IDROSTAR PRO PULSE Manual

Manual Contents Warnings

3

Side effects

4

Introduction to Idrostar Pro Pulse

4

Treatment of Children and the use of Pulsed Current

5

Contents

6

Description of the controls

7/8

Remote Current Controls

10

Operational and Treatment Principles Before treatment Treatment Protocol Treatment times

11 11 12 12

Treatment of hands only Setup Treatment

13 13 14

Treatment of feet only Setup Treatment

16 16 17

Treatment of hands and feet Setup Treatment

19 19 22

Maintenance of Idrostar Pro Pulse

24

Battery Maintenance

24

Recharging the battery

24

Commonly asked Questions and their Answers

25

Guarantee

27

Technical characteristics

28

Waste disposal

29 2

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 Idrostar pro pulse 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. : This symbol means that you must have to read this document before using the machine. : This symbol means that you are using a BF electrical class equipment. : This symbol means DC Voltage.

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SIDE EFFECTS / PRECAUTIONS • An unpleasant electric impulse (approximately 30V, but not dangerous) will be felt if the patient breaks the circuit during treatment by lifting a hand or foot out of the water, or changing the polarity whilst the current is on, this is much less apparent if in pulse current mode. • Sensation of mild burning if the metal electrode is touched. • Microbruising if the intensity of treatment is too great. • Moderate hyperkerotosis if treatment sessions are too frequent. • Itchiness of the treated area after treatment. Apply a good emollient or moisturiser post treatment if this occurs or hydrocortisone if extreme erythema occurs.

Introduction to the Idrostar Pro Pulse The Idrostar Pro Pulse is designed for the treatment of palmar, plantar & axillary (underarm) hyperhidrosis. It can also be used for the treatment of Warts, Verrucae, Chilblains or acrocyanosis, for protocols to treat these other indications please contact STD Pharmaceutical. The machine can treat two extremities or all four extremities at once without assistance, by using the remote current controls. The machine can be used for treating the axillae, however you will need separate electrodes and sponge pockets which need to be ordered from STD Pharmaceutical Products Ltd, these will come with separate instructions. The axillae should NOT be treated at the same time as hands and feet. As soon as the current exceeds 2 to 3mA, the timer (which indicates minutes run) will start running. If the machine is not used for more than 5 minutes, it will switch itself off to save battery power. 4

It is important not to remove hands or feet from the baths whilst treatment is in progress. If this occurs you may feel an electrical impulse and the current will immediately drop to zero, this is felt less with the pulse current. The current generators are powered by 1 X LEAD BATTERY – 12V/2.2Ah The current indicator shows the current in mA in graduations from 1 to 30, but we recommend that you do not exceed 20mA when treating hands and / or feet. The treatment is found to be successful in approximately 85% of patients when using only tap water on the hands and feet and about 70% of patients when using tap water in the axillae. 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. Pulsed Current Pulsed current is ideally used for those who are sensitive to direct current and we recommend that it is always used for treatment of the axillae as sensitivity is not uncommon in this area. In pulsed current mode, the perception of current flow is less for the user, which therefore allows higher treatment currents for sensitive people, with equivalent therapeutic results.

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Contents Your Idrostar Pro Pulse is delivered with: 1 pair of plastic hand baths (small) 1 pair of stainless steel electrodes for hand baths (small) 1 pair of acrylic grills for hand baths 1 pair of plastic foot baths (large) 1 pair of stainless steel electrodes for foot baths (large) 1 pair acrylic grills for foot baths 1 pair of remote current controls 2 pairs of electrical leads with stainless steel crocodile clips 1 mains charger 1 Instruction manual

Portable Case Foot electrodes and grills

Charger Instruction Manual

Idrostar Pro Pulse

Remote Controls

Hand Baths

Foot Baths

Connection leads

Hand electrodes and grills

Fig 1: Contents of the Idrostar Pro Pulse

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Description of the Idrostar Pro Pulse

C B

F

A

D E

Fig 2: showing the Idrostar Pro Pulse with the end views. A.

