Lifescan OneTouch Profile blood glucose monitor User's Manual
Contents
1. Owner s Booklet Complete Diabetes Tracking System For diabetes and life CAUTION Before using any product to test your blood glucose blood sugar read all instructions and practise the test Do all quality control checks as directed and consult with a diabetes health care professional The One Touch Profile System is intended for use outside the body in vitro diagnostic use It should be used only for testing purposes and only with whole blood not plasma or serum It should not be used for the diagnosis of diabetes and has not been validated for testing the blood of newborns The One Touch Profile System contains many small parts which may be dangerous if swallowed It is therefore best to keep the system away from small children 1 Introduction 4 Precautions and limitations 5 One Touch Profile Blood Glucose Meter 6 One Touch Test Strips 8 SETTING THE SYSTEM Coding the meter 10 Check strip test 12 Control solution test 16 TESTING YOUR BLOOD Getting a drop of blood 22 Step by step test procedure 29 Event labelling 35 USING THE METER MEMORY Entering the memory 37 Recalling results 38 CHANGING METER SETTINGS Entering the set up options mode 40 Beep prompts 42 2 TABLE OF CONTENTS Time and date 43 Event averaging 44 Insulin prompt 45 Insulin programming 46 Display language 48 Time format 49 Date format 49 Decimal separator 50 Unit of measure2. 0 0mmol L DEC PT M MOVE C CHANGE 0 0mmol L COMMA M MOVE C CHANGE 50 To change the decimal separator enter the set up mode Use the M button to choose the decimal separator option Press the C button to choose the deci mal separator EXITING THE SET UP MODE After you have completed viewing or changing your option settings simply turn the meter off The meter will auto matically exit the set up mode and turn itself off after two minutes 51 UNIT OF MEASURE The meter is pre set to display test results in milligrams per decilitre mg dL You have the option to select millimoles per litre mmol L To change the unit of measure enter the set up mode Use the M button to choose the unit of measure option Press the C button to change the unit of measure M MOVE C CHANGE mmol L M MOVE C CHANGE mg dL The display messages that appear on your One Touch Profile Meter will guide you through testing procedures alert you to any problems as they occur and give you informa tion about test results stored in the meter s memory This section provides you with a com plete listing of the display messages what they mean and what to do if there is a problem TEST PROCEDURE MESSAGES CODE 10 The meter is first turned on The code number 1 16 on the for example meter must match the code number on the test strip vial 7 26 AM 6 01 00 INSERT The meter is ready to perform a blood check strip or cont
3. signs on the batteries are cor rectly aligned To replace the battery compartment door insert the tab on the top of the door into 68 the slot in the top of the battery compart ment Press the opening tab upward toward the top of the meter Lower the battery compartment door until it snaps shut Check to see that your meter is working If not reinstall the batteries PERFORMANCE CHARACTERISTICS Power Supply 2 x 1 5V alkaline batteries AAA Battery Life Approximately one year when testing up to four times a day Result Range 0 600 mg dL 0 33 3 mmol L Values of 600 mg dL 33 3 mmol L and above displayed as HI Display Type Liquid crystal Blood Source Whole blood capillary or venous Do not use samples that contain fluoride grey top tubes Haematocrit Range 25 60 Dimensions Length 10 9 cm 4 3 inches Width 6 6 cm 2 6 inches Height 3 0 cm 1 2 inches Weight 127 5 grams 4 5 ounces with batteries Operating Temperatures 15 35 C 59 95 F Operating Humidity Range 0 90 relative humidity non condensing Altitude One Touch Brand Glucose Monitoring Systems based on One Touch technology have been shown to give equivalent perfor mance when tested at altitudes up to 2200 meters 7200 feet Memory Up to 250 records with time and date Data Port RS 232 serial communications with special LifeScan cable for interface with LifeScan InTouch Diabetes Management S
4. display language option Press the C button until the language you want appears on the display 48 DISPLAY LANGUAGE The One Touch Profile Meter can display messages in 19 languages English ENGL Spanish ESPAN French FRANC Italian ITALIA Hungarian MAGYAR Dutch NEDER Norwegian NORSK Polish POLSKI Portuguese PORT Russian PYCCK Finnish SUOMI Swedish SVENS Turkish TURKCE Symbolic 0XOOXO British BRIT Czech CESKY Danish DANSK German DEUTS and Greek E IKA DATE FORMAT The meter is pre set to display the date as month day year For example June 01 2000 reads as 6 01 00 You can set the meter to display day month year To change the date format enter the options mode Use the M button to choose the date format option Press the C button to change the date format TIME FORMAT The meter is pre set to display the time in the 12 hour AM PM format However an alternative 24 hour time format is available To change the time format enter the set up mode Use the M button to choose the time format option Press the C button to change the time for mat M D Y M MOVE C CHANGE D M Y M MOVE C CHANGE AM PM M MOVE C CHANGE 49 DECIMAL SEPARATOR The meter is pre set to display mil limoles per litre mmol L and basal insulin rate values using a decimal point This option allows you to select a comma instead of a decimal point as a decimal separator
5. with batteries already installed When the batteries need to be replaced use two AAA 1 5 volt alkaline batteries The batteries should last about one year when testing up to 4 times a day When the battery symbol appears on the meter display the batteries are getting low The meter will still provide accurate test results with low batteries but they should be replaced as soon as possible 66 C M When BATTRY REPLACE NOW appears flashing on the display the meter will no longer give results and you must replace the batter ies before you can perform another test Dead batteries or battery removal will not affect the information stored in the meter memory The time and date will be saved in the meter for approximately an hour without the batteries Step 1 Turn the meter over and locate the battery compartment door Make sure the meter is turned off before you remove the batteries Step 2 Remove the battery compart ment door Turn the meter over so that the front is resting in the palm of your hand With your thumb press upward on the opening tab of the battery compartment door and lift upward until it releases from the clasp 67 Step 3 Remove the old batteries Remove the old batteries by gently slapping the meter against the palm of your hand Never tap the meter against a hard surface Step 4 Insert the new AAA batteries into the battery compartment Make sure that the plus and minus
6. 3 Repeat the test with the new test strip Clean the meter and check strip if necessary Repeat the test MESSAGE NOT OK 58 MG DL or 3 2 MMOL L for example NOT OK 7 40 AM 6 01 00 61 PROBLEM The last check strip test was outside the acceptable range and an acceptable repeat test was not performed The last test failed after the countdown started The meter has lost some important information including the code number Some parts of the display are not working WHAT TO DO Repeat the checkstrip test Repeat the test Use the C button to reset the meter code to match the code on the test strip vial You should also check all of your meter option settings to be sure they are cor rect If this continues to happen there may be a problem with your meter Call your authorized LifeScan representative Call your authorized LifeScan represen tative MESSAGE REDO RETEST RESET CODE To keep your One Touch Profile Blood Glucose Meter in good operating condition follow these simple rules Keep the test strip holder and test area clean Keep your meter dry If you acciden tally get water or other liquids inside the meter check the meter by doing check strip tests see page 12 and control solution tests see page 16 to be sure it is operating properly Avoid exposing your meter to extremes in temperature or humidity For exam ple do not leave it in your car I
7. 51 Exiting the set up mode 51 SOLVING PROBLEMS Test procedure messages 52 Error messages 56 TAKING CARE OF YOUR METER Cleaning the meter 63 Replacing the batteries 66 SPECIFICATIONS Performance characteristics 69 Warranty 70 Insulin Types 71 3 INTRODUCTION The One Touch Profile Glucose Monitoring System is for people with diabetes who need to check the level of glucose sugar in their blood To per form a blood glucose test a One Touch Test Strip is inserted into the meter and a small sample of blood is applied to the test strip The meter then measures the blood glucose level and displays the result in just 45 seconds Easy to understand symbols guide you through the test procedure and help you if any problems arise 4 The One Touch Profile Glucose Monitoring System consists of three main products The One Touch Profile Blood Glucose Meter One Touch Test Strips and One Touch Normal Control Solution For reliable results and to maintain the manufacturer s total service support and warranty use only One Touch Profile System products made by LifeScan PRECAUTIONS AND LIMITATIONS If you experience symptoms that are not consistent with your blood glucose results and you have carefully followed the procedure described in your owner s booklet contact your healthcare professional immediately DO NOT make significant changes to your medication program or ign
8. Test Strips beyond the expiration date on the vial DO NOT use One Touch Test Strips with plasma or serum samples as the results will not be accurate The strips are intended for use with fresh whole blood or One Touch Normal Control Solution When you open a new vial of test strips record the date vial first opened Discard unused test strips four months after first opening the vial DO NOT use One Touch Test Strips that are bent torn cut or changed in any way Use each test strip immediately after removing it from the vial Replace the test strip vial cap immediately after removing a test strip from the vial Close cap tightly Do not transfer the test strips from the original vial to any other container Do not carry unwrapped test strips in your meter case DO NOT use bleach or products containing bleach near the test strips For reliable results use only One Touch Test Strips made by LifeScan 9 INSERT STRIP CODE 9 CODE 9 7 26AM 1 06 00 CODING THE METER Code numbers are used to calibrate the meter with the test strips for reliable results Make sure you set the code Before using the meter for the first time Every time you change to another vial of test strips Check that the code number on the display matches the code number on the test strip vial Step 1 Turn on the meter The meter code will appear on the display for a moment along with the current time and da
