Accu-Chek Aviva Combo meter—Standard Owner`s Booklet English

Accu-Chek Aviva Combo meter—Standard Owner`s Booklet English

Aviva Combo

©2013 Roche Diagnostics

Assembled in USA.

Distributed by:

Roche Health Solutions Inc.

11800 Exit 5 Parkway, Suite 120

Fishers, IN 46034

Phone: 1-800-280-7801

Fax: 1-888-810-0758

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

AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and

FASTCLIX are trademarks of Roche.

The Bluetooth

®

word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and product names are the property of their respective owners.

BLOOD GLUCOSE METER

Standard Owner’s Booklet for Self-Testing Only

6/11/13 3:57 PM

Roche USA – 51638

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Roche USA – 51638

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V6/3 – 00048010155/C – Magenta –

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V6/4 – 00048010155/C – Yellow –

Roche USA – 51638

V6/5 – 00048010155/C – PMS 287 –

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V6/6 –00048010155/C – PMS 5445 –

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LAST UPDATE: 2012-08

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Before You Start Testing

About the meter and test strips

• Carefully read and follow the instructions in the Getting Started Guide, the Standard Owner’s Booklet, the

Advanced Owner’s Booklet, and Package Inserts for the test strips and control solutions. Not following the instructions may lead to a wrong result or improper treatment, causing you health problems.

• Set the time and date on your meter before you begin testing.

• Inspect the test strip container before using the test strips for the first time. If you see any damage to the container cap or if anything prevents the cap from closing properly, do not use the test strips. Contact

ACCU-CHEK Customer Care Service Center at 1-800-688-4578. Damaged test strips can cause inaccurate results, which could lead to improper treatment.

• Carefully dispose of used test strips and lancets.

• Home use of the ACCU-CHEK Aviva Combo system is limited to capillary whole blood testing.

NOTE

The terms “blood sugar” and “blood glucose” have the same meaning. In this manual we will use the term “blood glucose” when referring to “blood sugar.”

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Roche USA – 51638

V4/1 – 00048010155/C – Black –

Roche USA – 51638

V4/2 – 00048010155/C – Cyan –

Roche USA – 51638

V4/3 – 00048010155/C – Magenta –

Roche USA – 51638

V4/4 – 00048010155/C – Yellow –

About Your New Meter

• The meter is designed and can be used for testing fresh capillary whole blood samples (for example, blood from a fingertip).

• Only use ACCU-CHEK Aviva Plus test strips. Other test strips will give inaccurate results.

• Although you always apply whole blood to the test strip, the system has been calibrated to deliver plasma-like values for easier comparison to lab results.

• The meter, test strips, and control solution are only for use outside the body (in vitro). Do not eat the test strips. Do not swallow or inject the control solution, or use the control solution for any purpose other than testing the ACCU-CHEK Aviva Combo system.

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About Testing Yourself or Others

• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you think you are dehydrated, call your healthcare professional right away.

• Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia). Others, such as children or people who are unconscious or have certain disabilities, may not be able to communicate their symptoms to caregivers. For these reasons, do not change any treatment without first talking to a healthcare professional.

• Run a control test when you open a new box of test strips or if you think that your test result is incorrect.

Running a control test lets you know that the meter and test strips are working properly.

• If peripheral circulation is impaired, collection of fresh capillary whole blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level. This may apply in the following circumstances: severe dehydration as a result of diabetic ketoacidosis or due to hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA

Class IV, or peripheral arterial occlusive disease.

• Not to be used for patients who are critically ill.

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

• It is always a good idea to have a back-up testing method available. Failure to test could cause a delay in treatment decisions and lead to a serious medical condition. Examples of back-up testing methods include a back-up meter or testing by a lab. Ask your healthcare professional or pharmacist about other possible back-up methods.

DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH

HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.

If your blood glucose result doesn’t match how you feel and you have followed the instructions in your owner’s booklets, follow your healthcare professional’s instructions or call your healthcare professional.

Special Information to Consider When Using This Meter

• Do not use this device to measure blood glucose if you or a person to whom you are providing care is experiencing cardiovascular collapse (severe shock) or decreased peripheral blood flow.

• Consult your healthcare professional to determine if it is appropriate for your child to be taught how to use the meter system or any other medical products.

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Contents

Before You Start Testing

Introduction

The ACCU-CHEK Aviva Combo System

1 Understanding Your New System

1.1 Overview

1.2 The ACCU-CHEK Aviva Combo Meter at a Glance

1.3 The ACCU-CHEK Spirit Combo Insulin Pump at a Glance

1.4 Summary of Features

1.5 Screen Content and Navigation

2 Testing Your Blood Glucose

2.1 Overview

2.2 Using the ACCU-CHEK Aviva Combo System

2.3 Performing a Blood Glucose Test

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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

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, Other

5.4 Setting Date Reminders: Dr. Visit, Lab Test, Infusion Set Change

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

5.11 Turning Bluetooth

®

Wireless Technology On or Off

5.12 Pairing the Meter and Pump

5.13 Setting the Beeper, Vibrate, Key Sound

5.14 Setting the Time Format, Time, Date

5.15 Setting Time Blocks: Bolus Advice Not Set Up

5.16 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 Combo 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

Appendices

Appendix A: Abbreviations

Appendix B: Carb Units

Appendix C: Explanation of Symbols

Appendix D: Meter Settings and Range Limits

Appendix E: References

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Glossary

Index

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Introduction

Whether the ACCU-CHEK Aviva Combo meter is your first blood glucose meter or you have used a meter for some time, please take the time to read the Getting Started Guide, the Standard Owner’s Booklet, and the

Advanced Owner’s Booklet carefully before you use your new meter. To use it correctly and dependably, you need to understand its operation, screen displays, and all individual features.

Your new meter includes three booklets:

• Getting Started Guide:

Use this booklet to set up the meter.

• Standard Owner’s Booklet:

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

• Advanced Owner’s Booklet:

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

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

This booklet includes information about:

• Understanding your new ACCU-CHEK Aviva Combo system

• Testing your blood glucose

• Control testing

• Managing your data

• Changing the meter settings

• Understanding the icons, reminders, warnings, and errors

• Maintenance

• Cleaning and disinfecting the meter and lancing device

• 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 Combo System

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

• Controlling your ACCU-CHEK Spirit Combo pump

• Administering a bolus

• Bolus advice

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

• Data management

• Data transfer

• Date reminders

• bG test reminders: Alarm clock, 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.

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NOTE

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

Intended Use

The ACCU-CHEK Aviva Combo blood glucose system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control.

The ACCU-CHEK Aviva Combo 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 Combo blood glucose monitoring system. The ACCU-CHEK Aviva Plus test strips are for use with the

ACCU-CHEK Aviva Combo blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The ACCU-CHEK Aviva Combo meter can also be used to interface with, and remotely control, the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.

The system includes:

• ACCU-CHEK Aviva Combo meter with batteries and pre-inserted black code key

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

• ACCU-CHEK Aviva control solution*

• ACCU-CHEK FastClix Lancing Device*

• ACCU-CHEK FastClix lancet drum*

*may be sold separately

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WARNING

• Any object coming into contact with human blood is a potential source of infection (see: Clinical and

Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections;

Approved Guideline – Third Edition; CLSI document M29-A3, 2005).

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

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 Combo system is intended for single patient use and should not be shared.

