Nova Max Owner's Manual
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Nova Max Owner's Manual

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Nova Max
®
Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Telephone:
Web site:
Made in the USA by Nova Biomedical Corporation
U.S. Patent No. 6,258,229, 6,837,976, 6,942,770,
CA 2,375,089 and other U.S. and foreign patents pending.
Nova Max is a registered trademark of Nova Biomedical.
Copyright 2007 Nova Biomedical Corporation
40677 Rev E 05/2009
Blood Glucose Monitor Owner's Guide
1-800-681-7390
www.novacares.com

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  • Page 1 Made in the USA by Nova Biomedical Corporation U.S. Patent No. 6,258,229, 6,837,976, 6,942,770, CA 2,375,089 and other U.S. and foreign patents pending. Nova Max is a registered trademark of Nova Biomedical. Copyright 2007 Nova Biomedical Corporation 40677 Rev E 05/2009...
  • Page 2 Please read it carefully before us- ing your new monitor. The Nova Max Blood Glucose Monitor is designed to be conve- nient and easy to use. It gives accurate results in just 5 seconds using a very small blood sample.

  • Page 3: Important Information

    Important Information! • Before you begin using your new Blood Glucose Monitor, please read all of the instructions provided in this Owner’s Guide. • Your monitor uses a CR2450 3-volt coin cell battery. To begin using your monitor, you need to install the enclosed battery. See Battery Replacement (page 29) to install a new battery. • Perform all quality control checks recommended in your Owner’s Guide. • Consult with your diabetes healthcare professional and follow his/her guidance for your blood glucose monitoring routine.

  • Page 4: Table Of Contents

    Table of Contents Intended Use .......................1 Symbols ........................2 Introduction ......................3 Monitor Components ..................3 Monitor Display ....................4 The Nova Max Blood Glucose Monitor ..........5 Overview ......................5 Kit Contents .....................6 Environmental ....................6 Before Testing ....................7 Reasons to Check for Low Blood Glucose ..........7 Important Health Related Information ..........7...
  • Page 5 Basic Upkeep ....................28 Battery Check ....................28 Battery Replacement ................. 29 Cleaning and Care ..................30 Displays, Meanings, Actions ............... 31 Appendix ......................37 Specifications ....................37 Chemistry Measurement ................. 37 Limitations ....................38 Instructional Notes ..................40 Warranty ......................42 TOC-2...

  • Page 7: Intended Use

    Intended Use The Nova Max Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in capillary whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes con- trol. The Nova Max Blood Glucose Monitor is specifically indicat- ed for the quantitative measurement of glucose in whole blood capillary samples obtained from the fingertip, palm and forearm.

  • Page 8: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the Nova Max Blood Glucose Monitor. In vitro diagnostic medical device Caution, consult accompanying documents Consult instructions for use...

  • Page 9: Introduction

    Introduction Monitor Components Test Strip Goes Here LCD Display Right Arrow Button Left Arrow Button Mode Button Nova Max Blood Glucose Monitor...

  • Page 10: Monitor Display

    Introduction Monitor Display When you turn the Nova Max Blood Glucose Monitor on, the all segments display appears briefly. This tells you that all the dis- play segments are working properly. Control Low Battery Indicator Marked Test Results Glucose Test...

  • Page 11: The Nova Max Blood Glucose Monitor

    Introduction The Nova Max Blood Glucose Monitor The monitor is a hand-held testing device that measures glucose (sugar) in capillary blood. The test strip is touched to a drop of blood to initiate the test process. • A simple one-step process provides a blood glucose result. • Test results are available in 5 seconds.

  • Page 12: Kit Contents

    Introduction Kit Contents 1. Nova Max Blood Glucose Monitor 2. Vial of Nova Max Glucose Test Strips (10)* 3. Lancing device* 4. Lancets (10)* 5. Nova Max Blood Glucose Control Solution, Normal (1 bottle)* 6. Battery (CR2450, 3V) 7. Quick reference guide 8.

  • Page 13: Before Testing

    Before testing and to ensure accurate glucose results, wash your hands and the testing site then thoroughly dry these areas. The Nova Max Blood Glucose Monitor can test your blood glu- cose on the fingers, forearm, or palm. The sample size is just 0.3 µL of blood.

  • Page 14: Test Strips

    Introduction Test Strips The Nova Max Test Strips are designed for use with your Nova Max Blood Glucose Monitor only. Use each test strip only once, then discard. DO NOT reapply blood to the test strip. • Requires a very small blood volume: 0.3 µL • Automatically draws blood into the test area of the strip • Can be handled with clean, dry hands without affecting glu-...

  • Page 15: Lancing Device

    Introduction • Test strips should only be stored for 3 months after opening the vial. When first opening a new vial of test strips, count forward 3 months and write that date on the vial. Discard any remaining test strips after the date you have written on the vial. • Do not tamper with the test strip. WARNING: The test strip vial contains small parts.

  • Page 16: Setting The Time, Date, And Beeper

    Your Nova Max Blood Glucose Monitor offers a beeper function that is preset “On. ” This tells you when enough blood is applied to the test strip, when test is completed, and prompts you through other steps in using your monitor.
  • Page 17 Setting the Time, Date, and Beeper This brings the monitor display to the first setup screen: time. MODES SCREEN DISPLAY Hour (Flashing) “10”:00“ ” Minutes (Flashing) 10:”55” Year (Flashing) 12-28 “2006” Month (Flashing) “12”-28 2006 Day (Flashing) 12-”28” 2006 Sample Marking (ON or OFF) “ON”...

  • Page 18: Control Solution

    Perform a Control Solution Test The control solution test confirms that your monitor and test strips are working correctly. A control solution test is similar to a blood glucose test, except you use Nova Max Control Solution and not a blood sample. You should run a control solution test: • When you first get your monitor and at least once a week...

  • Page 19: Important Information For Control Solution

    • Shake the control solution well before using. Caution: The Nova Max Control Solution range printed on the test strip vial is for control solution only. It is used to test the perfor- mance of the monitor and test strip. It is not a recommended range for your blood glucose level.

  • Page 20: Testing A Quality Control Solution

    Running Control Solution Testing a Quality Control Solution 1. Insert a test strip into the monitor. If monitor was off, the screen displays all segments for 2 seconds then the blinking blood drop symbol appears. NOTE: If the strip is removed before you start the test, the screen goes blank.
  • Page 21 Running Control Solution NOTE: The on-screen Control Symbol flashes on and off repeatedly until sufficient control solution has been added to the test strip. (Beeper sounds if enabled.) 5. A glucose quality control test result is available on-screen in 5 seconds. The display does a countdown from 5 to 1. 6.
  • Page 22 Running Control Solution Out-of-range results may be caused by the following: • An error in performing the control test, retest and follow the instructions carefully. • The control solution may have expired or have been con- taminated. Check the expiration date on the control solution vial. Control solution is good for only 3 months after opening. Make sure the control solution vial is closed when not in use. • Expired test strip - Check the expiration date on the test strip vial.

  • Page 23: Running A Test

    Running a Test Running a Test 1. Insert a test strip into the monitor. If monitor was off, the screen displays all segments for 2 seconds. NOTE: If the strip is removed before you start the test, the screen goes blank. Apply Blood Drop Here Insert this...
  • Page 24 Testing a Blood Sample 5. Use a lancing device, loaded with a new lancet, to puncture the finger. (See lancing device instructions for use.) 6. Squeeze the finger to form a drop of blood. 7. Touch the end of the test strip to the blood drop until the test strip is full and the on- screen countdown timer begins.
  • Page 25 Testing a Blood Sample 12. If test result is above 600 mg/dL, the screen displays HI. If test result is below 20 mg/dL, the screen displays LO. NOTE: The monitor will time out after 2 minutes of non-use or if the strip is removed.

  • Page 26: Getting And Applying A Blood Sample From Forearm Or Palm

    Testing a Blood Sample Getting and Applying a Blood Sample from Forearm or Palm 1a. Select the Forearm test site in the high- lighted areas as shown. NOTE: Thick hair at the sample site may cause the blood drop to smear. Palm Side 1b.
  • Page 27 Testing a Blood Sample 4. Continue to hold the device, pressing FIRMLY until a proper blood drop forms. The clear cap allows you to see the blood drop. 5. Apply blood drop to the edge of the test strip. The blood is drawn into the test strip. Hold the monitor to the blood drop until you hear a short beep or see the monitor begin to count down.

  • Page 28: Limitations And Considerations: Forearm And Palm Testing

    Only use finger or palm testing during these times. The Nova Max reduces the pain of blood glucose monitoring significantly by requiring only 0.3 µL of blood sample. CAUTION: Always seek the advice of your doctor or healthcare professional before choosing to use forearm and palm sites.
  • Page 29 Testing a Blood Sample Do not use forearm testing: • For at least 2 hours after you have eaten or injected insulin • If you have recently exercised • If you think that your blood glucose is low • If you think that your blood glucose may be changing rapidly (e.g., after a meal, after taking insulin, or during or after exercise) • If you are not aware of symptoms when your blood glucose is low (hypoglycemic) • If your forearm test results do not match the way you feel, retest using your finger or palm. Consider NOT using forearm testing if you: • Are ill • Are under extra stress...

  • Page 30: Your Test Result

    Your Test Result Your Test Result Your blood glucose test result is displayed on the monitor. If test result is higher than 600 mg/dL, the monitor displays “HI. ” You may have high blood sugar. Retest your blood glucose immediately using a new test strip. If your reading is still high, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.
  • Page 31 Your Test Result NOTE: Test results greater than 240 mg/dL may mean high blood sugar (hyperglycemia). Test results lower than 60 mg/dL may mean low blood sugar (hypoglycemia). If you get results in these ranges, retest your blood glucose. If your reading is still in these ranges, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.

  • Page 32: Review Test Results In Memory

    Review Test Results in Memory Review Test Results in Memory NOTE: If a test strip is inserted while in the Data Review mode, the monitor immediately switches to test mode. To review test results that are stored in memory, start with the monitor in the off position.
  • Page 33 Data Review in Memory 4. To review 1 day, 7 day, 14 day, and 30 day average results, press the Mode button. 5. If there are less than 2 test results in memory, the screen dis- plays 000. If no results, the screen displays 3 dashes. 6.

  • Page 34: Basic Upkeep

    Basic Upkeep Battery Check The monitor is powered by a single coin cell battery, CR2450 (3V). At the first displaying of the battery icon in the upper right corner of the screen and the blood drop at the lower left corner of the screen, the monitor has sufficient charge for 20 more tests.

  • Page 35: Battery Replacement

    Basic Upkeep Battery Replacement Replace the battery as follows: 1. Remove the back battery cover on the monitor. 2. Remove the battery and re- place with a new one with the + side facing up. 3. Replace the cover. NOTE: After the battery is replaced, the monitor displays the all segments screen.

  • Page 36: Cleaning And Care

    Basic Upkeep Cleaning and Care The exterior of the Nova Max Blood Glucose Monitor should only be cleaned with alcohol wipes/swabs. Keep liquids from entering the test strip port or the Left, Right, and Mode buttons. CAUTION: DO NOT attempt to open the monitor to make any re- pairs.

  • Page 37: Displays, Meanings, Actions

    Displays, Meanings, Actions Displays, Meanings, Actions This section addresses the messages that appear on your dis- plays, what they mean, and what action you need to take. Display What it Means What to Do System Check. Verifies No action required. If that all segments are all segments are not working.
  • Page 38 Displays, Meanings, Actions Display What it Means What to Do Your blood glucose Retest your blood reading is higher than glucose immediately. 600 mg/dL. You may If your reading is still have high blood sugar. HI, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.
  • Page 39 Displays, Meanings, Actions Display What it Means What to Do The average of all blood No action required. glucose test results tak- en in the last 24 hours. No test results in the last No action required. 24 hours. The average of all blood No action required.
  • Page 40 Displays, Meanings, Actions Display What it Means What to Do The average of all blood No action required. glucose test results taken in the last 30 days. No test results in the last No action required. 30 days. There are NO results in No action required. memory.
  • Page 41 Displays, Meanings, Actions Display What it Means What to Do Software Error Call Customer Service at 1-800-681-7390, 24 hours a day, 7 days a week. System Hardware Error Call Customer Service at 1-800-681-7390, 24 hours a day, 7 days a week. Operating Temperature Monitor is outside the Error...
  • Page 42 What it Means What to Do Monitor • Test strip is inserted Insert the test strip does not upside down or not correctly with the Nova turn on after completely in. name and white tip fac- inserting a ing up and out. test strip.

  • Page 43: Appendix

    Appendix Specifications Test Measured Blood Glucose Glucose Methodology Glucose oxidase biosensor Glucose Test Results mg/dL (Plasma values) Sample type Capillary whole blood Glucose Test range 20 to 600 mg/dL Acceptable Hematocrit range 25% to 60% Length of Test 5 seconds Test Strip Volumes 0.3 µL Battery Life (nominal) 1000 Tests Low Battery Life...

  • Page 44: Limitations

    Appendix Limitations The Nova Max Test Strips give accurate results when the follow- ing limitations are observed: • The test strips should not be used to diagnose diabetes or to test newborns. • Each test strip is for single use only. Do not reuse. Use a new sterile Nova Max Test Strip each time you test. • Your test strips are for personal use only. DO NOT share with others. • Use only fresh capillary whole blood. Do not use serum or plasma.
  • Page 45 Appendix • Test results may be falsely low if the patient is severely dehy- drated. • Critically ill patients should not be tested with home blood glucose monitors.

  • Page 46: Instructional Notes

    Appendix Instructional Notes 1. If in setup mode when the test strip is inserted, the monitor saves all values entered up to that point and immediately switches to test mode. Upon exiting test mode the monitor screen goes blank and does not return to setup mode. 2.
  • Page 47 Appendix While monitor is in sleep mode (OFF), pressing the MODE button less than 1.5 seconds wakes up the monitor and enters data review mode. While monitor is in sleep mode (OFF), pressing the MODE button greater than 3.0 seconds wakes up the monitor and enters setup mode.

  • Page 48: Warranty

    3. We have no knowledge of the performance of the Nova Max Monitor when used with test strips other than Nova Max Test Strips. There- fore, we make no warranty as to the performance of the Nova Max Monitor when used with any test strips other than Nova Max Test Strips.

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