BIONIME RIGHTEST HR310 User manual

101-3HM312-XXX EN
User Manual
Rev. Date: 2020-06
Continuous Glucose
Monitoring System
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
http://www.bionime.com
E-mail: [email protected]om Use with a receiver
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
E-mail: [email protected]
0197

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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.

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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. BEFORE GETTING STARTED
CHARGING BASICS
CHARGING THE Receiver (HR310)
BATTERY LIFE INDICATOR ON THE Receiver (HR310)
CHARGING THE TRANSMITTER
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COTENTS
VI. SET UP YOUR RIGHTEST CGMS
PAIRING THE SENSOR AND TRANSMITTER USING NFC
APPLY YOUR SENSOR
ATTACH YOUR TRANSMITTER
START SENSOR WITH THE Receiver (HR310)
VII. ENDING A MONITORING SESSION
END THE MONITORING SESSION
SENSOR AND TRANSMITTER REMOVAL
VIII.UNDERSTAND YOUR GLUCOSE READINGS
HOME SCREEN INDICATOR AND DISPLAYS OVERVIEW
GLUCOSE INFORMATION
GLUCOSE TREND ARROW AND ARROW COLOR
TREND GRAPH
ADD NOTES
ACCESS YOUR NOTES INFORMATION
HIGH/LOW READING
IX. REVIEW YOUR GLUCOSE HISTORY
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X. CALIBRATION (OPTIONAL)
CALIBRATE
XI. TREATMENT DECISIONS
WHEN NOT TO USE SENSOR READINGS WHEN MAKING TREATMENT DECISIONS
TREND ARROWS AND TREATMENT DECISIONS
XII. RIGHTEST CONTINUOUS GLUCOSE MONITORING SYSTEM SPECIFICATIONS
SENSOR INSERTER SPECIFICATIONS
TRANSMITTER SPECIFICATIONS
Receiver (HR310) SPECIFICATIONS
TRANSMITTER CHARGER SPECIFICATIONS
XIII.CERTIFICATE STATEMENT
RF STATEMENT
FCC STATEMENT
NCC STATEMENT
XIV.APPENDIX: ALARM/ALERTS
RECEIVER (HR310): GLUCOSE AND SIGNAL LOSS ALERTS
RECEIVER (HR310): SYSTEM ALERTS AND NOTIFICATIONS (WITH NO EDITABLE SETTINGS)
XV.APPENDIX: CUSTOMER INFORMATION
CUSTOMER SERVICE
WARRANTY
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CONTENTS
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Indications for Use & Statement and Advisory
I. INDICATIONS FOR USE & STATEMENT AND ADVISORY
INDICATIONS FOR USE
The RIGHTEST Continuous Glucose Monitoring System (the RIGHTEST CGMs) is indicated for
detecting glycaemia trends and for the management of diabetes in persons age 4 and older. For the
younger user, the personal representative of a minor shall supervise their use with the RIGHTEST
CGMs. It's an applied part and it is designed to replace blood glucose testing for diabetes treatment
decisions. Interpretation of the RIGHTEST CGMs results shall be based on the glucose trends
and several sequential readings over time. It also aids detecting episodes of hyperglycemia and
hypoglycemia, facilitating both acute and long-term therapy adjustments.
The RIGHTEST CGMs is also intended to autonomously interface with digitally connected devices.
The RIGHTEST CGMs can be used alone or in conjunction with these digitally connected devices for
the purpose of managing diabetes.
STATEMENT AND ADVISORY
This manual is designed to instruct all personnel responsible for the proper use and care of the
RIGHTEST CGMs. All users are urged to carefully read this manual before using the system.

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Safety Information
II. SAFETY INFORMATION
The following is a summary of safety information which must be observed before using the
RIGHTEST Continuous Glucose Monitoring System (the RIGHTEST CGMs). WARNING indicates
potential danger to user. PRECAUTION indicates potential injury to the user or damage to the
system. To minimize risks, read the following safety information before using the system. Improper
use and maintenance may damage the system resulting in failure or user injury. It is important to
understand that the safety information is not exhaustive. It is meant to keep the user safe while using
the system.
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.
WHEN NOT TO USE (CONTRAINDICATIONS) :
No MRI/CT/Diathermy: The RIGHTEST CGMs (sensor, transmitter, Receiver (HR310) and/
or other receiving devices) must be removed prior to Magnetic Resonance Imaging (MRI),
Computed Tomography (CT), or high frequency electrical heat (diathermy) treatment.

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Safety Information
WARNINGS :
Read This Manual First. Failure to operate the system according to the guidelines and
safeguards specified in this manual could result in a hazardous condition.
DO NOT Ignore Low/High Blood Glucose Symptoms. If your glucose readings do not
match what you are feeling, use your blood glucose meter; or, if needed, consult your
healthcare practitioner.
Use a Blood Glucose (BG) Meter To Make Treatment Decisions Under The Following
Conditions:
• During the first 2-hour warmup period when you start a new sensor. You won’t get any
sensor readings, alarm/alerts until your system begins to transmit data.
• If you suspect that your sensor readings may be inaccurate for any reason.
• If your sensor readings do not match what you are feeling.
• If you are experiencing symptoms that may be due to low or high blood glucose.
• If your sensor readings do not include your current glucose concentration or a glucose trend
arrow.
• If you wish to confirm hypoglycemia or impending hypoglycemia as reported by the sensor.
• If you are experiencing rapid glucose changes (more than 2 mg/dL per minute), the sensor
readings displayed may be less accurate and not as timely.
• When you see the symbol on your receiver (HR310) display, you must check your BG
value with a BG meter before making any treatment decisions. Sensor readings may be less
accurate and may not reflect your current glucose levels.

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Safety Information
Not Getting Urgent Alarm/Alert. The RIGHTEST CGMs Receiver (HR310) lets you know
when your sensor readings drop to or below 54 mg/dL; or when your sensor reading is below
70 mg/dL and continuously falling for the following 2 consecutive readings (or 10 minutes)
regardless your alarm/alert settings. There are no alarm/alerts in the following situations.
• When either your receiver (HR310) or transmitter battery is dead.
• When your receiver (HR310) is turned off.
• When there is a system error (e.g. no glucose readings, sensor error, signal loss etc.) or
system damage.
• During the 2-hour sensor warm-up period.
•If your sensor readings do not match what you are feeling.
• When the receiver (HR310) is out of range (6 meter/20 feet) from your transmitter; or
obstacles (metal, wall or water etc.) are between them them.
Modification of the System is Not Allowed: Do not modify or tamper with any components
or accessories of the RIGHTEST CGMs. Otherwise, you could damage the integrity of the
system and put yourself at risk especially when you have a severe low or high glucose event.
Children or pets without adult supervision: Don’t put any parts of the RIGHTEST CGMs in
your mouth or let children and pet play with it without adult supervision.
Choking Hazard: The RIGHTEST CGMs contains small components that may be dangerous
if swallowed.
• INTERNALLY POWERED ME EQUIPMENT. Not Suitable for use in an OXYGEN RICH
ENVIRONMENT

PRECAUTIONS :
DO NOT Use If You Are Pregnant, on Dialysis or Critically Ill. Do not use the RIGHTEST
CGMs if you are pregnant, on dialysis or critically ill; or on users with other implanted medical
devices (e.g. a pacemaker). The system has not been evaluated in these populations.
DO NOT Use the System on Skin With Extensive Skin Changes or Diseases. Do not use
the RIGHTEST CGMs on persons who have extensive psoriasis, extensive eczema, extensive
scarring, or extensive tattoos; or on skin insertion sites that are dermatitis herpetiformis
infected, irritated, burned or cut.
DO NOT Use If Any Components Appear to be Damaged or Past its Expiration Date.
A damaged or cracked sensor inserter, transmitter or receiver (HR310) could compromise
the integrity of the system or contribute to infection risk. Do not use if your sensor has past its
expiration date. The sensor expiration date is written in YYYY-MM-DD (Year-Month-Day) format
on your sensor inserter package.
Scan the NFC Tags First before Connecting to the System: Each sensor has its unique
code established on the tag attached on the sensor inserter package. The transmitter’s
code is located right beneath its top plastic cover where you see a mark. Every time you
begin the use of a new sensor, scan both codes to ensure successful system connections.
The system will not start if you fail to scan the codes.
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Safety Information

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Safety Information
Calibration Safety: Calibration is not required if users scan sensor & transmitter codes. If
necessary, calibrate your system for accurate readings. Take additional precautions when you
enter your blood glucose value. Entering incorrect blood glucose values for calibration can
result in inaccurate glucose readings, which may result in you missing a high or low glucose
event.
Clean Before Use: Clean your hands before sensor insertion. To minimize infection risk, wipe
the insertion site with an alcohol wipe, and ensure the site is dry prior to sensor insertion. This
helps the sensor stay attached to your body.
DO NOT Place the Sensor on Any Area of the Body other than the Upper Arm or
Abdomen: Placing the sensor on other areas of the body has not been tested and the risks
are unknown.
Select an Appropriate Sensor Insertion Site: Do NOT place the sensor on skin that is
painful to touch, raised (higher than surrounding skin), crusting or bleeding; or on areas with
scars, tattoos or moles. Select a skin area that stays flat during normal daily activities. Choose
a site that is greater than 2.5 cm (1 inch) away from any insulin injection sites.
Change the Sensor Insertion Site for the Next Sensor Insertion: Placing the next sensor
on the same spot will increase skin irritation or redness and could potentially lead to scabs.
Excessive Sweat or Body Movement Can Cause Your Sensor to Loosen: Remove and
replace your sensor if it starts to loosen.

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Safety Information
PRECAUTIONS :
Skin Irritation Reaction Caused by Sensor Adhesive: Some individuals may be sensitive to
the medical adhesive that keeps the sensor attached to the skin. If you develop a rash around
or under your sensor, remove the sensor and stop using the RIGHTEST CGMs. If needed,
consult your health care professional.
Avoid Skin Care Products or Insect Repellent: Do not apply skin care products such as
sunscreens, moisturizer or perfume over the sensor insertion sites. Insect repellent may
damage the plastic used in the RIGHTEST CGMs. Failure to comply may lead to inaccurate
system performance.
Store the Sensor in a Dry Room: Store your sensor at a temperature of 5°C to 30°C
(41°F to 86°F) and 10%~90% non-condensing humidity. You can also store the sensor in the
refrigerator at 5°C to 30°C (41°F to 86°F). Do NOT freeze the sensor.
DO NOT Reuse Your Inserter, Sensor, and Single-use Transmitter (HM310): The inserter
is pre-loaded with a sensor. The entire sensor inserter package is sterilized and designed for
single use. HM310 transmitters are designed for single-use and are not rechargeable.
All RIGHTEST CGMs components are not suitable for re-sterilization. Reuse of these
components may result in no glucose readings and infections.
Discard Sensor Inserter in an appropriate puncture-proof or biohazard container, for
safety and to prevent cross-contamination.

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Safety Information
DO NOT Share Your Re-chargeable Transmitter (HM312): The RIGHTEST CGMs’ HM312
transmitter is rechargeable and reusable. Never share your transmitter with others. The
system is a prescription-only medical device and is meant for your use only. If used by other
persons, the glucose readings, report, alerts/alarms, etc., may be wrong.
Use the Charger as Directed: Use only the AC power adapter, USB cable and USB charger
provided with the RIGHTEST CGMs when charging your receiver (HR310) and transmitter.
Using different chargers or AC power adapters could damage the system or cause fire. Use
USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation
risk.
Do NOT Use If the Receiver (HR310) is Damaged, or If It Could Fall into Water.
The receiver (HR310) and accessories are enclosed without protection from the ingress of
water. Do not submerge these components in water. If the receiver (HR310) has fallen into
water, do not touch it until you unplug it from any electrical outlet. Touching the receiver (HR310)
while it is wet or damaged could result in electric shock or no glucose results.
Test Your Receiver (HR310) Regularly. Test your receiver (HR310)’s speaker and vibration
functions regularly. If you are in any doubt, contact a manufacturer authorized dealer for
technical support.
Interfering Substance Risks. Acetaminophen may falsely raise sensor readings to higher
than they really are.

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Safety Information
PRECAUTIONS :
Keep Your Receiver (HR310) Close. Be sure your receiver (HR310) is close to your
transmitter and in the same room. The maximum transmission distance is 6 meters (20 feet)
with no obstructions (e.g. wall, metal, glass or water) in between. Obstructions or longer
distances may cause Bluetooth signal loss and you will not receive important alerts/alarms.
Plug in to Charge.
• Be sure to fully charge your transmitter (HM312) every time you start with a new sensor.
When plugged into an adapter that is connected to a standard household electrical outlet
(100 to 240 VAC, 50/60Hz), the transmitter battery requires approximately 2 hours to fully
charge. When connected to your personal computer’s USB port or USB car charger
adapter, it may take a longer time.
• To best protect yourself from not getting the alarm/alerts due to a depleted battery, plug in
your receiver (HR310) to its charger at the end of the day and charge it up overnight.
Going Through Security Check Points. Remove all parts of the RIGHTEST CGMs before
exposing it to an X-ray machine. The effect of X-rays on the system has not been evaluated.
Adequate Brightness while reading: If you have difficulty reading your receiver (HR310) in
bright sunlight, you may need to seek a shady location.

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Symbol Denitions
III. SYMBOL DEFINITIONS
The following symbols apply to the RIGHTEST Continuous Glucose Monitoring System
SYMBOL DEFINITION SYMBOL DEFINITION
Date of Manufacture Do not use if package is damaged
Manufacturer Biological risks
Authorized representative in
the European Community
For single use only
Batch/Lot Number Type BF applied part device
Expiry date Direct current
Temperature limitation Alternating current
Humidity limitation Medical Device
Method of sterilization using
irradiation
Protected from tools and small wires greater than 1 millimeter.
Protected from immersion between 15 centimeters and 1 meter
in depth.
MD

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Symbol Denitions
SYMBOL DEFINITION SYMBOL DEFINITION
Protected against insertion of fingers and dripping water. Keep Dry
Protected from touch by fingers and objects greater than
12 millimeters. Protected from condensation.
MR Unsafe
Serial Number Prescription Required
CE Mark with Notified Body Number Refer to Instruction Manual/Booklet
Bluetooth Electrical Equipment Designed Primarily
for Indoor Use (Chargers Only)
Class II Equipment Warning/Precaution
Input Operating Instructions; consult manual
for further instructions
Keep away from heat Near-field communication (NFC) scan
area
Importer

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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. STORAGE VIAL: Storage for the transmitter and transmitter USB charger to keep them dry.

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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.