Nova Max PLUS Manual de usuario
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: 1-800-681-7390
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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• BeforeyoubeginusingyournewNovaMaxPlusMonitor,
please read all of the instructions provided in this Owner’s
Guide.
• YourmonitorusesaCR24503-voltcoincellbattery.Tobegin
using your monitor, you need to install the enclosed battery.
See Battery Replacement (page 38) to install a new battery.
• Performallqualitycontrolchecksrecommendedinyour
Owner’s Guide.
• Consultwithyourdiabeteshealthcareprofessionalandfollow
his/her guidance for your blood glucose or ß-ketone monitor-
ing routine.
• Therecommendationsinthismanualapplytoallbloodglu-
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!
Nova Max Plus Monitor OG PN46171D1 EN.indd 3 9/5/12 3:22 PM
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
Specications............................................................................................... 47
Chemistry Measurement......................................................................... 48
Limitations.................................................................................................... 48
Instructional Notes .................................................................................... 49
Warranty ........................................................................................................ 51
TOC-2
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Nova Max Plus Monitor OG PN46171D1 EN.indd 6 9/5/12 3:22 PM
1
The Nova Max Plus Glucose and ß-Ketone Monitoring System
isintendedtobeusedforthequantitativemeasurementof
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 eectiveness 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
MaxPlusMonitorisspecicallyindicatedforthequantitative
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.
• TheNovaMaxPlusMonitorisintendedforuseoutsidethe
body (in vitro diagnostic use).
• ItshouldonlybeusedwithNovaMaxPlusGlucoseandß-
Ketone Test Strips and Nova Max Plus Control Solutions.
• Itshouldbeusedfortestingglucose(sugar)andß-Ketone
only with fresh capillary whole blood samples.
• ItshouldNOT be used to diagnose DKA or to test newborns.
• ItshouldNOT 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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