FCC ID: 2AFDI-ITCOQ626S 802.11A/B/G/N/AC WiFi + Bluetooth Module

Intrinsyc Open-QTM 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide

[Document: ICS-01RND1278-TN-068 Revision: 1.1]

NOTICE TO PERSONS RECEIVING THIS DRAWING AND/OR TECHNICAL INFORMATION INTRINSYC Technologies Corp. claims proprietary rights to the material disclosed hereon. This drawing and/or technical information is issued in confidence for engineering information only and may not be reproduced or used to manufacture anything shown or referred to hereon without direct written permission from INTRINSYC Technologies Corp. to the user. This drawing and/or technical information is the property of INTRINSYC Technologies Corp. and is loaned for mutual assistance, to be returned when its purpose has been served. Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 Identification Document Title Intrinsyc Open-QTM 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Document Number ICS-01RND1278-TN-068 Version Date 1.1 May 21, 2019 History REVISION DATE DESCRIPTION 1.0 Mar 28, 2019 Original Document 1.1 May 21, 2019 Corrected typo on Title page and changed formatting of Allowable Antennas section, updated Antenna Gain in Antenna Information for Industry Canada and added 5GHz statement in FCC Interference Statement and Industry Canada Statements. Removed duplicate Antenna information on page 10 that is already on page 4. PAGES All Title, 4, 9,10 Note: The Intrinsyc Open-QTM 626 SOM radio module (the Module) is certified for compliance for use in the USA and Canada only. For use in other countries, certificates of compliance must be obtained for that country or region before the module can be sold, operated or incorporated into products. In addition, any deviation from the settings, methods, conditions and restrictions for integration of the Module into a host system, as defined in this document, could be a violation of applicable national law and may be punishable as such, and in such event, the products into which the Module is incorporated may not be lawfully distributed or sold in such countries. Intrinsyc assumes no responsibility for any such liability or loss related to installation or operation of the Module. 1 Copyright Intrinsyc Technologies Corporation Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 Table of Contents 1. 2. INTRODUCTION ................................................................................... 3 APPLICABLE MODULE ....................................................................... 3 ADDITIONAL REGULATORY CONFORMANCE TESTING AND/OR 3. SUBMISSIONS REQUIRED BY THE INTEGRATOR ..................................... 3 4. 5. 6. COMPLIANT/ALLOWABLE TX POWER SETTINGS .......................... 3 ALLOWABLE ANTENNAS TO USE WITH THE RADIO MODULE ..... 4 ANTENNA PLACEMENT AND RF SAFETY ........................................ 5 7. SIMULTANEOUS TRANSMISSION WITH OTHER INTEGRATED OR PLUG-IN RADIOS ........................................................................................... 6 8. 9. MODULE MAY NOT BE INSTALLED BY END USERS ...................... 6 REQUIRED LABELING ON THE OUTSIDE OF THE HOST................ 6 9.1 FCC Labeling Requirements on the Outside of the Host .................................. 6 9.2 Industry Canada Labeling Requirements on the Outside of the Host ............... 7 10. REQUIRED LABELING ON THE MODULE ......................................... 8 10.1 FCC and Industry Canada Labelling on the Module ....................................... 8 11. REQUIRED REGULATORY WORDING FOR END USER MANUAL /

INSTALLATION MANUAL .............................................................................. 8 11.1 FCC Requirements for End User Manual / Installation Manual ..................... 8 FEDERAL COMMUNICATIONS INTERFERENCE STATEMENT .................. 8 FCC RF Exposure Requirements: ........................................................................... 9 11.2 Industry Canada Requirements for End User Manual / Installation Manual . 10 Industry Canada Statements .................................................................................. 10 Radiation Exposure Statement ............................................................................... 11 Dclaration d'exposition aux radiations ................................................................. 11 12. OEM INTEGRATOR CHECKLIST ...................................................... 13 Copyright Intrinsyc Technologies Corporation 2 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 1. INTRODUCTION This document describes the steps that the OEM integrator must follow when designing and manufacturing a system utilizing the Open-QTM 626 SOM Transmitter Module. Failing to follow the instructions in this document may invalidate the FCC and IC (Industry Canada) certifications and authorizations of the Module for use in the U.S. and Canada. The Module certifications described in this document apply only to radio conformance for the Module. The OEM integrator is responsible for all system-level EMI/EMC and Product Safety testing and certifications that apply to the host system in the U.S. and other countries where the system will be marketed or sold. 2. APPLICABLE MODULE Model USA/FCC CANADA/IC Open-QTM 626 SOM 2AFDI-ITCOQ626S 9049A-ITCOQ626S 3. ADDITIONAL REGULATORY CONFORMANCE TESTING AND/OR SUBMISSIONS REQUIRED BY THE INTEGRATOR The modular certifications apply to the radio conformance for the Module only. The OEM integrator is responsible for additional system-level EMI/EMC and Product Safety testing and certification that applies in the U.S. and other countries to the host system containing the Module. This includes but is not limited to Federal Communications Commission (FCC) Part 15 Class B Digital Emissions. These system-level EMC tests are to be done with the Module installed and included in the scope of the submission. Some of the countries for which modular certifications are provided require additional submissions, authorizations or import permission by the system-vendor or importer. The integrator is responsible for these additional actions. Modular radio certification is not possible in some countries. For such countries, OEM integrators must ensure radio certification for the end system is obtained, before placing the product on the market. 4. COMPLIANT/ALLOWABLE TX POWER SETTINGS Any adjustments made to increase transmit power settings will invalidate all radio certifications for this module. Copyright Intrinsyc Technologies Corporation 3 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 5. ALLOWABLE ANTENNAS TO USE WITH THE RADIO MODULE The module is certified for use with certain antennas as described in this section. Allowed Antenna Types:

1. Dipole antenna Table 1 Allowed Maximum Gain (dBi) Dipole, Including Cable Loss 2.4~2.5GHz 4.9~5.8GHz 3.32 6.11 The required antenna impedance is 50 ohms. Use of other antenna types or the same type of antenna but with higher gain than listed above is not allowed without additional testing and appropriate FCC or IC approval. Use of a similar antenna may only require a C1PC to confirm the performance for SAR is the same or better (i.e. lower) but only an equivalent antenna can be used without any additional testing. Copyright Intrinsyc Technologies Corporation 4 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 6. ANTENNA PLACEMENT AND RF SAFETY The FCC and other countries regulatory bodies impose strict conditions and limitations on the RF exposure levels of end products. Acceptable RF exposure levels for this Module depend on transmit power, the location of the transmitting antenna(s) inside the host system and the expected separation of the transmitting antennas to the end user. OEM integrators must take great care to ensure each host system complies with the applicable RF exposure requirements. The antenna-to-user (bystander) separation distance must be greater than 20 cm. Failure to adhere to these separation/spacing rules will invalidate the FCC and IC certifications for the Module. This separation is measured between the closest point of each transmitting antenna inside the host device to the point of contact by the user or nearby person outside the host device. For notebooks/netbooks/laptops with antennas in display section, the LCD is opened 90 degrees/perpendicular to the keyboard. The separation distance is then measured from the nearest point of each transmitting antennas to the bottom of the host. Use in the keyboard section of a netbook or laptop or use in a tablet device or convertible tablet would require host-specific testing. For notebooks/netbooks/laptops, the transmitting antenna cables shall be positioned away from the antenna elements to conform to the configuration tested for compliance. When transmitting antennas are installed in the display section of notebook/netbook/laptops, the display section shall not have metallic components and material that can influence or change the operating and RF exposure characteristics of the antennas. The separation between the main and aux antennas must be at least 3 cm. The transmitter module may not be co-located with any other transmitter or antenna. SAR evaluation is required if the separation distance between the user or bystanders and the device is less than or equal to 20 cm. Where one or more of the conditions above cannot be met for a particular host system, additional testing is required to secure the necessary certifications for the system. Note: These restrictions do not apply to receive-only antenna. Copyright Intrinsyc Technologies Corporation 5 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 7. SIMULTANEOUS TRANSMISSION WITH OTHER INTEGRATED OR PLUG-IN RADIOS The FCC and IC impose conditions and limitations when additional radio(s) are co-located in the same host system as the Module with capability to transmit simultaneously. Co-

locating other radios such as an integrated or plug in Wireless WAN/cellular radio with the Module requires additional evaluation and possibly submission for authorization from the FCC and IC. Because the rules are highly dependent on the characteristics of the particular radios that are co-located and simultaneously transmitting, the OEM integrator should seek guidance from a knowledgeable test lab or consultant to determine if additional testing and certification is required. In this case, failure to evaluate and follow the required FCC and IC procedures will invalidate the FCC and IC certifications of the Module and end system. 8. MODULE MAY NOT BE INSTALLED BY END USERS FCC and IC rules require this Module to be installed in host systems at the factory by the OEM integrator. Thus, end users of the system may not install the Module. Therefore, the host product user instructions must not advise the end user on how to access or remove the Module. Additional FCC authorization/filing is needed to allow end user installation of the radio modules. If modules are provided to the end users for installation in the host, a two-way authentication protocol is required to limit the module to operate only with the authorized host system. 9. REQUIRED LABELING ON THE OUTSIDE OF THE HOST 9.1 FCC Labeling Requirements on the Outside of the Host The FCC requires a label on the outside of the host system visible to the end user. Example wording is:

Contains:

FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Copyright Intrinsyc Technologies Corporation 6 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 The FCC requires a logo signifying emission compliance on the outside of the host system. The OEM integrator is responsible to perform FCC Part 15 Class B digital emissions testing on the end system with the radio Module installed. The FCC logo below should not be affixed unless the OEM integrator has obtained the necessary Part 15 approval, e.g., self-

declaration of conformity. If the host system is approved to FCC Class B digital emissions limits under a grant of certification issued by a TCB, the FCC ID number shown on the grant should be used on the label instead of the FCC logo below. Also see https://www.fcc.gov/logos. A certified modular has the option to use a permanently affixed label, or an electronic label

(Refer to FCC KDB 784748 D02 e labeling for e-labelling guidance). All modules without an integrated display on the module must be labelled with a modules FCC ID - Section 2.926. 9.2 Industry Canada Labeling Requirements on the Outside of the Host End Product Labeling The final end product must be labeled in a visible area with the following for the Open-QTM 626 SOM: Contains IC: 9049A-ITCOQ626S. Plaque signaltique du produit final Le produit final doit tre tiquet dans un endroit visible avec l'inscription suivante:

Open-QTM 626 SOM: Contient des IC: 9049A-ITCOQ626S. Copyright Intrinsyc Technologies Corporation 7 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 10. REQUIRED LABELING ON THE MODULE 10.1 FCC and Industry Canada Labelling on the Module The OEM integrator must ensure that the FCC ID and IC number is affixed on the Module or in a User/Installation Manual along with other country certification numbers and logos as described herein. Note: the original Module manufacturer may affix regulatory labeling at time of Module manufacturing. However, the OEM integrator must ensure that Module labeling is complete, correct, and applicable for all the countries to which the host system is to be imported, marketed, or sold. 11. REQUIRED REGULATORY WORDING FOR END USER MANUAL / INSTALLATION MANUAL 11.1 FCC Requirements for End User Manual / Installation Manual The OEM integrator must provide instructions in the end user manual how to retrieve the module FCC ID for host devices using electronic labeling (for example an integrated display) in lieu of a physical label or nameplate to meet the labelling requirements of Industry Canada (Refer to FCC KDB 784748 D02 e labeling document for guidance). The OEM integrator must include text in the end user manual (meeting the regulators requirements. When the module is installed inside another device, the user manual of that device must contain the statements and warnings below (text in red font must be replaced):

FEDERAL COMMUNICATIONS INTERFERENCE STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This product does not contain any user serviceable components. Any unauthorized product changes or modifications will invalidate warranty and all applicable regulatory certification and approvals, including authority to operate this device. FCC Part 15 Digital Emissions Compliance We [System Manufacturer Name, Address, Telephone], declare under our sole responsibility that the product [System Name] complies with Part 15 Rules. Operation is Copyright Intrinsyc Technologies Corporation 8 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. WARNING: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and radiates radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of more of the following measures:

Reorient or relocate the receiving antenna. Connect the equipment into an outlet on a circuit different from the one the receiver Increase the separation between the equipment and receiver. is connected to. Consult the dealer or an experienced radio or TV technician for help.

(Notice for 5GHz and/or when co-located with 5GHz transmitters, the following statements should be provided for user information.) Operations in the 5.15-5.25GHz band are restricted to indoor usage only. (For 5GHz only) IMPORTANT! Changes or modifications not expressly approved by [System Manufacturer Name] could void the users authority to operate the equipment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. FCC RF Exposure Requirements:

This product complies with the FCC RF exposure limit set forth for an uncontrolled environment and is safe for intended operation as described in this manual. This device is only authorized for use in a mobile application, at least 20 cm of separation distance between the radiating antenna and the user's body must be maintained at all times. Further RF exposure reduction can be achieved if the product can be kept as far as possible from the users body or set the device to a lower output power if such a function is available. Separate approval is required for all other operating configurations, including portable configurations with respect to 47 CFR Part 2.1093 and different antenna configurations. Copyright Intrinsyc Technologies Corporation 9 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 11.2 Industry Canada Requirements for End User Manual / Installation Manual Industry Canada Statements This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) This device may not cause interference, and (2) This device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:

(1) lappareil ne doit pas produire de brouillage;

(2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement.

(Notice for 5GHz and/or when co-located with 5GHz transmitters, the following statements should be provided for user information.) Caution:

(i) the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems;

(ii) the maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 5470-5725 MHz shall comply with the e.i.r.p. limit; and

(iii)the maximum antenna gain permitted for devices in the bands 5725-5825 MHz shall comply with the e.i.r.p. limits specified for point-to-point and non point-to-point operation as appropriate.

(iv) Users should also be advised that high power radars are allocated as primary users

(i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices Avertissement:

Le guide d'utilisation des dispositifs pour rseau-x locaux doit Inclure des instructions pccises su:r les restrictions susmentionnes, notamment:

(i) les dispositifs fonctionnant dans la bande 5150-5250 MHz sont rservs uniquement pour une utilisation intrieur afin de rduire les risques de brouillage prjudiciable aux systmes de satellites mobiles utilisant les mmes canaux;

(ii) le gain maximal dantenne permis pour les dispositifs utilisant les bandes 5150-5250 MHz et 5470-5725 MHz doit se conformer la limite de p.i.r.e.;

(iii)le gain maximal d'antenne permis (pour les dispositifs utilisant la bande 57255825 MHz) doit se conformer la limite de p.i.r.e. spcifie pour l'exploitation point point et non point point, selon le cas. Copyright Intrinsyc Technologies Corporation 10 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1

(iv) De plus, les utilisateurs devraient aussi tre aviss que les utilisateurs de radars de haute puissance sont dsigns utilisateurs principaux (c.--d ., qu'ils ont la priorit) pour les bandes 5250-5350 MHz et 5650-5850 MHz et que ces radars pourraient causer du brouillage et/ou des dommages aux dispositifs LAN-EL. Radiation Exposure Statement This equipment complies with radiation exposure limits set forth for uncontrolled environment. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be collocated or operating in conjunction with any other antenna or transmitter. Dclaration d'exposition aux radiations Cet appareil se conforme aux limites d'exposition aux rayonnements pour un environnement non contrl. L'antenne (s) qui est utilis pour cet metteur doit tre install pour produire une distance de sparation d'au moins 20 cm de toutes personnes et ne doit pas tre install proximit ou utilis en conjonction avec une autre antenne ou metteur. This device is intended only for OEM integrators under the following conditions:

1. The antenna used will be of the same type and have an antenna gain which is the same or less than what is listed in this document. 2. The antenna must be installed such that 20 cm is maintained between the antenna and users. 3. The transmitter module may not be co-located with any other transmitter or antenna. As long as the conditions above are met, further transmitter tests will not be required. However, the OEM integrator is still responsible for testing the end product and any additional compliance requirements required with this module installed. Cet appareil est conu uniquement pour les intgrateurs OEM dans les conditions suivantes:

1. L'antenne utilise sera du mme type et aura un gain d'antenne identique ou infrieur ce qui est indiqu dans ce document. 2. L'antenne doit tre install de telle sorte que 20 cm est maintenue entre l'antenne et les utilisateurs. 3. Le module metteur peut ne pas tre co-localis avec un autre metteur ou antenne. Tant que les conditions ci-dessus sont remplies, d'autres tests d'mission ne seront pas ncessaires. Cependant, l'intgrateur OEM est toujours responsable pour tester le produit final et toutes les exigences de conformit supplmentaires ncessaires avec ce module install. Important Note:

In the event that these conditions cannot be met, then the Canadian authorization is no longer considered valid and the IC ID cannot be used on the final product. In these Copyright Intrinsyc Technologies Corporation 11 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide Rev. 1.1 circumstances, the OEM integrator will be responsible for re-evaluating the end product

(including the transmitter) and obtaining a separate Canada authorization. Note Importante:

Dans le cas o ces conditions ne peuvent tre satisfaites, l'autorisation du Canada n'est plus considr comme valide et l'ID IC ne peut pas tre utilis sur le produit final. Dans ces circonstances, l'intgrateur OEM sera charg de rvaluer le produit final (y compris l'metteur) et l'obtention d'une autorisation distincte au Canada. Manual Information to the End User The OEM integrator has to be aware not to provide information to the end user regarding how to install or remove this RF module in the users manual of the end product which integrates this module. The end user manual shall include all required regulatory information/warning as shown in this manual. The OEM integrator must provide instructions in the end user manual how to retrieve the module IC number for host devices using electronic labeling (for example an integrated display) in lieu of a physical label or nameplate to meet the labelling requirements of Industry Canada (Refer to IC Notice 2014-DRS1003 for guidance). Manuel d'information l'utilisateur final L'intgrateur OEM doit tre conscient de ne pas fournir des informations l'utilisateur final quant la faon d'installer ou de supprimer ce module RF dans le manuel de l'utilisateur du produit final qui intgre ce module. Le manuel de l'utilisateur final doit inclure toutes les informations rglementaires requises et avertissements comme indiqu dans ce manuel. L'intgrateur OEM doit fournir des instructions dans le manuel utilisateur expliquant comment rcuprer le numro IC du module pour les appareils htes en utilisant l'tiquetage lectronique (par exemple un cran intgr) en lieu et place d'une tiquette physique ou plaque signaltique pour rpondre aux exigences en matire d'tiquetage d'Industrie Canada

(Se reporter la note d'IC 2014 - DRS1003 pour plus d'information). Copyright Intrinsyc Technologies Corporation 12 Intrinsyc Open-Q 626 (APQ8053) SOM Module Certification Technical Note 68: OEM Integrator Guide 12. OEM INTEGRATOR CHECKLIST Rev. 1.1 The OEM Integrator will integrate the Module in the host systems in accordance with the instruction specified in this document and the documents referenced herein. The OEM Integrator will ensure the Module is integrated in a host system using only antennas that are of the same type and having equal or less antenna gain as described in this document. The OEM Integrator will ensure the antennal placement inside the host system will maintain the required spacing to the end user for RF Exposure compliance, as specified in this document. If other radios are integrated inside the host with the Module, the OEM Integrator will contact a test lab or TCB to determine if additional FCC compliance evaluation is required to meet FCC collocation rules. The OEM Integrator will ensure end user documentation will contain the specified regulatory wording and ensure the host system and the Module itself is labeled as specified in this document. The OEM Integrator will ensure that nothing is done that will change the transmit power level of the module. The OEM Integrator will ensure end user documentation will contain clear instructions on how to access the FCC ID and IC Number of the module should an electronic display (e-labeling) be used to meet the FCC and IC labeling requirements

(Refer to FCC KDB 784748 D02 e labeling document and IC Notice 2014-DRS1003 for guidance). Copyright Intrinsyc Technologies Corporation 13

Eagle V1.2 Imaging System Instructions for Use For use exclusively by authorized healthcare professionals in accordance with SBI-CIP 20-002:

A prospective multi-center clinical study evaluating the use of PD G 506 A and the Eagle V1.2 Imaging System for the visualization of carcinoma during breast conserving surgery Contact Information:

Address:

SBI ALApharma Canada Inc. 123 Edward St., Suite 305 Toronto, ON M5G 1E2 Canada Email:

SBI-ALApharma-PhV@spmd-safety.com Document Information:

Instructions for Use Information:

PN 10232 Rev 1.0 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 1 of 101 Contents 1. i. ii. Introduction .......................................................................................................................................... 6 CSS Custom Sterile Sleeve .................................................................................................................. 6 ECH External Communication Hub ..................................................................................................... 6 iii. DIS Dark Imaging Sheet ...................................................................................................................... 6 iv. DIB Dark Imaging Box ......................................................................................................................... 6 v. CCD Contact Charging Device ............................................................................................................ 6 vi. PSC Protective Storage Cradle ........................................................................................................... 7 1.1. Intended Use/Indications for use Eagle V1.2 Imaging System ................................................ 7 1.2. Intended Use/indication for use PD G 506 A ............................................................................ 7 1.3. Clinical Need ................................................................................................................................. 7 1.4. Principles of Operation ................................................................................................................ 7 1.4.1. ALA and Protoporphyrin (PpIX) Production ........................................................................ 8 1.4.2. Fluorescence Imaging ........................................................................................................... 9 1.1. Regulatory Information .............................................................................................................. 12 1.2. Terminology Used ...................................................................................................................... 13 2. Eagle V1.2 Imaging System Contents ................................................................................................. 14 2.1. HCF Handheld Fluorescence Camera ...................................................................................... 17 2.1.1. HFC Optical Head ................................................................................................................ 17 2.2. Accessories and Consumables ................................................................................................... 19 2.2.1. CSS Custom Sterile Sleeve ............................................................................................... 19 2.2.2. ECH External Communication Hub .................................................................................. 20 2.2.3. DIS Dark Imaging Sheet ................................................................................................... 23 2.2.4. DIB Dark Imaging Box ...................................................................................................... 24 2.2.5. CCD Contact Charging Device .......................................................................................... 26 2.2.6. PSC Protective Storage Cradle......................................................................................... 28 3. Safety Information ............................................................................................................................. 29 3.1. Certifications .............................................................................................................................. 29 3.1.1. HFC Handheld Fluorescence Camera .............................................................................. 29 3.1.2. CSS Custom Sterile Sleeve ............................................................................................... 29 3.1.3. ECH External Communications Hub ................................................................................ 29 3.1.4. DIS Dark Imaging Sheet ................................................................................................... 30 3.1.5. DIB Dark Imaging Box ...................................................................................................... 30 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 2 of 101 3.1.6. CCD Contact Charging Device .......................................................................................... 30 3.1.7. PSC Protective Storage Cradle......................................................................................... 30 3.2. Classification ............................................................................................................................... 30 3.2.1. Electromagnetic Compatibility .......................................................................................... 31 3.2.2. Radiation Output ................................................................................................................ 33 3.3. Warning, Cautions, and Notes ................................................................................................... 33 3.3.1. General Warnings ............................................................................................................... 33 3.3.2. General Cautions ................................................................................................................ 35 3.3.3. General Note ...................................................................................................................... 36 4. Labelling .............................................................................................................................................. 37 4.1. HFC Handheld Fluorescence Camera Device Label ................................................................ 37 4.1.1. Symbols on HFC Device Label ............................................................................................ 37 4.2. CSS Custom Sterile Sleeve Device Label ................................................................................. 39 4.2.1. Symbols on CSS Device Label ............................................................................................. 39 4.3. ECH External Communications Hub Device Label .................................................................. 40 4.4. DIS Dark Imaging Sheet Device Label ..................................................................................... 41 4.4.1. Symbols on DIS Label ......................................................................................................... 41 4.5. DIB Dark Imaging Box Device Label ........................................................................................ 43 4.5.1. Symbols on DIB Label ......................................................................................................... 43 4.6. CCD Contact Charging Device, Device Label ........................................................................... 45 4.6.1. Symbols on CCD Label ........................................................................................................ 45 4.7. PSC Protective Storage Cradle Device Label ........................................................................... 47 4.7.1. Symbols on PSC Device Label ............................................................................................. 47 5. Cleaning and Disinfection .................................................................................................................. 48 5.1. HFC Handheld Fluorescence Camera Cleaning and Sterilization ........................................... 51 5.1.1. Cleaning the HFC................................................................................................................. 51 5.2.1. Sterilizing the HFC............................................................................................................... 52 5.2. ECH External Communications Hub Cleaning and Disinfection ............................................. 54 5.2.1. Cleaning ECH ....................................................................................................................... 55 5.2.2. Disinfecting ECH.................................................................................................................. 55 5.3. Dark Imaging Box Cleaning and Disinfection ............................................................................. 56 5.3.1. Cleaning Dark Imaging Box ................................................................................................ 56 5.3.2. Disinfecting Dark Imaging Box ........................................................................................... 56 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 3 of 101 5.4. CCD Contact Charging Device Cleaning and Disinfection ....................................................... 57 5.4.1. Cleaning CCD ....................................................................................................................... 57 5.4.2. Disinfecting CCD ................................................................................................................. 58 5.5. PSC Protective Storage Cradle Cleaning and Sterilization...................................................... 58 5.5.1. Cleaning Protective Storage Cradle ................................................................................... 58 5.5.2. Sterilizing Protective Storage Cradle ................................................................................. 59 6. Operating the Handheld Fluorescence Camera, and Eagle V1.2 Imaging System Accessories ....... 60 6.2. HFC Handheld Fluorescence Imaging Device Overview and Operation ................................ 60 6.2.1. Tactile Interface .................................................................................................................. 60 6.2.2. Software User Interface ..................................................................................................... 64 6.3. Accessories Overview and Operation ........................................................................................ 77 6.3.1. Custom Sterile Sleeve (CSS) Instructions for Use .............................................................. 77 6.3.2. External Communications Hub (ECH) Instructions for Use ............................................... 87 6.3.3. DIS Dark Imaging Sheet ................................................................................................... 94 6.3.4. DIB Dark Imaging Box ...................................................................................................... 95 6.3.5. CCD Contact Charging Device .......................................................................................... 96 6.3.6. PSC Protective Storage Cradle......................................................................................... 98 7. Workflow ............................................................................................................................................ 99 7.1. Unpack ........................................................................................................................................ 99 7.2. Imaging Workflow ...................................................................................................................... 99 7.3. Post Imaging ............................................................................................................................... 99 8. Care and Maintenance ....................................................................................................................... 99 8.1. Transport and Handling.............................................................................................................. 99 9. Performance Specifications ............................................................................................................... 99 9.1. HFC Handheld Fluorescence Camera .......................................................................................... 99 9.2. CSS Custom Sterile Sleeve ......................................................................................................... 100 9.3. ECH External Communications Hub .......................................................................................... 100 9.3.1. ECH PC Power Supply ............................................................................................................... 100 9.3.2. ECH Router Power Supply ........................................................................................................ 100 9.3.3. DVI Link Power Supply ............................................................................................................. 100 9.3.4. ECH Router Wireless ................................................................................................................. 100 9.4. CCD Contact Charging Device .................................................................................................... 100 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 4 of 101 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 5 of 101 1. Introduction For use only by qualified investigators who have completed the Investigator Training Program in accordance with SBI-CIP 20-002, the Eagle V1.2 Imaging System is intended for performing intraoperative white light and Fluorescence Imaging of surgical cavities and excised tissues, including breast tissue obtained during breast cancer surgery. As sponsor of clinical trial SBI-CIP 20-002, SBI ALApharma Canada Inc. supports clinical trial sites and investigators in addition to providing the information in this Instructions for Use document and SBI-CIP-

20-002 Investigators Brochure. Read this document before using the Eagle V1.2 Imaging System, the Handheld Fluorescence Camera, or accessories. The primary component of the Eagle V1.2 Imaging System is the Handheld Fluorescence Camera (HFC); a battery operated, portable, and handheld optical imaging device intended for use in the operating room environment. Refer to Section 6.2 for full details. In study protocol SBI-CIP-20-002, Fluorescence Imaging of surgical cavities and excised tissues is specifically intended to be performed on patients who have consumed appropriate doses of the investigational drug PD G 506 A (aminolevulinic acid hydrochloride [ALA HCl] granules for oral solution). Aminolevulinic acid (ALA) a non-fluorescent non-protein amino acid that is converted into the fluorophore protoporphyrin IX (PpIX) as part of the heme biosynthesis pathway. The Eagle V1.2 Imaging Systems fluorescent excitation blue-violet light (405 nm) is maximally absorbed by PpIX fluorophores accumulated in malignant tissues. The resulting red fluorescence emission (600 660 nm) from PpIX in malignant tissues and green fluorescence emission (500 545 nm) from connective tissues and stroma are displayed in real time on the Handheld Fluorescence Cameras display screen. The HFC, Handheld Fluorescence Camera, operates with a number of accessories to ensure specified performance and safety during use:

i. CSS Custom Sterile Sleeve o A sterile sheath to entirely cover the Handheld Fluorescence Camera during use within the sterile field of an operating room (OR). Refer to Section 2.2.1 and Section 6.3.1 for full details. ii. ECH External Communication Hub o Mirrors the Handheld Fluorescence Cameras display on to the display monitor and facilitates the transfer/export of saved data on the Handheld Fluorescence Camera. Refer to Section 2.2.2 and Section 6.3.2 for full details. iii. DIS Dark Imaging Sheet o A non-fluorescent plastic sheet providing a consistent and standardized surface background for Fluorescence Imaging of excised tissues inside the Dark Imaging Box. Refer to Section 2.2.3 and Section 6.3.3 for full details. iv. DIB Dark Imaging Box o A mechanical assembly providing the optimal dark environment needed to perform Fluorescence Imaging of excised tissue. Refer to Section 2.2.4 and Section 6.3.4 for full details. v. CCD Contact Charging Device PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 6 of 101 o A charging cradle for the Handheld Fluorescence Camera, providing a secure, flat surface for the HFC to rest while charging. Refer to Section 2.2.5 and Section 6.3.5 for full details. vi. PSC Protective Storage Cradle o A reusable stand to securely store and protect the Handheld Fluorescence Camera when not in use. Refer to 2.2.6 and Section 6.3.6 for full details. 1.1. Intended Use/Indications for use Eagle V1.2 Imaging System The Eagle Imaging System is intended for capturing and viewing white light and fluorescence images and videos produced with conventional white light illumination, and excitation light at 405nm and emission light at 500-545 nm and 600-660 nm, respectively. The Eagle Imaging System is indicated for use in imaging a surgical cavity or excised human tissue specimens, including breast tissue specimens obtained during breast cancer surgery, and can be used in patients that have received fluorescent imaging contrast agents with the appropriate optical characteristics. 1.2. Intended Use/indication for use PD G 506 A PD G 506 A as an optical imaging agent for real-time visualization of malignant tissue during breast conserving surgery (lumpectomy, partial mastectomy) for breast cancer. 1.3. Clinical Need Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the primary malignancy while conserving as much of the surrounding normal tissue as possible. Currently, surgeons rely on a multitude of methods to assess the adequacy of tissue margins intra-

operatively including visual assessment and palpation, specimen radiology, intraoperative ultrasound and intraoperative histopathology. There is no consensus on intraoperative resection adequacy and definitive margin assessment requires histopathological assessment, which is not real-time or practical in the intra-

operative setting. Despite intra-operative measures to obtain clean margins in BCS, the need for re-

excision via a subsequent surgery is not uncommon. Re-excisions increase poor cosmesis, complications, discomfort, stress, adjuvant delay, medical costs and risk of local recurrence. Re-excisions due to final positive margins also increase the risk of disease local recurrence and decrease disease-specific survival. Optimizing surgery to improve resection guidance and positive margin assessment during initial BCS would be highly impactful, leading to a decreased need for subsequent surgeries. In a number of clinical trials, ALA a non-fluorescent non-protein amino acid that is converted into the fluorophore protoporphyrin IX (PpIX) as part of the heme biosynthesis pathway and preferentially accumulates in malignant tissue has been administered orally for the purpose of fluorescence-based imaging of a variety of other cancer types such as rectal carcinomas, malignant gliomas, and palpable breast tumours. Optimizing surgery with the use of ALA and an appropriate Fluorescence Imaging device to improve resection guidance and positive margin assessment during initial BCS would be highly impactful, leading to a decreased need for subsequent surgeries. 1.4. Principles of Operation The inability to differentiate tissues of interest during surgical procedures represents a challenge for surgeons. For example, during surgical resection of solid tumors, visualization of cancer in the resected PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 7 of 101 tissue specimens and surgical cavity, beyond what can be visualized based on conventional surgical and imaging approaches, would provide surgeons with clinically useful real-time information. In patients undergoing breast conserving surgery, the presence of cancer in the margin of the resected lumpectomy and/or in the surgical cavity that is undetected by standard of care is a significant clinical challenge for surgeons and pathologists, and a risk to patients. The Eagle V1.2 Imaging System, when used in combination a cancer-specific contrast agent, can address these challenges by enabling real-time fluorescence visualization of otherwise occult cancerous tissue. Using blue-violet light excitation (405 nm), the Eagle V1.2 Imaging System can visualize protoporphyrin IX

(PpIX) fluorescence emitted by cancer cells in patients who have received aminolevulinic acid (ALA), a non-fluorescent prodrug contrast agent, prior to surgery [1]. Metabolism of ALA in the body leads to the selective accumulation of PpIX in cancer cells. Under the blue-violet excitation light emitted by the Eagle V1.2 Imaging System, the red PpIX fluorescence from cancer cells is detected simultaneously against background normal tissues (which do not produce significant levels of PpIX) autofluorescence thereby producing a composite fluorescence image (or video) in which PpIX fluorescent cancer cells and tissues appear red in color in contrast to healthy surrounding tissues comprised primarily of connective tissue, which appear predominantly green in color; noting that adipose tissue can appear dull-brown in color in fluorescence images of breast tissues. 1.4.1. ALA and Protoporphyrin (PpIX) Production The ALA-induced accumulation of PpIX in cancer cells is what enables the Eagle V1.2 Imaging System to visualize malignant tissues. The following section describes PpIX synthesis in malignant and healthy tissues and how exogenous administration of ALA leads to selective accumulation of PpIX in cancer cells thereby producing fluorescence contrast between cancer cells and surrounding healthy tissues using the Eagle V1.2 Imaging System. ALA is a naturally occurring, endogenous substance, which belongs to the group of sensitizers used in photodynamic diagnosis. It is the first compound in the heme synthesis pathway. Heme biosynthesis begins within the mitochondrion, where ALA synthase catalyzes the condensation of succinyl-CoA and glycine to form ALA. Aminolevulinic acid dehydratase (ALAD) condenses 2 molecules of ALA to form the monopyrrole PBG. PBG deaminase catalyzes the polymerization of 4 molecules of PBG to hydroxymethylbilane. Hydroxymethylbilane is further metabolized to uroporphyrinogen I and III (by uroporphyrinogen cosynthase). Uroporphyrinogen decarboxylase sequentially removes a carboxylic group from the acetic side chains of each of the pyrrole rings to yield coproporphyrinogen. Coproporphyrinogen oxidase removes a carboxyl group from the propionic groups on 2 of the pyrrole rings to yield protoporphyrinogen IX. Protoporphyrinogen oxidase forms PpIX by removing 6 hydrogen atoms from protoporphyrinogen IX. Finally, ferrochelatase mediates the insertion of ferrous iron into the porphyrin macrocycle, forming heme. Heme biosynthesis is regulated by a negative feedback loop in which ALA synthase mitochondrial transport is inhibited by heme. Administration of excess exogenous ALA avoids the negative feedback control, and accumulation of PpIX occurs in target tissue. Coproporphyrinogen oxidase removes a carboxyl group from the propionic groups on 2 of the pyrrole rings to yield protoporphyrinogen IX. Protoporphyrinogen oxidase forms PpIX by removing 6 hydrogen atoms from protoporphyrinogen IX. Finally, ferrochelatase mediates the insertion of ferrous iron into the porphyrin macrocycle, forming heme. Heme biosynthesis is regulated by a negative feedback loop in which ALA synthase mitochondrial transport is inhibited by heme. Administration of excess exogenous ALA avoids the negative feedback control, and accumulation of PpIX occurs in target tissue. ALA HCl for oral solution is usually administered 3 hours (range 2 to 4 hours) before anesthesia prior to surgery. The investigational drug PD G 506 A is 1.5 g ALA hydrochloride (HCl) granules (chemical name: 5-

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 8 of 101 amino-4-oxo-pentanoic acid hydrochloride) for oral solution. When reconstituted in water, it can be administered exogenously to overload the cellular porphyrin metabolism and generate a build-up of PpIX. When ALA HCl is administered exogenously by oral route, the abundantly produced red fluorescent PpIX cannot be quickly converted to its final product, heme, by the enzyme ferrochelatase and therefore accumulates in cells. PpIX accumulates in cancer cells to a higher extent than in healthy cells. This is primarily attributed to differences in the overall metabolic activity, increased ALA uptake, and a relative deficiency in activity of ferrochelatase and other heme biosynthesis enzymes in cancer cells. The preferential and selective accumulation of PpIX in cancer cells, relative to healthy cells, provides an opportunity to visualize PpIX fluorescence in cancer cells in real-time during breast cancer surgery (Figure 1). Figure 1 Principles of Fluorescence 1.4.2. Fluorescence Imaging The Eagle V1.2 Imaging System is a handheld intraoperative white light and Fluorescence Imaging device and accessories intended to be used during surgical procedures. Fluorescence imaging is a type of optical imaging technique used to visualize and document biological processes or structures. Fluorescence imaging relies on exogenous or endogenous fluorophores, molecules that emit light of a longer wavelength when exposed to light of a different (shorter) wavelength. When a fluorophore absorbs light, the energy of the molecule is briefly raised to higher excited states. The subsequent return to the ground state results in the emission of fluorescent light. The emitted fluorescent light, resulting from the absorbed photon of energy has a specific wavelength and can be detected and measured. Typically, Fluorescence Imaging is performed using steady-state fluorescence, where fluorophores are excited by a constant source of light, emit fluorescence, and the emitted fluorescent photons, or intensity, are detected as a function of wavelength. The Eagle V1.2 Imaging System uses steady-state Fluorescence Imaging. The main components a Fluorescence Imaging system are the following:

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 9 of 101 The main components a Fluorescence Imaging system are the following:

1. Fluorophores: Fluorescent molecules that can re-emit light upon light excitation. 2. Excitation source: Illumination source with a specific wavelength of light which is absorbed by the fluorophores, exciting the molecules and resulting in the emission of light at a longer wavelength. Emitted fluorescence can span ultraviolet, visible light, near-infrared light and infrared and beyond. 3. Optical filter(s): Restricts the amount of reflected and scattered excitation light, emitted fluorescent light and ambient light reaching the detector as well as the amount of excitation light reaching the imaging target during Fluorescence Imaging. 4. Detector: An instrument or sensor that detects and conveys (optical) information used to make an image. 5. Display: An output device that translates captured information and presents in a visual form. 1.4.2.1. Eagle V1.2 Fluorescence Imaging System The following diagram (Figure 2) depicts the system architecture of the Eagle V1.2 Fluorescence Imaging System. Figure 2 Eagle V1.2 Imaging System PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 10 of 101 1.4.2.2. Fluorophores Protoporphyrin IX (PpIX) and Connective Tissue PpIX is a fluorophore that accumulates in cancer cells when a supply of exogenous ALA is supplied. When excited by 405 nm, PpIX emits red fluorescent light with a peak wavelength of approximately 635 nm. This red fluorescence can be used to visualize and locate the presence of PpIX fluorescent cancerous tissue. See (Figure 11). In addition, tissue autofluorescence is also emitted under 405 nm excitation. tissue, autofluorescence is typically green in color, largely attributed to autofluorescence of connective tissues and redox cofactors such as nicotinamide adenine dinucleotide (NADH) and flavin adenine dinucleotide (FAD). The Eagle V1.2 Imaging System captures both the background green tissue autofluorescence and the PpIX red fluorescence simultaneously and in real-time. In breast Figure 3 PpIX Excitation and Emission 1.4.2.3. Excitation Source 405 nm Illumination PpIX has maximum light absorption from blue-violet light at 405 nm (Figure 12). The Eagle V1.2 Imaging System utilizes safe blue-violet (peak: 405-410 nm) emitting LEDs and an excitation filter to emit narrow wavelength band centered around 405 nm to induce maximum PpIX fluorescence as well as background tissue autofluorescence (Figure 4). Figure 4 Excitation Light PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 11 of 101 1.4.2.4. Optical Filters Dual Bandpass Filter In order to effectively visualize and image PpIX fluorescence, the 405 nm excitation light must be blocked from the imaging sensor. To accomplish this, a custom dual bandpass emission filter is placed in front of the camera image sensor thus preventing reflected or backscattered excitation light as well ambient room lighting from entering the image sensor. The two wavelength bands of fluorescence emission transmitted to the devices imaging sensor are green (500 545 nm) and red (600 660 nm) (Figure 5). Figure 5 Dual Bandpass Filter First, the red bandpass region is for visualizing the red fluorescence emitted from fluorophores such as PpIX. Second, the green bandpass region is for visualizing green autofluorescence emitted from components of healthy tissue such as collagen and elastin in connective tissue and redox cofactors NADH and FAD. The addition of the green fluorescence channel is to (visually) contrast and accentuate the red fluorescence produced by the accumulation of PpIX in cancerous cells and differentiate the PpIX fluorescent cells from healthy tissue, seen as green, in real-time. 1.4.2.5. Detector C-MOS Camera Sensor Once fluorescence is induced, an image sensor is required to detect this light information from the fluorescence source and generate an image for real-time visualization and documentation. The Eagle V1.2 Imaging System utilises a C-MOS (Complementary Metal Oxide Semiconductor) sensor as a detector. 1.4.2.6. Display Finally, colour display screens present all the captured fluorescence information in a real-time visual form to the user e.g. images or video. The Eagle V1.2 Imaging System uses two forms of display, a colour active matrix organic light emitting diode (AMOLED) display on the Handheld Fluorescence Camera (HFC) and an external colour liquid crystal display (LCD) monitor, which is larger for viewing by multiple members of the surgical team. 1.1. Regulatory Information PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 12 of 101 The Eagle V1.2 Imaging System has received the following authorizations in order to conduct clinical trial SBI-CIP-20-002 in accordance with applicable United States and Canadian regulatory requirements per FDA and Health Canada:

Investigational Product Drug Product:

PD G 506 A Table 1 Investigational Authorizations USA Canada In accordance with 21 CFR PART 312 INVESTIGATIONAL NEW DRUG APPLICATION, an IND was submitted to the FDA to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002 In accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications a CTA was submitted to Health Canada to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002 Imaging Device:

Eagle V1.2 Imaging System In accordance with 21 CFR PART 812 INVESTIGATIONAL DEVICE EXEMPTIONS, an IDE is not required to approve Eagle V1.2 Imaging System for use in clinical trial SBI-CIP 20-002 In accordance with Guidance Document Applications for Medical Device Investigational Testing Authorizations an ITA was submitted to Health Canada to approve Eagle V1.2 Imaging System use in clinical trial SBI-CIP 20-002 1.2. Terminology Used Table 2 Terminology Used Term / Acronym Definition / Meaning EtO Tx Rx ALA P/N GB Type-C Cm EtO Sterilization is a low-temperature process that uses Ethylene Oxide gas to reduce the level of infectious agents. Transmit Receive aminolevulinic acid Part Number Gigabyte USB-C (formally known as USB Type-C) is a 24-pin USB connector system with a rotationally symmetrical connector centimeter PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 13 of 101 2. Eagle V1.2 Imaging System Contents Table 3 Eagle V1.2 Imaging System Component Depiction Part Number (P/N) HCF Handheld Fluorescence Camera CSS Custom Sterile Sleeve ECH External Communication Hub P/N 10055 Refer to Section 2.1 and Section 6.2 for full details. P/N 10180 Refer to Section 2.2.1 and Section 6.3.1 for full details. P/N 10206 Refer to Section 2.2.2 and Section 6.3.2 for full details. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 14 of 101 Table 3 Eagle V1.2 Imaging System Component Depiction Part Number (P/N) DIS Dark Imaging Sheet DIB Dark Imaging Box CCD Contact Charging Device P/N 10171 Refer to Section 2.2.3 and Section 6.3.3 for full details. P/N 10117 Refer to Section 2.2.4 and Section 6.3.4 for full details. P/N 10066 Refer to Section 2.2.5 and Section 6.3.5 for full details. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 15 of 101 Table 3 Eagle V1.2 Imaging System Component Depiction Part Number (P/N) PSC Protective Storage Cradle P/N 10095 Refer to Section 2.2.6 and Section 6.3.6 for full details. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 16 of 101 2.1. HCF Handheld Fluorescence Camera The Handheld Fluorescence Camera (HFC) is the primary element of the Eagle V1.2 Imaging System. The HFC is a portable, handheld and battery-

operated imaging device, equipped with an AMOLED color display screen, and an optical head integrated with excitation and emissions optics to enter and image the surgical cavity. Optical Head Power Button The optical head contains an ambient light sensor to detect ambient lighting conditions described in 6.2.2.2.5.1, and a range finder to detect imaging range as described in section 6.2.2.2.2. Camera

/ Video Capture Buttons Display Screen Located in the center above the display screen, the HFC has a single power button to turn the device on, and to sleep or wake the display screen once powered on. Refer to section 6.2.1.1 for full details. WL/FL Buttons Located on the left of the display screen, the HFC has a camera button, used to capture and save images and videos respectively. Refer to section 6.2.1 for full details. and video Figure 6 Handheld Fluorescence Camera HFC Located on the right of the display screen, the HFC has White Light buttons, to enable white light LEDS for White Light Imaging or blue-violet LEDS for Fluorescence imaging, respectively. For full details refer to section 6.2.2.2.4 for White Light Imaging and section 6.2.2.2.5 for Fluorescence Imaging. and Fluorescence The HFC lithium ion battery is rechargeable using the Contact Charging Device (CCD) described in Section 2.2.5 and Section 6.3.5. 2.1.1. HFC Optical Head The HFC optical head shown in Figure 7 integrates two camera sensors, one dedicated for White Light Imaging and one dedicated for Fluorescence Imaging. During White Light Imaging described in section 6.2.2.2.4, two white light LEDs illuminate the field of view. During Fluorescence Imaging described in section 6.2.2.2.5, four blue-violet light LEDs illuminate the field of view. 2.1.1.1. Emissions Filter A custom infrared emission filter (95% Transmission of wavelengths 420 700 nm and 815 900 nm and blocking all other NIR light >700nm) placed in front of the white light camera sensor ensures only light in the visible spectrum is captured. A custom optical emission filter (>95% transmission of wavelengths 500 545 nm and 600 665 nm and blocking NIR light >700nm) placed in front of the fluorescence camera ensures only the resulting red fluorescence emission from PpIX in malignant tissues, and green fluorescence emission from connective tissues and stroma are captured. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 17 of 101 2.1.1.2. Range Finder The Range Finder positioned in the center of the optical head measures the distance of the optical head from the imaging target. The software user interface controlled by the HFC Display Screen (Section 6.2.1) instructs the operator to move closer or move away from the imaging target to achieve optimal imaging ranges. Refer to section 6.2.2.2.1 for full details on the Range Finder. 2.1.1.3. Ambient Light Sensor The Ambient Light Sensor positioned in the bottom left corner of the HFC Optical Head measures the ambient light level in the imaging environment. The software user interface (Section 6.2.2) controlled by HFC Display Screen (Section 6.2.1) instructs the operator when correct ambient lighting conditions are achieved for Fluorescence Imaging (Section 6.2.2.2.5). Refer to Section 6.2.2.2.5.1 for full details on the Ambient Light Sensor. 2.1.1.4. Temperature Sensor The temperature sensor continually monitors the temperature of the optical head, ensuring the HFC does not overheat and its operating parameters continually remain in tolerance. During imaging (Section 6.2.2.2) the Software User Interface (Section 6.2.2) controlled by the HFC Display Screen (Section 6.2.1) displays a temperature gauge to communicate device temperature to the operator. Refer to section 6.2.2.2.1 for full details on the temperature gauge. Figure 7 HFC Optical Head PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 18 of 101 2.2. Accessories and Consumables 2.2.1. CSS Custom Sterile Sleeve The Custom Sterile Sleeve is a single use, ethylene-oxide (EtO) sterilized sheath to entirely cover the Handheld Fluorescence Camera while imaging surgical cavities. Refer to Section 6.3.1 for CSS Instructions for Use. Table 4 CSS Features The single use CSS is made from a clear, biocompatible plastic material that has been sterilized using EtO. 1. The CSS is shaped to contour the Handheld Fluorescence Camera. 2. The portion of the CSS fitting over the HFC optical head is equipped with an optical window ensuring the optical head is protected during imaging while maintaining the HFC optical performance parameters. The CSS is designed to accommodate ECH wired configuration or ECH wireless configuration. When ECH wired configuration is used (see Section 6.3.2.3), the HFC USB Cable is sheathed using the CSS 6-foot-long telescopic HFC USB Cable Cover. 3. When ECH wireless configuration is used (see Section 6.3.2.2), the telescopic-folded HFC USB Cable Cover is secured by the CSS Tape. 4. The CSS Tape is exposed by removing its adhesive backing with the pull tab, and laid across the sheathed HFC to seal and close the CSS

(see Section 6.3.1). PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 19 of 101 Table 4 CSS Features 5. Each CSS is accompanied by 2 small sterile bags to handle the HFC USB Hatch with sterile technique (see Section 6.3.1) while establishing ECH wireless configuration (Section 6.3.2.2) or ECH wired configuration (Section 6.3.2.3). 6. Each CSS is accompanied by 3 pieces of tape. Tape is used to secure the sterile bag around the HFC USB Cable for ECH Wireless Configuration (see Section 6.3.2.2), and to secure the HFC USB Cable for both ECH Wireless and Wired Configuration

(see Section 6.3.2.3). 7. Refer to Section 4.2 for details on the CSS device label. 8. The CSS is a single use device. The CSS cannot be re-sterilized. 2.2.2. ECH External Communication Hub Intended to cast the Handheld Fluorescence Cameras display through a wired or wireless connection on to the ECH Display monitor, the External Communication Hub (ECH) is comprised of 2. ECH PC A Small Form Factor Computer with encrypted USB Flash Drive (32 Gb) and Numeric 1. ECH Display Monitor Pad 3. ECH Router 4. ECH DVI Link Assembly, and ECH USB Cable 5. ECH Power Supplies and Extension Cables 6. ECH Power Bar 7. Cart (ECH Cart) The External Communication Hub also facilitates the transfer/export of saved images from the Handheld Fluorescence Camera to external media. Refer to Section 6.3.2 for ECH Instructions for Use. Table 5 ECH Features 1. The ECH Display Monitor casts the Handheld Fluorescence Cameras display. 2. The ECH PC facilitates HFC display casting and saving data stored on the HFC as a backup. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 20 of 101 Table 5 ECH Features 3. The ECH backs up all captured images and videos from the HFC onto the encrypted USB flash drive. 4. The ECH Numeric Pad allows the operator to enter a PIN to login and setup the ECH. 5. When connected to the ECH PC using an ethernet cable, the ECH Router allows HFC display casting wirelessly. Refer to Section 6.3.2.1 for details on ECH Wireless Configuration. The ECH DVI Link Assembly sends HFC imaging data received by the ECH PC to the ECH Display Monitor. The ECH DVI Link Assembly is comprised of 6. DVI Link Transmitter

(Tx) DVI Link Receiver (Rx) Tx Power Supply Rx Power Supply Optical Cable DVI to HDMI Cable 7. The HFC USB Cable with ECH Link Cable connects the HFC to the ECH PC for ECH Wired Connection. See Section 6.3.2.3 for details on ECH Wired Connection. To establish the ECH Wireless Configuration per Section 6.3.2.2, the HFC USB Cable is connected to the ECH PC provisionally. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 21 of 101 Table 5 ECH Features A maximum of 5 power supplies connect to the ECH Power Bar:

8. 1) ECH Display Monitor 2) ECH PC 3) ECH DVI Link Rx 4) ECH DVI Link Tx 5) ECH Router 9. The ECH portable Cart holds and secures all ECH components and is accompanied by a 15-foot-

long Hospital Medical Power Extension Cord. 10. Refer to Section 4.3 for details on the ECH device label. 11. The ECH can be cleaned and disinfected with Intermediate Level Disinfection wipes in accordance with Section 5.2. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 22 of 101 2.2.3. DIS Dark Imaging Sheet The DIS is a single use, ethylene-oxide (EtO) sterilized non-fluorescent plastic sheet providing a consistent and standardized surface background for Fluorescence Imaging of excised tissues in the sterile field, or inside the Dark Imaging Box (Section 2.2.4 and Section 6.3.4). Refer to Section 6.3.3 for DIS Instructions for Use. Table 6 DIS Features 1. The DIS measures 10.5 (inches) long by 8.3 (inches) wide. 2. The rigid DIS is made from a black non-

reflective, non-fluorescent, non-absorbent material to prevent artifacts and provide a consistent and standardized surface background for Fluorescence Imaging. The durable non-creasing material prevents contamination of specimens placed on it. 3. The bottom of the DIS is labeled with This Side Down / Ce Ct En Bas to indicate that the bottom of the DIS is not intended for placing specimen. 4. The DIS can be used alone in the sterile field, or together inside the Dark Imaging Box per Section 6.3.4. 5. Refer to Section 4.4 for details on the DIS device label. 6. The DIS is a single use device. The DIS cannot be re-sterilized. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 23 of 101 2.2.4. DIB Dark Imaging Box The Dark Imaging Box (DIB) is designed to cradle the Handheld Fluorescent Camera in a fixed position providing controlled and consistent conditions for imaging tissue specimens. The Dark Imaging Sheet is required to be placed on the Dark Imaging Box Tray per 6.3.3. Refer to Section 6.3.4 for DIB Instructions for Use. Table 7 DIB Features 1. Made from stainless steel and aluminium, the Dark Imaging Box has a wide base to stabilize the platform during imaging. 2. The DIB Cradle at the top of the Dark Imaging Box secures the Handheld Fluorecent Camera in ECH Wireless (Section 6.3.2.2) or ECH Wired configuration (Section 6.3.2.3). PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 24 of 101 Table 7 DIB Features 3. Using the DIB Wheel, the DIB Imaging Platform is vertically adjustable to achieve correct imaging ranges as guided by the Range Finder per Section 6.2.2.2.2. The DIB ruler indicates the distance in cm (centimeters) between the tip of the HFC Optical Head and the DIB Imaging Platform. 4. The DIB Tray is a sliding removeable tray for easy handling and orientation of imaging specimen, designed with a recess to secure the Dark Imaging Sheet into position per Section 6.3.3. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 25 of 101 Table 7 DIB Features The single use disposable DIB Covers enclose the specimen for a controlled and consistent imaging environment. 5. Magnets embeddded around the top and bottom of the DIB align with the metal tabs on the DIB Covers to lock them in place. 6. Refer to Section 4.5 for details on the DIB device label. 7. The DIB can be cleaned and disinfected with Intermediate Level Disinfection wipes in accordance with Section 5.3. 2.2.5. CCD Contact Charging Device The Contact Charging Device (CCD) is a charging cradle for the Handheld Fluorescence Camera, providing a secure surface for the HFC to rest while charging. Refer to Section 6.3.5 for CCD Instructions for Use. Table 8 Contact Charging Device Features 1. The Contact Charging Device is powered by the CCD Power Supply, a USB Type-C power supply plugged into the back side of the CCD. When plugged into the USB Type-C power supply, the front side of the Contact Charging Device has a white LED that illuminates. 2. Two (2) charging pins on the top side of the CCD mate with the HFC. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 26 of 101 Table 8 Contact Charging Device Features The HFC is charged by placing it in the Contact Charging Device. The retainer guard on the back side of the CCD secures the HFC while charging. 3. The HFC battery begins charging when the HFC makes contact with the two charging pins on the top side of the CCD. 4. The bottom side of the Contact Charging Device has 6 anti-slip rubber feet to ensure it sits securely on a flat surface positioned in the non-sterile area of the imaging environment. 5. Refer to Section 4.6 for details on the CCD device label. 6. The CCD can be cleaned and disinfected with Intermediate Level Disinfection wipes in accordance with Section 5.3. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 27 of 101 2.2.6. PSC Protective Storage Cradle The Protective Storage Cradle is designed to Safeguard the Handheld Fluorescence Camera and optical head when not in use (including during a surgical procedure) or during transportation. Refer to Section 6.3.6 for PSC Instructions for Use. Table 9 Protective Storage Cradle Features Made from stainless steel and acetal, the PSC has a cradle to rest the body of the HFC, a protective shaft to safeguard the HFC optical head, and a lock to secure the HFC once in position. 1. 2. Refer to Section 4.7 for details on the PSC device label. 3. The PSC can be cleaned and steam sterilized in accordance with Section 5.5. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 28 of 101 3. Safety Information This section is intended to provide users with safety information in order to operate the device safely and as intended. 3.1. Certifications 3.1.1. HFC Handheld Fluorescence Camera ISO 10993-1:2018 Evaluation of Medical Devices Part 1: Evaluation of and Testing Within a Risk Management Plan ISO 17664:2017 Processing of Health Care Products Information to be Provided by the Medical Device Manufacturer for the processing of Medical Devices IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-6:2010 Medical Electrical Equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability IEC 62366-1:2015 Medical Devices Part 1: Application of Usability Engineering to Medical Devices IEC 60601-2-18:2019 Medical Electrical Equipment Part 2-18: Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Disturbances Requirements and Tests IEC 62471 Photobiological Safety of Lamps and Lamp Systems IEC 62133-2 Secondary Cells and batteries containing alkaline or other non-acid electrolytes: Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems 3.1.2. CSS Custom Sterile Sleeve ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 11135:2014 Sterilization of Health Care Products -Ethylene Oxide Requirements for the development, validation and routine control of a sterilization process for medical devices 3.1.3. ECH External Communications Hub ISO 17664:2017 Processing of Health Care Products Information to be Provided by the Medical Device Manufacturer for the processing of Medical Devices PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 29 of 101 IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Disturbances Requirements and Tests 3.1.4. DIS Dark Imaging Sheet ISO 11135:2014 Sterilization of Health Care Products -Ethylene Oxide Requirements for the development, validation and routine control of a sterilization process for medical devices 3.1.5. DIB Dark Imaging Box Not Applicable. 3.1.6. CCD Contact Charging Device IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Disturbances Requirements and Tests 3.1.7. PSC Protective Storage Cradle ISO 17664:2017 Processing of Health Care Products Information to be Provided by the Medical Device Manufacturer for the processing of Medical Devices ISO 17665-1:2006 Sterilization of Health Care Products Moist Heat Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices 3.2. Classification In accordance with 21 CFR PART 312 INVESTIGATIONAL NEW DRUG APPLICATION, an IND was submitted to the FDA to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002. In accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications a CTA was submitted to Health Canada to approve PD G 506 A drug use in clinical trial SBI-CIP 20-002. In accordance with Guidance Document Applications for Medical Device Investigational Testing Authorizations an ITA was submitted to Health Canada to approve Eagle V1.2 Imaging System use in clinical trial SBI-CIP 20-002. The Handheld Fluorescence Camera is intended for use only by qualified investigators in accordance with SBI-CIP-20-002. The Handheld Fluorescence Camera is classified as IP67 for fluid ingress, and has protection against exposure to liquids. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 30 of 101 The Eagle V1.2 Imaging System complies with Part 15 of the FCC Rules (USA) and ICES-3(B)/NMB-3(B)

(Canada). Handheld Fluorescence Camera has an operational duty cycle of 5 minutes on, 15 minutes off. 3.2.1. Federal Communication Interference Statement We SBI ALApharma, 305-123 Edward St, Toronto, ON, M5G 1E2, Canada, 289-800-9455, declare under our sole responsibility that the Handheld Fluorescence Camera complies with complies with Part 15 Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This product does not contain any user serviceable components. Any unauthorized product changes or modifications will invalidate warranty and all applicable regulatory certification and approvals, including authority to operate this device. WARNING: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and radiates radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. 3.2.2. Industry Canada Statements This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause interference, and (2) This device must accept any interference, including interference that may cause undesired operation the device. Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes: (1) lappareil ne doit pas produire de brouillage, et (2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. 3.2.3. Electromagnetic Compatibility The Handheld Fluorescence Camera meets the requirements of Safety EMC Testing per IEC 60601-1-

2:2014 4th Edition / EN 60601-1-2:2015. Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be used according to the instructions in this User Manual. While unlikely, it is possible that high levels of emitted radio-frequency (RF) electromagnetic interference

(EMI) from other portable and mobile RF communications equipment or nearby radio-frequency sources could result in performance disruption of the Handheld Fluorescence Camera. Warning The device is equipped with sensitive electronic components. While imaging, avoid strong electrical or electromagnetic fields, e.g. mobile phones, microwave ovens, etc.; or it may lead to temporary imaging error or inaccuracy. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 31 of 101 To avoid the risk of increased electromagnetic emissions or decreased immunity from such emissions, use only accessories, including power cables, recommended by SBI ALApharma Canada Inc. Connection of accessories not recommended by SBI ALApharma Canada Inc. will void product warranty and could result in malfunctioning of the HFC or other devices located in the area. Additionally, user of the HFC can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HFC as recommended in Section 10. Some RF emitters (e.g. RFID) in the intended environment of use might be concealed. The device could potentially be exposed to fields from these RF emitters without user awareness. Take the following precautions to prevent electromagnetic interference:

Caution Maintain a minimum distance between portable and mobile RF communications equipment (transmitters) and the HFC as recommended in Section 10. Move to a different environment to image if experiencing imaging artifacts, such as noise or distortion of the image Note The emissions characteristics of the HFC make it suitable for use in industrial areas and hospitals (CISPR 11 class A). The HFC is not intended for use in a residential environment and does not comply with IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. If you experience imaging artifacts, such as noise or distortion of the image, move to a different environment to image. If problems persist contact SBI ALApharma Canada Inc. to troubleshoot the problem. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the ME SYSTEM The Handheld Fluorescence Camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Handheld Fluorescence Camera can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Handheld Fluorescence Camera as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz W 0.01 0.1 1 10 100

=1.2 0.12 0.38 1.2 3.8 12 m

=1.2 0.12 0.38 1.2 3.8 12

=2.3 0.24 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structure, objects and people. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 32 of 101 3.2.4. Radiation Output The Handheld Fluorescence Camera uses a miniature pulsed laser-based range finder to determine the correct distance between the device and wound for superior image quality. The laser module in the range finder emits light at 850 nm which is invisible to the human eye. The lasers individual pulse duration is 3.33 ns and the pulse train is 52.3 ms at a 200 ms repetition rate. The laser complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No.50. The laser is a Class 1 certified laser Caution Do not point the laser (from the Range Finder sensor) into eyes 3.3. Warning, Cautions, and Notes Warnings, cautions, and notes are used to describe serious and non-serious safety conditions of the device. The symbols used to describe these safety conditions are:

Warning Messages with this heading provide information and actions to take in order to prevent Eagle V1.2 Imaging System safety hazards. Caution Messages with this heading provide information and actions to take in order to operate Eagle V1.2 Imaging System correctly and prevent misuse. Warnings Cautions Notes Note Messages with this heading provide information and actions to take in order to increase the users understanding of Eagle V1.2 Imaging System correctly. 3.3.1. General Warnings Warning Description Always observe device labelling which includes this document and device labels. Refer to section 4 for information on all device labels. Do not use accessories or cables other than those specified in this Instructions for Use. Using unspecified accessories or cables may result in increased emissions or decreased immunity of the Handheld Fluorescence Camera. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 33 of 101 Warning Description Do not connect the Handheld Fluorescence Camera to a power supply using cables that have not been approved by SBI ALApharma Canada Inc. Do not attempt to open, modify, or disassemble the Handheld Fluorescence Camera which is ready for use once unpacked and charged. Do not charge or use the Handheld Fluorescence Camera in areas with potentially explosive atmospheres such as fueling areas or in areas where the air contains flammable or explosive chemicals or particles. Do not operate the Handheld Fluorescence Camera in oxygen-rich environments. Avoid exposing the Handheld Fluorescence Camera to magnetic fields, electrostatic discharge and thermal ignition sources during use. Do not point the illumination LEDs directly into eyes. Do not drop the Handheld Fluorescence Camera or subject the HFC to high force impact or shock. Protect the Handheld Fluorescence Camera by storing it in the Protective Storage Cradle, or in its original shipping package when not in use for prolonged periods of time. Be aware of surroundings to avoid trip or other hazards when operating the Handheld Fluorescence Camera in a dark environment Do not use the Handheld Fluorescence Camera or accessories without following appropriate cleaning, disinfection, and sterilization instructions in Section 5. Follow institutional procedures and processes for handling intraoperative medical equipment. Follow institutional procedures and processes for sterile technique. The safety and effectiveness of the Handheld Fluorescence Camera for diagnostic or treatment purposes has not been evaluated. Do not perform imaging outside of the Handheld Fluorescence Cameras Circle of Interest described in 6.2.2.2.3. Do not utilize image information outside of the Handheld Fluorescence Cameras Circle of Interest for image interpretation described in Section 6.2.2.2.5.2. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 34 of 101 Warning Description The Handheld Fluorescence Camera utilizes auto-exposure to optimize the exposure settings based on lighting conditions. Images captured on the HFC are relative, not quantitative, and may not represent absolute fluorescence levels. Avoid strong electrical or electromagnetic fields, e.g. mobile phones, microwave ovens, etc.;

which may result in temporary imaging error or inaccuracy. 3.3.2. General Cautions Caution Description Reflective objects (e.g. retractors or other metal objects) can produce red light reflections that can appear similar to PpIX Fluorescence. Sources of ambient light reflecting off of surfaces in the field of view may contaminate HFC images. Always verify ambient lighting conditions using the Ambient Light Sensor before performing Fluorescence Imaging. Always respect the Range Finder icons when performing Imaging. Do not operate the Handheld Fluorescence Camera using eyewear with color tint, polarization, or other factors which may distort the interpretation of colors on acquired images. The Handheld Fluorescence Camera should not be used by individuals confirmed to be color blind as the typical green and red color information comprising the acquired images may be misinterpreted. Ensure the optical head is clean prior to imaging. Acquired images may appear distorted, out of focus, or otherwise compromised if the optical head is not clean prior to imaging. Prior to charging the device, ensure the CFC Power Cable is undamaged before plugging into a wall outlet. Only use cables and power supplies provided by SBI ALApharma Canada Inc. with the Eagle V1.2 Imaging System. The optical head may get warm after prolonged use. The device will disable activated LEDs

(white light or blue-violet light) if device temperature exceeds 41C or 106F. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 35 of 101 Caution Description Some RF emitters (e.g. RFID) in the intended use environment may be concealed. The device could potentially be exposed to fields from these RF emitters without user awareness. Take the following precautions to prevent electromagnetic interference:

1. Maintain distance between portable and mobile RF communications equipment

(transmitters) and the Handheld Fluorescence Camera 2. Move to a different environment to image if experiencing imaging artifacts, such as noise or distortion of the image 3.3.3. General Note Note Description While charging, the device is inoperable with exception to reviewing acquired images and videos. The Handheld Fluorescence Camera is restricted for use exclusively by authorized healthcare professionals in accordance with SBI CIP 20-002. The Handheld Fluorescence Camera is solely intended for imaging surgical cavities and excised tissue. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 36 of 101 4. Labelling This section provides users with information on device and accessory labelling. 4.1. HFC Handheld Fluorescence Camera Device Label The following labels are applied to the HFC. 4.1.1. Symbols on HFC Device Label Table 10 Symbols on HFC Device Label Symbol Meaning Source Unique Device Identifier N/A Manufacturer Information ISO 7000 - 3082 Device Model Name N/A

1. 2. 3. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 37 of 101 Table 10 Symbols on HFC Device Label Symbol Meaning Source Reference Number ISO 7000 - 2493 Serial Number ISO 7000 - 2498 Date of Manufacture ISO 7000 - 2497 Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 N/A N/A N/A FCC ID ISED ID Warning for power cable use N/A Duty Cycle N/A WEEE Symbol. Dispose Electrical and Electronic Equipment. EN 50419 Non-ionizing electromagnetic radiation IEC 60417 - 5140 Consult the instructions for use ISO 7010 - M002 Caution ISO 7000 - 0434A

4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 38 of 101 4.2. CSS Custom Sterile Sleeve Device Label The following label is applied to the Custom Sterile Sleeve. 4.2.1. Symbols on CSS Device Label Table 11 Symbols on CSS Device Label Symbol Meaning Source Manufacturer Information ISO 7000 - 3082 Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 Device Model Name N/A N/A Reference Number ISO 7000 - 2493 Lot Number ISO 7000 - 2492

1. 2. 3. 4. 5. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 39 of 101 Table 11 Symbols on CSS Device Label Symbol Meaning Source

6. 7. 8. 9. 10. 11. 12. 14. 15. 13. Date of Manufacture ISO 7000 - 2497 Date of Expiry ISO 7000 - 2607 Indicating the product was EO Sterilized ISO 7000 - 2501 Indicating the product should not be used if the packaging has been damaged or opened ISO 7000 - 2606 The product is for single use only ISO 7000 - 1051 The product is not made with natural rubber latex ISO 15223-1 The product is not to be re-

sterilized ISO 7000 - 2608 The product is a type B Applied part IEC 60417 - 5840 Consult the instructions for use ISO 7010 - M002 Unique Device Identifier N/A 4.3. ECH External Communications Hub Device Label The ECH is a composition of several hardware components. Each hardware component described in Section 2.2.2 bears its own label. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 40 of 101 4.4. DIS Dark Imaging Sheet Device Label The following label is applied to the Dark Imaging Sheet. 4.4.1. Symbols on DIS Label Table 12 Symbols on DIS Label Symbol Meaning Source Manufacturer Information ISO 7000 - 3082 Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 Device Model Name N/A N/A Reference Number ISO 7000 - 2493 Lot Number ISO 7000 - 2492

1. 2. 3. 4. 5. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 41 of 101 Table 12 Symbols on DIS Label Symbol Meaning Source Date of Manufacture ISO 7000 - 2497 Date of Expiry ISO 7000 - 2607 Indicating the product was EO Sterilized ISO 7000 - 2501 Indicating the product should not be used if the packaging has been damaged or opened ISO 7000 - 2606 The product is for single use only ISO 7000 - 1051 The product is not made with natural rubber latex ISO 15223-1 The product is not to be re-

sterilized ISO 7000 - 2608 Consult the instructions for use ISO 7010 - M002

6. 7. 8. 9. 10. 11. 12. 13. 14. Unique Device Identifier N/A PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 42 of 101 4.5. DIB Dark Imaging Box Device Label The following label is applied to the Dark Imaging Box. 4.5.1. Symbols on DIB Label

1. Table 13 Symbols on DIB Label Symbol Meaning Source Manufacturer Information ISO 7000 - 3082 PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 43 of 101 Table 13 Symbols on DIB Label Symbol Meaning Source Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 Device Model Name N/A N/A Reference Number ISO 7000 - 2493 Serial Number ISO 7000 - 2498 Date of Manufacture ISO 7000 - 2497 Consult the instructions for use ISO 7000 - 1641 Unique Device Identifier N/A Product is Non-Sterile ISO 7000 - 2609

2. 3. 4. 5. 6. 7. 8. 9. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 44 of 101 4.6. CCD Contact Charging Device, Device Label The following label is applied to the Contact Charging Device. 4.6.1. Symbols on CCD Label Table 14 Symbols on CCD Label Symbol Meaning Source Manufacturer Information ISO 7000 - 3082 Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 Device Model Name N/A N/A Reference Number ISO 7000 - 2493 Serial Number ISO 7000 - 2498 Date of Manufacture ISO 7000 - 2497

1. 2. 3. 4. 5. 6. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 45 of 101

7. 8. 9. Table 14 Symbols on CCD Label Symbol Meaning Source The device is to be charged with power Adapter Cable PN 10115 ONLY N/A Consult the instructions for use ISO 7000 - 1641 Unique Device Identifier N/A 10. CCD Power Supply Label N/A PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 46 of 101 4.7. PSC Protective Storage Cradle Device Label The following label is applied to the Protective Storage Cradle. 4.7.1. Symbols on PSC Device Label Table 15 Symbols on PSC Device Label Symbol Meaning Source Manufacturer Information ISO 7000 - 3082 Indicating the device is to be used by qualified investigators only, in accordance with SBI-CIP-20-002 Device Model Name N/A N/A Reference Number ISO 7000 - 2493 Serial Number ISO 7000 - 2498 Date of Manufacture ISO 7000 - 2497

1. 2. 3. 4. 5. 6. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 47 of 101 Table 15 Symbols on PSC Device Label Symbol Meaning Source Consult the instructions for use ISO 7000 - 1641 Unique Device Identifier N/A

7. 8. 5. Cleaning and Disinfection Warning Failure clean, disinfect, and sterilize the Eagle V1.2 Imaging System may result in cross-contamination, and patient or user exposure to microbiological contamination. Warning Do not clean, disinfect, or sterilize the Eagle V1.2 Imaging System when energized. Power off the device before cleaning, disinfecting, or sterilizing. Cleaning, disinfecting, or sterilizing when energized may be hazardous to the operator and/or destructive to the system. Warning Use only approved cleaning and sterilization procedures Warning Do not reuse the Eagle Custom Sterilize Sleeve or Dark Imaging Sheet. They are single use only accessories. Caution Improper cleaning/sterilization may reduce image quality. Caution Prior to disinfection or sterilization, ensure surfaces are cleaned to remove organic matter as described in the sections below. Note The user should dispose of the cleaning, disinfection, and sterilization materials according to biohazard waste control processes at their Institution. Note Follow precautions established in your facility when handling any medical device that has been used intraoperatively and has been in contact with body fluids, tissues, or blood. In accordance with the Spaulding Classification scheme, the Handheld Fluorescence Camera is classified as a critical medical device that is intended to contact normally sterile tissue, thereby introducing a likelihood of microbial transmission and risk of infection if the device is not sterile. Therefore, it is essential that the Handheld Fluorescence Camera be cleaned, sterilized, and rinsed before use or reuse to prevent PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 48 of 101 cross-contamination, and patient or user exposure to microbiological contamination as described in Section 5.1. The External Communications Hub described in sections 2.2.2 and 6.3.1.2 positioned in the sterile field is cleaned and disinfected using intermediate level disinfection wipes as described in section 5.2. The Protective Storage Cradle described in sections 0 and 6.3.5 positioned in the sterile field is cleaned using intermediate level disinfection, and steam sterilized as described in section 5.5. The Contact Charging Device described in sections 2.2.1 and 6.3.5 positioned in the non-sterile field is cleaned and disinfected using intermediate level disinfection wipes as described in section 5.3. Table 16 Infrastructure, Materials, & Equipment Required for cleaning, disinfection, and sterilization Eagle V1.2

Imaging System Component Cleaning, Disinfection, and Sterilization Method 1. Handheld Fluorescence Camera Cleaning followed by Chemical Sterilization before use. Clean and Disinfect Before and After Use. Basin Item Description Dedicated workspace divided into non-sterile and sterile areas To perform cleaning and sterilization Soap and Water To clean Glutaraldehyde Chemical sterilant Latex gloves, masks, hair bonnets, gowns Personal protective equipment To hold chemical sterilant To time and monitor the sterilization process To wipe down the sterilized device To wrap the sterilized device Timer and Thermometer Lint-free cloth Sterile blue cloth PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 49 of 101 Table 16 Infrastructure, Materials, & Equipment Required for cleaning, disinfection, and sterilization Eagle V1.2

Imaging System Component 2. External Communications Hub Cleaning, Disinfection, and Sterilization Method Cleaned and disinfected using intermediate level disinfection wipes 3. Protective Storage Cradle 4. Contact Charging Device 5. Dark Imaging Box Cleaned Using Intermediate Level Disinfection, and Steam Sterilized

(Autoclave) Cleaned and disinfected using intermediate level disinfection wipes Cleaned and disinfected using intermediate level disinfection wipes Item Description Enzymatic Detergent Solution To clean and disinfect the Contact Charging Device Intermediate Level Disinfection Wipes Autoclave To clean the Protective Storage Cradle To steam sterilize the Protective Storage Cradle 4X Intermediate Level Disinfection Wipes To clean and disinfect the Contact Charging Device 4X Intermediate Level Disinfection Wipes To clean and disinfect the Contact Charging Device 6. Custom Sterile Sleeve N/A This component is Single Use N/A 7. Dark Imaging Sheet N/A This component is Single Use N/A N/A N/A PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 50 of 101 5.1. HFC Handheld Fluorescence Camera Cleaning and Sterilization Before use, the Handheld Fluorescence Camera must be sterilized. SBI ALApharma Canada Inc. has validated and therefore recommends the use of mild soap and water as an effective cleaning agent before sterilizing the Handheld Fluorescence Camera with glutaraldehyde

(2.5% solution). Following immediate use and before re-sterilization, SBI ALApharma Canada Inc. recommends to clean and disinfect the Handheld Fluorescence Camera with Intermediate Level Disinfection wipes. 5.1.1. Cleaning the HFC Table 17Handheld Fluorescence Camera Cleaning Instructions 1. Prior to sterilization, the HFC must be thoroughly cleaned with mild soap and water to remove organic matter. 2. Wear appropriate PPE (e.g. impervious gloves such as latex gloves, masks, hair bonnets, gowns). 3. Before cleaning, ensure that the hatch covering the USB-c port is closed and secured in place. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 51 of 101 Table 17Handheld Fluorescence Camera Cleaning Instructions 4. Thoroughly clean the HFC using mild soap and water. 5. With the naked eye, visually inspect the device in a well-lit area at a distance of approximately 12 inches to ensure all surfaces are clean. If necessary, repeat the cleaning steps above until the HFC is clean. 5.2.1. Sterilizing the HFC Table 18 Handheld Fluorescence Camera Sterilization Instructions The glutaraldehyde (2.5% solution) liquid chemical sterilant should be used according the manufacturers instructions, including requirements for appropriate ventilation, use of PPE, training and quality control. 1. 2. Liquid chemical sterilization should be performed in a dedicated workspace divided into a non-sterile and sterile area. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 52 of 101 Table 18 Handheld Fluorescence Camera Sterilization Instructions 3. Before sterilizing, ensure the device has been properly cleaned according and that the USB-c hatch is closed and secured in place. 4. In the non-sterile area of the dedicated workspace, prepare a basin containing liquid chemical sterilant according the manufacturers instructions to achieve the appropriate dilution 5. Ensure the HFC is cleaned and completely dry prior to immersing in the sterilant. 6. Fully immerse the HFC in the liquid chemical bath ensuring all surfaces of the device are fully immersed. 7. Soak the device for 10 hours, monitoring (e.g. temperature) as per the sterilant manufacturers recommendations 8. Remove the HFC using sterile technique and rinse according to the sterilant manufacturers instructions. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 53 of 101 Table 18 Handheld Fluorescence Camera Sterilization Instructions 9. Completely dry the HFC by wiping with a sterile lint-free cloth. 10. Visually inspect the device to verify there are no signs of corrosion, discoloration, pitting, or cracked of seals. Visually inspect the HFC to ensure the optical glass (Item X in Figure X) is free of any visible material (e.g. fibers) or smudges (e.g. water stains). Use sterile lint-free cloth to wipe the optical glass if required. 11. In the sterile area of the dedicated workspace, wrap the HFC in a sterile blue cloth. 12. The HFC is now sterile and ready for use. 5.2. ECH External Communications Hub Cleaning and Disinfection Warning Do not clean or disinfect the ECH or any of its components when energized. Unplug all cable connections before cleaning or disinfecting. Cleaning or disinfecting when energized may be hazardous to the operator and/or destructive to the device(s). Caution Prior to disinfection, ensure surfaces are cleaned to remove organic matter as described in the sections below. Thoroughly clean and disinfect all External Communications Hub component surfaces including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables using Intermediate Level Disinfection Wipes. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 54 of 101 5.2.1. Cleaning ECH Table 19 External Communication Hub Cleaning Instructions 1. Wear impervious gloves such as latex gloves when handling Intermediate Level Disinfection Wipes. 2. Before cleaning, ensure the ECH and all components are UNPLUGGED from their power supplies, and ensure the all power supplies are UNPLUGGED from electrical outlets. 3. Use at least two new Intermediate Level Disinfection Wipes to clean and remove all visible soil and debris from all ECH component surfaces including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables. 4. Thoroughly clean crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. 5. As necessary, use additional Intermediate Level Disinfection Wipes if they become soiled during the cleaning process. 6. In a well-lit area, visually inspect (at a distance of approximately 12 inches) the ECH including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables to ensure all surfaces are clean. 7. If necessary, repeat the cleaning steps above until the ECH and its components are clean 5.2.2. Disinfecting ECH Do not continue with disinfecting the ECH including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables unless the cleaning process described in Section 5.2.1 is completed. Effective disinfection can only be achieved after completing the cleaning process. Table 20 External Communication Hub Disinfection Instructions 1. After cleaning, use at least two new Intermediate Level Disinfection Wipes to thoroughly wet ALL SIDES and surfaces of the ECH including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables. 2. Thoroughly wipe crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. 3. Use additional Intermediate Level Disinfection Wipes as necessary to ensure ALL SIDES and surfaces of the ECH including the ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables have been wet. 4. Once wet, allow ECH Display, ECH PC, ECH Pad, ECH Stand, ECH Power Supplies, and cables to dry. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 55 of 101 Table 20 External Communication Hub Disinfection Instructions 5. The ECH and its components are now disinfected and ready for use. Observe sterile technique when transporting equipment from re-processing locations to points of use. 5.3. Dark Imaging Box Cleaning and Disinfection Caution Prior to disinfection, ensure surfaces are cleaned to remove organic matter as described in the sections below. Before and after use, thoroughly clean and disinfect all surfaces of the Dark Imaging Box using Intermediate Level Disinfection Wipes. 5.3.1. Cleaning Dark Imaging Box Table 21 Dark Imaging Box Cleaning Instructions 1. Wear impervious gloves such as latex gloves when handling Intermediate Level Disinfection Wipes. 2. Before cleaning, ensure the Dark Imaging Sheet (Section 2.2.2 and Section 6.3.3), the DIB Front Cover, and DIB Back Cover (Section 6.3.4) are removed and detached from the DIB, and discarded. The Dark Imaging Sheet, DIB Front Cover, and DIB Back Cover are to be discarded after single use. 3. Use at least two (2) new Intermediate Level Disinfection Wipes to clean and remove all visible soil and debris from the DIB including its Base, Cradle, Adjustment Wheel, Ruler, and Imaging Platform. 4. Thoroughly clean crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. 5. As necessary, use additional Intermediate Level Disinfection Wipes if they become soiled during the cleaning process. 6. In a well-lit area, visually inspect (at a distance of approximately 12 inches) the DIB including its Base, Cradle, Adjustment Wheel, Ruler, and Imaging Platform to ensure all surfaces are clean. If necessary, repeat the cleaning steps above until the DIB is clean. 5.3.2. Disinfecting Dark Imaging Box Do not continue with disinfecting the DIB unless the cleaning process described in Section 5.3.1 is completed. Effective disinfection can only be achieved after completing the cleaning process. Table 22 Dark Imaging Box Disinfection Instructions 1. After cleaning, use at least two new Intermediate Level Disinfection Wipes to thoroughly wet ALL SIDES and surfaces of the DIB including its Base, Cradle, Adjustment Wheel, Ruler, and Imaging Platform. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 56 of 101 Table 22 Dark Imaging Box Disinfection Instructions Thoroughly wipe crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. Use additional Intermediate Level Disinfection Wipes as necessary to ensure ALL SIDES and surfaces of the DIB including its Base, Cradle, Adjustment Wheel, Ruler, and Imaging Platform have been wet. 2. 3. 4. Once wet, allow the DIB to dry. 5. The DIB is now disinfected and ready for use. Observe sterile technique when transporting equipment from re-processing locations to points of use. 5.4. CCD Contact Charging Device Cleaning and Disinfection Warning Do not clean or disinfect the Contact Charging Device, its power supply, or its cables when energized. Unplug all cable connections before cleaning or disinfecting. Cleaning or disinfecting when energized may be hazardous to the operator and/or destructive to the device(s). Caution Prior to disinfection, ensure surfaces are cleaned to remove organic matter as described in the sections below. Thoroughly clean and disinfect all surfaces of the Contact Charging Device, the CCD Power Supply, and the cables using Intermediate Level Disinfection Wipes. 5.4.1. Cleaning CCD Table 23 Contact Charging Device Cleaning Instructions 1. Wear impervious gloves such as latex gloves when handling Intermediate Level Disinfection Wipes. 2. Before cleaning, ensure the CCD is UNPLUGGED from the CCD Power Supply, and ensure the CCD Power Supply is UNPLUGGED from the electrical outlet. 3. Use at least two new Intermediate Level Disinfection Wipes to clean and remove all visible soil and debris from the CCD, the CCD Power Supply, and all cables. 4. Thoroughly clean crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. 5. As necessary, use additional Intermediate Level Disinfection Wipes if they become soiled during the cleaning process. 6. In a well-lit area, visually inspect (at a distance of approximately 12 inches) the CCD, the CCD Power Supply, and all cables to ensure all surfaces are clean. If necessary, repeat the cleaning steps above until the CCD, the CCD Power Supply, and all cables are clean. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 57 of 101 5.4.2. Disinfecting CCD Do not continue with disinfecting the CCD, the CCD Power Supply, or cables unless the cleaning process described in Section 5.4.1 is completed. Effective disinfection can only be achieved after completing the cleaning process. Table 24 Contact Charging Device Disinfection Instructions 1. After cleaning, use at least two new Intermediate Level Disinfection Wipes to thoroughly wet ALL SIDES and surfaces of the CCD, the CCD Power Supply, and Cables. 2. Thoroughly wipe crevices and areas that are difficult to reach. Where required, fold or bunch Intermediate Level Disinfection Wipes to push into crevices, corners, and areas that are difficult to reach. 3. Use additional Intermediate Level Disinfection Wipes as necessary to ensure ALL SIDES and surfaces of the CCD, the CCD Power Supply, and Cables have been wet. 4. Once wet, allow the CCD, the CCD Power Supply, and Cables to dry. 5. The CCD, the CCD Power Supply, and Cables are now disinfected and ready for use. Observe sterile technique when transporting equipment from re-processing locations to points of use. 5.5. PSC Protective Storage Cradle Cleaning and Sterilization Before use, clean and sterilize the Protective Storage Cradle. 5.5.1. Cleaning Protective Storage Cradle Table 25 Protective Storage Cradle Manual Cleaning Instructions 1. Prepare Prolystica 2x Concentrate Presoak and Cleaner enzymatic detergent solution per manufacturers instructions (1/8 fl. oz./gal to 1/2 fl. oz./gal) with lukewarm tap water (22C to 30C temperature range). 2. Immerse the device(s) in the prepared solution and soak for one (1) to five (5) minutes. 3. Use a non-linting wipe or cloth saturated with the detergent solution to wipe all device surfaces until visibly clean. 4. Rinse the device(s) in a tap water (or better) bath for at least 30 seconds. 5. Thoroughly dry all surfaces of the device(s) using non-linting wipes or cloths, changing wipes/ cloths when necessary to ensure the devices are completely dry. 6. Visually inspect each device for the absence or presence of remaining soil in a well-lit area. If soil is present, repeat the manual cleaning steps until all visible soil is removed. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 58 of 101 5.5.2. Sterilizing Protective Storage Cradle Do not continue with sterilizing the Protective Storage Cradle unless the cleaning process described in section 5.5.1 is completed. Effective sterilization can only be achieved after completing the cleaning process. Steam sterilize the Protective Storage Cradle according to the following instructions. 2. 3. Table 26 Protective Storage Cradle Sterilization Instructions 1. Place Protective Storage Cradle in a double-wrapped sterilization configuration Subject PSC to full cycles of either 1) Four (4) minutes of exposure time at 132C using prevacuum air removal 2) Three (3) minutes of exposure time at 134C using prevacuum air removal Subject PSC to dry times of either 1) 20 to 30 minutes of dry time after 132C with four (4) minutes exposure using prevacuum air removal following Four (4) minutes of exposure time at 132C using prevacuum air removal 2) 20 minutes of dry time after 134C with three (3) minutes exposure using prevacuum air removal following three (3) minutes of exposure time at 134C using prevacuum air removal 4. The PSC is now disinfected and ready for use. Observe sterile technique when transporting equipment from re-processing locations to points of use. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 59 of 101 6. Operating the Handheld Fluorescence Camera, and Eagle V1.2 Imaging System Accessories 6.2. HFC Handheld Fluorescence Imaging Device Overview and Operation 6.2.1. Tactile Interface Table 27 Tactile Interface Buttons

