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 101-3HM312-XXX EN Rev.
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.
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 6 6 6 7 16 18 18 PERFORMANCE FEATURES 20 SAFETY FEATURES 21 THE RIGHTEST CGMS COMPONENTS 22 ACCESSORIES 23 V.
COTENTS VI. SET UP YOUR RIGHTEST CGMS PAIRING THE SENSOR AND TRANSMITTER USING NFC APPLY YOUR SENSOR 44 ATTACH YOUR TRANSMITTER 48 START SENSOR WITH THE Receiver (HR310) VII. ENDING A MONITORING SESSION END THE MONITORING SESSION SENSOR AND TRANSMITTER REMOVAL VIII.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
15
Symbol Definitions III.
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.
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. 5. TRANSMITTER USB CHARGER: A USB charging dock for the transmitter (HM312). 6.
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.
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.
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.
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.
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).
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.
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.
Before Getting Started 1 26 1. Connect the micro-USB plug of the charging cable to the mircro-USB input of the receiver (HR310).
Before Getting Started 2 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. * * * Accessories not included.
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.
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.
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). 1 Storage Vial 1. Take out your transmitter charger from its storage vial. Hold the charger face up. Transmitter Charger 2 2. Make sure the alignment notch of the transmitter is facing the charger’s transmitter compartment with the transmitter mark facing up.
Before Getting Started 3 Lock Button 3. With the transmitter securely inside its charger compartment, turn over the charger to the back side and slide the lock button outwards. (in lock position) 4 * 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).
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 doesn’t light up, make sure you connect to a power source with output rating of 500mA or higher.
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 • 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 unique code established on the tag attached on the sensor inserter package.
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.
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.
Set Up Your RIGHTEST CGMs 4. When the receiver (HR310) prompts you to pair the sensor & transmitter, choose [Pair].
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.
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.
Set Up Your RIGHTEST CGMs 7. Once connected, pairing confirmation is displayed as by checkmark ( √ ) on the receiver (HR310) screen.
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.
Set Up Your RIGHTEST CGMs 9. Once connected, pairing confirmation is displayed as by checkmark ( √ ) the screen.
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].
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.
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.
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.
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.
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.
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 computer’s USB port or USB car charger adapter, it may take much longer.
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.
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.
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. Modification of the System is Not Allowed: Do not modify or tamper with any components or accessories of the RIGHTEST CGMs.
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.
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. 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].
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. 2 2. The receiver (HR310) will automatically start searching for your sensor-transmitter pair. Keep your receiver (HR310) close to you.
Set Up Your RIGHTEST CGMs 3. Wait for successful connection confirmation with a graphic.
Set Up Your RIGHTEST CGMs 4. If you want to add a data security number press 4 Learn more. If you do not want to add a security number, then proceed to step 7.
Set Up Your RIGHTEST CGMs 5. Press [Add Now] to configure your 4-digit security code.
Set Up Your RIGHTEST CGMs 6. You will be prompted to enter your personal security code. Then press [Done].
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.
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.
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 .
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.
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.
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.
Ending a Monitoring Session 1 3 4 67
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. etc.) is displayed on your receiver (HR310)’s Home screen. It is important to understand these indicators before use.
Understand Your Glucose Readings Overview of Receiver (HR310) Home Screen Sounds & Vibration System connection status Current Time Receiver (HR310) battery level Days until sensor expiration Glucose High/Low Alerts Trend Arrow Glucose Reading Check Blood Glucose When you see this symbol, you must check your blood glucose value with a meter before making any treatment decisions.
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.
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.
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.
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.
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.
Understand Your Glucose Readings Reproduced Graph Range: 0 - 500 mg/dL Most Recent Reading High Target Low Target Note logs 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.
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.
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.
Understand Your Glucose Readings Note Date/Time Glucose reading at selected point in time Events 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.
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.
Review Your Glucose History 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.
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. Sensor readings may be less accurate and may not reflect your current glucose levels.
Calibration (Optional) 2. Enter the exact BG value then press [Next]. If incorrect, 2 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.
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.
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.
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 won’t get any sensor readings, alarm/alerts until your system begins to transmit data.
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.
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). Low Glucose or Urgent Low Message: Sensor glucose readings may not accurately reflect your blood glucose.
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) You will see symbol.
Treatment Decisions Trend Arrow Treatment Decision Low Glucose (<70 mg/dL) 45° upward arrow Glucose in Target Range (Rouge/Red Arrow (No Trend Arrow) Colors) You will see • If you are about to eat, symbol. take insulin to cover your Do a fingerstick meal. Consider blood glucose increasing your dose a check with your little since your glucose BG meter. Do NOT is rising. treat based on your • If you’ve recently taken RIGHTEST CGMs.
Treatment Decisions Trend Arrow Trend Arrow Low Glucose (<70 mg/dL) Horizontal arrow 94 Glucose in Target Range High Glucose (>250 mg/dL) (Rouge/Red Arrow • If you are about to eat, (Orange Arrow Color) Colors) You will take insulin to cover your • If you are about to eat, take see symbol. meal. insulin to cover your meal. Do a fingerstick • If you’ve recently taken Consider increase your dose a blood glucose check insulin or are about to little since your glucose is high. with your BG meter.
Treatment Decisions Trend Arrow Trend Arrow Low Glucose (<70 mg/dL) Glucose in Target Range High Glucose (>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 see symbol. to cover your meal. to cover your meal. Consider taking Do a fingerstick Consider taking a a lower dose since your glucose blood glucose check lower dose since is falling. with your BG meter.
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: 5°C - 45°C (41°F - 113°F) Relative humidity: 10% - 90% Sensor Ingress Protection Rating (when installed with a transmitter) IP47 Protected from tools and small wires greater than 1 millimeter.
Specifications Inserter Size 51.8 mm*57.0 mm*61.3 mm (+/- 0.
Specifications Transmitter Specifications Model Transmitter Size HM312 HM310 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.
Specifications Model Memory Storage HM312 14 days of glucose data (glucose readings stored every 5 minutes) HM310 14 days of glucose data (glucose readings stored every 5 minutes) Ingress Protection Rating (when attached to Sensor) 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.
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.
Specifications Ingress Protection Rating IP22 Protection against insertion of fingers and objects greater than 12.5 millimeters. Protection against dripping water when tilted up to 15°. Power Supply Input: 100 - 240V ~ 50 - 60Hz, 0.2A Output: DC5.0V, 1.0A, 5.0W Operating temperature: 0° ~ 45° Compatible AC Power Adapter Output: DC5.0V, 0.01-3.00 A, 15W Model: UES18LCPU-XXXYYYSPA Manufacturer: Dongguan Shilong Fuhua Electronic Co., Ltd.
Specifications Transmitter Charger Specifications (for Transmitter model HM312) Charger Channel 1 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.
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.
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.
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.
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.
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.
Appendix XIV. APPENDIX: ALARM/ALERTS Receiver (HR310): GLUCOSE AND SIGNAL LOSS ALERTS Screen 108 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.
Appendix Screen Event Low Glucose: 55 - 70 mg/dL and when the glucose is projected to fall 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.
Appendix Screen 110 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 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.
Appendix Screen 112 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).
Appendix Screen Event Receiver (HR310) battery less than 20%.
Appendix Screen 114 Event Receiver (HR310) battery less than 10%.
Appendix Screen Event Transmitter battery voltage less than 3.
Appendix Screen 116 Event 1. Receiver (HR310) scan distance is toofar (>1cm) away from the NFCtag/mark. 2. When the NFC tag/mark is damaged.
Appendix Screen 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.
Appendix Screen 118 Event When receiver (HR310) make 10 attempts to reconnect to sensortransmitter pair but still fails.
Appendix Screen Event Transmitter is not working.
Appendix Screen 120 Event Transmitter detects a current error measured by the sensor.
Appendix Screen Event Transmitter temperature is too high. Temporary Issue. Move to a cooler environment below 45°C and wait up to 3 hours.
Appendix Screen 122 Event When sensor is to be expired in less than 24 hours.
Appendix Screen Event Your sensor session is expired.
Appendix Screen 124 Event When transmitter detects a sensor that has been used.
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.
