U72DRXPSLV2X-RAY IMAGING FOR HEATHCARE

User Guide for the CARESTREAM DRX Plus and DRX Core/TRIMAX Detectors Publication No. AD7006 2021-06-10 Supersedes: 2021-03-10 All rights reserved. No part of this manual may be reproduced or copied in any form by any means—graphic, electronic, or mechanical, including photocopying, typing, or information retrieval systems—without written permission. Notices and Conventions The information herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, even if loss or damage is caused by Carestream Health’s negligence or fault. Note: Notes provide additional information, such as expanded explanations, hints, or reminders. Important: Important highlights critical policy information that affects how you use this manual and this product. CAUTION: Caution points out a potentially hazardous situation which, if not avoided, might cause minor or moderate injury. Authorized European Representative Carestream Health France SAS 207, Rue de Bercy 75012 Paris France CAUTION: Federal law restricts this device to sale by or on the order of a physician. CAUTION: If you witness or become aware of a potential safety issue with this equipment, take the appropriate safety measures and report this to your Carestream Service representative immediately. AD7006 | 2021-06-10 -iii Notices and Conventions -iv AD7006 | 2021-06-10 Contents Notices and Conventions 1 Safety and Regulatory Information Medical Equipment Classification.................................................................................................. 1-1 Product Safety Standards............................................................................................................... 1-3 EMC Standards................................................................................................................................ 1-3 Precautions...................................................................................................................................... 1-4 FCC Notice (United States)............................................................................................................. 1-6 ISED Notice (Canada)...................................................................................................................... 1-6 Guidance and Manufacturer’s Declaration for Electromagnetic Emissions................................ 1-7 Electromagnetic Immunity............................................................................................................. 1-8 Guidance and Manufacturer’s Declaration for Radio Frequency Immunity..............................1-10 Wireless Declaration..................................................................................................................... 1-11 2 Detector Operation Cautions...........................................................................................................................................2-2 Pediatric Considerations................................................................................................................. 2-3 Change Battery............................................................................................................................... 2-4 Insert the Battery Into the Detector.............................................................................................. 2-4 Battery Unlatch Procedure............................................................................................................. 2-5 Position the Detector in a Bucky....................................................................................................2-6 Using Detectors............................................................................................................................... 2-8 Connect a Tether to the Detector.................................................................................................. 2-9 LED Display Matrix........................................................................................................................ 2-10 Reset Button..................................................................................................................................2-13 3 Detector Overview Transport and Storage Environment............................................................................................. 3-1 Operating Environment................................................................................................................. 3-1 Equipment Maintenance................................................................................................................ 3-2 Procedure to Clean the Detector................................................................................................... 3-3 Procedure to Clean the Battery Well............................................................................................. 3-3 Patient Contact............................................................................................................................... 3-4 Weight Label................................................................................................................................... 3-5 Back-up Battery Information......................................................................................................... 3-6 Disposal......................................................................................................................................3-6 Power Failures................................................................................................................................. 3-7 Publication Hi…

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Manuel d’utilisation des détecteurs CARESTREAM DRX Plus et DRX Core/TRIMAX Publication n° AD7006 2021-06-10 Remplace 2021-03-10 Tous droits réservés. Aucune partie de ce manuel ne peut être reproduite ou copiée sous quelque forme que ce soit—graphique, électronique ou mécanique, y compris la photocopie, la dactylographie ou les systèmes de recherche d'informations—sans autorisation préalable écrite. Notes et conventions Les informations contenues dans le présent document sont fondées sur l’expérience et les connaissances de Carestream Health, Inc. sur le sujet au moment de sa publication. Aucune licence de brevet n’est accordée par les présentes informations. Carestream Health se réserve le droit de modifier ces informations sans préavis et n’offre aucune garantie, expresse ou implicite, les concernant. Carestream Health ne saurait être tenu responsable des pertes ou dommages, y compris de dommages indirects ou secondaires, même s’ils ont été causés par une négligence ou par une faute de Carestream Health. Remarque : Les remarques fournissent des informations complémentaires, telles que des explications détaillées, des conseils ou des rappels. Important : La mention Important fait référence aux informations cruciales relatives aux règles d’utilisation du manuel et du produit. ATTENTION : Caution (Mise en garde) signale une situation potentiellement dangereuse qui, si elle n’est pas évitée, pourrait entraîner des blessures mineures ou modérées. Représentant agréé en Europe Carestream Health France SAS 207, Rue de Bercy 75012 Paris France ATTENTION : En application des lois fédérales américaines, cet appareil ne doit être vendu que par des médecins ou sur prescription d’un médecin. AD7006 | 2021-06-10 -iii ATTENTION : Si vous êtes témoin ou avez connaissance d’un éventuel problème de sécurité avec cet appareil, prenez les mesures de sécurité appropriées et informez-en immédiatement votre prestataire de services Carestream. Notes et conventions -iv AD7006 | 2021-06-10 Sommaire Notes et conventions 1 Informations relatives à la sécurité et aux réglementations Classification de l’équipement médical......................................................................................... 1-1 Normes de sécurité du produit...................................................................................................... 1-3 Normes de compatibilité électromagnétique............................................................................... 1-3 Précautions...................................................................................................................................... 1-4 Avis FCC (États-Unis)....................................................................................................................... 1-6 Avis ISED (Canada).......................................................................................................................... 1-6 Règles et déclaration du fabricant sur les émissions électromagnétiques.................................. 1-7 Immunité aux émissions électromagnétiques............................................................................... 1-8 Règles et déclaration du fabricant sur l’immunité aux fréquences radio................................. 1-10 Déclaration relative aux connexions sans fil............................................................................... 1-11 2 Fonctionnement du détecteur Mises en garde................................................................................................................................ 2-2 Considérations pédiatriques.......................................................................................................... 2-3 Changement de batterie................................................................................................................ 2-4 Insertion de la batterie dans le détecteur..................................................................................... 2-4 Procédure de déverrouillage de la batterie.................................................................................. 2-5 Positionnement du détecteur dans le Potter-Bucky..................................................................... 2-6 Utilisation des détecteurs............................................................................................................... 2-8 Connectez un câble d’attache au détecteur................................................................................. 2-9 Matrice d’affichage à voyants......................................................................................................2-10 Bouton Réinitialiser...................................................................................................................... 2-13 3 Présentation du détecteur Environnement de transport et de stockage................................................................................ 3-1 Environnement d’utilisation.......................................................................................................... 3-1 Maintenance de l’équipement.......................................................................................................3-2 Procédure de nettoyage du détecteur.......................................................................................... 3-3 Procédure de nettoyage du puits de la batterie...........................................................................3-3 Contact du patient..........................................................................................................................3-4 Étiquette de poids.......................................................................................................................... 3-5 Informations sur la batterie de secours......................................................................................... 3-6 Mise au rebut....................................................................................................…

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Carestream Health lnc. 150 Verona Street Rochester, NY, 14608 RE: Model Differences Letter DATE: 03-June-2021 To \A/hom lt May Concern: Please refer to the table below that summarizes the differences between the detectors. All nine models share the exact same pre-certified module FCC lD: UT2OLYM and antenna configuration. There are no CIass I or Class lll permissive changes required as all models share the same pre-certified module FCC lD: U72OLYM. Dated this 3'd Day of June 2021 ,, p ' 8-Q0$..q Eric Dillenbeck Signature Printed Title : Director Of Productivitv & Excellence Telephane: 585-627-6005 Applicant: Carestream Health lnc DRX Core 3543C 227223301235 cm x 43 cm x2cm Cesium lodide Lead DRX Plus 3543C 227223300235cmx43cmx2cm Cesium lodideLead DRX Plus 3543 DRX Plus 354335cmx43cmx2cmGadolinium oxysulfide (GOS) Tungsten DRX Core 3543 227223301135cmx43cmx2cmGadolinium oxysulfide (GOS) Lead DRX Plus 3543 2272233001 35cmx43cmx2cm Gadolinium oxysulfide (GOS) Lead DRX Core 4343C227223311243cmx43cmx2cmCesium lodide Lead DRX Plus 4343C 2272233102 43cmx43cmx2cmCesium lodideLead DRX Core 4343227223311143cmx43cmx2cmGadolinium oxysulfide (GOS) Lead DRX Plus 43432272233101 43cmx43cmx2cm Gadolinium oxysulfide (GOS) Lead

Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada KlV 1H2 Attn: Director of Certification Authority to Act as Asent FCC On our behall I appoint Jenny Gibbs of Nernko USA, Inc. 2650 FM 407, Suite 255P Bartonville, TX16226, to act as our agent in the preparation of this application for equipment certification. I certifo that submitted documents properly describe the device or system for which equipment certification is sought. I also certifi, that each unit manufactured, imported or marketed, as defined in FCC regulations will have affixed to it a label identical to that submitted for approval with this application. In signing this letter, Applicant certifies that neither the applicant nor any party to the application is not subject to a denial ofFederal benefits, that include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 2l U.S.C. $ 862 because of a conviction for possession or distribution of a controlled substance. See 47 CFR 1.2002(b) for the definition of a "pafty" for these purposes. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Carestream Health Inc. (150 Verona St., Rochester, NY, 14608) Dated this 16 Day of April 20 21 Agency agreement expiration date: 16-April-2022 Eric Dillenbeck Printed Title: Director R&D On behalf of : Corestream Health Inc. Signature Telephone: 585-627-6005 By:

DRX Core 3543/3543C Pics 3543 Core Detector Pics 3543C Core Detector Pics 3543/3543C Core Detector Internal Pics -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- DRX Core 4343/4343C Pics 4343 Core Detector Pics 4343C Core Detector Pics 4343/4343C Core Detector Internal Pics

Front cover PMN location Label location 1. DRX Plus 3543 2. DRX Plus 3543 3. DRX Plus 3543C 4. DRX Plus 4343 5. DRX Plus 4343C 6. DRX Core 3543 7. DRX Core 3543C 8. DRX Core 4343 9. DRX Core 4343C

DRX Core 3543/3543C Pics 3543 Core Detector Pics 3543C Core Detector Pics 3543/3543C Core Detector Internal Pics -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- DRX Core 4343/4343C Pics 4343 Core Detector Pics 4343C Core Detector Pics 4343/4343C Core Detector Internal Pics

© 2021 RF Exposure Lab, LLC This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. 802 N. Twin Oaks Valley Road, Suite 105 • San Marcos, CA 92069 • U.S.A. TEL (760) 471-2100 • FAX (760) 471-2121 http://www.rfexposurelab.com CERTIFICATE OF COMPLIANCE SAR EVALUATION Carestream Health Dates of Test: July 6-8, 2021 150 Verona St. Test Report Number: SAR.20210706 Rochester, NY 14608 Revision A This wireless mobile and/or portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in IEEE 1528-2013 and IEC 62209-1528:2020 (See test report). I attest to the accuracy of the data. All measurements were performed by myself or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. RF Exposure Lab, LLC certifies that no party to this application is subject to a denial of Federal benefits that includes FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Jay M. Moulton Vice President Testing Cert. # 2387.01 FCC ID: U72DRXPSLV2 IC Certificate: 7072A-DRXPSLV2 Model(s): DRX Plus 3543, 2272233001, 2272233002, 2272233011, 2272233012 Test Sample: Engineering Unit Same as Production Serial Number: 536 Equipment Type: Wireless X-ray Panel Classification: Portable Transmitter Next to Head and Body TX Frequency Range: 2412 – 2462 MHz; 5180 – 5320 MHz; 5500 – 5700 MHz; 5745 – 5825 MHz Frequency Tolerance: ± 2.5 ppm Maximum RF Output: 2450 MHz (b) – 21.00 dBm, 2450 MHz (g) – 20.00 dBm, 2450 MHz (n20) – 20.00 dBm, 2450 MHz (n40) – 17.00 dBm, 5250 MHz (a) – 16.00 dBm, 5250 MHz (n20) – 16.00 dBm, 5250 MHz (n40) – 15.00 dBm, 5250 MHz (ac80) – 14.00 dBm, 5800 MHz (a) – 18.00 dBm, 5800 MHz (n20) – 18.00 dBm, 5800 MHz (n40) – 17.00 dBm, 5800 MHz (ac80) – 17.00 dBm Conducted Signal Modulation: DSSS, OFDM Antenna Type: Beamtech Engineering Model AL4670; PCB Trace Antenna Application Type: Certification FCC Rule Parts: Part 2, 15C, 15E KDB Test Methodology: KDB 447498 D01 v06, KDB 248227 v02r02, KDB 616217 D04 v01r02 Industry Canada: RSS-102 Issue 5, Safety Code 6 Maximum SAR Value: 1.19 W/kg Reported for both Head and Body Maximum Simultaneous SAR: 0.01 Separation Ratio for both Head and Body Separation Distance: 0 mm Report Number: SAR.20210706 © 2021 RF Exposure Lab, LLC Page 2 of 84 This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. Table of Contents 1. Introduction ........................................................................................................................ 4 SAR Definition [5] ................................................................................................................... 5 2. SAR Measurement Setup ................................................................................................... 6 Robotic System ...................................................................................................................... 6 System Hardware ................................................................................................................... 6 System Electronics ................................................................................................................. 7 Probe Measurement System .................................................................................................. 7 3. Probe and Dipole Calibration .............................................................................................15 4. Phantom & Simulating Tissue Specifications .....................................................................16 Head & Body Simulating Mixture Characterization ................................................................16 5. ANSI/IEEE C95.1 – 1992 RF Exposure Limits [2] ..............................................................17 Uncontrolled Environment .....................................................................................................17 Controlled Environment .........................................................................................................17 6. Measurement Uncertainty .................................................................................................18 7. System Validation..............................................................................................................19 Tissue Verification .................................................................................................................19 Test System Verification ........................................................................................................19 8. SAR Test Data Summary ..................................................................................................20 Procedures Used To Establish Test Signal ...........................................................................20 Device Test Condition ...........................................................................................................20 SAR Data Summary – 2450 MHz Body 802.11b ...................................................................31 SAR Data Summary – 5250 MHz Body 802.11a ...................................................................32 SAR Data Summary – 5800 MHz Body 802.11a ...................................................................33 SAR Data Summary – Simultaneous Evaluation ...................................................................34 9. Test Equipment List ...........................................................................................................35 10. Conclusion ................................................................…

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© 2021 RF Exposure Lab, LLC This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. 802 N. Twin Oaks Valley Road, Suite 105 • San Marcos, CA 92069 • U.S.A. TEL (760) 471-2100 • FAX (760) 471-2121 http://www.rfexposurelab.com CERTIFICATE OF COMPLIANCE SAR EVALUATION Carestream Health Dates of Test: July 12-13, 2021 150 Verona St. Test Report Number: SAR.20210709 Rochester, NY 14608 Revision A This wireless mobile and/or portable device has been shown to be compliant for localized specific absorption rate (SAR) for uncontrolled environment/general exposure limits specified in ANSI/IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in IEEE 1528-2013 and IEC 62209-1528:2020 (See test report). I attest to the accuracy of the data. All measurements were performed by myself or were made under my supervision and are correct to the best of my knowledge and belief. I assume full responsibility for the completeness of these measurements and vouch for the qualifications of all persons taking them. RF Exposure Lab, LLC certifies that no party to this application is subject to a denial of Federal benefits that includes FCC benefits pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Jay M. Moulton Vice President Testing Cert. # 2387.01 FCC ID: U72DRXPSLV2 IC Certificate: 7072A-DRXPSLV2 Model(s): 2272233101, 2272233102, 2272233111, 2272233112 Test Sample: Engineering Unit Same as Production Serial Number: 657 Equipment Type: Wireless X-ray Panel Classification: Portable Transmitter Next to Head and Body TX Frequency Range: 2412 – 2462 MHz; 5180 – 5320 MHz; 5500 – 5700 MHz; 5745 – 5825 MHz Frequency Tolerance: ± 2.5 ppm Maximum RF Output: 2450 MHz (b) – 21.00 dBm, 2450 MHz (g) – 20.00 dBm, 2450 MHz (n20) – 20.00 dBm, 2450 MHz (n40) – 17.00 dBm, 5250 MHz (a) – 16.00 dBm, 5250 MHz (n20) – 16.00 dBm, 5250 MHz (n40) – 15.00 dBm, 5250 MHz (ac80) – 14.00 dBm, 5800 MHz (a) – 18.00 dBm, 5800 MHz (n20) – 18.00 dBm, 5800 MHz (n40) – 17.00 dBm, 5800 MHz (ac80) – 17.00 dBm Conducted Signal Modulation: DSSS, OFDM Antenna Type: Beamtech Engineering Model AL4670; PCB Trace Antenna Application Type: Certification FCC Rule Parts: Part 2, 15C, 15E KDB Test Methodology: KDB 447498 D01 v06, KDB 248227 v02r02, KDB 616217 D04 v01r02 Industry Canada: RSS-102 Issue 5, Safety Code 6 Maximum SAR Value: 1.25 W/kg Reported for both Head and Body Maximum Simultaneous SAR: 0.01 Separation Ratio for both Head and Body Separation Distance: 0 mm Report Number: SAR.20210709 © 2021 RF Exposure Lab, LLC Page 2 of 86 This report shall not be reproduced except in full without the written approval of RF Exposure Lab, LLC. Table of Contents 1. Introduction ........................................................................................................................ 4 SAR Definition [5] ................................................................................................................... 5 2. SAR Measurement Setup ................................................................................................... 6 Robotic System ...................................................................................................................... 6 System Hardware ................................................................................................................... 6 System Electronics ................................................................................................................. 7 Probe Measurement System .................................................................................................. 7 3. Probe and Dipole Calibration .............................................................................................15 4. Phantom & Simulating Tissue Specifications .....................................................................16 Head & Body Simulating Mixture Characterization ................................................................16 5. ANSI/IEEE C95.1 – 1992 RF Exposure Limits [2] ..............................................................17 Uncontrolled Environment .....................................................................................................17 Controlled Environment .........................................................................................................17 6. Measurement Uncertainty .................................................................................................18 7. System Validation..............................................................................................................19 Tissue Verification .................................................................................................................19 Test System Verification ........................................................................................................19 8. SAR Test Data Summary ..................................................................................................20 Procedures Used To Establish Test Signal ...........................................................................20 Device Test Condition ...........................................................................................................20 SAR Data Summary – 2450 MHz Body 802.11b ...................................................................31 SAR Data Summary – 5250 MHz Body 802.11a ...................................................................32 SAR Data Summary – 5800 MHz Body 802.11a ...................................................................33 SAR Data Summary – Simultaneous Evaluation ...................................................................34 9. Test Equipment List ...........................................................................................................35 10. Conclusion .............................................................................…

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www.nemko.com Nemko Canada Inc., a testing laboratory, is accredited by the Standards Council of Canada. The tests included in this report are within the scope of this accreditation. The SCC Accreditation Symbol is an official symbol of the Standards Council of Canada, used under licence. SCC File Number: 15064 (Ottawa/Almonte); 151100 (Montreal); 151097 (Cambridge) FCC 15.247, RSS-247 Issue 2; Date: March, 2020 Choose Scandinavian trust RADIO TEST REPORT – 431080-1R3TRFWL Type of assessment: Final product testing Applicant: Product name (type): Carestream Health, Inc. DRX Core 3543C Model: Model Variants: 2272233012 DRX Plus 3543, 2272233001, 2272233002, 2272233101, 2272233102, 2272233011, 2272233111, 2272233112 FCC ID: IC ID: U72DRXPSLV2 7027A-DRXPSLV2 Specifications:  FCC 47 CFR Part 15 Subpart C, §15.247  RSS-247, Issue 2, Feb 2017, Section 5 Date of issue: June 8, 2021 Mark Libbrecht, EMC/RF Specialist Tested by Signature Andrey Adelberg, Senior EMC/RF Specialist Reviewed by Signature Report reference ID: 431080-1R3TRFWL Page 2 of 46 Lab locations Company name Nemko Canada Inc. Facilities Ottawa site: 303 River Road Ottawa, Ontario Canada K1V 1H2 Tel: +1 613 737 9680 Fax: +1 613 737 9691 Montréal site: 292 Labrosse Avenue Pointe-Claire, Québec Canada H9R 5L8 Tel: +1 514 694 2684 Fax: +1 514 694 3528 Cambridge site: 1-130 Saltsman Drive Cambridge, Ontario Canada N3E 0B2 Tel: +1 519 650 4811 Almonte site: 1500 Peter Robinson Road West Carleton, Ontario Canada K0A 1L0 Tel: +1 613 256-9117 Fax: +1 613 256-8848 Test site registration Organization Recognition numbers and location FCC/ISED FCC: CA2040; IC: 2040A-4 (Ottawa/Almonte); FCC: CA2041; IC: 2040G-5 (Montreal); CA0101 (Cambridge) Website…

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