Abbott FreeStyle InsuLinx Owner's Booklet

Blood glucose monitoring system

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Owner's booklet (58 pages)

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Page 1 Customer Service: 1800-801-478 www.AbbottDiabetesCare.com.au FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. All other trademarks are the property of their respective owners. This product(s) and/or its use are protected by one or more of the following patents: US6,071,391;...
Page 2 FreeStyle InsuLinx at a Glance Touch screen Displays your test results and other important information. Use touch screen buttons to work with your meter. USB port Plug in your micro USB cable here to download test results. Meter Home button...
Page 3: Table Of Contents
Table of Contents Symbols ..................1 Taking Care of Your Meter .
Page 4: Symbols
Indicates a control solution test result remaining in body When removing your new FreeStyle InsuLinx system from its packaging, check that the contents are undamaged and that you have all parts listed on the box. If any parts are missing or damaged, contact Customer Service.
Page 5: Intended Use
Set up Your Meter for the First Time Use outside the body only (in vitro diagnostic use). Set the language, current date and time. The FreeStyle InsuLinx Blood Glucose Monitoring System is intended for use in the quantitative Step Action measurement of glucose in capillary whole blood from the finger, hand, forearm, upper arm and venous whole blood.
Page 6: Getting To Know Your Meter
Getting to Know Your Meter Tap the arrow buttons to change the date. Then tap save. Today’s date Learn how to turn your meter on and off, find the Home screen, use the Help button, and use the backlight and strip light. April, 2012 Turn Your Meter On and Off To turn the meter on:...
Page 7: Use The "?" Help Button
Use the “?” Help Button Turn the Strip Light On and Off Enter target To turn the strip light on: Tap the Help button anytime you see it and want more information. range in mmol/L 12:43 • If a test strip is inserted, press and hold the meter Home button for Logbook 3 seconds.
Page 8: Test Your Blood Glucose
Test Your Blood Glucose Step Action Select your test site. Get a blood glucose test result. Note: Avoid moles, veins, bones, and tendons. Bruising may Available You will need: Test Sites • occur at the test site. If bruising occurs, consider selecting FreeStyle Lite test strips that are not expired.
Page 9: Your Test Results
Perform the test. View the test result. a. Insert a test strip and close the test strip vial. a. A butterfly will appear on the screen while you wait for 07:30 your result. The meter will beep twice when your result is b.
Page 10: Low And High Blood Glucose Results
Low and High Blood Glucose Results Your Test Results Display What To Do View, understand, and mark your test results; know what to do if you receive an error message. Note: The meter displays results in mmol/L. This unit of measure is set and cannot be changed. Follow your health care professional’s advice to treat low blood glucose.
Page 11: Use Meal Markers
Use Meal Markers Display What To Do Mark your blood glucose test result as ‘Before meal’ or ‘After meal’ , or as another time. Meal markers 1. LO may indicate that your blood glucose is very low. Follow your health care are used to provide additional information for Weekly Messages and in the FreeStyle Auto-Assist professional’s advice immediately and then repeat the test.
Page 12: Error Messages
Error Messages Control Solution Test A control solution test should be performed when you are not sure of your results and want to Your meter will explain what an error message means, its possible causes, confirm that your meter and test strips are working correctly. and what to do about it.
Page 13 Step Action Compare the control solution result to the range printed on the test strip vial. The result should fall within the range. At the Home screen, tap Settings 12:43 Then tap Perform control solution test. Notes: • If you see an error message on the screen, your meter will explain what it means, Logbook Settings its possible causes, and what to do next.
Page 14: View Logbook
View Logbook Notes (Continued): • If you turned on the Notes feature through FreeStyle Auto-Assist, you can tap (Continued) Review blood glucose history; review and log meals, insulin doses, notes about your test results the add or edit notes button to add or edit notes to your most recent result. and control solution tests.
Page 15 Change Your Meter Settings Personalise Your Meter Change time and date, sounds or language. Change the picture you see when you perform a blood glucose test. Step Action Step Action At the Home screen, tap Settings At the Home screen, tap Extras 12:43 Then tap the setting you want to change.
Page 16: Set Up And Use Weekly Messages
Set up and Use Weekly Messages Tap done to return to the Home screen. Note: You can change your weekly messages settings anytime by simply repeating the Turn on and use weekly messages. This feature will help you identify patterns in your blood glucose setup procedure.
Page 17: Important Information About The Rapid-Acting Insulin Calculator
