SciCan STATCLAVE G4 Operator's Manual
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SciCan STATCLAVE G4 Operator's Manual

Chamber autoclave
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STATCLAVE
G4 -
™
Chamber Autoclave
Operator's Manual
95-115362 CA EN R3

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Summary of Contents for SciCan STATCLAVE G4

  • Page 1 STATCLAVE G4 - ™ Chamber Autoclave Operator’s Manual 95-115362 CA EN R3...
  • Page 2 For all service and repair inquiries: Canada: 1-800-870-7777 techservice.ca@scican.com Manufactured by: SciCan Ltd. 1440 Don Mills Road, Toronto, ON M3B 3P9 Canada Telephone: (416) 445-1600 Fax: (416) 445-2727 Toll free: 1-800-667-7733 STATCLAVE G4 Operator’s Manual, Copyright 2019 SciCan Ltd. All rights reserved.
  • Page 3 Quick Start Guide 1. Switch the autoclave ON. 2. Ensure BOTH reservoirs are filled with high quality distilled water. IMPORTANT! Never Use Tap Water. More information IN SECTION 4. 3. Ensure BOTH drainage tubes are connected at the back. 4. Pull up on the door latch to open the door. More information in SECTION 2.3 More information in SECTION 1.7 6.

  • Page 4: Table Of Contents

    1. Your STATCLAVE 9. Storing, Retrieving and Printing Sterilization Records Checking the Package Contents Important Information About Using Your STATCLAVE 4 Retrieving Cycle Information Using the Touchscreen Retrieving Cycle Information Using the Web Portal Operating Principles, Key Features and Safety Devices Retrieving Cycle Information Using the USB Data Back Up...

  • Page 5: Your Statclave

    Your STATCLAVE Checking the Package Contents When you receive your STATCLAVE, the items listed below will be included. If any of the items are missing, contact your dealer immediately. Included with your STATCLAVE 4 Stainless steel wire 1 Waste bottle instrument trays 1 Chamber rack 1 USB Memory stick...

  • Page 6: Important Information About Using Your Statclave

    Important Information About Using Your STATCLAVE Intended Use The STATCLAVE G4 is a dynamic air removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, pharmaceutical products, bio-medical waste or materials not compatible with steam sterilization.

  • Page 7: Operating Principles, Key Features And Safety Devices

    Pay close attention to the following symbols that appear on the unit: Caution: A potential hazard to the operator Venturi reservoir drain Caution: Hot surface Clean water drain Caution: Danger of electric shock. Condenser drain (only used for shipping and Disconnect power supply when servicing unit.
  • Page 8 Other Features Closed-door drying Ensures your wrapped and pouched loads finish dry and ready to store. Deep chamber Holds up to 4 large and 4 small IMS cassettes or up to 20 pouched loads. Reservoir fill options Includes front and top options, as well as an autofill port at the back. Chamber preheating Programmable chamber preheating and unit Stand-by mode ensure the STATCLAVE is warm and ready when you need it.

  • Page 9: Unit Overview

    Unit Overview Venturi reservoir drain quick-connect (OUT) 10. Power cord input Warm air exhaust 11. Ethernet port (not visible) Clean water reservoir drain quick-connect (OUT) 12. Auto fill port for clean water reservoir Clean water reservoir fill quick-connect (IN) 13. Condenser drain port (to drain for shipping) Power switch 14.

  • Page 10: Touchscreen Overview

    Touchscreen Overview Home Screen Solid / Hollow / Solid / Wrapped Unwrapped Unwrapped System icons: Connectivity: Access network and Internet. USB: View cycle history. Door Lock: Unlock door. Settings: Access settings menu. Test Cycles Hollow / Wrapped Rubber & Plastic Complete cycle information in Section 7 Textiles/Porous More information on icons and software screens in Appendices A and B.

  • Page 11: Unlocking The Door

    Unlocking the Door The STATCLAVE will lock the chamber door when you select a cycle. To unlock the door, go to the home screen and follow these steps: PRESS lock icon. PRESS unlock icon. PRESS the back icon. Lock icon is now changed to unlocked.

  • Page 12: Set Up

    Set Up Installing Your STATCLAVE › Place the STATCLAVE on a flat level surface strong enough 17.5” to support a 175 lbs (79.5 kg) load. › Allow for at least 7” (180 mm) of space ABOVE the unit 7” to enable access to the reservoirs. If there is less than 7”...

  • Page 13: Connecting And Powering Your Statclave

    Connecting and Powering Your STATCLAVE Ensure the power switch at the front right of the unit is in the OFF position and connect the power cord supplied to the power port at the back of the unit. Connect directly to a power source. Don’t use an extension cord.
  • Page 14 Connecting Directly to a Drain Any new central drain point installation should be done by a technician. The drain points (C) must be located on the upper portion of vertical drain pipe ABOVE the P-trap. For direct-to-drain connections, you will need to use the direct-to-drain hardware (provided with the unit). The unit is shipped with plugs in its ports.

  • Page 15: Connecting Your Statclave To A Network

    Connecting the Waste Bottle The unit is shipped with a waste bottle in case a direct-to-drain installation is not possible. To use the waste bottle, follow these steps: Set the waste bottle (D) on the ground or in the cabinetry below the unit. Connect the exhaust tube (A) to a port on the waste bottle cap (C).
  • Page 16 Connecting to a Wireless Network From the unit’s home screen, select the SETTINGS icon, then follow these steps: Data Security and WiFi Ensuring your WiFi® connections are secure is an important element of safeguarding your organization’s data. A WiFi network using WPA2™ provides both security (you can control who connects to it) and privacy (the transmissions cannot be read by others) for communications as they travel across your network.

  • Page 17: Getting Started

    From the home screen, select the SETTINGS icon then the USER icon and then the GENERAL button to access the menu for time, date, country, and time zone. (See Section 8 Using and Changing Settings) (SciCan recommends connecting and registering your STATCLAVE. To do this at a later time, see Section 8.5 Registering for STATCLAVE Online Access.)

  • Page 18: 4. Filling The Water Reservoirs

    Open the clean water reservoir located on the top right of the unit. Using a large container, fill with distilled water to the maximum fill level line or until you hear 3 BEEPs. (For more fill options see Section 4. Filling the Water Reservoirs.) Open and fill the Venturi reservoir to the maximum fill level.

  • Page 19: Filling The Water Reservoirs

    Filling the Water Reservoirs Normal operation of the STATCLAVE requires a minimum amount of distilled water in BOTH the clean water reservoir and Venturi reservoir. To fill the Venturi reservoir: Open the Venturi reservoir lid located on the top left of the unit.

  • Page 20: Manual Filling Using Reservoir Top

    Manual Filling Using Reservoir Top With the unit powered ON, flip open the clean water reservoir lid located on the top right of the unit. Using a large container, fill with distilled water to the maximum fill line or until you hear three BEEPs. When adding water for the first time, the reservoir may take up to 1 US gal / 4 L.

  • Page 21: Manual Filling Using Quick Connector At Unit Front

    Manual Filling Using Quick Connector at Unit Front The front fill quick connector is for the refilling of the clean water reservoir. The Venturi reservoir does not have a front fill quick connector because it is only filled on installation or after cleaning. To use this method, you will need the manual fill container (0.5 US gal / 2 L) with quick connect and tubing (sold as an accessory).

  • Page 22: Automatic Filling Using A Vistapure Specialized Water Filtration System With Accumulation Tank

    Automatic Filling Using a VistaPure Specialized Water Filtration System with Accumulation Tank When connecting your STATCLAVE to an external filling device such as a VistaPure specialized water filtration system, make sure your unit is set to the AUTOMATIC filling mode. (See Section 4. Setting the water reservoir filling mode.) Remove the plug from the automatic fill port (A) at the back of the unit.

  • Page 23: Automatic Filling Using External Water Tank And Auxiliary Pump

    Automatic Filling Using External Water Tank and Auxiliary Pump When connecting your STATCLAVE to an automatic filling system such as an external water tank and auxiliary pump, make sure your unit is set to the AUTOMATIC filling mode. (See Section 4. Setting the water reservoir filling mode.) An input hose can be connected to the STATCLAVE from an external tank that uses an automatic water pump to feed the internal tank automatically when it reaches the MIN level.

  • Page 24: Loading Instruments

    Loading Instruments Before loading any instruments into the STATCLAVE, consult the instrument manufacturer’s reprocessing instructions to confirm instruments can tolerate steam sterilization temperatures. The following material can typically be sterilized with steam: › Stainless steel surgical/generic instruments › Carbon steel surgical/generic instruments ›...

  • Page 25: Using The Chamber Rack

    Using the Chamber Rack IMPORTANT! DON’T run the STATCLAVE without the chamber rack in place. Inserting the Rack Push the rack into the chamber until it locks into position at the back. The front of the chamber rack should be flush with the chamber flange.

  • Page 26: Wrapped Instruments

    DON’T use 100% cellulose sterilization wraps as pouches that have been cleared for your market. these may require longer drying times. IMPORTANT! To ensure optimal drying when using pouches, SciCan recommends the use of the STATCLAVE pouch racks supplied with your unit. Using Pouches Position pouches with the paper side towards the tall support on the pouch rack.
  • Page 27 Using Wrapped Cassettes and Containers Drying plates must be used when processing wrapped cassettes to ensure air flow around cassettes and to promote proper drying. For wrapped loads, place a chemical indicator inside each of the wrappings. Inserting drying plates Remove the wire trays from the unit and insert the drying plates into each of the slots in the base of the rack.

  • Page 28: Unwrapped Instruments

    Using Rigid Sterilization Containers The STATCLAVE is capable of processing re-usable rigid sterilization containers, which can be used as an alternative to wrapping cassettes. These provide a convenient way to organize and store instruments, and cut down on the waste involved with using paper wraps.

  • Page 29: Rubber And Plastic

    Rubber and Plastic The following materials CAN be sterilized in the STATCLAVE: › Nylon, polycarbonate (Lexan™), polypropylene, PTFE (Teflon™), acetal (Delrin™), polysulfone (Udel™), polyetherimide (Ultem™), silicone rubber, and polyester. When loading rubber and plastic tubing on the tray, make sure they do not touch the chamber walls.

  • Page 30: Using Your Statclave

    Using Your STATCLAVE Running a Cycle Once the autoclave has been correctly installed and before using your STATCLAVE for the first time, make sure BOTH the clean water reservoir and Venturi reservoir are full. Refer to Section 4. Filling the Water Reservoirs for detailed instructions. Power on the unit The main switch is located below the door handle.
  • Page 31 Close the door Close the door by locking the handle into position. When you close the door, you will hear the sound of the vacuum system adjusting chamber pressure to seal the door. This is a normal operating sound. Select the cycle From the LCD, select the cycle you want to run.

  • Page 32: Stopping A Cycle

    Remove the load Open the door. Remove the trays or pouch racks using the tray extractor provided with the unit. CAUTION! The metal parts will be hot. Stopping a Cycle CAUTION! If the screen displays a CYCLE FAULT code or a NOT STERILE message, the contents are not sterile. See Section 11 Troubleshooting for more information.

  • Page 33: Using The Delayed Start

    Opening the door after pressing STOP Once a cycle has been stopped, the STOP button must be pressed before another cycle can be started. To start a new cycle or to open the door: Press the STOP icon to continue. Press the LOCK icon.

  • Page 34: Emergency Door Opening

    Emergency Door Opening The STATCLAVE is equipped with a safety mechanism that automatically regulates the chamber pressure when the unit loses power. (The unit will take approximately 2 minutes to depressurize. Without power, the door lock will remain engaged.) To unlock the door without power, follow these steps: Remove the emergency door unlocking pin located in the handle of the tray extractor supplied with your STATCLAVE...

  • Page 35: Running A Bowie-Dick Test

    Running a Bowie-Dick Test The BOWIE-DICK test is used to ensure proper air removal is occurring in a pre-vacuum autoclave. Complete air removal is important because pockets of cool air remaining in the chamber can compromise sterilization. The Bowie-Dick test runs a cycle at 134°C / 273°F for 3.5 minutes to evaluate the correct air removal.
  • Page 36 Presetting your Bowie-Dick test To schedule a Bowie-Dick test before the start of the next working day, use the delayed start function. At the end of the working day, select the Bowie-Dick test. Press the DELAYED START icon. Enter the number of hours and minutes for the delayed start.

  • Page 37: Running A Vacuum Test

    Running a Vacuum Test The vacuum test checks the autoclave’s plumbing system for leaks and should be done on a regular basis in accordance to your local guidelines. Run this test with the rack and empty trays in the chamber. IMPORTANT! Vacuum tests must be conducted when the unit is cool.
  • Page 38 The custom cycle’s default cycle is 132C/270F for 4 minutes with 25 minutes of drying. To adjust the settings of this cycle, select SETTINGS then USER and follow these steps: From the Setup menu, scroll to Custom Cycle and select. From the Custom Cycle menu, press Cycle temperature.

  • Page 39: Sterilization Cycles

    Sterilization Cycles The STATCLAVE features 6 validated sterilization cycles with optimized drying for the fast, effective sterilization of the various types of loads used in a medical or dental environment. An additional custom cycle can be configured using one of three temperature settings but this cycle must be validated by the user.

