Otto Bock 3R15 Instructions For Use Manual page 11

Unallowable amputation types
Hip disarticulation, Hemipelvectomy
3.3 Combination possibilities
CAUTION
Failure to observe the manufacturer requirements regarding
combination possibilities
Injuries, malfunctions or product damage due to unallowable com­
bination of prosthesis components
► Based on the instructions for use of all prosthetic components
used, verify that they may be combined with each other and are
approved for the patient's field of application.
► Contact the manufacturer with questions.
INFORMATION
In a prosthesis, all prosthetic components have to meet the patient's
requirements regarding the amputation level, body weight, activity
level, environmental conditions and field of application.
Unallowable combinations
Prosthetic hip joints
3.4 Environmental conditions
CAUTION
Use under unallowable environmental conditions
Fall due to damaged product
► Do not expose the product to unallowable environmental condi­
tions (see the table "Unallowable environmental conditions" in
this section).
► If the product was exposed to unallowable environmental condi­
tions, take suitable steps (e.g. cleaning, repair, replacement,
inspection by the manufacturer or a specialist workshop etc.).
All reference numbers
Allowable environmental conditions
Temperature range: -10 °C – +60 °C
Use - Relative humidity: 0 % – 90 % (Non-condensing)
Storage/Transportation - Relative humidity: 100 %
Tyre pressure: 250 – 1100 mbar
Commercially available, solvent-free cleaning agents
Unallowable environmental conditions
Storage/Transportation: Mechanical vibrations, Impacts
Hygroscopic particles (e.g.Talcum powder), Dust, Sand, Fresh
water, Salt water, Acids, Sweat, Urine
Cleaning agents containing solvents
3.5 Reuse and lifetime
CAUTION
Reuse on another patient
Fall due to loss of functionality as well as damage to the product
► Only use the product for a single patient.
CAUTION
Exceeding the service life
Fall due to change in or loss of functionality and damage to the
product
► Ensure that the service life defined in this section is not
exceeded.
This product was tested by the manufacturer with 3 million load
cycles. Depending on the user's activity level, this corresponds to a
maximum lifetime of 5 years.
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