Description Of Symbols; Product Description; General Safety Instructions - Ossur Unity Gebrauchsanweisung

ENGLISH

DESCRIPTION OF SYMBOLS

Medical Device

PRODUCT DESCRIPTION

Unity for Balance Foot S & Balance Foot S Torsion is a mechanical
®
vacuum pump designed for vacuum assisted prosthetic suspension
systems. It uses the compression of the prosthetic foot to provide
elevated vacuum for socket suspension.
Components (Fig. 1)
1. C Blade
2. C Blade Mounting Piece
3. Duckbill valves
4. Inlet Port
5. Outlet Port
6. Tube
7. C Blade Bolts
8. Tube Clamp
INDICATIONS FOR USE
Lower limb amputation.
CONTRAINDICATIONS
None known.
INTENDED USE
The device is intended to for continuous use by a single user to provide
vacuum-assisted prosthetic suspension. It should be used with the
Balance Foot S or the Balance Foot S Torsion, a Spectra sock, and a Unity
Socket Valve Kit for connection to a suspension socket with an Iceross
Seal-In Liner.

GENERAL SAFETY INSTRUCTIONS

Inform your patient about everything in this document that is required
for safe use of this product.
WARNING: Misuse of this product may result in loss of vacuum, leading
to loss of suspension and potential fall.
WARNING: In cases of functional change or functional loss, the patient
should stop using the device and contact a medical professional.
ASSEMBLY
1. Attach the device to the prosthetic foot. Apply Loctite 243 and tighten
the bolts to 5 Nm (Fig. 2). Make sure the device is properly aligned
with the prosthetic foot. (Fig. 3 and 4)
2. Tube Connection
a. Connect the tube between the inlet port and the Unity valve on the
socket.
b. Cut off any excess tube, if necessary.
c. Secure the tube to the prosthesis medially using the tube clamp to
avoid damage during ambulation. Avoid folding the tube and
blocking it (Fig. 5)
4