iHealth BP5 Manuale d'uso - Pagina 14

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iHealth BP5 Manuale d'uso
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 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 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
IEC 60601test
test
Electrostat
± 6 kV contact
For all ME EQUIPMENT and ME SYSTEMS
Compliance
The Wireless Blood Pressure Monitor uses RF
energy only for its internal function.
Group 1
Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby
electronic equipment.
The MONITOR is suitable for use in all
Class B
establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network that
Class A
supplies buildings used for domestic purposes.
Complies
For all ME EQUIPMENT and ME SYSTEMS
Compliance level
level
± 6 kV contact
Table 1
Electromagnetic environment - guidance
Table 2
Electromagnetic environment -
Floors should be wood,
guidance
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