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

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availablein5seconds.
• Thereismemoryforonecommonuser’ssetoftestresults
(400).
• Themonitorispoweredbyabatterythatcanperformforap-
proximately 1000 tests.
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 frommoisture,prolonged
direct sunlight,andextreme temperatures.
Overview
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.

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. Getting Started Poster
* These items are not included in the mail order ver-
sion of the monitor.
Environmental
• Thestoragetemperaturerangeforthemonitor:-13°Fto115°F
(-25°Cto46°C)
• ThestoragetemperaturerangefortheTestStrips:59°Fto86°F
(15°Cto30°C)
• Themonitoroperationaltemperaturerange:57°Fto104°F(14°C
to40°C)
• Therelativehumidityrange:10%to90%non-condensing
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 ngers, forearm, or palm.
The sample size is just 0.3 µL of blood.
Reasons to Check for Low Blood Glucose
• 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.
Important Health Related Information
If you are experiencing symptoms that are not consistent with
your blood glucose test results and you have followed all instruc-
tions described in the Owner’s Guide, call your doctor or health-
care professional.

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thestrip
• Canbehandledwithclean,dryhandswithoutaectingglu-
cose readings
Important Nova Max Test Strip Information
• 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
(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
the vial cap and close tightly.
• Donotuseteststripsbeyondtheexpirationdateprintedon
the package as this may cause inaccurate results.
Apply Blood
Drop to Front
Edge
Insert This
End Into
Monitor

9
• Teststripsshouldonlybestoredfor3monthsafteropening
the vial. When rst opening a new vial of test strips, count
forward 3 months and write that date on the vial. Discard any
remaining test strips after the date you have written on the
vial.
• Donottamperwiththeteststrip.
WARNING: The test strip vial contains small parts. Keep the test
strip vial away from children and pets.
Lancing Device
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.
Introduction
Depth Adjustment
Release Button Force Adjustment

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 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.
YourNovaMaxBloodGlucoseMonitoroers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.
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.
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.

11
This brings the monitor display to the rst
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) “ON”
Beep (ON or OFF) “ON”
END (End of Setup Mode) “END”
2. Repeatedly press the MODE button to nd the MODE
you want to change.
3. Press the left/right arrow buttons to choose a
new setting for that MODE.
4. Press the MODE button to select the new settings or to
skip to the next MODE.

12
Control Solution
ControlSolutionisaliquidthatcontainsaxed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 blood.
• Ifthemonitorreadingiswithinthecontrolsolution’saccept-
able range, the meter is working properly.
Perform a Control Solution Test
The control solution test conrms that your monitor and test
strips are working correctly. A control solution test is similar to
a blood glucose test, except you use Nova Max Control Solution
and not a blood sample.
Youshouldrunacontrolsolutiontest:
• Whenyourstgetyourmonitorandatleastonceaweek
thereafter
• Eachtimeyouopenandbeginusinganewvialofteststrips
• Ifyouleavetheteststripvialcapopenforanylengthoftime
• Ifthemonitorisdropped,damaged,orexposedtoliquids
• Ifyouthinkyourtestresultsarenotaccurate,orifyourtest
results are not consistent with how you feel
• Tochecktheperformanceofthemonitorandteststrips
• NovaMaxHighandLowGlucoseControlsarealsorecom-
mendedasanadditionalqualitycontrolcheckforyourblood
glucose monitoring system.
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rstopening.Whenyouopen
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.
• Storethecontrolsolutiontightlyclosedatroomtemperature
below86°F(30°C).Donotrefrigerateorfreeze.
• Shakethecontrolsolutionwellbeforeusing.
Caution: The Nova Max Control Solution range printed on the test
strip vial is for control solution only. It is used to test the perfor-
mance of the monitor and test strip. It is not a recommended range
for your blood glucose level.
If your control solution test results continue to fall outside the
range printed on the test strip vial:
• TheNovaMaxBloodGlucoseMonitormaynotbeworking
properly.
• Donotusethemonitortotestyourblood.
• CallCustomerServiceat1-800-681-7390.
Running Control Solution

14
Testing a Quality Control Solution
1. Insert a test strip into the monitor. If monitor was o, 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 buttons to indicate this
sample is a control. (CTL is shown on the display.)
NOTE: It is important to select control solution test so the test result
does not appear to be one of your blood glucose test results.
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.
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.
4. Pick up the monitor with test strip inserted
and touch the test strip to the control solu-
tion drop.
Running Control Solution