Impulse Dynamics OPTIMIZER Lite System Patient Manual page 59

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 Lite 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
30-1000MHz
Conducted Emissions
0.15-30MHz, 230V
50Hz and 120V, 60Hz
AC Harmonic
Emissions
Voltage Fluctuations
IEC 60601-1-2 2014
Standard/Section
CISPR11, Section
6, Table 11 (Class
B, Group 2)
CISPR11, Section
6, Table 6 (Class
B, Group 2)
IEC 61000-3-2
IEC 61000-3-3
53
Compliance
Group 2, Class The Vesta Charger must
B emit electromagnetic
energy in order to perform
its intended function.
Group 2, Class
Nearby electronic
B
equipment may be
affected.
Class A
Pass
Electromagnetic
environment -
guidelines