MyStar Extra User manual

SAP-Nummer 521873
Sprachvariante 103
Erstellversion 4
Packmittel erstellt am 24.09.2013 / Keim
Packmittel geändert am 09.10.2013 / Perleth
Abmessungen Format (B x H) 101,6 x 139,7 mm
Farbe Cyan Magenta
Yellow Black
BLOOD GLUCOSE MONITORING SYSTEM
OWNER’S GUIDE

b
CAUTION: Please read all the instructions provided in this
Owner’s Guide and practice the testing procedures before using
the MyStar Extra® Blood Glucose Monitoring System. Self blood
glucose monitoring should be done under the guidance of a
healthcare professional.
Key Features of MyStar Extra®:
No Coding Required: The MyStar Extra® doesn’t require you
to enter a calibration code. Insert a BGStar® Test Strip and you
are ready to test.
Pre/Post-Meal Tagging: After you test, your result is tagged
with the mealtime. You can organize your data and see how
your test results change before meals, after meals, and when
fasting.
Estimate A1c: Use the estimated A1c (~A1c) tool to facilitate
a meaningful dialogue between patients and the healthcare
professional in between laboratory haemoglobin A1C tests.

1
©2013 Sanofi.
Meter Firmware ©2013 AgaMatrix, Inc. All rights reserved. All trademarks and/or copyrights are
the property of their respective owners. For patent information, see
www.agamatrix.com/patents.
Date of revision: September 2013
<MAT>521873
Toll-Free, 24-Hour Customer Service: 08000 35 25 25
In case of emergency, contact your healthcare professional or
emergency medical response.
Blood Glucose Monitoring System
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Distributed by:
Sanofi UK,
One Onslow Street,
Guildford, Surrey, GU1 4YS
Manufacturer:
AgaMatrix, Inc.
7C Raymond Avenue
Salem, NH 03079, USA

2
Contents
CHAPTER PAGE
Important Information About Your MyStar
Extra® Blood Glucose Monitoring System
Important Safety Instructions
Getting Started
About the MyStar Extra® Blood Glucose
Monitoring System
Important Disinfection Procedures
Important Health-Related Information
MyStar Extra® Meter Basics
Setting the Time and Date
Performing a Control Solution Test
How to Test Your Blood Glucose Level
Data Management Features
1 24
2 26
3 27
4 28
5 18
6 22
7 24
8 26
9 28
10 36
11 50
Logbook
11.1 51
Averages
11.2 55
Estimated A1c (~A1c)11. 3 58

3
CHAPTER PAGE
Batteries
Display Messages
Error Messages and Troubleshooting
Caring for Your MyStar Extra® Meter and
Lancing Device
MyStar Extra® Meter Specications
Symbols
12 71
13 74
14 78
15 87
16 88
17 90

4
Important Information About Your MyStar
Extra® Blood Glucose Monitoring System
CHAPTER
1
The MyStar Extra® System should be used:
[1] As indicated for single-patient use for self testing (over the counter
[OTC]) by persons with diabetes, as an aid to monitor the eectiveness
of diabetes control.
[2] For measuring blood glucose levels from fresh capillary whole
blood samples taken from the ngertip.
[3] For in vitro (i.e. outside of the body) diagnostic use only.
[4] With BGStar®Test Strips and Control Solution only. Do not use
other brands of test strips and control solution with this meter. This
may produce inaccurate results. BGStar®Test Strips are designed for
use with the Sano family of meters.
Do not use the MyStar Extra® System for:
[1] The diagnosis of diabetes.
[2] Testing the glucose levels of neonates (children younger than
4 weeks of age).
[3] Testing the glucose levels of pregnant women.
[4] Testing glucose levels of arterial or venous blood.
[5] Testing glucose from sites other than the ngertip.
Important Information About Your MyStar Extra® Blood Glucose Monitoring System

5
Important Information About Your MyStar Extra® Blood Glucose Monitoring System
Test site:
The MyStar Extra® System requires only a small droplet of blood
(0.5 microliters), about the size of a pinhead, to perform a glucose
test. Test using blood from the tip of any nger.
CAUTION: To ensure accurate results, wash your hands with warm,
soapy water and dry before and after every test. Unwashed hands
may lead to inaccurate results. Make sure there is no grease, oil, or
lotion on the ngertip. Use lancets only once. Do not use any lancet
or lancing device that has been used by another person.
The MyStar Extra® Blood Glucose Meter has small parts, store meter
away from children.

