Happy TM

massages your feet

and
scans for diabetic foot ulcers

Soothing Foot Massage

Order now
While you lie back and relax
*Home Model
Scans your feet for ulcers *Deluxe Model
See your local HappySoles tm
while you get a stimulating Dealers.

and health promoting foot

Available also for rentals for YOUR
NEXT FOOT MASSAGE PARTY
massage.
*Minimum rental of five units.

*Professional podiatrist consultation

for each of your guests.
Imagine *Complimentary 10 days home unit
for new rental contracts
*No more aching feet

*Get a soothing foot

massage at the end Call
of the day….everyday 1-800-footmassage
to schedule a delivery
*No more contorting date
into a human pretzel
looking for foot ulcers Don’t wait…….Call now
Operators are standing by

*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.
 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
HappySoles TM

- Prevention and early detection remains the most cost effective way to address
the problems of diabetic foot ulcers
- HappySoles TM was designed to address the issue of diabetic
foot ulcers

- HappySoles TM is an early foot ulcer detector and a circulation

stimulation device

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

-Compressed air massager to increase blood circulation to the lower

Wide angle extremities
Cameras
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 tan-

dem and travels in a synchronous elliptical path
around the foot.

-The angle of each camera provides overlapping Scanner/Massager Pod

coverage of the foot. as each camera travels
along its path
-Moving Scanner/Massager pods are con-
tained in a protective clear plastic housing
-The infrared thermometers are programmed to
take readings at six specific sites
-Compressed air outlets are located at vari-
ous points around the casing to provide warm
-The air massager will only be activated after
air to the foot during massage mode
the scanner has completed its scan and no abnor-
malities are found

-Eight air outlets/pod provide gentle puffs of

warmed air to massage the foot

Scanner Path Around foot

Happy
 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 tempera- Foot Support
tures

-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 Inter-
face Panel to state his/her name Scanner Function

-The Client’s voice print is paired with his/her digital foot image -Discrimination algorithmic software is used to detect differences in pixel con-
trast from scanned images and/or temperature differences between left and right
-The Second scan tests the robustness of the biometric lockout foot . Abnormal discolorations and elevated temperatures may signal the pres-
process ence of a foot ulcer

-After the second scan, the User Interface Panel will prompt the -When the above readings exceed the normal discrimination threshold, the User
Client to re-state his/her name 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 device is automatically locked for that client.
the stored data and no abnormalities are detected, The Client will
be offered a foot massage -To unlock the device, the client will need to obtain a single use re-set code from
a healthcare provider

Massager Operation
Deluxe Model
Currently under development and will be
-if no lesions or temperature differences are detected, the client is offered a foot massage
integrated into a state of the art massage
chair. Not available for public viewing at
-The Scanner/Massager pods travel the same elliptical path around each foot and circulate warmed
this time.
air at 0..5 bar pressure to massage each foot

-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 Armstrong, 2007 and Lavery, 2007, both studies looked at using
foot ulcers.. One bar air pressure (15-20 minutes) 5 days/week. infrared thermometers to predict the onset of diabetic foot ulcers.

-Conclusion: the foot massage treatment group took significantly less time to heal. -Conclusion: Infrared thermometer was found to be a viable technology
-This study demonstrated that using compressed air massagers on diabetic foot is safe in helping to predict onset of foot ulcers
-Compressed air foot massage seems to stimulate blood flow to the foot.

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-diabetes-
amputation22-2009mar22,0,5079685.story?page=1

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