Safety & comfort

Device safety and ease of use are crucial to ensuring that regular treatments can be carried out effectively, safely, comfortably and efficiently. What sets a modern iontophoresis device apart in terms of safety and comfort?

Device safety as a condition for approval

To protect users, iontophoresis devices must meet minimum safety standards. Iontophoresis devices must therefore first be authorised as active medical devices before they can be placed on the market. Various international safety standards must be complied with for this authorisation.

In the European Union, the approval requirements have been tightened. The new Medical Devices Regulation (EU-MDR 2017/745) additionally requires that the benefits and safety of the respective device be demonstrated by proprietary clinical data. A modern iontophoresis device is already authorised under the new EU-MDR 2017/745. Older devices that were authorised under the old Medical Devices Directive (93/42 EEC) may only be placed on the market until the end of 2028.

Proven device safety through EU MDR approval for active medical devices

Additional security features

Modern tap water iontophoresis devices are equipped with additional safety features. This makes their use with electricity and water particularly safe. Risks and side effects are thus largely avoided.

  • Protection against electric shock in the event of a circuit interruption
  • No exposed metal contacts or electrodes
  • Metal-free electrodes to prevent allergic reactions
  • Flexible electrodes for even current distribution
Traditional tap water iontophoresis using metal electrodes

Comfort

Iontophoresis treatment should be as comfortable and easy as possible for the user to carry out. The following device features make the treatment significantly more comfortable:

  • Direct current and pulsed current in a single device, freely selectable
  • Comfortable armrests for a relaxed posture
  • Intuitive operation
  • Pause and memory functions
  • Automatic polarity reversal

Effectiveness

In addition to the safety and comfort of the devices, there are also significant differences in terms of effectiveness. Tap water iontophoresis must be used regularly and over the long term, and therefore takes time. With the right device, the duration of individual treatments as well as their frequency can be reduced.

  • Simultaneous treatment of hands and feet using appropriately sized basins
  • Shorter treatment times thanks to higher current strengths of up to 30 mA, provided this is individually tolerated