Arkray Glucocard Vital Operator's manual

User
Instruction
Manual

INTRODUCTION ....................................5
Intended Use ....................................5
Important Information.............................6
The GLUCOCARD®Vital™ System...................7
GETTING TO KNOW THE GLUCOCARD®VITAL™ SYSTEM....8
METER SET UP....................................10
Setting the Time and Date .......................10
DISPLAY SCREEN MESSAGES .......................14
METER MEMORY .................................19
Marking Results in the Memory ....................19
Recalling Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
CARING FOR YOUR GLUCOCARD®VITAL™ METER.....24
Cleaning the Meter ..............................24
Storage ........................................24
Changing the Battery ............................25
THE LANCING DEVICE ............................27
Inserting a Lancet ...............................27
Obtaining a Drop of Blood .......................29
3
TABLE OF CONTENTS
CAUTION:
Before using any product to test your blood sugar
(blood glucose), read all instructions and practice
the test. Do all quality control checks as directed
and consult with a diabetes healthcare professional.
These recommendations apply to all blood glucose
monitoring systems and are supported by the
American Association of Diabetes Educators, the
American Diabetes Association, the U.S. Food
and Drug Administration, and the Health Industry
Manufacturers Association.

TESTING WITH GLUCOCARD®VITAL™ TEST STRIPS . . . . . . . .31
Important Test Strip Information . . . . . . . . . . . . . . . . . . . .31
GLUCOCARD®Vital™ Test Strips . . . . . . . . . . . . . . . . . . .32
PERFORMING A BLOOD GLUCOSE TEST ...............33
ALTERNATE SITE TESTING (AST) . . . . . . . . . . . . . . . . . . . . . .37
Important Information About
Alternate Site Testing (AST) .....................37
Preparing to Test your Blood Glucose
From an Alternate Site.........................38
Performing a blood glucose test
From an Alternate Site.........................39
USING ASSURE®DOSE CONTROL SOLUTION . . . . . . . . . .43
Performing a Control Solution Test . . . . . . . . . . . . . . . . . .45
Comparing Control Solution Results .................48
Comparing Meter and Laboratory Results . . . . . . . . . . .49
UNDERSTANDING TEST RESULTS ......................50
Expected blood glucose readings . . . . . . . . . . . . . . . . 51
High blood glucose readings..................... 51
Low blood glucose readings ..................... 52
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
WARNINGS, PRECAUTIONS, & LIMITATIONS..............55
WARRANTY ...................................... 56
Thank you for choosing the GLUCOCARD®Vital™ Blood
Glucose Monitoring System. Frequent blood glucose
testing is important. It tells you how your diabetes is
affected by factors such as medication, diet, exercise,
and stress management. Blood glucose test results can
also tell you if your diabetes is changing in ways that
affect your treatment plan. Always consult your diabetes
healthcare professional before making any changes.
All of the information needed to use the GLUCOCARD®
Vital™ System is included in this manual. Please read it
thoroughly before using the system. If you have any
questions, call ARKRAY’s Customer Service at 800.566.8558
(24 hours a day, 7 days a week, USA and Canada only).
Contact your healthcare professional with questions if you
are unable to reach Customer Service.
Intended Use
The GLUCOCARD®Vital™ Blood Glucose Monitoring
System is intended for the quantitative measurement of
glucose in fresh capillary whole blood samples drawn from
the fingertips or palm. Testing is done outside the body
(
In Vitro Diagnostic Use). It is indicated for use at home
(over the counter [OTC]) by persons with diabetes, or in
clinical settings by healthcare professionals, as an aid
to monitor the effectiveness of diabetes control. It is not
intended for the diagnosis of or screening for Diabetes
Mellitus, and is not intended for use on neonates.
54
INTRODUCTION

