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Intended Use

The system is intended for use outside the body (

in vitro

diagnostic use) by people with diabetes at home and

by health care professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. It is

intended to be used for the quantitative measurement of glucose (sugar) in fresh whole blood samples (from

the finger, palm, forearm, upper arm, calf and thigh).

It should not be used for the diagnosis of diabetes, or testing on newborns.

Test Principle

Your system measures the amount of sugar (glucose) in whole blood. The glucose testing is based on the

measurement of electrical current generated by the reaction of glucose with the reagent of the strip. The meter

measures the current, calculates the blood glucose level, and displays the result. The strength of the current

produced by the reaction depends on the amount of glucose in the blood sample.

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Содержание Prudential

Страница 1: ...Version 1 0 April 2010 311 4254100 001 MANUAL OWNER S BLOOD GLUCOSE MONITORING SYSTEM Prudential ...

Страница 2: ...g contents thoroughly and carefully Regular monitoring of your blood glucose levels can help you and your doctor gain better control of your diabe tes Due to its compact size and easy operation you can use the DIAVUE Prudential Blood Glucose Monitoring System to easily monitor your blood glucose levels by yourself anywhere any time If you have other questions regarding this product please contact ...

Страница 3: ...ence only Always consult your doctor to have the results interpreted 7 Before using this device to test blood glucose read all instructions thoroughly and practice the test Carry out all the quality control checks as directed 8 Keep the device and testing equipment away from young children Small items such as the battery cover batteries test strips lancets and vial caps are choking hazards 9 Use o...

Страница 4: ...TESTING 17 Control Solution Testing 17 Performing a Control Solution Test 18 TESTING WITH BLOOD SAMPLE 21 Overview of the Lancing Device 21 Setting up the Lancing Device 21 Preparing the Puncture Site 22 Alternative Site Testing 26 Performing a Blood Glucose Test 28 METER MEMORY 31 Reviewing Test Results 31 Reviewing Blood Glucose Day Average Results 32 Downloading Results onto a Computer 35 ...

Страница 5: ...ur Test Strips 39 Important Control Solution Information 40 SYSTEM TROUBLESHOOTING 41 Result Readings 41 Error Messages 43 Troubleshooting 45 DETAILED INFORMATION 47 Reference Values 47 Comparing Meter and Laboratory Results 48 SYMBOL INFORMATION 50 SPECIFICATIONS 52 ...

Страница 6: ...ce of your healthcare professional Use only fresh whole blood samples to test your blood glucose Using other substances will lead to incor rect results If you are experiencing symptoms that are inconsistent with your blood glucose test results and you have followed all the instructions given in this owner s manual contact your healthcare professional We do not recommend using this product on sever...

Страница 7: ...rom the finger palm forearm upper arm calf and thigh It should not be used for the diagnosis of diabetes or testing on newborns Test Principle Your system measures the amount of sugar glucose in whole blood The glucose testing is based on the measurement of electrical current generated by the reaction of glucose with the reagent of the strip The meter measures the current calculates the blood gluc...

Страница 8: ... contents on your product box They can be purchased separately Blood glucose meter Owner s manual Protective wallet carrying bag Quick start user guide Warranty card Lancing device with clear cap for Alternative Site Testing If any items are missing from your kit or opened prior to use please contact local customer services or place of purchase for assistance NOTE ...

Страница 9: ...Ejector Eject the used strip by pushing up this button Test Slot Insert test strip here to turn the meter on for testing SET Button Enter and confirm the meter settings M Button Enter the meter memory and silence a reminder alarm Front Side Back ...

Страница 10: ...10 Display Screen Blood drop symbol Test strip symbol Code Test result Date Time Day average Low battery symbol Memory symbol Ketone warning Control solution mode Measurement unit Face Low High symbol ...

Страница 11: ...IAVUE Test Strips Using other test strips with this meter can produce inaccurate results NOTE Confirmation window Confirm if enough blood has been applied to the absorbent hole of the test strip Test Strip Handle Hold this part to insert the test strip into the slot Contact Bars Insert this end of the test strip into the test slot Absorbent Hole Apply a drop of blood here and the blood will be dra...

