Impulse Dynamics OPTIMIZER Integra CCM-D - Page 61

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IEC 60601-1-2 2014
GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC
EMMISSIONS OF THE GUARDIO 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 Guardio Charger, part of the OPTIMIZER Integra CCM-D System, is intended for use
in an electromagnetic environment as specified below. The customer or user of the
Guardio 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
Standard/Section
Compliance
Electromagnetic
environment -
guidelines
Radiated Emissions
30-1000MHz
CISPR11, Section
6, Table 11 (Class
B, Group 2)
Group 2, Class
B
The Guardio Charger
must emit electromagnetic
energy in order to perform
its intended function.
Nearby electronic
equipment may be
affected.
Conducted Emissions
0.15-30MHz, 230V
50Hz and 120V, 60Hz
CISPR11, Section
6, Table 6 (Class
B, Group 2)
Group 2, Class
B
AC Harmonic
Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations
IEC 61000-3-3
Pass