Somatx Design KNEEMO01LO Knee Pain Device User Manual

Somatx Design KNEEMO01LO Knee Pain Device

Introduction

Congratulations on purchasing The KneeMo®
The KneeMo® is a device designed to dramatically reduce knee pain and increase mobility for those with Osteoarthritis (OA), knee injuries, or who are from knee surgery.

Safety Precautions & Warnings
The KneeMo® is not is not a substitute for medical advice. Always seek the advice of your personal health care professional with any questions you may have regarding a medical condition.

How The KneeMo® Works

The KneeMo® is not a standard knee brace, but rather a set of motion sensing straps that are placed  above and below the knee. The sensors stimulate the large and small muscle fibers using non-electrical energy. The stimulation interrupts the pain pathway as the brain processes the stimulation instead of the pain, permitting more movement in the knee.  Long-term use can improve knee muscle development, strength, and function. By addressing both pain and muscle atrophy, The KneeMo® can do what other pain solutions cannot. In clinical studies, The  KneeMo® significantly improved knee pain in both the immediate and long term (4 weeks).

Using The KneeMo®

Get to Know your KneeMo®
Your new device consists of an UPPER and LOWER band. Each device has an on/off button, an LED light, a reset button (see image below). Note the upper band has the KneeMo® logo on the front of the unit.
Two neoprene and Velcro straps and a buckle are included to attach the device to the shank and calf USB to USB-c split charging cable to charge The KneeMo® always charge both devices at the same time (INSERT PICTURES)

Wearing The KneeMo®

In order to assure a proper fit, there are several ways to attach your straps to The KneeMo® Thread one side of the neoprene straps through the plastic opening on the device so the side of the strap so the silicone logo is facing the body (Picture). Hold the device in place on your leg and pull the other side of the neoprene strap through the loop and secure snugly around the leg.

• (Placeholder) Threading it so you can use the tri-glide and make the unit smaller
• (Placeholder) Threading it with the tri-glide and a second strap to make it larger.
• (Placeholder) Threading it so you can use the tri-glide and make the unit smaller
• (Placeholder) Threading it with the tri-glide and a second strap to make it larger.

Operating Instructions

Turning on the Device
Once the device is on your leg, make sure your leg is straight so the two units can “talk” to each other.
Press the on/off button on the lower device, the device should buzz and flash blue
Press the on/off button on the upper device, both devices should buzz and flash green, this indicates The KneeMo® is paired and working properly.
LED Sequencing Section
The KneeMo® Application
Specifications (Cleaning, Operating & Storage Temperature, etc.)

Troubleshooting

Devices won’t connect – Ensure your upper band is above your Knee cap and the lower band is below the knee.
Legal & Regulatory
Legal Notices

Trademark and copyrights?
Limited Warranty
THE KNEEMO® HAS A 1-YEAR LIMITED WARRANTY (THE “LIMITED WARRANTY”), GIVES YOU SPECIFIC LEGAL RIGHTS AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE (OR BY COUNTRY OR PROVINCE). THE LIMITED WARRANTY CAN ALSO BE FOUND ONLINE AT WWW.THEKNEMO.COM/WARRANTY, AND IN THE DOCUMENTATION SOMATX DESIGN, INC. (“WE”) PROVIDE WITH THE KNEEMO®.
WE WARRANT THAT DURING THE WARRANTY PERIOD, THE KNEEMO® WILL BE FREE FROM DEFECTS IN MATERIALS AND WORKMANSHIP. OUR RESPONSIBILITY FOR DEFECTS IN MATERIALS AND WORKMANSHIP IN THE KNEEMO® IS LIMITED TO REPAIR OR REPLACEMENT AS DESCRIBED BELOW IN THIS LIMITED WARRANTY.
THIS LIMITED WARRANTY APPLIES ONLY TO THE ORIGINAL CONSUMER PURCHASER DURING THE WARRANTY PERIOD, AND NOT TO ANY SUBSEQUENT PURCHASER, TRANSFEREE OR OWNER OF THE KNEEMO®.
WE LIMIT THE DURATION AND REMEDIES OF ALL IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TO THE DURATION OF THE WARRANTY PERIOD. SOME STATES (OR COUNTRIES OR PROVINCES) DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE FOREGOING LIMITATION MAY NOT APPLY TO YOU.

Who may use the Limited Warranty?
This Limited Warranty is extended only to the original consumer purchaser of The KneeMo® during the Warranty Period, and only to purchases of The KneeMo® from an authorized retailer. This Limited Warranty does not extend to any subsequent purchaser, transferee, or other owner of The KneeMo®, or any purchases made from a retailer other than an authorized retailer. Transfer or resale of The KneeMo® will automatically terminate coverage under this Limited Warranty with respect to that KneeMo®. This Limited Warranty is not transferable to any third party, including but not limited to any subsequent purchaser, transferee, or other owner of The KneeMo®.

What is the Warranty Period?
This Limited Warranty starts on the date of the original retail purchase of The KneeMo® by the original consumer purchaser and lasts for a one-year period from that date (the “Warranty Period”). The Warranty Period is not extended if we repair or replace The KneeMo® under this Limited Warranty or otherwise. We may change the availability of this Limited Warranty at our discretion, but any changes will not be retroactive. Save your proof of purchase to demonstrate the date of your original retail purchase of The KneeMo®.

