Lifescan OneTouch Profile blood glucose monitor manual

™ ™ Owner’ s Booklet Complete Diabetes T racking System For diabetes and life.[...]

CA UTION Befor e 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 pr ofessional. The One T ouch ™ Pr ofile ™ System is intended for use outside the body (in vitro diagnostic use). I t should be used only for[...]

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 R[...]

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 measure 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 Perf[...]

INTR ODUCTION The One T ouch ™ P rofile ™ Glucose M onitoring System is for people with diabetes who need to check the level of glucose (sugar) in their blood. T o per- form a blood glucose test, a One T ouch ™ T est S trip is inser ted into the meter and a small sample of blood is applied to the test strip . The meter then measur es the bloo[...]

PRECA UTIONS AND LIMIT A TIONS • 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 ignore physical symptoms without[...]

ONE T OUCH ™ PR OFILE ™ BL OOD GL UCOSE METER S tudy this diagram to become familiar with all of the par ts of your One T ouch ™ P rofile ™ M eter . 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 memor y . Y our test results will be dis- played here. M Button. The One T ouch ™ P rofile ™ M eter automatically stores your test results. U se the M button to recall the i[...]

ONE T OUCH ™ 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 NO TE: Y our test strip may look like THIS Consult your test strip package insert for specific test st[...]

IMPOR T ANT TEST STRIP INFORMA TION • 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 º C (86 º F). Do not refrigerate or place in direct heat or sunlight. • DO NOT use One Touch Test Strips beyond the expiration date on the vial. • DO NOT use One Tou[...]

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 sur e you set the code: • Befor e using the meter for the first time. • E very time you change to another vial of test strips. Check that the code number on the display matches the code number o[...]

S tep 2: Match the Code N umbers. 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 S tep 3 to code the meter . S tep 3: Code the Meter . After the word INSER T is dis- played on the meter , press and r elease the C button; the code number will appe[...]

I t is ver y important that you do the fol- lowing two simple checks r outinely to make sure y ou get accurate results. CHECK STRIP TEST A purple and white check strip is included in your meter case. Befor e doing a check strip test, make sure the test strip holder , test area, and check strip are clean, dry , and lint-free. D o the check strip tes[...]

S tep 1: T urn on the meter . The code number will appear on the display . N ext, INSER T CODE 10 (for example) STRIP will appear . S tep 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, W AIT PLEASE appears for a mo- ment. S tep[...]

The display will show ✓ OK if your r esult falls within the correct check strip range printed on the back of your meter . If the r eading is not within the recommended range, the meter display will show ✓ NO T OK REDO ✓ . Repeat the check strip test until your r esult falls within the correct range. S tep 4: T urn the check strip over and ins[...]

IMPOR T ANT CHECK STRIP INFORMA TION • If your check strip r esult 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 corr ect range. • Make sur e both sides of the check strip are clean. If necessar y , wipe the check strip with a so[...]

CONTR OL SOL UTION TEST One T ouch ™ N ormal Control Solution is used instead of blood to tell you that the meter and test strips are wor king togeth- er properly . The control solution con- tains a known amount of glucose that reacts with a O ne T ouch ™ T est S trip. Do a contr ol solution test: • Before using y our meter for the first time[...]

IMPOR T ANT CONTR OL SOL UTION TEST INFORMA TION • U se only One T ouch ™ N ormal Control Solution. • Check the expiration date of the control solution. D o not use if expired. Recor d the discard date on the vial. D iscard the vial 90 days after first opening. • The control solution range printed on the test strip vial is for One T ouch N [...]

The control solution test follo ws the normal test procedur e, using control solution instead of blood. S tep 1: T urn on the meter . The code number , time, and date will appear . The code number should match the code number on the test strip vial. S tep 2: Insert a test strip. When INSER T CODE 10 (for exam- ple) STRIP appears, slide a test strip[...]

S tep 3: Apply control solution. After the test strip is in the test strip holder , W AIT PLEASE appears for a moment, then APPL Y SAMPLE appears. Shake the contr ol solution vial well befor e remo ving the cap and adding a drop of control solution to the middle of the test spot, co vering it completely . 19 C M N o r m a l G lu c o s e C o n tro l[...]

