Roche Accu-Chek Aviva Combo User manual

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Roche USA – 70949
V4/1 – 05322502001/H – Black
Roche USA – 70949
V4/2 – 05322502001/H – Cyan
Roche USA – 70949
V4/3 – 05322502001/H – Magenta
Roche USA – 70949
V4/4 – 05322502001/H – Yellow
User’s Manual
Accu-Chek®Aviva Combo
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70949_05322502001_H_Cover.indb 2 11/16/2017 12:46:12 PM

This file may not print or view at 100%.
Die lines and color breaks do not print.
“Holding Area” text, box and rules do not
print.
Roche USA – 70949
V4/1 – 05322502001/H – Black
Roche USA – 70949
V4/2 – 05322502001/H – Cyan
Roche USA – 70949
V4/3 – 05322502001/H – Magenta
Roche USA – 70949
V4/4 – 05322502001/H – Yellow
Contents
Introduction ..........................................................................................................................5
Chapter 1: Understanding Your New System ......................................................................7
1.1 Safety Information ............................................................................................................7
1.2 Summary of Features .......................................................................................................7
1.3 The Accu‑Chek Aviva Combo Meter at a Glance ...............................................................9
1.4 Test Strips ......................................................................................................................12
1.5 Screen Content and Navigation.......................................................................................13
1.6 The Accu‑Chek Spirit Combo Insulin Pump at a Glance ..................................................19
Chapter 2: Introduction to Bolus Advice............................................................................21
2.1 Overview .......................................................................................................................21
2.2 Before Using Bolus Advice ..............................................................................................22
Chapter 3: Getting Started .................................................................................................25
3.1 Setup Wizard ..................................................................................................................25
3.2 Setup Wizard: Important Information...............................................................................39
Chapter 4: Testing Your Blood Glucose..............................................................................45
4.1 Before You Start Testing..................................................................................................45
4.2 Performing a Fingertip Blood Glucose Test......................................................................46
4.3 Unusual Blood Glucose Results.......................................................................................52
4.4 Symptoms of Low or High Blood Glucose .......................................................................53
Chapter 5: Control Testing..................................................................................................55
5.1 When to Perform a Control Test ......................................................................................55
5.2 About the Control Solutions ............................................................................................55
5.3 Performing a Control Test ...............................................................................................56
5.4 Out‑of‑Range Control Results .........................................................................................60
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Chapter 6: Administering a Bolus......................................................................................61
6.1 Important Information.....................................................................................................61
6.2 Choosing Your Bolus Type ...............................................................................................62
6.3 Delivering a Bolus...........................................................................................................63
Chapter 7: Programming the Pump Using the Meter........................................................71
7.1 Controlling the Pump with the Meter ..............................................................................71
7.2 Programming a Bolus for the Pump................................................................................76
7.3 Programming a Temporary Basal Rate (TBR) ..................................................................82
7.4 Selecting a Basal Rate Profile.........................................................................................85
7.5 Managing Pump Errors and Warnings.............................................................................87
7.6 Setting a Pump Reminder...............................................................................................89
7.7 Turning the Pump Key Lock On and O ..........................................................................91
7.8 Adjusting the Pump Sound Volume .................................................................................93
7.9 Changing the Pump Signal Settings................................................................................94
Chapter 8: Managing Your Data.........................................................................................95
8.1 Overview ........................................................................................................................95
8.2 Viewing or Modifying Your Data .....................................................................................97
8.3 Adding a Diary Record..................................................................................................102
8.4 Reporting Your Data......................................................................................................104
8.5 Transferring Data to a Computer...................................................................................116
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Chapter 9: Changing Meter Settings................................................................................119
9.1 Overview ......................................................................................................................119
9.2 Setting Up Bolus Advice for the First Time ....................................................................119
9.3 Time Blocks: Bolus Advice Is Set Up .............................................................................126
9.4 Health Event Percentages.............................................................................................129
9.5 Advice Options: Meal Rise, Snack Size, Acting Time, Oset Time ..................................130
9.6 Time Blocks: Bolus Advice Is Not Set Up.......................................................................132
9.7 Warning Limits: Hypo, Hyper.........................................................................................135
9.8 Key Lock ......................................................................................................................137
9.9 Language .....................................................................................................................138
9.10 Carbs (Carbohydrates) Unit.........................................................................................139
9.11 Beeper, Vibrate, Key Sound.........................................................................................140
9.12 Time Format, Time, Date.............................................................................................142
9.13 Backlight Level...........................................................................................................144
Chapter 10: Meter Reminders ..........................................................................................145
10.1 Overview ....................................................................................................................145
10.2 bG Test Reminders: After High bG, After Low bG, After Meal .......................................146
10.3 Alarm Clock Reminders: bG Test, Other.......................................................................150
10.4 Date Reminders: Dr. Visit, Lab Test, Infusion Set Change.............................................153
Chapter 11: Meter and Pump Communication ................................................................157
11.1 Overview ....................................................................................................................157
11.2 Turning Bluetooth Wireless Technology On or O ........................................................158
11.3 Pairing the Meter and Pump.......................................................................................160
11.4 Cancelling the Pairing of the Meter and Pump Prompt................................................164
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Chapter 12: Care and Maintenance .................................................................................165
12.1 Overview ....................................................................................................................165
12.2 Testing the Display .....................................................................................................165
12.3 Changing the Batteries ...............................................................................................166
12.4 Power‑Saving Tips......................................................................................................167
12.5 Cleaning the Meter .....................................................................................................168
Chapter 13: Troubleshooting ............................................................................................169
13.1 Overview ....................................................................................................................169
13.2 Warnings ....................................................................................................................171
13.3 Errors .........................................................................................................................184
Chapter 14: Product Information .....................................................................................191
14.1 Specifications and Limitations ....................................................................................191
14.2 Technical Information..................................................................................................192
14.3 Information for Healthcare Professionals ....................................................................193
14.4 Explanation of Symbols ..............................................................................................194
14.5 Guarantee...................................................................................................................195
14.6 Additional Supplies .....................................................................................................195
14.7 Discarding the Meter ..................................................................................................195
14.8 Meter Default Settings and Range Limits....................................................................196
Appendices .......................................................................................................................199
Appendix A: List of Icons.....................................................................................................199
Appendix B: Bolus Advice Overview ....................................................................................201
Appendix C: Bolus Advice Calculations................................................................................209
Glossary ............................................................................................................................213
Index .................................................................................................................................221
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5
Introduction
Read this User’s Manual carefully before you operate your Accu-Chek Aviva Combo meter. To use your
meter correctly and dependably, you need to understand its operation, screen displays and all individual
features. If you have any questions, contact one of our customer support and service centres. A listing is
at the back of this manual.
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 test strips. Using other test strips will give inaccurate results.
If you have followed the steps in this manual but still have symptoms that do not seem to match your
blood glucose results, or if you have questions, talk to your healthcare professional.
NOTE
• In this manual, “meter” always refers to the Accu-Chek Aviva Combo blood glucose meter
and “pump” always refers to the Accu-Chek Spirit Combo insulin pump.
• This manual shows sample screens. The screens in this manual may look slightly dierent from
the screens on the meter.
• On the meter screens, the activation chip is referred to as a code key. Code key and activation
chip are interchangeable and mean the same thing.
Introduction
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6
Introduction
The Accu-Chek Aviva Combo System
The Accu-Chek Aviva Combo blood glucose monitoring system is intended for the quantitative
measurement of blood glucose. The Accu-Chek Aviva Combo system is intended for self-testing outside
the body (in vitro diagnostic use) by people with diabetes and/or by healthcare professionals in a clinical
setting as an aid to eective diabetes management. Testing sites include the traditional fingertip site.
The Accu-Chek Aviva Combo meter can also be used to interface with and remotely control compatible
Accu-Chek insulin infusion pumps via Bluetooth®wireless technology (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.
Suitable for self-testing
The system includes:
• Accu-Chek Aviva Combo meter with pre-inserted activation chip and three AAA batteries
• Accu-Chek Aviva test strips*
• Accu-Chek Aviva control solutions*
*Some items may not be included in the kit. They are a separate purchase.
