Össur Unity for Pro-Flex Pivot, Instructions For Use Manual

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4
ENGLISH
Medical Device
PRODUCT DESCRIPTION
Unity for Pro-Flex Pivot is a mechanical vacuum pump intended for
vacuum assisted prosthetic suspension. Suspension is obtained through
the act of a pump which draws air out from the socket in each step
creating an elevated vacuum inside the socket interface.
UNITY SYSTEM COMPONENTS (Fig. 2)
1. Membrane housing
2. Inlet port
3. Outlet port
4. Duckbill
5. Bolt
6. Tube
7. Tube clamp
INDICATIONS
– Lower limb amputation.
– Lower limb deficiency.
CONTRAINDICATIONS
None known.
INTENDED USE
The device is a single patient device designed for daily use. This device
should only be fitted by a healthcare professional.
It is intended to be used with the Pro-Flex Pivot Foot, FST0 foot cover
and a Unity Socket Valve Kit for connection to a suspension socket with
an Iceross
®
Seal-In Liner.
The function of Unity
®
is activated during gait, the weight placed on the
prosthetic foot expands the vacuum pump reservoir that efficiently draws
air out from the socket in each step and expels it into the atmosphere
during swing as the reservoir compresses. This pumping mechanism
creates a negative pressure at least 15 inHg inside the socket, resulting in
a secure and reliable liner suspension.
GENERAL SAFETY INFORMATION
Inform the patient about everything in this document that is required for
safe use of this device.
WARNING: In case of functional change or functional loss, the patient
should stop using the device and contact a healthcare professional.
WARNING: If the device shows signs of damage or wear hindering its
normal functions, the patient should stop using the device and contact
a healthcare professional.
ASSEMBLY
1. Visual check to make sure the bumper is properly aligned and
centered (Fig. 5) to avoid noise from the device.