Arkray Glucocard X-Meter Operator's manual

USER INSTRUCTION MANUAL

CAUTION: Before using any product to test your blood sugar (blood
glucose), read all instructions and practice the test. Do all quality
control checks as directed and consult with a diabetes healthcare
professional. These recommendations apply to all blood glucose
monitoring systems and are supported by the American Association
of Diabetes Educators, the American Diabetes Association, the U.S.
Food and Drug Administration, and the Health Industry Manufacturers
Association.
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Intended Use ...............................................6
Understanding the GLUCOCARD™ X-METER. . . . . . . . . . . . . . . . . . . . . . . . 7
Changing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Meter Set-up .................................................13
Basic Rules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Audible Beep ...........................................16
Year ...................................................18
Month/Day .............................................19
Hour/Minute ............................................20
Test Averaging ..........................................21
Data Download Baud Rate ...............................22
Ending Set-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Performing a Control Solution Test ...............................23
Troubleshooting Control Solution Test .......................30
TABLE OF CONTENTS
3

Thank you for choosing the GLUCOCARD™ X-METER. This system
measures blood glucose in fresh capillary whole blood. Results are
shown as plasma values. This makes it easy to compare the
GLUCOCARD™ X-METER and lab results.
Please read this manual before using the system. If you have any
questions, call Customer Service at 800.566.8558 (24 hours a day, 7 days
a week, USA and Canada only). Contact your healthcare professional
with questions if you are unable to reach Customer Service.
Blood Glucose Testing .........................................33
The Lancing Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Getting a Drop of Blood .....................................35
Performing a Blood Glucose Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Flagging Test Results ........................................42
Alternate Site Testing (AST). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Understanding Test Results ...................................53
Recalling Results - Entering Memory Mode ........................58
Maintenance.................................................62
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Storage and Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Display Screen and Error Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Product Information ...........................................69
Product Specifications ......................................69
Warnings, Precautions & Limitations ...........................70
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
INTRODUCTION
54

76
Intended Use
The GLUCOCARD™ X-METER is intended for the quantitative
measurement of glucose in fresh capillary whole blood samples drawn
from the fingertips, forearm, upper arm, or palm. Testing is done
outside the body (In Vitro diagnostic use). It is indicated for use at
home (over the counter [OTC]) by persons with diabetes, or in clinical
settings by healthcare professionals, as an aid to monitor the
effectiveness of diabetes control.
The System Includes:
•Meter•CarryingCase•UserInstructionManual•QuickReferenceGuide•Self-testingLogbook•MayalsoincludeTestStrips,ControlSolution, and Lancing Device and/or
Lancets Carrying Case
Control Solution
UNDERSTANDING THE GLUCOCARD™ X-METER
Bottom Battery
Compartment
Cover
Display
Connection
Terminal
Test Strip
Port
Orange/Up
Arrow
Gray/Down
Arrow
Top
Tab

Memory Mode Symbol
Battery Symbol
Apply Blood Symbol
Temperature Warning
Audible Beep Off
Unit of Measurement
Time Format
Delete Symbol Control Solution
NOTE: Meters in the USA are programmed to show results in mg/dL. Meters
used outside the USA are programmed to show results in either mg/dL or
mmol/L. Results displayed in mmol/L will always have a decimal point.
Results displayed in mg/dL will never have a decimal point.
98
Date
Explanation of the full display screen: GLUCOCARD™ X-SENSOR
These test strips need only 0.3 µL (microliter) of blood. Apply blood to the
sample application tip. The strip draws in the blood by capillary action.
The blood glucose reacts with the enzyme on the test strip. This produces
a current proportional to the blood glucose level. The meter detects the
current and converts it into a blood glucose reading.
Code No.
(F-2, 3 or 4)
Expiration date
F- 4
7
Test Strip Bottle
Front Back
Test Strip
Sample
Application Tip
(Apply blood
to end of test
strip. Capillary
draw will pull
blood to
reaction site).
Code No.
(F-2, 3 or 4) Contact
Bars
Insert
this way
into
meter

