5.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der Verordnung (EU) 2017/745 über
Medizinprodukte. Die CE-Konformitätserklärung kann auf der Website des
Herstellers heruntergeladen werden.
Last update: 2020-04-07
• Please read this document carefully before using the product and ob-
serve the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the pro-
duct or in case of problems.
• Report each serious incident in connection with the product, in particu-
lar a worsening of the state of health, to the manufacturer and to the
relevant authority in your country.
• Please keep this document in a safe place.
Explanation of Symbols
Warnings regarding possible technical damage.
NOTICE
1 Application
The 21Y12 Screw Valve Kit is to be used solely for installation in thermo-
plastic transfemoral [AK] sockets.
The 21Y13 Screw Valve Kit is to be used solely for installation in laminated
transfemoral [AK] sockets.
NOTICE
Risk of loss of function due to incorrect environmental conditions. Using
the prosthetic components in incorrect environmental conditions can lead
to malfunctions of the valve up to loss of functionality.
Prosthetic components must not be exposed to corrosive elements such as
fresh water, salt water and acids. Penetration of liquids, dust, sand, etc. as
well as the use at places with excessive ambient moisture must be avoided.
10 | Ottobock
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