Table of Contents
Related Manuals for Coltene SciCan STATIM B G4+
Summary of Contents for Coltene SciCan STATIM B G4+
- Page 1 B G4 STATIM ® Vacuum Autoclave Operator’s Manual Benutzerhandbuch Manuel de l’utilisateur - USB Manuale per l’operatore - USB 95-116177 EU EN R3. STATIM 6000B Operator’s Manual. Copyright 2021 Coltene SciCan. All rights reserved.
- Page 2 https://www.scican.com/eu/products/autoclaves/statim/ PDF reader software required. For a hard copy, contact SciCan GmbH at info.eu@scican.com PDF Lesersoftware erforderlich. Eine gedruckte Version erhalten Sie von der SciCan GmbH unter info.eu@scican.com Logiciel de lecture de PDF requis. Pour une copie papier, contactez SciCan GmbH à l’adresse info.eu@scican.com. È...
- Page 3 Quick Start Guide Switch the autoclave ON. Ensure there is high quality distilled water in the reservoir. IMPORTANT! Never Use Tap Water. More information in Section 2.4 Turn the latch to open the drawer. Check that both red drain tubes are installed. More information in Section 2.3 More information in Section 1.7 Insert the load.
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Page 4: Table Of Contents
Contents Your STATIM B Checking the Package Contents Important Information About Using your STATIM B Operating Principles, Key Features and Safety Devices Unit Overview Touchscreen Overview Using the Operation Screens Unlocking the Drawer Set Up Installing your STATIM B Connecting and Powering your STATIM B Connecting your STATIM B to a Drain or Waste Bottle Filling your STATIM B’s Water Reservoir Connecting your STATIM B to a Network... - Page 5 Using and Changing Settings Setting Up Load Traceability with User ID, PIN and Process Enforced Function Setting Drying Time Setting the Stand-By Mode Storing, Retrieving and Printing Sterilisation Records Retrieving Cycle Information Using the Touchscreen Exporting Cycle Information using the unit’s USB or Email Connecting to Online Storage Connecting to a Printer Cycle Printout - Full Cycle...
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Page 6: Your Statim B
1. Your STATIM B Checking the package contents 1 Instrument tray 1 Power cord 1 Waste water bottle Operator’s manual 1 Memory stick Direct-to-drain kit 2 Exhaust tubes 1 Pouch rack Important information about using your STATIM B Intended Use The STATIM B is a dynamic air removal (pre- and post-vacuum) table-top steam steriliser intended for use by a health care provider to sterilise medical products by means of pressurized steam. - Page 7 Get to Know Your STATIM B: Read this Manual The details of installing, using and maintaining your STATIM B 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 8: Operating Principles, Key Features And Safety Devices
Operating Principles, Key Features and Safety Devices The STATIM 6000B is a 6-litre tabletop autoclave that uses steam to sterilise wrapped and unwrapped instrument loads typically used in dental and medical offices as well as laboratories. It has 11 sterilisation programs each with a selection of holding times and each equipped with optimized drying for fast, effective sterilisation. - Page 9 Touchscreen › 5-inch touchscreen is one of the largest screens available for drawer-type autoclaves. With an 800 x 480 aspect ratio, the screen offers high resolution demonstrations and instructions. Its easy-to-clean glass surface is responsive to gloved fingers so you can scroll and swipe through menu features as you would on a smart phone.
