File name: 513109 Artwork, Guide,

Owners, mgdl, iBGStar, US

Revision: -
Date: 2.15.12
Operator: TM
Site/Supplier: Frankfurt Devices/
AgaMatrix
Blood Glucose Monitoring System Product Desc.: Owner’s Guide,
iBGStar Meter
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Mac format
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OWNER’S GUIDE
For use with the iBGStar Diabetes Manager

Application on iPhone ® or iPod touch ®

Key Features
iBGStar™ Diabetes Manager Application -
Blood Glucose Monitoring System
an iPhone and iPod touch application (app) Toll-Free, 24-Hour Customer Service: 1-800-633-1610
designed for the iBGStar™ Meter: The iBGStar In case of emergency, contact your healthcare professional or
Meter can easily download test results to the emergency medical response.
iBGStar Diabetes Manager Application via the By using the iBGStar Blood Glucose Monitoring System (Meter) with the
iBGStar Diabetes Manager Application (the app): You agree that the use
dock connector on the iPhone or iPod touch. of this software together with an iPod, iPhone or iPad (“Apple Product”) shall
The app can be used to conveniently store and 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
manage your diabetes information, review trends,
to replace the advice of a doctor, or your own common sense and independent
or share with your healthcare team. It can be judgment, and that you will not at any time rely on any information presented
downloaded from the App StoreSM. 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
No Coding Required: The iBGStar Meter doesn’t health care professional regarding all medical conditions, tests, diagnoses and
treatment options and agree that Apple shall have no liability for any action
require you to code the meter. Insert a BGStar® you or anyone using the software may take, regardless of the information
Test Strip and you are ready to test. 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,
“Made for iPod” and “Made for iPhone” mean that an electronic accessory has been
iPod, iPod touch, and iTunes are trademarks of Apple Inc., registered in the U.S. and other
designed to connect specifically to iPod or iPhone, respectively, and has been certified
countries. App Store is a service mark of Apple Inc. Content purchased from the iTunes
by the developer to meet Apple performance standards. Apple is not responsible for the
Store is for personal lawful use only. Don’t steal music.
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.

1
 Contents

CHAPTER TITLE PAGE CHAPTER TITLE PAGE

1 Getting Started 4 11 Obtaining a Blood Sample From Alternate Sites 56

(Palm or Forearm)
2 About the iBGStar Blood Glucose 6
Monitoring System 12 Syncing for the First Time 60

3 How to Install and Update the iBGStar Diabetes 14 13 Syncing 62

Manager Application
14 Viewing Past Test Results on the 64
4 Important Health-related Information 20 iBGStar Meter

5 Important Information About Your iBGStar 23 15 Display Messages 67

Blood Glucose Monitoring System
16 Error Messages and Troubleshooting 70
6 Important Disinfection Procedures 26
17 iBGStar Meter Battery and Charging 76
7 Important Information About Performing 30
Control Solution Tests 18 Caring for Your iBGStar Meter and 80
Lancing Device
8 How to Perform a Control Solution Test 33
19 iBGStar Meter Specifications 81
9 Important Information About Testing Your 41
Blood Glucose Level 20 Warranty 83

10 How to Test Your Blood Glucose Level 44 21 Electromagnetic Compatibility (EMC) 84

Contents

Contents
2 3
 Unpack your System Kit. Dispose of the packing material properly.

1
CHAPTER

Getting Started Charge the iBGStar Meter’s battery by following instructions in

Chapter 17.
IMPORTANT: To ensure accurate use of the iBGStar Meter (the meter)
The System Kit contains: or iBGStar Diabetes Manager Application (the app), the time and
Owner’s Guide, Reference Guide, Registration & warranty Card date must be correctly set on your iPhone or iPod touch. For
and Carrying Case (not shown) instructions on how to set the time and date on your iPhone or iPod
iBGStar Blood Glucose Dock Connector Cover touch, refer to the support materials for each device. The time and
Meter 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.
Lancing Device with Cap System requirements
(Works with most generic lancets,
Sterile Lancets such as BD Ultra-Fine™ 33 Gauge Lancets) 3 iPhone or iPod touch with at least 30 MB of available space.
x10 3 Check www.ibgstar.comwww.ibgstar.com to see which iPhone
and iPod touch, and which versions of the Apple Operating
1 Vial of 10 Test Strips Systems (iOS versions), are supported.
Clear AST Lancing Device Cap
3 Made for iPhone 3G, 3GS, 4, and 4S, iPod touch (2nd, 3rd, and
4th generation).

Power Adapter 3 For use with iPhone 5 or iPod touch (5th generation), an Apple
Lightning to 30-pin Adapter (not included in package) is required.
3 iOS 4, 5, or 6
3 The iBGStar Diabetes Manager App installed on that iPhone or
iPod touch.

Control Solution The iPhone and iPod touch are sold separately. The iBGStar Diabetes
Micro-USB to USB Cable Manager Application is not included with the iBGStar Blood Glucose
Monitoring System . It can be downloaded from the App Store on your
Getting Started

Getting Started
iPhone or iPod touch. To install the app, follow instructions in Chapter 3

4 5
 About the BGStar Blood Glucose Test Strip:

2
CHAPTER
About the iBGStar Blood Glucose
Monitoring System (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
About the iBGStar Meter (the meter) strip is facing towards you when inserting a test strip into the
meter’s test strip port.
(1) Dock Connector Cover: Covers the dock connector when
not in use. (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
(2) Dock Connector: This end inserts into the iPhone or iPod strip is facing away from you when inserting a test strip into
touch’s 30-pin dock connector port. The dock connector port the meter’s test strip port.
is located below the home button of either device.
(3) Contact Bars: This end is inserted, front of the test strip
(3) Display Area: Glucose test results, symbols and messages facing towards you, into the meter’s test strip port.
appear here.
(4) Sample Area: Blood or control solution should be applied
(4) Meter Button: The right-side of the meter’s display is a to the tip of the test strip here.
button. It is used to activate or deactivate the iBGStar and
view past test results. (5) Visual Fill Window: This window will turn red when
enough blood has been applied or blue when enough control
(5) Micro-USB Port: Used to connect to the power adapter or solution has been applied.
a PC (personal computer) via the micro-USB to USB cable.
About the iBGStar Blood Glucose Monitoring System

About the iBGStar Blood Glucose Monitoring System

(6) Test Strip Port: Insert the BGStar Blood Glucose Test Strip, 3
with the contact bars facing up, into the test strip port.
1
1 2
5

2 4
5
4
6
3
6 7
 IMPORTANT: Use BGStar Blood Glucose Test Strips only once. [9] Apply only fresh capillary blood or control solution to the
Only use BGStar Test Strips with the BGStar or iBGStar Blood sample area of the BGStar Blood Glucose Test Strip.
Glucose Monitoring System(s).

About the Micro-USB to USB Cable and Power Adapter

Important test strip information:
(1) Micro-USB to USB Cable: Used to connect the meter to
[1] Store the BGStar Blood Glucose Test Strip vial in a cool, dry the power adapter or a PC.
place at 46°F to 86°F (8°C to 30°C).
(2) Micro-USB Connector (Cable): This end inserts into the
[2] Use BGStar Blood Glucose Test Strips only within the meter’s micro-USB port.
system operating temperature range of 50°F to 104°F (10°C
to 40°C). (3) USB Connector (Cable): This end inserts into the power
adapter or a PC’s USB port.
[3] Keep away from direct sunlight and heat.
(4) Power Adapter: Used to charge your meter. It will also
[4] Store your BGStar Blood Glucose Test Strips in their original charge the iPhone or iPod touch, if the meter is connected
vial only. Never store them in another vial, any other container to the iPhone or iPod touch. Insert plug into a wall outlet
or outside the vial. (100-240v, 50-60 Hz).

[5] With clean, dry hands you may gently handle the BGStar (5) Power Adapter’s USB Port: Used to connect to the
Blood Glucose Test Strip when removing it from the vial or iBGStar meter via the micro-USB to USB cable.
inserting it into the iBGStar.
About the iBGStar Blood Glucose Monitoring System

About the iBGStar Blood Glucose Monitoring System

2
[6] After removing a BGStar Blood Glucose Test Strip from the 4
vial, immediately close the vial cap tightly.
1
[7] Do not use BGStar Blood Glucose Test Strips beyond the
expiration date or 180 days after first opening the vial. This 3
5
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.

8 9
 About the iBGStar Lancing System About the iBGStar Meter Display
and Symbols
Note: Lancing Devices and Lancets are only intended for a Example Results:
single user and should not be shared between users. (1) Glucose Test Result.
1 2 8 9
(2) Units of Measurement (scrolls
across display): Results will be
displayed in mg/dL.
6 7
(3) Time (scrolls across display):
3 4 5 Syncing will configure the time format
to match your iPhone or iPod touch’s
(1) Cocking Handle: Cocks the device so it is ready to lance. settings. The format is in either 12 or
24 Hour.
(2) Depth Adjustment Dial: Adjusts how deep the lancet will
lance the skin. (4) Date (scrolls across display):
Syncing will configure the date format
(3) Depth Indicator Window: Displays the depth setting of to match your iPhone or iPod touch’s
the lancing device. settings. The format is in either
MM/DD/YY or DD/MM/YY.
(4) Release Button: Fires the lancet.

