Abbott FreeStyle Libre User manual

Quick Start Guide
Reader and Sensor Demo Kit

Contents
Intended Use ............................................ 1
System Overview........................................ 1
Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Checking Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Reviewing History....................................... 8
Disposal ................................................. 9
Demo System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Demo Sensor Specications .............................10
Demo Reader Specications .............................11
Labelling Symbols......................................13

Intended Use
The FreeStyle Libre Demo Kits are intended for the purpose of
demonstration of the FreeStyle Libre Flash Glucose Monitoring System
only.
System Overview
The FreeStyle Libre Demo Kit has two main parts: a handheld Demo
Reader and a Demo Sensor contained in a clear display case. Use the
Demo Reader and Demo Sensor in the kit to get simulated readings and
demonstrate key features of the FreeStyle Libre Flash Glucose Monitoring
System. The glucose readings displayed on the FreeStyle Libre Reader
are pre-loaded non-patient specic data and are only provided as a
means to demonstrate the function of the System. The Reader also has a
non-functional test strip port that is intended to help simulate the blood
testing process. The FreeStyle Libre Demo Kit is not intended for diabetes
management. Do not use with commercial FreeStyle Libre system.
1

When opening your FreeStyle Libre Demo Kit, check that the contents are
undamaged and that you have all parts listed. If any parts are missing or
damaged, contact Customer Service.
The FreeStyle Libre Demo Kit includes:
• FreeStyle Libre Demo Reader
• FreeStyle Libre Demo Sensor in a clear display case
• Micro USB Cable
• Power Adapter(s)
• Demo Kit Insert
2

Reader
Sensor
FreeStyle Libre Sensor
Placed in a clear display case.
USB Port
Used to charge the Reader
and connect it to a computer.
Test Strip Port
Non-functional test strip port
for demonstrations only.
Touchscreen
Home Button
Turns the Reader on/o
and returns to the Home
screen from any
other screen.
3

The Reader Home Screen provides access to information about glucose
and the System. Press the Home Button to get to the Home Screen.
Home Screen
Ends in 14 days
22:23
Check
Glucose
Review
History
Time
Current time set on
the Reader.
Sensor Status
Information about the
current Sensor.
Battery Level
Battery charge remaining.
Settings
Touch to change the
Reader’s settings.
Review History
Touch to review
information about past
glucose readings.
Check Glucose
Touch to check the
Sensor glucose.
Reminder
Touch to set or change
reminders.
4

The Sensor Glucose Readings screen appears after the Reader scans the
Sensor. The Reading includes Current Glucose, a Glucose Trend Arrow
indicating which way glucose is going, and a graph of current and stored
glucose readings.
Sensor Glucose Readings
21
15
9
3
14:00 18:00 22:00
4.0
mmol
L
Glucose Going
Low
Rapid-Acting
Insulin Note
Message
Touch for more
information.
Add Notes
Touch to add notes to
the glucose reading.
Food Note
Current Glucose
Glucose from
latest scan.
Glucose Trend Arrow
Direction glucose is going.
Glucose Graph
Graph of current and
stored glucose
readings.
72 mg/dL
(350)
(250)
(150)
(50)
5

Checking Glucose
Use the Reader to wirelessly scan the Demo Sensor and get a sample
reading. The Demo Reader will cycle through 10 dierent pre-loaded
readings screens in sequential order upon each successful scan. Powering-
o the Reader will not aect the order of display. The demo Reader will
not read a Sensor that has been applied to a body.
Step Action
1Turn the Reader on by pressing
the Home Button or touch
Check Glucose from the Home
Screen.
2Hold the Reader within 4 cm (1.5 inches) of the Sensor to scan it.
If sounds are turned on, the Reader beeps when the Sensor has
been successfully scanned.
22:23
Check
Glucose
Review
History
Ends in 14 days
OR
6

Step Action
3The Reader displays the current glucose reading
along with a glucose graph and an arrow
indicating the direction glucose is going.
72 mg/dL
21
15
9
3
mmol
L
Glucose Going
Low
14:00 18:00 22:00
4.0
7

Reviewing History
The Reader has several ways to review past glucose readings, notes, and
other information. The demo Reader has been pre-loaded with 90 days of
historic data. This data will be time stamped at each power up so that the
current time is used for the most recent value.
Step Action
1Press the Home Button to turn on
the Reader. Press the Home Button
again to go to the Home Screen.
2Touch the Review History icon.
Check Glucose
Scan Sensor to check
glucose.
22:23
Check
Glucose
Review
History
Ends in 14 days
8

Step Action
3Use the arrows to view the available options.
Disposal
This product must not be disposed of via standard waste
collection. Separate collection for electrical and electronic
equipment waste per Directive 2012/19/EC in the European
Union is required.
Contact Customer Service for further information on the appropriate
disposal of the FreeStyle Libre Demo Kit.
Logbook
Daily Graph
Average Glucose
Review History
1 / 2
Daily Patterns
Time In Target
Low-Glucose Events
Sensor Usage
9

Demo System Specifications
Demo Sensor Specifications
Sensor size 5 mm height and 35 mm diameter
Sensor power source One silver oxide battery
Operating and storage
temperature 10 °C to 45 °C
Operating and storage
relative humidity 10-90%, non-condensing
Operating and storage
altitude
-381 metres (-1,250 ft) to
3,048 metres (10,000 ft)
10

Demo Reader Specifications
Reader size 95 mm x 60 mm x 16 mm
Reader power source One lithium-ion rechargeable battery
Reader operating
temperature 10 °C to 45 °C
Reader storage
temperature -20 °C to 60 °C
Operating and storage
relative humidity 10-90%, non-condensing
Reader moisture
protection Keep dry
11

Operating and storage
altitude
-381 metres (-1,250 ft) to
3,048 metres (10,000 ft)
Reader display timeout 60 seconds
Radio Frequency 13.56 MHz RFID; ASK Modulation;
124 dBuV/m
Data port Micro USB
Power Adapter Abbott Diabetes Care PRT25612
Operating temperature: 10 °C to 40 °C
USB Cable Abbott Diabetes Care PRT21373
Length: 94 cm (37 inches)
12

Labelling Symbols
Manufacturer Environmentally friendly use
period of 10 years
CE Mark Serial number
Keep dry Non-ionising radiation
This product must not be disposed of via standard 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.
13

Hereby, Abbott Diabetes Care Ltd., declares that the radio equipment type
FreeStyle Libre Demo Kit is in compliance with Directive 2014/53/EU. The
full text of the EU declaration of conformity is available at the following
internet address: www.diabetescare.abbott/doc
Refer to the FreeStyle Libre Flash Glucose Monitoring System User
Manual for the commercial product for full instructions and contact
your sales representative if you have questions.
Font Licence
©2013 Abbott
Licensed under the Apache Licence, Version 2.0 (the “Licence”); you may not
use this le except in compliance with the Licence. You may obtain a copy of
the Licence at: http://www.apache.org/licenses/LICENSE-2.0
Unless required by applicable law or agreed to in writing, software distributed
under the Licence is distributed on an“AS IS”BASIS, WITHOUT WARRANTIES OR
CONDITIONS OF ANY KIND, either express or implied. See the Licence for the
specic language governing permissions and limitations under the Licence.
14

©2017 Abbott ART38932-005 Rev-A 08/17
Manufacturer:
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various
jurisdictions. Other trademarks are the property of their respective owners.
Patent: https://www.abbott.com/patents