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Hidrex classic ION Manual

Tap water iontophoresis device
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Summary of Contents for Hidrex classic ION

  • Page 2: Table Of Contents

    Basic settings and saving profiles ....................................24 Begin Treatment ..........................................27 Important remarks on therapy safety (protective functions and information) ......................30 Care and maintenance ......................................... 33 Special remarks ..........................................33 User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 2...
  • Page 3 Lifespan ............................................39 Symbol Legend / Manufacturer / Device Identification .............................. 40 Electromagnetic Compatibility (EMC) ..................................41 Waste management and packaging of electronic and devices ..........................45 Technical Data..........................................46 Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 3...

  • Page 4: Read Before Use

    Read before use Your HIDREX iontophoresis device is designed to give you maximum efficiency and operability. It is easy to put into operation and simple to use. Nevertheless, the following safety instructions and legal regulations must be observed and strictly adhered to. The maintenance, care and disinfection instructions described below must be carried out regularly to ensure the proper, safe and long- term operation of your device.

  • Page 5: Your Safety Is Important

    Your safety is important  The therapy device must only be operated with the HIDREX plug-in power supply specially selected for this medical device.  Modifications to the therapy device are not allowed. Do not open the device. This therapy device has no operating parts inside.

  • Page 6: Who Is The Therapy Suitable For? - Contraindications

    (e.g. patients with polyneuropathies)  Apply electrical current through or across the brain, or sinuses (increased risk of ventricular fibrillation)  with suspected or diagnosed heart problems or epilepsy  User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 6...

  • Page 7: Side Effects

    Prevent kinking of the cables and do not expose them to heat or chemicals. Damaged cables must not be reused and must  be replaced with new original Hidrex cables Do not perform iontophoresis therapy in parallel with aluminum-containing antiperspirants in the same treatment area ...

  • Page 8: Intended Use / Mechanism Of Action

    Mechanism of action: During the HIDREX treatment, a current flows through the body regions that are being treated. The water in the trays or pads mediates this current flow. The skin areas in contact with the water will thereby secrete less sweat.

  • Page 9: Treatment Fundamentals

    Polarity reversal and the efficacy of treatment In principle, the effect of HIDREX therapy does not depend on the direction of the current. However, clinical studies have shown that the anode (connector E1, see chapter "General controls") is slightly more effective than the cathode (E2) at the start of the initial treatment.

  • Page 10: Types Of Current

    Any deviation from this procedure leads neither to hazards nor to side effects. Ultimately, the long-term success of therapy is not dependent on the direction of the current. Types of current The HIDREX iontophoresis therapy devices provide different types of current for optimal therapy of different areas:  DC: Direct Current ...
  • Page 11 The pulse width can be adjusted in 10% steps to suit individual requirements in order to achieve the greatest possible comfort with optimal effectiveness.  very sensitive (little current sensation) / adjustable  recommended for all treatment areas effectiveness Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 11...
  • Page 12 Type of current Pulse width classic Pulsed Current (PC) Direct Current (DC) 100 (dc) comfort Pulsed Current (PC) connect Direct Current (DC) 100 (dc) Variable Pulsed Current (VPC) 70, 80, 90 User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 12...

  • Page 13: Installation / Treatment Setup

    Control unit main ON/OFF switch (main power switch)     Connector for AC adapter  (Type: HIPRO10, 12V DC) Jacks for connecting the cable set to the treatment  electrodes (Anode) E1 E2 (Cathode) Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 13...
  • Page 14 AC Adapter Your HIDREX therapy system is equipped with a wide range AC adapter , which is suitable for different international mains electricity (please refer to technical data). Depending on your region, various primary adapters  can be used for the different plug-in systems.
  • Page 15 Part number aluminum electrodes: ION99302 Part number stainless steel electrodes: ION09303 Part number mesh plates: ION18013  To do this, open the case completely and lay it flat on a flat surface! Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 15...
  • Page 16 Part number Set DUO with stainless steel electrodes: ION43005 Axillary applicators  (AX applicator) are required for therapy of the axillae. Part number set AX: ION17013  Part number AX- Replacement cushion: ION19008 User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 16...
  • Page 17 Part number Replacement sponge (3 pieces): ION18016 The neck or back applicators  are needed for the therapy of the neck or back.  Part number neck applicator: ION05315 Part number back applicator: ION05316 Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 17...

