Intended Use; Environmental Conditions; Service Life; Explanation Of Warning Symbols - Ottobock 2R8 Serie Gebrauchsanweisung

2 Intended use

2.1 Indications for use
The product is to be used solely for lower limb prosthetic fittings.
2.2 Area of application
2R8=M8, 2R31=M8, 2R54=M8 and 2R54=M10
Approved for a body weight of up to 100 kg.
2R8=M10
Approved for a body weight of up to 125 kg.
2R31=M10
Approved for a body weight of up to 136 kg (300 lbs).

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

In general, all modular adapters are tested by the manufacturer for
3 million load cycles. Depending on the patient's level of activity, this
corresponds to a service life of 3 to 5 years.
3 Safety

3.1 Explanation of warning symbols

Warning regarding possible risks of accident or
CAUTION
injury.

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 7).
CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
► Only combine the product with prosthetic components that are
approved for that purpose.
► Based on the instructions for use of the prosthetic components,
verify that they may be combined with each other.
CAUTION
Use under unallowable environmental conditions
Risk of injury due to damage to the product
► Do not expose the product to unallowable environmental condi­
tions.
► If the product has been exposed to unallowable environmental
conditions, check it for damage.
► If damage is apparent or in case of doubt, do not continue using
the product.
► Take suitable measures if required (e.g. cleaning, repair,
replacement, inspection by the manufacturer or a specialist
workshop etc.).
CAUTION
Exceeding the service life and reuse on another patient
Risk of injury due to loss of functionality as well as damage to the
product
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