FOR-A Test N'GO Advance Voice User manual

Lactate Test System
Sistema de Prueba de Lactato
Owner’s Manual
Manual del Propietario

Dear FORA Test N’GO Advance
Voice System Owner:
Thank you for purchasing the FORA Test N’GO Advance Voice Lactate
Test System. This manual provides important information to help you
use the system properly. Before using this system, please read and
follow the instructions in this Owner's Manual.
The system measures lactate levels. Due to its compact size and easy
operation, you can use the FORA Test N’GO Advance Voice Lactate
Test System to easily monitor your lactate levels anywhere, any time.
If you have other questions regarding this product, please contact the
place of purchase or call our customer service line at 1-888-307-
8188 (6:30 am - 5:30 pm PST, Mon. - Fri.). For any further medical
assistance, please contact your healthcare professional.
Version 1.0 2023/08
311-4183600-008
English

IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
 For over-the-counter use only.
 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)
https://wayback.archive-it.org/7993/20170111013014/
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm
224025.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
 Use this device ONLY for the intended use described in this manual.
 Do NOT use accessories which are not specified by the
manufacturer.
 Do NOT use the device if it is not working properly or if it is
damaged.

 Do NOT under any circumstances use the device on newborns or
infants.
 This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only. Always consult your doctor
to have the results interpreted.
 Before using this device to test lactate, read all instructions
thoroughly and practice the test. Carry out all the quality control
checks as directed.
 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.
 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.
 Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
 Proper maintenance and periodical control solution tests are
essential to the longevity of your device. If you are concerned about
your accuracy of measurement, please contact customer service or
place of purchase for help.
 This device is NOT intended for use in screening or diagnosis of
familial or acquired genetic disorders, including inborn errors of
metabolism.
 This device is NOT intended for assessing the risk of cardiovascular
diseases.

 This device is NOT intended for near patient testing (point of care).
 This device is NOT intended for use in healthcare or assisted-use
settings such as hospitals, physician offices, or long-term care
facilities. 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.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

TABLE OF CONTENTS
BEFORE YOU BEGIN 1
Important Information 1
Intended Use 2
Test Principle 2
Contents of System 3
Meter Overview 4
Meter Display 5
Speaking Function 6
Test Strip 7
Setting the Meter 8
MEASURING MODE 12
One Measuring Mode for Lactate Testing 12
BEFORE TESTING 13
Calibration for Testing 13
How to Code Your Meter 13
Checking the Code Number 14
Control Solution Testing 14
Performing a Control Solution Test 15
TESTING WITH A BLOOD SAMPLE 18
Preparing the Lancing Device for Blood Testing 18

Preparing the Puncture Site 18
Performing a Lactate Test 19
METER MEMORY 22
Reviewing Test Results 22
DOWNLOADING THE RESULTS 23
Data Transmission via Bluetooth 23
MAINTENANCE 25
Battery 25
Caring for Your Meter 26
Disinfecting Procedures 27
Caring for Your Test Strips 30
Cleaning and Disinfecting Your Lancing Device 30
Important Control Solution Information 31
SYSTEM TROUBLESHOOTING 32
Result Readings 32
Error Messages 33
Troubleshooting 34
DETAILED INFORMATION 35
Reference Values 35
SPECIFICATIONS 36
FEDERAL COMMUNICATIONS COMMISSION (FCC) STATEMENT 38

1
BEFORE YOU BEGIN
●Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
●If your lactate results are lower or higher than usual, and you do not
have any symptoms of illness, first repeat the test. If you have
symptoms or continue to get results which are higher or lower than
usual, follow the treatment advice of your healthcare professional.
●Use only fresh capillary whole blood samples from fingertips to test
your lactate. Using other substances will lead to incorrect 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 in shock. Please consult your healthcare
professional before use.
Important Information

2
The FORA Test N’GO Advance Voice Lactate Test System is intended
for the quantitative measurement of lactate in fresh capillary whole
blood from the fingertips. The FORA Test N’GO Advance Voice Lactate
Test System is intended for self-testing outside the body (in vitro
diagnostic use) by lay user as an aid in measuring the lactate. The
system is not intended for the diagnosis of or screening for diseases,
and is not intended for use on neonates.
Your system measures the amount of lactate in fresh capillary whole
blood samples from fingertips. The lactate testing is based on the
measurement of electrical current generated by the reaction of lactate
with the reagent of the strip. The meter measures the current,
calculates the lactate level, and displays the result. The strength of the
current produced by the reaction depends on the amount of lactate in
the blood sample.
Intended Use
Test Principle

