Lifescan InDuo blood glucose meter manuale d’uso

InDuo ™ Blood Glucose Meter InDuo™ SYSTEM AND ACCESSORIES OneT ouch ® Ultra T est Strips OneT ouch ® Ultra Control Solution InDuo ™ Insulin Doser NovoFine ® Needles 10-pack PenFill ® 3 mL Insulin Cartridge OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® UltraSoft™ Sterile Lancet OneT ouch ® UltraClear ™ cap for altern[...]

InDuo ™ Blood Glucose Meter InDuo™ SYSTEM AND ACCESSORIES OneT ouch ® Ultra T est Strips OneT ouch ® Ultra Control Solution InDuo ™ Insulin Doser NovoFine ® Needles 10-pack PenFill ® 3 mL Insulin Cartridge OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® UltraSoft™ Sterile Lancet OneT ouch ® UltraClear ™ cap for altern[...]

InDuo ™ Blood Glucose Meter InDuo™ SYSTEM AND ACCESSORIES OneT ouch ® Ultra T est Strips OneT ouch ® Ultra Control Solution InDuo ™ Insulin Doser NovoFine ® Needles 10-pack PenFill ® 3 mL Insulin Cartridge OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® UltraSoft™ Sterile Lancet OneT ouch ® UltraClear ™ cap for altern[...]

NovoFine ® 6 mm or 8 mm OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® Ultra T est strip OneT ouch ® Lancet PenFill ® 3 mL Needle Protective tab Inner needle cap Threaded plastic cap Front rubber stopper White bar code band Rear rubber stopper Glass ball (for insulin suspensions only) Outer needle cap T op edge Confirmation wind[...]

NovoFine ® 6 mm or 8 mm OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® Ultra T est strip OneT ouch ® Lancet PenFill ® 3 mL Needle Protective tab Inner needle cap Threaded plastic cap Front rubber stopper White bar code band Rear rubber stopper Glass ball (for insulin suspensions only) Outer needle cap T op edge Confirmation wind[...]

NovoFine ® 6 mm or 8 mm OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® Ultra T est strip OneT ouch ® Lancet PenFill ® 3 mL Needle Protective tab Inner needle cap Threaded plastic cap Front rubber stopper White bar code band Rear rubber stopper Glass ball (for insulin suspensions only) Outer needle cap T op edge Confirmation wind[...]

3 CONTENTS Welcome 4 Getting your InDuo TM system ready for use 5 Preparing your InDuo TM meter 5 Preparing your InDuo TM insulin doser to inject insulin 21 T esting your blood glucose levels 27 Injecting your insulin 41 Using the InDuo TM memory functions 51 Checking your previous test results 51 Checking your previous injection 54 Viewing blood g[...]

4 WELCOME Y ou have chosen the InDuo TM system, a system designed to simplify the way you manage your diabetes. Featuring an integrated blood glucose meter and insulin doser , InDuo TM 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[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 5 GETTING YOUR InDuo TM SYSTEM READY FOR USE Preparing your InDuo TM meter Setting the time, date, and unit of measurement Y our InDuo TM meter comes with pre-set values for the 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 m[...]

Setting the hour • The time will appear first, with the hour digits flashing. • Press and release Ñ until the correct hour is displayed. • T o scroll faster , hold Ñ down. • After setting the hour , press ˛ to set the minutes. The minutes digits will start flashing. Setting the minutes • Press and release Ñ until the correct minute is[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 7 Setting the time format • Press ˛ and the 12-hour format will start flashing. • Y our InDuo TM meter can display the time in either a 12-hour format ¸ or a 24-hour format | to ‹ . • The 12-hour format is pre-set in the meter . • If you wish to display the time in 24-hour format, press and rel[...]

8 GETTING YOUR InDuo TM SYSTEM READY FOR USE Setting the month • Press ˛ and the date will appear on the display with the month display flashing. • Press and release Ñ until the correct month is displayed. • T o scroll faster , hold Ñ down. Setting the day • Press ˛ and the day setting will start flashing. • Press and release Ñ until[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 9 Selecting the unit of measurement • With the correct day on the display , press ˛ and the current unit of measur ement will start flashing. The InDuo TM meter can display test results in milligrams per deciliter ( Á ) or in millimoles per liter ( fi ). The Á unit is standard in the United States. T[...]

