Prodigy Autocode User manual

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Owner’s Manual
AutoCode®Blood Glucose Meter
2
Dear Prodigy AutoCode
®
Meter Owner:
Thank you for choosing the Prodigy AutoCode
®
as your
blood glucose monitoring system. Please read this
manual carefully as it contains important information
about your new Prodigy AutoCode
®
system.
The Prodigy AutoCode
®
meter has the latest technol-
ogy for blood glucose monitoring and is made with
quality components. It is easy to use, provides fast test
results with a minimal sample of blood, has a large,
easy-to-read display screen, and is lightweight and
portable for your convenience.
The Prodigy AutoCode
®
meter is designed to help you
and your healthcare professionals monitor your blood
glucose levels. This Owner’s Manual will help you learn
how to use your Prodigy AutoCode
®
meter effectively.
A warranty registration card is included with your
system. Please return the completed card to us, com-
plete the warranty online at www.prodigymeter.com,
or call Customer Care to register your Prodigy Auto-
Code
®
meter. Customer Care is available by calling
1.800.243.2636 Monday - Friday 8:30AM to 5:30PM
(EST). All questions concerning test results should be
directed to your healthcare professional.

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
3
Prodigy AutoCode
®
meters:
• Require No Coding, allowing you to save time
and decreases the chances of human error due
to improper coding.
• Allow you to perform Alternate Site Testing (AST).
• Have memory and data management capabilities.
Prodigy’s Diabetes Management software gives you
and your healthcare professional, powerful graphic
tools to manage your diabetes.

Owner’s Manual
AutoCode®Blood Glucose Meter
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Letter to Meter Owner................................................................2-3
Table of Contents.........................................................................4-5
Important Safety Instructions....................................................6-9
Important Health-Related Information .................................... 10
Alternate Site Testing (AST).................................................. 11-12
Introduction to Prodigy AutoCode®Meters...................... 13-14
Intended Use .......................................................................... 13
Test Principle..................................................................... 13-14
About Prodigy No Coding Blood Glucose Test Strips.... 14-16
Key Functions of the Test Strip ...................................... 14-15
Important Test Strip Information................................... 15-16
Contents of the Prodigy AutoCode®Meter............................. 17
Setting up the Prodigy AutoCode®Meter......................... 18-27
Key Functions.......................................................................... 18
Meter Display.................................................................... 19-20
Speaking Function................................................................. 21
Setup Steps....................................................................... 22-27
Control Solution Testing........................................................ 28-34
Performing a Control Solution Test .............................. 31-34
Performing a Blood Glucose Test........................................ 35-44
Preparing the Lancing Device....................................... 35-36
Getting a Blood Sample................................................. 37-38
Tips for Applying Blood Without Sight ....................... 39-41
Applying Blood to the Test Strip................................... 42-44
Table of Contents

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
5
Using the Meter Memory...................................................... 45-47
Viewing Results on a Personal Computer ............................... 47
Specications................................................................................. 48
Caring for your Prodigy AutoCode®Meter ....................... 49-54
Cleaning your System..................................................... 50-51
Lancing Device....................................................................... 51
Disinfecting your System................................................ 51-52
Storing your System .............................................................. 52
Battery...................................................................................... 53
Low Battery.............................................................................. 53
Battery Replacement............................................................. 54
System Troubleshooting........................................................ 55-61
Special Messages ............................................................ 55-56
Error Messages................................................................. 56-57
Troubleshooting Guide .................................................. 58-61
Information About your Prodigy AutoCode®Meter........ 62-71
Comparing Meter and Laboratory Results................. 62-63
Performance Characteristics.......................................... 64-65
Expected Test Results............................................................ 66
Unexpected Test Results ................................................ 67-68
Accuracy of Meter Measurements ............................... 69-71
Symbol Information...................................................................... 72
Warranty Information................................................................... 73
Limited Lifetime Warranty.................................................... 73
Table of Contents

Owner’s Manual
AutoCode®Blood Glucose Meter
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READ ALL INSTRUCTIONS THOROUGHLY BEFORE USING.
The following basic safety precautions should always
be taken.
• Close supervision is necessary when the device is used
by, on, or near children and handicapped persons.
• Use the device only as described in this manual.
• Use only Prodigy No Coding Blood Glucose Test
Strips and Prodigy Control Solution with your Prodigy
AutoCode
®
meter. Using other test strips and control
solutions with this meter can produce inaccurate re-
sults.
• Do not use the device if it has suffered any damages
or if it appears to not be working properly.
• Keep the test strip vial away from children; the vial cap
and test strips can be a potential choking hazard.
• Never chew or swallow a test strip. If this occurs, seek
medical assistance immediately.
• All parts of the system are considered biohazardous
and can potentially transmit infectious diseases, even
after cleaning and disinfection.
Important Safety Instructions

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
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• The device is intended for patient over-the-counter
use to self-monitor blood glucose. It should not be
used to collect blood from more than one person.
• The meter and lancing device are for single patient
use. Do not share them with anyone including other
family members! Do not use on multiple patients!
• To reduce the risk of electromagnetic interference,
DO NOT use this meter near cellular and cordless
telephones, intercom systems, electric garage gates,
radio transmitters and other electrical or electrical
equipment that are sources of electromagnetic radi-
ation, which may interfere with the meter’s operation.
For further information, please refer to:
FDA Public Health Notication: Use of Fingerstick
Devices on More Than One Person Poses Risk for
Transmitting Bloodborne Pathogens: Initial
Communication (2010) http://www.fda.gov/MedicalDevices/
Safety/AlertsandNotices/ucm224025.htm
CDC Clinical Reminder: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens (2011)
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Important Safety Instructions

Owner’s Manual
AutoCode®Blood Glucose Meter
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Limitations
Hematocrit: Hematocrit levels below 20% or above 60%
can cause false results. Please consult your healthcare
professional if you do not know your hematocrit level.
For self-testing only.
For in vitro diagnostic use only.
Do not share your Prodigy AutoCode
®
meter, test strips,
lancets and lancing device with anyone, including other
family members.
Do not use on multiple patients.
The system should NOT be used for the diagnosis of or
screening for diabetes.
The system should NOT be used in neonates.
The system should NOT be used on critically ill patients.
Not for use on patients who are dehydrated,
hypotensive, in shock or in a hyperosmolar state.
DO NOT CHANGE YOUR TREATMENT BASED ON
A SINGLE RESULT THAT DOES NOT MATCH WITH
HOW YOU FEEL, OR IF YOU BELIEVE THAT YOUR
TEST RESULT COULD BE INACCURATE.

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
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Alternate Site Testing results should NOT be used
for calibrating CGMs or for insulin dosing calcula-
tions when glucose levels may be rapidly changing or
uctuating, such as after meals or exercise, or after tak-
ing insulin.
Do not use the Prodigy AutoCode
®
Blood Glucose Mon-
itoring System during or after a Xylose Absorption Test.
This may falsely raise glucose results. Please check with
your Doctor before using the Prodigy AutoCode
®
Blood
Glucose Monitoring System.
The system exhibits interference from Acetaminophen,
ascorbic acid and Ibuprofen. If you are taking acet-
aminophen containing drugs (Tylenol, etc., >8.0 mg/
dL in your blood), or ibuprofen containing drugs (Advil,
etc., > 50.0 mg/dL in your blood) or vitamin C (ascor-
bic acid, > 5.0 mg/dL in your blood), you may obtain
inaccurate readings from this blood glucose monitoring
system. Please check with your doctor before using the
Prodigy Autocode
®
Blood Glucose Monitoring System.
High uric acid concentrations (>8 mg/dL in your blood)
may interfere with the glucose measurements with
this device. If you have medical conditions that are
associated with high uric acid level or hyperurice-
mia (e.g. gout), then please check with your Doctor
before using the Prodigy AutoCode
®
Blood Glucose
Monitoring System.

Owner’s Manual
AutoCode®Blood Glucose Meter
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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) indi-
cate high blood glucose (hyperglycemia).
If your test result is below 60 mg/dL or above 240 mg/
dL, repeat the test, and if the result is still below 60 mg/
dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L),
consult with your healthcare professional immediately.
Inaccurate results may occur in severely hypoten-
sive individuals, individuals in shock, and in those
experiencing a hyperglycemic-hyperosmolar state.
Please refer to the test strip package insert for
additional important information.
Severe dehydration and excessive water loss may
cause false low results. If you believe you are suffering
from severe dehydration, consult with a healthcare pro-
fessional immediately.
If you are experiencing symptoms that are not
consistent with your blood glucose test results and
you have followed all instructions described in this own-
er’s manual, contact your healthcare professional.
Important Health-Related Information

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
Figure 1
11
There are important limitations to performing AST.
Consult with your healthcare professional before testing
with a blood sample obtained from AST locations.
Alternate Site Testing
What is AST?
Alternate Site Testing (AST)
means you can use parts of the
body other than your ngertips
to check your blood glucose
levels. The system allows you
to test from the palm, forearm,
upper arm, calf or thigh, with
equivalent results to ngertip
testing.
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 ngertip.

Owner’s Manual
AutoCode®Blood Glucose Meter
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When to use AST?
Food, medication, illness, stress and exercise can affect
blood glucose levels. Capillary blood at ngertip re-
ects these changes faster than capillary blood at other
sites. Therefore, if you are testing blood glucose levels
during or immediately after a meal, physical exercise or
stressful event, take the blood sample from your nger-
tip only.
Use AST only:
• In a pre-meal or fasting state (more than 2 hours after
the 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:
1. You have reason to believe you have hypoglycemia
or hyperglycemia.
2. Your routine glucose results are often uctuating.

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
13
Intended Use
The Prodigy AutoCode
®
Blood Glucose Monitoring
System is intended to be used for the quantitative
measurement of glucose (sugar) in fresh capillary
whole blood samples drawn from the ngertips,
forearm, upper arm, palm, calf or thigh.
The system is intended for self-testing outside the
body (in vitro diagnostic use) by people with diabetes
and is an at-home aid to monitor the effectiveness of
diabetes control. It should not be used for the diagno-
sis or screening of diabetes or for neonatal use.
Test Principle
Blood glucose is measured by an electrical 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, calcu-
lates the blood glucose level and then displays the
result in milligrams per deciliter (mg/dL) or millimoles
per liter (mmol/L). (USA standard: mg/dL)
Introduction to Prodigy AutoCode®Meters

Owner’s Manual
AutoCode®Blood Glucose Meter
14
The Prodigy AutoCode®meter, test strips and control
solution has been designed, tested and is proven to
work together as a system to produce accurate blood
glucose test results.
Important:
Use only Prodigy No Coding Blood Glucose Test Strips
and Prodigy Control Solution with your Prodigy AutoCode®
meter. Using other test strips and control solutions with this
meter can produce inaccurate results.
About Prodigy No Coding Blood Glucose Test Strips
Key Functions of the Test Strip
The Prodigy AutoCode®meter measures the amount
of sugar in the blood, commonly referred to as blood
glucose. Blood is applied to the opening of the
absorbent channel on the end of the test strip and
is automatically drawn into the test strip.

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
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1. Absorbent Channel: Apply a drop of blood here.
2. Conrmation Window: To conrm if enough blood
is applied or has been drawn into the strip.
3. Test Strip Handle: Hold this part to insert the test strip
into the test strip slot.
4. Contact Bar: Insert this end into the test strip slot.
1
2 4
Please refer to the “Performing a Blood Glucose Test”
section for complete instructions.
Important Test Strip Information
• Store test strip packages in a cool, dry place
between 39.2°F–104°F (4°C–40°C) and 10-85% rel-
ative humidity.
• Do not freeze.
• Keep away from direct sunlight and heat.
(Do not store in your car.)
• Store your test strips in their original vial only. Do not
transfer them to a new vial or any other container.
P R O D I G Y®
3

Owner’s Manual
AutoCode®Blood Glucose Meter
16
• Close the test strip’s vial lid immediately after
removing a strip, and use each strip promptly.
• 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.
• Wash the test site thoroughly with soap and water.
• Record the discard date on the vial label when you
rst open it. Discard remaining test strips 90 days af-
ter the rst opening date.
• Do not use test strips beyond the expiration date
printed on the package.
• After removing the test strip from the vial, insert it di-
rectly into the meter. Do not lay the test strip on any
other surface.
Warning: Keep the test strip vial away from chil-
dren; the vial cap and the test strips can be a po-
tential choking hazard. Never chew or swallow
a test strip. If this occurs, please seek medical
assistance immediately.

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
17
Contents of the Prodigy AutoCode®Meter
Please review the contents of your purchase to conrm
that all the components are included as listed on the
side of your meter box.
You will need the following items to test your blood glu-
cose levels:
1. Prodigy AutoCode®Blood Glucose Meter
2. Prodigy No Coding Blood Glucose Test Strips
3. Lancets
4. Lancing Device
5. Prodigy Control Solution
If any item is not included in the box, please
purchase it separately. Please contact Customer
Care at 1.800.243.2636.

Owner’s Manual
AutoCode®Blood Glucose Meter
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Test Strip Slot
Insert the test strip here.
The meter will turn on automatically.
LCD Display Screen
Shows test results and messages.
M Button
Turns the meter on and performs other
functions described in this manual.
USB Data Port
USB cable connection to your computer.
Set Button
Used to set up the meter. Located
on the back of the meter, inside
the battery compartment.
Setting Up the Prodigy AutoCode®Meter
Key Functions

Owner’s Manual
AutoCode®Blood Glucose Meter AutoCode®Blood Glucose Meter
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Figure 4
mg/dL
mmol/L
Time Date
Meter Display
Test Result Area
Test Strip Symbol
Appears when
the meter is in
testing mode.
Blood Drop Symbol
Flashes when sample should
be applied.
Unit of Measure
Indicates the test result unit
of measure. Default value: mg/dL.
Control Solution Symbol
Appears when set to control solution mode.

Owner’s Manual
AutoCode®Blood Glucose Meter
20
Figure 5
mg/dL
mmol/L
Meter Display
Day Average
Indicates that the
displayed test result
is an average. Memory Symbol
Appears when
reviewing the
memory.
Temperature
Symbol
Appears when
temperature is
outside of the
operating range.
Low Battery
Symbol
Appears when
the battery power
is low.
Voice Symbol
Shows if audio
function is on.