Abbott Diabetes Care LIB01 Freestyle Libre Glucose Monitoring System User Manual

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Document Description	User Manual
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Date Submitted	2014-10-09 00:00:00
Date Available	2015-04-07 00:00:00
Creation Date	2014-10-09 11:30:05
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DO NOT PRINT FROM THIS FILE FOR REFERENCE ONLY
Contents
Reader Symbols . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . .1
Important Safety Information .
. . . . . . . . . . . . . .3
Indications for Use . . . . . . .
. . . . . . . . . . . . . . . .
Contraindications . . . . . . .
. . . . . . . . . . . . . . .
. . . . . . . . . . . .
. . . . . . . . . . . .
. . . . .3
. . . . . . . . . . .
. . . . . . .4
Getting to Know Your System . .
Reader Kit . . . . . . . . . . . . . . . . . . . . . .
Sensor Kit . . . . . . . . . .
. . . . . . . . . . . . . . .
FreeStyle Libre Software . . . . . . . . .
.........................8
.........................9
. . . . . . . . . . . .
. . . . . . . . . . 10
. . . . . . . . . . . . . . . . . . . . . . . . 13
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 14
Using Your Sensor . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . 17
Applying Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 18
Starting Your Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 22
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adding Notes . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 29
Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Daily Graph . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 34
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Removing Your Sensor . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 37
Replacing Your Sensor . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 38
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Using the Built-in Meter . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 41
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Control Solution Testing . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 52
Using the Rapid-Acting Insulin Calculator . . . . . . . . . . . . . . . . 56
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Changing the Reader Settings . . . . . . . . . . . . .
. . . . . . . . . . . . 64
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Problems at the Sensor Application Site . . . . . . . . .
Problems Starting Your Sensor or Receiving Sensor
Readings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Glucose or Ketone Error Messages . . . . . . . . .
Problems Checking Your Blood Glucose or Ketone . . . . .
Perform a Reader Test . . . . . . . . . . . . . . . . . .
81
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
. . . . . . . . . 71
. . . . . . . . . . . . . . 72
. . . . . . . . 75
. . . 79
. . . . . . . . . . . . . . . . . .
Professional Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 82
Changing Dose Increments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Setting up the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . . . . 84
Easy Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . . . . . . 86
Advanced Setup of the Insulin Calculator . . . . . . . . . . . . . . . . . 90
Changing the Insulin Calculator Settings . . . . . . . . . . . . . . . . 101
System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Rapid-Acting Insulin Calculator Specifications . . . . . . . . 106
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . 109
Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 67
Maintenance and Disposal . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . 69
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Reader Symbols
Symbol
What It Means
Symbol
What It Means
Active sensor
Blood glucose or ketone test
Direction your glucose is going . See Checking Your
Glucose section for more information
Settings
Caution
Control solution test result
View previous/next screen
Rapid-acting insulin calculator
Notes
Details of your suggested insulin dose
Add more information to notes
Estimated rapid-acting insulin remaining in body
Food note
Low battery
Rapid-acting insulin note
Battery charging
Time changed on Reader
Sensor too cold
Reminders
Sensor too hot
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Important Safety Information
Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System is indicated
for measuring interstitial fluid glucose levels in adults aged 18 years
and older . It is designed to replace blood glucose testing in the
self-management of diabetes with the exceptions listed below .
Under the following circumstances, use a blood glucose meter
to check the current glucose readings from the FreeStyle Libre Flash
Glucose Monitoring System Sensor:
• During times of rapidly changing glucose levels, interstitial glucose
•
•
levels as measured by the Sensor and reported as current may not
accurately reflect blood glucose levels . When glucose levels are falling
rapidly, glucose readings from the Sensor may be higher than blood
glucose levels . Conversely when glucose levels are rising rapidly,
glucose readings from the Sensor may be lower than blood glucose
levels .
In order to confirm hypoglycemia or impending hypoglycemia as
reported by the Sensor .
If symptoms do not match the FreeStyle Libre Flash Glucose
Monitoring System reading . Do not ignore symptoms that may be
due to low blood glucose or high blood glucose .
DOC28687_rev-E_manual.indd 3-4
Contraindications
The FreeStyle Libre Flash Glucose Monitoring System must be removed
prior to Magnetic Resonance Imaging (MRI) .
WARNING:
• The FreeStyle Libre Flash Glucose Monitoring System contains
small parts that may be dangerous if swallowed .
• During times of rapidly changing glucose (more than 2 mg/dL
per minute), interstitial fluid glucose levels as measured by the
FreeStyle Libre Flash Glucose Monitoring System Sensor may not
accurately reflect blood glucose levels . Under these circumstances,
check the Sensor glucose readings by conducting a fingerstick test
using a blood glucose meter .
• In order to confirm hypoglycemia or impending hypoglycemia as
reported by the FreeStyle Libre Flash Glucose Monitoring System
Sensor, conduct a fingerstick test using a blood glucose meter .
• Do not ignore symptoms that may be due to low or high blood
glucose . If you have symptoms that do not match the FreeStyle
Libre Flash Glucose Monitoring System reading or suspect that
your reading may be inaccurate, check the reading by conducting
a fingerstick test using a blood glucose meter . If you are
experiencing symptoms that are not consistent with your glucose
readings, consult your health care professional .
3/30/14 2:52 PM
CAUTION:
• On rare occasions, you may get inaccurate Sensor glucose
readings . If you believe your glucose readings are not correct
or are inconsistent with how you feel, perform a blood
glucose test on your finger to confirm your glucose . If the
problem continues, remove the current Sensor and apply a
new one .
• Performance of the System when used with other implanted
medical devices, such as pacemakers, has not been
evaluated .
• The Reader is for use by a single person . It must not be used
on more than one person including other family members
due to the risk of spreading infection . All parts of the Reader
are considered biohazardous and can potentially transmit
infectious diseases, even after performing the cleaning
procedure .
System-Related Information
• The FreeStyle Libre Flash Glucose Monitoring System is designed to be
used only with FreeStyle Precision/FreeStyle Optium blood glucose and
blood ketone test strips and MediSense control solution .
• Avoid getting dust, dirt, blood, control solution, water, or other
substances in the Reader’s USB and test strip ports .
• Physiologic differences between the interstitial fluid and capillary blood
may result in differences in glucose readings . Differences in glucose
readings between interstitial fluid and capillary blood may be observed
during times of rapid change in blood glucose, such as after eating,
dosing insulin, or exercising .
• Severe dehydration and excessive water loss may cause inaccurate
results . If you believe you are suffering from dehydration, consult your
health care professional immediately .
Confirm Precision or Optium test strip as appropriate
for market . Change MediSense to Optium for Australia .
DOC28687_rev-E_manual.indd 5-6
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• If you have a medical appointment that includes strong magnetic or
•
electromagnetic radiation, for example an X-ray, MRI (Magnetic
Resonance Imaging), or CT (Computed Tomography) scan, remove the
Sensor you are wearing and apply a new one after the appointment .
The effect of these types of procedures on the performance of the
system has not been evaluated .
The FreeStyle Libre Flash Glucose Monitoring System has not been
evaluated for use in pregnant women, persons on dialysis, or people
less than 18 years of age .
Getting to Know Your System
The FreeStyle Libre Flash Glucose Monitoring System has two main parts: a
handheld Reader and a disposable Sensor, which you wear on your body .
You use the Reader to wirelessly scan the Sensor and get your glucose
readings . The Reader also has a built-in blood glucose and ketone meter,
which works with FreeStyle Precision/FreeStyle Optium blood glucose and
blood ketone test strips .
IMPORTANT: Safety information about the
System is in this User’s Manual . Read all of
the information in the User’s Manual and the
FreeStyle Precision/FreeStyle Optium blood
glucose and ketone test strip instructions for
use before using your System .
Your System comes in a Reader Kit and a Sensor Kit . When opening your
kits, check that the contents are undamaged and that you have all parts
listed . If any parts are missing or damaged, contact Customer Service .
DOC28687_rev-E_manual.indd 7-8
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Reader Kit
Sensor Kit
The Reader Kit includes:
The Sensor Kit includes:
• 1 FreeStyle Libre Reader • 1 Power Adapter • Quick Start Guide
• 1 USB Cable
• User’s Manual
• 1 Sensor Pack
• 1 Sensor Applicator
• 1 Alcohol wipe
• Product insert
Touchscreen
USB Port
Used to charge the Reader
and connect it to a computer.
Home Button
Test Strip Port
Insert a test strip here to use
the built-in meter.
Turns the Reader on/off
and takes you to the
Home screen from any
other screen.
The Reader is used to get glucose readings from your Sensor . It can store
approximately 90-days of glucose history and notes you enter about
activities, such as taking insulin, eating food, or exercising . This information
can help you understand how these activities affect your glucose .
DOC28687_rev-E_manual.indd 9-10
Sensor Pack
Used with the Sensor Applicator to
prepare the Sensor for use .
Sensor Applicator
Applies the Sensor to your body .
The Sensor measures and stores glucose readings when worn on your
body . It initially comes in two parts: one part is in the Sensor Pack and
the other part is in the Sensor Applicator . By following the instructions,
you prepare and apply the Sensor on the back of your
upper arm . The Sensor has a small, flexible tip that is
inserted just under the skin . The Sensor can be worn
for up to 14 days .
Sensor
Measures your glucose while on your
body (only visible after applied).
10
3/30/14 2:52 PM
The Reader Home Screen provides access to information about your
glucose and the System . You can press the Home Button to get to the
Home Screen .
