Instruction/ maintenance manual of the product In Duo Lifescan
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InDuo ™ Blood Glucose Meter InDuo™ SYSTEM AND ACCESSORIES OneT ouch ® Ultra T est Strips OneT ouch ® Ultra Control Solution InDuo ™ Insulin Doser NovoFine ® 8 mm needles (10-pack sample inclu.
NovoFine ® 6 mm or 8 mm w OneT ouch ® UltraSoft™ Adjustable Blood Sampler OneT ouch ® Ultra T est Strip Penfill ® 3 ml Needle Protective tab Inner needle cap Colour-coded cap Colour- coded band .
3 CONTENTS Welcome 4 Getting your InDuo™ System ready for use 5 Preparing your InDuo™ meter 5 Preparing your InDuo™ insulin doser to inject insulin 21 T esting your blood glucose levels 27 Injec.
4 WELCOME Y ou have chosen the InDuo™ System, designed to simplify the way you manage your diabetes. Featuring an integrated blood glucose meter and insulin doser , InDuo™ System will enable you to check your blood glucose levels and administer insulin using one compact system.
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 Y our InDuo™ meter comes with pre-set values for the time, date, and unit of measurement.
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 minute digits will start flashing.
GETTING YOUR InDuo™ SYSTEM READY FOR USE 7 Setting the time format • Press ˛ and the 12-hour format Ä will start flashing. • Y our InDuo™ 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 .
8 GETTING YOUR InDuo™ 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.
GETTING YOUR InDuo™ 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. • Y our meter has been preset to fi which is the unit of measurement generally used in Canada.
10 GETTING YOUR InDuo™ SYSTEM READY FOR USE æ OneT ouch ® Ultra T est Strips Y our InDuo™ meter is designed for use only with OneT ouch ® Ultra T est Strips. • Store the OneT ouch ® Ultra T est Strip package in a cool, dry place below 30°C (86ºF).
GETTING YOUR InDuo™ SYSTEM READY FOR USE 11 • Apply only OneT ouch ® Ultra Control Solution or a blood sample to the top edge of the OneT ouch ® Ultra T est Strip.
(Example) 12 GETTING YOUR InDuo™ SYSTEM READY FOR USE Coding your InDuo™ meter Code numbers are used to calibrate the OneT ouch ® Ultra T est Strips with the InDuo™ meter . Y ou must code the InDuo™ meter before using it for the first time, and then every time you change to another vial of OneT ouch ® Ultra T est Strips.
GETTING YOUR InDuo™ SYSTEM READY FOR USE 13 Match the code numbers The calibration code is stored in the meter memory until it is changed by the user . 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 T est Strip vial.
14 GETTING YOUR InDuo™ 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 T est Strips are working together as a system and that you are performing the test correctly .
GETTING YOUR InDuo™ 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 30°C (86ºF).
a 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 3 tests in a row that are within the range printed on the OneT ouch ® Ultra T est Strip vial, you are then ready to test your blood.
GETTING YOUR InDuo™ 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.
b c Apply control solution • Shake the control solution vial well. • Remove the cap. • Squeeze the vial and discard the first drop and wipe off the dispenser tip with a clean tissue to obtain an accurate result. • Squeeze the vial again to get a small hanging drop.
GETTING YOUR InDuo™ SYSTEM READY FOR USE 19 æ Caution • If control solution test r esults fall outside the range printed on the OneT ouch ® Ultra T est 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™ meter may not be working properly .
20 GETTING YOUR InDuo™ SYSTEM READY FOR USE The control solution test tr oubleshooting There are several reasons why the results of a control solution test may fall outside the expected range (as printed on the OneT ouch ® Ultra T est Strip vial label).
GETTING YOUR InDuo™ SYSTEM READY FOR USE 21 PREP ARING YOUR InDuo™ INSULIN DOSER TO INJECT INSULIN T o use the InDuo™ insulin doser to inject your insulin, you must first insert a Penfill ® 3 ml cartridge, attach a NovoFine ® 6 mm or 8 mm needle and prime the InDuo™ insulin doser .
c b a 22 GETTING YOUR InDuo™ SYSTEM READY FOR USE T o insert Penfill ® : • Pull out the InDuo™ 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 .
GETTING YOUR InDuo™ SYSTEM READY FOR USE 23 f d • Insert Penfill ® into the InDuo™ insulin doser by pushing it slightly backwards as shown d . The end with the rubber stopper goes in first. Make sure that the colour-coded cap fits firmly into place e .
How to attach a NovoFine ® needle • T ake the protective tab off a NovoFine ® needle. • Screw the NovoFine ® needle firmly onto the colour-coded cap.
Priming your InDuo™ insulin doser for the first time æ 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 release button will be locked. • Press the release button a .
c e d 26 GETTING YOUR InDuo™ SYSTEM READY FOR USE • Dial 8 units c . • Hold the InDuo™ insulin doser with the NovoFine ® needle pointing upwards and tap the slide gently with your finger a few times d , to ensure that any air in Penfill ® rises to the top.
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 T est Strip package insert found in this system kit box carefully before testing.
28 TESTING YOUR BLOOD GLUCOSE LEVELS Check that the InDuo™ meter display is working properly . Y ou 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).
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 .
O NE T Ult r c O NE T OUCH ® UltraSoft 30 TESTING YOUR BLOOD GLUCOSE LEVELS • 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 towards the smaller bumps for a shallower puncture or towards the larger bumps for a deeper puncture d .
TESTING YOUR BLOOD GLUCOSE LEVELS 31 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 site f .
O U g 32 TESTING YOUR BLOOD GLUCOSE LEVELS O NE T OUCH ® U lt r a S o f t Getting a fingertip blood sample The InDuo™ System requires a very small blood drop to perform a test. Y ou may obtain it from a fingertip or arm. (See pages 33 to 35 for information on obtaining a blood sample from the arm).
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.
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.
i O NE T OU C UltraSo f N E T OUCH ® U ltraSoft TESTING YOUR BLOOD GLUCOSE LEVELS 35 h sufficient blood for a test, rubbing the area more vigorously or the brief application of heat may be helpful. Position the sampler Press and hold the sampler against the arm for a few seconds.
36 TESTING YOUR BLOOD GLUCOSE LEVELS Cleaning the OneT ouch ® UltraSoft ™ Blood Sampler • Clean the sampler with soapy 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 .
TESTING YOUR BLOOD GLUCOSE LEVELS 37 Incorrect Correct (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 OneT ouch ® UltraSoft™ Blood Sampler .
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.
TESTING YOUR BLOOD GLUCOSE LEVELS 39 Reading the results: • Y our blood glucose test result will appear after the InDuo™ meter counts down from N to A .
Special messages HI: If your blood glucose test result is above 33.3 mmol/L (600 mg/dL), 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 appears call your healthcare professional immediately .
INJECTING YOUR INSULIN 41 a 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™ insulin doser . Do not press any buttons on the meter cap while you remove the insulin doser .
c e f 42 INJECTING YOUR INSULIN How to prime your InDuo™ insulin doser • Make sure that a NovoFine ® needle is attached (see page 41), the push button is pressed in completely , and the slide is closed. If the slide is not closed, the release button will be locked.
c 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 b . The display will show 0 • Dial the number of units you need by turning the dose selector at a steady speed c .
44 INJECTING YOUR INSULIN a How to correct a dialed dose • If you accidentally dial a larger dose than you need, dial back to the correct number of units a . • Y ou can continue changing the dose that has been dialed until you press the push button.
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.
b c 46 INJECTING YOUR INSULIN • When the circle symbol § appears b , the full insulin dose has been delivered and you can withdraw the needle. • After the injection, put the outer needle cap on and unscrew the needle c . • Discard the needle carefully .
INJECTING YOUR INSULIN 47 What to do when Penfill ® is nearly empty • Do not try to inject an insulin suspension (cloudy insulin) if the 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.
Change Penfill ® as described on pages 22 and 23. Then prime the InDuo™ insulin doser as described on page 42. Dial the remaining number of units to complete your dose.
