
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
ENERGYA 4LV CRT-D 3744 IMPLANT MANUAL Implantable cardioverter defibrillator with cardiac resynchronization therapy 4LV CRT-D 3744 model Intended audience This manual is intended for use by professionals trained or experienced in device implant and/or follow-up procedures. Training for users The following instructions for use are for informational purpose only. Each medical professional is responsible for their medical training and experience and should apply the following instructions according to the best clinical practices and patient condition. 10 kOhm LV, IS4-LLLL RV, DF4 - LLHH RV, DF4 - LLHH RA, IS-1 BI RA, IS-1 BI ENERGYA 4LV CRT-D - DF4 / IS4 2.66 V > 3.2 V Leads connection - ENERGYA 4LV CRT-D 3744 model - DF4 / IS4 2.66 V > 3.2 V Battery depletion Reminder 2.62 V > 3.2 V voltage years RRT BOS blank TABLE OF CONTENTS 1.GENERAL DESCRIPTION AND COMPATIBLE DEVICES......................................8 2.INTENDED PURPOSE AND TARGETED POPULATION......................................10 Intended purpose.....................................................................................................10 Indications................................................................................................................10 Targeted population.................................................................................................10 Intended users..........................................................................................................10 3.CONTRAINDICATIONS...........................................................................................11 Contraindication for patient implantation..................................................................11 Contraindication for use under medical environments.............................................11 Adverse events, risks and side-effects.....................................................................11 4.WARNINGS AND PRECAUTIONS..........................................................................14 Warnings to patients.................................................................................................14 Risks related to medical environment......................................................................15 Sterilization, storage and handling...........................................................................17 Implantation and device programming.....................................................................17 Lead evaluation and lead connection.......................................................................18 Generator explant and disposal...............................................................................19 5.ADVERSE EVENTS.................................................................................................20 MSP study................................................................................................................20 6.CLINICAL STUDIES................................................................................................22 MSP clinical study....................................................................................................22 7.PATIENT INFORMATION........................................................................................26 8.PATIENT SELECTION AND TREATMENT.............................................................27 Individualization of treatment....................................................................................27 Specific patient populations......................................................................................27 9.PATIENT COUNSELING INFORMATION...............................................................29 10.DECLARATION OF CONFORMITY........................................................................30 11.PHYSICIAN GUIDELINES.......................................................................................31 Physician training.....................................................................................................31 Directions for use.....................................................................................................31 Maintaining device quality........................................................................................31 V-V Programming Recommendation........................................................................32 12.HOW SUPPLIED......................................................................................................33 Sterility......................................................................................................................33 Warranty and replacement policy.............................................................................33 13.DEVICE DESCRIPTION..........................................................................................34 2.1. 2.2. 2.3. 2.4. 3.1. 3.2. 3.3. 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 5.1. 6.1. 8.1. 