AgaMatrix iBGStar User manual

Blood Glucose Monitoring System
For use with the iBGStar Diabetes Manager
Application on iPhone®or iPod touch®
OWNER’S GUIDE
File name: 513109 Artwork, Guide,
Owners, mgdl, iBGStar, US
Revision: -
Date: 2.15.12
Operator: TM
Site/Supplier: Frankfurt Devices/
AgaMatrix
Product Desc.: Owner’s Guide,
iBGStar Meter
Artwork created in: InDesign CS5,
Mac format
Minimum point size of text: 5 pt
Barcode: -
Colors Used: CMYK

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Toll-Free, 24-Hour Customer Service: 1-800-633-1610
In case of emergency, contact your healthcare professional or
emergency medical response.
Key Features
iBGStar™Diabetes Manager Application -
an iPhone and iPod touch application (app)
designed for the iBGStar™Meter: The iBGStar
Meter can easily download test results to the
iBGStar Diabetes Manager Application via the
dock connector on the iPhone or iPod touch.
The app can be used to conveniently store and
manage your diabetes information, review trends,
or share with your healthcare team. It can be
downloaded from the App StoreSM.
No Coding Required: The iBGStar Meter doesn’t
require you to code the meter. Insert a BGStar®
Test Strip and you are ready to test.
Blood Glucose Monitoring System
By using the iBGStar Blood Glucose Monitoring System (Meter) with the
iBGStar Diabetes Manager Application (the app): You agree that the use
of this software together with an iPod, iPhone or iPad (“Apple Product”) shall
only be as a personal organization or supplemental data display tool and not
as a source of medical advice. You agree that this software will never be used
to replace the advice of a doctor, or your own common sense and independent
judgment, and that you will not at any time rely on any information presented
on your Apple Product as the basis for health care, medical or other decisions
that may result in injury or other ill effects. You agree to take sole responsibility
for your health care decisions, including contacting a physician or other
health care professional regarding all medical conditions, tests, diagnoses and
treatment options and agree that Apple shall have no liability for any action
you or anyone using the software may take, regardless of the information
received, displayed, calculated or transmitted by your Apple Product.
Apple assumes no risk for your use of the software and makes no warranties
whatsoever, express or implied, regarding the accuracy, completeness or
usefulness of any information presented on your Apple Product as a result of
using the software.
Manufacturer: AgaMatrix, Inc. 7C Raymond Avenue, Salem, NH 03079 USA
Distributed by sanofi-aventis U.S. LLC, Bridgewater, NJ 08807
©2013 sanofi-aventis U.S. LLC
Meter Firmware ©2013 AgaMatrix, Inc. All rights reserved. All trademarks and/or copyrights
are the property of their respective owners. US and International patents pending. iPhone,
iPod, iPod touch, and iTunes are trademarks of Apple Inc., registered in the U.S. and other
countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes
Store is for personal lawful use only. Don’t steal music.
“Made for iPod” and “Made for iPhone” mean that an electronic accessory has been
designed to connect specifically to iPod or iPhone, respectively, and has been certified
by the developer to meet Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory standards. Please
note that the use of this accessory with iPod or iPhone may affect wireless performance.

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Contents
Getting Started
About the iBGStar Blood Glucose
Monitoring System
How to Install and Update the iBGStar Diabetes
Manager Application
Important Health-related Information
Important Information About Your iBGStar
Blood Glucose Monitoring System
Important Disinfection Procedures
Important Information About Performing
Control Solution Tests
How to Perform a Control Solution Test
Important Information About Testing Your
Blood Glucose Level
How to Test Your Blood Glucose Level
Obtaining a Blood Sample From Alternate Sites
(Palm or Forearm)
Syncing for the First Time
Syncing
Viewing Past Test Results on the
iBGStar Meter
Display Messages
Error Messages and Troubleshooting
iBGStar Meter Battery and Charging
Caring for Your iBGStar Meter and
Lancing Device
iBGStar Meter Specifications
Warranty
Electromagnetic Compatibility (EMC)
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TITLE TITLE
Contents Contents

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The System Kit contains:
Owner’s Guide, Reference Guide, Registration & warranty Card
and Carrying Case (not shown)
Getting Started
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CHAPTER
Unpack your System Kit. Dispose of the packing material properly.
Charge the iBGStar Meter’s battery by following instructions in
Chapter 17.
IMPORTANT: To ensure accurate use of the iBGStar Meter (the meter)
or iBGStar Diabetes Manager Application (the app), the time and
date must be correctly set on your iPhone or iPod touch. For
instructions on how to set the time and date on your iPhone or iPod
touch, refer to the support materials for each device. The time and
date from your iPhone or iPod touch will be used to set the time and
date on your meter whenever it syncs. For step-by-step instructions
on setting time and date for the first time, refer to Chapter 13.
System requirements
3iPhone or iPod touch with at least 30 MB of available space.
3Check www.ibgstar.comwww.ibgstar.com to see which iPhone
and iPod touch, and which versions of the Apple Operating
Systems (iOS versions), are supported.
3Made for iPhone 3G, 3GS, 4, and 4S, iPod touch (2nd, 3rd, and
4th generation).
3For use with iPhone 5 or iPod touch (5th generation), an Apple
Lightning to 30-pin Adapter (not included in package) is required.
3iOS 4, 5, or 6
3The iBGStar Diabetes Manager App installed on that iPhone or
iPod touch.
The iPhone and iPod touch are sold separately. The iBGStar Diabetes
Manager Application is not included with the iBGStar Blood Glucose
Monitoring System . It can be downloaded from the App Store on your
iPhone or iPod touch. To install the app, follow instructions in Chapter 3
Getting Started Getting Started
iBGStar Blood Glucose
Meter
Dock Connector Cover
Lancing Device with Cap
(Works with most generic lancets,
such as BD Ultra-Fine™ 33 Gauge Lancets)
Power Adapter
Sterile Lancets
Clear AST Lancing Device Cap
Micro-USB to USB Cable
1 Vial of 10 Test Strips
Control Solution
x10

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About the BGStar Blood Glucose Test Strip:
(1) Front of the Test Strip: The front of the test strip is black
in color. Ensure that the front (black-colored) side of the test
strip is facing towards you when inserting a test strip into the
meter’s test strip port.
(2) Back of the Test Strip: The back of the test strip is white
in color. Ensure that the back (white-colored) side of the test
strip is facing away from you when inserting a test strip into
the meter’s test strip port.
(3) Contact Bars: This end is inserted, front of the test strip
facing towards you, into the meter’s 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.
About the iBGStar Blood Glucose
Monitoring System
2
CHAPTER
About the iBGStar Meter (the meter)
(1) Dock Connector Cover: Covers the dock connector when
not in use.
(2) Dock Connector: This end inserts into the iPhone or iPod
touch’s 30-pin dock connector port. The dock connector port
is located below the home button of either device.
(3) Display Area: Glucose test results, symbols and messages
appear here.
(4) Meter Button: The right-side of the meter’s display is a
button. It is used to activate or deactivate the iBGStar and
view past test results.
(5) Micro-USB Port: Used to connect to the power adapter or
a PC (personal computer) via the micro-USB to USB cable.
(6) Test Strip Port: Insert the BGStar Blood Glucose Test Strip,
with the contact bars facing up, into the test strip port.
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About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System
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[9] Apply only fresh capillary blood or control solution to the
sample area of the BGStar Blood Glucose Test Strip.
About the Micro-USB to USB Cable and Power Adapter
(1) Micro-USB to USB Cable: Used to connect the meter to
the power adapter or a PC.
(2) Micro-USB Connector (Cable): This end inserts into the
meter’s micro-USB port.
(3) USB Connector (Cable): This end inserts into the power
adapter or a PC’s USB port.
(4) Power Adapter: Used to charge your meter. It will also
charge the iPhone or iPod touch, if the meter is connected
to the iPhone or iPod touch. Insert plug into a wall outlet
(100-240v, 50-60 Hz).
(5) Power Adapter’s USB Port: Used to connect to the
iBGStar meter via the micro-USB to USB cable.
IMPORTANT: Use BGStar Blood Glucose Test Strips only once.
Only use BGStar Test Strips with the BGStar or iBGStar Blood
Glucose Monitoring System(s).
Important test strip information:
[1] Store the BGStar Blood Glucose Test Strip vial in a cool, dry
place at 46°F to 86°F (8°C to 30°C).
[2] Use BGStar Blood Glucose Test Strips only within the
system operating temperature range of 50°F to 104°F (10°C
to 40°C).
[3] Keep away from direct sunlight and heat.
[4] Store your BGStar Blood Glucose Test Strips in their original
vial only. Never store them in another vial, any other container
or outside the vial.
[5] With clean, dry hands you may gently handle the BGStar
Blood Glucose Test Strip when removing it from the vial or
inserting it into the iBGStar.
[6] After removing a BGStar Blood Glucose Test Strip from the
vial, immediately close the vial cap tightly.
[7] Do not use BGStar Blood Glucose Test Strips beyond the
expiration date or 180 days after first opening the vial. This
may cause inaccurate results. Write the discard date (180 days
from the first opening) on the test strip vial.
[8] Do not bend, cut or alter BGStar Blood Glucose Test Strips.
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About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System

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About the iBGStar Meter Display
and Symbols
(1) Glucose Test Result.
(2) Units of Measurement (scrolls
across display): Results will be
displayed in mg/dL.
(3) Time (scrolls across display):
Syncing will configure the time format
to match your iPhone or iPod touch’s
settings. The format is in either 12 or
24 Hour.
(4) Date (scrolls across display):
Syncing will configure the date format
to match your iPhone or iPod touch’s
settings. The format is in either
MM/DD/YY or DD/MM/YY.
(5) Control Solution Symbol:
Appears to the right of control
solution test results.
(6) Apply Sample to Test Strip
Animation: During testing, an
animation of a sample being applied
to the test strip will appear on the
meter display. This means you may
apply a sample to the test strip. A
sample may either be control solution
or blood.
About the iBGStar Lancing System
Note: Lancing Devices and Lancets are only intended for a
single user and should not be shared between users.
(1) Cocking Handle: Cocks the device so it is ready to lance.
(2) Depth Adjustment Dial: Adjusts how deep the lancet will
lance the skin.
(3) Depth Indicator Window: Displays the depth setting of
the lancing device.
(4) Release Button: Fires the lancet.
(5) Lancet Holder Cup: Holds the lancet into place inside the
lancing device.
(6) Lancing Device Cap: Covers the lancet when in lancing
device.
(7) Alternative Site Testing Cap: Used for obtaining a blood
sample on the palm (at the base of the thumb) or forearm.
(8) Lancet: Lances the skin to produce a drop of blood.
(9) Lancet Cover: Covers the lancet for safety. Remove after
inserting into the lancet holder cup.
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About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System
Example Results:

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(11) Battery Status:
Shows the amount
of power in the
iBGStar’s battery.
(12) Charging Battery Symbol:
Appears to the left of the Battery
Status symbol when the meter’s
battery is being charged.
Example of 60% Battery Power Remaining =
(7) Sample Applied Symbol: During
testing, this symbol will appear when
you should remove the test strip from
the sample.
(8) Calculating Animation (“1,2,3”
countdown): During testing, an
animated sequence of bars and “1,2,3”
will appear on the meter display. This
is after a sample has been applied to
the test strip. This means the meter
is calculating the test result.
(9) iBGStar Animation: An animation
of the iBGStar logo will appear when
the meter is activated. This happens
by pressing the meter button or
inserting a test strip. This will not show
if you are connected to your iPhone or
iPod touch with the app launched.
(10) Battery Status (if 50% charged
or less): If the battery is 50%
charged or less, the Battery Status
symbol appears at the end of the
iBGStar animation for 1 second. The
percentage charged will be shown to
the left of the Battery Status symbol.
Example of 100% (Full) Battery Power=
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Example of 50% Battery
Power Remaining =
About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System

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How to install the iBGStar Diabetes Manager Application,
using iTunes:
The iBGStar Diabetes Manager Application (the app) can
be downloaded from the App Store. The App Store can be
accessed through iTunes or by tapping the App Store icon on
your iPhone or iPod touch. You must have internet access to
download the app.
Downloading the app through your iPhone or iPod touch:
[1] Ensure that your iPhone or iPod touch is on and the home
screen is showing.
[2] Launch the App Store application on your
iPhone or iPod touch and enter “iBGStar” into
the search box.
NOTE: Accessing the App Store requires an internet connection.
For assistance with this, visit: http://www.apple.com/support.
[3] Tap the app icon.
[4] Tap the “FREE” button, then “INSTALL.”
When prompted, sign in to your iTunes
account or create a new account if needed.
NOTE: Carrier charges may apply for downloading the app.
CHAPTER
How to Install and Update the iBGStar
Diabetes Manager Application
3
CHAPTER
How to Install and Update the iBGStar Diabetes Manager Application
Downloading the app through iTunes:
[1] Ensure you have iTunes installed on your computer, or
download it for free from: http://www.apple.com/itunes/.
[2] Launch the iTunes application.
[3] Click on “iTunes Store” in the left side of the screen.
[4] Enter “iBGStar” into the search box, located in the top right
hand corner of the screen.
[5] Locate the app icon and click “FREE” to begin
the download process. When prompted, sign in to
your iTunes account, or create a new account if
needed, and follow the onscreen instructions.
[6] Once iTunes has completed downloading the iBGStar
App, connect your iPhone or iPod touch to your computer
using the Apple Dock Connector to USB Cable. The cable was
included with your iPhone or iPod touch.
[7] On the menu on the left hand side, “Devices” will appear.
Click on your device name.
[8] At the top of the screen, click on “App”. You will see a list of
apps and an image of the device screen.
[9] Click on the “Sync app” button in the upper left of the
screen if it is not already checked.
[10] If a message appears asking if you want to sync apps, click
“Sync Apps”.
How to Install and Update the iBGStar Diabetes Manager Application

