From start to dry in the blink of an eye. STATIM® Autoclaves.
Transcription
ll y fractionated vacuum steriliser HYDRIM M2 HYDRIM L110 washer/disinfector 306 ✓ nt Fu BRAVO N1 0 E 26793_SciCan_Opthamology_Layout 1 16/01/12 8:08 AM Page 1 C o m p li a Bravo17 (220-240V, 10A 50 Hz, Printer) Bravo17V (220-240V, 10A, 50Hz, Printer) Bravo21V (220-240V, 10A, 50Hz, Printer) OPTIM 33TB AQUASTAT surface cleaner and disinfectant water distiller From start to dry in the blink of an eye. STATIM ® Autoclaves. Think of how many procedures you could perform in a day. Manufactured by: SciCan GmbH Wangener Strasse 78 88299 Leutkirch GERMANY Tel.: +49 (0)7561 98343 - 0 Fax.: +49 (0)7561 98343 - 699 SciCan, Inc 701 Technology Drive Canonsburg PA, 15317 USA Tel.: 724 820 1600 Fax.: 724 820 1479 Toll free: 1-800 572 1211 STATIM, HYDRIM, and OPTIM are registered trademarks and Your Infection Control Specialist, AQUASTAT, and BRAVO are trademarks of SciCan Ltd. Not all products available in all markets. Contact your local SciCan dealer for product availability. STATIM 5000S SD-224/2-EN 2M 08/11 SciCan Ltd 1440 Don Mills Road O 1 2 3 Toronto, ON M3B 3P9 CANADA Tel.: +1 416 445 1600 Fax.: +1 416 445 2727 STATIM 2000S STATIM 5000 G4 STATIM 2000 G4 26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 3 Sterilise your micro instruments and Phaco handpieces between patients in only 15 minutes and protect them from heat and corrosion. How does STATIM work so fast? The removal of air has long been recognised as critical to achieving sterilisation because air acts as a barrier to the heat (steam) reaching and killing the micro organisms. In fact, unless the steriliser can evacuate air from hollow or wrapped instruments before sterilisation begins, 100% biological kill cannot be achieved. Pressure/Time Comparison Graph 5x faster The STATIM ® 5000S and 5000 G4 cassette autoclaves are the sterilisers of choice for ophthalmologists worldwide because they are the most gentle and feature the fastest sterilising process available today. STATIM will enable you to treat every patient with a complete sterile tray freshly sterilised at the Point of Care inside the theatre. The European Standard recognises that there is more than one way to achieve the removal of air. The extremely gentle action of the STATIM-cycle displaces air from the sterilisation chamber by a patented steam-injection, positive pressure pulse displacement process. This STATIM process is at least five times faster than the typical 45-70 minute cycle of conventional B-cycle vacuum autoclaves. With a complete sterilisation cycle of only 15 minutes, STATIM will optimise operating theatre and clinical time management, improve efficiency and reduce turnover time for all ophthalmology operations and procedures including refractive and cataract surgery. Reduce Costs You could also reduce your investment in Phaco handpieces and micro instruments due to the faster sterilising turnover time. Point of care: A fresh set of sterilised instruments and handpieces for every patient. The gentle action of the STATIM – unique among sterilisers – will cause virtually no corrosion or heat damage to your valuable handpieces and instruments. It’s a new formula! Speed equals money saved and increases the number of daily surgical procedures, without any additional investment in instruments. Sterilisation complete prior to drying Sterilisation complete prior to drying Super-atmospheric 100 kPa Sub-atmospheric 0 Minutes 20 8.5 10 30 40 Minutes STATIM 2000S Autoclave (Hollow/Unwrapped (S) 134˚C/3.5 min) Typical B Cycle Vacuum Autoclave (standard 134˚C/3.5 min Universal B Cycle) (Cycle times are from warm start and load dependent) When the ‘start button’ is pressed, the steam generator heats to the optimum temperature and a defined volume of good quality, distilled water is pumped in and converted to steam. Then, a gentle, non-turbulent wall of steam is automatically injected into the cassette pressure chamber which is loaded with contaminated instruments. Air is purged as the steam courses through the cassette and is continuously expelled into a waste bottle. After any cycle is completed the drying cycle automatically switches on, enhancing and speeding up the drying process. Sterilised instruments can safely be handled within less than one minute after being removed from the cassette. The hourly throughput of instruments of the STATIM is greater than that of conventional benchtop autoclaves because of its rapid cycle speed and five litre capacity. Setting new standards European Standard EN13060 defines and approves three basic cycle classifications of small steam sterilisers. Type of cycle Compare the results: S Solid Unwrapped Hollow Unwrapped Hollow Unwrapped* Hollow Wrapped Hollow Wrapped* Ruber/ Plastic Ruber/ Plastic* 3.5 min./ 134°C 3.5 min./ 134°C 18 min./ 134°C 3.5 min./ 134°C 18 min./ 134°C 15 min./ 121°C 30 min./ 121°C STATIM 2000S / G4 6:45 8:05 22:35 10:40 25:10 18:40 33:40 STATIM 5000S / G4 8:45 10:50 25:20 15:30 30:00 20:20 35:20 Total Cycle time w/o drying Sterilisation time / temp associated equipment is used only for the sterilisation of the type of products for which STATIM cassette autoclaves deliver dramatic improvements in process efficiency through shorter cycle times. Statim “It is essential that the steriliser and Description of approved use by EN13060 The sterilisation of products as specified by the manufacturers of the steriliser including non wrapped solid products and at least one of the following: porous products, small porous items, hollow load products type A, hollow load products B, single wrapped products, multiple-layer wrapped products it is designed. The choice of steriliser, sterilisation cycle or quality of services provided can be inappropriate for a particular load. Therefore the suitability of the sterilisation procedure for a particular N The sterilisation of non wrapped solid products B The sterilisation of all wrapped or non-wrapped, solid, hollow load products type A and porous products as represented by the test loads in this standard product needs to be verified by validation” EN13060. The STATIM cassette autoclave continues to meet all EN13060 requirements. Cycle time is dependent on instrument load. * Choice of programme depends on the instrument manufacturer’s instructions and on the type of use (risk group). 2 3 26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 5 The Certainty of Validation The STATIM difference Validation Attractive, compact, reliable and gentle The STATIM cassette autoclave is validated microbiologically by independent research institutes and tested for specific instruments. These include many major brands of ophthalmic handpieces and instruments and a number of them are listed in the back of this brochure. You can also monitor the STATIM sterilisation cycle on a daily basis with a specifically designed Process Challenge Device (PCD) that makes STATIM an autoclave that can prove its effectiveness by both biological and mechanical means. Monitoring And with routine monitoring using SciCan’s ENSURE line of biological and chemical indicators, you can be certain that STATIM is meeting the challenge of ensuring that you, your staff, and your patients are protected against infection from contaminated instruments. The STATIM is small enough to fit onto a trolley inside the operating theatre. It generates little heat and virtually no noise. The STATIM provides cycles for both wrapped & unwrapped solid and hollow instruments. STATIM ’s steam injector system provides temperature consistency and expels the air that causes oxidation in conventional autoclaves. The STATIM steriliser will only operate if clean, good quality, steam processed, distilled water is used and it uses clean water every cycle, preventing the formation of rust and the build-up of bio contaminants. If the incorrect water is used, the STATIM will not switch on and will display a warning. Independent research*3 shows that there are no detectable endotoxins in the water reservoir of the STATIM. This further helps to reduce any potential problem with Diffuse Lamellar Keratitis (DLK). In addition a 0.3µm biological filter ensures that the air entering STATIM ’s chamber for drying is biologically clean. A compressor switches on immediately after the successful completion of any sterilising cycles, thereby reducing humidity within the chamber with biologically clean dry air. Light, thin-walled STATIM cassettes promote rapid heating and cooling, further minimising overall processing time and reducing instrument exposure to heat. Data Collection An undocumented sterilization cycle might as well not have been done. The integrated printer on the STATIM 5000S can be used as a tracking device as it provides detailed print-out records of all cycle data and parameters. The STATIM 5000S also has a 9-pin RS232 communication port that will allow the unit to be connected to an external Data Logger that can collect cycle information and be added to a USB stick. Ultra-thin walled cassettes allow for rapid heating and cooling The STATIM G4 takes this one step further and features an integrated Data Logger that stores all cycle information for the lifetime of the unit. A USB port allows for the manual retrieval of cycle history. With an Ethernet connection, the STATIM G4 can be put in direct contact with your PC so this information can be viewed, stored and printed whenever necessary. Additionally, the STATIM G4 has an RS232 serial printer port that allows you to connect with an external printer for record creation. 4 Precision inlet/outlet system for quick, thorough steam injection and air purging Schematic of forced air removal design with combined purging A microbiological filter prevents all bacteria and spores larger than 0.3µm from entering the chamber (cassette) during the drying cycle Easy to use Drying STATIM Dri-TecC – Convection Heat Drying Technology The STATIM 5000S is user friendly as a touch keypad and helpful LED display tells the operator exactly what to do. STATIM is also self-diagnosing – if a problem occurs at any stage during the sterilising cycle it will immediately be indicated on the electronic display panel. The STATIM 2000S & 2000 G4 use convection heat to dry instruments by utilizing the remaining heat in the system after the sterilization phase. Heat is captured and released into the cassette, drying wrapped instrument loads in as little as 10 minutes. STATIM G4 Dri-TecR – Radiant Heat Drying Technology Following the same user friendly operation, the STATIM G4 high-resolution, 65K color, 2.5” by 3” touchscreen offers a vivid display of messages, current cycle information and customizable colours all with extraordinary clarity. Fully adjustable contrast levels let you optimize the screen to the lighting in your steri-centre. The STATIM 5000S & 5000 G4 use heat generated by the sterilization cycle which is ‘absorbed’ by unique drying plates located in the sterilization chamber. Heat is transferred from the drying plates directly to instruments resulting in accelerated, full load drying in as little as 15 minutes. 5 26793_SciCan_Opthamology_Layout 1 16/01/12 8:09 AM Page 7 STATIM 2000S / 2000 G4 STATIM Specifications Machine Dimensions: The STATIM 2000S is a compact version of the STATIM 5000S. It is the fastest and most effective sterilisation process available in the world today. The STATIM 2000S autoclave is ideal for use in the doctor’s consulting room because it takes just eight minutes to complete a full cycle. It generates little heat, virtually no noise and is small enough to be placed on a working surface inside the consulting rooms and enables the economy of sterilising instruments between patients. The STATIM 2000S complies with the requirements of the latest standards for the sterilisation of hollow or solid instruments whether or not these are bagged prior to sterilisation. Cassette Size (External): (includes handles) Cassette Size (Internal): Length: Width: Height: Length: Width: Height: Length: Width: Height: Weight (Without water): Electrical Rating: An optional but useful accessory for the STATIM 2000S, the Statprinter helps to make record keeping easier and the cycle print out can be used as a tracking device. Validation and Standards 5000S 2000S 55 cm 48.5 cm 41.5 cm 41.5 cm 19 cm 15 cm 49.5 cm 41 cm 19.5 cm 19.5 cm 8 cm 4 cm 38 cm 28 cm 18 cm 18 cm 7.5 cm 3.5 cm 33 Kg 21 Kg 220 - 240 V, 50Hz, 6A Accessories for STATIM 01-101613S Cassette for STATIM 5000S 01-100008A Cassette for STATIM 2000S 01-101649S Cassette Seal for STATIM 5000S 01-100028S Cassette Seal for STATIM 2000S 01-101657S Thermal Paper (Box of 10 rolls) 01-108341 StatimHelix Test Device 99-108332 Sterilisation Helix Emulator 134˚C 3.5 min (250pcs) Validated ophthalmic instruments 20ZPLUS Stat-dri plus 8oz Alcon NeoSonix Phaco handpiece B&L Gillis irrigating-aspirating cannula E4932 01-108263S Instrument Basket for STATIM 5000S Alcon 279R B&L Gimble irrigating cannula E4894 01-102119S Biological Air Filter Alcon EJG B&L Irrigating-aspirating handpiece MVS 1063C 01-108341 PCD Final Assembly Kit Chiron 6-pin B&L Lasik cannula E4989 01-112385S Standard Cassette Tray with Mesh (5000 G4) MedTec 9-pin B&L Nichamin hydrossection cannula 26g E4421 H 01-101709S Mesh Rack 01-112510S Cassette Tray (5000 Ext G4) 01-112509S Cassette Complete (5000 Ext G4) 01-112384S Cassette Complete (5000 G4) 01-112407S Cassette Tray with Mesh Rack (2000 G4) 01-112406S Cassette Complete (2000 G4) 01-112409S Cassette Lid (2000 G4) The above instruments were tested by third party testing agencies and passed the STATIM 2000S & 5000S’s ‘hollow unwrapped’ cycle. Standard Reference Medical Device Directive Standards (European) EN 13060 Small Steam Sterilisers Standards (Safety, Europe) EN 61010-1 Safety requirements Part 1: General requirements EN 61010-2-040 Safety requirements Part 2-040: for steam autoclaves EN 61326-1 EMC requirements The STATIM complies with the requirements of international standards. References: 1. James L Whitby, Chief of Department Microbiology and Immunology, University Hospital London, Canada. Research on the dental handpiece - the biological indicators were killed at the start of the sterilising part of the cycle. All biological indicators were killed provided they had been subjected to a sterilisation cycle of 90 seconds or greater. 2000 G4 49.5 cm 41.5 cm 15 cm 41 cm 19.5 cm 4 cm 28 cm 18 cm 3.5 cm 22 Kg Order Code Validated Phaco handpieces Cooper Vision 9001 5000 G4 60 cm 41.5 cm 19 cm 49.5 cm 19.5 cm 8 cm 38 cm 18 cm 7.5 cm 34 Kg Optional printer STATIM 5000 / 2000 Type: Print: Print Speed: Paper Roll Capacity: approx. 01-108262S Instrument Basket for STATIM 2000S Thermal Printer 20 characters per line 1 line per second 80 sterilisation cycles per roll 2. Chris H Miller, Professor of Oral Microbiology, Indiana University. Research proving sterility of the Phaco handpiece in half a cycle. Copies available on request 3. James L Whitby, Chief of Department Microbiology and Immunology, University Hospital London, Canada and Victoria Hitchins, The Division of Life Sciences Center of Devices and Radiological Health, USA Food & Drug Administration, Rockville. Research into Endotoxin Levels in Steam and Reservoirs of Table-top Steam Sterilisers. J.Refract Surg 2002; 18: 51-57 6 7
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