Home Screen
The Sensor Glucose Readings screen appears after you use the Reader
to scan your Sensor . Your Reading includes your Current Glucose, a
Glucose Trend Arrow indicating which way your glucose is going, and a
graph of your current and stored glucose readings .
Sensor Glucose Readings
Time
Battery Level
Current time set on
the Reader.
Battery charge remaining.
Message
Add Notes
Touch for more
information.
10:23pm
Touch to add notes to the
glucose reading.
Ends in 14 days
Sensor Status
Check Glucose
Glucose Going
Low
Settings
Information about your
current Sensor.
Touch to change the
Reader’s settings.
Check
Glucose
Current Glucose
Glucose from your
latest scan.
Review
History
350
92
Glucose Trend Arrow
mg
dL
250
Touch to check your
Sensor glucose.
Review History
Touch to review information
about your past glucose
readings.
Reminder
Touch to set or change
reminders.
11
DOC28687_rev-E_manual.indd 11-12
Rapid-Acting
Insulin Note
150
Food Note
Direction your
glucose is going.
50
2pm
6pm
10pm
Glucose Graph
Graph of your current
and stored glucose
readings.
12
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FreeStyle Libre Software
FreeStyle Libre software can be used to view reports and change Reader
settings . The software is compatible with most Windows and Mac
operating systems . Go to www .FreeStyleLibre .com and follow onscreen
instructions to download and install the software .
INTENDED USE
FreeStyle Libre software is intended for use by individuals and
health care professionals to aid in the review, analysis, and
evaluation of information such as Sensor glucose readings,
blood glucose test results, blood ketone test results, and
other data uploaded from the FreeStyle Libre Flash Glucose
Monitoring System, in support of an effective diabetes health
management program .
FreeStyle Libre software is not intended for the diagnosis of
or screening for diabetes mellitus . Users should be aware that
FreeStyle Libre software is merely an information management
tool and it is therefore not intended to substitute for the
support of a health care professional . Individuals should always
consult their health care professional if they have any queries or
concerns about diabetes management .
13
DOC28687_rev-E_manual.indd 13-14
Setting up Your Reader for the First Time
Before using the System for the first time, the Reader must be set up .
Step
Action
Press the Home Button to turn on the Reader .
If prompted, use the touchscreen to select your
preferred language for the Reader . Touch OK to
continue .
Note: Use the pad of your finger . Do NOT use
your fingernail or any other object on the screen .
Set the Current Date using the arrows on the
touchscreen . Touch next to continue .
Current Date
14
June
2014
back
next
14
3/30/14 2:52 PM
Step
Action
Set the Current Time . Touch next to continue .
Current Time
12 am
00
CAUTION: It is very important to set the time
and date correctly . These values affect the
Reader data and settings .
back
Step
Action
The Reader now displays important information about two key
topics to help you use the system:
• How to understand the Glucose Trend Arrow included on
the Glucose Reading screen .
• How to return to the Home Screen from any other screen .
When you scan your Sensor
an arrow will indicate your
recent glucose trend:
next
Rising quickly
Rising
While using the Reader, press
the Home button to return to
the Home screen.
Changing slowly
Touch next to move to the
next topic . At the end of the
Reader setup, touch done to
go to the Home Screen .
Falling
Target Glucose
Range
80
back
to
140
next
mg
dL
Set your Target Glucose Range . Work with your
health care professional to determine your Target
Glucose Range . Touch next to continue .
Note: Your Target Glucose Range is displayed
on glucose graphs on the Reader and used to
calculate your Time In Target .
Falling quickly
back
next
back
done
Note: Charge the Reader if the battery level is low . Only use the USB cable
and power adapter included with the System .
15
DOC28687_rev-E_manual.indd 15-16
16
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Applying Your Sensor
Using Your Sensor
Step
CAUTIONS:
• The Sensor Pack and Sensor Applicator are packaged as a
set (separately from the Reader) and have the same Sensor
code . Check that the Sensor codes match
FreeSty
before using your Sensor Pack and Sensor
Sensor P
Applicator . Sensor Packs and Sensor
CODE XXX
Applicators with the same Sensor code
XXXXXXX
should be used together or your Sensor
glucose readings may be incorrect .
Apply Sensors only on the back of your upper
arm . Avoid areas with scars, moles, stretch marks,
or lumps .
Select an area of skin that generally stays flat
during your normal daily activities (no bending
or folding) . Choose a site that is at least 2 .5 cm
(1 inch) away from an insulin injection site . To
prevent discomfort or skin irritation, you should
select a different site other than the one most
recently used .
Clean application site with an alcohol wipe and
allow site to dry before proceeding . This helps
the Sensor stay attached to your body .
Note: The area MUST be clean and dry, or the
Sensor may not stick to the site .
YYYY/M
• Intense exercise may cause your Sensor to loosen due to
sweat or movement of the Sensor . If your Sensor comes
loose, you may get no readings or unreliable readings,
which may not match how you feel . Follow the instructions
to select an appropriate application site .
17
DOC28687_rev-E_manual.indd 17-18
Action
18
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Action
Step
Lid
Open the Sensor Pack by peeling the lid off
completely . Unscrew the cap from the Sensor
Applicator and set the cap aside .
Line up the dark mark on the Sensor Applicator
with the dark mark on the Sensor Pack . Press
firmly down on the Sensor Applicator until it
comes to a stop .
Lift the Sensor Applicator out of the Sensor Pack .
19
DOC28687_rev-E_manual.indd 19-20
Action
The Sensor Applicator is prepared and ready to
apply the Sensor .
CAUTION: The Sensor Applicator now
contains a needle . Do NOT touch inside the
Sensor Applicator or put it back into the
Sensor Pack .
CAUTION: Do NOT use if the Sensor Pack or
the Sensor Applicator seem to be damaged
or already opened . Do NOT use if past
expiration date .
Cap
Step
Place the Sensor Applicator over the prepared
site and push down firmly to apply the Sensor to
your body .
CAUTION: Do NOT push down on the Sensor
Applicator until placed over prepared site to
prevent unintended results or injury .
20
3/30/14 2:52 PM
Action
Step
Sensor
Gently pull the Sensor Applicator away from your
body . The Sensor should now be attached to your
skin .
Note: Applying the Sensor may cause bruising or
bleeding . If there is bleeding that does not stop,
remove the Sensor, and apply a new one at a
different site .
Starting Your Sensor
Action
Step
Press the Home Button to turn on the Reader .
No Active Sensor
Start New
Sensor
Make sure the Sensor is secure after application .
Put the cap back on the Sensor Applicator .
Discard the used Sensor Pack and Sensor
Applicator according to local regulations .
New Sensor
Starting Up
Sensor can be used in:
minutes
21
DOC28687_rev-E_manual.indd 21-22
Touch Start New Sensor .
10:23pm
OK
Review
History
Hold the Reader within 4 cm (1 .5 inches) of the
Sensor to scan it . This starts your Sensor . If sounds
are turned on, the Reader beeps when the Sensor
has been successfully activated . The Sensor can
be used to check your glucose after 60 minutes .
Note: If the Sensor is not successfully scanned
within 15 seconds, the Reader displays a prompt
to scan the Sensor again . Touch OK to return to
the Home Screen and touch Start New Sensor
to scan your Sensor .
22
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Checking Your Glucose
Step
Step
Action
10:23pm
Ends in 14 days
OR
Check
Glucose
Review
History
Turn the Reader on by pressing
the Home Button or touch
Check Glucose from the Home
Screen .
Action
Glucose Going
Low
350
92
mg
dL
The Reader displays your current glucose reading
along with your glucose graph and an arrow
indicating the direction your glucose is going .
250
150
50
2pm
6pm
10pm
Hold the Reader within 4 cm (1 .5 inches) of your
Sensor to scan it . Your Sensor wirelessly sends
glucose readings to the Reader . If sounds are
turned on, the Reader beeps when the Sensor
has been successfully scanned .
Note: If the Sensor is not successfully scanned within 15
seconds, the Reader displays a prompt to scan the Sensor
again . Touch OK to return to the Home Screen and touch
Check Glucose to scan your Sensor .
23
DOC28687_rev-E_manual.indd 23-24
24
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Sensor Glucose Readings
The Glucose Trend Arrow gives you an indication of the direction your
glucose is going .
Glucose is rising quickly
(more than 2 mg/dL per minute)
Glucose Going
Low
Glucose Trend Arrow
350
92
Glucose is rising
(between 1 and 2 mg/dL per minute)
mg
dL
Current Glucose
250
Target Glucose Range
150
50
2pm
6pm
10pm
Notes:
• The graph displays glucose readings up to 350 mg/dL . Glucose
readings above 350 mg/dL are displayed at 350 mg/dL .
• The symbol may appear, indicating the Reader time was changed .
Gaps in the graph may result or glucose readings may be hidden .
25
DOC28687_rev-E_manual.indd 25-26
Glucose is changing slowly
(less than 1 mg/dL per minute)
Glucose is falling
(between 1 and 2 mg/dL per minute)
Glucose is falling quickly
(more than 2 mg/dL per minute)
Note: The Glucose Trend Arrow may not always appear with your reading .
26
3/30/14 2:52 PM
The following table shows messages you may see with your glucose
readings .
Display
mg dL
350
250
High Glucose
150
50
2pm
HI
6pm
10pm
350
mg
dL
If LO appears on the Reader, your reading is lower
than 40 mg/dL . If HI appears on the Reader, your
reading is higher than 500 mg/dL . You can touch
the message button for more information . Check
your blood glucose on your finger with a test strip .
If you get a second LO or HI result, contact your
health care professional immediately .