76
Important Information
• Test results below 70 mg/dL indicate low blood glucose
(hypoglycemia)
• Test results above 240 mg/dL indicate high blood
glucose (hyperglycemia)
• If results are below 70 mg/dL or above 240 mg/dL,
repeat the test
• If results continue to measure below 70 mg/dL or
above 240 mg/dL consult your diabetes healthcare
professional immediately
• If symptoms are not consistent with test results AND all
the instructions have been followed carefully, contact
your diabetes healthcare professional
• Before testing, always make sure both the meter and
test strips are at operating temperature
The GLUCOCARD®Vital™ System Includes:
• GLUCOCARD®Vital™ Meter
• Carrying Case
• User Instruction Manual
• Self-testing Logbook
• May include Test Strips, Control Solution, and Lancing
Device and/or Lancets

98
Front
Back
The GLUCOCARD®Vital™ Meter
Display Screen
Back Button
On/Off Button
Forward Button
Battery Compartment
Cover
Test Strip Port
Explanation of the Full Display Screen
Time
Date
Average Test
Reading
Control
Solution Test
Low
Battery
Unit of
Measurement
Temperature
Warning
Test Strip
Apply Blood
Insert/Remove
Test Strip
Memory Mode
Error Code
Result Warning
Main Display:
Test Strip Code
Test Countdown
Test Results
Error Codes
If any part of the display screen is missing when the meter
is turned on call Customer Service at 800.566.8558.
GETTING TO KNOW THE GLUCOCARD®VITAL™
BLOOD GLUCOSE METER

1110
Meter Set Up
Before using the GLUCOCARD®Vital™ Meter for the first
time, you must set the time and date. You can choose
between the 12-hour format (1-12 o’clock with am or pm)
and the Military 24-hour format (0-23). The date format
can either be displayed as month/day (U.S.A. format) or
day/month (International format). Do not perform a blood
glucose test until you have set the meter correctly.
Setting the Time and Date
Step 1 – Turn on meter
Press the On/Off button to turn the meter on. The full
screen appears briefly. If any part of the display screen
is missing (see page 9), call Customer Service. The meter
then displays the time, date, unit of measurement, and
the insert strip symbol.
Step 2 – Enter set-up mode
Press and hold down the On/Off button for more than
2 seconds to enter the set-up mode.
Step 3 – Set the time format
The time can be displayed in either 24-hour format or
12-hour format with AM and PM. The meter displays the
current time format. To change format, press either the
Back or Forward button. Press the On/Off button to select
the time format. The date format then appears on the
display.
Step 4 – Set the date format
The date format can either be displayed as month/day
(01/31) or day/month (31/01). The meter displays the
current format. To change format, press either the Back or
Forward button. Press the On/Off button to select the date
format. The hour setting then flashes on the display.
Month/Day
Format
Day/Month
Format

1312
Step 5 – Set the hour
Press and release the Back or
Forward buttons to change the hour.
Hold the Back or Forward button down
to scroll through quickly. When the
correct hour is displayed, press the
On/Off button. The minute setting then
flashes on the display.
Step 6 – Set the minute
Press and release the Back or Forward
buttons until the correct minute
appears. Hold the Back or Forward
button down to scroll through quickly.
When the correct minute is
displayed, press the On/Off button.
The month setting then flashes on the
display.
Step 7 – Set the month
(If day/month format is selected then
Step 7 will set day)
Press and release the Back or Forward
buttons until the correct month
appears. Hold the Back or Forward
button down to scroll through quickly.
When the correct month is displayed,
press the On/Off button. The day
setting then flashes on the display.
Step 8 – Set the day
(If day/month format is selected then
Step 8 will set month)
Press and release the Back or
Forward buttons until the correct day
appears. Hold the Back or Forward
button down to scroll through quickly.
When the correct day is displayed,
press the On/Off button. The year
setting then flashes on the display.
Step 9 – Set the year
Press and release the Back or
Forward buttons until the correct
year appears. Hold the Back or
Forward button down to scroll through
quickly. When the correct year is
displayed, press the On/Off button
for two seconds to exit set up mode.
Note:
Pressing the On/Off button for more than 2 seconds at
any stage saves the time and date and exits the set-up
mode. The meter automatically shuts off after 2 minutes
if no buttons are pressed. Settings stored up to that point
are saved.
Hour flashing
Minute flashing
Month flashing
Day flashing
Year flashing

1514
Display Screen Messages
A list of all display screen messages is included below.
If you have any questions after reading these messages,
or if the meter displays a message not listed here, call
Customer Service at 800.566.8558 (24 hours a day, 7 days
a week, USA and Canada only). If the display screen
shows , you should be able to clear the error message
yourself. Do not send your meter to ARKRAY or your local
dealer without authorization from a company
representative.
Your blood glucose level is less
than 20 mg/dL. Repeat the test
using a new test strip. If this
message appears again, contact
your healthcare professional
immediately.
Your blood glucose level is more
than 600 mg/dL. Repeat the test
using a new test strip. If this
message appears again, contact
your healthcare professional
immediately.
The battery has been replaced.
Check that the time and date are
set correctly.
A used strip has been inserted
or the meter is having difficulty
reading the strip.
Repeat the test with a new
test strip.
The battery power is getting low.
There is enough power for
approximately 100 tests before the
battery needs to be replaced.

1716
The battery power is low.
There is only enough power for
about 20 more tests. Replace with
a new CR2032 battery as soon as
possible.
The battery power is too
low for testing.
Replace with a new
CR2032 battery.
Thermometer flashing.
The meter and test strips are
outside the optimum temperature
range of 50°F - 104°F (10°C - 40°C).
Make sure your meter and
strips are in an environment
with a temperature between
50°F - 104°F (10°C - 40°C).
Treat test result obtained where
the thermometer is flashing with
caution. The flashing thermometer
will be displayed on all screens
during glucose testing until the
meter has reached acceptable
temperature. Readings obtained
with the flashing thermometer will
show a thermometer when results
are recalled in memory.
Thermometer symbol - E6.
Temperature outside of
acceptable range of 41°F - 113°F
(5°C - 45°C). You will not obtain a
reading. Allow the meter and strips
to warm up or cool down slowly to
between 50°F - 104°F (10°C - 40°C)
or at least to 41°F - 113°F
(5°C - 45°C).

1918
Corrupted memory.
Call Customer Service at
800.566.8558.
Meter Memory
Marking Results in the Memory
You can mark results in the meter memory in two ways.
Marking Control Solution Tests
You must mark results with the control bottle symbol .
Insert test strip into the meter. Hold the Back or Forward
button until appears in the upper right corner of the
screen. Do this BEFORE performing a control solution
test. If you do not mark control solution tests before
applying control solution to the test strip, the results
may not be accurate and control solution test results
will be included in your test result averages.
The meter does not use results marked when it
calculates the 14- and 30-day average. This ensures that
your 14- and 30-day average includes only results from
testing your own blood.
Not enough blood was
added to test strip.
Retest with new test strip. Apply
at least 0.5µL of blood to sample
application tip.

2120
To mark a result , press the Back or Forward button
BEFORE testing with control solution. (See page 43 for
detailed instructions on testing with control solution).
Marking Other Results
You can also mark results with an when you do NOT want
to include the result in your 14- and 30-day average. For
example, if someone else used your meter, or if you believe the
test result is incorrect because you applied blood to the test
strip incorrectly, use the exclamation mark to ensure that your
14- and 30-day average includes only those results from testing
your own blood that you want included in your average. To
mark a result with , press the Back or Forward button AFTER
the meter displays the test result.
Recalling Results
Step 1
Press the On/Off button to turn on the
meter. Then press the
Back or Forward
button. Do not insert
a test strip to turn on
the meter.
<
<
Step 2
Press the Back or Forward
button to display the average
of tests over the last 14 days.
This can include 1 to 250 results,
depending on how frequently
you test. The number at the top
(20n) shows the number of tests
that have produced the average.
is displayed when the
average is shown.
Step 3
Press the Back or Forward button
again to display the 30-day
average. The greater the frequency
of testing the higher this number
will be.
is displayed when the
average is shown.
If no results are stored, or you are
using the meter for the first time, the
meter will display 3 bars.
Displaying the average
(14 day)
Displaying the aver-
age (30 day)
No results stored
<
<
mg/dL
is displayed when the memory mode is
entered. The meter displays the most
recent test result stored in the
memory.

2322
<
<
If a test has not been performed
in the last 14 days the meter
will display the 14-day average
screen with 3 bars. This means
there are no results stored to
produce the average. If a test has
not been performed in the last 30
days the meter will display the
30-day average screen with 3
bars.
Step 4
Press the Back and Forward
buttons to recall other results
stored in the memory. Pressing
the Forward button after the
average displays the oldest test
in memory. Pressing the Back
button after the average displays
the second most recent test in
memory.
The meter displays the time each
test was recorded in the upper
left corner. The date of the test
appears below the time.
Results marked with when the test
was performed are not included in
the average. The marked results can
be seen when you scroll through the
results saved in the memory.
The memory mode also displays
if the result was marked before using
control solution. These results are
not included in the 14- and 30-day
average.
If the thermometer symbol is
flashing when you perform a test,
the thermometer symbol will be
displayed in the memory with the
result. These results will not be
included in the meter averages.
NOTE:
Results that appear as LO are included as 20 mg/dL
in the glucose averages. Results that appear HI are
included as 600 mg/dL in the glucose averages.
Step 5
Press the On/Off button to return to the user mode. If
you are not going to test, press the On/Off button again
to shut off the meter.

2524
Caring for Your GLUCOCARD®Vital™ Blood
Glucose Meter
Cleaning the Meter
The GLUCOCARD®Vital™ Blood Glucose Meter is a precise
instrument. Please handle it with care. Clean the outside of
the meter with a damp cloth only. Dirt, dust, blood, control
solution, or water entering the meter could cause damage.
Your GLUCOCARD®Vital™ Blood Glucose Meter should
not need decontamination as no blood or control solution
should come into contact with the meter if the instructions
are followed correctly.
Storage
The GLUCOCARD®Vital™ Blood Glucose Meter is
designed to be stored within a 32°F - 122°F (0°C - 50°C)
temperature range.
• Donotleaveyourmeterinextremelyhotorcoldplaces
such as near a heat source (radiator) or in a car in very
hot or cold weather
• Do not store or use your meter or test strips where they
may be exposed to high humidity, such as in a
bathroom or kitchen
• Never hold the meter or test strips under running water
• Do not use or store your meter on or near a strong
electro-magnetic field such as a microwave oven,
stereo amplifiers, or a mobile phone
• Do not store your meter or test strips near bleach or
cleaners that contain bleach
Note:
Changing the battery should only take a few seconds.
If the battery is changed within 30 seconds, the meter
memory is not affected. You will not lose any past test
results and the settings are not affected.
However, if it takes longer than 30 seconds to change
the battery, or if the battery is dead before changing
it, the time and date settings may need to be reset.
The first time the meter is turned on after changing the
battery, you may see a display screen message (E00).
This means you should check that the time and date
are correct. (See pages 10-13 for detailed instructions
on changing the time and date).
The GLUCOCARD®Vital™ Blood Glucose Meter
has a CR2032 battery installed.
When the battery power is getting low,
your meter shows . You have enough
power for about 100 tests before you need
to replace the battery.
If the is flashing, there is only enough power for about 20
tests. Replace the battery as soon as possible.
When the battery has run out, the meter will not work.
CR 2032
Li-Mn 3V
+
Changing the Battery

2726
How to Change the Battery
Step 1
Turn the meter off.
The battery cover is on the back of the meter.
Step 2
Pull the battery cover up with your finger or fingernail.
Remove battery cover.
Step 3
Remove the old battery.
If necessary, turn the meter over and tap it gently against
the palm of your hand until the battery falls out. Avoid the
use of sharp objects that may damage the meter.
Step 4
Insert the new battery.
The “+” on the battery should be facing up.
Step 5
Replace the battery cover.
NOTE: Do not use the lancet if the cap is missing or damaged.
Multilet (lancet)
Disposal-and-set
lever
Removable cap
Multi-Lancet Device™body
Lancing Button Adjustment dial
Band hooks
Strap hole
Special band
Protective cap
Groove of special band
Inserting a Lancet
Step 1: Pull the removable
cap to remove it.
Step 2: Insert a new, unused
lancet into the Holder until it
stops.
Holder
Blood Glucose Testing
The Lancing Device

