Nova Max Link Owner's Manual

Blood glucose monitor

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Nova Max Link™ Blood Glucose Monitor Owner's Guide
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 Link is a trademark of Nova Biomedical.
Copyright 2007 Nova Biomedical Corporation
44619 Rev A 12/2007
1-800-681-7390
www.novamaxlink.com

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Summary of Contents for Nova Max Link

  • 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 Link is a trademark of Nova Biomedical. Copyright 2007 Nova Biomedical Corporation 44619 Rev A 12/2007...
  • Page 2: Important Information

    The Nova Max Link Blood Glucose Monitor is designed to be con- venient and easy to use. The Nova Max Link is designed for wire- less communication with Paradigm® Model 512, 712, or higher insulin infusion pumps. It gives accurate results in just 5 seconds using a very small blood sample.
  • Page 3 Operation is subject to the following 2 conditions: 1. This device has been tested and found to comply with the regulations governing such devices in your area. Please con- tact Nova at 1-800-681-7390.
  • Page 4 • Increase the separation between the blood glucose moni- tor and the device that is receiving/emitting interference. • If you have questions, please contact Nova at 1-800-681- 7390. Notes, Cautions, and Warnings: NOTES provide helpful operating information. CAUTIONS provide information that is important for instrument protection.
  • Page 5: Table Of Contents

    Table of Contents Intended Use .......................1 Symbols ........................2 Monitor Components ..................3 Introduction ......................4 Monitor Display ....................4 The Nova Max Link 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 6 Getting and Applying a Blood Sample from Forearm or Palm .. 23 Limitations and Considerations: Forearm and Palm Testing ..25 Your Test Result ....................27 Sending a Blood Glucose Result to Your Paradigm Model 512, 712, or Higher Insulin Pump ............... 28 Marking a Single Blood Glucose Test So It Is Not Sent to Your Paradigm Model 512, 712, or Higher Insulin Pump ....
  • Page 7: Intended Use

    Intended Use The Nova Max Link 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 control.
  • Page 8: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the Nova Max Link Blood Glucose Monitor. In vitro diagnostic medical device Caution, consult accompanying documents Consult instructions for use...
  • Page 9: Monitor Components

    Monitor Components Test Strip Goes Here LCD Display Right Arrow Button Left Arrow Button Mode Button Nova Max Link Blood Glucose Monitor...
  • Page 10: Introduction

    Introduction Monitor Display When you turn the Nova Max Link Blood Glucose Monitor on, the all segments display appears briefly. This tells you that all the display segments are working properly. Control Low Battery Indicator Marked Test Results Glucose Test...
  • Page 11: The Nova Max Link Blood Glucose Monitor

    Introduction The Nova Max Link 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.
  • Page 12: Kit Contents

    Introduction Kit Contents 1. Nova Max Link™ Blood Glucose Monitor 2. Lancing device* 3. Nova Max™ Blood Glucose Control Solution, Normal (1 bottle)* 4. Lancets (10)* 5. Day Case 6. Battery (CR2450, 3V) 7. Owner’s Guide 8. Quick Reference Guide 9.
  • 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 Link Blood Glucose Monitor can test your blood glucose 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 Link Blood Glucose Monitor. 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 •...
  • 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.
  • Page 16: Talking To Your Pump

    Introduction Talking to Your Pump Your Nova Max Link Blood Glucose Monitor arrives with its “Snd” function already turned on. Every time the meter displays a new blood glucose test result, the meter automatically sends the result to the your Paradigm® Model 512, 712, or higher insulin pump.
  • Page 17: Setting The Time, Date, And Beeper

    Your Nova Max Link Blood Glucose Monitor offers a beeper func- tion that is preset “On. ” This tells you when enough blood is ap- plied to the test strip, when test is completed, and prompts you through other steps in using your monitor.
  • Page 18 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) 1-28 “2008” Month (Flashing) “1”-28 2008 Day (Flashing) 1-”28” 2008 Sample Marking (ON or OFF) “ON”...
  • Page 19: Using The Send (Snd) Function

    Using the Send (Snd) Function Your Nova Max Link Blood Glucose Monitor has a send function. The Send Function allows you to turn on or off sending blood glucose results to your Paradigm Model 512, 712, or higher insu- lin pump.
  • Page 20: Running Control Solution

    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: •...
  • Page 21: Important Information For Control Solution

    If your control solution test results continue to fall outside the range printed on the test strip vial: • The Nova Max Link Blood Glucose Monitor may not be work- ing properly. • Do not use the monitor to test your blood.
  • Page 22: 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 23 Running Control Solution 4. Pick up the monitor with test strip inserted and touch the test strip to the control solu- tion drop. 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.
  • Page 24 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.
  • Page 25: 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 End Into...
  • Page 26 Testing a Blood Sample 5. Use the 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 27 Testing a Blood Sample NOTE: Your monitor arrives from the factory with “Snd” set to “On.” If the glucose result does not flash and the insulin pump does not receive the glucose result, then set “Snd” to “On.” 10. Press the Left/Right buttons to move between marked (√) or unmarked results.
  • Page 28 Testing a Blood Sample WARNING: Your lancing device is for your personal use only. DO NOT share with others. Sharing the lancing device or lancets can transmit serious, even grave infections. To avoid accidental sticks, do not store used lancets in the device after testing or arm the lanc- ing device with a new sterile lancet unless ready to use.
  • Page 29: 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 30 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 31: Limitations And Considerations: Forearm And Palm Testing

    Only use finger or palm testing during these times. The Nova Max Link 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 32 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) •...
  • Page 33: 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...
  • Page 34: Sending A Blood Glucose Result To Your Paradigm Model 512, 712, Or Higher Insulin Pump

    Sending a Blood Glucose Result to Your Paradigm Model 512, 712, or Higher Insulin Pump Your Nova Max Link Blood Glucose Monitor arrives with “Snd” turned “On. ” Thus, when a new blood glucose result is displayed, the monitor will send the result to your pump. The new result will flash on the monitor display while the monitor is sending the result to your Paradigm Model 512, 712, or higher insulin pump.
  • Page 35 Sending a Blood Glucose Result NOTE: If the monitor displays “HI” or “LO,” no blood glucose result is sent to the pump. The monitor uses radio frequency (RF) signals to send the blood glucose result to the pump. If you set “Snd” to “OFF, ” your monitor will not send a RF signal to your pump.
  • Page 36: Marking A Single Blood Glucose Test So It Is Not Sent To Your Paradigm Model 512, 712, Or Higher Insulin Pump

    Marking a Single Blood Glucose Test Marking a Single Blood Glucose Test So It Is Not Sent to Your Paradigm Model 512, 712, or Higher Insulin Pump If you want to take a single blood glucose measurement and not have that result sent to your Paradigm Model 512, 712, or higher insulin pump, you can mark it as a control solution test.
  • Page 37: 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. The monitor is in the off position when the screen is completely blank.
  • Page 38 Review Test Results 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 39: 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 40: 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 41: Cleaning And Care

    Basic Upkeep Cleaning and Care The exterior of the Nova Max Link 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 42: 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 43 Displays, Meanings, Actions Display What it Means What to Do A blood glucose test No action required. result in mg/dL. Result is automatically stored into memory. If “Snd” is “On, ” the result Record the result in your 123 will be flashing logbook.
  • Page 44 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...
  • Page 45 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 46 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.
  • Page 47 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 48 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 49: 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)
  • Page 50: 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.
  • Page 51 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 52: 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 53 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 54: Warranty

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

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