By:

Dharmesh Doshi (KEU 98009)

Lim Shih Theng (KEU 990055)

Nik Nabil Amin (KEU 990036)

INTRODUCTION

The Ascend Region Air Wave Health Machine by compression therapy system, works effectively in enhancing the circulation of blood and lymph fluid in the blood and lymphatic system. The compression therapy system is highly recommended by the Academy of Lymphatic Studies, United States to prevent accumulation of lymph fluid and for the treatment of Lymphedema. It also enables the blood to flow smoothly in order to provide enough oxygen to the cells.

How It Works?

When the air is pumped into the air bags, the compression therapy starts from the calf and moves slowly to the other parts of the body. The massage is aimed at 5 areas of the body, which enhances the circulation of lymph fluids in the whole body. The main objective of this machine is to stimulate the circulation of blood and lymph fluid to ensure that the supply of nutrients, vitamins, oxygen and various minerals to the body is always sufficient and to maintain the body metabolic rate.

This machine has 5 air bags. The air bags are used to create a 'massage therapy', a holistic procedure that affects all systems of the body; digestive, elimination, respiratory, circulatory, lymphatic, endocrine and nervous system. This aerobic form massage restores and revitalizes the skin, maintains body weight and a shapely figure, regulates the body and mind, relaxes the nervous system, relieves muscle aches and pain after exercising and stimulates organs such as the stomach and intestines. Besides that, it eases the body by reducing nervous tension and calms ones mind.

BRIEF DESCRIPTION OF THE DEVICE

Principle Of Operation

The Air Wave Health Machine works by:

Electromechanical effect:

This effect is by stimulation of the lymphatic and arteriole-venous circulation systems. The electromechanical effect strengthens the blood and lymphatic circulatory system, activates the body cells, and regulates the metabolic rate of the body. As a result, the body will be healthy and free from illness.

Metabolic effect:

In this effect, the cells containing the fat (adipocyte cell) are stimulated to work again and therefore the fatty tissue dissolves. The machine presses on the inner layer of the skin and this increases the circulation of blood, resulting in the transformation of body fats to energy and permits the figure to undergo a spectacular slendering process by:

• reducing the accumulation of fatty tissues on the thighs and abdominal wall
  

• slimming down the hips and the waist
  

• improving the circulation on the lower limbs
  

• toning up the muscles
  

• firming up the skin
  

• eliminating the orange-peel skin

Specifications of the Ascend Region Air Wave Health Machine

Components of the Ascend Region Air Wave Health Machine :

1. The compressor motor
   

2. Arm and calf air bags
   

3. Thigh air bags
   

4. Waist air bags
   

5. Air conveying tubes

Images of the Ascend Air Wave Health Machine:

MAIN ADVANTAGE/BENEFIT CLAIMED BY THE ASCEND AIR WAVE HEALTH MACHINE USAGE

"The Ascend Region Air Wave Health Machine by compression therapy system works effectively in enhancing the lymphatic system flows. The compression therapy system is highly recommended by the Academy of Lymphatic Studies, United States to prevent accumulation of lymph fluid and treatment of Lymphedema." as quoted from the website http://www.geocities.com/aregion/index1.html

Other claims:

• Restores and revitalize skin, maintains body weight and a shapely figure
  

• Regulates body and mind, relaxed nervous tension
  

• Maintains daily exercise volume, for warming up and relieves muscle aches and pains after exercising

Actual facts (According to Medical Science and Clinical Studies):

For Lymphedema:

(Excerpts from References [2] & [3])

Articles about lymphedema are often introduced with the misleading statement that the pathophysiology of the disease is unclear and treatment is unsatisfactory. Yet, the general principles of the pathophysiology of lymphedema are known, although the exact pathogenesis is still open to investigation. In its purest form, the principal disturbance is a low output failure of the lymph circulatory system, that is, overall lymphatic transport is reduced.

Because lymphedema is a chronic generally incurable ailment, it requires, as do other chronic diseases, lifelong care and attention along with psychosocial support as appropriate. The continued need for therapy does not mean a priority that treatment is unsatisfactory, although it may be less than ideal. For example, patients with diabetes mellitus continue to need drugs (insulin) or special diet (low calorie, low sugar) in order to maintain metabolic homeostasis. Similarly, patients with chronic venous insufficiency require a lifelong need for external compression therapy to minimize edema, lipodermatosclerosis and skin ulceration.

