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Nova Max Plus Glucose & Ketone Meter Kit

Regular Price: $48.50

Special Price: $19.99

Product code: 2

Availability: In stock

Quick Overview:

Nova Max Plus measures both glucose and blood ketone with the same monitor.



Nova Max Plus measures glucose or blood ketone with a tiny, 0.3 microliter blood sample. Glucose results are available in 5 seconds. Ketone results are available in 10 seconds, using a separate ketone test strip. There is no coding for Nova Max glucose or ketone test strips.


Included in the kit is a Nova Max Glucose/Ketone monitor, lancing device with alternate site testing cap, 10 lancets, warranty card, Quick Reference Guide, carrying case, battery, Owner’s Guide, and log book.

Details

The Nova Max Plus Glucose/Ketone monitoring system uses advanced measurement technology to measure both blood glucose and ketone levels with the same meter. The American Diabetes Association (ADA) recommends blood ketone testing for people with diabetes whenever the blood sugar level is 250 mg/dL or larger, especially as part of diabetes sick day management. With both glucose and ketone measuring on the same monitor, Nova Max Plus is ideal for children or adolescents with diabetes, insulin pump users, and anyone with either type 1 or type 2 diabetes who uses insulin. Nova Max Plus automatically reminds the user to check the blood ketones whenever a blood sugar level is 250 mg/dL or higher.

Nova Max glucose test strips were proven the most accurate among the leading glucose monitor brands in an independent 2011 study*. Nova Max glucose test strips require a very small amount of blood, just 0.3 microliters, with alternate site glucose testing available from either the palm or forearm. Ketone test strips require only 0.8 microliters of blood.

Nova Max Plus is easy to use and provides rapid results. Simply insert a glucose or ketone test strip and the meter automatically converts to the appropriate measuring mode. There is no coding required for either glucose or blood ketone monitoring. Glucose results are displayed in just 5 seconds, ketone results in just 10 seconds. A 33 gauge Sureflex lancing device and ten 33 gauge lancets for virtually pain-free testing are included in the monitor kit. Nova Max Plus meters can store 400 test results.

The Nova Instant Savings Card is included in every monitor kit. The Nova card can be used at most retail pharmacies to reduce the cost of Nova Max glucose test strips to a $15 co-pay with most insurance plans. In addition, Nova’s Instant Savings Card allows for cash purchase of Nova Max glucose test strips for $20 per box at retail pharmacies, with unlimited card use and no registration.

The Nova Max Plus Monitor Kit includes a Nova Max Plus Glucose/Ketone monitor, a Sureflex lancing device with alternate site testing cap, 10 lancets, warranty card, Quick Reference Guide, carrying case, battery, Owner’s Guide and log book.

*O’Kane M, et. al., How Accurate are Glucose Meters Used for Patient Testing, Poster presented at European Association for the Study of Diabetes, September 2011, Lisbon Portugal.

<h2>The Best Overall Glucose Monitor</h2> <p>Nova Max Plus incorporates advanced technology for accurate and precise self-monitoring of blood glucose and ketones by people with diabetes. Nova Max Plus has the most comprehensive features for fast, easy, and error-free blood glucose and ketone monitoring.</p> <h3>Glucose and Ketones on the Same Monitor</h3> <p>The Nova Max Plus Glucose Meter automatically converts itself to a Ketone meter by inserting the Nova Max Plus Ketone strip.</p> <h3>Why Ketone Measurements Are Important</h3> <p>Diabetic Ketoacidosis (DKA) is a life-threatening metabolic complication of diabetes with a mortality rate of 2%-10% <sup>1</sup></p> <p>DKA is the leading cause of hospitalization, morbidity, and death in children with Type 1 diabetes <sup>2</sup></p> <p>The use of a blood test for early detection of increased blood ketone levels can help to avert DKA <sup>3,4,5</sup></p> <p>According to the ADA, blood ketone testing should be performed on sick days and whenever glucose is greater than 250-300 mg/dL.</p> <h3>No Coding Needed</h3> <p>Miscoded meters can lead to glucose errors as large as 50%</p> <h3>No Maltose Error</h3> <p>Keeps some patients from getting falsely elevated glucose results from the presence of other sugars in the blood such as maltose.</p> <h3>Tiny 0.3 Microliter Sample Size</h3> <p>Less pain for patients.</p> <h3>Thin 33 Gauge Lancets</h3> <p>Thinnest on the market – virtually pain free lancing –especially important for patients who test frequently.</p> <h3>Fast 5-Second Glucose Results and 10-Second Ketone Results</h3> <h3>Alternate Site glucose Testing</h3> <h3>The Best Overall Glucose Meter</h3> <img src="/wp-content/themes/nova/images/nova-max-plus-chart.png" alt="nova max link comparison chart"> <p>For more information on the Nova Max Plus meter visit <a href="http://www.novacares.com" target="_blank">www.novacares.com</a></p> <hr> <p><sup>*</sup> Based on lancets included with the featured glucose monitoring systems.</p> <p><sup>**</sup> On August 13, 2009 the FDA advised healthcare facilities to avoid using glucose test strips with GDH-PQQ enzyme. <br>The FDA advisory notice reported 13 patient deaths caused by interference from maltose and other non-glucose sugars. Source: <a href="http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm">http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm</a>.</p> <p><sup>1</sup> Laffel L. Endocrinol Metab Clin North Am 2000;29:707-723.</p> <p><sup>2</sup> Casteels K et al. Rev Endoc Metab Disord 2003;4(2):159-166.</p> <p><sup>3</sup> Laffel LM et al. Diabet Med 2005;23(3):278-284.</p> <p><sup>4</sup> Umpierrex GE et al. Treat Endocrinol 2003;2(2):95-108.</p> <p><sup>5</sup> Guerci B et al. Diabetes Metab 2005;31:401-406.</p> <p>Date: August 13, 2009 Dear Healthcare Practitioner: This is to alert you to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. The following provides background information on this problem, a summary of fatality reports FDA has received, and recommendations to reduce the risk. This problem can occur wherever these products are used including in-patient and out-patient healthcare facilities, and at home. Nature of the problem GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. When these non-glucose sugars are present in the patient’s blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result which may suggest the need for clinical action. This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma, or death. In addition, cases of actual hypoglycemia may go unrecognized if the patient and healthcare practitioner rely solely on the test result obtained with the GDH-PQQ glucose test strips. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars The unaffected methods are glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD). Laboratory-based blood glucose assays do not use GDH-PQQ methodology and are not subject to falsely elevated results from non-glucose sugars. Recommendations Avoid using GDH-PQQ glucose test strips in healthcare facilities. List of GDH-PQQ Glucose Test Strips If your facility currently uses GDH-PQQ glucose test strips, NEVER use them on patients: who are receiving interfering products**, or from whom or about whom you cannot obtain information regarding concomitant medication use, e.g., patients who are unresponsive or cannot adequately communicate. **Interfering products containing non-glucose sugars include: Extraneal (icodextrin) peritoneal dialysis solution Some Immunoglobulins: Octagam 5%, Gamimune N 5%***, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB Orencia (abatacept) Adept adhesion reduction solution (4% icodextrin) BEXXAR radioimmunotherapy agent Any product containing, or metabolized into maltose, galactose or xylose. Use ONLY laboratory-based glucose assays on these patients. Determine whether patients are receiving interfering products on admission and periodically during their stay at your facility. Educate staff and patients about the potential for falsely elevated glucose results in the presence of certain non-glucose sugars when using GDH-PQQ glucose test strips. Consider using drug interaction alerts in computer order entry systems, patient profiles and charts to alert staff to the potential for falsely elevated glucose results. Periodically verify glucose meter results with laboratory-based glucose assays if you are using GDH-PQQ test strips in patients who are not receiving interfering products. *** Within the U.S., Gamimune N 5% has not been manufactured since December 2005, and no lots are in distribution in the U.S. In addition, an Advice for Patients can be found on the FDA Consumer website. Reports received by FDA From 1997-2009, FDA received 13 reports of death associated with GDH-PQQ glucose test strips in which there was documented interference from maltose or other non-glucose sugars. Six of the 13 deaths have occurred since 2008 despite FDA’s efforts to communicate the risk. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances; one was receiving Potacor R, one was receiving Octagam (IVIG), and another was receiving an infusion that contained maltose. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated results. Eight reports specified that test result values generated on GDH-PQQ test strips were 3 to 15 times higher than corresponding laboratory results. For example, in one patient the GDH-PQQ system generated a result of 200 mg/dL while the laboratory result was 19 mg/dL. In another case, a patient undergoing peritoneal dialysis with Extraneal was tested with a GDH-PQQ test strip which gave a result of 193 mg/dL, while the result obtained using a laboratory instrument was 8 mg/dL. Some reports indicated that serious patient injury, such as hypoglycemia, confusion, neurologic deterioration, severe hypoxia, brain damage, and coma occurred prior to death. FDA is working with manufacturers to address patient safety problems with GDH-PQQ glucose test strips and will continue to monitor adverse events associated with these products. Reporting adverse events FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect a reportable adverse event associated with a glucose meter or glucose test strip, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices and assist in the identification of potential future problems associated with medical devices. If you suspect a falsely elevated blood glucose value associated with a non-glucose sugar interference, include information about the associated drug or biologic product in your adverse event report. We also encourage you to report any medical device adverse events related to glucose meters or glucose test strips that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. This can be done online at https://www.accessdata.fda.gov /scripts/medwatch /medwatch-online.htm, by phone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178; or by mailing FDA form 3500 (download from http://www.fda.gov/ Safety/MedWatch/ HowToReport/DownloadForms) to MedWatch, 5600 Fishers Lane, Rockville, MD 20857-9787. </p> <h2>The Best Overall Glucose Monitor</h2> <p>Nova Max Plus incorporates advanced technology for accurate and precise self-monitoring of blood glucose and ketones by people with diabetes. Nova Max Plus has the most comprehensive features for fast, easy, and error-free blood glucose and ketone monitoring.</p> <h3>Glucose and Ketones on the Same Monitor</h3> <p>The Nova Max Plus Glucose Meter automatically converts itself to a Ketone meter by inserting the Nova Max Plus Ketone strip.</p> <h3>Why Ketone Measurements Are Important</h3> <p>Diabetic Ketoacidosis (DKA) is a life-threatening metabolic complication of diabetes with a mortality rate of 2%-10% <sup>1</sup></p> <p>DKA is the leading cause of hospitalization, morbidity, and death in children with Type 1 diabetes <sup>2</sup></p> <p>The use of a blood test for early detection of increased blood ketone levels can help to avert DKA <sup>3,4,5</sup></p> <p>According to the ADA, blood ketone testing should be performed on sick days and whenever glucose is greater than 250-300 mg/dL.</p> <h3>No Coding Needed</h3> <p>Miscoded meters can lead to glucose errors as large as 50%</p> <h3>No Maltose Error</h3> <p>Keeps some patients from getting falsely elevated glucose results from the presence of other sugars in the blood such as maltose.</p> <h3>Tiny 0.3 Microliter Sample Size</h3> <p>Less pain for patients.</p> <h3>Thin 33 Gauge Lancets</h3> <p>Thinnest on the market – virtually pain free lancing –especially important for patients who test frequently.</p> <h3>Fast 5-Second Glucose Results and 10-Second Ketone Results</h3> <h3>Alternate Site glucose Testing</h3> <h3>The Best Overall Glucose Meter</h3> <img src="/wp-content/themes/nova/images/nova-max-plus-chart.png" alt="nova max link comparison chart"> <p>For more information on the Nova Max Plus meter visit <a href="http://www.novacares.com" target="_blank">www.novacares.com</a></p> <hr> <p><sup>*</sup> Based on lancets included with the featured glucose monitoring systems.</p> <p><sup>**</sup> On August 13, 2009 the FDA advised healthcare facilities to avoid using glucose test strips with GDH-PQQ enzyme. <br>The FDA advisory notice reported 13 patient deaths caused by interference from maltose and other non-glucose sugars. Source: <a href="http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm">http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm</a>.</p> <p><sup>1</sup> Laffel L. Endocrinol Metab Clin North Am 2000;29:707-723.</p> <p><sup>2</sup> Casteels K et al. Rev Endoc Metab Disord 2003;4(2):159-166.</p> <p><sup>3</sup> Laffel LM et al. Diabet Med 2005;23(3):278-284.</p> <p><sup>4</sup> Umpierrex GE et al. Treat Endocrinol 2003;2(2):95-108.</p> <p><sup>5</sup> Guerci B et al. Diabetes Metab 2005;31:401-406.</p> <p>Date: August 13, 2009 Dear Healthcare Practitioner: This is to alert you to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death. The following provides background information on this problem, a summary of fatality reports FDA has received, and recommendations to reduce the risk. This problem can occur wherever these products are used including in-patient and out-patient healthcare facilities, and at home. Nature of the problem GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. When these non-glucose sugars are present in the patient’s blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result which may suggest the need for clinical action. This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma, or death. In addition, cases of actual hypoglycemia may go unrecognized if the patient and healthcare practitioner rely solely on the test result obtained with the GDH-PQQ glucose test strips. Other glucose test strip methodologies are not affected by the presence of non-glucose sugars The unaffected methods are glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD). Laboratory-based blood glucose assays do not use GDH-PQQ methodology and are not subject to falsely elevated results from non-glucose sugars. Recommendations Avoid using GDH-PQQ glucose test strips in healthcare facilities. List of GDH-PQQ Glucose Test Strips If your facility currently uses GDH-PQQ glucose test strips, NEVER use them on patients: who are receiving interfering products**, or from whom or about whom you cannot obtain information regarding concomitant medication use, e.g., patients who are unresponsive or cannot adequately communicate. **Interfering products containing non-glucose sugars include: Extraneal (icodextrin) peritoneal dialysis solution Some Immunoglobulins: Octagam 5%, Gamimune N 5%***, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB Orencia (abatacept) Adept adhesion reduction solution (4% icodextrin) BEXXAR radioimmunotherapy agent Any product containing, or metabolized into maltose, galactose or xylose. Use ONLY laboratory-based glucose assays on these patients. Determine whether patients are receiving interfering products on admission and periodically during their stay at your facility. Educate staff and patients about the potential for falsely elevated glucose results in the presence of certain non-glucose sugars when using GDH-PQQ glucose test strips. Consider using drug interaction alerts in computer order entry systems, patient profiles and charts to alert staff to the potential for falsely elevated glucose results. Periodically verify glucose meter results with laboratory-based glucose assays if you are using GDH-PQQ test strips in patients who are not receiving interfering products. *** Within the U.S., Gamimune N 5% has not been manufactured since December 2005, and no lots are in distribution in the U.S. In addition, an Advice for Patients can be found on the FDA Consumer website. Reports received by FDA From 1997-2009, FDA received 13 reports of death associated with GDH-PQQ glucose test strips in which there was documented interference from maltose or other non-glucose sugars. Six of the 13 deaths have occurred since 2008 despite FDA’s efforts to communicate the risk. The deaths occurred in healthcare facilities. Ten of the 13 patients were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances; one was receiving Potacor R, one was receiving Octagam (IVIG), and another was receiving an infusion that contained maltose. Patients were treated with insulin doses or insulin drips that were guided by falsely elevated results. Eight reports specified that test result values generated on GDH-PQQ test strips were 3 to 15 times higher than corresponding laboratory results. For example, in one patient the GDH-PQQ system generated a result of 200 mg/dL while the laboratory result was 19 mg/dL. In another case, a patient undergoing peritoneal dialysis with Extraneal was tested with a GDH-PQQ test strip which gave a result of 193 mg/dL, while the result obtained using a laboratory instrument was 8 mg/dL. Some reports indicated that serious patient injury, such as hypoglycemia, confusion, neurologic deterioration, severe hypoxia, brain damage, and coma occurred prior to death. FDA is working with manufacturers to address patient safety problems with GDH-PQQ glucose test strips and will continue to monitor adverse events associated with these products. Reporting adverse events FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect a reportable adverse event associated with a glucose meter or glucose test strip, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices and assist in the identification of potential future problems associated with medical devices. If you suspect a falsely elevated blood glucose value associated with a non-glucose sugar interference, include information about the associated drug or biologic product in your adverse event report. We also encourage you to report any medical device adverse events related to glucose meters or glucose test strips that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. This can be done online at https://www.accessdata.fda.gov /scripts/medwatch /medwatch-online.htm, by phone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178; or by mailing FDA form 3500 (download from http://www.fda.gov/ Safety/MedWatch/ HowToReport/DownloadForms) to MedWatch, 5600 Fishers Lane, Rockville, MD 20857-9787. </p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p><h1>Nova Max® <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> Owner’s Guide</h1> <ul> <li><br> Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141 U.S.A.<br> Telephone: 1-800-681-7390 Web site: www.novacares.com<br> 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<br> 40677 Rev E 05/2009<br> THANK YOU<br> Nova thanks you for choosing the Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a>. 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 <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> is designed to be conve-nient and easy to use. It gives accurate results in just 5 seconds using a very small blood sample. This small sample allows you to use a thinner lancet because not as much blood is needed to do a blood sugar test. The monitor also has memory that stores your blood sugar test results to help you and your healthcare profes-sional manage your diabetes care. Before you get started, it is important to complete the Warranty Registration Card included in your kit and mail it back to Nova. Doing this will help us better serve your needs.<br> If you need to contact us, please call Customer Service 24 hours a day, 7 days a week, in the US at 1-800-681-7390 or visit our web-site at www.novacares.com.<br> Important Information!<br> • Before you begin using your new <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a>, please read all of the instructions provided in this Owner’s Guide.<br> • 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.<br> • Perform all quality control checks recommended in your Owner’s Guide.<br> • Consult with your diabetes healthcare professional and follow his/her guidance for your blood glucose monitoring routine.<br> • These recommendations apply to all blood glucose monitors and are supported by the American Association of Diabetes Educators (AADE), the American Diabetes Association (ADA), the US Food and Drug Administration (FDA), and the Advanced Medical Technology Association (AdvMed).<br> Notes, Cautions, and Warnings:<br> NOTES provide helpful operating information. CAUTIONS provide information that is important for instrument<br> protection.<br> WARNINGS provide information that is important for user protec-tion or about risk for inaccurate results.<br> Table of Contents<br> Intended Use1 Symbols 2 Introduction3<br> Monitor Components3 Monitor Display4 The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> 5 Overview5 Kit Contents6 Environmental6 Before Testing 7 Reasons to Check for Low Blood Glucose7 Important Health Related Information7 Test Strips 8 Important Nova Max Test Strip Information8 Lancing Device9<br> Setting the Time, Date, and Beeper 10 Control Solution 12 Perform a Control Solution Test 12 Important Information for Control Solution. 13 Testing a Quality Control Solution 14 Running a Test 17 Getting and Applying a Blood Sample from Forearm or Palm 20 Limitations and Considerations: Forearm and Palm Testing 22 Your Test Result 24 Review Test Results in Memory 26<br> TOC-1<br> Basic Upkeep. 28 Battery Check 28 Battery Replacement 29 Cleaning and Care 30<br> Displays, Meanings, Actions 31 Appendix 37 Specifications 37 Chemistry Measurement 37 Limitations 38 Instructional Notes 40 Warranty 42<br> TOC-2<br> Intended Use<br> The Nova Max <a href="https://storefront.novacares.com/storefront/"><a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a></a> 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 <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> is specifically indicat-ed for the quantitative measurement of glucose in whole blood capillary samples obtained from the fingertip, palm and forearm. </li> <li>The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> is intended for use<br> outside the body (in vitro diagnostic use).</li> <li>It should only be used with Nova Max Test Strips and Nova<br> Max Control Solution. </li> <li>It should be used for testing glucose (sugar) and only with<br> fresh capillary whole blood samples. </li> <li>It should NOT be used to diagnose diabetes or to test new-<br> borns. </li> </ul> <ol> <li>It should NOT be stored in the refrigerator or in the car.<br> WARNING: The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> contains small parts. Keep the monitor out of reach of small children and pets. If you have hypoglycemia unawareness, a blood glucose moni-tor is critical to your care. Since any monitor may fail, break, or be misplaced, you should always have a backup monitor.<br> <br> Symbols<br> 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<br> are used to measure glucose, i.e., test strips, lancets, and alcohol swabs, must be disposed of in accordance to local regulations to avoid risk to anyone.<br> Symbols<br> The following are symbols that are used in this manual, on insert sheets, and on the Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a>.<br> In vitro diagnostic medical device Caution, consult accompanying documents<br> Consult instructions for use Biological risk Catalog number Temperature limitation</li> <li><br> Introduction<br> Monitor Components<br> Test Strip Goes Here<br> LCD Display<br> Left Arrow Button<br> Right Arrow Button<br> Mode Button<br> Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a></li> <li><br> Introduction<br> Monitor Display<br> When you turn the Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> on, the all segments display appears briefly. This tells you that all the dis-play segments are working properly.<br> Control<br> Low Battery Indicator<br> Glucose Test Results mg/dL<br> Average Test Results AM or PM Indicator<br> Marked Test Results<br> Memory Result<br> Blood or Control Drop Indicator<br> Date/Day Nova Max Monitor Screen<br> Hour/Minute</li> </ol> <ul> <li>Introduction The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a><br> 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.</li> <li>Test results are available in 5 seconds.</li> <li>There is memory for one common user’s set of test results<br> (400). </li> <li>The monitor is powered by a battery that can perform for ap-<br> proximately 1000 tests.<br> CAUTION: The monitor should be handled with care. Dropping, rough handling, etc. may damage the monitor. If the monitor is not to be used for an extended period of time, remove the battery to eliminate the risk of battery leakage. Also, protect the monitor from moisture, prolonged direct sunlight, and extreme temperatures.<br> Overview<br> To perform a test, the operator simply inserts a test strip; waits for the blood drop symbol to appear on the screen; brings the test strip to the drop of blood; and obtains a glucose test result in 5 seconds. The test result is automatically stored into the moni-tor’s memory. The operator can recall and review test data stored in the monitor, including the average for user results.<br> </li> <li>Introduction<br> Kit Contents<br> 1. Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> 2. Vial of Nova Max Glucose Test Strips (10)* 3. Lancing device* 4. Lancets (10)* 5. Nova Max Blood Glucose Control Solution, Normal<br> (1 bottle)* 6. Battery (CR2450, 3V) 7. Quick reference guide 8. Owner’s Guide 9. Log Book 10. Warranty Card 11. Getting Started Poster<br> * These items are not included in the mail order ver-sion of the monitor.<br> Environmental</li> <li>The storage temperature range for the monitor: -13°F to 115°F (-25°C to 46°C)</li> <li>The storage temperature range for the Test Strips: 59°F to 86°F (15°C to 30°C)</li> <li>The monitor operational temperature range: 57°F to 104°F (14°C to 40°C)</li> <li>The relative humidity range: 10% to 90% non-condensing<br> Introduction<br> Before Testing<br> Before testing and to ensure accurate glucose results, wash your hands and the testing site then thoroughly dry these areas. The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> can test your blood glu-cose on the fingers, forearm, or palm.<br> The sample size is just 0.3 μL of blood.<br> Reasons to Check for Low Blood Glucose<br> <br> You have symptoms such as weakness, sweating, nervous-ness, headache, or confusion. You took insulin, but have delayed eating. Your doctor or healthcare professional advises you to do so.<br> Important Health Related Information<br> If you are experiencing symptoms that are not consistent with your <strong>blood glucose test</strong> results and you have followed all instruc-tions described in the Owner’s Guide, call your doctor or health-care professional.<br> 7<br> Introduction<br> Test Strips<br> The Nova Max Test Strips are designed for use with your Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> only. Use each test strip only once, then discard. DO NOT reapply blood to the test strip.<br> • 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-<br> cose readings<br> Insert This End Into Monitor<br> Important Nova Max Test Strip Information<br> Apply Blood Drop to Front Edge<br> • Use only Nova Max Test Strips when testing. • Remove the test strip from the vial only when ready to test. • Store the test strip package in a cool, dry place below 86°F<br> (30°C). Do not refrigerate or freeze. • Do not store near heat or moisture. • Store the test strips in their original vial only. • After removing a test strip from the vial, immediately replace<br> the vial cap and close tightly. • Do not use test strips beyond the expiration date printed on<br> the package as this may cause inaccurate results.<br> 8<br> Introduction<br> • 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.<br> • Do not tamper with the test strip.<br> WARNING: The test strip vial contains small parts. Keep the test strip vial away from children and pets.<br> Lancing Device<br> The diagram below shows the components of the Lancing Device. Refer to the Instructions for Use insert sheet for the Lancing Device for detailed instructions.<br> Depth Adjustment<br> Release Button<br> Force Adjustment<br> 9<br> Setting the Time, Date, and Beeper<br> Setting the Time, Date, and Beeper<br> Having the correct time and date of each <strong>blood glucose test</strong> 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 tested. If you do not set the time and date, all blood glucose monitoring results will be marked and will not be included in averages.<br> Your Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> 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.<br> NOTE: Remember to adjust time and date settings as needed to match the local time or daylight savings time and after you replace the battery. Once you have completed a blood glucose or control solution test, the last result will appear the next time your monitor is turned on. The date and time displayed is the date and time of your previous blood sugar or control solution test result, not the current date and time.<br> 1. Press the MODE button for longer than 3 seconds. The monitor, if in Sleep Mode, wakes up, displays all segments for 3 seconds, and enters the SETUP Mode.<br> 10<br> Setting the Time, Date, and Beeper<br> This brings the monitor display to the first setup screen: time.<br> MODES<br> Hour (Flashing) Minutes (Flashing) Year (Flashing) Month (Flashing) Day (Flashing) Sample Marking (ON or OFF) Beep (ON or OFF)<br> END (End of Setup Mode)<br> 2. Repeatedly press the MODE you want to change.<br> SCREEN DISPLAY<br> “10”:00“AM” 10:”55”AM 12-28 “2006”<br> “12”-28 2006 12-”28” 2006<br> “ON” “ON” “END”<br> button to find the MODE<br> 3. Press the left/right arrow buttons to choose a new setting for that MODE.<br> 4. Press the MODE button to select the new settings or to skip to the next MODE.<br> 11<br> Running Control Solution<br> Control Solution<br> Control Solution is a liquid that contains a fixed amount of glu-cose.<br> <br> 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 blood. If the monitor reading is within the control solution’s accept-able range, the meter is working properly.<br> Perform a Control Solution Test<br> The control solution test confirms that your monitor and test strips are working correctly. A control solution test is similar to a <strong>blood glucose test</strong>, except you use Nova Max Control Solution and not a blood sample. You should run a control solution test:</li> <li>When you first get your monitor and at least once a week<br> thereafter </li> <li>Each time you open and begin using a new vial of test strips </li> <li>If you leave the test strip vial cap open for any length of time</li> <li>If the monitor is dropped, damaged, or exposed to liquids </li> <li>If you think your test results are not accurate, or if your test<br> results are not consistent with how you feel </li> <li>To check the performance of the monitor and test strips </li> <li>Nova Max High and Low Glucose Controls are also recom-<br> mended as an additional quality control check for your blood glucose monitoring system.<br> 12<br> Running Control Solution Important Information for Control Solution<br> </li> <li>Use only Nova Max Control Solution for the test. </li> <li>Check the expiration date on the control solution vial. Do not<br> use control solution past the expiration date or you may get<br> inaccurate results. </li> <li>Store only for 3 months after first opening. When you open<br> a new vial of control solution, count forward 3 months and write that date on the label of the control solution vial. Dis-card any remaining solution after the date you have written on the vial.<br> </li> <li>Store the control solution tightly closed at room temperature below 86°F (30°C). Do not refrigerate or freeze.<br> </li> <li>Shake the control solution well before using.<br> 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.<br> If your control solution test results continue to fall outside the range printed on the test strip vial:<br> </li> <li>The Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> may not be working properly. Do not use the monitor to test your blood. Call Customer Service at 1-800-681-7390.<br> 13<br> Running Control Solution Testing a Quality Control Solution<br> 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.<br> NOTE: If the strip is removed before you start the test, the screen goes blank.<br> 2. Press the left/right buttons to indicate this sample is a control. (CTL is shown on the display.)<br> NOTE: It is important to select control solution test so the test result does not appear to be one of your <strong>blood glucose test</strong> results.<br> NOTE: If a test is not performed within 2 minutes from the insertion of the test strip, the screen goes blank. To per-form a test, take out then replace the test strip starting from Step 1.<br> 3. Shake the control solution vial. Discard a drop before use. Squeeze a drop of control solution onto a clean, hard, dry surface, i.e., control cap.<br> 4. Pick up the monitor with test strip inserted and touch the test strip to the control solu-tion drop.<br> 14<br> Running Control Solution<br> 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.)<br> 5. A glucose quality control test result is available on-screen in 5 seconds. The display does a countdown from 5 to 1.<br> 6. Compare the result on the display with the range printed on the test strip vial. If the result falls within the range, your monitor and test strips are working correctly.<br> 7. The result is automatically stored into memory.<br> 8. If test result is above 600 mg/dL, the screen displays HI. If test result is below 20 mg/dL, the screen displays LO.<br> 15<br> Running Control Solution<br> Out-of-range results may be caused by the following: • An error in performing the control test, retest and follow the<br> instructions carefully. • The control solution may have expired or have been con-<br> 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.<br> </li> <li>Expired test strip -Check the expiration date on the test strip vial.</li> <li>The test strip may have been damaged. This can be caused by extreme temperature or by leaving the test strip vial cap open. Retest using a new test strip.</li> <li>Monitor malfunction -the monitor may not be working prop-erly.<br> NOTE: If the control solution test result is outside the range (is ei-ther higher or lower), your monitor and test strip may not be work-ing as a system. Repeat the process using a new test strip.<br> Do not use the monitor until test results fall within the appropriate range. If the problem continues, call toll-free, 24 hours a day, 7 days a week Customer Service at 1-800-681-7390.<br> 16<br> Running a Test<br> Running a Test<br> 1. Insert a test strip into the monitor. If monitor was off, the screen displays all segments for 2 seconds.<br> NOTE: If the strip is removed before you start the test, the screen<br> goes blank.<br> Insert this End Into Monitor<br> Apply Blood Drop Here<br> 2. After 3 seconds, the blinking blood drop symbol appears.<br> NOTE: If a test is not performed within 2 minutes from the insertion of the test strip, the screen goes blank. To perform a test, take out then replace the test strip starting from Step 1.<br> 3. Wash hands with soap and warm water then dry thoroughly. Or use alcohol pads to clean area; dry thoroughly after cleaning.<br> NOTE: Cleaning of the puncture site is important.<br> 4. Holding hand downward, massage finger with thumb toward tip to stimulate blood flow.<br> 17<br> Testing a Blood Sample<br> 5. Use a lancing device, loaded with a new lancet, to puncture the finger. (See lancing device instructions for use.)<br> 6. Squeeze the finger to form a drop of blood.<br> 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. (Beeper sounds if enabled.)<br> NOTE: The Blood Drop symbol flashes on and off repeatedly until suf-ficient blood has been added to the test strip.<br> 8. A countdown on screen appears while test is in progress. Glucose result is available on-screen in 5 seconds.<br> 9. The result is automatically stored into memory.<br> 10. Press the Left/Right buttons to move between marked (√) or unmarked results. Marked results are not included in the average test results.<br> 11. Press the Mode button to save the Marking Status: Marked (√) or Unmarked.<br> 18<br> Testing a Blood Sample<br> 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.<br> 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 marking status are saved if the monitor times out, the strip is removed, or the monitor is turned off.<br> NOTE: Lancets are for one-time use only. Use a new, sterile lancet each time you test. Test different areas on your fingertips to avoid developing calluses. Remove the used lancet from the lancing de-vice. Follow your local disposal regulations where applicable.<br> 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.<br> NOTE: Do not press the test strip directly against the skin. Touch the test strip gently to the blood drop.<br> 19<br> Testing a Blood Sample Getting and Applying a Blood Sample from Forearm or Palm<br> 1a. Select the Forearm test site in the high-lighted areas as shown.<br> NOTE: Thick hair at the sample site may cause the blood drop to smear.<br> 1b. Select the Palm Heel or Palm Side test site in the highlighted areas as shown.<br> 2. Attach the clear cap to the lanc-ing device. Press and hold the lancing device FIRMLY against the Forearm (or Palm).<br> 3. Continue to hold FIRMLY and press the release button to lance the area.<br> OR<br> Palm Side<br> Palm Heel<br> Palm Heel<br> 20<br> Testing a Blood Sample<br> 4. Continue to hold the device, pressing FIRMLY until a proper blood drop forms. The clear cap allows you to see the blood drop.<br> 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.<br> NOTE: The blood in the strip should look similar to the red blood you are accustomed to seeing when you test your finger. If the sample looks clear, pink, or light in color, retest with a fingertip sample.<br> 6. The <strong>blood glucose test</strong> result is displayed and stored. The test is complete.<br> NOTE: If you get an error message when testing on your forearm or palm or do not get a blood glucose reading after multiple attempts, test on your finger and call Customer Service toll-free, 24 hours a day, 7 days a week, in the US at 1-800-681-7390. THIS NUMBER IS NOT fOR EMERGENCy OR MEDICAL INfORMATION.<br> 21<br> Testing a Blood Sample Limitations and Considerations: Forearm and Palm Testing<br> Some patients test their blood glucose at sites other than the finger because it is generally less painful.<br> NOTE: Results from the forearm may be different from fingertip results when glucose levels are changing rapidly, e.g., after a meal, after taking insulin, or during or after exercise. Only use finger or palm testing during these times.<br> The Nova Max reduces the pain of blood glucose monitoring significantly by requiring only 0.3 μL of blood sample.<br> CAUTION: Always seek the advice of your doctor or healthcare professional before choosing to use forearm and palm sites. Bruising may occur with forearm and palm testing.<br> 22<br> Testing a Blood Sample<br> 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<br> (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<br> low (hypoglycemic) • If your forearm test results do not match the way you feel,<br> retest using your finger or palm. Consider NOT using forearm testing if you:<br> • • •<br> Are ill Are under extra stress Routinely have widely fluctuating blood glucose values that are often low (hypoglycemic)<br> Values from the palm sample were shown to be equivalent to values from the finger samples.<br> 23<br> Your Test Result<br> Your Test Result<br> Your <strong><strong>blood glucose test</strong></strong> result is displayed on the monitor.<br> 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.<br> If test result is lower than 20 mg/dL, the mon-itor displays “LO.” You may have low blood sugar. Retest your blood glucose immediate-ly using a new test strip. If your reading is still low, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.<br> If you receive an Error Message, see page 31, Displays, Meanings, Actions of this Owner’s Guide.<br> 24<br> Your Test Result<br> 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.<br> 25<br> Review Test Results in Memory<br> Review Test Results in Memory<br> NOTE: If a test strip is inserted while in the Data Review mode, the monitor immediately switches to test mode.<br> 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<br> completely blank. To turn off the monitor, hold the Mode down until the screen goes blank then release the button.<br> 1. With the monitor off, press the Mode button. The most recent test result should display. If there are NO results in memory, the screen displays 3 dashes.<br> 2. Press the Left/Right button to view all the data in memory. The Left arrow goes back in time and the Right arrow goes forward in time. All results including control results, marked results, and unmarked results can be viewed.<br> 3. At the end of reviewing individual test re-sults, the screen displays “End Mem.”<br> NOTE: For data averaging, HI results equal 600 mg/dL and LO results equal 20 mg/dL.<br> button<br> 26<br> Data Review in Memory<br> 4. To review 1 day, 7 day, 14 day, and 30 day average results, press the Mode button.<br> 5. If there are less than 2 test results in memory, the screen dis-plays 000. If no results, the screen displays 3 dashes.<br> 6. After reviewing the 30 day average, press the Mode button to shut off the monitor, or press no buttons and the monitor will turn off automatically after 30 seconds.<br> NOTE: When the monitor memory is full (400 test results), each new test result stored in memory will remove the oldest test result stored in memory.<br> 27<br> Basic Upkeep<br> Battery Check<br> 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 testing as usual; the battery indicator will remain on-screen.<br> After 20 tests have been performed, there will be insufficient bat-tery charge to continue testing, and the monitor will no longer operate until the battery is replaced. The battery icon will only appear when a strip is inserted and the icon will disappear when the strip is removed.<br> Battery low<br> 28<br> Basic Upkeep<br> Battery Replacement<br> Replace the battery as follows:<br> 1. 2.<br> 3.<br> Remove the back battery cover on the monitor.<br> Remove the battery and re-place with a new one with the + side facing up.<br> Replace the cover.<br> NOTE: After the battery is replaced, the monitor displays the all segments screen. Then, the monitor displays the time set up. Reset to the current time and date. If needed, go to page 10 in this guide to review setting the time, date, and beeper. Discard batteries according to your local environmental regulations.<br> 29<br> Basic Upkeep<br> Cleaning and Care<br> The exterior of the Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> should only be cleaned with alcohol wipes/swabs. Keep liquids from entering the test strip port or the Left, Right, and Mode buttons.<br> CAUTION: DO NOT attempt to open the monitor to make any re-pairs. Your warranty and all claims will be void! Only an authorized service personnel can repair the monitor. Call Customer Service at 1-800-681-7390 if the monitor needs to be repaired or replaced.<br> 30<br> Displays, Meanings, Actions Displays, Meanings, Actions<br> This section addresses the messages that appear on your dis-plays, what they mean, and what action you need to take.<br> Display<br> What it Means<br> System Check. Verifies that all segments are working. Appears when:<br> • Monitor is turned on for Setup and Memory Review.<br> • Test strip is inserted into the monitor.<br> Blood Drop Symbol: Monitor is ready to accept blood.<br> Countdown screen: 5-second countdown as monitor calculates the <strong>blood glucose test</strong> result.<br> A <strong>blood glucose test</strong> result in mg/dL.<br> What to Do<br> No action required. If all segments are not displayed on monitor, call Customer Service at 1-800-681-7390.<br> Apply a blood sample to the test strip. Refer to page 17, Running a Test.<br> No action required.<br> No action required. Result is automatically stored into memory.<br> 31<br> Displays, Meanings, Actions<br> Display<br> What it Means<br> Your blood glucose reading is higher than 600 mg/dL. You may have high blood sugar.<br> Your blood glucose reading is lower than 20 mg/dL. You may have low blood sugar.<br> A <strong>blood glucose test</strong> result in mg/dL stored in the monitor’s memory with date/time.<br> End of Setup or Memory Review.<br> What to Do<br> Retest your blood glucose immediately. If your reading is still HI, you should treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.<br> Retest your blood glu-cose immediately. If your reading is still LO, treat as prescribed by your healthcare professional and/or contact your healthcare professional immediately.<br> No action required.<br> No action required.<br> 32<br> Displays, Meanings, Actions<br> Display<br> What it Means<br> The average of all <strong>blood glucose test</strong> results tak-en in the last 24 hours.<br> No test results in the last 24 hours.<br> The average of all <strong>blood glucose test</strong> results taken in the last 7 days.<br> No test results in the last 7 days.<br> The average of all <strong>blood glucose test</strong> results taken in the last 14 days.<br> No test results in the last 14 days.<br> What to Do<br> No action required.<br> No action required.<br> No action required.<br> No action required.<br> No action required.<br> No action required.<br> 33<br> Displays, Meanings, Actions<br> Display<br> What it Means<br> The average of all <strong>blood glucose test</strong> results taken in the last 30 days.<br> No test results in the last 30 days.<br> There are NO results in memory.<br> Battery is getting low, but you can still perform a test. Battery will appear on all screens.<br> A control solution test result.<br> A marked sample test result.<br> What to Do<br> No action required.<br> No action required.<br> No action required.<br> We suggest that you replace the battery immediately. There is only enough power to perform 20 tests.<br> No action required.<br> No action required.<br> 34<br> Displays, Meanings, Actions<br> Display<br> What it Means<br> Software Error<br> System Hardware Error<br> Operating Temperature Error<br> Used Strip Error: Used or damaged strip.<br> Blood Sample Error<br> What to Do<br> Call Customer Service at 1-800-681-7390, 24 hours a day, 7 days a week.<br> Call Customer Service at 1-800-681-7390, 24 hours a day, 7 days a week.<br> Monitor is outside the required testing tem-perature range of 57° to 104°F (14° to 40°C). Move the monitor to a warmer or cooler area and wait a few minutes.<br> Retest with a new strip.<br> Incorrect application of blood sample or con-trol solution onto the test strip, or the test strip may be damaged. Review your sampling technique.<br> 35<br> Displays, Meanings, Actions<br> Display<br> Monitor does not turn on after inserting a test strip.<br> Monitor does not begin test countdown after apply-ing a blood sample.<br> What it Means<br> • Test strip is inserted upside down or not completely in.<br> • Battery is dead.<br> • Battery is installed in-correctly or there is no battery in the monitor.<br> • Not enough blood sample.<br> • Sample applied after monitor automatically turned off.<br> • Test strip may be damaged.<br> • Monitor may not be working properly.<br> What to Do<br> Insert the test strip correctly with the Nova name and white tip fac-ing up and out.<br> Replace the battery.<br> Check that the battery is correctly installed with the “+” sign facing you.<br> Call Customer Service 1-800-681-7390, 24 hours a day, 7 days a week.<br> Repeat the test with a new test strip.<br> Repeat the test with a new test strip.<br> Repeat the test with a new test strip.<br> After 3 attempts, call Customer Service at 1-800-681-7390, 24 hours a day, 7 days a week.<br> 36<br> Appendix<br> Specifications<br> Test Measured Glucose Methodology Glucose Test Results Sample type Glucose Test range Acceptable Hematocrit range Length of Test Test Strip Volumes Battery Life (nominal)<br> Low Battery Life Data Output Port Operating Ranges<br> Temperature<br> Humidity Weight<br> Size Monitor data storage<br> Chemistry Measurement<br> Glucose test imprecision<br> Blood Glucose Glucose oxidase biosensor mg/dL (Plasma values) Capillary whole blood 20 to 600 mg/dL 25% to 60% 5 seconds 0.3 μL 1000 Tests About 20 Tests Serial, USB<br> 57° to 104°F (14° to 40°C)<br> 10% to 90% relative humidity<br> 2.65 oz (75 g)<br> 3.6x2.3x0.9 in (91.4x58.4x22.9 mm)<br> 400 Results<br> 6% or 5.4 mg/dL (whichever is greater)<br> 37<br> Appendix<br> Limitations<br> 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<br> test newborns.<br> • Each test strip is for single use only. Do not reuse. Use a new sterile Nova Max Test Strip each time you test.<br> • Your test strips are for personal use only. DO NOT share with others.<br> • Use only fresh capillary whole blood. Do not use serum or plasma.<br> • There is no effect on blood glucose values for altitudes up to 10,000 feet (3000 meters) above sea level.<br> • Refer to the Owner’s Guide for operating temperature range for the monitor.<br> • Extremes in humidity (higher than 90% and lower than 10%) may affect results.<br> • The Nova Max Test Strips are calibrated against plasma.<br> • The anticoagulant sodium heparin may be used. EDTA is not recommended for use with Nova Max Test Strips.<br> • Interferences for elevated levels of acetaminophen, tolaza-mide, uric acid, bilirubin, ephedrine, and methyldopa may affect results.<br> 38<br> • •<br> Appendix<br> Test results may be falsely low if the patient is severely dehy-drated.<br> Critically ill patients should not be tested with home blood glucose monitors.<br> 39<br> Appendix<br> Instructional Notes<br> 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.<br> 2. If in Data Review mode when the test strip is inserted, the monitor immediately switches to test mode. Upon exiting test mode the monitor screen goes blank and does not return to Data review mode.<br> 3. Battery low icon is displayed in every mode except setup.<br> 4. Once battery level goes below the threshold that triggers the “low battery” warning, it continues to give the warning until the monitor becomes unusable due to low battery.<br> 5. The Monitor responds to the pressing and the holding of keys:<br> Left/Right buttons<br> - The Left/Right button moves forward/backward through a series of stored test result screens or increments of value.<br> - Hold down the Left/Right button to speed up screen change process.<br> MODE button<br> - When the MODE button is pressed less than 1.5 seconds to advance to the next function, the monitor advances to next screen immediately when button is pressed.<br> 40<br> Appendix<br> - 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.<br> - While monitor is in sleep mode (OFF), pressing the MODE button greater than 3.0 seconds wakes up the monitor and enters setup mode.<br> - While monitor is awake (ON), pressing the MODE button greater than 1.5 seconds manually turns off the monitor (sleep mode).<br> 6. With no activity, time-out occurs after the following times: - 1 minute for all screens - 2 minutes during test mode - 3 minutes when download connector inserted<br> 41<br> Appendix<br> Warranty<br> Your Nova Max <a href="https://storefront.novacares.com/storefront/">Blood Glucose Monitor</a> 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 as described below), it will be replaced with a new monitor, or a substantial equivalent, free of charge.<br> Limitations on Warranty: This warranty is subject to the following exceptions and limitations: 1. This warranty is applicable only to the original purchaser. 2. This warranty does not apply to units which malfunction or are dam-<br> aged due to obvious abuse, misuse, alteration, neglect, unauthor-ized maintenance or failure to operate meter in accordance with instructions.<br> 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.<br> 4. There is no other express warranty for this product. The option of replacement, described above, is the warrantor’s only obligation under this warranty.<br> For warranty service: The original purchaser must contact Nova Cus-tomer Service by calling toll-free at 1-800-681-7390. Privacy Policy: Both Nova, as manufacture </div> </div> <div class="product-tabs-content" id="product_tabs_additional_contents"> <h2>Additional Information</h2> <table class="data-table" id="product-attribute-specs-table"> <col width="25%" /> <col /> <tbody> <tr> <th class="label">Free Shipping</th> <td class="data">N/A</td> </tr> </tbody> </table> <script type="text/javascript">decorateTable('product-attribute-specs-table')</script> </div> <script type="text/javascript"> //<![CDATA[ Varien.Tabs = Class.create(); Varien.Tabs.prototype = { initialize: function(selector) { var self=this; $$(selector+' a').each(this.initTab.bind(this)); }, initTab: function(el) { el.href = 'javascript:void(0)'; if ($(el.parentNode).hasClassName('active')) { this.showContent(el); } el.observe('click', this.showContent.bind(this, el)); }, showContent: function(a) { var li = $(a.parentNode), ul = $(li.parentNode); ul.select('li', 'ol').each(function(el){ var contents = $(el.id+'_contents'); if (el==li) { el.addClassName('active'); contents.show(); } else { el.removeClassName('active'); contents.hide(); } }); } } new Varien.Tabs('.product-tabs'); //]]> </script> </div> </div> <script type="text/javascript"> var lifetime = 3600; var expireAt = Mage.Cookies.expires; if (lifetime > 0) { expireAt = new Date(); expireAt.setTime(expireAt.getTime() + lifetime * 1000); } Mage.Cookies.set('external_no_cache', 1, expireAt); </script> </div> </div> <div class="bottom-container col4-set"> <div class="col-1"> <h2>Contact Us</h2> Call our Customer Support Line: <a href="tel:8006817390" class="phones"><strong>(800) 681-7390</strong></a> <a href="mailto:ncc@novacares.com">Email</a> </div> <div class="col-2"> <h2>About Us</h2> <p>Nova Diabetes Care is a subsidiary of <a href="http://www.novabiomedical.com" target="_blank">Nova Biomedical<sup>®</sup></a>. 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