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Page 10: Unit Overview
Unit Overview Reservoir top fill Dual USB ports Exhaust drain port Touchscreen Power port (5V DC) for Reservoir overflowdrain port optional external fill pump Drawer rack Bacteriological air filter (bacteria- Ethernet port retentive air filter) USB port Fuse reset buttons Pressure relief safety valve Drawer Power switch... -
Page 11: Touchscreen Overview
Touchscreen Overview Home screen Cycle count Network name USB key status Rubber and Solid / Unwrapped Plastic Test cycles Solid / Wrapped Universal Custom cycles Drawer lock status Cycle records Connectivity Settings Changing the display from light mode to dark mode Your STATIM B’s default screen mode is set to light. -
Page 12: Using The Operation Screens
Using the Operation Screens Select a cycle and then select the holding time. Press START NOW or DELAYED START. Cycle in progress. Unlocking the Drawer The STATIM B will lock the drawer when you select a cycle. To unlock the drawer, go to the home screen and press the flashing green lock icon: Lock Icon Drawer Latch Position... -
Page 13: Set Up
2. Set Up Installing Your STATIM B Height: 19.5cm / 7.7” Length: 61cm / 24” Width: 45cm / 17.75” 5 cm / 2” 5 cm / 2” 5 cm / 2” 5 cm / 2” 5 cm / 2” › Place the STATIM B on a flat, level, water resistant surface. -
Page 14: Connecting And Powering Your Statim B
Connecting and Powering Your STATIM B Ensure the power switch at the back 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 15: Connecting Your Statim B To A Drain Or Waste Bottle
Connecting Your STATIM B to a Drain or Waste Bottle The STATIM B produces waste water when the steam used to sterilise the load is exhausted from the chamber and condenses into water. This water can be drained from the unit into the waste bottle or directly to a connection on a drain pipe. - Page 16 Connecting to a Waste Bottle To connect the waste bottle to the STATIM B, follow these steps: Insert the exhaust tube into the fitting on the back of the unit and pull gently to confirm it is holding correctly. Cut the tube to length and slide the other end into the fitting on the bottle.
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Page 17: Filling Your Statim B's Water Reservoir
Filling Your STATIM B’s Water Reservoir When filling the reservoir, only use distilled or filtered water containing less than 5 ppm total dissolved solids (having a conductivity of less than 10 uS /cm). NOTE: Impurities and additives in other water sources will cause the water quality sensor to protect the unit by preventing a cycle from starting. - Page 18 Automatic Fill using a WATER FILTRATION SYSTEM When connecting your STATIM B to an external filling device such as a water filtration system, make sure your unit is set to the AUTOMATIC filling mode. (See section above on setting the water reservoir filling mode.) Connect the water filtration system’s Teflon tube (or other suitable tube) to the automatic fill...
- Page 19 Automatic Fill using an EXTERNAL WATER TANK AND AUXILIARY PUMP. When connecting your STATIM B 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 above on setting the water reservoir filling mode.) An input hose can be connected to the STATIM B from an external tank that uses an automatic water pump to feed the internal reservoir automatically when it reaches the minimum level.
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Page 20: Connecting Your Statim B To A Network
Manual Fill Your STATIM B’s default filling option is MANUAL. If you are manually filling the reservoir, you do not need to change the unit’s fill option settings. To manually fill the reservoir, follow these steps: Remove the reservoir cap. Pour distilled water into the reservoir until almost full (a maximum of 1.2 L (0.32 US gallons). - Page 21 Connecting to a Wired Network Connect Ethernet cable to port at back of unit. From the home screen, select the CONNECTIVITY icon. Confirm that the unit is connected to both the Network and Internet and press the back icon to return to the home screen. Data Security and WiFi Ensuring your WiFi connections are secure is an important element of safeguarding your organization’s...
