Accu-Chek Aviva User manual

Owner’s Booklet for Self-Testing Only
Blood Glucose Meter
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Roche USA –51515
V4/1 – 05958083003 – Black
Roche USA –51515
V4/2 – 05958083003 – Cyan
Roche USA –51515
V4/3 – 05958083003 – Magenta
Roche USA –51515
V4/4 – 05958083003 – Yellow
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ACCU‑CHEK, ACCU‑CHEK AVIVA, and FASTCLIX are trademarks of Roche.
All other product names and trademarks are the property of their respective owners.
©2013 Roche Diagnostics 05958083003‑1212
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
www.accu‑chek.com
Table of Contents
Important Safety Information .............................................................................................. 1
Chapter 1: Your New System .............................................................................................. 5
Chapter 2: Control Tests .................................................................................................... 12
Chapter 3: The ACCU‑CHEK FastClix Lancing Device ......................................................... 17
Chapter 4: Blood Glucose Tests ......................................................................................... 21
Chapter 5: Meter Memory, Setup, and Data Transfer ......................................................... 27
Chapter 6: Meter and Lancing Device Cleaning and Disinfecting....................................... 34
Chapter 7: Maintenance and Troubleshooting ................................................................... 39
Chapter 8: Technical Information ...................................................................................... 43
Index ................................................................................................................................ 48
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1
Important Safety Information
WARNING
Choking hazard. Small parts. Keep away from children under the age of 3years.
The ACCU-CHEK Aviva Plus System
The ACCU‑CHEK Aviva Plus blood glucose monitoring system is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm,
upper arm, or palm. The ACCU‑CHEK Aviva Plus blood glucose monitoring system is intended to be used by a
single person and should not be shared.
The ACCU‑CHEK Aviva Plus blood glucose monitoring system is intended for self‑testing outside the body (in
vitro diagnostic use) by people with diabetes at home as an aid to monitor the eectiveness of diabetes control.
The ACCU‑CHEK Aviva Plus blood glucose monitoring system should not be used for the diagnosis of or
screening of diabetes or for neonatal use. Alternate site testing should be done only during steady‑state times
(when glucose is not changing rapidly).
The ACCU‑CHEK Aviva Plus test strips are for use with the ACCU‑CHEK Aviva blood glucose meter to
quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips,
forearm, upper arm, or palm.
This system is intended to be used by a single person and should not be shared.
The ACCU‑CHEK Aviva Plus blood glucose monitoring system includes:
ACCU‑CHEK Aviva meter with battery, ACCU‑CHEK Aviva Plus test strips and code key*, ACCU‑CHEK Aviva
control solutions*, ACCU‑CHEK FastClix lancing device* (with a black cap for fingertip testing and an AST cap**
for alternate site testing), ACCU‑CHEK FastClix lancet drum*.
*may be sold separately
**available upon request from the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072.
This file may not print or view at 100%.
Die lines and color breaks do not print.
“Holding Area” text, box and rules do not print.
Roche USA –51515
V2/1 – 05958083003 – Black
Roche USA – 51515
V2/2 – 05958083003 – PMS 287 CVC 30%
Important Safety Information
NOTE
The term “blood glucose” is used when referring to “blood sugar.”
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2
Important Safety Information
WARNING
• DO NOT CHANGE YOUR THERAPY BASED ON A TEST RESULT THAT DOES NOT MATCH HOW YOU FEEL OR IF
YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.
• It is always a good idea to have a back‑up testing method available. Failure to test could cause a delay in
therapy decisions and lead to a serious medical condition. Examples of back‑up testing methods include
a back‑up meter or testing by a laboratory. Ask your healthcare professional or pharmacist about other
possible back‑up methods.
• If your blood glucose result does not match how you feel and you have followed the instructions in this
Owner’s Booklet, follow your healthcare professional’s instructions, or contact your healthcare professional.
Need Help?
Contact the ACCU‑CHEK Customer Care Service Center toll‑free at 1‑800‑858‑8072. We oer assistance
24hours a day, 365days a year in many languages. You can also visit accu‑chek.com for diabetes
management tools and product demonstrations.
Please complete the warranty card and mail it, so you receive the best customer service possible and product
update news.
About Testing Yourself or Others
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3
Important Safety Information
WARNING
• During normal testing, any blood glucose meter or lancing device may come in contact with blood. All parts
of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne
pathogens, even after you have performed cleaning and disinfecting.
1,2
• The meter and lancing device should never be used by more than one person. Do not share the meter
and lancing device with anyone, including family members, due to the risk of infection from bloodborne
pathogens.
1,2
• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, bloodborne
pathogens.
3
• If the meter is being operated by a second person who is providing testing assistance to the user, the meter
and lancing device should be cleaned and disinfected prior to use by the second person.
• Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allow anyone
else to test with the meter or lancing device.
• It is important to keep the meter and lancing device clean and disinfected. For instructions on how to
clean and disinfect the meter and lancing device, see Chapter6, Meter and Lancing Device Cleaning and
Disinfecting.
• Wash hands thoroughly before and after handling the meter, lancing device, or test strips.
NOTE
• Perform a control test when you open a new test strip box or if you think that a test result is incorrect.
Performing a control test lets you know that the meter and test strips are working properly.
• Refer to the test strip and control solution package inserts for additional health‑related information.
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4
Important Safety Information
WARNING
• Carefully read and follow the instructions in the Owner’s Booklet and package inserts for the test strips and
control solution. It is very important to follow the instructions in order to avoid an incorrect test result that
leads to improper therapy.
• Inspect the test strip container before using the test strips for the first time. If you see any damage to the
container cap or if anything prevents the cap from closing properly, do not use the test strips. Contact the
ACCU‑CHEK Customer Care Service Center. Damaged test strips can cause inaccurate results, which could
lead to improper therapy.
• The meter, test strips, and control solution are only for use outside the body (in vitro). Do not eat the test
strips. Do not swallow or inject the control solution or use the control solution for any purpose other than
testing the ACCU‑CHEK Aviva Plus system.
Special Information for Caregivers
• Do not use the meter system to measure blood glucose in people who are experiencing cardiovascular
collapse (severe shock) or decreased peripheral blood flow.
• Consult your healthcare professional to determine if it is appropriate for your child to be taught how to use the
meter system or any other medical products.
• Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia). Others, such
as children or people who are unconscious or have certain disabilities, may not be able to communicate their
symptoms to caregivers. For these reasons, do not change any therapy without first talking to a healthcare
professional.
Before You Start Testing
NOTE
• Set the time and date on the meter before you begin testing.
• Your system has been calibrated to deliver plasma‑like values for easier comparison to lab results.
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5
Your New System
1. Display
Shows results, messages, and test results
stored in memory.
2. Right Arrow and Left Arrow Buttons
Press to enter memory, adjust settings, and
scroll through test results.
3. Test Strip Slot
Insert test strip here.
2
4
58
4. Code Key Slot
Insert code key into this opening.
5. Battery Door
Flip open to replace battery.
6. Power/Set Button
Turns meter on or o and sets options.
7. Infrared (IR) Window
Transfers data from meter to computer.
8. Battery
Insert into battery compartment with (+)side
facing up.
3
Chapter 1: Your New System
The ACCU-CHEK Aviva Meter
6
7
1
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6
Your New System
9. Test Strip Container
10. Golden End
Insert this end into meter.
11. Yellow Window
Touch blood drop or control solution here.
12. Control Solution Bottle
13. Code Key (for example)
(for example)
10
11
9
12
13
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7
Your New System
1. Cap
For fingertip testing.
2. Comfort Dial with Depth
Selection
Select penetration depth.
3. Penetration Depth Indicator
Points to depth setting.
4. Lever
Advance to a new lancet.
5. Lancet Counter Window
Shows number of available
lancets.
6. Release button
Press to prime and prick.
7. Lancet Drum
Contains 6lancets.
8. AST Cap
For Alternate Site Testing
(available upon request from
the ACCU‑CHEK Customer
Care Service Center at
1‑800‑858‑8072).
The ACCU-CHEK FastClix Lancing Device
NOTE
Some items may be sold separately.
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8
Your New System
Button Functions
Here are the functions of the power/set and arrow buttons on the meter. These functions are used throughout
this booklet.
Button Function Action
Turn the meter on or o. Press and release .
Enter the set‑up mode. Turn the meter on. Press and hold until set-up appears
on the display.
Exit the set‑up mode at any
time.
Press and hold until the flashing test strip symbol
appears on the display.
Set the chosen feature. Press and release .
Check the display segments. Check the display before each test to make sure all
segments are clear and look like the picture to the left.
Turn the meter o. Press and hold to see the complete
display.
If one of the segments is missing or looks dierent from the
picture, do not use the meter. Contact the ACCU‑CHEK
Customer Care Service Center at 1‑800‑858‑8072.
Adjust settings for time and
date, beeper, test reminders,
and hypoglycemic alert.
Press and release or .
Press and hold or to scroll faster.
Enter memory. Press and release or .
Mark a blood glucose result. Press and release or .
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9
Your New System
Coding the Meter
1
Turn the code key over so
the code number faces
down.
Push the code key into the
code key slot until it stops.
Leave the code key in the
meter until a new test strip
box is opened.
Make sure the meter
is o.
