2.3 Environmental conditions
Allowable environmental conditions
Temperature range for use: -10 °C to +60°C
Allowable relative humidity 0 % to 90 %, non-condensing
Unallowable environmental conditions
Mechanical vibrations or impacts
Perspiration, urine, fresh water, salt water, acids
Dust, sand, highly hygroscopic particles (e.g. talcum)
2.4 Service life
Depending on the patient's level of activity, the service life of the
product is 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 area of application
(see Page 8).
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 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
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).
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