Ossur ICEROSS SLEEVE Bedienungsanleitung Seite 4

ENGLISH
Medical Device
DESCRIPTION
The device is a sleeve intended to be used as a suspension mechanism
for Össur cushion liners.
INTENDED USE
The device is a prosthetic interface with suspension properties intended
to be used as part of a system that replaces a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb amputation and/or congenital deficiency
• No known contraindications
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.
Warning: Misuse of the device may result in loss of suspension.
Caution: Potential side-effects are skin irritation/reaction problems.
Caution: The device must not come in contact with glass, carbon fibers,
or other foreign particles. Washing alone may not be sufficient to
eliminate the problem. If the device is exposed to foreign substances or
chemicals, it should be returned to the healthcare professional.
The device is for single patient use.
DEVICE SELECTION
To determine the correct size:
Measure the circumference of the residual limb 15 cm above mid-patella
(Fig. 1) and choose the corresponding device size. See the sizing
chart below.
Size
35
41
49
55
62
FITTING INSTRUCTIONS
Trimming Instructions
The device may be trimmed at either end to improve the fit to the
residual limb and/or the prosthetic socket.
Caution: When cutting the device, ensure a clean cut is made. Any sharp
edges or notches can lead to tears in the material and/or skin irritation.
Measurement (cm)
35-41 cm
41-49 cm
49-55 cm
55-62 cm
62-76 cm
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