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Important Safety Instructions
The meter and lancing device are for single-patient use. Do not
share them with anyone, including other family members! Do not
use on multiple patients!
All parts of the kit are considered biohazardous and can potentially
transmit infectious diseases, even after you have performed
disinfection.
For important instructions for disinfecting your meter and lancing
device, please read Chapter 5.
CHAPTER
2
Important Safety Instructions

7
Getting Started
Getting Started
Your MyStar Extra® Blood Glucose Monitoring System MyStar
Extra® System) Kit contains:
• MyStar Extra® Blood Glucose Meter (Referred to as “MyStar Extra®
Meter” or “the meter”)
• Two pre-installed CR2032, 3 volt lithium batteries
• One Lancing Device with Cap
• Three bags of 10 33 gauge Lancets
• One Vial of 25 count BGStar® Blood Glucose Test Strips
• BGStar® Control Solution (control solution)
• MyStar Extra® Owner’s Guide
• One Set of Flashcards
• One Warranty Card
• One MyStar Extra® Compact Carrying Case
Dispose of packing material properly after unpacking your MyStar
Extra® System Kit.
Store the MyStar Extra® Blood Glucose Meter in the Carrying Case
when not in use.
IMPORTANT: To ensure accurate use of meter, check the time, date,
and units of measure.
For step-by-step instructions on changing the time and date settings,
please refer to Chapter 8.
CHAPTER
3

8About the MyStar Extra® Blood Glucose Monitoring System
About the MyStar Extra® Blood
Glucose Monitoring System
CHAPTER
4
The MyStar Extra® Blood Glucose Monitoring System is made up of
the MyStar Extra® Blood Glucose Meter, BGStar® Test Strips, BGStar®
Control Solution, and a lancing system.
About the MyStar Extra® Meter
(1) Display: Glucose test results,
icons, calculations, and error messages
appear here.
(2) CHECK ( ) Button: Use the
CHECK button to activate and
deactivate the meter, access the
settings menu, conrm a selection,
navigate between modes and activate
the backlight.
(3) UP ( ) Arrow Button:
Use the UP arrow button to scroll
backward through options.
(4) DOWN ( ) Arrow Button:
Use the DOWN arrow button to scroll
forward through options.
(5) MEALTIME ( ) Button: Use the MEALTIME button to select
mealtime tags for readings.

9
About the MyStar Extra® Blood Glucose Monitoring System
(6) Test Strip Port: Insert the BGStar® Test Strip, with the contact
bars facing up, into the test strip port.
(7) Mini-USB Port: Use for communication with Sano approved
software and devices (where available). Do not connect other cables
or devices into this port.
About the BGStar® Test Strip
(1) Front of the Test Strip: The front of the
test strip is black in colour. Ensure that the front
(black-coloured) side of the test strip is facing
towards you when inserting a test strip into
the meter test strip port.
(2) Back of the Test Strip: The back of the test
strip is white in colour. Ensure that the back (white-coloured) side of
the test strip is facing away from you when inserting a test strip into
the meter test strip port.
(3) Contact Bars: This end is inserted, front of the test strip facing
towards you, into the meter test strip port.
(4) Sample Area: Blood or control solution should be applied to
the tip of the test strip here.
(5) Visual Fill Window: This window will turn red when enough
blood has been applied or blue when enough control solution has
been applied.
IMPORTANT: Use test strips only once. Use only BGStar® Test
Strips with your MyStar Extra® Meter.

10 About the MyStar Extra® Blood Glucose Monitoring System
Important test strip information:
[1] Store the BGStar® Test Strip vial in a dry place at 8°C to 30°C .
[2] Use BGStar® Test Strips only within the system operating
temperature range of 10°C to 40°C.
[3] Keep away from direct sunlight and heat.
[4] Store your test strips in their original vial only. Never store them
in another vial, in any other container, or outside the vial.
[5] Handle the test strip with clean, dry hands.
[6] After removing a test strip from the vial, immediately close the
vial cap tightly.
[7] Do not use test strips beyond the expiration date or 180 days
after rst opening the vial. This may result in inaccurate readings.
Write the discard date (180 days from the rst opening) in the space
provided on the test strip vial.
[8] Do not bend, cut, or alter test strips.
[9] Apply only fresh capillary whole blood or control solution to the
sample area of the test strip.

11
About the MyStar Extra® Blood Glucose Monitoring System
About the BGStar® Control Solution
The MyStar Extra® System has 2 dierent levels of control solution
available – Normal and High. The Normal Control Solution is provided
with the MyStar Extra® System Kit. If you would like to use High
Control Solution, please contact Customer Service at 08000 35 25 25
Control solution should be used only for 90 days after rst opening
the bottle or until the expiration date printed on the label, whichever
comes rst.
IMPORTANT: Count forward 90 days from the date you open a
new bottle of control solution. This is your discard date. Write the
discard date on the control solution bottle.
The control solution is used to:
[1] Ensure that your meter and test strips work properly together.
[2] Practice testing without having to use your own blood.
Important BGStar® Control Solution information:
[1] Use only BGStar® Control Solution with your MyStar Extra® Meter.
[2] Always shake the control solution bottle before use.
[3] Always discard the rst drop of control solution and wipe the
bottle tip clean using a clean tissue or paper towel.

12
[4] Replace the cap on the control solution bottle immediately after
use.
[5] Do not add water or any other liquid to control solution.
[6] Control solution tests should be performed within the system
operating temperature range of 10°C to 40°C.
About the Lancing System
Note: Lancing devices and lancets are only intended for a single user
and should not be shared between users.
About the MyStar Extra® Meter Display and Icons
Backlight: The backlight is
illuminated whenever the meter
is activated. It will deactivate
after thirty seconds of inactivity.
The backlight will be reactivated
by pressing any button before
advancing screens.
(1) Date and Time: The date and time appear on each
reading in your meter.
(2) Units of Measurement: Results will be
displayed in mmol/L.
About the MyStar Extra® Blood Glucose Monitoring System

13
About the MyStar Extra® Blood Glucose Monitoring System
(3) Control Solution Icon: Appears to the left of the
date when viewing a control solution test result.
(4) Apply Sample to Test Strip Message: After
inserting a new test strip, a ashing droplet icon will
appear on the meter display as well as the current
date and time. This means that the meter is ready
and you can now apply a sample to the test strip.
A sample may be either control solution or blood.
(5) Calculating Animation: An animated sequence of “1, 2, 3” will
appear on the meter display after a sample has been applied to the
test strip. This means the meter is calculating the test result.

14 About the MyStar Extra® Blood Glucose Monitoring System
(6) Calculating ~A1c Animation: An animated sequence of
appearing and disappearing bars will appear on the meter display
while an ~A1c result is being calculated.
(7) Mealtime Tags: The mealtime tags appear after a test is complete
and help categorize your results.
There are four icons for Mealtime tags:
No Tag
Fasting
Pre Meal
Post Meal
Tag Icons:

15
About the MyStar Extra® Blood Glucose Monitoring System
(8) Menu Icons: These icons represent the
four dierent modes:
(9) Date and Time Icons: The date icon ( )
and the time icon ( ) are displayed next to
the date and time when you are in the settings
screen.
(10) Number of Days used for Average Calculations: The date
icon ( ) is displayed on the averages screen to indicate the number
of days used in the average calculation.
(11) Number of Days remaining until your next prole is needed:
The date icon ( ) is displayed on the ~A1c results screen indicating
the number of days remaining until your next prole is needed.
1. Logbook
2. Averages
3. Estimated A1c
4. Settings

16 About the MyStar Extra® Blood Glucose Monitoring System
(12) Number of Readings used in Calculations: The number of
readings used in the average calculation is indicated next to the
number icon ( ).
(13) Trending Arrows: Trending arrows
may be seen in the Logbook as well as
the ~A1c results screen. The trend arrows
in the logbook illustrates the direction
of your average fasting glucose reading
from the past 3 days as compared to the
median fasting value over the 7 days
before. The trend arrows in the ~A1c results screen indicate the trend
of your A1c result compared to two weeks ago.
(14) Temperature Icon: Appears when the meter is outside
its operating temperature range of 10°C to 40°C.
Number of readings
used in calculation
Number of days
used in calculation
Averages Mode Icon
1. Trending up
2. Trending down
3. Steady

17
About the MyStar Extra® Blood Glucose Monitoring System
(15) Low Battery Icon: Appears when battery #2 (see
Chapter 12) in your meter is running low. For complete
instructions on identifying and changing your meter
batteries, refer to Chapter 12.
(16) Dead Battery Icon: Appears when battery #2 in your
meter is dead. For complete instructions on identifying
and changing your meter batteries, refer to Chapter 12.

18
Important Disinfection Procedures
When using your meter, avoid getting dirt, dust, blood, control
solution, water, or any other liquid inside the test strip port, battery
compartment and mini-USB port. You should wash your hands
thoroughly after handling the meter, lancet, lancing device, and
test strips. Your meter and lancing device should be disinfected
periodically. Cleaning and disinfecting will kill the bacteria and
viruses that you cannot see.
Cleaning and disinfecting your meter and lancing device
CAUTION: Never immerse the meter or the body of the lancing device
in water or any other liquid solution. Be careful when cleaning and
disinfecting your meter. Avoid getting liquid inside the test strip
port and mini-USB port.
CHAPTER
5
Important Disinfection Procedures