Ce-Konformität; Explanation Of Warning Symbols; Product Description; Intended Use - Ottobock 3R20 Instrucciones De Uso

11.2 CE-Konformität
Das Produkt erfüllt die Anforderungen der europäischen Richtlinie
93/42/EWG für Medizinprodukte. Aufgrund der Klassifizierungskriteri­
en nach Anhang IX dieser Richtlinie wurde das Produkt in die Klasse I
eingestuft. Die Konformitätserklärung wurde deshalb vom Hersteller in
alleiniger Verantwortung gemäß Anhang VII der Richtlinie erstellt.
1 Notes regarding the document
INFORMATION
Last update: 2018-10-24
► Please read this document carefully before using the product.
► Follow the safety instructions to avoid injuries and damage to the
product.
► Instruct the user in the proper and safe use of the product.
► Please keep this document in a safe place.
This document and the product are intended exclusively for the fabric­
ation of a prosthesis by orthopaedic technicians with technical know­
ledge of lower limb prosthetic fittings.

1.1 Explanation of warning symbols

Warning regarding possible risks of accident or
CAUTION
injury.
Warning regarding possible technical damage.
NOTICE

2 Product description

The product (3R20, 3R36) has the following key features:
• Polycentric prosthetic knee joint
• Product components for stance phase stability
- Polycentric kinematics (adjustable extension stop)
14
• Product components for swing phase control:
- Extension assist (adjustable spring force)
- Adjustable friction brake as movement resistance for exten­
sion and flexion
• Material: Steel (3R20), Titanium (3R36)

3 Intended use

English
3.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
3.2 Area of application
CAUTION
Excessive strain on the product
Fall due to breakage of load-bearing components
► Only use the product according to its allowable field of applica­
tion.
Allowable field of application (3R20, 3R36)
Recommended mobility grade: 1 + 2
Allowable body weight: ≤ 100 kg
The patient has the ability or the potential to use the prosthesis for
the purpose of moving or proceeding slowly on level floors. The
amount of time and the distance he/she can walk are seriously lim­
ited due to his/her condition.
The patient has the ability or the potential to walk slowly with the
prosthesis and to negotiate low environmental obstacles like curbs,
single steps or uneven surfaces. The amount of time and the dis­
tance he/she can walk are seriously limited due to his/her condition.
MG 1: indoor walker
MG 2: Restricted outdoor walker
Everyday prosthesis