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 2.0 2019/02
311-4122100-xxx
English

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
The meter and lancing device are for single patient use only. Do not
share them with anyone including your family members! Do not use
on multiple patients!
All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed cleaning
and disinfection.
For more information, please visit
“FDA Public Health Notification: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne Pathogens:
Initial Communication” (2010)
http://wayback.archive-it.org/7993/20170111013014/http:/www.f
da.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens” (2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the
manufacturer.
3. Do NOT use the device if it is not working properly or if it is
damaged.
4. Do NOT under any circumstances use the device on newborns or
infants.
5. This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only.

6. Before using this device to test blood glucose and β-ketone, read all
instructions thoroughly and practice the test. Carry out all the
quality control checks as directed.
7. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets
and vial caps are choking hazards. If swallowed, consult a doctor
immediately for advice.
8. Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.
9. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
10. Proper maintenance and periodically control solution test are
essential to the longevity of your device. If you are concerned about
your accuracy of measurement, please contact the local customer
service or your healthcare professional for help.
11. Use only FORA GTel Test Strips with FORA GTel Multi-Functional
Monitoring System to obtain accurate results, and be covered by
the manufacturer’s warranty.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN 1
Important Information 1
Limitations 1
Intended Use 3
Test Principle 3
Contents of System 4
Meter Overview 5
Meter Display 6
Test Strip 7
Turning ON and Setting up Your Meter 8
Sleeping and Turning Off Your Meter 8
Setting the Meter 9
MEASURING MODES 12
Three Measuring Modes for Blood Glucose Testing 12
One Measuring Mode for β-ketone Testing 12
BEFORE TESTING 13
Checking the Code Number (for β-ketone) 13
Control Solution Testing 13
Performing a Control Solution Test 14
TESTING WITH BLOOD SAMPLE 16
Preparing the Lancing Device for Blood Testing 16
Preparing the Puncture Site 16
Performing a Blood Glucose/β-ketone Test 17
METER MEMORY 21
Reviewing Test Results 21
Reviewing Blood Glucose Day Average Results (Glucose) 21

UPLOADING TEST RESULTS 23
Data transmission via Mobile Network 23
TWO-WAY MESSAGES 27
STAY SAFE WITH THE SERVICE BUTTON 28
MAINTENANCE 29
Battery 29
Recharging the battery 29
Caring for Your Meter 30
Disinfecting Procedures 31
Caring for Your Test Strips 33
Important Control Solution Information 34
SYSTEM TROUBLESHOOTING 35
Blood Glucose Result Readings 35
β-Ketone Result Readings 35
Error Messages 36
Troubleshooting 38
DETAILED INFORMATION 39
Reference Values 39
Comparing Meter and Laboratory Results 40
PERFORMANCE CHARACTERISTICS 42
FORA GTel Blood Glucose Test Strips 42
FORA GTel β-Ketone Test Strips 43
SPECIFICATIONS 45

1
BEFORE YOU BEGIN
Severe dehydration and excessive water loss may cause readings that
are lower than actual values. If you believe you are suffering from
severe dehydration, consult a healthcare professional immediately.
If your blood glucose or β-ketone results are lower or higher than
usual, and you do not have symptoms of illness, repeat the test. If you
have symptoms or continue to get results that are higher or lower
than usual, follow the treatment advice of your healthcare
professional.
Use only fresh whole blood samples to test your blood glucose and
β-ketone. Using other substances will lead to inaccurate results.
If you are experiencing symptoms that are inconsistent with your test
results and you have followed all the instructions given in this owner’s
manual, contact your healthcare professional.
We do not recommend using this product on severely hypotensive
individuals or patients who are in shock. Readings that are lower than
actual values may occur for individuals in a
hyperglycemic-hyperosmolar state, with or without ketosis. Please
consult your healthcare professional before use.
For in vitro diagnostic use (for use outside of the body only).
For single-patient use only.
This system should not be used for the diagnosis of, or screening for
diabetes.
Important Information
Limitations

2
This system is not for use in patients with abnormally low blood
pressure.
Inaccurate results may occur in severely hypotensive individuals or
patients in shock. Inaccurate low results may occur for individuals
experiencing a hypoglycemic hyperosmolar state, with or without
ketosis.
This system should not be used on neonates or critically ill patients.
This system should not be used on patients with impaired peripheral
circulation, severe dehydration as a result of diabetic ketoacidosis or
severe hyperglycemia, hyperosmolar non-ketotic coma or shock.
Altitudes above 10,742 feet may cause inaccurate results.
Acetaminophen in your blood (> 20 mg/dL) might affect the reliability
of your blood glucose results. If you are taking Tylenol, or other
acetaminophen containing drugs, your glucose results may not be
reliable. If you are unsure, then ask your healthcare professional.
If you have a disease or condition that elevates your blood uric acid
level (>10 mg/dL), such as gout, your blood glucose results may not
be reliable. If you are unsure, then ask your healthcare professional.
If you are taking high doses of Tolazamide (> 20 mg/dL in your blood),
then you should know that this drug might affect the reliability of your
blood glucose results. If you are unsure, then ask your healthcare
professional.
Xylose: Do not test blood glucose during or soon after a xylose
absorption test. Xylose in the blood can give falsely elevated results.
Pralidoxime iodide level to >5 mg/dL may affect the glucose results. If
you are unsure, then ask your healthcare professional.

3
The FORA GTel Multi-Functional Monitoring System consists of the
FORA GTel Blood Glucose Test Strip, FORA FORA GTel Blood β-ketone
Test Strip, 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 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 level, 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

4
The FORA GTel system kit includes:
○
1
Blood Glucose Meter ○
6
USB Cable
○
2
Owner’s Manual ○
7
USB Adapter
○
3
Protective Wallet ○
8
Glucose Control Solution
(optional)
○
4
Quick Start User Guide /
Warranty Card
○
9
Blood glucose test strips
and β-ketone test strips
(optional)
○
5
Rechargeable Li-Ion
Batter
y
○
10
Lancets and Lancing Device
(optional)
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

5
○
1
Test Slot with Strip Indication
Light
Insert test strip here to enter
measuring mode.
○
2
Power Button
Power On / Off the meter.
○
3
Indicator
○
4
Home Button
Press this button to back to
Main Page.
○
5
Display Screen
○
6
Test Strip Ejector
Eject the used strip by pushing
up this button
○
7
Battery Compartment
○
8
Service Button
Contact care service provider
○
9
Micro-USB Port
For charging the battery only
Meter Overview

6
○
1
Measuring Mode
○
2
Sync
○
3
Logbook
○
4
Settings
○
5
Two-way Message
○
6
Last Test Result and
Measuring mode
○
7
Date & Time
○
8
Battery Symbol
○
9
RF Symbol
NOTE:
Your meter display alternates between two kinds of results every 3 seconds,
one being your last measurement result, and the other being your blood
glucose 7-day average, if there is.
If there are no records in memory, the meter displays “---”.
Meter Display

7
ATTENTION:
The front side of test strip should face up when
inserting test strip.
Test results might be wrong if the contact bar is not
fully inserted into the test slot.
NOTE:
The FORA GTel Multi-Functional Monitoring System should only be used with
FORA GTel Test Strips. Using other test strips with this monitoring system can
produce inaccurate results.
1. Absorbent Hole
Apply a drop of blood here. The blood will be
automatically absorbed.
2. Confirmation Window
This is where you confirm if enough blood has
been applied to the absorbent hole in the strip.
3. Test Strip Handle
Hold this part to insert the test strip into the
meter slot
4. Contact Bars
Insert this end of the test strip into the meter.
Push it in firmly until it stops.
Test Strip

8
You need to do very little to set up and use your meter. When you
receive the meter, it may be partially charged but check to make sure
that the battery is full before using it for the first time. To check the
battery status, look at the battery gauge icon in the top right corner of
the screen.
By pressing the Power button on top of the meter, the FORA logo will
appear. You should tab SETTINGS to enter setting mode. Make sure to
finish the settings before you begin the measurement for the first time.
You do not have to enter settings every time you use the meter. This is
to make sure that your readings are sent with right time stamp. Having
the correct time and date of each blood test result is important because
it helps you and your healthcare professional understand your blood
glucose patterns and can be used to introduce changes in your
management plan.
Power on the meter. Tap Measure or insert the test strip to start a
measurement. You can also begin measurement by inserting a test strip
regardless of which page you are at. Even when the meter is on sleep
mode, inserting a test strip will initiate the measurement procedures.
Please note that we do not recommend you inserting a test strip when
the meter is transmitting data.
To save battery, the screen on your meter will go to sleep mode after 1
minutes of non-use. When left idle for more than 3 minutes with no
inserted strip, the meter will turn off automatically. To turn off your
meter completely, just hold in the POWER button until the device
powers off. You can turn on the meter by pressing the POWER button.
Turning ON and Setting up Your Meter
Sleeping and Turning Off Your Meter

9
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 (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.
Setting the Meter

10
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.
6. Setting the hi/low range for blood
glucose measuring parameter
Tap Next on the bottom of Settings
page to go to the next setting page. Tap
BG Range.

11
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 measuring.
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 is of the
color red. If it is lower than the normal
range, it is of the color yellow.
Congratulations! You have completed all settings!
NOTE:
These parameters can ONLY be changed in the setting page.
If the meter is idle for 3 minutes during the setting mode, it will switch off
automatically.

12
MEASURING MODES
The meter provides you with three modes for measuring: No Tag
(General), Before Meal (AC) and After Meal (PC).
MODES USE WHEN
No Tag
(General test)
any time of day without regard to time since
last meal
Before Meal (AC) no food intake for at least 8 hours
After Meal (PC) 2 hours after a meal
You can set the measuring mode to
each testing when the meter shows a
testing result.
The meter provides you with one mode for measuring, Gen. Follow the
instructions on the screen to insert a test strip into the meter. Wait for
the meter to display “Ketone strip” and the code number. There is no
need to set a measuring mode after the test result is shown.
Three Measuring Modes for Blood Glucose Testing
One Measuring Mode for β-ketone Testing