Premium V12 User manual

Owner’s Manual
Blood Glucose Monitoring System
V12
V12 Voice


3
Dear Premium V12* Series System
Owner:
Thank you for purchasing the Premium V12 Series Blood Glucose
Monitoring System. This manual provides important information to help
you to use the system properly. Before using this product, please read the
following contents thoroughly and carefully.
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 Premium V12 Series Blood Glucose
Monitoring System to easily monitor your blood glucose levels by yourself
anywhere, any time.
If you have questions, just call ForaCare Customer Care Service Center
toll-free at 1-866-469-2632. We are here for you 24 hours a day, 7 days a
week. You can also visit www.foracare.com.
* Talking function is available on the FORA Premium V12 Voice System
only. The voice output of FORA Premium V12 Voice System is available in
English and Spanish.
Version 2.0 2013/01
311-4125000-001
English
Premium V12 Voice Model Only

4
IMPORTANT SAFETY PRECAUTIONS
READ BEFORE USE
● Themeterandlancingdeviceareforsinglepatientuse.Donotsharethem
with anyone including other family members! Do not use on multiple
patients!
● Allpartsofthekitareconsideredbiohazardousandcanpotentially
transmit infectious diseases, even after you have performed cleaning and
disinfection.
For more information, please visit
1.“FDAPublicHealthNotication:UseofFingerstickDevicesonMorethanOnePerson
PosesRiskforTransmittingBloodbornePathogens:InitialCommunication”(2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
2.“CDCClinicalReminder:UseofFingerstickDevicesonMorethanOnePersonPoses
RiskforTransmittingBloodbornePathogens”(2010)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
1.UsethisdeviceONLY for the intended use described.
2. Do NOTuseaccessorieswhicharenotspeciedbythemanufacturer.
3. Do NOT use the device if it is not working properly or if it is damaged.
4. This device does NOT serve as a cure for any symptoms or diseases. The
data measured is for reference only.
5. Before using this device to test blood glucose, read all instructions
thoroughly and practice the test. Carry out all the quality control checks as
directed.
6.Useofthisdeviceinadryenvironment,especiallyifsyntheticmaterialsare
present(syntheticclothing,carpetsetc.)maycausedamagingstatic
discharges that may cause erroneous results.
7. Do NOT use this device in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

5
TABLE OF CONTENTS
BEFORE YOU BEGIN 06
Important Information 06
IntendedUse 07
Test Principle 07
Meter Overview 08
Display Screen 09
Test Strip 10
Setting the Meter 11
THE FOUR MEASURING MODES 15
Control Solution Testing 16
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 25
Reviewing Test Results 25
Reviewing Blood Glucose Day Average Results 27
Downloading Results on to 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

6
BEFORE YOU BEGIN
Important Information
● Severedehydrationandexcessivewaterlossmaycausereadings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
● Ifyourbloodglucoseresultsarelowerorhigherthannormal,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
normal, consult with your healthcare professional.
● Useonlyfreshwholebloodsamplestotestyourbloodglucose.Using
other substances will lead to incorrect results.
● Ifyouareexperiencingsymptomsthatareinconsistentwithyourblood
glucose test results and you have followed all the instructions given in
this owner’s manual, contact your healthcare professional.
● Wedonotrecommendusingthisproductonseverelyhypotensive
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.
● Criticallyillpatientsshouldnotbetestedwithabloodglucose
monitoring system.

7
Intended Use
The Premium V12 Series Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary
wholebloodfromthefingerandthefollowingalternativesites:palm,
forearm, upper-arm, calf and thigh. 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 Premium V12 Series Blood Glucose
Monitoring System can be used only during steady-state blood glucose
conditions.
Premium V12 Voice has some speaking functions but is not intended for
use by the visually impaired.
Test Principle
Yoursystemmeasurestheamountofsugar(glucose)inwholeblood.
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.

8
Meter Overview
Display Screen
Test Strip Slot
Insert test strip here to turn the meter on for testing.
Test Strip Ejector
Eject the strip by sliding the up this button
M Button
Enter the meter memory and silence a reminder alarm.
Data Port
Download test results with a cable connection.
SET Button
Enterandconrmthemetersettings.
Strip slot Indicator light
Press, release and wait for 5 seconds to see the test
lightindicatorlightup(forlowlightenvironment)
1
2
3
5
6
7
7
4
3
4
6
21
5

9
Display Screen
Volume Symbol( For
Premium V12 Voice Only)
Insert Test Strip
Test Strip Symbol
Blood Drop Symbol
Test Result
Date
Time
1
2
3
5
4
6
7
Day Average
Memory Symbol
Ketone Warning
Control solution Mode
Measurement Unit
Low Battery Symbol
8
10
13
9
12
11
2
1
34
5
10
6
9
11 8
12
13
7

10
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
Touch to a drop of
blood here, blood will
be automatically
drawn in.
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 Premium V12 Series Blood Glucose Monitoring System should only be used
with Premium V12 SeriesTestStrips.Usingotherteststripswiththismetercan
produce inaccurate results.

11
1. Setting the date
With the year flashing, press M Button
until the correct year appears. Press SET
Button.
With the month flashing, press M Button
until the correct month appears. Press
SET Button.
With the day flashing, press M Button
until the correct day appears. Press SET
Button.
2. Setting the time
With the hour flashing, press M Button
until the correct hour appears. Press SET
Button.
With the minute flashing, press M Button
until the correct minute appears. Press
SET Button.
Setting the Meter
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
Startwiththemeteroff(noteststrip
inserted).Press SET.

