LF59538Patient Assistant

RADIO REGULATORY COMPLIANCE INFORMATION FCC Compliance Information: The following provision applies to the low frequency communications system in the device: 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. The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. *M941673A001* © Medtronic, Inc. 2010 M941673A001A 2010-08-05 World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-514-4000 Fax +1-763-514-4879 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: 1-800-505-4636 Tachycardia: 1-800-723-4636 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.com Tel. +41-21-802-7000 Fax +41-21-802-7900 Medtronic E.C. Authorized Representative/Distributed by Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Technical manuals: www.medtronic.com/manuals

REVEAL ® Patient Assistant 9538/9539 Clinician Manual Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. The following are trademarks of Medtronic: Medtronic and Reveal Explanation of symbols: Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD DIrective 90/385/EEC (NB 0123) and R&TTE 1999/5/EC. Package contents Patient Assistant model 9538 Patient Assistant model 9539 Product documentation For U.S. audiences only Temperature limitation Authorized representative in the European Community Manufacturer Consult instructions for use Date of manufacture Serial number Reorder number Medical equipment with respect to electric shock, fire, and mechanical hazards, only in accordance with UL2601-1, and CAN/CSA C22.2 no. 601.1 Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. Battery polarity as shown Type BF equipment ECREP Battery condition Position of Cell RF transmitter Humidity Limitation Contents Explanation of symbols:2 1 Description and intended use7 1.1 Reveal Patient Assistant model 95388 1.2 Reveal XT Patient Assistant model 95398 2 Package contents and inspection9 2.1 Contents of the Patient Assistant package9 2.2 Inspection9 3 Preparing the Patient Assistant for patient use10 4 Recording cardiac rhythm data10 4.1 How to record cardiac rhythm data10 4.2 Response when a recording is requested12 5 Checking for cardiac rhythm events13 5.1 How to check for cardiac rhythm data storage13 5.2 Response when a query is requested14 6 Troubleshooting15 7 Battery information16 7.1 Replacement batteries16 7.2 When to install batteries16 7.3 How to install new batteries16 8 Attaching the optional wrist strap18 9 Maintenance18 9.1 Care and handling18 9.2 Cleaning19 9.3 Service19 9.4 Disposal19 10 Specifications20 10.1 Device specifications20 10.2 Safety and compatibility standards20 9538/9539 Clinician manual Reveal Patient Assistant 7 1 Description and intended use The Reveal Patient Assistant model 9538 and the Reveal XT Patient Assistant model 9539 are handheld, battery-operated, radio-frequency devices used to communicate with the Reveal Insertable Cardiac Monitor. See the Reveal Clinician Manual provided with the Insertable Cardiac Monitor for specific compatibility information. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor: ■ To verify whether the implanted device has detected a suspected arrhythmia or device related event. ■ To initiate recording of cardiac event data in the implanted device memory. The Patient Assistant is not intended to detect or indicate the presence or absence of medical conditions. Instruct the patient to seek immediate medical attention if he or she is feeling ill, regardless of indications from the Patient Assistant. As directed by the clinician, the patient uses the Patient Assistant during or immediately after a symptomatic event. By pressing a button on the Patient Assistant and holding it in front of his or her implanted device, patients may record the event into the memory of the implanted device. At follow-up visits the implanted device recording is used to check the patient’s cardiac rhythm and help determine if the patient’s symptoms are cardiac related. The patient should be advised to carry or keep their Patient Assistant nearby at all times to avoid the possibility of missing an opportunity to mark a symptomatic episode. Caution: Do not take the Patient Assistant (handheld activator) into the MRI controlled room (magnet room). Doing so can damage the Patient Assistant or the MR scanner. The physician should instruct the patient when to use the Record Symptoms button (both models) and Query button (model 9539) and what to do when a response indicator is received. The Reveal Patient Manual provides a place to record such instructions. See “Preparing the Patient Assistant for patient use” on page 10. 9538/9539 Clinician manual Reveal Patient Assistant 8 1.1 Reveal Patient Assistant model 9538 The Reveal Patient Assistant model 9538, shown in Figure 1, is identified by its single user-operated button located at the upper-right corner of the display area. The Patient Assistant provides the patient with the ability to activate storage of cardiac data when a symptomatic event occurs or has occurred by pressing the Record Symptoms button []. See “Recording cardiac rhythm data” on page 10. When the Record Symptoms button is pressed, the Patient Assistant also indicates if its battery voltage is low and if telemetry with the implanted device was successful. Figure 1.Reveal Patient Assistant model 9538 with all response indicators displayed for reference. 1.2 Reveal XT Patient Assistant model 9539 The Reveal XT Patient Assistant model 9539, shown in Figure 2, is identified by its 2 user-operated buttons, located at the upper-left and upper-right corners of the display area. In addition to the features of the Reveal Patient Assistant model 9538, the Reveal XT Patient Assistant model 9539 has a Query button []. The patient presses the Query button to check if the implanted device has detected important status information such as; low battery, if maximum auto-detected episodes have been reached, or if programmed criteria have been met for cardiac event data. Refer to the Reveal XT 9529 Clinician Manual for information on how to select and enable notification criteria. Record Symptoms button. Press to record cardiac event data. Te l e m e t r y S t a t u s light Wrist strap connector Response indicator display area. One or both indicators light after the button is pressed. 9538/9539 Clinician manual Reveal Patient Assistant 9 Figure 2.Reveal XT Patient Assis…

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February 17, 2014 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Regarding: Application for certification for FCC id: LF59538 Gentlemen: Please find enclosed application for Part 15c certification of a Patient Assistant model 9538, FCC ID:LF59538. The Patient Assistant’s purpose is used for commanding and querying of an implanted device. The implanted devices are approved separately. If you have any questions, please feel call me at 650-585-7077 or contact via email at janet.g.gavidia@ medtronic.com. Sincerely, Janet Gavidia Principal Radio/Telecom Regulatory Affairs Medtronic, Inc. Email:janet.g.gavidia@ medtronic.co m Office:763-536-2373 Calif: 650-585-7077

March 7, 2014 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Request For Permanent Confidentiality FCC ID No.:LF59538 Ladies and Gentlemen: Medtronic, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Commission’s Rules 47 C.F.R. § 0.459 and 0.457, following grant of the application. In support of this request, Medtronic submits the following: (1) identification of the specific information for which confidential treatment is sought: Schematics Block Diagram Theory of Operation / Operational description The materials set forth in these exhibits, which are segregated from the non- confidential exhibits of the application, are those for which confidentiality is sought. (2) identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: The proceeding is that involving the certification of FCC ID No.: LF59538 (3) explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: This information is embodied in circuit diagrams, detailed explanations, parts lists, a block diagram and internal photographs of a device designed for patients under the care of a medical professional. As such, this material is treated as highly confidential business information and information that could convey trade secrets pertaining to manufacturing and design techniques. (4) explanation of the degree to which the information concerns a service that is subject to competition: The information for which confidentiality is sought is employed in the design and manufacture of medical device systems that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. (5) explanation of how disclosure of the information could result in substantial competitive harm: Equipment Authorization Branch Page 2 Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. (6) identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. (7) identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought.. (8) justification of the period during which the submitting party asserts that material should not be available for public disclosure: This material should not be disclosed for at least five years. While improvements in design are likely to be made during this period, disclosure of the design information would lead to insights into both designs and manufacturing techniques and could have an adverse competitive effect for many years to come. This application contains information that will be used in future applications for similar devices. Moreover, the communications aspects of this device are employed in the transmission of highly private medical information to the device. As such, it is important that information pertaining to the design and operation of this device not be made available to unauthorized persons who might attempt to use knowledge of the design to compromise the applications for which the equipment will be employed. Respectfully, Janet Gavidia Prin. Radio/ Telecom Regulatory Affairs Specialists Medtronic, Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 Email:[email protected] Ph: (763) 526-2373

February 17, 2014 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Non-Routine Confidentiality Request FCC ID No.:LF59538 Ladies and Gentlemen: We understand Internal Photos are not typically held confidential, but may be eligible for confidentiality in certain circumstances. Confidentiality for this information may be granted in the following circumstances -Internal photos of a non-consumer device may be held confidential if the device is not accessible to the general public Medtronic, Inc. (“Medtronic”) requests that the internal photos pertaining to the above-referenced application be withheld from public disclosure in accordance with Section 0.457 and 0.459 of the Commission’s Rules, 47 C.F.R. , following grant of the application. Medtronic’s Patient Assistant which is the subject of this filing is not available for general public to order. It is a prescription device and is paired to work with patient’s specific implantable device. These systems are provided to patients by the physician following their surgery. Information regarding internal photos is not released to the public, the device cannot be obtained by the public and any parties with access to this information are required to sign a non-disclosure agreement. It is with this understanding that we respectfully request the Agency to honor our request to maintain internal photos confidential. Respectfully, Janet Gavidia Prin. Radio/ Telecom Regulatory Affairs Specialists Medtronic, Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 Email:[email protected] Ph: (763) 526-2373

FCC LF5‐9538 External Photos

FCC ID: label with location The permanent label is located on the bottom of the unit, the material makes it difficult to remove. Material: 10 Mil. Polycarbonate with velvet/matt texture. Adhesive: 3M 467MP, 2 Mil or Medtronic approved equivalent. Materials to be UL recognized. Labels to be ROHS compliant. Model No. 9538 REVEAL Patient Assistant FCC ID:LF59538 Trade Name: Medtronic

Medtronic Inc. 9538/9539 Patient Assistant FCC 15:209:2012 Report #: MDTR0304.1 Rev. 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: January 13, 2014 Medtronic, Inc. Model: 9538/9539 Patient Assistant Emissions Test Description Specification Test Method Pass/Fail Field Strength of Fundamental FCC 15.209:2014 ANSI C63.10:2009 Pass Spurious Radiated Emissions FCC 15.209:2014 ANSI C63.10:2009 Pass Deviations From Test Standards None Approved By: Tim O'Shea, Operations Manager NVLAP Lab Code: 200881-0 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 01 Corrected Model Number 2/11/2014 Cover, 2, 7, 8, 11, 12, 14-17 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 2013.06.28 FACILITIES 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 Test (EUT) Information Company Name: Medtronic, Inc. Address: 8200 Coral Sea St. NE City, State, Zip: Mounds View, MN 55112 Test Requested By: Girad Guillaume Model: 9538/9539 Patient Assistant First Date of Test: January 13, 2014 Last Date of Test: January 13, 2014 Receipt Date of Samples: January 13, 2014 Equipment Design Stage: Prototype Equipment Condition: No Damage Information Provided by the Party Requesting the Test Functional Description of the EUT (Equipment Under Test): Hand-held, battery-operated telemet…

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photo FF 001.jpg FF 002.jpg FIELD STRENGTH OF FUNDAMENTAL PSA-ESCI 2012.12.14 photo FF 003.jpg FF 004.jpg FIELD STRENGTH OF FUNDAMENTAL PSA-ESCI 2012.12.14 photo FF 001.jpg FF 002.jpg SPURIOUS RADIATED EMISSIONS PSA-ESCI 2012.12.14 photo FF 003.jpg FF 004.jpg SPURIOUS RADIATED EMISSIONS PSA-ESCI 2012.12.14