SOLUSCOPE SERIES 3 DESIGNED WITH THE FUTURE IN MIND FEATURES FLEXIBLE ENDOSCOPE DISINFECTOR / STERILISER

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1 SOLUSCOPE SERIES 3 FLEXIBLE ENDOSCOPE DISINFECTOR / STERILISER FEATURES Sterile Cycle HLD Cycle Continuous Leak Test Channel Flow Monitoring Pre Disinfection Wash Cycle Fast Cycle Time Barcode Tracking Compliant with: AS/NZ EN TGA Approved System DESIGNED WITH THE FUTURE IN MIND

2 The Soluscope 3 is an Automatic Endoscope Reprocessor with many advanced features not available on competitor machines. The Soluscope is the answer for endoscope cleaning in Hospitals, Day Surgeries and Endoscopy Clinics. It has unparalleled safety for the Patient, Operator and Endoscope. It s also fast. Within 19 minutes the Soluscope 3 completes cleaning and disinfection of the endoscope. Multi Step Reprocessing: The Soluscope 3 reprocessor uses a multi step process, meeting the latest European regulations: 1) Pre-cleaning: The Soluscope forces high pressure water and air through each individual channel to remove any debris. 2) Cleaning: The first cleaning stage injects cleaning solution through each channel of the endoscope, effectively removing biofilm prior to the disinfection/ sterilisation stage. 3) Disinfection/ Sterilisation: A simple push button choice for HLD (High Level Disinfection) or Sterile cycle to effectively process the endoscope. 4) Rinse: High volume, High flow-rate rinse to remove residual chemistry, making it safe for the patient. 5) Drying: Internal endoscope channels are dried with Sterile Air. 6) Alcohol Drying: Alcohol assist drying for the end of day cycle. Channel Flow Control: Step 1: Air pressure injection of chemical through endoscope channel. Step 2: Microprocessor confirmation of correct flow parameters for the individual endoscope in the Soluscope. Step 3: Repeat each individual channel in series: biopsy, air, water, additional & aspiration. Step 4: Repeat sequence (Steps 1-3) at start, end and 3 times during the cycle. Step 5: Channel parameters printed onto validated printout. The Soluscope 3, double checks all parameters to guarantee the endoscope is cleaned and disinfected / sterilised every time. Soluscope 3 is the first to provide individual channel flow control monitoring of the Endoscope during reprocessing. Six times throughout each cycle the Soluscope measures and evaluates the flow profile down each individual endoscope channel. If the channel is not connected correctly or a channel is wholly or partially blocked the Soluscope 3 will detect the problem and alert the operator. This helps speed up the manual cleaning requirement of the endoscope prior to placement in the Soluscope. Soluscope 3 simplifies the cleaning process.

3 Proof of Process / Traceability: Barcode Tracking: Reading the barcode of the endoscope, machine and operator, along with the end of cycle print out provides the operator with a clear conscious, knowing that all the details of the endoscope reprocessing are recorded, providing proof of reprocessing. Barcode reader: Speeds up and improves data input, allows: Patient details Operator details Cycle type Endoscope number. Fast and user friendly. The new cycle confirmation printout now includes: Hospital Name Soluscope Serial Number Cycle Details Cycle Count Date / Time Soluscope 3 s validated printout allows the following information and parameters (shown here on the left) to be displayed. Soluscope knows your scope, its model, brand, serial number, flow profile, providing guaranteed correct reprocessing everytime. Correct cycle every time, proof on the printout. Operator details Patient details Endoscope number and details Leak test details Temperature for each phase Confirmation of chemical dose Channel Flow Times System Fill Times Cycle time & completion

4 Connection Sets Easy Connection of Endoscopes: All brands of flexible endoscopes can be processed in the Soluscope 3, including Olympus, Pentax and Fujinon. Based on Gallay s knowledge and experience, Connection Sets are provided that ensure quick and easy connecting and disconnecting of the endoscope. SOLUSCOPE 3CC PAA CYCLE DESCRIPTION: Cycle 1 Between Patients Cycle 2 End of Day (Alcohol Dry) Cycle 3 Sterile Concentration for 3CC-PAA model Cycle 4 Start of Day Cycle 5 Alcohol Dry Only Cycle 6 End of Day Self Disinfection Leak Test Leak Test Leak Test Leak Test Drying Disinfection Dynamic high flow wash Cleaning, with Dynamic high flow wash Cleaning, with Dynamic high flow wash Cleaning, with Rinsing Rinsing Rinsing Rinsing with Channel Control Disinfection with Rinsing with Channel Control Disinfection with Rinsing with Channel Control Sterilisation with Rinsing with Channel Control Drying Drying Drying Alcohol Injection Drying Disinfection with Alcohol Injection Machine Disinfection Drying Drying 0.2µm water filter disinfection Deferred rinsing, launched by the user Internal circuits drying TIME : 19* min. TIME : 22* min. TIME : 24* min. TIME : 15* min. TIME : 3 min. TIME : 30 min. *Cycle Time depends on Water Temperature, Water Pressure and the configuration of your endoscope Specific Self Disinfection Cycle: At the end of the day a machine self disinfection cycle is set (Cycle 6). This unique self disinfection cycle, chemically disinfects the 0.2μm water filter, the bowl and internal lines. This ensures that endoscopes are not contaminated.

5 Soluscope was first to introduce features that others now copy, including: Continuous Leak Test: Bar Code Input: The leak test is active and continuously monitored during the entire disinfection program. This unique feature ensures perfect endoscope function. It reduces patient risk from cross contamination and reduces repairs of endoscopes, as leaks are detected before major repairs are required. Upon installation of the Soluscope, each Endoscope is validated. Serial numbers, make and model of the endoscope are programmed into the Soluscopes computer. Once the operator selects the required reprocessing cycle and scans the Endoscope BarCode the cycle is then fully computer controlled. Operator Safety: Pneumatic lid seal ensures no fumes reach the operator or the external environment. With infection control in mind, the large pneumatic lid release button allows the lid to be automatically opened without need for the operator to manually touch or lift the lid. With these two features, and the control of the Soluscope to only open after the endoscope has been rinsed, results in absolute safety for the operator. Alarms: The intelligent Soluscope 3 has a range of Alarms, warning the operator before potential problems arise. Alarms include: scope is not connected, chemical solutions are running low, water filter needs to be changed or lid is not closed.

6 Choice of Models: Soluscope 3 gives you the choice of; 1) Standard or Big Bowl Option. The Big Bowl Soluscope is the only machine able to process EUS Scopes. 2) Two Biocides (chemistries) Peracetic Acid (3CC-PAA machine) or Glutaraldehyde (3CC-GTA machine). The Peracetic Acid machine is approved to run both High Level Disinfection and Sterile Cycles. The two different chemistries allows you a choice, depending on OH&S policies, endoscope requirements and user preferences. Flexible endoscopes come in all shapes, sizes and functionality Soluscope 3 accommodates most endoscopes. The following shows the various models and their capabilities. Model Chemistry Bowl Structure Efficacy Level Series 3 PAA Peracetic acid Standard Sterile or HLD Series 3 PAA-BB Peracetic acid Large capacity for EUS scopes Sterile or HLD Series 3 GTA Gluteraldehyde Standard HLD Series 3 GTA-BB Gluteraldehyde Large capacity for EUS scopes HLD Gastroscopes, colonoscopes All brands with / without additional channels Ultrasound Scopes Available in large bowl version Endoscope Compatibility Bronchoscopes Duodenoscopes Cystoscopes All brands All brands, high pressure flush ensures elevator channel flush Cycle 3, sterile concentration of the PAA model machine Sterile Cycle (3CC-PAA model): The Soluscope 3 is the first endoscope reprocessor (AFER) which can achieve sterile concentration via controlled dosing from the sterilant storage container. This ensures that the Soluscope 3 controls and monitors the exact dose requirement to achieve the level of process required. Via the new European Norms (EN15883) the Soluscope 3 must have dual control for all critical steps in its cycle. Single Use Chemistry: The Soluscope 3 makes life easy for the operator, single use chemistry ensures correct concentration every time of the disinfectant. No manual testing, just a validated program TGA approved guaranteeing efficacy everytime. Chemical Solution Monitoring: All solutions are volume or cycle monitored. Operators are pre-warned of impending low solution levels and of "run out" status.

