Össur RHEO KNEE XC Instrucciones De Uso página 12

damage caused by disregard of this document, particularly due to improper use or unauthorized modification of
the device.
CE CONFORMITY
This device meets the requirements of the 93/42/EEC guidelines for medical devices. This device has been
classified as a class II device according to the classification criteria outlined in appendix IX of the guideline.
WARRANTY
For information on warranty, please see the Warranty Card
COMPLIANCE
This component has been tested according to ISO 10328 standard to three million load cycles. Depending on the
amputee's activity this corresponds to a duration of use of three to five years. We recommend carrying out regular
yearly safety checks
ISO - P - kg *)
*) Body mass limit not to be exceeded!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. The customer or user of device should
assure that it is used in such an environment.
Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonics Emissions
IEC 61000-3-2
Voltage Fluctuations/
Flicker Emissions
vIEC 61000-3-3
Compliance Electromagnetic Environment – Guidance
Group 1 The device uses RF energy only for its internal function. Therefore, its RF
emissions are low and are not likely to cause any interference in nearby electronic
equipment.
Class B The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low voltage power
Class B
supply network that supplies buildings used for domestic purposes.
Complies
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