(5) Lancet Holder Cup: Holds the lancet into place inside the (5) Control Solution Symbol:
Appears to the right of control
About the iBGStar Blood Glucose Monitoring System

About the iBGStar Blood Glucose Monitoring System

lancing device.
solution test results.
(6) Lancing Device Cap: Covers the lancet when in lancing
device. (6) Apply Sample to Test Strip
Animation: During testing, an
(7) Alternative Site Testing Cap: Used for obtaining a blood animation of a sample being applied
sample on the palm (at the base of the thumb) or forearm. to the test strip will appear on the
meter display. This means you may
(8) Lancet: Lances the skin to produce a drop of blood. apply a sample to the test strip. A
sample may either be control solution
(9) Lancet Cover: Covers the lancet for safety. Remove after or blood.
inserting into the lancet holder cup.
10 11
 (7) Sample Applied Symbol: During (11) Battery Status: Example of 60% Battery Power Remaining =
testing, this symbol will appear when Shows the amount
you should remove the test strip from of power in the
the sample. iBGStar’s battery.
Example of 100% (Full) Battery Power=
(8) Calculating Animation (“1,2,3”
countdown): During testing, an 1
animated sequence of bars and “1,2,3” 2
will appear on the meter display. This
is after a sample has been applied to 3 (12) Charging Battery Symbol:
the test strip. This means the meter Appears to the left of the Battery
is calculating the test result. Status symbol when the meter’s
battery is being charged.
(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 Example of 50% Battery

or less): If the battery is 50% Power Remaining =
About the iBGStar Blood Glucose Monitoring System

About the iBGStar Blood Glucose Monitoring System

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.

12 13
 Downloading the app through iTunes:

3
CHAPTER
How to Install and Update the iBGStar
CHAPTER

Diabetes Manager Application [1] Ensure you have iTunes installed on your computer, or
download it for free from: http://www.apple.com/itunes/.
How to install the iBGStar Diabetes Manager Application,
using iTunes: [2] Launch the iTunes application.

The iBGStar Diabetes Manager Application (the app) can [3] Click on “iTunes Store” in the left side of the screen.
be downloaded from the App Store. The App Store can be
accessed through iTunes or by tapping the App Store icon on [4] Enter “iBGStar” into the search box, located in the top right
your iPhone or iPod touch. You must have internet access to hand corner of the screen.
download the app.
[5] Locate the app icon and click “FREE” to begin
Downloading the app through your iPhone or iPod touch: the download process. When prompted, sign in to
your iTunes account, or create a new account if
[1] Ensure that your iPhone or iPod touch is on and the home needed, and follow the onscreen instructions.
screen is showing.
[6] Once iTunes has completed downloading the iBGStar
[2] Launch the App Store application on your App, connect your iPhone or iPod touch to your computer
How to Install and Update the iBGStar Diabetes Manager Application

How to Install and Update the iBGStar Diabetes Manager Application

iPhone or iPod touch and enter “iBGStar” into using the Apple Dock Connector to USB Cable. The cable was
the search box. included with your iPhone or iPod touch.

NOTE: Accessing the App Store requires an internet connection. [7] On the menu on the left hand side, “Devices” will appear.
For assistance with this, visit: http://www.apple.com/support. Click on your device name.

[3] Tap the app icon. [8] At the top of the screen, click on “App”. You will see a list of
apps and an image of the device screen.
[4] Tap the “FREE” button, then “INSTALL.”
When prompted, sign in to your iTunes [9] Click on the “Sync app” button in the upper left of the
account or create a new account if needed. screen if it is not already checked.

NOTE: Carrier charges may apply for downloading the app. [10] If a message appears asking if you want to sync apps, click
“Sync Apps”.

14 15
 [11] In the list of apps, find the iBGStar Diabetes Manager Once inserted, your iPhone or iPod touch will display a
Application and check the box next to “iBGStar Diabetes message asking if you’d like to install the necessary app.
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 Touch the “Yes” button to install the app, on your device. You
iPhone or iPod touch, refer to the Help section of iTunes. 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 install the app, using your iBGStar Meter:

[1] Ensure that your iPhone or iPod touch is on, and the home How to update the app
screen is showing.
As new features are added to the app, updates will be made
How to Install and Update the iBGStar Diabetes Manager Application

How to Install and Update the iBGStar Diabetes Manager Application

[2] Connect your meter to your iPhone or iPod touch by available through the App Store.
inserting the meter’s dock connector into the iPhone or iPod
touch’s dock connector port with both displays facing up. The Updating the app through your iPhone or iPod touch:
dock connector port is located below the home button of
either device. [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.

16 17
 [2] Tap on the Updates icon. [9] If a message appears asking if you want to Sync Apps, click
“Sync Apps.”
[3] If there is an update available for the iBGStar Diabetes
Manager Application, it will appear in the list of updates. Tap [10] In the list of apps, find the iBGStar App and check the box
“Update” to update the app. next to “iBGStar Diabetes Manager.”

Updating the app through iTunes: [11] Click “Apply” in the lower right hand corner of the screen.

[1] Launch the iTunes application. [12] After syncing is done, unplug your iPhone or iPod touch
and you are ready to use the iBGStar App.
[2] On the left side of the screen click on “Apps” located under
the Library. These instructions are subject to change. For more information
on downloading apps from the App Store or syncing your
[3] If there are updates for any of your apps available, the lower iPhone or iPod touch, refer to the Help section of iTunes.
right of the screen will display that you have a number of updates
available. Click on the arrow next to “Updates Available.”
NOTE: Updating the app will not cause you to lose your data.
[4] If there is an update available for the iBGStar Diabetes Manager Any information currently contained in the app, such as blood
Application, the app icon will be displayed. Click on “Get Update” glucose readings, will not be affected by updates.
How to Install and Update the iBGStar Diabetes Manager Application

How to Install and Update the iBGStar Diabetes Manager Application

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.
18 19
 [8] If you get repeated error messages and are experiencing

4
CHAPTER
symptoms of hypo or hyperglycemia, contact your healthcare
Important Health-related Information professional immediately as this may indicate low or high glucose.
If this error code persists on retesting, consult your healthcare
Please read the following: professional (see Chapter 16: Error Messages and Troubleshooting)
[1] Inaccurate results may occur in severely hypotensive individuals [9] Do not use test strips that are expired or appear to be damaged
or patients in shock. Inaccurate low results may occur for as they may return inaccurate results.
individuals experiencing a hyperglycemic-hyperosmolar state, with
or without ketosis. Critically ill patients should not be tested with [10] Healthcare professionals should follow their institution’s
blood glucose meters. infection control protocols.
[2] Severe dehydration and excessive water loss may yield [11] Always follow your healthcare professional’s recommendations.
inaccurate results. If you believe you are suffering from severe The ADA recommends the following treatment goals for most
dehydration, consult your healthcare professional immediately. individuals with diabetes:
[3] Patients undergoing oxygen therapy may receive inaccurate A1C: <7%; pre-meal glucose of 70[3.9] to 130 mg/dL, and a
results. glucose taken within one to two hours after the start of the meal
of < 180 mg/dL.
[4] Results below 70 mg/dL may mean low blood glucose levels
(hypoglycemia). Treatment goals are individualized for each patient. Speak with your
healthcare provider about the target blood glucose ranges that are
[5] Results over 240 mg/dL may mean high blood glucose levels right for you.
(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 WARNING: The information from your iBGStar Diabetes
the test. If you have symptoms, or continue to get results that fall Manager Application (on your iPhone or iPod touch) and blood
below 70 mg/dL or rise above 240 mg/dL, follow the treatment plan glucose meter should only be used as a reference. Do not make
treatment decisions based solely on the information provided
Important Health-related Information

Important Health-related Information

recommended by your healthcare team or contact your healthcare
professional immediately. by the app. All health-related decisions should be made in
conjunction with the advice of a qualified healthcare professional
[7] If you are experiencing symptoms that are not consistent with (HCP). It is important for you and your HCP to understand how
your blood glucose test and you have followed all instructions the statistics are calculated before making any adjustments to
described in this iBGStar Blood Glucose Monitoring System Owner’s treatment. This information can be found in the iBGStar Diabetes
Guide, follow your healthcare professional’s recommendations. Manager Application User’s Guide available at http://ibgstar.com/
web/app or read the instructions built into the app.

20 21
 For instructions on how to use the iBG Star Diabetes Manager

CHAPTER
Application, refer to the User’s Guide available at http:// Important Information About Your iBGStar
ibgstar.com/web/app or read the instructions built into Blood Glucose Monitoring System
the app.
The iBGStar Blood Glucose Monitoring System (the meter)
should be used:
IMPORTANT: Please note that the iBGStar Diabetes Manager
Application stores sensitive health-related information on [1] For measuring blood glucose levels from fresh capillary
your iPhone or iPod touch. We recommend keeping your whole blood samples taken from the fingertip, palms (at the
iPhone or iPod touch up-to-date with the latest security base of the thumb), or forearms.
software. For more information on keeping your iPhone or
iPod touch and information safe, visit http://www.apple.com/ [2] For in vitro (i.e. outside of the body) diagnostic use only.
support/security/.
[3] With BGStar Blood Glucose Test Strips and BGStar Control
Solution only. Do not use other brands of test strips and control
For instructions on how to use your iPhone or iPod touch, solution with the meter. This may produce inaccurate results.
refer to the support materials for each device.

