Ossur ICEROSS SEAL-IN X5 Gebrauchsanweisung Seite 4

ENGLISH
Medical Device
DESCRIPTION
The device is a silicone liner that covers the residual limb and provides
an interface between the residual limb and the socket of the prosthesis.
The device forms a suspension system where a distal vacuum chamber is
created below the level of the seal that reliably suspends the residual
limb in the prosthesis.
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
Iceross Seal-In X5 is a transtibial liner.
Iceross Seal-In X5 TF is a transfemoral liner.
The device is for low to extreme impact use, e.g., walking, running, and
sports.
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.
Warning: The device shall not be used by patients with drastic volume
changes within a short period of time, exceeding 3 ply.
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
For a transtibial liner, the correct size is determined by bending the knee
slightly, allowing the soft tissue to hang down.
To determine the correct size:
• Measure the circumference of the residual limb 4 cm from the distal
end (Fig. 1)
• Choose the corresponding device size. If the measurement taken does
not have a corresponding device size, round the measurement down.
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