Service Life - Ottobock Lamination Anchors Instrucciones De Uso

Optional: For better corrosion protection, stainless steel set screws
can be replaced with titanium set screws.

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 field of application
(see Page 12).
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
Risk of injury due to change in or loss of functionality and damage to
the product
► Ensure that the approved service life is not exceeded.
CAUTION
Mechanical damage to the product
Risk of injury due to change in or loss of functionality
► Use caution when working with the product.
► If the product is damaged, check it for proper function and readi­
ness for use.
► In case of changes in or loss of functionality, do not continue
using the product (see "Signs of changes in or loss of functional­
ity during use" in this section).
► Take any necessary measures (e.g. repair, replacement, inspec­
tion by the manufacturer's customer service, etc.).
Signs of changes in or loss of functionality during use
Among other factors, changes in functionality can be indicated by an
altered gait pattern, a change in the positioning of the prosthetic com­
ponents relative to each other and by the development of noises.
13