5
PB
ENGLISH
UNITY
®
SYSTEM COMPONENTS (Figure 2)
1. Membrane Housing
2. Pump Blade
3. Membrane
4. Inlet Port
5. Outlet Port
6. Duckbill
7. Mounting Screw
8. Tube
Flex-Foot Assure / Balance Foot J
See IFU for Flex-Foot Assure / Balance Foot J
SAFETY PRECAUTIONS
Please follow the safety precautions as failure to do so can lead to
malfunction of the Unity System and risk injury to the user.
• This product is to be used exclusively for unilateral or bilateral major
lower-limb amputations.
• Use a Unity Socket Valve Kit to connect the system to the socket.
• Make sure that the socket is a close fit to prevent blistering and/or
wounds.
• Make sure the tube is not folded, bent, or closed off in any way
(Figure 3)
.
• Make sure the tube is secured firmly away from any sharp objects or
components.
• Clinical specialists should make sure their clients are aware of and
understand the following:
– The tube must be well secured at all times.
– Never operate this product if a change in its operation is
observed. In such cases the user should consult the clinical
specialist.
caution
: U.S. federal law requires this device to be sold by a prosthetist
and by the order of a physician. The clinical specialist must provide each
user with training for appropriate use and proper application of the Unity
System.
UNITY SYSTEM OVERVIEW
The Unity System is designed to provide elevated vacuum for socket
suspension. Expected attainable vacuum achieved by the Unity System
during normal operation ranges from 15-18 inHg or higher.
With the Unity System, assisted 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.
The Unity System is designed to function in any temperature and
humidity that the user encounters during normal use.
Unity for Flex-Foot Assure / Balance Foot J is single patient device.
The users of Unity for Flex-Foot Assure / Balance Foot J are clinical
specialists and end user. This device should only be used with a
prescription from a physician that includes the necessary treatment
information.
Summary of Contents for UNITY
Page 1: ...Instructions for Use UNITY FOR ASSURE BALANCE FOOT J...
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