Nova Max PLUS User manual

KET
KET
GLU
GLU
También
Mide
Cetonas
Sistema de
monitoreo de
Glucosa y
ß-Cetonas
en sangre
Also
Measures
Ketones
OWNER’S GUIDE
GUÍA DEL
PROPIETARIO

Nova Biomedical Corporation
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Inside the USA call Customer Service toll free.
Telephone: [phone]
or visit our Web site: www.novacares.com
Outside the USA, contact your Nova supplier.
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, CA 2,375,092, EP 1 497 446, EP 1 497 449,
JP 4060078, and other U.S. and foreign patents pending.
Nova Max is a registered trademark of Nova Biomedical.
Copyright 2012 Nova Biomedical Corporation
46171 Rev D 2012-09
Nova Max®Plus Glucose and ß-Ketone Monitoring
System Owner’s Guide
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Nova thanks you for choosing the Nova Max Plus Glucose and
ß-Ketone Monitoring System. This Owner’s Guide contains impor-
tant information on the monitor and how it works. Please read it
carefully before using your new monitor.
The Nova Max Plus Monitor is designed to be convenient and
easy to use. It gives accurate results in just 5 seconds (for glucose)
or 10 seconds (for ß-ketone) 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 Glucose or ß-Ketone test. The
monitor also has memory that stores your Glucose or ß-Ketone
test results to help you and your healthcare professional manage
your diabetes, including diabetic ketoacidosis (DKA).
Before you get started, it is important to complete the Warranty
Registration Card included in your kit and mail it back to Nova. Or
complete the warranty card on www.novacares.com. 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 USA at 1-800-681-7390 or visit our
website at www.novacares.com.
Outside the USA, contact your Nova supplier.
Privacy Policy: Nova Biomedical, as the manufacturer the Nova Max
Plus Monitor, is committed to using your personal information respon-
sibly and in compliance with the law. You have our pledge that we will
not share or sell your personal information with marketers or third-par-
ties. The information you voluntarily share with us will be used to help
us serve you better in the future.
THANK YOU
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• BeforeyoubeginusingyournewNovaMaxPlus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 38) 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 or ß-ketone monitor-
ing routine.
• Therecommendationsinthismanualapplytoallbloodglu-
cose and ß-ketone monitors and are supported by the Ameri-
can Association of Diabetes Educators (AADE), the American
Diabetes Association (ADA), the US Food and Drug Administra-
tion (FDA), and the Advanced Medical Technology Association
(AdvaMed).
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 Safety Instructions!
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Table of Contents
Intended Use.......................................................................................................1
Symbols ................................................................................................................2
Introduction ........................................................................................................3
Monitor Components ..................................................................................3
Monitor Display..............................................................................................4
The Nova Max Plus Glucose and ß-Ketone 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
Glucose Test Strips ........................................................................................8
Important Nova Max Glucose Test Strip Information.......................8
Ketone Test Strips..........................................................................................9
Important Nova Max Ketone Test Strip Information.........................9
Lancing Device............................................................................................ 10
Setting the Time, Date, and Beeper......................................................... 11
Running Control Solution ........................................................................... 13
Control Solution.......................................................................................... 13
Perform a Control Solution Test ............................................................ 13
TOC-1
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Running Glucose Control Solution .......................................................... 14
Testing a Glucose Quality Control Solution...................................... 15
Running Glucose a Test ............................................................................... 18
Blood Sample (Glucose Only) from Forearm or Palm.................... 21
Limitations and Considerations: Forearm and Palm Testing ...... 23
Your Glucose Test Results ........................................................................ 25
Ketone Test Alert: Glucose Value 250 mg/dL or Higher................ 26
Running ß-Ketone Control Solution........................................................ 27
Testing a ß-Ketone Quality Control Solution.................................... 28
Running a ß-Ketone Test ............................................................................. 31
Your ß-Ketone Test Results...................................................................... 34
Review Test Results in Memory ............................................................. 35
Basic Upkeep.................................................................................................... 37
Battery Check............................................................................................... 37
Battery Replacement................................................................................. 38
Cleaning and Care...................................................................................... 39
Displays, Meanings, Actions....................................................................... 40
Appendix........................................................................................................... 47
Specications............................................................................................... 47
Chemistry Measurement......................................................................... 48
Limitations.................................................................................................... 48
Instructional Notes .................................................................................... 49
Warranty ........................................................................................................ 51
TOC-2
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1
The Nova Max Plus Glucose and ß-Ketone Monitoring System
isintendedtobeusedforthequantitativemeasurementof
glucose or ß-hydroxybutyrate (ß-Ketone) in fresh capillary whole
blood. It is intended for use by people with diabetes mellitus in
the home and by healthcare professionals in clinical settings as
an aid to monitor the eectiveness of diabetes control. It is not
intended for use in the diagnosis of or screening for diabetes
mellitus and is not intended for use on neonates. The Nova
MaxPlusMonitorisspecicallyindicatedforthequantitative
measurement of glucose in fresh capillary whole blood samples
obtained from the ngertip, forearm, and palm or ß-ketone in
fresh capillary whole blood samples obtained from the ngertip
only.
• TheNovaMaxPlusMonitorisintendedforuseoutsidethe
body (in vitro diagnostic use).
• ItshouldonlybeusedwithNovaMaxPlusGlucoseandß-
Ketone Test Strips and Nova Max Plus Control Solutions.
• Itshouldbeusedfortestingglucose(sugar)andß-Ketone
only with fresh capillary whole blood samples.
• ItshouldNOT be used to diagnose DKA or to test newborns.
• ItshouldNOT be stored in the refrigerator or in the car.
WARNING: The Nova Max Plus 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
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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 or ß-ketone, 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 Plus Monitor.
In vitro diagnostic medical device
Caution, consult accompanying documents
Consult instructions for use
Biological risk
Catalog number
Temperature limitation
Symbols
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3
Nova Max Plus Glucose and ß-Ketone Monitor
LCD Display
Left Arrow
Button
Mode
Button
Right Arrow
Button
Test Strip
Goes Here
Introduction
Monitor Components
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4
Marked Test
Results
Memory Result
Blood or Control
Drop Indicator
Control
Low Battery
Indicator
Test Results
mg/dl or mmol/L
Average Test
Results
AM or PM
Indicator
Date/Day
Nova Max Plus Glucose and ß-Ketone Monitor Screen
Introduction
Monitor Display
When you turn the Nova Max Plus
Monitor on, the all segments display
appears briey. This tells you that all
the display segments are working
properly.
Hour/Minute
Ketone
Glucose
Remove before use
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5
Introduction
The Nova Max Plus Glucose and ß-Ketone Monitor
The monitor is a hand-held testing device that measures glucose
(sugar) in capillary whole blood and ß-ketone in capillary whole
blood. The test strip is touched to a drop of blood to initiate the
test process. The monitor activates after a Nova Max Plus test strip
is inserted. The screen displays“Glu”or“Ket,”depending on which
type of Nova Max Strip is inserted. The blue strip measures blood
glucose levels, and the green strip measures ß-ketone levels.
• Asimpleone-stepprocessprovidesaresult.
• Testresultsareavailablein5(Glu)or10(Ket)seconds.
• Thereismemoryforonecommonuser’ssetoftestresults(400).
• Themonitorispoweredbyabatterythatcanperform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, and extreme temperatures.
Overview
To perform a test, the operator simply inserts a test strip; waits for
the blood drop symbol to appear on the screen (“Glu”or“Ket”also
appears - the meter is ready); brings the test strip to the drop of
blood; and obtains a test result in 5 (Glu) or 10 (Ket) seconds. The test
result is automatically stored into the monitor’s memory. The opera-
tor can recall and review test data stored in the monitor.
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6
Kit Contents*
1. Nova Max Plus Monitor
2. Vial of Nova Max Plus Glucose Test Strips (10)*
3. Lancing device*
4. Lancets*
5. Nova Max 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. Two Ketone Test Strips*
12. Carry Case
* Contents are not the same for each kit. Your Nova
Max Plus Kit may not have all the items listed
above, Consult the Nova Max Plus monitor pack-
age for complete contents.
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
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7
Introduction
Before Testing
Before testing and to ensure accurate results, wash your hands
and the testing site then thoroughly dry these areas.
The Nova Max Plus Monitor can test your blood glucose on the
ngers, forearm, or palm. The Nova Max Plus Monitor can test
your blood ß-ketone on the ngers only.
The sample size is just 0.3 µL (Glu) or 0.8 µL (Ket) 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 or ß-ketone test results and you have fol-
lowed all instructions described in the Owner’s Guide, call your
doctor or healthcare professional.
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8
Introduction
Glucose Test Strips
The Nova Max Glucose Test Strips are designed for use with your
Nova Max Plus 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(glucose)
• Automaticallydrawsbloodintothetestareaofthestrip
• Canbehandledwithclean,dryhandswithoutaecting
readings
Important Nova Max Glucose Test Strip Information
• UseonlyNovaMaxGlucoseTestStripswhentestingfor
glucose.
• 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
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9
• Teststripsshouldonlybestoredfor6monthsafteropening
the vial. When rst opening a new vial of test strips, count
forward 6 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
strips and vial away from children and pets.
Ketone Test Strips
The Nova Max Ketone Strips are designed for use with your
Nova Max Plus Monitor only. Use each test strip only once, then
discard. DO NOT reapply blood to the test strip.
• Requiresaverysmallbloodvolume:0.8µL(ketone)
• Automaticallydrawsbloodintothetestareaofthestrip
• Canbehandledwithclean,dryhandswithoutaecting
readings
Important Nova Max Ketone Test Strip Information
• UseonlyNovaMaxß-KetoneTestStripswhentestingfor
ketone.
• Removetheteststripfromthefoilonlywhenreadytotest.
Apply Blood
Drop to Front
Edge
Insert This
End Into
Monitor
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10
• 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packagingonly.
• Donotuseteststripsbeyondtheexpirationdateprintedon
the package as this may cause inaccurate results.
• Donottamperwiththeteststrip.
WARNING: The test strip packaging contains small parts. Keep the
test strips and packaging 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.
Depth Adjustment
Release Button
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11
Setting the Time, Date, and Beeper
Having the correct time and date of each blood 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.
Your Nova Max Plus Monitor oers a beeper function that is pre-
set“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 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 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.
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12
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“2009”
Month (Flashing) “12”-28 2009
Day (Flashing) 12-”28”2009
Beep (ON or OFF) “ON”
Sample Marking (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.
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13
Control Solution
ControlSolutionisaliquidthatcontainsaxedamountofGlu-
cose or ß-ketone.
• Usethesesolutionstoverify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 acceptable
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 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 for glucose
• Eachtimeyouopenandbeginusinganewvialofglucoseteststrips
• Ifyouleavetheglucose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andNovaMaxPlusß-Ke-
tone Low and High Controls are also recommended as an additional
qualitycontrolcheckforyourNovaMaxPlusmonitoringsystem.
Running Control Solution
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