Accu-Chek Combo system User manual

Accu-Chek Combo system User manual
Aviva Combo
00048010156/D-0615
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© 2015 Roche Diabetes Care
Assembled in USA.
Distributed by:
Roche Diabetes Care, Inc.
Indianapolis, IN 46256
Phone: 1-800-280-7801
Fax: 1-888-810-0758
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ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK
AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and
FASTCLIX are trademarks of Roche.
Aviva
AvivaCombo
Combo
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V6/2 – 00048010156/D – Cyan
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V6/3 – 00048010156/D – Magenta
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V6/4 – 00048010156/D – Yellow
BLOOD GLUCOSE METER
Roche USA – 53778
V6/5 – 00048010156/D – PMS 287
Advanced Owner’s Booklet
for Self-Testing Only
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V6/6 – 00048010156/D – PMS 5445
The Bluetooth® word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any
use of such marks by Roche is under license.
All other product names and trademarks are the
property of their respective owners.
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LAST UPDATE: 2015-06
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Before You Start Testing
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V4/1 – 00048010156/D – Black –
Roche USA – 53778
V4/2 – 00048010156/D – Cyan –
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V4/3 – 00048010156/D – Magenta –
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V4/4 – 00048010156/D – Yellow –
About the meter and test strips
• Carefully read and follow the instructions in the Getting Started Guide, the Standard Owner’s Booklet, the
Advanced Owner’s Booklet, and Package Inserts for the test strips and control solutions. Not following the
instructions may lead to a wrong result or improper treatment, causing you health problems.
• Set the time and date on your meter before you begin testing.
• 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
ACCU-CHEK Customer Care Service Center at 1-800-688-4578. Damaged test strips can cause inaccurate
results, which could lead to improper treatment.
• Carefully dispose of used test strips and lancets.
• Home use of the ACCU-CHEK Aviva Combo system is limited to capillary whole blood testing.
NOTE
The terms “blood sugar” and “blood glucose” have the same meaning. In this manual we will use the
term “blood glucose” when referring to “blood sugar.”
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About Your New Meter
• The meter is designed and can be used for testing fresh capillary whole blood samples (for example, blood
from a fingertip).
• Only use ACCU-CHEK Aviva Plus test strips. Other test strips will give inaccurate results.
• Although you always apply whole blood to the test strip, the system has been calibrated to deliver
plasma-like values for easier comparison to lab results.
• 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 Combo system.
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About Testing Yourself or Others
• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you think you are
dehydrated, call your healthcare professional right away.
• 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 first talking to a
healthcare professional.
• Run a control test when you open a new box of test strips or if you think that your test result is incorrect.
Running a control test lets you know that the meter and test strips are working properly.
• If peripheral circulation is impaired, collection of fresh capillary whole blood from the approved sample sites
is not advised as the results might not be a true reflection 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.
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• Refer to the Test Strip and Control Solution Package Inserts for additional health-related information.
• 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 lab. Ask your healthcare professional or pharmacist about other possible
back-up methods.
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.
If your blood glucose result doesn’t match how you feel and you have followed the instructions in your
owner’s booklets, follow your healthcare professional’s instructions or call your healthcare professional.
Special Information to Consider When Using This Meter
• Do not use this device to measure blood glucose if you or a person to whom you are providing care is
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.
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Contents
Before You Start Testing
i
Introduction
5
1 Bolus Advice
1.1 Overview
1.2 Before Using Bolus Advice
1.3 Calculating and Delivering a Bolus Using Bolus Advice
2 Administering a Bolus
2.1 Overview
2.2 Choosing Your Bolus Type
2.3 Delivering a Bolus
2.4 Updating the Diary with Bolus Information
7
8
10
13
25
26
27
29
31
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3 Using the ACCU-CHEK Aviva Combo Meter with the
ACCU-CHEK Spirit Combo Pump
3.1 Overview
3.2 The System at a Glance
3.3 Controlling the Pump with the Meter
3.4 Managing Pump Errors, Warnings, and Reminders with the Meter
4 Communication between the ACCU-CHEK Aviva Combo Meter and
ACCU-CHEK Spirit Combo Pump
4.1 Overview
4.2 Turning Bluetooth® Wireless Technology On/Off
4.3 Using the System While Traveling
4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump
4.5 Cancelling the Pairing of the Meter and Pump Prompt
5 Troubleshooting
5.1 Overview
5.2 Troubleshooting Communication Between the Meter and Pump
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34
35
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53
55
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57
60
61
67
69
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Appendices
Appendix A: Bolus Advice
Appendix B: Bolus Advice Calculations
Appendix C: Explanation of Symbols
Appendix D: Limited License
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79
98
102
103
Index
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Introduction
Whether the ACCU-CHEK Aviva Combo meter is your first blood glucose meter or you have used a meter for
some time, please take the time to read the Getting Started Guide, the Standard Owner’s Booklet, and the
Advanced Owner’s Booklet carefully before you use your new meter. To use it correctly and dependably, you
need to understand its operation, screen displays, and all individual features.
Your new meter includes three booklets:
This booklet includes information about:
• Getting Started Guide:
Use this booklet to set up the meter.
• Taking bolus advice
• Administering a bolus
• Standard Owner’s Booklet:
• Using the ACCU-CHEK Aviva Combo meter with the
Use this booklet for instructions on how to operate
ACCU-CHEK Spirit Combo pump
the standard features of the meter.
• Communication between the ACCU-CHEK
• Advanced Owner’s Booklet:
Aviva Combo meter and the ACCU-CHEK
Use this booklet for instructions on how to operate
Spirit Combo pump
the advanced features of the meter.
• Bolus advice calculations
Should you have any questions, please contact ACCU-CHEK Customer Care Service Center at
1-800-688-4578.
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WARNING
Choking hazard. Small parts. Keep away from children under the age of 3 years.
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1
1
Bolus Advice
1.1 Overview
1.2 Before Using Bolus Advice
1.3 Calculating and Delivering a Bolus Using Bolus Advice
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10
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1.1 Overview
Important information regarding the use of bolus advice is presented in this chapter. Read it carefully and
completely before you begin using bolus advice.
• It is recommended you discuss your bolus advice settings with your healthcare professional prior to setting
up this feature.
• Bolus advice is intended exclusively for use by well-trained individuals who perform their own insulin
therapy.
• Bolus advice is only available if you have set up bolus advice on your meter. For instructions on how to set
up bolus advice, see the Standard Owner’s Booklet.
• Bolus advice calculates insulin doses for you based on many different pieces of information, such as:
• The values you entered in the setup of bolus advice
• Your current blood glucose test result
• The amount of carbohydrates you estimated for a meal
• Your current health event status
• The blood glucose lowering due to prior correction doses
• The blood glucose influence of your most recent meal
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1
NOTE
• This booklet shows sample screens. The screens in this booklet may look slightly different from the
screens on your ACCU-CHEK Aviva Combo meter. If you have any questions about the meter screens,
contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
• Blood glucose and bG are interchangeable and mean the same thing.
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1.2 Before Using Bolus Advice
As with any specialized feature, you need to understand certain information in order to use bolus advice.
Working closely with your healthcare professional, you must be completely familiar with your diabetes
therapy. You must also be able to judge your current situation accurately. Bolus advice calculates boluses for
you. This can help you determine the amount of insulin you currently require. You provide the information on
which the bolus advice calculations are based.
Bolus advice is not able to judge your current situation independently of your own estimation. It cannot
correct possible input errors. This is particularly true for the carbohydrate amount entered. Entries that
exceed possible limits are recognized as such and in this case you are prompted to check the entry and
correct it, if necessary. However, as long as the entries fall within a possible range, the accuracy cannot be
checked by your meter. No warning message is displayed if the data are possible (within the acceptable
ranges) but incorrect. Therefore, it is important to carefully review all of your entries.
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1
Safety Information Regarding Bolus Advice
WARNING
• It is very important you follow the safety information in this chapter.
• Always compare your result with the way you actually feel and adjust the recommended bolus, if
necessary.
• Always carry out the actions entered into bolus advice in a timely fashion. Eat the carbohydrate
amount you entered and administer the insulin dose.
The following information is not taken into account when bolus advice is used:
• It is possible the values entered when setting up bolus advice do not match the way your body actually
feels. In this case, you can increase or decrease the bolus insulin dose to adjust it to your needs.
• Bolus insulin doses and meals taken before bolus advice is used for the first time cannot be reflected in the
calculation. The same applies for bolus insulin doses and meals that were taken but not entered into your
meter.
• If you delivered a bolus on your pump without using bolus advice, this information is entered in your diary.
It is important that you enter carbohydrate information into the diary with this bolus in order to obtain
accurate bolus advice recommendations. For information on how to enter information into the diary, see
the Standard Owner’s Booklet.
• The basal insulin doses you record do not influence the bolus advice.
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Warning messages about your blood glucose test result
After performing a blood glucose test, warning messages about your blood glucose test result may be
displayed. Please take careful note of these messages. If your blood glucose test result is too low, you
are prompted to eat a certain amount of fast acting carbohydrates to prevent the risk of hypoglycemia. A
bolus is not calculated in this situation. Treat your low blood glucose as recommended by your healthcare
professional.
Summary
• It is recommended that you set up bolus advice with your healthcare professional.
• Carefully check all of your entries.
• Make sure all recent meals and insulin doses are in My Data for accurate bolus advice recommendations.
• If you administer a bolus manually on your pump:
• Take note of all warning messages, especially those regarding high or low blood glucose test results.
Immediate action may be necessary.
• Always compare your result with the way you actually feel and adjust the bolus, if necessary.
• Always carry out the actions entered in bolus advice in a timely fashion.
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1
1.3 Calculating and Delivering a Bolus Using Bolus Advice
bG Test Result
Active Insulin
Recommended Bolus
Amount
Carb Entry
Health Event Entry
Bolus Type
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To Deliver a Bolus
Main Menu > Bolus Advice
1.
2.
Standard Owner’s Booklet for
information on how to perform
a blood glucose test. When
the detailed bG Result screen
appears, select Bolus.
j From the Main Menu, select
Bolus Advice and press =.
j If you have not completed
a recent blood glucose test
(this is indicated when “bG
Test” is displayed near the
top of the meter screen rather
than an actual bG value), it is
recommended you complete a
blood glucose test. Select bG
Test and press =. See the
To Enter a Carbs Amount:
j Select the Carbs entry field
and press =.
j Set the amount of
Carbohydrates and press =.
To Enter a Health Event:
j Select the Health entry field
and press =.
j Select a Health Event and
press =.
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3.
To Adjust the Bolus Amount:
j Select the Bolus entry field
and press =.
j Set the Bolus insulin amount
and press =.
To deliver a …
j Standard Bolus: Step 3
j Multiwave Bolus: Step 6
j Extended Bolus: Step 9
j Bolus manually on the
Pump: Step 12
j Bolus using an Insulin Pen
or Syringe: Step 14
1
4.
To Deliver a Standard Bolus
j Select the Type entry field and
press =.
j Select Standard and press =.
To confirm the entries, select
Confirm.
j To deliver the Standard bolus
remotely on your pump using
your meter, select Deliver and
proceed to the next step.
j To return to the Bolus Advice
screen, select Back.
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5.
You can choose one of the following:
j Select OK and display the Main
Menu. Bolus delivery continues
until it is complete.
j To stop bolus delivery, select
Stop Bolus. The Pump screen
BOLUS CANCELLED appears.
Note: Bolus delivery can be
stopped using your pump. For
instructions, see the pump User
Guide.
If no buttons are pressed, when
the bolus delivery is complete
the Delivery Completed screen
appears.
j Select Menu to go to the Main
Menu.
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6.
1
7.
To Deliver a Multiwave Bolus
j Select the Type entry field and
press =.
j Select Multiwave and press
=.
j To deliver the Multiwave bolus
remotely on your pump using
your meter, select Deliver.
j To return to the Bolus Advice
screen, select Back.
To confirm the entries, select
Confirm.
j To change the immediate
bolus, select Immediate entry
field and press =.
j Set the bolus amount and
press =.
j To change the duration, select
the Duration entry field and
press =.
j Set the length of duration and
press =.
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8.
You can choose one of the following:
j Select OK and display the Main
Menu. Bolus delivery continues
until it is complete.
j To stop bolus delivery, select
Stop Bolus. The Pump screen
BOLUS CANCELLED appears.
Note: Bolus delivery can be
stopped using your pump. For
instructions, see the pump User
Guide.
If no buttons are pressed, when
the bolus delivery is complete
the Immediate Delivery
Completed screen appears.
j Select Menu to go to the Main
Menu.
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9.
1
10.
11.
j To adjust the duration, select
the Duration entry field and
press =.
j Set the length of duration and
press =.
j To deliver the Extended bolus
remotely on your pump using
your meter, select Deliver.
j To return to the Bolus Advice
screen, select Back.
j Select Menu to go to the Main
Menu.
To Deliver an Extended Bolus
j Select the Type entry field and
press =.
j Select Extended and press =.
To confirm the entries, select
Confirm.
Note: Bolus delivery can be
stopped using your pump. For
instructions, see the pump User
Guide.
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12.
To Deliver a Bolus Manually
on the Pump
j Select the Type entry field and
press =.
j Select Manual Pump and press
=.
To confirm the entries, select
Confirm.
13.
WARNING
Start the delivery of the
exact bolus amount on the
pump within 10 minutes. See
WARNING at the end of this
section.
The bolus amount is displayed
on the meter screen.
j Manually program the pump
and deliver the bolus, or if
necessary, select Back and
return to the Bolus Advice
screen to adjust the bolus.
j Select OK to go to the Main
Menu.
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14.
To Deliver a Bolus Using an
Insulin Pen or Syringe
j Select the Type entry field and
press =.
j Select Pen/Syringe and press
=.
To confirm the entries, select
Confirm.
15.
1
The bolus amount is displayed
on the meter screen.
j Inject the bolus using an
insulin pen or syringe or, if
necessary, select Back and
return to the Bolus Advice
screen to adjust the bolus.
j Select OK to go to the Main
Menu.
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WARNING
• Bolus advice provided by the meter is solely advice. Contact your healthcare professional prior to
changing your diabetes therapy.
• It is important to make the correct selection for the carbohydrate ratio and insulin sensitivity. If you
select the wrong ratio (the basis for all calculations), all future bolus advice recommendations will be
wrong.
• If a pump bolus delivery is stopped, the bolus amount stored in the meter is updated when the next
pump synchronization occurs. Ensure the bolus information in the diary is correct prior to starting a
new bolus advice calculation. For information on how to view and edit diary data, see the Standard
Owner’s Booklet.
• Accuracy of bolus advice will be impacted if Bluetooth wireless technology is off or the batteries are
low. The bolus advice calculation will not include recent insulin boluses delivered by the pump.
• Reference Step 13: If the Manual Pump screen appears on the meter and you select OK, start delivery
of the exact bolus amount on the pump within 10 minutes. If not, you will get an extra record in My
Data and Bolus Advice. Extra records may influence future bolus advice.
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1
NOTE
• Bolus advice can also be accessed after you perform a bG Test (see the Standard Owner’s Booklet).
When the detailed bG Result screen is displayed, press .. This is not available if your bG result is
below your hypo warning limit (red color bar is displayed).
• For additional information about different bolus types, see Chapter 2, Administering a Bolus.
• You can only select one health event for each bolus recommendation.
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2
2
Administering a Bolus
2.1 Overview
2.2 Choosing Your Bolus Type
2.3 Delivering a Bolus
2.4 Updating the Diary with Bolus Information
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2.1 Overview
There are several methods to deliver a bolus.
