Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual page 142

GUIDELINES AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMMISSIONS OF
THE INTELIO PROGRAMMER WITH INTELIO PROGRAMMING WAND 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 Intelio Programmer with Intelio Programming Wand, part of the OPTIMIZER Smart Mini System, is
intended for use in an electromagnetic environment as specified below. The customer or user of the
Intelio Programmer 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.
Caution: This equipment is not intended for use in residential environments and may not provide
adequate protection to radio reception in such environments.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and
hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is
normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or re-
orienting the equipment.
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 4 (Rated input
power < kVA)
CISPR11, Section 6,
Table 2 (Rated input
power < kVA)
IEC 61000-3-2
IEC 61000-3-3
132
Compliance
environment – guidelines
Group 1, Class A The Intelio Programmer with
Intelio Programming Wand
must emit electromagnetic
energy in order to perform its
Group 1, Class A
intended function. Nearby
electronic equipment may be
affected.
Class A
Pass
Electromagnetic