DIGITAL IONTOPHORESIS

Iontophoresis is a needle free, non invasive technology for delivering water soluble, ionic drugs or other compounds through the skin using a microprocessor controlled electrical current. The current carries the compounds into underlying tissue and into the blood stream, making the delivery either site specific or systemic. The microprocessor facilitates variable dose control enabling programmable or patient controlled dosing as well as rapid onset and cessation of delivery, where desired. Defining Hyperhidrosis : Sweating is necessary to control body temperature during times of exercise and warm/hot surroundings. Sweating is regulated by the sympathetic nervous system. In 0.6 to /1.0% of the population, this system is revved - up and works at a very high level causing sweating to occur at inappropriate times in specific areas of the body. This condition is known as hyperhidrosis. Classification - causes of hyperhidrosis can be primary or secondary. Regions of the body - scalp, facial ( face ), palmar ( hands ), axillary ( armpits ), truncal ( trunk ), plantar ( feet ). Primary or idiopathic hyperhidrosis - Hyperhidrosis without a known cause. A more frequent condition than secondary hyperhidrosis. Localized commonly in the hands, armpits, scalp, face, and or feet. Starts during childhood or early adolesence, worsens during puberty and then persists for the rest of ones life. Nervousness and psychiatric disorders are rarely the cause. The excessive sweating is very embarrassing and social, professional, and intimate relationships are often seriously affected. Secondary hyperhidrosis - Caused by an underlying condition. Usually causes excess sweating of the entire body, however. Some of these conditions are : endocrine disorders such as hyperthyroidism, endocrine treatment for malignant disease, menopause, obesity, psychiatric disorders, systemic malignant disease.

Manifestations of Primary Hyperhidrosis. PALMAR HYPERHIDROSIS ( HANDS ) Far and above the area of the body causing the most distressing condition. The hands are used socially and professionally more than any other part of the body. Excessively wet/moist hands may even limit the choice of ones profession. Avoiding social contact is common for individuals with severe hyperhidrosis palmaris. Patients notice not only that their hands feel very moist/wet all the time, but also feel cool/cold. Some individuals have a bluish / purple discoloration of their hands as well.

AXILLARY HYPERHIDROSIS ( ARMPITS ) Hyperhidrosis of the armpits causes large wet marks and staining on the clothes. A strong body odor develops quickly which can cause very negative emotional / psychological repercussions. Slightly more common in females than males. The highest incidence occurs with people of Asian and Jewish ancestry, but can affect all races.

SCALP / FACIAL HYPERHIDROSIS AND BLUSHING. Excessive sweating of the scalp and face. Commonly associated with moderate to severe facial blushing as well. This condition often causes the individual to become self- conscious and to develop a low self esteem.

PLANTAR HYPERHIDROSIS.( FEET ) Excessive sweating of the feet. Can be associated with hyperhidrosis of other areas of the body.

TRUNCAL AND / OR THIGH HYPERHIDROSIS . ( TRUNK ) Less frequent. Can be associated with hyperhidrosis of other areas of the body.Characteristics Either sudden onset or continuous sweating. Sweating usually brought on by no apparent reason. Usually not aggravated by exercise. Emotional stress, high ambient temperatures, and /or gustatory stimuli are the mos2t important aggravating factors. Hyperhidrosis usually improves during the cold /cool months and worsens during hot / warm months. Sweating usually stops during sleep. Hereditary ( 25% of individuals with hyperhidrosis tend to have a family member with symptoms as well.)

TREATMENT- Secondary hyperhidrosis is treated by first addressing the underlying disorder. If a patient is on hormonal therapy then administration of an anti estrogen ( ciproterone acetate ) can give relief to sweat attacks. Primary hyperhidrosis patients and secondary hyperhidrosis patients experiencing moderate to severe sweating not relieved otherwise may benefit from the Iontophoresis.

IONTOPHORESIS - Tried, if antiperspirants not effective. Used to treat palmar, axillary and plantar hyperhidrosis. Low intensity electric current ( 0 to 14 mA ) applied to the palms and or soles immersed in an electrolyte solution. Has to be repeated regularly, initially in 20 minute sessions several times / week, gradually stretching out the interval between treatments to 1-2 weeks. The results vary; many patients (70%) suffering from light to moderate hyperhiderosis, are happy with the method, some may consider it too time-consuming or inefficient and comparably expensive, it is difficult to apply in axillary, and impossible to use in diffuse hyperhidrosis of the face or the trunk/thigh region. Side effects include: burning electric shock, discomfort, tingling, skin irritation ( erythema and vesicle formation). Sweating returns after cessation.

Iontophoresis Treatments for Hand and Foot Sweating

Iontophoresis is a treatment that hyperhidrosis sufferers turn to when prescription strength deodorants fail to relieve the sweating. It has a very successful track record (nearly an 83% success rate) according to the American Academy of Dermatology. Keep in mind that this treatment is targetted mainly towards hand (palmar) and foot (plantar) hyperhidrosis so it's not a very effective solution to heavy armpit sweating. However, it will mitigate the two former conditions (plantar and palmar hyperhidrosis) with great results. The process is fairly simple but requires an Iontophoresis device or visiting a treatment center. Both options have a high price tag.

