YSG1614Implantable pacemaker with RF com.

ALIZEA DR/ ALIZEA SR IMPLANT MANUAL Rate responsive dual-chamber pacemaker / Rate responsive single-chamber pacemaker Intended audience This manual is intended for use by professionals trained or experienced in device implant and/or follow-up procedures. blank DR SR ALIZEA Reminder Leads connection blank TABLE OF CONTENTS 1.GENERAL DESCRIPTION......................................................................................10 2.INTENDED USE AND TARGETED POPULATION.................................................11 Intended use.............................................................................................................11 Indications and targeted population.........................................................................11 3.CONTRAINDICATIONS AND ADVERSE EVENTS................................................13 General considerations............................................................................................13 Adverse events, risks and side effects.....................................................................13 4.WARNINGS.............................................................................................................16 Pacemaker dependent patients................................................................................16 Warnings to patients.................................................................................................16 Risks related to medical environment......................................................................16 Storage.....................................................................................................................18 Packaging.................................................................................................................18 5.CLINICAL STUDIES................................................................................................19 Methods....................................................................................................................19 Patients studied........................................................................................................19 Safety results............................................................................................................19 Effectiveness results................................................................................................19 6.PATIENT SELECTION AND TREATMENT.............................................................21 Specific patient populations......................................................................................21 7.PATIENT COUNSELING INFORMATION...............................................................22 8.DECLARATION OF CONFORMITY........................................................................23 9.PHYSICIAN GUIDELINES.......................................................................................24 Physician training.....................................................................................................24 Directions for use.....................................................................................................24 Maintaining device quality........................................................................................24 Implantation and device programming.....................................................................25 Lead evaluation and lead connection.......................................................................25 Programming and pacemaker operation..................................................................26 Rate increases.........................................................................................................26 Generator explant and disposal...............................................................................27 10.PATIENT INFORMATION........................................................................................28 11.HOW SUPPLIED......................................................................................................29 Sterility......................................................................................................................29 Warranty and replacement policy.............................................................................29 12.IMPLANT PROCEDURE..........................................................................................30 2.1. 2.2. 3.1. 3.2. 4.1. 4.2. 4.3. 4.4. 4.5. 5.1. 5.2. 5.3. 5.4. 6.1. 9.1. 9.2. 9.3. 9.4. 9.5. 9.6. 9.7. 9.8. 11.1. 11.2. ALIZEA – UA10414A7 Necessary equipment...............................................................................................30 Packaging contents..................................................................................................30 Optional equipment..................................................................................................30 Opening the package...............................................................................................30 Preparing the pocket................................................................................................31 Choosing the type of lead.........................................................................................32 Measurement of thresholds at implant.....................................................................32 Lead connections.....................................................................................................32 Implant considerations.............................................................................................33 13.PACEMAKER INTERROGATION AND UPGRADE...............................................34 14.SPECIAL MODES....................................................................................................35 Nominal mode (Safety mode)...................................................................................35 Standby mode..............................................…

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SORIN CRM S.A.S. A MICROPORT CRM COMPANY 4, AVENUE REAUMUR 92140 CLAMART FRANCE CONTACT T +33 (0)1 46 01 33 33 SHARE CAPITAL 104 825 140 €. RCS NANTERRE 309 786 481 MICROPORT CRM HEADQUARTER OFFICES 4, AVENUE RÉAUMUR 92140 CLAMART FRANCE crm.microport.com 4.20.2018 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 June 11 th , 2020 To Whom It May Concern: We, the undersigned, hereby authorize LCIE Bureau Veritas to act on our behalf in all matters relating to application for equipment authorization FCC ID: YSG1614 and YSG1311 including the signing of all documents related to this matter. Any and all acts carried out by LCIE Bureau Veritas on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to this application is subject to a denial of benefits including FCC benefits, pursuant to Section 5301 of Anti-drug Abuse Act of 1988, 21 U.S.C 862.. Sincerely, Kathy Vittum PRINCIPAL REGULATORY SPECIALIST MicroPort CRM Direct Tel. – 651-238-6017 Email – [email protected] June 11, 2020

SORIN CRM S.A.S. A MICROPORT CRM COMPANY 4, AVENUE REAUMUR 92140 CLAMART FRANCE CONTACT T +33 (0)1 46 01 33 33 SHARE CAPITAL 104 825 140 €. RCS NANTERRE 309 786 481 MICROPORT CRM HEADQUARTER OFFICES 4, AVENUE RÉAUMUR 92140 CLAMART FRANCE crm.microport.com 4.20.2018 June 10th of 2020 To Whom It May Concern: Re: Confidentiality Request This letter is to comply with 47 CFR 0.457(d)(2) and 0.459 pertaining to confidential material. SORIN CRM requests that the following documents regarding this submission for FCC ID YSG1614 and YSG1311 be kept confidential: 1. Schematics 2. Block Diagram 3. Part List 4. Operational Description The material above contains technical data, which would customarily be guarded from competitors. Sincerely, Kathleen VITTUM PRINCIPAL REGULATORY SPECIALIST JUNE 10 th of 2020 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Bureau Veritas Consumer Products Services Inc One Distribution Center Circle, #1 Littleton, MA 01460

Technical Documentation External Photos ALIZEA DR 1600 & CELEA DR 1400 Double chamber pacemakers Note : Physical difference between ALIZEA DR and CELEA DR models is only the front view FCC ID : YSG1614 Publication History Version Date Modification description 01 June 10, 2020 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

SORIN CRM S.A.S. A MICROPORT CRM COMPANY 4, AVENUE REAUMUR 92140 CLAMART FRANCE CONTACT T +33 (0)1 46 01 33 33 SHARE CAPITAL 104 825 140 €. RCS NANTERRE 309 786 481 MICROPORT CRM HEADQUARTER OFFICES 4, AVENUE RÉAUMUR 92140 CLAMART FRANCE crm.microport.com 4.20.2018 June 11, 2020 LABELING FOR FCC ID : YSG1614 and YSG1311 (DR & and SR families for models ALIZEA and CELEA) To Whom It May Concern : The equipment is implanted in the human body therefore the label with FCC ID is not feasible. Pursuant to sections 47 CFR 2.926 (e), we are proposing two following alternative methods: 1) The FCC ID and the statements required are in the User Manual (section 9) 2) The FCC ID appears on the package label which is affixed to the shipping box Sincerely, Kathleen Vittum PRINCIPAL REGULATORY SPECIALIST MicroPort CRM Direct Tel. – 651-238-6017 Email – [email protected] Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046-1609 Curtis-Straus LLC Certification Department – TCB/FCB 527 Great Road Littleton, MA 01460

Technical Documentation Packaging labels FCC ID YSG1614 Publication History Version Date Modification description 01 August 4, 2020 Creation of the document Technical Documentation Packaging labels Version : 01 Page 2/5 YSG1614: DR Family / ALIZEA DR Internal Package Label View Technical Documentation Packaging labels Version : 01 Page 3/5 YSG1614: DR Family / ALIZEA DR External Package Label View Technical Documentation Packaging labels Version : 01 Page 4/5 YSG1614: DR Family / CELEA DR Internal Package Label View Technical Documentation Packaging labels Version : 01 Page 5/5 YSG1614: DR Family / CELEA DR External Package Label View

Technical Documentation Internal Photos FCC ID : YSG1614 Internal pictures are identical for the both dual and single chambers families including the following models: ALIZEA DR 1600, CELEA DR 1400 Publication History Version Date Modification description 01 June 10, 2020 Creation of the document Technical Documentation Internal Photos Version : 01 Page 2/4 Device Open View Technical Documentation Internal Photos Version : 01 Page 3/4 Electronic Card Recto View (1) RF chip NORDIC nRF52832 Matching network Telemetry coil Technical Documentation Internal Photos Version : 01 Page 4/4 Electronic Card Recto View (1) ALLIANCE ASIC under the resin

RF Exposure Considerations for FCC ID: YSG1614 Per FCC KDB 447498 D01 General RF Exposure Guidance v05 The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by (Eq.1) below: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] * [√f(GHz)] If result of Eq.1 is less than or equal to the exemption limits below, then corresponding SAR test is not required. SAR Test Configuration Exemption limit 1-g SAR Result of Eq.1 ≤ 3.0 10-g extremity SAR Result of Eq.1 ≤ 7.5 where; f(GHz) is the RF channel transmit frequency in GHz. Power and distance are rounded to the nearest mW and mm before calculation. The result is rounded to one decimal place for comparison. 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. For our device, the parameters for consideration are as follows: Channel Frequency (GHz) Maximum source- based time averaged conducted output power including tune-up tolerance (mW) Minimum separation distance (mm) Result of Eq. 1 Limit for 1-g SAR Limit for 10-g extremity SAR Verdict 0 2.402 2,58 mW 5mm 0,8 3.0 7.5 Exempt from SAR 20 2.442 2,60 mW 5mm 0,8 3.0 7.5 39 2.480 3,15 mW 5mm 1 3.0 7.5 Conclusion: Therefore our device complies with FCC’s RF radiation exposure limits for general population without SAR evaluation.

RFID 125kHz Template: Release October 14 th , 2019 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. TEST REPORT N°: 164827-746022-E Version : 01 Subject Radio spectrum matters tests according to standards: 47 CFR Part 15.209 & Part 15.207 & RSS-Gen Issue 5 Issued to MICROPORT CRM Parc d’Affaires NOVEOS - 4 avenue Réaumur 92143 Clamart FRANCE Apparatus under test  Product Pacemaker  Trade mark MICROPORT CRM  Maufacturer MICROPORT CRM s.r.l  Model under test BOREA DR 1500  Serial number N38GF05A  FCC ID YSG1614 & YSG1311  IC - Conclusion See Test Program chapter Test date : December 4, 2019 to December 5, 2019 Test location Ecuelles Test Site 6230B-1 Sample receipt date December 4, 2019 Composition of document 18 pages Document issued on March 26, 2020 Written by : Approved by : Laurent DENEUX Arnaud FAYETTE Tests operator Technical manager TEST REPORT N° 164827-746022-E Version : 01 Page 2/18 PUBLICATION HISTORY Version Date Author Modification 01 March 26th, 2020 Laurent DENEUX Creation of the document 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° 164827-746022-E Version : 01 Page 3/18 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) ................................ 5 3. OCCUPIED BANDWIDTH ................................................................................................................... 9 4. TRANSMITTER RADIATED EMISSION............................................................................................ 12 5. UNCERTAINTIES CHART ................................................................................................................ 18 TEST REPORT N° 164827-746022-E Version : 01 Page 4/18 1. TEST PROGRAM References  47 CFR Part 15.209 & 15.207  RSS Gen Issue 5  ANSI C63.10-2013 Radio requirement: Clause (47CFR Part 15.209 & 15.207 & RSS-Gen Issue 5) Test Description Test result - Comments Occupied Bandwidth   PASS  FAIL  NA  NP(1) AC Power Line Conducted Emission   PASS  FAIL  NA(2)  NP(1) Transmitter Radiated Emission   PASS  FAIL  NA  NP(1) Receiver Radiated Emissions   PASS (3)  FAIL  NA  NP(1) This table is a summary of test report, see conclusion of each clause of this test report for detail. (1): Limited program (2): EUT not directly or indirectly connected to the AC Power Public Network (3)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° 164827-746022-E Version : 01 Page 5/18 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. INFORMATIONS -Tests are performed on the product BOREA DR 1500, SN: N38GF05A. See Table below for difference between products. BOREA DR 1500 ALIZEA DR 1600 CELEA DR 1400 Tested product Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. 2.2. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): MICROPORT CRM BOREA DR 1500 Serial Number: N38GF05A Equipment Under Test TEST REPORT N° 164827-746022-E Version : 01 Page 6/18 Auxiliary equipment TEST REPORT N° 164827-746022-E Version : 01 Page 7/18 Inputs/outputs - Cable: Access Type Length used (m) Declared <3m Shielded Under test Comments - - -    Auxiliary equipment used during test: Type Reference Sn Comments Inductive telemetry head CPR3 - SORIN M10090 - A CPR3 - Ampli part Antenna - - MICROPORT CRM Laptop 51181 - DELL Equipment information: Frequency band: [9-315] kHz Antenna Type:  Integral  External  Dedicated Transmit chains: 1 Receiver chains 1 Equipment type:  Production model  Pre-production model Operating temperature range: Tmin:  -20°C  0°C  25°C Tnom: 27°C Tmax:  35°C  55°C  45°C Type of power source:  AC power supply  DC power supply  Battery Operating voltage range: Vnom:  120V/60Hz  3.2Vdc Hardware information Software (if applicable): V. : V2.5.1 Build 15 TEST REPORT N° 164827-746022-E Version : 01 Page 8/18 2.3. RUNNING MODE Test mode Description of test mode Test mode 1 Permanent emission with modulation on a fixed channel in the data rate that produced the highest power Test Running mode Occupied Bandwidth  Test mode 1 (1)  Alternative test mode() Transmitter Radiated Emission  Test mode 1 (1)  Alternative test mode() 2.4. EQUIPMENT LABELLING 2.5. EQUIPMENT MODIFICATION  None  Modification: TEST REPORT N° 164827-746022-E Version : 01 Page 9/18 3. OCCUPIED BANDWIDTH 3.1. TEST CONDITIONS Test performed by : Armand MAHOUNGOU Date of test : January 10, 2020 Ambient temperature : 27°C Relative humidity : 47% 3.2. TEST SETUP - The Equipment Under Test is installed:  On a table  In an anechoic chamber - Measurement is performed with a spectrum analyzer in:  Conducted Method  Radiated Method - Test Procedure:  RSS-Gen Issue 5 § 6.7 Test set up of Occupied Bandwidth Spectrum analyser or EMI receiver E.U.T Climatic Chamber TEST REPORT N° 1648…

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Bluetooth Low Energy Template: Release October 11 th , 2019 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. TEST REPORT N°: 164827-746022-A Version : 01 Subject Radio spectrum matters tests according to standards: 47 CFR Part 15.247 & RSS-247 Issue 2 & RSS-Gen Issue 5 Issued to MICROPORT CRM Parc d’Affaires NOVEOS - 4 avenue Réaumur 92143 Clamart FRANCE Apparatus under test  Product Pacemaker  Trade mark MICROPORT CRM  Manufacturer MICROPORT CRM s.r.l  Model under test BOREA DR 1500  Serial number N38GF05A for radiated test N38G2062 for conducted test  FCC ID YSG1614  IC - Conclusion See Test Program chapter Test date December 9, 2019 to December 20, 2019 Test location Fontenay Aux Roses & Ecuelles Test Site 6230B-1 Sample receipt date December 4, 2019 Composition of document 43 pages Document issued on March 26, 2020 Written by : Approved by : Armand MAHOUNGOU Arnaud FAYETTE Tests operator Technical manager TEST REPORT N° 164827-746022-A Version : 01 Page 2/43 PUBLICATION HISTORY Version Date Author Modification 01 March 26, 2020 Armand MAHOUNGOU Creation of the document 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° 164827-746022-A Version : 01 Page 3/43 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) ................................ 5 3. OCCUPIED BANDWIDTH ................................................................................................................... 9 4. 6DB EMISSION BANDWIDTH .......................................................................................................... 12 5. DUTY CYCLE ................................................................................................................................... 15 6. MAXIMUM CONDUCTED OUTPUT POWER ................................................................................... 18 7. POWER SPECTRAL DENSITY ........................................................................................................ 21 8. UNWANTED EMISSIONS INTO NON-RESTRICTED FREQUENCY BANDS AT THE BAND EDGE 24 9. UNWANTED EMISSIONS INTO NON-RESTRICTED FREQUENCY BANDS ................................... 27 10. UNWANTED EMISSIONS IN RESTRICTED FREQUENCY BANDS ................................................ 31 11. UNCERTAINTIES CHART ................................................................................................................ 43 TEST REPORT N° 164827-746022-A Version : 01 Page 4/43 1. TEST PROGRAM References  47 CFR Part 15.247  RSS 247 Issue 2  RSS Gen Issue 5  KDB 558074 D01 DTS Meas Guidance v05r02  ANSI C63.10-2013 Radio requirement: Clause (47CFR Part 15.247 & RSS-247 Issue 2 & RSS-Gen Issue 5) Test Description Test result - Comments Occupied Bandwidth  PASS  FAIL  NA  NP(1) 6dB Bandwidth  PASS  FAIL  NA()  NP(1) Duty Cycle   PASS  FAIL  NA  NP(1) Maximum Conducted Output Power  PASS  FAIL  NA  NP(1) Power Spectral Density   PASS  FAIL  NA  NP(1) Conducted Spurious Emission at the Band Edge   PASS  FAIL  NA()  NP(1) Unwanted Emissions into Non-Restricted Frequency Bands   PASS  FAIL  NA()  NP(1) AC Power Line Conducted Emission   PASS  FAIL  NA(2)  NP(1) Unwanted Emissions into Restricted Frequency Bands   PASS  FAIL  NA  NP(1) Receiver Radiated emissions   PASS  FAIL  NA  NP(1) This table is a summary of test report, see conclusion of each clause of this test report for detail. (1): Limited program (2): EUT not directly or indirectly connected to the AC Power Public Network 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° 164827-746022-A Version : 01 Page 5/43 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. INFORMATIONS -Tests are performed on the product BOREA DR 1500, SN: N38GF05A. See Table below for difference between products. BOREA DR 1500 ALIZEA DR 1600 CELEA DR 1400 Tested product Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. 2.2. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): BOREA DR 1500 Serial Number: N38GF05A for radiated test & N38G2062 for conducted test Equipment Under Test TEST REPORT N° 164827-746022-A Version : 01 Page 6/43 Power supply: During all the tests, EUT is supplied by V nom : 3.20VDC For measurement with different voltage, it will be presented in test method. Auxiliary equipment used during test: Type Reference Sn Comments Laptop computer - - - CPR3 - CN1709012S - Dongle - XA1311038E - Equipment information: Bluetooth LE Type:  BLE  v4.0  v4.1  v4.2 Frequency band: [2400 – 2483.5] MHz Number of Channel: 40 Spacing channel: 2MHz Channel bandwidth: 1MHz Antenna Type:  Integral  External  Dedicated Antenna connector:  Yes  No  Temporary for test Transmit chains: 1 Single antenna Receiver chains 1 Type of equipment:  Stand-alone  Plug-in  Combined Duty cycle:  Continuous duty  Intermittent duty  100% duty Equipmen…

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902MHz-928MHz Template: Release October 14 th , 2019 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. TEST REPORT N°: 164827-746022-C Version : 01 Subject Radio spectrum matters tests according to standards: 47 CFR Part 15.249 & RSS-210 Issue 9 & RSS-Gen Issue 5 Issued to MICROPORT CRM Parc d’Affaires NOVEOS - 4 avenue Réaumur 92143 Clamart FRANCE Apparatus under test  Product Pacemaker  Trade mark MICROPORT CRM  Manufacturer MICROPORT CRM s.r.l  Model under test BOREA DR 1500  Serial number N38D205A for radiated test N38G2062 for conducted test  FCC ID YSG1614  IC - Conclusion See Test Program chapter Test date December 9, 2019 to December 20, 2019 Test location Fontenay Aux Roses & Ecuelles Test Site 6230B-1 Sample receipt date December 4, 2019 Composition of document 24 pages Document issued on March 26, 2020 Written by : Approved by : Armand MAHOUNGOU Arnaud FAYETTE Tests operator Technical manager TEST REPORT N° 164827-746022-C Version : 01 Page 2/24 PUBLICATION HISTORY Version Date Author Modification 01 March 26, 2020 Armand MAHOUNGOU Creation of the document 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° 164827-746022-C Version : 01 Page 3/24 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) ................................ 5 3. OCCUPIED BANDWIDTH ................................................................................................................... 8 4. FIELD STRENGHT OF EMISSION & FIELD STRENGHT OF HARMONICS .................................... 11 5. UNWANTED EMISSIONS IN RESTRICTED FREQUENCY BANDS ................................................ 14 6. UNCERTAINTIES CHART ................................................................................................................ 24 TEST REPORT N° 164827-746022-C Version : 01 Page 4/24 1. TEST PROGRAM References  47 CFR Part 15.249  RSS 210 Issue 9  RSS Gen Issue 5  ANSI C63.10-2013 Radio requirement: Clause (47CFR Part 15.249 & RSS-249 Issue 2 & RSS-Gen Issue 5) Test Description Test result - Comments Occupied Bandwidth   PASS  FAIL  NA  NP(1) Field strength of fundamental & Field strength of harmonics   PASS  FAIL  NA()  NP(1) AC Power Line Conducted Emission   PASS  FAIL  NA(2)  NP(1) Unwanted Emissions into Restricted Frequency Bands   PASS  FAIL  NA  NP(1) Receiver Radiated emissions   PASS  FAIL  NA  NP(1) This table is a summary of test report, see conclusion of each clause of this test report for detail. (1): Limited program (2): EUT not directly or indirectly connected to the AC Power Public Network 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° 164827-746022-C Version : 01 Page 5/24 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. INFORMATIONS -Tests are performed on the product BOREA DR 1500, SN: N38D205A. See Table below for difference between products. BOREA DR 1500 ALIZEA DR 1600 CELEA DR 1400 Tested product Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. Embedded Software is slightly different from BOREA. But these differences do not impact the radio functionality of the implant. The hardware and mechanical structure are strictly the same than BOREA. 2.2. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): BOREA DR 1500 Serial Number: N38D205A for radiated test & N38G2062 for conducted test Equipment Under Test TEST REPORT N° 164827-746022-C Version : 01 Page 6/24 Auxiliary equipment used during test: Type Reference Sn Comments Laptop computer - - - CPR3 - CN1709012S - Dongle - XA1311038E - Equipment information: Frequency band: [2400 – 2483.5] MHz Number of Channel: 1 Spacing channel: - MHz Channel bandwidth: 0.3 MHz Antenna Type:  Integral  External  Dedicated Antenna connector:  Yes  No  Temporary for test Transmit chains:  1  2 Receiver chains  1  2 Type of equipment:  Stand-alone  Plug-in  Combined Ad-Hoc mode:  Yes  No Duty cycle:  Continuous duty  Intermittent duty  100% duty Equipment type:  Production model  Pre-production model Operating temperature range: Tmin:  -20°C  0°C  25°C Tnom: 27°C Tmax:  35°C  55°C  45°C Type of power source:  AC power supply  DC power supply  Battery Operating voltage range: Vnom:  120V/60Hz  3,2 Vdc Antenna Characteristic Antenna assembly Gain (dBi) Fre…

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