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LF5NIMPAT1NIM Patient Interface

Medtronic, Inc.
NIM Patient Interface - FCC ID LF5NIMPAT1 - Medtronic, Inc.
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Feb 19, 2020
Application Purpose
Original Equipment
Date of Application
Feb 18, 2020
Equipment Note
NIM Patient Interface
Frequency Range
2402.00000000 - 2480.00000000
Company
Medtronic, Inc.
Country
United States

Documents & Files

Select a file to view

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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Internal Photos

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RF Exposure Info

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Test Report

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Document Text

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

Users Manual

Nerve Integrity Monitor NIM Vital ™ Instructions for use FCC use only, not for Medical use The following are trademarks or registered trademarks of Medtronic in the United States and other countries: NIM Vital™, APS™, Nervassure™, and NerveTrend™. All other trademarks, service marks, registered trademarks, or registered service marks are the property of their respective owners in the United States and other countries. The information contained in this document is accurate at time of publication. Medtronic reserves the right to make changes to the product described in this manual. Refer to manuals.medtronic.com for the current version. FCC use only, not for Medical use 1 Nerve Integrity Monitor Table of Contents Intended use 2 Indications for use 2 Device description 2 Contraindications 2 Warnings and precautions 2 Warnings ...........................................................................................................................................................................................2 Precautions ......................................................................................................................................................................................3 NIM quick monitoring set-up 4 The basics of what you will see and hear during monitoring .......................................................................................5 Unboxing and installing the system 5 Setting up the NIM Vital console .............................................................................................................................................6 Installing the NIM Vital battery .................................................................................................................................................6 Setting up the NIM Vital cart .....................................................................................................................................................6 Connecting NIM Vital accessories ............................................................................................................................................6 First time user interface setup ..................................................................................................................................................6 Set the time zone, date, time, and date/time format .......................................................................................................6 Create a surgeon profile ..............................................................................................................................................................7 Saving to a surgeon profile .............................................................................................................................................7 Save custom profiles to a USB drive ............................................................................................................................7 Import custom profiles from a USB drive ..................................................................................................................7 Components 8 Power Cords .................................................................................................................................................................................11 Software overview 11 Turning the system on ..............................................................................................................................................................11 SETUP tab ......................................................................................................................................................................................11 Select user profiles or default categories ..........................................................................................................................13 Select a default procedure ...........................................................................................................................................13 Select a user profile.........................................................................................................................................................13 Connect Devices screen ................................................................................................................................................14 Check Electrode screen .................................................................................................................................................14 MONITORING tab ........................................................................................................................................................................15 EMG Display .......................................................................................................................................................................15 EMG display area .............................................................................................................................................................16 Recognizing stimulus artifacts ....................................................................................................................................16 Understanding and recognizing other artifacts ...................................................................................................17 MONITORING tab right panel ......................................................................................................................................17 MONITORING tab Left panel ........................................................................................................................................18 NerveTrend (only available in select procedures) ................................................................................................20 NIM Vital bottom panel ........................…

