User's Manual www.InDuo.com 2 Diagram of the InDuoTM system Look at the diagram inside this cover for the names of the different parts of the InDuoTM system. You can unfold the diagram to help you while you follow the instructions. The InDuoTM system should be used only in combination with products that are compatible with it and allow the InDuoTM system to function safely and effectively. OneTouch® Ultra test strips are designed to be used with the InDuoTM blood glucose meter. PenFill® 3 mL cartridges and NovoFine® needles are designed to be used with the InDuoTM insulin doser. PenFill® not included. PenFill® and NovoFine® are trademarks of Novo Nordisk A/S. IN TOUCH® and OneTouch® are trademarks of LifeScan, Inc. InDuoTM 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 InDuoTM doser indicates that the product conforms with the provisions in the EC Directive for Medical Devices 93/42/EEC. The InDuoTM 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. InDuoTM SYSTEM AND ACCESSORIES OneTouch® UltraClearTM cap for alternate puncture site OneTouch® UltraSoftTM Sterile Lancet InDuoTM Blood Glucose Meter OneTouch® Ultra Control Solution OneTouch® Ultra Test Strips OneTouch® UltraSoftTM Adjustable blood sampler InDuoTM Insulin Doser NovoFine® Needles 10-pack PenFill® 3 mL Insulin Cartridge InDuoTM BLOOD GLUCOSE METER AND INSULIN DOSER Data port Test port Dose selector Meter display LOT number Residual scale Window Slide C button M button Insulin doser display Push button Release button InDuoTM METER AND INSULIN DOSER DISPLAY SYMBOLS Ctl Indicates a control solution test result. Ketones? Appears when a blood glucose test result falls above 240 mg/dL. Code Appears with the code number of the OneTouch® Ultra Test strip currently in use. 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.) Apply symbol Tells when to apply the sample. 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. Battery symbol Appears when the meter battery power is low or must be replaced. Month Day Hour Minutes Circle Time segment The segments indicate the time passed since delivery. 1 segment represents 1 hour. Confirms that the delivery has been completed. Dose Shows the number of insulin units dialed. InDuoTM COMPONENTS OneTouch® UltraSoftTM Adjustable blood sampler Release button Cap Ejection / Cocking control Deep puncture Indicator mark Puncture depth setting knob Shallow puncture OneTouch® Ultra Test strip Top edge Confirmation window Contact bars OneTouch® Lancet Protective disk NovoFine® 6 mm or 8 mm PenFill® 3 mL Front rubber stopper White bar code band Rear rubber stopper Outer needle cap Inner needle cap Needle Protective tab Threaded plastic cap Glass ball (for insulin suspensions only) 3 CONTENTS Welcome Getting your InDuoTM system ready for use Preparing your InDuoTM meter Preparing your InDuoTM insulin doser to inject insulin Testing your blood glucose levels Injecting your insulin Using the InDuoTM memory functions Checking your previous test results Checking your previous injection Viewing blood glucose test results on a personal computer Comparing InDuoTM meter and laboratory results Caring for your InDuoTM system Important information Display messages and problem-solving guide The InDuoTM meter The InDuoTM insulin doser Specifications Warranty Blood value targets 4 5 5 21 27 41 51 51 54 55 58 60 65 68 69 80 86 87 88 4 WELCOME You have chosen the InDuoTM system, a system designed to simplify the way you manage your diabetes. Featuring an integrated blood glucose meter and insulin doser, InDuoTM 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 InDuoTM system. Read it carefully. Your InDuoTM 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 laboratory results. If you have been using another type of meter, you may notice that the results with the InDuoTM meter are about 12% higher than with your previous system. The InDuoTM meter is designed for use with OneTouch® Ultra test strips only. Your InDuoTM 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 InDuoTM system helps you simplify your insulin therapy and increase your confidence in managing your diabetes. A warranty registration card is included with your InDuoTM system. If you complete it and mail it to us, we will send you a gift. We are sure that you will find your InDuoTM system simple and easy to use. If you have any questions regarding your InDuoTM system, please do not hesitate to call InDuo Customer Services at our toll free number 1-877-520-9056. The InDuoTM 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 InDuoTM SYSTEM READY FOR USE 5 GETTING YOUR InDuoTM SYSTEM READY FOR USE Preparing your InDuoTM meter Setting the time, date, and unit of measurement Your InDuoTM 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 meter battery. Since the InDuoTM 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 InDuoTM meter display. Enter the setting mode · Press and hold down for 3 seconds. · The InDuoTM meter is now in the setting mode and you are ready to change the time using the meter display. 6 GETTING YOUR InDuoTM SYSTEM READY FOR USE Setting the hour · The time will appear first, with the hour digits flashing. · Press and release Ñ until the correct hour is displayed. · To 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 displayed. · To scroll faster, hold Ñ down. GETTING YOUR InDuoTM SYSTEM READY FOR USE 7 Setting the time format · Press and the 12-hour format will start flashing. · Your InDuoTM 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 release Ñ. Pressing Ñ again will return you to the 12-hour format. Setting the year Before setting the date you must first set the time. · With the preferred time format on the display, press and the year digits will start flashing. · Press and release Ñ until the correct year is displayed. · To scroll faster, hold Ñ down. 8 GETTING YOUR InDuoTM 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. · To scroll faster, hold Ñ down. Setting the day · Press and the day setting will start flashing. · Press and release Ñ until the correct day is displayed. · To scroll faster, hold Ñ down. GETTING YOUR InDuoTM SYSTEM READY FOR USE 9 Selecting the unit of measurement · With the correct day on the display, press and the current unit of measurement will start flashing. The InDuoTM 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. The fi unit is commonly used in Canada and some European countries. · Consult your healthcare professional before you change the unit of measure. · If the units are incorrect or have been changed, press Ñ to select the correct units. If the units are correct, just press the button to exit the setting mode. 10 GETTING YOUR InDuoTM SYSTEM READY FOR USE Top edge Apply a sample here, where the narrow channel meets the top edge of OneTouch® Ultra test strip. æ OneTouch® Ultra test strips Your InDuoTM meter is designed for use with OneTouch® Ultra test strips only. · Store the OneTouch® 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 OneTouch® Ultra test strips in their original vial only; do not transfer them to a new bottle or any other container. · After removing a OneTouch® Ultra test strip from the vial, immediately replace the vial cap and close it tightly. · 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. · Use each OneTouch® Ultra test strip immediately after removing it from the vial. · Write the discard date on the vial label when you open it for the first time. Discard remaining 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 Insert this end of OneTouch® Ultra test strip into the InDuoTM meter. GETTING YOUR InDuoTM SYSTEM READY FOR USE 11 · 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. · Do not use OneTouch® Ultra test strips beyond the expiration date printed on the package since using expired OneTouch® Ultra test strips may produce inaccurate results. · 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 reuse a test strip that has had sample applied to it. Refer to your OneTouch® Ultra test strip insert for additional information. 12 GETTING YOUR InDuoTM SYSTEM READY FOR USE Coding your InDuoTM meter Code numbers are used to calibrate the OneTouch® Ultra test strips with the InDuoTM meter. You must code the InDuoTM 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. (Example) Entering the code mode · Start with the InDuoTM meter turned off. · Insert a OneTouch® Ultra test strip to turn on the meter. Push the test strip in until it will go no further. · All segments of the meter display will appear. When you first use the InDuoTM meter, 3 dashes Q will appear, showing there is no code stored in the meter memory. GETTING YOUR InDuoTM 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 OneTouch® Ultra test strip vial. · If the 2 code numbers match, you may begin testing. · If the code numbers do not match, follow the next procedure to recode the InDuoTM meter. Code the InDuoTM meter · Press Ñ to select the correct code. · Each time you press and release Ñ, the number on the display will increase by one. · To scroll faster, hold Ñ 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 R will appear with the units of measurement (Á or fi), indicating that the InDuoTM meter is ready for testing. (Example) 14 GETTING YOUR InDuoTM 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 ...