Emc Guidance - IVY LS810-B Guía De Usuario

USER GUIDE
Medical devices – Application of usability engineering to medical devices
Council Directive 93/42/EECof 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993 (including Directive 2007/47/EC )
Non-invasive sphygmomanometers —Part 1: General requirements
Non-invasive sphygmomanometers.Part 3:Supplementary requirements for
electro-mechanical blood pressure measuring systems
Secondary cells and batteries containing alkaline or other non-acid electrolytes –
Safety requirements for portable sealed secondary cells, and for batteries made
from them, for use in portable applications
User Guide

EMC GUIDANCE:

Guidance and MANUFACTURER's declaration – ELECTROMAGNETIC EMISSIONS-
for all ME EQUIPMENT and ME SYSTEMS:
Guidance and manufacturer's declaration – electromagnetic emissions
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.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions IEC
61000-3-3
20
Compliance Electromagnetic environment - guidance
The device must emit electromagnetic energy in order to
Group 2 perform its intended function. Nearby electronic equipment
may be affected.
Class B
Not applicable
Not applicable
EN
EN 62366: 2008
MDD 93/42/EEC
EN 1060-1
EN 1060-3
IEC 62133:2012
Versión 1.0