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Page 22: Getting Started
3. Getting Started Preparing Your STATIM B for First-Time Use Check that the bacteriological filter is securely in place and that the two drain tubes are connected correctly. Power ON the unit by using the switch located on the back left. Follow the screen prompts to connect your STATIM B using either WiFi or an Ethernet cable connection. -
Page 23: Loading Instruments
4. Loading Instruments Before loading any instruments into the STATIM B, consult the instrument manufacturer’s reprocessing instructions to confirm instruments can tolerate steam sterilisation temperatures. The following materials can typically be sterilised with steam: › Stainless steel surgical/generic instruments › Carbon steel surgical/generic instruments ›... -
Page 24: Using The Drawer Rack
Using the Drawer Tray The drawer trays can be loaded while in the unit or removed and loaded on a counter. Lift the top tray out of the drawer to facilitate loading the lower tray. Once you have loaded the lower tray, place the top tray back into position making sure the tabs sit securely in each corner, then load the top tray. -
Page 25: Unwrapped Instruments
Using wrapped cassettes and containers For wrapped loads, place a chemical indicator inside each of the wrappings. When using wrapped cassettes: › DO ensure you always use suitably porous material (sterilisation paper, muslin napkins, etc.) and close the wrapping with adhesive tape designed for use in autoclaves. -
Page 26: Rubber And Plastic
Rubber and Plastic The following materials CAN be sterilised in the STATIM B: 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: ›... -
Page 27: Using Your Statim B
5. Using Your STATIM B Running a Cycle Power on the unit. The main switch is located on the back left of the unit. Ensure the reservoir is full. You will not be able to start a cycle if the reservoir level is below the minimum fill line. - Page 28 Close the drawer. Push the drawer closed and turn the latch. Select the cycle. From the LCD, select the cycle you want to run (to learn more about the available cycles, see Section 6. Sterilisation Cycles). Press the icon with the cycle time you want to see the cycle name and parameters.
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Page 29: Stopping A Cycle
Stopping a Cycle To stop a cycle BEFORE sterilisation is complete, press STOP on the touchscreen. If you stop the cycle before sterilisation is complete, the unit will remind you that the load is NOT STERILE. Press the STOP icon to continue to the home screen. - Page 30 Opening the drawer 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 drawer: Press the STOP icon to continue. Press the LOCK icon.
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Page 31: Using The Delayed Start
Using the Delayed Start Select any cycle to access the START screen. Press the DELAYED START button. Enter the time you would like the unit to start. Press the DELAYED START button to begin the countdown. The LCD will remain on the delayed start screen until the cycle begins. -
Page 32: Emergency Drawer Opening
Emergency Drawer Opening The STATIM B is equipped with a safety mechanism that keeps the chamber locked when the unit loses power during a cycle. To unlock the drawer without power, follow these steps: Wearing heat-resistant gloves, pull up on the pressure relief valve ring at the back right of the unit to exhaust steam from the chamber. -
Page 33: 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 sterilisation. The Bowie-Dick test runs a cycle at 134°C / 273°F for 3.5 minutes to evaluate the correct air removal. To perform a Bowie-Dick test, you will need a Bowie-Dick device or test pack. - Page 34 Press the STOP icon to open the drawer. Follow the test manufacturer’s instructions to interpret the test results. If the unit passes the test, it is ready for use. If the unit fails, check the test manufacturer’s instructions and repeat the test. If the second test fails, contact your service technician.
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Page 35: Running A Helix Test
5.6 Running a Helix Test To perform a Helix test, you will need a Helix device or test pack. These are NOT supplied with your STATIMB. To perform the test, follow the instructions provided by the test pack manufacturer. Generally, the process is as follows: Open the drawer to insert a Helix test pack. -
Page 36: 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 empty trays in the chamber. Test should be done on a cold chamber. -
Page 37: Using The Custom Cycle
Using the Custom Cycles The custom cycles can be used to accommodate the sterilisation of instruments requiring cycles with parameters that are different from the unit’s preset cycles. Users can define parameters for custom cycles according to the instrument manufacturer’s instructions by choosing from a list of temperatures, sterilisation times and drying times to create up to two unique cycles that can be made accessible from the main menu. -
Page 38: Sterilisation Cycles
6. Sterilisation Cycles The STATIM B features 11 validated sterilisation cycles with optimized drying for the fast, effective sterilisation of the various types of loads used in a medical or dental environment. Two additional custom cycles can be configured using two temperature settings but these cycle must be validated by the user. The table below describes load types and corresponding sterilisation requirements. -
Page 39: Using And Changing Settings
7. Using and Changing Settings The STATIM B features several settings that can be adjusted. The chart below provides an overview of where these settings can be found within the menu structure and tells you what you can do with each button. -
Page 40: 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 documents who has started and who has removed a load from your STATIM B. 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 To turn Process Enforced Usage ON, OFF or to activate DOCUMENTATION mode, select SETTINGS and follow these steps: Scroll to PROCESS and select. Use the side menu to select one of the following: Standard: Process enforced is OFF. Enforced: Process enforced is ON. Documentation: Process enforced is ON and asks for additional load contents details.
