INTENDED USE
The device is intended to connect and release a prosthetic 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
• None known contraindications
The device is for high impact use, e.g., walking and occasional running.
The weight limit for the device is 166 kg.
GENERAL SAFETY INFORMATION
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.
REQUIRED COMPONENTS
Use in combination with an Iceross
Seal-In X Seal and airtight socket. Please refer to the Instructions for Use
supplied with Iceross
X Seals.
®
Seal-In X Locking liner and Iceross
®
Seal-In X Locking liner, Iceross
®
Seal-In
®
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