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FocusMed’s electromedical devices guidelines

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FocusMed’s electromedical devices guidelines

Premise

These general indications on the use of our devices come from the direct experience we have gained over the years, from the continuous comparison with professionals engaged directly in the field and from clinical trials.

The indications are general, not restrictive, since each patient has peculiarities that require careful evaluation. These general guidelines have not been tested for devices other than ours (e.g. electromedical devices of techarterapy or resistive capacitive diathermy – medium frequencies) precisely because of the different technology behind our high-frequency technology.

How many sessions and how long should them be?

Ciclo trattamento
Diagram illustrative of a cycle of therapy composed of 10 sessions. After the 10 session the cases should be reassesed by the practitioner. Red: severe. Green: in resolution.

The capacitive diathermy protocols tested experimentally consisted of 10 treatment sessions, lasting 10 minutes minimum and 20 maximum. The 10 sessions were carried out over a period of 1 month and then the patients were monitored over time. Studies have confirmed both the effectiveness of the treatment: the results were evident both during the treatment and after the treatment had been terminated. In addition, the safety of the devices has been certified: there were no adverse reactions either during treatment or in the long term.

Therefore we suggest to make:

A course of diathermy therapy of about 10 sessions in total over at least 4 weeks, divided in the following way:

  • 3 sessions per week in the 1st and 2nd week;
  • 2 sessions per week in the 3,- and 4,- week. week.

 

And to not exceed 20 minutes per session or per district.

Frequencies and power output

The most important results of the studies were obtained with 8 MHz. However, in most experimental protocols, it was decided to start the treatment with the lowest frequencies (2 or 4 Mhz) to allow the adaptation of the tissues to the stimuli.

In the more fragile patients the lower frequencies allow a more gradual and physiological adaptation. As the tolerance of the patient increases, the increase in power or frequency during the session is indicated.

We suggest to always adapt the frequencies and the power emitted by our devices to the anthropometric characteristics of the subject: height, weight, body composition and state of hydration.

The best way to adapt the treatment to the patient is to explain and teach them how to report the sensation of perceived heat defining: 0 “No sensation”, 10 “Sensation of pain”. The range between 4 and 6 indicates “pleasant feeling of warmth”, or the goal of our therapy.

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Legislative Decree of 24 February 1997, No 46 Article 21

1. It is forbidden to advertise to the public devices that, according to provisions adopted by decree of the Minister of Health, may be sold only on prescription or may be used with the assistance of a doctor or other healthcare professional.
2. Advertising to the public of devices other than those referred to in paragraph 1 is subject to authorization by the Ministry of Health. On the requests for authorization expresses opinion the Commission of experts provided for by article 6, paragraph 3, of the legislative decree 30 December 1992, n. 541, which for this purpose is supplemented by a representative of the Department of the Ministry of Health responsible for medical devices and one of the Ministry of Industry, Commerce and Crafts.