Compressive bandages can be harmful and/or useless if applied incorrectly. Accordingly, such bandaging should be carried out only by professionally trained personnel. Massage alone, performed as an isolated technique, classical massage or effleurage usually has minimal benefit. Moreover, if performed overly vigorously, massage may actually injure lymphatic collectors. "Tuyautage" or wringing out performed with bandages or rubber tubes is now regarded as potentially dangerous and thus obsolete.

For Other Claims:

(Excerpts from References [4])

Medical compression techniques are the most effective and affordable way to treat vein problems. There's no surgery involved, no pain and no high medical bills. Although they may look like fashion stockings or support hose, compression stockings are quite different. They are prescribed to prevent swelling, reduce pain and provide comfort, by improving blood circulation.

The compression stockings are designed to help push stretched or damaged veins back into place, helping the valves close properly so veins can carry blood throughout the body with near normal efficiency. "Graduated compression" means the compression is stronger at the bottom of the leg-at the ankles and calves-and steadily decreases in pressure toward the top of the leg. This feature helps counteract the effects of gravity and reduces swelling in the feet and ankles.

HAZARDS & RECOMMENDATIONS

Before we go on further, let us first review the definition of medical device defined by US statute (section 201h of the Food, Drug and Cosmetic Act):

An instrument, apparatus, implement machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or, accessory, which is:

1. recognized in the official National Formulary
   

2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
   

3. intended to affect the structure or any function of the body of man or other animals , and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

It can be seen that this device can be categorize under class 1. Class 1 devices are those that are adequately regulated by general controls. Class 1 device as one for which general controls "are sufficient to provide reasonable assurance of the safety and effectiveness of the device". However, a class 1 device "is not purported or represented to be for use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and does not present a potential unreasonable risk of illnesses or injury."

Nevertheless, a safe device was defined as " the probable benefits from health from uses and conditions of use of the device for its intended uses and conditions of use, when accompanied by adequate directions and warnings against unsafe usage, outweigh any probable risks". The question is, how safe is this device?

One of the most prominent hazard that can occur when using this product is electrical shock. Electric shock may cause an unwanted cellular depolarization and its associated muscular contraction, or it may cause cell vaporization and tissue injury. In general, the physiological effects of current on the body for several seconds range from tingling sensation at 1 to 5mA applied to the surface, to tissue injury due to burns when more than 1 A is applied. A surface current above 5 mA is considered dangerous because it may cause pain or injury. Let-go current (8 to 20 mA) causes involuntary muscle contractions.

It is clear that currents above 5 mA should be considered hazardous. Currents above 20 mA passing through a vital organ can be fatal. The Ascend Region Air Wave Health machine was presented without further information on its safety procedures, especially regarding the electrical shocks. We are sure if the compressor motor is fused so as to prevent unwanted mishaps. Furthermore, although it was a kind of therapy recommended by an obsolete organization, it still lacks the proper approval, maybe not really on its effectiveness but on its safety, particularly by recognized bodies such as FDA.

Though electrical leakage may happen in any electrical device, this does not mean we can tolerate such accident to take place in a device that intends at its first place to give relief and comfort to the body and mind.

The Ascend Air Wave Health Machine should be used only after consulting a family physician or other health care professional. Also, an individual shouldn't treat this machine as the only cure to any health problems faced. If the massage therapy created by the machine is performed overly vigorously, massage may actually injure lymphatic collectors. So, it is best to use only when necessary and at a moderate fashion.

REFERENCES

1. Ascend Region Air Wave Health Machine brochure and web page.
   http://www.geocities.com/aregion/index.html

2. The Diagnosis And Treatment Of Peripheral Lymphedema. Consensus Document of the International Society of Lymphology Executive Committee.
   http://www.u.arizona.edu/~witte/consen.htm

3. Academy Of Lymphatic Studies.
   http://www.acols.com/index.html

4. A Patients guide to Lymphedema.
   http://www.biocompression.com/l1intro.htm

5. Food and Drug Administration Home Page.
   http://www.fda.gov/