5
4 - SAFETY INFORMATION AND WARNINGS
The certified professional must inform the patient about everything in this
document that is required for safe use of this device.
Warnings for the professional user
Accessories.
The device must be used with a foot cover (foot shell) and
spectra sock, supplied with the product.
Product selection
. Carbon fiber elements (calf/shank and keel) come in
different grades of stiffness, based on the activity level and weight of the
patient. An incorrect selection may result in poor device function or increased
risk of product failure. For appropriate selection, we recommend using our
online product code selector or contacting our customer service.
Maximum patient weight.
Do not exceed the weight limit.
Risk of device
failure
.
Lifting and carrying loads.
The accumulated weight (p loads) must not
exceed the maximum weight limit.
Risk of device failure.
Installation and maintenance of the device.
Installation and maintenance
must be carried out only by a certified professional. These activities include:
removing and donning the foot shell, inspecting and replacing the spectra
sock, installation of the heel wedge, connecting the device to the prosthetic
leg, aligning the prosthetic leg.
Visual check.
Visually check for product integrity before installation.
Connection with the prosthetic leg.
Before delivering the prosthetic leg to
the patient, make sure Loctite has been applied to the screws of the
connecting adaptors and that the appropriate torque has been applied, as per
the manufacturer's indications.
Installation of the wedge
. BioStep EVO and BioStep LP are supplied with a
wedge to adjust the heel stiffness. Once the appropriate heel wedge has been
determined, secure the heel wedge with Loctite 495 Instant Adhesive (or
equivalent). Do not force the wedge forward towards the bolts or
unnecessary stress will cause bolts to fail prematurely. Please check fitting
and alignment instruction section.
Device failure.
Failure of the device may lead the patient to fall and could
lead to broken bones or other injuries requiring medical treatment.
