Impulse Dynamics OPTIMIZER Smart Mini Patient Manual page 52

GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC
EMMISSIONS OF THE VESTA CHARGER PURSUANT TO:
IEC 60601-1-2 2014, Edition 4.0 - Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests
The Vesta Charger, part of the OPTIMIZER Smart Mini System is intended for use in an
electromagnetic environment as specified below. The customer or user of the Vesta
Charger must ensure that it is used within the specified environment.
There may be potential difficulties in ensuring electromagnetic compatibility in other
environments, due to conducted as well as radiated disturbances
Emissions Test
Radiated Emissions
CISPR 11: 2009 + A1:2010
Conducted Emissions
CISPR 11: 2009 + A1:2010;
FCC 18
AC Harmonic Emissions
IEC 61000-3-2:2014
Voltage Flicker
IEC 61000-3-3:2013
IEC 60601-1-2 2014
Compliance
Group 1, Class B
Group 2
Class A
Pass for all parameters
46
voltage power supply
network which supplies
buildings used for
domestic purposes.
Electromagnetic
environment -
guidelines
The Vesta Charger must
emit electromagnetic
energy in order to perform
its intended function.
Nearby electronic
equipment may be
affected.
The Vesta Charger must
emit electromagnetic
energy in order to perform
its intended function.
Nearby electronic
equipment may be
affected.
Class A equipment is
equipment suitable for use
in all establishments other
than domestic buildings,
and Class B equipment is
equipment suitable for use
in domestic
establishments and in
establishments directly
connected to a low
voltage power supply
network which supplies
buildings used for
domestic purposes.