10
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
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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
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Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Not applicable
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Содержание i-Digits Quantum
Страница 1: ...i DIGITS Instructions for Use...
Страница 3: ...3 1a 2 3 1b 5 4 1 2 3 4 5...
Страница 108: ...108 i Digits My i Limb Biosim Apple Store Apple iOS iPhone iPad Apple Store i Digits i Digits i Digits i Digits 2...
Страница 109: ...109 i Digits i Digits ssur ssur ssur i Digits ssur ssur ssur ssur 15 600 800 mAh 3 LED LED 90 3...
Страница 114: ...114 ssur ssur CISPR 11 ssur RF CISPR 11 ssur IEC 61000 3 2 IEC 61000 3 3...
Страница 118: ...118 BF IP22 12 5 mm i Digits i Digits 2 6 II...
Страница 179: ...179 i Digits My i Limb Biosim Apple Store Apple iOS iPhone iPad Apple Store i Digits i Digits i Digits i Digits 2...
Страница 180: ...180 i Digits i Digits ssur ssur ssur i Digits ssur ssur ssur ssur 15 600 800 3 90 3...
Страница 185: ...185 ssur Myoelectric ssur Myoelectric CISPR 11 ssur Myoelectric CISPR 11 B ssur Myoelectric IEC 61000 3 2 IEC 61000 3 3...
Страница 189: ...189 BF IP22 12 5 i Digits i Digits 2 6 II...
Страница 192: ...192 i Digits ssur ssur ssur ssur 15 1 800mAh 1 600 1 3 LED LED LED 90 3 4 2 5 2 5 1 4 LED LED...
Страница 199: ...199 BF 4 IP22 12 5 mm i Digits i Digits 2 6 II...
Страница 208: ...208 ssur...
Страница 209: ...209 BF IP22 12 5 mm i Digits i Digits 2 6 II...
Страница 212: ...212 i Digits ssur Vaseline ssur ssur ssur 15 800mAh 600 3 LED LED LED 90 3 4 2 5 2 5 1 4 LED...
Страница 220: ...220 BF YYYY IP22 12 5mm i Digits i Digits 2 6 Class II...
Страница 222: ...222 i Digits i Digits i Digits i Digits 2 i Digits i Digits ssur ssur ssur i Digits ssur...
Страница 230: ...230 BF YYYY 12 5 IP22 i Digits 6 i Digits 2...