2A8VFAAMonitoring System using Bluetooth Low Energy

Instructions For Use (IFU) Continuous Glucose Monitoring System 2 Contents Starting out with sugarBEAT ® � � � � � � � � � � � � � � � � � � � � 5 Your sugarBEAT ® system � � � � � � � � � � � � � � � � � � � � � � � 6 Glossary of Terms � � � � � � � � � � � � � � � � � � � � � � � � � � � 8 Intended Use � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 12 What do you need to know before using sugarBEAT ® ? � � � � � � � 12 Contraindications � � � � � � � � � � � � � � � � � � � � � � � 13 Warnings � � � � � � � � � � � � � � � � � � � � � � � � � � � 14 What to know before you apply your sugarBEAT ® device � � � � 16 Your blood glucose level compared with sugarBEAT ® readings � � � 16 Cybersecurity Best Practice � � � � � � � � � � � � � � � � � 17 Smart Device Settings � � � � � � � � � � � � � � � � � � � � � � 19 When to remove your device � � � � � � � � � � � � � � � � � 20 Precautions � � � � � � � � � � � � � � � � � � � � � � � � � � � � 21 Labelling & Packaging of sugarBEAT ® � � � � � � � � � � � � � � � � 25 What is in your sugarBEAT ® Device Box? � � � � � � � � � � � � � � 26 Transmitter � � � � � � � � � � � � � � � � � � � � � � � � � 26 Docking Station � � � � � � � � � � � � � � � � � � � � � � � 26 Transmitter Password Card � � � � � � � � � � � � � � � � � � 27 Charger � � � � � � � � � � � � � � � � � � � � � � � � � � � 27 Quick Start Guide � � � � � � � � � � � � � � � � � � � � � � 27 What is in your sugarBEAT ® Sensor Kit Box? � � � � � � � � � � � � � 27 Sensor � � � � � � � � � � � � � � � � � � � � � � � � � � � 27 Guiding Frame � � � � � � � � � � � � � � � � � � � � � � � 28 3 The sugarBEAT ® Smart Device App � � � � � � � � � � � � � � � � � 28 Getting started with sugarBEAT ® � � � � � � � � � � � � � � � � � � 32 1� Charging the Transmitter � � � � � � � � � � � � � � � � � 32 2� Initial App Set- Up � � � � � � � � � � � � � � � � � � � � 33 3� Connect the Transmitter to the sugarBEAT ® App � � � � � � 37 4� Preparing your skin before attaching sugarBEAT ® � � � � � 41 5� Attaching the Sensor � � � � � � � � � � � � � � � � � � � 44 6� Placing the Transmitter on your Arm � � � � � � � � � � � 46 7� Calibrating the Transmitter � � � � � � � � � � � � � � � � 47 sugarBEAT ® ‘In-App’ Symbols and Settings � � � � � � � � � � � � 50 Battery Symbols � � � � � � � � � � � � � � � � � � � � � � 53 Review of Settings � � � � � � � � � � � � � � � � � � � � � � � 54 Alerts on the sugarBEAT ® App � � � � � � � � � � � � � � � � � � � 56 App Alerts: Low Limits � � � � � � � � � � � � � � � � � � � � 58 App Alerts: High Limits � � � � � � � � � � � � � � � � � � � 60 Glucose Trend Arrows � � � � � � � � � � � � � � � � � � � � 62 Time-in-Range (TIR) � � � � � � � � � � � � � � � � � � � � � 63 Viewing & Exporting Data � � � � � � � � � � � � � � � � � � � � � 65 Transmitter Removal + Storage � � � � � � � � � � � � � � � � � � 69 Everyday Use of the App / Transmitter � � � � � � � � � � � � � � � � 71 4 Diary Functions – Logging Food, Medication, Wellbeing and Activity � � 73 A� Activity � � � � � � � � � � � � � � � � � � � � � � � � � 73 B� Medication � � � � � � � � � � � � � � � � � � � � � � � 75 C� Food � � � � � � � � � � � � � � � � � � � � � � � � � � 76 D� Wellbeing � � � � � � � � � � � � � � � � � � � � � � � � 77 Troubleshooting � � � � � � � � � � � � � � � � � � � � � � � � � � � 79 A� Transmitter � � � � � � � � � � � � � � � � � � � � � � � 79 B� Application � � � � � � � � � � � � � � � � � � � � � � � 80 C� Docking Station / Charging � � � � � � � � � � � � � � � 85 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity � � � � � � � � � � � � � � � � � � � � 86 Electrical Safety testing and compliance � � � � � � � � � � � 87 IEC Classifications � � � � � � � � � � � � � � � � � � � � � � 87 Training � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 87 Additional Information � � � � � � � � � � � � � � � � � � � � � � 88 Specifications � � � � � � � � � � � � � � � � � � � � � � � � � � � � 89 A� sugarBEAT ® Specifications � � � � � � � � � � � � � � � � 89 B� sugarBEAT ® Sensor Specifications � � � � � � � � � � � � � 90 C� sugarBEAT ® Accuracy Specifications � � � � � � � � � � � � 91 Wireless Quality of Service Summary � � � � � � � � � � � � � � � 92 Wireless Security � � � � � � � � � � � � � � � � � � � � � � � � � � 94 Disposal of sugarBEAT ® Device and Sensor � � � � � � � � � � � � 94 Skin Care Tips � � � � � � � � � � � � � � � � � � � � � � � � � � � � 95 Manufacturer Contact Details � � � � � � � � � � � � � � � � � � � 95 5 Starting out with sugarBEAT ® sugarBEAT ® is for people with Type 2 diabetes or prediabetes who wish to have assistance with monitoring their glucose levels throughout their day sugarBEAT ® also works well for people who wish to monitor their glucose as part of a healthy lifestyle� This Instructions for Use covers your experience with the sugarBEAT ® device� It covers what the sugarBEAT ® device is and how to use it as well as how to download and use the sugarBEAT ® App� It is important to read all the Instructions for Use before you use sugarBEAT ® as it contains important information about the device� You should keep your Instructions for Use somewhere safe as you may need to refer to it again in the future� 6 Your sugarBEAT ® system Below is a brief summary of what the sugarBEAT ® system is and what it does� More detailed information is provided later in this guide� sugarBEAT ® is a non-invasive Continuous Glucose Monitoring (CGM) system for tracking glucose trends and patterns and is intended to help people with Type 2 diabetes and prediabetes better manage, reverse and prevent the onset of this condition� It can also be used by those who simply want to better understand the impact their lifestyle and diet is having on their glucose levels� sugarBEAT ® is intended to be complimentary to Self-Monitoring Blood Glucose (SMBG) testing for those with diabetes although everyone will nee…

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Monitoring System using Bluetooth LE External Photos 14-Oct-2022 FCC ID: 2A8VFAA

18.5 22.9 SEE NOTE 1. ISOMETRIC VIEW NOTES: PRINTED LOGO TO BE PLACED AT THE CENTRE1. SEE AI. FILE FOR PRINTING DETAILS INCLUDING COLOUR CODES2. FIRST ISSUE MARKING CHANGED REVISIONS REV.DESCRIPTIONDATEAPPROVED 0115/11/2021FC 0227/10/2022FC DWG NO: NEM51 - 288 TITLE: TECHNICAL REFERENCE: PROJECTION: MM SIZE: REVISION: 02 APPROVED STATUS: JASON AMBROSE-JONES MADE FROM: MATERIAL: FINISH: N/A WEIGHT: 1.9G PRINTED PRINTED BACK CASEWORK - sugarBEAT / MySugarWatch A4 UNITS: SCALE: 2:1 SHEET: 1 OF 1 C E D 6 5 2 34 1 APPROVED BY: THIS DOCUMENT AND DATA EMBODY PROPRIETARY INFORMATION WHICH IS THE CONFIDENTIAL PROPERTY OF NEMAURA PHARMA LIMITED AND SHALL NOT BE COPIED NOR REPRODUCED. THIS DOCUMENT AND DATA SHALL NOT BE DISCLOSED TO NON-NEMAURA PHARMA LIMITED PERSONNEL OR USED IN WHOLE OR IN PART FOR ANY PURPOSE WITHOUT THE EXPRESS WRITTEN PERMISSION OF NEMAURA PHARMA LIMITED. THIS DOCUMENT IS LOANED IN CONFIDENCE WITH THE UNDERSTANDING IT SHALL BE RETURNED ON DEMAND. 6 4 2 1 3 5 A B A B C E D NEM - 248 NEMAURA PHARMA LIMITED 5 OAKWOOD DRIVE LOUGHBOROUGH LEICESTERSHIRE LE11 3QF UNITED KINGDOM 7 7 DATE OF ISSUE: 15/11/2021 CREATED BY: RONI BENSIMON FAZ CHOWDHURY FM830-2 TECHNICAL DRAWING TEMPLATE SIZE A4_REV02

Monitoring System using Bluetooth LE Internal Photos 14-Oct-2022 FCC ID: 2A8VFAA Chip Antenna

UL International (UK) LTD Unit 1-3 Horizon, Kingsland Business Park, Wade Road, Basingstoke, Hampshire, RG24 8AH, UK Telephone: +44 (0)1256 312000 Facsimile: +44 (0)1256 312001 TEST REPORT Test Report No. : UL-RPT-RP14277658-416A Customer : Nemaura Pharma Limited Model No. : sugarBEAT FCC ID : 2A8VFAA Technology : Bluetooth – Low Energy Test Standard(s) : FCC Parts 15.209(a) & 15.247 Test Laboratory : UL International (UK) Ltd, Basingstoke, Hampshire, RG24 8AH, United Kingdom 1. This test report shall not be reproduced except in full, without the written approval of UL International (UK) Ltd. 2. The results in this report apply only to the sample(s) tested. 3. The sample tested is in compliance with the above standard(s). 4. The test results in this report are traceable to the national or international standards. 5. Version 2.0 supersedes all previous versions. Date of Issue: 12 December 2022 Checked by: Ben Mercer Lead Project Engineer, Radio Laboratory Company Signatory: Sarah Williams RF Operations Leader, Radio Laboratory The Bluetooth ® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by UL International (UK) Ltd is under licence. Other trademarks and trade names are those of their respective owners. TEST REPORT SERIAL NO: UL-RPT-RP14277658-416A VERSION 2.0 ISSUE DATE: 12 DECEMBER 2022 Page 2 of 31 Customer Information Company Name: Nemaura Pharma Limited Address: Advanced Technology Centre Oakwood Drive Loughborough Leicestershire LE11 3QF United Kingdom Report Revision History Version Number Issue Date Revision Details Revised By 1.0 17/10/2022 Initial Version Ben Mercer 2.0 12/12/2022 <30 MHz correlation statement added Ben Mercer TEST REPORT SERIAL NO: UL-RPT-RP14277658-416A VERSION 2.0 ISSUE DATE: 12 DECEMBER 2022 Page 3 of 31 Table of Contents Customer Information ...................................................................................................................... 2 Report Revision History ................................................................................................................... 2 Table of Contents .............................................................................................................................. 3 1 Attestation of Test Results ........................................................................................................... 4 1.1 Description of EUT 4 1.2 General Information 4 1.3 Summary of Test Results 5 1.4 Deviations from the Test Specification 5 2 Summary of Testing ...................................................................................................................... 6 2.1 Facilities and Accreditation 6 2.2 Methods and Procedures 6 2.3 Calibration and Uncertainty 7 2.4 Test and Measurement Equipment 8 3 Equipment Under Test (EUT) ...................................................................................................... 10 3.1 Identification of Equipment Under Test (EUT) 10 3.2 Modifications Incorporated in the EUT 10 3.3 Additional Information Related to Testing 11 3.4 Description of Available Antennas 11 3.5 Description of Test Setup 12 4 Antenna Port Test Results .......................................................................................................... 15 4.1 Transmitter Minimum 6 dB Bandwidth 15 4.2 Transmitter Maximum Peak Output Power 17 5 Radiated Test Results ................................................................................................................. 20 5.1 Transmitter Duty Cycle 20 5.2 Transmitter Radiated Emissions <1 GHz 22 5.3 Transmitter Radiated Emissions >1 GHz 24 5.4 Transmitter Band Edge Radiated Emissions 27 Annex A: Real World Duty Cycle ................................................................................................... 31 TEST REPORT SERIAL NO: UL-RPT-RP14277658-416A VERSION 2.0 ISSUE DATE: 12 DECEMBER 2022 Page 4 of 31 1 Attestation of Test Results 1.1 Description of EUT The equipment under test was a non-invasive glucose monitor containing a Bluetooth LE transceiver. 1.2 General Information Specification Reference: 47CFR15.247 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Intentional Radiators) – Section 15.247 Specification Reference: 47CFR15.209 Specification Title: Code of Federal Regulations Volume 47 (Telecommunications): Part 15 Subpart C (Intentional Radiators) – Section 15.209 Site Registration: 685609 Lab. Designation No.: UK2011 Location of Testing: Unit 3 Horizon, Wade Road, Kingsland Business Park, Basingstoke, Hampshire, G24 8AH, United Kingdom Test Dates: 30 August 2022 to 06 September 2022 TEST REPORT SERIAL NO: UL-RPT-RP14277658-416A VERSION 2.0 ISSUE DATE: 12 DECEMBER 2022 Page 5 of 31 1.3 Summary of Test Results FCC Reference (47CFR) Measurement Result Part 15.35(c) Transmitter Duty Cycle Note 1 Part 15.247(a)(2) Transmitter Minimum 6 dB Bandwidth Part 15.247(b)(3) Transmitter Maximum Peak Output Power Part 15.247(e) Transmitter Power Spectral Density Note 2 Part 15.247(d) & 15.209(a) Transmitter Radiated Emissions Part 15.247(d) & 15.209(a) Transmitter Band Edge Radiated Emissions Key to Results = Complied = Did not comply Note(s): 1. The measurement was performed to assist in the calculation of the level of the emissions. The EUT cannot transmit continuously and sweep triggering/signal gating cannot be implemented. 2. In accordance with ANSI C63.10 Section 11.10.1, PSD measurements are not required if the maximum conducted output power is less than the PSD limit of 8 dBm / 3 kHz. The PSD level is therefore deemed to be equal to the measured output power. 1.4 Deviations from the Test Specification For the measurements contained within this test report, there were no deviations from, additions to, or exclusions from the test specification identified above. TEST REPORT SERIAL NO: UL-RPT-RP14277658-416A VERSION 2.0 ISSUE DATE: 12 DECEMBER 2022 Page 6 of 31 2 Summary of Testing 2.1 Facilities a…

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2.4GHz Mini Antenna, SMTP/N 2450AT18A100 Detail Specification: Page 1 of 5 *Efficiency based on Johanson's standard evaluation board ±± ±± ±± www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver. 3.0 2018 Johanson Technology, Inc. All Rights Reserved "High Frequency Ceramic Solutions" Part Number 7/9/2018 Avg. Rad Efficiency* Let us help you with the antenna design, optimization, and tuning! 2450AT18A100 2400 - 2500 76% General Specifications Frequency (MHz) 18 months max. -40 to +125°C -40 to +125°C 3000 Return Loss (dB) Impedance Input Power Storage Period Storage Temperature Operating Temperature Reel Quantity 50 Ω 2 Watts max. (CW) Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. e.g. 2450AT18A100(E or S)100% Tin Packing Style Evaluation Board 2450AT18A100-EBSMA (see page 2&3 for details) Bulk (loose) T & R Suffix = E or S Suffix = E P/N Suffix Mechanical Dimensions In L 0.1260.0083.200.2 W 0.0630.0081.600.2 T 0.0511.30+.004/-.008 +0.1/-0.2 a 0.0200.0120.500.3 Terminal Configuration Function FEED NC No. 1 2 mm e.g. 2450AT18A100E e.g. 2450AT18A100SSuffix = S Part Number Explanation Peak Gain (dBi typ.) Average Gain (dBi typ.) 0.5 -0.5 9.5 min. ① ② L W a T Want the layout file? Request it at: www.johansontechnology.com/ask-a-question 2.4GHz Mini Antenna, SMTP/N 2450AT18A100 Detail Specification: Page 2 of 5 JTI P/N for Matching Circuit: Cap (1.0pF): 500R07S1R0BV4T Inductor (2.7nH): L-07C2N7SV6T Inductor (3.9nH): L-07C3N9SV6T www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver. 3.0 2018 Johanson Technology, Inc. All Rights Reserved "High Frequency Ceramic Solutions" 7/9/2018 Mounting Considerations 1: Evaluation Board Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. GND NO GND Units in mm ) ) 13.5mm 6.5mm 39.5mm 6.5mm 50Ω Feed Line Antenna 4mm ) Matching Component JTI P/Ns: L-14C2N7JV4 L-14C2N2JV4 * 2.6 4.2 1.6 1.9 0.4 2.7nH 1.0pF 3.9nH To order a pre-tuned 50Ω EVB with a female SMA connector click here: www.johansontechnology.com/request-a-sample Reference p/n: 2450AT18A100-EBSMA 2.4GHz Mini Antenna, SMTP/N 2450AT18A100 Detail Specification: Page 3 of 5 Return Loss with matching circuit @ +25CVSWR with matching circuit @ +25C and +125C www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver. 3.0 2018 Johanson Technology, Inc. All Rights Reserved "High Frequency Ceramic Solutions" 7/9/2018 Mounting Considerations 1: Typical Electrical Performance (T=25°C) Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. 2.4GHz Mini Antenna, SMT P/N 2450AT18A100 Detail Specification: Page 4 of 5 www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver. 3.0 2018 Johanson Technology, Inc. All Rights Reserved "High Frequency Ceramic Solutions" 7/9/2018 Mounting Considerations 1: Antenna Performance Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. Z X (0°) Y X (0°) Typical 2D radiation patterns @ 2.44GHz YZ-plane XZ-plane XY-plane Z (0°) Y XY cut @2.45GHz Vertical Horizontal XZ cut @2.45GHz Vertical Horizontal YZ cut @2.45GHz Vertical Horizontal 2.4GHz Mini Antenna, SMTP/N 2450AT18A100 Detail Specification: Page 5 of 5 www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver. 3.0 2018 Johanson Technology, Inc. All Rights Reserved Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. Soldering Information RoHS Compliance Packaging information For layout review contact our Applications Team at: "High Frequency Ceramic Solutions" Antenna tuning, optimization, and validation services: For more antennas and to download measured S-parameters, go to: MSL Info 7/9/2018 www.johansontechnology.com/ipc-antenna-services www.johansontechnology.com/antennas www.johansontechnology.com/ipcsoldering-profile www.johansontechnology.com/msl-rating www.johansontechnology.com/tape-reel-packaging www.johansontechnology.com/ask-a -question www.johansontechnology.com/rohs-compliance Need help designing the antenna in? Use our antenna design services! www.johansontechnology.com/ipc-antenna-services We provide 2 free layout reviews and if you need us to tune and characterize the antenna on your product (inside anechoic chamber) we can do that too. Small lab fee may apply for the latter.

Nemaura Pharma Limited FCC ID: 2A8VFAA UL-RPT-RP14277658-416A UL International (UK) Ltd 1 Test Setup Photographs for the sugarBEAT 1. Radiated Emissions 1.1. Configuration 1: Radiated Measurements < 30 MHz Photo 1 Photo 2 Nemaura Pharma Limited FCC ID: 2A8VFAA UL-RPT-RP14277658-416A UL International (UK) Ltd 2 Radiated Emissions (continued) 1.2. Configuration 2: Radiated Measurements from 30 MHz t o 1 GHz. Photo 1 Nemaura Pharma Limited FCC ID: 2A8VFAA UL-RPT-RP14277658-416A UL International (UK) Ltd 3 Radiated Emissions (continued) 1.3. Configuration 3: Radiated Measurements > 1 GHz. Photo 1 Nemaura Pharma Limited FCC ID: 2A8VFAA UL-RPT-RP14277658-416A UL International (UK) Ltd 4 2. Conducted Tests 2.1. Configuration 1: Conducted Tests Photo 1