QRI-QCONNECTData Gateway for Electrophysiology Lab

Qubic Connect Device for data transmission from the cardiac catheter laboratory Technical Manual BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369 Tel (800) 547–0394 (24-hour) Fax (503) 635–9936 [email protected] BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] www.biotronik.com 22-D-xx Revision: A (2022-11-22) © BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner. 476463--A Table of Contents 1 Table of Contents 1 About this Technical Manual .................................................... 2 Objective ........................................................................................ 2 Conventions .................................................................................. 2 2 Device Description ................................................................... 4 Intended Purpose ......................................................................... 4 Intended Conditions of Use .......................................................... 4 3 Safety ....................................................................................... 5 Conditions for Operation .............................................................. 5 Maintenance, Care, and Disposal ................................................ 6 4 Device Handling ....................................................................... 8 Device Overview ............................................................................ 8 Setting up the Device .................................................................. 15 Connections and Cables ............................................................. 17 Connecting the Device ................................................................ 19 Activating Qubic Connect Service .............................................. 19 Configuring Connection to the Internet with WIFI and LAN ..... 21 Connecting the AcQMap System ................................................ 23 5 Troubleshooting ..................................................................... 24 6 Appendix ................................................................................. 27 Technical Data ............................................................................ 27 Accessories ................................................................................. 31 Country-Related Information ..................................................... 32 Legend for the Label .................................................................. 34 Index ....................................................................................... 36 476463--A About this Technical Manual 2 1 About this Technical Manual Objective This technical manual provides information on how to use Qubic Connect. Among others, the following topics are explained: • Device startup • Device handling • Disposal • Transportation Technical manuals are either included in hard copy form in the storage package or available in digital form on the internet: https://manuals.biotronik.com. 1. Consult the technical manual. 2. Keep the technical manual for future reference. Conventions Identification of Safety Warnings The following symbol draws attention to potential safety risks: Follow all safety warnings indicated by this symbol to avoid possible serious or fatal injury or damage to the system. Safety warnings are also indicated by a signal word. Signal wordMeaning AttentionNon-compliance leads to a potentially dangerous situation that can cause minor injuries and/or material damage. About this Technical Manual 3 Typographical Conventions The following typographical conventions are used in this technical manual: Instructions The individual steps of an instruction are numbered. Prerequisites, intermediate results, and results may be specified. Prerequisite This is a prerequisite. 1. Step 2. Step Intermediate result 3. Step Result This is the result. ElementsDescription and appearance Cross refer- ences Cross references are indicated using "see" or "see also". HighlightsText that needs to be highlighted is shown in bold. NotesUseful information is indicated using the word Note. Figures Figures that show the product or the user interface are used for illustration. The details shown in the figure may differ from that of the delivered product or your software version. Gender If personal designations are used only in the male or female form for reasons of better readability, this expressly includes all other gender identities. Device Description 4 2 Device Description Intended Purpose The Qubic Connect is designed for downloading data from medical products or devices used in an EP lab and uploading the data to the BIOTRONIK Cloud Services. The Qubic Connect device is designed for stationary and mobile usage. Intended Conditions of Use Application environment The Qubic Connect may be used anywhere within the specified temperature, pressure, and humidity ranges (see Operating Conditions). The Qubic Connect is typically placed in the control room of an EP lab on the office desk, for example. Safety 5 3 Safety Conditions for Operation Transport and Storage If the package is damaged, please contact BIOTRONIK immediately. Do not put the device into operation. The ambient conditions for shipping and storage are: Temperature+ 0°C (32°F) ... + 50°C (122°F) Relative humidity30% ... 75%, no condensation Atmospheric pressure700 ... 1060 hPa Operating Conditions Attention After transporting the equipment from a cold location to a warm location, condensation may form, particularly on metal parts of the device, and damage the electronics. • After transport, wait approximately 2 h until the device has reached room temperature and the condensation has dried up before using the system. The a…

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BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg To whom it may concern: We, the undersigned, hereby authorize Eurofins Product Service GmbH to act on our behalf in all matters relating to applications for equipment authorization FCC ID: QRI-QCONNECT including the signing of all documents related to these matters. Any and all acts carried out by Eurofins Product Service GmbH on our behalf shall have the same effect as acts of our own. By signing this form, we agree to Eurofins’ current valid General Terms and Conditions (AGB),Testing and Certification Regulations (PZO) which can be viewed on following website www.eurofins.de/ee or retrieved on request. 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 the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Sincerely, Mark Briesemeister Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1282 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, 20-Oct-22 Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Request for Permanent Confidentiality Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-QCONNECT FCC Part 15 Certification Gentlemen, In accordance with CFR 47 § 0.457 and CFR 47 § 0.459 BIOTRONIK SE & Co. KG hereby requests confidentiality of following attachments: (1) schematic diagrams, (2) detailed block diagrams, (3) detailed operational descriptions, (4) parts lists. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Mark Briesemeister Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1282 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, 20 October 2022 Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Request for Short Term Confidentiality, intended to allow importation / distribution of authorized equipment while maintaining confidentiality before product launch Company name: BIOTRONIK SE & Co. KG FCC ID: QRI-QCONNECT FCC Part 15 Certification Gentlemen, In accordance with 0.457 and 0.459 of CFR 47, BIOTRONIK SE & Co. KG hereby requests for ‘Short Term Confidentiality of all • External Photos, • Test Setup Photos, • Internal Photos, • User manual / Instruction For Use attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which BIOTRONIK SE & Co. KG considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, BIOTRONIK SE & Co. KG considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, Mark Briesemeister Regulatory Affairs Senior Manager BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-1282 Fax +49 (0) 30 68905-1921 [email protected] www.biotronik.com Berlin, 20 October 2022 Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Dr. Thomas Kraft Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Declaration concerning Antenna Specification It is hereby declared that the product Model No.: Qubic Connect FCC ID: QRI-QCONNECT fulfills the requirement in FCC test relating to the antenna type. The device specified above confirms to the FCC recommendations for external antenna type described below: Model No. of antenna: DELOCK 88977 Type of antenna: external blade antenna Gain of the antenna: FDD2, FDD4, FDD25, FDD66: 1.5 dBi FDD12, FDD13, FDD17, FDD29: 1.5 dBi FDD5, FDD26: 0 dBi FDD7: 4 dBi Frequency range: 1710 MHz - 2170 MHz, 2500 MHz - 2700 MHz, 698 MHz - 791 MHz, 824 MHz - 960 MHz The mounting of the antenna is fixed to the radio module and no other antenna should be used. Sincerely Dr.-Ing. Christian Weber BIOTRONIK SE & Co. KG Tel +49 (0) 30 68905-4482 [email protected] www.biotronik.com Berlin, 22 November 2022 Federal Communications Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin Steuer-Nr.: 30/005/75408 USt.-Ident Nr.: DE136651322 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6844060 [email protected] www.biotronik.com Geschäftsführende Direktoren: Dr. Alexander Uhl (Vorsitzender) Stephan Schulz-Gohritz Kommanditgesellschaft: HRA 6501 B, AG Berlin-Charlottenburg Komplementärin: BIOTRONIK MT SE HRB 118866 B, AG Berlin-Charlottenburg Statement of re-use of original test results of approved radio modules according to KDB 996369 D02 Module Q and A v01 Q1(a) Reference of new FCC ID application: Applicant: BIOTRONIK SE & Co. KG FCC ID: QRI-QCONNECT We, the undersigned, hereby declare that our radio device hosts the following approved radio module(s) Grantee: Intel Corporation Type of Module: AX210NGW FCC ID: PD9AX210NG Report Reference 200611-03.TR01, Rev 01 ; 200611-03.TR02 Rev 03 200611-03.TR03, Rev. 01 ; 200611-03.TR04 Rev 01 200611-03.TR06, rev 01 Grantee: Telit Communications S.p.A. Type of Module: LM940 FCC ID: RI7LM940 Report Reference FW750208 Rev 01 ; FG750208B Rev 01 The module(s) is/are installed according to the installation instructions of the module manufacturer(s) without modification. The original module test report(s) accurately represent all conducted measured test results under the new conditions. All radiated measurements according to the applicable radio standard(s), the RF-exposure and simultaneous transmission evaluation are performed and reported for the entire host. Sincerely, BIOTRONIK SE & Co. KG Dirk König Regulatory Affairs Senior Manager Tel +49 (0) 30 68905-1291 Fax +49 (0) 30 68905-961291 [email protected] www.biotronik.com Berlin, 5 December 2022 Federal Communication Commission Authorization and Evaluation Division Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 BIOTRONIK SE & Co. KG · Postfach 470255 · 12311 Berlin

FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512

Qubic Connect – type label Figure 1: Qubic Connect type label

Qubic Connect – Type Label Sample and Location Figure 1: Bottom view of Qubic Connect Figure 2: Type label placement on Qubic Connect Pos. 002: Figure 3: Qubic Connect type label

FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512 FCC ID: QRI-QCONNECT IC: 4708A-QCONNECT HVIN: Qubic Connect G0M‐2206‐1512

Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 27 RF-EXPOSURE REPORT FCC 47 CFR Part 2.1091 ISED RSS-102 Maximum permissible exposure Report Reference No G0M-2206-1512-TFC091MP-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Test Firm Designation Number: DE0008 ISED Testing Laboratory site: 3470A-2 Applicant BIOTRONIK SE & Co. KG Address Woermannkehre 1 12359 Berlin GERMANY Test Specification According to FCC/ISED rules Standard FCC 47 CFR 2.1091 ISED RSS-102 Non-Standard Test Method None Equipment under Test (EUT): Product Description Data Gateway for Electrophysiology Lab Model(s) Qubic Connect Additional Model(s) None Brand Name(s) BIOTRONIK Hardware Version(s) A.A Software Version(s) Wi-Fi Driver Version: 22.70.0.6, LTE Modem Firmware: 24.01.514 FCC ID QRI-QCONNECT IC 4708A-QCONNECT Test Result PASSED Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 27 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2022-11-30 Initial Release Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 27 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EIRP Equivalent Isotropic Radiated Power EUT Equipment Under Test MPE Maximum Permissible Exposure Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 27 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Reference Documents ................................................................................................................................... 7 1.2 Power density radiation sources.................................................................................................................... 8 1.3 Field strength radiation sources .................................................................................................................... 8 1.4 Concurrent Sources ...................................................................................................................................... 8 2 Result Summary ................................................................................................................................. 9 3 RF-Exposure classification ............................................................................................................ 11 4 RF-Exposure limits .......................................................................................................................... 12 5 RF-Exposure Evaluation ................................................................................................................. 13 6 Single Source Evaluation Results - FCC ...................................................................................... 14 7 Single Source Evaluation Results - ISED ..................................................................................... 21 Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 27 1 Equipment (Test Item) Under Test Description Data Gateway for Electrophysiology Lab Model Qubic Connect Additional Model(s) None Brand Name(s) BIOTRONIK Serial Number(s) (44) 00298859 Hardware Version(s) A.A Software Version(s) Wi-Fi Driver Version: 22.70.0.6, LTE Modem Firmware: 24.01.514 PMN Qubic Connect HVIN Qubic Connect FVIN n/a HMN n/a FCC ID QRI-QCONNECT IC 4708A-QCONNECT Equipment type End Product Environment General public Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 27 1.1 Reference Documents Document Type Document No. Issued by Date Radio Test Report FCC CFR Title 47 Part 15 C RSS-247 issue 2, RSS-Gen issue 5 A1 200611-03.TR04 Intel Corporation S.A.S – WRF Lab 2020-10-14 Radio Test Report FCC CFR Title 47 Part 15 E (U-NII-1 & 2A) 200611-03.TR01 Intel Corporation S.A.S – WRF Lab 2020-10-14 Radio Test Report FCC CFR Title 47 Part 15 E RSS-247 issue 2, RSS-Gen issue 5 A1 (U-NII-2C) 200611-03.TR02 Intel Corporation S.A.S – WRF Lab 2020-10-26 Radio Test Report FCC CFR Title 47 Part 15 E RSS-247 issue 2, RSS-Gen issue 5 - A1 (U-NII-3) 200611-03.TR03 Intel Corporation S.A.S – WRF Lab 2020-10-14 Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 27 1.2 Power density radiation sources Power density radiation Mode Operating Frequency [MHz] Maximum conducted power [dBm] Maximum radiated power [dBm EIRP] Maximum duty cycle [%] Maximum antenna gain [dBi] Maximum antenna diameter [cm] IEEE 802.11 (2.4 GHz) 2442 28.99 31.49 100 2.5 N/A IEEE 802.11 (U-NII-1) 5230 22.99 27.59 100 4.6 N/A IEEE 802.11 (U-NII-2A) 5280 22.18 26.78 100 4.6 N/A IEEE 802.11 (U-NII-2C) 5590 23.88 28.48 100 4.6 N/A IEEE 802.11 (U-NII-3) 5755 24.22 28.82 100 4.6 N/A LTE FDD2 1880.0 25.7* 27.2 100 1.5 N/A LTE FDD4 1732.5 25.7* 27.2 100 1.5 N/A LTE FDD5 836.5 25.7* 25.7 100 0 N/A LTE FDD12 707.5 25.7* 27.2 100 1.5 N/A LTE FDD17 710.0 25.7* 27.2 100 1.5 N/A LTE FDD25 1882.5 25.7* 27.2 100 1.5 N/A LTE FDD26 831.5 25.7* 25.7 100 0 N/A LTE FDD66 1745 25.7* 27.2 100 1.5 N/A Comment: * Maximum power permitted by specific radio technology standard. 1.3 Field strength radiation sources None 1.4 Concurrent Sources No concurrent radiation sources Test Report No.: G0M-2206-1512-TFC091MP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 27 2 Result Summary FCC MPE Evaluation - Single radiation sources Product Standard Refer…

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Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 51 RADIO REPORT FCC 47 CFR Part 22H, FCC 47 CFR Part 24E, FCC 47 CFR Part 27, FCC 47 CFR Part 90 Report Reference No G0M-2206-1512-TFCMOCORSE-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation DAkkS - Registration number : D-PL-12092-01-04 (FCC) FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant BIOTRONIK SE & Co. KG Address Woermannkehre 1 12359 Berlin GERMANY Test Specification 47 CFR Part 22H 47 CFR Part 24E 47 CFR Part 27L/H 47 CFR Part 90S Non-Standard Test Method None Equipment under Test (EUT): Product Description Data Gateway for Electrophysiology Lab Model(s) Qubic Connect Additional Model(s) None Brand Name(s) BIOTRONIK Hardware Version(s) A.A Software Version(s) LTE Modem Firmware: 24.01.514 FCC ID QRI-QCONNECT Test Result PASSED Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 51 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2023-01-09 Initial Release Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 51 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description EUT Equipment Under Test FCC Federal Communications Commission ISED Innovation, Science and Economic Development Canada RBW Resolution bandwidth RMS Root mean square VBW Video bandwidth V NOM Nominal supply voltage Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 51 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Photos – Equipment External ........................................................................................................................ 7 1.2 Photos – Equipment Internal ....................................................................................................................... 11 1.3 Support Equipment ...................................................................................................................................... 15 1.4 Test Modes ................................................................................................................................................. 16 1.5 Sample emission level calculation ............................................................................................................... 19 2 Result Summary ............................................................................................................................... 21 3 Test Conditions and Results .......................................................................................................... 22 3.1 Test Conditions and Results - Radiated power ........................................................................................... 22 3.2 Test Conditions and Results - Transmitter radiated emissions ................................................................... 25 ANNEX A Transmitter radiated emissions ........................................................................................................ 31 Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 51 1 Equipment (Test Item) Under Test Description Data Gateway for Electrophysiology Lab Model Qubic Connect Additional Model(s) None Brand Name(s) BIOTRONIK Serial Number(s) 00298859 Test Sample Id(s) 40181 Hardware Version(s) A.A Software Version(s) LTE Modem Firmware: 24.01.514 FCC ID QRI-QCONNECT Equipment type End Product Radio type Transceiver Radio technologies LTE LTE frequency bands LTE FDD 2 : UL = 1850 - 1910 MHz, DL = 1930 - 1990 MHz LTE FDD 4 : UL = 1710 - 1755 MHz, DL = 2110 - 2155 MHz LTE FDD 5 : UL = 824 - 849 MHz, DL = 869 - 894 MHz LTE FDD12 : UL = 699 - 716 MHz, DL = 729 - 746 MHz LTE FDD17 : UL = 704 - 716 MHz, DL = 734 - 746 MHz LTE FDD25 : UL = 1850 - 1915 MHz, DL = 1930 - 1995 MHz LTE FDD26 : UL = 814 - 849 MHz, DL = 859 - 894 MHz LTE FDD29 : UL = N/A, DL = 717 - 728 MHz LTE FDD66 : UL = 1710 - 1780 MHz, DL = 2110 - 2200 MHz LTE Modulations QPSK, 16-QAM, 64-QAM Number of modules 1 Radio Module Type LTE/WCDMA/GNSS radio module Model LM940 Manufacturer Telit HW Version 2.0 SW Version 24.01.514 FCC-ID RI7LM940 IC None Antenna 1 & 2 (same type) Type External detachable Model 88977 Manufacturer DELOCK Gain FDD2, FDD4, FDD25, FDD66: 1.5 dBi FDD12, FDD13, FDD17, FDD29: 1.5 dBi FDD5, FDD26: 0 dBi FDD7: 4 dBi (manufacturer declaration) Supply Voltage V NOM 120 VAC AC/DC-Adaptor Model AKM65US12 Vendor XP Power Input 100 – 240 V AC Output 12 V DC Manufacturer BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 15 of 51 1.3 Support Equipment Product Type Device Manufacturer Model Comment SIM Communication Tester R&S CMW500 Base Station Simulator AE single-board computer Raspberry Pi Foundation Raspberry Pi 4 Model B provided by customer (4 pieces) CBL Ethernet cable unspecified unspecified provided by customer AE SIM Card Comprion form factor 2FF provided by Eurofins Description: AE Auxiliary Equipment SIM Simulator CBL Connecting Cable SFT Software Comment: Test Report No.: G0M-2206-1512-TFCMOCORSE-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 16 of 51 1.4 Test Modes Mode Description LTE FDD 2 / QPSK LTE FDD 2 / PMAX Channel = 18900 Mode = RMC TPC = Max. Power Modulation = QPSK Bandwidth = 20 MHz Number of resource blocks = 1 Resource block offset = 0 Duty cycle = 100 % LTE FDD 2 / QAM Channel = 19100 Mode = RMC TPC = Max. Power Modu…

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SPORTON INTERNATIONAL INC. Page Number : 1 of 31 TEL : 886-3-327-3456 Report Issued Date : Jul. 14, 2017 FAX : 886-3-328-4978 Report Version : Rev. 01 FCC ID : RI7LM940 Report Template No.: BU5-FGLTE Version 2.0 FCC RF Test Report Report No. : FG750208B FCC RF Test Report APPLICANT : Telit Wireless Solutions Co., Ltd. EQUIPMENT : LM940 BRAND NAME : TELIT MODEL NAME : LM940 FCC ID : RI7LM940 STANDARD : 47 CFR Part 2, 22(H), 24(E), 27 CLASSIFICATION : PCS Licensed Transmitter (PCB) The product was received on May 02, 2017 and completely tested on Jul. 04, 2017. We, SPORTON INTERNATIONAL INC., would like to declare that the tested sample has been evaluated in accordance with the test procedures given in ANSI / TIA / EIA-603-D-2010 and the testing has shown the tested sample to be in compliance with the applicable technical standards. The test results in this report apply exclusively to the tested model / sample. Without written approval of SPORTON INTERNATIONAL INC., the test report shall not be reproduced except in full. Reviewed by: Joseph Lin / Supervisor Approved by: Jones Tsai / Manager SPORTON INTERNATIONAL INC. No. 52, Hwa Ya 1 st Rd., Hwa Ya Technology Park, Kwei-Shan District, Tao Yuan City, Taiwan, R.O.C. SPORTON INTERNATIONAL INC. Page Number : 2 of 31 TEL : 886-3-327-3456 Report Issued Date : Jul. 14, 2017 FAX : 886-3-328-4978 Report Version : Rev. 01 FCC ID : RI7LM940 Report Template No.: BU5-FGLTE Version 2.0 FCC RF Test Report Report No. : FG750208B TABLE OF CONTENTS REVISION HISTORY .......................................................................................................................................... 3 SUMMARY OF TEST RESULT ......................................................................................................................... 4 1 GENERAL DESCRIPTION .......................................................................................................................... 6 1.1 Applicant ............................................................................................................................................ 6 1.2 Manufacturer ...................................................................................................................................... 6 1.3 Product Feature of Equipment Under Test ...............................................................................…

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