SAFETY

INTELLIGENT TECHNOLOGY

THE SAFETY OF OUR HIGH FREQUENCIESFOCUSMED® 

Safety first of all: our research and development

The safety of our devices.

The high-frequency devices patented by Focusmed® have an exceptional safety profile, both for the patient and for the operator. This aspect is not to be put aside in the healthcare setting today, given the growing lack of health workers in relation to the needs of the population.

The devices (Pronexibus Plus®, Rinovacell® and Maximum®) have been tested numerous times to ensure their safety profile: we will analyze, step by step, many different sources.

 

The European certification.

First of all, the European certification, and the possibility to use our electromedical devices at the home of patients, are proof that our technology is extremely safe from a technical point of view.

An electromedical device of class 2b, to obtain the international certification, must be subjected to very strict tests of both electrical safety and functionality and have to perform quite well. In practice, the Notifying Body controls all that is the process of developing the electromedical device and verifies that what is declared, in the technical documents, is true. Standards are constantly updated to ensure patient safety at all times.

In practice, the FocusMed®’s devices, have successfully passed such tests, and also received such a positive score that they can be used in the patients’ home setting.

 

The collaborations with the Universities.

The collaborations with the Universities of Padova10Verona11 and Salerno12, which have allowed to arrive at international scientific publications, have highlighted and quantified both the beneficial effects of our technology with controlled high frequencies, and the safety of our electromedical devices: in these studies, in which more than 100 patients were enrolled, no adverse reactions were detected during or after treatment.

 

International references.

We have therefore seen that our devices are safe both from the technical point of view (CE certificate), and from the experimental-therapeutic point of view (collaboration with different Universities).

If this is not enough to be convinced that high frequencies are effective and safe, other evidence can be found in the scientific literature: here we would find that the first attempts to develop electromedical devices using high frequencies date back to 19861 in Japan.

Over the years, other research groups have continued to experiment the use of the high frequencies capacitive diathermy with 8MHz in various contexts: treatment of colon-rectal cancer2, of liver tumors3, of breast cancer4, of cervical cancer5, of lung cancer6,7; of knee osteoarthritis8. In addition, some authors have proposed to develop, after confirming the safety, the protocols of application of the high frequencies so as to compare the results of experimental9.

 

In conclusion.

Therefore it can be said that the electromedical devices FocusMed® are valid both from the therapeutic point of view and their safety profile because:

  • Devices are certified by internationally and nationally recognised bodies.
  • The devices have been evaluated within different Universities.
  • The literature has highlighted a beneficial effect of the high frequencies, especially the 8 MHz in many pathologies.

 

References

  1. Abe, M. et al. Multi‐institutional studies on hyperthermia using an 8‐MHz radiofrequency capacitive heating device (thermotron RF‐8) in combination with radiation for cancer therapy. 58, 7 (1986).
  2. Ohguri, T. et al. Radiotherapy with 8 MHz radiofrequency-capacitive regional hyperthermia for pain relief of unresectable and recurrent colorectal cancer. Int. J. Hyperthermia 22, 1–14 (2006).
  3. Nagata, Y. et al. Clinical results of radiofrequency hyperthermia for malignant liver tumors. Int. J. Radiat. Oncol. 38, 359–365 (1997).
  4. Fujimoto, S. et al. Clinical pilot studies on pre-operative hyperthermic tumour ablation for advanced breast carcinoma using an 8 MHz radiofrequency heating device. Int. J. Hyperthermia 19, 13–22 (2003).
  5. Franckena, M. et al. Long-Term Improvement in Treatment Outcome After Radiotherapy and Hyperthermia in Locoregionally Advanced Cervix Cancer: An Update of the Dutch Deep Hyperthermia Trial. Int. J. Radiat. Oncol. 70, 1176–1182 (2008).
  6. Ohguri, T. et al. Radiotherapy With 8-MHz Radiofrequency-Capacitive Regional Hyperthermia for Stage III Non–Small-Cell Lung Cancer: The Radiofrequency-Output Power Correlates With the Intraesophageal Temperature and Clinical Outcomes. Int. J. Radiat. Oncol. 73, 128–135 (2009).
  7. Ohguri, T. et al. Deep regional hyperthermia for the whole thoracic region using 8 MHz radiofrequency-capacitive heating device: Relationship between the radiofrequency-output power and the intra-oesophageal temperature and predictive factors for a good heating in 59 patients. Int. J. Hyperthermia 27, 20–26 (2011).
  8. Takahashi, K. et al. The effects of radiofrequency hyperthermia on pain and function in patients with knee osteoarthritis: a preliminary report. J. Orthop. Sci. 16, 376–381 (2011).
  9. Shoji, H. et al. A novel strategy of radiofrequency hyperthermia (neothermia) in combination with preoperative chemoradiotherapy for the treatment of advanced rectal cancer: a pilot study. Cancer Med. 4, 834–843 (2015).
  10. Masiero, S. et al. Short-wave diathermy in the clinical management of musculoskeletal disorders: a pilot observational study. Int. J. Biometeorol. (2019) doi:10.1007/s00484-019-01806-x.
  11. ProNexibus Plus® per pazienti con piede equino spastico, Università di Verona, Dr Picelli, 29-30 Novembre 2019, 9° Congresso I.S.Mu.L.T.
  12. Studio RITRALED: Rinovacell® nel trattamento delle lesioni trofiche del piede diabetico, Università di Salerno, Dr Bruno Luigi Farina, 19-21 Settembre 2013, XII Congresso Nazionale AIUC.

 

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