Prodigy Voice Glucose Meter Manual

Headings have Been Added To Assist in Navigation. Page numbers appearing in the headings correspond to the page numbers in the printed manual.

Welcome

2008-06-23

Dear Prodigy Voice Meter Owner:
Thank you for purchasing the Prodigy Voice Meter, one of the best blood glucose monitoring systems on the market and one designed with the needs of blind and visually impaired diabetics in mind. The Prodigy Voice Meter manual contains important information you must know about the system. Please read it carefully before operating the meter.

This manual provides instructions that guide you through how to operate the Prodigy Voice Meter system. One of Prodigy Voice's greatest features is its speaking function, which guides the user through all aspects of use of the Prodigy Voice Meter. Setting up the meter, performing blood glucose tests and using the memory features are all completely accessible without vision. Another unique feature is its auto-coding function which means there is no need to calibrate your meter each time a new vial of test strips is opened.

Basic Safety Precautions

Please note that the following basic safety precautions should always be taken.
1. Close supervision is necessary when the device is used by, on, or near children.
2. Use the device only for the intended use described in this manual.
3. Do not use test 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, you should consult with a diabetes healthcare professional, understand all instructions completely, practice the blood glucose test, and perform all quality control checks as directed.

Contents:

Section 1: Important Information before Use Page 3
Section 2: Intended Use Page 4
Section 3: Limitations of Use Page 5
Section 4: Contents of the Prodigy Voice Kit Page 6
Section 5: Orientation to the Prodigy Voice Meter Page 7
Section 6: How to Take Care of the Meter Page 8
Section 7: Orientation to the Prodigy Voice Test Strips Page 9
Section 8: Handling and Storing the Test Strips Page 10
Section 9: Using the Prodigy Control Solutions Page 11
Section 10: Handling and Storing the Prodigy Control Solutions Page 12
Section 11: How to Change the Batteries Page 13
Section 12: How to Set up the Meter and Delete the Memory Pages 14 and 15
Section 13: How to Perform a Control Solution Test Pages 16 and 17
Section 14: Applying a Blood Sample to the Test Strip without Vision Pages 18 and 19
Section 15: Testing Your Blood Glucose Pages 20, 21 and 22
Section 16: How to Read Your Blood Glucose Test Results Page 23
Section 17: Reviewing the Historical Results from the Meter Memory Page 24
Section 18: Transmitting Historical Results to Your Computer Page 25
Section 19: How Does the Meter Report Error Messages Page 26
Section 20: Problem Solving Tips and Solutions When Operating the System Page 27
Section 21: About Alternative Site Testing (AST) Page 28

Section 1: Important Information before Use Page 3

The following is important information you should know before testing your blood glucose. If you have questions, please contact Technical Support at 1-800-243-2636 or consult your healthcare professional for help.

1. Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, please consult your healthcare professional immediately.

2. Test results below 72 milligrams per deciliter or 4.0 millimoles per liter mean "hypoglycemia" or low blood glucose levels in the blood stream. Test results greater than 240 milligrams per deciliter or 13.3 millimoles per liter mean "hyperglycemia" or high blood glucose levels in the blood stream. If either one of the above conditions occurs, please repeat the test and follow the directions of your healthcare professional.

3. If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this manual, please consult your healthcare professional.

4. This system provides Alternative Site Testing, or AST. Please refer to "Section 21 - About Alternate Site Testing" for details. Please consult your healthcare professional before performing Alternate Site Testing.

Section 2: Intended Use Page 4

The Prodigy Voice system is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose or sugar in the blood, 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.

This system can be used for Alternative Site Testing only during stable blood glucose conditions described in "Section 21 - About Alternative Site Testing".

Section 3: Limitations of Use Page 5

The following is important information you should know before testing your blood glucose. If you have questions, please contact Technical Support at 1-800-243-2636 or consult your healthcare professional for help.

1. Red blood cell count or hematocrit that is very high (above 60%) or very low (below 20%) can cause false test results. Please consult your healthcare professional if you do not know your hematocrit percentage level.

2. Some drugs affect blood glucose levels. Uric acid, ascorbic acid, acetaminophen, dopa, methyldopa, L-dopa and tolbutamide at normal blood concentration levels do not significantly affect blood glucose test results. However, high concentrations of the above substances may cause inaccurate test results. Blood glucose readings should be interpreted with caution in such cases. Please consult your healthcare professional.

3. Elevated blood triglycerides up to 2,000 milligrams per deciliter or 22.58 millimoles per liter do not significantly affect the blood glucose test results. However, the blood glucose test may be affected by levels above 2,000 milligrams per deciliter or 22.58 millimoles per liter.

4. This system may be used at altitudes up to 10,742 feet or 3,275 meters without any effect on test results.

Section 4: Contents of the Prodigy Voice Kit Page 6

The Prodigy Voice system consists of three main products: the Prodigy Voice Blood Glucose Meter, Prodigy Voice Test Strips, and 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 with the Prodigy Voice Meter. Do not use Prodigy Autocode Test Strips or Prodigy Audio Test Strips with the Prodigy Voice Meter. Make sure your healthcare professional writes prescriptions for Prodigy Voice Test Strips only. Additionally, only use Prodigy Control Solution with the Prodigy Voice Meter.

Your system includes: a Prodigy Voice Meter, a vial of ten Prodigy Voice Test Strips, a lancing device, a clear cap for Alternative Site Testing, a small plastic packet of sterile lancets, a bottle of Prodigy Control Solution, a Prodigy Voice Manual in both audible and print formats, a carrying case, and a piece of paper which is your warranty card.

When you receive the package, please check and make sure each part is included and unopened. If there are any questions, please contact Technical Support at 1-800-243-2636 for help.

Section 5: Orientation to the Prodigy Voice Meter Page 7

The Prodigy Voice Meter is a U-shaped device. To begin exploring your new Prodigy Voice Meter, place the meter on a table or hold it in one hand in front of you with the rounded side towards you and the buttons facing up.

The top of the meter is a straight edge. Five buttons are located on the front of the meter. On the front panel on the right hand side are two raised triangle shaped buttons. The triangle shaped button on the top right hand side faces upward and is the "Up" button. When setting up the meter it can be used to advance you through the different setting options. Underneath the first raised triangle button, is another raised triangle button which faces downward and is the "Down" button. This button can be used to reverse you through the setting options. These triangle shaped buttons can also be used to adjust the speaking volume.

Across the bottom part of the meter are three buttons. The large round button on the right hand side has a raised letter "M" on it and is the "Main" button, also referred to as the "M" button. The "M" button can be used to check the historical test results in the meter's memory or it can also be used to turn off the meter by holding down the "M" button for 5 seconds. The button to the left of the "M" button is the "Set" button. It is bullet shaped and has a raised letter "S" on it. It is used to put the meter in set mode. To the left of the "Set" button, there is another bullet shaped button with a raised arrow on it pointing to the left. This is the "Repeat" button. The "Repeat" button is used to replay the last spoken message. While powered on, the "Repeat" button may be pressed at any time to have the last spoken message repeated. While the meter is off, pressing the "Repeat" button causes the Prodigy Voice to announce the current date and time.

The LCD window is located on the upper left hand side on the front panel of the meter. When performing a blood glucose test, it will display the time and date on the lower part of the display window and the test results above in the upper part of the display window.

The sides of the meter contain four additional functions. The first function is the test slot which is located on the top side panel of the meter in the middle. It also has an indentation above the slot to help you locate the test slot. This is where you insert the test strip to perform a blood glucose test.

The second function, on the left side, is a sliding button called the "Strip-Ejection" button. Pushing up the button will eject the test strip from the meter. *Please Note: The springs on this button are very strong, so make sure it is pointed into a disposal container.

The last two functions are the earphone jack and data port. They are located on the round side of the meter. The earphone jack, located to the right of the data port, is a hole where you insert a pair of 1/8 inch standard earphones. The data port is covered by a flexible plastic flap with the raised capital letters "PC" on it. This port is used to connect the meter to a computer through a cable and then transmit the stored test results to the computer. The flap is opened by placing your fingernail under the right edge of the flap and gently pulling to the left. The left side of the flap is anchored in place so the flap does not fall off when open. Keep this flap closed to prevent dirt and moisture from entering the internal section of the meter.

Now turn the meter over to explore the bottom side. You will feel a rectangle shaped section in the middle which is the battery cover. Underneath the cover you will find two AAA Alkaline batteries in the battery compartment. There is a buckle at the lower part of the battery cover near the round end. To remove the battery cover, push the buckle away from you by placing the fingernail of your thumb against the edge of the buckle closest to the round edge and applying pressure towards the cover and up. Please refer to "Section 11 - How to Change the Batteries" for instructions on replacing the batteries.

Section 6: How to Take Care of the Meter Page 8

Your meter does not require special maintenance. As long as no blood or control solution comes in contact with the internal part of the meter, no special cleaning is required. Take care to avoid getting dirt, dust, blood, control solution or water inside the meter through the test slot or data port. Store the meter in its carrying case after each use. In terms of temperature, it may be kept in most environments except in bitter cold or extreme heat. The meter should never be kept where the temperature is not between -4° Fahrenheit to 140° Fahrenheit or -20° Celsius to 60° Celsius. Please Note: Although the meter can withstand these temperature extremes without damage to the meter itself, the temperature of the meter must return to around room temperature for accurate results to be produced. In general, keep the meter as close to room temperature as conveniently possible. Please avoid direct sunlight, high humidity, dropping the meter, or strong impacts to the meter. A cloth dampened with water and mild detergent can be used to wipe down the outside of the meter. Never douse or flush the meter with water or organic solvents to clean the meter. Your meter is a precision instrument; please handle it with care.

Section 7: Orientation to the Prodigy Voice Test Strips Page 9

The Prodigy Voice Test Strips are packed in round vials with a flip up cap. Please Note: Only Prodigy Voice Test Strips can be used with the Prodigy Voice Meter. Prodigy Audio and Prodigy Autocode Test Strips are not designed to work with the Prodigy Voice Meter. The Prodigy Voice Test Strip is approximately 1.3 inches or 3.3 centimeters long and is square at one end, and rounded at the other. The square end also has an easily felt ridge on top near the end. The square end is inserted into the meter when performing a test. The test strip must be inserted with the ridge facing up and the test strip placed flat against the bottom or floor of the test slot. The test strips are packed in the vial with the square end up. When taking a test strip out of the vial, you will be grabbing the square end which is the end to be inserted into the test strip slot. One of the great features of the Prodigy Voice Test Strip is that they may be touched all over.

The round end of the test strip is where you apply your blood sample. There is an absorbent opening at the rounded tip, and it contains a chemical reagent that reacts with the glucose in the blood sample. When the tip touches a blood sample, blood is automatically drawn into the opening where the reaction takes place.

Principle of Measurement:

The test is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the test strip. The meter measures the electrical current and displays the corresponding blood glucose level. The strength of the electrical current produced by the reaction depends on the amount of glucose in the blood sample.

Section 8: Handling and Storing the Test Strips Page 10

Please adhere to the following instructions to help store and handle your test strips safely and without damage.

1. The test strips can be stable for 90 days, or three months, after opening the vial. Write down or record the date you open the vial and discard remaining test strips after 90 days. Never use the expired test strips.

2. Only touch the test strip with clean and dry hands.

3. Use the test strip immediately after taking it out from the vial.

4. Apply the blood sample only to the absorbent opening. Applying blood to other areas on the test strip such as the straight end containing the contact bars can cause inaccurate results. Other substances on the hands during the test such as hand lotion will also cause inaccurate test results.

5. The test strips should be stored at room temperatures of 39°Fahrenheit to 104°Fahrenheit or 4°Celsius to 40°Celsius and below 85 percent relative humidity. Do not refrigerate the test strips. Please Note: The Prodigy Voice Test Strips cannot withstand nearly the same temperature extremes as the Prodigy Voice Meter itself.

6. Always store your test strips in the original vial. Do not transfer the test strips to other containers. After removing a test strip from the vial, immediately close the vial cap tightly; you will hear it snap into place.

7. The test strip vial should be stored in a cool and dry place. Avoid exposing the test strips to direct sunlight and heat.

8. Keep the test strip vial away from children as the cap and the test strips can be a potential choking hazard. If swallowed, promptly see a doctor for help.

Section 9: Using the Prodigy Control Solutions Page 11

The Prodigy Control Solutions contain a known amount of glucose that reacts with the Prodigy Voice Test Strips in the same way as a blood sample. By comparing your control solution test results with the expected range, you are able to check that the meter and the test strips are working together as a system and that you are performing the test correctly. The expected range for each vial of Prodigy Voice Test Strips is printed on the back of the label on each vial.

It is recommended that you perform a test with the control solution at least once a week to check the performance between the meter and test strips. If any one of the following conditions occurs, you should perform the control solution test before testing your blood glucose.

1. When you first get your blood glucose meter, practice testing with the meter using the control solution. Develop a technique for consistently applying a sample on your finger to the absorbent opening of the test strip by following the instructions in "Section 14 - Applying a Blood Sample to the Test Strips without Vision". When you can do three tests in a row that are within the expected range, you are ready to test your blood glucose.

2. Whenever you suspect that the meter or test strips are not working properly.

3. When your blood glucose test results are not consistent with how you feel, or when you think your test results are not correct.

4. When your test strips are exposed to extreme temperatures or humidity.

5. When you want to practice running the test.

6. If you drop the meter.

Section 10: Handling and Storing the Prodigy Control Solutions Page 12

Please adhere to the following instructions to store and handle your Prodigy Control Solution without damage.

1. Use only Prodigy Control Solutions to check the performance between the meter and the test strips.

2. Use the Prodigy Control Solution for 90 days, or three months, after first opening the control solution. Write down or record the date you open the control solution and discard after 90 days.

3. The control solution, meter, and test strips should come to room temperature before testing. Always store the control solution tightly closed at temperatures below 86° Fahrenheit or 30° Celsius. Do not refrigerate.

4. Shake the bottle, discard the first drop of control solution, and wipe off the dispenser tip with tissue paper or cotton to ensure a good sample and a correct test result.

5. The control solution range printed on the label of the test strip vial is for Prodigy Control Solution tests only. It is used to test the meter and test strip performance. It is not a recommended range for your blood glucose level.

6. Keep the bottle of control solution away from children as the cap and the bottle can be a potential choking hazard. If swallowed, promptly see a doctor for help.

Section 11: How to Change the Batteries Page 13

Your meter comes with two AAA Alkaline batteries. The meter will alert you when the power is getting low by announcing two different voice messages.

When the batteries are getting low, you will hear:
"Battery is low, please replace."
This message indicates that it is time to change the batteries but the meter remains functional.

When the batteries are dead, you will hear:
"Battery is dead, please replace."
This message indicates that you must change the batteries immediately.

To change the meter batteries, please turn the meter over to explore the bottom side. You will feel a rectangle shaped section in the middle which is the battery cover. Underneath the cover, you will find two AAA Alkaline batteries in the battery compartment. There is a buckle at the lower part of the battery cover near the round end of the meter. To remove the battery cover, push the buckle away from the round end of the meter by placing the fingernail of your thumb against the edge of the buckle closest to the round edge and applying pressure towards the cover and up.

When you install new batteries, connect the negative terminal of the battery which is the flat end to the spring in the compartment. One battery is positioned with the negative side down and the other battery is positioned with the negative side up. When batteries are correctly positioned, you will hear a beep sound.

Please note the following:
1. Replacing the batteries does not affect the test results stored in memory.
2. If you are not going to use the meter for an extended period of time, for example, three months or longer, please remove the batteries as they may begin to leak chemicals.
3. As with all small objects, the batteries should be kept away from small children. Please discard the batteries carefully, as they can be a potential choking hazard. If swallowed, promptly see a doctor for help.

Section 12: How to Set up the Meter and Delete the Memory Page 14 and 15

Your meter's setting options include the time, date, unit of measurement and memory deletion.

To enter setting mode, with the meter off, press down and keep holding the "Set" button until you hear a voice message
"You are now in setting mode."

Once in setting mode, anytime you wish to exit, press down and keep holding the "Set" button until you hear:
"Have a nice day!"
or instead, simply leave the meter alone without pressing any buttons for three minutes. The ending music plays and the meter will turn off automatically.

After the meter reports:
"You are now in setting mode."
you will hear the meter report the year. Press the "Up" or "Down" buttons until you hear the desired year.
Press the "Set" button to confirm the year and you will hear the meter report the month. Press the "Up" or "Down" buttons until you hear the desired month.
Press the "Set" button to confirm the month and you will hear the meter report the day of the month. Press the "Up" or "Down" buttons until you hear the desired day.
Press the "Set" button to confirm the day and you will hear the meter report the hour. The meter works with a 12 hour system. Press the "Up" or "Down" buttons until you hear the desired hour.
Press the "Set" button to confirm the hour and you will hear the meter report the minutes. Press the "Up" or "Down" buttons until you hear the desired minutes.

Important Note: The blood glucose average over a period of days is calculated from the current date and time. This means that when the date and time are changed, the day's average result may change as well.

Press the "Set" button to confirm the minutes and you will hear the meter report the unit of measurement. Press the "Up" or "Down" buttons to select milligrams per deciliter (American system) or millimoles per liter (Canadian system).

Attention: If the Prodigy Voice Meter is purchased in Canada, the meter will measure in units of millimoles per liter only. The use of the incorrect unit of measurement may cause you to misinterpret your blood glucose results and may lead to incorrect treatment.

Press the "Set" button to confirm the unit of measurement and you will hear the meter report the speaking volume. Press the "Up" or "Down" buttons until you hear the desired speaking volume. Number 0 indicates that the speaking function is turned off. Numbers 1 to 7 indicate the speaking volume from low to high.

Press the "Set" button to confirm the volume level and the meter will say:
"Delete memory record function. Press the 'Up' key to clear all records."

You have two options for your memory records: OPTION 1:
If you do not want to delete the memory stored in the meter, press the "Set" button again to skip this step and complete the meter settings.

OPTION 2:
If you want to delete all the memory stored in the meter, press the "Up" button.
After pressing the "Up" button one time, the meter will say:
"Are you sure you want to clear all records? Press the 'Up' key again to clear all records."

Press the "Up" button one more time and the meter deletes all stored memory, then the meter will say:
"All memory records have been deleted."
The meter memory is now empty.

The meter settings are now completed. The meter will report all selections made in the setting mode and then will say:
"Have a nice day!"
play the ending music and automatically turn off.

Please Note: The speaking volume can be adjusted at many other times while the meter is on, simply by pressing the "Up" or "Down" buttons. For example, when testing your blood glucose, if you discover the speaker volume is too loud or too soft, simply press the "Up" or "Down" buttons to adjust the volume to a comfortable level. You do not need to be in setting mode to do this.

Section 13: How to Perform a Control Solution Test Page 16 and 17

Perform the control solution test by following these steps:

STEP 1. Insert a test strip into the meter and the welcome music will play. For correct test strip insertion, refer to "Section 7 - Orientation to the Prodigy Voice Meter".
"Thank you for using Prodigy Voice."
and you will hear a voice message
"Test strip inserted."
It means the test strip has been correctly inserted into the meter. The meter will then announce the current date and time. Next, the meter announces: "Please apply blood onto the test strip."
followed by a short beep.

STEP 2. Press the "M" button and you will hear:
"You are now in control solution mode."
Indicating you can now perform a control solution test.

Attention:
Before applying the drop of control solution to the test strip, please make sure that you have entered the control solution mode by pressing the "M" button. The test result under this mode will not be stored in the meter memory. Failure to do so will confuse the blood glucose test results with the control solution test result in the memory.

STEP 3. Shake the control solution bottle well, remove the cap and squeeze the bottle to obtain a drop of control solution. Discard the first drop, and wipe off the dispenser tip with a tissue paper or cotton to prevent contamination. Squeeze the bottle again to get a second drop and then place it on your fingertip or some other clean, non-absorbent surface e.g. palm of hand.

STEP 4. Move your fingertip with the drop of control solution towards the absorbent opening of the test strip. The test strip will draw in the control solution and then you will hear:
"Now testing",
you can move your finger away from the test strip. The meter is now testing.

STEP 5. After about six seconds, you will hear the meter report:
"Your blood glucose is (number displayed) milligrams per deciliter" or "millimoles per liter".
A control solution reading should be between the ranges printed on the test strips' vial label. If your control solution test result is out of range; please refer to "Section 20 - Problem Solving Tips and Solutions When Operating the System" for a possible solution to the problem.

If you decide not to perform a control solution test and want to exit the control solution mode, press the "M" button again and you will hear the meter say:
"You are now in testing mode."
It indicates that you have exited the control solution mode. At this point, you can choose to test your blood glucose or turn the meter off by removing the test strip.

Please do not directly apply control solution from the bottle into a test strip as it may contaminate the control solution with the chemical reagent from the test strip. Please place a drop of control solution on a clean surface or on your fingertip.

Section 14: Applying a Blood Sample to the Test Strip without Vision Page 18 and 19

Using the following five tips may help you to place a sample into the test strip successfully if you have low or no vision. The examples describe two ways to bring the sample and the test strip together. Other techniques may work just as well. Keep experimenting until you have a technique which works for you consistently.

Tip One - Smaller has its Advantages Because the Prodigy Voice Meter is so easy to move around, you can experiment with many different approaches to determine which works best for you. Get comfortable holding the meter in one hand while testing. The meter can be moved towards your finger as easily as your finger can be moved to the test strip.

Tip Two - Shoot for the Tip
The rounded tip of the test strip contains an opening to the absorbent channel in the center where the blood should be applied. The absorbent channel draws the blood into the test strip, much like a straw, when the tip touches the blood sample. Blood should be applied only on the very tip. Blood applied to the bottom or sides of the test strip may cause inaccurate readings. It is important that the test strip does not bend at all when applying the sample.

Tip Three - Using a Sideways Approach
When testing, it may be helpful to rest or hold the meter on one side rather than flat or face up. In this position, the test strip sticks out of one end and the side with the buttons faces towards you. The idea here is that the finger can be brought to the test strip from below until it touches the tip of the test strip. Then, the meter can be repositioned so the sample touches the absorbent opening at the end of the test strip. Notice how the meter can be positioned so that the test strip can be sticking out to the left or to the right. This allows for either hand to be used for testing.

Tip Four - Example 1
Step 1 - Place the meter on one side in front of you on a table with the test strip pointing to the left.
Step 2 - Gently squeeze a finger on the left hand and obtain a sample.
Step 3 - Bring your finger toward the tip of the test strip from the bottom. Place the puncture site on your finger to the tip of the test strip.
Step 4 - If you do not make contact with the blood and the meter does not begin the test, while keeping the finger in contact with the test strip, lift the rounded end of the meter from the table so the round end of the test strip is flush with the sample.
Step 5 - Move the test strip slightly, if necessary, until you hear the meter say "Now testing." Hold the meter in place until you hear the test result.

This procedure can be used with either hand by starting with the meter resting on the other side.

Tip Four: Example 2
Step 1 - Gently squeeze the finger to bring the blood to the finger.
Step 2 - Puncture the finger.
Step 3 - Hold the meter in your hand. Place your index finger under the test strip to help you guide the meter to where you have poked.
Step 4 - Using overlapping dragging motions in an upward direction, repeat the motion around the puncture sight until you hear the meter say, "Now testing."
Step 5 - Hold the test strip in place until you hear the meter say your test results.

Tip Five - Practice, Practice, Practice
As with all new skills, practicing is the key to feeling comfortable performing this new skill with confidence and ease. Don't give up; remember practice, practice, practice. We suggest using the Prodigy Control Solution when practicing. Practice until, with relative ease, you can get a test result that falls within the target range for the Prodigy Control Solution three tests in a row. It can be helpful to have someone with sight watch you practice to provide feedback or to answer any questions you have.

Section 15: Testing Your Blood Glucose Page 20, 21 and 22

Before you start to test your blood, please make sure you have all items needed to test. Items include a blood glucose meter, test strips, a lancing device, and a sterile lancet.

Never share a lancet or a lancing device with others and always use a new lancet for penetration.

Please Note: This system also provides Alternative Site Testing. If you want to test blood glucose from a site other than a fingertip, please refer to "Section 21 - About Alternative Site Testing" for details.

Please wash and dry your hands thoroughly before starting the testing procedure.

STEP 1. Prepare the lancing device for testing. Hold the center section of the lancing device in one hand while the other hand holds the cap of the lancing device. Screw the cap off until the two sections come apart. Inside the middle of the longer section of the lancing device is a plastic lancet holder. Insert a lancet into the lancet holder and push down firmly until it is fully seated. Then, twist the protective cap on the lancet until it separates from the lancet. Finally, replace the lancing device cap by screwing it back on the lancing device.

Hold the lancing device by the middle section with the two indentations between your thumb and forefinger, twist the adjustable tip in either direction until the desired depth setting is reached. The setting Numbers 1 and 2 are for soft or thin skin, Number 3 is for average skin, Numbers 4 and 5 are for thick or callused skin.

Hold the adjustable tip in one hand and pull the ejection/cocking control which is the upper half of the lancing device, back with the other hand until you hear a click. If it does not click, the device may have been cocked when the lancet was inserted. The lancing device is now ready for use. Set the lancing device aside and proceed to the next steps for blood glucose testing.

STEP 2. Insert a test strip into the meter. For directions on correct test strip insertion, please refer to "Section 7 - Orientation to the Prodigy Voice Test Strips". The meter will play the welcome music and then say:
"Thank you for using Prodigy Voice."
A voice message will be heard saying,
"Test strip inserted."
It means the test strip has been correctly inserted into the meter. Next, the meter reports the date and time. The meter then says:
"Please apply blood onto the test strip."
followed by a short beep. The meter is now ready to test.

STEP 3. Hold the lancing device firmly against the side of your finger. Press the "Release" button. You will hear a click, indicating that the lancet has been released and the skin should be punctured. We suggest discarding the first drop of blood with a clean tissue paper or cotton as the first drop may contain tissue fluid and serum and may affect the test result.

Please use the second drop of blood for testing. You may gently squeeze the punctured area to obtain blood, but please be careful that you do not squeeze too hard to prevent getting a smeared sample.

STEP 4. Move your finger with the drop of blood on it towards the absorbent opening of the test strip. After you hear:
"Now testing",
you may move your finger away from the test strip. It means that the meter has begun the process of blood glucose testing.

If you do not hear,
"Now testing",
your blood may be on the sides of the test strip instead of in the absorbent opening of the test strip or there may not be enough blood. Please do not try to re-apply blood to the test strip. Please discard the test strip and use a new test strip to restart the test procedure.

STEP 5. After about six seconds, you will hear a voice message saying:
"Your blood glucose is"
and a number will be heard in either: "milligrams per deciliter" or "millimoles per liter".
This reading is automatically stored in the meter's memory. To learn how to interpret the glucose reading, please refer to "Section 16 - How to Read Your Blood Glucose Test Results". Remember, if you do not hear the test result clearly, simply press the "Repeat" button to hear the result spoken again.

STEP 6. After you finish the test, you can either take out the used test strip by simply pushing up the Strip-Eject button on the top left hand side panel or by removing the test strip directly with your fingers. Please Note: The springs are very strong on the ejector switch, so make sure the test strip is pointed into a disposal container. After removing the used test strip, the ending music plays and the meter says:
"Have a nice day!"
and then the meter turns off.

STEP 7. Carefully remove the lancet from the lancing device. Discard the used lancet and the used test strip according to your local regulations.

Attention: The following is important information to remember when testing your blood glucose.

1. Please choose a different spot each time you test. Repeated punctures in the same spot may cause soreness, calluses or bruising.

2. You can press the "M" button at any time to skip the current voice message and go to the next step. This can be especially helpful when testing frequently or when in a hurry. For example, after placing the test strip into the meter to begin the test, when the music begins to play, press the "M" button. The music will immediately stop and the message, "Thank you for using Prodigy Voice.", will start speaking. If you then immediately press the "M" button again, this message will immediately stop and the next message will start. To quickly skip past the opening music and messages, you may press the "M" button repeatedly when the music begins until you hear the short beep. The meter is now ready for the sample to be applied.

3. If you want to hear the previous voice message, you can press the "Repeat" button to replay the message.

4. If you do not apply a blood sample to the test strip within three minutes, the ending music will play and the meter will turn off. You must remove the test strip and re-insert it to start the test procedure.

5. If you have trouble applying enough blood into the test strip, please contact Technical Support at 1-800-243-2636 for help.

Section 16: How to Read Your Blood Glucose Test Results Page 23

In 2003, the American Diabetes Association recommended that the plasma glucose range for people without diabetes be less than 110 milligrams per deciliter or 6.1 millimoles per liter when fasting or before meals, and is less than 140 milligrams per deciliter or 7.7 millimoles per liter, two hours after a meal.

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

This system can test glucose from 20 milligrams per deciliter to 600 milligrams per deciliter or 1.1 millimoles per liter to 33.3 millimoles per liter.

If your test result is lower than 20 milligrams per deciliter or 1.1 millimoles per liter, you will hear the meter say:
"Your blood glucose is less than 20 milligrams per deciliter or 1.1 millimoles per liter."
This indicates severe hypoglycemia (extremely low blood glucose levels in the blood stream). Make sure the absorbent channel of the test strip is full of blood; if not, please re-test. Severe hypoglycemia is a true emergency. Immediately seek emergency help to raise your blood glucose level.

If your blood glucose test result is above 600 milligrams per deciliter or 33.3 millimoles per liter you will hear the meter say:
"Your blood glucose is over 600 milligrams per deciliter or 33.3 millimoles per liter."
This indicates severe hyperglycemia (extremely high blood glucose levels in the blood stream). You should contact your healthcare professional immediately.

When your blood glucose test result is higher than 240 milligrams per deciliter or 13.3 millimoles per liter, this indicates high blood glucose levels and possible ketones; you should ask your healthcare professional for help.

If you want to compare your blood glucose results to the laboratory results, please note the following information. The lab result used in the comparison should be the blood glucose level, not the A1C result. Meter results and lab results are measured in equivalent plasma units and can vary due to normal variations. Circumstances that can affect the meter results can be different from what affects the lab results.

To get an accurate test result, perform a control solution test before taking the meter to the lab to ensure the meter is working properly. Best test results can be obtained by fasting at least 8 hours before doing the lab and meter comparison. While at the lab, make sure the lab test and meter test are done within 15 minutes of each other. Wash your hands and always use your fingertips for the comparison test. Do not use any blood from a gray topped laboratory test tube. Remember, you may still have variations in test results because blood glucose levels can change very quickly due to stress, eating a meal or snack, exercising, or taking medication. In addition, if you have eaten recently, your blood glucose can be 70 milligrams per deciliter or 3.9 millimoles per liter higher than a sample drawn from the lab.

Other factors which can affect your test results are the amount of red blood cells in the blood, a high or low hematocrit, or loss of body fluids such as severe dehydration. Please consult your healthcare professional or contact Technical Support at 1-800-243-2636 if you have any further questions.

Section 17: Reviewing the Historical Results from the Meter Memory Page 24

Your meter stores the 450 most recent blood glucose test results with the date and time in its memory. It also provides you with 7, 14, 21, 28, 60 and 90 day averages of your blood glucose test results. You can review each test result or review the average of blood glucose results from the meter by using the following steps.

When the meter is off, press the "M" button to enter the memory mode. The welcome music plays and the meter says,
"Thank you for using Prodigy Voice."
The meter reports the current date and time, and then says
"Press the 'M' key for memory recall mode."
This message indicates that you are in the memory mode and you now have two choices. You can choose to either review individual test results or choose to review blood glucose reading averages. To review individual test results, press the "M" button again and you will hear the meter report the most recent reading first. If you want to review average test results instead, rather than just pressing and releasing the "M" button, press and hold down the "M" button for 2 or 3 seconds and release the "M" button. You will then hear the meter report the 7 day average result first. To hear other readings or other average test results, use the "Up" or "Down" buttons.

Any time you want to exit the memory mode, hold down the "M" button for five seconds or leave the meter alone without any action for three minutes. The meter will turn off automatically.

When you review the historical results, please note the following:
1. The control solution results are NOT stored in the memory. The list of past individual test results and the average test results are for blood glucose results only.

2. When using the meter for the first time, you will hear a voice message saying
"No Memory Record available",
indicating that there is no test result in the memory. The meter will turn off automatically.

3. You can press the "M" button at any time to skip the current voice message and go to the next step.

4. If you want to hear the previous voice message, you can press the "Repeat" button to replay the message.

5. If you do not press a button within three minutes, the ending music plays and then the meter will turn off automatically.

Section 18: Transmitting Historical Results to Your Computer Page 25

Test results in memory can be transmitted to your computer. The personal Interface Cable is an optional accessory but it is required before the download of results can take place. The software can be downloaded from www.prodigymeter.com. To learn more about the Diabetes Management System Software or to purchase an Interface Cable which is sold separately, please contact your local retailer or distributor. You can transmit the results using the following steps:

STEP 1. Install the Diabetes Management System Software on your computer by following the instructions provided on Prodigy's website: www.prodigymeter.com.

STEP 2. Connect the Interface Cable to the data port of your computer. While the meter is turned off, connect the Interface Cable to the data port of the meter which is hidden under the rubber cover on the curved bottom side panel. You will hear a voice message say,
"Connecting to your computer",
Indicating that the meter is ready to transmit the data.

STEP 3. Transmit the Data. Follow the instructions provided by the software to transmit the data. Test results transmitted will include the date and time. Remove the Interface Cable and the meter will automatically turn off.

Please Note: While the meter is connected to the computer, it is unable to perform a blood glucose test.

Section 19: How Does the Meter Report the Error Messages Page 26

The Error Messages you will probably encounter will be announced and will also appear on the display when you use this meter. If you have any problems performing a test with this meter, please refer to the following guides.

When you hear a voice message saying,
"Battery is dead, please replace."
It indicates that you must change the batteries immediately.

When you hear a voice message saying,
"The room temperature is out of range; Thus unable to measure."
It indicates that the ambient temperature is out of the system operation range. Please go to a site where the room temperature is between 50°Fahrenheit to 104°Fahrenheit or 10°Celsius to 40°Celsius; stay in the room for a while and then repeat the test.

When you hear a voice message saying,
"Please ensure proper operation and try again."
It indicates that the test strip was removed before the meter was finished testing your blood glucose. Please remove the test strip, discard it and use a new test strip to repeat the test.

When you hear a voice message saying,
"Strip has been used. Please replace."
It indicates that you inserted a used test strip. Please use a new test strip to repeat the test.

When you hear a voice message saying,
"Meter malfunction, please contact local distributor."
It indicates that there is a problem with the meter that you cannot solve by yourself. Please contact your local distributor or contact Technical Support at 1-800-243-2636 for help.

If you encounter any error messages not being announced or if you have followed the actions recommended but the problem persists, please contact Technical Support at 1-800-243-2636 for help.

Please Note: All of the unread error messages can be found in the printed manual.

Section 20: Problem Solving Tips and Solutions When Operating the Prodigy Voice System Page 27

This section is intended to provide solutions if you have problems while operating the meter. If the problem you encounter is not included in this section or if you have followed the actions recommended but the problem persists, please contact Technical Support at 1-800-243-2636 for help.

Condition 1: If the meter did not work after inserting a test strip, what should I do?

First, remove the test strip and press the "Repeat" button. The meter should speak the current date and time. When done, try re-inserting the test strip ensuring that it is pressed firmly against the bottom, or floor, of the test slot while sliding the test strip in. If that does not work, check the batteries. If you replace the batteries, please check if the batteries are correctly installed. If you have used the meter for a period of time without changing the batteries, please use new batteries. For battery replacement, please refer to "Section 11 - How To Change the Batteries" for instructions.

Secondly, please check if the test strip is inserted correctly. Please refer to "Section 7 - Orientation to the Prodigy Voice Test Strips" for more information.

If you have followed the previous actions but the problem persists, please contact Technical Support at 1-800-243-2636 for help.

Condition 2: If the meter did not give a reading after applying the sample, what should I do?

It may be because of an insufficient blood sample applied on the test strip, blood on the sides instead of in the tip of the test strip or the test strip is defective. Please remove the used test strip from the meter and repeat the test. To get a drop of blood correctly, please refer to "Section 14 - Applying a Blood Sample to the Test Strip without Vision" and "Section 15 - Testing Your Blood Glucose".

If you have followed the previous actions but the problem persists, please contact Technical Support at 1-800-243-2636 for help.

Condition 3: If the control solution test result is out of range, what should I do?

First, please check that the control solution has not expired. Second, place the solution at room temperature for 10 minutes because a very warm or a very cold control solution may cause an incorrect test result. Third, shake the control solution vigorously before getting a drop. Then follow the directions in "Section 13 - How to Perform a Control Solution Test" and repeat a control solution test. If none of the above suggestions work, try replacing the batteries and repeat a control solution test

If you have followed the previous actions but the problem persists, please contact Technical Support at 1-800-243-2636 for help.

Section 21: About Alternative Site Testing (AST) Page 28

Please consult your healthcare professional before you perform Alternative Site Testing or AST. You may need assistance when you obtain blood samples.

Alternative Site Testing means that people are able to use parts of the body other than fingertips to check their blood glucose levels. The Prodigy Voice Meter is able to test on other body sites including the palm, the forearm, the upper arm, the calf, and the thigh. Test results from other body sites are equivalent to the test results from a fingertip when you are in a relaxed, calm state.

We strongly recommend you do Alternative Site Testing ONLY at the following times: in a pre-meal or fasting state, more than 2 hours after the last meal, 2 hours or more after taking insulin, and two hours or more after exercising.

If you want to test your blood glucose during or immediately after a meal, after physical exercise, or after any other event, please take the blood sample from your fingertip only.

Please Note: Do NOT perform Alternative Site Testing if you think you are experiencing hypoglycemia, if your Alternative Site Testing test results do not match the way you feel, if you are testing for hyperglycemia, if your routine glucose test results are often fluctuating, or if you are pregnant.

To get enough of a blood sample from the palm, the forearm, the upper arm, the calf and the thigh, please rub the puncture site for 20 seconds before puncturing your skin and use the clear cap instead when setting the lancing device.

This concludes the Prodigy Voice Manual.
Again, thank you for using our Prodigy Products.
This manual has been produced and edited by Diagnostic Devices, Inc., in cooperation with the National Federation of the Blind.

Version 0608.02
Copyright 2008 Diagnostic Devices, Inc., All rights reserved.
Charlotte, North Carolina. USA
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Created on ... July 17, 2008