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Summary of Contents for Coltene SciCan STATCLAVE G4
- Page 1 STATCLAVE G4 - ™ Chamber Autoclave OPERATOR’S MANUAL 95-115012 US EN R1. STATCLAVE G4 Operator’s Manual, Copyright 2019 SciCan Ltd. All rights reserved.
- Page 2 Quick Start Guide 1. Switch the 2. Ensure BOTH autoclave ON. reservoirs are filled with high quality distilled water. More information IN SECTION 4. IMPORTANT! Never Use Tap Water. 3. Ensure BOTH 4. Pull up on the drainage tubes door latch to are connected open the door.
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Page 3: Table Of Contents
Your STATCLAVE Storing, Retrieving and Printing Sterilization Records Checking the Package Contents Retrieving Cycle Information Using the Important Information About Using Touchscreen Your STATCLAVE Retrieving Cycle Information Using the Operating Principles, Key Features and Web Portal Safety Devices Retrieving Cycle Information Using the USB Unit Overview Data Back Up Touchscreen Overview... -
Page 4: 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 Wastewater bottle instrument trays 1 Chamber rack 1 Memory stick... -
Page 5: 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. - Page 6 Get to Know Your STATCLAVE: Read this Manual The details of installing, using and maintaining your STATCLAVE are all in this manual. Please read this manual before operating the unit and keep it for future reference. Users should follow the operating instructions and maintenance schedule described in this manual.
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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 Venturi reservoir drain operator Caution: Hot surface Clean water drain Caution: Danger of electric shock. Condenser drain (only used for Disconnect power supply when shipping and servicing) 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.
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Page 9: Unit Overview
Unit Overview 1. Wastewater reservoir drain quick-connect 8. Touchscreen (OUT) 9. Chamber rack 2. Warm air exhaust 10. Power cord input 3. Clean water reservoir drain quick-connect 11. Ethernet port (not visible) (OUT) 12. Automatic fill port for clean water reservoir 4. -
Page 10: Touchscreen Overview
Touchscreen Overview Home Screen Solid / Hollow / Solid / Unwrapped Unwrapped Wrapped System icons: Connectivity: Access network and Internet. USB: View cycle history. Door Lock: Unlock door. Settings: Access settings menu. Test Cycles Hollow / Rubber & Plastic and Wrapped Textiles/Porous Complete cycle information in Section 7. -
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. 1. PRESS lock icon. 2. PRESS unlock. 3. PRESS back. 4. Lock icon now changed to unlocked. -
Page 12: Set Up
Set Up Installing Your STATCLAVE 17.75” › Place the STATCLAVE on a flat level surface strong enough to support a 165 lbs (75kg) load. 7” › Allow for at least 7” (180 mm) of space ABOVE the unit to enable access to the reservoirs. If there is less than 7”... -
Page 13: Connecting And Powering Your Statclave
Connecting and Powering Your STATCLAVE 1. 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. 2. 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).
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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: 1. Set the waste bottle (D) on the ground or in the cabinetry below the unit. 2. - Page 16 Connecting to a Wireless Network From the unit’s home screen, select , 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.
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Page 17: Getting Started
Getting Started Preparing Your STATCLAVE for Use Once the STATCLAVE has been correctly installed, and before using it for the first time, make sure BOTH the clean water and Venturi reservoirs contain distilled water. The STATCLAVE uses the Venturi system to generate vacuum draws at the beginning and end of each cycle. Both reservoirs must contain the minimum required water levels for the unit to function. - Page 18 4. Open and fill the WASTEWATER RESERVOIR to the maximum fill level. 5. Open the door, plug the USB storage device into the USB port, and make sure the bacteriological filter is secured in place. CAUTION! Hot Chamber. The unit’s Stand-by mode is preset to maintain a hot chamber.
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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: 1. Open the Venturi reservoir lid located on the top left of the unit. 2. -
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. 2. Using a large container, fill with distilled water to the maximum fill line or until you hear 3 BEEPs. -
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 regular 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. 1. -
Page 22: Automatic Filling Using A Vista Pure Specialized
Automatic Filling Using a Vista Pure Specialized Water Filtration System with Accumulation Tank When connecting your STATCLAVE to an external filling device such as a Vista Pure specialized water filtration system, make sure your unit is set to the AUTOMATIC filling mode. (See Setting the water reservoir filling mode in Section 4.) Remove the plug from the automatic fill port (A) at the back of the unit. -
Page 23: Automatic Filling Using External Water
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 Setting the water reservoir filling mode in Section 4.) An input hose can be connected to the STATCLAVE from an external tank that uses an automatic water... -
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. CAUTION! Hot Chamber. -
Page 26: Wrapped Instruments
Wrapped Instruments If you plan to store your instruments after sterilization, wrap them according to the instrument manufacturer’s instructions, select the appropriate wrapped cycle and allow it to run to completion. Unwrapped instruments, once exposed to ambient or external conditions, cannot be maintained in a sterile state. - Page 27 › DO use the STATCLAVE pouch rack supplied › DON’T stack pouches or wraps. Instead, with your unit to position pouches on their sides. use the pouch rack to keep pouches vertical. This will promote drying and › DO always check that pouches are placed enable effective sterilization.
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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. Check the sterilization container manufacturer’s instructions to determine its suitability for pre-vacuum steam sterilization. -
Page 29: Rubber And Plastics
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, ensure they do not touch the chamber walls. This ensures that steam reaches all surfaces, and will promote drying. -
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. - Page 31 5. 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. 6.
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Page 32: Stopping A Cycle
8. Cycle is complete. When the cycle is complete, press STOP to release the load. IMPORTANT! When the drying stage is finished, the display will show the cycle is complete. 9. Remove the load Open the door. Using the tray extractor, remove the trays. -
Page 33: Using The Start Delay
Opening the door after pressing STOP Once a cycle has been stopped, the STOP button must be pressed to return to the home screen and start a new cycle. To start a new cycle or to release the load: If Process Enforced usage is enabled, a PIN screen will appear after you have pressed STOP. To release the load manually, press EN on the PIN screen. -
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. You will hear a bubbling sound as chamber air is exhausted into the wastewater reservoir. But, without power, the door lock remains engaged. -
Page 35: 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 36: 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. Using an FDA-approved Bowie-Dick test pack, the Bowie-Dick test runs a cycle at 134°C for 3.5 minutes to evaluate the correct air removal. -
Page 37: 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. The table below describes load types and corresponding sterilization requirements. Load size requirement details are listed in Section 5. -
Page 38: 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. Functions such as setting up load traceability, User IDs and PINs, setting drying times and Stand-by mode are explained in more detail later in this chapter. - Page 39 Button Beep Turn the beep ON or OFF Sound Adjust sound Beep Volume Instructions Water Reservoir Filters Slide show on how to clean the filters Solid/Unwrapped 132°C/4 min Adjust drying time (0 to 60 minutes) Solid/Wrapped 132°C/4 min Adjust drying time (0 to 60 minutes) Hollow/Unwrapped 132°C/4 min Adjust drying time (0 to 60 minutes) Drying...
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Page 40: Setting Up Load Traceability With User Id, Pin And Process Enforced Usage
Setting Up Load Traceability with User ID, PIN and Process Enforced Usage Process Enforced Usage 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 41 Using Process Enforced Documentation mode: This mode activates the process enforced usage function along with the additional documentation function that generates a report with information about the cycle and the load type. When starting a cycle with Process Enforced Documentation mode turned ON, you will be prompted to identify the general contents of the load to be processed by selecting from a list as well as whether a biological indicator and chemical indicator are included.
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Page 42: Setting Drying Time
Setting Drying Time Use this setting to select drying times. The default drying times for each cycle are preset to provide optimal drying of a maximum load. Drying times may be adjusted for smaller loads as detailed in Section 7. Sterilization Cycles. CAUTION! Instruments in pouches or wraps that are not completely dry must be used immediately or reprocessed. -
Page 43: Registering For Statclave Online Access
Setting Up and Using Your STATCLAVE Web Portal The web portal provides a direct connection to the STATCLAVE on your local area network. It is protected by your firewall and not accessible to outside users (unless they have a Remote Access Code. -
Page 44: 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 or through the web portal, and retrieved by using a USB storage device or by connecting a printer. Retrieving Cycle Information Using the Touchscreen You can always see the last five successful cycles and the last five incomplete cycles, whether you have a USB storage device attached to the unit or not. -
Page 45: Connecting To A Printer
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 gray, remove the USB storage device and transfer the information to your computer. IMPORTANT! If you select the USB storage device icon from the main menu, you will only be able to view the last five complete cycles and the last five incomplete cycles. -
Page 46: External Printer Specifications
Use the table below or your printer’s operator manual to make the correct adjustments to your printer’s Baud Rate, End of Line CR/LF and Printer User Char. External Printer Specifications Recommended Printer End Of Line CR/LF Serial Port Bitrate Printer user ° char Epson CR/LF 9600... -
Page 47: Maintenance Procedures
