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1 2 | User manual | Users Manual | 3.07 MiB | October 30 2020 |
Ovizio Imaging Systems ILine F Pro User Manual 1 Document Author Status Doc ID Serge Jooris For Approval I3TFG02-DOC-004 Distribution Name Jeremie Barbau Company Ovizio Action Review Document History Date Version Description 10/09/2014 22/03/2016 21/03/2017 26/04/2017 03/05/2017 08/06/2017 25/07/2017 12/09/2018 3/10/2019 25/10/2019 21/01/2020 21/02/2020 21/02/2020 02/03/2020 07/04/2020 14/07/2020 27/07/2020 0.0 1.0 2.0 2.0.2 2.0.3 2.0.5 2.0.6 3.0 4.0 4.1 4.2 4.3 4.4 4.5 4.6 5.0 5.1 Document Creation Update OsOne 5.0 Update OsOne 5.9 Updated legal statements Updated bag connection figures Added definition of aggregate rate Added dimensions in inches Update OsOne 5.12 Update for iLine-F cGMP and OsOne cGMP Clarified IN & OUT of fluidic system in various figures Compliancy update Further compliancy update Further compliancy upgrade Another compliancy upgrade (symbols and LED warning) Temporarily removed Ingress Protection claim Update manual for OsOne Pro-7.2 Update manual for OsOne Pro-7.2 (typos) Removed mentions of iLine-F 19/05/2020 4.6.1 Clarified non consistent language: System, Reader, iLine F Pro 04/09/2020 5.2 Updated known issues, incl. troubleshooting and cleaning FCC explained and operating pressure updated 08/10/2020 5.3 Compliancy upgrade (FCC statements) 2 Table Of Contents Table Of Contents .......................................................................................................................................... 3 General Notice ............................................................................................................................................... 7 Support .......................................................................................................................................................... 7 Intended use .................................................................................................................................................. 8 Serial Number ................................................................................................................................................ 9 iLine F Pro .......................................................................................................................................................... 9 Symbols ......................................................................................................................................................... 9 Compliance .................................................................................................................................................... 9 Safety Warnings ............................................................................................................................................10 General ............................................................................................................................................................ 10 Risk of electrical shock hazard ......................................................................................................................... 10 Risk of damaging the 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 contents ............................................................................................................................................. 14 Description ...................................................................................................................................................... 14 Front ................................................................................................................................................................ 14 Back ................................................................................................................................................................. 15 Cautions ........................................................................................................................................................... 15 Accessories ...................................................................................................................................................... 15 Connect .........................................................................................................................................................16 Get Started ...................................................................................................................................................17 Description ...................................................................................................................................................... 17 How to connect ............................................................................................................................................... 18 Startup ............................................................................................................................................................. 19 Logout .............................................................................................................................................................. 24 Windows sign out ........................................................................................................................................ 24 Measure ........................................................................................................................................................26 Get Started ...................................................................................................................................................27 Start the monitoring wizard ............................................................................................................................ 28 3 Monitor ........................................................................................................................................................30 Cell density, Viability and Diameter................................................................................................................. 30 Detailed views ................................................................................................................................................. 31 Live image .................................................................................................................................................... 31 Advanced results ......................................................................................................................................... 32 Pause ............................................................................................................................................................... 33 Continue .......................................................................................................................................................... 34 How a data point is acquired ........................................................................................................................... 34 Pump Operations ..........................................................................................................................................35 Stop Pumping .................................................................................................................................................. 35 Flush ................................................................................................................................................................ 36 Pump Disconnection ........................................................................................................................................ 37 Troubleshooting ............................................................................................................................................41 Introduction ..................................................................................................................................................42 BioConnect 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 good measurements..................................................................................................................... 71 Sedimentation images recording ..................................................................................................................... 71 OsOne Server ................................................................................................................................................71 Testing the web service ................................................................................................................................... 72 Testing OPC UA ................................................................................................................................................ 73 Storage Configuration ...................................................................................................................................73 Disk space ........................................................................................................................................................ 73 Remote Copy ................................................................................................................................................... 74 Secure FTP Copy .............................................................................................................................................. 75 Automatic Clean up ......................................................................................................................................... 75 Information ...................................................................................................................................................75 Logs...............................................................................................................................................................78 Audit trail ......................................................................................................................................................... 78 User actions ................................................................................................................................................. 78 4 User actions recorded in the audit trail ....................................................................................................... 79 Content of the audit trail ............................................................................................................................. 79 Audit trail location ....................................................................................................................................... 79 Users .............................................................................................................................................................79 What ................................................................................................................................................................ 79 Why ................................................................................................................................................................. 80 How.................................................................................................................................................................. 80 Built-in Roles .................................................................................................................................................... 