Accu-Chek Aviva Combo Advanced Owners Manual EN

Accu-Chek Aviva Combo Advanced Owners Manual EN

Aviva Combo

©2013 Roche Diagnostics

Assembled in USA.

Distributed by:

Roche Health Solutions Inc.

11800 Exit 5 Parkway, Suite 120

Fishers, IN 46034

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.

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. Other trademarks and product names are the property of their respective owners.

BLOOD GLUCOSE METER

Advanced Owner’s Booklet for Self-Testing Only

This file may not print or view at 100%.

Die lines and color breaks do not print.

Roche USA – 51639

V6/1 – 00048010156/C – Black

Roche USA – 51639

V6/2 – 00048010156/C – Cyan

Roche USA – 51639

V6/3 – 00048010156/C – Magenta

Roche USA – 51639

V6/4 – 00048010156/C – Yellow

Roche USA – 51639

V6/5 – 00048010156/C – PMS 287

Roche USA – 51639

V6/6 – 00048010156/C – PMS 5445

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LAST UPDATE: 2012-08

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Before You Start Testing

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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Roche USA – 51639

V4/1 –

00048010156/C

– Black –

Roche USA – 51639

V4/2 –

00048010156/C

– Cyan –

Roche USA – 51639

V4/3 –

00048010156/C

– Magenta –

Roche USA – 51639

V4/4 –

00048010156/C

– Yellow –

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

Introduction

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

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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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Appendices

Appendix A: Bolus Advice

Appendix B: Bolus Advice Calculations

Appendix C: Explanation of Symbols

Appendix D: Limited License

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:

• Getting Started Guide:

Use this booklet to set up the meter.

• Standard Owner’s Booklet:

Use this booklet for instructions on how to operate the standard features of the meter.

• Advanced Owner’s Booklet:

Use this booklet for instructions on how to operate the advanced features of the meter.

This booklet includes information about:

• Taking bolus advice

• Administering a bolus

• Using the ACCU-CHEK Aviva Combo meter with the

ACCU-CHEK Spirit Combo pump

• Communication between the ACCU-CHEK

Aviva Combo meter and the ACCU-CHEK

Spirit Combo pump

• 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

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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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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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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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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1.3 Calculating and Delivering a Bolus Using Bolus Advice

bG Test Result

Active Insulin

Carb Entry

Health Event Entry

Bolus Type

Recommended Bolus

Amount

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To Deliver a Bolus

Main Menu > Bolus Advice

1.

j From the Main Menu, select

Bolus Advice and press = .

2.

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

Standard Owner’s Booklet for information on how to perform a blood glucose test. When the detailed bG Result screen appears, select Bolus.

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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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

3.

To Deliver a Standard Bolus

j

Select the Type entry field and press = . j Select Standard and press = .

To confirm the entries, select

Confirm.

4.

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.

To Deliver a Multiwave Bolus

j

Select the Type entry field and press = . j Select Multiwave and press

=

.

To confirm the entries, select

Confirm.

7.

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

=

.

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.

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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.

To Deliver an Extended Bolus

j

Select the Type entry field and press = . j Select Extended and press = .

To confirm the entries, select

Confirm.

10.

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.

11.

j

Select Menu to go to the Main

Menu.

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.

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.

WARNING

Start the delivery of the exact bolus amount on the pump within 10 minutes. See

WARNING at the end of this section.

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1

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.

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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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

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 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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2.3 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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2.4 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

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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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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3.2 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.

3

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

x a j

Function

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 j

Cycles through menus, functions, and information screens

> f 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 Function

.

d and a j

Exits menus, function screens, and information screens without saving your changes j

Move to the previous screen

,

None 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:

• 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

3

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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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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)

3

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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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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.

3

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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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Cancelling a Standard Bolus

You may cancel a Standard bolus delivery.

Time Cancelling the Bolus

When programming a Standard bolus (the bolus amount blinks on the screen)

During the bolus delivery start delay (Standard bolus icon is blinking) j If you do not press any meter buttons for approximately

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.

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.

Result

A bolus is not delivered.

A bolus is not delivered.

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3

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Time

During bolus delivery (meter is counting down the bolus amount)

Cancelling the Bolus Result

j

Press and hold x

or z

for

3 seconds until the meter beeps.

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.

Bolus delivery is interrupted and stopped.

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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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.

3

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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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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

When programming a TBR

During the delivery of the TBR

Cancelling the Temporary Basal Rate Result

j If you do not press any meter buttons for approximately 20 seconds, the meter returns to the Pump Run screen.

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.

The pump continues to deliver the normal basal rate.

j Press .

. The meter beeps and returns to the Pump Run screen.

j

You can put the pump in Stop mode.

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.

The TBR is cancelled and the pump delivers the normal basal rate.

For more information, see the pump User Guide.

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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.

3

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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.

52

For more information, see the pump User Guide.

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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

Follow the instructions in the pump User Guide for changing the insulin cartridge.

Cartridge Empty Error

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 j immediately. Follow the instructions in the pump User

Guide for changing the insulin cartridge.

Press

>

twice to snooze and confirm the error.

54

For more information about pump errors, warnings, and reminders, see the pump User Guide.

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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

4

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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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4.2 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.

4

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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.

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.

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.

• 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.

4

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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 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.

4

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.

Pump:

j

If the PAIRED DEVICE NONE screen appears, proceed to

Step 6.

or

Pump:

j

If the PAIRED DEVICE screen appears, press d and proceed to the next step.

4.

Pump:

j

To delete the device so the pump can be paired with another meter, press f.

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5.

6.

Pump:

j Press f to confirm deletion of the paired device.

Pump:

j Press d.

7.

Meter:

j Ensure the meter is turned off.

j

Press and hold

*

and then press

+

.

4

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8.

9.

10.

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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51639_00048010156_C.indb 64

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.

6/11/13 8:47 AM

4

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.

j

Ensure the PIN entered matches the numbers on the pump screen. Select Confirm.

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66

13.

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.

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.

NOTE

• 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 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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4.5 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.

4

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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

Troubleshooting

5.1 Overview

5.2 Troubleshooting Communication Between the Meter and Pump

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71

5

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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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5.2 Troubleshooting Communication Between the Meter and

Pump

Display Shows

Bluetooth icon fl ashing

Bolus Advice

Bolus Advice data deleted

Possible Cause(s)

j

Communication ended due to a button press on the pump.

Possible Solution(s)

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 confi rmed.

j Wait 8 hours for accurate bolus advice.

IMPORTANT:

• Insulin doses and meals taken before the Bolus Advice warning are no longer refl ected in the Bolus Advice calculation.

• The meter may not refl ect the pump bolus history, however the bolus history is available on the pump.

5

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Display Shows Possible Cause(s)

Bolus Delivery Unavailable j

The meter cannot communicate with the pump.

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 in Stop mode.

j The pump is currently delivering a bolus.

j Allow the current bolus delivery to complete before delivering the next bolus.

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Display Shows

Communication Lost

Possible Cause(s) Possible Solution(s)

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.

5

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Display Shows

Connection Lost

Possible Cause(s)

j

The connection was lost between the meter and the pump during the pairing process. Therefore, the attempt to pair your meter and pump was unsuccessful.

Possible Solution(s)

j

Restart the pairing process. See

Chapter 4, Communication Between the

ACCU-CHEK Aviva Combo Meter and

ACCU-CHEK Spirit Combo Pump.

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.

j Pump is out of range of the meter.

j Ensure the meter and pump are within communication range.

Incorrect Pump Time/Date j Pump time/date is incorrect.

j Set time/date on the pump (see pump

User Guide).

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Display Shows

Infrequent Pump

Communication

Invalid PIN

Possible Cause(s)

j

At least two weeks have passed since the meter and pump have communicated.

j

The wrong PIN was entered.

Possible Solution(s)

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. j

Select OK and re-enter the PIN shown on the pump display.

5

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Display Shows Possible Cause(s)

Meter and Pump Not Paired j

Meter and pump have not been paired. You cannot use the pump functions without pairing the meter and the pump.

Pairing Failed j

The attempt to pair the meter and pump was unsuccessful.

Possible Solution(s)

j

You must pair the meter and pump to use these features.

j For instructions on how to pair the meter and pump, see Chapter 4, Communication

Between the ACCU-CHEK Aviva Combo

Meter and ACCU-CHEK Spirit Combo

Pump.

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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Display Shows

Pump Not Available

Time Mismatch

Possible Cause(s)

j

The pump is out of the communication range of the meter.

j

The time or date on the meter is more than 5 minutes different than the time or date on the pump.

Possible Solution(s)

j

Ensure the meter and pump have

Bluetooth wireless technology turned on.

j Ensure the meter and pump are within communication range.

j

I f the low battery icon is displayed on the meter, the meter cannot communicate with the pump. Replace the batteries.

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.

5

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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 instructions on how to set up bolus advice, see the Standard Owner’s Booklet.

Aviva Combo meter. For

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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KE

BE

CC

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

Kohlenhydrateinheit

Bread Equivalent

Carbohydrate Choice

10 grams

12 grams

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

1

12-Hour Format

12:00 am–5:30 am

4

5

2

3

5:30 am–11:00 am

11:00 am–5:00 pm

5:00 pm–9:30 pm

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

1. Night time

Start Time

Midnight

End Time

The time you normally wake up

2. Breakfast

3. Lunch

4. Dinner

5. Bedtime

The time you normally wake up 1½ hours before you normally eat lunch

1½ hours before you normally eat lunch 1½ hours before you normally eat dinner

1½ hours before you normally eat dinner 1½ hours before you normally go to bed

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

Between Upper and Lower

Target Limit

Between Lower Target Limit and Hypo Warning

Below Hypo Warning

(bG –Target bG) x Insulin Sensitivity (bG –Target bG) x Insulin Sensitivity

+ Meal Bolus

No correction bolus is necessary.

(bG –Target bG) x Insulin Sensitivity

+ Meal Bolus. A correction bolus can be negative.

No bolus recommended. The correction bolus is negative.

Hypo warning appears. It is recommended you eat fast-acting carbohydrates.

Bolus advice is not available.

(bG –Target bG) x Insulin Sensitivity

+ Meal Bolus. The correction bolus is negative.

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

Off set Time

Acting Time

Target Value

Target Range

Hypo

Time

Current bG Values

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

Off set Time

Acting Time

Target Value

Target Range

Hypo

Time

Current bG Values

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

Time

Current bG Values

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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bG Level

Hyper

Off set Time

Acting Time

Target Value

Target Range

Hypo

Time

Current bG Values

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

Blood Glucose Value

= Target Range Mean Value + Meal Rise + according to time block definition

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.

Correction Bolus = (Current bG – Currently Allowed bG) ×

Insulin

Δ 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.

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

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108

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

I

H

health events, insulin sensitivity,

L

14 , 85–86

83 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

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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

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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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51639_00048010156_C.indb 2

LAST UPDATE: 2012-08

6/11/13 8:47 AM

Aviva Combo

©2013 Roche Diagnostics

Assembled in USA.

Distributed by:

Roche Health Solutions Inc.

11800 Exit 5 Parkway, Suite 120

Fishers, IN 46034

Phone: 1-800-280-7801

Fax: 1-888-810-0758

51639_00048010156_C.indb 1

ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK

AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and

FASTCLIX are trademarks of Roche.

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. Other trademarks and product names are the property of their respective owners.

BLOOD GLUCOSE METER

Advanced Owner’s Booklet for Self-Testing Only

This file may not print or view at 100%.

Die lines and color breaks do not print.

Roche USA – 51639

V6/1 – 00048010156/C – Black

Roche USA – 51639

V6/2 – 00048010156/C – Cyan

Roche USA – 51639

V6/3 – 00048010156/C – Magenta

Roche USA – 51639

V6/4 – 00048010156/C – Yellow

Roche USA – 51639

V6/5 – 00048010156/C – PMS 287

Roche USA – 51639

V6/6 – 00048010156/C – PMS 5445

6/11/13 8:47 AM

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