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Once inserted, your iPhone or iPod touch will display a
message asking if you’d like to install the necessary app.
Touch the “Yes” button to install the app, on your device. You
must have internet access to download the app. The app icon
and a progress bar will appear on the iPhone or iPod touch’s
screen.
How to update the app
As new features are added to the app, updates will be made
available through the App Store.
Updating the app through your iPhone or iPod touch:
[1] Anytime there is an update to an app on
your iPhone or iPod touch, a number will appear
on the App Store icon to indicate the number
of updates available. To view the updates, tap
on the App Store icon.
How to Install and Update the iBGStar Diabetes Manager Application
[11] In the list of apps, find the iBGStar Diabetes Manager
Application and check the box next to “iBGStar Diabetes
Manager.”
[12] Click “Apply” in the lower right hand corner of the screen.
[13] After syncing is done, unplug your iPhone or iPod touch
and you are ready to use the app.
These instructions are subject to change. For more information
on downloading apps from the App Store or syncing your
iPhone or iPod touch, refer to the Help section of iTunes.
How to install the app, using your iBGStar Meter:
[1] Ensure that your iPhone or iPod touch is on, and the home
screen is showing.
[2] Connect your meter to your iPhone or iPod touch by
inserting the meter’s dock connector into the iPhone or iPod
touch’s dock connector port with both displays facing up. The
dock connector port is located below the home button of
either device.
How to Install and Update the iBGStar Diabetes Manager Application

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[9] If a message appears asking if you want to Sync Apps, click
“Sync Apps.”
[10] In the list of apps, find the iBGStar App and check the box
next to “iBGStar Diabetes Manager.”
[11] Click “Apply” in the lower right hand corner of the screen.
[12] After syncing is done, unplug your iPhone or iPod touch
and you are ready to use the iBGStar App.
These instructions are subject to change. For more information
on downloading apps from the App Store or syncing your
iPhone or iPod touch, refer to the Help section of iTunes.
NOTE: Updating the app will not cause you to lose your data.
Any information currently contained in the app, such as blood
glucose readings, will not be affected by updates.
How to Install and Update the iBGStar Diabetes Manager Application
[2] Tap on the Updates icon.
[3] If there is an update available for the iBGStar Diabetes
Manager Application, it will appear in the list of updates. Tap
“Update” to update the app.
Updating the app through iTunes:
[1] Launch the iTunes application.
[2] On the left side of the screen click on “Apps” located under
the Library.
[3] If there are updates for any of your apps available, the lower
right of the screen will display that you have a number of updates
available. Click on the arrow next to “Updates Available.”
[4] If there is an update available for the iBGStar Diabetes Manager
Application, the app icon will be displayed. Click on “Get Update”
next to the icon. Enter your Apple ID and password.
[5] Once iTunes has completed downloading the app update,
connect your iPhone or iPod touch to your computer using
the Apple Dock Connector to USB Cable. The cable was
included with your iPhone or iPod touch.
[6] On the menu on the left hand side, “Devices” will appear.
Click on your device name.
[7] At the top of the screen, click on “App.” You will see a list of
apps and an image of the device screen.
[8] Click on the “Sync App” button in the upper left of the
screen if it is not already checked.
How to Install and Update the iBGStar Diabetes Manager Application

