Prodigy VOICE User manual

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
1
Dear PRODIGY Voice System Owner:
This manual contains important information you must know a out the
system. Please read it thoroughly and carefully.
The greatest feature of the Voice system is its speaking function which is an
acoustic aid for users especially with visual disa ility. Please note that this
function is optional.
Another unique feature is its autocode function which means no need
to cali rate your meter, therefore making it easier for you to monitor your
lood glucose at home.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
2
IMPORTANT SAFETY INSTRUCTIONS
READ THIS BEFORE USING
The following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on,
or near children, handicapped persons or invalids.
2. Use the device only for the intended use described in this manual.
3. Do not use strips and control solutions which are not supplied by
the manufacturer.
4. Do not use the device if it is not working properly, or if it has suffered
any damage.
5. 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.
KEEP THESE INSTRUCTIONS

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
3
TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS 03
IMPORTANT INFORMATION 04
ABOUT ATERNATIVE SITE TESTING (AST) 05
INTRODUCTION OF THE SYSTEM 07
Intended Use
Principle of Measurement 07
Contents of the System 08
Appearance and ey Function of the Meter 09
Meter Display Segments 10
Appearance of the Test Strip 11
PREPARATION BEFORE USE 12
Battery Replacement 12
Setting the Meter and Deleting the Memory 14
BEFORE TESTING 18
About Prodigy®Control Solutions 18
Important Control Solution Information 19
How to Perform a Control Solution Test 20
TESTING YOUR BLOOD 23
Testing Procedure 24
Expected Test Results 31
COMPARING METER AND LABORATORY RESULTS 32
USING THE METER MEMORY 33
Viewing Results on the Meter 33
Viewing Results on a Personal Computer 37
CARING FOR YOUR METER AND TEST STRIPS 38
Cleaning 38
Storage 39
PROBLEM-SOLVING GUIDE 41
Special Message 42
Error Message 43
Problem in Operation 45
SPECIFICATIONS 47

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
4
IMPORTANT INFORMATION
• Severe dehydration and excessive water loss may cause false low results. If you believe
you are suffering from severe dehydration, consult your healthcare professional
immediately.
• Test results below 60 mg/dL (3.3mmol/L)*1mean low blood glucose (hypoglycemia). Test
results greater than 240 mg/dL (13.3mmol/L)*2mean high blood glucose (hyperglycemia).
If you get results below 60 mg/dL or above 240 mg/dL, and do not have symptoms, first
repeat the test. If you have symptoms or continue to get results that fall below 60 mg/dL or
above 240 mg/dL, follow the treatment advice of your healthcare professional.
• Apply only capillary whole blood sample to test your blood glucose. Applying other
substances will cause wrong results.
• If you are experiencing symptoms that are not consistent with your blood glucose test
results and you have followed all instructions described in this owner’s manual, consult
your healthcare professional.
• 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.
*1: Kahn, R., and Weir, G.: Joslinís Dia etes Mellitus, 13th ed. Philadelphia: Lea and Fe iger
(1994), 489.
*2: Krall, L.P., and Beaser, R.S.: Joslin Dia etes Manual. Philadelphia: Lea and Fe iger
(1989), 261-263.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
5
ABOUT ALTERNATIVE SITE TESTING (AST)
Important: There are limitations for doing AST.
Please consult your healthcare professional before you do AST.
What is AST?
Alternative site testing (AST) means that people use
parts of the body other than fingertips to check their
blood glucose levels. This system allows you to test on
the palm, the forearm, the upper arm, the calf, or the
thigh with the equivalent results to fingertip testing.
What is the advantage?
Fingertips feel pain more readily because they are full
of nerve endings (receptors). At other body sites, since
nerve endings were not so condensed, you will not feel
as much pain as at the fingertip.
When to u e AST?
Food, medication, illness, stress and exercise can
affect blood glucose levels. Capillary blood at fingertip
reflects these changes faster than capillary blood at
other sites. Therefore when testing blood glucose
during or immediately after meal, physical exercise,
or any other event, take blood sample from your finger only.
We strongly recommend you do AST ONLY in the following intervals:
• In a pre-meal or fasting state (more than 2 hours since the last meal).
• Two hours or more after taking insulin.
• Two hours or more after exercise.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
6
Do NOT use AST if:
• You think your blood glucose is low.
• You are unaware of hypoglycemia.
• Your AST results do not match the way you feel.
• You are testing for hyperglycemia.
• Your routine glucose results are often fluctuating.
• You are pregnant.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has
a significant influence on the glucose value obtained.
Blood from the site without rubbing exhibits a measurably different glucose concentration
than blood from the finger. When the puncture site was rubbed prior to blood extraction, the
difference was significantly reduced.
Plea e follow ugge tion below before getting a drop of blood:
• Rub the puncture site about 20 seconds before puncturing your skin to get enough blood
from the puncture site.
• Use a clear cap (included in the kit) instead of the lancing device cap.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
7
INTRODUCTION OF THE SYSTEM
• Intended Use
The system is intended for use outside the body (in vitro diagnostic use only). It should be
used only for testing glucose (sugar) and only with fresh capillary whole blood samples (from
the finger, the palm, the forearm, the upper arm, the calf and the thigh). 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.
AST in this system can be used only during steady-state blood glucose conditions described
in the “About AST” section.
• Principle of Measurement
The test is based on the measurement of electrical current generated by the reaction of
glucose with the reagent of the strip. The meter measures the current and displays the
corresponding blood glucose level. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
8
• Contents of the System
The Prodigy®Voice system consists of three main products: Prodigy®Voice blood glucose meter,
Prodigy®Voice test strips, and a Prodigy®control solution. These products have been designed,
tested, and proven to work together as a system to produce accurate blood glucose test results.
Use only Prodigy®Voice test strips and Prodigy®control solution with Prodigy®Voice meter.
Your system includes:
1) Prodigy®Voice Meter 7) Daily log book
2) Prodigy®Voice Test strips 8) Lancing device with clear cap for Alternative Site Testing
3) Sterile lancets 9) Warranty card
4) User’s manual 10) (1) Prodigy®Control Solution
5) Carrying case 11) Prodigy®Voice Manual CD (not shown)
6) Quick Reference Guide 12) (2) 1.5v AAA alkaline batteries (not shown)
PLEASE NOTE
1. Check your box to be sure that it is was unopened prior to use, and that it contains all items listed
above. If either of these conditions occurred, please return your system to the place of purchase.
2. There are 2 levels for PRODIGY®control solutions: low and high. Please note that only one control solution
is included in the standard kit, the other is optional. Please ask your local Customer Service for availability.
WARRANTY CARD
Blood Glucose Monitoring System

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
9
• Appearance and Key Function of the Meter
1. LCD DISPLAY- Guides you through the test using symbols and simple messages.
2. STRIP-E ECT BUTTON- The used strip will be ejected after you push up the button.
3. TEST SLOT- Insert the test strip into the slot and the meter will automatically turn on.
4. UP BUTTON-
Is used to increase the value of the current setting and the speaking volume.
5. DOWN BUTTON- Is used to decrease the value of the current setting and the speaking volume.
6. M BUTTON- “M” is also refered to as the main button. Press it to turn on the meter and
enter the memory or perform other functions described in the manual.
7. SET BUTTON- Is used to set up the meter.
8. EARPHONE ACK- Used to the hear results with a earphone (headset).
9. DATA PORT-
Is for cable connection to your personal computer (cable required - sold separately).
10. REPEAT BUTTON- Is used to replay the previous recording that you want to hear again
while operating the meter.
11. BATTERY COMPARTMENT- Where batteries are located.
1
2
11
10
3
4
8
9
5
6
7

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
10
• Meter Display Segments
TEST STRIP
SYMBOL
Appears when the meter
is turned on.
BLOOD DROP
SYMBOL
Flashes when it is
ready to apply the
sample.
VOICE SYMBOL
Indicates if audio
function is on or off.
TEST RESULT AREA
TIME
DATE
Displays glucose results.
A decimal point appears
when the measurement
unit is mmol/L.
LOW BATTERY
SYMBOL
Appears when the
battery power is low.
CTL SYMBOL
Appears when doing a
control solution test.
The result will not be
stored in the memory.
MEASUREMENT
UNIT
Appears with the test
result either in mg/dL
or in mmol/L .
KETONE WARNING
Appears when the
test result is equal or
higher than 240mg/dL
(13.3mmol/L).
MEMORY SYMBOL
Appears when you review
the memory.
DAY AVERAGE
Indicates that the displayed
result is an average.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
11
• Appearance of the Test Strip
Your system measures the amount of sugar (glucose) in whole blood. Blood is applied to the
absorbent channel of the test strip and is automatically drawn into the reaction cell where a
chemical reaction takes place.
The test strip consists of the following parts:
Absorbent Channel
Apply a drop of blood here,
The blood will be drawn up automatically.
Confirmation Window
This is where you confirm if enough blood
has been drawn into the absorbent channel of the strip.
Test Strip Handle
Hold this part to insert the test strip into the meter slot.
Contact Bars
Insert this end of the test strip into the meter.
Push it in firmly until it will go no further.
See pages 24~29, “TESTING YOUR BLOOD”, section for complete instructions.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
12
PREPARATION BEFORE USE
• Battery Replacement
Your meter comes with two (2) 1.5V AAA size alkaline batteries.
The meter will alert you when the power is getting low by
displaying two different messages:
1. The symbol appears together with other display messages: the
meter is functional and the result remains accurate, but it is time to
change the batteries.
Voice SPEAKS: “Battery is low, please replace.”
2. The symbol appears with the “E-b” symbol, “Error” and “low”:
the batteries can not provide enough power to do a test. You must
change the batteries immediately. (Whole screen is blinking).
Voice SPEAKS: “Battery is dead, please replace.”
PLEASE NOTE
• Replacing the batteries does not affect the test results stored in memory. However,
the time, date and unit settings may need to be re-set.
• Batteries might leak chemicals if not used for a long time. Remove the batteries if you
are not going to use the device for an extended period (i.e., 3 months or more).
• Please discard dead batteries properly.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
13
To replace the batteries, make sure that the meter is turned off.
WARNING
As with all small objects, the batteries should be kept away from small children as
a safety precaution. If the batteries are swallowed, seek medical assitance
immediately.
Press the edge of the
battery cover and lift
it up to remove.
1
Remove the old
batteries and replace
with two (2) new
1.5V AAA size
alkaline batteries.
2
Close the battery
cover. If the batteries
are inserted correctly,
you will hear a
“beep” sound.
3

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
14
• Setting the Meter and Deleting the Memory
Your meter comes with the time, date, unit of measurement, unit of temperature preset,
speaking function and memory deletion. If you need to set these parameters, please follow
steps below.
Start with the meter off. Then press and hold the
set button. The meter is now in the settin mode.
You can start settin up the meter.
STEP 1 Set the Year
Press the “Up” or “Down” button until the desired year appears.
Press the S button and then the month segment flashes.
Voice SPEAKS: “You are now in setting mode. he year is 2007.”
STEP 2 Set the Month
Press the “Up” or “Down” button until the desired month appears.
Press the S button and then the day segment flashes.
Voice SPEAKS: “ he month is November”

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
15
STEP 3 Set the Day
Press the “Up” or “Down” button until the desired day appears.
Press the S button and then the hour segment flashes.
Voice SPEAKS: “ he day is the 18th.”
STEP 4 Set the Hour
Press the “Up” or “Down” button until the desired hour appears.
Press the S button and then the minute segment flashes.
Voice SPEAKS: “ he hour is 10 PM.”
STEP 5 Set the Minutes.
Press the “Up” or “Down” button until the desired minute appears.
Press the S button and then the current unit of measurement
flashes.
Voice SPEAKS: “ he minute is 08.”

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
16
STEP 6 Select mg/dL or mmol/L
Press the “Up” or “Down” button to select the unit of measurement
you want to use. Press the S button and then the current unit
of temperature flashes.
WARNING
The milligram per deciliter (mg/dL) is the standard unit in the United States. The millimole
per liter (mmol/L) is the standard unit in Canada. Use of the wrong unit of measure may
cause you to misinterpret your blood glucose level, and may lead to incorrect treatment.
STEP 7 Select “ ºF ” for Fahrenheit or “ ºC ” for Celsius
Press the “Up” or “Down” button to select the unit of temperature
you want to use. Press the S button and the meter will display “VOL”,
“ ” and a flashing number.
Voice SPEAKS: “ emperture unit is degrees Fahrenheit.”
STEP 8 Select Speaking Function & Volume
Press the “Up” and “Down” buttons until you hear the desired
speaking volume. Number 0 indicates that the speaking function
is turned off, where “ ” does not display on LCD during testing.
Number 1 to 7 indicates speaking volume from low to high, where
“ ” displays on LCD during testing. Press the S button and the
meter will display “dEL” with flashing “ ” symbol.
Voice SPEAKS: “Voice volume is 7.”

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
17
STEP 9 Delete the Memory
When “dEL” and blinking “ ” symbol is displayed, if you do not want to delete memory,
press the S button again to skip this step and turn off the meter. If you would like to delete
ALL memory, press the “Up” button twice. “ ”and “ ” are displayed on the meter, which
means that all data stored are deleted. The memory of this meter is empty now. The meter
will automatically turn off.
Voice SPEAKS: “Delete memory record function. Press “up” button to clear all records.
Are you sure you want to delete ALL records? Press “up” button again to
clear all records.”
PLEASE NOTE
• The time, date, unit of measurement and unit of temperature can ONLY be changed in
the setting mode. Therefore, when you perform a glucose testing, it is not possible to
change those parameters.
• Your meter displays 7, 14, 21, 28, 60 and 90 day averages which you can access
from the meter memory. These averages are calculated from results obtained during
the 7, 14, 21, 28, 60 and 90 days preceding the current date and time settings. When
the date and time are changed, the 7, 14, 21, 28, 60 and 90 day averages may change.
• While the meter is in the setting mode, if no button is pressed for 3 minutes, the meter
will turn off automatically.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
18
BEFORE TESTING
• About Prodigy®Control Solutions
PRODIGY®control solutions contain a known amount of glucose that reacts with Prodigy®
test strips. By testing your control solution and comparing the test results with the expected
range printed on the test strip vial label, you can make sure that the meter and the test strips
are working properly together as a system and that you are performing the test correctly. It is
very important that you do this simple check routinely to make sure you get accurate results.
How often should the control solution test be performed?
• When you use this system to test your blood for the first time, practice the procedure using
control solution. When you can do three tests in a row that are within the expected range,
you are ready to test your blood.
• For routinely check the meter and test strips, perform a single test for each level of control
solution at least once a week.
When should the control solution test be performed?
• When you first get your Prodigy®Voice meter.
• When you begin using a new vial of test strips.
• Whenever you suspect that the meter or test strips are not working properly.
• When your blood glucose test results are not consistent with how you feel, or when you
think your results are not accurate.
• When your test strips are exposed to extreme environmental conditions (See “Storage”
section of this manual).
• When you want to practice performing the test.
• If you drop the meter.
• After changing the batteries.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
19
• Important Control Solution 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
(68-77º F/20-25º C) before testing.
• Shake the bottle before use, discard the first drop of control solution after squeezing,
wipe off the dispenser tip to avoid contanimation. These steps ensure you will get a good
sample and an accurate result.
• Use within a period of 90 dyas from the date opened. Record the discard date (date opened
plus 90 days) on the control solution bottle. Discard after 90 dyas.
• Store the control solution tightly closed at temperatures below 86ºF (30ºC).
Do not refrigerate.
PLEASE NOTE
The control solution range printed on the test strip vial is for Prodigy®control solutions only.
It is used to test meter and test strip performance. It is not recommended range for your
blood glucose level.

Blood Glucose Monitoring System - User’s Manual
Diagnostic Devices, Inc www.prodi ymeter.com 1.800.243.2636
20
• How to Perform a Control Solution Test
STEP 1 Insert the Test Strip
Insert a test strip with contact bars end first and facing up, into the test slot. The meter turns
on automatically and displays the followings in sequence:
“CH ” and “ ” “ ” “ ” and flashing “ ”
Voice SPEAKS: “ hank you for using Prodigy Voice.”
est Strip inserted.
oday’s date is ( oday’s date; Example: November 18th, 2007).
he time is ( he time it is at time of test, Example: 10:08AM).
Prodigy Voice works only with the Prodigy Voice test strips.
Please apply blood to the test strip.”