CertoClav STE-45-T, Instruction Manual

Page 1: ...CERTOCLAV Sterilizer GmbH Peintner Straße 10 A 4060 Leonding Austria Instruction Manual CertoClav Vacuum Pro 45 Steam Steriliser Model STE 45 T ...

Page 2: ...ual carefully The long lasting functionality and value retention of your autoclave depend primarily on the maintenance of the device Instruction Manual CertoClav Vacuum Pro 45 CertoClav Valid for model STE 45 T Issue 1 June 2019 Responsible for content CERTOCLAV Sterilizer GmbH Peintner Straße 10 A 4060 Leonding Austria Email support certoclav com www certoclav com 2019 CertoClav Last change 11 06...

Page 3: ...e autoclave 13 6 2 Unlocking the autoclave door 14 6 3 Touchscreen assembly 14 6 4 Installing accessories 16 6 4 1 Connecting the protocol printer 16 6 4 2 Connecting the barcode reader 16 6 4 3 Connecting the label printer 16 6 4 4 Connecting the CertoServer 17 6 5 Pressure sensor calibration 17 6 6 Validation and calibration 18 7 Sterilisation Programs 19 7 1 Default settings 19 7 2 Editing prog...

Page 4: ... the Autoclave 32 10 1 Login Menu 32 10 2 Support Menu 34 10 2 1 Tutorial videos 34 10 2 2 Send email to CertoSupport 35 10 2 3 TeamViewer remote support and share screen 36 10 3 Protocols Menu 38 10 3 1 Viewing protocols 38 10 3 2 Printing protocols 38 10 3 3 Example of a protocol printout 39 10 3 4 Print barcode 39 10 3 5 Tracing marked products 40 11 Settings 41 11 1 User administration 41 11 2...

Page 5: ...g the default settings 53 11 4 6 Changing the language 54 11 5 Configuration of SMS and email notifications 54 11 6 Sensor calibration 55 11 7 GLP and GMP data 55 11 7 1 Header 55 11 7 2 Autoclave designation 55 11 7 3 Project designation 55 11 7 4 Advanced GLP and GMP settings 56 11 8 Locking settings 56 12 Error Messages 57 13 Maintenance 59 14 Transport and Storage 60 14 1 Preparations 60 14 2 ...

Page 6: ...wabs glasses petri dishes porous materials powder hollow bodies and instruments Containers sealed with compressed air must not be sterilised This autoclave has not been developed for private use Operation and maintenance of the autoclave may only be performed by trained personnel Comply consistently with all safety regulations in this instruction manual 1 2 Environmental protection The packaging m...

Page 7: ...ety of the device You can obtain spare parts and accessories from your dealer or from the manufacturer 1 5 Guarantee The guarantee is valid for 2 years The claim to free service shall be nullified if one of the following conditions is not met The damage has been caused by incorrect installation The damage has been caused by negligent conduct The damage has been caused by improper operation The dam...

Page 8: ... CertoClav Vacuum Pro 45 l Model STE 45 T 8 2 Meaning of the Symbols on the Autoclave ATTENTION PROTECTIVE EARTH CONNECTION HOT SURFACE KEEP AWAY MANUFACTURER COMMUNAUTÉ EUROPÉENNE SERIAL NUMBER ENVIRONMENTAL PROTECTION ...

Page 9: ...peration disconnect the autoclave immediately from the power supply and contact your dealer or the manufacturer by email to support certoclav com WARNING If you do not operate the autoclave for a longer period please disconnect it from the power supply and empty the internal water tank Do not modify the device The autoclave must not be installed anywhere where there is a risk of explosion Do not a...

Page 10: ...der Sodium dithionite or sodium hydrosulphite Oxidising agents Potassium chlorate sodium chlorate ammonium chlorate and other chlorates Potassium perchlorate sodium perchlorate ammonium perchlorate and other perchlorates Potassium peroxide sodium peroxide barium peroxide and other inorganic peroxides Potassium nitrate sodium nitrate ammonium nitrate and other nitrates Sodium chlorite and other chl...

Page 11: ...on the program and setting the sterilisation temperature is between 105 C and 134 C Solid materials and liquids can be sterilised The autoclave has a flexible media sensor in order to measure and control the temperature directly in the medium The program parameters and sterilisation programs are displayed on the front LCD screen as well as the mobile touchscreen If a problem is discerned during th...

