95-113364 US EN R2 STATIM 2000 G4 5000 G4 OpMan 20140904
Contents
1. E 3 192 168 162 157 index html m bj Maps amp SciCan Wiki Deb Group fal White Paper fal ID Techniques fal Al Techniques fal PS Techniques SciCan Your Infection Control Specialist gt PECIANST A A Page 17 3 Setting up your STATIM 3 19 Connecting to a Network The STATIM G4 has a 10 100Base T Ethernet port located at the back of the unit To connect your STAT M to a network using a router follow these steps 1 Connect your network cable to the Ethernet port at the back of the unit If your office uses a router the router should automatically assign the unit an IP address You will know the IP address has been assigned when the red X over the Network icon disappears NOTE In some circumstances where you do not have a router for example when using Windows Network Sharing you may have to assign a dedicated or static IP address To assign a static IP address contact your local network administrator 2 From the main screen press the Network icon The Network screen displays information about your STAT M s connectivity including its IP address MAC 0004a32ddf4a DHCP Link ON mm dd yyyy hh mm ss SELECT A CYCLE n PZJA GATE 192 168 163 2 DNS1 192 168 163 25 3 Type the IP address displayed on the touchscreen into the browser of any web enabled device to access your unit s web portal You will know that an IP address has been assigned when the red X over the Network ic2. 1 Align the hinge tab on the lid with the hinge slot on the tray 2 As you begin to close the lid the hinge tab and slot will engage 3 Place the carry handle 27 into the closed position e Inserting the Cassette into the STAT M 5000 G4 1 Hold the cassette handle in one hand and the carry handle in the other as shown in Figure 8 2 Place the end of the cassette into the unit and drop the carry handle into its closed position Figure 8 3 Gently push inward until you hear a click sound and check the LCD icon for change from v to E Never force the cassette into the STAT M as the interior components could be damaged NOTE The main menu screen will display v if the cassette is not properly inserted in the unit Page 21 4 Using Cassettes and Preparing Instruments 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 3 Pull the cassette clear from the unit and set down on a firm surface Disengaging the cassette and pull the cassette out until there is a 15 mm to 20 mm 1 2 to 3 4 gap between the front of the When not in use the cassette should be disengaged To disengage the cassette grasp the handle E STAT M 5000 G4 and the cassette handle 4 3 Using Drying Plates with the STAT M 5000 G4 The STAT IM 5000 G4 cassette comes with two racks
3. The water quality is continually monitored by your STAT M to ensure that only steam process distilled water is being used If the water quality is beyond the tolerances specified above a red X will appear on the water icon ce of the cycle select screen Press the icon to go to the next screen to confirm that it is a water quality issue and not a water level issue If the water quality not suitable 3 will appear next to micro S and parts per million values Using the drain tube see Section Priming the Pump Figure 6 empty the contents of the reservoir into the water container and replace with steam process distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm 9 9 Using On Screen Instructions The STATIM G4 on screen help instruction can be viewed by following these steps 1 ak ae A E gt E 2 Scroll to and select 3 Choose the Instructions you would like to view and select Page 44 9 Maintaining your STATIM 9 10 Preventative Maintenance Schedules 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 Operator Daily Weekly Water Reservoir Replace water as needed For opthalmic
4. Page 33 5 Using your STATIM 5 4 STATIM 2000 5000 G4 Running a Cycle When the cycle starts the cycle parameters are displayed at the top of the screen Below it is the current phase The unit s cycle counter is displayed at right A graph charts the progress of the cycle while current cycle information is displayed at right As the cycle is running various sounds will be heard This is the normal functioning of the unit Example of sterilization cycle phases in STATIM 2000 G4 UNWRAPPED 135 C for 3 5 min CYCLE NUMBER UNWRAPPED 135 C for 3 5 min WARMING UP UNWRAPPED 135 C for 3 5 min CONDITIONING UNWRAPPED 135 C for 3 5 min PRESSURIZING __ UNWRAPPED 135 C for 3 5 min STERILIZING UNWRAPPED 135 C for 3 5 min VENTING 138 Page 34 o Using your STATIM 5 4 STATIM 2000 5000 G4 Running a Cycle When the cycle is running an intermittent buzzing sound will be heard as the pump injects water into the steam generator A random clicking sound will also be heard as the exhaust valve opens and closes Once the sterilization cycle is complete a reminder tone will sound as the cycle moves into the Air Drying phase 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 then read STOP BUTTON PRESSED CYCLE COMPLE
5. 01 112385S Cassette Tray 5000 G4 Cassette Handles Tray Lid 01 112509S Cassette Complete 5000 Ext G4 01 1123875 5000 G4 01 112510S Cassette Tray 5000 Ext G4 01 112388S Cassette Handle Lid 5000 G4 01 101709S Mesh Rack STAT M 5000 01 112511S Cassette Lid 5000 Ext G4 01 106325 Container Endoscope Complete Cassette Handles Tray Lid STAT M 5000 01 112512S 5000 Ext G4 01 103935 Drying Plates Aty 5 Cassette Handle Lid STATIM 5000 011125159 5000 Ext G4 C 01 103923 Condenser Additional Bottle J 01 101787S Reservoir Cap and Filter 01 100812S Condenser Bottle 01 100724S Condenser Bottle w o Condenser 01 100735S Waste Water Bottle Fitting 01 100204S Exhaust Tube 01 100207S Compressor Filter 2000 01 101652S Air Compressor Filter 5000 01 102119S Filter Biological 01 109300S Water Reservoir Filter Kit 01 104343S Plug Drain Tubing 01 100780S Bumper 01 101647S Power Cord North America J 12 Warranty Limited Warranty For a period of one year SciCan guarantees that the STAT M 2000 5000 G4 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 one year warranty will cover the performance of all components of the unit except consumables such as the cassette seal the compressor filter and the microbiological filter provided that the product i
6. MAC 0004a32ddf4a P mm dd yyyy hh mm ss SELECT A CYCLE NOTE Accessing this screen will vary for each router please consult your router s User Manual or contact your network administrator for more detailed instructions SciCan currently recommends D Link DIR 615 Wireless N router 2 Use the DHCP IP Address Reservation function to assign your STATIM a permanent IP address NOTE Each manufacturer may use different nomenclature this setting may be called HCP Reservation IP Reservation or Address Reservation 3 You will have to select the appropriate device to apply this setting Your unit s default name will be Statim_ IMPORTANT Please contact your network administrator for more detailed instructions Page 19 4 Using Cassettes and Preparing Instruments 4 1 Using the STATIM 2000 G4 Cassette When removing the cassette after a cycle exercise caution as the metal areas will be hot and the cassette may contain hot steam Opening the Cassette cassette latch 1 Hold the cassette handle with your thumbs facing inward on the cassette latch 2 Push downward on the cassette latch 3 Raise the cassette lid upwards and disengage the hinge 4 Rest the lid on its outer surface Figure 7 Closing the Cassette 1 Align the hinge tab on the cassette lid with the hinge slot on the rear of the bottom tray 2 As you begin to close the lid the hinge tab and slot will engage e Inser
7. 13 1 STAT M 2000 G4 13 2 STAT M 5000 G4 STATIM Cassette Autoclave and STAT M are registered trademarks and Your Infection Control Specialist DriTec and DriTec lt logos are trademarks of SciCan Ltd All other trademarks referred to in this manual are the property of their respective owners For all service and repair inquiries In Canada 1 800 870 7777 United States 1 800 572 1211 Email techservice ca scican com Manufactured by SciCan Ltd 1440 Don Mills Road Toronto ON M3B 3P9 CANADA Phone 416 445 1600 Fax 416 445 2727 Toll free 1 800 667 7733 Page 2 SciCan Inc 701 Technology Drive Canonsburg PA 15317 USA Phone 724 820 1600 Fax 724 820 1479 Toll free 1 800 572 1211 1 Introduction STAT M 5000 G4 Dri Tec STATIM 2000 G4 A BS Congratulations on selecting the STATIM Cassette Autoclave The STATIM is a compact countertop unit that is suitable for steam sterilization The details of installing operating and maintaining your STAT M are all contained within this operator s manual Please read these instructions before operating this unit and keep them for future reference Operational maintenance and replacement instructions should be followed Contents of this manual are subject to change without notice to reflect changes and improvements to the STAT M product The STATIM is suitable for the sterilization of dental and medical instruments designed to withstand stea
