Nova Max Link Owner's Manual

Nova Biomedical
200 Prospect Street
Waltham, MA 02454-9141 U.S.A.

Telephone: [phone]
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

Specications ............................................................................................... 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 eectiveness of diabetes
control. The Nova Max Link Blood Glucose Monitor is specically
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 briey. 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 aecting 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 dierent 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 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.

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) 1-28 “2008”
Month (Flashing) “1”-28 2008

Day (Flashing) 1-”28” 2008
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.

13

Using the Send (Snd) Function

Your Nova Max Link Blood Glucose Monitor has a send function.
The Send Function allows you to turn on or o sending blood
glucose results to your Paradigm Model 512, 712, or higher insu­lin pump.

NOTE: The “Snd” function is turned on when you receive your monitor.

Setting the Send Function

The monitor is o, with no test strip inserted in the test strip slot.

1. Begin Setup: Press and continue to hold the Mode
button. You will hear 2 short beeps and see “Snd” and the
word “On.” Release the Mode button.

NOTE: If you release the Mode button too soon, turn o your
monitor by pressing and holding the Mode button. Repeat Step 1.

2. Set glucose test result transfer to insulin pump. The glucose
test result transfer to insulin pump is preset to “On.” Press the
left/right arrow buttons to select the setting
“On” or O.”

3. Press the Mode button briey to conrm your choice
and to advance to set insulin recording function.

14

Running Control Solution

Control Solution

Control Solution is a liquid that contains a xed amount of glu­cose.

• Use this solution to test that your monitor with test strip is
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 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 recom­mended as an additional quality control check for your blood
glucose monitoring system.

15

Important Information for Control Solution

• Use only the 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. Dis­card 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 perfor­mance 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 Link 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

16

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 move between
unmarked sample or marked control sample (CTL); select
control.

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.

CAUTION: It is important to mark a control solution test prior to ap­plying blood to the test strip, so the test result does not appear to be
one of your blood glucose test results, and also to prevent it from be­ing included in your blood glucose average. Also, this will prevent the
meter from sending a control solution test result to your Paradigm
Model 512, 712, or higher insulin pump.

NOTE: If a test is not performed within 2 minutes from the insertion
of the test strip, the screen goes blank. To perform 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.

Running Control Solution

17

Running Control Solution

4. Pick up the monitor with test strip inserted
and touch the test strip to the control solu­tion drop.

NOTE: The on-screen Control Symbol ashes on
and o repeatedly until sucient control solution
has been added to the test strip. (Beeper sounds if enabled.)

5. A glucose quality control test result is available on-screen in 5
seconds. The display does a countdown from 5 to 1.

6. Compare the result on the display with the range printed
on the test strip vial. If the result falls within the range, your
monitor and test strips are working correctly.

7. The result is automatically stored into memory.

8. If test result is above 600 mg/dL, the screen displays HI; test
result cannot be stored.

If test result is below 20 mg/dL, the screen displays LO; test

result cannot be stored.

NOTE: Results that are marked as control solution will not ash
because they are not sent to your pump.

18

Running Control Solution

Out-of-range results may be caused by the following:

• An error in performing the control test, retest and follow the
instructions carefully.

• The control solution may have expired or have been con­taminated. Check the expiration date on the control solution
vial. Control solution is good for only 3 months after opening.
Make sure the control solution vial is closed when not in use.

• Expired test strip - Check the expiration date on the test strip
vial.

• The test strip may have been damaged. This can be caused
by extreme temperature or by leaving the test strip vial cap
open. Retest using a new test strip.

• Monitor malfunction - the monitor may not be working prop­erly.

NOTE: If the control solution test result is outside the range (is ei­ther higher or lower), your monitor and test strip may not be work­ing as a system. Repeat the process using a new test strip.

Do not use the monitor until test results fall within the appropriate
range. If the problem continues, call toll-free, 24 hours a day, 7 days
a week Customer Service at 1-800-681-7390.

19

Running a Test

1. Insert a test strip into the monitor. If monitor was o, the
screen displays all segments for 2 seconds.

NOTE: If the strip is removed before you start the test, the screen
goes blank.

2. After 3 seconds, the blinking blood drop symbol appears.

NOTE: If a test is not performed within 2 minutes from the insertion
of the test strip, the screen goes blank. To perform a test, take out
then replace the test strip starting from Step 1.

3. Wash hands with soap and warm water then dry thoroughly. Or
use alcohol pads to clean area; dry thoroughly after cleaning.

NOTE: Cleaning of the puncture site is important.

4. Holding hand downward, massage nger with thumb toward
tip to stimulate blood ow.

Apply Blood
Drop Here

Insert this
End Into
Monitor

20

Testing a Blood Sample

5. Use the lancing device, loaded with a new
lancet, to puncture the nger. (See lancing
device instructions for use.)

6. Squeeze the nger to form a drop of blood.

7. Touch the end of the test strip to the blood
drop until the test strip is full and the on­screen countdown timer begins.

(Beeper sounds if enabled.)

NOTE: The Blood Drop symbol ashes on and o repeatedly until suf­cient blood has been added to the test strip.

8. A countdown on screen appears while test is in progress.
Glucose result is available on-screen in 5 seconds.

9. The result is automatically stored into memory.

NOTE: The glucose result will ash while the monitor is transmit­ting the glucose result to the insulin pump. Removing the strip will
not automatically turn o the monitor while Rf transmission is in
progress (ashing). You can stop the transmission by manually
turning o the monitor or inserting a new test strip. The glucose
result will stop ashing (transmitting) when the pump receives the
glucose result or after 60 seconds.

21

Testing a Blood Sample

NOTE: Your monitor arrives from the factory with “Snd” set to “On.”
If the glucose result does not ash and the insulin pump does not
receive the glucose result, then set “Snd” to “On.”

10. Press the Left/Right

buttons
to move between marked (√) or unmarked
results. Marked results are not included into
the average test results. Hi, Lo, and Control
results are not included into the average.

11. Press the Mode button to save the Marking Status:
Marked (√) or Unmarked.

12. If test result is above 600 mg/dL, the screen displays HI; test
result cannot be stored.

If test result is below 20 mg/dL, the screen displays LO; test

result cannot be stored.

NOTE: The monitor will time out after 2 minutes of non-use or if
the strip is removed. The keys are disabled until a strip is inserted.
Results and marking status are saved if the monitor times out, the
strip is removed, or the monitor is turned o.

NOTE: Lancets are for one-time use only. Use a new, sterile lancet
each time you test. Test dierent areas on your ngertips to avoid
developing calluses. Remove the used lancet from the lancing de­vice. Follow your local disposal regulations where applicable.

22

WARNING: Your lancing device is for your personal use only. DO
NOT share with others. Sharing the lancing device or lancets can
transmit serious, even grave infections. To avoid accidental sticks,
do not store used lancets in the device after testing or arm the lanc­ing device with a new sterile lancet unless ready to use.

NOTE: Do not press the test strip directly against the skin. Touch
the test strip gently to the blood drop.

NOTE: If you are not using a pump, then you may choose to set
“Snd” to O” to save battery power.

Testing a Blood Sample

23

Testing a Blood Sample

Getting and Applying a Blood Sample from Forearm or Palm

1a. Select the Forearm test site in the high

-

lighted areas as shown.

NOTE: Thick hair at the sample site may
cause the blood drop to smear.

1b. Select the Palm Heel or Palm Side test

site in the highlighted areas as shown.

2. Attach the clear cap to the lanc­ing device. Press and hold the
lancing device FIRMLY against
the Forearm (or Palm).

3. Continue to hold FIRMLY and
press the release button to lance
the area.

Palm

Heel

OR

Palm

Side

Palm

Heel

24

Testing a Blood Sample

4. Continue to hold the device,
pressing FIRMLY until a proper
blood drop forms. The clear cap
allows you to see the blood drop.

5. Apply blood drop to the edge of
the test strip. The blood is drawn into the test strip. Hold the
monitor to the blood drop until you hear a short beep or see
the monitor begin to count down.

NOTE: The blood in the strip should look similar to the red blood
you are accustomed to seeing when you test your nger. If the
sample looks clear, pink, or light in color, retest with a ngertip
sample.

6. The blood glucose test result is displayed and stored. The test
is complete.

NOTE: If you get an error message when testing on your forearm or
palm or do not get a blood glucose reading after multiple attempts,
test on your nger and call Customer Service toll-free, 24 hours a
day, 7 days a week, in the US at 1-800-681-7390. THIS NUMBER IS

NOT FOR EMERGENCY OR MEDICAL INFORMATION.

25

Testing a Blood Sample

Limitations and Considerations: Forearm and Palm Testing

Some patients test their blood glucose at sites other than the
nger because it is generally less painful.

NOTE: Results from the forearm may be dierent from ngertip
results when glucose levels are changing rapidly, e.g., after a meal,
after taking insulin, or during or after exercise. Only use nger or
palm testing during these times.

The Nova Max Link reduces the pain of blood glucose monitoring
signicantly by requiring only 0.3 µL of blood sample.

CAUTION: Always seek the advice of your doctor or healthcare
professional before choosing to use forearm and palm sites.
Bruising may occur with forearm and palm testing.

26

Testing a Blood Sample

Do not use forearm testing:

• For at least 2 hours after you have eaten or injected insulin

• If you have recently exercised

• If you think that your blood glucose is low

• If you think that your blood glucose may be changing rapidly
(e.g., after a meal, after taking insulin, or during or after exercise)

• If you are not aware of symptoms when your blood glucose is
low (hypoglycemic)

• If your forearm test results do not match the way you feel,
retest using your nger or palm.

Consider NOT using forearm testing if you:

• Are ill

• Are under extra stress

• Routinely have widely uctuating blood glucose values that
are often low (hypoglycemic)

Values from the palm sample were shown to be equivalent to
values from the nger samples.

27

Your Test Result

Your blood glucose test result is displayed on
the monitor.

If test result is higher than 600 mg/dL, the
monitor displays “HI.” You may have high
blood sugar. Retest your blood glucose
immediately using a new test strip. If your
reading is still high, you should treat as
prescribed by your healthcare professional
and/or contact your healthcare professional
immediately.

If test result is lower than 20 mg/dL, the mon­itor displays “LO.” You may have low blood
sugar. Retest your blood glucose immediate­ly using a new test strip. If your reading is still
low, you should treat as prescribed by your
healthcare professional and/or contact your
healthcare professional immediately.
If you receive an Error Message, see page 31,
Displays, Meanings, Actions of this Owner’s
Guide.

28

Your Test Result

NOTE: Test results greater than 240 mg/dL may mean high blood

sugar (hyperglycemia). Test results lower than 60 mg/dL may mean
low blood sugar (hypoglycemia). If you get results in these ranges,
retest your blood glucose. If your reading is still in these ranges, you
should treat as prescribed by your healthcare professional and/or
contact your healthcare professional immediately.

NOTE: Hi and Lo values will not transmit to the insulin pump even
if “Snd” is “On” in setup.

Sending a Blood Glucose Result to Your Paradigm Model 512,
712, or Higher Insulin Pump

Your Nova Max Link Blood Glucose Monitor arrives with “Snd”
turned “On.” Thus, when a new blood glucose result is displayed,
the monitor will send the result to your pump. The new result
will ash on the monitor display while the monitor is sending the
result to your Paradigm Model 512, 712, or higher insulin pump.
The monitor will stop ashing when the pump receives the re­sult, or after 60 seconds.
A pump is only capable of receiving a blood glucose result if you
have entered the monitor’s ID number into the pump. No one
else’s pump can receive your blood glucose result, unless they
enter your monitor’s ID number into their pump. Please refer to
your Insulin Pump User Guide or the Getting Started Poster to
learn how to enter the monitor’s ID number into your pump.

29

NOTE: If the monitor displays “HI” or “LO,” no blood glucose result is
sent to the pump.

The monitor uses radio frequency (RF) signals to send the blood
glucose result to the pump. If you set “Snd” to “OFF,” your monitor
will not send a RF signal to your pump. You may want to turn
o the “Snd” feature to save battery power, if you do not have a
pump.

NOTE: To set up the “Snd” function, refer to Page 13.

Sending a Blood Glucose Result

30

Marking a Single Blood Glucose Test So It Is Not Sent to Your
Paradigm Model 512, 712, or Higher Insulin Pump

If you want to take a single blood glucose measurement and not
have that result sent to your Paradigm Model 512, 712, or higher
insulin pump, you can mark it as a control solution test.

1. Insert a Test Strip into the monitor.

2. A blinking blood drop tells you the monitor is ready for the
next step.

3. Press one of the arrow buttons before applying blood to the
test strip.

4. “Ctl” will appear on the display indicating that the result is a
control solution test. After you apply blood or control solu­tion to the test strip, the result will not be sent to your pump.
You may want to mark a result as a control test if:

• You are using control solution on a test strip to test your

monitor.

• You lend your monitor to someone else and you do not

want their result to appear on your pump.

• You do not want to generate an RF signal, such as if you

have been asked to turn o electronic devices on an air­craft.

Marking a Single Blood Glucose Test

31

Review Test Results in Memory

NOTE: If a test strip is inserted while in the Data Review mode, the
monitor immediately switches to test mode.

To review test results that are stored in memory, start with the monitor
in the o position. The monitor is in the o position when the screen is
completely blank. To turn o the monitor, hold the Mode button
down until the screen goes blank then release the button.

1. With the monitor o, press the Mode
button. The most recent test result should
display. If there are NO results in memory,
the screen displays 3 dashes.

2. Press the Left/Right button to
view all the data in memory. The Left arrow
goes back in time and the Right arrow goes
forward in time. All results including control
results, marked results, and unmarked results
can be viewed.

3. At the end of reviewing individual test re­sults, the screen displays “End Mem.”

NOTE: For data averaging, HI results equal
600 mg/dL and LO results equal 20 mg/dL.

32

4. To review 1 day, 7 day, 14 day, and 30 day average results,
press the Mode button.

5. If there are less than 2 test results in memory, the screen dis­plays 000. If no results, the screen displays 3 dashes.

6. After reviewing the 30 day average, press the Mode
button to shut o the monitor, or press no buttons and the
monitor will turn o automatically after 30 seconds.

NOTE: When the monitor memory is full (400 test results), each new
test result stored in memory will remove the oldest test result stored
in memory.

Review Test Results in Memory

33

Basic Upkeep

Battery Check

The monitor is powered by a single coin cell battery, CR2450
(3V). At the rst displaying of the battery icon in the upper right
corner of the screen and the blood drop at the lower left corner
of the screen, the monitor has sucient charge for 20 more tests.
Continue with testing as usual; the battery indicator will remain
on-screen.

After 20 tests have been performed, there will be insucient bat­tery charge to continue testing, and the monitor will no longer
operate until the battery is replaced. The battery icon will only
appear when a strip is inserted and the icon will disappear when
the strip is removed.

Battery low

34

Battery Replacement

Replace the battery as follows:

1. Remove the back battery
cover on the monitor.

2. Remove the battery and re­place with a new one with the
+ side facing up.

3. Replace the cover.

NOTE: After the battery is replaced, the monitor displays the all
segments screen. Then, the monitor displays the time set up. Reset
to the current time and date. If needed, go to page 11 in this guide
to review setting the time, date, and beeper. Discard batteries
according to your local environmental regulations.

Basic Upkeep

35

Cleaning and Care

The exterior of the Nova Max Link Blood Glucose Monitor should
only be cleaned with alcohol wipes/swabs. Keep liquids from
entering the test strip port or the Left, Right, and Mode buttons.

CAUTION: DO NOT attempt to open the monitor to make any re­pairs. Your warranty and all claims will be void! Only an authorized
service personnel can repair the monitor. Call Customer Service at
1-800-681-7390 if the monitor needs to be repaired or replaced.

Basic Upkeep

36

Displays, Meanings, Actions

This section addresses the messages that appear on your dis­plays, what they mean, and what action you need to take.

Displays, Meanings, Actions

Display What it Means What to Do

System Check. Veries
that all segments are
working.
Appears when:

• Monitor is turned on
for Setup and Memory
Review.

• Test strip is inserted
into the monitor.

No action required. If
all segments are not
displayed on monitor,
call Customer Service at
1-800-681-7390.

Blood Drop Symbol:
Monitor is ready to
accept blood.

Apply a blood sample
to the test strip. Refer to
page 19, Running a Test.

Countdown screen:
5-second countdown
as monitor calculates
the blood glucose test
result.

No action required.

37

Displays, Meanings, Actions

Display What it Means What to Do

A blood glucose test
result in mg/dL.

No action required.
Result is automatically
stored into memory.

If “Snd” is “On,” the result
123 will be ashing
during RF transmission
to the Paradigm Model
512, 712, or higher
insulin pump. It will
stop ashing once the
monitor receives an
acknowledgement from
the insulin pump or after
1 minute.

Record the result in your
logbook.

A blood glucose test
result in mg/dL stored in
the monitor’s memory
with date/time.

No action required.

38

Displays, Meanings, Actions

Display What it Means What to Do

Your blood glucose
reading is higher than
600 mg/dL. You may
have high blood sugar.

Retest your blood
glucose immediately.
If your reading is still
HI, you should treat
as prescribed by your
healthcare professional
and/or contact your
healthcare professional
immediately.

Your blood glucose
reading is lower than 20
mg/dL. You may have
low blood sugar.

Retest your blood glu­cose immediately. If your
reading is still LO, treat
as prescribed by your
healthcare professional
and/or contact your
healthcare professional
immediately.

End of Setup or Memory
Review.

No action required.

39

Displays, Meanings, Actions

Display What it Means What to Do

The average of all blood
glucose test results tak­en in the last 24 hours.

No action required.

No test results in the last
24 hours.

No action required.

The average of all blood
glucose test results
taken in the last 7 days.

No action required.

No test results in the last
7 days.

No action required.

The average of all blood
glucose test results
taken in the last 14 days.

No action required.

No test results in the last
14 days.

No action required.

40

Display What it Means What to Do

The average of all blood
glucose test results
taken in the last 30 days.

No action required.

No test results in the last
30 days.

No action required.

There are NO results in
memory.

No action required.

Battery is getting low,
but you can still perform
a test. Battery will
appear on all screens.

We suggest that you
replace the battery
immediately. There is
only enough power to
perform 20 tests.

A control solution test
result.

No action required.

A marked sample test
result.

No action required.

Displays, Meanings, Actions

41

Displays, Meanings, Actions

Display What it Means What to Do

Software Error Call Customer Service at

1-800-681-7390, 24 hours
a day, 7 days a week.

System Hardware Error Call Customer Service at

1-800-681-7390, 24 hours
a day, 7 days a week.

Operating Temperature
Error

Monitor is outside the
required testing tem­perature range of 57°
to 104°F (14° to 40°C).
Move the monitor to a
warmer or cooler area
and wait a few minutes.

Used Strip Error: Used or
damaged strip.

Retest with a new strip.

Blood Sample Error Incorrect application of

blood sample or con­trol solution onto the
test strip, or the test
strip may be damaged.
Review your sampling
technique.

42

Display What it Means What to Do

Monitor
does not
turn on after
inserting a
test strip.

• Test strip is inserted
upside down or not
completely in.

• Battery is dead.

• Battery is installed in

­correctly or there is no
battery in the monitor.

Insert the test strip
correctly with the Nova
name and white tip fac­ing up and out.

Replace the battery.
Check that the battery is

correctly installed with
the “+” sign facing you.

Call Customer Service
1-800-681-7390, 24
hours a day, 7 days a
week.

Monitor
does not
begin test
countdown
after apply­ing a blood
sample.

• Not enough blood
sample.

• Sample applied after
monitor automatically
turned o.

• Test strip may be
damaged.

• Monitor may not be
working properly.

Repeat the test with a
new test strip.

Repeat the test with a
new test strip.

Repeat the test with a
new test strip.

After 3 attempts, call
Customer Service at
1-800-681-7390,
24 hours a day, 7 days a
week.

Displays, Meanings, Actions

43

Appendix

Specications

Test Measured Blood Glucose
Glucose Methodology Glucose oxidase biosensor
Glucose Test Results mg/dL (Plasma values)
Sample type Capillary whole blood
Glucose Test range 20 to 600 mg/dL
Acceptable Hematocrit range 25% to 60%
Length of Test 5 seconds
Test Strip Volumes 0.3 µL
Battery Life (nominal) 500 Tests (Send on)
Low Battery Life About 10 Tests
Radio Frequency (RF) 916.5 MHz
Data Output Port Serial, USB
Operating Ranges
Temperature 57° to 104°F (14° to 40°C)
Humidity 10% to 90% relative humidity
Weight 2.65 oz (75 g)
Size 3.6x2.3x0.9 in

(91.4x58.4x22.9 mm)

Monitor data storage 400 Results

Chemistry Measurement

Glucose test imprecision

6% or 5.4 mg/dL (whichever is greater)

44

Limitations

The Nova Max Test Strips give accurate results when the follow­ing limitations are observed:

• The test strips should not be used to diagnose diabetes or to
test newborns.

• Each test strip is for single use only. Do not reuse. Use a new
sterile Nova Max Test Strip each time you test.

• Your test strips are for personal use only. DO NOT share with
others.

• Use only fresh capillary whole blood.

Do not use serum or

plasma.

• There is no eect on blood glucose values for altitudes up to
10,000 feet (3000 meters) above sea level.

• Refer to the Owner’s Guide for operating temperature range
for the monitor.

• Extremes in humidity (higher than 90% and lower than 10%)
may aect results.

• The Nova Max Test Strips are calibrated against plasma.

• The anticoagulant sodium heparin may be used. EDTA is not
recommended for use with Nova Max Test Strips.

• Interferences for elevated levels of acetaminophen, tolaza

­mide, uric acid, bilirubin, ephedrine, and methyldopa may
aect results.

Appendix

45

• Test results may be falsely low if the patient is severely dehy­drated.

• Critically ill patients should not be tested with home blood
glucose monitors.

Appendix

46

Appendix

Instructional Notes

1. If in setup mode when the test strip is inserted, the monitor
saves all values entered up to that point and immediately
switches to test mode. Upon exiting test mode the monitor
screen goes blank and does not return to setup mode.

2. If in Data Review mode when the test strip is inserted, the
monitor immediately switches to test mode. Upon exiting
test mode the monitor screen goes blank and does not return
to Data review mode.

3. Battery low icon is displayed in every mode except setup.

4. Once battery level goes below the threshold that triggers the
“low battery” warning, it continues to give the warning until
the monitor becomes unusable due to low battery.

5. The Monitor responds to the pressing and the holding of keys:
Left/Right buttons

- The Left/Right button moves forward/backward through a

series of stored test result screens or increments of value.

- Hold down the Left/Right button to speed up screen

change process.

MODE button

- When the MODE button is pressed less than 1.5 seconds

to advance to the next function, the monitor advances to
next screen immediately when button is pressed.

47

Appendix

- While monitor is in sleep mode (OFF), pressing the MODE
button less than 1.5 seconds wakes up the monitor and
enters data review mode.

- While monitor is in sleep mode (OFF), pressing the MODE
button greater than 3.0 seconds wakes up the monitor
and enters setup mode.

- While monitor is awake (ON), pressing the MODE button
greater than 1.5 seconds manually turns o the monitor
(sleep mode).

6. With no activity, time-out occurs after the following times:

- 1 minute for all screens

- 2 minutes during test mode

- 3 minutes when download connector inserted

48

Warranty

Your Nova Max Link Blood Glucose Monitor is warranted to be free of
material and workmanship defects for 3 years from the date of pur­chase (except as noted below). If at any time during the rst 3 years af­ter purchase, your Nova Max Link Monitor does not work for any reason
(other than as described below), it will be replaced with a new monitor,
or a substantial equivalent, free of charge.
Limitations on Warranty: This warranty is subject to the following
exceptions and limitations:

1. This warranty is applicable only to the original purchaser.

2. This warranty does not apply to units which malfunction or are
damaged due to obvious abuse, misuse, alteration, neglect, unau­thorized maintenance or failure to operate meter in accordance
with instructions.

3. We have no knowledge of the performance of the Nova Max Link Moni­tor when used with test strips other than Nova Max Test Strips. Therefore,
we make no warranty as to the performance of the Nova Max Link Moni­tor when used with any test strips other than Nova Max Test Strips.

4. There is no other express warranty for this product. The option of
replacement, described above, is the warrantor’s only obligation
under this warranty.

For warranty service: The original purchaser must contact Nova Cus­tomer Service by calling toll-free at 1-800-681-7390.
Privacy Policy: Both Nova, as manufacturer, and Sanvita, as the Nova
Max Link exclusive distributor, are committed to using your personal
information responsibly and in compliance with the law. You have our
pledge that we will not share or sell your personal information with
marketers or third-parties. The information you voluntarily share with
us will be used to help us serve you better in the future.