Important Information About Your iBGStar Blood Glucose Monitoring System

[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.

Important Health-related Information

[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
1American Diabetes Association; Standards of Medical Care in Diabetes (at the base of the thumb), or forearm.
(Position Statement); Diabetes Care. 2011;34 (suppl 1):S11-S61.

22 23
 Possible test sites: It is recommended that you use a fingertip sample if:

The iBGStar Blood Glucose Monitoring [1] You are testing for hypoglycemia or if you suffer from
System only requires a small droplet of hypoglycemia unawareness.
blood (0.5 μL), about the size of a
pinhead, to perform a glucose test. [2] You are testing your blood glucose within 2 hours of
For the best results, test glucose from eating, taking insulin, medication, exercise.
the tips of any finger. The palm (at the base of
the thumb) and forearm are alternative, but less [3] Your blood glucose results obtained from the palm (at the
accurate, test sites. Only select soft and fleshy base of the thumb) or forearm are not consistent with the way
areas to lance. Avoid lancing any bony areas, you feel.
obvious veins or moles.

Physiological differences in circulation between CAUTION: Please read all the instructions provided in this
the fingertip, palm (at the base of the thumb), owner’s guide and practice the testing procedures before using
and forearm may result in differences in blood the iBGStar meter. Home blood glucose monitoring should be
glucose measurements between these sites. done with the guidance of a health care professional.
Important Information About Your iBGStar Blood Glucose Monitoring System

Important Information About Your iBGStar Blood Glucose Monitoring System

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 CAUTION: To ensure accurate results, wash your hands and
of the thumb) and forearm. 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.

24 25
 plus 260 disinfecting wipes) on the iPod touch (4th and 5th

6
CHAPTER

Important Disinfection Procedures 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
When using your iBGStar, avoid getting dirt, dust, blood, control insertions, is between 3 to 5 years, depending on use. The number
solution, water, or any other liquid into the test strip port, micro- of cleaning and disinfecting wipes used simulates cleaning and
USB port or onto the dock connector. You should wash your disinfecting your meter once a week for 5 years.
hands thoroughly after handling the meter, lancing device, or
What can you use to clean and disinfect your meter, iPhone or iPod
test strips. Your meter, iPhone or iPod touch, Apple Lightning to
touch, Apple Lightning to 30-pin Adapter or Apple Lightning to
30-pin Adapter or Apple Lightning to 30-pin Adapter (0.2m) and
30-pin Adapter (0.2m) and lancing device?
lancing device should be disinfected periodically. Cleaning and
See the table below for the suggested disinfecting wipe. You
Disinfecting will kill the bacteria and viruses that you cannot see.
should use wipes that are pre-saturated with disinfectant. Do
not immerse your meter, iPhone or iPod touch, Apple Lightning
Cleaning and disinfecting your iBGStar (meter), iPhone or iPod to 30-pin Adapter, Apple Lightning to 30-pin Adapter (0.2m) or
touch, Apple Lightning to 30-pin Adapter or Apple Lightning body of the lancing device in any liquid solution.
to 30-pin Adapter (0.2m) and Lancing Device
If you suspect your meter is not working properly after disinfecting,
CAUTION: Never immerse the meter, iPhone or iPod touch, Apple verify that your system is working properly by performing a control
Lightning to 30-pin Adapter, Apple Lightning to 30-pin Adapter solution test. If your control solution test result falls out of control
(0.2m) or the body of the lancing device in water or any other range, call Customer Service at 1-800-633-1610.
liquid solution. Be careful when disinfecting your meter and
iPhone or iPod touch. Avoid getting liquid into the test strip port, If you should notice any signs of deterioration on the meter,
micro-USB port, or onto dock connector. lancing device, Apple Lightning to 30-pin Adapter, Apple
Lightning to 30-pin Adapter (0.2m), or iPhone/iPod touch (such
When should you clean and disinfect your meter, iPhone or iPod touch, as clouding on the meter or iPhone/iPod touch display, corrosion
Apple Lightning to 30-pin Adapter or Apple Lightning to 30-pin or erosion of meter, adapters, and lancing device plastic housing
Adapter (0.2m) and lancing device? or outer components of iPhone/iPod touch, or cracking of plastic
Important Disinfection Procedures

Important Disinfection Procedures

Since you are the only person operating them, we recommend housing, display, or button) or if the meter or iPhone/iPod touch
that you clean and disinfect once a week. If the meter is being does not turn on, or if the lancing device or adapters do not work
operated by a second person who is providing testing assistance after cleaning and disinfection, discontinue use of the system and
to the user, the meter and lancing device should be cleaned and contact Customer Service at 1-800-633-1610.
disinfected prior to use by the second person.The disinfection
instructions listed below were validated for 260 cleaning Availability of disinfecting wipe may vary. For updated information
disinfection cycles, for a total of 520 wipes (260 cleaning wipes you may call Customer Service at 1-800-633-1610.

26 27
 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
4. After 2 minutes of contact time, let air dry.
How do you clean and disinfect your meter, iPhone or iPod touch ,
Apple Lightning to 30-pin Adapter or Apple Lightning to 30-pin You should wash your hands thoroughly with soap and water
Adapter (0.2m) and lancing device? after handling the meter, lancing device, and BGStar Test Strips.
1. Before you clean and disinfect your meter, iPhone or
iPod touch, Apple Lightning to 30-pin Adapter or Apple If you have any questions about cleaning and disinfecting
Lightning to 30-pin Adapter (0.2m) and lancing device, your iBGStar meter, iPhone or iPod touch, Apple Lightning to
pre-clean the outside with a disinfecting wipe. 30-pin Adapter or Apple Lightning to 30-pin Adapter (0.2m)
2. With a new disinfecting wipe, disinfect your meter, or lancing device, call Customer Service at 1-800-633-1610.
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
Important Disinfection Procedures

Important Disinfection Procedures

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.

28 29
 Control solution tests should be performed when you:

7
CHAPTER
Important Information About Performing
Control Solution Tests [1] First get your meter.

The iBGStar Blood Glucose Monitoring System can be used [2] Suspect that your meter or test strips are not working
with BGStar Control Solution (control solution). properly.

Control solution should only be used for 90 days after first [3] Think your test results are not accurate.
opening the bottle or until the expiration date printed on the
label, whichever comes first. [4] Have dropped or damaged your meter or exposed your
meter to liquids.
IMPORTANT: Count forward 90 days from the date you open
a new bottle of BGStar control solution. This is your discard [5] Are advised by your healthcare professional to do so.
date. Write the discard date on the BGStar control solution
bottle.
Important BGStar Control Solution information:
CAUTION: Results from control solution tests do not reflect
your blood glucose level. The control solution range is a [1] Use only BGStar Control Solution with your iBGStar Blood
target range for control solution only. It is not a target range Glucose Monitoring System.
for your blood glucose level.
Important Information About Performing Control Solution Tests

Important Information About Performing Control Solution Tests

[2] Always shake the control solution bottle before use.

The control solution is used to: [3] Always discard the first drop of control solution and wipe
the bottle tip clean using a clean tissue or paper towel.
[1] Ensure that your iBGStar Meter and BGStar Test Strips (test
strips) are working together properly. [4] Replace the cap on the control solution bottle immediately
after use.
[2] Practice testing without having to use your own blood.
[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).

30 31
 Out-of-range test results may be caused by:

CHAPTER
How to Perform a Control Solution Test
[1] Expired or defective control solution.

[2] Expired or defective test strip. This chapter explains how to perform a control solution test
with the iBGStar Diabetes Manager Application (the app).
[3] Error in performing test.
To perform a control solution test using the iBGStar Meter
independently: Skip step [1] and begin with step [2].
[4] Watered-down control solution.
You must sync your meter to the app to be able to download
[5] Meter malfunction. 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
[6] Control solution test done outside the system operating to Chapter 12. Test results without a set time and date:
temperature of 50°F to 104°F (10°C to 40°C). • Will be saved to the meter in chronological order, but will
not download to the app.
[7] Failure to shake the control solution bottle vigorously • Test results without a set time and date will be displayed on your
before using. meter with “--:--“ and “--/--/--“ in place of the time and date.
• If have you synced your iBGStar meter to the app previously
[8] Failure to discard the first drop of control solution and to and you see dashes in place of the time and date you need to
wipe the bottle tip clean. re-sync your meter with the app. Readings that do not have
Important Information About Performing Control Solution Tests

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.
Example Results:

How to Perform a Control Solution Test

[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.
32 33
 Connect your meter to your iPhone or iPod touch by inserting [2] Inserting a BGStar Test Strip:
the meter’s dock connector into the iPhone or iPod touch’s Insert a new BGStar Test Strip into the meter’s test strip port. Make
dock connector port. The dock connector port is located sure you insert the test strip, with the contact bars facing towards
below the home button of either device. Your meter and you, into the test strip port. The meter will be activated.
the app will sync upon connection. The battery status and With iPhone or iPod touch: Without iPhone or iPod touch:
charging battery symbol will appear on your meter’s display.