20 S tep 4: The r esult appears within 45 seconds. Compare the contr ol solution test result with the control solution range printed on the One T ouch ™ T est S trip vial. When the control solution test r esult lies within the control range, you ar e ready to test your blood. C M 100 mg/dL CONTRL. 7:52AM 1/06/00 Recor d control solution tests in [...]

21 TESTING YOUR BL OOD DET AILED TEST PR OCEDURE Choose a clean, dr y work surface. Make sur e 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 CA UTION: T o reduce the chance of infection: • N ev er shar e a lancet with another person. • Always use a new , sterile LifeScan Lancet. Lancets are for single use only . • The P enlet ™ Plus Sampler should be used by only one person. H owev er , in the event the sampler is shar ed with another person, always use a new lancet and a new[...]

23 S tep 2: Adjust Punctur e Depth. T wist the depth adjustment knob located at the end of the P enlet ™ Plus S ampler to desired puncture setting. S maller bumps are for shallow er pu nc - tures, while larger bumps ar e u s e d f or deeper punctures. Gently twist off the lancet ’ s protective disk. Make two full turns to ensure that the lancet[...]

24 S tep 3: Cock the P enlet ™ Plus S ampler . Slide the ejection/cocking contr ol back until you hear a click. If it does not click, the P enlet Plus Sampler may have been cocked when the lancet was inserted. S tep 4: W ash Y our H ands. W ash your hands with soap and warm water . W arm water stimulates blood flow to the fingers. Rinse and dry h[...]

25 • Choose a spot on the side of a different finger each time you test. R epeated punctures in the same spot may cause soreness and calluses. S tep 5: Get a Drop of Blood. H elpful tips: • T o increase blood flo w to your finger- tips, massage the hand from the wrist to the fingertip two or three times without touching the puncture site. • H[...]

26 Gently massage your finger to obtain the requir ed blood volume. P roceed with your blood glucose test (see “S tep- by-S tep T est P rocedure ”, page 29). H old the P enlet ™ Plus Sampler firmly against the side of you r fi nger with the cap resting on y our finger . (G reater pressur e of the device against the finger will cause a deeper [...]

27 Optional: T o r eplace the protective disk on the lancet, place the disk on a har d sur face and push the exposed tip into the protective disk. Caution: Always use caution when r emoving the lancet. S tep 6: Remove the Lancet. T o remo ve the P enlet ™ Plus Cap, twist the cap counterclockwise.[...]

28 Return the ejection/cocking contr ol t o the middle position. Replace the cap. P oint the lancet down and away from you. P ush for ward on the ejection/cocking control and eject the lancet dir ectly into an appropriate container for sharp objects. CLEANING THE P ENLET ™ PL US SAMPLER • Clean the P enlet Plus Sampler with soap and water as ne[...]

STEP- BY - STEP TEST PR OCEDURE S tep 1: T urn on the meter . P ress the po wer 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 MC CODE 10 8:00AM 1/06/00 CODE 10 8:00AM 1/06/00[...]

WAIT PLEASE APPL Y SAMPLE S tep 2: Insert a test strip. N ext, INSER T 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 sur e you push the test strip in all the way until it stops. After W AIT PLEASE, the meter shows APPL Y SAMPLE. Y ou then have 5 minutes to ap[...]

Many times, the meter can detect if ther e is not enough blood and will show but you should also look at the test strip to make sure. S tep 3: Apply blood to the test spot Apply blood to the test spot so as to co ver it completely with a round drop . I t is ver y important that enough blood is applied. Do not: • S mear blood onto the test spot. ?[...]

32 Checking the amount of blood on the test strip. • Remo ve the test strip from the meter and look at the test spot. I t should still have a wet shiny drop that complete- ly co vers the circle. I f the blood sample has a dull, dr y appearance, you may not have applied enough blood or you may have smear ed it. • Look at the back of the strip . [...]

The meter displays results abo ve 600 mg/dL or 33.3 mmol/L as HI DANGER . A result that r eads HI DANGER means very high blood glucose (severe hyperglycemia). 33 Accur ate results in 45 seconds. The meter then counts down fr om 45 to 0 seconds, beeps, and displays your result. R emove the test strip only after the result is display ed. C M 106 mg/d[...]

