Accu-Chek Aviva Expert Owner Manual

© 2013 Roche Diagnostics

Assembled in USA.

Roche Diagnostics Corporation

9115 Hague Road

Indianapolis, IN 46256 www.accu-chek.com

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

AVIVA EXPERT, and FASTCLIX are trademarks of Roche.

BLOOD GLUCOSE METER

Standard Owner’s Booklet for Single Patient Use Only

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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 Expert system is limited to capillary whole blood testing.

Roche USA – 52123

V4/1 – 07006322001 – Black –

Roche USA – 52123

V4/2 – 07006322001 – Cyan –

Roche USA – 52123

V4/3 – 07006322001 – Magenta –

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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.”

WARNING

• The meter and lancing device are for single patient use only. Do not share them with anyone, including other family members, due to the risk of infection from bloodborne pathogens.

1,2

Do not use them on multiple patients!

• All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.

1,2

See Appendix E

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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 Expert system.

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About Bolus Advice

• Bolus advice is only available if you set up bolus advice on the ACCU-CHEK Aviva Expert meter. For information on how to set up bolus advice, see section 5.6 Setting Time Blocks, Health Events, Advice

Options: Bolus Advice Set Up.

• If you deliver a bolus without using bolus advice, you should enter the bolus advice into your diary. It is important that you enter all bolus insulin doses and the time they were administered, so the Bolus Advisor is assessing the total amount of insulin in your body. This step can help to reduce insulin stacking (the over-delivery of insulin) which causes hypoglycemia. It is also important that you enter the associated carbohydrate information into the diary in order to obtain accurate bolus advice recommendations. For information on how to enter information into the diary, see Section 4.3, Adding New Data.

WARNING

• Bolus advice should be used only if you are using U100, rapid-acting insulin for bolus dosing.

• Do not use bolus advice with Neutral Protamine Hagedorn (NPH) or any other intermediate-acting insulin.

• Do not use bolus advice if basal insulin dose is unstable.

• Long-acting insulin should not be used as a meal bolus or as a correction bolus.

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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.

• Refer to the Test Strip and Control Solution Package Inserts for additional health-related information.

• Failure to test could cause a delay in treatment decisions and lead to a serious medical condition. Contact your healthcare professional if you are unable to test.

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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


Introduction

The ACCU-CHEK Aviva Expert System

1 Understanding Your New System

1.1 Overview

1.2 The ACCU-CHEK Aviva Expert Meter at a Glance

1.3 Summary of Features

1.4 Screen Content and Navigation

2 Testing Your Blood Glucose

2.1 Overview

2.2 Using the ACCU-CHEK Aviva Expert System

2.3 Performing a Blood Glucose Test

2.4 Detailed Blood Glucose Test Results

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2.5 Understanding Blood Glucose Test Results

2.6 Unusual Blood Glucose Test Results

2.7 Symptoms of High or Low Blood Glucose

3 Control Testing

3.1 Overview

3.2 Why Perform Control Tests

3.3 About the Control Solutions

3.4 Performing a Control Test

3.5 Understanding Control Test Results

4 Managing Your Data

4.1 Overview

4.2 Viewing or Modifying Your Data

4.3 Adding New Data

4.4 Reporting Your Data

4.5 Downloading Your Data to a Computer

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5 Changing Meter Settings

5.1 Overview

5.2 Setting bG Test Reminders: After High bG, After Low bG, After Meal

5.3 Setting Alarm Clock Reminders: bG Test, Injection, Other

5.4 Setting Date Reminders: Dr. Visit, Lab Test

5.5 Setting Bolus Advice for the First Time

5.6 Setting Time Blocks, Health Events, Advice Options: Bolus Advice Set Up

5.7 Setting Warning Limits: Hyper, Hypo

5.8 Turning Key Lock On or Off

5.9 Setting the Language

5.10 Setting Units: Carbs, Insulin Increment, Max Bolus

5.11 Setting the Beeper, Vibrate, Key Sound

5.12 Setting the Time Format, Time, Date

5.13 Setting Time Blocks: Bolus Advice Not Set Up

5.14 Backlight Settings

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6 Icons, Reminders, Warnings, and Errors

6.1 Overview

6.2 List of Icons

6.3 Confirming a Reminder, Warning, or Error

6.4 List of Reminders

6.5 List of Warnings

6.6 List of Errors

7 Cleaning and Disinfecting the Meter and Lancing Device

7.1 Overview

7.2 Cleaning and Disinfecting the Meter

7.3 Cleaning and Disinfecting the Lancing Device

8 Maintenance

8.1 Overview

8.2 Changing the Batteries

8.3 Power-Saving Tips

8.4 Maintenance and Testing

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9 Troubleshooting

9.1 Overview

9.2 Troubleshooting the ACCU-CHEK Aviva Expert Meter

10 Technical Information

10.1 Overview

10.2 Product Limitations

10.3 Specifications

10.4 Product Safety Information

10.5 Disposing of the Meter, Strips, Lancets, and Batteries

10.6 Warranty and Limited License

10.7 Additional Supplies

10.8 Information for Healthcare Professionals

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Appendices

Appendix A: Abbreviations

Appendix B: Carb Units

Appendix C: Explanation of Symbols

Appendix D: Meter Settings and Range Limits

Appendix E: References

Glossary

Index

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Introduction

Whether the ACCU-CHEK Aviva Expert 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.

Should you have any questions, please contact one of our customer support and service centers. A listing is at the back of this booklet.

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This booklet includes information about:

• Understanding your new ACCU-CHEK Aviva Expert system

• Testing your blood glucose

• Control testing

• Managing your data

• Changing the meter settings

• Understanding the icons, reminders, warnings, and errors

• Cleaning and disinfecting the meter and lancing device

• Maintenance

• Troubleshooting

• Technical information

If you have questions, we are here to help. Just call ACCU-CHEK Customer Care Service Center at

1-800-688-4578. You can also visit www.accu-chek.com for diabetes management tools.

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The ACCU-CHEK Aviva Expert System

The ACCU-CHEK Aviva Expert meter is for quantitative blood glucose testing using ACCU-CHEK Aviva Plus test strips. The meter has many features including:

• Bolus advice calculation

• Daily time blocks that can be adjusted to fit your lifestyle

• Data management

• Data transfer

• Date reminders

• bG test reminders: Alarm clock reminders, Target bG levels, and Health events

• An electronic diary that allows you to enter meal time, carbs, health, and bolus information with your blood glucose test results

For detailed information about the features of the meter, see Chapter 1, Understanding Your New System.

NOTE

Blood glucose and bG are interchangeable and mean the same thing.

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Intended Use

The ACCU-CHEK Aviva Expert System is indicated as an aid in the treatment of insulin-requiring diabetes. The

ACCU-CHEK Aviva Expert System consists of the ACCU-CHEK Aviva Expert Meter, ACCU-CHEK Aviva Plus test strips, ACCU-CHEK Aviva control solutions, and ACCU-CHEK Bolus Advisor. The ACCU-CHEK Aviva Expert system is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients.

The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK

Aviva Expert blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU-CHEK Aviva Expert blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU-CHEK Aviva Expert blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should NOT be used with the ACCU-CHEK Aviva Expert blood glucose monitoring system. The

ACCU-CHEK Aviva Expert System is intended for prescription home use only.

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The ACCU-CHEK Aviva Expert meter is also indicated for the calculation of an insulin dose or carbohydrate intake based on user-entered data. The ACCU-CHEK Bolus Advisor, as a component of the Accu-Chek Aviva

Expert meter, is intended for use in providing insulin dose recommendations in response to blood glucose, health events, and carbohydrate input. The ACCU-CHEK Bolus Advisor is intended to provide direction for insulin adjustment within the scope of a pre-planned treatment program from a healthcare professional.

Before its use, a physician or healthcare professional must prescribe the ACCU-CHEK Aviva Expert System and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the ACCU-CHEK Bolus Advisor. Once programmed, a patient must consult with his/her physician or healthcare professional before making any changes to these ACCU-CHEK Bolus

Advisor settings.

The system includes:

• ACCU-CHEK Aviva Expert meter with three AAA batteries and pre-inserted black code key

• ACCU-CHEK Aviva Plus test strips and black code key*

• ACCU-CHEK Aviva control solution*

*May be sold separately

WARNING

• Any object coming into contact with human blood is a potential source of infection.

• Choking hazard. Small parts. Keep away from children under the age of 3 years.

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Why Regular Blood Glucose Testing Is Important

Testing your blood glucose regularly can make a big difference in how you manage your diabetes every day.

Discussing your results with your healthcare professionals and following their advice about medicine, exercise, and food plans can help you better control your diabetes.

Important Information About Your New Meter

• The meter is designed for testing fresh whole blood samples (for example, blood from your fingertip). The meter is for outside the body (in vitro) use. It should not be used to diagnose diabetes.

• This meter requires ACCU-CHEK Aviva Plus test strips. Other test strips will give inaccurate results.

• The meter comes with the time and date preset. You may need to change the time to your time zone.

• If you have followed the steps in this booklet but still have symptoms that do not seem to match your test results, or if you have questions, talk to your healthcare professional.

• The ACCU-CHEK Aviva Expert system is intended for single patient use only and should not be shared.

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1

Understanding Your New System

1.1 Overview

1.2 The ACCU-CHEK Aviva Expert Meter at a Glance

1.3 Summary of Features

1.4 Screen Content and Navigation

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1.1 Overview

Your new meter has several features to assist you in managing your diabetes. It is important you understand the features and how to operate the meter correctly.

NOTE

• This booklet shows sample screens. The screens in this booklet may look slightly different from the screens on the meter. If you have any questions about the meter screens, the ACCU-CHEK Customer

Care Service Center is open 24 hours a day, offering help in many languages. Call 1-800-688-4578.

• Blood glucose and bG are interchangeable and mean the same thing.

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1.2 The ACCU-CHEK Aviva Expert Meter at a Glance

Display

Shows menus, results, messages, and data stored in the diary.

Buttons

Press to enter menus or the diary, adjust settings, and scroll through results.

Left/Right Soft Keys

Press to select the menu or option above the key.

Power On/Off Button

Press to turn the meter on or off.

Test Strip Slot

Insert golden end of test strip here.

Backlight Button

Press to adjust the backlight level.

Infrared (IR) Window

Transfers data from the meter to a computer.

Code Key Slot

Black code key is preinserted here.

Battery Door

Remove the battery door by pushing the tab and pulling up the door.

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Batteries

Insert batteries according to the + and - symbols in the battery compartment.

Control Solution Bottle

(for example)

Test Strip

Yellow Window -

Touch blood drop or control solution here.

Golden End -

Insert this end of the test strip into the meter.

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Test Strip Container

(for example)

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1

Top View

Infrared (IR) Window

Code Key

(for example)

Side View

Pre-inserted black code key

NOTE

The meter is already coded and comes with a pre-inserted

black code key that you never need to change. Even if you use test strips from test strip boxes that contain another code key that is a different color or has different code numbers, you never need to change the black code key again.

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The meter has seven buttons and two soft keys.

Left Soft Key

Up Arrow

Enter

Left Arrow

Power On/Off

Right Soft Key

Right Arrow

Down Arrow

Backlight

NOTE

• You hear a sound every time an active button/soft key is pressed unless you turned off the key sound.

• Press

+

or insert a test strip to turn on the meter. If the meter displays the Time/Date screen, make the necessary changes and select Save.

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Table of Buttons and Soft Keys

Button

<

> x z

,

.

Name

Left Arrow

Right Arrow

Up Arrow

Function

j

Move or scroll to the left in a screen.

j

Move or scroll to the right in a screen.

j

Move or scroll up in a screen.

Down Arrow j

Move or scroll down in a screen.

Left Soft Key j

Select the option above the key on the display.

Right Soft Key j

Select the option above the key on the display.

=

*

Enter

Backlight j

Select a menu or option.

j

Save changes and exit the entry field.

j Adjust the backlight level (low, medium, high).

+

Power On/Off j

Turn the meter on and off.

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Table of Button Combinations

Button Combination

When the buttons are locked, press and hold , and .

until the Main Menu appears.

Name Function

Unlock Keys j

Unlocks the buttons.

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1.3 Summary of Features

Display

The meter has a full-color graphic LCD (Liquid Crystal Display) that displays current and historical information.

Backlight

• The backlight helps you read the information on the meter display under different lighting conditions.

• When the meter is turned on, the backlight is set to the medium level.

• Adjust the backlight level by pressing and releasing the backlight button.

• The backlight adjusts from low, to medium, to high, and back to low again.

• If set to the medium or high level and the buttons are not pressed for about 15 seconds, the backlight returns to the low level to save power.

• When the meter returns to the low level, pressing any button restores the previous backlight level.

• For more information about backlight settings, see Chapter 5, Changing Meter Settings.

• For more about power-saving tips, see Chapter 8, Maintenance.

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Key Lock

• The key lock feature allows you to lock all of the buttons on the meter, except for the power on/off button.

• The key lock serves as a safety measure against unintentional activation of meter functions.

• For more information, see Chapter 5, Changing Meter Settings.

Signal Settings

• The meter communicates reminders, warnings, and errors using sounds and vibrations.

• For more information, see Chapter 6, Icons, Reminders, Warnings, and Errors.

Blood Glucose Test

Your new meter allows you to enter detailed information for each blood glucose test to include:

• Meal time (Pre meal, Post meal, Bedtime, or Other)

• Carbs (the amount of carbohydrates you are intending to eat)

• Health events (Exercise 1, Exercise 2, Stress, Illness, Premenstrual, or Fasting)

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Bolus Advice (Optional)

• The term “bolus” refers to the delivery of insulin all at once rather than slowly throughout the day, usually used to compensate for meals or high blood glucose.

• Bolus advice calculates a bolus for you that is adapted to the time of day and your changing situations.

• This function is activated only if you set up bolus advice on the meter.

• For instructions on how to set up bolus advice, see Chapter 5, Changing Meter Settings.

WARNING

Before setting up bolus advice, it is very important to read all of the safety information in the Advanced

Owner’s Booklet and talk to your healthcare professional.

My Data

• Your new meter stores 1,000 records in the diary.

• You can view, modify, or add information to your diary.

• You can view blood glucose test averages, trends, standard day, standard week, and target tables and graphs of the data in the diary.

• You can view the data in graph or table format for the last 7, 14, 30, 60, or 90 days.

• For more information, see Chapter 4, Managing Your Data.

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Data Transfer

• You can transfer your data stored on the meter to a computer.

• For more information, see Chapter 4, Managing Your Data.

Warning Limits for Hyper and Hypo Blood Glucose Levels

• You can select hyper (high) and hypo (low) blood glucose limits that best fit your needs. Whenever a blood glucose test result is above or below this range, the meter displays a warning.

• In addition, Trend Graph screens indicate the hypo warning limit when displaying your blood glucose test results. For more information, see Chapter 4, Managing Your Data.

• The meter has default warning limits that can be adjusted. For more information, see Chapter 5, Changing

Meter Settings.

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Time Blocks

• Time blocks allow you to divide a day into different time periods.

• Setting time blocks to fit your own schedule helps you and your healthcare professional see how patterns in your blood glucose are affected by your daily activities and lifestyle.

• Time blocks can be set up with or without bolus advice.

• Talk to your healthcare professional about the best way to set up your time blocks to assist you in managing your diabetes.

• The meter has 5 default time blocks.

• You may set up to 8 time blocks.


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Without bolus advice, you need to consider the following when setting up time blocks:

• Determine the appropriate time range by reviewing the end time for each time block.

• Review the acceptable blood glucose target range (low and high) for each time block.

With bolus advice, you need to consider the following when setting up time blocks:

• Determine the appropriate time range by reviewing the end time for each time block.

• Review the acceptable blood glucose target range (low and high) for each time block.

• Determine your carb ratio (the amount of insulin needed to cover a given amount of carbohydrates) for each time block.

• Determine your insulin sensitivity (the amount of insulin needed to lower your blood glucose by a given amount) for each time block.

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Health Events

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, if you set up bolus advice. Fasting does not scale bolus advice calculations and is not adjustable.

Health events available on the meter are:

• Exercise 1

• Exercise 2

• Stress

• Illness

• Premenstrual

• Fasting

Discuss the appropriate percentage for each health event with your healthcare professional. For instructions on how to set up bolus advice, see Chapter 5, Changing Meter Settings.

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Blood Glucose Test Reminders (Optional)

The meter can be set up to remind you to retest your blood glucose after a high blood glucose test result, after a low blood glucose test result, or after a meal.

An after high blood glucose test reminder example:

• The meter is set up with a high bG threshold level of 240 mg/dL and with a reminder time of 60 minutes.

• You have a blood glucose test result higher than 240 mg/dL, perhaps 270 mg/dL.

• In 60 minutes, the meter reminds you to perform another blood glucose test.

The after meal bG test reminder is set up with a carb value and occurs when the carb value exceeds the snack size. Any of these blood glucose test reminders can be turned on or off individually, as needed. For more information, see Chapter 5, Changing Meter Settings.

Alarm Clock Reminders

• The meter has alarm clock reminders which can be used as a helpful way to remind you when to test throughout the day.

• In addition to “bG Test” and “Injection,” you can set reminders for “Other” for any other daily reminder.

• You can set up to 8 reminders per day.


Date Reminders

• The meter can be set up to remind you of upcoming appointments or dates, such as a “Dr. Visit” or a “Lab

Test.”


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1.4 Screen Content and Navigation

This section provides an explanation of how to understand and navigate the screens on the meter.

1

Each time the meter is turned on, this splash screen (ACCU-CHEK logo screen) is displayed for a short period of time.

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Features on the Main Menu:

Sound Icon

Appears when the beeper is turned on

Time

Menu Options

Vibrate Icon

Appears when vibrate is turned on

Date

Low Battery Icon

Appears when the meter batteries are low

NOTE

To select an item on a menu, press x

or z

to highlight (blue) the menu item and then press

=

.

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Features on a screen:

Title Bar

Primary menu title is displayed here.

Secondary Title Bar

When necessary, a secondary title bar appears. Secondary menu text is displayed here.

Left Soft Key Option

Press

,

to select the option above the button on the screen.

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Highlighted Option

When a menu choice or item is selected, it is highlighted in blue.

Scroll Bar

If there is more information available than fits on the screen, a vertical scroll bar appears on the right side of the screen.

Right Soft Key Option

Press

.

to select the option above the button on the screen.

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Information can be entered on some screens. Numerical entry fields appear as pop-up entry fields. When an option must be selected, it appears as a pop-up menu.

• To open a pop-up menu or entry field, press = .

• Press x

or z

to select the appropriate pop-up menu option or until the correct numerical entry is present, and then press

=

.

• Press and hold x

or z

to scroll faster.

Pop-Up Entry Field

Pop-Up Menu

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General Navigation Steps

To change the settings or enter information into the meter:

1.

j

Press x

or z

to select a menu option and press

=

.

j

Repeat the previous step as necessary.

52123_07006322001.indb 33

1

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2.

3.

j

Press x

or z

or

<

or

>

to select an option or a desired entry field and press = .

j

Press x

or z

to select the desired entry and press = .

j Repeat Steps 2 and 3, as necessary.

4.

j Select Save by pressing .

to save changes and return to the previous screen.

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2

Testing Your Blood Glucose

2.1 Overview

2.2 Using the ACCU-CHEK Aviva Expert System

2.3 Performing a Blood Glucose Test

2.4 Detailed Blood Glucose Test Results

2.5 Understanding Blood Glucose Test Results

2.6 Unusual Blood Glucose Test Results

2.7 Symptoms of High or Low Blood Glucose

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37

39

47

2

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2.1 Overview

It is important to understand how to perform a blood glucose test properly. You can perform a blood glucose test from your fingertip.

NOTE


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2.2 Using the ACCU-CHEK Aviva Expert System


Using ACCU-CHEK Aviva Plus Test Strips

• Only use ACCU-CHEK Aviva Plus test strips.

• Store the unused test strips in their original container. Do not remove test strips from the test strip container and put them into another container, such as a plastic bag, pocket, purse, wallet, etc.

• Immediately after you take out a test strip, securely close the container. This helps keep the test strips dry.

• Use the test strip immediately after you take it out of the container.

• Be sure to check the “Use by” date on the test strip container. Do not use the test strips after that date.

• If the “Use by” date is missing or cannot be read, do not use the test strips.

• Store the test strip container at room temperature between 36–86 °F. Do not freeze. Do not store the test strip container in rooms where the air is humid such as the kitchen, laundry room, or the bathroom.

Temperatures outside the required range, as well as moisture and humidity, can damage your test strips and lead to inaccurate results.

• Refer to the test strip package insert for system operating conditions.

• Do not apply blood or control solution to the test strip before you insert it into the meter. If the meter gives you a result before applying blood or control solution, do not act on that result.

• Do not reuse test strips. Once you have put control solution or blood on a test strip, throw it away. If you need to retest, use a new test strip.

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WARNING

Not following the precautions below can lead to inaccurate results:

• Do not store test strips in extreme temperatures or moisture areas (bathroom, kitchen, laundry room, car, or garage). Heat and moisture can damage your test strips.

• Do not bend, cut, or alter the test strips.

• Do not get dirt, food, or other material on the test strips.

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2.3 Performing a Blood Glucose Test

Before you perform your first blood test, ensure the meter is set up correctly and that you perform a control test. You need a meter with a pre-inserted black code key, a test strip, a lancing device, and a lancet.

WARNING

• During normal testing any blood glucose meter or lancing device may come in contact with blood. All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfection.

1,2

• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, bloodborne pathogens.

3

• The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from bloodborne pathogens.

1,2

• If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.

• It is important to keep the meter and lancing device clean and disinfected. For instructions on how to clean and disinfect the meter and lancing device, see Chapter 7, Cleaning and Disinfecting the Meter and Lancing Device.

• Wash hands thoroughly before and after handling the meter, lancing device, or test strips.

1,2,3

See Appendix E

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WARNING

• Do not change your treatment because of one blood glucose test result.

• NEVER ignore symptoms of high or low blood glucose.

NOTE

If you need to perform a control test, only use ACCU-CHEK Aviva control solutions. See Chapter 3, Control

Testing for more information about control testing.

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Performing a Fingertip Blood Glucose Test

Prepare > Check the use By Date > Insert Test Strip > Test Blood Sample > bG Test Result

1.

2.

3.

2

j

Wash and dry your hands. Dirty hands could affect results.

j

Prepare the lancing device for a fingertip test.

j Always use a new lancet with each test.

j

Check the Use By date on the test strip container. Do not use test strips past the Use

By date.

j

Insert the golden end of a test strip into the meter in the direction of the arrow. The meter turns on.

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4.

5.

6.

The Apply Sample screen appears. The test strip is ready for testing.

Fingerstick:

j

Perform a fingerstick with the lancing device.

Fingerstick:

j

Gently squeeze your finger to assist the flow of blood. This helps you get a blood drop.

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2

7.

8.

9.

j Touch the blood drop to the

front edge of the yellow window of the test strip. Do not put blood on top of the test strip.

When the test strip has enough blood, the Analyzing screen appears.

The result appears on the display.

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10.

Approximately 3 seconds later, the detailed bG Result screen appears.

j Remove and discard the used test strip.

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NOTE

• If the blood drop is too small, reapply pressure to get a sufficient blood drop.

• For more information regarding blood glucose test results, see Section 2.5, Understanding Blood

Glucose Test Results.

• To add detailed information to the blood glucose test (meal time, carbs, and health events) see

Section 2.4, Detailed Blood Glucose Test Results.

• If a test strip error occurs, remove and discard the used test strip and repeat the test with a new test strip.

• Be careful not to put any fluids into the test strip slot.

• The meter cannot be turned off when the following screens are displayed:

• Match Code to Vial

• Apply Sample

• Analyzing

• bG Result

• When a test strip is in the meter, the buttons are inactive. The buttons become active when you remove the test strip or when the test is complete.

• The meter turns off automatically in approximately 2 minutes if no buttons are pressed.

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NOTE

Other ways to start a blood glucose test:

• From the Main Menu, select bG Test and press = . Insert a test strip into the meter.

• When a reminder notification or the key lock icon is displayed, insert a test strip into the meter.

• From the Main Menu, select Bolus Advice and press = . If “bG Test” is displayed instead of an actual blood glucose value, then you can start a blood glucose test by selecting bG Test. If an actual blood glucose value is displayed, then you cannot start a blood glucose test using this process.

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2.4 Detailed Blood Glucose Test Results

The detailed bG Result screen displays the following information:

Test Time

Meal Time

Carbohydrates

Health Event

Active Insulin

Displayed only if bolus advice is activated.

Status Bar

Blood Glucose Test Result

Unit of Measure

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Detailed bG Results > Change Meal Time/Carbs/Health Events (Optional)

The detailed bG Result screen allows you to view and to add information to a blood glucose test result.

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How to Add Information to a Blood Glucose Test Result

To Change Meal Time:

j

Select the Meal Time entry field and press = .

j Select either Pre Meal, Post

Meal, Bedtime, or Other and press

=

.

To Change Carbs:

j Select the Carbs entry field and press = .

j

Set the number of carbs and press

=

.

To Change Health Events:

j Select the Health entry field and press = . j

Select either Exercise 1,

Exercise 2, Stress, Illness,

Premenstrual, or Fasting and press = .

Active Insulin Display:

The meter displays the calculated amount of Active

Insulin.

To save the changes and exit the detailed bG Result screen:

j

To return to the Main Menu, select Menu.

j To proceed to the Bolus Advice screen, select Bolus.

Bolus Advice is not available if:

j The blood glucose test result is below the hypo warning limit.

j

The detailed bG Result screen has been displayed for more than 5 minutes. The warning message “Bolus Advice

Timeout” is displayed. Select

OK to return to the detailed bG

Result screen.

For more information about bolus advice, see the Advanced

Owner’s Booklet.

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NOTE

• You can add information on the detailed bG Result screen for meal time, carbs, and health events.

• Review and, if necessary, update information for meal time, carbs, and health events to receive an accurate bolus recommendation.

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2.5 Understanding Blood Glucose Test Results

The bG Result screen displays the following information:

Test Time

Blood Glucose

Test Result

Test Date

Status Bar

Unit of Measure

NOTE

• If the dosed test strip is removed from the meter before results or errors are displayed, a blood glucose test result will not appear.

• After approximately 3 seconds, the meter displays the detailed bG Result screen (see Section 2.4,

Detailed Blood Glucose Test Results).

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Status Bar

The status bar on the bG Result screen indicates how the result compares to the target blood glucose range for the current time block. The following are status bar descriptions with sample displays:

Green indicates the result is within the target range for the current time block.

Yellow indicates the result is below the target range for the current time block. The result is not below the hypo warning limit.

Red with “Hypo” indicates the result is below the hypo warning limit.

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2

Light blue indicates the result is above the target range for the current time block. The result is not above the hyper warning limit.

Light blue with “Hyper” indicates the result is above the hyper warning limit.

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LO or HI Display

If “LO” is displayed, the test result may be below the measurement range.

j Contact your healthcare professional.

If “HI” is displayed, the test result may be above the measurement range.

j Contact your healthcare professional.

NOTE

Blood Glucose Warnings

If the blood glucose test results are outside the hyper or hypo warning limits, or outside the measurement range of the meter, then a warning is displayed after the bG Test Result screen. Select

OK to acknowledge a warning and continue.

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2.6 Unusual Blood Glucose Test Results

If your blood glucose test result does not match the way you feel, follow these steps:

Troubleshooting Checks

1. Are the test strips expired?

2. Has the cap on the test strip container always been closed tightly?

Actions

Discard the test strips if they are past the use by date.

Repeat the blood glucose test with an unexpired test strip.

Replace the test strips if you think the test strip container was uncapped for some time and repeat the blood glucose test.

Repeat the blood glucose test with a new test strip.

3. Was the test strip used immediately after it was removed from the test strip container?

4. Were the test strips stored in a cool, dry place?

5. Did you follow the directions?

6. Are the meter and test strips working properly?

Repeat the blood glucose test with a properly stored test strip.

Read Chapter 2, Testing Your Blood Glucose, and test again.

If you still have problems, contact ACCU-CHEK Customer

Care Service Center at 1-800-688-4578.

Perform a control test. See Chapter 3, Control Testing.

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7. Are you still unsure of the problem?

Actions

Contact ACCU-CHEK Customer Care Service Center at

1-800-688-4578.

After performing a control test and repeating a blood glucose test, if your blood glucose test results still do not reflect the way you feel, contact your healthcare professional immediately.

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2.7 Symptoms of High or Low Blood Glucose

Being aware of the symptoms of high or low blood glucose can help you understand your test results and decide what to do if they seem unusual. Hyperglycemia and hypoglycemia may include, but are not limited to the following symptoms:

• High blood glucose (hyperglycemia): increased thirst, frequent urination, blurred vision, drowsiness, and/or unexplained weight loss.

• Low blood glucose (hypoglycemia): anxiety, shakiness, sweating, headache, increased hunger, dizziness, pale skin color, sudden change in mood or irritability, fatigue, difficulty concentrating, clumsiness, palpitations, and/or confusion.

WARNING

• If you are experiencing any of these symptoms, test your blood glucose. If your blood glucose test result is displayed as LO or HI, contact your healthcare professional immediately.

•

The meter is designed to display blood glucose results from 20 to 600 mg/dL. If a result below 20 mg/dL or over 600 mg/dL appears on the display, call ACCU-CHEK Customer Care

Service Center at 1-800-688-4578.

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Comparing Your Meter Result to a Lab Result

A common question is how the blood glucose results on your meter compare to the lab results. Your blood glucose can change quickly, especially after eating, taking medication, or physical activity. If you test yourself in the morning and then go to the healthcare professional’s office for a blood glucose test, your results will probably not match, even if you are fasting. This is typically not a problem with your meter, it just means that time has elapsed and your blood glucose has changed.

If you want to compare your meter result to the lab result, you must be fasting. Take your meter to the healthcare professional’s office, and test yourself by fingerstick within five minutes of having blood drawn from your arm by a healthcare professional. Keep in mind that the lab uses different technology than the meter, and that blood glucose meters for self testing generally read somewhat lower than the lab result.

If you are fasting and you do a fingerstick test within five minutes of having your blood drawn, here are the general guidelines to compare your meter result to the lab result:

• If your blood glucose is below 75 mg/dL, your results generally should fall within ±15 mg/dL of the lab result.

• If your blood glucose is equal to or over 75 mg/dL, your results generally should fall within ±20 % of the lab result.

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3

Control Testing

3.1 Overview

3.2 Why Perform Control Tests

3.3 About the Control Solutions

3.4 Performing a Control Test

3.5 Understanding Control Test Results

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61

62

63

69

3

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3.1 Overview

This chapter describes how and when to perform a control test to ensure the accuracy of your blood glucose meter. It is recommended you complete a control test prior to performing a blood glucose test for the first time.

NOTE


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3.2 Why Perform Control Tests

Performing a control test lets you know the meter and test strips are working properly to give reliable blood glucose test results. You should perform a control test when:

• You open a new test strip box.

• You left the test strip container open.

• You want to check the meter and test strips.

• Your test strips were stored in extreme temperatures, humidity, or both.

• You dropped the meter.

• Your test result does not match how you feel.

• You want to check if you are performing the test correctly.

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3.3 About the Control Solutions

• Only use ACCU-CHEK Aviva control solutions.

• The meter automatically recognizes the control solution.

• The control test results are not displayed in the diary.

• Write the date you opened the control solution bottle on the bottle label. The solution is good for 3 months from that date or until the “Use by” date on the bottle label, whichever comes first.

• Do not use control solution that is past the “Use by” date.

• The solution can stain clothing. If you spill it, wash your clothes with soap and water.

• Close the bottle tightly after use.

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3.4 Performing a Control Test

The Control Result screen displays the following information:

Test Time

Control Result

Test Date

Unit of Measure

You need a meter with a pre-inserted black code key, a test strip, and control solution Level 1, Level 2, or both.

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Check the Use By Date > Insert Test Strip > Test Control Solution > Control Result

1.

2.

3.

j

Check the Use By date on the test strip container. Do not use test strips past the Use

By date.

j Insert the golden end of a test strip into the meter in the direction of the arrow. The meter turns on.

The Apply Sample screen appears. The test strip is ready for testing.

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4.

5.

6.

j

Select the control solution to test. You will enter the level later in the test.

j

Place the meter on a flat surface, like a table.

j

Remove the control bottle cap.

Wipe the tip of the bottle with a tissue.

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7.

8.

9.

66

j Squeeze the bottle until a tiny drop forms at the tip.

j

Touch the drop to the

front

edge of the yellow window of the test strip. Do not put control solution on top of the test strip.

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When the test strip has enough control solution, the Analyzing screen appears. j Wipe the tip of the bottle with a tissue and then cap the bottle tightly.

The control result appears on the display.

j

Select Level to display the control solution level pop-up menu.

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3

10.

11.

j

Select the control solution level and press

=

.

j

Remove and discard the test strip.

j

For information on understanding control test results, proceed to the next section, or select Menu to save this result and display the

Main Menu screen.