9. Use the M button to recall the information stored in your meter s memory and to review your meter s set up options C Button Use the C button to set the code on the One Touch Profile Meter and to change the meter s set up options Test strip holder The test strip holder holds a One Touch Test Strip in place when you perform a blood glucose or control solution test Test area The test area is located under the test strip holder Battery compartment Holds two AAA batteries The batteries are already installed in your meter Data port Allows you to transfer the infor mation stored in the meter s memory to a computer to view analyse and print Please call your authorized LifeScan representative for more information about our Diabetes Management System software 7 ONE TOUCH TEST STRIPS When blood is applied to the white test spot on the test strip compounds on the test strip react with the blood to form a blue color The meter reads the color to determine the blood glucose level 8 TEST SPOT OR THIS NOTE Your test strip may look like THIS Consult your test strip package insert for specific test strip information TEST SPOT IMPORTANT TEST STRIP INFORMATION One Touch Test Strips are sensitive to heat and light Keep them sealed in the origi nal vial and store in a cool dry place below 30 C 86 F Do not refrigerate or place in direct heat or sunlight DO NOT use One Touch
10. Your blood glucose test result is 60 mg dL 3 3 mmol L The message DO YOU NEED A SNACK appears when your blood glucose test is 60 mg dL 3 3 mmol L or below possi bly indicating hypoglycaemia you may need food immediately Your blood glucose test result is 240 mg dL 13 3 mmol L The message CHECK KETONES appears when your blood glucose test is above 240 mg dL 13 3 mmol L and below 600 mg dL 33 3 mmol L You may need to check your urine for ketones 55 MESSAGE APPEARS WHEN HI MG DL or HI MMOL L DANGER 8 01 AM 6 01 00 alternating with HI MG DL or HI MMOL L CALL DR TEST KETONES Your blood glucose test result is 600 mg dL 33 3 mmol L This level is severe hyperglycemia Contact your doctor immediately Appears briefly when the meter is turned on You can see that all of the display segments are working properly When any of the following messages appear there is a problem with your One Touch Profile Meter or the way in which you are performing a test In most cases problems are easy to fix If you still have trouble call your authorized LifeScan representative ERROR MESSAGES PROBLEM When this symbol appears and stays on the screen it means the batteries are getting low This symbol will remain on the dis play while the meter is on until the batteries are replaced When this symbol is flashing the batteries are too low WHAT TO DO Test results will still be accurate but replace the
11. batteries as soon as possible Replace the batteries immediately The meter will not operate MESSAGE 56 57 PROBLEM 1 There is dirt blood or lint on the test area 2 Your hand or an object cov ered the test area during testing 3 The meter was used in very bright light The test strip was inserted before the word INSERT appeared on the display If the word CONTRL appears after a blood test your blood sample was too small smeared or another drop was added after the test began WHAT TO DO 1 Clean the test area according to instructions 2 Repeat the test Keep test area clear 3 Move the meter away from the light source Repeat the test with a new test strip Remove the strip Wait for the word INSERT before inserting test strip Repeat the test with a new test strip and apply a larger drop of blood MESSAGE REMOVE STRIP CLEAN TEST AREA 100 MG DL or 5 6 MMOL L for example CONTRL 8 01AM 6 01 00 58 PROBLEM The sample was applied before the words APPLY SAMPLE appeared 1 The test strip moved during the test 2 The test strip was not insert ed correctly 3 The test strip was removed before the test was completed 4 There was not enough blood on the test strip 5 The meter was used in very bright light WHAT TO DO Repeat the test with a new test strip 1 Repeat the test with a new test strip 2 Repeat the test with a new test strip 3 Rep
12. or freeze WARNINGS Control solution is not to be used as a cleaning solution Do not swallow or inject control solution or place drops into the eyes 17 The control solution test follows the normal test procedure using control solution instead of blood Step 1 Turn on the meter The code number time and date will appear The code number should match the code number on the test strip vial Step 2 Insert a test strip When INSERT CODE 10 for exam ple STRIP appears slide a test strip into the test strip holder notched end first with the test spot facing up Make sure you push the test strip in all the way until it stops 18 C M C M CODE 10 7 50AM 1 06 00 INSERT Step 3 Apply control solution After the test strip is in the test strip holder WAIT PLEASE appears for a moment then APPLY SAMPLE appears Shake the control solution vial well before removing the cap and adding a drop of control solution to the middle of the test spot covering it completely 19 C M Normal Glucose Control Solution R APPLY 20 Step 4 The result appears within 45 seconds Compare the control solution test result with the control solution range printed on the One Touch Test Strip vial When the control solution test result lies within the control range you are ready to test your blood C M 100 mg dL CONTRL 7 52AM 1 06 00 Record control solution tests in the log book provided b
13. seconds before pricking your finger 26 Gently massage your finger to obtain the required blood volume Proceed with your blood glucose test see Step by Step Test Procedure page 29 Hold the Penlet Plus Sampler firmly against the side of your finger with the cap resting on your finger Greater pressure of the device against the finger will cause a deeper puncture Press the release button 27 Optional To replace the protective disk on the lancet place the disk on a hard surface and push the exposed tip into the protective disk Caution Always use caution when removing the lancet Step 6 Remove the Lancet To remove the Penlet Plus Cap twist the cap counterclockwise 28 Return the ejection cocking control to the middle position Replace the cap Point the lancet down and away from you Push forward on the ejection cocking control and eject the lancet directly into an appropriate container for sharp objects CLEANING THE PENLET PLUS SAMPLER Clean the Penlet Plus Sampler with soap and water as needed To disinfect the Penlet Plus Sampler and cap prepare a disinfectant solu tion of one part household bleach to 10 parts water Dampen a cloth in this solution then wipe the Penlet Plus Sampler thoroughly Soak only the cap for at least 30 minutes in the disin fectant solution Rinse the Penlet Plus Sampler and cap with water and dry thoroughly STEP BY STEP TEST PROCE
