Owner's Manual - Prodigy Diabetes Care

Owner's Manual - Prodigy Diabetes Care

Owner’s Manual PCM262 Rev.4 01/12 PRODIGY® Blood Glucose Meters Owner’s Manual Dear Prodigy® Meter Owner: Thank you for choosing the Prodigy® met...

7MB Sizes 0 Downloads 11 Views

Owner’s Manual PCM262 Rev.4 01/12

PRODIGY® Blood Glucose Meters

Owner’s Manual

Dear Prodigy® Meter Owner: Thank you for choosing the Prodigy® meter as your blood glucose monitoring system. Please read this manual carefully as it contains important information about your new Prodigy® system. A warranty registration card is included with your system. Please return the completed card to us or complete warranty online at www.prodigymeter.com. Prodigy® meters are designed to help you and your healthcare professionals monitor your blood glucose levels. This owner’s manual will help you learn how to use your Prodigy® meter effectively. Customer Care is available 24 hours, 7 days a week by calling toll free 1.800.243.2636. All questions concerning test results should be directed to your healthcare professional. Prodigy® meters have the latest technology for blood glucose monitoring and are made with quality components. All Prodigy® meters are easy to use, give you fast, accurate test results with a minimal sample of blood, have large, easy-to-read display screens, lightweight and portable for your convenience. Prodigy® meters: • Require No Coding, allowing you to save time and avoid human error due to improper coding. • Allow you to perform Alternate Site Testing (AST). • Have memory and data management capabilities. Prodigy® meter’s free software gives you and your healthcare professionals powerful graphic tools to manage your diabetes.

Prodigy Diabetes Care, LLC

1.800.243.2636 1

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Table of Contents Important Safety Instructions................................................................ 5 Important Health-Related Information.................................................. 7 Alternate Site Testing (AST).................................................................... 8 About Prodigy® Test Strips.................................................................... 10 Key Functions of the Test Strip............................................................ 10 Important Test Strip Information......................................................... 11 Control Solution Testing....................................................................... 12 About Prodigy® Control Solution.......................................................... 12 Important Control Solution Test Information...................................... 13 Performing a Control Solution Test .................................................... 14 Preparing the Lancing Device.............................................................. 18 Getting a Blood Sample........................................................................... 19 Introduction to Prodigy® Meters.......................................................... 21 Intended Use......................................................................................... 21 Test Principle......................................................................................... 21 The Prodigy AutoCode® Meter.................................................22 Contents of the Prodigy AutoCode® Meter..................................... 23 Setting up the Prodigy AutoCode® Meter....................................... 24 Key Functions of the Meter............................................................. 24 Meter Display ................................................................................... 25 Speaking Function........................................................................... 26 Setup Steps...................................................................................... 27 Performing a Blood Glucose Test.................................................... 31 Using the Meter Memory.................................................................. 33 Specifications.................................................................................... 35

Prodigy Diabetes Care, LLC

www.prodigymeter.com 2

The Prodigy Pocket® Meter.....................................................36 Contents of the Prodigy Pocket® Meter.............................................. 37 Setting up the Prodigy Pocket® Meter............................................ 38 Key Functions of the Meter...................................................................... 38 Meter Display ........................................................................................... 39 Setup Steps...................................................................................... 40 Performing a Blood Glucose Test.................................................... 44 Using the Meter Memory...................................................................... 46 Specifications........................................................................................ 48 The Prodigy Voice® Meter........................................................50 Contents of the Prodigy Voice® Meter................................................. 51 Setting up the Prodigy Voice® Meter............................................... 52 Key Functions of the Meter............................................................. 52 Meter Display ................................................................................... 53 Speaking Function........................................................................... 54 Setup Steps...................................................................................... 55 Performing a Blood Glucose Test......................................................... 60 Tips for Applying Blood to Test Strips without Sight.......................76 Performing a Blood Glucose Test.................................................... 79 Using the Meter Memory.................................................................. 66 Specifications........................................................................................ 68

Prodigy Diabetes Care, LLC

1.800.243.2636 3

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Important Safety Instructions Viewing Results on a Personal Computer........................................... 69 Caring for your Prodigy® Meter............................................................ 70 Cleaning your System........................................................................... 70 Disinfecting your System.......................................................................... 70 Storing your System...............................................................................71 Battery ...................................................................................................71 Low Battery............................................................................................71 Battery Replacement........................................................................... 72 System Troubleshooting....................................................................... 73 Special Messages................................................................................. 73 Error Messages..........................................................................................74 Troubleshooting Guide......................................................................... 75 Information About your Prodigy® Meter.............................................. 77 Comparing Meter and Laboratory Results.............................................. 77 Performance Characteristics................................................................... 78 Expected Test Results.............................................................................. 79 Unexpected Test Results...................................................................... 79 Accuracy of Meter Measurements.......................................................... 81 Symbols Information................................................................................. 83 Warranty Information............................................................................ 84 Limited Lifetime Warranty.................................................................... 84

Read this before using your Prodigy® meter. The following basic safety precautions should always be taken. • Your Prodigy® meter, test strips, lancets and lancing device are for single patient use only. Do not share them with anyone, including other family members. Do not use on multiple patients. • Close supervision is necessary when the device is used by, on, or near children, handicapped persons or invalids. • Use the device only for the intended use described in this manual. • Do not use test strips and control solutions with your Prodigy® meter that are not supplied by Prodigy®. • Do not use the device if it is not working properly, or if it has suffered any damage. • Before using any product to test your blood glucose, read all instructions thoroughly and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional. • Keep the test strip vial away from children; the vial cap and the test strips can be a potential choking hazard. • Never chew or swallow a test strip. If this occurs, please seek medical assistance immediately. • All parts of this kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. • These devices are intended to be used for patient self-monitoring

Prodigy Diabetes Care, LLC

www.prodigymeter.com 4

Prodigy Diabetes Care, LLC

1.800.243.2636 5

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Important Health-Related Information and should not be used to collect blood from more than one person as this poses a risk of transmitting blood-borne pathogens such as Hepatitis B or HIV. For further information, please refer to: “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood-borne 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 Blood-borne Pathogens” (2010) http://cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html

Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration consult a healthcare professional immediately. Under normal blood concentrations and conditions, the following should not significantly affect results: • Elevated blood triglycerides • Reducing substances such as uric acid and ascorbic acid • Acetaminophen • Dopa • Methyldopa • L-dopa • Tolbutamide If you are experiencing symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this owner’s manual, call your healthcare professional. Test results below 60 mg/dL (3.3 mmol/L) indicate low blood glucose (hypoglycemia). Test results greater than 240 mg/dL (13.3 mmol/L) indicate high blood glucose (hyperglycemia). If your results are below 60 mg/dL or above 240 mg/dL, repeat the test, and if the results are still below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), consult your healthcare professional immediately.

DO NOT CHANGE YOUR TREATMENT BASED ON A SINGLE RESULT THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 6

Inaccurate results may occur in severely hypotensive individuals or patients in shock. Inaccurate results may occur for individuals experiencing a hyperglycemic-hyperosmolar state. Please refer to the test strip package insert for additional important information.

Prodigy Diabetes Care, LLC

1.800.243.2636 7

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Alternate Site Testing (AST) There are important limitations to Alternate Site Testing (AST). Please consult your healthcare professional before performing AST.

What is AST?

Alternate Site Testing (AST) means you can use parts of the body other than your fingertips to check your blood glucose levels. Prodigy® meters allow you to test on your palm, forearm, upper arm, calf or thigh. See Figure 1.

What is the Advantage?

Fingertips feel pain more readily because they are full of nerve endings (receptors). At other body sites, nerve endings are not so numerous and you will not feel as much pain as you will experience at the fingertip.

When to use AST?

Use AST only: v Two hours or more after your last meal. v Two hours or more after taking insulin. v Two hours or more after exercise. v During a relaxed and calm state. Do not use AST if: v You have reason to believe you have hypoglycemia or hyperglycemia. v Your routine glucose results are often fluctuating. v You are pregnant. *To increase accuracy when using AST, rub the puncture site before extracting blood.

