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idromed

5 PS

NSTRUCTIONS FOR USE

Rev. 06/2016

Page 3

Part I

–

General Safety and Compliance Information

Dear Sir or Madam,

You have purchased an

idromed

5 PS

, the iontophoresis device for treatment of

excessive sweating (hyperhidrosis) of the hands, feet and armpits. We hope that you will
be satisfied with the

idromed

5 PS

. You will help assure your own satisfaction by

carefully reading and observing all the following instructions before using the device.

Sincerely yours,

Dr. Hoenle Medizintechnik GmbH

Important notes for your safety

Please read these instructions before using the idromed

5 PS and observe them

carefully

1.1

General safety instructions

In case of contraindications as described in section 2.3, idromed

5 PS

should

not

be used or only in consultation with the attending physician.

Using the device and another high frequency surgical device at the
same time can cause burns under the electrodes.

Operation in close proximity (less than 1m) to a medical device for short
wave or microwave therapy can cause fluctuations in the output levels
of idromed

5 PS.

Application of the electrodes on or near the chest may increase the risk
of ventricular fibrillation.

Use extra caution when operating with effective current densities of
more than 2 mA/cm² on any electrode surfaces.

Содержание 111001

Страница 1: ...tructions for use idromed 5 PS Item no 111001 EU plug silver Item no 111501 EU plug white Item no 111003 UK plug silver Item no 111503 UK plug white Please read these instructions carefully before beginning treatment ...

Страница 2: ...ions 9 PART II OPERATING INSTRUCTIONS FOR THE IDROMED 5 PS 10 3 Scope of delivery description and setup 10 3 1 Scope of delivery 10 3 2 Description 11 3 3 Setting up the device 12 4 Performing therapy 13 4 1 Preparing treatment 13 4 2 Types of treatment 14 4 3 Treatment of hyperhidrosis of the hands and or feet 14 4 4 Treatment of hyperhidrosis in the armpits 17 4 5 Tips and information 18 4 6 Cle...

Страница 3: ...ead these instructions before using the idromed 5 PS and observe them carefully 1 1 General safety instructions In case of contraindications as described in section 2 3 idromed 5 PS should not be used or only in consultation with the attending physician Using the device and another high frequency surgical device at the same time can cause burns under the electrodes Operation in close proximity les...

Страница 4: ...f the feet nail folds or armpits as well as areas that are susceptible to eczema must be covered with Vaseline or a fatty ointment since conductivity is elevated in these areas Please cover only these areas Adjustment of the current should be performed individually for each user The current is optimal when the treatment does not cause stitches or burning The current levels specified are maximum pe...

Страница 5: ...ilities or doctors offices who are to work with idromed 5 PS must before they begin agree to observe the regulations on occupational safety and accident prevention read the chapters on safety and the warnings in this manual and continually observe them during operation Apart from adhering to the instructions for use no further technical requirements are needed for its operation 1 3 Use in home tre...

Страница 6: ...alfunctions that could affect safety must be corrected immediately 1 5 Intended use The idromed 5 PS is an iontophoresis device for the treatment of hyperhidrosis of the hands feet and armpits If the patient operates this medical device during its application completely and without assistance then the patient becomes the operator The user may only operate the device in accordance with all the user...

Страница 7: ...pressure switch Safety Class II devices Application part type BF IP 21 Protection class against ingress of dirt and water Manufacturer s name and address Observe instructions for use CE mark with symbol of the designated authority Do not dispose of with household waste See also Chapter 10 See warnings in instruction manual ...

Страница 8: ...ctions page 9 2 2 Indication According to the latest findings treatment of the following indications is promising Hyperhidrosis of the hands feet and armpits Multiple therapy resistant Verrucae Vulgares on hands or foot soles Dyshidrotic hand or feet eczema Sudeck s syndrome Gramnegative infections of the interstitial spaces between the toes the keratoma sulcatum and fungal infections mycoses poss...

Страница 9: ...e without additional treatment after 1 hour Dry cracked skin Can be minimized by the use of cream Distressing pain in areas with injuries or rashes Cover injuries or inflamed areas of the skin with Vaseline 2 5 Environmental conditions The idromed 5 PS is designed to be used in dry rooms with an ambient temperature of 15 C to 30 C 59 F to 86 F Do not operate in rooms with more than 85 humidity Alw...

Страница 10: ...med 5 PS tap water iontophoresis device Basic unit made from Terluran 1 x Power adapter 24 V AC DC ADAPTER type UE24WCP1 240030SPA or 12 V AC DC ADAPTER type KNW24U20A 120B0 I4410VL 2 x aluminium plate electrodes nickel free 2 x electrode cables 2 x plastic grids 2 x foam edge protectors 1 x shock resistant PVC case whose two separable case shells also serve as treatment trays 1 x patient s diary ...

Страница 11: ...ic treatment set consists of the components described in section 3 1 Scope of delivery The two halves of the supplied protective case serve as treatment trays Mount the idromed 5 PS following the steps described below Remove label and protective film from the electrodes prior to first use For proper implementation of treatment and for your own safety the device may only be operated with the enclos...

Страница 12: ...parated for easy emptying after treatment To do this open the case completely place it on a flat surface and pull the two halves gently apart in the direction indicated by the arrow 3 The edge protection prevents uncomfortable pressure on the forearms Attach the edge protection to the case edges 4 The connectors for the electrode cable are on the outside left of the idromed 5 PS Connect the electr...

Страница 13: ...apter into a properly rated outlet 100 240V 50 60Hz The light on the power adapter will turn green The device is now ready for use 4 Performing therapy 4 1 Preparing treatment Remove all jewellery from around areas of treatment Thoroughly clean the body parts to be treated to remove any possible grease or cosmetic residue If the body parts to be treated have any damage to the stratum corneum minor...