2928
Step 3: Twist off the
protective cap.
Step 5: The Multi-Lancet Device offers 7 different levels
of skin penetration. For soft or thin skin or first time use,
select “1 or 2.” If the obtained amount of blood is
excessive, turn the dial to a lower setting. If the
obtained amount of blood is insufficient, turn the
dial to a larger setting.
1 2 3 4 5 6 7
Deeper
Level indications
Step 4: Press the removable cap to
the side of the fingertip. Press the
lancing device button.
Obtaining a Drop of Blood
Step 1: Wash hands with soap and
warm water. Dry hands thoroughly. If
you use alcohol wipes to cleanse
fingers, make sure the area is dry
before lancing finger. Residual alcohol
may lead to inaccurate readings.
Step 2: Let the arm hang down for 10
to 15 seconds. (Holding the arm below
the heart and massaging the wrist,
palm and finger makes it easier to
obtain a blood drop).
Step 3: Choose a site on the side of a
fingertip to minimize pain.
Step 4: Attach the
removable cap.
Step 5: Set aside the lancing device and wait a few
seconds for a blood drop to form. Keeping the hand
warm, lowering the hand to waist level and gently
massaging your wrist, palm or the base of the finger helps
the flow of blood. Use a different site each time you test
to help prevent soreness and calluses.

31
30
Note: A lancet should only be used once. After use,
put the protective cap back on and dispose in a safe
manner to avoid accidental lancet stick injuries.
Important Test Strip Information
• Storetheteststripbottleinacool,dryplace
between 39°F–86°F (4°C–30°C)
• Keep away from direct sunlight and heat
• Do not refrigerate or freeze
• Do not store or transfer the test strips outside the
original bottle
• As soon as you have removed a test strip, replace
the cap securely on the bottle
• Use test strips within 90 days (3 months) of opening
and not beyond the expiration date ( )
• Write the date of opening on the bottle label to
remind you to discard the strips after 90 days
(3 months)
• Do not bend, cut, or alter a test strip
• Do not reuse a test strip
• Use only GLUCOCARD®Vital™ Test Strips with the
GLUCOCARD®Vital™ Meter
• Ensure your hands are clean and dry before
handling test strips
The GLUCOCARD®Vital™ Blood Glucose Monitoring
System works with the GLUCOCARD®Vital™ Test Strips.
WARNING: DO NOT share used lancets with another
person. To prevent possible infection, a used lancet
should not be touched by another person.
TESTING WITH GLUCOCARD®VITAL™
TEST STRIPS

3332
GLUCOCARD®Vital™ Test Strips
These capillary action test strips require only 0.5 µl of blood
and provide an end-fill sample application tip for easy
blood application. The GLUCOCARD®Vital™ Blood
Glucose Monitoring System measures the amount of
glucose (sugar) in fresh capillary whole blood. When a
drop of blood is added to the sample application tip,
the sample is drawn into the test strip reaction site. The
glucose in the blood reacts with the enzyme on the test
strip. This reaction produces a current, proportional to the
amount of glucose in the blood. The meter detects the
current and converts it into a blood glucose reading.
Insert into meter
this way
The GLUCOCARD®Vital™ Test Strip
Note: For Instructions on Alternate Site Testing, refer
to pages 37-43.
Step 1
Insert a GLUCOCARD®Vital™
Test Strip into the meter. Insert
the contact bars into the test
strip port, with the reaction site
facing up.
<
<
Performing a Blood Glucose Test
Sample Application Tip
(apply blood sample to tip,
blood will be drawn to
reaction site)
Reaction Site
Contact Bars
Test Strip Port
When the strip is inserted, the meter
turns on automatically. If any part
of the display screen is missing (see
page 9), call Customer Service.
Reaction
Site
Test Strip
Contact Bars
Sample Application Tip
(apply blood to end of test
strip and capillary draw will pull
blood to reaction site quickly
and easily)

<
<
3534
The strip and flashing blood drop
tells you the meter is ready for
you to apply a drop of blood to
the sample application tip at the
end of the test strip.
‘Apply Blood’
symbol flashing
Step 2
Lance your finger using the
Lancing Device. Touch the sample
application tip at the end of the strip
at a 90 degree angle to the blood
drop on your finger. The capillary
action will pull the blood to the
reaction site.
IMPORTANT: The minimum sample volume is 0.5 µL.
Smaller samples may not start the meter or can start
the meter count down and provide an “E13” error
message. Ensure blood completely fills reaction site.
Enough
Blood
Not
Enough
Blood
Too
Much
Blood
DO NOT add blood to
the top of the strip.
You may receive an
abnormal (high) result.
CORRECT
INCORRECT
IMPORTANT: The meter will start to count down when
it detects that blood has been applied. Discard strip if
meter does not start to count down after blood drop
is applied.
Displaying the Result
The meter will count down. The
result is displayed in 7 seconds.

3736
Step 3
Always record your results in your self-testing logbook
along with other information such as insulin dosage,
diet, and exercise. The result is automatically stored in
memory with the time and date.
Step 4
Remove the used test strip and dispose of it carefully.
The meter shuts off automatically when the test strip is
removed.
Alternate Site Testing (AST)
Important Information About AST
Sites other than your fingertip may have fewer nerve
endings so obtaining a blood sample from these sites may
be less painful. The technique for alternate site testing is
different from fingertip testing. Blood glucose results from
sites other than your fingertip could be significantly
different due to blood glucose levels changing rapidly
after a meal, insulin, or exercise.
Consult with your diabetes healthcare professional prior to
testing from a site other than your fingertips.
Results obtained from sites other than the fingertip may
differ significantly as is the case with all blood glucose
monitoring systems. Rapidly changing results are likely to
occur after eating. Insulin dosing and physical activity are
shown in the fingertip more quickly than in alternate sites.
On average, blood taken from the palm may give results
as much as 5% higher than blood taken from the fingertip.
Consider Alternate Site Testing When:
•Testingbeforeameal
•Youareinafastingstate
•Twohourshavepassedsinceameal
•Twohourshavepassedsinceinsulindosing
•Twohourshavepassedsincephysicalactivity

<
<
3938
Use Fingertip When Testing:
•Withintwohoursafterameal
•Withintwohoursafterinsulindosing
•Withintwohoursafterphysicalactivity
•Ifyouhaveahistoryofhypoglycemia,are
experiencing low blood sugar, or suffer from
hypoglycemic unawareness (you cannot tell
when you have low blood glucose)
•ToconrmyourbloodglucoselevelifyourAST
result is not consistent with how you feel
•Duringtimesofstressorillness
Ask your diabetes healthcare professional about
recommended testing procedures before operating
machinery or driving a car, as fingertip testing is usually the
preferred method of testing under these circumstances.
If bruising occurs, you may choose to lance a fingertip
instead.
Preparing to Test Your Blood Glucose
From an Alternate Site
Choose a Site: Select a soft, fleshy area on the palm that
is free of visible veins and moles and away from bone.
Wash the area with warm, soapy water.
Rinse and dry completely. If you use
alcohol wipes to cleanse the site, make
sure the area is dry before lancing the
site.
Prepare Your Lancing Device: To order an AST Lancing Kit
containing the lancing device, lancets, and instructions,
please call 800.566.8558.
Performing a Blood Glucose Test
From an Alternate Site
Step 1
Insert lancet
and cock
lancing device.
Sample
Application Tip
(apply blood sample
to tip, blood will be
drawn to reaction site)
Reaction Site
Contact Bars
Test Strip Port
Step 2
a) Insert a test strip into the
meter. Insert contact bars
into test strip port with
reaction site facing up.
When the strip is inserted,
the meter turns on
automatically. Make sure
all symbols appear on the
screen (see page 9).
Insert into meter
this way
IMPORTANT!