Legal Information - Otto Bock 4R108-3L Instructions For Use Manual

central countersunk screw with a 6 mm pin wrench, the extension / flexion,
abduction / adduction and rotation can be adjusted (figs. 6 and 7). After the
trial fitting has been finished, bore holes in the lower section of the adapter
through the bottom of the socket using a 4 mm bit. Insert the rolled pins to
prevent rotary movement.
The 4R109 Adapter with Pyramid allows additional angular changes at any time.
4.1 Important torque information
For definitive use, the screws must be secured with Loctite 636K13 or equiva-
lent, and the countersunk screw should be torqued to 20 Nm (14.7 ft. / lb.
177 in. / lb.)
Use the 701D1 Torque Wrench or equivalent to tighten the clamping screw
at the tube connector with a torque of 13 Nm. (9.6 ft. / lb. 115 in. / lb.)
5

Legal information

All legal conditions are subject to the respective national laws of the country
of use and may vary accordingly.
5.1 Liability
The manufacturer will only assume liability if the product is used in accor-
dance with the descriptions 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.
5.2 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 manufacturer
with sole responsibility according to Annex VII of the directive.
5.3 Warranty
The manufacturer warrants this device from the date of purchase. The war-
ranty covers defects that can be proven to be a direct result of flaws in the
material, production or construction and that are reported to the manufacturer
within the warranty period.
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