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Blood Glucose Meter
FreeStyle Libre 3
Abbott FreeStyle Libre 3 User Manual
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DOC44383_rev-C 1:14pm 22-SEP-2021
2
Table of Contents
Important Safety Information
2
Indications for Use
3
Important Safety Information
3
Compatible Devices, Apps, and Software
4
Contraindications
4
Warnings
4
How to Store the Sensor Kit
8
When Not to Use the System
8
What to Know about the System
8
What to Know before You Apply the Sensor
8
What to Know about X-Rays
9
When to Remove the Sensor
9
When Is Sensor Glucose Different from Blood Glucose
9
Interfering Substances
10
App Symbols
10
Getting to Know Your System
12
Sensor Kit
13
Freestyle Libre 3 App
14
Home Screen
15
Reporting Software
16
Setting up Your System for the First Time
16
Applying Your Sensor
17
Starting Your Sensor
23
Checking Your Glucose
25
Understanding Your Glucose Readings
27
Glucose Trend Arrow
27
Messages
28
Making Treatment Decisions
30
Making Treatment Decisions – Getting Started
31
Helpful Tips
32
Think Your Readings Are Incorrect?
34
Symptoms Don’t Match Readings
34
When to Do Nothing and Check Again Later
34
Using Your Glucose Reading to Make a Treatment Decision
35
Treatment Decision Considerations for Glucose Trend Arrow
36
Other Considerations
50
Meal Dosing
50
High Glucose Corrections
50
Bedtime
50
App Alarms
51
Optional Glucose Alarms
51
Urgent Low Glucose
51
Optional Signal Loss Alarm
51
Fixed System Alarms
52
Setting App Alarms
54
Low Glucose Alarm
54
High Glucose Alarm
55
Signal Loss Alarm
56
Using App Alarms
57
Urgent Low Glucose Alarm
57
Adding Notes
59
App Stopped Alarm
59
Reviewing Your History
60
Logbook
60
Other History Options
61
Time in Ranges
61
Low Glucose Events
61
Average Glucose
61
Sensor Usage
62
Glucose Management Indicator
62
Removing Your Sensor
62
Replacing Your Sensor
63
Using Reminders
64
Living with Your System
66
Activities
66
Bathing, Showering, and Swimming
66
Traveling by Air
66
Settings and Other Menu Options
67
App Settings
67
Account Settings
67
Connected Apps
67
Maintenance and Disposal
68
Troubleshooting
68
Problems at the Sensor Application Site
68
The Sensor Is Not Sticking to Your Skin
69
Skin Irritation at the Sensor Application Site
69
Problems Starting Your Sensor
69
Scan Error
69
Enable Bluetooth
70
Incompatible Sensor
70
Replace Sensor
70
Allow Access to Critical Alerts
70
Sensor Ready in X Minutes
71
Check Sensor
71
Sensor Ended
71
Signal Loss
71
Bluetooth off
72
Sensor Error
72
Sensor too Hot
72
Sensor too Cold
72
Problems Receiving Alarms
73
Unexpected Application Error
73
System Specifications
75
Labeling Symbols
76
Quality of Service (Qos)
76
Performance Characteristics
78
Overview of Clinical Studies
78
Accuracy
79
Accuracy to YSI Within CGM Glucose Ranges
80
Accuracy to YSI Within YSI Glucose Ranges
81
Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference
81
Concurrence Analysis with ‘LO’ CGM Reading
82
Concurrence Analysis with ‘HI’ CGM Reading
82
Concurrence of System and Reference (CGM Vs. YSI)
83
Concurrence Analysis by CGM Glucose Level
83
Glucose Rate of Change Accuracy
85
Concurrence Analysis by Glucose Rate of Change
85
Alarm Performance
86
Low Glucose Alarm Performance
86
True Alarm Rate
86
False Alarm Rate
86
Missed Detection Rate
87
High Glucose Alarm Performance
88
Detection Rate
88
Sensor Accuracy over Time
90
Sensor Wear Duration
90
Sensor Survival Rate over Wear Duration
91
Glucose Reading Availability
91
Precision
92
Adverse Events
92
Overall between Sensor Precision
92
Ascorbic Acid Interference
93
Additional Notes for Health Care Professionals
93
Electromagnetic Compatibility (EMC)
93
Other manuals for Abbott FreeStyle Libre 3
Quick Start Guide
39 pages
Getting Started
31 pages
Quick Reference Guide
14 pages
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Abbott FreeStyle Libre 3 Specifications
General
Brand
Abbott
Model
FreeStyle Libre 3
Category
Blood Glucose Meter
Language
English
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