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Blood Glucose Monitoring System

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1. 36 37 If your meter is connected to your iPhone or iPod touch and the app is launched the app will play an animation of a sample being applied to a test strip The IBGStar Blood Glucose Monitoring System is now ready for you to apply control solution You do not need to set a calibration code for the meter Note If you connect your meter to your iPhone or iPod touch and insert a test strip into the meter before launching the app the app will not play an animation of a sample being applied to a test strip If you do not start the test within 4 minutes of inserting a test strip the meter will display the battery status and charging symbol To continue testing take out the unused BGStar Test Strip Reinsert the test strip into the meter Avoid touching the test strip s sample area where control solution should be applied 4 Applying Control Solution Shake the control solution bottle Discard the first drop of control solution Wipe the bottle tip clean using a clean tissue or paper towel Dispense a second drop onto a clean surface such as an unused resealable plastic bag Bring the tip of the test strip to the control solution sample The iBGStar Blood Glucose Monitoring System will automatically detect if a test is performed with BGStar Control Solution How to Perform a Control Solution Test This is the visual fi ll window Do not put Control Solution here APPLY CONTROL SOLUTION HERE
2. 4 After 2 minutes of contact time let air dry You should wash your hands thoroughly with soap and water after handling the meter lancing device and BGStar Test Strips If you have any questions about cleaning and disinfecting your iBGStar meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m or lancing device call Customer Service at 1 800 633 1610 Important Disinfection Procedures Important Disinfection Procedures 30 31 Important Information About Performing Control Solution Tests 7 CHAPTER The iBGStar Blood Glucose Monitoring System can be used with BGStar Control Solution control solution Control solution should only be used for 90 days after first opening the bottle or until the expiration date printed on the label whichever comes first IMPORTANT Count forward 90 days from the date you open a new bottle of BGStar control solution This is your discard date Write the discard date on the BGStar control solution bottle CAUTION Results from control solution tests do not refl ect your blood glucose level The control solution range is a target range for control solution only It is not a target range for your blood glucose level The control solution is used to 1 Ensure that your iBGStar Meter and BGStar Test Strips test strips are working together properly 2 Practice testing without having to use your own blood Important Information A
3. Critically ill patients should not be tested with blood glucose meters 2 Severe dehydration and excessive water loss may yield inaccurate results If you believe you are suffering from severe dehydration consult your healthcare professional immediately 3 Patients undergoing oxygen therapy may receive inaccurate results 4 Results below 70 mg dL may mean low blood glucose levels hypoglycemia 5 Results over 240 mg dL may mean high blood glucose levels hyperglycemia Checking ketones may be advisable 6 If you get results below 70 mg dL or above 240 mg dL and do not have symptoms of hypoglycemia or hyperglycemia repeat the test If you have symptoms or continue to get results that fall below 70 mg dL or rise above 240 mg dL follow the treatment plan recommended by your healthcare team or contact your healthcare professional immediately 7 If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this iBGStar Blood Glucose Monitoring System Owner s Guide follow your healthcare professional s recommendations CHAPTER Important Health related Information 22 23 Important Information About Your iBGStar Blood Glucose Monitoring System 5 CHAPTER The iBGStar Blood Glucose Monitoring System the meter should be used 1 For measuring blood glucose levels from fresh capillary whole blood samples taken from the fingertip
4. 5 years What can you use to clean and disinfect your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device See the table below for the suggested disinfecting wipe You should use wipes that are pre saturated with disinfectant Do not immerse your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter Apple Lightning to 30 pin Adapter 0 2m or body of the lancing device in any liquid solution If you suspect your meter is not working properly after disinfecting verify that your system is working properly by performing a control solution test If your control solution test result falls out of control range call Customer Service at 1 800 633 1610 If you should notice any signs of deterioration on the meter lancing device Apple Lightning to 30 pin Adapter Apple Lightning to 30 pin Adapter 0 2m or iPhone iPod touch such as clouding on the meter or iPhone iPod touch display corrosion or erosion of meter adapters and lancing device plastic housing or outer components of iPhone iPod touch or cracking of plastic housing display or button or if the meter or iPhone iPod touch does not turn on or if the lancing device or adapters do not work after cleaning and disinfection discontinue use of the system and contact Customer Service at 1 800 633 1610 Availability of disinfecting wipe may vary For updated information you may call Customer Service at 1 800
5. 633 1610 Important Disinfection Procedures 28 29 EPA Brand Name Manufacturer Available at Contact Time 9480 4 Super Sani Professional Online 2 Minutes Cloth Disposables Amazon com Germicidal International Officedepot com Disposable Inc PDI Wipe Active ingredient Quaternary ammonium chlorides and isopropanol How do you clean and disinfect your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device 1 Before you clean and disinfect your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device pre clean the outside with a disinfecting wipe 2 With a new disinfecting wipe disinfect your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device using the disinfecting wipe listed in the table above and follow the instructions below In addition follow the instructions on the disinfecting wipe container label for safe handling of the wipes 3 Wipe each side of your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device with moderate pressure 3 times using the following method a Wipe up and down 3 times b Wipe left and right 3 times c Avoid getting disinfectant inside the test strip port the micro USB port and the dock connector
6. Adjustment Dial Adjusts how deep the lancet will lance the skin 3 Depth Indicator Window Displays the depth setting of the lancing device 4 Release Button Fires the lancet 5 Lancet Holder Cup Holds the lancet into place inside the lancing device 6 Lancing Device Cap Covers the lancet when in lancing device 7 Alternative Site Testing Cap Used for obtaining a blood sample on the palm at the base of the thumb or forearm 8 Lancet Lances the skin to produce a drop of blood 9 Lancet Cover Covers the lancet for safety Remove after inserting into the lancet holder cup 7 1 2 3 4 5 9 6 8 About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System Example Results 12 13 11 Battery Status Shows the amount of power in the iBGStar s battery 12 Charging Battery Symbol Appears to the left of the Battery Status symbol when the meter s battery is being charged Example of 60 Battery Power Remaining 7 Sample Applied Symbol During testing this symbol will appear when you should remove the test strip from the sample 8 Calculating Animation 1 2 3 countdown During testing an animated sequence of bars and 1 2 3 will appear on the meter display This is after a sample has been applied to the test strip This means the meter is calculating the test result 9 iBGStar Animation An animation of the iB
7. Test Strips beyond the expiration date or 180 days after first opening the vial This may cause inaccurate results Write the discard date 180 days from the first opening on the test strip vial 8 Do not bend cut or alter BGStar Blood Glucose Test Strips 1 2 3 4 5 About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System 10 11 About the iBGStar Meter Display and Symbols 1 Glucose Test Result 2 Units of Measurement scrolls across display Results will be displayed in mg dL 3 Time scrolls across display Syncing will configure the time format to match your iPhone or iPod touch s settings The format is in either 12 or 24 Hour 4 Date scrolls across display Syncing will configure the date format to match your iPhone or iPod touch s settings The format is in either MM DD YY or DD MM YY 5 Control Solution Symbol Appears to the right of control solution test results 6 Apply Sample to Test Strip Animation During testing an animation of a sample being applied to the test strip will appear on the meter display This means you may apply a sample to the test strip A sample may either be control solution or blood About the iBGStar Lancing System Note Lancing Devices and Lancets are only intended for a single user and should not be shared between users 1 Cocking Handle Cocks the device so it is ready to lance 2 Depth