8. A potential hazard ae Important in the margins of this book to the operator ees eae je information mechanical failure START STOP The following symbols may appear on the unit gt BUTTON BUTTON Caution Hot Surface and or Caution Refer to user 0 UNWRAPPED qi WRAPPED Hot Steam manual for details y CYCLE al CYCLE ema aera Steam distilled water only G AIRDRY ONLY fy RUBBER AN l PPly do not use tap water CYCLE PLASTIC CYCLE before servicing When you receive your STAT M 2000 G4 the items listed below will be included If any of the items are missing contact your dealer immediately Cassette Tray and Lid Operator s Manual Instrument Rack Exhaust Tube Waste Bottle USB Memory Stick Bottle Lid Fitting Power Cord Tube Mounting Hardware Page 5 2 Important Information 2 3 STATIM 5000 G4 Unit Overview LCD Touchscreen Reservoir cap water filter USB port Power switch Power cable port a Leveler feet Exhaust tube port E Biological filter g Cassette RS232 port Ethernet port Air filter The following symbols appear A potential hazard Ses Important in the margins of this book to the operator ea cities failure information The following symbols appear on the unit D START STOP BUTTON BUTTON Caution Hot Surface and or Caution Refer to user ge UNWRAPPED Tm WRAPPED Hot Steam manual for details VJ CYCLE Vel CYCLE ia ent pos Steam distilled water only x jn sad m
9. Ibs of solid and hollow metal om instruments which have been sealed in paper paper or paper plastic autoclave bags Dental hand pieces may be sterilized in this cycle To select the Wrapped Cycle press the Wrapped Cycle button then press the START button Warming up Sterilizing Conditioning Venting Pressurizing Air Drying The sterilization temperature in the cassette is 132 C 270 F and the holding time is 6 minutes See Section 4 4 Preparing and Loading Instruments before running this cycle If wrapped instruments are intended for storage the wraps must be dry when the cassette is removed from the unit and opened m 5 3 3 Rubber and Plastics Cycle STATIM 5000 G4 The Rubber and Plastics Cycle is used to sterilize up to 0 4 kg 0 9 Ibs of solid or hollow unwrapped Instruments constructed of metal or the materials listed in Section 4 4 Preparing and Loading Instruments To select the Rubber and Plastics Cycle press the Rubber and Plastics Cycle button then press the START button Warming up Sterilizing Conditioning Venting Pressurizing Air Drying The sterilization temperature in the cassette is 121 C 250 C and for the holding time is 35 minutes Page 30 5 Using your STATIM 5 3 4 Heavy Duty Unwrapped Cycle STATIM 5000 G4 The Heavy Duty Cycle is used to sterilize larger m loads of unwrapped metal instruments weighing up to 1 5 kg 8 3 Ibs Dental hand pieces ca
10. Process Enforced Setup PIN PIN Setup User x DAB PIN Updated poo ai Themes Themes Statim Silver Upgrade Theme Upgrade Theme Upgrade Theme PLEASE WAIT 204 B091 Looking for Theme P04 B092 204 B093 204 B094 Done Screensaver LCD Contrast Network Settings Automatic IP DHCP FI OFF Renew IP DHCP LINK OFF Bind dhcp IP 0 0 0 0 Button Beep Beep Volume Remote Access Remote Access Token 341b3a32 Instructions 3 Setting up your STATIM 3 1 Positioning and Powering your Unit Positioning your Unit There are several factors that may affect the performance of your STAT M Please review these factors and select a suitable location in which to install the unit e Temperature and Humidity Avoid installing your STAT M in direct sunlight or close to a heat source e g vents or radiators The recommended operating temperatures are 15 25 C 59 F to 77 F with humidity of 25 70 e Spacing The vents and openings on the STAT M should remain uncovered and unobstructed Leave a minimum of 50 mm 2 between the top sides and back of the unit and any wall or partition For more detailed information on clearances see Section 13 Specifications e Venting The STAT M should be operated in a clean dust free environment e Work Surface Your STATIM should be placed on a flat level water resistant surface N
11. RUBBER l ap PPly do not use tap water PLASTIC CYCLE before servicing CYCLE When you receive your STAT M 5000 G4 the items listed below will be included If any of the items are missing contact your dealer immediately Cassette Tray and Lid L Power Cord lt lt lt N Nee LN t Unwrapped Instrument Rack Operator s Manual Waste Bottle Exhaust Tube Bottle Lid Fitting USB Memory Stick Tube Mounting Hardware SIS Wired Pouch Rack Rack with Drying Plates Page 6 Unwrapped cycles Wrapped cycles Rubber Plastic cycles Ae Pry Only 2000 A eavy Duty Unwrappe J 5000 a Display mm dd yyyy hh mm ss SELECT A CYCLE USB storage device connected not connected turns green when active Water level and quality status Cassette properly inserted _ Network connectivity No connection C7 Connected to network but no internet C3 Connected to network and internet information Page 7 Settings and unit Stop button 2 5 Setup Menu Overview Z DD MM YY 01 01 2011 DST On Off mm dd yyyy hh mm ss SELECT A CYCLE 12h 24h Setup Date Format MM DD YYYY Language Unit No xx x uS XX X ppm WATER LEVEL Printer type Serial Printer Baud rate End of line CR LF Page 8 2 5 Setup Menu Overview Printer user char
12. pouches Pouches that have been cleared by the FDA for use with the respective cycle time and temperature of the STAT M 2000 5000 G4 Cassette Autoclaves must be used The use of cloth wraps in the STAT M is not recommended Loosely pack instruments in the bags to allow steam penetration to all instrument surfaces Care must be taken to ensure that the combined weight of the loaded bags does not exceed 1 5 kg 3 3 Ibs for STATIM 5000 G4 or 1 0 kg 2 2 lbs for STATIM 2000 G4 For STAT M 2000 G4 PL aci a T lt m MM AEA a The rack with drying plates will hold 10 autoclave bags Rubber and Plastic Instruments 4 The following materials can be sterilized in the STATIM e Nylon e Polycarbonate Lexan e Polypropylene PTFE Teflon e Acetal Delrin e Polysulfone Udel e Polyetherimide Ultem e Silicone e Rubber e Polyester When loading rubber and plastic instruments in the tray leave a space between the instruments and the cassette walls This ensures that steam reaches all surfaces and will promote drying Page 23 4 Using Cassettes and Preparing Instruments The following materials CANNOT be sterilized in the STAT IM e Polyethylene e ABS e Styrene e Cellulosics e PVC e Acrylic Plexiglas e PPO Noryl e Latex e Neoprene and similar materials Use of these materials may lead to instrument or equipment damage If you are
13. tube is secured Remove and reinsert the cassette Attempt another cycle Be careful The metal parts will be hot and the cassette will contain hot steam The cassette is leaking If water drips from the underside of the unit during operation check the cassette seal for misalignment or damage and replace the seal if required Be careful The metal parts will be hot and the cassette will contain hot steam Attempt another cycle If it still leaks attempt another cycle using a different cassette if possible If the leak persists turn the unit OFF remove and unload the cassette unplug the unit and call your dealer Instruments do not dry Best drying occurs when the cycle continues to completion Allow the cycle to finish Make sure the instruments are loaded correctly in the cassette Refer to Section 4 4 Preparing and Loading Instruments Check the unit leveling Check air biological filters and replace if dirty Examine the exhaust tube tube to the waste bottle for kinks If kinked straighten the tube If the tube cannot be straightened remove it from the push in fitting attached to the STAT M 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 Be sure that you leave enough tube to reach the unit when you re attach the tube to the exhaust fitting If the tube is too short to rem
14. 2000 G4 The Rubber and Plastics Cycle is used to sterilize up to 0 4 kg 0 9 Ibs of solid unwrapped instruments constructed of metal or the materials listed in Section Preparing and Loading Instruments To select the Rubber and Plastics Cycle press the Rubber and Plastics Cycle button then press the E START button Warming up Sterilizing Conditioning Venting Pressurizing Air Drying RUBBER PLASTICS Press START The sterilization temperature in the cassette is 121 C 250 F and the holding time is 15 minutes Page 27 5 Using your STATIM 5 2 4 Air Dry Only Cycle STATIM 2000 G4 This is not a sterilization cycle The load is considered sterile after the successful completion of the sterilization phase of the cycle Z The Air Dry phase starts automatically after each sterilizing cycle and runs for 60 minutes Air drying may be interrupted by pressing the STOP button anytime after the sterilization phase of the cycle is complete To ensure that the contents of the cassette are dry the cycle should run for the full 60 minutes Dryness is important for unwrapped instruments for corrosion prevention For wrapped instruments a dry wrap is required to maintain sterility If the STOP button is pressed during the air drying stage of the sterilization cycle and the cassette has not been removed from the autoclave the Air Dry Only cycle may be used to promote further drying If the cassette has been remo