14. DURE Step 1 Turn on the meter Press the power button A code number and the date and time will appear The code number must match the code number on the test strip vial If it does not change the meter code number fol lowing the instructions on page 11 29 M C CODE 10 8 00AM 1 06 00 CODE 10 8 00AM 1 06 00 WAIT PLEASE APPLY SAMPLE Step 2 Insert a test strip Next INSERT CODE 10 for exam ple STRIP appears Slide a test strip into the strip holder notched end first with the test spot facing up Make sure you push the test strip in all the way until it stops After WAIT PLEASE the meter shows APPLY SAMPLE You then have 5 minutes to apply blood to the test spot otherwise the meter auto matically turns off 30 Example M C INSERT INSERT CODE 10 STRIP Many times the meter can detect if there is not enough blood and will show but you should also look at the test strip to make sure Step 3 Apply blood to the test spot Apply blood to the test spot so as to cover it completely with a round drop It is very important that enough blood is applied Do not Smear blood onto the test spot Apply a second drop after the test begins Move the test strip as you apply blood Remove the test strip from the meter to apply blood 31 C M APPLY NOT BLOOD ENOUGH RETEST 32 Checking the amount of blood on the test strip Remove the test strip fr
15. G METER SETTINGS The meter will then automatically pre sent the first option screen The options map below will help guide you through the option screens Use the M button to scroll through the options or move within an option If you want to change an option set ting use the C button Once you have finished setting an op tion turn the meter off or press the M button to move to the next option Note You can exit the options mode at any time by turning off the meter If after two minutes you have not made a selection the meter will turn itself off automatically All option settings are saved as they are made Entering insulin records in the set up mode is not recommended 41 ON BEEP M MOVE C CHANGE 10 00AM M MOVE C CHANGE 08 15 00 M MOVE C CHANGE OFF INSULN M MOVE C CHANGE OFF AVG M MOVE C CHANGE 00 UNITS SHORT M MOVE C CHANGE ENGL M MOVE C CHANGE AM PM M MOVE C CHANGE MDY M MOVE C CHANGE mg dL M MOVE C CHANGE 0 0 DEC PT M MOVE C CHANGE BEEP PROMPTS The One Touch Profile Meter uses beeping tones to signal various steps in the meter procedures The beep option is seen immediately after entering the set up mode The current set ting will automatically appear on the display With the ON setting the meter will continue to provide beep prompts dur ing the test procedure ON BEEP M MOVE C CHANGE 42 Press the C button to turn off the beep prompt
16. NITS INTERM M MOVE C CHANGE 45 UNITS INTERM M MOVE C CHANGE INSULIN PROGRAMMING If you want to enter several insulin records at a time or if you forgot to enter your insulin information after a test use the insulin programming option in the meter set up In the set up mode use the M button to choose the insulin programming option Press the C button the insulin type will flash Continue pressing the C button until your insulin type is displayed Press the M button to move to the units area Use the C button to enter your insulin units In the same way pressing the M button will allow you to move to the hour minutes year month and day to complete your insulin record Use the C button to change the information in each area 46 After you have moved through each area the complete record will be dis played for two seconds followed by another insulin programming screen You may then press the C button to enter another insulin record 47 CARBOHYDRATE COUNTING You can use the insulin programming feature to record the number of grams of carbohydrate in your diet Follow the steps for insulin programming but select CARBOH instead of an insulin type Enter the number of carbohy drates from 1 to 150 000 CARBOH M MOVE C CHANGE 35 CARBOH M MOVE C CHANGE The One Touch Profile Meter is pre set to prompt you in English To change the display language enter the set up mode Use the M button to choose the
17. display remove the check strip from the test strip holder Note This is the only time you should remove a strip during a test 13 M C 1 M C 1 INSERT SAMPLE The display will show OK if your result falls within the correct check strip range printed on the back of your meter If the reading is not within the recommended range the meter display will show NOTOK REDO Repeat the check strip test until your result falls within the correct range Step 4 Turn the check strip over and insert it back into the meter When INSERT SIDE 2 STRIP appears turn the check strip over and slide it back into the test strip holder It must go in notched end first the white side facing up The meter counts down from 4 to 0 and then gives you a check strip result M C 2 14 58 mg dL REDO Example 80 mg dL OK 7 40AM 1 06 00 4 4mmol L OK 7 40AM 1 06 00 58 mg dL NOTOK 7 40AM 1 06 00 3 2mmol L REDO 3 2mmol L NOTOK 7 40AM 1 06 00 Example IMPORTANT CHECK STRIP INFORMATION If your check strip result is repeatedly out of range your meter may not be working properly Do not use the meter to test your blood until you get a check strip result that is within the correct range Make sure both sides of the check strip are clean If necessary wipe the check strip with a soft cloth or tissue dampened with water Dry it completely Do not get blood alcohol control solution or any ot
18. e average 106 mg dL OK 8 01AM 1 06 00 100 mg dL CONTRL 7 52AM 1 06 00 80 mg dL 7 40AM 1 06 00 5 9mmol L OK 8 01AM 1 06 00 5 6mmol L CONTRL 7 52AM 1 06 00 4 4mmol L 7 40AM 1 06 00 120 mg dL AVG 14 DAY 6 7mmol L AVG 14 DAY 38 TESTS 14 DAY NODATA You can change or add event labels or insulin information stored in memory while they are displayed on the meter To delete an insulin record simply select 00 for the units See pages 35 on event labelling and pages 45 47 on the insulin prompt and insulin programming 45 UNITS INTERM 8 05AM 1 06 00 39 Any event labels added to blood glucose tests will alternate with the time and date when shown on the meter 130 mg dL 11 00AM 1 06 00 130 mg dL PRE NOON MEAL 7 2mmol L 11 00AM 1 06 00 7 2mmol L PRE NOON MEAL SET UP OPTIONS MODE You can change or in some cases turn off 11 features of your One Touch Profile Meter to suit your individual needs Beep prompts Time Date Event averaging Insulin prompt Insulin programming Display language Time format Date format Unit of measure Decimal separator ENTERING THE SET UP OPTIONS MODE 1 Make sure the meter is off 2 Press and hold the power button for about three seconds until the display begins to flash 3 Release the power button 4 The following screens will appear 40 CHANGIN
19. eat the test with a new test strip 4 Repeat the test with a new test strip 5 Move the meter away from the light source Repeat the test with a new test strip MESSAGE ERROR 1 RETEST ERROR 2 RETEST 59 PROBLEM 6 The check strip procedure was incorrect 7 The meter may not be operating correctly 1 The blood or control solu tion sample was too small or smeared 2 Your hand or an object cov ered the test area while the meter was turned on 3 The test strip was not insert ed far enough into the test strip holder WHAT TO DO 6 Repeat the check strip test 7 Call your authorized LifeScan representative 1 Repeat the test with a new test strip and a large shiny drop of blood or control solution 2 Repeat the test with a new test strip Keep the meter s test area clear 3 Repeat the test pushing the test strip all the way into the test strip holder MESSAGE NOT ENOUGH BLOOD RETEST 60 PROBLEM 1 If appearing when you turn your meter on your meter may have an electronic problem 2 If appearing at the end of a test your meter may have been moved while applying blood or during the test process 3 If appearing during the test the strip has been removed at the WAIT PLEASE screen The check strip test result is outside the acceptable range WHAT TO DO 1 Call your authorized LifeScan representative 2 Repeat the test try not to move the meter
20. est strip holder with soap and water Clean the underside of the test strip hold er Using a cotton swab clean the small hole to remove any dirt blood or lint Rinse well Dry completely with a soft cloth or tissue Step 3 Clean the test area Check the clear protective coating over the test area to make sure it is not scratched or dam aged 64 CAUTION Do not use the following agents for cleaning as they will damage the meter Alcohol Cleansers with ammonia or phenol Glass cleaners Abrasive cleaners C M Rub the test area with a cotton swab or soft cloth dampened with water to remove all blood dirt or lint from the test area If necessary a mild liquid dish washing detergent mixed with water may also be used Do not apply full strength detergent to the test area Be careful not to scratch the test area Dry the test area with a soft dry tissue or cloth Remove any lint Step 4 Replace the Test Strip Holder Hook the bottom of the test strip holder onto the square notch on the meter Press down on the raised dots of the test strip holder until it snaps firmly into place 65 C M C M C M Press forward on the base of the test strip holder to be sure it is properly in place You are now ready to do a check strip test If the check strip will not slide into the test strip holder repeat Step 4 REPLACING THE BATTERIES The One Touch Profile Meter comes
21. f you drop the meter make sure the test strip holder is still securely in place Check the meter by doing check strip and control solution tests to be sure your meter is working properly Do not take the meter apart Sensitive parts could be damaged causing false results Taking the meter apart will void the warranty Do not clean the meter with alcohol as this will damage the meter 62 TAKING CARE OF YOUR METER CAUTION Do not get water inside the meter Do not immerse the meter or hold if under running water CLEANING THE METER DO A DAILY CHECK Look through the small hole in the test strip holder to make sure there is no lint dirt or blood blocking it If there is anything blocking the hole or if the test area has dirt lint or blood on it remove the test strip holder and clean the test area by following the instructions given below Then do a check strip test Clean the meter and test strip holder At least once each week Whenever the test area looks dirty Whenever CLEAN TEST AREA appears on the display Clean the meter using these easy steps Step 1 Remove the test strip holder from the meter Hold the meter and place your thumbs on the two raised dots on the test strip holder Press down on the raised dots and slide the test strip holder toward you Remove the test strip holder to expose the test area 63 C M Step 2 Clean the test strip holder Wash the t
