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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.

SciCan GmbHWangener Strasse 7888299 LeutkirchGERMANYTel.: +49 (0)7561 98343 - 0Fax.: +49 (0)7561 98343 - 699

SciCan, Inc701 Technology DriveCanonsburg PA, 15317USATel.: 724 820 1600Fax.: 724 820 1479Toll free: 1-800 572 1211

SciCan Ltd1440 Don Mills RoadToronto, ON M3B 3P9CANADATel.: +1 416 445 1600Fax.: +1 416 445 2727

Manufactured by:

SD-224/2-EN 2M 08/11

BRAVOfractionated vacuum steriliser

HYDRIM M2HYDRIM L110washer/disinfector

AQUASTATwater distiller

OPTIM 33TBsurface cleaner and disinfectant

Bravo17 (220-240V, 10A 50 Hz, Printer) Bravo17V (220-240V, 10A, 50Hz, Printer)Bravo21V (220-240V, 10A, 50Hz, Printer)

From start to dry in the blink of an eye.STATIM® Autoclaves.Think of how many procedures you could perform in a day.

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EN13060

Fully Complia

nt

STATIM 2000 G4STATIM 5000 G4STATIM 5000S STATIM 2000S

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The STATIM ® 5000S and 5000 G4 cassette autoclaves are thesterilisers of choice for ophthalmologists worldwide because theyare the most gentle and feature the fastest sterilising processavailable today. STATIM will enable you to treat every patient with acomplete sterile tray freshly sterilised at the Point of Care insidethe theatre.

With a complete sterilisation cycle of only 15 minutes, STATIM willoptimise operating theatre and clinical time management, improveefficiency and reduce turnover time for all ophthalmology operationsand procedures including refractive and cataract surgery.

Reduce CostsYou could also reduce your investment in Phaco handpieces andmicro instruments due to the faster sterilising turnover time.

The gentle action of the STATIM – unique among sterilisers – willcause virtually no corrosion or heat damage to your valuablehandpieces and instruments. It’s a new formula! Speed equalsmoney saved and increases the number of daily surgicalprocedures, without any additional investment in instruments.

The hourly throughput of instruments of the STATIM is greater thanthat of conventional benchtop autoclaves because of its rapidcycle speed and five litre capacity.

Setting new standardsEuropean Standard EN13060 defines and approves threebasic cycle classifications of small steam sterilisers.

“It is essential that the steriliser and

associated equipment is used only for the

sterilisation of the type of products for which

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

product needs to be verified by validation”

EN13060.

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The STATIM cassette autoclave continues to meetall EN13060 requirements.

Description of approved use by EN13060

The sterilisation of products as specified by the manufacturersof 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

The sterilisation of non wrapped solid products

The sterilisation of all wrapped or non-wrapped, solid, hollowload products type A and porous products as representedby the test loads in this standard

N

S

B

Sterilise your micro instruments and Phaco handpiecesbetween patients in only 15 minutes and protect themfrom heat and corrosion.

Point of care: A fresh set of sterilised instruments and handpieces for every patient.

Type ofcycle

When the ‘start button’ is pressed, the steam generator heats to the optimum temperature and a defined volume of goodquality, distilled water is pumped in and converted to steam. Then, a gentle, non-turbulent wall of steam is automaticallyinjected into the cassette pressure chamber which is loaded with contaminated instruments. Air is purged as the steamcourses through the cassette and is continuously expelled into a waste bottle. After any cycle is completed the drying cycleautomatically switches on, enhancing and speeding up the drying process. Sterilised instruments can safely be handled withinless than one minute after being removed from the cassette.

The removal of air has long beenrecognised as critical toachieving sterilisation because airacts as a barrier to the heat(steam) reaching and killing themicro organisms. In fact, unless

the steriliser can evacuate air from hollow orwrapped instruments before sterilisation begins,100% biological kill cannot be achieved.

The European Standard recognises that there ismore than one way to achieve the removal of air.The extremely gentle action of the STATIM-cycledisplaces air from the sterilisation chamber by apatented steam-injection, positive pressure pulsedisplacement process. This STATIM process is atleast five times faster than the typical 45-70minute cycle of conventional B-cycle vacuumautoclaves.

5xfaster

100 kPa

10 8.5 0 Minutes

Sterilisation complete prior to drying

Sterilisation complete prior to drying

Super-atmospheric

Sub-atmospheric

Pressure/Time Comparison Graph

20 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)

How does STATIM work so fast?

Compare the results:STATIM cassette autoclaves deliver dramatic improvements in processefficiency through shorter cycle times.

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

Statim Solid Hollow Hollow Hollow Hollow Ruber/ Ruber/ Total Cycle time w/o drying Unwrapped Unwrapped Unwrapped* Wrapped Wrapped* Plastic Plastic*

Sterilisation time / temp 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

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).

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The STATIM differenceAttractive, compact, reliable and gentle

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Easy to useSTATIMThe STATIM 5000S is user friendly as a touch keypad and helpful LED display tellsthe operator exactly what to do. STATIM is also self-diagnosing – if a problemoccurs at any stage during the sterilising cycle it will immediately be indicated onthe electronic display panel.

STATIM G4Following the same user friendly operation, the STATIM G4 high-resolution, 65Kcolor, 2.5” by 3” touchscreen offers a vivid display of messages, current cycleinformation and customizable colours all with extraordinary clarity. Fully adjustablecontrast levels let you optimize the screen to the lighting in your steri-centre.

DryingDri-TecC – Convection Heat Drying TechnologyThe STATIM 2000S & 2000 G4 use convection heat to dry instruments byutilizing the remaining heat in the system after the sterilization phase. Heat iscaptured and released into the cassette, drying wrapped instrument loads inas little as 10 minutes.