Food, medication, illness, stress and exercise can affect blood glucose levels. Capillary blood at the fingertip reflects these changes faster than capillary blood at other sites. Therefore, if you are testing your blood glucose level during or immediately after a meal, physical exercise or stressful event, take the blood sample from your fingertip only. Figure 1

Prodigy Diabetes Care, LLC

www.prodigymeter.com 8

Prodigy Diabetes Care, LLC

1.800.243.2636 9

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

About Prodigy® Test Strips Key Functions of the Test Strip

All Prodigy® meters measure the amount of sugar in the blood, commonly referred to as blood glucose. Blood is applied to the opening of the absorbent channel of the test strip and is automatically drawn into the test strip.

Important Test Strip Information

• Store test strip packages in a cool, dry place between 39.2°F–104°F (4°C–40°C). Keep away from direct sunlight and heat. Do not refrigerate.

The test strip consists of the following parts:

• Store your test strips in their original vial only. Do not transfer them to a new vial or any other container.

Absorbent Channel Apply a drop of blood and it will be drawn in automatically.

• 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. • Do not clean the testing site with alcohol.

Confirmation Window Shows whether enough blood has been drawn into the test strip’s absorbent channel.

• Immediately use a test strip after removing it from the vial, replace the vial cap and close it tightly. • Only apply a blood sample or a control solution sample to the test strip’s absorbent channel. Applying other substances to the test strip’s absorbent channel will cause inaccurate results.

Test Strip Handle Hold this part to insert the test strip into the test strip port on the meter.

Contact Bars Insert this end of the test strip into the meter. Push it in firmly until it will not go any further.

• Record the discard date on the vial label when you first open it. Discard remaining test strips 90 days after the first opening date. • Do not use test strips beyond the expiration date printed on the package. Figure 2

Please refer to the “Performing a Blood Glucose Test” section for your meter for complete instructions. Prodigy Diabetes Care, LLC

www.prodigymeter.com 10

Warning: Keep the test strip vial away from children; the vial cap and the test strips can be a potential choking hazard. Never chew or swallow a test strip. If this occurs, please seek medical assistance immediately. Prodigy Diabetes Care, LLC

1.800.243.2636 11

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Control Solution Testing About Prodigy® Control Solution

Prodigy® control solution is a red liquid containing glucose that will react with test strips and produce a test result. Prodigy® meters can use high or low control solution. v First, check your contents to see if you have a high or low control solution kit. v Then, after completing a control solution test, compare test results with the correct range (high or low) located on the back of the test strip vial. Why Perform a Control Solution Test? • To ensure that your meter and test strips are working properly together. • To allow you to practice testing without using your own blood. It is recommended to do a control solution test: • Once a week (to ensure that you continue to have accurate test results). • When you begin using a new vial of test strips. • When test strips are exposed to extreme environmental conditions. • If you drop the meter. • When you change the battery.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 12

Important Control Solution Test Information

• Use only Prodigy® control solutions with Prodigy® meters. • Check the expiration date on the control solution bottle. Do not use if expired. • Control solution, meter and test strips should be at room temperature (68–77°F/20–25°C) before testing. • Use within a period of 90 days from the date that you first open the control solution. Record the discard date on the control solution bottle and discard after 90 days. • Store the control solution tightly closed at temperatures below 86°F (30°C). Do not refrigerate.



Important: The control solution ranges are located on the back of the Prodigy® test strip vial. They are not recommended target ranges for your blood glucose level.

Prodigy Diabetes Care, LLC

1.800.243.2636 13

PRODIGY® Blood Glucose Meters

Owner’s Manual

Performing a Control Solution Test Start with the meter off.

STEP 1: Wash your Hands Wash your hands with mild soap and water before performing any test. Be sure to dry them thoroughly. STEP 2: Insert Test Strip Insert a test strip with the contact bar end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically and beeps. STEP 3: Mark as a Control Solution Test After the “ ” symbol appears on display, press the “M” button and a “ ” symbol appears on the display. With the “ ” symbol on the display, the meter will not store your test result in the memory. If you decide not to perform a control solution test, press the “M” button again and the “ ” symbol will disappear. Important: Be sure that you are in control solution mode so that the test result will not be stored in the meter memory.

PRODIGY® Blood Glucose Meters

STEP 4: Apply Control Solution • Shake the control solution bottle well, then remove the cap. • Squeeze the bottle to discard the first drop and wipe off the dispenser tip with clean tissue paper or cotton. • Squeeze the bottle again to get a second drop onto a clean, non-absorbent surface or on your fingertip. See Figure 3. Figure 3 • Apply the drop to the opening of the absorbent channel of the test strip (where it meets the narrow channel) until the confirmation window is filled. See Figures 4 and 5. • The meter will beep and begin to count down. Caution: To avoid contaminating the control solution with the content of the test strip, DO NOT DIRECTLY APPLY CONTROL SOLUTION ONTO THE TEST STRIP.

Figure 4

Prodigy Diabetes Care, LLC

www.prodigymeter.com 14

Owner’s Manual

Figure 5

Prodigy Diabetes Care, LLC

1.800.243.2636 15

PRODIGY® Blood Glucose Meters

Owner’s Manual

STEP 5 : Check if the Test Result is in Range. After Seven (7) seconds, the control solution test result appears on the display. Compare the test result with the range printed on the test strip vial. Each vial of Prodigy® No Coding Test Strips may have a different control solution range. The result should fall within the printed range on the test strip vial. See Figure 6.

PRODIGY® Blood Glucose Meters

Owner’s Manual

Caution: Do not use test strips or control solution that have exceeded the discard date, are expired or have been damaged. Your results may be inaccurate.

Out of Range Results If the result is not within the printed Figure 6 range, the meter and/or test strips may not be working properly. Repeat the control solution test.

Contact Customer Care If your test strips have been damaged or if you continue to get out-ofrange results, it means that the system or the control solution may not be working properly. DO NOT use the system to test your blood glucose level. If you are unable to resolve the problem, contact Customer Care at 1.800.243.2636.

Out of range results may occur due to: • damaged or expired test strips • contaminated or expired control solution • a meter malfunction • not following the directions If test results continue to fall outside the range printed on the test strip vial, check “Troubleshooting Guide” located in the “System Troubleshooting” section. Expiration or Damage Prodigy® No Coding Test Strips and Control Solutions have expiration dates printed on their labels. When one of these is first opened, you must record the discard date (date opened plus three (3) months) in the space provided. Prodigy Diabetes Care, LLC

www.prodigymeter.com 16

Prodigy Diabetes Care, LLC

1.800.243.2636 17

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Preparing the Lancing Device STEP 1: Remove the cap of the lancing device by twisting it off. See Figure 7. STEP 2: Insert a sterile lancet into the lancet holder of the lancing device and push down firmly until it is fully seated. Do not twist the lancet. See Figure 8. STEP 3: Remove the protective cap from the lancet by twisting it and then save it for later use. See Figure 9.

Figure 7

STEP 4: Replace the cap onto the lancing device. Screw the cap until it is snug but not too tight. STEP 5: Set the Lancing Level. The adjustable tip offers five (5) levels of skin penetration. To select the desired depth, twist the adjustable tip in either direction until the number lines up with the arrow. To select the best depth: 1–2 for soft or thin skin, 3 for average skin, 4–5 for thick or callused skin. See Figure 10.

Figure 8

Figure 11

Getting a Blood Sample Figure 9

www.prodigymeter.com 18

STEP 6: Cock the Lancing Device. Slide the ejection/cocking control back until it clicks. If it does not click, the Lancing Device may have been cocked when the lancet was inserted. See Figure 11. *The Lancing Device is prepared and ready to lance your finger for a blood sample.

Figure 10

Prodigy Diabetes Care, LLC

Warning: To reduce the risk of infection: • Never share a lancet or lancing device. • 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. • These devices are intended to be used for patient selfmonitoring and should not be used to collect blood from more than one person as this poses a risk of transmitting blood-borne pathogens such as Hepatitis B or HIV.

STEP 1: Wash Your Hands and Puncture Site Use warm, soapy water. Rinse and dry your hands thoroughly. STEP 2: Select and Lance a Puncture Site • Fingertip Figure 12 Hold the Lancing Device firmly against the side of your finger. Press the release button. You will hear a click, indicating that the puncture is complete. See Figure 12. Prodigy Diabetes Care, LLC

1.800.243.2636 19

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Introduction to Prodigy® Meters • Sites other Than Your Fingertip Please refer to the “About Alternate Site Testing (AST)” Section. Please consult your healthcare professional before obtaining blood from sites other than your fingertip.

Intended Use

Prodigy® blood glucose monitoring systems are intended for use outside the body (in vitro diagnostic use only) and should only be used for blood glucose (blood sugar) testing with fresh capillary whole blood samples. These systems are intended for use in the home and in clinical settings and should not be used for the diagnosis of diabetes or for the testing of newborns.

STEP 3: Obtain a Blood Sample Do not smear the blood sample. Figure 14 Figure 13 See Figure 13. To obtain the most accurate results, wipe off the first drop of blood and gently squeeze another drop of blood. See Figure 14. STEP 4: Remove the Lancet Remove the cap of the lancing device by twisting it off. Place the protective cap back on the exposed tip of the lancet by pushing the lancet into it. See Figure 15.

Prodigy Diabetes Care, LLC

Prodigy® meters, test strips and control solutions have been designed, tested and proven to work together as a system to produce accurate blood glucose test results.

Figure 15

www.prodigymeter.com 20

Blood glucose is measured by an electric current that is produced when a blood sample mixes with the reagent (special chemicals) of the test strip. The electrical current changes with the amount of glucose in the blood sample. Prodigy® meters measure the strength of the electrical current, calculates your blood glucose level and then displays your result in either mg/dL or mmol/L.

Important: Use only Prodigy® control solutions and test strips with your Prodigy® meter. Using other test strips and control solutions with this meter can produce inaccurate results.

*Always use caution when removing the lancet. Discard the lancet according to your local safety regulations. Warning: The first drop of blood usually contains tissue fluid and serum, which may affect the test result. It should be discarded.

Test Principle

Prodigy Diabetes Care, LLC

1.800.243.2636 21

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Contents of the Prodigy AutoCode® Meter The Prodigy AutoCode® meter is available as a meter only or as a meter kit. Please check the “REF” number marked on the outside of the box to see if you have purchased a “Meter” or a “Meter Kit.” Please review the contents of your purchase to confirm that all the components are included as listed below: Meter Includes

• Prodigy AutoCode® Meter • Two (2) AAA Batteries • Carrying Case • Complete Instructions: 1. Manual 2. Logbook 3. Quick Reference 4. Warranty Card

Meter Kit Includes

• Prodigy AutoCode® Meter • Two (2) AAA Batteries • Prodigy® Control Solution (4 mL) • Prodigy® Test Strips (10 ct) • Sterile Lancets (10 ct) • Lancing Device • Carrying Case • Complete Instructions: 1. Manual 2. Logbook 3. Quick Reference 4. Warranty Card

(Additional supplies can be purchased from your provider.)

Important: Please review the contents of your purchase. If any items are missing, please return your meter to the place of purchase.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 22

Prodigy Diabetes Care, LLC

1.800.243.2636 23

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Setting Up the Prodigy AutoCode® Meter Key Functions of the Meter

Meter Display

Day Average

Indicates that the displayed test result is an average.

Test Strip Slot

Test Result Area

Insert the test strip here. The meter will turn on automatically.

Time

Date

Guides you through the test using symbols and simple messages.

Appears when ambient temperature is outside of operating range.

Test Strip Symbol

Appears when the meter is turned on.

Talking Symbol

Confirms audio function.

Low Battery Symbol

Main Button

Turns the meter on or performs other functions described in this manual. Figure 16

Blood Drop Symbol

Port for USB Cable connection to your computer.

Flashes when sample should be applied.

Set Button

Unit of Measure

Data Port

Located on the back of the meter, inside the battery compartment; used to setup the meter.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 24

Indicates what unit of measure the test result is displayed in.

Appears when you review the memory.

Temperature Symbol

Displays test results.

LCD Display

Memory Symbol

Figure 17

Appears when the battery power is low.

Voice Symbol Shows if audio function is on.

Control Solution Test Symbol

Shows that you are in control solution mode.

Prodigy Diabetes Care, LLC

1.800.243.2636 25

PRODIGY



Owner’s Manual

Speaking Function

The Prodigy AutoCode® meter talks you through each step of your testing procedure.

When does the meter speak?

What does the meter say?

When the meter is turned on.

Your Prodigy® meter is on. Please wait. Please insert the test strip.

When room temperature is outside operating range; which is 50°F–104°F (10°C–40°C).

Room temperature is out of range.

When the meter is ready to test ( appears on display).

Please apply blood into the test strip.

When the test is completed (the result appears on the display).

Blood glucose (number) milligrams per deciliter/ millimoles per liter.

When you turn off the meter.

Goodbye.

When a used test strip is inserted.

Test strip has been used.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 26

PRODIGY



Owner’s Manual

Setup Steps

The Prodigy AutoCode® meter has the language, volume, time, date and unit of measure presets. However, if you replace the batteries, you should check the time and date. STEP 1: Insert the Batteries Open the battery cover located on the backside of the meter. Insert two (2) AAA Alkaline batteries and align them properly. STEP 2: Enter Setup Mode Press and hold the “SET” button located in the battery compartment. The meter is now in the setup mode. Voice Speaks: “Your Prodigy® meter is on. Please wait. Setting mode. English.” STEP 3: Select Language The language option appears first with “L-1” on the LCD. By default, “L-1” indicates the default language (English); “L-2” indicates the second language (Spanish); “L-3” indicates the third language (French); and “L-4” indicates the fourth language (Arabic). See Figure 18.

Figure 18

Press the “M” button to select a language. With the correct language selected, press the “SET” button and a number will appear.

Prodigy Diabetes Care, LLC

1.800.243.2636 27

PRODIGY



Owner’s Manual



Owner’s Manual

STEP 7: Set the Date Press and release the “M” button to advance the date. With the correct date on the display, press the “SET” button and the time will appear on the display with the hour segment flashing. See Figure 23.

STEP 4: Setting Volume Level The meter displays a number. • Numbers 1 to 3 indicate speaking volume from low to high, where “ ” is displayed on the LCD during testing. See Figure 19. • Number 0 indicates that the speaking function is turned off. See Figure 20.

Figure 19

Press the “M” button to select the speaking volume. Then press the “SET” button and the year segment will appear and start flashing. STEP 5: Set the Year Press and release the “M” button to advance the year. With the correct year on the display, press the “SET” button and the date will appear on the display with the month segment flashing. See Figure 21. STEP 6: Set the Month Press and release the “M” button to advance the month. With the correct month on the display, press the “SET” button and the date segment will start flashing. See Figure 22.

PRODIGY

Figure 20

Figure 21

STEP 8: Set the Hour Press and release the “M” button to advance the hour. With the correct hour on the display, press the “SET” button and the minutes segment will start flashing. See Figure 24. STEP 9: Set the Minutes Press and release the “M” button to advance the minutes. With the correct minutes on the display, press the “SET” button and the current unit of measurement will start flashing. See Figure 25. Important: Day averages are calculated from results obtained during the 7, 14 and 28 days preceding the current date and time settings.

Figure 23

Figure 24

Figure 25

Figure 22

Prodigy Diabetes Care, LLC

www.prodigymeter.com 28

Prodigy Diabetes Care, LLC

1.800.243.2636 29

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Performing a Blood Glucose Test STEP 1: Insert the Test Strip Insert a test strip with the contact bar end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. See Figure 30.

STEP 10: Select Unit of Measurement Press and release the “M” button until the unit of measurement you are choosing appears on the display. Press the “SET” button and the memory segment will start flashing. See Figures 26 and 27. Your meter can display test results in milligrams per deciliter (mg/dL) or millimoles per liter (mmoL/L). • The mg/dL unit is standard in the United States. • The mmol/L unit is standard in Canada. STEP 11: Delete Memory When the “dEL” symbol and the flashing “ ” symbol appear on the display, you can choose to clear the memory. If you do not want to clear the memory, press the “SET” button again to skip this step. If you want to clear ALL memory, press the “M” button for (4) four seconds and both “dEL” and “ ” will flash. Press the “M” button again to delete ALL memory. The “- - -” will appear to indicate all memory has been deleted and the meter will turn off. See Figure 28.

Voice Speaks: “Your Prodigy® meter is on. Please wait. Please apply blood into the test strip.”