8. and 4S iPod touch 2nd 3rd and 4th generation For use with iPhone 5 or iPod touch 5th generation an Apple Lightning to 30 pin Adapter not included in package is required iOS 4 5 or 6 The iBGStar Diabetes Manager App installed on that iPhone or iPod touch The iPhone and iPod touch are sold separately The iBGStar Diabetes Manager Application is not included with the iBGStar Blood Glucose Monitoring System It can be downloaded from the App Store on your iPhone or iPod touch To install the app follow instructions in Chapter 3 Getting Started Getting Started iBGStar Blood Glucose Meter Dock Connector Cover Lancing Device with Cap Works with most generic lancets such as BD Ultra Fine 33 Gauge Lancets Power Adapter Sterile Lancets Clear AST Lancing Device Cap Micro USB to USB Cable 1 Vial of 10 Test Strips Control Solution x10 6 7 About the BGStar Blood Glucose Test Strip 1 Front of the Test Strip The front of the test strip is black in color Ensure that the front black colored side of the test strip is facing towards you when inserting a test strip into the meter s test strip port 2 Back of the Test Strip The back of the test strip is white in color Ensure that the back white colored side of the test strip is facing away from you when inserting a test strip into the meter s test strip port 3 Contact Bars This end is inserted front of the test strip facing t
9. app s homescreen will be displayed How to Perform a Control Solution Test Example Results 34 35 Connect your meter to your iPhone or iPod touch by inserting the meter s dock connector into the iPhone or iPod touch s dock connector port The dock connector port is located below the home button of either device Your meter and the app will sync upon connection The battery status and charging battery symbol will appear on your meter s display If your iBGStar meter is already connected to your iPhone or iPod touch then launch the iBGStar Diabetes Manager Application to begin syncing between your meter and the app Note Attaching iBGStar to an iPhone or iPod touch in the sleep off mode will not turn the iPhone on The iBGStar screen will activate and the charging icon will appear How to Perform a Control Solution Test Example Results 2 Inserting a BGStar Test Strip Insert a new BGStar Test Strip into the meter s test strip port Make sure you insert the test strip with the contact bars facing towards you into the test strip port The meter will be activated You cannot perform a test while a cable is plugged into the micro USB port and the meter s battery is charging 3 iBGStar Meter Ready For Test The meter now displays the Apply Sample to Test Strip Animation How to Perform a Control Solution Test With iPhone or iPod touch Without iPhone or iPod touch Apply Sample to Test Strip Animation
10. area Make sure the blood drop is large enough to completely fill the visual fill window of the test strip Pull the lancing device directly off your palm or forearm to ensure that you do not smear the blood drop Return to Chapter 10 step 6 to continue with testing instructions Palm Forearm 60 61 Before syncing for the first time the iBGStar Diabetes Manager Application must be installed on your iPhone or iPod touch For instructions on installing the app refer to Chapter 3 Ensure that the time and date is properly set on your iPhone or iPod touch before syncing your meter to the app For instructions on how to set the time and date on your iPhone or iPod touch refer to the support materials for each device Tap the iBGStar Diabetes Manager Application icon on your iPhone or iPod touch to launch the app Connect your meter to your iPhone or iPod touch by inserting the iBGStar 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 Example Result Syncing for the First Time Syncing for the First Time CHAPTER 12 Syncing for the First Time If your meter is already connected to the iPhone or iPod touch 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 app The Apple Lightning Adapter or A
11. closed removing the used test strip will make your meter display the battery status and charging symbol All test result scorecards in the app that have been downloaded from the iBGStar meter will have a Lock 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 How to Perform a Control Solution Test Example Results 40 41 To disconnect your meter from the iPhone or iPod touch hold your iPhone or iPod touch firmly with one hand and use your other hand to pull your meter away from the iPhone or iPod touch Your meter will deactivate 8 Dispose of Used Materials Properly Follow your healthcare provider s instructions for disposal How to Perform a Control Solution Test Example Results Important Information About Testing Your Blood Glucose Level 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 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 syn
12. display 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 possible life The iBGStar must be recharged at least every 6 months to maintain device functionality 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 78 79 iBGStar Meter Battery and Charging Example of 100 full battery power Connect your iPhone or iPod touch to your meter to charge both devices at the same time You cannot perform a test while a cable is plugged into the micro USB port and the meter s battery is charging How to charge the iBGStar Meter using the iPhone or iPod touch 1 Connect your meter to the iPhone or iPod touch 2 Turn your iPhone or iPod touch on The meter will not charge while the iPhone or iPod touch is hibernating The battery status and charging battery symbol will appear on the 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 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 an
13. display the Apply Sample to Test Strip Animation after inserting a BGStar Test Strip 1 CAUSE The meter s battery has insufficient power ACTION The meter s battery must be charged immediately For details about charging your meter refer to Chapter 18 2 CAUSE The BGStar Test Strip has been inserted upside down wrong end in or incompletely inserted into the meter 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 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 Error Messages and Troubleshooting Error Messages and Troubleshooting 2 CAU
14. is removed or when the meter automatically deactivates Error messages 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 In certain cases the meter may return an error code or provide an inaccurate result if it is being used near electrical equipment like a power generator or a computer monitor CAUTION If you get repeated error messages and are experiencing symptoms of hypo or hyperglycemia contact your healthcare professional immediately as this may indicate low or high glucose If this error code persists on retesting consult your healthcare professional 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 Retest using a new test strip 3 If this message appears after the last progress bar instead of a result it may indicate that you applied more blood after testing began Retest using a new test strip Error 2 The iBGStar meter has detected an irregularity with the sample 1 The test strip may be partially filled You should check the window of the test strip to confirm that it is full Retest u
15. pinhead to perform a glucose test For the best results test glucose from the tips of any finger The palm at the base of the thumb and forearm are alternative but less accurate test sites Only select soft and fleshy areas to lance Avoid lancing any bony areas obvious veins or moles Physiological differences in circulation between the fingertip palm at the base of the thumb and forearm may result in differences in blood glucose measurements between these sites Differences in glucose concentrations may be observed after eating taking insulin or exercise Changes in blood glucose may be detected in the fingertips before the palm at the base of the thumb and forearm Important Information About Your iBGStar Blood Glucose Monitoring System 26 27 Important Disinfection Procedures 6 CHAPTER When using your iBGStar avoid getting dirt dust blood control solution water or any other liquid into the test strip port micro USB port or onto the dock connector You should wash your hands thoroughly after handling the meter lancing device or test strips Your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device should be disinfected periodically Cleaning and Disinfecting will kill the bacteria and viruses that you cannot see Cleaning and disinfecting your iBGStar meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightnin
16. 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 CAUTION To ensure accurate results wash your hands with warm soapy water and dry before every test Clean and make sure there is no grease oil or lotion on the test site Follow Chapter 9 steps 1 4 to begin blood glucose testing 1 Prepare the Lancing Device Replace the gray lancing device cap with the clear cap Obtaining a Blood Sample From Alternative Sites Palm or Forearm 58 59 2 Rub Test Site To increase the blood flow in your palm at the base of the thumb or forearm rub the area that you will be testing Ensure that your palm or forearm is facing up and held level 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 the test site for a few seconds Then press the release button 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
17. 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 LOW BATTERY MESSAGE This message appears for 2 seconds MEANING The battery in your meter is low on power ACTIONS If the battery symbol appears the battery in your meter must be charged For details about charging your meter refer to Chapter 17 DEAD BATTERY MESSAGE MEANING The battery in your meter does not have enough power to activate your meter and perform a test ACTIONS If the dead battery symbol appears the battery in your meter must be charged For details about charging your meter refer to Chapter 17 70 71 The iBGStar Blood Glucose Monitoring System has been designed to work accurately under most usual conditions On rare occasions the meter will display an error message instead of a glucose result In addition if the meter is connected to an iPhone or iPod touch and the iBGStar Application is launched the app will display the error message The iBGStar Blood Glucose Monitoring System is able to detect specific problems which may allow you to determine the cause of the error without wasting valuable test strips When you are presented with an error message check for possible problems related to each message listed in this chapter Error messages occurring while a test strip is inserted are displayed until the test strip
18. 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 a mealtime tag when it is synced with the app Test result scorecards containing data downloaded from the iBGStar meter will have a Lock icon in the upper left corner in place of the Delete icon The Lock icon indicates that the blood glucose value and associated time and date cannot be deleted or edited Carbs Insulin Tag 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 To disconnect the meter from the iPhone or iPod touch hold the iPhone or iPod touch firmly with one hand and use your other hand to pull the meter away from the iPhone or iPod touch Your meter will deactivate How to Test Your Blood Glucose Level Example Result 54 55 How to Test Your Blood Glucose Level 10 Final Steps Remove the Lancet When you have finished testing snap off the cap from the lancing device Be careful not to touch the lancet tip 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
19. 5 Remove Test Strip From Control Solution Sample When the Test Strip s Visual Fill Window Completely Turns Blue The sample applied symbol will appear on the iBGStar meter s screen Your iPhone or iPod touch will beep when you should remove the test strip from the control solution sample It will only beep if your meter is connected to your iPhone or iPod touch the app is launched and Sounds have been activated in the Settings menu of your iPhone or iPod touch and the device s volume level is audible The Calculating Animation a sequence of bars and 1 2 3 will begin on the meter display This animation means that a sample has been applied to the test strip and the meter is calculating the test result In addition if your meter is connected to your iPhone or iPod touch and app the app will display an animation showing that the meter is calculating the test result How to Perform a Control Solution Test 1 The entire visual fi ll window will turn blue Sample applied symbol 1 2 3 Calculating Animation 38 39 6 Viewing Control Solution Test Result The control solution test result will appear on the meter display The unit of measure mg dL time and date of testing will scroll to the right of the control solution test result The control solution symbol will appear next to the test result The control solution test result is stored in the meter s memory In addition if the meter is connected to an iPh
20. 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 1 Toll Free 24 Hour Customer Service 1 800 633 1610 In case of emergency contact your healthcare professional or emergency medical response Key Features iBGStar Diabetes Manager Application an iPhone and iPod touch application app designed for the iBGStar Meter The iBGStar Meter can easily download test results to the iBGStar Diabetes Manager Application via the dock connector on the iPhone or iPod touch The app can be used to conveniently store and manage your diabetes information review trends or share with your healthcare team It can be downloaded from the App StoreSM No Coding Required The iBGStar Meter doesn t require you to code the meter Insert a BGStar Test Strip and you are ready to test Blood Glucose Monitoring System By using the iBGStar Blood Glucose Monitoring System Meter with the iBGStar Diabetes Manager Application the app You agree that the use of this software together with an iPod iPhone or iPad Apple Product shall only be as a personal o
21. GStar logo will appear when the meter is activated This happens by pressing the meter button or inserting a test strip This will not show if you are connected to your iPhone or iPod touch with the app launched 10 Battery Status if 50 charged or less If the battery is 50 charged or less the Battery Status symbol appears at the end of the iBGStar animation for 1 second The percentage charged will be shown to the left of the Battery Status symbol Example of 100 Full Battery Power 1 2 3 Example of 50 Battery Power Remaining About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System 14 15 How to install the iBGStar Diabetes Manager Application using iTunes The iBGStar Diabetes Manager Application the app can be downloaded from the App Store The App Store can be accessed through iTunes or by tapping the App Store icon on your iPhone or iPod touch You must have internet access to download the app Downloading the app through your iPhone or iPod touch 1 Ensure that your iPhone or iPod touch is on and the home screen is showing 2 Launch the App Store application on your iPhone or iPod touch and enter iBGStar into the search box NOTE Accessing the App Store requires an internet connection For assistance with this visit http www apple com support 3 Tap the app icon 4 Tap the FREE button then INSTALL When prompted sig
22. Pod touch with the app launched You launch the app with your meter already connected to the iPhone or iPod touch Ensure that the time and date is properly set on your iPhone or iPod touch before syncing your meter to your iPhone or iPod touch For instructions on how to set the time and date on your iPhone or iPod touch refer to the support materials for each device The time and date from your iPhone or iPod touch will be used to set the time and date on your meter whenever it syncs Syncing Syncing 13 CHAPTER Syncing During every sync Any new data with a time and date will be downloaded from the meter to the app The meter is configured to match the iPhone or iPod touch s time and date The meter s battery will charge All test result scorecards in the iBGStar Application with data that has been downloaded from the iBGStar meter will have a Lock icon in the upper left corner in place of the Delete icon The Lock icon indicates that the test result value and associated time and date cannot be 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 Diabetes Manager Application User s Guide If you disconnect the meter from the iPhone or iPod touch during a sync all new data may not completely download and the meter s time and date may not match the iPhone or iPod touch s ti
23. SE Sample was applied after 4 minutes of inserting a test strip ACTION Repeat the test using a new BGStar Test Strip Wait until you see the Apply Sample to Test Strip Animation appear on the meter display screen before you apply the blood sample 3 CAUSE Defective meter ACTION Call Customer Service at 1 800 633 1610 The phone number is also printed on your meter s cap label 76 77 iBGStar Meter Battery and Charging 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 Charge your meter until the low battery symbol appears 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 How to charge the iBGStar Meter using the power adapter 1 Insert the micro USB connector 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
24. bout Performing Control Solution Tests Control solution tests should be performed when you 1 First get your meter 2 Suspect that your meter or test strips are not working properly 3 Think your test results are not accurate 4 Have dropped or damaged your meter or exposed your meter to liquids 5 Are advised by your healthcare professional to do so Important BGStar Control Solution information 1 Use only BGStar Control Solution with your iBGStar Blood Glucose Monitoring System 2 Always shake the control solution bottle before use 3 Always discard the first drop of control solution and wipe the bottle tip clean using a clean tissue or paper towel 4 Replace the cap on the control solution bottle immediately after use 5 Do not add water or any other liquid to control solution 6 Control solution tests should be performed within the system operating temperature range of 50 F to 104 F 10 C to 40 C Important Information About Performing Control Solution Tests 32 33 Out of range test results may be caused by 1 Expired or defective control solution 2 Expired or defective test strip 3 Error in performing test 4 Watered down control solution 5 Meter malfunction 6 Control solution test done outside the system operating temperature of 50 F to 104 F 10 C to 40 C 7 Failure to shake the control solution bottle vigorously before using 8 Failure
25. c with another person s meter the data from each meter will be combined in the app and may give you incorrect reports 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 which may give you incorrect reports 9 CHAPTER Important Information About Testing Your Blood Glucose Level 42 43 IMPORTANT 1 Remove the test strip from the blood sample as soon as the test strip s visual fill window completely turns red 2 Do not press the BGStar Test Strip against the test site 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 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 lancing device an
26. d 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 number of ways 1 If the battery is 50 or less charged press the meter s button or insert a new test strip to see how much charge is left 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 the app deactivate the iPhone or iPod touch then press the meter s button to see the percent battery left 3 Plug in your meter to the USB charging cable After two minutes the meter will deactivate Press the meter s button to see the percent battery left You can sync your iPhone or iPod touch to iTunes on your PC via the micro USB to USB Cable while connected to your meter 80 81 Caring for Your iBGStar Meter and Lancing Device When using your meter avoid getting dirt dust blood control solution water or any other liquid into the test strip port micro USB port or onto dock connector Clean the outside of the meter or the lancing device using a cloth dampened with mild detergent or mild soap If you wish to clean the lancing device cap only remov
27. d lancets should only be used by one person Never share lancing devices or lancets Used test strips lancets and lancing devices may be considered biohazardous or medical waste in your city or town Follow your healthcare provider s instructions for disposal 44 45 This chapter explains how to perform a test with the iBGStar Diabetes Manager Application To perform a blood glucose test using the iBGStar Meter independently Skip step 2 You must sync your meter to the app to be able to download readings from your meter to the app and set your meter s time and date For instructions on how to sync for the first time refer to Chapter 12 Test results without a set time and date Will be saved to the 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 meter with and in place of the time and date If have you synced your iBGStar meter to the app previously and you see dashes in place of the time and date you need to re sync your meter with the app Readings that do not have a time and date associated with them will not download to the app You can manually add these readings to the app to include them in your statistics For best results frequently sync the meter with your app 1 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 ba
28. d touch firmly with one hand and use your other hand to pull your meter away from the iPhone or iPod touch Your meter will deactivate Viewing Past Test Results on the iBGStar Meter Display Messages Messages occurring while a test strip is inserted are displayed until the test strip is removed or when the meter automatically deactivates Messages 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 target ranges LOW MESSAGE MEANING Glucose test result is lower than 20 mg dL This low 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 lt 20 mg dL with time and date The value will be represented as 20mg dL in the statistics in the app 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
29. d with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m Electromagnetic Compatibility EMC 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 affected by absorption and reflection from structures objects and people 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 broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed 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 the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 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 mai
30. e has been tested and found to be in compliance with FCC Part 15 Subpart B These radio frequency limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment Like all similar equipment this product generates uses and can radiate radio frequency energy which if not installed and used in accordance with the Owner s Guide may cause interference to other equipment If in doubt about possible interference to other equipment please contact your distributor for Customer Service The iBGSTAR System was tested by an independent accredited testing laboratory and found to meet the requirements of the test standards listed below The iBGSTAR system is EMC compliant with the iPhone iPod accessories Warning Use of accessories transducers and cables other 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 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 Compatibility EMC Please refer to the tables includ
31. e the cap wash it in warm water rinse well and dry CAUTION Never immerse the meter or the body of the lancing 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 mg dL Result Range 20 to 600 mg dL Hematocrit 20 to 60 Operating Relative Humidity 25 to 90 Operating Temperature 50 F to 104 F 10 C to 40 C Memory 300 blood glucose and control solution test results with date time iBGStar Meter Specifications iBGStar Meter Specifications 19 CHAPTER 82 83 iBGStar Meter Specifications Power Source Lithium Rechargeable Polymer Battery Automatic Shutoff 1 minute after last user action Size Width 0 94 x Length 2 17 x Height 0 39 24 mm x 55 mm x 10 mm Test Strip Storage Temperature 46 F to 86 F 8 C to 30 C Weight 9 0 g Equipment not suitable for use in the presence of flammable mixtures This iBGStar Blood Glucose Meter complies with the applicable standards for Electromagnetic Compatibility however it is not recommended that it be used in the presence of strong electromagnetic fields When usi
32. ed later in this section for more information regarding electromagnetic compatibility Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents Portable and mobile RF communications equipment can affect medical electrical equipment Immunity to EN60601 1 2 EN 61000 4 2 Electrostatic Discharge ESD EN 61000 4 3 Radiated Immunity EN 61000 4 4 Electric Fast Transients EFT EN 61000 4 5 High Voltage HV Surges EN 61000 4 6 Conducted RF EN 61000 4 8 Power Frequency Magnetic Fields EN 61000 4 11 Voltage Interruption Emissions to EN60601 1 2 CISPR11 Class A Radiated Emissions CISPR11 Class A Conducted Emissions Electromagnetic Compatibility EMC 86 87 This device has been tested and found to be in compliance with FCC Part 15 Subpart B These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment This product generates uses and can radiate radio frequency energy which may cause interference to other equipment If in doubt about possible interference to other equipment please contact your distributor for support Guidance and manufacturer s declaration electromagnetic emissions The Model iBGSTAR is intended for use in the electromagnetic environment specif