10. Maintenance Procedures Regular maintenance will ensure the safe and efficient operation of your STATCLAVE. Before performing any of the cleaning and maintenance procedures described in this chapter, power OFF the unit and disconnect it from its power source. CAUTION! Hot Surfaces. The STATCLAVE chamber’s Stand-by mode maintains an optimal operating temperature during working hours. -
Page 48: Cleaning The Door Seal And Door Plate
10.3 Cleaning the Door Seal and Door Plate Frequency: Daily 1. Using a clean cloth dampened with water, wipe the door seal and door plate. dry. 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. -
Page 49: Draining The Reservoirs For Cleaning
10.6 Draining the Reservoirs for Cleaning and Shipping IMPORTANT! Before shipping or servicing the unit, drain all water from the unit using these 3 ports. 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 50: Cleaning The External Distilled Water Tank
Once you have cleaned Repeat these steps both reservoirs, fill them to clean the Venturi with distilled water and reservoir. run one empty cycle. CAUTION! To avoid cross contamination, be sure to use a different cloth and container with solution to wipe the internal surfaces of each reservoir. 10.8 Cleaning the External Distilled Water Tank Frequency: Monthly or every 100 cycles. -
Page 51: Replacing The Bacteriological Filter
10.10 Replacing the Bacteriological Filter Frequency: Every 6 months or 500 cycles. 1. Open the unit door. 2. Unscrew the bacteriological filter. 3. Replace it with a new filter, hand tighten. CAUTION! A bacteriological filter must always be in place during a cycle. Running a cycle without a bacteriological filter in place will compromise the sterility of the load. -
Page 52: Using On-Screen Instructions
10.12 Using on-Screen Instructions The STATCLAVE on-screen help instruction can be found in the Setup menu. From the Home screen, select then and follow these steps: Press on the instructions you would like to view. Use the PAUSE icon To EXIT press to stop on anywhere on any image of... -
Page 53: Preparing The Unit For Shipping
10.14 Preparing the Unit for Shipping Most of the water can be drained from the system using the reservoir draining procedure described in Section 10.6 Draining the Reservoirs for Cleaning. In addition, the back panel condenser must also be drained. To drain the Condenser: Access the back of the unit to insert the quick-connect drain tube into the condenser draining port. -
Page 54: Troubleshooting
11. Troubleshooting Problem Possible Cause Possible Solution Check that the unit is plugged into a properly grounded outlet and that Unit does not power the power cord is firmly seated at the rear of the machine. Power cord or main power issue Try another circuit. - Page 55 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 adjusted for a new time zone. time zone. incorrect. See Section 8. Using and Changing your STATCLAVE’s Settings. Re-insert the USB storage device and wait for the data to copy over again.
- Page 56 Problem Possible Cause Possible Solution Instruments made of inferior materials can be prone to discoloration. Check the quality of the instruments that are spotting. Verify that they Low quality instruments can tolerate steam sterilization as per the instrument manufacturer’s instructions for use. Instruments must be free of debris prior to sterilization.
- Page 57 Error Code Possible Cause What you can check before calling for service Check door seal for obstructions. Check that the door seal is properly seated in the door channel. CF 4 Door seal leak. CAUTION! Surfaces may be hot. Check the exhaust tubing at the back of the unit to make sure it is not blocked or kinked.
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Page 58: 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 Trays (1 pc) 01-115483S Pouch Rack (1 pc) 01-115485S Tray Extractor with Door Unlock Pin (in handle) 01-115484S Drying plate (1 pc) 01-115488S... -
Page 59: Warranty Limited Warranty
13. Warranty 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 60: Specifications
14. Specifications Width: 17.75” / 450 mm Machine Dimensions: Height: 19-19.5” / 483-495 mm Depth: 25” / 635 mm Diameter: 11” / 280 mm Chamber Dimensions: Depth: 15” / 381 mm Sterilization Chamber Volume: 7 US gal / 26 L Distilled Water Reservoir Volume: 1 US gal / 4 L 1.6 US gal / 6 L... -
Page 61: Software Icons
APPENDIX A Software Icons Network connection No Internet or network connection. Press to view detail. Network 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. USB engaged and recording cycle information. -
Page 62: 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 USB screen:... - Page 63 APPENDIX B 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. PRESS to move back one screen Door lock breakdown: Door CLOSED, not latched...
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Page 64: 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. While the unit records, stores and sends (if connected to a network) information about a cycle, no patient data is stored on the unit.
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