7 Soluscope Accessories: Complete System: Trolley* Printer Water Filtration System Booster Pump *NOTE: The Soluscope can sit on either a bench or trolley. Soluscope Drying stage Sterile Air Drying: At the end of each cycle the internal channels and the outside of the endoscope are dried with sterile air, making the endoscope ready for the next patient. Alcohol drying is used in the End of Day Cycle for overnight storage. Biological and Chemical Monitoring for Sterile Cycle: (only for 3CC-PAA) Conforming with Australian Standards Chemical Monitor - Each sterile cycle (Cycle 3) Biological Monitor - Weekly Microbiological Testing: Due to the history of endoscopes becoming contaminated by bacteria from re-use of disinfectant both from manual cleaning and disinfection and through Automatic endoscope processors that re-use the disinfectant, GENSA guidelines Infection control in Endoscopy quote that all automatic processors should be microbiologically tested once a month. The Soluscope does not re-use the cleaner or disinfectant/sterilant, therefore it is very unlikely that the machine will be colonized. However, in order to satisfy the GENSA policy, we recommend a sampling method to test the Soluscope. The Microbiological Test Kit is: Sterile Packed Easy to Use Correct Sample Volume Time saving

8 Technical Specifications Dimensions: External (open): 1100 x 800 x 670 mm (HxDxW) External (closed): 500 x 800 x 670 mm (HxDxW) Note: Height dimensions do not include bench. (Recommended bench height 700mm). PERFORMANCE Wash Cycle Efficacy Time Chemistry Temp C Drying Includes dynamic Contact time 5 Either PAA 45 C Disinfection, wash cycle with minutes, full cycle in (Peracetic Acid) 50 C Sterile air purge down all 20 minutes* or GTA concentration (in channels. (Glutaraldehyde) 3CC-PAA model) HLD compliance on Cycles 1, 2 & 4. Cycle 3 sterile concentration for 3CC-PAA models (Cycle 3 HLD cycle on 3CC-GTA models) SUPPLY microprocessor controlled. End of cycle drying phase with bacteria free air. Cycle 2 includes alcohol assisted drying. Cold/Hot Water Drain Electricity Air Exhaust Rinse Water Water Quality Max 400kpa, 4 L/min flow rate minimum, ¾ BSP 50mm for 1 drain line at 900mm height 240V AC, 15 amp Not required - sealed unit 0.2um Pharmaceutical grade bacteria filter. (AS4187) Hardness: Max 150ppm ph: VALIDATION Cleaning Temperature Printer & Barcode Efficacy Leak Test Channel Monitoring Pump pressure monitoring, flow control on dose pumps Pt 100 probes. Independent Control & Monitor process * Dependent on water temperature & quality Printout validates cycle process, barcode validates your scopes Sporocidal, virucidal, Tuberculocidal, fungicidal, bactericidal chemistry Continuous leak test throughout cycle ensures full disinfection Your Local Distributor is: Each channel monitored for correct flow up to 6 times per cycle. (as per EN ) HEAD OFFICE MELBOURNE BRISBANE OFFICE SYDNEY OFFICE 6 Florence Street, Burwood, VIC 3125 Unit 3, Hook Street, Capalaba, QLD, 4157 Unit 3/4 Duck Street, Auburn, NSW 2144 Phone: (03) Facsimile: (03) Phone: (07) Facsimile: (07) Phone: (02) Facsimile: (02) Web: or www. soluscope.com.au

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