33. egistered in the U S and other countries App Store is a service mark of Apple Inc Content purchased from the iTunes Store is for personal lawful use only Don t steal music Made for iPod and Made for iPhone mean that an electronic accessory has been designed to connect specifically to iPod or iPhone respectively and has been certified by the developer to meet Apple performance standards Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards Please note that the use of this accessory with iPod or iPhone may affect wireless performance 2 3 Contents Getting Started About the iBGStar Blood Glucose Monitoring System How to Install and Update the iBGStar Diabetes Manager Application Important Health related Information Important Information About Your iBGStar Blood Glucose Monitoring System Important Disinfection Procedures Important Information About Performing Control Solution Tests How to Perform a Control Solution Test Important Information About Testing Your Blood Glucose Level How to Test Your Blood Glucose Level Obtaining a Blood Sample From Alternate Sites Palm or Forearm Syncing for the First Time Syncing Viewing Past Test Results on the iBGStar Meter Display Messages Error Messages and Troubleshooting iBGStar Meter Battery and Charging Caring for Your iBGStar Meter and Lancing Device iBGStar Meter Specification
34. essional immediately If this error code persists on 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 5 The meter was unable to produce a reliable result 1 This may 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 levels Retest in a warmer location 2 If this error code persists on retesting call Customer Service at 1 800 633 1610 The phone number is also printed on your meter s cap label Error 7 iBGStar meter problems have occurred that are beyond your control Call Customer Service for assistance at 1 800 633 1610 The phone number is also printed on your meter s cap label Error 8 A problem has occurred related to the meter hardware 1 This may be caused by connecting a power adapter to the meter while testing Disconnect the power adapter and retest 2 If this error code persists on retesting contact Customer Service at 1 800 633 1610 The phone number is also printed on your meter s cap label 74 75 Troubleshooting Situation 1 Meter does not
35. est results Press and release the meter button to view the next most recent test result The date time and mg dL unit of measure will scroll to the right of the test result Continue to press and release the meter button to view every test result starting from the most recent and ending with the oldest To return to the most recent test result deactivate your iBGStar meter by pressing and holding the meter button until the meter deactivates Then reactivate the meter by pressing and releasing the meter button once When you ve reached the oldest last test result saved press 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 Example Results Example Results 66 67 3 Deactivate your iBGStar meter When using your meter independently press and hold the meter button until the meter deactivates If the meter is left inactive for 1 minute it will automatically deactivate If you are viewing past results while the meter is connected to the iPhone or iPod touch with the app closed the meter will display the battery status and charging symbol after 1 minute of inactivity If the iPhone or iPod touch is hibernating when the device is on and the touch screen is locked or off the meter will deactivate To disconnect your meter from your iPhone or iPod touch hold the iPhone or iPo
36. g to 30 pin Adapter 0 2m and Lancing Device CAUTION Never immerse the meter iPhone or iPod touch Apple Lightning to 30 pin Adapter Apple Lightning to 30 pin Adapter 0 2m or the body of the lancing device in water or any other liquid solution Be careful when disinfecting your meter and iPhone or iPod touch Avoid getting liquid into the test strip port micro USB port or onto dock connector When should you clean and disinfect your meter iPhone or iPod touch Apple Lightning to 30 pin Adapter or Apple Lightning to 30 pin Adapter 0 2m and lancing device Since you are the only person operating them we recommend that you clean and disinfect once a week If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person The disinfection instructions listed below were validated for 260 cleaning disinfection cycles for a total of 520 wipes 260 cleaning wipes Important Disinfection Procedures plus 260 disinfecting wipes on the iPod touch 4th and 5th generation iPhone 4 and 5 Apple Lightning to 30 pin Adapter Apple Lightning to 30 pin Adapter 0 2m lancing device and iBGStar meter The life of the iBGStar defined as 5 000 test strip insertions is between 3 to 5 years depending on use The number of cleaning and disinfecting wipes used simulates cleaning and disinfecting your meter once a week for
37. ied below The customer or the user of the Model iBGSTAR should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Model iBGSTAR uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The Model iBGSTAR is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Electromagnetic Compatibility EMC Guidance and manufacturer s declaration electromagnetic immunity The Model iBGSTAR Image Intensifier is intended for use in the electromagnetic environment specified below The customer or the user of the Model iBGSTAR Image Intensifier should assure that it is used in such an 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 Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 E
38. isplay an animation showing that the meter is calculating the test result Test in progress BEEP The entire visual fi ll window must turn red Sample applied symbol 1 2 3 Calculating Animation WARNING If the visual fi ll window does not completely fi ll you may get an inaccurate result Retest and ensure that the visual fi ll window is completely full 52 53 How to Test Your Blood Glucose Level Example Result 8 Viewing Blood Glucose Test Result The blood glucose test result will appear on the meter display The unit of measure mg dL time and date of testing will scroll to the right of the blood glucose test result The test result is stored in the meter s memory In addition if the meter is connected to an iPhone or iPod touch and the app is launched the scorecard with reading will appear on the iPhone or iPod touch s screen 9 Remove the Used BGStar Test Strip From the iBGStar Meter s Test Strip Port Avoid touching the test strip s sample area where blood was applied The blood glucose 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 When using your iBGStar meter independently removing the used test strip will deactivate your meter To manually deactivate the meter press and hold the meter button until the meter deactivates When using your meter
39. lanced Press the release button Obtain a Drop of Blood Wipe away the first blood drop that appears using a clean tissue or paper towel Squeeze from the base of your finger up towards the tip until a second small blood drop forms Do not squeeze directly around the lanced area Do not perform a test while a cable is plugged into the micro USB port and the meter s battery is charging The meter cannot perform a test while it 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 meter If you connect your meter to your iPhone or iPod touch and insert a test strip into the meter before launching the app the app will not play an animation of a sample being applied to a test strip If you do not start the test within 4 minutes of inserting a test strip the meter will display the battery status and charging symbol To continue testing take out the unused BGStar Test Strip and reinsert it into the meter Avoid touching the test strip s sample area where blood should be applied Apply Sample to Test Strip Animation How to Test Your Blood Glucose Level Release Bu
40. le Used to connect the meter to the power adapter or a PC 2 Micro USB Connector Cable This end inserts into the meter s micro USB port 3 USB Connector Cable This end inserts into the power adapter or a PC s USB port 4 Power Adapter Used to charge your meter It will also charge the iPhone or iPod touch if the meter is connected to the iPhone or iPod touch Insert plug into a wall outlet 100 240v 50 60 Hz 5 Power Adapter s USB Port Used to connect to the iBGStar meter via the micro USB to USB cable IMPORTANT Use BGStar Blood Glucose Test Strips only once Only use BGStar Test Strips with the BGStar or iBGStar Blood Glucose Monitoring System s Important test strip information 1 Store the BGStar Blood Glucose Test Strip vial in a cool dry place at 46 F to 86 F 8 C to 30 C 2 Use BGStar Blood Glucose Test Strips only within the system operating temperature range of 50 F to 104 F 10 C to 40 C 3 Keep away from direct sunlight and heat 4 Store your BGStar Blood Glucose Test Strips in their original vial only Never store them in another vial any other container or outside the vial 5 With clean dry hands you may gently handle the BGStar Blood Glucose Test Strip when removing it from the vial or inserting it into the iBGStar 6 After removing a BGStar Blood Glucose Test Strip from the vial immediately close the vial cap tightly 7 Do not use BGStar Blood Glucose
41. lectrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 11 Voltage dips short interruptions and voltage variations on power supply input lines lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 s 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles lt 5 UT gt 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the Model iBGSTAR image intensifier requires continued operation during power mains interruptions it is recommended that the Model iBGSTAR Image Intensifier be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m If image distortion occurs it may be necessary to position the Model iBGSTAR image intensifier further from sources of powe
42. me and date 64 65 The iBGStar Blood Glucose meter will store up to 300 of the most recent blood glucose and control solution test results with time and date When the meter needs to save a new test result and has already stored 300 test results the oldest test result will be deleted and a new test result will be saved In order to view stored test results on your iBGStar meter A The meter must be disconnected from the iPhone or iPod touch OR B The meter is connected to the iPhone or iPod touch with the iBGStar Diabetes Manager Application closed 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 1 Viewing the most recent test result Press and release the meter button once The iBGStar meter will display the most recent test result and will be indicated 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 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
43. n in to your iTunes account or create a new account if needed NOTE Carrier charges may apply for downloading the app CHAPTER How to Install and Update the iBGStar Diabetes Manager Application 3 CHAPTER How to Install and Update the iBGStar Diabetes Manager Application Downloading the app through iTunes 1 Ensure you have iTunes installed on your computer or download it for free from http www apple com itunes 2 Launch the iTunes application 3 Click on iTunes Store in the left side of the screen 4 Enter iBGStar into the search box located in the top right hand corner of the screen 5 Locate the app icon and click FREE to begin the download process When prompted sign in to your iTunes account or create a new account if needed and follow the onscreen instructions 6 Once iTunes has completed downloading the iBGStar App connect your iPhone or iPod touch to your computer using the Apple Dock Connector to USB Cable The cable was included with your iPhone or iPod touch 7 On the menu on the left hand side Devices will appear Click on your device name 8 At the top of the screen click on App You will see a list of apps and an image of the device screen 9 Click on the Sync app button in the upper left of the screen if it is not already checked 10 If a message appears asking if you want to sync apps click Sync Apps How to Install and U
44. ng the iBGStar meter keep away from sources of electromagnetic disturbances such as electric motors or radio transmitting equipment The meter should not affect the normal operation of other devices If this does occur provide more distance between the meter and the affected device Your meter is an electronic device 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 for the period of ownership as long as it has not been modified altered or misused Under this warranty sanofi aventis U S will replace free of charge Your Meter if it is defective in material or workmanship If You wish to return Your Meter call 1 800 633 1610 No other warranties express or implied are made Sanofi aventis U S will not be liable for any incidental or consequential damages so the above limitations or exclusions may not apply to You This Warranty gives You specific legal rights and You may also have other rights that vary from state to state Sanofi aventis U S may discontinue this program at any time without notice Warranty 20 CHAPTER Warranty 84 85 Warning This devic
45. ntaining a minimum distance between portable and mobile RF communications equipment transmitters and the Model iBGSTAR as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 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 Electromagnetic Compatibility EMC 90 November 2013
46. ntrol protocols 11 Always follow your healthcare professional s recommendations The ADA recommends the following treatment goals for most individuals with diabetes A1C lt 7 pre meal glucose of 70 3 9 to 130 mg dL and a glucose taken within one to two hours after the start of the meal of lt 180 mg dL Treatment goals are individualized for each patient Speak with your healthcare provider about the target blood glucose ranges that are right for you WARNING The information from your iBGStar Diabetes Manager Application on your iPhone or iPod touch and blood glucose meter should only be used as a reference Do not make treatment decisions based solely on the information provided by the app All health related decisions should be made in conjunction with the advice of a qualified healthcare professional HCP It is important for you and your HCP to understand how the statistics are calculated before making any adjustments to treatment This information can be found in the iBGStar Diabetes Manager Application User s Guide available at http ibgstar com web app or read the instructions built into the app Important Health related Information Important Health related Information 4 Please read the following 1 Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis
47. on icon on your iPhone or iPod touch to launch the app The app will display the most recent 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 battery symbol will appear on your meter s display 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 you insert the test strip with the contact bars facing towards you into the test strip port You cannot perform a test while a cable is plugged into the micro USB port and the meter s battery is charging Example Results 48 49 5 Lancing To ensure accurate results wash hands with warm soapy water and dry before every glucose test For details on possible test sites refer to Chapter 5 For instructions on how to test on your palm or forearm please refer to Chapter 11 Keep your hand warm or gently massage the site you are lancing to stimulate blood flow Lance Test Site Press the lancing device against the site to be
48. one or iPod 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 How to Perform a Control Solution Test Example Results Level 2 90 150 mg dL FOR EXAMPLE ONLY Refer to your test strip vial label for corresponding range EXAMPLE EXAMPLE Level 4 220 320 mg dL If your control solution test results are out of the range repeat the test and 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 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 When using your iBGStar meter independently removing the used test strip will deactivate your meter When using your meter with the app
49. ons on how to use your iPhone or iPod touch refer to the support materials for each device Important Health related Information 1American Diabetes Association Standards of Medical Care in Diabetes Position Statement Diabetes Care 2011 34 suppl 1 S11 S61 24 25 It is recommended that you use a fingertip sample if 1 You are testing for hypoglycemia or if you suffer from hypoglycemia unawareness 2 You are testing your blood glucose within 2 hours of eating taking insulin medication exercise 3 Your blood glucose results obtained from the palm at the base of the thumb or forearm are not consistent with the way you feel CAUTION Please read all the instructions provided in this owner s guide and practice the testing procedures before using the iBGStar meter Home blood glucose monitoring should be done with the guidance of a health care professional CAUTION To ensure accurate results wash your hands and the test site with warm soapy water and dry before and after every test Unwashed hands and test sites may lead to inaccurate results Make sure there is no grease oil or lotion on the test site Use lancets only once Do not use any lancet or lancing device that has been used by another person Important Information About Your iBGStar Blood Glucose Monitoring System Possible test sites The iBGStar Blood Glucose Monitoring System only requires a small droplet of blood 0 5 L about the size of a
