ESCCRM6299136299

LATITUDE Consult™ System CLINICIAN USER MANUAL CAUTION: Federal (USA) law restricts this device to distribution and use by or on the lawful order of a physician. 359165-001_US ClinicianManual.book Page 1 Thursday, July 18, 2013 8:23 AM 359165-001_US ClinicianManual.book Page 2 Thursday, July 18, 2013 8:23 AM Clinician User Manual - 1 Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 How the System Works . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 System Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 LATITUDE Consult™ Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Powering up the Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Initial Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Reading Data from the Patient’s Implanted Device . . . . . . . . . . . . . . . . . . . 10 Sending (Transmitting) the Patient’s Implanted Device Data . . . . . . . . . . . 11 Reviewing Transmitted Device Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Cleaning the Communicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Returning, Replacing, or Disposing of the Communicator . . . . . . . . . . . . . 14 Software Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 APPENDIX A: Communicator Technical Specifications . . . . . . . . . . . . . . . 15 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 APPENDIX B: Communicator Standards Information . . . . . . . . . . . . . . . . . 17 Safety and Standards Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Electromagnetic Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . 19 APPENDIX C: Symbols on Packaging, Device, and Accessories . . . . . . . 25 359165-001_US ClinicianManual.book Page 1 Thursday, July 18, 2013 8:23 AM 2 - Clinician User Manual 359165-001_US ClinicianManual.book Page 2 Thursday, July 18, 2013 8:23 AM Clinician User Manual - 3 INTRODUCTION The LATITUDE Consult™ system provides clinicians a convenient and secure way to review data from a Boston Scientific implanted device. Intended Use The LATITUDE Consult system is intended to read data from a compatible Boston Scientific implanted device and transfer it to a central server. The LATITUDE Consult system can provide implanted device data that may be used as part of the clinical evaluation of the patient. This literature is intended for use by health care providers of the LATITUDE Consult Communicator System. How the System Works The LATITUDE Consult Communicator is used to read data from a patient's implanted device via a telemetry wand placed over the patient's device. Once the data is read, the clinician uses the Communicator to send the data to the secure LATITUDE Consult server. The clinician then contacts Boston Scientific to request a review of the data and optionally obtain reports. LATITUDE Consult is a trademark of Boston Scientific or its affiliates. 359165-001_US ClinicianManual.book Page 3 Thursday, July 18, 2013 8:23 AM 4 - Clinician User Manual Contraindications The LATITUDE Consult Communicator is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE Consult system. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being read. Warnings The Communicator is MR (Magnetic Resonance) Unsafe. The Communicator is MR Unsafe and must remain outside the MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices 1 . Under no circumstances should the Communicator be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas. Precautions In order to ensure a review by Boston Scientific of the patient’s implanted device data, the clinician must call LATITUDE Consult Technical Services at 1-800-CARDIAC (227-3422) after sending the data. Adverse Effects None known. System Limitations This system is intended for use by health care providers in a health care facility. As appropriate, clinical care needs to be provided to the patient, separate from the use of the Communicator. The LATITUDE Consult system can only read data from an implanted device and cannot reprogram, command lead tests, or change any functions of the implanted device. Therefore, LATITUDE Consult Communicator interrogations are not intended to be used in place of in- office follow ups that involve programming of the implanted device (e.g., changing device settings) or commanding lead tests (e.g., pacing threshold test). The implanted device can only be programmed with a Progra…

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FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation Date: 9/12/2013 Re: Model 6299 Latitude™ Rock Springs Point of Care (Consult) Communicator: FCC Cover Letter The Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management, hereinafter referred to as BSC Model 6299 LATITUDE™ Rock Springs Point of Care (a.k.a., Consult) is an in-clinic or hospital monitor for use with inductive telemetry enabled BSC implantable pulse generators in the Cognis, Teligen, Progeny, Ingenio, Insignia, and Altrua devices included under FCC ID ESCCRMN11906 and ESCCRMV17311. Introduction The Model 6299 is a new product for the Guidant Corporation. This is a new device in a family of Boston Scientific products used to interrogate BSC implantable devices. The Model 6299 is similar to a series of LATITUDE TM home-based products used to monitor patients in the home either via an inductive link or wireless telemetry. This device differs in that it is intended for use by medical professionals in clinics or hospitals. Since this is a new product, this will be an original certification. The FCC ID chosen for this product is based on previously approved similar products and is ESCCRM629913. The FCC rules applicable to the inductive link portion of this product include CFR FCC Part 15.205, Part 15.207, and Part 15.209. Even though the Bluetooth radio is not enabled in this product, the module is approved as FCC ID POOWML-C40. Lastly, since the product also includes an analog modem connection, FCC Part 68 also applies. Device Description The Model 6299 has dedicated transmit and receive coils connected to a discrete transceiver subsystem. The inductive transceiver is controlled by the telemetry hardware logic on the wand board and the microprocessor on the Communicator’s main circuit board. The Model 6299 firmware controls the On-Off-Keyed (OOK) intentional Boston Scientific Corporation emissions transmit power and rate of occurrence per the BSC proprietary telemetry protocol. The system receiver is capable of supporting high speed and legacy inductive pulse generators employing quadrature phase shift keying (QPSK) and OOK modulation. The Model 6299 auto-detects which protocol (i.e., transmit and receive data rates) to use during the initial interchange with the pulse generator being interrogated. A custom BSC software application is run on the device embedded microprocessor that controls all of the device features and functions. The transceiver operation is controlled via this processor. Additional timing controls for the transceiver functions on the wand board are controlled by a Complex Programmable Logic Device (CPLD). The CPLD firmware is loaded during the manufacturing process. Figure 1 shows the Model 6299. The design consists of an Integrated Main Circuit Board (IMCB), Button Board (BB), Wand Control Board (WCB), and wand cable. Internal to the Model 6299 there is also a liquid crystal display (LCD) with touch screen, plastic internal frame and miscellaneous cables. The device is wall-powered using an AC/DC power brick. Figure 1. BSC Model 6299

WTD 13.4.9 FCC Compliance Opinion BSTN0426 Information about the Applicant Grantee (Company Name) Boston Scientific Corporation FCC Contact Person James Kippola Address 4100 Hamline Avenue North M/S 10-203 City, State, Zip St. Paul, MN 55112-5798 Job Number BSTN0426 Model 6299 FCC ID ESCCRM629913 Agent Larry Canady Approval Type Original Equipment Class DCD Part 15, low power Tx below 1.705 MHz Rule Part 15.209 Overview The model 6299 is an in-clinic or hospital monitor for use with inductive telemetry enabled Boston Scientific Corporations implantable pulse generators in the Cognis, Teligen, Progeny, Ingenio, Insignia and Altrua devices. The Model 6299 uses an inductive coil with resonance around 57 kHz. Test reports and exhibits have been submitted to show compliance with FCC 15.209 requirements for certification. Confidentiality requested for allowed files. Request is properly addressed and referenced. Short term confidentiality requested for internal photos. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 9/16/2013

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FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation Date: August 14, 2013 To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 From: Larry Canady, [email protected] Boston Scientific Corporation 4100 Hamline Ave. N. Arden Hills, MN 55112 Subject: Request for Confidentiality – Application for Equipment Certification, FCC: ESCCRM629913 To whom it may concern, We hereby respectfully request that under the provision 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status.  Schematics  Operational Description  Frequency and Functional Block Diagrams Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by the Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management). Substantial competitive harm could result should these documents be made available to the public while also providing unjustified benefits to our competitors. Pursuant to FCC Public Notice DA 04-1705, we respectfully request short-term confidentiality for the internal photos. The internal photos should be held from public view for 180 days, or until we begin marketing of the device, whichever happens first. Boston Scientific Corporation We will notify the FCC or the TCB prior to marketing so that the internal photos may be placed in the public database. Sincerely, Larry Canady Fellow, Electrical Engineer Boston Scientific Corporation

FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation Date: 9/12/2013 Re: Model 6299 Latitude™ Rock Springs Point of Care (Consult) Communicator: External Photos The Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management, hereinafter referred to as BSC Model 6299 LATITUDE™ Rock Springs Point of Care (a.k.a., Consult) is an in- clinic or hospital monitor for use with inductive telemetry enabled BSC implantable pulse generators in the Cognis, Teligen, Progeny, Ingenio, Insignia, and Altrua devices. The following are external photos of the Model 6299. Figure 1. BSC Model 6299 - Front View (for reference only) Boston Scientific Corporation Figure 2. BSC Model 6299 – Left Side View (for reference only) Figure 3. BSC Model 6299 – Right Side View (for reference only) Boston Scientific Corporation Figure 4. BSC Model 6299 – Back View (for reference only) Figure 5. BSC Model 6299 – Bottom View, Label Removed (for reference only) Note: The bottom label is removed on the picture above. Label information is shown in the ID Label and Location Exhibit. Picture provided to show the device bottom features and is for reference only. Boston Scientific Corporation Figure 6. BSC Model 6299 – Wand Top View (for reference only) Figure 7. BSC Model 6299 – Wand Top View (for reference only) Note: The wand bottom label is from a prototype device. Picture provided to show the wand bottom features and is for reference only. Boston Scientific Corporation Figure 8. BSC Model 6299 Power Adapter (for reference only)

FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation Date: 9/12/2013 Re: Model 6299 Latitude™ Rock Springs Point of Care (Consult) Communicator: FCC ID Labels and Locations The Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management, hereinafter referred to as BSC Model 6299 LATITUDE™ Rock Springs Point of Care (a.k.a., Consult) is an in- clinic or hospital monitor for use with inductive telemetry enabled BSC implantable pulse generators in the Cognis, Teligen, Progeny, Ingenio, Insignia, and Altrua devices. The Model 6299 labels are shown in the following figures. Figure 1. BSC Model 6299 – Bottom Label (for reference only) Boston Scientific Corporation Figure 2. BSC Model 6299 – Bottom Label Location (for reference only) Boston Scientific Corporation CONFIDENTIAL Figure 3. BSC Model 6299 – Rear Label and Location (for reference only) DC Power Input Phone Pass-Thru Connection Wall/Phone Connection Boston Scientific Corporation Figure 4. BSC Model 6299 – Wand Bottom Label and Location (for reference only) Note: The wand bottom label is from a prototype device and is provided for reference only.

FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation CONFIDENTIAL Date: 9/12/2013 Re: Model 6299 Latitude™ Rock Springs Point of Care (Consult) Communicator: Internal Photos The Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management, hereinafter referred to as BSC Model 6299 LATITUDE™ Rock Springs Point of Care (a.k.a., Consult) is an in- clinic or hospital monitor for use with inductive telemetry enabled BSC implantable pulse generators in the Cognis, Teligen, Progeny, Ingenio, Insignia, and Altrua devices. The following are internal photos of the Model 6299. Figure 2. Internal Frame Separated from Main Board (for reference only) Main Circuit Board Wand Cable with Strain Relief Wand Cable Interface Connector Boston Scientific Corporation CONFIDENTIAL Figure 2. Main Board – Top Side (for reference only) Figure 3. Main Board – Bottom Side (for reference only) Processor Wand Transceiver Interface Circuitry Wand Cable Connector Boston Scientific Corporation CONFIDENTIAL Figure 4. Wand Printed Circuit Assembly – Top Side (for reference only) Figure 5. Wand Printed Circuit Assembly – Bottom Side (for reference only)

FCC ID: ESCCRMN!!()^ _ Boston Scientific Corporation CONFIDENTIAL Date: 9/12/2013 Re: Model 6299 Latitude™ Rock Springs Point of Care (Consult) Communicator: Antenna (Inductive Coil) Description The Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management) Model 6299 LATITUDE™ Rock Springs Point of Care (a.k.a., Consult) Communicator is intended for use by health care providers in a health care facility. It is intended for use with the BSC Cognis, Teligen, Progeny, Ingenio, Insignia, and Altrua implantable pulse generators. Per TCB413 this file must contain the following information: a) Describe compliance of the device with the antenna requirements of paragraph 15.203 of the FCC rules. Access to the Guidant Corporation (a wholly owned subsidiary of Boston Scientific Corporation doing business as Boston Scientific Cardiac Rhythm Management) Model 6299 transmit coil, coil connector and intentional radiator circuitry is prohibited by the Model 6299 wand enclosure and main housing. b) A list of antennas to be used with the transmitter. Include manufacturer, model number, gain (dBi), and description (e.g. dipole, yagi, patch, etc.). The inductive transmit coil is a proprietary coil that is adjacent to the receive coil, both of which are wound on a plastic bobbin. The coil assembly is plugged in to the wand printed circuit board. The effective radiated power is controlled by how long the transmit coil is charged before opening one of the coil connections, causing the voltage to increase rapidly and then dissipate at the natural resonant frequency of the tuned transmit loop. The maximum radiated output power level was measured as part of the IEC 60601-1-2 compliance testing and found to be 14.5dBuV/m @ 3m or 20.8dB below the FCC 15.209 limit. This is documented in Northwest EMC test report Boston Scientific Corporation CONFIDENTIAL BSTN0426.1. See picture below for more details on the construction of the coil assembly. c) Drawing or photograph unless clear photos appear in the external photos exhibit A photograph of the coil assembly is included in the internal photos exhibit.

Boston Scientific Corporation Rock Springs Point of Care (POC) Communicator Model 6299 FCC 15.205:2013 FCC 15.207:2013 FCC 15.209:2013 Report #: BSTN0426.1 Report Prepared By Northwest EMC Inc. NORTHWEST EMC – (888) 364-2378 – www.nwemc.com California – Minnesota – Oregon – New York – Washington WTD 12.5.23 CERTIFICATE OF TEST Last Date of Test: May 31, 2013 Boston Scientific Corporation Rock Springs Point of Care (POC) Communicator, Model 6299 Emissions Test Description Specification Test Method Pass/Fail Field Strength of Fundamental FCC 15.209:2013 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.209:2013 ANSI C63.10:2009 Pass AC Powerline Conducted Emissions FCC 15.207:2013 ANSI C63.10:2009 Pass Restricted Bands of Operation FCC 15.205:2013 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 Test Facility The measurement facility used to collect the data is located at: Northwest EMC, Inc. 9349 W Broadway Ave. Brooklyn Park, MN 55445 Phone: (763) 425-2281 Fax: (763) 424-3469 This site has been fully described in a report filed with and accepted by the FCC (Federal Communications Commission) and Industry Canada (Site filing #2834E-1). This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government of the United States of America. Product compliance is the responsibility of the client, therefore the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. This Report may only be duplicated in its entirety. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. REV 2012.08.02 REVISION HISTORY Revision Number Description Date Page Number 00 None Barometric Pressure The recorded barometric pressure has been normalized to sea level. REV 2012.05.24 ACCREDITATIONS AND AUTHORIZATIONS United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC Guide 65 as a product certifier. This allows Northwest EMC to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada IC - Recognized by Industry Canada as a Certification Body (CB). Certification chambers and Open Area Test Sites are filed with IC. European Union European Commission – Validated by the European Commission as a Conformity Assessment Body (CAB) under the EMC directive and as a Notified Body under the R&TTE Directive. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea KCC / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Hong Kong OFTA – Recognized by OFTA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. Russia GOST – Accredited by Certinform VNIINMASH, CERTINFO, SAMTES, and Federal CHEC to perform EMC and Hygienic testing for Information Technology products to GOST standards. SCOPE For details on the Scopes of our Accreditations, please visit: http://www.nwemc.com/accreditations/ REV 2013.03.8 MEASUREMENT UNCERTAINTY Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document WP 342. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) for each test is listed below. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-1 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests that may be contained in this report. Test + MU - MU Frequency Accuracy (Hz) 0.12 -0.01 Amplitude Accuracy (dB) 0.49 -0.49 Conducted Power (dB) 0.41 -0.41 Radiated Power via Substitution (dB) 0.69 -0.68 Temperature (degrees C) 0.81 -0.81 Humidity (% RH) 2.89 -2.89 Field Strength (dB) 3.80 -3.80 AC Powerline Conducted Emissions (dB) 2.94 -2.94 REV 2013.02.26 LOCATIONS Oregon Labs EV01-12 22975 NW Evergreen Pkwy Hillsboro, OR 97124 (503) 844-4066 California Labs OC01-13 41 Tesla Irvine, CA 92618 (949) 861-8918 New York Labs NY01-04 4939 Jordan Rd. Elbridge, NY 13060 (315) 685-0796 Minnesota Labs MN01-08 9349 W Broadway Ave. Brooklyn Park, MN 55445 (763) 425-2281 Washington Labs NC01-05,SU02,SU07 19201 120 th Ave. NE Bothell, WA 98011 (425) 984-6600 VCCI A-0108 A-0029 A-0109 A-0110 Industry Canada 2834D-1, 2834D-2 2834B-1, 2834B-2, 2834B-3 2834E-1 2834C-1 NVLAP NVLAP Lab Code: 200630-0 NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200761-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200629-0 WTD 12.5.23 PRODUCT DESCRIPTION Client and Equipment Under…

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photo SE-FF 001.jpg SE-FF 002.jpg Field Strength of Fundamental PSA-ESCI 2012.12.14 photo SE-FF 003.jpg SE-FF 004.jpg Field Strength of Fundamental PSA-ESCI 2012.12.14 photo SE-FF 001.jpg SE-FF 002.jpg Spurious Radiated Emissions PSA-ESCI 2012.12.14 photo SE-FF 003.jpg SE-FF 004.jpg Spurious Radiated Emissions PSA-ESCI 2012.12.14 WTD.2013.05.09, PSA-ESCI 2012.12.14, PSA-ESCI Version 2013.2.20 AC POWERLINE CONDUCTED EMISSIONS