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Rightest HM312 User Manual

Continuous glucose monitoring system
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BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Emergo Europe
Tel: +886 4 2369 2388
Prinsessegracht 20
Fax: +886 4 2261 7586
2514 AP The Hague
E-mail: info@bionime.com
The Netherlands
http://www.bionime.com
Email: EmergoVigilance@ul.com
Continuous Glucose
Monitoring System
(HM312)
User Manual
Use with a receiver (HR310)

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  • Page 1 Continuous Glucose Monitoring System (HM312) BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Taichung City 40242, Taiwan Emergo Europe User Manual Tel: +886 4 2369 2388 Prinsessegracht 20 Fax: +886 4 2261 7586 2514 AP The Hague E-mail: info@bionime.com...

  • Page 3: Table Of Contents

    I. INDICATIONS FOR USE & STATEMENT AND ADVISORY READ THIS FIRST : INDICATIONS FOR USE It is important to read the entire contents of this manual before using the RIGHTEST STATEMENT AND ADVISORY Continuous Glucose Monitoring System. The instructions, warnings, precautions, safety information as well as tips contained within II.
  • Page 4 COTENTS CONTENTS VI. SET UP YOUR RIGHTEST CGMS X. CALIBRATION (OPTIONAL) PAIRING THE SENSOR AND TRANSMITTER USING NFC CALIBRATE XI. TREATMENT DECISIONS APPLY YOUR SENSOR WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS ATTACH YOUR TRANSMITTER TREND ARROWS AND TREATMENT DECISIONS CONNECT TRANSMITTER WITH RECEIVER XII.

  • Page 5: Indications For Use & Statement And Advisory

    The RIGHTEST CGMs is also intended to autonomously interface with digitally connected devices. No MRI/CT/Diathermy: The RIGHTEST CGMs (sensor, transmitter, Receiver and/or other The RIGHTEST CGMs can be used alone or in conjunction with these digitally connected devices for receiving devices) must be removed prior to Magnetic Resonance Imaging (MRI), Computed the purpose of managing diabetes.
  • Page 6 • If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor. Children or pets without adult supervision: Don’t put any parts of the RIGHTEST CGMs in • If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor your mouth or let children and pet play with it without adult supervision.
  • Page 7 Avoid Skin Care Products or Insect Repellent: Do not apply skin care products such as DO NOT Use If You Are Pregnant, on Dialysis or Critically Ill. Do not use the RIGHTEST sunscreens, moisturizer or perfume over the sensor insertion sites. Insect repellent may CGMs if you are pregnant, on dialysis or critically ill;...
  • Page 8 Safety Information Safety Information Going Through Security Check Points. Remove all parts of the RIGHTEST CGMs before 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 exposing it to an X-ray machine.

  • Page 9: Symbol Definitions

    Symbol Definitions Symbol Definitions III. SYMBOL DEFINITIONS SYMBOL DEFINITION SYMBOL DEFINITION The following symbols apply to the RIGHTEST CGMs Protected against insertion of fingers and Keep Dry dripping water. SYMBOL DEFINITION SYMBOL DEFINITION Protected from touch by fingers and objects greater than 12.5 millimeters.
  • Page 10 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.

  • Page 11: Getting To Know Your Rightest Cgms

    The RIGHTEST CGMs is an integrated continuous glucose monitoring system (iCGM) that provides The RIGHTEST CGMs offers a number of important safety features when you use it. glucose readings, trends, and levels every minute. The system is comprised of three main These features include: components: (a) a Sensor, (b) a Bluetooth Transmitter and (c) a Receiver.

  • Page 12: The Rightest Cgms Components

    Getting to Know Your RIGHTEST CGMs Getting to Know Your RIGHTEST CGMs THE RIGHTEST CGMS COMPONENTS ACCESSORIES The RIGHTEST CGMs consists of 3 key parts: a Sensor, a Transmitter and a Receiver. These 3 parts are described below: TRANSMITTER CHARGER Inserter A USB charger is included with your transmitter.
  • Page 13 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 A complete charging cycle of the receiver takes about 4 hours. For the transmitter it takes about 2 different chargers or AC power adapters could damage the system or cause fire.
  • Page 14 Before Getting Started Before Getting Started 1. Connect the micro-USB plug of the charging cable to 2. Connect the USB plug to the USB port of the AC power the USB Type C input of the receiver. adapter supplied with your system, and connect the adapter to the power source.

  • Page 15: Battery Life Indicator On The Receiver

    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.
  • Page 16 4. Plug the charger’s USB plug into the USB port on the AC power 2. Make sure the alignment notch of the transmitter is facing the adapter supplied with the RIGHTEST CGMs, then plug the AC power charger’s transmitter compartment with the transmitter mark Alignment adapter inot the AC mains outlet (100 to 240V AC, 50/60 Hz).
  • Page 17 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 18: Set Up Your Rightest Cgms

    2. If your receiver is OFF, press and hold the [Power] button for 2 seconds to turn ON. Before setting up your RIGHTEST CGMs, make sure you have everything you need: If your receiver is ON, press the [Power] button briefly to wake up its display.
  • Page 19 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 3. Tap [Home] at the bottom of your receiver screen. 4. When the receiver prompts you to pair the sensor & Then, tap [New Monitor] to start a new monitoring transmitter, choose [Pair].
  • Page 20 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 5. Locate the NFC panel at the top of your receiver’s back cover. The center of NFC panel is 6. Tap the receiver’s NFC panel against the tag on top engraved with a mark.
  • Page 21 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed 8. Tap receiver’s NFC panel against the NFC mark as by checkmark ( √ ) on the receiver screen. on the top of transmitter until you hear a “beep” sound.
  • Page 22 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as 10. When the receiver displays “Pairing Complete”, press [Next]. 11. You will be prompted to enter your personal security code. Then press [Done].

  • Page 23: Apply Your Sensor

    Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs APPLY YOUR SENSOR The sensor is pre-loaded inside the inserter. Before applying the sensor to your skin, get familiar with the information in this section. PRECAUTIONS : Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe Overview of Sensor Inserter the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion.
  • Page 24 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs Follow these steps to apply your Senso 5. Gently move the inserter away from your insertion site. 1. Choose an insertion site on the upper arm. 6. Make sure the sensor is securely attached to your skin.

  • Page 25: Attach Your Transmitter

    DO NOT Use If Any Components Appears to be Damaged or Past Its Expiration Date. A transmitter charger supplied with the RIGHTEST CGMs. When connected to your personal damaged or cracked inserter, sensor, transmitter, or receiver could compromise the integrity computer’s USB port or USB car charger adapter, it may take much longer.
  • Page 26 Dock your spare transmitter in the transmitter charger. Store both the transmitter and its charger in 5. Press down the transmitter until it snaps into place. 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.

  • Page 27: Connect Transmitter With Receiver

    Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs CONNECT TRANSMITTER WITH RECEIVER NOTE : Make sure you go through all steps in the “Pairing WARNING : the Sensor and Transmitter using NFC” section. Use a Blood Glucose (BG) Meter. During the first 2-hour sensor warm-up period after you Make sure that you have your sensor and transmitter insert a new sensor, use a BG meter to make treatment decisions.
  • Page 28 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 3. After the system is connected, the Receiver displays NOTE : the warmup progress and remaining warmup time. If your receiver doesn’t start the search or displays a “Cannot Connect to Sensor/Transmitter Pair”...

  • Page 29: Vii. Ending A Monitoring Session

    Ending a Monitoring Session 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 .

  • Page 30: End The Monitoring Session

    Ending a Monitoring Session Ending a Monitoring Session END THE MONITORING SESSION • End the monitoring session early by selecting the upper right in “My” menu. You will see a Before you remove the sensor. Either: message warning you that the sensor has not expired yet. Press [Stop anyway] to end the •...

  • Page 31: Sensor And Transmitter Removal

    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.

  • Page 32: Viii.understand Your Glucose Readings

    Understand Your Glucose Readings Understand Your Glucose Readings VIII. UNDERSTAND YOUR GLUCOSE READINGS Overview of Receiver Home Screen Sounds & Vibration Current Time Your sensor glucose readings appear on your receiver display’s Home screen. It is important to Receiver battery level System connection status understand your readings.

  • Page 33: Glucose Information

    Understand Your Glucose Readings Understand Your Glucose Readings GLUCOSE INFORMATION Fingerstick Check and Alerts/Message 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. Glucose High/Low Alerts symbol reminds you to do a fingerstick blood glucose test before making treatment decisions.

  • Page 34: Glucose Trend Arrow And Arrow Color

    Understand Your Glucose Readings Understand Your Glucose Readings GLUCOSE TREND ARROW AND ARROW COLOR Direction What it means There are 5 different trend arrows reflecting your glucose readings and how fast they are changing. Glucose is Glucose Glucose rising Glucose Glucose falling The color (orange, amber, green, rouge and red) of the arrow helps identify the risk of hypoglycaemia steady*...

  • Page 35: Trend Graph

    Understand Your Glucose Readings Understand Your Glucose Readings TREND GRAPH Reproduced Graph Range: 0 - 500 mg/dL 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 36 Understand Your Glucose Readings Understand Your Glucose Readings ADD NOTES 2. Make sure the time is correct. 1. From the Home screen, add a note by tapping 3. Select the options (carbs, insulin, exercise) then follow the prompts. symbol in the lower right corner of the screen. 4.

  • Page 37: Access Your Notes Information

    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 Note Date/Time and is viewable in the note.

  • Page 38: High/Low Reading

    Understand Your Glucose Readings Understand Your Glucose Readings HIGH/LOW READING 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.

  • Page 39: Ix. Review Your Glucose History

    Review Your Glucose History Review Your Glucose History IX. REVIEW YOUR GLUCOSE HISTORY Glucose History Your receiver will record and analyze up to 90 days of glucose data using Ambulatory Glucose Profile Choose a report duration from here! (AGP) techniques. Make sure you have data for at least 7 - 10 days (ideally more than 14 days) to identify your glucose patterns.

  • Page 40: Calibration (Optional)

    The system does not need user calibration and you will not receive any as timely. calibration prompts from your receiver. Calibrating your RIGHTEST CGMs is optional. The calibration • When you see the symbol on your receiver allows alignment between your system readings and your meter values.
  • Page 41 Calibration (Optional) Calibration (Optional) 2. Enter the exact BG value then press [Next]. If incorrect, 3. You will see a prompt from receiver. Tap [Yes] or [No]. 4. The messages on the right side of the Calibrate screen tap the backspace key on the numeric keypad to erase display the calibration progress and whether your entry the entries then enter the correct value.

  • Page 42: Treatment Decisions

    DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not Before you start using the RIGHTEST CGMs for treatment decisions, make sure you are familiar with match what you are feeling, use your blood glucose meter; or, if needed, consult your healthcare practitioner.

  • Page 43: When Not To Use Sensor Readings When Making Treatment Decisions

    Treatment Decisions Treatment Decisions WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS When to NOT Make a Treatment Decision You must NOT make treatment decisions based on your sensor glucose reading in the following • Whenever you see this Glucose is Falling/Rising Rapidly (with upwards/ downward pointing situations: symbol on your screen,...

  • Page 44: Trend Arrows And Treatment Decisions

    The following table gives you some ideas on how you may use the arrows Glucose in Target Range (< 70 mg/dL) (> 250 mg/dL) when considering your treatment. NEVER make a treatment decision based on the RIGHTEST 45° upward (Rouge/Red Arrow •...
  • Page 45 90° downward dose upwards. Avoid “Insulin (All Arrow Colors) arrow stacking”. You will see symbol. Do a fingerstick blood glucose check with your BG meter. Do NOT treat based on your RIGHTEST CGMs.

  • Page 46: Xii. Rightest Cgms Specifications

    Specifications Specifications XII. RIGHTEST CGMS SPECIFICATIONS Inserter Size 52.0 x 57.0 x 61.3 mm (± 0.5 mm) SENSOR INSERTER SPECIFICATIONS Sterilization Sterilized by radiation Sensor Glucose Range 40 - 500 mg/dL Usage Single use (disposable) Sensor Useful Life up to 14 days...

  • Page 47: Transmitter Specifications

    Battery Run Time Up to 14 days (based on full charge) 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. Power Charging Time...

  • Page 48: Receiver Specifications

    Specifications Specifications RECEIVER SPECIFICATIONS Glucose data transfer: Bluetooth 4.0 Frequency range BLE : 2402 ~ 2480MHz Data Communication 126.1 x 68.1 x 15.2 mm with battery and silicone case Maximum RF output power of the product : 2 dBm Dimension (±1.0 mm) System pairing: NFC pairing (RFID: 13.56 MHz) Weight...

  • Page 49: Transmitter Charger Specifications

    Specifications Specifications TRANSMITTER CHARGER SPECIFICATIONS IP21 Ingress Protection Rating Protected from touch by fingers and objects greater than 12.5 Charger Channel millimeters. Protected from condensation. Indicator LED (Green/ Amber) Input Port USB Type A Weight 10 g (± 1.0) Charger Dimensions 37.3 x 26.0 x 22.5 mm (±...

  • Page 50: Xiii.certificate Statement

    Certificate Statement Certificate Statement XIII. 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 RF STATEMENT encouraged to attempt to resolve it by one or more of the following methods: This device has been evaluated to meet general RF exposure requirements.

  • Page 51: Ncc Statement

    Certificate Statement NCC STATEMENT 低功率電波輻射性電機管理辦法 「取得審驗證明之低功率射頻器材，非經核准，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。低功率射頻器材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。前述合法通信，指依電信管理法規 定作業之無線電通信。低功率射頻器材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。」...

  • Page 52: Receiver : Glucose And Signal Loss Alerts

    Appendix Appendix XIV. APPENDIX: ALARM/ALERTS Screen Event Visual & Sound Settings RECEIVER : GLUCOSE AND SIGNAL LOSS ALERTS Very High Alert Default Setting: • Visual Safety Symbol ( ) on Screen Event Visual & Sound Settings happens when glucose Home Screen: Yes. >...
  • Page 53 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Low Glucose Alert Default Setting: Low Glucose Alert Default Setting: happens when glucose is • Visual Safety Symbol ( ) on happens when glucose is • Visual Safety Symbol ( ) on between 55 - 70 mg/dL and is...
  • Page 54 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Urgent Low Alarm Default Setting: Urgent Low Alarm Default Setting: happens when glucose is • Visual Safety Symbol ( ) on happens when glucose is • Visual Safety Symbol ( ) on <...
  • Page 55 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Transmitter is too far from the Default Setting: Receiver battery less than 20%. Default Setting: receiver or when there is an • Visual message on the screen: •...
  • Page 56 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Receiver battery less than 10%. Default Setting: Transmitter battery less Default Setting: • Visual message on the screen: than 10%. • Visual message on the screen: •...
  • Page 57 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings 1. Receiver scan Default Setting: 1. Transmitter is too far from the Default Setting: distance is too far (> 1 cm) • Visual message on the screen: receiver or there is an obstacle •...
  • Page 58 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Transmitter is not working. Default Setting: The Receiver software detects Default Setting: • Visual message on the screen: a current error measured by the • Visual message on the screen: sensor.
  • Page 59 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings When sensor is to be expired in Default Setting: Transmitter temperature is too Default Setting: high. Temporary Issue. Move to • Visual message on the screen: less than 24 hours.
  • Page 60 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Your sensor session is expired. Default Setting: When the Receiver software Default Setting: • Visual message on the screen: detects a sensor that has been • Visual message on the screen: Yes.

  • Page 61: Xv. Appendix: Customer Information

    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.

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