Страница 12: ...ge the meter battery you should check and update these settings Make sure you com plete the steps below and have your desired settings saved Entering the Setting Mode Start with the meter off no test strip inserted Press and firmly hold SET for 3 seconds until the meter turns on ...

Страница 13: ...e date With the year flashing press until the correct year appears Press Set With the month flashing press until the correct month appears Press Set With the day flashing press until the correct day appears Press Set ...

Страница 14: ...14 2 Setting the time With the hour flashing press until the correct hour appears Press Set With the minute flashing press until the correct minute ap pears Press Set ...

Страница 15: ...ss Set to set the hour When the hour is flashing press to add an hour Press Set to confirm and go to minutes press to add one minute Hold longer to add faster Press Set to confirm and go to the next alarm setting If you do not want to set an alarm press Set to skip this step If you want to turn off an alarm find the alarm number by pressing Set in the setting mode press M to change from ON to OFF ...

Страница 16: ...EL and a flashing symbol on the display press and select No to keep the results in memory then press Set to skip To delete all the results press twice dEL and are displayed on the meter which indicates that all data stored is deleted ...

Страница 17: ... when you first receive the meter at least once a week to routinely check the meter and test strips you begin using a new vial of test strips you suspect the meter or test strips are not working properly your blood glucose test results are not consistent with how you feel or if you think the results are not ac curate practicing the testing process or you have dropped or think you may have damaged ...

Страница 18: ...trol solution test With CTL displayed the meter will not store your test result in memory If you press the M button again the CTL will disappear and this test is no longer a control solution test When doing the control solution test you have to mark it so that the test result will not be stored in the memory Failure to do so will mix up the blood glucose test results with the control solution test...

Страница 19: ...n squeeze out another drop and place it on the tip of the vial cap Hold the meter to move the absorbent hole of the test strip to touch the drop Once the confirmation window fills completely the meter will begin counting down To avoid contaminating the control solution do not directly apply control solution onto a strip ...

Страница 20: ...t Out of range results If you continue to have test results fall outside the range printed on the test strip vial the meter and strips may not be working properly Do NOT test your blood Contact the local customer service or place of purchase for help The control solution range printed on the test strip vial is for control solution use only It is not a recom mended range for your blood glucose leve...

Страница 21: ...BLOOD SAMPLE Cap Cocking Control Release Button Lancet Holder Ejector Arrow Depth Indicator Adjustable Tip A Clear Cap If your lancing device differs from the one shown here please refer to the manufacturer s manual to ensure proper usage Pull off the cap of the lancing device 1 ...

Страница 22: ...is fully secured 3 Twist the protective disk off the lancet 4 Replace the cap by aligning the arrow on the cap with the release button 5 Select the depth of penetration by turning the adjustable tip in either direc tion so that the arrow on the cap points to the desired depth ...

Страница 23: ...k until it clicks You will see a color change inside the release button when it is ready If it does not click the device may have been cocked when the lancet was inserted The lancing device is now ready for use Set aside for later use ...

Страница 24: ...ng Select the puncture site either at fingertips or another body parts please see section Alternative Site Test ing AST on how to select the appropriate sites Clean the puncture site using cotton moistened with 70 alcohol and let it air dry Rub the puncture site for about 20 seconds before penetration Use a clear cap included in the kit while setting up the lancing device Please follow the suggest...

Страница 25: ...obvious veins because of excessive bleeding Blood from sites other than the fingertip Choose a different spot each time you test Repeated punctures at the same spot may cause soreness and calluses Please consult your health care professional before you begin AST It is recommended that you discard the first drop of blood as it might contain tissue fluid which may affect the test result NOTE ...

Страница 26: ...ith results equivalent to fingertip testing What is the advantage Fingertips feel pain more readily because they are full of nerve endings recep tors At other body sites since nerve endings are not so condensed you will not feel as much pain as on the fingertips When to use AST Food medication illness stress and exercise can affect blood glucose levels Capillary blood at the fingertip reflects the...

