• Intended Use Statement: This device is intended for single user, able bodied human under 126kg with need for single lower
limb unloading during walking, without concurrent use of other assistive devices (cane or crutch) in normal indoor and outdoor
environments between 0° C and 40° C.
• Expected Product Lifetime: 150 days at 6000 total steps per day on heaviest user; longer expected for smaller user.
• Cleaning Instructions: Rinse clean with fresh water, then allow to dry, ensuring that no liquid remains.
Device is not intended for unsupervised use by patients with significant balance issues or cognitive difficulties.
Cognitively impaired users must seek assistance from a person qualified to use the device.
Only use device after proper assembly in accordance with instructions by qualified personnel.
If you do not understand these instructions, stop and seek qualified assistance.
Device is intended for use by a single user only, not for rental or resale.
Flammability: This device does not incorporate self-extinguishing or fire retardant materials.
Do not expose to external sources of ambient heat or open flame. Do not store or leave in direct sunlight, and do not use
when painfully hot to the touch until device is allowed to cool.
Do not place fingers or small appendages in or near holes or V-shaped openings, while in use or stationary.
Do not ingest any components of the device. Do not assemble or disassemble in the presence of small children.
Discontinue use if there is any evidence of soft tissue damage associated with use or wearing the device.
Device has no user serviceable parts. Follow original assembly instructions when replacing a part.
Transport in fully assembled and ready for use condition. If returning for service, follow Repackage Instructions.
If product changes performance during use, stop use instantly, & contact authorized distributor for resolution.
Essential Performance Statement: Essential Performance of this device is the ability to bear maximum user load in single limb
standing without harm imparted to the user while allowing the device to be removable by the user who can elect to remain
standing while choosing an alternate method of support.
ce
partner
4U
, Esdoornlaan 13, 3951
DB Maarn, The Netherlands
iWALKFree Inc.
130 North Marina Drive
Long Beach CA 90803 USA
REGULATORY AND COMPLIANCE INFORMATION
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Summary of Contents for iWALK 2.0
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