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Lifescan Pocket Scan Blood Glucose Monitor System, Owner'S Booklet

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VI

TABLE OF CONTENTS

GETTING STARTED

The Complete PocketScan™ Blood
Glucose Monitoring System

1

PocketScan™ Blood Glucose Meter 2

PocketScan™ Test Strips

4

BEFORE TESTING

Checking the Display

6

Coding the Meter

6

Checking the System with
PocketScan™ Control Solution

9

TESTING YOUR BLOOD

15

Getting a Drop of Blood

16

Step-by-Step Test Procedure

18

Special Messages

20

UK PocketScan OB  10/3/00  4:16 PM  Page VI

Summary of Contents for Pocket Scan Blood Glucose Monitor System

Page 1: ...n com LifeScan UK A Division of Ortho Clinical Diagnostics Enterprise House Station Road Loudwater High Wycombe Buckinghamshire HP10 9UF United Kingdom Registered in England 2549777 Registered office Mandeville House 62 The Broadway Amersham Buckinghamshire England HP7 OHJ LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 UK PocketScan OB Cover 10 3 00 4 10 PM Page 1 ...

Page 2: ...o Clinical Diagnostics 1 rue Camille Desmoulins 92130 Issy les Moulineaux France Blood Glucose Meter EMC Directive 89 336 EEC Blood sampler MDD Directive 93 42 EEC Class I Lancets 0120 MDD Directive 93 42 EEC Class IIa Produced by Gainor Medical 2205 Hwy 42 North McDonough GA 30253 USA LifeScan Inc 1000 Gibraltar Drive Milpitas CA 95035 USA LifeScan Customer Care FreePhone UK 0800 121200 Republic ...

Page 3: ...Owner s Booklet C O M P A C T B L O O D G L U C O S E M O N I T O R I N G S Y S T E M UK PocketScan OB 10 3 00 4 16 PM Page I ...

Page 4: ...P and Beaser R S Joslin Diabetes Manual Philadelphia Lea and Febiger 1989 138 Times of Day Important Phone Numbers Meter Serial No ___________ _ __ _ __ LifeScan Customer Care FreePhone number UK 0800 121200 Republic of Ireland 1800 535676 ___________ ______________ _______________________ Healthcare Professional Pharmacist ___________ ______________ _______________________ Diabetes Specialist Nur...

Page 5: ...testing Blood glucose monitoring plays an important role in controlling your diabetes A long term study of diabetes showed that keeping blood glucose levels close to normal can reduce the risk of complications by up to 60 The results you get with the PocketScan System can help you and your healthcare professional monitor and adjust your treatment plan to gain better control of your diabetes A Warr...

Page 6: ...llary whole blood samples It should not be used for the diagnosis of diabetes or for the testing of newborns CAUTION Before using any product to test your blood sugar blood glu cose read all instructions and practice the test Do all quality control checks as directed and consult with a diabetes healthcare professional UK PocketScan OB 10 3 00 4 16 PM Page IV ...

Page 7: ...r above 13 3 mmol L 240 mg dL and do not have symptoms first repeat the test If you have symptoms or continue to get results that fall below 3 3 mmol L 60 mg dL or above 13 3 mmol L 240 mg dL follow the treatment advice of your healthcare professional If you are experiencing symptoms that are not consistent with your blood glucose test results AND you have followed all instructions described in th...

Page 8: ...can Blood Glucose Meter 2 PocketScan Test Strips 4 BEFORE TESTING Checking the Display 6 Coding the Meter 6 Checking the System with PocketScan Control Solution 9 TESTING YOUR BLOOD 15 Getting a Drop of Blood 16 Step by Step Test Procedure 18 Special Messages 20 UK PocketScan OB 10 3 00 4 16 PM Page VI ...

Page 9: ... FOR YOUR METER Maintenance 26 Batteries 26 DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE 28 SPECIFICATIONS 37 CHANGING METER SETTINGS Changing the Date 38 Changing the Time 40 Changing the Unit of Measurement 41 GUARANTEE 42 TEST SUMMARY 43 UK PocketScan OB 10 3 00 4 16 PM Page VII ...

Page 10: ...VIII UK PocketScan OB 10 3 00 4 17 PM Page VIII ...

Page 11: ...m to produce accurate blood glu cose test results Use only PocketScan Test Strips and PocketScan Control Solution with the PocketScan Blood Glucose Meter Your PocketScan System includes PocketScan Meter PocketScan Test Strips PocketScan Control Solution Penlet II Automatic Blood Sampler Sterile Lancets Owner s Booklet Sporty Carrying Case Quick Reference Guide Warranty Registration Card Record Boo...

Page 12: ...ayed here The large easy to read display is where you read the symbols and simple messages that guide you through the test M BUTTON The M Mode button is used to set up the meter enter the memory mode and turn the meter on and off UK PocketScan OB 10 3 00 4 17 PM Page 2 ...

