Legal Information - Ottobock 2R8 Serie Gebrauchsanweisung

Required tools and materials: Grinding tool, 710D4 torque
>
wrench, degreasing cleaning agent (e.g. 634A3 acetone), special
adhesive and hardener
parts/accessories)
1) For prosthetic feet with wooden components, roughen the con­
nection surface and remove the grinding dust.
2) INFORMATION: The foot adapter has to be glued to the
prosthetic foot. Use the specified special adhesive for this
purpose.
Mix the special adhesive and hardener well together and apply to
the connection surface.
3) Clean any soiling (e.g. caused by grease) on the metal surface of
the foot adapter to be glued with a degreasing cleaning agent.
4) Position the foot adapter on the prosthetic foot, insert the screw
and washer from below and tighten it (installation torque: 2 to
4 Nm).
5) After 3 to 4 hours, tighten the screw connection with the required
installation torque (see table).
6) Leave the glued surface to harden (16 hours at 20 °C – the time
increases for lower temperatures).
Reference Prosthetic
number foot size
[cm]
2R8=M8 All
2R31=M8
2R54=M8
2R8=M10 21-25
2R31=M10
26-30
2R54=M10
(see Page 8, table
Torque [Nm]
Prosthetic feet Prosthetic feet
with wooden with plastic com­
components ponents
40
20
20
30
6 Maintenance
► A visual inspection and functional test of the prosthetic compon­
of spare
ents should be performed after the first 30 days of use.
► Inspect the entire prosthesis for wear during normal consulta­
tions.
► Conduct annual safety inspections.
7 Disposal
This product may not be disposed of with regular domestic waste in
all jurisdictions. Disposal that is not in accordance with the regula­
tions of the country where the product is used may have a detrimental
impact on health and the environment. Please observe the information
provided by the responsible authorities in the country of use regarding
return, collection and disposal procedures.

8 Legal information

All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in
accordance with the descriptions and instructions provided in this
document. The manufacturer will not assume liability for damage
caused by disregarding the information in this document, particularly
due to improper use or unauthorised modification of the product.
8.2 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
50
the directive. The declaration of conformity was therefore created by
50
the manufacturer with sole responsibility according to Annex VII of the
directive.
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