User Manual

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OTHER STANDARDS AND COMPLIANCES
ELECTROMAGNETIC COMPATIBILITY INFORMATION
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).
For all ME EQUIPMENT and ME SYSTEMS
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic
emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Group 1
Class B
Class A
Complies
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.
The Wireless Blood Pressure 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.
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.
Guidance and manufacture’s declaration - electromagnetic emissions
Table 1