Notes On The Safety Modes; Instructions For Use With An Osseointegrated Implant System - Otto Bock C-Leg 3C98-3 Instructions For Use Manual

Safety
CAUTION
Overloading due to changes in body weight when carrying heavy objects, backpacks or children
> Falling due to unexpected behaviour of the product.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
► Inform the patient that the behaviour of the product can change due to increased weight. It is possible that the
swing phase may not be triggered, or triggered at the wrong time.
► Inform the patient that the maximum permissible body weight must not be exceeded due to the additional
weight.

4.9 Notes on the safety modes

CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
► The warnings/error signals (see page 51) have to be observed.
► Particular caution is necessary when using a bicycle without a freewheel (with a fixed gear).
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
► Using the product when it is defective is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety mode cannot be deactivated
Falling due to unexpected product behaviour because of changed damping behaviour.
► If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred.
► Using the product when it is defective is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected product behaviour because of changed damping behaviour.
► The warnings/error signals (see page 51) have to be observed.
► After the safety signal has been emitted, further use of the product is prohibited.
► The product must be inspected by an authorised Ottobock Service Centre.

4.10 Instructions for use with an osseointegrated implant system

WARNING
High mechanical loads due to normal or unusual situations, such as falling
> Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or fracture among other
things.
> 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.
22 C-Leg 3C98-3/3C88-3