RIA-MRLN3650ACCUSB Dongle with BLE

Merlin™ Patient Care System Merlin™ PCS, Model 3650 Merlin™ Antenna, Model 3638 Merlin™ PSA, Model EX3100 User's Manual Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, LLC and its related companies. ‡ Indicates a third-party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. Pat. http://www.abbott.com/patents © 2020 St. Jude Medical, LLC. All Rights Reserved. i Contents Introduction .............................................................................................................. 1 Indications ................................................................................................................ 1 Intended Use ............................................................................................................ 1 Contraindications ...................................................................................................... 1 Technical Support ..................................................................................................... 1 Features ................................................................................................................... 3 Setup Instructions ..................................................................................................... 7 Merlin™ PCS Setup ............................................................................................................. 7 Shut Down ......................................................................................................................... 10 Merlin™ PSA Model EX3100 Setup .................................................................................... 10 PSA Wand Model 3150 Setup ............................................................................................ 14 RF Communication Setup .................................................................................................. 14 Bluetooth Wireless Communication Setup ........................................................................... 17 Emergency Operation ......................................................................................................... 18 External Device Connection ................................................................................................ 18 Printer Paper ..................................................................................................................... 20 Software Download ............................................................................................................. 20 Maintenance and Troubleshooting ........................................................................... 21 Maintenance ...................................................................................................................... 21 Cleaning ............................................................................................................................ 21 Programmer Self Test/Preventive Maintenance ................................................................... 21 Troubleshooting ................................................................................................................. 22 Technical Data ........................................................................................................ 25 Merlin™ PCS Specifications ............................................................................................... 25 Merlin™ Antenna Specifications ......................................................................................... 26 Essential Performance ........................................................................................................ 26 Data Security ..................................................................................................................... 26 Electromagnetic Compatibility ............................................................................................. 27 Storage and Operating Conditions ....................................................................................... 34 Disposal ............................................................................................................................. 34 Accessories ........................................................................................................................ 34 Symbols .................................................................................................................. 36 1 Introduction The Merlin™ Patient Care System (Merlin™ PCS) Model 3650 User's Manual describes the components, setup, maintenance, accessories, and technical data of the Merlin PCS. For information on St. Jude Medical implantable devices, select the ? button from any device session screen. Indications The Merlin™ PCS Model 3650 programmer is indicated for use for patients with bradyarrhythmias, tachyarrhythmias or heart failure undergoing implantation, lead revision, explant or device follow-up of a cardiac monitor, pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy system. Intended Use The St. Jude Medical Merlin™ PCS Model 3650 is a portable, dedicated system designed to interrogate, program, display data from, and test St. Jude Medical implantable devices during implant and follow up. At time of implant, it is intended to assess the pacing and sensing performance of the lead after it is connected to the pulse generator. The Telemetry Wand Model 3630 is intended to provide inductive communication between the programmer and the pulse generator during a programming session. The Merlin PCS ECG function when using the ECG cable Models 3617, 3626 and EX3001 is intended to display the patient electrocardiogram and used to support activities related …

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TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 September 12, 2019 TUV SUD BABT FCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Attention: Director of Certification RE: Analysis of RF Exposure for Portable and Mobile use per KDB 447498 D01 RF Exposure Procedures and Equipment Authorization Policies for Mobile and Portable Devices v06 and RSS-102 Radio Frequency (RF) Exposure Compliance of Radio Communication Apparatus (All Frequency Bands) Issue 5 (March 19, 2015) FCC ID: RIA-MRLN3650ACC IC: 7067A-MRLN3650ACC Portable exposure SAR Exemption Calculation using a 5mm separation distance: As per Clause 4.3.1 (a) of KDB 447498 D01 v06: ( max.power of channel,including tune−up tolerance,mW min.test separation distance,mm ) x (√ 푓 ( 퐺퐻푧 ) ) ≤ 3.0 ( max.power of channel,including tune−up tolerance,mW 5 mm ) x ( √ 2.402 ( 퐺퐻푧 ) ) ≤ 3.0 Max. power of channel, including tune-up tolerance = 7.75mW The EUT complies with the SAR Test Exclusion Thresholds for worst case channel 2402MHz at 5 mm having an EIRP of 5.5mW (7.4 dBm EIRP) and being less than the max. power of channel allowed, including tune- up tolerance which is 7.75mW. Exemption Limits for Routine Evaluation — SAR Evaluation (RSS-102 Clause 2.5.1) Frequency (MHz) At separation distance of≤5 mm At separation distance of≤10 mm 2402 4.2 mW 7.2 mW With an EIRP of 5.5mw, the EUT complies with the Exemption Limits if the separation distance is 7.5 mm. This is easily achieved as the EUT is a USB dongle and the typical separation distance from the end user is > 7.5 mm. TÜV SÜD AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 FAX: 858 546 0364 Sincerely, Ferdie S. Custodio Name Authorized Signatory Title: Senior EMC Test Engineer / Wireless Team Lead

TÜV SÜD America, Inc. 10040 Mesa Rim Road San Diego, CA 92121-2912 TÜV SÜD America, Inc. Rancho Bernardo Facility 16936 Via Del Campo San Diego, CA 92127 Phone: 858 678 1400 www.tuv-sud-america.com TÜV SÜD RESPONSIB LE FOR NAME DATE SIGNATURE Authorized Signatory Alex Chang February 12, 2020 Signatures in this approval box have checked this document in line with the requirements of TÜV SÜD document control rules. EXECUTIVE SUMMARY A sample of this product was tested and found to be in compliance with FCC Part 15 Subpart C §15.247 and IC RSS-247 Issue 2 February 2017. Radio Testing of the Abbott Laboratories BLE Dongle Model: BLU2000 In accordance with FCC Part 15 Subpart C §15.247 and IC RSS-247 Issue 2 February 2017 Abbott Laboratories 15900 Valley View Court Sylmar, California 91342 USA COMMERCIAL-IN-CONFIDENCE Date: February 2020 Document Number: 72152653A Rev.02 Issue 01 | Version Number: 01 A2LA Cert. No. 2955.13 DISCLAIMER AND COPYRIGHT This non-binding report has been prepared by TÜV SÜD America with all reasonable skill and care. The document is confidential to the potential Client and TÜV SÜD Americae. No part of this document may be reproduced without the prior written approval of TÜV SÜD America. ACCREDITATION Our A2LA Accreditation does not cover opinions and interpretations and any expressed are outside the scope of our A2LA Accreditation. FCC ID: RIA-MRLN3650ACC IC: 7076A-MRLN3650ACC Report No. 72152653A Rev.02 COMMERCIAL-IN-CONFIDENCE Page 2 of 51 REPORT ON TEST REPORT NUMBER TEST REPORT DATE Radio Testing of the Abbott Laboratories Model BLU2000 BLE Dongle 72152653A Rev.02 February 2020 PREPARED FOR Abbott Laboratories 15900 Valley View Court Sylmar, California 91342 USA CONTACT PERSON Perry Li Principal Engineer [email protected] (818) 493-3793 PREPARED BYFerdinand S. Custodio Name Authorized Signatory Title: Senior EMC Test Engineer / Wireless Team Lead APPROVED BYAlex Chang Name Authorized Signatory Title: Senior EMC/RF Wireless Test Engineer DATED February 12, 2020 FCC ID: RIA-MRLN3650ACC IC: 7076A-MRLN3650ACC Report No. 72152653A Rev.02 COMMERCIAL-IN-CONFIDENCE Page 3 of 51 Revision History 72152653A Rev.02 Issue 01 | Version Number: 01 Abbott Laboratories Model BLU2000 BLE Dongle DATE OLD REVISION NEW REVISION REASON PAGES AFFECTED APPROVED BY 09/27/2019 ― Initial Release Alex Chang 10/04/2019 Initial Release Rev.01 Model number correction Cover page, 2, 3, 5, 6, 8, and 13 Alex Chang Section 1.4.5 Data Rate correction 10 02/12/2020 Rev.01 Rev.02 Industry Canada Company ID Code change All Alex Chang FCC ID: RIA-MRLN3650ACC IC: 7076A-MRLN3650ACC Report No. 72152653A Rev.02 COMMERCIAL-IN-CONFIDENCE Page 4 of 51 CONTENTS 1REPORT SUMMARY ................................................................................................................... 5 1.1Introduction ................................................................................................................................... 6 1.2Brief Summary Of Results ............................................................................................................ 7 1.3Product Information ...................................................................................................................... 8 1.4EUT Test Configuration ................................................................................................................ 9 1.5Deviations From The Standard ................................................................................................... 11 1.6Modification Record .................................................................................................................... 11 1.7Test Methodology ....................................................................................................................... 11 1.8Test Facility Location .................................................................................................................. 11 1.9Test Facility Registration ............................................................................................................ 11 2TEST DETAILS .......................................................................................................................... 13 2.1Peak Output Power..................................................................................................................... 14 2.2Conducted Emissions ................................................................................................................. 17 2.399% Emission Bandwidth ........................................................................................................... 18 2.4Minimum 6 dB RF Bandwidth ..................................................................................................... 22 2.5Out-Of-Band Emissions - Conducted ......................................................................................... 26 2.6Band-Edge Compliance Of RF Conducted Emissions ............................................................... 29 2.7Radiated Spurious Emissions ..................................................................................................... 33 2.8Power Spectral Density .............................................................................................................. 39 3TEST EQUIPMENT USED ......................................................................................................... 43 3.1Test Equipment Used ................................................................................................................. 44 3.2Measurement Uncertainty .......................................................................................................... 45 4DIAGRAM OF TEST SETUP ..................................................................................................... 47 4.1Test Setup Diagram .................................................................................................................... 48 5ACC…

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FCC ID: RIA-MRLN3650ACC IC: 7067A- MRLN3650ACC Radiated Emissions Test Setup (30MHz to 1GHz) Radiated Emissions Test Setup (above 1GHz) Antenna Conducted Port Test Setup