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  5. Owner's Manual

Nova Max Owner's Manual

Summary of Max

  • Page 1

    Nova biomedical 200 prospect street waltham, ma 02454-9141 u.S.A. Telephone: 1-800-681-7390 web site: www.Novacares.Com 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 tr...

  • Page 2: Thank You

    Nova thanks you for choosing the nova max blood glucose monitor. This owner’s guide contains important information on the monitor and how it works. 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 ac...

  • Page 3: 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 ne...

  • Page 4: Table of Contents

    Table of contents intended use .......................................................................................................1 symbols ................................................................................................................2 introduction ................................

  • Page 5

    Basic upkeep .................................................................................................... 28 battery check ............................................................................................... 28 battery replacement .....................................................

  • Page 7: Intended Use

    1 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 sp...

  • Page 8: Symbols

    2 warning: blood samples and blood products are po- tential sources of hepatitis and other infectious agents. Handle all blood products with care. Wear gloves when performing measurements on another person. Items that are used to measure glucose, i.E., test strips, lancets, and alcohol swabs, must b...

  • Page 9: Lcd Display

    3 nova max blood glucose monitor lcd display left arrow button mode button right arrow button test strip goes here introduction monitor components.

  • Page 10: Marked Test

    4 marked test results memory result blood or control drop indicator control low battery indicator glucose test results mg/dl average test results am or pm indicator date/day nova max monitor screen introduction monitor display when you turn the nova max blood glucose monitor on, the all segments dis...

  • Page 11: Introduction

    5 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 ava...

  • Page 12: Kit Contents

    6 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. Owner’s guide 9. Log book 10. Warranty card 11. Gettin...

  • Page 13: Introduction

    7 introduction 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. Reaso...

  • Page 14: Introduction

    8 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 ...

  • Page 15: Lancing Device

    9 • 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...

  • Page 16

    10 setting the time, date, and beeper setting the time, date, and beeper having the correct time and date of each blood glucose test result helps you and your healthcare professional track changes in your therapy. It is important to set the correct time and date so you have records of when you teste...

  • Page 17: Modes

    11 this brings the monitor display to the first setup screen: time. Setting the time, date, and beeper modes screen display hour (flashing) “10”:00“ am ” minutes (flashing) 10:”55” am year (flashing) 12-28 “2006” month (flashing) “12”-28 2006 day (flashing) 12-”28” 2006 sample marking (on or off) “o...

  • Page 18: Control Solution

    12 control solution control solution is a liquid that contains a fixed amount of glu- cose. • use this solution to test that your monitor and test strips are working properly. • use this solution to practice or to check that you are following the correct testing procedure without using your own bloo...

  • Page 19: Running Control Solution

    13 important information for control solution • use only nova max control solution for the test. • check the expiration date on the control solution vial. Do not use control solution past the expiration date or you may get inaccurate results. • store only for 3 months after first opening. When you o...

  • Page 20: Running Control Solution

    14 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. 2. Press the left/right butto...

  • Page 21: Running Control Solution

    15 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...

  • Page 22: Running Control Solution

    16 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. Contr...

  • Page 23: Running A Test

    17 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. 2. After 3 seconds, the blinking blood drop symbol appears. Note: if a test is not performed ...

  • Page 24: Testing A Blood Sample

    18 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 countdow...

  • Page 25: Testing A Blood Sample

    19 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. The keys are disabled until a strip is inserted. Results and marki...

  • Page 26: Testing A Blood Sample

    20 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. 1b. Select the palm heel or palm side test site in the highlighted areas as ...

  • Page 27: Testing A Blood Sample

    21 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 sh...

  • Page 28: Testing A Blood Sample

    22 testing a blood sample limitations and considerations: forearm and palm testing some patients test their blood glucose at sites other than the finger because it is generally less painful. Note: results from the forearm may be different from fingertip results when glucose levels are changing rapid...

  • Page 29: Testing A Blood Sample

    23 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 insuli...

  • Page 30: Your Test Result

    24 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 prescrib...

  • Page 31: Your Test Result

    25 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...

  • Page 32

    26 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 complet...

  • Page 33: Data Review In Memory

    27 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. After reviewing the 30 day average, press the mode button to shut off the monitor, o...

  • Page 34: Battery Check

    28 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. Continue with testin...

  • Page 35: Battery Replacement

    29 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. Then, the mon...

  • Page 36: Cleaning and Care

    30 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. Your warranty and all claim...

  • Page 37: Displays, Meanings, Actions

    31 displays, meanings, actions this section addresses the messages that appear on your dis- plays, what they mean, and what action you need to take. Displays, meanings, actions display what it means what to do system check. Verifies that all segments are working. Appears when: • monitor is turned on...

  • Page 38: Displays, Meanings, Actions

    32 displays, meanings, actions display what it means what to do your blood glucose reading is higher than 600 mg/dl. You may have high blood sugar. Retest your blood glucose immediately. If your reading is still hi, you should treat as prescribed by your healthcare professional and/or contact your h...

  • Page 39: Displays, Meanings, Actions

    33 displays, meanings, actions display what it means what to do the average of all blood glucose test results tak- en in the last 24 hours. No action required. No test results in the last 24 hours. No action required. The average of all blood glucose test results taken in the last 7 days. No action ...

  • Page 40: Display

    34 display what it means what to do the average of all blood glucose test results taken in the last 30 days. No action required. No test results in the last 30 days. No action required. There are no results in memory. No action required. Battery is getting low, but you can still perform a test. Batt...

  • Page 41: Displays, Meanings, Actions

    35 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 error monitor is outside the requ...

  • Page 42: Display

    36 display what it means what to do monitor does not turn on after inserting a test strip. • test strip is inserted upside down or not completely in. • battery is dead. • battery is installed in- correctly or there is no battery in the monitor. Insert the test strip correctly with the nova name and ...

  • Page 43: Specifications

    37 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 batter...

  • Page 44: Limitations

    38 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 45: Appendix

    39 • 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. Appendix.

  • Page 46: Appendix

    40 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. If in data review mode when the...

  • Page 47: Appendix

    41 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. - while monitor i...

  • Page 48: Appendix

    42 appendix warranty your nova max blood glucose monitor is warranted to be free of mate- rial and workmanship defects for 3 years from the date of purchase (except as noted below). If at any time during the first 3 years after purchase, your nova max monitor does not work for any reason (other than...