Page 12: ...form www certocloud com 8500212 Baseplate for bottles 8500404A Wire basket including drip pan 8500406 Distillation device for water 8500482 Log printer 1300187 Thermal paper 8500496 Label printer 8500502 Barcode reader 8500503 Direct thermal labels 8500507 5 4 Before initial start up Unpacking the autoclave This autoclave is delivered in a wooden crate The metal tabs on the bottom of the crate can...

Page 13: ...n Please leave at least 10 cm free space around the autoclave Leave at least 20 cm free space at the ventilation slits on the right of the autoclave Make sure that the room is well ventilated Keep the specified distance to the surrounding areas Failure to comply can lead to heat accumulation This could impair the function of the autoclave and shorten the service life of the pressure pump and resul...

Page 14: ...ave door please hold the UP arrow for about 3 seconds until you hear the electronic interlock humming The door now opens the you ca remove the content and continue installation 6 3 Touchscreen assembly Mount the base with the four screws supplied on the touchscreen After assembling the base the touchscreen should appear as shown in the figure opposite Connecting the touchscreen to the interface bo...

Page 15: ...table surface only You can also place the watertight touchscreen on the autoclave or next to it Connect the autoclave to the RS232 cable at the COM4 port of the extension box to the RS232 port on the rear of the autoclave Switch on the touchscreen If a login window appears on the screen after several seconds the touchscreen is correctly connected to the autoclave ...

Page 16: ...r thermal or dot matrix printer to the COM1 port of the interface box You can find the connecting cable in the box for the protocol printer Follow the instructions in the protocol printer manual 6 4 2 Connecting the barcode reader Connect the barcode reader to the USB port of the interface box You can find the connecting cable in the box for the barcode reader Follow the instructions in the barcod...

Page 17: ...stallation site Calibration method The autoclave is calibrated via the Service screen on the front of the autoclave The Calibration Menu should only be operated by trained personnel To access the Calibration Menu hold down the UP and DOWN arrow keys simultaneously for 10 seconds while switching on the autoclave To calibrate the pressure sensor to atmospheric pressure open the door of the autoclave...

Page 18: ...your dealer or contact the manufacturer directly by email To obtain instructions for calibrating the autoclave please ask your dealer for IQ OQ documentation or send an email to support certoclav com The temperature sensors should be calibrated by trained technical personnel only To access the calibration menu hold down the UP and DOWN arrow keys simultaneously for 10 seconds while switching on th...

Page 19: ...materials cannot be sterilised with this program The VACUUM TEST program performs a pressure leak test The WRAPPED programs are suitable for the sterilisation of porous material hollow bodies of type A and B packaged waste and instruments Both programs do not differ in end result If the load is temperature sensitive and cannot therefore be sterilised at 134 C please select the 121 C program The B ...

Page 20: ...tion mechanism into the autoclave These could explode due to overpressure during cooling Only fill the glasses to maximum half their capacity Please perform a vacuum test each month If the program is not completed successfully please contact your dealer or the manufacturer by email support certoclav com All programs can be customised by the user 7 2 Editing program parameters To edit the program p...

Page 21: ...ch on the autoclave at the rocker switch below the front cover 8 2 Switching off the touchscreen Press the button on the front to the right of the screen for at least 3 seconds A message will then appear on the screen Select Shutdown to switch off the screen 8 3 Standby Mode for the touchscreen Briefly press the button next to the screen The background light of the screen then switches off Press t...

Page 22: ...ion 9 2 Replenishing with distilled water The inlet to the freshwater tank is located on the cover of the autoclave Open the tank cover and full the tank with distilled water Only distilled or demineralised water is suitable for operating the autoclave Make sure that you do not overfill the tank Do not fill with more than 4 litres of water maximum If the tank has been overfilled the surplus water ...

Page 23: ... filled water If the water used to full the tank is too impure a warning message will appear on the integrated LCD screen of the autoclave and touchscreen Neither the manufacturer nor dealers are liable for damage resulting from the use of contaminated water 9 3 Opening the autoclave door To open the door click on the lock icon at the top right of the Main Menu The door then opens automatically ...