T est results belo w 60 mg/dL or 3.3 mmol/L mean your blood glucose is low (hypogly cemia). IMPOR T ANT : If you get a HI DAN- GER result or a r esult below 60 mg/dL or 3.3 mmol/L and your test r esult does not reflect ho w you feel, follow the guidelines on pages 16-20 to ensure testing accuracy . Then repeat the test using a new test strip. Recor[...]

EVENT LABELLING Immediately after testing y our blood, you may want to mark y our glucose readings with ev ent labels. The One T ouch ™ P rofile ™ 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 • DUR[...]

I t will appear on the meter display with your test r esult, alternating with the time and date. 36 T o 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 pr ess the C button, a new event label will appear on the display . Hold the C button down to mo ve more rapid[...]

ENTERING THE MEMOR Y T urn on the meter . P ress the M button to enter the meter memor y . The word MEMOR Y will appear briefly . MEMORY MC The One T ouch ™ P rofile ™ M eter stores up to 250 test results with date and time. E vent labels and insulin recor ds are also stor ed. When the memor y is full, the oldest recor d is dropped as a new one[...]

The very first time you turn on your meter and press the M button, the fol- lowing message will appear , sho wing that there ar e no results stored in the memory: RECALLING RESUL TS T urn on the meter . P ress the M button to enter the memor y . P ress the M button again and again to see each of your blood glucose, check strip , control solution an[...]

Y ou can change or add event labels or insulin information stored in memory while they are display ed on the meter . T o delete an insulin recor d, simply select ‘00’ for the units. See pages 35 on ev ent 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 gl[...]

SET -UP OPTIONS MODE Y ou can change, or in some cases turn off, 11 features of y our One T ouch ™ P rofile ™ M eter to suit your individual needs. • Beep prompts •T i m e • Date • Ev ent averaging • Insulin prompt • Insulin programming • Display language • T ime format • Date format • U nit of measure • Decimal separator [...]

• U se the M button to scroll through the options or mo ve 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 mo ve to the next option. N ote: Y ou can exit the options mode at any time by turning off the meter . If after [...]

BEEP PR OMPTS The One T ouch ™ P rofile ™ M eter uses beeping tones to signal various steps in the meter procedur es. 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 pro vide beep prompts dur- ing the test p[...]

TIME AND DA TE In the set-up mode, use the M button to choose the T ime option. The current time will show . P ress the C button to change the time; the hour and AM or PM will flash. P ress the C button again to advance the hour to the corr ect set- ting. N ow pr ess the M button and the minutes will flash. U se the C button to change the minutes. [...]

EVENT A VERAGING In the set-up mode, use the M button to choose the event averaging option. P ress the C button to turn on the event averag- ing option. ON AVG M-MOVE C-CHANGE OFF AVG M-MOVE C-CHANGE 44 A verages for each event ar e displayed by pressing the M button to mo ve from one event to the next. A verages for up to 15 separate events, and t[...]

S tep 1: Change the insulin type. When a type of insulin, SHOR T for example, is flashing on the meter , press the C button until y our first type of insulin appears on the display . 00 UNITS SHORT M-MOVE C-CHANGE 00 UNITS INTERM M-MOVE C-CHANGE INSULIN PR OMPT Y ou can add information about your insulin type and dosage after each blood glucose tes[...]

S tep 2: Change the insulin units. When the units area is flashing ‘00’, pr ess the C button until your insulin dose is displayed. P ress the M button again and follo w the same steps to enter your second type of insulin and the dose. 00 UNITS SHORT M-MOVE C-CHANGE INSULN SECOND TYPE 00 UNITS INTERM M-MOVE C-CHANGE 45 UNITS INTERM M-MOVE C-CHAN[...]

After you have mo ved through each area, the complete r ecord will be dis- played for two seconds, follo wed by another insulin programming screen. Y ou may then press the C button to enter another insulin recor d. 47 CARBOHYDRA TE COUNTING Y ou can use the insulin programming feature to r ecord the number of grams of carbohydrate in your diet. F o[...]

The One T ouch P rofile M eter is pre-set to prompt you in E nglish. T o change the display language, enter the set-up mode. U se the M button to choose the display language option. P ress the C button until the language you want appears on the display . 48 DISPLA Y L ANGU A GE The One T ouch ™ Pr ofile ™ Meter can display messages in 19 langua[...]