1110
CAUTION: Replacing the battery will not delete meter settings or test
results stored in the meter unless you:
•Touchthemetalportiononmainunitwithyourngersoranymetal.•Takeover5minutestoreplacebattery.•Loadthebatteryincorrectly.•Loadausedorweakbattery.Changing the Battery
The GLUCOCARD™ X-METER comes with one lithium battery CR2032 (or DL2032).
WARNING: Keep all batteries out of children’s reach. If a battery is
swallowed, consult a doctor immediately.
NOTE:
•Tosavebatterypower,themeterturnsitselfoff3–5minutesafterlastuse.•Replacebatterieswhenlowbatterysymbolappears.Otherwiseinaccurate results could be obtained.
•Discardusedbatteriesasperlocalguidelines.To replace battery:
1. Open the battery cover on the back
side of the meter by pushing the tab
in the direction of the arrow and pulling
the cover up.
2. The battery is held in place on the
underside of the cover. Slide the
battery out of the cover.
3. Load a new battery into the battery
cover. Place the “+” side down when
loading the battery into the cover.
4. Make sure the battery is loaded in the
proper position. Otherwise, the
preprogrammed times will be reset.
CAUTION: Do not touch the metal contacts inside the battery
compartment with your finger or any metal.

5. Put the battery cover back into the correct position and snap to
close.
If the clock setting has been deleted, either “12:00” or “0:00” will
blink when you put a test strip into the meter. The low battery
symbol means you need to replace the battery as soon as
possible. Discard used batteries as per local guidelines.
1312
Before using the GLUCOCARD™ X-METER for the first time, set the time and
date. Do not perform a blood glucose test until you have set-up the meter.
Meter set-up allows you to adjust the audible beep volume and to set time,
date, test averaging, and data download baud rate.
Basic rules for meter set-up:
Step 1: Enter meter set-up by first
making sure the meter is turned off.
METER SET-UP
Orange/Up
Arrow
Gray/Down
Arrow

Step 2: Press the Orange/Up Arrow and Gray/
Down Arrow buttons at the same time for 5
seconds. A beep sounds and the meter turns
on. Next, a second beep sounds and “SET”
shows on the screen.
1514
Step 3: Use the Orange/Up Arrow to change the set-up screen. When
you press the Orange/Up Arrow, the set-up screen changes in the order
shown in the diagram to the right. Press the Gray/Down Arrow button to
change a setting within a set-up screen menu.
Note: If you need to go back to a setting, you must scroll through
each set-up option. You cannot go backwards in set-up mode.
In set-up mode, the meter will turn off automatically after 3 minutes
of non-use.
<Power OFF>
Gray Arrow
Setting
the
Audible
Beep
1
Ending
Set-up
9
Setting
the Year
2
Setting the
Data
Download
Baud Rate
8
Orange
Arrow
Orange
Arrow
Orange
Arrow
Orange
Arrow
Orange
Arrow
Orange
Arrow
Return
Setting the
Hour
5
Setting the
Day
4
Setting
the
Minute
6
Setting the
Month
3
Setting
Test
Averaging
7
Orange
Arrow
Orange
Arrow
Orange
Arrow
Orange
Arrow

1716
Setting the Audible Beep
If the audible beep is turned “on”, the beep will sound when:
•Youinsertateststripintothemeter.•Youapplybloodorcontrolsolutiontoateststrip.•Thetesthasendedandtheresultisdisplayed.•Themeteristurnedon,butyoudonotuseitforseveralminutes.Meterwill beep and automatically shut off.
•YougointoMemoryMode.Make sure the meter is off. Press the Orange/Up
Arrow and Gray/Down Arrow buttons at the same
time for 5 seconds. A beep sounds and the meter
turns on. Next, a second beep sounds and “SET”
shows on the screen.
Press the Orange/Up Arrow button. The screen will
display “bUZ” and the current beep setting.
Beep
Press the Gray/Down Arrow button to
cycle through the volume levels:
“OFF” (no sound)
”on 1” (low)
“on 2”(middle)
“on 3” (high)
“OFF” (no sound) …, etc.
A beep sounds at the set volume
at each step. If “OFF” is set, the
“audible beep mute (Off)” symbol
lights up in the upper right of the
screen. After you select the beep
volume, press the Orange/Up Arrow
button to confirm the setting. The
screen changes to the year
set-up screen.
Beep
Beep
Beep
[1]
[1]
[1]
[1]

1918
Setting the Year
In the year set-up screen, the last two digits of the
currently set year appear at the top of the screen.
“yER” appears in the middle of the screen. All four
digits of the currently set year appear at the
bottom of the screen. The last two digits will blink.
Press the Gray/Down Arrow to change the last
two digits of the year to the correct year. After you
set the year, press the Orange/Up Arrow button to
confirm the setting. The screen changes to the
month set-up screen.
[1]
[2]
[3]
Setting the Month
Press the Gray/Down Arrow button to change the
month. After you set the month, press the Orange/Up
Arrow button to confirm the setting. The screen
changes to the day set-up screen.
Setting the Day
Press the Gray/Down Arrow button to change the day.
After you set the day, press the Orange/Up Arrow
button to confirm the setting. The screen changes
to the hour set-up screen.
[1]
[2]
[3]
[4]

2120
Setting the Hour
Press the Gray/Down Arrow button to change the hour.
After you set the hour, press the Orange/Up Arrow
button to confirm the setting. The screen changes to
the minute set-up screen.
Setting the Minute
Press the Gray/Down Arrow button to change the
minute. After you set the minute, press the Orange/Up
Arrow button to confirm the setting. The screen
changes to the test averaging set-up screen.
[1]
[2]
[3]
[4]
NOTE: “Lo” results are included as 20 mg/dL in the averages. “Hi”
results are included as 600 mg/dL in the averages.
Setting Test Averaging
Press the Gray/Down Arrow button to cycle through the test averaging
choices: “oFF” (not displayed), “14” (14-day
average), or“30” (30-day average).“AVE”
appears near the middle of the screen.
If you select either 14-day or 30-day averaging,
your average test result will appear when you
recall results from memory. See page 58.
After you set test averaging, press the
Orange/Up Arrow button to confirm the
setting. The display changes to the data
download baud rate set-up screen.

2322
Setting the Data Download Baud Rate
The baud rate needs to be set to download data. Data download
requires a custom cable. Data management software and download
cables are available by calling 1-800-566-8558. Press the Orange/Up
Arrow button to continue with set-up.
Ending Set-up
To make further changes to set-up settings, press
the Gray/Down Arrow button while “End” is
displayed. This will bring up the Audible Beep
set-up screen. You can then move through the
set-up mode and adjust any settings that you wish.
If you are done with set-up, press the Orange/Up
Arrow button while “End” is displayed. This
confirms all settings and turns the meter off.
The meter will turn off automatically 3 minutes after “End” is displayed.
<Power OFF>
Beep
Use GLUCOCARD™ X-METER CONTROL to check if:
•themeterandteststripsareworkingcorrectlyasasystem.•youaretestingcorrectly.Call your local supplier or pharmacy to order control solution. If they do
not stock it, call ARKRAY Order Services at 800.818.8877 option 4 (USA
and Canada only).
PERFORM A CONTROL SOLUTION TEST

2524
Perform a Control Solution Test:
•BeforetestingwiththeGLUCOCARD™X-METERforthersttime.•Whenyouopenanewbottleofteststrips.•Wheneveryoususpectthemeterorteststripsmaynotbefunctioningproperly.
•Iftestresultsappeartobeabnormallyhighorloworarenotconsistentwith clinical symptoms.
•Theteststripbottlehasbeenleftopenorhasbeenexposedtotemperatures below 34°F (1°C) or above 86°F (30°C), or humidity levels
above 80%.
•Tocheckyourtechnique.•WhentheGLUCOCARD™X-METERhasbeendroppedorstoredbelow32°F (0°C) or above 122°F (50°C).
Important:
•UseonlywithGLUCOCARD™X-METERandGLUCOCARD™X-SENSORBlood Glucose Test Strips.
•GLUCOCARD™X-METERCONTROLisnotintendedforhumanconsumption. Do not drink. •Donotapplytoeye.Contactyourhealthcareprofessionalimmediately if solution is swallowed, injected, or applied to the eye.
•Dyeincontrolsolutionmaystainskin,clothing,orsurfaces.•Storethecontrolsolutionbetween34-86°F(1-30°C).Keepawayfromdirect sunlight, flourescent light, and heat. Do not freeze.
•Usebeforetheexpirationdateprintedonbottle.•Usethecontrolsolutionwithin3monthsofrstopening.Itisrecommended that you write the date of opening on the control
solution bottle label (OPEN DATE) as a reminder to dispose of the
opened solution after 3 months.
•Alwaysreplacethecapimmediatelyafteruse.•GLUCOCARD™X-METERCONTROLisnotacleaningsolution.Donotclean your GLUCOCARD™ X-METER with GLUCOCARD™ X-METER
CONTROL.
•Donotusethecontrolsolutionwhenthesolutionlevelfallsbelowthe bottom edge of the label on the bottle.
•UsetheControlSolutionbetween72-82°F(22-28°C).

2726
Step 1: Insert a test strip as shown in diagram. Test strip should seat firmly
into meter. The meter will turn on automatically. The full screen will come
on for a moment. Make sure all symbols appear on the screen (see
page 8). Then the code number (F-2, F-3, or F-4) will appear and will
alternate with the Apply Blood symbol. Make sure that the code
number on the screen matches the code number on the test strip
bottle. If screen code does not match the test strip code, use a new test
strip. If code still does not match, use a new bottle of test strips or call
Customer Service at 800.566.8558 (24 hours a day, 7 days a week, USA
and Canada only).
Step 2: Press the
Orange/Up Arrow
button to enter the
control mode. You
will see “CONT” on
the bottom right of
the screen.
If you do not enter
the control solution
mode, the control
solution result will
NOT be valid.
Orange/Up
Arrow
Gray/Down
Arrow

2928
Step 3: Mix control solution by gently
inverting bottle. Remove the cap from the
control solution bottle. While the
Apply Blood symbol and Code No.
(F-2, F-3 or F-4) are alternating, place
a drop of the control solution on the
end of the test strip.DO NOT put control
solution on top of the test strip. The test
strip will draw up the solution and the
meter will beep. The meter will begin to
count down.
Step 4: In 5 seconds the meter will
beep again and display the control
solution result.Compare the result to
the range printed on the test strip bottle.
Make sure the result is within the
acceptable range. If the result falls
within this range, the meter and test
strip are working correctly. NOTE: Control solution test results are not included in the averages.
Do not use the system if control solution result is out of range. See
Troubleshooting Control Solution Test (page 30).
Result is automatically stored in memory. See page 42 for additional
information
Step 5: Remove test strip. Dispose of the used test strip.
Control solutions are available in three (3) levels - Low (L), Normal (N),
and High (H).
Repeat Steps 1-5 with other Control Solution levels as per
recommendations of your healthcare professional.
Call your local supplier or pharmacy to order control solution. If they do
not stock it, call ARKRAY Order Services at 800.818.8877 option 4 (USA
and Canada only).

3130
Troubleshooting Control Solution Test
If the control solution test result is out-of-range, check the following and repeat the test:
Check Action
Did you do the test in If not, do the test again. Insert a
control solution mode? test strip; press the Orange/Up Arrow
Do you see “CONT” on button for control solution mode.
the screen with the result? “CONT” should appear on screen.
Have the test strips and/or Make sure that test strips and control
control solution expired? solutions are not past expiration date.
This date is shown on bottle.
Were control solutions at room If not, retest with new bottle
temperature (72-82°F (22-28°C)) of control solution, or warm up/cool
when used? down to room temperature.
Does the code on the test strip If not, obtain a new bottle
bottle match the code on of test strips.
the meter screen?
Check Action
Did you insert test strip Make sure test strip is inserted
firmly into meter? all the way into test strip port.
See diagram on page 26.
Did you follow the Reread “Performing a Control
procedure correctly? Solution Test” (pages 24-29) and retest.
Were test strips stored correctly If not, retest with a
(between 34-86°F (1-30°C))? new bottle of test strips.
Was the bottle cap replaced
immediately after removing
a test strip?
Is the meter damaged? If yes, contact Customer Service at
Does it show an error code? 800.566.8558.

3332
Does your Control Solution result still read outside the range
printed on the test strip bottle? If yes, the system may not be
working correctly. DO NOT USE the system to test your blood
glucose until the control solution result is within range. If you
need help, please call Customer Service at 800.566.8558
(24 hours a day, 7 days a week, USA and Canada). Contact
your diabetes healthcare professional if you cannot reach
Customer Service.
The Lancing Device
NOTE: Do not use the lancet if the cap is missing or damaged.
BLOOD GLUCOSE TESTING
Multilet (lancet)
Disposal-and-set
lever
Removable cap
Multi-Lancet Device™body
Lancing Button Adjustment dial
Band hooks
Strap hole
Special band
Protective cap
Groove of special band
Step 1: Pull the
removable
cap to
remove it.

34 35
Step 3: Twist off the protective cap.
Step 4: Attach the removable cap.
Step 2: Insert a new, unused lancet into the
Holder until it stops.
Holder
Step 5: The Multi-Lancet Device offers 7 different levels of skin
penetration. For soft or thin skin or first time use, select “1 or 2.” For
alternate sites, select “7.” If the obtained amount of blood is excessive,
turn the dial to a lower setting. If the obtained amount of blood is
insufficient, turn the dial to a larger setting.
1 2 3 4 5 6 7
Deeper
Level indications

36 37
Step 5: Set aside the lancing device and wait a few seconds for a
blood drop to form. Keeping the hand warm, lowering the hand to
waist level and gently massaging your wrist, palm or the base of the
finger helps the flow of blood. Use a different site each time you test to
help prevent soreness and calluses.
NOTE: A lancet should only be used once. Dispose of used lancet in a
safe manner so as not to cause accidental injury.
WARNING: DO NOT share used lancets with another person. To prevent
possible infection, a used lancet should not be touched by another
person.
Step 4: Press the removable
cap to the side of the
fingertip. Press the lancing
device button.
Getting a Drop of Blood
Step 1: Wash hands with soap and warm water. Dry
hands thoroughly. If you use alcohol wipes to cleanse
fingers, make sure the area is dry before lancing finger.
Residual alcohol may lead to inaccurate readings.
Step 2: Let the arm hang down for 10 to 15 seconds.
(Holding the arm below the heart and massaging
the wrist, palm and finger makes it easier to obtain
a blood drop).
Step 3: Choose a site on the side of a fingertip to minimize pain.

38
Performing a Blood Glucose Test
Step 1: Remove test strip
from the bottle. Immediately
replace the bottle cap
tightly. Insert test strip as
shown in diagram. A beep
will sound and the meter will
turn on automatically. Verify
that all symbols appear on
the screen.
39
NOTE: Four and a half minutes after test strip insertion, a beep sounds
every 5 seconds. After 5 minutes, a beep sounds and the meter turns
off. Take out unused test strip and insert it again to turn meter back on.
Step 2: The beep will sound again. The Apply Blood symbol and the
code number (F-2, F-3, or F-4) will alternate on the screen. Verify that
the code number on the screen matches the code number printed on
the bottle. If the code number does not match, the meter may give a
false reading. If code does not match, use a new strip. If code still does
not match, use a new bottle of test strips or call Customer Service at
800.566.8558 (24 hours a day, 7 days a week, USA and Canada only).
Verify that the date and time appear on the screen and are correct. If
date and time are not correct, reset them (see Meter Set-up, page 13).
Code No.
(F-2, 3 or 4)
Expiration date
F- 4
7