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Ovizio Imaging Systems ILine F Pro, Руководство пользователя

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2 

 

Document 

 

Author 

Serge Jooris 

 

 

Status 

For Approval 

 

 

Doc ID 

I3TFG02-DOC-004 

 

 

 

Distribution 

 

Name 

 

Company 

Action 

 

 

Jeremie Barbau 

Ovizio 

Review 

 

 

 

Document History 

 

Date 

Version 

Description 

 

 

10/09/2014 

0.0 

Document Creation 

 

 

22/03/2016 

1.0 

Update OsOne 5.0 

 

 

21/03/2017 

2.0 

Update OsOne 5.9 

 

 

26/04/2017 

2.0.2 

Updated legal statements 

 

 

03/05/2017 

2.0.3 

Updated bag connection figures 

 

 

08/06/2017 

2.0.5 

Added definition of aggregate rate 

 

 

25/07/2017 

2.0.6 

Added dimensions in inches 

 

 

12/09/2018 

3.0 

Update OsOne 5.12 

 

 

3/10/2019 

4.0 

Update for iLine-F cGMP and OsOne cGMP 

 

 

25/10/2019 

4.1 

Clarified IN & OUT of fluidic system in various figures 

 

 

21/01/2020 

4.2 

Compliancy update 

 

 

21/02/2020 

4.3 

Further compliancy update 

 

 

21/02/2020 

4.4 

Further compliancy upgrade 

 

 

02/03/2020 

4.5 

Another compliancy upgrade (symbols and LED warning) 

 

 

07/04/2020 

4.6 

Temporarily removed Ingress Protection claim 

 

 

19/05/2020 

4.6.1 

Clarified non consistent language: System, Reader, iLine F Pro 

 

 

14/07/2020 

5.0 

Update manual for OsOne Pro-7.2 

 

 

27/07/2020 

5.1 

Update manual for OsOne Pro-7.2 (typos) 

 

 

04/09/2020 

5.2 

Removed mentions of iLine-F 

Updated known issues, incl. troubleshooting and cleaning  

FCC explained and operating pressure updated 

 

 

08/10/2020 

5.3 

Compliancy upgrade (FCC statements) 

 

 

Содержание ILine F Pro

Страница 1: ...1 Ovizio Imaging Systems ILine F Pro User Manual...

Страница 2: ...e for iLine F cGMP and OsOne cGMP 25 10 2019 4 1 Clarified IN OUT of fluidic system in various figures 21 01 2020 4 2 Compliancy update 21 02 2020 4 3 Further compliancy update 21 02 2020 4 4 Further...

Страница 3: ...equipment 10 High power LED 10 Other risks 10 Instructions for lifting and carrying 11 Noise 11 Operating conditions 11 Introduction 12 System overview 13 Anatomy of your iLine F Pro 14 Package conten...

Страница 4: ...ect Alarms 42 Calibration Alarms 50 Measures 53 Hardware 59 Storage 62 Configure 68 Monitoring session configuration 69 Start the monitoring with manual focus 70 Frequency 71 Cell line 71 Export only...

Страница 5: ...assword maximum length 83 Lock user duration 83 LDAP 83 Remote Access 86 OsOne Files 87 Remote access with VNC 87 Maintenance and Servicing 88 Maintenance 89 Cleaning 89 Decontamination 89 Servicing 8...

Страница 6: ...6 Specifications 92 Material of construction 92 Operating parameters 92 Shelf life 93 Recipient Interface 93 Sterilization 93 Packaging 93 Regulatory Compliance 93 Quality Control 93 Disclaimer 93...

Страница 7: ...or a period of one year from the date of shipment During the warranty period Ovizio will at its option either repair or replace products that prove to be defective Ovizio does not warrant that the ope...

Страница 8: ...wer the device the various external ports are reserved for debugging and maintenance purposes only and shall not be used during nominal use of the system The BioConnect cartridge interface and BioConn...

Страница 9: ...uirements of the following Directives of the European Union Low Voltage Directive LVD 2014 35 EU Electromagnetic Compatibility EMC Directive 2014 30 EU FCC ID 2AXQY I3TFMICG02A This equipment has been...

Страница 10: ...ill be charged even if the iLine F Pro has been disconnected from all voltage sources Any adjustment maintenance and repair of the opened device under voltage must be avoided as far as possible and if...

Страница 11: ...quid Instructions for lifting and carrying Do not lift or carry the equipment by handling the integrated pump module The device shall be held by its bottom plate only when being carried Noise The syst...