Page 24: ...ed on the touchscreen the autoclave is ready for operation 9 4 1 Selecting the sterilisation program on the screen After logging in navigate to the Sterilisation tab You will see 4 programs in the centre Scroll down in the list to view all available programs Press on a program to select it Confirm that you wish to start the program If activated in the settings step by step videos will be displayed...

Page 25: ... trace their sterilisation with CertoTrace Once an object has been scanned in it will appear in a list of the CertoTrace Scan Menu The object and the barcode are noted in the protocol of the sterilisation process After all objects have been read in and placed in the sterilisation chamber press on the Next button To terminate the CertoTrace Assistant press the Back button at the top left of the scr...

Page 26: ...loads is less than 70 of the volume of the autoclave chamber Please leave at least 10 mm free space between the load and sterilisation chamber wall To check the effectiveness of the sterilisation processes independently place the indicators or bags together with the load into the sterilisation chamber If you execute the B D or Helix program place the indicator in the centre of the sterilisation ch...

Page 27: ...ber of cycles fully automatically in succession The status of the program cycle can be called up at any time via a browser at www certocloud com or offline on the CertoClav server at http certocloud If you have activated email or SMS notifications you can call up the current status of the material test by SMS or email The email or SMS notifications can be configured in the settings You can find th...

Page 28: ...soon as the sterilisation cycle has finished Program finished is displayed on the screen and you will hear three beep sounds Return to the Main Menu and press the lock icon to open the door You can then open the door and remove the sterile load Risk of scalding Hot steam or hot water can escape from the chamber when opening the door Do not open the door until the pressure in the sterilisation cham...

Page 29: ...upplied The left port is for used water the right port is the drain for distilled fresh water Used water may be hot 9 7 PC software CertoCloud is a browser based management software package for your autoclave The software is available at www certocloud com for PC smartphone and tablets CertoCloud is also available as a laboratory internal private cloud The CertoServer must be connected to your lab...

Page 30: ...tion of user accounts directly at the autoclave or web based Tracing real time data Administration of SMS and email notifications For instance if maintenance is due Downloading of all sterilisation protocols as signed PDF Excel or ZIP file Viewing of all protocols as graphic view list or detailed view ...

Page 31: ...E 45 T 31 Validity verification of exported protocols 9 7 2 Display of sterilisation protocols via web browser To manage the autoclave and view protocols please use a browser to visit www certocloud com or http certocloud A typical protocol is shown below ...

Page 32: ... an existing CertoCloud user account with server connection press on Add an existing CertoCloud account If you wish to create a new CertoCloud user account with server connection press on Create a new CertoCloud account Enter your user data to create a new CertoCloud user account Enter your phone number including country code This is needed if you wish to receive status notifications from the auto...

Page 33: ...elect your email address from the list and then enter your password Make sure that Online Mode is activated if you wish to use a user account with server connection When you log into your CertoCloud user account for the first time you will be prompted for an activation code You should have received the activation code by SMS or email after you created your CertoCloud solution Enter this code in th...

Page 34: ...Menu Here you can watch training videos contact the CertoSupport directly from the touchscreen or order spare parts accessories or service for your autoclave 10 2 1 Tutorial videos To scroll through the list of all available videos press on the video section in the Information tab Select the required video to view it in full screen mode ...

Page 35: ...nnect a network cable to the Ethernet port or establish a WLAN connection to your WLAN router Navigate to the Information tab and press Support In the dialog window that follows select the option Send an Email to CertoSupport Now select the desired subject from the dropdown list and then enter your message in the text field Press on Send to send the email We will respond to your question within 24...

Page 36: ...ccepted if a schedule with the CertoSupport has been agreed beforehand via email or phone To arrange a time window for the remote support navigate to the Information tab and press Support In the dialog window that follows select the option Send an Email to CertoSupport Request a schedule for the remote support We will usually respond to your request within 12 hours As soon as you start a TeamViewe...

Page 37: ...s CertoSupport has joined the session we will ask your permission to split the screen Press on Allow The CertoSupport service technician is now able to service your autoclave Please wait until the technician has made the required settings to your device To cancel the screen transmission drag the TeamViewer icon to the X symbol at the bottom of the screen ...

Page 38: ...er Press on the dropdown menu above the protocol list to sort the protocols according to define criteria To display the details and graphic view select the protocol by pressing with your finger on the list element A graph of the protocol will now be shown on the right of the window To display the protocol as a list press on the list symbol above the graph 10 3 2 Printing protocols Navigate to the ...

