Accu-Chek Aviva User manual

Aviva Combo
00048010155/C-0613
Roche USA – 51638
V6/1 – 00048010155/C – Black –
Roche USA – 51638
V6/2 – 00048010155/C – Cyan –
Roche USA – 51638
V6/3 – 00048010155/C – Magenta –
Roche USA – 51638
V6/4 – 00048010155/C – Yellow –
Roche USA – 51638
V6/5 – 00048010155/C – PMS 287 –
Roche USA – 51638
V6/6 –00048010155/C – PMS 5445 –
BLOOD GLUCOSE METER
Standard Owner’s Booklet
for Self-Testing Only
©2013 Roche Diagnostics
Assembled in USA.
Distributed by:
Roche Health Solutions Inc.
11800 Exit 5 Parkway, Suite 120
Fishers, IN 46034
Phone: [phone]
Fax: [phone]
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.
Aviva Combo
Aviva Combo
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LAST UPDATE: 2012-08
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i
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.
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 –
NOTE
The terms “blood sugar” and “blood glucose” have the same meaning. In this manual we will use the
term “blood glucose” when referring to “blood sugar.”
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About Your New Meter
• The meter is designed and can be used for testing fresh capillary whole blood samples (for example, blood
from a fingertip).
• Only use ACCU-CHEK Aviva Plus test strips. Other test strips will give inaccurate results.
• Although you always apply whole blood to the test strip, the system has been calibrated to deliver
plasma-like values for easier comparison to lab results.
• The meter, test strips, and control solution are only for use outside the body (in vitro). Do not eat the test
strips. Do not swallow or inject the control solution, or use the control solution for any purpose other than
testing the ACCU-CHEK Aviva Combo system.
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About Testing Yourself or Others
• If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you think you are
dehydrated, call your healthcare professional right away.
• Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia). Others, such
as children or people who are unconscious or have certain disabilities, may not be able to communicate
their symptoms to caregivers. For these reasons, do not change any treatment without first talking to a
healthcare professional.
• Run a control test when you open a new box of test strips or if you think that your test result is incorrect.
Running a control test lets you know that the meter and test strips are working properly.
• If peripheral circulation is impaired, collection of fresh capillary whole blood from the approved sample sites
is not advised as the results might not be a true reflection of the physiological blood glucose level. This may
apply in the following circumstances: severe dehydration as a result of diabetic ketoacidosis or due to
hyperglycemic hyperosmolar non-ketotic syndrome, hypotension, shock, decompensated heart failure NYHA
Class IV, or peripheral arterial occlusive disease.
• Not to be used for patients who are critically ill.
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• Refer to the Test Strip and Control Solution package Inserts for additional health-related information.
• It is always a good idea to have a back-up testing method available. Failure to test could cause a delay in
treatment decisions and lead to a serious medical condition. Examples of back-up testing methods include
a back-up meter or testing by a lab. Ask your healthcare professional or pharmacist about other possible
back-up methods.
DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH
HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.
If your blood glucose result doesn’t match how you feel and you have followed the instructions in your
owner’s booklets, follow your healthcare professional’s instructions or call your healthcare professional.
Special Information to Consider When Using This Meter
• Do not use this device to measure blood glucose if you or a person to whom you are providing care is
experiencing cardiovascular collapse (severe shock) or decreased peripheral blood flow.
• Consult your healthcare professional to determine if it is appropriate for your child to be taught how to use
the meter system or any other medical products.
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1
Contents
Before You Start Testing i
Introduction 7
The ACCU-CHEK Aviva Combo System 8
1 Understanding Your New System 11
1.1 Overview 12
1.2 The ACCU-CHEK Aviva Combo Meter at a Glance 13
1.3 The ACCU-CHEK Spirit Combo Insulin Pump at a Glance 19
1.4 Summary of Features 20
1.5 Screen Content and Navigation 30
2 Testing Your Blood Glucose 39
2.1 Overview 40
2.2 Using the ACCU-CHEK Aviva Combo System 41
2.3 Performing a Blood Glucose Test 43
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2.4 Detailed Blood Glucose Test Results 51
2.5 Understanding Blood Glucose Test Results 55
2.6 Unusual Blood Glucose Test Results 59
2.7 Symptoms of High or Low Blood Glucose 61
3 Control Testing 63
3.1 Overview 64
3.2 Why Perform Control Tests 65
3.3 About the Control Solutions 66
3.4 Performing a Control Test 67
3.5 Understanding Control Test Results 73
4 Managing Your Data 79
4.1 Overview 80
4.2 Viewing or Modifying Your Data 83
4.3 Adding New Data 92
4.4 Reporting Your Data 95
4.5 Downloading Your Data to a Computer 133
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5 Changing Meter Settings 137
5.1 Overview 138
5.2 Setting bG Test Reminders: After High bG, After Low bG, After Meal 139
5.3 Setting Alarm Clock Reminders: bG Test, Other 144
5.4 Setting Date Reminders: Dr. Visit, Lab Test, Infusion Set Change 147
5.5 Setting Bolus Advice for the First Time 152
5.6 Setting Time Blocks, Health Events, Advice Options: Bolus Advice Set Up 161
5.7 Setting Warning Limits: Hyper, Hypo 170
5.8 Turning Key Lock On or O 173
5.9 Setting the Language 176
5.10 Setting Units: Carbs 179
5.11 Turning Bluetooth® Wireless Technology On or O 182
5.12 Pairing the Meter and Pump 184
5.13 Setting the Beeper, Vibrate, Key Sound 185
5.14 Setting the Time Format, Time, Date 188
5.15 Setting Time Blocks: Bolus Advice Not Set Up 191
5.16 Backlight Settings 199
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6 Icons, Reminders, Warnings, and Errors 201
6.1 Overview 202
6.2 List of Icons 203
6.3 Confirming a Reminder, Warning, or Error 205
6.4 List of Reminders 206
6.5 List of Warnings 216
6.6 List of Errors 222
7 Cleaning and Disinfecting the Meter and Lancing Device 225
7.1 Overview 226
7.2 Cleaning and Disinfecting the Meter 228
7.3 Cleaning and Disinfecting the Lancing Device 233
8 Maintenance 237
8.1 Overview 238
8.2 Changing the Batteries 239
8.3 Power-Saving Tips 242
8.4 Maintenance and Testing 243
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9 Troubleshooting 245
9.1 Overview 246
9.2 Troubleshooting the ACCU-CHEK Aviva Combo Meter 247
10 Technical Information 265
10.1 Overview 266
10.2 Product Limitations 267
10.3 Specifications 268
10.4 Product Safety Information 270
10.5 Disposing of the Meter, Strips, Lancets, and Batteries 273
10.6 Warranty and Limited License 275
10.7 Additional Supplies 282
Appendices 283
Appendix A: Abbreviations 283
Appendix B: Carb Units 285
Appendix C: Explanation of Symbols 286
Appendix D: Meter Settings and Range Limits 287
Appendix E: References 292
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Glossary 293
Index 301
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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
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.
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 eectiveness 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 dierence 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
11
1 Understanding Your New System
1.1 Overview 12
1.2 The ACCU-CHEK Aviva Combo Meter at a Glance 13
1.3 The ACCU-CHEK Spirit Combo Insulin Pump at a Glance 19
1.4 Summary of Features 20
1.5 Screen Content and Navigation 30
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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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13
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
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
Backlight Button
Press to adjust the backlight level
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Test Strip
Batteries
Insert batteries according to the + and - symbols in
the battery compartment.
Control Solution Bottle
(for example)
Yellow Window -
Touch blood drop or
control solution here.
Golden End -
Insert this end of the test
strip into the meter.
Test Strip Container
(for example)
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