UK PocketScan OB Cover 10/3/00 4:10 PM Page 1 Visit the LifeScan website at http://www.lifescan.com LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 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 AW*05023101A* Printed in U.S.A.
UK PocketScan OB Cover 10/3/00 4:10 PM Page 2 LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 LifeScan Inc. 1000 Gibraltar Drive Milpitas, CA 95035 USA LifeScan Regulatory Affairs Europe Div.
UK PocketScan OB 10/3/00 4:16 PM Page I COMPACT BLOOD GLUCOSE MONITORING SYSTEM Owner’s Booklet
UK PocketScan OB 10/3/00 Times of Day 4:16 PM Page II Glucose Ranges for People Without Diabetes (mmol/L) Before breakfast 3.9-5.8 Before lunch or dinner 3.9-6.1 1 hour after meals Less than 8.9 2 hours after meals Less than 6.7 Between 2 and 4 AM Greater than 3.9 Your Target Ranges (mmol/L) Source: Krall, L.P., and Beaser, R.S.: Joslin Diabetes Manual. Philadelphia: Lea and Febiger (1989), 138. Important Phone Numbers: Meter Serial No.
UK PocketScan OB 10/3/00 4:16 PM Page III Dear PocketScan™ System Owner: You have chosen one of the best blood glucose monitoring systems available today. Your PocketScan System will provide you with the accurate and fast blood glucose test results you need for better management of your diabetes. You just need to follow a few simple steps. This owner’s booklet contains everything you need to know about using the PocketScan System. Read it carefully and thoroughly before you begin testing.
UK PocketScan OB 10/3/00 4:16 PM Page 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 glucose), read all instructions and practice the test.
UK PocketScan OB 10/3/00 4:16 PM Page V Important Information • 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. • Test results below 3.3 mmol/L (60 mg/dL) mean low blood glucose (hypoglycemia). Test results greater than 13.3 mmol/L (240 mg/dL) mean high blood glucose (hyperglycemia). If you get results below 3.3 mmol/L (60 mg/dL) or above 13.
UK PocketScan OB 10/3/00 4:16 PM Page VI TABLE OF CONTENTS GETTING STARTED The Complete PocketScan™ Blood Glucose Monitoring System 1 PocketScan™ Blood Glucose Meter 2 PocketScan™ Test Strips 4 Checking the Display 6 Coding the Meter 6 Checking the System with PocketScan™ Control Solution 9 BEFORE TESTING Getting a Drop of Blood 15 16 Step-by-Step Test Procedure 18 Special Messages 20 TESTING YOUR BLOOD VI
UK PocketScan OB 10/3/00 4:16 PM Page VII USING THE METER MEMORY 21 COMPARING METER AND LABORATORY RESULTS 24 CARING 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 VII
UK PocketScan OB VIII 10/3/00 4:17 PM Page VIII
UK PocketScan OB 10/3/00 4:17 PM Page 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™ Test Strips, and PocketScan™ Control Solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only PocketScan Test Strips and PocketScan Control Solution with the PocketScan Blood Glucose Meter.
UK PocketScan OB 10/3/00 4:17 PM Page 2 PocketScan™ Blood Glucose Meter DISPLAY Your 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 PORT The test port is where you insert the PocketScan™ Test 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 memory mode.
UK PocketScan OB 10/3/00 4:17 PM Page 4 PocketScan™ Test 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 Test Strip. The test strip automatically 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.
UK PocketScan OB 10/3/00 4:17 PM Page 5 Important Test 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™ Test Strip from the vial, replace the vial cap and close it tightly.
UK PocketScan OB BEFORE TESTING 10/3/00 4:17 PM Page 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 performing several self-checks and allows you to confirm that all display segments are working properly. Coding the Meter Code numbers are used to calibrate the PocketScan™ Test Strips with the PocketScan Meter for accurate results.
UK PocketScan OB 10/3/00 4:17 PM Page 7 STEP 1 Enter the Code Mode. Start with the meter turned off. Insert a PocketScan™ Test 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. (Example) 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.
UK PocketScan OB 10/3/00 4:17 PM Page 8 STEP 3 (Example) 8 Code the Meter. Use the C button to select the correct code. Each time you press and release the C button, the number 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 seconds and then appear solid for three seconds. Then the symbol will appear, indicating that the PocketScan™ System is ready for testing.
UK PocketScan OB 10/3/00 4:17 PM Page 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 contains a known amount of glucose that reacts with PocketScan™ Test Strips.
UK PocketScan OB 10/3/00 4:17 PM Page 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. • Whenever you suspect that the meter or test strips are not working properly.
UK PocketScan OB 10/3/00 4:17 PM Page 11 Important Control Solution Test 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 discard date (date opened plus three months) on the control solution vial. Discard after three months.
UK PocketScan OB 10/3/00 4:17 PM Page 12 How to do a control solution test: Note: You cannot perform a control solution test until you have set up the meter completely (see pages 6-9). STEP 1 Insert Test 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 automatically. All segments will appear briefly on the display followed by the date and time.
UK PocketScan OB 10/3/00 4:17 PM Page 13 If you decide not to perform a control solution test, the “ctl” sign will disappear if you press the C button again. Note: Every time you perform a control solution test, you must mark the test with the “ctl” sign so that the test will be distinguished from a blood glucose test in the meter memory. STEP 2 ntrol e Co ucos al Gl Norm ion Solut Apply Control Solution. Shake the control solution vial well. Remove the cap.
UK PocketScan OB 10/3/00 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 unable to resolve the problem, call LifeScan Customer Care FreePhone at UK: 0800 121200, Republic of Ireland: 1800 535676.
UK PocketScan OB 10/3/00 4:17 PM Page 15 Be sure to read this section carefully before using.
UK PocketScan OB 10/3/00 4:17 PM Page 16 Getting a Drop of Blood 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 of the used lancet in an appropriate container for sharp objects.
UK PocketScan OB 10/3/00 4:17 PM Page 17 it does not click, the PENLET II Sampler may have been cocked when the lancet was inserted. STEP 3 Wash Your Hands. Use warm, soapy water. Rinse and dry them thoroughly. Hanging your arm down for 20 seconds will help if you have difficulty 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.
UK PocketScan OB 10/3/00 4:17 PM Page 18 Step-by-Step Test Procedure Note: You cannot perform a blood glucose test until you have set up the meter completely. STEP 1 Insert Test 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 automatically. All segments will appear briefly on the display followed by the date and time.
UK PocketScan OB 10/3/00 4:17 PM Page 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 minutes, the meter will turn itself off.
UK PocketScan OB 10/3/00 4:17 PM Page 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). You should immediately treat hypoglycemia as recommended by your healthcare professional. If your blood glucose test result is above 33.3 mmol/L (600 mg/dL), “hi” will appear on the meter display.
UK PocketScan OB 10/3/00 4:17 PM Page 21 Your 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. You can review the test results in memory with these easy steps: STEP 1 USING THE METER MEMORY Enter the Memory Mode. With the meter turned off, press the M button. The 14-day average will appear, indicating that you are in the memory mode.
UK PocketScan OB 10/3/00 4:17 PM Page 22 Note: You can enter the memory mode from the test mode. After completing a blood glucose or control solution test and while the test result is still on the display, press the M button. This will put the meter into the memory mode. STEP 2 (Example) 22 Recall Test Results. After three seconds, the 14-day average will be replaced by the most recent test result with date and time. Press the C button once and the next most recent test result will appear.
UK PocketScan OB 10/3/00 4:17 PM Page 23 Note: When using the meter for the first time, “mem---” will appear, showing that there are no test results in memory. STEP 3 Exit the Memory Mode. Press the M button to turn off the meter. (Example) Data Downloading ADAPTER Made in Germany © LIFESCAN, INC. 1999 Milpitas, CA 95035 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.
UK PocketScan OB 10/3/00 COMPARING METER AND LABORATORY RESULTS 4:17 PM Page 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 To make an accurate comparison between meter and laboratory results, follow the guidelines below. Before you go to the lab: • Perform a control solution test to make sure the meter is working properly.
UK PocketScan OB 10/3/00 4:17 PM Page 25 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.2 In addition, if you have eaten recently, the blood glucose level from a fingerstick can be up to 3.9 mmol/L (70 mg/dL) higher than blood drawn from a vein (venous sample) used for a lab test.
UK PocketScan OB 10/3/00 CARING FOR YOUR METER 4:17 PM Page 26 Maintenance Your PocketScan™ Meter does not require special maintenance. As no blood or control solution comes in contact with the meter, there is no special cleaning required. Take care to avoid getting dirt, dust, blood, control solution, or water inside the meter through the test port. Store the meter in its carrying case after each use. To clean the outside of the meter, wipe it with a damp cloth and mild detergent.
UK PocketScan OB 10/3/00 4:17 PM Page 27 2. The symbol appears on the display by itself. This means that the batteries will not provide enough power for a test. You must change the batteries. To replace the batteries, make sure that the meter is turned off. Turn the meter over and locate the battery compartment. 1. Press down with both thumbs on each side of the battery cover’s imprinted arrow. Then slide the battery cover away in the direction of the arrow. 2. Remove the old batteries. Insert two 1.
UK PocketScan OB 10/3/00 DISPLAY MESSAGES AND PROBLEMSOLVING GUIDE 28 4:17 PM Page 28 Following is a summary of all display messages and symbols. In the event of a problem, refer to the information under ACTION.
UK PocketScan OB MESSAGE 10/3/00 4:17 PM Page 29 WHAT IT MEANS ACTION System check. Appears upon insertion of a test strip or whenever the meter is turned on. Verifies 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 segments can lead to the wrong interpretation of the displayed test result.
UK PocketScan OB MESSAGE 30 10/3/00 4:17 PM Page 30 WHAT IT MEANS ACTION The system is ready to accept a control solution test sample. You 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 countdown, 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 MESSAGE 10/3/00 4:17 PM Page 31 WHAT IT MEANS ACTION A blood glucose test result with a suggestion to check your ketone levels. You may want to check your ketone levels. Act according to instructions of your healthcare professional. Your blood glucose level is higher than 33.3 mmol/L (600 mg/dL). This message indicates very high blood sugar. You should recheck your glucose level and if hi call your doctor immediately. Your blood glucose level is lower than 1.1 mmol/L (20 mg/dL).
UK PocketScan OB MESSAGE 32 10/3/00 4:17 PM Page 32 WHAT 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 minutes for the instrument to equilibrate to the new ambient temperature before retesting.
UK PocketScan OB MESSAGE 10/3/00 4:17 PM Page 33 WHAT 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 indicates a temporary or permanent electronics problem. Repeat the test with a new test strip.
UK PocketScan OB MESSAGE 34 10/3/00 4:17 PM Page 34 WHAT 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 as necessary. Repeat the test.
UK PocketScan OB MESSAGE 10/3/00 4:17 PM Page 35 WHAT IT MEANS ACTION The battery sign appears on the display with the unit of measurement. The power of the batteries is getting low. You can complete about 50 more tests from the time this symbol first appears. Test results will still be accurate, 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.
UK PocketScan OB 10/3/00 4:17 PM Page 36 If the meter does not display a message after inserting a test strip: PROBABLE CAUSE WHAT TO DO a. Batteries exhausted. Replace the batteries. b. Batteries incorrectly installed or absent. Check that the batteries are correctly installed with the positive “+” side up. c. Test strip inserted upside down or incompletely. Insert the test strip correctly with the contact bars end first and facing up. d. Defective Meter.
UK PocketScan OB 10/3/00 4:17 PM Page 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 Test Time: 15 seconds Assay Method: Glucose oxidase biosensor Power Source: Two replaceable 1.
UK PocketScan OB 10/3/00 CHANGING METER SETTINGS 4:17 PM Page 38 Changing the Date To change the date, you must first enter the setting mode. Start with the meter off. Then press and hold the M button for three seconds. The meter is now in the setting mode. STEP 1 Set the Year. The year setting will appear first. Press and release the C button to advance one year. To move faster, hold the C button down.
UK PocketScan OB 10/3/00 4:17 PM Page 39 STEP 3 Set the Month. Press 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 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. To move faster, hold the C button 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 release the C button to advance one minute. To move faster, hold the C button down.
UK PocketScan OB 10/3/00 4:17 PM Page 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 measurement 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.
UK PocketScan OB 10/3/00 GUARANTEE 42 4:17 PM Page 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 guarantee extends only to the original purchaser and is not transferable.
UK PocketScan OB 10/3/00 4:17 PM Page 43 TEST SUMMARY* 1. Insert test strip. Meter turns on automatically. 2. Apply sample. Touch a small drop of blood to the target area. Hold your finger 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.
UK PocketScan OB Notes 44 10/3/00 4:17 PM Page 44
UK PocketScan OB Cover 10/3/00 4:10 PM Page 2 LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 LifeScan Inc. 1000 Gibraltar Drive Milpitas, CA 95035 USA LifeScan Regulatory Affairs Europe Div.
UK PocketScan OB Cover 10/3/00 4:10 PM Page 1 Visit the LifeScan website at http://www.lifescan.com LifeScan Customer Care FreePhone UK 0800 121200 Republic of Ireland 1800 535676 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 AW*05023101A* Printed in U.S.A.