According to the report on state sanitary and epidemiological examination, presented by the Ukrainian Ministry of Health and confirmed by the Chief sanitary doctor (reference № 05.03.02-07/46770 as of 02/10/2006), the above-mentioned steriliser meets all the requirements of the sanitary legislation of Ukraine and it is recommended for intended application.

The expert report (reference 3/8А-8795 as of 27.09.2006) on the clinical tests, conducted by L. I. Medved Institute of ecological hygiene and toxicology, approves the application of the steriliser as medical equipment that complies with the health and safety requirements of the General methodological guidelines for toxicological and hygienic appraisal of production in conformity with the State standards of Ukraine (reference 3798-98 as regards medical electrical appliances).

The report on the technical tests by the State test centre at the INSTITUTE METROLOGY Educational and scientific centre as of 06.07. 2006 has confirmed the compliance with all the normative requirements for electrical safety, earthing resistance and insulation strength, leakage current, sound power level, resistance of the apparatus and its case to vibration strain, multiple disinfection, resistance to climatic factors and sinusoidal vibrations, to radio frequency interference and electrostatic discharges.

The report on the State sanitary and epidemiologic examination by the Ukrainian ministry of health (reference № 05.03.02-07/46769 dated 02.10.2006) states the conformity of the steriliser technical standards (reference 33.1-30881586-002:2006) to the effective sanitary legislation of Ukraine.

The expert report on the clinical trial tests conducted by the Institute of surgery and transplantology at the Ukrainian Academy of medical sciences (reference № 30/06 as of 19.04.2007) confirms its compliance with the intended medical application as well as the fact that its specifications satisfy the present-day medical and technical requirements to the equipment of the given class. It also attests highly effective sterilisation, operational safety and expedience of its further application.

The report (reference №556-06 as of 20.10.2006) of technical acceptance tests by the Ukrainian Medical certifying centre at the Ukrainian Ministry of Health certifies that the steriliser in question has successfully undergone all the relevant tests.

The report (reference № 61014 dated 18.01.2012) on the qualification tests carried out by the State ELECTROMASH test centre at the KHARKIVSTANDARDMETROLOGY State enterprise attests to the compliance of the technical specifications with all the necessary regulations on electrical safety and electromagnetic compatibility, environmental protection as well as sanitary and fire-prevention legislation.

The steriliser may be applied in treatment facilities, sanatoria, polyclinics and other medical establishments as well as in field military surgery and emergency medicine settings.

The development of modern medical equipment requires new effective approaches of low temperature sterilization. Surgical instruments with micron sharpening, endoscopic and laparoscopic equipment, various catheters (with the application of polymers, optics, adhesive joints), together with plastics used for internal and external prosthetics in traumatology, stomatology, facial surgery, etc., which do not stand high temperature treatment with air or steam under pressure.

At present treatment-and- prophylactic institutions of Ukraine, Russia and those abroad use liquid and gas methods of low temperature sterilization based on highly toxic chlorinates, ethylene oxide, formaldehyde, hydrogen peroxide, the application of which is connected with the following problems:

• long period of sterilization (4-6 hours);
• difficulties caused by utilization of reagents and their unfavorable influence on environment;
• necessity of removing reagents remaining from instruments and equipment, cleansing in sterile water or long-time aerating with sterile air;
• unfavourable influence of different sterilizing agents and their derivatives on the health of the medical personnel, involved in the sterilisation procedures.

Gas sterilisers on the basis of ethylene oxide (EO) have been used more than forty years to sterilise thermo- and- moisture sensitive devices. Recently EO has been acknowledged as potentially mutagenic, neurogenic and dangerous in terms of fire and explosion hazard as well as being carcinogenic. Occupational Safety and Health Administration (OSHA) has imposed rigid requirements in respect of the identification of EO in the air and its application. Besides, chlorofluorocarbonites (CFCs), being dissolvents of OE-CFC, destroy the ozone layer. Due to all these factors, many hospitals were forced to abandon the application of EO-sterilisers.

Thus, using liquid and gas methods of low temperature sterilization on the basis of 
highly toxic chlorinates, ethylene oxide, formaldehyde, hydrogen peroxide is connected with long period of sterilization, difficulties caused by the utilization of reagents, the necessity of removing sterilizing agents remaining on the instruments and cleansing in sterile water or aerating with sterile air and the unfavorable influence on the health of the medical personnel.

