2AB2MPECGT-IIIPocket ECG Monitor

revised: September 09, 2014 USER MANUAL PocketECG III DUAL CHANNEL Warsaw 2014 0197 Page 2 of 118 Copyright 2014 MEDICALGORITHMICS. No one is permitted to reproduce or duplicate, in any form, this manual or any part thereof without permission from MEDICALGORITHMICS. MEDICALGORITHMICS assumes no responsibility for any injury or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions, cautions, warnings, or statement of intended use published in this manual. Manufactured by: M EDICALGORITHMICS SA Al. Jerozolimskie 81, 02-001 Warsaw, Poland tel./fax.: +48 22 825 12 49 e-mail: [email protected] web: www.medicalgorithmics.com Page 3 of 118 TABLE OF CONTENTS 1. PocketECG III description 1.1. PocketECG III components 1.2. PocketECG III architecture 1.2.1. Transmission and analysis delay 1.3. Data transmission technologies 1.3.1. Mobile telephony network 1.3.2. Encrypted internet channel 1.3.3. Micro SD card (optional) 1.3.4 Information to user 2. Symbols glossary 3. Warnings and cautions 3.1. Warnings 3.1.1. PocketECG transmitter 3.1.2. PC client application 3.2. Cautions 4. Intended use 5. Contraindications 6. Accessories A. POCKETECG TRANSMITTER 7. Handling the device and its accessories 7.1. Starting the device 7.2. Main and backup batteries 7.2.1. Main battery charging 7.2.2. Backup battery charging 7.3. Stopping the device 7.4. SIM and flash memory cards 8. Test preparation 9. Supervisor and patient views 9.1. Supervisor view 9.1.1. Start/stop button 9.1.2. View tab 9.1.3. Settings tab Page 4 of 118 9.2. Patient view 9.3. Method for calculating pause and heart rate 10. Alarms 11. Data structure and transmission to the remote server 12. Maintenance 12.1. Inspection of the device 12.2. Testing the device 12.3. Cleaning the device 12.4. Storing the device 12.5. Software updates 13. Safety rules for using the PocketECG transmitter 13.1. Electromagnetic compatibility (EMC) B. PC CLIENT SOFTWARE 14. Equipment requirements 15. Installation 16. Distribution 17. Overview 17.1. Communication with remote server 18. Navigator 18.1. Introduction 18.2. Navigator toolbar 18.3. Adding and editing patient and specialist data 18.3.1. Patients 18.3.2. Specialists 18.3.3. Relations between specialists, patients and PocketECG transmitters 18.4. Assigning patients / specialists to recording session 18.5. Downloading and removing recording session data 18.6. Remote communication with the transmitter 18.7. Communication with the SD card through USB 19.Event View 19.1. Introduction 19.2. Filtering and sorting of the events list 19.3. Events reviewing Page 5 of 118 19.4. Navigation through the ECG recording 19.5. ECG display settings and transmitter settings 20. Full Disclosure 20.1. Introduction 20.2. Navigation through the ECG recording 20.3. ECG display settings and re-annotations 21. Trends 21.1. Acceleration trend 22. Impressions and Findings 23. Reports 23.1. Introduction 23.2. Reports viewing 23.3. Reports editing 24. Garbage 25. Archive 26. Tools Menu C. ADDITIONAL INFORMATION 27. Medical incident 28. Troubleshooting 29. Technical parameters 30. Service 31. Declaration of conformity 32. Limited warranty statement 33. Software license agreement Page 6 of 118 1. POCKETECG III DESCRIPTION 1.1. PocketECG III components The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III consists of: • PocketECG transmitter, model: PocketECG III, type: PECGT-III with the following accessories: o Two rechargeable batteries, type: PECGB-III, o The AC plug-in battery charger, type: PECGC-III, • PC Client software • User manual (hardcopy) for the patients The Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECG III is compliant with: • 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. This user manual describes PocketECG transmitter, its accessories and PocketECG PC client software. 1.2. PocketECG III architecture The functional block diagram of PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic System in combination with the data transmission to the remote server is presented in Fig. 1. Page 7 of 118 Fig. 1 Functional block diagram of PocketECG III Medicalgorithmics Unified Arrhythmia Diagnostic System The patient heart activity is digitized using a PocketECG transmitter. The transmitter is equipped with digital accelerometer, generating signals corresponding to the patient physical activity. An algorithm, operating on the PocketECG transmitter automatically analyzes the acquired ECG in real-time and transmits both: the ECG and acceleration data to the remote server accessible by a Monitoring Center for reviewing by trained medical staff. The ECG data comprises of ECG annotations for all detected heart beats and the entire ECG signal. The acceleration data comprises of results of patient activity estimation Page 8 of 118 along with the waveforms of the acceleration signals. All detection results along with the waveforms of the ECG and acceleration signals may be reviewed using a PocketECG Client - PC based application. Optionally, the ECG and acceleration data may be downloaded to the Pocket ECG Client application from the SD card of PocketECG transmitter using standard SD card reader connected to the PC through USB interface. 1.2.1 Transmission and analysis delay The ECG signal is interpreted by the software of PocketECG transmitter with few seconds delay, which is relatively quick considering the monitoring duration of a patient – i.e. which may last from one day to several weeks. Therefore analysis with such short delay is considered as performed in real-time. The transmission of data chunks is also performed fairly frequently, with regard to the potential monitoring. The use of this approach is to provide the arrhythmia analysis results to the …

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SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road, Suite 100, Suwanee, GA 30024 t (770) 570-1800 f (770) 277-8187 www.sgs.com/cts Member of the SGS Group (SGS SA) October 31, 2014 Telecommunication Certification Body (and/or) Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Subject: Application for Original Certification, FCC ID: 2AB2MPECGT-III Dear Application Examiner, Medicalgorithmics SA is submitting this application for certification of model PEGCT-III, under FCC ID: 2AB2MPECGT-III. The device is a handheld computer containing radio modules: the Sierra Wireless SL8090 (a GSM/WCDMA radio) and the Texas Instruments TiWi5(DNP) module (802.11 a/b/g/n -Bluetooth radio). System authorization is sought under FCC 22e, FCC 24h, FCC 15.407 and FCC 15.247. Internal and external photos for the device have been submitted with this application The 802.11 and Bluetooth radios share their antenna and cannot transmit simultaneously. Cellular communication cannot be transmitted simultaneously with either Bluetooth or 802.11. A SAR evaluation was performed. The antenna is integral to the handheld computer and is not user accessible, therefore compliant to FCC 15.203 unique antenna connector requirements. Your efforts in reviewing this application are greatly appreciated. Please contact me if there are questions or additional information needed concerning this request. Sincerely, David Schramm EMC Manager—SGS North America— Signing for: Medicalgorithmics SA tel 770-570-1819 620 Old Peachtree Rd NW Suite 100 Suwanee GA 30024

Label Under Battery

Test Report Number: 3374150EMC03 Rev: 2 Medicalgorithmics / PocketECG III Page: 1 of 39 Remarks: This report details the results of the testing carried out on one sample, the results contained in this test report do not relate to other samples of the same product. The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. This report may only be reproduced and distributed in full. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. Any mention of SGS International Electrical Approvals or Testing done by SGS International Electrical Approvals in connection with distribution or use of the product described in this report must be approved by SGS international Electrical Approvals in writing. EMC Test Report Project Number: 3374150 Report Number: 3374150EMC03 Revision Level: 1 Client: Medicalgorithmics Equipment Under Test: Mobile Computer with WCDMA/GSM/WiFi/BT Model Number: PocketECG III Applicable Standards: FCC Part 15 Subpart C, § 15.247 (FHSS) RSS-210, Issue 8, December 2010 ANSI C63.10: 2009 Report issued on: 09OCT2014 Test Result: Compliant Tested by: Brian Forster, EMC Engineer Reviewed by: David Schramm, EMC Manager Test Report Number: 3374150EMC03 Rev: 2 Medicalgorithmics / PocketECG III Page: 2 of 39 SGS North America Inc. Consumer Testing Services 620 Old Peachtree Road NW, Suite 100, Suwanee, GA 30024 t (770) 570-1800 www.us.sgs.com/cts Member of the SGS Group (SGS SA) Table of Contents 1 SUMMARY OF TEST RESULTS ..................................................................................................................................... 4 1.1 MODIFICATIONS REQUIRED FOR COMPLIANCE .............................................................................................................. 4 2 GENERAL INFORMATION ............................................................................................................................................. 5 2.1 CLIENT INFORMATION ................................................................................................................................................... 5 2.2 TEST LABORATORY ....................................................................................................................................................... 5 2.3 GENERAL INFORMATION OF EUT .................................................................................................................................. 5 2.4 EUT CONNECTION BLOCK DIAGRAM ............................................................................................................................ 6 2.5 SYSTEM CONFIGURATIONS ............................................................................................................................................ 6 3 PSEUDO-RANDOM HOP SEQUENCE ........................................................................................................................... 7 3.1 TEST RESULT ................................................................................................................................................................. 7 3.2 TEST METHOD ............................................................................................................................................................... 7 4 CHANNEL SEPARATION ................................................................................................................................................ 8 4.1 TEST RESULT ................................................................................................................................................................. 8 4.2 TEST METHOD ............................................................................................................................................................... 8 4.3 TEST SITE ...................................................................................................................................................................... 8 4.4 TEST EQUIPMENT .......................................................................................................................................................... 8 4.5 TEST DATA .................................................................................................................................................................... 9 5 NUMBER OF HOPPING CHANNELS .......................................................................................................................... 10 5.1 TEST RESULT ............................................................................................................................................................... 10 5.2 TEST METHOD ............................................................................................................................................................. 10 5.3 TEST SITE .................................................................................................................................................................... 10 5.4 TEST EQUIPMENT ........................................................................................................................................................ 10 5.5 TEST DATA .................................................................................................................................................................. 11 6 DWELL TIME .................................................................................................................................................................. 12 6.1 TEST RESULT ............................................................................................................................................................... 12 6.2 TEST METHOD .................................................…

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