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iWALK 3.0 - Regulatory and Compliance Information

iWALK 3.0
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Regulatory and Compliance Information
Device is not intended for unsupervised use by patients with signicant balance issues or cognitive diculties.
Cognitively impaired users must seek assistance from a person qualied to use the device.
Only use device after proper assembly in accordance with instructions by qualied personnel.
If you do not understand these instructions, stop and seek qualied 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 re retardant materials.
Do not expose to external sources of ambient heat or open ame. 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 ngers 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 does not respond to verbal or telepathic commands.
Device has no user serviceable parts. Follow original assembly instructions when replacing a part.
Device contains metallic components. DO NOT WEAR OR USE during medical imaging of any kind, including MRI.
cepartner4U , Esdoornlaan 13, 3951
DB Maarn, The Netherlands
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.
iWALKFree Inc.

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