By:

K. Puvaneswary (KEU 990010)

L. Meelashini (KEU 990026)

INTRODUCTION

Medical devices, products and technologies are converging to revolutionize home and self-care health systems, making it possible for people to play a greater role in maintaining their own health. These systems are geared toward a prevention-oriented, consumer-driven model for health care that includes innovations such as "smart devices" that can "think" for themselves, customized wearable devices, electronic patient records, and wireless Internet-linked systems all expected to deliver convenient, user-friendly, intelligent health care in the home. For consumers, this could mean convenience in time and travel and reduced health-care costs, and it is hoped to result in home-care systems that teach people to monitor themselves with gizmos that give timely warnings of illness so that they can turn to their physicians early when intervention will do the most good. For doctors, it could mean more efficient and effective health care driven by patients who take greater responsibility for their own health. The ability of patients to operate a home use medical device, for example, can depend on medical training and experience, language barriers, literacy, memory, learning ability, dexterity, vision, and hearing. Difficulties using certain devices can be caused by advanced age, medications, or the actual medical condition that requires use of a product.

Although there are many advancement in the technology of home use medical devices, but there are number of questionable medical device and cures currently on the market which are claimed to be beneficial to health, even though there is no scientific or medical evidence to support such claims. Moreover, some devices claiming to use similar technology are also being promoted as effective treatment for almost every other type of ailment, including hypertension, diabetes, arthritis, problems of the liver and kidneys, chronic pain, AIDS, and even various forms of cancer. In fact, because there is no verifiable scientific or medical evidence, these claims are considered to be a misrepresentation of the benefits of the device, and are prohibited under the Food and Drugs Act. Whereas, the focus of most of CDRH's guidances will be on ensuring that users are able to safely operate and maintain the device anything they would need to know about, such as controls, displays, software, labeling, and instructions.

One of the most preferably and widely used as the home use medical device is the Ogawa Sports Double Action Thump Massager, this appliance is designed for domestic use only. Many elderly people as well as sports man believes that this massager are effective in restoring them with good health and well being, without considering the risk or hazard of using the device. Therefore a review was done to seek out the benefits, and as well as the negative effects imposed by the device towards the users.

DESCRIPTION OF THE DEVICE

Ogawa Sports Double Action Thump Massager is a infra red heat treatment product (sports therapy collection) to relieve tension and relax. It has two large massaging nodes, which tap alternately to provide a vigorous massage to stimulate blood circulation and relieve tension from muscles. It can be used to assist treatment of back pain, tension, tennis elbow, sports strains and sprains , damaged ligaments and all muscles related injuries. Infra thumper can also be used for fat removal on abdomen and massaging points for adult disease, such as to recover from fatigue the massaging point would be the left foot sole whereas those who suffer from menopause disorder and liver disease can use the massager to stimulate the sole of foot thus they may be powered up and get rejuvenated. These professional thump massager favored by a majority of chiropractors, massage therapists, physical therapists across the country, many professional athletes, entertainers, and it is the choice of sports rehabilitation therapists.

Special Features

The special features of the device are as follows:

• Extra long angle handle plus adjustment.

• Twist-head with infrared heat/deep soothing massage selections.

• Flexible neck design to "HUG" all body contour.

• Four custom attachments for your whole body massage.

• Four-position switch with pilot light indication.

• High valued motor has excellent therapy effect and superior durability.

• Tapping power control by high or low.

• Ergonomic design is possible to use any body.

• Infrared lamp inside / sauna effect .Get the sauna effect during operate it and the surface
  ��� temperature go up to 70�C.

• Superior iron effect for beauty care.

Unit Specifications

• Power supply : A/C 220V, 50Hz

• Cord Length : 2 m

• Power consumption : 30W

• Vibration : 2,300-3,000/min

• Noise : Below 60 � dB

• Size : 146 X 120 X 400 (W X H X L)

• Weight: 1,250g

• Operating conditions: 10�C~40�C , 40%~90% r.H.

• Conditions for Storage/ Transportation: -10�C~60�C, 30%~95% r.H

Instructions For Use:

Ogawa Sports Double Action Thump Massager can be used as followings:

1. The main plug should be put into the socket.

2. The switch is used to adjust the intensity of the massage.

3. The switch can slide to low for lower intensity massage and high for higher intensity massage.

4. The infra red lamp button is pressed to switch "on" the infra red lamp and add heat to massage, and just need to press it again to switch it "off".

5. After use, the massaging switch need to turn off position, then the plug can be remove from the mains.

Maintenance of Device

The user can do maintenance of the massager since the procedures are easy to follow. To clean, unplug the unit and wipe with a damp cloth, which is not very wet. The cloth needs to be squeezed properly to ensure no excessive water in it. Do not immerse in water or let water contact to get inside the massager. After cleaning, only use the device when it is completely dry. Periodically straighten the cord if it becomes twisted. After use and cleaning procedures, this product should be stored out of the way in a cool, dry place.

Advantages

Ogawa Infra Thumper is smaller, lighter and designed specifically for self-application. It is for use on both thick and thin muscles. It is fully adjustable to the person or body part user wish to thump. User feels thumper massages throughout his body, not just on the skin surface. Two anatomically designed massage spheres rubberized nodes produce deep penetrating waves to release tension and knots. It is a professional-strength massager in a personal, self-use size, perfect for packing and travel.

EVIDENCE (OR LACK OF) SCIENCTIFIC PRINCIPLES

This device uses the principle of infrared heat treatment to provide pleasant and comfortable massage to its user. Sliding the massager switch to either high or low intensity can easily control the intensity of infrared. Meanwhile, it also uses magnetic field as its therapy during massage. The scientific principles of Ogawa Infra Thumper are clearly applied during its operation mode and as well as during its method of therapy as explained below:

Maintenance of Device

Twin Silicon Massage Ball The principal, twin hardball directly taps alternately in vertical 38 to 50 times in a second, raises the penetration effect. Without any special force, user uses it comfortably and feels sufficient massage effect from its own weight.

Infrared Infrared deeply penetrates into skin about 4-5 mm to induct the cell molecular activity by itself and generates heat to assist in increasing blood circulation, exhaust the waste material and subcutaneous fat combustion.

Magnet The 2,000 Gauss magnet is beneficial for body and tapping by turns increase oxygen capacity, red cell in blood and also accelerates blood circulation.

Infrared Heat Treatment Principles

The Ogawa Infra Thumper uses true infrared lamp that can produce infra red light when the button is pressed to switch "on". This light then penetrates deep into the skin; therefore the skin will be heated. As the skin gets heated, the blood vessels will be dilated and the flow of blood is stimulated. The blood brings with it the substances for rebuilding and nourishing the body tissues more rapidly whereas decomposition products are more quickly removed. The pores in the skin will also be further opened under the influence of the heat. These properties make the infrared light extremely suitable for massaging and therapeutic application. In the cosmetic applications, creams or other skin care agents are better absorbed under the influence of infrared light, and are therefore most effective. The infrared heat will also help to keep the skin healthy and clean, because or its stimulating effect on the blood circulation.

Method of Therapy

Ogawa Infra Thumper uses the concept that, there is circulating route of energy exist in human body, thus needed for harmonizing and normal functioning of all of the internal organs (liver, heart, spleen, heart, kidney, gall, small intestine, stomach, large intestine, urinary bladder). Therefore, by stimulating certain points of such route on the skin, which are connected to each organ mentioned earlier, the effect of therapy for symptoms and diseases can be achieved. Circulation may stop at points where in case of having some trouble in the body. Therapies using such points are finger-pressure, massaging, acupuncturing, maxacautery and far infrared ray magnetic and heat steaming is most effective therapy. When we stimulate the points on the circulating route, stimulation is delivered to the organs via circulating route, to have the effect to improve the functioning of the body. For example, we can get the effect if we press the back of hand for tooth pain, top of head for hemorrhoids, foot for stomach problem. This is called, 'Remote-Control Therapy', which is most recommendable in finger-pressure and massaging. In the basic therapy of finger-pressure, pressing each two points on the shoulder, spine and foot sole is the most important therapy. Circulating of nerves and blood will be improved and may have to be effected to prevent various diseases caused by unharmony of nerve and blood circulation system. By increasing blood circulation to tense areas of speeding lymph flow to carry off lactic acid, Thumper's massage freshens and "oils" tired muscles, quickens their return to suppleness and overcomes fatigue.

POTENTIAL HAZARDS TO THE USER

This product has been used widely and many believe it will restore them to good health and well-being. On the other hand, the manufacturer has claimed safeties and effectiveness of the product. Although it has been claimed or promised but it still can be hazardous to the user if any malfunction occurs and even may cause indirect hazard to the user.

Infra Thumper operates with power supply of A/C 220V, 50Hz , it would be hazardous if any malfunction or internal damage occurs to this appliance. Moreover the risk of leakage current from a faulty massager to the user during application (in use) should take into consideration. Certain amount of leakage current to the user may cause serious injury and electric shock.. There are possibility of leakage current to flow even from a damaged power cord or faulty plug of this appliance that causes electric shock and injuries.

