FOR-A Premium V10a User manual

Blood Glucose Monitoring System
Sistema de vigilancia de glucose sanguinea
Owner’s Manual
Manual del Propietario

3
Dear FORA Premium V10
System Owner:
Thank you for purchasing the FORA Premium V10 Blood Glucose
Monitoring System. This manual provides important information to help
you use the system properly. Before using this product, please read and
follow the instructions in this Ownerʼs Manual and any inserts for the test
strips and control solution.
Regular monitoring of your blood glucose levels can help you and your
doctor gain better control of your diabetes. Due to its compact size and
easy operation, you can use the FORA Premium V10 Blood Glucose
Monitoring System to easily monitor your blood glucose levels.
If you have questions, just call ForaCareʼs Customer Care Service Center
toll-free at 1-888-307-8188 (8:30am-5:00pm PST, Mon.-Fri.). You can
also visit www.foracare.com.
Version 3.0 2018/03
311-4124100-010
English

4
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
●The meter and lancing device are for single patient use. Do not share them
with anyone including other family members or use on multiple patients!
●All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have cleaned and disinfected
the components in the kit.
For more information, please visit
1.“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.fda.gov/
MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2.“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.
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 use the equipment where aerosol sprays are being used or where
oxygen is being administered.
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 your blood glucose, read all of the
instructions thoroughly, practice the test with the meter and perform all
quality control checks as directed.
7. Please use this device in a dry environment, especially when synthetic
materials are present ( clothing, carpets etc.). These materials give off
static discharges, which may cause erroneous results.
8. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.

5
9. Do not under any circumstances use the device on neonates or infants.
10. 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.
11. Proper maintenance and periodically checking the meters quality through
control solution tests, are essential to the longevity of your device. If you
are concerned about the accuracy of your measurement, please contact
your local customer service or place of purchase for help.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

6
TABLE OF CONTENTS
BEFORE YOU BEGIN 07
Important Information 07
Intended Use 08
Test Principle 08
Contents of System 09
Meter Overview 10
Display Screen 11
Test Strip 12
Setting the Meter 13
THE FOUR MEASURING MODES 16
Control Solution Testing 17
Performing a Control Solution Test 17
TESTING WITH BLOOD SAMPLE 20
Preparing the Puncture Site 20
Alternative Site Testing 22
Performing a Blood Glucose Test 23
METER MEMORY 26
Reviewing Test Results 26
Reviewing Blood Glucose Day Average Results 27
Downloading Results onto a Computer 28
MAINTENANCE 29
Battery 29
Caring for Your Meter 30
Caring for Your Test Strips 33
Important Control Solution Information 34
SYSTEM TROUBLESHOOTING 35
Result Readings 35
Error Messages 36
Troubleshooting 38
DETAILED INFORMATION 39
SPECIFICATIONS 40

7
BEFORE YOU BEGIN
Important Information
●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 blood glucose results are lower or higher than usual, and
you do not have any symptoms of illness, repeat the test. If you have
symptoms or continue to get results which are higher or lower than
usual, consult with your healthcare professional.
● Use only fresh whole blood samples to test your blood glucose. Using
other substances will lead to incorrect results.
●If you are experiencing symptoms that are inconsistent with your blood
glucose test results and you have followed all the instructions given in
this ownerʼs manual, contact your healthcare professional.
●We do not recommend using this product on severely hypotensive
individuals or patients in shock. Readings lower than actual values may
occur for individuals experiencing a hyperglycemic-hyperosmolar state,
with or without ketosis. Please consult a healthcare professional before
use.
●Critically ill patients should not be tested with a blood glucose
monitoring system.

8
Intended Use
The FORA Premium V10 Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary
whole blood from your finger and the following alternative sites: palm,
forearm and upper arm. It is intended for 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.
The alternative site testing in the FORA Premium V10 Blood Glucose
Monitoring System can be used only during steady-state blood glucose
conditions.
This meter has some speaking functions but is not intended for use by
the visually impaired.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
This system uses enzyme of glucose oxidase (GOD) from A. niger.

9
Intended Use
The FORA Premium V10 system kit includes:
Contents of System
Test strips, control solution, sterile lancets and lancing device may be
purchased separately. Please make sure you have those items needed
for a blood glucose test beforehand.
If you wish to transfer data from your meter to a computer (see
"Downloading Results onto your computer" p.28) , you will need to
purchase an RS232 cable, this cable is not provided in the kit. Please
contact your local customer service or place of purchase to obtain this
cable.
Meter
Owner’s Manual
Quick Start User Guide /
Warranty Card
1
2
3
4
5
6
Protective Wallet
Daily Log Book
Two AAA Batteries
NOTE:
If any items are missing from your kit or opened prior to use, or to obtain
test strips and control solution, please contact the place of purchase or call
Customer Service for assistance.
6
1 432
5

10
Meter Overview
Test Strip Slot
Insert test strip here to turn the meter on for testing.
Test Strip Ejector
Eject the used strip by sliding up this button.
Display Screen
M Button
Enter the meter memory and silence a reminder alarm.
Data Port
Download test results with a cable connection.
SET Button
Enter SET mode and confirm the meter settings.
1
2
3
5
6
4
3
4
2 2
6
1
5

11
Display Screen
Volume Symbol
Test Strip Symbol
Blood Drop Symbol
Low Battery Symbol
Test Result
Alarm Symbol
Date
1
2
3
5
4
6
Time
Control Solution Mode
Measuring Mode
Memory Symbol
Day Average
Ketone Warning
Measurement Unit
7
9
12
14
8
11
13
10
11
10
9
14
12
13
1
234
5
6
7
8

12
Test Strip
Test Strip Handle
Hold this part to
insert the test strip
into the slot.
Confirmation Window
Confirm if enough blood
has been applied to the
absorbent hole of the
strip.
Contact Bars
Insert this end of the test
strip into the test strip
slot.
Absorbent Hole
Blood will be
automatically drawn
into here.
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 Premium V10 monitor should only be used with FORA Premium
V10 Test Strips. Using other test strips with this meter can produce inaccurate
results.

