BIONIME RIGHTEST HR310 Manuale utente

101-3HM312-XXX

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

E-mail: [email protected]om Use with a receiver

BIONIME GmbH

Tramstrasse 16

9442 Berneck

Switzerland

E-mail: [email protected]

0197

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

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

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

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

CONTENTS

100

102

104

106

108

126

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.

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.

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.

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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