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[8] If you get repeated error messages and are experiencing
symptoms of hypo or hyperglycemia, contact your healthcare
professional immediately as this may indicate low or high glucose.
If this error code persists on retesting, consult your healthcare
professional (see C hapter 16: Error Messages and Troubleshooting)
[9] Do not use test strips that are expired or appear to b e damaged
as they may return inaccurate results.
[10]Healthcare professionals should follow their institution’s
infection control protocols.
[11] Always follow your healthcare professional’s recommendations.
The ADA recommends the following treatment goals for most
individuals with diabetes:
A1C: <7%; pre-meal glucose of 70[3.9] to 130 mg/dL, and a
glucose taken within one to two hours after the start of the meal
of < 180 mg/dL.
Treatment goals are individualized for each patient. Speak with your
healthcare provider about the target blood glucose ranges that are
right for you.
WARNING: The information from your iBGStar Diabetes
Manager Application (on your iPhone or iPod touch) and blood
glucose meter should only be used as a reference. Do not make
treatment decisions based solely on the information provided
by the app. All health-related decisions should be made in
conjunction with the advice of a qualified healthcare professional
(HCP). It is important for you and your HCP to understand how
the statistics are calculated before making any adjustments to
treatment. This information can be found in the iBGStar Diabetes
Manager Application User’s Guide available at http://ibgstar.com/
web/app or read the instructions built into the app.
Important Health-related Information
Important Health-related Information
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Please read the following:
[1] Inaccurate results may occur in severely hypotensive individuals
or patients in shock. Inaccurate low results may occur for
individuals experiencing a hyperglycemic-hyperosmolar state, with
or without ketosis. Critically ill patients should not be tested with
blood glucose meters.
[2] Severe dehydration and excessive water loss may yield
inaccurate results. If you believe you are suffering from severe
dehydration, consult your healthcare professional immediately.
[3] Patients undergoing oxygen therapy may receive inaccurate
results.
[4] Results below 70 mg/dL may mean low blood glucose levels
(hypoglycemia).
[5] Results over 240 mg/dL may mean high blood glucose levels
(hyperglycemia). Checking ketones may be advisable.
[6] If you get results below 70 mg/dL or above 240 mg/dL and do
not have symptoms of hypoglycemia or hyperglycemia, repeat
the test. If you have symptoms, or continue to get results that fall
below 70 mg/dL or rise above 240 mg/dL, follow the treatment plan
recommended by your healthcare team or contact your healthcare
professional immediately.
[7] If you are experiencing symptoms that are not consistent with
your blood glucose test and you have followed all instructions
described in this iBGStar Blood Glucose Monitoring System Owner’s
Guide, follow your healthcare professional’s recommendations.
CHAPTER
Important Health-related Information

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Important Information About Your iBGStar
Blood Glucose Monitoring System
5
CHAPTER
The iBGStar Blood Glucose Monitoring System (the meter)
should be used:
[1] For measuring blood glucose levels from fresh capillary
whole blood samples taken from the fingertip, palms (at the
base of the thumb), or forearms.
[2] For in vitro (i.e. outside of the body) diagnostic use only.
[3] With BGStar Blood Glucose Test Strips and BGStar Control
Solution only. Do not use other brands of test strips and control
solution with the meter. This may produce inaccurate results.
[4] For use at home (over the counter (OTC)) by persons with
diabetes, or in a clinical setting by healthcare professionals, as
an aid to monitor the effectiveness of diabetes control.
Do not use the iBGStar Blood Glucose Monitoring System for:
[1] The diagnosis of diabetes.
[2] Testing the glucose levels of neonates (children under 4
weeks of age).
[3] Testing glucose levels of arterial or venous blood.
[4] Testing glucose from sites other than the fingertip, palm
(at the base of the thumb), or forearm.
Important Information About Your iBGStar Blood Glucose Monitoring System
For instructions on how to use the iBG Star Diabetes Manager
Application, refer to the User’s Guide available at http://
ibgstar.com/web/app or read the instructions built into
the app.
IMPORTANT: Please note that the iBGStar Diabetes Manager
Application stores sensitive health-related information on
your iPhone or iPod touch. We recommend keeping your
iPhone or iPod touch up-to-date with the latest security
software. For more information on keeping your iPhone or
iPod touch and information safe, visit http://www.apple.com/
support/security/.
For instructions on how to use your iPhone or iPod touch,
refer to the support materials for each device.
Important Health-related Information
1American Diabetes Association; Standards of Medical Care in Diabetes
(Position Statement); Diabetes Care. 2011;34 (suppl 1):S11-S61.