12
Premium V12 Voice model enters STEP 4 and STEP 5 for speaking
volume setting and language setting mode; for Premium V12 model
please go to STEP 6 directly.
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 “ ”willbedisplayedthroughoutthetesting.
4. Setting the speaking volume (For
Premium V12 Voice only)
Thereareseven(7)speakingvolume
options to choose from. Press M Button
until the desired speaking volume
appears. To confirm your selection, press
SET Button.
3. Deleting the memory
With“yes/no”flashingand“dEL”and
“ ”symbolonthedisplay,pressM
Button to switch decision.
If you would not delete the memory, press
SETButtonwhenflashing“no”ondisplay.
Whenflashing“yes”ondisplay,pressSET
Button to delete all internal records.
LCDwilldisplay“---“and“OK”afterall
records are deleted, press SET Button to
continue the settings.

13
5. Choosing a Language (For Premium
V12 Voice only)
PresstheMButtontoselectL1/L2.
The default language for the meter is
L1,whichisEnglish.Toconfirmyour
selection, press SET Button.
6. Setting the Reminder Alarm
You may set up any or all of the reminder
alarms(1-4).Themeterdisplays“On”or
“OFF”and , press M Button to switch
“On”or“OFF”.PressSETButtontoset
the first reminder alarm.
Press M Button to increase hour, then
press SET Button to set the hour.
Press M Button to increase minute, then
press SET Button to set the minute and
confirm.
Go to the next alarm setting.
At the time of your alarm, the meter will
beep and automatically turn on. You can
press M Button to silence the alarm or
insert a test strip to begin testing.
If you want to turn off an alarm, find the alarm number by pressing SET
Buttoninthesettingmode,pressMButtontochangefrom“On’to“OFF”.
If you do not press M Button, the meter will beep for 2 minutes then
switch off automatically. If you do not want to test at this time, press M
Button to switch off the meter.
Congratulations! You have completed all settings!

14
NOTE:
•TheseparameterscanONLYbechangedinthesettingmode.
•Ifthemeterisidlefor3minutesduringthesettingmode,itwillswitchoff
automatically.

15
Youcanswitchbetweeneachmodeby:
1. Start with the meter switched 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
2. Press M Button to switch between
General, AC, PC and QC mode
Modes Use when
General tests any time of day without regard to time since last meal
AC no food intake for at least 8 hours
PC 2 hours after a meal
QC testing with the control solution

16
Control Solution Testing
Our control solutions contain a known amount of glucose that reacts
with 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
thekit(pleasecheckthecontentsonyourproductbox).Theycanbe
purchased separately. Please make sure you have all items prior to
testing your blood glucose.
Test with a control solution when:
● youfirstreceivethemeter,
● youfirstreceivethemeter.
● youdoyourweeklyroutinequalitytestingofthemeterandteststrips.
● youbeginusinganewvialofteststrips.
● yoususpectthemeterandorteststripsarenotworkingcorrectly.
● yourbloodglucosetestresultsarenotconsistentwithhowyoufeel,or
if you think the results are not accurate.
● youarepracticingthetestingprocedure.
● youhavedroppedorthinkyoumayhavedamagedthemeter.

17
WARNING:
When doing the control solution test, you have to mark it so that the test result
will not be stored in the memory. Failure to do so will mix up the blood glucose
test results with the control solution test results in memory.
Performing a Control Solution Test
Premium V12 Voice model only.
Voice Guide:
" Please apply blood onto the test strip."
2. Press M Button to mark this test as a
control solution test
With“QC”displayed,themeterwillnot
store your test result in memory. If you
presstheMButtonagain,the“QC”will
disappear and this test is no longer a
control solution test.
1. Insert the test strip to turn on the
meter
Wait for the meter to display “ ”and
“ ”.

18
100~165
Normal
3. Apply control solution
Shake the control solution vial thoroughly before use.
Squeeze out a drop and wipe it off, then squeeze out another drop and
place it on the tip of the vial cap.
Hold the meter to 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.
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 and it
should fall within this range. If not, please
read the instructions again and repeat
the control solution test.
"Thebloodglucoseis(number)
milligrams per deciliter. "
Premium V12 Voice model only.
Voice Guide:

19
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. Contact the local customer service or place of purchase
for help.
NOTE:
•Thecontrolsolutionrangeprintedontheteststripvialisforcontrolsolution
use only. It is not a recommended range for your blood glucose level.
•SeetheMeterMaintenancesectionforimportantinformationaboutyour
control solutions.

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:
Toreducethechanceofinfection:
•Neversharealancetorthelancingdevice.
•Alwaysuseanew,sterilelancet.Lancetsareforsingleuseonly.
•Avoidgettinghandlotion,oils,dirt,ordebrisinoronthelancetsorthelancing
device.
•Washanddryyourhandsthoroughlybeforeandafterhandlingthemeter,
lancing device and test strips to prevent infection. For more information,
pleaserefertothe“CleaningandDisinfection”section.
•Ifthemeterisbeingoperatedbyapersonwhoisprovidingtestingassistance
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 a 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.
Table of contents
Languages: