Legal Information - Otto HarmonyP3 4R147 Instrucciones De Uso

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the tubing is not crimped or compressed in any way. The flange can be glued in place if necessary:
apply thin layer of glue to flange surface and press into place. Once flange is secure, any extra
tubing can be cut to length or simply pressed into the cosmesis until end of tubing is flush with flange.
Note: To achieve the best cosmetic appearance, we recommend that the foam cover is finished
with a Soft Touch stockinette.
Note: If salt appears on the outside of the stockinette, it can be washed away with warm water.
5 Maintenance
Ottobock recommends replacing the 4X147 Functional Ring after approximately 1 year of use
because the stiffness and restoring force can decrease over time. As this part is subject to wear,
its replacement can become necessary at an earlier or later point in time in dependence of the
activity and environmental conditions. Reduced shock absorption and slower generation of vacuum
are typical indicators the patient may notice.
Note: New Functional Rings may feel stiffer for the patient on the initial days of use.
If vacuum performance decreases without a corresponding decrease in shock absorption per-
formance, one or both of the valves may have become clogged with debris. The best remedy is
to replace the valves. Blow any accumulated debris out of the Functional Ring using compressed
air while the valves are removed.
When replacing the Functional Ring at the recommended service interval, wipe all old grease
from the shaft and bearings, apply new grease, and replace the two o-rings on the shaft. These
o-rings do not affect vacuum performance. They are used to cushion undesirable but necessary
movement in the bearing system.

6 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
6.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip-
tions and instructions provided in this document. The manufacturer will not assume liability for
damage caused by disregard of this document, particularly due to improper use or unauthorised
modification of the product.
6.2 CE conformity
This product meets the requirements of the European Directive 93 / 42 / EEC for medical devices.
This product has been classified as a class I device according to the classification criteria outlined
in Annex IX of the directive. The declaration of conformity was therefore created by the manufac-
turer with sole responsibility according to Annex VII of the directive.
20 | Ottobock ­armonyy3 44147