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BIONIME RIGHTEST HR310 User Manual

Continuous glucose monitoring system
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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
Continuous Glucose
Monitoring System
User Manual
Use with a receiver

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Marlene Shillong
February 20, 2025

I have a Rightest meter to test my sugar level. I do not have a charger. Other chargers are not suitable. Where can I buy one please

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Summary of Contents for BIONIME RIGHTEST HR310

  • Page 1 Continuous Glucose Monitoring System BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan BIONIME GmbH User Manual Tel: +886 4 2369 2388 Tramstrasse 16 Fax: +886 4 2261 7586 9442 Berneck http://www.bionime.com Switzerland Use with a receiver E-mail: info@bionime.com...
  • Page 3 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.

  • Page 4: Table Of Contents

    CONTENTS 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.
  • Page 5 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...
  • Page 6 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...

  • Page 7: Indications For Use & Statement And Advisory

    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.

  • Page 8: Safety Information

    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.
  • Page 9 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;...
  • Page 10 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.
  • Page 11 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.
  • Page 12 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.
  • Page 13 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.
  • Page 14 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.
  • Page 15 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.

  • Page 17: Symbol Definitions

    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 For single use only the European Community Batch/Lot Number Type BF applied part device...
  • Page 18 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 MR Unsafe 12 millimeters. Protected from condensation. Serial Number Prescription Required CE Mark with Notified Body Number Refer to Instruction Manual/Booklet Bluetooth Electrical Equipment Designed Primarily...

  • Page 19: Getting To Know Your Rightest Cgms

    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.
  • Page 20 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.

  • Page 21: Performance Features

    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.

  • Page 22: Safety Features

    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. •...

  • Page 23: The Rightest Cgms Components

    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 INSERTER The inserter is pre-loaded with a sensor and does not require user assembly.

  • Page 24: Accessories

    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 &...

  • Page 25: Before Getting Started

    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.

  • Page 26: Charging The Receiver (Hr310)

    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.
  • Page 27 Before Getting Started 1. Connect the micro-USB plug of the charging cable to the mircro-USB input of the receiver (HR310).
  • Page 28 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.

  • Page 29: Battery Life Indicator On The Receiver (Hr310)

    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.

  • Page 30: Charging The Transmitter

    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.
  • Page 31 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.
  • Page 32 Before Getting Started 3. With the transmitter securely inside its charger compartment, turn Lock over the charger to the back side and slide the lock button outwards. Button (in lock position) 4. Plug the charger’s 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).
  • Page 33 Before Getting Started 5. When you connect the transmitter charger to a USB power source, the LED Fully charged on the charger lights up. The charge condition of transmitter battery is Charging indicated below: a solid green ( ) light means the battery is fully charged. a solid amber ( ) light means the battery is charging.

  • Page 35: Set Up Your Rightest Cgms

    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 • Transmitter • Receiver (HR310) • Alcohol Wipes • 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...
  • Page 36 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 &...
  • Page 37 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.
  • Page 38 Set Up Your RIGHTEST CGMs 4. When the receiver (HR310) prompts you to pair the sensor & transmitter, choose [Pair].
  • Page 39 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. NFC panel...
  • Page 40 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. NOTE : Be sure your receiver (HR310)’s NFC panel is within 1cm (3/8”) of the NFC tag/mark when you scan the codes.
  • Page 41 Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed as by checkmark ( √ ) on the receiver (HR310) screen.
  • Page 42 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. NOTE : Be sure your receiver (HR310)’s NFC panel is within 1cm (3/8”) of the NFC tag/mark when you scan the codes.
  • Page 43 Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as by checkmark ( √ ) the screen.
  • Page 44 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].

  • Page 45: Apply Your Sensor

    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.
  • Page 46 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 Inserter Sensor: Inserts into your skin Sensor Base: Adhesive Patch: Holds your transmitter in place Keeps sensor and sensor...
  • Page 47 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.
  • Page 48 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.

  • Page 49: Attach Your Transmitter

    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.
  • Page 50 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.
  • Page 51 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.
  • Page 52 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.

  • Page 53: Start Sensor With The Receiver (Hr310)

    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 won’t get any sensor readings, alarms or alerts until your system begins to transmit data.
  • Page 54 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.
  • Page 55 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.
  • Page 56 Set Up Your RIGHTEST CGMs NOTE : If your receiver (HR310) doesn’t 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.
  • Page 57 Set Up Your RIGHTEST CGMs 3. Wait for successful connection confirmation with a graphic.
  • Page 58 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.
  • Page 59 Set Up Your RIGHTEST CGMs 5. Press [Add Now] to configure your 4-digit security code.
  • Page 60 Set Up Your RIGHTEST CGMs 6. You will be prompted to enter your personal security code. Then press [Done].
  • Page 61 Set Up Your RIGHTEST CGMs 7. Press [Done] then wait 2 hours for the sensor warmup. NOTE : You won’t 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.
  • Page 62 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.

  • Page 63: Ending A Monitoring Session

    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 .
  • Page 64 Ending a Monitoring Session...
  • Page 65 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.
  • Page 66 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.

  • Page 67: Sensor And Transmitter Removal

    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.
  • Page 68 Ending a Monitoring Session...

  • Page 69: Viii.understand Your Glucose Readings

    Understand Your Glucose Readings VIII. UNDERSTAND YOUR GLUCOSE READINGS Your sensor glucose readings appear on your receiver (HR310) display’s 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.
  • Page 70 Understand Your Glucose Readings Overview of Receiver (HR310) Home Screen Sounds & Vibration Current Time Receiver (HR310) battery level System connection status Days until sensor expiration Glucose High/Low Alerts Trend Arrow Glucose Reading Check Blood Glucose Transmitter level When you see this symbol, you must check your blood Most recent data point...

  • Page 71: Glucose Information

    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. 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: •...
  • Page 72 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.

  • Page 73: Glucose Trend Arrow And Arrow Color

    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.
  • Page 74 Understand Your Glucose Readings Direction What it means Glucose is Glucose Glucose rising Glucose Glucose falling steady* rising** rapidly*** 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”...

  • Page 75: Trend Graph

    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.
  • Page 76 Understand Your Glucose Readings Reproduced Graph Range: 0 - 500 mg/dL Most Recent Reading High Target Low Target Note logs Add Notes...

  • Page 77: Add Notes

    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.
  • Page 78 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.

  • Page 79: Access Your Notes Information

    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.
  • Page 80 Understand Your Glucose Readings Glucose reading at Note Date/Time selected point in time Calibration History at Events selected point in time Hold and drag left or right on the graph Calibration Symbol...

  • Page 81: High/Low Reading

    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.
  • Page 82 Understand Your Glucose Readings HIGH/LOW Reading...

  • Page 83: Review Your Glucose History

    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.
  • Page 84 Review Your Glucose History Glucose History Choose a report duration from here!

  • Page 85: Calibration (Optional)

    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.

  • Page 86: Calibrate

    Calibration (Optional) • 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.
  • Page 87 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. NOTE : Make sure you enter the exact value that is measured with 5 minutes.
  • Page 88 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.

  • Page 89: Treatment Decisions

    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.
  • Page 90 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: •...

  • Page 91: When Not To Use Sensor Readings When Making 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 • When you suspect that your sensor blood glucose readings may be inaccurate for any reason. •...
  • Page 92 Treatment Decisions When to NOT Make a Treatment Decision • Whenever you see this Glucose is Falling/Rising Rapidly (with upwards/ downward pointing symbol on your screen, 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).

  • Page 93: Trend Arrows And 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.
  • Page 94 Treatment Decisions Trend Arrow Treatment Decision Low Glucose Glucose in Target Range High Glucose (<70 mg/dL) (>250 mg/dL) 45° upward (Rouge/Red Arrow (No Trend Arrow) (Orange Arrow Color) arrow Colors) You will see • If you are about to eat, •...
  • Page 95 Treatment Decisions Trend Arrow Trend Arrow Low Glucose Glucose in Target Range High Glucose (<70 mg/dL) (>250 mg/dL) Horizontal (Rouge/Red Arrow • If you are about to eat, (Orange Arrow Color) arrow Colors) You will take insulin to cover your •...
  • Page 96 Treatment Decisions Trend Arrow Trend Arrow Low Glucose Glucose in Target High Glucose (<70 mg/dL) Range (>250 mg/dL) 45° downward (Rouge/Red Arrow • If you are about (Orange Arrow Color) arrow Colors) You will to eat, take insulin • If you are about to eat, take insulin symbol.

  • Page 97: Xii. Rightest Continuous Glucose Monitoring System Specifications

    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 Temperature: 5°C - 45°C (41°F - 113°F) Sensor Operating Conditions Relative humidity: 10% - 90% IP47 Sensor Ingress Protection Rating...
  • Page 98 Specifications Inserter Size 51.8 mm*57.0 mm*61.3 mm (+/- 0.5 mm) Sterilization Sterilized by radiation Usage Single use (disposable)

  • Page 99: Transmitter Specifications

    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 CR 1225 Lithium Battery (3.5 ~ 4.2V/25mA) Storage Transportation & Temperature: 5°C - 45°C (41°F - 113°F) Operating Conditions Relative humidity: 10% - 90%...
  • Page 100 Specifications Model HM312 HM310 Memory Storage 14 days of glucose data 14 days of glucose data (glucose readings stored every (glucose readings stored every 5 minutes) 5 minutes) Ingress Protection Rating IP 47 (when attached to Sensor) Protected from tools and small wires greater than 1 millimeter. Protected from immersion between 15 centimeters and 1 meter in depth.

  • Page 101: Receiver (Hr310) Specifications

    Specifications Receiver (HR310) Specifications Dimension 122*65*12 mm (+/- 0.5 mm) Weight 124.5 g with battery (+/- 0.5 g) Touch Screen Size 4 inches Power Source Rechargeable lithium battery; Input: 5V DC/1A Memory Storage Up to 90 days (typical use) Battery Longevity 3 days (typical use) Battery Charging Time 4.5 hours (via AC adapter)
  • Page 102 Specifications IP22 Protection against insertion of fingers and objects greater Ingress Protection Rating than 12.5 millimeters. Protection against dripping water when tilted up to 15°. Input: 100 - 240V ~ 50 - 60Hz, 0.2A Power Supply Output: DC5.0V, 1.0A, 5.0W Operating temperature: 0°...

  • Page 103: Transmitter Charger Specifications

    Specifications Transmitter Charger Specifications (for Transmitter model HM312) Charger Channel Indicator LED (Green/ Amber) Input Port USB Type A Weight 25 g (+/- 0.5 g) Charger Dimensions 40*26*23 mm (+/- 0.5 mm) Input DC 5V/18 ~20 mA Output DC 4.2V/18 ~20 mA Temperature: 5°C - 45°C (41°F - 113°F) Storage Conditions Relative humidity: 10% - 90%...
  • Page 104 Specifications Frequency rangeà BLE : 2402~2480MHz / RFID: 13.56 MHz Maximum RF output power of the productà -5.37 dBm Versions of softwareà : HR310_0.9.0.0 Versions of firmwareà : HM312_A001 / HR310_A001...

  • Page 105: Xiii.certificate Statement

    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;...
  • Page 106 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: •...

  • Page 107: Ncc Statement

    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. 低功率電波輻射性電機管理辦法 第十二條 經型式認證合格之低功率射頻電機，非經許可，公司、商號或使用者均不得擅自變更頻 率、加大功率或變更原設計之特性及功能。 第十四條 低功率射頻電機之使用不得影響飛航安全及干擾合法通信；經發現有干擾現象時，應立 即停用，並改善至無干擾時方得繼續使用。 前項合法通信，指依電信法規定作業之無線電通信。低功率射頻電機須忍受合法通信或工業、科學 及醫療用電波輻射性電機設備之干擾。 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.
  • Page 108 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.

  • Page 109: Xiv.appendix: Alarm/Alerts

    Appendix XIV. APPENDIX: ALARM/ALERTS Receiver (HR310): GLUCOSE AND SIGNAL LOSS ALERTS Screen Event Visual & Sound Settings Very High Glucose: Default Setting: > 250 mg/dL and when the • Visual Safety Symbol ( ) on glucose is projected to rise or Home Screen: Yes remain steady.
  • Page 110 Appendix Screen Event Visual & Sound Settings Low Glucose: Default Setting: 55 - 70 mg/dL and when the • Visual Safety Symbol ( ) on glucose is projected to fall or Home Screen: Yes remain steady. • Sound & Vibration Alert : ON Editable Setting: •...
  • Page 111 Appendix Screen Event Visual & Sound Settings Urgent Low Default Setting: Glucose: ≤ 54 mg/dL • Visual Safety Symbol ( ) on Home Screen: Yes • Sound & Vibration Alert : ON Editable Setting: •...
  • Page 112 Appendix Screen Event Visual & Sound Settings 1. < 70 mg/dL regardless of the • Visual glucose check symbol projected trend direction. ) on Home Screen Home 2. Glucose rising or falling at or Screen: Yes more than 2 mg/dL per minute. •...
  • Page 113 Appendix Screen Event Visual & Sound Settings Transmitter is too far from the Default Setting: receiver (HR310) or when there • Visual message on the screen: is an obstacle (e.g. water, wall) in between transmitter and receiver • Sound & Vibration Alert : ON (HR310).
  • Page 114 Appendix Screen Event Visual & Sound Settings Receiver (HR310) battery less Default Setting: than 20%. • Visual message on the screen: • Sound & Vibration Alert : No...
  • Page 115 Appendix Screen Event Visual & Sound Settings Receiver (HR310) battery less Default Setting: than 10%. • Visual message on the screen: • Sound & Vibration Alert : Yes...
  • Page 116 Appendix Screen Event Visual & Sound Settings Transmitter battery voltage less Default Setting: than 3.5V (10%) • Visual message on the screen: • Sound & Vibration Alert : Yes...
  • Page 117 Appendix Screen Event Visual & Sound Settings 1. Receiver (HR310) scan Default Setting: distance is toofar (>1cm) • Visual message on the screen: away from the NFCtag/mark. 2. When the NFC tag/mark is • Sound & Vibration Alert: No damaged.
  • Page 118 Appendix Screen Event Visual & Sound Settings 1. Transmitter is too far from the Default Setting: receiver (HR310) or there is • Visual message on the screen: an obstacle (e.g. water, wall) in between transmitter and • Sound & Vibration Alert : No receiver (HR310).
  • Page 119 Appendix Screen Event Visual & Sound Settings When receiver (HR310) make 10 Default Setting: attempts to reconnect to sensor- • Visual message on the transmitter pair but still fails. screen: Yes • Sound & Vibration Alert : No...
  • Page 120 Appendix Screen Event Visual & Sound Settings Transmitter is not working. Default Setting: • Visual message on the screen: • Sound & Vibration Alert : Yes...
  • Page 121 Appendix Screen Event Visual & Sound Settings Transmitter detects a current Default Setting: error measured by the sensor. • Visual message on the screen: • Sound & Vibration Alert: Yes...
  • Page 122 Appendix Screen Event Visual & Sound Settings Transmitter temperature is too Default Setting: high. Temporary Issue. Move to • Visual message on the screen: a cooler environment below 45 °C and wait up to 3 hours. • Sound & Vibration Alert : Yes...
  • Page 123 Appendix Screen Event Visual & Sound Settings When sensor is to be expired in Default Setting: less than 24 hours. • Visual message on the screen: • Sound & Vibration Alert: No...
  • Page 124 Appendix Screen Event Visual & Sound Settings Your sensor session is expired. Default Setting: • Visual message on the screen: • Sound & Vibration Alert : Yes...
  • Page 125 Appendix Screen Event Visual & Sound Settings When transmitter detects a Default Setting: sensor that has been used. • Visual message on the screen: • Sound & Vibration Alert : Yes...

  • Page 127: Xv.appendix: Customer Information

    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...

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