BIONIME RIGHTEST HR310 Manuale utente
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: +886 4 2369 2388
Fax: +886 4 2261 7586
http://www.bionime.com
BIONIME GmbH
Tramstrasse 16
9442 Berneck
Switzerland
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
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