AX series

Ethylene Oxyde Gas Sterilizers

Introduction Guide

Sparster Medical Dae

34/822-B, SriMoolam, PPN Nagar, Beena Anchumana Road, Edappally,Cochin-682024, Kerala, India

Tel: +91 484 2349496. Email: illuzpar@yahoo.co.in

AXIS
ETHYLENE OXIDE GAS STERILIZATION SYSTEMS ETHYLENE OXIDE (C2H4O)- Technical data

Healthcare facilities worldwide use Ethylene oxide sterilization to process sensitive instruments which cannot be adequately sterilized by other methods. EO, a potent, anti-microbial agent, can kill all known viruses, bacteria and fungi, annihilating even the most sterilizationresistant types of microorganisms, bacterial spores. Tough on microbes, ethylene oxide still treats most medical materials gently, even with repeated use. The ability to seal items in all-plastic packaging permits sterility maintenance for an indefinite period following gas sterilization.
EO is a tiny molecule in which two carbon and four hydrogen atoms are joined to one oxygen atom in a highly strained ring. Because of the chemical's very low boiling point (10.4C), it becomes active at room temperature. It vaporizes and permeates rapidly through packaging, dissolving in substances like plastic and rubber. EO readily kills all types of microorganisms under ordinary atmospheric conditions. Its fragile molecular bonds allow it to quickly react with a wide variety of compounds. The resulting chemical reaction is called alkylation. As with any other sterilization agent, ethylene oxide must be used carefully. Because ethylene oxide is a toxic substance, users must pay attention to correct usage guidelines to avoid adverse effects for operators or patients. Since the gas actually dissolves in porous substances, aeration is required after sterilization to remove residues. Because pure ethylene oxide is flammable ether, care must be taken to prevent its ignition. Instruments which are frequently Gas Sterilized: Instruments frequently gas sterilized in healthcare facilities include: Fiber optic endoscopes, surgical telescopes Ophthalmic instruments Plastic instruments (e.g., specula, syringes) Anesthesia masks and circuits Rubber and plastic tubing (e.g., catheters) Electrical equipment (e.g., drills, pumps, motors) Respirators and inhalation therapy supplies Surgical staplers/staples, sutures, sharps Some of these items can be sterilized using autoclaves, but the high heat, moisture and pressure of the process often causes rapid deterioration in their quality. Many plastic instruments such as speculi can be reused almost indefinitely when they are gas sterilized. Similarly, fiber optic endoscopes may be resterilized with gas, without any adverse effect.

Axis General Information

AX series Ethylene Oxide Gas Sterilization equipment with trademark of AXIS are fully automatic equipments, for sterilization of all kinds of plastic, rubber, sensitive, metallic, mechanical and electromechanical medical and surgical materials and laboratory equipment, resistant or nonresistant to heat, by using ethylene oxide (C2H4O) gas, an antibacterial agent, in 54C, ambient temperature.
The most superior aspect of the device is the fact that it has a high quality, durable configuration that is formed by the combination of minimum number of components which ensures a long term fault-free operation, reducing the downtime to a minimum. AXIS Ethylene Oxide Gas Sterilizers must be used by qualified hospital staff or authorized people. The sterilizer has a touch screen of 204x150 mm on it. Thus, entering order inputs, viewing warning messages and monitoring the operation modes is possible. Information regarding sterilization, such as period, time, function surveillance, documentation and error types, can be printed out from the miniprinter mounted on the device. Furthermore, it is possible by means of an external modem to connect to the device from the Internet to update programming monitor the system. It can be connected to a server via Internal RS232 connection port. It has adequate memory to store the reports of sterilization processes performed for one year. The data can be downloaded or transferred as required by the user. Negative Pressure: All over the world, especially under the leadership of the Western countries, negative pressure operating systems are used in EO gas sterilizers. The aim is to keep the inner part in which EO is diffused under constant negative pressure with regard to the external user environment in which human beings are present so that any possible EO leak would not permeate to cause the toxicity levels to become hazardous to the users. AXIS Sterilizer has been produced in accordance with this principle. The inner tank is always under constant negative pressure with regards to the external environment. Control systems perform tests constantly to verify and monitor the pressure inside the sterilization chamber during the entire operation. Even the smallest gas molecule that comes out of the Liner Bag is transferred to the outlet pipe and formation of any toxic level in the environment is prevented. Thus, the sterilized materials can be taken out of the sterilizer and new materials can be put in during the sterilization operation itself. Material Loading: There are no limitations regarding the placing of the packaged materials in Liner Bag. The only thing to be careful about is the fact that there should be at least 3 cm of distance between Liner Bags. Visual and audible monitoring of the operation of the device is possible during operation. Mounting of the Device and Mounting Rules: AXIS Sterilizer does not require any pressured air, water or drainage. It only needs a 220V earthed electricity socket point and a hole in the wall/window through which the outlet pipe of 6-cm diameter can be connected to the atmosphere (Ventilation shaft). Control System of the Device: AXIS brand AX series Gas Sterilizers can operate on 24-hour basis with fully automatic PLC microcomputer (PLC: Programmable Logistic Computer) system with an has an integrated printer for documentation and integrated touch screen on which each sterilization process can be monitored separately, order inputs can be entered, warning messages can be viewed, and the operation modes can be monitored.

