LifescanメーカーSureStepの使用説明書/サービス説明書
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LifeScan Customer Care Line/Ligne InfoSoins : Monday–Friday 9 AM –8 PM Eastern T ime, 6 AM –5 PM Pacific Time Du lundi au vendredi de 9 h à 20 h, heure de l’Est et de 6 h à 17 h, heure du Pacifique Canada 1 800 663-5521 U.S.A./É.-U. 1 800 227-8862 Distributed by/Distribué par : LifeScan Canada Ltd.
COMPLETE BLOOD GLUCOSE MONITORING SYSTEM Owner’ s Booklet LSC-99-005 CanSS(RR)OB/Eng 1/5/00 4:02 PM Page T3.
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The SureStep ® System is intended for use outside the body (in vitro diagnostic use). It should be used only for testing purposes and only with fresh whole blood samples.
Important phone numbers: Meter Serial Number _____________ LifeScan Customer Care Line: CANADA 1 800 663-5521 U.S.A. 1 800 227-8862 Healthcare Professional ________________________ Pharmacist ________.
CAUTION: Before using any product to test your blood glucose (blood sugar), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional.
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LEARNING THE SYSTEM 1 SureStep ® Blood Glucose Meter 3 SureStep ® Test Strips 4 Display Symbols 6 CODING THE METER Three Easy Steps to Coding 10 CHECKING THE SYSTEM SureStep ® Glucose Control Solut.
UNDERSTANDING YOUR RESULTS O verview 36 Comparing Meter and Laboratory Results 37 Expected Test Results (Target Range) 38 Testing Tips to Ensure Accuracy 40 Health Conditions Causing Out-of-Range Resu.
CHANGING METER SETTINGS (Set-Up Mode) 54 Entering Set-Up Mode 55 Setting the Time and Date 55 Display of Last Result 58 Unit of Measurement (mmol/L or mg/dL) 59 Beep Signals 60 14- and 30-Day Test Ave.
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The SureStep ® Diabetes Blood Glucose Monitoring System is the next advance in the self-monitoring of blood glucose. The SureStep ® System is for people with diabetes who need to check the level of sugar (glucose) in their blood.
LEARNING 2 Colour Chart Gluc ose Shake before Not Intended Discard 3 mo Discard date: Lot N o. Exp. Date © LIFESCAN IN Extra Space for Diabetes Supplies LSC-99-005 CanSS(RR)OB/Eng 1/5/00 4:02 PM Page.
DISPLAY Shows your test results and symbols that guide you through the test. SureStep ® Blood Glucose Meter POWER BUTTON (Blue) Turns the meter on and off, accesses the memory, and navi- gates through the set-up mode. BATTERY COMPARTMENT Holds two AAA alkaline batteries.
4 LEARNING SureStep ® T est Strips When blood is applied to the pink test square, it is absorbed and a chemical reaction takes place. A blue colour forms in the confirmation dot on the back of the test strip and is read by the meter to determine the blood glucose level; the darker the colour , the higher the blood glucose level.
5 IMPORT ANT TEST STRIP INFORMA TION ■ Contact with air , moisture, and light can cause false results. Keep test strips sealed in the original moisture-resistant, light-protected package and store in a cool, dry place not above 30°C (86°F). Do not refrigerate, place in direct heat or sunlight, or leave bottle open.
6 LEARNING Display Symbols The SureStep ® Blood Glucose Meter uses symbols to guide you through a test and to help you determine if something is wrong with your test strip or meter . T o check that all display symbols are working, press and hold down the blue power button.
7 Meter Memory Result. Y our SureStep ® Meter stores up to 150 blood glucose or control solution test results with their times and dates in its memory . Every time you turn the meter on, it will automati- cally recall and display your last (most recent) result with date.
8 LEARNING Apply Blood Sample to Pink T est Square. Push the T est Strip, Pink Side Up, Firmly into the T est Strip Holder Until It Stops. If you fail to completely insert the test strip, the test may start. However , you may receive an inaccurate low result.
HI mmol/L. In virtually all cases above 27.8 mmol/L (500 mg /dL), the meter reads “ . ” When proper procedures are followed, a reading of “” means very high blood glucose (severe hyperglycemia). In extremely rare circumstances, the meter will read “” instead of “” above 27.
