Ossur Icelock 400 Bedienungsanleitung

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ENGLISH
Medical Device
DESCRIPTION
The Icelock 400 for Standard Lamination is
a mechanical lock that offers a smooth
transition and locks in every position. It is
easily interchangeable and removable
from the inside of the socket.
Components (Fig. 1)
1. Pin
2. Funnel
3. Lock Body
4. Release Mechanism
5. Push Button
6. Protective Sleeve
7. Dust Cap
8. Short Mounting Screws
9. Coupling Plate
INTENDED USE
The device is intended to connect and
release a prosthetic system that replaces
a missing lower limb.
The device must be fitted and adjusted
by a healthcare professional.
Suitability of the device for the
prosthesis and the patient must be
evaluated by a healthcare professional.
Indications For Use and Target Patient
Population
• Lower limb amputation and/or
congenital deficiency
• No known contraindications
The device is for high impact use, e.g.,
walking and occasional running.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should
inform the patient about everything in
this document that is required for safe
use of this device.
Warning: If there is a change or loss in
device functionality, or if the device shows
signs of damage or wear hindering its
normal functions, the patient should stop
using the device and contact a healthcare
professional.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
To fabricate the socket it requires:
– Fixture (P-20109)
– Dummy (P20151)
1. Flatten the distal end of plaster cast
and attach the Fixture with two small
nails. The transition from cast to the
Fixture should be smooth. Ensure the
Fixture is mounted in alignment with
the residual limb (Fig. 2).
2. Fabricate a soft liner of 3 mm PeLite
or similar material. Leave the distal
bolt end open (Fig. 3).
3. Mount the bolt to the Fixture (Fig. 4).
4. Apply the Dummy on top of the
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Fixture. Ensure that the bulge for the
push button is orientated correctly
(Fig. 5).
5. Insulate with A PVA-bag and seal at
the top of the Dummy (Fig. 6).
6. Place chosen socket adapter on top
of the Dummy, between the layers of
reinforcement material. Laminate as
usual (Fig. 7).
7. Remove the cured socket from the
cast. Drill carefully to reveal the center
screw in the bulge for the Push
Button. Push the plastic piece into
the Dummy. Remove Dummy from
the socket. Grind a hole for the Push
Button (Fig. 8).
8. Attach the Coupling Plate to the Lock
Body with the Short Mounting
Screws. Then insert the Coupling
Plate and Lock Body into the socket
(Fig. 9).
9. Drill 4x 3 mm holes through the
socket wall into the flange of the
Coupling Plate. Secure the Coupling
Plate to the socket with the Short
Mounting Screws (Fig. 10).
10. Trim push button to desired length
and screw onto the Lock Body
(Fig. 11).
11. Apply the Funnel to the Lock Body
from the inside of the socket (Fig. 12).
Attachment Pin
Apply Loctite 410/411 onto threads of
Attachment Pin Smooth and screw into
the locking liner, torque to 4 Nm with a
7 mm torque wrench.
Caution:
– Do always check that the threaded
adapter for the locking pin is
tightened before the prosthesis is
attached.
– Maximum weight of the
prosthesis: 10 kg.
Caution: Use only Attachment Pin
Smooth. The locking pin should be
exchanged at least once a year.
USAGE
Cleaning and care
Clean with a damp cloth and a mild
soap. Dry with a cloth after cleaning.
Environmental Conditions
The device is Weatherproof.
A Weatherproof device can be used in
a wet or humid environment and can
tolerate being splashed by fresh water (e.
g., rain), no submersion is allowed. No
contact with salt water or chlorinated
water is allowed.
Dry with a cloth after contact with fresh
water or humidity.
Clean with fresh water in case of
accidental exposure to other liquids,
chemicals, sand, dust, or dirt and dry
with a cloth.
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