Page 13: ... will turn on automatically when you insert a test strip C BUTTON The C Change button is used to change the date and time code number and unit of measurement as well as to indicate control solution tests and to review test results while in the memory mode UK PocketScan OB 10 3 00 4 17 PM Page 3 ...

Page 14: ...o matically draws the required quantity of blood into the reaction cell in which the reaction takes place The PocketScan Test Strip consists of the following parts Target Area This is where you apply a small drop of blood The required amount of blood is then automatically drawn into the reaction cell Contact Bars This end of the test strip is inserted into the meter UK PocketScan OB 10 3 00 4 17 P...

Page 15: ...rom the package Write the discard date on the vial label when you open it Discard PocketScan Test Strips and the vial three months after first opening Apply only PocketScan Control Solution or a blood sample to the target area Applying other substances to the target area will cause inaccurate results Do not use test strips beyond the expiration date printed on the package since they may cause inac...

Page 16: ...operly Coding the Meter Code numbers are used to calibrate the PocketScan Test Strips with the PocketScan Meter for accurate results You must code the meter before using it for the first time and then every time you change to another vial of PocketScan Test Strips Check that the code number on the meter display matches the code number on the test strip vial BEFORE TESTING CAUTION If the code numbe...

Page 17: ...l appear on the display for three seconds STEP 2 Match the Code Numbers Compare the code number on the meter display with the code number on the test strip vial If the two code numbers match you may begin testing If they do not match follow Step 3 When you first use the meter three dashes will appear showing that there is no code stored in the memory Example Example UK PocketScan OB 10 3 00 4 17 P...

Page 18: ...will increase by one To move faster simply press and hold the C button After you have selected the correct code number it will flash for three sec onds and then appear solid for three sec onds Then the symbol will appear indicating that the PocketScan System is ready for testing Example UK PocketScan OB 10 3 00 4 17 PM Page 8 ...

Page 19: ... PocketScan Control Solution contains a known amount of glucose that reacts with PocketScan Test Strips Compare your control solution test results with the expect ed range printed on the test strip vial label Control solution should be used to Practice the test procedure Make sure your meter and test strips are working together properly Ensure you are performing the test cor rectly For in vitro di...

Page 20: ...When you begin using a new vial of test strips At least once a week Whenever you suspect that the meter or test strips are not working properly When your blood glucose test results are not consistent with how you feel or when you think your results are not accurate If you drop the meter The control solution test is similar to a blood test except that you use PocketScan Control Solution instead of ...

Page 21: ...opening Record the dis card date date opened plus three months on the control solution vial Discard after three months Store the control solution tightly closed at room temperature below 30 C 86 F Do not refrigerate CAUTION The control solution range printed on the test strip vial is for PocketScan Control Solution only It is used to test meter and test strip performance It is not a recommended ra...

Page 22: ...ate and time Then code 12 example is followed by the symbol Be sure the code number on the display matches the code number on the test strip vial If the code numbers do not match code the meter correctly When the symbol appears on the dis play press and hold the C button until ctl appears With the ctl sign on the display the meter will mark your next test in memory as a control solution test Note ...

Page 23: ...ond drop to the white target area of the test strip STEP 3 Result Appears in 15 Seconds The meter will count down from 15 to 1 second and the control solution test result will appear Compare the result with the range printed on the test strip vial The result should fall within this range Note Every time you perform a control solution test you must mark the test with the ctl sign so that the test w...

Page 24: ...ool Failure to discard the first drop of con trol solution Improper coding of the meter Test strip deterioration Meter malfunction CAUTION If you continue to get control solution test results that fall outside of the range printed on the vial the system may not be working properly Do not use the system to test your blood if you continue to get test results that fall outside of the range If you are...

Page 25: ...ection carefully before using Make sure you have all the items needed to test PocketScan Meter PocketScan Test Strips Penlet II Automatic Blood Sampler Sterile Lancet TESTING YOUR BLOOD UK PocketScan OB 10 3 00 4 17 PM Page 15 ...

Page 26: ... Pull out the sliding barrel until it clicks If CAUTION Use a new sterile lancet every time you test To avoid contamination never use a lancet that has been used by someone else If you share a Penlet II automatic blood sampler with another person each person should use a new sterile lancet and a new or properly desinfected cap Do not use lancet if protected disk has been removed or damaged Dispose...

Page 27: ...obtaining enough blood STEP 4 Lance Your Finger Hold the PENLET II Sampler firmly against the side of your finger Press the release button If necessary squeeze your finger gently to obtain a drop of blood STEP 5 Remove the Lancet Remove the cap Grasp the two prongs near the release button and pull back on the sliding barrel The used lancet will drop out Discard it in a container for sharp objects ...

