IDROSTAR and IDROSTAR + Manual

DESCRIPTION OF YOUR MACHINE AND THE CONTROLS Polarity switch Plastic Grills

Axillae Axillaeelectrodes electrodes&&pads pads

Plastic Box - Baths Digital Display Stainless Steel Electrodes

Remote control Remote current control

Leads Light Indicators Direct/pulsed current button (Idrostar + only)

Forearm Protectors (colours vary)

Your idrostar/idrostar + machine is for the treatment & maintenance of hyperhidrosis and is made to be portable . WARNINGS   

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Do not allow liquids to get into the machine Do not dismantle the machine as there are no serviceable parts and only a qualified technician should do this Although the machine is electro-magnetically compatible, we recommend that you do not use it in the immediate proximity (within 1 metre) of applications that could generate significant electro-magnetic fields or generate short waves, such as your TV monitor, mobile phone, computer, radio or microwave, as such proximity may cause the machine to malfunction. Only use accessories recommended for use with the idrostar & idrostar + as other accessories may cause damage to the machine

CONTRAINDICATIONS 

Cardiac pacemakers, metal orthopaedic implants & pregnancy are contraindicated.

TREATMENT OF CHILDREN The basic treatment is the same as for adults, but because the skin is thinner, we suggest starting with pulsed current (idrostar + only). If the child is able to tolerate 20mA of pulsed current, we suggest that he/she uses direct current for the hands and feet, as the treatment may be more successful. Children should not go above 15mA with direct current. Please seek advice before commencing treatment on children. PRECAUTIONS AND SIDE EFFECTS 

You should not remove or place your hands or feet in the baths whilst the current is on. Doing so will break the circuit which creates an electrical surge that is unpleasant (but not dangerous). If you do break the circuit, reduce the power down to zero and re-start the treatment. Do not put your hands or feet in the baths again until the machine current is reduced to zero and the mA light is off. Then place your hands and/or feet in the same baths and start the session again.

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Sensation of mild burning if the stainless steel electrode is touched during treatment.

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Any broken skin that will be under water should be covered with petroleum jelly (Vaseline) before commencing iontophoresis treatment.

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Reported adverse events are low. People have reported a slight redness/soreness (erythema) and itchiness following treatment, which cleared with no long term complications. If this occurs, we suggest applying a good emollient after treatment or hydrocortisone cream if necessary which is available from a pharmacy.

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Microbruising if the intensity of the treatment is too great.

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Moderate Hyperkeratosis (thickening of the skin) if treatment sessions are too frequent. It is better to have a gap between treatments, than have treatments too frequently.

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The appearance of small vesicles on the skin as a result of excessive pressure applied to the grills & direct contact with the metal electrodes. This may also occur in the axillae if the axillae pad is not wet enough and is not fitted tight enough into the underarm.

MAINTENENCE OF YOUR MACHINE You can clean the baths, grills and electrodes with a diluted disinfectant or detergent. However, the machine should just be cleaned with a soft cloth, lightly moistened with water and a mild detergent. Do not use solvents to clean the machine and never immerse the machine in water. At a later stage you can use stainless steel cleaner on the electrodes if you wish. When the treatment is finished, never place the machine and accessories in the baths when they are still wet. All parts should be completely dry before storing away and we suggest removing batteries to avoid any leakage. USE OF PULSED CURRENT - IDROSTAR + ONLY

Pulsed current light Pulse/Direct current button Picture Picture11

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The current on your idrostar + has direct current (DC) and pulsed current (PC). The idrostar + automatically defaults to direct current when turned on. Direct current is considered to be more successful when treating hands and feet in an adult and pulsed current should be used when treating children, the axillae and for those who are not able to tolerate more than 10mA when using direct current. Generally it is for more sensitive skins. The pulsed current is controlled using the pulse button. (Picture 1) When in pulse mode, the pulse light will illuminate. The pulse button must not be pressed when there is current running through the machine. Ensure that the device shows 0 mA if you are changing from pulsed current (PC) to direct current (DC), or from DC or PC. As a general rule, consider pulsed current to be about twice as tolerable as direct current. If you have purchased iontophoresis axillae pads with your machine, we suggest that you use pulsed current, as axillary skin is more sensitive than the skin on the hands or feet. When you start a session, it is important to use the same current throughout the treatment. Do not switch from pulsed to direct current during the same treatment session.

TREATMENT Treatment may start with a hand and foot on one side (e.g. right hand and right foot) for those with hyperhidrosis of the hands and feet; or for hyperhidrosis of the hands only, both hands can be treated at the same time; likewise, both feet, or both axillae. When hands & feet are treated, the total time is 40 minutes (4 sequences of 10 minutes). To treat both hands simultaneously, either necessitates someone else to be present to turn the current up and down, or, if you have purchased a remote control, then this can be used without anyone else present. The remote control is only necessary if you are treating hands alone. When the hands alone are treated, the total time is 20 minutes (2 sequences of 10 minutes). When the feet alone are treated, the total time is 30 minutes (2 sequences of 15 minutes)

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Please note that the power may increase without help by approximately 1-3 MA every 2 minutes or so. If you are relying on someone else to turn on the power and increase the current, please ensure that they are at hand, in case you need to reduce the current during the treatment session. Ensure all jewellery and body piercings are removed. The current never travels above the neck, so amalgam fillings, dental braces and earrings do not have to be removed when using iontophoresis. The skin surface to be treated must be free of all lesions (if any are present, cover with a small amount of petroleum jelly). Ensure not to put on good skin as it will block the current and the area will not be treated. We recommend that the current should not go above 20mA when using DC . FREQUENCY OF TREATMENTS This treatment protocol should always be adhered to when using the machine for the first time. For maintenance treatments, ensure that these are commenced before hands, feet or axillae are fully sweating again. It is best to do a maintenance session just as soon as the hands, feet or axillae feel clammy and are not fully sweating. For some people this is necessary twice a week, for others, monthly sessions will be all that is required. With time, you will find that you are able to maintain your hyperhidrosis with frequent maintenance sessions. Treatment schedule First week Day 1, Day 2 & Day 4. Second week Day 7 & Day 10 Third week Day 15 Fourth week Day 22

Treatment days Tuesday, Wednesday & Friday Monday & Thursday Tuesday Tuesday

For some people, an almost complete cessation of sweating can be achieved after the 4 th treatment session, but you should continue to the 7th session. After the 7th treatment, further sessions will only be needed just as soon as the sweating restarts. It is then best to commence therapy immediately. (At this stage, only one or two treatments may be necessary). Do not wait for full sweating to return as this will require starting the sessions again from the beginning. SET UP GUIDE – for hands and feet treatment only

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Check leads are fully inserted into the machine and then insert the 4 batteries into the battery compartment according to the + & symbols and replace the casing. (Pictures 3 & 4) 4 alkaline batteries should last for 3-5 sessions, depending on their quality. You should always remove the batteries after treatment to avoid leakage & damage to the machine. If using rechargeable batteries, we recommend a minimum strength of 1600mAh & these will only last for 1-2 sessions. If the batteries have not been inserted correctly, the green ‘ON’ light button will not illuminate. If the display on the machine becomes erratic, then the batteries will need replacing.

Place the baths on a non-metallic table in front of the machine, or on the floor if treating feet. Place a stainless steel electrode into each bath, ensuring that the pin is placed in the upper left corner of the left bath & upper right corner of the right bath. Then place the plastic grills on top of these. Unwind the cables & connect them via the connectors to the stainless steel plates. (Note that one of the cables is marked with a +, making it possible to identify the positive output from the generator) (Pictures 5, 6 & 7)

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FOREARM PROTECTORS Attach the forearm protectors to the baths for extra comfort when treating the hands (Picture 8)

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REMOTE CONTROL If you have purchased the remote control, plug this into the machine and clip it over the grill & electrode in the left hand bath. (Pictures 9, 10 & 11)

Increase current Decrease current

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For treatment of hands only (10 minutes each side = 20 minutes)

 Cover each grill with enough warm tap water to just cover your area of Hyperhidrosis, but do not put in too much as this will be counterproductive. Approximately 350mls for most people would be appropriate. Attach the remote control to the left hand plate & grill. If this has not been purchased, then ensure that there is another person present to turn the current up and down on the machine.

 Switch on machine and ensure it is reading 0 mA and the mA light is off.  Place both hands into the baths with tap water, pressing lightly on the grills, but avoid all contact with the metal electrodes.

