Lifescan InDuo blood glucose meter User's Manual
Contents
1. DInDuo xe 110 isk bbe www nDuo co Diagram of the InDuo system Look at the diagram inside this cover for the names of the different parts of the InDuo system You can unfold the diagram to help you while you follow the instructions The InDuo system should be used only in combination with products that are compatible with it and allow the InDuo system to function safely and effectively OneTouch Ultra test strips are designed to be used with the InDuo blood glucose meter PenFill 3 mL cartridges and NovoFine needles are designed to be used with the InDuo insulin doser PenFill not included PenFill and NovoFine are trademarks of Novo Nordisk A S IN TOUCH and OneTouch are trademarks of LifeScan Inc InDuo is a trademark of Johnson and Johnson Co Protected by US Patent Nos 5 957 889 5 961 496 and 6 045 537 Additional patents pending The CE mark on the InDuo doser indicates that the product conforms with the provisions in the EC Directive for Medical Devices 93 42 EEC The InDuo insulin doser fulfils the specification limits for dose accuracy according to ISO 11608 1 Pen Injectors for Medical use Part 1 Requirements and test methods InDuo SYSTEM AND ACCESSORIES OneTouch UltraClear OneTouch U traSoft cap for alternate Sterile Lancet puncture site Ultra ONETOUCH InDuo OneTouch Ultra One2. A OneTouch Ultra test strips Top edge Apply a sample here where the narrow Your InDuo meter is designed for use with channel meets the OneTouch Ultra test strips only top edge of aD uita e Store the OneTouch Ultra test strip package in a cool dry place below 30 C 86 F Keep away from direct sunlight and heat Do not refrigerate e Store your OneTouch Ultra test strips in their original vial only do not transfer them to a new bottle or any other container e After removing a OneTouch Ultra test strip from the vial immediately replace the vial cap and close it tightly e With clean dry hands you may touch the test strip anywhere on its surface when removing it from the vial or inserting it into the meter Insert this end of e Use each OneTouch Ultra test strip immediately OneTouch Ultra after removing it from the vial test strip into the e Write the discard date on the vial label when you Ipua merer 0 it for the first time Discard remainin pen i 9 OneTouch Ultra test strips and the vial 3 months after the vial was first opened Confirmation window This is where you confirm if a large enough sample has been applied to the top edge Contact bars GETTING YOUR InDuo SYSTEM READY FOR USE 11 e Apply only control solution or a blood sample to the top edge of the OneTouch Ultra test strip Applying other substances to the top edge may cause inaccurate results e Do n
3. 50 INJECTING YOUR INSULIN InDuo insulin doser function check You should regularly check the functioning of your InDuo insulin doser For example once a month or before starting a new box of PenFill cartridges You should also check the functioning of the InDuo insulin doser if you think that it is not working properly Screw on a new NovoFine needle as described on page 41 Prime the insulin doser as described on page 42 Put the outer needle cap over the needle Dispense 20 units into the outer needle cap The insulin should fill the lower part of the outer needle cap If too much or too little insulin is released repeat the test If the InDuo insulin doser again releases too much or too little insulin do not use your insulin doser Do not try to repair a faulty insulin doser Call InDuo Customer Services at our toll free number 1 877 520 9056 USING THE InDuo MEMORY FUNCTIONS 51 A USING THE InDuo MEMORY FUNCTIONS Example Both the InDuo meter and the InDuo insulin doser have memory functions Checking your previous test results Your InDuo meter has a memory that can store the 150 most recent blood glucose and control solution test results together with the date and time at which they were carried out ELS mg dL 15 BHn Using the memory mode Enter the memory mode e With the meter turned off press W Q e
4. e Obtain a rounded drop of blood from your finger using the blood sampler The blood sample must be at least 1 microliter in volume e actual size of rounded drop to fill the confirmation window or you may get an F5 or possible inaccurate test result See page 32 for how to obtain a drop of blood e When the apply symbol appears on the display touch and hold the drop of blood to the top edge of the OneTouch Ultra test strip where it meets the narrow channel Do not push your finger against the test strip or try to apply a smeared sample Do not apply blood to the front or back of the test strip e Hold the blood drop to the top edge of the test strip until blood has completely filled the confirmation window before the meter begins to count down The InDuo meter display will begin to count down from 5 to Correct 38 TESTING YOUR BLOOD GLUCOSE LEVELS Good sample Sample too small 7 If the confirmation window does not fill completely before the meter begins to count down do not add more blood to the test strip discard the test strip and repeat the test with a new test strip Ensure sufficient sample Do not use a smeared sample Hold the test strip in contact with blood If you have trouble filling the test strip call InDuo Customer Services at 1 877 520 9056 for assistance If you do not apply a blood sample within 2 minutes the meter will turn off automatically You must
5. Point the lancet down and away Push forward on the ejection cocking control and eject the lancet directly into an appropriate container for sharp objects Return the ejection cocking control to the middle position Replace the cap 36 TESTING YOUR BLOOD GLUCOSE LEVE Cleaning the OneTouch UltraSoft blood sampler e Clean the sampler with soap and water as needed To disinfect the sampler prepare a disinfectant solution of 1 part household bleach to 10 parts water Dampen a cloth in this solution and wipe the sampler thoroughly Soak only the cap for at least 30 minutes in the disinfectant solution Do not soak the sampler in liquid Rinse the sampler and cap with water and dry thoroughly Performing a blood glucose test on your blood sample Insert the OneTouch Ultra test strip e Insert the OneTouch Ultra test strip contact bars end first and facing up into the test port Push the OneTouch Ultra test strip in firmly until it will go no further e The InDuo meter will turn on automatically All segments on the meter display will appear briefly Then the code number is displayed followed by the apply symbol amp with the units of measurement mg dL or mmol L Verify that the calibration code and units of measurement are set TESTING YOUR BLOOD GLUCOSE LEVELS 37 correctly See page 9 for additional information on the units of measurement e Code the meter if necessary Apply blood sample
6. injection discard the NovoFine needle safely TESTING YOUR BLOOD GLUCOSE LEVELS 27 N TESTING YOUR BLOOD GLUCOSE LEVELS Be sure to read this section Important Information on page 65 and the OneTouch Ultra test strip package insert found in this system kit box carefully before testing Before using your InDuo meter to test your blood glucose level check that you have all the items needed to complete the procedure These are e InDuo meter e OneTouch Ultra test strips e OneTouch UltraSoft Sterile Lancets e OneTouch UltraSoft Adjustable Blood Sampler e OneTouch U traClear Cap for alternate puncture site 28 TESTING YOUR BLOOD GLUCOSE LEVELS 7 Check that the InDuo meter display is working properly You will know the meter display is working properly because each time the InDuo meter is turned on all the segments of the meter display appear briefly see InDuo meter and insulin doser display symbols in cover flap After checking that the InDuo meter display is working you are ready to obtain a drop of blood and to do a blood glucose test When carrying out a blood glucose test keep the risk of infection to a minimum by observing the following precautions A Caution e Never share a lancet or the blood sampler with anyone e Always use a new sterile lancet every time you take a blood sample Lancets are for single use only e Av
7. The 14 day average will appear indicating that you are in the memory mode After 3 seconds the 30 day average will appear for 3 seconds e You can now recall the last 150 test results in the meter memory see page 52 am Vam mg dL 3 alal e You can also enter memory mode from the test mode After completing a blood glucose or control solution test and while the test result is still on the display press to enter the memory mode 52 USING THE InDuo MEMORY FUNCTIONS a How to recall test results After 3 seconds the 30 day average will be replaced by the most recent test result with date and time Press once and the next most recent test result will appear Each time you press and release E the meter will recall your last test results in order up to 150 When the meter memory is full the oldest result is dropped as the newest is added To scroll through the test results more quickly press and hold amp Control solution test results will appear on the display with ctl mem When using the meter for the first time mem will appear showing that there are no test results in the memory Exit the memory mode Press to turn off the meter USING THE InDuo MEMORY FUNCTIONS 53 Other memory functions of the InDuo meter The InDuo meter can provide valuable information on variations in your blood glucose levels Averag
8. You should treat this condition according to recommendations of your health care professional INJECTING YOUR INSULIN A Before beginning read Important Information on page 65 To begin preparation for injecting your insulin pull out the InDuo insulin doser Do not press any buttons on the meter cap while you remove the insulin doser Attach a NovoFine needle You will then be ready to prime your insulin doser and dial your insulin dose If your InDuo insulin doser contains an insulin suspension cloudy insulin you must resuspend the insulin by turning the InDuo insulin doser up and down as described in the PenFill Information For The Patient How to attach a NovoFine needle e Pull out the InDuo insulin doser e Wipe the front rubber stopper of the PenFill with an alcohol swab e Take the protective tab off the NovoFine needle and screw the needle tightly onto the insulin doser e Pull off the outer and inner needle caps before priming your insulin doser INJECTING YOUR INSULIN 41 z 8 S g 42 INJECTING YOUR INSULIN g How to prime your InDuo insulin doser e Make sure that a NovoFine needle is attached IZE see page 24 the push button is pressed in completely and the slide is closed If the slide is not closed the release button will be locked Press the release button You will see that the push button jumps out Dial unit When insert
9. arm testing on the previous page carefully Install the Clear Cap To aid in obtaining a blood sample from the arm replace the regular sampler cap with the clear cap If necessary set the sampler for a deeper puncture Choose the Puncture Site Select a soft fleshy area on your arm that is away from bone and free of visible veins and excess hair Massage the Area Massaging the area gently or applying heat to it briefly will increase blood flow to the puncture site Position the Sampler Press and hold the sampler against the arm for a few seconds Press the release button TESTING YOUR BLOOD GLUCOSE LEVELS 35 Allow Blood Drop to Form Continue holding the sampler against the skin for a few seconds until the blood drop forms Allow enough blood to form under the cap until you have a blood sample that is sufficient to fill the confirmation window of the test strip If bruising occurs you may choose to lance a fingertip instead If you are having difficulty obtaining blood from the arm call InDuo Customer Services at 1 877 520 9056 for assistance The blood sample must be at least 1 microliter in volume or you may get an E 4 or possible inaccurate test result Removing the lancet e To remove the cap twist it counterclockwise e Optional To replace the protective disk on the lancet place the disk on a hard surface and push the exposed tip into the protective disk A Always use caution when removing the lancet
10. of the range printed on the vial the InDuo system may not be working properly Do not use the InDuo system to continue testing your blood if the control solution test results continue to fall outside the expected range e If you are unable to resolve the problem call InDuo Customer Services at our toll free number 1 877 520 9056 20 GETTING YOUR InDuo SYSTEM READY FOR USE The control solution test troubleshooting There are several reasons why a control solution test result may fall outside the expected range as printed on the OneTouch Ultra test strip vial label Probable reasons Error in performing the test Failure to shake the OneTouch Ultra _ repeat the test control solution vial vigorously Expired or contaminated OneTouch Ultra control solution InDuo meter OneTouch Ula E control solution or test strips that are too warm or too cool Failure to discard the first drop of OneTouch Ultra test strip deterioration InDuo meter malfunction Improper coding of the meter Repeat the test closely following the _ instructions on pages 16 18 Shake the control solution vial and Check the expiration date o or use new control solution Check that the room n temperature is 5 between 68 77 F 20 25 Repeat the test OneTouch Ultra control solution Repeat the test with a new vial of test strips Remembe
11. printed on the OneTouch Ultra test strip vial is for OneTouch Ultra control solution only It is used to test meter and OneTouch Ultra test strip performance It is not a recommended range for your blood glucose level 16 GETTING YOUR InDuo SYSTEM READY FOR USE Before you use your InDuo meter to test your blood for the first time practice the procedure using the control solution test When you can do three tests in a row that are within the range printed on the OneTouch Ultra test strip vial you are ready to test your blood How to do a control solution test Insert OneTouch Ultra test strip e Insert a OneTouch Ultra test strip contact bars end first and facing up into the test port Push the OneTouch Ultra test strip in firmly until it will go no further e The InDuo meter will turn on automatically e All segments will appear briefly on the meter display Then the code number is displayed followed by the apply symbol amp with the units of measurement mg dL or mmol L e Verify that the calibration code and units of measurement are set correctly See page 5 and 9 for additional information on the unit of measurement GETTING YOUR InDuo SYSTEM READY FOR USE 17 e After the apply symbol amp appears on the display press K e The etl symbol will appear on the display With the ctl symbol on the display the meter will mark your next test in the memory as a control solution
12. remove the test strip and insert it back into the InDuo meter to restart the test TESTING YOUR BLOOD GLUCOSE LEVELS 39 Read the results e Your blood glucose test result will appear after the InDuo meter counts down from to Turn off the InDuo meter by removing the OneTouch Ultra test strip Blood glucose test results are automatically stored in the InDuo meter memory e The InDuo meter provides accurate plasma calibrated test results that can be compared directly with laboratory results e Record all test results in your logbook This helps keep track of your test results Plasma Calibrated Test Result Example 40 TESTING YOUR BLOOD GLUCOSE LEVELS lal fle ketones mg dL PRE Special messages HI If your blood glucose test result is above 600 mg dL 33 3 mmol L H will appear on the meter display This indicates severe hyperglycemia high blood glucose You should re check your glucose level and if call your health care professional immediately When your blood glucose test result is above 240 mg dL 13 3 mmol L or reads H ketones will appear on the meter display This message does not mean that the system detected ketones but that testing with a ketone test strip may be advisable LO If your test result is lower than 20 mg dL 1 1 mmol L will appear on the meter display This indicates severe hypoglycemia low blood glucose
13. sure to replace your InDuo insulin doser within 30 days The battery cannot be changed Call InDuo Customer Services at 1 877 520 9056 to obtain a new InDuo insulin doser A IMPORTANT INFORMATION As a precautionary measure always carry a spare insulin delivery system in case your InDuo doser is lost or damaged Always prime your InDuo insulin doser see page 24 to ensure the insulin flow e Before each injection e After changing PenFill e After changing the needle 9 After opening and closing the slide e When a PenFill is in the insulin doser never press the push button unless a needle is attached Before injecting always make sure the push button is pressed completely in and locks e The insulin doser display confirms completed delivery when the segments turn on two by two and then the circle symbol appears Do not change the dose after you have pressed the push button Always make sure that the insulin doser is inserted completely into the meter cap when not in use This shuts the power off e Your InDuo insulin doser is designed to work accurately and safely In the unlikely event that you cannot release the push button on your InDuo insulin doser it may be due to a malfunction and you should use another method such as a spare insulin delivery system to take your scheduled insulin doses e The InDuo system is tough but could still be damaged Handle it
