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 steadystate blood glucose conditions described in the “About AST” section.
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.
Start with the meter off. Then press and hold the
set button. The meter is now in the setting mode.
You can start setting 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: “Youarenowinsetting mode.Theyear is2007.”
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: “The month is November”
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: “The 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: “The 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: “The minute is 08.”
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: “Temperture 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.”
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.
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.
- 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 (6877º F/2025º 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.
• 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:
“CHK”and“ ” “ ” “ ” andflashing“ ”
Voice SPEAKS: “Thank you for using Prodigy Voice.” Test Strip inserted. Today’s date is (Today’s date; Example: November 18th, 2007). The time is (The 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.”
STEP 2 Press the button
While the “ ” symbol appears on the display, press the “M” button and then “CTL” will appear on the display. With the “CTL” symbol on the display, the meter will not store your test result in memory.
Voice SPEAKS: “You are now in control solution mode.”
If you decide not to perform a control solution test, press
the “M” button again, and the “CTL” symbol will disappear, you are now in the testing mode.
Voice SPEAKS: “You are now in testing mode.”
At this point you may test your blood glucose or turn the meter off by removing the test strip.
WARNING
- Contact bars must be inserted all the way into the meter or you may get an inaccurate test result.
- Every time you perform a control solution test, you must enter into the “CTL” test mode so that the test result will not be stored in the meter memory. Failure to do so will confuse the blood glucose test result with the control solution test result in memory.
STEP 3 Apply Control Solution
Shake the control solution bottle well. Remove the cap. Squeeze the bottle, discard the first drop and wipe off the dispenser tip with a clean tissue paper or cotton swab. Squeeze a drop on a clean nonabsorbent surface or on your finger tip first. Then, apply the drop to the test strip absorbent channel, (where it meets the narow channel) until the drop is drawn into the test strip and the confirmation window is filled. The meter begins to count down.
Voice SPEAKS: “Now testing.”
CAUTION: To avoid contaminating the control solution with the content of the test strip, you have to place a drop of control solution on a clean surface or on your clean finger tip first, then touch the strip to the drop.
DO NOT APPLY THE CONTROL SOLUTION
Correct Incorrect
DIRECTLY TO THE TEST STRIP!
STEP 4 Read and Compare the Result
After counting from 6 to 0, the test result of control solution is shown on the screen. Compare this result with the range printed on the test strip vial. It should fall within this range.
Low
60 -96
Voice SPEAKS: “Your blood glucose is sevemty two
milligrams per deciliter.”
Outofrange results
If test results fall outside the range printed on the test strip vial, check the section of “Problem in Operation” section in troubleshooting guide and repeat the test. If you continue to get outofrange results, it means that the system may not be working properly. Do NOT test your blood glucose. If you are unable to resolve the problem, contact the Technical Support line at 8002432636.
TESTING YOUR BLOOD
Be sure to read this section and the test strip package insert found in the test strip box carefully before testing. Make sure you have all items needed to test:
A. Blood Glucose Meter
B. Test Strip
C. Lancing Device
D. Sterile Lancet
E. Clear Cap (For AST use) C
AB DE
WARNING
To reduce the chance of infection:
- Never share a lancet or the lancet device with anyone.
- Always use a new, sterile lancet. Lancets are for single use only.
- Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the lancing device.
• Testing Procedure
The lancing device is now ready for use. Set it aside for later use.
STEP 2 Insert 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:
“CHK”and“ ” “ ”
“ ”, and flashing “ ”
Voice SPEAKS: “Thank you for using Prodigy Voice. Test Strip Inserted. Today’s date is (today’s date). The time is (the time). Prodigy Voice works only with the Prodigy Voice test strips. Please apply blood into the test strip.”
STEP 3 Get a Drop of Blood
Select the puncture site either in fingertip or in other parts (AST). Wash your hands and the puncture site. Use warm, soapy water. Rinse and dry thoroughly.
• Fingertip
Hold the lancing device firmly against the side of your finger. Press the release button. You wia click, indicating that the puncture is complete.
• Gently Massage the Area
Do not smear the blood sample. To obtain best accurate Correct results, the first drop of blood should be discarded with a clean tissue paper or cotton. Use the second drop of blood for testing. The required blood sample in 0.6 microliter in volume.
WARNING: The first drop of blood usually contains tissue
fluid and serum, which may affect the result. It should be
Incorrect
discarded.
• Sites other than fingertip
Please refer to the of “About AST” section for available testing sites. Please consult your health care professional before obtaining blood from sites other than your fingertips.
WARNING: The system requires a very small blood drop to perform a test. You can obtain it from a fingertip. Choose a different spot each time you test. Repeated punctures in the same spot may cause soreness and calluses.
Before you decide to do palm testing, please consult your health care professional.
STEP 4 Apply Blood into the Test Strip
When “ ” is flashing on the screen, apply your blood to the absorbent channel of the test strip until the confirmation window is fully covered with blood. The meter then begins to count down automatically.
Voice SPEAKS: “Now Testing.”
STEP 5 Obtain an Accurate Result in 6 Seconds
The result of your blood glucose test is shown after the meter counts from 6 to 0. This reading is automatically stored in the meter.
Voice SPEAKS: “Your blood glucose is ninetytwo milligrams per deciliter.”
Correct
Incorrect
PLEASE NOTE
- Do not push your finger (with blood on it) against the test strip or try to apply a smeared sample on the test strip.
- If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and reinsert the test strip to restart the test procedure.
- Anytime you can press the “M” button to skip the current voice message and go to the next step.
- If you want to hear the previous voice message, you can press the “Repeat” button to replay it.
- The blood should be completely fill the confirmation window before the meter begins to count down. If you find that the confirmation window is not filled with blood when the meter is counting, NEVER try to add more blood to the test strip. Discard the test strip and retest with a new one.
- If you have trouble filling the test strip, please contact the Technical Support for help.
STEP 6 Eject the Used Test Strip
After finishing the measurement, you can either take out the used strip by simply pushing up the StripEject button or remove the test strip directly with your hand. “OFF” is shown after the used strip is ejected and the meter will shut off automatically afterward.
Voice SPEAKS: “Have a nice day.”
PLEASE NOTE
Please make sure the eject button is pointed into a disposal container.
• Expected Test Results
Blood glucose monitoring plays an important role in diabetes control. A longterm study showed that keeping blood glucose levels close to normal can reduce the risk of diabetes complications by up to 60%*3. The results you get with the PRODIGY Voice system can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes.
| Time of day | Plasma glucose range | Your target range |
| (mg/dL) for people | (mg/dL) |
| without diabetes | |
Fasting and before meal Less than 110
2 hours after meals Less than 140
Bedtime Not specified
Between 2 AM and 4AM Not specified
Source: ADA Clinical Practice Recommendations 2003
Please work with your doctor to determine a target range that works best for you.
*3: American Diabetes Association position statement on the Diabetes Control and Complications Trial (1993).
COMPARING METER AND LABORATORY RESULTS
The result you obtain from your meter may differ somewhat from your laboratory result due to normal variation. Meter results can be affected by factors and conditions that do not affect laboratory results in the same way (See test strip package insert for typical accuracy and precision data, and for important information on limitations). To make an accurate comparison between meter and laboratory results, follow the guidelines below.
Before you go to the lab:
- Perform a control solution test to make sure that the meter is working properly.
- It is best to fast for at least eight (8) hours before doing comparison tests.
- Take your meter with you to the lab.
While at the lab:
Make sure that the samples for both tests (the meter test and the lab test are taken and tested within 15 minutes of each other).
- Wash your hands before obtaining a blood sample.
- Never use your meter with blood that has been collected in a graytop test tube.
- Use fresh capillary blood only.
You may still have a variation from the result because blood glucose levels can change significantly over short periods of time, especially if you have recently eaten, exercised, taken medication, or experienced stress*4. In addition, if you have eaten recently, the blood glucose level from a finger stick can be up to 70 mg/dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for a lab test*5. Therefore, it is best to fast for eight hours before doing comparison tests. Factors such as the amount of red blood cells in the blood (a high or low hematocrit) or the loss of body fluid (severe dehydration) may also cause a meter result to be different from a laboratory result.
References
*4: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 4951.
*5: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Textbook of Clinical Chemistry. Philadelphia:
W.B. Saunders Company (1994), 959.
USING THE METER MEMORY
• View Results on the Meter
The Prodigy® Voice stores the 450 most recent blood glucose test results with 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 the test results in memory with these easy steps.
1. Recall the Stored Test Results
STEP 1. When the meter is off, press and release the M button. The screen shows “
”. Press the M button again, “1” appears first and then the latest glucose result along with date and time will be shown on the screen.
Voice SPEAKS: “Thank you for using Prodigy Voice. Today’s date is (today’s date). The time is (the time). Press “M” key for memory recall mode.”
STEP 2. Press the “Up” and “Down” button to recall the test results stored in the meter.
Voice SPEAKS: “Memory RecordforAugust23rd,2007.8:36AM.Your blood glucose was 80 milligrams per deciliter.”
STEP 3. Exit the memory mode, press and hold down the “M” button and the meter will be turned off.
Voice SPEAKS: “Have a nice day.”
NOTE
If you leave the meter alone without any action for 3 minutes, the meter will turn off automatically.
2. Read the Average of Blood Glucose Results
STEP 1. When the meter is off, press and release the M button. The screen shows “
”. Keep pressing the “M” button for 23 seconds, until blinking “
” appears. Release the “M” button and then the 7day average result will appear on the screen.
Voice SPEAKS: “Thank you for using Prodigy Voice. Today’s date is (today’sdate).Thetimeis (thetime). Press “M” key for memory recall mode.”
STEP 2. Press the “Up” and “Down” buttons to review the 14, 21, 28, 60 and 90 day average. Like the 7day average, the 14day average and the times of performing test in the past 14 days will be shown on the screen.
Voice SPEAKS: “The fourteen day average is eightythree milligrams per deciliter for eightyseven records.”
STEP 3. Exit the memory mode, press and hold down the “M” button, and the meter will turn off.
Voice SPEAKS: “Have a nice day.”
NOTE
- The control solution results are NOT stored in the memory (please turn to page 2223 for WARNING information). The list of past results and the result average are for blood glucose results only.
- When using the meter for the first time, “—” is displayed when you recall the test results or review the average result. It means that there is no test result in memory.
Voice SPEAKS: “No memory record available.”
• Any time you want to exit the memory mode, keep pressing the M button for 5 seconds or leave it without any action for 3 minutes. The meter will turn off automatically.
• Viewing Results on a Personal Computer
Results in memory can be transmitted to a personal computer. Prodigy Diabetes Management Software and an Interface Cable are required before installation. The software can be downloaded from www.prodigymeter.com. The interface cable is an optional accessory. To learn more about Prodigy Diabetes Management Software or to obtain an Interface Cable sold separately, please contact your local retailer or distributor.
STEP 1 Install Software
Install Prodigy Diabetes Management Software on your Computer by following the instructions provided on Prodigy’s website: www.prodigymeter.com
STEP 2 Connect to Personal Computer
Connect the Interface Cable to your computer. With the meter turned off, connect the Interface Cable to the Data Port of the meter. Which is hidden by a plastic cover on the bottom right side panel of the meter. “PC” will appear on the display, indicating that the meter is ready to transmit data.
STEP 3 Transmit Data
Follow the instructions provided in the software to transmit data. Results transmitted will include date and time. Remove the cable and the meter will automatically turn off.
PLEASE NOTE
While the meter is connected to the PC, it is unable to perform a blood glucose test.
CARING FOR YOUR METER AND TEST STRIPS
To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
• Cleaning
Your meter does not require special maintenance. As long as no blood or control solution comes in direct contact with the meter, there is no special cleaning required.
- To clean the meter exterior, wipe with a cloth moistened with tap water or a mild cleaning agent, then dry the device with a soft and dry cloth. Do not flush with water.
- Do not use organic solvents to clean the meter.
Your meter is a precision instrument. Please handle it with care.
• Storage
1. Meter Storage
- Storage condition: 4ºF~140ºF (20ºC~60ºC), below 95% relative humidity.
- Always store or transport the meter in its original storage case.
- Avoid dropping and strong impact.
- Avoid direct sunlight and humidity.
2. Strip Storage
- Storage condition: 39.2ºF~104ºF (4ºC~40ºC), below 85% relative humidity. Do not refrigerate.
- Store your test strips in their original vial only. Do not transfer to other container.
- Store test strip packages in a cool and dry place. Keep away from direct sunlight and heat.
- After removing a test strip from the vial, immediately replace the vial cap and close it tightly.
- Touch the test strip with clean and dry hands.
- You may touch the test strip anywhere with clean, dry hands when removing it from the vial or inserting it into the meter.
- Use each test strip immediately after removing it from the vial.
- Write the discard date (the date opened plus 90 days) on the vial label when you first open it. Discard remaining test strips 90 days after first opening date.
- Do not bend, cut, or alter a test strip in any way.
- Keep the strip vial away from children since the cap and the test strip can be a potential choking hazard. If swallowed, please seek medical assitance immediately.
3. Control solution storage
- Storage condition: Store the control solution tightly closed at temperatures below 86ºF (30ºC). Do not refrigerate.
- Record the discard date (date opened plus 90 days) on the control solution vial. Discard after 90 days.
PROBLEMSOLVING GUIDE
The following is a summary of some display messages and symbols. These messages help
to identify certain problems but do not appear in all cases when a problem has occurred.
Improper use may cause an inaccurate result without producing an error message.
In the event of a problem, refer to the information under “action”.
Never try to disassemble the meter in any circumstances. If you encounter any error messages not listed below or if you have followed the actions recommended but the problem remains unsolved, please call the Technical Support 18002432636.
- Special Message
- Error Message
- Problem in Operation
| MESSAGE | WHAT IT MEANS | ACTION |
|---|
 | Appears when your result is below measurement limit, which is less than 20 mg/dL. (1.1 mmol/L) | This indicates hypoglycemia (low blood glucose.) You should immediately treat hypoglycemia as recommended by your healthcare professional. |
 | Appears when your result is above measurement limit, which is higher than 600 mg/dL. (33.3 mmol/L) | This indicates severe hyperglycemia (high blood glucose). Please seek medical assistance immediately. |
 | KETONE? appears when your | This indicates there is a |
 | result is equal or higher than | possibility of ketone accumulation |
 | 240 mg/dL. (13.3 mmol/L) | if you have Type 1 diabetes. Please seek medical assistance immediately. |
| MESSAGE | WHAT DOES METER SAY? | WHAT IT MEANS | ACTION |
|---|
 | Battery is dead. Please replace. | Appears when the batteries cannot provide enough power for a test. | Replace the batteries immediately. |
|---|
 | Strip has been used. Please replace. | Appears when inserting a used test strip. | Test with a new test strip. |
|---|
 | The room temperature is out of range. Thus unable to measure. | Appears when ambient temperature is below system operation range. 50º F (10º C) | System operation range is 50ºF~104ºF (10ºC~40ºC). Repeat the test after the meter and test strip have reached the above temperature. |
|---|
| Appears when ambient temperature is above system operation range. 104º F (40º C) |
| MESSAGE | WHAT DOES METER SAY? | WHAT IT MEANS | ACTION |
|---|
 | Please ensure proper operation then try again. | Remove the strip after applying blood to the absorbent channel. | Re-test with a new test strip. |
 | Please remove strip. | Test strip is inserted after the meter turns off. | Remove the test strip. |
 | Meter malfunction. Please contact local distributor. | Problem with the meter. | Review the instructions and re-test with a new test strip. If the above steps do not work, please contact technical support for help. |
- If the meter does not display a message after inserting a test strip:
- If the test does not start after applying the sample:
- If the control solution test result is out of range.
| PROBABLE CAUSE | WHAT TO DO |
| Battery exhausted. | Replace the batteries. |
| Battery incorrectly installed or absent. Test strip inserted upside down, incompletely or incorrectly. | Check that the battery is correctly installed. Insert the test strip correctly with the contact bars end first and facing up. |
| Defective meter. | Please contact Technical Support for help. |
| PROBABLE CAUSE | WHAT TO DO |
| Insufficient blood sample. | Repeat the test using a new test strip with larger volume of blood sample. |
| Defective test strip. | Repeat the test with a new test strip. |
| Sample applied after automatically shut off (3 minutes after last user action). | Repeat the test with a new test strip. Apply sample only when flashing blood symbol appears on the display. |
| Defective meter. | Please contact Technical Support for help. |
| POSSIBLE CAUSE | WHAT TO DO |
| Error in performing the test. | Read the instruction thoroughly and repeat the test again. |
| Did not shake the control solution bottle very well. | Shake the control solution vigorously and repeat the test again. |
| Expired or contaminated control solution. | Check the expiration date or the discarded date of the control solution. |
| Control solution that is too warm or too cold. | Control solution, meter, and test strips should come to room temperature (6877ºF /2025ºC) before testing. |
| Test strip deterioration. | Repeat the test with a new test strip. |
| Meter malfunction. | Please contact Technical Support for help. |
SPECIFICATIONS
Model No.: 51900
Dimension & Weight: 3.74”(L) x 2.17”(W) x 0.71(H) 2.6 oz.
95mm(L) x 55mm(W) x 18mm(H), 75 g
Power Source: two(2) 1.5V AAA alkaline batteries
Display: LCD
Memory: 450 measurement results with date and time
External output: RS232 PC interface
Auto electrode inserting detection
Auto sample loading detection
Auto reaction time countdown
Auto turnoff after 3 minutes without action
Temperature Warning
Operating Condition: 50ºF~104ºF (10ºC~40ºC), below 85% R.H. (noncondensing)
Storage/Transportation Condition: 39.2ºF~104ºF (4ºF~40ºF), below 85% R.H.
Measurement Units: either mg/dL or mmol/L
Measurement Range: 20~600mg/dL (1.1~33.3mmol/L)
The specifications may be changed without prior notice.
The device has been certified to meet the electrical and safety requirements of:
IEC 606011, EN 606011, IEC 610101, EN 610101, EN 610102101, EN 6060112, EN 61326.
symbol appears together with other display messages: the meter is functional and the result remains accurate, but it is time to change the batteries. 
symbol appears with the “Eb” 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). 
