Service Life; Explanation Of Warning Symbols; General Safety Instructions - Ottobock 1D10 Instrucciones De Uso

2.4 Service life

This product has been tested by the manufacturer with 2 million load
cycles. Depending on the patient's activity level, this corresponds to a
service life of 2 to 3 years.
3 Safety

3.1 Explanation of warning symbols

Warning regarding possible risks of accident or
CAUTION
injury.
Warning regarding possible technical damage.
NOTICE

3.2 General safety instructions

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
► Ensure that the approved service life is not exceeded.
► Only use the product on a single patient.
CAUTION
Excessive strain on the product
Risk of injury due to breakage of load-bearing components
► Use the prosthetic components according to the MOBIS classi­
fication.
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.
10
► Based on the instructions for use of the prosthetic components,
verify that they may be combined with each other.
NOTICE
Use under unallowable environmental conditions
Damage to product due to unallowable environmental conditions
► 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.).
NOTICE
Mechanical damage to the product
Change in or loss of functionality due to damage
► 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
Decreased forefoot resistance or changes in roll-over behaviour are
noticeable indications of loss of functionality.