50. owards you into the meter s test strip port 4 Sample Area Blood or control solution should be applied to the tip of the test strip here 5 Visual Fill Window This window will turn red when enough blood has been applied or blue when enough control solution has been applied About the iBGStar Blood Glucose Monitoring System 2 CHAPTER About the iBGStar Meter the meter 1 Dock Connector Cover Covers the dock connector when not in use 2 Dock Connector This end inserts into the iPhone or iPod touch s 30 pin dock connector port The dock connector port is located below the home button of either device 3 Display Area Glucose test results symbols and messages appear here 4 Meter Button The right side of the meter s display is a button It is used to activate or deactivate the iBGStar and view past test results 5 Micro USB Port Used to connect to the power adapter or a PC personal computer via the micro USB to USB cable 6 Test Strip Port Insert the BGStar Blood Glucose Test Strip with the contact bars facing up into the test strip port 4 3 1 2 5 1 5 3 4 6 About the iBGStar Blood Glucose Monitoring System About the iBGStar Blood Glucose Monitoring System 2 8 9 9 Apply only fresh capillary blood or control solution to the sample area of the BGStar Blood Glucose Test Strip About the Micro USB to USB Cable and Power Adapter 1 Micro USB to USB Cab
51. palms at the base of the thumb or forearms 2 For in vitro i e outside of the body diagnostic use only 3 With BGStar Blood Glucose Test Strips and BGStar Control Solution only Do not use other brands of test strips and control solution with the meter This may produce inaccurate results 4 For use at home over the counter OTC by persons with diabetes or in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control Do not use the iBGStar Blood Glucose Monitoring System for 1 The diagnosis of diabetes 2 Testing the glucose levels of neonates children under 4 weeks of age 3 Testing glucose levels of arterial or venous blood 4 Testing glucose from sites other than the fingertip palm at the base of the thumb or forearm Important Information About Your iBGStar Blood Glucose Monitoring System For instructions on how to use the iBG Star Diabetes Manager Application refer to the User s Guide available at http ibgstar com web app or read the instructions built into the app IMPORTANT Please note that the iBGStar Diabetes Manager Application stores sensitive health related information on your iPhone or iPod touch We recommend keeping your iPhone or iPod touch up to date with the latest security software For more information on keeping your iPhone or iPod touch and information safe visit http www apple com support security For instructi
52. pdate the iBGStar Diabetes Manager Application 16 17 Once inserted your iPhone or iPod touch will display a message asking if you d like to install the necessary app Touch the Yes button to install the app on your device You must have internet access to download the app The app icon and a progress bar will appear on the iPhone or iPod touch s screen How to update the app As new features are added to the app updates will be made available through the App Store Updating the app through your iPhone or iPod touch 1 Anytime there is an update to an app on your iPhone or iPod touch a number will appear on the App Store icon to indicate the number of updates available To view the updates tap on the App Store icon How to Install and Update the iBGStar Diabetes Manager Application 11 In the list of apps find the iBGStar Diabetes Manager Application and check the box next to iBGStar Diabetes Manager 12 Click Apply in the lower right hand corner of the screen 13 After syncing is done unplug your iPhone or iPod touch and you are ready to use the app These instructions are subject to change For more information on downloading apps from the App Store or syncing your iPhone or iPod touch refer to the Help section of iTunes How to install the app using your iBGStar Meter 1 Ensure that your iPhone or iPod touch is on and the home screen is showing 2 Connect your meter to you
53. pple 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 or iPod touch The first time you connect an iBGStar meter to the iBGStar App on your iPhone or iPod touch you will be prompted with 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 downloaded from the meter to the app Syncing will also set the meter to match the iPhone or iPod touch s time and date Select Cancel to cancel the download The meter will not 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 able to download readings from your meter to the app 62 63 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 this is your first time connecting the meter follow instructions in Chapter 12 After the fi rst sync between an iBGStar Meter and the app syncing will happen automatically when You connect the meter to your iPhone or i
54. r 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 UT is the a c mains voltage prior to application of the test level Electromagnetic Compatibility EMC 88 89 Guidance and manufacturer s declaration electromagnetic immunity The Model iBGSTAR is intended for use in the electromagnetic environment specified below The customer or the user of the Model iBGSTAR should assure that it is used in such an environment IMMUNITY test IEC 60601 TEST LEVEL Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the Model IBGSTAR including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marke
55. r iPhone or iPod touch by inserting the meter s dock connector into the iPhone or iPod touch s dock connector port with both displays facing up The dock connector port is located below the home button of either device How to Install and Update the iBGStar Diabetes Manager Application 18 19 9 If a message appears asking if you want to Sync Apps click Sync Apps 10 In the list of apps find the iBGStar App and check the box next to iBGStar Diabetes Manager 11 Click Apply in the lower right hand corner of the screen 12 After syncing is done unplug your iPhone or iPod touch and you are ready to use the iBGStar App These instructions are subject to change For more information on downloading apps from the App Store or syncing your iPhone or iPod touch refer to the Help section of iTunes NOTE Updating the app will not cause you to lose your data Any information currently contained in the app such as blood glucose readings will not be affected by updates How to Install and Update the iBGStar Diabetes Manager Application 2 Tap on the Updates icon 3 If there is an update available for the iBGStar Diabetes Manager Application it will appear in the list of updates Tap Update to update the app Updating the app through iTunes 1 Launch the iTunes application 2 On the left side of the screen click on Apps located under the Library 3 If there are updates for an
56. rganization or supplemental data display tool and not as a source of medical advice You agree that this software will never be used to replace the advice of a doctor or your own common sense and independent judgment and that you will not at any time rely on any information presented on your Apple Product as the basis for health care medical or other decisions that may result in injury or other ill effects You agree to take sole responsibility for your health care decisions including contacting a physician or other health care professional regarding all medical conditions tests diagnoses and treatment options and agree that Apple shall have no liability for any action you or anyone using the software may take regardless of the information received displayed calculated or transmitted by your Apple Product Apple assumes no risk for your use of the software and makes no warranties whatsoever express or implied regarding the accuracy completeness or usefulness of any information presented on your Apple Product as a result of using the software Manufacturer AgaMatrix Inc 7C Raymond Avenue Salem NH 03079 USA Distributed by sanofi aventis U S LLC Bridgewater NJ 08807 2013 sanofi aventis U S LLC Meter Firmware 2013 AgaMatrix Inc All rights reserved All trademarks and or copyrights are the property of their respective owners US and International patents pending iPhone iPod iPod touch and iTunes are trademarks of Apple Inc r
