Nova Max User manual

Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Telephone: [phone]
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 trademark of Nova Biomedical.
Copyright 2007 Nova Biomedical Corporation
40677 Rev E 05/2009
Nova Max®Blood Glucose Monitor Owner’s Guide

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 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.
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.
THANK YOU

• BeforeyoubeginusingyournewBloodGlucoseMonitor,
please read all of the instructions provided in this Owner’s
Guide.
• YourmonitorusesaCR24503-voltcoincellbattery.Tobegin
using your monitor, you need to install the enclosed battery.
See Battery Replacement (page 29) to install a new battery.
• Performallqualitycontrolchecksrecommendedinyour
Owner’s Guide.
• Consultwithyourdiabeteshealthcareprofessionalandfollow
his/her guidance for your blood glucose monitoring routine.
• 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).
Notes, Cautions, and Warnings:
NOTES provide helpful operating information.
CAUTIONS provide information that is important for instrument
protection.
WARNINGS provide information that is important for user protec-
tion or about risk for inaccurate results.
Important Information!

Table of Contents
Intended Use.......................................................................................................1
Symbols ................................................................................................................2
Introduction ........................................................................................................3
Monitor Components ..................................................................................3
Monitor Display..............................................................................................4
The Nova Max Blood Glucose Monitor..................................................5
Overview ..........................................................................................................5
Kit Contents.....................................................................................................6
Environmental................................................................................................6
Before Testing .................................................................................................7
Reasons to Check for Low Blood Glucose.............................................7
Important Health Related Information..................................................7
Test Strips .........................................................................................................8
Important Nova Max Test Strip Information........................................8
Lancing Device...............................................................................................9
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
TOC-1

Basic Upkeep.................................................................................................... 28
Battery Check............................................................................................... 28
Battery Replacement................................................................................. 29
Cleaning and Care...................................................................................... 30
Displays, Meanings, Actions.......................................................................31
Appendix........................................................................................................... 37
Specications............................................................................................... 37
Chemistry Measurement......................................................................... 37
Limitations.................................................................................................... 38
Instructional Notes .................................................................................... 40
Warranty ........................................................................................................ 42
TOC-2

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 eectiveness of diabetes con-
trol. The Nova Max Blood Glucose Monitor is specically indicat-
edforthequantitativemeasurementofglucoseinwholeblood
capillary samples obtained from the ngertip, palm and forearm.
• TheNovaMaxBloodGlucoseMonitorisintendedforuse
outside the body (in vitro diagnostic use).
• ItshouldonlybeusedwithNovaMaxTestStripsandNova
Max Control Solution.
• Itshouldbeusedfortestingglucose(sugar)andonlywith
fresh capillary whole blood samples.
• ItshouldNOT be used to diagnose diabetes or to test new-
borns.
• ItshouldNOT be stored in the refrigerator or in the car.
WARNING: The Nova Max Blood Glucose Monitor 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.
Intended Use

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 be disposed of in accordance to local regulations to
avoid risk to anyone.
Symbols
The following are symbols that are used in this manual, on insert
sheets, and on the Nova Max Blood Glucose Monitor.
In vitro diagnostic medical device
Caution, consult accompanying documents
Consult instructions for use
Biological risk
Catalog number
Temperature limitation
Symbols

3
Nova Max Blood Glucose Monitor
LCD Display
Left Arrow
Button
Mode
Button
Right Arrow
Button
Test Strip
Goes Here
Introduction
Monitor Components

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 display appears briey. This tells you that all the dis-
play segments are working properly.
Hour/Minute