D. DOT CGM User Manual

1. How to Use This Manual

Read this manual completely before using D. DOT CGM for the first time. This manual explains the sensor, applicator, D DOT App, warnings, precautions, app features, troubleshooting, reporting and warranty process for India.

• Read first: Safety information, contraindications, warnings and precautions, sensor application steps, and when to verify with a blood glucose meter.
• Keep available: Customer support contact, lot number and serial number, warranty request form, adverse event reporting instructions, and app permissions checklist.

2. Terminology

3. Product Overview

D. DOT CGM is a Continuous Glucose Monitoring System designed to continuously monitor glucose levels in interstitial fluid and provide real-time glucose information through the D DOT mobile application. The system consists of a disposable sensor, integrated transmitter and D DOT App. After activation and warm-up, the sensor measures glucose every 3 minutes and can provide up to 480 readings per day. Each sensor is designed for up to 14 days of continuous wear, subject to proper application, adhesion, storage, phone setup and system operation.

View real-time glucose readings and trend arrows. · Review glucose graphs and historical trends. · Receive high and low glucose alerts, subject to phone settings and app permissions. · Generate reports, including time in range and AGP-style summaries where supported.

Record meals, diet logs, hydration, medication, insulin events, activity, sleep, mood, stress, energy level, symptoms, menstrual logs and notes where supported.

Upload medical reports in PDF or image formats where supported and permitted by user consent.

View a health timeline of important events such as glucose highs/lows, missed medication, symptoms, exercise and report uploads.

Share selected data with family members, caregivers, loved ones or healthcare professionals after consent.

Access AI-generated report explanations, evidence-linked insights, trend summaries and health timeline summaries where supported.

4. Working Principle

The sensor electrode is inserted into interstitial fluid under the skin. Glucose in the interstitial fluid reacts with the sensor chemistry and generates an electrical signal. The built-in transmitter processes this signal and transmits sensor glucose readings to the D DOT App through Bluetooth. Interstitial fluid readings may lag blood glucose • CGM readings are not direct blood measurements. • During rapid glucose changes after meals, exercise, insulin, illness or hypoglycemia, sensor glucose may differ from blood glucose meter values. • When symptoms do not match the app reading, use a fingerstick blood glucose meter and follow medical advice.

5. Product Components

Component Type Description Applicator Disposable, sterile, single-use Used to apply the sensor onto the abdomen or back of the upper arm. Do not reuse. Sensor Single-use, up to 14 days All-in-one sensor with adhesive patch, sensor electrode and built-in transmitter. Integrated transmitter Built into sensor Wirelessly sends sensor glucose readings to the D DOT App via Bluetooth. D DOT App Mobile application Displays glucose values, trends, alerts, logbook, reports and permitted sharing/AI features. reverse side.]

6. D DOT Application Overview

The D DOT App is a mobile medical application used with D. DOT CGM. It receives sensor data, processes glucose readings and displays readings, trend curves, trend arrows, sensor status, alerts, reports and supported app features. Requirement Details Operating system Android 9.0 and above / iOS 13.2 and above, or as updated in the app store compatibility list. Connection One app/device should connect to one active sensor at the same time unless a permitted sharing feature is used. Data transmission Sensor and app transmit data via Bluetooth protocol. Data export Excel, PDF or other formats depending on app version and released functionality. Internet May be required for login, cloud backup, sharing, AI reports, app updates and document upload features. 6.1 D DOT Health Intelligence Platform Features In addition to glucose display, the D DOT App may combine CGM data, user-entered logs, uploaded medical reports and sharing permissions to provide a broader health-intelligence experience. Feature availability may vary by app version, regulatory release stage and user permissions. Feature area What it may support CGM glucose data Real-time sensor glucose, glucose trends, alerts, glucose history and CGM status. Medication adherence Medication schedules, taken doses, missed doses and adherence percentage where supported. Insulin tracking Insulin event logging where supported. The app does not recommend insulin dose changes. Activity tracking Steps, exercise sessions, activity consist

7. Safety Information

Incorrect use of the system may lead to inaccurate readings, missed alerts or wrong interpretation of glucose data. Always follow this manual, the app instructions and guidance from your healthcare professional. Safety area Instruction Do Read this manual, prepare the skin properly, keep the phone within range, keep alerts enabled and verify with a blood glucose meter when symptoms do not match readings. Do not Do not reuse the sensor, use expired sensors, use damaged packaging, modify the device, ignore severe symptoms, or make medication/insulin decisions based only on app or AI output. Ask your doctor How to set alert thresholds, how to respond to low/high glucose alerts, when to use a blood glucose meter and how to use CGM reports in your care plan.

8. Intended Use, Users and Environment

8.1 Intended use D. DOT CGM is intended for continuous or periodic recording of glucose levels in interstitial fluid for adults with diabetes aged 18 years or older. The information is intended to detect glucose trends and track glucose patterns to provide reference information to patients and healthcare professionals for diabetes management. The system provides real-time sensor glucose values through the D DOT App. It is not intended to diagnose diabetes, replace professional medical judgment, or independently determine treatment decisions. 8.2 Intended users Intended users include healthcare professionals, patients and family members or caregivers of patients aged 18 years and above. Users must be able to understand the instructions, maintain hygiene, identify body parts and operate the app safely. Patients with disabilities may need assistance. 8.3 Intended environment The system is intended for use in home healthcare environments and professional healthcare facility environments. 8.4 Indications · Type 1 and Type 2 diabetes mellitus. · Special types of diabetes, excluding monogenic diabetes syndromes, diseases of the exocrine pancreas, and drug or chemical induced diabetes unless specifically advised by a healthcare professional.

Abnormal glucose levels requiring monitoring. · Patients requiring improved glycemic control. · People requiring frequent or continuous monitoring of glucose. 8.5 Application site and reuse Approved application sites are the abdomen and the back of the upper arm. D. DOT CGM sensor and applicator are single-use products. Do not reuse, re-sterilize or share the sensor or applicator.

9. Contraindications, Warnings and

Precautions 9.1 Contraindications · Because part of the sensor pierces the skin, people with delicate skin should use the device cautiously and seek medical advice if needed.

Remove the sensor before MRI, CT scan or diathermy treatment unless the healthcare provider and approved device instructions specifically confirm safe use.

Taking higher than the maximum recommended dose of acetaminophen/paracetamol may affect CGM readings and may make readings appear higher than they really are.

The system was not evaluated for pregnant women, peritoneal dialysis patients, patients with implanted pacemakers, patients with coagulation disorders or those taking anticoagulant drugs. 9.2 Warnings · Do not use the system if you have diffuse subcutaneous nodules at the intended application site.

Read instructions thoroughly before use. Incorrect use may lead to misunderstanding of the information or missed low/high glucose events.

Talk to a healthcare professional about how to use CGM glucose information for diabetes management.

If alerts or readings do not match symptoms or expectations, use a fingerstick blood glucose meter to make treatment decisions and seek medical attention when appropriate.

After restarting the phone or enabling airplane mode, confirm that Bluetooth is turned on and the D DOT App can communicate with the sensor.

Do not use if sterile packaging is damaged, opened or expired. · Keep small parts away from children. Small parts may cause choking if swallowed. · Keep the system away from strong electromagnetic fields that may interfere with Bluetooth communication. 9.3 Precautions · No modifications are allowed. Unauthorized modification may cause malfunction and may void warranty.

Read this manual or receive training before use. · Rapid glucose changes may cause sensor glucose to differ from fingerstick blood glucose.

Severe dehydration or excessive water loss may result in inaccurate readings. · If the sensor becomes loose, readings may be unavailable or unreliable. · The product is waterproof to 1 meter for up to 120 minutes. Do not exceed this limit. · Clean and dry skin before application. Do not apply until alcohol has fully dried. · Change the insertion site each time to reduce irritation and allow the skin to heal. · Intense exercise, sweat, friction or impact may loosen the sensor. · Users are responsible for securing their phone and app account to prevent unauthorized access.

10. Risks and Clinical Benefits

10.1 Potential risks Risk Description Inaccurate readings May occur due to rapid glucose changes, dehydration, compression, medication interference, sensor issue, expired product or improper storage. Skin reaction May include redness, itching, rash, bleeding, discomfort, adhesive allergy or infection at the insertion site. Missed alerts May occur if phone battery is low, Bluetooth is off, app permissions are disabled, phone is out of range, Do Not Disturb is active or the app is closed. Sensor detachment May occur due to poor skin preparation, friction, sweat, impact, swimming beyond specifications or adhesive issue. Broken sensor tip Rarely, the sensor tip may break and remain under the skin. Do not attempt to remove it yourself. Seek medical help. 10.2 Potential clinical benefits · Improved visibility of glucose trends and patterns. · Better review of time in range and glucose variability with healthcare professionals. · Reduced time spent in hypoglycemia or hyperglycemia when alerts and treatment plans are used appropriately.

More informed diabetes management discussions with doctors, diabetes educators and caregivers. Benefit depends on proper use • CGM benefit is strongest when users respond appropriately to alerts, verify readings when needed and review reports with healthcare professionals. • The system cannot prevent glucose events by itself. User action and clinical guidance are still required.

11. Installation Requirements

Before using D. DOT CGM, confirm that you have a compatible smartphone, the D DOT App, stable Bluetooth, notification permissions, a clean application site and a blood glucose meter available for verification when needed. Requirement Instruction Phone battery Keep the phone charged. Low battery may cause missed alerts or disconnection. Bluetooth Keep Bluetooth enabled during sensor use. Distance Keep the phone within 6 m of the sensor without major obstruction whenever possible. Notifications Allow app notifications and critical alerts where supported. Background activity Allow the app to run in the background. Do not force close the app during sensor use. Internet Required for features such as login, sharing, cloud sync, AI reports and app updates where enabled. Blood glucose meter Keep a meter available to confirm readings when symptoms do not match CGM values.

12. Smartphone and App Setup

12.1 App installation 1. Download the D DOT App from Google Play Store or Apple App Store, as applicable. 2. Install the app and complete account setup and personal information fields as requested. 3. Select the glucose unit: mmol/L or mg/dL. 4. Set the target glucose range and alarm/alert preferences in consultation with your healthcare professional.

requested by the app where required for operation.

features. 12.2 Phone settings checklist Setting Recommended status Bluetooth On Notifications Allowed for D DOT App Background refresh / background data Allowed Battery optimization / deep sleep Disabled for D DOT App where possible Do Not Disturb Disabled or configured to allow critical glucose alerts Silent / mute mode Avoid relying only on sound if phone settings may block sound Operating system update After every update, reopen the app and verify Bluetooth and notification permissions Warning • If phone settings are not configured correctly, you may miss high or low glucose alerts. • No app can guarantee delivery of every alert under all phone, operating system, battery, network or Bluetooth conditions.

• 5. Allow Bluetooth, notification, camera, background refresh and other permissions
• 6. Review consent settings before enabling sharing, cloud backup, document upload or AI

13. Sensor Application

13.1 Check sensor before use · Check the package, expiration date, batch/lot number, serial number and tamper-evident label.

Do not use if the applicator, cap, packaging or tamper-evident label is damaged or opened.

Do not use if expired. · Keep the package closed until ready to apply. 13.2 Select application site The D. DOT CGM can be worn on the back of the upper arm or abdomen. Select a flat area less likely to be pressed, rubbed or bumped.

Avoid a site where a CGM was recently worn. · Avoid loose skin, muscle areas, bony areas or areas with insufficient fat. · Avoid areas within 5 cm of insulin injection or infusion sites. · Avoid damaged skin, irritation, scars, tattoos, moles or excessive hair. · Avoid the waistline, belt area or places likely to be pressed during sleep. · Keep abdomen placement at least 5 cm away from the navel. · If pregnant, avoid abdomen placement unless specifically advised by a healthcare professional. 13.3 Clean application site 1. Wash your hands with soap and water and dry them. 2. Clean the selected application site with soap and water if needed and dry fully. 3. Wipe the site with an alcohol wipe. 4. Allow the skin to dry completely before applying the sensor. 5. Make sure the site is free of lotions, perfumes, oils, medication, sweat or moisture. 13.4 Apply sensor 1. Rotate/open the product casing according to the applicator design. 2. Do not touch the sensor needle or inside of the applicator. 3. Place the applicator on the selected site. 4. Press downward with firm vertical force. 5. After hearing a click, wait 3 to 5 seconds. 6. Gently remove the applicator vertically. 7. After application, gently press the sensor and surrounding adhesive tape to improve adhesion. 8. Dispose of the used applicator safely. Minor bleeding may occur during application. Minor bleeding does not always affect monitoring. If bleeding is heavy, painful, persistent or concerning, remove the sensor and s

14. Starting Monitoring

15. Understanding Glucose Readings

The D DOT App displays current sensor glucose value, trend arrow, glucose curve and CGM status. The exact screen layout may vary by app version. 15.1 Sensor glucose range The sensor glucose display range is 2.2 to 22.2 mmol/L. Values below or above this range may be displayed as out-of-range readings or handled by the app according to design, while records may still appear in logbook depending on app behavior. 15.2 Trend arrows Trend arrow Definition Stable Glucose is stable, no more than 0.06 mmol/L rise or fall per minute. Slow increase Glucose increases by 0.06 to 0.11 mmol/L per minute. Increase Glucose increases by 0.11 to 0.17 mmol/L per minute. Rapid increase Glucose increases by more than 0.17 mmol/L per minute. Slow decrease Glucose decreases by 0.06 to 0.11 mmol/L per minute. Decrease Glucose decreases by 0.11 to 0.17 mmol/L per minute. Rapid decrease Glucose decreases by more than 0.17 mmol/L per minute. No arrow The app cannot calculate rate of change because of synchronization, disconnection or insufficient recent data. 15.3 When to verify with a blood glucose meter · When symptoms do not match the app reading. · When glucose is changing quickly. · During warm-up or system recovery. · When the app shows no reading, link lost or sensor error. · Before making treatment decisions when readings are unexpected. · Any time your healthcare professional advises meter confirmation.

16. Alerts and Notifications

The app provides urgent low, low and high glucose alerts using sounds, vibration, display and notifications depending on phone settings, app permissions and operating system behavior. Alarm Introduction Threshold setting Default Low Alarm If sensor glucose is lower than this value, the app gives a hypoglycemia alarm. 3.3 to 5.6 mmol/L (60 to 101 mg/dL) 3.9 mmol/L (71 mg/dL) Urgent Low If sensor glucose is at or below this value, the app gives an urgent hypoglycemia alarm. 3.1 mmol/L (56 mg/dL) 3.1 mmol/L (56 mg/dL) High Alarm If sensor glucose is higher than this value, the app gives a hyperglycemia alarm. 7.9 to 22.2 mmol/L (143 to 400 mg/dL) 13.0 mmol/L (234 mg/dL) Snooze: Users may turn off the current alarm or snooze the alarm according to app settings. Do not ignore repeated alarms. Confirm glucose with a blood glucose meter if needed. 16.1 Alert reliability responsibilities Area Instruction User responsibility Keep phone charged, Bluetooth enabled, app running in background and notifications allowed. App limitation Alerts may not be delivered if phone, app, Bluetooth, operating system, battery or permission settings block operation. Clinical responsibility Discuss alert thresholds and response plans with a healthcare professional.

17. Event Logging and Health Timeline

The app may allow users to record events that help explain glucose patterns. Event entries are user-provided and may be inaccurate, incomplete or delayed. They should be used as context, not as medical advice. Event type Purpose and limitation Meals / carbohydrates Record meal timing, food notes, photos or carbohydrate information where supported. Medication Record medication schedules, taken doses, missed doses and adherence percentage. The app does not recommend medicine changes. Insulin Record insulin events where supported. The app does not recommend insulin doses. Exercise / activity Record exercise type, timing, duration, steps or activity consistency where supported. Hydration Record water intake and hydration context where supported. Hydration scores are wellness indicators, not diagnoses. Sleep Record sleep duration, sleep quality, sleep consistency or recovery context where supported. Mood, stress and energy Record mood, stress and energy levels to help review lifestyle context. Symptoms Record symptoms such as dizziness, sweating, fatigue, nausea or other user-selected symptoms where supported. Menstrual tracking Record menstrual cycle context where supported. Medical report upload Upload lab reports, prescriptions, discharge summaries or imaging reports where supported. OCR and AI explanation may be available. Health profile Store basic profile data to support display and report personalization where supported. 17.1 Health Timeline The health timeline may show imp

18. Reports, AGP, Health Score and Time

in Range Reports may include daily glucose reports, Ambulatory Glucose Profile (AGP), time in range, trend summaries, glucose variability and exportable summaries. Reports require sufficient valid data. Some charts may require at least 24 hours of valid sensor data. Report type Description Time in Range Shows the percentage of time sensor glucose readings are within a selected target range. AGP-style report Summarizes glucose patterns over time to support review with healthcare professionals. Daily / weekly / monthly reports May show glucose curves, alerts, event context, weekly summaries and monthly summaries where supported. Glucose performance May include time in range, high glucose episodes, low glucose episodes, daily variability, weekly trends, best control days and worst control days. Medication impact May include adherence score, missed days, taken doses, correlation with glucose control and potential risk periods where supported. Sleep impact May include average sleep quality, sleep consistency, sleep debt and possible relationship to glucose patterns where supported. Stress and mood impact May include stress trends, high-stress periods and glucose changes during stress where supported. Activity impact May include average steps, exercise frequency and activity consistency where supported. Hydration insights May include water intake, dehydration-risk context and wellness impact where supported. Symptom intelligence May include common symptoms, severity trends and poss

19. AI Health Coach, AI Reports and

Evidence-Based Insights The D DOT App may provide AI Health Coach-style conversations, AI-generated reports, trend summaries and plain-language explanations based on available glucose data, user-entered events and uploaded documents where supported. AI outputs are intended to make data easier to understand, not to replace a doctor. AI feature User manual description AI Health Coach May answer questions about the user's own glucose readings, medication logs, lifestyle habits, wellness logs and uploaded records where supported. It must not be positioned as a doctor. Example questions Why was my glucose high yesterday? Is stress affecting my glucose? What habits appear linked with better control? These answers are informational and should be verified clinically. Evidence-based reports Insights may include traceable references to CGM data, medication logs, sleep logs, activity data, hydration logs, symptoms, menstrual logs or medical reports where supported. Medical report understanding The app may use OCR and AI to explain lab reports, prescriptions, discharge summaries or imaging reports in simple language. It must not provide diagnosis or treatment changes. Health correlation engine The app may identify associations such as poor sleep with glucose spikes, stress with hyperglycemia, exercise with glucose stability, hydration with wellness scores, or medication adherence with glucose outcomes. Risk pattern detection The app may highlight patterns such as high glucose, low glucos

20. Family, Caregiver and Loved-One

Sharing Users may authorize selected family members, caregivers, loved ones, friends or healthcare providers to view selected health information through approved application features. Sharing may include current glucose values, alerts, trends, wellness updates, reports, AI summaries and selected events depending on app version and consent settings. Sharing area Instruction Consent required Sharing should be enabled only after user authorization in the app. Access control Users should review who has access and revoke access when no longer needed. Live view where supported Recipients may view live glucose readings, glucose trends, critical high/low glucose events, medication adherence, wellness updates, AI reports and emergency alerts where supported. Not emergency monitoring Family sharing is supportive only and should not be relied on as an emergency monitoring service. Recipient responsibility Family members/caregivers should not change treatment unless instructed by the user’s healthcare professional.

21. Doctor Collaboration and Report

Sharing Users may securely share glucose reports, medical records, health timelines, medication adherence summaries, AI-generated summaries and historical data with healthcare professionals. Shared information may assist healthcare professionals in reviewing glucose patterns and supporting treatment discussions.

Share reports only with trusted healthcare professionals. · Confirm recipient identity before sharing. · Review what data is being shared and for what time period. · Shared data may include CGM trends, medication adherence reports, AI-generated health summaries, medical records, lifestyle insights and progress reports where supported.

Doctor sharing can make consultations more informed, but it does not guarantee faster treatment, real-time review or emergency response.

Treatment decisions remain between the user and qualified healthcare professionals.

22. Data Privacy and Consent in the App

The D DOT App may process sensitive personal information and health data. Users should read the D DOT User Agreement, Privacy Policy, Consent for Health Data Processing, Doctor Data Sharing Consent, Family/Caregiver Sharing Consent and AI Disclosure Statement before enabling optional features. Data area Instruction Core CGM use Glucose data, sensor details, alerts and logbook information required for device operation. Optional app features Family sharing, doctor sharing, AI reports, document upload, meal tracking and other app features may require separate permissions or consent. User control Users should be able to manage permissions, sharing and account settings in the app where supported. Security responsibility Users must secure the phone, account, password, OTP and app access. Do not share login credentials. Policy reference This manual is not a full privacy policy. The privacy policy and consent documents control data processing terms.

23. Calibration and Blood Glucose Meter

Verification The D. DOT CGM is factory calibrated. The app workflow may allow or request meter-based calibration in specific circumstances. Follow the app instructions and this manual. Topic Instruction Calibration range 2.2 to 22.2 mmol/L. Timing Enter the exact blood glucose meter value within the permitted app time window. Do not calibrate During rapid glucose change, system recovery, sensor warm-up, syncing or when app does not allow calibration. Meter verification Use a blood glucose meter when symptoms do not match CGM readings or when readings appear unexpected. Treatment decisions When unsure, follow healthcare professional guidance and confirm with a meter.

24. Sensor Removal and Disposal

24.1 Sensor removal 1. Remove the sensor when the 14-day session ends, when instructed by the app, when advised by a healthcare professional, or if severe skin irritation occurs. 2. Carefully peel the adhesive patch from the edge. 3. Do not pull suddenly. Remove slowly to avoid skin injury or discomfort. 4. If adhesive residue remains, gently clean with soap and water or an alcohol swab. 5. Check the site. Contact a healthcare professional if redness, swelling, pain, discharge, fever or signs of infection occur. 24.2 Disposal Dispose of the used sensor and applicator according to local rules for electronic waste and medical waste. Since parts of the sensor may contact bodily fluids, wipe the removed sensor with alcohol or disinfectant before disposal. Do not incinerate the sensor. The sensor contains a non-removable battery and burning it may be hazardous.

25. Troubleshooting

Issue Possible cause Solution Sensor adhesive not sticky or sensor fallen off Skin not clean/dry, hair, lotion, sweat, wrong site, friction or adhesive intolerance. Clean skin with soap/water and alcohol wipe before application. Allow skin to dry fully. Avoid tattoos, scars, oily skin and waistline. Use approved overpatch or tape around the adhesive if recommended. System stopped, please change sensor Sensor failure, expired sensor, improper activation or end of session. Check expiry and app instructions. Remove and replace sensor if instructed. Contact support with lot number, serial number and screenshots. Connecting, please wait Bluetooth off, phone too far, app closed, compatibility issue or interference. Turn Bluetooth on, move phone within 6 m, reopen app, restart phone if needed and remove sources of interference. System recovering, please wait Temporary sensor/system recovery period. Use a blood glucose meter during this period. If it does not recover after about 4 hours, contact support. Calibration error Syncing, recovery, first 24 hours, rapid glucose fluctuation or invalid meter value. Wait until glucose is stable and app allows calibration. Enter exact meter value within the permitted time.

26. Maintenance and Travel

26.1 Maintenance The D. DOT CGM sensor has no serviceable parts and requires no maintenance. Do not attempt to repair, open, modify, recharge, re-sterilize or reuse the sensor or applicator. 26.2 Travel Wearing the sensor is generally safe while passing through metal detectors. If concerned, inform security personnel that you are wearing a continuous glucose monitoring sensor and request visual inspection or alternative screening where permitted. Carry extra sensors, blood glucose meter supplies, charging accessories and relevant medical documents when traveling.

27. Product Performance

Item Specification Model D3 Measurement range 2.2 to 22.2 mmol/L Effective working time Up to 14 days Sensor size 24 mm diameter x 3.5 mm Sensor weight 1.7 g Data receiving range Up to 6 m without obstruction Calibration method Factory calibration. App workflow may allow or request meter-based calibration as applicable. Calibration range 2.2 to 22.2 mmol/L Storage and transport conditions Temperature: 2 °C to 30 °C. Relative humidity: 15% to 85%. Working conditions Temperature: 10 °C to 40 °C. Relative humidity: 10% to 95%. Atmospheric pressure 70 kPa to 106 kPa Sterile state Sterile Sterilization method Irradiation sterilization, gamma ray Validity period 12 months Display interval 3 minutes Rated voltage d.c. 1.5 V Classification Type BF applied part Power support Internal power supply Protection grade IP28, waterproof to 1.0 meter for up to 120 minutes Wireless Bluetooth 5.0, 2402 to 2480 MHz, GFSK, 0 dBm

28. EMC Statement

The D. DOT CGM is suitable for use in the specified electromagnetic environments and has met applicable emission and immunity requirements listed below. Higher interference levels may cause essential performance to be lost or degraded. 28.1 Electromagnetic emissions Phenomenon Home healthcare or professional healthcare facility environment Conducted and radiated RF emissions CISPR 11, Group 1, Class B Harmonic distortion N/A Voltage fluctuations and flicker N/A 28.2 Electromagnetic immunity Phenomenon Basic EMC standard Immunity test level Electrostatic discharge IEC 61000-4-2 +/- 8 kV contact; +/- 2, +/- 4, +/- 8, +/- 15 kV air Radiated RF EM fields IEC 61000-4-3 10 V/m, 80 MHz to 2.7 GHz, 80% AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000-4-3 See RF wireless communication equipment table. Rated power frequency magnetic fields IEC 61000-4-8 30 A/m; 50 Hz or 60 Hz Electrical fast transients/bursts IEC 61000-4-4 N/A Surges IEC 61000-4-5 N/A Conducted disturbances induced by RF fields IEC 61000-4-6 N/A Voltage dips / interruptions IEC 61000-4-11 N/A 28.3 Recommended Minimum Separation Distances Test freq. MHz Band MHz Service Modulation Max W Distance m Level V/m 385 380 to 390 TETRA 400 Pulse modulation 18 Hz 1.8 0.3 27 450 430 to 470 GMRS 460 / FRS 460 FM, +/- 5 kHz deviation 2 0.3 28 710 / 745 / 780 704 to 787 LTE Band 13, 17 Pulse modulation 217 Hz 0.2 0.3 9 810 / 870 / 930 800 to 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 P

29. Regulatory Information, India

Regulatory / labeling item Information Medical device licensed under CDSCO Not Available as of now Import license number Not Available as of now Device classification Class C Medical Device UDI details Not Available as of now Importer license details Not Available as of now Lot / batch number Refer to product packaging Serial number Refer to product packaging Imported and marketed by Dexvia Healthcare Private Limited, 3rd Floor, Sreshta Primus, Road No 36, Jubilee Hills, Hyderabad, Telangana - 500033, India Customer care +91 800 800 2041 / support@ddot.health Regulatory release requirement • Your regulatory consultant should provide the exact CDSCO license, import license, importer license and UDI details. • Do not print or distribute this manual commercially with placeholders unless legally permitted by the applicable approval stage. • IFU, labels, app wording and carton content should match the approved regulatory submission.

30. Technical Support and Customer

Service Contact item Details D. DOT Customer Support +91 800 800 2041 Email support@ddot.health Website www.ddot.health Company Dexvia Healthcare Private Limited Address 3rd Floor, Sreshta Primus, Road No 36, Jubilee Hills, Hyderabad, Telangana - 500033, India Manufacturer Infinovo Medical Co., Ltd. Manufacturer address 3rd Floor, 6th Building, No.888, Zhujiang Road, Rudong, 226400 Jiangsu, P.R. China Manufacturer telephone +86 (513) 81900808

31. Reporting Serious Incidents

In the event of a serious incident involving D. DOT CGM, report it immediately to D. DOT Customer Support. Where applicable, medical device adverse events may also be reported through the Materiovigilance Programme of India and applicable CDSCO reporting channels. Reporting contact Details D. DOT Customer Support +91 800 800 2041 Email support@ddot.health Company Dexvia Healthcare Private Limited India reporting route Materiovigilance Programme of India and applicable CDSCO medical device adverse event reporting channels A serious incident includes any occurrence that has caused, might have caused or could potentially cause death, serious injury, hospitalization, significant temporary or permanent deterioration in health, permanent impairment, or serious device malfunction. 31.1 Information to provide when reporting · Product name and model. · Sensor lot number, serial number and expiry date. · Date of purchase and seller details. · Date and time of incident. · Description of the event or malfunction. · App screenshots, error messages or photos of the sensor/packaging where available. · Medical outcome and whether healthcare support was required. · Customer name and contact details.

32. Warranty and Indian Replacement

Process 32.1 Warranty period Recommended warranty period: 12 months from date of purchase for manufacturing defects in materials and workmanship under normal use conditions, subject to the final warranty policy approved by Dexvia Healthcare Private Limited. The D. DOT CGM sensor is a single-use consumable product intended for up to 14 days of wear. Replacement eligibility may apply to confirmed device malfunction, defective applicator, sensor failure before completion of intended wear, or other verified manufacturing defect. 32.2 Indian replacement process 1. Contact D. DOT Customer Support at support@ddot.health or +91 800 800 2041. 2. Provide customer name, phone number, purchase invoice, seller name, purchase date, product model, batch/lot number, serial number and app screenshots where relevant.

whether warm-up completed and whether an app error message appeared.

evidence or additional checks are required.

details or the used/unused device for inspection. 6. If eligible, a replacement may be provided according to the company replacement policy. 7. If not covered, the customer will be informed of the reason and available options. 32.3 Warranty exclusions · Use outside this manual or approved labeling. · Use after expiry date. · Damage caused by accident, misuse, abuse, neglect, improper storage, improper application or unauthorized modification.

Opening, tampering, repairing, reusing or re-sterilizing the product. · Loss of data due to phone damage, app deletion, account misuse, user error or failure to maintain backups where applicable.

Use with unsupported phones, rooted/jailbroken phones or phones with unauthorized operating system modifications.

Cosmetic damage that does not affect product performance. · Sensor detachment caused by improper skin preparation, excessive friction, excessive sweating, impact, swimming beyond specifications or failure to follow instructions.

Adverse skin reaction not caused by product quality defect, unless replacement is approved by customer support as a policy exception. 32.4 Limitation of liability Except where prohibited by law, Dexvia Healthcare Private Limited and/or the manufacturer will not be liable for special, indirect, incidental or consequential damages arising from misuse, unsupported use, unauthorized modification, or failure to follow this user manual. This warranty does not limit statutory consumer rights that cannot be excluded by law.

• 3. Describe the fault clearly, including when it occurred, whether the sensor was applied,
• 4. Do not discard the product until customer support confirms whether return, photo
• 5. Customer support will review the issue and may request photos, app logs, packaging

33. Label Symbols

Symbol description Meaning Refer to instructions for use Read the user manual before using the product. Do not reuse Single-use product. Do not reuse. Do not use if package is damaged Do not use if sterile packaging is damaged or opened. Type BF applied part Applied part classification. Medical device Indicates the product is a medical device. Temperature limit Store within specified temperature range. Humidity limitation Store within specified humidity range. Non-ionizing radiation Wireless communication symbol. Sterilized using irradiation Sterilization method is irradiation. Date of manufacture Manufacturing date. Keep dry Protect from moisture. Keep away from sunlight Protect from direct sunlight. Manufacturer Manufacturer information. Caution Read warnings and precautions. Batch code Batch or lot number. Use-by date Expiry date. Unique device identifier UDI, to be updated once available. Model number Product model. Country of manufacture Country where manufactured. Do not re-sterilize Do not re-sterilize the product. Dustproof and waterproof class Ingress protection grade. Catalogue number Product catalogue/reference number. Serial number Product serial number. Environmental protection Dispose according to local e-waste and medical waste rules.

34. Appendix: Warranty Card and

Replacement Request Form Field Customer / support entry Customer name Contact number Email address Contact address Product name D. DOT CGM Product model D3 Date of purchase Seller / pharmacy / platform name Invoice number Sensor LOT / batch number Serial number Date of issue / malfunction App error message, if any Fault description Photos / screenshots attached Yes / No Support ticket number Replacement status Customer declaration: I confirm that the information provided above is accurate to the best of my knowledge and that the product was used according to the D. DOT CGM User Manual. Customer signature: ___________________________ Date: ___________________________