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Idiomas disponibles
Idiomas disponibles
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-
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bearing socket is required for the use of the product.
2.6 Absolute Contraindications
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Interim prosthesis
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Dialysis patient
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Effectively non-weight-bearing residual limb end
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Neuromas in the area of the residual limb
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User limitations which prevent the safe use of the product
3 Safety
3.1 Explanation of warning symbols
Warning regarding possible risks of accident or injury.
CAUTION
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).
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CAUTION
Unallowable combination of prosthetic components
Risk of injury due to breakage or deformation of the product
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Only combine the product with prosthetic components that are approved for that purpose.
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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.
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If the product has been exposed to unallowable environmental conditions, check it for dam
age.
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If damage is apparent or in case of doubt, do not continue using the product.
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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.
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Only use the product on a single patient.
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