FOR-A GTel User manual

Multi-Functional Monitoring System
Sistema de monitoreo multifuncional
Owner’s Manual
Manual del Propietario
This device is not intended for use in healthcare or assisted-use
settings such as hospitals, physician offices, or long-term care
facilities because it has not been cleared by FDA for use in these
settings, including for routine assisted testing or as part of glycemic
control procedures.
Use of this device on multiple patients may lead to transmission of
Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV),
Hepatitis B Virus (HBV), or other bloodborne pathogens.


Dear FORA GTel System Owner:
Thank you for purchasing the FORA GTel Multi-Functional Monitoring
System. This manual provides important information to help you to use
the system properly. Before using this system, please read and follow
the instructions in this Owner's Manual.
Regular monitoring of your blood glucose and β-ketone levels can help
you and your healthcare professional gain better control of your
diabetes. Due to its compact size and easy operation, you can use the
FORA GTel Multi-Functional Monitoring System to easily monitor your
blood glucose and β-ketone levels by yourself anywhere, any time.
If you have questions, just call Customer Care Service Center toll-free at
1-888-307-8188 (8:30 am - 5:00 pm PST, Mon. - Fri.). For assistance
outside these hours, please contact your healthcare professional.
Version 4.0 2019/07
311-4122100-003
English


TABLE OF CONTENTS
BEFORE YOU BEGIN 1
Intended Use 1
Test Principle 1
Contents of System 2
Meter Overview 3
Setting the Meter 4
BEFORE TESTING 6
Checking the Code Number (for β-ketone) 6
TESTING WITH BLOOD SAMPLE 7
Preparing the Lancing Device for Blood Testing 7
Preparing the Puncture Site 7
Performing a Blood Glucose/β-ketone Test 8
METER MEMORY 11
Reviewing Test Results 11
Reviewing Blood Glucose Day Average Results (Glucose) 11
TWO-WAY MESSAGES 13
SERVICE BUTTON 13
MAINTENANCE 15
Battery 15
Recharging the battery 16

SYSTEM TROUBLESHOOTING 17
Blood Glucose Result Readings 17
β-Ketone Result Readings 17
Error Messages 18
Troubleshooting 20
SPECIFICATIONS 21

1
BEFORE YOU BEGIN
The FORA GTel Multi-Functional Monitoring System consists of the
FORA GTel Blood Glucose Test Strips, FORA GTel Blood β-ketone Test
Strips, and the FORA GTel meter.
The FORA GTel Multi-Functional Monitoring System is intended for use
in the quantitative measurement of glucose and β-ketone in fresh
capillary whole blood from the finger.
It is intended for in vitro diagnostic use by people with diabetes mellitus
at home as an aid in monitoring the effectiveness of your diabetes
control program. It is not intended for the diagnosis of or screening for
diabetes mellitus, and is not intended for use on neonates. It is
intended to be used by a single person and should not be shared.
Your system measures the amount of sugar (glucose) and β-ketone in
whole blood. The glucose and β-ketone testing is based on the
measurement of electrical current generated by the reaction of glucose
and β-ketone with the reagent of the strip. The meter measures the
current, calculates the blood glucose and β-ketone levels, and displays
the result. The strength of the current produced by the reaction
depends on the amount of glucose and β-ketone in the blood sample.
Intended Use
Test Principle

2
The FORA GTel system kit includes:
○
1Meter ○
6USB Cable
○
2Owner’s Manual ○
7USB Adapter
○
3Protective Wallet ○
8Glucose and β-Ketone Control
Solution (optional)
○
4Quick Start User Guide
/
Warranty Card
○
9Blood Glucose Test Strips and
β-Ketone
T
est Strips (optional)
○
5Rechargeable Li-Ion
Batter
y
(installed)
○
10 Lancets and Lancing Device
(optional)
○
11 SIM Card (installed)
Test strips, control solution, sterile lancets and lancing device may be
purchased separately. Please make sure you have those items needed
for a blood test beforehand.
NOTE:
If any items are missing from your kit or opened prior to use, or to obtain test
strips and control solutions, please contact customer service or your healthcare
professional.
Contents of System

3
○
1Test Slot with Strip Indication
Light
Insert test strip here to enter
measuring mode.
○
2Power Button
Power On / Off the meter.
○
3Power Indicator
○
4Home Button
Press this button to return to
Main Page.
○
5Display Screen
○
6Test Strip Ejector
Eject the used test strip by
sliding forward.
○
7Battery Compartment
○
8Service Button
Contact care service provider.
Not intended for emergency
situations.
○
9Micro-USB Port
For charging the battery only.
Meter Overview

4
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings. Make sure you
complete the steps below and have your desired settings saved.
Entering the Setting Mode
Power on the meter (with no test strip inserted). Tap Settings on the
Main Page.
1. Setting the reminder alarm
Tap Alarm on the Settings page.
Your meter has four reminder alarms. Tap the time field to set the alarm
time. Tap ON/OFF to enable/disable alarms.
2. Choosing a language
Tap Language on the Settings page. Select the appropriate language
for use. Tap Back.
3. Setting the speaking volume
Tap Volume on the Settings page.
There are four (4) speaking volume levels to choose from. Select the
desired speaking volume. Tap Back.
4. Setting the time
Tap Time on the Settings page.
Tap ˄or ˅to set the correct date. Press OK.
Tap ˄or ˅to set the correct time. Press OK.
5. Setting the flight mode
Tap Flight mode on the Settings page to switch ON/OFF flight mode.
Setting the Meter

5
6. Setting the hi/low range for blood glucose measuring parameters
Tap Next on the bottom of Settings page to go to the next settings page.
Tap BG Range.
Glucose:
Three measuring modes are displayed on the screen: No Tag/Before
Meal/After Meal. Tap each mode to set the hi/low range for each
measurement.
The hi/low range will affect the background color of your glucose test
result.
If your test result is higher than the normal range, the background will
be red. If it is lower than the normal range, the background will be
yellow. The background will be green when readings are within the set
threshold.
Congratulations! You have completed all settings!
NOTE:
These parameters can ONLY be changed in the settings page.
If the meter is idle for 3 minutes during the settings mode, it will switch off
automatically.

6
BEFORE TESTING
A code strip should be inserted prior using a new box of ketone test
strips. You need to make sure that the code number displayed on the
meter matches the number on the test strip vial before you proceed. If it
matches, you can proceed with your test. If the codes do not match,
please stop testing and contact Customer Service for help.
NOTICE:
The code number on the display is only for your reference, it may not be the
actual code for your meter.
WARNING:
It is important to make sure that the LCD displayed code is the same as the
code on the test strip vial before testing. Failure to do so will get inaccurate
results.
If the LCD displayed code is not the same as the code on the test strip vial, and
the code number cannot be updated, please contact Customer Service for
assistance.
Checking the Code Number (for β-ketone)

7
TESTING WITH BLOOD SAMPLE
WARNING:
To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet. Lancets are for single use only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the
lancing device.
Wash and dry your hands thoroughly after handling the meter, lancing device
and test strips to prevent infection. For more information, please refer to the
MAINTENANCE section.
If the meter is being operated by a second person who is providing testing
assistance to the user, the meter and lancing device should be
decontaminated prior to use by the second person.
Sharing the lancing device and lancets may increase the risk of
spreading infectious diseases. Lancing device must not be used on
more than one person.
Please follow the instructions in the lancing device insert for collecting a
blood sample.
Stimulating blood perfusion by rubbing the puncture site before blood
extraction significantly reduces variations between measurements.
Please follow the suggestions below before obtaining a drop of blood:
Wash and dry your hands before starting.
Select the puncture site on fingertips.
Rub the puncture site for about 20 seconds before penetration.
Clean the puncture site using cotton moistened with 70% alcohol and let
it air dry.
Preparing the Lancing Device for Blood Testing
Preparing the Puncture Site

8
►Fingertip testing
Hold the lancing device firmly against the
lower side of your fingertip. Press the
release button to puncture your finger.
NOTE:
Choose a different spot each time you test. Repeated punctures at the same
spot may cause soreness and calluses.
It is recommended that you discard the first drop of blood as it might contain
tissue fluid, which may affect the test result.
1. Power on the meter
(Do NOT insert a test strip before
powering on the meter)
2. Tap Measure or insert the test strip
to start a measurement
Voice Guide
Please relax during measurement.
(For β-ketone Test)
Make sure the code number on the
screen is the same as the number on
the vial.
Voice Guide
The code number is (number).
Wait for the meter to display “Take a
blood sample”.
Performing a Blood Glucose/β-ketone Test

9
Voice Guide
Please apply blood onto the strip.
3. Obtaining a blood sample
Use the preset lancing device to
puncture the desired site.
4. Bring strip to sample
Gently bring the strip to the sample so
that the absorbent hole can sip in the
blood.
NOTE:
Do not press the punctured site against the test strip or try to smear the blood.
The confirmation window should be filled with blood before the meter begins to
count down. NEVER try to add more blood to the test strip after the drop of
blood has moved away. Discard the used test strip and retest with a new one.
If you have trouble filling the confirmation window, please contact your
healthcare professional or the local customer service for assistance.
5. Read your result
The result of your test will appear after
the meter counts down to 1. The result
will be stored in the memory
automatically.
Voice Guide
Your blood glucose is (number)
milligrams per deciliter.
Your β-ketone is (number) millimoles per
liter.

10
6. Select the appropriate measuring
mode
For glucose tests, there are three
modes for measuring: No Tag (General),
Before Meal (AC) and After Meal (PC).
For β-ketone tests, there is one mode
for measuring, General Test. There is no
need to set a measuring mode after the
test result is shown.
If your test result is higher than the
normal range, the background will be
red. If it is lower than the normal range,
the background will be yellow. The
background will be green when readings
are within the set threshold.
7. Eject the used test strip
Eject the test strip by sliding the eject
button forward.
8. Transmitting data
The meter automatically transmits new
data after each measurement.
When removing the lancet, follow the instructions from the lancing
device insert.
WARNING:
The used lancet and test strips may be biohazardous. Please discard them
properly.
Wash and dry your hands thoroughly after handling the meter, lancing device
and test strips to prevent infection. For more information, please refer to the
MAINTENANCE section.

11
METER MEMORY
Your meter stores the 1,000 most recent test results with date and time
in its memory. To enter the meter memory, tap the Logbook icon on the
Main Page.
1. Tap Logbook icon on the Main Page
The first reading you see is the last test
result along with date, time and the
measurement mode.
Tap ˄or ˅to recall the test results
stored in the meter.
2. Tap tab to check the blood
glucose 7-day average test results in
chart form.
Tap ˄or ˅to review more past results.
1. Tap AVG tab
Your 7-, 14-, 21- day average results
measured in No Tag mode will appear
on the display. Tap ˄or ˅to review 28-,
60-, 90- day average results.
2. Tap Before Meal/After Meal to review
7-, 14-, 21-, 28-, 60- and 90- day average results stored in each
measuring mode.
Reviewing Test Results
Reviewing Blood Glucose Day Average Results (Glucose)

12
3. Exit the meter memory
Press the Home button to return to the Main Page.
NOTE:
Any time you wish to exit the memory, press the Home button.
Control solution results are NOT included in the day average.
If there are no records in memory, “---“ displays when you recall the test results
or review the average results.
The blood glucose test results of “Lo” and “Hi” will NOT be calculated in the day
average results.
Remarks about data security:
The device will only transmit your measurement data in a secured
and encrypted way to the data server that your care service provider
manages. No personally identifiable information will be covered and
revealed. Please contact your care service provider to learn more
about their privacy policy regarding your measurement data.
When you use the meter for the very first time, it’s highly
recommended that you contact your service provider to confirm that
the transmission to your account at the server side is correct and
successful.
You can stop the data transmission option by contacting your care
service provider.

13
TWO-WAY MESSAGES
FORA GTel is equipped with two-way message function to provide you
with health tips and reminders. Types of messages include yes/no
questions, multiple-choice questions and alert messages. You can click
on the answer icons to answer the questions.
After entering the message box, the screen displays the most recent
message. You can click Previous or Next button to move to the previous
or next message.
You can upload your answer onto the database and download new
messages from the website.
Press Home Button to return to the Main Page.
You can tap the text options in blue to switch between
the answers.
Once you answer the question, the texts and answer
icons turn grey. You can’t change your selection then.

14
SERVICE BUTTON
The meter is equipped with a Service Button.
Pressing and holding the button for more than 3
seconds will send a Request Assistance to the care
service provider
For more information about the Service Button,
please contact customer service or your healthcare
professional.
Warning: The Service Button is not intended for an emergency. Please
DO NOT expect an instant response or immediate assistance by
pressing this button. Your care service provider will define the service
agreement with you.
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