18
19
Complied European Standards List
Contact Information
AUTHORIZED COMPONENT
EN 60601-1:2006/AC:2010
EN 62304:2006/AC:2008
EN 60601-1-6:2010
EN 60601-1-11:2010
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 60601-1-2:2007/AC:2010
EN/ISO 14971:2007
EN 980:2008
EN 1041:2008
EN 1060-4:2004
Risk Management
Labeling
User Manual
Generl Requirements
for Safety
Non-invasive
Sphygmomanometers
General
Requirements
Electromagnetic
Compatibility
For more information about our products, please visit www.actiivfitness.com
EMC guidance
Table 1 – Guidance and
MANUFACTURER
’
S
declaration –
ELECTROMAGNETIC EMISSIONS
–
for all
ME EQUIPMENT
and
ME SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 2
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an
environment.
The device must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may be affected.
EMC GUIDANCE
