prety ll \ ACCU-CHEK* Performa BLOOD GLUCOSE METER Owner's Booklet AZ Whether the Aocu-Chek Performa Meter your fst blood glucose meter or you have used a ‘moter for some tine; please tale the time to read this booklet carehily before you use your new meter Touseit correcty and dependably, you need to understand ts operation, screen displays, and al indivival features. ‘Should you have any questions, please call the Accu-Chek Eugiy Line on 1800 251 816. The Accu-Chek? Performa System ‘Your new Accu-Chek Performa Meter is for quantitative blood glucose testing using Accu-Chek Performa test stp, ‘Suitable for self-testing. ‘The Accu-Chek Performa meter may be used by patients who test thelr own blood glucose aS well as by healthcare professionals for monitoring patent's blood glucose values. The system includes: ‘© Accu-Chek Performa Meter with battery + Aca-Chok Performa Test Strips and code chip '* Accu-Chek Performa Control Solution Any object coming into contact with human blood is a potential source of infection A (ee: Clinical and Laboratory Standards institute: Protection of Laboratory Workers ‘from Occupationally Acquired infections; Approved Guideline — Third Edition; CLSI document M29-A3, 2005). Why Regular Blood Glucose Testing Is Important Testing your blood glucose regularly can make a big difference in how you manage your diabetes everyday. We have made tas simple 2s possibieImportant Information About Your New Meter '* Your new meter is designed for testing fresh whole blood samples (for example, blood ‘from your fingertip or forearm). The meter is for outside the body (in vitro) use. It should nit bo usod to dagnese dabotos '* This meter requires Accu-Chek Performa Test Strips, Other test strips will give inaccurate results. ‘+ Your now motor comes with a prosot timo ané date. You may nood to chango the timo to ‘your time zone. * Ifyou have followed the steps in the booklet, but sill have symptoms that do not seem to match your tastresults—or if you have questinss—talk to your haaltheare professional Contents QL... “The Accu-Chek Performa Meter Coding Your Meter ‘Acjusting the Time and Date—Fist Time lise Using the Accu-Chek Performa System Flagging Test Results. Altornative Sito Testing (AST) Chapter 3: Meter Memory, Setup, and Downloading Memory Setting the Time and Date ‘Setting the Alarm Clock Function ‘Setting the Hypoglycemic (Hypo) Alarm Function Downloading Your Results to a Computer or PDA. Wy Perform Control Tests.. ‘About the Control Solutions. Performing a Control Test Understanding Control Test Resuts. inc Chapter 5; Maintenance and Troubleshooting Changing the Baty eenrnnuoneenonennninnn Geaning YU Mele. ercrnsvncronnn Maintenance and Toublesheating Soreen Messages and Troubleshooting Product Limitations... Specticatis aon Product Safety infomatr Disposing of Your Meter... BUAFEMEE. nnn ‘AMditional SuppHAS enn Information for Healthcare Professionais Index... Een -. At Ad “AS 46 50 58 58 55 56 ST 64 64 “64 61 “67 “09 70 A 78Chapter 1: Understanding Your New System The Accu-Chek Performa Meter Display ~ Infrared (R) Window — Shows reat, toed to toner data messages and from the meter toa ress sed n computer FOL menor. owonset Baton - Right and Lett Tums the meron oF Arrow Butons ~ of and as optons Pres to eter Battary oor menony sdst Flip pen te tery seting, and scr too by pushing the through eit tab in the dectn of rasrpsit- thearow Inet et stp her = ode cp stot — inset coe chi ito this opening Golden Ent —> jon inatthic na ft the test stro into zz the meter. Tot inion sees ‘uch boot crop or cortro solution here, — Test strip Test Stip Container Control Solution Botte ‘On/ofSet Infrared (IR) Code Chip Battery — insert with ution Top View Window (for example) (4) sym! facing up.Coding Your Meter 1. Make sure tie meter 2 Tur the meter ove, 3, Remove the old code chip Is turnod off (i tore i ono in tho meter) and discard it 4, Turn the code chip over so the code 5. Leave the code chip in the meter number faces away from you, Push until you open a new box of test iCinto the meter until It stops. ‘strips. Notes: '* Do not force the code chip Into the meter — it is designed to go in the meter only ‘one way. ~" on the display, insert a onde chip in the mater. © Ifyou see a code"Adjusting the Time and Date — First Time Use Having the correct tine and date in your metar is important if you use the meter memory or Ifyou want to download your results to a compute. decrease _ increase 1, Prass and release @ to 2 Pressandrelagsa “@ or 3. Press and release @ to turn the meter on.The to decrease o set the hout The minutes, time ané date appearon increase the hour. Press ‘flash ‘thedispay. "Set-up" and and hold or ‘the nour fash, ‘down to serol faster, Ce: 4 Press and release or & Repeat n set am/pm, symbol appears. The time to adust no minutos, day, mont, and year and date are now sot Press @ tosstthe once oust he yea, 7. See Chapter 3 “Meier Maes press and hold @ until Set" to set other the fasing test stp optone Note: wren you installa new battery, the meier automaticaly prompts you to check the ‘time and date when you turn it on.Using the Accu-Chek Performa System * Only use Accu-Chek Performa Test Strips. * Be sureto check the expiry date on the ‘est strip container. Do not use the test + Replace the code chip every time you ‘open a new box of test strips. Strips ater that date . * Store the test stip contalnr and your Stree test tps inthe nga meter in a cool cry place, such as a bedroom * Chose the container tighty immedately So ater you eke atest stp out This habs * Swe Is Tet bs at 219 820. Do mt keep the test strips dry retigerate Tex + Donat apply blond or contol solution to + Use the test stp immediately ater you Pea ereeraenie te tet stipe youre to te A kitchen)! Heat and moisture can damage your test strips. Chapter 2: Testing Your Blood Glucose Performing a Blood Glucose Test Botore you performyour fist Hood test, set yp your meter correct. You need the meter, a on ‘ost strip, and a lancot dovico witha lancot leaded. = 4. Wesh and dry your hands. 4. Make sure the code number on the 2. Propare your lancet dav. display matches the code number on the ‘3. Insert a test strip into the meter in the ‘snp exer. yal mas aN the code number, remove the tast strip dliection of the arrows. The meter turns on savour las be maticome ieit eal or ‘low Phe «, x cee} o 5. A lest strip and 6. Perform a fingerprick with your lancet device. Blood samples flashing blood drop ‘taken from the palm are equwvalent to blocd taken from the ‘symbol appear on ‘fingertp. For detailed Information on how to obtain blood ‘the display. ‘from the palm refer to the Alternative Site Testing section steps 5 and 6. ea 7. Gently squeeze your finger to assist the ut blood on top of the test strip. When flow of bood. This helps you get blood you see flash, you have enough blood drop. in the test strip. If you applied blood but do not see the flashhg = , you may 8 Touch the drop to the front edge of the eee reapply more blood within five secondsHSB 12-1 oo ‘9. Your result appears on the uisplay. you want flag your test result ora special ‘vent, leave the test stip in the mater. [See the nest section) Othernise, discard the used test strip, Note: after a successful test, the meter turns itself off five seconds after the tet strip is ramoved. Flagging Test Results It ypu wish, you can “flag” your test resutt with an asterisk (3 ) to indicate a special resut. You might wart to flag an event such as an AST result or exercise. When you review your g results in memory, this “flag” can help you remeriber vihat vas differant about the result. Here Is how to flag @ resut: 4. Perform a test. 2. With the test resutt on the display, and the tas strip STILL IN THE METER, press St or P once. The > appears in the wer right comer: ‘8. Remove anc discard the test strip. 28621 58Alternative Site Testing (AST) ‘You have the option of testhig other places on your body besides the fingertip. Blood obtained from ‘a fhgertip or palm —fleshy part of the hand under the thumb qhenar) and the Wtve finger (hypothenar) —can be used at ary time to measure blood glucose. tf blood from an altemative site — forearm, upper am, thigh, or calf - is used, there are certain times when testing Is not appropriate (see elon). This Is bacause your glucose level changes quicker in your fingertip or palm than in the alternative sites. These differences may cause you t make the wrong therapeutic decision producing adoro hath fee, Plo ead tho folowing soson teem yout testing fom other pcs ‘Altornative sito testing may bo done: “Immediately beore ¢ meal = Fasting 1O NOT test from an alternative ste “© Two hours or less after eating “Aer exercising “you are si IMPORTANT Talkto your heatheare professional about ‘Site Altematve Site Testing “blood glucose, -TLYOUT blood glucose does not match now ‘you feel, perform a fingertip/palm test to ‘confirm your result. If the fingertip/paim resus does not math how youted, Ifyou thnk your blood gucese is bw “* iHyou often dont notee wren your blood glucose is tow “* When best insulin is mast active "Afr injetng pid-acting isin (vo call your healthcare professional. ‘hours or bss) You need the meter, a test sirip, a lancet device designed for AST, and a lancet. ~~ EI 3. Make sure the code number on the display