What To Do
Glucose Going
Low
What To Do
Low Glucose
LO
Display
72
mg dL
350
Glucose Going
High
250
150
50
2pm
6pm
237
10pm
mg
If your glucose is projected to be higher than
240 mg/dL or lower than 70 mg/dL within 15
minutes, you will see a message on the screen .
You can touch the message button for more
information and set a reminder to check your
glucose .
dL
350
250
150
50
2pm
6pm
10pm
250
150
Note: If you are not sure about a message or reading, contact your
health care professional before you do anything .
50
2pm
6pm
10pm
If your glucose is higher than 240 mg/dL or lower
than 70 mg/dL, you will see a message on the
screen . You can touch the message button for
more information and set a reminder to check
your glucose .
Low Glucose
63
mg dL
350
250
High Glucose
150
50
2pm
6pm
289
10pm
mg
dL
350
250
150
50
2pm
6pm
10pm
27
DOC28687_rev-E_manual.indd 27-28
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3/30/14 2:52 PM
Step
Adding Notes
Notes can be saved with your glucose readings . You can add a note at
the time of your glucose reading or within 15 minutes after your reading
was obtained . You can track food, insulin, exercise, and any medication
you take .
Action
Add Notes
Rapid-Acting
Insulin
Long-Acting
Insulin
Food
Step
Action
OK
Enter Rapid-Acting
Insulin
OK
1/4
units
Glucose Going
Low
92
350
mg
dL
250
150
50
2pm
6pm
10pm
From the Glucose Reading screen, add notes
by touching the
symbol in the upper right
corner of the touchscreen . If you do not want to
add notes, you can press the Home Button to go
to the Home Screen or hold the Home Button to
turn the Reader off .
Note: Food
and rapid-acting insulin
notes are shown
on your glucose graphs and in your Logbook as symbols .
OK
Add Notes
Rapid-Acting
Insulin
Long-Acting
Insulin
Select the checkbox next to the notes you would
like to add . Touch the down arrow to view other
Note options .
After you check the box for food and
insulin notes, the + symbol appears
to the right of the Note . You can touch
it to add more specific information to
your note . Then touch OK .
• Insulin notes: Enter the number of
units taken .
• Food notes: Enter grams or serving
information .
Add Notes
Rapid-Acting
Insulin
Long-Acting
Insulin
Food
OK
Touch OK to save your Notes .
1/4
Food
1/4
You can review your Notes from the Logbook . See Reviewing Your History
section for more information .
29
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Remove magenta content for France .
30
3/30/14 2:52 PM
Step
Reviewing Your History
Reviewing and understanding your glucose history can be an important
tool for improving your glucose control . The Reader stores about 90 days
of information and has several ways to review your past glucose readings,
notes, and other information .
Step
Action
Action
Use the arrows to view the available options .
Review History
Logbook
Daily Graph
Daily Patterns
Average Glucose
Time In Target
1/2
Low Glucose Events
Che ck Gl ucose
Scan Sensor to check
glucose.
Press the Home Button to turn on
the Reader . Press the Home Button
again to go to the Home Screen .
Sensor Usage
IMPORTANT: Work with your health care professional
to understand your glucose history .
Touch the Review History icon .
10:23pm
Ends in 14 days
Check
Glucose
Review
History
31
DOC28687_rev-E_manual.indd 31-32
32
3/30/14 2:52 PM
The Logbook and Daily Graph show detailed information, while other
history options show summaries of information over a number of days .
Daily Graph
OK
Daily Graph
(mg/dL)
Logbook
350
250
OK
Logbook
23 Feb
10:23am
23 Feb
6:37am
22 Feb
11:09pm
143
98
108
mg/dL
Entries for each time you scanned your Sensor
or performed a blood glucose or ketone test .
If you entered Notes with a glucose reading,
the
symbol appears in that row . For more
information about the symbols, see Reader Symbols
section .
Touch the entry to review the detailed information,
including any Notes you entered . You can add or
edit (change) Notes for the most recent Logbook
entry, provided your glucose reading was within
the last 15 minutes and you have not used
FreeStyle Libre software to create reports .
33
DOC28687_rev-E_manual.indd 33-34
150
50
12
am
am
12
pm
22 Feb
Wednesday
pm
12
am
A graph of your Sensor glucose readings by day .
The graph shows your Target Glucose Range and
symbols for food or rapid-acting insulin notes you
have entered .
Notes:
• The graph displays glucose readings up to
350 mg/dL . Glucose readings above 350 mg/dL
are displayed at 350 mg/dL .
• You might see gaps in the graph during
times when you have not scanned at least
once in 8 hours .
• The symbol may appear indicating the
Reader time was changed . Gaps in the graph
may result or glucose readings may be hidden .
34
3/30/14 2:52 PM
Other History Options
Use the arrows to view information about your last 7, 14, 30, or 90 days .
OK
Time In Target
34%
Above
54%
In Target
OK
Average Glucose
Average: 119
mg/dL
152
134
121
69
12
am
am
12
pm
pm
12
am
Last 7 Days
Information about the average of your Sensor
glucose readings . The overall average for the time
is displayed above the graph . The average is also
shown for four different 6-hour periods of the day .
Readings above or below your Target Glucose
Range are orange, while readings in range are blue .
Below
12%
Target Range
80-140 mg/dL
Last 7 Days
Time In Target
OK
Low Glucose
Events
Average Glucose
Total Events: 10
OK
Daily Patterns
(mg/dL)
350
250
150
50
12
am
am
12
pm
pm
12
am
Last 7 Days
Daily Patterns
A graph showing the pattern and variability of your
Sensor glucose over a typical day . The thick black
line shows the median (midpoint) of your glucose
readings . The gray shading represents a range
(10-90 percentiles) of your Sensor readings .
Note: Daily Patterns needs at least 5 days of
glucose data .
A graph showing the percentage of time your
Sensor glucose readings were above, below, or
within your Target Glucose Range .
12
am
am
12
pm
pm
12
am
Last 7 Days
Low Glucose Events
OK
Sensor Usage
Scans Per
Day
Sensor Data
Captured
100%
Information about the number of low glucose
events measured by your Sensor . A low glucose
event is recorded when your Sensor glucose
reading is lower than 70 mg/dL for longer
than 15 minutes . The total number of events
is displayed above the graph . The bar graph
displays the low glucose events in four different
6-hour periods of the day .
Information about how often you scan your Sensor .
The Reader reports an average of how many
times you scanned your Sensor each day, and the
percentage of possible Sensor data the Reader
recorded from your scans .
Last 7 Days
Sensor Usage
35
DOC28687_rev-E_manual.indd 35-36
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3/30/14 2:52 PM
Removing Your Sensor
Step
Replacing Your Sensor
Action
Pull up the edge of the adhesive that keeps your
Sensor attached to your skin . Slowly peel away
from your skin in one motion .
Note: Any remaining adhesive residue on the
skin can be removed with warm soapy water or
isopropyl alcohol .
Discard the used Sensor according to local regulations . See
Maintenance and Disposal section .
When you are ready to apply a new Sensor, follow the
instructions in the Applying Your Sensor and Starting Your Sensor
sections . If you removed your last Sensor before 14 days of use,
you will be prompted to confirm that you would like to start a
new Sensor when you first scan it .
37
DOC28687_rev-E_manual.indd 37-38
Your Sensor automatically stops working after 14 days of wear and
must be replaced . You should also replace your Sensor if you notice any
irritation or discomfort at the application site or if the Reader reports a
problem with the Sensor currently in use . Taking action early can keep
small problems from turning into larger ones .
CAUTION: If the glucose readings from the FreeStyle Libre Flash
Glucose Monitoring System do NOT seem to match with how
you feel, check to make sure that your Sensor has not come
loose . If the Sensor tip has come out of your skin, or your Sensor
is coming loose, remove the Sensor and apply a new one .
38
3/30/14 2:52 PM
You can use Reminders to help you remember to check your glucose, take
insulin, or as a general alarm .
Set the reminder Time using the arrows on the touchscreen .
Touch save .
Action
Step
Action
Step
Using Reminders
10:23pm
From the Home Screen, touch the
Ends in 14 days
symbol .
Reminders
8:30am
12:30pm
Check
Glucose
Review
History
00:00:00
add new
Set Reminder
Type
Alarm
Touch to select which Type of reminder you want
to set: Check Glucose, Take Insulin, or Alarm .
Reminder
Repeat Daily
Time
cancel
8:30am
Alarm
XX:XX
save
Touch to select how often you want the reminder to Repeat:
Once, Daily, or Timer .
Note: You can set the reminders for a specific time (e .g . 8:30 am)
or as a timer (e .g . 3 hours from the current time) .
39
DOC28687_rev-E_manual.indd 39-40
snooze
15 min
OK
On
Off
From the Reminders screen, you can turn the
reminder On/Off or add new reminders .
Touch done to return to the Home Screen .
On
done
When reminders are On, the next reminder time
appears next to the reminder symbol on the
Home Screen .
For example,
8:30am
Your reminder comes on even if the Reader is
turned off . Touch OK to dismiss your reminder or
snooze to be reminded again in 15 minutes .
Note: Reminders will not appear if the Reader is
connected to a computer .
40
3/30/14 2:52 PM
Using the Built-in Meter
The Reader has a built-in meter that can be used to test your blood
glucose and blood ketone, or to test the meter and strips with control
solution .
WARNING: Do NOT use the built-in meter while the Reader is
connected to an electrical outlet or a computer .
41
DOC28687_rev-E_manual.indd 41-42
IMPORTANT:
• Use the Reader within the test strip operating temperature
range as blood glucose and ketone results obtained outside
the range may be less accurate .
• Use only FreeStyle Precision/FreeStyle Optium test strips .