DA TE FORMA T The meter is pre-set to display the date as month-day-year . F or example: J une 01, 2000 reads as 6-01-00. Y ou can set the meter to display day-month-year . T o change the date format, enter the options mode. U se the M button to choose the date format option. P ress the C button to change the date format. TIME FORMA T The meter is [...]

DECIMAL SEP ARA T OR 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 . 0.0 mmol/L DEC PT M-MOVE C-CHANGE 0,0 mmol/L COMMA M-MOVE C-CHANGE 50 T o change the decimal separator , enter the set-[...]

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 decilitr e (mg/dL). Y ou have the option to select millim[...]

The display messages that appear on your One T ouch ™ P rofile ™ M eter will guide you through testing procedur es, aler t you to any problems as they occur , and give y ou informa- tion about test results stor ed in the meter’ s memor y . This section provides y ou with a com- plete listing of the display messages, what they mean, and what t[...]

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 b[...]

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 Your blood glucose test result is 60 mg/dL (3.3 mmol/L).The message DO YOU NEED A SNACK [...]

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 a[...]

When any of the following messages appear , ther e is a problem with your One T ouch ™ P rofile ™ M eter or the way in which you are performing a test. I n most cases, problems are easy to fix. I f you still have tr ouble, call your authorized LifeScan repr esentative. ERR OR MESSA GES PROBLEM When this symbol appears and stays on the screen, i[...]

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 dr[...]

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[...]

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 [...]

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 acc[...]

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 [...]

T o keep your One T ouch ™ P rofile ™ Blood G lucose Meter in good operating condition, follow these simple rules: • Keep the test strip holder and test ar ea 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 [...]

CLEANING THE METER DO A DAIL Y CHECK: Look through the small hole in the test strip holder to make sure ther e is no lint, dir t, or blood blocking it. If ther e 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 b y following the instructions given belo w . Then [...]

S tep 2: Clean the test strip holder . W ash the test strip holder with soap and water . Clean the underside of the test strip hold- er . U sing a cotton swab, clean the small hole to remo ve any dirt, blood, or lint. Rinse well. Dry completely with a soft cloth or tissue. S tep 3: Clean the test area. Check the clear , protective coating o ver the[...]

Rub the test ar ea with a cotton swab or soft cloth dampened with water to remo ve all blood, dirt, or lint from the test area. I f necessar y , a mild liquid dish washing detergent mixed with water may also be used. Do not apply full- strength detergent to the test area. B e careful not to scratch the test area. D r y the test area with a soft, dr[...]

P ress forward on the base of the test strip holder to be sure it is pr operly in place. Y ou are now r eady to do a check strip test. If the check strip will not slide into the test strip holder , repeat S tep 4. REPLACING THE BA TTERIES The One T ouch ™ P rofile ™ M eter comes with batteries already installed. When the batteries need to be re[...]

When BA TTR Y` REPLACE NO W appears flashing on the display , the meter will no longer give results and y ou must replace the batter- ies before y ou can perform another test. Dead batteries or battery remov al will not affect the information stored in the meter memor y . The time and date will be saved in the meter for appro ximately an hour witho[...]

S tep 3: Remove the old batteries. Remo ve the old batteries by gently slapping the meter against the palm of your hand. N ever tap the meter against a hard surface. S tep 4: Insert the new AAA batteries into the batter y compar tment. Make sur e that the plus (+) and minus (–) signs on the batteries are cor- rectly aligned. T o replace the batte[...]

P ERFORMANCE 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[...]

W ARRANTY Fiv e-Y ear W arranty If , at any time during the first five years after purchase, the meter does not work for any reason (ex cept for obvious abuse), LifeScan will replace it with a new meter or equivalent product fr ee of charge. The warranty policy applies only to the original purchaser of this meter and does not include the batteries [...]

SHORT Short insulin INTERM Intermediate insulin LONG Long insulin XLONG Extra long insulin 30/70 Mixtur e 30% Short and 70% Intermediate and 50/50 Mixtur e 50% Short and 50% Intermediate MIXTUR Mixtur e other than mixtures identified OTHER Other insulin types not specified BOLUS Insulin pump setting, insulin taken o ver baseline amount CARBOH Carbo[...]

1 995 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, Calif or nia 95035, U.S .A. U .S. and f oreign patents; other patents pending. IFD/OB/O TP Rev .: 02/2000[...]