22. her fluid 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 your authorized LifeScan representative for a free replacement 15 CONTROL SOLUTION TEST One Touch Normal Control Solution is used instead of blood to tell you that the meter and test strips are working togeth er properly The control solution con tains a known amount of glucose that reacts with a One Touch Test Strip Do a control solution test Before using your meter for the first time Each time you open a new vial of test strips At least once a week Whenever you suspect that the meter or test strips are not working properly When your results do not reflect how you feel If you drop the meter 16 Sha For Nor Dis Un Lot LIF AW Normal Glucose Control Solution R IMPORTANT CONTROL SOLUTION TEST INFORMATION Use only One Touch Normal Control Solution Check the expiration date of the control solution Do not use if expired Record the discard date on the vial Discard the vial 90 days after first opening The control solution range printed on the test strip vial is for One Touch Normal Control Solution only It is NOT a recommended range for your blood glucose level Store the glucose control solution at room temperatures below 30 C 86 F Do not refrigerate
23. ng insulin taken over baseline amount CARBOH Carbohydrate intake 20 80 Mixture 20 Short and 80 Intermediate 40 60 Mixture 40 Short and 60 Intermediate UNITS WILL ADVANCE ON THE DISPLAY AS FOLLOWS BOLUS 0 0 20 0 steps of 0 1 CARBOH 0 150 steps of 1 All others 0 99 steps of 1 71 INSULIN TYPES 1995 The enclosed LifeScan Blood Glucose Meter as an electro medical device has been thoroughly tested and found to comply with the essential requirements of the ElectroMagnetic Compatibility Directive EMC 89 336 EEC 1995 For further information on LifeScan products please call your authorized LifeScan representative LifeScan Inc 2000 Milpitas California 95035 U S A U S and foreign patents other patents pending IFD OB OTP Rev 02 2000
24. ns not more than 3g s ilica gel Prot ecte d un der t he f ollo wing U S Pate nts 4 935 346 5 0 49 4 87 and othe r pa ten ts p end ing 25 Test Strips M C CODE 9 CODE 10 It is very important that you do the fol lowing two simple checks routinely to make sure you get accurate results CHECK STRIP TEST A purple and white check strip is included in your meter case Before doing a check strip test make sure the test strip holder test area and check strip are clean dry and lint free Do the check strip test at room temperature between 18 and 26 C 64 F 79 F Do a check strip test At least once a day After cleaning the meter Whenever your blood glucose test results are not consistent with how you feel or when you think your results are not accurate Whenever the REDO message appears before the INSERT CODE 10 for example STRIP prompt 12 1 2 Front Back REDO Step 1 Turn on the meter The code number will appear on the display Next INSERT CODE 10 for example STRIP will appear Step 2 Insert the check strip Slide the notched end of the check strip into the test strip holder with the purple side facing up After the check strip has been insert ed WAIT PLEASE appears for a mo ment Step 3 Remove the check strip When the message APPLY SAMPLE appears on the
25. om the meter and look at the test spot It should still have a wet shiny drop that complete ly covers the circle If the blood sample has a dull dry appearance you may not have applied enough blood or you may have smeared it Look at the back of the strip You should see a full dark circle If there are any white patches or streaks as shown in illus trations you may have smeared the blood or the drop was too small In either case you have an inaccurate ly low result Repeat test with a new test strip Front Side Back The meter displays results above 600 mg dL or 33 3 mmol L as HI DANGER A result that reads HI DANGER means very high blood glucose severe hyperglycemia 33 Accurate results in 45 seconds The meter then counts down from 45 to 0 seconds beeps and displays your result Remove the test strip only after the result is displayed C M 106mg dL 8 01AM 1 06 00 5 9mmol L HI mg dL 8 01 AM 1 06 00 HI mg dL CALL DR TEST KETONES HImmol L DANGER DANGER 8 01 AM 1 06 00 HImmol L CALL DR CHECK KETONES 8 01AM 1 06 00 Test results below 60 mg dL or 3 3 mmol L mean your blood glucose is low hypoglycemia IMPORTANT If you get a HI DAN GER result or a result below 60 mg dL or 3 3 mmol L and your test result does not reflect how you feel follow the guidelines on pages 16 20 to ensure testing accuracy Then repeat the test using a new test strip Record y
26. ontamination and to prevent the cap from rolling away set it down on a flat surface with the small hole pointing up 23 Step 2 Adjust Puncture Depth Twist the depth adjustment knob located at the end of the Penlet Plus Sampler to desired puncture setting Smaller bumps are for shallower punc tures while larger bumps are used for deeper punctures Gently twist off the lancet s protective disk Make two full turns to ensure that the lancet separates from the protective disk Optional For safe disposal save protective disk to cover lancet after use See Step 6 option Replace the Penlet Plus Cap Turn the cap clockwise until it is snug but not overly tight 24 Step 3 Cock the Penlet Plus Sampler Slide the ejection cocking control back until you hear a click If it does not click the Penlet Plus Sampler may have been cocked when the lancet was inserted Step 4 Wash Your Hands Wash your hands with soap and warm water Warm water stimulates blood flow to the fingers Rinse and dry hands thoroughly 25 Choose a spot on the side of a different finger each time you test Repeated punctures in the same spot may cause soreness and calluses Step 5 Get a Drop of Blood Helpful tips To increase blood flow to your finger tips massage the hand from the wrist to the fingertip two or three times without touching the puncture site Hang your arm down at your side for 10 to 15
