Abbott FreeStyle LibrePro User manual

Operator’s Manual
FLASH GLUCOSE MONITORING SYSTEM
CAUTION: Federal law restricts this device
to sale by or on the order of a physician.

Contents
Reader Symbols ......................................... 1
Important Safety Information........................... 2
Indications for Use........................................ 2
Contraindications ........................................ 3
Getting to Know the System............................. 7
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Sensor Kit ................................................ 9
FreeStyle Libre Pro Software .............................11
Setting up the Reader for the First Time................12
Using the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Applying the Sensor .....................................15
Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Patient Wear.............................................21
Getting Sensor Data .....................................22
Removing the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Reader Options.........................................27
Maintenance and Disposal .............................30
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Problems at the Sensor Application Site ..................32
Problems Starting the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Problems Getting Sensor Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Reader Error Messages...................................36
Perform a Reader Test....................................37
Customer Service........................................37
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Labeling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Electromagnetic Compatibility.........................64
Limited Warranty.......................................74

Reader Symbols
Symbol What It Means
View previous/next screen
Options
Low battery
Battery charging
Conrm Sensor reminder
Communication strength
Data to report
1

Important Safety Information
Indications for Use
The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional
continuous glucose monitoring (CGM) device indicated for detecting trends
and tracking patterns in persons (age 18 and older) with diabetes. The System
is intended for use by health care professionals and requires a prescription.
Readings from the FreeStyle Libre Pro Sensor are only made available to
patients through consultation with a health care professional. The System
does not require user calibration with blood glucose values.
The FreeStyle Libre Pro System aids in the detection of glucose level
excursions above or below the desired range, facilitating therapy adjustments.
Interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System
readings should be based on the trends and patterns analyzed through time
using the reports available.
IMPORTANT: The device may inaccurately indicate hypoglycemia.
The results of the clinical study conducted for this device
showed that 40% of the time when the device indicated that
user sensor glucose values were at or below 60 mg/dL, user
glucose values were actually in the range of 81-160 mg/dL.
Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose
Monitoring System readings should only be based on the trends
and patterns analyzed through time using the reports available
per the intended use.
2

Contraindications
The FreeStyle Libre Pro Flash Glucose Monitoring System
must be removed prior to Magnetic Resonance Imaging (MRI),
Computed Tomography (CT) scan, or high-frequency electrical
heat (diathermy) treatment. The eect of MRI, CT scans, or
diathermy on the performance of the System has not been
evaluated. The exposure may damage the Sensor and may
impact proper function of the device to detect trends and track
patterns in the user’s glucose values during the wear period.
WARNING: The FreeStyle Libre Pro Flash Glucose Monitoring
System contains small parts that may be dangerous if
swallowed.
CAUTION:
• Performance of the System when used with other implanted
medical devices, such as pacemakers, has not been evaluated.
• Some individuals may be sensitive to the adhesive that
keeps the Sensor attached to the skin. If your patient notices
signicant skin irritation around or under their Sensor, they
should remove the Sensor and stop using the FreeStyle Libre
Pro System. Follow your facility’s procedures for handling
skin reactions.
3

Warnings/Limitations
• Review all product information before use.
• Physiologic dierences between the interstitial uid and capillary blood
may result in dierences in glucose readings. Dierences in glucose
readings between interstitial uid 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.
• Do not reuse Sensors. The Sensor and Sensor Applicator are designed
for single use. Reuse may result in no glucose readings and infection.
Not suitable for re-sterilization. Further exposure to irradiation may
cause inaccurate results.
• Interfering Substances: Taking ascorbic acid (vitamin C) while wearing
the Sensor may falsely raise Sensor glucose readings. Taking salicylic
acid (used in some pain relievers such as aspirin and some skin care
products) may slightly lower Sensor glucose readings. The level of
inaccuracy depends on the amount of the interfering substance active
in the body. Test results did not indicate interference for methyldopa
(used in some drugs to treat high blood pressure) or tolbutamide
(infrequently used in some drugs to treat diabetes in the US) at
maximum circulating levels. However, concentrations of potential
interferents in interstitial uid are unknown compared to circulating
blood.
4