 Either enlist someone else to turn on the machine & increase the power slowly, by pressing the ‘+’ button on the

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machine to the maximum level tolerable, or use the remote control to increase the current yourself, by pressing on the up arrow to increase current. This is deliberately a positive action and you should not remove your hand from the baths when doing this. Do not go above 20mA on direct current, but this can be much higher with pulsed current. You should feel a ‘pins and needles’ type sensation, but this should not be uncomfortable. At a certain level you will feel a slight discomfort or pricking. Ensure that the current is not turned up too high as this treatment should not be uncomfortable. During the early sessions higher levels of current may be difficult to tolerate; do not persist in maintaining any uncomfortable level. With repeated sessions the skin will improve and the current can be increased.

 After 10 minutes, ask your helper to turn the current down using the ‘-‘ button, or press firmly on the down arrow on the remote control yourself, until there is no current running. Ensure that the current reads 0 mA

 Switch the polarity switch from 1 to 2.

 Restart the treatment again and after 10 minutes, turn the power down again until the machine is turned off. Ensure that the current reads 0 mA and turn off the machine.

 The treatment is complete. Dry hands and completely dry machine and parts. For treatment of feet only (15 minutes each side = 30 minutes)

 Cover each grill with enough warm tap water to cover your area of Hyperhidrosis, but do not put in too much as this will be counterproductive. Approximately 350mls for most

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people would be appropriate. Just enough to cover the area of sweating.

 Place both feet into the baths with tap water, pressing lightly on the grills, but avoid all contact with the metal electrodes.

 Press the power control button slowly, by pressing the ‘+’ button to the maximum level tolerable. Do not go above 20mA on direct current, but this can be much higher with pulsed current. You should feel a ‘pins and needles’ type sensation, but this should not be uncomfortable.

 At a certain level you will feel a slight discomfort or pricking. Ensure that the current is not turned up too much, as this treatment should not be uncomfortable. With repeated sessions the skin will improve and the current can be pushed up further.

 After 15 minutes, turn the current down using the ‘-‘ button until there is no current running. Ensure that the current reads 0 mA

 Switch the polarity switch from 1 to 2.  Restart the treatment again and after 15 minutes, turn the power down again until the machine is turned off.  The treatment is complete. Dry feet and completely dry machine and parts. For treatment of one hand and one foot (20 minutes one side & then 20 minutes on the other side = 40 minutes)

 Cover each grill with enough warm tap water to cover your area of Hyperhidrosis, but do not put in too much as this will be counterproductive. Approximately 350mls for most people would be appropriate. Just enough to cover the area of sweating.

 Place your right hand and right foot into the baths with tap water, pressing lightly on the grills, but avoid all contact with the metal electrode. (Picture 13)

 See treatment for hands only and ensure to only have 10 minutes for the 1st half of the session before changing polarity by switching the polarity switch from 1 to 2 & 10 minutes for the 2nd half. You will be able to press the ‘+’ & ‘-‘ power buttons with your free hand.

 Repeat this protocol for the left hand and foot.  The treatment is complete. Dry feet and completely dry machine and parts Picture 13 Treatment of the axillae (underarms)

Always use pulsed current

(Picture 14) (Picture 15) Precautions Wash and rinse your axillae thoroughly to remove any trace of soap, antiperspirant or deodorant before use. Sometimes irritation can arise around the underarms after using iontophoresis. If this becomes a problem, hydrocortisone cream 1% can be helpful and is available from your pharmacy and should be used immediately after treatment. We recommend that the axillae are not shaved, waxed or depilated for at least 3 days before treatment. Do not use soap on the sponge pocket after use. Just rinse in warm water.

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1. Before use, rinse the sponge pocket with tap water, ensuring that the pockets are thoroughly soaked. 2. Insert the rubber electrodes into the sponge pockets. (Picture 14) 3. The leads on the rubber electrodes attach directly to the electrode cables, by pushing the socket and plug together & then insert into the machine.(Picture 15)

4. Soak the sponge pockets again in water and insert into axillae, ensuring a good fit. (Pictures 16-19) 5. Once the pockets are in place, turn the power up to a comfortable tolerance level by pressing on the + button on the machine. (Picture 20)

6. Maintain this power level for 10 minutes. Reduce power to zero and turn machine off. Soak the sponge pockets again and insert back into the same armpits, switch the polarity switch to 2 and increase power again for a further 10 minutes. Reduce power to zero and turn machine off. 

The rubber electrode should not come in direct contact with the skin during treatment

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The sponge pocket can be hand washed after use, but should be used only on one user of the machine

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Ensure that the sponge pocket is as wet as possible, as the treatment will be more successful if this is done. Some people find it helpful to soak some gauze swabs in water and place over the sponge pocket once it is inserted into the axillae.

