LifescanメーカーPocket Scan Blood Glucose Monitor Systemの使用説明書/サービス説明書
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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 .
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 .
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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 .
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 .
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.
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.
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.
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.
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.
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 .
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.
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 .
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.
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.
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.
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 .
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.
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).
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.
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 .
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 .
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 .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 .
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 .
デバイスLifescan Pocket Scan Blood Glucose Monitor Systemの購入後に(又は購入する前であっても)重要なポイントは、説明書をよく読むことです。その単純な理由はいくつかあります:
Lifescan Pocket Scan Blood Glucose Monitor Systemをまだ購入していないなら、この製品の基本情報を理解する良い機会です。まずは上にある説明書の最初のページをご覧ください。そこにはLifescan Pocket Scan Blood Glucose Monitor Systemの技術情報の概要が記載されているはずです。デバイスがあなたのニーズを満たすかどうかは、ここで確認しましょう。Lifescan Pocket Scan Blood Glucose Monitor Systemの取扱説明書の次のページをよく読むことにより、製品の全機能やその取り扱いに関する情報を知ることができます。Lifescan Pocket Scan Blood Glucose Monitor Systemで得られた情報は、きっとあなたの購入の決断を手助けしてくれることでしょう。
Lifescan Pocket Scan Blood Glucose Monitor Systemを既にお持ちだが、まだ読んでいない場合は、上記の理由によりそれを行うべきです。そうすることにより機能を適切に使用しているか、又はLifescan Pocket Scan Blood Glucose Monitor Systemの不適切な取り扱いによりその寿命を短くする危険を犯していないかどうかを知ることができます。
ですが、ユーザガイドが果たす重要な役割の一つは、Lifescan Pocket Scan Blood Glucose Monitor Systemに関する問題の解決を支援することです。そこにはほとんどの場合、トラブルシューティング、すなわちLifescan Pocket Scan Blood Glucose Monitor Systemデバイスで最もよく起こりうる故障・不良とそれらの対処法についてのアドバイスを見つけることができるはずです。たとえ問題を解決できなかった場合でも、説明書にはカスタマー・サービスセンター又は最寄りのサービスセンターへの問い合わせ先等、次の対処法についての指示があるはずです。