10 GETTING YOUR InDuo TM SYSTEM READY FOR USE æ OneT ouch ® Ultra test strips Y our InDuo TM meter is designed for use with OneT ouch ® Ultra test strips only . • Store the OneT ouch ® Ultra test strip package in a cool, dry place below 30°C (86ºF). Keep away from direct sunlight and heat. Do not refrigerate. • Store your OneT ouch ® Ult[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 11 • Apply only control solution or a blood sample to the top edge of the OneT ouch ® Ultra test strip. Applying other substances to the top edge may cause inaccurate results. • Do not use OneT ouch ® Ultra test strips beyond the expiration date printed on the package since using expired OneT ouch ®[...]

(Example) 12 GETTING YOUR InDuo TM SYSTEM READY FOR USE Coding your InDuo TM meter Code numbers are used to calibrate the OneT ouch ® Ultra test strips wi t h t h e I nDuo TM meter . Y ou must code the InDuo TM meter before using it for the first time, and then every time you change to another vial of OneT ouch ® Ultra test strips. Each time you [...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 13 Match the code numbers 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. • Compare the code number on the meter display with the code number on the OneT ouch ® Ultra test strip vial . • If the 2 code numbers mat[...]

14 GETTING YOUR InDuo TM SYSTEM READY FOR USE The control solution test OneT ouch ® Ultra Control Solution is used to check that the meter and the OneT ouch ® 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 p[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 15 æ Caution • Use only OneT ouch ® Ultra Control Solution • Check the expiration date on the control solution vial. Do not use if expired. • Store control solution tightly closed at temperatures below 86ºF (30°C). • Do not refrigerate control solution. • The control solution, the InDuo TM me[...]

a 16 GETTING YOUR InDuo TM SYSTEM READY FOR USE Before you use your InDuo TM 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 OneT ouch ® Ultra test strip vial, you are ready to test your blood. How to do a control solu[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 17 • After the apply symbol R appears on the display , press Ñ . • The Ë symbol will appear on the display . With the Ë symbol on the display , the meter will mark your next test in the memory as a control solution test. If you decide not to perform a control solution test, press Ñ again and the Ë[...]

b c Apply control solution • Shake the control solution vial well. • Remove the cap. • 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 b to the top edge area of the OneT ouch ® Ultra test strip (where it m[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 19 æ Caution • If the control solution test r esult falls outside the range printed on the OneT ouch ® Ultra test strip vial, repeat the test. • If you continue to get control solution test r esults that fall outside of the range printed on the vial, the InDuo TM system may not be working properly . [...]

20 GETTING YOUR InDuo TM SYSTEM READY FOR USE The control solution test tr oubleshooting There are several reasons why a control solution test result may fall outside the expected range (as printed on the OneT ouch ® Ultra test strip vial label). Probable r easons Action Repeat the test, closely following the instructions on pages 16–18 Shake th[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 21 PREP ARING YOUR InDuo TM INSULIN DOSER TO INJECT INSULIN Before you are ready to inject your insulin, the InDuo TM insulin doser must be loaded with a PenFill ® insulin cartridge. A needle must be attached and the InDuo TM insulin doser must be primed by doing an air shot. How to load your PenFill ® ?[...]

c b a 22 GETTING YOUR InDuo TM SYSTEM READY FOR USE T o load PenFill ® : • Pull out the InDuo TM insulin doser a . • The very first time the insulin doser is pulled out, the insulin doser display stays blank until the slide is opened. • Make sure that the push button is pressed completely in b . Otherwise the slide will remain locked. • Op[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 23 f d • Insert PenFill ® into the InDuo TM insulin doser by pushing it slightly backwards as shown d . The end with the rear rubber stopper goes in first. Make sure that the threaded plastic cap fits firmly into place e . • Close the slide completely f . The release button is locked until the slide h[...]

How to attach a NovoFine ® needle • Never place a NovoFine ® needle on your InDuo TM insulin doser until you are ready to prime your InDuo TM insulin doser by doing an air shot before giving an injection. • Wipe the front rubber stopper of the PenFill ® with an alcohol swab. • T ake the protective tab off a NovoFine ® needle. • Screw th[...]

GETTING YOUR InDuo TM SYSTEM READY FOR USE 25 æ The InDuo TM insulin doser should always be primed: • Before each injection. • After changing PenFill ® . • After changing the NovoFine ® needle. • After opening and closing the slide on the InDuo TM insulin doser . Priming your InDuo TM insulin doser for the first time æ Make sure that a [...]

b d c 26 GETTING YOUR InDuo TM SYSTEM READY FOR USE • Dial 8 units b . • Hold the InDuo TM insulin doser with the NovoFine ® needle upwards and tap the slide gently with your finger a few times c , to ensure that any air in PenFill ® rises to the top. • Press the push button completely in until it locks d . • A drop of insulin should appe[...]