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Users Manual

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA medtronic.com +1 800 874 5797 Authorized Representative in the European Community Medtronic B.V. Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31, Case Postale 84 CH - 1131 Tolochenaz, Switzerland www.medtronic.eu Tel. +41-21-802-7000 Fax +41-21-802-7900 Asia-Pacific Medtronic International Ltd. Suite 1106-11, 11/F, Tower 1, The Gateway, 25 Canton Road, Tsimshatsui, Kowloon, Hong Kong Tel. +852-2919-1300 Fax +852-2891-6830 M215375A205 B 2020-02 © 2020 Medtronic, Inc. EC REP NIM4CPB1 Communications Regulation Reference Sheet Communications Regulations The following is a list of communications regulations that apply to the Model NIM4CPB1. United States Compliance FCC ID: LF5NIMPAT1 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. (3)This product complies with FCC and ISED radiation exposure limits set forth for an uncontrolled environment. The equipment should be operated with minimum distance of 20cm between the radiator and your body. Complies with IDA Standards DA103452 Canada HIDF15000146 IMPORTANT: Changes or modifications to this product not authorized by Medtronic, Inc., could void the FCC Certification and negate your authority to operate this product. Canada Compliance IC: 3408D-NIMPAT1 This device complies with ith Innovation, Science and Economic Development Canada’s license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. Singapore Compliance Dealer License # DA103452 This product complies with IDA Standards. 该产品符合 IDA 标准。 Malaysia Compliance HIDF15000146 This product conforms to Malaysia Radio Requirement. Produk ini mematuhi Keperluan Radio Malaysia. Australia and New Zealand Compliance This product conforms to Australia and New Zealand Radio Requirements. European Union Compliance Conformité Européenne (European Conformity) Hereby, Medtronic declares that this Radio Equipment Model number NIM4CPB1 is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.MedtronicCompliance.eu This product operates in the 2.4-2.4835 GHz band with an RF output power of less than 10 mW e.i.r.p. Bulgarian С настоящото Medtronic декларира, че това радиооборудване модел номер NIM4CPB1 е в съответствие с Директива 2014/53/ЕС. Пълният текст на ЕС декларацията за съответствие е на разположение на следния интернет адрес: www.MedtronicCompliance.eu Този продукт работи в честотна лента от 2,4–2,4835 GHz с РЧ изходяща мощност под 10 mW еквивалентна изотропно излъчена мощност (e.i.r.p). Czech Společnost Medtronic tímto prohlašuje, že toto radiové zařízení, číslo modelu NIM4CPB1, odpovídá požadavkům směrnice 2014/53/EU. Úplný text EU Prohlášení o shodě je k dispozici na následující internetové adrese: www.MedtronicCompliance.eu Tento výrobek používá frekvenční pásmo 2,4–2,4835 GHz, přičemž výstupní RF výkon je nižší než 10 mW EIRP. Danish Herved erklærer Medtronic, at dette radioudstyr med modelnummer NIM4CPB1 overholder bestemmelserne i radioudstyrdirektivet 2014/53/EF. Den fulde tekst til EU’s overensstemmelseserklæring er tilgængelig på følgende hjemmeside: www.MedtronicCompliance.eu Dette produkt fungerer på 2,4-2,4835 GHz-båndet med en radiofrekvensudgangseffekt på mindre end 10 mW e.i.r.p. German Hiermit erklärt Medtronic, dass dieses Funkgerätmodell Nummer NIM4CPB1 der Richtlinie 2014/53/EU entspricht. Der vollständige Text der EU-Konformitäts- erklärung steht unter der folgenden Internetadresse zur Verfügung: www.MedtronicCompliance.eu Dieses Produkt arbeitet im 2,4–2,4835-GHz-Band mit einer HF-Ausgangsleistung von weniger als 10 mW EIRP. Greek Δια του παρόντος, η Medtronic δηλώνει ότι ο παρών ραδιοεξοπλισμός με αριθμό Μοντέλου NIM4CPB1 βρίσκεται σε συμμόρφωση με την Οδηγία 2014/53/ΕΕ. Το πλήρες κείμενο της δήλωσης συμμόρφωσης για την Ευρωπαϊκή Ένωση είναι διαθέσιμο στην ακόλουθη διαδικτυακή διεύθυνση: www.MedtronicCompliance.eu Το παρόν προϊόν λειτουργεί στη ζώνη των 2,4-2,4835 GHz με ισχύ εξόδου ραδιοσυχνοτήτων (RF) μικρότερη από 10 mW e.i.r.p. (ισοδύναμη ισοτροπικά ακτινοβολούμενης ισχύς). Spanish Por la presente, Medtronic declara que este equipo de radio, modelo número NIM4CPB1, cumple la Directiva 2014/53/UE. El texto completo de la Declaración de Conformidad UE está disponible en la siguiente dirección de internet: www.MedtronicCompliance.eu Este producto funciona en la banda de frecuencia de 2,4-2,4835 GHz con una potencia de salida de RF (PIRE) de menos de 10 mW. Estonian Medtronic kinnitab, et see raadioseade, mudel number NIM4CPB1, on vastavuses direktiiviga 2014/53/EL. Selle EL-i vastavusdeklaratsiooni täistekst on kättesaadav veebiaadressil www.MedtronicCompliance.eu See toode töötab sagedusribal 2,4–2,4835 GHz, kiirgusliku väljundvõimsusega mitte alla 10 mW ekvivalentset isotroopset kiirgusvõimsust (e.i.r.p.). Finnish Medtronic vakuuttaa täten, että tämä radiolaite, mallinumero NIM4CPB1, vastaa direktiiviä 2014/53/EU. EU-vaatimustenmukaisuusvakuutuksen koko tekst…

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Cover Letter(s)

Date: 2/18/2020 Declaration letter - KDB 996369 To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Product: NIM Patient Interface FCC ID: LF5NIMPAT1 We, Medtronic, Inc., declare that the original test reports of the Bluetooth module (FCC lD: SQGBL652) accurately represents test results under the new application FCC lD: LF5NIMPAT1. The module FCC lD: SQGBL652 is used and integrated according module supplier application notes and represents the new device, FCC lD: LF5NIMPAT1. The following list shows the modules with the referring FCC lD and the associated FCC Test reports: Bluetooth 4.2 module (BLE only) FCC lD: SQGBL652 Name of Grantee: Laird Technologies FCC Test Reports FR662202AE If you have any question or concerns, please contact us. Guillaume Girard Phone/Fax: 765 526 0652 Email: [email protected]

Cover Letter(s)

SCS-F19: Confidentiality Request Letter Page 1 of 2 Rev 6.0 775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Confidentiality Request Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Adding CFR 2.459 (obsolete) 1.0 2.0 August – 11 - 2008 Updated company template & Added text box (obsolete) 2.0 3.0 Jan-31-2012 Added IC confidentiality letter form (obsolete) 3.0 4.0 March-26-2015 Corrections to STC form. Added reference to KDB (obsolete) 4.0 5.0 Nov-19-2015 Updated company logo (current) 5.0 6.0 Jun-26-2019 SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 6.0 2/18/2020 To: Federal Communications Commission Office of Engineering and Technology Equipment Authorization Division 7345 Oakland Mills Road Columbia, Maryland 21046 Subject: Short Term Confidentiality Request for FCC ID: LF5NIMPAT1 T o Whom It May Concern: Pursuant to sections 0.457 and 0.459 of CFR 47, and to avoid premature release of sensitive information prior to marketing or release of the product to the public, the applicant requests the following documents contained in this certification application be temporarily withheld from public disclosure for an initial period of 45 or 180 days; or for a specified date of / / not to exceed 180 days from the Grant Date. See KDB 726920. -e.g. User Manual -e.g. Internal Photos -e. g. Test Setup photos -e.g. External Photos The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. Sincerely, Guillaume Girard Phone/Fax: 765 526 0652 Email: guillau [email protected]

Cover Letter(s)

SCS-F18: Project and Product Certification Representative Authorization Letter Page 1 of 2 Rev 6.0 775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: [email protected] Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Revision History Approved Date From To Initial Release (obsolete) 1.0 1.0 Nov-14-2006 Revised wording (obsolete) 1.0 2.0 Sept–25-2007 Updated company template (obsolete) 2.0 3.0 Jan-31-2012 Updated letter information (obsolete) 3.0 4.0 May-23-2014 Added FCC ID field (obsolete) 4.0 5.0 Sep-16-2014 Updated company name & logo (current) 5.0 6.0 Jun-27-2018 SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 6.0 2/18/2020 To: BVCPS, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Product Certification Representative Authorization Letter We, Medtronic, Inc.hereby authorize Bureau Veritas Consumer Product Services, Inc. to act as a Certification Body for certifying for the following project(s): FCC ID: LF5NIMPAT1 Product Description: NIM Patient Interface Model: NIM4CPB1 Sincerely, Guillaume Girard / title Phone/Fax: 765 526 0652 [email protected]

External Photos

Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 1 of 6 Medtronic Xomed Inc. Confidential Physical Representation Reference Brand Name: NIM Vital™ Patient Interface – Nerve Monitoring System Model: NIM4CPB1 Serial number: P1910095 Table of Contents A. Physical Representation Reference ................................................................................................... 1 B. NIM Vital Patient Interface Top View with dimensions ....................................................................... 2 C. NIM Vital Patient Interface Bottom View ............................................................................................ 2 D. NIM Vital Patient Interface Bottom View with dimensions ................................................................. 3 E. NIM Vital Patient Interface Right Side View ....................................................................................... 3 F. NIM Vital Patient Interface Left Side View ......................................................................................... 4 G. NIM Vital Patient Interface Rear View ................................................................................................ 4 H. NIM Vital Patient Interface Rear View with dimensions ..................................................................... 5 I. NIM Vital Patient Interface Front View ............................................................................................... 6 Table of Figures Figure 1 NIM Vital Patient Interface NIM4CPB1 Top View with dimensions ................................................ 2 Figure 2 NIM Vital Patient Interface NIM4CPB1 Bottom View ...................................................................... 2 Figure 3 NIM Vital Patient Interface NIM4CPB1 Bottom View with dimensions ........................................... 3 Figure 4 NIM Vital Patient Interface NIM4CPB1 Right Side View ................................................................ 3 Figure 5 NIM Vital Patient Interface NIM4CPB1 Left Side View ................................................................... 4 Figure 6 NIM Vital Patient Interface NIM4CPB1 Rear View ......................................................................... 4 Figure 7 NIM Vital Patient Interface NIM4CPB1 Rear View with dimensions .............................................. 5 Figure 8 NIM Vital Patient Interface NIM4CPB1 Front View ......................................................................... 6 Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 2 of 6 Medtronic Xomed Inc. Confidential NIM Vital Patient Interface Top View with dimensions Figure 1 NIM Vital Patient Interface NIM4CPB1 Top View with dimensions NIM Vital Patient Interface Bottom View Figure 2 NIM Vital Patient Interface NIM4CPB1 Bottom View Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 3 of 6 Medtronic Xomed Inc. Confidential NIM Vital Patient Interface Bottom View with dimensions Figure 3 NIM Vital Patient Interface NIM4CPB1 Bottom View with dimensions NIM Vital Patient Interface Right Side View Figure 4 NIM Vital Patient Interface NIM4CPB1 Right Side View Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 4 of 6 Medtronic Xomed Inc. Confidential NIM Vital Patient Interface Left Side View Figure 5 NIM Vital Patient Interface NIM4CPB1 Left Side View NIM Vital Patient Interface Rear View Figure 6 NIM Vital Patient Interface NIM4CPB1 Rear View Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 5 of 6 Medtronic Xomed Inc. Confidential NIM Vital Patient Interface Rear View with dimensions Figure 7 NIM Vital Patient Interface NIM4CPB1 Rear View with dimensions Model NIM4CPB1 NIM Vital™ Patient Interface, External Pictures Surgical Technologies Page 6 of 6 Medtronic Xomed Inc. Confidential NIM Vital Patient Interface Front View Figure 8 NIM Vital Patient Interface NIM4CPB1 Front View

ID Label/Location Info

� Medtronic LABEL MASTER REF NIM4CPB1 x1 NIM Vital ™ Patient Interface 4 Channel NIMVlta,.. C!) iiim [ O•� ·O I Medtronic Xomed, Inc., 6743 Southpolnt Drive North Jacksonville, FL 32216-0980 USA - _ 20 ·c � 2019-08-07 FCC ID: LFSNIMPAT1 IC ID: 3408D NIMPAT1 I + 5 0 " C ]lOnly L'h OlJ ( E: � jLoTI 0999999999 SN: x123456789 11111111 �1111111111111 Ill 111111 (01 )00763000002985(21 )X 123456789 M986055A001 B 0001 AMOUNT ISSUED------ LABEL VERIFICATION OPERATOR INITIAL Variable information is representative only DATE

Internal Photos

Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 1 of 8 Medtronic Xomed Inc. Confidential A. Physical Representation Reference Brand Name: NIM Vital™ Patient Interface – Nerve Monitoring System Model: NIM4CPB1 S/N: P1910095 Table of Contents A. Physical Representation Reference ................................................................................................... 1 B. NIM Vital Patient Interface Top View. ................................................................................................ 2 C. NIM Vital Patient Interface Mainboard Bottom View with Bottom Enclosure off. ............................... 2 D. NIM Vital Patient Interface Back View with Bottom Enclosure off. .................................................... 3 E. NIM Vital Patient Interface Front View with Bottom Enclosure off. .................................................... 4 F. NIM Vital Patient Interface Left Side View with Bottom Enclosure off. .............................................. 5 G. NIM Vital Patient Interface Right Side View with Bottom Enclosure off. ............................................ 5 H. NIM Vital Patient Interface Disassembled. ......................................................................................... 6 I. NIM Vital Patient Interface Mainboard Top View ............................................................................... 7 J. NIM Vital Patient Interface Mainboard Radio Module ........................................................................ 8 Table of Figures Figure 1 NIM Vital Patient Interface NIM4CPB1 Top View ........................................................................... 2 Figure 2 NIM Vital Patient Interface NIM4CPB1 Mainboard Bottom View with Bottom Enclosure off ......... 2 Figure 3 NIM Vital Patient Interface NIM4CPB1 Back View with Bottom Enclosure off ............................... 3 Figure 4 NIM Vital Patient Interface NIM4CPB1 Front View with Bottom Enclosure off .............................. 4 Figure 5 NIM Vital Patient Interface NIM4CPB1 Left Side View with Bottom Enclosure off ......................... 5 Figure 6 NIM Vital Patient Interface NIM4CPB1 Right Side View with Bottom Enclosure off ...................... 5 Figure 7 NIM Vital Patient Interface NIM4CPB1 Disassembled View .......................................................... 6 Figure 8 NIM Vital Patient Interface NIM4CPB1 Mainboard Top View ......................................................... 7 Figure 9 NIM Vital Patient Interface NIM4CPB1 Mainboard View Radio Module ......................................... 8 Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 2 of 8 Medtronic Xomed Inc. Confidential B. NIM Vital Patient Interface Top View. Figure 1 NIM Vital Patient Interface NIM4CPB1 Top View C. NIM Vital Patient Interface Mainboard Bottom View with Bottom Enclosure off. Figure 2 NIM Vital Patient Interface NIM4CPB1 Mainboard Bottom View with Bottom Enclosure off Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 3 of 8 Medtronic Xomed Inc. Confidential D. NIM Vital Patient Interface Back View with Bottom Enclosure off. Figure 3 NIM Vital Patient Interface NIM4CPB1 Back View with Bottom Enclosure off Antenna Wired Connector Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 4 of 8 Medtronic Xomed Inc. Confidential E. NIM Vital Patient Interface Front View with Bottom Enclosure off. Figure 4 NIM Vital Patient Interface NIM4CPB1 Front View with Bottom Enclosure off Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 5 of 8 Medtronic Xomed Inc. Confidential F. NIM Vital Patient Interface Left Side View with Bottom Enclosure off. Figure 5 NIM Vital Patient Interface NIM4CPB1 Left Side View with Bottom Enclosure off G. NIM Vital Patient Interface Right Side View with Bottom Enclosure off. Figure 6 NIM Vital Patient Interface NIM4CPB1 Right Side View with Bottom Enclosure off Antenna Antenna Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 6 of 8 Medtronic Xomed Inc. Confidential H. NIM Vital Patient Interface Disassembled. Figure 7 NIM Vital Patient Interface NIM4CPB1 Disassembled View Antenna Wired Connector Laird Radio Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 7 of 8 Medtronic Xomed Inc. Confidential I. NIM Vital Patient Interface Mainboard Top View Figure 8 NIM Vital Patient Interface NIM4CPB1 Mainboard Top View Antenna Laird Radio Model NIM4CPB1 NIM Vital™ Patient Interface, Internal Pictures Surgical Technologies Page 8 of 8 Medtronic Xomed Inc. Confidential J. NIM Vital Patient Interface Mainboard Radio Module Figure 9 NIM Vital Patient Interface NIM4CPB1 Mainboard View Radio Module

RF Exposure Info

Report No.: FCC_MPE_SL20020301-MED-020 Page No. 1 / 6 Report Format Version: 6.1.1 RF Exposure Report Report No.: FCC_MPE_SL20020301-MED-020 NIM4CM01 FCC ID: NIM4CPB1 FCC ID: LF5NIMVITAL1 LF5NIMPAT1 Models: NIM4CM01, NIM4CPB1 Issued Date: 02/18/2020 Applicant: Medtronic, Inc. Address: 710 Medtronic Parkway N.E, Minneapolis, MN 55432 Manufacturer: Medtronic, Inc. Address: 710 Medtronic Parkway N.E, Minneapolis, MN 55432 Issued By: Bureau Veritas Consumer Products Services, Inc. Lab Address: 775 Montague Expressway, Milpitas, CA 95035 FCC Registration / Designation Number: 540430 This report is for your exclusive use. Any copying or replication of this report to or for any other person or entity, or use of our name or trademark, is permitted only with our prior written permission. This report sets forth our findings solely with respect to the test samples identified herein. The results set forth in this report are not indicative or representative of the quality or characteristics of the lot from which a test sample was taken or any similar or identical product unless specifically and expressly noted. Our report includes all of the tests requested by you and the results thereof based upon the information that you provided to us. You have 60 days from date of issuance of this report to notify us of any material error or omission caused by our negligence, provided, however, that such notice shall be in writing and shall specifically address the issue you wish to raise. A failure to raise such issue within the prescribed time shall constitute your unqualified acceptance of the completeness of this report, the tests conducted and the correctness of the report contents. Unless specific mention, the uncertainty of measurement has been explicitly taken into account to declare the compliance or non-compliance to the specification. The report must not be used by the client to claim product certification, approval, or endorsement by A2LA or any government agencies. Report No.: FCC_MPE_SL20020301-MED-020 Page No. 2 / 6 Report Format Version: 6.1.1 Table of Contents Release Control Record .................................................................................................................................. 3 1 Certificate of Conformity ...................................................................................................................... 4 2 RF Exposure .......................................................................................................................................... 5 2.1 Limits for Maximum Permissible Exposure (MPE) .............................................................................. 5 2.2 MPE Calculation Formula ................................................................................................................... 5 2.3 Classification ....................................................................................................................................... 5 2.4 Antenna Gain ...................................................................................................................................... 5 2.5 Calculation Result of Maximum Conducted Power ............................................................................. 6 3 Conclusion ................................................................................................ Error! Bookmark not defined. Report No.: FCC_MPE_SL20020301-MED-020 Page No. 3 / 6 Report Format Version: 6.1.1 Release Control Record Issue No. Description Date Issued FCC_MPE_SL20020301-MED-020 Orignal Release 02/18/2020 Report No.: FCC_MPE_SL20020301-MED-020 Page No. 4 / 6 Report Format Version: 6.1.1 1 Certificate of Conformity Product: NIM Patient Interface / NIM Vital Console Brand: Medtronic Applicant: Medtronic, Inc. Standards: FCC Part 2 (Section 2.1093) KDB 447498 D01 General RF Exposure Guidance v06 IEEE C95.1-1992 The above equipment has been tested by Bureau Veritas Consumer Products Services, Inc., Milpitas Branch, and found compliance with the requirement of the above standards. The test record, data evaluation & Equipment Under Test (EUT) configurations represented herein are true and accurate accounts of the measurements of the sample’s EMC characteristics under the conditions specified in this report. Prepared by : , Date: 02/18/2020 Deon Dai / Test Engineer Approved by : , Date: 02/18/2020 Chen Ge / Engineer Reviewer Report No.: FCC_MPE_SL20020301-MED-020 Page No. 5 / 6 Report Format Version: 6.1.1 2 RF Exp…

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Contact Information

Applicant

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

Test Firm

Bureau Veritas Consumer Products Services, Inc.Sarb Shelopal
[email protected]+1 925 963 4420

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz3.00 mW
Confidentiality
Long Term
Grant Notes
Output power listed is conducted. This device must be installed to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. Installers and end-users must be provided with installation and operating instructions for satisfying RF exposure compliance.

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