Table Of Contents - Abbott FreeStyle Libre 2 User Manual

Table of Contents

Warning3
Table Of Contents4
Important Safety Information7
Indications For Use7
Compatible Devices, Apps, And Software8
Contraindications8
Cautions And Limitations9
What To Know About Glucose Alarms9
Warnings9
What To Know Before Using The System10
Who Should Not Use The System10
What Should You Know About Wearing A Sensor11
How To Store The Sensor Kit13
When Not To Use The System13
What To Know Before You Apply The Sensor14
When Is Sensor Glucose Different From Blood Glucose15
What To Know About X-Rays16
When To Remove The Sensor16
What to Know about the Reader's Built-In Meter17
Where To Charge Your Reader17
Interfering Substances18
Reader Symbols19
Getting To Know Your System21
Reader Kit23
The Reader Kit Includes23
Sensor Kit24
The Sensor Kit Includes24
Home Screen25
Sensor Glucose Readings26
Freestyle Libre Software27
Intended Use27
Setting Up Your Reader For The First Time28
Using Your Sensor31
Applying Your Sensor32
Starting Your Sensor36
Checking Your Glucose37
Making Treatment Decisions43
Making Treatment Decisions – Getting Started44
Helpful Tips44
No Current Glucose Number46
Sensor47
Think Your Readings Are Incorrect?47
Symptoms Don't Match Readings48
When To Do Nothing And Scan Again Later48
Using Your Glucose Reading To Make A Treatment Decision49
Treatment Decision Considerations50
Example Scenarios55
When You Wake-Up55
Before Breakfast56
Before Lunch57
After Lunch57
In The Afternoon58
After Exercising58
Before Dinner59
Other Considerations60
Meal Dosing60
High Glucose Corrections60
Bedtime61
Other Factors61
Alarms62
Setting Alarms65
Low Glucose Alarm67
High Glucose Alarm68
Signal Loss Alarm68
Setting Alarm Sounds70
Using Alarms71
Adding Notes73
Reviewing Your History75
Logbook77
Daily Graph78
Other History Options79
Removing Your Sensor81
Replacing Your Sensor82
Using Reminders83
Using the Reader's Built-In Meter85
Blood Glucose Testing89
Your Blood Glucose Results92
Accuracy Of The Reader's Built-In Meter95
Accuracy Results For All Glucose Concentrations95
Control Solution Testing96
Control Solution Results100
Example Screen Only100
Charging The Reader101
Changing The Reader Settings102
Living With Your System105
Maintenance And Disposal108
Cleaning And Disinfecting The Reader108
Maintenance112
Disposal112
Troubleshooting113
Reader Does Not Power On113
Problems At The Sensor Application Site114
Problems Starting Your Sensor Or Receiving115
Sensor Readings115
Problems Receiving Glucose Alarms119
Blood Glucose Error Messages121
Problems Checking Your Blood Glucose125
Perform A Reader Test127
Customer Service127
System Specifications128
Sensor Specifications128
Reader Specifications130
Labeling Symbols134
Performance Characteristics136
Overview Of Clinical Studies136
Adult Study136
Pediatric Study136
Accuracy137
Overall Accuracy To Ysi138
Accuracy To Ysi Within Cgm Glucose Ranges139
Agreement with 'LO' and 'HI' CGM Reading against YSI Reference143
Concurrence Analysis with 'LO' CGM Reading143
Concurrence Analysis with 'HI' CGM Reading144
Concurrence Of System And Reference (Cgm Vs. Ysi)145
Concurrence Analysis By Cgm Glucose Level146
Glucose Rate Of Change Accuracy150
Concurrence Analysis By Glucose Rate Of Change151
Alarm Performance151
Low Glucose Alarm Performance151
True Alarm Rate151
False Alarm Rate152
Detection Rate152
Missed Detection Rate152
High Glucose Alarm Performance154
Sensor Accuracy Over Time156
Sensor Accuracy Relative To Ysi Over The Wear Duration157
Sensor Wear Duration158
Sensor Survival Rate Over Wear Duration159
Glucose Reading Availability161
Glucose Reading Capture Rate Over Wear Duration161
Precision163
Overall Between Sensor Precision163
Adverse Events164
Ascorbic Acid Interference164
Additional Notes For Health Care Professionals164
Electromagnetic Compatibility (Emc)165
Guidance and Manufacturer's Declaration166
Electromagnetic Emissions166
Electromagnetic Immunity167
Limited Warranty177