27. ore physical symptoms without consulting your healthcare professional If the message HI DANGER appears on the meter display this indicates severe high blood sugar hyperglycemia contact your doctor immediately Note that extremes in whole blood hematocrits above 60 or below 25 can cause false low results Reducing substances such as Vitamin C ascorbic acid have little effect on blood glucose results when found in normal blood concentrations However abnormally high concentrations of reducing substances in blood will cause false low test results DO NOT use blood samples with preservatives that contain fluoride in gray top test tubes You will get false low results When testing removal of the test strip prior to display of the blood glucose result may give you a false result 5 ONE TOUCH PROFILE BLOOD GLUCOSE METER Study this diagram to become familiar with all of the parts of your One Touch Profile Meter 6 Battery Compartment on back Data Port C M C Button Test Strip Holder Display Test Area with protective coating M Button On Off Button On off button This button turns the meter on and off Display This is where you read the simple messages that guide you through test ing setting options and using the memory Your test results will be dis played here M Button The One Touch Profile Meter automatically stores your test results
28. our test result in your logbook You may also want to add event labels or insulin information Instructions on how to do this are provided on pages 35 47 Press the power button to turn off the meter 34 Contact your healthcare professional immediately if you continue to get HI DANGER test results or results below 60 mg dL or 3 3 mmol L 60 mg dL DO YOU NEED A SNACK 3 3mmol L DO YOU NEED A SNACK 60 mg dL 8 01AM 1 06 00 3 3mmol L 8 01AM 1 06 00 EVENT LABELLING Immediately after testing your blood you may want to mark your glucose readings with event labels The One Touch Profile meter has 15 sepa rate event labels 35 FASTING PRE BREAKFAST AFTER BREAKFAST PRE NOON MEAL AFTER NOON MEAL PRE DINNER AFTER DINNER DIFFERENT FOOD BEDTIME DURING NIGHT PRE EXERCISE AFTER EXERCISE ILLNESS HYPOGLYCEMIA OTHER You can link an event label to your blood glucose result immediately after testing or later when reviewing the tests stored in your meter s memory It will appear on the meter display with your test result alternating with the time and date 36 To select an event label press the C but ton while the blood glucose test result is still showing on the meter dis play Each time you press the C button a new event label will appear on the display Hold the C button down to move more rapidly through the lis
29. rol CODE 10 for example solution test STRIP WAIT The meter is performing internal checks PLEASE APPLY The meter is ready to receive a blood or control solution sample SAMPLE If performing a check strip test this is your signal to remove the check strip purple side up from the meter 52 SOLVING PROBLEMS MESSAGE APPEARS WHEN 45 0 106 MG DL or 5 9 MMOL L A blood test has been completed This indicates a blood glucose for example resultwhen the meter is set for mg dL or for mmol L 8 01 AM 6 01 00 100 MG DL or 5 6 MMOL L for example CONTRL 7 52 AM 6 01 00 INSERT SIDE 2 80 MG DL or 4 4 MMOL L for example OK 7 40 AM 6 01 00 53 A control solution test has been completed If you have just performed a blood glucose test this means that the blood sample was too small and the meter read it as control solu tion Repeat the test with a new test strip You are performing a check strip test Turn the check strip over and insert Side 2 The meter is counting down from 45 seconds to 0 The check strip test result falls into the acceptable range which is printed on the back of your meter MESSAGE APPEARS WHEN 60 MG DL or 3 3 MMOL L for example 8 01 AM 6 01 00 alternating with 60 MG DL or 3 3 MMOL L for example DO YOU NEED A SNACK 240 MG DL or 13 3 MMOL L for example 8 01 AM 6 01 00 alternating with 240 MG DL or 13 3 MMOL L CHECK KETONES 54 MESSAGE APPEARS WHEN
30. s The following display will appear You may now turn off the meter or press the M button to move to the next option OFF BEEP M MOVE C CHANGE TIME AND DATE In the set up mode use the M button to choose the Time option The current time will show Press the C button to change the time the hour and AM or PM will flash Press the C button again to advance the hour to the correct set ting Now press the M button and the minutes will flash Use the C button to change the minutes Press the M button to see the new time setting To set the date press the M button in set up mode The current date will show Press the C button the year will flash Press the C button again to change the year to the correct setting Now press the M button and the month will flash Use the C button to change the month Press the M button and the day will flash Press the C but ton to change the day Press the M button again to display the new date setting 6 01 00 M MOVE C CHANGE 43 9 00AM M MOVE C CHANGE EVENT AVERAGING In the set up mode use the M button to choose the event averaging option Press the C button to turn on the event averag ing option ON AVG M MOVE C CHANGE OFF AVG M MOVE C CHANGE 44 Averages for each event are displayed by pressing the M button to move from one event to the next Averages for up to 15 separate events and the 30 day test average of your blood glucose test results are shown A
31. t When you stop the event label is set and stored in memory M C M C 130mg dL AFTER BREAKFAST 7 2mmol L AFTER BREAKFAST 130mg dL PRE NOON MEAL 7 2mmol L PRENOON MEAL 130 mg dL PRE NOON MEAL 7 2mmol L PRE NOON MEAL 7 2mmol L 11 00AM 1 06 00 130 mg dL 11 00AM 1 06 00 ENTERING THE MEMORY Turn on the meter Press the M button to enter the meter memory The word MEMORY will appear briefly MEMORY M C The One Touch Profile Meter stores up to 250 test results with date and time Event labels and insulin records are also stored When the memory is full the oldest record is dropped as a new one is added However if you have used the meter at least once in the past 14 days the aver age of your blood glucose test results over the past 14 days will appear Check strip and control solution tests are not included 37 USING THE METER MEMORY M C INSERT MEMORY The very first time you turn on your meter and press the M button the fol lowing message will appear showing that there are no results stored in the memory RECALLING RESULTS Turn on the meter Press the M button to enter the memory Press the M button again and again to see each of your blood glucose check strip control solution and insulin records The records appear in order the most recent being shown first 38 Now press and hold the C button to see how many tests are included in th
