Warnings - iFIT TF 300 User Manual

PATIENT ADVISORY WARNINGS
The prosthetic socket must be securely buckled at all times
when you are standing or walking. The buckles must be
completely closed so that the locking mechanism prevents
them from opening. Your limb must be completely in the
socket and the pin suspension system fully engaged—you
should not be able to pull the device off of your limb.
Your iFIT prosthetist will select the other components that
accompany the socket according to your body weight and
activity level. These include the prosthetic knee, silicone
pin suspension liner and foot. If your weight or activity level
changes, or if your prosthesis becomes less comfortable,
please notify your healthcare provider.
The socket should be comfortable to wear. If you have
any discomfort, alert your iFIT prosthetist. The healthcare
provider will test your ability to use the device while in their
clinic to ensure you can use it safely and properly.
To minimize the chances of any problems occurring, this
prosthetic device has undergone extensive engineering
testing by iFIT Prosthetics. You should always wear a silicone
locking liner (this is the liner with a pin attached) that is
compatible with the suspension in the device. You should
also ensure it is buckled tightly and securely to prevent
rotation during walking.
You must carefully follow the directions of your iFIT
prosthetist and the instructions contained in this brochure.
Failure to do any of the following could result in tripping
and falling, device failure, skin breakdown, or cause other
serious harm.
• The pin attached to the silicone locking liner should be
fully inserted into the bottom of the socket prior to use.
Check to see that the socket does not pull off once you
engage the pin. You will hear a clicking noise as the pin
locks into the locking mechanism.
• Be sure to check that the prosthesis is firmly attached
to your limb.
• If your silicone liner is worn out replace it with one
prescribed by your healthcare provider that works with
the iFIT prosthesis system. The silicone liner should be
trimmed higher than the prosthesis to prevent rubbing/
skin breakdown.
• Do not stand or walk without buckling all buckles and
checking to ensure that they are locked.
• Do not make adjustments to the buckles while standing.
Sit down and then make any buckle adjustments.
• The prosthesis must fit snuggly and comfortably around
your leg to work properly. Loosening the buckles too much
may alter walking and lead to falls.
• Let your prosthetist know if there are any areas of
excessive rubbing or pinching so they can modify
the socket.
• The iFIT transfemoral (above knee) prosthesis is not
designed for vigorous activities such as running.
• If there is pain in the limb, reduce the tightness of the
buckle one notch. Buckling too tight may cause excess
pressure or reduce blood flow to the limb. If the pain
continues despite loosening the buckle, take it off and
contact your healthcare provider.
• Only a certified iFIT prosthetist may fit and align
this device.
• Do not wear the prosthesis without a protective silicone
locking liner (with pin) which is supplied by your
healthcare provider.
• If the inner liner shows signs of excessive wear or tears
please contact your prosthetist to have it replaced.
• Do not rest or sleep with the prosthesis against your
opposite leg. Doing so may cause skin irritation
or breakdown.
As with any prosthesis there are always potential problems
that may arise. It is important that you use the iFIT Prosthesis
exactly as described in this guide. Failure to do so may result
in one or more of the following problems:
1. Prosthetic failure.
2. Residual limb skin breakdown.
3. Pain in residual limb with use of the prosthesis.
4. Risk of fall while using the prosthesis.
5. Reduced circulation (blood flow) to a limb if it is buckled
too tightly.
If you have any concerns with your prosthesis please
contact your iFIT prosthetist first.
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