Everyone's body and skin reacts to heat and massage differently therefore the amount of massage time, pressure and heat preferred will vary with individuals and body location. It also depends on the age range of the user, their sex, health condition and their daily activities, which will ensure how healthy they are. There are cases where, when the massager was applied directly on just one area of the body for an extended period of time may be about 15-20 minutes at a time it has caused risk of skin burns, fire and injury to the user. It would be quite hazardous to elderly people, children and disabled people since exposure to the concentrated heat from massager is possible. So, the massager is to be used in a continuous motion, which means the massage areas need to be constantly changed. There are possibility where elderly people tends to dose off during the comfort and pleasant feel of massage, it would be very hazardous and may cause to serious burn and injury to their skin. It would be even worse if they operate the massager under blanket or pillow, where excessive heat from the infrared may cause fire and injury.

It is always safe to massage in the direction of user's heart. Normally, one should massage up the legs and arms to stimulate the blood flow towards the heart rather than away from the heart. If the user massage in the opposite direction, this can cause the heart to function improperly and interrupt the flow of normal blood circulation. This can pose an indirect hazard, if the particular user delays in seeking for proper medical treatment.

Although Infra Thumper have been used widely by many people now a days, but there are people who should not use this massager as it could lead them to more serious health condition. This massager should not be used by patients with pacemakers, artificial joints, pregnancy, tuberculosis, benign and malignant tumors, hemorrhages, inflation to the skin, phlebitis and thrombosis, strombosis, open wounds, bruises, broken skin or varicose veins and undetermined calf pain. The device cannot be used over swollen or inflamed areas, the abdomen when pain is present, on or near the carotid artery on the left or right side of the neck and at anaesthetized area. Heat produced by massager to benign and malignant tumors or may be to an open wound can worsen a patient's condition where the patient might suffer of greater pain and irritation.

If this appliance is left unattended when plugged in, it can increase the risk of burns, fire, electric shock or injury to person that uses the device. The Infra Thumper should not be used while bathing on in the shower. It cannot be placed or stored where it can fall or be pulled into water. Moreover, the tool should not drop into water and other liquids. This is because, water is electricity conductor and once it enters into the device, its casing will allow a small amount of current to flow, which can endanger the user who touches it, especially when lighting occurs. Electric shock can also happen if use the Infra Thumper massager on a wet surface or moist condition.

It is advisable not to use this appliance if it has a damaged power cord or plug which will allow excessive current to flow within the equipment rather than its normal value of 0.136A. On the other hand, the cord should be kept far away from the heated surfaces. When it is placed at a hot temperature environment, then the possibility is high for the massager cord to be bent and the rubberized massaging nodes can lost its original shape. If this occurs, the tapping process in the massage will be improper and the heated surfaces can cause serious burns. This Thump massager device is designed for domestic use only and not outdoor.

RECOMMENDATION OF USE

As have discussed earlier, the Ogawa Infra Thumper could be hazardous to the users if any malfunction occurs as the device operates under power supply and uses heat therapy treatment. Realizing to the possible hazards, (which could not be denied) the manufacturer have highlighted few important safeguard and basic precautions for the user to follow.

The user manual of this device has stated all the necessary direction for its use, appropriate condition during usage, and instructions of should and should not do with the device. Therefore with the clearly stated regulations in the user manual, the user could be able to reduce the risk of potential hazards during operation of Infra Thumper. Some basic precautions needed to follow by the user are such as, should never leave the appliance unattended when plugged in, must not pull the power cord only, never use while sleeping, should not use on eyes or other sensitive areas, do not reach for the appliance that has fallen into water but immediately unplug it, not to be operated where aerosol products are being used or where oxygen is being administered and this device is not suitable to use when driving a car or in operating the dynamic electron-mechanical equipment.

Since the user manual has the necessary information needed for optimal operation of the massager, therefore it is recommended that the user should read all the instructions before using it. Moreover, it would also reduce the risk of potential hazards to the user. It is recommended that, close supervision is necessary when this appliance is used by elderly people, invalids, disabled persons or near children since these category of people are more likely exposed to the direct concentrated heat from massager.

Although the massager provides pleasant and comfortable feeling, but always the user should consult the doctor if they have any questions regarding the use of this massager. It is advisable that this massager should not be used by persons under the care of a physician without first consulting the physician, and for treatment of pain control, muscle injuries or rehabilitation, this device should be used under close supervision and direction of the professional therapist.

However, there are many cases where elderly people use the massager experiences comfort and less pain as they stimulate certain massaging points at body every day. The vibrating massagers used in a continuous motion, constantly changing the massage area are able to reduce the pain experienced by elderly people. Meanwhile, active sportmen have also manage to relieve from muscle tension, sports strain, sprains and all muscle related injuries after using the Infra Thumper massager (continuous usage). Therefore, it can be agreed that the massager does provide good health and pain free, thus it is best recommended that this massager should be used for its intended uses as described in the manual and should never use attachments not recommended by the manufacturer to avoid any hazardous event to occur.

Besides the precautious and safe guard instruction, the manufacturers have taken measures to reduce the risk of electric shock. If any malfunction occurs then the protect cover of the massager will operate, as this device has double safety function by bimetal and fuse. This safety features will reduce the amount of leakage current to flow from a faulty massager.

CLINICAL CASE STUDIES

This professional thump massager has been used by various categories of people across the country for treatment purposes. Following are few clinical case studies of the Ogawa Infra Thumper used by the users.

Case Study 1
A 51 year old male executive officer of a big company with many complaints: Very stressful life, with pain at neck, back, nervous legs, low back pain, hypertension, Very poor sleep even with sleeping pills. His main treatment goals were relieving stress, which we thought is the main cause of other complains. His treatments included Ogawa Infra Thumper and nutritional supplements. Ogawa Infra Thumper was applied over back of neck, low back, low belly, acupuncture points --insomnia 1 and 2. And pain areas. Changes noted after first treatment: pain reduced. He purchased the Ogawa Infra Thumper to use at home. He reported that he could not live without the massager to reduce his stress and pain. He slept much well than before, since using the massager every day.

Case Study 2
A 69-year-old female with multiple complaints: arthritis in knees, neck, back. nervous legs, colitis, low back pain, hypertension, right rotator cuff and other muscle pain. Her main treatment goals were relieving the joint aches and lower back pain. Her treatments included acupuncture, nutritional supplements, and Ogawa Infra Thumper. The massager is applied to the points on the shoulder, spine and foot sole. Changes noted after first treatment. Right shoulder felt better, better digestion and bowel functions. She felt the massager was effective enough to purchase one to use at home. She reports continued improvement between treatments by treating herself with infra red therapy at home.

Case Study 3
A 25 years old football athlete was suffering from muscle tension, sports strain, sprains and all muscle related injuries. His primary treatment was self-treatment with the Ogawa Infra Thumper and he managed to relieve from the pain, after continuous use of the massager. He reports that the vibrating massager used in a continuous motion, constantly changing the massage area is able to reduce his muscle tension and sprains. Now, he is able to increase his performance quite effectively without any complaint.

Case Study 4
A chronic fatigue patient for as long as she can remember this 45-year-old female has gotten marked relief through acupuncture, nutritional supplementation, and Ogawa Infra Thumper treatments. She, too, has the massager at home and uses it daily. She states that she would not be without her Ogawa Infra Thumper. Infrared therapy has pulled her through many a tough day when her energy level bottomed out. She is able to maintain her mental clarity better during bouts with energy loss and maintain normal sleep that she was not able to even with sleeping pills, and she is able to be up and around more hours a day. She recovers more easily from her episodes of energy loss. Her emotional stability is greater because she knows she has immediate help available with the massager. Over the past year and a half of weekly treatments, her overall condition has improved considerably, and her improvement has been noticed by herself, her family and friends, and her practitioner.

CONCLUSION

The Ogawa Infra Thumper is a technological breakthrough in the history of massage made possible through research and development in the field of healthy living. Its innovative design combining the dynamic usage of infrared heat, applied pressure and 3-dimentional vibration system has revolutionize the art and convenience of a massage with optimum results made in the comfort of users own home. With effect on improved blood circulation, metabolic rate, immunity, balance of the nervous system, burning of fats and the enhancement of the 5 entrails and 6 viscera performance could lessen problems of high blood pressure, arteriosclerosis, gout, diabetes, fatness, insomnia, constipation and headache. A daily usage of this sports double action thump massager for a maximum of 10-15 minutes at a time ensures the user to achieve more leisure and healthy lifestyle. Even though the home use device has potential hazard to the users, it can be used safely if the user take in account all the warnings and precaution mentioned by the manufacturer. The most important thing that need to be considered is to use the Ogawa Infra Thumper in a proper environment as recommended in the manual and apply appropriate procedures with correct techniques while operating it.

REFERENCES

User manual: Ogawa Sports Double Action Thump Massager Model No: MW2020

http://www.ogawa.com