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It is recommended that you use a fingertip sample if:
[1] You are testing for hypoglycemia or if you suffer from
hypoglycemia unawareness.
[2] You are testing your blood glucose within 2 hours of
eating, taking insulin, medication, exercise.
[3] Your blood glucose results obtained from the palm (at the
base of the thumb) or forearm are not consistent with the way
you feel.
CAUTION: Please read all the instructions provided in this
owner’s guide and practice the testing procedures before using
the iBGStar meter. Home blood glucose monitoring should be
done with the guidance of a health care professional.
CAUTION: To ensure accurate results, wash your hands and
the test site with warm, soapy water and dry before and
after every test. Unwashed hands and test sites may lead to
inaccurate results. Make sure there is no grease, oil or lotion
on the test site. Use lancets only once. Do not use any lancet
or lancing device that has been used by another person.
Important Information About Your iBGStar Blood Glucose Monitoring System
Possible test sites:
The iBGStar Blood Glucose Monitoring
System only requires a small droplet of
blood (0.5 μL), about the size of a
pinhead, to perform a glucose test.
For the best results, test glucose from
the tips of any finger. The palm (at the base of
the thumb) and forearm are alternative, but less
accurate, test sites. Only select soft and fleshy
areas to lance. Avoid lancing any bony areas,
obvious veins or moles.
Physiological differences in circulation between
the fingertip, palm (at the base of the thumb),
and forearm may result in differences in blood
glucose measurements between these sites.
Differences in glucose concentrations may be observed after
eating, taking insulin, or exercise. Changes in blood glucose
may be detected in the fingertips, before the palm (at the base
of the thumb) and forearm.
Important Information About Your iBGStar Blood Glucose Monitoring System

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Important Disinfection Procedures
6
CHAPTER
When using your iBGStar, avoid getting dirt, dust, blood, control
solution, water, or any other liquid into the test strip port, micro-
USB port or onto the dock connector. You should wash your
hands thoroughly after handling the meter, lancing device, or
test strips. Your meter, iPhone or iPod touch, Apple Lightning to
30-pin Adapter or Apple Lightning to 30-pin Adapter (0.2m) and
lancing device should be disinfected periodically. Cleaning and
Disinfecting will kill the bacteria and viruses that you cannot see.
Cleaning and disinfecting your iBGStar (meter), iPhone or iPod
touch, Apple Lightning to 30-pin Adapter or Apple Lightning
to 30-pin Adapter (0.2m) and Lancing Device
CAUTION: Never immerse the meter, iPhone or iPod touch, Apple
Lightning to 30-pin Adapter, Apple Lightning to 30-pin Adapter
(0.2m) or the body of the lancing device in water or any other
liquid solution. Be careful when disinfecting your meter and
iPhone or iPod touch. Avoid getting liquid into the test strip port,
micro-USB port, or onto dock connector.
When should you clean and disinfect your meter, iPhone or iPod touch,
Apple Lightning to 30-pin Adapter or Apple Lightning to 30-pin
Adapter (0.2m) and lancing device?
Since you are the only person operating them, we recommend
that you clean and disinfect once a week. If the meter is being
operated by a second person who is providing testing assistance
to the user, the meter and lancing device should be cleaned and
disinfected prior to use by the second person.The disinfection
instructions listed below were validated for 260 cleaning
disinfection cycles, for a total of 520 wipes (260 cleaning wipes
Important Disinfection Procedures
plus 260 disinfecting wipes) on the iPod touch (4th and 5th
generation), iPhone 4, and 5, Apple Lightning to 30-pin Adapter,
Apple Lightning to 30-pin Adapter (0.2m), lancing device, and
iBGStar meter. The life of the iBGStar, defined as 5,000 test strip
insertions, is between 3 to 5 years, depending on use. The number
of cleaning and disinfecting wipes used simulates cleaning and
disinfecting your meter once a week for 5 years.
What can you use to clean and disinfect your meter, iPhone or iPod
touch, Apple Lightning to 30-pin Adapter or Apple Lightning to
30-pin Adapter (0.2m) and lancing device?
See the table below for the suggested disinfecting wipe. You
should use wipes that are pre-saturated with disinfectant. Do
not immerse your meter, iPhone or iPod touch, Apple Lightning
to 30-pin Adapter, Apple Lightning to 30-pin Adapter (0.2m) or
body of the lancing device in any liquid solution.
If you suspect your meter is not working properly after disinfecting,
verify that your system is working properly by performing a control
solution test. If your control solution test result falls out of control
range, call Customer Service at 1-800-633-1610.
If you should notice any signs of deterioration on the meter,
lancing device, Apple Lightning to 30-pin Adapter, Apple
Lightning to 30-pin Adapter (0.2m), or iPhone/iPod touch (such
as clouding on the meter or iPhone/iPod touch display, corrosion
or erosion of meter, adapters, and lancing device plastic housing
or outer components of iPhone/iPod touch, or cracking of plastic
housing, display, or button) or if the meter or iPhone/iPod touch
does not turn on, or if the lancing device or adapters do not work
after cleaning and disinfection, discontinue use of the system and
contact Customer Service at 1-800-633-1610.
Availability of disinfecting wipe may vary. For updated information
you may call Customer Service at 1-800-633-1610.
Important Disinfection Procedures

