Otto Bock 4R44-L, Instructions For Use Manual

Page: 8 / 104

Kennzeichen 4R44=L 4R50
Material
Edelstahl, rost­
frei
Titan
Max. Körpergewicht [kg] 150
1 Product description English
INFORMATION
Last update: 2018-05-24
► 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.
1.1 Construction and Function
The 4R44=L and 4R50 adapters serve as connecting elements in
modular lower limb prostheses. They permit length compensation and
rotation adjustment. The 4R44=L adapter is a pyramid receiver with
exterior thread, the 4R50 adapter is a pyramid adapter with interior
thread.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock's system of
modular connectors. Functionality with components of other manufac­
turers that have compatible modular connectors has not been tested.
•
The 4R44=L adapter can either be connected to a lamination
anchor or with the 4R50 adapter.
2 Intended use
2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
8
2.2 Area of application
Approved for a body weight of up to 150 kg .
2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service life
This prosthetic component has been tested by the manufacturer for 3
million load cycles according to ISO 10328. Depending on the
patient's activity level, this corresponds to a service life of 3 to 5
years.
3 Safety
3.1 Explanation of warning symbols
CAUTION
Warning regarding possible risks of accident or
injury.
NOTICE
Warning regarding possible technical damage.
3.2 General safety instructions
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the product according to the specified area of application
(see Page 8).