Indications For Use - Össur PRO-FLEX LP TORSION W/UNITY Mode D'emploi

DEVICE OVERVIEW
The device is designed to provide elevated vacuum for socket
suspension. Expected attainable vacuum achieved during normal
operation ranges from 15–18 inHg or higher. Assisted suspension is
obtained through a pump which draws air out from the socket in each
step creating an elevated vacuum inside the socket interface.
The device is designed to function in any temperature and humidity that
the user encounters during normal use.
The device is a single patient device.
N.B.: The device is designed to be used with Iceross Seal-In
applications are the sole responsibility of the provider.

INDICATIONS FOR USE

Prosthetic interface with suspension properties for a major lower limb
amputee; low to high impact use.
CONTRAINDICATION
Not applicable
STRUCTURAL SPECIFICATION
• Net weight: Approximately 75g including tube.
• Frame construction: Carbon fiber and aluminum frame.
Clearance and dimensions: See IFU for Pro-Flex LP Torsion.
FITTING THE DEVICE
Warning: Ensure the socket is fit securely before using the device; never
use with a loose fitting or leaking socket.
N.B.: To connect the system to a socket, a Unity Socket Valve Kit is
recommended. The use of other applications is the sole responsibility of
the provider.
• Fit the user with a prosthetic foot containing the device
• Cut the tube to correct length, and connect to the device and socket
(using the Unity Socket Valve kit).
Use the supplied tube fixture to secure the tube against the pylon. The
tube should be located medially rather than laterally to avoid damage
during ambulation. Once the device has been connected, ensure the pump
is working properly, i.e. creating vacuum during gait and not leaking air.
Retrof itting the device
Use an extended ball-end hex size 4mm torque screwdriver to 3Nm
DISASSEMBLING / ASSEMBLING THE DEVICE
The device can be disassembled in case it needs to be cleaned or for
troubleshooting purposes.
Precautions:
• The device should only be disassembled / assembled by a
practitioner.
• The inlet and outlet (Figure 4) ports on the membrane housing
should not be disassembled unless absolutely necessary. This part of
the device contains miniature duckbill valves that are easily lost and
liners, other
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