2AB2MP4TRAAPocketECG IV transmitter

1 / 11 PocketECG IV DUAL CHANNEL Instructions For Use MEDICALGORITHMICS S.A. Aleje Jerozolimskie 81, 02-001 Warsaw, Poland e-mail: [email protected] web: www.medicalgorithmics.com 0197 January 10, 2019 | v. 3.0 2 / 11 INTENDED USE The PocketECG transmitter is intended to acquire, analyze, visualize, record or/and transmit the ECG acceleration data. The results of arrhythmia and ST elevation detection are displayed, stored or/and transmitted along with the ECG signals. The acceleration signals are analyzed in order to determine the physical activity of the patient. It is assumed that the device can further transmit the and acceleration signals along with analysis results using available wireless technologies. The PocketECG IV is intended for use under the supervision of a physician or those knowledgeable all aspects of ECG morphology, rhythm, and arrhythmias. Having fulfilled the working conditions specified in the manual, the device may be used when the patient is in the following places: clinic, hospital, outpatient cardiology clinic, house, business establishment, etc. CONTRAINDICATIONS The PocketECG IV is not intended to be used by patients who have been diagnosed with threatening arrhythmias and require spitalization or patients who require inpatient monitoring using a life-saving device. The Pocket ECG III is not intended for use in surgi cal rooms, intensive care units, intermediate or step -down units, emergency vehicles. The PocketECG IV is MR unsafe and should not be used in any magnetic resonance environment. COMPLIANCE The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG IV complies with the following regulations : the essential requirements of the Council Directive 93/42/EEC, the requirements of the United States Food and Drugs Administration, the requirements of the Health Canada Medical Devices Regulations. US Federal Law restricts this device to sale by or on the order of a physician. FCC REQUIREMENTS FCC ID: 2AB2MP4TRAA The device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications of any kind not expressly approved by Medicalgorithmics S.A. could void the user's authority to use ECG. COMPONENTS & ACCESSORIES The PocketECG transmitter, model: PocketECG IV, type: P4TR-AA-ADS (LTE version for Verizon), P4TR-BA-ADS (LTE version for AT&T) A Lithium-ion battery, type: PECGB-III, rated 3,7 VDC, 1700 mAh An AC plug-in charger type PECGC-III suitable for charging battery type PECGB-III, manufactured by Medicalgorithmics S.A., rated 100 VAC – 240 VAC, 0.2 A, 50/60 Hz MicroSD memory card PocketECG pouch Holster (optional, for indoor use only) Accessories which are needed to the proper operation but are not included in the PocketECG IV package: • SIM card, • ECG electrodes. 1 2 3 1 3 2 11 / 11 SYMBOLS USED ON POCKETECG TRANSMITTER CASING 0197 CE mark (Council Directive 93/42/EEC) Type BF applied part Manufacturer’s name and address Date of manufacture Consult instructions for use Warning Caution PocketECG transmitter includes radio wave transmitters Keep dry IP20 Protection against solid particles up to 12.5 mm (fingers or similar objects), lack of protection against ingress of water Dispose the device in compliance with appropriate regulations MR unsafe Serial number Brazilian National Institute of Metrology, Quality and Technology (Inmetro) certification mark Australian Communications and Media Authority (RCM) certification mark SIM card (GSM) MicroSD memory card MEDICAL INCIDENT, SERVICE, DECLARATION OF CONFORMITY • In the event of a medical incident, please notify the manufacturer immediately. • If you would like to receive the declaration of conformity, please contact the manufacturer. • Service is provided only by Medicalgorithmics S.A. In case of any product malfunction it shall be returned directly to manufacturer to the following address: M EDICALGORITHMICS S.A. Aleje Jerozolimskie 81 02-001 Warsaw, Poland e-mail: [email protected] COPYRIGHTS Copyright 2018 Medicalgorithmics S.A. No one is permitted to reproduce or duplicate, in any form, this instructions for use or any part thereof witho ut permission from Medicalgorithmics S.A. Medicalgorithmics S.A assumes no responsibility for any injury or for any illegal or improper use o f the product that may result from failure to use thi s product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. 10 / 11 WARNING: Sources of electromagnetic radiation like: • portable and mobile radio frequency (RF) communications equipment (e.g. cellular phones, mobile radio), • radio frequency identification systems (RFID) devices using one or more of the following wireless technologies: o Wi-Fi (IEEE 802.11), o Bluetooth (IEEE 802.15), o ZigBee (IEEE 802.15.4), o WiMAX (IEEE 802.16), o Ant, etc., • base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM, and FM radio broadcast and TV broadcast, • metal detectors, • diathermy, lithotripsy, electrocautery, radiofrequency identification (RFID), near field communication (NFC), electronic article surveillance (EAS) can affect the PocketECG transmitter. MAINTENANCE The PocketECG transmitter type: P4TR-AA-ADS, and P4-TR-BA-ADS and battery charger type: PECGC -III, manufactured by Medicalgorithmics S.A. are designed for 5 years continuous use if properly operated. Then the device should be recycled according to the local recycling program or refurbished by the manufacturer. CLEANING & STORING The outer surface of the transmitter, ECG lead wires and transmitter accessories (charger, batteries) can be wiped with a wet soft cloth and soft soap dissolved in water or an alcohol -based disinfecting agent (70 % ethanol or 70 % isopro…

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Subject: Use of LE866-SV1 documentation and FCC reports Dear Sir or Madam: Telit authorizes integrator/customer MEDICALgorithmics to use the LE866-SV1 construction documentation (schematics, BOM, Block diagrams, etc.) that must remain permanently confidential and the FCC reports for FCC certification of their P4TR-AA-ADS PocketECG transmitter MEDICALgorithmics may use MPE, part 15, 22, 24, 27 test reports along with all necessary documentation pertinent to Telit radio module LE866- SV1 and is authorized to use the company name “Telit”, product name “LE866-SV1” solely for the certification process of P4TR-AA-ADS PocketECG transmitter which have the Telit LE866-SV1 embedded. The Test Reports supplied by Telit to the FCC for our submission for grant are still representative of LE866-SV1 manufactured today. If you have any questions or concerns feel free to contact me. April 9, 2019 MEDICALgorithmics US Holding Corporation 251 Little Falls Drive Wilmington, DE 19808 USA Ken Bednasz Tel +1 919-415-1517 E-Mail [email protected] www.telit.com

P4TR-AA-ADS external photos Page 1 of 3 Fig.1 P4TR-AA-ADS top view P4TR-AA-ADS external photos Page 2 of 3 Fig.2 P4TR-AA-ADS bottom view (battery inserted) P4TR-AA-ADS external photos Page 3 of 3 Fig.3 P4TR-AA-ADS bottom view (without battery, visible marking location)

TECHNICAL MANUAL Telit LE866-SV1 Data Terminal Module External Pictures

P4TR-AA-ADS labels Page 1 of 2 Label for PocketECG transmitter (type P4TR-AA-ADS) Label for PocketECG battery (type PECGB-III) P4TR-AA-ADS labels Page 2 of 2 Label for PocketECG battery charger (type PECGC-III) - top view Label for PocketECG battery charger (type PECGC-III) - bottom view

P4TR-AA-ADS external photos Page 3 of 3 Fig.3 P4TR-AA-ADS bottom view (without battery, visible marking location)

TECHNICAL MANUAL Telit LE866-SV1 Data Terminal Module Pag.4 of 24 Rev.0 2019/02/20 Code: 1vv0301587 ANNEX 1 LE866-SV1 MODULE LABEL LAYOUT TECHNICAL MANUAL Telit LE866-SV1 Data Terminal Module P ag.5 of 24 Rev.0 2019/02/20 Code: 1vv0301587

P4TR-AA-ADS internal photos Page 1 of 4 Fig.1 P4TR-AA-ADS (bottom view without bottom enclosure) Fig.2 P4TR-AA-ADS (bottom view without screen and enclosure ) P4TR-AA-ADS internal photos Page 2 of 4 Fig.3 P4TR-AA-ADS HDI1 (top view) Fig.4 P4TR-AA-ADS HDI1 (bottom view ) P4TR-AA-ADS internal photos Page 3 of 4 Fig.5 P4TR-AA-ADS HDI2 (bottom view ) Fig.6 P4TR-AA-ADS HDI2 (top view ) P4TR-AA-ADS internal photos Page 4 of 4 Fig.7 LE866-SV1 module (top view) Fig.8 LE866-SV1 module (bottom view)

TECHNICAL MANUAL Telit LE866-SV1 Data Terminal Module Internal Pictures

Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.intertek.com Medicalgorithmics S.A. SAR TEST REPORT SCOPE OF WORK Specific Absorption Rate – Unified Arrhythmia Diagnostic System REPORT NUMBER 104137601LEX-002 ISSUE DATE 7/17/2020 PAGES 40 DOCUMENT CONTROL NUMBER Non-Specific EMC Report Shell Rev. December 2017 © 2017 INTERTEK This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. SPECIFIC ABSORBTION RATE TEST REPORT Report Number: 104137601LEX-002 Project Number: G104137601 Report Issue Date: 7/17/2020 Product Name: Unified Arrhythmia Diagnostic System Model Number: PocketECG IV Standards: FCC Part 2.1093 RSS-102 Issue 5 Tested by: Client: Intertek Testing Services NA, Inc. 731 Enterprise Drive Lexington, KY 40510 USA Medicalgorithmics S.A. Al. Jerozolimskie 81 02-001, Warsaw Poland Report prepared by Report reviewed by Bryan Taylor, Team Leader James Sudduth, Senior Staff Engineer Evaluation For: Medicalgorithmics S.A. Product: Unified Arrhythmia Diagnostic System SAR Test Report Date: 7/17/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 3 of 40 Report Number: 104137601LEX-002 TABLE OF CONTENTS 1 INTRODUCTION ..........................................................................................................................4 2 TEST SITE DESCRIPTION ...............................................................................................................5 3 JOB DESCRIPTION ..................................................................................................................... 10 4 SYSTEM VERIFICATION .............................................................................................................. 13 5 EVALUATION PROCEDURES ....................................................................................................... 18 6 CRITERIA .................................................................................................................................. 23 7 TEST CONFIGURATION .............................................................................................................. 23 8 TEST RESULTS ........................................................................................................................... 26 9 SAR DATA: ................................................................................................................................ 26 1.0 REFERENCES .......................................................................................................................... 31 APPENDIX A – SYSTEM VALIDATION SUMMARY ................................................................................ 32 APPENDIX B – WORST CASE SAR PLOTS ............................................................................................ 33 APPENDIX C – DIPOLE VALIDATION PLOTS ........................................................................................ 37 Evaluation For: Medicalgorithmics S.A. Product: Unified Arrhythmia Diagnostic System SAR Test Report Date: 7/17/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 4 of 40 Report Number: 104137601LEX-002 1 INTRODUCTION At the request of Medicalgorithmics S.A. the Unified Arrhythmia Diagnostic System was evaluated for SAR in accordance with the requirements for FCC Part 2.1093 and RSS-102 Issue 5. Testing was performed in accordance with IEEE Std 1528:2013, IEC62209-2:2010, and the Office of Engineering and Technology KDB 447498. Testing was performed at the Intertek facility in Lexington, Kentucky. For the evaluation, the dosimetric assessment system DASY52 was used. The total uncertainty for the evaluation of the spatial peak SAR values averaged over a cube of 1g tissue mass had been assessed for this system to be 22.2% from 300MHz – 3GHz and 24.6% from 3GHz – 6GHz. The Unified Arrhythmia Diagnostic System was tested at the maximum output power measured by Intertek. Maximum output power measurements are tabulated under Section 8 Test Results. The maximum spatial peak SAR value for the sample device averaged over 1g (for body worn mode) and 10g (for hand held mode) is shown below. Based on the worst-case data presented below, the Unified Arrhythmia Diagnostic System was found to be compliant with the 1.6 W/kg and 4W/kg requirements for general population / uncontrolled exposure. Table 1: Worst Case Reported SAR per Exposure Condition Device Position Transmit Mode Separation Distance TX Band Maximum Conducted Output Power (dBm) Reported SAR (W/kg) Limit (W/kg) Back Side, Extremity Exposure QPSK, 1RB 0mm Band 4, Low 22.58dBm 1.7316W/kg 4.00W/kg Back Side, Body Exposure QPSK, 1RB 5mm Band 4, High 22.58dBm 0.8414W/kg 1.6W/kg Evaluation For: Medicalgorithmics S.A. Product: Unified Arrhythmia Diagnostic System SAR Test Report Date: 7/17/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 5 of 40 Report Number: 104137601LEX-002 2 TEST SITE DESCRIPTION The SAR test site located at 731 Enterprise Drive, Lexington KY 40510 is comprised of the SPEAG model DASY 5.2 automated near-field scanning system, which is a package, optimized for dosimetric evaluation of mobile ra…

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Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.intertek.com Medicalgorithmics S.A. TEST REPORT SCOPE OF WORK EMC TESTING – POCKETECG III VLTE REPORT NUMBER 104137601LEX-001 ISSUE DATE 3/2/2020 PAGES 22 DOCUMENT CONTROL NUMBER Non-Specific EMC Report Shell Rev. December 2017 © 2017 INTERTEK This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Testing Services NA, Inc. EMC TEST REPORT (FULL COMPLIANCE) Report Number: 104137601LEX-001 Project Number: G104137601 Report Issue Date: 3/2/2020 Model(s) Tested: PocketECG III VLTE Standards: FCC Part 15B ICES-003 Issue 6 FCC Part 27 (Radiated Spurious Emissions) Tested by: Client: Intertek Testing Services NA, Inc. 731 Enterprise Dr. Lexington, KY 40510 USA Medicalgorithmics S.A. Al. Jerozolimskie 81 02-001, Warsaw Poland Report prepared by Report reviewed by Ben Coolbear, Engineer Bryan Taylor, Team Leader Evaluation For: Medicalgorithmics S.A. Product: PocketECG III VLTE EMC Test Report Date: 3/2/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 3 of 22 Report Number: 104137601LEX-001 Table of Contents 1 Introduction and Conclusion ..................................................................................................................... 4 2 Test Summary .......................................................................................................................................... 4 3 Client Information .................................................................................................................................... 5 4 Description of Equipment under Test and Variant Models .......................................................................... 6 5 System Setup and Method ........................................................................................................................ 7 6 Radiated Emissions ................................................................................................................................ 10 7 Revision History ..................................................................................................................................... 22 Evaluation For: Medicalgorithmics S.A. Product: PocketECG III VLTE EMC Test Report Date: 3/2/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 4 of 22 Report Number: 104137601LEX-001 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. 2 Test Summary Section Test full name Result 6 Radiated Emissions (Transmitters Idle) (FCC Part 15B, ICES-003 Issue 6, ANSI C63.4:2014) Compliant 6 Radiated Spurious Emissions (Transmitters Active) (FCC Par 27, ANSI C63.26:2015) Compliant Note: Since the PocketECG III VLTE is battery powered the conducted emissions tests from FCC Part 15B / ICES-003 did not apply. Evaluation For: Medicalgorithmics S.A. Product: PocketECG III VLTE EMC Test Report Date: 3/2/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 5 of 22 Report Number: 104137601LEX-001 3 Client Information This product was tested at the request of the following: Client Information Client Name: Medicalgorithmics S.A. Address: Al. Jerozolimskie 81 02-001, Warsaw Poland Contact: Przemyslaw Tadla Telephone: +48 733 888 7788 Email: [email protected] Manufacturer Information Manufacturer Name: Medicalgorithmics S.A. Manufacturer Address: Al. Jerozolimskie 81 02-001, Warsaw Poland Evaluation For: Medicalgorithmics S.A. Product: PocketECG III VLTE EMC Test Report Date: 3/2/2020 Non-Specific EMC Report Shell Rev. December 2017 Page 6 of 22 Report Number: 104137601LEX-001 4 Description of Equipment under Test and Variant Models Equipment Under Test Product Name PocketECG III VLTE Model Number P4TR-AA-ADS Serial Number TR0819-25620A Receive Date 12/1/2019 Test Start Date 11/6/2019 Test End Date 11/9/2019 Device Received Condition Good Test Sample Type Production Rated Voltage 3.6VDC Description of Equipment Under Test (provided by client) The PocketECG III VLTE is an ambulatory ECG device which analyzes electrographic signal in real time, classifies all detected heart beats and recognizes rhythm abnormalities. All detection results, including annotations for every detected heart beat and the ECG signal are transmitted via cellular telephony network to a remote server accessible by a Monitoring Center for reviewing by trained medical staff. 4.1 Variant Models: There were no v…

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5mm Separation for Body Exposure 0mm Separation for Extremity Exposure

DEKRA Certification, Inc. 405 Glenn Dr. Suite 12, Sterling, VA 20164 United States of America Report No: 2395ERM.001 03-25-2019 Appendix B :Photographs DEKRA Certification, Inc. 405 Glenn Dr. Suite 12, Sterling, VA 20164 United States of America Report No: 2395ERM.001 Page 2 of 4 03-25-2019 Figure B1. DUT Top View with antenna and cradle Figure B2. DUT Top View DEKRA Certification, Inc. 405 Glenn Dr. Suite 12, Sterling, VA 20164 United States of America Report No: 2395ERM.001 Page 3 of 4 03-25-2019 Figure B3. DUT Rear View Figure B4. Radiated Setup LR DEKRA Certification, Inc. 405 Glenn Dr. Suite 12, Sterling, VA 20164 United States of America Report No: 2395ERM.001 Page 4 of 4 03-25-2019 Figure B5. Radiated Setup HR