15. 3 in diameter in the countertop and secured with the provided nylon clamps Figure 4 Page 12 3 Setting up your STATIM 3 4 Filling the Water Reservoir When filling the reservoir ensure you only use steam processed distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm The impurities and additives in other water sources will cause an error reading on the LCD To fill the reservoir follow these steps See Figure 5 1 Remove the reservoir cap fi 2 Pour steam process distilled water into the reservoir until almost full a maximum of 4L 1 U S gal Use a funnel to avoid spillage 3 Replace and secure the cap 3 5 Priming the Pump To prime the STAT M pump follow these steps see Figure 6 1 Move the unit to the edge of the work surface The front leveler feet should be approximately 12 mm 0 5 from the edge 2 Lift the front left corner of the unit upward and remove the drain tube PJ from the clip located on the underside of the unit 3 Pull the drain tube outward so the free end can be positioned over a water container 4 Fill the reservoir with steam process distilled water 5 Remove the plug Eg from the end of the drain tube and allow water to drain from the tube into a container for 30 seconds When the water flows in a steady stream replace the stopper 6 Lift the front left corner of the unit upward and reinsert the tube into the clip on t
16. If you would like to learn more about SciCan products and features visit our website at www scican com Page 51 13 Specifications 13 1 STATIM 2000 G4 Machine Dimensions Length 500 mm 19 6 Width 414 mm 16 3 Height 157 mm 6 2 Cassette Size External Length 410 mm 16 includes handles Width 195 mm 7 7 Height 40 mm 1 6 Cassette Size Internal Length 280 mm 11 Width 180 mm 7 1 Height 35 mm 1 4 Sterilization Chamber Volume 1 8 L 61 fl oz U S Reservoir Volume 4 0 L 140 fl oz U S Weight Without water 21 kg 46 Ibs Clearance required Top 50 mm 1 9 Sides 50 mm 1 9 Back 50 mm 1 9 Front 480 mm 18 9 Maximum Steam Temperature 138 C 280 F Maximum Operating Pressure 341kP abs 49 5 psia Electrical Rating 10 100 V 50 60 Hz 11A 110 V 50 60 Hz 11A 220 240 V 50 60Hz 6A see serial number label for requirements specific to your unit Ethernet Port 10 100 Base T USB Port USB 2 0 Protection Class Protection covered indoor use only Ambient Operating Temperature and Humidity 15 C to 25 C 59 F to 77 F and 25 to 70 Max Altitude Up to 2000 meters 6600 ft Installation Category 1 Page 52 13 Specifications 13 2 STATIM 5000 G4 Machine Dimensions Length Width Height Cassette Size External Length Width Height Extended Cassette Size External Length Width Heig
17. LE FAULT 12 NOT STERILE NOT STERILE PRESS STOP TO RESET REMOVE CASSETTE REMOVE CASSETTE PRESS STOP TO RESET If the display shows the message CYCLE FAULT or NOT STERILE the cassette contents are not sterile See Section 10 Troubleshooting for more information If the cassette contains wrapped instruments and the wraps are not dry when the cassette is open the instruments must be handled in an aseptic manner for immediate use and should not be stored Page 36 6 Storing and Retrieving Cycle Information The STAT IM G4 has an internal Data Logger capable of storing all cycle data on every cycle whether successful or incomplete for the lifetime of the unit You can access this information through the touchscreen through the web portal using a USB storage device or by attaching a printer 6 1 Retrieving Cycle Information Using the Touchscreen 1 From the main menu press a l 2 The unit will record the last five successful cycles and the last five incomplete cycles If you select a cycle from the list it will display cycle information in a format similar to how it would be printed 3 Use the arrow keys to scroll through and read NOTE Regardless of whether you have a USB storage device attached to the unit or not you can always see the last five successful cycles and the last five incomplete cycles Use the STAT M G4 web portal to access all the cycle information stored on your STAT M from your computer To connect your STA
18. STAT IM 2000 5000 G4 CASSETTE AUTOCLAVE e Operator s Manual SciCan Your Infection Contvol Specialist oo STATIM 2000 5000 G4 Operator s Manual 95 113364 Rev 2 0 Copyright 2014 SciCan Ltd All rights reserved Table of Contents 1 AMIPOGU COT aiiusesctuetrensiterieceniteoniteitenweneniane 3 5 2 Important Information lt s ersresreosenners 4 2 Disclaimers 2 2 STATIM 2000 G4 Unit Overview 2 3 STATIM 5000 G4 Unit Overview 2 4 Touchscreen Overview 2 5 Setup Menu Overview 6 3 Setting Up your STATIM cccsccescesseesseenseneeeeees 10 3 1 Positioning and Powering your Unit 3 2 Leveling your Unit Using your STATIM ccscccesscensecnsecenscenseensseenseees 26 5 1 Preparing Unit for Use 5 2 STATIM 2000 G4 Selecting a Cycle 5 3 STAT IM 5000 G4 Selecting a Cycle 5 4 STATIM 2000 5000 G4 Running a Cycle 5 5 STAT IM 2000 5000 G4 Stopping a Cycle Storing and Retrieving Cycle Information 37 6 1 Retrieving Cycle Information Using the Touchscreen 6 2 Retrieving Cycle Information Using the USB Data Backup 6 3 Cycle Printout Overview 3 3 Connecting the Waste Bottle Retrieving a Remote Access Code 39 a aca I 8 Printing Cycle Information scsssesesesenees 40 3 6 Shipping the Unit 8 1 Connecting to a Printer 3 7 Setting the Time 8 2 Adjusting your Printer Settings 3 8 Setting the Date 8 3 External Printers and Spec
19. T M to a network consult the separate manual titled STAT M 2000 5000 G4 Setting Up and Using Your Web Portal mm dd yyyy hh mm ss SELECT A CYCLE 6 2 Retrieving Cycle Information Using the USB Data Back Up The USB storage device can be used to transfer 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 1 Plug the USB storage device into the USB port 2 The STAT M keeps track of what data has already been transferred to the USB storage device and will automatically load only new data 3 When the activity light on the provided 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 NOTE 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 To view all the cycles stored on the USB storage device you must use your computer Page 37 6 Storing and Retrieving Cycle Information 6 3 Cycle Printout Overview Model STAT M 2000 software S203R604 Unit Identifier autoclave has been set up as number 000 Water Quality conductivity measurements Cycle Counter the number of cycles having been run on the unit 2 Time Date 10 47 am 25th October 2007 Cycle Name UNWRAPPED Cycl
20. TE PRESS STOP TO RESET REMOVE CASSETTE To ensure that wrapped instruments are dry allow the cycle to run to completion If the cassette contains wrapped instruments and the wraps are not dry when the cassette is open the instruments must be handled in an aseptic manner for immediate use or resterilized When the automatic 60 minute drying stage is finished the display reads CYCLE COMPLETE PRESS STOP TO RESET REMOVE CASSETTE By default if the sterilization cycle is successful the reminder tone sounds for 30 seconds or until the STOP button is pressed or the cassette is removed from the unit A Be careful The metal parts will be hot and the cassette will contain hot steam After the cassette is removed from the unit it should be opened to hasten drying of unwrapped instruments Page 35 5 Using your STATIM If the screen displays a CYCLE FAULT code or a NOT STERILE message the cassette contents are not sterile See Section 10 Troubleshooting for more information STOP BUTTON PRESSED NOT STERILE PRESS STOP TO RESET REMOVE CASSETTE 5 5 STATIM 2000 5000 G4 Stopping a Cycle To stop acycle press the STOP button If the STOP button is pushed the cassette is removed or the unit detects a problem while operating the cycle will stop Once a cycle has been stopped the STOP button must be pressed before another cycle can be started The display reads any of the following messages STOP BUTTON PRESSED CYC
21. a network go to the Set up menu and use 4 V to scroll to DST ON OFF and select Use A 2 to toggle DST ON or OFF and press 2 to save and return to the Setup menu 3 8 Setting the Date Xk d WE 2 Scroll to and select 3 From the DATE screen use the keypad to set the date Press en to save and to return to the Setup menu 4 To change your format in which the date appears return to the Setup menu and use 2 to scroll to DATE FORMAT Select it and follow the prompts to have the date displayed in the desired format Press to save and return to the Setup menu 3 9 Setting the Language The messages displayed by your STATIM can be presented in a number of different languages To change the current language follow these steps 2 Scroll to and select 3 From the Language screen press A v to scroll through the list of languages When you have found the desired language press to save your selection and return to the Setup menu Page 14 3 Setting up your STATIM 3 10 Am Unit Identifier Number 2 Scroll to and select 3 Using the keypad select a maximum of 3 digits to be used as the unit s identifier number Press en to save and to return to the Setup menu 3 11 TN a User ID and PIN ES As 2 Scroll to and select 3 From the SETUP PIN screen you can assign up to four PINs Select one of the User icons to assign a PIN 4 Using the keypad assign a PIN of up to four digi
22. ch sterilization cycle microbiologically filtered air drying will commence for 60 minutes by default Air drying can be interrupted at any time Once unwrapped instruments are exposed to ambient or external conditions they cannot be maintained in a Sterile state If sterile storage is desired wrap the instruments to be sterilized in autoclave bags according to the instrument manufacturer s instructions and allow the wrapped cycle to run until the air dry phase is complete The types of instruments sterilization requirements and graphs depicting each cycle are described on the next few pages Consult the Instrument Weight Table in Section 4 6 for information on how to make up an appropriate load for the masses specified for individual cycles 5 3 1 Unwrapped Cycle The Unwrapped Cycle is used to sterilize light STATIM 5000 G4 Bi loads less than 0 5 kg or 1 1 lbs of solid metal instruments such as pliers burrs scalers and forceps To select the Unwrapped Cycle press the Unwrapped Cycle button then press the START button E F Warming up Sterilizing Conditioning Venting Pressurizing Air Drying The sterilization temperature in the cassette is 132 C 270 F and the holding time is 3 5 minutes See Section 4 4 Preparing and Loading Instruments before running this cycle Page 29 5 Using your STATIM 5 3 2 Wrapped Cycle STATIM 5000 G4 The Wrapped Cycle is used to sterilize up to JE 1 5 kg 3 3
23. companied the indicator At the first indication of a potential sterilization failure 1 2 3 Do not process any more instruments until favourable test results have been returned Ensure the correct indicator type was chosen Ensure the cassette was not overloaded Consult the earlier portion of this section for proper loading instructions If the results do not change do not process any more instruments within the STAT M and contact your SciCan dealer for further assistance It is recommended that the tests be conducted so that the incubation period occurs during a period of planned downtime such as the last cycle before a weekend 4 6 Instrument Weight Guide Instrument Typical Instrument Weight Scissors 30 g 0 96 oz Dental scalers 20 g 0 64 oz Forceps 15 g 0 48 oz Dental handpiece 40 to 60 g 1 29 to 1 92 oz Wrapped instrument rack 260 g 8 35 oz Unwrapped instrument rack 225 g 7 23 oz Suction cannula 10 g 0 32 oz Plastic mouth mirror 8 g 0 25 oz Impression tray 15 to 45 g 0 48 to 1 45 oz Plastic x ray positioning ring 20 g 0 64 oz NOTE The above weights are to be used as reference only For exact weights of your instruments consult the manufacturer s specifications Page 25 5 Using your STATIM Before using your STAT M for the first time make sure the reservoir is full and the pump is properly primed Refer to Sections Filling the Reservoi
24. d fit flush with the lid s outer surface Ensure the seal is completely inserted Feel around the periphery to ensure the seal is securely in place NOTE During a cycle steam may appear between the lid and the tray If this persists remove the cassette and check that the seal is correctly installed Figure 13 A Be careful The metal parts will be hot and the cassette may contain hot steam Page 43 9 Maintaining your STATIM 9 7 Maintaining Fluid Levels 1 The water reservoir level is continually monitored by your STAT M If the reservoir is low a red X will appear on the water icon cae of the cycle select screen Press the icon to go to the next screen to confirm that it is a water level issue and not a water quality issue If the reservoir is low a X will appear next to WATER LEVEL To fill the reservoir use only steam processed distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm Remove the cap from the top of the unit and fill the reservoir We recommend using a funnel to minimize spills Each time you refill the reservoir empty the waste bottle and refill with water to the MIN line Empty the waste bottle often to avoid unpleasant odors and discoloration of the contents A low level chlorine free disinfectant prepared according to the manufacturer s instructions may be added to the waste bottle to remedy this situation 9 8 Reading Water Quality 1
25. d select 3 From here you can either select for a menu of preloaded themes or to access a new theme that can be loaded using the USB port 4 Inthe screen 4 2 use to scroll through your available options As you scroll each theme will display on the touchscreen Press A to select your theme and return to the Setup menu 5 To upgrade a theme available from SciCan download the theme onto your computer s desktop and save the files onto a portable USB storage device Insert the device into your STAT M s USB port and from the UPGRADE THEME screen press 5 1 The unit will load the files directly from the USB storage device Do not remove the USB storage device while files are loading this could take as long as 10 minutes When it is complete the screen will display the Done message This new theme will now be accessible from your THEMES menu 5 2 Press to select this theme and return to the Setup screen 3 14 Adjusting the Screensaver Delay To change the length of time before your inactive touchscreen activates the screensaver follow these steps 2 Scroll to and select 3 Use A 2 to scroll through you time options When you have found the amount of time you require press it Press to save and return to the Setup menu 3 15 Adjusting the Screen Contrast The STAT IM G4 touchscreens are calibrated for the lighting condition of most sterilization centres Should you need to adjust the contrast for your offic
26. e follow these steps 1 D a pa 2 Scroll to and select 3 Use A s to scroll through your contrast options When you have found the contrast you require press it Press to save and return to the Setup menu Page 16 3 Setting up your STATIM 3 16 Turning the Button Sound ON or OFF The STATIM G4 is preset to beep when a button is pressed If you would like to turn the button sound off follow these steps 3 Use A 2 to scroll through your ON or OFF options and select it by pressing it Press to save and move back to the Setup menu 3 17 Adjusting the Button Beep Volume If you would like to adjust the beep volume follow these steps 2 Scrollto Beep Volume and select 3 Use 4 2 to scroll through the volume settings Select the one you want by pressing it Press to save and move back to the Setup menu 3 18 Setting up and Using your STATIM G4 Web Portal The STAT M G4 web portal is a direct connection to the STAT M on your local area network It is protected by your firewall and not accessible to outside users unless they have a Remote Access Code For more information see Section 7 Retrieving a Remote Access Code The web portal provides real time cycle information and archived sterilization records unique to this unit From here you can print reports set up email notification and search cycle histories To set up your web portal follow the instructions available on the portal s HELP tab
27. e Name cont d parameters 135 C 3 5 min Cycle Clock starting at 0 00 Warm up complete start of the conditioning phase is 1 19 See cycle graph A phase complete start of B phase Start Time of Pressurization 1 27 start of C phase Start Time of Sterilization 2 27 start of D phase Temp Press amp Time at start of sterilization D phase Temp Press amp Time printed at 30 second intervals during sterilization D phase Temp Press amp Time of end of sterilization phase end of D phase Time Venting started 5 57 start of E phase Time Air Drying started 6 42 start of F phase Cycle completion time 22 42 Page 38 STATIM 2000 UNIT WATER QUALITY CYCLE NUMBER 10 47 UNWRAPPED 135 C FOR 3 5 MIN CYCLE START CONDITIONING PRESSURIZING STERILIZING 136 4 C 220KPA 136 0 C 219KPA 135 9 C 222KPA 136 1 C 222KPA 136 5 C 225KPA 136 4 C 225KPA 136 1 C 221KPA 136 1 C 221KPA VENTING AIR DRYING CYCLE COMPLETE S203R604 000 0 5 uS 0 3 ppm 000002 10 25 2007 0 00 1 27 2 27 221 Ble yf 3 27 3 57 4 27 4 57 DZ DO 5 57 6 42 22 42 7 Retrieving a Remote Access Code To allow access to external persons to gain remote access to the STAT M G4 you will need to provide a security token to the person requesting access To obtain this code follow these steps 2 Scroll to and select 3 P
28. ever install and operate the unit on a sloped surface e Electromagnetic Environment Your STATIM has been tested and meets applicable standards for electromagnetic emissions While the unit does not emit any radiation it may itself be affected by other equipment which does We recommend that your unit be kept away from potential sources of interference e Electrical Requirements TO power your unit use properly grounded and fused power sources with the same voltage rating as indicated on the label at the back of your STAT M Avoid multiple outlet receptacles If using a surge Suppressor power bar connect only one STAT M to it Powering your Unit To power your STATIM connect the power cord to the A C inlet receptacle at the back of the unit Ensure the power switch is in the OFF position and connect the unit to your power source Page 10 3 Setting up your STATIM 3 2 Leveling your Unit When placing your unit on a counter top ensure it is stable and that all four feet are securely in contact with the counter surface This will prevent the unit from moving freely Next use the level indicator bubble function in the settings menu to adjust the three leveler feet so that the unit drains properly To access the level indicator bubble from the main screen follow these steps wt ae tg 2 Scroll to and select 3 Adjust the leveler feet to move the bubble Position the bubble in the bottom right quadrant of the target This wil
29. foam air filter FA 3 Install the new filter SciCan part no 01 1002075 4 Secure the filter plate to the back of the compressor using the screw 5 retained during the disassembly procedure To change the air filter on the STAT M 5000 G4 follow these steps 1 Unscrew the cylindrical air filter 3 in a counter clockwise direction 2 Discard the old filter 3 Screw the new filter SciCan part no 01 101652S finger tight only into place Page 42 9 Maintaining your STATIM 9 6 Replacing the Cassette Seal To ensure optimum performance of your STAT M cassette autoclave change the cassette seal every 500 cycles or every six months whichever comes first Replacement seals are available from SciCan order number 01 100028S for STATIM 2000 G4 and 01 101649S for STATIM 5000 G4 To change the cassette seal follow these steps Place the cassette lid and the new seal on a clean work surface Examine the position of the old seal in the cassette lid and arrange the new seal in the same orientation next to the lid 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 Align the holes in the new seal with the holes in the lid NOTE At every corner and at the holes in the lid two square nibs should be visible The nibs shoul
30. have been cleared by the FDA for use with the respective cycle time and temperature of the STAT M 2000 5000 G4 Cassette Autoclaves must be used Note for Ophthalmology Use In the field of ophthalmology proper wrapping or pouching of surgical instruments will reduce the exposure of instruments to any process residues during the sterilization cycle Due to the highly sensitive nature of some types of surgery particularly in ophthalmology SciCan recommends that all instruments be routinely packaged or wrapped and processed through the wrapped cycle of the sterilizer This practice is the suggested approach for the majority of sterile surgical procedures and is referenced in most leading infection control publications and guidelines Page 24 Using Cassettes and Preparing Instruments 4 5 Using Biological and Chemical Indicators For detailed instructions on how to handle use and dispose of both the biological and chemical indicators please consult the product literature accompanying the indicators or contact the manufacturer directly To use the indicators with the STAT M follow these steps 1 2 Place the appropriate biological indicator in the STATIM chamber Process the load in the sterilizer according to your usual practice Ensure that the message Cycle Complete is displayed on the LCD after the cycle is finished Recover the biological and or chemical indicator and process further according to the literature that ac
31. he underside of the unit Push the excess length of tubing back into the space provided Figure 5 Figure 6 Make sure the plug in the drain tube is secured After installation and before sterilizing any instruments run two Wrapped cycles For further instructions see Section 5 1 Preparing the Unit for Use 3 6 Shipping the Unit Before you move the unit you will need to drain the reservoir To do so follow these steps 1 Place a water container below the unit 2 Using the drain tube see Section 3 5 Priming the Pump Figure 6 empty the contents of the reservoir into the water container 3 Remove any remaining water from the reservoir with a non linting absorbent towel Screw in the three leveler feet found underneath the unit 5 Repack the unit in the original packing materials and include all accessories originally included with the unit 6 Specify heated and insured shipping Page 13 3 Setting up your STATIM 3 Setting the Time 2 Scroll to and select 3 From the TIME screen use the keypad to set the time Press en to save and to return to the Setup menu 4 To change your unit to display 12 hour time format 24 hour time format is the default setting go to the Setup menu and use 4 V to scroll to TIME 12 24 select it and toggle to 12 Press to save and return to the Setup menu 5 To activate daylight savings time DST which is recommended if you have connected your unit to
32. ht Casette Size Internal Length Width Height Extended Section Internal Length Width Height Sterilization Chamber Volume Extended Sterilization Chamber Volume Reservoir Volume Weight Without water Clearance required Top Sides Back Front Maximum Steam Temperature Maximum Operating Pressure Electrical Rating 10 600 mm 23 6 414 mm 16 3 190 mm 7 5 495 mm 19 5 includes handles 195 mm 7 7 80 mm 3 2 565 mm 22 2 includes handles 195 mm 7 7 80 mm 3 2 380 mm 15 180 mm 7 1 75 mm 3 110 mm 4 3 130 mm 5 1 28 mm 1 1 5 1 L 170 fl oz U S 5 5 L 186 fl oz U S 4 0 L 140 fl oz U S 33 kg 73 Ibs 50 mm 1 9 50 mm 1 9 50 mm 1 9 570 mm 22 4 138 C 280 F 341kP abs 49 5 psia 100 V 50 60 Hz 11A 110 V 50 60 Hz 11A 220 240 V 50 60 Hz 6 A see serial number label for requirements specific to your unit Ethernet Port USB Port Protection Class Protection Ambient Operating Temperature and Humidity Max Altitude Installation Category Page 53 10 100 Base T USB 2 0 covered indoor use only 15 C to 25 C 59 F to 77 F and 25 to 70 Up to 2000 meters 6600 ft 1
33. ifications 3 9 Setting the Language a 3 10 Assigning Unit Identifier Number 9 Maintaining your STATIK c cccssssesseessenseeeees 41 3 11 Creating a User ID and PIN 9 1 Cleaning the Cassette 3 12 Setting Up Process Enforced Usage 9 2 Cleaning the Water Reservoir Filter 3 13 Changing the Touchscreen Display Themes 9 3 Cleaning the Reservoir 3 14 Adjusting the Screensaver Delay 9 4 Cleaning the Exterior Surfaces 3 15 Adjusting the Screen Contrast 9 5 Changing the Bacteria Retentive Filter and the Air Filter 3 16 Turning the Button Sound ON or OFF 9 6 Replacing the Cassette Seal 3 17 Adjusting the Button Beep Volume 9 7 Maintaining Fluid Levels 3 18 Setting up and Using your STAT M G4 Web Portal 9 8 Reading Water Quality 3 19 Connecting to a Network 9 9 Using On Screen Instructions 3 20 Connecting to a Wireless Network 9 10 Preventative Maintenance Schedules 3 21 Reserving an IP Address for your STATIM 10 Troubleshooting your STATIM c scceseeeseeees 47 4 Using Cassettes and Preparing Instruments 20 11 Spar Paris eee cccatse sets iden seasccsnccccicencedeecstuavdenstsneaxs 50 4 1 Using the STATIM 2000 G4 Cassette 4 2 Using the STATIM 5000 G4 Cassette s MV APU ANIC eeicsientsnaivats uaseanynneh EAA 51 4 3 Using Drying Plates with the STATIM 5000 G4 13 Specifications cssecesssesseessseeeseesesesseseeeees 52 4 4 Preparing and Loading Instruments 4 5 Using Biological and Chemical Indicators 4 6 Instrument Weight Guide
34. l be hot and the cassette will contain hot steam Inspect the cassette to ensure that the holes in the back of the seal are perfectly aligned and that the flexible lip of the seal is completely free Check the exhaust tube for kinks or obstructions If kinked straighten the tube If the tube cannot be straightened remove it from the push in fitting attached to the STAT M 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 Be sure that you leave enough tube to reach the unit when you re attach the tube to the exhaust fitting If the tube is too short to remove a section contact your SciCan dealer for a replacement Check that the STAT M has not inadvertently been exposed to any electrical interference Refer to Section 3 1 Positioning and Powering your Unit Try running another cycle Ifthe problem persists record the cycle fault message number and contact your dealer Excessive steam issuing from the front of the machine Remove and reinsert the cassette Attempt another 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 If the leak persists turn the unit OFF remove and unload the cassette and contact your SciCan dealer Machine will not start and touchsc
35. l ensure that the unit drains properly Press STOP to exit and return to the cycle select menu When the unit is properly leveled the bubble level will change from red to green S Ge mv Page 11 3 Setting up your STATIM 3 3 Connecting the Waste Bottle The waste bottle ff 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 1 Insert the exhaust tube 27 into the fitting on the back of the unit and pull gently to E confirm a tight fit 2 Cut the tube to length and slide the waste bottle fitting F into place 3 Place the free end of the tube into the hole in the lid of the waste bottle and hand tighten the fitting Do not coil the exhaust tube 4 Unscrew the lid and copper condenser coil 5 assembly from the waste bottle The lid and coil should come out together o Fill the waste bottle with water to the MIN line and replace the lid and copper condenser assembly Empty the waste bottle often to avoid unpleasant odors and discoloration of the contents A low level disinfectant prepared according to the manufacturer s instructions may be added to the waste bottle to remedy this situation As a minimum empty the waste bottle each time you refill the reservoir Place the waste bottle near the unit Store the bottle below the unit The tube can be routed through a hole 8 mm 0