matches the code number on the tast strip container. If you miss seeing the code number, remove the test strip and reinsert it into the meter 1. Prepare your lancet device, 2. Insert a test strip into the meter in the direction of the arrows. The meter turns on,3a" 1211 Vv ee 4.Atedt strip andflashing 5. Press the lancet device 6, Trigger the ancat device blood drop symbol firmly against a fleshy while keering steady appear on the display, area on the alternative pressure cn the area. site, Press the lancet Apply pressure to the dovice up ard down ina area with the lancet slow pumping motion to ‘device to essist the fow assist the flow of blood, or blood. O30" 2-41 & 7.Touch the crop to the front edge cf tha do not see the lashing © , you may yellow window ofthe test strip. When Teagply more blood within ‘ive seconds, you sze % flash, you have enough blood Discard the used test strip. in the test strip. you applied blood but Note: ir the blood drop is too small, reapply pressure to get a suficent blood crop.Normal Blood Glucose Valu ‘These test strips are calibrated to deliver plasma-like results. The normal tasting blood glucose range for an adult without diabetes as related to plasma is 4.1-5.9 mmol/L. For people with dabetes: Please consult your diabetes team for he blood guicose range appropriate for you. You should treat your low or high blood glucose as recommended by your healthcare professional These test strips are plasma referenced in ine with the recommendations ofthe Intemational Federaton of Clinical Chemistry and Laboratory Medicine (IFC) Blood gluzoso eoneantrations may be measured in wholo blood or in plasma. Altrough you always apply whole blood to the test strip, when using these test strips your meter wil show rasuls that are equivalent to the glucose concentrations In pasta, Unusual Test Results If your blood glucase result does nat reflect the way you fee, follow those steps: Troubleshooting Checks Action Check the expiry date ofthe test strips. {Hitispast the exiry date discard the test strips. ‘Ensure that the cap on the teststrp Ifyou thinkit may have been uncapped for Container is abvays clase tight some ine, discard the test strips. Troubleshooting Checks Action 8.Check if the test strip was out ofthe Repeat the test with a new test strip. container for atong time. | ana and test again. f you stl have problems, call the Accu-Chek Enquiry Line on 1800 251 816, 6. Check that the code mmber on the meter | i they do not match, inset the correct code display matches the code munber on the est | chip in the meter and test again, “stip container. 7.lfyou arestit unsure ofthe problem... Repeat the test with a new test strip and run a control test. fyou stl have problems, call the ‘Accu-Chek Enquiry Line on 1800 254 816,Symptoms of High or Low Blood Glucose Being aware ofthe symptoms of high or low blooé glucose can help you understand your ‘est results end decide what to doi they seem urusual. Here are the most common symptoms: Han to ote roomate reed set ori oat aon, [ESI blurred vision, headache, or general acting. Low blood glucose (hypoalycemia}: sweating trembling, blurted vision, rapid heartbeat, tingling, or numbness around mouth or fingotips.. displayed as LO or your blood glucose result professional Immediately. Chapter 3: Meter Memory, Setup, and Downloading Memory Storing Test Results ‘our mater automatically stores up to 500 test results with the time and date of the tast. You can review then at any tme. Test results ae stored ftom the newest to the oldest It is very Important io have the correct time and date set in the meter. Having the correct time and ate setting helps ensure appropriata interpretation of blood glucose results by you and your healthcare team, Notes: + Donot change your therapy based on one nvidia esti merry '* The memory is not lost when you replace the battery. You do need to check that the time and date are correct after you replace the battery. '* Once 500 resufts are in memory, adding a new resut causes the oldest one to be deleted. ‘* Hoi! {or down to scroll though the resutts faster. '* The control results do not appear in memory. They are nct included n the 7, 14, and 30 day averages. '* The control resutts are stored in memory but cannot be reviewed cn the meter. The stored results ‘must first be downloaded to « compatible software application. For product availability, please contact Roche Diagnosties,Viewing Test Results Press either al or to entar memory Your most recent result aopears, Press «to viow provicus results in order. OR, press PF to look at your 7, 14, or 20 day averages. in that order. faa 00mm ie) Ragr B30" 211 50 mel Meter Setup Using the Set-up Mode By using the set-up mode, you can personalize your mater to su your Itestyle, Here are the features you can customiza— Time and Date—set the time and date Beeper—select “On" or “OFF” ‘Alarm clock—select 1-4 times a day for a reminder to tt Hypo alarm—select “On” or “OFF.” Ifyou choose “On,” choose the blood glucose leval for the aterm, Using the set-up mote is easy. The @ has three functions for the set-up mode, + With the meter on, press and hold @) to enter the set-up mode — about four seconds — Until “set-up” tlashas on the display. + Press and release @ to set the feature you have chosen. + You can exit the set-up mode at any time by pressing and holding @ for about four seconds. You sea the fleshing test strip symbol.You ar here TIME / DATE ‘hrs, min, arn/pm, day, monty yoar) ‘=> BEEPER =P ALARM CLOCK =>HYPO ALARM (onvofn 1A, A-2,A-3, Ad) (off, on, level) Setting the Time and Date eer 41.Press @ to tum the meter on. The flashing test strip symbol appears, \ decrease increase 3. Pressand release “i to decrease the hour. Press 2 Enter the set-up mode (press and Nold @® for about four seconds). and raleasa PP to “Sot-up” flashes on the increase the hour slisplay. The hour flashes. 4 Press and release @ to set the hour. ‘The minutes Pash, decrease » 5, Press and release “or B® to adjust the minutes. Press @ to set the minutes. increase Note: You can press and hold = or P° to scroll faster.oneetr 66. Repeat to set amipm, day, month and 7. you want to set up more options, year, press and relesse @. if you want to exit, press and hold @ untl the flashing test strip symbol appears. B ‘Your new meter has the beeper preset to “On.” You can sat the beeper tb “OFE” if you prefer You uP here TIME / DATE ==> | BEEPER | = ALARM CLOCK = HYPO ALARN {hs, min, am/pm, (ono (A4,8-2,8-3,A4) —_(off,on, level) ay, month yoar) Setting the Beeper On/Off ~ this wil not afect your tat resutts. ‘The beeper is helpful because t prompts you: ‘To apply blood or control solution tb the test strip ‘ WNhen enough biood or contre! solution is drawn into the test strip ‘+ When the test is complete + When a button is pressed ‘When it is tima to test df you set the alarm clack) ‘= an error occurred while testing (evenif the beaper is sat to oft stil beeps for an error)1.Prass @ to tur the meter on. The fashing test strip symbol appears. 38" 11" Enter the set-up mote 3. Press and release @ (press ané hold @ for repeatedly until you reach about four seconds). the display with the “Set-up” flashes on the flasting beeper symbol display. and “On, “ HYPO ALARM (hs, min, amipm, (on/off (AA, A2,A-3, Ad} (off, on, level) day, month yoar Setting the Alarm Clock Function “The alarm clock function fsa handy way to remind you to test You can sett to 4 slams per day. The meter beeps every two minutes—up to three tmes. You can turn the alarm off by inserting a test stip or pressing any bution. You must have te beeper sett “on” forthe alarm to sound. Your meter is preset with the alarm clock function set to “OFF” You must turn it “On” to use this feat. Ifyou turn A-1,A-2, 4-3, and A-4 on, your meter is preset with the following times for your convenience. You can adjust the times to sult your needs. At 8:00am — A-2 12:00pm (noon) A-3- 6:00 pm. A4 10:00 pm Notes: ‘+ I you tested withn 30 minutes of an alain, the alarm does not occur, ‘if the meter is on at the alarm time, the alarm does not occur. '* Exposure to cold conditons may disable alarms until the meter is turned on. When you are setting the time for the alarm clock function, the bell symbol remeins on the splay and ‘set-up” flashes continuovsly. 41. Press @ totum the 2 Enter the set-up made 8. Press and release @ meter on. The flashing (press and hold @ for Tepeatedly unil you reach test strip symbol appears, about four seconds, the display withthe bell ‘SeL-up" flashes on the symbol, “OFF” and the dlispay. flashing “set-up” and ie4 Press and release a or to solact “On” or “OFF.” Press and release w to set your choice, = 5. Ifyou select “On,” the hour flashas."A-1" and the bell symbol remain on the display. 6. Press and release or to sdoct tho hour, Press and release © to set the hour. 7. The minutes flash. Press and release a or P* to select 00, 15, 30, or 45, ‘These are the only choices, 8, Press and release @ to set minutes. “Am” oF ‘pm flashes on the display. Press “or to switch between am and pm. Press and release ® to set am or pm. 9.The next alarm *4-2" and “set-up” flesh on the dlispley with “OFF” and the bell symbol. You can either set a second alarm or press and hold @ Until you see the flashing test strip symbol to ext the set-up mode.Yovare here TIME /DATE = BEEPER = ALARM CLOCK —=>HYPO ALAR (hrs, min, am/pm, (on/off) (AA, A-2,A-3, Ad) (off, on, level) day, month year) Setting the Hypoglycemic (Hypo) Alarm Function ‘You can set the meter to lat you know when your blood | = | O38" 2-14 lucos2 is possibly oo low. You can also select what blood lucose leval you want this alerm to have 3.3 to 44 mmoVtL. Before you set the hypo alarm, talk to your healtheare Ptofessional to help you dactde what blood glucose leval is your hypo level. Your meter Is preset to “OFF” forthe hypo alarm. If you want to turn it “On,” follow these steps, 1. Press @ to turn the mmeteron. The flashing test stro symbol appears, idgem et 2. Enter the set-up mode 3, Press and release @ 4, Press and release ipreasand hold @ for repeatedly untl youreach Sor B® to owtoh about four seconts) the display with “OF” between “On” and “OF.” ‘Set-up” flashes onthe an the ashing “set-up” Press and release «@ to Aisa. and © set your choica5. you select the hypo alarm “On,” i “set-up” and © flash. The display. 7. Fress and hold @ until you see the ae % ‘lashing test strip symbol to eit the sat-up nde. Downloading Your Results to a Computer or PDA ‘You can transfer your stored results to a Infrared (R) computer to track, identify patter, and pri ‘Window Transferring Data 41.Tum off your meter. 2. Install the software according tothe instructions be 3. Connect the inflared meter cable to a 9-pin serial por connector on the back of your computer. 4. Run the software program and follow the instructions about how to download information, Make sure the software is ready to accept data from the meter, 5. Press and hold the © and BE on the meter until two arrows flash on the meter display. The meter is ready to transfer data6. Put the meter on a flat surface, and then align the infrared windows cn the meter and cable oF PDA they should be 3 to 10 cm apart 9. Follow the prompts on the software. 410. he software prooram may shutoff the meter automatically when the data transfer Is. complete, Notes: -* if the data did not transfer successfully, try again. If you still have problems, call the ‘Accu-Chek Enquiry Line on 1800 251 816. To make the most of the download feature, you must set the time and cate correctly. Chapter 4: Control Testing Why Perform Control Tests Performing a control test lets you know that your meter and tast strips are working properly to glve rolable results. You should perform a control tast whan: ‘You open a naw box of test strips * You left the test strip contaner open Bi ‘You want to check the meter and test strips * Your test strips were stored in extreme temperatures o humility * You cropped the meter * Your test result does not reflect how you fee! ‘ You nant to check if you are testing correctyAbout the Control Solutions > Only use Accu-Chek Performa Control Solutions. Close the battle tightly after usa Store the bate at 2 to 82°C Do not freeze, * Your meter autonatiealy recognizes the corr! solution + The control soluton results are not displayed in memory. Write the date you opened the bottle on the bottle label. The selution is good for three months ftom that date or unil the expiry date on the botle label, whichever comes frst Do not use control solution that is past the expiry date. The solution can stain clothing, if you spilt, wash your clothes with soap and water. Performing a Control Test direction ofthe arroves. The meter tums on 1. Inserta test stp into the meter inthe 2 You need the meter, a test strip, and control solution Level 1 and/or Level 2. The control level is printed on the bottle label. Make sure the cede number on the display matches the code number on the test stip container. Ifyou miss seeing the code numba, take the test stip out and roineert irto the moter.@& Bu 3. Selact the contrl solution 4, Putthe meter on aflat 5, Remove tha contro! battle you wart to test. You will surface, like a table, cap. Wipe tha tip of the enter the level later the bottle with a issue, test. om en 6 Squeeze the bottle unti a thy drop forms 7. Aresult appears on the cispay, along with atthe tip. Taueh the drop tothe front ‘a control bottle symibal end a flaching edige ofthe yellow end of the test stip. “L” Do not remmove the test strip yet. When yousee & flash, you have enough Press Be once to mark it as a Level 1 control solution inthe tast strip. Wipe the Ifyou tested the Level 2 contol, press ‘ip ofthe bottia with a issue then cap the Pa second time, bottle titty. ut o tw x uh 8 Press @ to sot the level in the meter, container label. Er’ and the control ‘9. “OK" and the contol result alternate on resut altemate on the display ifthe the display