FCC ID: ADU-HM312 RIGHTEST Continuous Glucose Monitoring System (CGMS)

BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 E-mail: info@bionime.com http://www.bionime.com Emergo Europe Prinsessegracht 20 2514 AP The Hague The Netherlands Email: EmergoVigilance@ul.com 1 0

1 2 0 2

e t a D

. v e R 0 1 0

2 1 3 M H 3

1 0 1 N E Continuous Glucose Monitoring System

(HM312) User Manual Use with a receiver (HR310) READ THIS FIRST :

It is important to read the entire contents of this manual before using the RIGHTEST Continuous Glucose Monitoring System. The instructions, warnings, precautions, safety information as well as tips contained within this manual are intended to help ensure proper use and optimal results. It is important that you read this entire manual before using the system for the first time. 2 I. INDICATIONS FOR USE & STATEMENT AND ADVISORY INDICATIONS FOR USE STATEMENT AND ADVISORY II. SAFETY INFORMATION III. SYMBOL DEFINITIONS IV. GETTING TO KNOW YOUR RIGHTEST CGMS WHAT IS INCLUDED PERFORMANCE FEATURES SAFETY FEATURES THE RIGHTEST CGMS COMPONENTS ACCESSORIES V. BEFORE GETTING STARTED CHARGING BASICS CHARGING THE RECEIVER BATTERY LIFE INDICATOR ON THE RECEIVER CHARGING TRANSMITTER CONTENTS 6 6 6 7 14 16 16 18 19 20 21 22 22 23 26 27 3 COTENTS VI. SET UP YOUR RIGHTEST CGMS PAIRING THE SENSOR AND TRANSMITTER USING NFC APPLY YOUR SENSOR ATTACH YOUR TRANSMITTER CONNECT TRANSMITTER WITH RECEIVER VII. ENDING A MONITORING SESSION END THE MONITORING SESSION SENSOR AND TRANSMITTER REMOVAL VIII.UNDERSTAND YOUR GLUCOSE READINGS HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW GLUCOSE INFORMATION GLUCOSE TREND ARROW AND ARROW COLOR TREND GRAPH ADD NOTES ACCESS YOUR NOTES INFORMATION HIGH/LOW READING IX. REVIEW YOUR GLUCOSE HISTORY 4 32 32 42 46 50 54 56 58 60 60 62 64 66 68 70 72 74 CONTENTS X. CALIBRATION (OPTIONAL) CALIBRATE XI. TREATMENT DECISIONS WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS TREND ARROWS AND TREATMENT DECISIONS XII. RIGHTEST CGMS SPECIFICATIONS SENSOR INSERTER SPECIFICATIONS TRANSMITTER SPECIFICATIONS RECEIVER SPECIFICATIONS TRANSMITTER CHARGER SPECIFICATIONS XIII.CERTIFICATE STATEMENT RF STATEMENT FCC STATEMENT NCC STATEMENT XIV.APPENDIX: ALARM/ALERTS RECEIVER : GLUCOSE AND SIGNAL LOSS ALERTS XV. APPENDIX: CUSTOMER INFORMATION CUSTOMER SERVICE WARRANTY 76 77 80 82 84 88 88 90 92 94 96 96 96 98 100 100 118 118 118 5 Indications for Use & Statement and Advisory Safety Information I. INDICATIONS FOR USE & STATEMENT AND ADVISORY II. SAFETY INFORMATION INDICATIONS FOR USE The RIGHTEST Continuous Glucose Monitoring System (hereafter referred to as the "RIGHTEST CGMs") is indicated for detecting glycaemia trends and for the management of diabetes in persons age 18 to 80. It's an applied part and it is designed to replace blood glucose testing for diabetes treatment decisions. Interpretation of the RIGHTEST CGMs results shall be based on the glucose trends and several sequential readings over time. It also aids detecting episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The RIGHTEST CGMs is also intended to autonomously interface with digitally connected devices. The RIGHTEST CGMs can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. STATEMENT AND ADVISORY This manual is designed to instruct all personnel responsible for the proper use and care of the RIGHTEST CGMs. All users are urged to carefully read this manual before using the system. The following is a summary of safety information which must be observed before using the RIGHTEST CGMs. WARNING indicates potential danger to user. PRECAUTION indicates potential injury to the user or damage to the system. To minimize risks, read the following safety information before using the system. Improper use and maintenance may damage the system resulting in failure or user injury. It is important to understand that the safety information is not exhaustive. It is meant to keep the user safe while using the system. WHEN NOT TO USE (CONTRAINDICATIONS) :

No MRI/CT/Diathermy: The RIGHTEST CGMs (sensor, transmitter, Receiver and/or other receiving devices) must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or high frequency electrical heat (diathermy) treatment. If you are in the serious incidents caused by the RIGHTEST product, please call local emergency service for help. Please feel free to report your incident to us and the local competent authority. 6 7 Safety Information Safety Information WARNINGS :

Read This Manual First. Failure to operate the system according to the guidelines and safeguards specified in this manual could result in a hazardous condition. DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter; or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend arrow. If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver display, you must check your BG value with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. Not Getting Urgent Alarm/Alert. The RIGHTEST CGMs Receiver lets you know when your sensor readings drop to or below 54 mg/dL; or when your sensor reading is below 70 mg/dL and continuously falling for the following reading(s) regardless your alarm/alert settings. There are no alarm/alerts in the following situations. When either your receiver or transmitter battery is dead. When your receiver is turned off. When there is a system error (e.g. no glucose readings, sensor error, signal loss etc.) or system damage. During the 2-hour sensor warm-up period. If your sensor readings do not match what you are feeling. When the receiver is out of range (6 meter/20 feet) from your transmitter; or obstacles (metal, wall or water etc.) are between them. Modification of the System is Not Allowed: Do not modify or tamper with any components or accessories of the RIGHTEST CGMs. Otherwise, you could damage the integrity of the system and put yourself at risk especially when you have a severe low or high glucose event. Children or pets without adult supervision: Dont put any parts of the RIGHTEST CGMs in your mouth or let children and pet play with it without adult supervision. Choking Hazard: The RIGHTEST CGMs contains small components that may be dangerous if swallowed. INTERNALLY POWERED ME EQUIPMENT. Not Suitable for use in an OXYGEN RICH ENVIRONMENT 8 9 Safety Information Safety Information PRECAUTIONS :

DO NOT Use If You Are Pregnant, on Dialysis or Critically Ill. Do not use the RIGHTEST CGMs if you are pregnant, on dialysis or critically ill; or on users with other implanted medical devices (e.g. a pacemaker). The system has not been evaluated in these populations. DO NOT Use the System on Skin With Extensive Skin Changes or Diseases. Do not use the RIGHTEST CGMs on persons who have extensive psoriasis, extensive eczema, extensive scarring, or extensive tattoos; or on skin insertion sites that are dermatitis herpetiformis infected, irritated, burned or cut. Calibration Safety: Calibration is not required if users scan sensor & transmitter codes. If necessary, calibrate your system for accurate readings. Take additional precautions when you enter your blood glucose value. Entering incorrect blood glucose values for calibration can result in inaccurate glucose readings, which may result in you missing a high or low glucose event. Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion. This helps the sensor stay attached to your body. Skin Irritation Reaction Caused by Sensor Adhesive: Some individuals may be sensitive to the medical adhesive that keeps the sensor attached to the skin. If you develop a rash around or under your sensor, remove the sensor and stop using the RIGHTEST CGMs. If needed, consult your health care professional. Avoid Skin Care Products or Insect Repellent: Do not apply skin care products such as sunscreens, moisturizer or perfume over the sensor insertion sites. Insect repellent may damage the plastic used in the RIGHTEST CGMs. Failure to comply may lead to inaccurate system performance. Store the Sensor in a Dry Room: Store your sensor at a temperature of 5C to 30C

(41F to 86F) and 10% - 90% non-condensing humidity. You can also store the sensor in the refrigerator at 5C to 30C (41F to 86F). Do NOT freeze the sensor. DO NOT Reuse Your Inserter, and Sensor: The inserter is pre-loaded with a sensor. The entire sensor inserter package is sterilized and designed for single use. All RIGHTEST CGMs components are not suitable for re-sterilization. Reuse of these components may result in no glucose readings and infections. Discard Sensor Inserter in an appropriate puncture-proof or biohazard container, for safety and to prevent cross-contamination. Check sensor package. Do not use the sensor if its sterile package has been damaged or open because it may cause infection. Use the Charger as Directed: Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Use USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation risk. 10 11 Safety Information Safety Information Going Through Security Check Points. Remove all parts of the RIGHTEST CGMs before exposing it to an X-ray machine. The effect of X-rays on the system has not been evaluated. Adequate Brightness while reading: If you have difficulty reading your receiver in bright sunlight, you may need to seek a shady location. Do NOT Use If the Receiver is Damaged, or If It Could Fall into Water. The receiver and accessories are enclosed without protection from the ingress of water. Do not submerge these components in water. If the receiver has fallen into water, do not touch it until you unplug it from any electrical outlet. Touching the receiver while it is wet or damaged could result in electric shock or no glucose results. Test Your Receiver Regularly. Test your receivers speaker and vibration functions regularly. If you are in any doubt, contact a manufacturer authorized dealer for technical support. Keep Your Receiver Close. Be sure your receiver is close to your transmitter and in the same room. The maximum transmission distance is 6 meters (20 feet) with no obstructions (e.g. wall, metal, glass or water) in between. Obstructions or longer distances may cause Bluetooth signal loss and you will not receive important alerts/alarms. Plug in to Charge. Be sure to fully charge your transmitter every time you start with a new sensor. When plugged into an adapter that is connected to a standard household electrical outlet (100 to 240V AC, 50/60Hz), the transmitter battery requires approximately 2 hours to fully charge. When connected to your personal computers USB port or USB car charger adapter, it may take a longer time. To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in your receiver to its charger at the end of the day and charge it up overnight. 12 13 Symbol Definitions III. SYMBOL DEFINITIONS The following symbols apply to the RIGHTEST CGMs SYMBOL DEFINITION SYMBOL DEFINITION Date of Manufacture Do not use if package is damaged Manufacturer Biological risks Authorized representative in the European Community For single use only Batch/Lot Number Type BF applied part device Expiry date Direct current Temperature limitation Alternating current Humidity limitation MD Medical Device Method of sterilization using irradiation Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. 14 SYMBOL DEFINITION SYMBOL DEFINITION Protected against insertion of fingers and dripping water. Protected from touch by fingers and objects greater than 12.5 millimeters. Protected from condensation. Serial Number CE Mark with Notified Body Number Bluetooth Input Importer Keep away from heat Class II Equipment Warning/Precaution Symbol Definitions Keep Dry MR Unsafe Prescription Required Refer to Instruction Manual/

Booklet Electrical Equipment Designed Primarily for Indoor Use (Chargers Only) Operating Instructions; consult manual for further instructions Near-field communication (NFC) scan area 15 Getting to Know Your RIGHTEST CGMs Getting to Know Your RIGHTEST CGMs IV. GETTING TO KNOW YOUR RIGHTEST CGMS WHAT IS INCLUDED 1. SENSOR INSERTER : Designed with a pre-loaded sensor. 2. TRANSMITTER : Rechargeable for multiple-use for a single patient. 3. RECEIVER : Blood glucose information display. 4. POWER SUPPLY: AC power adapter & USB cable. 5. TRANSMITTER CHARGER : A USB charging dock for the transmitter. 6. STORAGE VIAL: Storage for the transmitter and transmitter USB charger to keep them dry. 16 17 Getting to Know Your RIGHTEST CGMs Getting to Know Your RIGHTEST CGMs PERFORMANCE FEATURES The RIGHTEST CGMs is an integrated continuous glucose monitoring system (iCGM) that provides glucose readings, trends, and levels every minute. The system is comprised of three main components: (a) a Sensor, (b) a Bluetooth Transmitter and (c) a Receiver. The sensor is pre-loaded inside an Inserter. The sensor is inserted under your skin and measures your interstitial glucose level test glucose. The transmitter wirelessly sends data to the receiver. The receiver displays glucose values and alerts users to hypoglycemia and hyperglycemia. The RIGHTEST CGMs user-friendly features and benefits include:

Ergonomic design of sensor inserter allows users to insert the sensor safely with just one hand. Easy-to-read visual glucose values and trends. Transmitters powerful storage holds 14 days of glucose readings with zero data loss. Getting visual and audible alerts to hypoglycemia and hyperglycemia. Lightweight sensor and transmitter for maximum comfort. SAFETY FEATURES The RIGHTEST CGMs offers a number of important safety features when you use it. These features include:

Receivers alarm/alert includes visual notification, vibrations and sound, depending on your personalized settings. When you are out of your target glucose range, the receiver alerts you. Receiver warns you if your glucose level falls below 54 mg/dL; or when your sensor reading is below 70 mg/dL and continuously falling for the following reading(s). Urgent alert/alarm settings at 54 mg/dL or below; or below 70 mg/dL and continuously falling for the following reading(s) cannot be changed or turned off. Receiver notifies you when a sensor has failed, expired or when there are system errors. 18 19 Getting to Know Your RIGHTEST CGMs Getting to Know Your RIGHTEST CGMs THE RIGHTEST CGMS COMPONENTS The RIGHTEST CGMs consists of 3 key parts: a Sensor, a Transmitter and a Receiver. These 3 parts are described below:

ACCESSORIES Inserter Sensor Inside SENSOR INSERTER The inserter is pre-loaded with a sensor and does not require user assembly. The inserter helps you place the sensor wire under your skin with ease. The sensor measures your glucose information. TRANSMITTER The transmitter sends your glucose data from the sensor to the Receiver. The transmitter is equipped with a rechargeable battery. RECEIVER The receiver displays glucose values and alerts you to hypo/

hyperglycemia. TRANSMITTER CHARGER A USB charger is included with your transmitter. STORAGE VIAL The vial is used for storage of a spare transmitter and its USB charger to keep them dry. POWER SUPPLY (USB CABLE AND AC POWER ADAPTER) AC power supply & USB cable for the Receiver. It connects to an AC mains outlet (100 to 240V AC, 50/60 Hz). 20 21 Before Getting Started Before Getting Started V. BEFORE GETTING STARTED CHARGING THE RECEIVER CHARGING BASICS Before using the system for the first time, charge the receiver for a complete charging cycle without interruption. A transmitter charger is supplied along with your transmitter package. Rechargeable transmitters must be fully charged each time you start a new monitoring session. Otherwise, your sensor will likely not remain operational until the end date of sensor wear period (14 days). A complete charging cycle of the receiver takes about 4 hours. For the transmitter it takes about 2 hours when using the supplied USB adapter plugged into a standard household electrical outlet

(100 to 240V AC, 50/60 Hz). It is recommended to use only the supplied USB cable and USB power adapter. WARNINGS :

Not Getting Urgent Alarm/Alert. There are no alarm/alerts, when your receiver is turned off or its battery is dead. PRECAUTIONS :

Use Charger as Directed. Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Plug in to Charge. To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in your receiver to its charger at the end of the day and charge it up overnight. 22 23 Before Getting Started Before Getting Started 1. Connect the micro-USB plug of the charging cable to the USB Type C input of the receiver. 2. Connect the USB plug to the USB port of the AC power adapter supplied with your system, and connect the adapter to the power source. Alternatively, connect plug to the USB port of your computer or USB car charger adapter. 2

* Accessories not included. 1 24 25 Before Getting Started Before Getting Started BATTERY LIFE INDICATOR ON THE RECEIVER From the receiver display, battery level (as a percentage of full charge) and the battery status icon

(charging or discharging) is displayed in the top-right corner of the screen. When the receiver is charging, you will see lightning bolt in the middle of the battery icon. The receiver utilizes an intelligent battery charging technology that prevents overcharging. CHARGING TRANSMITTER WARNINGS :

Not Getting Urgent Alarm/Alert. There are no alarm/alerts when your transmitter battery is dead. PRECAUTIONS Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and transmitter. Using different chargers or AC power adapter could damage the system or cause fire. Plug in to Charge. Be sure to fully charge your transmitter every time you start with a new sensor. When plugged into a standard household electrical outlet (100 to 240V AC, 50/60 Hz), the transmitter battery requires approximately 2 hours to fully charge using the transmitter charger supplied with the RIGHTEST CGMs. When connected to your personal computers USB port or USB car charger adapter, it may take a longer time. 26 27 Before Getting Started Before Getting Started It is important to charge the transmitter battery to its full charge every time before you begin with a new sensor to ensure data is collected from the sensor and sent to receiver during entire wear period (14 days). Storage Vial 1. Take out your transmitter charger from its storage vial. Hold the charger face up. 1 2 Transmitter Charger 2. Make sure the alignment notch of the transmitter is facing the chargers transmitter compartment with the transmitter mark facing up. With the transmitter outer frame between your fingers, steadily slide the transmitter all the way into the compartment. Alignment Notch 3 4

* Accessories not included. Lock Button

(in lock position) 3. With the transmitter secured inside its charger compartment, turn over the charger to the back side and slide the lock button outwards. 4. Plug the chargers USB plug into the USB port on the AC power adapter supplied with the RIGHTEST CGMs, then plug the AC power adapter inot the AC mains outlet (100 to 240V AC, 50/60 Hz). You can also charge your transmitter with a computer or a car charger adapter with a USB port but it may take much longer. 28 29 Before Getting Started 5. When you connect the transmitter charger to a USB power source, the LED on the charger lights up. The charge condition of transmitter battery is indicated below: a solid green ( ) light means the battery is fully charged. 5 Fully charged Charging a solid amber ( ) light means the battery is charging. NOTE :

If the LED doesnt light up, make sure you connect to a power source with output rating of 500 mA or higher. If this does not solve the issue, check with another power source again then contact customer support. 6. After the transmitter is fully charged, unplug the transmitter charger from the power source. 7. If you wish to take out the transmitter from its charger, or to store the transmitter charger, turn over the charger to the back side and press the lock button slightly downward, then slide the lock button all the way inward. 7 30 31 Set Up Your RIGHTEST CGMs VI. SET UP YOUR RIGHTEST CGMS Before setting up your RIGHTEST CGMs, make sure you have everything you need:

Sensor Inserter Package Alcohol Wipes Transmitter Receiver Your Blood Glucose (BG) Meter Set Up Your RIGHTEST CGMs 1. Get your receiver. 2. If your receiver is OFF, press and hold the [Power] button for 2 seconds to turn ON. If your receiver is ON, press the [Power] button briefly to wake up its display. NOTE :

If using the receiver for the first time, follow prompts to set the date, time and your glucose target & alerts. PAIRING THE SENSOR AND TRANSMITTER USING NFC 2 PRECAUTIONS :

Scan the NFC Tags First before Connecting to the System: Each sensor has its unique code established on the tag attached on the sensor inserter package. The transmitters code is located right beneath its top plastic cover where you see a mark. Every time you begin the use of a new sensor, scan both codes to ensure successful system connections. The system will not start if you fail to scan the codes. The following steps describe using receiver to make a sensor-transmitter pair. If the instructions provided do not work, the receiver will display an error message. 32 Power Button 33 Set Up Your RIGHTEST CGMs 3. Tap [Home] at the bottom of your receiver screen. Then, tap [New Monitor] to start a new monitoring session. 3 Set Up Your RIGHTEST CGMs 4. When the receiver prompts you to pair the sensor &

4 transmitter, choose [Pair]. 34 35 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 5. Locate the NFC panel at the top of your receivers back cover. The center of NFC panel is engraved with a mark. 5 6. Tap the receivers NFC panel against the tag on top of the sensor inserter package until you hear a beep sound. 6 NFC panel NOTE :

Be sure your receivers NFC panel is within 1 cm

(3/8) of the NFC tag/mark when you scan the codes. NFC Tag 36 37 Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed 7 as by checkmark ( ) on the receiver screen. Set Up Your RIGHTEST CGMs 8. Tap receivers NFC panel against the NFC mark 8 on the top of transmitter until you hear a beep sound. NOTE :

Be sure your receivers NFC panel is within 1 cm

(3/8) of the NFC tag/mark when you scan the codes. 38 NFC mark 39 Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as 9 by checkmark ( ) the screen. Set Up Your RIGHTEST CGMs 10. When the receiver displays Pairing Complete, press [Next]. 11. You will be prompted to enter your personal security code. Then press [Done]. 12. Make sure you follow the step-by-step instructions in the installation guide described in the next 2 sections (Apply Your Sensor and Attach Your Transmitter). After the sensor and transmitter are installed, press [Start Sensor]. 10 11 12 40 41 Set Up Your RIGHTEST CGMs APPLY YOUR SENSOR PRECAUTIONS :

Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion. This helps the sensor stay attached to your body. DO NOT Place the Sensor on Any Area of the Body other than the Upper Arm: Placing the sensor on other areas of the body has not been tested and the risks are unknown. Select an Appropriate Sensor Insertion Site: Do NOT place the sensor on skin that is painful to touch, raised (higher than surrounding skin), crusting or bleeding; or on areas with scars, tattoos or moles. Select a skin area that stays flat during normal daily activities. Choose a site that is greater than 1 inch (2.5 cm) away from any insulin injection sites. Change the Sensor Insertion Site for the Next Sensor Insertion: Placing the next sensor on the same spot will increase skin irritation or redness and could potentially lead to scabs. Excessive Sweat or Body Movement Can Cause Your Sensor to Loosen: Remove and replace your sensor if it starts to loosen. 42 Set Up Your RIGHTEST CGMs The sensor is pre-loaded inside the inserter. Before applying the sensor to your skin, get familiar with the information in this section. Overview of Sensor Inserter Sensor Base:

Holds your transmitter in place Sensor Inserter Sensor:

Inserts into your skin Adhesive Patch:

Keeps sensor and sensor base on the skin 43 Set Up Your RIGHTEST CGMs Follow these steps to apply your Senso 1. Choose an insertion site on the upper arm. NOTE :

Use a different site for the next sensor insertion. Set Up Your RIGHTEST CGMs 5. Gently move the inserter away from your insertion site. 6. Make sure the sensor is securely attached to your skin. 7. Discard the inserter and its package according to local regulations. 2. Wipe the insertion site with an alcohol wipe and wait approximately for 2 minutes until the site 6 dried out thoroughly before getting started. 3. Take out the sensor inserter from its package. Open the sensor inserter cap. 4. Place the inserter over the site and push down firmly to insert the sensor. Stay for 10 seconds to ensure the adhesive patch is fully attached to your skin. NOTE :

Do not apply the inserter if the base falls out when opening the cap. Use a new one. Do not apply the inserter if it is misused before the insertion. Use a new one. Apply the inserter immediately after opening its package and cap. Do not push down the inserter until it is placed over the insertion site. 3 4 2 44 45 Set Up Your RIGHTEST CGMs ATTACH YOUR TRANSMITTER PRECAUTIONS :

DO NOT Use If Any Components Appears to be Damaged or Past Its Expiration Date. A damaged or cracked inserter, sensor, transmitter, or receiver could compromise the integrity of the system or contribute to infection risk. Do not use if your sensor has past its expiration date. The sensor expiration date is in YYYY-MM-DD (Year-Month-Day) format on your Inserter Package. DO NOT Share Your Re-chargeable Transmitter. The RIGHTEST CGMs transmitter is rechargeable and reusable. Never share your transmitter with others. The system is a prescription-only medical device and is meant for your use only. If used by other persons, the glucose readings, report, alarms/alerts, etc., may be wrong. Use Charger as Directed. Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Set Up Your RIGHTEST CGMs Plug in to Charge. Be sure to fully charge your transmitter every time you start with a new sensor. When plugged into a standard household electrical outlet (100 to 240V AC, 50/60 Hz), the transmitter battery requires approximately 2 hours to fully charge using the transmitter charger supplied with the RIGHTEST CGMs. When connected to your personal computers USB port or USB car charger adapter, it may take much longer. Overview of the Transmitter Transmitter:

Rechargeable for multiple-use Alignment notch on the transmitter Alignment notch on the sensor base 46 47 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs Attach your transmitter after you insert a sensor. Dock your spare transmitter in the transmitter charger. Store both the transmitter and its charger in the storage vial provided with your RIGHTEST CGMs. Before attaching the transmitter, make sure it is fully charged. Do not remove your transmitter until your sensor session is over. 3. Let the transmitter dry. 4. Align both notches on the sensor base and transmitter. 5. Press down the transmitter until it snaps into place. 4 5 Follow these steps to install your Transmitter:

1. Get your transmitter. NOTE :

Be sure your transmitter is fully charged every time you start with a new sensor. 2. If necessary, clean the transmitter with an alcohol wipe. While you do so, do not touch or scratch its metal components located at the bottom. 2 NOTE :

Wipe the bottom of transmitter with a dry cloth or an alcohol pad. Failure to clean it may cause it to deteriorate and harden over time, resulting in malfunction. 48 49 Set Up Your RIGHTEST CGMs CONNECT TRANSMITTER WITH RECEIVER WARNING :

Use a Blood Glucose (BG) Meter. During the first 2-hour sensor warm-up period after you insert a new sensor, use a BG meter to make treatment decisions. You wont get any sensor readings, alarms or alerts until your system begins to transmit data. PRECAUTIONS :

Test Your Receiver Regularly. Test your receivers speaker and vibration functions regularly. If you are in any doubt, contact a manufacturer authorized dealer for technical support. Keep Your Receiver Close. Be sure your receiver is close to your transmitter and in the same room. The maximum transmission distance is 6 meters (20 feet) with no obstructions

(e.g. wall, metal, glass or water) in between. Obstructions or longer distance may cause Bluetooth signal loss and you will not receive important alerts/alarms. Set Up Your RIGHTEST CGMs NOTE :

Make sure you go through all steps in the Pairing the Sensor and Transmitter using NFC section. Make sure that you have your sensor and transmitter installed properly before you start the following steps. 1 1. Make sure you have followed the installation guide described in the Apply your Sensor" and "Attach Your Transmitter sections. Then, when the receiver displays Your system is about to start, press [Connect]. 50 51 Set Up Your RIGHTEST CGMs 2 NOTE :

If your receiver doesnt start the search or displays a Cannot Connect to Sensor/Transmitter Pair message, go through the steps in the Pairing the Sensor and Transmitter using NFC section again. If the problem persists, refer to the troubleshooting section. 2. The receiver will automatically start searching for your sensor-transmitter pair. Keep your receiver close to you. Set Up Your RIGHTEST CGMs 3. After the system is connected, the Receiver displays the warmup progress and remaining warmup time. When the warmup is completed, "Warmup" disappears from your display. 3 52 53 Ending a Monitoring Session VII. ENDING A MONITORING SESSION You will receive a 24 Hours Before the End of Sensor Session alert on your receiver 24 hours prior to monitoring ending. Press [OK] to confirm you have read this alert . Ending a Monitoring Session 54 55 Ending a Monitoring Session Ending a Monitoring Session END THE MONITORING SESSION Before you remove the sensor. Either:

Wait for the sensor to fully expire. You will receive a Sensor Expired alert and the session will end End the monitoring session early by selecting the upper right in My menu. You will see a message warning you that the sensor has not expired yet. Press [Stop anyway] to end the session. automatically. Press [Done] confirm you read this alert. 56 57 Ending a Monitoring Session Ending a Monitoring Session SENSOR AND TRANSMITTER REMOVAL Once the session has ended, follow these steps to remove your sensor and transmitter:

1. Grip the edge of the patch attached to your skin. Slowly pull upwards to peel it off. 2. Pick up the sensor base and transmitter. Note that one edge of the base has a notch. 3. Locate a point two-thirds along the length of the base and across from the notch. Then pinch firmly at this point with your thumb and index fingers. While you do so, grip a corner of the notched edge of the sensor base with your other hand. 4. Press down firmly with both your hands to bend the base away from the transmitter. 5. The transmitter will pop out as you bend the base. You will hear a click as the transmitter detaches. 6. Discard the sensor according to local regulations. NOTE :

Do not throw away the Transmitter. Transmitters are reusable after recharging. 1 3 4 58 59 Understand Your Glucose Readings VIII. UNDERSTAND YOUR GLUCOSE READINGS Your sensor glucose readings appear on your receiver displays Home screen. It is important to understand your readings. HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW Your glucose information (e.g. reading, glucose graph, trend arrow indicating rates and direction of glucose change. etc.) is displayed on your receivers Home screen. It is important to understand these indicators before use. An overview of the home screen is shown below. Understand Your Glucose Readings Overview of Receiver Home Screen Sounds & Vibration System connection status Glucose High/Low Alerts Check Blood Glucose When you see this symbol, you must check your blood glucose value with a meter before making any treatment decisions. Add Notes Current Time Receiver battery level Days until sensor expiration Trend Arrow Glucose Reading Transmitter battery level Most recent data point Target Glucose Range 60 61 Understand Your Glucose Readings Understand Your Glucose Readings GLUCOSE INFORMATION Your most recent glucose reading is displayed inside a circle with an arrow on top of the receiver screen. The arrow shows the direction of your glucose trend. A symbol reminds you to do a fingerstick blood glucose test before making treatment decisions. You will see this symbol in each of the following situations:

Your glucose is less than 70 mg/dL regardless of your detected trend direction. Your glucose is rising or falling rapidly at or more than 2 mg/dL per minute. There is no glucose value or trend arrow (HIGH/LOW event). During the first 2 hour sensor warmup period. The sensor glucose concentration reading range is 40 - 500 mg/dL. A glucose alert safety symbol

( or ) will appear in the following situations:

When your glucose is at or higher than 250 mg/dL, and is detected to rise or remain steady. When your glucose is at or less than 70 mg/dL, and is detected to fall or remain steady. Fingerstick Check and Alerts/Message Glucose High/Low Alerts Glucose message Check Blood Glucose When you see this symbol, you must check your blood glucose value with a meter before making any treatment decisions. 62 63 Understand Your Glucose Readings Understand Your Glucose Readings GLUCOSE TREND ARROW AND ARROW COLOR There are 5 different trend arrows reflecting your glucose readings and how fast they are changing. The color (orange, amber, green, rouge and red) of the arrow helps identify the risk of hypoglycaemia and hyperglycaemia. Direction What it means Glucose is steady*

Glucose rising**

Glucose rising rapidly***

Glucose falling**

Glucose falling rapidly***

Arrow Color ORANGE:

>250 mg/dL AMBER 181 - 250 mg/dL GREEN:

70 - 180 mg/dL ROUGE:

54 - 69 mg/dL RED:

<54 mg/dL 64 65

*glucose is steady means the glucose rate of change is in between 0 to 1 mg/dL.

**glucose falling/rising means the glucose rate of change is in 1 - 2 mg/dL per minute.

***glucose falling/rising rapidly means the glucose rate of change is at or more than 2 mg/dL per minute. Understand Your Glucose Readings Understand Your Glucose Readings TREND GRAPH The trend graph is displayed on the lower portion of the screen. It shows your glucose trend for the past 6 hours. The graph adds one reading every 5 minutes. The most recent data point is marked by an open-target double circle at the right end of the plot. The sensor glucose reading range is 40 - 500 mg/dL. The trend graph uses a dynamic range of 0 - 500 mg/dL. The default graph displays a range of 0 - 250 mg/dL and is able to reproduce the maximum range as required when taking actual readings. Overview of Trend Graph Default Graph Range: 0 - 250 mg/dL Reproduced Graph Range: 0 - 500 mg/dL Most Recent Reading Note logs Add Notes High Target Low Target Note logs 66 67 Understand Your Glucose Readings ADD NOTES 1. From the Home screen, add a note by tapping 1 the symbol in the lower right corner of the screen. Understand Your Glucose Readings 2. Make sure the time is correct. 3. Select the options (carbs, insulin, exercise) then follow the prompts. 4. Tap to save your notes. Notes are viewable in your logbooks. 2 3 4 68 69 Understand Your Glucose Readings Understand Your Glucose Readings ACCESS YOUR NOTES INFORMATION Personal notes (insulin, meals, exercise) are marked by blue triangle on the bottom of the graph. If you performed calibration, the calibration record (if accepted) is marked with a blue target symbol and is viewable in the note. To access your sensor glucose information or to view your personal notes from anytime between the first and most recent reading, hold and drag the trend graph left or right. Note entries will be displayed on the upper portion of the receiver screen. Tap the [Back]

button to return to he Home screen showing the most recent glucose information. Note Date/Time Events Calibration History at selected point in time Glucose reading at selected point in time Hold and drag left or right on the graph Calibration Symbol 70 71 Understand Your Glucose Readings Understand Your Glucose Readings HIGH/LOW READING If HIGH appears on your receiver screen, your glucose reading is above 500 mg/dL. Do a fingerstick blood glucose test with a BG meter. If you also get a HIGH result (> 500 mg/dL) from the meter test, contact your healthcare practitioner immediately. If LOW appears on your receiver screen, your glucose reading is less than 40 mg/dL. Do a fingerstick blood glucose test with a BG meter. If you also get a LOW result (< 40 mg/dL) from the meter test, contact your healthcare practitioner immediately. HIGH/LOW Reading 72 73 Review Your Glucose History IX. REVIEW YOUR GLUCOSE HISTORY Your receiver will record and analyze up to 90 days of glucose data using Ambulatory Glucose Profile

(AGP) techniques. Make sure you have data for at least 7 - 10 days (ideally more than 14 days) to identify your glucose patterns. The 7 days, 14 days, 30 days and 90 days result of AGP analysis can be reviewed on the Report page. From the Report screen, choose the duration of your glucose summary statistics to review on the upper portion. By pooling data from multiple days, graphs showing the 24-hour glucose level percentage and daily glucose level are shown below. Glucose History Review Your Glucose History Choose a report duration from here!

74 75 Calibration (Optional) X. CALIBRATION (OPTIONAL) Your RIGHTEST CGMs features factory-calibration that calculated correction factors based on factory input reference values. The system does not need user calibration and you will not receive any calibration prompts from your receiver. Calibrating your RIGHTEST CGMs is optional. The calibration allows alignment between your system readings and your meter values. WARNINGS :

DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. arrow. 76 1 If you are experiencing rapid glucose changes

(more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver display, you must check your BG value with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. CALIBRATE When you calibrate, take a fingerstick measurement from your BG meter then enter the value according to the following steps:

1. From the Calibrate screen, tap [Calibrate Now]. Calibration (Optional) 77 Calibration (Optional) 2. Enter the exact BG value then press [Next]. If incorrect, tap the backspace key on the numeric keypad to erase the entries then enter the correct value. 2 NOTE :

Make sure you enter the exact value that is measured with 5 minutes. Calibration (Optional) 3. You will see a prompt from receiver. Tap [Yes] or [No]. 4. The messages on the right side of the Calibrate screen display the calibration progress and whether your entry is accepted or not. 4 3 78 79 Treatment Decisions XI. TREATMENT DECISIONS Before you start using the RIGHTEST CGMs for treatment decisions, make sure you are familiar with the tips provided in this chapter and you have a good understanding of how the system works. Continue to use your blood glucose meter for treatment decisions until you are comfortable with Getting familiar with the system could take days, weeks, or even months. Work with your healthcare practitioner and follow his/her recommendation to put together a plan Trace your note logs often to see how carbs, medication, exercise, illness, or stress levels impact the information you receive. for making treatment decisions. your sensor glucose reading. Treatment Decisions WARNINGS :

DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter; or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend arrow. If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver display, you must check your sensor reading with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. 80 81 Treatment Decisions Treatment Decisions WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS You must NOT make treatment decisions based on your sensor glucose reading in the following situations:

When to NOT Make a Treatment Decision Whenever you see this symbol on your screen, When to NOT Make a Treatment Decision When you suspect that your sensor blood glucose readings may be inaccurate for any reason. When your sensor blood glucose readings do not match what you are feeling. When you are experiencing symptoms that may be due to low or high blood glucose. When the Receiver displays no glucose information (e.g. an interrupt alert). Glucose is Falling/Rising Rapidly (with upwards/ downward pointing arrow): Glucose measured in interstitial fluid may differ substantially from blood glucose levels, particularly at times of rapid glucose change (e.g. after meals, taking insulin, or exercising). Low Glucose or Urgent Low Message: Sensor glucose readings may not accurately reflect your blood glucose. No Glucose Trend Arrow: During the first 2-hour warmup period when you start a new sensor, the system cannot tell you if your glucose is rising quickly or falling quickly. No Current Glucose Concentration and Trend Arrow: When there is a HIGH/LOW result, you dont have enough information to make a treatment decision. do a fingerstick blood glucose test and make treatment decisions based on that result. 82 83 Treatment Decisions Treatment Decisions TREND ARROWS AND TREATMENT DECISIONS Trend arrows show the direction and rate of change of your glucose to give you an idea of where your glucose is going. The following table gives you some ideas on how you may use the arrows when considering your treatment. NEVER make a treatment decision based on the RIGHTEST CGMs alone. Treatment Decision Trend Arrow

(No Trend Arrow) 90 upward arrow Low Glucose

(< 70 mg/dL) Glucose in Target Range High Glucose

(> 250 mg/dL) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs.

(All Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. Trend Arrow 45 upward arrow Low Glucose

(< 70 mg/dL)

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. Treatment Decision Glucose in Target Range High Glucose

(> 250 mg/dL) If you are about to eat, take insulin to cover your meal. Consider increasing your dose a little since your glucose is rising.

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider increasing your dose a little since your glucose is high and rising. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. Avoid Insulin stacking. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. If you have not recently taken insulin and have finished exercise, consider adjusting your insulin correction dose upwards. Avoid Insulin stacking. 84 85 Treatment Decisions Treatment Decisions Trend Arrow Low Glucose

(< 70 mg/dL) Glucose in Target Range High Glucose

(> 250 mg/dL) Trend Arrow Horizontal arrow

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. If you are about to eat, take insulin to cover your meal. If youve recently taken insulin or are about to exercise, do nothing and check your sensor reading later. Avoid Insulin stacking.

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider increase your dose a little since your glucose is high. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. If you have not recently taken insulin and have finished exercise, consider adjusting insulin correction dose upwards. Avoid Insulin stacking. Trend Arrow 45 downward arrow Low Glucose

(< 70 mg/dL)

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. Trend Arrow Glucose in Target Range If you are about to eat, take insulin to cover your meal. Consider taking a lower dose since your glucose is falling. If youve recently taken insulin or have finished exercise, eat some snacks or fast-

acting carbs. High Glucose

(> 250 mg/dL)

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider taking a lower dose since your glucose is falling. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. Avoid Insulin stacking. 90 downward arrow

(All Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. 86 87 Specifications Inserter Size Sterilization Usage 52.0 x 57.0 x 61.3 mm ( 0.5 mm) Sterilized by radiation Single use (disposable) Specifications XII. RIGHTEST CGMS SPECIFICATIONS SENSOR INSERTER SPECIFICATIONS Sensor Glucose Range 40 - 500 mg/dL Sensor Useful Life up to 14 days Sensor Inserter Shelf Life 12 months Sensor Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Sensor Ingress Protection Rating

(when installed with a transmitter) IP47 Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. Inserter Storage & Transportation Conditions Temperature: 5C - 30C (41F - 86F) Relative humidity: 10% - 90% (in a cool, dry place) Operating and Storage Altitude 0 to 3,048 metres (0 to 10,000 ft) 88 89 Power Source Rechargeable lithium battery (3.7V/25mAh) Data Communication Specifications TRANSMITTER SPECIFICATIONS Transmitter Size 32.8 x 19.8 x 4.15 mm ( 0.5 mm) Transmitter Weight 3.2 g with battery ( 0.5 g) Storage Transportation &

Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Operating and Storage Altitude 0 to 3,048 metres (0 to 10,000 ft) Battery Run Time Up to 14 days (based on full charge) Power Charging Time 2 hours (via AC adapter) Memory Storage 14 days of glucose data (glucose readings stored every minute) Protection Against Electrical Shock Type BF applied part 90 Ingress Protection Rating

(when attached to Sensor) Specifications IP 47 Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. Bluetooth 4.0 Frequency range BLE : 2402 ~ 2480MHz Maximum RF output power of the product : 0 dBm System pairing: NFC pairing (RFID: 13.56 MHz) Data Communication Range Up to 6 meters (20 feet) Quality of Service The Transmitter and Receiver connect to each other via BLE network. Quality of the connection is in accordance with the Bluetooth Specification v4.0. The RIGHTEST CGM System is designed to accept radio frequency (RF) communications from recognized and paired display devices only. 91 Specifications RECEIVER SPECIFICATIONS Dimension Weight Power Source Memory Storage Touch Screen Size 4 inches 126.1 x 68.1 x 15.2 mm with battery and silicone case

(1.0 mm) Data Communication 145 g with battery and silicone case ( 8%) Charging Port USB type C Rechargeable lithium battery (3.7V/1150mAh) Ingress Protection Rating Up to 90 days (typical use) Battery Longevity 1 days (typical use) Power Supply Battery Charging Time 4.5 hours (via AC adapter) Storage Transportation & Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Alarm Output Sound Speaker; Vibration Only update authorized by Bionime Corporation is recommended. Any update from unofficial channel may bring security risk. 92 93 Specifications Glucose data transfer: Bluetooth 4.0 Frequency range BLE : 2402 ~ 2480MHz Maximum RF output power of the product : 2 dBm System pairing: NFC pairing (RFID: 13.56 MHz) IP22 Protection against insertion of fingers and objects greater than 12.5 millimeters. Protection against dripping water when tilted up to 15. Input: 100 - 240V AC, 50 - 60 Hz, 0.2A Output: DC5.0V, 1.0A, 5.0W Operating temperature: 0C ~ 45C Specifications TRANSMITTER CHARGER SPECIFICATIONS Charger Channel 1 Charger Dimensions 37.3 x 26.0 x 22.5 mm ( 0.5 mm) LED (Green/ Amber) USB Type A 10 g ( 1.0) DC 5V/18 ~ 20 mA DC 4.2V/18 ~ 20 mA Indicator Input Port Weight Input Output Storage Conditions Operation Conditions 94 Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Caution: When operating the transmitter on a tester in air temperatures greater than 41C (106F), the temperature of the transmitter may exceed 43C (109F) Ingress Protection Rating IP21 Protected from touch by fingers and objects greater than 12.5 millimeters. Protected from condensation. Specifications 95 Certificate Statement XIII. CERTIFICATE STATEMENT RF STATEMENT This device has been evaluated to meet general RF exposure requirements. The device can be used in a portable exposure condition without restrictions. FCC STATEMENT This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference; and

(2) This device must accept any interference received, including interference that may cause undesired operation. NOTE :

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and Regulations. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause interference to radio frequency communications. There is no guarantee that interference will not occur in a particular installation. Certificate Statement Turning the equipment on and off in proximity to a radio or television will determine whether the equipment is causing interference to signal reception. If interference is present, the user is encouraged to attempt to resolve it by one or more of the following methods:

Reorient or reposition the receiving antenna. Increase the separation between the equipment and the receiving device. Connect the equipment to a different power outlet than the receiving device. Consult the dealer or an experienced radio or television technician. CAUTION :

Any changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 96 97 Certificate Statement NCC STATEMENT 98 99 Appendix XIV. APPENDIX: ALARM/ALERTS RECEIVER : GLUCOSE AND SIGNAL LOSS ALERTS Screen Event Very High Alert happens when glucose

> 250 mg/dL and is detected to rise or remain steady. Screen Event Very High Alert happens when glucose

> 250 mg/dL and is detected to rise or remain steady. Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alert: Yes.

- Vibrates 3 times and beeps 3 times at the alarm volume following the user settings. Separated by 2s.

- Sound & Vibration active unless turned off by user pressing the [OK] button on screen; or glucose is projected to fall.

- Very high glucose alert will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 100 Appendix Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alert: Yes.

- Vibrates 3 times and beeps 3 times at the alarm volume following the user settings. Separated by 2s.

- Sound & Vibration active unless turned off by user pressing the [OK] button on screen; or glucose is projected to fall.

- Very high glucose alert will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 101 Event Low Glucose Alert happens when glucose is between 55 - 70 mg/dL and is detected to fall or remain steady Screen Event Low Glucose Alert happens when glucose is between 55 - 70 mg/dL and is detected to fall or remain steady Appendix Screen 102 Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alarm : Yes.

- Vibrates 2 times and beeps 2 times at the alarm volume following the user settings. Separated by 1s.

- Sound & Vibration active unless turned off by user pressing the [OK] button; or glucose is projected to rise.

- Low glucose alert will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. Appendix Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alarm : Yes.

- Vibrates 2 times and beeps 2 times at the alarm volume following the user settings. Separated by 1s.

- Sound & Vibration active unless turned off by user pressing the [OK] button; or glucose is projected to rise.

- Low glucose alert will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 103 Event Urgent Low Alarm happens when glucose is

< 54 mg/dL. Screen Event Urgent Low Alarm happens when glucose is

< 54 mg/dL. Appendix Screen 104 Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alarm : Yes.

- Vibrates 2 times and beeps 2 times at highest alarm volume. Separated by 1/2s.

- Sound & Vibration active unless turned off by user pressing the [OK] button; or until glucose is higher than 55 mg/dL.

- Urgent low glucose alarm will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration CANNOT be turned ON/OFF by the user. Appendix Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes. Sound & Vibration Alarm : Yes.

- Vibrates 2 times and beeps 2 times at highest alarm volume. Separated by 1/2s.

- Sound & Vibration active unless turned off by user pressing the [OK] button; or until glucose is higher than 55 mg/dL.

- Urgent low glucose alarm will repeat every 30 minutes or until glucose level returns to the target range. Editable Setting:

Sound & Vibration CANNOT be turned ON/OFF by the user. 105 Appendix Screen Event Transmitter is too far from the receiver or when there is an obstacle (e.g. water, wall) in between transmitter and receiver . Screen Event Receiver battery less than 20%. Default Setting:

Visual & Sound Settings Appendix Visual message on the screen:

Yes. Sound & Vibration Alert : No. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at highest alarm volume. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed. System attempts to reconnect every 5 minutes even if user doesnt press [OK]

System alerts will repeat every 30 minutes. Editable Setting:

Sound & Vibration CANNOT be turned ON/OFF by the user. 106 107 Appendix Screen Event Receiver battery less than 10%. Default Setting:

Visual & Sound Settings Screen Event Transmitter battery less than 10%. Visual message on the screen:

Yes Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1 second.

- Displayed continuously for 5 minutes; or until [OK] pressed;

or until connected to AC mains.

- System alerts will repeat every 30 minutes. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. Appendix Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1 second.

- Displayed continuously for 5 minutes or until [OK] is pressed.

- System alerts will repeat every 30 minutes. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 108 109 Appendix Screen Event 1. Receiver scan distance is too far (> 1 cm) away from the NFC tag/mark. Yes Visual & Sound Settings Default Setting:

Visual message on the screen:

2. When the NFC tag/mark is Sound & Vibration Alert: No. damaged. Screen Appendix Event 1. Transmitter is too far from the receiver or there is an obstacle

(e.g. water, wall) in between transmitter and receiver. 2. Transmitter battery empty. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : No.

[Try again] reconnection attempted Max. 10 times. 110 111 Appendix Screen Event Transmitter is not working. Screen Event The Receiver software detects a current error measured by the sensor. Yes. Visual & Sound Settings Default Setting:

Visual message on the screen:

Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed.

- System alerts will repeat every 30 minutes. Appendix Sound & Vibration Alert: Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed.

- System alerts will repeat every 30 minutes. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 112 113 Appendix Screen Event Transmitter temperature is too high. Temporary Issue. Move to a cooler environment below 45C and wait up to 3 hours. Screen Event When sensor is to be expired in less than 24 hours. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes. Sound & Vibration Alert: No. Appendix Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes. Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed.

- System alerts will repeat every 30 minutes. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 114 115 Appendix Screen Event Your sensor session is expired. Default Setting:

Visual & Sound Settings Screen Event When the Receiver software detects a sensor that has been used. Visual message on the screen:

Yes. Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. Appendix Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes.

- Vibrates 1 time and beeps 1 time at the alarm volume following the user settings. Separated by 1s.

- Displayed continuously for 5 minutes or until [OK] is pressed. Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 116 117 Appendix XV. APPENDIX: CUSTOMER INFORMATION CUSTOMER SERVICE We sincerely like to provide complete, considerate services to our customers. Please review all the instructions to make sure you are performing the steps correctly. If you have any questions or in case of problems with the RIGHTEST CGMs, please contact your local Bionime customer service. If you are in the serious incidents caused by the RIGHTEST product, please call local emergency service for help. Please feel free to report your incident to us and the local competent authority. WARRANTY The manufacturer warrants that your RIGHTEST Receiver, rechargeable Transmitter will be free from defects in materials and workmanship for one year from the date of purchase. This warranty does not apply to the performance of a RIGHTEST product that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the RIGHTEST CGMs Products. Please complete and return the enclosed warranty card to your local Bionime affiliate. If any of the RIGHTEST CGMs Products are exposed to a high temperature difference, please wait for 30 minutes before measurement. 118

BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Tel: +886 4 2369 2388 Fax: +886 4 2261 7586 http://www.bionime.com E-mail: info@bionime.com BIONIME GmbH Tramstrasse 16 9442 Berneck Switzerland E-mail: info@bionime.ch 0197 6 0

0 2 0 2

e t a D

. v e R X X X

2 1 3 M H 3

1 0 1 N E Continuous Glucose Monitoring System User Manual Use with a receiver 1 READ THIS FIRST :

It is important to read the entire contents of this manual before using the RIGHTEST Continuous Glucose Monitoring System. The instructions, warnings, precautions, safety information as well as tips contained within this manual are intended to help ensure proper use and optimal results. It is important that you read this entire manual before using the system for the first time. 2 I. INDICATIONS FOR USE & STATEMENT AND ADVISORY INDICATIONS FOR USE STATEMENT AND ADVISORY II. SAFETY INFORMATION III. SYMBOL DEFINITIONS IV. GETTING TO KNOW YOUR RIGHTEST CGMS WHAT IS INCLUDED PERFORMANCE FEATURES SAFETY FEATURES THE RIGHTEST CGMS COMPONENTS ACCESSORIES V. BEFORE GETTING STARTED CHARGING BASICS CHARGING THE Receiver (HR310) BATTERY LIFE INDICATOR ON THE Receiver (HR310) CHARGING THE TRANSMITTER CONTENTS 6 6 6 7 16 18 18 20 21 22 23 24 24 25 28 29 3 COTENTS VI. SET UP YOUR RIGHTEST CGMS PAIRING THE SENSOR AND TRANSMITTER USING NFC APPLY YOUR SENSOR ATTACH YOUR TRANSMITTER START SENSOR WITH THE Receiver (HR310) VII. ENDING A MONITORING SESSION END THE MONITORING SESSION SENSOR AND TRANSMITTER REMOVAL VIII.UNDERSTAND YOUR GLUCOSE READINGS HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW GLUCOSE INFORMATION GLUCOSE TREND ARROW AND ARROW COLOR TREND GRAPH ADD NOTES ACCESS YOUR NOTES INFORMATION HIGH/LOW READING IX. REVIEW YOUR GLUCOSE HISTORY 4 34 34 44 48 52 62 62 64 68 68 70 72 74 76 78 80 82 CONTENTS X. CALIBRATION (OPTIONAL) CALIBRATE XI. TREATMENT DECISIONS WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS TREND ARROWS AND TREATMENT DECISIONS XII. RIGHTEST CONTINUOUS GLUCOSE MONITORING SYSTEM SPECIFICATIONS SENSOR INSERTER SPECIFICATIONS TRANSMITTER SPECIFICATIONS Receiver (HR310) SPECIFICATIONS TRANSMITTER CHARGER SPECIFICATIONS XIII.CERTIFICATE STATEMENT RF STATEMENT FCC STATEMENT NCC STATEMENT XIV.APPENDIX: ALARM/ALERTS RECEIVER (HR310): GLUCOSE AND SIGNAL LOSS ALERTS RECEIVER (HR310): SYSTEM ALERTS AND NOTIFICATIONS (WITH NO EDITABLE SETTINGS) XV.APPENDIX: CUSTOMER INFORMATION CUSTOMER SERVICE WARRANTY 84 85 88 90 92 96 96 98 100 102 104 104 104 106 108 108 108 126 126 126 5 Indications for Use & Statement and Advisory I. INDICATIONS FOR USE & STATEMENT AND ADVISORY INDICATIONS FOR USE The RIGHTEST Continuous Glucose Monitoring System (the RIGHTEST CGMs) is indicated for detecting glycaemia trends and for the management of diabetes in persons age 4 and older. For the younger user, the personal representative of a minor shall supervise their use with the RIGHTEST CGMs. It's an applied part and it is designed to replace blood glucose testing for diabetes treatment decisions. Interpretation of the RIGHTEST CGMs results shall be based on the glucose trends and several sequential readings over time. It also aids detecting episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The RIGHTEST CGMs is also intended to autonomously interface with digitally connected devices. The RIGHTEST CGMs can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes. STATEMENT AND ADVISORY This manual is designed to instruct all personnel responsible for the proper use and care of the RIGHTEST CGMs. All users are urged to carefully read this manual before using the system. 6 Safety Information II. SAFETY INFORMATION The following is a summary of safety information which must be observed before using the RIGHTEST Continuous Glucose Monitoring System (the RIGHTEST CGMs). WARNING indicates potential danger to user. PRECAUTION indicates potential injury to the user or damage to the system. To minimize risks, read the following safety information before using the system. Improper use and maintenance may damage the system resulting in failure or user injury. It is important to understand that the safety information is not exhaustive. It is meant to keep the user safe while using the system. WHEN NOT TO USE (CONTRAINDICATIONS) :

No MRI/CT/Diathermy: The RIGHTEST CGMs (sensor, transmitter, Receiver (HR310) and/

or other receiving devices) must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or high frequency electrical heat (diathermy) treatment. If you are in the serious incidents caused by the RIGHTEST product, please call local emergency service for help. Please feel free to report your incident to us and the local competent authority. 7 Safety Information WARNINGS :

Read This Manual First. Failure to operate the system according to the guidelines and safeguards specified in this manual could result in a hazardous condition. DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter; or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend arrow. If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver (HR310) display, you must check your BG value with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. 8 Safety Information Not Getting Urgent Alarm/Alert. The RIGHTEST CGMs Receiver (HR310) lets you know when your sensor readings drop to or below 54 mg/dL; or when your sensor reading is below 70 mg/dL and continuously falling for the following 2 consecutive readings (or 10 minutes) regardless your alarm/alert settings. There are no alarm/alerts in the following situations. When either your receiver (HR310) or transmitter battery is dead. When your receiver (HR310) is turned off. When there is a system error (e.g. no glucose readings, sensor error, signal loss etc.) or system damage. During the 2-hour sensor warm-up period. If your sensor readings do not match what you are feeling. When the receiver (HR310) is out of range (6 meter/20 feet) from your transmitter; or obstacles (metal, wall or water etc.) are between them them. Modification of the System is Not Allowed: Do not modify or tamper with any components or accessories of the RIGHTEST CGMs. Otherwise, you could damage the integrity of the system and put yourself at risk especially when you have a severe low or high glucose event. Children or pets without adult supervision: Dont put any parts of the RIGHTEST CGMs in your mouth or let children and pet play with it without adult supervision. Choking Hazard: The RIGHTEST CGMs contains small components that may be dangerous if swallowed. INTERNALLY POWERED ME EQUIPMENT. Not Suitable for use in an OXYGEN RICH ENVIRONMENT 9 Safety Information PRECAUTIONS :

DO NOT Use If You Are Pregnant, on Dialysis or Critically Ill. Do not use the RIGHTEST CGMs if you are pregnant, on dialysis or critically ill; or on users with other implanted medical devices (e.g. a pacemaker). The system has not been evaluated in these populations. DO NOT Use the System on Skin With Extensive Skin Changes or Diseases. Do not use the RIGHTEST CGMs on persons who have extensive psoriasis, extensive eczema, extensive scarring, or extensive tattoos; or on skin insertion sites that are dermatitis herpetiformis infected, irritated, burned or cut. DO NOT Use If Any Components Appear to be Damaged or Past its Expiration Date. A damaged or cracked sensor inserter, transmitter or receiver (HR310) could compromise the integrity of the system or contribute to infection risk. Do not use if your sensor has past its expiration date. The sensor expiration date is written in YYYY-MM-DD (Year-Month-Day) format on your sensor inserter package. Scan the NFC Tags First before Connecting to the System: Each sensor has its unique code established on the tag attached on the sensor inserter package. The transmitters code is located right beneath its top plastic cover where you see a mark. Every time you begin the use of a new sensor, scan both codes to ensure successful system connections. The system will not start if you fail to scan the codes. 10 Safety Information Calibration Safety: Calibration is not required if users scan sensor & transmitter codes. If necessary, calibrate your system for accurate readings. Take additional precautions when you enter your blood glucose value. Entering incorrect blood glucose values for calibration can result in inaccurate glucose readings, which may result in you missing a high or low glucose event. Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion. This helps the sensor stay attached to your body. DO NOT Place the Sensor on Any Area of the Body other than the Upper Arm or Abdomen: Placing the sensor on other areas of the body has not been tested and the risks are unknown. Select an Appropriate Sensor Insertion Site: Do NOT place the sensor on skin that is painful to touch, raised (higher than surrounding skin), crusting or bleeding; or on areas with scars, tattoos or moles. Select a skin area that stays flat during normal daily activities. Choose a site that is greater than 2.5 cm (1 inch) away from any insulin injection sites. Change the Sensor Insertion Site for the Next Sensor Insertion: Placing the next sensor on the same spot will increase skin irritation or redness and could potentially lead to scabs. Excessive Sweat or Body Movement Can Cause Your Sensor to Loosen: Remove and replace your sensor if it starts to loosen. 11 Safety Information PRECAUTIONS :

Skin Irritation Reaction Caused by Sensor Adhesive: Some individuals may be sensitive to the medical adhesive that keeps the sensor attached to the skin. If you develop a rash around or under your sensor, remove the sensor and stop using the RIGHTEST CGMs. If needed, consult your health care professional. Avoid Skin Care Products or Insect Repellent: Do not apply skin care products such as sunscreens, moisturizer or perfume over the sensor insertion sites. Insect repellent may damage the plastic used in the RIGHTEST CGMs. Failure to comply may lead to inaccurate system performance. Store the Sensor in a Dry Room: Store your sensor at a temperature of 5C to 30C

(41F to 86F) and 10%~90% non-condensing humidity. You can also store the sensor in the refrigerator at 5C to 30C (41F to 86F). Do NOT freeze the sensor. DO NOT Reuse Your Inserter, Sensor, and Single-use Transmitter (HM310): The inserter is pre-loaded with a sensor. The entire sensor inserter package is sterilized and designed for single use. HM310 transmitters are designed for single-use and are not rechargeable. All RIGHTEST CGMs components are not suitable for re-sterilization. Reuse of these components may result in no glucose readings and infections. Discard Sensor Inserter in an appropriate puncture-proof or biohazard container, for safety and to prevent cross-contamination. 12 Safety Information DO NOT Share Your Re-chargeable Transmitter (HM312): The RIGHTEST CGMs HM312 transmitter is rechargeable and reusable. Never share your transmitter with others. The system is a prescription-only medical device and is meant for your use only. If used by other persons, the glucose readings, report, alerts/alarms, etc., may be wrong. Use the Charger as Directed: Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Use USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation risk. Do NOT Use If the Receiver (HR310) is Damaged, or If It Could Fall into Water. The receiver (HR310) and accessories are enclosed without protection from the ingress of water. Do not submerge these components in water. If the receiver (HR310) has fallen into water, do not touch it until you unplug it from any electrical outlet. Touching the receiver (HR310) while it is wet or damaged could result in electric shock or no glucose results. Test Your Receiver (HR310) Regularly. Test your receiver (HR310)s speaker and vibration functions regularly. If you are in any doubt, contact a manufacturer authorized dealer for technical support. Interfering Substance Risks. Acetaminophen may falsely raise sensor readings to higher than they really are. 13 Safety Information PRECAUTIONS :

Keep Your Receiver (HR310) Close. Be sure your receiver (HR310) is close to your transmitter and in the same room. The maximum transmission distance is 6 meters (20 feet) with no obstructions (e.g. wall, metal, glass or water) in between. Obstructions or longer distances may cause Bluetooth signal loss and you will not receive important alerts/alarms. Plug in to Charge. Be sure to fully charge your transmitter (HM312) every time you start with a new sensor. When plugged into an adapter that is connected to a standard household electrical outlet

(100 to 240 VAC, 50/60Hz), the transmitter battery requires approximately 2 hours to fully charge. When connected to your personal computers USB port or USB car charger adapter, it may take a longer time. To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in your receiver (HR310) to its charger at the end of the day and charge it up overnight. Going Through Security Check Points. Remove all parts of the RIGHTEST CGMs before exposing it to an X-ray machine. The effect of X-rays on the system has not been evaluated. Adequate Brightness while reading: If you have difficulty reading your receiver (HR310) in bright sunlight, you may need to seek a shady location. 14 15 Symbol Definitions III. SYMBOL DEFINITIONS The following symbols apply to the RIGHTEST Continuous Glucose Monitoring System SYMBOL DEFINITION SYMBOL DEFINITION Date of Manufacture Do not use if package is damaged Manufacturer Biological risks Authorized representative in the European Community For single use only Batch/Lot Number Type BF applied part device Expiry date Direct current Temperature limitation Alternating current Humidity limitation Medical Device MD Method of sterilization using irradiation Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. 16 Symbol Definitions SYMBOL DEFINITION SYMBOL DEFINITION Protected against insertion of fingers and dripping water. Keep Dry Protected from touch by fingers and objects greater than 12 millimeters. Protected from condensation. MR Unsafe Serial Number Prescription Required CE Mark with Notified Body Number Refer to Instruction Manual/Booklet Bluetooth Class II Equipment Input Importer Keep away from heat Electrical Equipment Designed Primarily for Indoor Use (Chargers Only) Warning/Precaution Operating Instructions; consult manual for further instructions Near-field communication (NFC) scan area 17 Getting to Know Your RIGHTEST CGMs IV. GETTING TO KNOW YOUR RIGHTEST CGMS WHAT IS INCLUDED RIGHTEST Continuous Glucose Monitoring System (with re-chargeable Transmitter) 1. SENSOR INSERTER: Designed with a pre-loaded sensor. 2. TRANSMITTER (HM312):

Rechargeable for multiple-use. 3. Receiver (HR310): Blood glucose information display. 4. POWER SUPPLY: AC power adapter & USB cable. 18 5. TRANSMITTER USB CHARGER: A USB charging dock for the transmitter (HM312). 6. STORAGE VIAL: Storage for the transmitter and transmitter USB charger to keep them dry. Getting to Know Your RIGHTEST CGMs RIGHTEST Continuous Glucose Monitoring System (with single-use Transmitter) 1. SENSOR INSERTER: Designed with a pre-loaded sensor. 2. TRANSMITTER (HM310): Non-rechargeable transmitter for single-use. 3. Receiver (HR310): Blood glucose information display. 4. POWER SUPPLY: AC power adapter & USB cable. 19 Getting to Know Your RIGHTEST CGMs PERFORMANCE FEATURES The RIGHTEST CGMs is an integrated continuous glucose monitoring system (iCGM) that provides glucose readings, trends, and levels every 5 minutes. The system is comprised of three main components: (a) a Sensor, (b) a Bluetooth Transmitter and (c) a receiver (HR310). The sensor is pre-loaded inside an Inserter. The sensor is inserted under your skin and measures your interstitial glucose level test glucose every 5 minutes. The transmitter will be either rechargeable or non-

rechargeable as chosen by the user users choices. The transmitter wirelessly sends data to the receiver (HR310) every 5 minutes. The receiver (HR310) displays glucose values and alerts users to hypoglycemia and hyperglycemia. The RIGHTEST CGMs user-friendly features and benefits include:

Ergonomic design of sensor inserter allows users to insert the sensor safely with just one hand. Easy-to-read visual glucose values and trends. Transmitters powerful storage holds 14 days of glucose readings with zero data loss. Getting visual and audible alerts to hypoglycemia and hyperglycemia. Lightweight sensor and transmitter for maximum comfort. 20 Getting to Know Your RIGHTEST CGMs SAFETY FEATURES The RIGHTEST CGMs offers a number of important safety features when you use it. These features include:

Receiver (HR310)s alarm/alert includes visual notification, vibrations and sound, depending on your personalized settings. When you are out of your target glucose range, the receiver (HR310) alerts you. Receiver (HR310) warns you if your glucose level falls below 54 mg/dL; or when your sensor reading is below 70 mg/dL and continuously falling for the following 2 readings (or 10 minutes). Urgent alert/alarm settings at 54 mg/dL or below; or below 70 mg/dL and continuously falling for the following 2 readings (or 10 minutes) cannot be changed or turned off. Receiver (HR310) notifies you when a sensor has failed, expired or when there are system errors. 21 Getting to Know Your RIGHTEST CGMs THE RIGHTEST CGMS COMPONENTS The RIGHTEST CGMs consists of 3 key parts: a Sensor, a Transmitter and a Receiver (HR310). These 3 parts are described below:

Inserter Sensor Inside SENSOR INSERTER The inserter is pre-loaded with a sensor and does not require user assembly. The inserter helps you place the sensor wire under your skin with ease. The sensor measures your glucose information. TRANSMITTER (HM312/ HM310) The transmitter sends your glucose data from the sensor to the Receiver

(HR310). The HM312 transmitter is equipped with a rechargeable battery. The HM310 transmitter internal battery is non-rechargeable. Receiver (HR310) The receiver (HR310) displays glucose values and alerts you to hypo/

hyperglycemia. 22 Getting to Know Your RIGHTEST CGMs ACCESSORIES TRANSMITTER USB CHARGER A USB charger is included with your HM312 transmitter. STORAGE VIAL The vial is used for storage of a spare transmitter and its USB charger to keep them dry. POWER SUPPLY (USB CABLE AND AC POWER ADAPTER) AC power supply & USB cable for the Receiver (HR310). It connects to an AC mains outlet (100 to 240 VAC, 50/60 Hz). 23 Before Getting Started V. BEFORE GETTING STARTED CHARGING BASICS Before using the system for the first time, charge the receiver (HR310) for a complete charging cycle without interruption. If your system comes with re-chargeable transmitters (HM312), a transmitter charger is supplied along with your transmitter package. Rechargeable transmitters (HM312) must be fully charged each time you start a new monitoring session. Otherwise, your sensor will likely not remain operational until the end date of sensor wear period (14 days). A complete charging cycle of the receiver (HR310) takes about 4 hours. For the re-chargeable transmitter (HM312) it takes about 2 hours when using the supplied USB adapter plugged into a standard household electrical outlet (100 to 240 VAC, 50/60Hz). It is recommended to use only the supplied USB cable and USB power adapter. To ensure the best performance every day, all day, plug in your receiver (HR310) to its charger at the end of the day and charge it up overnight. 24 Before Getting Started CHARGING THE Receiver (HR310) WARNINGS :

Not Getting Urgent Alarm/Alert. There are no alarm/alerts, when your receiver (HR310) is turned off or its battery is dead. Modification of The System is Not Allowed. Do not modify or tamper with any components or accessories of the RIGHTEST CGMs. Otherwise, you could damage the integrity of the system and put yourself at risk especially when you have severe low or high glucose events. PRECAUTIONS :

Use Charger as Directed. Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Plug in to Charge. To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in your receiver (HR310) to its charger at the end of the day and charge it up overnight. Do NOT Use If the Receiver (HR310) is Damaged, or If It Could Fall into Water. The Receiver (HR310) and accessories are enclosed without protection from the ingress of water. Do not submerge these components in water. If the receiver (HR310) has fallen into water, do not touch it until you unplug it from any electrical outlet. Touching the receiver (HR310) while it is wet or damaged could result in electric shock or no glucose results. 25 Before Getting Started 1. Connect the micro-USB plug of the charging cable to the mircro-USB input of the receiver (HR310). 1 26 Before Getting Started 2. Connect the USB plug to the USB port of the AC power adapter supplied with your system, and connect the adapter to the power source. Alternatively, connect plug to the USB port of your computer or USB car charger adapter. 2

* Accessories not included. 27 Before Getting Started BATTERY LIFE INDICATOR ON THE Receiver (HR310) From the receiver (HR310) display, battery level (as a percentage of full charge) and the battery status icon (charging or discharging) is displayed in the top-right corner of the screen. When the receiver (HR310) is charging, you will see lightning bolt in the middle of the battery icon. The receiver

(HR310) utilizes an intelligent battery charging technology that prevents overcharging. 28 Before Getting Started CHARGING TRANSMITTER WARNINGS :

Not Getting Urgent Alarm/Alert. There are no alarm/alerts when your transmitter battery is dead. Modification of The System is Not Allowed: Do not modify or tamper with any components or accessories of the RIGHTEST CGMs. Only use USB charging units provided by Bionime. Otherwise, you could damage the integrity of the system and put yourself at risk especially when you have severe low or high glucose events. Choking Hazard: The RIGHTEST CGMs contains small components that may be dangerous if swallowed. PRECAUTIONS Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter. Using different chargers or AC power adapter could damage the system or cause fire. Plug in to Charge. Be sure to fully charge your transmitter (HM312) every time you start with a new sensor. When plugged into a standard household electrical outlet (100 to 240 VAC, 50/60Hz), the transmitter battery requires approximately 2 hours to fully charge using the transmitter charger supplied with the RIGHTEST CGMs. When connected to your personal computers USB port or USB car charger adapter, it may take a longer time. 29 Before Getting Started It is important to charge the transmitter battery to its full charge every time before you begin with a new sensor to ensure data is collected from the sensor and sent to receiver (HR310) during entire wear period (14 days). Storage Vial 1. Take out your transmitter charger from its storage vial. Hold the charger face up. 1 2 Transmitter Charger 2. Make sure the alignment notch of the transmitter is facing the chargers transmitter compartment with the transmitter mark facing up. With the transmitter outer frame between your fingers, steadily slide the transmitter all the way into the compartment. Alignment Notch 30 3 4

* Accessories not included. Before Getting Started Lock Button

(in lock position) 3. With the transmitter securely inside its charger compartment, turn over the charger to the back side and slide the lock button outwards. 4. Plug the chargers USB plug into the USB port on the AC power adapter supplied with the RIGHTEST CGMs, then plug the AC power adapter inot the AC mains outlet (100 to 240 VAC, 50/60 Hz). You can also charge your transmitter with a computer or a car charger adapter with a USB port but it may take much longer. 31 Before Getting Started 5. When you connect the transmitter charger to a USB power source, the LED on the charger lights up. The charge condition of transmitter battery is indicated below: a solid green ( ) light means the battery is fully charged. a solid amber ( ) light means the battery is charging. 5 Fully charged Charging NOTE :

If the LED doesnt light up, make sure you connect to a power source with output rating of 500mA or higher. If this does not solve the issue, check with another power source again then contact customer support. 6. After the transmitter is fully charged, unplug the transmitter charger from the power source. 7. If you wish to take out the transmitter from its charger, or to store the transmitter charger, turn over the charger to the back side and press the lock button slightly downward, then slide the lock button all the way inward. 7 32 33 Set Up Your RIGHTEST CGMs VI. SET UP YOUR RIGHTEST CGMS Before setting up your RIGHTEST CGMs, make sure you have everything you need:

Sensor Inserter Package Alcohol Wipes Transmitter Receiver (HR310) Your Blood Glucose (BG) Meter PAIRING THE SENSOR AND TRANSMITTER USING NFC PRECAUTIONS :

Scan the NFC Tags First before Connecting to the System: Each sensor has its unique code established on the tag attached on the sensor inserter package. The transmitters code is located right beneath its top plastic cover where you see a mark. Every time you begin the use of a new sensor, scan both codes to ensure successful system connections. The system will not start if you fail to scan the codes. The following steps describe using receiver (HR310) to make a sensor-transmitter pair. If the instructions provided do not work, the receiver (HR310) will display an error message. Every time you begin the use of a new sensor, scan the codes on both the sensor inserter package and on the transmitter. The system will not start if you fail to scan the codes. 34 Set Up Your RIGHTEST CGMs 1. Get your receiver (HR310). 2. If your receiver (HR310) is OFF, press and hold the [Power] button for 2 seconds to turn ON. If your receiver (HR310) is ON, press the [Power] button briefly to wake up its display. NOTE :

If using the receiver (HR310) for the first time, follow prompts to set the date, time and your glucose target & alerts. 2 Power Button 35 Set Up Your RIGHTEST CGMs 3. Tap [Home] at the bottom of your receiver (HR310) screen. Then, tap [New Monitor] to start a new monitoring session. 3 36 Set Up Your RIGHTEST CGMs 4. When the receiver (HR310) prompts you to pair the sensor & transmitter, choose [Pair]. 4 37 Set Up Your RIGHTEST CGMs 5. Locate the NFC panel at the top of your receiver (HR310)s back cover. The center of NFC panel is engraved with a mark. 5 NFC panel 38 Set Up Your RIGHTEST CGMs 6. Tap the receiver (HR310)s NFC panel against the tag on top of the sensor inserter package until you hear a beep sound. 6 NOTE :

Be sure your receiver (HR310)s NFC panel is within 1cm (3/8) of the NFC tag/mark when you scan the codes. NFC Tag 39 Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed as by checkmark ( ) on the receiver (HR310) screen. 7 40 Set Up Your RIGHTEST CGMs 8. Tap receiver (HR310)s NFC panel against the laser engraved NFC mark on the top of transmitter until you hear a beep sound. 8 NOTE :

Be sure your receiver (HR310)s NFC panel is within 1cm (3/8) of the NFC tag/mark when you scan the codes. Laser engraved NFC mark 41 Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as by checkmark ( ) the screen. 9 42 Set Up Your RIGHTEST CGMs 10. When the receiver (HR310) displays Pairing Complete, press [Next]. 11. Make sure you follow the step-by-step instructions in the installation guide described in the next 2 sections (Apply Your Sensor and Attach Your Transmitter). After the sensor and transmitter are installed, press [Start Sensor]. 10 11 43 Set Up Your RIGHTEST CGMs APPLY YOUR SENSOR PRECAUTIONS :

Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion. This helps the sensor stay attached to your body. DO NOT Place the Sensor on Any Area of the Body other than the Upper Arm or Abdomen: Placing the sensor on other areas of the body has not been tested and the risks are unknown. Select an Appropriate Sensor Insertion Site: Do NOT place the sensor on skin that is painful to touch, raised (higher than surrounding skin), crusting or bleeding; or on areas with scars, tattoos or moles. Select a skin area that stays flat during normal daily activities. Choose a site that is greater than 1 inch (2.5 cm) away from any insulin injection sites. Change the Sensor Insertion Site for the Next Sensor Insertion: Placing the next sensor on the same spot will increase skin irritation or redness and could potentially lead to scabs. 44 Set Up Your RIGHTEST CGMs The sensor is pre-loaded inside the inserter. Before applying the sensor to your skin, get familiar with the information in this section. Overview of Sensor Inserter Sensor Base:

Holds your transmitter in place Sensor Inserter Sensor:

Inserts into your skin Adhesive Patch:

Keeps sensor and sensor base on the skin 45 Set Up Your RIGHTEST CGMs Follow these steps to apply your Sensor:

1. Choose an insertion site on the upper arm or abdomen. NOTE :

Use a different site for the next sensor insertion. 2. Wipe the insertion site with an alcohol wipe approximately for 2 minutes until the site dried out thoroughly before getting started. 3. Take out the sensor inserter from its package. Open the sensor inserter cap. 4. Place the inserter over the site and push down firmly to insert the sensor. NOTE :

Do not push down the inserter until it is placed over the insertion site. 3 4 2 46 Set Up Your RIGHTEST CGMs 5. Gently move the inserter away from your insertion site. 6. Make sure the sensor is securely attached to your skin. approximately for 2 minutes until the site dried out. 7. Discard the inserter and its package according to local regulations. 6 47 Set Up Your RIGHTEST CGMs ATTACH YOUR TRANSMITTER WARNINGS :

Choking Hazard. The RIGHTEST CGMs contains small components that may be dangerous if swallowed. PRECAUTIONS :

DO NOT Use If Any Components Appears to be Damaged or Past Its Expiration Date. A damaged or cracked inserter, sensor, transmitter, or receiver (HR310) could compromise the integrity of the system or contribute to infection risk. Do not use if your sensor has past its expiration date. The sensor expiration date is in YYYY-MM-DD (Year-Month-Day) format on your Inserter Package. DO NOT Share Your Re-chargeable Transmitter (HM312). The RIGHTEST CGMs HM312 transmitter is rechargeable and reusable. Never share your transmitter with others. The system is a prescription-only medical device and is meant for your use only. If used by other persons, the glucose readings, report, alarms/alerts, etc., may be wrong. Use Charger as Directed. Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. 48 Set Up Your RIGHTEST CGMs Plug in to Charge. Be sure to fully charge your transmitter (Model HM312) every time you start with a new sensor. When plugged into a standard household electrical outlet (100 to 240 VAC, 50/60Hz), the transmitter battery requires approximately 2 hours to fully charge using the transmitter charger supplied with the RIGHTEST CGMs. When connected to your personal computers USB port or USB car charger adapter, it may take much longer. Overview of the Transmitter Transmitter:

2 options available:

HM312. Rechargeable for multiple-use HM310. Non-rechargeable for single-use Alignment notch on the transmitter Alignment notch on the sensor base 49 Set Up Your RIGHTEST CGMs Attach your transmitter after you insert a sensor. If you are using the rechargeable transmitter (HM312), dock your spare transmitter in the transmitter charger. Store both the transmitter and its charger in the storage vial provided with your RIGHTEST CGMs. Before attaching the rechargeable transmitter (HM312), make sure it is fully charged. Do not remove your transmitter until your sensor session is over. Single-use transmitter (HM310) has sufficient battery life to function as intended. Discard the transmitter (HM310) according to local regulations after each use. Follow these steps to install your Transmitter:

1. Get your transmitter. NOTE :

If using the re-chargeable transmitter (HM312), be sure your transmitter is fully charged every time you start with a new sensor. 2 2. If necessary, clean the transmitter with an alcohol wipe. While you do so, do not touch or scratch its metal components located at the bottom. NOTE :

Wipe the bottom of transmitter with a dry cloth or an alcohol pad. Failure to clean it may cause it to deteriorate and harden over time, resulting in malfunction. 50 Set Up Your RIGHTEST CGMs 3. Let the transmitter dry. 4. Align both notches on the sensor base and transmitter. 5. Press down the transmitter until it snaps into place. 4 51 Set Up Your RIGHTEST CGMs START SENSOR WITH THE RECEIVER (HR310) WARNING :

Use a Blood Glucose (BG) Meter. During the first 2-hour sensor warm-up period when you start a new sensor, use a BG meter to make treatment decisions. You wont get any sensor readings, alarms or alerts until your system begins to transmit data. Modification of the System is Not Allowed: Do not modify or tamper with any components or accessories of the RIGHTEST CGMs. Otherwise, you could damage the integrity of the system and put yourself at risk especially when you have severe low or high glucose events. PRECAUTIONS :

Use Charger as Directed: Use only the AC power adapter, USB cable and USB charger provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter. Using different chargers or AC power adapters could damage the system or cause fire. Do NOT Use If the receiver (HR310) is Damaged, or If It Could Fall into Water. The receiver (HR310) and accessories are enclosed without protection from the ingress of water. Do not submerge these components in water. If the receiver (HR310) has fallen into water, do not touch it until you unplug it from any electrical outlet. Touching the Receiver (HR310) while it is wet or damaged could result in electric shock or no glucose results. Test Your Receiver (HR310) Regularly. Test your receiver (HR310)s speaker and vibration functions regularly. If you are in any doubt, contact a manufacturer authorized dealer for technical support. 52 Set Up Your RIGHTEST CGMs Keep Your Receiver (HR310) Close. Be sure your receiver (HR310) is close to your transmitter and in the same room. The maximum transmission distance is 6 meters (20 feet) with no obstructions (e.g. wall, metal, glass or water) in between. Obstructions or longer distance may cause Bluetooth signal loss and you will not receive important alerts/alarms. Plug in to Charge. To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in your receiver (HR310) to its charger at the end of the day and charge it up overnight. 53 Set Up Your RIGHTEST CGMs NOTE :

Make sure you go through all steps in the Pairing the Sensor and Transmitter using NFC section. Make sure that you have your sensor and transmitter installed properly before you start the following steps. 1 1. Make sure you have followed the installation guide described in the Apply your Sensor" and "Attach Your Transmitter sections. Then, when the receiver (HR310) displays Your system is about to start, press [Start Sensor]. 54 Set Up Your RIGHTEST CGMs NOTE :

If your receiver (HR310) doesnt start the search or displays a Cannot Connect to Sensor/Transmitter Pair message, go through the steps in the Pairing the Sensor and Transmitter using NFC section again. If the problem persists, refer to the troubleshooting section. 2 2. The receiver (HR310) will automatically start searching for your sensor-transmitter pair. Keep your receiver

(HR310) close to you. 55 Set Up Your RIGHTEST CGMs 3. Wait for successful connection confirmation with a graphic. 3 56 Set Up Your RIGHTEST CGMs 4. If you want to add a data security number press Learn more. If you do not want to add a security number, then proceed to step 7. 4 57 Set Up Your RIGHTEST CGMs 5. Press [Add Now] to configure your 4-digit security code. 5 58 Set Up Your RIGHTEST CGMs 6. You will be prompted to enter your personal security code. Then press [Done]. 6 59 Set Up Your RIGHTEST CGMs 7. Press [Done] then wait 2 hours for the sensor warmup. 7 NOTE :

You wont get any sensor readings, alarms or alerts until your system begins to transmit data. Use a blood glucose meter to make treatment decisions during the sensor warmup. 60 Set Up Your RIGHTEST CGMs 8. The receiver (HR310) displays the sensor warmup progress and remaining warmup time. When the sensor warmup is complete, Warmup disappears from your display. 8 61 Ending a Monitoring Session VII. ENDING A MONITORING SESSION You will receive a Sensor Expiring Soon alert on your receiver (HR310) 24 hours prior to monitoring ending. Press [OK] to confirm you have read this alert . 62 Ending a Monitoring Session 63 Ending a Monitoring Session END THE MONITORING SESSION Before you remove the sensor. Either:

Wait for the sensor to fully expire. You will receive a Sensor Expired alert and the session will end automatically. Press [OK] confirm you read this alert. 64 Ending a Monitoring Session End the monitoring session early by selecting the [Stop Sensor] option in My menu. You will see a message warning you that the sensor has not expired yet. Press [Stop Anyway] to end the session. 65 Ending a Monitoring Session SENSOR AND TRANSMITTER REMOVAL Once the session has ended, follow these steps to remove your sensor and transmitter:

1. Grip the edge of the patch attached to your skin. Slowly pull upwards to peel it off. 2. Pick up the sensor base and transmitter. Note that one edge of the base has a notch. 3. Locate a point two-thirds along the length of the base and across from the notch. Then pinch firmly at this point with your thumb and index fingers. While you do so, grip a corner of the notched edge of the sensor base with your other hand. 4. Press down firmly with both your hands to bend the base away from the transmitter. 5. The transmitter will pop out as you bend the base. You will hear a click as the transmitter detaches. 6. Discard the sensor according to local regulations. NOTE :

Do not throw away a HM312 Transmitter. HM312 Transmitters are reusable after recharging. You may discard disposable HM310 transmitters. 66 1 3 Ending a Monitoring Session 4 67 Understand Your Glucose Readings VIII. UNDERSTAND YOUR GLUCOSE READINGS Your sensor glucose readings appear on your receiver (HR310) displays Home screen. It is important to understand your readings. HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW Your glucose information (e.g. reading, glucose graph, trend arrow indicating rates and direction of glucose change. etc.) is displayed on your receiver (HR310)s Home screen. It is important to understand these indicators before use. An overview of the home screen is shown below. 68 Understand Your Glucose Readings Overview of Receiver (HR310) Home Screen Sounds & Vibration System connection status Glucose High/Low Alerts Check Blood Glucose When you see this symbol, you must check your blood glucose value with a meter before making any treatment decisions. Current Time Receiver (HR310) battery level Days until sensor expiration Trend Arrow Glucose Reading Transmitter level Most recent data point Target Glucose Range Add Notes 69 Understand Your Glucose Readings GLUCOSE INFORMATION Your most recent glucose reading is displayed inside a circle with an arrow on top of the receiver

(HR310) screen. The arrow shows the direction of your glucose trend. A symbol reminds you to do a fingerstick blood glucose test before making treatment decisions. You will see this symbol in each of the following situations:

Your glucose is less than 70 mg/dL regardless of your projected trend direction. Your glucose is rising or falling rapidly at or more than 2 mg/dL per minute. There is no glucose value or trend arrow (HIGH/LOW event). During the first 2 hour sensor warmup period. The sensor glucose concentration reading range is 40 - 500 mg/dL. A glucose alert safety symbol

( or ) will appear in the following situations:

When your glucose is at or higher than 250 mg/dL, and is projected to rise or remain steady. When your glucose is at or less than 70 mg/dL, and is projected to fall or remain steady. 70 Understand Your Glucose Readings Fingerstick Check and Alerts/Message Glucose High/Low Alerts Glucose message Check Blood Glucose When you see this symbol, you must check your blood glucose value with a meter before making any treatment decisions. 71 Understand Your Glucose Readings GLUCOSE TREND ARROW AND ARROW COLOR There are 5 different trend arrows reflecting your glucose readings and how fast they are changing. The color (orange, amber, green, rouge and red) of the arrow helps identify the risk of hypoglycaemia and hyperglycaemia. 72 Understand Your Glucose Readings Direction What it means Glucose is steady*

Glucose rising**

Glucose rising rapidly***

Glucose falling**

Glucose falling rapidly***

Arrow Color ORANGE:

>250 mg/dL AMBER 181 - 250 mg/dL GREEN:

70 - 180 mg/dL ROUGE:

54 - 69 mg/dL RED:

<54 mg/dL

*glucose is steady means the glucose rate of change is in between 0 to 1 mg/dL.

**glucose falling/rising means the glucose rate of change is in 1 - 2 mg/dL per minute.

***glucose falling/rising rapidly means the glucose rate of change is at or more than 2 mg/dL per minute. 73 Understand Your Glucose Readings TREND GRAPH The trend graph is displayed on the lower portion of the screen. It shows your glucose trend for the past 6 hours. The graph adds one reading every 5 minutes. The most recent data point is marked by an open-target double circle at the right end of the plot. The sensor glucose reading range is 40 - 500 mg/dL. The trend graph uses a dynamic range of 0 - 500 mg/dL. The default graph displays a range of 0 - 250 mg/dL and is able to reproduce the maximum range as required when taking actual readings. Overview of Trend Graph Default Graph Range: 0 - 250 mg/dL Note logs 74 Understand Your Glucose Readings Reproduced Graph Range: 0 - 500 mg/dL Note logs Most Recent Reading High Target Low Target Add Notes 75 Understand Your Glucose Readings ADD NOTES 1. From the Home screen, add a note by tapping the symbol in the lower right corner of the screen. 1 76 Understand Your Glucose Readings 2. Make sure the time is correct. 3. Select the options (carbs, insulin, exercise) then follow the prompts. You can type in other details such as meals, food or medication you take. 4. Tap to save your notes. Notes are viewable in your logbooks. 2 3 4 77 Understand Your Glucose Readings ACCESS YOUR NOTES INFORMATION Personal notes (insulin, meals, exercise) are marked by blue triangle on the bottom of the graph. If you performed calibration, the calibration record (if accepted) is marked with a blue target symbol and is viewable in the note. To access your sensor glucose information or to view your personal notes from anytime between the first and most recent reading, hold and drag the trend graph left or right. Note entries will be displayed on the upper portion of the receiver (HR310) screen. The screen will return to the Home screen showing the most recent glucose information after 2 minutes of non-

use. Alternatively, tap the [Back] button. 78 Understand Your Glucose Readings Note Date/Time Events Glucose reading at selected point in time Calibration History at selected point in time Hold and drag left or right on the graph Calibration Symbol 79 Understand Your Glucose Readings HIGH/LOW READING If HIGH appears on your receiver (HR310) screen, your glucose reading is above 500 mg/dL. Do a fingerstick blood glucose test with a BG meter. If you also get a HIGH result (>500 mg/dL) from the meter test, contact your healthcare practitioner immediately. If LOW appears on your receiver (HR310) screen, your glucose reading is less than 40 mg/dL. Do a fingerstick blood glucose test with a BG meter. If you also get a LOW result (<40 mg/dL) from the meter test, contact your healthcare practitioner immediately. 80 Understand Your Glucose Readings HIGH/LOW Reading 81 Review Your Glucose History IX. REVIEW YOUR GLUCOSE HISTORY Your receiver (HR310) will record and analyze up to 90 days of glucose data using Ambulatory Glucose Profile (AGP) techniques. Make sure you have data for at least 7 - 10 days (ideally more than 14 days) to identify your glucose patterns. The 7 days, 14 days, 30 days and 90 days result of AGP analysis can be reviewed on the Report page. From the Report screen, choose the duration of your glucose summary statistics to review on the upper portion. By pooling data from multiple days, graphs showing the 24-hour glucose level percentage and daily glucose level are shown below. 82 Glucose History Review Your Glucose History Choose a report duration from here!

83 Calibration (Optional) X. CALIBRATION (OPTIONAL) Your RIGHTEST CGMs features factory-calibration that calculated correction factors based on factory input reference values. The system does not need user calibration and you will not receive any calibration prompts from your receiver (HR310). Calibrating your RIGHTEST CGMs is optional. The calibration option allows alignment between your system readings and your meter values. WARNINGS :

DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend arrow. If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. 84 Calibration (Optional) 1 If you are experiencing rapid glucose changes

(more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver

(HR310) display, you must check your BG value with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. CALIBRATE When you calibrate, take a fingerstick measurement from your BG meter then enter the value according to the following steps:

1. From the Calibrate screen, tap [Calibrate Now]. 85 Calibration (Optional) 2. Enter the exact BG value then press [Next]. If incorrect, tap the backspace key on the numeric keypad to erase the entries then enter the correct value. 2 NOTE :

Make sure you enter the exact value that is measured with 5 minutes. 86 Calibration (Optional) 3. You will see a prompt from receiver (HR310). Tap [Yes]

or [No]. 4. The messages on the right side of the Calibrate screen display the calibration progress and whether your entry is accepted or not. 4 3 87 Treatment Decisions XI. TREATMENT DECISIONS Before you start using the RIGHTEST CGMs for treatment decisions, make sure you are familiar with the tips provided in this chapter and you have a good understanding of how the system works. Continue to use your blood glucose meter for treatment decisions until you are comfortable with the information you receive. Getting familiar with the system could take days, weeks, or even months. Work with your healthcare practitioner and follow his/her recommendation to put together a plan for making treatment decisions. Trace your note logs often to see how carbs, medication, exercise, illness, or stress levels impact your sensor glucose reading. 88 Treatment Decisions WARNINGS :

DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not match what you are feeling, use your blood glucose meter; or, if needed, consult your healthcare practitioner. Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following Conditions:

During the first 2-hour warmup period when you start a new sensor. You wont get any sensor readings, alarm/alerts until your system begins to transmit data. If you suspect that your sensor readings may be inaccurate for any reason. If your sensor readings do not match what you are feeling. If you are experiencing symptoms that may be due to low or high blood glucose. If your sensor readings do not include your current glucose concentration or a glucose trend arrow. If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor readings displayed may be less accurate and not as timely. When you see the symbol on your receiver (HR310) display, you must check your sensor reading with a BG meter before making any treatment decisions. Sensor readings may be less accurate and may not reflect your current glucose levels. 89 Treatment Decisions WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS You must NOT make treatment decisions based on your sensor glucose reading in the following situations:

When to NOT Make a Treatment Decision When you suspect that your sensor blood glucose readings may be inaccurate for any reason. When your sensor blood glucose readings do not match what you are feeling. When you are experiencing symptoms that may be due to low or high blood glucose. If you have taken acetaminophen (Tylenol) medications within 6 hours of decision making. When the Receiver (HR310) displays no glucose information (e.g. an interrupt alert). 90 Treatment Decisions When to NOT Make a Treatment Decision Whenever you see this symbol on your screen, Glucose is Falling/Rising Rapidly (with upwards/ downward pointing arrow): Glucose measured in interstitial fluid may differ substantially from blood glucose levels, particularly at times of rapid glucose change (e.g. after meals, taking insulin, or exercising). do a fingerstick blood glucose test and make treatment decisions based on that result. Low Glucose or Urgent Low Message: Sensor glucose readings may not accurately reflect your blood glucose. No Glucose Trend Arrow: During the first 2-hour warmup period when you start a new sensor, the system cannot tell you if your glucose is rising quickly or falling quickly. No Current Glucose Concentration and Trend Arrow: When there is a HIGH/LOW result, you dont have enough information to make a treatment decision. 91 Treatment Decisions TREND ARROWS AND TREATMENT DECISIONS Trend arrows show the direction and rate of change of your glucose to give you an idea of where your glucose is going. The following table gives you some ideas on how you may use the arrows when considering your treatment. NEVER make a treatment decision based on the RIGHTEST CGMs alone. Trend Arrow Treatment Decision Low Glucose

(<70 mg/dL) Glucose in Target Range High Glucose

(>250 mg/dL)

(No Trend Arrow) 0upward arrow You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs.

(All Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. 92 Treatment Decisions Trend Arrow Treatment Decision 45 upward arrow Low Glucose

(<70 mg/dL)

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. Glucose in Target Range High Glucose

(>250 mg/dL)

(No Trend Arrow) If you are about to eat, take insulin to cover your meal. Consider increasing your dose a little since your glucose is rising. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. Avoid Insulin stacking.

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider increasing your dose a little since your glucose is high and rising. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. If you have not recently taken insulin and have finished exercise, consider adjusting your insulin correction dose upwards. Avoid Insulin stacking. 93 Treatment Decisions Trend Arrow Horizontal arrow Trend Arrow Glucose in Target Range Low Glucose

(<70 mg/dL) High Glucose

(>250 mg/dL)

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. If you are about to eat, take insulin to cover your meal. If youve recently taken insulin or are about to exercise, do nothing and check your sensor reading later. Avoid Insulin stacking.

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider increase your dose a little since your glucose is high. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. If you have not recently taken insulin and have finished exercise, consider adjusting insulin correction dose upwards. Avoid Insulin stacking. 94 Treatment Decisions Trend Arrow Trend Arrow 45 downward arrow Low Glucose

(<70 mg/dL) Glucose in Target Range High Glucose

(>250 mg/dL)

(Rouge/Red Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. If you are about to eat, take insulin to cover your meal. Consider taking a lower dose since your glucose is falling. If youve recently taken insulin or have finished exercise, eat some snacks or fast-acting carbs.

(Orange Arrow Color) If you are about to eat, take insulin to cover your meal. Consider taking a lower dose since your glucose is falling. If youve recently taken insulin or are about to exercise, do nothing and check your glucose reading later. Avoid Insulin stacking. 90 downward arrow

(All Arrow Colors) You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs. 95 Specifications XII. RIGHTEST CONTINUOUS GLUCOSE MONITORING SYSTEM SPECIFICATIONS Sensor Inserter Specifications Sensor Glucose Range 40 - 500 mg/dL Sensor Useful Life up to 14 days Sensor Inserter Shelf Life 12 months Sensor Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Sensor Ingress Protection Rating

(when installed with a transmitter) IP47 Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. Inserter Storage & Transportation Conditions Temperature: 5C - 30C (41F - 86F) Relative humidity: 10% - 90% (in a cool, dry place) Operating and Storage Altitude 0 to 3048 metres (0 to 10,000 ft) 96 Specifications Inserter Size Sterilization Usage 51.8 mm*57.0 mm*61.3 mm (+/- 0.5 mm) Sterilized by radiation Single use (disposable) 97 Specifications Transmitter Specifications Model HM312 HM310 Transmitter Size 32.8 mm x 19.8 mm x 4.15 mm (+/- 0.5 mm) Transmitter Weight 3.2g with battery (+/- 0.5 g) Power Source Rechargeable lithium battery

(3.5 ~ 4.2V/25mA) CR 1225 Lithium Battery Storage Transportation &

Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Operating and Storage Altitude 0 to 3048 metres (0 to 10,000 ft) Battery Run Time Up to 25 days (based on full charge) Up to 20 days (single use) Power Charging Time 2 hours (via AC adapter) Non-rechargeable 98 Specifications Model Memory Storage Ingress Protection Rating

(when attached to Sensor) HM312 HM310 14 days of glucose data

(glucose readings stored every 5 minutes) 14 days of glucose data

(glucose readings stored every 5 minutes) IP 47 Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth. Protection Against Electrical Shock Type BF applied part Data Communication Bluetooth 4.2 Data Communication Range Up to 6 meters (20 feet) 99 Specifications Receiver (HR310) Specifications Dimension Weight Touch Screen Size Power Source Memory Storage Battery Longevity 122*65*12 mm (+/- 0.5 mm) 124.5 g with battery (+/- 0.5 g) 4 inches Up to 90 days (typical use) 3 days (typical use) Rechargeable lithium battery; Input: 5V DC/1A Battery Charging Time 4.5 hours (via AC adapter) Storage Transportation & Operating Conditions Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Alarm Output Sound Speaker; Vibration Data Communication Glucose data transfer: Bluetooth 4.2 System pairing: NFC pairing Charging Port USB type C 100 Ingress Protection Rating Power Supply Compatible AC Power Adapter Specifications IP22 Protection against insertion of fingers and objects greater than 12.5 millimeters. Protection against dripping water when tilted up to 15. Input: 100 - 240V ~ 50 - 60Hz, 0.2A Output: DC5.0V, 1.0A, 5.0W Operating temperature: 0 ~ 45 Output: DC5.0V, 0.01-3.00 A, 15W Model: UES18LCPU-XXXYYYSPA Manufacturer: Dongguan Shilong Fuhua Electronic Co., Ltd. 101 Transmitter Charger Specifications (for Transmitter model HM312) Charger Channel 1 Charger Dimensions 40*26*23 mm (+/- 0.5 mm) LED (Green/ Amber) USB Type A 25 g (+/- 0.5 g) DC 5V/18 ~20 mA DC 4.2V/18 ~20 mA Specifications Indicator Input Port Weight Input Output Storage Conditions Operation Conditions Ingress Protection Rating 102 Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

Temperature: 5C - 45C (41F - 113F) Relative humidity: 10% - 90%

IP21 Protected from touch by fingers and objects greater than 12.5 millimeters. Protected from condensation. Specifications Frequency range BLE : 2402~2480MHz / RFID: 13.56 MHz Maximum RF output power of the product -5.37 dBm Versions of software : HR310_0.9.0.0 Versions of firmware : HM312_A001 / HR310_A001 103 Certificate Statement XIII. CERTIFICATE STATEMENT RF STATEMENT This device has been evaluated to meet general RF exposure requirements. The device can be used in a portable exposure condition without restrictions. FCC STATEMENT This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference; and

(2) This device must accept any interference received, including interference that may cause undesired operation. NOTE :

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and Regulations. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause interference to radio frequency communications. There is no guarantee that interference will not occur in a particular installation. 104 Certificate Statement Turning the equipment on and off in proximity to a radio or television will determine whether the equipment is causing interference to signal reception. If interference is present, the user is encouraged to attempt to resolve it by one or more of the following methods:

Reorient or reposition the receiving antenna. Increase the separation between the equipment and the receiving device. Connect the equipment to a different power outlet than the receiving device. Consult the dealer or an experienced radio or television technician. CAUTION :

Any changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 105 Certificate Statement NCC STATEMENT This device is compliant with Article 12 and Article 14 of the Administrative Regulations on Low Power Radio Waves Radiated Devices. Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to a approved low power radio-frequency devices. 106 Certificate Statement Article 14 The low power radio-frequency devices shall not influence aircraft security and interfere legal communications; If found, the user shall cease operating immediately until no interference is achieved. The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. 107 Appendix XIV. APPENDIX: ALARM/ALERTS Receiver (HR310): GLUCOSE AND SIGNAL LOSS ALERTS Screen Event Very High Glucose:

> 250 mg/dL and when the glucose is projected to rise or remain steady. Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes Sound & Vibration Alert : ON Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 108 Screen Event Low Glucose:

55 - 70 mg/dL and when the glucose is projected to fall or remain steady. Appendix Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes Sound & Vibration Alert : ON Editable Setting:

Sound & Vibration can be turned ON/OFF by the user. 109 Event Urgent Low Glucose: 54 mg/dL Visual & Sound Settings Default Setting:

Visual Safety Symbol ( ) on Home Screen: Yes Sound & Vibration Alert : ON Editable Setting:

NO Appendix Screen 110 Screen Appendix Visual & Sound Settings Visual glucose check symbol

( ) on Home Screen Home Screen: Yes Sound & Vibration Alert : ON Editable Setting:

NO Event 1. < 70 mg/dL regardless of the projected trend direction. 2. Glucose rising or falling at or more than 2 mg/dL per minute. 3. When there is no glucose value or trend arrow (High/

Low). 4. During the first 2 hour sensor warmup period. 111 Event Transmitter is too far from the receiver (HR310) or when there is an obstacle (e.g. water, wall) in between transmitter and receiver

(HR310). Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : ON System attempts to reconnect every 5 minutes even if user doesnt press [OK]

Editable Setting:

NO Appendix Screen 112 Appendix Screen Event Receiver (HR310) battery less than 20%. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : No 113 Event Receiver (HR310) battery less than 10%. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes Appendix Screen 114 Appendix Screen Event Transmitter battery voltage less than 3.5V (10%) Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes 115 Event 1. Receiver (HR310) scan distance is toofar (>1cm) away from the NFCtag/mark. 2. When the NFC tag/mark is damaged. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert: No Appendix Screen 116 Screen Appendix Event 1. Transmitter is too far from the receiver (HR310) or there is an obstacle (e.g. water, wall) in between transmitter and receiver (HR310). 2. Transmitter battery empty. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : No

[Try again] reconnection attempted Max. 10 times. 117 Event When receiver (HR310) make 10 attempts to reconnect to sensor-

transmitter pair but still fails. Visual & Sound Settings Default Setting:

Visual message on the screen: Yes Sound & Vibration Alert : No Appendix Screen 118 Screen Event Transmitter is not working. Appendix Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes 119 Event Transmitter detects a current error measured by the sensor. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert: Yes Appendix Screen 120 Appendix Screen Event Transmitter temperature is too high. Temporary Issue. Move to a cooler environment below 45C and wait up to 3 hours. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes 121 Event When sensor is to be expired in less than 24 hours. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert: No Appendix Screen 122 Screen Event Your sensor session is expired. Default Setting:

Visual & Sound Settings Appendix Visual message on the screen:

Yes Sound & Vibration Alert : Yes 123 Event When transmitter detects a sensor that has been used. Visual & Sound Settings Default Setting:

Visual message on the screen:

Yes Sound & Vibration Alert : Yes Appendix Screen 124 125 Appendix CUSTOMER SERVICE We sincerely like to provide complete, considerate services to our customers. Please review all the instructions to make sure you are performing the steps correctly. If you have any questions or in case of problems with the RIGHTEST Continuous Glucose Monitoring System, please contact your local Bionime customer service. If you are in the serious incidents caused by the RIGHTEST product, please call local emergency service for help. Please feel free to report your incident to us and the local competent authority. WARRANTY The manufacturer warrants that your RIGHTEST Receiver (HR310), rechargeable Transmitter will be free from defects in materials and workmanship for one year from the date of purchase. This warranty does not apply to the performance of a RIGHTEST product that has been altered, misused, tampered with or abused in any way. This warranty applies only to the original purchaser of the Rightest CGMs Products. Please complete and return the enclosed warranty card to your local Bionime affiliate. If any of the RIGHTEST CGMs Products are exposed to a high temperature difference, please wait for 30 minutes before measurement. 126

OS 09 ww OL 02 O s oo a ee RIGHTEST Hanae ences Continuous Glucose Monitoring System [gn] ymaszemnomoaied FCC ID: ADU-HM312_ 3 { }

LB 2 B ECccosmryz ogy ly}

121

OS 09 ww OL 02 O s oo a ee RIGHTEST Hanae ences Continuous Glucose Monitoring System [gn] ymaszemnomoaied FCC ID: ADU-HM312_ 3 { }

LB 2 B ECccosmryz ogy ly}

121

{This letter must be prepared on applicant/manufacturer letterhead}

Confidentiality Letter Date: 2021-02-19 Subject: Confidentiality Request for FCC ID: ADU-HM312;

Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term XX] Permanent Block Diagrams

[] Short Term External Photos LJ Short Term (] Permanent Internal Photos

[_] Short Term XX] Permanent Operation Description/Theory of Operation

(_] Short Term KX] Permanent Part List/Tune-Up Procedure

(_] Short Term X] Permanent Schematics

(_] Short Term Test Setup Photos

(_] Short Term ["] Permanent Users Manual BIONIME CORPORATION has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-

1705. Sincerely, vby: Al ex. Teen y Alex Tseng

(Si gnatlire/Title) (Print name)

Company Letter Authority to Act as Agent Date: 2020-03-03 TUV Rheinland Group 762 Park Avenue Youngsville, NC 27596 To Whom It May Concern:

I appoint TUV Taiwan to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. | also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canadas regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, 1 acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TUV Rheinland Group, still resides with BIONIME CORPORATION / No. 100. See. 2. Daging St.. South Dist.. Taichung City 4024? Taiwan For TCB applications, We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b). to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Expiration Date: 12. months By : Alex [een Alex Tseng

+ (Print Name) Title Assistant Manager Telephone: 886-4-23692388 ext. 3326 On behalf of: BIONIME CORPORATION

(Company Name) QF094234 Page 1 of 1 Revision 0

Transmitter (HM312) version 2.6 revision instructions 2.5 2.6 Difference description:

1. The first place is the NFC connection location. 2. The second place is the connection point of the motherboard. 3. The third place is connected to the battery pin. 4. PCB version modification, sensing circuit modification, integration of NFC circuit into the main board.

ele

{This letter must be prepared on applicant/manufacturer letierhead}

Confidentiality Letter Date: 2020-03-03 Subject: Confidentiality Request for FCC ID: ADU - HM312;

Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit

(_] Short Term (&] Permanent Block Diagrams Short Term External Photos

|_| Short Term [_] Permanent Internal Photos

|_| Short Term J Permanent Operation Description/Theory of Operation

(J Short Term >] Permanent Part List/Tune-Up Procedure

[| Short Term [X] Permanent Schematics

(J Short Term Test Setup Photos L_| Short Term [_] Permanent Users Manual BIONIME CORPORATION has spent substantial effort in developing this product and it is one of the first of its kind in industry, Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of | 80 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-

1705. Sincerely, By: Alex Ley Alex Tseng Tithe)

(Signatur (Print name)