Electromagnetic Compatibility - Össur i - DIGITS Manual Del Usuario

ELECTROMAGNETIC COMPATIBILITY

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally.
WARNING: 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
and result in improper operation.
In order to regulate the requirements for EMC (Electro Magnetic Compatibility) with the aim to prevent unsafe
product situations, the BS EN 60601-1-2:2015/ IEC 60601-1-2: 2015 standard has been implemented. This standard
defines levels of electromagnetic emissions for medical devices.
The Össur Myoelectric Prosthetic Devices are manufactured by Össur hf conforms to this BS EN 60601-1- 2:2015/
IEC 60601-1-2:2015 standard for both immunity and emissions.
The i-Digits hand is suitable for use in any environment except where immersion in water or any other fluid is
possible, or where exposure to highly electrical and/or magnetic fields can occur (e.g. electrical transformers, high-
power radio/TV transmitters, RF surgical equipment, CT and MRI scanners).
Refer to further guidance below regarding the EMC environment in which the device should be used:
Guidance and manufacturer's declaration – electromagnetic emissions
Össur Myoelectric Prosthetic Devices is intended for use in the electromagnetic environment specified below.
The customer or the user of the Össur Myoelectric Prosthetic Devices should assure that it each are 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
Compliance
Not applicable
Battery Powered
Class B
Not applicable
Battery Powered
Not applicable
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Electromagnetic environment - guidance
Össur Myoelectric Prosthetic Devices use 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.
Össur Myoelectric Prosthetic Devices are 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.
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