80 Built-in users .................................................................................................................................................... 80 Create a new user ........................................................................................................................................ 81 Deleting an existing user ............................................................................................................................. 82 Security settings .............................................................................................................................................. 83 Password minimum length .......................................................................................................................... 83 Password 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 .......................................................................................................................................................89 Safety precautions ........................................................................................................................................... 89 Mains ........................................................................................................................................................... 89 High intensity light source ........................................................................................................................... 90 Replaceable parts ............................................................................................................................................ 90 Battery ......................................................................................................................................................... 90 Known issues ................................................................................................................................................... 90 Specifications ................................................................................................................................................91 ILine F Pro ........................................................................................................................................................ 91 Integration capabilities .................................................................................................................................... 91 Physical data .................................................................................................................................................... 91 Environmental conditions................................................................................................................................ 91 Power Supply ................................................................................................................................................... 92 BioConnect Device ........................................................................................................................................92 Features ........................................................................................................................................................... 92 5 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 6 General Notice 2019, Ovizio. All rights reserved. Every effort has been made to ensure that the contents of this manual are correct and up to date. The devices described in this document are protected by patents and other intellectual property rights. Ovizio and Ovizio Imaging Systems are protected brand names. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under copyright laws. The information contained in this document is subject to change without notice. Ovizio makes no warranty of any kind to this material with respect to the fitness for a particular purpose. Ovizio shall not be liable for errors contained herein or for incidental or consequential damages in connection with the supply, performance, or use of this material. The Ovizio instruments are warranted against defects in material and workmanship for 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 operation of the device, or software, will be uninterrupted or error free. The foregoing warranty shall not apply to defects resulting from improper or inadequate maintenance, unauthorized modification or misuse, operation outside of the environmental specifications for the product, or improper site preparation. Support The Ovizio support can be contacted by mail to support@ovizio.com. Software updates and online documentation are made available through the support web site at http://support.ovizio.com. A login and password are required to access your private support section and has been communicated when the microscope has been delivered. Should you meet any issue with your BioConnect disposable system or with the iLine F Pro, please send an email to support@ovizio.com. An Ovizio team member will contact you to fix it. Ovizio Imaging Systems SA/NV Rue du Bourdon 100/2 1180 Brussels Belgium 7 Intended use The system is designed for the in-line monitoring of morphological cellular parameters via a closed loop disposable probe that can be sterilized. The system is referred hereafter as the iLine F Pro (cGMP). The iLine F Pro is not classified as a medical device and as such ISO-13485 requirements do not apply. The iLine F Pro is intended to be used standalone, with the delivered power supply unit. Except for the power supply port which is used to power 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 BioConnect pump interface available on the iLine F Pro front are intended to be used with a genuine BioConnect sold exclusively by Ovizio Imaging Systems S.A. Ovizio assumes no liability for damage caused by, or any risks arising from the use of the device for purposes other than those for which it is intended, or use outside the specifications set forth by Ovizio. In case of violation of the conditions described above, the Declaration of Conformity shall be invalid. 8 The serial number of the device can be found on a sticker on the left side of the microscope when in front of you (eg. 20200313000 on the illustration below) Serial Number iLine F Pro Symbols Direct Current CE Marking Protective conductor terminal Earth terminal Compliance FCC Mark, stating the equipment is compliant with the regulations of the US Federal Communications Commission regarding electromagnetic interference Do not dispose. The equipment must be properly recycled. Safety warning. Read the user manual. Power symbol printed on the main instrument switch. Use to turn the instrument on or off. The iLine F Pro meets the requirements 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 tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 9 Safety Warnings General The manual contains information and warnings, which have to be followed by the user to ensure safe installation, operation and to retain the equipment in safe condition. If the equipment is used in a manner not specified in this manual, the protection provided by the equipment may be impaired. This equipment is designed for monitoring bioreactors and must not be used for other purposes Wear personal protective equipment adapted to lab use of system This equipment must be used by trained personnel only If the equipment is integrated in a larger system, the installation in that system and the safety of the overall system is the responsibility of the integrator of the system. The power supply unit must be connected to a power socket providing connection to earth. The equipment must be installed such that it does not obstruct the way to the power supply connecting cable. Risk of electrical shock hazard Intentional interruption is prohibited. from all voltage sources. Any interruption of the electrical wiring outside the iLine F Pro will make the device hazardous. Capacitors inside the iLine F Pro may still be charged, even if the iLine F Pro has been disconnected Any adjustment, maintenance and repair of the opened device under voltage must be avoided as far as possible and, if inevitable, the activities must only be carried out by qualified personnel. Only use the equipment with the dedicated power supply, as described in the specifications Risk of damaging the equipment In most cases, a pump is installed with the iLine F Pro. The membrane part of the pump is disposable and may get damaged after sterilization, resulting in fluid leaking into the pump engine. Make sure that there are no visible damage to the pump membrane ( See part 15 in the Connect > Get Started >
Description section) such as tears, before connecting to the pump engine. Do not use the front pump module for other purposes than connecting the BioConnect disposable The equipment needs cooling via the metal housing and the heat sink. Make sure the housing is not covered and the sides and the top have a free air flow passing. High power LED The instrument operates high power LEDs that shall not be viewed with optical instruments, but are otherwise safe for the user. Other risks 10 The equipment housing may become hot during normal operation. LED RADIATION DO NOT VIEW DIRECTLY WITH OPTICAL INSTRUMENTS CLASS 1M LED PRODUCT The use of the disposable bioconnect may lead to a higher oxygenation of the liquid due to oxygen diffusing through the tube walls into the liquid. Instructions for lifting and carrying Noise 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. The system uses pinch valves in its normal operation. A regular clicking sound is normal. Operating conditions See specifications at the end of this manual 11 Introduction 12 System overview Your online cell monitoring device is composed of two parts:
The iLine F Pro The disposable probe called BioConnect. 13 System overview The BioConnect pumps cells in closed loop from the inside 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 viability and assess their morphological parameters. The cells are finally injected back into the bioreactor. Cellculturevessel IN OUT BioConnectpump OvizioReader BioConnectcartridge Microscope PumpMotor Anatomy of your iLine F Pro Package contents iLine F Pro Description 1 Power Adapter with Regional power plug Front 14 Power Button: The power button is used to startup and turn off the device. The power button flashes blue during the boot sequence and turn green when done. Press the button 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 holder is where you insert the BioConnect cartridge. Pinch Valves: Pinch valves are used to stop the flow while acquiring a data point. Front Back Touchscreen QRCodereader Cartridgeholder BioConnectengine HeatSink FrontUSB PowerbuAon USB Power Pinchvalves HDMI Ethernet PowerAdapter BioConnect engine: The BioConnect engine couples to the pump and creates the flow QR Code Reader: Reads the QR code label on the cartridge. This lets the system know the BioConnect version and serial number for traceability. Front USB plug: Can be used to copy data or proceed to software update during maintenance operations. Touch screen: Gives access to the user interface. Back USB plugs: For maintenance purposes. Used to connect a mouse and a keyboard directly to the device embedded PC HDMI: For maintenance purposes. Used to connect a screen directly to the device embedded PC Ethernet plugs: The ethernet plug is used to connect your device to your local network. This allows remote control and data backup 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 else than a BioConnect cartridge into the cartridge holder Never clamp the input or the output of the BioConnect this may cause leaks or device malfunction Accessories BioConnect (disposable tube set) description The BioConnect has been developed to address all types of benchtop bioreactors, including disposables and rocking motion bioreactors. It is equipped at both inlet and outlet with PVC tubing for welding, or male Luer locks for connecting to female Luer locks under a LAF hood. The inlet of the BioConnect must be connected to a dip tubing that dives into the culture. The outlet of the BioConnect can be connected to a surface port, or any available port in case there is no surface port available. 