Ovizio Imaging Systems ILine F Pro User manual

1
Ovizio Imaging Systems
ILine F Pro User Manual

2
Document
Author
Serge Jooris
Status
For Approval
Doc ID
I3TFG02-DOC-004
Distribution
Name
Company
Action
Jeremie Barbau
Ovizio
Review
Document History
Date
Version
Description
10/09/2014
0.0
Document Creation
22/03/2016
1.0
Update OsOne 5.0
21/03/2017
2.0
Update OsOne 5.9
26/04/2017
2.0.2
Updated legal statements
03/05/2017
2.0.3
Updated bag connection figures
08/06/2017
2.0.5
Added definition of aggregate rate
25/07/2017
2.0.6
Added dimensions in inches
12/09/2018
3.0
Update OsOne 5.12
3/10/2019
4.0
Update for iLine-F cGMP and OsOne cGMP
25/10/2019
4.1
Clarified IN & OUT of fluidic system in various figures
21/01/2020
4.2
Compliancy update
21/02/2020
4.3
Further compliancy update
21/02/2020
4.4
Further compliancy upgrade
02/03/2020
4.5
Another compliancy upgrade (symbols and LED warning)
07/04/2020
4.6
Temporarily removed Ingress Protection claim
19/05/2020
4.6.1
Clarified non consistent language: System, Reader, iLine F Pro
14/07/2020
5.0
Update manual for OsOne Pro-7.2
27/07/2020
5.1
Update manual for OsOne Pro-7.2 (typos)
04/09/2020
5.2
Removed mentions of iLine-F
Updated known issues, incl. troubleshooting and cleaning
FCC explained and operating pressure updated
08/10/2020
5.3
Compliancy upgrade (FCC statements)

3
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

4
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

5
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

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

7
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 s[email protected].
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 sup[email protected]. An Ovizio team member
will contact you to fix it.
Ovizio Imaging Systems SA/NV
Rue du Bourdon 100/2
1180 Brussels
Belgium

8
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.

9
Serial Number
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)
iLine F Pro
Symbols
Direct Current
CE Marking
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.
Protective conductor terminal
Earth terminal
Compliance
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.

10
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
−Any interruption of the electrical wiring outside the iLine F Pro will make the device hazardous.
Intentional interruption is prohibited.
−Capacitors inside the iLine F Pro may still be charged, even if the iLine F Pro has been disconnected
from all voltage sources.
−Any adjustment, maintenance and repair of the opened device under voltage must be avoided as far
as possible and, if 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
The equipment housing may become hot during normal operation.
LED RADIATION
DO NOT VIEW DIRECTLY WITH OPTICAL INSTRUMENTS
CLASS 1M LED PRODUCT

11
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
Do not lift or carry the equipment by handling the integrated pump module.
The device shall be held by its bottom plate only when being carried.
Noise
The system uses pinch valves in its normal operation. A regular clicking sound is normal.
Operating conditions
See specifications at the end of this manual

12
Introduction

13
System overview
Your online cell monitoring device is composed of two parts:
−The iLine F Pro
−The disposable probe called BioConnect.
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.
Cellculturevessel
BioConnectcartridge
BioConnectpump OvizioReader
OUT
IN
Microscope
PumpMotor

14
Anatomy of your iLine F Pro
Package contents
iLine F Pro
1 Power Adapter with Regional power plug
Description
Front
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.
Cartridgeholder
HeatSink
Pinchvalves
FrontUSB
Touchscreen
QRCodereader
USB
HDMI
PowerbuAon
Ethernet
Power
Front Back
BioConnectengine
PowerAdapter

15
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.

16
Connect

17
Get Started
Description
BioConnect drawing

18
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)
Wave-like bioreactor (this
bioreactor must have a dip tubing
on the inlet line of the BioConnect)
Connect by welding or Luer locks under sterile conditions
Interface part

19
Startup
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
1
Login to start your first monitoring session. The default guest user has limited rights.
Clickhereto
loginas
operator

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