• Use a test strip immediately after removing from its foil
packet .
• Only use a test strip once .
• Do not use expired test strips as they may cause inaccurate
results .
• Do not use a wet, bent, scratched, or damaged test strip .
• Do not use the test strip if the foil packet has a hole or is torn .
• Results from the built-in meter are shown only in your
Logbook and not in other history options .
• Refer to your lancing device instructions for use for how to
use your lancing device .
42
3/30/14 2:52 PM
Blood Glucose Testing
Step
You can use the built-in meter to check your blood glucose, whether you
are wearing a Sensor or not . You can perform a blood glucose test on
your fingertip or approved alternate site . Be sure to read the test strip
instructions for use prior to using the built-in meter .
Step
Action
Check the test strip expiration date .
D5
13758
2016/ 03
E .g . Expiration date:
March 31, 2016
Action
Wash your hands and the test site with warm
soapy water for accurate results . Thoroughly dry
your hands and the test site . To warm the site,
apply a warm dry pad or rub vigorously for a few
seconds .
Note: Avoid areas near bones and areas
with lots of hair . If you get a bruise, consider
selecting another site .
43
DOC28687_rev-E_manual.indd 43-44
Blo
CAUTION: If you think you have low
glucose (hypoglycemia) or you suffer from
hypoglycemia unawareness, test on your
fingers .
A b b ot t D i a b et es C ar e Lt d.
Ra n g e R o a d
Wi t n e y, O x o n, O X 2 9 0 Y L
M a d e in UK.
Open the foil test strip packet at the notch and
tear down to remove the test strip . Use the test
strip immediately after removing from the foil
packet .
Insert the test strip with the three black lines at
the end facing up . Push the strip in until it stops .
Apply Blood
Use your lancing device to obtain a blood drop
and apply blood to the white area at the end of
the test strip .
If sounds are turned on, the Reader beeps once
to let you know you have applied enough blood .
Note: See test strip instructions for use for
re-application instructions .
44
3/30/14 2:52 PM
Step
Action
You will see a butterfly on the screen while you
wait for your result . If sounds are turned on, the
Reader beeps once when your result is ready .
Display
What To Do
Low Glucose
LO
mg dL
High Glucose
After reviewing your result, remove and discard the used test
strip according to local regulations .
HI
mg
dL
If LO appears on the Reader, your result is lower
than 20 mg/dL . If HI appears on the Reader, your
result is higher than 500 mg/dL . You can touch the
message button for more information . Check your
blood glucose again with a test strip . If you get a
second LO or HI result, contact your health care
professional immediately .
IMPORTANT: After performing a blood glucose test,
wash your hands and the test site with soap and water
and thoroughly dry them .
If your glucose is higher than 240 mg/dL or lower
than 70 mg/dL, you will see a message on the
screen . You can touch the message button for
more information and set a reminder to check
your glucose .
Low Glucose
10:23pm
143
mg
dL
Your Blood Glucose Results
Blood glucose results are marked on the
results screen and in the Logbook with the
symbol .
63
mg
dL
High Glucose
289
mg
dL
Note: Contact your health care professional
if you have symptoms that do not match your
test results .
45
DOC28687_rev-E_manual.indd 45-46
46
3/30/14 2:52 PM
After you get your blood glucose result, you can add Notes by touching
the
symbol . If you do not want to add a Note, press the Home Button
to go to the Home Screen or hold the Home Button to turn the Reader off .
Action
Step
Check the test strip expiration date .
D5
13758
2016/ 03
E .g . Expiration date:
March 31, 2016
Blood Ketone Testing
You can use the built-in meter to check your blood ketone
(β-hydroxybutyrate) . It is important to consider doing this when:
Open the foil test strip packet at the notch and
tear down to remove the test strip . Use the test
strip immediately after removing from the foil
packet .
Action
Step
A b b ot t D i a b et es C ar e Lt d.
Ra n g e R o a d
Wi t n e y, O x o n, O X 2 9 0 Y L
M a d e in UK.
You are sick
Your glucose is higher than 240 mg/dL
You and your health care professional decide you should
Note: Be sure to read the test strip instructions for use prior to
performing a ketone test .
Blo
•
•
•
Wash your hands with warm soapy water for
accurate results . Thoroughly dry your hands .
To warm the site, apply a warm dry pad or rub
vigorously for a few seconds .
Note: Use only fingertip samples for blood
ketone testing .
47
DOC28687_rev-E_manual.indd 47-48
Note: Use only blood ketone test strips . Do not
put urine on the test strip .
Insert the test strip with the three black lines
facing up . Push the strip in until it stops .
48
3/30/14 2:52 PM
Action
Step
Apply Blood
Ketone Test
Use your lancing device to obtain a blood drop
and apply blood to the white area at the end of
the test strip .
If sounds are turned on, the Reader beeps once
to let you know you have applied enough blood .
Note: See test strip instructions for use for
re-application instructions .
Your Blood Ketone Results
Blood ketone results are marked on the results
screen and in the Logbook with the word Ketone .
10:23pm
0.4
mmol
Ketone Test
Notes:
You will see a butterfly on the screen while you
wait for your result . If sounds are turned on, the
Reader beeps once when your result is ready .
• Blood ketone is expected to be lower than 0 .6 mmol/L .
• Blood ketone may be higher when you are sick, fasting, have
exercised hard, or if glucose levels are not controlled .
• If your blood ketone result remains high or becomes higher than
1 .5 mmol/L, contact your health care professional immediately .
After reviewing your result, remove and discard the used test
strip according to local regulations .
IMPORTANT: After performing a blood ketone test,
wash your hands with soap and water and thoroughly
dry them .
49
DOC28687_rev-E_manual.indd 49-50
50
3/30/14 2:52 PM
Display
What To Do
High Ketone
1.7
mmol
If your blood ketone is high, you will see a
message on the screen . You can touch the
message button for more information .
Control Solution Testing
You should do a control solution test when you are not sure of your test
strip results and want to check that your Reader and test strips are working
properly . You can do a control solution test with a blood glucose or ketone
test strip .
IMPORTANT:
Ketone Test
• Control solution results should fall within the control
solution range printed on the test strip instructions for use .
• Do NOT use control solution past the expiration date . Discard
control solution 3 months after opening .
• The control solution range is a target range for control
High Ketone
HI
mmol
Ketone Test
If HI appears on the Reader, your ketone result is
higher than 8 mmol/L . You can touch the message
button for more information . Repeat the ketone
test with a new test strip . If you get a second
HI result, contact your health care professional
immediately .
solution only, not for your blood glucose or ketone results .
• The control solution test does not reflect your blood glucose
or ketone levels .
• Use only MediSense glucose and ketone control solution .
• Check that the LOT number printed on the test strip foil
packet and instructions for use match .
• Replace the cap securely on the bottle immediately after use .
• Do NOT add water or other liquid to the control solution .
• Contact Customer Service for information on how to obtain
control solution .
51
DOC28687_rev-E_manual.indd 51-52
Change MediSense to Optium for Australia .
52
3/30/14 2:52 PM
Action
Step
From the Home Screen, touch the Settings
symbol
. Touch Control Solution Test to do
a control solution test .
10:23pm
Ends in 14 days
Check
Glucose
Action
Step
Insert the test strip with the three black lines
facing up . Push the strip until it stops .
Review
History
Settings
Sounds
Target Range
Control Solution Test
1/3
Check the test strip expiration date .
D5
13758
2016/ 03
E .g . Expiration date:
March 31, 2016
Shake the control solution bottle to mix the
solution . Apply a drop of control solution to the
white area at the end of the test strip .
If sounds are turned on, the Reader beeps once
to let you know that you have applied enough
control solution .
You will see a butterfly on the screen while you
wait for the result . If sounds are turned on, the
Reader beeps once when the result is ready .
Open the foil test strip packet at the notch and
tear down to remove the test strip .
Blo
A b b ot t D i a b et es C ar e Lt d.
Ra n g e R o a d
Wi t n e y, O x o n, O X 2 9 0 Y L
M a d e in UK.
Apply Control Solution
53
DOC28687_rev-E_manual.indd 53-54
54
3/30/14 2:52 PM
10:23pm
100
mg
dL
Control Solution Test
Control Solution Results
Compare the control solution result to the
range printed on the test strip instructions
for use . The result on your screen should be
in this range .
Control solution results are marked on
the results screen and in the Logbook
with a
symbol .
Using the Rapid-Acting Insulin Calculator
This optional feature requires an understanding of the use of insulin .
Misuse or misunderstanding of this feature and the suggested dose
may lead to inappropriate insulin dosing . The calculator suggests
doses for rapid-acting insulin only . The calculator is only for use with
fingerstick blood glucose results from the built-in meter . You cannot
use the insulin calculator with Sensor glucose readings .
Blood Glucose Control
Solution Test
10:23pm
0.4
mmol
Note: Repeat the control solution test if the
results are outside of the range printed on
the test strip instructions for use . Stop using
the built-in meter if the control solution
results are repeatedly outside of the printed
range . Contact Customer Service .
An access code is required to set up or change the rapid-acting
insulin calculator settings . This access code is available only
to your health care professional . Work with your health care
professional to set up or change the calculator for you .
If you are not sure about the calculator’s suggested dose, you can adjust it
based on instructions from your health care professional .
Ketone Control
Solution Test
Ketone Control Solution Test
55
DOC28687_rev-E_manual.indd 55-56
56
3/30/14 2:52 PM
Step
CAUTION: The rapid-acting insulin calculator cannot account
for all the factors that may affect your insulin dose . These
include incorrectly entered data, incorrectly set date or time,
un-logged insulin, smaller or larger meals, sickness, exercise,
etc . It is important that you review your suggested dose and
account for these factors before taking insulin .