  • Page 18: Therapy Preparations (Setup Control Unit)

    Connect the primary adapter  of the AC adapter to a wall socket. Insert the connection cables  into the sockets on the back  of the unit. iii)      (ii) (iii) User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 18...

  • Page 19: Setup For Hands And Feet Treatment

    The backs of the hands or feet should not be covered with water unless you want to treat them specifically. Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect...
  • Page 20 If the therapy does not have the expected effect on the feet, for example, you should treat the hands and feet separately one after the other. User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024...

  • Page 21: Conduct Therapy

    In the reverse order, a safe but unpleasant electric shock could occur despite the appropriate protective circuit. Never switch off the device while treatment is in progress. This is highly likely to result in a safe but unpleasant electric shock ("electric fence effect"). Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 21...

  • Page 22: User Interface

    User interface  Display  Display   Button Button  Display     Button Button Button Button   Button Button User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 22...

  • Page 23: Display Elements

    Indicates the Displays the target active. end of therapy. value of the treatment dose. If STOP is shown, the Displays the therapy was terminated therapy duration. due to an error. Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 23...

  • Page 24: Basic Settings And Saving Profiles

    Basic settings and saving profiles Your HIDREX device offers you several treatment options that you must set before starting treatment. The following paragraph explains how you can carry out these basic settings and save them if necessary. Switch the device on: Once you have set up your therapy system as described in the chapter 'Installation', switch on the control unit using the main switch .
  • Page 25 Please note that holding the buttons for longer may trigger additional functions, depending on the device version and situation. Only Android devices are supported. The app can be downloaded at www.hidrex.com. Rev.: 2.3, 04/09/2024 User manual HIDREX classic...
  • Page 26 Press and hold the buttons  &  simultaneously for about 5 seconds to switch the automatic polarity change connect function (PRF) on or off. Press and hold the button  for about 5 seconds to switch the automatic polarity change function (PWF) on or comfort off. User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 26...

  • Page 27: Begin Treatment

    (pulse width = 100%) once before the first therapy session. Please note that the use of the special applicators is described in separate instructions. These instructions must always be followed. Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect...
  • Page 28 The remaining treatment time is shown in minutes on the display . If the target dose is reached, this display disappears. If the dose setting value is not reached, the display remains on (see also the note on "Dose limitation" on the following pages). User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024...
  • Page 29 (e.g. hands and feet outside the water bath). Failure to do so will often result in a safe but unpleasant electric shock for the user (electric fence effect), despite the appropriate protective circuit. Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect...

  • Page 30: Important Remarks On Therapy Safety (Protective Functions And Information)

    Important remarks on therapy safety (protective functions and information) Your HIDREX therapy device is equipped with several protective circuits for your safety. Immersion and switch-on monitoring As long as you have not closed the circuit through the skin areas to be treated, the device will not deliver a therapy dose. All settings that you make when the therapy circuit is open are saved in the active profile.
  • Page 31 You must restart the device to start a new treatment. Further information on dealing with calcification on the electrodes can be found in the Cleaning, care and maintenance chapter. Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 31...
  • Page 32 +49 2056 98 11 10 E-Mail info@hidrex.de Scan to save the Phone +49 2056 98 11 0 HIDREX Hotline CL = Current-Limitation To start a new treatment, the device must be restarted. User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 32...

  • Page 33: Care And Maintenance

    Multi Patient use The HIDREX iontophoresis therapy devices are suitable to be used by multiple patients in medical facilities to perform initial and / or maintenance therapy under the supervision of an attending physician. As a multi-patient use device, the following protocols should be obeyed: •...

  • Page 34: Care And Purification

    Care and purification For flawless and long-lasting function of your HIDREX system, we recommend the following steps after each use: Attention: Before cleaning, make sure that the device is switched off and disconnected from the power supply. Do not use petroleum, thinner or other solvents.
  • Page 35 HIDREX tap water iontophoresis devices are basically maintenance-free. Nevertheless, for safety reasons we recommend a technical check and safety inspection by an authorized HIDREX repair every 2 years. Suitable measuring and test equipment are mandatory for the technical safety inspection (STK)
  • Page 36 HIDREX iontophoresis devices are reusable medical devices and can be reconditioned after use of a customer. The reconditioning of the devices is classified as “non-critical” The reconditioning should be done only by an authorized HIDREX repair center. If a device is to be reconditioned, the following actions will also be taken: •...