15 Connect 16 Get Started Description BioConnect drawing 17 How to connect Make sure to attach the BioConnect correctly to your cell culture vessel, otherwise its sterility may be compromised. The way you connect the BioConnect to your cell culture vessel depends on your bioreactor type The BioConnect has been developed to be connected to all types of benchtop bioreactors, including disposables and rocking motion bioreactors. Bioreactor type Connection type Glass and steel benchtop bioreactor Use the interface part (see below), to be 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 equipped with a dip tubing + surface tubing, connect using either welding or Luer lock under sterile conditions If the bioreactor has a 12mm port available, autoclave the BioConnect connected to the interface piece (see below) and install the whole assembly onto the disposable vessel, under sterile conditions (LAF hood) Connect by welding or Luer locks under sterile conditions Wave-like bioreactor (this bioreactor must have a dip tubing on the inlet line of the BioConnect) Interface part 18 Startup 1 The first time you connect the adapter to the device it will startup automatically For optimal performance, always turn on the iLine F Pro 1h before starting a run. This allows the instrument 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 Pro by pressing the power button 3. Wait for the OsOne software to show on screen Login to start your first monitoring session. The default guest user has limited rights. 19 Clickhereto loginas operator A window pops up to Sign in as another user. You can now connect your BioConnect to the iLine F Pro as indicated by the orange alarm window 2 3 20 Presssignin First connect the BioConnect pump to the iLine F Pro. For that, introduce the white plastic 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 tube into the pinch valves than those directly connected to the cartridge. 4 21 MicroscopePump Motor Then insert the BioConnect cartridge into the iLine F Pro The QR code placed on the BioConnect cartridge will be read to identify its serial number for traceability purposes. 6 7 22 After successful QR code identification, the iLine F Pro will connect to the BioConnect pump. You may hear a click sound when done. During connection do not remove any part of the BioConnect from the iLine F Pro 8 9 23 Logout 10 Now the BioConnect connection is complete and you can startup a bioreactor monitoring session. If you want to switch user that has a different role, quit OsOne or change the current user password, click on the user icon in the top right corner of the screen Windows sign out 24 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 then be directed to the Windows login screen. Click on the user user to restart OsOne. Pressheretosignout.You willthenbeguestuser Pressheretoswitchto anotheruserrole PressheretoexitOsOneand returntoWindows Pressheretochangethe currentuserpassword 25 Presshereto restart OsOne Measure 26 Get Started The online suspension bioreactor monitoring application automates the online measurements of cell viability and cell density 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 Start button. A wizard will guide you through the required steps to initiate a monitoring session. 27 Clickhereto startyour monitoring session Start the monitoring wizard If it is the first time you are starting OsOne, start a new session. Give 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 flow and wait for the cells to sediment. After cell sedimentation, the system will make the autofocus. 28 29 Before the recording of 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 finally start monitoring. Monitor Cell density, Viability and Diameter After launching a monitoring session, the Live image and the computed results (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 calculated parameters are the total cell density
(TCD), viable cell density (VCD), cell viability (VIAB) and average cell diameter. 30 Detailed views Live image Click on the Live image to enlarge it. The following screen will be displayed. 31 Advanced results Click on the three dots next to the measurement figures to access advanced results 32 Clickheretosee Advanced results Pause Press the Pause Monitoring button in the lower right corner of the Measure tab to stop your monitoring session. The current monitoring session can 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. When you pause your monitoring session the pump will continue pumping cells to avoid clogging of the BioConnect. 33 Clickhereto pauseyour monitoring session Continue In the event you paused a monitoring session and want to resume it, press the Continue monitoring button to resume your last monitoring session. How a data point is acquired The pump hooked to the BioConnect has different modes of pumping over time that follow different sequences of operations. For example, one sequence 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 for statistical relevance). The pump follows this sequence of operations:
Autofocusing Acquisition of background image to compensate for permanent defects in the image, if any Acquisition of 25 images with a sedimentation time of 30 seconds between images to make sure all the cells are roughly in a layer of 50 m high by default 34 Computation of measurement based on the 25 images acquired during the previous step Wait sequence if there is enough time before the acquisition of the next data point (depends on data point acquisition frequency) Flush sequence to avoid clogging The following drawing describes a typical 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 get access to the pump menu Backup pumping refers to pumping mode when not in an active monitoring session One can stop the pump on purpose by selecting the stop pumping menu item. In that case the system will stop pumping for 10 minutes and automatically resume afterwards. Stop Pumping 35 36 Flush In the event your fluidic circuit is clogged and you get an alarm related to fluidic issues, you may 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 system displays a Flush success screen and you need to press the Finish button to get back to normal operations. Pump Disconnection 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 BioConnect pump 37 You must wait a minute the time for the membrane to be fully in low position. You will hear a click sound when the engine is actually 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 compromise the integrity of the BioConnect and lead to biological hazard. Now you can remove the BioConnect cartridge from the microscope 38 39 Now you can disconnect the BioConnect pump from the Microscope pump motor 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. 40 41 Troubleshooting Introduction Various events may occur during the setup of a bioreactor run or during the run itself such as bad quality images leading to measurement issues. In all cases the alarms or notifications are displayed with a banner on top of the live screen. The next sections describe each of them in detail. BioConnect Alarms Pump motor stalled Description:
Cause(s):
OsOne informs the user that the pump motor has stalled. 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 valve action (software bug). Wrong pump profile setting. The pump motor could be too old and not working as expected (not powerful anymore). This alarm can be triggered anytime (before or during a monitoring) when the pump is executing one of the following sequences:
Priming Flushing Backup pumping (pumping mode when not in an active monitoring session) Does it prevent from starting a monitoring?
When?
Type:
ERROR YES 42 If this error occurs during a monitoring, a software component running in the background called the Restart tool will:
Is it handled by OsOne?
Close OsOne Restart OsOne Restart the monitoring How to fix it?
Replace the BioConnect How to prevent it?
If the error is not automatically resolved after 3 consecutive tries of the Restart tool, monitoring is stopped. Check if any tubing is pinched Check in the OsOne Live image if no aggregates are present in the field of view and if yes, try to flush the fluidic system Be careful not to pinch any tubing during the setup Have the motor replaced during the maintenance if it appears that it is too old and makes noise during normal operations. Pump driver error A hardware error related to the pump motor has been detected by OsOne There was an unexpected error with the pump:
This alarm can be triggered anytime when OsOne uses the BioConnect Description:
Cause(s):
When?
Type:
ERROR 43 Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
YES YES YES Close OsOne Restart OsOne Restart the monitoring How to fix it?
If this error occurs during a monitoring, the Restart tool will:
If the error is not automatically resolved after 3 consecutive tries of the Restart tool, monitoring is stopped. 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 actions do not fix the issue, please contact Ovizio support (support@ovizio.com). How to prevent it?
There is no way to prevent that kind of error Pump communication error OsOne informs the user that there was a communication error between OsOne and pump motor. An external device may have caused electromagnetic perturbation. Damage cable or bad connection inside the microscope This alarm can be triggered anytime when OsOne uses the BioConnect Description:
Cause(s):
When?
44 Type:
ERROR YES YES YES Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
If this error occurs during a monitoring, the Restart tool will:
Close OsOne Restart OsOne Restart the monitoring If the error is not automatically resolved 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 minute and power the microscope on. If the above actions do not fix the issue, please contact Ovizio support (support@ovizio.com). How to prevent it?
There is no way to prevent that kind of error. Cannot start the pump error OsOne informs the user that there was an error when OsOne tried to start a pump sequence. OsOne tried to start a sequence while the pump was still busy Description:
Cause(s):
45 When?
Type:
ERROR YES YES YES This alarm can be triggered anytime when OsOne uses the BioConnect Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
If this error occurs during a monitoring, the Restart tool will:
Close OsOne Restart OsOne Restart the monitoring How to fix it?
If the error is not automatically resolved after 3 consecutive tries of the Restart tool, monitoring is stopped. 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 actions do not fix the issue, please contact Ovizio support (support@ovizio.com). How to prevent it?
There is no way to prevent that kind of error. Cartridge removed during monitoring OsOne informs the user that the BioConnect cartridge has been removed from the microscope during the monitoring. Description:
46 OsOne lost the connection with the BioConnect cartridge during a monitoring and then stop it. This alarm can be triggered anytime during a monitoring. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
Insert the BioConnect cartridge back into the iLine F Pro and restart the monitoring. How to fix it?