10 Code numbers are used to calibrate the SureStep ® T est Strip with the SureStep ® Meter for accurate results. Y ou must code the meter before using it for the first time. Y ou must check the code every time you change to another package of test strips.
11 Next, the meter code will appear for a few seconds. Step 2: Check the Code Numbers. The code number on the test strip package will range from 1 to 21. If the number on the display matches the code number on the SureStep ® T est Strip package, begin testing.
The SureStep ® System does not require a check strip. The meter performs an automatic check every time you turn it on. SureStep ® Glucose Control Solution Control solution is used instead of blood to tell you that the SureStep ® Blood Glucose Meter and SureStep ® T est Strips are working together properly .
13 IMPORT ANT CONTROL SOLUTION TEST INFORMA TION ■ Use only SureStep ® Glucose Control Solution. ■ Check the expiration date. Do not use if expired. ■ Record the discard date on the control solution vial. Discard the vial three months after first opening it.
Follow the test procedure, using SureStep ® Glucose Control Solution instead of blood. Before T esting, Check the Code. After turning the meter on, the last result appears, followed by the CODE symbol and number . If the code on the meter does not match the code on the test strip package, press the green C button until the codes match.
15 Step 2: Check Confirmation Dot. Check to see that the confirmation dot on the back of the test strip has turned completely blue to ensure you have applied enough control solution.
The control solution result appears, on average, in 30 seconds. (Example) Note: Do not use the Colour Chart to verify control solution tests. Step 4: Mark the T est Result as a Control Solution T est.
17 If you accidentally mark a blood glucose test result as a control solution test result, just press the green C button to delete the marker . Record control solution tests in your logbook by placing a C next to the result to indicate a control solution test.
18 Control Solution Range If test results fall outside the expect- ed range, repeat the test. Results that fall outside the expected range may indicate the system is not working properly .
19 Detailed T est Procedure Choose a clean, dry work surface. Make sure you have all the items needed to test. TESTING TESTING YOUR BLOOD Release Button Ejection /Cocking Control Depth Adjustment Knob.
20 TESTING Getting a Drop of Blood. IMPORT ANT : Getting an adequate drop of blood is one of the most important steps in getting an accurate result. Step 1: Insert a Lancet into the Penlet ® Plus Adjustable Blood Sampler . Remove the Penlet ® Plus Cap by twisting it counterclockwise.
While the lancet is in the Penlet ® Plus Sampler , twist off the protective disk. Make two full turns to ensure that the lancet separates from the protective disk. Replace the Penlet ® Plus Cap. T urn the cap clockwise until it is snug but not overly tight.
TESTING Adjust the puncture depth setting if necessary . T wist the knob counter- clockwise toward the smaller bumps for a shallower puncture. T wist the knob clockwise toward the larger bumps for a deeper puncture. Step 2: Cock the Penlet ® Plus Sampler .
23 Step 3: W ash Y our Hands. Use warm, soapy water . Rinse and dry hands thoroughly . T o increase blood flow to your fingertips, massage the hand from the wrist to the fingertip two or three times without touching the puncture site. Step 4: Lance Y our Finger .
TESTING Gently massage your finger to obtain the required blood volume. Proceed with your blood glucose test. Step 5: Remove the Lancet. Remove the cap.
25 Optional: T o replace the protective disk on the lancet, place the disk on a hard surface and push the exposed tip into the protective disk. Always use caution when removing the lancet. Point the lancet down and away from you. Push forward on the ejection/cocking control and eject the lancet directly into a container for sharp objects.
How to T est Y our Blood. Press the blue power button. Y our last test result will appear . Next, the code number appears. It must match the code number on the SureStep ® T est Strip package. If it does not match, change the meter code number following the instruc- tions on pages 10 and 11.
These symbols will alternate on the display: The meter is ready for a test. Y ou have two minutes to insert the test strip before the meter automatically turns off. Step 1: Apply Blood to the T est Strip. Apply a drop of blood to the center of the pink test square.
28 Y ou can apply blood to the pink test square in one of two ways. 1) T urn the test strip over and dab the pink test square to the finger . Y ou can touch the test strip. The pink test square will quickly absorb the blood and the confirmation dot will begin changing colour .
29 Y ou have applied too much blood to the test strip if the entire white pad is soaked. Y ou must begin the test with a new test strip to avoid false results from too much blood. Step 2: Check the Confirmation Dot. After a few seconds, look at the confirmation dot on the back of the test strip.
30 If any white patches or white streaks appear on the confirmation dot, you have not applied enough blood for an accurate test. Y ou must start the test over with a new test strip. Caution: If you do not insert the test strip properly , you may get an inaccurate result.
31 beep when the meter displays your result. Results appear , on average, in 30 seconds. The result is displayed first with the time and then with the date (time and date will alternate). See pages 55 – 58 to learn how to set the time and date. The meter displays results from 0 to 27.
32 System enables you to more directly compare meter results with lab results. See pages 37 and 38 to learn how to compare meter and lab results. TESTING IMPORT ANT : When proper procedures are followed, the meter will dis- play “” in virtually all cases when your result is above 27 .
33 Record your test results in your LifeScan logbook. The logbook allows you to keep a record of your test results, along with information on your meals and medication. Press the blue power button to turn off the SureStep ® Blood Glucose Meter . (T o save energy , the meter automatically turns off three minutes after it displays your test result.
34 Optional Colour Chart A Colour Chart is included with each package of SureStep ® T est Strips. It is useful as an additional check that your meter and test strips are working properly . The Colour Chart is NOT a replacement for a SureStep ® Meter test.
35 colours, your blood glucose level is between the values printed next to the two colours. This comparison will give you a rough estimate of your blood glucose level. The Colour Chart is to be used as an additional check to confirm a meter read- ing.
36 Overview Long-T erm Diabetes Findings. In 1993 the National Institutes of Health concluded an exten- sive long-term study of people with T ype 1 diabetes.
Frequency of T esting. How often you need to test your blood glucose will vary according to your age, the type of diabetes you have, the medications you are taking, and your physical and emotional health. Y our health- care professional will guide you.
Blood glucose levels can change significantly over short periods, especially if you have recently eaten, exercised, taken medication, or experienced stress. 3 In addition, if you have eaten recently , the blood glucose level from a fingerstick can be up to 3.
39 RESULTS GLUCOSE RANGES FOR PEOPLE WITHOUT YOUR TARGET DIABETES, 5 mmol/L RANGES, 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.
40 RESULTS T esting T ips to Ensure Accuracy If you have a test result that falls outside of your target range and you cannot link it to diet, exercise, med- ication, or stress, repeat the test. If the result is similar and still outside of your range, try these troubleshoot- ing steps: Before T esting : ■ W ash your hands.
41 ing the test strip confirmation dot to be certain it turned com- pletely blue. ■ Make sure you did not apply too much blood to the test strip. Y ou have applied too much blood if there is no white visible on the white pad.
RESULTS “Do I have symptoms of high blood glucose (hyperglycemia): fatigue, dry mouth and skin, increased thirst or hunger , blurry vision, increased urination, rapid deep breathing, or a fruity smell to the breath?” “What have I eaten?” “How much have I exercised?” “Am I ill (common cold, flu, etc.
43 Recommendations for Better Diabetes Control ■ Follow the advice of your health- care professional. ■ Follow the exercise and meal plans recommended by your healthcare professional. ■ T ake insulin or diabetes medication at your scheduled times.
44 MEMORY The SureStep ® Blood Glucose Meter is pre-set to display your last test result automatically when you turn on the meter . The meter stores your 150 most recent blood glucose or control solution test results with alternating date and time in its memory .
Recalling All Results in Meter Memory T o access the meter memory , press the blue power button and hold down for five seconds. When the display flashes, release the blue power button. Y ou are now in memory mode. First, the 14-day average will appear .
If a previous test resulted in an error condition, the error will be stored in the memory with the date. Note: A “ ” result will be included in your 14- and 30-day averages as 27.8 mmol/L. The time and date must be reset every time the batteries are replaced.
