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Otto Bock 21Y45 - Legal Information

Otto Bock 21Y45
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Ottobock | 7
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
* An 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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