ABBOTT LABORATORIES

Diabetes Monitoring

Optium Neo Owners Setup Guide Rev A Sept 2013

Owners Setup Guide

2 Pages

TABLE OF CONTENTS  Blood Glucose and Ketone Monitoring System  Owner’s Setup Guide  1  FreeStyle Optium Neo At-A-Glance  2  Meter Symbols  3  Quick Start - Testing Your Blood Glucose  TABLE OF CONTENTS  12 Transferring Meter Data to a Computer  • Displays meter Home screen (shown here) • Displays your test results and other important information  Intended Use  5  Getting to Know Your Meter Turning Your Meter On and Off Checking Your Meter Screen Every Time You Turn it On  Changing Batteries Cleaning Your Meter  USB Port  Setting Up the Meter  7  Testing Your Blood Glucose or Blood Ketone Prepare to Test Performing a Blood Glucose or Blood Ketone Test  8  Understanding Blood Glucose Test Results and Patterns Low Blood Glucose Results High Blood Glucose Results  17 Meter Specifications  Understanding Blood Ketone Test Results  19 References  5  The FreeStyle Optium Neo Blood Glucose and Ketone Monitoring System is for use outside the body only (in vitro diagnostic use) for self testing or professional use as an aid in the management of diabetes. Use for measuring glucose in fresh whole blood samples taken from fingers, forearm, upper arm or the base of the thumb. Use for measuring ketone (β-hydroxybutyrate) in fresh whole blood samples from fingers only. The system may also aid in the management of diabetes by providing the user with suggested recommendations to insulin dose(s) based on healthcare professional entered data.  16 Insulin Dose Logging Set Up for Insulin Dose Logging How to Use Insulin Dose Logging How to Log Additional Rapid-Acting Insulin Doses  • Insert a test strip here  What It Means  Logbook  Breakfast insulin dose  Meter ready for sample application  Lunch insulin dose  Control solution result  Dinner insulin dose  Units of insulin  Fasting test  Insulin  Ketone  Morning long-acting insulin dose  Low battery  Evening long-acting insulin dose  Connected to computer  Insulin dose setup  Setup mode  Low blood glucose or pattern  High blood glucose or pattern  1. Wash and dry hands before and after testing. Note: Check test strip expiry date. 2. Insert strip.  • Insert the test strip into the meter  • Apply blood or control solution to the white target area at the end of the test strip  10  Setting Up the Meter  To confirm that the date and time are set correctly, follow the steps below.  To turn your meter on: • Press the , or • Insert a strip To turn your meter off: for 3 seconds, or • Press and hold the • Do nothing for 2 minutes  Set Time 1. Start with meter off (no test strip inserted) to turn on the meter • Press (e.g. 1:23 PM)  Checking Your Meter Screen Every Time You Turn It On  (e.g. 13:23)  Your meter screen should be fully black when powered off. Each time you turn on your meter, a white start-up test screen will appear for 1 second.  hour  2. Press and hold the time (11:50) on the screen for 3 seconds until the screen changes.  Note: If the meter battery is low, the will appear in both the meter off screen and start-up test screen.  3. Set Time Format (12 hour or 24 hour clock) or to change • Press • Press to continue Note: Your meter can display either a 12 h (1:23 PM) or 24 h (13:23) time format. If you prefer the 12 h format, there is no “AM”. If setting a PM time, until you see the “PM”. continue to press 4. Set Hour • The hour blinks. Press hour • Press to continue  or  hour  Viewing Your Logbook Events  6. Set Month • The month blinks. Press month • Press to continue  day  or  1. While on the Home screen, press your logbook events.  to set the  7. Set Day • The day blinks. Press • Press to continue  to set the  or  to set the day  day  Examples:  month  or  to view  month  minute  5. Set Minutes • The minutes blink. Press minutes • Press to continue  View Logbook  Your meter logbook can store up to 1,000 events – including blood glucose, ketone, and control solution results, insulin doses, and other meter information.  Set Date  If you see any white segments in the black off screen, or any black segments in the white test screen, there may be a problem with the meter. Contact Customer Care.  4. View result. For more information on how to perform a test, see Section 7.  Test Strip Target Area  6  3. Lance test site and apply blood.  Down Button  Turning Your Meter On and Off  Meter Off Screen  • Turns meter on and off and returns to the Home screen  Strip Port  18 Other Symbols  Getting to Know Your Meter  ➧  IMPORTANT: • Use only FreeStyle Optium blood glucose test strips and FreeStyle Optium blood β-Ketone test strips. Other test strips may produce inaccurate results. • See test strip instructions for use for more information about sample types. • Read the instructions in this Owner’s Setup Guide. Failure to follow instructions may cause incorrect results. Practice the testing procedures before using the meter. • Follow your healthcare professional’s advice when testing blood glucose levels and blood ketone levels. • Observe caution when using around children. Small parts may constitute a choking hazard.  Symbol  Power Button  • Insert a data cable here for uploading test results to a computer (data management system required)  15 Troubleshooting  Viewing Your Logbook Events Viewing Your Blood Glucose Averages  Intended Use  What It Means  Quick Start – Testing Your Blood Glucose  14 Taking Care of Your Meter  10 View Logbook  4  Logbook Up Button  6  9  3  Meter Symbols  Symbol  Display Window  Performing a Control Solution Test  2  FreeStyle Optium Neo At-A-Glance  11 Glucose and Ketone Control Solutions  13 Error Messages  4  User’s Manual  1  8. Set Year • Press • Press  to set the  or to set the year to save. Setup complete  2. Press events.  to scroll through to view your logbook  Blood Glucose Result  minute  Start-up Test Screen  Testing Your Blood Glucose or Blood Ketone  Insulin Dose 1. Select your test site. Test site choices for blood glucose testing are fingers, forearm, upper arm, or base of the thumb. Use only fingertip blood samples for blood ketone testing.  Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.  IMPORTANT: • Only use a test strip once. • Read the test strip instructions for use before performing your first blood glucose or ketone test. It contains important information and will tell you how to store and handle the test strips. • The meter and its accessories are for use by a single person. • Refer to the lancing device insert for detailed instructions on how to use the lancing device. • Do not put urine on the test strip.  Performing a Blood Glucose or Blood Ketone Test  Note: Avoid moles, veins, bones, and tendons. Bruising may occur at the test site. If bruising occurs, consider selecting another site.  2. Wash your hands and the test site with soap and warm water. • Rinse and dry thoroughly. • Do not use lotion or cream on the test site.  9  The meter displays blood glucose results in mmol/L. The unit of measurement is preset. You cannot change this setting.  IMPORTANT: The meter displays results from 1.1 - 27.8 mmol/L. Low or high blood glucose results can indicate a potentially serious medical condition.  Low Blood Glucose Results  Notes: • If you are testing blood glucose, you will see a 5-second countdown. If you are testing blood ketone, you will see a 10-second countdown. • Do not remove the test strip from the meter during the countdown. • If the countdown does not start, you may not have applied enough blood to the test strip. See test strip instructions for use for re-application instructions. If the countdown still does not start, remove the used strip and discard it correctly. Start a new test with a new test strip.  What It Means  What To Do  Appears when result is lower than 3.9 mmol/L or the target set on the meter by your healthcare professional.  Follow your healthcare professional’s advice to treat low blood glucose.  If You See . . .  A solid yellow arrow  A pattern of low glucose has developed. If 2 low results occur within the past 5 days AND both are within the same 3-hour time period, the meter will display a blinking .  Follow your healthcare professional’s advice to treat low blood glucose.  What To Do  Appears when result is higher than 13.3 mmol/L or the target set on the meter by your healthcare professional.  Follow your healthcare professional’s advice to treat high blood glucose.  A pattern of high glucose has developed. If 3 high results occur within the past 5 days AND all are within the same 3-hour time period, the meter will display a blinking .  Follow your healthcare professional’s advice to treat high blood glucose.  A blinking yellow arrow  A blinking red arrow  Severe low blood glucose or There may be a problem with the test strip.  What It Means  Blood glucose level is higher than or equal to 13.3 mmol/L.  Repeat the test with a new test strip. If the result is LO, contact your healthcare professional immediately.  Blood Glucose Result example  Appears when result is higher than 27.8 mmol/L  Severe high blood glucose or There may be a problem with the test strip.  Fasting Result  Control Solution Result  Blood Ketone Result example to turn off the meter. Discard the 6. Press and hold used test strip correctly.  Viewing Your Blood Glucose Averages 1. While on the Home screen, press logbook.  The meter displays ketone results in mmol/L, from 0.0 - 8.0 mmol/L. The unit of measurement is preset. You cannot change this setting. IMPORTANT: Follow your healthcare professional’s advice before you make any changes to your diabetes management program.  Blood ketone is expected to be below 0.6 mmol/L.2 High blood ketone may be caused by illness, fasting, vigorous exercise, or uncontrolled blood glucose levels.1-3 Repeat a blood ketone test using a new blood ketone test strip when: • HI appears on the display • Your result is unusually high • You question your result • Your blood ketone result is 0.0 mmol/L, but your blood glucose is higher than 16.7 mmol/L  Display Result is between 0.6 – 1.5 mmol/L.  Result is higher than 1.5 mmol/L.  What It Means High blood ketone. A problem requiring medical assistance may be occurring.  You may be at risk of developing diabetic ketoacidosis (DKA).2-6  What To Do  Your average  Follow your healthcare professional’s advice.  Contact your healthcare professional immediately. Number of tests in this average  Check blood ketone if checking ketones is part of your diabetes management program.  Repeat the test with a new test strip. If the result is HI, contact your healthcare professional immediately.  Note: If you see a this means the meter can suggest a new meal insulin dose. Ignore this if you’re not about to eat a meal and take your meal insulin dose.  -  Appears when result is higher than 8.0 mmol/L.  Note: If you see the error messages E-3 or E-4, consult the Error Messages section in this Owner’s Setup Guide. IMPORTANT: Contact your healthcare professional if you have symptoms that do not match your test result, and you have followed the instructions in this Owner’s Setup Guide.  5. View the result. The test is complete when the result appears on the meter screen (examples shown). The result is stored in memory.  to open the  Understanding Blood Ketone Test Results  High Blood Glucose Results  A solid red arrow  Appears when result is lower than 1.1 mmol/L  ➧  Note: KET will appear on the screen if you have inserted a purple blood ketone strip.  Understanding Blood Glucose Test Results and Patterns  If You See . . .  4. Apply blood to the test strip. Bring the blood drop to the white area at the end of the test strip. The blood is drawn into the test strip. Hold blood to test strip until you see 3 short lines on the meter screen. This means you have applied enough blood.  The blinks, indicating the meter is ready for you to apply a sample to the test strip.  3. Check test strip expiry date. Do not use expired test strips; they may cause inaccurate results.  8  3. Obtain a blood sample. Use the lancing device to obtain a blood sample. (See lancing device instructions for use for more information.)  2. Insert the test strip into the meter until it stops. This will turn on the meter. Notes: • Be sure to check that your meter screen is working properly each time you turn your meter on. If you see any white segments in the black off screen, or any black segments in the white test screen, there may be a problem with the meter. (See Section 5, Getting to Know Your Meter, for more details) • The meter turns off after 3 minutes of inactivity. Remove and reinsert the unused test strip to restart the meter.  Do not use blood samples from alternative sites when: • You think your blood glucose is low or changing rapidly • You have been diagnosed with hypoglycaemic unawareness • Alternative site results do not match the way you feel • You are within two hours of eating a meal, taking insulin, or exercising  Check your ketone: • When you have an illness • When your blood glucose is above 13.3 mmol/L • When you and your healthcare professional feel it is necessary  1. Open the foil test strip packet at the notch and tear down to remove the test strip.  4˚C  Prepare to Test  Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK.  7  Units of Insulin  Very high blood ketone or There may be a problem with the test strip.  Repeat the test with a new test strip. If the result is HI, contact your healthcare professional immediately.  Press or to scroll through 7-, 14- and 30-day averages.  2. While in the logbook, press any time to view your 7-day average. [ ] • Press to view 14-day average. [ ] • Press to view 30-day average. [ ] • Press to return to your logbook events. Notes: • Averages do not include glucose control solution results. • Control solution results not marked as control solution tests may cause averages to be inaccurate. appear on the meter screen when there • are no current events or averages to view. • blood glucose test results are included as 1.1 mmol/L when calculating averages. blood glucose test results are included as • 27.8 mmol/L when calculating averages.
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