8.2. 11.1. 11.2. 11.3. 11.4. 12.1. 12.2. ENERGYA – UA15215A5 14.IMPLANT PROCEDURE..........................................................................................36 Necessary equipment...............................................................................................36 Packaging.................................................................................................................36 Optional equipment..................................................................................................37 Opening the package...............................................................................................37 Prior to implantation.................................................................................................38 Device placement.....................................................................................................38 Choosing the type of lead.........................................................................................39 Shock configuration (+ -> -)........…
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Rev 1/26/2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: April 2, 2024 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: YSGCRTD3744 SORIN CRM (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Link: List of Equipment and Services Covered By Section 2 of The Secure Networks Act Sincerely, SORIN CRM Mr Dwyndl NELMS Manager, Commercial Quality Signature: Rev 1/26/2023 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: April 2, 2024 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: YSGCRTD3744 SORIN CRM (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List (as a specifically named entity or any of its subsidiaries or affiliates) as an entity producing “covered” equipment. Link: List of Equipment and Services Covered By Section 2 of The Secure Networks Act Sincerely, SORIN CRM Mr Dwyndl NELMS Manager, Commercial Quality Signature:
Letter of Agency April 2, 2024 To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Timco Engineering, Inc. 13146 NW 86th Drive, Suite 400 Alachua, FL 32615- United States We, the undersigned SORIN CRM hereby authorizes Majid MOURZAGH, LCIE SUD EST, to act on our behalf in all matters relating to all processes required for FCC certification of our devices. Any and all acts carried out by the above agent on our behalf shall have the same effects as acts of our own. This authorization is valid until: 30 September 2024 If you have any questions regarding this authorization, let us know please. Sincerely, Mr Dwyndl NELMS Manager, Commercial Quality Signature:
COVER LETTER SORIN CRM – ENERGYA 4LV CRT-D 3744 FCC ID: YSGCRTD3744 April 2, 2024 This report concerns: File : Original Grant SubPart: SubPart 15C Equipment type : Defibrillator Request issue of grant : __ Immediately upon completion of review ___ Defer grant per 47 CFR 0.457(d)(1)(ii) until ____ date _____. Company Name agrees to notify the Commission by _____date_____ of the intended date of announcement of the product so that the grant can be issued on that date. Confidentiality of grant : __ Applicant requests the existence of this grant to be kept confidential until ____date____. The announcement of this product before this date via freedom of information would be detrimental to Company Name, and therefore must be considered a business secret. Public announcement of this product will not be made prior to this date. (Max. 60 days after grant issued). Limits used : (check one) CISPR 22: ______ Part15: ______ Measurement procedure used is ANSI C63.4-2014 / C63.10-2013 unless another is specified. Other test procedure : ____________________________________________________ Application for verification Applicant for this device Prepared by : Majid MOURZAGH LCIE Sud-Est ZI Centr’Alp – 170, rue de Chatagnon 38430 MOIRANS - France Ph. : 33 4 76 07 36 36 Fax : 33 4 76 55 90 88 e-mail : Majid [email protected] FRN : 0005-0971-18 Dwyndl NELMS SORIN CRM Parc d'affaires NOVEOS, 4 Avenue de Réaumur 92140 - CLAMART - France Ph. : 1-901-867-4557 e-mail: [email protected] FRN : 0020190344 Signature : Signature : *Not to be filed with Equipment Authorization Branch of FCC unless requested Report format prepared by the Information Technology Industry Council (ITI) ESC-5 and reviewed by FCC staff in 1994
CONFIDENTIALITY REQUEST To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046-1609 Cc: Timco Engineering, Inc. 13146 NW 86th Drive, Suite 400 Alachua, FL 32615- United States April 2, 2024 Subject: Confidentiality request FCC ID: YSGCRTD3744 SORIN CRM requests, pursuant to 47CFR 0.457 and 0.459, post grant confidentiality for portions of the material contained in this application. The following document regarding this submission for FCC ID: YSGCRTD3744 shall be kept confidential: LONG-TERM CONFIDENTIALITY: 1. Block Diagram description of the equipment (file: Block Diagram - YSGCRTD3744.pdf) 2. Operational description of the equipment (file: Operational Description -YSGCRTD3744.pdf) 3. Schematic Diagram of the equipment (file: Schematic -YSGCRTD3744.pdf) 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. The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Responsible party: Mr Dwyndl NELMS Title: Manager, Commercial Quality Signature:
Technical Documentation External Photos ENERGYA 4LV CRT-D 3744 Triple chamber defibrillators FCC ID: YSGCRTD3744 Publication History Version Date Modification description 01 January 31, 2023 Creation of the document Technical Documentation External Photos Version : 01 Page 2/8 Front View Technical Documentation External Photos Version : 01 Page 3/8 Rear View Technical Documentation External Photos Version : 01 Page 4/8 Right side View Technical Documentation External Photos Version : 01 Page 5/8 Left side View Technical Documentation External Photos Version : 01 Page 6/8 Top View Technical Documentation External Photos Version : 01 Page 7/8 Bottom View Technical Documentation External Photos Version : 01 Page 8/8 Accessories
Technical Documentation Internal Photos Publication History Version Date Modification description 03 July 2, 2024 Add view of BLE Antenna Technical Documentation Internal Photos Version : 03 Page 2/8 Device Open View (this picture is representative for the 10 models) Battery Electronic board (Rigid- flex circuit folded) External belt 54.3mm ,kljk Technical Documentation Internal Photos Version : 03 Page 3/8 Electronic Board with its technical frame (IS1 BLE and IS4 BLE) - Top side RF chip NORDIC nRF52832 Matching network ALLIANCE ASIC under the resin IS1 BLE: IS4 BLE: 55mm 78mm 55mm 78mm Technical Documentation Internal Photos Version : 03 Page 4/8 Electronic Board with its technical frame (IS1 BLE and IS4 BLE) – Bottom side Telemetry coil IS1 BLE: IS4 BLE: 55mm 78mm 78mm 55mm Footprints for the BLE feedthrough (BLE Antenna is connected to the BLE feedthrough, refer to page 8 for details) Technical Documentation Internal Photos Version : 03 Page 5/8 Electronic Board with its technical frame (IS4 BLE) – View of the thickness on 4 sides View of IS4 BLE with ruler nearby: (Note: same thickness for IS1 BLE) Technical Documentation Internal Photos Version : 03 Page 6/8 Electronic Board without the technical edge (example of IS4 BLE) - Top side RF chip NORDIC nRF52832 Matching network ALLIANCE ASIC under the resin IS4 BLE: Technical Documentation Internal Photos Version : 03 Page 7/8 Electronic Board without the technical edge (example of IS4 BLE) - Bottom side Telemetry coil IS4 BLE: Technical Documentation Internal Photos Version : 03 Page 8/8 Note: “NOT FOR HUMAN USE” is only marked on non-implanted devices used for V&V. For implantable devices, “NOT FOR HUMAN USE” will not be marked. View of BLE Antenna (example of IS1 BLE – VR 3240) BLE Antenna in the header (BLE Antenna is also named RF Antenna is the figure below). Note1: Header cannot be opened. Note2: Internal view of the titanium case is available in page2 of this document. BLE Feedthrough (also named RF feedthrough is the figure above)
LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS – FRANCE RF Exposure Considerations for FCC ID: YSGCRTD3744 Per FCC KDB 447498 D01 General RF Exposure Guidance v06 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz are based on source-based time-averaged maximum conducted output power of the RF channel requiring evaluation, adjusted for tune-up tolerance, and the minimum test separation distance required for the exposure conditions. The minimum test separation distance defined in 4.1 f) is determined by the smallest distance from the antenna and radiating structures or outer surface of the device, according to the host form factor, exposure conditions and platform requirements, to any part of the body or extremity of a user or bystander. Minimum test separation distance: 0.5 mm Step a) For 100 MHz to 6 GHz and test separation distances ≤ 50 mm The 1-g and 10-g SAR test exclusion thresholds are determined by the following: (max푝표푤푒푟표푓 푐ℎ푎푛푛푒푙 ( 푚푊 ) ) (min푡푒푠푡푠푒푝푎푟푎푡푖표푛 푑푖푠푡푎푛푐푒 ( 푚푚 ) ) × √ 푓 ( 퐺퐻푧 ) ≤3.0 푓표푟 1−푔 푆퐴푅 표푟 ≤7.5 푓표푟 10−푔 푒푥푡푟푒푚푖푡푦 푆퐴푅 Where: ▪ f(GHz) is the RF channel transmit frequency in GHz ▪ Power and distance are rounded to the nearest mW and mm before calculation31 ▪ The result is rounded to one decimal place for comparison ▪ The values 3.0 and 7.5 are referred to as numeric thresholds in step b) below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm, and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. (dBm) (mW) Min 2.402 2.8 1.91 5 0.59 3 7.5 Exempt from SAR Mid 2.400 2.46 1.76 5 0.55 3 7.5 Exempt from SAR Max 2.480 2.61 1.82 5 0.57 3 7.5 Exempt from SAR Limit for 10-g extremity SAR Verdict Maximum source-based time averaged conducted output power or EIRP (worst case) including tune-up tolerance Channel Frequency (GHz) Minimum separation distance (mm) Result of Eq. 1 Limit for 1-g SAR Conclusion: Therefore our device complies with FCC’s RF radiation exposure limits for general population without SAR evaluation.
Template : September 15 th , 2023 This document shall not be reproduced, except in full, without the written approval of the LCIE. This document contains results related only to the items tested. It does not imply the conformity of the whole production to the items tested. Unless otherwise specified or rule defined by the test method, the decision of conformity doesn’t take into account the uncertainty of measures. This document doesn’t anticipate any certification decision. The COFRAC accreditation attests the technical capability of the testing laboratory for the only tests covered by the accreditation. If some tests mentioned in this report are carried out outside the framework of COFRAC accreditation, they are indicated by the symbol . LCIE Laboratoire Central des Industries Electriques Une société Bureau Veritas Z.I Centr'alp 170, Rue de Chatagnon 38430 Moirans FRANCE Tél. + 33 4 76 07 36 36 [email protected] www.lcie.fr SAS au capital de 15 745 984€ / RCS Nanterre B 408 363 174 / N° TVA intracommunautaire FR01 408 363 174 / N°SIRET 408 363 174 00017 Accreditation N°1-1633 Scope available on www.cofrac.fr TEST REPORT N°: 21019537-796750-C(FILE#6633628) Version: 03 Subject Radio spectrum tests according to the standards: FCC CFR 47 Part 15.247 & ANSI C63.10 RSS-247 & RSS-Gen Issued to MICROPORT CRM 4 AVENUE REAUMUR 92140 - CLAMART FRANCE Apparatus under test Product Defibrillator Trade mark MICROPORT CRM Manufacturer MICROPORT CRM s.r.l Family range ENERGYA 4LV CRT-D 3744 Model under test ENERGYA 4LV CRT-D 3744 Serial number Q19JG037 , Q19D503E FCCID YSGCRTD3744 IC NC Conclusion See Test Program chapter Test date January 16, 2024 to February 01, 2024 Test location LCIE Grenoble FCC Test site FR0008 - 918017 (MOI) ISED Test site 6500A (MOI) Sample receipt date January 15, 2024 Composition of document 50 pages Document issued on July 01, 2024 Written by : Approved by : Akram HAKKARI Majid MOURZAGH Tests operator Technical manager TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 2/50 PUBLICATION HISTORY Version Date Author Modification 01 March 20, 2024 Akram HAKKARI Creation of the document 02 March 28, 2024 Akram HAKKARI Add informations on tables equipment list 03 July 01, 2024 Akram HAKKARI Correction limi PSD on page Each new edition of this test report replaces and cancels the previous edition. The control of the old editions of report is under responsibility of client. TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 3/50 SUMMARY 1. TEST PROGRAM ............................................................................................................................. 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) .............................. 5 3. 6DB BANDWIDTH .......................................................................................................................... 12 4. MAXIMUM CONDUCTED OUTPUT POWER ................................................................................. 16 5. POWER SPECTRAL DENSITY ...................................................................................................... 21 6. UNWANTED EMISSIONS IN NON-RESTRICTED FREQUENCY BANDS ..................................... 25 7. UNWANTED EMISSIONS IN RESTRICTED FREQUENCY BANDS .............................................. 30 8. UNCERTAINTIES CHART .............................................................................................................. 50 TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 4/50 1. TEST PROGRAM References ➢ 47 CFR Part 15.247 (2023) ➢ RSS 247 Issue 3 ➢ RSS Gen Issue 5 ➢ KDB 558074 D01 DTS Meas Guidance v05r02 ➢ KDB 662911 D01 Multiple Transmitter Output v02r01 ➢ ANSI C63.10 (2013) Radio requirement: Clause - Test Description Test result - Comments 6dB Bandwidth FCC & ISED PASS Maximum Conducted Output Power FCC & ISED PASS Power Spectral Density FCC & ISED PASS Unwanted Emissions in Non-Restricted Frequency Bands FCC & ISED PASS Unwanted Emissions in Restricted Frequency Bands FCC & ISED PASS Receiver Radiated Emissions ISED PASS(2) This table is a summary of test report, see conclusion of each clause of this test report for detail. (1) Limited program (2) Testing covered the receive mode, and receiver spurious emissions are considered to be the same as transmitter. PASS: EUT complies with standard’s requirement FAIL: EUT does not comply with standard’s requirement NA: Not Applicable NP: Test Not Performed TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 5/50 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): Model under test: ENERGYA 4LV CRT-D 3744 / Hybrid IS4 Serial Number: Q19JG037 , Q19D503E Dimensions: 5.5cm x 7.6 cm x 0.7cm (Length x Width x Height) Type: Table-Top Power supply: Name Type Rating Reference / Sn Comments Supply1 Battery 3.24 VDC - - NC: Not communicated by provider TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 6/50 Auxiliary equipment used during test: Type Reference Sn Comments Laptop DELL - - Inductive telemetry Head CPR3 CM1610029S - USB adapter to RS232 Sorin XA1311038E - NC: Not communicated by provider TEST REPORT N°21019537-796750-C(FILE#6633628) Version : 03 Page 7/50 Equipment information (declaration of provider): Bluetooth Low Energy: v4.2 Chipset / RF Module Nordic nRF52832 Frequency band: [2400 – 2483.5] MHz Spectrum Modulation: DSSS (Tested like it – international agreements) Number of Channel: 40 Spacing channel: 2MHz Channel bandwidth: 1MHz Antenna Type: Internal Antenna connector: Temporary for tests Antenna requirements §15.203 The transmitter uses an integral antenna and it permanently connected Transmit chains: 1 Receiver chains 1 CHANNEL PLAN Channel Frequency (MHz) Channel Frequency (MHz) Cmin: 0 2402 Cmid: 20 2442 1 2404 21 2444 2 2406 22 2446 3 2408 23 2448 4 2410 24 2450 5 2412 25 2452 6 2414 26 …
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Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 1/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. REVISION HISTORY Rev. Revised Section/Paragraph A Creation Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 2/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. TABLE OF CONTENT 1 Objective Objective of this document is to provide the gain and radiation pattern for the PLATINIUM BLE defibrillators to be commercialized in United States of America. 2 General description The gain and radiation pattern of each device is calculated by means of numerical computing. The implantable medical devices are designed to work into the human body so dielectric characteristics of human body are considering in the numerical model. Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 3/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. 2.1 Gain and Radiation pattern results 2.1.1 Devices with G440E Antenna The devices with G440E antenna and 3D Gain at fc (2440MHz) are: ENERGYA VR 3110 TALENTIA VR 3210 ENERGYA DR 3410 TALENTIA DR 3510 ENERGYA CRT-D 3711 Antenna G440E Antenna G440E Antenna G440E Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 4/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. Gain 3D max = -27.5 dBi Gain 3D max = -29.5 dBi Gain 3D max = -25 dBi Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 5/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. The 2D Radiation Pattern is: • For Min frequency Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 6/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. • Middle frequency Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 7/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. • Max frequency Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 8/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. 2.1.1 Devices with G730A and G731A Antennas The devices with G730A and G731A antennas and 3D Gain at fc (2440MHz) are: ENERGYA VR 3140 TALENTIA VR 3240 ENERGYA DR 3440 TALENTIA DR 3540 ENERGYA CRT-D 3741 Antenna G730A Antenna G731A Antenna G731A Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 9/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. Gain 3D max = -22.2 dBi Gain 3D max = -25.5 dBi Gain 3D max = -25.1 dBi Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 10/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. The 2D Radiation Pattern is: • Min frequency Figure 1 : Radiation pattern for IS1 Devices with G730A and G731A Antennas Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 11/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. • Middle frequency Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 12/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destroyed promptly thereafter. All hard copies are considered uncontrolled documents. • Max frequency Datasheet - Platinium BLE Antennas Document ref. Rev. FF00929G - DHF Page 13/17 Copyright MicroPort CRM. All rights reserved. May not be reproduced without permission. All hard copies should be checked against the current electronic version within Synapsis prior to use and destro…
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“ELECTRONIC DISTRIBUTION, CERTIFIED CONFORMING TO THE SIGNED AND APPROVED ORIGINAL”
LCIE SUD EST Laboratoire de Moirans Z.I. Centr’Alp 170, Rue de Chatagnon 38430 MOIRANS - FRANCE Page 1/1 CONDUCTED AND RADIATED MEASUREMENT PHOTO FCCID: YSGCRTD3744 1.1 Radiated emissions
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 1.91 mW |

Smart Spot
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
Implantable pacemaker with RF com
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Implantable pacemaker with RF com.
Equipment Class
DXX - Part 15 Low Power Communication Device Transmitter
Inductive programming head
Equipment Class
DCD - Part 15 Low Power Transmitter Below 1705 kHz
The Orchestra Plus Link
Equipment Class
TNB - Licensed Non-Broadcast Station Transmitter