3
The FORA Test N’GO Advance Voice Lactate Test System kit
includes:
○
1
Meter ○
7
10 Lactate Test Strips
○
2
Owner’s Manual ○
8
Control Solution
○
3
Protective Wallet ○
9
Lactate Code Strip
○
4
Quick Start User Guide
/ Warranty Card
○
10
10 Lancets
○
11
Lancing Device
○
5
Daily Log Book ○
12
Lactate Strip Manual
○
6
2 x 1.5V AAA Batter
y
○
13
Lancing Device Manual
Test strips, control solution, sterile lancets and lancing device may be
purchased separately. Please make sure you have those items needed
for a lactate 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 the place of purchase or call
Customer Service for assistance.
Contents of System

4
○
1
Test Strip Slot
Insert test strip here to turn
the meter on for testing.
○
2
Strip Indication Light
○
3
Bluetooth Indicator
Download test results with a
Bluetooth connection.
○
4
Test Strip Ejector
Eject the used strip by
pushing up this button.
○
5
Display Screen
○
6
◄Button
○
7
MAIN Button
Enter the meter memory.
○
8
►Button
Can be used to silence a
reminder alarm.
○
9
Battery Compartment
Meter Overview

5
○
1
Lactate Testing ○
8
Alarm Symbol
○
2
Test Result ○
9
Measurement Unit
○
3
Low Battery Symbol ○
10
Volume Symbol
○
4
Measuring Mode ○
11
Test Strip Symbol
○
5
Memory Symbol ○
12
Blood Drop Symbol
○
6
Error Message ○
13
Code
○
7
Date / Time
Meter Display

6
The meter “speaks” aloud with step-by-step instructions to guide you
through the process of using the meter. The following table tells you
when and what the monitor “speaks”.
WHEN does the meter speak? WHAT does the meter say?
When turning on the meter Please relax during measurement.
When the test is completed.
(result appears on display)
Lactate is (number) millimoles per
liter.
After inserting a test strip The code number is (number).
Please apply blood into the strip.
Measuring warning Lactate is out of range, unable to
measure.
NOTICE: You can press MAIN to skip the voice when the meter
“speaks”.
Speaking Function

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 Test N’GO Advance Voice Lactate Test System should only be
used with FORA Test N’GO Advance Voice Lactate 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
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
Start with the meter off (no test strip
inserted). Press ◄and ►buttons at
the same time to enter Setting Mode.
1. Setting the date
With the year flashing, press ◄/►
button until the correct year appears.
Press MAIN.
With the month flashing, press ◄/►
button until the correct month
appears. Press MAIN.
With the day flashing, press ◄/►
button until the correct day appears.
Press MAIN.
2. Setting the time
With the hour flashing, press ◄/►
button until the correct hour appears.
Press MAIN.
With the minute flashing, press ◄/►
button until the correct minute
appears. Press MAIN.
Setting the Meter

9
3. Deleting the memory
With “dEL” and “ ” on the display,
press ►button and select “no” to
keep the results in memory then press
MAIN to skip.
To delete all the results, press ►
button and “yes” and “
” will be
displayed on the meter, press MAIN to
delete the memory.
4. Setting the speaking volume
There are seven (7) speaking volume
levels to choose from. Press ◄/►
until the desired speaking volume
appears. To confirm your selection,
press MAIN.
Volume 0 indicates that the speaking
function is turned off, and “ ” will
not display during testing. Volume 1 to
7 indicates speaking volume from low
to high, and “ ” will be displayed
throughout the testing.

10
5. Choosing a language
Press ◄/►to select L1/L2/L3. The
default language for the meter is L1,
which is English. L2 is for Spanish,
and L3 is for Chinese (Mandarin). To
confirm your selection, press MAIN.
6. Setting the reminder alarm
You may set up any or all of the
reminder alarms (1-4). The meter
displays "OFF", " " and "AL1"; press
◄/►button to turn on or turn off to
set the first reminder alarm.
Press ◄/►button to select “On”, and
then press MAIN to set the hour.
When the hour is flashing, press ◄/►
button to set an hour. Press MAIN to
confirm and go to minutes, and then
press ◄/►button to set minutes.
Press MAIN to confirm and go to the
next alarm setting.

11
If you do not want to set an alarm, press MAIN to skip this step. If you
want to turn off an alarm, select the alarm number by pressing MAIN
in the setting mode, and then press ◄/►button to change displayed
message from “On” to “OFF”.
At the pre-set alarm time, the meter will beep and automatically turn
on. You can press ►button to mute the alarm and insert a test strip
to begin testing. If you do not press ►button, the meter will beep for
2 minutes and then switch off.
Congratulations! You have completed all settings!
NOTE:
 These settings can ONLY be changed in the setting mode.
 If the meter is idle for 3 minutes during the setting mode, it will switch off
automatically.

12
MEASURING MODE
The meter provides you with one mode for lactate testing: General.
MODE USE WHEN
General any time of day without regard to time since
last meal
Start with the meter switched off.
Insert a lactate test strip to turn on the
meter. The screen will display: “ ” and
“LAC”.
One Measuring Mode for Lactate Testing