Страница 27: ...an 2 hours since the last meal Two hours or more after taking insulin Two hours or more after exercise Do NOT use AST if You think your blood glucose is low You are unaware of hypoglycemia You are testing for hyperglycemia Your AST results do not match the way you feel Your routine glucose results often fluctuate ...

Страница 28: ... preset 2 Obtain a Blood Sample Use the pre set lancing device to puncture the desired site After penetra tion discard the first drop of blood with a clean cotton swab Gently squeeze the punctured area to obtain another drop of blood Be careful NOT to smear the blood sample The volume of blood sample must be at least 0 7 microliter μL of volume actual size ...

Страница 29: ...to the test strip within 195 seconds the meter will automatically turn off You must remove and reinsert the test strip to start a new test The confirmation window should be filled with blood before the meter begins to count down NEVER try to add more blood to the test strip after the drop of blood has moved away Discard the used test strip and retest with a new one If you have trouble filling the ...

Страница 30: ... strip and remove the lancet To eject the test strip point the strip at a disposal container for sharp items The meter will switch itself off automatically after the test strip is ejected Always follow the instructions in the lancing device insert when removing the lancet The used lancet and test strip may be biohazards Please dis card them carefully according to your local regulations WARNING ...

Страница 31: ...R MEMORY Reviewing Test Results 1 Press and release will appear on the display Press again and the first reading you see is the last blood glucose result along with date time and the measurement mode 2 Press the button to recall the test results stored in the meter each time you press 3 Exit the meter memory After the last test results press M again and the meter will be turned off ...

Страница 32: ...ress and release When appears on the display keep pressing for 3 seconds until the flashing appears Release and then your 7 day average result measured in general mode will appear on the display 2 Press to review 14 21 28 60 and 90 day average results ...

Страница 33: ...emory keep pressing for 5 seconds or leave it without any action for 195 seconds The meter will switch off automatically Control solution results are NOT included in the day average If using the meter for the first time displays when you recall the test results or review the average result It indicates that there is no test result in the memory NOTE ...

Страница 34: ...ces or the place of purchase for assistance 1 Obtaining the required cable and installing the software To download the Health Care Software System please visit the website http www DIAVUE com 2 Connecting to a personal computer Connect the cable to a USB port on your computer With the meter switched off connect the other end of the interface USB cable to the meter data port PC will appear on the m...

Страница 35: ...he instructions provided with the software Results will be transmitted with date and time Remove the cable and the meter will automatically switch off While the meter is connecting to the PC it will be unable to per form a blood glucose test WARNING ...

Страница 36: ...hange the batteries 2 The symbol appears with E b Error and low The power is not enough to do a test Please change the batteries immediately MAINTENANCE Battery Your meter comes with one 3V CR2032 lithium battery Low Battery Signal The meter will display one of the messages below to alert you when the meter power is getting low ...

Страница 37: ...you will hear a beep afterwards 3 Replacing the batteries does not affect the test results stored in the memory As with all small batteries these batteries should be kept away from small children If swallowed promptly seek medical assistance Batteries might leak chemicals if unused for a long time Remove the batteries if you are not going to use the device for an extended period i e 3 months or mo...

Страница 38: ... with a cloth moistened with tap water or a mild cleaning agent then dry 1 the device with a soft dry cloth Do NOT rinse with water Do NOT use organic solvents to clean the meter 2 Meter Storage Storage conditions 20 C to 60 C 4 F to140 F below 95 relative humidity Always store or transport the meter in its original storage case Avoid dropping and heavy impact Avoid direct sunlight and high humidi...

Страница 39: ...tightly Touch the test strip with clean and dry hands Use each test strip immediately after removing it from the vial Write the opening date on the vial label when you first opened it Discard remaining test strips after 3 months Do not use test strips beyond the expiry date This may cause inaccurate results Do not bend cut or alter a test strip in any way Keep the strip vial away from children sin...

Страница 40: ...3 months It is recommended that the control solution test be done at room temperature 20 C to 25 C 68 F to77 F Make sure your control solution meter and test strips are at this specified temperature range before test ing Shake the vial before use discard the first drop of control solution and wipe off the dispenser tip to ensure a pure sample and an accurate result Store the control solution tight...

