Lifescan Blood Glucose Monitor System manual

Owner’ s Booklet COMPACT BLOOD GLUCOSE MONITORING SYSTEM Printed in U.S.A. Patent(s) Pending © 1999 LIFESCAN INC. AW*05023101A* Visit the LifeScan website at http://www .lifescan.com LifeScan, UK A Division of Ortho-Clinical Diagnostics Enterprise House Station Road Loudwater , High Wycombe Buckinghamshire HP10 9UF United Kingdom Registered in E[...]

The enclosed LifeScan Blood Glucose Meter , as an electromedical device, has been thoroughly tested and found to comply with the essential requirements of the Electro Magnetic Compatibility Directive (EMC, 89/336/EEC), 1998. 1998 LifeScan Regulatory Affairs Europe Div . d’Ortho-Clinical Diagnostics 1, rue Camille Desmoulins 92130 Issy les Mouline[...]

Owner’ s Booklet COMPACT BLOOD GLUCOSE MONITORING SYSTEM UK PocketScan OB 10/3/00 4:16 PM Page I[...]

Glucose Ranges for People Without Diabetes (mmol/L) Y our T arget Ranges (mmol/L) Before breakfast Before lunch or dinner 1 hour after meals 2 hours after meals Between 2 and 4 AM 3.9-5.8 3.9-6.1 Less than 8.9 Less than 6.7 Greater than 3.9 Source: Krall, L.P ., and Beaser , R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 138. T[...]

III Dear PocketScan™ System Owner: Y ou have chosen one of the best blood glucose monitoring systems available today . Y our PocketScan System will provide you with the accurate and fast blood glucose test results you need for better man- agement of your diabetes. Y ou just need to follow a few simple steps. This owner’ s booklet contains every[...]

IV The PocketScan™ System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing glucose (sugar) and only with fresh capillary 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- c[...]

V Important Information • Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehy- dration, consult a healthcare professional immediately . • T est results below 3.3 mmol/L (60 mg/dL) mean low blood glu- cose (hypoglycemia). T est results greater than 13.3 mmol/L (240 mg/dL) mea[...]

VI T ABLE OF CONTENTS GETTING ST ARTED The Complete PocketScan™ Blood Glucose Monitoring System 1 PocketScan™ Blood Glucose Meter 2 PocketScan™ T est 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 T est Pr[...]

VII USING THE METER MEMORY 21 COMP ARING METER AND LABORA TORY RESUL TS 24 CARING FOR YOUR METER Maintenance 26 Batteries 26 DISPLA Y MESSAGES AND PROBLEM-SOL VING GUIDE 28 SPECIFICA TIONS 37 CHANGING METER SETTINGS Changing the Date 38 Changing the T ime 40 Changing the Unit of Measurement 41 GUARANTEE 42 TEST SUMMARY 43 UK PocketScan OB 10/3/00 4[...]

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

1 The Complete PocketScan™ Blood Glucose Monitoring System The PocketScan Blood Glucose Monitoring System consists of three main products: the PocketScan™ Blood Glucose Meter , PocketScan™ T est Strips, and PocketScan™ Control Solution. These products have been designed, tested, and proven to work togeth- er as a system to produce accurate [...]

2 PocketScan ™ Blood Glucose Meter DISPLA Y Y our test results are displayed 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[...]

3 TEST POR T The test port is where you insert the PocketScan™ T est Strip for testing. The meter 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 [...]

4 PocketScan ™ T est Strips The PocketScan™ Blood Glucose Monitoring System measures the amount of sugar (glucose) in whole blood. Blood is applied to the target area of the PocketScan T est Strip. The test strip auto- matically draws the required quantity of blood into the reaction cell in which the reaction takes place. The PocketScan T est S[...]

5 Important T est Strip Information • Store the test strip package in a cool, dry place below 30°C (86°F). Keep away from direct sunlight and heat. Do not refrigerate. • Store your test strips in their original vial only; do not transfer them to a new bottle or any other container . • After removing a PocketScan™ T est Strip from the vial[...]

6 Checking the Display Each time you insert a test strip into the PocketScan™ Meter or turn the meter on, all segments of the display will appear briefly . This tells you that the system is per- forming several self-checks and allows you to confirm that all display segments are working properly . Coding the Meter Code numbers are used to calibrat[...]

7 STEP 1 Enter the Code Mode. Start with the meter turned off. Insert a PocketScan™ T est Strip to turn on the meter . All segments of the display will appear followed by the date and time. Next, the code number will appear on the display for three seconds. STEP 2 Match the Code Numbers. Compare the code number on the meter display with the code [...]

8 STEP 3 Code the Meter . Use the C button to select the correct code. Each time you press and release the C but- ton, the number will increase by one. T o 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 w[...]

9 Checking the System with PocketScan™ Control Solution PocketScan Control Solution is used to check that the meter and test strips are working together as a system and that you are performing the test correctly . It is very important that you do this simple check routinely to make sure you get accurate results. PocketScan Control Solution contai[...]

10 Before you use the PocketScan™ Meter to test your blood for the first time, practice the procedure using control solution. When you can do three tests in a row that are within the expected range, you are ready to test your blood. Do a control solution test: • When you begin using a new vial of test strips. • At least once a week. • Whene[...]

11 Important Control Solution T est Information • Use only PocketScan™ Control Solution. • Check the expiration date on the control solution vial. Do not use if expired. • Shake the vial and discard the first drop of PocketScan Control Solution. • Use only for three months after first opening. Record the dis- card date (date opened plus t[...]

12 How to do a control solution test: STEP 1 Insert T est Strip. Insert a test strip, contact bars end first and facing up, into the test port. (Contact bars must be inserted all the way into the meter or you may get an inaccurate test result.) The meter will turn on automati- cally . All segments will appear briefly on the display followed by the [...]

13 Normal Glucose Control Solution (Example) If you decide not to perform a control solution test, the “ ctl ” sign will disappear if you press the C button again. STEP 2 Apply Control Solution. Shake the control solution vial well. Remove the cap. Squeeze the vial and dis- card the first drop. Apply the second drop to the white target area of [...]

14 Comparing control solution results If test results fall outside the range printed on the test strip vial, repeat the test. Out- of-range results may be caused by one or more of the following: • Error in performing the test. • Failure to shake the control solution vial vigorously . • Expired or contaminated control solu- tion. • Control s[...]

15 Be sure to read this section carefully before using. Make sure you have all the items needed to test: • PocketScan™ Meter • PocketScan™ T est Strips • Penlet ® II Automatic Blood Sampler • Sterile Lancet TESTING YOUR BLOOD UK PocketScan OB 10/3/00 4:17 PM Page 15[...]

16 Getting a Drop of Blood STEP 1 Insert a Lancet in the PENLET II Automatic Blood Sampler . Remove the PENLET II Cap by pulling it straight off. Insert the lancet into the lancet holder . Hold the lancet firmly , and gently twist and pull off the protective disk. Replace the cap. STEP 2 Cock the PENLET II Sampler . Pull out the sliding barrel unti[...]

17 it does not click, the PENLET II Sampler may have been cocked when the lancet was inserted. STEP 3 Wash Y our Hands. Use warm, soapy water . Rinse and dry them thoroughly . Hanging your arm down for 20 seconds will help if you have diffi- culty obtaining enough blood. STEP 4 Lance Y our Finger . Hold the PENLET II Sampler firmly against the side[...]

18 Step-by-Step T est Procedure STEP 1 Insert T est Strip. Insert the test strip, contact bars end first and facing up, into the test port. (Contact bars must be inserted all the way into the meter or you may get an inaccurate test result.) The meter will turn on automati- cally . All segments will appear briefly on the display followed by the date[...]

19 STEP 2 Apply Sample. Obtain a drop of blood from your finger using the PENLET II Automatic Blood Sampler . When the symbol appears on the display , touch a small drop of blood to the white target area of the test strip. Hold your finger against the test strip until the meter begins to count down. (If you do not apply a blood sample within two mi[...]

20 Special Messages The PocketScan™ Meter displays results between 1.1 and 33.3 mmol/L (20 to 600 mg/dL). If your test result is lower than 1.1 mmol/L (20 mg/dL), “ lo ” will appear on the meter display . This indicates severe hypoglycemia (low blood glucose). Y ou should immediately treat hypoglycemia as recommended by your healthcare profes[...]

21 Y our PocketScan™ Meter stores the 150 most recent blood glucose and control solution test results with date and time in its memory . It also provides you with a 14-day average of your blood glucose test results. Y ou can review the test results in memory with these easy steps: STEP 1 Enter the Memory Mode. With the meter turned off, press the[...]

22 STEP 2 Recall T est Results. After three seconds, the 14-day average will be replaced by the most recent test result with date and time. Press the C but- ton once and the next most recent test result will appear . Each time you press and release the C button, the meter will recall up to your last 150 test results in order . When the memory is fu[...]

23 STEP 3 Exit the Memory Mode. Press the M button to turn off the meter . Note: When using the meter for the first time, “ mem--- ” will appear , showing that there are no test results in memory . (Example) ADAPTER © LIFESCAN, INC. 1999 Milpitas, CA 95035 Made in Germany Data Downloading Using a PocketScan™ Adapter , you can easily transfer[...]

24 The blood glucose test result you obtain from your meter may be different from your laboratory result due to normal variation. The two results should, however , be within 20% of each other . 1 T o make an accurate comparison between meter and laboratory results, follow the guidelines below . Before you go to the lab: • Perform a control soluti[...]

25 Y ou may still have a variation from the result because blood glucose levels can change sig- nificantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress. 2 In addi- tion, if you have eaten recently , the blood glucose level from a fingerstick can be up to 3.9 mmol/L (70 mg/dL) higher t[...]

26 Maintenance Y our PocketScan™ Meter does not require spe- cial maintenance. As no blood or control solu- tion comes in contact with the meter , there is no special cleaning required. T ake care to avoid get- ting dirt, dust, blood, control solution, or water inside the meter through the test port. Store the meter in its carrying case after eac[...]

27 2. The symbol appears on the display by itself. This means that the batteries will not provide enough power for a test. Y ou must change the batteries. T o replace the batteries, make sure that the meter is turned off. T urn the meter over and locate the battery compartment. 1. Press down with both thumbs on each side of the battery cover’ s i[...]

28 Following is a summary of all display mes- sages and symbols. In the event of a prob- lem, refer to the information under ACTION. DISPLA Y MESSAGES AND PROBLEM- SOL VING GUIDE UK PocketScan OB 10/3/00 4:17 PM Page 28[...]

29 MESSAGE WHA T IT MEANS ACTION System check. Appears upon insertion of a test strip or whenever the meter is turned on. V erifies that all segments are present on the display . If segments are missing, contact LifeScan Customer Care FreePhone, UK: 0800 12100, Republic of Ireland: 1800 535676, for further action. Missing seg- ments can lead to the[...]

30 MESSAGE WHA T IT MEANS ACTION The system is ready to accept a control solution test sample. Y ou may now apply the control solution. 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[...]

31 MESSAGE WHA T IT MEANS ACTION A blood glucose test result with a suggestion to check your ketone levels. Y ou may want to check your ketone levels. Act according to instructions of your healthcare professional. Y our blood glucose level is higher than 33.3 mmol/L (600 mg/dL). This message indicates very high blood sugar . You should recheck your[...]

32 MESSAGE WHA T IT MEANS ACTION A control solution test result stored in the memory . No action required. There is no test result stored in this place in the memory . No action required. Either the ambient temperature or the meter’ s temperature was too low to perform a test. Repeat the test in a warmer place 15-35°C (59-95°F). Allow 20 minute[...]

33 MESSAGE WHA T IT MEANS ACTION Error message that indicates that there is a problem with the meter . Review the instructions and try again with a new test strip. If the problem persists, call LifeScan Customer Care FreePhone, UK: 0800 121200, Republic of Ireland: 1800 535676, for help. Error message could be caused by a used test strip or indicat[...]

34 MESSAGE WHA T IT MEANS ACTION Error message that indicates that there may be a problem with the test strip, e.g., the test strip may have been damaged, removed during testing, or inserted improperly . Check that the code number on the meter display matches the code number on the test strip vial. Check test strip for damage. Code meter or retest [...]

35 MESSAGE WHA T IT MEANS ACTION The battery sign appears on the display with the unit of mea- surement. The power of the batteries is getting low . You can complete about 50 more tests from the time this symbol first appears. T est results will still be accu- rate, but replace the batteries as soon as possible. The battery sign appears on the disp[...]

36 If the meter does not display a message after inserting a test strip: If the test does not start after applying the sample: PROBABLE CAUSE WHA T TO DO a. Batteries exhausted. Replace the batteries. b. Batteries incorrectly Check that the batteries are correctly installed or absent. installed with the positive “+” side up. c. T est strip inse[...]

37 Result Range: 1.1 to 33.3 mmol/L (20 to 600 mg/dL) Sample: Fresh capillary whole blood Sample Size: 2.5 microliters T est T ime: 15 seconds Assay Method: Glucose oxidase biosensor Power Source: T wo replaceable 1.5 V #357 silver oxide batteries Battery Life: 1,000 tests, or about one year at three tests per day Glucose Units: Either mmol/L or mg[...]

CHANGING METER SETTINGS 38 Changing the Date T o change the date, you must first enter the setting mode. Start with the meter off. Then press and hold the M button for three sec- onds. The meter is now in the setting mode. STEP 1 Set the Y ear . The year setting will appear first. Press and release the C button to advance one year . T o move faster[...]

39 STEP 3 Set the Month. Press and release the C button until the correct month appears. T o 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[...]

40 Changing the Time Before setting the time, you must first set the date. STEP 1 Set the Hour . Press and release the C button to advance one hour . T o move faster , hold the C but- ton down. With the correct hour (with AM or PM) on the display , press the M button and the minutes setting will start flashing. STEP 2 Set the Minutes. Press and rel[...]

41 Changing the Unit of Measurement The PocketScan™ Meter can display test results in millimoles per liter (mmol/L) or in milligrams per deciliter (mg/dL). Before setting the unit of measurement, you must first set the date and time. STEP 1 Select mmol/L or mg/dL. Press the C button until the unit of mea- surement you are choosing appears on the [...]

42 The makers guarantee that the PocketScan™ Meter shall 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[...]

43 1. Insert test strip. Meter turns on automatically . 2. Apply sample. T ouch a small drop of blood to the 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[...]

44 Notes UK PocketScan OB 10/3/00 4:17 PM Page 44[...]

The enclosed LifeScan Blood Glucose Meter , as an electromedical device, has been thoroughly tested and found to comply with the essential requirements of the Electro Magnetic Compatibility Directive (EMC, 89/336/EEC), 1998. 1998 LifeScan Regulatory Affairs Europe Div . d’Ortho-Clinical Diagnostics 1, rue Camille Desmoulins 92130 Issy les Mouline[...]

Owner’ s Booklet COMPACT BLOOD GLUCOSE MONITORING SYSTEM Printed in U.S.A. Patent(s) Pending © 1999 LIFESCAN INC. AW*05023101A* Visit the LifeScan website at http://www .lifescan.com LifeScan, UK A Division of Ortho-Clinical Diagnostics Enterprise House Station Road Loudwater , High Wycombe Buckinghamshire HP10 9UF United Kingdom Registered in E[...]