Action
Enter information about any
rapid-acting insulin you may have
forgotten to log . Touch next .
Have you forgotten
to log any rapid-acting
insulin you have taken
since X:XX?
Enter any rapidacting insulin you
have forgotten to log.
no
yes
units
If you have added a rapid-acting insulin note to a glucose result without
indicating how much insulin you took, the calculator will not be available
for up to 8 hours .
back
How long ago was
ne
thxet unlogged dose of
rapid-acting insulin?
15
minutes or less
back
Step
next
Action
10:23pm
143
mg
dL
Insulin Calculator
Test your blood glucose on your finger . Touch
Insulin Calculator from the blood glucose
results screen . You can also access the insulin
calculator by touching the calculator icon next
to Rapid-Acting Insulin from the Add Notes
screen .
57
DOC28687_rev-E_manual.indd 57-58
Notes:
• You have up to 15 minutes after testing your blood glucose to access
the calculator . If the Reader turns off or if you have navigated away
from the result screen, you can go to the Logbook and touch add or
edit notes to access the calculator from your last blood glucose entry .
• If your blood glucose result is below 60 mg/dL, the calculator is not
available .
• Do not use control solution to obtain a suggested dose .
58
3/30/14 2:52 PM
Step
Action
If your calculator was programmed with Easy
Setup, touch the meal you plan to eat now . Touch
next .
Breakfast
Lunch
Step
Action
Suggested Dose
Adjust if needed
12u
Dinner
User change:
+2.0
No meal
back
next
Or
Enter Carbs
20
grams
back
If your calculator was programmed with
Advanced Setup, enter the grams of
carbohydrates or servings of carbohydrates
you plan to eat now . Touch done .
log dose
Insulin to cover your meal
Dose Details
For breakfast
For 143 mg/dL
Active insulin
User change
done
Or
OK
+2
-1
+2
Total 12u
Enter Servings
2.0
servings
= 30g carbs
back
back
Review your suggested dose . If needed, use the
arrow buttons to adjust your suggested dose for
any planned activity, a smaller or larger meal,
sickness, etc . Touch the
symbol to see details
of what is included in your suggested dose .
Insulin to correct for your current
glucose level
Insulin remaining in your body
A change you have made to the
suggested insulin dose
1/2
Your total suggested dose
done
Remove magenta content for France .
59
DOC28687_rev-E_manual.indd 59-60
60
3/30/14 2:52 PM
Step
Action
Touch log dose to save to your Logbook and take your dose .
Your dose is only saved to the Logbook if you touch log dose .
10:23pm
Ends in 3 days
Check
Glucose
CAUTION: It is important to log all your rapid-acting
insulin doses so your Reader can account for active
insulin when calculating your suggested doses . Failure
to log all your rapid-acting insulin doses may result in a
suggested dose that is too high .
Review
History
8:30am
If your health care professional turned on the Active
Insulin feature, the
symbol may appear on your
Home Screen . It shows an estimate of the amount of
rapid-acting insulin left in your body and how much
longer it may be active . Touch the
symbol to see
more information about the remaining rapid-acting
insulin from your logged doses .
Estimated percentage of active insulin remaining in your body
Note: The total dose is rounded up or down to the nearest
whole number unless your health care professional has
changed your Reader to count by half unit steps .
No symbol
100-87%
61
DOC28687_rev-E_manual.indd 61-62
86-62%
61-37%
36-12%
11-1%
0%
62
3/30/14 2:52 PM
Charging the Reader
A fully charged Reader battery should last up to 7 days . Your battery life
may vary depending on your usage . A Low Battery message accompanies
your result when you have enough charge remaining for about one day of
use .
Changing the Reader Settings
You can go to the Settings menu to change many settings on the Reader,
like Time & Date or Sounds . The Settings menu is also where you go to do
a Control Solution Test or to check the System Status .
Action
Step
Plug the included USB cable into an electrical
outlet using the included power adapter . Then,
plug the other end of the USB cable into the USB
port on the Reader .
CAUTION: Be sure to select a location for
charging that allows the power adapter to be
easily unplugged .
Charging
To get to the Settings menu, touch the Settings
symbol
on the Home Screen .
10:23pm
Ends in 14 days
Check
Glucose
Review
History
Settings
Sounds
Target Range
Notes:
• You must charge the Reader when the battery
is low
to keep using the Reader .
• To fully charge the battery, charge the Reader
for at least 3 hours .
• Only use the USB cable and power adapter
included with the system .
• Fully charge your Reader before storing it for
more than 3 months .
63
DOC28687_rev-E_manual.indd 63-64
Control Solution Test
1/3
64
3/30/14 2:52 PM
Step
Action
Touch the setting you want to change:
Sounds – Set tones and vibrations
Target Range – Set range displayed on Reader
glucose graphs
Control Solution Test – Perform a Control Solution test
Time & Date – Change the Time or Date
Language – Change the language on the Reader (option only
available on Readers with multiple languages)
System Status – Check Reader information and performance
• View System Information: The Reader will display information
about your System including:
- Current Sensor end date and time
- Reader serial number and version number
- Serial numbers of most recent Sensors (up to three)
- Sensor version for most recent Sensor
- Number of Sensors that have been used with Reader
- Number of tests that have been performed using test strips
65
DOC28687_rev-E_manual.indd 65-66
Step
(cont.)
Action
• View Event Logs: A list of events recorded by the
Reader, which may be used by Customer Service to help
troubleshoot your System
• Perform a Reader Test: The Reader Test will perform internal
diagnostics and allow you to check that the Display is
showing all pixels, Sounds (including both tones and
vibrations) are working, and the Touchscreen is responding
when touched
Calculator Settings – Review the currently programmed
settings (option only available if your health care professional
has activated your insulin calculator)
Reader Basics – Review the information screens shown
during the Reader setup
Professional Options – Set by health care professionals only
Touch OK when you are done .
66
3/30/14 2:52 PM
Living With Your FreeStyle Libre System
Your FreeStyle Libre Flash Glucose Monitoring System can be used during
a wide variety of activities .
Activity
Bathing,
Showering, and
Swimming
Sleeping
What You Need To Know
The Reader is not water-resistant and should
NEVER be submerged in water or other liquid .
Your Sensor is water-resistant and can be worn
while bathing, showering, or swimming .
Note: Do NOT take your Sensor deeper than
1 meter (3 feet) or immerse it longer than 30
minutes in water .
Your Sensor should not interfere with your sleep .
It is recommended that you scan your Sensor
before going to sleep and when you wake up
because your Sensor holds 8 hours of data at a
time .
If you have reminders set to go off while you are
sleeping, place the Reader nearby .
67
DOC28687_rev-E_manual.indd 67-68
Activity
Traveling by Air
What You Need To Know
Check with the airline prior to departure as rules
and regulations may change without notice .
Follow these guidelines when traveling:
• Notify security personnel of the presence of the
device when going through security systems .
• Do not scan your Sensor or power on the Reader
using the Home Button while flying, if restricted
by flight regulations . You may insert a strip to
perform a blood glucose or ketone test .
Note: If you are changing time zones, you can
change the time and date settings on the Reader
by touching the Settings symbol
from the
Home Screen, then Time & Date . Changing
the time and date affects the graphs, statistics,
and settings programmed by time of day . The
symbol may appear on your glucose graph
indicating the Reader time was changed . Gaps in
the graph may result or glucose readings may be
hidden .
68
3/30/14 2:52 PM
Maintenance and Disposal
Cleaning
You may clean the Reader using a cloth dampened with a mixture of
1 part household bleach to 9 parts water . Gently wipe the exterior of
the Reader and allow to air dry .
CAUTION: Do NOT place the Reader in water or other liquids .
Avoid getting dust, dirt, blood, control solution, water, or any
other substance in the test strip or USB ports .
Maintenance
The FreeStyle Libre Flash Glucose Monitoring System has no serviceable
parts .
Disposal
This product should be disposed of in accordance with all applicable local
regulations related to the disposal of electronic equipment, batteries,
sharps, and materials potentially exposed to body fluids .
Troubleshooting
This section lists problems or observations that you may have, the possible
cause(s), and recommended actions . If the Reader experiences an error, a
message will appear on the screen with directions to resolve the error .
Reader Does Not Power On
Problem
Reader does not
power on after
you press the
Home Button or
insert a test strip .
What It May Mean
Reader battery is
too low .
What To Do
Charge the Reader .
Reader is outside of Move the Reader to a
its operating
temperature between
temperature range . 10 °C and 45 °C and then
try to power it on .
Contact Customer Service for further information on the appropriate
disposal of system components .
If the Reader still does not power on after trying these steps, contact
Customer Service .
69
DOC28687_rev-E_manual.indd 69-70
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Problems at the Sensor Application Site
Problem
What It May Mean
What To Do
The Sensor is
not sticking
to your skin .
The site is not free
of dirt, oil, hair, or
sweat .
1 . Remove the Sensor .
2 . Consider shaving and/or
cleaning the site with soap
and water .
3 . Follow the instructions in
Applying and Starting Your
Sensor sections .
Skin irritation
at the Sensor
application
site .
Seams or other
constrictive clothing
or accessories
causing friction at
the site .
Ensure that nothing rubs on the
site .
You may be sensitive
to the adhesive
material .
If the irritation is where the
adhesive touches skin, contact
your health care professional to
identify the best solution .
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DOC28687_rev-E_manual.indd 71-72
Problems Starting Your Sensor or Receiving Sensor
Readings
Display
What It May Mean
What To Do
New Sensor
Starting Up
Sensor is not ready
to read glucose .
