Happy Soles

Happy TM

Soothing Foot Massage While you lie back and relax Scans your feet for ulcers while you get a stimulating and health promoting foot massage.

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massages your feet and scans for diabetic foot ulcers

*Home Model *Deluxe Model See your local HappySoles tm Dealers.

Available also for rentals for YOUR NEXT FOOT MASSAGE PARTY *Minimum rental of five units. *Professional podiatrist consultation for each of your guests.

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*Complimentary 10 days home unit for new rental contracts

*No more aching feet *Get a soothing foot massage at the end of the day….everyday *No more contorting into a human pretzel looking for foot ulcers

*please consult your podiatrist and/or physician before beginning any long-term usage of this device. *not yet approved by FDA as a diabetic foot ulcer treatment. *Not responsible for injuries caused by misuse or abuse of equipment.

Call 1-800-footmassage to schedule a delivery date Don’t wait…….Call now Operators are standing by

The Harsh Realities of Diabetic Foot Ulcers -“foot amputations from complications of diabetes ... approaching 100,000 annually” Shari Roan March 22, 2009 Los Angeles Times - Foot ulcers account for the largest diabetic related hospital beddays. Reiber (1996)

- Healing a diabetic foot ulcer is very challenging and may lead to the amputation of the foot - Prevention and early detection remains the most cost effective way to address the problems of diabetic foot ulcers

HappySoles

TM

- HappySoles foot ulcers

TM

was designed to address the issue of diabetic

- HappySoles stimulation device

TM

is an early foot ulcer detector and a circulation

The device uses

Scanner/Massager Pod

-Off the shelf technologies and current treatment and detection methods

Massager air outlets

-High resolution digital camera technology to detect skin discolorations -Infrared thermometer to detect temperature differences between the left and right foot

Wide angle Cameras

-Compressed air massager to increase blood circulation to the lower extremities Each Scanner/Massage pod consists of -Two wide angle high resolution digital cameras

Infrared Thermometer

-An infrared thermometer

Massager air outlets

-Three banks of massager air outlets., discharging puffs of warm air

Mounting bracket

Protective Clear Plastic Housing Clear Plastic Housing

HappySoles Operations TM

Scanner/Massage Pods

-The Scanner/Massage pods are arranged in tandem and travels in a synchronous elliptical path around the foot. -The angle of each camera provides overlapping coverage of the foot. as each camera travels along its path -The infrared thermometers are programmed to take readings at six specific sites -The air massager will only be activated after the scanner has completed its scan and no abnormalities are found

Scanner/Massager Pod -Moving Scanner/Massager pods are contained in a protective clear plastic housing -Compressed air outlets are located at various points around the casing to provide warm air to the foot during massage mode

-Eight air outlets/pod provide gentle puffs of warmed air to massage the foot Scanner Path Around foot

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HappySoles Operations Cont’d TM

Electric Drive Motors

Scanner/Massage Pods

Initial Scanner Mode -A healthcare professional conducts a preliminary inspection of the client’s feet to ensure absence of foot ulcers prior to initial scanning -Two initial scans are made of the client’s feet -First scan records the optical map of the feet and baseline temperatures

Foot Support

-Second scan verifies the validity of the first scan and checks the biometric lockout process

Details of Scanner/Massage Pods and Drive Motors Assembly

Biometric Safety lockout for Massager -After the initial scan, The Client is prompted via the User Interface Panel to state his/her name

Scanner Function

-The Second scan tests the robustness of the biometric lockout process

-Discrimination algorithmic software is used to detect differences in pixel contrast from scanned images and/or temperature differences between left and right foot . Abnormal discolorations and elevated temperatures may signal the presence of a foot ulcer

-After the second scan, the User Interface Panel will prompt the Client to re-state his/her name

-When the above readings exceed the normal discrimination threshold, the User Interface Panel displays an alert prompting the client to seek medical attention

-If the voice print and the foot image from the second scan match the stored data and no abnormalities are detected, The Client will be offered a foot massage

-The device is automatically locked for that client.

-The Client’s voice print is paired with his/her digital foot image

-To unlock the device, the client will need to obtain a single use re-set code from a healthcare provider

Massager Operation -if no lesions or temperature differences are detected, the client is offered a foot massage -The Scanner/Massager pods travel the same elliptical path around each foot and circulate warmed air at 0..5 bar pressure to massage each foot

Deluxe Model Currently under development and will be integrated into a state of the art massage chair. Not available for public viewing at this time.

-The air pulses are activated in a set sequence to massage each foot for 15 minutes

Research Support The Use of Air massagers on Diabetic Foot Ulcers

The Use of Infrared Thermometer to Detect Diabetic Foot Ulcers

Mars, 2008 tested compressed air foot massagers on patients with active diabetic foot ulcers.. One bar air pressure (15-20 minutes) 5 days/week.

Armstrong, 2007 and Lavery, 2007, both studies looked at using infrared thermometers to predict the onset of diabetic foot ulcers.

-Conclusion: the foot massage treatment group took significantly less time to heal. -This study demonstrated that using compressed air massagers on diabetic foot is safe -Compressed air foot massage seems to stimulate blood flow to the foot.

-Conclusion: Infrared thermometer was found to be a viable technology in helping to predict onset of foot ulcers

Reference: Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. (2008) Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. American Journal of Medicine. 120(12):1042-6 Lavery, L.A., Higgins, K.R., Lanctot, D.R., Constantinides, G.P., Zamorano, R.G., Athanasiou, K.A., Armstrong, D.G., Agrawal, C.M. (2007). Preventing diabetic foot ulcer recurrence in high-risk patients: use of temperature monitoring as a self-assessment tool. Diabetes Care. (1):14-20. Mars, M., Desai, Y., Gregory, M.A. (2008) Compressed air massage hastens healing of the diabetic foot. Diabetes Technology and Therapeutics. 10(1):39-45. Reiber, G.E. (1996). The epidemiology of diabetic foot problems. Diabetic Medicine. 13(Suppl 1): S6–11. Roan, S. (2009) Trying to save a diabetic feet. Los Angeles Times. Retrieved on April 23,2009 from: http://www.latimes.com/news/nationworld/nation/la-sci-diabetesamputation22-2009mar22,0,5079685.story?page=1

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