How to prevent it?
By educating the OsOne users not to remove a BioConnect cartridge during a monitoring. Backup pumping disabled Cause(s):
When?
Type:
ERROR NO YES NO OsOne informs the user that the backup pumping has been disabled. An authenticated user pressed the Stop pumping button. When the monitoring is not running When the Stop pumping button is enabled Description:
Cause(s):
When?
47 Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Type:
WARNING NO NO Is it handled by OsOne?
How to fix it?
Click the link in the alarm to reactivate the pumping. Let OsOne automatically reactivate the pumping. How to prevent it?
N/A YES. OsOne will automatically reactivate the pumping 10 minutes after it has been deactivated. 48 Insert BioConnect cartridge OsOne informs the user that in order to Start/Continue a monitoring, the BioConnect cartridge should be inserted inside the microscope. OsOne detected that no BioConnect cartridge is inserted inside the microscope. This alarm can be triggered anytime Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
YES NO N/A Is it handled by OsOne?
How to fix it?
How to prevent it?
N/A By inserting a BioConnect cartridge inside the microscope. Description:
Cause(s):
When?
Type:
WARNING 49 Calibration Alarms Calibration file missing Description:
Cause(s):
When?
Type:
ERROR YES NO How to fix it?
50 OsOne informs the user that the calibration file is missing. OsOne user>\AppData\Roaming\OsOne\Calibration folder named find not did file a CalibrationImage.h5 inside the C:\Users\<OsOne This alarm is triggered at the start of OsOne. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
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 image. NO, if the BioConnect cartridge is inserted inside the microscope at the start of OsOne. By removing the BioConnect cartridge from the microscope the time that OsOne can take a new background image. How to prevent it?
never deleting By user>\AppData\Roaming\OsOne\Calibration folder. the CalibrationImage.h5 file inside the C:\Users\<OsOne Outdated calibration file OsOne informs the user that the calibration image is outdated. The calibration image has been taken more than 30 days ago. This alarm is triggered at the start of OsOne when OsOne checks when the calibration image has been taken. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
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 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 hence blurred, leading to an equivalent background image as above NO, if the BioConnect cartridge is inserted inside the microscope at the start of OsOne and cells are not flowing How to fix it?
How to prevent it?
By removing the BioConnect cartridge from the microscope the time that OsOne takes a new background image if a monitoring session is not active. By occasionally removing the BioConnect cartridge (when OsOne is running) so that OsOne can automatically take a new background image. Description:
Cause(s):
When?
Type:
ERROR YES NO 51 Error during calibration OsOne informs the user that an error occurred while taking a new background image. A hardware error occurred while OsOne tried to capture a background image. The user inserted the BioConnect cartridge while OsOne was capturing a background image and a monitoring session is not active. This alarm is triggered while OsOne is capturing a background image (outside of a monitoring). Description:
Cause(s):
When?
Type:
ERROR YES NO NO. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
How to fix it?
How to prevent it?
There is no way to prevent that kind of error. 52 By removing the BioConnect cartridge and restarting OsOne. If restarting OsOne does not solve the issue, try to power off the microscope, then power on. If powering off and on the microscope does not solve the
(support@ovizio.com). issue, please contact Ovizio support Fluidic issue Cells in background images OsOne informs the user that a potential fluidic issue could have occurred during the monitoring. Objects have been detected in the background images. The presence of objects in the background images indicates that these objects are stuck in the flow cell because normally, the flush performed by OsOne during the acquisition of the background images should have made them disappear. This alarm is triggered during the monitoring, when OsOne completed the computation of the last recorded images. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
Stop the monitoring Start a flush sequence of 5 minutes Restart the monitoring. YES. If a fluidic issue occurs during the monitoring, OsOne will automatically (automatic flush wizard):
If this error occurs 5 times consecutively without being resolved, the above automatic actions wont be performed anymore. Measures Description:
Cause(s):
When?
Type:
ERROR NO YES 53 If the automatic flush wizard does not solve the issue, it is recommended to stop the monitoring and start a manual flush (duration = 30 minutes). How to fix it?
How to prevent it?
There is no way to prevent that kind of error. Fluidic issue Blurry images Description:
Cause(s):
When?
Type:
ERROR NO YES OsOne informs the user that a potential fluidic issue could have occurred during the monitoring. If the tubing is not inserted inside the pinch valves during the monitoring, it is possible that the cells moved during the acquisition, making the recorded images blurry. Large aggregates in the images. Bubbles in the imaging window This alarm is triggered during the monitoring, when OsOne completed the computation of the last recorded images. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
Stop the monitoring Start a flush sequence of 5 minutes Restart the monitoring. 54 YES. If a fluidic issue occurs during the monitoring, OsOne will automatically (automatic flush wizard):
If this error occurs 5 times consecutively without being resolved, the above automatic actions wont be performed anymore. How to fix it?
If the cells move during acquisition, please check if the BioConnect tubes are properly inserted inside the pinch valves. If large aggregates 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). Remark: If the cells move during the acquisition whereas the Bioconnect tubes are properly inserted inside the pinch valves, please contact Ovizio support (support@ovizio.com). How to prevent it?
To prevent the Blurry images issue, it is recommended to check the installation of the BioConnect tubes before starting 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 is remaining submersed into the liquid. Fluidic issue Non Uniform Count detection OsOne informs the user that a potential fluidic issue could have occurred during the monitoring. This alarm was triggered because the cell count values are not uniform from one recorded image to another. If the BioConnect tubes are not properly inserted inside the pinch valves during the monitoring, it is possible that the cells move during the acquisition, making the recorded images blurry. Large aggregates in the images. This alarm is triggered during the monitoring, when OsOne completed the computation of the last recorded images. Description:
Cause(s):
When?
Type:
55 Does it prevent from starting a monitoring?
ERROR NO YES Does it interrupt the monitoring?
Is it handled by OsOne?
Stop the monitoring Start a flush sequence of 5 minutes Restart the monitoring. YES. If a fluidic issue occurs during the monitoring, OsOne will automatically (automatic flush wizard):
If this error occurs 5 times consecutively without being resolved, the above automatic actions wont be performed anymore. How to fix it?
If the cells move during acquisition, please check if the Bioconnect tubes are properly inserted inside the pinch valves. If large aggregates 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?
There is no way to prevent that kind of error. Cells out of focus detected Description:
Cause(s):
When?
56 OsOne informs the user that out of focus cells have been detected during the monitoring. At the start of the monitoring, OsOne could have focused on something else (e.g.: a reflection in the image) than cells (because of low cell concentration). This alarm is triggered during the monitoring, when OsOne completed the computation of the last recorded images. This alarm is only triggered if out of focus cells are detected twice consecutively (see below Is it handled by OsOne?) Type:
ERROR NO NO Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
If OsOne detects out of focus cells in the images, it will try to correct the focus automatically without stopping the monitoring. If cells are still out of focus after this focus correction, OsOne will trigger the Out of focus cells alarm. How to fix it?
