Össur i-Digits Access, Instructions For Use Manual

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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 Electromagnetic Compatibility (EMC)
with the aim to prevent unsafe product situations, the BS EN 60601-1-2/ IEC 60601-1-2 standard has been
implemented for all Össur Myoelectric Prosthetic Devices. This standard defines levels of electromagnetic
emissions for medical devices.
The i-Digits are 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 Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 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
tocause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 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 61000-3-2 Not applicable
Battery Powered
Voltage fluctuations/ flicker emissions
IEC 61000-3-3 Not applicable
Battery Powered