iHealth Wireless Blood Pressure Monitor - Manual (Page 14)

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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
Table 1
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacture’s declaration - electromagnetic emissions
The Wireless Blood Pressure 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 Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Wireless Blood Pressure Monitor 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 MONITOR is suitable for use in all
establishments, including domestic
establishments 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
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
Table 2
For all ME EQUIPMENT and ME SYSTEMS
Guidance and manufacturer’s declaration - electromagnetic immunity
The Wireless Blood Pressure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the Wireless Blood Pressure
Monitor should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601test
level
Compliance level
Electromagnetic environment -
guidance
Electrostat ± 6 kV contact ± 6 kV contact Floors should be wood,