MEDICAL INDICATION
The device is to be used exclusively for the exoprosthetic fitting of amputations of the lower limb.
• Unilateral transfemoral amputation
• Bi lateral transfemoral amputation
• Unilateral knee disarticulation amputation
• Bi lateral knee disarticulation amputation
INDICATIONS FOR USE
• Activity level: Moderate to high
• The device is weatherproof, meaning it withstands exposure to humid and rainy weather conditions without
damage or loss of function
Impact Level
Moderate
High
CONTRAINDICATION FOR USE
Any conditions contrary outside or beyond to the indication for use and/or guidelines contained in this document.
SAFETY
WARNING: Statement that alerts the user to the possibility of serious injury, or serious adverse reactions
associated with the use or misuse of the device.
CAUTION: Statement that alerts the user to the possibility of a problem with the device associated with its use or
misuse.
PRECAUTIONS: Please follow the safety precautions as failure to do so can lead to malfunction of the device and
risk injury to the user. Prosthetists should make sure their clients are aware of, and understand, the safety
precautions.
GENERAL SAFETY INSTRUCTIONS
It is highly recommended that the user operates with the power off prior to setting swing and stance controls, but
always use caution when walking with the power off.
1. For maximum safety use handrail when descending stairs and ramps. Particular caution is required when
carrying children down stairs.
2. Improper handling or adjustment of the device may cause the stance control to malfunction, which can
increase the risk of fall.
3. Make sure that the user is able to recognize the auditory and/or vibratory signal for power loss.
4. When malfunctions occur or the power reaches critical levels, auditory and/or vibratory warnings alert the user.
If warning signals are detected, check if the knee can provide stance control. Engage the extension lock and
proceed to walk with caution.
5. If the device loses power, the knee loses its ability to provide stance support. In such cases it is recommended
to manually engage the integrated extension lock to lock the knee in full extension. The knee allows full weight
bearing when locked.
6. Avoid any impact to the socket, frame, adapter contact, or the interface panel on the back of the device.
Damage to this panel or any of its components may cause the product to malfunction (Figure 4).
7. The device may be susceptible to electromagnetic interference from portable and mobile RF communications
devices such as mobile (cellular) telephones or other equipment, even if that other equipment complies with
CISPR EMISSION requirements.
Maximum weight limit
136 kg (300 lbs)
110 kg (243 lbs)
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