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1

Understanding Your New System

1.1 Overview

1.2 The ACCU-CHEK Aviva Combo Meter at a Glance

1.3 The ACCU-CHEK Spirit Combo Insulin Pump at a Glance

1.4 Summary of Features

1.5 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, contact ACCU-CHEK

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

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

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1.2 The ACCU-CHEK Aviva Combo 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

Turns 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 pre-inserted 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

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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 Name Function

<

Left Arrow j Move or scroll to the left in a screen.

>

Right Arrow j Move or scroll to the right in a screen.

x

Up Arrow j Move or scroll up in a screen.

z

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 j Select a menu or option.

j

Save changes and exit the entry field.

*

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

Turn Bluetooth wireless technology on and off (press and hold

* in the

BLUETOOTH screen).

+

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.

With the meter turned off, press and hold

*

and then press

+

.

Meter/Pump

Pairing j

Begins meter and pump pairing.

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1.3 The ACCU-CHEK Spirit Combo Insulin Pump at a Glance

Menu Key

Cycles through menus, functions, and information screens

OK Key

Selects current settings displayed on screen, saves changes, exits a screen, and allows the user to view the

QUICK INFO screen

Display

Shows menus, messages, and data stored in the pump memory

Cartridge

Holds insulin

Adapter

Connects the cartridge to the infusion set

Up Key

Moves forward in an information screen, increases a setting, turns on the backlight, programs a Quick

Bolus, cancels a Quick Bolus, and turns off the STOP-Warning

Down Key

Moves backward in an information screen, decreases a setting, programs a Quick Bolus, cancels a Quick Bolus, and turns off the

STOP-Warning

Infusion Set

Connects the pump to your body to deliver insulin

1

For information about the pump, see the ACCU-CHEK Spirit Combo Insulin Pump User Guide.

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1.4 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)

If bolus advice is set up on the meter and the meter recently communicated with the pump, the amount of active insulin is displayed on the detailed bG Result screen.

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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.

Using the Meter with the Pump

• The meter can communicate with and remotely control your pump.

• Pump information is automatically downloaded to the meter when Bluetooth wireless technology is activated.

• The meter must be paired with the pump.

• For more information, see the Advanced Owner’s Booklet.

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Administering a Bolus

Using your new meter, you can deliver a bolus:

• Remotely on your pump using Bluetooth wireless technology

• Using the bolus advice feature on the meter

• Independently on your pump

• Using an insulin pen or syringe

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.

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

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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.

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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,” you can set reminders for “Other” for any other daily reminder.

• You can set up to eight reminders per day.

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

Date Reminders

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

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

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1.5 Screen Content and Navigation

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

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

Bluetooth Wireless Technology Icon

Indicates whether the Bluetooth wireless technology is on, off, or connecting

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NOTE

• To select an item on a menu, press x

or z

to highlight (blue) the menu item and then press

=

.

• When using the meter to remotely control your pump, the buttons of your meter have differing functions. For more information, see the Advanced Owner’s Booklet.

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Bluetooth Wireless Technology Icon Communication States

You may turn Bluetooth wireless technology on or off at any time using the meter.

Icon Communication State

Bluetooth wireless technology is on. The meter and pump are communicating.

Bluetooth wireless technology is off . The meter and pump are not communicating.

Bluetooth wireless technology is on. However, the meter and pump are not communicating.

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Connecting to the Pump screen during pairing:

This screen appears when Bluetooth wireless technology is on and the meter is connecting to the pump.

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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.

1

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.

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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 Combo 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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2

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2.1 Overview

It is important to understand how to perform a blood glucose test properly.

NOTE

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

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2.2 Using the ACCU-CHEK Aviva Combo System

Before You Start Testing

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.

• Do not refrigerate, freeze, or expose strips to heat, moisture or humidity. Temperatures outside the required range, as well as moisture and humidity, can damage your test strips and lead to inaccurate results.

• 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

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.

• Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allow anyone else to test with the meter or lancing device.

• It is important to keep the meter and lancing device clean and disinfected. For instructions on how to clean and disinfect the meter and lancing device, see Chapter 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.

• If your blood glucose test result does not match how you feel, perform a fingertip test to confirm your result. If the fingertip test result still does not match how you feel, contact your healthcare professional.

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. j

Prepare the lancing device for a fi ngertip 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 and data has recently been read from the pump

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,

Premenstural, 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.

• Active insulin is bolus insulin that has been given to lower your blood glucose, but has not yet been fully used.

• Active insulin appears only if bolus advice is activated.

• Calculation of the amount of the active insulin is completed automatically by the meter. If necessary, the meter rounds the active insulin amount.

• If the active insulin amount is calculated as zero, then the value is displayed as 0.

• If active insulin data is not found, then active insulin value is displayed as “---U.”

• If Bolus is selected, then the Connecting to the Pump screen appears before the Bolus Advice screen is displayed.

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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?

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

Read Chapter 2, Testing Your Blood Glucose, and repeat the blood glucose test. If you still have problems, contact

ACCU-CHEK Customer Care Service Center at

1-800-688-4578.

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Troubleshooting Checks

6. Are the meter and test strips working properly?

7. Are you still unsure of the problem?

Actions

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

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 match 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. These symptoms may include, but are not limited to:

• 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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65

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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

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

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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. The control level is printed on the bottle label.

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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 trips 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.

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 Menu 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 Control Results

Example

Range (mg/dL)

Level 1 25-55

Level 2 255-345 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.

j

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

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

Troubleshooting Checks

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?

Actions

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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Troubleshooting Checks

6. Did you follow the directions?

7. Did you choose 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. If you still have problems, contact

ACCU-CHEK Customer Care Service Center at

1-800-688-4578.

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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95

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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 Combo 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, and bolus). 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.

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

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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 type

• Bolus amount

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

4

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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

bG Test

Meal Time

Carbs

Health Event

Standard Bolus Not Confi rmed

Standard Bolus Confi rmed

Multiwave Bolus Not Confi rmed

Multiwave Bolus Confi rmed

Extended Bolus Not Confi rmed

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4

Description

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.

Delivery has not been confi rmed by the pump.

Delivery has been confi rmed by the pump.

Delivery has not been confi rmed by the pump.

Delivery has been confi rmed by the pump.

Delivery has not been confi rmed by the pump.

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Icon Icon Name

Extended Bolus Confi rmed

Manual Pump

Pen/Syringe Bolus

Description

Delivery has been confi rmed by the pump.

Delivery has not been confi rmed by the pump.

Pump does not deliver bolus.

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

Main Menu > My Data > View Data

4

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:

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

=

.

Press x or z to view other records (the screen scrolls if there are additional records).

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

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4.

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.

5.

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.

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

NOTE

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

Cancel.

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The following fields cannot be modified with the specified condition:

Fields Cannot be modified if the …

Bolus Bolus type is confirmed standard, extended, or multiwave

Bolus Blood glucose test result was below the hypo warning limit

Meal Time

Meal Time, Carbs, Health Event, and Bolus

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, and bolus. The Add Data screen displays the following information:

Time Entry Field

Date Entry Field

Carbs Entry Field

Health Entry Field

Bolus Entry Field

Save

Appears once data has been entered to an entry field

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Main Menu > My Data > Add Data

1.

2.

3.

j From the Main Menu, select

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

4

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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 corrupt results, control results, or HI and LO results.

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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

From the Main Menu, select

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

From the Main Menu, select

My Data and press

=

.

j Select Reports and press = .

j Select Trend and press = .

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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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Follow these tips to get the most value from My Data reports:

• If you delivered a bolus directly on the pump, go to My Data on the meter to receive the bolus information automatically. Do this before your next blood glucose test.

• Replace the batteries when the Low Battery icon appears. This maintains the communication between meter and pump.

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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 corrupt results or 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.

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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).

To return to the Reports screen, select Back.

4

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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.

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Trend Table Screen

Time Range

Meal Time Selection

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

4

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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 corrupt results or 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.

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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

(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.

4

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4.

j

Press

.

to display the Graph

(see previous section for more information).

To return to the Reports screen, select Back.

NOTE

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

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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.

4

j

From the Main Menu, select

My Data and press

=

.

j

Select Reports and press

=

.

j

Select Standard Day and press

=

.

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Standard Day Graph Screen

Time Range

Meal Time Selection

Blood Glucose Unit of Measure

Blood Glucose Icon

Time of Day

Warning Limit Hypo Level

Red horizontal line

Arrow

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

Ending Time of Each Time

Block

Vertical dashed line

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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.

6/11/13 3:58 PM

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 corrupt results, control results, HI values, or LO values.

4

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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

.

to display the Table

(proceed to the next section for more information).

To return to the Reports screen, select Back.

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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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Standard Day Table Screen

Time Range

Meal Time Selection

Time Block

Blood Glucose Average

Standard Deviation (SD)

Number of Tests

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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 corrupt results, control results, or HI and LO results.

• 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.

4

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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

(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.

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4.

j

Press

.

to display the Graph

(see previous section for more information).

To return to the Reports screen, select Back.

NOTE

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

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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.

j

From the Main Menu, select

My Data and press

=

.

j

Select Reports and press

=

.

j Select Standard Week and press = .

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Standard Week Graph Screen

Time Range

Meal Time Selection

Blood Glucose Unit of Measure

Blood Glucose Icon

Day of Week

Warning Limit Hypo Level

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.

4

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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 corrupt results, control results, HI values, or LO values.

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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

> until you reach the time range you need.

2.

j

To display a standard week 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).

To return to the Reports screen, select Back.

4

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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.

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Standard Week Table Screen

Time Range

Meal Time Selection

Day of Week

Blood Glucose Average

Standard Deviation (SD)

Number of Tests

4

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 corrupt results, control results, or HI and LO results.

• 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, 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.

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4.

j

Press

.

to display the Graph

(see previous section for more information).

To return to the Reports screen, select Back.

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 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.

j

From the Main Menu, select

My Data and press

=

.

j Select Reports and press = .

j

Select Target and press

=

.

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Target Graph Screen

Time Range

Legend

Blood glucose test result categories

Meal Time Selection

Pie Chart

Represents the percentages for the blood glucose test result categories

4

NOTE

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

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

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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

(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).

To return to the Reports screen, select Back.

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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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Target Table Screen

Time Range

Legend

Blood glucose test result categories

Meal Time Selection

Percentage of Occurrence

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 corrupt results, control results, or HI and LO results.

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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

> until you reach the time range you need.

2.

j

To display a target table 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 Target

Graph (see previous section for more information).

To return to the Reports screen, select Back.

4

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NOTE

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

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4.5 Downloading Your Data to a Computer

You can transfer your stored results to a computer to track, identify patterns, and print.

1.

j

Install the software according to the instructions.

j Connect the computer cable according to the instructions.

2.

j

Run the software program and follow the instructions about how to download information.

Ensure the software is ready to accept data from the meter.

3.

j

From the Main Menu, select

My Data and press = .

4

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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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7.

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, Other

5.4 Setting Date Reminders: Dr. Visit, Lab Test, Infusion Set Change

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

5.11 Turning Bluetooth

®

Wireless Technology On or Off

5.12 Pairing the Meter and Pump

5.13 Setting the Beeper, Vibrate, Key Sound

5.14 Setting the Time Format, Time, Date

5.15 Setting Time Blocks: Bolus Advice Not Set Up

5.16 Backlight Settings

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185

188

191

199

176

179

182

184

152

161

170

173

138

139

144

147

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5.1 Overview

You have the flexibility to change the ACCU-CHEK Aviva Combo 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.

• If you change the pump time and date, the meter time and date will automatically synchronize to match the pump.

NOTE

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

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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.

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

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Main Menu > Settings > Reminders > bG Test Reminders

1.

2.

3.

j

From the Main Menu, select

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.

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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

=

.

To Change the Remind After

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 Select the Reminder entry field and press = . j

Select On or Off and press

=

.

To Change the Snack Size:

j

Select the Snack Size entry field and press

=

.

j

Set the Snack Size amount and press = .

To Change the Remind After

Time:

j Select the Remind After entry field and press = .

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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.

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, 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

• 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 for an Alarm Clock bG Test Reminder), the reminder is displayed when the meter powers down.

• Alarm Clock bG Test: Dismiss the reminder by pressing

.

. Reschedule (snooze) the reminder for

15 minutes by pressing , .

• Alarm Clock Other: Dismiss the reminder either by pressing

.

or by inserting a test strip.

Reschedule (snooze) the reminder for 15 minutes by pressing

,

.

• 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 Alarm Clock bG Test reminders which are pending within the next 30 minutes.

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

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Main Menu > Settings > Reminders > Alarm Clock

1.

2.

3.

j From the Main Menu, select

Settings and press = .

j Select Reminders and press

= .

j Select Alarm Clock and press

=

.

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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 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 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.

• Exposure to extreme cold conditions may disable

Alarm Clock reminders until the meter is turned on.

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5.4 Setting Date Reminders: Dr. Visit, Lab Test, Infusion Set

Change

Date reminders are a helpful way to remind you of an upcoming Dr. visit or lab test. In addition, you can set up an ongoing reminder for an infusion set change for the interval you choose (1 day, 2 days, or 3 days).

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.

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

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Main Menu > Settings > Reminders > Date Reminders

1.

2.

3.

j

From the Main Menu, select

Settings and press

=

.

j

Select Reminders and press

=

.

j

Select Date Reminders and press = .

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4.

j

Select either Dr. Visit, Lab Test, or Infusion Set Change and press = .

j Proceed to either Dr. Visit, Lab

Test, or Infusion Set Change in this step.

To Turn the Dr. Visit Reminder

On or Off:

j Select the Reminder entry field and press = . j

Select On or Off and press

=

.

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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To Turn the Lab Test

Reminder On or Off:

j Select the Reminder entry field and press = . j

Select On or Off and press

=

.

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.

To Turn the Infusion Set

Change Reminder On or Off:

j Select the Reminder entry field and press = . j

Select On or Off and press

=

.

To Set the Interval:

j Select the Interval entry field and press

=

. j

Select the Interval (1 day,

2 days, or 3 days) and press = .

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

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.

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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.

j

From the Main Menu, select

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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5

4.

5.

j

To continue, select Next.

To Change Time Blocks:

j

Select a time block to edit and press = .

scroll down

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To Change the End Time:

j

Select the End Time entry field and press = .

j Set the End Time and press

=

.

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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 = .

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

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

Set the number of Insulin Units and press

=

.

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.

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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

Select the End Time entry field and press

=

.

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.

To Remove a Time Block:

j

Select the Time Block you want to remove and press = .

5

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8.

9.

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

=

.

j

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

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

=

.

To Change the Snack Size:

j Select the Snack Size entry field and press

=

.

j

Set the Snack Size amount and press

=

.