Maintenance, Service, Repair: AXIS EO Sterilizer is produced with the intention of trouble-free operation for many years. In order to perform technical service works easily and to solve problems at the earliest, the components that have the highest possibility of high wear and tear are chosen as socket type. Thus, replacements can be made without any tool and incorrect electrical connections are avoided. There are no screws on the top cover of the device and it is inserted press-button type, which can be opened manually. All the spare parts are especially stocked by the manufacturer and can be delivered quickly upon request.

1. DEFINITION OF THE EQUIPMENT

This is new generation Sterilization equipment, which provides all requirements for Eto Sterilization in a self-contained package. Its modular design brings with it the advantages of practical performance, maximizing capacity utilization, low gas consumption, with the added advantage of negative pressure, which provides additional safety to the users and fully computerized user interface. Thanks to its new technology, the needs for infrastructure such as pressurized air, water, vacuum line, drainage channels needed by conventional gas Sterilization equipment have been remove. One of its advantages is the ability to add or remove materials modularly during the entire sterilization cycle (Staggered loading facility). This due to the active negative pressure system, which maintains the atmospheric pressure, in the sterilization chamber, at a level, which, is lower than the atmospheric pressure in the immediate surrounding environment, during the entire sterilization cycle. AXIS uses cartridges containing 100% ethylene oxide gas for sterilization. it maximizes the sterilization safety. AXIS gas consumption is only 1/10th of its competitors. Each gas cartridge contains 11 grams of Ethylene Oxide. Thus, user and system safety increases, low amount of gas is consumed and environmental pollution reduced. Aeration after sterilization is performed in the same cabin, thus residual ethylene oxide leftovers are removed, without the gas permeating to the user environment. The standards and specifications of the equipment are as follows: The equipment is manufactured in accordance with the following standards: AAMI (Association for Advancement of Medical Intrumentation) ST 41: 1999 European Norm EN 550: 2001 The equipment and its cartridges are certified by international EN ISO 13485 Trkak accredited CE quality cerficates (Trkak is the authorized nodal agency for CE certification in Trkey If the sterilization temperature is 54 C Sterilization time : 1 hour (minimum) Ventilation time : 12 hours (minimum) If the sterilization temperature is 38 C Sterilization time : 4.5 hours (minimum) Ventilation time : 36 hours (minimum) (Based on the criteria mentioned above, a working sterilization cycle of 16 hours (1-hour preparation, 3 hours sterilization, and 12 hours ventilation) is recommended. Shortening of the time cycle or decreasing the sterilization temperature may negatively affect sterilization and user safety, and hence, have been left out of the operators control.) Shortening the cycle time leads to incomplete aeration and ethylene oxide residuals in the sterilized materials.

Equipments furnace is under negative pressure throughout all stages. Therefore, any gas leakages that may occur does not affect the user environment, but are discharged rapidly through the ventilation shaft. Sterilization is achieved through various components, used as disposables in the sterilization cycle, which is supplied as a kit, and each kit includes the following: a. 100% Ethylene oxide gas cartridge b. Liner Bag c. Humidity chip d. Dosimeter Instruments to be sterilized are placed into the Liner Bag together with the gas cartridge, humidity chip and dosimeter, and sealed. Liner Bag is a special gas diffusion membrane, and is made of a gas and air permeable material. It gives the sterilization gas to the outer milieu and performs the aeration in same chamber. AXIS enables to discharge 11-grams gas within 3 hours via slow release. Liner Bag forms the secondary layer of protection to the user environment, different Liner Bags make the sterilization cell of the equipment. Users are likely to be exposed to toxic levels of gas when opening equipments lid in the conventional sterilization equipment. In AXIS even the sterilization room that is ventilated out of the equipment toxic level of the gas does not cross the safety limits determined by OSHA. In addition, test results report that humidity homogenization is in ideal diffusion position, and is stable during all sterilization process. However, in conventional Sterilization equipment humidity level in the cabin, heated by a resistance, decreases with a high acceleration, steam valves are opened intermittently, thus tries to balance the humidity level. Humidity chip provides humidity needed for sterilization, and includes pure water. (Dosimeters are integrator chemical dosage indicators which gives results based on biological indicators, and controls the four basic elements of sterilization (temperature, time, gas saturation and penetration, humidity rate), and does not change color as long as one of these parameters are not at the optimum level during the entire sterilization cycle.) The most important advantage of the equipment is that it brings together the optimum requirements for sterilization in a self-contained, modular, ergonomic, user friendly and economic package, at a very low cost of ownership. The user interface is kept simple and user friendly, that increases the comfort level of the operators. Even the start and shut down of the equipment are performed by one touch operation. Operation settings are calibrated at the factory and hence, are constant. Thus, sterilization hazards through unintended changes in the settings are avoided. AXIS is c made of quality materials. Its inner layer is made of 316-quality stainless steel, while the outer surface is covered with electrostatic oven powder paint.

