Electromagnetic Compatibility (Emc); Electromagnetic Compatibility (Emc) For Top-Mounted Goggles - Interacoustics VisualEyes 515 Instructions D'utilisation

Instructions d'utilisation VisualEyes™ 515/525 - FR

6.5 Electromagnetic compatibility (EMC)

6.5.1

Electromagnetic compatibility (EMC) for top-mounted goggles

Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC)
and needs to be installed and put into service according to the EMC information provided.
Caution
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closed than 30 cm (12 inches) to any part of the VNG including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
The VNG was tested for EMC compliance as a Group 1, Class B device.
Caution
Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation. Contact Micromedical for
approved replacement parts.
Important
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.
Guidance and manufacturer's declaration – electromagnetic emissions
The VNG is intended for use in the electromagnetic environment specified below. The customer or the
user of the VNG should assure that it is used in such an environment.
Emissions test
RF emissions CISPR 11
RF emissions CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The VNG is intended for use in the electromagnetic environment specified below. The customer or the
user of the VNG should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge immunity
(ESD)
IEC 61000-4-2
Compliance
Group 1
Class B
Class B
complies
IEC 60601 test level
+/- 6 kV contact
+/- 8 kV air
Electromagnetic environment - guidance
The VNG uses RF energy only for its internal
functions. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
The VNG 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.
Compliance level
+/- 6 kV contact
+/- 8 kV air
Page
Electromagnetic
environment –
guidance
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
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