Otto Bock 3R36 - Intended use; Indications for use; Area of application; Combination possibilities

1 Notes regarding the document
English
INFORMATION
Date of last update: 2021-01-18
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Please read this document carefully before using the product
and observe the safety notices.
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Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the
product or in case of problems.
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Report each serious incident related to the product to the manu
facturer and to the relevant authority in your country. This is par
ticularly important when there is a decline in the health state.
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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
CAUTION
Warning regarding possible risks of accident or
injury.
NOTICE
Warning regarding possible technical damage.
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)
• 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
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
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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
Everyday prosthesis
MG1: indoor walker
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.
MG2: Restricted outdoor walker
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.
3.3 Combination possibilities
CAUTION
Failure to observe the manufacturer requirements regarding
combination possibilities
Injuries, malfunctions or product damage due to unallowable com
bination of prosthesis components
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