Össur ICELOCK 544 Instrucciones Para El Uso página 5

ENGLISH
Medical Device
PRODUCT DESCRIPTION
The Icelock 544, referred to as the device in the following document,
®
consists of a variety of component configurations to support the use of
elevated and passive vacuum that help to provide and/or facilitate secure
coupling of the residual limb to the prosthesis specifically in non-weight-
bearing situations, i.e. swing phase during walking.
The different components can be configured as shown in Figure 1 and the
corresponding table. The names of the components are shown in the
following table.
A Socket Adapter
B Seal
C Duckbill valve
D Mesh Filter
E Expulsion Housing
F E2 Connector
G Large Seal
H O-Ring
I Icelock
J Icelock
K Icelock
L Icelock
M LimbLogic Pump Seal
X Housing dummy
1
X Lamination dummy
2
INDICATIONS FOR USE
• Lower limb amputation and/or congenital deficiency
• No known contraindications
INTENDED USE
The device is intended to connect and release a prosthetic system that
replaces a missing lower limb.
The device contains a series of locks systems that can be configured in
different ways, making it compatible with many different suspension
systems.
The device is designed to facilitate suspension of a prosthesis, specifically
by:
• Creating differential air pressure in prosthetic socket;
• Permitting healthcare professional to locate and secure a locking
mechanism into socket during fabrication.
544 Expulsion Plate
®
544 EP Plate
®
544 Reservoir Plate / Icelock
®
544 LL Plate
®
544 Unity Plate
®
5