novocure Optune NovoTTF 200A, Руководство пользователя

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Appendix C – Emitted Radiation &
Electromagnetic Compatibility
The Optune Treatment Kit and the accompanying battery charger (ICH9100) and power
supply (SPS9100) need special precautions regarding EMC and need to be installed and
put into service according to the EMC information provided below.
Portable and mobile RF communications equipment can affect the Optune Treatment Kit
system and the accompanying battery charger.
The Optune device should be used with the following cables and additional parts only:
1. CAD9100 connection cable
2. INE9000 INE Transducer array (Sterile)
3. IBH9100 battery
4. SPS9100 power supply
5. ICH9100 charger
6. Unshielded AC mains cables for indoor use only with a maximal length of 1.5m
The use of accessories, parts and cables other than those specified, may result in
increased EMISSIONS or decreased IMMUNITY of the Optune Treatment Kit.
Table 1 – Guidance and MANUFACTURER’S declaration –
ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME
SYSTEMS
Guidance and manufacturer’s declaration – electromagnetic emissions
Optune Treatment Kit
is intended for use in the electromagnetic environment specified
below. The customer or the user of
Optune Treatment Kit
should assure that it is used
in such an environment.
Emissions test Compliance Electromagnetic environment –
guidance
RF emissions CISPR 11 Group 1
Optune Treatment Kit uses RF energy
only for its internal function. Therefore, its
RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11 Class B
Optune Treatment Kit is suitable for use in
all establishments, including domestic
establishments and those directly
connected to the public low-voltage power
supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions IEC
61000-3-3 Complies