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7
Understanding Your New System 1
1.1 Safety Information
wWARNING
• Choking hazard. Small parts. Keep away from children under the age of 3 years.
• 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 - Fourth Edition; CLSI document M29-A4, 2014).
• 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.
• When travelling on an aircraft, you must ensure that the Bluetooth function is turned o on
the meter and on the pump prior to closure of the aircraft door. Refer to the Turning Bluetooth
Wireless Technology On or O section in the chapter Meter and Pump Communication.
1.2 Summary of Features
In addition to testing your blood glucose level, your new meter has the following features:
• The meter and pump are able to communicate with each other. The meter can control your pump,
and pump information is automatically uploaded to the meter.
• You can enable bolus advice which provides recommendations on the amount of insulin for food intake
and for correcting blood glucose levels that are not within your target range. Bolus advice takes into
account the time of day and your changing situations.
• You can administer a bolus in dierent ways.
• Remotely on your pump via Bluetooth wireless technology
• Independently on your pump
• Using an insulin pen or syringe
Chapter 1: Understanding Your New System
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8
Understanding Your New System
1
• Time blocks allow you to divide a day into dierent time periods.
• Setting time blocks to fit your own schedule helps you and your healthcare professional to see
how patterns in your blood glucose are aected by your daily activities and lifestyle.
•Time blocks can be set up with or without the bolus advice feature activated.
• The meter has five default time blocks per day. You are able to set up from one to eight time blocks
per day.
• The meter collects your data, such as blood glucose results and boluses, and stores up to 1,000 records in
the diary.
• You can view, modify or add information to a record, such as meal time, amount of carbohydrates
and health event.
• You can view your blood glucose test averages, trends, standard day, standard week and target data.
• You can view the data as a graph or in a table format for the last 7, 14, 30, 60 or 90 days.
• You can transfer the data stored in the meter to a computer.
• The meter informs you of the occurrences of reminders, warnings and errors with a message on the display
and can also emit sounds and/or vibrations.
• You can set hypo (low) and hyper (high) blood glucose limits that best fit your needs. Whenever a blood
glucose result is above or below this range, the meter displays a warning.
• Reminders are available to help you remember a variety of tasks.
• Blood glucose test reminders prompt you to retest your blood glucose after a high blood glucose result,
after a low blood glucose result or after a meal.
• You can schedule up to eight dierent alarm clock reminders to notify you daily when to perform
a blood glucose test, or for other events.
• Date reminders can be set for upcoming events, such as a Dr. visit, a lab test or a pump infusion
set change.
•You can set certain meter functions to your personal preference.
• The meter has the option to emit a sound and/or vibrate for each button press.
• The backlight helps you read the information on the meter display under dierent lighting conditions.
• The key lock allows you to lock all of the buttons on the meter, except for the power button. It serves
as a safety measure against unintentional activation of meter functions.
• The meter has a full-colour graphic display.
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9
Understanding Your New System 1
1. Display
Shows menus, test results, messages
and data stored in the diary.
2. Left/Right Soft Keys
Select the option shown on the screen
above a soft key.
3. Arrow Buttons
Move around a screen, or adjust the value
for an entry field.
4. Backlight Button
Adjusts the backlight level. Or, when the
Bluetooth screen is displayed, press and
hold to turn the Bluetooth function on or off.
5. Test Strip Slot
Insert a test strip here.
6. Power Button
Turns the meter on or o.
7. Enter Button
Selects a menu option or an entry field value.
Saves changes and exits the entry field.
1.3 The Accu‑Chek Aviva Combo Meter at a Glance
1
2
3
4
5
7
6
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10
Understanding Your New System
1
8. Infrared (IR) Window
Transfers data from the meter to a computer (PC)
using an infrared cable and computer software.
9. Activation Chip Slot
Activation chip is pre-inserted here.
10. Battery Door
Remove to replace the batteries.
Button Combinations Function
Press and hold and simultaneously. Unlocks the buttons whenever the Key
Lock feature is turned on.
With the meter turned o, press and hold and then press
and hold .
Begins the meter and pump pairing
process.
8
9
10
Back of the Meter
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11
Understanding Your New System 1
11. Test Strip Container*
(for example)
12. Test Strip* – Metallic End
Insert this end into the meter.
13. Test Strip* – Yellow Window
Touch blood drop or control solution here.
14. Control Solution Bottle*
(for example)
15. Activation Chip
See NOTE.
16. Batteries
(high-quality batteries are recommended)
*Some items may not be included in the kit. They are a separate purchase.
NOTE
Your meter is already coded and comes with a pre-inserted black activation chip that you never need to
change, even if you use test strips from boxes that contain an activation chip that is a dierent colour
or has dierent numbers.
11
12
13
15
16
14
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12
Understanding Your New System
1
1.4 Test Strips
• Use only Accu-Chek Aviva test strips.
• Use the test strip immediately after removing it from the test strip container.
• Do not apply blood or control solution to the test strip before you insert it into the meter.
• Close the test strip container tightly immediately after removing a test strip to protect the test strips
from humidity.
•Store the unused test strips in their original test strip container with the cap closed.
• Check the use by date on the test strip container. Do not use the test strips after that date.
• Store the test strip container and meter in a cool, dry place, such as a bedroom.
• Refer to the test strip package insert for test strip storage and system operating conditions.
wWARNING
Do not store test strips in high heat and moisture areas (bathroom or kitchen)! Heat and moisture
can damage test strips.
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13
Understanding Your New System 1
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.
NOTE
• Press or insert a test strip to turn the meter on. If the meter displays the Time/Date screen,
make the necessary changes and select Save.
• The meter turns o automatically in approximately two minutes if no buttons are pressed.
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14
Understanding Your New System
1
Features on the Main Menu
1. Sound Icon
Displayed when the beeper is turned on.
2. Time
3. Vibrate Icon
Displayed when vibrate is turned on.
4. Date
5. Low Battery Icon
Displayed when the meter batteries are low
in power.
6. Menu Options
To make a selection, press or to highlight
the menu item in blue and then press .
7. Bluetooth Icon
Indicates the meter’s communication state.
Refer to the following table.
3
4
1
5
1
6
7
2
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15
Understanding Your New System 1
Bluetooth Icon Communication States
You may turn the Bluetooth function on or o at any time using the meter.
Icon Communication State
The Bluetooth function is on. The meter and pump are communicating.
When the icon is not shown, the Bluetooth function is o. The meter and pump
are not communicating.
When the icon is flashing, the Bluetooth function is on. However, the meter and pump
are not communicating.
Connecting to the Pump screen
This screen is displayed for a few seconds when the Bluetooth function is on and the meter is connecting
to the pump.
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16
Understanding Your New System
1
Features on a screen
1. Title Bar
Primary menu title is displayed here.
2. Highlighted Option
When a menu choice or item is selected,
it is highlighted in blue.
3. Left Soft Key Option
Press to select the option shown
on the screen above the left soft key.
4. Secondary Title Bar
When necessary, a secondary title bar
displays additional information.
5. Scroll Bar
When there is more information available
than fits on the screen, a vertical scroll bar
is shown on the right side of the screen.
6. Right Soft Key Option
Press to select the option shown
on the screen above the right soft key.
1
2
3
4
5
6
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17
Understanding Your New System 1
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.
1. To open a pop-up menu or entry field, select it and press .
2. Press or to select the appropriate pop-up menu option or until the desired numerical entry
is displayed. Press and hold or to scroll faster.
3. Press to confirm.
1. Pop‑Up Entry Field
2. Pop‑Up Menu
1
2
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18
Understanding Your New System
1
General Navigation Steps
1
Press or to select a menu option and press .
NOTE
Specific to the Time Blocks menu selection: If the bolus advice feature has been activated,
then the Time Blocks selection is found under the Bolus Advice menu option.
Press or or or to
select the desired entry field
and press .
2
Press or to set the
desired entry and press .
Repeat Steps 2 and 3 as
necessary for other entry
fields.
3
Select Save by pressing
to save changes and return
to the previous screen.
To return to the previous
screen without saving
changes, select Cancel
by pressing .
4
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