36. le 9 4 Cleaning the Exterior Surfaces Use a soft cloth moistened with soap and water to clean all exterior surfaces Do not use harsh cleaning chemicals or disinfectants Page 41 9 Maintaining your STATIM 9 5 Changing the Bacteria Retentive Filter and the Air Filter 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 STAT M 2000 G4 and 5000 G4 follow these steps 1 Power the STATIM OFF 2000 G4 2 Disconnect tube A ff from the bacteria retentive filter PA and remove the filter from the filter bracket S As you remove the filter from the bracket note the orientation of the arrow mark on the filter 3 When the filter is free of the bracket carefully disconnect tube B El from the filter 4 Before installing the replacement bacteria retentive filter SciCan order no 01 102119S check that the arrow mark on the filter matches the direction of the arrow on the bracket Push the left hand filter fitting into tube B G7 5 Gently press the replacement filter into the filter bracket j The arrow mark of the filter should be facing out and pointing to the left 6 Re connect tube A 57 to the right hand filter fitting To change the air filter on the STAT M 2000 G4 follow 5000 G4 E these steps 1 Turn the power switch at the back of the unit OFF 2 Remove and discard the old
37. m sterilization The STAT M has not been designed to sterilize liquids cloth loads bio medical waste or materials not compatible with steam sterilization The processing of such loads may result in incomplete sterilization and or damage to the autoclave For more information about instrument suitability for steam sterilization consult the instrument manufacturers reprocessing instructions Page 3 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 SciCan shall not be liable for incidental special or consequential damages caused by any maintenance or services performed on the STAT M by a third party or for the use of equipment or parts manufactured by a third party including lost profits any commercial loss economic loss or loss arising from personal injury Never remove the cover of the unit and never insert objects through holes or openings in the cabinetry Doing so may damage the unit and or pose a hazard to the operator All elements of this book are common to both STAT M 2000 G4 and STAT M 5000 G4 except when noted IMPORTANT Follow local guidelines governing verification of the sterilization procedure Drying Performance The STATIM 2000 G4 and 5000 G4 have been designed to p
38. n be sterilized in this cycle Using the STATIM 5000 Extended Cassette order no 01 112509S will allow for the sterilization of rigid endoscopes in this cycle E F Warming up Sterilizing Conditioning Venting Presurizing Air Drying HEAVY DUTY UNWRAPPED HEAVY DUTY UNWRAPPED Press START Press START To select the Heavy Duty Unwrapped Cycle press the Heavy Duty Unwrapped Cycle button then press the START button The sterilization temperature in the cassette is 132 C 270 F and the holding time is 6 minutes Page 31 5 Using your STATIM 5 4 STATIM 2000 5000 G4 Running a Cycle To operate each cycle follow these steps 1 Turn the power switch at the back of the unit to ON At start up the unit will display the main menu mm dd yyyy hh mm ss SELECT A CYCLE 2 Press the appropriate cycle button on the touchscreen The display will show the cycle name and parameters 3 Press the START icon NOTE If Process Enforced usage is enabled a PIN screen will appear after you have pressed START Enter your PIN to start the cycle Enter PIN i alls iie Page 32 5 Using your STATIM If the unit is not properly levelled a warning screen is displayed advising to level the unit to attain optimal instrument dryness Once the bubble level indicates a proper level press Continue to start the cycle Please level your unit to attain optimal instrument dryness
39. on disappears When the Network icon is active for example when sending email it will turn green NOTE Use QR code if connecting to a mobile device NOTE Connection time will vary depending on your network speed and making an initial connection can take longer 3 20 Connecting to a Wireless Network The STAT IM G4 can be configured for wireless use by connecting the Ethernet port to an external wireless bridge access point SciCan currently recommends the use of the D Link DAP 1522 Xtreme N Duo Wireless Bridge Contact your network administrator to learn more about setting up a wireless bridge Page 18 3 Setting up your STATIM 3 21 Reserving an IP Address for your STATIM When your STAT M is connected to a router on your network it is assigned a unique IP address If the connection between your STAT M and the router is lost e g power failure STAT M or router was restarted the re established connection may be a different IP address This may cause any previously saved bookmarks or other saved links to become invalid To set a permanent IP address also Known as establishing a DHCP IP Address Reservation follow these steps 1 Select the Network icon From the STAT M G4 touchscreen and write down the numbers found for the GATE Router Local IP Enter this GATE number in the address bar of your web browser to access your router settings NOTE You will need your network password to change the settings
40. one with drying plates affixed and another without To ensure optimal drying of instruments within autoclave bags use the rack with drying plates 4 4 Preparing and Loading Instruments Before loading any instruments into the STAT M consult the manufacturer s reprocessing instructions Clean Instruments Clean and rinse all instruments before loading them into the cassette Disinfectant residues and solid debris may inhibit sterilization and damage the instruments the cassette and the STAT M Lubricated instruments must be wiped thoroughly and any excess lubricant should be removed before loading Unwrapped Instruments Arrange unwrapped instruments on the rack in the tray so that they do not touch one another This ensures that steam reaches all surfaces and will promote drying Page 22 4 Using Cassettes and Preparing Instruments Wrapped Instruments single wraps Place the instruments into single layer autoclave bags according to the manufacturer s instructions UI Orient the instrument rack in the cassette to ensure that wrapped instruments rest approximately 6 mm 0 25 above the cassette base Place the wrapped instruments on the rack and arrange them to avoid overlap Ensure that all wrapped loads are dry before handling and or storage to maintain sterility The use of cloth wraps in the STAT M is not recommended SciCan recommends the use of paper paper and plastic paper autoclave
41. oning properly e Check the LAN cable try a new cable if possible e Make sure your router assigns IP addresses automatically Renew the IP address by following these steps 1 Scroll through the setup menu to NETWORK SETUP and select 2 Select RENEW IP Unit is not sending emails Check email settings by using the TEST button on the unit s web portal From the SETUP web page select the TOOLS tab Click on TEST to check your router unit and Internet connections If all settings appear to be OK Go to the unit s touchscreen and renew the IP address by following these steps 1 Scroll through the setup menu to NETWORK SETUP and select 2 Select RENEW IP Not receiving emails from the unit Check your spam filter Be certain the unit has been identified as an accepted email source Page 49 11 Spare Parts Page 50 STATIM G4 SPARES h STATIM G4 ACCESSORIES 01 100028S Cassette Seal 2000 01 112406S Cassette Complete 2000 G4 01 112409S Cassette Lid 2000 G4 01 112408S Cassette Tray 2000 G4 01 112410S Cassette Handle Lid 2000 G4 Cassette Tray with Mesh Rack 01 112407S 2000 G4 01 103945S Rack tray Unwrapped Instr Kit 2000 01 106653 Mesh Rack STATIM 2000 01 101649S Cassette Seal 5000 01 112384S Cassette Complete 5000 G4 01 112386S Cassette Lid 5000 G4
42. ove a section contact your SciCan dealer for a replacement Make sure the compressor is working To check remove the exhaust tube from the waste bottle Start the Air Drying Only Cycle and place the free end into a glass of water If there is not a strong steady flow of bubbles the compressor is not functioning properly Contact your SciCan dealer Page 48 10 Troubleshooting your STATIM Problem Solution Time and date are incorrect The time and date have not been set See Section 3 Setting up your STATIM for time and date instructions Touchscreen is blank white Power was interrupted during a firmware upgrade Power off the unit and power it on again It can take up to 6 minutes before the main menu screen appears Touchscreen is blank dark Check power source USB storage device does not contain the last print out Re insert the USB storage device and wait for the data to copy over again If problem persists back up all the information you have on the USB device and reformat it NOTE You can always access all your unit s cycle information through the unit s web portal Touchscreen shows An X over the connectivity icon means the unit is not connected to a network If it is supposed to be connected to a network and the X is visible it is because the unit is unable to acquire an IP address To resolve the issue try some of the following e Check that the router is functi