Page 39: ...3 Protocol CertoClav Vacuum Pro Series Model VAC PRO 45L S N 22ABCDEFGHJ Program 134 C HOLLOW Program description 3 x venting 134 C 2 1bar 30min Hollow instruments wrapped or unwrapped Media NO Cycle no 971 Start time 12 01 15 17 42 00 End time 12 01 15 18 16 00 Result PASSED hh mm ss Temp C Press bar 17 42 00 27 5 1 00 17 42 20 27 5 0 50 17 42 40 27 6 0 18 17 43 00 80 4 0 80 18 15 00 65 9 0 18 18...

Page 40: ...l with shelf life date and barcode 10 3 5 Tracing marked products Navigate to the Logging tab and press on the Scan icon A dialog window appears Scan the barcode of the sterilised product with the barcode reader The protocol for the sterilised product now appears on the screen A graphic view and list view of the protocol can now be seen on the right of the screen ...

Page 41: ... Edit to change your user data and password or on Delete to delete your user account 11 2 Network settings 11 2 1 Connecting to a WLAN network Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Then press on Network If no checkmark is set at WiFi On Off press on the empty checkbox to activate WiFi After this press on Manage WiFi connections to display a list of ...

Page 42: ...ocal CertoServer If the CertoCloud is sued for synchronisation email and SMS notifications will also be available Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Then press on Network Now select Online Mode to activate or deactivate the data synchronisation Note If Online Mode is deactivated your protocols will only be saved locally on the autoclave As soon a...

Page 43: ...l CertoServer to the autoclave Connect the CertoServer to the LAN and switch in the server Connect the autoclave to the same network via Ethernet cable or WLAN Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Network and then on choose server Select the Add a server from local network option The autoclave now searches for the CertoServer in the local ...

Page 44: ...er If the autoclave is connected to the Internet you can alternatively use the free CertoCloud for documentation and configuration of the autoclave To activate communication with the CertoCloud navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Network and then on choose server Select the CertoCloud Server option ...

Page 45: ...Sterilization and then Edit user defined program Now define the program parameters individually corresponds to your requirements Number of prevacuum pumps between 1 and 10 Sterilisation temperature between 105 C and 134 C Sterilisation time between 4 and 60 minutes Drying time between 1 and 25 minutes Then press on Apply to save the program parameters or on Cancel to return to the Settings Menu an...

Page 46: ...e executed before starting it for the first time This has the advantage that longer material tests an be performed fully automatically without user interaction To activate or deactivate Material Test Mode navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Sterilization and then Material testing mode ...

Page 47: ... to the Settings Menu by clicking on the symbol at the top right of the screen Press on Sterilization and then CertoTrace load documentation After activation CertoTrace is automatically integrated in the workflow when starting a program 11 3 4 Label designer The CertoClav label printer prints shelf life data and a barcode for tracing the product on self adhesive labels You can use the integrated l...

Page 48: ...n process For this please connect a USB stick to the front USB port of the autoclave 11 3 6 Exporting all protocols to a USB The autoclave can save any number protocols internally To export all protocols to a USB stick plug a USB stick into the interface box Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Sterilization and then Export protocols to US...

Page 49: ...ocols to an SD card The autoclave can save any number protocols internally To export all protocols to an SD card plug a Micro SD card into the opened push in compartment on the right of the touchscreen Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Sterilization and then Export protocols to Micro SD Card If the protocol export fails restart the touc...

Page 50: ...s via a network Log into the autoclave with your CertoCloud or CertoServer user account Make sure that Online Mode is activated If the login is successful all protocols will be synchronised with the CertoCloud The export has been successful if checkmark icons are displayed in the protocol list ...

Page 51: ...rrow buttons and confirm the correct value with M button 11 4 2 Installing updates via the Internet Make sure that autoclave is connected to the Internet Go to the Settings Menu by clicking on the symbol at the top right of the screen Press on Device and then on Check for updates A progress display appears with the download All updates are automatically installed as soon as they are downloaded If ...

Page 52: ...toclave or in the settings For this navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Device Copy the update zip to the main directory of a USB stick and plug this USB stick into the extensive cable of the touchscreen Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Device and then on Install update from U...