  • Page 37: Troubleshooting

    Troubleshooting If your HIDREX iontophoresis therapy device does not function as described in the accompanying documents and these instructions, please first go through the following checklist and carry out the function test described below before sending the device in for repair.

  • Page 38: Operational Check

    Please send all electrical accessories (AC power adapter , electrodes , and cable set ) together with the control unit as well as the completed repair form (detailed error description). You can find the form at www.hidrex.com under Info ► forms.

  • Page 39: Applicable Regulations And Legal Requirements

    Each successful reconditioning by the manufacturer extends the lifespan of the medical device by 2 years. If the HIDREX iontophoresis system is reconditioned for the same patient, the treatment trays or carrying case (depending on their condition) do not necessarily have to be replaced.

  • Page 40: Symbol Legend / Manufacturer / Device Identification

    Not for General Waste (EU The device is reusable and not contaminated at end of life (complies with WEEE-Directive). States) (ElektroG, WEEE) HIDREX GmbH, Otto-Hahn-Str.12, 42579 Heiligenhaus, Germany, info@hidrex.de, Manufacturer www.hidrex.com CE-Mark, ID# of Notified Body Conformity with health and safety requirements set out in European Directive (93/42/EU).

  • Page 41: Electromagnetic Compatibility (Emc)

    Electromagnetic Compatibility (EMC) HIDREX devices are developed and manufactured after the stipulated guidelines for electromagnetic compatibility (EMC). Attention: Medical-Electric-Appliances are subject to particular EMC precautions and must be installed and be put into operation according to the following EMC-Hints. Wearable and mobile HF-Communication facilities, as portable phones or pagers can influence medical-electric- appliances! Please note the guidelines and manufacturer's declarations according to DIN EN 60601-1-2, which you can request from us.
  • Page 42 (as of May 1994) (the higher the level; the greater the protection). This device has an immunity level of 20V/m with no accessories connected to the device. HIDREX iontophoresis devices should be used in an electromagnetic environment as listed below. Table 1...
  • Page 43 30 % für 500 ms 30 % für 500 ms 0 % für 5000 ms 0 % für 5000 ms H-field at 50/60 Hz 3 A/m 3 A/m IEC 61000-4-8 Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 43...
  • Page 44 0.12 m 0.12 m 0.24 m 0.37 m 0.37 m 0.74 m 1.17 m 1.17 m 2.34 m 3.69 m 3.69 m 7.38 m 11.67 m 11.67 m 23.34 m User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 44...

  • Page 45: Waste Management And Packaging Of Electronic And Devices

    Please help prevent incriminating materials from going into the environment (ElektroG). WEEE-Reg.-#.: DE 42510094 Manufacturer-#. Duales System Interseroh: 134502 (VerpackV) Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 45...

  • Page 46: Technical Data

    The maximum temperature of touchable parts determined in the laboratory under the most unfavourable conditions was 46.2°C. Only applies to devices that have the current type pulse current (PC) or variable pulse current (VPC). User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024...
  • Page 47 Ergonomic tube Water Surface 0,075 0,088 Hand-Feet, HF-Electrode Electrodes Material Dimensions (H x B) HF-Electrodes 1.4301-2b (Stainless Steel) or EN AW 5754 (Aluminium) 34,5 x 11,5 cm pH-Puffer none Rev.: 2.3, 04/09/2024 User manual HIDREX classic comfort connect Page 47...
  • Page 48 +49 2056 98 11 10 E-Mail info@hidrex.de Phone +49 2056 98 11 0 Scan to save the HIDREX Hotline © by HIDREX GmbH Otto-Hahn-Straße 12 42579 Heiligenhaus Germany www.hidrex.com User manual HIDREX classic comfort connect Rev.: 2.3, 04/09/2024 Page 48...

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