Страница 12: ...12 Introduction...

Страница 13: ...ide of the bioreactor The pump creates a flow of cells through the fluidic system contained in the cartridge The iLine F Pro uses the optical properties of your cells to count them determine their via...

Страница 14: ...n 2 seconds to turn the device off The button blinks orange during shutdown After that it remains steady orange to indicate that the device is connected to the power Cartridge holder The cartridge hol...

Страница 15: ...up on shared drives Power plug The power inlet connects the instrument to an electrical outlet through the supplied power adapter Heat sink cools the device without fan Cautions Never insert anything...

Страница 16: ...16 Connect...

Страница 17: ...17 Get Started Description BioConnect drawing...

Страница 18: ...autoclaved with bioreactor or your own interface or connect the BioConnect by welding or Luer locks in sterile conditions after sterilization Disposable benchtop bioreactor If the bioreactor is equipp...

Страница 19: ...to reach a stable internal temperature Do not check the device calibration before the device reaches a stable internal temperature 1 Connect the power adapter to the iLine F Pro 2 Turn ON the iLine F...

Страница 20: ...20 2 A window pops up to Sign in as another user 3 You can now connect your BioConnect to the iLine F Pro as indicated by the orange alarm window Press sign in...

Страница 21: ...c part Upper Housing into the microscope pump motor 5 Insert the cartridge tube into the pinch valves Any of the cartridge tubes can be inserted into any of the pinch valves Do NOT insert any other tu...

Страница 22: ...22 6 Then insert the BioConnect cartridge into the iLine F Pro 7 The QR code placed on the BioConnect cartridge will be read to identify its serial number for traceability purposes...

Страница 23: ...er successful QR code identification the iLine F Pro will connect to the BioConnect pump You may hear a click sound when done 9 During connection do not remove any part of the BioConnect from the iLin...

Страница 24: ...ndows sign out When you start the device OsOne is started automatically and the operating system behind is hidden Windows 10 If you want to close OsOne select the Windows Sign out menu item You will t...

Страница 25: ...25 Press here to restart OsOne...

Страница 26: ...26 Measure...

Страница 27: ...of any type of suspension cell culture You must login prior to be able to start a monitoring session Login as operator user by default Starting your monitoring session is as easy as pressing the blue...

Страница 28: ...ive it a name and press Next The system will start the priming step by pumping on the BioConnect line Then the system will automatically set the initial focus To do so the system will first stop the f...

Страница 29: ...data the system will also capture a so called background image This image will be used to compensate for permanent defects in the field of view Right after this sequence of operations the system will...

Страница 30: ...s values and graphs related to the investigated cell culture will be displayed on the Live screen The computed results will be updated based on the cell line configuration 30 minutes 2 hours The main...

Страница 31: ...31 Detailed views Live image Click on the Live image to enlarge it The following screen will be displayed...

Страница 32: ...32 Advanced results Click on the three dots next to the measurement figures to access advanced results Click here to see Advanced results...

Страница 33: ...then be resumed or a new monitoring session can be created When a monitoring session is paused it is also possible for the user to either flush the system stop pumping or disconnect the BioConnect Wh...

Страница 34: ...ce of operations is used during data point acquisition another during flushing operations and so on A data point is computed by averaging the counts on 25 images the number of images is set by default...

Страница 35: ...pical sequence of operations The actual sequence of operations may differ depending on your cell line for example with different sedimentation times Pump Operations You must pause your monitoring to g...

Страница 36: ...ay flush the BioConnect by running the pump continuously with higher flow rate This process will last 30 minutes by default You can stop it anytime by pressing the Stop button When completed the syste...

Страница 37: ...connection When your monitoring session has ended you will need to disconnect it from the iLine F Pro Select the Pump Disconnection menu item to proceed The pump engine will now decouple from the BioC...

Страница 38: ...decoupled Never try to remove the BioConnect pump before this operation has completed If not complete the engine may still be hooked to the BioConnect Applying force to remove the BioConnect pump may...

Страница 39: ...39 Now you can disconnect the BioConnect pump from the Microscope pump motor...

Страница 40: ...40 The BioConnect pump does not require special force Applying abnormal force to remove the BioConnect pump may compromise the integrity of the BioConnect and lead to biological hazard...

Страница 41: ...41 Troubleshooting...

Страница 42: ...ed Cause s Pinched tubing during the setup in the lab Tube welding not popped open BioConnect assembly defect internal tubing pinched Aggregates Clogging present in the cell culture Unexpected pinch v...