Use Your Insulin Calculator with Easy Option Important information about the Rapid-acting Insulin Calculator Use the Easy Option if you start with a fixed dose of rapid-acting insulin for meals. This feature requires an understanding of the use of insulin. Misuse or misunderstanding of this feature and the suggested dose may lead to inappropriate insulin dosing.
Page 18 Review your suggested dose. Tap log dose to save to your logbook and then take your dose. Suggested dose Suggested dose If you do not tap log dose, your dose will not be stored in your a. If needed, tap the arrow buttons to adjust your suggested logbook.
Page 19: Use Your Insulin Calculator With Advanced Option
Use Your Insulin Calculator with Advanced Option After reviewing your result, tap the Calculator button and confirm 06:58 your last logged rapid-acting insulin dose if needed (you will be Use the Advanced Option if you count carbohydrates (in grams or carbohydrate portions) to adjust mmol asked this if your health care professional turned on the Active your rapid-acting insulin dose for meals.
Page 20 Review your suggested dose. Tap log dose to save to your logbook and then take your dose. If you Suggested dose Suggested dose do not tap log dose, your dose will not be stored in your logbook. a. If needed, tap the arrow buttons to adjust your suggested dose for Adjust if needed Adjust if needed any planned activity, a smaller or larger meal, sickness, etc.
Page 21: Set Up And Use Reminders
Set up and Use Reminders Active Insulin symbol If your health care professional turned on the Active Insulin feature, this 12:43 Set your meter to remind you when to test, when to take your insulin, or for other alarms. symbol may now appear on your home screen. It shows an estimate Set up Reminders of the amount of rapid-acting insulin still in your body and how much Logbook...
Page 22: Taking Care Of Your Meter
Taking Care of Your Meter You can now: Reminders • Tap the On/Off button to turn a reminder on or off. • Take care of your meter and keep it operating safely. 08:30 Tap add new to set more reminders. Changing Batteries Tap done to return to the Home screen.
Page 23: Cleaning Your Meter
Cleaning Your Meter Troubleshooting Step Action What It Means What To Do Assemble cleaning supplies: • 1. Test strip • Test strip is inserted Cloth dampened with: • is inserted incorrectly or not fully Mild detergent/soap and water, or Insert the test strip as shown. •...
Page 24: Freestyle Auto-Assist: Progress Reporting Software
What It Means What To Do FreeStyle Auto-Assist: Progress Reporting Software • 2. The test Blood drop is too small Add blood to the same sample area within Getting to Know Your FreeStyle Auto-Assist Software does not 60 seconds, or repeat the test using a new test start after strip and a larger blood drop.
Page 25: Install The Freestyle Auto-Assist Software
Install the FreeStyle Auto-Assist Software If the installation does not automatically start, follow the steps below to install the software. Windows Computer Systems (includes Windows 7, Windows Vista and Windows XP) Note: FreeStyle Auto-Assist is compatible with both PC and Mac operating systems. Step Action Step...
Page 26: Freestyle Auto-Assist System Requirements
FreeStyle Auto-Assist System Requirements Set up Advanced Features for Your Meter Logbook • At minimum, a computer with a USB 2.0 compliant hub running Windows with a Turn on additional meter logbook features such as the ability to log all your insulin doses and add up single-core 1GHz processor and 512MB RAM or running Mac OS X Leopard with an Intel to 11 custom notes that can be logged with your blood glucose test results.
Page 27: Set Up Notes For Your Meter Logbook
Set up Notes for Your Meter Logbook Set up Meter Reminders Set your meter to remind you when to test, when to take your insulin, or for other alarms. Step Action The software allows you to set up to 12 different personal reminders. Go to the Meter tab.
Page 28: Set Up Your Meter Personalisation
Set up Your Meter Personalisation Set up Weekly Messages on Your Meter Change the picture you see when you perform a blood glucose test. Turn on weekly messages. This feature will help you identify patterns in your blood glucose results. Step Action IMPORTANT: Ask your health care professional for your blood glucose target ranges.
Page 29: Freestyle Auto-Assist Reports
FreeStyle Auto-Assist Reports The FreeStyle Auto-Assist software allows you to choose from six reports: Report What It Does Report What It Does The Snapshot report is a general summary of data for the specified date The Daily Statistics Report provides an overview of blood glucose, range.
Page 30: Set Up Or Change Report Preferences
Set up or Change Report Preferences Create, View, Save and Print Reports The FreeStyle Auto-Assist software allows you to set the following report preferences: Step Action • • Report set Auto-save options • • Go to the Reports tab. On the left side of the screen, click Create Reports. Time frame Print colour •...
Page 31: Additional Freestyle Auto-Assist Features
Additional FreeStyle Auto-Assist Features Rapid-acting Insulin Calculator Setup Feature What It Does How To Access This feature can assist your patients with calculating their rapid-acting insulin doses based on meal First time Meter Sets your meter’s If you have not yet set up your meter, plug it into and blood glucose level information.
Page 32: Which Setup Is Right For Your Patient
Which Setup is Right for Your Patient? Set up the Rapid-acting Insulin Calculator Setup Options Who is this for? What information is required? IMPORTANT: If the time on the meter is wrong, this may lead to an incorrect suggested dose. Easy Patients who start with a 1.
Page 33: Easy Setup
Easy Setup Enter the blood glucose correction target. Tap next. Correction target in mmol/L This is the desired target range for blood glucose values before IMPORTANT: You must complete all the steps in the insulin calculator setup in order to use the meals.
Page 34 Easy Option Tap done to save the settings. When the patient uses the calculator, the meter will use the settings to suggest a rapid-acting insulin dose based on the meal selected and the latest This page can be used to record insulin calculator settings for your patient. blood glucose result.
Page 35: Advanced Setup
Advanced Setup IMPORTANT: You must complete all the steps in the insulin calculator setup in order to use the insulin calculator. Step Action To use the Advanced Setup, tap the button to choose Advanced. Choose setup option Tap next. Advanced For patients who count carbs (in grams or carb portions) to...
Page 36 Rapid-acting insulin dose suggestion is How do you want your patient to correct their glucose? To a single Carbohydrate How does your ratio Carbohydrate ratio based on grams of carbs. patient correct their target or within a target range? Answer this appropriately. 1 unit insulin for: glucose? 1 u insulin for...
Page 37 Enter the correction factor (for example: Enter the hours that rapid-acting insulin remains active in the body. Correction factor Insulin duration Correction factor if 1 unit of insulin lowers blood glucose Tap next. 1 u insulin for 1 u insulin for 4:30 Correction factor 2.8 mmol/L, then the correction factor is 2.8).
Page 38 The graph below demonstrates how the insulin calculator estimates the amount of active insulin as Tap done to save the settings. To learn how to use the calculator, refer to the Use Your a function of logged insulin dose and insulin duration over time. It shows the relationship between Insulin Calculator with Advanced Option section.
Page 39 Advanced Option This page can be used to record insulin calculator settings for your patient. Carbohydrate Carbohydrate 1 Carbohydrate Portions Ratio Ratio Portion This is the number of grams of carbs that For 1 carb portion take 1 unit of insulin for 10 grams one unit of rapid-acting insulin will cover 12 grams...
Page 40: Change The Insulin Calculator Settings
Change the Insulin Calculator Settings Step Action At the Home screen, tap Extras 12:43 Then tap Rapid-acting Insulin Calculator. Extras: Logbook I want to set up... Personalisation Weekly Messages Rapid-acting Insulin Calculator Enter the access code provided only to health care Enter code to unlock calculator professionals.
Page 41: Change Rapid-Acting Insulin Dose Increments In Freestyle Auto-Assist
Change Rapid-acting Insulin Dose Increments in FreeStyle Auto-Assist Meter Specifications Set the insulin dose increments to either 1.0 or 0.5 units for use with the Rapid-acting Insulin Calculator and Insulin Log features. Altitude Up to 3,048 metres (10,000 feet) above sea level Step Action Assay method...
Page 42: Insulin Calculator Specifications
Insulin Calculator Specifications Minimum Computer System must only be used with EN60950-1 rated computers. Requirements Use a USB certified cable. Parameter Unit Range or Value Operating relative 5% to 90% (non-condensing) Blood Glucose Target Range mmol/L 3.9 – 10.0 humidity Single Blood Glucose Target mmol/L 3.9 –...
Page 43: Appendix A - End Of Meter Life/ Backup Battery Removal
Appendix A — End of Meter Life/ Backup Battery Removal Appendix B — Table of Symbols Note: Carry out this process only when you no longer intend to use the meter. The meter will no Consult instructions for use In vitro diagnostic medical device longer operate once opened to remove the backup battery.
Page 44 References: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm224025.htm “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens”...

Abbott FreeStyle InsuLinx Owner's Booklet

Important Information about Your Blood Glucose Monitoring System

Set up Your Meter for the First Time

Getting to Know Your Meter

Test Your Blood Glucose

Your Test Results

Control Solution Test

View Logbook

Personalise Your Meter

Change Your Meter Settings

Set up and Use Weekly Messages

Important Information about the Rapid-Acting Insulin Calculator

Set up and Use Reminders

Taking Care of Your Meter

Troubleshooting

Freestyle Auto-Assist: Progress Reporting Software

Rapid-Acting Insulin Calculator Setup (for Health Care Professionals Only)

Meter Specifications

Insulin Calculator Specifications

Appendix A - End of Meter Life/ Backup Battery Removal

Appendix B - Table of Symbols

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Summary of Contents for Abbott FreeStyle InsuLinx

Table of Contents