Nova Max Link Owner's Manual
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 using your new monitor.
The Nova Max Link Blood Glucose Monitor is designed to be convenient and easy to use. The Nova Max Link is designed for wireless 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 professional 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 website 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 Electromagnetic 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 undesirable operation of the device from unwanted electromagnetic 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 contact 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 communications. If the device does cause interference to radio or
television communications. If the device does cause interference 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 protection 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 newborns.
• 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 monitor 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 potential 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
5
Introduction
The Nova Max Link 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 approximately 500 tests when the “Snd” function is on.
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 from moisture, 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; 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 monitor’s memory. The operator can recall, delete, and review test
data stored in the monitor, including the average for user results.
6
Kit Contents
1. Nova Max Link™ Blood Glucose Monitor
2. Lancing device*
3. Nova Max™ Blood Glucose Control Solution,
Normal (1 bottle)*
4. Lancets (10)*
5. Day Case
6. Battery (CR2450, 3V)
7. Owner’s Guide
8. Quick Reference Guide
9. Getting Started Poster
10. Warranty Card
11. Clear Cap and Instructions for Forearm and Palm
Testing
* 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 Link Blood Glucose Monitor can test your blood
glucose 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 instructions described in the Owner’s Guide, call your doctor or healthcare professional.
8
Introduction
Test Strips
The Nova Max Test Strips are designed for use with your Nova
Max Link Blood Glucose Monitor. 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 aecting glucose 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.
Introduction
Depth Adjustment
Release Button
Force Adjustment
10
Introduction
Talking to Your Pump
Your Nova Max Link Blood Glucose Monitor arrives with its “Snd”
function already turned on. Every time the meter displays a new
blood glucose test result, the meter automatically sends the
result to the your Paradigm® Model 512, 712, or higher insulin
pump. However, your pump will only listen for a blood glucose
test result if you have programmed the pump with the meter’s ID
number. The pump will accept up to 3 dierent meter ID numbers. The Nova Max Link is designed to communicate with the
Paradigm Model 512, 712, or higher insulin pump. Please refer
to your Paradigm Model 512, 712, or higher insulin pump User
Guide or the Getting Started poster to see how to program your
meter’s ID number into the pump.
11
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 Link Blood Glucose Monitor oers 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.
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