HYDROGEN PEROXIDE PLASMA STERILIZER

Transcription

1 HYDROGEN PEROXIDE PLASMA STERILIZER STERICOOL A160S, A160D, A160SF, A160DF, A110S, A110D, A110SF, A110DF Committed to Sterile Reprocessing Worldwide at the Highest Standard

2 Process Validation Personal and Environmental Safety Stericool sterlizer range has perfect environmental safety record. At the end of the sterilization cycle In-chamber-plasma ensures that there is no sterilant residue left on medical instruments and no residual H2O2 leakage from the sterilizer. Extensive ISO compliant half-cycle (SAL 10-6) validation tests on Stericool equipment has been conducted by an independent EN ISO/IEC 17025/20 accredited 3rd Party European Laboratory which is also certified by TURKAK Critical sterilization parameters (cell pressure, temperature and humidty; hydrogen peroxide injection; plasma power and diffusion time) are monitored in real time via dedicated sensors. Critical sterilization process data is continuously logged and can be stored for up to 12 years. Double Door, Pass-through Operation Pass-through double door option of Stericool devices perfectly satisfies zone separation requirements of modern CSSDs. Sterilization loads are delivered back to the clean room processing zone in the event of an aborted cycle. Easy Installation Stericool devices are designed to be mobile and can be easily integrated into any healthcare unit as it only requires a standard power connection (3 phase connection is optional). No extra civil work, water source/drainage, waste management, ventilation or mounting are required prior to installation. Stericool devices are simpy plug & play.

3 Intuitive GUI Sterilization process is displayed graphically on a 7 colour touchscreen display. Sterilization programs stage, duration, vacuum pressure, in chamber temperature and Sterilant usage data are displayed in real tiime. During installation and maintenance calibration rich functionality diagnostic tools can be accessed via a password entry. Pre-Conditioning 1 st Diffusion and 2 nd Diffusion Cleansing User Friendly Fully Automated Sterilization Programs Stericool range feature three fully automated programs to sterilize widest range of sensitive medical intruments One-button operation increases user productivity. The Fast Program provides shortened sterilization time for easy to sterilize large surface sterilization loads. The Standard Program is designed to sterilize general surgical instruments with single channel flexible and moderate length rigid lumens. The Advanced Program is designed to sterilize surgical instruments with long rigid lumens. Intuitive use of the graphical touch screen minimize increases system throughput and minimize operator mistakes. Intelligent System Management Stericool s intelligent system management software constantly monitors the devices performance and all cycle parameters through multiple sensors (pressure, temperature, vacuum-level, plasma and sterilant concentration) and keeps the user informed on the sterilization cycle progress and system errors. Its resident self diagnostic programs provide guidance on easy error correction and provides notice on imminent service expiration. In case of an operational error, the relevant error code is displayed on the graphical display and the sterilization cycle is aborted in an orderly manner with optional audio alarm. Stericool range can store up to 12 years of log of all activities, transferable via USB, SD memory card or TCP/IP network. Pre-Conditioning Vacuum Conditioning Plasma Conditioning H2 O 2 Injection Vacuum Conditioning Diffusion The hydrogen peroxide sterilization process requires vacuum with minimum moisture. Any humidity in the chamber is removed during this phase and low vacuum is reached. Vacuum Operation H2 O 2 Injection Plasma Conditioning Diffusion The surgical instruments are pre-conditioned with plasma which is used to (i) remove moisture (ii) enable homogenous heat distribution and (ii) provide free radicals for the sterilization. Vacuum Operation Plasma Abatement Areation Hydrogen Peroxide Sterilant (H2O2) 59%wt Stericool utilizes highly purified 59% wt concentration H2O2cartridges which are authenticated with internal RFID and/or barcode scanner. Our patented injector technology enables us to use minimum sterilant at maximum efficiency. Sterilant Cartridge Loading Bay at Front The front-load option with an automated H2O2 extractor accommodates ST240 & ST030 cartridges and requires minimal manual manipulation by the operator. T240 containers o 110Lt. units 24 (*) sterilization cycles o 160Lt. units 20 (*) sterilization cycles Sterile-Processing Cleansing Hydrogen Peroxide Injection Previously conditoned hydrogen peroxide vapor injected into the sterilization cell as a sterilization agent. Plasma Abatement The plasma at the end of the cycle, ensures that all hydrogen peroxide decomposed to free radicals and eventually water and oxygen and thus no residues left within the sterilization load 1 st Diffusion After injection into the chamber hydrogen peroxide is kept in vapor phase to enable homogenous and effective diffusion inside the lumens and cavities of the surgical instruments Optional Aeration Sterilization cell is vented with purified dry air to provide further cleansing. 2 nd Diffusion Second hydrogen peroxide injection and diffusion operation repeated to satisfy 10-6 SAL validation. ST030 containers (suitable for air freight) o110lt. and 160Lt. units 2 sterilization cycles Sterilant Cartridge Loading Bay at Side The Side-load option supports ST450 which offers even more efficient use of sterilant by providing higher number of sterilization cycles. ST450 containers o 110Lt. units 42 (*) sterilization cycles o 160Lt. units 35 (*) sterilization cycles Our Patented Dual-Mode Injector Technology Our dual mode injector technology provides users more flexibility of programs to better protect your medical instruments and provide increased sterilization efficiency at the same time. State of the Art RF Plasma Technology The homogeneous plasma distribution protects sensitive medical instruments and thus offers many advantages against uneven electrical arc plasma utilized. Data Logging, Interoperability Sterilization process validation logs may be transferred via SD memory card, USB connection or by Ethernet TCP/IP connections to any LAN or WAN network such as the Internet. (*) Total cycles per cartridge will vary with program selection

4 Sterilization Programs Fast Program Fast Program provides fast turnaround for instruments which need surface sterilization which include telescopes and rechargeable batteries for use in laparoscopic, orthopedic or ophthalmology procedures. Fast Program uses 59% wt H2O2 and has a duration approximately 29 minutes. During Fast Program Program Load is limited to 5Kg and to the upper tray only. Standard Program Advanced Program Standard program is designed to sterilize general surgical instruments with flexible and rigid lumens. Standard Program is designed to handle Single Channel Flexible Lumens/Endoscopes. Standard Program uses concentrated H2O2 and has a duration approximately 46 minutes. Advanced program is available as a installation option to sterilize general surgical instruments which has long rigid lumens. Advanced Program uses concentrated H2O2 and has a duration approximately 57 minutes. Why Hydrogen Peroxide Plasma Sterilizer? PERSONAL AND ENVIRONMENTAL SAFETY - Alternative sterilizers Ethylene Oxide (EtO) and Formaldehyde are hazardous environment and carcinogenic for humans. NO RESIDUAL TOXIC WASTE; NO HARMFUL BY-PRODUCTS - Radio Frequency Hydrogen Peroxide Plasma abatement technology facilitates outstanding personnel and environmental safety. At the end of the sterilization cycle, all hydrogen peroxide is converted into water and oxygen. RAPID THOROUGHPUT - Ethylene Oxide (EtO) and Formaldehyde sterilizers have extended sterilization cycles, 12 and 4 hours respectively. Whereas hydrogen peroxide plasma sterilizers offers rapid throughput (31minutes) hence reducing operational costs. IN-CHAMBER PLASMA - In-chamber plasma breaks down residuals on the medical equipment and contributes sterilization by generating radicals unlike the rudimentary hydrogen peroxide vapor sterilizers. Further, not all plasma sterilizers actually facilitate in-chamber plasma and therefore does not offer the same benefits EXTENDED LIFE FOR DELICATE STERILIZED INSTRUMENTS - Optimized sterilization environment for delicate, heat-sensitive, and moisture-sensitive medical instruments resulting in minimum instrument damage and lower repair costs EASY INSTALLATION REDUCES COSTS - System installation simply requires an outlet supporting V 3400W. There is no need for costly plumbing, ventilation, or monitors as the Stericool unit has no toxic waste. Easy installation means that devices can be reposition to adapt to the changing needs of the hospital. Gentler On Your Medical Equipment In the Stericool A110 and A160, the physical conditions imposed on the sensitive medical tools and instruments in the sterilization chamber is far gentler than industry leading competitors, BECAUSE OF: - Stericool is gentler on the use of H2O2 sterilant - Stericool uses more gentle patented plasma generator - Stericool offers patented low temperature dual mode (uses non-concentrated sterilant) for delicate instruments - Sterisool use industry standard temperatures - Stericool use patented accurate sterilant concentration control Models A110S / A110SF: 110 Liter H2O2 Plasma Sterilizer A110D / A110DF: 110 Liter H2O2 Plasma Sterilizer, equiped with double door for pass-through operation A160S / A110SF: 160 Liter H2O2 Plasma Sterilizer A160D / A160DF: 160 Liter H2O2 Plasma Sterilizer, equiped with double door for pass-through operation All models are available in side load or front load cartridge versions. All shipments to EU is limited to front loaded models Please refer to the Stericool Technical Specs Brochure Consumables Stericool offers affordable best quality consumables for its product range. Please refer to the Stericool Consumables brochure. Sterilants Process validation kits Chemical Indicators Biological Indicators Tyvek rolls

5 Why Stericool is the best choice? CONCENTRATED STERILANT PROVIDES THE HIGH STERLIZATION EFFICACY Water vapor molecules in a sterilization chamber compete with the sterilant molecules; therefore concentration of sterilant increases the sterilization efficacy substantially. Stericool s Standard and Advance programs employ concentrated Hydrogen peroxide for optimized process duration. EXTENDED MATERIAL COMPATIBILITY VIA DUAL MODE CONCENTRATOR INJECTOR - With patented dual mode technology Stericool offers both variable concentration and none concentration cycles thus enables widest range of material compatibility. NO TOXIC RESIDUAL; PERFECT RECORD FOR ENVIRONMENT SAFETY - In-chamber-plasma ensures no sterilant residue is left on medical instruments. Th in chamber plasma and in-line efficient catalytic converter ensure that there is no residual H2O2 leakage from the sterilizer. ISO COMPLIANT TEST VALIDATION FROM ACCREDITED LAB - Stericool s sterilization processes are validated to 10-6 SAL (Sterility Assurance Level) by an ISO/EN accredited European laboratory. Stericool provides ISO spec half cycle tests during installation. WORLDWIDE OPERATION INCLUDING INSTALLATIONS IN DEMANDING MARKETS - Stericool has gained wide acceptance in the most demanding markets with installations in reputable hospitals in Europe, MENA and Far East. COMPLETE RANGE OF AFTER SALES SERVICES - Stericool and its worldwide well trained distributor network provide support, on-site services and regular preventative maintenance. QUALITY - Our products are manufactured under continuous quality control to appropriate medical and product quality standards with EN ISO 13485:2012, EN ISO 9001:2008, and full CE (EMC EN , EMC EN , and LVD IEC ) certification. GOA Teknoloji A.S Ivedik OSB 1436.Sok No:14 Ostim Yenimahalle ANKARA TURKEY info@stericool.com Tel: Fax: