Arkray-Glucocard-Vital-Manual
Arkray-Glucocard-Vital-Manual
Arkray-Glucocard-Vital-Manual
Instruction
Manual
TABLE OF CONTENTS
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Important Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
The GLUCOCARD® Vital™ System. . . . . . . . . . . . . . . . . . . . 7
CAUTION:
Before using any product to test your blood sugar GETTING TO KNOW THE GLUCOCARD® VITAL™ SYSTEM. . . . 8
(blood glucose), read all instructions and practice
METER SET UP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
the test. Do all quality control checks as directed
and consult with a diabetes healthcare professional. Setting the Time and Date . . . . . . . . . . . . . . . . . . . . . . . . 10
These recommendations apply to all blood glucose
DISPLAY SCREEN MESSAGES . . . . . . . . . . . . . . . . . . . . . . . . 14
monitoring systems and are supported by the
American Association of Diabetes Educators, the METER MEMORY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
American Diabetes Association, the U.S. Food
Marking Results in the Memory . . . . . . . . . . . . . . . . . . . . . 19
and Drug Administration, and the Health Industry
Manufacturers Association. 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
TESTING WITH GLUCOCARD® VITAL™ TEST STRIPS . . . . . . . .31
INTRODUCTION
Important Test Strip Information . . . . . . . . . . . . . . . . . . . .31
GLUCOCARD® Vital™ Test Strips . . . . . . . . . . . . . . . . . . .32 Thank you for choosing the GLUCOCARD® Vital™ Blood
PERFORMING A BLOOD GLUCOSE TEST . . . . . . . . . . . . . . 33 Glucose Monitoring System. Frequent blood glucose
testing is important. It tells you how your diabetes is
ALTERNATE SITE TESTING (AST) . . . . . . . . . . . . . . . . . . . . . .37
affected by factors such as medication, diet, exercise,
Important Information About and stress management. Blood glucose test results can
Alternate Site Testing (AST) . . . . . . . . . . . . . . . . . . . . 37 also tell you if your diabetes is changing in ways that
affect your treatment plan. Always consult your diabetes
Preparing to Test your Blood Glucose
healthcare professional before making any changes.
From an Alternate Site . . . . . . . . . . . . . . . . . . . . . . . . 38 All of the information needed to use the GLUCOCARD®
Performing a blood glucose test Vital™ System is included in this manual. Please read it
thoroughly before using the system. If you have any
From an Alternate Site . . . . . . . . . . . . . . . . . . . . . . . . 39
questions, call ARKRAY’s Customer Service at 800.566.8558
USING ASSURE® DOSE CONTROL SOLUTION . . . . . . . . . .43 (24 hours a day, 7 days a week, USA and Canada only).
Performing a Control Solution Test . . . . . . . . . . . . . . . . . .45 Contact your healthcare professional with questions if you
are unable to reach Customer Service.
Comparing Control Solution Results . . . . . . . . . . . . . . . . 48
Comparing Meter and Laboratory Results . . . . . . . . . . .49 Intended Use
UNDERSTANDING TEST RESULTS . . . . . . . . . . . . . . . . . . . . . 50
Expected blood glucose readings . . . . . . . . . . . . . . . . 51 The GLUCOCARD® Vital™ Blood Glucose Monitoring
High blood glucose readings . . . . . . . . . . . . . . . . . . . . . 51 System is intended for the quantitative measurement of
glucose in fresh capillary whole blood samples drawn from
Low blood glucose readings . . . . . . . . . . . . . . . . . . . . . 52
the fingertips or palm. Testing is done outside the body
(In Vitro Diagnostic Use). It is indicated for use at home
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54 (over the counter [OTC]) by persons with diabetes, or in
clinical settings by healthcare professionals, as an aid
WARNINGS, PRECAUTIONS, & LIMITATIONS . . . . . . . . . . . . . 55 to monitor the effectiveness of diabetes control. It is not
WARRANTY. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56 intended for the diagnosis of or screening for Diabetes
Mellitus, and is not intended for use on neonates.
4 5
Important Information The GLUCOCARD® Vital™ System Includes:
• Test results below 70 mg/dL indicate low blood glucose • GLUCOCARD® Vital™ Meter
(hypoglycemia)
• Carrying Case
• Test results above 240 mg/dL indicate high blood
glucose (hyperglycemia) • User Instruction Manual
6 7
GETTING TO KNOW THE GLUCOCARD® VITAL™
BLOOD GLUCOSE METER
Front
Control Low
Solution Test Battery
Display Screen
Time
Memory Mode
Date
Back Button Unit of
On/Off Button Average Test Measurement
Reading
Forward Button
8 9
Meter Set Up Step 3 – Set the time format
The time can be displayed in either 24-hour format or
Before using the GLUCOCARD® Vital™ Meter for the first 12-hour format with AM and PM. The meter displays the
time, you must set the time and date. You can choose current time format. To change format, press either the
between the 12-hour format (1-12 o’clock with am or pm) Back or Forward button. Press the On/Off button to select
and the Military 24-hour format (0-23). The date format the time format. The date format then appears on the
can either be displayed as month/day (U.S.A. format) or display.
day/month (International format). Do not perform a blood
glucose test until you have set the meter correctly.
Month/Day Day/Month
Format Format
10 11
Step 5 – Set the hour Step 8 – Set the day
Press and release the Back or (If day/month format is selected then
Forward buttons to change the hour. Step 8 will set month)
Hold the Back or Forward button down Press and release the Back or
to scroll through quickly. When the Forward buttons until the correct day
correct hour is displayed, press the appears. Hold the Back or Forward
On/Off button. The minute setting then button down to scroll through quickly.
flashes on the display. Hour flashing When the correct day is displayed, Day flashing
press the On/Off button. The year
Step 6 – Set the minute setting then flashes on the display.
Press and release the Back or Forward
buttons until the correct minute Step 9 – Set the year
appears. Hold the Back or Forward Press and release the Back or
button down to scroll through quickly. Forward buttons until the correct
When the correct minute is year appears. Hold the Back or
displayed, press the On/Off button. Forward button down to scroll through
The month setting then flashes on the quickly. When the correct year is
display. Minute flashing
displayed, press the On/Off button Year flashing
for two seconds to exit set up mode.
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.
Note:
When the correct month is displayed,
Pressing the On/Off button for more than 2 seconds at
press the On/Off button. The day
any stage saves the time and date and exits the set-up
setting then flashes on the display. Month flashing
mode. The meter automatically shuts off after 2 minutes
if no buttons are pressed. Settings stored up to that point
are saved.
12 13
Display Screen Messages The battery has been replaced.
Check that the time and date are
A list of all display screen messages is included below. set correctly.
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.
A used strip has been inserted
or the meter is having difficulty
reading the strip.
Your blood glucose level is less Repeat the test with a new
than 20 mg/dL. Repeat the test test strip.
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 The battery power is getting low.
using a new test strip. If this There is enough power for
message appears again, contact approximately 100 tests before the
your healthcare professional battery needs to be replaced.
immediately.
14 15
The battery power is low. Thermometer flashing.
There is only enough power for The meter and test strips are
about 20 more tests. Replace with outside the optimum temperature
a new CR2032 battery as soon as range of 50°F - 104°F (10°C - 40°C).
possible. 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
The battery power is too caution. The flashing thermometer
low for testing. will be displayed on all screens
Replace with a new during glucose testing until the
CR2032 battery. meter has reached acceptable
temperature. Readings obtained
with the flashing thermometer will
show a thermometer when results
are recalled in memory.
16 17
Corrupted memory. Meter Memory
Call Customer Service at
800.566.8558. Marking Results in the Memory
You can mark results in the meter memory in two ways.
18 19
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).
Step 2
Marking Other Results Press the Back or Forward
You can also mark results with an when you do NOT want button to display the average
to include the result in your 14- and 30-day average. For of tests over the last 14 days.
example, if someone else used your meter, or if you believe the This can include 1 to 250 results,
test result is incorrect because you applied blood to the test depending on how frequently Displaying the average
strip incorrectly, use the exclamation mark to ensure that your you test. The number at the top (14 day)
14- and 30-day average includes only those results from testing (20n) shows the number of tests
your own blood that you want included in your average. To that have produced the average.
mark a result with , press the Back or Forward button AFTER
the meter displays the test result. is displayed when the
average is shown.
20 21
If a test has not been performed Results marked with when the test
in the last 14 days the meter was performed are not included in
will display the 14-day average the average. The marked results can
screen with 3 bars. This means be seen when you scroll through the
there are no results stored to results saved in the memory.
produce the average. If a test has
The memory mode also displays
not been performed in the last 30
if the result was marked before using
days the meter will display the
control solution. These results are
30-day average screen with 3
not included in the 14- and 30-day
bars.
average.
If the thermometer symbol is
Step 4 flashing when you perform a test,
Press the Back and Forward the thermometer symbol will be
buttons to recall other results displayed in the memory with the
stored in the memory. Pressing result. These results will not be
the Forward button after the included in the meter averages.
average displays the oldest test
in memory. Pressing the Back < <
button after the average displays
the second most recent test in
memory. 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.
The meter displays the time each
test was recorded in the upper
left corner. The date of the test Step 5
appears below the time. 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.
22 23
Caring for Your GLUCOCARD® Vital™ Blood Changing the Battery
Glucose Meter
Note:
Cleaning the Meter Changing the battery should only take a few seconds.
The GLUCOCARD® Vital™ Blood Glucose Meter is a precise If the battery is changed within 30 seconds, the meter
instrument. Please handle it with care. Clean the outside of memory is not affected. You will not lose any past test
the meter with a damp cloth only. Dirt, dust, blood, control results and the settings are not affected.
solution, or water entering the meter could cause damage.
Your GLUCOCARD® Vital™ Blood Glucose Meter should However, if it takes longer than 30 seconds to change
not need decontamination as no blood or control solution the battery, or if the battery is dead before changing
should come into contact with the meter if the instructions it, the time and date settings may need to be reset.
are followed correctly. The first time the meter is turned on after changing the
Storage battery, you may see a display screen message (E00).
The GLUCOCARD® Vital™ Blood Glucose Meter is This means you should check that the time and date
designed to be stored within a 32°F - 122°F (0°C - 50°C) are correct. (See pages 10-13 for detailed instructions
temperature range. on changing the time and date).
24 25
How to Change the Battery Blood Glucose Testing
Step 1
Turn the meter off. The Lancing Device
The battery cover is on the back of the meter.
Step 2 Multilet (lancet)
Removable cap Lancing Button Adjustment dial
Pull the battery cover up with your finger or fingernail.
Remove battery cover.
Step 3 Multi-Lancet Device™ body
Remove the old battery. Band hooks
If necessary, turn the meter over and tap it gently against Protective cap Disposal-and-set
lever
the palm of your hand until the battery falls out. Avoid the
use of sharp objects that may damage the meter.
Special band Strap hole
Step 4
Insert the new battery. Groove of special band
26 27
Step 3: Twist off the Obtaining a Drop of Blood
protective cap.
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 4: Attach the
removable cap. 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 5: The Multi-Lancet Device offers 7 different levels Step 3: Choose a site on the side of a
of skin penetration. For soft or thin skin or first time use, fingertip to minimize pain.
select “1 or 2.” If the obtained amount of blood is
excessive, turn the dial to a lower setting. If the Step 4: Press the removable cap to
obtained amount of blood is insufficient, turn the the side of the fingertip. Press the
dial to a larger setting. lancing device button.
Level indications
28 29
WARNING: DO NOT share used lancets with another TESTING WITH GLUCOCARD® VITAL™
person. To prevent possible infection, a used lancet TEST STRIPS
should not be touched by another person.
The GLUCOCARD® Vital™ Blood Glucose Monitoring
System works with the GLUCOCARD® Vital™ Test Strips.
30 31
GLUCOCARD® Vital™ Test Strips Performing a Blood Glucose Test
These capillary action test strips require only 0.5 µl of blood Note: For Instructions on Alternate Site Testing, refer
and provide an end-fill sample application tip for easy to pages 37-43.
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, Step 1
the sample is drawn into the test strip reaction site. The Insert a GLUCOCARD® Vital™
glucose in the blood reacts with the enzyme on the test Test Strip into the meter. Insert
strip. This reaction produces a current, proportional to the the contact bars into the test
amount of glucose in the blood. The meter detects the strip port, with the reaction site
current and converts it into a blood glucose reading. facing up.
< <
The GLUCOCARD® Vital™ Test Strip
Step 2
Enough Not Too
Lance your finger using the Blood Enough Much
Lancing Device. Touch the sample Blood Blood
application tip at the end of the strip
at a 90 degree angle to the blood < <
CORRECT
34 35
Step 3 Alternate Site Testing (AST)
Always record your results in your self-testing logbook
along with other information such as insulin dosage, Important Information About AST
diet, and exercise. The result is automatically stored in Sites other than your fingertip may have fewer nerve
memory with the time and date. endings so obtaining a blood sample from these sites may
Step 4 be less painful. The technique for alternate site testing is
Remove the used test strip and dispose of it carefully. different from fingertip testing. Blood glucose results from
The meter shuts off automatically when the test strip is sites other than your fingertip could be significantly
removed. 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
36 37
Use Fingertip When Testing: Prepare Your Lancing Device: To order an AST Lancing Kit
• Within two hours after a meal containing the lancing device, lancets, and instructions,
• Within two hours after insulin dosing please call 800.566.8558.
• Within two hours after physical activity
• If you have a history of hypoglycemia, are Performing a Blood Glucose Test
experiencing low blood sugar, or suffer from From an Alternate Site
hypoglycemic unawareness (you cannot tell
Step 1
when you have low blood glucose)
Insert lancet
• To confirm your blood glucose level if your AST
and cock
result is not consistent with how you feel
lancing device.
• 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 Step 2
preferred method of testing under these circumstances. a) Insert a test strip into the
meter. Insert contact bars
If bruising occurs, you may choose to lance a fingertip
into test strip port with
instead.
reaction site facing up.
When the strip is inserted,
the meter turns on
Preparing to Test Your Blood Glucose
automatically. Make sure
From an Alternate Site all symbols appear on the <
<
screen (see page 9).
Choose a Site: Select a soft, fleshy area on the palm that
is free of visible veins and moles and away from bone. Test Strip Port
Wash the area with warm, soapy water. Contact Bars
Rinse and dry completely. If you use
alcohol wipes to cleanse the site, make Reaction Site
sure the area is dry before lancing the Insert into meter
Sample this way
site. Application Tip
(apply blood sample IMPORTANT!
to tip, blood will be
drawn to reaction site)
38 39
c) Press the release button on
the lancing device to lance
the skin. Continue to hold the
lancing device firmly against
b) Wait until strip with flash- the skin until a 0.5 µL blood
ing blood drop appears. drop forms.
(You now have 2 minutes
to apply blood drop before
meter shuts off).
d) Once a large enough drop
of blood has formed, remove
the lancing device.
Step 3
a) Vigorously rub the selected
area for 5 to10 seconds until
it starts to feel warm to the
touch. Step 4
Pick up the meter. Touch the
end of the test strip at a 90
degree angle to the blood
sample until the reaction site
is full. Immediately remove the < <
b) Firmly hold the cocked meter and test strip from the
lancing device against the blood drop.
clean skin for 5 to10 seconds.
40 41
If the repeated alternate site result is still not consistent
IMPORTANT with how you feel, confirm your blood glucose level with
fingertip testing.
• Was the sample free of clear or
watery fluid? Enough
Blood
• Was the drop large enough Step 6
(at least 0.5 µL)? Always record your results in your self-testing log book
• Did the reaction site fill with along with other information such as insulin dosage, diet,
Not
enough blood all at once? Enough and exercise.
Blood
IF NOT, REPEAT TEST. The result is automatically stored in memory with the time
and date.
Step 5 Step 7
The meter will count down and Remove the test strip and dispose of it in accordance
display result in 7 seconds. with local regulatory guidelines or as directed by your
healthcare professional.
CONSIDER YOUR RESULT.
REPEAT ALTERNATE SITE TEST: The meter shuts off automatically when the test strip is
• IF the blood sample appeared to removed.
be diluted with clear fluid.
• IF you did not vigorously rub the
test site. Using Assure® Dose Control Solution
Enough Not Too
Enough Much Use the Assure® Dose Control Solution to check that the
Blood
Blood Blood meter and test strips are working correctly. It is important
that you carry out this simple check regularly.
• IF the blood drop was not large enough to fill the
Assure® Dose Control Solution contains a known amount
reaction site
of glucose that reacts with the GLUCOCARD® Vital™
• IF the test was accidentally marked as a “Control” result.
Test Strip.
• IF your result was not consistent with how you feel.
Assure® Dose Control Solutions are available in two levels -
Any of the above situations can
Normal and High.
lead to an inaccurate test result.
42 43
Compare the control solution test results with the range Performing a Control Solution Test
printed on the test strip bottle label.
Call your local supplier or pharmacy if you need to order Before performing a control solution test, always check
control solution. If they do not stock the product, please the expiration date ( ) of the control solution. Do not
call Order Services at 800.566.8558 (USA and Canada use control solution if it is past the expiration date or if the
only). solution has not been stored correctly. When you open
a new bottle of control solution, always write the date of
opening on the control solution label. As soon as you have
Use Control Solution: used the control solution, put the cap back on the bottle.
Always use the control solution within 90 days (3 months)
• Before testing with the GLUCOCARD® Vital™ System
of first opening.
for the first time.
• When you open a new bottle of test strips. Step 1
• Whenever you suspect the meter or test strips Insert a GLUCOCARD® Vital™ Test Strip
may not be functioning properly. into the test strip port of the meter
with contact bars facing up. The
• If test results appear to be abnormally high or meter turns on automatically.
low or are not consistent with clinical symptoms.
The full screen appears briefly. If any
• If the test strip bottle has been left open or has part of the display screen is missing
been exposed to light, temperatures below (see page 9), call Customer Service.
39°F(4°C) or above 86°F(30°C), or humidity The screen then displays the strip
levels above 80%. symbol and flashing blood drop. < <
• To check your technique.
• When the GLUCOCARD® Vital™ Meter has been Test Strip
dropped or stored below freezing or above Port
122°F(50°C). Contact
Bars
• Each time the batteries are changed.
44 45
Step 2
Note: Dye added to control solution may
You must press the Back or Forward
stain surfaces or fabric. Use with care.
button BEFORE performing control
solution test.
Hold the Back or Forward button
until appears in the upper right
corner of the screen. Verify that Step 5
remains displayed on the screen. Compare the result with
< <
If you do not do this, the control the range printed on the
solution result will NOT be valid. test strip bottle you are
will prompt you to add using. Values may vary
control solution. from bottle to bottle.
Verify that the result is
within range of the
Step 3 control solution level < <
Mix control solution by gently that you are using.
inverting control solution bottle If the result falls within
several times. Remove the cap from the range on the bottle,
the control solution bottle. Place the meter is working
cap on flat surface. Squeeze the correctly. 06146A
2010-10
bottle and discard the first drop. Control Solution Range (mg/dL)
Normal: 80-120
of the cap. <
High: 200-300
Step 4 Step 6
Bring meter and strip at a 90 degree Remove the test strip. The meter shuts off automatically
angle to drop. when the test strip is removed.
Test strip will draw up the solution. Dispose of the test strip immediately.
The meter will show result in 7 seconds.
46 47
Comparing Control Solution Results
NOTE: If your control solution result continues to fall
If the result is outside the range printed on the test strip
outside the required range, the system may not be
bottle, repeat the test. One or more of the following may
working correctly. DO NOT USE the system to test your
have caused an out-of-range result:
blood. If you are unable to resolve the problem, call
• The meter was not placed in control solution mode Customer Service at 800.566.8558 (24 hours a day,
before adding control solution 7 days a week, USA and Canada only).
• The control solution has expired or has been
contaminated
• The control solution was stored below 59°F (15°C) or Comparing Meter & Laboratory Results
above 86°F (30°C) Your GLUCOCARD® Vital™ Blood Glucose Meter is
• First drop of control solution was not discarded referenced to fresh plasma blood measurement. This
• The test strip was not stored correctly was performed in a clinical laboratory with glucose
• The test strip was used after the expiration date on standard calibration to the NIST (National Institute of
the bottle Science and Technology, Gaithersburg, MD, USA).
• The test strip bottle was open for more than 90 days The results you get from your meter may differ from
(3 months) the tightly controlled clinical laboratory result. This is due
• The GLUCOCARD® Vital™ meter has been damaged to normal variation. To make an accurate comparison
or has malfunctioned between the meter and laboratory results, follow the
• Contamination due to the tip of the control solution guidelines below.
bottle touching the test strip
Before You Compare
Repeat the test, carefully following instructions, using Perform a control solution test to make sure your meter
control solution mode with new control solution or a new and test strips are working correctly. Wait at least 2 hours
test strip, as appropriate. Compare the result with the after a meal or drink (other than water) before doing
range printed on the test strip bottle you are using. comparison blood tests. Fasting is essential if venous blood
is required for the reference analyzer.
48 49
When at the Laboratory Circulating blood glucose fluctuates naturally over time.
The capillary samples for both tests must be taken and Test results can vary over time and can be affected by
tested within 15 minutes of each other. The sample must several factors. Some of these include, but are not limited
be collected with anticoagulant appropriate to the to, the following: (1) time of day the test was performed;
laboratory analyzer. The recommended technique should (2) food eaten; (3) activities performed; (4) insulin and
be followed. Analysis should be performed following the other medications taken. If your result does not seem
manufacturer’s guidelines. correct after testing your blood, repeat the test. If
abnormally high or low readings persist, contact your
ALWAYS wash hands in warm, soapy water. Rinse and dry
healthcare professional.
them thoroughly before testing.
ALWAYS use fresh capillary whole blood on meter tests.
Expected Blood Glucose Readings
You may still experience a difference from the laboratory
Expected blood glucose levels for people without diabetes:
result because blood glucose levels can change over
short periods. This can be for a variety of reasons, such as mg/dL
1
50 51
Low Blood Glucose Readings Frequency of Testing
How often you need to test your blood glucose will vary
If your blood glucose is below 20 mg/dL, you will receive a according to your age, the type of diabetes you have,
“Lo.” Repeat the test with a new test strip. If this message the medications you are taking, and your physical and
shows again, contact your healthcare professional emotional health. Your healthcare professional will guide
immediately! you. After deciding when and how often you should test,
3 it is important that you make testing part of your routine.
Contact your physician for advice if test results are very low
(below 70 mg/dL) and/or you have symptoms of low blood Recommendations for better diabetes control
glucose. Symptoms of low blood glucose include sweating, • Follow the advice of your healthcare professional.
shakiness, trembling, blurred vision, hunger, headache, • Follow the exercise and meal plans recommended
confusion, rapid heartbeat, or tingling or numbness around by your healthcare professional.
the mouth or fingertips. Symptoms will vary from person to • Take insulin or diabetes medication at your
person. You may have one or all of these symptoms. scheduled times.
• Keep in touch with your emotional and physical
Diabetes Findings
condition.
In 1993, the National Institute of Health concluded an
• Stress or illness can affect diabetes.
extensive long-term study of people with Type 1 diabetes. This
• Watch for symptoms of hypoglycemia (low blood
study, called the Diabetes Control and Complications Trial
glucose) and hyperglycemia (high blood glucose).
(DCCT), found that by keeping your blood glucose close to
• Always record your test results in your logbook. The
the levels of people without diabetes you can reduce the
logbook assists you in keeping a record of your blood
risk of complications involving the eyes, kidneys, and nervous
4 glucose results, along with information on your food
system by approximately 60% .
intake, exercise, and medication.
• Review your logbook of test results with your
What This Means for You
healthcare professional regularly.
Frequent blood glucose testing is the best means you have
for keeping track of how well you are doing with the factors
that affect your diabetes-medication, diet, exercise, and References
stress management. Blood glucose test results can also tell 1 Joslin Diabetes Center. Goals for Blood Glucose Control. [Electronic Version].
you whether your diabetes is changing in ways that might Retrieved July 28, 2009. www.joslin.org/Beginners_guide_523.asp.
2 Krall, L.P. and Beaser R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Fibiger
require an adjustment to your treatment plan. Always consult (1989), 261–263.
3 Kahn, R. and Weir, G.: Joslin’s Diabetes Mellitus. Philadelphia: Lea and Fibiger
your healthcare professional before making any changes in (1994), 489.
4 American Diabetes Association position statement on the Diabetes Control and
managing your diabetes. Complications Trial (1993).
52 53
SPECIFICATIONS WARNINGS, PRECAUTIONS, & LIMITATIONS
Test Strips: GLUCOCARD® Vital™ • The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not
Result range: 20 to 600 mg/dL designed to substitute for pathology laboratory equipment and
should not be used for the diagnosis of diabetes.
Calibration: Plasma referenced
• Severe dehydration (excessive water loss) may cause false low
Sample Size: Minimum 0.5 μL results. If you believe you are suffering from dehydration, consult
your healthcare professional immediately.
Blood Source: Capillary Whole Blood
• A red blood cell count (hematocrit) that is very high (above 52%)
Hematocrit Range: 33%-52% can give abnormally low results. A very low hematocrit level
Test Time: 7 seconds (below 33%) can give abnormally high results.
• Inaccurate results may occur in severely hypotensive individuals
Glucose Units: mg/dL
or patients in shock.
Assay Method: Biosensor, Glucose oxidase • Inaccurate low results may occur for individuals experiencing a
(Aspergillus niger sourced) hyperglycemic-hyperosmolar state, with or without ketosis.
Power Source: Single replacement 3V • Patients undergoing oxygen therapy may yield false results.
(CR2032) battery • Do not use to test newborns. The system has not been validated
Battery Life: More than 2,000 tests at for neonatal use.
4 tests per day • Do not use the GLUCOCARD® Vital™ system at altitudes in excess
Display Type: Liquid Crystal Display (LCD) of 10,000 ft (3,048 m).
• Triglycerides up to 3,300 mg/dL do not significantly affect test
Memory: 250 results with 14- and results. However, glucose values in specimens beyond this
30-day averaging
triglycerides level should be interpreted with caution.
Automatic Shut-off: 2 minutes after last user action • Metabolites of icodextrin (maltrose, maltotrise, and maltotetraose)
Size: Approx. 3" x 2" x ½" do not affect test results.
(80 mm x 46 mm x 16 mm) • Use only fresh capillary blood. Do not use serum or plasma or
Weight: Approx. 1½ oz. (39 g) venous whole blood.
Optimum Operating Ranges: 50°F - 104°F (10°C - 40°C) IMPORTANT: Low or high blood glucose readings can indicate a potentially serious
medical condition. If your blood glucose reading is unusually low or high, or you do not
Relative Humidity: 20% - 80% feel the way your readings indicate, repeat the test using a new strip. If your result is still
not consistent with your symptoms or if your blood glucose result is less than 60 mg/dL
Altitude: 10,000 ft. (3,048 meters) or higher than 240 mg/dL, contact your diabetes healthcare
professional for advice.
54 55
THE LANCING DEVICE
WARRANTY
ARKRAY warrants that the Lancing Device functions
THE GLUCOCARD® VITAL™ BLOOD GLUCOSE METER effectively for a period of 3 years from the date of
You are a valued customer of ARKRAY. It is important to us purchase. A malfunctioning device should not be
that you are completely satisfied with your GLUCOCARD® returned to your supplier or to ARKRAY unless you receive
Vital™ Blood Glucose Meter. an authorization number to do so.
56 57
Notes Notes
58 59
TEL 800.566.8558
FAX 952.646.3110
www.arkrayusa.com
P/N 1850-00
60 Rev 3/09