Accu-Chek 98/79/EC User manual

This product fulfills the requirements of Directive
98/79/EC on in vitro diagnostic medical devices.

Welcome
Thank you for selecting the Accu-Chek®Sensor
System. Designed for ease of use, this system was
produced in close association with diabetes health-
care professionals, hospitals and, most importantly,
people with diabetes.
The Accu-Chek Sensor System is intended for
self-testing of glucose in capillary whole blood by
persons with diabetes.
The lightweight, portable meter provides accurate
results in seconds. When you dose the test strip,
the meter measures your blood glucose level and
displays your result. It’s that simple.
Before using your Accu-Chek Sensor Meter or
Accu-Chek®Softclix Lancet Device for the first
time, please refer to the Quick Reference Guide
included in this pack. Should you require further
information, please study this user’s manual.
Please forward your completed warranty card
immediately to Roche Diagnostics.
If you have any questions or inquiries, please call
Roche Diagnostics.
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Contents
About the Accu-Chek Sensor Meter . . . . . .v
Special Features . . . . . . . . . . . . . . . . . . . .vii
About the Accu-Chek Sensor Comfort
Test Strip . . . . . . . . . . . . . . . . . . . . . . . . .viii
Inserting the Battery . . . . . . . . . . . . . . . . . .1
Battery Symbol on the Display . . . . . . . . . .2
Setting the Beeper, Time, Date, Year,
and Hypo Flag . . . . . . . . . . . . . . . . . . . . . . .4
Turning the Beeper On or Off . . . . . . . . . . .4
Setting the Time, Date and Year . . . . . . . . .6
Setting the Hypo Flag . . . . . . . . . . . . . . . .8
Coding/Calibrating Your Meter . . . . . . . . . .9
Testing . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Gathering Supplies . . . . . . . . . . . . . . . . .11
Performing a Test . . . . . . . . . . . . . . . . . .11
Marking a Result with a Flag, Asterisk ( ) . .16
Understanding Your Test Results . . . . . . .17
Do’s and Don’ts . . . . . . . . . . . . . . . . . . . .18
Proper Test Strip Appearance . . . . . . . . . .19
Using Memory . . . . . . . . . . . . . . . . . . . . . .20
Quality Control Checks . . . . . . . . . . . . . . .22
Performing a Quality Control Check . . . . .24
Understanding Control Results . . . . . . . . .27
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Caring for Your Meter . . . . . . . . . . . . . . . .28
Display Check . . . . . . . . . . . . . . . . . . . . .28
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . .28
Storage and Handling . . . . . . . . . . . . . . .29
Note to Healthcare Professionals . . . . . . .30
Transferring Data . . . . . . . . . . . . . . . . . . .31
Quick Reference Display Guide . . . . . . . . .32
Memory Displays . . . . . . . . . . . . . . . . . . .34
Display Messages . . . . . . . . . . . . . . . . . . .36
Battery Displays . . . . . . . . . . . . . . . . . . .36
Quality Control Check Displays . . . . . . . . .37
Error Messages . . . . . . . . . . . . . . . . . . . . .39
Technical Data . . . . . . . . . . . . . . . . . . . . .42
Product Specifications . . . . . . . . . . . . . . .43
Product Safety Information . . . . . . . . . . . .45
Warranty and Service Instructions . . . . . .46
Supplies and Accessories . . . . . . . . . . . . .47
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
Any Questions . . . . . . . . . . . . . . . . . . . . . .51
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About the Accu-Chek® Sensor Meter
Display
Shows blood
glucose result,
messages, and
glucose results
stored in
memory.
ON/OFF Button
Press to turn
meter ON or OFF.
Right and Left
Buttons
Used for meter
setup and review
of memory.
Serial Port
Used to transfer
data.
Test Strip Slot
Insert test
strip here.

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About the Accu-Chek Sensor Meter
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731
Code Key
For coding/
calibrating
your meter.
New code key
comes with every
vial of test strips.
Battery Cover
Remove cover to
change battery.
Code Key Slot
Insert code key
here.

Special Features
Your meter is designed to store information
important to you and your healthcare
professional. The memory will store 480
readings.
Along with these readings, the meter can store
additional important information. The hypo flag
allows you to define your hypoglycemic level
and receive a reminder whenever you obtain a
blood sugar result below this level. See page 8
for additional information.
The meter also has a flag, or asterisk (*), that
you can save in the memory with your blood
sugar result. See page 16 for additional
information on this feature.
The meter will also calculate 7, 14, and 30-day
averages. You do not have to set the time and
date for the meter to give you average calcula-
tions. See page 20 for specific information on
averages.
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About the Accu-Chek®Sensor Comfort
Test Strip
Electrodes
Insert strip with silver-coloured bars up
and toward the meter.
Yellow Window
Do not apply blood on the top of
the test strip.
Before Applying Blood –
This window should be completely
yellow.
After Applying Blood –
This window should be completely filled
with the blood drop.
Note: Any area of the strip can be
touched and the glucose reading will not
be affected.
Comfort Curve
Touch drop of blood here,
to the edge of the strip.

Inserting the Battery
Your meter is shipped with one 3-volt battery type 2032
(CR 2032, DL 2032, or equivalent) that needs to be
inserted before testing. The battery that comes with your
meter can be found in the mesh pocket of your carrying
case. Battery life will vary depending on usage, so
always keep a spare on hand.
The meter saves battery power by automatically turning
off after 90 seconds of non-use or 5 seconds after
taking a strip out of the meter following a test. If the
meter does automatically shut off, all tests in memory
are saved.
Note: After changing the battery, your meter will
prompt you to verify the time and date immediately
after the battery is inserted. This occurs only if the
time and date had been set previously on your
meter.
1. Push the recessed plastic
tab of the battery
compartment forward
(toward the arrow) to flip
open the battery door.
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2. Insert the 3-volt battery
(type 2032) into the
compartment with “+”
side facing you.
3. Snap battery cover back in
place. If time and date
feature was set previously,
the meter will turn on
automatically. Confirm that
the time and date are set
correctly. If time and date have not been set
previously, wait 5 seconds, then turn meter ON. The
meter beeps if the beeper is turned on.
Battery Symbol on the Display
When a battery symbol
appears on the display, your
battery is weak and has only
enough power to run a few
more tests. Although the meter
will still provide accurate
results, you need to replace
the battery as soon as possible.
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+
Battery is low.

If a flashing battery symbol
appears on the display, the
battery is nearly dead.
After changing the battery, your meter will prompt you to
verify the time and date immediately after the battery is
inserted, if time and date had previously been set. See
Setting the Time, Date and Year on page 6.
Note: To retain the correct time and date settings, you
will need to replace the battery before it is completely
dead.
Please dispose of meter battery according to your local
ordinances.
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Battery must be replaced
to continue testing.
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Setting the Beeper, Time, Date, Year,
and Hypo Flag
Turning the Beeper On or Off
Does the beeperhave to be turned on?
No, it is an optional feature. Turning the beeper on or
off does not affect the test results. If the beeper is
turned off, beeps that occur due to errors will still
sound.
The meter is set to beep when:
• A strip is inserted
• Blood or control solution is applied to strip
• A result is displayed
• An error occurs while testing
• Buttons are pushed
• Battery is installed
If you do not want the beeper on, turn it off by following
these steps:
1. Press and release the ON/OFF button to turn the
meter ON.
2. Wait until the strip icon
flashes or code and
“---” appear before
proceeding to step 3.
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3. Press and hold down the ON/OFF button until “set”
appears at the bottom of the screen. Release the
ON/OFF button.
“On,” “set,” and the
flashing beeper symbol
appear on the display.
The beeper is now on.
Note: You may leave the set mode at any time by
pressing and holding the ON/OFF button. The
settings you have entered will be saved.
4. Press and release the right
or left arrow button.
“OFF,” “set,” and the
beeper symbol appear on
the display. The beeper
is now off. To turn beeper
back on, simply press and
release the right or left
arrow button again.
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5. Press and hold down the
ON/OFF button until strip
icon is seen flashing or
code and “---” appear to
leave this function.
Setting the Time, Date and Year
Do I have to set the time and date?
Time and date should be set prior to testing if you plan
to download the results into software or if you plan to
review your memory to check when a test was done.
To set the time, date and year:
1. Press and release the
ON/OFF button to turn the
meter ON.
2. Wait until the strip icon
flashes or code and “---”
appear before proceeding
to step 3.
3. Press and hold down the
ON/OFF button until “set”
appears at the bottom of
the screen. Release the
ON/OFF button.
4. Press and release the
ON/OFF button to confirm beeper setting and move
to set the time.
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5. Press and release the ON/OFF button. The hour
display flashes.
6. Press and release the right or left arrow button until
the correct hour is displayed.
7. Press and release the ON/OFF button. The minute
display flashes.
8. Press and release the right or left arrow button until
the correct minute is displayed.
9. Press and release the ON/OFF button. The month
display flashes.
10. Press and release the right or left arrow button until
the correct month is displayed.
11. Press and release the ON/OFF button. The day
display flashes.
12. Press and release the right or left arrow button until
the correct day is displayed.
13. Press and release the ON/OFF button. The year
display flashes.
14. Press and release the right or left arrow button until
the correct year is displayed.
15. To leave this function, press and hold down the
ON/OFF button until the flashing strip symbol or
code and “---” are displayed.
Note: You may leave the set mode at any time by
pressing and holding the ON/OFF button. The
settings you have entered will be saved.
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Setting the Hypo Flag
T he hypo flag allows you to define your hypoglycemic
level and receive a reminder whenever you obtain a
blood sugar result below this level. You can set the hypo
indicator level to any number between 60 and 80 mg/dL
(3,3 and 4,4 mmol/L).
Important Note: Consult with your healthcare professional
to set the hypo marker to compliment your therapy. Do not
use the hypo marker as the only indicator of hypoglycemia.
Rely upon your symptoms and directions from your
healthcare professional.
To set the hypo flag:
1. Press the ON/OFF button to turn the meter on.
2. Wait until the strip icon or code and “---” flash
before proceeding to step 3.
3. Press and hold down the ON/OFF button until “set”
appears at the bottom of the screen. Release the
ON/OFF button.
4. Repeatedly press and release the ON/OFF button
until “hypo” flashes and “OFF” and “set” appear on
the display.
Note: the meter is factory set with the hypo flag in
the off position.
5. Press and release the right or left arrow button to
turn ON the hypo flag.
6. Briefly press and release the ON/OFF button. “Hypo”
flashes, and the current hypo indicator setting, “set,”
“mg/dL” or “mmol/L” appear on the display.
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7. Press and release the right or left arrow button to
adjust the hypo flag setting.
8. To leave this function, press and hold down the
ON/OFF button until the flashing strip symbol or
code and “---” are displayed.
Coding/Calibrating Your Meter
What is coding/calibrating, and when is it necessary?
Before you use your meter for the first time and
every time you open a new box of test strips, you
need to set the meter to “match” the strips. This is
called coding/calibrating.
To ensure accuracy of your blood glucose
monitoring system, you must change your code key
with each new box of test strips. Each code key
provides your meter with the specific information
that your meter needs to accurately measure your
blood glucose. Do not use code keys with your
Accu-Chek Sensor Meter from any test strip
manufacturer or system other than the Accu-Chek
Sensor System from Roche Diagnostics. Use of other
manufacturers’ code keys may result in erroneous
results with your system.
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A code key is properly inserted when it snaps into place.
You will need to insert a new code key:
• Whenever you open a new box of strips.
• Whenever either one of these displays appear:
1. Make sure meter is turned off. Turn meter over so
you are looking at the back. Remove old code key if
one is installed.
2. Insert new code key until it snaps into place.
3. Turn meter ON. A 3-digit code number appears. This
number must match the code number on your vial
of test strips. If it does not, repeat steps 1–3.
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