How does Iontophoresis Work? Iontophoresis starts out with your hands or feet or both placed into two open trays. The trays are then filled with water. The Iontophoresis device conducts mild electrical currents through water while your hands or feet are immersed in the trays. The patient will sit with their hands or/and feet submerged in the water filled trays for 20-45 minutes. Occasionally, for more extreme cases of hyperhidrosis, medication will be dissolved in the water to make the treatment more effective. Although the exact formula for success is not understood, it is believed that the mineral particles in the water work together to microscopically thicken the outer layer of the skin. This blocks the flow of sweat from reaching the skin's surface. When this "blockage" occurs, the sweat glands respond by suddenly ending their hyperactivity in effect stopping your spontaneous sweating. There are plenty of warnings that come along with this treatment and pregnant women, people with heart conditions, pacemakers or epilepsy should stay away. Irritation may occur on the skin that is exposed at the water line. A nice trick to avoid this is applying Vaseline to this exposed area. Don't freak out when the treatment starts. You'll feel a very slight charge in the water and you may get startled. Just stay calm and know that you can't be hurt by the electric pulse. It's important that you use Iontophoresis with a qualified and experienced technician. I don't recommend you go out and spend thousands of dollars on this device if you've never had treatment before. Take some trial runs at a treatment center and decide if this is the method you'd like to use incontrolling your hyperhidrosis.

Iontophoresis treatment schedule

The actual treatment involves passing a current one way for a fixed time (polarity 1) and then reversing the current (polarity 2) for the same amount of time. The time of treatment varies from 20-40 minutes depending on whether you are treating the axillae (underarms), hands, hands and feet or feet only (see the table below). It is important that the treatment protocol is followed for the first phase of treatment. The first month involves seven treatments as follows: Day 1, day 2, day 4, day 7, day 10, day 15 & day 22. Please note that treatment will still work if you cannot make a session on the exact day but can have a treatment close to the scheduled day. After this initial phase it is recommended that a single maintenance treatment is performed as soon as the hands, feet or axillae become clammy and before sweating starts again. The frequency of the maintenance treatment varies with the individual and may be anything from twice a week to a month or so. You should continue this maintenance treatment as required. *Please note the machine will only work when the circuit is completed by placing the hands and/or feet in the water baths or the wet axillae pads are applied firmly in place.

Iontophoresis treatment times

Length of treatment times Extremities to be treated Hands only Feet only 1 hand and 1 foot Both hands and feet 20 mins 30 mins 20 mins each side 20 mins Total

WARNINGS 1. The simultaneous connection of this machine with high frequency electrical equipment may result in burns at the point of contact with the electrodes and may also cause damage to the machine 2. Although the machine is electromagnetically compatible, we recommend that you do not use it in the immediate proximity (within 1 metre) of appliances that could generate significant electromagnetic fields or generate short waves, such as your TV, monitor or microwave 3. Only use the accessories recommended for use with the KMS as other accessories may cause damage to the machine 4. Do not allow liquids to get into the cabinet 5. Do not dismantle your machine as there are no serviceable parts and only a qualified technician should do this 6. Do not remove hands and/or feet from baths during treatment as this will cause an unpleasant, but not dangerous, electrical surge 7. Ensure that when handling the charger your hands are not wet.

Treatment of Children The treatment for hands and feet is the same as detailed later in this manual, but because the skin is thinner, the current level should not exceed 15 mA. Please seek medical advice before commencing treatment on children. In addition we advise the presence of an adult during the treatment and ensure the child has an understanding of what to expect during the treatment. For the axillae we do not recommend treating under the age of 16.

INFORMATION FOR PATIENTS AND MEDICAL STAFF

Frequently asked questions
Q Why not design an Iontophoresis machines with automatic polarity? A Because the results are not as good. Sufferers of hyperhidrosis tolerate the passage of Iontophoresis current differently. Our protocol recommends 2, 10 or 15 minute phases. During the 1st phase, the current tolerated may only be a few milliamps, while for others it may be the maximum intensity. During the 2nd phase, the intensity applied will not necessarily be the same. It must be possible to make adjustments at any time to avoid pain or burning. An automatic system will never be able to deliver these adjustments Some people will have strong and sometimes unpleasant sensations at low current levels, while others will feel virtually nothing. What is important is the quantity of the current passing. For an adult, an ideal treatment current should be between 15 and 20mA, but this is not tolerable by many and good results can still be obtained at much lower current levels. Q Is it risky to exceed the recommended treatment time? A No. There is no major risk and it can, on occasions be advantageous to increase the treatment time in stubborn cases. 20 minutes of treatment time is the average guide and we recommend that you do this initially.