Figure 26

Figure 27

STEP 2: Apply Blood Sample When the meter shows the “ ”, apply blood to the opening of the absorbent channel of the test strip where it meets the narrow channel. Blood will be drawn into the test strip. See Figure 31. If the test strip confirmation window is full (See Figure 32), you will hear a beep. Voice Speaks: “Now testing.” If the confirmation window is not full, “L-b” is displayed and a new test strip will need to be used.

Figure 28

If you have trouble filling the test strip, please contact Customer Care at 1.800.243.2636 for assistance.

Figure 32

Figure 29

www.prodigymeter.com 30

Figure 31



Setup is now complete. Press the “SET” button. “OFF” is displayed and the meter turns off. See Figure 29. Prodigy Diabetes Care, LLC

Figure 30

Prodigy Diabetes Care, LLC

1.800.243.2636 31

PRODIGY



Owner’s Manual



Owner’s Manual

Using the Meter Memory

Caution: DO NOT: • Smear or scrape the blood onto the test strip. • Apply blood to the test strip when the test strip is not in the meter. • Put blood or foreign objects into the test strip slot.

The Prodigy AutoCode® meter stores a maximum of the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14 and 28–day averages of your blood glucose test results. You can review the individual or average test results by entering the memory mode.

STEP 3: Read Your Result After the meter counts down from 6 to 1, your blood glucose test result appears along with the unit of measure, date and time. See Figure 33.

STEP 1: Enter the Memory Mode While the meter is turned off, press the “M” button twice. The 7–day average will appear, indicating that you are in the memory mode. If you continue to press the “M” button, the 14 and 28–day averages will appear in order. You can then review the last 450 individual test results in memory.

Voice Speaks: “Blood glucose 108 mg/dL.” This blood glucose result is automatically stored in the meter memory. Turn the meter off by removing the test strip. Discard the used test strip carefully to avoid contamination. Important: If you do not apply a blood sample within (4) four minutes, the meter will automatically turn off. You must remove the test strip and re-insert it again to turn on the meter and restart the test procedure.

PRODIGY

Figure 33

Caution: If you cannot test due to a problem with your testing supplies, contact Customer Care at 1.800.243.2636. Failure to test could delay treatment and/or lead to serious medical conditions.

When using the meter for the first time or when the memory has been deleted, “- - -” appears, indicating there are no test results in the meter memory. See Figure 34. STEP 2: Recalling Average Test Results The 7–day average is calculated from the blood glucose results obtained during the last 7 days. It also indicates how many blood glucose tests have been performed within this period, e.g., 21 (21 tests in the last 7 days). See Figure 35. The 14–day average is calculated from the blood glucose test results obtained during the last 14 days. See Figure 36.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 32

Figure 34

Prodigy Diabetes Care, LLC

Figure 35

Figure 36

1.800.243.2636 33

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Specifications It, too, indicates how many blood glucose tests have been performed, e.g., 41 (41 tests in the last 14 days). The 28–day average shows the same information. STEP 3: Recalling Individual Test Results After the 28–day average, the most recent test result with date and time will be shown. Press the “M” button once and the next most recent test result will appear. See Figure 37.

Dimensions: 3.63 in. (L) x 2.05 in. (W) x 0.75 in. (H) 92 mm (L) x 52 mm (W) x 19 mm (H) Weight: 2.76 oz with battery 55 g Power Source: Two (2) 1.5 Volt AAA Alkaline Batteries Battery Life: Over 1,000 tests Display: LCD Memory: 450 test results with date and time

Each time you press and release the “M” button, the meter will recall up to your last 450 test results in order. When the memory is full, the oldest test result is dropped as the newest is added. After reaching the last individual result, it will return back to the 7–day average. Figure 37

STEP 4: Exit the Memory Mode Press and hold the “M” button for two (2) seconds to turn off the meter. Important: If you do not press any buttons for one (1) minute, the meter will display “OFF” and turn off automatically.

External Output: USB Data Port Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto turn-off after two (2) minutes without action Temperature warning Operating Condition: 50°F – 104°F (10°C – 40°C), below 85% R.H. (non-condensing) Storage/Transportation Condition: 39.2°F – 115°F (4°C – 46°C), below 85% R.H. Measurement Units: mg/dL or mmol/L Measurement Range: 20 – 600 mg/dL (1.1– 33.3 mmol/L) The specifications may be changed without prior notice.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 34

Prodigy Diabetes Care, LLC

1.800.243.2636 35

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Contents of the Prodigy Pocket® Meter The Prodigy Pocket® meter is available as a meter only or as a meter kit. Please check the “REF” number marked on the outside of the box to see if you have purchased a “Meter” or a “Meter Kit.” Please review the contents of your purchase to confirm that all the components are included as listed below: Meter Includes

• Prodigy Pocket® Meter* • One (1) 3V CR2032 Battery • Carrying Case • Complete Instructions: 1. Manual 2. Logbook 3. Quick Reference 4. Warranty Card

Meter Kit Includes

• Prodigy Pocket® Meter* • One (1) 3V CR2032 Battery • Prodigy® Control Solution (4 mL) • Prodigy® Test Strips (10 ct) • Sterile Lancets (10 ct) • Lancing Device • Carrying Case • Complete Instructions: 1. Manual 2. Logbook 3. Quick Reference 4. Warranty Card

(Additional supplies can be purchased from your provider.)

*Available in five colors (Blue, Green, Black, Pink and Camouflage).



Prodigy Diabetes Care, LLC

www.prodigymeter.com 36

Important: Please review the contents of your purchase. If any items are missing, please return your meter to the place of purchase.

Prodigy Diabetes Care, LLC

1.800.243.2636 37

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Setting Up the Prodigy Pocket® Meter Key Functions of the Meter

Meter Display Control Solution Test Symbol Shows that you are in control solution mode. Your test result will not be stored in meter memory.

Test Strip Slot Insert the test strip here. The meter will turn on automatically. Temperature Symbol Appears when ambient temperature is outside of operating range.

LCD Display Guides you through the test using symbols and simple messages.

Main Button Turns the meter on or performs other functions described in this manual.

Figure 38

Test Result Area Displays test results. Blood Drop Symbol Flashes when sample should be applied.

Set Button Located in the battery compartment; used to set up the meter. Figure 39

Data Port USB Port for USB cable connection to your computer.

Time Date

Figure 41

Unit of Measure Appears with the test result to indicate what unit of measure the test result is displayed in.

Low Battery Symbol Appears when the battery power is low. Day Average Indicates that the displayed test result is an average. Test Strip Symbol Appears when the meter is turned on.

Memory Symbol Appears when you review the memory.

Figure 40

Prodigy Diabetes Care, LLC

www.prodigymeter.com 38

Prodigy Diabetes Care, LLC

1.800.243.2636 39

PRODIGY



Owner’s Manual

Setup Steps

The Prodigy Pocket® meter has the date, time and unit of measurement presets. However, if you replace the battery, you should check and update the time and date. STEP 1: Insert the Battery Open the battery cover located on the backside of the meter. Insert one (1) 3 Volt CR2032 lithium battery. The meter should beep and turn on. STEP 2: Enter Setup Mode Start with the meter off. Then press the “SET” button located in the battery compartment. The meter is now in the setup mode. STEP 3: Set the Year The year appears with the number flashing. Press and release the “M” button to advance the year. With the correct year on the display, press the “SET” button and the date will appear on the display with the month segment flashing. See Figure 42. STEP 4: Set the Month Press and release the “M” button to advance the month. With the correct month on the display, press the “SET” button and the date segment will start flashing. See Figure 43.

Figure 42

PRODIGY



Owner’s Manual

STEP 5: Set the Date Press and release the “M” button to advance the date. With the correct date on the display, press the “SET” button and the time will appear on the display with the hour segment flashing. See Figure 44.

Figure 44

STEP 6: Set the Hour Press and release the “M” button to advance the hour. With the correct hour on the display, press the “SET” button and the minutes segment will start flashing. See Figure 45.

Figure 45

STEP 7: Set the Minutes Press and release the “M” button to advance the minutes. With the correct minute on the display, press the “SET” button and the current unit of measurement will start flashing. See Figure 46.

Figure 46

Important: Day averages are calculated from results obtained during the 7, 14 and 28 days preceding the current date and time settings. When the date and time are changed, the 7, 14 and 28–day averages may change. Figure 43

Prodigy Diabetes Care, LLC

www.prodigymeter.com 40

Prodigy Diabetes Care, LLC

1.800.243.2636 41

PRODIGY



Owner’s Manual

STEP 8: Unit of Measure Press and release the “M” button until the unit of measurement you are choosing appears on the display. See Figures 47 and 48.

Figure 47

Your meter can display test results in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L). • The mg/dL unit is standard in the United States. • The mmol/L unit is standard in Canada.

Figure 48

PRODIGY



Owner’s Manual

STEP 9: Delete Memory Press the “SET” button and “dEL” will appear with the flashing “ ” symbol. When the “dEL” symbol and the flashing “ ” symbol appear on the display, you can choose to clear the memory. If you do not want to clear the memory, press the “SET” button again to skip this step. If you want to clear ALL memory, press and hold the “M” button for four (4) seconds. The “- - -” image will appear on the LCD screen to indicate that all memory Figure 49 has been deleted. Setup is now completed. Press the “SET” button to turn off the meter. “OFF” is displayed before shut down. See Figures 49 and 50. Figure 50

Prodigy Diabetes Care, LLC

www.prodigymeter.com 42

Prodigy Diabetes Care, LLC

1.800.243.2636 43

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Performing a Blood Glucose Test STEP 1: Insert the Test Strip Insert a test strip with the contact bar end entering into the test slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. See Figure 51.

Caution: DO NOT: • Smear or scrape the blood onto the test strip. • Apply blood to the test strip when the test strip is out of the meter. • Put blood or foreign objects into the test strip port.

STEP 2: Apply Blood Sample When the meter shows the “ ”, apply blood to the opening of the absorbent channel of the test strip where it meets the narrow channel. Blood will be drawn into the test strip. See Figure 52. The test strip confirmation window should be completely filled before the meter begins to count down. The meter will beep when the confirmation window is full. See Figure 53.

Figure 51

If you have trouble filling the test strip, please contact Customer Care at 1.800.243.2636 for assistance.

STEP 3: Read Your Result After the meter counts down from 6 to 1, your blood glucose test result appears along with the unit of measure, date and time. This blood glucose result is automatically stored in the meter memory. Turn the meter off by removing the test strip. Discard the used test strip carefully to avoid Figure 54 contamination. See Figure 54. Important: If you do not apply a blood sample within five (5) minutes, the meter will automatically turn off. You must remove the test strip and re-insert it again to turn on the meter and restart the test procedure. Caution: If you cannot test due to a problem with your testing supplies, contact Customer Care at 1.800.243.2636. Failure to test could delay treatment and/or lead to serious medical conditions.

Figure 52

Prodigy Diabetes Care, LLC

Figure 53

www.prodigymeter.com 44

Prodigy Diabetes Care, LLC

1.800.243.2636 45

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Using the Meter Memory The Prodigy Pocket® stores the 120 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14 and 28–day averages of your blood glucose test results. You can review the individual or average test results by entering the memory mode.

The 14–day average is calculated from the blood glucose results obtained during the last 14 days. See Figure 57.

STEP 1: Enter the Memory Mode While the meter is turned off, press the “M” button twice. The 7-day average will appear, indicating that you are in the memory mode. If you continue to press the “M” button, the 14 and 28–day averages will appear in order. You can then review the last 120 individual test results in the memory. When using the meter for the first time, “- - -” appears, showing that there are no test results in the memory. Figure 55 See Figure 55.

Figure 57 It, too, indicates how many blood glucose tests have been performed, e.g., 41 (41 tests in the last 14 days). The 28–day average shows the same information.

STEP 2: Recalling Average Test Results The 7–day average is calculated from the blood glucose results obtained during the last 7 days. It also indicates how many blood glucose tests have been performed within this period, e.g., 21 (21 tests in the last 7 days). See Figure 56.

Figure 56

STEP 3: Recalling Individual Test Results After the 28–day average, the most recent test result with date and time will be shown. Press the “M” button once and the next most recent test result will appear. Each time you press and release the “M” button, the meter will recall up to your last 120 test results in order. When the memory is full, the oldest result is dropped as the newest is added. After reaching the last set of results, the meter will display the 7–day average again. See Figures 57 and 59. STEP 4: Exit the Memory Mode Press and hold the “M” button for three (3) seconds to turn off the meter.

Figure 58

Figure 59

Important: If you do not press any button for one (1) minute, the meter will show “OFF” and turn off automatically. Prodigy Diabetes Care, LLC

www.prodigymeter.com 46

Prodigy Diabetes Care, LLC

1.800.243.2636 47

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Specifications Dimensions: 3.54 in. (L) x 1.38 in. (W) x 0.69 in. (H) 90 mm (L) x 35 mm (W) x 17.5 mm (H) Weight: 1.2 oz with battery 36 g Power Source: One (1) 3 Volt CR2032 Battery Battery Life: Over 1,000 tests Display: LCD Memory: 120 test results with date and time External Output: USB Data Port Auto electrode inserting detection Auto sample loading detection Auto reaction time count-down Auto turn-off after two (2) minutes without action Temperature warning Operating Condition: 50°F –104°F (10°C –40°C), below 85% R.H. (non-condensing) Storage/Transportation Condition: 39.2°F –115°F (4°C –46°C), below 85% R.H. Measurement Units: mg/dL or mmol/L Measurement Range: 20 – 600 mg/dL (1.1– 33.3 mmol/L) The specifications may be changed without prior notice.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 48

Prodigy Diabetes Care, LLC

1.800.243.2636 49

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Contents of the Prodigy Voice® Meter The Prodigy Voice® meter is available as a meter kit only. Please review the contents of your purchase to confirm that all the components are included as listed below: Meter Kit Includes • Prodigy Voice® Talking Meter • Two (2) AAA Alkaline Batteries • Prodigy® Control Solution (4 mL) • Prodigy® Test Strips (10 ct) • Sterile Lancets (10 ct) • Lancing Device • Carrying Case • Complete Instructions: 1. Manual 2. Logbook 3. Quick Reference 4. Warranty Card Important: Please review the contents of your purchase. If any items are missing, please return your meter to the place of purchase.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 50

Prodigy Diabetes Care, LLC

1.800.243.2636 51

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Setting Up the Prodigy Voice® Meter Meter Display

Key Functions of the Meter Up & Down Buttons Used to navigate through the system.

Test Strip Slot Insert the test strip here. The meter will turn on automatically.

Blood Drop Symbol Flashes when sample should be applied.

LCD Display Displays symbols and test results.

Test Result Area Displays test results.

Repeat Button Repeats last message spoken.

Day Average Indicates that the displayed test result is an average.

“M” Button Turns the meter on or performs other functions described in this manual.

Set Button Used to setup the meter. Figure 79

Data Port Port for USB Cable connection to your computer. Prodigy Diabetes Care, LLC

Ear Phone Jack Used to attach headphones.

www.prodigymeter.com 52

Date

Test Strip Symbol Appears when the meter is turned on. Voice Symbol Shows if audio function is on. Unit of Measure Indicates what unit of measure the test result is displayed in.

Figure 80

Low Battery Symbol Appears when the battery power is low.

Time Control Solution Test Symbol Shows that you are in control solution mode.

Temperature Symbol Appears when ambient temperature is outside of operating range.

Prodigy Diabetes Care, LLC

Memory Symbol Appears when you review the memory.

1.800.243.2636 53

PRODIGY



Owner’s Manual

Speaking Function

The Prodigy Voice® meter talks you through each step of your setup, testing procedure and memory recall.

When does the meter speak?

What does the meter say?

When the meter is turned on.

Thank you for using Prodigy Voice®. Today’s date November 18, 2009. The time 10:08 PM.

When room temperature is outside operating range; which is 50°F–104°F (10°C–40°C).

Room temperature is out of range.

When the meter is ready to test ( appears on display).

Please apply blood to the test strip.

When the test is completed. (The result appears on display)

Your blood glucose (number) milligrams per deciliter/ millimoles per liter.

When you turn off the meter.

Goodbye.

When a used test strip is inserted.

Test strip has been used. Replace with a new one.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 54

PRODIGY



Owner’s Manual

Setup Steps

The Prodigy Voice® meter has the volume, time, date and unit of measure presets. However, if you replace the batteries, you should check the time and date. STEP 1: Insert the Batteries Open the battery cover located on the backside of the meter. Insert two (2) AAA Alkaline batteries and align them properly. See Figure 81. STEP 2: Enter Setup Mode Start with the meter off. Then press and hold the “SET” button located on the front of the meter until the meter speaks. The meter is now in setup mode. See Figure 82.

Figure 81

Voice speaks: “Your Prodigy® meter is on. You are now in setting mode.”

Figure 82

Prodigy Diabetes Care, LLC

1.800.243.2636 55

PRODIGY



Owner’s Manual

STEP 3: Setting Volume Level The meter displays “VOL” Press the “Up” or “Down” button to select the speaking volume. See Figure 83. • Number 0 indicates that the speaking function is turned off. • Numbers 1 to 7 indicate speaking volume from low to high, where “ ” is displayed on the LCD during testing.



Owner’s Manual

STEP 6: Set the Date Press the “Up” or “Down” button to advance the date. With the correct date on the display, press the “SET” button and the time will appear on the display with the hour segment flashing. See Figure 86. Figure 83

Voice speaks: “The Date 18.”

Figure 86

STEP 7: Set the Hour Press the “Up” or “Down” button to advance the hour. With the correct hour on the display, press the “SET” button and the minutes segment will start flashing. See Figure 87.

Voice speaks: “Volume Level 4.” Then press the “SET” button and the year segment will appear and start flashing. STEP 4: Set the Year Press the “Up” or “Down” button to advance the year. With the correct year on the display, press the “SET” button and the date will appear on the display with the month segment flashing. See Figure 84.

PRODIGY

Voice speaks: “The Hour 10 PM.”

Figure 84

Voice speaks: “The Year 2009.”

Voice speaks: “The Minutes 08.”

STEP 5: Set the Month Press the “Up” or “Down” button to advance the month. With the correct month on the display, press the “SET” button and the date segment will start flashing. See Figure 85.

Figure 87

STEP 8: Set the Minutes Press the “Up” or “Down” button to advance the minutes. With the correct minutes on the display, press the “SET” button and the current unit of measurement will start flashing. See Figure 88. Figure 88

Voice speaks: “The Month November.” Figure 85

Prodigy Diabetes Care, LLC

www.prodigymeter.com 56

Prodigy Diabetes Care, LLC

1.800.243.2636 57

PRODIGY



Owner’s Manual

STEP 9: Select Unit of Measurement Press and hold the “Up” or “Down” button until the unit of measurement you are choosing appears on the display. Press the “SET” button and the memory segment will start flashing. Your meter can display test results in milligrams per deciliter (mg/dL) or millimoles per liter (mmoL/L). See Figure 89. • The mg/dL unit is standard in the United States. • The mmol/L unit is standard in Canada and Europe.

PRODIGY



Owner’s Manual

If you do not want to clear the memory, press the “SET” button to skip this step. If you want to clear ALL memory, press and hold the “M” button for five (5) seconds. “- - -” will appear to indicate all memory has been deleted. See Figure 91. Voice speaks: “All records have been deleted.” Figure 89

Voice speaks: “Blood glucose unit is mg/dL.” Important: Day averages are calculated from results obtained during the 7, 14, 21, 30, 60 and 90 days preceding the current date and time settings.

Figure 91

Setup is now completed. “OFF” is displayed before shut down and the meter will audibly summarize your settings. See Figure 92. Voice speaks: “Volume level 4; The date November 18, 2009; The time 10:08 PM; mg/dL; Goodbye.” Figure 92

STEP 10: Delete Memory When the “dEL” symbol and the “ ” symbol appear on the display, you can choose to clear the memory. See Figure 90. Voice speaks: “Deleting record function: To skip, press ‘Set’ button. If you press the ‘M’ key for five (5) seconds, all records will be deleted.” Figure 90

Prodigy Diabetes Care, LLC

www.prodigymeter.com 58

Prodigy Diabetes Care, LLC

1.800.243.2636 59

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Performing a Blood Glucose Test Tips for Applying Blood to Test Strips without Sight

Using the following five (5) tips may help you place a blood sample into the test strip successfully if you have little or no vision. The examples describe two (2) ways to bring the sample and the test strip together. Other techniques may work just as well. Keep experimenting until you have a technique that consistently works for you. 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— Aim for the Tip The 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 Prodigy Diabetes Care, LLC

www.prodigymeter.com 60

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 beep then 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 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. Prodigy Diabetes Care, LLC

1.800.243.2636 61

PRODIGY



Owner’s Manual

• Step 4—Using overlapping dragging motions in an upward direction, repeat the motion around the puncture sight until you hear the meter beep then 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 to practice, practice, practice. We suggest using 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 (3) tests in a row. It can be helpful to have someone with sight to watch you practice in order to provide feedback or to answer any questions you may have.

PRODIGY



Owner’s Manual

Performing a Blood Glucose Test

STEP 1: Insert the Test Strip Insert a test strip with the contact bars end entering into the test strip slot first. Push the test strip as far as it will go without bending it. The meter turns on automatically. See Figure 93. Voice speaks: “Thank you for using Prodigy Voice®. Today’s date November 18, 2009. The time 10:08 am. Please apply blood to the test strip.” STEP 2: Apply Blood Sample When the meter shows the “ ” symbol, apply blood to the opening of the absorbent channel of the test strip where it meets the narrow channel. Blood will be drawn into the test strip. See Figure 94.

Figure 93

Important: If you do not apply a blood sample within two (2) minutes, the meter will automatically turn off. You must remove the test strip and re-insert it again to turn on the meter and restart the test procedure. The test strip confirmation window should be completely filled before the meter begins to count down. The meter will beep when the confirmation window is full. Voice speaks: “Now testing.” Figure 94

Prodigy Diabetes Care, LLC

www.prodigymeter.com 62

Prodigy Diabetes Care, LLC

1.800.243.2636 63

PRODIGY



Owner’s Manual

Caution: DO NOT: • Smear or scrape the blood onto the test strip. • Apply blood to the test strip when the test strip is not in the meter. • Put blood or foreign objects into the test strip slot. If you have trouble filling the test strip, please contact Customer Care at 1.800.243.2636 for assistance.

PRODIGY



Owner’s Manual

STEP 4: Remove the Lancet Always use caution when removing the lancet. Take the lancet out carefully. Place the protective cap back on the lancet’s exposed tip. If using a twist lancet, place the cap on a hard surface and push the exposed tip into the protective cap and discard properly. Caution: If you cannot test due to a problem with your testing supplies, contact Customer Care at 1.800.243.2636. Failure to test could delay treatment and/or lead to serious medical conditions.

STEP 3: View and Hear Your Result After the meter counts down from 6 to 1, your blood glucose test result appears along with the unit of measurement. Voice speaks: “Your blood glucose 106 mg/dL.” The blood glucose test result is automatically stored in the meter memory. Turn the meter off by removing the test strip. Discard the used test strip carefully to avoid contamination. See Figure 95. Note: If at any time you need to hear the last message spoken, press the “Repeat” button and the last message will be repeated.

Prodigy Diabetes Care, LLC

Figure 95

www.prodigymeter.com 64

Prodigy Diabetes Care, LLC

1.800.243.2636 65

PRODIGY



Owner’s Manual

PRODIGY



Owner’s Manual

Using the Meter Memory The Prodigy Voice™ meter stores the 450 most recent blood glucose test results with date and time in its memory. It also provides you with 7, 14, 21, 30, 60 and 90–day averages of your blood glucose test results. You can review the individual or average test results. OPTION 1: Recalling Individual Test Results While the meter is turned off, press the “M” button to turn the meter on. After the prompts, press the “M” button again to enter memory mode and recall individual test results. Press the “Up” or “Down” buttons to advance to the next or previous test results. See Figure 96. Voice speaks: “Memory record for November 18, 2009, 10:08 PM. Your blood glucose 89 mg/dL.”

Prodigy Diabetes Care, LLC

Figure 98

Voice speaks: “7-day average 106 mg/dL. Figure 96

Press the “Up” button to advance to the next average test result. Note: The meter reports 7, 14, 21, 30, 60 and 90–day averages. Exit the Memory Mode To exit the memory mode during either option, press and hold the “M” button for approximately five (5) seconds and the meter will turn off.

Figure 97

www.prodigymeter.com 66

Voice speaks: “Your Prodigy® meter is on. Today’s date November 18, 2009; The time 10:08 PM. Please insert the test strip.”

After the audible prompts, press the “M” button for two (2) seconds and the meter will recall the 7-day average. See Figure 98.

Once you scroll through all the individual test results in the meter memory, “End” will display and the meter will turn off. See Figure 97. Note: Once you are in the individual test recall mode, you cannot advance to the averaging simply by pressing the “M” button.

OPTION 2: Recalling Average Test Results While the meter is off, press the “M” button and the meter will turn on.

Important: If you do not press any buttons for two (2) minutes, the meter will display “OFF” and turn off automatically.

Prodigy Diabetes Care, LLC

1.800.243.2636 67

PRODIGY



Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Specifications

Viewing Results on a Personal Computer

Dimensions: 3.94 in. (L) x 2.25 in. (W) x 0.75 in. (H) 100 mm (L) x 57 mm (W) x 19 mm (H)

Test results in memory can be transmitted to your personal computer. Prodigy® Diabetes Management Software and a cable are needed before installation.

Weight: 1.2 oz with battery 36 g Power Source: Two (2) 1.5 Volt AAA Alkaline Batteries Battery Life: Over 1,000 tests

STEP 1: Install Software Install Prodigy® Diabetes Management Software on your computer. STEP 2: Connect to a Personal Computer Connect the cable to your computer. Then, connect the cable to the data port of the meter. “Lnk” (Pcl appears on the Prodigy Voice®) will appear if the cable is correctly connected to the meter and PC.

Display: LCD Memory: 450 test results with date and time External Output: USB Data Port Auto electrode inserting detection

Important: The Prodigy AutoCode®, Prodigy Pocket® and Prodigy Voice® meters use a USB cable to connect to a computer.

Auto sample loading detection Auto reaction time count-down Auto turn-off after two (2) minutes without action Temperature warning Operating Condition: 50°F –104°F (10°C –40°C), below 85% R.H. (non-condensing) Storage/Transportation Condition: 39.2°F– 115°F (4°C –46°C), below 85% R.H. Measurement Units: mg/dL or mmol/L Measurement Range: 20–600 mg/dL (1.1– 33.3 mmol/L) The specifications may be changed without prior notice.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 68

For the Prodigy AutoCode®, Prodigy Pocket® and Prodigy Voice® meters, “USb” will appear on the display, indicating that the meter is successfully communicating to your computer. You can begin to download the data from the meter.

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. Caution: While the meter is connected to the PC, it is unable to perform a blood glucose test.

Prodigy Diabetes Care, LLC

1.800.243.2636 69

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Caring for your Prodigy® Meter Cleaning your System

Storing Your System

Do not get any liquids, dirt, dust, blood or control solution inside the meter through the test strip port or the data port. Never spray cleaning solution on the meter or immerse it in any liquid.

*Your meter is a precision instrument. Please handle it with care.

Your Prodigy® meter should be cleaned whenever it is visibly dirty by wiping the outside of the meter using a cloth dampened with either mild detergent mixed with water or 70% isopropyl (rubbing) alcohol. Do not use bleach or other harsh abrasives to clean your meter.

Lancing Device Wipe your Prodigy® Lancing Device with a soft cloth dampened with water and mild detergent or 70% isopropyl (rubbing) alcohol. Do not immerse the lancing device in any liquid. Do not use bleach.

Disinfecting your System

If your Prodigy® meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be decontaminated prior to use by the second person. Lancing Device Disnifect your Prodigy® Lancing Device about once a week. After cleaning the device, unscrew the cap and place it in 70% isopropyl (rubbing) alcohol for several minutes. Make sure the cap is completely dry before reattaching it to the device. Please contact Customer Care if you have any questions at 1.800.243.2636.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 70

The Prodigy® meters do not require special maintenance. • Store the meter, test strips and control solution in the carrying case after each use in a cool, dry place. • Do not refrigerate. • Do not store in the kitchen or bathroom.

Battery

The Prodigy Voice® and Prodigy AutoCode® meters come with two (2) 1.5 V AAA alkaline batteries. The Prodigy Pocket™ meter comes with one (1) CR2032 battery. Batteries are manufactured in a charged state and not designed for recharging. Recharging the batteries can cause battery leakage, or in some cases, high pressure rupture. Replace all batteries at the same time. Warning: Batteries can explode or leak and cause burns if installed backwards, disassembled, charged or exposed to water, fire or high temperatures.

Low Battery

The meter will alert you when the power is getting low by displaying two (2) different messages: 1. When the “ ” symbol appears alone on the display, the meter is functional and the result remains accurate, but you should change the battery as soon as possible. 2. When the “ ” symbol appears together with the “E-b” symbol on the display, the battery does not have enough power for a test. You must change the battery before using the meter. Prodigy Diabetes Care, LLC

1.800.243.2636 71

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

System Troubleshooting Battery Replacement

To replace the battery, make sure the meter is turned off. STEP 1: With the meter off, press the buckle on the battery cover and lift up to open the cover. STEP 2: Remove the old battery(s) and replace with new one(s). Be sure to align the battery(s) properly. STEP 3: Close the battery cover. If the meter does not power on after you have replaced the battery(s), check that the battery(s) is correctly installed. STEP 4: Turn the meter on by pressing the “M” button to check the time and date. Replacing the battery(s) does not affect the meter’s memory (previous test results stored in the memory). However, the date, time and units settings may need to be updated. Caution: As with all small objects, the battery should be kept away from small children. If the battery is swallowed, seek medical assistance immediately.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 72

Special Messages

Special messages and Error 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” in the “Error Messages” section. If you have a problem, please refer to the “Troubleshooting Guide” section. If you follow the actions recommended but the problem is not resolved, please contact Customer Care at 1.800.243.2636 for assistance. Message

What it means



“Lo” appears when your result is below the measurement limit, which is less than 20 mg/dL (1.1 mmol/L). “Lo” indicates hypoglycemia (low blood glucose). You should immediately consult your healthcare professional.



“HI” appears when your result is above the measurement limit, which is higher than 600 mg/dL (33.3 mmol/L). You should immediately consult your healthcare professional.

Prodigy Diabetes Care, LLC

1.800.243.2636 73

PRODIGY® Blood Glucose Meters

Owner’s Manual

Error Messages Message

PRODIGY® Blood Glucose Meters

Owner’s Manual

Troubleshooting Guide Description

What it means: Appears when the battery cannot provide enough power for a test.

v The meter does not display a message after inserting a test strip.

Probable Cause

Action

Battery exhausted.

Replace the battery.

Action: Replace the battery immediately.

Battery incorrectly installed or absent.

Check that the battery is correctly installed.

What it means: Appears when inserting a used test strip.

Test strip inserted upside down or incompletely.

Insert the test strip correctly with the bar end entering into the test strip first.

Action: Test with a new test strip. If the problem persists, please contact Customer Care at 1.800.243.2636.

Defective meter.

Please contact Customer Care at 1.800.243.2636 for assistance.

What it means: Appears when the environmental temperature is out of the system operating range (50°F–104° or 10°C–40°C). Action: Repeat the test after the meter and test strip are within the operating temperature range. What it means: Low blood alert Action: Apply more blood to the test strip within five (5) seconds of the error message. If time runs out, simply insert a new test strip. Prodigy Diabetes Care, LLC

www.prodigymeter.com 74

v The test does not start after applying the sample.

Probable Cause

Action

Insufficient blood sample.

Repeat the test using a new test strip with a larger blood sample.

Defective test strip.

Repeat the test with a new test strip.



Repeat the test with a new test strip. Apply sample only when the “ ” symbol appears on the display.

Sample applied after automatic shut-off. (Two (2) minutes after last user action).

Defective meter.

Please contact Customer Care at 1.800.243.2636 for assistance.

Prodigy Diabetes Care, LLC

1.800.243.2636 75

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

Information About your Prodigy® Meter Comparing Meter and Laboratory Results

v The control solution test is out of range.

Probable Cause

Action

Error in performing the test.

Read the instructions thoroughly and repeat the test again.

Control solution bottle not shaken well.

Shake the control solution bottle vigorously and repeat the test again.

Expired or contaminated control solution.

Check the expiration date or the discard 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 (68 –77°F/20 –25°C) before testing.

Test strip deterioration.

Please repeat the test with a new test strip.

Meter malfunction.

Please contact Customer Care at 1.800.243.2636 for assistance.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 76

The test results you obtain from your meter may differ somewhat from your laboratory results 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 as well as important information on limitations). To make an accurate comparison between meter and laboratory results, follow the guidelines below. Before you go to the laboratory: • Perform a control solution test to make sure that the meter is working properly. • It is strongly recommended to fast for at least eight (8) hours before doing comparison tests. • Take your meter with you to the laboratory. While at the laboratory: • Make sure that the samples for both tests (the meter test and the laboratory 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 gray top 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, especially if you have recently eaten, exercised, taken medication or experienced stress.1 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) Prodigy Diabetes Care, LLC

1.800.243.2636 77

PRODIGY® Blood Glucose Meters

Owner’s Manual

higher than blood drawn from a vein (venous sample) used for a lab test.2 Therefore, it is best to fast for eight (8) 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 bodily fluids (severe dehydration) may also cause a meter result to be different from a laboratory result. References: 1) Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51. 2) Sacks, D.B:“Carbohydrates.” Burtis,C.A, and Ashwood,E.R.(ed.),Tietz Textbook of Clinical Chemistry. Philadelphia:W.B. Saunders Company (1994),959.

PRODIGY® Blood Glucose Meters

Owner’s Manual

Expected Test Results Time of day

Plasma glucose Your target range range for people without diabetes

Fasting and before meal

Less than 110 mg/dL (6.1 mmol/L)

(mg/dL)/(mmol/L)

2 hours after meals

Less than 140 mg/dL (7.8 mmol/L)

(mg/dL)/(mmol/L)

Bedtime Not specified

(mg/dL)/(mmol/L)

Performance Characteristics

Between 2 AM and 4 AM

(mg/dL)/(mmol/L)

• Accuracy: ±15 mg/dL when glucose <75 mg/dL ±20% when glucose >75 mg/dL

Source: ADA Clinical Practice Recommendations 2008 Please work with your doctor to determine a target range that works best for you.

• Precision: This study shows the CV (correlation variation) is less than 5%. • The device has been certified to meet the following standards: 98/79/EC, IEC 60601-1, IEC 61010-1, IEC 60601-1-2, IEC61326, and ISO 15197

Not specified

Your Prodigy® meter is designed to help you and your healthcare professional manage your diabetes. You must always rely on your healthcare professional to interpret your test results and to decide how to treat your diabetes.

Unxpected Test Results

Unexpected test results can occur. When this happens, please refer to these cautions. Low Blood Glucose Test Results False low results may occur if you are severely dehydrated. If you think you are severely dehydrated, contact your healthcare professional immediately.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 78

Prodigy Diabetes Care, LLC

1.800.243.2636 79



PRODIGY® Blood Glucose Meters

Owner’s Manual

If your test result is lower than 70 mg/dL or “Lo” appears on your meter screen, this could be a result of hypoglycemia. Although this result could be due to a testing error, it is best to treat first and retest later. Contact your healthcare professional immediately. See Figure 99.

PRODIGY® Blood Glucose Meters

Owner’s Manual

Accuracy of Meter Measurements

FAQ: Can two (2) blood glucose meters produce different readings that are from the same blood sample? Does this make one reading more accurate than the other? Figure 99

High Blood Glucose Test Results If your test result is higher than 180 mg/dL, this could be a result of hyperglycemia. If you are uncertain about this test result, retest. If the result continues to be higher than 180 mg/dL, contact your healthcare professional immediately. If “Hi” appears on your meter screen, this could be a result of severe hyperglycemia (results higher than 600 mg/dL). Retest your blood glucose. If “Hi” appears again, contact your healthcare professional immediately. See Figure 100. Figure 100

Repeated Unexpected Test Results If you continue to get unexpected test results, check your blood glucose monitoring system by performing a control solution test. Refer to “Performing a Control Solution Test” section in this manaul. Unusual Red Blood Cell Count A hematocrit range (percentage of red blood cells in the blood) that is extremely high (above 55%) or low (below 30%) can also cause false readings.

Answer: Yes, different meters can produce different readings using the same blood sample. No, this does not necessarily mean that one result is more accurate than the other. The reasons for this are as follows: 1. The FDA recognized standard for glucose meter accuracy is ISO 15197: In Vitro Diagnostic Test Systems—Requirements for Blood Glucose Monitoring Systems for Self Testing in Managing Diabetes Mellitus. This standard sets accuracy requirements that manufacturers must meet before being approved by the FDA to market their glucose meters. 2. The accuracy requirements for the blood glucose monitoring system—meters and test strips—as stated in ISO 15197 is this: Ninety-five percent (95%) of the individual glucose results shall fall within ±15 mg/dL (0.83 mmol/L) of the results of the manufacturer’s measurement procedure at glucose concentrations < 75 mg/dL (<4.2 mmol/L) and within ± 20% at glucose concentrations ≥ 75 mg/dL ( ≥ 4.2 mmol/L). How does this answer the FAQ? The accuracy of the system is determined by a clinical study using 100 blood samples at interval glucose concentrations ranging from

Prodigy Diabetes Care, LLC

www.prodigymeter.com 80

Prodigy Diabetes Care, LLC

1.800.243.2636 81

PRODIGY® Blood Glucose Meters

Owner’s Manual

PRODIGY® Blood Glucose Meters

Owner’s Manual

< 50 mg/dL to over 400 mg/dL measured using both the manufacturer’s meter and a clinical blood glucose analyzer for comparison (reference measurement).

Symbols Information Symbol

Referent

Example 1 If the manufacturer’s reference measurement is 70 mg/dL this means that the meter measurements are considered accurate if they fall within ± 15 mg/dL of 70 mg/dL (from of 55 mg/dL to 85 mg/dL).



Do not re-use. Single use only.



Consult Operating Instructions.

If meter A produces a measurement of 60 mg/dL and meter B measures 80 mg/dL, then both are in the acceptable range and meet the accuracy requirement.



Keep away from sunlight.



Keep dry.



Temperature limitation.



Use by.



Date of manufacture.

LOT

Batch code.

REF

Catalog number.

SN

Serial number.

CONTROL

Control.

Each manufacturer has met the System Accuracy requirement as part of its testing to be cleared for marketing. In the System Accuracy, testing a distribution of blood glucose readings will result at the various glucose concentration levels for one manufacturer’s system. This is the same for other manufacturer’s systems. Because of the range of acceptable readings for the accuracy requirement, identical readings from two different meters on the same blood sample may not happen.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 82



Prodigy Diabetes Care, LLC

1.800.243.2636 83

PRODIGY® Blood Glucose Meters

Owner’s Manual

Warranty Information Limited Lifetime Warranty

Prodigy Diabetes Care, LLC extends a limited lifetime warranty to consumers who purchase a new Prodigy® brand meter. Under this limited lifetime warranty, your new meter is covered from the original date of purchase, as long as it has not been modified, altered, or misused. Under this limited lifetime warranty, Prodigy® will replace, free of charge, the meter if it is defective in material or workmanship. NO OTHER WARRANTIES, EXPRESS OR IMPLIED, ARE MADE. DDI WILL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING DIRECTLY OR INDIRECTLY FROM THE FAILURE OF THE PRODUCT TO PERFORM IN ACCORDANCE WITH SPECIFICATIONS. Some states do not allow the exclusion or limitation of other express or implied warranties or incidental or consequential damages, so the above limitations or exclusions may not apply to you.

Prodigy Diabetes Care, LLC

www.prodigymeter.com 84

Prodigy Diabetes Care, LLC 1.800.366.5901 9300 Harris Corners Parkway, Suite 450 Charlotte, NC 28269 EC REP AR REP Advena Ltd; 33 Bridge Street, Hereford HR4 9DQ, UK

For Customer Care call: 1.800.243.2636 www.prodigymeter.com ©2012 Prodigy Diabetes Care. Prodigy®, Prodigy Pocket®, Prodigy Voice® and Prodigy AutoCode® are registered trademarks of Prodigy Diabetes Care. All other trademarks are property of their respective owners. All rights reserved. PCM262 Rev.4 01/12