Operation Manual

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 Wrist 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 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 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.
Guidance and manufacture’s declaration - electromagnetic emissions
Table 1
OTHER STANDARDS AND COMPLIANCES
The Wireless Blood Pressure Wrist Monitor corresponds to the following standards:
IEC 60601-1:2005 (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-
ELECTROMAGNETIC COMPATIBILITY INFORMATION
tary 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).
18