28 29
EPA # Brand Name Manufacturer Available at Contact Time
9480-4* Super Sani- Professional Online: 2 Minutes
Cloth Disposables Amazon.com
Germicidal International, Officedepot.com
Disposable Inc. (PDI)
Wipe
*Active ingredient: Quaternary ammonium chlorides and isopropanol
How do you clean and disinfect your meter, iPhone or iPod touch ,
Apple Lightning to 30-pin Adapter or Apple Lightning to 30-pin
Adapter (0.2m) and lancing device?
1. Before you clean and disinfect your meter, iPhone or
iPod touch, Apple Lightning to 30-pin Adapter or Apple
Lightning to 30-pin Adapter (0.2m) and lancing device,
pre-clean the outside with a disinfecting wipe.
2. With a new disinfecting wipe, disinfect your meter,
iPhone or iPod touch, Apple Lightning to 30-pin
Adapter or Apple Lightning to 30-pin Adapter (0.2m)
and lancing device using the disinfecting wipe listed
in the table above and follow the instructions below.
In addition, follow the instructions on the disinfecting
wipe container label for safe handling of the wipes.
3. Wipe each side of your meter, iPhone or iPod touch,
Apple Lightning to 30-pin Adapter or Apple Lightning to
30-pin Adapter (0.2m) and lancing device with moderate
pressure 3 times using the following method:
a. Wipe up and down 3 times
b. Wipe left and right 3 times
c. Avoid getting disinfectant inside the test
strip port, the micro-USB port, and the dock
connector.
4. After 2 minutes of contact time, let air dry.
You should wash your hands thoroughly with soap and water
after handling the meter, lancing device, and BGStar Test Strips.
If you have any questions about cleaning and disinfecting
your iBGStar meter, iPhone or iPod touch, Apple Lightning to
30-pin Adapter or Apple Lightning to 30-pin Adapter (0.2m)
or lancing device, call Customer Service at 1-800-633-1610.
Important Disinfection Procedures Important Disinfection Procedures

30 31
Important Information About Performing
Control Solution Tests
7
CHAPTER
The iBGStar Blood Glucose Monitoring System can be used
with BGStar Control Solution (control solution).
Control solution should only be used for 90 days after first
opening the bottle or until the expiration date printed on the
label, whichever comes first.
IMPORTANT: Count forward 90 days from the date you open
a new bottle of BGStar control solution. This is your discard
date. Write the discard date on the BGStar control solution
bottle.
CAUTION: Results from control solution tests do not reect
your blood glucose level. The control solution range is a
target range for control solution only. It is not a target range
for your blood glucose level.
The control solution is used to:
[1] Ensure that your iBGStar Meter and BGStar Test Strips (test
strips) are working together properly.
[2] Practice testing without having to use your own blood.
Important Information About Performing Control Solution Tests
Control solution tests should be performed when you:
[1] First get your meter.
[2] Suspect that your meter or test strips are not working
properly.
[3] Think your test results are not accurate.
[4] Have dropped or damaged your meter or exposed your
meter to liquids.
[5] Are advised by your healthcare professional to do so.
Important BGStar Control Solution information:
[1] Use only BGStar Control Solution with your iBGStar Blood
Glucose Monitoring System.
[2] Always shake the control solution bottle before use.
[3] Always discard the first drop of control solution and wipe
the bottle tip clean using a clean tissue or paper towel.
[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 50°F to 104°F (10°C
to 40°C).
Important Information About Performing Control Solution Tests