Turn the meter over,
remove the old code key
(if there is one in the
meter) and discard it.
2
WARNING
Change the code key every time a new test strip box is opened! For accurate results, it is important to be
sure the code key matches the code number on the test strip container.
NOTE
• If you see code and a flashing - - - on the display, insert a code key into the meter.
• Do not force the code key into the meter. There is only one correct way to insert the code key.
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10
Your New System
1
Adjusting the Time and Date (First Time Use)
The meter is preset with the time and date which may need to be adjusted to the local time zone. It is
important to set the correct time and date in the meter to use the meter memory or to transfer results to a
computer.
Press and hold until the
flashing test strip symbol
appears on the display.
The time and date are
now set.
4
Press and release or
to decrease or increase
the hour.
Press and release to set
the hour.
The minutes flash.
Turn the meter on.
The time and date appear
on the display. Set-up and
the hour flash. If the time
and date are correct, press
and hold to exit.
2
Repeat step2 to set
minutes, am/pm, month,
day, and year.
The flashing field is the
one that is being changed.
3
NOTE
• After you change the battery, the meter automatically prompts a time and date confirmation when it is
turned on.
• To set more options on the meter, see Chapter 5, Meter Memory, Setup, and Data Transfer.
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11
Your New System
Using the ACCU-CHEK Aviva Plus System
• Replace the code key and perform a control test every time you open a new test strip box.
• Use the test strip immediately after removing it from the test strip container.
• Do not apply blood or control solution to the test strip before inserting it into the meter. Retest with a new test
strip. If a result appears before applying blood or control solution, do not act on that result.
• Close the test strip container tightly immediately after removing a test strip. Moisture can damage the test
strips and produce incorrect results.
• Store the unused test strips in their original container with the cap tightly closed.
• Discard the test strips if they are past the Use By date printed on the test strip container. If the Use By date is
missing or cannot be read, do not use the test strips. Contact the ACCU‑CHEK Customer Care Service Center at
1‑800‑858‑8072.
• Refer to the test strip package insert for test strip storage and system operating conditions.
• Do not remove test strips from the test strip container and put them into another container, such as a plastic
bag, pocket, purse, wallet, etc.
• Do not reuse test strips. Once control solution or blood has been applied to a test strip, discard it. If a retest is
necessary, use a new test strip.
WARNING
To prevent inaccurate results:
• DO NOT expose test strips to heat, moisture, or humidity. Temperatures outside the required range, as well
as moisture and humidity, can damage the test strips and lead to inaccurate results.
• DO NOT bend, cut, or alter the test strips.
• DO NOT get dirt, food, or other material on the test strip.
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12
Control Tests
When to Perform a Control Test
Performing a control test lets you know the meter and test strips are working properly. You should perform a
control test when:
• you open a new test strip box.
• you left the test strip container open.
• you think the test strips are damaged.
• you want to check the meter and test strips.
• the test strips were stored in extreme temperatures, humidity, or both.
• you dropped the meter.
• your test result does not match how you feel.
• you want to check if you are performing the test correctly.
About the Control Solution
• Use only ACCU‑CHEK Aviva control solution.
• Close the control solution bottle tightly after use.
• Write the date you open the control solution bottle on the bottle label. The control solution must be discarded
3months from the date the control solution bottle was opened (discard date) or on the Use By date on the
bottle label, whichever comes first.
• Do not use control solution that is past the Use By or discard date.
• Refer to the control solution package insert for control solution storage conditions.
• The meter automatically recognizes the dierence between the control solution and blood.
• The control results are not displayed in memory.
• The control solution can stain fabric. Remove stains by washing with soap and water.
• Control solution is available for purchase. To order the control solution, talk to your pharmacist or visit
accu‑chek.com to order online.
Chapter 2: Control Tests
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13
Control Tests
Make sure the code
number on the display
matches the code number
on the test strip container.
If you miss seeing the
code number, remove the
test strip and reinsert it
into the meter.
5
Remove the bottle cap.
Wipe the tip of the bottle
with a tissue.
Squeeze the bottle until a
tiny drop forms at the tip.
Touch the drop to the
front edge of the yellow
window of the test strip
until you see flash.
Do not put control
solution on top of the
test strip.
6
Insert the test strip into
the meter in the direction
of the arrows.
Place the meter on a flat
surface.
3
Select the control solution
to test. You will enter the
level later in the test.
Check the meter display
for missing segments.
All segments should look
like the picture.
1 2
Performing a Control Test
You need the meter, a test strip, and control solution Level 1 or Level 2. The control level is printed on the bottle label.
The control result, the
bottle symbol, and a
flashing L appear on the
display.
Do not remove the test
strip yet.
or
4
When you see flash,
there is enough control
solution in the test strip.
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14
Control Tests
Press once to mark the
control result as a Level 1.
Press a second time to
mark the control result as
a Level 2. Press to set
the control level in the
meter.
8
Wipe the tip of the bottle
with a tissue. Cap the
bottle tightly.
NOTE
• Most people just test the Level 1 control. If you wish, you can also test a Level 2 control. A set of Level 1 and
Level 2 control solutions is available for purchase. To order control solutions, talk to your pharmacist or visit
www.accu‑chek.com to order online.
• The ranges for Level 1 and Level 2 control solutions are printed on the test strip container label.
• After a successful test, the meter turns o 5 seconds after the test strip is removed.
7
OK and the control result
alternate on the display if
the control result is in
range OR Err and the
control result alternate on
the display if the control
result is not in range.
Remove and discard the
used test strip.
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15
Control Tests
WARNING
The control range applies only to a control result. It only indicates that the test strips and meter are working
properly. Do not use a control result to interpret blood glucose results.
If the control result is out of range, do not use the meter until you solve the problem. Check this list to help
solve the problem.
Understanding Out-of-Range Control Results
Troubleshooting Checks Action
1. Were the test strips or control solutions
expired?
Discard the test strips or control solution if either is past
the Use By date. If the control solution was opened more
than 3months ago, discard it. Repeat the control test
with an unexpired test strip and an unexpired control
solution.
2. Did you wipe the tip of the control solution
bottle before use?
Wipe the tip of the bottle with a tissue. Repeat the
control test with a new test strip and a fresh drop of
control solution.
3. Were the caps on the test strip container
and the control solution bottle always
closed tightly?
Replace the test strips or control solution if you think
either was uncapped for some time. Repeat the control
test.
4. Was the test strip used immediately after it
was removed from the test strip container?
Repeat the control test with a new test strip and a fresh
drop of control solution.
5. Were the test strips and control solutions
stored in a cool, dry place?
Repeat the control test with a properly stored test strip
or control solution.
6. Did you follow the directions? Read Chapter2, Control Tests, and repeat the control
test.
7. Did you choose the correct control solution
level, either 1 or 2, when you performed
the test?
If you chose the wrong control solution level, you can
still compare the control result to the range printed on
the test strip container.
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16
Control Tests
Troubleshooting Checks Action
8. Does the code number on the meter
display match the code number on the test
strip container?
If they do not match, insert the correct code key in the
meter and test again.
9. Are you still unsure of the problem? Contact the ACCU‑CHEK Customer Care Service Center
at 1‑800‑858‑8072.
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3
17
The ACCU-CHEK FastClix Lancing Device
Using the ACCU-CHEK FastClix Lancing Device
• The black cap is for fingertip testing only.
• Remember that the opening where the lancet comes out is not in the center of the
cap.
• Remove the cap by pulling it straight o. Do not twist the cap.
• The AST cap* is for testing other approved sites on the body, not the fingertip.
• Remove the cap by pulling it straight o. Do not twist the cap.
• We suggest starting at a depth setting of 5½ for forearm or upper arm testing, and a
depth setting of3 for palm testing. Once you perform a successful blood glucose test,
you may want to find the lowest depth setting that provides enough blood with the
least amount of pain.
• A new lancet drum is dark gray with a white end.
• A used lancet drum has a visible red stripe on the white end.
• You cannot reuse a used lancet drum.
• Do not remove the lancet drum until you have used all 6 lancets.
• The penetration depth indicator on the comfort dial shows the current depth setting.
The higher the number, the deeper the penetration. The best depth setting is the
lowest number that lets you get enough blood for a test. Try dierent depth settings to
find the one that is right for you.
• For soft skin, we suggest a depth setting of2. For thick skin, try a higher depth
setting.
*Available upon request from the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072.
Chapter 3: The ACCU-CHEK FastClix Lancing Device
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3
18
The ACCU-CHEK FastClix Lancing Device
WARNING
You must not insert the lancet drum into the lancing device and simultaneously press the release button or
hold the lancing device with the release button resting on a surface such as a table top. This could release a
lancet and inadvertently cause injury.
Inserting a Lancet Drum
You must first load the lancet drum into the lancing device to get it ready for use.
1
Remove the cap.
Insert a new lancet drum,
white end first, until it
clicks firmly into place.
2
Slide the cap on until it
stops by aligning the
notch on the cap with the
notch on the lancing
device.
3
You are now ready to use
the first lancet.
The lancet counter shows
a number6, meaning you
have 6new lancets
remaining.
NOTE
Once the lancet drum is inserted into the lancing device, do not remove the lancet drum until completely
used. The lancet drum cannot be reused once it has been removed from the lancing device.
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