Safety Aspects of Ozone Therapy

Every doctor using ozone therapy must be sure of its safety, thus there must be no doubt about the purity of delivered ozone/oxygen gas mixtures for medical use (they should be contaminant-free).

We consider this problem as very important. It is a fact that after approx. 100 hours of continuous operation owing to the electrochemical erosion of the ozonization chamber walls and electrodes some of available ozone generators deliver an ozone/oxygen gas mixture contaminated by impurities (calcium, aluminium, silicon, magnesium, copper etc) in concentrations considered as dangerous for the health that however can become evident even some months or years after the treatment. This claim is valid through the investigation of the upper layer taken from the ozonization chamber wall. There are only two possible reasons for the products which were found out on the wall:

1. Destruction of the electrodes (the discovered products are equivalent to the materials of electrodes);
2. Fine contaminants possibly containing in oxygen which during the ozonolysis can be converted into toxic products.

A decrease in the ozone production can be considered as a starting point for destruction of the ozonization chamber wall (after approx. 100 hours of continuous operation). The so-called "traditional" ozone generators should be used very carefully, particularly for parenteral ozone therapy in the form of intravenous infusions of ozonated saline that can serve as ideal medium for fine contaminants.

Parenteral methods of ozone therapy are safe only if the ozone generator delivers pure contaminant-free medical ozone. Each medical ozone generator should be equipped with a filter for extra purification of oxygen used; purity of delivered ozone/oxygen gas mixtures should be guaranteed by the manufacturer through available test protocols, the same is about accuracy in maintaining the chosen ozone concentration (not worse than 10%) and great operation resource (durability) of ozonization chamber (without any decrease in the ozone production and without any change in ozone concentration accuracy) for at least 2000 hours of continuous operation.

There is no definite opinion at this point. Oxygen produced by these devices very seldom reaches the purity of 95% and higher, and we don not know whether the remaining 5% of content would not be dangerous due to electric synthesis in the ozonization chamber or interaction with ozone.

As you know, medical ozone generators require the use of medical oxygen referred to oxygen gas with guaranteed purity of 99,9% and higher. Anyways, we do not mind the use of oxygen concentrators for external i.e. local methods of ozone therapy.

Our previous experience has shown that oxygen used can contain micro-quantities of technical oils, thus each ozone generator intended for medical use should be equipped with a filter for extra purification of oxygen that inhibits the introduction of technical oils possibly containing in oxygen into the ozonization chamber. During the ozonolysis technical oils can be converted into dangerous toxic products (fatty acids, ketones, aldehydes etc).

Within a long operation time of ozone generator great volumes of oxygen are conveyed through the ozonization chamber (within 100 hours of operation in case of saline ozonization at a flow-rate of 1 L/min approx. 6000 L of oxygen are conveyed through the ozonization chamber), the ozonization chamber gradually becomes covered with an oily layer, and the doctor cannot be sure of the quality of gas mixtures delivered, thus extra purification of oxygen through a filter at the inlet of ozone generator is a reasonable step.

It is puzzling to us that some manufacturers of medical ozone generators use the parameter "Ozone production per 1 hour". This parameter was obviously taken from the ozone technology for water treatment, but in the medicine the ozone production should be adjustable at least per 1 min

Before the New-Generation of medical ozone machines characterized by unique accuracy in maintaining the chosen ozone concentration and a uniquely wide range of ozone concentration adjustment, the doctors using ozone therapy were conditioned by the "traditional" types of ozone generator with very low accuracy in maintaining the chosen ozone concentration (worse than 40-50% as a rule) and a narrow adjustable range (1 : 15 - from 1 mg/l to 15 mg/l). The ozone concentration accuracy of +/-5% …+/-10% ensures a reasonable, predictable and dose-related therapy.

The high accuracy in maintaining the chosen ozone concentration allows using ozone like any other generally accepted medicine. That might have been one of the obstacles for wide spreading of ozone therapy. Nevertheless, all advantages of the Medozons machine do not influence its price, but this is a fact that there are many medical ozone generators on the market being much more expensive, but inferior in technical properties as compared with our machines.

We can explain it with the Medozons-BM:

1. Range of delivered ozone concentrations (50…10 000) mcg/L. This parameter means that the machine is able to maintain the chosen ozone concentration within the available range with accuracy not worse than +/- 10%: 107 mcg/L or 5671 mcg/L.
2. The parameter "Range of ozone concentration adjustment (1 : 9950)" means that the machine is able to provide 9950 values/gradations of ozone concentration with accuracy +/-10% that characterizes the depth of adjustment.
3. The range of selecting the dose of ozone characterizes a wide range of ozone dosage adjustment from 0,25 mcg/L to 10000 mcg/L with accuracy +/-5%, at an ozone/oxygen flow-rate of 0,25 L/min adjustable by step 0,25 mcg; 0,5 L/min - 0,5 mcg; 1 L/min - 1 mcg.

So, medical ozone generators of Medozons series are able to produce guaranteed pure medical ozone and dose it exactly, with regards to technical and medical features they are the best ones within Russia and have no analogies worldwide! We are sure that the above parameters today considered as unique tomorrow will be the new standards of ozone therapy.

Manually setting of oxygen flow-rate by means of regulator may induce a considerable decrease in ozone dosage accuracy (the dose of ozone = CO3 x O2/O3 flow-rate x treatment time) due to possible oxygen pressure fluctuations (in oxygen tank or any other oxygen supply system) or any change in gas tract resistance.

In medical ozone generators of Medozons series oxygen flow-rate delivered to the ozonization chamber is automatically stabilized at the given level regardless of influence from outside, the automated stabilization system of oxygen flow-rate is reliable even in case of considerable pressure fluctuations that ensures a dose-related therapy. The automatic gas supply system is tested by the manufacturer for accuracy in maintaining the chosen oxygen flow-rate. We are convinced that the fixed O2/O3 flow-rates do not limit, but widen the range of ozone applications, most of doctors perform ozone therapy at a flow-rate of 1 L/min, but using a flow-rate of 0,5 or 0,25 L/min it is possible to successfully perform intracavitary ozone therapy (in gynecology, urology etc).

In medical ozone generators of Medozons series like Medozons-BM and BM-02 you can see a different functional principle of the ozonization chamber that ensures a wide range of ozone concentration adjustment (from 50 to 10000 mcg/L) with high accuracy in automatically maintaining the chosen ozone concentration not worse than +/- 10%, in fact, the actual accuracy tested by the manufacturer is not worse than +/- 5%. The attested accuracy is valid for at least the same time as the specified durability of the ozonization chamber before the scheduled prophylactic service (2000 hours of continuous operation or about 5 years of usage). The latest device Medozons-System has a built-in measurer of ozone concentratrions.