2AFFF-UVL1500Intravenous Light Therapy Device

©2015 UVLrx Therapeutics Inc. All Rights Reserved. Reproduction or modification is strictly prohibited. 64‐0006 REV B Model UVL1500 USER MANUAL Page 1 of 55 UVLrx Station™ Model UVL1500 User Manual Model UVL1500: Manufactured in the U.S.A., for Export Only. Caution: Federal law restricts this device to sale by or on the order of a physician or properly licensed healthcare provider. Manufacturer: UVLrx Therapeutics Inc. 640 Brooker Creek Blvd., Suite 455, Oldsmar, FL 34677 ©2015 UVLrx Therapeutics Inc. All Rights Reserved. Reproduction or modification is strictly prohibited. 64‐0006 REV B Model UVL1500 USER MANUAL Page 2 of 55 TABLE OF CONTENTS 1. INTRODUCTION.............................................................................................................................. 4 1.1. INDICATION FOR USE ....................................................................................................................... 4 1.2. CONTRAINDICATIONS ...................................................................................................................... 4 1.3. ACKNOWLEDGEMENTS AND ACCREDITATIONS ...................................................................................... 5 2. WARNINGS AND CAUTIONS ........................................................................................................... 6 2.1. RESTRICTIONS ON USE ..................................................................................................................... 6 2.2. WARNINGS ................................................................................................................................... 6 2.3. CAUTIONS ..................................................................................................................................... 7 3. SYSTEM COMPONENTS .................................................................................................................. 9 3.1. UVLRX STATION™ DESCRIPTION ..................................................................................................... 10 3.1.1. UVLrx Station™ – Cleaning Instruction ................................................................... 12 3.2. PATIENT CABLE DESCRIPTION .......................................................................................................... 13 3.2.1. Patient Cable – Cleaning Instruction ....................................................................... 15 3.3. DRY LIGHT ADAPTER™ (DLA) ......................................................................................................... 16 3.3.1. Dry Light Adapter™ – Cleaning Instruction ............................................................. 17 4. LABELS & SYMBOLS ...................................................................................................................... 18 4.1. SYMBOLS .................................................................................................................................... 18 4.2. DEVICE LABEL .............................................................................................................................. 20 4.3. FRONT BEZEL LABEL ...................................................................................................................... 20 4.4. UVLRX SECURITY™ ....................................................................................................................... 21 4.5. SHIPPING CASE LABEL .................................................................................................................... 22 4.6. RFID TARGET LABEL ..................................................................................................................... 22 5. UNPACKING & INSTALLATION ...................................................................................................... 23 5.1. UNPACK THE UVLRX STATION™ ...................................................................................................... 23 5.1. SURFACE MOUNT OR IV POLE MOUNTING? ...................................................................................... 24 5.1.1. IV Pole Mounting Configuration ............................................................................. 24 5.2. CONNECT POWER TO THE UVLRX STATION™ ..................................................................................... 26 5.3. POWER ON THE UVLRX STATION™ ................................................................................................. 27 5.4. CONNECT THE PATIENT CABLE ......................................................................................................... 28 5.5. HOLSTER THE PATIENT CABLE ......................................................................................................... 29 6. CONNECTION OF DRY LIGHT ADAPTER™ ....................................................................................... 30 6.1. CONNECTION OF DRY LIGHT ADAPTER™ TO CATHETER ........................................................................ 30 6.2. CONNECTION OF DRY LIGHT ADAPTER™ TO PATIENT CABLE .................................................................. 31 7. OPERATING INSTRUCTIONS AND USER INTERFACE ....................................................................... 32 7.1. BEGINNING A TREATMENT: CALIBRATION .......................................................................................... 32 7.1.1. Home Screen ........................................................................................................... 32 ©2015 UVLrx Therapeutics Inc. All Rights Reserved. Reproduction or modification is strictly prohibited. 64‐0006 REV B Model UVL1500 USER MANUAL Page 3 of 55 7.1.2. Main Screen ............................................................................................................ 33 7.1.3. Patient Cable – UVLrx Security™ Scanning Screen .................................................. 34 7.1.4. Dry Light Adapter – UVLrx Security™ Scanning Screen ...…