14. test If you decide not to perform a control solution test press again and the etl symbol will disappear e Every time you perform a control solution test you must mark the test result with the ctl symbol so that the test will be distinguished from a blood glucose test in the memory and not included in the 14 day and 30 day blood glucose test averages 18 GETTING YOUR InDuo SYSTEM READY FOR USE Apply control solution e Shake the control solution vial well e Remove the cap e Squeeze the vial discard the first drop and wipe off the dispenser tip to obtain an accurate result Squeeze the vial again to get a small hanging drop Apply the hanging drop to the top edge area of the OneTouch Ultra test strip where it meets the narrow channel until the drop is drawn into the OneTouch Ultra test strip the confirmation window is filled and the meter display begins to count down E Example Read test results e The meter will count down from 5 to and the control solution test result will appear e Compare the result with the range printed on the OneTouch Ultra test strip vial label The result should fall within this range GETTING YOUR InDuo SYSTEM READY FOR USE 19 A Caution If the control solution test result falls outside the range printed on the OneTouch Ultra test strip vial repeat the test If you continue to get control solution test results that fall outside
15. unable to respond to computer commands Data transfer to computer e Follow the instructions in your IN TOUCH user s manual to begin transferring your blood glucose test results to your computer 9 If no command is received within 2 minutes the InDuo meter will turn off automatically e Pressing GJ will also turn off the InDuo meter e Follow the instructions in your IN TOUCH user s manual to view your blood glucose test results on your computer IN TOUCH Software which includes the LifeScan Interface Cable must be purchased separately To obtain the software and a LifeScan Interface Cable call InDuo Customer Services at 1 877 520 9056 58 COMPARING THE InDuo METER AND LABORATORY RESULTS g COMPARING THE InDuo METER AND LABORATORY RESULTS The InDuo meter blood glucose test results and laboratory results are both expressed in plasma equivalent units However you may notice a normal variation between the results you obtain using your meter and your usual laboratory results InDuo test results can be affected by factors and conditions that do not affect laboratory results in the same way Your InDuo meter glucose value should agree with a laboratory measurement within 20 most of the time under normal conditions A result within that range is considered accurate when testing with the InDuo meter However results can differ by more than 20 in some situations
16. with care do not drop it and avoid knocking it against hard surfaces If the InDuo system has been dropped or knocked you must carry out a function check of the insulin doser see page 50 and a control solution test see page 14 e Never use your InDuo system unless you are sure that it is working properly e Do not play with the dose selector or the push button as this can cause the InDuo insulin doser to wear out Keep the InDuo system PenFill and NovoFine needles out of the reach of children Your InDuo system is for use by one person only Before each injection make sure that you are using the right type of insulin If you are treated with more than one type of insulin in PenFill 3 mL cartridges you should use an InDuo insulin doser for one type of insulin e g arapid acting analogue and a different insulin delivery device such as Innovo for the other e g long acting insulin e Take the needle off the InDuo insulin doser immediately after each injection If you do not remove it temperature changes may cause liquid to leak out of the needle With an insulin suspension cloudy insulin a leak of liquid may change the concentration of the insulin Do not start injecting an insulin suspension cloudy insulin if the rubber stopper is below the arrow marks on the slide The glass ball must have adequate space to resuspend the insulin Instead you must replace the old
17. PenFill with a new one e Do not use the residual scale to measure the amount of insulin to be injected e Do not try to repair a faulty InDuo component The InDuo system must only be used according to the instructions in this manual The manufacturer will not be held responsible for any equipment problems if you have not followed the instructions Healthcare professionals relatives and other carers should follow general precautionary measures for removal and disposal of needles to minimize the risk of unintended needle penetration Keep the InDuo meter OneTouch Ultra strips and OneTouch Ultra control solution at the same relative temperature before testing Testing before the meter strips and control solution reach the same relative temperature may result in an inaccurate glucose reading 68 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE There are a number of messages and symbols that appear on the insulin doser and meter displays during use of the InDuo system The following is a summary of all display messages The meter gives an error message when it detects a problem which could cause an inaccurate result However the meter cannot detect all problems and for those it can detect may not produce an error message every time the problem occurs There may also be causes for the display of an error message that are not listed here Assistance is a
18. S ON A PERSONAL COMPUTER You can transfer blood glucose test results to your PC for home viewing This requires a LifeScan Interface Cable and IN TOUCH Diabetes Management Software which is available from LifeScan IN TOUCH Software and the LifeScan Interface Cable are not included with your InDuo system and must be obtained separately 56 VIEWING BLOOD GLUCOSE TEST RESULTS ON PC How to transfer glucose test results to your PC Install IN TOUCH software e Install IN TOUCH software on your computer following the instructions provided in the IN TOUCH user s manual Connect the LifeScan Interface Cable e Connect the LifeScan Interface Cable to a serial port on the back of your computer e With the InDuo meter turned off connect the LifeScan Interface Cable to the data port located on the top right corner of the InDuo meter e PE will appear on the display once the first command is received indicating that the InDuo meter is in the communication mode e You are now ready to transfer all test results together with the date and time they were made from the memory in your InDuo meter to your computer VIEWING BLOOD GLUCOSE TEST RESULTS ON 57 e While the InDuo meter is in the communication mode you cannot use the InDuo meter to perform a blood glucose test Similarly when the InDuo meter is in either the memory mode or the setting mode it is
19. See the OneTouch Ultra test strip package insert for typical accuracy and precision data and for important information on Limitations of Procedure Making an accurate comparison between the InDuo meter and laboratory results Before going to the laboratory e Perform a control solution test to check that the InDuo meter is working properly e It is best to fast for at least 8 hours before doing comparison tests e Take your InDuo meter with you to the laboratory At the laboratory e Make sure that the samples for both tests the meter test and the laboratory test are taken and tested within 15 minutes of each other e Wash your hands before obtaining a blood sample e Never use your InDuo meter with blood that has been collected in a grey top blood collection tube e Use fresh capillary blood only Other reasons for variation Besides the factors listed in the OneTouch Ultra test strip package insert there are other reasons for variations e Blood glucose levels can change significantly over short periods especially if you have recently eaten exercised taken medication or experienced stress e you have eaten recently the blood glucose level from a fingertip blood sample can be up to 70 mg dL higher than blood drawn from a vein venous sample used for a laboratory test It is therefore best to fast for 8 hours before doing a comparison test between an InDuo meter result and a l
