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LF5MCS3101COMCS3101CO

Medtronic, Inc.
MCS3101CO - FCC ID LF5MCS3101CO - Medtronic, Inc.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
May 14, 2020
Application Purpose
Original Equipment
Date of Application
May 14, 2020
Equipment Note
MCS3101CO
Frequency Range
2402.00000000 - 2480.00000000
Company
Medtronic, Inc.
Country
United States

Documents & Files

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Users Manual

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Operational Description

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RF Exposure Info

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Test Report

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Test Setup Photos

Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

Medtronic HVAD PA L ™ System Patient Manual Quick Reference Guide for Alarms When an alarm occurs, text displays on the controller screen. The text tells you what the alarm is and what to do. The chart below shows all potential alarms you may see on your controller. Alarm Type: Critical Alarm Signal Controller Message What it means What action to take Flashing RED back light Flashing alert symbol Loud audio signal and vibration Unable to mute alarm [Change Controller] • Controller failure. • Controller component failed. • Pump failure. • Pump unable to start in 5 attempts. • Change the controller immediately. • Contact your clinician. [Connect Pump Cable] • Pump cable (driveline) disconnection. • Pump cable (driveline) fracture. • Connector is malfunctioning or broken. • Pump electrical failure. • Connect the pump cable (driveline) to the controller Coiled Cable. • If not resolved, change the controller. • Contact your clinician. [Plug in Power Cord] • Disconnecting external battery without a power cord connected could risk pump stop. • The internal battery has limited time remaining, is unreliable, disconnected or has failed AND • The external battery has less than 15 minutes runtime remaining or is unreliable. • Connect the power cord to the controller. • DO NOT disconnect the external battery before connecting the power cord. • Contact your clinician. [Connect Power] • The internal battery has limited time remaining or is unreliable. • Change the external battery or connect the power cord. • Contact your clinician. Alarm Type: Noncritical Screen Display Color Controller Message What it means What action to take Solid YELLOW back light Flashing alert symbol Periodic beep with escalating volume and vibration Able to mute alarm [Plug In Power Cord] • Disconnecting external battery without a power cord connected could risk pump stop • The internal battery has limited time remaining, is unreliable, disconnected or has failed AND • The external battery has less than 30 minutes runtime remaining or Is unreliable AND • Connect the power cord to the controller. • DO NOT disconnect the external battery before connecting the AC or DC power adapter. • Contact your clinician. Mute option: Two 5-minute mutes, then cannot be muted [Keep Power Connected] • Disconnecting external power could risk pump stop. • The internal battery has limited time remaining, is unreliable, or has failed. • DO NOT disconnect the external power. • If the external battery needs to be changed, connect the power cord first. • If the alarm has not resolved in one (1) hour, contact your clinician. Mute option: 5 minutes [Electrical] • A fault in the normal operation of the pump- to-controller electrical connection. • DO NOT change the controller • Check the pump cable and the connections for obvious damage. • Contact your clinician. Mute option: 15 minutes [Technical] • Controller component or power source malfunction. • Contact your clinician. Mute option: 15 minutes [High Power] • The pump power exceeds the alarm threshold setting. • Contact your clinician. Mute option: 15 minutes [Low Flow] • The pump flow exceeds the alarm threshold setting. • Contact your clinician. Mute option: 15 minutes Quick Reference Guide for Alarms (continued) Alarm Type: Noncritical Screen Display Color Controller Message What it means What action to take Solid YELLOW back light Flashing alert symbol Periodic beep with escalating volume and vibration Able to mute alarm [Suction] • A potential obstruction to pump flow has been detected • Contact your clinician. Mute option: 15 minutes [Connect Power] • No external power source is connected (for at least twenty (20) seconds). • Connect the power cord or a charged external battery Mute option: Two 5-minute mutes, then cannot be muted [Temperature] • The controller’s temperature is out of recommended range. • Move the controller to a room temperature environment and wait for the controller to return to normal temperature. • If the alarm persists for one (1) hour, contact your clinician. Mute option: 15 minutes [Change Battery] • The external battery has fifteen (15) minutes or less time remaining. • Change the external battery OR • Connect the AC or DC power adapter to the controller. Mute option: 15 minutes. [Connect Cap or Battery] A PAL Cap or external battery is not connected to the controller. • Attach the PAL Cap or an external battery to the controller to protect it from dust, dirt, fluids, or electrical interference. Mute option: 15 minutes Quick Reference Guide for Alarms (continued) All problems should be promptly reported to your clinician. Before you leave the hospital, add names and contact information below. It is very important to keep this information available in case something happens to you or to your Medtronic HVAD PAL ™ System. CLINICIAN CONTACT NameName OfficeOffice PagerPager MobileMobile IMPLANTING HOSPITAL Name Address Implanting Surgeon Name Phone Number AMBULANCE CompanyPhone Number The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries : HeartWare, HVAD, PAL, Power Tracking, controller Coiled Cable, Lavare Bluetooth ® is a registered trademark of Bluetooth SIG, Inc. and any use of this mark by Medtronic is under license. Velcro ® is a registered trademark of Velcro Companies PEEK ® is a registered trademark of Victrex USA, Inc. Images contained herein are representative and minor differences may appear between the actual product and what is shown in this manual. Contact Information 1.0 Introduction .....................................................................................................................1 1.1 Why You Should Read this Manual ....................................................2 1.2 Potential Benefits ................................................................................2 1.3 Potential Complications and Risks ....................................................3 1.…

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Users Manual

Medtronic HVAD PA L ™ System Clinician Manual 9 8 7 6 5 4 3 2 Care, Cleaning andMaintenance Alarms and Emergencies Patient Management Surgical Implant and Explant Monitor Peripherals and Accessories HVAD Pump 1 Introduction Overview Quick Reference Guide Table of Contents Table of Contents Quick Reference Guide for Alarms .........................................................................................................................1 1.0 Introduction ............................................................................................................................................................5 1.1 Introduction .........................................................................................................6 1.2 Indications for Use ..............................................................................................6 1.3 Contraindications ...............................................................................................7 1.4 Warnings ..............................................................................................................7 1.5 Precautions .......................................................................................................11 1.6 Potential Complications. .................................................................................16 1.7 Data Security ...................................................................................................16 2.0 HeartWare HVAD System Overview ....................................................................................................17 2.1 HeartWare HVAD Pump and Surgical Tools ..........................................................17 2.2 HeartWare Monitor ............................................................................................18 2.3 PAL Controller ..................................................................................................19 2.4 Controller External Power Sources ..................................................................19 2.5 Battery Charger ................................................................................................21 2.6 Carrying Cases and HeartWare Shower Bag ................................................21 3.0 HeartWare HVAD System Pump ............................................................................................................23 3.1 Principles of Operation ...................................................................................23 3.2 Physiologic Control Algorithms .......................................................................24 3.2.1 Flow Estimation ......................................................................................24 3.2.2 [Suction] Alarm ......................................................................................25 3.2.3 Power Tracking ......................................................................................26 3.2.4 Lavare Cycle ..........................................................................................28 4.0 System Peripherals and Accessories ................................................................................................29 4.1 PAL Controller ....................................................................................................29 4.1.1 Controller Overview ..............................................................................29 4.2 Controller Screens ............................................................................................30 4.2.1 Screen Overview ..................................................................................30 4.2.2 Operating States ...................................................................................34 4.2.3 Screen Navigation ................................................................................35 4.2.4 Screen Definitions ..................................................................................36 HeartWare HVAD Instructions for Use 9 8 7 6 5 4 3 2 1 Care, Cleaning andMaintenance Quick Reference Guide Alarms and Emergencies Patient Management Surgical Implant and Explant Monitor Peripherals and Accessories HVAD Pump Overview Introduction 4.3 Controller Connections....................................................................................40 4.3.1 Connections Overview .........................................................................40 4.3.2 HeartWare Monitor Connection ..........................................................41 4.3.3 Driveline (Pump Cable) Connection ..................................................42 4.3.4 AC or DC Adapter Connection ..........................................................44 4.3.5 External Battery and PAL Cap Connection .......................................47 4.4 Battery Charger ................................................................................................52 4.5 Internal Battery .................................................................................................54 4.6 Carrying Cases and HeartWare Shower Bag ................................................55 4.6.1 Overview ................................................................................................55 4.6.2 Sport Pack ..............................................................................................56 4.6.3 Accessories Bag ....................................................................................65 4.6.4 HeartWare Shower Bag ........................................................................66 5.0 Alarms and Emergencies .............................................................................................................................71 5.1 Alarm Overview ................................................................................................71 5.2 Critical Alarms ...................................................................................................72 5.3 No…

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Cover Letter(s)

May 6, 2020 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 To whom it may concern, I hereby authorize Tony Garcia of Murata to act on our behalf only for signing the Request for Confidentiality letter for this filing for FCC ID: LF5MCS3101CO. The exhibit being held confidential is the intellectual property of Murata. This authorization is limited to only the signing of the Request for Confidentiality letter. This authorization shall expire 12 months from original date. Sincerely, Christiaan Masson Regulatory Affairs Manager

Cover Letter(s)

Medtronic Medtronic, Inc. Cardiac Rhythm a nd Heart Failure 7000 Old Central Ave NE Minneapolis, MN 55432 USA www.medtronic.com office 763.526.0652 mobile 612.991.3108 Guillaume Girard Medtronic Inc. August 27, 2019 Federal C ommunications Commission Laboratory Division 7 435 Oakland Mills Rd C olumbia, MD 21045 Attn: Equipment Authorization and Compliance Branch Chief I, the undersigned, as the authorized signatory for Medtronic, Inc., grantee code LF5, hereby authorize Christiaan Masson, Regulatory Affairs Program Manager of Medtronic, Inc., to act on my behalf in all manners relatin g to application for equipment authorization, including signing of all documents relating to such application. Any and all acts c arried out by Christiaan Masson of Medtronic, Inc. on our behalf shall have the same effects as acts of my own. This authoriz ation shall be sent along with each application when filing with the F CC or TCB for certification of products covered by the above specified FCC ID. This authorization is valid until August 1, 2022. l f t here are any q uestions related to this letter, please c ontact me at Guillaume.girard®medtronic.com (mobile 61 2.991.3108). Respectfully, Guillaume Girard, Medtronic Inc.

Cover Letter(s)

April 23 rd , 2020 Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Subject: Confidentiality Request Letter pertaining to the certification of FCC ID No: LF5MCS3101CO 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. § 0.457(d) and 0.459, following grant of the application. The confidential information is embodied in circuit diagrams, detailed explanations, parts lists, 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. 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. 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. 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. 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. Long-Term Confidentiality The materials set forth in the following exhibits, which are segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Long-Term Confidentiality: - Internal Photos - Schematics - Block Diagram - Theory of Operation / Operational description Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN-55432, USA www.medtronic.com Following the Equipment Authorization Confidentiality Request Procedures as described in KDB Guidance 726920 D01 of April 8 th 2016, Internal Photos may be held Long-Term Confidential under the condition that the circuit board or internal components are not accessible to users. Medtronic’s PAL Controller for HVAD Pump, which is the subject of this future filing, is not available to the public. The devices are Class 3 devices regulated by the FDA and are available by prescription only by health care professionals. As the product us sealed with special torx screws, opening the device is possible, but not likely to occur. Therefore, the equipment to which this Long-Term Confidentiality request pertains satisfies this criterion. Short-Term Confidentiality The materials set forth in the following exhibits, which are also segregated from the non-confidential exhibits of the application, are the ones for which Medtronic requests Short-Term Confidentiality for a period of 180 days from the date of the grant: - External Photos - Test Setup Photos - User Manuals Respectfully, ____________________________ Christiaan Masson Regulatory Affairs Manager Medtronic, Inc. Endepolsdomein 5, 6229 GW, Maastricht, the Netherlands Email:[email protected] Phone: +31 43 356 6540

External Photos

External Pictures PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 1of 4 Controller – top Controller – front External Pictures PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 2of 4 Controller – left Controller – back External Pictures PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 3of 4 Controller – right Controller – bottom External Pictures PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 4of 4 Driveline connector – side Driveline connector – front

ID Label/Location Info

MEDTRONIC CONFIDENTIAL Specification Number Revision Page DL01658 02 1 of 2 Deliverabl e Device Regulatory Label Title DEVICE REGULATORY LABEL – PAL CONTROLLER US, CAN This document is the property of Medtronic, Inc. and must be accounted for. Information herein is confidential. Do not reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. Form FRM001244, Text-based Physical Specification, Revision 1B 1 Purpose This record describes the implementation for a Device Regulatory Label PAL Controller US and Canada. 2 Scope This document defines the minimum design specifications for the Device Regulatory Label PAL Controller US and Canada. All specifications are located in Section 3; all other sections are for reference purposes only. 3 Specifications This section contains the artwork for the Device Regulatory Label. 3.1 Graphics: Per the supplied artwork file (zip file). All borders are represented by line-art. 3.2 Colors: a. Background, Black per the supplied color chip Infinity LTL number RX32001. b. Graphics, Reverse Process White, Blue PMS 3005c and Red PMS 1807c. See artwork for color location. 3.3 Label Materials and Dimensions: Per CMP02869. 3.4 Shelf Life: Upon receipt, this component shall have a minimum of 12 months of shelf life remaining determined by the Use-Before-Date. 3.5 Labeling: Label each package with part number, revision and the Use-Before-Date. 3.6 Packaging: Bulk package in polybags as to prevent damage and foreign material contamination. 3.7 Workmanship: Graphic content to be legible and free of ink voids and smudges. Label Artwork – For reference only not to scale Printed By:Ledebuhr, Aaron (aledebuhr)Title Block.Lifecycle Phase:Pre-Prod DL01658Rev:02 CO33021 Released:2020-01-23 16:20:21 GMT MEDTRONIC CONFIDENTIAL Specification Number Revision Page DL01658 02 2 of 2 Deliverabl e Device Regulatory Label Title DEVICE REGULATORY LABEL – PAL CONTROLLER US, CAN This document is the property of Medtronic, Inc. and must be accounted for. Information herein is confidential. Do not reproduce it, reveal it to unauthorized persons or send it outside Medtronic without proper authorization. Form FRM001244, Text-based Physical Specification, Revision 1B 4 Abbreviations, Acronyms, and Definitions Term Definition PMS Pantone Matching System for color 5 Change History Revision Description of Change 01 Initial Release 02 Delete humidity symbol from artwork Appendix A None Printed By:Ledebuhr, Aaron (aledebuhr)Title Block.Lifecycle Phase:Pre-Prod DL01658Rev:02 CO33021 Released:2020-01-23 16:20:21 GMT

Operational Description

Antenna Information PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 1of 4 The purpose of this document is to record the antenna information for the products identified below. Products PAL Controller for HeartWare HVAD Pump 1. General antenna information Table 1: General antenna information Telemetry: BluetoothLow EnergyAntenna Type:Monopole Manufacturer:Murata Model number:LBCA2HNZYZ Connection with transmitter:Integrated Antenna Gain:-0.6 dBi Polarization:Linear Antenna Information PAL Controller for HeartWare HVAD Pump Medtronic ConfidentialPage 2of 4 2. Antenna assembly drawing Source: Antenna ZY-L116 Top Antenna ZY-L116 Bottom Top Bottom

RF Exposure Info

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. More: https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/14-commerce-country-chart/fileT Medtronic, Inc. PAL™ Controller for HeartWare™ HVAD™ Pump Model Number: MCS3101CO FCC 2.1093:2020 Bluetooth Low Energy Report # MDTR0798.7 NVLAP Lab Code: 200630 CERTIFICATE OF EVALUATION 2018-09-14 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. 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. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: Tuesday, January 28, 2020 Medtronic, Inc. EUT: PAL™ Controller for HeartWare™ HVAD™ Pump Model Number: MCS3101CO RF Exposure Evaluation Standards Specification Method FCC 2.1093:2020 FCC 447498 D01 General RF Exposure Guidance v06 Results Method Clause Description Applied Results Comments 4.3.1 SAR Test Exclusion Yes Pass None Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. MDTR0798.7EAR-Controlled Data2/9 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. MDTR0798.7EAR-Controlled Data3/9 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 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 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / 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. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. MDTR0798.7EAR-Controlled Data4/9 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. MDTR0798.7EAR-Controlled Data5/9 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment Under Evaluation Information Company Name: Medtronic, Inc. Address: 710 Medtronic Parkway NE City, State, Zip: Minneapolis, MN 55432 Evaluation Requested By: Jeffrey Brown EUT: PAL™ Controller for HeartWare™ HVAD™ Pump, Model MCS3101CO Date of Evaluation: Tuesday, January 28, 2020 Information Provided by the Party Requesting the Evaluation Functional Description of the Equipment: Controller: The controller transmits and receives data from the companion device via Bluetooth Low Energy. The BLE module is located within the controller. System: The PAL Commercial Heart Ventricular Assist Device (HVAD) is composed of several components, including: the Controller, the Monitor that is used by the Clinician to program the controller; and power sources in the form of an ext…

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Test Report

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Medtronic, Inc. PAL™ Controller for HeartWare™ HVAD™ Pump Model Number: MCS3101CO FCC 15.247:2019 Bluetooth Low Energy Report # MDTR0798 Rev. 1 NVLAP LAB CODE: 200881-0 CERTIFICATE OF TEST 2018-09-14 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. 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. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: June 20, 2019 Medtronic, Inc. PAL™ Controller for HeartWare™ HVAD™ Pump Model: MCS3101CO Radio Equipment Testing Standards Specification Method FCC 15.207:2019 FCC 15.247:2019 ANSI C63.10:2013 KDB 558074 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions Yes Pass 11.6 Duty Cycle Yes Pass 11.8.2 Occupied Bandwidth Yes Pass 11.9.1.1 Output Power Yes Pass 11.9.1.1 Equivalent Isotropic Radiated Power Yes Pass 11.10.2 Power Spectral Density Yes Pass 11.11 Band Edge Compliance Yes Pass 11.11 Spurious Conducted Emissions Yes Pass 11.12.1, 11.13.2, 6.5, 6.6 Spurious Radiated Emissions Yes Pass Deviations From Test Standards None Approved By: Eric Brandon, Department Manager Report No. MDTR0798 Rev. 12/48 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None 01 Updated the testing objective 2020-01-28 8 Report No. MDTR0798 Rev. 13/48 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 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 -…

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Contact Information

Applicant

Guillaume Girard(Sr. RF Regulatory Program Manager)
[email protected]763-526-0652Fax: 651-367-0603

Test Firm

Element Materials Technology MinneapolisRenee Walker
[email protected]503-844-4066Fax: 503-844-3826

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz600.00 µW
Confidentiality
Long Term
Grant Notes
Output power listed is conducted. The antenna(s) used for the transmitter must not be collocated or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures.

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