Össur PRO-FLEX LP TORSION W/UNITY Mode D'emploi page 5

ENGLISH
Unity System is referred to as the device in the following document.
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This document provides important information on the indications for
use, and handling of the device. It is intended for use by a certified
prosthetist and the user of the device. The device may only be fitted by a
qualified practitioner authorized by Össur after completing the
corresponding training.
DEVICE COMPONENTS (FIGURE 2)
1. Membrane Bolt
2. Mounting Piece
3. Anchor Blade
4. Bumper
5. Spring Blade
6. Membrane
7. Membrane Housing
8. Bumper Bolt
9. Duckbill
10. Inlet Port
11. Tube
12. Attachment Piece
13. Attachment Bolt
PRO-FLEX LP TORSION FOOT
See IFU for Pro-Flex LP Torsion.
SAFETY
Warning: A strong cautionary statement regarding possible dangers
related to the intended use or foreseeable misuse of a device.
Precaution: A cautionary statement requiring action to be taken in
advance of device use, or in the event of malfunction or change in device
performance. Intended to ensure safe and effective use of device, and to
protect the user against greater risk of harm and/or possible failure of
the device, when used as intended.
PRECAUTIONS
• U.S. federal law requires that the device is sold by a prosthetist and by
the order of a physician. The practitioner must provide each user with
training for appropriate use and proper application of the device.
• The device is to be used exclusively for unilateral or bilateral major
lower-limb amputations.
• Use a Unity
• Ensure the socket is a close fit to prevent blistering and/or wounds.
• Ensure the tube is not folded, bent, or closed off in any way (Figure 3).
• Ensure the tube is secured firmly away from any sharp objects or
components.
N.B.: Practitioners must ensure their clients are aware of, and
understand the following:
• The tube must be well secured at all times.
• Never operate the device if a change in its operation is observed. In
such cases, the user should consult their practitioner immediately.
Socket Valve Kit to connect the device to the socket.
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