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Page 42: Setting Drying Time
Setting Drying Time Use this setting to lengthen or shorten drying times on selected cycles. The default drying times for each cycle are pre-set to provide optimal drying of a standard load. Loads must always be checked for dryness. To change drying times, select SETTINGS then CYCLES and follow these steps: Setting the Stand-By Mode Using this setting will reduce the warm-up time between cycles by keeping the chamber at a temperature that is optimal for your office’s level of use. -
Page 43: Storing, Retrieving And Printing Sterilisation Records
You can access this information through the unit’s touchscreen, by exporting to a USB storage device or to an email address, or by connecting a printer. Coltene-SciCan also provides a cloud- based service that will automatically upload your unit’s cycle data to an online storage service for safe off- site record keeping. -
Page 44: Exporting Cycle Information Using The Unit's Usb Or Email
Exporting Cycle Information Using the Unit’s USB or Email You can use your unit’s USB storage device or an email address to send cycle information stored in the unit to a computer. Best practice suggests this should be done once a week. To transfer data using the USB port, follow these steps: Insert the USB storage device into one of the unit’s USB ports (front or back). - Page 45 To transfer data to an email address, follow these steps From the Cycle Log screen, press the FOLDER icon. Press the EXPORT icon. Select export to Email and press the check mark. Enter an email address and press NEXT to start the export.
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Page 46: Connecting To Online Storage
Connecting to Online Storage To use the SciCan-managed cloud service (www.updates.scican.com) for storing your unit’s cycle data, you will have to connect your unit to the Internet and register for online access using the unit’s Set Up Wizard. The Setup Wizard will prompt you to enter your SciCan account information to connect your unit to online record storage. -
Page 47: 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 one of the unit’s two USB ports at the back. Once the printer is connected, enabled and its settings correctly adjusted (see below), it will automatically print a record of each cycle. -
Page 48: Cycle Printout - Full Cycle
Cycle Printout - Full Cycle Software: Revision 100 STATIM 6000B SDS2R100 Model: STATIM 6000B Serial Number: 310800A03600 SN 310800A03600 Unit Identifier: Autoclave has UNIT # : been set up as number 000 WATER QUALITY Quality of water in reservoir 5.2uS / 3.3ppm CYCLE NUMBER 000043 Cycle counter: the number... -
Page 49: Cycle Printout - Stop Button Pressed
8.6 Cycle Printout - Stop Button Pressed Software: SDS2R100 Model: STATIM 6000B STATIM 6000B SDS2R100 Serial Number: 310800A03600 SN 310800A03600 Unit Identifier: Autoclave has UNIT # : been set up as number 000 WATER QUALITY Quality of water in reservoir 5.1uS / 3.2ppm CYCLE NUMBER 000040... -
Page 50: Maintenance Procedures
9. Maintenance Procedures Regular maintenance will ensure the safe and efficient operation of your STATIM B. 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 ›... -
Page 51: Cleaning And Disinfecting The External Surfaces
Cleaning and Disinfecting the External Surfaces Frequency: Clean daily. Disinfect weekly. Clean and disinfect all of the STATIM B’s external parts using OPTIM wipes or a clean, lint-free ® cloth dampened with water and, if needed, a mild detergent. Dry the surfaces and remove any residue before powering ON the unit. -
Page 52: Draining The Reservoir
Draining the Water Reservoir Frequency: Weekly, or Daily for ophthalmic use To reduce the build up of bio film and other adverse water reservoir conditions, drain the water reservoir at the end of the work week, or at the end of every workday for ophthalmic use. From the home screen, select SETTINGS and follow theses steps: Select SYSTEM. -
Page 53: Replacing The Bacteriological Air Filter
Replacing the Bacteriological Air Filter Frequency: Every 6 months or 1,000 cycles (whichever is first) Access the back of the unit. Unscrew the bacteriological air filter. Replace it with a new filter. Tighten by hand only. CAUTION! A bacteriological filter must always be in place during a cycle. -
Page 54: Replacing The Drawer Seal
Replacing the Drawer Seal Frequency: Every 6 months or 1,000 cycles (whichever is first) Open the drawer and unhook the tray to slide it into the chamber and out of the way. Remove the old seal by pulling it out of position. -
Page 55: Using On-Screen Instructions
9.10 Using On-Screen Instructions The STATIM B on-screen help instructions can be found in the SETTINGS menu. From the home screen, select SETTINGS Press the INFORMATION icon Press INSTRUCTIONS. Select the instructions you would like to view. Press the X to stop the video. -
Page 56: Enabling Remote Access For A Technician
9.11 Enabling Remote Access for a Technician Technicians and other authorized personnel may want to connect to your STATIM B from a remote location to review its functioning or access stored information. To allow an external user to remotely access your STATIM B, you will need to provide a security token to the person requesting access. -
Page 57: Troubleshooting
10. Troubleshooting Problem Possible Cause What you can check before calling for service Check that the unit is plugged into a properly grounded outlet and that the power cord is firmly seated at the rear of the machine. Power cord or main power No power Try another outlet. - Page 58 Problem Possible Cause What you can check before calling for service Drawer will not Power failure Use the emergency drawer unlock procedure described in Section 6. open – no power The warm unit cooled down Drawer will not overnight creating a vacuum Turn the unit ON and it will adjust the chamber pressure to allow the open - power OFF that is holding the drawer...
- Page 59 Problem Possible Cause What you can check before calling for service Improper loading NOTE: For optimal drying, allow the cycle to continue to completion. Wrong cycle selection for this Instruments do Make sure the instruments are loaded correctly in the chamber. Refer to particular load not dry.
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Page 60: Ordering Spare Parts And Accessories
11 Ordering Spare Parts and Accessories Spare Parts 01-116292S Air Filter 01-116293S Drawer Seal, 6L 01-116294S Tray, 6L 01-116296S Exhaust Tube 01-116297S Extended Exhaust Tube 01-116298S Direct-to-Drain 01-116299S Water Filling 01-116300S Waste Bottle 01-116301S USB Memory Stick 01-116302S Water Reservoir Cap SCI-BDSK134V Bowie-Dick Test Kit 97902001... -
Page 61: Limited Warranty
12 Limited Warranty For a period of 2 years or 4,000 cycles, which ever appears first, SciCan guarantees that the STATIM B 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. The five year warranty will cover the performance of all components of the unit except consumables such as the bacteriological filter, reservoir filter and trays, and provided that the product is being used and maintained according to the description in the operator’s manual. -
Page 62: Specifications
13 Specifications Width: 45 cm / 17.75” Machine Dimensions: Height: 19.5 cm / 7.7” Depth: 61 cm / 24” Width: 21 cm / 8.25” Drawer Dimensions: Depth: 30 cm /11.8” Sterilisation Chamber Volume: 6L (61 cubic inches) Distilled Water Reservoir Volume: 1.2L (0.32 US gal) Weight (without water): 24 kg (54 lbs) -
Page 63: Sterilisation Cycle Profiles - Graph Format
14 Diagrams of Cycle Profiles 121ºC Cycle Profile Pressure 134ºC Cycle Profile Pressure... -
Page 64: Declaration Of Conformity
15 Declaration of Conformity Classification: Class IIa (MDD Annex IX, Rule 15) Manufacturer: SciCan Ltd. Manufacturer Address: 1440 Don Mills Road Toronto, Ontario M3B 3P9 / Canada +1 416-445-2727 Telephone +1 416-445-1600 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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