13
Entering the Setting Mode
Start with the meter off (no test strip
inserted). Press SET.
1. Setting the date
With the year flashing, press until the
correct year appears. Press SET.
With the month flashing, press until
the correct month appears. Press SET.
With the day flashing, press until the
correct day appears. Press SET.
2. Setting the time
With the hour flashing, press until the
correct hour appears. Press SET.
With the minute flashing, press until
the correct minute appears. Press SET.
Setting the Meter
Before using your meter for the first time or if you change the meter
battery, you should check and update the settings. Make sure you
complete the steps below to change your settings.

14
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 SET.
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.
3. Deleting the memory
With “dEL”and “”on the display, press
and select “no”to keep the results in
memory then press SET to skip.
To delete all the results, press and
select “yes”to delete all the memory
records.

15
5. Choosing a language
Press to select L1/L2/L3.
L1: English.
L2: Spanish.
L3: Chinese.
To confirm your selection, press SET.
6. Setting the reminder alarm
Your meter has four reminder alarms.
The meter will display "OFF" , " " and
"A-1".
If you don't want to set an alarm,
press SET to skip this step. Or press
to select "On", then press SET.
With the hour flashing, press to select
the correct hour. Press SET.
With the minute flashing, press to
select the correct minute. Press SET to
confirm and go to the next alarm setting.
Congratulations! You have completed all settings!
NOTE:
• These parameters can ONLY be changed in the setting mode.
• If the meter idles for 3 minutes during the setting mode, it will switch off
automatically.

16
You can switch between the two modes by:
1. With the meter turned off, insert a test
strip to turn on the meter. The screen will
display a flashing blood drop.
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring, General, AC,
PC and QC.
MODES
General
AC
PC
QC
USE WHEN
any time of day without regard to time since last meal
no food intake for at least 8 hours
2 hours after a meal
testing with the control solution
2. Press to switch between General,
AC, PC and QC mode.

17
Control Solution Testing
Our control solutions contain a known amount of glucose that reacts with
the test strips, and is used to ensure that the meter and test strips are
working together correctly.
Test strips, control solutions, or sterile lancets may not be included in
the kit (please check the contents on your product box). They can be
purchased separately. Please make sure you have all items prior to
testing your blood glucose.
Test with a control solution when:
● you first receive the meter.
● you do your weekly routine quality testing of the meter and test strips.
● you open a new vial of test strips.
● you suspect the meter or test strips are not working correctly.
● your blood glucose test results are not consistent with how you feel, or
if you think the results are not accurate.
● you are practicing the testing procedure.
● you have dropped or think you may have damaged the meter.
Performing a Control Solution Test
1. Insert the test strip to turn on the
meter
Wait for the meter to display “”and
“”.
Voice Guide
Please relax during measurement. Please
apply blood to the strip.

18
2. Press until “QC” is displayed.
With “QC”displayed, the meter will not
store your test result in memory. If you
press again, the “QC”will disappear
and this test is no longer a control
solution test.
WARNING:
When doing the control solution test “QC”must be displayed so that the test
results will not be stored in the memory. Failure to have the meter in the correct
mode will result in having the control solution test results stored with your actual
blood glucose test results. This will cause an inaccurate analysis of your stored
results.
3. Apply control solution
Shake the control solution bottle thoroughly before use. Squeeze out a
drop onto the tip of the bottle cap and wipe it off using a clean tissue or
cloth. Then squeeze out another drop onto the tip of the bottle cap.
Hold the meter so that the strip is pointing downward and move the
absorbent hole of the test strip to touch the drop. Once the confirmation
window fills completely, the meter will begin counting down.
To avoid contaminating the control solution, do not directly apply control
solution onto a strip.

19
NOTE:
• The control solution range printed on the test strip vial is for control solution
use only. It is not a recommended range for your blood glucose level.
• See the Maintenance section for important information about your
control solutions.
Out-of-range results
If you continue to have test results fall outside the range printed on the
test strip vial, the meter and strips may not be working properly. Do NOT
test your blood using this meter. Go to www.foracare.com, or call your
customer service for help.
4. Read and compare the result
After counting down to 0, the control
solution test result will appear on the
display. Compare this result with the
range printed on the test strip vial. It
should fall within the range. If not, please
read the instructions again and repeat
the control solution test.
Voice Guide
Your blood glucose is (number) milligrams
per deciliter.
100~165
Normal

20
TESTING WITH BLOOD SAMPLE
Preparing the Lancing Device for Blood Testing
Please follow the instructions in the lancing device insert for collecting a
blood sample.
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.
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 or the lancing
device.
• Wash and dry your hands thoroughly before and 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 person who is providing testing assistance
to the user, the meter and lancing device should be decontaminated prior to
use by that person.
Preparing the Puncture Site
Rubbing the puncture site before blood extraction has a significant
influence on the accuracy of your test results.
Blood from an alternate site that has not been rubbed exhibits a
measurably different glucose concentration than blood from the finger.
When the puncture site was rubbed prior to blood extraction, the
difference was significantly reduced.