Legal Information - Ottobock 1S101 SACH+ Gebrauchsanweisung

> Required materials: degreasing cleaner (e.g. 634A58 isopropyl
alcohol), 636N9 contact adhesive or 636W17 plastic adhesive
1) Measure the length of the foam cover on the prosthesis and add
the length allowance.
TT prostheses: Distal allowance for movement of the prosthetic
foot.
TF prostheses: Allowance proximal of the knee rotation point for
flexion of the prosthetic knee joint and distal allowance for move­
ment of the prosthetic foot.
2) Cut the pre-shaped foam cover to length and fit it in the proximal
area on the prosthetic socket.
3) Pull the foam cover over the prosthesis.
4) Set the connecting element onto the footshell or prosthetic foot.
Depending on the version, the connecting element engages in the
edge or rests on the foot adapter.
5) Install the prosthetic foot on the prosthesis.
6) Mark the outer contour of the connecting element on the distal
face of the foam cover.
7) Disassemble the prosthetic foot and remove the connecting ele­
ment.
8) Clean the connecting element using a degreasing cleaner.
9) Glue the connecting element onto the distal face of the foam cov­
er according to the marked outer contour.
10) Let the glue dry (approx. 10 minutes).
11) Install the prosthetic foot and adapt the exterior cosmetic shape.
Take into account compression caused by cosmetic stockings or
SuperSkin.
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.
14
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 o n
medical devices. The CE declaration of conformity can be down­
loaded from the manufacturer's website.