Q I have had an operation which has left me with metal components in my body. Is this a contra-indication? A If the metal component in not in the currents path, it is not a contraindication. For example, if you have a hip prosthesis and you only treat the hands, the current path does not involve the prosthesis. However, if you treat the feet, it would be a contra- indication.

Q When I am undergoing treatment, I hardly feel anything; yet the indicator shows that the circuit is complete, is this normal? A The perception of current flow is highly variable from one person to another. Some people will have a strong and unpleasant sensation at a Dear sir,

Q When should maintenance sessions be carried out? A Once the original treatment protocol has been completed, we recommend that maintenance sessions be carried out as and when necessary. However, it is important to carry out another session just as soon as the sweating starts to return and not to wait until full hyperhidrosis is present again. If it has been left too long and full sweating has returned, we recommend that you wait for at least a month after the last session and then carry out the full treatment protocol of 7 sessions over a 4 week period again. Q I have been treating myself for several years and everything was fine. But for some reason the treatment is not as effective as it was. A You cannot become resistant to this treatment. However, if a maintenance session is carried out too late, it will not be as effective. Please see previous point. Q How much water should I put in the trays? A The water only serves to conduct the current and it is not advisable to put in too much water. We recommend 250mls to each hand bath and 500mls to each foot bath, or just enough to cover the area of sweating. Q When I do a treatment my skin goes red above the water level. Am I risking burns? A This redness is due to the vasodilation of the skin blood vessels. It is quite common and is of no consequence.

Q If I press the button on my Iontophoresis machine and the current does not increase, what is happening? A The intensity does not increase on the indicator if the electrical circuit is not Complete Check that all leads are properly connected and that you are in the

correct treatment position.

OPERATING INSTRUCTION FOR THE TREATMENT

When a treatment is to be administered each electrode is placed in a Plastic tray containing enough water to just cover the palms and soles. To switch ON the equipment, an ON/OFF switch is provided . When the switch is ON the Digital Amp, meter displays oooomA. Timer displays 00 ( min ) indicates that the operation is not started.

NOTE : At each starting position of the treatment, the reset button has to be pressed, making the timer at oo position before starting the operation. The Patients hands or feets are placed in the plastic tray after any nicks or scratches have been covered by a little petroleum jelly. Set the required time period for the treatment, by using timer switch provided on the front panel. And press start and the unit will start. Press the push button switch to select Forward and Reverse current. The led will indicate Red for Forward and Green for Reverse . Most patients can readily tolerate current for 10 to 15 minutes. To start the operation turn the potentiometer in anti-clockwise direction, and then turn the potentiometer in clockwise direction slowly and the current begins to flow and this is so increased, until the patient feels some discomfort. Then the current is slightly reduced, the permitted flow of current is from 4 to 14mA.

Current changes are always made slowly to avoid discomfort to the Patient. The amount of current flow can be visualized in the Digital current meter. Too much current or prolong time period taken for the treatment can produce vesculation, if this happens a lower current setting or a shorter time period for the treatment could be used.

1. As we had already set the time period for the treatment, (10 15 mins ) the equipment will start to count down the time and finally will reach to ( 0 min ) and the unit will stop automatic. At this time the current meter shows 0000mA. Some reading may be present but it is negligible. Now the patient can remove his hands or feets and take a break.

In this way each side is subjected to the action of the anodal current for half of the total treatment time and the Patient can remove his hands or feet. Two or three treatments a week for about 2 weeks will usually induce an eudrotic state, which can be maintained by treatment at the intervals of one month or six months or longer.

DIGITAL GALVANIC /IONTOPHORESIS SPECIFICATIONS. Making yourself familiar to the controls of the machine. ON / OFF SWITCH CHANGE OVER SWITCH - Allows you to start the machine by switching the switch. - This switch allows you to select +ve and -ve current by switching the switch.

CURRENT ADJUST - The level of each frequency can be set by current adjust SWITCH ment knob. The frequency level can be set from min to max as per patients filling. TIMER RANGE CURRENT METER OSCILLATOR - You can set the time period of operation from 1minute to 99 minutes. - 4 Digit 7 Segment 0.3 Red Display. - Crystal oscillator.

TIMER SETTING * Press the Stop Switch for 1 sec Beep Sound will come and first digit will start blinking. * Set the first digit with switch. * Press the switch to change the mode and the second digit will start blinking. * Set the second digit with switch. * After setting the final Time Press Stop switch, and the sat time will display. * Start the machine with start button and the machine will start.

INDICATION NORMAL - 5MM RED LED REVERSE - 5MM GREEN LED. Current Level - 0 to 30mA INPUT PROTECTION - Glass Slow Blow Fuse, Rating of 500mA / 250v AC MAINS VOLTAGE - 230 AC + 10% 50HZ.

Accessories provided with the machine. * POWER CABLE * PATIENT PAD ( IONTOPHORESIS ) * PLASTIC TRAY ( IONTOPHORESIS )

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