It is recommended to stop the monitoring and restart it so that a long-range auto focus is performed by the monitoring wizard. If the restart of the monitoring 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 monitoring How to prevent it?
It is recommended to look at the first images (just after having started a monitoring) and to check if the cells are in focus when OsOne is recording captures. No cell detected at startup of the monitoring OsOne informs the user that no cells have been detected when starting the monitoring, and that the monitoring has not started No cells have been detected in the image at the start of the monitoring. This alarm is triggered at the end of the monitoring wizard. Description:
Cause(s):
When?
Type:
WARNING 57 Does it prevent from starting a monitoring?
YES NO Does it interrupt the monitoring?
Is it handled by OsOne?
YES. OsOne will automatically try to find cells 5 minutes later by performing a long range autofocus. (this operation is repeated until cells are detected) How to fix it?
If cells are 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 configuration screen. Set the focus manually Start the monitoring If no cells are visible :
check if tubing is not clamped check if tubing did pop open after welding check if tubings are properly welded How to prevent it?
By starting a monitoring session when cells are visible on the Live image. 58 Hardware Description:
Cause(s):
When?
Type:
ERROR YES YES Camera error OsOne informs the user that a Camera error has been detected. OsOne could not connect with the camera There was an error during the transfer of the images This alarm can be triggered anytime YES, if this error occurs during a monitoring. In that case the Restart tool will:
Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Is it handled by OsOne?
Close OsOne Restart OsOne Restart the monitoring How to fix it?
If the error is not automatically resolved after 3 consecutive tries of the Restart tool, the monitoring could not continue because OsOne could not record any images. If this error occurs outside of a monitoring, it is recommended to restart OsOne. If restarting OsOne did not solve the issue, please try to power off the microscope, wait a minute and power the microscope on. If the issue still occurs after having power off/on the microscope, please contact the Ovizio support
(support@ovizio.com). How to prevent it?
There is no way to prevent a camera error. 59 Hardware failure OsOne informs the user that it could not connect with one (or many) of the hardware components at the start of OsOne. OsOne could not connect with one (or many) of the hardware components at startup. Description:
Cause(s):
When?
Type:
ERROR YES This alarm is triggered at the start of OsOne Does it prevent from starting a monitoring?
Is it handled by OsOne?
NO How to fix it?
Does it interrupt the monitoring?
YES, if it happens during an automatic restart performed by the Restart tool. If restarting OsOne does not solve the issue, please try to power off the microscope, wait a minute and power the microscope on. If the issue still occurs after having power off/on the microscope, please contact the Ovizio support
(support@ovizio.com). How to prevent it?
There is no way to prevent a hardware failure at the start of OsOne. 60 Microscope initialization OsOne informs the user that the microscope is being initialized. The microscope is initializing after powering the microscope on or restarting OsOne. This alarm is triggered after powering the microscope on or when restarting OsOne. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
YES NO N/A N/A Is it handled by OsOne?
How to fix it?
How to prevent it?
By waiting for the initialization process to be complete. Description:
Cause(s):
When?
Type:
WARNING 61 Storage Description:
Cause(s):
When?
Type:
WARNING Low disk space OsOne informs the user that there is not enough free disk space to start a monitoring session. The free disk space (in Gb.) is lower than the Notify when free disk space is less than value set in the Storage configuration screen. This alarm is triggered when the user presses the Start monitoring button. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
YES NO N/A Is it handled by OsOne?
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 verifying that the remote copy and the automatic clean up options are enabled. With these 2 options enabled, experiments will be automatically cleaned up from the computer. By setting a reasonable value for the Notify when free disk space is less than property. Setting this value too high (e.g.: 500 Gb) will automatically increase the risk to have this alarm triggered. By verifying that there is no connection error preventing recorded data to be remotely copied. 62 Limited monitoring duration OsOne informs the user about the day(s)/hour(s) left before the computer will run out of disk space. 63 Description:
Cause(s):
When?
Type:
WARNING The computer is almost out of free disk space. This alarm is triggered during the monitoring. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
NO NO NO Is it handled by OsOne?
How to fix it?
How to prevent 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. By verifying that the remote copy and the automatic clean up options are enabled. With these 2 options enabled, experiments will be automatically cleaned up from the computer. By verifying that there is no connection error preventing recorded data to be remotely copied. Monitoring stopped because of not enough free disk space OsOne informs the user that the monitoring was stopped because the computer was running out of free disk space. The free disk space (in Gb.) during the monitoring is lower than the Notify when free disk space is less than value set in the Storage configuration screen. This alarm is triggered during the monitoring. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
Description:
Cause(s):
When?
Type:
ERROR NO YES NO Is it handled by OsOne?
How to fix it?
How to prevent it?
64 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. By verifying that the remote copy and the automatic clean up options are enabled. With these 2 options enabled, experiments will be automatically cleaned up from the computer. By setting a reasonable value for the Notify when free disk space is less than property. Setting this value too high (e.g.: 500 Gb) will automatically increase the risk to have this alarm triggered. By verifying that there is no connection error preventing recorded data to be remotely copied. Remote copy error Description:
Cause(s):
When?
Type:
WARNING This alarm is triggered during the monitoring. Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
NO NO NO Is it handled by OsOne?
How to fix it?
OsOne informs the user that there was an error during the copy of the data (hdf5 files, csv results files) to the remote location. A connection error between the computer and the remote location Wrong remote location path. The remote location access is denied to OsOne By verifying in the storage configuration under the Remote Copy section (if the Enable copy to remote folder during monitoring is checked) that:
A valid remote path has been specified OsOne has access to this remote path (by clicking the Validate button) 65 By verifying in the storage configuration under the Secure Ftp copy (if the Enable copy to remote folder during monitoring is checked) A valid SFTP URL has been specified 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 OsOne informs the user that monitoring data (hdf5 files, csv results files) are being copied to the remote location. Description:
Remote copy in progress Cause(s):
When?
This alarm can be triggered anytime. Type:
INFORMATION 66 Does it prevent from starting a monitoring?
Does it interrupt the monitoring?
NO NO N/A N/A Is it handled by OsOne?
How to fix it?