• Take standard precautions for transmission of blood borne pathogens
to avoid contamination.
• The Reader should be cleaned between patients.
• If a Sensor breaks inside a patient, remove with tweezers, treat any
medical complications and call Customer Service.
• Use of the System is not recommended in the critically ill population
since performance is unknown due to dierent conditions and
medications.
• Sensor placement is not approved for sites other than the back of the
arm. If placed in other areas, the Sensor may not function properly.
• If the Sensor Kit package or contents or the Reader appear to be
damaged, do not use as there may be a risk of electric shock, no results,
and/or infection.
• Store the Sensor Kit between 39°F-77°F. While you don’t need to keep
the Sensor Kit in a refrigerator, you can as long as the refrigerator is
between 39°F-77°F.
• Store the Sensor Kit between 10-90% non-condensing humidity.
• The System does not provide real-time results. Patients need to rely on
blood glucose readings for monitoring glucose during System use.
• Clean hands prior to Sensor handling/insertion to help prevent
infection.
• Clean the application site and ensure that it is dry prior to Sensor
insertion. This helps the Sensor stay attached to the body.
5

• Change the application site for the next Sensor application to prevent
discomfort or skin irritation.
• Select an appropriate Sensor site to help the Sensor stay attached to the
body and prevent discomfort or skin irritation. Avoid areas with scars,
moles, stretch marks, or lumps. Select an area of skin that generally stays
at during normal daily activities (no bending or folding). Choose a site
that is at least 1 inch away from an insulin injection site.
• The Sensor should not be worn more than 14 days. Readings are not
obtained after 14 days.
• The Sensor should be removed prior to exposing it to an X-ray machine.
The eect of X-rays on the performance of the system has not been
evaluated. The exposure may damage the Sensor and may impact
proper function of the device to detect trends and track patterns in the
user’s glucose values during the wear period.
• The FreeStyle Libre Pro Flash Glucose Monitoring System has not been
evaluated for use in pregnant women, persons on dialysis, or people less
than 18 years of age.
6

Getting to Know the System
The FreeStyle Libre Pro Flash Glucose Monitoring System has three main
parts: a handheld Reader, a disposable Sensor, and FreeStyle Libre Pro
software. A single FreeStyle Libre Pro Reader can be used to gather data
from FreeStyle Libre Pro Sensors on multiple patients.
When opening the Reader Kit and Sensor Kit, check that the contents
are undamaged and that you have all parts listed. If any parts are missing
or damaged, contact Customer Service.
IMPORTANT: Safety information about the
System is in this Operator’s Manual. Read all of
the information in the Operator’s Manual before
using the System.
7

Reader Kit
The Reader Kit includes:
• FreeStyle Libre
Pro Reader
• USB Cable
• Power Adapter
• Operator’s Manual
• Quick Start Guide
The Reader is used to start the Sensor on a patient and gather their
glucose readings. Multiple patients can have their Sensor started by the
same Reader.
USB Port
Used to charge the
Reader and connect
it to a computer.
Touchscreen
Home Button
Turns the Reader on/o
and takes you to the
Home Screen from any
other screen.
8

Sensor Kit
The Sensor Kit includes:
• Sensor Pack
• Sensor Applicator
• Alcohol wipe
• Product insert
Sensor Pack
Used with the Sensor Applicator to
prepare the Sensor for use.
Sensor Applicator
Applies the Sensor to the patient’s body.
The Sensor measures and stores glucose readings when worn on the
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, prepare and apply the Sensor on the back
of the patient’s upper arm. The Sensor has a small,
exible tip that is inserted just under the skin. The
Sensor can be worn for up to 14 days.
Sensor
Measures glucose while on body
(only visible after applied).
9

The Reader Home Screen provides access to starting a new Sensor, getting
Sensor data, and information about the System.
Home Screen
10:23pm
Start New
Sensor
Get Sensor
Data
Time
Current time set on
the Reader.
Battery Level
Battery charge remaining.
Options
Touch to view or change
the Reader’s options.
Get Sensor Data
Touch to download all
glucose readings from the
Sensor into the Reader.
Start New Sensor
Touch to start a new
Sensor.
10

