Rightest HM312 User manual

101-3HM312-010 EN
User Manual
Rev. Date: 2021-01
Continuous Glucose
Monitoring System
(HM312)
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
E-mail: [email protected]om
http://www.bionime.com Use with a receiver (HR310)
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Email: EmergoVig[email protected]

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CONTENTS
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.
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
BATTERY LIFE INDICATOR ON THE RECEIVER
CHARGING TRANSMITTER
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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 CGMS SPECIFICATIONS
SENSOR INSERTER SPECIFICATIONS
TRANSMITTER SPECIFICATIONS
RECEIVER SPECIFICATIONS
TRANSMITTER CHARGER SPECIFICATIONS
XIII.CERTIFICATE STATEMENT
RF STATEMENT
FCC STATEMENT
NCC STATEMENT
XIV.APPENDIX: ALARM/ALERTS
RECEIVER : GLUCOSE AND SIGNAL LOSS ALERTS
XV. APPENDIX: CUSTOMER INFORMATION
CUSTOMER SERVICE
WARRANTY
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CONTENTS
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COTENTS
VI. SET UP YOUR RIGHTEST CGMS
PAIRING THE SENSOR AND TRANSMITTER USING NFC
APPLY YOUR SENSOR
ATTACH YOUR TRANSMITTER
CONNECT TRANSMITTER WITH RECEIVER
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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Safety Information
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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 (hereafter referred to as the "RIGHTEST
CGMs") is indicated for detecting glycaemia trends and for the management of diabetes in persons
age 18 to 80. 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.
II. SAFETY INFORMATION
The following is a summary of safety information which must be observed before using 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 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
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Safety Information
Not Getting Urgent Alarm/Alert. The RIGHTEST CGMs Receiver 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 reading(s) regardless your alarm/alert settings. There
are no alarm/alerts in the following situations.
• When either your receiver or transmitter battery is dead.
• When your receiver 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 is out of range (6 meter/20 feet) from your transmitter; or obstacles (metal,
wall or water etc.) are between 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
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 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.

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.
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.
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.
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Safety Information
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Safety Information
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, and Sensor: The inserter is pre-loaded with a sensor. The
entire sensor inserter package is sterilized and designed for single use.
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.
Check sensor package. Do not use the sensor if its sterile package has been damaged or
open because it may cause infection.
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 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.

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Safety Information
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Safety Information
Do NOT Use If the Receiver is Damaged, or If It Could Fall into Water.
The receiver and accessories are enclosed without protection from the ingress of water. Do
not submerge these components in water. If the receiver has fallen into water, do not touch it
until you unplug it from any electrical outlet. Touching the receiver while it is wet or damaged
could result in electric shock or no glucose results.
Test Your Receiver Regularly. Test your receiver’s speaker and vibration functions regularly. If
you are in any doubt, contact a manufacturer authorized dealer for technical support.
Keep Your Receiver Close. Be sure your receiver 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 every time you start with a new sensor. When
plugged into an adapter that is connected to a standard household electrical outlet (100 to
240V AC, 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 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 in bright
sunlight, you may need to seek a shady location.

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Symbol Definitions
III. SYMBOL DEFINITIONS
The following symbols apply to the RIGHTEST CGMs
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.
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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 12.5 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
MD

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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.
3. RECEIVER : Blood glucose information display.
4. POWER SUPPLY: AC power adapter & USB cable.
5. TRANSMITTER CHARGER : A USB charging dock for the transmitter.
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

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Getting to Know Your RIGHTEST CGMs
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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 minute. The system is comprised of three main
components: (a) a Sensor, (b) a Bluetooth Transmitter and (c) a Receiver. The sensor is pre-loaded
inside an Inserter. The sensor is inserted under your skin and measures your interstitial glucose level
test glucose. The transmitter wirelessly sends data to the receiver.
The receiver displays glucose values and alerts users to hypoglycemia and hyperglycemia.
The RIGHTEST CGMs user-friendly features and benefits include:
• Ergonomic design of sensor inserter allows users to insert the sensor safely with just one hand.
• Easy-to-read visual glucose values and trends.
• Transmitter’s powerful storage holds 14 days of glucose readings with zero data loss.
• Getting visual and audible alerts to hypoglycemia and hyperglycemia.
• Lightweight sensor and transmitter for maximum comfort.
SAFETY FEATURES
The RIGHTEST CGMs offers a number of important safety features when you use it.
These features include:
• Receiver’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 alerts you.
• Receiver warns you if your glucose level falls below 54 mg/dL; or when your sensor reading is
below 70 mg/dL and continuously falling for the following reading(s).
• Urgent alert/alarm settings at 54 mg/dL or below; or below 70 mg/dL and continuously falling for
the following reading(s) cannot be changed or turned off.
• Receiver notifies you when a sensor has failed, expired or when there are system errors.

