Legal Information - Otto Bock 21Y97 Instructions For Use Manual

After vacuum forming clear the cylindrical part of the pattern. Remove the wood screw and attach
the 21Y102 Pattern for Laminating by a countersunk screw (Fig. 3).
After lamination clear the area of the pattern by grinding. Remove the countersunk screw and pull
the vacuum formed socket out of the lamination socket (Fig. 4).
Press the insert ring from the inside into the socket using the enclosed screw-in aid, and attach
the lamination collar from the outside (Fig. 5).
Fill Plastilin clay into the valve opening at the lamination socket, add PEDILEN foam to the socket
attachment area and subsequently drill a hole through it, using a Forstner drill, diam. 28 mm (Fig. 6).
Apply sealing resin putty to the conical surface of the lamination collar. Press the flexible socket
into the frame. Make sure it fits accurately in the valve area (Fig. 7).
After shaping the foam, fit in the connection tube of the valve (Fig. 8).
Apply sealing resin to the valve tube, insert it into the valve opening in such a way that tube and
lamination collar are bonded to each other (Fig. 9).
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) 21Y99=10 Insert Ring*
(7) 21Y103 Seal Ring
(8) 21Y98 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.

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 accordance with the descrip-
tions 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.
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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