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Frequently asked questions Q A

Is it risky to exceed the recommended treatment time? 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 for treatment of the hands and we recommend that you do this initially. However, excessive over treatment may cause hyperkeratosis (thickening of the skin) which is not preferable.

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What if I miss a maintenance session? If you only miss one day, we suggest you retreat the following day. However, if full sweating has returned, we recommend that you wait at least 2 weeks and carry out the full treatment protocol again.

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I have had an operation which has left me with metal components in my body. Is this a contraindication? If the metal component is not in the currents path, it is not a contra-indication. 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. Small pins & screws are not a contra-indication. Please see diagram below for the current path.

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Is an IUD a contra-indication? Although there are no current studies on the long-term effects of iontophoresis when used with IUD’s; no immediate side effects have been reported and there is no risk to women’s health. The effectiveness of an IUD cannot be guaranteed with or without iontophoresis.

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When I do a treatment my skin goes red above the water level. Am I risking burns? This redness is due to the vasodilation of the skin blood vessels. It is quite common and is of no consequence. If it becomes troublesome, then we recommend putting a thin layer of petroleum jelly, such as Vaseline on the wrist line or just above the water level on the feet. If the red patches are sore or inflamed after treatment, then we recommend you apply a mild steroid cream after treatment such as hydrocortisone 1%.

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What temperature should the water be? We recommend using warm water.

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What does safety mean to us? There is a European legislation that forces manufacturers to submit medical devices for approval, after which they may or may not obtain the EC standard marking. The marking is granted to manufacturers who must submit their devices to national test laboratories, specialised in the medical field. Our machines, the idrostar + the idrostar, the idrostar pro pulse, the idrostar pro, the i2ma & the Iomax 4 do not allow mains connection during operation. Their power sources are either a mains chargeable battery or disposable batteries. Our machines are designed with safety, portability and flexibility in mind, by using batteries which are more than capable of producing the power required to perform iontophoresis successfully. Guarantee

The manufacturers of your machine, (i2m) guarantee that this product is free of faults at the time of purchase and during the following 2 years. If a fault occurs during the guarantee period, the manufacturer will take responsibility under the following conditions: 1.

The guarantee will only be valid on production of the original invoice with the following details filled in – a) The name of the purchaser b) The name, address and stamp of the distributor c) The name of the model and the products serial number d) The date of the purchase i2m reserve the right to refuse this guarantee if all, or part of these details are missing or modified after the original purchase.

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This product cannot be considered defective in material or manufacture if it is not used as recommended. This guarantee does not apply with any adaptations or changes, whether or not correctly performed, or to any damage which may result from this

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This guarantee will not cover – a) The repair or replacement of parts worn out by normal use b) The cost and risk of transport to or from the place of repair c) Damage to this product resulting from abuse or misusage, in particular, but not exclusively to: 1) 2) 3)

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Negligence or fault by the user (used contrary to instructions or design), dropping, breakage or accidental cracking Repairs by non agreed personnel Accidents, natural disasters or all other causes out of control of i2m; in particular, but not exclusively due to lightning, flooding, fire, public disturbance or battery damage to machine.

This guarantee in no way limits the rights of the customer under the national laws in force. In the absence of such national laws, this guarantee, or its use within the EU, will be the sole and exclusive legal recourse of the customer and the manufacturers will not be held responsible for damage whether directly or indirectly resulting from failure to abide by the above conditions.

This machine conforms with the international standards: EN 60601-1/EN 60601-2-10/EN55011/IEC 801-3/IEC 801-2 If this symbol is shown on the products and/or accompanying documents, this means that the electrical and electronic devices must not be disposed of together with the household refuse. For these products to be treated, recovered and recycled appropriately, send them to the designated collection points where they may be deposited free of charge. In some countries, products may be returned to the local retailer if an equivalent product is purchased. By disposing of this product correctly, you will contribute to preserving vital resources and to preventing the possible negative effects on the environment and on human health that might otherwise arise. In accordance with national legislation, sanctions may be applied if this waste is disposed of incorrectly. To find the nearest collection point, please contact your local authority.

This symbol means that the machine should be kept dry at all times.

This symbol means that you are using a BF electrical class equipment

This symbol means that you must have read this document before using the machine

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This standard electrical symbol is the symbol for direct current (DC) Please be advised to keep your original packaging for the duration of the guarantee should it be necessary to return the machine to: