Arkray Glucocard SHINE XL User manual

User Manual
For single user / home use only

DISTRIBUTED BY:
ARKRAY USA
5182 West 76th Street
Minneapolis, MN 55439 U.S.A.
800.566.8558
www.arkrayusa.com
Welcome to the GLUCOCARD® Shine XL
Blood Glucose Monitoring System
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 five seconds with a
small (0.5 µL) blood sample.
© All Rights Reserved.
P/N 5399-03 Rev. 01/21
PGK7E0172 Rev3 01/2021
Customer Service
800.566.8558
24 hours a day, 7 days a week. In case of emergency,
please contact your healthcare professional or
emergency medical response.

Table of Contents
Information
Important Information: Read This First_______________________________ 14
Important Health-related Information_________________________________ 15
Specifications______________________________________________________ 17
GLUCOCARD Shine XL Blood Glucose Monitoring System _____________ 19
Inserting or Replacing the Batteries _________________________________ 110
GLUCOCARD Shine Blood Glucose Test Strips _______________________ 111
Important Safety Instructions ______________________________________ 12
GLUCOCARD Shine XL Blood Glucose Meter__________________________ 14
GLUCOCARD Shine XL Blood Glucose Meter Display __________________ 15
Preparation
Setting Up the GLUCOCARD Shine XL System ________________________ 16
Adjusting the Date and Time _______________________________________ 16
Setting the Sound ‘On’/‘OFF’_______________________________________ 19
Checking the System _______________________________________________ 20
Control Solution Testing ___________________________________________ 21
Comparing the Control Solution Test Results ________________________ 23
Blood Glucose Testing
Using the Lancing Device ___________________________________________ 24
Preparing the Lancing Device ______________________________________ 25
Preparing the Meter and Test Strip__________________________________ 26
Flagging Post-meal Test Results ____________________________________ 27
Applying the Blood Sample ________________________________________ 28
Discarding Used Lancets __________________________________________ 30
Alternate Site Testing _______________________________________________ 31
‘HI’ and ‘Lo’ Messages______________________________________________ 34
Target Blood Glucose Ranges________________________________________ 35
Transferring Test Results ____________________________________________ 35
Additional Functions
Meter Memory _____________________________________________________ 36
Viewing Stored Test Results _______________________________________ 36
Setting the Alarm Function __________________________________________ 38
Setting the Post-meal Alarm (PP2 Alarm)____________________________ 38
Setting the Time Alarms (Alarm 1–3)________________________________ 39
Maintenance
Caring for the GLUCOCARD Shine XL System _________________________ 41
Understanding Errors and Other Messages ___________________________ 42
General Troubleshooting ____________________________________________ 44
Performance Characteristics_________________________________________ 45
Warranty Information _______________________________________________ 48

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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 steady-
state 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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• 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. In case of
emergency, please contact your healthcare professional or
emergency medical response.
Important Health-related Information

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Important Health-related Information
This device is not intended for use in healthcare or assisted-
use settings such as hospitals, physician offices or long-term
care facilities because it has not been cleared by the FDA for
use in these settings, including for routine assisted testing or
as part of glycemic control procedures.
Use of this device on multiple patients may lead to the
transmission of Human Immunodeficiency Virus (HIV),
Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other
bloodborne pathogens.

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Specifications
Product Specifications
Measurement range 20–600 mg/dL
Sample size Minimum 0.5 μL
Test time Five 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 250 test results
Size 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 50–104 ºF (10–40 ºC)
Relative humidity 10–90 %
Hematocrit 20–60 %

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Specifications
Storage/Transport Conditions
Temperature Glucose Meter
(with batteries)
32–122 ºF (0–50 ºC)
Test strip 34–86 ºF (1–30 ºC)
Control solution 46–86 ºF (8–30 ºC)
Relative humidity Test strip 20–80 %

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GLUCOCARD Shine XL Blood Glucose
Monitoring System
GLUCOCARD Shine XL Blood Glucose Monitoring
System 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 Test Strips and 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.