FreeStyle Libre Pro Software
FreeStyle Libre Pro software can be used to create reports based on
glucose readings from the most recently downloaded Sensor. The
software is compatible with most Windows and Mac operating systems.
Go to www.FreeStyleLibrePro.com and follow onscreen instructions to
download and install the software.
INTENDED USE
The FreeStyle Libre Pro software is intended for use by health
care professionals to aid in the review, analysis and evaluation of
a patient’s glucose readings uploaded from the FreeStyle Libre
Pro Flash Glucose Monitoring System in support of an eective
diabetes health management program.
11

Setting up the Reader for the First Time
Before using the System for the rst time, the Reader must be set up.
Step Action
1Press the Home Button to turn on the Reader.
2If prompted, use the touchscreen to select your
preferred language for the Reader. Touch OK to
continue.
Note: Use the pad of your nger. Do NOT use
your ngernail or any other object on the screen.
3Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
11
back next
Current Date
June
2017
12

Step Action
4Set the Current Time. Touch next to continue.
5
mg
dL
80 to 140
back next
Target Glucose
Range
?Set the Target Glucose Range. Touch next to
continue.
Note: The Target Glucose Range is displayed on
the Daily Graph on the Reader once Sensor data
has been downloaded. While the glucose data
are gathered in the System range of 40-500 mg/dL,
the Daily Graph display range is 0-350 mg/dL for
ease of review on screen.
6
doneback
While using the Reader, press
the Home button to return to
the Home screen.
The Reader now indicates how to return to the
Home Screen from any other screen. Touch done
to go to the Home Screen.
Note: Charge the Reader if the battery level is low. Only use the USB
cable and power adapter included with the System.
12am 00
back next
Current Time
CAUTION: It is very important to set the time
and date correctly for correct interpretation
of Sensor data.
13

Using the Sensor
After you assemble and apply the Sensor to your patient’s body, start
the Sensor with the Reader and conrm it is working. The Sensor stores
glucose readings every 15 minutes for up to 14 days. The rst reading is
stored 1 hour after the Sensor is successfully started.
CAUTION:
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 before using
the Sensor Pack and Sensor Applicator. Sensor
Packs and Sensor Applicators with the same
Sensor code should be used together or
Sensor glucose readings may be incorrect.
CODE
FreeStyle Libre
Sensor Pack
A
b
b
o
t
t
D
i
a
b
e
t
e
s
C
a
r
e
L
t
d
.
R
a
n
g
e
R
o
a
d
,
W
i
t
n
e
y
,
O
x
o
n
,
O
X
2
9
0
Y
L
,
U
K
D
O
C
3
0
3
9
1
R
e
v
.
B
0
9
/
1
3
XXXXXXXXX
XXX
YYYY-MM-DD
14

Applying the Sensor
Step Action
1Apply Sensors only on the back of your patient’s
upper arm. Avoid areas with scars, moles, stretch
marks, or lumps.
Select an area of skin that generally stays at
during normal daily activities (no bending or
folding). Choose a site that is at least 1 inch
(2.5 cm) away from an insulin injection site.
To prevent discomfort or skin irritation, you
should select a dierent site other than the
one most recently used.
2Clean application site with an alcohol wipe and
allow site to dry before proceeding. This helps
the Sensor stay attached to the body.
Note:The area MUST be clean and dry, or the
Sensor may not stick to the site.
15

Step Action
3Open the Sensor Pack by peeling the lid o
completely. Unscrew cap from the Sensor
Applicator and set the cap aside.
4Line up the dark mark on the Sensor Applicator
with the dark mark on the Sensor Pack. Press
rmly down on the Sensor Applicator until it
comes to a stop.
5Lift the Sensor Applicator out of the Sensor Pack.
Lid
Cap
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.
16

Step Action
6The Sensor Applicator is prepared and ready to
apply the Sensor.
7Place the Sensor Applicator over the prepared
site and push down rmly to apply the Sensor to
the body.
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 push down on the Sensor
Applicator until placed over prepared site to
prevent unintended results or injury.
17