Prodigy Autocode User manual

Blood Glucose Monitoring System
Owner’s Manual
AC Manual Rev. 2 09/09

©2009 Diagnostic Devices, Inc. Prodigy AutoCode® is a registered trademark of DDI. All rights reserved.

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Prodigy Diabetes Care, LLC 1.800.243.2636
Prodigy 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 toll
free 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,
accurate results with a minimal sample of blood. It has a
large easy to read screen display and is small, 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 Alternate Site Testing (AST).
• Has memory and data management capabilities.
Prodigy® meter’s free software gives you and your
healthcare professionals powerful graphic tools to
manage your diabetes.

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Prodigy Talking Meter Owner’s Manual
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Important Safety Instructions .......................................... 4
Important Health-Related Information .............................. 5
About Alternate 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
Table of Contents

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Prodigy Talking Meter Owner’s Manual
Blood Glucose Testing ...................................................24
Preparing the Lancing Device ........................................ 24
Getting a Blood Sample ................................................ 26
Performing a Blood Glucose Test .................................. 28
Using the Meter Memory ............................................... 30
Viewing Results on a Personal Computer ....................... 32
Caring for your Prodigy AutoCode® Meter ........................ 34
Maintenance ................................................................ 34
Battery .......................................................................34
Battery Replacement .................................................... 35
System Troubleshooting ................................................ 36
Special Messages ........................................................ 36
Error Messages ...........................................................37
Troubleshooting Guide .................................................. 38
Information about your Prodigy AutoCode® Meter ........... 40
Comparing Meter and Laboratory Results ...................... 40
Specifications ............................................................... 42
Performance Characteristics ......................................... 43
Expected Test Results .................................................. 44
Accuracy of Meter Measurements ................................. 45
Table of Contents

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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.
Important Safety Instructions

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Prodigy Talking Meter Owner’s Manual
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; 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.
Please refer to your test strip package insert for additional
important information.
Important Health-Related Information

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There are important limitations to AST. Please consult your
healthcare professional before you perform AST.
What is AST?
Alternate 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.
About Alternative Site Testing (AST)
Figure 1
About Alternate Site Testing (AST)

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Prodigy Talking Meter Owner’s Manual
Use AST only:
v Two hours or more after your last meal
v Two hours or more after taking insulin
v Two hours or more after exercise
v During steady state blood glucose conditions
Do not use AST if:
vYou have reason to believe you have hypoglycemia or
  hyperglycemia
vYour routine glucose results are often fluctuating
vYou are pregnant
*To increase the accuracy when using AST, rub the puncture
site before extracting blood.

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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.
Introduction to the Prodigy AutoCode® Meter

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Prodigy Talking Meter Owner’s Manual
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 #70120 or REF #51890
Your “Meter Kit” includes:
• Prodigy AutoCode®
Talking Meter
• Two (2) AAA Batteries
• Prodigy® Control
Solution (4ml)
• Prodigy® Test Strips (10ct)
• Sterile Lancets (10ct)
• Lancing Device
• Complete Instructions:
- Manual
- Log Book
- Quick Reference
- Warranty Card
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:
Important: Please review the contents of your purchase.
If any items are missing, please return your meter to the
place of purchase.
Contents of the Prodigy AutoCode® Meter

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Test Strip 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.
Set Button
Located on the back of the meter, inside the battery
compartment; used to setup the meter.
Data Port
Port for USB Cable connection to your computer.
Main Button
Turns the meter on or performs other
functions described in this manual. Figure 2
Key Functions of the Meter

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Prodigy Talking Meter Owner’s Manual
Control Solution
Test Symbol
Shows that you are in
Control Solution Mode.
Test Result
Area
Displays
test results.
Blood
Drop Symbol
Flashes when
sample should
be applied.
Test Strip
Symbol
Appears
when the
meter is
turned on.
Unit of Measure
Indicates what
unit of measure
the test result is
displayed in.
Low Battery
Symbol
Appears
when the
battery
power is low.
Voice Symbol
Shows if audio
function is on.
Temperature
Symbol
Appears when
ambient
temperature
is outside
of operating
range.
Memory
Symbol
Appears when
you review the
memory.
Day Average
Indicates that the
displayed test
result is an average.
Time Date
Meter Display
Figure 3
Setting Up the Prodigy AutoCode® Meter

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Prodigy Talking Meter Owner’s Manual
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The Prodigy AutoCode® Meter talks you through each step of
your testing procedure.
When does the
meter speak?
When the meter is
turned on.
When room temperature is
outside operating range;
which is 50°F–104°F
(10°C–40°C).
When the meter is ready to
test.
( appears on display)
When the test is completed.
(The result appears on
display)
When you turn off the meter.
When a used test strip is
inserted.
What does the
meter say?
Your Prodigy® Meter is on.
Room temperature is out of
range.
Please apply blood to the
strip.
Your blood glucose is
(number) milligrams per
deciliter/millimoles per liter.
Goodbye.
Test strip has been used.
Speaking Function

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Prodigy Talking Meter Owner’s Manual
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:
Please refer to the “Performing a Blood Glucose Test”
Section for complete instructions.
Key Functions of the Test Strip
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. Figure 4

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• Store test strip packages in a cool, dry place between
39.2°F–104°F (4°C–40°C). 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.
• 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.
Important Test Strip Information

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Prodigy Talking Meter Owner’s Manual
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
Press and hold the “SET” button located in
the battery compartment. The meter is now
in the setup mode.
Voice Speaks: “Your Prodigy® meter is on.
Please wait. Setting mode. English.”
STEP 2: Select Language
The language option appears first with
“L-1” on the LCD. By default, “L-1”
indicates default language (English);
“L-2” indicates second language (Spanish);
“L-3” indicates third language (French); and
“L-4” indicates fourth language (Arabic).
See Figure 5.
Press the “M” button to select language. With the correct
language on the display, press the “SET” button and a
number will appear.
Set-Up Steps
Figure 5

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STEP 3: Setting Volume Level
The meter displays a number.
• Number 0 indicates that the speaking
function is turned off.
• Numbers 1 to 3 indicate speaking volume
from low to high, where “ ” is displayed
on the LCD during testing.
See Figures 6 and 7.
Press the “M” button to select the speaking
volume. Then press the “SET” button and
the year segment will appear and
start flashing.
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 8.
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 9.
Figure 8
Figure 9
Figure 6
Figure 7

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Prodigy Talking Meter Owner’s Manual
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 10.
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 11.
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 12.
Important: Day averages are calculated from results
obtained during the 7, 14 and 28 days preceding
the current date and time settings.
Figure 12
Figure 10
Figure 11

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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 13 and 14.
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
“ ” 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 “ ” will flash. Press the “M”
button again to delete ALL memory. The
“- - -” will appear to indicate all memory has
been deleted and the meter will turn off.
See Figure 15.
Set-up is now completed. Press the “SET”
button. “OFF” is displayed and the meter
turns off. See Figure 16.
Figure 15
Figure 16
Figure 13
Figure 14