20. Touch Ultra OneTouch UltraSoft Blood Glucose Meter Control Solution Test Strips Adjustable blood sampler InDuo NovoFine PenFill 3 mL Insulin Doser Needles 10 pack Insulin Cartridge InDuo BLOOD GLUCOSE METER AND INSULIN DOSER Data port Test port Dose selector Meter display LOT number M button o ES a gt C button Insulin doser display Push button Release button InDuo METER AND INSULIN DOSER DISPLAY SYMBOLS Ctl Indicates a control solution test result Code Appears with the 4 ctl ketones mem code number of the p a a OneTouch Ultra Test strip currently in use i lt a Apply symbol _ Lt pt Lt Tells when to apply EZ mmol L mg dL A 8 8508 Battery symbol Appears when the meter Month Day Hour Minutes battery power is low or must be replaced Ketones Appears when a blood glucose test result falls above 240 mg dL Mem Indicates a test result stored in the memory Test result area Test results are displayed here A decimal point appears when the unit of measurement is millimoles per liter Unit of measurement The meter has been pre set in either mg dL or mmol L Confirm that the unit of measurement is correct when the apply symbol appears during blood application Time segment The segments indicat
21. aboratory result e Physical factors such as the amount of red blood cells in the blood a high or low hematocrit or the loss of body fluids severe dehydration may also cause an InDuo meter test result to be different from a laboratory result References 1 Surwitt RS Feinglos MN Diabetes Forecast April 1988 49 51 2 Sacks DB Carbohydrates Burtis CA Ashwood BR ed Tietz Textbook of Clinical Chemistry Philadelphia PA W B Saunders Company 1994 959 CARING FOR YOUR InDuo SYSTEM e Your InDuo is a precision instrument To ensure it works accurately and safely handle it with care e Avoid situations where your InDuo component parts can be damaged e Store InDuo in its carrying case after each use e Always replace the meter cap after using your InDuo insulin doser e Please read the Information for The Patient in the PenFill pack This will tell you how to store PenFill cartridges and how long to keep them e With a PenFill cartridge inserted store your InDuo at room temperature up to 77 F 25 Q Follow the guidelines on insulin storage supplied in the PenFill Information for The Patient Do not refrigerate your InDuo As no blood or control solution comes in contact with the meter there is no special cleaning required Take care to avoid getting dirt dust blood control solution or water inside the InDuo through the test port or data port Clean off d
22. e answers to some questions you might ask about your InDuo insulin doser display Why has the display turned off If the display goes off press the release button and the push button will jump out Press the push button completely in and the display should reappear If the display does not reappear open and close the slide Prime the InDuo insulin doser as described on page 24 If the display remains off the insulin doser is not working Do not use the insulin doser Call InDuo Customer Services at 1 877 520 9056 to get a replacement Why is the display showing a minus symbol The dose selector has been dialed below zero Dial forward until the display shows the correct number of units Why does the display not respond when I turn the dose selector Press the release button so that the push button jumps out before a dose can be dialed Here are the answers to some questions you might ask about priming the insulin doser and injecting insulin Why does no insulin appear when try to prime the InDuo insulin doser 84 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE The needle may be blocked Change the needle and prime the InDuo insulin doser until insulin appears at the needle tip Check that the push button is pressed completely in and locked Open the slide and make sure that PenFill is inserted correctly If PenFill is damaged or empty change it Check that the slide
23. e blood glucose test results over 14 days and 30 days e The meter provides 2 averages of your blood glucose tests e The first average is calculated from tests performed over the last 2 weeks 14 days e The second average is calculated from tests performed over the last month 30 days e The meter ignores control solution test results when properly marked as control tests and uses only blood glucose test results to calculate these averages e The meter also tells you how many blood glucose tests were performed and therefore used to calculate the average For example if you see Hr on the meter display this means 64 tests were performed e When the meter is used for the first time you will see iHay and J302 showing that there are no test results stored yet in the meter memory 54 USING THE InDuo MEMORY FUNCTIONS Example Checking your previous injection Pull out the InDuo insulin doser After the display test see page 80 your previous dose or priming and the time passed since delivery can be seen on the insulin doser display Each segment represents 1 hour For example if 4 segments are displayed 3 4 hours have passed since the previous injection If 12 segments are displayed 3 12 hours or more have passed Always replace the insulin doser into the meter cap VIEWING BLOOD GLUCOSE TEST RESULTS ON APC 55 N VIEWING BLOOD GLUCOSE TEST RESULT
24. e direction of the arrow shown below The insulin doser display now shows Novo Nordisk GETTING YOUR InDuo SYSTEM READY FOR USE 23 k e Insert PenFill into the InDuo insulin doser by RN pushing it slightly backwards as shown The end te with the rear rubber stopper goes in first Make E sure that the threaded plastic cap fits firmly into place 68 e Close the slide completely The release button is locked until the slide has been closed e You should keep the slide closed until PenFill is empty and must be changed 24 GETTING YOUR InDuo SYSTEM READY FOR USE How to attach a NovoFine needle e Never place a NovoFine needle on your InDuo insulin doser until you are ready to prime your InDuo insulin doser by doing an air shot before giving an injection Wipe the front rubber stopper of the PenFill with an alcohol swab Take the protective tab off a NovoFine needle Screw the NovoFine needle tightly onto the threaded plastic cap Pull off the outer and inner needle caps before priming the InDuo insulin doser by doing an air shot How to prime the InDuo insulin doser by doing an air shot Priming the InDuo insulin doser is a method of making sure that the insulin is ready to flow when you make your injection Otherwise you will not receive the full insulin dose You will know that the InDuo insulin doser has been primed whe
25. e error message appears again call InDuo Customer Services at 1 877 520 9056 OneTouch Ultra test strip Refer to page 16 for control solution application and page 37 38 for blood application for proper time Check the OneTouch Ultra test strip for damage Refer to page 34 and 38 for proper sample application Repeat the test If the error message appears again call InDuo Customer Services at 1 877 520 9056 Meter display the InDuo meter has detected a problem with the test Possible causes are incompletely filled confirmation window or a damaged OneTouch Ultra test strip The battery symbol appears on the display with the unit of measure It means that the power of the battery is getting low You can complete about 50 more tests from the time this symbol first appears Action OneTouch Ultra test strip Refer to page 34 and 37 for proper sample application procedure If the error message appears again call InDuo Customer Services at 1 877 520 9056 Test results will still be accurate but replace the battery as soon as possible The battery symbol appears on the display by itself The power of the battery is too low to run a test Replace the battery immediately The Induo meter will not operate until the battery is replaced DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 77 Meter display What it means The InDuo meter has detected that the temperature is be
