Otto Bock 4R182 Harmony P4 modular, Instructions For Use Manual, Page: 13 / 128

13
2.5 Qualification
The product may only be integrated into the prosthesis by O&P professionals who have com­
pleted training as certified Harmony experts.
•
Fabricating the total surface weight-bearing socket:
Fabricating a total surface weight-
bearing socket is required for the use of the product.
2.6 Absolute Contraindications
• Interim prosthesis
• Dialysis patient
• Effectively non-weight-bearing residual limb end
• Neuromas in the area of the residual limb
• User limitations which prevent the safe use of the product
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 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 com­
bined 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 conditions.
►
If the product has been exposed to unallowable environmental conditions, check it for dam­
age.
► 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
► Ensure that the approved service life is not exceeded.
► Only use the product on a single patient.