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Ossur i-Digits Quantum User Manual

Ossur i-Digits Quantum
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1211
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 --:/ IEC --:  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 -- :/
IEC --: 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 manufacturers 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 Compliance Electromagnetic environment - guidance
RF emissions
CISPR 
Not applicable
Battery Powered
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.
RF emissions
CISPR 
Class B 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.
Harmonic emissions
IEC --
Not applicable
Battery Powered
Voltage fluctuations/ flicker
emissions
IEC --
Not applicable
Battery Powered

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Ossur i-Digits Quantum Specifications

General IconGeneral
BrandOssur
Modeli-Digits Quantum
CategoryMedical Equipment
LanguageEnglish

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