Accu-Chek Compact Plus User manual

Owner’s Booklet for Self-Testing Only
Blood Glucose Meter
Manual del usuario únicamente
para autocontrol
Medidor de Glucemia
This le may not print
or view at 100%.
Die lines and color
breaks do not print.
Roche USA – xxxxx
V4/1 – 07699336001 – Black
Roche USA – xxxxx
V4/2 – 07699336001 – Cyan
Roche USA – xxxxx
V4/3 – 07699336001 – Magenta
Roche USA – xxxxx
V4/4 – 07699336001 – Yellow
ONR 00008754 – 4 ALL 4774 (2015) DE 07699336001_01
US 07699336001_0515
Format 105x148A-US
Compact-Plus-MIC-US_man_Version06_Master_Rev1, 13-May-2015
Reason for revision: Namen Change Project (master change DCNC-L), revisions as comments
man_07699336001_01_EN.indb 1 08.10.2015 10:07:14

man_07699336001_01_EN.indb 2 28.09.2015 13:26:05

3
Contents
Introduction ...............................................................................................................................................7
The ACCU-CHEK Compact Plus System ...........................................................................................................8
Need Help?......................................................................................................................................................9
Important Safety Information .........................................................................................................................10
About Testing Yourself or Others ....................................................................................................................11
Before You Start Testing.................................................................................................................................12
Chapter 1: Understanding Your New System.........................................................................................13
The ACCU-CHEK Compact Plus System .........................................................................................................13
Using the ACCU-CHEK Compact Plus System ................................................................................................15
Meter Setup...................................................................................................................................................17
Setting the Beeper On/OFF ............................................................................................................................18
Setting the Brightness of the Display.............................................................................................................20
Setting the Year, Time, and Date ....................................................................................................................21
Setting the Test Reminders............................................................................................................................23
Setting the Hypoglycemic (Hypo) Indicator.....................................................................................................26
Installing the Test Drum.................................................................................................................................28
Test Strip Count .............................................................................................................................................32
Chapter 2: Control Testing ......................................................................................................................33
Why Perform Control Tests.............................................................................................................................33
About the Control Solutions ...........................................................................................................................34
Performing a Control Test...............................................................................................................................35
Understanding Out-of-Range Control Results.................................................................................................41
man_07699336001_01_EN.indb 3 28.09.2015 13:26:05

4Chapter 3: Testing Your Blood Glucose..................................................................................................43
Using the ACCU-CHEK Softclix Plus Lancing Device.......................................................................................43
Inserting a Lancet..........................................................................................................................................45
Preparing the Lancing Device for Fingertip Testing ........................................................................................47
Detaching and Attaching the Lancing Device.................................................................................................48
Performing a Blood Glucose Test with Blood from Your Fingertip ...................................................................49
Performing a Blood Glucose Test with Blood from Your Palm (Alternate Site Testing, or AST).........................56
Flagging Test Results.....................................................................................................................................67
Unusual Test Results......................................................................................................................................68
Symptoms of High or Low Blood Glucose......................................................................................................71
Comparing Your Meter Result to a Laboratory Result.....................................................................................72
Chapter 4: Meter Memory and Transferring Results.............................................................................73
Memory .........................................................................................................................................................73
Viewing Test Results ......................................................................................................................................75
Viewing Averages, Highest and Lowest Results .............................................................................................76
Transferring Your Results to a Computer........................................................................................................78
Chapter 5: Cleaning and Disinfecting the Meter and Lancing Device .................................................81
Cleaning and Disinfecting the Meter..............................................................................................................83
Cleaning and Disinfecting the Lancing Device ...............................................................................................88
Chapter 6: Maintenance and Troubleshooting ......................................................................................93
Display check ................................................................................................................................................93
Changing the Batteries ..................................................................................................................................94
Display and Error Messages ..........................................................................................................................96
man_07699336001_01_EN.indb 4 28.09.2015 13:26:05

5
Chapter 7: Technical Information.........................................................................................................109
Product Limitations......................................................................................................................................109
Specications ..............................................................................................................................................109
Product Safety Information ..........................................................................................................................111
Travel Documentation..................................................................................................................................111
Explanation of Symbols................................................................................................................................113
Warranty......................................................................................................................................................114
Limited License ...........................................................................................................................................116
Additional Supplies ......................................................................................................................................118
Index.......................................................................................................................................................119
man_07699336001_01_EN.indb 5 28.09.2015 13:26:05

6
man_07699336001_01_EN.indb 6 28.09.2015 13:26:05

7
Dear ACCU‑CHEK System Owner,
Thank you for choosing the ACCU-CHEK Compact Plus system!
Congratulations on your decision to take control of your diabetes. We have designed your new ACCU-CHEK
Compact Plus system with comfort, convenience, and control in mind to help make living with diabetes a
little easier.
This booklet will help you get the most from your ACCU-CHEK Compact Plus system.
To start testing quickly, refer to the First Time Guide.
For questions, visit our web site at www.accu-chek.com/support or call the ACCU-CHEK Customer Care
Service Center at 1-800-858-8072. We offer assistance in many languages. You can also visit
www.accu-chek.com for diabetes management tools and product demonstrations.
Thanks again for choosing the ACCU-CHEK Compact Plus system.
WARNING
Before using the system, please read the Important Safety Information section on the following
pages.
man_07699336001_01_EN.indb 7 28.09.2015 13:26:05

8The ACCU‑CHEK Compact Plus System
The ACCU-CHEK Compact 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 ngertips or palm.
The ACCU-CHEK Compact Plus Blood Glucose Monitoring System is intended to be used by a single person
and should not be shared.
The ACCU-CHEK Compact 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 effectiveness of diabetes
control. The ACCU-CHEK Compact 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 Compact Plus test strips are for use with the ACCU-CHEK Compact Plus Blood Glucose
Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the
ngertips or palm.
This system is intended to be used by a single person and should not be shared.
NOTE
In this Owner’s Booklet the term “blood glucose” is used when referring to “blood sugar.”
man_07699336001_01_EN.indb 8 28.09.2015 13:26:05

9
Need Help?
For questions, visit our web site at www.accu-chek.com/support or call the ACCU-CHEK Customer Care
Service Center at 1-800-858-8072. We offer assistance in many languages. You can also visit
www.accu-chek.com for diabetes management tools and product demonstrations.
Please complete your warranty card and mail it, so you receive the best customer service possible and
product update news.
The system includes:
•ACCU‑CHEK Compact Plus meter with batteries and attached
ACCU‑CHEK Softclix Plus lancing device+
(with a black cap for fingertip testing and an AST cap* for alternate site testing)
•ACCU‑CHEK Compact Plus test drum (17 tests)*
•ACCU‑CHEK Compact Plus clear control solution*
•ACCU‑CHEK Softclix lancets*
+
Lancing device replacements are available by calling the ACCU-CHEK Customer Care Service Center at
1-800-858-8072 or visiting www.accu-chek.com.
*sold separately
man_07699336001_01_EN.indb 9 28.09.2015 13:26:05

10 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 disinfection.1,2
• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all,
bloodborne pathogens.3
• 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
• 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 5 “Cleaning and
Disinfecting the Meter and Lancing Device.”
• Wash hands thoroughly before and after handling the meter, lancing device, or test strips.
man_07699336001_01_EN.indb 10 28.09.2015 13:26:05

11
About Testing Yourself or Others
WARNING
• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you
think you are dehydrated, contact your healthcare professional right away.
• DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW
YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.
• 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
treatmentwithoutrsttalkingtoahealthcareprofessional.
• It is always a good idea to have a back‑up testing method available. Failure to test could cause
a delay in treatment 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.
• If peripheral circulation is impaired, collection of capillary whole blood from the approved
samplesitesisnotadvisedastheresultsmightnotbeatruereectionofthephysiological
blood glucose level. This may apply in the following circumstances: Severe dehydration as a
result of diabetic ketoacidosis or due to hyperglycemic hyperosmolar non‑ketotic syndrome,
hypotension, shock, decompensated heart failure NYHA Class IV, or peripheral arterial occlusive
disease.
• Not to be used for patients who are critically ill.
man_07699336001_01_EN.indb 11 28.09.2015 13:26:05

12
Before You Start Testing
About the Meter and Test Strips
WARNING
• Carefully read and follow the instructions in the Owner’s Booklet and Package Inserts for the
test strips and control solutions. It is very important to follow the instructions in order to prevent
a wrong result or improper treatment.
• Inspect the test drum container before using the test drum. If you see any damage to the
container cap or if anything prevents the cap from closing properly, do not use the test drum.
Contact the ACCU‑CHEK Customer Care Service Center. Damaged test strips can cause
inaccurate results, which could lead to improper treatment.
• The meter, test strips, and control solutions are only for use outside the body (in vitro). Do not
eat the test strips. Do not swallow or inject control solutions or use control solutions for any
purpose other than testing the ACCU‑CHEK Compact Plus system.
NOTE
• Set the time and date on your meter before you begin testing.
• Although you always apply fresh capillary whole blood to the test strip, your system has been calibrated
to deliver plasma-like values for easier comparison to lab results.
NOTE
• Perform a control test when you open a new box of test drums or if you think that your test result is
incorrect. Performing a control test lets you know that the meter and test strips are working properly.
• Refer to your Test Strip and Clear Control Solution Package Inserts for additional health-related information.
man_07699336001_01_EN.indb 12 28.09.2015 13:26:05

13
Chapter 1: Understanding Your New System
The ACCU‑CHEK Compact Plus System
Infrared (IR)
Window –
Transfers data from
the meter to a
computer or PDA.
Display –
Shows results,
messages, and
results stored in
memory.
M Button –
Press to enter
memory, and scroll
through results in
memory.
Drum Door –
Covers the
compartment where
the test drum goes.
Test Strip Slot –
Test strips come out
of the meter here.
Test/On/Off Button –
Slide and release this
button to turn on the
meter and advance a
test strip. Also, at the
completion of a test,
slide and release this
button to turn off the
meter and release
the test strip.
S Button –
Press to set the
beeper, year, time,
and date.
Drum Door Tab –
Lift up on this tab to
open the drum door.
Release Button –
Slide to release the
attached lancing
device. You can use
your lancing device
attached or
unattached.
Battery Door –
Slide the door to
unlock and open the
battery compartment.
Test Strip Count
Window – Shows
the number of test
strips remaining in a
test drum.
Front View Back View
man_07699336001_01_EN.indb 13 28.09.2015 13:26:06

14
NOTE
Some items may be sold separately.
Test Drum –
The bar code on
the label is
automatically
read by the
meter.
Test Strip –
Apply a drop
of blood or
control solution
to the black
notch on the
end of the test
strip.
Protective
Cover
Lancet
Top View
Infrared (IR) Window
Cap –
Comfort Dial with
Depth Selection
Depth Indicator Plunger
Lancing Device
AST Cap –
(for obtaining blood
from alternate sites)
man_07699336001_01_EN.indb 14 28.09.2015 13:26:08

