Care And Maintenance; Usage Environment - Össur BALANCE Instrucciones Para El Uso

FOLLOW UP
Adjustments should be re-assessed within a month as the user gains
experience over time with the prosthesis.

CARE AND MAINTENANCE

To ensure user safety, check the knee for wear and tear and adjust the
settings at least once a year.
If any deterioration in performance is found, adjust the knee as required
or discontinue use.
To clean the knee wipe with soft cloth moistened with small amount of
general purpose oil (3 in 1) or sewing machine oil.
When using the knee use the shin ferrule at all times.
CAUTION! Avoid placing hands or fingers near
moving joints.
Avoid exposure to sand or other particles as the brake may be damaged.
DO NOT use talcum powder to minimize friction noises.
DO NOT use solvents or compressed air to clean the knee.
DO NOT lubricate the knee.

USAGE ENVIRONMENT

Avoid using the knee outside of the temperature range:
-10°C to 40°C.
Knee should be stored in a clean and dry environment when not in use.
The knee is designed for operation in relative humidity levels ranging
from 0% to 100%, but should be limited to non-condensing
environments.
24 months limited warranty.
LIABILITY
The manufacturer recommends using the device only under the specified
conditions and for the intended purposes. The device must be
maintained according to the instructions for use. The manufacturer is
not liable for damage caused by component combinations that were not
authorized by the manufacturer.
CE CONFORMITY
This device meets the requirements of the 93/42/EEC guidelines for
medical devices. This device has been classified as a class I device
according to the classification criteria outlined in appendix IX of the
guideline.
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
8
ISO - P -
*) Body mass limit not to be exceed!
For speci c conditions and limitations of use see
manufacturer's written instructions on intended use!
kg *)