26. e the time passed since delivery 1 segment represents 1 hour Circle Confirms that the delivery has been completed Dose Shows the number of insulin units dialed InDuo COMPONENTS OneTouch Ul traSoft Adjustable blood sampler OneTouch Release button Cap OneTouch La Protective d LX ONETOUCH UltraSoft isk Ejection Cocking control Ultra Test strip Deep puncture Indicator mark Top edge Puncture depth setting knob Confirmation window Shallow puncture Contact bars NovoFine 6 mm or 8 mm Outer needle cap Inner needle cap Needle Protective tab PenFill 3 mL Front rubber stopper White bar code band f Rear rubber stopper Threaded Glass ball plastic cap for insulin suspensions only CONTENTS 4 WELCOME You have chosen the InDuo system a system designed to simplify the way you manage your diabetes Featuring an integrated blood glucose meter and insulin doser InDuo will enable you to check your blood glucose levels and administer insulin using one compact system This manual contains instructions for using storing and looking after your InDuo system Read it carefully Your InDuo meter provides you with accurate plasma calibrated test results This feature makes it easier for you and your doctor to compare your meter results with laborator
27. fferent puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses Position the Sampler e Hold the OneTouch UltraSoft Sampler firmly against the side of your finger e Press the release button Massage the Fingertip Massaging the fingertip gently will help you obtain a round drop of blood The blood sample must be at least 1 microliter in volume actual size to fill the confirmation window or you may get an F 5 message see page 40 or possibly an inaccurate test result Do not smear the blood sample Procee with your blood glucose test TESTING YOUR BLOOD GLUCOSE LEVELS 33 ZT gt Important information about arm testing e Under certain conditions blood glucose test results obtained using samples taken from your arm may differ significantly from fingertip samples e The conditions in which these differences are more likely to occur are when your blood glucose is changing rapidly such as following a meal an insulin dose or associated with physical exercise e When blood glucose is changing rapidly fingertip samples show these changes more quickly than arm samples e When your blood glucose is falling testing with a fingertip sample may identify a hypoglycemic low blood sugar level sooner than a test with an arm sample e Use arm samples only for testing prior to or more than 2 hours after meals ins
28. ge 42 Check to see if PenFill is damaged Dial back to zero and press the push button completely in until it locks Then open the slide and change PenFill as described on page 49 Prime the InDuo insulin doser until insulin appears at the needle tip see page 24 Please note that part of the insulin dose may have been injected If the push button still cannot be pressed completely in call InDuo Customer Services at 1 877 520 9056 Why does the slide not open when changing PenFill Put on a new needle Press the push button completely in until it locks Remove the needle and open the slide If the slide still cannot be opened call InDuo Customer Services at 1 877 520 9056 Do not try to force the slide open SPECIFICATIONS InDuo system Two minutes after last user action However the meter will allow for testing at temperatures up to 111 F 44 C WARRANTY The manufacturers warrant that the InDuo device shall be free of defects in material and workmanship for a period of three years Should your InDuo device be defective in materials or workmanship within three years of purchase the manufacturers will replace it at no charge No other warranty is made with respect to InDuo This warranty is valid from date of purchase The warranty extends only to the original purchaser and is not transferable This warranty will become invalid and the manufacturers assume no resp
29. ing a new PenFill start with units e Hold the InDuo insulin doser with the needle upwards and tap the slide gently with your finger a few times Press the push button completely in until it locks e A drop of insulin should appear at the needle tip If not repeat the priming procedure until a drop of insulin appears If you had opened the slide and your PenFill is not new you may need to repeat the procedure several times 2 5 H Please be aware that priming is not finished until a drop of insulin appears INJECTING YOUR INSULIN 43 How to dial your dose e Make sure that a NovoFine needle is attached and that the push button is pressed completely in e Press the release button and the push button will jump out The display will show Q e Dial the number of units you need by turning the dose selector at a steady speed In the example below a dose of 10 units has been dialed Novo Nordisk 44 INJECTING YOUR INSULIN How to change a dose dialed e If you accidentally dial a larger dose than you need dial back to the correct number of units Q e The dose dialed can be changed until you press the push button How to cancel a dose dialed e If you want to cancel a dose dialled dial back to 0 and press the push button completely in e Your last delivered dose or priming and the time passed since its delivery will reappear on the display e Begin again wi
30. irt and dust with a dry soft brush or cloth Use a cloth dampened with water and mild detergent to wipe down the outside of the meter Do not soak wash or lubricate the InDuo system This will damage the mechanism InDuo system will be damaged if wiped with alcohol CARING FOR YOUR InDuo SYSTEM 61 Power supply The InDuo system is powered by batteries making it portable and self contained The InDuo system comes with two battery systems already installed e The meter battery provides you with enough power to perform approximately 1000 blood glucose or control solution tests When the meter battery expires it is easily replaced using a 3 0 V 2032 or equivalent lithium battery Replaceable battery e The insulin doser battery cannot be replaced and has an extended life allowing it to operate for about 4 years When the insulin doser battery is due to expire the insulin doser display will begin flashing see page 64 and your InDuo insulin doser should then be replaced within 30 days Non replaceable battery 62 CARING FOR YOUR InDuo SYSTEM g When to change your InDuo meter battery Your InDuo meter will alert you when the power is getting low by displaying the following messages Q This message appears when the meter display is turned on and all the other display messages are functional It is time to change the meter battery From the time you see the batter
31. is closed and prime the InDuo insulin doser until insulin appears at the needle tip Why does no insulin appear when prime the InDuo insulin doser and the push button will not go in The needle may be blocked Change the needle and prime the InDuo insulin doser until insulin appears at the needle tip To open the slide dial back to zero 0 and press the push button completely in until it locks Then change PenFill as described on page 49 Why does the push button not release Make sure that the slide is closed completely The release button is locked until the slide is closed How do cancel or change the dialed dose Dial back to zero and press the push button completely in Your last dose and the time passed since delivery will reappear on the display You can increase decrease or cancel the dialed dose until you press the push button Do not change the dose after you have pressed the push button DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 85 Why is insulin delivered when the dose selector is turned You have dialed the maximum dose of 70 units and then continued dialing If you need to inject a dose of insulin larger than 70 units you must divide the dose into amounts equal to or less than 70 units Why does the push button block during the injection Do not try to force the push button in The needle may be blocked Change the needle and prime the InDuo doser as described on pa
32. ll return you to the 12 hour format Setting the year Before setting the date you must first set the time e With the preferred time format on the display press and the year digits will start flashing e Press and release until the correct year is displayed e To scroll faster hold down 8 GETTING YOUR InDuo SYSTEM READY FOR USE 4 Setting the month e Press and the date will appear on the display with the month display flashing e Press and release until the correct month is displayed e To scroll faster hold down Setting the day e Press and the day setting will start flashing e Press and release until the correct day is displayed e To scroll faster hold down GETTING YOUR InDuo SYSTEM READY FOR USE 9 Selecting the unit of measurement e With the correct day on the display press and the current unit of measurement will start flashing The InDuo meter can display test results in milligrams per deciliter mg dL or in millimoles per liter mmol L The mg dL unit is standard in the United States The mmol L unit is commonly used in Canada and some European countries e Consult your healthcare professional before you change the unit of measure e If the units are incorrect or have been changed press to select the correct units If the units are correct just press the button to exit the setting mode 1 10 GETTING YOUR InDuo SYSTEM READY FOR USE