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SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/cts Member of the SGS Group (SGS SA) Attn: Director of Certification Confidentiality Request regarding application for certification of FCC ID: 2AFFF-UVL1500 / IC ID: 20424-UVL1500. Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name Block Diagram Theory of Operation Schematics (UVL1500) Block Diagram (UVL1500) Operational Description (UVL1500) Schematics The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Name: Jeremy Pickens Title: Senior Engineer / Agent for UVLrx Therapeutics Inc. Date: 03 August 2015

UVLrx Therapeutics Inc. 640 Brooker Creek Blvd. Suite 455,Oldsmar, FL 34677 SN REF 2015-1500-001 UVL1500 0 0 8 6 ECREP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany 100 - 240 V 50 / 60 Hz Max Power: 48 VA Replace fuse as marked 2X T 2AL 250V 65-0011 REV D 09/15 i Made in USA for Export Only FCC ID: 2AFFF-UVL1500 IC ID: 20424-UVL1500 710305 ANSI/AAMI ES60601-1 CAN/CSA C22.2 No. 60601-1 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. www.uvlrx.com

Test Report Number: 3715813EMC02 Rev: 2 UVLrx Therapeutics Inc. / UVL1500 Page: 1 of 17 Remarks: This report details the results of the testing carried out on one sample, the results contained in this test report do not relate to other samples of the same product. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. This report may only be reproduced and distributed in full. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. Any mention of SGS International Electrical Approvals or Testing done by SGS International Electrical Approvals in connection with distribution or use of the product described in this report must be approved by SGS international Electrical Approvals in writing. EMC Test Report Project Number: 3715813 Report Number: 3715813EMC02 Revision Level: 2 Client: UVLrx Therapeutics Inc. Product Description: Intravenous Light Therapy System Product Name: UVLrx Station with RFID Model Number: UVL1500 Applicable Standards: FCC Part 15 Subpart C, § 15.209 RSS-210, Issue 8, December 2010 ANSI C63.10: 2013 RSS-GEN, Issue 4, November 2014 AS/NZS 4268:2012 Report issued on: 07 October 2015 Test Result: Compliant Tested by: Jeremy O. Pickens, Senior EMC Engineer Reviewed by: David Schramm, EMC/RF/SAR/HAC Manager Test Report Number: 3715813EMC02 Rev: 2 UVLrx Therapeutics Inc. / UVL1500 Page: 2 of 17 SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/cts Member of the SGS Group (SGS SA TABLE OF CONTENTS 1 SUMMARY OF TEST RESULTS ..................................................................................................................................... 3 1.1 MODIFICATIONS REQUIRED TO COMPLIANCE ................................................................................................................ 3 2 GENERAL INFORMATION ............................................................................................................................................. 4 2.1 CLIENT INFORMATION ................................................................................................................................................... 4 2.2 TEST LABORATORY ....................................................................................................................................................... 4 2.3 GENERAL INFORMATION OF EUT .................................................................................................................................. 4 2.4 OPERATING MODES AND CONDITIONS .......................................................................................................................... 4 2.5 EUT CONNECTION BLOCK DIAGRAM ............................................................................................................................ 5 2.6 SYSTEM CONFIGURATIONS ............................................................................................................................................ 5 2.7 CABLE LIST ................................................................................................................................................................... 5 3 RADIATED EMISSIONS ................................................................................................................................................... 6 3.1 TEST RESULT ................................................................................................................................................................. 6 3.2 TEST METHOD ............................................................................................................................................................... 6 3.3 TEST SITE ...................................................................................................................................................................... 7 3.4 TEST EQUIPMENT .......................................................................................................................................................... 7 3.5 TEST DATA .................................................................................................................................................................... 8 4 CONDUCTED EMISSIONS ............................................................................................................................................ 11 4.1 TEST RESULT ............................................................................................................................................................... 11 4.2 TEST METHOD ............................................................................................................................................................. 11 4.3 TEST SITE .................................................................................................................................................................... 11 4.4 TEST EQUIPMENT ........................................................................................................................................................ 11 4.5 TEST DATA .................................................................................................................................................................. 12 5 OCCUPIED BANDWIDTH ............................................................................................................................................. 14 5.1 TEST RESULT ............................................................................................................................................................... 14 5.2 TEST METHOD .......................................................................................................................…

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