Icon Name Description 1. 2. Video Button during White Light or Pressing the video button Fluorescence Imaging begins video recording. Pressing the Video Button again stops and saves the video recording. Camera Button Pressing the camera button captures an image during White Light Imaging or Fluorescence Imaging. Pressing the camera button during a White Light or Fluorescence Imaging video recording captures an image. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 60 of 101 3. 4. 5. 6. 8. 9. Table 27 Tactile Interface Buttons

Icon Name Description White Light Imaging button Pressing this button initiates White Light Imaging Mode (section 6.2.2.2.4) from Imaging Mode (Section Fluorescence Imaging button Pressing this button initiates Fluorescence Imaging

(Section 6.2.2.2.5) from Imaging Mode (Section 6.2.2.2) 6.2.2.2) Battery Status LED Communicates battery charging status and battery level (Section 6.2.1.3) Power Button Used to power on, power off, and sleep the HFC Display Screen (Section 6.2.1.2) 7. N/A Touch Display Touch Display Screen to control the Software User Screen Interface described in Section 6.2.1.2 Future Functionality Non functioning button for future functionality System Status LED Communicates the power status (Section 6.2.1.4) 6.2.1.1. Power On Table 28 Power On Instruction

(located Hold the Power Button in the center top right of the Tactile Interface 6.2.1) for 3 seconds to 1. power on the Handheld Fluorescence Camera. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 61 of 101 Table 28 Power On Instruction 2. During device start-up the SBI ALApharma Canada Inc. splash screen will be displayed. 3. Soon after, the Session Menu

(section 6.2.2.1) is displayed. 4. Refer to Sections 6.3.2.2 and 6.3.2.3 for information on using the Enable Casting button and ECH connection status. 6.2.1.2. Shutdown / Power Off Table 29 Power Off Instruction 1. Access the Session Menu (section 6.2.2.1) to power off the device. 2. From the Session menu to power off the device, press Shutdown device PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 62 of 101 Table 29 Power Off Instruction When prompted, press to return to the Session Menu, or press 3. to shutdown the device. 6.2.1.3. Battery Status LED The Battery Status LED (Table 27 item 61) blinks Amber in color if the device is charging and the battery level is greater than 20% and less than 80%. blinks Green in color if the device is charging and the battery level is greater than 80% less than 100%. is solid Green color if the HFC is charging and the battery level reaches 100%

The blink rate of the Battery Status LED is one (1) blink per two (2) seconds if the battery is being charged from a PC. is two (2) blinks per second if the battery is being charged directly from the CCD Power Supply is four (4) blinks per second if the battery is being charged from the CCD per Section 6.3.5 is Red in color once every 5 (five) seconds if the battery is less than or equal to 5% when HFC is powered off and when the battery is not charging is OFF when the HFC is powered off and the battery is greater than 5%

6.2.1.4. System Status LED The System Status LED (Table 27 item 9) is Green in color while in the power on or standby state if the device is functioning normally is Amber in color while in the power on or standby state if the device detects a hardware warning that requires attention o this typically occurs when the temperature sensor in the HFC Optical Head is approaching thermal operating limits is Red in color a critical hardware error is detected o o in case of a critical hardware failure, the firmware power offs the device and may prevent the device from powering on this typically occurs when temperature sensors in the HFC Optical Head have reached thermal operating limits. When this occurs, white light and blue-violet LED are shut down and the System Status LED is Red in color blinks Red if there is a diagnostics failure during Power on Is OFF when the HFC is powered off PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 63 of 101 6.2.2. Software User Interface 6.2.2.1. Session Menu Begin imaging or review captured images and videos from the Session Menu. Table 30 Session Menu Instruction After powering on, the Session Menu is displayed. To begin imaging, press Or Press New patient session to begin a new imaging session. Press Continue previous session to continue the last imaging session. Press Demo session to begin a demo imaging Press Review sessions to review saved images session. and videos. 6.2.2.1.1. New Patient Session 1. 2. 3. 4. 5. To review saved images and videos, press Images and videos saved in a new patient session are saved into a session, accessed through Review Session menu Table 31 New Patient Session Instruction Press New patient session to begin a new imaging 1. session. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 64 of 101 Table 31 New Patient Session Instruction Before imaging, enter the Session ID or Patient ID using the onscreen keypad. 2. Press to return to the Session Menu. Press to begin imaging. Imaging Mode is initiated after pressing

. 3. White Light (Section 6.2.2.2.4) or Fluorescence Imaging (Section 6.2.2.2.5) can now be performed. 6.2.2.1.2. Continue Previous Session Continue a previous session to continue saving images and videos to the session. Images and videos saved from a continued session are organized into a sub-session. All sessions and captured images and videos are accessed through the Review Session menu. Table 32 Previous Session Instruction Press Continue previous session to continue the last 1. imaging session. Press to return to the Session Menu. 2. Press to continue the last session, and begin imaging. Imaging Mode is initiated after pressing

. 3. White Light (Section 6.2.2.2.4) or Fluorescence Imaging

(Section 6.2.2.2.5) can now be performed. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 65 of 101 6.2.2.1.3. Demo Session A Demo Session doesnt require entry of a Session ID or patient ID and images are saved to Sessions named with prefix 000. Table 33 Demo Session Instruction 6.2.2.1.4. Review Session and Review Images/Videos Images and videos captured under White Light Imaging or Fluorescence Imaging are automatically saved. From the Sessions Menu, press to review saved data. Table 34 Review Images and Videos Instruction 1. 2. 1. 2. 3. 4. Press Demo session to begin a demo session. Imaging Mode is initiated after pressing

. White Light (Section 6.2.2.2.4) or Fluorescence Imaging (Section 6.2.2.2.5) can now be performed. Press Review sessions to review saved images and All sessions are shown. Press a session to explore it. Press the Back button to return to the Session Sessions may be comprised of sub-sessions. Press the Back button to return to the previous Saved images and videos are found within a session or sub-session Press the Back button to return to the previous videos. Menu. screen. screen. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 66 of 101 Table 34 Review Images and Videos Instruction 5. 6. 7. Pressing on a saved image will open the image. Press the Back button to return to the session. Pressing on a saved video will open the video. Pressing the Play button will play the video. Pressing the Pause button will pause video playback. Press and drag the playback slider to the desired position to select video playback start point. Press the Back button to return to the session. Pressing on the Information button on an opened image or video will display the Media information. Pressing on the Device Info tab from the Information window will display the Device Information. Press to close the Information tab. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 67 of 101 6.2.2.2. Imaging Mode Imaging Mode is enabled once a new patient session has been created (Section 6.2.2.1.1), a previous session is continued (Section 6.2.2.1.2), or a Demo Session has been started (Section 6.2.2.1.3). Figure 8 shows the Imaging Mode user interface. Handheld Fluorescence Cameras User Interface under Imaging Mode Figure 8:

PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 68 of 101 Table 35 Imaging Mode User Interface Icons

Icon Name Description 1. Imaging Field of View 2. Circle of Interest N/A N/A Indicates the borders of the imaging field of view Recommended imaging region for Fluorescence Imaging. Imaging in this region ensures optimal Fluorescence Imaging. 3. 4. 5. 7. 8. 9. 6. Capture Video Icon Pressing the active video icon begins video End Session Icon Pressing this button will end the current imaging session after prompting. Device Information Pressing this button will display device Icon information. This icon turns grey during Fluorescence Imaging or White Light Imaging to white Capture Image Icon indicating the camera icon is active. Pressing the active camera icon captures an image. This icon turns grey during Fluorescence Imaging or White Light Imaging to white indicating the icon is active. recording. During video recording, the video icon is highlighted red

. Pressing the active video icon again stops and saves the video recording. Review Session Icon Pressing this button will display the Review Session screen (section 6.2.2.1.4) Fluorescence Imaging Icon Pressing this button initiates Fluorescence Imaging from Imaging Mode. This icon turns during Fluorescence to blue white Imaging (section 6.2.2.2.5). Pressing this button initiates White Light White Light Imaging Imaging Mode. This icon turns from white Icon to blue during White Light Imaging

(section 6.2.2.2.4). PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 69 of 101 Table 35 Imaging Mode User Interface Icons

Icon Name Description 10. 11. 12. Ambient Light Sensor Warning Icon This icon appears overlaid in the top right corner of the Imaging Field of View when the Ambient Lighter Warning has been accepted Range Finder (RF) These range icons appear in the bottom center of the Imaging Field of View when the camera sensor is too close or too far from the imaging target. Temperature Gauge The temperature gauge communicates relative temperature to the operator. 6.2.2.2.1. Temperature Gauge The temperature gauge communicates relative temperature to the operator. When the gauge approaches full, the HFC is approaching a maximum operating temperature of 41C. When operating temperature of 41C is reached, the HFC automatically disables white light or blue-violet LEDs. 6.2.2.2.2. Range Finder (RF) During White Light Imaging or Fluorescence Imaging, the Range Finder will provide real time instruction to Move back from or Move closer to the imaging target. When the optimal imaging range has been met, the Range Finder is not present on the display screen. Capturing images or videos when the Range Finder is present may result in reduced image quality. 6.2.2.2.3. Circle of Interest Align imaging targets during White Light Imaging and Fluorescence Imaging within the Circle of Interest. Imaging within the Circle of Interest ensures the imaging target is uniformly illuminated during White Light Imaging and Fluorescence Imaging. Do not use fluorescence information observed outside the Circle of Interest when interpreting fluorescence images per Section 6.2.2.2.5.2. 6.2.2.2.4. White Light Imaging Accessed through Imaging Mode, White Light Imaging can only be performed after creating a new patient session (Section 6.2.2.1.1), continuing a previous session (Section 6.2.2.1.2), or beginning a Demo Session (Section 6.2.2.1.3). PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 70 of 101 Table 36 White Light Imaging Instruction 1. Enter Imaging Mode per Section 6.2.2.2. 2. While in Imaging Mode, press the WL button on the right side of the HFC tactile interface (Section 6.2.1) or the White Light Imaging Icon on the right side of the Software User Interface (Section 6.2.2) to initiate White Light Imaging. 3. The white WL icon pressed to begin White Light Imaging turns blue when the WL button on the tactile interface is 4. Move back, or move closer to the imaging target as directed by the Range Finder icons. Before capturing an image or video, verify correct imaging range by monitoring the onscreen Range Finder icons. 5. Press the Camera button on the left side of the HFC Tactile Interface (Section 6.2.1) or the Capture Image Icon on the left side of the Software User Interface (Section 6.2.2) to capture an image. After an image is captured, annotate the image with one

(1) of eight (8) annotations:

6. P, A S, I, M, L, 01, or 02 7. Press the Video button on the left side of the HFC tactile interface (Section 6.2.1) or the Video Capture Icon on the left side of the Software User Interface (Section 6.2.2) to start video recording. Press the Video button again to stop video recording. During video recording, pressing the Camera button will capture an image. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 71 of 101 6.2.2.2.5. Fluorescence Imaging Accessed through Imaging Mode, White Light Imaging can only be performed after creating a new patient session (Section 6.2.2.1.1), continuing a previous session (Section 6.2.2.1.2), or beginning a Demo Session (Section 6.2.2.1.3). Table 37 Table XX Fluorescence Imaging Instruction 1. Enter Imaging Mode per Section 6.2.2.2. Fluorescence Imaging must be performed in the darkness. When correct ambient lighting conditions are met, the FL icon located in the top right corner of the Imaging Modes user interface is circled in blue. 2. Refer to Section 6.2.2.2.5.1 if prompted with Warning: ambient light is too bright for Fluorescence Imaging. 3. While in Imaging Mode with the FL icon circled in blue, press the FL button on the right side of the HFC tactile interface (Section 6.2.1) or the Fluorescence Light Imaging Icon on the right side of the Software User Interface (Section 6.2.2) to initiate Fluorescence Imaging. 4. The white FL icon pressed to begin Fluorescence Imaging. turns blue when the FL button on the tactile interface is Move back, or move closer to the imaging target as directed by the Range Finder icons 5. Before capturing an image or video, verify correct imaging range by monitoring the onscreen Range Finder icons. 6. Press the Camera button on the left side of the HFC Tactile Interface (Section 6.2.1) or the Capture Image Icon on the left side of the Software User Interface

(Section 6.2.2) to capture an image. 7. Press the Video button on the left side of the HFC tactile interface (Section 6.2.1) or the Video Capture Icon on the left side of the User Interface (Section 6.2.2) to start video recording. Press the Video button again to stop video recording. During video recording, pressing the Camera button will capture an image. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 72 of 101 6.2.2.2.5.1. Ambient Light Warning When attempting to initiate Fluorescence Imaging when incorrect ambient lighting conditions are detected, the following warning appears indicating that ambient light is too bright for Fluorescence Imaging to return to Imaging Mode. Take action to correct ambient light Press conditions by diminishing sources of light in the imaging environment until the FL icon located in the top right corner of the Imaging Modes user interface is circled in blue. on the warning will initiate Fluorescence Imaging with the Ambient Pressing Light Warning icon overlaid in the top right corner of the Imaging Field of View. Any image or video captured in this condition includes the Ambient Light Warning icon to indicate that incorrect ambient lighting conditions were used to capture the image or video. Proceeding with Fluorescence Imaging using incorrect ambient lighting conditions is not recommended and may result in reduced image quality. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 73 of 101 6.2.2.2.5.2. Interpretation of Fluorescence Images Table 38 provides exemplary white light and fluorescence images of grossly sectioned breast tissue specimens. Areas of red PpIX fluorescence are contrasted with areas of healthy tissue autofluorescence which typically appear predominately green and brown. Areas containing connective tissue typically appear green fluorescent. Areas composed predominately of adipose tissue typically appear dull pink or brown. Tissue specimen ink applied to tissue margins typically appears black. Blood vessels and blood also typically appear black; however, they may also have a dark red hue. Areas of white indicate pixel saturation and should not be considered when interpreting the images for PpIX fluorescence. The Handheld Fluorescence Camera utilizes auto-exposure to optimize the exposure settings based on lighting conditions. Images captured on the HFC are relative, not quantitative, and may not represent absolute fluorescence levels. Table 38 Interpretation of Fluorescence Images White Light Images Fluorescence Images 1. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 74 of 101 Table 38 Interpretation of Fluorescence Images White Light Images Fluorescence Images 2. 3. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 75 of 101 Table 38 Interpretation of Fluorescence Images White Light Images Fluorescence Images 4. 5. 6.2.2.3. Saving Data Whenever an image or video is captured under White Light Imaging (Section 6.2.2.2.4) or Fluorescence Imaging (Section 6.2.2.2.5), it is automatically saved to the ECH Flash Drive. Saved data can be reviewed from the Sessions Menu described in section 6.2.2.1. 6.2.2.4. Exporting Data All data is saved to the ECH Flash Drive. Install and unlock the ECH Flash Drive on a separate PC to access saved data. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 76 of 101 6.3. Accessories Overview and Operation 6.3.1. Custom Sterile Sleeve (CSS) Instructions for Use The Custom Sterile Sleeve can be sheathed around the Handheld Fluorescence Camera in two (2) ways to accommodate both ECH Wireless (Section 6.3.2.2) and ECH Wired (Section 6.3.2.3) Configurations. Observe sterile technique when mounting the CSS as described in the next Sections 6.3.1.1 and 6.3.1.2. 6.3.1.1. Custom Sterile Sleeve Wireless Configuration Table 39 Custom Sterile Sleeve Wireless Configuration Instructions 1. Ensure the External Communications Hub (ECH) is set up for ECH Wireless Configurations per Section 6.3.2.1. Pull the CSS out of its packaging. Unfold the CSS. 2. Prepare the CSS, two (2) small sterile bags, and three (3) pieces of tape on a flat surface in the sterile field. 3. Position the HFC on flat work surface in the sterile field. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 77 of 101 Table 39 Custom Sterile Sleeve Wireless Configuration Instructions Prepare to remove the HFC USB Hatch with sterile technique by placing thumb and index finger inside one

(1) small sterile bag provided with the CSS. 4. Pinch-grip, twist, and pull the HFC USB Hatch to remove it. 5. Use the small sterile bag to hold the HFC USB Hatch with sterile technique. Connect the HFC USB Cable to the HFC. 6. Position the HFC USB Cable 90 Type-C connector such that it points towards the inside of the HFC. 7. Using provided tape, secure the opposite end of the HFC USB Cable to the work bench. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 78 of 101 Table 39 Custom Sterile Sleeve Wireless Configuration Instructions Link the HFC USB Cable to the ECH Link Cable while observing sterile technique. Connect ECH Link Cable to ECH PC USB Port per Section 6.3.2.2 Step 8. 8. Before proceeding to the next step in this instruction, verify successful connection between the HFC and ECH per Section 6.3.2.2 Steps 8 through 14. 9. After verifying successful connection between the HFC and ECH per Section 6.3.2.2, unplug the HFC USB Cable 90 Type-C connector from the HFC. 10. Prepare to cover the HFC USB Cable 90 Type-C connector by collecting one