57. s Warranty Electromagnetic Compatibility EMC 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 CHAPTER PAGE PAGE CHAPTER 4 6 14 20 23 26 30 33 41 44 56 60 62 64 67 70 76 80 81 83 84 TITLE TITLE Contents Contents 4 5 The System Kit contains Owner s Guide Reference Guide Registration amp warranty Card and Carrying Case not shown Getting Started 1 CHAPTER Unpack your System Kit Dispose of the packing material properly Charge the iBGStar Meter s battery by following instructions in Chapter 18 IMPORTANT To ensure accurate use of the iBGStar Meter the meter or iBGStar Diabetes Manager Application the app the time and date must be correctly set on your iPhone or iPod touch For instructions on how to set the time and date on your iPhone or iPod touch refer to the support materials for each device The time and date from your iPhone or iPod touch will be used to set the time and date on your meter whenever it syncs For step by step instructions on setting time and date for the first time refer to Chapter 13 System requirements iPhone or iPod touch with at least 30 MB of available space 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 Made for iPhone 3G 3GS 4
58. se of the thumb or forearm Remove Lancing Device Cap How to Test Your Blood Glucose Level Example Results How to Test Your Blood Glucose Level 10 CHAPTER How to Test Your Blood Glucose Level Snap off the cap from the lancing device Insert New Lancet Insert a new lancet firmly into the lancet holder cup as shown in the picture below Pushing the lancet into the lancet holder cup may cock the device this is OK Twist the Lancet Cover Off Hold the lancet firmly in place with one hand and use your other hand to twist off the lancet cover Keep the lancet cover It should be used when discarding your used lancet Replace Lancing Device Cap Replace the lancing device cap until it snaps into place Be careful not to touch the exposed needle on the lancet 46 47 How to Test Your Blood Glucose Level Set the Lancing Level The BGStar Lancing Device offers 8 depth settings Rotate the dial to the desired setting as shown in the depth indicator window Level 1 is the shallowest level 8 is the deepest If you have never lanced before it is recommended that you start at level 3 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 2 Launching the App and Connecting Skip to step 3 if testing without the app Tap the iBGStar Diabetes Manager Applicati
59. sing a new test strip Ensure that enough whole blood is applied to the test strip when retesting 2 The sample may not be blood or control solution Retest using a new test strip Ensure that the test site is clean prior to performing a blood glucose test or that the control solution bottle tip is wiped clean prior to performing a control solution test Error 3 The meter has detected that the test strip is in poor condition 1 The test strip may have been improperly stored e g hot humid conditions or may be expired Check the test strip vial for the expiration date Do not use test strips beyond the expiration date or 180 days after first opening the vial You may need to retest using a new test strip from a new vial of test strips Error Messages and Troubleshooting 72 73 2 The test strip may have been mishandled by vigorous bending or shaking Retest using a new test strip 3 Parts of the test strip may have become covered in grease oil or lotion Retest using a new test strip 4 The test strip port connector may be dirty Call Customer Service for assistance at 1 800 633 1610 The phone number is also printed on your meter s cap label Error 4 The meter was unable to produce a result or unusual test strip problems have occurred that may be related to extreme conditions 1 This error may be caused by extremely high glucose If you are experiencing symptoms of hyperglycemia contact your healthcare prof
60. team or contact your healthcare professional immediately Display Messages 15 CHAPTER 68 69 HIGH MESSAGE MEANING Glucose test result is above 600 mg dL This high 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 gt 600 mg dL with time and date The value will be represented as 600 mg dL in the statistics in the app ACTIONS If you feel symptoms such as fatigue thirst excessive urination or blurry vision follow your healthcare professional s recommendations If you get a high glucose test result but have no symptoms of high blood glucose then retest with a new BGStar Test Strip If you still get a high glucose test result follow your healthcare professional s recommendations Checking ketones may be advisable LOW TEMPERATURE MESSAGE MEANING The iBGStar Blood Glucose Monitoring System is below its operating temperature range of 50 F to 104 F 10 C to 40 C ACTIONS Move to an area with 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 ambient
61. the lancing device bring the lancet tip to the lancet cover to recover the used lancet You can then safely handle the used 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 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 5 56 57 Obtaining a Blood Sample From Alternative Sites Palm or Forearm 11 CHAPTER Testing glucose levels with blood obtained from the palm at the base of the thumb or forearm may reduce the 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 professional 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
62. to discard the first drop of control solution and to wipe the bottle tip clean Important Information About Performing Control Solution Tests How to Perform a Control Solution Test 8 CHAPTER This chapter explains how to perform a control solution test with the iBGStar Diabetes Manager Application the app To perform a control solution test using the iBGStar Meter independently Skip step 1 and begin with step 2 You must sync your meter to the app to be able to download readings from your meter to the app and set your meter s time and date For instructions on how to sync for the first time refer to Chapter 12 Test results without a set time and date Will be saved to the meter in chronological order but will not download to the app Test results without a set time and date be displayed on your meter with and in place of the time and date If have you synced your iBGStar meter to the app previously and you see dashes in place of the time and date you need to re sync your meter with the app Readings that do not have a time and date associated with them will not download to the app You can manually add these readings to the app to include them in your statistics For best results frequently sync the meter with your app 1 Launching the App and Connecting Tap the iBGStar Diabetes Manager Application icon on your iPhone or iPod touch to launch the app The most recent scorecard or the
63. tton How to Test Your Blood Glucose Level 50 51 Apply Sample to Test Strip Animation This is the visual fi ll window Do not apply blood here APPLY BLOOD HERE How to Test Your Blood Glucose Level 6 Applying Blood Sample The meter should still display the Apply Sample to Test Strip Animation Bring Test Strip to Blood Sample Immediately bring the BGStar Test Strip to the blood sample The test strip fills from the tip Do not try to smear blood on the top surface The BGStar Test Strip acts like a sponge and draws the blood into the test strip through the sample area The visual fill window of the BGStar Test Strip will turn red How to Test Your Blood Glucose Level 7 Remove Your Finger From the Test Strip When the Test Strip s Visual Fill Window Completely Turns Red The sample applied symbol 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 indicates that a sample has been applied to the test strip and the meter is calculating the test result In addition if the meter is connected to an iPhone or iPod touch and the app is launched the app will d
64. y of your apps available the lower right of the screen will display that you have a number of updates available Click on the arrow next to Updates Available 4 If there is an update available for the iBGStar Diabetes Manager Application the app icon will be displayed Click on Get Update next to the icon Enter your Apple ID and password 5 Once iTunes has completed downloading the app update connect your iPhone or iPod touch to your computer using the Apple Dock Connector to USB Cable The cable was included with your iPhone or iPod touch 6 On the menu on the left hand side Devices will appear Click on your device name 7 At the top of the screen click on App You will see a list of apps and an image of the device screen 8 Click on the Sync App button in the upper left of the screen if it is not already checked How to Install and Update the iBGStar Diabetes Manager Application 20 21 8 If you get repeated error messages and are experiencing symptoms of hypo or hyperglycemia contact your healthcare professional immediately as this may indicate low or high glucose If this error code persists on retesting consult your healthcare professional see Chapter 17 Error Messages and Troubleshooting 9 Do not use test strips that are expired or appear to be damaged as they may return inaccurate results 10 Healthcare professionals should follow their institution s infection co

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