Wait until the 60 minute Sensor
start-up period has completed .
Scan
Timeout
The Reader is not
held close enough
to the Sensor .
Hold the Reader within
4 cm (1 .5 inches) of the Sensor .
Bring the screen of the Reader
close to the Sensor .
Sensor
Ended
The Sensor life has
ended .
Apply and start a new Sensor .
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Display
What It May Mean
What To Do
Display
New Sensor
Found
You scanned a new
Sensor before your
previous Sensor
ended .
Your Reader can only be used
with one Sensor at a time . If
you start a new Sensor, you will
no longer be able to scan your
old Sensor . If you would like to
begin using the new Sensor,
select “Yes” .
Glucose
Reading
Unavailable
Your Sensor is too
hot or too cold .
Move to a location where the
temperature is appropriate and
scan again in a few minutes .
Sensor
Already in
Use
The Sensor was
started by another
Reader .
A Sensor can only be scanned
by the Reader that started it .
Scan the Sensor again with the
Reader that started it . Or, apply
and start a new Sensor .
Check Sensor
The sensor tip may
not be under your
skin .
Try to start your Sensor again . If
Reader displays “Check Sensor”
again, your Sensor was not
applied properly . Apply and
start a new Sensor .
Replace
Sensor
The System has
detected a problem
with your Sensor .
Apply and start a new Sensor .
Scan Error
Sensor Error
The Reader was
unable to
communicate with
the Sensor .
Try scanning again .
Note: You may need to move
away from potential sources of
electromagnetic interference .
The System is
unable to provide a
glucose reading .
Scan again in 10 minutes .
73
DOC28687_rev-E_manual.indd 73-74
What It May Mean
What To Do
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Blood Glucose or Ketone Error Messages
Error
Message
E-1
E-2
What It May Mean
The temperature is
too hot or too cold
for the Reader to
work correctly .
Reader error .
75
DOC28687_rev-E_manual.indd 75-76
Error
Message
What It May Mean
What To Do
E-3
Blood drop is too
small .
or
Incorrect test
procedure .
or
There may be a
problem with the test
strip .
1 . Review the testing
instructions .
2 . Repeat the test using a new
test strip .
3 . If the error reappears, contact
Customer Service .
E-4
The blood glucose
level may be too high
to be read by the
system .
or
There may be a
problem with the test
strip .
1 . Repeat the test using a new
test strip .
2 . If the error reappears, contact
your health care professional
immediately .
What To Do
1 . Move the Reader and test
strips to a location where the
temperature is within the test
strip operating range . (See
test strip instructions for use
for the appropriate range) .
2 . Wait for the Reader and test
strips to adjust to the new
temperature .
3 . Repeat the test using a new
test strip .
4 . If the error reappears, contact
Customer Service .
1 . Turn off the Reader .
2 . Repeat the test using a new
test strip .
3 . If the error reappears, contact
Customer Service .
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Error
Message
What It May Mean
What To Do
Error
Message
E-5
Blood was applied
to the test strip too
soon .
1 . Review the testing
instructions .
2 . Repeat the test using a new
test strip .
3 . If the error reappears, contact
Customer Service .
E-6
The test strip may not
be compatible with
the Reader .
1 . Check that you are using
the correct test strip for
the Reader . (See test strip
instructions for use to verify
your strip is compatible with
the Reader) .
2 . Repeat the test using a test
strip for use with your Reader .
3 . If the error reappears, contact
Customer Service .
77
DOC28687_rev-E_manual.indd 77-78
What It May Mean
What To Do
E-7
Test strip may be
damaged, used, or
the Reader does not
recognize it .
1 . Check that you are using
the correct test strip for
the Reader . (See test strip
instructions for use to verify
your strip is compatible with
the Reader) .
2 . Repeat the test using a test
strip for use with your Reader .
3 . If the error reappears, contact
Customer Service .
E-9
Reader error .
1 . Turn off the Reader .
2 . Repeat the test using a new
test strip .
3 . If the error reappears, contact
Customer Service .
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Problems Checking Your Blood Glucose or Ketone
Problem
What It May Mean
What To Do
The Reader
does not
start a
test after
inserting a
test strip .
Test strip is not
inserted correctly
or not inserted fully
into the strip port .
1 . With the 3 black lines facing
up, insert the test strip into
the strip port until it stops .
2 . If the Reader still does not
start a test, contact Customer
Service .
Reader battery is too
low .
Charge the Reader .
The test strip is
damaged, used, or
unrecognizable by
the Reader .
Insert a new FreeStyle Precision/
FreeStyle Optium test strip .
Reader is outside of
its operating
temperature range .
Move the Reader to a
temperature between 10 °C and
45 °C and then try to power it
on .
Reader is in a power
saving mode .
Press the Home Button then
insert a test strip .
79
DOC28687_rev-E_manual.indd 79-80
Problem
The test
does not
start after
applying
the blood
sample .
What It May Mean
What To Do
Blood sample is too
small .
1 . See test strip instructions
for use for re-application
instructions .
2 . Repeat the test using a new
test strip .
3 . If the test still does not start,
contact Customer Service .
Sample applied after
the Reader turned
off .
1 . Review the testing
instructions .
2 . Repeat the test using a new
test strip .
3 . If the test still does not start,
contact Customer Service .
Problem with
Reader or test strip .
1 . Repeat the test using a new
test strip .
2 . If the test still does not start,
contact Customer Service .
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System Status
System Info
Reader Test
Event Log
OK
If you think the Reader is not working properly, you
can check the Reader by performing a Reader Test .
Touch the Options symbol
from the Home
Screen, select System Status and then select
Reader Test .
Note: The Reader Test will perform internal
diagnostics and will allow you to check that the
display, sounds, and touchscreen are working
properly .
Professional Options
This section is only meant for health care professionals . It describes the
access code-protected features of the Reader . Health care professionals
can change dose increments or set up the insulin calculator .
System Status
Enter Code to Unlock
Calculator Settings
cancel
done
Reader Basics
Professional Options
Professional
Options
OK
From the Home Screen, touch
the Settings symbol
. Scroll
down using the arrows and touch
Professional Options . Enter the
access code .
Professional Options
Perform a Reader Test
Dose Increment
Insulin Calculator
Customer Service
Customer Service is available to answer any questions you may have about
your FreeStyle Libre Flash Glucose Monitoring System . Please go the back
cover of this manual for your Customer Service phone number .
81
DOC28687_rev-E_manual.indd 81-82
Note: If you are a health care professional, contact Customer Service for
more information .
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Professional Options
Setting up the Insulin Calculator
You can set the insulin dose increments to either 1 .0 or 0 .5 units for use
with the Rapid-acting insulin calculator and insulin notes .
The insulin calculator can help your patients calculate their rapid-acting
insulin doses based on meal and fingerstick blood glucose level
information . From the Professional Options screen, select Insulin
Calculator .
Dose Increment
1 unit
0.5 unit
done
From the Professional Options screen, select
Dose Increment . Then choose 1 unit or 0.5 unit .
Touch done .
CAUTION: This feature requires an understanding of the use
of insulin . Misuse or misunderstanding of this feature and the
suggested dose may lead to inappropriate insulin dosing . The
calculator suggests doses for rapid-acting insulin only .
Professional Options
Changing Dose Increments
Complete the setup to store your patient’s individual insulin settings in
the Reader . The calculator uses the fingerstick blood glucose results, meal
information and the stored settings to calculate a suggested insulin dose
based on this formula:
Blood glucose
correction
(if needed)
83
DOC28687_rev-E_manual.indd 83-84
Meal | Carbohydrate
Intake
Active Insulin
(if present)
Total
= suggested
dose
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Professional Options
You must complete all of the steps in the insulin calculator setup in order
for the patient to use the calculator . When you have finished setting up
the insulin calculator, you can review the settings to make sure they are
correct for your patient . You can also review settings at a later time . Touch
the Settings symbol
from the Home Screen, then select Calculator
Settings .
Easy Setup of the Insulin Calculator
Action
Step
Easy
For patients who start with a
fixed dose of rapid-acting
insulin at meals.
back
next
next
Correction Target
70
back
DOC28687_rev-E_manual.indd 85-86
Enter the meal-time rapid-acting insulin doses .
Touch next after each entry .
units of insulin
back
85
Breakfast
IMPORTANT: If the time on the Reader is wrong, this may lead
to an incorrect suggested dose .
Remove magenta content for France .
Choose the Easy option on the slide bar and
touch next .
Note: You need to know your patient’s
meal-time insulin doses, target glucose range,
and correction factor .
Choose Setup Option
Professional Options
You can set up the insulin calculator using the Easy or Advanced
settings . The Easy Setup is for patients who start with a fixed dose of
rapid-acting insulin for meals . The Advanced Setup is for patients who
count carbohydrates (in grams or servings) to adjust their rapid-acting
insulin dose for meals .
to
130
next
mg
dL
Enter the blood glucose Correction Target . This
is the desired target range for blood glucose
values before meals . Touch next .
Note: If you just want to set one target instead
of a range, set both the low and high values to
the same number .
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Professional Options
Correction Factor
1 u insulin for
10
back
mg
dL
next
Enter the Correction Factor (for example: if 1 unit
of insulin lowers blood glucose 50 mg/dL, then the
correction factor is 50) . If the blood glucose value
is outside the blood glucose target, the calculator
will use the correction target and factor to
calculate a correction dose .
Notes:
• If your patient does not take correction insulin, touch the
down arrow to go below 1 to set “No correction insulin”. If you
set “No correction insulin”, the calculator only includes meal
doses . Additionally, active insulin is not tracked or calculated .
• The calculator corrects a blood glucose value to the single
target or the average of the target range .
• The calculator will not suggest a dose that is estimated to
drop the blood glucose below the lower end of the target
range or single target .
Touch next . Then touch done to complete the setup . You can
now review the calculator settings . Touch OK when done .
87
DOC28687_rev-E_manual.indd 87-88
Notes about the Easy Option:
• The calculator estimates the amount of rapid-acting insulin still in the
body and how much longer it may be active (if the correction factor is
set to “no correction insulin”, active insulin is not calculated) . The active
insulin estimate is based on a 4-hour insulin duration calculated from
the time and amount of the last logged rapid-acting insulin dose .
• Both meal and correction doses are included in the active insulin
tracking .
• Insulin doses calculated 0-2 hours after a previously logged dose
will only include a meal dose . Active insulin will not be subtracted
from the meal or carbohydrate dose, and a correction dose will not
be included even if the blood glucose is outside the target . During
this time period, the previous dose has not reached peak action and
additional correction doses, referred to as `insulin stacking’, may
result in hypoglycemia .
• Insulin doses calculated 2-4 hours after a previously logged dose will
have active insulin subtracted from the suggested dose .
• All previously injected rapid-acting insulin should be logged to ensure
accurate active insulin tracking and calculations .
Professional Options
Action
Step
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Professional Options
Advanced Setup of the Insulin Calculator
This page can be used to record insulin calculator settings .
Breakfast
Dose
Lunch
Dose
Dinner
Dose
units of insulin
units of insulin
units of insulin
0-50
0-50
0-50
Correction Target
mg/dL
mg/dL
70-180
70-180
This is the insulin
required to cover food .
Action
Step
Choose Setup Option
Advanced
For patients who count carbs (in
gra ms or servings) to adjust
their rapid-acting insulin dose
at meals.
back
next
This is the desired range
for before meal blood
glucose .
Enter food by:
Grams of carbs
mg/dL
This is the estimated
amount blood glucose
will drop by taking one
unit of insulin .
back
Touch to select how meal/carbohydrate
information will be entered . Touch next .
For Grams of carbs, go to Step 3 .
For Servings, go to Step 4 .
Servings
Correction Factor
1 unit of insulin for
Choose the Advanced option on the slide bar
and touch next .
Note: You need to know your patient’s mealtime insulin settings, target glucose range,
correction factor, and insulin duration .
Professional Options
Calculator Settings - Easy Option
next
1-99 (or No Correction)
For France: remove Step 2 & 4 and magenta content in Step 3 . Renumber steps .
Changes to these settings can only be made by a health care professional .
89
DOC28687_rev-E_manual.indd 89-90
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Professional Options
Carbohydrate Ratio
If you chose to enter Grams of carbs in Step 2:
The rapid-acting insulin dose suggestion is based
on grams of carbs .
1 u insulin for
10
Action
Step
Servings Definition
10.0
grams carbs
Optional:
by time
of day
back
next
Carbohydrate ratio
1 unit insulin for:
grams carbs
Enter the Carbohydrate Ratio (1 unit of rapidacting insulin for
grams of carbs) . Touch
next when complete .
15g
midday
20g
eveniCnagrbohydrate
Ratio
back
done
OK
1 u insulin for
10
grams carbs
Note: If you want to set different
carbohydrate ratios for different times
of day, touch the option by time of day .
Touch each time period to change the
carbohydrate ratio . Touch OK after each
entry to save . Touch done .
back
For 1 serving:
1.5
units insulin
4:00 AM - 9:59 AM (04:00 - 09:59)
10:00 AM - 3:59 PM (10:00 - 15:59)
4:00 PM - 9:59 PM (16:00 - 21:59)
10:00 PM - 3:59 AM (22:00 - 03:59)
91
DOC28687_rev-E_manual.indd 91-92
next
Enter the Servings Definition (10 to 15
grams of carbs) and touch next . Enter the
Servings Ratio (
units of rapid-acting
insulin per 1 serving) . Touch next when
complete .
3 u ins
midday
4 u ins
evening
back
Morning
Midday
Evening
Night
back
2 u ins
morning
Go to Step 5 .
Time of day blocks can not be adjusted . They correspond to the
following times:
Optional:
by time
of day
Servings ratio
for 1 serving:
3 u ins
night
Morning:
4am to 10am
Servings Ratio
next
10g
morning
15g
night
If you chose to enter Servings in Step 2: The
rapid-acting insulin dose suggestion is based on
servings .
1 serving =
Professional Options
Action
Step
Servings Ratio
done
OK
Note: If you want to set different serving
ratios for different times of day, touch the
option by time of day . Touch each time
period to change the servings ratio . Touch
OK after each entry to save . Touch done .
For 1 serving:
units insulin
Morning:
4am to 10am
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Professional Options
How does your
patient correct their
glucose?
Select how you want your patient to correct their
glucose . Touch next .
Action
Step
1 u insulin for
10
To a single target
Correction factor
1 u insulin fboarc:k
next
mg
dL
by time
of day
Optional:
To a target range
back
Correction Factor
next
10 mg/dL
morning
Enter the Correction Target value or range . This
Correction Target
is the desired target value or range for blood
glucose values before meals . Touch next when
complete .
100
mg/dL
Optional:
back
by time
of day
100
morning
110
midday
100
evening
back
20 mg/dL
midday
15 mg/dL
evening
back
done
Correction Factor
Corrdeocn
tieon Target
OK
100
mg/dL
Note: If the Correction Target is
based on time of day, touch the
option by time of day . Touch each
time period to change the correction
target for that period . Touch OK after
each entry to save . Touch done .
OK
1 u insulin for
10
Corre
ncetxio
t n Target
in mg/dL:
120
night
20 mg/dL
night
Enter the Correction Factor (for example: if 1
unit of insulin lowers blood glucose 50 mg/dL,
then the correction factor is 50) . If the blood
glucose reading is outside the blood glucose
target, the calculator will use the correction
target and factor to calculate a correction dose .
Touch next when complete .
Morning:
4am to 10am
mg
dL
Professional Options
Action
Step
Notes:
• If the Correction Factor is based on time of
day, touch the option by time of day . Touch
each time period to change the correction
factor for that period . Touch OK after each
entry to save . Touch done .
• The calculator corrects a blood glucose value
to the single target or the average of the
target range .
• The calculator will not suggest a dose that is
estimated to drop the blood glucose below
the lower end of the target range or single
target .
Morning:
4am to 10am
93
DOC28687_rev-E_manual.indd 93-94
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Professional Options
Insulin Duration
4:30
Enter the Insulin Duration . This is the amount of
time that rapid-acting insulin remains active in
the patient’s body .
Do you want the
Active Insulin symbol
to be displayed on the
Home Screen?
Yes
hrs:min
Touch next .
back
Action
Step
next
No
back
IMPORTANT: In general, the insulin duration for rapidacting insulin ranges from 3-5 hours, and can vary for
each person1 . The Reader allows an insulin duration
from 3-8 hours .
95
DOC28687_rev-E_manual.indd 95-96
next
Select whether or not to show the Active Insulin
symbol
on the Home Screen .
This symbol shows an estimate of the amount
of rapid-acting insulin still in the body and how
much longer it may be active . If you select “No”,
active insulin is still included in the suggested
dose calculation .
Professional Options
Action
Step
Touch next . Then touch done to complete the
setup . You can now review the calculator settings .
Touch OK when done .
Product Inserts: HumaLog®, NovoLog®, Apidra®
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Active insulin curvilinear model
100
90
80
% active insulin
Professional Options
This graph shows how the insulin calculator estimates the amount of
active insulin as a function of logged insulin dose and insulin duration
over time . It also shows the relationship between the
symbol and
amount of active insulin .
Professional Options
Notes about the Advanced Option:
• The calculator estimates the amount of rapid-acting insulin still in
the body and how much longer it may be active . The active insulin
estimate is calculated from the set insulin duration, the time, and
amount of the last logged rapid-acting insulin dose .
• Both meal and correction doses are included in the active insulin
tracking .
• Insulin doses calculated 0-2 hours after a previously logged dose
will only include a meal dose . Active insulin will not be subtracted
from the meal or carbohydrate dose, and a correction dose will not
be included even if the blood glucose is outside the target . During
this time period, the previous dose has not reached peak action and
additional correction doses, referred to as `insulin stacking’, may result
in hypoglycemia .
• Insulin doses calculated between 2 hours and the set insulin duration
will have active insulin subtracted from the suggested dose (for
example if insulin duration is set at 5 hours, active insulin will be
subtracted from doses calculated between 2-5 hours) .
• All previously injected rapid-acting insulin should be logged to ensure
accurate active insulin tracking and calculations .
70
60
50
40
30
20
10
10
20
30
40
50
60
70
80
90
100
% insulin duration
Adapted from Mudaliar et al . Diabetes Care, Volume 22(9), Sept 1999, pp 1501-1506
97
DOC28687_rev-E_manual.indd 97-98
98
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Professional Options
This page can be used to record insulin calculator settings .
This is the number of grams of
carbs that one unit of rapid-acting
insulin will cover OR the number
of units of rapid-acting insulin that
will cover one serving . (Option to
enter by time of day .)
Carbohydrate
Ratio
1 unit of insulin for
OR
grams of carbs
1-50
Servings
Definition
Servings Ratio
For 1 serving take
grams of carbs
10-15
units of insulin
0.5-15
mg/dL
1-99
Insulin Duration
Insulin is active in the body for
This is the estimated amount blood
glucose will drop by taking one
unit of insulin . (Option to enter by
time of day .)