Y our SureStep ® Blood Glucose Meter is easy to maintain. However , to keep it in good operating condi- tion, follow these simple rules: General Care ■ Keep your meter dry and avoid exposing it to extremes in temper- ature. Do not store your meter or test strips in a car or refrigerator .
48 Always clean your meter when this symbol appears: If you are concerned that your test results do not compare with how you feel, clean the meter and do a control solution test to check if it is working properly . Clean the meter using these easy steps: Step 1: Remove the T est Strip Holder .
49 Make sure you thoroughly wi pe the grey area on the inside cover . W ash both sides of test strip holder base; carefully clean around the hole. Dry the test strip holder completely with a soft cloth or lint-free tissue. Step 3: Clean the Lens Area and Contact Points.
Step 4: Replace the T est Strip Holder . Slide the test strip holder into the meter , press down, and push forward at the test strip insertion point until you hear a click. Make sure the test strip holder is firmly in place. M ake sure it does not extend beyond the m eter .
51 MAINTENANCE If this symbol appears after clean- ing the meter , check to see if you inserted the test strip holder com- pletely and securely . The test strip holder may be out of position.
52 flashing, the batteries are now dead and the meter will not operate. ( Y ou will not be able to do a test.) Y ou should replace both batteries immediately with new AAA alkaline batteries. Do not use rechargeable batteries. Note: Low batteries, dead batteries, and battery removal will not affect the te st re su lts stored in the memory .
53 Step 2: Remove the Old Batteries. Use your fingers or gently tap the meter on the palm of your hand. Never tap the meter against a hard surface. Step 3: Insert New Batteries. Insert two new AAA alkaline batteries, matching the + end of each battery with the + signs inside the meter .
The SureStep ® Meter has been pre-set to meet the needs of most users. In addition to setting the time and date, there are six features you can change. Be sure you want to change these settings before entering the set-up mode to avoid having meter settings that do not meet your needs.
Entering Set-Up Mode 1. Make sure the meter is off. 2. Press and hold down the green C button. 3. Press and release the blue power button while holding the green C button. 4. Release the green C button. Each setting flashes on the display until you press the blue power button to move to the next feature.
56 test re su lts will not be affected if you do not set the clock to the cor- rect time.) The time and date must be reset every time the batteries are replaced. Setting the T ime. T o set the time, enter the set-up mode. The display will show the time with the hour flashing.
57 Setting the Y ear . W ith the year on the display , press and release the green C button to advance one year . T o move faster , hold the green C button down. W ith the correct year on the display , press the blue power button and the month and day will appear (month/ day format is default) on the display with the month segment flashing.
58 Setting the Day . Press and release the green C button until the correct day appears. T o move faster , hold the green C button down. W ith the correct day on the display , press the blue power button and the display of last result setting will appear .
59 SETTINGS Unit of Measurement The meter is pre-set to display test results in millimoles per litre (mmol/L). Y ou have the option to select milligrams per decilitre (mg/dL), the unit of measurement used in the United States. The mmol/L results include a decimal point, but mg/ dL results do not.
Beep Signals The SureStep ® Blood Glucose Meter uses beeping tones to signal various steps in the meter procedures. However , these tones do not indicate that the procedures are being per- formed correctly . The meter is pre-set to emit three different beep signals: 1.
61 SETTINGS Y ou will hear a three-tone beep when is displayed. Press the blue power button to move to the 14- and 30-day test averages setting. 14- and 30-Day T est A verages The meter is pre-set to display 14-day and 30-day averages of your blood glucose test results in memory mode.
T ime Format The meter is pre-set to display the time in the 12-hour AM/PM format. An alternative 24-hour time format is available. Press the green C button if you wish to change the setting. Press the blue power button to move to the date format setting.
Exiting the Set-Up Mode Y ou may exit the set-up mode at any time by simply pressing the blue power button and holding it down until the display is blank.
64 MESSAGES When any of the following symbols or error messages appear , there may be a problem with the meter , test strip, or the way you are doing the procedure. These messages help to identify certain problems but do not appear in all cases when a prob- lem has occurred.