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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.
These 3 parts are described below:
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Getting to Know Your RIGHTEST CGMs
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.
TRANSMITTER
The transmitter sends your glucose data from the sensor to the Receiver.
The transmitter is equipped with a rechargeable battery.
RECEIVER
The receiver displays glucose values and alerts you to hypo/
hyperglycemia.
Inserter
Sensor
Inside
ACCESSORIES
TRANSMITTER CHARGER
A USB charger is included with your 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. It connects to an AC mains
outlet (100 to 240V AC, 50/60 Hz).

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Before Getting Started
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Before Getting Started
V. BEFORE GETTING STARTED
CHARGING BASICS
Before using the system for the first time, charge the receiver for a complete charging cycle without
interruption. A transmitter charger is supplied along with your transmitter package. Rechargeable
transmitters must be fully charged each time you start a new monitoring session. Otherwise, your
sensor will likely not remain operational until the end date of sensor wear period (14 days).
A complete charging cycle of the receiver takes about 4 hours. For the transmitter it takes about 2
hours when using the supplied USB adapter plugged into a standard household electrical outlet
(100 to 240V AC, 50/60 Hz). It is recommended to use only the supplied USB cable and USB power
adapter.
CHARGING THE RECEIVER
WARNINGS :
Not Getting Urgent Alarm/Alert. There are no alarm/alerts, when your receiver is turned off or
its battery is dead.
PRECAUTIONS :
Use Charger as Directed. Use only the AC power adapter, USB cable and USB charger
provided with the RIGHTEST CGMs when charging your receiver and transmitter. Using
different chargers or AC power adapters could damage the system or cause fire.
Plug in to Charge. To best protect yourself from not getting the alarm/alerts due to a depleted
battery, plug in your receiver to its charger at the end of the day and charge it up overnight.

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Before Getting Started
1. Connect the micro-USB plug of the charging cable to
the USB Type C input of the receiver.
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Before Getting Started
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.
*
2

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Before Getting Started
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Before Getting Started
BATTERY LIFE INDICATOR ON THE RECEIVER
From the receiver 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
is charging, you will see lightning bolt in the middle of the battery icon. The receiver utilizes an
intelligent battery charging technology that prevents overcharging.
CHARGING TRANSMITTER
WARNINGS :
Not Getting Urgent Alarm/Alert. There are no alarm/alerts when your transmitter battery is
dead.
PRECAUTIONS Use only the AC power adapter, USB cable and USB charger provided with
the RIGHTEST CGMs when charging your receiver and transmitter. Using different chargers or
AC power adapter could damage the system or cause fire.
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. When connected to your personal computer’s
USB port or USB car charger adapter, it may take a longer time.

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Before Getting Started
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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 during entire wear
period (14 days).
1. Take out your transmitter charger from its storage vial. Hold the
charger face up.
2. Make sure the alignment notch of the transmitter is facing the
charger’s transmitter compartment with the transmitter mark
facing up. With the transmitter outer frame between your fingers,
steadily slide the transmitter all the way into the compartment.
1
2
Storage Vial
Transmitter Charger
Alignment
Notch
3. With the transmitter secured inside its charger compartment, turn
over the charger to the back side and slide the lock button
outwards.
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 240V AC, 50/60 Hz). You
can also charge your transmitter with a computer or a car charger
adapter with a USB port but it may take much longer.
3
Lock
Button
(in lock position)
4
* Accessories not included.
*
*

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Before Getting Started
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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.
6. After the transmitter is fully charged, unplug the transmitter charger from the power source.
7. If you wish to take out the transmitter from its charger, or to store the
transmitter charger, turn over the charger to the back side and press the
lock button slightly downward, then slide the lock button all the way inward.
NOTE :
If the LED doesn’t light up, make sure you connect to a power source with output rating of
500 mA or higher. If this does not solve the issue, check with another power source again then
contact customer support.
Fully charged
Charging

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Set Up Your RIGHTEST CGMs
VI. SET UP YOUR RIGHTEST CGMS
Before setting up your RIGHTEST CGMs, make sure you have everything you need:
The following steps describe using receiver to make a sensor-transmitter pair. If the instructions
provided do not work, the receiver will display an error message.
• Sensor Inserter Package
• Alcohol Wipes
• Transmitter • Receiver
• 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. 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.
1. Get your receiver.
2. If your receiver is OFF, press and hold the [Power] button for 2 seconds to turn ON.
If your receiver is ON, press the [Power] button briefly to wake up its display.
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Set Up Your RIGHTEST CGMs
NOTE :
If using the receiver for the first time, follow prompts to set the date, time and your glucose
target & alerts.
2
Power Button

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Set Up Your RIGHTEST CGMs
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Set Up Your RIGHTEST CGMs
3. Tap [Home] at the bottom of your receiver screen.
Then, tap [New Monitor] to start a new monitoring
session.
34. When the receiver prompts you to pair the sensor &
transmitter, choose [Pair].
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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
engraved with a mark.
5
NFC panel
6. Tap the receiver’s NFC panel against the tag on top
of the sensor inserter package until you hear a “beep”
sound.
NOTE :
Be sure your receiver’s NFC panel is within 1 cm
(3/8”) of the NFC tag/mark when you scan the
codes.
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Set Up Your RIGHTEST CGMs
6
NFC Tag