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NOTE

• If a test strip error occurs, remove and discard the used test strip and repeat the test with a new test strip.

• Be careful not to put any fluids into the test strip slot.

• When the Control Level screen is displayed and you select Cancel without selecting a control solution level, then No Entry is chosen. The meter stores the control test result along with No Entry and then the Detailed Control Result screen is displayed.

• When the Control Level screen is displayed and you turn off the meter, or if the meter auto-powers off, without selecting a control solution level, then No Entry is chosen. The meter stores the control test result along with No Entry.

•

Other ways to start a control test:

• From the Main Menu, select bG Test. Insert a test strip into the meter.

• When a reminder notification or the key lock icon is displayed, insert a test strip into the meter.

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3.5 Understanding Control Test Results

The detailed Control Result screen displays the following information:

Test Time

Control Result

Unit of Measure

Menu

Select Save to save result and display

Main Menu screen

Test Date

Control Solution Level

Result

Within range or Out of range

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Example

Range (mg/dL)

Level 1 25-55

Level 2 255-345 j

When the control test result is inside the range on the test strip container, the test strips and the meter are working properly.

Example Control Results

j

The label on your test strip container shows the acceptable ranges for both the Level 1 and the Level 2 control solutions. The test result you get should be inside this range. Ensure you select and compare the test result to the correct level of control. For the level selected, the meter displays whether the result is within or outside of the acceptable range.

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If the control test result is within the acceptable range, “Within range” appears on the detailed

Control Result screen.

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If the control test result is outside of the acceptable range,

“Out of range” appears on the detailed Control Result screen.

If “HI” is displayed, the control test result may be above the measurement range.

If “LO” is displayed, the control test result may be below the measurement range.

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If the meter stored No Entry for the control solution level, then

“---” appears with no indication of in or out of range.

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Out-of-Range Control Test Results

If your control test result is out of range, check this list to help to solve the problem:

Troubleshooting Checks Actions

1. Were either the test strips or control solutions expired?

2. Did you wipe the tip of the control solution bottle before use?

3. Were the caps on the test strip container and the control solution bottle always closed tightly?

4. Was the test strip used immediately after it was removed from the test strip container?

5. Were the test strips and control solutions stored in a cool, dry place?

Discard the test strips or control solutions if either is past the Use By date. If the control solution was opened more than 3 months ago, discard it. Repeat the control test with an unexpired test strip and an unexpired control solution.

Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution.

Replace the test strips or control solutions if you think either was uncapped for some time and repeat the control test.

Repeat the control test with a new test strip and a fresh drop of control solution.

Repeat the control test with a properly stored test strip and control solution.

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6. Did you follow the directions?

7. Did you chose the correct control solution level, either 1 or 2, when you performed the control test?

8. Are you still unsure of the problem?

Actions

Read Chapter 3, Control Testing, and repeat the control test. Contact ACCU-CHEK Customer Care

Service Center at 1-800-688-4578 if you still have problems.

If you chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container.

Contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

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4

Managing Your Data

4.1 Overview

4.2 Viewing or Modifying Your Data

4.3 Adding New Data

4.4 Reporting Your Data

4.5 Downloading Your Data to a Computer

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4

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4.1 Overview

Analyzing your blood glucose test results stored in the meter is an effective way for you and your healthcare professional to determine how well you are controlling your diabetes. This analysis is a valuable tool for making improvements to your diabetes management. The reports the meter displays help you get the most from your ACCU-CHEK Aviva Expert meter.

From the diary records stored in the meter, you are able to view a specific blood glucose test record with its attributes (e.g., meal time, carbs, health event, bolus. and basal insulin). In addition, for a specific diary record, you are able to change or add to its attributes.

The meter generates reports, such as blood glucose averages with standard deviations for the time period you select (e.g., the past 7 days or the past 30 days). Graphs can be a good way to view your blood glucose test results. The meter can display a line graph to depict blood glucose record trends, a graph showing result ranges for a standard day or a standard week, and a pie chart with different colors to illustrate the amount of test results within, above, or below your blood glucose target range.

NOTE

• You must be the only user of the meter, because the diary data will be incorrect if the meter is shared.


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Storing Test Results

The meter automatically stores up to 1,000 diary records with the time and date. You can review up to

250 diary records on the meter or up to 1,000 diary records using a computer with compatible software.

Diary records are stored from the newest to the oldest. It is very important to have the correct time and date set. Having the correct time and date setting helps ensure accurate interpretation of blood glucose test results by you and your healthcare professional.

Each diary record can contain:

• Date and time

• Blood glucose test result

• Meal time (events)

• Carbs

• Health event

• Bolus Insulin

• Basal Insulin

You can display filtered diary data in graphical or table format.

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NOTE

•

Do not change your therapy based on one individual record or test result in the diary.

• This chapter shows sample screens. The screens may look slightly different from the screens on the meter. If you have any questions about the meter screens, contact ACCU-CHEK Customer Care Service

Center at 1-800-688-4578.

• The information in the diary is saved when you replace the batteries. You need to check the time and date after you replace the batteries. For more information on changing the batteries, see Chapter 8,

Maintenance.

• Once 1,000 records are in the diary memory, adding a new record causes the oldest diary record to be deleted.

• The control results are stored in memory, but cannot be reviewed on the meter.

• Before reviewing diary records or control results with software, the stored diary records must first be downloaded to a compatible software application. For product availability, please contact ACCU-CHEK

Customer Care Service Center at 1-800-688-4578.

• Control results are not used in any report or graph.

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4.2 Viewing or Modifying Your Data

The View Data screen displays the following information:

Date of Record(s)

Time of Blood

Glucose Test

Blood Glucose Test

Icon

Meal Time Icon

Carbs Icon

Unit of Measure

Blood Glucose Test Result

Appropriate Bolus Icon

Select View

Change meter display between blood glucose, bolus, and carbs views.

Health Event Icon

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NOTE

• If data are not available, the No Data Available screen is displayed.

• The View Data screen displays the records in the order in which they occurred with the most recent record shown on top.

• For the blood glucose test result:

• “HI” is displayed if the test result is above the measurement range.

• “LO” is displayed if the test result is below the measurement range.

• The blood glucose test result is blank if a blood glucose test value does not exist.

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Icon descriptions:

Icon Icon Name

Basal Insulin bG Test

Meal Time

Carbs

Health Event

Bolus Insulin

Description

Basal insulin entered into the diary record.

Icon is displayed when information exists for this diary record regarding a blood glucose test.

Icon is displayed when information exists for this diary record regarding meal time.

Icon is displayed when information exists for this diary record regarding carbs.

Icon is displayed when information exists for this diary record regarding health events.

Bolus insulin entered into the diary record.

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You can view a diary record with its attributes (blood glucose value, meal time, carbs, health event, bolus, and basal).

Main Menu > My Data > View Data

1.

2.

j

From the Main Menu, select

My Data and press

=

.

j

Select View Data and press

=

.

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3.

Blood Glucose View: Bolus View: Carbs View:

4

j

Shown above are View Data screens that display values for blood glucose, bolus, or carbs. To choose another view, press

.

(a pop-up menu appears). Select the view you want and press

=

.

j

Press x

or z

to view other records (the screen scrolls if there are additional records).

j To view or modify a record’s details, select the record and press = .

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4.

5.

j Press < to view the previous record or press > to view the next (newer) record.

To return to the previous screen, select Back.

or

To modify a diary record, select Modify and continue to the next step.

j Select the entry field to modify and press = .

j

Make the change in the entry field and press

=

.

j

Modify other fields, as needed.

To save the changes and return to the View Detail screen, select Save.

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NOTE

• To cancel changes or return to the View Detail screen, select Cancel.

• Scroll down to select the basal entry field.

10/18/13 2:31 PM

The following fields cannot be modified with the specified condition:

Fields

Bolus

Cannot be modified if the …

Blood glucose test result was below the hypo warning limit

Meal Time

Meal Time, Carbs, Health Event,

Bolus, and Basal

Record has no blood glucose value

Record has been used for bolus advice

4

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4.3 Adding New Data

You can add data to a diary record for carbs, health, bolus, and basal. The Add Data screen displays the following information:

Time Entry Field

Date Entry Field

scroll down

Carbs Entry Field

Health Entry Field

Bolus Entry Field

Save

Appears once data has been entered to an entry field

Basal Entry Field

86

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Main Menu > My Data > Add Data

1.

2.

3.

j


My Data and press

=

.

j Select Add Data and press = .

j Select an entry field and press

=

.

j

Make addition in the entry field and press

=

.

4

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j

Make additions to other entry fields, as needed.

To save the changes and return to the My Data screen, select Save.

NOTE

• The meter initially displays the current date and the current time.

You can change the date and time when adding a diary record, although the date and time cannot be set in the future.

• Before a diary record can be saved, data must be entered (not including date and time). “Save” is not displayed above

.

until data has been entered.

• To cancel changes and return to the My Data screen, select

Cancel.

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4.4 Reporting Your Data

Time Range

Meal Times

Blood Glucose Standard

Deviation

Calculated for the time range

Number of Tests

Used to calculate the averages and standard deviations

Blood Glucose Average

Calculated for the time range

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NOTE

• If data are not available to calculate averages, the No Data Available screen is displayed.

• Standard deviation measures how much the blood glucose test results are scattered around the blood glucose average. A low standard deviation means the blood glucose test results are tightly clustered around the blood glucose average; a high standard deviation means the blood glucose test results are widely scattered around the blood glucose average.

• Calculations do not include control results, HI values, or LO values.

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Reporting Your Blood Glucose Averages

The meter displays your blood glucose averages and standard deviations for the time range you choose

(7, 14, 30, 60, or 90 days).

Main Menu > My Data > Reports > bG Averages

1.

2.

3.

4

j


My Data and press

=

.

j

Select Reports and press

=

.

j

Select bG Averages and press

=

.

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4.

The blood glucose averages are displayed.

j

To display blood glucose averages for another time range (last 7, 14, 30, 60, or

90 days), press either

<

or

> to scroll the screen until you reach the time range you need.

To return to the Reports screen, select Back.

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Reporting Your Data Trends

The meter displays your blood glucose record trends for the time range you choose (last 8 hours, 24 hours,

48 hours, or 7 days).

Main Menu > My Data > Reports > Trend

1.

2.

3.

4

j


My Data and press

=

.

j Select Reports and press = .

j Select Trend and press = .

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94

Trend Graph Screen

Time Range

Meal Time Selection

Blood Glucose Unit of

Measure

Blood Glucose Icon

Times or Days of

Month

Arrow

Indicates blood glucose data extends beyond screen

Each Blood Glucose Value

Connected with lines

Warning Limit Hypo Level

Red horizontal line

Time Change Icon

Only shown when meter time has been changed for this data

Bolus Icon

Bolus Unit of Measure

Maximum Bolus Amount Indicator

Maximum Carbs Amount Indicator

Carbs Unit of Measure

Carbs Icon

Bolus Value

Blue bar: height shown is in relation to the bolus insulin amount

Carb Value

Dark orange bar: height shown is in relation to the carbs amount

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NOTE

• If data are not available to display the trend graph, the No Data Available screen is displayed.

• Trend graphs do not include control results.

• If (time change icon) is shown at the bottom of the Trend Graph screen, the time and date of one or more data points in the trend graph may not match the time stamp in My Data because the meter clock has been changed. All times in the trend graph show the data relative to the current meter time.

For example:

1. You take a bG test and the value is stored in the meter at 9:00 am.

2. The meter time is changed ahead 1 hour.

3. The bG data on the trend graph is shown at 10:00 am.

• Trend graph data is cleared if bolus advice data is cleared.

• On the right side of the graph, the Maximum Bolus Amount Indicator is a horizontal line with the corresponding value shown above it. The purpose of this indicator is to scale the top portion of the graph for the Bolus Value blue bars. The Maximum Bolus Amount Indicator values available on the meter are 1, 5, 15,

30, and 60 U. The indicator displayed is based on the single largest bolus insulin amount delivered for the time range chosen. For example, if the largest bolus delivered during the chosen time range is 8 U, then the meter will scale the upper graph to be between 0 and 15 U.

• On the right side of the graph, the Maximum Carbs Amount Indicator is a horizontal line with the corresponding value shown below it. The purpose of this indicator is to scale the bottom portion of the graph for the Carb Value dark orange bars. The Maximum Carbs Amount Indicator values available on the meter are

30, 60, 120, 180, and 240 g, or the equivalent scale for BE, KE, or CC. The indicator displayed is based on the single largest carbs amount for the time range chosen. For example, if the largest carbs amount for the chosen time range is 86 g, then the meter will scale the lower graph to be between 0 and 120 g.

• Select Table to change the display to the Table View. The time range remains the same.

• The displayed insulin only includes bolus values.

4

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Trend Graph

1.

j

To display a trend graph for another time range (last

8 hours, 24 hours, 48 hours, or 7 days), press x

to highlight the time range selection field

(top of screen). Press either

< or > until you reach the time range you need.

2.

j

To display a trend graph for another meal time selection

(Overall, Pre Meal, Post Meal,

Bedtime, or Other), press either x

or z

to highlight the meal time selection field

(immediately below the time range which is at the top of the screen). Press either

<

or

> until you reach the meal time selection you need.

3.

j Press .

to display the Table

(proceed to the next section for more information).


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NOTE

The meter saves the current settings (time range, meal time, and graph view) when you select Back or when the meter powers off.

4

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Trend Table Screen

Time Range


Date of Records

Blood Glucose Icon with Blood Glucose

Unit of Measure

Time Change Icon

Only shown when meter time has been changed for this data

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Carbs Icon with Carbs Unit of

Measure

Bolus Icon with the Bolus Unit of Measure

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NOTE

• If data are not available to display the trend table, the No Data Available screen is displayed.

• Trend tables do not include control results.

• If (time change icon) is shown at the bottom of the Trend Table screen, the time and date of one or more data points in the trend table may not match the time stamp in My Data because the meter clock has been changed. All times in the trend table show the data relative to the current meter time.

For example:

1. You take a bG test and the value is stored in the meter at 9:00 am.

2. The meter time is changed ahead 1 hour.

3. The bG data on the trend table is shown at 10:00 am.

• Trend table data is cleared if bolus advice data is cleared.

• For a given record, if the blood glucose value, carb value, or bolus value is empty, the corresponding field is blank.

• The most recent record is displayed first.

4

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Trend Table

1.

j When there are multiple records, press x or z to view other records.

2.

j

To display a trend table for another time range (last

8 hours, 24 hours, 48 hours, or 7 days), press x

to highlight the time range selection field

(top of screen). Press either

< or > until you reach the time range you need.

3.

j

To display a trend table for another meal time selection



or z


(immediately below the time range which is at the top of the screen). Press either

<

or

> until you reach the meal time selection you need.

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4.

j

Press

.

to display the Graph

(see previous section for more information).


NOTE

The meter saves the current settings (time range, meal time, and table view) when you select Back or when the meter powers off.

4

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Reporting Your Standard Day

The meter displays (for a standard day) your blood glucose averages, number of tests, and standard deviations within predetermined time blocks for the time range you choose (last 7, 14, 30, 60, or 90 days).

Main Menu > My Data > Reports > Standard Day

1.

2.

3.

j


My Data and press

=

.

j


=

.

j

Select Standard Day and press

=

.

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Standard Day Graph Screen

Time Range



Measure


Time of Day


Red horizontal line

Arrow

Indicates blood glucose average is off the top of the graph (“X” is not displayed)

Ending Time of a Time

Block

Vertical dashed line

52123_07006322001.indb 103

Box for Each Time Block

• “X” in center of box indicates the average of all blood glucose test results for the selected criteria.

• The top of the box indicates

1 standard deviation above the average and the bottom of the box indicates 1 standard deviation below the average. The box is not displayed if there are not enough data to determine standard deviation.

• The top of box is open if the standard deviation is off the top of the graph.

• Box and “X” are not displayed for a time block if no data are found.

4

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NOTE

• If data are not available to display the standard day graph, the No Data Available screen is displayed.

• The standard day graph does not include control results, HI values, or LO values.

104

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Standard Day Graph

1.

j

To display a standard day graph for another time range

(last 7, 14, 30, 60, or 90 days), press x to highlight the time range selection field (top of screen). Press either

<

or

> until you reach the time range you need.

2.

j

To display a standard day graph for another meal time selection (Overall, Pre Meal,

Post Meal, Bedtime, or Other), press either x

or z

to highlight the meal time selection field (immediately below the time range which is at the top of the screen). Press either

<

or

>

until you reach the meal time selection you need.

3.

j

Press

.




