iHealth BP5 Panduan Pemilik - Halaman 11
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OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Monitor corresponds to the following standards:
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: Supplemen-
tary requirements for electro-mechanical blood pressure measuring systems);
ANSI/AAMI SP-10:2002+A1:2003+A2:2006;
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).
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ELECTROMAGNETIC COMPATIBILITY INFORMATION
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 Wireless Blood Pressure Monitor should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
Group 1
The Wireless Blood Pressure Monitor uses RF energy only for its internal function.
CISPR 11
Therefore, its RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
Class B
CISPR 11
Harmonic
Class A
The Wireless Blood Pressure Monitor is suitable for use in all establishments,
emissions
including domestic establishments and those directly connected to the public
IEC 61000-3-2
low-voltage power supply network that supplies buildings used for domestic
purposes.
Voltage fluctuations/
Complies
flicker emissions
IEC 61000-3-3
Table 1
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