33. low the arrow marks on the slide as shown in the picture The glass ball must have adequate space to resuspend the insulin In this situation you must change PenFill e The InDuo insulin doser will not let you dial a larger dose than that remaining in PenFill A Do not force the dose selector to turn instead change PenFill If you need more insulin than the amount left in PenFill you need to INJECTING YOUR INSULIN 47 48 INJECTING YOUR INSULIN a either e Change PenFill see page 49 e Prime the InDuo insulin doser see page 24 e Inject the whole dose at once or e Inject the remaining insulin making a note of the amount of insulin you have injected e Insert a new PenFill for the rest of your dose see page 47 e Prime the insulin doser see page 24 e Dial the remaining number of units to complete your dose e Inject making sure that you have now injected your full dose e If you have changed PenFill so that your total dose was divided into 2 doses note that the insulin doser memory will only remember the second of the 2 doses given INJECTING YOUR INSULIN 49 How to change PenFill e Make sure that the push button is pressed in completely Make sure there is no needle on the insulin doser Open the slide Take out the used PenFill Take a new PenFill and continue as described from page 21 Novo Nordisk
34. low the operating range You cannot perform a test until the InDuo meter and the OneTouch Ultra test strips reach a temperature within the operating range of 43 111 F 6 44 C Action Repeat the test after the InDuo meter and OneTouch Ultra test strips have reached a temperature within the operating range The InDuo meter has detected that the temperature is above the operating range You cannot perform a test until the InDuo meter and the OneTouch Ultra test strips reach a temperature within the operating range of 43 111 F 6 44 C Repeat the test after the InDuo meter and OneTouch Ultra test strips have reached a temperature within the operating range Here are the answers to some questions you might ask when using your InDuo meter What should do if the InDuo meter does not display a message after a OneTouch Ultra test strip has been inserted Probable reasons Action Battery exhausted Replace the battery Battery incorrectly installed or Check that the battery is correctly installed absent with the positive side up OneTouch Ultra test strip partially Insert the OneTouch Ultra test strip inserted or inserted upside down correctly with the contact bars end first and facing up Push the strip in firmly until it will go no further Defective meter Call InDuo Customer Services at 1 877 520 9056 What should do if the InDuo meter does no
35. n a drop of insulin appears at the tip of the NovoFine needle ySIPAON OAON GETTING YOUR InDuo SYSTEM READY FOR USE 25 N A The InDuo insulin doser should always be primed e Before each injection e After changing PenFill e After changing the NovoFine needle e After opening and closing the slide on the InDuo insulin doser Priming your InDuo insulin doser for the first time Z N Make sure that a NovoFine needle is attached the push button is pressed completely in and the slide is closed If the slide is not closed the _4 release button will be locked Novo Nordisk e Press the release button Q You will see that the push button jumps out E 26 GETTING YOUR InDuo SYSTEM READY FOR USE 9 Dial 8 units 6 e Hold the InDuo insulin doser with the NovoFine M needle upwards and tap the slide gently with your M finger a few times to ensure that any air in PenFill rises to the top i e Press the push button completely in until it locks e A drop of insulin should appear at the needle tip If the drop of insulin does not appear repeat the priming procedure dialing 1 unit at a time until a drop of insulin appears YSIPION OAON e If not injecting immediately discard the NovoFine needle safely e If you are injecting immediately the NovoFine needle will remain on the insulin doser until you have completed the injection Following your
36. ntrol solution test should be used to e check that your meter and OneTouch Ultra test strips are working together properly e check that you are performing the test correctly e practice testing your blood The control solution test should be done e at least once a week e when you begin using a new vial of OneTouch Ultra test strips if you suspect that your InDuo meter or OneTouch Ultra test strips are not working properly e when your blood glucose test results are not consistent with how you feel or when you think your results are not accurate e if you drop your InDuo meter Control Solution 5 arz pr GETTING YOUR InDuo SYSTEM READY FOR USE 15 N A Caution e Use only OneTouch Ultra Control Solution e Check the expiration date on the control solution vial Do not use if expired e Store control solution tightly closed at temperatures below 86 F 30 C e Do not refrigerate control solution e The control solution the InDuo meter and the OneTouch Ultra test strips should be at room temperature 68 77 F 20 25 C before testing e Shake the vial discard the first drop of control solution and wipe off the dispenser tip with a clean tissue to obtain a good sample and an accurate result e Use only for 3 months after the first opening Record the discard date date opened plus 3 months on the control solution vial Discard after 3 months e The control solution range
37. o test result stored in this No action required place in the InDuo memory 74 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE g Meter display mg dL Hive BHn Example ho mg dL J0 we 78 Example E EJ i What it means Average of the last 14 days 8 means that 64 tests were performed within this period Average of the last 30 days Hm means that 138 tests were performed during this period Error message that indicates that there is a problem with the InDuo meter Action No action required No action required Do not use the InDuo meter Call InDuo Customer Services at 1 877 520 9056 for replacement DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 75 Meter display J er What it means Error message could be caused by a used or damaged OneTouch Ultra test strip or there is a problem with the meter Error message that indicates that the blood sample or control solution was applied before appeared on the display Error message that indicates that there may be a problem with the test e g the OneTouch Ultra test strip may have been damaged or moved during testing or the sample has been improperly applied Repeat the test with a new to apply sample Action Repeat the test with a new OneTouch Ultra test strip Refer to page 10 for OneTouch Ultra test strip information If th
38. oid getting hand lotion oils dirt or debris on the lancets or on the meter TESTING YOUR BLOOD GLUCOSE LEVELS 29 Obtaining a drop of blood Insert a lancet in the blood sampler e Twist the cap of the blood sampler counter clockwise to remove it e Insert a new lancet into the lancet holder and Q push down firmly until it is fully seated Do not twist the lancet e Twist the protective disk until it separates from the lancet 65 30 TESTING YOUR BLOOD GLUCOSE LEVELS e Replace the cap e Turn the cap clockwise until it fits snugly but not too tight e Adjust puncture depth setting if necessary Twist the knob toward the smaller bumps for a shallower puncture or toward the larger bumps for a deeper puncture TESTING YOUR BLOOD GLUCOSE LEVELS 31 Cock the blood sampler e Slide the ejection cocking control back until it clicks e If it does not click the blood sampler may have been cocked when the lancet was inserted Wash your hands and the puncture site e Use warm soapy water to wash your hands and the puncture site e Rinse and dry thoroughly 32 TESTING YOUR BLOOD GLUCOSE LEVELS g Getting a Fingertip Blood Sample The InDuo System requires a very small blood drop to perform a test You may obtain it from a fingertip or arm See page 33 for information on obtaining a blood sample from the arm Choose a di
39. ond countdown The meter No action required is calculating the result At the end of the countdown the meter will display the test result A blood glucose test result in No action required mg dL mg dL Bee eee Example 2 A blood glucose test result in No action required 5 D mmol L 162 Example 72 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE g Meter display ketones pa i fie Ms ee Example mg dL Lo 8 What it means A blood glucose test result with a suggestion to check your ketone levels Indicates that you may have a very high blood glucose level possibly exceeding 600 mg dL 33 3 mmol L Indicates that you may have a very low blood glucose level possibly lower than 20 mg dL 1 1 mmol L Action You may want to check your ketone levels Act according to the instructions of your healthcare professional You should recheck your blood glucose level and if call your healthcare professional immediately You should treat this condition according to the recommendations of your healthcare professional Meter display What it means Action A blood glucose test result stored No action required in the memory 18 mg dL Meig Example A control solution test result stored No action required gn in the memory mg dL Be le 6 Example There is n
40. onsibility in the case of defects or damages arising from 1 the use of InDuo with products other than those specifically recommended by the manufacturers 2 the use of InNDuo in a manner other than in strict accordance with the instructions in this User s Manual or other instructions issued by the manufacturers and 3 physical damage to InDuo caused by neglect misuse unauthorized repair accident or other breakage BLOOD VALUE TARGETS Times of day Glucose ranges for people Your target ranges mg dL without diabetes mg dL Source Krall L P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 For assistance or further information please call InDuo Customer Services at our toll free number English 1 877 520 9056 Espanol 1 800 381 7226 Distributed by LifeScan Inc Milpitas California 95035 U S A In partnership with Novo Nordisk A S 2880 Bagsvaerd Denmark LifeScan Novo Nordisk 2001 Revision date August 2004 AW 06084101C
41. ot use OneTouch Ultra test strips beyond the expiration date printed on the package since using expired OneTouch Ultra test strips may produce inaccurate results e Do not bend cut or alter a OneTouch Ultra test strip in any way WARNING Keep the test strip vial away from children the cap is a choking hazard Also the cap may contain a pouch filled with drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation OneTouch Ultra test strips are single use Do not re use a test strip that has had sample applied to it Refer to your OneTouch Ultra test strip insert for additional information 12 GETTING YOUR InDuo SYSTEM READY FOR USE a Coding your InDuo meter Code numbers are used to calibrate the OneTouch Ultra test strips with the InDuo meter You must code the InDuo meter before using it for the first time and then every time you change to another vial of OneTouch Ultra test strips Each time you do a blood glucose test check that the code number on the meter display matches the code number on the OneTouch Ultra test strip vial CAUTION If the code numbers do not match your blood glucose tests may be inaccurate Entering the code mode e Start with the InDuo meter turned off e Insert a OneTouch Ultra test strip to turn on the meter Push the test strip in until it will go no further e All segments of the meter display will ap
42. pear When you first use the InDuo meter 3 dashes will appear showing there is no code stored in the meter memory GETTING YOUR InDuo SYSTEM READY FOR USE 13 Match the code numbers Example The calibration code is stored in the meter memory until you change it The current code number will appear on the display for 3 seconds e Compare the code number on the meter display with the code number on the OneTouch Ultra test strip vial e If the 2 code numbers match you may begin testing e the code numbers do not match follow the next procedure to recode the InDuo meter Code the InDuo meter e Press to select the correct code e Each time you press and release E the number on the display will increase by one To scroll faster hold down After you have selected the correct code number it will flash for 3 seconds and then appear solid for 3 seconds The apply symbol amp will appear with the units of measurement mg dL or mmol L indicating that the InDuo meter is ready for testing 14 GETTING YOUR InDuo SYSTEM READY FOR USE The control solution test OneTouch Ultra Control Solution is used to check that the meter and the OneTouch Ultra test strips are working together as a system and that you are performing the test correctly It is very important that you do this simple test routinely to check that the system is providing accurate results The co
43. r as described on page 24 When the insulin doser is removed from the meter cap all the display segments are turned on telling you that the display is fully functional display test No action required Message What it means Action The display shows the number of No action required insulin units dialed The segments turning on two by two No action required tell you how long to leave the needle under the skin during injection The display shows the number of No action required insulin units delivered The circle confirms that the delivery has been completed 82 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE y Message What it means Action aN The display shows the number of insulin No action required units delivered The segments indicate i the time passed since delivery 1 segment m represents 1 hour In this example 4 hours have passed since the insulin doser delivered the previous dose N A flashing display indicates that the Be sure to replace your a a battery power is low insulin doser within 30 days wey The battery in the insulin 7 In doser cannot be changed Call InDuo Customer Services at 1 877 520 9056 to get a new insulin doser A minus symbol on the display tells Dial forward until the you that the dose selector has been display shows the number dialed below zero 0 of units required DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 83 Here ar
44. r to recode the meter Call InDuo Customer Services at 1 877 520 9056 Check that the meter is coded correctly GETTING YOUR InDuo SYSTEM READY FOR USE 21 A PREPARING YOUR InDuo INSULIN DOSER TO INJECT INSULIN Before you are ready to inject your insulin the InDuo insulin doser must be loaded with a PenFill insulin cartridge A needle must be attached and the InDuo insulin doser must be primed by doing an air shot How to load your PenFill e Before loading PenFill read the Information For The Patient that accompanies it carefully In the Information For The Patient you will find instructions on how to e Check that the PenFill is full and intact If not do not use it e Resuspend the insulin if PenFill contains an insulin suspension cloudy insulin A Use only a new PenFill when loading the InDuo insulin doser Never load a partially filled PenFill A Each PenFill is for single person use only Do not use the same PenFill for more than one person even though you attach a new NovoFine needle for each injection 22 GETTING YOUR InDuo SYSTEM READY FOR USE g To load PenFill e Pull out the InDuo insulin doser e The very first time the insulin doser is pulled out the insulin doser display stays blank until the slide is opened e Make sure that the push button is pressed completely in Otherwise the slide will remain locked e Open the slide in th
45. t start running the blood glucose test after the OneTouch Ultra test strip has been inserted Probable reasons Defective OneTouch Ultra test strip Sample applied after automatic shut off 2 minutes after last used Action Repeat the test with a new OneTouch Ultra test strip and a larger sample Repeat the test with a new OneTouch Ultra test strip Repeat the test with a new OneTouch Ultra test strip apply sample only when the apply symbol amp appears on the display Call InDuo Customer Services at 1 877 520 9056 80 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE g The InDuo insulin doser As with the meter display a number of messages and symbols appear on the InDuo insulin doser display during use of the insulin doser Message What it means Action The very first time the insulin doser is removed from the meter cap the display stays blank until the slide is opened However if the display goes off having already come on carry out the correction measures described in the next column If the display still remains off the insulin doser is not working Do not use the insulin doser Call InDuo Customer Services at 1 877 520 9056 If the display goes off press the release button and the push button will jump out Press the push button completely in and the display should reappear If the display does not reappear open and close the slide Prime the InDuo insulin dose
46. th How to dial your dose See page 43 Novo Nordisk How to give an injection It is important that you follow the injection method recommended by your healthcare professional To inject press the push button completely in until it locks You will probably feel that the push button becomes a little harder to press at the end of the injection This is normal A Do not change the dose after you have pressed the push button e With all insulin injection systems the needle should be left under the skin for at least 6 seconds to ensure that the full insulin dose has been delivered The InDuo insulin doser helps you to do this by providing a built in timer INJECTING YOUR INSULIN 45 46 INJECTING YOUR INSULIN g o e When the push button is pressed completely in the segments turn on two by two telling you to leave the needle under your skin e When the circle symbol appears the full insulin dose has been delivered and you can withdraw the needle After the injection follow the instructions of your health care professional to e Carefully replace the outer needle cap on the needle e Unscrew the needle and discard it properly e Always replace the insulin doser into the meter cap What to do when PenfFill is nearly empty e Do not try to inject an insulin suspension cloudy insulin if the rear rubber stopper is be
47. time date and unit of measurement However you can reset these if you need to change the date or time or if you remove the meter battery Since the InDuo meter also gives average values 14 days and 30 days for your blood glucose tests see page 53 you may find that changing the date and time will also alter the values for the 14 day and 30 day averages To set the time date and unit of measurement you must first enter the setting mode on the InDuo meter display Enter the setting mode e Press and hold down J for 3 seconds e The InDuo meter is now in the setting mode and you are ready to change the time using the meter display a Setting the hour e The time will appear first with the hour digits flashing e Press and release until the correct hour is displayed e To scroll faster hold down e After setting the hour press W to set the minutes The minutes digits will start flashing Setting the minutes e Press and release until the correct minute is displayed e To scroll faster hold down GETTING YOUR InDuo SYSTEM READY FOR USE 7 Setting the time format e Press and the 12 hour format will start flashing e Your InDuo meter can display the time in either a 12 hour format 4 or a 24 hour format AOA to 2454 e The 12 hour format is pre set in the meter e If you wish to display the time in 24 hour format press and release K Pressing again wi
48. ulin dose or physical exercise e Testing performed within 2 hours after meals an insulin dose or physical exercise or whenever you feel that your glucose levels may be changing rapidly should be done from the fingertip e You should also use fingertip testing whenever you have a concern about hypoglycemia insulin reactions such as when driving a car particularly if you suffer from hypoglycemic unawareness lack of symptoms to indicate an insulin reaction as arm testing may fail to detect hypoglycemia What you should do e Use arm or fingertip samples for testing prior to or more than two hours after meals insulin dose or physical exercise e Routine testing before meals can be done either at the fingertip or the arm e Consult your healthcare professional before you begin using the arm for testing 34 TESTING YOUR BLOOD GLUCOSE LEVELS Actual size of required blood volume rounded drop O XR 1 Incorrect lt 7 Getting a Blood Sample From The Arm The arm has fewer nerve endings than the fingertip so you may find that obtaining a blood sample from the arm may be much less painful than using the fingertip The technique for obtaining a blood drop from the arm is different from fingertip sampling Also there are differences between arm samples and fingertip samples that you should understand Please read Important information about
49. vailable from InDuo Customer Services Please call our toll free number at 1 877 520 9056 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 69 The InDuo meter Here is a summary of the different messages given on the InDuo meter display Meter display Bg mmol L mg d HGH ave DEBE sm code What it means This indicates that the meter is running a system check It appears whenever a OneTouch Ultra test strip is inserted and when the InDuo blood glucose meter is turned on It verifies that all segments on the display are working This message appears immediately after the system check if your meter has not been coded Action If segments are missing call InDuo Customer Services at 1 877 520 9056 for further action Missing segments can lead to the wrong interpretation of the displayed test result See Coding your InDuo meter on page 12 Meter display What it means This is the code number stored in the InDuo meter 2 Example The system is ready to accept a blood sample The system is ready to accept a control solution test sample Action Make sure that this code number matches the code number on the vial of the OneTouch Ultra test strips you are using If not you must recode the meter see page 11 You may now apply the blood sample You may now apply the control solution Meter display What it means Action Five sec
50. y results If you have been using another type of meter you may notice that the results with the InDuo meter are about 12 higher than with your previous system The InDuo meter is designed for use with OneTouch Ultra test strips only Your InDuo insulin doser provides you with state of the art insulin delivery including a memory to tell you how much you injected and how long ago you made your injection By combining meter and insulin doser into one the InDuo system helps you simplify your insulin therapy and increase your confidence in managing your diabetes A warranty registration card is included with your InDuo system If you complete it and mail it to us we will send you a gift We are sure that you will find your InDuo system simple and easy to use If you have any questions regarding your InDuo system please do not hesitate to call InDuo Customer Services at our toll free number 1 877 520 9056 The InDuo meter is intended for use outside the body in vitro diagnostic use It should be used only for testing glucose sugar and only with fresh capillary whole blood samples It should not be used for the diagnosis of diabetes or for the testing of newborns GETTING YOUR InDuo SYSTEM READY FOR USE 5 GETTING YOUR InDuo SYSTEM READY FOR USE Preparing your InDuo meter Setting the time date and unit of measurement Your InDuo meter comes with pre set values for the
51. y symbol change the battery as soon as possible There is enough power left in the battery for about 50 tests The meter will not operate if the battery is allowed to expire This message means that the meter battery does not have enough power left for a test Change the battery immediately with one 3 0 V 2032 or equivalent lithium battery CARING FOR YOUR InDuo SYSTEM 63 How to replace the InDuo meter battery To replace the meter battery make sure that the InDuo meter is turned off Turn your InDuo meter over and locate the battery compartment Open the battery door on the back of the meter Q Remove the old battery Insert one 3 0 V 2032 or equivalent lithium battery making sure the positive side of the battery is facing up Slide the battery door closed Replacing the meter battery does not affect test results already stored in the InDuo memory However the time date and unit of measurement settings may need to be updated See page 5 The first time you turn on the InDuo meter after replacing the battery the meter display may go into the setting mode automatically At this time you should update the time date and unit of measurement settings eau HONOLINO en HONOLINO 64 CARING FOR YOUR InDuo SYSTEM Example When to replace your InDuo insulin doser A flashing display indicates that the insulin doser battery power is low e Be
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