67 Configure 68 Monitoring session configuration This section gives a description of all the configuration options related to the online monitoring of suspension cells. You must pause your monitoring session 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 logged in with Administrator rights. To access the configuration screen related to the monitoring, click on the configuration icon on the top of the Live screen and then on the monitoring icon. 69 Start the monitoring with manual focus The manual focus can be enabled 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 appear to manually adjust the focus before launching a monitoring session. 70 The frequency at which data points are acquired. Frequency Cell line The default cell line that will be selected when starting a monitoring session. Export only good measurements Property that defines if a measurement resulting from a fluidic issue is:
Added in the OsOne graphs Exported to the remote location (if the remote copy is enabled). Sedimentation images recording Records images during sedimentation to help Ovizio support define 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. Many functionalities are available such as reading measurements, starting and stopping a monitoring session. See Annex I for a comprehensive list of functionalities. By default, the following protocols are available:
RestFUL http web service OPC (UA) Enter the clients credentials to remotely authenticate to OsOne. When OsOne server is enabled, you may also want to access it through OPC (UA). For that check the Enable OsOne OPC UA Bridge box. 71 72 Testing the web service You can test the web service by opening 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 get a web page that allows you to test the various services. See OsOne Server User Manual for a comprehensive description of all possible commands. Testing 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 setting to get an alarm when the available local storage space is lower than a given size. 73 Remote Copy The remote copy functionality allows you to copy all images captured during your session to a network shared folder. Enter the path of the remote copy folder and click on Validate. This will display a pop-up window asking you to enter your credentials to access that remote folder. For each data point, the following files will be copied:
1. The hologram hdf5 files 2. <Experiment name>_<time step>_ cellcounting_features.csv: contains one line for each cell in the data point, listing all cell morphological features 3. <Experiment name>_<time step>_ cellcounting_summary.csv: contains a line for each capture acquired 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_aggregated_summary.csv: contains a summary information for all captures. The file is updated each time a new capture is created 5. <Experiment name>_<time step>_ records.txt: contains metadata about the experiment and aggregated summary for each data point (one line per data point) 6. export_logs.zip: contains all OsOne logs and OsOne Configuration information In case of connection loss, OsOne keeps track of the files that have not been copied to the remote folder. OsOne will continue the remote copy process once the connection restored and a notification banner will display the number of files that still need to be copied. 74 The remote copy functionality allows you to copy all images captured during your session to a SFTP remote folder. Enter the SFTP URL and your SFTP credentials. Then, click on Validate to ensure that the SFTP information are valid. See above the Remote Copy section for a description of the data copied during the SFTP remote copy process. Delete all files that have been safely copied to the remote location. Moreover, files are only deleted if they are older than the specified delay before cleaning up. This screen displays hardware and software information about the iLine F Pro. Scroll down to see its serial number and the OsOne software version. The Use Custom Pump Profile checkbox is for maintenance purposes only. Secure FTP Copy Automatic Clean up Information 75 76 77 Logs Audit trail User actions 78 When the microscope and its software are in use, all the actions taken by the user and the software are stored into files called log files or audit trail. In case of problems with the microscope or its software these files give crucial information about the origin of the issues. In case of problems, we recommend changing the logging level to Trace and to try to reproduce the issue. Detailed information about the microscope behavior will be recorded and can subsequently be sent to support@ovizio.com for further analysis and diagnosis. The log configuration 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. OsOne is recording all user actions inside a filed named "audittrail.log". The "audittrail.log" log file is part of the OsOne log files. User actions are actions initiated by a user or involving a user using OsOne:
from the microscope touch screen on any of the OsOne user interfaces (e.g., starting a monitoring via the touch screen by pressing the "Start" button) on disposables connected to the microscope (e.g., inserting the Bioconnect cartridge inside the microscope) remotely via OPC or via a Web service (e.g., starting a monitoring remotely via OPC) User actions recorded in the audit trail Users actions recorded in the audit trail are the actions that can:
"Users" configuration screen) modify, create or delete OsOne records (record a capture) control the microscope (e.g., start an autofocus) involve an OsOne user (e.g., user logging in OsOne) modify, create or reset the OsOne configuration (e.g., modifying the password expiration value in the Note: The audit trail 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 information:
Date and time of the action User name and role of the user logged in OsOne when an action is made Name of the executed action When the action is related to a modification of the configuration settings, the old and new values will The audit trail log file is located in the OsOne log folder (...\AppData\Roaming\OsOne\Logs\) be recorded Audit trail location Users What 79 The user management feature is meant to:
Why How Restrict access to OsOne features only to authorized and authenticated users (created by users with the Administrator role) Control what users can do in OsOne Trace users, modifications, alteration, addition of data /settings in the audit trail Guarantee of data integrity To comply with Title CFR21 part 11 (US Regulation) that regulates Electronic Records and Electronic Signatures Users are created by Administrators Users must provide valid credentials to access OsOne By giving different rights to the users By logging all authenticated users actions (failed login, deletion, modifications of data,) to an audit trail are, by informing the user By checking that the data are not corrupted, have not been modified outside the system, and if they In order to give different rights to the users, the following concepts are used:
Roles: Rather than assigning individual permissions directly to each user, permissions are grouped into roles. When users are created, they are assigned a role. Built-in Roles Built-in users The Administrator role: is the only user that can access all functionalities and create other users The Operator role: can operate the device but cannot access configuration items The Guest role: cannot do anything, is the default user at startup Users that exist by default in OsOne, they cannot be deleted and their passwords cannot be modified. For each role (except for the Guest role), there is a built-in user:
User admin for the Administrator role User guest the default user with limited rights User operator for the Operator role User engineer for the Maintenance role. For Ovizio only. The passwords of these accounts will be communicated when the software will be delivered. The first time OsOne is opened built-in users only exist. The first thing to do is to create new users. To do so, the administrator of the system first creates his own Administrator user account using the built-in user admin and its password (provided) by Ovizio. First use 80 Once his own Administrator account is created, he uses it to create OsOne users and give them different permissions according to the needs (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, in this case, multiple users may use the same account limiting the traceability of actions. Create a new user 81 Clickhereto addanew user 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. 82 Security settings Password minimum length Password maximum length Log out after inactivity Password expiration The Password minimum length setting defines the minimum length required for the password of an OsOne user. The Password maximum length setting defines the maximum length allowed for the password of an OsOne user. The "Log out after inactivity of(min.)" setting defines the duration after which an inactive user will be automatically logged out. Passwords expire after a defined amount of time (the Password expiration after (days) setting) and must be renewed during authentication. User locked after failed login attempts A failed login attempt is defined when 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 failed login attempts)"setting defines after how many failed login attempts the account of an existing user will be locked. The "Lock user duration (hours)" setting defines the time (in hour(s)) during which a user account will be locked. If your company already owns a user directory such as LDAP or Active Directory, you can leverage its users and groups in OsOne. Note that it is not possible to see the users associated with such a user directory in the OsOne Users configuration section. Moreover, it is not possible to apply security settings to such users. You will need to contact your user directory manager to correctly configure the settings below. Lock user duration LDAP 83 The table below describes the settings related to remote user management Item Meaning example LDAP Server Configuration Enable Authentication LDAP Server Url ldap.mycompany.com:636 Check the box to allow the use of external user management The address of the LDAP Server Indicate the whether server use Secure SSL or Secure authentication Domain CN=Users,DC=ldap,DC=mycompany,DC=com Account attribute mapping Account attribute mapping sAMAccountName Use SSL Users Name 84 Login Format Active Directory: %username%
