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Coltene SciCan STATIM 2000S Operator's Manual

Cassette autoclave
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STATIM
2000S/5000S
®
CASSETTE AUTOCLAVE
• Operators Manual
95-108430 EU EN R13. STATIM 2000/5000 Operator's Manual. Copyright 2020 SciCan Ltd. All rights reserved.

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Summary of Contents for Coltene SciCan STATIM 2000S

  • Page 1 STATIM 2000S/5000S ® CASSETTE AUTOCLAVE • Operators Manual 95-108430 EU EN R13. STATIM 2000/5000 Operator’s Manual. Copyright 2020 SciCan Ltd. All rights reserved.

  • Page 2: Table Of Contents

    Table of Contents 5. Maintenance ..... 20 1. Introduction ..... . . 3 5.1 Cleaning the Cassette 2.

  • Page 3: Introduction

    1. Introduction Statim 5000S Statim 2000S Congratulations on your selection of the STATIM ® Cassette Autoclave. We are confident that you have purchased the finest equipment of its type. The Statim is a compact, counter-top unit that features a number of sterilizing cycles designed to meet your needs and suitability for steam sterilization.

  • Page 4: Important Information

    2. Important Information 2.1 Disclaimers Use only steam-process distilled water in your Statim. Deionized, demineralized, or specially filtered water should not be used. Never use tap water. Do not permit any person other than certified personnel to supply parts for, service or maintain your Statim.

  • Page 5: Statim 2000S - Unit Overview

    2. Important Information Con’t. 2.2 Statim 2000S — Unit overview level indicator Figure 1 keypad reservoir cap/ water filter power indicator active indicator power switch power cable port leveler feet exhaust tube port cassette biological filter compressor RS232 port The following symbols A situation which A potential hazard Important...

  • Page 6: Statim 5000S - Unit Overview

    2. Important Information Con’t. 2.3 Statim 5000S — Unit overview Figure 2 level indicator keypad reservoir cap/ water filter power indicator active indicator power switch power cable port leveler feet exhaust tube port biological filter optional internal printer (not on all models) cassette RS232 port (not on all models)

  • Page 7: Installation

    3. Installation 3.1 Environmental Considerations There are several factors that may affect the performance of your Statim. Please review these factors, and select a suitable location in which to install the unit. • Temperature and Humidity Avoid installing your Statim in direct sunlight or close to a heat source (e.g. vents or radiators).

  • Page 8: Connecting The Waste Bottle

    3. Installation Con’t. 3.3 Connecting the Waste Bottle The waste bottle is used to collect the wastewater after it has been converted to steam and then drained from the cassette. To connect the waste bottle to the Statim, follow these steps (see figure 4): 5000S 1.

  • Page 9: Priming The Statim Pump

    3. Installation Con’t. 1. Remove the reservoir cap 2. Pour steam-process distilled water into the reservoir until almost full (a maximum of 4L). Use a funnel to avoid spillage. 3. Replace and secure the cap. 3.5 Priming the Statim Pump To prime the Statim pump, follow these steps: Figure 5...

  • Page 10: Language Selection

    3. Installation Con’t. 6. To select the next field, press the RUBBER AND PLASTICS cycle button. 7. To save changes and return to the regular operating mode, press the STOP button. 8. To quit without making changes, power the Statim OFF. 3.7 Language Selection The messages displayed on the LCD can be changed to a number of different languages.

  • Page 11: Instructions For Use

    4. Instructions For Use 4.1 Statim 2000S — Using the Cassette When removing the cassette after a cycle, exercise caution as the metal areas will be hot and the cassette may contain hot steam. • To open the cassette: 1. Hold the cassette handle with your thumbs facing inward on the cassette latch. 2.

  • Page 12: Statim 5000S - Cassette

    4. Instructions For Use Con’t. 4.2 Statim 5000S — Using the Cassette When removing the cassette after a cycle, exercise caution as the metal areas will be hot and the cassette may contain hot steam. • To open the cassette: 1.

  • Page 13: Statim 5000S - Stat-Dri Plates

    4. Instructions For Use Con’t. • Removing the cassette: 1. Grasp the cassette handle with one hand and pull out from the unit. 2. As the cassette emerges from the unit, grasp the carry handle with your free hand and lift it upwards.
  • Page 14 4. Instructions For Use Con’t. • Unwrapped Instruments Arrange unwrapped instruments on the rack by spreading them as evenly as possible. • Wrapped Instruments (single wraps) Place the instruments into single layer autoclave bags according to the manufacturer’s instructions. Orient the instrument rack in the cassette to ensure that wrapped instruments rest approximately 6 mm / 0.25”...
  • Page 15 4. Instructions For Use Con’t. • All Instruments The Statim is NOT intended for sterilizing textiles, liquids or biomedical waste. Instruments will remain sterile after a successful cycle until the cassette is disengaged from the unit. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state.