43. r and Priming the Pump for detailed instructions 5 1 Preparing Unit for Use Once the unit is installed and before any instruments are sterilized run two Wrapped Cycles see Section STATIM 2000 5000 G4 Running a Cycle Remove the cassette once it has cooled Clean the top lid and bottom tray sections using a soft cloth to wipe the inside surfaces and then rinse thoroughly with tap water 5 2 STATIM 2000 G4 Selecting a Cycle The STATIM 2000 G4 has three sterilization cycles each designed to sterilize a specific type of instrument The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave At the end of each sterilization cycle microbiologically filtered air drying will commence for 60 minutes by default Air drying can be interrupted at any time Unwrapped instruments once exposed to ambient or external conditions cannot be maintained in a Sterile state If sterile storage is desired wrap the instruments to be sterilized in autoclave bags according to the instrument manufacturer s instructions and allow the wrapped cycle to run until the air dry phase is complete The types of instruments sterilization requirements and a graph depicting each cycle are described over the next few pages Consult the Instrument Weight Guide for information on how to make up an appropriate load for the masses specified for individual cycles 5 2 1 Unwrapped Cycle STATIM 2000 G4 The Un
44. reen shows Press on the icon to confirm whether it is a water level problem or a water quality problem If it is a water quality problem you have likely used water which is not steam process distilled or is improperly distilled Empty the reservoir and refill with steam process distilled water containing less than 5 ppm total dissolved solids having conductivity of less than 10 uS cm If you have the water conductivity meter check the quality of the water before refilling the reservoir To empty the reservoir see Section 3 6 Shipping the Unit If the level of the water in the reservoir is low refill the reservoir Refer to the steps described in Section 3 4 Filling the Water Reservoir The printer does not work Make sure that the printer cable is connected securely with the connector on the back of the STAT M Make sure that the printer is powered ON Power unit OFF for 10 seconds and then power ON again Page 47 10 Troubleshooting your STATIM Problem Solution Unit does not power ON There is water under the machine A A 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 Try another circuit Power unit OFF for 10 seconds and then power ON again Check the condition of the line circuit breaker or fuse Check that water was not spilled when refilling the reservoir Make sure the plug in the exhaust
45. ress and wait a few seconds for a security token to be provided Once displayed provide the token to the person requiring Remote Access NOTE This token will be valid for only 2 hours at which time the remote session will automatically disconnect Should you wish to end the session earlier select from the same menu to disable the token Page 39 8 Printing Cycle Information The STATIM G4 is equipped with an RS232 serial port to allow you to connect it to an external printer For a list of recommended printers see the table below 8 1 Connecting to a Printer To connect the printer follow these steps 1 Connect the external printer to the STATIM G4 s RS232 port using the serial printer cable supplied with your printer 2 Power on the printer 3 On the STATIM G4 select ass 4 Scrollto Printer Type and select 5 Use 2 to toggle to the Serial Printer option and select Press to save and move back to the Setup menu 8 2 Adjusting your Printer Settings The STAT M G4 allows for several printer adjustments You can access these settings from the user setup menu see instructions above Use the table below or your printer s operator manual to make the correct adjustments to your printer S BaudRate ae End of Line End of Line CR LF and Printer User Printer User Char 8 3 External Printers and Specifications Suggested External End of Line CR LF Serial Port Bitrate Printer user char Printers b
46. rovide a complete sterilization solution for your unwrapped and wrapped instrument needs Rapid sterilization balanced with rapid drying through the use of SciCan s Dri Tec Drying Technology To dry instruments the STAT M 2000 G4 uses a combination of forced filtered air and convection heat The convection heat is derived from utilizing the remaining heat in the system after the sterilization phase has been completed The heat is then captured and released into the cassette to rapidly dry a properly loaded cassette The STAT M 5000 G4 also uses forced filtered air and heat generated by the sterilization phase to dry the instruments The heat generated by the sterilization phase is absorbed by the drying plates and then transferred directly to the load This then results in the accelerated rapid drying of a properly loaded STATIM cassette Please refer to Section 4 4 Preparing and Loading Instruments for instructions on the proper arrangement of instruments in the cassette and the use of Drying plates STAT M 5000 G4 By carefully following these directions on how to properly load the cassette chamber rapid drying of the load will be achieved Page 4 2 Important Information 2 2 STATIM 2000 G4 Unit Overview LCD Touchscreen Reservoir cap water filter USB port Power switch Power cable port A Leveler feet Ethernet port B Exhaust tube port E Compressor Cassette Biological filter RS232 port The following symbols appear f
47. s completed before the period of non use After the period of non use and before any instruments are sterilized run three wrapped cycles Remove the cassette once it has cooled Clean the top lid and bottom tray sections using a soft cloth to wipe the inside surfaces and then rinse thoroughly with tap water Page 45 9 Maintaining your STATIM Technician Once a year Cassette Check the tray lid and seal for damage Replace if necessary Biological Filter Inspect the biological filter for moisture Solenoid Valve Inspect the valve and clean if dirty Replace the plunger if defective Pump Clean the filters replace if dirty Remove the exhaust tube from the back of the unit during the air drying phase Check for air coming from the fitting Check Valve Remove the air compressor tube from the check valve inlet while running a cycle Make sure no steam is leaking from the valve Replace if there are any leaks Water Reservoir Calibration Check the reservoir for dirt Clean and rinse with steam process distilled water if necessary Calibrate the unit Page 46 10 Troubleshooting your STATIM Problem Solution Unit displays Cycle interrupted NOT STERILE Cycle aborted NOT STERILE or CYCLE FAULT messages Wait a few minutes and attempt another cycle before proceeding to the next solution Remove the cassette Be careful The metal parts wil
48. s being used and maintained according to the description in the user s manual In the event of failure due to such defects during this period of time the exclusive remedies shall be repair or replacement at SciCan s option and without charge of any defected part s except gasket provided SciCan is notified in writing within thirty 80 days of the date of such a failure and further provided that the defective part s are returned to SciCan prepaid This warranty shall be considered to be validated if the product is accompanied by the original purchase invoice from the authorized SciCan dealer and such invoice identifies the item by serial number and clearly states the date of purchase No other validation is acceptable After one year all SciCan s warranties and other duties with respect to the quality of the product shall be conclusively presumed to have been satisfied all liability therefore shall terminate and no action or breach of any such warranty or duty may thereafter be commenced against SciCan Any express warranty not provided hereon and any implied warranty or representation as to performance and any remedy for breach of contract which but for this provision might arise by implication operation of law custom of trade or course of dealing including any implied warranty of merchantability or of fitness for particular purpose with respect to all and any products manufactured by SciCan is excluded and disclaimed by SciCan
