Legal Information; Technical Data - Ottobock 4R98 Gebrauchsanweisung

3) Insert the tube adapter fully into the tube clamp adapter up to the
stop. Align the clamping slot:
Tube clamp adapter: anterior
Tube clamp adapter, sliding: anterior or medial
4) 4WR95=3 only: Apply Loctite to the tube clamp cap screw.
5) Tighten the cap screw (tightening torque according to thread dia­
meter: M4: 5 Nm, M5: 10 Nm, M6: 13 Nm).
5.2 Installation in the modular prosthesis
> Required materials: torque wrench (e.g. 710D20), 636K13 Loc­
tite 241
► Install the other prosthetic components as described in the
respective instructions for use.
5.3 Adjusting adapter
> Required tools:
710D20 Torque Wrench
> No load on the prosthesis, or the prosthesis is not being worn.
1) Loosen the cap screw of the dovetail guide (see fig. 1).
2) Move the proximal section of the sliding tube clamp adapter in the
dovetail guide. Note the maximum displacement.
3) Tighten the cap screw (assembly torque: 15 Nm).
6 Cleaning
1) Clean the product with a damp, soft cloth.
2) Dry the product with a soft cloth.
3) Allow to air dry in order to remove residual moisture.
7 Maintenance
► A visual inspection and functional test of the prosthetic compon­
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.
8 Disposal
In some jurisdictions it is not permissible to dispose of the product
with unsorted household waste. Improper disposal can be harmful to
health and the environment. Observe the information provided by the
responsible authorities in your country regarding return, collection
and disposal procedures.

9 Legal information

All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly.
9.1 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.
9.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on
medical devices. The CE declaration of conformity can be down­
loaded from the manufacturer's website.
9.3 Warranty
The manufacturer warrants this device from the date of purchase. The
warranty 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.
Further information on the warranty terms and conditions can be
obtained from the competent manufacturer distribution company.

10 Technical data

Reference number
Weight [g]
System height [mm]
Material
4R98
150
57
Aluminium
9