Instruction/ maintenance manual of the product Basic Blood Glucose Monitoring System Lifescan
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Blood Glucose Monitoring System Bas ic Bas ic Bas ic Simple Proven Accur acy Easy T o Handle Owner's Booklet DCO_06331801A_OTB_OB_US 11/25/03 3:27 PM Page i.
DCO_06331801A_OTB_OB_US 11/25/03 3:27 PM Page ii.
The OneT ouch ® Basic ® Blood Glucose Monitoring System is intended for in vitro diagnostic use for quantitativ e determination of glucose in whole blood a s a n aid in monitoring effectiveness of diabetes management in the home and in clinical settings.
C AUTION: Before using any product to test y our blood glucose (sugar), read all instructions and practice the test. Do all quality control checks as directed and consult with a diabetes healthcare professional.
T ABLE OF CONT ENT S INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PREC AUTIONS AND LIMIT A TIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
www .LifeScan.com TESTING YOUR BL OOD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Abbreviated T est Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SETTING METER OPTION S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Entering and Using the Set-Up Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Clock (Time and Date) .
T AKING C ARE OF YOUR METER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Doing a Daily Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 INTRODUCTION Congratulations! Y ou’v e chosen a very easy-to-use blood glucose monitoring system for home testing. When used pr operly , your OneT ouch ® Basic ® System will give y ou the accurate test results you need, in just a few simple steps.
PREC AUTION S AND LIMIT A TION S The following information will b e useful to you and your healthcare professional when using the OneT ouch ® Basic ® System to monitor y our blood glucose level.
Extremes in hematocrit (the amount of red blood cells in the blood) can affect test results. V ery high hemat ocrits (abov e 55 %) and very low hematocrits ( below 30 %) can cause false results. 1 Abnormally high levels of V itamin C o r other reducing substances will cause false low blood glucose r esults.
GETT ING ST AR T ED The OneT ouch ® Basic ® Blood Glucose Monitoring System c o n sists of three main products: the OneT ouch ® Basic ® Blood Glucose Meter , OneT ouch ® Basic ® , Profile ® , OneT ouch ® I I T est Strips, and OneT ouch ® Normal Control Solution.
The Complete OneT ouch ® Basic ® Blood Glucose Monitoring System ■ OneT ouch ® Basic ® Meter (Batteries installed) ■ Owner’ s Booklet ■ Quick Reference Guide ■ Check Strip ■ OneT ouch .
OneT ouch ® Basic ® Blood Glucose Meter Study this diagr am and become familiar with all the par ts of your OneT ouch ® Basic ® Meter . 6 M Button Test Strip Holder C M Battery Compartment (on bac.
ON/OFF BUTT ON. This button turns the meter on and off. DISPL A Y . The large, easy-to-read display is where you r ead the s im pl e m essages that guide you through testing. Y our test results are display ed here. BA TTERY C OMP AR TMENT . Holds two AA A batteries.
DA T A POR T . Allows you to transfer the information stored in the meter’ s memory to a computer to view , analyze, and print. Please contact th e LifeScan Data Management Line at 1 800 382-7226 for more information about data management software products.
9 IMPOR T ANT TES T STRIP INFORMA TION ■ OneT ouch ® Basic ® , Profile ® , OneT ouch ® II T est Strips can be damaged by heat and light. K eep them sealed in the original vial. Stor e the vial in a cool, dry place below 86 °F ( 30 °C). Do not refrigerate.
OneT ouch ® Normal Control Solution OneT ouch ® Normal Control Solution is an impor tant part of the OneT ouch ® Basic ® System. Use it in two ways: 1 ) to practice the test procedur e, and 2 ) to make sur e that the OneT ouch ® Basic ® Meter and OneT ouch ® Basic ® , Profile ® , OneT ouch ® II T est Strips are working together properly .
BEFORE T ESTING Setting Meter Code Code numbers are used to enable your meter to pro vide consistent measurements. F or this reason, it is impor tant that the code is set correctly .