Example Results:

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:

If your iBGStar meter is already connected to your iPhone The meter now displays the Apply Sample to Test Strip
or iPod touch, then launch the iBGStar Diabetes Manager Animation.
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. Apply Sample to Test Strip
Animation:
How to Perform a Control Solution Test

How to Perform a Control Solution Test

34 35
 If your meter is connected to your iPhone or iPod touch and the app [5] Remove Test Strip From Control Solution Sample When
is launched, the app will play an animation of a sample being applied the Test Strip’s Visual Fill Window Completely Turns Blue:
to a test strip.
1
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 The entire visual fill
window will turn blue.
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.
Sample applied symbol:
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 The sample applied symbol will appear on the iBGStar meter’s
test strip into the meter. Avoid touching the test strip’s sample area screen. Your iPhone or iPod touch will beep when you should
(where control solution should be applied). remove the test strip from the control solution sample. It will
[4] Applying Control Solution: only beep if your meter is connected to your iPhone or iPod
• Shake the control solution bottle. touch, the app is launched, and Sounds have been activated
• Discard the first drop of control solution. in the Settings menu of your iPhone or iPod touch and the
• Wipe the bottle tip clean using a clean tissue or paper towel. device’s volume level is audible.
• Dispense a second drop onto a clean surface, such as an unused
resealable plastic bag. The Calculating Animation (a sequence of bars and 1,2,3)
• Bring the tip of the test strip to the control solution sample. will begin on the meter display. This animation means that
a sample has been applied to the test strip and the meter is
This is the visual
calculating the test result.
Calculating Animation:
fill window. Do not
1
How to Perform a Control Solution Test

How to Perform a Control Solution Test

put Control
Solution here.
2
APPLY CONTROL
3
SOLUTION HERE.
In addition, if your meter is connected to your iPhone or iPod
touch and app, the app will display an animation showing
The iBGStar Blood Glucose Monitoring System will automatically that the meter is calculating the test result.
detect if a test is performed with BGStar Control Solution.
36 37
 [6] Viewing Control Solution Test Result: If your control solution test results are out of the range, repeat
The control solution test result will appear on the meter display. the test and refer to Chapter 8 of this guide to see potential
causes of error. If the results from the control solution tests
The unit of measure (mg/dL), time and date of testing will continue to fall outside that range, do not use the iBGStar
scroll to the right of the control solution test result. The Blood Glucose Monitoring System to test your blood glucose.
control solution symbol will appear next to the test result. The Call Customer Service at 1-800-633-1610. The phone number
control solution test result is stored in the meter’s memory. is also printed on your iBGStar meter’s cap label.
Example Results:
[7] Remove the Used BGStar Test Strip From the iBGStar
Meter’s Test Strip Port:
The control solution test result scorecard will be downloaded
to the app on your iPhone or iPod touch. The battery status
and charging battery symbol will appear on the meter’s display.
In addition, if the meter is connected to an iPhone or iPod Example Results:
touch and the app is launched, the control solution test result
scorecard will appear on the iPhone or iPod touch’s screen.

Compare the result of your control solution test to the range

printed on your BGStar Blood Glucose Test Strip vial label. Be
sure you look at the range for the control solution level (Level
2 or Level 4) that you used. Your control solution result should
fall within this range. When using your iBGStar meter independently, removing
the used test strip will deactivate your meter. When using
your meter with the app closed, removing the used test strip
EXAMPLE: will make your meter display the battery status and charging
Level 2: 90-150 mg/dL symbol.
How to Perform a Control Solution Test

How to Perform a Control Solution Test

Level 4: 220-320 mg/dL
FOR EXAMPLE ONLY.
All test result scorecards in the app that have been
Refer to your test downloaded from the iBGStar meter will have a Lock
strip vial label for
corresponding range.
icon in the upper left corner (in place of the Delete
icon). The Lock icon indicates that the control solution value
and associated time and date cannot be deleted or edited.
EXAMPLE:

38 39
 To disconnect your meter from the iPhone or iPod touch, hold

CHAPTER
your iPhone or iPod touch firmly with one hand and use your Important Information About Testing
other hand to pull your meter away from the iPhone or iPod Your Blood Glucose Level
touch. Your meter will deactivate.
Example Results: CAUTION: To ensure accurate results, wash your hands and
the test site with warm, soapy water and dry before 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.

WARNING:

[8] Dispose of Used Materials Properly. Follow your [1] Do not sync the app on your iPhone or iPod touch with an
healthcare provider’s instructions for disposal. iBGStar used by another person. Data downloaded from the
iBGStar meter cannot be deleted from the iBGStar Diabetes
Manager Application. If you sync with another person’s
meter, the data from each meter will be combined in the app
and may give you incorrect reports.

Important Information About Testing Your Blood Glucose Level

[2] Never share your iBGStar meter with another person.
Individual results cannot be deleted from the iBGStar meter.
If another person performs a blood glucose test on your
iBGStar meter and you sync to the app installed on your
iPhone or iPod touch, the data will be combined in the app
How to Perform a Control Solution Test

which may give you incorrect reports.

40 41
 IMPORTANT: WARNING:

[1] Remove the test strip from the blood sample as soon as the The lancing device and lancets should only be used by
test strip’s visual fill window completely turns red. one person. Never share lancing devices or lancets. Used
test strips, lancets, and lancing devices may be considered
[2] Do not press the BGStar Test Strip against the test site. biohazardous or medical waste in your city or town. Follow
your healthcare provider’s instructions for disposal.
[3] Do not scrape blood onto the BGStar Test Strip.

[4] Do not apply blood to the top side of the BGStar Test Strip.

[5] Do not apply blood to the BGStar Test Strip when the test
strip is out of the meter.

[6] Do not put blood or foreign objects into the iBGStar test
strip port.

[7] Do not apply more blood after the test strip’s visual fill
window completely turns red and the Calculating Animation
(a sequence of bars and 1,2,3) begins on the meter’s display.
Important Information About Testing Your Blood Glucose Level

Important Information About Testing Your Blood Glucose Level

[8] Carefully read the test results on the meter screen before
making any treatment decisions.

42 43
 Snap off the cap from the lancing device.

10
CHAPTER
How to Test Your
Blood Glucose Level

This chapter explains how to perform a test with the iBGStar

Diabetes Manager Application.
To perform a blood glucose test using the iBGStar Meter Insert New Lancet:
independently: Skip step [2]. Insert a new lancet firmly into the lancet holder cup as
shown in the picture below. Pushing the lancet into the
You must sync your meter to the app to be able to download
lancet holder cup may cock the device; this is OK.
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 iBGStar meter in chronological order but will
not download to the app.
• Test results without a set time and date will be displayed on your
Twist the Lancet Cover Off:
meter with “--:--“and “--/--/--“ in place of the time and date.
Hold the lancet firmly in place with one hand and use your
Example Results: other hand to twist off the lancet cover. Keep the lancet cover.
--/--/-- It should be used when discarding your used lancet.
--:--

If have you synced your iBGStar meter to the app previously and Replace Lancing Device Cap:
you see dashes in place of the time and date you need to re-sync Replace the lancing device cap until it snaps into place. Be
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

your meter with the app. Readings that do not have a time and careful not to touch the exposed needle on the lancet.
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] Preparing the BGStar Lancing Device:
Use the gray cap for testing on a fingertip and the clear cap for
testing on the palm (at the base of the thumb) or forearm.
Remove Lancing Device Cap:
44 45
 Set the Lancing Level: Connect your meter to your iPhone or iPod touch by inserting
The BGStar Lancing Device offers 8 depth settings. Rotate the the meter’s dock connector into the iPhone or iPod touch’s dock
dial to the desired setting as shown in the depth indicator connector port. The dock connector port is located below the home
window. Level 1 is the shallowest; level 8 is the deepest. If you button of either device. Your meter and the app will sync upon
have never lanced before, it is recommended that you start at connection. The battery status and charging battery symbol will
level 3. appear on your meter’s display.
Example Results:

Cock the Handle:

Pull the cocking handle out until it clicks. You may have
already cocked the handle accidentally while inserting the
lancet; this is OK. The lancing device is now ready for use. If your iBGStar meter is already connected to the iPhone or iPod
touch, then launch the app to begin syncing between your meter
and the app.
[3] Insert a New BGStar Test Strip:
Insert a new BGStar Test Strip into the meter’s test strip port. Make sure
[2] Launching the App and Connecting (Skip to step [3] if you insert the test strip, with the contact bars facing towards you, into
testing without the app): the test strip port. You cannot perform a test while a cable is plugged
Tap the iBGStar Diabetes Manager Application icon on your into the micro-USB port and the meter’s battery is charging.
iPhone or iPod touch to launch the app. The app will display
With iPhone or iPod touch: Without iPhone or iPod touch:
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

the most recent scorecard.

