FCC ID: 2BA2T-LPC1 Wearable device to collect quantitative biometric data from the thoracic region of adult patients.

ES LifePath -

ELASTIC . :

CARE Mobile ECG and multi-sensor medical monitor Clinical Instructions for Use Version|

fersion 01 Ee ELASTIC CARE LifePath-c Mobile ECG and multi-sensor medical monitor Clinical Instructions for Use Version 01 vents LifePath -C Clinical Instructions for Use Copyright This publication is provided for informational purposes only and Elastic Care, Inc. makes no warranties, either express or implied, in this document. Information in this document is subject to change without notice, The entire risk of the use or the results of the use of th document remains with the user. Unless otherwise noted, the example companies, organiza-

tions, products, dornain names, e-mail addresses, logos, people, places, and events depicted herein are fictitious, and no association with any real company, organization, product, domain name, e-mail address, logo, person, place, or event is intended or should be inferred. Complying with all applicable copyright laws is the responsibility of the user. Without limiting the rights under copyright, no part of this document may be reproduced, stored in or Introduced into a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise), or for any purpose, without the express written permission of Elastic Care, nc is Elastic Care, Inc. may have patents, patent applications, trademarks, copyrights, or other intellectual property rights covering subject matter in this docurnent. Except as expressly provided in any written license agreement from Elastic Care, Inc, the furnishing of this. document does not give you any license to these patents, trademarks, copyrights, or other intellectual property. For additional information or assistance, please contact Flastic Care or an authorized Elastic Care representative in your area. 2023 Elastic Care, Inc. All rights reserved, ES rane LifePath -C Clinical Instructions for Use Preface Thank you for purchasing Lifepath-C. Carefully read this user manual for correct use of the unit. Keep this manual handy after reading. It will continue to be of your service in finding specific information about this instrument. This manual is also available online at:

www.elasticcare.com/support The information in this document at the time of publication is believed to be accurate in all respects but is subject to change without notice. Elastic Care assumes no responsibility for errors or omissions, and disclaims responsibility for any consequences resulting from the use of information Included herein. Additionally, Elastic care assumes no responsibility for the functioning of undescribed features or parameters and also does not assume any liability arising out of the application or use of any product, and specifically disclaims any and all liability, including without limitation consequential or incidental damages. Elastic Care products are not designed, intended or authorized for use in applications intended to support or sustain life, or for any application in which the failure of the Elastic Care product could create a situation where personal injury or death may occur. Should Buyer purchase or use Elastic Care products for any such unintended or unauthorized application, Buyer shall indemnify and hold Elastic Care harmless against all claims and damages. LifePath -C Clinica nstructic Contacts For support, or further information on this product, please contact:

Address Contact Elastic Care Inc. Web = wwwelasticcare.com 95 Apple Creek Blvd Email info@elasticcare.com Markham, Ontario, CA Phone +1833 GOMYECG (+1 833 466 9324) L3RIC7 Version History This document may be subject to change without notice. Version _ Description Release Date ol Initial release 2023/01/17 LifePath -C Clinical Instructions Table of Contents _ Warnings & Cautions 1 11 Operating Conditions 1 1.2. Warnings and Cautions 1 2 Symbols 4 3 LifePath-C Symbols 8 4 Standards v 5 Introduction 4 5.1 Intended Use 4 5.2 Intended User Knowledge Base 4 5.3 Contraindications 5 5.4 System Overview 15 6 Hardware Overview 16 7 Package Contents 19 8 Getting Started with LifePath-C 22 8.1 Receiving Elastic Care Login Credentials 22 8.2 Preparation 23 9 Setup 24 91 Turning ON Included Smartphone 25 9.2 Logging into the Elastic Care Mobile Application 26 9.3 Patient Onboarding 26 9.4 Campaign Configuration 28 9.5 Device and Patient Setup 30 Table of Contents 10 Operation 10.1 Operating Requirements 10.2 Elastic Care Mobile Application Overview 10.3 Starting Monitoring 10.4 Pre-Launch Check 10.5 Successful Pre-Launch Check 10.6 Monitoring 10.7. Monitoring Campaign Procedure 10.8 Pausing Monitoring 10.9 Resuming Monitoring 10.10 Monitoring Errors 1 Connectivity 11 Bluetooth Connection 11.2 Bluetooth Signal strength 11.3 Bluetooth Disconnection 1.4 Wi-Fi Disconnection 11.5 No Internet Connection 12 Wearable Medical Monitor Alerts 12.1 Vibration Alerts 12.2 LED Alerts 13 Battery and Power 13.1 Wearable Medical Monitor Battery Power 13.2 Spare Wearable Medical Monitor Battery 13.3. Battery Safety 13.4 Low Battery Warning 135 Swapping Batteries LifePath -C Clinic 38 38 39 46 47 49 ce) 51 52 52 53 58 58 59 60 63 64 65 6 66 67 67 67 67 68 6 LifePath -C Clinical Ins Table of Contents 14 Data Storage 141 Wearable Medical Monitor Data Storage 14.2 Smartphone Data Storage 15 Cleaning the LifePath-C System 15.1 Warnings and Cautions for Cleaning the LifePath-c System 15.2 Cleaning Procedure 15.3 Additional Cleaning Measures 15.4 Disposing of Used Consumables 16 maintenance 17 Campaign End 171. Campaign End- Stored Data 18 Removing and Returning 18.1 Removing LifePath-c 18.2 Returning LifePath-c 19 Third-Party Devices 191 Adding a Third-Party Device 19.2 Switching to a Third-Party Device 19.3 Using a Third-Party Device 20 thresholds for Vitals 21 Reports 22 Pre-Launch Check Errors B 84 85 86 86 87 89 89 a1 92 94 95 96 Ee Ease LifePath -C Clinical structions for Use Table of Contents 23 FAQ's 101 24 Troubleshooting 104 25 Technical Specifications 107 25.1 Wearable Medical Monitor 107 25.2 AC/DC Medical Power Supply 08 25.3 Wearable Medical Monitor Battery Charger 109 25.4 Vital Sign Measurement 109 Ee flasnie LifePath -C Clinical Instructic 1 Warnings, Cautions & Notes 1.1. Operating Conditions ue Temperature Limit 100 Vee on VO of Operation of device oe AP Charging of battery From 5 to 45C (41F to 113F) From 5C to 40C (41F to 104 F) ogy Relative Humidity Limit on a a me Operation of device ae Charging of battery aS 10% 10.9596 withoutcondensation ft J 10% to 90% without condensation tos Atmospheric Pressure Limit

5 Maintain atmospheric pressure from 70 kPa to 106 KPA, 1.2. Warnings and Cautions the text accompanying the symbol exposes the patient or operator to risk of serous injury, compromises safe operation of the device, or may result in adverse events associated with the operation of the LifePath-C system p The symbol shown to the left indicates a warning. Failure to heed The symbol shown to the left indicates a caution statement. Failure to heed the text accompanying the symbol may result in injury to the patient or operator, compromise the safe operation of the LifePath-C system, or may result in irreparable damage to the LifePath-C hardware. ol 2023/0//17 www.elasticcare.com Pagel Page 2 LifePath-C Inical Instructions for Use Warnings and Cautions Safety Warnings rN Not for use on patients/individuals less than 22 years of age. Not for use on patients requiring attended, in-hospital monitoring for life-threatening arrhythmias. Not for use on patients/individuals with any active implantable devices such as pacemakers, Not for use on patients during pregnancy. Not for use on patients/individuals with broken or fragile skin on the torso. Not for use on patients/individuals who are allergic to acryli adhesives. hydro gel, or silicone Do not use LifePath-C in an MRI suite or hyperbaric charnber. Remove LifePath-C system from patient prior to defibrillation. Do not tamper with, open up, or attempt to modify the Wearable Medical Monitor, Smartphone, Wearable Medical Monitor batteries, Cable Harness, Battery Dock Charger, or any adapters. Failure to comply can cause serious risk of injury, and irreparable damage to the components. Do not interact with the Wearable Medical Monitor or Smartphone while driving, Do not expose Wearable Medical Monitor, Wearable Medical Monitor Batteries, or Smartphone to fire or excessive heat. Do not expose the Wearable Medical Monitor, Wearable Medical Monitor Batteries, or any of Its accessories and components to magnetic fields, electrostatic discharge and thermal ignition sources. Do not attempt to connect any patient worn component to an electrical outet of any kind, Do not use the Wearable Medical Monitor, or any other components in the LifePath-C system, if it is damaged, as it may affect its functional use, intended use, and/or the safety of the wearer. www.elasticcare.com ol 2023/01/17 ol LifePath -C Clinical Instructions for Use Warnings and Cautions Cautions A Do not shower with the LifePath-C system. Do not get the Wearable Medical Monitor, batteries, cable harness, or other components wet. Do not attempt to plug in or use any third party cable harnesses with the Wearable Medical Monitor. Do not remove the Wearable Medical Monitor diagnostic port cover. Do not unplug the Cable Harness from the Wearable Medical Monitor while in a monitoring state, Do not detach or remove the Wearable Medical Monitor from the patient while in a monitoring state Do not discard of Wearable Medical Monitor batteries in the garbage. Thoroughly examine skin on patient's torso for lesions, cuts, tears, abrasians or other damage or irritation prior to attaching the LifePath-C system, Do not use any third party power supplies or charging adapters to charge the Wearable Medical Monitor, Battery Dock Charging Adapter, or Smartphone. Do not twist or tangle the Cable Harness cables, Battery Dock Charging Adapter cable, or Smartphone Charger cable. Do not re-use exhaustable components such as Adhesive Patches, Alcohol Swabs, Adhesive Remover Wipes, or ECG Electrodes. Discard them after use. Only use provided accessories and exhaustible components with the LifePath-C system. If your facility requires additional consumables or replacement parts, contact, Elastic Care as soon as possible. Do not engage In any water-based activities while attached to the LifePath-C system, Do not connect or use a Wearable Medical Monitor and Cable Harness on more than one patient at a time. Do not connect or use more than one Wearable Medical Monitor and Cable Harness to a patient 2023/07 www.elasticcare.com Page3 2 Symbols symbol Title and Description Caution VAN Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself. mE Consult Instructions for Use Indicates the need for the user to consult the instructions for use. Manufacturer Indicates the medical device manufacturer FCC Marking FCC marking indicates the electronic device, which sold in the United States, is certified and the electromagnetic interference from the device is under the limits that are approved by Federal Communications Commission Prescription Device Federal law restricts the device to sale by or on the order of a licensed practitioner or therapist. LifePath-C = Clinical Instructions for Use Standard Title & Reference ISO 15223-1-2016/ Medical Devices symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.4.4 ISO 15223-1-2016 / Medical Devices -

Symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.43 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.11 Federal Communications Commission Prescription Devices Standard Reference: 21CFR 801.109 Page 4 www.elasticcare.com Ol 2023/01/17 LifePath - C 2 Symbols symbol SN LOT REF a o1 2023/01/17 Title and Description Serial Number Indicates the manufacturer's serial number so that a specific medical device can be identified Batch Code Indicates the manufacturer's batch code so that the batch or lot can be identified Catalogue Number Indicates the manufacturer's catalogue number so that the medical device can be identified. Patient Number Indicates a unique number associated with an individual patient. Non-Sterile Indicates a medical device that has not been subjected to a sterilization process, Recycle: Electronic Equipment Do not throw in trash, www.elasticcare.com Use Clinical Instructions Standard Title & Reference ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.1.7 1SO 15223-1-2016 / Medical Devices -

Symbols to be used with medical device labels, labelling, and information to be supplied, Standard Reference: 51.5 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and information to be supplied. Standard Reference: 5.1.6 ISO 15223-1-2016 / Medical Devices symbols to be used with medical device labels, labelling, and Information to be supplied, Standard Reference: 5.7.1 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied, Standard Reference: 5.2.7 BS EN 50419 Marking of Electrical and Electronic Equipment in accordance with Article 11(2) of Directive 2002/96/EC (WEEE). Page 5 2 Symbols Symbol Title and Description Temperature Limit Indicates the temperature limits to which the medial device can be safely exposed Humidity Limit

(%) Indicates the range of humidity to which the medical device can be safely exposed Atmospheric Pressure Limit

@-<) Indicates the range of atmospheric Pressure to which the medical device can be safely exposed, ile, handle with care 8 Indicates a medical device that can be broken or damaged if not handled carefully. Do not use if package is damaged Indicates a medical device that should not be used if the package has been, damaged or opened. t t This way up To indicate correct upright position of the transport package LifePath - C Clinical Instructions for Use Standard Title & Reference ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.3.7 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.3.8 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.3.9 ISO 15223-1-2016 / Medical Devices symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 53.1 ISO 15223-1-2016 / Medical Devices -

symbols to be used with medical device labels, labelling, and Information to be supplied. Standard Reference: 5.2.8 ISO 7000: 2019 / Graphical symbols for use Standard Reference: No. 0623 Page 6 www.elasticcare.com Ol 2023/01/17 or ES saan ae LifePath-C = Clinical Instructions for Use 2 Symbols symbol O IP22 2023/0117 Title and Description Class I Equipment Identifies equipment meeting the safety requirements specified for Class It equipment according to IEC 61140. Keep Dry Indicates a medical device that needs to be protected from moisture. Do Not Re-use Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. IP Classification Wearable Medical Monitor with battery pack and cable harness installed are protected from ingress of finger sized objects and from dripping water it at an angle of 15 degrees from normal device orientation, gress Keep Away from Sunlight Indicates a medical device that needs protection from light sources. www.elasticcare.com Standard Title & Reference IEC 60417: 2002 DB / Graphical symbols for use on equipment. Standard Reference: 5172 ISO 15223-1-2016 / Medical Devices -

Symbols to be used with medical device labels, labelling, and information to be supplied, Standard Reference: 5.3.4 ISO 15223-1-2016 / Medical Devices symbols to be used with medical device labels, labelling, and information to be supplied. Standard Reference: 5.4.2 IP Classification Standard ISO 15223-1-2012 / Medical Devices symbols to be used with medical device labels, labelling, and Information to be supplied, Standard Reference: 5.3.2 Page 7 Ee ease LifePath -C Clin 3 LifePath-C Symbols symbol Title and Description Instructions for Use Wearable Medical Monitor Wearable Medical Monitor symbol. Battery Status Wearable Medical Monitor battery status symbol. Smartphone symbol for included Smartphone. Elastic Care Mobile App Elastic Care Mobile Application symbol ie Wireless Network symbol, Cloud/Server Cloud/Internet or Data server/center symbol symbol, Lane COS LTE (Long-Term Evolution) broadband symbol. LifePath-c ECG Cable/Leads LifePath-C ECG Cable and/or leads symbol. Calibration Calibration symbol.

\ Monitoring Symbol Symbol to indicate current state is Monitoring. Wearable Medical Monitor is collecting data and transmitting it to the Smartphone. Note: this is NOT an ECG waveform, Page 8 www.elasticcare.com Ol 2023/01/17 LifePath -C = Clinical Instructions for Use 3 LifePath-C Symbols symbol

Title and Description Bluetooth Symbol Symbol to indicate Bluetooth connectio.n Start Monitoring Button Starts monitoring when tapped. Also takes a measurement if the current device is a third-party device. Searching for Wearable Medical Monitor Symbol Indicates Smartphone is searching for the Wearable Medical Monitor with which It is paired, Connecting to Wearable Medical Monitor Symbol Indicates Smartphone is connecting to paired Wearable Medical Monitor. Connected to Wearable Medical Monitor Symbol Indicates Smartphone has successfully connected to paired Wearble Medical Monitor. Pause Monitoring Button Pauses monitoring when tapped, Data collection by Wearable Medical Monitor and transmission to Smartphone will stop. Stop Measurement Halts the measurement being taken by a third-party device. Not Monitor 19 / Not Collecting Data Symbol Symbol to indicate that the current state is Not Monitoring. Wearable Medical Monitor or current third-party device is not collecting data Not Connected to Wearable Medical Monitor Indicates that Smartphone is not connected to the Wearable Medical Monitor. Appears, when initiating a connection or if the Bluetooth connection has been severed while monitoring o1 2023/01/17 www.elasticcare.com Page 9 3 LifePath-C Symbols symbol Title and Description LifePath-C Clin Instructions for Use Bluetooth ignal Strength Te) Indicates strength of Bluetooth connection between Smartphone and Wearable Medical Monitor. More solid dots indicates stronger connection. Time Remaining Countdown

Counts down the time remaining in the LifePath-C monitoring campaign. D- Days. H- hours. M- Minutes. S- Seconds. Hardware Error Indicates a hardware error with the LifePath-C system. Contact Elastic Care for immediate assistance. Error Detected Appears alongside descriptions of errors detected during the LifePath-C monitoring campaign. Error Corrected OR Pre-Launch Check Stage Successful 9 @ @

Appears when a Pre-Launch Check stage has been successfully completed. Also appears when errors during the monitoring campaign are corrected. Page 10 www.elasticcare.com O1 2023/01/17 Ee Saanie LifePath -C Clinical Instructions for Use 4 Standards ANSI AAMI ES60601-1:2005/(R)2012 and Al:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part I: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) ANSI/AAMI/IEC 60601-1-2:2014 Medical electrical equipment ~ Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests ANSI AAMI HAGO6O1-1 1:2015 Medical Electrical Equipment - Part 11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equiprnent and medical cal equipment and medical electrical systems used in the home healthcare environment (IEC 12015 MOD) elect 60601 ANSI AAMI IEC 62366-1:2015 Medical devices - Part |: Application of usability engineering to medical devices ANSI AAMI IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes [Including Amendment | (2016]]

ANSI AAMI IEC 60601-2-47:2012(R)2016 Medical electrical equipment Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity O1 2023/01/17 www.elasticcare.com Page ll Ee magne LifePath - Clinical Instructions for Use 4 Standards ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of rnedical devices - Part 10: Tests for irritation and skin sensitization ANSI/AAMI/ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical devices - Applications of risk management to medical devices ISO 80601-2-56:2017(E) Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ISO 80601-2-56:2017/Amd.1:2018(E) Medical electrical equipment - Part 2 performance of clinical thermometers for body ternperature measurement [Including: Amendment 1 (2018)]

56: Particular requirernents for basic safety and essential ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems ANSI AAMI ISO 15223-1:2016 Medical devicesSymbols to be used with medical device labels, labelling and information to be suppliedPart I: General requirements, ANSI AAMI ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice [Including:

Technical Corrigendum 1 (2011) ANSI AAMI ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices UN38.3 Transport of Dangerous Goods, Manual of Test and Criteria outlines, Fifth edition with Amendment 1 and Amendment 2 Page 12 www.elasticcare.com ol 2023/01/17 Ee mnie LifePath -C Clinical Instructions for Use 4 Standards IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety require ments for portable sealed secondary cells, and for batteries made from ther, for use in portable applications - Part 2: Lithium systems Radio testing as per FCC 15.247 / RSS 24 using ANSI C63.10:2013 American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices ANSI AAMI EC12:2000/(R)2015 Disposable ECG electrodes IEC/TR 80001-2-8:2016 Application of risk management for IT-networks incorporating medical devices Part 2-8: Applica tion guidance Guidance on standards for establishing the security capabilities identified in IEC 80001-2.2 IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Part 2-2: Guidance for the communication of medical device security needs, risks and controls. ISO 7000 Sixth edition 2019-07 Graphical symbols for use on equipment - Registered symbols IEC 60417:2002 DB Graphical symbols for use on equipment WEEE Directive 2002/96/EC Ol 2023/0/17 www.elasticcare.com Page 13 LifePath -C Clinical Instructions for Use 5 Introduction 5.1 Intended Use The LifePath-C (LPC) Monitoring System consists of the LifePath-C wearable device and a mobile application that are intended for prescription use by healthcare professionals in order to collect quantitative biometric data from the thoracic region of adult patients. LPC captures ECG (6/12 Lead), Heart Rate, Skin Temperature, Respiration Rate and Activity data for ambulatory and non-ambulatory patients as an adjunct to other methods to assess and record biometric data. The device is intended to be used in professional healthcare and home environments. The LPC mobile application can be used as a platform for the collection and reporting of biometric data from low risk bluetooth-enabled class | and class II blood pressure meters, glucometers and pulse oximeter medical devices that are cleared for sale in USA by the FDA. These devices are to be used only as intended by the respective manufacturers; the labelling, functionalities and instructions are to be followed as stated by the respective device manufactur-

ers. Furthermore, these devices are to be used as indicated by a qualified medical practitioner, as applicable. Finally, the collected data is not altered or interpreted in any fashion, and is presented on an as-is basis. The LPC mobile application displays the relevant notices and disclaimers. 5.2 Intended user knowledge base LifePath-C (LPC) is to be prescribed by a Physician and attached / adminis-

tered by a Physician or equivalent or certified Nurse or equivalent in a health-

care setup. Page 14 www.elasticcare.com ol 2023/0/17 Ee ELAstic LifePath -C Clinic al Instructions for Use 5.3. Contraindication The use of LifePath-C is contraindicated for the following;

@ _ Patients/individuals less than 22 years of age.

@ Patients requiring attended, in-hospital monitoring for life-threatening arrhythmias. Patients/individuals with any active implantable devices, Patients during pregnancy. Patients/individuals with broken or fragile skin on the torso. Patients/individuals who are allergic to acrylic, hydro gel, or silicone A adhesives 5.4 Overview E _ LifePath-c Platform Overview Diagram Secure Elastic Care smartphone Servers Wearable Medical Monitor (WMM) Autornatically Generated Reports Ol 2023/0/17 www.elasticcare.com Page 15 Ee re LifePath -C Clinical Instructions for U 6 Hardware Overview Wearable Medical Monitor

& Cable Harness (attached) Wearable Medical Monitor

(with battery inserted) Cable Harness Page 16 www.elasticcare.com 01 2023/01/17 LifePath -C Clinical Instructions for Us 6 Hardware Overview Wearable Medical Monitor Wearable Medical Monitor Battery (removable) Top/Front View Info/Status Indicator LED light 6/12 Lead Cable Harness port Diagnostic Port

(DO NOT remove) Data transmission LED light Temperature sensor Attachment surface for Adhesive Patch o1 2023/01/17 www.elasticcare.com Page 17 LifePath -C Clinical Instructions for Us 6 Hardware Overview Cable Harness ECG Lead Label Snaps ECG Electrode

(x4 or x10) snap contact Cable Harness Lead wires

(x4 or x10) Harness Connector Cable Harness connector male Right Side port Up indicator dot/grip. Page 18 www.elasticcare.com O1 2023/01/17 o LifePath -C Clinical Instructions for Use 7 Package Contents OB, 2023/01/17 Wearable Medical Monitor (WMM) This unit is attached to the patient's chest using the Adhesive Patch x find in Wearable Medical Monitor Battery Battery to be inserted into the Wearable Medical Monitor. Batteries are charged using the Wearable Medical Monitor Battery Dock. x2 findin E Wearable Medical Monitor Battery Dock Charges the Wearable Medical Monitor's battery when the battery is inserted x find in E]

Battery Dock Charging Adapter Connects the Wearable Medical Monitor Battery Dock to a wall power outlet. x 1 findin EY Adhesive Patches Adouble sided adhesive patch to affix the Wear-

able Medical Monitor to the patient's chest. Tpatch/day + 3 extra x10 find in www.elasticcare.com Page 19 LifePath -C Clinical Instructions for Us 7 Package Contents Wearable Medical Monitor Harness

(12-Lead) 10-wire ECG cable harness. x find in BJ Wearable Medical Monitor Harness

(6-Lead) 4-wire ECG cable harness. x find in By ECG Electrodes 12-lead configuration - 10 electrodes/day + extra 6-Lead configuration - 4 electrodes/day + extra x 80 find in By}

Smartphone A pre-configured smartphone, pre-loaded with the Elastic Care application used to interface with LifePath-c. x1 find in EY

> Smartphone Charger Charges the Smartphone when connected to a wall power outlet. x1 find in EY Page 20 www.elasticcare.com O1 2023/01/17 Ee Esme LifePath -C Clinical structions for Use 7 Package Contents Alcohol Swabs

| Alcohol Swabs |

ieee t To prepare the patient's skin prior to attaching i : LifePath-c. z x10 find in By Tey Adhesive Remover Wipes

: To remove adhesive residue from the Wearable LTA] Arest | 7

: nemo : Medical Monitor and ECG lead cables. S X10 fingin BY Documents Quick Start One Pager Instruction Document Folder Clinical Instructions for Use This document. LifePath-C Clinical Instructions For Use. Patient Instructions To be handed to and explained to the patient after LifePath-C has been attached and monitoring has begun. Contains a list of precautions, warnings and instructions for use. Return Instruction Folder Return Instructions Shipping Air Waybill Shipping Pouch ol 2023/0/17 www.elasticcare.com Page 21 LifePath -C Clinical Instructions 8 Getting Started With LifePath-C The LifePath-C Monitoring System consists of the LifePath-C Hardware and Elastic Care Mobile Application, which has been pre-loaded onto the included Smartphone. The Elastic Care Mobile Application is required to setup, configure, and operate the LifePath-C Monitoring System. It requires personnel to log in using their Elastic Care Login Credentials for that facility. 8.1 Receiving Elastic Care Login Credentials During the sign up process for LifePath-C, your healthcare administrator (or personnel responsible for ordering LifePath-C packages) will be asked for the names and email addresses of the physicians and nurses within the health care facility who will be prescribing LifePath-C to patients. Unique login credentials (usernames and passwords) for the Elastic Care Mobile Application are sent to these personnel via the email addresses provided. If your facility does not receive login credentials after signing up, contact Elastic Care support as soon as possible Elastic Care Elastic Care Login Credentials Mobile Application A Username

* Password ;

Page 22 www.elasticcare.com ol 2023/01/17 ES smn LifePath -C Clinical Instructions for Use 8.2 Preparation Prior to setting up a LifePath-C monitoring campaign, ensure that you have the following:

1. The physician's/nurse's email addresses provided by your healthcare facility when signing up for LifePath-C. This will contain their login credentials for the Elastic Care Mobile Application:

2. Access toa LifePath-C package. 3. The patient, for whom LifePath-C is being prescribed, is present. 4. Access to a wireless network and an internet connection. 5. The prescribing physician's requirements for monitoring

(number of leads, monitoring duration, report delivery frequency) ol 2023/0/17 www.elasticcare.com Page 23 Ee magne LifePath -C Clinic Instructions for Use 9 Setup The following section outlines the setup, configuration, assembly, and attachment of the LifePath-C Monitoring System to a patient. Please carefully read all contraindications before affixing LifePath-C to a patient. The unboxing process is integrated into the setup and assembly of the LifePath-C system. Please carefully read each step and ensure it has been performed correctly before advancing further. The various components of the LifePath-C system are separated into sections, each covered with a flap (4 flaps, marked A, B, C, and D). Do not open a flap and/or atternpt to assemble the components until being instructed to in the LifePath-C setup instructions. Unboxing Only open Flaps when instructed on the Elastic Care Mobile Application Page 24 www.elasticcare.com Ol 2023/0/17 Ee oye LifePath -C Clinical Instructions for Us LifePath-c eae Setup Instructions Smartphone and turn it ON Press and hold the side button on the phone until the screen turns on.

=> * You will be required to use the Elastic Care mobile app to complete this setup. ol 2023/0/17 www.elasticcare.com Page 25 res LifePath-c nical Instructions for Use 9.2 Logging into the Elastic Care Mobile Application After turning the Smartphone ON, you will be guided through the setup of the LifePath-C system. Follow the on screen instructions. Setup and operation of the Lifepath-

system requires a wireless internet connection. Please ensure you have access to a reliable wireless network before proceeding. 1: Read and acknowledge warnings and cautions Warning: to be used by licensed healthcare providers only. This screen will show a list of warnings, cautions, and contraindications for use of the LifePath-C monitoring system. Tap the

[ Acknowledge] button only if you are a licensed healthcare provider and have read these warnings. Next Screen: Connect to a Wi-Fi network

: Connect to a Wi-Fi network:

If the Smartphone is not connected to a Wi-Fi network, you will be prompted Lo connect to one. Tap the [Proceed] button on the popup to be taken to the smartphone's Wi-Fi settings. Select a network from the list of available networks and enter its password to connect. Once successful, you will be taken back to the Elastic Care Mobile Application. Next Screen: End User License Agreement (EULA)

: Read and accept End User License Agreement Read the Elastic Care End User License Agreement. Scroll down to the bottom of the screen and tap the [I Accept] button if you agree to the terms. Next Section: Patient Setup 4: Log in to the Elastic Care Mobile Application ifyou are a physician or nurse, use the login credentials for the Elastic Care Mobile Application sent to you by Elastic Care. Enter your username and password and tap [Login] to login. Next Section: Patient Setup 9.3 Patient Onboarding After logging in, you may begin setup of a patient's monitoring campaign. However, patients must be registered with LifePath-C in order to assign monitoring campaigns to them. The following outlines this procedure:

Page 26 www.elasticcare.com Ol 2023/01/17 LifePath -C Clinical Instructions for Use 9.3 Patient Onboarding (Contd.) 1: Select an Institute You will now be presented with a greeting (Fx Welcome, Dr. Stephanie Smith), and a list of healthcare institutes you're associated to will appear underneath. Tap the name of the institute under which you will be starting a monitoring campaign Next Screen: Enter Patient ID

* If your healthcare facility has previously registered this patient with LifePath-C, proceed to 2B after selecting an institute*

2A; Enter Patient ID - Create a New Patient 1: If the patient has not been registered under your healthcare facility as a LifePath-C patient, enter a Patient ID (the ID your institution Uses to track a patient) and associated Allas in the indicated fields, then tap the [+ Add a New Patient] button to create a Patient ID. 2: A popup window will appear titled Confirm Patient 1D with the Patient ID you've entered displayed below it. If this is correct, tap the [Next] button. Ifit is not correct, or you need to change it, tap the [Cancel] button to go back and re-enter the information, 3: A popup confirming that the Patient ID was successfully created will be displayed. Tap the

[Proceed to Configuration] button to begin configuring the monitoring campaign. Next Section: Configuration 2B: Enter Patient ID - Existing LifePath-C Patients of your healthcare facility:

your healthcare facility has previously registered the current patient with LifePath, enter the Patient ID used in your healthcare facility to identify them in the text entry field and tap the [Submit] button. 2: A popup window will appear titled Confirm Patient /D' with the Patient ID you've entered displayed below it. If this is correct, tap the [Next] button. If it isnot corract, or you need to change it, tap the [Cancel] button to go back and re-enter the information, 3. IF the Patient ID was successfully found, a popup titled Success! Patient Found with the Patient ID shown below, will be displayed. Tap the [Proceed to Configuration] button to begin configuring the monitoring campaign Note: If the Patient ID you've entered was not found, a popup will be displayed with option to enter the details Next Section: Configuration o1 2023/01/17 www.elasticcare.com Page 27 re LifePath-c nical Instructions for Use 9.4 Campaign Configuration After a new LifePath-C patient has been created or an existing LifePath-C patient has been entered, the screens which follow will take you through the configuration of the LifePath-C monitoring campaign. Confirm the prescribing physician's requirements for the campaign before proceeding, as it cannot be modified after it has been configured The first configuration screen will require you to select the vitals to be monitored and monitoring campaign duration:

Step 1: Select vitals to be monitored Select between a 6-Lead or 12-Lead ECG configuration. A 6-Lead configuration consist of LA, RA, LL, RL + Respiration Rate, Skin Temperature, and Activity/Posture. |:

consist of LA, RA, LL, RL, and VI-V6 + Respiration Rate, Skin Temperature, and Activity/Posture. Lead configurations Tap the button with desired option. It will turn pink to indicate that it has been selected, Step 2: Select Monitoring Duration Monitoring campaigns can last from 1 to 7 days. Drag the slider on the screen to select the desired length of time. Tap the [Next] button to proceed to the next step, Next Screen: Report Delivery Frequency Step 3: Select Report Delivery Frequency PDF reports can be sent on an hourly, daily, or weekly basis to physicians and nurses via e-mail. Choose one of the three options. Report periods start when monitoring has been started, Tap the [Next] button Lo proceed to the next step Next Screen: Enter Physician Details Step 4: Enter Physician Details Enter the names and email addresses of the physician(s) who will receive reports for this monitoring campaign. You can add additional physicians or nurses who are also registered to Elastic Care under the same facility. Tap the [Next] button to proceed to the next step Next Screen: Scan Wearable Medical Monitor Page 28 www.elasticcare.com o1 2023/01/17 ol LifePath -C Clinical Instructions for Use 9.4. Campaign Configuration (Cont'd) Step 5: Scan Wearable Medical Monitor Open FlapfJand remove the Wearable Medical Monitor from its slot. Tap the [Sean Code]

button displayed on Smartphone. Next Screen: Camera Viewfinder Step 6: Place QR Code Inside Box The Smartphone camera viewfinder will be displayed. Place the QR code (Quick Response Code) sticker attached to the Wearable Medical Monitor inside the camera viewfinder box. When the camera successfully scans the QR Code, you will be automatically taken to the next screen. Sea 1a The QR code sticker ES Hi || willbe located as

S shown. An example QR Code You may need to adjust your distance so that the camera can focus. If you are having difficulty, tap the [Enter Serial Number] button to manually enter the Wearable Medical Monitor serial number Next Screen: Scan Successful Step 6: Scan Successful Confirmation The next screen will confirm the successful scan of the Wearable Medical Monitor and display its serial number. Next Screen: Review Summary Step 7: Review Summary Review the configuration you've selected on this Surmmary screen. If modifications need to be made, tap the [Back] button to go back to the desired step and make the changes. If you are satisfied with the configuration, tap the [Proceed to Setup] button to complete the order configuration and begin the LifePath-C Setup. 2023/0V17 www.elasticcare.com Page 29 LifePath -C Clinical Instructions for Us 9.5 Device and Patient Setup Follow steps 2 through 13 to ensure proper setup and attachment of the LifePath-C system to your patient. Do not attempt to skip steps or perform any tasks without first carefully reviewing the provided instructions.

Failure to do so may result in incorrect attachment and/or compromised signal quality. Page 30 www.elasticcare.com O1 2023/01/17 Step 2 Lets get started. Battery Dock x1 Battery Dock Charging Adapter x1 ol 2023/01/17 Wearable Medical Monitor Battery LifePath -C Clinical Instructions for Us Step 3 Charging Charge Wearable Medical Monitor Battery. x2 Red

- charging Green

- Fully charged www.elasticcare.com Page 31 Wearable Medical Agnes Monitor ee x1 x10 Page 32 www.elasticcare.com LifePath -C Clinical Instructions for U Step 5 Remove fully charged battery and slide into Wearable Medical Monitor. Green 01 2023/01/17 Ee aa LifePath -C Clinical Instructions for Us Step 6 Step 7 Peel, align, and attach. a0, Open /D|

ECG Electrodes x 80 ol 2023/0/17 www.elasticcare.com Page 33 Ee ene LifePath -C Clinical Instructions for Us Step 8 Step 9 Select harness, snap electrodes, Patient and insert harness. <

Preparation Shave and clean patient's torso

*Note- do not re-use alcohol swabs. Discard after each use Page 34 www.elasticcare.com Ol 2023/0/17 Step 10 Attaching Flip, peel backing, and attach to patient's sternum,

*Note- do not re-use adhesive patch. Discard after each use ol 2023/0/17 LifePath -C Clinic Instructions for Use Step T1 (12-Lead) Attaching One at a time, peel electrodes and attach to the patient's torso as shown.

*Note- do not re-use electrodes. Discard after each use. www.elasticcare.com Page 35 Ee Ease LifePath -C Clinical Instructions for Us Step Tl (6-Lead) Step 12 Attaching Define One at a time, peel electrodes and attach to the patient's torso Thresholds as shown. Define upper and lower thresholds for Heart Rate, Respiration Rate, and Skin Temperature. Reports show when these have been breached.

*This step must be performed during the setup process in the Elastic Care App. Heart Rate lower upper threshold threshold RL Resp. Rate Skin Temp. 200 swipe to advance

* You must input values for all three parameters before proceeding. Page 36 www.elasticcare.com Ol 2023/01/17 Ee re LifePath -C | Clinical Instructions for Us Step 13 Handover Fill your contact information on the Patient Instruction Card (in white folder). Review it with the patient. Hand over Patient Instruction Card to the patient.

=) * In order to proceed to the LifePath-C Dashboard, you must tap the Next button. Setup Complete. ea ol 2023/0/17 www.lasticcare.com Page 37 10 Operation LifePath - C Clinical Instructions for Use This section will detail the operation of LifePath-C with the Elastic Care mobile application. Please ensure the following;

1. Setup has been successfully completed and LifePath-C has been affixed to the patient 2. Thresholds have been set for the various biometric parameters collected during the monitoring campaign (Ex: Heart Rate, Respiration Rate, Skin Temperature) 3. You have reviewed the Patient Instruction Card with the patient and handed it over to them along with the included Smartphone. 10.1 Operating Requirements

& smartphone is connected to a Wi-Fi network with an Internet connection or have an LTE/cellular data connection. Smartphone is turned ON Bluetooth on the Wearable Medical Monitor Battery fully charged prior to start of monitoring A MAX distance of 1.5m is maintained between the Wearable Medical Monitor and the Smartphone. The Smartphone is LOCKED when not in use Smartphone battery charged and/or plugged into a power source during monitoring. After completing the LifePath-C Setup Procedure, you will be taken to the LifePath-C Dashboard. This screen will facillitate operation of LifePath-C. Page 38 www.elasticcare.com Ol 2023/01/17 LifePath -C Clinical Instructions for Use 10.2 Elastic Care Mobile Application Overview This sub-section will outline the operation and use of the Elastic Care Mobile Application, which is pre-installed on the included Smartphone. The Smartphone and Elastic Care Mobile Application perform several primary functions:

1. Receive all biometric data from a paired Wearable Medical Monitor and third-party devices, and transmit them, in real-time, to Elastic Care's secure servers via Wi-Fi or an LTE connection. 2. Provide an interface for creating, configuring, and controlling a LifePath-C monitoring campaign. Below are the additonal functions of the mobile application Startingstopping LifePath-C monitoring Pairing a Wearable Medical Monitor to the Smartphone Pairing and controlling approved third party devices and where applicable, displaying collected biometric data Patient ID creation (see section Getting Started with LifePath-C The viewing and management of notifications and alerts Viewing setup and onboarding instructions of LifePath-C and third-party devices Displaying the time remaining of monitoring campaign Displaying the hardware status, battery status and bluetooth signal strength of a paired Wearable Medical Monitor, and other connected third-party devices. o1 2023/01/17 www.elasticcare.com Page 39 LifePath -C Clinical Instructions for Us 10.2 Elastic Care Mobile Application Overview LifePath-C Interface Overview lll I Dashboard

@ wesvk John Smith LifePath-c Not Monitoring Press to start monitoring

*Dashboard section shown Page 40 www.elasticcare.com o1 Section Indicates which section you are currently viewing Menu access to Help, Troubleshooting, FAQ's, Version number, etc. Patient Information Patient ID and patient alias. Device Control Card Interface for controlling LifePath-C and other paired third-party devices. The Dashboard will display the Device Control Card for the Current Device Navigation Menu Tap to go to Notifications, Dashboard, Devices, and Settings 2023/01/17 o1 2023/01/17 LifePath -C Clinical Instrui 10.2 Elastic Care Mobile Application Overview Dashboard Overview After creating, configuring and setting up a LifePath-C monitoring campaign, you will be taken to the Dashboard. Here, you will be able to start and pause monitoring, and control paired third-party devices. The screen below shows the Device Control Card for the LifePath-C Wearable Medical Monitor. Dashboard

(Q) utepatn-c Not Monitoring Press to start monitoring Qyeeners John Smith -

www.elasticcare.com Device Type Displays the current device in use. Monitoring Controls Starts and pauses LifePath-C. monitoring When pressed, will start Monitoring. a When pressed, will pause Monitoring. Monitoring State Displays the current state of monitoring Time Remaining Displays how much time is remaining in the monitoring campaign Battery Wearable Medical Monitor battery percentage. Bluetooth Strength Bluetooth signal strength strona 2 good 00. lowMeak 900 notconnected Page 41 LifePath -C Clinical Instruction or Use 10.2 Elastic Care Mobile Application Overview Notifications Overview The Notifications page will display alerts pertaining to the LifePath-C device in use, and monitoring campaign. Notifications are split into two sub-catego-

ries; Logs and Alarms. Logs List of events for informative purposes only. Alarms Events which require action by the patient or healthcare provider. The red bubble in the navigation bar indicates the number of alarms that are pending The most recent alarm will also be displayed on the Dashboard as a popup with corrective actions to be performed. Once completed, the alarm popup will be automatically dismissed The red bubble indicator will revert back to clear when the Notifications button has been tapped and notifications have been viewed. Page 42 www.elasticcare.com ol 2023/01/17 Notifications Alarms erin a Low battery 207am Monitoring paused 10.02 pm. Bluetooth disconnected 28pm ap x @ 2 Notifications Dashboard Devices settings ol LifePath - C Clinical Instructions for Use 10.2 Elastic Care Mobile Application Overview Devices Overview The Devices section provides an overview of the connected devices. Every paired device will be represented by its own Device Card Current Device LifePath-c ex %

Not Monitoring <

Lead Configuration Moe: ehieeisae Lime ft @ &@ 7 2023/0V/17 www.elasticcare.com Add Devices Button Tap to add approved third-party devices to the monitorng campaign Current Device Label Tap device card to make it the current device. System Indicators Device (Wearable Medical Monitor or third-party device) battery and Bluetooth status. Monitoring State Displays the connected LifePath-Cs monitoring state. Lead Configuration Lead Configuration for the connected Wearable Medical Monitor. Can be either 12-Lead or 6-Lead. Device Information Device MAC ID and Firmware version. Page 43 LifePath -C Clinical Instructions 10.2 Elastic Care Mobile Application Overview Settings Overview Within the Settings section, Wi-Fi and LTE networks can be set up, connected to, and configured. Bluetooth and Server status can be viewed,

*Note* Always be connected to either a Fr LTE network to ensure data collected is transmitted to Elastic Care servers for processing. Settings Wi-Fi Settings Tap here to go into Wi-Fi Ds ry settings in order to connect to, ae 5 view, and configure available dopinect Wi-Fi networks. al ve | > LTE Settings Tap here to go into LTE data settings In ordentesetup ari LTE data connection. Carrier charges may apply.

% auetooth Connected- WMM92018 >

&> server Status Benriecte Bluetooth Status Bluetooth Status and

{software connected device ID. Tap to access Bluetooth settings. Log Out App Ver, 2.11 Server Status Displays Elastic Care server status.

= ~ Log Out

; ) vr @ Logs user out of the Notifications Dashboard Devices settings Elastic Care Mobile Application. You will need to re-enter credentials in order to log back in. Page 44 www.elasticcare.com ol 2023/0/17 Ee ease LifePath -C Clinica nstructic 10.2 Elastic Care Mobile Application Overview Menu Access to various resources, such as Setup Instructions, FAQ's, Trouble-shooting, and a digital version of these Clinical Instructions For Use can be accessed by tapping the Menu icon = from within the Dashboard

< Menu Setup Instructions FAQ's Troubleshooting User Manual Phone Email About Elastic Care Gp sc @o Notifications Dashboard Devices ol 2023/0/17 www.elasticcare.com Page 45 LifePath -C Clinical Instruc r Use 10.3 Starting Monitoring Starting Monitoring With a monitoring campaign configured and the Wearable Medical BoP enitoring Monitor attached to the patient, tap the ing. Start Monitoring button as shown in order to begin monitoring The Elastic Care Mobile Application will connect and pair with Wearable Medical Monitor. The monitoring controls will quickly display the connection progress.

=D eo Connecting Not Monitoring => Searching > Connecting =} Connected Not connected to smartphone looking Wearable Medical Connection Wearable Medical for paired Wearable Monitor found. established. Data now Monitor. Smartphone Medical Monitor. Connection being _being trasmitted from not receiving data established. Wearable Medical from Wearable Monitor to Smart Medical Monitor phone. Once connected, a Pre-Launch Check will begin to ensure all parts of the LifePath-C system are functioning correctly prior to the start of monitoring. Page 46 www.elasticcare.com ol 2023/01/17 10.4 Pre-Launch Check LifePath-c Pre-launch Check Hardware check Connectivity check Calibration and Signal Check LifePath -C Clinic I Instructions The Pre-Launch Check will be performed to ensure the correct attachment and functioning of the Wearable Medical Monitor, test wireless connections, check signal fidelity, and perform a calibration(*) prior to the monitoring beginning This check is done sequentially in stages. In order for the Pre-Launch Check to be successful and monitoring to begin, all three stages must be free of errors. Once successful, monitoring will commence, and you will be returned to the Dashboard The Pre-Launch check will occur every time monitoring starts or re-starts.

* Calibration refers to the LifePath-C system taking a collection of initial measurements to produce a patient's baseline vitals. Ol 2023/0/17 www.elasticcare.com Page 47 Ee magne LifePath -C Clinic Instructions for Use 10.4. Pre-Launch Check The Pre-Launch Check is split into three stages. Hardware check Checks all hardware functionalities required for normal operations:

Internal hardware, electrode connections, and cable harness. ga Checks for a valid Wi-Fi or LTE connection, we internet connection, Bluetooth connection and strength, and verifies status of Elastic Care servers. _f. Calibration and Calibrates the Wearable Medical Monitor signal Check and checks signal fidelity. During this stage, the patient will be instructed to remain still in a seated position for approximately 2 minutes. Successful stages of the Pre-Launch Check will be indicated by a green check mark symbol @ and will automatically advance to the next stage. Stages during which errors are encountered will be indicated by a red'x @ symbol and will require correction/troubleshooting before proceeding. Refer to the section of this manual titled Pre-Launch Check Errors for more information If a stage is free of errors, you will not be required to take any action. Page 48 www.elasticcare.com Ol 2023/0/17 Ee re LifePath -C Clinical Instructio 10.5 Successful Pre-Launch Check Lifepath- Lifepath-c Pre-launch Pre-launch Check: Check:

Successful Hardware check o Connectivity check 9 g o The patient Is now ready to be discharged Calibration and signal Check Once all three stages of the Pre-Launch check have been successfully completed, the LifePath-C system will be in a Monitoring state. Hand the Smartphone over to the patient and instruct them to keep it on, charged, and nearby during the monitoring campaign. Tap the *Go to Dashboard button shown to proceed to the Dashboard ol 2023/0/17 www.elasticcare.com Page 49 LifePath -C Clinical Instrt 10.6 Monitoring While monitoring, the Monitoring State will be 'Monitoring and the monitoring control will be a Pause Monitoring button. At this time, the Wearable Medical Monitor is continuously collecting biometric data with its various sensors (ECG, Respiration Rate, Skin Temperature, and Activity

/Posture) and transmitting it, in real-time, to the Smartphone via Bluetooth. This data is then transmitted, also in real-time, to Elastic Care's servers by the Smartphone via a Wi-Fi or an LTE connection. The monitoring campaign will begin the Dashboard = first time monitoring starts. |t will run for o1s283a0K the duration of time selected during the OMT EOI Campaign Configuration stage. Rey Lepathec The Wearable Medical Monitor will remain in a monitoring state unless The Wearable Medical Monitor battery is completely drained, or The Pause Monitoring button is tapped for The Scheduled Maintenance procedure Monitoring is started ress to pause monitoring The time remaining is displayed beside the Time Left label on the Device Control Card m @ @ Recommendation: Stay on the hs Dashboard ovens sattngs ~-- Dashboard screen It is recommended that the mobile application be kept on the Dashboard screen during the campaign, as notifications for problems encountered during the campaign, reminders to charge the Wearable Medical Monitor battery and scheduled maintenance, will be easily seen. Dashboard screen while ina monitoring state. Smartphone is receiving signals frorn Wearable Medical Monitor. Page 50 www.elasticcare.com ol 2023/01/17

o1 LifePath -C Clinical Instructions Use 10.6 Monitoring The LifePath-C system does not require any constant supervision or interven-

tion by the physician/nurse or patient when monitoring. It is intended to unobtrusively collect data while the patient carries on with their daily activities, except those which are contraindicated by use of the LifePath-C system, such as showering or other water related activities. It is important, that while the LifePath-C system is in a monitoring state, the patient follows instructions and heeds all warnings and cautions found on the Patient Instruction Card. As well, they should be instructed to contact the healthcare facility if any discomfort or other problems arise while being monitored 10.7 Monitoring Campaign Procedure The following outlines the general procedures during a monitoring campaign:

1 Nurse at healthcare facility sets up monitoring campaign and attaches LifePath-C to the patient. 2. Monitoring starts. Patient Information Card, warnings, and instructions reviewed with Patient. 3. Patient is discharged from healthcare facility with LifePath-C and Smartphone and returns to their daily activities, following instructions for safe use. 4 Maintenance reminder given approximately 24 hours after monitoring, starts. Patient contacts healthcare facility for scheduled maintenance. 5. Monitoring paused, Maintenance procedure performed by nurse. 6. Monitoring resumed, Patient is discharged and returns home. 7. Patient returns for all scheduled maintenance during campaign, 8. Monitoring campaign ends. LifePath-C system removed from patient

* Refer to sections titled Maintenance and Pausing Monitoring for more information on these topics. 2023/07 www.elasticcare.com Page 51 Ee ELASTIC LifePath -C Clinical Instructions r Use 10.8 Pausing Monitoring You can pause monitoring by tapping the Pause Monitoring button. The Monitoring State will revert to Not Monitoring Monitoring and the Wearable monitoring Medical Monitor will halt signal collection, as well as data transmission to the Smartphone. The LifePath-C system will remain in the Not Monitoring state until the Start Monitoring button is tapped again and monitoring resumes. Important! The Campaign timer will continue to elapse while the monitoring has been paused. When to Pause Monitoring Monitoring should always be paused prior to any battery swaps, removal of the Wearable Medical Monitor from the patient, maintenance, cleaning, or disconnection of the cable harness or ECG leads. Failure to pause monitoring may result in loss of data or compromised signal quality, 10.9 Resuming Monitoring Monitoring can be resumed by tapping the Start Monitoring button. When tapped, the Smartphone will reconnect to the Wearable Medical Monitor, run through the Pre-Launch Check, and upon successful completion, resume monitoring Rais Tapping the Start Monitoring button will resume monitoring. Page 52 www.elasticcare.com Ol 2023/01/17 Ee magne LifePath -C Clinic Instructic 10.10 Monitoring Errors Errors or problems encountered while monitoring will be identified and displayed as popups on the Dashboard. The popups will;

1. Instruct the patient to contact their healthcare provider (for Cable Harness disconnected, ECG Lead disconnected, and low battery warning popups) 2. Provide an image and description of the error. 3. Provide instructions to correct the error. Itis important that the patient does not attempt to perform the corrective actions themselves in cases where they are instructed to contact their healthcare provider. The nurse/healthcare provider must perform these tasks. Popups will persist until the error has been corrected. If a popup is dismissed and the error remains un-corrected, it will re-appear in a few minutes. Vibration and LED Alerts LifePath-C also provides tactile and visual feedback to the patient when errors are encountered. The Wearable Medical Monitor will vibrate and the Info/Status Indicator LED will blink. See the section titled Wearable Medical Monitor Alerts for more information. Ol 2023/0/17 www.elasticcare.com Page 53 10.10 Monitoring Errors Contact your healthcare provider P Ecc Cable and Leads @

cable Harness ts not connected. Insert hamess as shown. ECG Cable Harness Disconnected The ECG Cable harness is not connected to the Wearable Medical Monitor. Solution:

Insert the Cable Harness connector into the port as shown. LifePath -C Clinical Instructic Contact your healthcare provider P Ec cable and Leads @

One or more of the ECG leads are not connected Attach as shown below. ECG Leads Disconnected One or more of the ECG leads are disconnected or improperly attached. Solution:

Ensure all leads are attached as described in the diagram above. Ensure each electrode is in contact with the patient's skin. Page 54 www.elasticcare.com Ol 2023/0/17 or 2023/01/17 10.10 Monitoring Errors Wearable Medical Monitor Battery Low Please contact your healthcare provider as soon as possible. press the Pause Monitoring, button before swapping batteries. current battery a k Wearable Medical Monitor Battery Low The Wearable Medical Monitor Battery is low. Solution:

Press the pause monitoring button and insert a fully charged Wearable Medical Monitor battery. Once replaced, resume monitoring. See the section titled swapping Batteries for more informa. tion, LifePath-C Clin www.elasticcare.com structions

% Bluetooth sional @

There Isa weak signal between the Wearable Medical Monitor and:

this Smartphone. Please move the two closer together to Improve the signal strength Weak Bluetooth Signal Weak Bluetooth signal between the Wearable Medical Monitor and smartphone. Soluti Move the two devices closer together until the signal strength improves. Page 55 Elastic LifePath -C Clinical Inst uctions for Us 10.10 Monitoring Errors

(Disconnected @

@ wiiconnection @

The Wearable Medical Monitor ee astbincna whee carts hhas been dlsconnected from Mb af network aninteinet this smarphone onneetionssrequited perform one or more ofthe rap Proceed to connect to a networ following steps to reconnect: peas ie oe 1. check the battery status and insert a fully recharged battery If necossary 2. Return to within a few feet of the smartphone Wearable Medical Monitor Disconnected No Wi-Fi Connection The Wearable Medical Monitor has The Smartphone is not connected to a been disconnected from the Smart Wi-Fi network phone Solution: Solution:

Check the battery status of the Wearable Medical Monitor and Smartphones Wi-Fi settings and replace with a fully charged battery if connect to an available wireless necessary. Or, return to within a few network feet of the Smartphone. Tap Proceed to access the Page 56 www.elasticcare.com ol 2023/01/17 Ee ore LifePath-C Clin Js 10.10 Monitoring Errors ED internet connection @ Smartphone Battery Low There doesnt seem to be an internet connection. Please check your modem andjor router settings, ddan are dad eondetpnesoes, T*feady wcheck theconnection. current batterytevel, CB No Internet Connection Smartphone Battery Low There is no internet connection. The Smartphone battery is low Solution: Solution:

Check your modem and/or router Plug the Smartphone into a power settings and retry connecting. outlet using the included Smartphone charger to charge. ol 2023/0/17 www.elasticcare.com Page 57 LifePath -C Clinical Instructions for Use Tl Connectivity 11.1 Bluetooth Connection During monitoring, the Wearable Medical Monitor collects biometric data and transmits it over Bluetooth, in real time, to the Smartphone with which it is paired When the Start Monitoring button is tapped, the Bluetooth connection between the Wearable Medical Monitor and Smartphone is established. Once connected, the Smartphone will be able to:

1. Control the monitoring state (Start/Pause monitoring) 2. Receive blometric data collected by the Wearable Medical Monitor 3. Receive the hardware status of the Wearable Medical Monitor, Wearable Medical Monitor Battery, Cable Harness and ECG leads 4 Receive alerts, alarms, and error messages from the Wearable Medical Monitor, such as those for disconnected ECG leads and low battery It is important to maintain the Bluetooth connection between the Wearable Medical Monitor and Smartphone for this data transmission to occur. This is accomplished by ensuring that the patient and Smartphone are at a maximum distance of 1.5 m of eachother. When monitoring is paused and the monitoring state reverts to Not Monitoring the Bluetooth connection is suspended. Not Monitoring Monitoring No Bluetooth Connection between Smartphone and Wearable Medical Wearable Medical Monitor and Smart- Monitor connected via Bluetooth phone. Smartphone can control Wearable Medical No Data being transmitted from Wearable Manitenand faenitoring erate:

Madical Monitor to srnartphone, Data being transmitted from Wearable LED light on Wearable Medical Monitor Medical Monitor to Smartphone NGT-binKiAg BLUE LED light on Wearable Medical Monitor will blink BLUE Page 58 www.elasticcare.com o1 2023/01/17 Ee

=A LifePath -C Clinical Instructions for Use 11.2 Bluetooth Signal Strength If the Bluetooth signal between the Wearable Medical Monitor and the Smartphone weakens while monitoring (either due to the maximum allowable distance between the two being exceeded, or electromagnetic interference), a popup will be displayed on the Dashboard, alerting the user to the weakened Bluetooth signal strength and instructions to move closer.

Bluetooth signal strength is indicated by 3 blue dots. It is always displayed on TMiicarable medical Mentor ana the Device Control Card on the this Smartphone Dashboard. It is also displayed on the vidi ac it serena ate \Weak Bluetooth Signal popup seen

% Bluetooth signal @

Hollow dots (outlines) indicate a na weakened signal. Two out of three dots that are hollow indicate a very weak Three solid dots indicate a strong Ss signal.

- foKe) e weak Weak Bluetooth Signal popup displayed on top of Dashboard. The popup will dismiss automatically when signal strength improves, o1 2023/01/17 www.elasticcare.com Page 59 LifePath -C Clinical Instructic s for Use 11.3 Bluetooth Disconnection The Bluetooth connection can be involuntarily terminated while monitoring in several ways:

1. Excessive distance between the Wearable Medical Monitor and Smartphone. 2. Wearable Medical Monitor battery completely depleted (0%) 3. smartphone battery completely depleted (0%) Disconnected @

The Wearable Medical Monitor has been disconnected from, this smartphone. Perform one or more of the following steps to reconnect.

| Check the battery status and insert a fully recharged battery if necessary 2. Return to within a few eet of the smartphone Disconnection popup displayed on Dashboard. The popup will dismiss automatically when connection has been re-established. Page 60 www.elasticcare.com o1 In cases 1 and 2, a popup indicating that the Wearable Medical Monitor has been disconnected will be displayed on the Dashboard. Instructions to come back within Bluetooth range and/or insert a fully charged battery into the Wearable Medical Monitor are given. While disconnected, the Smartphone will continue to search for the paired Wearable Medical Monitor. If found (by returning within range, or ifa charged battery is inserted into the Wearable Medical Monitor), the connection will be automatically re-established. In the case that the Wearable Medical Monitor is out of range, but still has battery power, it will continue to collect data. This data will be transmit-

ted to the Smartphone once the connection is re-established

* IF the Wearable Medical Monitor has battery power, but is oUt of range, the LED will stop blinking BLUE. 2023/07 Ee Basie LifePath -C Clinical Instructions 11.3. Bluetooth Disconnection If the Disconnection popup is dismissed, the Dashboard will reflect the current Searching monitoring state. The Smartphone will search indefinitely until the Wearable Medical Monitor is found, or a scheduled maintenance is started. When the Wearable Medical Monitor comes back into range and/or a charged battery is inserted into it, the Bluetooth connection will automatical-

ly be restored and monitoring will resume. Q ureratnc Luterath-c

(...] Searching Connecting a a=

@v Connected Wearable Medical Monitor Wearable Medical Monitor Connection between disconnected. Smartphone found, smartphone and Wearable searching, Medical Monitor re-established Monitoring resumes autornatically. Monitoring ol 2023/07 www.elasticcare.com Page 61 LifePath -C = Clinical Instruct 11.3. Bluetooth Disconnection In the case 3, wherein the Smartphone battery is completely depleted and the device powers OFF while in a monitoring state, the Wearable Medical Monitor will contine to collect data (provided it has battery power) Plug the Smartphone into the Smartphone Charger. Then plug the Smart-

phone Charger into a wall power outlet to begin recharging. Once powered ON, the Smartphone will boot automatically into the Elastic Care Mobile Application Dashboard and monitoring will automatically resume. Smartphone boots into Elastic Care Mobile Applica-

tion once sufficiently charged. Monitoring automatically Monitoring eegiopan resumed. Page 62 www.elasticcare.com 01 2023/01/17 LifePath -C Clinical Instructions for Use 11.4. Wi-Fi Disconnection If the Smartphone gets disconnected from the current Wi-Fi network, a popup will be displayed on the Dashboard indicating the loss of connectivity. Tap the Proceed button to be taken to the Smartphone's Wi-Fi settings and connect to a network. Note: an internet connection is required for the operation of the LifePath-C system. It is important to connect to a network as soon as possible after loss of connectivity. FP WiFiConnection @

The popup shown here will be displayed every few Sec cta minutes until the Smartphone is connected to a ee eney Wi-Fi network with internet access. If there is no Wi-Fi access, and LifePath-C has been set up with an LTE connection, the Smartphone will switch to mobile data (LTE). Carrier charges may apply. If no internet connection is available, the Smartphone will store up to 7 days of data received from the Wearable Medical Monitor. As long as a Bluetooth connection between the two devices exists, which facilitates transfer of collected data from the Wearable Medical Monitor to the Smartphone, monitoring can continue. However, this may require the stored data backlog to be transferred to Elastic Care's servers at the end of the monitoring campaign in order to generate a complete report. See the section titled Campaign End - Stored Data Transfer for more information o1 2023/01/17 www.elasticcare.com Page 63 LifePath -C Clinical Instructions for Use 11.5 No Internet Connectivity If the Smartphone is connected to a Wi-Fi network, but there is no internet access, a popup will be displayed on the Dashboard. Check the modem and/or router settings to troubleshoot. The popup will dismiss automatically when internet connectivity is restored. Tap the Retry Connecting button to be taken to the Smartphone's Wi-Fi settings to attempt to connect to another Wi-Fi imemer connection @ rictwoile Top Rory Conmecting! when you Toad chuck connection Check the modem and/or router settings in order to restore internet connec-

tivity. As mentioned in the previous sub-section, without an active internet connection, the Smartphone will store up to 7 days of collected data received from the Wearable Medical Monitor. See the section titled Campaign End - Stored Data Transfer for more information. Page 64 www.elasticcare.com Ol 2023/0/17 LifePath -C Clinical Instruction:

or Use 12 Wearable Medical Monitor Alerts 12.1 Vibration Alerts The Wearable Medical Monitor will vibrate in the following scenarios: When a vibration is felt, check the Elastic Care Mobile Application on the Smart:

phone to view any accompanying notifications. These notifications will contain additional information and, when applicable, instructions to trouble-

shoot any issues. Wearable Medical Monitor has been disconnected from the Smartphone 1 The Wearable Medical Monitor has moved out of range of the Smartphone, The Wearable Medical Monitor will vibrate ONCE. 2 Monitoring has been paused. The Wearable Medical Monitor will vibrate ONCE. Cable Harness unplugged from Wearable Medical Monitor The Cable Harness has been disconnected from the Wearable Medical Monitor's Cable Harness Port. The Wearable Medical Monitor will vibrate ONCE every minute. One or more ECG Leads off One or more ECG leads have come off contact with the patient's torso. The Wearable Medical Monitor will vibrate ONCE every minute. Wearable Medical Monitor Battery Low The Wearable Medical Monitor battery is low in power (5% and lower) The Wearable Medical Monitor will vibrate ONCE every minute. o1 2023/01/17 www.elasticcare.com Page 65 LifePath -C Clinical Instructic 12.2 LED Alerts The Wearable Medical Monitor has two LED's which will indicate hardware and connection statuses. Data transmission LED Light Info/Status Indicator LED Light Wearable Medical Monitor has been disconnected from the Smartphone Data transmission LED: Blue LED stops blinking Info/Status Indicator LED: Green LED blinks every second Cable Harness unplugged from Wearable Medical Monitor Data transmission LED: Blue LED continues blinking every second Info/Status Indicator LED: Amber LED blinks every second One or more ECG Leads off Data transmission LED: Blue LED continues blinking every second Info/Status Indicator LED: Amber LED blinks every second Wearable Medical Monitor Battery Low Data transmission LED: Blue LED continues blinking every second Info/Status Indicator LED: Amber LED blinks every second Page 66 www.elasticcare.com Ol 2023/0/17 Ee re LifePath -C Clinical Instruction or Use 13 Battery and Power ol 13.1 Wearable Medical Monitor Battery Power The Wearable Medical Monitor is powered by its rechargable, removable lithium ion battery and can operate continuously for up to 24 hours, at which point, the battery must be replaced with one that is fully charged in order to continue operation. Failure to replace a depleted battery with one that is fully charged can result in data loss. 13.2 Spare Wearable Medical Monitor Battery In order to facilitate uninterrupted, continuous monitoring without the need to wait for a battery to recharge, two (2) Wearable Medical Monitor Batteries are included in each LifePath-C package. Ensure one battery is always charging in the Battery Dock charger while the other is inserted in the Wearable Medical Monitor to allow for the fast swapping of a depleted battery with one that is fully charged when required. Swapping of batteries should be done during scheduled Maintenance 13.3 Battery Safety Keep Wearable Medical Monitor Batteries away from fire, excessive heat, and ignition sources A Do not get the Wearable Medical Monitor Battery wet. Do not atternpt to puncture, or tamper with the Wearable Medical Monitor Battery. Do not use a Wearable Medical Monitor Battery that is darnaged Do not insert a Wearable Medical Monitor Battery into a damaged Wearable Medical Monitor. Do not dispose of Wearable Medical Monitor Batteries in the trash 2023/0V17 www.elasticcare.com Page 67 13.4 Low Battery Warning LifePath -C Clinical Instruction:

When the Wearable Medical Monitor Battery is low (approximately 5% or less), a popup will be displayed on the Dashboard indicating the low battery status. The patient will be instructed to return to the healthcare facility in order to have the battery changed with one that is fully charged. In addition, the Wearable Medical Monitor will vibrate once per minute while the battery is under 5% and the LED Indicator Light will blink AMBER Page 68 Wearable Medical Monitor Battery Low Please contact your healthcare provider as soon as possible, Current battery The healthcare facility should ensure that one of the two Wearable Medical Monitor batteries included in the LifePath-C package is always fully charged. This reduces the risk of lost data due to The Wearable Medical Monitor having no battery power for an extended period of time. Ensure that a depleted battery is always placed immediately into the Battery Dock Charger and is charging. www.elasticcare.com ol 2023/01/17 LifePath -C Clinical Instructions for Us 13.5 Swapping Batteries 1] _ Prior to swapping batteries, tap the Pause Monitoring button on the Dashboard to pause the monitoring. While attached to the patient, remove current Wearable Medical Monitor battery and slide in a fully charged battery. Press the Start Monitoring button to resume monitoring. Insert depleted battery into the Battery Dock charger to charge. Depleted 2 Battery 3 id Charged Battery cP} @) e e 1 I Battery

! i I Ol 2023/0/17 www.elasticcare.com Page 69 Ee ore LifePath -C Clinical Instructions for Use 14 Data Storage 14.1 Wearable Medical Monitor Data Storage In the event that the Wearable Medical Monitor is disconnected from the Smartphone while monitoring, it will store the most recent 24 hours of data collected to its onboard storage. Upon re-connecting with the Smartphone, the stored data is sent before resuming real-time data transfer. Depending on the amount of stored data, this may create a buffer or backlog of data, which will need to be flushed to the Smartphone at the end of the monitoring campaign. See the section titled Campaign End - Stored Data Transfer 14.2 Smartphone Data Storage In the event that the Smartphone is disconnected from the internet during the monitoring campaign, it will store the most recent 7 days of data to its, onboard storage. Upon re-connecting to the internet, the stored data is sent to Elastic Care's servers before resuming real-time data transfer. Depending on the amount of stored data, this may create a buffer or backlog of data, which will need to be flushed from the Smartphone to Elastic Care's Servers at the end of the monitoring campaign. See the section titled Campaign End - Stored Data Transfer Page 70 www.elasticcare.com ol 2023/01/17 LifePath-C Clin Instructions for Use 15 Cleaning the LifePath-C System 15.1 Warnings and Cautions for Cleaning the LifePath-C System The following warnings apply to the cleaning of the LifePath-C system hardware. Where applicable, refer to relevant steps during the Maintenance Procedure for more information AX _ Use only materials supplied and recommended for cleaning the LifePath-C system hardware. Do not pour water on any LifePath-C hardware. Do not submerge LifePath-C hardware in a bleach solution. To avoid cross contamination, properly clean all reusable components of the LifePath-C system and use disinfecting wipes on all hardware surfaces. Do not pour any liquid on the Wearable Medical Monitor, Wearable Medical Monitor Battery, Battery Dock Charger, or Charging Adapter, Do not clean Wearable Medical Monitor Battery or Battery Dock Charger while battery is charging. Do not use abrasive cleaning agents, Do not autoclave LifePath-C hardware.

>PP PP PDP PPD Ensure the ECG cable Is dry before connecting it to the Wearable Medical Monitor. ol 2023/0/17 www.elasticcare.com Page 71 LifePath -C Clinic Instructic 15.2 Cleaning Procedure 1. Use one of the provided Adhesive Remover Wipes to remove any remaining adhesive from the back surface of the Wearable Medical Monitor. 2. With the provided 70% Isopropyl Alcohol Swabs, wipe away any dirt, oil, or debris from all surfaces of LifePath-C hardware; Wearable Medical Monitor, Wearable Medical Monitor Battery, Harness, ECG Snaps, and Wearable Medical Monitor Battery Dock Charger. 2. Use multiple swabs if necessary. Do not use any other cleaning materials or chemicals 15.3 Additional Cleaning Measures 1. Use a disinfecting wipe to wipe down all LifePath-C hardware surfaces. 2. Use a clean, dry soft cloth or paper towel to thoroughly dry LifePath-C hardware surfaces. 15.4 Disposing of Used Consumables Adhesive Patches, ECG Electrodes, Alcohol Swabs, or Adhesive Remover Wipes. These components may contain bio-hazard materials. Handle and dispose of these materials according to your facility's policies. A Do not re-use single use disposable components such as Page 72 www.elasticcare.com Ol 2023/01/17 Ee fasnie LifePath - Clinical s for Use nstructic 16 Maintenance During the monitoring campaign, scheduled maintenance of the LifePath-C system will need to be performed by the nurse or nurse equivalent approxi-

mately every 24 hours. A reminder message popup will be displayed on the mobile application Dashboard, instructing the patient to contact the healthcare facility for the scheduled maintenance as soon as possible

*Ensure the patient is present, along with the listed items, prior to tapping the Proceed to Maintenance button. When the maintenance procedure begins, monitoring will be paused automatically. Scheduled Scheduled Maintenance Due Maintenance Youare abou tostart tho Due fice mnstn Mtoe eet the Ps contac you heen Eien rosie biti iborpatear i + Hote pode orto Neohel Seat Maintenance Due reminder List of required persons and popup. Tapping Start items for scheduled mainte:

Maintenance Procedure button nance. will bring up list of required persons and items for scheduled maintenance. Tapping Proceed to Mainte-

nance" button will start Maintenance Procedure. ol 2023/01/17 www.elasticcare.com Page 73 16 Maintenance LifePath -C Clinical Instructions If the Maintenance Due reminder popup is dismissed, the Dashboard will appear as it does below until the Scheduled Maintenance is performed. In order to start the maintenance procedure, tap the Start Maintenance Procedure button on the Dashboard. Dashboard Sons 7 Scheduled Maintenance Due tafepath-c aso abt os he sts proces Tis Scheduled rare tet youn Maintenance arate Due + lie er Monitoring apn @ oe List of required persons and items for scheduled Maintenance Due reminder on Dashboard. Tapping Start Maintenance Procedure button maintenance. will bring up list of required persons and items for scheduled maintenance. Maintenance screens will be displayed on the Elastic Care Mobile Application. Tap the Next button after each step is completed to advance to the next step. Page 74 www.elasticcare.com Ol 2023/0/17 16 ol LifePath - C Maintenance Clinical Instructions for Use List of required items for Scheduled Maintenance:

@ =~ Wearable Medical Monitor Battery (Charged) Wearable Medical Monitor Battery Dock Charger Adhesive Patch New ECG Electrodes Alcohol Swabs, Adhesive Remover Wipes Smartphone charger Tap the Proceed to Maintenance button. Read and acknowledge all warnings and cautions, Tap the | Acknowledge button to begin when prompted Warning /A\

The following warnings apply to the cleaning the LifePath-C system hard-

ware. Refer to the relevant steps during this maintenance procedure for more information 2023/07 Use only materials supplied and recommended for cleaning LifePath-C hardware. Do not pour water on any LifePath-C hardware. Do not submerge the LifePath-C system in bleach solutions To avoid cross contamination, properly clean all reusable compo-

nents of the LifePath-C system. Do not pour any liquid on the Wearable Medical Monitor, Wearable Medical Monitor Battery, Battery Dock Charger, or Charging Adapter. Do not clean Wearable Medical Monitor Battery or Battery Dock Charger while battery Is charging, www.elasticcare.com Do not use abrasive cleaning agents. Clean all LifePath-C hardware after every use. Do not autoclave LifePath-C hardware. Ensure the ECG cable is dry before connecting it to the Wearable Medical Monitor. Disposable components such as ECG electrodes, alcohol swabs, and adhesive remover wipes may contain bio-hazard materials. Handle and dispose of these materials according to your facility's policies, Do not re-use disposable components. Page 75 Step 1 Remove from Patient Carefully remove the Wearable Medical Monitor with the attached harness + Adhesive Patch, and all electrodes from the patient's torso. i LifePath -C Clinical Instructions for Us Step 2 Detaching Detach the Cable Harness from the Wearable Medical Monitor. Ay Donot wiggle the harness connector as it may damage the Wearable Medical Monitor and/or Cable Harness. Page 76 www.elasticcare.com Ol 2023/01/17 Step 3 Detaching Detach all ECG electrodes and discard. Peel off Adhesive patch from Wearable Medical Monitor LifePath -C Clinical Instructions for Us Step 4 Remove used battery Slide out the used battery from the Wearable Medical Monitor. used battery and discard. 1 X10 (or x 4) pe ZX Doenot re-use single use products. ol 2023/0/17 www.elasticcare.com Page 77 Step 5 Clean Device Use one of the included Adhesive Remover Wipes to remove any remaining adhesive from the back surface of the Wearable Medical Monitor.

*Note- do not re-use Adhesive Remover Wipes. Discard after each use. ZX _ Doenot re-use single use products. Page 78 LifePath -C Clinic structions for Use Step 6 Clean Device Use a disinfecting wipe (not included) to thoroughly wipe down the LifePath-C system hardware. ZX Doenot use excessive amounts of liquid when cleaning LifePath-C hardware. www.elasticcare.com Ol 2023/01/17 Step 7 Dry Surfaces Use a clean dry cloth to remove excess alcohol or liquid from all surfaces. Ensure the device is completely dry. AX Do not re-use single use products. ol 2023/0/17 LifePath -C Clinic www.elasticcare.com Instructions for Use Step 8 Clean Patient Use an alcohol swab (included) and clean patient's torso.

*Note- do not re-use alcohol swabs. Discard after each use ZX Donct re-use single use products. Page 79 Step 9 Insert a fully charged battery Fully charged battery Page 80 LifePath -C Clinical Instructions for Us Step 10 Peel, align, and attach a new adhesive patch. www.elasticcare.com Ol 2023/01/17 Step Tl Select harness, snap electrodes, and insert harness. PO >

x10 (or x 4) ol 2023/0/17 www.elasticcare.com LifePath -C Clinical Instructions for Us Step 12 Attaching Flip, peel backing, and attach to patient's sternum,

*Note- do not re-use adhesive patch. Discard after each use Page 81 Step 13 (12-Lead) Attaching One at a time, peel electrodes and attach to the patient's torso as shown. LifePath -C | Clinical Instructions for Us Step 13 (6-Lead) Attaching One at a time, peel electrodes and attach to the patient's torso as shown. A rr vi M3 V4 Ve RL LL

*Note- do not re-use electrodes. Discard after each use. Page 82 www.elasticcare.com A iw RL LL Ol 2023/01/17 LifePath -C Clinical Ins Step 14 Recharge Maintenance Charge the discharged Wearable Com pl ete Medical Monitor Battery as well as the Smartphone. Used battery Red

- charging

=) This step must be Green performed during the Maintenance Procedure in the Elastic Care App.

- Fully charged Tapping the Finish button on the final maintenance screen will bring you back to the Dashboard. Finish Tap the Start Monitoring button on the Dashboard to resume monitoring. After doing so, you can

() discharge the patient. Not Monitoring Press to start monitoring Ay Use only provided Smartphone charger. Use of other cables and/or adapters can cause damage to the Smartphone. ol 2023/0//17 www.elasticcare.com Page 83 LifePath -C Clinical Instructions for Use 17 Campaign End When the selected length of time for the monitoring campaign has elapsed, the campaign will end automatically. Monitoring will stop and the Wearable Medical Monitor will halt data collection. The monitoring state will revert to Not Monitoring Monitoring Not Monitor Press to start monitoring, Press to pause monitoring, Monitoring will automatically stop when the campaign duration has elapsed. Note: it is NOT possible to re-initiate monitoring after a campaign has ended IF you would like to continue monitoring, you will be required to set up a new monitoring campaign. Ending a Monitoring Campaign Early If required, you can end a monitoring campaign early by tapping the Logout button inside the Settings menu. Note: this should be carried out by autho-

rized personnel only (physician, nurse, or healthcare provider responsible for the patient). Ending a campaign early cannot be undone. Remove LifePath-c System Once the campaign has ended, you may remove the LifePath-C system from the patient. For more information, see the section titled Removing and Returning. Important Steps After End of Monitoring While the monitoring campaign has ended, there may still be data on board the Wearable Medical Monitor and/or Smartphone. This data needs to be sent to Elastic Care's servers in order to generate a complete report. At the end of the monitoring campaign, you will be given the option to transfer this data. See the section titled Campaign End - Stored Data Transfer for more information, Page 84 www.elasticcare.com ol 2023/01/17 Ee Ease LifePath = Clinical Instructions for Use 17.1 Campaign End - Stored Data Transfer If there is data stored either on the Wearable Medical Monitor or the Smart-

phone at the end of a monitoring campaign, you will be notified and a given the option to transfer the stored data to Elastic Care's servers. It is highly recommended that this be done in order to generate a complete report. Follow the prompts given on the screen to transfer the stored data. Ensure that the Wearable Medical Monitor has a full battery, and the Smartphone is connected to a power source, as well as a Wi-Fi network, prior to beginning the data transfer.

*Do NOT remove the Wearable Medical Monitor battery or turn the Smartphone OFF during data transfer. If the Wearable Medical Monitor's battery runs low during the transfer, you'll be prompted to charge it. Follow instructions for charging, insert a fully charged battery into the Wearable Medical Monitor, and resume the data transfer. Important! Transferring Transfer Data Complete!

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Once the transfer has been completed, you can turn the Smartphone OFF, remove the LifePath-C system from the patient and follow the cleaning procedure as outlined in this user manual If the Wearable Medical Monitor Battery becomes low, the transfer will automatically pause, and you will be instructed to insert a fully charged battery before continuing the transfer. o1 2023/01/17 www.elasticcare.com Page 85 LifePath-C Clinica 18 Removing and Returning 18.1 Removing LifePath-c After the monitoring campaign has ended, you may detach LifePath-C from the patient. Follow Steps 1 through 8 of Maintenance Procedure in order to 1. Remove the Wearable Medical Monitor from the patient 2. Unplug the Cable Harness from the Wearable Medical Monitor 3. Peel off the Adhesive Patch from the Wearable Medical Monitor and discard the used Adhesive Patch:

4. Unsap the ECG Leads from the ECG Electrodes and discard the used ECG Electrodes. 5, Use one of the included Adhesive Remover Wipes to remove any residual adhesive on the back surface of the Wearable Medical Monitor. Once completed, follow the following steps (Also outlined in the Return Instructions Card) to return the LifePath-C to Elastic Care. Page 86 www.elasticcare.com Ol 2023/01/17 LifePath -C Clinical Instructic 18.2 Returning LifePath-c Ensure that the Wearable Medical Monitor, batteries, and all other compo-

nents are accounted for prior to returning. Do not mix components from different LifePath-c packages. 1 _ Discard the sleeve il , Component checklist Smartphone Wearable Medical Monitor Wearable Medical Monitor 2 collect all components Battery x2 and complete checklist as you carefully repack them into their slots in the LifePath-C box. Wearable Medical Monitor Battery Dock Battery Dock Charging Adapter Smartphone Charger ECG Harness

(12 Lead & 6 Lead) Wearable Medical Monitor Adhesive Patches Alcohol Swabs Adhesive Remover Wipes 000. 0: ..0: 0 0 00:0 ECG Electrodes ol 2023/0/17 www.elasticcare.com Page 87 LifePath -C Clinical Instructions for Us 18.2 Returning LifePath-c Attach included seals 6 Call FedEx at 1.800.463.3339 on the spaces indicated (1.800.GoFedEx) to arrange on the box for a pickup. RS O O 4 Fill the Shipping Air Waybill provided If you have questions, or if the;

device is damaged, contact ug immediately at:

1.800.GoMyECG (1.800.466.9324) 5 Place waybill into shipping pouch and attach pouch where indicated on the box Page 88 www.elasticcare.com Ol 2023/01/17 Ee magne LifePath -C Clinical Instructions for Us 19 Third Party Devices LifePath-C can be used with Elastic Care-approved, Bluetooth enabled third-party devices in order to collect additional signals/data during the monitoring campaign. Blood pressure monitors, pulse oximeters, and glucometers can be added to the LifePath-C monitoring campaign by tapping the Devices tab, then the +Add Devices button With a device added, you can control it, as well as see the readings it has obtained within the Dashboard for the selected device. Data obtained from third party devices are sent to Elastic Care's servers, and are added to the campaign reports. Note: All readings displayed on the LifePath-C Dashboard for the device are as they appear on the device, with no processing, analysis, or approximation. 19.1 Adding A Third-Party Device During a monitoring campaign. Tap the Devices Devices tab in the botton navigation menu You will see a Device Card for the current ee device, LifePath-C, along with information pertaining to the connection and monitoring status of the Wearable Medical Monitor.

@ we feet Tap the +Add Devices button at the top of the

[ status J screen to begin the Add Devices procedure. Devices

SSS ol 2023/01/17 www.elasticcare.com Page 89 LifePath -C Clinical Instructions for Use 19.1 Adding A Third-Party Device The Add Devices procedure consists of the

< Devices following three steps Add Devices See 1. Bring the third-party device close to the Smartphone Sse having! 2. Tum the device ON 2 tumton 3. Pressand hold the Bluetooth button on the device until

* Garnet ashes the device's Bluetooth LED begins to flash. This will enter it into Bluetooth pairing mode. U td With the device in Bluetooth pairing mode, the Smartphone will automatically detect its presence and add it to LifePath-C campaign Note: Devices must be added one atime. wo Successfully added devices will be listed, along aac with the type of device (Ex Blood Pressure cama care Monitor), and model number. eee Sng thetotowings ad You can remove an added device by tapping

(RE I the remove button Note: If the device does not have a Bluetooth Blood Pressure i Monttor pairing button, consult the manufacturer's Tao 1-1 instructions regarding entering the device into Dena oeineeer Bluetooth pairing mode. With the devices added, you can tap the back

< button at the top of the screen to return to the Devices screen.

< Devices Successfully added devices will automatically be shown. Page 90 www.elasticcare.com 01 2023/0V/17 ES eae LifePath -C Clinical Instructions for Use 19.1 Adding A Third-Party Device When a third-party device has been successfully EXSUEES added to the LifePath-C campaign, it will appear in Siceoe Ion the list of devices in the Devices section of the Scroll down to view its Device Card, which will contain information about the device. vasa 19.2 Switching To A Third-Party Device Tap the device's Device Card to switch to the Mca See selected device. Change Current Device?

Seitching to thd pry A popup prompting you to confirm switching to By tapping Proceed, you the third party device Secteur ae will be displayed. Seeand peed al warnings Read the manufacturer's instructions for use, and Qo ensure to heed all warnings and cautions prior to. tapping the Proceed button ol 2023/0/17 www.elasticcare.com Page 91 LifePath -C Clinical Instruction or Use 19.2 Switching To A Third-Party Device 2 Upon confirming the switch to a third-party mevices: device, it will be labeled as the Current Device. o Taidoc TD-3140 Winn to To switch back to LifePath-C, tap its device card The Dashboard will revert back to displaying its Device Control Card. Note: If the last known state of the Wearable Medical Monitor was Monitoring and the Wearable Medical Monitor has battery power, it will continue to collect data while third-party devices are in use. 19.3 Using A Third-Party Device When switched over to a third-party device, the Dashboard maui Dashboard will display its Device Control Card, cae? as it is the current device. Blood Pressure Cut

[ The Dashboard will display all readings obtained with the device Readings are not modified, adjusted, processed, or altered in any way. Tapping the Start button will instruct the device to begin taking a measurement. Results are displayed in real time. Note: Prior to tapping start, ensure the device is powered ON and near the Smartphone. Page 92 www.elasticcare.com ol 2023/01/17 LifePath -C Clinical Instrt r Use Dashboard Dashboard Dashboard Measuring fom z@) come fs @ 2 Example: A blood pressure measurement being taken with a paired blood pressure cuff, Time of most recent reading will be displayed under each measurement. Multiple Measurements There is no limit to the number of measurements you can take with third-party devices Tapping the Start button after a measurement has completed will take a new one. Only results of the most recent measurement will be displayed All measurements obtained by third-party devices will be added, along with their time stamps, to LifePath-C campaign report Switching Back to LifePath-C Tapping the LifePath-C Device Card from the Devices screen will make the Wearable Medical Monitor the current device once again. The monitoring state will revert to last known state prior to switching to a third-party device. o1 2023/01/17 www.elasticcare.com Page 93 Ee nea LifePath - C 20 Thresholds For Vitals During the setup process, you will be prompted to enter upper and lower thresholds for various biometric parameters collected during the monitoring campaign. Reports will show when these have been breached. It is import-

ant to check with the assigning physician for these values prior to setting up a monitoring campaign Heart Rate

>> Resp.Rate skin Temp. GB Respiration Rate Skin Temperature Gse) GS) ower upper lower upper Gretna threshota recnoa threshold ovo wear te QE cen rene Page 94 www.elasticcare.com O1 2023/01/17 LifePath -C Clinical Instructions for Use 21 Reports Clinical reports as shown below will be sent in a periodic manner based on the delivery frequency selected during the campaign configuration. The report period starts when the patient monitoring has commenced. ER towrorcomee ron ol 2023/07 www.elasticcare.com Page 95 Ee ELAstic LifePath -C Clinical Instruc r Use 22 Pre-Launch Check Errors The following will detail the error cases you may encounter during the Pre-Launch Check. If an error is found during one of the stages, it will be indicated with a red 'x @ symbol and you will be required to correct the error before advancing to the next stage of the Pre-Launch Check In each error case, you will be provided with a description of the error, as well as steps to troubleshoot it. Once corrected, a large green checkmark symbol will be displayed, and the 'Proceed button will become active. Tapping this button will re-initiate the Pre-Launch check. Lifepath-c Pre-launch PF Ecc cable and Leads @

Check Cable Harness ts not connected, Insert harness as shown, Tap Proceed when finished. Hardware check Connectivity check Calibration and signal check Pre-Launch Error Example Description of Error Example Ated x indicating an error relating to Description of error given with trouble-

Hardware. shooting steps. Proceed button will activate once corrected, Page 96 www.elasticcare.com ol 2023/01/17 or Hardware Errors Hardware error @

A hardware error was detected, The device may not be functioning properly. f For Immediate assistance, Elastic or Ifavallable, try a new LifePath-c package, Note: prior to opening a new package, repack all contents and follow Return instructions, Hardware Error A hardware error was detected. The device ray be malfunctioning Solution:

Call Elastic Care for immediate assistance, or try a new LifePath-C package if available. 2023/01/17 LifePath-C Clini structions Pre-Launch Check Errors P ECG Cable and Leads @

able Harness Is not connected Insert hamess as shown, Tap Proceed when finished. ECG Cable Harness Disconnected The ECG Cable harness is not connect ed to the Wearable Medical Monitor. Solution:

Insert the Cable Harness connector nto the port as shown. www.elasticcare.com Page 97 LifePath-C Clin Instructions 22 Pre-Launch Check Errors Hardware Errors P ECG Cable and Leads @

one or more of the ECG leads are not connected. tach as shown below, Tap Proceed when finished ECG Leads Disconnected

(One or more of the ECG leads are disconnected or improperly attached. Solution:

Ensure all leads are attached as described in the diagram above. Ensure each electrode Is in contact with the patient's skin. 2 Connectivity Errors

> wi-Ficonnection @

The Smartphone fs not connected toa WEFI network An internet connectionis requited Tap Proceed to connect to a network, No Wi-Fi Connection The Smartphone is not connected to a Wi-Fi network Solution:

Tap Proceed to access the Smartphone's Wi-Fi settings and connect to an available wireless network, Page 98 www.elasticcare.com o1 2023/01/17 or Lee LifePath - C structions 22 Pre-Launch Check Errors 2 Connectivity Errors internet connection @

There doesn't seem to be an Internet connecton. Please check your modem and/or router settings. Tap Retry Connecting when you're ready to check the connection, No Internet Connection

% Bluetooth signal @

There Is a weak signal between the Wearable Medical Monitor and this smartphone. Please move the two closer together to improve the signal strength There is no internet connection. Weak Bluetooth signal between the Wearable Medical Monitor and Smartphone. Solution: Solution:

Check your modem and/or router Move the two devices closer together settings and retry connecting. Or, until the signal strength improves. try connecting to another Wi-Fi network 2023/0V17 www.elasticcare.com Page 99 ELASTIC LifePath-C = Clin structions 22 Pre-Launch Check Errors

-} Calibration & Signal Errors

> calibration error @ roo signals e Calibration had to stop because We noticed some problems there was loo much movement. while checking the signals, Please remain still and in a seated position and refrain from any large movements. ety calibration The patient was sul Calibration Error Signals Error There was too much movement There were problems with the signals detected during calibration which collected during the calibration. caused it to stop. Solution: Solution:

Ensure the patient is still, and in a seated Retry calibration. Ensure the contact position. Refrain from any large areas of electrodes and skin are clean, movements until calibration has , contact Elastic Care for assistance. completed. Page 100 www.elasticcare.com O1 2023/01/17 LifePath -C Clinical Instruction or Use 23 FAQ's ol Q fe) Where do | find the login information for the Elastic Care Mobile Application?

The physician and/or nurse email addresses your facility provided on the Elastic Care Client Sign Up Form will receive a welcome email with login details to be used on the Elastic Care Mobile Application How do | know that the Wearable Medical Monitor is functioning normally?

The LED on the Wearable Medical Monitor will blink a green light every second. How long can the Wearable Medical Monitor be continuously worn at one time?

The Wearable Medical Monitor can be worn no longer than 24 hours. Ascheduled maintenance must be performed every 24 hours. How can | access the patients physiological data?

Patient reports will be sent to the Physician's email in a PDF format at a frequency of their choosing (hourly, daily, weekly). This frequency is selected during the Campaign Configuration performed on the Smartphone when setting up a new monitoring campaign. You can also set additional recipients of these reports during this time (limited to physicians and nurses in the healthcare facility) Can the Wearable Medical Monitor be used without the included Smartphone?

No. The Wearable Medical Monitor only works in conjunction with the Smartphone provided in the LifePath-C package. It cannot function as a standalone device. 2023/07 www.elasticcare.com Page 101 LifePath -C Clinical Instruction 23 FAQ's Q A Page 102 Is there an emergency button on the device that the patient can use to alert someone?

No. There is no emergency button on the Wearable Medical Monitor. Can the patient wear the Wearable Medical Monitor while taking a shower or doing other water-based activities?

No. The Wearable Medical Monitor and other components are not intended for use while showering or other water-based activities. Will an alert be sent if the patient's vitals are above or below set thresholds?

No alerts will be sent if thresholds are breached. However, the physician will be informed of any out of bound parameters in the Patient Report sent to them What should | do if the Werable Medical Monitor or Smartphone are broken?

If the Wearable Medical Monitor or Smartphone are physically dam-

aged or broken, contact Elastic Care immediately. Where can | see notifications for the Wearable Medical Monitor?

In the Elastic Care Mobile Application, the Notifications button in the Navigation Menu will contain a red badge, along with the number of pending notifications. Tapping this will take you to the Notifications section, where you will be able to view all logs and alarms. www.elasticcare.com ol 2023/01/17 or 23 fe) LifePath -C Clinica FAQ's There is a Device Reset and Recovered Notification. What does this mean?

The Wearable Medical Monitor was reset and recovered to a normal, working condition Why is the Wearable Medical Monitor vibrating?

The Wearable Medical Monitor vibrates if any of the ECG leads are off, the ECG Cable Harness is disconnected from the Wearable Medical Monitor, the Wearable Medical Monitor Battery is low, or if the Bluetooth connection between the Smartphon and Wearable Medical Monitor has been lost. 2023/01/17 www.elasticcare.com Page 103 Ee Ease LifePath -C Clinical Instructions for Us 24 Troubleshooting The Wearable Medical Monitor is not turning ON Cause Wearable Medical Monitor Battery is not inserted properly. Wearable Medical Monitor Battery might be completely depleted. Solution Insert a spare, fully charged battery into the Wearable Medical Monitor. The Smartphone is not turning ON cause * Smartphone battery might be completely depleted Solution Charge the Smartphone by plugging it into a wall power outlet using the provided cable and power adapter. The Wearable Medical Monitor is vibrating, the LED is blinking an amber light and there is an ECG Lead Disconnected notification. Cause * One or more of the ECG leads are disconnected. Solution Connect the snaps to the respective electrodes and ensure all ECG electrodes are firmly attached to the patient's torso. Page 104 www.elasticcare.com Ol 2023/01/17 Ee mnie LifePath -C Clinical Instructions for Us 24 Troubleshooting The Wearable Medical Monitor is vibrating, the LED is blinking an amber light and there is an ECG Cable Disconnected notification. Cause The Cable Harness is disconnected from the Wearable Medical Monitor. Solution = @ Insert the Cable Harness connector into the Wearable Medical Monitor port marked in blue. The LED on the Wearable Medical Monitor is not blinking a blue light and there is a Disconnected notification. Cause There is no Bluetooth connectivity between the Wearable Medical Monitor and the Smartphone. Solution Bring the Smartphone closer to the Wearable Medical Monitor in order to improve Bluetooth signal strength The Wearable Medical Monitor is vibrating, the LED is blinking an amber light, and there is a Low Battery 10% notification. cause * Wearable Medical Monitor Battery is low. Solution Tap the Pause Monitoring button on the Dashboard. Insert a fully charged spare battery into the Wearable Medical Monitor.

* Place the discharged battery into the charging dock to charge. Tap the Start Monitoring button on the Dashboard to resume monitoring, o1 2023/01/17 www.elasticcare.com Page 105 Ee easne LifePath -C Clinical structions for Use 24 Troubleshooting There is a Device Error Detected notification Cause = There is a problem with the Wearable Medical Monitor. Solution Tap the Pause Monitoring button on the Dashboard. Remove and re-insert the battery into the Wearable Medical Monitor. Wait for the device to start. If the notification persists, contact Elastic Care There is a notification log in the Elastic Care Mobile Application indicating lost Wi-Fi or Data connection Cause * Your patient may have walked way from the Wi-Fi zone/net-

work you are connected to. There is no internet connectivity on your Wi-Fi or Data network. Solution =e instruct the patient to walk back to the area or zone with Wi-Fi or data connectivity or connect to a new Wi-Fi network

* Troubleshoot your router and/or modem to re-establish internet and Wi-Fi/Data connectivity. Still having trouble?

Ifa problem you're encountering is not mentioned above, or the provided solutions are not resolving the issue, please contact Elastic Care for support. Page 106 www.elasticcare.com Ol 2023/01/17 25 LifePath-c inical Technical Specifications 25.1 Wearable Medical Monitor Temperature Environmental conditions for use Operation: $C to 45C Charging: C to 40C Relative humidity

(Operation: 10% to 95% without condensation Charging: 10% to 90% without condensation Atmospheric pressure 70 kPa to 106 kPa Environmental conditions for storage (Maximum 6 months) Temperature ISC- 25C Relative humidity 20% to 60%

Atmospheric pressure 70 kPa to 106 kPa External dimensions and weight Length 427mm. Width alamm Height ig.8mm Weight 35g (excluding cable harness) Case material Polycarbonate and Thermoplastic Polyurethane Battery Specification Capacity 350mAh (Nominal) 235mAh (Minimum) Battery type Tithium lon Battory voltage: IN Nominal) Full charge operating time 2a hours Ecc Sampling rate 2502 Digital resolution 20biIS Heart Rate (Range) 30 bpm to 240 bpm for normal sinus amplitudes of 0.05mv to SOomV Heart Rate Accuracy 96%

Respiration Modulation Excitation Signal SUR BORE epken Sampling 5 Hz Repiration Range 1S rpm to 40 bpm Respiration Accuracy 999%

Accoleromotor Activity Sampling 8333 Hz Recolerometer axis, 12 bit, 449 Activity/Posture Ranges No activity - Running/ Sitting up Lying down ol 2023/0/17 www.elasticcare.com Instructions for Use Page 107 LifePath -C Clinical Instructions for Use 25.1 Wearable Medical Monitor Skin Temperature Sampling Rato 1He Resolution orc Skin Temperature Sense Range 28C 10 45C. Accuracy of Reported Skin Temperature $F02C Sotting Time 10 minutes 25.2 AC/DC Medical Power Supply Manufacturer Phihong Model PSACOSR-OSOLEM Input 100.240VAC at 50-6OHz

(worldwide support) Output VDC at iA maximum Safety Standards cUL/UL Tu NOM ce cB FCC Class B ENS5022 Class B AS/NZS 3546 ENS0082-1 EN 61000-4-2, Lovel 4 EN 61000-4-5 Level Electrical protection level Double Insulated Primary to Secondary Hipot Result: 3KV AC 10mA, 60 seconds Case Tamm x 45mm x somm Page 108 www.elasticcare.com Ol 2023/01/17 LifePath -C Clinical Instructions for Use 25.3. Wearable Medical Monitor Battery Charger Input SVDC at 200mA maximum, Output Constant Current / Constant Voltage as required by the WMM Lithium lon battery pack: I175mA/ 4.2 Case Material Polycarbonate External Dimensions Length 36mm width 455mm Height 0mm 25.4 Vital Sign Measurement ECG Sensing The ECG system measures the electrical activity of the heart. The fidelity of the ECG waveforms and heart rate metric are influenced by ambulation, patient chest preparation

(good contact with electrodes) and environmental EMI. Respiration Sensing Respiration rate is determined through the variation in the patient's thoracic cavity imped-

ance. Thoracic cavity impedance changes through expansion and contraction of the chest during respiration. Patient breathing depth, ambulation and breathing style affect the respiration sensing system. skin Temperature Sensing Measures local skin temperature taken through skin contact on the thoracic region. Does not reflect patient core temperature or imply the temperature of a traditional human body reference site. Activity and Posture Sensing A3-axis accelerometer is Used to collect a patient's activity and posture. Activity and posture measurements obtained from this device should not be used for clinical diagnosis. This data should be used for reference only. Fall indications are not provided in real-time and should be used for reference only. o1 2023/01/17 www.elasticcare.com Page 109

Gain: 10 mnymv | Sweep: 25 mms HR: 90 0G_v3 Start 7023.08-18 1111-38 LP 100 He | HP 0.05 He PLE 60 He End: 2023-08-18 112145 Gain: 10 mnymy | Sweep. 25 mms HR: 90 Ea) Start2023.08-18 1111-45 UP 100 Hz | HP 0.05 He] PLE 60 He End: 2023-08-18 111.52 Gain. 10 mnvmy | Sweep: 25 mms HR: 90 cc.v2 Start 2023-08-18 114152 {P10 He | HP 0.05 He] PLE: 60 He End: 2025-08-28 1121'59 Gain: 10 mmm | Sweep: 25 mays R90 Eo Start7023.08:48 111159 LP 100 Hz | HP 0.05 He PLF 60 He End: 2023-08-16 21.12.06 Gain. 10 mmymy | Sweep: 25 mms HR: 90 ECGS i i ign i ie i Start-2023-06-18 111206 LP 100 Hz | HP: 0.05 He | PLE. 60 Hz: End: 2023-00-18 111213

Report No.:

ML300116-RF00 Issue Date: June 5, 2023 Elastic Care Client:

Product Name/Model: Mobile ECG and multi-sensor medical monitor / Lifepath-C FCC ID:

IC:

2BA2T-LPC1 30674-LPC1 FCC Label Location FCC label of device will be installed under the removable battery as shown in the following diagram. DEVICE TOP Battery Compartment FCC label Device: Lifepath-C DEVICE BOTTOM Megalab Group Inc. 150 Addison Hall Circle, Aurora, Ontario, L4G 3X8, Canada www.megalabinc.com (905) 752-1925 This report may not be reproduced, except in full, without prior written approval of Megalab Group Inc. Page 1 of 1

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Date 2023-05-26 Timco Engineering, Inc. 849 NW State Road 45, Newberry, Florida 32669, USA Dear Sir or Madam, We, Elastic Care Incorporated, hereby authorize Raymond Au of Megalab Group Inc., 150 Addison Hall Circle, Aurora, Ontario, L4G 3X8, Canada; 905-752-1925 to act as our agent in all matters relating to applications for equipment authorization, including the signing of all documents relating to these matters. The authorization expires on May 26, 2024. Yours sincerely, Name: Todd Meaney Title: Engineer

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2023-05-26 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: (2BA2T-LPC1) Elastic Care Incorporated (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. Sincerely, Todd Meaney

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 09-12-2023 Ref: Attestation Statements Part 2.911(d)(7) Filing FCC ID: (2BA2T-LPC1) Elastic Care Incorporated (the applicant) certifies that, as of the date of the filing of the application, Techlink International LLC is our designated U.S. agent for service of process for the above referenced FCC ID. Elastic Care Incorporated accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. Techlink International LLC accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service of process for the above referenced FCC ID. Designated U.S. Agent Information:

Name: Techlink International LLC Address: East Coast Office, 2875 NE 191st Street Suite #539, Aventura, FL 33180, USA. Contact Person: Lilian Llull Tel.: 305-206-6777 Email: lilian@techlinkusa.net Sincerely, Elastic Care Incorporated FRN 0033722059 Todd Meaney Techlink International LLC FRN 0034233189 Lilian Llull 95 Apple Creek Blvd., Markham, Ontario L3R 1C7 1-(416)-214-6363 info@elasticcare.com www.elasticcare.com

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 2023-05-26 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: (2BA2T-LPC1) Elastic Care Incorporated (the applicant) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List (as a specifically named entity or any of its subsidiaries or affiliates) as an entity producing covered equipment. Sincerely, Todd Meaney

Date: 2023-05-26 Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Confidentiality Request regarding application for certification of FCC ID: 2BA2T-LPC1 Pursuant to Sections 0.457(d)(1)(ii) and 0.459 of the Commissions Rules, Elastic Care Incorporated hereby requests permanent confidential treatment of information accompanying this application as outlined below:

Schematics Bill of Materials/Parts List Block Diagrams Theory of Operation Elastic Care Incorporated also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of period of 120 days:

Internal Photos External Photos User Manual Test Set-up Photographs The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457(d)(1)(ii) of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Name: Todd Meaney Title: Engineer