Страница 14: ...treatments Simply swap the connections of the electrodes exchange the positive and negative connections The current level should be adjusted individually for each user The following specified current levels are the maximum permitted levels In general however the levels to be used are significantly lower The maximum allowable levels are as follows For the treatment of hands 15 mA For the treatment ...

Страница 15: ...ly the hands are being treated Fig 3 on the bottom right shows the positioning if only the feet are being treated Fig 2 Fig 3 Set the rotary switch so that the indentation is level with the dot on the case before switching on the device Turn on the device by pressing down the dark gray knob that regulates the current Experience has shown that the desired therapeutic levels can best be adjusted to ...

Страница 16: ...um allowable amperage for each area To set the amperage hands or feet can safely be taken from the treatment trays even with the power on Please dry off your hands before you adjust the amperage on the device The therapy time is 15 minutes The remaining session time can be seen on the display If therapy is interrupted the device stores the remaining treatment session time If the therapy was interr...

Страница 17: ...the sponge bags are too dry there is considerable risk of burns Attention Direct skin contact with the metal electrodes can cause burns Put the electrodes completely into the wet sponges Use the two electrode cables to connect the electrodes to the positive and negative poles of the device Set the rotary switch so that the indentation is level with the dot on the case before switching on the devic...

Страница 18: ...nce a stitching or burning sensation the current is set too high and must be decreased until the feeling ceases If no stitching or burning occurs at maximum amperage the treatment should be carried out with the maximum allowable amperage for each area After the treatment period remove the sponge electrodes from under your armpits Dry your hands thoroughly Turn off the device by pressing the knob d...

Страница 19: ...every treatment and dry the trays electrodes and cable with a cloth Disinfect the treatment set case plate electrodes and cover mats with a commercial disinfectant if needed Discoloration of the electrode surfaces may occur after the first therapy sessions and is normal Wipe the device with a damp cloth only when needed Make sure no water gets into the device Never use abrasives or solvents such a...

Страница 20: ... may not be performed by the operator or user 6 Service If you notice a problem with your idromed 5 PS please start by reading Chapter 7 Troubleshooting If you cannot resolve the fault this way please call the following contacts for assistance For questions about operation service and spare parts orders please contact us at Main Office Dr Hoenle Medizintechnik GmbH Dornierstrasse 4 Phone 0049 0 81...

Страница 21: ...ted tap water or non carbonated mineral or bottled water may be used For axillary treatment check whether the sponge pockets are wet enough A depilation of hair under the armpits is recommended The green LED on the power supply AC DC does not light up It may be that the brightness of the room is making the LED light hard to see Please shade the LED light with a hand and check to see if it is visib...

Страница 22: ... little i e the amount of fluid in the body is not sufficient to pass the current Please drink 1 5 2 liters daily the horny layer especially for foot treatment is too thick Solution take a 10 minute foot bath in clear water without additives to soften the horny layer and to allow the current to flow while axillary treatment the sponge bags are not sufficiently soaked they should be soaked in water...

Страница 23: ...tioning safety and protection devices Ignoring the instructions in this manual concerning the commissioning maintenance and operation of the device Unauthorized modifications to the idromed 5 PS Repairs carried out by staff that is not authorized by Dr Hoenle Medizintechnik Accidents caused by foreign bodies or force majeure 9 Ordering spare parts The following spare parts optional accessories are...

Страница 24: ...the idromed 5 PS Type idromed 5 PS Item number 111001 silver 111003 silver UK plug 111501 white 111503 white UK plug Device dimensions L x W x H 210 mm x 120 mm x 70 mm Case dimensions L x W x H 290 mm x 390 mm x 110 mm Total weight Base unit case and accessories 2 5 kg Power supply Power Supply 100 240V 50 60Hz Type UE24WCP1 240030SPA or Power Supply 100 240V 50 60Hz Type KNW24U20A 120B0 I4410VL ...

Страница 25: ...age is displayed After turning off and on again the device is ready for use Protection class II protective insulation Medical Device Class II a Protection class against ingress of liquids IP21 Labeling Current path Output pulse power peak current treatment max 25mA treatment voltage max 59V Output waveform rectangle 10kHz PWM ratio 50 50 All technical data are given with an accuracy of 3 Output wa...

Страница 26: ...tion The medical device idromed 5 PS meets the requirements of Directive 2011 65 EU of the European Parliament and of the Council of 8 June 2011 on the restriction of use of certain hazardous substances in electrical and electronic equipment The device was tested for biocompatibility and classified as harmless Standards and tests The idromed 5 PS has been tested to the following standards in accre...

Страница 27: ... COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT GUIDELINES Electrostatic Discharge ESD acc to IEC 61000 4 2 6 kV Contact discharge 8 kV Air discharge 6 kV Contact discharge 8 kV Air discharge Floors should be wood concrete or ceramic tile If the floor is covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst immunity test acc to IEC 61000 4 4 2 kV...

Страница 28: ... apply in all situations The propagation of electromagnetic waves is influenced by absorptions and reflections from structures objects and people a b The field strength of stationary transmitters such as base stations of cordless telephones and land mobile services amateur radio stations AM and FM radio and TV transmitters can theoretically not be predicted with accuracy To determine the ELECTROMA...

Страница 29: ... PATIENT area could lead to disturbance NOTE 2 These guidelines may not apply in all situations The propagation of electromagnetic waves is influenced by absorptions and reflections from structures objects and people 12 Disposal The idromed 5 PS is designed for durable and reliable operation Should the idromed 5 PS no longer be used and have to be disposed of please note that electronic components...

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