Page 53: ...the push in compartment on the right of the touchscreen Navigate to the Settings Menu by clicking on the symbol at the top right of the screen Press on Device and then on Install update from external SD card If the SD card is not recognised restart the touchscreen and try again Follow the instructions on the screen to install corresponding updates 11 4 5 Restoring the default settings Navigate to ...

Page 54: ...n the Login window Note The autoclave must be connected to the Internet to be able to cerate the CertoCloud account Log in with your CertoCloud user account To configure SMS and email notifications navigate to the Settings Menu by clicking on the symbol at the top right of the screen and pressing on Notifications If you wish to receive an email if a program is terminated when maintenance is necess...

Page 55: ...e GLP and GMP settings navigate to the Settings Menu by clicking on the symbol at the top right of the screen and pressing on GLP and GMP data 11 7 1 Header The header setting activates the printout of the GLP header Up to four text lines are available If this setting is activated the header will be displayed at the top of each sterilisation protocol and printed out 11 7 2 Autoclave designation De...

Page 56: ...efault value is bold Print autoclave designation YES NO Print user identification YES NO Print project designation YES NO Print application name YES NO Print signature fields YES NO Print header YES NO Print date YES NO Print autoclave serial number YES NO 11 8 Locking settings To prevent unauthorised changes to the autoclave sensor parameters programs and settings it is only possible to change se...

Page 57: ...es The user must confirm the error message by pressing the M button for a longer period so that the error memory is deleted Code Error Possible cause Troubleshooting E 1 The program was terminated manually by the user User has pressed the STOP button during sterilisation E 2 The communication between the external touchscreen and mainboard is interrupted The serial cable COM 4 between the touchscre...

Page 58: ...current cycle E22 Vacuum pump or leak tightness Vacuum test has failed Clean the door seal and restart the process Contact your dealer if the error persists E23 Vacuum test was terminated unexpectedly The temperature in the chamber has become too hot during the program cycle Deactivate the Keep warm or Retain temperature function in the sterilisation settings and wait until the chamber has cooled ...

Page 59: ...ance and repair Make sure that autoclave is at room temperature The following components need to be checked or replaced regularly Sealing ring Safety valve Inspection plan Component Inspection by Cycle Maintenance Door Trained personnel Every 2 years See service instructions Sealing ring Trained personnel Annually See service instructions Fuse Trained personnel If the fuse has tripped Operate the ...

Page 60: ... tanks Connect the wastewater hose to the wastewater port for the fresh and used water Activate the drain by pulling on the connection port Press the connection port back towards the autoclave to stop the flow 14 3 Transport conditions Please contact your dealer Do not drop the autoclave during transport 14 4 Storage conditions The autoclave should be stored in a dry place at a room temperature be...

Page 61: ...mum operating pressure 0 21 0 23 MPa Maximum operating temperature 135 137 C Capacity of water tank 4 l Device dimensions W H D 640 560 840 mm Chamber dimensions 319 T 617 mm Chamber material Stainless steel 304L Net weight 120 kg Ambient temperature 5 40 C Relative air humidity 80 Air pressure 70 kPa Noise level 70 dB ...

Page 62: ...ction Manual CertoClav Vacuum Pro 45 l Model STE 45 T 62 16 Appendix 16 1 Appendix 1 Structural diagram V1 Vacuum pump valve V2 Air filter valve V3 Pump valve V4 Water release valve V5 Vacuum pump start valve ...

Page 63: ...am TP1 Steam generator temperature sensor TP2 Inner temperature sensor 1 TP3 Temperature sensor of chamber wall V1 Vacuum pump valve V2 Air filter valve V3 Pump valve V4 Water release valve V5 Vacuum pump start valve V6 Vacuum pump fan 16 3Appendix 3 CE Declaration of Conformity for Autoclave ...

Page 64: ...Instruction Manual CertoClav Vacuum Pro 45 l Model STE 45 T 64 ...

Page 65: ...Instruction Manual CertoClav Vacuum Pro 45 l Model STE 45 T 65 16 4 Appendix 4 CE Declaration of Conformity for Safety Valve ...

Page 66: ...Orders Dealer verification Instruction manuals Technical Support Certoclav Sterilizer GmbH Tel 43 732 674 278 Peintner Straße 10 E Mail support certoclav com A 4060 Leonding Website www certoclav com ...