  • Page 16: Selecting A Cycle

    4. Instructions For Use Con’t. 4.6 Selecting a Cycle The Statim 2000S and 5000S have seven sterilization cycles, each designed to sterilize using the parameters specified. Each cycle can be selected by pressing the UNWRAPPED, WRAPPED or RUBBER / PLASTIC cycle buttons. The types of instruments, sterilization requirements and a graph depicting each cycle characteristics are described over the following pages.
  • Page 17 4. Instructions For Use Con’t. 2. Hollow Wrapped Cycles The Statim 2000S and 5000S feature two WRAPPED 134˚C type S sterilization cycles. To select one of these S Cycles: Press the WRAPPED button to scroll through the available cycles. min / 18 min Sterilizing 100˚C / 101 kPa...
  • Page 18 4. Instructions For Use Con’t. Once the desired cycle has been selected, press the START button. The unit remembers the last cycle run and then displays this first when the unit is powered on. 4. Air Dry Only Cycle This is not a sterilization cycle. The load is considered sterile after the successful completion of the sterilization phase of the cycle.

  • Page 19: Running A Cycle

    4. Instructions For Use Con’t. 4.7 Running a Cycle To operate each cycle, follow these steps and watch the LCD . 1. Turn the power switch 14:23 11/15/2006 at the back of the unit to ON. SELECT A CYCLE The LCD display reads: 2.

  • Page 20: Stopping A Cycle

    4. Instructions For Use Con’t. The buzzing noise during the air drying stage is the compressor operating. The air drying phase of the cycle may be interrupted at any time by pressing the STOP button. The display will read: PLEASE WAIT CYCLE COMPLETE When the automatic 60-minute air drying stage is finished the display reads: REMOVE CASSETTE...

  • Page 21: Maintenance

    5. Maintenance 5.1 Cleaning the Cassette Keeping the Statim cassette clean is good clinical practice and assists in the function of the unit. SciCan recommends that the interior surface be cleaned at least once a week. Use dishwashing soap or a mild detergent that does not contain chlorine. Scrub the inside of the cassette with a cleaning pad designed for use with Teflon™...

  • Page 22: Changing The Bacteria Retentive Air Filters

    5. Maintenance 5.6 Changing the Bacteria Retentive Air Filters The filters should be replaced every six months or after 500 cycles to maintain an adequate supply of clean air during the air drying cycle. To change the bacteria retentive air filter on the Statim 2000S and 5000S, follow these steps: 1.

  • Page 23: Maintaining Fluid Levels

    5. Maintenance con’t. Remove the old seal and discard. Clean any residue out of the seal channel and flush out the channel with distilled water. Lubricate the new seal with the liquid seal lubricant provided. Insert the rounded edge of the seal under the round lip of the lid.

  • Page 24: Preventative Maintenance Schedule

    5. Maintenance con’t. 5.10 Preventative Maintenance Schedule To ensure trouble-free performance, both the operator and the dealer must follow a preventative maintenance schedule. NOTE: Please refer to your National, Regional, State or Safety laws for any additional reoccurring user testing that may be required. The schedules below describe the necessary actions.

  • Page 25: The Communication Port

    6. The Communication Port 6.1 The RS232 Communication Port All Statim units that do not have an internal Printer printer will have an RS232 communication port that will allow you to connect to an external printer or to a SciCan Data Logger. For printing, you will need to purchase a recommended printer (see list below) from your local computer or electronics store.
  • Page 26 6. The Communication Port con’t. 6.2 Installing the SciCan Data Logger SciCan’s USB Data Logger can record and store cycle information onto a mass storage device (MSD) such as a USB Flash Drive or SD memory card. These instructions are for units with a 9-pin communication (RS232) port located at the back of the unit.
  • Page 27 6. The Communication Port con’t. Setting the Serial Port Bitrate to 9600 9600 Serial Port Bitrate 1. From the User Setup menu, use the UNWRAPPED and WRAPPED buttons to scroll to the Serial Port Bitrate menu and select it using the RUBBER AND PLASTIC button. 2.
  • Page 28 6. The Communication Port con’t. Step 2 Selecting the Time and Date HH:MM DD/MM/YYYY Time/Date Note: If the time and date were set according to section 3.6, this does not have to be performed again. 1. Power up unit while pressing the STOP button to access the User Setup menu. 2.

  • Page 29: Installing Paper On The Internal Printer

    6. The Communication Port con’t. 6.3 Installing Paper on the Internal Printer Use only paper approved for use with the optional internal printer on the Statim 5000S. The use of any other paper will damage the printer and will void the warranty. Thermal paper is available from SciCan (SciCan order no.
  • Page 30 6. The Communication Port con’t. 7. Continue to press the paper advance button until the paper feeds through the paper exit slot on the front of the printer. Then, move the paper roll and arm into the operating position and close the printer door .

  • Page 31: Removing Internal Printer Paper Jams

    6. The Communication Port con’t. 6.4 Removing Internal Printer Paper Jams If paper jams in the printer and cannot be removed by pressing the paper advance button , the printer must be disassembled. Do not pull the paper backwards through the printer and never put utensils or tools into the paper exit slot.
  • Page 32 6. The Communication Port con’t. 2. Place the printed wiring board back into position on the printer door. Note the alignment of the mounting holes in the wiring board and the mounting bosses on the printer door. The black plastic printer body rests between the locating ribs on the inside of the printer door.
  • Page 33 6. The Communication Port con’t. 6.5 Cycle Printout Overview Model: STATIM 2000 software: S2S2R410 Unit Identifier: autoclave has been set up as number 323 Cycle counter: the number of cycles having been run on the unit = 9 Time / Date: 1:38 pm 14th April, 2003 Cycle Name: SOLID 10 .
  • Page 34 6. The Communication Port con’t. 11. Start Time of Pressurization: 3:21(start of ‘C’ phase) 12. Start Time of Sterilization: 4:12 (start of ‘D’ phase) 13. Temp. / Press. & Time at start of sterilization (‘D’ phase) 14. Min. Temp. / Press during the sterilization phase (lower limits of ‘D’ phase) 15.

  • Page 35: Troubleshooting

    7. Troubleshooting Problem Solution Check that the unit is plugged into a properly Unit does not power ON. grounded outlet and that the power cord is firmly seated at the rear of the machine. Try another circuit. Power unit OFF for 10 seconds and then power ON again.
  • Page 36 7. Troubleshooting con’t. If kinked, straighten the tube. If the tube cannot be straightened, remove it from the push-in fitting attached to the Statim. Depress the collar on the fitting and with the other hand pull firmly on the tube. Once the tube is free of the fitting, cut the damaged section of tubing away using a sharp instrument.
  • Page 37 7. Troubleshooting con’t. Excessive steam issuing from the front Remove and reinsert the cassette. Attempt another of the machine. cycle. Remove and check the cassette seal for misalignment or damage. Replace the seal if required. Be careful as the metal parts will be hot and the cassette will contain hot steam.
  • Page 38 7. Troubleshooting con’t. Message MSD NOT CONNECTED <> Check the serial cable connection. INSERT MSD/FLASH Check the power connection. Ensure the lower red LED is lit. Check that the Mass Storage Device is properly inserted. Repeat the instructions for Installing the SciCan Data Logger on your Statim.

  • Page 39: Spare Parts List

    8. Spare Parts List 01-100204S Exhaust Tube 01-100207S Compressor Filter (2000S) 01-100724S Condenser Bottle w / o 01-104786S Instrument Holder - 4 mm Condenser (5000S) 01-100735S Waste Water Bottle Fitting 01-100028S Cassette Seal (2000S) 01-100780S Bumper 01-106438S Cassette Lid, Extended (2000S) 01-100812S Condenser Bottle 01-108340S Statim PCD –...

  • Page 40: Warranty

    9. Warranty Limited Warranty For a period of one year, SciCan guarantees that the Statim 2000S / 5000S, when manufactured by SciCan in new and unused condition, will not fail during normal service due to defects in material and workmanship that are not due to apparent abuse, misuse, or accident.

  • Page 41: Test Protocol

    10. Test Protocol 10.1 Type test...
  • Page 42 10. Test Protocol con’t. STATIM 2000S STATIM 5000S Cycle Cold Unit With Max. Load + Cold Unit With Max. Load + Drying Phase Drying Phase Warm Unit Without Load + Warm Unit Without Load + Drying Phase Drying Phase SOLID UNWRAPPED (N) 9:15 + 60:00 13:15 + 60:00 134˚C / 3.5 min...

  • Page 43: Specifications

    11. Specifications 11.1 Statim 2000S — Specifications Length: 48.5 cm Machine Dimensions: Width: 41.5 cm Height: 15 cm Cassette Size (External): Length: 41 cm (includes handles) Width: 19.5 cm Height: 4 cm Cassette Size (Internal): Length: 28 cm Width: 18 cm Height: 4 cm 1.8 L...

  • Page 44: Statim 5000S - Specifications

    11. Specifications con’t. 11.2 Statim 5000S — Specifications Machine Dimensions: Length: 55 cm Width: 41 cm Height: 19 cm Cassette Size (External): Length: 49.5 cm (includes handles) Width: 19.5 cm Height: 8 cm Cassette Size (Internal): Length: 38 cm Width: 18 cm Height: 8 cm...

  • Page 45: Declaration Of Conformity

    12. DECLARATION OF CONFORMITY Classification: Class IIa (MDD Annex IX, Rule 15) SciCan Ltd. Manufacturer: Manufacturer Address: 1440 Don Mills Road Telephone (416) 445-1600 Toronto, Ontario (416) 445-2727 M3B 3P9 Canada European Representative: SciCan GmbH Wangener Straße 78 88299 Leutkirch Germany We herewith declare that the above mentioned products meet the provisions of the following EC Council Directive and Standards and that SciCan Ltd.

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