INJECTING YOUR INSULIN 49 How to change Penfill ® • Make sure that the push button is pressed in completely a . • Make sure the NovoFine ® needle has been removed from the insulin doser . • Open the slide. • T ake out the used Penfill ® cartridge b .
20 50 INJECTING YOUR INSULIN InDuo™ insulin doser function check If you think that the InDuo™ insulin doser is not working properly , follow this procedure: • Screw on a new NovoFine ® needle, as described on page 41. • Prime the insulin doser as described on page 42.
USING THE InDuo™ MEMOR Y FUNCTIONS 51 USING THE InDuo™ MEMOR Y FUNCTIONS Both the InDuo™ meter and the InDuo™ insulin doser have memory functions.
(Example) 52 USING THE InDuo™ 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 .
USING THE InDuo™ MEMOR Y FUNCTIONS 53 Other memory functions of the InDuo™ meter The InDuo™ 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.
54 USING THE InDuo™ MEMOR Y FUNCTIONS Checking your previous injection • Pull out the InDuo™ insulin doser . When the insulin doser is pulled out all the insulin doser display symbols are turned on telling you that the insulin doser display is fully functioning.
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 T ouch ® Diabetes Management Software which is available from LifeScan.
56 VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PC How to transfer glucose test results to your PC Install In T ouch ® software • Install In T ouch ® software on your computer following the instructions provided in the In T ouch ® user’ s manual.
VIEWING BLOOD GLUCOSE TEST RESUL TS ON A PC 57 • While the InDuo™ meter is in the communication mode, you cannot use the InDuo™ meter to perform a blood glucose test. If the InDuo™ meter is in either the memory mode or the setting mode, it will not respond to computer commands.
58 COMP ARING THE InDuo™ METER AND LABORA TOR Y RESUL TS COMP ARING THE InDuo™ METER AND LABORA TOR Y RESUL TS The InDuo™ meter blood glucose test results and laboratory results are both expressed in plasma-equivalent units. However , the results you obtain from your meter may differ from your laboratory results due to normal variations.
COMP ARING THE InDuo™ METER AND LABORA TOR Y RESUL TS 59 • Never use your InDuo™ meter with blood that has been collected in a test-tube with a grey-coloured top.
CARING FOR YOUR InDuo™ SYSTEM • Y our InDuo™ System is a precision instrument. T o ensure it works accurately and safely , please handle it with care. • Avoid situations where your InDuo™ component parts can be damaged. • Store your InDuo™ System in its carrying case after each use.
CARING FOR YOUR InDuo™ SYSTEM 61 Power supply Y our InDuo™ System is powered by batteries making it portable and self-contained. Y our InDuo™ comes with 2 battery systems already installed: • The meter battery provides you with enough power to perform approximately 1000 blood glucose or control solution tests.
62 CARING FOR YOUR InDuo™ SYSTEM When to change your InDuo™ meter battery Y our InDuo™ 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.
CARING FOR YOUR InDuo™ SYSTEM 63 How to replace the InDuo™ meter battery • T o replace the meter battery , make sure that the InDuo™ meter is turned off. • T urn your InDuo™ meter over and locate the battery compartment. • Open the battery door on the back of the meter a .
64 CARING FOR YOUR InDuo™ SYSTEM When to replace your InDuo™ insulin doser A flashing display indicates that the insulin doser battery power is low . • Be sure to replace your InDuo™ insulin doser within 30 days. The battery cannot be changed.
IMPORT ANT INFORMA TION 65 æ IMPORT ANT INFORMA TION • As a precautionary measure, always carry a spare insulin delivery device, and a Penfill ® cartridge, in case your InDuo™ doser is lost or damaged. • Always prime your InDuo™ insulin doser (see page 24 or 42) to ensure insulin flow: • Before each injection.
66 IMPORT ANT INFORMA TION • Y our InDuo™ System is tough but could still be damaged. So handle it with care, do not drop it and avoid knocking it against hard surfaces. If your 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 pages 14 to 16).
IMPORT ANT INFORMA TION 67 • T ake 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), this may change the concentration of the insulin.
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™ System. The following is a summary of all display messages.
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 69 The InDuo™ meter Here is a summary of the different messages given on the InDuo™ meter display . This indicates that the meter is running a system check. It appears whenever a OneT ouch ® Ultra T est Strip is inserted and when the InDuo™ blood glucose meter is turned on.
70 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE This is the code number stored in the InDuo™ meter Make sure that this code number matches the code number on the vial of the OneT ouch ® Ultra T est Strips you are using.
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 t.
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 33.
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 memo.
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™ meter Do not use the InDuo™ meter .
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 T est Strip or there is a problem with the meter Repeat the test with a new OneT ouch ® Ultra T est Strip.
76 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Meter display What it means Action Error message that indicates one of the following conditions may be present: 1. Y ou may have high glucose and have tested in an environment near the low end of the operating temperature range (6-44°C/43-111°F) 2.
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 77 Meter display What it means Action Repeat the test with a new OneT ouch ® Ultra T est Strip. Refer to pages 32 to 38 for proper sample application procedure.
78 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Meter display What it means Action The battery symbol É appears on the display with the unit of measurement.
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 79 Meter display What it means Action Repeat the test after the InDuo™ meter and OneT ouch ® Ultra T est Strips have reached a temperature within the operating range The InDuo™ meter has detected that the temperature is above the operating range.
80 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Here ar e the answers to some questions you might ask when using your InDuo™ meter: What should I do if the InDuo™ meter does not display a message .
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 81 What should I do if the InDuo™ meter does not start running the blood glucose test after the OneT ouch ® Ultra T est Strip has been inserted? Probabl.
82 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 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 doser . Message What it means Action If the display goes off, press the release button, and the push button will jump out.
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 83 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.
84 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 .
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 85 Here ar 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.
86 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE Why does no insulin appear when I try to prime the InDuo™ insulin doser? 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.
DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 87 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.
88 SPECIFICA TIONS InDuo™ System Size: 123 mm x 54 mm x 35 mm (4.84 in x 2.13 in x 1.38 in) Weight: 125 g with battery (4.40 ounces) Operating ranges: T emperature: 6-40°C (43-104ºF)* Relative humidity: 10-90% Hematocrit: 30-55% InDuo™ meter Result range: 1.
89 InDuo™ doser Cartridge: 3 ml Penfill ® Needle: NovoFine ® max 8 mm length Dose: 1IU increment, minimum = 1IU, maximum = 70IU Memory: 1 (last dose and time since last dose) Power source: Interna.
90 BLOOD GLUCOSE V ALUE T ARGETS Times of day Glucose ranges for people Y our target ranges (mmol/L) without diabetes (mmol/L) Before br eakfast 3.9 - 5.8 Before lunch or dinner 3.9 - 6.1 1 hour after meals Less than 8.9 2 hours after meals Less than 6.
An important point after buying a device Lifescan In Duo (or even before the purchase) is to read its user manual. We should do this for several simple reasons:
If you have not bought Lifescan In Duo yet, this is a good time to familiarize yourself with the basic data on the product. First of all view first pages of the manual, you can find above. You should find there the most important technical data Lifescan In Duo - thus you can check whether the hardware meets your expectations. When delving into next pages of the user manual, Lifescan In Duo you will learn all the available features of the product, as well as information on its operation. The information that you get Lifescan In Duo will certainly help you make a decision on the purchase.
If you already are a holder of Lifescan In Duo, but have not read the manual yet, you should do it for the reasons described above. You will learn then if you properly used the available features, and whether you have not made any mistakes, which can shorten the lifetime Lifescan In Duo.
However, one of the most important roles played by the user manual is to help in solving problems with Lifescan In Duo. Almost always you will find there Troubleshooting, which are the most frequently occurring failures and malfunctions of the device Lifescan In Duo along with tips on how to solve them. Even if you fail to solve the problem, the manual will show you a further procedure – contact to the customer service center or the nearest service center