Страница 41: ...ircumstances SYSTEM TROUBLESHOOTING MESSAGE WHAT IT MEANS Appears when your result is below measurement limit which is less than 20 mg dL 1 1 mmol L Appears when your result is between 20 69 mg dL 1 1 and 3 8 mmol L It indicates the result is below reference range These symbols indicate hypoglycemia low blood glucose You should seek medical assistance immedi ately Appears when your result is in th...

Страница 42: ...han reference range Appears when your result is equal to or higher than 240 mg dL 13 3 mmol L This indicates the possibility of ketone accumula tion for type 1 diabetes Please seek medical assistance imme diately Appears when your result is higher than the limit of measurement which is higher than 600 mg dL 33 3mmol L Result Readings ...

Страница 43: ...teries immediately Test strip has been used Please replace Appears when a used test strip is inserted Repeat with a new test strip Room temperature is out of range Thus unable to measure Appears when ambient temperature is above system operation range System operation range is 10 C to 40 C 50 F to 104 F Repeat the test after the meter and test strip are in the above temperature range ...

Страница 44: ...ow system operation range System operation range is 10 C to 40 C 50 F to 104 F Repeat the test after the meter and test strip are in the above temperature range Checking internal calibra tion data available Problem with the meter Repeat the test with a new test strip If the meter still does not work please contact the customer service for as sistance ...

Страница 45: ...bars end first and facing up Defective meter or test strips Please contact customer services POSSIBLE CAUSE WHAT TO DO Insufficient blood sample Repeat the test using a new test strip with larger volume of blood sample Defective test strip Repeat the test with a new test strip Sample applied after automatic switch off 2 minutes after last user action Repeat the test with a new test strip Apply sam...

Страница 46: ...Shake the control solution vigor ously and repeat the test again Expired or contaminated control solution Check the expiry date of the control solution Control solution that is too warm or too cold Control solution meter and test strips should be at room tempera ture 20 C 25 C 68 F 77 F before testing Defective test strip Repeat the test with a new test strip Meter malfunction Please contact custo...

Страница 47: ...adjust your treatment plan to gain better control of your diabetes Time of day Normal plasma glucose range for people without diabetes mg dL Fasting and before meal Less than 100 mg dL 5 6 mmol L 2 hours after meals Less than 140 mg dL 7 8 mmol L Source American Diabetes Association 2008 Clinical Practice Recommendations Diabetes Care 31 Supplement 1 S1 108 Please work with your doctor to determin...

Страница 48: ...etween meter and laboratory results follow the guidelines below Before going to the lab Perform a control solution test to make sure that the meter is working properly Fast for at least eight hours before doing comparison tests if possible Take your meter with you to the lab While staying at the lab Make sure that the samples for both tests are taken and tested within 15 minutes of each other Wash...

Страница 49: ...than blood drawn from a vein venous sample used for a lab test 3 Therefore it is best to fast for eight hours before doing comparison tests Factors such as the amount of red blood cells in the blood a high or low hematocrit or the loss of body fluid dehydration may also cause a meter result to be different from a laboratory result References 2 Surwit R S and Feinglos M N Diabetes Forecast 1988 Apr...

Страница 50: ...50 SYMBOL INFORMATION In vitro diagnostic medical device Consult instruction for use Symbol Referent Do not reuse Keep away from sunlight Keep dry Temperature limitation Use by Batch code ...

Страница 51: ... Manufacturer Serial number Caution consult accompanying documents Biological risks Authorized representative in the CE mark European Community Do not use if package is damaged Use within 3 months after opening 3 M 0843 ...

Страница 52: ...sample loading detection Auto reaction time count down Auto shutdown after 195 seconds of idleness Temperature Warning Operating condition 10 C to 40 C 50 F to 104 F below 85 R H no condensing Storage Transportation condition 20 C to 60 C 4 F to 140 F 95 R H Measurement units mg dL Measurement range 20 to 600mg dL 1 1 to 33 3mmol L This device has been tested to meet the electrical and safety requ...

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