Intended Use; Product Description - Otto Bock 3R20 Instructions For Use Manual

11.2 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.
1 Notes regarding the document
INFORMATION
Date of last update: 2020-04-24
► Please read this document carefully before using the product
and observe the safety notices.
► Instruct the user in the safe use of the product.
► Please contact the manufacturer if you have questions about the
product or in case of problems.
► Report each serious incident in connection with the product, in
particular a worsening of the state of health, to the manufacturer
and to the relevant authority in your country.
► Please keep this document for your records.
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)
English

3 Intended use

3.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fit­
tings.
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