What does the Limited Warranty cover?
This Limited Warranty covers defects in materials and workmanship of The KneeMo® during the Warranty Period. During the Warranty Period, we will, at our option, repair or replace the defective KneeMo® (or a defective part), free of charge for parts or labor, if it is determined by us, in our sole discretion, to be defective in materials or workmanship. Such repair or replacement of a defective KneeMo® may use refurbished parts of similar quality and functionality. If we elect to repair or replace a KneeMo® under this Limited Warranty, the costs of transportation (including return shipping) of a KneeMo® will be paid by us for shipments within the U.S. and Canada only. Consumers outside of the U.S. and Canada will be required to pay for the costs of transportation (including return shipping). All consumers will be required to pay for the costs of transportation or shipping a KneeMo® to us for inspection and service under this Limited Warranty. If The KneeMo® is determined by us not to be defective in materials or workmanship, you may be responsible for labor charges, and will be responsible for parts, labor and other charges for any repairs.

What does the Limited Warranty not cover?
This Limited Warranty does not cover any damage due to: (a) transportation, (b) storage, (c) improper use, misuse, abuse or neglect, (d) failure to follow The KneeMo® instructions or to perform any preventive maintenance, or damage caused by lack of reasonable care or by connecting The KneeMo® to power and/or data cables that are not supplied by us, (e) modifications, alterations, unauthorized repairs, tampering, or other actions or work not take or performed by us, (f) normal wear and tear, including chips, scratches, abrasions, discoloration or fading, (g) external causes such as accidents, abuse, negligence or other actions or events beyond our reasonable control or beyond normal operation of The KneeMo®, and (h) other damage unrelated to a defect in materials or workmanship. This Limited Warranty does not include USB cords, chargers, power cables, other accessories included with The KneeMo®, or other consumable items.

How do you request inspection and service under the Limited Warranty?

To request inspection and service under this Limited Warranty, contact our Customer Service Department at 1-888-688-0896, during the Warranty Period to obtain a Warranty Return Authorization (“WRA”) number. Our Customer Service Department will require proof of purchase to provide you a WRA number. No return shipments will be accepted, and no warranty services will be provided, without a WRA number. Our Customer Service Department is available to answer questions on this Limited Warranty and can give you detailed instructions on how to return The KneeMo® to us for inspection under this Limited Warranty.

[DISCLAIMER;] LIMITATIONS ON WARRANTIES AND LIABILITIES
TO THE EXTENT NOT PROHIBITED BY LAW, THIS LIMITED WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, ORAL, WRITTEN, STATUTORY, EXPRESS, OR IMPLIED. EXCEPT FOR THE EXPRESS WARRANTIES CONTAINED IN THIS LIMITED WARRANTY AND TO THE EXTENT NOT PROHIBITED BY LAW, WE DISCLAIM ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
SOME STATES DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES, SO THIS DISCLAIMER MAY NOT APPLY TO YOU. TO THE EXTENT SUCH WARRANTIES CAN NOT BE DISCLAIMED UNDER THE LAWS OF YOUR JURISDICTION, WE LIMIT THE DURATION AND REMEDIES OF SUCH WARRANTIES TO THE DURATION OF THE WARRANTY PERIOD.

[WITHOUT LIMITING THE GENERALITY OF THE FOREGOING,]
WE LIMIT THE DURATION AND REMEDIES OF ALL IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TO THE DURATION OF THE WARRANTY PERIOD. SOME STATES (OR COUNTRIES OR PROVINCES) DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE FOREGOING LIMITATION MAY NOT APPLY TO YOU. THE REMEDIES DESCRIBED ABOVE ARE YOUR SOLE AND EXCLUSIVE REMEDIES AND OUR ENTIRE LIABILITY FOR ANY BREACH OF THIS LIMITED WARRANTY. OUR LIABILITY SHALL UNDER NO CIRCUMSTANCES EXCEED THE ACTUAL AMOUNT PAID BY YOU FOR THE DEFECTIVE KNEEMO®, NOR SHALL WE UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES OR LOSSES, WHETHER DIRECT OR INDIRECT, FORESEEABLE OR UNFORESEEABLE, AND WHETHER OR NOT ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR LOSSES, OF ANY NATURE OR KIND WHATSOEVER. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.

[Dispute Resolution]
This Limited Warranty is given by SomaTx Design, Inc., whose address is at PO BOX 361, Zephyr Cove, Nevada, and it gives you specific legal rights. You may have other rights, which vary from state to state or jurisdiction to jurisdiction. For a full understanding of your rights you should consult the laws of your state, country or province. This Limited Warranty is only valid in the U.S. and Canada.

FDA

A review of the Code of Federal Regulations Subchapter Title 21 H-Medical Device, Part 80 Physical Medical Devices, Subpart F Physical Medicine Therapeutic Devices indicates that this device meets similar standards to Sec. 890.5975 Therapeutic Vibrator and is a Class 1 device. The device is exempt from the premarket notification procedures. As such there are no known risks to the subjects beyond those associated with using similar Class 1 devices such as therapeutic vibrators or a soft knee braces.

FCC

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to providereasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.
IC
CAN ICES-3(A)/NMB-3(A)
This device complies with ISED Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

1. This device may not cause interference, and
2. This device must accept any interference, including interference that may cause undesired operation of the device.

References

• theknemo.com/WARRANTY

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