32 33
Out-of-range test results may be caused by:
[1] Expired or defective control solution.
[2] Expired or defective test strip.
[3] Error in performing test.
[4] Watered-down control solution.
[5] Meter malfunction.
[6] Control solution test done outside the system operating
temperature of 50°F to 104°F (10°C to 40°C).
[7] Failure to shake the control solution bottle vigorously
before using.
[8] Failure to discard the first drop of control solution and to
wipe the bottle tip clean.
Important Information About Performing Control Solution Tests
How to Perform a Control Solution Test
8
CHAPTER
This chapter explains how to perform a control solution test
with the iBGStar Diabetes Manager Application (the app).
To perform a control solution test using the iBGStar Meter
independently: Skip step [1] and begin with step [2].
You must sync your meter to the app to be able to download
readings from your meter to the app and set your meter’s time
and date. For instructions on how to sync for the first time refer
to Chapter 12. Test results without a set time and date:
• Will be saved to the meter in chronological order, but will
not download to the app.
•Test results without a set time and date will be displayed on your
meter with “--:--“ and “--/--/--“ in place of the time and date.
• If have you synced your iBGStar meter to the app previously
and you see dashes in place of the time and date you need to
re-sync your meter with the app. Readings that do not have
a time and date associated with them will not download to
the app. You can manually add these readings to the app to
include them in your statistics. For best results, frequently
sync the meter with your app.
[1] Launching the App and Connecting:
Tap the iBGStar Diabetes Manager Application icon
on your iPhone or iPod touch to launch the app.
The most recent scorecard or the app’s
homescreen will be displayed.
How to Perform a Control Solution Test
Example Results:

34 35
Connect your meter to your iPhone or iPod touch by inserting
the meter’s dock connector into the iPhone or iPod touch’s
dock connector port. The dock connector port is located
below the home button of either device. Your meter and
the app will sync upon connection. The battery status and
charging battery symbol will appear on your meter’s display.
If your iBGStar meter is already connected to your iPhone
or iPod touch, then launch the iBGStar Diabetes Manager
Application to begin syncing between your meter and the app.
Note: Attaching iBGStar to an iPhone or iPod touch in the
sleep/off mode will not turn the iPhone on. The iBGStar screen
will activate and the charging icon will appear.
How to Perform a Control Solution Test
Example Results:
[2] Inserting a BGStar Test Strip:
Insert a new BGStar Test Strip into the meter’s test strip port. Make
sure you insert the test strip, with the contact bars facing towards
you, into the test strip port. The meter will be activated.
You cannot perform a test while a cable is plugged into the
micro-USB port and the meter’s battery is charging.
[3] iBGStar Meter Ready For Test:
The meter now displays the Apply Sample to Test Strip
Animation.
How to Perform a Control Solution Test
With iPhone or iPod touch: Without iPhone or iPod touch:
Apply Sample to Test Strip
Animation:

36 37
If your meter is connected to your iPhone or iPod touch and the app
is launched, the app will play an animation of a sample being applied
to a test strip.
The IBGStar Blood Glucose Monitoring System is now ready for you
to apply control solution. You do not need to set a calibration code
for the meter.
Note: If you connect your meter to your iPhone or iPod touch and
insert a test strip into the meter before launching the app, the app
will not play an animation of a sample being applied to a test strip.
If you do not start the test within 4 minutes of inserting a test strip,
the meter will display the battery status and charging symbol. To
continue testing, take out the unused BGStar Test Strip. Reinsert the
test strip into the meter. Avoid touching the test strip’s sample area
(where control solution should be applied).
[4] Applying Control Solution:
• Shake the control solution bottle.
• Discard the first drop of control solution.
• Wipe the bottle tip clean using a clean tissue or paper towel.
• Dispense a second drop onto a clean surface, such as an unused
resealable plastic bag.
• Bring the tip of the test strip to the control solution sample.
The iBGStar Blood Glucose Monitoring System will automatically
detect if a test is performed with BGStar Control Solution.
How to Perform a Control Solution Test
This is the visual
ll window. Do not
put Control
Solution here.
APPLY CONTROL
SOLUTION HERE.
[5] Remove Test Strip From Control Solution Sample When
the Test Strip’s Visual Fill Window Completely Turns Blue:
The sample applied symbol will appear on the iBGStar meter’s
screen. Your iPhone or iPod touch will beep when you should
remove the test strip from the control solution sample. It will
only beep if your meter is connected to your iPhone or iPod
touch, the app is launched, and Sounds have been activated
in the Settings menu of your iPhone or iPod touch and the
device’s volume level is audible.
The Calculating Animation (a sequence of bars and 1,2,3)
will begin on the meter display. This animation means that
a sample has been applied to the test strip and the meter is
calculating the test result.
In addition, if your meter is connected to your iPhone or iPod
touch and app, the app will display an animation showing
that the meter is calculating the test result.
How to Perform a Control Solution Test
1
The entire visual ll
window will turn blue.
Sample applied symbol:
1
2
3
Calculating Animation: