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Owner's Manual

PRODIGY*

Blood Glucose Monitoring System

FTP R O D I G Y

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Prodigy AutoCode Talking Meter     Owner's Manual

Dear Prodigy Owner:

Thank you for choosing the Prodigy Autocode® Talking blood glucose
monitoring system. Please read this manual carefully as it contains important
information about your new Prodigy® system. A warranty registration card is
included with your system. Please return the completed card to us.

Prodigy® meters are designed to help you and your healthcare professionals
monitor your blood glucose levels. This owner's manual will help you learn how
to use the Prodigy Autocode® Talking Meter effectively. Technical support is
available 24 hours/7 days a week by calling 1-800-243-2636. All questions about
interpreting the results should be directed to your healthcare professionals.

The Prodigy Autocode® is the latest technology for blood glucose
monitoring. It is easy to use and will give you fast and accurate results with
a minimal sample of blood. It has a large screen display for easy reading and
is small and lightweight for portable convenience.

The Prodigy Autocode® Meter: Requires no-coding, allowing you to save time
and avoid human error due to improper coding. Allows You to Perform
Alternative Site Testing (AST). Has memory and data management capabilities.
Prodigy®'s free software, available at www.prodigymeter.com, gives you and your
healthcare professionals powerful graphic tools to manage your diabetes.

Diagnostic Devices, Inc.     1.800.243.2636

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Important Safety Instructions     4
Important Health-Related Information     5
About Alternative Site Testing (AST)     6
Introduction to the Prodigy Autocode® Meter     8
Intended Use     8
Test Principle     8
Contents of the Prodigy Autocode® Meter     9
Key Functions of the Meter     10
Setting up the Prodigy Autocode® Meter     11
Meter Display      11
Speaking Function     12
Key Functions of the Test Strips     13
Important Test Strip Information     14
Set-Up Steps     15
Control Solution Testing     19
About Prodigy® Control Solution     19
Important Control Solution Test Information     20
Performing a Control Solution Test     21

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Blood Glucose Testing

Preparing the Lancing Device

Getting a Blood Sample

Performing a Blood Glucose Test

Using the Meter Memory

Viewing Results on a Personal Computer

Caring for your Prodigy Autocode® Meter

Maintenance

Battery

Battery Replacement

System Troubleshooting

Special Messages

Error Messages

Troubleshooting Guide

Information about your Prodigy Autocode® Meter

Comparing Meter and Laboratory Results

Specifications

Performance Characteristics

Expected Test Results

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Prodigy AutoCode" Talking Meter     Owner')

Important Safety Instructions

Read this before using your Prodigy Autocode® Meter. The following basic
safety precautions should always be taken.

Close supervision is necessary when the device is used by, on, or near
children, handicapped persons or invalids.

Use the device only for the intended use described in this manual.

Do not use test strips and control solutions that are not supplied by the
manufacturer.

Do not use the device if it is not working properly, or if it has suffered any
damage.

Before using any product to test your blood glucose, read all instructions
thoroughly and practice the test.

Do all quality control checks as directed and consult with a diabetes
healthcare professional.

Warning: Keep the test strip vial away from children; the vial cap and the
test strips can be a potential choking hazard. Never chew or swallow a test
strip. If this occurs, please seek medical assistance immediately.

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Important Health-Related Information

Severe dehydration and excessive water loss may cause false low results.
If you believe you are suffering from severe dehydration; consult a healthcare
professional immediately.

Elevated blood triglycerides, reducing substances such as uric acid and
ascorbic acid at normal blood concentration, or acetaminophen, dopa,
methyldopa, L-dopa, and tolbutamide at normal blood concentrations should not
significantly affect the results.

Test results below 60 mg/dL (3.3 mmol/L) indicate low blood glucose
(hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L) indicate high
blood glucose (hyperglycemia). If your results are below 60 mg/dL or above 240
mg/dL, repeat the test, and if the test results are still below 60 mg/dL (3.3
mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare professional
immediately.

Inaccurate results may occur in severely hypotensive individuals or
patients in shock. Inaccurate low results may occur for individuals
experiencing a hyperglycemic-hyperosmolar state, with or without ketosis.
Critically ill patients should not be tested with blood glucose meters.

Please refer to your test strip package insert for additional important
information.


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About Alternative Site Testing (AST)

There are important limitations to AST. Please consult healthcare
professional before you perform AST.

What is AST?

Alternative Site Testing (AST) means you can use parts of the body other
than your fingertips to check your blood glucose levels. The Prodigy Autocode®
Meter allows you to test on your palm, forearm, upper arm, calf or thigh. See
Figure 1.

What is the advantage?

Fingertips feel pain more readily     because they are full of nerve     endings
(receptors). At other body sites, nerve endings are not so     numerous and
you will not feel as much pain as you will experience at the fingertip.

When to use AST?

Food, medication, illness, stress, and exercise can affect blood glucose
levels. Capillary blood at the fingertip reflects these changes faster than
capillary blood at other sites. Therefore, if you are testing your blood
glucose level during or immediately after a meal, physical exercise or
stressful event, take the blood sample from your fingertip only.

Figure 1 (not shown)

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Use AST only:

?     Two hours or more after your last meal.

?     Two hours or more after taking insulin.

?     Two hours or more after exercise.

?     During steady state blood glucose conditions.

Do not use AST if:

?     You have reason to believe you have hypoglycemia or hyperglycemia.

?     Your routine glucose results are often fluctuating.

?     You are pregnant.

*To increase the accuracy when using AST, rub the puncture site before
extracting blood.


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Introduction to the Prodigy AutoCode® Meter

Intended Use

The system is intended for use outside the body (in vitro diagnostic use
only). It should be used only for testing blood glucose (blood sugar) and only
with fresh capillary whole blood samples. The system is intended for use in the
home and in clinical settings. It should not be used for the diagnosis of
diabetes or for the testing of newborns.

Test Principle

Blood glucose is measured by an electric current that is produced when a
blood sample mixes with the reagent (special chemicals) of the test strip. The
electrical current changes with the amount of glucose in the blood sample. The
Prodigy AutoCode® Meter measures the strength of the electrical current,
calculates your blood glucose level and then displays your result in either
"mg/dL" or "mmol/L."

The Prodigy AutoCode® Meter, Test Strips and Control Solutions have been
designed, tested and proven to work together as a system to produce accurate
blood glucose test results.

Important: Use only Prodigy® Control Solutions and Test Strips with your
Prodigy Autocode® Meter. Using other test strips and control solutions with
this meter can produce inaccurate results.

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Contents of the Prodigy AutoCode® Meter

The Prodigy AutoCode® Meter is available as a meter only or as a meter
kit. Please check the "REF" number marked on the outside of the box to see if
you have purchased a "Meter" or a "Meter Kit." Please review the contents of
your purchase to confirm that all the components are included as listed below:

REF #51850 or REF #51885

Your "Meter" Includes:
Prodigy AutoCode® Talking Meter
Two (2) AAA Batteries
Carrying Case
Complete Instructions:
-     Manual
-     Log Book
-     Quick Reference
-     Warranty Card

*You can purchase additional supplies from your provider

REF #51880 or REF #51890

Your "Meter Kit" includes:
Prodigy Autocode® Talking Meter
Two (2) AAA Batteries
Prodigy® Control Solution (4ml)
Prodigy® Test Strips (lOct
Sterile Lancets (lOct)
Lancing Device
Complete Instructions:
-     Manual
-     Log Book
-     Quick Reference
-     Warranty Card


Important: Please review the contents of your purchase. If any items are
missing, please return your meter to the place of purchase.


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Key Functions of the Meter

Figure 2 Front (not shown)


Test Slot
Insert the test strip here.

The meter will turn on automatically.

LCD Display
Guides you through the test using symbols and simple messages.

Talking Symbol
Confirms audio function.

Main Button --
Turns the meter on or performs other functions described in this manual.

Set Button Located in the battery compartment; used to set up the meter.

Data Port
Port for USB Cable connection to your computer.

Figure 4 - Back (not shown)


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Setting Up the Prodigy AutoCode® Meter


Meter Display

Day Average

Indicates that the displayed test result is an average. Date

Time

OOrDD^dOiflD

DON

bE

Figure 5 (not shown)

Indicates what unit of measure the test result is displayed in.

Test     1--|

Result Area l^pP

Displays test j^TJ results.     I I

Test Strip I     I

Symbol     ^"W

Appears     _J--

when the HJ_E

meter is '

turned on.

Blood Drop Symbol Flashes

when sample should be applied.

Unit of Measure

Memory Symbol

Appears when you review the memory.

Temperature Symbol

Appears when ambient temperature is outside of operating range.

Low Battery Symbol

Appears when the battery power is low.

Voice Symbol

Shows if audio function is on.

Control Solution Test Symbol

Shows that you are in Control Solution Mode.


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Speaking Function

The Prodigy AutoCode® Meter talks you through each step in your testing
procedure.

When does the meter speak?

When the meter is turned on.

What does the meter say?

Your Prodigy® Meter is

 

 

When room temperature is outside operating range; which is 50F ~ 104F

Room temperature is out range.

 

 

When the meter is ready to test.

(v appears on display)

Please apply blood to the strip.

 

 

When the test is completed. (The result appears on display)

Your blood glucose is (number) milligrams per deciliter/millimoles per liter.

 

 

When there is not enough blood in the test strip.

Your blood sample is not enough.


When you turn off the meter. Goodbye.


When a used test strip is inserted.

Test strip has been used.


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Key Functions of the Test Strip

The Prodigy Autocode® Meter measures the amount of blood glucose (blood
sugar) in whole blood. Blood is applied to the opening of the absorbent channel
of the test strip and is automatically drawn.

The test strip consists of the following parts:

Absorbent Channel

Apply a drop of blood and it will be drawn in automatically.

Confirmation Window

Shows whether enough blood has been drawn into the test strip's absorbent
channel.

Test Strip Handle

Hold this part to insert the test strip into the test strip port on the
meter.

Contact Bars

Insert this end of the test strip into the meter. Push it in firmly until
it will not go any further.

Please refer to the "Performing a Blood Glucose Test" Section for complete
instructions.


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Important Test Strip Information

Store test strip packages in a cool, dry place between 39.2F ~ 104F (4C
~ 40C). Keep away from direct sunlight and heat. Do not refrigerate. Store
your test strips in their original vial only. Do not transfer them to a new
vial or any other container. With clean, dry hands, you may touch the test
strip anywhere on its surface when removing it from the vial or inserting it
into the meter. After removing a test strip from the vial, use it immediately
then replace the vial cap and close it tightly. Use each test strip
immediately after removing it from the vial. Only apply a blood sample or a
control solution sample to the test strip's absorbent channel. Applying other
substances to the test strip's absorbent channel will cause inaccurate
results.

Record the discard date on the vial label when you first open it. Discard
remaining test strips 90 days after the first opening date. Do not use test
strips beyond the expiration date printed on the package. Do not bend, cut or
alter a test strip in any way.

Warning: Keep the test strip vial away from children; the vial cap and the
test strips can be a potential chocking hazard. Never chew or swallow a test
strip. If this occurs, please seek medical assistance immediately.

Diagnostic Devices, Inc.     www.prodigymeter.com

14
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Set-Up Steps

The Prodigy AutoCode® Meter has the language, volume, time, date and unit
of measure presets. However, if you change the time or replace the batteries,
you should check and update the time and date.

STEP 1: Enter Set-Up Mode

Start with the meter off. Then press the "SET" button located in the
battery compartment. The meter is now in the set-up mode.

STEP 2: Select Language

The language option appears first; press the "SET" button; then "L-1" or
"L-2" will appear on the LCD. By default, "L1" indicates default language and
"L2" indicates second language.

Press the "M" button to select language. With the correct language on the
display, press the "SET" button and a number will appear. See Figure 6.

Figure 6 (not shown)


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STEP 3: Setting Volume Level

The meter displays "VOL" and a flashing number. Press the "M" button to
select the speaking volume. Then press the "SET" button and the year segment
will appear and start flashing. Number 0 indicates that the speaking function
is turned off. Numbers 1 to 3 indicate speaking volume from low to high, where
"i]l" is displayed on the LCD during testing.

See Figures 7 and 8.

STEP 4: Set the Year

Press and release the "M" button to advance the year. With the correct
year on the display, press the "SET" button and the date will appear on the
display with the month segment flashing. See Figure 9.

STEP 5: Set the Month

Press and release the "M" button to advance the month. With the correct
month on the display, press the "SET" button and the day segment will start
flashing. See Figure 10.

Figure 8 (not shown)


Figure 10 (not shown)


Diagnostic Devices, Inc.

www.prodigymeter.com
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STEP 6: Set the Day

Press and release the "M" button to advance the day. With the correct day
on the display, press the "SET" button and the time will appear on the display
with the hour segment flashing. See Figure 11.

STEP 7: Set the Hour

Press and release the "M" button to advance the hour. With the correct
hour on the display, press the "SET" button and the minutes segment will start
flashing. See Figure 12.

STEP 8: Set the Minutes

Press and release the "M" button to advance the minutes. With the correct
minutes on the display, press the "SET" button and the current unit of
measurement will start flashing. See Figure 13.

Figure 12 (not shown)

Figure 13 (not shown)


Important: Day averages are calculated from results obtained during the
7,14 and 28 days preceding the current date and time settings.


.
STEP 9: Select Unit of Measure

Press and release the "M" button until the unit of measurement you are
choosing appears on the display. Press the "SET" button and the memory segment
will start flashing. See Figures 14 and 15.

Your meter can display test results in milligrams per deciliter (mg/dL) or
millimoles per liter (mmoL/L.) The mg/dL unit is standard in the United States.
The mmol/L unit is standard in Canada.

STEP 10: Delete Memory When the "dEL" symbol and the flashing "M" symbol
appear on the display, you can choose to clear the memory. If you do not want
to clear the memory, press the "SET" button again to skip this step. If you
want to clear ALL memory, press the "M" button for (4) four seconds and both
"dEL" and "M" will flash. Press the "M" button again to delete ALL memory. The
"- - -" will appear to indicate all memory has been deleted. See Figure 16.

Set-up is now completed. Press the "SET" button to turn off the meter.
"OFF" is displayed before shut down. See Figure 17

Figure 14 (not shown)

Figure 15 (not shown)

Figure 17 (not shown)


Diagnostic Devices, Inc.
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Control Solution Testing

About Prodigy® Control Solution

Prodigy® Control Solution is a red liquid that contains glucose that will
react with test strips and produce a test result. Prodigy® systems use a high
or low control solution.

?     First, check your contents to see if you have a high or low control
solution in your meter kit.

?     Then, after completing a control solution test, compare results with
the correct range (high or low) located on the back of the test strip vial.

Why perform a control solution test?
To ensure that your meter and test strips are working properly together.

To practice testing without using your own blood.

It is recommended to do a control solution test:
Once a week (to make sure that you continue to get accurate results).
When you begin using a new vial of test strips.
When test strips are exposed to extreme environmental conditions.
If you drop the meter.
If you change the batteries.

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Important Control Solution Test Information

Use only Prodigy® Control Solutions.

Check the expiration date on the control solution bottle. Do not use if expired.

Control Solution, meter and test strips should come to room temperature (68 -
77F / 20 - 25C) before testing.

Use within a period of 90 days from the date that you first open it. Record the
discard date on the control solution bottle and discard after 90 days.

Store the control solution tightly closed at temperatures below 86F (30C). Do
not refrigerate.

Important: Prodigy®'s Control Solution ranges are located on the back of
the test strip vial. They are not recommended target ranges for your blood
glucose level.

Diagnostic Devices, Inc.     www.prodigymeter.com

20
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Performing a Control Solution Test

Start with the meter off.

STEP 1: Insert Test Strip

Insert a test strip with the contact bar end entering into the test slot
first. Push the test strip as far as it will go without bending it. The meter
turns on automatically. See Figure 18.

STEP 2: Mark as a Control Solution Test

After the " " symbol appears on display, press the "M" button and a
control solution bottle symbol appears on display. With the control solution
bottle symbol on the the display, the meter will not store your test result in
the memory. If you decide not to perform a control solution test, press the "M"
button again and the control solution bottle symbol will disappear. See Figure
19.

Important: Be sure that you are in Control Solution Mode so that the test
result will not be stored in the meter memory.

Figure 18 (not shown)

Figure 19 (not shown)


.
STEP 3: Apply Control Solution

Shake the control solution bottle well. Remove cap. Squeeze the bottle,
discard the first drop, and wipe off the dispenser tip with a clean tissue
paper or cotton. Squeeze the bottle again to get a second drop onto a clean
non-absorbent surface or on your fingertip first. Then apply the drop to the
opening of the absorbent channel of the test strip (where it meets the narrow
channel) until the confirmation window is filled. The meter begins to count
down. See Figures 20, 21 and

Figure 20 (not shown)


Caution: To avoid contaminating the control solution with the content of
the test strip, DO NOT DIRECTLY APPLY CONTROL SOLUTION ONTO THE TEST STRIP.


Figure 21 (not shown)

Figure 22 (not shown)


Diagnostic Devices, Inc.

www.prodigymeter.com

22
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STEP 4: Check if the Test Result is in Range.

In less than (7) seconds, the control solution test result appears on the
display. Compare the test result with the range printed on the test strip vial.
The test result should fall within the printed range See Figure 23.

You will hear a voice message, "Blood glucose Is     (number) (unit)".

Out of Range Results

If test results fall outside the range printed on the test strip vial,
check "Trouble-Shooting Guide" located in the "System Troubleshooting' Section
and repeat the test.

Figure 23 (not shown)


If you continue to get out-of-range results, it means that the system or
the control solution may not be working properly. DO NOT use the system to test
your blood glucose level. If you are unable to resolve the problem, contact
Technical Support at 1-800-243-2636.


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Blood Glucose Testing

Preparing the Lancing Device

STEP 1: Remove the cap by twisting it

STEP 2: Insert a Sterile Lancet into the Lancing Device. Insert the lancet
into the lancet holder and push down firmly until it is fully seated. Do not
twist the lancet. See Figure 24.

Figure 24 (not shown)

STEP 3: Remove the protective cap from the lancet by twisting it and then
save it for later use. See Figure 25.

STEP 4: Replace the cap onto the Lancing Device. Screw the cap until it is
snug but not too tight.

Figure 25 (not shown)


Diagnostic Devices, Inc.

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STEP 5: Set the Lancing Level. The adjustable tip offers 5 levels of skin
penetration. To select the desired depth, twist the adjustable tip in either
direction until the number lines up with the arrow. To select the best depth:
1-2 for soft or thin skin, 3 for average skin, 4-5 for thick or callused skin.
See Figure 26.

Figure 26 (not shown)


Warning: To reduce the chance of infection:
Never share a lancet or the lancing device.
Always use a new, sterile lancet.
Lancets are for single use only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the
lancing device.

.
Alternative Site Testing (AST)

When you want to obtain blood from sites other than the fingertip, use the
clear cap. Screw the clear cap onto the Lancing Device until it is snug but not
too tight, and then go to Step 6.

STEP 6: Cock the Lancing Device.

Slide the ejection/cocking control back until it clicks. If it does not
click, the lancing device may have been cocked when the lancet was inserted.
See Figure 27.

*The Lancing Device is prepared and ready to lance your finger for a blood
sample.

Figure 27 (not shown)


Getting a Blood Sample

STEP 1: Wash Your Hands and the Puncture Site
Use warm, soapy water.
Rinse and dry thoroughly.

STEP 2: Lance the Selected Puncture Site

Fingertip     gure

Hold the lancing device firmly against the
side of your finger. Press the Release button.
You will hear a click, indicating that the
puncture is complete. See Figure 28.

Diagnostic Devices, Inc.

www.prodigymeter.com
.
Prodigy AutoCode" Talking Meter     Owner's Manual

Sites other Than Your Fingertip

Please refer to the "About Alternative Site Testing (AST)" Section. Please
consult your healthcare professional before obtaining blood from sites other
than your fingertip.

Caution: The Prodigy AutoCode® Meter only requires a tiny blood sample to
perform a test. Choose a different spot each time you test. Repeated punctures
in the same spot may cause soreness and calluses.

STEP 3: Gently Massage the Area

Do not smear the blood sample. To obtain the most accurate test results,
wipe off the first drop of blood and gently squeeze another drop of blood. See
Figures 29 and 30.

STEP 4: Remove the Lancet

Take the lancet out carefully. Place the Figures 29 and 30 protective cap
back on the exposed tip of the lancet.

*     Always use caution when removing the lancet. Discard the lancet
according to your local regulations.

Warning: The first drop of blood usually contains tissue fluid and serum,
which may affect the test result. It should be discarded.

Diagnostic Devices, Inc.     1.800.243.2636

27

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Performing a Blood Glucose Test

STEP 1: Insert the Test Strip

Insert a test strip with the contacts bar end entering into the test slot
first. Push the test strip as far as it will go without bending it. The meter
turns on automatically. See Figure 31.

STEP 2: Apply Blood Sample

You will hear a voice message, "Please apply blood onto the strip."

When the meter shows the " 4 " apply blood to the opening of the absorbent
channel of the test strip where it meets the narrow channel. Blood will be
drawn into the test strip. See Figure 32.

The test strip confirmation window should be completely filled before the
meter begins to count down. The meter will keep inidicating the confirmation
window is full. See Figure 33.

518in

in

Figure 31 (not shown)

 

Diagnostic Devices, Inc.

Figure 33 (not shown)
.
If not, do not try to add more blood to the test strip. Discard the test
strip and retest with a new one. If you have trouble filling the test strip,
please contact Technical Support for assistance.

Caution: DO NOT:
Smear or scrape the blood onto the test strip.
Apply blood to the test strip when the test strip is out of the meter
Put blood or foreign objects into the test strip slot.

STEP 3: Read Your Result

You will hear a voice message, "Blood glucose Is (number) (unit)."

After the meter counts down from 6 to 0, your blood glucose test result
appears along with the unit of measure, date and time. The speaker will
announce the test result. This blood glucose result is automatically stored in
the meter memory. Turn the meter off by removing the test strip. Discard the
used test strip carefully to avoid contamination. See Figure 34.

Figure 34 (not shown)

Important: If you do not apply a blood sample within (5) five minutes, the
meter will automatically turn off. You must remove the test strip and re-insert
it again to turn on the meter and restart the test procedure.


.
Using the Meter Memory

The Prodigy AutoCode® Meter stores a maximum of the 120 most recent blood
glucose test results with date and time in its memory. It also provides you
with 7, 14, 21 and 28 day averages of your blood glucose test results. You can
review the individual or average test results by entering the memory mode.


STEP 1: Enter the Memory Mode

While the meter is turned off, press the "M" button twice. The 7-day
average will appear, indicating that you are in the memory mode. If you
continue to press the "M" button, the 14 and 28-day averages will appear in
order. You can then review the last 120 individual test results in memory. When
using the meter for the first time,"- - -" appears, indicating no test results
are in the memory. See Figure 35.

STEP 2: Recalling Average Test Results

The 7-day average is calculated from the blood glucose results obtained
during the last 7 days. It also indicates how many blood glucose tests have
been performed within this period, e.g., 21 (21 tests in the last 7 days). See
Figure 36.

Figure 35 (not shown)


Figure 36 (not shown)

 

Diagnostic Devices, Inc.

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The 14-day average is calculated from the blood glucose test results
obtained during the last 14 days. See Figure 37.

It, too, indicates how many blood glucose tests have been performed, e.g.,
41 (41 tests in the last 14 days). The 28-day averages show the same
information.

STEP 3: Recalling Individual Test Results

After the 28-day average, the most recent test result with date and time
will be shown. Press the "M" button once and the next most recent test result
will appear. Each time you press and release the "M" button, the meter will
recall up to your last 120 test results in order. When the memory is full, the
oldest test result is dropped as the newest is added.After reaching the last
set of results, the meter will turned automatically. See Figure 38.

Figure 37 (not shown)

Figure 38 (not shown)

 

STEP 4: Exit the Memory Mode

Press and hold the "M" button for three (3) seconds to turn off the meter.

Important: If you do not press any button for three (3) minutes, the meter
will display "OFF" and turn off automatically.


.
Viewing Results on a Personal Computer

Test results in the memory can be transmitted to your personal computer.
Prodigy® Diabetes Management System Software and standard USB cable are needed
before installation. The free software can be downloaded from
www.prodigymeter.com. To learn more about Prodigy® Diabetes Management System
Software, please contact your local diabetes supplier.

STEP 1: Install Software

Install Prodigy Diabetes Management System Software on your computer by
following the instructions provided on our website:
Go to http://www.prodigymeter.com and
click on "Software Downloads".

STEP 2: Connect to a Personal Computer

Connect the USB Cable to your computer. Connect the USB Cable to the Data
Port of the meter. "Lnk" will appear if the USB cable is connected to the
meter.

"USb" will appear on the display indicating that the meter is successfully
communicating to your computer. You can begin to download the data from the
meter. See Figures 39 and 40.

Figure 39 (not shown)

Figure 40 (not shown)


Diagnostic Devices, Inc.

www.prodigymeter.com
.
STEP 3: Transmit Data

Follow the instructions provided in the software to transmit data. Test
results transmitted will include data and time. Remove the USB Cable and the
meter will automatically turn off.

Important: While the meter is connected to the PC, it is unable to perform
a blood glucose test.

Diagnostic Devices, Inc.     1.800.243.2636

33
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Caring for your Prodigy AutoCode® Meter

Maintenance

The Prodigy AutoCode® Meter does not require special maintenance. Avoid
getting dirt, dust, blood, control solution or water inside the meter through
the test port or data port. Store the meter, test strips and control solution
in the carrying case after each use in a cool, dry place. Do not refrigerate.
Use a cloth dampened with water and mild detergent to wipe the outside of the
meter.

*Your meter is a precision instrument. Please handle it with care.

Battery

Your meter comes with two (2) 1.5V AAA alkaline batteries. The meter will
alert you when the power is getting low by displaying two (2) different
messages:

When the " *=>" symbol appears alone on the display, the meter is
functional and the result remains accurate, but you should change the batteries
as soon as possible. See Figure 41. When the " i=3 " symbol appears together
with the "E-b" symbol on the display, the batteries do not have enough power
for a test. You must change the batteries before using the meter. See Figure
42.

Figure 41 (not shown)

Figure 42 (not shown)


Diagnostic Devices, Inc.

.
Battery Replacement

To replace the batteries, make sure the meter is turned off.

STEP 1: Press the buckle on the battery cover and lift up to remove the
cover. See Figure 43.

STEP 2: Remove old batteries and replace with two (2) 1.5V AAA alkaline
batteries. See Figure 44.

STEP 3: Close the battery cover. See Figure 45.

STEP 4: Check the time and date. Replacing the batteries does not affect
the previous test results stored in memory. However, the time, date and units
settings may need to be updated.

Caution: As with all small objects, the batteries should be kept away from
small children as they may be a potential choking hazard. If a battery is
swallowed, seek medical assistance immediately.

Figure 43 (not shown)

Figure 44 (not shown)

Figure 45 (not shown)


.
System Troubleshooting

Special messages and Error messages help to identify certain problems but
do not appear in all cases when a problem has occurred. Improper use may cause
an inaccurate result without producing an error message.

If the problem is not resolved, please call Technical Support at
1-800-243-2636 for assistance.

Special Messages Message     What It means

 

Blood Glucose level LOW

"Lo" appears when your result is below the measurement limit, which is
less than 20 mg/dL (1.1 mmol/L). "Lo" indicates hypoglycemia (low blood
glucose.) You should immediately consult your healthcare professional.


Blood Glucose level high

"high" appears when your result is above the measurement limit, which is
higher than 600 mg/ dL (33.3 mmol/L). You should immediately consult your
healthcare professional.


.
Error Messages

What it means

Appears when the batteries cannot provide enough power for a test.

Action

Replace the batteries immediately.


I

II

u

Appears when a used test strip is inserted.

Test with a new test strip. If the problem persist, please contact
Technical Support at 1.800.243.2636.


W3

Appears when the environmental temperature is below the system operation
range 50F ~ 104 f
Repeat the test after the meter and test strip is within the operation
temperature range.


13

System Error

Contact Technical Support at 1.800.243.2636.


.
Owner's Manual

Prodigy AutoCode'Talking Meter

Troubleshooting Guide ,. The meter does not display a message after '
inserting a test strip. Probable Cause What to Do Batteries exhausted. Replace
the batteries. Batteries incorrectly installed or absent. Check that the
batteries are correctly installed. Test strip inserted upside or incompletely.
Insert the test strip correctly with the contact bars end entering first and
facing up. Meter malfunction. Please contact Technical Support at
1-800-243-2636 for assistance.

* The test does not start after applying the
sample. Probable Cause What to Do Insufficient blood sample. Repeat the test
using a new test strip with a larger blood sample. Defective test strip. Repeat
the test with a new test strip. Sample applied after automatic shut-off (5
minutes after last user action). Repeat the test with a new test strip. Apply
sample only when the " 4 " symbol appears on the display. Meter malfunction.
Please contact Technical Support at 1-800-243-2636 for assistance.

.
? The test does not start after applying the sample.


Probable Cause

What to Do


Error in peforming the test.
Read the instructions thoroughly and repeat the test again.


Control Solution bottle not shaken well.
Shake the Control Solution bottle vigorously and repeat the test again.


Expired or contaminiated Control Solution.
Check the expiration date or the discard date of the Control Solution.


Control Solution that is too warm or too cold.
Control Solution, meter, and test strips should come to room temperature (68 -
77F/20 - 25C) before testing.


Test strip deterioration.
Please repeat the test with a new test strip.


Meter malfunction.
Please contact Technical Support at 1-800-243-2( for assistance.


.
Information about Your Prodigy AutoCode® Meter

Comparing Meter and Laboratory Results

The test result you obtain from your meter may differ somewhat from your
laboratory results due to normal variation. Meter results can be affected by
factors and conditions that do not affect laboratory results in the same way.
(See test strip package insert for typical accuracy and precision data and for
important information on limitations.) To make an accurate comparison between
meter and laboratory results, follow the guidelines below.

Before you go to the lab:
Perform a control solution test to make sure that the meter is working properly.
It is strongly recommended to fast for at least eight (8) hours before doing
comparison tests. Take your meter with you to the lab.

While at the lab:
Make sure that the samples for both tests (the meter test and the lab test) are
taken and tested within 15 minutes of each other. Wash your hands before
obtaining a blood sample. Never use your meter with blood that has been
collected in a gray top test tube. Use fresh capillary blood only.

Diagnostic Devices, Inc.

.
You may still have a variation from the result because blood glucose
levels can change significantly over short periods, especially if you have
recently eaten, exercised, taken medication or experienced stress . In
addition, if you have eaten recently, the blood glucose level from a finger
stick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein
(venous sample) used for a lab test . Therefore, it is best to fast for eight
(8) hours before doing comparison tests. Factors such as the amount of red
blood cells in the blood (a high or low hematocrit) or the loss of body fluid
(severe dehydration) may also cause a meter result to be different from a
laboratory result.

References.!) Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988),
April, 49-51. 2) Sacks, D.B:"Carbohydrates. "Burtis.C.A, and
Ashwood,E.R.(ed.),Tietz Textbook of Clinical Chemistry. PhiladelphiaMB.
Saunders Company (1994),959.

Diagnostic Devices, Inc.     1.800.243.2636
.
Specifications

Dimensions 3.78 in. (L) x 2.05 in. (W) x .91 in. (H)
52 mm (L) x 96 mm (W) x 22 mm (H)

Weight:
2.76 oz.
55 g

Power source: Two (2) 1.5V AAA alkaline batteries

Battery life: Over 1,000 tests

Display: LCD

Memory: 120 measurement results with date and time

External output: USB Data Port

Auto electrode inserting detection

Auto sample loading detection

Auto reaction time count-down

Auto turn-off after (5) five minutes without action

Temperature warning

Operating condition: 50F ~ 104F (10C ~ 40C), below 85% R.H.
(noncondensing)

Storage/Transportation condition: 39.2F ~ 104F (4C ~ 40C), below 85%
R.H.

Measurement Units: mg/dL or mmol/L

Measurement Range: 20 ~ 600 mg/dL (1.1 ~ 33.3 mmol/L)

*The specifications may be changed without prior notice.


Diagnostic Devices, Inc.
www.prodigymeter.com

.
Performance Characteristics

Accuracy: 15mg/dL when glucose <75mg/dL

20% when glucose >75mg/dL

Precision: This study shows the CV (correlation variation) is less than 5%.

The device has certified to meet the following standards:

98/79/EC, IEC 60601-1, IEC 61010-1, IEC 60601-1-2, IEC61326, and ISO 15197

.
Ml

Expected Test Result

 

Time of day Plasma glucose Your target range for people range without
diabetes (mg/dL)/(i (mg/dL)/(mmol/L)

Fasting and Less than (mg/ before meal 110/6.1 (mmol/L)

2 hours after Less than (mg/ meals 140/7.8 (mmol/L)

Bedtime Not specified (mg/

(mmol/L)

Between 2 AM Not specified (mg/ and 4 AM (mmol/L)

Source: ADA Clinical Practice Recommendations 2008

Please work with your doctor to determine a target range that works best
for you.

The Prodigy AutoCode® Meter is designed to help you and your healthcare
professionals manage your diabetes. You must always rely on your healthcare
professionals to interpret your test results and to decide how to treat your
diabetes.


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