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2
2.2 Choosing Your Bolus Type
There are several types of bolus delivery available. The bolus types include:
• Standard
A bolus that is immediately delivered to cover a food or a blood glucose correction. When Standard
is selected, the bolus is delivered by the pump. This option is available only when Bluetooth wireless
technology is turned on and the meter and pump are communicating.
• Multiwave
A bolus designed to better simulate the body’s insulin delivery. It combines an immediate bolus delivery
followed by an Extended Bolus delivery. A Multiwave Bolus might be helpful, for example, when you have
meals that include both rapidly and slowly absorbed carbohydrates. This option is available only when
Bluetooth wireless technology is turned on and the meter and pump are communicating.
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• Extended
A bolus delivered over a period of time. The Extended Bolus might be helpful, for example, during long
meals, dinners, or receptions, or when you have meals that are digested slowly or for people who have
gastroparesis (delayed digestion). This option is available only when Bluetooth wireless technology is
turned on and the meter and pump are communicating.
• Manual Pump
A Manual Pump bolus type is available when using bolus advice. It can be used at anytime, but is
intended for times when the meter and pump are not communicating. You must manually program the
pump to deliver the bolus. For instructions on how to program a bolus on the pump, see the pump User
Guide.
• Pen/Syringe
The Pen/Syringe bolus type is available when using bolus advice. It can be used at anytime, but is
intended for times when the meter and pump are not communicating and/or insulin delivery has been
interrupted on the pump. You must use an insulin pen or syringe to inject the bolus amount.
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2
2.3 Delivering a Bolus
WARNING
• Incorrect meter settings may cause inappropriate insulin delivery.
• The meter must be configured with your personal settings prior to administering a bolus. If you are not
sure about your personal settings, talk to your healthcare professional.
• Work with your healthcare professional to determine the timing, amount, and type of bolus you need to
deliver.
• If an intended bolus is unintentionally stopped, it is recommended you administer the remaining bolus
manually with the pump or remotely using the meter. You may also administer the bolus through bolus
advice by entering the remaining bolus amount and then administering it. Check the meter diary or the
pump diary to determine how much insulin has already been delivered. If the bolus was delivered and
stopped via the meter, when the next pump synchronization occurs the amount of insulin delivered is
updated in the meter diary.
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NOTE
You can cancel a bolus (including an extended bolus) that is being delivered by the pump directly on the
pump or remotely using the meter (through the Pump Menu on the meter).
Delivering a Bolus Using Bolus Advice
For instructions on how to deliver a bolus using bolus advice, see Chapter 1, Bolus Advice.
Delivering a Bolus Using an Insulin Pen or a Syringe
Follow the instructions of your healthcare professional when delivering a bolus using an insulin pen or a
syringe.
Delivering a Bolus Using the ACCU-CHEK Aviva Combo Meter and the ACCU-CHEK Spirit Combo Pump
You can use the meter to remotely deliver a bolus on the pump through bolus advice or through the Pump
Menu. For instructions on how to deliver a bolus using bolus advice, see Chapter 1, Bolus Advice. For
instructions on how to deliver a bolus remotely on the pump using the meter, see Chapter 3, Using the
ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump.
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2
2.4 Updating the Diary with Bolus Information
When the pump is synchronized with the meter, bolus information from the pump is imported into the meter.
For any manual pump bolus record in the meter database with a time stamp that is older than 10 minutes
and is not confirmed by the pump, the meter does away with the bolus record by changing the bolus amount
to “0.0” on the next meter and pump synchronization. This eliminates the possibility of having a bolus on
the meter that was not delivered on the pump.
If you used the bolus advice feature and delivered a bolus manually on the pump, it is important you update
the information in the diary to reflect the amount of carbohydrates eaten with the bolus to ensure accurate
bolus advice recommendations. If a bolus is delivered using an insulin pen or syringe (not through bolus
advice), it is important to enter this information in the meter diary to ensure accurate bolus advice
recommendations.
For instructions on how to add and edit data in your diary, see the Standard Owner’s Booklet.
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3
3
Using the ACCU-CHEK Aviva Combo Meter with
the ACCU-CHEK Spirit Combo Pump
3.1 Overview
3.2 The System at a Glance
3.3 Controlling the Pump with the Meter
3.4 Managing Pump Errors, Warnings, and Reminders with the Meter
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35
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3.1 Overview
The ACCU-CHEK Aviva Combo meter can be used to remotely control the ACCU-CHEK Spirit Combo insulin
pump using Bluetooth wireless technology. Before using the meter to control the pump, it is important to
understand how to operate the pump using the meter.
If you experience any communication problems between the pump and meter, it is recommended that
you go directly to the pump and operate the pump manually. For more information on troubleshooting
communication between the meter and pump, see Chapter 5, Troubleshooting.
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3
3.2 The System at a Glance
In the meter’s Pump Menu, the meter buttons have different functions. The buttons function as button (key)
presses on the pump.
The pump sends screens
to the meter.
d
f
The meter sends button
presses to the pump.
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Button Functions in the Pump Menu
Meter Button
Pump Key
Function
x
a
j Move forward in an information screen
j Increase a setting
j Program a Quick Bolus
j Cancel a Quick Bolus
j Turn off the STOP-Warning
z
s
j Move backward in an information screen
j Decrease a setting
j Program a Quick Bolus
j Cancel a Quick Bolus
j Turn off the STOP-Warning
<
>
d
f
j Cycles through menus, functions, and information screens
j Selects current settings displayed on screen
j Saves changes
j Exits a screen
j Allows you to view the QUICK INFO screen
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Meter Button
.
Pump Key
d
,
and
None
Function
a
3
j Exits menus, function screens, and information screens
without saving your changes
j Move to the previous screen
j Return to the Main Menu
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3.3 Controlling the Pump with the Meter
When Bluetooth wireless technology is turned on, the pump main screen appears on the meter when you are
in the Pump Menu.
The meter is able to control the following pump functions:
• Standard Bolus
• Extended Bolus
• Multiwave Bolus
• Temporary Basal Rate
• My Data
• Basal Rate Selection
• Basal Rate Programming (1-5 all individual)
• Reminder Settings
• Time and Date Settings
• Pump Settings
• Therapy Settings
• Menu Settings
• Stop Your Pump
If you attempt to access a pump function that is not available through the meter, the meter displays the ONLY
ACCESSIBLE ON PUMP screen.
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The following pump functions cannot be remotely controlled using the meter:
3
• Changing the insulin cartridge
• Priming the infusion set
• Rewinding the piston rod
• Data transfer (to a computer)
• Bluetooth wireless technology menu
• Display orientation and contrast
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NOTE
• You can administer a bolus manually on the pump (without using the meter). When the meter and
Bluetooth wireless technology are both turned on, the pump automatically transfers bolus information
to the meter. If bolus advice is used, it is important you enter carbohydrate information into the meter
for boluses delivered manually on the pump so that accurate bolus advice calculations are made.
• When the meter is in the Pump Menu, the meter beeps and/or vibrates similarly to the pump.
• When the meter and pump are communicating, any button press on the pump disables
communication.
• You can cancel a bolus (including an extended bolus) that is being delivered by the pump directly on
the pump or remotely on the meter (through the Pump Menu on the meter).
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3
Pump Screens on the Meter
Pump Screen
Corresponding Meter Buttons
Return to Main Menu
Bluetooth Wireless
Technology Icon
Back
Pump double button press
(d and a)
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In remote control mode, the Bluetooth wireless technology icon appears on the meter screen and on the
pump screen.
To control the pump using the meter, you must be in the Pump Menu. From the Pump Menu, use the
corresponding meter buttons to scroll through the pump menus and submenus (the same as you would
on the pump). Instructions for how to deliver a standard bolus, how to program a temporary basal rate
(TBR), and how to change the basal rate profile using the meter are provided in the following sections. For
information on how to use the pump, see the pump User Guide.
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3
Delivering a Bolus – Standard Bolus
To Program a Standard Bolus Remotely Using the Meter
1.
2.
3.
j From the Main Menu, select
Pump and press =.
j Repeatedly press and release
< until the STANDARD BOLUS
screen appears.
j Press > to select the Standard
Bolus menu.
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4.
5.
6.
j Press x to increase or z to
decrease the bolus amount.
j When the correct bolus
amount is displayed, press > to
confirm the bolus amount.
j The Standard Bolus icon blinks
for 5 seconds (bolus delivery
start delay). The meter beeps
three times and vibrates once,
then the pump begins to
deliver the bolus amount.
A countdown of the remaining
bolus amount to be delivered
appears on the meter display.
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3
Cancelling a Standard Bolus
You may cancel a Standard bolus delivery.
Time
Cancelling the Bolus
Result
When programming a Standard
j If you do not press any meter
A bolus is not delivered.
bolus (the bolus amount blinks on buttons for approximately
the screen)
20 seconds, the meter returns to
the Pump Run screen.
j Exit the BOLUS AMOUNT screen
and return to the STANDARD
BOLUS screen by pressing
. or by pressing < and x
simultaneously.
j Set the bolus amount to 0.0
units. Press > to exit the BOLUS
AMOUNT screen.
During the bolus delivery start
delay (Standard bolus icon is
blinking)
j Press x or z. The meter beeps
and displays the pump warning
W8: BOLUS CANCELLED. Press
> twice to confirm and mute the
warning. The meter then returns
to the Pump Run screen.
A bolus is not delivered.
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Time
Cancelling the Bolus
Result
During bolus delivery (meter is
j Press and hold x or z for
Bolus delivery is interrupted and
counting down the bolus amount) 3 seconds until the meter beeps. stopped.
The meter displays the pump
warning W8: BOLUS CANCELLED.
Press > twice to confirm and
mute the warning. You can view
the actual bolus amount that
was delivered prior to the bolus
cancellation by viewing the pump
bolus history.
For more information, see the pump User Guide. Ensure the bolus cancellation was intended and
program a new bolus, if necessary.
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3
Programming a Temporary Basal Rate (TBR)
1.
2.
3.
j From the Main Menu, select
Pump and press =.
j Repeatedly press and release
< until the TEMPORARY BASAL
RATE (TBR) screen appears.
j Press > to select the
Temporary Basal Rate (TBR)
menu.
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4.
5.
6.
j Press x or z to increase or
decrease the TBR.
j When the correct TBR
percentage is selected,
press <.
The TBR DURATION screen
appears.
j Press x or z to set the
duration time.
j Press > to save the changes.
The Run screen with the TBR
appears.
The new TBR is activated. The
meter beeps when the activation
occurs.
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3
NOTE
• If a TBR is not currently active, the TBR percentage is set to 100 %.
• When a TBR is active, it remains in effect even if the basal rate profile is changed.
• A TBR can only be programmed when the pump is in RUN mode.
• When a TBR is active, the pump beeps and vibrates every hour. The meter beeps and vibrates if the
meter is in the pump mode (in a Pump screen).
• For more information about programming a TBR, see the pump User Guide.
At the end of a TBR, the pump warning W7: TBR OVER appears. For more information about pump warnings
and errors, see the pump User Guide.
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Cancelling a Temporary Basal Rate
Situation
Cancelling the Temporary Basal Rate
Result
When programming a TBR
j If you do not press any meter buttons
The pump continues to
for approximately 20 seconds, the meter
deliver the normal basal
returns to the Pump Run screen.
rate.
j Return to the TEMPORARY BASAL RATE
(TBR) screen by pressing . or by pressing
< and x simultaneously.
j Set the TBR percentage to 100 %. Press >
to exit the TBR PERCENTAGE screen.
During the delivery of the TBR
j Press .. The meter beeps and returns to The TBR is cancelled and
the pump delivers the
the Pump Run screen.
j You can put the pump in Stop mode.
normal basal rate.
The TBR delivery is cancelled as well as
any Extended or Multiwave bolus that is
currently running. Your meter displays the
pump warning W6: TBR CANCELLED. Press
> twice to confirm and dismiss the warning.
For more information, see the pump User Guide.
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3
Changing a Basal Profile
1.
2.
3.
j From the Main Menu, select
Pump and press =.
j Repeatedly press and release
< until the BASAL RATE
SELECTION screen appears.
j Press > to select the Basal
Rate Selection menu.
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4.
j Press x or z to select the
basal rate profile. The basal
rate profile number and the
basal rate total amount appear.
j When the correct basal rate
profile appears, press > to
select it.
For more information, see the pump User Guide.
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3
3.4 Managing Pump Errors, Warnings, and Reminders with
the Meter
If the meter is off when a pump error, warning, or reminder occurs and you turn on the meter, after
communication to the pump is established:
• The meter goes directly to the Pump screen.
• Pump errors, warnings, and reminders appear on the meter screen.
• You can mute or confirm the pump error, warning, or reminder on the meter or the pump.
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Cartridge Low Warning
Cartridge Empty Error
Follow the instructions in the
pump User Guide for changing
the insulin cartridge.
When the contents of the
insulin cartridge on the pump
have dropped to 20 units of
insulin, the pump warning W1:
CARTRIDGE LOW appears.
j When the warning appears
on the meter Pump screen,
press > twice to snooze and to
confirm the warning.
j Change the cartridge before it
is empty.
When the insulin cartridge
is empty, the pump error
E1: CARTRIDGE EMPTY appears.
j You must change the cartridge
immediately. Follow the
instructions in the pump User
Guide for changing the insulin
cartridge.
j Press > twice to snooze and
confirm the error.
For more information about pump errors, warnings, and reminders, see the pump User Guide.
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4
4
Communication between the ACCU-CHEK
Aviva Combo Meter and ACCU-CHEK
Spirit Combo Pump
4.1 Overview
4.2 Turning Bluetooth® Wireless Technology On/Off
4.3 Using the System While Traveling
4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump
4.5 Cancelling the Pairing of the Meter and Pump Prompt
56
57
60
61
67
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4.1 Overview
The meter and pump use Bluetooth wireless technology to communicate. If you are experiencing
communication problems between the meter and pump, it is recommended you go directly to the
pump and operate the pump manually. For more information on troubleshooting communication between
the meter and pump, see Chapter 5, Troubleshooting.
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4
4.2 Turning Bluetooth® Wireless Technology On/Off
You may turn Bluetooth wireless technology on or off at any time using the meter.
Bluetooth Wireless Technology Icon Communication States
Icon
Communication State
Bluetooth wireless technology is on. The meter and pump are communicating.
Bluetooth wireless technology is off. The meter and pump are not communicating.
Bluetooth wireless technology is on. However, the meter and pump are not communicating.
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Turning Pump Communication (Bluetooth Wireless Technology) On or Off
Main Menu > Settings > Meter > Bluetooth
1.
2.
3.
j From the Main Menu, select
Settings and press =.
j Select Meter and press =.
j Select Bluetooth and press =.
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4.
4
NOTE
• You cannot use the meter to disable Bluetooth wireless
technology on the pump. You must manually turn off Bluetooth
wireless technology on the pump.
• If you change the pump time and date, the meter time and date
will automatically synchronize to match the pump the next time
communication is established.
j Press and hold * until the
Bluetooth icon changes.
For instructions on how to
turn on or turn off Bluetooth
wireless technology on the
pump, see the pump User
Guide.
• If the meter and pump are out of communication range, the
connection between the meter and pump may be lost.
• If you experience any communication problems, check the pump
to ensure Bluetooth wireless technology is turned on.
• Bluetooth wireless technology is turned off on the meter if the
battery level is low. If you see the battery low icon, you must
replace the batteries in order to turn on Bluetooth wireless
technology. However, you can still perform a blood glucose test.
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4.3 Using the System While Traveling
When traveling on an aircraft, you must ensure Bluetooth wireless technology is turned off on the meter and
on the pump prior to closure of the aircraft door. Electromagnetic emissions from the meter or pump could
interfere with the electronics systems of the aircraft.
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4
4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the
ACCU-CHEK Spirit Combo Pump
When obtained as a kit, the meter and pump are paired. If the meter and pump are not paired, see the
following instructions.
Pairing the Meter and Pump
1.
2.
Pump:
j Repeatedly press and release
d until the BLUETOOTH
SETTINGS screen appears.
j Press f.
Pump:
j Ensure Bluetooth wireless
technology is turned on. If
turned off, press a to turn
on.
j Press d.
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3.
4.
or
Pump:
j If the PAIRED DEVICE NONE
screen appears, proceed to
Step 6.
Pump:
j If the PAIRED DEVICE screen
appears, press d and
proceed to the next step.
Pump:
j To delete the device so the
pump can be paired with
another meter, press f.
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5.
Pump:
j Press f to confirm deletion
of the paired device.
6.
Pump:
j Press d.
4
7.
Meter:
j Ensure the meter is turned off.
j Press and hold * and then
press +.
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8.
9.
10.
Pump:
j Press f to initiate the pairing
process.
Pump:
j If NO DEVICE FOUND screen
appears, see the pump User
Guide for information on
troubleshooting.
j Select the meter to add. On the
pump, press f.
j Proceed to the next step for
instructions on how to place
the pump in pairing mode.
j To discontinue setting up
pairing, press +.
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11.
12.
Pump:
j The ADD DEVICE PAIRING
screen appears followed by
the ADD DEVICE ENTER PIN
CODE screen.
j Continue to the next step.
Meter:
The Pair with Pump screen
appears.
Enter the PIN Shown on the
Pump Display:
j Press =.
j Set the first number and press
=. Repeat until all of the
numbers have been entered.
4
j Ensure the PIN entered
matches the numbers on the
pump screen. Select Confirm.
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13.
NOTE
Meter:
j Turn off the meter. Once the
meter has turned off, the
pairing process is complete.
You may turn on the meter and
begin using it.
• A blood glucose test cannot
be performed during the
pairing process.
• The meter and pump remain
paired when the batteries
are removed and replaced.
• Only one meter can be
paired with one pump at a
time.
If the correct PIN was entered,
this Pair with Pump screen
appears on the meter, and the
DEVICE PAIRED screen appears
on the pump.
Pump:
j Press f to confirm the
pairing.
• If the meter is paired with
a pump, and you pair the
meter with another pump,
the meter is unpaired from
the first pump.
• If the meter is paired with a
pump and an unsuccessful
attempt is made to pair the
meter to another pump, the
meter is no longer paired
with the original pump.
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4
4.5 Cancelling the Pairing of the Meter and Pump Prompt
If the meter and pump are not paired, the meter prompts you to complete the pairing process each time you
turn on the meter unless you cancel the pairing process.
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1.
2.
3.
j Turn on the meter. The Pairing
setup has not been completed
screen appears.
j Select Cancel to cancel this
pairing process prompt.
Proceed to Step 2.
j Or, to begin the pairing process
select Next. Go to the section,
Pairing the ACCU-CHEK
Aviva Combo Meter with the
ACCU-CHEK Spirit Combo
Pump.
j Select Yes to cancel the pairing
process. Proceed to Step 3.
j Or, select No and return to
Step 1.
If you selected Yes to cancel
the pairing process, the Setup
Completed Successfully screen
appears.
j Select Next to go to the Main
Menu.
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5
5
Troubleshooting
5.1 Overview
5.2 Troubleshooting Communication Between the Meter and Pump
70
71
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5.1 Overview
For most communication problems between the meter and pump, the meter displays a message with a
short description of the symptom and, along with it, a proposed solution. This chapter goes into more detail
by describing the symptom, the possible cause, and the possible solution. If the possible solutions do not fix
the problem, contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578. For information about
troubleshooting the standard meter features, see the Standard Owner’s Booklet.
WARNING
Never make treatment decisions based on a warning or error message. If you have any concerns,
contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
NOTE
If you drop the meter or think it is not giving accurate results, make sure that your test strips and
control solution have not expired, and then perform a control test. For further assistance, contact
ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
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5
5.2 Troubleshooting Communication Between the Meter and
Pump
Display Shows
Bluetooth icon flashing
Bolus Advice
Bolus Advice data deleted
Possible Cause(s)
Possible Solution(s)
j Communication ended due to a
button press on the pump.
j Check the pump and continue operation
of the pump manually.
j Ensure the pump has Bluetooth wireless
technology turned on.
j Meter and pump are outside
communication range.
j Ensure the pump is within
communication range.
j Bolus advice data integrity cannot
be confirmed.
j Wait 8 hours for accurate bolus advice.
IMPORTANT:
• Insulin doses and meals taken before the Bolus Advice warning are no longer
reflected in the Bolus Advice calculation.
• The meter may not reflect the pump bolus history, however the bolus history
is available on the pump.
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Display Shows
Possible Cause(s)
Bolus Delivery Unavailable j The meter cannot communicate
with the pump.
j The pump is currently in Stop
mode.
Possible Solution(s)
j Retry or set to Manual Pump.
j Ensure the meter and pump have
Bluetooth wireless technology turned on.
j Ensure the meter and pump are within
communication range.
j If the low battery icon is displayed on
the meter, the meter cannot
communicate with the pump. Replace
the batteries.
j Take the pump out of Stop mode.
j The pump is currently delivering a j Allow the current bolus delivery to
bolus.
complete before delivering the next
bolus.
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5
Display Shows
Possible Cause(s)
Possible Solution(s)
Communication Lost
j Pump is out of range of the meter.
j Review or cancel the bolus on the pump.
j Ensure the meter and pump have
Bluetooth wireless technology turned on.
j Ensure the meter and pump are within
communication range.
j If the low battery icon is displayed on the
meter, the meter cannot communicate
with the pump. Replace the batteries.
Communication Warning
j Communication of bolus data from
the pump was not successful.
Therefore, pump data are not
available and the bolus data may
not be accurate.
j Communication of bolus data from
the pump was not successful.
Therefore, pump data are not
available and the active insulin
amount may not be accurate.
j Ensure the meter and pump have
Bluetooth wireless technology turned on.
j Ensure the meter and pump are within
communication range.
j If the low battery icon is displayed on the
meter, the meter cannot communicate
with the pump. Replace the batteries.
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Display Shows
Possible Cause(s)
Connection Lost
j The connection was lost between
j Restart the pairing process. See
the meter and the pump during the
Chapter 4, Communication Between the
pairing process. Therefore, the
ACCU-CHEK Aviva Combo Meter and
attempt to pair your meter and
ACCU-CHEK Spirit Combo Pump.
pump was unsuccessful.
j Ensure the meter and pump have
Bluetooth wireless technology turned on.
j If the low battery icon is displayed on the
meter, the meter cannot communicate
with the pump. Replace the batteries.
Incorrect Pump Time/Date
Possible Solution(s)
j Pump is out of range of the meter.
j Ensure the meter and pump are within
communication range.
j Pump time/date is incorrect.
j Set time/date on the pump (see pump
User Guide).
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5
Display Shows
Possible Cause(s)
Infrequent Pump
Communication
j At least two weeks have passed
since the meter and pump have
communicated.
j It is important to use Bluetooth wireless
technology communication between the
meter and pump regularly if you utilize
bolus advice.
j Ensure the meter and pump have
Bluetooth wireless technology turned on.
j Ensure the meter and pump are within
communication range.
j If the low battery icon is displayed on the
meter, the meter cannot communicate
with the pump. Replace the batteries.
Possible Solution(s)
Invalid PIN
j The wrong PIN was entered.
j Select OK and re-enter the PIN shown on
the pump display.
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Display Shows
Possible Cause(s)
Possible Solution(s)
Meter and Pump Not Paired j Meter and pump have not been
j You must pair the meter and pump to use
paired. You cannot use the pump
these features.
functions without pairing the meter j For instructions on how to pair the meter
and the pump.
and pump, see Chapter 4, Communication
Between the ACCU-CHEK Aviva Combo
Meter and ACCU-CHEK Spirit Combo
Pump.