46 47
 Do not perform a test while a cable is plugged into the micro- [5] Lancing:
USB port and the meter’s battery is charging. The meter cannot To ensure accurate results, wash hands with warm, soapy
perform a test while it is charging with the cable. water and dry before every glucose test.
[4] Meter Ready For Test:
For details on possible test sites, refer to Chapter 5. For
The meter now displays the Apply Sample to Test Strip Animation.
instructions on how to test on your palm or forearm, please
refer to Chapter 11.
Apply Sample to Test Strip Keep your hand warm or gently massage the site you are
Animation:
lancing to stimulate blood flow.

Lance Test Site:

• Press the lancing device against the site to be lanced.
• Press the release button.

If your meter is connected to your iPhone or iPod touch

and the app is launched, the app will play an animation of a Release
sample being applied to a test strip. Button
The iBGStar Blood Glucose Monitoring System is now ready Obtain a Drop of Blood:
for you to apply blood. You do not need to set a calibration • Wipe away the first blood drop that appears using a clean
code for the meter. tissue or paper towel.
If you connect your meter to your iPhone or iPod touch and • Squeeze from the base of your finger up towards the tip,
insert a test strip into the meter before launching the app, the until a second small blood drop forms. Do not squeeze
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

app will not play an animation of a sample being applied to a directly around the lanced area.
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 and reinsert it into the meter. Avoid touching the test
strip’s sample area (where blood should be applied).
48 49
 [6] Applying Blood Sample: [7] Remove Your Finger From the Test Strip When the Test
The meter should still display the Apply Sample to Test Strip Strip’s Visual Fill Window Completely Turns Red:
Animation. Test in progress...

((BEEP))
Apply Sample to Test Strip
Animation:

The entire visual fill

window must turn red.

WARNING: If the visual

fill window does not
completely fill, you may
get an inaccurate result.
The sample applied symbol will appear Retest and ensure that
on the meter’s screen and your iPhone or the visual fill window is
completely full.
iPod touch will beep when you should
Bring Test Strip to Blood Sample:
remove the test strip from the blood sample. It will only
• Immediately bring the BGStar Test Strip to the blood
beep when sound is enabled and your meter is connected
sample. The test strip fills from the tip. Do not try to
to your iPhone or iPod touch, the app is launched, and the
smear blood on the top surface.
device’s volume level is audible.
Sample applied symbol:
This is the visual
fill window. Do not The Calculating Animation (a sequence of bars
apply blood here.
and 1,2,3) will begin on the meter display.
This animation indicates that a sample has
APPLY BLOOD HERE. been applied to the test strip and the meter
is calculating the test result.
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

In addition, if the meter is connected to an
The BGStar Test Strip acts like a sponge and draws the blood iPhone or iPod touch and the app is launched,
into the test strip through the sample area. The visual fill the app will display an Calculating Animation:
window of the BGStar Test Strip will turn red. animation showing
that the meter is 1
calculating the test 2
result. 3
50 51
 [8] Viewing Blood Glucose Test Result: Example Result: Refer to the iBGStar Diabetes Manager Application User’s
The blood glucose test result will appear Guide for more information on mealtime tags and the Meal
on the meter display. Schedule settings. Any test performed when using the Meter
independently will not be assigned a mealtime tag when it is
The unit of measure (mg/dL), time and
synced with the app.
date of testing will scroll to the right of
the blood glucose test result. The test Test result scorecards containing data downloaded
result is stored in the meter’s memory. from the iBGStar meter will have a Lock icon in the
In addition, if the meter is connected to an upper left corner (in place of the Delete icon). The Lock
iPhone or iPod touch and the app is launched, icon indicates that the blood glucose value and associated
the scorecard with reading will appear on time and date cannot be deleted or edited. Carbs, Insulin, Tag,
the iPhone or iPod touch’s screen. and Notes can still be added or edited for these scorecards. To
learn how to edit your Carbs, Insulin, Tag, and Notes refer to
the iBGStar Diabetes Manager Application User’s Guide.
[9] Remove the Used BGStar Test Strip
From the iBGStar Meter’s Test Strip Port: To disconnect the meter from the iPhone or iPod touch, hold
Avoid touching the test strip’s sample the iPhone or iPod touch firmly with one hand and use your
Example Result: other hand to pull the meter away from the iPhone or iPod
area (where blood was applied). The blood
glucose test result scorecard will be touch. Your meter will deactivate.
downloaded to the app on your iPhone
or iPod touch. The battery status and Example Result:
charging battery symbol will appear on
the meter’s display.
When using your iBGStar meter
independently, removing the used
test strip will deactivate your meter.
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

To manually deactivate the meter
press and hold the meter button
until the meter deactivates.
When using your meter with the app
closed, removing the used test strip
will make your meter display the battery
status and charging symbol.
52 53
 [10] Final Steps: Replace the lancing device cap onto the lancing device until it
Remove the Lancet: snaps or clicks into place.
When you have finished testing, snap off the cap from the
lancing device. Be careful not to touch the lancet tip.

Discard the used BGStar Test Strip and lancet properly. Follow
your healthcare providers instructions for disposal.

Place the lancet cover onto a hard, even surface (such as a

tabletop) with the open-end facing up. While the lancet is still
in the lancing device, bring the lancet tip to the lancet cover
to recover the used lancet. You can then safely handle the
used lancet.

Wash your hands thoroughly with soap and water after

handling the meter, lancing device, and test strips. If the
meter is being operated by a second person who is providing
testing assistance to the user, disinfect the meter following
the instructions in Chapter 6.
How to Test Your Blood Glucose Level

How to Test Your Blood Glucose Level

Extract the lancet from the lancet holder cup by pulling on
the plastic collar of the lancet (near the middle of the lancet).

54 55
 CAUTION:

11
CHAPTER
Obtaining a Blood Sample From To ensure accurate results, wash your hands with warm, soapy
Alternative Sites (Palm or Forearm) water and dry before every test. Clean and make sure there is
no grease, oil or lotion on the test site.
Testing glucose levels with blood obtained from the palm
(at the base of the thumb) or forearm may reduce the Follow Chapter 9, steps 1-4, to begin blood glucose testing.
pain of testing. The technique for testing on the palm and
forearm is slightly different than testing on the finger. Always
discuss changes to your testing habits with your healthcare [1] Prepare the Lancing Device:
professional. Replace the gray lancing device cap with the clear cap.

IMPORTANT: When testing on the palm (at the base of the

thumb) or forearm, you may need to set the lancing device
to a deeper setting or use a larger lancet to obtain enough
blood to perform a test. Consult your healthcare professional
for a recommendation.

When testing on alternative sites always use the clear lancing

device cap that has been specially designed for this purpose.
The clear plastic allows you to see a blood drop form without
Obtaining a Blood Sample From Alternative Sites (Palm or Forearm)

Obtaining a Blood Sample From Alternative Sites (Palm or Forearm)

removing the lancing device and the concave tip aids in the
collection of a blood sample.

56 57
 [2] Rub Test Site: [4] Obtain a Drop of Blood: After lancing, hold the lancing
To increase the blood flow in your palm (at the base of the device against your skin until a blood droplet forms. Do not
thumb) or forearm, rub the area that you will be testing. squeeze directly around the lanced area. Make sure the blood
Ensure that your palm or forearm is facing up and held level. drop is large enough to completely fill the visual fill window
of the test strip. Pull the lancing device directly off your palm
Palm: Forearm: or forearm to ensure that you do not smear the blood drop.

Palm: Forearm:

[3] Lance Test Site:

Press the tip of the clear cap against your skin on the palm of
your hand (at the base of the thumb) or forearm. Hold the tip to Return to Chapter 10, step 6 to continue with testing
the test site for a few seconds. Then press the release button. instructions.
Obtaining a Blood Sample From Alternative Sites (Palm or Forearm)

Obtaining a Blood Sample From Alternative Sites (Palm or Forearm)

Palm: Forearm:

58 59
 If your meter is already connected to the iPhone or iPod touch,

12
CHAPTER

Syncing for the First Time then launch the app. If you have an iPhone or iPod touch
with a Lightning Connector, (ie, iPhone 5 or iPod touch 5),
an adapter is necessary to sync your iBGStar meter with the
Before syncing for the first time, the iBGStar Diabetes Manager app. The Apple Lightning Adapter or Apple Lightning Cable
Application must be installed on your iPhone or iPod touch. Adapter (0.2m) are the recommended adapters for syncing
For instructions on installing the app refer to Chapter 3. your iBGStar Meter to the app:
[1] Insert the Lightning Adapter into the iPhone or iPod touch
Ensure that the time and date is properly set on your iPhone Lightning Connector.
or iPod touch before syncing your meter to the app. For [2] Insert the iBGStar meter into the Lightning Adapter
instructions on how to set the time and date on your iPhone or (already attached to the iPhone or iPod touch).
iPod touch, refer to the support materials for each device.
The first time you connect an iBGStar meter to the iBGStar
Tap the iBGStar Diabetes Manager Application icon on your App on your iPhone or iPod touch, you will be prompted with
iPhone or iPod touch to launch the app. a message. It will ask if you want to download readings from
this meter.