(1) small sterile bag and one

(1) piece of tape. Cover the HFC USB Cable 90 Type-C connector with small sterile bag and seal bottom opening with tape. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 79 of 101 Table 39 Custom Sterile Sleeve Wireless Configuration Instructions Prepare to re-attach the HFC USB Hatch with sterile technique. 11. While pinch-gripping the HFC USB Hatch with the small sterile bag, push and twist the HFC USB Hatch to re-attach it. The HFC is now ready to be sheathed with the CSS. Slide the HFC into the CSS. Fit the CSS over the HFC optical head. 12. Ensure the CSS optical window snaps onto the optical head. Position the HFC in the top right of the CSS such that any CSS slack material hangs off the left side of the HFC, while the CSS Tape is flush with the right side of the HFC. Pull the CSS taut over the body of the HFC. Pull CSS slack material taut from the bottom and left, and wrap the HFC in a gift-wrap style. 13. Lay the unused telescopic HFC USB Cable Cover across the body of HFC. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 80 of 101 Table 39 Custom Sterile Sleeve Wireless Configuration Instructions 14. Pull CSS slack material taut from the bottom and left, and wrap the HFC in a gift-wrap style. Pull off the adhesive backing from the CSS Tape while keeping the gift-wrapped CSS material in position. 15. Lay the CSS Tape over the gift-

wrapped CSS material. 16. Lay and push the CSS Tape firmly across the backside of the HFC body. Flip the HFC around and finish adhering the CSS Tape around the right front side of the HFC. 17. The Handheld Fluorescence Camera is now sheathed in the Custom Sterile Sleeve using the ECH Wireless Configuration (Section 6.3.2.1), and ready for Imaging per Section 6.2.2.2. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 81 of 101 6.3.1.2. Custom Sterile Sleeve Wired Configuration Table 40 Custom Sterile Sleeve Wired Configuration Instructions 1. Ensure the External Communications Hub (ECH) is set up for ECH Wired Configurations per Section 6.3.2.3. Pull the CSS out of its packaging. Unfold the CSS. 2. Prepare the CSS, two (2) small sterile bags, and three (3) pieces of tape on a flat surface in the sterile field. 3. Slide the HFC into the CSS. Fit the CSS over the HFC optical head. Ensure the CSS optical window snaps onto the optical head. Position the HFC in the top right of the CSS such that any CSS slack material hangs off the left side of the HFC, while the CSS Tape is flush with the right side of the HFC. 4. Run the HFC USB Cable through the CSS 6-foot-long telescopic HFC USB Cable Cover. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 82 of 101 Table 40 Custom Sterile Sleeve Wired Configuration Instructions 5. Pull to fully extend the telescopic HFC USB Cable Cover. Run the HFC USB Cable through the telescopic HFC USB Cable Cover 6. Pull to align the HFC USB Cable 90 Type-C connector with the HFC USB Hatch, leaving enough slack to orient and manoeuvre the cable easily. Using provided tape, secure the opposite end of the HFC USB cable to the work bench, allowing sufficient slack to orient and manoeuvre the HFC during imaging. Prepare to remove the HFC USB Hatch with sterile technique by placing thumb and index finger inside one small sterile bag provided with the CSS. 7. Pinch-grip, twist, and pull the HFC USB Hatch to remove it. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 83 of 101 Table 40 Custom Sterile Sleeve Wired Configuration Instructions 8. While holding the HFC USB Hatch, turn the small sterile bag inside-out to safeguard the HFC USB Hatch while not in use. 9. Connect the HFC USB Cable to the HFC. Position the HFC USB Cable 90 Type-C connector such that it points towards the inside of the HFC. Link the HFC USB Cable to the ECH Link Cable, while observing sterile technique. Connect ECH Link Cable to ECH PC USB Port per Section 6.3.2.3 Step 8. 10. Before proceeding to the next step in this instruction, verify successful connection between the HFC and ECH per Section 6.3.2.3 Steps 8 through 14. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 84 of 101 Table 40 Custom Sterile Sleeve Wired Configuration Instructions 11. 12. Pull the CSS taut over the body of the HFC. Position the sheathed HFC USB Cable along the bottom and left side of the HFC body. Ensure the HFC remains positioned in the top right of the CSS such that any CSS slack material hangs off the left side of the HFC, while the CSS Tape is flush with the right side of the HFC. Pull CSS slack material taut from the bottom and left, and wrap the HFC in a gift-

wrap style. Pull off the adhesive backing from the CSS Tape while keeping the gift-wrapped CSS material in position. 13. Lay the CSS Tape over the gift-

wrapped CSS material. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 85 of 101 Table 40 Custom Sterile Sleeve Wired Configuration Instructions Lay and push the CSS Tape firmly across the backside of the HFC body, ensuring the CSS Tape contours along the sheathed HFC USB Cable positioned in Step 11. Flip the HFC around and finish adhering the CSS Tape around the right front side of the HFC. 14. 15. The Handheld Fluorescence Camera is now sheathed in the Custom Sterile Sleeve using the ECH Wired Configuration (Section 6.3.2.3), and ready for Imaging per Section 6.2.2.2. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 86 of 101 6.3.2. External Communications Hub (ECH) Instructions for Use Once assembled according to Section 6.3.2.1 The External Communications Hub can be configured in a wireless or wired fashion to cast the Handheld Fluorescence Cameras display on to the ECH Display. The HFC display is cast wirelessly to ECH Display Monitor when the HFC is connected to the ECH PC, using ECH Router. Follow instructions in Section 6.3.2.2 to set up the ECH Wireless Configuration. The HFC display is cast directly to ECH Display Monitor when the HFC is connected to the ECH PC, using HFC USB Cable with ECH Link Cable. Follow instructions in Section 6.3.2.3 to set up the ECH Wired Configuration. The ECH support connecting up to two (2) Handheld Fluorescence Cameras at once. When two (2) Handheld Fluorescence Cameras are connected to ECH:

the ECH automatically saves data captured on either device, to the other data from one HFC can be reviewed on the HFC, and vice versa until the HFC is shutdown only 1 HFC can be casted to the ECH Follow instruction in Step 9 of Section 6.3.2.2 and Step 9 of 6.3.2.3 to connect two (2) Handheld Fluorescence Cameras to the ECH. 6.3.2.1. ECH Assembly Instructions Table 41 External Communications Hub Assembly Instructions 1. Mount ECH Desk onto ECH Cart. 2. Mount ECH Shelf onto ECH Cart. 3. Mount ECH Basket onto ECH Cart PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 87 of 101 Table 41 External Communications Hub Assembly Instructions 4. Mount ECH Power Bar onto ECH Cart. 5. Plug ECH Extension Cord into ECH Power Bar. 6. Mount ECH Display Monitor onto ECH Cart. Plug ECH Display Monitor into ECH Power Bar. Place ECH PC onto the ECH Desk. Connect the ECH Numeric Pad. 7. Install ECH Flash Drive into ECH PC. Plug ECH PC into ECH Power Bar. 8. Plug ECH PC Power supply into ECH Power Bar. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 88 of 101 Table 41 External Communications Hub Assembly Instructions Link the HFC USB Cable to the ECH Link Cable. 9. Connect the ECH Link Cable to ECH PC. Coil linked HFC USB Cable and ECH Link Cable and place on ECH Desk. 10. Slide the adjustable ECH Shelf to maximum height. 11. Place ECH Router with power supply and ethernet cable assembly onto ECH Shelf. Plug ECH Router power supply into ECH Power Bar. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 89 of 101 Table 41 External Communications Hub Assembly Instructions 12. Plug ethernet cable into ECH PC. Assemble ECH DVI Link Assembly comprised of:

DVI Link Transmitter (Tx) DVI Link Receiver (Rx) Tx Power Supply Rx Power Supply Optical Cable DVI to HDMI Cable 13. Plug Tx Power Supply into ECH Power Par. Plug Rx Power Supply into ECH Power Bar. 14. Plug HDMI connector into ECH PC. Plug DVI Link Receiver (Rx) into ECH Display Monitor DVI Port. Verify 5 power supplies are connected to the ECH Power Bar:

15. ECH Display Monitor ECH PC ECH DVI Link Rx ECH DVI Link Tx PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 90 of 101 Table 41 External Communications Hub Assembly Instructions ECH Router Coil cables, and use provided ECH assembly hardware for cable management. 16. Place power supplies and excess cabling into the ECH Basket. 17. Plug ECH Extension Cord into electrical outlet. 18. Power on the ECH Display Monitor, ECH PC, and ECH Router. 19. The ECH is assembled, powered on and ready for casting the Handheld Fluorescence Cameras display. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 91 of 101 Table 41 External Communications Hub Assembly Instructions 20. Setup ECH Wireless Connection following Section 6.3.2.2 or ECH Wired configuration following Section 6.3.2.3. 6.3.2.2. ECH Wireless Configuration Table 42 External Communications Hub Wireless Instructions 1. Ensure the ECH has been assembled and is powered on according to section 6.3.2.1. 2. After ECH PC power on, enter authorization PIN on ECH Numeric Pad to login. 3. After successful login, the ECH Display Monitor shows the ECH Start Up screen. Shortly after, ECH prompts to Insert & Unlock USB Memory Stick. 4. Insert ECH Flash Drive into the ECH PC USB port and/or unlock encrypted ECH Flash Drive. 5. When the encrypted USB flash drive is unlocked and plugged into the ECH PC USB port, ECH notifies USB memory stick setup complete. 6. After successful login, ECH notifies Hub is ready for Wireless setup Connect First Device. Connect ECH Link Cable to the ECH PC USB Port. 8. When a successful connection is made, ECH notifies Device 1 is ready for wireless, unplug Device USB cable. Unplug HFC USB Cable 90 Type-C connector from the HFC. ECH notifies Hub is ready for Wireless setup Connect Second Device. 9. If not connecting two (2) HFCs, press Enter to move to the next step. If connecting two (2) HFCs, connect second ECH Link Cable into the ECH PC USB Port. 7. Before proceeding, ensure the Custom Sterile Sleeve (CSS) has been configured for ECH Wireless Configurations per Section 6.3.1.1, up until Step 8. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 92 of 101 Table 42 External Communications Hub Wireless Instructions 10. Device 2 is ready for wireless, unplug Device USB cable. Unplug HFC USB Cable 90 Type-C connector from the second HFC. 11. ECH notifies Hub Setup Complete Review the HFC Display Screen. 12. Connected Handheld Fluorescent Camera(s) will show ECH:

Connected Wifi in the top. 13. Press Enable Casting to cast the HFC Display Screen onto the ECH Display Monitor Wirelessly. 14. Verify the ECH Display Monitor is casting the HFC Display Screen. 6.3.2.3. ECH Wired Configuration Table 43 External Communications Hub Wired Instructions 1. Ensure the ECH has been assembled and is powered on according to section 6.3.2.1. 2. After ECH PC power on, enter authorization PIN on ECH Numeric Pad to login. 3. After successful login, the ECH Display Monitor shows the ECH Start Up screen. Shortly after, ECH prompts to Insert & Unlock USB Memory Stick. 4. Insert ECH Flash Drive into the ECH PC USB port and/or unlock encrypted ECH Flash Drive. 5. When ECH Flash Drive is unlocked and plugged into the ECH PC USB port, ECH notifies USB memory stick setup complete. 6. After successful login, ECH notifies Hub is ready for Wired setup Connect First Device. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 93 of 101 Table 43 External Communications Hub Wired Instructions 7. Before proceeding, ensure the Custom Sterile Sleeve (CSS) has been configured for ECH Wired Configurations per Section 6.3.1.2, up until Step 10. Connect ECH Link Cable to the ECH PC USB Port. 8. When a successful connection is made, ECH notifies First Device is connected to the Hub: wired. ECH notifies Hub is ready for Wireless setup Connect Second Device. 9. If not connecting two (2) HFCs, select Enter and move to the next step. If connecting two (2) HFCs, connect second ECH Link Cable into the ECH PC USB Port. 10. Second Device is connected to the Hub: wired. 11. ECH notifies Hub Setup Complete. Review the HFC Display Screen. 12. Connected Handheld Fluorescent Camera(s) will show ECH:

Connected USB in the top left corner. 13. Press Enable Casting to cast the HFC Display Screen onto the ECH Display Monitor Wirelessly. 14. Verify the ECH Display Monitor is casting the HFC Display Screen. 6.3.3. DIS Dark Imaging Sheet The DIS provides a black non-reflective, non-fluorescent standardized surface background imaging in the sterile field or with the Dark Imaging Box per Section 6.3.4. Table 44 Dark Imaging Sheet Instructions 1. When used in the sterile field, place the DIS on a flat surface with the side labelled This Side Down / Ce Ct En Bas facing down. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 94 of 101 Table 44 Dark Imaging Sheet Instructions 2. Place imaging specimen on the DIS and perform imaging per Section 6.2.2.2. When using the Dark Imaging Sheet with the Dark Imaging Box, place the DIS with imaging specimen on the DIB Imaging Tray with the side labelled This Side Down / Ce Ct En Bas facing down. Perform imaging per Section 6.2.2.2. 3. 6.3.4. DIB Dark Imaging Box The Dark Imaging Box is intended to be positioned on a flat surface in the non-sterile field. Table 45 Dark Imaging Box Instructions 1. Before use, clean and disinfect the Dark Imaging Box according to Section 5.3. 2. Position the Dark Imaging Box on a flat surface in the non-sterile field. 3. Pull the DIB Tray out in preparation of receiving the Dark Imaging Sheet. 4. Place the Dark Imaging Sheet into the DIB Tray recess, and push the DIB Tray in. 5. Enclose the Dark Imaging Box by aligning the DIB Covers around the Dark Imaging Box. The DIB Covers magnetize to the Dark Imaging Box. 6. Place the Handheld Fluorescent Camera into the DIB Cradle and perform imaging per Section 6.2.2.2. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 95 of 101 6.3.5. CCD Contact Charging Device The Handheld Fluorescence Camera is required to be fully charged before use. While charging, the device is inoperable with exception to reviewing acquired images and videos. While charging, connection to the ECH is not supported. Table 46 Charging Instructions 1. Before use, clean and disinfect the Contact Charging Device according to Section 5.3. Assemble the CCD Power supply and plug the USB Type-C connector into the CCD USB Type-C port. 2. Pug the CCD Power cord into electrical outlet. 3. The white LED on the front side of the Contact Charging Device is illuminated when power is supplied. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 96 of 101 Table 46 Charging Instructions 4. Place the Handheld Fluorescent Camera into the Contact Charging Cradle, with the HFC Optical Head pointing down. The HFC battery begins charging when the HFC makes contact with the two charging pins on the top side of the CCD. 5. 6. Refer to Section 6.2.1.3 for details on the Battery Status LED to understand how to determine battery charge levels, and battery charge status. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 97 of 101 6.3.6. PSC Protective Storage Cradle Use the Protective Storage Cradle to Safeguard the Handheld Fluorescence Camera when not in use or during transportation. Table 47 Charging Instructions 1. Before use, clean and disinfect the Protective Storage Cradle according to Section 5.5. 2. To protect the Handheld Fluorescent Camera, place the Protective Storage Cradle on a flat surface and open the Protective Storage Cradle lock. Place the Handheld Fluorescent Camera into the Protective Storage Cradle, with the HFC Optical Head pointing down. 3. Rest the HFC on the PSC cradle, and close the PSC lock. The HFC is now locked into the PSC. 4. To remove the HFC from the PSC, open the PSC lock and remove the HFC. PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 98 of 101 7. Workflow 7.1. Unpack 1) Unpack and remove all Eagle V1.2 Imaging System components. 2) Charge HFC with CCD per Section 6.3.5. 3) Set up the ECH per Section 6.3.2.1 and verify HFC connection. 7.2. Imaging Workflow 1) Clean, disinfect, and sterilize all Eagle V1.2 Imaging System components per Section 5. 2) Mount the CSS on the HFC per Section 6.3.1 3) Verify successful HFC connection with ECH per Section 6.3.2.2 or 6.3.2.3. 4) Perform imaging per Section 6.2.2.2 5) Use the Dark Imaging Sheet and Dark Imaging Box as necessary per Section 6.3.3 and Section 1) Dispose of CSS, DIS, and DIB Covers. 2) Clean, disinfect, and sterilize Eagle V1.2 Imaging System components per Section 5. 6.3.4. 7.3. Post Imaging 8. Care and Maintenance 8.1. Transport and Handling Per section 6.3.6 Store the Handheld Fluorescent Camera in the Protective Storage Cradle when not in use. 9. Performance Specifications 9.1. HFC Handheld Fluorescence Camera Operating Temperature:

Operating Relative humidity:

Operating Atmospheric pressure:

Height:

Width:

Depth:

Weight:

Battery Capacity:

Operating Voltage:

Input (Charging Current, Voltage):

18 25 C 10 70%

89 102 kPa 13 cm 19 cm 13 cm 591 g 2.5 A, 5 VDC 6500 mAh 3.7 VDC PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 99 of 101 9.2. CSS Custom Sterile Sleeve FCC ID:

ISED ID:

Operating Temperature:

Operating Relative humidity:

Operating Atmospheric pressure:

Height:

Width:

Depth:

9.3. ECH External Communications Hub 2AFDI ITCOQ626S 9049A ITCOQ626S 18 25 C 10 70%

89 102 kPa 2 cm 28 cm 39 cm Operating Temperature:

Operating Relative humidity:

Operating Atmospheric pressure:

RAM:

Memory:

Operating System:

FCC ID:

WLAN:

9.3.1. ECH PC Power Supply 9.3.2. ECH Router Power Supply Output:

Output:

Output:

Frequency:

Wi-Fi Speed:

Wi-Fi:

9.3.3. DVI Link Power Supply 9.3.4. ECH Router Wireless 9.4. CCD Contact Charging Device Operating Temperature:

Operating Relative humidity:

Operating Atmospheric pressure:

Height:

Width:

Depth:

Weight:

Output Current:

Output Voltage:

18 25 C 10 70%

89 102 kPa 8 GB 256 GB Windows 10 ZJEST-WKP302 2.4 GHz 65 W, 19 V, 3.40 A 6 W, 12 V, 1.0 A 10 W, 5 V, 2.0 A 5.0 GhZ AC2200 AC4400 802.11AC 18 25 C 10 70%

89 102 kPa 15 cm 18 cm 15 cm 400 g 2.5 A 5 V PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 100 of 101 END OF Eagle V1.2 Imaging System Instructions for Use PN 10232 Eagle V1.2 Instructions for Use Rev 1.0 Page 101 of 101

Open-QTM 626 SOM Module Certification Technical Note OEM Integrator Guide Part Number APP-0070 Revision A September 2020 Your use of this document is subject to and governed by those terms and conditions in the LICENSE AND PURCHASE TERMS AND CONDITIONS FOR INTRINSYC DEVELOPMENT PLATFORM KITS, which you or the legal entity you represent, as the case may be, accepted and agreed to when purchasing a Development Kit from Intrinsyc Technologies Corporation (Agreement). You may use this document, which shall be considered part of the defined term Documentation for purposes of the Agreement, solely in support of your permitted use of the Development Kit under the Agreement. Distribution of this document is strictly prohibited without the express written permission of Intrinsyc Technologies Corporation and its respective licensors, which they can withhold, condition or delay in its sole discretion. Lantronix is a trademark of Lantronix, Inc., registered in the United States and other countries. Intrinsyc is a trademark of Intrinsyc Technologies Corporation, registered in Canada and other countries. Qualcomm is a trademark of Qualcomm Incorporated, registered in the United States and other countries. Other product and brand names used herein may be trademarks or registered trademarks of their respective owners. This document contains technical data that may be subject to U.S. and international export, re-export, or transfer (export) laws. Diversion contrary to U.S. and international law is strictly prohibited. 2020 Lantronix, Inc. All rights reserved. Contacts Lantronix, Inc. 7535 Irvine Center Drive, Suite 100 Irvine, CA 92618, USA Toll Free: 800-526-8766 Phone: 949-453-3990 Fax: 949-453-3995 IES Customer Support Portal https://helpdesk.intrinsyc.com Lantronix Technical Support http://www.lantronix.com/support Sales Offices For a current list of our domestic and international sales offices, go to the Lantronix web site at http://www.lantronix.com/about-us/contact/

Open-Q 626 SOM Module Certification OEM Integrator Guide 2 Revision History Date Rev. Comments March 2019 May 2019 1.0 1.1 September 2020 A Initial release. Intrinsyc document number: ICS-01RND1278-TN-068 Corrected typo on Title page and changed formatting of Allowable Antennas section, updated Antenna Gain in Antenna Information for Industry Canada and added 5GHz statement in FCC Interference Statement and Industry Canada Statements. Removed duplicate Antenna information on page 10 that is already on page 4. Initial Lantronix document. Added Lantronix document part number, Lantronix logo, branding, contact information, and links. For the latest revision of this product document, please go to: http://tech.intrinsyc.com. Note: The Lantronix Open-QTM 626 SOM radio module (the Module) is certified for compliance for use in the USA and Canada only. For use in other countries, certificates of compliance must be obtained for that country or region before the module can be sold, operated or incorporated into products. In addition, any deviation from the settings, methods, conditions and restrictions for integration of the Module into a host system, as defined in this document, could be a violation of applicable national law and may be punishable as such, and in such event, the products into which the Module is incorporated may not be lawfully distributed or sold in such countries. Lantronix assumes no responsibility for any such liability or loss related to installation or operation of the Module. Open-Q 626 SOM Module Certification OEM Integrator Guide 3 5 6 7 8 9 10 11 12 Contents 1 Introduction 2 Applicable Module Contacts _____________________________________________________________ 2 Revision History _______________________________________________________ 3 3 Additional Regulatory Conformance Testing and/or Submissions Required by the Integrator 4 Compliant/Allowable Tx Power Settings 5 Allowable Antennas to use with the Radio Module 6 Antenna Placement and RF Safety 7 Simultaneous Transmission with other Integrated or Plug-

in Radios 8 Module May Not Be Installed by End Users 9 Required Labeling on the Outside of the Host 13 FCC Labeling Requirements on the Outside of the Host _________________ 13 Industry Canada Labeling Requirements on the Outside of the Host ________ 13 9.1 9.2 10 Required Labeling on the Module 15 10.1 FCC and Industry Canada Labeling on the Module _____________________ 15 11 Required Regulatory Wording for End User Manual /

Installation Manual 16 11.1 FCC Requirements for End User Manual / Installation Manual ____________ 16 11.2 Industry Canada Requirements for End User Manual / Installation Manual ___ 17 12 OEM Integrator Checklist 21 Open-Q 626 SOM Module Certification OEM Integrator Guide 4 1 Introduction This document describes the steps that the OEM integrator must follow when designing and manufacturing a system utilizing the Open-QTM 626 SOM Transmitter Module. Failing to follow the instructions in this document may invalidate the FCC and IC (Industry Canada) certifications and authorizations of the Module for use in the U.S. and Canada. The Module certifications described in this document apply only to radio conformance for the Module. The OEM integrator is responsible for all system-level EMI/EMC and Product Safety testing and certifications that apply to the host system in the U.S. and other countries where the system will be marketed or sold. Open-Q 626 SOM Module Certification OEM Integrator Guide 5 2: Applicable Module 2 Applicable Module Model USA/FCC CANADA/IC Open-QTM 626 SOM 2AFDI-ITCOQ626S 9049A-ITCOQ626S Open-Q 626 SOM Module Certification OEM Integrator Guide 6 3: Additional Regulatory Conformance Testing and/or Submissions Required by the Integrator 3 Additional Regulatory Conformance Testing and/or Submissions Required by the Integrator The modular certifications apply to the radio conformance for the Module only. The OEM integrator is responsible for additional system-level EMI/EMC and Product Safety testing and certification that applies in the U.S. and other countries to the host system containing the Module. This includes but is not limited to Federal Communications Commission (FCC) Part 15 Class B Digital Emissions. These system-level EMC tests are to be done with the Module installed and included in the scope of the submission. Some of the countries for which modular certifications are provided require additional submissions, authorizations or import permission by the system-vendor or importer. The integrator is responsible for these additional actions. Modular radio certification is not possible in some countries. For such countries, OEM integrators must ensure radio certification for the end system is obtained, before placing the product on the market. Open-Q 626 SOM Module Certification OEM Integrator Guide 7 4 Compliant/Allowable Tx Power Settings 4: Compliant/Allowable Tx Power Settings Any adjustments made to increase transmit power settings will invalidate all radio certifications for this module. Open-Q 626 SOM Module Certification OEM Integrator Guide 8 5 Allowable Antennas to use with the Radio 5: Allowable Antennas to use with the Radio Module The module is certified for use with certain antennas as described in this section. Module Allowed Antenna Types:

1. Dipole antenna Table 1 Allowed Maximum Gain (dBi) Dipole, Including Cable Loss 2.4~2.5GHz 4.9~5.8GHz 3.32 6.11 The required antenna impedance is 50 ohms. Use of other antenna types or the same type of antenna but with higher gain than listed above is not allowed without additional testing and appropriate FCC or IC approval. Use of a similar antenna may only require a C1PC to confirm the performance for SAR is the same or better (i.e. lower) but only an equivalent antenna can be used without any additional testing. Open-Q 626 SOM Module Certification OEM Integrator Guide 9 6 Antenna Placement and RF Safety 6: Antenna Placement and RF Safety The FCC and other countries regulatory bodies impose strict conditions and limitations on the RF exposure levels of end products. Acceptable RF exposure levels for this Module depend on transmit power, the location of the transmitting antenna(s) inside the host system and the expected separation of the transmitting antennas to the end user. OEM integrators must take great care to ensure each host system complies with the applicable RF exposure requirements. The antenna-to-user (bystander) separation distance must be greater than 20 cm. Failure to adhere to these separation/spacing rules will invalidate the FCC and IC certifications for the Module. This separation is measured between the closest point of each transmitting antenna inside the host device to the point of contact by the user or nearby person outside the host device. For notebooks/netbooks/laptops with antennas in display section, the LCD is opened 90 degrees/perpendicular to the keyboard. The separation distance is then measured from the nearest point of each transmitting antennas to the bottom of the host. Use in the keyboard section of a netbook or laptop or use in a tablet device or convertible tablet would require host-specific testing. For notebooks/netbooks/laptops, the transmitting antenna cables shall be positioned away from the antenna elements to conform to the configuration tested for compliance. When transmitting antennas are installed in the display section of notebook/netbook/laptops, the display section shall not have metallic components and material that can influence or change the operating and RF exposure characteristics of the antennas. The separation between the main and aux antennas must be at least 3 cm. The transmitter module may not be co-located with any other transmitter or antenna. SAR evaluation is required if the separation distance between the user or bystanders and the device is less than or equal to 20 cm. Where one or more of the conditions above cannot be met for a particular host system, additional testing is required to secure the necessary certifications for the system. Note: These restrictions do not apply to receive-only antenna. Open-Q 626 SOM Module Certification OEM Integrator Guide 10 7: Simultaneous Transmission with other Integrated or Plug-in Radios 7 Simultaneous Transmission with other Integrated or Plug-in Radios The FCC and IC impose conditions and limitations when additional radio(s) are co-located in the same host system as the Module with capability to transmit simultaneously. Co-locating other radios such as an integrated or plug in Wireless WAN/cellular radio with the Module requires additional evaluation and possibly submission for authorization from the FCC and IC. Because the rules are highly dependent on the characteristics of the particular radios that are co-located and simultaneously transmitting, the OEM integrator should seek guidance from a knowledgeable test lab or consultant to determine if additional testing and certification is required. In this case, failure to evaluate and follow the required FCC and IC procedures will invalidate the FCC and IC certifications of the Module and end system. Open-Q 626 SOM Module Certification OEM Integrator Guide 11 8 Module May Not Be Installed by End Users 8: Module May Not Be Installed by End Users FCC and IC rules require this Module to be installed in host systems at the factory by the OEM integrator. Thus, end users of the system may not install the Module. Therefore, the host product user instructions must not advise the end user on how to access or remove the Module. Additional FCC authorization/filing is needed to allow end user installation of the radio modules. If modules are provided to the end users for installation in the host, a two-way authentication protocol is required to limit the module to operate only with the authorized host system. Open-Q 626 SOM Module Certification OEM Integrator Guide 12 9 Required Labeling on the Outside of the Host 9: Required Labeling on the Outside of the Host 9.1 FCC Labeling Requirements on the Outside of the Host The FCC requires a label on the outside of the host system visible to the end user. Example wording is:

Contains:

FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S The FCC requires a logo signifying emission compliance on the outside of the host system. The OEM integrator is responsible to perform FCC Part 15 Class B digital emissions testing on the end system with the radio Module installed. The FCC logo below should not be affixed unless the OEM integrator has obtained the necessary Part 15 approval, e.g., self-declaration of conformity. If the host system is approved to FCC Class B digital emissions limits under a grant of certification issued by a TCB, the FCC ID number shown on the grant should be used on the label instead of the FCC logo below. Also see https://www.fcc.gov/logos. A certified modular has the option to use a permanently affixed label, or an electronic label (Refer to FCC KDB 784748 D02 e labeling for e-labelling guidance). All modules without an integrated display on the module must be labelled with a modules FCC ID - Section 2.926. 9.2 Industry Canada Labeling Requirements on the Outside of the Host Open-Q 626 SOM Module Certification OEM Integrator Guide 13 9: Required Labeling on the Outside of the Host End Product Labeling The final end product must be labeled in a visible area with the following for the Open-QTM 626 SOM: Contains IC: 9049A-ITCOQ626S. Plaque signaltique du produit final Le produit final doit tre tiquet dans un endroit visible avec l'inscription suivante:

Open-QTM 626 SOM: Contient des IC: 9049A-ITCOQ626S. Open-Q 626 SOM Module Certification OEM Integrator Guide 14 10 Required Labeling on the Module 10: Required Labeling on the Module 10.1 FCC and Industry Canada Labeling on the Module The OEM integrator must ensure that the FCC ID and IC number is affixed on the Module or in a User/Installation Manual along with other country certification numbers and logos as described herein. Note: the original Module manufacturer may affix regulatory labeling at time of Module manufacturing. However, the OEM integrator must ensure that Module labeling is complete, correct, and applicable for all the countries to which the host system is to be imported, marketed, or sold. Open-Q 626 SOM Module Certification OEM Integrator Guide 15 11: Required Regulatory Wording for End User Manual /

Installation Manual 11 Required Regulatory Wording for End User Manual / Installation Manual 11.1 FCC Requirements for End User Manual / Installation Manual The OEM integrator must provide instructions in the end user manual how to retrieve the module FCC ID for host devices using electronic labeling (for example an integrated display) in lieu of a physical label or nameplate to meet the labelling requirements of Industry Canada (Refer to FCC KDB 784748 D02 e labeling document for guidance). The OEM integrator must include text in the end user manual (meeting the regulators requirements. When the module is installed inside another device, the user manual of that device must contain the statements and warnings below (text in red font must be replaced):

FEDERAL COMMUNICATIONS INTERFERENCE STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This product does not contain any user serviceable components. Any unauthorized product changes or modifications will invalidate warranty and all applicable regulatory certification and approvals, including authority to operate this device. FCC Part 15 Digital Emissions Compliance We [System Manufacturer Name, Address, Telephone], declare under our sole responsibility that the product [System Name] complies with Part 15 Rules. Operation is subject to the following two conditions:

(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. WARNING: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates and radiates radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. Open-Q 626 SOM Module Certification OEM Integrator Guide 16 11: Required Regulatory Wording for End User Manual /

Installation Manual However there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from the one the receiver is connected to. Consult the dealer or an experienced radio or TV technician for help.

(Notice for 5GHz and/or when co-located with 5GHz transmitters, the following statements should be provided for user information.) Operations in the 5.15-5.25GHz band are restricted to indoor usage only. (For 5GHz only) IMPORTANT! Changes or modifications not expressly approved by [System Manufacturer Name]

could void the users authority to operate the equipment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. FCC RF Exposure Requirements:

This product complies with the FCC RF exposure limit set forth for an uncontrolled environment and is safe for intended operation as described in this manual. This device is only authorized for use in a mobile application, at least 20 cm of separation distance between the radiating antenna and the user's body must be maintained at all times. Further RF exposure reduction can be achieved if the product can be kept as far as possible from the users body or set the device to a lower output power if such a function is available. Separate approval is required for all other operating configurations, including portable configurations with respect to 47 CFR Part 2.1093 and different antenna configurations. 11.2 Industry Canada Requirements for End User Manual /

Installation Manual Industry Canada Statements This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:

Open-Q 626 SOM Module Certification OEM Integrator Guide 17

(1) This device may not cause interference, and (2) This device must accept any interference, including interference that may cause undesired operation of the device. 11: Required Regulatory Wording for End User Manual /

Installation Manual Le prsent appareil est conforme aux CNR dIndustrie Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes:

(1) lappareil ne doit pas produire de brouillage;

(2) lutilisateur de lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement.

(Notice for 5GHz and/or when co-located with 5GHz transmitters, the following statements should be provided for user information.) Caution:

(i) the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for harmful interference to co-channel mobile satellite systems;

(ii) the maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 5470-5725 MHz shall comply with the e.i.r.p. limit; and

(iii) the maximum antenna gain permitted for devices in the bands 5725-5825 MHz shall comply with the e.i.r.p. limits specified for point-to-point and non point-to-point operation as appropriate.

(iv) Users should also be advised that high power radars are allocated as primary users (i.e. priority users) of the bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices Avertissement:

Le guide d'utilisation des dispositifs pour rseau-x locaux doit Inclure des instructions pccises su:r les restrictions susmentionnes, notamment:

(i) les dispositifs fonctionnant dans la bande 5150-5250 MHz sont rservs uniquement pour une utilisation intrieur afin de rduire les risques de brouillage prjudiciable aux systmes de satellites mobiles utilisant les mmes canaux;

(ii) le gain maximal dantenne permis pour les dispositifs utilisant les bandes 5150-5250 MHz et 5470-5725 MHz doit se conformer la limite de p.i.r.e.;

Open-Q 626 SOM Module Certification OEM Integrator Guide 18 11: Required Regulatory Wording for End User Manual /

Installation Manual

(iii) le gain maximal d'antenne permis (pour les dispositifs utilisant la bande 57255825 MHz) doit se conformer la limite de p.i.r.e. spcifie pour l'exploitation point point et non point point, selon le cas.

(iv) De plus, les utilisateurs devraient aussi tre aviss que les utilisateurs de radars de haute puissance sont dsigns utilisateurs principaux (c.--d ., qu'ils ont la priorit) pour les bandes 5250-5350 MHz et 5650-5850 MHz et que ces radars pourraient causer du brouillage et/ou des dommages aux dispositifs LAN-EL. Radiation Exposure Statement This equipment complies with radiation exposure limits set forth for uncontrolled environment. The antenna(s) used for this transmitter must be installed to provide a separation distance of at least 20 cm from all persons and must not be collocated or operating in conjunction with any other antenna or transmitter. Dclaration d'exposition aux radiations Cet appareil se conforme aux limites d'exposition aux rayonnements pour un environnement non contrl. L'antenne (s) qui est utilis pour cet metteur doit tre install pour produire une distance de sparation d'au moins 20 cm de toutes personnes et ne doit pas tre install proximit ou utilis en conjonction avec une autre antenne ou metteur. This device is intended only for OEM integrators under the following conditions:

1. The antenna used will be of the same type and have an antenna gain which is the same or less than what is listed in this document. 2. The antenna must be installed such that 20 cm is maintained between the antenna and users. 3. The transmitter module may not be co-located with any other transmitter or antenna. As long as the conditions above are met, further transmitter tests will not be required. However, the OEM integrator is still responsible for testing the end product and any additional compliance requirements required with this module installed. Cet appareil est conu uniquement pour les intgrateurs OEM dans les conditions suivantes:

1. L'antenne utilise sera du mme type et aura un gain d'antenne identique ou infrieur ce qui est 2. L'antenne doit tre install de telle sorte que 20 cm est maintenue entre l'antenne et les indiqu dans ce document. utilisateurs. 3. Le module metteur peut ne pas tre co-localis avec un autre metteur ou antenne. Tant que les conditions ci-dessus sont remplies, d'autres tests d'mission ne seront pas ncessaires. Cependant, l'intgrateur OEM est toujours responsable pour tester le produit final et toutes les exigences de conformit supplmentaires ncessaires avec ce module install. Open-Q 626 SOM Module Certification OEM Integrator Guide 19 11: Required Regulatory Wording for End User Manual /

Installation Manual In the event that these conditions cannot be met, then the Canadian authorization is no longer considered valid and the IC ID cannot be used on the final product. In these circumstances, the OEM integrator will be responsible for re-evaluating the end product (including the transmitter) and obtaining a separate Canada authorization. Important Note:

Note Importante:

Dans le cas o ces conditions ne peuvent tre satisfaites, l'autorisation du Canada n'est plus considr comme valide et l'ID IC ne peut pas tre utilis sur le produit final. Dans ces circonstances, l'intgrateur OEM sera charg de rvaluer le produit final (y compris l'metteur) et l'obtention d'une autorisation distincte au Canada. Manual Information to the End User The OEM integrator has to be aware not to provide information to the end user regarding how to install or remove this RF module in the users manual of the end product which integrates this module. The end user manual shall include all required regulatory information/warning as shown in this manual. The OEM integrator must provide instructions in the end user manual how to retrieve the module IC number for host devices using electronic labeling (for example an integrated display) in lieu of a physical label or nameplate to meet the labelling requirements of Industry Canada (Refer to IC Notice 2014-

DRS1003 for guidance). Manuel d'information l'utilisateur final L'intgrateur OEM doit tre conscient de ne pas fournir des informations l'utilisateur final quant la faon d'installer ou de supprimer ce module RF dans le manuel de l'utilisateur du produit final qui intgre ce module. Le manuel de l'utilisateur final doit inclure toutes les informations rglementaires requises et avertissements comme indiqu dans ce manuel. L'intgrateur OEM doit fournir des instructions dans le manuel utilisateur expliquant comment rcuprer le numro IC du module pour les appareils htes en utilisant l'tiquetage lectronique (par exemple un cran intgr) en lieu et place d'une tiquette physique ou plaque signaltique pour rpondre aux exigences en matire d'tiquetage d'Industrie Canada (Se reporter la note d'IC 2014 - DRS1003 pour plus d'information). Open-Q 626 SOM Module Certification OEM Integrator Guide 20 12 OEM Integrator Checklist 12: OEM Integrator Checklist The OEM Integrator will integrate the Module in the host systems in accordance with the instruction specified in this document and the documents referenced herein. The OEM Integrator will ensure the Module is integrated in a host system using only antennas that are of the same type and having equal or less antenna gain as described in this document. The OEM Integrator will ensure the antennal placement inside the host system will maintain the required spacing to the end user for RF Exposure compliance, as specified in this document. If other radios are integrated inside the host with the Module, the OEM Integrator will contact a test lab or TCB to determine if additional FCC compliance evaluation is required to meet FCC collocation rules. The OEM Integrator will ensure end user documentation will contain the specified regulatory wording and ensure the host system and the Module itself is labeled as specified in this document. The OEM Integrator will ensure that nothing is done that will change the transmit power level of the module. The OEM Integrator will ensure end user documentation will contain clear instructions on how to access the FCC ID and IC Number of the module should an electronic display (e-labeling) be used to meet the FCC and IC labeling requirements (Refer to FCC KDB 784748 D02 e labeling document and IC Notice 2014-DRS1003 for guidance). Open-Q 626 SOM Module Certification OEM Integrator Guide 21

FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Host Moleculight Device Label Location (bottom of unit) FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Below is Draft design of the Label Host Device Moleculight FCC and IC Label FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Host SBI Device Label Location (back of unit) FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Host Device SBI FCC and IC Label FCC ID: 2AFDI-ITCOQ626S IC: 9049A-ITCOQ626S Model: Open-QTM 626 SOM Transmitter Module FCC and IC Label Location Top Side Drawing of Module with Label Dimensions (mm).

LANTRONIX uthori Act as Agent Date: 12/18/2020 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern:

RF Exposure Lab is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. This authorization is applicable to the product:

FCC ID: 2AFDI-ITCOQ626S Agency Agreement Expiration Date: 1/31/2021 Sincerely,

By: Fathi Hakam

(Signature) Title: VP of Engineering On behalf of: Lantronix Telephone: (949) 453-3990 Fax: (949) 453-3995 e-mail: fhakam@lantronix.com LANTRONIX 7535 Irvine Center Drive, Suite 100 Irvine, CA 92618 USA Telephone: +1 (949) 453-3990 Fax No: +1 (949) 453-3995 Lantronix.com

LANTRONIX Date: 12/18/2020 Subject: Confidentiality Request for FCC ID: 2AFDI-ITCOQ626S Pursuant to FCC 47 CRF 0.457(d) the applicant requests that a part of the subject FCC application be held confidential.

[_] Short Term Tune Up Procedure Type of exhibit Operation Description/Theory of Operation Lantronix has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Sincerely, By: Fathi Hakam Title: VP of Engineering On behalf of: Lantronix Telephone: (949) 453-3990 Fax: (949) 453-3995 e-mail: fhakam@lantronix.com LANTRONIX 7535 Irvine Center Drive, Suite 100 Irvine, CA 92618 USA Telephone: +1 (949) 453-3990 Fax No: +1 (949) 453-3995 Lantronix.com

SPECIFICATION Patent Pending Part No.

: FXP.830.07.0100C Product Name : FXP.830 Freedom Wi-Fi 2.4/5 GHz Dipole Antenna Features

: Very High Efficiency Ground-plane Independent IPEX MHF1 Connector (U.FL compatible) RoHS Compliant SPE-11-8-037/F/SS Page 1 of 14 1. Introduction The FXP.830 has a peak gain of 1.8dBi at 2.4GHz and efficiencies of 50%, and 3-4dBi and 80-90% along bands 4.9GHz to 6GHz. The FXP830 is a high efficiency, small, dual-band, dipole antenna for 2.4/4.9-6GHz band including Bluetooth and Wi-Fi. This Taoglas patent pending antenna is unique in the market because it is made from poly-flexible material, has a tiny form factor

(42*7*.01mm) and has double-sided 3M tape for easy peel and stick mounting. The FXP.830 is the ideal all-round antenna solution for squeezing into narrow spaces and still maintaining high performance, for example at the top of LCD devices. Many module manufacturers specify peak gain limits for any antennas that are to be connected to that module. Those peak gain limits are based on free-space conditions. In practice, the peak gain of an antenna tested in free-space can degrade by at least 1 or 2dBi when put inside a device. So ideally you should go for a slightly higher peak gain antenna than mentioned on the module specification to compensate for this effect, giving you better performance. Upon testing of any of our antennas with your device and a selection of appropriate layout, integration technique, or cable, Taoglas can make sure any of our antennas peak gain will be below the peak gain limits. Taoglas can then issue a specification and/or report for the selected antenna in your device that will clearly show it complying with the peak gain limits, so you can be assured you are meeting regulatory requirements for that module. SPE-11-8-037/F/SS Page 2 of 14 For example, a module manufacturer may state that the antenna must have less than 2dBi peak gain, but you dont need to select an embedded antenna that has a peak gain of less than 2dBi in free-space. This will give you a less optimized solution. It is better to go for a slightly higher free-space peak gain of 3dBi or more if available. Once that antenna gets integrated into your device, performance will degrade below this 2dBi peak gain due to the effects of GND plane, surrounding components, and device housing. If you want to be absolutely sure, contact Taoglas and we will test. Choosing a Taoglas antenna with a higher peak gain than what is specified by the module manufacturer and enlisting our help will ensure you are getting the best performance possible without exceeding the peak gain limits. SPE-11-8-037/F/SS Page 3 of 14 2. Specification Frequency Peak Gain (free space) Peak Gain (on plastic*) Average Gain (free space) Average Gain (on plastic) Efficiency (free space) Efficiency (on plastic) Polarization Impedance Radiation Pattern Input Power Dimensions Antenna Body Material Cable Connector Temperature Range Humidity ELECTRICAL 2.4 ~ 2.5GHz, 2.55dBi 3.32dBi

-3.0dBi

-3.0dBi 50%

50%

4.9 ~ 5.8GHz 4.66dBi 6.11dBi

-0.6dBi

-0.7dBI 86%

84%

Linear 50 Ohms Omnidirectional 2W max. MECHANICAL 42*7mm Polymer Ipex MHF Gray 100mm 1.37 co-axial ENVIRONMENTAL

-40C to 85C Non-condensing 65C 95% RH

* FXP.830 is likely to be mounted on plastic in many applications so we provide the antenna measurement in both free space and mounted on a 1mm thick plastic. SPE-11-8-037/F/SS Page 4 of 14 3. Antenna Characteristics 3.1. Return Loss 2000 2500 3000 3500 4000 4500 5000 5500 6000 (MHz) 3.2. VSWR

) B d

-15 0

-5

-10

-20

-25

-30 10 9 8 7 6 5 4 3 2 free space on plastic free space on plastic 1 2000 2500 3000 3500 4000 4500 5000 5500 6000 (MHz) SPE-11-8-037/F/SS Page 5 of 14 3.3. Antenna Efficiency 100 90 80 70 60 50 40 30 20 10

0 2300 100 90 80 70 60 50 40 30 20 10

0 4900 2350 2400 2450 2500 2550 2600 free space on plastic

(MHz) free space on plastic

(MHz) 5000 5100 5200 5300 5400 5500 5600 5700 5800 5900 SPE-11-8-037/F/SS Page 6 of 14 3.4. Antenna Peak Gain 5 4 3 2 1 7 6 5 4 3 2 1

) i B d

) i B d

0 2300 2350 2400 2450 2500 2550 2600

(MHz) free space on plastic free space on plastic 0 4900 5000 5100 5200 5300 5400 5500 5600 5700 5800 5900

(MHz) SPE-11-8-037/F/SS Page 7 of 14 3.5. Antenna 3D Average Gain

) i B d

0.0

-1.0

-2.0

-3.0

-4.0

-5.0

) i B d

-1.0 1.0 0.5 0.0

-0.5

-1.5

-2.0

-2.5

-3.0 2300 2350 2400 2450 2500 2550 2600

(MHz) free space on plastic free space on plastic 4900 5000 5100 5200 5300 5400 5500 5600 5700 5800 5900

(MHz) SPE-11-8-037/F/SS Page 8 of 14 3.6. Radiation Pattern for FXP.830 on plastic X Z Y SPE-11-8-037/F/SS Page 9 of 14 XY Plane 0 345 350355 5 5 10 15 340 335 330 325 20 25 30 35 40 205 200 195 155 160 165 190 185 175 170 180 130 135 140 145 150 2.45GHz 5.0GHz 5.8GHz XZ Plane 340 335 330 325 320 315 310 0 345 350 355 5 5 10 15 20 25 30 35 40 45 0

-5

-10

-15

-20

-25

-30

-35 0

-5

-10

-15

-20

-25

-30

-35 320 315 310 305 300 295 290 285 280 275 270 265 260 255 250 245 240 235 230 225 220 215 210 305 300 295 290 285 280 275 270 265 260 255 250 245 240 235 230 225 220 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 215 210 205 200 195 190 185 175 170 180 130 135 140 145 150 155 160 165 2.45GHz 5.0GHz 5.8GHz SPE-11-8-037/F/SS Page 10 of 14 3.7. Free Space Radiation XY Plane 0 345350355 5 5 10 15 340 335 330 325 320 315 20 25 30 35 40 45 XZ Plane 225 220 215 210 205 200 195 155 160 165 190 185 175 170 180 135 140 145 150 2.45GHz 5.0GHz 5.8GHz 0 345 350 355 5 340 5 10 15 20 0

-5

-10

-15

-20

-25

-30

-35 0

-5

-10

-15

-20

-25

-30

-35 310 305 300 295 290 285 280 275 270 265 260 255 250 245 240 235 230 335 330 325 320 315 310 305 300 295 290 285 280 275 270 265 260 255 250 245 240 235 230 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 225 220 215 210 205 200 195 135 140 145 2.45GHz 5.0GHz 5.8GHz 150 155 160 165 190 185 175 170 180 SPE-11-8-037/F/SS Page 11 of 14 4. Antenna Drawing SPE-11-8-037/F/SS Page 12 of 14 5. Packaging SPE-11-8-037/F/SS Page 13 of 14 Taoglas makes no warranties based on the accuracy or completeness of the contents of this document and reserves the right to make changes to specifications and product descriptions at any time without notice. Taoglas reserves all rights to this document and the information contained herein. Reproduction, use or disclosure to third parties without express permission is strictly prohibited. Copyright Taoglas Ltd. SPE-11-8-037/F/SS Page 14 of 14

Date: November 20, 2020 Request for Modular Approval Subject: Manufacturers Declaration for - Modular Approval

- Split Modular Approval

- Limited Modular Approval - Limited Split Modular Approval Confidentiality Request for: ______2AFDI-ITCOQ626S______ For Items Marked NO(*), the Limited Module Description Must be Filled Out on the Following Pages Modular Approval Requirement Requirement Met 8 Basic Requirements FCC Part 15.212(a)(1) 1. The modular transmitter must have its own RF shielding. This is intended to ensure that the module does not have to rely upon the shielding provided by the device into which it is installed in order for all modular transmitter emissions to comply with FCC limits. It is also intended to prevent coupling between the RF circuitry of the module and any wires or circuits in the device into which the module is installed. Such coupling may result in non-compliant operation. The physical crystal and tuning capacitors may be located external to the shielded radio elements. 15.212(a)(1)(i)

- YES - NO(*) Details: The module contains a metal shield which covers all RF components and circuitry. The shield is located on the top side of the board. See photo provided with this application. 2. The modular transmitter must have buffered modulation/data inputs (if such inputs are provided) to ensure that the module will comply with FCC requirements under conditions of excessive data rates or over-modulation. 15.212(a)(1)(ii)

- YES - NO(*) Details: Data to the modulation circuit is buffered on the module; please refer to the operational description document filed with this application for full description. 3. The modular transmitter must have its own power supply regulation on the module. This is intended to ensure that the module will comply with FCC requirements regardless of the design of the power supplying circuitry in the device into which the module is installed. 15.212(a)(1)(iii)

- YES - NO(*) Details: The module contains its own power supply regulation and the rf reference oscillator is contained within the module. Please refer to the schematics and operational description documents filed with this application for full description. 4. The modular transmitter must comply with the antenna and transmission system requirements of 15.203, 15.204(b), 15.204(c), 15.212(a), and 2.929(b). The antenna must either be permanently attached or employ a unique antenna coupler (at all connections between the module and the antenna, including the cable). The professional installation provision of 15.203 is not applicable to modules but can apply to limited modular approvals under paragraph 15.212(b). 15.212(a)(1)(iv)

- YES - NO(*) Details: The module connects to its antenna via using an UFL type connector. This antenna connector is a non-standard connector. The antenna tested was a PIFA type and the data sheet is included in the application. 5. The modular transmitter must be tested in a stand-alone configuration, i.e., the module must not be inside another device during testing. This is intended to demonstrate that the module is capable of complying with Part 15 emission limits regardless of the device into which it is eventually installed. Unless the transmitter module will be battery powered, it must comply with the AC line conducted requirements found in Section 15.207. AC or DC power lines and data input/output lines connected to the module must not contain ferrites, unless they will be marketed with the module (see Section 15.27(a)). The length of these lines shall be length typical of actual use or, if that length is unknown, at least 10 centimeters to insure that there is no coupling between the case of the module and supporting equipment. Any accessories, peripherals, or support equipment connected to the module during testing shall be unmodified or commercially available (see Section 15.31(i)). 15.212(a)(1)(v)

- YES - NO(*) Details: Test data contained in this application is for the device tested as a stand-alone device connected externally to a PC. See test set-up photographs filed with this application. 6. The modular transmitter must be labeled with its own FCC ID number, or use an electron display

(see KDB Publication 784748). Modular Approval Requirement Requirement Met If using a permanently affixed label with its own FCC ID number, if the FCC ID is not visible when the module is installed inside another device, then the outside of the device into which the module is installed must also display a label referring to the enclosed module. This exterior label can use wording such as the following: Contains Transmitter Module FCC ID: XYZMODEL1 or Contains FCC ID: XYZMODEL1. Any similar wording that expresses the same meaning may be used. The Grantee may either provide such a label, an example of which must be included in the application for equipment authorization, or, must provide adequate instructions along with the module which explain this requirement. In the latter case, a copy of these instructions must be included in the application for equipment authorization. If the modular transmitter uses an electronic display of the FCC identification number, the information must be readily accessible and visible on the modular transmitter or on the device in which it is installed. If the module is installed inside another device, then the outside of the device into which the module is installed must display a label referring to the enclosed module. This exterior label can use wording such as the following: Contains FCC certified transmitter module(s). Any similar wording that expresses the same meaning may be used. The user manual must include instructions on how to access the electronic display. A copy of these instructions must be included in the application for equipment authorization. 15.212(a)(1)(vi)

- YES - NO(*) Details: The module is appropriately labeled (refer to the label and label location drawings contained within this application). Information to the integrator of this device regarding the labeling requirements for the host system is contained in the instructions provided with the module. 7. The modular transmitter must comply with all specific rule or operating requirements applicable to the transmitter, including all the conditions provided in the integration instructions by the grantee. A copy of these instructions must be included in the application for equipment authorization. For example, there are very strict operational and timing requirements that must be met before a transmitter is authorized for operation under Section 15.231. For instance, data transmission is prohibited, except for operation under Section 15.231(e), in which case there are separate field strength level and timing requirements. Compliance with these requirements must be assured. 15.212(a)(1)(vii)

- YES - NO(*) Details: The module complies with FCC Part 15C requirements. Instructions to the OEM installer are provided in the installation manual filed with this application.>

8. The modular transmitter must comply with any applicable RF exposure requirements. For example, FCC Rules in Sections 2.1091, 2.1093 and specific Sections of Part 15, including 15.319(i), 15.407(f), 15.253(f) and 15.255(g), require that Unlicensed PCS, UNII and millimeter wave devices perform routine environmental evaluation for RF Exposure to demonstrate compliance. In addition, spread spectrum transmitters operating under Section 15.247 are required to address RF Exposure compliance in accordance with Section 15.247(b)(4). Modular transmitters approved under other Sections of Part 15, when necessary, may also need to address certain RF Exposure concerns, typically by providing specific installation and operating instructions for users, installers and other interested parties to ensure compliance. 15.212(a)(1)(viii)

- YES - NO(*) Details: The module meets the requirements for a mobile/portable device that may be used at separation distances of more than 12mm from the human body. Refer to the RF Exposure test report submitted with this application. Limited Module Description When Applicable

* If a module does NOT meet one or more of the above 8 requirements, the applicant may request Limited Modular Approval (LMA). This Limited Modular Approval (LMA) is applied with the understanding that the applicant will demonstrate and will retain control over the final installation of the device, such that compliance of the end product is always assured. The operating condition(s) for the LMA; the module is only approved for use when installed in devices produced by grantee. A description regarding how control of the end product, into which the module will be installed, will be maintained by the applicant/manufacturer, such that full compliance of the end product is always ensured should be provided here. Details: N/A Details: N/A Details: N/A Software Considerations KDB 594280 / KDB 442812 (One of the following 2 items must be applied) Requirement Requirement Met 1. For non-Software Defined Radio transmitter modules where software is used to ensure compliance of the device, technical description must be provided about how such control is implemented to ensure prevention of third-party modification; see KDB Publication 594280.

- Provided in Separate Cover Letter

- N/A Details: <example The firmware of the device cannot be modified or adjusted by the end user as described in a separate cover letter filed with this application. >

2. For Software Defined Radio (SDR) devices, transmitter module applications must provide a software security description; see KDB Publication 442812.

- Provided in Separate Cover Letter

- N/A Split Modular Requirements Requirement Provided in Manual 1. For split modular transmitters, specific descriptions for secure communications between front-end and control sections, including authentication and restrictions on third-party modifications; also, instructions to third-party integrators on how control is maintained.

- Provided in Separate Cover Letter

- N/A OEM Integration Manual Guidance KDB 996369 D03 Section 2 Clear and Specific Instructions Describing the Conditions, Limitations, and Procedures for third-parties to use and/or integrate the module into a host device. Requirement Is this module intended for sale to third parties?

- YES

- No, If No, and LMA applies, the applicant can optionally choose to not make the following detailed info public. However there still needs to be basic integration instructions for a users manual and the information below must still be included in the operational description. If the applicant wishes to keep this info confidential, this will require a separate statement cover letter explaining the module is not for sale to third parties and that integration instructions are internal confidential documents. Items required to be in the manual See KDB 996369 D03, Section 2 As of May 1, 2019, the FCC requires ALL the following information to be in the installation manual. Modular transmitter applicants should include information in their instructions for all these items indicating clearly when they are not applicable. For example information on trace antenna design could indicate Not Applicable. Also if a module is limited to only a grantees own products and not intended for sale to third parties, the user instructions may not need to be detailed and the following items can be placed in the operational description, but this should include a cover letter as cited above. 1. List of applicable FCC rules. KDB 996369 D03, Section 2.2 a. Only list rules related to the transmitter. 2. Summarize the specific operational use conditions. KDB 996369 D03, Section 2.3 a. Conditions such as limits on antennas, cable loss, reduction of power for point to point 3. Limited Module Procedures. KDB 996369 D03, Section 2.4 systems, professional installation info a. Describe alternative means that the grantee uses to verify the host meets the necessary limiting conditions b. When RF exposure evaluation is necessary, state how control will be maintained such that compliance is ensured, such as Class II for new hosts, etc. 4. Trace antenna designs. KDB 996369 D03, Section 2.5 a. Layout of trace design, parts list, antenna, connectors, isolation requirements, tests for design verification, and production test procedures for ensuring compliance. If confidential, the method used to keep confidential must be identified and information provided in the operational description. 5. RF exposure considerations. KDB 996369 D03, Section 2.6 a. Clearly and explicitly state conditions that allow host manufacturers to use the module. Two types of instructions are necessary: first to the host manufacturer to define conditions (mobile, portable xx cm from body) and second additional text needed to be provided to the end user in the host product manuals. 6. Antennas. KDB 996369 D03, Section 2.7 a. List of antennas included in the application and all applicable professional installer instructions when applicable. The antenna list shall also identify the antenna types

(monopole, PIFA, dipole, etc note that omni-directional is not considered a type) 7. Label and compliance information. KDB 996369 D03, Section 2.8 a. Advice to host integrators that they need to provide a physical or e-label stating Contains FCC ID: with their finished product a. 8. Information on test modes and additional testing requirements. KDB 996369 D03, Section 2.9 Test modes that should be taken into consideration by host integrators including clarifications necessary for stand-alone and simultaneous configurations. Provide information on how to configure test modes for evaluation 9. Additional testing, Part 15 Subpart B disclaimer. KDB 996369 D03, Section 2.10 b. Sincerely,

- All Items shown to the left are provided in the Modular Integration Guide (or UM) for Full Modular Approval

(MA) or LMA.

- An LMA applies and is approved ONLY for use by the grantee in their own products, and not intended for sale to 3rd parties as provided in a separate cover letter. Therefore the information shown to the left is found in the theory of operation. By:

/Vice President__ _Jay Moulton, RF Exposure Lab____

(Signature/Title1)

(Print name) 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

LANTRONIX Federal Communications Commission 7435 Oakland Mills Road Columbia, Maryland 21046 USA Date: 12/18/2020 Ref: FCC Class Il Permissive change for FCC ID: 2AFDI-ITCOQ626S

(Original Grant date: 05/20/2019) Dear Examiner, This is to request a Class II permissive change for FCC ID: 2AFDI-ITCOQ626S, originally granted on 05/20/2019. The major change filed under this application is:

Change #1: This change is to request approval for portable category specific host Moleculight handheld device: Model: MolecuLightDX and SBI handheld device: Model: Handheld Fluorescence Camera. Sincerely,

pea By: Fathi Hakam Title: VP of Engineering On behalf of: Lantronix Telephone: 949-453-3990 Fax: 949-453-3995 e-mail: fhakam@lantronix.com LANTRONIX 7535 Irvine Center Drive, Suite 100 Irvine, CA 92618 USA Telephone: +1 (949) 453-3990 Fax No: +1 (949) 453-3995 Lantronix.com

SPECIFICATION Part No. Product Name

:

:

AP.17F.07.0064A 17mm Two Stage GPS/GALILEO Active Patch Antenna Module Features

:

22.2mm*23.8mm*7.8mm 64mm 1.13 IPEX MHFI Wide Voltage Input 1.8V to 5.5V 28dB LNA Tested in Free space RoHS Compliant SPE-11-8-145/D/SS Page 1 of 10 1. Introduction The AP.17F is a two stage 17mm active patch antenna that has been designed specifically for embedded (inside device) integration with GPS/GALILEO receiver modules. The AP.17F combines a 17*17*4mm advanced low profile ceramic patch antenna with a one stage LNA and a front-end SAW filter with ultra thin coaxial cable. It comes with its own integrated ground-plane. The front end SAW filter reduces the risks where there is a cellular transmitter nearby of interference from out of band frequencies which can cause LNA burn-out, saturation, or radiated spurious emissions. The antenna can work on a wide input voltage from 1.8V to 5.5V with best in class power consumption figures. If further tuning and optimization specific to a customer device is required Taoglas offers a custom tuned and optimized part service. Contact sales@taoglas.com for more information. Cables and connectors can be customized according to request. SPE-11-8-145/D/SS Page 2 of 10 ANTENNASAW FilterLNAI-PEX +cable 2. Specifications ELECTRICAL Input Voltage Min:1.8V Typ.: 3.0V Max: 5.5V Frequency Range 1575.42MHz +/- 1.023 MHz Gain Polarization Axial ratio

-1.5dBic Typ. @zenith RHCP Max 3.0dB@zenith Frequency Range 1575.42MHz +/- 1.023 MHz Gain (With LNA) At 3.0V 29.5 3dBic At 90 At 5.5V 22.5 3dBic At 1.8V 32.5 3dBic Output Impedance 50 LNA Frequency 1575.42 1.023MHz Outer Band Attenuation Output Impedance Output VSWR Pout at 1dB Gain Compression point F0=1575.42MHz F030MHz 6dB min. F050MHz 20dB min. F0100MHz 25dB min. 50 2.0 Max Typ. -5dBm Min. -9dBm LNA Gain, Power Consumption and Noise Figure Voltage Min. 1.8V Typ. 3.0V Max. 5.5V LNA Gain Power Consumption Noise Figure

(Typ) 21dB 28dB 31dB

(mA) Typ 3.3mA 7.5mA 15.5mA Typ 2.7dB 2.5dB 2.7dB SPE-11-8-145/D/SS Page 3 of 10 MECHANICAL RF Cable 1.13 RF Coaxial Cable L=64mm1.5mm RF Connector Dimensions I-PEX(MHF) - U.FL Comp. 22.2mm*23.8mm*7.8mm ENVIRONMENTAL Operation Temperature

-40C to + 85C Storage Temperature

-40C to + 85C Relative Humidity 40% to 95%

SPE-11-8-145/D/SS Page 4 of 10 2.1. LNA Gain and Out Band Rejection @3.0V 2.2. LNA Noise Figure @3.0V SPE-11-8-145/D/SS Page 5 of 10 3. Radiation Patterns XY Plane XZ Plane YZ Plane SPE-11-8-145/D/SS Page 6 of 10 4. Plugs Usage Precautions 4.1. Mating / Unmating

(1) To disconnect connectors, insert the end portion of I-PEX under the connector flanges and pull off vertically, in the direction of the connector mating axis.

(2) To mate the connectors, the mating axes of both connectors must be aligned and the connectors can be mated. The "click" will confirm fully mated connection. Do not attempt to insert on an extreme angle.

+Z

+X 4.2. Pull forces on the cable after connectors are mated After the connectors are mated, do not apply a load to the cable in excess of the values indicated in the diagram below. SPE-11-8-145/D/SS Page 7 of 10 5. Mechanical Drawing (Unit: mm) SPE-11-8-145/D/SS Page 8 of 10 6. Packaging SPE-11-8-145/D/SS Page 9 of 10 Taoglas makes no warranties based on the accuracy or completeness of the contents of this document and reserves the right to make changes to specifications and product descriptions at any time without notice. Taoglas reserves all rights to this document and the information contained herein. Reproduction, use or disclosure to third parties without express permission is strictly prohibited. Copyright Taoglas Ltd. SPE-11-8-145/D/SS Page 10 of 10