TESTING YOUR BLOOD GLUCOSE LEVELS 27 TESTING YOUR BLOOD GLUCOSE LEVELS Be sure to read this section, Important Information on page 65, and the OneT ouch ® Ultra test strip package insert found in this system kit box carefully before testing. Before using your InDuo TM meter to test your blood glucose level, check that you have all the items needed[...]

28 TESTING YOUR BLOOD GLUCOSE LEVELS Check that the InDuo TM meter display is working properly . Y ou will know the meter display is working properly because each time the InDuo TM meter is turned on, all the segments of the meter display appear briefly (see “InDuo TM meter and insulin doser display symbols” in cover flap). After checking that [...]

a TESTING YOUR BLOOD GLUCOSE LEVELS 29 Obtaining a drop of blood Insert a lancet in the blood sampler • T wist the cap of the blood sampler counter- clockwise to remove it. • Insert a new lancet into the lancet holder , and push down firmly until it is fully seated a . Do not twist the lancet. • T wist the protective disk until it separates f[...]

30 TESTING YOUR BLOOD GLUCOSE LEVELS O NE T OUCH UltraSoft c • Replace the cap c . • T urn the cap clockwise until it fits snugly but not too tight. • Adjust puncture depth setting if necessary . T wist the knob toward the smaller bumps for a shallower puncture or toward the larger bumps for a deeper puncture d . O NE T OUCH ® UltraSoft d DC[...]

O NE T OUCH ® UltraSoft TESTING YOUR BLOOD GLUCOSE LEVELS 31 f Cock the blood sampler • 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. W ash your hands and the puncture site • Use warm, soapy water to wash your hands and the puncture sit[...]

O U g 32 TESTING YOUR BLOOD GLUCOSE LEVELS O NE T OUCH ® UltraSoft Getting a Fingertip Blood Sample The InDuo TM System requires a very small blood drop to perform a test. Y ou may obtain it from a fingertip or arm. (See page 33 for information on obtaining a blood sample from the arm). Choose a different puncture site each time you test. Repeated[...]

TESTING YOUR BLOOD GLUCOSE LEVELS 33 Important information about arm testing • Under certain conditions, blood glucose test results obtained using samples taken from your arm may differ significantly fr om fingertip samples. • The conditions in which these differ ences are mor e likely to occur are when your blood glucose is changing rapidly su[...]

34 TESTING YOUR BLOOD GLUCOSE LEVELS 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 differenc[...]

TESTING YOUR BLOOD GLUCOSE LEVELS 35 h i 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 finge[...]

36 TESTING YOUR BLOOD GLUCOSE LEVELS Cleaning the OneT ouch ® UltraSoft TM blood sampler • Clean the sampler with soap and water as needed. T o 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 [...]

TESTING YOUR BLOOD GLUCOSE LEVELS 37 Incorrect Correct correctly . (See page 9 for additional information on the units of measurement.) • Code the meter if necessary . Apply blood sample • Obtain a rounded dr op of blood from your finger using the blood sampler . The blood sample must be at least 1 microliter in volume ( • actual size of roun[...]

Good sample Sample too small 38 TESTING YOUR BLOOD GLUCOSE LEVELS • 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 [...]

TESTING YOUR BLOOD GLUCOSE LEVELS 39 Read the results • Y our blood glucose test result will appear after the InDuo TM meter counts down from N to A . • T urn off the InDuo TM meter by removing the OneT ouch ® Ultra test strip. • Blood glucose test results are automatically stored in the InDuo TM meter memory . • The InDuo TM meter provide[...]

Special messages HI: If your blood glucose test result is above 600 mg/dL (33.3 mmol/L), S will appear on the meter display . This indicates severe hyperglycemia (high blood glucose). Y ou should re-check your glucose level, and if S call your health care pr ofessional immediately . When your blood glucose test result is above 240 mg/dL (13.3 mmol/[...]

INJECTING YOUR INSULIN 41 INJECTING YOUR INSULIN æ Before beginning, r ead Important Information on page 65. T o begin preparation for injecting your insulin, pull out the InDuo TM insulin doser . Do not press any buttons on the meter cap while you remove the insulin doser . Attach a NovoFine ® needle. Y ou will then be ready to prime your insuli[...]

c e f d b 42 INJECTING YOUR INSULIN How to prime your InDuo TM insulin doser • Make sure that a NovoFine ® needle is attached (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 b . Y ou will see that the push button jumps o[...]

b a How to dial your dose • Make sure that a NovoFine ® needle is attached and that the push button is pressed completely in. • Press the release button a and the push button will jump out. The display will show 0 . • Dial the number of units you need by turning the dose selector at a steady speed b . In the example below a dose of 10 units [...]

44 INJECTING YOUR INSULIN a How to change a dose dialed • If you accidentally dial a larger dose than you need, dial back to the correct number of units a . • The dose dialed can be changed until you press the push button. How to cancel a dose dialed • If you want to cancel a dose dialled, dial back to 0 and press the push button completely i[...]

INJECTING YOUR INSULIN 45 How to give an injection It is important that you follow the injection method recommended by your healthcare professional. T o inject, press the push button completely in until it locks a . Y ou will probably feel that the push button becomes a little harder to press at the end of the injection. This is normal. æ Do not c[...]

b c 46 INJECTING YOUR INSULIN • When the push button is pressed completely in, the segments turn on two by two “ telling you to leave the needle under your skin. • When the circle symbol § appears b , the full insulin dose has been delivered and you can withdraw the needle. After the injection follow the instructions of your health care prof[...]

INJECTING YOUR INSULIN 47 What to do when PenFill ® is nearly empty • Do not try to inject an insulin suspension (cloudy insulin) if the rear rubber stopper is below 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 ® . • The InDuo[...]

either • Change PenFill ® (see page 49). • Prime the InDuo TM insulin doser (see page 24). • Inject the whole dose at once. or • Inject the remaining insulin, making a note of the amount of insulin you have injected. • Insert a new PenFill ® for the rest of your dose (see page 47). • Prime the insulin doser (see page 24). • Dial the[...]

INJECTING YOUR INSULIN 49 How to change PenFill ® • Make sure that the push button is pressed in completely a . • Make sure there is no needle on the insulin doser . • Open the slide. • T ake out the used PenFill ® b . • T ake a new PenFill ® and continue as described from page 21. b a DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 49[...]

20 50 INJECTING YOUR INSULIN InDuo TM insulin doser function check Y ou should regularly check the functioning of your InDuo TM insulin doser . For example, once a month, or before starting a new box of PenFill ® cartridges. Y ou should also check the functioning of the InDuo TM insulin doser if you think that it is not working properly . • Scre[...]

USING THE InDuo TM MEMOR Y FUNCTIONS 51 USING THE InDuo TM MEMOR Y FUNCTIONS Both the InDuo TM meter and the InDuo TM insulin doser have memory functions. Checking your previous test r esults Y our InDuo TM 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[...]

(Example) 52 USING THE InDuo TM MEMOR Y FUNCTIONS How to recall test r esults • After 3 seconds, the 30-day average will be replaced by the most recent test result with date and time. • Press Ñ once and the next most recent test result will appear . • Each time you press and release Ñ , the meter will recall your last test results in order [...]

USING THE InDuo TM MEMOR Y FUNCTIONS 53 Other memory functions of the InDuo TM meter The InDuo TM meter can provide valuable information on variations in your blood glucose levels. A verage blood glucose test results over 14 days and 30 days • The meter provides 2 averages of your blood glucose tests. • The first average, † is calculated from[...]

54 USING THE InDuo TM MEMOR Y FUNCTIONS Checking your previous injection • Pull out the InDuo TM 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 £ , [...]

VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PC 55 VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PERSONAL COMPUTER Y ou 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 Ca[...]

56 VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PC How to transfer glucose test results to your PC Install IN TOUCH ® software • Install IN TOUCH ® software on your computer following the instructions provided in the IN TOUCH ® user’ s manual. Connect the LifeScan Interface Cable • Connect the LifeScan Interface Cable to a serial port on the b[...]

VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PC 57 • While the InDuo TM meter is in the communication mode, you cannot use the InDuo TM meter to perform a blood glucose test. Similarly , when the InDuo TM meter is in either the memory mode or the setting mode, it is unable to respond to computer commands. Data transfer to computer • Follow the inst[...]

58 COMP ARING THE InDuo TM METER AND LABORA TORY RESUL TS COMP ARING THE InDuo TM METER AND LABORA TOR Y RESUL TS The InDuo TM 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 re[...]