Select “Sync” to download data from the meter to the app

on your iPhone or iPod touch. The app will begin syncing
with your meter. During every sync, any new data will be
Connect your meter to your iPhone or iPod touch by inserting downloaded from the meter to the app. Syncing will also set
the iBGStar Meter’s dock connector into the iPhone or iPod the meter to match the iPhone or iPod touch’s time and date.
touch’s dock connector port. The dock connector port is
located below the home button of either device. Select “Cancel” to cancel the download. The meter will not
Example Result: sync with the app. You may disconnect the meter from the
iPhone or iPod touch.

You must sync your iBGStar meter to the iBGStar Diabetes

Manager Application to set your meter’s time and date to be
Syncing for the First Time

Syncing for the First Time

able to download readings from your meter to the app.

60 61
 During every sync:

13
CHAPTER

Syncing
3 Any new data with a time and date will be downloaded
from the meter to the app.
The first time you connect an iBGStar meter to the app on your
iPhone or iPod touch, you will be prompted with a message. If 3 The meter is configured to match the iPhone or iPod
this is your first time connecting the meter, follow instructions touch’s time and date.
in Chapter 12.
3 The meter’s battery will charge.
After the first sync between an iBGStar Meter and the
app, syncing will happen automatically when:
All test result scorecards in the iBGStar Application
3 You connect the meter to your iPhone or iPod touch with data that has been downloaded from the iBGStar
with the app launched. meter will have a Lock icon in the upper left corner
(in place of the Delete icon). The Lock icon indicates that the
3 You launch the app with your meter already connected to test result value and associated time and date cannot be
the iPhone or iPod touch. deleted or edited. Carbs, Insulin, Tag, and Notes can still be
added or edited for blood glucose scorecards. To learn how
to edit your Carbs, Insulin, Tag, and Notes refer to the iBGStar
Ensure that the time and date is properly set on your iPhone Diabetes Manager Application User’s Guide.
or iPod touch before syncing your meter to your iPhone or
iPod touch. For instructions on how to set the time and date If you disconnect the meter from the iPhone or iPod touch
on your iPhone or iPod touch, refer to the support materials during a sync, all new data may not completely download and
for each device. The time and date from your iPhone or iPod the meter’s time and date may not match the iPhone or iPod
touch will be used to set the time and date on your meter touch’s time and date.
whenever it syncs.
Syncing

Syncing
62 63
 If it was a control solution test result, the control solution icon

14
CHAPTER
Viewing Past Test Results on the will appear to the right of the test result. In this case, a symbol
iBGStar Meter will not appear to the right of the result.

The iBGStar Blood Glucose meter will store up to 300 of the [2] Viewing all stored test results:
most recent blood glucose and control solution test results Press and release the meter button to view the next most
with time and date. When the meter needs to save a new test recent test result. The date, time, and mg/dL unit of measure
result and has already stored 300 test results, the oldest test will scroll to the right of the test result.
result will be deleted and a new test result will be saved. Example Results:

In order to view stored test results on your iBGStar meter:

A) The meter must be disconnected from the iPhone or

iPod touch.
Continue to press and release the meter button to view every
OR
test result, starting from the most recent and ending with the
B) The meter is connected to the iPhone or iPod touch oldest.
with the iBGStar Diabetes Manager Application closed. Example Results:

You cannot access the iBGStar meter’s memory if it is connected

to the iPhone or iPod touch with the app launched or if a test
strip is inserted into the meter. In this case past results can be
viewed in the app.
To return to the most recent test result, deactivate your
Viewing Past Test Results on the iBGStar Meter

Viewing Past Test Results on the iBGStar Meter

[1] Viewing the most recent test result: iBGStar meter by pressing and holding the meter button until
Press and release the meter button once. The iBGStar meter the meter deactivates. Then reactivate the meter by pressing
will display the most recent test result and will be indicated and releasing the meter button once.
by a symbol to the right of the result. The date, time, and
mg/dL unit of measure will scroll to the right of the test result. When you’ve reached the oldest (last) test result saved, press
Example Results:
and release the meter button once to revert back to the most
recent test result. A short animation (arrow cycling counter-
clockwise) representing this transition will appear on the
meter display.

64 65
 15

CHAPTER
Display Messages

Messages occurring while a test strip is inserted are

[3] Deactivate your iBGStar meter: displayed until the test strip is removed or when the meter
When using your meter independently, press and hold the automatically deactivates. Messages occurring when no test
meter button until the meter deactivates. If the meter is left strip is inserted are displayed for 5 seconds and then the
inactive for 1 minute it will automatically deactivate. meter will deactivate, unless a new test strip is inserted.

If you are viewing past results while the meter is connected to CAUTION: Low or high blood glucose test results can
the iPhone or iPod touch with the app closed, the meter will indicate a potentially serious medical condition. Follow your
display the battery status and charging symbol after 1 minute healthcare professional’s recommendations. These results
of inactivity. If the iPhone or iPod touch is hibernating (when represent meter operating range. Consult your healthcare
the device is on and the touch screen is locked or off) the professional for appropriate target ranges.
meter will deactivate.

To disconnect your meter from your iPhone or iPod touch, LOW MESSAGE:
hold the iPhone or iPod touch firmly with one hand and use
your other hand to pull your meter away from the iPhone or MEANING: Glucose test result is lower than 20 mg/dL. This low
iPod touch. Your meter will deactivate. result may indicate hypoglycemia (low blood glucose). The low
result is stored in the iBGStar meter. On the app it will be saved
as a test result of < 20 mg/dL with time and date. The value will
be represented as 20mg/dL in the statistics in the app.
Viewing Past Test Results on the iBGStar Meter

ACTIONS: If you feel symptoms such as weakness, sweating,

nervousness, headache or confusion, follow your healthcare
professional’s recommendations. If you get a low glucose test
result but have no symptoms of low blood glucose, then retest
with a new BGStar Test Strip. If you still get a low test result,
follow the treatment plan recommended by your healthcare

Display Messages
team or contact your healthcare professional immediately.

66 67
 ACTIONS: Move to an area with an ambient temperature of
HIGH MESSAGE: 50°F to 104°F (10°C to 40°C). Wait for the meter and test strips
to reach the new temperature (usually 10-20 minutes) before
MEANING: Glucose test result is above 600 mg/dL. This high
using the meter or performing a test.
result may indicate hyperglycemia (high blood glucose). The
high result is stored in the meter. On the app it will be saved
as a test result of > 600 mg/dL with time and date. The value
LOW BATTERY MESSAGE:
will be represented as 600 mg/dL in the statistics in the app.
This message appears for 2 seconds.
ACTIONS: If you feel symptoms such as fatigue, thirst,
excessive urination, or blurry vision, follow your healthcare MEANING: The battery in your meter is low on power.
professional’s recommendations. If you get a high glucose
test result but have no symptoms of high blood glucose, ACTIONS: If the battery symbol appears, the battery in your
then retest with a new BGStar Test Strip. If you still get a high meter must be charged. For details about charging your
glucose test result, follow your healthcare professional’s meter, refer to Chapter 17.
recommendations. Checking ketones may be advisable.

LOW TEMPERATURE MESSAGE: DEAD BATTERY MESSAGE:

MEANING: The iBGStar Blood Glucose Monitoring System MEANING: The battery in your meter does not have enough
is below its operating temperature range of 50°F to 104°F power to activate your meter and perform a test.
(10°C to 40°C).
ACTIONS: Move to an area with an ambient temperature of ACTIONS: If the dead battery symbol appears, the battery in
50°F to 104°F (10°C to 40°C). Wait for the meter and test strips your meter must be charged. For details about charging your
to reach the new temperature (usually 10-20 minutes) before meter, refer to Chapter 17.
using the meter or performing a test.

HIGH TEMPERATURE MESSAGE:

MEANING: The iBGStar Blood Glucose Monitoring System
is above its operating temperature range of 50°F to 104°F
(10°C to 40°C).
Display Messages

Display Messages
68 69
 Error 1: Problems have occurred that are

16
CHAPTER

Error Messages and Troubleshooting related to test strip use.

[1] If this message appears the moment the test strip is inserted,
the test strip may be wet or damaged. Retest using a new test strip.
The iBGStar Blood Glucose Monitoring System has been
designed to work accurately under most usual conditions. On [2] If the message appears during a test, the test strip may have
rare occasions, the meter will display an error message instead been removed too early. Retest using a new test strip.
of a glucose result. [3] If this message appears after the last progress bar instead of a
In addition, if the meter is connected to an iPhone or iPod result, it may indicate that you applied more blood after testing
touch and the iBGStar Application is launched, the app will began. Retest using a new test strip.
display the error message.
Error 2: The iBGStar meter has detected an
The iBGStar Blood Glucose Monitoring System is able to detect irregularity with the sample.
specific problems which may allow you to determine the cause
of the error without wasting valuable test strips. When you are [1] The test strip may be partially filled. You should check the
presented with an error message, check for possible problems window of the test strip to confirm that it is full. Retest using
related to each message listed in this chapter. a new test strip. Ensure that enough whole blood is applied to
the test strip when retesting.
Error messages occurring while a test strip is inserted are
displayed until the test strip is removed or when the meter [2] The sample may not be blood or control solution. Retest
automatically deactivates. Error messages occurring when no using a new test strip. Ensure that the test site is clean prior to
test strip is inserted are displayed for 5 seconds and then the performing a blood glucose test or that the control solution
meter will deactivate, unless a new test strip is inserted. bottle tip is wiped clean prior to performing a control solution
test.
CAUTION: In certain cases, the meter may return an error code
or provide an inaccurate result if it is being used near electrical Error 3: The meter has detected that the
equipment, like a power generator or a computer monitor.
Error Messages and Troubleshooting

Error Messages and Troubleshooting

test strip is in poor condition.
CAUTION: If you get repeated error messages and are [1] The test strip may have been improperly stored (e.g. hot,
experiencing symptoms of hypo or hyperglycemia, humid conditions) or may be expired. Check the test strip vial for
contact your healthcare professional immediately as this the expiration date. Do not use test strips beyond the expiration
may indicate low or high glucose. If this error code persists date or 180 days after first opening the vial. You may need to
on retesting, consult your healthcare professional. retest using a new test strip from a new vial of test strips.

70 71
 [2] The test strip may have been mishandled by vigorous bending Error 6: The test strip has taken too long to
or shaking. Retest using a new test strip. generate a signal.
[3] Parts of the test strip may have become covered in grease, oil,
[1] This may be caused by a combination of cold operating
or lotion. Retest using a new test strip.
temperature and high hematocrit levels. Retest in a warmer
[4] The test strip port connector may be dirty. Call Customer location.
Service for assistance at 1-800-633-1610. The phone number
is also printed on your meter’s cap label. [2] If this error code persists on retesting, call Customer Service
at 1-800-633-1610. The phone number is also printed on your
Error 4: The meter was unable to produce meter’s cap label.
a result or unusual test strip problems have
occurred that may be related to extreme conditions.
Error 7: iBGStar meter problems have
[1] This error may be caused by extremely high glucose. If you occurred that are beyond your control.
are experiencing symptoms of hyperglycemia, contact your Call Customer Service for assistance at 1-800-633-1610.
healthcare professional immediately. If this error code persists on The phone number is also printed on your meter’s cap label.
retesting, consult your healthcare professional.
[2] Retest where it is closer to a room temperature of 70°F to 75°F
(21°C to 24°C). Error 8: A problem has occurred related to
the meter hardware.
Error 5: The meter was unable to produce
[1] This may be caused by connecting a power adapter to
a reliable result.
the meter while testing. Disconnect the power adapter and
[1] This may be caused by a non-blood sample, or a combination retest.
of high glucose and other medical conditions.
[2] If this error code persists on retesting, consult your healthcare [2] If this error code persists on retesting, contact Customer
Error Messages and Troubleshooting

Error Messages and Troubleshooting

professional. Service at 1-800-633-1610. The phone number is also printed
on your meter’s cap label.

72 73
 Troubleshooting Situation #1: [2] CAUSE: Sample was applied after 4 minutes of inserting
Meter does not display the Apply Sample to Test Strip a test strip.
Animation after inserting a BGStar Test Strip. ACTION: Repeat the test using a new BGStar Test Strip.
Wait until you see the Apply Sample to Test Strip Animation
[1] CAUSE: The meter’s battery has insufficient power. appear on the meter display screen before you apply the
ACTION: The meter’s battery must be charged immediately. blood sample.
For details about charging your meter, refer to Chapter 18.
[3] CAUSE: Defective meter.
[2] CAUSE: The BGStar Test Strip has been inserted upside ACTION: Call Customer Service at 1-800-633-1610. The phone
down, wrong end in, or incompletely inserted into the meter. number is also printed on your meter’s cap label.
ACTION: Remove the test strip from the meter’s test strip port.
Reinsert the BGStar Test Strip with the black side up and the
end of the test strip with contact bars inserted up into the
meter’s test strip port. Ensure that the test strip is fully inserted.

[3] CAUSE: Defective meter or defective test strips.

ACTION: Call Customer Service at 1-800-633-1610. The phone
number is also printed on your meter’s cap label.

[4] CAUSE: Blood or foreign objects put into the meter test
strip port.
ACTION: Call Customer Service at 1-800-633-1610. The phone
number is also printed on your meter’s cap label.

Troubleshooting Situation #2: After applying the blood

Error Messages and Troubleshooting

Error Messages and Troubleshooting

sample, the iBGStar meter doesn’t begin the Calculating
Animation (1,2,3 Countdown) and no test result is displayed.

[1] CAUSE: Defective test strip.

ACTION: Repeat the test with a new BGStar Test Strip. If this
does not work, call Customer Service at 1-800-633-1610. The
phone number is also printed on your meter’s cap label.

74 75
 [2] Insert the USB connector end of the cable into the

17
CHAPTER

iBGStar Meter Battery and Charging power adapter’s USB port.

NOTE: The iBGStar Meter must be charged before use.

If your Meter display does not turn on by:

(1) Pressing the meter button or (2) plugging the meter

into your iPhone or iPod touch, the meter must be charged by
connecting it to the power adapter or a computer. [3] Plug the power adapter into a wall outlet (100-240v,
50-60 Hz). The battery status and charging battery symbol
Charge your meter until the low battery symbol appears. will appear on the meter display.
When the symbol appears, you can unplug the meter and
begin testing.

Example of a Low Battery with charging symbol:

You cannot perform a test while a cable is plugged into the

micro-USB port and the meter’s battery is charging. NOTE: The iBGStar Meter should be charged frequently. It is
recommended to charge the device whenever the display
shows less than a 50% charge. This will ensure the longest
How to charge the iBGStar Meter using the power adapter: possible life. The iBGStar must be recharged at least every
6 months to maintain device functionality.
iBGStar Meter Battery and Charging

iBGStar Meter Battery and Charging

[1] Insert the micro-USB connector end of the cable into
the iBGStar Meter’s micro-USB port. When the iBGStar Meter is connected to the power adapter or
computer, the Battery image will appear.

The iBGStar Meter will take 3-5 hours to fully charge. Your
iBGStar is fully charged once the display shows the full
battery symbol.

76 77
 Example of 100% full battery power: into your laptop. The meter will not charge while the PC is off.
The battery status and charging battery symbol will appear
on the meter display.

Connect your iPhone or iPod touch to your meter to charge You can check your battery status in a number of ways:
both devices at the same time. 1. If the battery is 50% or less charged, press the meter’s
button or insert a new test strip to see how much
You cannot perform a test while a cable is plugged into the charge is left.
micro-USB port and the meter’s battery is charging. 2. Attach your meter to your iPhone or iPod touch with
the App open. This will only show you the battery
symbol, not the percent of batttery that is left. Close
How to charge the iBGStar Meter using the iPhone or iPod the app, deactivate the iPhone or iPod touch, then
touch: press the meter’s button to see the percent battery left.
3. Plug in your meter to the USB charging cable. After two
[1] Connect your meter to the iPhone or iPod touch. minutes, the meter will deactivate. Press the meter’s
button to see the percent battery left.
[2] Turn your iPhone or iPod touch on. The meter will not
charge while the iPhone or iPod touch is hibernating. The You can sync your iPhone or iPod touch to iTunes (on your PC)
battery status and charging battery symbol will appear on the via the micro-USB to USB Cable, while connected to your meter.
meter display for 5 seconds.

The meter will continue to charge using power from your

iPhone or iPod touch as long the iPhone or iPod touch is not
hibernating.
iBGStar Meter Battery and Charging

iBGStar Meter Battery and Charging

How to charge the iBGStar Meter by connecting to your PC:

[1] Insert the micro-USB connector end of the cable into

the iBGStar Meter’s micro-USB port.

[2] Ensure that your PC is on and insert the USB connector

end of the cable into the PC’s USB port. Ensure that the USB
port you plug in to is part of your computer’s CPU or directly
78 79
 18 19
CHAPTER

CHAPTER
Caring for Your iBGStar Meter
iBGStar Meter Specifications
and Lancing Device

When using your meter, avoid getting dirt, dust, blood, Assay Method: Dynamic Electrochemistry
control solution, water, or any other liquid into the test
strip port, micro-USB port or onto dock connector. Clean Maximum Altitude: 10,000 ft.
the outside of the meter or the lancing device using a cloth
dampened with mild detergent or mild soap. If you wish to Calibration: Plasma equivalent
clean the lancing device cap only, remove the cap; wash it in
warm water, rinse well, and dry. Coding: No Code

CAUTION: Never immerse the meter or the body of the Control Solution Storage Temperature: 36°F to 86°F (2°C
lancing device in water or any other liquid solution. to 30°C)

Sample: Whole blood, capillary

Blood Sample Size: 0.5 microliters

Average Glucose Test Time: 5 seconds

Measurement Units: mg/dL

Caring for Your iBGStar Meter and Lancing Device

Result Range: 20 to 600 mg/dL

Hematocrit: 20% to 60%

Operating Relative Humidity: 25% to 90%

iBGStar Meter Specifications

Operating Temperature: 50°F to 104°F (10°C to 40°C)