49. ting the Cassette into the STATIM 2000 G4 1 Place the end of the cassette into the unit 2 Gently push inward until you hear a click sound and check the LCD icon for change from E to 1H Never force the cassette into the STAT M as the interior components could be damaged NOTE The main menu screen will display v if the cassette is not properly inserted in the unit Removing the Cassette 1 Grasp the handle with two hands and pull away from the unit 2 Pull the cassette clear of the unit and set down on a firm surface e Disengaging the Cassette When not in use the cassette should be disengaged To disengage the cassette grasp the handle and pull the cassette out until there is a 15 mm to 20 mm to gap between the front of the STAT M 2000 G4 and the cassette handle Page 20 4 Using Cassettes and Preparing Instruments 4 2 Using the STAT IM 5000 G4 Cassette When removing the cassette after a cycle exercise caution as the metal areas will be hot and the cassette may contain hot steam Opening the Cassette 1 Push the carry handle into the open position 2 Put your hands on either side of the cassette handle Si 3 Insert your forefingers in the slots and place your thumbs on the thumb pads 4 Press down with your thumbs and pull up with your forefingers until the lid opens 5 Raise the cassette lid and disengage from the tray Rest the lid on its outer surface Closing the Cassette
50. ts and press en to save and to move to the confirmation screen Setup PIN PIN Setup gt User x ooo PN a Seis ne 208 Z 5 If all of the information presented in the confirmation screen is correct press OK to be returned to the PIN USER screen To make a correction select the PIN User you want to change and repeat the process described above 3 12 Setting Up Process Enforced Usage When process enforced usage is activated users are required to enter a PIN both at the beginning and at the end of a cycle For Process Enforced usage to function User IDs and PINs must first be assigned To set up User ID and PINs refer to Section Creating a User ID and PIN To activate Process Enforced usage follow these steps 2 Scroll to Process Enforced and select 3 Use A 2 to toggle Process Enforced function ON or OFF Press to save your selection and return to the Setup menu NOTE Any user can stop a cycle and remove the cassette even with Process Enforced usage ON However the cycle data will record that an unauthorized user has stopped the cycle and or removed the cassette Page 15 3 Setting up your STATIM 3 13 Changing the Touchscreen Display Themes Your STATIM G4 touchscreen themes i e the colours of the icons and background can be changed to one of the preset options or you can upload additional themes as they become available from SciCan change themes follow these steps 2 Scroll to an
51. unsure of your E instrument s material or construction do not load into your STAT M until you have checked with the instrument manufacturer All Instruments The STAT M 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 If sterile storage is desired wrap the instruments to be sterilized in autoclave bags according to the instrument manufacturer s instructions and then allow the wrapped cycle to run until the air dry phase is complete Best Practice Allow instruments wrapped or unwrapped to dry completely prior to handling Wrapped or pouched instruments must not touch each other to promote drying and enable effective sterilization SciCan recommends the final user carefully choose the most appropriate sterilization cycle according to the recommendations of their leading infection control authorities and local regulatory guidelines recommendations Routine Monitoring Chemical process indicators suitable for steam sterilizers should be included in or on each package or load being sterilized In addition the weekly use of biological indicators which allow you to ascertain whether the instruments have been exposed to sterilization condition is recommended Chemical and biological indicators that
52. use drain after each working day leave empty and refill at the start of the next workday Waste Bottle Empty the waste bottle every time you refill the reservoir Fill with tap water up to MIN line marking You may also add some chlorine free disinfectant Unit Cassette Biological and or Air Filter To ensure optimal performance of the STAT M autoclave SciCan recommends that a full sterilization cycle which must include the full Air Drying phase be completed at the end of each day of use This is especially important when the unit is left idle over the weekend or for any extended period of time Wash the interior of the cassette with dishwashing soap or a mild detergent that does not contain chlorine Scrub the inside with a cleaning pad designed for use with Teflon coated surfaces Check the filter for dirt and moisture Replace if dirty Call for service if wet Water Filter Check the water reservoir filter every week and clean if necessary Replace only if necessary Every 6 months Cassette Seal Replace every 500 cycles or six months whichever comes first or whenever necessary Biological and or Air Filter Replace every 500 cycles or six months whichever comes first Extended Period of NON USE Unit If the STAT M is not going to be in use for a week or more ensure that a full sterilization cycle which must include the full air drying phase i
53. ved from the autoclave it may NOT be reinserted for the Air Dry Only cycle If the cassette contains wrapped instruments and the wraps are not dry when the cassette is opened the instruments must be handled in an aseptic manner for immediate use or resterilized To start press the Air Dry Only cycle button then press the START button User will be prompted to confirm cycle selection AIR DRYING ONLY AIR DRYING ONLY Press START Press START When started independently this cycle will run for 1 hour NOTE Sterilized instruments should only be handled once they are dry Drying times can vary depending on the weight of load If best practices are exercised refer to Sections Preparing and Loading Instruments and Maintenance and the load is less than the maximum capacity instruments may be dry in less than 60 minutes Page 28 5 Using your STATIM Before using your STAT M for the first time make sure the reservoir is full and the pump is properly primed Refer to Sections Filling the Reservoir and Priming the Pump for detailed instructions 5 3 STATIM 5000 G4 Selecting a Cycle The STATIM 5000 G4 has four sterilization cycles each designed to sterilize a specific type of instrument It is important not to overload the chamber as this can inhibit steam access to all instrument surfaces The instruments will remain sterile after a successful cycle until the cassette is removed from the autoclave housing At the end of ea
54. wrapped Cycle is a general purpose sterilization cycle used to sterilize up to 1 0 kg 2 2 lbs of solid metal instruments such as pliers burrs scalers and forceps Dental handpieces may be sterilized in this cycle To select the Unwrapped Cycle press the Unwrapped Cycle button then press the START button F Warming up Sterilizing Conditioning Venting sav Pressurizing Air Drying Press START The sterilization temperature in the cassette is 134 C 273 F and the holding time is 3 5 minutes See Section 4 4 Preparing and Loading Instruments before running this cycle Page 26 5 Using your STATIM 5 2 2 Wrapped Cycle STATIM 2000 G4 The Wrapped Cycle is used to sterilize up to 1 0 kg 2 2 Ibs of solid and hollow metal instruments em which have been sealed in paper paper or paper plastic autoclave bags Dental handpieces may be sterilized in this cycle To select the Wrapped Cycle press the Wrapped Cycle button then press the START button Warming up Sterilizing Conditioning Venting Pressurizing Air Drying The sterilization temperature in the cassette is 134 C 273 F and the holding time is 10 minutes See Section 4 4 Preparing and Loading Instruments before running this cycle If wrapped instruments are intended for storage the wraps must be dry when the cassette is removed from the unit and opened m 5 2 3 Rubber and Plastics Cycle STATIM
55. y SciCan Epson TM U220D C31C515603 s n ow ere i Citizen Star Micro Star Micro SP216FD41 120 BRET ki k Star Micro CR LF 9600 210 Oxd2 SP512MD42 R Page 40 9 Maintaining your STATIM 9 1 Cleaning the Cassette Keeping the STAT M 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 coated surfaces After scouring rinse thoroughly with water to remove all traces of the detergent Cleaning the inside of your cassette is very important if you regularly sterilize lubricated instruments 9 2 Cleaning the Water Reservoir Filter The water reservoir filter should be cleaned at least once a week or when required The filter can easily be removed and cleaned by placing the filter upside down under running water to wash away the particles until clean and then placed back into the reservoir opening If a replacement water reservoir filter is required order part number 01 109300S 9 3 Cleaning the Reservoir particles rinse with steam process distilled water ONLY and drain it again Do not use chemicals or cleaning agents as these can cause damage to the unit E Check the inside of the reservoir for dirt or particles To clean the reservoir drain it remove any visib
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