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
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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
4

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.
INTRODUCTION
5

6
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

7
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.
8
Date
Explanation of the full display screen:

9
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

10
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.

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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.
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13
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.
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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.

15
<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

16
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

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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]

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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]

19
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]

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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]