Medical and technical requirements to the options of ozone generators for a receipt and use of medical ozone.

Recommendation on the choice of source of oxygen, generator of medical ozone-oxygen mix and controls of parameters of realization of procedures with the use of ozone-oxygen mix in medicine.

Created: Dr.V.G.Vongay, Dr.Sci.E.I.Nazarov, ratified by scientific advice of Asian-European Union of ozonetherapists of July 15, 2012, Odessa, Ukraine.

Medical and technical requirements to the options for a receipt and use of medical ozone

Recommendation on the choice of source of oxygen, generator of medical ozone-oxygen mixture and controls of parameters of realization of procedures with the use of ozone-oxygen mix in medicine

Generals. Medical ozone is name ozone-oxygen mix with maintenance of ozone in limits from 0.05 to 5 by volume percents. The source of medical ozone receipt the medical oxygen. Medical ozone is generated and used directly during procedure of ozone therapy by means of the special devices in future named ozone generator . In modern ozonetherapy used: ozone-oxygen mix (OOM), ozonized distilled water, ozonized 0.9% solution of NaCl (saline solution), ozonized vegetable oils.

Requirements to the source of oxygen for the receipt of medical ozone.

Oxygen for the receipt of medical ozone must correspond GOST 5573-78 (not less than 99.8% V/V of O2, is accepted on territories of SFR), European Directorate for the Quality of Medicines (EDQM), Pharmacopeia(Ph Eur), not less than 99.5% V/V of O2, Pharmacopoeia(USP), not less than 99.5% V/V of O2. — responsible, for the European, United States Pharmacopeia Convention, Pharmacopoeia(USP), not less than 99.5% V/V of O2. — responsible for the US.

Note: Lately, in connection with wide distribution of concentrators of oxygen based on technology of Pressure Swing Adsorption(PSA), the tendency of the use of such devices was set as a source of oxygen for the generators of medical ozone. In theory technology of PSA allows to get gas mixture consisting of 96% oxygen and 4% argon. A noble gas argon is contained in atmosphere in concentration near a 1 volume percent and does not enter into chemical reactions in the ozone chamber of generator of ozone, the that use of such mixture for the production of medical ozone is fully justified from the chemical point of view. However, the concentrators of oxygen applied in practice in majority cases fall short of not only to the theoretical limit for technology of PSA but also parameters declared in technical descriptions of devices. Test of four types of concentrators the productions of PRC, conducted by the enterprise of Econika, Ukraine, showed that none of these concentrators is able to give a concentration higher 89%, at the expense of gas in a 1 liter in a minute. At the expense of gas in 3 liters in a minute the concentration of oxygen on the exit of concentrators falls to 70-75% percents. Obviously, that the use of such concentrators is absolute impermissible, because unavoidable will result in ozone-oxygen mix of harmful oxide and dioxide of nitrogen. In addition, in any case, gas mix on the exit of concentrators of oxygen contains gases characteristic for the closed apartments — carbon dioxide, ammonia, sulphuretted hydrogen, oxide of carbon, steams of water, and also aerosols, lythosols, dust, microorganisms and ect. self-weighted in mid air . It should be noted also, that the percentage of oxygen goes down on the exit of concentrator, in time. So the concentrator of oxygen providing 96% maintenance of oxygen at the beginning of exploitation inevitably will bring down the level of oxygen to 70-80 % after a 5000-10000 hours of work. The rate of decline of efficiency of concentration of oxygen depends on humidity of air, maintenance of carbonic acid gas and row of other out-of-control parameters of air environment. On this basis, it is necessary to consider impermissible the uncontrolled use of sources of oxygen using technology of PSA. On occasion the use of concentrators of oxygen for the production of medical ozone, it can be approved. For such application there can founding be only a presence of the certificated equipment of providing to the not barter what 96% concentration of oxygen, thus total maintenance of oxygen and argon must make no less than 99%. Except it the concentrator of oxygen for the receipt of medical ozone must have on an exit consistently united gas-mask and bacterial filter. The concentrators of oxygen are confessed by suitable for the receipt of medical ozone must checked up by the organs of standardization not rarer what one time in half-years.

Requirements to materials used in the generators of ozone :

All materials are used in pipelines and commuting and measuring apparatus of ozone generator must be executed from ozone-rezistant materials, to that glass, quartz, fluoroplastic(teflon) and austenitic sorts of stainless steel (Austenitic, or 300 series), belongs only containing no less than 18% chromium and 10% nickel. Use of silicon rubber, polypropylene and other plastics, in pipelines ozone is shut out.

Requirements to materials and device of reactors for the receipt of OOM

OOM can be got by an electrochemical or photochemical method. An electrochemical synthesis of ozone in a barrier digit is possesses alongside decision advantages that consist in :

Wide range of the generated concentrations of ozone from 0.05 to 5 by volume percents.
Complete absence of admixtures in ozone-oxygen mix
Longevities and invariability of descriptions of ozone chamber.
Gainful process of synthesis of ozone.

Type of is recommended to use the generators of ozone based on the use of double midfrequency barrier discharge.

The standard of reactor for the synthesis of medical ozone is a ozone chamber is coaxial consisting of two cylindrical metallic electrodes coated with a dielectric layer and split the gas gap, in which the electrochemical synthesis of ozone. As an dielectric quartz, borosilicate flowed or ceramics on the basis of Al₂O₃, SiO₂, can be used. The use of flat cells is considered acceptable for ozone reactors, provided that the design of the discharge chamber eliminates the interaction of plasma with materials providing sealing chamber.

The use of other types of dielectric coverages is forbidden .

Use of the reactor is strictly prohibited in the embodiment in which the metal surface of one or both electrodes of the discharge chamber is directly adjacent to the ozone-oxygen mixture!

Warranty tenure of employment of reactor must make no less than 10000 hours.

Requirement to the control and measuring apparatus of generators of medical ozone

Professional ozone generators must provide the exact values:

The concentration of ozone in the OOM;
The gas flow rate or a specified amount of OOM;
The time of the procedure.

In accordance with it the professional generators of medical ozone must have

Spectrophotometric measuring device of concentration of ozone in OOM in a range 0.5-100 mg/litre with a relative error no less than 10% in all range of measuring.
Pressure meter in OOM in a range 0.01-0.5 barins with a relative error no more than 10% in all range of measuring, for adjustment of measuring device of concentration of ozone in OOM
Measuring device of flow or metering device of OOM with a relative error no more than 10%.
Timer

Note 1: Most of generators getting wide distribution in modern ozone therapy it is founded does not have a spectral measuring device of concentration of ozone. Setting of concentration of ozone in OOM produced on the basis of, the so-called, «plant calibration» that envisages periodic (usually 1 one time in a year) verification and adjustment of dependence between the productivity of reactor of ozone and concentration of ozone on the exit of reactor. Use of such method of task of concentration of ozone in OOM is very inexact on next reasons:

Productivity of reactor and concentration of ozone in OOM finds out strong and nonlinear dependence on the temperature of discharge chamber, and from the temperature of air.
Productivity of discharge chamber depends the strongest character on the presence of admixtures in oxygen, including from humidity of oxygen, that appropriately rises at the decline of pressure of oxygen in a cylinder with medical oxygen.
Productivity of discharge chamber, especially in case of the use of unprotected metallic electrodes, goes down gradually.

Conducted of «Econika», Odessa, Ukraine estimation of bias error of task of concentration of ozone in OOM generated by the generators of ozone using principle of «plant calibration» showed that rejections supposed on «plant calibration» and by the real values of concentration of ozone in OOM is arrived at by 70%. On this basis, we consider that the use of devices of not having built-in measuring devices of concentration of ozone, maybe only on condition of presence for the ozone therapist of additional measuring devices of concentration of ozone in OOM.

Note 2: Efficiency of number of technique of ozone therapy depends of fundamental character on the rightness of setting of concentration of ozone in the distilled water or salt solution. The concentration of ozone in a water environment finds out strong dependence on a temperature and presence of the not controlled the organic admixtures. Because of it, realization of procedures with the use of the ozonized water solutions must be necessarily accompanied by control of concentration of ozone in a water environment.

Requirements to safety and quality of generators of medical ozone

The generators of medical ozone must conform to the requirements by the produced national legislation produced to the medical technique.

Generators of medical ozone produced in every certain country admitted to use in medical practice after the procedure of technical and clinical tests of medical technique and receipt accepted in this country in the public permissive organs of the state testifying to registration of equipment as a medical device.
Generators of medical ozone, brought in every certain country on an import must pass state registration as a medical device. An order and rules of certification of generators of medical ozone are determined by a national legislation related to the certification of equipment intended for application in medical practice.
Gaseous ozone, is high-toxic connection, presenting a danger as for a medical personnel so for a patient. The use in medical practice of home-made and not certificated generators of ozone is categorically forbidden.

General requirements to the generator of ozone on the whole:

Successful practice of application of generators of medical ozone, possible on condition of observance of the requirements given above to the generators of ozone and:

Providing the enterprise-manufacturer of warranty maintenance of equipment on a term no less than 2;
The presence of at least one service center within the country in which the supply of equipment;
Warranty and post warranty support of user by awaiting-parts and expended materials necessary for the in good condition functioning of equipment.

Classification of generators of medical ozone.

Taking into account the considerations parameters of present at the market generators of ozone given above, and also coming from the necessity of presence of criteria for the skilled estimation of equipment for ozonetherapy, next classification is rational on next signs:

Generators of medical ozone of 1^st level

Must provide possibility of implementation of all procedures of ozonetherapy indicated in Madrid protocol in full, at complete control of all parameters of procedure, that provides for :

Productivity on ozone, no less than a 4.8 grams per hour, during a maximal concentration no less than a 80 mg/of liter.
Presence of built-in measuring device of concentration of ozone in a gas and water environment. Measuring limits in a gas environment 0.5-100 mg/ liter (relative error no more than 10%). Measuring limits in a water environment 0.1-30 mg/liter (relative error no more than 10%)
Presence of self-adjustment of flowrate of OOM or metering device of the set volume of OOM

Generators of medical ozone of the 2^nd level

Must provide possibility of implementation of all procedures of ozonetherapy indicated in Madrid protocol in full, at partial control of all parameters of procedure, that provides for :

Productivity on ozone, no less than a 4.8 grams per hour, during a maximal concentration no less than a 80 mg/per liter
Presence of built-in measuring device of concentration of ozone in a gas. Measuring limits in a gas environment 0.5-100 mgs/of liter (relative error no more than 10%).
Presence of self-adjustment of flowrate of OOM or metering device of the set volume of OOM

Generators of medical ozone of the 3rd level

Must provide possibility of implementation of greater part of procedures of ozone therapy indicated in Madrid protocol, at partial control of all parameters of procedure, that provides for :

Productivity on ozone, no less than a 1 grams per hour, during a maximal concentration no less than a 50 mg/per liter.
Presence of built-in measuring device of concentration of ozone in a gas. Measuring limits in a gas environment 0.5-100 mgs/per liter (relative error no more than 10%).
Presence of self-adjustment of flowrate of OOM or metering device of the set volume of OOM

Generators of medical ozone of 4th level

Must provide possibility of implementation of greater part of procedures of ozone therapy indicated in Madrid protocol, at complete or partial control of all parameters of procedure by means of additional measuring equipment, that provides for :

Productivity on ozone, no less than a 1 grams per hour, during a maximal concentration no less than a 50 mg/per liter.

Note 1: Generators of medical ozone, not having intrinsic of measuring of concentration of ozone in OOM, not dependency upon the productivity and another additional properties, are classified as an equipment of fourth class.

Note 2. Use of generators of ozone of fourth class without the additional measuring devices of concentration of ozone in OOM characterized as violation of modern requirements to safety of realization of procedures of ozone therapy.