En | Instructions For Use - Össur UNITY Instructions For Use Manual

ENGLISH
UNITY™ SYSTEM COMPONENTS (Figure 1)
1. Lower blade
2. Membrane
3. Upper blade
4. Washer
5. Screw
6. Membrane housing
7. Duckbill
8. Inlet port
9. Tube
10. Tube fixture
11. Outlet port
12. Heel
Vari-Flex
See IFU for Vari-Flex foot kit
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 lower part of the body.
• Use the 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 8).
• 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 it is not working properly. In such cases
the user should return the product to the clinical specialist.
Caution: 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 that the Unity™ System
achieves is ranging from 15-18 inHg.
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 provided preassembled to a Vari-Flex.
The Unity™ System is designed to function in any temperature and
humidity that the user encounters during normal use.
Note: The use of wedges can affect the number of steps needed for full
vacuum.
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