15
Using the ACCU‑CHEK Compact Plus System
• Only use ACCU-CHEK Compact Plus test strips. Using other test strips with this meter will produce
inaccurate results.
• Perform a control test every time you open a new box of test strips.
• Refer to the test strip package insert for test strip storage and system operating conditions.
• Store the test drum in its original container with the cap closed. Moisture can damage the test strips and
produce incorrect results.
• Do not remove test drums from the drum container and put them into another container, such as a plastic
bag, pocket, purse, wallet, etc.
• Use only test drums on which the aluminum foil is intact on both sides.
• Discard the test drum if it is past the “Use by” date printed on the test drum container. If the “Use by” date
is missing or cannot be read, do not use the test drum. Visit our web site at www.accu-chek.com/support
or call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072.
• Never push any test strip back into the meter or the test drum. These test strips can produce incorrect
results.
• If you do not turn off the meter after a test, the meter turns off automatically after about 60 seconds. The
result is saved in the memory. The test strip then remains in the meter. When you slide and release to
turn on the meter, it simply releases the test strip and turns itself off again.
man_07699336001_01_EN.indb 15 28.09.2015 13:26:08

16
WARNING
• DO NOT expose test drums to heat, moisture or humidity. Temperatures outside the required
range, as well as moisture and humidity, can damage your 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.
Not following these precautions can lead to inaccurate results.
man_07699336001_01_EN.indb 16 28.09.2015 13:26:08

17
Meter Setup
Your meter comes with the batteries already installed. The meter is preset with the time and date which may
need to be adjusted to the local time zone. Setting the correct time and date in the meter is important to
review the results in memory or to transfer the results to a computer.
Using the Setup Mode
The following features can be customized as required:
•Beeper – Select “On” or “OFF.”
•Brightness – Set the brightness of the display.
•Time and date – Set the time and date.
•Test reminders – Select “On” or “OFF.” If you choose “On,” select 1 to 3 reminders per day
•Hypoglycemic (Hypo) indicator – Select “On” or “OFF.” If you choose “On,” select the blood glucose
level for the indicator.
Throughout this section, the blue progress bar helps guide you through the setup process.
The following rules apply when changing settings:
• You can change any setting at any time.
• With the meter off, press and release S
S to enter the set mode. “set” is shown on the display.
• Press and release S
S repeatedly until you reach the setting you want to change. The ashing eld is the
one that is being changed.
• Press and release M
M to change a selection or to increase numbers. Press and hold M M to scroll faster.
• To exit the set mode at any time and save your settings, slide and release .
man_07699336001_01_EN.indb 17 28.09.2015 13:26:09

18
BEEPER
(on/off) BRIGHTNESS (level) TIME / DATE (year, am/pm,
hrs, min, month, day)
TEST REMINDERS
(1, 2, 3) HYPO INDICATOR (off/on, level)
You are here
Setting the Beeper On/OFF
The meter beeper is preset to “On1.” This means the beeper is on. Setting the beeper to “OFF” does not
affect test results.
The beeper is helpful because it prompts you:
• To apply blood or control solution to the test strip
• When enough blood or control solution is drawn into the test strip
• When the test is complete
• When the hypo indicator is turned on and the result is below the level you have set
• If an error occurred
man_07699336001_01_EN.indb 18 28.09.2015 13:26:09

19
1. With the meter off, press and
release S
S to enter the set
mode. The meter turns on and
briey shows the display
symbols.
2. “On1” ashes and the beeper
symbol is displayed. This
means the beeper is on. Press
and release M
Mto switch
between “On1” and “OFF.”
3. Press and release S
Sto set
your selection. The brightness
setting comes next.
man_07699336001_01_EN.indb 19 28.09.2015 13:26:10

20
BEEPER
(on/off) BRIGHTNESS (level) TIME / DATE (year, am/pm,
hrs, min, month, day)
TEST REMINDERS
(1, 2, 3) HYPO INDICATOR (off/on, level)
You are here
Setting the Brightness of the Display
You can use this setting to adjust how bright you wish the displayed symbols and numbers to be. There are
three brightness levels: low, medium, and high. The brightness is factory-set to medium (shown by the
number “2” at the top right of the display).
Low brightness (level 1)
Medium brightness (level 2)
High brightness (level 3)
1. Press and release M
Mto move
to the next brightness level.
The brightness of the display
changes.
2. Press and release S
Sto set
your selection. The year setting
comes next.
man_07699336001_01_EN.indb 20 28.09.2015 13:26:10