Össur PROPRIO FOOT PSX02 Instrucciones Para El Uso página 15

• this device must accept any interference, including interference that may cause undesired operation of this
device.
Caution: Exposure to Radio Frequency Radiation – The installer of this radio equipment must ensure that the
antenna is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general
population; consult Safety Code 6, obtainable from Health Canada's website www.hc-sc.gc.ca/rpb
REPORT OF SERIOUS INCIDENT
Any serious incident in relation to the device must be reported to the manufacturer and relevant authorities.
DISPOSAL
The device and packaging must be disposed of in accordance with respective local or national environmental
regulations.
LIABILITY
Össur prosthetic devices are designed and verified to be safe and compatible in combination with each other and
custom-made prosthetic sockets with Össur adapters, and when used in accordance with their intended use.
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.
Compliance
The device has been designed and tested according to the applicable international standards or in-house defined
standards when no international standard exists or applies.
Compatibility and compliance with these standards are achieved only when Össur products are used with other
recommended Össur components.
The device has been tested by an independent accredited laboratory and found to comply to:
• EN60601-1:2006/A1:2013
• EN60601-1-2:2015
This device has been tested according to ISO 10328 standard to two million load cycles.
Depending on patient activity this may correspond to 2-3 years of use.
Category
Moderate Impact
1
2
3
4
5
6
7
8
*Actual test loads reflect maximum body mass
ISO - "P" - "m"kg *)
Body mass limit not to be exceeded!
*)
see manufacturer's written instructions on
intended use!
ISO 10328 - Label
Weight (Kg)
52 ISO10328 – P3* – 52 kg
59 ISO10328 – P3* – 59 kg
68 ISO10328 – P3 – 68 kg
77 ISO10328 – P4 – 77 kg
88 ISO10328 – P4 – 88 kg
100 ISO10328 – P5 – 100 kg
116 ISO10328 – P5 – 116 kg
125 ISO10328 – P5 – 125 kg
Label Text
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