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 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.

5

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Setting Time Blocks–Bolus Advice is Set Up

Main Menu > Settings > Bolus Advice > Time Blocks

1.

2.

3.

j

From the Main Menu, select

Settings and press

=

.

j

Select Bolus Advice and press

=

.

j

Select Time Blocks and press

=

.

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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

Select the End Time entry field and press

=

.

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 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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5.

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 = .

To Change the End Time:

j

Select the End Time entry field and press = . j Set the End Time and press

=

.

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

=

.

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 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 selected units of insulin and press

=

.

To Change the Insulin

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

=

.

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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

From the Main Menu, select

Settings and press

=

.

j

Select Bolus Advice and press

=

.

j

Select Health Events and press

= .

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5

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

From the Main Menu, select

Settings and press

=

.

j

Select Bolus Advice and press

=

.

j

Select Advice Options and press

=

.

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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

=

.

To Change the Snack Size:

j

Select the Snack Size entry field and press

=

.

j

Set the Snack Size amount and press = .

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

From the Main Menu, select

Settings and press = .

j

Select Meter and press

=

.

j

Select Warning Limits and press

=

.

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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

From the Main Menu, select

Settings and press = .

j

Select Meter and press

=

.

j

Select Key Lock and press

=

.

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5

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

• The meter is turned on and a pump error or a pump warning occurs

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.

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Main Menu > Settings > Meter > Language

1.

2.

3.

j

From the Main Menu, select

Settings and press = .

j

Select Meter and press

=

.

j

Select Language and press

=

.

5

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4.

j

Press

=

to display the

Language options.

j Select the desired Language and press = .

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

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5.10 Setting Units: Carbs

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

Units are set and bolus advice is activated, the Carbs Units cannot be changed.

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Main Menu > Settings > Meter > Units

1.

2.

3.

j

From the Main Menu, select

Settings and press = .

j

Select Meter and press

=

.

j

Select Units and press

=

.

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4.

j

Press

=

to display the list of units for carbs.

j Select the units (Grams, BE,

KE, or CC) and press = .

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

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 Turning Bluetooth

®

Wireless Technology On or Off

Main Menu > Settings > Meter > Bluetooth

1.

2.

3.

j From the Main Menu, select

Settings and press = .

j Select Meter and press = .

j

Select Bluetooth and press

=

.

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5

4.

j

To turn Bluetooth wireless technology either On or Off, press and hold * until the

Bluetooth wireless technology icon changes. Release

*

.

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

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5.12 Pairing the Meter and Pump

For complete pairing instructions, see the Advanced Owner’s Booklet.

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5.13 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.

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Main Menu > Settings > Sound/Vibrate

1.

2.

3.

j

From the Main Menu, select

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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5.14 Setting the Time Format, Time, Date

NOTE

• It is recommended you set the date and time on the pump (the date and time on the meter will automatically synchronize to match the pump).

• 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

From the Main Menu, select

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 = .

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To Change the Time:

j

Select the Time entry field and press = .

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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5.15 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.

5

Target Range Lower Value Time Block End Time

Target Range Upper Value

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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.

j From the Main Menu, select

Settings and press

=

.

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.

To Change the End Time:

j Select the End Time entry field and press

=

.

j

Set the End Time and press

=

.

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 = .

j Set the value 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.

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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

Main Menu > Settings > Time Blocks

1.

2.

3.

j

From the Main Menu, select

Settings and press

=

.

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

j Select Time Blocks and press

=

.

j

Select the last time block and press

=

.

5

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4.

j

Select the End Time entry field and press

=

.

j

Set the End Time of the selected Time Block and press

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

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

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

Main Menu > Settings > Time Blocks

1.

2.

3.

j

From the Main Menu, select

Settings and press = .

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

j Select Time Blocks and press

=

.

j

Select the Time Block you want to remove and press = .

5

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4.

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

=

.

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

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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5.16 Backlight Settings

The backlight on your ACCU-CHEK Aviva Combo 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.

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Backlight Button

Press to adjust the backlight level.

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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

202

203

205

206

216

222

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

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

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6

6.2 List of Icons

The icons and icon names in the meter are:

Icon Name

Active Insulin

Icon

Add Data

Analyzing

Beeper

Blood Glucose Averages

Blood Glucose Test

Bluetooth Wireless Technology Enabled

Bolus Advice

Bolus Advice (Settings)

Carbs

Icon Name

Control Test

Date

Download (Data Transfer)

Error

Extended Bolus Confi rmed

Extended Bolus Not Confi rmed

Health

Low Battery

Meal Time

Meter

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Icon

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Icon Name

Meter (Settings)

Multiwave Bolus Not Confi rmed

Multiwave Bolus Confi rmed

My Data

Pen/Syringe Bolus

Pump

Reminder

Reminders (Settings)

Reports

Settings

Icon Icon Name

Sound/Vibrate (Settings)

Standard Bolus Confi rmed

Standard Bolus Not Confi rmed

Time

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, 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.

bG Test It is time for your scheduled bG test

Dr. Visit Today

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 Dismiss

Dismiss

15 minutes

6

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Reminder Title Reminder Message

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 High bG Result on last test.

Retest.

Left Soft Key Right Soft Key Snooze Time

Snooze

Infusion Set Change It is time to change your Infusion

Set

Snooze

Dismiss

Dismiss

Dismiss

15 minutes

Displayed the next time the meter is powered-on

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Reminder Title Reminder Message

Lab Test Today

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

Left Soft Key Right Soft Key Snooze Time

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

Low bG Retest

Other

Low bG Result on last test.

Retest.

Snooze

It is time for your Other activity Snooze

Dismiss

Dismiss

Dismiss

Dismiss

5 minutes

15 minutes

1

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

6

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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 and Other)

3. Date Reminders (Dr. Visit, Lab Test, and Infusion Set Change)

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 .

or by inserting a test strip.

Infusion Set Change Reminder

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

• Dismiss the reminder by pressing

.

.

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

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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.

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

• 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.

• Dismiss the reminder by pressing

.

.

• 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.

6

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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.

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

• 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.

• Dismiss the reminder by pressing .

.

• Snooze the reminder for 15 minutes either by pressing

,

or by inserting a test strip.

• 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)

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

• 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.

• Dismiss the reminder by pressing

.

.

• 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 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 and Other

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

• 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

• 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 all active bG Test reminders by pressing

.

.

• Snooze the reminder for 15 minutes either by pressing

,

or by inserting a test strip.

• 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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• 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

.

or by inserting a test strip.

• Snooze the reminder for 15 minutes by pressing , .

6

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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

Bolus Advice Bolus Advice data deleted

Left Soft Key Right Soft Key

OK

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 Delivery Unavailable Communication lost. Retry or set to Manual

Pump.

Bolus Delivery Unavailable Pump unable to start Bolus. See Pump.

Bolus Delivery Unavailable Pump currently in Stop mode

OK

OK

OK

OK

6

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Warning Title

Bolus Too High

Warning Message

Bolus above allowed amount. Bolus set to maximum.

Bolus Too Low Bolus below allowed amount. Bolus set to minimum.

Calculation Out of Range No Bolus Advice available

Left Soft Key Right Soft Key

OK

OK

Carbohydrate Ratio

Code Key Missing

Carb Ratio seems unusual. Check entries.

Turn off Meter and insert valid Code Key

Communication Lost See Pump

Communication Warning Pump data not available, Active Insulin may not be accurate

Communication Warning Pump data not available, recent Bolus data may not be accurate

Connection Lost Ensure Pump is within range of Meter

Connection Lost

Corrupt Language

Restart Meter, select “Settings”, “Meter”,

“Pair with Pump”

Choose another language

OK

OK

OK

OK

OK

OK

OK

OK

OK

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6

Warning Title

Diary Entry Used For

Advice

Diary Results Expired

Warning Message

Diary entry used for Advice, modifications not allowed

New data cannot be saved with this record

Left Soft Key Right Soft Key

OK

OK

HI bG Warning Consider checking bG, ketones and insulin

Incorrect Pump Time/Date Pump time/date incorrect. Set time/date on the Pump.

2

Infrequent Pump

Communication

Two weeks since last communication with

Pump

Insulin Sensitivity

Invalid Active Insulin

Insulin Sensitivity seems unusual. Check entries.

Unable to calculate the Active Insulin. Bolus

Advice not available.

Invalid Bolus Advice

Times

Invalid Date

Acting time must be greater than or equal to offset time

Reenter valid date

Invalid Hyper Values Hyper value must be greater than Time

Block target ranges

OK

OK

OK

OK

OK

OK

OK

OK

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Warning Title

Invalid Hypo Values

Warning Message

Hypo value must be less than Time Block target ranges

Reenter PIN shown on Pump display Invalid PIN

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

Invalid Target Range Lower target range value above upper target range value

Invalid Target Range

LO bG Warning

Range selected conflicts with Hyper and/or

Hypo Warning Limit settings

Retest bG. Contact your doctor.

Left Soft Key Right Soft Key

OK

OK

OK

OK

OK

OK

Pair with Pump to use this feature OK Meter and Pump Not

Paired

Meter Battery Low

No bG with Bolus

Pairing Failed

Replace soon. No Pump connection.

Consider testing bG before delivering

Insulin. Continue?

Restart Meter, select “Settings”, “Meter”,

“Pair with Pump”

No

OK

Yes

OK

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Warning Title

Pump Not Available

Warning Message

Ensure Bluetooth is on and Pump is within range of Meter

Change Code Key and Strips soon

Left Soft Key Right Soft Key

OK

OK Test Strips Expiring

Time Mismatch Meter time has been changed by more than

5 minutes to match Pump

1

The meter displays a recommended amount of fast carbohydrates.

2 The meter keeps its current date and time. The meter turns off Bluetooth wireless technology communication for this session.

OK

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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.

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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

Retest with new Strip

Turn Meter off, replace Code Key and Strips

Retest with new Strip

Remove batteries, wait 20 seconds, replace batteries

Move Meter to correct temperature and wait 5 minutes

Left Soft Key Right Soft Key

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

Left Soft Key Right Soft Key

Menu

1

“Menu” is only displayed when the meter is on 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

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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.

• Disinfect the meter and lancing device before allowing anyone else to handle them. Do not allow anyone else to test with the meter or lancing device.

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

• 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

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

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 to remove visible dirt or other material prior to disinfecting.

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

• Clean and disinfect the meter before allowing anyone else to handle 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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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 will damage the meter and stop it from working properly.

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7

1.

2.

3.

j

Wash hands thoroughly with soap and 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 slot or 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.

NOTE

Roche has tested the approved product for a total of 416 cycles, which is equal to cleaning and disinfecting once per week for a 4 year period.

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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 to remove visible dirt or other material prior to disinfecting.

• Clean and disinfect the lancing device once per week to remove visible dirt or other material for safe handling.

• Clean and disinfect the lancing device before allowing anyone else to handle the lancing device, for instance, if you have someone assisting you.

Do not allow anyone else to use the lancing device.

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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

Wash hands thoroughly with soap and water.

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.

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.

j

Wash hands thoroughly with soap and water.

NOTE

Roche has tested the approved product for a total of 520 cycles, which is equal to cleaning and disinfecting once per week for a

5-year period.

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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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8.1 Overview

It is important to properly care for and maintain your ACCU-CHEK Aviva Combo 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.

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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.

• The meter remains paired with the pump when you remove and replace the batteries.

• 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:

Bluetooth wireless technology communication is disabled.

• 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.

• 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.

• 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 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 Combo Meter

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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

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

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

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9.2 Troubleshooting the ACCU-CHEK Aviva Combo 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.

Bluetooth icon fl ashing

Possible Solution(s)

j

Install new batteries. See Chapter 8, Maintenance.

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

j Communication ended due to a button press on the pump.

j

Meter is defective.

Meter and pump are outside of communication range.

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 fi ve minutes before turning on the meter. Do not artifi cially heat or cool the meter.

j Check the pump and continue operation of the pump manually.

j

Ensure the pump has Bluetooth wireless technology turned on.

j

Ensure pump is within communication range.

9

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Display Shows Possible Cause(s)

Above Hyper

Warning Limit j

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

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

Below Hypo

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

Possible Solution(s)

j

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

j Consider checking bG, ketones, and insulin.

j

See the pump User Guide for additional solutions.

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

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.

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Display Shows Possible Cause(s)

Bolus Advice

Bolus Advice data deleted j

Bolus advice data integrity cannot be confirmed.

Bolus Advice Not

Setup

Possible Solution(s)

j

Wait 8 hours for accurate bolus advice.

IMPORTANT

• Insulin doses and meals taken before the Bolus Advice warning are no longer reflected in the bolus advice calculation.

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

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.

j

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

9

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Display Shows Possible Cause(s)

Bolus Delivery

Unavailable

Bolus Too High

Bolus Too Low

Possible Solution(s)

j

The meter cannot communicate with the pump.

j

Retry or set to Manual Pump.

j Ensure the meter and pump have Bluetooth wireless technology turned on.

j

Ensure the meter and pump are within communication range.

j

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

j

Take the pump out of Stop mode.

j

The pump is currently in Stop mode.

j

The pump is currently delivering a bolus.

j

The bolus is above the allowed amount. The bolus was set to 50 Units.

j

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

j

Check the accuracy of all entries. If necessary, contact your healthcare professional.

j

The insulin pump cannot deliver a 0.1 Unit of multiwave bolus.

j

The pump will adjust the bolus to 0.2 Units.

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Display Shows Possible Cause(s)

Carbohydrate Ratio j

Carbohydrate ratio is outside of the acceptable meter range.

Code Key Missing j

The black code key is not inserted.

Communication

Lost j Pump is out of range of the meter.

Possible Solution(s)

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

1-800-688-4578.

j Bolus delivery continuing, see pump screen.

j

Ensure the meter and pump have Bluetooth wireless technology turned on.

j

Ensure the meter and pump are within communication range.

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

j

Use the pump to monitor or cancel a bolus which is in the process of being delivered.

9

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Display Shows Possible Cause(s)

Communication

Warning

Possible Solution(s)

j

Communication of bolus data from the pump was not successful. Therefore, pump data are not available and the bolus data may not be accurate.

j Communication of bolus data from the pump was not successful. Therefore, pump data are not available and the active insulin amount may not be accurate.

j

Ensure the meter and pump have Bluetooth wireless technology turned on.

j Ensure the meter and pump are within communication range.

j

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

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Display Shows Possible Cause(s)

Connection Lost j

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

j

Pump is out of range of the meter.

Possible Solution(s)

j

Restart the pairing process. See the Advanced

Owner’s Booklet.

j Ensure the meter and pump have Bluetooth wireless technology turned on.

j

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

j

Ensure the meter and pump are within communication range.

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.

9

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Display Shows Possible Cause(s)

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.

Possible Solution(s)

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

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

j Please contact ACCU-CHEK Customer Care Service

Center at 1-800-688-4578.

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Display Shows Possible Cause(s)

E-53 Bad Test

Error

Possible Solution(s)

j

A meter or test strip error has occurred.

j

Your blood glucose may be extremely high.

j

Discard the test strip and repeat the test.

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.

9

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Display Shows Possible Cause(s)

E-54 Not Enough

Sample

E-55 Code Key

Expired

E-56 Sample

Applied Early

Possible Solution(s)

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

ACCU-CHEK Customer Care Service Center at

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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Display Shows Possible Cause(s)

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.

Possible Solution(s)

j

Turn off the meter and remove the batteries. Wait at least 30 seconds prior to reinserting the batteries.

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

ACCU-CHEK Customer Care Service Center at

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.

9

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Display Shows Possible Cause(s)

HI bG Warning j

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

Possible Solution(s)

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.

j See the pump User Guide for additional solutions.

j

Set time/date on the pump (see pump User Guide).

Incorrect Pump

Time/Date

Infrequent Pump

Communication j

Pump time/date incorrect.

j

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

j

Ensure the meter and pump have Bluetooth wireless technology turned on.

j Ensure the meter and pump are within communication range.

j

If the low battery icon is displayed on the meter, the meter cannot communicate with the pump. Replace the batteries. j It is important to use Bluetooth wireless technology communication between the meter and pump regularly if you utilize bolus advice.

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9

Display Shows Possible Cause(s)

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

Invalid Bolus

Advice Times j

The acting time value is less than the offset time.

Possible Solution(s)

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

Invalid Date

Invalid Hyper

Values

Invalid Hypo Values 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 hypo warning limit value must be less 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.

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.

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Display Shows Possible Cause(s)

Invalid PIN

Invalid Record

Time/Date

Invalid Target

Range

LO bG Warning

Possible Solution(s)

j

The wrong PIN was entered.

j

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

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 j

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

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

j j

Reset the target range values.

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.

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.

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Display Shows Possible Cause(s)

Meter and Pump

Not Paired j

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

Meter Battery Low j Battery power is low.

Possible Solution(s)

j

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

j For instructions on how to pair the meter and pump, see the Advanced Owner’s Booklet.

j Install new batteries. See Chapter 8, Maintenance.

9

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

Pairing Failed j

The attempt to pair the meter and pump was unsuccessful.

j It is recommended to test bG before delivering insulin.

j

Restart the pairing process. See the Advanced

Owner’s Booklet.

Pump Not Available j

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

j

Ensure the meter and pump have Bluetooth wireless technology turned on.

j Ensure the meter and pump are within communication range.

j

If the low battery icon is displayed, the meter cannot communicate with the pump. Replace the batteries.

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

Test Strips Expiring

Time Mismatch 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

ACCU-CHEK Customer Care Service Center at

1-800-688-4578.

j

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

Settings.

j

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

j

The meter time and date were changed to match the pump time. Ensure the time and date are correct. If the time or date are not correct, change the time and date on the pump.

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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

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267

268

270

273

275

282

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

Power supply

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Refer to the test strip package insert.

Fresh whole blood

Refer to the test strip package insert.

Refer to the test strip package insert.

Refer to the test strip package insert.

-4 °F to 122 °F

Refer to the test strip package insert.

Refer to the test strip package insert.

1,000 diary records

2 minutes

Three AAA batteries (recommended: alkaline)

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Display

Dimensions

Weight

Construction

Protection class

Meter type

Control solution storage conditions

Interface

LCD

3.7 x 2.1 x 1 inches (LWH)

Approximately 3.6 oz with batteries inserted

Hand-held

III

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

36 °F to 90 °F

IR; LED/IRED – Class 1

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270

10.4 Product Safety Information

WARNING

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

Bluetooth Wireless Technology

The meter and the pump utilize Bluetooth wireless technology to communicate and transfer information.

Bluetooth wireless technology is a form of radio frequency (RF) technology that operates in the unlicensed industrial, scientific, and medical band at 2.4 to 2.485 GHz. The RF channel utilized for communication between the meter and the pump is not an open channel. The meter can only communicate with the pump it is paired with; therefore, other Bluetooth wireless technology devices (e.g., cell phone, printer, etc.) cannot be paired with, communicate with, or access your personal information on the meter or the pump.

Radio Frequency Communication

FCC ID: WX3-361

The device complies with the United States Federal Communications Commission (FCC) standards. The device complies with FCC Part 15 Rules. Operation of the device is subject to the following two conditions:

(1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Compliance with these guidelines means that under normal, daily circumstances the device should not affect the operation of other devices. In addition, the device should operate normally in the presence of other devices.

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In the event there is interference from another device, it is recommended that you increase distance between meter and that device. You may also turn off the interfering device. In addition, you may turn off Bluetooth wireless technology on the meter and deliver insulin directly using the pump.

Changes or modifications to the device not expressly approved by Roche could void the user’s authority to operate the device.

The device has been tested and found to comply with the limits for a Class B digital device. The device generates, uses, and can radiate radio frequency energy.

This equipment complies with FCC and IC radiation exposure limits set forth for an uncontrolled environment.

This equipment is in direct contact with the body of the user under normal operating conditions. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter.

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 the meter to other electrically driven equipment is not to be anticipated.

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Performance Analysis

The ACCU-CHEK Aviva Combo system (ACCU-CHEK Aviva Combo 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.

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.

• 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.

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• 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 Combo Meter Limited 4-Year Warranty

Roche Health Solutions Inc. (“Roche”), a member of the Roche Group, warrants to the original purchaser of the meter that your ACCU-CHEK Aviva Combo meter will be free from defects in materials and workmanship for 4 years from the date of purchase. If during this 4-year period, the meter does not work properly because of a defect in materials or workmanship, Roche will replace it with a new ACCU-CHEK Aviva Combo 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 Combo meter shall be replacement.

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

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THE PRECEDING WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE 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 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 Instructions

All requests for return of ACCU-CHEK Aviva Combo meters under the preceding warranty 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. 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 Combo system.

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Limited License

CAUTION

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

LIMITATIONS RECITED BELOW.

The ACCU-CHEK Aviva Combo system (meter, including the code key, and test strips) and its use are protected by U.S. Patent Nos. 6,645,368 (expires 22-December-2017); 7,276,146 (expires 4-October-2022); 7,276,147

(expires 4-October-2022); 7,407,811 (expires 9-May-2020); 7,452,457 (expires 2-May-2026); 7,488,601

(expires 1-February-2026); 7,494,816 (expires 29-December-2019); 7,569,126 (expires 28-December-2026);

7,604,721 (expires 12-August-2026); 8,298,401 (expires 4-October-2022); 8,303,801 (expires

4-October-2022); and 8,329,026 (expires 4-October-2022). A license to use the ACCU-CHEK Aviva Combo system is required until the expiration of the last-to-expire patent listed above and is only granted when the

ACCU-CHEK Aviva Combo meter is used with the ACCU-CHEK Aviva Plus test strips and ACCU-CHEK Aviva Plus code keys.

ACCU-CHEK Aviva Plus test strips are provided with a specifically matched ACCU-CHEK Aviva Plus code key.

These test strips and code keys are specifically manufactured for operation with the ACCU-CHEK Aviva Combo meter. Use of other test strips with an unmatched code key or even with the matched code key supplied by another manufacturer may prevent or impair the proper function of the ACCU-CHEK Aviva Combo system.

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Using the ACCU-CHEK Aviva Combo system indicates your acceptance of the restricted license to use the ACCU-CHEK Aviva Combo system only with ACCU-CHEK Aviva Plus test strips and the corresponding

ACCU-CHEK Aviva Plus code key. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused ACCU-CHEK Aviva Combo system for a full refund. If you have any questions, please call the ACCU-CHEK Customer Care Services Center at 1-800-688-4578.

Except where prohibited by statute, all warranties covering the ACCU-CHEK Aviva Combo system are voided by use of the ACCU-CHEK Aviva Combo system with any test strips or code keys other than ACCU-CHEK

Aviva Plus test strips or code keys.

Patent Information

U.S. Pat.:http://www.roche-diagnostics.us/patents

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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 expiration of the last-to-expire patent listed above and is only granted when ACCU-CHEK FastClix lancet drums are used with the ACCU-CHEK FastClix device.

ACCU-CHEK FastClix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the ACCU-CHEK FastClix device. Use of other lancet drums with the

ACCU-CHEK FastClix device may prevent or impair proper function of the ACCU-CHEK FastClix device.

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Using the ACCU-CHEK FastClix device indicates your acceptance of the restricted license to use the

ACCU-CHEK FastClix device only with ACCU-CHEK FastClix lancet drums. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused ACCU-CHEK FastClix device for a full refund. If you have any questions, please call the ACCU-CHEK Customer Care Services Center at 1-800-688-4578.

Except where prohibited by statute, all warranties covering the ACCU-CHEK FastClix device are voided by use of the ACCU-CHEK FastClix device with any lancet drums other than ACCU-CHEK FastClix lancet drums.

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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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°F

FCC g

GHz

BE bG

Carbs

CC

Hyper

Hypo

Appendices

Appendix A: Abbreviations

Abbreviation

AM

Definition

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

Bread Equivalent (equal to 12 grams of carbohydrates)

Blood Glucose

Carbohydrates

Carbohydrate Choice (equal to 15 grams of carbohydrates)

Degrees Fahrenheit

Federal Communications Commission (United States)

Grams

Gigahertz

Hyperglycemia (high blood glucose)

Hypoglycemia (low blood glucose)

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Abbreviation

IR

RF

SD

U

N/A

NIST

PIN

PM

ISO

KE

LCD mg/dL

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Definition

Infrared

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)

Personal Identification Number

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

Radio Frequency

Standard Deviation

Units (bolus 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

BE

Kohlenhydrateinheit

Bread Equivalent

CC Carbohydrate Choice

*Standard unit of measure in the U.S.

10 grams

12 grams

15 grams

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Appendix C: Explanation of Symbols

You may encounter the following symbols on the packaging, on the type plate (back of meter), and in the instructions for the ACCU-CHEK Aviva Combo meter, shown here with their meaning.

w

Caution, refer to safety-related notes in the instructions for use accompanying this product.

Federal law (USA) restricts this device to sale by or on the order of a physician per

21 CFR 801.109.*

1.5V AAA

* Code of Federal Regulations

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Appendix D: Meter Settings and Range Limits mg/dL

Data Type

Acting Time

Unit of Measurement MIN MAX Increments Default Setting

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

Active Insulin Units bG Threshold (High) mg/dL bG Threshold (Low) mg/dL

Carb Ratio (carbs) grams

BE

KE

CC

Carb Ratio (insulin) Units

Carbohydrates grams

BE

KE

CC

0

120

50

1

0.1

0.1

0.1

0.1

0

0

0

0

99.9

0.1

350 1

100 1

240

20

24

16

50

240

20

24

16

1

0.1

0.1

0.1

1

0.1

0.1

0.1

0.1

N/A

Hyper Warning Limit

Hypo Warning Limit

No entry (“--- g”)

No entry (“--- BE”)

No entry (“--- KE”)

No entry (“--- CC”)

1

No entry (“--- g”)

No entry (“--- BE”)

No entry (“--- KE”)

No entry (“--- CC”)

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Data Type

Exercise 1 (health event)

Unit of Measurement MIN

%

Exercise 2 (health event)

Extended Bolus

(insulin)

%

Units

Hyper Warning Limit mg/dL

-50

-50

0

180

MAX Increments Default Setting

50

50

50

1

1

1

0.1

350 1

0

0

N/A

300

Hypo Warning Limit mg/dL 50 90 1 70

Illness (health event) %

Insulin Sensitivity

(bG)

Insulin Sensitivity

(insulin)

Meal Rise (bG)

Multiwave Bolus

(insulin) mg/dL

Units mg/dL

Units

-50

1

0.1

50

0.2

50 1

999 1

50 0.1

200 1

50

1

0.1

0

No entry (“---mg/dL”)

1

50

N/A

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Data Type

Offset Time

Unit of Measurement MIN MAX Increments Default Setting

hours:minutes 0:45 Acting

Time

0:15 1:00

-50 50 1 0 Premenstrual

(health event)

%

Snack Size (carbs) grams

BE

KE

CC

Standard Bolus

(insulin)

Units

Stress (health event) %

0

0

0

0

0

-50

24

2

2.4

1.6

50

1

50

1

0.1

0.1

0.1

0.1

1

No entry (“--- g”)

No entry (“--- BE”)

No entry (“--- KE”)

No entry (“--- CC”)

N/A

0

Target Range Upper

Value

Target Range Lower

Value mg/dL mg/dL

100

50

300

140

1

1

140

70

1

The maximum that can actually be delivered may be less due to the ACCU-CHEK Spirit Combo pump’s maximum insulin amount.

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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

2

Default Time of Day

7:00 am

9:00 am

3

4

5

6

7

8

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

12-Hour Format

12:00 am–5:30 am

4

5

2

3

5:30 am–11:00 am

11:00 am–5:00 pm

5:00 pm–9:30 pm

9:30 pm–12:00 am

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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.”

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Glossary

Term

7-day average

Acting Time

Active Insulin

Advice Options

After High bG Reminder

After Low bG Reminder

After Meal Reminder

Alarm

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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.

Bolus insulin that has been given to lower your blood glucose but has not yet been fully used.

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

bG Test Reminders bG Threshold

Definition

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.

Blood Glucose (bG)

Bluetooth Wireless Technology

Wireless short-range communications technology which connects devices (such as meter and pump) in order to exchange information.

Bolus

Bolus Advice

Bolus Advice Options

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.

Bolus Delivery Start Delay The Standard Bolus icon blinks for five seconds and then the meter communicates to the pump to begin delivery of the bolus amount. During this delay you are able to cancel the bolus delivery by pressing x or z .

The meter beeps and returns to the Pump Run screen.

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Term

Carb Ratio

Carbohydrates (or Carbs)

Control Result

Control Test

Corrupt Result

Current Date

Current Time

Day

End Time

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Definition

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.

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.

bG test result that had an error.

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.

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Term

Extended Bolus

Health Events

HI

Hyper

Hyper Warning Limit

Hypo

Hypo Warning Limit

Insulin Pump

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Definition

A bolus delivered over a period of time. It might be helpful during long meals or when you have meals that are digested slowly. The Extended

Bolus may also be appropriate for people who have gastroparesis

(delayed digestion). This option is available only when Bluetooth wireless technology is turned on and the meter and pump are communicating.

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.

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.

A device that delivers a continuous supply of insulin into the body.

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Term

Insulin Sensitivity

Ketones

Key Lock

LO

Meal Rise

Meal Time

Meter

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Definition

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.

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

During or after meals, an increase in blood glucose levels is considered normal within a certain range, even through 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.

During or after meals, an increase in blood glucose levels is considered normal within a certain range, even though a meal bolus has been delivered.

Blood glucose meter.

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Term

Multiwave Bolus

Note

Offset Time

Paired

Pump

Quick Bolus

Remind After

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Definition

A bolus designed to better simulate the body’s insulin delivery. It combines an immediate bolus delivery followed by an Extended Bolus delivery. A Multiwave Bolus can be helpful when you have meals that include both rapidly and slowly absorbed carbohydrates. This option is available only when Bluetooth wireless technology is turned on and the meter and pump are communicating.

Additional information.

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 pump and meter exclusively communicating and transferring information with each other.

See Insulin Pump.

A bolus delivery on the pump using the pump UP and DOWN keys. One key press equals one bolus increment (i.e., 0.1, 0.2, 0.5, 1.0, 2.0). See the pump User Guide for more information.

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.

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Term

Reminder

Snack Size

Snooze

Soft Keys

Standard Bolus

Standard Deviation

Start Time

Target Range

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Definition

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.).

A bolus that is immediately delivered to cover a food or a blood glucose correction. When Standard is selected, the bolus is delivered by the pump. This option is available only when Bluetooth wireless technology is turned on and the meter and pump are communicating.

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).

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.

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Term

Time Blocks

Time Range

User

Warning

Warning Limits

Definition

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 or pump.

Describes items and conditions that present hazards and may cause personal injury.

See Hyper Warning Limit or Hypo Warning Limit.

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Index

A

abbreviations, 283–285 acting time, 158–160 , 169 active insulin, 51–54 advice options, 168–169 after high bG test reminder, 139–143 , 206 , 208 ,

210 after low bG test reminder, 139–143 , 206 ,

209–210 after meal bG test reminder, 139–143 , 206–

207 , 210 , 213 alarm clock reminders, bG test, 29 , 144–146 , 210 , 214 other, 29 , 144–146 , 210 , 214–215 appetite, increased, 61

B

backlight, button, 13 , 17–18 display, 20 settings, 199–200 batteries, 14 changing, 239–241 low, 31 type, 239 , 241

BE, 179–181 , 285 beeper, settings, 31 , 185–187 bG threshold, 141–142 blood glucose averages, 97–98 blood glucose test, features, 21 performing, 43–51 reminder, 28 , 206 , 290 results, 48 , 51–60 unusual results, 55–60

Bluetooth wireless technology,

communication, 270–271 turning on or off, 17 , 32 , 182–183 blurred vision, 61 bolus advice, 22 , 152–160

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bolus advice options. See advice options bolus, delivery, 23 , 250 buttons, 13 , 15–17 , 16–18

C

carbohydrates, adjustments, 51–54 units of measure, 179–181 , 285 carb ratio, 156 , 251 carbs. See carbohydrates

CC, 179–181 , 285 cleaning, lancing device, 233–235 meter, 228–232 code chip. See code key code key, 15 , 251 , 254 , 256 communication, 247 , 251–253 , 258 control solution, 14 , 66 , 69

302

51638_00048010155_C.indb 302 control test, performing, 65 , 67–72 results, 70–71 , 73–76 results, troubleshooting, 77–78

D

data, adding, 52–54 , 92–94 downloading to a computer, 24 , 133–135 modifying, 83–91 reporting, 95–132 trends, 23 , 99–108 viewing, 83–91 date, reminders, 29 , 147–151 , 210 setting, 188–190 display, 13 , 20 , 247 disposing, meter, 273–274 dr. visit reminder, 147–151 , 207–208 , 210

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E

electromagnetic compatibility, errors, list of,

F

fatigue, 61

222–224 frequent urination, 61

G

g (grams), 179–181 , 285 graph, standard day, 110–113 standard week, 119–122 target, 127–129 trend, 100–104

271 hypo warning limit, 24 , 170–172 , 248 , 259

I

icons, listing, 85–86 , 203–204 infrared (IR) window, 13–14 , 134 infusion set change reminder, 147–151 , 208 ,

210 insulin pump, 19 insulin pump, connecting. See pairing insulin sensitivity, 156 , 259

K

KE, 179–181 key lock, 18 ,

, 285

21 , 173–175 key sound, settings, 185–187

H

headache, 61 health events, 27 , 51–54 , 89 , 93 , 158 , 166–167 high bG retest reminder, 208 , 212 hyper warning limit, 24 , 170–172 , 248 , 259

L

lab test reminder, 147–151 , 209–210 lancing device, 46–47 language, setting, 176–178

303

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lock. See key lock low bG retest reminder, 209–211

M

maintenance, meter, 243 meal rise, 158 , 160 , 169 meal time, 51–54 , 89 meter, settings and range limits, 287–292 summary of features, 13 , 20–29

N

navigation, 36–37 numbness, 61

O

offset time, 159–160 , 169

P

304

51638_00048010155_C.indb 304 pairing, 18 , 184 power button, 13 , 16–18 power-saving tips, 242 pump. See insulin pump

R

rapid heartbeat, 61 reminders, blood glucose test. See blood glucose test, reminder important information, 210–215 list of, 206–209 other, 209 priority, 210

S

safety information, product, 270–272 screen, features, 31 , 34–35 scroll bar, 34 signal settings, 21

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snack size, 142–143 , 158–160 , 169 snooze, 139 , 144 , 205 , 215 soft keys, 13 , 16–18 sound. See beeper, settings specifications, meter, 268–269 standard day, reporting, 109–117 standard deviation, 95–96 standard week, reporting, 118–125 supplies, 282 sweating, 61 symbols, explanation, 286

T

table, standard day, 114–117 standard week, 123–125 target, 130–132 trend, 105–108 target range, 153 , 156 , 164 , 191–193 , 260 target, reporting, 126–133 test results, storing, 81–82 unusual, 59–60 test strip, 254 , 262 thirst, increased, 61 time blocks, 25–26 , 152–165 , 191–198 , 291 time change, data, 100 , 102 , 105–106 time format, setting, 188–189 time, setting, 188–190 tingling, 61 trembling, 61 troubleshooting, 247–263

U

units of measure. See carbohydrates, units of measure unlock. See key lock use by date, 41 , 59 , 66 , 77

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V

vibrate, settings, 185–187

W

warnings, list of, 216–221 warranty, 275–277

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308

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51638_00048010155_C.indb 2

LAST UPDATE: 2012-08

6/11/13 3:57 PM

Aviva Combo

©2013 Roche Diagnostics

Assembled in USA.

Distributed by:

Roche Health Solutions Inc.

11800 Exit 5 Parkway, Suite 120

Fishers, IN 46034

Phone: 1-800-280-7801

Fax: 1-888-810-0758

51638_00048010155_C.indb 1

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

AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and

FASTCLIX are trademarks of Roche.

The Bluetooth

®

word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and product names are the property of their respective owners.

BLOOD GLUCOSE METER

Standard Owner’s Booklet for Self-Testing Only

6/11/13 3:57 PM

Roche USA – 51638

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V6/2 – 00048010155/C – Cyan –

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V6/4 – 00048010155/C – Yellow –

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