Page 28: ...l turn on automati cally All segments will appear briefly on the display followed by the date and time Then code 12 example and the sym bol will appear Make sure the code num ber on the display matches the code num ber on the vial of PocketScan Test Strips you are using If the code numbers do not match code the meter Note You cannot perform a blood glucose test until you have set up the meter comp...

Page 29: ...mple within two min utes the meter will turn itself off You must remove the test strip and insert it back into the meter to restart the test STEP 3 Accurate Results in Just 15 Seconds Your blood glucose test result will appear after the meter counts down from 15 to 1 second Blood glucose test results are automatically stored in the meter memory Turn the meter off by removing the test strip Record ...

Page 30: ...are profes sional If your blood glucose test result is above 33 3 mmol L 600 mg dL hi will appear on the meter display This indi cates severe hyperglycemia high blood glucose You should seek immediate medical assistance When your blood glucose test result is between 13 3 and 33 3 mmol L 240 to 600 mg dL ketones will appear on the meter display This message does not mean that the system detected ke...

Page 31: ...the last 150 tests in the memory The 14 day average appears first it is calculated from the blood glucose results obtained during the last 14 days It also indicates how many blood glucose tests have been performed within this period e g 64n 64 tests in the last 14 days When using the meter for the first time 14 DAY AVG will appear showing that there are no test results in memory USING THE METER ME...

Page 32: ...s in order When the memory is full the oldest result is dropped as the newest is added To move through the tests in memory more quickly press and hold the C button Control solution test results will appear on the display with ctl mem Note You can enter the memory mode from the test mode After com pleting a blood glucose or control solution test and while the test result is still on the display pre...

Page 33: ...035 Made in Germany Data Downloading Using a PocketScan Adapter you can easily transfer your test results to a LifeScan Interface Cable connected to a serial port on your personal computer The test result data can then be viewed using any PocketScan Meter compatible software To obtain information on the PocketScan Adapter call the LifeScan Customer Care Freephone 0800 121200 for further details UK...

Page 34: ...est to make sure the meter is working properly It is best to fast for at least eight hours before doing comparison tests Take your meter with you to the lab While at the lab Make sure that the samples for both tests the meter test and the lab test are taken and tested within 15 minutes of each other Wash your hands before obtaining a blood sample Never use your meter with blood that has been colle...

Page 35: ...on tests Factors such as the amount of red blood cells in the blood a high or low Haematocrit or the loss of body fluid severe dehydration may also cause a meter result to be different from a laboratory result Plasma Serum The PocketScan System is calibrated to plasma serum which allows you to compare directly PocketScan meter results with your lab results References 1 Clarke W L et al Diabetes Ca...

Page 36: ...nstrument Please handle it with care Batteries Your PocketScan Meter comes with two 1 5 V 357 silver oxide batteries that are already installed Each pair of batteries will provide you with enough power to perform about 1 000 tests The meter will alert you when the power is get ting low by displaying two different messages 1 The symbol appears on the display when the meter is turned on and all the ...

Page 37: ...king sure the positive side of each battery is facing up in the meter 3 Place the three tabs of the battery cover into the three slots in the meter Push the battery cover upward in the direction of its imprint ed arrow to align the sides of the battery cover with the meter Slide the battery cover down into place until it clicks Note Replacing the batteries does not affect the meter s memory previo...

Page 38: ...llowing is a summary of all display mes sages and symbols In the event of a prob lem refer to the information under ACTION DISPLAY MESSAGES AND PROBLEM SOLVING GUIDE UK PocketScan OB 10 3 00 4 17 PM Page 28 ...

Page 39: ...forfurtheraction Missingseg mentscanleadtothewronginterpreta tionofthedisplayedtestresult This message appears immedi ately after the system check if your meter has not been coded See Coding the Meter pages 10 12 This is the code number stored in the meter Make sure that this code num ber matches the code number on the vial of the test strips you are using The system is ready to accept a blood sam...

Page 40: ...Fifteen second count down The meter is verifying the test strip and is calculating the result At the end of the count down the meter will display the test result No action required A blood glucose test result in mg dL No action required A blood glucose test result in mmol L No action required UK PocketScan OB 10 3 00 4 17 PM Page 30 ...

Page 41: ...3 3 mmol L 600 mg dL This message indicates very high blood sugar You should recheck your glucose level and if hi call your doctor immedi ately Your blood glucose level is lower than 1 1 mmol L 20 mg dL This message indicates very low blood sugar You should treat this condition according to the recommendations of your healthcare professional A blood glucose test result stored in the memory No acti...