Main control Panel for the generators - detailed instruction for the individual controls are shown below:

B.

The remote current controls for the intensity of generator 1, - If this jack is not plugged in the intensity is controlled using the controls on the main panel.

C.

Output sockets for generator 1 (on the left hand side of the machine)– There are two sockets differentiated by Red (+) and Black (-), this is to aid when setting up the machine. So that the cables are not put into the wrong sockets, it is important to plug the red cable into the red socket and the black cable into the black socket. The polarity is changed during the treatment by the use of the polarity switch. (detailed on page 8)

D.

Two output sockets for generator 2, (on right-hand side of the machine) see comments for point C above.

E.

The remote current controls for the intensity of generator 2, see comments for point B above.

F.

Mains charger socket - The machine contains one Lead Battery – 12V/2.2Ah. (When fully charged they should last 3 treatment sessions). The machine will NOT work if the charger is plugged in.

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The Controls for the Idrostar Pro Pulse

6 1

2

10

14

3

11 7 4 5

8

12 9

13

Fig 3: showing the Idrostar Pro Pulse control panel. 1

Current indicator Generator 1: This display shows the level of current in mA that is flowing in the circuit.

2

Closed Circuit Light Generator 1: This light is illuminated only when the circuit is complete and a current is flowing. The circuit is only complete when the extremities are in the water baths.

3

Polarity indicator and switch for generator 1: This section informs the operator of the polarity. In the centre is the polarity switch. The light is illuminated either in the left of the section or right of the section depending on the polarity of the output. Normal means the red lead is the anode when in reverse the red lead becomes the cathode. Refer to the treatment protocol for the procedure to be followed.

8

4

Increase Intensity control for generator 1: The buttons 4 and 5 control the intensity for generator 1, (when either another person is present when treating hands, or if treating feet only). If the remote current controls are unplugged , then these controls are to be used to increase (button 4) and decrease (button5) the intensity; they can also be used to override the remote current controls. The patient is only able to use these controls when their hands are not being treated. If the patient does not wish to use the remote current controls, whilst having their hands treated, a second person must be present to control the intensity.

5

Decrease Intensity control for generator 1: See 4 above.

6

Timer – This starts when the current in generator 1 is increased above 2-3mA. The time displayed is in minutes. After 10 minutes the display starts to flash this is to advise the user if they are treating hands only, hands and feet together or axillae that it is either time to change the polarity or finish treatment.

7

Battery status - the three lights in the top of this section show the status of the battery. Green (right-hand): batteries are between full and three quarters charged. Yellow (Middle): batteries are between three quarters and a quarter charged. Red (left-hand): less than a quarter charged and at the end of the current treatment will require charging.

8

Charging light – The red light below the word “battery” shows that the machine is being charged and whilst this is lit the machine will not work.

9

This section switches the machine ON and OFF.

10

Closed Circuit Light for generator 2: See comment under point 2.

11

Polarity indicator and switch for generator 2: See comments under point 3.

12

Increase Intensity control for generator 2: see comments point 4 and 5.

13

Decrease Intensity control for generator 2: see comments point 4 and 5.

14

Pulse current indicator and switch. The default setting for the machine is pulsed current. When the light is on this indicates the pulsed current is on and when the light is off it is the DC current.

9

The remote current controls

Fig 4: showing the remote current controls. These are placed in the hand baths and are designed so that the patient can adjust the intensity of the current themselves during treatment which means the patient can treat themselves without the need for an assistant. These are remote controls for the buttons 4,5,12 and 13 in fig 3 page 8. When using the remote controls it is important not to remove hands from the baths. There are two remote controls to control each of the generators separately. When plugged into the left side of the machine (Point B Fig 2) it will control generator 1 and when plugged into the right (Point E Fig 2) it will control generator 2.

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Operational and Treatment principles Hands and Feet Hyperhidrosis. The hands & feet should be placed in the water baths ensuring the water covers the affected areas. Once the machine is switched on and the current has been increased above zero, an electrical circuit is formed. If the Normal polarity light is illuminated (Area 3 Fig 3), then the conventional current will pass down the red cable to the electrode, through the water and into the skin, through the body by the most direct route and then to the extremity in the other bath. It crosses from the skin to the electrode connected to the black lead, by passing through the water, and back to the generator. For both the above indications it is important that the current should pass as above for a specified time period (as detailed in the protocols below) the current should then be reduced to zero and the polarity changed by using the buttons marked 3 and 11 in fig 3. Once the polarity has been changed, the conventional current will flow in the reverse direction for the specified time. The current should be set by either using the remote current controls, or the buttons on the control panel. The current should not exceed 20mA and MUST be set at a tolerable level for the patient. They will feel a tingling or ‘pins and needles’ type sensation at a certain level of current. Everyone has a different tolerance level. This may change both during the session and from session to session. There may be some side effects from the treatment; these are always benign and mild and are listed on page 4. Before Treatment • Ensure all jewellery and body piercings are removed. The current never travels above the neck, so amalgam fillings, dental braces and earrings do not pose a problem with 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 such as Vaseline).

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Treatment protocol The treatment involves passing a current one way for a fixed time and then reversing the polarity for the same amount of time. The time of treatment varies depending on whether you are treating axillae (underarms), hands, hands and feet or feet only. It is important that the treatment protocol is followed for the first phase of treatment. The first month involves seven treatments as follows: First week Second week Third week Fourth week

- Day 1, Day 2 & Day 4. (e.g. Tues, Wed, Fri) - Day 7 & Day 10. (e.g. Mon, Thurs) - Day 15. (e.g. Tues) - Day 22. (e.g. Tues)

It often takes 4 to 5 sessions before the patient will notice a reduction in their sweating. After the seventh treatment session, further sessions will only be needed when the sweating restarts. For maintenance treatments, ensure that these are commenced before hands and/or feet, or axillae become hyperhidrotic. It is best to do a maintenance session just as soon as the hands, feet and/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 your patients are able to maintain their hyperhidrosis with frequent maintenance sessions Treatment times Extremities to be Treated Hands only Feet Only Hands and Feet (both generators) Axillae

Treatment Times Polarity 1 10 mins 15 mins 10 mins

Treatment Times Polarity 2 10 mins 15 mins 10 mins

Total 20 mins 30 mins 20 mins

10 mins

10 mins

20 mins

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Treatment of hands only Setup When treating hands only you will only use generator 1 and will need: 2 hand baths 2 small electrodes 2 small acrylic grills 1 Black lead with crocodile clip 1 Red lead with crocodile clip 1 remote current control if the patient is intended to control the machine themselves

The machine ideally wants setting up on a table which the patient can sit at, resting their arms comfortably on the table.

Insert the electrodes into the small baths, ensuring that the upturned corner of the electrode is placed in the upper left quadrant of the bath. Then place the acrylic grills on top of these. Attach the remote current control to both the metal electrode and acrylic mesh ensuring the acrylic mesh is fixed into position. (If an assistant is going to control the current this is not necessary)

Plug the connection leads into the corresponding colour sockets on the left hand side of the machine.

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If you are using the remote current controls then plug these in as shown.

Using the crocodile clips, attach the leads to the upturned corners of the electrodes (one clip per electrode). We recommend you attach the red lead to the left bath and the black lead to the right bath.

Once the machine is set up as in the picture below add 250mls of tap water to each bath.

