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BIONIME RIGHTEST User Manual

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

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Summary of Contents for BIONIME RIGHTEST

  • Page 1 Continuous Glucose Monitoring System BIONIME CORPORATION No. 100, Sec. 2, Daqing St., South Dist., Emergo Europe Taichung City 40242, Taiwan User Manual Tel: +886 4 2369 2388 Prinsessegracht 20 Fax: +886 4 2261 7586 2514 AP The Hague Email: 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 this manual are intended to help ensure proper II.
  • Page 4 COTENTS CONTENTS VI. SET UP YOUR RIGHTEST CGMS XI. TREATMENT DECISIONS PAIRING THE SENSOR AND TRANSMITTER USING NFC WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS APPLY YOUR SENSOR TREND ARROWS AND TREATMENT DECISIONS ATTACH YOUR TRANSMITTER XII. RIGHTEST CGMS SPECIFICATIONS...

  • Page 5: Indications For Use & Statement And Advisory

    WHEN NOT TO USE: 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 STATEMENT AND ADVISORY implanted medical devices (e.g.

  • Page 6: Safety Information

    BG meter before making any treatment decisions. Sensor readings may be less accurate Children or pets without adult supervision: Don’t put any parts of the RIGHTEST CGMs in and may not reflect your current glucose levels. your mouth or let children and pet play with it without adult supervision.
  • Page 7 If you develop a rash around result in no glucose readings and infections. or under your sensor, remove the sensor and stop using the RIGHTEST CGMs. If needed, Use as Directed: Use only the AC power adapter, USB cable and USB charger provided with consult your healthcare professional.
  • Page 8 • Glucagon™ emergency kit. the security personnel of the presence of the RIGHTEST CGMs and ask for pat-downs, visual inspection, and walk through metal detectors. You must comply any requests by Trouble Shooting If any situation not mentioned in this user manual happens, please contact your healthcare professional or Customer Service.

  • Page 9: Symbol Definitions

    Symbol Definitions Symbol Definitions III. SYMBOL DEFINITIONS SYMBOL DEFINITION SYMBOL DEFINITION The following symbols apply to the RIGHTEST CGMs Protected from touch by fingers and objects greater than 12.5 millimeters. Protected from dripping water Keep Dry SYMBOL DEFINITION SYMBOL DEFINITION when tilted at 15°.
  • 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: Before Getting Started

    Before Getting Started Before Getting Started V. BEFORE GETTING STARTED CHARGING THE RECEIVER WARNINGS : CHARGING BASICS Not Getting Urgent Alarm/Alert. There are no alarm/alerts, when your receiver is turned off or Before using the system for the first time, charge the receiver for a complete charging cycle without its battery is dead.
  • Page 14 Before Getting Started Before Getting Started 1. Connect the USB Type C Plug of the charging cable to 2. Connect the USB plug to the USB port of the the USB Type C input of the receiver. AC power adapter supplied with your system, and connect the adapter to the power source.

  • Page 15: Battery Life Indicator On The Receiver

    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.
  • 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 transmitter metal 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 [New Monitor] to start a new monitoring session. 4. When the receiver prompts you to pair the sensor & 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 of the sensor inserter package until you engraved with a mark.
  • Page 21 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed as by checkmark ( √ ) on the receiver screen. 8. Tap receiver’s NFC panel against the NFC mark on the top of transmitter until you hear a “beep”...
  • Page 22 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as by checkmark ( √ ) the screen. 10. When the receiver displays “Ready to Start”, check whether the serial number of the sensor and the transmitter is the same as which are labeled on the package.

  • 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 sensor 4. Place the inserter over the site and push down firmly to insert the sensor. Stay for 10 seconds to 1. Wash your hands and wipe them with clean cloth thoroughly.
  • Page 25 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 5. Gently move the inserter away from your insertion site. Make sure the sensor is securely attached PRECAUTION : to your skin. Watch for bruising or bleeding at the insertion site (under, around, or on top of the sensor and 6.

  • Page 26: Attach Your Transmitter

    ATTACH YOUR TRANSMITTER Overview of the Transmitter PRECAUTIONS : 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 Transmitter: prescription-only medical device and is meant for your use only. If used by other persons, the •...
  • Page 27 Dock your spare transmitter in the transmitter charger. Store both the transmitter and its charger in 4. Align both notches on the sensor base and transmitter. the storage vial provided with your RIGHTEST CGMs. Before attaching the transmitter, make sure it 5. Press down the transmitter until it snaps into place.

  • Page 28: Connect Transmitter With Receiver

    (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. DO NOT Share Your Receiver. The RIGHTEST CGMs' receiver is designed for self-use of a single patient. Never share your receiver with others. The system is a prescription- only medical device and is meant for your use only.
  • Page 29 Set Up Your RIGHTEST CGMs Set Up Your RIGHTEST CGMs 3. After the system is connected, the Receiver displays the warmup progress and remaining warmup NOTE : time. When the warmup is completed, "Warmup" disappears from your display. If your receiver doesn’t start the search or displays a “Cannot Connect to Sensor/Transmitter Pair”...

  • Page 30: 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 31: End The Monitoring Session

    Ending a Monitoring Session Ending a Monitoring Session END THE MONITORING SESSION If you intend to or be asked to end the monitoring session before receiving “Session is Ended” The monitoring session ends automatically when the sensor reaches its life of 14-day and the sensor notification, you can do that by selecting the upper right in “My”...

  • Page 32: Sensor And Transmitter Removal

    Ending a Monitoring Session Ending a Monitoring Session SENSOR AND TRANSMITTER REMOVAL Do not remove your transmitter until your sensor session is over. 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 in one motion. 2.

  • Page 33: 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 understand your readings. Receiver battery level HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW Your glucose information (e.g.

  • 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: Add Notes

    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 the symbol in the lower right corner of the 3. Select the options (carbs, insulin, exercise) then follow the prompts. screen 4.

  • Page 36: 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 and is viewable in the note.

  • Page 37: 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 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 38: Calibration And Wi-Fi Connection (Optional)

    The system does not need user calibration and you will not receive any 1. From the Calibrate screen, tap [Calibrate Now]. calibration prompts from your receiver. Calibrating your RIGHTEST CGMs is optional. The calibration allows alignment between your system readings and your meter values.

  • Page 39: Wi-Fi Connection

    Calibration and Wi-Fi Connection(Optional) Calibration and Wi-Fi Connection(Optional) 2. Enter the exact BG value then press [Next]. If incorrect, tap the backspace key on the numeric Wi-Fi CONNECTION (for HR321) keypad to erase the entries then enter the correct value. Receiver could access to internet via Wi-Fi network.

  • Page 40: 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 41: 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 situations: 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.

  • Page 42: 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 43 If you’ve recently taken insulin or Do NOT treat based exercise, do nothing • If you’ve recently taken insulin on your RIGHTEST falling. are about to exercise, do nothing on your RIGHTEST and check your sensor or are about to exercise, CGMs.

  • Page 44: 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 45: 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 46: Receiver Specifications

    Output: 5V DC, 1A (5.0W) Class II Alarm Output Sound Speaker; Vibration Only update authorized by Bionime Corporation is recommended. Any update from unofficial Storage Transportation & Operating Temperature: 0°C - 45°C (32°F - 113°F) channel may bring security risk.

  • Page 47: 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 48: 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 49: 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 50: Receiver : Glucose And Signal Loss Alerts

    Appendix Appendix XIV. APPENDIX: ALARM/ALERTS Screen Event Visual & Sound Settings RECEIVER : GLUCOSE AND SIGNAL LOSS ALERTS Low Glucose Alert Default Setting: Screen Event Visual & Sound Settings happens when glucose is • Visual Safety Symbol ( ) on between 55 - 70 mg/dL and is Home Screen: Yes.
  • Page 51 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Urgent Low Alarm Default Setting: Transmitter is too far from the Default Setting: happens when glucose is • Visual Safety Symbol ( ) on receiver or when there is an •...
  • Page 52 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings Receiver battery less than 20%. Default Setting: Transmitter is not working. Default Setting: • Visual message on the screen: • Visual message on the screen: Yes. •...
  • Page 53 Appendix Appendix Screen Event Visual & Sound Settings Screen Event Visual & Sound Settings The system detects a current Default Setting: When sensor is to be expired in Default Setting: error measured by the sensor. • Visual message on the screen: less than 24 hours.

  • Page 54: Xv. Appendix: Customer Information

    - Vibrates 1 time and beeps 1 time at the alarm volume If you are in the serious incidents caused by the RIGHTEST product, please call local emergency following the user settings. service for help. Please feel free to report your incident to us and the local competent authority.
  • Page 55 Manufacturer’s declaration-electromagnetic emissions Manufacturer’s declaration-electromagnetic immunity The Receiver(HR321), Receiver(HR320) is intended for use in the electromagnetic environment The Receiver(HR321), Receiver(HR320) is intended for use in the electromagnetic environment (for (for home healthcare) specified below. The customer or the user of the Receiver(HR321), home healthcare) specified below.
  • Page 56 Immunity test IEC 60601 Compliance level Electromagnetic environment- Manufacturer’s declaration-electromagnetic immunity test level guidance (for home healthcare The Receiver(HR321), Receiver(HR320) is intended for use in the electromagnetic environment (for environment) home healthcare) specified below. Voltage Voltage dips: Voltage dips: Mains power quality should be that of a The customer or the user of the Receiver(HR321), Receiver(HR320) should assure that it is used in Dips, short 0 % UT;...
  • Page 57 Immunity test IEC 60601 test Compliance level Electromagnetic environment-guidance Recommended separation distance between level (for home healthcare environment) portable and mobile RF communications equipment and the Receiver(HR321), Receiver(HR320) The Receiver(HR321), Receiver(HR320) is intended for use in an electromagnetic environment (for Radiated RF 10 V/m 10 V/m...
  • Page 58 For transmitters rated at a maximum output power not listed above, the recommended separation Manufacturer’s declaration-electromagnetic immunity distance d in meters (m) can be estimated using the equation applicable to the frequency of the Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to equipment the transmitter manufacturer.
  • Page 59 Test Band a) Service a) Modulation Maximum Distance IMMUNITY Compliance Test Band a) Service a) Modulation Maximum Distance IMMUNITY Compliance frequency (MHz) power TEST LEVEL frequency (MHz) power TEST LEVEL (MHz) LEVEL (V/m) (MHz) LEVEL (V/m) (V/m) (for home (V/m) (for home healthcare) healthcare)

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