YSGGB78Inductive programming head

SmartTouch USER MANUAL TABLE OF CONTENTS 1.WARNINGS AND PRECAUTIONS............................................................................5 2.WARRANTY CONDITIONS.......................................................................................7 3.THE PROGRAMMER SYSTEM.................................................................................8 General information....................................................................................................8 System overview........................................................................................................8 4.THE PROGRAMMER TABLET.................................................................................9 Components...............................................................................................................9 Charging the tablet...................................................................................................11 Setting up the system...............................................................................................12 Starting the programmer..........................................................................................13 Using the touch screen.............................................................................................13 Switching off the tablet............................................................................................13 5.THE PROGRAMMER SOFTWARE.........................................................................14 General information..................................................................................................14 Initial installation of the programmer software..........................................................14 Storing the patient data............................................................................................15 Upgrading the programmer software........................................................................15 6.THE DOCKING STATION........................................................................................16 Components.............................................................................................................16 General information..................................................................................................17 7.THE INDUCTIVE PROGRAMMING HEAD..............................................................18 Components.............................................................................................................18 General information..................................................................................................18 Using the inductive programming head....................................................................19 8.THE RADIO FREQUENCY (RF) LINK.....................................................................20 Components.............................................................................................................20 General information..................................................................................................20 Connecting the RF link to the programmer..............................................................21 9.THE ECG.................................................................................................................22 General Information..................................................................................................22 Pairing the wireless ECG device with the programmer............................................22 Starting the ECG display..........................................................................................22 10.THE PRINTER.........................................................................................................23 General information..................................................................................................23 Pairing a printer with the programmer......................................................................23 11.MAINTENANCE.......................................................................................................24 3.1. 3.2. 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 5.1. 5.2. 5.3. 5.4. 6.1. 6.2. 7.1. 7.2. 7.3. 8.1. 8.2. 8.3. 9.1. 9.2. 9.3. 10.1. 10.2. SmartTouch – UA10412A3 Cleaning...................................................................................................................24 Disinfection and sterilisation.....................................................................................24 System end-of-life....................................................................................................24 Spare parts...............................................................................................................24 12.GUIDANCE AND MANUFACTURER'S DECLARATION.......................................26 Radio equipment emission.......................................................................................26 Recommended separation distances according to the maximum output power of the communications equipment......................................................................................26 Cable length.............................................................................................................26 Electromagnetic emissions.......................................................................................27 Magnetic and Electromagnetic Immunity.................................................................27 Electromagnetic Immunity, Portable Radio Frequency Equipment..........................28 Raw materials...........................................................................................................29 13.TECHNICAL DATA..................................................................................................30 Conformity of the programmer.................................................................................30 US Federal Communicati…

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EIMicroP?[$" Federal Communications Commission 7435 Oakland Mills Road Columbia, M D 2LA46-1609 Bureau Veritas Consumer Products Services lnc One Distribution Center Circle, #1 Littleton, MA 01450 April 3rd, 2AZA Re: Confidentiality Reguest soRrN cRM s.A.s. To whom lt May concern: A MrcRoPoRr cRM CoMPANY This letter is to comply with 47 cFR 0.457(dX2) and 0.459 pertaining to 4, AVENUE REAUMUR 92140 CLAMART rnnnce ;::li*"Jll3',rr'.1Tfi1,i81'lffixx,:?11",T4l1i'ilS[g]?H*,"0, confidentia!: CONTACT r +33 (o)1 46 01 33 33 1. schematics 2. Block Diagram sHARE cAprrAL 104 82s 140 €. 3. Circuit/Technical Description RCs NANTERRE 309 786 481 4. Part liSt The material above contains technical data, which would customarily be guarded from competitors. Sincerely, MICROPORT CRM H EADQUARTER OFFICES 4, AVENUE REAUMUR 92T40 CLAMART F RANCE ,i {nm*tM Kathleen Vittum PRI NCIPAL REG UIATORY AFFAI RS SPECIALIST April 3rd, 2AZA crm.microport.com

EIMicroPH$- SORIN CRM S.A.S. A MICROPORT CRM COMPANY 4, AVENUE REAUMUR 92L4A CLAMART F RANC E CONTACT T +33 (0)1 46 01 33 33 SHARE CAPITAL 104 825 140 €. RCS NANTERRE 309 785 481 MICROPORT CRM H EADQUARTE R OFFICES 4, AVENUE REAUMUR 92L40 CLAMART F RANC E Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 2nq0-1609 March 20,2A2O To Whom lt 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 lD: YSGGBTS including the signing of all documents related to this matter. l Any and all acts carried out by LCIE Buredu Veritas on our behalf shall have the same effect as acts of our own. We also hereby certify that no party to tfiis 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, l Mltu j Kathleen Vittum Principal Regulatory Specialist MicroPort CRM Direct Tel. - 551-238-6A17 Ema i I : kathy.vittum @crm. m icroport.com crm.microport.com

Technical Documentation External Photos FCC ID YSGGB78 Publication History Version Date Modification description 01 March 6, 2020 Creation of the document Technical Documentation External Photos Version : 01 Page 2/4 Front View Technical Documentation External Photos Version : 01 Page 3/4 Rear View Accessories Technical Documentation External Photos Version : 01 Page 4/4

Technical Documentation FCC ID YSGGB78 Publication History Version Date Modification description 01 March 24, 2020 Creation of the document Technical Documentation Label Location Version : 01 Page 2/2 Label Location View

Technical Documentation GB78 CPR3H packaging label FCC ID YSGGB78 Publication History Version Date Modification description 01 March 6, 2020 Creation of the document Technical Documentation Label Version : 01 Page 2/2 GB78 CPR3H Device label Label View (1)

Technical Documentation Device open FCC ID YSGGB78 Publication History Version Date Modification description 01 March 6, 2020 Creation of the document Technical Documentation Internal Photos Version : 01 Page 2/5 Electronic card top Technical Documentation Internal Photos Version : 01 Page 3/5 Electronic card bottom Technical Documentation Internal Photos Version : 01 Page 4/5 Antennas Technical Documentation Internal Photos Version : 01 Page 5/5 All components Electronic Card Recto View (1)

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°: 165236-747020-B 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 CPR3H  Trade mark MICROPORT CRM  Manufacturer MICROPORT CRM s.r.l  Model under test CPR3H (inductive head)  Serial number 08031627017013 (inductive head)  FCC ID YSGGB78  IC 10270A-GB78 Conclusion See Test Program chapter Test date : January 16, 2020 to January 21, 2020 Test location Fontenay Aux Roses & Ecuelles Test Site 6230B-1 Sample receipt date January 16, 2020 Composition of document 27 pages Document issued on June 18, 2020 Written by : Approved by : Laurent DENEUX Arnaud FAYETTE Tests operator Technical manager TEST REPORT N° 165236-747020-B Version : 01 Page 2/27 PUBLICATION HISTORY Version Date Author Modification 01 June 18th, 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° 165236-747020-B Version : 01 Page 3/27 SUMMARY 1. TEST PROGRAM ............................................................................................................................... 4 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) ................................ 5 3. OCCUPIED BANDWIDTH ................................................................................................................... 9 4. AC POWER LINE CONDUCTED EMISSIONS.................................................................................. 12 5. TRANSMITTER RADIATED EMISSION............................................................................................ 20 6. UNCERTAINTIES CHART ................................................................................................................ 27 TEST REPORT N° 165236-747020-B Version : 01 Page 4/27 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° 165236-747020-B Version : 01 Page 5/27 2. EQUIPMENT UNDER TEST: CONFIGURATION (DECLARED BY PROVIDER) 2.1. HARDWARE IDENTIFICATION (EUT AND AUXILIARIES): Equipment under test (EUT): MICROPORT CRM CPR3H (inductive head) Serial Number: 08031627017013 (inductive head) Equipment Under Test TEST REPORT N° 165236-747020-B Version : 01 Page 6/27 Auxiliary equipment Power supply: During all the tests, EUT is supplied by V nom : 5VDC Voltage table used (for Power Line Conducted Emissions): Type Measurement performed:  AC  120VAC/60Hz  240VAC/50Hz  DC  +....VDC  -....VDC  Battery  +....VDC  -....VDC  USB (Laptop auxiliary)  120VAC/60Hz (Laptop auxiliary)  240VAC/50Hz(Laptop auxiliary) Inputs/outputs - Cable: Access Type Length used (m) Declared <3m Shielded Under test Comments 1 Power supply 2    HPU63A-107 2 Adapter USB/RS232 0.3    3 CPR3H 2.5    Auxiliary equipment used during test: Type Reference Sn Comments tablet V167 TPAC000742 - DOCKING STATION V174 GSV0000780 - IMPLANT SonR CRT-D 1811 J02DL02B - Power supply (Tablet) HPU63A-107 1915001217 - TEST REPORT N° 165236-747020-B Version : 01 Page 7/27 Equipment information: Frequency band: [9-315] kHz Number of Channel: 1 Antenna Type:  Integral  External  Dedicated Transmit chains: 1 Receiver chains 1 Type of equipment:  Stand-alone  Plug-in  Combined Equipment type:  Production model  Pre-production model Operating temperature range: Tmin:  -20°C  0°C  X°C Tnom: 20°C Tmax:  35°C  55°C  X°C Type of power source:  AC power supply  DC power supply  Battery Operating voltage range: Vnom:  120V/60Hz  5Vdc 2.2. 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  Alternative test mode() AC Power Line Conducted Emission  Test mode 1  Alternative test mode() Transmitter Radiated Emission  Test mode 1  Alternative test mode() 2.3. EQUIPMENT LABELLING TEST REPORT N° 165236-747020-B Version : 01 Page 8/27 2.4. EQUIPMENT MODIFICATION  None  Modification: TEST REPORT N° 165236-747020-B Version : 01 Page 9/27 3. OCCUPIED BANDWIDTH 3.1. TEST CONDITIONS Test performed by : Julien Palard Date of test : January 21, 2020 Ambient temperature : 24 °C Relative humidity : 34 % 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…

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Technical Documentation Test Set Up Photos FCC ID YSGGB78 Publication History Version Date Modification description 01 May 18, 2020 Creation of the document Technical Documentation Test Set Up Photos Version : 01 Page 2/2 Photograph for Unwanted Emission in restricted frequency bands