Страница 43: ...OsOne Live image if no aggregates are present in the field of view and if yes try to flush the fluidic system Replace the BioConnect How to prevent it Be careful not to pinch any tubing during the se...

Страница 44: ...ridge from the microscope and insert it again Power off the microscope wait a minute and power the microscope on If the above actions do not fix the issue please contact Ovizio support support ovizio...

Страница 45: ...ng is stopped How to fix it Restart OsOne Remove the BioConnect cartridge from the microscope and insert it again Power off the microscope wait a minute and power the microscope on If the above action...

Страница 46: ...after 3 consecutive tries of the Restart tool monitoring is stopped How to fix it Restart OsOne Remove the BioConnect cartridge from the microscope and insert it again Power off the microscope wait a...

Страница 47: ...handled by OsOne NO How to fix it Insert the BioConnect cartridge back into the iLine F Pro and restart the monitoring How to prevent it By educating the OsOne users not to remove a BioConnect cartrid...

Страница 48: ...rupt the monitoring NO Is it handled by OsOne YES OsOne will automatically reactivate the pumping 10 minutes after it has been deactivated How to fix it Click the link in the alarm to reactivate the p...

Страница 49: ...e the microscope Cause s OsOne detected that no BioConnect cartridge is inserted inside the microscope When This alarm can be triggered anytime Type WARNING Does it prevent from starting a monitoring...

Страница 50: ...ring YES Does it interrupt the monitoring NO Is it handled by OsOne YES if the BioConnect cartridge is not inserted at the start of OsOne in that case OsOne will automatically take a new background im...

Страница 51: ...will automatically take a new background image YES if the BioConnect cartridge is inserted and a monitoring session is started In that case OsOne acquires a background image when cells are flowing and...

Страница 52: ...arm is triggered while OsOne is capturing a background image outside of a monitoring Type ERROR Does it prevent from starting a monitoring YES Does it interrupt the monitoring NO Is it handled by OsOn...

Страница 53: ...on of the background images should have made them disappear When This alarm is triggered during the monitoring when OsOne completed the computation of the last recorded images Type ERROR Does it preve...

Страница 54: ...e cells moved during the acquisition making the recorded images blurry Large aggregates in the images Bubbles in the imaging window When This alarm is triggered during the monitoring when OsOne comple...

Страница 55: ...ng a monitoring Following items should be checked too Are the tubings correctly welded Try decreasing the rocking speed or tilt angle of the rocking motion platform Check if the dip tube entry point i...

Страница 56: ...tes are visible in the Live image and if the automatic flush wizard does not make them disappear it is recommended to stop the monitoring and start a manual flush duration 30 minutes How to prevent it...

Страница 57: ...itoring does not solve the issue it is recommended to Stop the monitoring Activate the Start monitoring with manual focus in the monitoring configuration screen Set the focus manually Start the monito...

Страница 58: ...clearly visible on the Live image but OsOne keeps making the autofocus in order to find cells Press the Pause monitoring button Activate the Start monitoring with manual focus in the monitoring confi...

Страница 59: ...rt tool will Close OsOne Restart OsOne Restart the monitoring If the error is not automatically resolved after 3 consecutive tries of the Restart tool the monitoring could not continue because OsOne c...

Страница 60: ...from starting a monitoring YES Does it interrupt the monitoring YES if it happens during an automatic restart performed by the Restart tool Is it handled by OsOne NO How to fix it If restarting OsOne...

Страница 61: ...powering the microscope on or restarting OsOne When This alarm is triggered after powering the microscope on or when restarting OsOne Type WARNING Does it prevent from starting a monitoring YES Does i...

Страница 62: ...it handled by OsOne N A How to fix it By making some free disk space or by reducing the Notify when free disk space is less than value in the Storage configuration screen How to prevent it By verifyin...

Страница 63: ...NO Does it interrupt the monitoring NO Is it handled by OsOne NO How to fix it By making some free disk space and or by reducing the Notify when free disk space is less than value in the Storage conf...

Страница 64: ...e monitoring YES Is it handled by OsOne NO How to fix it By making some free disk space and or by reducing the Notify when free disk space is less than value in the Storage configuration screen How to...

Страница 65: ...o OsOne Wrong remote location path When This alarm is triggered during the monitoring Type WARNING Does it prevent from starting a monitoring NO Does it interrupt the monitoring NO Is it handled by Os...

Страница 66: ...ecified OsOne can access this SFTP URL by clicking the Validate button How to prevent it See above the How to fix it section Remote copy in progress Description OsOne informs the user that monitoring...

Страница 67: ...67 Does it prevent from starting a monitoring NO Does it interrupt the monitoring NO Is it handled by OsOne N A How to fix it N A...

Страница 68: ...68 Configure...

Страница 69: ...ession to enable the configuration menu The available configuration options associated with a user depend on the permissions granted to the user role The following section assumes that the user is log...

Страница 70: ...bled when the system cannot automatically adjust the focus Check the related checkbox in the monitoring options Then press Done and click on the Live image of the main screen A focus slider will appea...

Страница 71: ...fine the best sedimentation time OsOne Server Enable OsOne Server if you want to access your iLine F Pro functionalities remotely with your SCADA system without the need to access the user interface M...

Страница 72: ...ening a browser on another computer or locally by entering the following URL in the address bar http IP 9000 swagger where IP is the IP address of the iLine F Pro where the Server runs You should then...

Страница 73: ...esting OPC UA Open an OPC UA client for example https github com FreeOpcUa opcua client gui and type in the following command opc tcp IP 51210 UA OvizioServer Storage Configuration Disk space Use this...

Страница 74: ...uired for the data point typically 25 with VCD and Viability as well as summary data for the data point such as average VCD TCD Viability Diameter etc 4 Experiment name _ time step _ cellcounting_aggr...

Страница 75: ...or a description of the data copied during the SFTP remote copy process Automatic Clean up Delete all files that have been safely copied to the remote location Moreover files are only deleted if they...

Страница 76: ...76...

Страница 77: ...77...

Страница 78: ...ration screen lets the user choose the number of back up files to keep and their maximum size We recommend keeping the default values unless the Ovizio support team gives you other instructions Audit...

Страница 79: ...l functionality cannot be disabled in OsOne meaning that it constantly records user actions Content of the audit trail Each action recorded in the audit trail will always contain the following informa...

Страница 80: ...directly to each user permissions are grouped into roles When users are created they are assigned a role Built in Roles The Administrator role is the only user that can access all functionalities and...

Страница 81: ...eds see below the Login and the Users section for more detailed explanations about how to accomplish these tasks Remark It could be possible to use OsOne only with the 3 built in user accounts However...

Страница 82: ...82 Deleting an existing user Press the button to delete an existing user Deleted users will still be visible inside the Name combo box They are identified by the word Disabled next to their user name...

Страница 83: ...OsOne does not recognize the combination of user name and password A user locked by OsOne won t be allowed to authenticate even if the provided credentials are valid The Lock user after number of fail...

Страница 84: ...uthentication Check the box to allow the use of external user management Server Url The address of the LDAP Server ldap mycompany com 636 Use SSL Indicate whether the server use Secure SSL or Secure a...

Страница 85: ...name cn users dc ldap dc mycompany dc com Group mapping Administrator CN ovizio admin CN Groups DC ldap DC mycompany DC com Maintenance CN ovizio maintenance CN Groups DC ldap DC mycompany DC com oper...

Страница 86: ...86 Remote Access...

Страница 87: ...window device ip address OsOne You will then get access to all OsOne folders Cache Calibration Config Experiments Logs Remote access with VNC You can access the user interface remotely by using a VNC...

Страница 88: ...88 Maintenance and Servicing...

Страница 89: ...es or Vesta Syde SQ Disinfectant STERIS Life Sciences directly on the black heatsink at the back of the instrument Do not use strong acid or base or abrasive cleaning agents The black seal in the fron...

Страница 90: ...ualified personnel Battery type CR2032 Li ion 3 V 225 mA should be used Known issues Issue Workaround USB storage device on front usb port not recognized Try other usb storage device or one of the usb...

Страница 91: ...owing agents IPA IsoPropyl Alcohol Spor Klenz STERIS Life Sciences Vesta Syde SQ Disinfectant STERIS Life Sciences Operating System Windows 10 LTBS Cell monitoring performance The device together with...

Страница 92: ...sample consumption No sterility risks Single use Ready to use No cleaning required Optical quality guaranteed Automated Continuous cell culture monitoring Less time consuming Low operational costs Sp...

Страница 93: ...e sterilized by gamma irradiation 25 kGy and individually packaged Packaging Double PE bag with Tyvek fast opening No tool required Regulatory Compliance All fluid contact materials have passed the cu...

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