The advantages of ozone steriliser:

• low technological temperature of sterilization up to 40°C, fully automatic operation and control, microprocessor control;
• reliable in service, safe, economical, carefully processes expensive medical devices and instruments, allows for the sterilisation of thermo-sensitive materials, and it is easy in use and service;
• large volume of the sterilization camera – 100 litres;
• energy-saving method requiring no service materials, steam supply, three-phases voltage at 360 V;
• ready-to-run, requiring no installation and fitting;
• high quality sterilization, confirmed by the reports on technical, sanitary-hygiene, toxicology, preclinical and clinical trials in different institutes, scientific centers, hospitals of the Ukrainian Ministry of Health, the Ukrainian Academy of medical sciences and the National Standards of Ukraine;
• short sterilizing process, the full sterilizing cycle is 120 minutes;
• due to its sterilization and technical characteristics this environmentally-friendly steriliser greatly surpasses in quality other ultra-violet sterilisers, dry-heated air sterilisers, steam autoclaves, liquid and gas sterilisers. The bactericidal effect of the quartz radiation during 60 minutes is equal to the bactericidal effect of the 3-minute ozone sterilisation;
• the highest ozone sterilisation dose of 2400 gr(min./m? in comparison with other ozone sterilisers, produced by other manufacturers (that of the best foreign ones constitutes not more than 1200 gr(min./m?), which provides for the possibility of sterilising both packed and unpacked tool kits wrapped in special bags/packets for gas sterilisation; 
• the lowest price unlike other ozone sterilisers, produced by other foreign manufacturers;
• compulsory ozone circulation in the sterilisation chamber ensures the high-quality sterilisation processing of hidden and internal surfaces of instruments. The presence of the additional ozone inlet connector in the chamber allows for compulsory concurrent sterilisation processing and blowing of inner long surfaces with ozone;
• no chemically stable and expensive toxic disinfectant and service materials required;
• the availability of single-use chemical indicators for express-tests and automatic devices in the apparatus to check and control the quality of sterilisation;
• possibility of installing the steriliser directly in the consulting or operating room;
• possibility of leaving the instruments in the steriliser after the sterilisation;
• for the purpose of raising the quality of sterilization, all the ozone-oxygen mixture is moistened passing through the distilled water by means of a special device; 
• safe operation, excluding any exit of ozone into the working area, which is provided by the hermetic working chamber, the highly productive destructor for decomposing unused ozone-oxygen mixture, providing the ozone concentration lower than MPC– 0,1mg/ m? in the working area;
• the net-shaped loading trays are made of stainless steel;
• high informativity of the colour LCD with the keyboard that allows for selecting and setting various operation modes; 
• easy in use and service and fully automatic process of sterilisation;
• automatic system of safety, blocking and emergency turnoff in case of operation failure or open door accompanied by a sound signal;
• no destruction of any sterilised equipment and instruments;
• no need in watering, drying or keeping in ventilating premises or degassing instruments after sterilisation;
• no harmful or ecologically dangerous emissions into the working area and atmosphere; 
• bacterial purification of the oxygen entering the sterilization chamber. When the oxygen passes through the ozone generator, the bacteria and viruses are destroyed by high-voltage discharge;
• electronic system of steriliser operation control. The inbuilt reductor of fine pressure adjustment, pneumatic valves, electronic pressure detector provide for the automatic regulation and control of oxygen delivery as well as its automatic turnoff if the steriliser is turned off;
• automatic control over ozone generation provided by the special devices and microprocessor control units. In case of inner system failure, the sterilizer turns off automatically and the error code is shown on the front panel colour LCD.  

The Institute of ozone therapy medical equipment has been awarded:

• the Diploma of the prof. G. L. Kanevskyi prize winner by the Ukrainian Society of physiotherapists and balneologists for creating the OZONE UM-80 OZONATOR (№ 15 as of 26.11.2002).
• First Diploma of the oldest in Ukraine Kharkiv medical society "For promoting the national ozone therapy and manufacturing the equipment for its administration” in 2003.
• The Expocentre of Ukraine Diploma of the International medical INMED -2004 exhibition.
• Diploma №120-104 of the International Healthprotection – 2005 exhibition of the Russian Federation in Moscow for the best development of the Universal medical OZONE-UM 80 ozonator.
• The best model in 2005 Diploma of the ХХth International SLAVYANSKIY BAZAR business-forum for the development of the Universal medical OZONE-UM 80 ozonator.
• The Diploma of the Central Expocentre Exhibition Complex (Moscow, the Russian Federation) at the International Health protection – 2006 exhibition.
• The 2007 prize-winner (together with Kharkiv National radio electronics university) and a participant in the international health protection exhibition in Hannover in the project of the Science and Technology Centre of Ukraine (STCU) and the Ministry of Education and Science of Ukraine for the development of biotechnical system of treating diseases with the help of ozone therapy and chemiluminescent express-diagnostics.
• The winner (with the institute of scintillation materials at the National Academy of Sciences of Ukraine) of the contest in 2007 held by the Ministry of Education and Science of Ukraine for the best development and manufacturing of the gas analyzer to measure ozone concentration.
• Diplomas of the ХIIIth, XIVth, ХVth, XVIth, XVIIth, XVIIIth, XIXth, XXth and XXIth International Ukrainian specialised medicine exhibitions "Health protection” in 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011 and 2012.
• First Diploma of the All-Ukrainian Association of physiotherapists, balneologists and recreation therapists for the creation and implementation of the new highly-effective medical OZONE-UM 80 apparatus in 2008.
• The Diploma of the 15th international HEALTH and LONGEVITY medical exhibition in 2009 by the Hal-EXPO, CJSC, in Lviv for the «Major contribution to the development of ozone therapy and medical equipment in Ukraine».

OVERVIEW:

To carry out low temperature sterilisation the apparatus produces medical ozone from gaseous oxygen by means of elctrosynthesis. The steriliser is has been constructed on the component basis of the leading foreign firms. We provide PC-assisted metal cutting and case manufacturing at the works as well as double coating with ozone-resistant French powder paint processed at t=200-300°С. The assembly of SMD electronic components and microprocessors is carried out on the special German ERSA automated lines in compliance with the ISO – 9001 standard. With its technical specifications the steriliser is a device of the new generation, the best in the CIS and second to none in the world. The steriliser is universal as it ensures effective sterilisation of a broad range of devices and instruments for various purposes.

KhARTRON – ENERGO Scientfic-manufacturing enterprise (the leading developer of electronic and automatic equipment, software and space-rocket hardware control systems both in Ukraine and the CIS) developed the software and systems to run all the ozonator operation modes. 

Protected by the patent of Ukraine (reference № 24146). 

Medical low-temperature ozone sterilizer is intended for the following equipment, instruments and devices:

In order to increase the ozonator operation safety, create a power reserve, improve the operation stability, extend the service life, prevent the overheating of the discharge chamber, the inbuilt automatic control systems regulate all the parameters and stop or shut down the steriliser if there are failures in operation modes or faulty actions of its operator.

With due regard for the materials used in the sterilised instruments and devices, the steriliser construction permits selecting sparing modes of sterilisation and, after they have been tested for ozone resistance and sterilisation quality in a bacteriological laboratory, permits careful, delicate and continuous sterilisation of various instruments and equipment types.  

The ozone concentration is set individually for each particular set of tools or device, taking into consideration the materials used in the sterilised instruments and devices, the country-manufacturer, and, most importantly, the results of the bacteriological washing tests of the instrument surface and internal surfaces of the steriliser after the sterilisation has been performed. The concentration levels vary within the range of 20,0?30,0 mg/l. To maintain the high quality of sterilisation, it’s advisable to increase the duration of processing the instruments with ozonised oxygen mixture if the concentration of ozone being supplied to the steriliser is reduced.

The complete sterilisation cycle lasts 120 minutes (2 hours), however, the duration of sterilisation can be extended up to 180 minutes, which permits reducing ozonised oxygen mixture concentration for sterilisation.

After the ozone concentration in mg/l, sterilisation cycle duration in minutes and the ozonised oxygen flow speed at 4 l/min have been set on the LCD, the START button is pressed, with all the set parameters maintained and controlled by the microprocessor controlling blocks and shown on the display. In order to improve the sterilisation quality, the apparatus constantly maintains the circulation of ozone-oxygen mixture, which is moisturised while running through the bottles with distilled water.

The internal tube canals of endoscopes, various devices, catheters, probes and other tools for compulsory blowing and sterilising long inner canals and cavities with ozone are connected to the ozone delivery connector inside the chamber by means of special tubes.

