2AXQY-I3TFMICG02AMonitoring system

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 .............................................................................................................................…

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CONFIDENTIALITY REQUEST for Certification Service in USA Federal Communication Commission Equipment Authorization Division, Application Processing Branch 7435 Oakland Mills Road Columbia, MD 21048 31 AUG 2020 TO WHOM IT MAY CONCERN Pursuant to Paragraphs §0.457 and 0.459 of the Commission’s 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 Model name 2AXQY-I3TFMICG02AiLine F PRO (I3TF-MIC-G02-A) 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: André 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: [email protected]

Front Back Left Right Back panel PSU

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. 75 Secure FTP Copy 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. Automatic Clean up 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”. Information 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. 76 77

iline F PRO (I3TF-MIC-G02-A) Pictures Table of Contents 1 External..............................................................................................................................................2 1.1 Front...........................................................................................................................................2 1.2 Left.............................................................................................................................................3 1.3 Back............................................................................................................................................4 1.4 Right...........................................................................................................................................5 1.5 Plug Panel...................................................................................................................................5 1.6 Labels.........................................................................................................................................6 1.7 Power Supply Unit......................................................................................................................6 2 Internal..............................................................................................................................................7 2.1 Optics Side.................................................................................................................................7 2.2 Electronics Side..........................................................................................................................8 2.3 Electronics Side (other viewpoint).............................................................................................9 2.4 Boards......................................................................................................................................10 2.4.1 Main Board (CB2) – Top...................................................................................................10 2.4.2 Main Board (CB2) – Bottom.............................................................................................10 2.4.3 Daughter Board (MCX) – Top...........................................................................................11 2.4.4 Daughter Board (MCX) – Bottom.....................................................................................11 2.5 Computer.................................................................................................................................12 2.5.1 Computer – Top................................................................................................................12 2.5.2 Computer – Bottom.........................................................................................................13 1External 1.1Front 1.2Left 1.3Back 1.4Right 1.5Plug Panel 1.6Labels 1.7Power Supply Unit 2Internal 2.1Optics Side 2.2Electronics Side 2.3Electronics Side (other viewpoint) 2.4Boards 2.4.1Main Board (CB2) – Top 2.4.2Main Board (CB2) – Bottom 2.4.3Daughter Board (MCX) – Top 2.4.4Daughter Board (MCX) – Bottom 2.5Computer 2.5.1Computer – Top 2.5.2Computer – Bottom

Signify Innovation labs EMC & Wireless connectivity lab High Tech Campus 26 5656AE, Eindhoven, The Netherlands Tel. +31 06 43842446 Email [email protected] EMC TEST REPORT iLine F PRO EMC-20-TRP-6145-502 Date : 23 September 2020 Page : 1 of 21 Customer : Ovizio imaging systems Name : Mr. Jonathan Bonnevie Address : Rue du Bourdon 100/2 Zip / City : 1180 Brussels Country : Belgium Equipment Under Test (including peripherals): Model Name : iLine F PRO Identification : Product Code: I3TF-MIC-G02-A Serial Number: 20200313010 Description : The equipment is designed for the in-line monitoring of morphological cellular parameters via a closed loop disposable probe that can be sterilized. EMC Standards : FCC part 15B: 2020-04 Class A ANSI C63.4: 2014 Test result : Passed Note 1 : The results in this report apply only to the sample(s) and modes tested. It is the manufacturer’s responsibility to assure the continued EMC compliance of production models. Note 2 : This report replaces and invalidates EMC-20-TRP-6145-501, Editorial changes applied. Date of receipt of EUT : 18 August 2020 Date(s) of performance of test : 18 August 2020 ———————— Eindhoven, Wouter Maes The Netherlands Head of Innovation labs  Signify Netherlands B.V. Created from QS-001116 This report shall not be reproduced except in full, without the written approval of the testing laboratory Customer warrants that the information provided to Signify EMC&Wireless Connectivity lab is complete, accurate and true, and Customer acknowledges that a failure to provide complete, accurate and true information or instructions to Signify EMC&Wireless Connectivity lab may detrimentally affect Signify EMC&Wireless Connectivity lab’s ability to provide an accurate report. Signify EMC&Wireless Connectivity lab does not give any representation or warranty as to the accuracy or completeness of the report based on data provided by customer. Signify EMC&Wireless Connectivity lab shall not be liable for any action in reliance thereon. The information (data) provided by the customer or derived from the EUT(s) label(s) are identified in this report (section 3.1) are in italic font. Reference: EMC-20-TRP-6145-502 iLine F PRO Date: 23 September 2020 Signify Innovation labs; EMC & Wireless connectivity lab Page 2 of 21 Table of contents 1. Responsibilities ........................................................................................................................................................... 2 2. Summary of test results .............................................................................................................................................. 3 2.1 Deviations from the standard ............................................................................................................................ 3 3. Measurements/tests ..................................................................................................................................................... 4 3.1 General .............................................................................................................................................................. 4 3.1.1 Short description of the Equipment Under Test according Customer Specification ..................................... 4 3.1.2 List of tested equipment (Tested configuration of EUT and peripherals) ..................................................... 5 3.1.3 Cable connections made ............................................................................................................................... 5 3.1.4 Monitoring of the Equipment Under Test ..................................................................................................... 6 3.1.5 Clock frequencies / highest frequency used in the Equipment Under Test ................................................... 7 3.1.6 Modifications to achieve compliance / Declaration of customer .................................................................. 7 3.2 Conducted emissions ......................................................................................................................................... 8 3.3 Radiated spurious emissions ........................................................................................................................... 10 4. Equipment list ........................................................................................................................................................... 14 5. Measurement uncertainties ....................................................................................................................................... 15 6. Photographs of test set-ups ....................................................................................................................................... 16 6.1 Conducted emissions ....................................................................................................................................... 16 6.2 Radiated emissions .......................................................................................................................................... 17 6.3 Photograph of EUT label ................................................................................................................................. 19 6.4 Ancillary equipment ........................................................................................................................................ 20 7. References ................................................................................................................................................................ 21 1. Responsibilities EMC Test Engineers: E-Mail Signature Mario van Munster [email protected] Reviewed by: E-Mail Signature Edwin van Niftrik [email protected] Reference: EMC-20-TRP-6145-502 iLine F PRO Date: 23 September 2020 Signify Innovation labs; EMC & Wireless connectivity lab Page 3 of 21 2. Summ…

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1. Photographs of test set-ups 1.1 Conducted emissions Photograph of conducted emissions test set-up. 1.2 Radiated emissions Photograph of radiated emissions test set-up. Photograph of radiated emissions test set-up. 1.3 Photograph of EUT label Photograph of EUT label. 1.4 Ancillary equipment Photograph of ancillary equipment.