Dri-TecR – Radiant Heat Drying TechnologyThe STATIM 5000S & 5000 G4 use heat generated by the sterilization cyclewhich is ‘absorbed’ by unique drying plates located in the sterilizationchamber. Heat is transferred from the drying plates directly to instrumentsresulting in accelerated, full load drying in as little as 15 minutes.

Ultra-thin walled cassettes allow forrapid heating and cooling

Precision inlet/outlet system for quick,thorough steam injection and air purging

Schematic of forced air removal designwith combined purging

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 conventionalautoclaves. The STATIM steriliser will only operate if clean, good quality, steam processed, distilled water is used and it usesclean water every cycle, preventing the formation of rust and the build-up of bio contaminants. If the incorrect water is used, theSTATIM will not switch on and will display a warning. Independent research*3 shows that there are no detectable endotoxins inthe 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 humiditywithin 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.

A microbiological filter prevents allbacteria and spores larger than 0.3µmfrom entering the chamber (cassette)during the drying cycle

The Certainty of ValidationValidation The STATIM cassette autoclave is validated microbiologically by independentresearch institutes and tested for specific instruments. These include many majorbrands of ophthalmic handpieces and instruments and a number of them arelisted in the back of this brochure.

You can also monitor the STATIM sterilisation cycle on a daily basis with aspecifically designed Process Challenge Device (PCD) that makes STATIM anautoclave that can prove its effectiveness by both biological and mechanicalmeans.

Monitoring And with routine monitoring using SciCan’s ENSURE line of biological andchemical indicators, you can be certain that STATIM is meeting the challenge ofensuring that you, your staff, and your patients are protected against infection fromcontaminated instruments.

Data CollectionAn undocumented sterilization cycle might as well not have been done. Theintegrated printer on the STATIM 5000S can be used as a tracking device as itprovides detailed print-out records of all cycle data and parameters. The STATIM5000S also has a 9-pin RS232 communication port that will allow the unit to beconnected to an external Data Logger that can collect cycle information and beadded to a USB stick.

The STATIM G4 takes this one step further and features an integrated Data Loggerthat stores all cycle information for the lifetime of the unit. A USB port allows forthe manual retrieval of cycle history. With an Ethernet connection, the STATIM G4can be put in direct contact with your PC so this information can be viewed,stored and printed whenever necessary. Additionally, the STATIM G4 has anRS232 serial printer port that allows you to connect with an external printer forrecord creation.

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STATIM 2000S / 2000 G4 STATIM Specifications 5000S 2000S 5000 G4 2000 G4Machine Dimensions: Length: 55 cm 48.5 cm 60 cm 49.5 cm

Width: 41.5 cm 41.5 cm 41.5 cm 41.5 cmHeight: 19 cm 15 cm 19 cm 15 cm

Cassette Size (External): Length: 49.5 cm 41 cm 49.5 cm 41 cmWidth: 19.5 cm 19.5 cm 19.5 cm 19.5 cmHeight: 8 cm 4 cm 8 cm 4 cm

Cassette Size (Internal): Length: 38 cm 28 cm 38 cm 28 cmWidth: 18 cm 18 cm 18 cm 18 cmHeight: 7.5 cm 3.5 cm 7.5 cm 3.5 cm

Weight (Without water): 33 Kg 21 Kg 34 Kg 22 KgElectrical Rating: 220 - 240 V, 50Hz, 6A

The STATIM 2000S is a compact version of the STATIM 5000S.It is the fastest and most effective sterilisation process availablein the world today. The STATIM 2000S autoclave is ideal for usein the doctor’s consulting room because it takes just eightminutes to complete a full cycle. It generates little heat, virtuallyno noise and is small enough to be placed on a working surfaceinside the consulting rooms and enables the economy ofsterilising instruments between patients. The STATIM 2000Scomplies with the requirements of the latest standards for thesterilisation of hollow or solid instruments whether or not theseare bagged prior to sterilisation.

(includes handles)

The STATIM complies with the requirements of international standards.

Standard Reference Medical Device DirectiveStandards (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 above instruments were tested by third party testing agencies and passed the STATIM 2000S & 5000S’s ‘hollowunwrapped’ cycle.

Validated ophthalmic instruments

B&L Gillis irrigating-aspirating cannula E4932

B&L Gimble irrigating cannula E4894

B&L Irrigating-aspirating handpiece MVS 1063C

B&L Lasik cannula E4989

B&L Nichamin hydrossection cannula 26g E4421 H

Validated Phaco handpiecesAlcon NeoSonix Phaco handpiece

Alcon 279R

Alcon EJG

Chiron 6-pin

MedTec 9-pin

Cooper Vision 9001

An optional but useful accessory for the STATIM 2000S,the Statprinter helps to make record keeping easier andthe cycle print out can be used as a tracking device.

References:1. James L Whitby, Chief of Department Microbiology and Immunology, University Hospital London, Canada. Research on the dental handpiece - the biologicalindicators 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.

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 SciencesCenter of Devices and Radiological Health, USA Food & Drug Administration, Rockville. Research into Endotoxin Levels in Steam and Reservoirs of Table-topSteam Sterilisers. J.Refract Surg 2002; 18: 51-57

Validation and Standards

Order Code Accessories for STATIM01-101613S 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)

20ZPLUS Stat-dri plus 8oz

01-108263S Instrument Basket for STATIM 5000S 01-108262S Instrument Basket for STATIM 2000S

01-102119S Biological Air Filter

01-108341 PCD Final Assembly Kit

01-112385S Standard Cassette Tray with Mesh (5000 G4)

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)

Optional printer STATIM 5000 / 2000Type: Thermal PrinterPrint: 20 characters per linePrint Speed: 1 line per secondPaper Roll Capacity: approx. 80 sterilisation cycles per roll

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