The steriliser features the inbuilt German destructor for decomposing unused ozone and turning it into oxygen before it is emitted into the working area. The risk of accidental inhalation impact is reduced to the minimum due to the application of the special German ozone resistant destructor, ozone-resistant materials and the pressure-tight connections.

The gas ozone method of low-temperature sterilisation ensures the sterilisation of various medical instruments either packed or unpacked at the temperature in the sterilising chamber constituting 30-40ºC.

The present steriliser allows sterilising reusable surgical instruments, hard endoscopic, laparoscopic, endo-videosurgical, microsurgical and other instruments, parts of devices and appliances made of corrosion-resistant metals and alloys, (rustless steel, titanium etc), as well as examination and surgical (otolaryngological, stomatological, gynaecological etc) instruments, objects made of plastic materials (fluoroplastic, PVC, polyurethane, polyethylene etc), medical ozone-resistant rubbers (silicone etc), polymers, epoxy resins and glass.

MAIN TECHNICAL SPECIFICATIONS:

 DESIGN and OPERATION PRINCIPLES:

The improved modernised apparatus is of desktop stationary design and consists of two separate cases (upper and lower), placed one on the other. 

The upper block contains all the pneumatic and electric high and low-voltage part, electronic system, power supply unit, systems and system controlling cards, ozone generators, LCD monitor with the keyboard for controlling operation modes, systems and devices for controlling the sterilisation process and ensuring safe operation, connectors for oxygen and outlet of ozone. The external dimensions of the upper block are 585.00 (width) х 460.00 (depth) х 170.00 mm (height). The mass – 12.0 kg.

The lower block – sterilising chamber consists of a hermetic case with the front door on special inner hinges with a special clamping handle, which ensures its tight closing. The front door provides hermeticity of the sterilisation chamber due to the ozone-resistant sealants, with the hermetic seal used at atomic power stations, which prevents ozone leakage in any operation modes. The internal dimensions of the sterilisation chambers can conveniently hold long instruments and are as follows? 570х 460х400mm, the diagonal size constitutes 710 mm. The external dimensions of the sterilisation chamber are as follows? 650.00х530.00х430.00mm. The sterilisation chamber can conveniently hold various instruments and optics on two retractable trays of stainless steel with slots. The side panel features a special device with bottles filled with distilled water to moisturise ozone-oxygen mixture and a special ozone-resistant destructor. The lower block mass is 26.0 kg.

The front panel features a blue colour LCD with the keyboard for selecting, setting and controlling different operation modes. The network cord with an electric socket, connector for oxygen, ON and OFF buttons, connectors for ozone-oxygen mixture delivery into the steriliser are all located on the rаre panel.

Sterilization is effected with high ozone concentration, produced in the ozone generator of the sterilizer from oxygen. Ozone is the strongest oxidant; it is ten times stronger than chlorine, that’s why it ruins membrane, cell-organelle of bacteria, viruses and other pathogenic microorganisms as well as fungi.  

After the NETWORK button on the rare panel has been pressed, the apparatus is turned on, heated, automatically calibrated and the blue LCD is switched on indicating that the ozonator is ready for operation. The LCD shows FLOW, OZONE, TIME, the operator can then press the SELECTION button.

If the operator presses the SELECTION button, he/she can select and set the digital values of parameters and the following ozonator operation modes: FLOW, OZONE, TIME. The selected operation parameters are indicated by an arrow on the display and allow the operator to set the following operation modes in any combination:

TIME – duration of the ozone production from 100.0 up to 180.0 minutes.

If (+) or (-) pressed either for a short time or continuously, the dogital value increases or decreases on the display respectively and the prescribed value is set. If the button is set free, the prescribed value is fixed. After all the necessary parameters have been selected and all the digital values have been set, the START button is pressed, starting the operation of the steriliser and the ozonised oxygen mixture generation. The display shows the digital values of the parameters of the device in operation: ozonised oxygen mixture flow speed FLOW – expressed in l/min., the concentration of the generated ozonised oxygen mixture OZONE – expressed in mg/l and the remaining time of operation expressed in hours/minutes with the countdown. As soon as the prescribed duration of ozone generation has expired, the timer automatically turns the apparatus off. If the START button is pressed a second time, the BLOWING function is automatically turned on that lasts for 40 minutes, during which the remaining ozonised oxygen mixture inside is additionally removed and destructed. The steriliser operation can be stopped if the operator presses the STOP button at any time. Should the oxygen delivery fail at the beginning of the operation or during its operation, the apparatus turns off automatically with the following indication on the display: ERROR: FLOW CONTROL. If the door of the apparatus is accidentally or mistakenly opened during its operation, the appliance automatically turns off with the following indication coming out onto the display: BLOCK DOOR OPEN. The apparatus also features the additional TIME functional button, which, if pressed, tells the user the exact operation time of the steriliser by progressive total.

