2.3 Service Life
This prosthetic component has been tested by the manufacturer for 3 million load cycles accord
ing to ISO 10328. Depending on the patient's activity level, this corresponds to a service life of 3
to 5 years.
2.4 Qualification
The product may only be integrated in the prosthesis by orthopaedic technicians who have com
pleted training for the Harmony system and obtained corresponding certification.
3 Safety
3.1 Explanation of Warning Symbols
Warning regarding possible serious risks of accident or injury.
WARNING
Warning regarding possible risks of accident or injury.
CAUTION
NOTICE
Warnings regarding possible technical damage.
3.2 General Safety Instructions
WARNING
Operation of motor vehicles
Risk of accidents due to restricted body functions
►
Observe the applicable legal and insurance regulations for the operation of motor vehicles
and have your driving ability examined and certified by an authorised agency.
Inform the patient.
►
CAUTION
Using the product without following the instructions for use
Deteriorating health condition and damage to the product because of failure to follow the safety
information
►
Observe the safety information in these instructions for use.
Make the patient aware of all safety instructions marked with "Inform the patient".
►
CAUTION
Excessive strain on the product
Fall due to breakage of load-bearing components
►
Use the prosthesis components according to the MOBIS classification (see section "Area of
Application").
Inform the patient.
►
CAUTION
Unallowable combination of prosthesis components
Fall due to breakage or deformation of the product
►
Only combine the product with prosthesis components that are approved according to the
section "Combination Possibilities".
►
Based on the instructions for use of the prosthesis components, verify that they may be com
bined with each other.
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