This is the amount of time that
a dose of rapid-acting insulin
remains active in the body .
hours:mins
3-8
This is the desired target or range
for before meal blood glucose .
(Option to enter by time of day .)
Correction
Target
OR
mg/dL
70-180
Correction Factor
1 unit of insulin for
Professional Options
Calculator Settings - Advanced Option
Active Insulin feature?
Correction
Target Range
Yes
No
to
mg/dL
70-180
mg/dL
70-180
Changes to these settings can only be made by a health care professional .
99
DOC28687_rev-E_manual.indd 99-100
Remove magenta content for France .
100
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Professional Options
Changing the Insulin Calculator Settings
Action
Step
System Status
Calculator Settings
From the Home Screen, touch the Settings
symbol
. Scroll down using the arrows and
touch Professional Options . Enter the access
code . Touch Insulin Calculator .
Reader Basics
Professional Options
Calculator Settings
Turn Off Calculator
Change Calculator
Settings
back
Touch Turn Off Calculator to turn off the insulin
calculator or Change Calculator Settings to
change the insulin calculator settings .
Note: If you turn off the insulin calculator,
your patient will no longer see the calculator
button after a blood glucose test . You can turn
the calculator back on by repeating the insulin
calculator setup .
101
DOC28687_rev-E_manual.indd 101-102
System Specifications
See test strip and control solution instructions for use for additional
specifications .
Sensor Specifications
Sensor glucose assay
method
Amperometric electrochemical sensor
Sensor glucose reading
range
40 to 500 mg/dL
Sensor size
5 mm height and 35 mm diameter
Sensor weight
5 grams
Sensor power source
One silver oxide battery
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Reader Specifications
Sensor life
Up to 14 days
Blood glucose assay
range
20 to 500 mg/dL
Sensor memory
8 hours (glucose readings stored every
15 minutes)
Blood ketone assay range
0 .0 to 8 .0 mmol/L
Reader size
95 mm x 60 mm x 16 mm
Reader weight
65 grams
Reader power source
One lithium-ion rechargeable battery
Operating temperature
10 °C to 45 °C
Sensor Applicator and
Sensor Pack storage
temperature
4 °C to 30 °C
Operating and storage
relative humidity
10-90%, non-condensing
Reader battery life
7 days of typical use
Reader memory
90 days of typical use
Sensor water resistance
IP27: Can withstand immersion into
one meter (3 ft) of water for up to 30
minutes
Reader operating
temperature
10 °C to 45 °C
Reader storage
temperature
-20 °C to 60 °C
Operating and storage
altitude
103
DOC28687_rev-E_manual.indd 103-104
-381 meters (-1,250 ft) to 3,048 meters
(10,000 ft)
104
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Operating and storage
relative humidity
10-90%, non-condensing
Reader moisture
protection
Keep dry
Operating and storage
altitude
-381 meters (-1,250 ft) to 3,048 meters
(10,000 ft)
Reader display timeout
60 seconds (120 seconds when test
strip is inserted)
Radio Frequency
13 .56 MHz
Data port
Micro USB
Minimum Computer
Requirements
System must only be used with
EN60950-1 rated computers
Mean service life
3 years of typical use
Power Adapter
USB Cable
105
DOC28687_rev-E_manual.indd 106
Rapid-Acting Insulin Calculator Specifications
Parameter
Unit
Range or Value
Correction target
mg/dL
70 to 180
Carbohydrate ratio
1 unit per X grams
of carbs
1 to 50
Servings ratio
Units of insulin per
serving
0 .5 to 15
Servings definition
Grams of carbs
10 to 15
Abbott Diabetes Care
PRT25612 (UK plug)
PRT25613 (EU Plug)
PRT25847 (Australia plug)
PRT25611 (Canada plug)
Operating temperature: 10 °C to 40 °C
Mealtime insulin doses
(breakfast, lunch, dinner)
Units of insulin
0 to 50
Correction factor
1 unit per X mg/dL
1 to 99
Abbott Diabetes Care PRT21373
Length: 94 cm (37 inches)
Insulin duration
(duration of insulin action)
Hours
Easy: 4
Advanced: 3 to 8
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Parameter
Unit
Range or Value
Labeling Symbols
Dose increments
Units of insulin
0 .5 or 1
Consult instructions for
use
Use-by date
Maximum insulin dose
Units of insulin
50
Temperature limit
Catalog number
Manufacturer
Serial number
CE Mark
Do not use if package is
damaged
Batch code
Keep dry
Type BF applied part
Non-ionizing radiation
Sensor code
Caution
Do not re-use
Sterilized using
irradiation
CODE
Remove magenta content for France .
107
DOC28687_rev-E_manual.indd 107-108
This product must not be disposed of via municipal waste
collection . Separate collection for electrical and electronic
equipment waste per Directive 2012/19/EC in the European
Union is required . Contact the manufacturer for details .
May or may not be present or may vary per RA requirements .
108
3/30/14 2:53 PM
Electromagnetic Compatibility
Include for Canada
• The System needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual.
• Portable and mobile RF communications equipment can affect the System.
• The use of accessories, transducers and cables other than those specified by Abbott Diabetes Care
may result in increased EMISSIONS or decreased IMMUNITY of the System.
• The System should not be used adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, the System should be observed to verify normal operation in the
configuration in which it will be used.
• This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation.
• Changes or modifications not approved by Abbott could void the user’s authority to operate the
equipment.
109
DOC28687_rev-E_manual.indd 109-110
Guidance and manufacturer’s declaration –
electromagnetic emissions
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic
environment – guidance
RF emissions
CISPR 11
Group 1
The System uses RF energy only
for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Complies
The System is suitable for use
in all establishments, including
domestic establishments and
those directly connected to the
public low voltage power supply
network that supplies buildings
used for domestic purposes.
110
3/30/14 2:53 PM
Guidance and manufacturer’s declaration –
electromagnetic immunity
The System is intended for use in the electromagnetic environment specified below. The customer or
the user of the System should assure that it is used in such an environment.
IMMUNITY
test
IEC 60601
test level
Compliance
Level
Electromagnetic
environment – guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for
power supply
lines
± 1 kV for input/
output lines
111
DOC28687_rev-E_manual.indd 111-112
± 2 kV for
power supply
lines
± 1 kV for input/
output lines
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
IMMUNITY
test
IEC 60601
test level
Compliance
Level
Electromagnetic
environment – guidance
Surge
IEC 61000-4-5
±1 kV
differential
mode
±2 kV common
mode
±1 kV
differential
mode
±2 kV common
mode
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT (>95
% dip in UT) for
0.5 cycle
40 % UT (60 %
dip in UT) for 5
cycles
70 % UT (30 %
dip in UT) for 25
cycles
<5 % UT
(>95 % dip
in UT) for 5
seconds
<5 % UT (>95
% dip in UT) for
0.5 cycle
40 % UT (60 %
dip in UT) for 5
cycles
70 % UT (30 %
dip in UT) for 25
cycles
<5 % UT
(>95 % dip
in UT) for 5
seconds
Mains power quality should be that
of a typical domestic, commercial,
or hospital environment. If the user
of the System requires continued
operation during power mains
interruptions, it is recommended
that the System be powered from an
uninterruptible power supply or a
battery.
112
3/30/14 2:53 PM
IMMUNITY
test
IEC 60601
test level
Compliance
Level
Electromagnetic
environment – guidance
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
domestic, commercial, or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
IMMUNITY
test
Conducted RF
IEC 61000-4-6
IEC 60601
test level
3 Vrms
150 kHz to
80 MHz
Compliance
Level
Electromagnetic
environment – guidance
3 Vrms
Portable and mobile RF
communications equipment should
be used no closer to any part of the
System, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation
distance
d = 1.2
113
DOC28687_rev-E_manual.indd 113-114
114
3/30/14 2:53 PM
IMMUNITY
test
Radiated RF
IEC 61000-4-3
IEC 60601
test level
3 V/m
80 MHz to
2.5 GHz
Compliance
Level
3 V/m
Electromagnetic
environment – guidance
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the System is used exceeds the applicable RF compliance level
above, the System should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation
distance
d = 1.2
80 MHz to 800 MHz
d = 2.3
800 MHz to 2.5 GHz
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should
be less than the compliance level in each frequency range.b
Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
115
DOC28687_rev-E_manual.indd 115-116
116
3/30/14 2:53 PM
Recommended separation distances between portable
and mobile RF communications equipment and the
System
The System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the System as recommended below, according to the maximum output power of
the communications equipment.
Rated maximum
output power of
transmitter
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Separation distance according to frequency of transmitter
150 kHz to
80 MHz
80 MHz to
800 MHz
800 MHz to
2.5 GHz
d = 1.2
d = 1.2
d = 2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
117
DOC28687_rev-E_manual.indd 117-118
118
3/30/14 2:53 PM
Hereby, Abbott Diabetes Care Ltd, declares that the FreeStyle Libre
Flash Glucose Monitoring System is in compliance with the essential
requirements and other relevant provisions of the R&TTE Directive . A
copy of the original declaration of conformity may be obtained from
Abbott Diabetes Care Ltd ., Range Road, Witney, Oxon, OX29 0YL, UK .
Font License
©2013 Abbott
Licensed under the Apache License, Version 2 .0 (the “License”); you may
not use this file except in compliance with the License . You may obtain a
copy of the License at: http://www .apache .org/licenses/LICENSE-2 .0
Unless required by applicable law or agreed to in writing, software
distributed under the License is distributed on an “AS IS” BASIS,
WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either
express or implied . See the License for the specific language
governing permissions and limitations under the License .
May or may not be present or may vary per RA requirements .
119

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