COMP ARING THE InDuo TM METER AND LABORA TORY RESUL TS 59 • Never use your InDuo TM meter with blood that has been collected in a grey-top blood collection tube. • Use fresh capillary blood only . Other reasons for variation Besides the factors listed in the OneT ouch ® Ultra test strip package insert there are other reasons for variations: ?[...]

CARING FOR YOUR InDuo TM SYSTEM • Y our InDuo TM is a precision instrument. T o ensure it works accurately and safely , handle it with care. • Avoid situations where your InDuo TM component parts can be damaged. • Store InDuo TM in its carrying case after each use. • Always replace the meter cap after using your InDuo TM insulin doser . •[...]

CARING FOR YOUR InDuo TM SYSTEM 61 Power supply The InDuo TM system is powered by batteries making it portable and self-contained. The InDuo TM system comes with two battery systems already installed. • The meter battery provides you with enough power to perform approximately 1000 blood glucose or control solution tests. When the meter battery ex[...]

62 CARING FOR YOUR InDuo TM SYSTEM When to change your InDuo TM meter battery Y our InDuo TM meter will alert you when the power is getting low by displaying the following messages. a 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[...]

CARING FOR YOUR InDuo TM SYSTEM 63 How to replace the InDuo TM meter battery • T o replace the meter battery , make sure that the InDuo TM meter is turned off. • T urn your InDuo TM meter over and locate the battery compartment. • Open the battery door on the back of the meter a . • Remove the old battery . Insert one 3.0 V (#2032 or equiva[...]

64 CARING FOR YOUR InDuo TM SYSTEM When to replace your InDuo TM insulin doser A flashing display indicates that the insulin doser battery power is low . • Be sure to replace your InDuo TM insulin doser within 30 days. The battery cannot be changed. Call InDuo TM Customer Services at 1-877-520-9056 to obtain a new InDuo TM insulin doser . (Exampl[...]

IMPORT ANT INFORMA TION 65 æ IMPORT ANT INFORMA TION • As a precautionary measure, always carry a spare insulin delivery system in case your InDuo TM doser is lost or damaged. • Always prime your InDuo TM insulin doser (see page 24) to ensure the insulin flow: • Before each injection. • After changing PenFill ® . • After changing the ne[...]

66 IMPORT ANT INFORMA TION • The InDuo TM system is tough but could still be damaged. Handle it with care, do not drop it, and avoid knocking it against hard surfaces. If the InDuo TM 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). • Never use [...]

IMPORT ANT INFORMA TION 67 • T ake the needle off the InDuo TM 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 sus[...]

68 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE There are a number of messages and symbols that appear on the insulin doser and meter displays during use of the InDuo TM system. The following is a summary of all display messages. The meter gives an error message when it detects a problem which could caus[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 69 The InDuo TM meter Here is a summary of the different messages given on the InDuo TM meter display . This indicates that the meter is running a system check. It appears whenever a OneT ouch ® Ultra test strip is i ns e rt e d a n d w h en t he InDuo TM blood glucose meter is turned on. It verifies th[...]

70 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE This is the code number stored in the InDuo TM meter . Make sure that this code number matches the code number on the vial of the OneT ouch ® Ultra test strips you are using. If not, you must recode the meter (see page 11). Meter display What it means Action The system is ready to accept a blood samp[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 71 Meter display What it means Action Five-second countdown. The meter is calculating the result. At the end of the countdown, the meter will display the test result. No action required. A blood glucose test result in mg/dL. No action required. A blood glucose test result in mmol/L. No action required. ([...]

72 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Meter display What it means Action A blood glucose test result with a suggestion to check your ketone levels. Y ou may want to check your ketone levels. Act according to the instructions of your healthcare professional Indicates that you may have a very high blood glucose level, possibly exceeding 600[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 73 Meter display What it means Action A blood glucose test result stored in the memory . No action required. A control solution test result stored in the memory . No action required. There is no test result stored in this place in the InDuo TM memory . No action required. (Example) (Example) DCO_06084101[...]

74 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Meter display What it means Action No action required. Average of the last 30 days. ( ∑ means that 138 tests were performed during this period). No action required. Error message that indicates that there is a problem with the InDuo TM meter . Do not use the InDuo TM meter . Call InDuo TM Customer S[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 75 Meter display What it means Action Error message could be caused by a used or damaged OneT ouch ® Ultra test strip, o r there is a problem with the meter . Repeat the test with a new OneT ouch ® Ultra test strip. Refer to page 1 0 for OneT ouch ® Ultra test strip information. If the error message a[...]

76 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Meter display What it means Action Error message that indicates that the InDuo TM meter has detected a problem with the test. Possible causes are incompletely filled confirmation window or a damaged OneT ouch ® Ultra test strip. Repeat the test with a new OneT ouch ® Ultra test strip. Refer to page [...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 77 Meter display What it means Action Repeat the test after the InDuo TM meter and OneT ouch ® Ultra test strips have reached a temperature within the operating range. The InDuo TM meter has detected that the temperature is above the operating range . Y ou cannot perform a test until the InDuo TM meter [...]

78 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Here ar e the answers to some questions you might ask when using your InDuo TM meter: What should I do if the InDuo TM meter does not display a message after a OneT ouch ® Ultra test strip has been inserted? Probable r easons Action Replace the battery . Check that the battery is correctly installed [...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 79 What should I do if the InDuo TM meter does not start running the blood glucose test after the OneT ouch ® Ultra test strip has been inserted? Probable r easons Action Repeat the test with a new OneT ouch ® Ultra test strip and a la r ger sample. Repeat the test with a new OneT ouch ® Ultra test st[...]

80 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE The InDuo TM insulin doser As with the meter display , a number of messages and symbols appear on the InDuo TM insulin doser display during use of the insulin doser . Message What it means Action If the display goes off, press the release button, and the push button will jump out. Press the push butto[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 81 The segments turning on two by two tell you how long to leave the needle under the skin during injection. No action required. The display shows the number of insulin units dialed. No action required. Message What it means Action The display shows the number of insulin units delivered. The circle confi[...]

82 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE The display shows the number of insulin units delivered. The segments indicate the time passed since delivery . 1 segment represents 1 hour . In this example 4 hours have passed since the insulin doser delivered the previous dose. No action required. Message What it means Action A minus symbol on the [...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 83 Here ar e answers to some questions you might ask about your InDuo TM 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 [...]

84 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE The needle may be blocked. Change the needle and prime the InDuo TM 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.[...]

DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 85 Why is insulin delivered when the dose selector is turned? Y ou 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 duri[...]

86 SPECIFICA TIONS InDuo TM system Size: 123 mm x 54 mm x 35 mm (4.84 in x 2.13 in x 1.38 in) Weight: 4.40 ounces with battery (125g) Operating ranges: T emperature: 43–104ºF (6–40°C)* Relative humidity: 10–90% Hematocrit: 30–55% InDuo TM meter Result range: 20-600 mg/dL (1.1–33.3 mmol/L) Calibration: Plasma-equivalent Blood sample: Fre[...]

87 InDuo TM doser Cartridge: 3mL PenFill ® Needle: NovoFine ® max 8 mm length Dose: 1 IU increment, minimum = 1 IU, maximum = 70 IU Memory: 1 (last dose and time since) Power source: Internal non-replaceable lithium battery Battery life: 4 years + 1 year of shelf life WARRANTY The manufacturers warrant that the InDuo TM device shall be free of de[...]

88 BLOOD V ALUE T ARGETS Times of day Glucose ranges for people Y our target ranges (mg/dL) without diabetes (mg/dL) Before br eakfast 70–105 Before lunch or dinner 70–110 1 hour after meals Less than 160 2 hours after meals Less than 120 Between 2 and 4 am Greater than 70 Source: Krall, L.P ., and Beaser , R.S.: Joslin Diabetes Manual , Philad[...]

DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 89[...]

DCO_06084101C_InDuo_OB_US 8/16/04 1:08 PM Page 90[...]

NovoFine ® 6 mm or 8 mm OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® Ultra T est strip OneT ouch ® Lancet PenFill ® 3 mL Needle Protective tab Inner needle cap Threaded plastic cap Front rubber stopper White bar code band Rear rubber stopper Glass ball (for insulin suspensions only) Outer needle cap T op edge Confirmation wind[...]

InDuo ™ Blood Glucose Meter InDuo™ SYSTEM AND ACCESSORIES OneT ouch ® Ultra T est Strips OneT ouch ® Ultra Control Solution InDuo ™ Insulin Doser NovoFine ® Needles 10-pack PenFill ® 3 mL Insulin Cartridge OneT ouch ® UltraSoft™ Adjustable blood sampler OneT ouch ® UltraSoft™ Sterile Lancet OneT ouch ® UltraClear ™ cap for altern[...]