BIONIME RIGHTEST Max User manual

101-3HR320-XXX EN
User Manual
Rev. Date: 2021-11
Continuous Glucose
Monitoring System
BIONIME CORPORATION
No. 100, Sec. 2, Daqing St., South Dist.,
Taichung City 40242, Taiwan
Tel: [phone]
Fax: [phone]
Email: [email protected]om
http://www.bionime.com Use with a receiver
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. Discuss with your healthcare professional for management of the
diabetes with the assistance of RIGHTEST Continuous Glucose Monitoring System. Failure to
operate the system according to the guidelines and safeguards specified in this manual could
result in a hazardous condition. If your glucose readings do not match what you are feeling,
use your blood glucose meter; or, if needed, consult your healthcare practitioner.
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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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 TREND ARROW AND ARROW COLOR
ADD NOTES
ACCESS YOUR NOTES INFORMATION
HIGH/LOW READING
X. CALIBRATION AND Wi-Fi CONNECTION (OPTIONAL)
CALIBRATE
Wi-Fi CONNECTION
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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 2 to 80 in home healthcare. It's an applied part and it is designed to replace fingerstick 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.
CONTRAINDICATION :
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.
People who are not able or not willing to contact with their healthcare professional are
not recommended to use the RIGHTEST CGMs. Sufficient vision or hearing is critical for
successful usage of system including effective recognition of the alerts. Do not use any
component of the RIGHTEST CGMs with any product not in this system.
WHEN NOT TO USE: 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.

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Safety Information
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Safety Information
• 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 meters/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. All components of the RIGHTEST CGMs are not
allowed to be used with any product not in this system. 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.
WARNINGS :
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 system 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 system.
• 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.
Not Getting Urgent Alarm. The RIGHTEST CGMs Receiver lets you know when your sensor
readings drop to or below 54 mg/dL regardless your alarm/alert settings. There are no alarm
in the following situations.

PRECAUTIONS :
Calibration Safety: Calibration is not required if users scan sensor & transmitter codes.
Otherwise, Only use fingerstick blood glucose value to calibrate your system for accurate
readings. Take additional precautions when you enter your fingerstick blood glucose value.
Entering incorrect fingerstick blood glucose values or blood glucose values from other places
for calibration can result in inaccurate glucose readings, which may result in you missing a
high or low glucose event.
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 healthcare 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 or any components of the
RIGHTEST CGMs. Insect repellent may damage the plastic used in the RIGHTEST CGMs.
Failure to comply may lead to inaccurate system performance or reduction of stickiness of
sensor adhesive.
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Safety Information
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Safety Information
Store the Sensor in a Cool and Dry Place: Store the sensor in a cool, dry place between 5°C
to 30°C (41°F to 86°F) and between 10-90% non-condensing humidity. If the temperature may
be higher than 30°C (86°F), refrigerate your sensor and do NOT freeze the sensor or leave the
sensor in a parked car on a hot day. Avoid direct sunlight, extreme temperatures, or humidity.
These conditions may damage the sensor and cause inaccurate sensor glucose readings.
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. Re-sterilization of these components may
result in no glucose readings and infections.
Use as Directed: Use only the AC power adapter, USB cable and USB charger provided with
the RIGHTEST CGMs when charging your receiver and transmitter. The AC power adapter,
USB cable and USB charger provided with RIGHTEST CGMs comply safety regulations for
medical devices. Using different chargers or AC power adapters could damage the system
or cause fire. Make sure the access to the power adapter is not blocked and it can be easily
unplugged due to the potential risk of electrical shock. 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 It Could Fall into Water. Do not spill liquids on receiver or submerge it in
water or other liquids. 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 could result in electric shock or
no glucose results.
DO NOT Use If Any Component Appears to be Damaged. A damaged or cracked inserter,
sensor, transmitter, or receiver could compromise the integrity of the system or contribute to
infection risk.
Traveling by Air. Always check and follow flight rules or regulations before departure. Notify
the security personnel of the presence of the RIGHTEST CGMs and ask for pat-downs,
visual inspection, and walk through metal detectors. You must comply any requests by
airline personnel (e.g. turning off the system). Don’t pass through an advanced imaging
technology (AIT) body scanner (e.g. millimeter wave scanners) or put RIGHTEST
CGMs components through x-ray machines since the effects of these equipment are not
evaluated.
Not Allowed to Changing Time Zone. You are not allowed to change time zone during the
14-day of monitoring. Changing the time or date settings in the period of monitoring may
result in gaps in the graph or hidden glucose readings.
Keep an Emergency Kit with You. Make sure necessary supplies are always available. Let
your family, co-worker, or friend know where the emergency kit is. The emergency kit should
contain:
• Fast-acting glucose tablets.
• Blood glucose monitoring supplies.
• Insulin syringe and rapid-acting insulin (with dosage instructions from your healthcare
professional).
• Adhesive dressing.
• Glucagon™ emergency kit.
Trouble Shooting If any situation not mentioned in this user manual happens, please contact
your healthcare professional or Customer Service.
Be Careful of Electromagnetic Disturbance. Stacking or collocating equipment, or using AC
power adapter, USB cable and USB charger not provided with RIGHTEST CGMs may bring
negative influence on electromagnetic compatibility. Stay a distance no closer than 30 cm
(12 inches) to any part of any portable RF communications equipmentand at least 1 meter
for sensitive equipment. If abnormal behavior is observed due to EM disturbances, please
relocate the device accordingly.

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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 from touch by fingers and objects greater
than 12.5 millimeters. Protected from dripping water
when tilted at 15°.
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
Discard this product according to local regulations 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 : CGM readings and 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 to or below 54 mg/dL.
• Urgent alert/alarm settings at 54 mg/dL or below 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 high/low glucose
readings
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 :
Plug in to Charge. To best protect yourself from not getting the alarm/alerts due to a depleted
battery, plug in your receiver to charge at the end of the day and charge it up overnight.
Confirm Charging Status Instability of power resource may cause missing of charging icon.
Check the status of charging by the battery status icon (charging or discharging) is displayed
in the top-right corner of the screen. When the receiver is plugged in, you should see lightning
bolt in the middle of the battery icon.
Prevent Operation during Charging Operation during charging may bring risk.

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Before Getting Started
1. Connect the USB Type C 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.
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 :
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.

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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 transmitter metal
components facing down. 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).
3
Lock
Button
(in lock position)
4

3130
Before Getting Started
5
7
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 monitoring session. If the instructions
provided do not work, please contact Customer Service for further assistance.
• 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 is the opposite face
of its metal components. 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.
NOTE :
To clean the receiver, use a soft, dry, lint-free cloth and avoid
using aerosol sprays, solvents, alcohol wipes, or abrasives.
Abrasive cloths, towels, paper towels, or similar items may
damage the receiver and are not recommended to use for
cleaning it. Make sure liquid, dust, dirt, bleach, or any other
substance does not get into any opening. Unplug the receiver
from USB cable and turn it off before cleaning.
2
Power Button

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Set Up Your RIGHTEST CGMs
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Set Up Your RIGHTEST CGMs
3. Tap [New Monitor] to start a new monitoring session.
3
4. 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.
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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