidance
Electromagnetic environment -
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
guidance
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