Page 42: ...ow to perform a test Repeat the test in a warmer place 15 35 C 59 95 F Allow 20 minutes for the instru ment to equilibrate to the new ambient temperature before retesting Either the ambient temperature or the meter s temperature was too high to perform a test Repeat the test in a cooler place 15 35 C 59 95 F Allow 20 minutes for the instru ment to equilibrate to the new ambient temperature before ...

Page 43: ...sage could be caused by a used test strip or indicates a temporary or permanent electronics problem Repeat the test with a new test strip If the error message appears again contact LifeScan Customer Care FreePhone at UK 0800 121200 Republic of Ireland 1800 535676 Error message that indicates that the blood sample was applied before appeared on the display Repeat the test with a new test strip Appl...

Page 44: ...ode number on the meter display matches the code number on the test strip vial Check test strip for damage Code meter or retest as necessary Repeat the test If the error mes sage appears again contact LifeScan Customer Care FreePhone at UK 0800 121200 Republic of Ireland 1800 535676 Average of the last 14 days 64 tests were performed within this period No action required UK PocketScan OB 10 3 00 4...

Page 45: ...rs Test results will still be accu rate but replace the batteries as soon as possible The battery sign appears on the display by itself The power of the batteries is too low to run a test Replace the batteries at once The meter will not operate This is the first time you are using the meter The unit of mea surement is not yet selected Select the appropriate unit of measurement UK PocketScan OB 10 ...

Page 46: ...ct bars end first and facing up d Defective Meter Call LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 PROBABLE CAUSE WHAT TO DO a Insufficient blood sample Repeat the test with a new test strip and a larger sample b Defective test strip Repeat the test with a new test strip c Sample applied after automatic Repeat the test with a new test strip shutoff two minutes a...

Page 47: ...attery Life 1 000 tests or about one year at three tests per day Glucose Units Either mmol L or mg dL Calibration Plasma Serum Memory 150 blood glucose and control solution tests Automatic Shutoff Two minutes after last user action Size 7 92 cm x 5 71 cm x 1 90 cm Weight 45 3 grams with batteries Operating Ranges Temperature15 35 C 59 95 F Relative Humidity 10 90 Hematocrit 30 55 SPECIFICA TIONS U...

Page 48: ...C button to advance one year To move faster hold the C button down With the correct year on the display press the M button and the month and day will appear on the display with the month segment flashing STEP 2 Set the Day Press and release the C button until the correct day appears To move faster hold the C button down With the correct day on the display press the M button and the hour and minute...

Page 49: ...and release the C button until the correct month appears To move faster hold the C button down With the correct month on the display press the M button and the day segment will start flashing UK PocketScan OB 10 3 00 4 17 PM Page 39 ...

Page 50: ... Press and release the C button to advance one minute To move faster hold the C button down With the correct minute on the display press the M button and the current unit of measurement setting will appear Note Your PocketScan Meter displays a 14 day average which you can access from the meter memory This average is calculated from results obtained during the 14 days preceding the current date and...

Page 51: ... the unit of mea surement you are choosing appears on the display STEP 2 Exit the Setting Mode After choosing your unit of measurement press the M button to turn off the meter The meter will display all test results in this unit of measurement Note You must move through the year day month hour minutes and unit of measurement to turn off the meter and exit the setting mode The unit of measurement m...

Page 52: ...l be free of defects in material and workmanship for a period of three years This guarantee is valid from the date of purchase The guar antee extends only to the original purchas er and is not transferable GUARANTEE UK PocketScan OB 10 3 00 4 17 PM Page 42 ...

Page 53: ...he target area Hold your fin ger against the test strip until the meter begins to count down 3 Accurate results in just 15 seconds This summary is intended only for quick reference and not as a substitute for the PocketScan Owner s Booklet TEST SUMMARY Example UK PocketScan OB 10 3 00 4 17 PM Page 43 ...

Page 54: ...44 Notes UK PocketScan OB 10 3 00 4 17 PM Page 44 ...

Page 55: ...o Clinical Diagnostics 1 rue Camille Desmoulins 92130 Issy les Moulineaux France Blood Glucose Meter EMC Directive 89 336 EEC Blood sampler MDD Directive 93 42 EEC Class I Lancets 0120 MDD Directive 93 42 EEC Class IIa Produced by Gainor Medical 2205 Hwy 42 North McDonough GA 30253 USA LifeScan Inc 1000 Gibraltar Drive Milpitas CA 95035 USA LifeScan Customer Care FreePhone UK 0800 121200 Republic ...

Page 56: ...n com LifeScan UK A Division of Ortho Clinical Diagnostics Enterprise House Station Road Loudwater High Wycombe Buckinghamshire HP10 9UF United Kingdom Registered in England 2549777 Registered office Mandeville House 62 The Broadway Amersham Buckinghamshire England HP7 OHJ LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 UK PocketScan OB Cover 10 3 00 4 10 PM Page 1 ...

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