QRI-CMS4GWWQ1CardioMessenger Smart / Telemonitoring System

CardioMessenger Smart Transmitter for the BIOTRONIK Home Monitoring System Technical Manual 484650 Revision: O (2026-06-10) © 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. BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel+49 (0) 30 68905-0 [email protected] www.biotronik.com Table of Contents 3 Table of Contents 1About this Technical Manual......................................................................................5 Conventions.......................................................................................................................................5 2Product Description....................................................................................................7 Intended Purpose..............................................................................................................................7 Indications.........................................................................................................................................7 Contraindications..............................................................................................................................7 Residual Risks...................................................................................................................................8 Intended Clinical Benefit..................................................................................................................8 Patient Target Group........................................................................................................................8 Part of the Body Applied or Interacted With....................................................................................8 Expected Longevity...........................................................................................................................8 Product identification........................................................................................................................8 Intended Conditions of Use..............................................................................................................9 3Precautionary Measures............................................................................................10 4First Steps..................................................................................................................11 Check the Package Contents...........................................................................................................11 Where Do I Put the CardioMessenger Smart?................................................................................11 How Do I Connect the CardioMessenger Smart?............................................................................12 How Do I Use the CardioMessenger Smart?...................................................................................13 How Do I Turn Off the CardioMessenger Smart?............................................................................13 5The Display of the CardioMessenger Smart...............................................................14 6Functions....................................................................................................................15 Self-Test............................................................................................................................................15 Callback Function.............................................................................................................................15 7Error Resolution.........................................................................................................17 Error Type A - No Power Supply......................................................................................................17 Error Type B - Self-Test Failed........................................................................................................17 Error Type C - No Mobile Connection..............................................................................................18 8Handling.....................................................................................................................19 Charging............................................................................................................................................19 Cleaning............................................................................................................................................19 Maintenance......................................................................................................................................20 Reuse.................................................................................................................................................20 Disposal.............................................................................................................................................20 9Appendix.....................................................................................................................21 Technical Data..................................................................................................................................21 Country-Related Information...........................................................................................................22 Symbols.............................................................................................................................................24 Legend for the Label.........................................................................................................................25 Electromagnetic Emitted Interference............................................................................................26 Table of Contents 4 R…

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Test Report No.: TestSetup Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 1 ANNEX A Test setup photos Test Setup - I Test Setup - II

SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/1 Report No.: SZCR240700274102 Page: 1 of 38 Keny Xu EMC Laboratory Manager TEST REPORT Application No.: SZCR2407002741MO Applicant: Telit Communications S.p.A. Address of Applicant: Via Stazione di Prosecco 5/b, 34010 Sgonico – Trieste, Italy Manufacturer: Telit Communications S.p.A. Address of Manufacturer: Via Stazione di Prosecco 5/b, 34010 Sgonico – Trieste, Italy Factory: FUYU PRECISION COMPONENT CO., LTD Address of Factory: Lot M1, Lot F and Lot T1 Quang Chau Industrial Zone, Van Trung Ward, Viet Yen Town, Bac Giang Province, Vietnam Equipment Under Test (EUT): EUT Name: Radio Module Model No.: LE910Q1-WW Trade Mark: Telit Cinterion FCC ID: RI7LE910Q1WW Standard(s) : 47 CFR Part 2 47 CFR Part 22 47 CFR Part 24 47 CFR Part 27 47 CFR Part 90 Date of Receipt: 2024-07-12 Date of Test: 2024-07-16 to 2024-11-20 Date of Issue: 2024-11-21 Test Result: Pass * In the configuration tested, the EUT complied with the standards specified above. SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/1 Report No.: SZCR240700274102 Page: 2 of 38 Revision Record Version Chapter Date Modifier Remark 01 2024-11-21 Original Authorized for issue by: Calvin Weng/Project Engineer Eric Fu/Reviewer SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/1 Report No.: SZCR240700274102 Page: 3 of 38 2 Test Summary Test Item FCC Rule No. Requirements Verdict Effective (Isotropic) Radiated Output Power Data §2.1046 §22.913 §24.232 §27.50(b) §27.50(c) §27.50(d) §27.50(h) §27.1507(4) §90.635 ERP≤ 7W(LTE Band 5,26b) EIRP≤ 2W(LTE Band 2,25) ERP≤ 3W(LTE Band 13) ERP≤ 3W(LTE Band 12) EIRP≤ 1W(LTE Band 4,66) EIRP≤ 2W(LTE Band 7,38,41) ERP≤ 3W(LTE Band 8) ERP≤ 100W(LTE Band 26a) PASS Peak-Average Ratio §22.913 §24.232 §27.50(a) §27.50(d) §27.1507(d) ≤13dB PASS Bandwidth §2.1049(h) OBW: No limit EBW: No limit PASS Band Edge Compliance §2.1051 §22.917 §24.238 §27.50(g) §27.50(h) §27.50(m) §27.53(c) §27.1509 §90.691 ≤ -13dBm (LTE Band5,26b) ≤ -13dBm (LTE Band2,25) ≤ -13dBm (LTE Band12) ≤ -13dBm (LTE Band4,66) Refer to clause 6.4 for LTE Band7,38,41 Refer to clause 6.4 for LTE Band13 ≤ -13dBm (LTE Band8) Refer to clause 6.4 for LTE Band26a PASS Spurious emissions at antenna terminals §2.1051 §22.917 §24.238 §27.50(g) §27.50(h) §27.50(m) §27.53(c) §27.1509 §90.691 ≤ -13dBm (LTE Band5,26b) ≤ -13dBm (LTE Band2,25) ≤ -13dBm (LTE Band12) ≤ -13dBm (LTE Band4,66) Refer to clause 6.5 for LTE Band7,38,41 Refer to clause 6.5 for LTE Band13 ≤ -13dBm (LTE Band8) Refer to clause 6.5 for LTE Band26a PASS SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/1 Report No.: SZCR240700274102 Page: 4 of 38 Field strength of spurious radiation §2.1051 §22.917 §24.238 §27.50(g) §27.50(h) §27.50(m) §27.53(c) §27.1509 §90.691 ≤ -13dBm (LTE Band5,26b) ≤ -13dBm (LTE Band2,25) ≤ -13dBm (LTE Band12) ≤ -13dBm (LTE Band4,66) Refer to clause 6.6 for LTE Band7,38,41 Refer to clause 6.6 for LTE Band13 ≤ -13dBm (LTE Band8) Refer to clause 6.6 for LTE Band26a PASS Frequency stability §2.1055 §22.355 §24.235 §27.54 §90.213 ≤ ±2.5ppm. PASS SGS-CSTC Standards Technical Services Co., Ltd. Shenzhen Branch SZEMC-TRF-01 Rev. A/1 Report No.: SZCR240700274102 Page: 5 of 38 3 Contents Page 1 Cover Page ......................................................................................................................................... 1 2 Test Summary ..................................................................................................................................... 3 3 Contents ............................................................................................................................................. 5 4 General Information............................................................................................................................ 7 4.1 Details of E.U.T. ........................................................................................................................... 7 4.2 Test Frequency ............................................................................................................................ 8 4.3 Test Environment ........................................................................................................................11 4.4 Description of Support Units ........................................................................................................11 4.5 Measurement Uncertainty ...........................................................................................................11 4.6 Test Location ..............................................................................................................................12 4.7 Test Facility .................................................................................................................................12 4.8 Deviation from Standards ............................................................................................................12 4.9 Abnormalities from Standard Conditions ......................................................................................12 5 Equipment List ..................................................................................................................................13 6 Radio Spectrum Matter Test Results ................................................................................................15 6.1 Effective (Isotropic) Radiated Output Power Data ........................................................................15 6.1.1 E.U.T. Operation .....................................................................................................................15 6.1.2 Test Setup Diagram ................................................................................................................15 6.1.3 Measurement Data................................................…

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Test Report No.: G0M-2505-3075-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 46 RADIO REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) Report Reference No G0M-2505-3075-TFC95IMR-V01 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation DAkkS - Registration number : D-PL-12092-01-03 (ISED) ISED Testing Laboratory site: 3470A-2 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 According to FCC/ rules Standard 47 CFR Part 95I Non-Standard Test Method None Equipment under Test (EUT): Product Description CardioMessenger Smart / Telemonitorig System Model(s) CardioMessenger Smart 4G Additional Model(s) None Brand Name(s) BIOTRONIK Hardware Version(s) A Software Version(s) ULP_HIGH_1_37_0, ULP_LOW_1_17_0, LTE: M0Y.100003, SMARTAPP 1.x FCC-ID QRI-CMS4GWWQ1 Test Result PASSED Test Report No.: G0M-2505-3075-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 46 Possible test case verdicts: Required by standard but not tested N/T Not required by standard N/R Not applicable to EUT N/A Test object does meet the requirement P(PASS) Test object does not meet the requirement F(FAIL) Testing: Test Lab Temperature 20 - 23 °C Test Lab Humidity 32 – 38 % Date of receipt of test item 2024-10-10 Report: Compiled by Azamat Ibraimov Tested by (+ signature) (Responsible for Test) Azamat Ibraimov ....................................................... Approved by (+ signature) (Senior Radio Expert) Radwan Jaafar ....................................................... Date of Issue 2026-06-30 Total number of pages 46 General Remarks: The test results presented in this report relate only to the object tested. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. Additional Comments: None Test Report No.: G0M-2505-3075-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 46 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2026-06-30 Initial Release -- Test Report No.: G0M-2505-3075-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 46 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-2505-3075-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 46 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Photos – Equipment External ........................................................................................................................ 7 1.2 Photos – Equipment Internal ....................................................................................................................... 12 1.3 Photos – Test Setup .................................................................................................................................... 14 1.4 Support Equipment ...................................................................................................................................... 16 1.5 Test mode duty cycle .................................................................................................................................. 17 1.6 Test Modes ................................................................................................................................................. 19 1.7 Test Frequencies ......................................................................................................................................... 20 1.8 Sample emission level calculation ............................................................................................................... 21 1.9 Measurement Uncertainties ........................................................................................................................ 22 2 Result Summary ............................................................................................................................... 23 3 Test Conditions and Results .......................................................................................................... 24 3.1 Test Conditions and Results - Transmitter output power ............................................................................. 24 3.2 Test Conditions and Results - Band-edge and In-band Emissions ............................................................. 26 3.3 Test Conditions and Results - Transmitter unwanted emissions ................................................................. 28 ANNEX A Transmitter output power ................................................................................................................. 31 ANNEX B Band-edge and In-band Emissions .................................................................................................. 34 ANNEX C Antenna Pattern ............................................................................................................................... 38 ANNEX D Transmitter spurious emissions ....................................................................................................... 41 Test Report N…

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Test Report No.: G0M-2505-3075-EF0115B-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 50 EMC TEST REPORT FCC CFR Title 47 / Chapter I / Subchapter A / Part 15 / Subpart B ISED ICES-003 Issue 7 Report Reference No G0M-2505-3075-EF0115B-V02 Testing Laboratory Eurofins Product Service GmbH Address Storkower Str. 38c 15526 Reichenwalde Germany Accreditation ISED testing laboratory: CN 3470A FCC Filed Test Laboratory, Reg.-No.: 96970 Applicant BIOTRONIK SE & Co. KG Address Woermannkehre 1 12359 Berlin GERMANY Test Specification Standard(s) FCC CFR Title 47 / Chapter I / Subchapter A / Part 15 / Subpart B ISED ICES-Gen Issue 2 ISED ICES-003 Issue 7 ANSI C63.4:2014+A1:2017 Equipment under Test (EUT): Product Description CardioMessenger Smart / Telemonitorig System Model(s) CardioMessenger Smart 4G Brand Name(s) BIOTRONIK Hardware Version(s) A Software Version(s) ULP_HIGH_1_37_0, ULP_LOW_1_17_0, LTE: M0Y.100003, SMARTAPP 1.x FCC ID QRI-CMS4GWWQ1 IC N/A Test Result PASSED Test Report No.: G0M-2505-3075-EF0115B-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 50 Possible test case verdicts: required by standard but not tested N/T not required by standard N/R required by standard but not appl. to test object N/A test object does meet the requirement P(PASS) test object does not meet the requirement F(FAIL) Testing: Date of receipt of test item 2026-02-17 Report: Compiled by Matthias Handrik Tested by (+ signature) (Responsible for Test) Matthias Handrik Approved by (+ signature) (Head of Lab) Stephan Liebich Date of Issue 2026-06-16 Total number of pages 50 General Remarks: 1. The above equipment has been tested by Eurofins Product Service GmbH, and found compliance with the requirements set forth in the technical standards mentioned above. The results of testing in this report apply only to the product/system, which was tested. Other similar equipment will not necessarily produce the same results due to production tolerance and measurement uncertainties. 2. The test results are valid only for samples provided by customers and under the test conditions described in this report. 3. This report shall not be reproduced except in full, without the written approval of Eurofins Product Service GmbH. 4. The relevant information is provided by customer in this test report. According to the correctness, appropriateness or completeness of the information provided by the customer, if there is any doubt or error in the information which affects the validity of the test results, the laboratory does not take the responsibility. Statement concerning the uncertainty of the measurement systems used for decisions on conformity (decision rule): The Decision Rule is applied on the basis of CISPR 16-4-2 and/or IEC 61000-4-x (TR 61000-1-6) and their national publications. These standards provide guidance on how to calculate and apply measurement uncertainty whilst providing maximum uncertainties allowance. In all cases due consideration will be given to ILAC-G8:09/2019. Compliance or non-compliance with a disturbance limit is determined in the following manner. - If U lab is less than or equal to U cispr , then: compliance is deemed to occur if no measured disturbance level exceeds the disturbance limit; non-compliance is deemed to occur if any measured disturbance level exceeds the disturbance limit. - If U lab is greater than U cispr , then: compliance is deemed to occur if no measured disturbance level, increased by (U lab - U cispr ), exceeds the disturbance limit; non-compliance is deemed to occur if any measured disturbance level, increased by (U lab - U cispr ), exceeds the disturbance limit. Where appropriate for the test, for example for EMC pulsed immunity tests, the laboratory has demonstrated, by calibrating its equipment and facilities, that it complies with the above requirements and therefore no allowance of uncertainties has been given to the tolerances. Additional Comments: None Test Report No.: G0M-2505-3075-EF0115B-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 50 ABBREVIATIONS AND ACRONYMS Acronyms Acronym Description 5G 5 th Generation AE Auxiliary equipment AM Amplitude modulation AMN Artificial Mains Network CDN Coupling/decoupling network CR Continuous phenomena applied to receiver CT Continuous phenomena applied to transmitter EPS External power supply EUT Equipment Under Test E-UTRA Evolved Universal Terrestrial Radio Access FCC Federal Communications Commission GSM Global System for Mobile communication LTE Long Term Evolution NR New Radio RGP Reference ground plane IPT Inductive power transfer ISED Innovation, Science and Economic Development Canada NSA Normalized site attenuation RF Radio frequency SVSWR Site voltage standing wave ratio T NOM Nominal operating temperature TR Transient phenomena applied to receiver TT Transient phenomena applied to transmitter UTRA Universal Terrestrial Radio Access UMTS Universal Mobile Telecommunications System V NOM Nominal supply voltage WNP Wired network port Test Report No.: G0M-2505-3075-EF0115B-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 50 VERSION HISTORY Version History Version Issue Date Remarks Revised By 01 2026-03-19 Initial Release -- 02 2026-06-16 Replaced document: G0M-2505-3075-EF0115B-V01 Replaced by: G0M-2505-3075-EF0115B-V02 Changes: Used LTE bands of the EUT. Remeasurement of radiated and conducted emission measurements. Update equipment list of used Temperature/Humidity Sensor. M. Handrik Test Report No.: G0M-2505-3075-EF0115B-V02 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 50 REPORT INDEX 1 Equipment (Test Item) Under Test................................................................................................... 6 1.1 Equipment Ports ................................................................…

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Annex A101 - Photographs No. 1-0234-25-02-03_TR1-A101-R01 March 11, 2026 DescriptionPhotos of EUT and test position This document is electronically signed and valid without handwritten signature. Public keys for verifcation of the electronic signatures can be requested at the testing laboratory. Alexander Hnatovskiy Coordinator Area Radio Labs authorized by cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 1 of 8 Photo 1 DUT - front view Photo 2 DUT - back view cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 2 of 8 Photo 3 DUT - back view opened Photo 4 DUT - left view cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 3 of 8 Photo 5 Test position front side without any distance Photo 6 Test position back side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 4 of 8 Photo 7 Test position left side without any distance Photo 8 Test position right side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 5 of 8 Photo 9 Test position top side without any distance Photo 10 Test position bottom side without any distance cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 6 of 8 Photo 11 Test position front side without any distance with foam Photo 12 Test position back side without any distance with foam cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 7 of 8 Document History End of document ReleaseApplied changesRelease date R01initial releaseMarch 11, 2026 cetecom advanced GmbH Untertuerkheimer Str. 6-10, 66117 Saarbruecken Document No. 1-0234-25-02-03_TR1-A101-R01 Page 8 of 8

© cetecom advanced GmbH Page 1 of 53 TEST REPORT Test Report No.: 1-0234-25-02-03_TR1-R01 Testing Laboratory Applicant cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken / Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://cetecomadvanced.com e-mail: [email protected] Accredited Testing Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS). The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate with the registration number: D-PL-12047-01-00. ISED Testing Laboratory Recognized Listing Number: DE0001 FCC designation number: DE0002 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin/GERMANY Phone: +49 30 68905-1224 Contact: Dirk König e-mail: [email protected] Phone: +49 30 68905 1291 Fax: +49 30 68905 961291 Manufacturer BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin/GERMANY Test Standards IEC/IEEE 62209-1528:2020 Measurement procedure for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices – Part 1528: Human models, instrumentation, and procedures (Frequency range of 4 MHz to 10 GHz) RSS-102 Issue 6 Radio Frequency Exposure Compliance of Radiocommunication Apparatus (All Frequency Bands) For further applied test standards please refer to section 3 of this test report. Test Item Kind of test item: CardioMessenger Smart Device type: portable device Model name: CardioMessenger Smart 4G S/N serial number: 65110007 FCC-ID: QRI-CMS4GWWQ1 IMEI-Number: 355288940063680 Hardware status: -/- Software status: -/- Frequency: see technical details Antenna: integrated antenna Battery option: Lithium-ion battery UF463443GU 3.7 V / 820 mAh Test sample status: production unit Exposure category: general population / uncontrolled environment This test report is electronically signed and valid without handwritten signature. For verification of the electronic signatures, the public keys can be requested at the testing laboratory. Test Report authorised: Test performed: Alexander Hnatovskiy Obada Abo Oun Coordinator Area Testing Manager Regulatory Services Radio Regulatory Services Radio Test report no.: 1-0234-25-02-03_TR1-R01 © cetecom advanced GmbH Page 2 of 53 1 Table of contents 1 Table of contents ............................................................................................................................................ 2 2 General information ....................................................................................................................................... 4 2.1 Notes and disclaimer .......................................................................................................................... 4 2.2 Application details ............................................................................................................................... 4 2.3 Statement of compliance .................................................................................................................... 4 2.4 Technical details .................................................................................................................................. 5 2.5 Transmitter and Antenna Operating Configurations ....................................................................... 5 3 Test standards/ procedures references ....................................................................................................... 6 3.1 RF exposure limits .............................................................................................................................. 7 4 Reporting statements of conformity – decision rule…

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