Legal Information - Otto Bock 21Y45 Instructions For Use Manual

Cross-cut of a socket with installed valve (Fig� 10):
(1) Flexible Socket
(2) Plastic Socket Frame
(3) PEDILEN Rigid Foam H300
(4) Outer Laminate
(5) 5R1 Socket Attachment Block
(6) Insert Ring*
(7) Seal Ring
(8) Lamination Collar
(9) Connection Tube with Seat Ring
* A n insert ring with longer thread (21Y99=14) which can be shortened
for individual requirements is available�
21Y45, 21Y95: Insulate the valve with foil and connect it to the seat ring�
Drill a hole corresponding to the valve at an appropriate place in the
prosthetic socket� Glue the seat ring to the prosthetic socket and let the
adhesive cure�

4 Legal information

All legal conditions are subject to the respective national laws of the
country of use and may vary accordingly�
4.1 Liability
The manufacturer will only assume liability if the product is used in ac-
cordance with the descriptions and instructions provided in this docu-
ment� The manufacturer will not assume liability for damage caused by
disregard of this document, particularly due to improper use or unautho-
rised modification of the product�
4.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745on
medical devices� The CE declaration of conformity can be downloaded
from the manufacturer's website�
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