2. THE ADVANTAGES OF THE EQUIPMENT

# Safest EO Gas sterilizers-Attached with Axis scrubber, the gas neutralization system, which will convert the Residue Ethylene oxide gas to carbon-dioxide and releases to atmosphere, thereby ensuring environment protection.
1. The equipment is totally self-contained and hence, there is no need for compressor, pressured air, waters and drainage in AXIS gas sterilizers. Also, the complications and problems that are caused by these sources are avoided. 2. Equipments cabin is always under negative pressure. In Sterilization equipment working with positive pressure there is risk of gas leakage permeation to the user environment and also risks due to the presence of the pressurized components are avoided due to the active negative pressure system of the AXIS.

3. Ethylene oxide in 100 % concentration is used for definite sterilization. Thus, stratification caused by carbon-dioxide mixed to ethylene oxide in several concentrations and sterilization losses are avoided. 4. As it gained widespread acceptance in the entire world, the objective of minimizing the risks of ethylene oxide leakage and environmental pollution is achieved by decreasing the amount of gas consumed. Gas quantity used in each cycle in conventional systems is 100 250 grams, and in AXIS, it is 11 grams. 5. While the conventional systems release 100 250 grams of gas within 10 seconds to the outer sterilization environment, AXIS Eto cartridges are designed to release 11 grams of gas within 3 hours as slow release, thanks to its gas diffusion technique. Thus, toxicity levels in the user environment are significantly reduced and the safety limits determined by OSHA are not exceeded. . In conventional systems the remains of the gas are canalized to the sewer system. Such a situation rises reverse diffusion risk of the gas for the users from the WC and lavatories. Though there are certain claims that passing it through certain liquids neutralizes the gas, these cannot be authenticated. As a standard, catalytic converter disposer equipments should be used to burn the gas, since there are no sensors or any control system to follow the gas status after the so-called neutralization, in the conventional sterilization equipment. 6. The most important advantage of the equipment is bringing optimal requirement of the user together and presenting strong and durable structure with high quality, to provide a trouble-free operation without risk of breakdown, and reducing equipment downtime needed to the minimum. This is significant, as in conventional sterilization equipment, frequent breakdowns and operation postponements, treatment delays are natural due to their complicated structure like heavy furnaces, plenty of medical equipment, apparatus, electrical equipment, pressured air lines, water tanks and special drainage costs. There is no requirement for any water, pressurized air, water, vacuum or drainage cost in AXIS. 7. Thanks to Liner Bags, it is possible to add materials packaged in separate Liner Bags, if there is an accumulation of materials for sterilization, during the entire sterilization cycle and perform modular operation. The big touch screen with colored display enables the operator to follow up the concurrent sterilization stages of each group online. 8. The user and communication menu of the equipment, including the integral printer, which performs reporting, and documentation functions, is English. Thus, it is friendly for all the staff, whatever its education level is. Furthermore, one key logic that simplifies the operation makes the use very practical. 9. Thanks to long Catheter Liner Bags, it is possible to sterilize GKDC catheters up to 177 cm in straight position, without deformation. 10. The equipment is easy to move and to install. There is no need for compressor, pressured air, drainage, water, vacuum etc. for installing the equipment. An electrical outlet and opening a hole in the wall or window to enable gas release pipe (5 cm diameter) to pass through will be sufficient. It is a procedure to prepare EO sterilizer chambers separately, ventilating them by aspirator and to place them in the upper flats of the building. 11. The equipment and its cartridges are certified by international EN ISO 13485 for direct medical product safety and Trkak accredited CE quality cerficates. The cartridges are the only ones that have CE certification. 12. Equipments furnace is continuously washed with 1000 lit / min air flow during ventilation. This value is only 1/10 of the limits envisioned by OSHA limits concerning EO circulation. 13. Since gas diffusion systems do not need high vacuum before the sterilization, sensitive materials are not likely to be damaged under high vacuum. 14. All of the operations and controls are being performed through an internal microcomputer. It is possible to transfer data to the computer, to follow up and control the operation through internet via modems, thanks to the RS232 port.