For single user / home use only
User Manual
SISTEMA DE MONITOREO DE GLUCOSA EN SANGRE
Manual del usuario
Para un solo usuario / uso domiciliario únicamente
Bienvenido al sistema de monitoreo de
glucosa en sangre GLUCOCARD® Shine XL
Gracias por elegir el Sistema de monitoreo de glucosa
en sangre GLUCOCARD® Shine XL. El sistema le
proporciona un monitoreo de diagnóstico seguro, rápido
y cómodo para el control de glucosa en sangre in vitro
(es decir, externo). Usted puede obtener resultados
precisos en solo cinco segundos con una pequeña
(0.5 μL) muestra de sangre.
© 2017. All Rights Reserved.
P/N 5399-00 Rev. 08/17
PGK7E0172 Rev0 08/2017
24 hours a day, 7 days a week, U.S.A. and Canada
At all other times or in case of emergency, please
contact your healthcare professional or emergency
medical response.
800.566.8558
Customer Service
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
800.566.8558
www.arkrayusa.com
ARKRAY USA
DISTRIBUIDO POR:
DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 USA
800.566.8558
www.arkrayusa.com
Servicio al cliente
800.566.8558
24 horas al día, 7 días a la semana, en Estados Unidos
y Canadá.
Fuera de ese horario o en caso de emergencia,
póngase en contacto con su profesional de atención
médica o con un servicio de respuesta ante
emergencias médicas.
© 2017. Todos los derechos reservados.
N.º de ref.: 5399-00 Rev. 08/17
PGK7E0172 Rev0 08/2017
Thank you for choosing the GLUCOCARD® Shine XL
Blood Glucose Monitoring System. The system provides
you with safe, fast and convenient blood glucose in vitro
(i.e., outside the body) diagnostic monitoring. You can
obtain accurate results in just 5 seconds with a small
(0.5 µL) blood sample.
Welcome to the GLUCOCARD® Shine XL
Blood Glucose Monitoring System
Table of Contents
Information
Important Information: Read This First________________________________
Important Health-related Information__________________________________
Specifications_______________________________________________________
GLUCOCARD® Shine XL Blood Glucose Monitoring System _____________
Inserting or Replacing the Batteries___________________________________
GLUCOCARD® Shine Blood Glucose Test Strips________________________
GLUCOCARD® Shine XL Blood Glucose Meter__________________________
GLUCOCARD® Shine XL Blood Glucose Meter Display__________________
Preparation
Setting Up the GLUCOCARD® Shine XL System________________________
Adjusting the Date and Time________________________________________
Setting the Sound ‘On’/‘OFF’________________________________________
Setting the ‘Test Result Reset’______________________________________
Checking the System________________________________________________
Control Solution Testing____________________________________________
Comparing the Control Solution Test Results_________________________
Blood Glucose Testing
Using the Lancing Device____________________________________________
Preparing the Lancing Device_______________________________________
Preparing the Meter and Test Strip___________________________________
Flagging Post-meal Test Results_____________________________________
Applying the Blood Sample_________________________________________
Discarding Used Lancets___________________________________________
Alternate Site Testing________________________________________________
‘HI’ and ‘Lo’ Messages_______________________________________________
Target Blood Glucose Ranges_________________________________________
Transferring Test Results_____________________________________________
Additional Functions
Meter Memory______________________________________________________
Viewing Stored Test Results________________________________________
Setting the Alarm Function___________________________________________
Setting the Post-meal Alarm (PP2 Alarm)_____________________________
Setting the Time Alarms (Alarm 1 - 3)________________________________
Maintenance
Caring for the GLUCOCARD Shine XL System__________________________
Understanding Errors and Other Messages____________________________
General Troubleshooting_____________________________________________
Performance Characteristics__________________________________________
Warranty Information________________________________________________
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Important Information: Read This First
To receive safe and optimum system benefits, please read the
entire contents of this manual before using the system. Please
note the following instructions:
• Do not use the system for diagnosis or screening of diabetes
• Use only fresh capillary whole blood samples for testing
• Alternate site and fingertip test results may differ
significantly due to rapid changes in the blood glucose level
after eating, insulin injection or exercise
Intended Use
• The GLUCOCARD® Shine XL Blood Glucose Monitoring System
is intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertips
and alternate sites such as the forearm, palm, thigh and calf.
• Alternate site testing (AST) should be used only during steadystate blood glucose conditions.
• The GLUCOCARD® Shine XL Blood Glucose Monitoring System
is intended for self-testing outside the body (in vitro) by people
with diabetes as an aid to monitor the effectiveness of diabetes
control. It is not intended for use on neonates, and is not for
the diagnosis or screening of diabetes.
• GLUCOCARD® Shine Blood Glucose Test Strips are for use with
the GLUCOCARD® Shine family of blood glucose meters to
quantitatively measure glucose in fresh capillary whole blood
samples drawn from the fingertips and alternate sites.
• GLUCOCARD® Shine Control Solutions are for use with the
GLUCOCARD® Shine family of meters and GLUCOCARD® Shine
Test Strips to check that meter and test strips are working
together properly, and the test is performing correctly.
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Important Health-related Information
• The GLUCOCARD Shine XL Blood Glucose Monitoring
System is intended for self-testing in vitro (outside the body)
diagnostic use.
• The GLUCOCARD Shine XL Blood Glucose Meter is designed
to minimize code related errors in monitoring by using the
no-coding function.
• Glucose in blood samples reacts with the chemical in the test
strip to produce a small electrical current. The GLUCOCARD
Shine XL Meter detects this electrical current and measures
the amount of glucose in the blood sample.
• The GLUCOCARD Shine XL Blood Glucose Meter should only
be used with GLUCOCARD Shine Test Strips.
• An abnormally high or low red blood cell count (hematocrit
level over 60% or below 20%) may produce inaccurate results.
• Inaccurate results may occur in severely hypotensive (having
low blood pressure) individuals or patients in shock.
• Inaccurate low results may occur for individuals experiencing
a hyperglycemic-hyperosmolar state, with or without ketosis.
• Critically ill patients should not be tested with blood
glucose meters.
• Inaccurate results may occur in patients undergoing
oxygen therapy.
• For questions or concerns, contact Customer Service:
800.566.8558, 24 hours a day, 7 days a week, U.S.A.
and Canada. In case of emergency, please contact your
healthcare professional or emergency medical response.
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Specifications
Product Specifications
Measurement range
20 - 600 mg/dL
Sample size
Minimum 0.5 μL
Test time
5 seconds
Sample type
Fresh capillary whole blood
Calibration
Plasma-equivalent
Assay method
Electrochemical
Battery life
5,000 tests
Power
Two 3.0 V lithium batteries
(disposable, type CR2032)
Memory
Size
250 test results
3.66 x 1.85 x 0.59 inch (93 x 47 x 15 mm)
Weight
1.82 oz (51.5 g) with batteries
Operating Ranges
Temperature
Relative humidity
50–104ºF (10–40ºC)
10–90%
Hematocrit
20–60%
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GLUCOCARD Shine XL BGMS
GLUCOCARD Shine XL Blood Glucose Monitoring
System (BGMS) includes the following items:
 GLUCOCARD Shine XL Blood Glucose Meter
 User Manual
 Quick Reference Guide
 Batteries (2)
 Lancing Device
 Lancets (10)
 Logbook
 Carrying Case
• Check all the components after opening the GLUCOCARD
Shine XL Blood Glucose Monitoring System package.
• GLUCOCARD Shine Control Solutions are necessary but
not included.
• GLUCOCARD Shine Control Solutions and the data cable for
the diabetes management system can be ordered separately.
Please contact Customer Service: 800.566.8558, 24 hours a
day, 7 days a week, U.S.A. and Canada.
www.arkrayusa.com 7
Inserting or Replacing the Batteries
• The GLUOCARD Shine XL Meter comes with two 3.0 V
lithium batteries.
• Before using the meter, check the battery compartment and
insert batteries if empty.
symbol appears on the display while the meter
• When the
is in use, the batteries should be replaced as soon as possible.
• The test results may not be saved if the batteries run out
completely.
Step 1
Make sure the meter is turned off. Push the
cover in the direction of the arrow to open
the battery compartment.
Step 2
Remove the used batteries. Insert two new
batteries with the ‘+’ side facing up and
make sure the batteries are inserted firmly.
Step 3
Place the cover on the battery compartment.
Push down firmly to close the cover.
NOTE
• Removing the meter batteries will not affect your stored
result. However, meter settings may need to be reset.
See pages 13–17.
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GLUCOCARD Shine Blood Glucose Test Strip
The GLUCOCARD Shine XL Blood Glucose Monitoring
System measures blood glucose quickly and accurately.
It automatically absorbs the small blood sample applied to
the narrow edge of the test strip.
Insert
Contact bars
Gently push the test strip, with its
contact bars facing up, into the test
strip port of the meter
Confirmation window
Check here to see whether
sufficient blood sample has
been applied
Edge to apply blood sample
Apply blood sample here for testing
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Important Safety Instructions
•GLUCOCARD Shine Test Strips should be used only with
fresh capillary whole blood samples.
•Do not reuse test strips.
•Do not use GLUCOCARD Shine Test Strips beyond the
expiration date. This may cause inaccurate results.
•When test strips are used and stored according to correct
storage and handling methods, both new, unopened vials
and vials that have been opened can be used until the
expiration date printed on the test strip box and vial label.
•Store test strips in a cool and dry place at a temperature
between 34–86ºF (1–30ºC).
•Keep test strips away from direct sunlight or heat and do
not freeze.
•Store test strips only in their original vial.
•Close the vial tightly after taking out a test strip for
testing and use the test strip immediately.
•Handle test strips only with clean, dry hands.
•Do not bend, cut or alter test strips in any way.
•For detailed storage and usage information, refer to the
GLUCOCARD Shine Test Strip package insert.
•Keep the meter and testing supplies away from
young children.
•The test strip vial contains drying agents that are
harmful if inhaled or swallowed, and may cause skin
or eye irritation.
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GLUCOCARD Shine XL Blood Glucose Meter
Data Port
Used to transfer data
from the meter to a
computer with
a cable
Display
Shows results
and messages
<Button
Turns the meter
on and selects
or changes
information
>Button
Selects or
changes
information
Button
Turns the meter
on/off and confirms
menu selections
Test Strip Port
Insert test strip here
NOTE
• The data cable for the diabetes management system can
be ordered separately. Please contact Customer Service:
800.566.8558, 24 hours a day, 7 days a week, U.S.A.
and Canada.
www.arkrayusa.com 11
GLUCOCARD Shine XL Meter Display
mem
Mute symbol
appears when test
results stored in
the memory are
displayed
appears only when
the sound is set
to ‘OFF’
check
appears when test
results have not
been saved
alarm
appears when
the time alarm
has been set
Test results
test results
display panel
Battery symbol
indicates meter
batteries are running
low and need to
be replaced
mg/dL
unit for measuring
blood glucose
Post-meal test mark
appears during postmeal testing and
when post-meal test
results are displayed
Alarm symbol
appears when the
post-meal alarm
has been set
NOTE
Date
Time
Blood insertion
symbol
indicates meter
is ready for the
application of a
drop of blood or
control solution
• The unit of measurement for your GLUCOCARD Shine XL
Meter is preset and fixed in mg/dL.
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Setting Up the GLUCOCARD Shine XL System
The meter settings, such as time and date, should be checked
and updated before using the meter, or after changing the meter
batteries.
button for 3 seconds to enter the ‘SET’
Press and hold the
mode. While setting up the meter, current settings will appear
on the display. Press and hold the > button to scroll faster. To
complete the settings and exit from the ‘SET’ mode, press and
button for 3 seconds again.
hold the
Adjusting the Date and Time
Step 1 Entering the SET Mode
Press and hold the
button for 3 seconds.
After all the segments flash across the screen,
‘SET’ is displayed on the screen. Press the
button again to progress to the next step.
Step 2 Setting the Year
Press the < or > button until correct year
appears. Press and hold the > button to scroll
button
faster. After setting the year, press the
to confirm the selection and progress to the
next step.
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Step 3 Setting the Month
A number indicating the month will blink on
the bottom left corner of the screen. Press the
< or > button until the correct month appears.
button to confirm the selection
Press the
and progress to the next step.
Step 4 Setting the Date
Press the < or > button until blinking number
button to
shows the correct date. Press the
confirm the date and progress to the next step.
Step 5 Setting the Time Format
The meter can be set in the 12-hour (AM/PM)
or the 24-hour clock format. Press the < or >
button to select a format. AM and PM are not
displayed in the 24-hour format. After selecting
button to progress to
the format, press the
the next step.
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Step 6 Setting the Hour
Press the < or > button until the correct hour
button to confirm the hour
appears. Press the
and progress to the next step.
Step 7 Setting the Minute
Press the < or > button until the correct
minute appears. After setting the minute, press
button to progress to the next step.
the
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Setting the Sound ‘On’/‘OFF’
Step 8
On pressing the < or > button, the screen will
button to
display ‘On’ or ‘OFF’. Press the
confirm the selection. The meter will beep in
the following instances if set to ‘On’.
or < button is pushed to turn
•W
hen the
on the meter
• When the test strip is inserted in the meter
• When the blood sample is absorbed into the
test strip and the test starts
• When the test result is displayed
• When the < button is pushed to set the
post-meal (PP2) alarm
• When it is time for a preset blood glucose test
If the sound is set to ‘OFF’, none of the sound functions
button
will work. After setting the sound, press the
to progress to the next step.
NOTE
•
symbol is displayed only when the sound is set to ‘OFF’.
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Setting the ‘Test Result Reset’
(Deleting all the saved test results)
Step 9
In this mode all the test results stored in the meter can be
deleted. Please note that if you select ‘YES’, all the stored test
results will be deleted and can not be restored.
• The ‘dEL’ character will blink
on the screen.
• Press the < or > button to
alternate between ‘YES’
or ‘no’.
• To delete all the stored test
button
results, press the
while the screen displays ‘YES’. Then, all the test results
stored in the meter will be deleted and the screen will be
similar to the picture above.
button
If you do not want to delete the results, press the
while the screen displays ‘no’. Then, the screen will return to
step 2 (See page 13).
NOTE
• At any stage, if the
button is pressed for 3 seconds, time
and date will be saved, and the meter will be turned off.
• Press and hold the > button to scroll through numbers quickly.
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Checking the System
The GLUCOCARD Shine XL Meter and GLUCOCARD
Shine Test Strips should be checked using
GLUCOCARD Shine Control Solution, available in two
levels (Level 1 and 2). The GLUCOCARD Shine Control
Solutions contain known amounts of glucose and are
used to check that the meter and test strips are working
properly.
The test strip vials have GLUCOCARD Shine Control
Solution ranges printed on their labels. Compare the
result displayed on the meter to the control solution range
printed on the test strip vial.
Before using a new meter or new vial of test strips, you should
conduct a control solution test using GLUCOCARD Shine
Control Solutions.
Follow the procedure that begins on page 19.
NOTE
•Use GLUCOCARD Shine Control Solutions only.
•Check the expiration date printed on the bottle. When the
control solution bottle is first opened, record the discard date
(date opened plus three (3) months) in the space provided on
the label.
•Make sure the meter, test strips and control solutions are at
room temperature before testing. Control solution tests must
be done at room temperature (68–77ºF, 20–25ºC).
•Before using the control solution, shake the bottle, discard
the first 1 or 2 drops and wipe the tip clean.
•Close the control solution bottle tightly and store at a
temperature between 46–86ºF (8–30ºC).
18 www.arkrayusa.com
Use GLUCOCARD Shine Control Solution when:
• You want to practice the test procedure, instead of
using blood
• You use the meter for the first time
• You begin using a new vial of test strips
• You suspect the meter or test strips are not working properly
• You think your test results are inaccurate or they do not reflect
how you feel
• The meter is dropped or damaged
Control Solution Testing
Step 1
Insert a test strip into the meter’s test strip
port, with the contact bars facing upwards.
Gently push the test strip into the port until the
meter automatically turns on and the
symbol appears.
Step 2
Shake the GLUCOCARD Shine
Control Solution bottle well before
each test. Remove the cap and
squeeze the bottle to discard the first
1 or 2 drops. Then wipe the tip with
a clean tissue or cloth.
Dispense a drop of control solution
symbol
onto a clean non-absorbent surface. While the
blinks, apply the control solution to the narrow edge of the
test strip until the meter beeps. Make sure the confirmation
window of test strip fills completely.
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NOTE
• The meter will switch off if the control solution sample is not
symbol appearing on
applied within 2 minutes of the
the screen.
or < button and start
• If the meter turns off, press the
from step 2.
Step 3
A test result will appear after the meter counts
down from 5 to 1.
After your control solution result appears on
the display, press the > button for 3 seconds
until ‘check’ appears on the display.
When ‘check’ is displayed, the result is not
stored in the meter’s memory and is not
included in the 14-day averages.
Step 4
Compare the result displayed on the meter
to the range printed on the test strip vial.
The result should fall within that range.
Used strips should be discarded safely in
disposable containers.
Caution
• The ranges printed on the test strip vial are for GLUCOCARD
Shine Control Solutions only.
• They do not have any connection to your blood glucose level.
20 www.arkrayusa.com
Comparing the Control Solution Test Results
The test result of each control solution should be within the
range printed on the label of the test strip vial. Repeat the
control solution test if the test result falls outside of this range.
Out of range results may occur due to the following factors:
Situations
Actions
•When the control solution bottle was not
shaken well
•When the meter, test strip or the control
solution were exposed to high or low
temperatures
•When the first one or two drops of control
solution were not discarded, or the tip of
the bottle was not wiped clean
•When the meter is not functioning properly
Repeat the
control solution
test by referring
to the ‘NOTE’
on page 20.
•When the control solution is past the
expiration date printed on the bottle
•When the control solution is past its
discard date (the date the bottle was
opened plus three (3) months)
•When the control solution is contaminated
Discard the used
control solution
and repeat the
test using a new
bottle of control
solution.
If results continue to fall outside the range printed on the test
strip vial, the GLUCOCARD Shine XL Meter and GLUCOCARD
Shine Test Strips may not be working properly. Do NOT use
your system and contact Customer Service: 800.566.8558,
24 hours a day, 7 days a week, U.S.A. and Canada
NOTE
• GLUCOCARD Shine Control Solutions can be obtained by
contacting Customer Service: 800.566.8558.
www.arkrayusa.com 21
Using the Lancing Device
A lancing device is needed in order to collect a blood sample.
You may use the lancing device contained in the GLUCOCARD
Shine XL Blood Glucose Monitoring System or any other
medically approved lancing device.
Adjustable Cap
Lancet Holder
Lancet
Ejection System
Release Button
Charger
• The lancing device is for use by a single user only and should
not be shared with anyone, including other family members.
CAUTION
To reduce the chance of infection:
• Do not use a lancet more than once
•Do not use a lancet that has been used by others
•Always use a new sterile lancet
•Keep the lancing device clean
NOTE
• Repeated puncturing at the same sample site may cause
pain or skin calluses (thick hard skin)
• Choose a different site each time you test
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Preparing the Lancing Device
Step 1
Wash hands and the sample site with
soap and warm water. Rinse and dry
thoroughly.
Step 2
Unscrew and remove the adjustable cap.
Step 3
Insert a new disposable lancet firmly into
the lancet holder. Twist off the protective
cover of the lancet and set it aside, then
replace the adjustable cap. Keep the
protective cover to put on top of the
used lancet after testing.
Step 4
The lancing device has five puncture
depth settings, numbered 1 through 5.
The smaller numbers are for a shallower
puncture and the larger numbers are for
a deeper puncture. Choose a depth of
penetration by rotating the top portion
of the adjustable tip until the setting
number matches the arrow.
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Step 5
Cock the lancing device by holding the
body in one hand and pulling on the
charger. A click may be heard.
NOTE
• The skin depth to retrieve samples will vary for various
people at different sample sites.
• The lancing device’s adjustable cap allows the best depth of
skin penetration for an adequate sample size.
• A beginning setting of three (3) is recommended.
Preparing the Meter and Test Strip
Step 6
Insert a test strip with the contact bars facing up into the
meter’s test strip port.
Push the test strip gently into the test strip port until the meter
symbol appears.
automatically turns on and the
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Flagging Post-meal Test Results
• GLUCOCARD Shine XL Meter allows post-meal test to be
flagged with the symbol.
•T
he post-meal flag ( ) can be attached and deleted just
before applying the blood sample.
•O
nce the test result is saved with the post-meal flag ( ),
it cannot be deleted.
Step 7
To attach a post-meal flag ( ) to a test result,
press and hold the > button for 3 seconds after
inserting the test strip.
The post-meal flag ( ) and the
will appear on the screen.
symbol
The test result will also be displayed with the
post-meal flag ( ).
If you do not want to save the result as a postmeal test, move on to Step 8 after Step 6. If you
want to delete the post-meal flag ( ) that has
been attached, press and hold the > button for 3
seconds again before applying the blood sample.
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Applying the Blood Sample
Step 8
Obtain a blood sample using the lancing
device. Place the device against the pad
of the finger. The best puncture sites are
on the middle or ring fingers.
Press the release button. Remove the
lancing device from the finger. Wait a
few seconds for a blood drop to form.
A minimum volume of 0.5 microliter is needed to fill the
confirmation window.
Step 9
After the
symbol appears on the
screen, apply the blood sample to the
narrow end of the test strip until the
meter beeps.
If the blood sample does not fill the
confirmation window completely, an
‘Er4’ message may appear because
of abnormal viscosity or insufficient
volume.
Approximate size
Good
Then discard the test strip, insert a new
Sample
one, and apply the blood sample again
symbol appears on the screen.
after the
26 www.arkrayusa.com
Insufficient
Sample
NOTE
• The meter will switch off if the blood sample is not
applied within 2 minutes of the
symbol appearing
on the screen.
or < button and
• If the meter turns off, press the
apply the blood sample after the
symbol appears
on the screen.
Step 10
The test result will appear after the meter
counts down from 5 to 1.
The result will be automatically stored in
the meter memory.
If the test strip is removed after the test
result has been displayed, the meter will
automatically switch off after 3 seconds.
Discard used test strip safely in a
disposable container.
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Discarding Used Lancets
Step 1
Unscrew the lancing device‘s
adjustable cap.
Step 2
Place the protective cover on the lancet.
Remove lancet and dispose of the used
lancet in a proper biohazard container.
CAUTION
• Check for damage before using the lancet. If it has been
damaged, please discard it and use another lancet.
• The lancet is very sharp. Please keep away from children.
• Keep the lancets in a cool and dry place.
• The lancet is for single use only. Never share or reuse a
lancet. Always dispose of lancets properly.
28 www.arkrayusa.com
Alternate Site Testing
What is AST (Alternate Site Testing)?
When someone tests their glucose, they usually take the blood
sample from the tip of the finger.
However, since there are many nerve endings in the fingertip,
it can be painful. When doing a glucose test, using different
parts of the body, such as the forearms, palms, thighs and
calves, can reduce pain during testing.
This method of testing with different parts of the body is called
Alternate Site Testing. While AST may reduce pain during
testing, it may not be simple for everyone and the following
precautions should be observed during testing.
Alternate Site Blood Sampling (forearm, palm, thigh, calf)
Select a clean, soft and fleshy sample site area free of visible
veins and hair, and away from bones.
Gently massage the sample site to help blood circulation to
minimize result differences between fingertip and alternate
site sampling.
Firmly press and hold the lancing device against site. Wait until
the skin surface under the lancing device changes color. Then
press the release button while continuing to apply pressure.
Keep holding the lancing device against your skin until sufficient
(at least 0.5 μL) blood is drawn.
Carefully lift the lancing device away from your skin.
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CAUTION
• AST results should never be used to calibrate Continuous
Glucose Monitoring Systems nor entered into an insulin
dosing calculator or pump for dosing recommendations.
Things to Know When Using AST
Please read the following before testing at alternate sites
(forearms, palms, thighs and calves).
The capillary whole blood of fingertips reflects changes in
glucose levels more rapidly than in alternate sites. The test
results from fingertip testing and AST may differ due to factors
such as lifestyle and eating food which affect glucose levels.
Acceptable Situations for AST
• When your blood glucose levels are stable
• Fasting period
• Before a meal
• Before going to bed
Situations Requiring Fingertip Test
• When your blood glucose levels are NOT stable
• Two (2) hours after a meal or exercise
• When sick or when glucose levels seem quite lower
than test value
• When hypoglycemia is not well recognised
• When insulin has the biggest effect
• Two (2) hours after an insulin injection
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AST Precautions
•Do not ignore the symptoms of hyperglycemia or
hypoglycemia.
• When the results of the test do not reflect the way you feel,
retest using the fingertip. If the fingertip result still does not
reflect the way you feel on retesting, please consult your
healthcare professional.
•Do not rely on the AST results for changing your treatment
method.
•The amount of glucose in alternate sites differs from person to
person.
•Before using AST, please consult your healthcare professional.
NOTE
• Results from alternate site and fingertip samples may differ
from each other, as there is a time lag for the glucose levels
to reach the same value.
• Use a fingertip sample if you suffer from hypoglycemia or
have experienced hypoglycemic shock or symptoms.
• If the sample drop of blood runs or spreads due to contact
with hair or with lines on your palm, do not use that sample.
Try puncturing again in a smoother area.
www.arkrayusa.com 31
‘HI’ and ‘Lo’ Messages
‘HI’ Message
The meter displays results between
20–600 mg/dL. ‘HI’ appears when the blood
glucose level is greater than 600 mg/dL and
indicates severe hyperglycemia (much higher
than normal glucose levels).
If ‘HI’ is displayed again upon retesting,
please contact your healthcare professional
immediately.
‘Lo’ Message
‘Lo’ appears when a test result is less than
20 mg/dL and indicates severe hypoglycemia
(very low glucose levels).
If ‘Lo’ is displayed again upon retesting,
please contact your healthcare professional
immediately.
NOTE
• If messages for hyperglycemia or hypoglycemia are
displayed even if you do not have those conditions, please
contact Customer Service: 800.566.8558, 24 hours a day,
7 days a week, U.S.A. and Canada.
32 www.arkrayusa.com
Target Blood Glucose Ranges
Reminders
Time of day
Your target ranges
from your healthcare professional
Before breakfast
Before lunch or dinner
1 hour after meals
2 hours after meals
Between 2 a.m. and 4 a.m.
Expected Values: The range of a normal fasting* blood glucose
level for non-diabetic adults is between 70–99 mg/dL.
Two (2) hours after a meal, the range of a normal blood glucose
level for non-diabetic adults is less than 140 mg/dL.
*Fasting is defined as no caloric intake for at least eight (8) hours.
Reference
American Diabetes Association. Standards of Medical Care in
Diabetes – 2016. Diabetes Care. January 2016; 39(1):S15, S100.
Transferring Test Results
Test results stored in GLUCOCARD Shine XL
Meter can be transferred from the meter to
the ARK Care® Advance Real-Time Diabetes
Management System via a data cable when the
data cable connects the meter with a computer.
For more information, contact Customer Service:
800.566.8558, 24 hours a day, 7 days a week,
U.S.A. and Canada.
www.arkrayusa.com 33
Meter Memory
The GLUCOCARD Shine XL Meter can save up to 250 glucose
test results with time and date. If the memory is full, the oldest
test result will be deleted and the latest test result will be stored.
The GLUCOCARD Shine XL Meter calculates and displays the
averages of total test results, pre-meal test results and post-meal
test ( ) results from the last 14 days.
Viewing Stored Test Results
Step 1
Press the < or
button to turn the meter on.
The current date and time will be displayed
on the bottom of the screen followed by the
average value and the number of the test
results saved within the last 14 days.
The number of tests for the last 14 days
Step 2
Press the > button to
view the average values
and the number of tests
performed before
eating a meal for the
last 14 days.
On pressing the > button
again, the average values
and the number of tests
performed post-meals
for the same period will
appear on the screen.
34 www.arkrayusa.com
>button
<button
The number of
pre-meal tests
for the last
14 days
The number of
post-meal tests
for the last
14 days
Step 3
Use the > button to scroll through the test results, starting
from the most recent and ending with the oldest.
Press the < button to return to the previous result.
After checking the stored test result, press the
turn off the meter.
button to
NOTE
• Press and hold the > button to scroll through the test results.
www.arkrayusa.com 35
Setting the Alarm Function
Four types of alarms can be set in the GLUCOCARD Shine XL
meter. One post-meal alarm (PP2 alarm) and three time set
alarms (alarm 1–3).
• The ‘PP2’ alarm goes off 2 hours after setting the alarm.
• The alarms ring for 15 seconds and can be silenced by
button or by inserting a test strip.
pressing the <, > or
Setting the Post-meal Alarm (PP2 Alarm)
Step 1 Setting the PP2 Alarm On
Without inserting a test strip,
press and hold the < button for
3 seconds to set the post-meal
symbol and
alarm. ‘PP2’, the
‘On’ will be displayed.
The screen will then
automatically change to the
memory check mode. At this
symbol, indicating that the ‘PP2’ alarm has been
time, the
set, will be displayed on the screen.
Step 2 Setting the PP2 Alarm ’OFF’
To turn off the ’PP2’ alarm,
press and hold the < button for
symbol
3 seconds. ‘PP2’, the
and ‘OFF’ will appear on
the screen.
Then the screen will change
automatically to the memory
symbol
check mode without
displayed.
36 www.arkrayusa.com
symbol disappears
Setting the Time Alarms (Alarm 1–3)
Step 1
Without inserting a test strip, press the < and
buttons simultaneously for 3 seconds to enter the
time alarm mode.
While ‘OFF’ blinks on the screen, alarm 1 will be
displayed.
Step 2
On pressing the > button, alarm 1 is set and
‘On’ is displayed on the screen.
Press the > button again to cancel alarm 1 and
‘OFF’ will blink on the screen.
Step 3
Press the < button to adjust the hour of
alarm 1.
A number indicating the hour will blink on
the screen.
Press the > button to set the hour.
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Step 4
Press the < button to adjust the minute of
alarm 1.
A number indicating the minute will blink on
the screen.
Press the > button to set the minute.
Step 5
Press the
button to finish and enter
alarm 2 mode.
Repeat steps 2 to 4 to set the remaining time
alarms (alarm 2 and 3).
Step 6
Press and hold the
the meter off.
38 www.arkrayusa.com
button for 3 seconds to finish and turn
Caring for the GLUCOCARD Shine XL System
Use a soft cloth or tissue to wipe the meter exterior. If
necessary, dip the soft cloth or tissue in a small amount
of alcohol.
Do not use organic solvents such as benzene, acetone, or any
household and industrial cleaners that may cause irreparable
damage to the meter.
CAUTION
Storage and Handling
• Do not expose the meter to direct sunlight or heat for
extended periods of time.
•Do not let dirt, dust, blood or water enter into the meter’s
test strip port.
•Do not drop the meter or subject it to strong shocks.
•Do not try to fix or alter the meter in any way.
•Keep the meter in a cool and airy place.
•Strong electromagnetic radiation may interfere with the
proper operation of this device. Keep the device away from
sources of strong electromagnetic radiation.
•Store all meter components in the carrying case to
prevent loss.
www.arkrayusa.com 39
Understanding Error and Other Messages
Message
What it means
What to do
A used test strip
was inserted.
Remove the strip and
insert a new
test strip.
The blood or control
solution sample
was applied before
the
symbol
appeared.
Repeat the test with
a new test strip and
wait until the
symbol appears
before applying the
blood or control
solution sample.
The temperature
during the test was
above or below the
operating range.
Move to an
area where the
temperature is within
the operating range
(50–104ºF) and
repeat the test after
the meter and test
strips have reached
a temperature within
the operating range.
40 www.arkrayusa.com
Message
What it means
The blood sample
has abnormally
high viscosity or
insufficient volume.
What to do
Repeat the test using
a new test strip.
This error message
may appear when
the wrong blood
glucose test strip is
used instead of the
GLUCOCARD Shine
Test Strip.
Repeat the test with
a GLUCOCARD Shine
Test Strip.
There is a problem
with the meter.
Do NOT use the
meter. Contact
Customer Service:
800.566.8558.
Insert the strip with
the contact bars
facing up, and push
in gently until the
meter turns on.
NOTE
• If the error messages persist, contact Customer Service:
800.566.8558, 24 hours a day, 7 days a week, U.S.A.
and Canada.
www.arkrayusa.com 41
General Troubleshooting
Problem
The display is blank
even after inserting
a test strip.
Troubleshooting
• Check whether the test strip is
inserted with the contact bars
facing up.
• Check if the test strip has been
inserted completely into the test
strip port.
• Check if the appropriate test strip
was used.
• Check if the batteries are inserted
correctly.
• Replace the batteries.
The test does not
start even after
applying the blood
sample on the
test strip.
• Check if the confirmation window
is filled adequately.
• Repeat the test after inserting a
new test strip.
The test result does
not match the way
you feel.
• Check to make sure the test strip has
not expired.
• Repeat the test after inserting a
new test strip.
• Perform control solution test.
NOTE
• If the problem is not resolved, please contact Customer
Service: 800.566.8558, 24 hours a day, 7 days a week,
U.S.A. and Canada.
42 www.arkrayusa.com
Performance Characteristics
The performance of GLUCOCARD Shine XL Blood Glucose
Monitoring System has been evaluated in laboratory and
clinical tests.
Accuracy: The GLUCOCARD Shine XL Blood Glucose
Monitoring System is calibrated to yield results equivalent
to plasma glucose concentrations. The accuracy of the
GLUCOCARD Shine XL System (Model GM505NA, GM505NB,
GM505NC) was tested by comparing blood glucose results
obtained by patients with those obtained using a YSI Model
2300 Glucose Analyzer, a lab instrument. The results below
were obtained by diabetic patients at clinic centers.
Obtained by healthcare
professionals
Obtained by lay users
Slope
1.023
1.032
Y-intercept
-1.86 mg/dL
-3.63 mg/dL
Correlation
coefficient(r)
0.995
0.985
Number of sample
110
105
Range tested
30–485 mg/dL
67– 413 mg/dL
Accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL
Within ± 10 mg/dL
Within ± 15 mg/dL
14/17 (82%)
17/17 (100%)
17/17 (100%)
Accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5%
Within ± 10%
Within ± 15%
Within ± 20%
54/93 (58%)
82/93 (88%)
93/93 (100%)
93/93 (100%)
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Precision: Precision studies were performed in a
laboratory using the GLUCOCARD Shine XL Blood
Glucose Monitoring System
Within Run Precision
Blood avg.
Blood avg.
Blood avg.
Blood avg.
Blood avg.
Total Precision
Control avg.
Control avg.
Control avg.
38mg/dL
86mg/dL
125 mg/dL
189 mg/dL
334 mg/dL
SD = 1.9 mg/dL
SD = 3.2 mg/dL
CV = 4.1%
CV = 2.6%
CV = 2.8%
35mg/dL
116 mg/dL
324 mg/dL
SD = 1.2 mg/dL
CV = 2.4%
CV = 2.3%
This study shows that there could be variation of up to 4.1%.
Alternate Sites Testing Evaluation
Comparison of results using various AST sites with the results
of YSI measurements.
• Alternate site test results for glucose concentration
< 75 mg/dL
Test site Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
Fingertip
Forearm
Palm
Thigh
Calf
1/2 (50.0%)
1/2 (50.0%)
2/2 (100%)
1/2 (50.0%)
1/2 (50.0%)
44 www.arkrayusa.com
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
2/2 (100%)
• Alternate site test results for glucose concentration
≥ 75 mg/dL
Test site Within ± 5% Within ± 10% Within ± 15%
46/48 (95.8%) 48/48 (100%)
42/48 (87.5%) 47/48 (97.9%)
38/48 (79.2%) 46/48 (95.8%)
36/48 (75.0%) 46/48 (95.8%)
46/48 (95.8%) 48/48 (100%)
Fingertip 27/48 (56.3%)
Forearm 19/48 (39.6%)
28/48 (58.3%)
Palm
17/48 (35.4%)
Thigh
27/48 (56.3%)
Calf
Within ± 20%
48/48 (100%)
48/48 (100%)
48/48 (100%)
48/48 (100%)
48/48 (100%)
www.arkrayusa.com 45
Warranty Information
Warranty
The manufacturer warrants that the GLUCOCARD Shine XL
Meter shall be free of defects in material and workmanship in
normal use for a period of 5 years.
The meter must have been subjected to normal use. The
warranty does not cover improper handling, tampering, use or
service of the meter.
Any claim must be made within the warranty period. The
manufacturer will, at its discretion, repair or replace a defective
meter, or meter part that is covered by this warranty.
As a matter of warranty policy, the manufacturer will not
reimburse the consumer’s purchase price.
Obtaining Warranty Service
To obtain warranty service, you must return the defective
meter or meter part along with proof of purchase.
Returns
For instructions on how to return your meter, contact
Customer Service: 800.566.8558, 24 hours a day, 7 days
a week, U.S.A. and Canada.
Meters returned without this authorization will not be accepted.
46 www.arkrayusa.com
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