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The Principal Medical-Technical Requirements And Recommendations As To The Choice of the Medical Ozonizers
 The Principal Medical-Technical Requirements And Recommendations As To The Choice of the Medical Ozonizers
With the purpose of spreading new methods of treatment, consolidating and coordinating research, academic and medical activity in the domain of ozone therapy, the Ukrainian association of ozone therapists and producers of medical equipment was created and registered on the initiative of medical and technical educational establishments, clinics, funds and organizations in April of 2000.

The members of the Ukrainian association are: medical educational institutes and academies, scientific-research institutes, clinics, enterprises, funds and organizations of different patterns of ownership from all the regions of Ukraine as well as from international organizations of the Russian Federation, Lithuania, Poland, Germany, Italy, Turkey, Moldova, Kazakhstan, Tajikistan, Azerbaijan, Uzbekistan, Georgia, etc. 

While choosing ozonizers, physicians are most often governed by price indicators of the equipment and the basic specifications, without paying the due attention to the technical part and the issues of safety of its application. Unfortunately, some producers, taking advantage of the absence of medical-technical requirements and recommendations as to the selection of the equipment, mislead potential customers as to technical specifications and the exploitation potential of the equipment. 

Summing up the European and Russian experience gained over the last thirty years, as well as the research data and practical experience of Ukrainian physicians, the members of our Association among them, over the recent twenty years, the Ukrainian association of ozone therapists and producers of medical equipment together with Kharkiv Medical Academy of Post-Graduate Education, Kharkiv State Medical University and the Institute of Ozone Therapy and Medical Equipment (Kharkiv) has developed and approved of the following basic medical-technical requirements and recommendations that modern ozonizers must correspond to in 2000:

1. The Medical ozonizer must absolutely be legalized, i.e. introduced into the Register of the Ministry of Public Health of Ukraine and have the Certificate of State Registration in the Ministry of Public Health of Ukraine. Medical equipment not included into the Register of the Ministry of Public Health of Ukraine is illegal, and its exploitation is punishable (up to criminal liability) both for the organizations using non-certified equipment and for the physicians.

2. The reliability, quality and safety of ozonizers exploitation must be secured by various electrical and automatic devices protecting the apparatus functioning, preventing it from malfunctioning, controlling and switching it off in case of emergency, fallacious actions of staff and overheating of different assembly units (power supply units, flash chambers, etc), with the mandatory installation of the thermo-sensor and a highly sensitive device, cutting off the oxygen supply at the slightest chance of fire hazard. 

3. The producer must guarantee the safety of treatment, excluding the possibility of infecting patients by way of the ozonizer, foreseeing protection of staff from toxic influence and providing the accuracy in measuring associated signaling channel in the course of treatment.

The construction of ozonizers must categorically exclude the possibility of the transfer of infection or various pathogenic bacteria and fungi from contagious and infected patients to the medical ozonizer with their further possible spread from the apparatus to the patients receiving ozone therapy. 

The algorithm of the ozonizer functioning is set and controlled with the help of microprocessors and control systems which must automatically stop and turn off the ozonizer (in case of ozone leakage, emergency and fallacious actions of staff).

4. The stability of the ozonizer functioning during the whole term of its exploitation providing the possibility of automatic keeping different concentrations of ozone to a high accuracy within a wide range from 0 to 80,0 mg/l with an interval of 0,1 mg/l. 

5. The guaranteed purity of ozone-oxygenic mixture must be secured thanks to the the additional use of a multi-tier filter of the afterpurification of oxygen and a specialized construction of the flash chamber with a double barrier.

Non-purified oxygen may contain admixtures of microparticles of technical oils and other substances, which leads to the formation of toxic products in the ozone-oxygenic mixture (fatty acids, ketone, aldehyde, etc) in the process of electrical synthesis of ozone. While using the constructions of flash chambers without a double barrier the contamination of associated signaling channel with microparticles of the electrode metal may occur. These are only the ozonizers that produce absolutely pure ozone-oxygenic mixture that can be used in medicine for parenteral application, otherwise the consequence of the treatment can be unforeseen, especially while using the method of intravenous injection of ozonized physiologic saline, which happens to be an ideal trap for toxic admixtures. 

6. The wide range of measurement and regulation of the concentration of ozone-oxygenic mixture from 0,0 to 80,0 mg/l with the interval of 0,1 mg/l must be guaranteed at any set speed of oxygen supply irrespective of the fluctuations of the input pressure, electric voltage or other parameters. Each specific value of ozone concentration is set by a physician and is displayed on the monitor. 

7. The accuracy of measurement of ozone concentration in associated signaling channel (inaccuracy not more than ±5%) must be guaranteed by a system of automatics of the ozonizer and must be automatically kept by a system of stabilization, and after checking the quantity of the produced concentration on the built-in gas analyzer (the gauge of ozone concentration) feedback coupling must be introduced, i.e. the system of the secondary inverse automatic regulation and control with microprocessor systems of automatic control for the compensation of the influence of various factors (oxygen pressure measurement, fluctuations of current frequency or voltage in the electric mains).

8. The ozonizer must definitely have the Certificate of GOSSTANDART, i.e. to have a metrological check of the accuracy of keeping ozone concentration (inaccuracy not more than ±5%) in all the ranges of the produced ozone-oxygenic mixture, as well as the speed of the gas stream and its functioning time.