The sterilisation with ozone within the time span of 120 minutes comprises two cycles as follows: pre-sterilising process, the sterilisation proper and the removal with decomposition of the ozonised oxygen mixture by means of the inbuilt destructors till the concentration values of the ozone contained therein are lower than the MPC constituting 0,1 mg/m3. While the steriliser is being turned on, the automatic control system checks the functionality of all the systems and launches the sterilisation cycle. 

1. Pre-sterilising cycle lasts 20 minutes, during which the air in the sterilisation chamber is replaced /ousted by the ozone-oxygen mixture. This happens in the following way: the oxygen is delivered through the specially inbuilt reductor of the fine pressure adjustment (from the oxygen concentrator or the system of centralised oxygen supply), into the discharge chambers of the ozone generator. With the prescribed ozone concentration of 20-30 mg/l (g/m3), the ozone-oxygen mixture proceeds into the sterilisation chamber out of the discharge chambers of the ozone generator. While the sterilisation chamber is loaded with the ozone-oxygen mixture, the air in the sterilisation chamber is removed through the special destructor into the working area.

2. Sterilisation proper. The very instant the sterilisation chamber has been loaded with the ozone-oxygen mixture, the 100-minute-long sterilisation cycle commences. During the sterilisation cycle the ozone-oxygen mixture constantly circulates inside the steriliser and is removed through the destructor into the working area.  

As soon as the sterilisation cycle is over, the ozonised oxygen mixture is removed from the steriliser and destructed. In order to do that, after the apparatus has stopped operating, press the START button, thus starting 40-minute-long destruction mode, the removal and decomposition of the ozone-oxygen mixture from the sterilisation chamber with the ozone concentration at the outlet of the steriliser several times as low as the PMC.

When the sterilisation is over, the apparatus automatically turns off.

The basic delivery set comprises:  

The apparatus is complete for delivery. No further furnishing is required.  

Reliable and safe hermetisation as well as packing with ozone-resistant materials of all the joints and apparatus case provide safe operation for the personnel.  

The steriliser provides various blockings and automatic control of the sterilisation process as well as electric and fire safety. With the sterilisation going on, the door is NOT to be opened without turning off the device prior to that. The operator can suspend the sterilisation cycle by pressing the STOP button or opening the steriliser door. 
Special devices control the course of sterilisation, the whole cycle is run and controlled by the microprocessor blocks, which is evidenced by the stable operation of the abovementioned devices and the indication of the operation progress of all the systems. If there are failures in operation of the steriliser inner systems or faulty actions of its operating personnel, the apparatus automatically turns off and the corresponding error code will be shown with a sound signal given at the same time.

Since endoscopic, surgical, optical and other equipment as well as various catheters are produced by different manufacturers, consequently containing parts and joints form different plastic materials and rubber of varying composition and quality, in addition to the fact that they have their intrinsic features and it’s not always possible to foresee ozone impact on them, we recommend preliminary testing their ozone-resistance levels. 

The duration of apparatus continuous operation is up to 8 hours.

The present steriliser is the only one in the world to permit selecting individual sterilisation modes with due regard for the materials used in the sterilised appliances and instruments. It also allows for delicate, careful, continuous and, most importantly, ensured sterilisation of various medical equipment and tools after the ozone-resistance tests have been conducted as well as the positive report presented by the bacteriological laboratory.  

The possibility of selecting and setting various combinations of operation parameters on the steriliser monitor (ozone concentration, ozone delivery speed and the cycle duration) enables doctors to perform reasonable, predictable, high-quality and environmentally sustainable gas sterilisation at low temperatures, while at the same time guaranteeing that there will be no damage caused to expensive equipment and instruments subject to sterilisation. 

Over 7 years of using and operating the low temperature ozone steriliser in hospitals, institutes, sanatoria, outpatient department settings and other medical facilities, the apparatus has positioned itself as reliable, safe, easy to use and operate, fully complying with the present-day medical requirements and effective sanitary legislation of Ukraine.