4

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NOTE


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Standard Day Table Screen

Time Range


Time Block


Standard Deviation (SD)

Number of Tests

4

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NOTE

• If data are not available to display the standard day table, the No Data Available screen is displayed.

• Standard day table calculations do not include control results, HI values, or LO values.

• For a standard deviation to be displayed for a given time block, there must have been two or more tests recorded during the time block.

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Standard Day Table

1.

j Press x or z to scroll screen.

2.

j

To display a standard day table for another time range (last 7,

14, 30, 60, or 90 days), press x to highlight the time range selection field (top of screen).

Press either

<

or

>

until you reach the time range you need.

3.

j

To display a standard day table for another meal time selection



or z

to highlight the meal time selection field (immediately below the time range which is at the top of the screen). Press either < or > until you reach the meal time selection you need.

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4.

j

Press

.




NOTE


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Reporting Your Standard Week

The meter displays (for a standard week) your blood glucose averages, number of tests, and standard deviations for each day of the week for the time range you choose (last 7, 14, 30, 60, or 90 days).

Main Menu > My Data > Reports > Standard Week

1.

2.

3.

4

j From the Main Menu, select

My Data and press

=

.

j


=

.

j

Select Standard Week and press = .

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10/18/13 2:31 PM

Standard Week Graph Screen

Time Range



Measure


Day of Week


Red horizontal line

Arrow

Indicates blood glucose average is off the top of the graph (“X” is not displayed)

Box for Each Time Block

• “X” in center of box indicates the average of all blood glucose test results for the selected criteria.

• The top of the box indicates 1 standard deviation above the average and the bottom of the box indicates 1 standard deviation below the average. The box is not displayed if there are not enough data to determine standard deviation.

• The top of box is open if the standard deviation is off the top of the graph.

• Box and “X” are not displayed for a day if no data are found.

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NOTE

• If data are not available to display the standard week graph, the No Data Available screen is displayed.

• The standard week graph does not include control results, HI values, or LO values.

4

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Standard Week Graph

1.

j

To display a standard week graph for another time range

(last 7, 14, 30, 60, or 90 days), press x to highlight the time range selection field (top of screen). Press either

<

or


2.

j

To display a standard week graph for another meal time selection (Overall, Pre Meal,


or z


<

or

>


3.

j

Press

.




114

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NOTE


4

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Standard Week Table Screen

Time Range


Day of Week


Standard Deviation (SD)

Number of Tests

NOTE

• If data are not available to display the standard week table, the No Data Available screen is displayed.

• Standard week table calculations do not include control results, HI values, or LO values.

• For a standard deviation to be displayed for a given day of the week, there must have been two or more tests recorded during the day.

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Standard Week Table

1.

j

Press x

or z

to scroll screen.

2.

j

To display a standard week table for another time range

(last 7, 14, 30, 60, or 90 days), select the time range selection field (top of screen). Press either

<

or

>

until you reach the time range you need.

3.

j

To display a standard week graph for another meal time selection (Overall, Pre Meal,


or z


<

or

>


4

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4.

j

Press

.




NOTE


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Reporting Your Target

The meter displays a pie chart illustrating your blood glucose records as “Above,” “Within,” “Below,” and

“Hypo” for the time range you choose (last 7, 14, 30, 60, or 90 days).

Main Menu > My Data > Reports > Target

1.

2.

3.

4

j


My Data and press

=

.

j


=

.

j Select Target and press = .

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Target Graph Screen

Time Range

Legend

Blood glucose test result categories


Pie Chart

Represents the percentages for the blood glucose test result categories

NOTE

• If data are not available to display the target graph, the No Data Available screen is displayed.

• The target graph does not include control results, HI values, or LO values.

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Target Graph

1.

j

To display a target graph for another time range (last 7, 14,

30, 60, or 90 days), select the time range selection field (top of screen). Press either < or > until you reach the time range you need.

2.

j

To display a target graph for another meal time selection



or z


(immediately below the time range which is at the top of the screen). Press either < or > until you reach the meal time selection you need.

3.

j

Press

.



To return to the Reports screen, select Back .

4

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NOTE


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Target Table Screen

Time Range

Legend

Blood glucose test result categories


Percentage of Occurrence

4

NOTE

• If results or data are not available for the selected time period and meal time, the No Data Available screen is displayed.

• The target table does not include control results, HI values, or LO values.

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Target Table

1.

j

To display a target table for another time range (last 7, 14,

30, 60, or 90 days), select the time range selection field (top of screen). Press either

<

or


2.

j

To display a target table for another meal time selection


Bedtime, or Other), press either x or z to highlight the meal time selection field

(immediately below the time range which is at the top of the screen). Press either < or > until you reach the meal time selection you need.

3.

j

Press

.

to display the Target

Graph (see previous section for more information).


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NOTE


4

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4.5 Downloading Your Data to a Computer

We offer a variety of software to help you transfer your stored results to a computer to track, identify patterns, and print. For information on ACCU-CHEK software, contact the ACCU-CHEK Customer Care Service

Center at 1-800-688-4578.

1.

j Install the software according to the instructions.

j

To transfer the results to a computer, connect the infrared device to the computer according to the software instructions.

2.

j Run the software program and follow the instructions to download information. Make sure the software is ready to accept data from the meter.

3.


My Data and press

=

.

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4.

5.

Infrared (IR) Window

6.

j

Select Data Transfer and press

= .

j

Locate the infrared (IR) window on the top of the meter. j

Locate the IR window on the computer’s infrared cable.

j Point the two IR windows toward each other. They should be 1 to 4 inches apart.

j

Follow the prompts on your computer software to start the data transfer.

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10/18/13 2:31 PM

7.

j

Once the data transfer is complete, the Data Transfer

Complete screen is displayed for 3 seconds and then the meter turns off.

NOTE

If the data did not transfer successfully, turn off the meter, turn the meter back on, and try again. If you still have problems, contact

ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

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5

Changing Meter Settings

5.1 Overview

5.2 Setting bG Test Reminders: After High bG, After Low bG, After Meal

5.3 Setting Alarm Clock Reminders: bG Test, Injection, Other

5.4 Setting Date Reminders: Dr. Visit, Lab Test

5.5 Setting Bolus Advice for the First Time

5.6 Setting Time Blocks, Health Events, Advice Options: Bolus Advice Set Up

5.7 Setting Warning Limits: Hyper, Hypo

5.8 Turning Key Lock On or Off

5.9 Setting the Language

5.10 Setting Units: Carbs, Insulin Increment, Max Bolus

5.11 Setting the Beeper, Vibrate, Key Sound

5.12 Setting the Time Format, Time, Date

5.13 Setting Time Blocks: Bolus Advice Not Set Up

5.14 Backlight Settings

52123_07006322001.indb 129

5

171

174

177

180

183

191

147

156

165

168

130

131

137

142

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5.1 Overview

You have the flexibility to change the ACCU-CHEK Aviva Expert meter settings that you initially selected during the Setup Wizard process. You can make adjustments to the meter settings in order to meet changing conditions. Consult with your healthcare professional to ensure the appropriate settings are selected.

Settings: Important Information

• When editing a setting, any unsaved changes are discarded if the meter turns off or if a test strip is inserted into the meter.

• It is important to ensure that the time and date are correctly set in order to create accurate diary records.

NOTE


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5.2 Setting bG Test Reminders: After High bG, After Low bG,

After Meal

bG Test Reminders: Important Information

• At the scheduled time, the meter turns on and displays the reminder (if a test strip has not been inserted).

However, if the meter is already on when the reminder is scheduled and no blood glucose test was performed, the reminder is displayed when the meter powers down.

• Dismiss the reminder by pressing

.

.

• Reschedule (snooze) the reminder by pressing , . The snooze time for After High bG is 15 minutes.

The snooze time for After Low bG and After Meal is 5 minutes.

• If not dismissed or snoozed, the reminder is displayed a total of four times at intervals of 2 minutes, after which the meter dismisses the reminder.

• When you perform a blood glucose test, the meter dismisses any bG test reminders which are pending within the next 30 minutes. If necessary, a new reminder is scheduled based upon the blood glucose test result.


5

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Main Menu > Settings > Reminders > bG Test Reminders

1.

2.

3.

j


Settings and press

=

.

j

Select Reminders and press

=

.

j

Select bG Test Reminders and press

=

.

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4.

j

Select either After High bG,

After Low bG, or After Meal and press

=

.

j Proceed to either After High bG, After Low bG, or After Meal in this step.

To Turn the After High bG

Reminder On or Off: j

Select the Reminder entry field and press = . j Select On or Off and press = .

To Change the bG Threshold: j Select the bG Threshold entry field and press = .

j

Set the bG Threshold level and press

=

.

To Change the Remind After

Time: j Select the Remind After entry field and press

=

. j

Set the amount of time after a high blood glucose test result you want to be reminded to retest your blood glucose and press

=

.

To save the changes and return to the bG Test

Reminders screen, select

Save.

5

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134

To Turn the After Low bG

Reminder On or Off: j

Select the Reminder entry field and press

=

. j Select On or Off and press = .

To Change the bG Threshold: j Select the bG Threshold entry field and press = .

j

Set the bG Threshold level and press

=

.


Time: j

Select the Remind After entry field and press = .

j Set the amount of time after a low blood glucose test result you want to be reminded to retest your blood glucose and press = .

To save the changes and return to the bG Test

Reminders screen, select

Save.

To Turn the After Meal

Reminder On or Off:

j


To Change the Snack Size:

j Select the Snack Size entry field and press

=

.

j

Set the Snack Size amount and press

=

.


Time:

j

Select the Remind After entry field and press = .

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5

j

Set the amount of time after a meal (carb entry larger than the snack size) you want to be reminded to retest your blood glucose and press = .

To save the changes, select

Save.

If you did not change the Snack

Size, the meter returns to the bG

Test Reminders screen.

If you changed the Snack

Size, the After Meal screen is displayed.

j Select OK to return to the bG

Test Reminders screen.

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NOTE

• Remind After is displayed as “HH:MM” (e.g., 1:30) where “H” is hour and “M” is minute.

• When the meter is displaying the Remind After Meal screen for the first time, if bolus advice has not been set up, the default for Snack Size is no entry (“---g”). If bolus advice has been set up, the default value is the value set for the Snack Size on the Advice Options screen.

• To cancel changes or to return to the previous screen, select Cancel.

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5.3 Setting Alarm Clock Reminders: bG Test, Injection, Other

Alarm clock reminders are a helpful way to remind you to test your blood glucose, or for any other daily appointment. You can set up to eight reminders per day.

Alarm Clock Reminders: Important Information


However, if the meter is already on when the reminder is scheduled (and no blood glucose test was performed for an Alarm Clock bG Test Reminder, or no basal insulin data was entered for an Alarm Clock

Injection Reminder), the reminder is displayed when the meter powers down.


.

. Reschedule (snooze) the reminder for 15 minutes by pressing , .

• Alarm Clock Injection Reminder: Dismiss the reminder by entering basal insulin data.

• If not dismissed or snoozed, the reminder is displayed a total of four times at intervals of 2 minutes, after which the meter dismisses the reminder.

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• When you perform a blood glucose test, the meter dismisses Alarm Clock bG Test reminders which are pending within the next 30 minutes.

• When you enter basal insulin data, the meter dismisses Alarm Clock Injection Reminders which are pending within the next 30 minutes.


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Main Menu > Settings > Reminders > Alarm Clock

1.

2.

3.

j


Settings and press = .

j

Select Reminders and press

= .

j Select Alarm Clock and press

= .

5

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139

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4.

To Turn On or Change a

Reminder:

j

Select the time entry field for a

Reminder and press = .

j Set the time to schedule the

Reminder and press

=

.

j

Press

=

. Select the type of Reminder (i.e., bG Test,

Injection or Other) and press

= .

j

Repeat the above steps to set additional reminders.

To Turn Off a Reminder:

j Select the type of Reminder entry field (i.e., bG Test,

Injection or Other) and press

=

.

j Select Off and press = .

j Repeat the above steps to turn off additional reminders.

To save the changes and return to the Reminders screen, select Save.

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NOTE

• To cancel changes or return to the Reminders screen, select Cancel.

• Time for the Alarm Clock reminders can be set in 15-minute increments, where “HH” is hour, “MM” is minutes, and with “am” or “pm” for the 12-hour format.

• If you tested within 30 minutes of a bG Test Reminder, the reminder does not occur.

• If you entered basal insulin data within 30 minutes of an Injection reminder, the reminder does not occur.

• Exposure to extreme cold conditions may disable Alarm Clock reminders until the meter is turned on.

5

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5.4 Setting Date Reminders: Dr. Visit, Lab Test

Date reminders are a helpful way to remind you of an upcoming Dr. visit or lab test.

Date Reminders: Important Information

• Displayed when you turn on the meter and a test strip has not been inserted.

• Dismiss the reminder either by pressing .

or by inserting a test strip.


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Main Menu > Settings > Reminders > Date Reminders

1.

2.

3.


Settings and press

=

.

j Select Reminders and press

=

.

j

Select Date Reminders and press

=

.

5

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4.

j

Select either Dr. Visit or Lab

Test and press

=

.

j

Proceed to either Dr. Visit or

Lab Test in this step.

To Turn the Dr. Visit Reminder

On or Off:

j


To Set the Date:

j

Select the Date entry field and press

=

. j Set the Day and press = . j Set the Month and press = . j

Set the Year and press

=

.

To Set the Time (Optional):

j

Select the Time entry field and press

=

.

j

Set the Time and press

=

.

To save the changes and return to the Date Reminders screen, select Save.

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5

To Turn the Lab Test

Reminder On or Off:

j


To Set the Date:

j Select the Date entry field and press = . j

Set the Day and press

=

. j

Set the Month and press

=

. j

Set the Year and press

=

.

To Set the Time (Optional):

j


=

.

j Set the Time and press = .

To save the changes and return to the Date Reminders

screen, select Save.

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NOTE

• Setting a time for a Date Reminder is optional. If you choose not to set a time, ensure the Time entry field value is “--:--” (no entry).

• To cancel changes or to return to the Date Reminders screen, select Cancel.

• Time for the Dr. Visit Reminder and the Lab Test Reminder can be set in 15-minute increments, where

“HH” is hour, “MM” is minutes, and with “am” or “pm” for the 12-hour format.

• Date Reminders do not automatically turn on the meter and display the Reminder. Date Reminders only occur when you power on the meter on the appropriate date.

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5.5 Setting Bolus Advice for the First Time

Set Up Bolus Advice

If you did not set up bolus advice when you went through the Setup Wizard and have now decided to utilize bolus advice, proceed with this section. Once you do set up bolus advice, you cannot turn it off.

It is suggested that you review the information in the Getting Started Guide before continuing. Prior to setting up time blocks for bolus advice, it is recommended that you decide how many time blocks you need and also determine the start/end times. Talk to your healthcare professional about arranging your time blocks to help best manage your diabetes. For each time block, you can set up different blood glucose target ranges, carb ratios, and insulin sensitivities to accommodate your differing insulin needs throughout the day.

WARNING

• Bolus advice should be used only if you are using U100, rapid-acting insulin for bolus dosing.

• Do not use bolus advice with Neutral Protamine Hagedorn (NPH) or any other intermediate-acting insulin.

• Do not use bolus advice if basal insulin dose is unstable.

• Long-acting insulin should not be used as a meal bolus or as a correction bolus.

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Time Blocks–Bolus Advice Screen

Time Block Start Time

Target Range Lower

Limit Value

Carb Ratio–Number of

Insulin Units

scroll down

Insulin Sensitivity–

Number of Insulin Units

Time Block End Time

Target Range Upper Limit Value

Carb Ratio–Number of Carbs

Scroll Bar

Insulin Sensitivity–Change in

Glucose Level

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Main Menu > Settings > Bolus Advice

1.

2.

3.

5

j


Settings and press

=

.

j

Select Bolus Advice and press

=

.

j If you do NOT want to set up bolus advice, select No to return to the Settings screen. j

To set up bolus advice, select

Yes and continue to the next step.

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4.

5.

150

j

To continue, select Next.

To Change Time Blocks:

j

Select a time block to edit and press

=

.

scroll down

52123_07006322001.indb 150

To Change the End Time:

j

Select the End Time entry field and press

=

.

j Set the End Time and press

= .

10/18/13 2:31 PM

To Change the Target Range:

j

Select the entry field for the lower value of the Target

Range and press = .

j Set the value and press = .

j

Select the entry field for the upper value of the Target

Range and press

=

.


To Change the Carb Ratio:

j

Select the entry field for the number of Insulin Units and press = .

j

Set the number of Insulin Units and press

=

.

j

Select the entry field for the amount of Carbs and press

= .

j

Set the amount of Carbs covered by the number of

Insulin Units and press

=

.

6.

To Change the Insulin

Sensitivity:

j

Select the entry field for the number of Insulin Units and press = .

j


=

.

j

Select the entry field for the

Insulin Sensitivity level and press = .

j

Set the Insulin Sensitivity level and press

=

.

j

Select Save.

The carb ratio and insulin sensitivity are copied to all time blocks. You may edit the target range, carb ratio, and insulin sensitivity for any other time block, if necessary.

j

Select OK.

5

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7.

j

Return to Step 5 to change another Time Block.

j

Continue in order to add or remove Time Blocks, otherwise select Next and proceed to Step 8.

To Add a Time Block:

j Select the last time block and press

=

.

j


=

.

j

Set the End Time of the selected time block and press

= . This will be the start time of the added time block.

j

To save the changes and return to the Time Blocks screen, select Save.

j Add another Time Block, or proceed to Step 8.

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To Remove a Time Block:

j

Select the Time Block you want to remove and press

=

.

10/18/13 2:31 PM

5

8.

9.

j


=

.

j

Set the End Time to match the start time of the Time Block and press = . j


j Remove another Time Block, or proceed to Step 8.

To Change the Health Events:

j

Select the entry field of the

Health Event to be changed and press = .

j Set the percentage and press

=

.

j

Repeat the previous steps to change another Health Event.

j To continue, select Next.

To Change the Meal Rise:

j

Select the Meal Rise entry field and press

=

. j Set the Meal Rise limit and press = .


j Select the Snack Size entry field and press = .

j


=

.

To Change the Acting Time:

j

Select the Acting Time entry field and press

=

.

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10.

j

Set the Acting Time duration and press

=

.

To Change the Offset Time:

j

Select the Offset Time entry field and press

=

. j

Set the Offset Time duration and press = .

To save the changes and exit,

select Save. j

Select OK.

11.

j

To return to the Settings screen, select Back.

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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, or “allowed,” within a certain range, even though a meal bolus has been delivered. Enter the maximum increase in your blood glucose test result that is to be tolerated without an additional correction bolus.

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. In this case (in contrast to regular meals), an increase in your blood glucose test result is not tolerated since the meal rise factor is not triggered for bolus advice calculations.

Acting Time

The acting time is 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 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.

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5.6 Setting Time Blocks, Health Events, Advice Options: Bolus

Advice Set Up

If bolus advice has been set up, use this section for:

• Adding or removing time blocks

• Changing the time of day when time blocks occur

• Changing the values for target range, carb ratio, and insulin sensitivity for any time block

• Changing health event percentages

• Changing advice options (meal rise, snack size, acting time, offset time)

Before continuing, it is recommended that you review the Getting Started Guide, determine how many time blocks you need, and determine the start/end times for each time block. To help best manage your diabetes, talk to your healthcare professional about arranging your time blocks, including setting up different blood glucose target ranges, carb ratios, and insulin sensitivities for each time block.

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Setting Time Blocks–Bolus Advice is Set Up

Main Menu > Settings > Bolus Advice > Time Blocks

1.

2.

3.



j Select Bolus Advice and press

= .

j

Select Time Blocks and press

=

.

5

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4.

To Add a Time Block:

j Select the last time block and press

=

.

j Proceed to

To Change the

Time Blocks.

To Remove a Time Block:

j Select the Time Block you want to remove and press

=

.

To Add or Remove Time

Blocks:

If you do not need to add or remove time blocks, then proceed to

To Change the Time

Blocks.

j


=

.

j

Set the End Time of the selected Time Block and press

= . This will be the start time of the added time block.

j


j

Select the End Time entry field and press = .

j Set the End Time to match the start time of the Time Block and press

=

.

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j To save the changes and return to the Time Blocks screen. Select Save.

j

Proceed to

To Change the

Time Blocks.

To Change the Time Blocks:

j

Select a Time Block to edit and press

=

.

5.


j


=

. j Set the End Time and press

= .


j Select the entry field for the lower value of the Target

Range and press

=

.

j

Set the value and press

=

.

j


Range and press = .

j

Set the value and press

=

.

To Change the Carb Ratio:

j Select the entry field for the number of Insulin Units and press

=

.

j


=

.

j Select the entry field for the amount of Carbs and press

=

.

j

Set the amount of Carbs covered by the selected units of insulin and press = .


Sensitivity:

j Select the entry field for the number of Insulin Units and press

=

.

j

Set the number of Insulin Units and press = .

j Select the entry field for the

Insulin Sensitivity level and press

=

.

5

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j

Set the Insulin Sensitivity level and press

=

.

j

Select Save.

6.

j

To change another time block, select the time block and press

=

. Return to Step 5.

j To return to the Bolus Advice screen, select Back.

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Setting Health Events–Bolus Advice is Set Up

Main Menu > Settings > Bolus Advice > Health Events

1.

2.

3.

j


Settings and press

=

.

j


=

.

j

Select Health Events and press

=

.

5

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161

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4.

To Change the Health Events:

j

Select the entry field of the

Health Event to be changed and press = .

j Set the percentage and press

=

.

j

Repeat the previous steps to change other Health Events.

To save the changes and return to the Bolus Advice screen, select Save.

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Setting Bolus Advice Options–Bolus Advice is Set Up

Main Menu > Settings > Bolus Advice > Advice Options

1.

2.

3.

j


Settings and press

=

.

j


=

.

j

Select Advice Options and press

=

.

5

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4.

To Change the Meal Rise:

j

Select the Meal Rise entry field and press

=

.

j Set the Meal Rise limit and press = .


j Select the Snack Size entry field and press

=

.

j


=

.

To Change the Acting Time:

j

Select Acting Time entry field and press = .

j Set the Acting Time duration and press

=

.

To Change the Offset Time:

j Select the Offset Time entry field and press

=

.

j

Set the Offset Time duration and press

=

.

To save the changes, select

Save.

If you did not change the Snack

Size, the meter returns to the

Bolus Advice screen.

If you changed the Snack Size, the meter displays the Advice

Options screen.

j Select OK to return to the

Bolus Advice screen.

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5.7 Setting Warning Limits: Hyper, Hypo

You can set blood glucose warning limits for hyperglycemia (Hyper) or hypoglycemia (Hypo) conditions.

Once these blood glucose limit values have been set, if your test result is above the hyper warning limit, the meter displays the Above Hyper Warning Limit message: “Consider checking for ketones, bG and insulin regularly.” If your test result is below the hypo warning limit, the meter displays the Below Hypo Warning

Limit message: “Eat fast carbs of at least (number of carbs)¹ Retest bG.”

1

The meter displays a recommended amount of fast carbohydrates.

WARNING

This function is no substitute for hyperglycemia or hypoglycemia training by your healthcare professional.

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Main Menu > Settings > Meter > Warning Limits

1.

2.

3.

j


Settings and press

=

.

j

Select Meter and press

=

.

j Select Warning Limits and press

=

.

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5

4.

To Change the Hyper Blood

Glucose Level:

j

Select the Hyper entry field and press = .

j Set the Hyper (upper) blood glucose level and press

=

.

To Change the Hypo Blood

Glucose Level:

j

Select the Hypo entry field and press

=

.

j

Set the Hypo (lower) blood glucose level and press = .

To save the changes and return to the Meter Menu screen, select Save.

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5.8 Turning Key Lock On or Off

The key lock feature allows you to lock all of the buttons on the meter, except for the power on/off button.

This serves as a safety measure against unintentional activation of meter functions.

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Main Menu > Settings > Meter > Key Lock

1.

2.

3.

j


Settings and press

=

.

j


=

.

j Select Key Lock and press = .

5

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4.

j

Press

=

to display the Key

Lock pop-up menu.

j

Select On or Off.

To save the change and return to the Meter Menu screen, select Save.

If the buttons are locked when you turn on the meter, the Key

Lock screen is displayed.

j To unlock the buttons, press and hold , and .

at the same time until the Main Menu is displayed.

The buttons remain unlocked for the current session. When the meter is turned on again, the buttons are locked.

Key Lock: Important

Information

j

When the buttons are locked, you can still turn the meter on and off. You can also adjust the backlight.

j

The buttons are unlocked when a test strip is inserted into the meter.

For these occurrences, the buttons remain unlocked for the current session. When the meter is turned on again, the buttons are locked.

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5.9 Setting the Language

You can select a language from the predefined list.

5

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Main Menu > Settings > Meter > Language

1.

2.

3.

j


Settings and press

=

.

j


=

.

j Select Language and press

=

.

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5

4.

j

Press

=

to display the

Language options.

j

Select the desired Language and press = .


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5.10 Setting Units: Carbs, Insulin Increment, Max Bolus

You can set up the meter for different carbohydrate (carbs) units (Grams, BE, KE, or CC).

The insulin increment can be set to either 0.5 or 1U. You can set the max bolus for any whole number between 0 and 50. Once the Carbs Units are set and the bolus advice is activated, the Carbs Units cannot be changed.

NOTE

You should ask the advice of your healthcare provider (HCP) for delivering large doses of insulin.

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Main Menu > Settings > Meter > Units

1.

2.

3.

j


Settings and press

=

.

j


=

.

j Select Units and press = .

5

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10/18/13 2:32 PM

4.

To Change the Max Bolus:

j

Select the Max Bolus entry field and press

=

.

j Set the Max Bolus level and press = .


j

Press

=

to display the list of units for carbs.

j

Select the units (Grams, BE,

KE, or CC) and press = .


Increment :

j Select the Insulin Increment entry field and press = .

j

Select 0.5 U or 1 U Insulin

Increment and press

=

.

NOTE

Once this is set and bolus advice is activated, this unit cannot be changed. If this unit needs to be changed, contact the ACCU-CHEK Customer

Care Service Center at

1-800-688-4578.

NOTE

For more information on the units for carbohydrates and carbohydrate equivalents, see

Appendix B, Carb Units.

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5.11 Setting the Beeper, Vibrate, Key Sound

You can set up the meter for sound mode and/or vibrate mode. The meter features different sound (beeper) tones. Sounds may occur for:

• Button presses

• Errors

• Warnings

• Reminders

NOTE

• Beeper and vibrate cannot both be turned off at the same time.

• When Key Sound is on, the meter beeps each time a button is pressed.

• Even when the beeper is turned off, the meter still beeps when an error message occurs.

• When in the low battery condition, the meter uses the medium beeper level (if the beeper level is set to high) and disables vibrate. In the low battery condition, the main menu screen will continue to display the icons for vibrate and beeper, unless you have set them to Off. After the batteries are replaced with new ones, the meter returns to the beeper/vibrate settings you have set.

5

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Main Menu > Settings > Sound/Vibrate

1.

2.

3.

j


Settings and press

=

.

j

Select Sound/Vibrate and press

=

.

To Change the Beeper Sound

Level:

j

Select the Beeper entry field and press

=

.

j Select the Beeper sound level

(Off, Low, Medium, or High) and press

=

.

To Turn the Vibrate On or Off:

j

Select the Vibrate entry field and press

=

.

j

Select the Vibrate mode (On or

Off) and press = .

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5

To Change the Key Sound:

j

Select the Key Sound entry field and press

=

.

j Select the Key Sound mode

(On or Off) and press = .

To save the changes and return to the Settings Menu screen, select Save.

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5.12 Setting the Time Format, Time, Date

NOTE

• Changing the date and time will impact the Trend Graph and the Trend Table (see Reporting Your

Data Trends in Section 4.4, Reporting Your Data).

• For 12-hour time format, time is displayed as “HH:MM A/P” (example: 3:53 pm) and for 24-hour time format, time is displayed as “HH:MM” (example: 15:53) where “H” is hour and “M” is minute.

• The date format is displayed as “DD MMM YY” (example: 02 Feb 08) where “D” is day, “M” is month, and “Y” is year.

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Main Menu > Settings > Time/Date

1.

2.

3.

j


Settings and press

=

.

j Select Time/Date and press

=

.

To Change the Time Format:

j Select the Time Format entry field and press

=

.

j

Select 12-hr or 24-hr Time

Format and press

=

.

5

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To Change the Time:

j


=

.

j Set the Hour and press = .

j Set the Minutes and press = .

j

If Time Format is 12 hr, select am or pm and press

=

.

To Change the Date:

j

Select the Date entry field and press

=

.

j

Set the Day and press

=

.

j Set the Month and press = .

j Set the Year and press = .

To save the changes and return to the Settings Menu screen, select Save.

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5.13 Setting Time Blocks: Bolus Advice Not Set Up

This section is for changing, adding, and removing time blocks only if bolus advice has not been set up.

For each time block, you can set up different blood glucose target ranges. It is suggested that you review the Getting Started Guide before continuing. Prior to setting up time blocks, it is recommended that you determine how many time blocks you need and also determine the start/end times. Talk to your healthcare professional about arranging your time blocks in order to help best manage your diabetes.

Target Range Lower Value Time Block End Time

Target Range Upper Value

5

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Change End Time, Target Range Lower Value, and/or Target Range Upper Value

Main Menu > Settings > Time Blocks

1.

2.

3.



Time Blocks does not appear if bolus advice has been set up.

j Select Time Blocks and press

=

.

j

Select the Time Block to edit and press

=

.

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4.


j


=

.

j Set the End Time and press

= .


j

Select the entry field for the lower value of the Target

Range and press = .


j


Range and press

=

.


To save the changes and return to the Time Blocks screen, select Save.

5.

j Repeat Steps 3 and 4 to change another time block.

Otherwise, select Back to return to the Settings screen.

5

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NOTE

• When you set the end time, the meter sets this end time as the start time for the next time block.

• The end time can be set in 30-minute increments.

• To cancel changes press , .

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Add a Time Block


1.

2.

3.

j


Settings and press

=

.



= .

j Select the last Time Block and press

=

.

5

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10/18/13 2:32 PM

4.

j


=

.

j

Set the End Time of the selected Time Block and press

=

. This will be the start time of the added time block.


5.

j

Update the End Times and

Target Ranges for all time blocks, as needed. See

Change End Time, Target

Range Lower Value, and/or

Target Range Upper Value in this section.

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Remove a Time Block


1.

2.

3.

j


Settings and press

=

.



= .

j

Select the Time Block you want to remove and press

=

.

5

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4.

j


=

.

j

Set the End Time to match the start time of the Time Block and press = .


5.

j

Update the End Times and Target Ranges for the remaining time blocks, as needed. See

Change End

Time, Target Range Lower

Value, and/or Target Range

Upper Value in this section.

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5.14 Backlight Settings

The backlight on your ACCU-CHEK Aviva Expert meter helps you read the information on the meter display under different lighting conditions. You can adjust the backlight level by pressing the backlight button on the front of the meter. The backlight adjusts from low, to medium, to high, and back to low again.

5

52123_07006322001.indb 191

Backlight Button

Press to adjust the backlight level.

191

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NOTE

• When the meter is turned on, the backlight is set to medium.

• When the backlight is set to high or medium and no button activity has occurred for approximately

15 seconds, the meter goes to low backlight (to conserve battery life). The meter restores the original backlight setting when you press a button, insert a test strip, or when the meter displays the bG Results screen.

• When in the low battery condition, the meter uses the medium backlight level (if the backlight level is set to high). After the batteries are replaced with new ones, the meter again allows the high backlight setting.

• The backlight button is disabled during a blood glucose test, a control test, and when the meter is transferring data.

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6

Icons, Reminders, Warnings, and Errors

6.1 Overview

6.2 List of Icons

6.3 Confirming a Reminder, Warning, or Error

6.4 List of Reminders

6.5 List of Warnings

6.6 List of Errors

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208

213

6

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6.1 Overview

This chapter provides you with detailed listings of all the icons, reminders, warnings, and errors included in the meter.

NOTE


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6.2 List of Icons

The icons and icon names in the meter are:

Icon Name

Add Data

Icon

Analyzing

Basal Insulin

Beeper

Blood Glucose Averages

Blood Glucose Test

Bolus Advice

Bolus Advice (Settings)

Bolus Insulin

Carbs

Icon Name

Control Test

Date

Download (Data Transfer)

Error

Health

Low Battery

Meal Time

Meter

Meter (Settings)

My Data

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Icon

6

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Icon Name

Reminder

Reminders (Settings)

Reports

Settings

Sound/Vibrate (Settings)

Time

Icon Icon Name

Time Block (Settings)

Time Change

Time/Date (Settings)

Vibrate

View Data

Warning

Icon

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6.3 Confirming a Reminder, Warning, or Error

To confirm (or dismiss) most reminders or warnings, press

.

. Some error messages require a different confirmation, such as “Retest with new Strip” or “Replace batteries now.” To place some reminders in the snooze mode, press

,

. See the following sections for more details on a specific reminder, warning, or error.

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6.4 List of Reminders

Reminder Screen Example

Reminder Icon

Snooze

Reschedule the reminder.

This is not available for all reminders.

Reminder Title

Reminder Message

Dismiss

NOTE

• The meter beeps when it displays any reminder if the beeper setting is on.

• The meter vibrates when it displays any of the following reminders if the vibrate setting is on: After

Meal Retest, bG Test, High bG Retest, Injection, Low bG Retest, and Other.

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For instructions on how to set up meter reminders, see Chapter 5, Changing Meter Settings. The reminders available on the meter are:

Reminder Title Reminder Message

After Meal Retest Carbs entry higher than Snack

Size setting. Retest.

Basal Injection bG Test

Dr. Visit Today

It is time for your scheduled basal injection

It is time for your scheduled bG test

If the Dr. Visit time has been set:

You have a Dr. Appointment today at (Settings Dr. Visit Time)

1

Or, if the Dr. Visit time has not been set:

You have a Dr. Appointment today

Left Soft Key Right Soft Key Snooze Time

Snooze Dismiss 5 minutes

Snooze

Snooze

Dismiss

Dismiss

Dismiss

15 minutes

15 minutes

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Dr. Visit Tomorrow

If the Dr. Visit time has been set:

You have a Dr. Appointment tomorrow at (Settings Dr. Visit

Time)¹

Or, if the Dr. Visit time has not been set:

You have a Dr. Appointment tomorrow

High bG Retest

Lab Test Today

High bG Result on last test.

Retest.

If the lab test time has been set:

You have a Lab Test today at

(Settings Lab Test Time)

1

Or, if the lab test time has not been set:

You have a Lab Test today


Dismiss

Snooze Dismiss

Dismiss

15 minutes

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Lab Test Tomorrow

If the lab test time has been set:

You have a Lab Test tomorrow at

(Settings Lab Test Time)

1

Or, if the lab test time has not been set:

You have a Lab Test tomorrow


Dismiss

Low bG Retest

Other

Low bG Result on last test.

Retest.

Snooze

It is time for your Other activity Snooze

Dismiss

Dismiss

5 minutes

15 minutes

1

If set, the time of the Dr. Visit or the Lab Test is displayed on the screen.

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Reminders: Important Information

• When two or more event reminders occur at the same time, the meter displays the event reminder with the highest priority first:

1. bG Test Reminders (After High bG, After Low bG, and After Meal)

2. Alarm Clock Reminders (bG Test, Injection and Other)

3. Date Reminders (Dr. Visit and Lab Test)

The following occur when the particular reminder is enabled and scheduled:

Dr. Visit Today, Dr. Visit Tomorrow, Lab Test Today, and Lab Test Tomorrow Reminders

• Displayed when you turn on the meter and a test strip has not been inserted.

• Dismiss the reminder either by pressing

.


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Low bG Retest Reminder

• When your blood glucose test result is less than the low blood glucose threshold setting you have set up

(see Chapter 5, Changing Meter Settings), then the meter schedules a Low bG Retest reminder for the time duration you have set up. The meter maintains the duration of this scheduled reminder regardless of meter time and date changes.


• If the meter is already on when the reminder is scheduled and no blood glucose test was performed, the reminder is displayed when the meter powers down.

• When the meter displays the reminder and you do not press any meter buttons within 30 seconds, the meter turns off and displays the reminder again in 2 minutes. After the fourth time the meter displays the reminder, then the meter dismisses the reminder.


.

.

• Snooze the reminder for 5 minutes either by pressing , or by inserting a test strip.

• When you perform a blood glucose test, the meter dismisses any Low bG Retest reminders pending within the next 30 minutes. If necessary, a new reminder is scheduled based upon the blood glucose test result.

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High bG Retest Reminder

• When your blood glucose test result is greater than the high blood glucose threshold setting you have set up (see Chapter 5, Changing Meter Settings), then the meter schedules a High bG Retest reminder for the time duration you have set up. The meter maintains the duration of this scheduled reminder regardless of meter time and date changes.





.

.


• When you perform a blood glucose test, the meter dismisses any High bG Retest reminders pending within the next 30 minutes. If necessary, a new reminder is scheduled based upon the blood glucose test result.

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After Meal Reminder

• When you enter carbohydrates into the diary through one of the following screens and the carbohydrates entered are greater than the Snack Size setting, then the meter schedules an After Meal reminder for the time duration you have set up (see Chapter 5, Changing Meter Settings). The meter maintains the duration of this scheduled reminder regardless of meter time and date changes.

• Add Data screen (see Chapter 4, Managing Your Data)

• Modify Data screen (see Chapter 4, Managing Your Data)

• Detailed bG Result screen (see Chapter 2, Testing Your Blood Glucose)

• Bolus Advice screen (see the Advanced Owner’s Booklet)





.

.


• When you perform a blood glucose test, the meter dismisses any After Meal reminders pending within the next 30 minutes. If necessary, a new reminder is scheduled based upon the blood glucose test result.

6

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Alarm Clock Reminders for bG Test, Injection and Other


• When the meter displays an Alarm Clock reminder and you do not press any meter buttons, after 30 seconds the meter turns off and displays the reminder again in 2 minutes. After the fourth time the meter displays the reminder, then the meter dismisses the reminder.

• bG Test Alarm Clock Reminder


• Dismiss all active bG Test reminders by pressing .

.

• Snooze the reminder for 15 minutes either by pressing

,


• When you perform a blood glucose test, the meter dismisses any bG Test reminders that have been snoozed or that are pending within the next 30 minutes.

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• Injection Alarm Clock Reminder

• If the meter is already on when the reminder is scheduled and no basal insulin data was entered, the reminder is displayed when the meter powers down.

• Dismiss all active Injection reminders by pressing

.

.

• Snooze the reminder for 15 minutes either by pressing

,


• When you enter basal insulin data, the meter dismisses any Injection reminders that have been snoozed or that are pending within the next 30 minutes.

• Other Alarm Clock Reminder

• If the meter is already on when the reminder is scheduled, the reminder is displayed when the meter powers down.

• Dismiss this reminder either by pressing .


• Snooze the reminder for 15 minutes by pressing

,

.

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6.5 List of Warnings

Warning Screen Example

Warning Icon

No

Only shown on a few warning screens

NOTE

The meter beeps when it displays a warning if the beeper setting is on.

Warning Title

Warning Message

Yes or OK

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The warnings the meter may display are:

Warning Title

Above Hyper Warning

Limit

Warning Message

Consider checking for ketones, bG and insulin regularly

Beep/Vibrate Off Beep and Vibrate settings cannot both be turned off at same time

Below Hypo Warning Limit Eat fast carbs of at least (number of carbs)

1

Retest bG bG Test Missed Perform bG test as soon as possible

Left Soft Key Right Soft Key

OK

OK

OK

OK

Bolus Advice Not Setup Advice not provided unless setup through

Bolus Advice in Settings

Bolus Advice Timeout Bolus Advice no longer possible for this bG result

Bolus Too High Bolus above allowed amount. Bolus set to maximum.

OK

OK

OK

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Warning Title

Bolus Too Low

Warning Message

Bolus below allowed amount. Bolus set to minimum.

Calculation Out of Range No Bolus Advice available

Carbohydrate Ratio Carb Ratio seems unusual. Check entries.


OK

OK

OK

Code Key Missing

Corrupt Language

Diary Entry Used For

Advice

Diary Results Expired

Turn off Meter and insert valid Code Key

Choose another language

Diary entry used for Advice, modifications not allowed

New data cannot be saved with this record

OK

OK

OK

OK

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Warning Title

HI bG Warning

Warning Message

Consider checking bG, ketones and insulin


OK

Insulin Sensitivity

Invalid Bolus Advice

Times

Invalid Date

Insulin Sensitivity seems unusual. Check entries.

Acting time must be greater than or equal to offset time

Reenter valid date

Invalid Hyper Values

Invalid Hypo Values

Hyper value must be greater than Time

Block target ranges

Hypo value must be less than Time Block target ranges

Invalid Record Time/Date Record time/date must be older than the current meter time/date

OK

OK

OK

OK

OK

OK

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Warning Title

Invalid Target Range

Invalid Target Range

LO bG Warning

Meter Battery Low

No bG with Bolus

Test Strips Expiring

Warning Message

Lower target range value above upper target range value

Range selected conflicts with Hyper and/or

Hypo Warning Limit settings

Retest bG. Contact your doctor.


OK

OK

OK

Replace soon.

Consider testing bG before delivering

Insulin. Continue?

Change Code Key and Strips soon

No

OK

Yes

OK

1 The meter displays a recommended amount of fast carbohydrates.

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6.6 List of Errors

Error Screen Example

Error Icon

Menu

This option is not available for all errors.

Error Title

Error Message

NOTE

The meter beeps when it displays an error, even if the beeper setting is turned off.

6

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The errors the meter may display are:

Error Title

E-51

Bad Strip Error

E-52

Code Key Error

E-53

Bad Test Error

E-54

Not Enough Sample

E-55

Code Key Expired

E-56

Sample Applied Early

E-57

Electronic Error

E-58

Temp. Error

Error Message

Reinsert or replace with new Strip

Turn Meter off, reinsert or replace Code Key

Retest with new Strip


Turn Meter off, replace Code Key and Strips


Remove batteries, wait 20 seconds, replace batteries

Move Meter to correct temperature and wait 5 minutes


Menu

1

Menu

1

Menu

3

OK

2

OK

2

OK

3

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Error Title

E-59

Battery Empty

E-60

Time/Date Error

Error Message

Replace batteries now

Correct time/date if necessary


Menu

1

“Menu” is only displayed when the meter is in a bG test screen.

2

“OK” is only displayed after the splash screen (ACCU-CHEK logo screen).

3

If the meter is powering up, then “OK” is displayed above the right soft key and “Menu” is not displayed above the left soft key.

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7

Cleaning and Disinfecting the Meter and

Lancing Device

7.1 Overview

7.2 Cleaning and Disinfecting the Meter

7.3 Cleaning and Disinfecting the Lancing Device

218

220

225

7

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7.1 Overview

WARNING

• During normal testing any blood glucose meter or lancing device may come in contact with blood.

All parts of the kit are considered biohazardous and can potentially transmit infectious diseases from bloodborne pathogens, even after you have performed cleaning and disinfection.

1,2

• Cleaning and disinfecting the meter and lancing device destroys most, but not necessarily all, bloodborne pathogens.

3

• The meter and lancing device should never be used by more than one person. Do not share the meter and lancing device with anyone, including family members, due to the risk of infection from bloodborne pathogens.

1,2

• If the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.

• It is important to keep the meter and lancing device clean and disinfected.

• Wash hands thoroughly before and after handling the meter, lancing device, or test strips.

1,2,3,

See Appendix E

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What is the difference between cleaning and disinfecting?

Cleaning is the removal of dirt from the meter or lancing device.

3

Disinfecting is the removal of most, but not all, disease-causing and other types of microorganisms

(bloodborne pathogens) from the meter or lancing device.

3

3 See Appendix E

When should the meter and lancing device be cleaned and disinfected?

Clean and disinfect the meter and lancing device:

• Once per week

• When blood gets on the meter or lancing device

• Before allowing anyone else to handle the meter or lancing device

NOTE

For technical assistance or questions on cleaning and disinfecting, please contact the ACCU-CHEK


7

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7.2 Cleaning and Disinfecting the Meter

To clean and disinfect without damaging the meter, follow these procedures carefully.

When to Clean and Disinfect the Meter

• Clean the meter prior to disinfecting.

• Clean and disinfect the meter at least once per week, or when blood is present on the surface of the meter.

• Do not allow anyone else to use the meter on themselves for testing purposes.

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Approved Cleaning and Disinfecting Products

• Super Sani-Cloth (EPA* reg. no. 9480-4)

*Environmental Protection Agency

The above product has been approved for use and can be purchased from the following sources:

• Amazon.com

• Officedepot.com

• Walmart.com

NOTE

Using cleaning and disinfecting products could result in damage to the meter. If you notice any of the following signs of deterioration after cleaning and disinfecting your meter, stop using your meter and contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578: residue around buttons, clouding of display, button malfunction, out of range controls results.

What to Clean and Disinfect

The following parts of the meter should be cleaned and disinfected:

• The area

around slots and openings (do not get any moisture in slots or openings)

• The meter display

• The entire meter surface

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7

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How to Clean and Disinfect the Meter

WARNING

j

DO NOT clean or disinfect the meter while performing a blood glucose or control test.

j

DO NOT get any moisture in slots or openings.

j

DO NOT spray anything onto the meter.

j

DO NOT immerse the meter in liquid.

Failure to follow these instructions may damage the meter and stop it from working properly.

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7

1.

2.

3.

j

Wash hands thoroughly with warm soapy water. j

Turn off the meter and place it on a flat surface, such as a table. j

Wipe the entire meter surface with the approved cleaning and disinfecting product. Always use the same product for both cleaning and disinfecting.

WARNING

The effect of using more than one product interchangeably to clean and disinfect the meter has not been tested. Always use the same product to clean and disinfect the meter.

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4.

j

Carefully wipe around the test strip slot and other openings.

Make sure that no liquid enters any opening.

5.

j

A separate Super Sani-Cloth should be used for cleaning and disinfection. For disinfecting the meter, get a new cloth and repeat steps 3 and 4, making sure that the surface stays wet for

2 minutes.

6

j

Wash hands thoroughly with soap and water.

224

NOTE

Roche has tested the approved product for a total of 208 cleaning and disinfecting cycles. This supports cleaning and disinfecting the meter once per week for a 3 year time period and allows for 52 extra cleaning and disinfecting cycles that might occur (due to blood contamination, for example) over the lifetime of the meter. This equates to approximately 1 additional cleaning and disinfecting cycle per month over the 3 year use life of the meter.

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7.3 Cleaning and Disinfecting the Lancing Device

NOTE

• Do not throw away the lancing device cap after each use. Use approved cleaning and disinfecting products on it.

• Always remove the lancet drum before cleaning or disinfecting the lancing device.

To clean and disinfect without damaging the lancing device, follow these procedures carefully.

When to Clean and Disinfect the Lancing Device

• Clean the lancing device prior to disinfecting.

• Clean and disinfect the lancing device at least once per week, or when blood is present on the surface of the lancing device.

• Do not allow anyone else to use the lancing device.

7

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Approved Cleaning and Disinfecting Products

• Super Sani-Cloth (EPA* reg. no. 9480-4)

*Environmental Protection Agency

The above product has been approved for use and can be purchased from the following sources:

• Amazon.com

• Officedepot.com

• Walmart.com

NOTE

Using cleaning and disinfecting products could result in damage to the lancing device. If you notice any of the following signs of deterioration after cleaning and disinfecting your lancing device, stop using your lancing device and contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578: residue around buttons, difficulty in priming the device, difficulty in inserting the lancet drum.

What to Clean and Disinfect

The following parts of the lancing device may be cleaned and disinfected:

• The entire lancing device surface

• The cap

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How to Clean and Disinfect the Lancing Device

WARNING

• DO NOT get any moisture into opening around button.

• Failure to follow these instructions may damage the lancing device and stop it from working properly.

1.

j


52123_07006322001.indb 227

7

2.

j

Wipe the entire surface of the lancing device and the inside of the lancing device cap with the approved cleaning and disinfecting product. Always use the same product for both cleaning and disinfecting.

3.

j

A separate Super Sani-Cloth should be used for cleaning and disinfection. For disinfecting the lancing device, get a new cloth and repeat step 2, making sure that the surface stays wet for

2 minutes.

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4.

j


WARNING

The effect of using more than one product interchangeably to clean and disinfect the lancing device has not been tested. Always use Super Sani-Cloth (EPA reg. no. 9480-4) to clean and disinfect the lancing device. Do not use any other cleaning or disinfecting solutions. Using solutions other than the Super Sani-Cloth could result in damage to the lancing device.

NOTE

Roche has tested the approved product for a total of 260 cleaning and disinfecting cycles. This supports cleaning and disinfecting the lancing device once per week for a 5 year time period. However, if the lancing device is cleaned and disinfected more than once per week (due to blood contamination, for example), please discontinue lancing device use once a total of 260 cleaning and disinfecting cycles has been reached.

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8

Maintenance

8.1 Overview

8.2 Changing the Batteries

8.3 Power-Saving Tips

8.4 Maintenance and Testing

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230

231

234

235

8

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8.1 Overview

It is important to properly care for and maintain your ACCU-CHEK Aviva Expert meter. If you have any questions about the care and maintenance of your meter, contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

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8

8.2 Changing the Batteries

1.

2.

3.

j

Remove the battery door from the back of the meter by pushing the tab in the direction of the arrow and pulling up the door. j

Remove the old batteries from the meter.

j Insert three AAA batteries with the + and - ends matching the marks in the battery compartment. j

Put the battery door back in place and snap it closed.

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WARNING

• Using batteries other than those supplied or recommended for use with the meter may significantly reduce the life of the batteries. Batteries other than those recommended may leak and corrode the battery contacts within the meter. Using batteries not supplied or recommended may void the warranty.

• Replace all batteries of a set at the same time. Newly purchased batteries should not be mixed with partially exhausted ones. Batteries of different electrochemical systems, grades, or brands should not be mixed. Failure to observe these precautions may result in some batteries in a set being driven beyond their normal exhaustion point and thus increase the probability of leakage.

• Once new batteries are inserted in the meter as directed, do not remove them until they need to be replaced. Removing and reinserting good batteries may cause issues with the internal operations of the meter.

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NOTE

• Alkaline batteries are recommended for use with the meter.

• After you change the batteries, the meter prompts you to confirm the time and date settings.

• It is a good idea to have spare, packaged batteries available.

• All test results, diary information, and settings are saved in the meter memory when the batteries are replaced.

• Rechargeable batteries may be used in the meter. However, rechargeable batteries may not maintain the same battery life as non-rechargeable batteries.

• When the Low Battery warning appears:

• If vibrate is set to On, it is disabled until the batteries are replaced.

• I f the backlight level is set to high, the medium backlight level is used until the batteries are replaced.

• If the beeper level is set to high, the medium beeper level is used until the batteries are replaced.

8

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8.3 Power-Saving Tips

To conserve battery life:

• use the low beeper setting.

• only turn on the vibrate feature when it is needed.

• turn off the meter when you are finished rather than utilizing the auto power off feature.

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8.4 Maintenance and Testing

• The meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. For detailed information on troubleshooting the meter, see Chapter 9, Troubleshooting.

• To test the meter display, turn off the meter, and then press and hold the + button. The display cycles through colors (red, blue, green, and white). If any part of the display does not change colors, contact

ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

• If you drop the meter or think it is not giving accurate results, ensure your test strips and control solution have not expired, and then perform a control test.

• Perform a control test with each new vial of test strips.

• If the meter is not working properly, contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

8

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9

Troubleshooting

9.1 Overview

9.2 Troubleshooting the ACCU-CHEK Aviva Expert Meter

238

239

9

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9.1 Overview

For most problems, 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.

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 your test strips and control solution have not expired, and then perform a control test. For further assistance, contact ACCU-CHEK



238

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9.2 Troubleshooting the ACCU-CHEK Aviva Expert Meter

Display Shows Possible Cause(s)

The display is blank or the meter will not turn on.

j

Batteries are dead.

j Display is damaged.

Above Hyper

Warning Limit

Possible Solution(s)

j

Install new batteries. See Chapter 8, Maintenance.

j Meter is defective.

j

Extreme temperature – the temperature is outside the meter operating range.

j Your test result is above the hyper warning limit set in the meter.

j Contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

j Contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

j

Move the meter to an area with proper temperature.

Wait five minutes before turning on the meter. Do not artificially heat or cool the meter.

j Treat your high blood glucose as recommended by your healthcare professional.

j

Consider checking bG, ketones, and insulin.

Beep/Vibrate Off j Beep and Vibrate settings cannot be turned off at the same time.

j Ensure that either the Beep or Vibrate setting is turned on. See Chapter 5, Changing Meter Settings.

9

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Below Hypo

Warning Limit

Bolus Advice Not

Setup


j

Your test result is below the hypo warning limit set in the meter.

j

Treat your low blood glucose as recommended by your healthcare professional.

j The meter displays a recommended number of carbohydrates for you to eat, and then retest your blood glucose.

j Advice is not provided unless it is set up through Bolus Advice in Settings Menu.

j You can continue to use the meter without bolus advice or see Chapter 5, Changing Meter Settings for instructions on how to set up bolus advice.

Bolus Advice

Timeout j

Bolus advice is no longer available for this bG result.

Carbohydrate Ratio j

Carbohydrate ratio is outside of the acceptable meter range.

Code Key Missing j

The black code key is not inserted.

j

Review data that was saved in My Data. Then, decide to modify data, add data, or begin a new bolus advice session.

j

Check your entries and contact your healthcare professional to determine the appropriate settings.

j

Turn off the meter and insert the black code key. If you need a black code key, please contact

ACCU-CHEK Customer Care Service Center at

1-1800-688-4578.

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Diary Entry Used

For Advice

Diary Results

Expired j

The diary entry selected has been used for bolus advice and modifications are not allowed.

j

Bolus advice is no longer available for this result.


j

Carefully confirm all information involving bolus advice. You cannot modify bolus advice related entries on the meter. j

Review data that was saved in My Data. Then, decide to modify data, add data, or begin a new bolus advice session.

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E-51 Bad Strip

Error

E-52 Code Key

Error j

Your blood glucose may be extremely low.

j The test strip is damaged.

j The test strip is not properly inserted into the meter.

j The code key is incorrect.


If you see this error message after you applied blood to the test strip: j If you are experiencing any of the common symptoms of low blood sugar, contact your healthcare professional immediately.

j

Treat your low blood sugar as recommended by your healthcare professional.

j If this does not match how you feel, repeat the blood glucose test and see Chapter 2, Testing Your

Blood Glucose.

If you see this error message before you applied blood to the test strip: j

Remove the test strip and reinsert it, or replace it if damaged. Check the Use By date on the test strip container. Do not use test strips past the Use by date. If the message reappears call the ACCU-CHEK


j Please contact ACCU-CHEK Customer Care Service

Center at 1-800-688-4578.

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E-53 Bad Test

Error


j

A meter or test strip error has occurred.

j

Discard the test strip and repeat the test.

j Your blood glucose may be extremely high.

j If this matches how you feel, contact your healthcare professional immediately. If it does not match how you feel, repeat the blood glucose test and see Chapter 2, Testing Your Blood Glucose. If this still does not match the way you feel, run a control test with your control solution and a new test strip. If the control result is within the acceptable range, review the proper testing procedure and repeat your blood glucose test with a new test strip. If the E-53 error still appears for your blood glucose test, your blood glucose test result may be extremely high and above the system’s reading range.

Contact your healthcare

professional immediately. If the control test result is not within the acceptable range, see Chapter 3,

Control Testing.

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E-54 Not Enough

Sample

E-55 Code Key

Expired

E-56 Sample

Applied Early


j

Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test has started.

j

Discard the test strip and repeat the test.

j The white code key is from an expired lot of test strips.

j This message may appear when using a white code key in the meter. It means the test strips expire at the end of the current month. At the end of the month, discard the white code key and any remaining test strips. Insert a black code key. Make sure the time and date in the meter are correct. If you need a black code key, please contact


1-800-688-4578.

j

Blood or control solution was applied to the test strip before the Apply Sample screen appeared on the display.

j

Discard the test strip and repeat the test with a new test strip.

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E-57 Electronic

Error j

An electronic error has occurred or, in rare cases, a used test strip was removed and reinserted.

E-58 Temp. Error j The temperature is above or below the proper range for the meter.


j

Turn off the meter and remove the batteries. Wait at least 20 seconds prior to reinserting the batteries.

Turn on the meter and perform a blood glucose or control test. If the problem persists, contact


1-800-688-4578.

j Move the meter to an area within the proper temperature range indicated for test strip use in the test strip package insert. Wait 5 minutes before turning on the meter. Repeat the test. Do not artificially heat or cool the meter.

j

Insert new batteries. See Chapter 8, Maintenance.

E-59 Battery

Empty

E-60 Time/Date

Error j

The batteries are extremely low.

j The time and date settings may be incorrect.

j

You have changed the batteries.

j Ensure the time and date are correct and adjust, if necessary. See Chapter 5, Changing Meter

Settings.

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246

Display Shows Possible Cause(s) Possible Solution(s)

HI bG Warning j

Your blood glucose may be higher than the measuring range of the system.

j

If you are experiencing any of the common symptoms of high blood glucose, contact your healthcare professional immediately.

j Treat your high blood glucose as recommended by your healthcare professional.

j

Consider checking bG, ketones, and insulin.

Insulin Sensitivity j Insulin sensitivity is outside of the acceptable meter range.

j Check your entries and contact your healthcare professional to determine the appropriate settings.

Invalid Bolus

Advice Times

Invalid Date

Invalid Hyper

Values j The acting time value is less than the offset time.

j The date entered is invalid

(dates for reminders cannot be set to occur in the past).

j The hyper warning limit value must be greater than all of your target ranges in the time block settings.

j The acting time value must be set equal to or greater than the offset time. Reset the acting time value or revise the offset time.

j Re-enter date.

j Reset the hyper warning limit or revise the target ranges in time blocks and re-enter the hyper warning limit.

j

Enter a hyper warning limit that is above the target ranges of your time blocks. See Chapter 5,

Changing Meter Settings.

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Invalid Hypo Values j

The hypo warning limit value must be less than all of your target ranges in the time block settings.

Invalid Record

Time/Date

Invalid Target

Range


j

Reset the hypo warning limit or revise the target ranges in time blocks and re-enter the hypo warning limit.

j Enter a hypo warning limit that is below the target ranges of your time blocks. See Chapter 5,

Changing Meter Settings.

j Re-enter time/date.

j The time/date entered is invalid (Add Data entries cannot be set to occur in the future).

j

The lower target range value is above the upper target range value.

j

The range selected conflicts with your hyper and/or hypo warning limit settings.

j

Reset the target range values.

j

Enter the correct lower target range value and upper target range value. See Chapter 5, Changing

Meter Settings.

j

Reset range or revise warning limit settings and re-enter range.

j Enter the correct lower target range value and upper target range value. See Chapter 5, Changing

Meter Settings.

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LO bG Warning j

Your blood glucose may be lower than the measuring range of the system.

Meter Battery Low j Battery power is low.


j

Treat your low blood glucose as recommended by your healthcare professional.

j If you are experiencing any of the common symptoms of low blood glucose, contact your healthcare professional immediately.

j Install new batteries. See Chapter 8, Maintenance.

No bG with Bolus j You have not tested your bG and are attempting to deliver a bolus.

j It is recommended to test bG before delivering insulin.

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Test Strips Expiring j

The test strips expire at the end of the current month.


j

This message may appear when using a white code key in the meter. It means the test strips expire at the end of the current month. At the end of the month, discard the white code key and any remaining test strips. Insert a black code key. Make sure the time and date in the meter are correct. If you need a black code key, please contact


1-800-688-4578.

j

Ensure the time and date are correct and adjust, if necessary. See Chapter 5, Changing Meter

Settings.

NOTE

• For additional information on errors and warnings, see Chapter 6, Icons, Reminders, Warnings, and

Errors.

• If you have a question or if you see any other error screen, please contact ACCU-CHEK Customer Care

Service Center at 1-800-688-4578.

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10

Technical Information

10.1 Overview

10.2 Product Limitations

10.3 Specifications

10.4 Product Safety Information

10.5 Disposing of the Meter, Strips, Lancets, and Batteries

10.6 Warranty and Limited License

10.7 Additional Supplies

10.8 Information for Healthcare Professionals

258

260

267

268

252

253

254

256

10

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10.1 Overview

This chapter provides you with important performance information regarding the meter.

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10.2 Product Limitations

Please read the literature packaged with your test strips to find the latest information on product specifications and limitations.

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10.3 Specifications

Blood volume

Sample type

Measuring time

Measuring range

Test strip storage conditions

Meter storage conditions (with batteries inserted)

System operating conditions

Relative humidity operating range

Memory capacity

Automatic power off

Refer to the test strip package insert.

Fresh capillary whole blood




-4 °F to 122 °F



1,000 diary records

2 minutes

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Power supply

Display

Dimensions

Weight

Construction

Protection class

Meter type

Control solution storage conditions

Interface

Three AAA batteries (recommended: alkaline)

LCD

3.7 x 2.1 x 1 inches (LWH)

Approximately 3.6 oz with batteries inserted

Hand-held

III

The ACCU-CHEK Aviva Expert meter is suitable for continuous operation.

36 °F to 90 °F

IR; LED/IRED – Class 1

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10.4 Product Safety Information

WARNING

Choking hazard. Small parts. Keep away from children under the age of 3 years.

Electromagnetic Compatibility

This meter meets the electromagnetic immunity requirements as per EN ISO 15197 Annex A. The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000-4-2. In addition, it meets the electromagnetic emissions requirements as per EN 61326. Its electromagnetic emission is thus low.

Interference from other electrically driven equipment is not to be anticipated.

Performance Analysis

The ACCU-CHEK Aviva Expert system (ACCU-CHEK Aviva Expert meter with ACCU-CHEK Aviva Plus test strips) is calibrated with venous blood containing various levels of glucose. The reference values are obtained using the hexokinase method. For method comparison, the results were compared with results obtained using the hexokinase method with deproteinization (automatic analyzer). The hexokinase method is traceable to an

NIST standard.

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Measuring Principle

Refer to your test strip package insert for more information.

WARNING

• Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use this meter close to sources of strong electromagnetic radiation.

• To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.

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10.5 Disposing of the Meter, Strips, Lancets, and Batteries

WARNING

• Any product coming in contact with blood is considered contaminated (potentially infectious).*

• During normal testing any blood glucose meter may come in contact with blood. Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions.

Roche is committed to recycling and sustainability. Please consider the following points when disposing of your used testing materials:

• Comply with any laws or ordinances relating to the disposal of sharps and/or contaminated products.

Contact your local health department or other appropriate authorities for proper handling and disposal of used meters, used test strips, used lancets, and used batteries.

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• Consider recycling of the meters and batteries at an appropriate facility. Be aware the meter is potentially hazardous electronics scrap (e-scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be disposed of accordingly.

• Decontaminate the meter before recycling or disposing.

• Users in professional environments (i.e., healthcare professionals) should follow their existing policies and procedures that govern the proper handling and disposal of potentially infectious waste, e-scrap, and batteries.

*29 CFR 1910.1030-Bloodborne pathogens (Code of Federal Regulations)

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10.6 Warranty and Limited License

ACCU-CHEK Aviva Expert Meter Limited 3-Year Warranty

Roche Diagnostics warrants to the original purchaser of the meter that your ACCU-CHEK Aviva Expert meter will be free from defects in materials and workmanship for 3 years from the date of purchase. If during this

3-year period, the meter does not work properly because of a defect in materials or workmanship, Roche

Diagnostics will replace it with a new ACCU-CHEK Aviva Expert meter or equivalent product free of charge.

The warranty on the replacement meter will expire on the date of the original warranty expiration or 90 days after the shipment of a replacement system, whichever period is longer. The purchaser’s exclusive remedy with respect to the ACCU-CHEK Aviva Expert meter shall be replacement.

This warranty does not apply to the performance of an ACCU-CHEK Aviva Expert meter that has been damaged by accident or has been altered, misused, tampered with, or abused in any way.

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THE PRECEEDING WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE DIAGNOSTICS MAKES

NO OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTY

OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL ROCHE DIAGNOSTICS

BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT,

SPECIAL, OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR

OPERATION OF THE METER OR ITS PARTS. NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A

PARTICULAR PURPOSE, IF ANY IS IMPLIED FROM THE SALE OF THE METER, SHALL EXTEND FOR A LONGER

DURATION THAN FOUR YEARS FROM THE DATE OF PURCHASE.

Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specific legal rights, which vary from state to state.

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Warranty and Service Instructions

All requests for return of ACCU-CHEK Aviva Expert meters under the preceding warranty or service policy must be made to ACCU-CHEK Customer Care Service Center. You will be mailed a return authorization label, which must be affixed to your carton for shipping the system to Roche Diagnostics. Cartons received without this label will be returned to you at your expense.

Customers experiencing difficulties should review the troubleshooting information in Chapter 9 of this booklet.

Further inquiries should be directed to ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

Be sure to fill out and mail the Warranty Card that comes with the ACCU-CHEK Aviva Expert system.

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Limited License

CAUTION

A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK AVIVA EXPERT SYSTEM—READ CAREFULLY THE

LIMITATIONS RECITED BELOW.

The ACCU-CHEK Aviva Expert 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); 8,298,401 (expires 4-October-2022); 8,303,801

(expires 4-October-2022); 8,329,026 (expires 4-October-2022); 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); and 7,604,721 (expires 12-August-2026). A license to use the ACCU-CHEK Aviva Expert system is required until the last-to-expire patent listed above and is only granted when the ACCU-CHEK Aviva

Expert 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 Expert 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 Expert system.

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Using the ACCU-CHEK Aviva Expert system indicates your acceptance of the restricted license to use the ACCU-CHEK Aviva Expert 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 Expert 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 Expert system are voided by use of the ACCU-CHEK Aviva Expert 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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CAUTION

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 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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10

10.7 Additional Supplies

Test Strips

ACCU-CHEK Aviva Plus 50 ct test strips

ACCU-CHEK Aviva Plus 100 ct test strips

Control Solutions

ACCU-CHEK Aviva 2 level control solutions

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10.8 Information for Healthcare Professionals

WARNING

Healthcare Professionals: Follow the infection control procedures appropriate for your facility.

A drop of fresh, whole blood is required to perform a blood glucose test. Refer to the test strip package insert for additional healthcare professional information.

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g

Hyper

Hypo

IR bG

Carbs

CC

°F

Appendices

Appendix A: Abbreviations

Abbreviation

AM

Definition

Ante Meridiem (12-hour clock notation for “before noon”)

BE Bread Equivalent (equal to 12 grams of carbohydrates)

Blood Glucose (blood glucose)

Carbohydrates

Carbohydrate Choice (equal to 15 grams of carbohydrates)

Degrees Fahrenheit

Grams

Hyperglycemia (high blood glucose)

Hypoglycemia (low blood glucose)

Infrared

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Abbreviation

ISO

PM

SD

U

KE

LCD mg/dL

N/A

NIST

NPH

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52123_07006322001.indb 270

Definition

International Organization for Standardization

Kohlenhydrateinheit (equal to 10 grams of carbohydrates)

Liquid Crystal Display

Milligrams per Deciliter

Not Applicable

National Institute of Standards and Technology (United States)

Neutral Protamine Hagedorn

Post Meridiem (12-hour clock notation for “after noon”)

Standard Deviation

Units (basal insulin units)

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Appendix B: Carb Units

For carbohydrates, the following units of measure are available on the meter.

Abbreviation Unit of Measurement Gram Equivalent

g Grams* 1 gram

KE Kohlenhydrateinheit 10 grams

BE

CC

Bread Equivalent

Carbohydrate Choice

12 grams

15 grams

*Standard unit of measure in the U.S.

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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 Expert 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: Meter Settings and Range Limits

Data Type

Acting Time

Unit of Measurement MIN MAX Increments Default Setting

hours:minutes 1:30 8:00 0:15 4:00

Basal Insulin Units 0 bG Threshold (High) mg/dL bG Threshold (Low) mg/dL

Bolus Insulin Units

Carb Ratio (carbs)

Carb Ratio (insulin) grams

BE

KE

CC

Units

1

0.1

0.1

0.1

0.1

0 99 Insulin

Increment

120 350 1

50

0

240

20

24

16

50

100 1

50 Insulin

Increment

1

0.1

0.1

0.1

0.1

Hyper Warning Limit

Hypo Warning Limit

0

No entry (“--- g”)

No entry (“--- BE”)

No entry (“--- KE”)

No entry (“--- CC”)

1

Carbohydrates grams

BE

KE

CC

0

0

0

0

240

20

24

16

1

0.1

0.1

0.1





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Data Type

Exercise 1 (health event)

Unit of Measurement MIN

%

Exercise 2 (health event)

%

Hyper Warning Limit mg/dL

-50

-50

MAX Increments Default Setting

50

50

1

1

180 350 1

0

0

300

Hypo Warning Limit mg/dL

Illness (health event) %

Insulin Increment Units

Insulin Sensitivity (bG) mg/dL

Insulin Sensitivity

(insulin)

Max Bolus

Units

Units

50

-50

0.5

1

0.1

0

90

50

1

1

1

999 1

50 0.1

50

70

0

0.5

No entry (“---mg/dL”)

1

1 or 0.5 (per the insulin increment value)

No entry (“---U”)

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Data Type

Meal Rise (bG)

Unit of Measurement MIN MAX Increments Default Setting

mg/dL 50 200 1 50

1:00 Offset Time hours:minutes

Premenstrual (health event)

Snack Size (carbs)

% grams

BE

KE

CC

Stress (health event) %

0:45 Acting

Time

-50

0

0

0

0

-50

50

24

2

2.4

1.6

50

0:15

1

Target Range Upper

Value

Target Range Lower

Value mg/dL mg/dL

100

50

300

140

1

1

1

The insulin increment is used when entering bolus and basal insulin data.

1

0.1

0.1

0.1

1

0





0

140

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The following are the default settings for bG test reminders. To turn on a bG test reminder, see Setting Alarm

Clock Reminders: bG Test, Other in Chapter 5, Changing Meter Settings.

Test Reminder

1

Default Time of Day

7:00 am

6

7

8

2

3

4

5

9:00 am

11:00 am

12:00 pm

2:00 pm

4:00 pm

7:00 pm

10:00 pm

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The following are the default settings for the time blocks. Talk to your healthcare professional about setting up time blocks to help you manage your diabetes. To adjust the time blocks, see Chapter 5, Changing Meter

Settings.

Time Block

1

2

12-Hour Format

12:00 am–5:30 am

5:30 am–11:00 am

3

4

5

11:00 am–5:00 pm

5:00 pm–9:30 pm

9:30 pm–12:00 am

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Appendix E: References

1. FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for

Transmitting Bloodborne Pathogens: Initial Communication, (2010). Update 11/29/2010.” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. Accessed March 20, 2012.

2. CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting

Bloodborne Pathogens, (2010).” http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.

Accessed March 20, 2012.

3. Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, Ph.D., M.P.H., and

David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. “Guideline for Disinfection and Sterilization in Healthcare Facilities. Atlanta.”

4. US Environmental Protection Agency Office of Pesticide Programs “List D: EPA’s Registered Antimicrobial

Products Effective Against Human HIV-1 and Hepatitis B Virus.” January 9, 2009. http://www.epa.gov/ oppad001/list_d_hepatitisbhiv.pdf. Accessed January 25, 2011.*

* Enviromental Protection Agency

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Glossary

Term

7-day average

Acting Time

Advice Options

After High bG Reminder

After Low bG Reminder

After Meal Reminder

Alarm

52123_07006322001.indb 279

Definition

Includes results generated today and the previous 6 days.

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.

Factors that influence bolus advice calculations including meal rise, snack size, acting time, and offset time.

A reminder to retest your blood glucose. When enabled, this reminder occurs after a high blood glucose test result.

A reminder to retest your blood glucose. When enabled, this reminder occurs after a low blood glucose test result.

A reminder to retest your blood glucose. When enabled, this reminder occurs after a meal. For this reminder to occur, you must enter carbohydrate data greater than the snack size amount.

Audible or vibrating (silent) notification indicating a reminder, warning, or error.

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Term

Basal bG Test Reminders bG Threshold

Blood Glucose (bG)

Bolus

Bolus Advice

Bolus Advice Options

Carb Ratio

Carbohydrates (or Carbs)

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Definition

A dose of long-acting insulin intended to maintain normal blood glucose levels between meals and at night.

Reminders to retest your blood glucose after a high blood glucose test result, after a low blood glucose test result, or after a meal.

A bG test reminder setting. The upper limit for your blood glucose for a high bG test reminder and the lower limit for your blood glucose for a low bG test reminder.

The level of glucose in blood.

The delivery of insulin all at once rather than slowly throughout the day, usually used to compensate for meals or high blood glucose.

When enabled, bolus advice provides recommendations on the amount of insulin for food intake and for correcting blood glucose levels that are not within your target range.

See Advice Options.

The amount of insulin necessary to account for a certain number of carbohydrates.

Carbohydrate foods include sugars and starches. Carbohydrates can raise blood glucose levels slowly or rapidly. Carbohydrates are generally counted to calculate a bolus insulin dose.

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Term

Control Result

Control Test

Current Date

Current Time

Day

End Time

Health Events

HI

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Definition

Value displayed on meter as the result of a control test. When the Control

Result is within the range shown on the label of the test strip container, then the test strips and the meter are working properly.

A meter test using control solution which lets you know that the meter and test strips are working properly.

Refers to the date you set through the menu Settings and then in the

Time/Date screen.

Refers to the time you set through the menu Settings and then in the

Time/Date screen.

Period of time starting at 12:00 am and ending at 11:59 pm.

The end time of a time block.

A pop-up menu selection (Exercise 1, Exercise 2, Stress, Illness,

Premenstrual, or Fasting) that allows information to be stored with a blood glucose test result or in a diary record and percentages that could adjust bolus advice recommendations for your current health status or activities.

The test result is above the meter’s measurement range.

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Term

Hyper

Hyper Warning Limit

Hypo

Hypo Warning Limit

Insulin Increment

Insulin Sensitivity

Ketones

Key Lock

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Definition

Hyperglycemia: an abnormally high level of glucose in the blood.

When your blood glucose test result is above the hyper warning limit, a warning is displayed.

Hypoglycemia: an abnormally low level of glucose in the blood.

When your blood glucose test result is below the hypo warning limit, a warning is displayed.

The meter rounds off the insulin amount to be delivered, which the meter calculates if bolus advice is set up, or when you manually enter bolus and basal insulin data into the diary. The insulin increment can be set to 0.5 or 1 U.

The amount of insulin necessary to lower your blood glucose by a certain amount.

A by-product or waste product when your body burns stored fat for energy. Ketones are produced when there is not enough insulin to help your body use glucose for energy. Without enough insulin, glucose builds up in the blood.

A meter function which disables the keys (buttons) in order to prevent its unintended use.

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Term

LO

Max Bolus

Meal Rise

Meal Time

Meter

Note

NPH Insulin

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Definition

The test result is below the meter’s measurement range.

The maximum amount of bolus insulin to be delivered at one time. A bolus that is larger than the max bolus amount requires an additional confirmation. This serves as a safety measure against unintended large boluses. You should ask the advice of your HCP for delivering large doses of insulin.

During or after meals, an increase in blood glucose levels is considered normal, or “allowed,” within a certain range, even though a meal bolus has been delivered. A meal rise is in effect for a specified time period.

A pop-up menu selection (pre-meal, post-meal, bedtime, or other) that allows information to be stored with a blood glucose test or in a diary record.

Blood glucose meter.

Additional information.

Neutral Protamine Hagedorn. An intermediate-acting insulin that, on average, starts to lower blood glucose within 1 to 2 hours after injection. It has its strongest effect 6 to 10 hours after injection but keeps working about 10 hours after injection. Also called N insulin.

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Term

Offset Time

Pre-Mixed Insulin

Remind After

Reminder

Snack Size

Snooze

Soft Keys

Standard Deviation

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Definition

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.

A commercially produced combination of two different types of insulin.

A bG test reminder setting. The amount of time after a high blood glucose test result, after a low blood glucose test result, or after a meal you want the reminder to occur.

When enabled, reminders occur to remind you to test your blood glucose, to retest your blood glucose or of an event or activity.

The amount of carbohydrates that is not to be counted as a regular meal with the expected meal rise.

Delay of some reminders for a defined time period.

Two buttons under the meter display used to navigate through the user interface. Just above each soft key, the meter display shows the selection (i.e., Save, Cancel, Back, etc.).

As it is used in this owner’s booklet, standard deviation measures how widely spread the bG test results are (e.g., if the bG test results are close to the bG average, then the standard deviation is small).

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Term

Start Time

Target Range

Time Blocks

Time Range

User

Warning

Warning Limits

Definition

The start time of a time block.

The desired upper and lower limits of your blood glucose level considered acceptable as set by your healthcare professional.

Up to eight time periods within one day to facilitate your changing insulin needs throughout the day.

The user sets the duration of time. There is a start and end time.

A person using the meter.

Describes items and conditions that present hazards and may cause personal injury.

See Hyper Warning Limit or Hypo Warning Limit.

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286

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Index

A

abbreviations, 269–271 acting time, 153–155 , 164 active insulin, 47–49 advice options, 153–155 , 163–164 after high bG test reminder, 131–135 , 198 , 200 ,

202 , 204 after low bG test reminder, 131–135 , 198 ,

201–203 after meal bG test reminder, 131–135 , 198–

199 , 202 , 205 alarm clock reminder, bG test, 28 , 137–140 , 202 , 206 injection, 28 , 137–140 , 202 , 206–207 other, 28 , 137–140 , 202 , 206–207 appetite, increased, 57

B

backlight, 21 , 191–192 button, 15 , 18–19 batteries, 16 changing, 231–233 low, 30 , 177 , 192 type, 231 , 233

BE, 174–176 , 271 beeper, setting, 30 , 177–179 bG threshold, 133–134 blood glucose averages, 91–92 blood glucose test, performing, 39–47 reminder, 28 results, 44 , 47–56 unusual results, 51–56 , 55 blurred vision, 57 bolus advice, 23 , 147–155 bolus advice options. See advice options buttons, 15 , 18–20

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C

carbohydrates, 47–50 , 84 , 87 units of measure, 174–176 , 271 carb ratio, 148 , 151 , 159 , 240 carbs. See carbohydrates

CC, 174–176 , 271 cleaning, lancing device, 225–227 meter, 220–224 code key, 17 , 240 , 242 , 244 code number, 41 , 64 control solution, 16 , 62 , 65 control test, performing, 61 , 63–68 results, 66–67 , 69–72 results, troubleshooting, 73–74

288

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D

data, 23 adding, 48–50 , 86–88 downloading to a computer, 24 , 126–128 modifying, 79–85 reporting, 89–125 time change, 94–95 , 98–99 trends, 93–101 viewing, 79–85 date, reminders, 28 , 142–146 , 202 setting, 180–182 display, 15 , 21 , 239 disposing, meter, strips, lancets, batteries,

258–259 dr. visit reminder, 142–146 , 199–200 , 202

E

end time, 150 , 152–153 , 158–159 , 185–186 ,

188 , 190 errors, list of, 213–215

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F

fatigue, 57 frequent urination, 57

G

g (grams), 174–176 , 271 graph, standard day, 103–106 standard week, 112–115 target, 120–122 trend, 94–97

I

icons, listing, injection

81 , infrared (IR) window, injection reminder. See alarm clock reminder, insulin sensitivity,

K

KE, 174–176 key lock, 20 ,

, 271

22 ,

195–196

15–16

148 key sound, setting,

, 151

168–170

,

177–179

, 127

159–160

H

headache, 57 health events, 27 , 47–50 , 84 , 87 , 153 , 161–162 high bG retest reminder, 200 , 204 hyper warning limit, 24 , 165–167 , 239 , 246 hypo warning limit, 24 , 165–167 , 240 , 247

L

lab test reminder, 142–146 , 200–202 lancing device, 42–43 language, setting, 171–173 lock. See key lock low bG retest reminder, 201–203

, 246

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290

M

maintenance, meter, meal rise, meal time, meter,

153 , 155

47–50 ,

,

235

164

84–85 settings and range limits, summary of features, 15 ,

273–277

21–29

R

rapid heartbeat, 57 reminders, important information, 202–207 list of, 198–201 priority, 202 reminders, blood glucose test. See blood glucose test, reminder

N

navigation,

Neutral Protamine Hagedorn (NPH), numbness,

P

29–34

57 power button, 15 , power-saving tips,

18–19

234

147

O

offset time, 154–155 , 164 other reminder. See alarm clock reminder, other

S

screen, features, 30–32 scroll bar, 31 snack size, 134–135 , 153–155 , 164 snooze, 131 , 137 , 197–198 soft keys, 15 , 18–20 sound, 30 setting, 177–179 specifications, meter, 254–255 standard day, reporting, 102–110 standard deviation, 89–90 , 116

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standard week, reporting, 111–118 supplies, 267 sweating, 57 symbols, explanation, 272

T

table, standard day, 107–110 standard week, 116–118 target, 123–125 trend, 98–101 target range, 148 , 151 , 159 , 183–185 , 247 target, reporting, 119–125 test results, storing, 77–78 unusual, 55–56 test strip, 42 , 64 , 249 thirst, increased, 57 time blocks, 25–26 , 147–160 , 183–190 , 277 time format, setting, 180–181 time, setting, 180–182 tingling, 57 trembling, 57 troubleshooting, 239–250

U

units of measure. See carbohydrates, units of measure unlock. See key lock use by date, 37 , 55 , 62 , 73

V

vibrate setting, 30 , 177–179

W

warnings, list of, 208–213 warranty, 260–262

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292

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294

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LAST UPDATE: 2013-07

10/18/13 2:31 PM

© 2013 Roche Diagnostics

Assembled in USA.

Roche Diagnostics Corporation

9115 Hague Road

Indianapolis, IN 46256 www.accu-chek.com

52123_07006322001.indb 1

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

AVIVA EXPERT, and FASTCLIX are trademarks of Roche.

BLOOD GLUCOSE METER

Standard Owner’s Booklet for Single Patient Use Only

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