OpenLDAP:
uid=%username%,cn=users,dc=ldap,dc=mycompany,dc=com Group mapping CN=ovizio-admin,CN=Groups,DC=ldap,DC=mycompany,DC=com CN=ovizio-
maintenance,CN=Groups,DC=ldap,DC=mycompany,DC=com operator CN=ovizio-admin,CN=Groups,DC=ldap,DC=mycompany,DC=com Administrator Maintenance 85 Remote Access 86 On MacOs in Finder > Go > smb://<device ip address>
On Windows in an explorer window \\<device ip address>\OsOne You will then get access to all OsOne folders OsOne Files Cache Calibration Config Experiments Logs Remote access with VNC You can access the user interface remotely by using a VNC client that you can download here https://www.realvnc.com/en/connect/download/viewer/
87 Maintenance and Servicing 88 Maintenance Cleaning The instrument can be cleaned with a soft cloth, wetted with IPA (iso propyl alcohol), if required The instrument does not contain user serviceable parts. Servicing can only be performed by a qualified technician (see chapter Servicing). A yearly maintenance is advised. Decontamination The instrument can be cleaned with a soft cloth, wetted with IPA (iso propyl alcohol), Spor-Klenz (STERIS Life Sciences) or Vesta Syde SQ Disinfectant (STERIS Life Sciences) if required. Do not spray Spor-Klenz (STERIS Life Sciences) 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 front housing can leave marks on the cloth youre using when wiping with cleaning agents. That is a known behavior and not a sign of degradation of the seal. The disposable is delivered sterile (by gamma irradiation) and should be trashed after used. It is not autoclavable. Servicing Safety precautions Mains 89 This instrument can only be used with the dedicated power supply as supplied by Ovizio (see Specifications chapter at the end of this manual). Replacement by other power supply can jeopardize safe operation of the instrument. This instrument includes a high intensity red LED light source. There is no hazard for the operators eyes when the device housing is closed. Do not stare at the light source or at the light beam during maintenance when the housing is opened. High intensity light source Replaceable parts Battery Known issues Issue The equipment is supplied with an onboard computer which contains a replaceable battery. The battery is only to be replaced by qualified personnel. Battery type CR2032 (Li-ion 3 V, 225 mA) should be used USB storage device on front usb port not recognized Unrecoverable OsOne crash due to power loss during critical file writing Workaround Try other usb storage device or one of the usb ports at the back Use UPS Restore the software configuration via your Disaster Recovery Procedure Front seal leaving marks on wipe when cleaning Accept as is. No degradation of seal. Black heatsing at the back leaving marks on wipe when cleaning Accept as is. No degradation of coating. Do not spray cleaning agent on the surface. Use other cleaning agent. 90 iLine-F Holographic transmission microscope Partially coherent monochromatic LED 630nm (Red) CMOS camera 5MPixels - 8 bits Microscope objective Olympus LUCPLFLN20X Microscope Objective 20x Specifications ILine F Pro Type Light source Sensor Total Magnification Lateral resolution Field of view Acquisition rate Data volume Cleaning agents 22.2X 1m 15fps 318m x 318m Power consumption 45W Typical, 90W Max 128Mb per measurement point Cleaning the external surfaces of the device was tested with the following 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 the imaging equipment, provides a 10% cell density variation and Cell counting range of 0.5 to 10 Mcells/mL Integration capabilities Automation via RestFUL web services OPC ready Physical data Device 400 (15.7 - L) x 223 (9.2 - W) x 423 (16.7 - H) mm 21kg Shipment box 515 x 320x 550 mm Environmental conditions General Indoor and dry use only Temperature 15 to 25C Humidity Altitude Lower than 80%, non condensing Less than 2000m above sea level Particle level The system is designed to operate in unclassified areas. 91 CUI Inc. SDI90-24-U The system is delivered with a power input cable suitable for the country of delivery 100-240VAC 10% ~50-60Hz 5%
Power Supply Brand/Model Input Cable Input Voltage Input Current Output Voltage Output Power 1.2A 24 V DC 90 W BioConnect Device Features Feature Benefits Closed-loop In-line monitoring Single-use Ready to use No sample consumption No sterility risks No cleaning required Optical quality guaranteed Less time consuming Low operational costs Automated Continuous cell culture monitoring Specifications Material of construction Fluid-contact parts are made of:
Tubing interface Polyvinyl chloride Pump body, Flow cell Connectors Polycarbonate Polypropylene Membrane, Tubing Silicone Operating parameters Operating temperature Min 15C Max 25C R.H < 80%
Operating pressure Min 0 [0] psig [mbarg] Max 7.25 [500] psig [mbarg]
92 Monitoring Duration From 4 to 30 days Total process volume From 0.3 to 10.0L total process volume1 Typical hold-up volume From 0.001 to 0.05 L Liquid hold-up duration
< 5min Typical flow rate From 4 to 12 mL/min Shelf-life Recipient Interface 6 months at storage temperature from 15 to 30 C To ensure a safe and sterile connection, the device features a PVC tubing (3,1x4,2mm IDxOD) for both inlet and outlet connection. The tubing is suitable for cut welding with most of standard welding equipment. All devices are sterilized by gamma irradiation (25 kGy) and individually packaged Double PE bag with Tyvek fast-opening. No tool required Sterilization Packaging Regulatory Compliance Quality Control All fluid-contact materials have passed the current USP Biological Test or ISO 10993 certification. Each device is individually assigned a serial number, integrity tested and certified. CoC is provided at shipping. Other documentation available upon request It complies with cGMP requirements for single-use device manufacturing. Disclaimer The BioConnect shall not be used in any clinical procedures or for diagnostic purposes unless Ovizio approved Specifications subject to change without notice. 1 Total volume required for efficient pumping and monitoring 93
1 2 | Label information (e-label) | ID Label/Location Info | 446.18 KiB | October 30 2020 |
The serial number of the device can be found on a sticker on the left side of the microscope when in front of you (eg. 20200313000 on the illustration below) Serial Number iLine F Pro Symbols Direct Current CE Marking Protective conductor terminal Earth terminal Compliance FCC Mark, stating the equipment is compliant with the regulations of the US Federal Communications Commission regarding electromagnetic interference Do not dispose. The equipment must be properly recycled. Safety warning. Read the user manual. Power symbol printed on the main instrument switch. Use to turn the instrument on or off. The iLine F Pro meets the requirements 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 tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 9 The remote copy functionality allows you to copy all images captured during your session to a SFTP remote folder. Enter the SFTP URL and your SFTP credentials. Then, click on Validate to ensure that the SFTP information are valid. See above the Remote Copy section for a description of the data copied during the SFTP remote copy process. Delete all files that have been safely copied to the remote location. Moreover, files are only deleted if they are older than the specified delay before cleaning up. This screen displays hardware and software information about the iLine F Pro. Scroll down to see its serial number and the OsOne software version. The Use Custom Pump Profile checkbox is for maintenance purposes only. Secure FTP Copy Automatic Clean up Information 75 76 77
1 2 | C2PC letter Part 1 | Cover Letter(s) | 121.90 KiB | December 15 2020 |
Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 Subject: FCC ID 2AXQY-I3TFMICG02A permissive change Dear, We, Ovizio Imaging Systems S.A., represented by Andr Lebacq, VP of Technology, hereby request to implement the permissive change as described in ANNEX I here attached, under the FCC ID mentionned in this letter subject. Best regards, Andr Lebacq. Bruxelles, le 13/11/2020 1 Ovizio Imaging Systems SA NV Rue du Bourdon 100 B-1180 Bruxelles Belgium T +32 2 600 50 90 info@ovizio.com www.ovizio.com VAT BE 821 638 597 IBAN: BE71 0688 8966 8869 BIC: GKCCBEBB Social Security 1353168-42
1 2 | C2PC letter Part 2 | Cover Letter(s) | 829.85 KiB | December 15 2020 |
ANNEX I Permissive change on iLine F PRO under FCC ID 2AXQY-I3TFMICG02A:
mPCIe RS-232 extension board 1 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A. Document Author Status Distribution Andr Lebacq Published Name Company Michael Dorongovski CTC Advanced GmbH Luk Van Hecke Ovizio Imaging Systems S.A. Jonathan Bonnevie Ovizio Imaging Systems S.A. Action Distributed Review Review Document History Date Version Description 13/11/2020 15/11/2020 0.0 0.1 Initial version Corrections 2 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A. Contents ................................................................................................................................................................ 3 Introduction ........................................................................................................................................................... 3 Change description ................................................................................................................................................ 3 Hardware change .............................................................................................................................................. 3 Software change ................................................................................................................................................ 4 Implementation ..................................................................................................................................................... 5 Validation Strategy ................................................................................................................................................ 6 Contents Introduction The iLine F PRO with hardware revision 2.1 presents an issue where the device touchscreen would turn off after a random delay spanning from some hours to several days. The issue root cause has been identified by the computer board manufacturer and located around the Chrontel chip driving the LVDS connected screen, which is not robust enough to interference created by the nearby located RS-232 communication controller which is used to communicate between the device main board and the embedded computer. The solution that Ovizio opted to implement is to add an mPCIe extension board supplying additional RS232 communication ports and establish the communication between the main board and the embedded computer through this extension board rather than through the RS232 port provided by the computer board. This solution completely bypasses the faulty controller on the embedded computer board and allows to solve the issue in a robust manner. The mPCIe extension board is made by the same manufacturer than the computer board, thus reducing the incompatibility risk. Change description Hardware change The change consists in adding an extension board to embedded computer empty mPCIe slot, and cabling the device main board to this extension board. 1. Connect MPCIE-UART-KIT02-R20 extension board to PCIe Mini Slot (MINI_PCIE1) 2. Connect the device main board (CBB) to one of the RS-232 port on the extension board. This implies replacing the communication cable (PC_RS232) from the main board (CBB - connector CN11T) to the computer by a new one from the main board to the extension board (same connector on main board side, different connector on computer side, same number of sub-cables and same length). 3 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A. Figure 1: MPCIE-UART-KIT02-R20 extension board data sheet Figure 2: WAFER-ULT4 connectors. The extension board is to be connected to the MINI_PCIE1 connectors. Software change Install the Windows driver for the RS-232 extension board. 4 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A. Modify the BIOS configuration to disable the internal RS-232 ports (COM1-2), and enable only the ports located on the extension board. Implementation Here below can be found pictures of the implementation. Figure 3: Integration of the PCIe extension board. Global view from the electronics side. 5 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A. Figure 4: Integration of the PCIe extension board. Detailed view on the computer board. Validation Strategy Ovizio Imaging Systems S.A. will ensure that the iLine F product meets its requirements after the described change by using the following strategy:
Re-testing that the device is still compatible with FCC Title 47 Part 15 for emission Extensive testing that the screen turning off issue is solved System testing to validate the functionality of the product. 6 ANNEX I Permissive Change for iLine F PRO 2AXQY-I3TFMICG02A Confidential Ovizio Imaging Systems S.A.
1 2 | LTC | Cover Letter(s) | 74.79 KiB | December 15 2020 |
CONFIDENTIALITY REQUEST for Certification Service in USA Model name iLine F PRO (I3TF-MIC-G02-A) Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 13 NOV 2020 TO WHOM IT MAY CONCERN Pursuant to Paragraphs 0.457 and 0.459 of the Commissions Rules (47 C.F.R.) and Section 552(b)(4) of the Freedom of Information Act, we requests confidentiality for the following products:
FCC ID 2AXQY-I3TFMICG02A For the product stated above, we request permanent confidentiality for exhibits which contain Operational Description, Block Diagram, Schematics, Parts Lists or Tune Up Information. The above exhibits contain our trade secrets and proprietary information that could be of benefit to our competitors. If you have any questions, please feel free to contact me at the address shown below. Sincerely,
(signed) Name: Andr Lebacq Company: Ovizio Imaging Systems S.A. Address: Rue du Bourdon 100/2, 1180 Brussels, BELGIUM Phone: +32 2 600 50 92 Fax: N/A Email: andre.lebacq@ovizio.com
frequency | equipment class | purpose | ||
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1 | 2020-12-15 | JAD - Part 15 Class A Digital Device | Class II Permissive Change | |
2 | 2020-10-30 | JAD - Part 15 Class A Digital Device | Original Equipment |
app s | Applicant Information | |||||
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1 2 | Effective |
2020-12-15
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1 2 |
2020-10-30
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1 2 | Applicant's complete, legal business name |
Ovizio Imaging Systems S.A.
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1 2 | FCC Registration Number (FRN) |
0030026553
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1 2 | Physical Address |
Rue du Bourdon 100b2
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1 2 |
Brussels, N/A
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1 2 |
Belgium
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app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@ctcadvanced.com
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1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
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app s | FCC ID | |||||
1 2 | Grantee Code |
2AXQY
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1 2 | Equipment Product Code |
I3TFMICG02A
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
J**** B****
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1 2 | Title |
Senior HArdware Engineer
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1 2 | Telephone Number |
+32 2********
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1 2 | Fax Number |
N/A********
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1 2 |
j******@ovizio.com
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app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | JAD - Part 15 Class A Digital Device | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Monitoring system | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Class II Permissive Change | ||||
1 2 | Original Equipment | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 | Grant Comments | PC2 due to hardware changes. | ||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
BGEMC Lab
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1 2 |
Signify Netherlands B.V.
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1 2 | Name |
I**** M******
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1 2 |
R******** W****
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1 2 | Telephone Number |
+32 (********
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1 2 |
+31 6********
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1 2 | Fax Number |
N/A********
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1 2 |
i******@bgemc.com
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1 2 |
r******@signify.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15B | |||||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15B |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC