DDI Prodigy Pocket Owner'S Manual Download

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Blood Glucose Monitoring System

Owner’s Manual

Summary of Contents for Prodigy Pocket

Page 1: ...Blood Glucose Monitoring System Owner s Manual ...

Page 2: ...rt is available 24 hours 7 days a week by calling 1 800 243 2636 All questions about interpreting the results should be directed to your healthcare professionals The Prodigy PocketTM is the latest technology for blood glucose monitoring easy to use and will give you fast and accurate results with a minimal sample of blood It has a large screen display for easy reading and is small and lightweight ...

Page 3: ...nd control solutions that are not supplied by the manufacturer 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 Warning Keep the test strip vial away from children...

Page 4: ...ion Testing 16 About Prodigy Control Solution 16 Important Control Solution Test Information 17 Performing a Control Solution Test 18 Blood Glucose Testing 21 Preparing the Lancing Device 21 Getting a Blood Sample 22 Performing a Blood Glucose Test 24 Using the Meter Memory 26 Viewing Results on a Personal Computer 29 Caring for your Prodigy PocketTM Meter 30 Maintenance 30 Battery 30 Battery Repl...

Page 5: ...lts and you have followed all instructions described in the 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 indicates 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 mmo...

Page 6: ...dvantage 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 Food medication illness stress and exercise can affect blood glucose levels Capillary blood at the fingertip reflects these changes faster than capillary blood at ...

Page 7: ...e after taking insulin v Two hours or more after exercise v During steady state blood glucose conditions 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 the accuracy when using AST rub the puncture site before extracting blood ...

Page 8: ... sample mixes with the reagent special chemicals of the test strip The electrical current changes with the amount of glucose in the blood sample The Prodigy PocketTM Meter measures the strength of the electrical current calculates your blood glucose level and then displays your result in either mg dL or mmol L The Prodigy PocketTM Meter Test Strips and Control Solutions have been designed tested a...

Page 9: ...of your purchase If any items are missing please return your meter to the place of purchase Contents of the Prodigy PocketTM Meter REF 50300 Series Your Meter includes Prodigy PocketTM Meter One 1 3 Volt CR 2032 Battery Carrying Case Complete Instructions Manual Log Book Quick Reference Warranty Card You can purchase additional supplies from your provider REF 50360 or 70800 Series Your Meter Kit i...

Page 10: ...e The meter will turn on automatically LCD Display Guides you through the test using symbols and simple messages Set Button Located in the battery compartment used to set up the meter Data Port USB Port for USB Cable connection to your computer Main Button Turns the meter on or performs other functions described in this manual Figure 3 Back Figure 4 Back Figure 2 Front ...

Page 11: ...mple should be applied Test Strip Symbol Appears when the meter is turned on 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 Temperature Symbol Appears when ambient temperature is outside of operating range Memory Symbol Appears when you review the memory Day Average Indicates tha...

Page 12: ...t strip consists of the following parts Absorbent Channel Apply a drop of blood and it will be drawn in automatically Confirmation Window Shows whether enough blood has been drawn into the test strip s absorbent channel 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 unti...

Page 13: ...ng 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 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 str...

Page 14: ...P 2 Enter Set Up Mode Start with the meter off Then press the SET button located in the battery compartment The meter is now in the set up 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 7 ...

Page 15: ... With the correct hour on the display press the SET button and the minutes segment will start flashing See Figure 10 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 11 Important Day averages are calculated from results obtained during the 7 14 ...

Page 16: ...is standard in the United States The mmol L unit is standard in Canada STEP 9 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 and hold the M button for four 4 seconds The image will appear on the LCD screen to i...

Page 17: ... 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 make sure that you co...

Page 18: ...ps should come to room temperature 68 77 F 20 25 C before testing Use within a period of 90 days from the date that you first open it 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 Prodigy s control solution ranges are located on the back of the test strip vial T...

Page 19: ...urns on automatically See Figure 16 STEP 2 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 See Figure 17 Important Be sure that yo...

Page 20: ...tle again to get a second drop onto a clean non absorbent surface or on your fingertip first Then 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 The meter begins to count down See Figures 18 19 and 20 Caution To avoid contaminating the control solution with the content of the test strip DO NOT DIREC...

Page 21: ...e printed range See Figure 21 Out of Range Results If test results fall outside the range printed on the test strip vial check Trouble Shooting Guide located in the System Troubleshooting Section and repeat the test If you continue to get out of range 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 a...

Page 22: ...ng 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 24 Warning To reduce the c...

Page 23: ... until it clicks If it does not click the Lancing Device may have been cocked when the lancet was inserted See Figure 25 The Lancing Device is prepared and ready to lance your finger for a blood sample Getting a Blood Sample STEP 1 Wash Your Hands and the Puncture Site Use warm soapy water Rinse and dry your hands thoroughly STEP 2 Select and Lance a Puncture Site Fingertip Hold the Lancing Device...

Page 24: ...ctures in the same spot may cause soreness and calluses STEP 3 Obtain a Blood Sample Do not smear the blood sample To obtain the most accurate results wipe off the first drop of blood and gently squeeze another drop of blood See Figures 27 and 28 STEP 4 Remove the Lancet Take the lancet out carefully Place the protective cap back on the exposed tip of the lancet Always use caution when removing th...

Page 25: ... 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 30 The test strip confirmation window should be completely filled before the meter begins to count down The meter will beep when the confirmation window of the test strip is full See Figure 31 If not do not try to add more blood to the test strip Dis...

Page 26: ... 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 contamination See Figure 32 Important If you do not apply a blood sample within five 5 minutes the meter will automatically turn off You mus...

Page 27: ...verage test results by entering the memory mode 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 memory When using the meter for the first time ap...

Page 28: ...lso indicates how many blood glucose tests have been performed within this period e g 21 21 tests in the last 7 days See Figure 34 The 14 day average is calculated from the blood glucose results obtained during the last 14 days See Figure 35 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 Figure 35 ...

Page 29: ...u 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 Figure 36 STEP 4 Exit the Memory Mode Press and hold the M button for three 3 seconds to turn off the meter Important If you do not press...

Page 30: ...nect to a Personal Computer Connect the USB Cable to your computer Connect the USB Cable to the Data Port of the meter Lnk will appear if the USB cable is connected to the meter and PC 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 See Figures 37 and 38 STEP 3 Transmit Data Follow the instruc...

Page 31: ...f the meter Your meter is a precision instrument Please handle it with care Battery Your meter comes with one 1 3 Volt CR 2032 lithium 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 See Fi...

Page 32: ...rds until it is locked into place You should hear a beep STEP 3 If the meter does not power on after you have replaced the battery check that the battery is correctly installed with the side up STEP 4 Check the time and date Replacing the battery does not affect the meter s memory previous test results stored in memory However the date time and units settings may need to be updated Caution As with...

Page 33: ...Guide Section If you follow the actions recommended but the problem is not resolved please contact Technical Support at 1 800 243 2636 for assistance Special Messages System Troubleshooting Message What it says 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 yo...

Page 34: ...rip Error Messages Appears when the environmental temperature is below the system operation range 50 F 104 or 10 C 4 0 C Replace the battery immediately Test with a new test strip If the problem persists please contact Technical Support at 1 800 243 2636 Repeat the test after the meter and test strip are within the operation temperature range System Error Contact Technical Support at 1 800 243 263...

Page 35: ...sistance v The meter does not display a message after inserting a test strip Probable Cause What to Do Troubleshooting Guide v The test does not start after applying the sample Probable Cause What to Do 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 Sample applied after Repeat the test with a ne...

Page 36: ... is too warm or too cold Test strip deterioration Meter malfunction Read the instructions thoroughly and repeat the test again Shake the Control Solution bottle vigorously and repeat the test again Check the expiration date or the discard date of the Control Solution Control Solution meter and test strips should come to room temperature 68 77 F 20 25 C before testing Please repeat the test with a ...

Page 37: ...nformation 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 lab While at the laboratory Make sure that...

Page 38: ... mg dL 3 9 mmol L 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 body fluid severe dehydration may also cause a meter result to be different from a laboratory result References 1 Surwit R S and Feing...

Page 39: ...ment 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 noncondensing Storage Transportation condition 39 2 F 104 F 4 C 30 C below 85 R H Measurement Units mg dL or mmol L Meas...

Page 40: ...nce Characteristics Accuracy 15mg dL when glucose 75mg dL 20 when glucose 75mg dL Precision This study shows the CV correlation variation is less than 5 The device has certified to meet the following standards 98 79 EC IEC 60601 1 IEC 61010 1 IEC 60601 1 2 IEC61326 and ISO 15197 ...

Page 41: ...eals 140 7 8 Bedtime Not specified _______ mg dL mmol L Between 2 AM Not specified _______ mg dL mmol L and 4 AM Source ADA Clinical Practice Recommendations 2008 Please work with your doctor to determine a target range that works best for you The Prodigy Pocket TM is designed to help you and your healthcare professionals manage your diabetes You must always rely on your healthcare professionals t...

Page 42: ... 50302 B Blue REF 50303 G Green REF 50304 C Camouflage Meter Kit REF 50360 K Black REF 50361 P Pink REF 50362 B Blue REF 50363 G Green REF 50364 C Camouflage Meter Kit REF 70800 B Black REF 70801 P Pink REF 70802 B Blue REF 70803 G Green REF 70804 C Camouflage Prodigy PocketTM Meters are available in five 5 colors ...

Page 43: ...Diagnostic Devices Inc www prodigymeter com Prodigy Meter Owner s Manual 42 ...

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