Main
Users Guide
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Indications for Use
Contraindications
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How to Use this Guide?
Table of Contents
nSection 3: Set the Time and Date ................................................21 23
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Section 1 Key Terms
1 Getting Acquainted
Introduction
Getting Acquainted
How are the parts packaged?
2 Section 1
OVER
What are the key parts of my system?
Your FreeStyle Navigator system includes the following major parts:
Sensor Delivery Unit Transmitter Receiver
Getting Acquainted
Key features of the System
Statistics
Alarms
event Log Line Graph
4 Section 1
Using your system
Getting Acquainted
How do I prepare my system for the rst time?
Warnings, Cautions And Important Notes
Important Things to Remember About System Calibration
Getting Acquainted
Important Things to Remember About System Calibration
Before You Get Started
8 Section 1
Before Y ou Get Started
Getting Acquainted
Helpful health related information:
Before Y ou Get Started
Customer Care: 1-866-597-5520
10 Section 1
What is Hypoglycemia Unawareness?
Symptoms of Hypoglycemia Unawareness:
Getting Acquainted
What are the Continuous Monitoring mode and Blood Glucose mode?
Continuous Monitoring Mode (Glucose CM)
Blood Glucose Mode (Glucose BG)
12 Section 1
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Section 2 Key Terms
2 Install or Replace Transmitter and Receiver Batteries
Purpose
Materials
Section 2 15 Install or Replace Transmitter and Receiver Batteries
Install or Replace the Transmitter Battery
Install or Replace the Receiver Batteries
Match what you see on your Receiver with ONE of the screen shots shown below.
If the display is en
Section 2 17 Install or Replace Transmitter and Receiver Batteries
Reconnect the Receiver to the Transmitter.
o
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Section 3 Key Terms
3 Set the Time and Date
Purpose Start Do this procedure:
Materials
1.
Section 3 21 Set the Time and Date
2.
3.
the System Menu screen.
4.
22 Section 3
5.
6.
o o
Section 3 23 Set the Time and Date
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Section 4 Key Terms
4 Perform a Control Solution Test
Purpose
Start
Section 4 27 Perform a Control Solution Test
1.
2.
3.
4.
Section 4 29 Perform a Control Solution Test
5.
6.
control solution.
30 Section 4
7.
8.
o o o
If the result And en
Section 4 31 Perform a Control Solution Test
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Section 5 Key Terms
5 Insert or Remove Your Sensor
Purpose
Section 5 35 Insert or Remove Your Sensor
1.
If you want to en
36 Section 5 Insert or Remove Your Sensor
2.
Section 5 37 Insert or Remove Your Sensor
3.
4.
the transmitter.
5.
38 Section 5 Insert or Remove Your Sensor
6.
7.
unit from package.
8.
the sensor support mount.
9.
10.
13.
11.
12.
Section 5 41 Insert or Remove Your Sensor
Steps Do This 14.
mount.
Customer Care: 1-866-597-5520
42 Section 5 Insert or Remove Your Sensor
15.
16.
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Section 6 Key Terms
6 Attach Your Transmitter
Purpose Start Materials
Section 6 47 Attach Your Transmitter
1.
2.
If en
3.
(Optional).
4.
your receiver.
Section 6 49 Attach Your Transmitter
5.
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Section 7 Key Terms
7 Calibrate Your System/Test Blood Glucose Manually
Purpose
Materials
Section 7 53 Calibrate Your System/Test Blood Glucose Manually
Helpful Information (cont)
54 Section 7
Helpful Information (cont)
Section 7 55 Calibrate Your System/Test Blood Glucose Manually
1.
the receivers test strip port.
If en
2.
on the screen matches the code number on the test strip vial.
3.
n
Section 7 57 Calibrate Your System/Test Blood Glucose Manually
4.
If your test site is en
58 Section 7
4.
If you are lancing en
If you are using en to stimulate blood ow
Section 7 59 Calibrate Your System/Test Blood Glucose Manually
5.
60 Section 7
6.
Section 7 61 Calibrate Your System/Test Blood Glucose Manually
7.
results.
8.
62 Section 7
9.
10.
11.
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Section 8 Key Terms
8 Set, Review, or Change the Alarm Settings
Purpose
Start
Materials
Section 8 67 Set, Review, or Change the Alarm Settings
About Glucose Alarms
68 Section 8
High Threshold (180 mg/dL) Low Threshold (80 mg/dL)
About Glucose Alarms (cont)
1.
2.
If you want to en
70 Section 8
3.
Low Glucose alarm.
Section 8 71 Set, Review, or Change the Alarm Settings
Steps Do This 4.
High Glucose alarm.
72 Section 8
5.
Projected Low glucose alarm.
Section 8 73 Set, Review, or Change the Alarm Settings
Steps Do This 6.
Projected High glucose alarm.
74 Section 8
7.
Data Loss alarms.
Section 8 75 Set, Review, or Change the Alarm Settings
8.
If en
Customer Care: 1-866-597-5520
76 Section 8
9.
Section 8 77 Set, Review, or Change the Alarm Settings
10.
1 hour.
11.
12.
78 Section 8
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Section 9 Key Terms
9 Daily Use
Purpose Start
Materials
Section 9 81 Daily Use
1.
2.
transmitter.
If you want to en go to this Step
If the receiver has en lost connection
3.
Location Description
Section 9 83 Daily Use
4.
is Icon Means
84 Section 9
5.
6.
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Section 10 Key Terms
10 Respond to Alarms, Errors, and Problems
Purpose Start
Materials
If the level of en the alarm urgency is
Section 10 89 Respond to Alarms, Errors, and Problems
Status Information
Status Information Description
90 Section 10
Alarms and Errors
85
Status Information (cont)
Status Information Description
Display Description
Respond to alarm message:
92 Section 10
Section 10 93 Respond to Alarms, Errors, and Problems
94 Section 10
Section 10 95 Respond to Alarms, Errors, and Problems
96 Section 10
Section 10 97 Respond to Alarms, Errors, and Problems
98 Section 10
Section 10 99 Respond to Alarms, Errors, and Problems
Respond to Blood Glucose Mode error codes.
100 Section 10
Troubleshoot problems
Section 10 101 Respond to Alarms, Errors, and Problems
The receiver will not turn on.
The Blood Glucose test wont start after you apply a sample.
102 Section 10
Section 10 103 Respond to Alarms, Errors, and Problems
There is no glucose value on the screen.
104 Section 10
Skin irritation at sensor insertion site.
If the irritation is en
The sensor support mount is not sticking to your skin.
Section 10 105 Respond to Alarms, Errors, and Problems
Discomfort when inserting the sensor.
106 Section 10
You are not sure whether your receiver and transmitter are connected.
Section 10 107 Respond to Alarms, Errors, and Problems
The system does not prompt you with a message to do BG test for calibration.
Check your work.
108 Section 10
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Section 11 Key Terms
11 Add Events
Purpose Start
Materials
1.
Section 11 111 Add Events
2.
want to record.
3.
If the event deals with en
112 Section 11
5 .
6 .
Section 11 113 Add Events
7.
8. Check your work.
114 Section 11
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Section 12 Key Terms
12 Re view Reports and Edit Events
Purpose
Start
1.
the Main menu.
2.
3.
118 Section 12
4.
glucose level history.
Section 12 119 Review Reports and Edit Events
5.
of your glucose levels.
120 Section 12
6.
reading.
If you want to know en highlight
Section 12 121 Review Reports and Edit Events
7.
event history.
If you want to en
If you want to At en highlight review/edit your
122 Section 12
8.
Event Note s
Section 12 123 Review Reports and Edit Events
9.
10.
o o
o
124 Section 12
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13 C lean Your System
Purpose
Materials
Section 13 127 Clean Your System
1.
2.
3.
o
128 Section 13
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Section 14 Key Terms
14 L ink and Unlink Your Transmitter and Receiver
Purpose
Materials
Section 14 131 Link and Unlink Your Transmitter and Receiver
1.
2.
your transmitter.
If you want to en go to Step
132 Section 14
3.
transmitter.
o o o
o
If the And this en ID numbers is your
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15 Rese t User Settings
Purpose Start
Materials
1.
Section 15 137 Reset User Settings
2.
Settings screen.
3.
o o
If you want to en
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Section 16 Key Terms
16 C hange Country Settings
Purpose Start
Materials
1.
from the Main menu
2. Access the Country Settings
menu.
3.
If you want to change how en go this is displayed to Step
142 Section 16
4.
5.
Section 16 143 Change Country Settings
6.
7.
144 Section 16
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Section 17 Appendix A
17 Appendix A: Site Maintenance
Introduction
Site Selection
Helpful products
Section 17 147 Appendix A: Site Maintenance
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Section 18 Appendix B
18 Appendix B: Specications
System Specications
Section 18 151 Appendix B: Specications
152 Section 18
Performance Characteristics
Section 18 153 Appendix B: Specications
Accuracy
154 Section 18
Section 18 155 Appendix B: Specications
156 Section 18
Section 18 157 Appendix B: Specications
158 Section 18
Figure 2. Sample of a Representative Excellent Glucose Trace
Figure 3. Sample of a Representative Average Glucose Trace
Figure 4. Sample of a Representative Poor Glucose Trace
Section 18 159 Appendix B: Specications
Determination of Alarm Performance
160 Section 18
OVER
Detection of Low Glucose
Detection of High Glucose
* T rue Alarms are the
Section 18 161 Appendix B: Specications
Measuring Glucose in Interstitial Fluid
Precision
Sensor Insertion, Calibration and Sensor Wear
Skin Interaction
162 Section 18
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19 Appendix C: FCC Compliance Information
Electromagnetic Interference and Your FreeStyle Navigator Continuous Glucose Monitoring System
Section 19 165 Appendix C: Classication/Compliance/Declaration
Guidance and Manufacturers Declaration Electromagnetic Emissions
Compliance Level
166 Section 19
Guidance and Manufacturers Declaration - Electromagnetic Immunity. (cont)
Section 19 167 Appendix C: Classication/Compliance/Declaration
168 Section 19
Section 19 169 Appendix C: Classication/Compliance/Declaration
Classication
FCC Compliance Information
170 Section 19
Section 19 171 Appendix C: Classication/Compliance/Declaration
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20 Glossary
Section 20 175 Glossary
176 Section 20
Section 20 177 Glossary
178 Section 20
Section 20 179 Glossary
180 Section 20
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21 Index
Section 21 183 Index
21 Index
184 Section 21