4.10 Instructions for use with an osseointegrated implant system
WARNING
High mechanical loads due to normal or unusual situations, such as falling
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Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or fracture among other
things.
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Damage or breakage of the implant system or its components (safety components...).
► Verify compliance with the fields of application, conditions of use and indications according to the information
of the manufacturers, both for the knee joint and for the implant system.
► Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system.
5 Scope of Delivery and Accessories
Scope of Delivery
•
1 pc. Kenevo 3C60=ST (with threaded connector)
or
•
1 pc. Kenevo 3C60 (with pyramid connector)
•
1 pc. 757L16-4 power supply
•
1 pc. 4E70* inductive charger
•
2 pc. 4H108 16° flexion stop
•
1 pc. 647G1415 instructions for use (qualified personnel)
•
1 pc. 646D1321, 646D1321=1 instructions for use (user)
•
1 pc. cosmetic case for battery charger and power
supply
Accessories
The following components are not included in the scope of delivery and may be ordered separately:
•
3S26 cosmetic foam cover
•
Kenevo Protective Cover 4X840
6 Charging the prosthesis battery
The following points must be observed when charging the battery:
•
Use the 757L16-4 power supply and 4E70* battery charger to charge the battery.
•
The full surface of the inductive charger must be in contact with the receiver of the charging unit. This must be
verified, particularly when fabricating a cosmetic foam cover. Prior to application, check the contact surfaces
for dirt and ensure that no objects are adhering to them.
•
The capacity of a fully charged battery is sufficient for one full day.
•
We recommend charging the product once a day when used by the patient on a daily basis.
•
For the maximum operating time with one battery charge, disconnecting the battery charger from the product
only immediately before using the product is recommended.
•
The battery should be charged for at least 3 hours prior to initial use.
•
Note the permissible temperature range for charging the battery (see Page 34).
•
The battery may discharge while the product is not being used.
•
The tube adapter must be connected before disconnecting the battery charger, otherwise an error message
will result (see Page 37).
Kenevo 3C60/3C60=ST
Scope of Delivery and Accessories
•
1 pc. AXON 2R17 tube adapter or
•
1 pc. 2R20 AXON tube adapter or
1 pc. 2R21 AXON tube adapter with torsion
•
2 pc. 4H107 8° flexion stop (already installed on
delivery)
•
1 pc. 647F542 prosthesis passport
•
1 pc. card holder for prosthesis passport
•
"4X445=V K-Soft" adjustment software
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