Treatment Switch the machine on using (button 9 Fig 3) the machine will light up. The machine defaults to Pulsed Current and therefore to select DC current press button 14 shown in Fig 3 Place a hand in each of the baths, pressing lightly on the acrylic grills, but avoiding contact with the metal electrodes. Without taking hands out of the water, increase the current slowly by either pressing the upward arrow on the remote current control in the left bath or if not using the remote current controls then the assistant should use the increase intensity control button (button 4 Fig 3) on the machine.

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The current should be increased to the maximum comfortable level tolerable, but not above 20mA. A ‘pins and needles’ type sensation may be felt, but this should not be uncomfortable. After 10 minutes the timer will start to flash, turn the power down by depressing the downward arrow on the remote current control or the decrease intensity control button (button 5 Fig 3) until there is no current.

Change the polarity by pressing the normal/reverse button (Button 3 Fig 3). The normal/reverse button will not work unless the power is at 0.

Restart the treatment again and after 10 minutes, turn the power down as detailed above. The treatment is complete. Dry hands and completely dry the machine and all parts.

15

Treatment of feet only Setup When treating feet only, the setup is very similar to the treatment for hands only, except you use the foot baths and you will not require the remote current controls as the patients hands will be free to use the intensity controls. (Buttons 4 and 5 Fig 3) You will only use generator 1 and will need: 2 foot baths 2 large electrodes 2 large acrylic grills 1 Black lead with crocodile clip 1 Red lead with crocodile clip

The machine ideally wants to be placed on a table where the patient can sit with the foot bath under the table.

Place the two foot baths on the floor, Insert the electrodes into the baths, ensuring that the upturned corner of the electrode is placed in the upper left quadrant of the bath. Then place the acrylic grills on top of these.

Plug the connection leads into the corresponding colour sockets on the left hand side of the machine.

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Using the crocodile clips, attach the leads to the upturned corners of the electrodes (one clip per electrode). We recommend to connect the red lead to the left foot bath and the black lead to the right bath.

Once the machine is set up as in the picture below add 500mls of tap water to each bath.

Treatment Place a foot in each of the baths, pressing lightly on the acrylic grills, but avoiding all contact with the metal electrodes. Switch the machine on using (button 9 Fig 3) the machine will light up. The machine defaults to Pulsed Current and therefore to select DC current press button 14 shown in Fig 3

Increase the current slowly by pressing the upward arrow, increase intensity control button on the machine (button 4 Fig 3). The current should be increased to the maximum comfortable level tolerable, but not above 20mA. A ‘pins and needles’ type sensation may be felt, but this should not be uncomfortable. 17

After 15 minutes ( The timer will start to flash after ten minutes this is to advice users who are treating hands only, hands and feet together or axillae to change polarity or end treatment) , turn the power down by pressing the downward arrow intensity control button on the machine (button 5 Fig 3) until there is no current.

Change the polarity by pressing the normal/reverse button (button 3 Fig 3). The normal/reverse button will not work unless the power is at 0.

Restart the treatment again and after 15 minutes, turn the power down as detailed above. The treatment is complete. Dry feet and completely dry the machine and all parts.

18

Treatment of hands and feet Setup When treating hands and feet you use both generators. By using the remote current controls the patient can treat themselves without removing their hands from the water baths. You will need: 2 hand baths 2 foot baths 2 small electrodes 2 large electrodes 2 small acrylic grills 2 large acrylic grills 2 Black leads with crocodile clips 2 Red leads with crocodile clips 2 remote current controls if the patient is intended to control the machine themselves Place the small hand baths on the table in front of the machine and the large foot baths on the floor.

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Insert the small electrodes into small hand baths and ensure that the upturned corner of the electrode is placed in the upper left quadrant of the bath. Then place the small acrylic grills on top of these.

Attach the remote current control to both metal electrodes ensuring that the acrylic grills are fixed into position.

Insert the electrodes and grills into the foot baths ensuring that the upturned corner of the electrode is placed in the upper left quadrant of the bath.

Plug the leads into the corresponding colour sockets on both sides of the machine.

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