Step 1 : Press the On/Off Button. When turning meter on, all display symbols will appear . The last test r esult will then appear on the display for a moment.
Step 3 : Code the Meter . While the meter displays code-- , or after the word insert is displayed, press and release the C button; the code number will appear . Continue pr essing the C button until the number on the display matches the code number on the test strip vial.
Checking with the Check Strip A purple and white check strip is included in the carrying case of your OneT ouch ® Basic ® System. Befor e doing a check strip test, make sure the test strip holder , test area, and check strip are clean, dry , and lint-free.
Do a check strip test: ■ At least once each day you test your blood ■ After cleaning the meter ■ Whenever your blood glucose test results are not consistent with ho w you feel, or when you think.
Step 2 : When apply sample Appears, R emo ve the Check Strip fr om the T est Strip Holder . Step 3 : When insert side 2 Appears, T urn the Check Strip Over and Slide It Back into the T est Strip Holder . It should go in notched end first, Side 2 (white side) facing up.
(Example) If these messages appear , repeat the check strip test. If these messages appear again, clean your meter and repeat the test. If you do not obtain an acceptable ( Ao k ) check strip reading,.
■ Do not get blood, alcohol, control solution, or any other fluid (except water) on the check strip. ■ Do not scratch the check strip . ■ Do not leave the check strip in sunlight. ■ If you lose or damage the check strip, call LifeScan Customer Services at 1 800 227-8862 for a free replacement.
19 Do a control solution test: ■ For pr actice, before testing your blood with the OneT ouch ® Basic ® Meter for the first time ■ When you begin using a new vial of test strips ■ At least once.
IMPOR T ANT CONTR OL SOL UT ION TES T INFORMA TION ■ Use only OneT ouch ® Normal Control Solution. ■ Check the expiration date of the control solution. Do not use if expir ed. ■ Record the discar d date on the control solution vial. Discard the vial thr ee months after first opening.
How to do a control solution test: Step 1 : Press On/Off Button. Inser t T est Strip. The code number that appears on the meter display should match the code number on the test strip vial.
Step 2 : Apply Control Solution. Shake the control solution vial well before using. Remo v e the cap and apply a drop of control solution to the middle of the test spot, cov ering it completely . Step 3 : Control Solution R esult Appears in 45 Seconds.
Control solution test results ar e automatically stored with the word contrl . (If you use a logbook, indicate control solution tests by writing “C” after the result.) Control solution results If test results fall outside the range printed on the test strip vial, repeat the test.
24 ■ Meter malfunction ■ Extremes in testing temperatures C AUTION: If your control solution test result falls outside the expected range, the system may not be working properly . Do not use the system to test your blood until you get a test r esult that falls within the expected range.
TES TING YOUR BL OOD Abbreviated T est Pr ocedure Y ou can test your blood by follo wing this 3 -step testing procedur e. M C 25 Step 1 : Press on/off button. Make sure code displayed on meter matches code on test strip vial. If correct, insert strip.
Detailed T est Procedur e Choose a clean, dry work surface. Make sure you hav e all the items needed to test: ■ OneT ouch ® Basic ® Meter ■ OneT ouch ® Basic ® , Profile ® , OneT ouch ® II T.
Getting a Drop of Blood C AUTION: T o reduce the chance of infection: ■ Never share a lancet with another person. ■ Always use a new , sterile lancet. Lancets are for single use only . ■ The OneT ouch ® Penlet ® Plus Sampler should be used by only one person.
28 While the lancet is in the OneT ouch ® Penlet ® Plus Sampler , twist off the pro- tec tive disk. Make two full turns to ensure that the lancet separates fr om the protective disk. Replace the OneT ouch ® Penlet ® Plus Cap. T urn the cap clockwise until it is snug but not ov erly tight.