SYMBOL MESSAGE WHAT TO DO 2. Reinsert the test strip, tip first, with the pink side facing up. 2. The test strip was inserted incorrectly , or 1. Remove the test strip and then reinsert after this symbol appears.
SYMBOL MESSAGE WHAT TO DO Replace the batteries (see pages 51 – 53). If the symbol is constant, the batteries are low . If the symbol is flashing, the bat- teries are dead. 3. Reinsert test strip slowly . 3. The test strip was inserted too quickly .
ERROR POSSIBLE CAUSE WHAT TO DO 2. Repeat the test with a new test strip. Apply a larger drop of blood to the pink test square and verify that the confirmation dot on the back of the test strip has turned completely blue . 2. Not enough blood is on the test strip, or 1.
ERROR POSSIBLE CAUSE WHAT TO DO 4 . Do a visual check of the colour of the confirmation dot versus the Colour Chart on the test strip package. A colour that matches or is darker than the 19.4 mmol/L (350 mg /dL) colour on the chart indicates a high blood glucose level.
ERROR POSSIBLE CAUSE WHAT TO DO 2. Check the expiration date on your test strip package. Do not store test strips outside of the original bottle. Do not alter test strips. 2. The test strip has been altered, exposed to air , or has passed its expiration date.
ERROR POSSIBLE CAUSE WHAT TO DO Note: If more than two minutes have passed since you applied blood to the test strip, repeat the test with a new test strip. 2. Clean meter contact points. 2. The meter contact points are dirty . 1. Do not remove the test strip until the meter displays the result.
ERROR POSSIBLE CAUSE WHAT TO DO 2. Slide the test strip holder into the meter until it is completely inserted. 2. The test strip holder is not fully in place, or 1. Clean; refer to pages 47 – 51. 1. The meter test strip holder , lens area, and contact points are dirty , or Allow the meter to warm or cool slowly before performing another test.
ERROR POSSIBLE CAUSE WHAT TO DO T urn meter on. Before testing, check that the code on your meter matches the code on your test strip package. If continues, call the LifeScan Customer Care Line at 1 800 663-5521 (U.S.A. 1 800 227-8862). A possible failure has occurred in the meter .
Performance Characteristics Power Supply: T wo AAA alkaline batteries. Battery Life: Approximately 18 months when doing two tests a day . Result Range: 0 – 27.8 mmol/L (0 – 500 mg/dL). Higher results are displayed as “ . ” Display: Liquid crystal.
Guarantee and W arranty 30-Day Money-Back Guarantee. If you are not fully satisfied with the SureStep ® System, a full refund may be obtained by calling a LifeScan Customer Services Representative at 1 800 663-5521 (Canada) within 30 days of pur- chase.
Please complete the W arranty Registration Card and mail it to LifeScan. The SureStep ® Meter has a full six-year warranty from the original date of purchase.
REGULA TOR Y INFORMA TION The SureStep ® Blood Glucose Meter complies with the following standards: ■ CAN/CSA C22.2 No. 601.1 - M90 “ Medical Electrical Equipment - Part 1: General Requirements for Safety ” (Complies with UL 2601-1). ■ CAN/CSA C108.
QUICK REFERENCE CODING THE METER 1 Press blue power button. 2 Meter automatically displays last test result with date. AM PM 3 Code number is automatically displayed. 4 Press green C button until code number on meter matches code number on test strip package.
78 QUICK REFERENCE BLOOD AP PLICA TION How you can be sure that you have applied the right amount of blood: Pink test square is where you apply a drop of blood. White pad absorbs the excess blood that may extend beyond the pink test square. Do not apply blood directly onto the white pad.
LifeScan Customer Care Line/Ligne InfoSoins : Monday–Friday 9 AM –8 PM Eastern T ime, 6 AM –5 PM Pacific Time Du lundi au vendredi de 9 h à 20 h, heure de l’Est et de 6 h à 17 h, heure du Pacifique Canada 1 800 663-5521 U.S.A./É.-U. 1 800 227-8862 Distributed by/Distribué par : LifeScan Canada Ltd.
デバイスLifescan SureStep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 SureStep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 SureStep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 SureStep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 SureStep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 SureStep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 SureStep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 SureStep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 SureStep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。
