Nova Max Link Manuel utilisateur
Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.
Telephone: 1-800-681-7390
Web site: www.novamaxlink.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 Link is a trademark of Nova Biomedical.
Copyright 2007 Nova Biomedical Corporation
44619 Rev A 12/2007
Nova Max Link™ Blood Glucose Monitor Owner’s Guide
Nova thanks you for choosing the Nova Max Link™ 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 Link Blood Glucose Monitor is designed to be con-
venient and easy to use. The Nova Max Link is designed for wire-
less communication with Paradigm® Model 512, 712, or higher
insulin infusion pumps. 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.
Important Information!
• 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 34) to install a new battery.
THANK YOU
• 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).
For the Blood Glucose Monitor with radio frequency (RF) turned on:
This device complies with the United States Federal Commu-
nications Commission and international standards for Electro-
magnetic Compatibility regarding its use.
This device complies with Part 15 of the FCC rules. Operation is
subject to the following 2 conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including
interference that may cause undesirable operation.
These standards are designed to provide reasonable protection
against excessive radio frequency interference and prevent un-
desirable operation of the device from unwanted electromagnet-
ic interference. Operation is subject to the following 2 conditions:
1. This device has been tested and found to comply with the
regulations governing such devices in your area. Please con-
tact Nova at 1-800-681-7390.
Important Information!
2. This device generates, uses, and can radiate radio frequency
energy and, if installed and used in accordance with the
instruction, may cause harmful interference to radio com-
munications. If the device does cause interference to radio or
television communications. If the device does cause inter-
ference to radio or television communications, the user is
encouraged to try to correct the interference by one or more
of the following measures:
• Reorient or relocate the blood glucose monitor.
• Increase the separation between the blood glucose moni-
tor and the device that is receiving/emitting interference.
• If you have questions, please contact Nova at 1-800-681-
7390.
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
Monitor Components ......................................................................................3
Introduction ........................................................................................................4
Monitor Display..............................................................................................4
The Nova Max Link 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
Talking to Your Pump................................................................................ 10
Setting the Time, Date, and Beeper......................................................... 11
Using the Send (Snd) Function.............................................................. 13
Setting the Send Function ...................................................................... 13
Running Control Solution ........................................................................... 14
Control Solution.......................................................................................... 14
Perform a Control Solution Test ............................................................ 14
Important Information for Control Solution..................................... 15
Testing a Quality Control Solution ....................................................... 16
Running a Test ................................................................................................ 19
TOC-1
Getting and Applying a Blood Sample from Forearm or Palm .. 23
Limitations and Considerations: Forearm and Palm Testing ...... 25
Your Test Result ............................................................................................... 27
Sending a Blood Glucose Result to Your Paradigm Model 512,
712, or Higher Insulin Pump............................................................... 28
Marking a Single Blood Glucose Test So It Is Not Sent to Your
Paradigm Model 512, 712, or Higher Insulin Pump ................... 30
Review Test Results in Memory................................................................. 31
Basic Upkeep.................................................................................................... 33
Battery Check............................................................................................... 33
Battery Replacement................................................................................. 34
Cleaning and Care...................................................................................... 35
Displays, Meanings, Actions ................................................................... 36
Appendix........................................................................................................... 43
Specications............................................................................................... 43
Chemistry Measurement......................................................................... 43
Limitations.................................................................................................... 44
Instructional Notes .................................................................................... 46
Warranty ............................................................................................................ 48
TOC-2
1
The Nova Max Link 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 eectiveness of diabetes
control. The Nova Max Link Blood Glucose Monitor is specically
indicated for the quantitative measurement of glucose in whole
blood capillary samples obtained from the ngertip, palm and
forearm.
• The Nova Max Link 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 Link 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 Link Blood Glucose Monitor.
In vitro diagnostic medical device
Caution, consult accompanying documents
Consult instructions for use
Biological risk
Catalog number
Temperature limitation
(((•))) Rf emitter
Symbols
3
Nova Max Link Blood Glucose Monitor
LCD Display
Left Arrow
Button
Mode
Button
Right Arrow
Button
Test Strip
Goes Here
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 Link Monitor Screen
Introduction
Monitor Display
When you turn the Nova Max Link Blood Glucose Monitor on,
the all segments display appears briey. This tells you that all the
display segments are working properly.
Hour/Minute
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