9. The smooth or discrete regulation and the measurement of the speed of oxygen supply and ozone-oxygenic mixture from 0,25 up to 1,0 l/min, with an inaccuracy of up to ±10% must be set, fixed and strictly kept by the automatics on the monitor.

10. The duration of the ozonizer functioning while carrying out a procedure must be set by a physician and be displayed on the monitor, it also must be automatically turned off by the electric timer upon its termination, which considerably simplifies the realization of ozone therapy methods. 

11. The possibility of setting on the ozonizer screen different combinations of the parameters of carrying out a procedure (ozone concentration, the speed of mixture supply, the duration of a procedure execution) allows physicians to exercise an individual approach to patients’ treatment, to hold a sensible, predictable, dose-dependent ozone therapy, to measure in a subtle and accurate way the quantity of ozone, using it similarly to pharmacological devices. 

12. The resource of the flash chamber must be no less than 10000 hours, which allows exploiting the ozonizer over a long term (in the course of ten years).

13. The producer must provide the warranty repair of the ozonizer for a term of one year and its post-warranty service within the whole term of exploitation, but for no less than a 10 years’ term. While selling imported ozonizers, alongside with the contract, the seller must pass over to the buyer the documents on custom registration of the apparatus transportation and the receipt on paying a custom duty, as the above documents will become necessary in case of the apparatus transportation abroad for the purpose of repairing. 

14. The risk of an accidental inhalation exposure must reduced to a minimum due to the application with the purpose of ozone decomposition of a reliable catalytic or thermo-electrical decomposer, ozone-resistant materials, safe and hermetic execution of all connections. The decomposer is to provide in the operating range the ozone concentration lower than MPC = 0,1 mg/m3 on condition of its continuous, hours-long functioning. 

15. The producer must equip the ozonizer with all the necessary gear and facilities so that it may carry out no less than 30 different methods of ozone therapy in different medical domains, with an ozone decomposer, as well as scientific-methodological literature and methods of ozone therapy approved of by the Ministry of Health of Ukraine. 

16. The power consumption of the medical ozonizer must not exceed 100 W at the voltage of 200 V. For medical ozonizers the power consumption is one of the most important indicators, as it allows to judge about the technical level of the apparatus and its producer. The greater power consumption of the ozonizer is, the greater the heating of its inner assembly units is and the lesser its technical safety is. 

17. The design concept of the flash chamber of the medical ozone generator must necessarily be performed with a double barrier as the majority of the best international counterparts have. Purified by way of an additionally set multi-tier filter oxygen must get to the clearance between the coaxically placed (inserted one into the other) two glass tubes with a double barrier. Alongside, one electrode must be presented by a metallized external surface of the tube of a bigger diameter, while the second electrode must be presented by a metallized surface of the tube of a smaller diameter. In the process of the electrical synthesis of ozone oxygen is supplied to the clearance between the two glass tubes, through which a barrier electrical discharge passes. Electric impulses are sent to the metallized electrodes isolated from each other by the two glass tubes. When high voltage (up to 15 kW) is conveyed to the metallized electrodes, an electrical discharge appears in the clearance between the external and the internal tubes, i.e. the gas circuit of the ozone generator must be constructively designed in such a way that an oxygen stream, passing through the discharge interval between the glass tubes of a flash chamber, in which medical ozone is produced, may not come in contact with the metallized electrodes and, respectively, the transfer of ions and molecules of the metal of the electrodes as well as their oxides to the ozone-oxygenic mixture may not occur at the time of the electric discharge. A double barrier is a very important indicator, as the safety warranty is primarily involved, as the parenteral use of ozone therapy may become possible only in case the ozonizer produces the medical ozone of secured purity. The physician must not have the slightest doubt as to the purity of the ozone-oxygenic mixture being used (as to the absence of admixtures in it). 

18. The way to handle the ozonizer and the information about the functioning of all its systems must be displayed on the multifunctional monitor. Despite the complexity of modern ozonizers, handling their functioning must be simple and convenient.

19. The ozonizer must have the respective outlet-socket allowing to plug in to the personal computer and to be easily integrated into the automatized working place of a doctor of any profile.

20. The ozonizer must provide the possibility of a syringe filling with an ozone-oxygenic mixture. 

21. In case of the violation in the regimes of the ozonizer functioning or in case of the fallacious actions on behalf of the staff (inadequacy in oxygen pressure, considerable fluctuations of frequency and voltage in electric mains, violations in the regime of the flash chamber functioning or automatics handling), the apparatus must automatically turn off. 

22. To ensure greater safety of the process of exploiting the ozonizer, there must be an additional reducer of delicate adjustment and pressure limitation installed at the oxygen input inside the apparatus.

23. All physicians resorting to methods of ozone therapy in their practice must be taught both theory and practice of ozone therapy application at specialized advanced training courses for physicians (the project is realized by Kharkiv State Medical Academy of Post-Graduate Education together with the Institute of Ozone Therapy and Medical Equipment) with further granting the respective certificate. Nurses and medical technicians, serving the equipment, must also follow respective training courses, including the safety technique while working with electronic appliances and devices using high pressure