Memory: 300 blood glucose and control solution test results

with date, time

80 81
 Power Source: Lithium Rechargeable Polymer Battery

20

CHAPTER
Warranty
Automatic Shutoff: 1 minute after last user action

Size: Width 0.94” x Length 2.17” x Height 0.39” Warranty Terms

(24 mm x 55 mm x 10 mm)
Sanofi-aventis U.S. offers customers who buy (“You” or “Your”)
Test Strip Storage Temperature: 46°F to 86°F (8°C to 30°C) a new iBGStar Blood Glucose Meter (defined as “Meter”)
within the United States the following purchase protections.
Weight: 9.0 g Sanofi-aventis U.S. extends a limited lifetime warranty to
consumers who buy a new Meter. Under this limited warranty,
Equipment not suitable for use in the presence of flammable Your new Meter is covered for the period of ownership as
mixtures. long as it has not been modified, altered, or misused. Under
this warranty sanofi-aventis U.S. will replace, free of charge,
This iBGStar Blood Glucose Meter complies with the applicable Your Meter if it is defective in material or workmanship. If
standards for Electromagnetic Compatibility; however it is You wish to return Your Meter, call 1-800-633-1610. No other
not recommended that it be used in the presence of strong warranties, express or implied, are made. Sanofi-aventis U.S.
electromagnetic fields. When using the iBGStar meter, keep will not be liable for any incidental or consequential damages,
away from sources of electromagnetic disturbances such as so the above limitations or exclusions may not apply to You.
electric motors or radio transmitting equipment. The meter This Warranty gives You specific legal rights, and You may also
should not affect the normal operation of other devices. If have other rights that vary from state to state. Sanofi-aventis
this does occur, provide more distance between the meter U.S. may discontinue this program at any time without notice.
and the affected device. Your meter is an electronic device.
When disposing of your meter follow all local environmental
regulations.
iBGStar Meter Specifications

Warranty
82 83
 Please refer to the tables included later in this section for

21
CHAPTER

Electromagnetic Compatibility (EMC) more information regarding electromagnetic compatibility.

Medical electrical equipment needs special precautions

Warning! This device has been tested and found to regarding EMC and needs to be installed and put into
be in compliance with FCC Part 15, Subpart B. These service according to the EMC information provided in the
radio frequency limits are designed to provide accompanying documents.
reasonable protection against harmful interference
when the equipment is operated in a commercial Portable and mobile RF communications equipment can
environment. Like all similar equipment, this affect medical electrical equipment.
product generates, uses, and can radiate radio
frequency energy, which, if not installed and used Immunity to EN60601-1-2
in accordance with the Owner’s Guide, may cause • EN 61000-4-2: Electrostatic Discharge (ESD)
interference to other equipment. If in doubt about • EN 61000-4-3: Radiated Immunity
possible interference to other equipment, please • EN 61000-4-4: Electric Fast Transients (EFT)
contact your distributor for Customer Service. • EN 61000-4-5: High Voltage (HV) Surges
• EN 61000-4-6: Conducted RF
The iBGSTAR System was tested by an independent, • EN 61000-4-8: Power Frequency Magnetic Fields
accredited testing laboratory and found to meet the • EN 61000-4-11: Voltage Interruption
requirements of the test standards listed below. The iBGSTAR
system is EMC compliant with the iPhone/iPod accessories. Emissions to EN60601-1-2
• CISPR11 Class A Radiated Emissions
Warning! Use of accessories, transducers and cables other • CISPR11 Class A Conducted Emissions
than those specified, with the exception of transducers and
cables sold by the manufacturer of the iBGSTAR system as
replacement parts for internal components, may result in
Electromagnetic Compatibility (EMC)

Electromagnetic Compatibility (EMC)

increased emissions or decreased immunity of the iBGSTAR
system.

Warning! The iBGSTAR system should not be used adjacent

to or stacked with other equipment and that if adjacent
or stacked use is necessary, the iBGSTAR system should be
observed to verify normal operation in the configuration in
which it will be used.
84 85
 This device has been tested and found to be in compliance Guidance and manufacturer’s declaration – electromagnetic immunity
with FCC Part 15, Subpart B. These limits are designed to
The Model iBGSTAR Image Intensifier is intended for use in the electromagnetic
provide reasonable protection against harmful interference environment specified below. The customer or the user of the Model iBGSTAR Image
when the equipment is operated in a commercial Intensifier should assure that it is used in such an environment.
environment. This product generates, uses, and can radiate IMMUNITY IEC 60601 test Compliance Electromagnetic
radio frequency energy, which may cause interference to test level level environment – guidance

other equipment. If in doubt about possible interference to Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood,
discharge ± 8 kV air ± 8 kV air concrete or ceramic tile. If floors
other equipment, please contact your distributor for support. (ESD) are covered with synthetic
IEC 61000-4-2 material, the relative humidity
should be at least 30 %.
Guidance and manufacturer’s declaration – electromagnetic emissions
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality
The Model iBGSTAR is intended for use in the electromagnetic environment specified transient/ supply lines supply lines should be that of a typical
below. The customer or the user of the Model iBGSTAR should assure that it is used in burst ± 1 kV for input/ ± 1 kV for input/ commercial or hospital
such an environment. IEC 61000-4-4 output lines output lines environment.

Emissions test Compliance Electromagnetic environment – guidance Surge ± 1 kV line(s) to ± 1 kV Mains power quality
IEC 61000-4-5 line(s) differential mode should be that of a typical
RF emissions Group 1 The Model iBGSTAR uses RF energy only ± 2 kV line(s) to ± 2 kV common commercial or hospital
CISPR 11 for its internal function. Therefore, its RF earth mode environment.
emissions are very low and are not likely to
cause any interference in nearby electronic IEC 61000-4-11 <5 % U T 5 % UT Mains power quality should
Voltage (>95 % dip in U T) (>95 % dip in U T) be that of a typical commercial
equipment.
dips, short for 0,5 cycle for 0,5 cycle or hospital environment. If
RF emissions Class B The Model iBGSTAR is suitable for use in interruptions 40 % U T 40 % U T the user of the Model iBGSTAR
and voltage (60 % dip in U T) (60 % dip in U T) image intensifier requires
CISPR 11 all establishments, including domestic variations on for 5 cycles for 5 cycles continued operation during
establishments and those directly power supply 70 % U T 70 % U T power mains interruptions,
Harmonic emissions Class A connected to the public low-voltage power input lines (30 % dip in U T) (30 % dip in U T) it is recommended that
IEC 61000-3-2 supply network that supplies buildings used for 25 cycles for 25 cycles the Model iBGSTAR Image
for domestic purposes. <5 % U T <5 % U T Intensifier be powered from an
Voltage fluctuations/ Complies
(>95 % dip in U T) (>95 % dip in U T) uninterruptible power supply
flicker emissions for 5 s for 5 s or a battery.
IEC 61000-3-3
Power 3 A/m 3 A/m If image distortion occurs, it
Electromagnetic Compatibility (EMC)

Electromagnetic Compatibility (EMC)

frequency may be necessary to position
(50/60 Hz) the Model iBGSTAR image
magnetic field intensifier further from sources
IEC 61000-4-8 of power frequency magnetic
fields or to install magnetic
shielding. The power frequency
magnetic field should be
measured in the intended
installation location to assure
that it is sufficiently low.

NOTE U T is the a.c. mains voltage prior to application of the test level.

86 87
 Guidance and manufacturer’s declaration – electromagnetic immunity 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
The Model iBGSTAR is intended for use in the electromagnetic environment specified affected by absorption and reflection from structures, objects and people.
below. The customer or the user of the Model iBGSTAR should assure that it is used in
such an environment. a 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
IMMUNITY IEC 60601 TEST Compliance Electromagnetic environment
test LEVEL level – guidance broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
Conducted RF 3 Vrms Portable and mobile RF considered. If the measured field strength in the location in which the Model iBGSTAR is used
IEC 61000-4-6 150 kHz to 80 MHz 3 Vrms communications equipment should exceeds the applicable RF compliance level above, the Model iBGSTAR should be observed
be used no closer to any part of to verify normal operation. If abnormal performance is observed, additional measures may
Radiated RF 3 V/m 3 V/m the Model IBGSTAR, including be necessary, such as re-orienting or relocating the Model iBGSTAR.
IEC 61000-4-3 80 MHz to 2,5 GHz cables, than the recommended b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation
distance Recommended separation distances between portable and mobile RF
communications equipment and the Model iBGSTAR
The Model iBGSTAR is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Model iBGSTAR
can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
80 MHz to 800 MHz Model iBGSTAR as recommended below, according to the maximum output power of
the communications equipment.

800 MHz to 2,5 GHz Rated maximum Separation distance according to frequency of transmitter
where P is the maximum output output power m
power rating of the transmitter of transmitter
in watts (W) according to the W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter manufacturer and d
is the recommended separation
distance in metres (m).
Field strengths from fixed RF 0,01 0,12 0,12 0,23
transmitters, as determined by an
electromagnetic site survey,a should 0,1 0,38 0,38 0,73
be less than the compliance level in
each frequency range.b 1 1,2 1,2 2,3
Electromagnetic Compatibility (EMC)

Electromagnetic Compatibility (EMC)

Interference may occur in the vicinity
of equipment marked with the 10 3,8 3,8 7,3
following symbol:
100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in metres (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.

88 89
90 US.BGM.14.04.001 November 2013