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• 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.
• When the symbol appears on the display while the meter
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.
Inserting or Replacing the Batteries
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 16–19.

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Insert
GLUCOCARD Shine Blood Glucose Test Strips
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.
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 34–86 ºF (1–30 ºC).
• 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.
• Avoid getting any liquid or moisture in the test strip vial.
This can affect the test strips and cause inaccurate test
results.
• Do not apply samples other than capillary whole blood or
control solution to the test strip.
• 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.

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• 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.
NOTE
• You can get more safety information at FDA Public Health
Notification (http://wayback.archive-it.org/7993/20170111013014/
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.htm) or at CDC Clinical Reminder (http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html).
CAUTION
Do not allow any foreign substances or liquid substances, such
as dirt, blood, or water, enter into the meter. The meter may be
damaged or may malfunction. Follow the warning information
provided below to prevent possible damage to the meter.
• Do not apply the blood or control solution samples directly
to the test strip port.
• Do not apply the blood or control solution samples to the
test strip while holding the meter in a way that the tip of
the test strip faces upwards. The blood or control solution
samples may run down the surface of the test strip and flow
into the test strip port.
• Do not store your meter in unsanitary or contaminated sites.
• Make sure to follow the procedures found in the Caring
for the GLUCOCARD Shine XL System section of this user
manual.

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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.
GLUCOCARD Shine XL Blood Glucose Meter
Data Port
Used to transfer data
from the meter to a
computer with
a cable
<Button
Turns the meter
on and selects
or changes
information
Display
Shows results
and messages
Test Strip Port
Insert test strip here
>Button
Selects or
changes
information
Button
Turns the meter
on/off and confirms
menu selections

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NOTE
• The unit of measurement for your GLUCOCARD Shine XL
Meter is preset and fixed in mg/dL.
mem
appears when test
results stored in
the memory are
displayed
alarm
appears when
the time alarm
has been set
Battery symbol
indicates meter
batteries are running
low and need to
be replaced
Post-meal test mark
appears during post-
meal testing and
when post-meal test
results are displayed
Alarm symbol
appears when the
post-meal alarm
has been set
Mute symbol
appears only when
the sound is set
to ‘OFF’
check
appears when the
control solution test
results are saved or
displayed
Test results
test results
display panel
mg/dL
unit for measuring
blood glucose
Blood insertion
symbol
indicates meter
is ready for the
application of a
drop of blood or
control solution
GLUCOCARD Shine XL Blood Glucose Meter Display
Date Time

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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.
Press and hold the button for three seconds to enter the
‘SET’ 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 hold the button for three seconds again.
Adjusting the Date and Time
Step 1 Entering the SET Mode
Press and hold the button for three 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
faster. After setting the year, press the button
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.
Press the button to confirm the selection
and progress to the next step.
Step 4 Setting the Date
Press the < or > button until blinking number
shows the correct date. Press the button to
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
the format, press the button to progress to
the next step.

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Step 6 Setting the Hour
Press the < or > button until the correct hour
appears. Press the button to confirm the hour
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
the button to progress to the next step.

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Step 8
On pressing the < or > button, the screen will
display ‘On’ or ‘OFF’. Press the button to
confirm the selection. The meter will beep in
the following instances if set to ‘On’.
• When the or <button is pushed to turn
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
Setting the Sound ‘On’/‘OFF’
NOTE
• symbol is displayed only when the sound is set to ‘OFF’.
• At any stage, if the button is pressed for three seconds,
time and date will be saved, and the meter will be turned off.
• Press and hold the > button to scroll through numbers
quickly.
If the sound is set to ‘OFF’, none of the sound functions
will work.
After setting the sound, press and hold the button for
three seconds to save all settings and turn off the meter.

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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 21.
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 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 (68–77 ºF, 20–25 ºC).
• Before using the control solution, shake the bottle, discard
the first one or two drops and wipe the tip clean.
• Close the control solution bottle tightly and store at a
temperature between 46–86 ºF (8–30 ºC).