29 Adjust the puncture depth setting if necessary . T wist the knob counter- clockwise toward the smaller bumps for a shallower punctur e. T wist the knob clockwise toward the lar ger bumps for a deeper puncture. Step 2 : Cock the OneT ouch ® Penlet ® Plus Sampler .
30 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 .
31 Gently massage your finger to obtain the required blood v olume. Pr oceed with your blood glucose test. Step 5 : Remo ve the Lancet. Remo ve the cap .
32 Optional: T o replace the protectiv e disk on the lancet, place the disk on a hard surface and push the exposed tip into the protective disk. Always use caution when r emoving th e lancet. Point the lancet down and away from you. Push forwar d on the ejection/cocking control and eject the lancet directly into a container for sharp objects.
How to T est Y our Blood Step 1 : Pr ess On/Off Button. Make Sure Code Number Displayed on Meter Matches Code Number on T est Strip Vial. Insert T est Strip. Make sure the test strip holder is properly in place. (See page 77 ). T urn your meter on. All display symbols will appear .
Remo ve a test strip from the vial. Replace the vial cap immediately . Do not touch the test spot on the test strip. The test spot should be white or ivory-colored, with no tears or wrinkles. With the meter display showing (Example) slide the test strip into the test strip holder , notched end first, test spot facing up.
appears for a moment. Then appears for five minutes or until you apply blood to the test spot. Obtain a drop of blood from y our finger using the OneT ouch ® Penlet ® Plus Adjustable Blood Sampler . (See page 27 ). Step 2 : Apply Blood Sample. With the test strip in the meter and on the display , apply a drop of blood to the test spot.
Be sure that you: ■ T ouch only the tip of the drop of blood to the test spot. ■ Apply enough blood to form a round, shiny drop that cov ers the test spot completely and stays wet during the entire test. ■ Do not smear blood on the test spot or apply a second drop after the test begins.
Step 3 : Accurate R esults in 45 Seconds. The meter then counts down from 45 to 0 seconds, beeps (if the Beep option is set to ), and displays your result. R emov e the test strip only after the result is displayed. Blood glucose test results are automa ti - cally stored in your meter’ s memory with the time and date they were performed.
Special Messages The meter displays results from 0 to 600 mg/dL. If your blood glucose test result is 60 mg/dL or below , y our meter will beep in a low tone (if the Beep option is set to ) and display a special message: (Example) The message is warning you of low blood sugar (hypoglycemia).
Checking the Amount of Blood on the T est Strip Although the OneT ouch ® Basic ® Meter requires only a small dr op of blood, it is very important that the drop be large enough to cov er the test spot completely . In many cases, the meter can detect if the drop of blood was too small to give an accurate reading.
If the following message appears on the display , your drop of blood was too small, or smeared, or the test strip was not pushed all the way into the test strip holder . Repeat the test with a new test strip and enough blood to cov er the entire test spot.
■ Look at the back of the test strip . Y ou should see a full, dark circle. If there are any white patches or streaks, y ou may have smeared the blood or the drop was too small. In either case, you may hav e a false low r esult. R epeat the test with a new test strip .
COMP ARING METER AND L ABORA T ORY RESUL TS The blood glucose test result you obtain fr om y ou r me t er m ay b e different fr om your laboratory r esult due to normal variation; ho wev er , the two results should be within 20 % of each other . 5 T o make an accurate comparison between meter and laboratory r esults, follow these guidelines.
Comparing the results: ■ When the lab tests your blood, only the serum or plasma por tion is used. Y our OneT ouch ® Basic ® Meter uses only whole blood.
recently , the blood glucose level from a fingerstick can be up to 70 mg/dL higher than blood drawn from a v ein (venous sample) used for a lab test. 7 Therefore it is best to fast for four to eight hours before doing comparison tests.
USING THE METER MEMOR Y Y our OneT ouch ® Basic ® Meter automatically stores up to 75 test records. It stor es blood glucose, check strip, and contr ol solution test results with time and date. When y ou have stored more than 75 r ecords, the oldest record is dr opped from the memory as a new record is added.
If you are using the meter for the v ery first time and have not used it for testing, or if you have used a softwar e program to clear the meter’ s memory , the following message will appear , indic.
SETT ING METER OPTIONS Y ou do not have to enter the set-up mode to test. Howev er , you can customize the v arious option settings of your OneT ouch ® Basic ® Meter to best meet your needs.
The meter will then automatically present the first option screen. The options map will help guide you through the option screens. ■ Use the M button to scroll through the options or mov e within an option. ■ If you want to change an option setting, use the C button.
Clock (Time and Date) The OneT ouch ® Basic ® Meter has an internal clock that will record the time and date of each test you perform. Y our meter has been set to auto- matically record tests in P acific standard time ( P S T ) both when the Clock option is set to and when it is set to .
Once the Clock option is set to , yo u a re ready to set the time. If you do not want to display th e ti me and date, press the C button to turn the Clock option to . Setting the Time Enter the set-up mode and set the Clock option to (see page 47 ). Use the M button to display the current time setting.
the time; the hour and am or pm will flash. Press the C button again to advance the hour to the corr ect setting. Press the M button and the minutes will flash. Use the C button to change the minutes. Pr ess the M button to see the new time setting (the colon will flash).
Y ou may now turn the meter off or press the M button to mo ve to the next option. Beep Prompts The meter is set to pro vide you with audio prompts, or “beeps,” during the test procedure to tell y ou that the meter has performed some function or to aler t you to a special message.
Language The OneT ouch ® Basic ® Meter can display messages in 17 lan-guages: English [ engl . ], Spanish [ espan . ], Fr ench [ franc . ], Italian [ italia ], Hungarian [ magyar ], Dutch [ neder . ], Norwegian [ norsk ], Polish [ polski ], Por tuguese [ port .
Time F ormat The meter can be set to display the time in either a 12 -hour (AM/PM) format or a 24 -hour format. T o change the time format, enter the set-up mode (see page 47 ). Use th e M button to choose the T ime Format option. Press the C button t o change the time format.
Unit of Measure The meter is set to display test r esults in milligrams per deciliter (mg/dL), the standard unit used in the United States. Y ou have the option to change to millimoles per liter (mmol/L), commonly used in Canada and par ts of Eur ope.
T o change the decimal separator , enter the set-up mode (see page 47 ) and select mmol/L as the unit of measure. Use the M button to choose the Decimal Separator option. Make your selection using the C button. Y ou may now press the M button to review or change any of the options you have chosen or pr ess the on/off button to turn the meter off.
SOL VING PROBL EMS The messages that appear on your OneT ouch ® Basic ® Meter display guide you through the testing procedur e, alert you to problems as they occur , and give you information about test results stored in the meter’ s memory .
MESSAGE APPEARS WHEN The meter is turned on and you have not pr eviously coded the meter . This is a reminder that you should v erify that the code displayed on the meter matches the code on the test strip vial before testing. If it does not, reset b y pressing the C button.
MESSAGE APPEARS WHEN The meter is performing internal checks. The meter is ready to receiv e a blood or control solution sample. If performing a check strip test, this is your signal to remo ve the check strip fr om the meter . The meter is counting down from 45 seconds to 0 .
MESSAGE APPEARS WHEN A control solution test has been completed. (If you hav e just performed a blood glucose test, this means that the blood sample was too small and the meter read it as control solution. Repeat the test with a new test strip and a lar ger drop of blood.
MESSAGE APPEARS WHEN Y our blood glucose test result is lo w , 60 mg/dL or below , possibly indicating hypoglycemia. Y ou may need food or some source of glucose. Retest. If the test r esult is still 60 mg/dL or below , call your doctor . Y our blood glucose test result is abo ve 600 mg/dL.
Error Messages When any of these messages appear , there is a problem with the OneT ouch ® Basic ® Meter or the way in which you are performing a test. These messages help to identify cer tain problems but do not appear in all cases when a pr oblem has occurred.
MESSAGE PROBL EM WHA T T O DO battry *Neither dead batteries nor battery remo val hav e an effect on information stored in the memory . Replace the batteries immediately . The meter will not operate.* When this symbol is flashing, the batteries are too low .
MESSAGE PROBL EM WHA T T O DO Repeat the test with a new test strip. W ait for the wor d insert before inserting a test strip. The test strip was inser ted before the word insert appeared on the display . remove strip 1 . Clean the test area and test strip holder according to instructions.
MESSAGE PROBL EM WHA T T O DO 1 . Repeat the test with a new test strip. 2 . Repeat the test with a new test strip. 1 . The test strip mov ed during the test. 2 . The test strip was not inserted correctly . error2 retest Repeat the test with a new test strip.
MESSAGE PROBL EM WHA T T O DO 3 . Repeat the test with a new test strip. 4 . Repeat the test with a new test strip. 5 . Mov e the meter away from the light source. Repeat the test with a new test strip. 6 . R epeat the check strip test. 7 . Call LifeScan Customer Services at 1 800 227-8862 .
MESSAGE PROBL EM WHA T T O DO 1 . Repeat the test with a new test strip and a large, shiny dr op of blood or control solution. 1 . The blood or control solution sample was too small or smeared. not enough blood retest Repeat the test with a new test strip.
MESSAGE PROBL EM WHA T T O DO 1 . Clean test ar ea. See page 75. 1 . If appearing when you turn your meter on, your meter’ s test area may be dirty . not ok 3 . R epeat the test. K eep the meter test area clear . 3 . Y our hand or an object covered the test area while the meter was turned on.
MESSAGE PROBL EM WHA T T O DO 4 . R epeat the test with a new test strip. 4 . If appearing during the test, the strip has been remo ved while the word wait is on the display . 3 . R epeat the test with a new test strip; try not to mov e the meter . 3 .
MESSAGE PROBL EM WHA T T O DO Repeat the check strip test. The last check strip test was outside the acceptable range and an acceptable repeat test was not performed. redo A Clean the meter and check strip if necessary . R epeat the check strip test. The check strip test result is outside the acceptable range (printed on the back of the meter).
MESSAGE PROBL EM WHA T T O DO Use the C button to reset the meter code to match the test strip vial code. Y ou should also check all of your meter option settings to be sure they are correct. (If this con- tinues to happen, there may be a problem with your meter .
T AKING C ARE OF YOUR MET ER Y our OneT ouch ® Basic ® Meter is easy to maintain. These tips will help y ou keep it in good operating condition: ■ K eep the test strip holder and test area clean (see page 73 ). ■ K eep your meter dry and av oid exposing it to extremes in tem- perature or humidity .
Doing a Daily Check Look thr ough the small hole in the test strip holder to make sure there is no lint, dir t, or blood blocking it. If there is anything blocking the hole, or if the test area has dirt, lint, or blood on it, remo ve the test strip holder and clean the test area by follo wing the instructions in the next section.
Step 1 : Remo ve the T est Strip Holder from the Meter . Hold the meter and place your thumbs on the two raised dots on the test strip holder . Press do wn on the raised dots and slide the test strip holder toward you. Remo ve the test strip holder to expose the test area.
Step 2 : Clean the T est Strip Holder . W ash only the test strip holder with soap and water . Clean the underside of the test strip holder . Using a damp cotton swab, clean the small hole from both sides to remo ve any di r t , blood, or lint. Rinse well.
Check the clear , protective coating ov er the test area to make sure it is not scratched or damaged. Rub the test area with a cotton swab or soft cloth dampened with water to remo ve all blood, dirt, or lint from the test area. If necessary , a mild liquid dishwashing detergent mix ed with water may also be used.
Dry the test area with a soft, dry tissue or cloth. Remo ve any lint. Step 4 : Replace the T est Strip Holder . Hook the bottom of the test strip holder onto the square notch on the meter . Press do wn on the raised dots of the test strip holder until it snaps firmly into place.