32. t least one blood glucose result must have been linked to an event in the previous 14 days for it to appear Note When the time and date are changed the calculated 14 day 30 day and event averages may change 120 mg dL AVG FASTING 6 7mmol L AVG FASTING Step 1 Change the insulin type When a type of insulin SHORT for example is flashing on the meter press the C button until your first type of insulin appears on the display 00 UNITS SHORT M MOVE C CHANGE 00 UNITS INTERM M MOVE C CHANGE INSULIN PROMPT You can add information about your insulin type and dosage after each blood glucose test result In the set up mode use the M button to choose the insulin prompt option The above example will appear To turn on the in sulin prompt press the C button From now on leave the meter on after completing a test Then whenever you remove the test strip or check strip insulin prompts will be displayed on the meter ON INSULN M MOVE C CHANGE OFF INSULN M MOVE C CHANGE 45 Press the M button to al low you to set the units INSULN FIRST TYPE 00 UNITS SHORT M MOVE C CHANGE Step 2 Change the insulin units When the units area is flashing 00 press the C button until your insulin dose is displayed Press the M button again and follow the same steps to enter your second type of insulin and the dose 00 UNITS SHORT M MOVE C CHANGE INSULN SECOND TYPE 00 U
33. te and then the message INSERT CODE 9 for example STRIP will appear 10 SETTING THE SYSTEM Step 2 Match the Code Numbers If the code number on the display matches the code number on your test strip vial you may begin testing If the two code numbers do not match follow Step 3 to code the meter Step 3 Code the Meter After the word INSERT is dis played on the meter press and release the C button the code number will appear Continue pressing the C button until the number on the display matches the code number on the test strip vial The code number is now set for the vial of test strips you are using and the meter will remember this code number until you change it You are now ready to do a test 11 M C 10 Code Do no t s to re Te st Str ips ou tsi de th e v ial Tes t fo r th e q uan tita tiv e Blo od Blu cos e M ete rs For use wit h O NE TO UC H in wh ole blo od mea sur em ent of g luc ose Ins tru ctio ns Rea d usi ng thi s p rod uct pac kag e in ser t be for e For in v itro diag nost ic u se o nly Stor e in a co ol d ry p lace at te mpe ratu res und er 8 6 F 30 C D o no t ref rige rate Vial Cap cont ai
34. y placing a C next to the result If test results fall outside the expected range repeat the test If you are unable to resolve the problem call your authorized LifeScan representative Example 5 6 mmol L CONTRL 7 52AM 1 06 00 Example 21 TESTING YOUR BLOOD DETAILED TEST PROCEDURE Choose a clean dry work surface Make sure you have all the items needed to test Release Button Ejection Cocking Control Depth Adjustment Knob Cap Depth Settings Depth Indicator Penlet Plus Adjustable Blood Sampler C M Meter One Touch Test Strip Sterile Lancet 22 CAUTION To reduce the chance of infection Never share a lancet with another person Always use a new sterile LifeScan Lancet Lancets are for single use only The Penlet Plus Sampler should be used by only one person However in the event the sampler is shared with another person always use a new lancet and a new or disinfected cap Avoid getting hand lotion oils dirt or debris in or on the lancets and the Penlet Plus Sampler GETTING A DROP OF BLOOD Step 1 Insert a Lancet into the Penlet Plus Adjustable Blood Sampler To remove the Penlet Plus Cap twist the cap counterclockwise Insert a lancet into the lancet holder Push down firm ly until the lancet is secure in the hold er Do not twist the lancet For best results and safety use only LifeScan lancets Note To reduce the chance of c
35. ystem Software 69 SPECIFICATIONS WARRANTY Five Year Warranty If at any time during the first five years after purchase the meter does not work for any reason except for obvious abuse LifeScan will replace it with a new meter or equivalent product free of charge The warranty policy applies only to the original purchaser of this meter and does not include the batteries supplied with the meter Before you return your meter or any product call your authorized LifeScan representative Please complete the warranty service card and mail it to LifeScan The One Touch Profile Meter has a full five year warranty from the original date of purchase Write your date of purchase here The warranty policy does not apply to the performance of the One Touch Profile Meter when used with any test strip other than One Touch Test Strips or when the One Touch Profile Meter or One Touch Test Strips are changed or modified in any way This warranty is in lieu of all other war ranties express or implied including any implied warranty of merchantability or fitness for a particular purpose 70 SHORT Short insulin INTERM Intermediate insulin LONG Long insulin XLONG Extra long insulin 30 70 Mixture 30 Short and 70 Intermediate and 50 50 Mixture 50 Short and 50 Intermediate MIXTUR Mixture other than mixtures identified OTHER Other insulin types not specified BOLUS Insulin pump setti
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