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AgaMatrix iBGStar, Owner'S Manual

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AgaMatrix iBGStar Owner'S Manual Download Page 1

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 

Summary of Contents for iBGStar

Page 1: ...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 ...

Page 2: ...e 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 n...

Page 3: ...rmation 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 Warrant...

Page 4: ...ch with at least 30 MB of available space 3 Check www ibgstar comwww ibgstar com to see which iPhone and iPod touch and which versions of the Apple Operating Systems iOS versions are supported 3 Made for iPhone 3G 3GS 4 and 4S iPod touch 2nd 3rd and 4th generation 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...

Page 5: ...n 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 ...

Page 6: ...nformation 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 ...

Page 7: ...le 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 Bu...

Page 8: ...t 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...

Page 9: ...pdate 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 ...

Page 10: ...iabetes 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 ...

Page 11: ...tes 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 iB...

Page 12: ...tment 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 4 Please read the following 1 Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur fo...

Page 13: ...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 ...

Page 14: ...te 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...

Page 15: ...res 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...

Page 16: ...ecting 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 d...

Page 17: ...perly 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 ...

Page 18: ...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...

Page 19: ...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...

Page 20: ...st 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 fill 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 ...

Page 21: ...n test results are out of the range repeat the testand refer to Chapter 8 of this guide to see potential causes of error If the results from the control solution tests continue to fall outside that range do not use the iBGStar Blood Glucose Monitoring System to test your blood glucose Call Customer Service at 1 800 633 1610 The phone number is also printed on your iBGStar meter s cap label 7 Remov...

Page 22: ...r 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 1 Do not sync the app on your iPhone or iPod touch with an 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 c...

Page 23: ...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 8 Carefully read the test results on the meter screen before making any treatment decisions Important Information About Testing Your Blood Glucose Level Important Information About Testing Your Blood Glucose Level WARNING The lanci...

Page 24: ...ot 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 How to Test Your Blood Glucose Level Example Results...

Page 25: ...ent scorecard With iPhone or iPod touch Without iPhone or iPod touch How to Test Your Blood Glucose Level 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...

Page 26: ... is charging with the cable 4 Meter Ready For Test The meter now displays the Apply Sample to Test Strip Animation 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 blood You do not need to set a calibration code for the me...

Page 27: ...bol will appear on the meter s screen and your iPhone or iPod touch will beep when you should remove the test strip from the blood sample It will only beep when sound is enabled and your meter is connected to your iPhone or iPod touch the app is launched 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 in...

Page 28: ...eter 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 Example Result Refer to the iBGStar Diabetes Manager Application User s Guide for more information on mealtime tags and the Meal Schedule settings Any test performed when using the Meter independently will not be assigned...

Page 29: ...d lancet Extract the lancet from the lancet holder cup by pulling on the plastic collar of the lancet near the middle of the lancet How to Test Your Blood Glucose Level Replace the lancing device cap onto the lancing device until it snaps or clicks into place Discard the used BGStar Test Strip and lancet properly Follow your healthcare providers instructions for disposal Wash your hands thoroughly...

Page 30: ...est 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 removing the lancing device and the concave tip aids in the collection of a blood sample Obtaining a Blood Sample From Alternative Sites Palm or Forearm...

Page 31: ...tton Obtaining a Blood Sample From Alternative Sites Palm or Forearm Palm Forearm Palm Forearm Obtaining a Blood Sample From Alternative Sites Palm or Forearm 4 Obtain a Drop of Blood After lancing hold the lancing device against your skin until a blood droplet forms Do not squeeze directly around the lanced area Make sure the blood drop is large enough to completely fill the visual fill window of...

Page 32: ...ector ie iPhone 5 or iPod touch 5 an adapter is necessary to sync your iBGStar meter with the app The Apple Lightning Adapter or Apple Lightning Cable Adapter 0 2m are the recommended adapters for syncing your iBGStar Meter to the app 1 Insert the Lightning Adapter into the iPhone or iPod touch Lightning Connector 2 Insert the iBGStar meter into the Lightning Adapter already attached to the iPhone...

Page 33: ...the time and date on your meter whenever it syncs Syncing Syncing 13 CHAPTER Syncing During every sync 3Any new data with a time and date will be downloaded from the meter to the app 3The meter is configured to match the iPhone or iPod touch s time and date 3The meter s battery will charge All test result scorecards in the iBGStar Application with data that has been downloaded from the iBGStar met...

Page 34: ...l to the right of the test result Example Results Viewing Past Test Results on the iBGStar Meter Viewing Past Test Results on the iBGStar Meter 14 CHAPTER Viewing Past Test Results on the iBGStar Meter If it was a control solution test result the control solution icon will appear to the right of the test result In this case a symbol will not appear to the right of the result 2 Viewing all stored t...

Page 35: ...s occurring when no test strip is inserted are displayed for 5 seconds and then the meter will deactivate unless a new test strip is inserted CAUTION Low or high blood glucose test results can indicate a potentially serious medical condition Follow your healthcare professional s recommendations These results represent meter operating range Consult your healthcare professional for appropriate targe...

Page 36: ...th an ambient temperature of 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 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 ACTIONS Move to an area with an ...

Page 37: ...ult your healthcare professional Error Messages and Troubleshooting Error Messages and Troubleshooting 16 CHAPTER Error 1 Problems have occurred that are 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 2 If the message appears during a test the test strip may have been removed too early Ret...

Page 38: ...y be caused by a non blood sample or a combination of high glucose and other medical conditions 2 If this error code persists on retesting consult your healthcare professional Error Messages and Troubleshooting Error Messages and Troubleshooting Error 6 The test strip has taken too long to generate a signal 1 This may be caused by a combination of cold operating temperature and high hematocrit lev...

Page 39: ...er 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 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 th...

Page 40: ...or end of the cable into the iBGStar Meter s micro USB port iBGStar Meter Battery and Charging 17 CHAPTER iBGStar Meter Battery and Charging 2 Insert the USB connector end of the cable into the power adapter s USB port 3 Plug the power adapter into a wall outlet 100 240v 50 60 Hz The battery status and charging battery symbol will appear on the meter display NOTE The iBGStar Meter should be charge...

Page 41: ...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 iBGStar Meter Battery and Charging 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 You can check your battery status in a num...

Page 42: ...cing device in water or any other liquid solution Caring for Your iBGStar Meter and Lancing Device 18 CHAPTER Assay Method Dynamic Electrochemistry Maximum Altitude 10 000 ft Calibration Plasma equivalent Coding No Code Control Solution Storage Temperature 36 F to 86 F 2 C to 30 C Sample Whole blood capillary Blood Sample Size 0 5 microliters Average Glucose Test Time 5 seconds Measurement Units m...

Page 43: ...ce When disposing of your meter follow all local environmental regulations Warranty Terms Sanofi aventis U S offers customers who buy You or Your a new iBGStar Blood Glucose Meter defined as Meter within the United States the following purchase protections Sanofi aventis U S extends a limited lifetime warranty to consumers who buy a new Meter Under this limited warranty Your new Meter is covered f...

Page 44: ...may result in 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 Electromagnetic Compatibility EMC 21 CHAPTER Electromagnetic Compatibili...

Page 45: ...n environment IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floorsshouldbewood concreteorceramictile Iffloors arecoveredwithsynthetic material therelativehumidity shouldbeatleast30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input o...

Page 46: ...xed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Model iBGSTAR is used exceeds the applicable RF compliance level above the Model iBGSTAR should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Model iBGSTAR b Over ...

Page 47: ...90 US BGM 14 04 001 November 2013 ...

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