Pairing Failed
j The attempt to pair the meter and
pump was unsuccessful.
j Restart the pairing process. See
Chapter 4, Communication Between the
ACCU-CHEK Aviva Combo Meter and
ACCU-CHEK Spirit Combo Pump.
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5
Display Shows
Possible Cause(s)
Pump Not Available
j The pump is out of the
j Ensure the meter and pump have
communication range of the meter.
Bluetooth wireless technology turned on.
j Ensure the meter and pump are within
communication range.
j If the low battery icon is displayed on the
meter, the meter cannot communicate
with the pump. Replace the batteries.
Possible Solution(s)
Time Mismatch
j The time or date on the meter is
more than 5 minutes different than
the time or date on the pump.
j The meter time and date were changed to
match the pump time. Ensure the time
and date are correct. If the time or date
are not correct, change the time and date
on the pump.
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WARNING
If you are experiencing communication problems between your meter and pump, it is recommended you
operate the pump manually and not use the meter to remotely control the pump. For assistance, please
contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
NOTE
For additional information on errors and warnings, see the Standard Owner’s Booklet.
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Appendices
Appendix A: Bolus Advice
Bolus advice is only available if you have set up bolus advice on the ACCU-CHEK Aviva Combo meter. For
instructions on how to set up bolus advice, see the Standard Owner’s Booklet.
Along with the basic blood glucose and carbohydrate values, there are several meter settings required to
optimize the bolus advice feature so the recommendations match your insulin needs to the greatest possible
extent. You must set up bolus advice correctly. Bolus advice is not available without these settings. It is
important to discuss the bolus advice settings with your healthcare professional.
NOTE
• Blood glucose and bG are interchangeable and mean the same thing.
• Bolus advice factors are items that influence the bolus calculations of the meter.
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Bolus Advice Meter Settings
This section contains an overview of the information that must be entered into the meter for accurate bolus
advice recommendations.
Carbohydrate Units
• Bolus advice recommendations are based on the units of carbohydrates selected.
• The right choice of carb units is important for bolus advice recommendations to be accurate.
• Carbohydrate units must be selected, whether or not you set up bolus advice.
The following carbohydrate units are available on the meter:
Abbreviation
Unit of Measurement
Gram Equivalent
g
Grams*
1 gram
KE
Kohlenhydrateinheit
10 grams
BE
Bread Equivalent
12 grams
CC
Carbohydrate Choice
15 grams
*Standard unit of measure in the U.S.
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Warning Limits
• You can select hyper (high) and hypo (low) blood glucose limits that best fit your needs.
• Whenever a blood glucose test result is above the hyper warning limit or below the hypo warning limit, the
meter displays a warning.
• Set the hyper warning limit greater than the target range of all time blocks.
• Set the hypo warning limit less than the target range of all time blocks.
• Bolus advice is not available if your blood glucose test result is below the hypo warning limit.
Time Blocks
Time blocks allow you to select settings to take into account the fact that your insulin requirement varies
throughout the day. Using the same values and factors for the day would not necessarily match your insulin
needs and could lead to inaccurate bolus advice recommendations.
The meter comes with five preset time blocks. You may set up to eight time blocks (time periods) depending
on your insulin needs. For each time block, you must set the target range, the carb ratio, and the insulin
sensitivity. You can define all of these values separately for each time block. The meter automatically takes
these values into account.
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Target Range
• The desired upper and lower limits of your blood glucose level considered acceptable as set by your
healthcare professional.
• The meter automatically calculates the target blood glucose level as the average between the upper and
lower blood glucose target limits.
• Talk with your healthcare professional to determine the appropriate target range.
Upper Blood Glucose Target Limit
• The upper limit of the blood glucose target range for the current time block.
• Blood glucose test results within the lower target limit and the upper target limit are considered within the
target range.
Lower Blood Glucose Target Limit
• The lower limit of the blood glucose target range for the current time block.
• Blood glucose test results within the lower target limit and the upper target limit are considered within the
target range.
Carb Ratio
• For the current time block, the carb ratio is the amount of insulin necessary to account for a certain number
of carbohydrates.
• Talk with your healthcare professional to determine the appropriate carbohydrate ratio.
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Insulin Sensitivity
• For the current time block, the insulin sensitivity (correction factor) is the amount of insulin necessary to
lower your blood glucose by a certain amount.
• Talk with your healthcare professional to determine the appropriate insulin sensitivity settings.
Your meter comes with the following preset time blocks:
Time Block
12-Hour Format
1
12:00 am–5:30 am
2
5:30 am–11:00 am
3
11:00 am–5:00 pm
4
5:00 pm–9:30 pm
5
9:30 pm–12:00 am
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Talk to your healthcare professional about setting up time blocks to help you manage your diabetes.
Here is a suggested pattern:
Time Block
Start Time
End Time
1. Night time
Midnight
The time you normally wake up
2. Breakfast
The time you normally wake up
1½ hours before you normally eat lunch
3. Lunch
1½ hours before you normally eat lunch
1½ hours before you normally eat dinner
4. Dinner
1½ hours before you normally eat dinner
1½ hours before you normally go to bed
5. Bedtime
1½ hours before you normally go to bed
Midnight
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Setting Up Time Blocks: Important Information
• Time blocks cover a 24-hour time period (from midnight to midnight).
• You can change the time period for any of the preset time blocks.
• When setting up bolus advice, you must complete and save the settings in at least one time block.
• Each time block must be at least 30 minutes long and can only be set in 30-minute increments.
• When you set the end time for a time block, the meter automatically sets this end time as the start time for
the next time block.
• You can set a different target blood glucose range, carb ratio, and insulin sensitivity for each time block.
• The target range for each time block must be within the hypo and hyper warning limits.
• When a time block is edited for the first time, the settings (target range, carb ratio, and insulin sensitivity)
are applied to all of the other time blocks.
Health Events
Health events allow you to select settings to take into account various activities or events that increase or
decrease your insulin need. Health events can be selected to indicate how you are feeling or what you are
doing that might affect your diabetes. The meter allows you the option of setting a percentage for each health
event except for Fasting. Fasting is not adjustable and does not scale bolus advice calculations. When a health
event is selected, the set percentage is used to increase or decrease the bolus insulin amount. Discuss the
appropriate percentage for each health event with your healthcare professional.
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Health events available on the meter are:
• Exercise 1
• Exercise 2
• Stress
• Illness
• Premenstrual
• Fasting
Bolus Advice Options
Meal rise, snack size, acting time, and offset time are bolus advice options. Below are detailed descriptions of
each of these settings.
Meal Rise
• During or after meals, an increase in blood glucose levels is considered normal within a certain range, even
though a meal bolus has been delivered. A meal rise is in effect for a specified time period.
• Enter the maximum increase in your blood glucose test result that is to be tolerated without an additional
correction bolus.
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Snack Size
• The snack size is the amount of carbohydrates that is not to be counted as a regular meal with the expected
meal rise.
Acting Time
• The period of time from the start of the meal rise or the delivery of a correction bolus until your blood
glucose level is expected to return to the target level.
• You can adjust the length of the acting time to fit your individual needs, within a specified time interval
(1½ hours to 8 hours).
Offset Time
• Offset time takes into account the expected delay for the blood glucose level to actually fall during the
acting time of insulin in the body. It describes the first time period within the acting time.
Active Insulin
• Bolus insulin that has been given to lower your blood glucose, but has not yet been fully used.
• The meter automatically calculates the active insulin amount and it is displayed on the bolus advice screen.
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Bolus Calculation
The bolus recommended by the bolus advice feature of the meter consists of two components: a
recommendation for a meal bolus that covers your food intake and a recommendation for a correction bolus
to adjust your blood glucose level if it is not within the target range. The correction bolus can be positive if
your current blood glucose level is above your target range or negative if it is below your target range.
Meal Bolus
A meal bolus is the amount of insulin that needs to be administered to cover the amount of carbohydrates you
are planning to eat. It is calculated as:
Meal Bolus = Carbohydrate Intake ×
Insulin
Carbohydrates
from carbohydrate ratio
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Correction Bolus
If your current blood glucose level is not within your target range, a correction bolus is recommended.
Blood Glucose Limits
bG Result
Hyper Warning
Upper Target Limit
Target
Lower Target Limit
Hypo Warning
Discuss your blood glucose limits with your healthcare professional.
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The calculation for the recommended correction bolus depends on your current blood glucose test result, your
insulin sensitivity for the current time block, and whether you are planning to eat.
Example Bolus Advice Calculations
Blood Glucose Level
Without Food Intake (No Carbs) Prior to a Meal
Above Upper Target Limit
(bG –Target bG) x Insulin Sensitivity
(bG –Target bG) x Insulin Sensitivity
+ Meal Bolus
Between Upper and Lower
Target Limit
No correction bolus is necessary.
(bG –Target bG) x Insulin Sensitivity
+ Meal Bolus. A correction bolus
can be negative.
Between Lower Target Limit
and Hypo Warning
No bolus recommended. The
correction bolus is negative.
(bG –Target bG) x Insulin Sensitivity
+ Meal Bolus. The correction bolus
is negative.
Below Hypo Warning
Hypo warning appears. It is
recommended you eat fast-acting
carbohydrates.
Bolus advice is not available.
Hypo warning appears. It is
recommended you eat fast-acting
carbohydrates.
Bolus advice is not available.
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Other Boluses
Subsequent Meal Boluses
If you are planning to eat several meals or snacks in a short period of time, you should administer a meal
bolus for each meal. The calculation is always the same as a meal bolus.
Correction Bolus After a Meal
After a meal, it is normal to allow for a rise of your blood glucose level even if you administered the correct
meal bolus. The allowed blood glucose level rise is called meal rise. After a certain period of time (offset time)
the meal rise decreases from its maximum until your blood glucose level has returned to the target level. The
period of time from the start of the meal rise until your blood glucose level returns to the target level is
defined as acting time. During this time, a correction bolus is only recommended if your blood glucose level
exceeds the current meal rise level.
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bG Level
Hyper
Acting Time
Offset Time
Meal Rise
Target Value
Target Range
Hypo
Current
bG Values
Time
Meal
Bolus
Bolus Not
Required
Currently Allowed bG Value:
Meal Rise
The dotted line shows how your blood glucose level might change after a meal bolus. Bolus advice tolerates
an increase in your blood glucose level within the meal rise range (green) without calculating an extra
correction bolus. When you enter a carbohydrate amount that is greater than the snack size, the meal rise
setting is added to the blood glucose target value. The shape of the meal rise (the width of the green area) is
determined by the offset time and the acting time.
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Subsequent Correction Boluses
The difference between your current blood glucose level and your target blood glucose level is called Delta
bG. A correction bolus administered according to the previous conditions covers this difference for a certain
period of time. As the correction bolus starts to take effect, your current blood glucose level should fall and
the covered Delta bG decreases after the offset time. At the end of the acting time, your blood glucose level
should return to the target limit. You receive a recommendation for another correction bolus only if your
current blood glucose test result exceeds the current Delta bG level.
bG Result
Offset
Time
Delta bG
(Correction
Insulin)
Time
Correction Bolus
Acting Time
Subsequent Correction Boluses: If your blood glucose test result is within Section 1 of the graph, a correction
bolus is not recommended. If your blood glucose test result is within Section 2 of the graph, a correction
bolus is recommended.
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Examples of Bolus Advice Recommendations
The following graphs provide differing examples of how bolus advice considers different factors when
calculations are made.
The currently allowed blood glucose value considers the following factors:
• Target Range Mean Value
• Meal Rise
• Correction Bolus
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After a Correction Bolus
bG Level
Hyper
Acting Time
Offset Time
Corrected bG
Target Value
Target Range
Hypo
Current
bG Values
Time
Bolus
Bolus Not
Required
Currently Allowed bG Value:
Corrected bG
The above diagram shows an example of the effect of this rule. The first correction bolus at 12:00 pm
remains active during the acting time (the width of the blue area). If the blood glucose value at 2:00 pm falls
below the currently allowed blood glucose value (top of the blue area), another correction bolus is not
calculated.
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bG Level
Hyper
Target Value
Target Range
Hypo
Current
bG Values
Time
Bolus
When a blood glucose test result is greater than the currently allowed blood glucose value, a bolus is
calculated (light blue) that only considers the difference between the current blood glucose value (orange
dots) and the currently allowed blood glucose value (the top of the blue area).
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Acting Time
bG Level
Hyper
Offset Time
Meal Rise
Target Value
Target Range
Hypo
Current
bG Values
Time
Meal
Bolus
Bolus Not
Required
Currently Allowed bG Value:
Meal Rise
Subsequent Meals
If you eat several meals in a row, the meal rise is restarted for each new meal bolus.
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Appendix B: Bolus Advice Calculations
The Mathematical Basis for Bolus Calculations
The following is a list of the most important formulas and the calculation principles on which bolus advice is
based. It is difficult to accurately calculate a bolus yourself using these formulas when the acting time and
offset time of recent meals and correction boluses are considered.
Carbohydrate Suggestion
This calculation is made when the blood glucose test result falls below the hypo warning limit. It is based
on the other values defined for the current time block and the result is calculated as a carbohydrate intake
recommendation.
Carbohydrates = ( Target Range Mean Value – Current bG) ×
according to time block definition
Insulin
Δ bG
from insulin sensitivity
×
Carbohydrates
Insulin
from carbohydrate ratio
NOTE:
• A minimum amount of 12g (or equivalent BE, KE, or CC units) is always given. If the calculated value
is below 12g, then 12g is used.
• The carbohydrate suggestion is displayed in the carb unit of measure you have selected (g, BE, KE, or
CC).
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Meal Bolus
The following formula is used to calculate the bolus for meals:
Meal Bolus = Carbohydrate Intake ×
Insulin
Carbohydrates
from carbohydrate ratio
Currently Allowed Blood Glucose Value
The target range average value used in the calculation of the correction bolus, as shown below, changes with
the definition for the time blocks.
Consequently, the currently allowed blood glucose value is calculated as follows:
Currently Allowed
Target Range Mean Value + Meal Rise +
Blood Glucose Value =
according to time block definition
current
active meal
∑
Blood Glucose Range Covered
by Correction Bolus
currently acting correction boluses
When no meal rise or correction bolus acting time is currently in effect, a value of “0” is substituted for these
parameters in the formula.
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Correction Bolus
Generally, a correction bolus is only calculated if the current blood glucose value is above the hypo bG
warning limit and outside the target range. If the current blood glucose value is above the target range, the
currently allowed blood glucose value must also be exceeded. Only correction boluses greater than “0” trigger
a corresponding acting time.
Insulin
Δ bG
Correction Bolus = (Current bG – Currently Allowed bG) ×
from insulin sensitivity
The blood glucose correction portion depends on the following requirements:
• If current bG > currently allowed blood glucose value, then blood glucose correction portion = current bG
– currently allowed blood glucose value
• If current bG > hypo warning limit and current bG < target range lower limit, then bG correction portion =
current bG – target range average value
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Correction Bolus with Carbohydrate Intake
Whenever carbohydrates have been entered, the related meal bolus is always offset against any (even
negative) correction bolus.
When a meal is eaten, the correction bolus is also calculated for blood glucose test results that fall within the
target range if:
• The current blood glucose test result falls below the target range average value, or
• The current blood glucose test result is above the currently allowed blood glucose value.
Since your pump can only deliver insulin, mathematically negative overall boluses are displayed as “0”.
Active Insulin
The active insulin field shows you if a prior bG correction bolus may possibly reduce your current bolus
calculation.
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Appendix C: Explanation of Symbols
You may encounter the following symbols on the packaging, on the type plate (back of meter), and in the
instructions for the ACCU-CHEK Aviva Combo meter, shown here with their meaning.
w
Caution, refer to safety-related notes in the instructions for use accompanying this product.
Global Trade Item Number
Federal law (USA) restricts this device to sale by or on the order of a physician
per 21 CFR 801.109.*
1.5V AAA
* Code of Federal Regulations
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Appendix D: Limited License
CAUTION
A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK AVIVA COMBO SYSTEM—READ CAREFULLY THE
LIMITATIONS RECITED BELOW.
The ACCU-CHEK Aviva Combo system (meter, including the code key, and test strips) and its use are protected
by U.S. Patent Nos. 6,645,368 (expires 22-December-2017); 7,276,146 (expires 4-October-2022); 7,276,147
(expires 4-October-2022); 7,407,811 (expires 9-May-2020); 7,452,457 (expires 2-May-2026); 7,488,601
(expires 1-February-2026); 7,494,816 (expires 29-December-2019); 7,569,126 (expires 28-December-2026);
7,604,721 (expires 12-August-2026); 8,298,401 (expires 4-October-2022); 8,303,801 (expires
4-October-2022); and 8,329,026 (expires 4-October-2022). A license to use the ACCU-CHEK Aviva Combo
system is required until the expiration of the last-to-expire patent listed above and is only granted when the
ACCU-CHEK Aviva Combo meter is used with the ACCU-CHEK Aviva Plus test strips and ACCU-CHEK Aviva Plus
code keys.
ACCU-CHEK Aviva Plus test strips are provided with a specifically matched ACCU-CHEK Aviva Plus code key.
These test strips and code keys are specifically manufactured for operation with the ACCU-CHEK Aviva Combo
meter. Use of other test strips with an unmatched code key or even with the matched code key supplied by
another manufacturer may prevent or impair the proper function of the ACCU-CHEK Aviva Combo system.
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Using the ACCU-CHEK Aviva Combo system indicates your acceptance of the restricted license to use
the ACCU-CHEK Aviva Combo system only with ACCU-CHEK Aviva Plus test strips and the corresponding
ACCU-CHEK Aviva Plus code key. If you do not agree to the terms and conditions of the restricted license, you
may return, at the place of purchase, the unused ACCU-CHEK Aviva Combo system for a full refund. If you
have any questions, please call the ACCU-CHEK Customer Care Services Center at 1-800-688-4578.
Except where prohibited by statute, all warranties covering the ACCU-CHEK Aviva Combo system are voided
by use of the ACCU-CHEK Aviva Combo system with any test strips or code keys other than ACCU-CHEK
Aviva Plus test strips or code keys.
Patent Information
U.S. Pat.:http://www.roche-diagnostics.us/patents
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WARNING
A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK FASTCLIX SYSTEM (device and lancet drums).
READ CAREFULLY THE LIMITATIONS RECITED BELOW.
The ACCU-CHEK FastClix system (device and lancet drums) and its use are protected by U.S. Patent Nos.
7,322,998 (expires 3-March-2020) and 7,785,338 (expires 5-January-2026). A license to use the ACCU-CHEK
FastClix system is required until the expiration of the last-to-expire patent listed above and is only granted
when ACCU-CHEK FastClix lancet drums are used with the ACCU-CHEK FastClix device.
ACCU-CHEK FastClix lancet drums are high precision components that are produced to the close tolerances
required for satisfactory operation with the ACCU-CHEK FastClix device. Use of other lancet drums with the
ACCU-CHEK FastClix device may prevent or impair proper function of the ACCU-CHEK FastClix device.
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Using the ACCU-CHEK FastClix device indicates your acceptance of the restricted license to use the
ACCU-CHEK FastClix device only with ACCU-CHEK FastClix lancet drums. If you do not agree to the terms and
conditions of the restricted license, you may return, at the place of purchase, the unused ACCU-CHEK FastClix
device for a full refund. If you have any questions, please call the ACCU-CHEK Customer Care Services Center
at 1-800-688-4578.
Except where prohibited by statute, all warranties covering the ACCU-CHEK FastClix device are voided by use
of the ACCU-CHEK FastClix device with any lancet drums other than ACCU-CHEK FastClix lancet drums.
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Index
A
acting time, 87
active insulin, 87
aircraft, See Bluetooth wireless technology,
using while traveling
B
basal profile, changing, 51–52
Bluetooth wireless technology,
communication states, 57
turning on or off, 58–59
using while traveling, 60
bolus advice,
meter screen features, 13
overview, 8–9
bolus advice calculations,
carbohydrate suggestion, 98
correction bolus, 100
correction bolus with carbohydrate intake,
101
currently allowed blood sugar value, 99
meal bolus, 99
bolus advice options, 86–87
bolus advice recommendations, examples,
94–97
bolus amount, adjust, 15
bolus calculation,
correction bolus, 89
examples, 90
meal bolus, 88
bolus, delivery using bolus advice, 14–22
button functions, 36–37
107
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C
carbohydrate units, 80
carb ratio, 82
carbs amount, 14
cartridge,
empty, 54
low, 54
communication, meter and pump,
overview, 34–37, 56
troubleshooting, 71–78
correction bolus, 91–93
D
deliver a bolus, See bolus, delivery using bolus
advice
diary, updating bolus information, 31
E
extended bolus,
delivery using bolus advice, 19
description, 28
H
health events, 14, 85–86
I
insulin sensitivity, 83
L
lower blood sugar target limit, 82
M
manual bolus,
insulin pen/syringe delivery using bolus
advice, 20–22
pump delivery using bolus advice, 20
manual pump bolus, description, 28
meal rise, 86
multiwave bolus,
delivery using bolus advice, 17–18
description, 27
108
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O
offset time, 87
P
pairing, delete device, 62
pairing meter with pump, 61–66
pairing prompt, cancelling, 67–68
pen bolus, description, 28
PIN, enter into meter, 65
pump control using meter, 38–40
pump screens on meter, features, 41–42
S
safety information,
bolus advice, 10–12
bolus delivery, 22–23, 29
snack size, 87
standard bolus,
cancel programmed meter delivery, 45–46
delivery using bolus advice, 15–16
description, 27
program delivery through meter, 43–44, 47,
51
symbols, explanation, 102
synchronize, meter with pump, 31
syringe bolus, description, 28
109
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T
target range, 82
temporary basal rate (TBR),
cancel programmed TBR, 50
program through meter, 47–49
time blocks, 81, 83–85
troubleshooting, See communication, meter and
pump, troubleshooting
U
upper blood sugar target limit, 82
W
warning limits, 81
warnings, pump, 53–54
warranty. See Standard Owner’s Booklet for
ACCU-CHEK Aviva Combo Blood Glucose Meter
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111
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112
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LAST UPDATE: 2015-06
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Aviva Combo
00048010156/D-0615
This file may not print or view at 100%.
Die lines and color breaks do not print.
© 2015 Roche Diabetes Care
Assembled in USA.
Distributed by:
Roche Diabetes Care, Inc.
Indianapolis, IN 46256
Phone: 1-800-280-7801
Fax: 1-888-810-0758
53778_00048010156_D.indb 1
ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK
AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and
FASTCLIX are trademarks of Roche.
Aviva
AvivaCombo
Combo
Roche USA – 53778
V6/1 – 00048010156/D – Black
Roche USA – 53778
V6/2 – 00048010156/D – Cyan
Roche USA – 53778
V6/3 – 00048010156/D – Magenta
Roche USA – 53778
V6/4 – 00048010156/D – Yellow
BLOOD GLUCOSE METER
Roche USA – 53778
V6/5 – 00048010156/D – PMS 287
Advanced Owner’s Booklet
for Self-Testing Only
Roche USA – 53778
V6/6 – 00048010156/D – PMS 5445
The Bluetooth® word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc. and any
use of such marks by Roche is under license.
All other product names and trademarks are the
property of their respective owners.
6/11/15 8:50 AM
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