  • Page 40: Using And Changing Settings

    Using and Changing Settings The STATCLAVE user menu provides you with access to settings that can be adjusted or changed. The chart below offers an overview of where these settings can be found within the menu structure and tells you what you can do with each button.
  • Page 41 Enter an email address to receive Online Access notifications. Agree: Your unit will send cycle data and unit errors to SciCan. It will also receive automatic software updates to the user interface. Privacy Disagree: Your unit will NOT send any cycle information but it will receive automatic software updates to the user interface.

  • Page 42: Setting Up Load Traceability With User Id, Pin, And Process Enforced Function

    Setting Up Load Traceability with User ID, PIN, and Process Enforced Function The Process Enforced function keeps track of who has started and who has removed a load from your STATCLAVE. It does this by prompting users to enter a PIN at the start of a cycle, when they STOP or CANCEL a cycle, and when they REMOVE a load.
  • Page 43 To turn Process Enforced Usage ON, OFF or to activate DOCUMENTATION mode, select SETTINGS then USER and follow these steps: Scroll to PROCESS and select. Select ENFORCED. Use the arrows to select one of the following: ON, OFF or DOCUMENTATION. Press the BACK icon to save your change and return to the main menu.

  • Page 44: Setting Drying Time

    At the end of the cycle, you will be prompted to report whether the indicators have passed and whether the load is dry (as applicable). Biological indicator/spore test results are available at a different time than chemical indicators but you still have the option to add the BI/spore test results to the documentation report when these results are available.

  • Page 45: Setting Up And Using Your Statclave Web Portal

    BACK icon to return to the previous menu. The STATCLAVE G4’s default setting is to maintain the unit at Stand-by HIGH from 7:00 a.m. to 8:00 p.m. For this feature to function correctly, your unit must be set to the correct time, date and country.

  • Page 46: Registering For Statclave Online Access

    Registering for STATCLAVE Online Access From the home screen, select SETTINGS then USER and follow these steps: Scroll to ONLINE and select. Select ONLINE ACCESS. To use ONLINE ACCESS, you must agree to the Privacy Policy. Then press FORWARD. Enter your email. A confirmation email will be sent to your inbox.

  • Page 47: Storing, Retrieving And Printing Sterilization Records

    Storing, Retrieving and Printing Sterilization Records The STATCLAVE’s internal memory is capable of storing data on every cycle, whether successful or incomplete, for the lifetime of the unit. You can access this information through the unit’s touchscreen, through the web portal, by using a USB storage device or by connecting a printer.

  • Page 48: Retrieving Cycle Information Using The Usb Data Back Up

    USB storage device. You can access previously transferred information from your STATCLAVE G4’s Web Portal. When the activity light on the USB storage device stops blinking or the USB icon on the LCD turns from a flashing green to a solid grey, remove the USB storage device and transfer the information to your computer.

  • Page 49: Connecting To A Printer

    Connecting to a Printer Some users may prefer to have a printed record generated after every cycle. To use an external printer you must connect it to the STATCLAVE’s RS232 port using the serial printer cable supplied with your printer. Once the printer is connected, enabled and its settings correctly adjusted (see below), it will automatically print a record of each cycle.

  • Page 50: 10. Maintenance Procedures

    Make sure the STATCLAVE is properly cooled before accessing the chamber to perform any maintenance. › DO always use SciCan replacement parts. › DON’T use abrasive cloths, metal brushes or metal-cleaning products, whether solids or liquids, to clean the device or sterilization chamber.

  • Page 51: Cleaning The Door Seal And Door Plate

    10.3 Cleaning the Door Seal and Door Plate Frequency: Daily CAUTION! Hot Chamber. The unit’s Stand-by mode is preset to maintain a hot chamber. Turn the unit off and allow adequate time for it to cool before performing maintenance. Using a clean, lint-free cloth dampened with water, wipe the door seal and door plate.

  • Page 52: Draining The Reservoirs For Cleaning

    10.6 Draining the Reservoirs for Cleaning IMPORTANT! Before shipping or servicing the unit, drain all water from the unit using these 3 ports. See Section 10.14 Preparing the Unit for Shipping. Use the waste bottle or arrange an empty 4-litre (1 gallon) container on the floor near the autoclave and insert the free end of the silicone drain tube (supplied with your STATCLAVE).

  • Page 53: Cleaning The Water Reservoirs And Reservoir Filters

    10.7 Cleaning the Water Reservoirs and Reservoir Filters Frequency: Monthly or every 100 cycles. To avoid accidental cross-contamination, always start with the clean water reservoir and complete steps 1-6 BEFORE cleaning the Venturi reservoir. Follow the draining instructions in Section 10.6 to drain the reservoirs completely. Using a soft bristle brush, scrub the corners and loosen any deposits.

  • Page 54: Cleaning The External Water Reservoir Tank

    10.8 Cleaning the External Water Reservoir Tank Frequency: Monthly or every 100 cycles. Disconnect the external tank from the autoclave and close the tank valve. Fill the tank with a solution of distilled water and alcohol (10%), such as isopropyl. Allow the solution to sit for 30 minutes.

  • Page 55: Replacing The Bacteriological Filter

    10.10 Replacing the Bacteriological Filter Frequency: Every 6 months or 500 cycles. Open the unit door. Unscrew the bacteriological filter. Replace it with a new filter. Tighten by hand only. CAUTION! A bacteriological filter must always be in place during a cycle. Running a cycle without a biological filter in place will compromise the sterility of the load.

  • Page 56: Enabling Remote Access For A Technician

    10.13 Enabling Remote Access for a Technician Technicians and other authorized personnel may want to connect to your STATCLAVE from a remote location to review its functioning or access stored information. To allow an external user to remotely access your STATCLAVE, you will need to provide a security token to the person requesting access.

  • Page 57: 11. Troubleshooting

    STERILE, Cycle aborted NOTE: STATCLAVE units connected to the Internet and registered — NOT STERILE and A power outage or power with SciCan will automatically send Cycle Fault messages to SciCan’s CYCLE FAULT messages. fluctuation occurred while the international service center.
  • Page 58 Problem Possible Cause Possible Solution The time and date are set on the date of manufacture but have not been Time and date are Unit was shipped to a new time adjusted for a new time zone. incorrect. zone. See Section 8. Using and Changing Settings. Re-insert the USB storage device and wait for the data to copy over again.
  • Page 59 Check the unit’s serial number to see if it was accurately updated after a Logic board configuration issue. logic board service. If number consists entirely of zeros, call SciCan. unit’s memory. Check for instrument or a cassette that is keeping the door from closing correctly.
  • Page 60 Error Code Possible Cause What you can check before calling for service Check door seal for obstructions. CF 4 Door seal leak. Check that the door seal is properly seated in the door channel. Check the exhaust tubing at the back of the unit to make sure it is not blocked or kinked.

  • Page 61: 12. Ordering Spare Parts And Accessories

    12. Ordering Spare Parts and Accessories Spare Parts 01-115481S Door seal, STATCLAVE G4 01-115479S Bacteriological air filter 01-115478S Chamber filter kit (3 filters) 01-115487S Chamber rack 01-115482S Mesh tray (1 pc) 01-115483S Pouch rack (1 pc) 01-115485S Tray extractor with door unlock pin (in handle)

  • Page 62: 13. Limited Warranty

    13. Limited Warranty For a period of two years or 2500 cycles, which ever appears first, SciCan guarantees that the STATCLAVE G4 Autoclave, 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 63: 14. Specifications

    14. Specifications Width: 17.75” / 450 mm Height: 19-19.5” / 483-495 mm Machine Dimensions: Depth: 25” / 635 mm Diameter: 11” / 280 mm Chamber Dimensions: Depth: 15” / 381 mm 6.9 US gal / 26 L/ Sterilization Chamber Volume: 1 US gal / 4 L Distilled Water Reservoir Volume: 1.6 US gal / 6 L...

  • Page 64: Appendix A - Software Icons

    APPENDIX A – Software Icons Network connection No Internet or network connection. Press to view detail. Network connection but no Internet connection. Press to view detail. Network and Internet connected. Press to view detail. USB icon variations: USB key not inserted. USB key inserted.

  • Page 65: Appendix B - Software Screens

    APPENDIX B – Software Screens Connectivity screen: PRESS to access network and Internet information Navigation icon: shows what page of the menu you are on. Network status QR code for quick access to G4 web portal using a mobile device. Internet status Connectivity information PRESS to move back one screen...
  • Page 66 APPENDIX B – Software Screens Door lock screen: PRESS to view door and lock status. Navigation icon: shows what page of the menu you are on. Current chamber pressure PRESS to unlock door Current door lock status: In this example, door shows closed and locked.

  • Page 67: Appendix C - Statclave Cybersecurity Statement

    APPENDIX C – STATCLAVE Cybersecurity Statement A network disruption or cybersecurity incident will not prevent this device from performing its primary function of completing a sterilization cycle. Additionally, a cybersecurity incident affecting the device cannot result in direct patient harm since the device does not come into contact with a patient.

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