R eplacing the Batteries The OneT ouch ® Basic ® Meter c o m e s with batteries already installed. When the batteries need t o b e re p l aced, use two AA A, 1 . 5 -volt alkaline batteries. The batteries should last about 18 months when testing up to two ( 2 ) times a day .
been remo ved. After that you may need to reset the time and date. Dead batteries and/or battery remo v al will not erase or change test results, default settings, or codes stored in the meter . T o replace the batteries: 1 . Make sur e the meter is turned off before you r emov e the batteries.
4 . R emov e the battery compartment door . 5 . R emo ve the old batteries by gently slapping the meter against the palm of your hand. Never tap the meter against a hard surface.
6 . Insert the new AA A batteries into the battery compar tment, being sure to align the plus (+) and minus (-) signs correctly . T o replace the battery compartment door , inser t the tab on the top of the door into the slot in the top of the battery compar tment.
82 SPECIFIC A T IONS Po wer Supply: T wo A AA alkaline batteries. Batter y Life: About 18 months when testing up to two ( 2 ) times a day . R esult Range: 0 – 600 mg/dL ( 0 – 33 . 3 mmol/L). Higher v alues are displayed as hi . Display T ype: Liquid crystal.
83 GUARANT EE AND W ARRANT Y 30 -Day Money-Back Guarantee If you are not fully satisfied with the OneT ouch ® Basic ® System, a full r efund may be obtained by calling a LifeScan Customer Services Representative at 1 800 227-8862 within 30 days of purchase.
84 Please complete the warranty service card and mail it to LifeScan. The OneT ouch ® Basic ® Meter has a full three-year warr anty from the original date of purchase.
85 INDEX Batteries, Replacing the . . . . . . . . . . . . . . . . . . . . . 78 Beep Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Blood, Getting a Drop of . . . . . . . . . . . . . . . . . . . . . 27 Blood, How to T est Y our . .
Meter , Doing a Daily Check of . . . . . . . . . . . . . . . . . 73 Meter On/Off Button . . . . . . . . . . . . . . . . . . . . . . . . . 7 Meter Options, Setting . . . . . . . . . . . . . . . . . . . . . . 47 – Beep Prompts . . . . . . . . . . . . .
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El folleto para el propietario del OneT ouch ® Basic ® se encuentra disponible en español. Para r ecibir su copia gratuita, favor de llamar al número gr atis 1 800 381-7226 . The OneT ouch ® Basic ® instructional materials are available in Spanish.
An important point after buying a device Lifescan Basic Blood Glucose Monitoring System (or even before the purchase) is to read its user manual. We should do this for several simple reasons:
If you have not bought Lifescan Basic Blood Glucose Monitoring System yet, this is a good time to familiarize yourself with the basic data on the product. First of all view first pages of the manual, you can find above. You should find there the most important technical data Lifescan Basic Blood Glucose Monitoring System - thus you can check whether the hardware meets your expectations. When delving into next pages of the user manual, Lifescan Basic Blood Glucose Monitoring System you will learn all the available features of the product, as well as information on its operation. The information that you get Lifescan Basic Blood Glucose Monitoring System will certainly help you make a decision on the purchase.
If you already are a holder of Lifescan Basic Blood Glucose Monitoring System, but have not read the manual yet, you should do it for the reasons described above. You will learn then if you properly used the available features, and whether you have not made any mistakes, which can shorten the lifetime Lifescan Basic Blood Glucose Monitoring System.
However, one of the most important roles played by the user manual is to help in solving problems with Lifescan Basic Blood Glucose Monitoring System. Almost always you will find there Troubleshooting, which are the most frequently occurring failures and malfunctions of the device Lifescan Basic Blood Glucose Monitoring System along with tips on how to solve them. Even if you fail to solve the problem, the manual will show you a further procedure – contact to the customer service center or the nearest service center