if the result is in range. The result is not in range. Remove the tast range Is printed on the test strip strip and discard it.Range (mmol/l) 17-34 44-195 Example ‘The lebel on your test strip container shows the acceptable ranges for both the Level 1 snd the Level 2 contol solutions. The result you get should be inside this range. Make sure you compare the resut to the correct level of control Understanding Control Test Results cs. Se= Example When the control result is Inside the range on the ‘est strip container, your taststips ‘and your metar are working properly. solve the problem: Troubleshocting Checks 1. Check the expity date of the test strips and control solution. ‘solution bottle before and atter use. container and the control solution bottio aro always closed tightly. container for along time, 2. Qheck thatyou wiped the tp of the contro! Ensure that the caps on the test stip A.Check if the test strip was out of the 5. Check thatyour test strips and control ‘solubions were stored in a cool, dy place. It your control rosult is nct inside the acceptablo rango, hore are some things you can do to Action if elther is past the expiry date, it. the contro soltion was opened more than three months ago, discard It rd Wipe the tip of the bottle with a tissue. Repeat the control test with a new test strip and a fresh drop of control solution. you think elther may have been ‘uncapped for some time, repiace the test strips or control solution. Repeat the control test with 2 new test strip. Repeat the control test with properly ‘stored test stlps or control solution.Troubleshooting Checks 6. Check that you followed the testing ‘stops contro! solution level, elther 1 or 2, ‘when you performed the test. ‘meter display matches the code 9.1f you are still unsure of the protiem.... 7. Check that you chose the comect 8. Check that the code number on the ‘number on the test strip container. Action Read Chapter 4 “Control Testing” and test again. If you still have probloms, call call the Accu-Chek Enquiry Line on 1800 251 816. Ityou chose the wrong control solution level, you can still compare the control result to the range printed on the test strip container. It they do not match, Insert the correct code chip in the meter and test again. Repeat the control test with anew test strip. If you stil have problems, call the ‘Acau-Chok Enquiry Line on 1800 251 816. apter 5: Changing the Battery of the arrow and pula the door up. Remove the old battery 1. Open the battery door on the back of the ‘meter by pushing the tab in the atraction 2. Insert the new battery wih the + side up. 3. Put ie battary door back in place and ‘rap it closedNotes: ** The meter uses one 3-voltithlum battery, type CR 2032. itis a good idea to have a spare battery avaiable. ‘© Be sure the battery goes in + side up or facing you. * After you change the battery, your meter prompts you to confirm the meter’ time and cata settings. All testresuits remain saved In memory. Cleaning Your Meter Caring for our Accu-Chek Perarma Metis ensy just keepit fee of dust. you need to clean it, follow these guidelines carefully to help you get the bast performance possible: Do Do Not Make sure the meter turned of *+ Get any moisture inthe cod chip slat '* Gently wipe the meter’s surface with a or test strip slot ‘soft cloth slightly dampened with one of | * ‘Spray any cleaning solution drectly these cleaning solutions: conto the meter + 70% isopropyl aleohol + Put ne meter under water or tiqu ‘water 10% household bleach solution (f partbleach plus 9 parts water) ‘made the seme day Make sure you squeez2 off excess figuid from the cloth before you ipa the mater's surfaceMaintenance and Troubleshooting Your metar needs litle or no maintenance with normal use. It automaticaly tests its own systems avery time you tum it on and lets you know if something is wrong, It you drop the meter or think itis not giving accurate rasutts, call the Accu-Chek Enquiry Line on 1800 251 816, To make sure the display & working properly, turn off the meter, then press and hold @ to see the complete display. all the segments should be clear and look exactly like the picture below. I not, call the Accu-Chek Enquiry Line on 1800 251 816. Screen Messages and Troubleshooting j ‘any concerts, please call the Accu-Chek Enquiry Line on 1800 251 816, Themeter willnot turn on or the dsplay is blank. + Battery is dead — Insert rew tattery * Display is damaged — Call the Accu-Chek Enquity Line Motor is defective — Call the Accu-Chek Enquiry Line +» Extreme temperatures— Move the meter ty a more temperate area= Tho motors roady for 38° 211) you to inset atest stip. = Battory power is bw. Change the battery eon, s: sehen: ——t psa The meter isin set-up ~ The meter is ready fora 838° 211 mode, waiting foryou to |238°" 211 | drop of blood or control change oF confirm solution, settings Bs) arm ea | Boo! luense may be This test rosutt was b 4 | higher than the tosge i211 | tagged, See Chapter 2 4) measuring range of the lagging Test Resuts' t) sstm, ‘or more datas mK [5] Blood alucoso may bo 38° 8 | lower than the 4 FY measuring range oF me Lo Lg) systemBlood glucase BOE UL | is below the defined hypo (iow tiooa lucose) level ‘The test strips will expe at he end of the current month, Before the end of the month, insert a naw code chip from a new box of test damaged. Pamove the test stip and rehsertit, or replace ttf damaged. Ifthe message Teappears, call the ‘Accu-Chek Enquiry Lina. The cote chip is Incorrect. Turn of the meter and insert a new ccede chip. I this does not fix the problem, call the Accu-Chek Enquiry Lune, E-3 mer 24 E-4 o~+ = strips and ensure the code chip number matches the code number on the tet stip container Maks sure Tignes the time and date inthe Bi oan 2-11 | not coded or meter are correct je we the cade chip ist inserted. Turn off the meter ie and recode It owe eu | Te tststens own ai] Motor eeuned ‘uring the test Discard the test stip and repeat the test. Not enough blood or contol solution was ‘drawn into the test stip for measurement or was appliad after the test has started. Discard the test strip and repeat the testThe code chip fs trom Aan elactronic error occured ae ie) anewpited bt ot est — EP" S| or, rare cases, a used tst eo (| stnps. ensure the cone ed stip was remored and cchip number matches | ‘einserted. Turn the meter the code munbar onthe off and on, oF take the Seade=_| test stip container. battery out fora few Make sure the tine and seconds and reinsert i date inthe meter are Perform abloot glucose ar coroct cont test I the problem petsists, call the Acci-Chek Engi Lie Blood or control solution was appliad to the test strip before the lashing crop appeared on the display. Discard the test and 44°C, wait five strip and repeat the minutes and repeat the test test. Do not artificially heat or cool the meter, The temperature is above or below tho propor ranga for the meter (6 to 44°C). Move to an area between 6 ao" The battery is almost ‘The time and date 0:36" 12-11 | ut of power. Change settings may be te battery now. incorrect. Make sure the - time and daie are correct and adjust, necessary, Note: * Ifyou s00 any thor enor seraon, ploaso call your local Rocko Diagnostes organisation.Chapter 6: Technical Information Please read the literature packaged with your test strips to find the last information on product spaeificaons and tmitations. Blood volume ‘Sample type Measuring time Measuring range Test stip storaye conditions ‘eter storage conditions 05 pL Fresh whole blood 5 seconds 10 to 600 mai (06 to 22.3 mmol 20300 Tempercture: 25 to 70° ‘System operating conditions 6 to 44%; 10 to 90% relative humicty Relative humidity operating ran toto 90% Memory capacity 500 resuts with time and date ‘Automatic power ott 2 minutes Power supply Ore 3-votItium battery ¢ype CR 2032) Displry LCD Dimensions 9982 22 mm (LH) Weight Approx. 62 g (with battery) Construction Hand-eld Protection cass Ml Metertype The Accu-Chek Performa Meter issuable Control solutin storage conditions Electromagnetic Compatibility ‘or continuous operation rte aee ‘This meter meets the electomagretc inmunty requirements as per ISO 15197 Amex A. The chosen basis foralectrostatic discharge immunity testng was basc standard IEG 61000-4-2, In ation, it masts the eletromannetic emissions requirements as per EN 61326. It's electromagnet emission i thus low. Interference fom other electrically dtven equipment isnot tobe anticipated, Performance Analysis ‘The perfsrmance date for he Accu-Chek Performa system (Accu-Chek Performa meter with AceU-Chek Performa test sips) were obtained using capilary bond from diabetic patents (method comparison, accuracy, vercus blood repeat) end corrol sltion Pepreduciblity) The sytem is calibrated ‘wit venous blood containing various levels of lucas. The reference values are obtained using the hexokinase method. For mehod eompaison, fe reuts were ccmpared with resus obtained using ‘the hexokinase method with deprteniston (automatic analyz). The hexokinase method is traceable ‘oan NST standard. The Accu-Chek Performa system meets the ISO 15497 requirements.‘Measuring Principle ‘The enzyme on the test strip, glucose dehydrogenase, in the presence of the coenzyme (P0Q), converts the alucose in the blood samp to gluconolactone. This eaction creates a hamiless DC electrical current that your meter interoretsfor your blood ghicose, The samole and enviconmental conditions are ao evaluated using a smallAC signal Blood gluoase concentrations may be measured in whole bloo¢ or plasme. Although you always epply whole blood to the test strip, your meter disolays blood glucase results that relate to plasma. Plaase refer io the package insert fr information on how the system Works, 01 the test principle and on referanca methods, Product Safety Information Stong elactramagretic folds may interfere with the proper operation ofthe meter, Do not use this mete clos» to sourees of strong electiomagnetic radiation. Toavoid lectostatie discharge, donot use the meter ina very dry environment, especialy ‘ona in which synthetic matorils are prasant. Disposing of Your Mete! During blood glucose measurement the meter itself may come nto contact with blood. Uoed meters therefore cary arak of infection, Peace dcpoce of your uoed meter ~ afer removing the battery — accordng to the regulations applicable fh your country. For information about correct disposal please contact your local couneil and authority. ‘The meter fals outside the soope of European Directive 2002/95/EC (Drenve on waste electrical and electronic equipment (WEEE)Explanation of Symbols ‘You may encounter the folowing symonls on packaging, on tha type pla, and in tha Instructions for your Accu-Chek Perfoima meter, shown here with hair meaning > o Eqg@ XO Please consult instructions for use Caution (refer to accompanying documents). Please refarto saity-related notes in the marual accompanying this instrument. Use by (unopened or cpened tast strip container) Store at IFCC plasma referenced (strps) Dispose in domestic waste Manutacturer PEF Catalogue number wD] For in vitro diagnostic use. Do not ingest! CE oss This product fs the raquitements of Directive 98/79/66 on in to Aiagnostic medical devices, Qe sted by Underwriters Laboratories, Ine. In accordance with UL 610104-1 and CAN/CSA 622.2 No.1010-1 3V type 2032 Guarantee ‘The statutory guarartee provisions governing the sale of consumer goods in the country of purchase shall prevailAdditional Supplies ‘The following supplies and accessories are available from, Diabetes Australia, pharmacies, or your surgical euppi: ‘Accu-Chek Performa Test Strips Accu-Chek Performa Control Solutions: ‘Accu-Chek Softclix Lancing Device ‘Accu-Chek Softclix Lancets ‘Accu-Chek Multiclix Lancing Device ‘Accu-Chek Multiclix Lancets: References 1. Stedman, Thomas Lathrop. Stedman's Medical Dictionary, 27th Eaition, 1999, pg. 2082. 2.D'Omnzio et a: FCC Recommendation on Reporting Blood Glucose Results; Clinical Chemistry 61:8 1573-1576 (2005). Information for Healthcare Professionals A appropriate for your facity ‘A trop of fresh, wtole blood i recuredto perform a blood gucos® test Fresh venous, capillary, arial, or neonatal blood may be used. Caution shouldbe taken to clear arterial nes before blood is drawn. Caution shouid be exercised in the interpretation cf neanats blood glucose values below 2.8 mmoV/L blood glucose determination with venous or arterial blood must be performed within 30 minutes of sample collection. Avoid air bubbles wit the use of pipettes. Fresh venous. blood specimens contahing the anticoagulants EDTA or heparin are acceptable. latoacetate or ‘luoride(oxaate are not recommended, Decisions about winether to recommend altemative site testing (AST) should take into accourt the motivation ard knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST. Ifyou a considering recommending AST for your patients, you need to understand tat there i a potential fora significant ference between fingertip /palr and alternative site blood glucose test results. The difference fh capillary bed concentration and blood perfusion throughout the body can lead to sample ste-to-stediferences in glucese results. These physolozcal effects vary between nviduals and can vary within a single individual based upon his or her behavior and relative physical contin, Our studiesinvolving altematve site testing of adults with dabetes show that most persons wil find their glucose vel changes more quickly nthe fingers palms’ blood than the alternative sites’ blood." This is especially importart when ghicose avela are falling cr rising rapidly. your patient fa used ‘o making treatment decisions based upon fingetip/paim readings, he or she shoul consider the delay, of ag-time, afecting the reading obtained fom an alternative site. Data on fle Index alarm clock function, setting, 35 alternative site testing, 19,71 appetite, increased, 25 battery, changing, 53 battery, installing, 53 battery, type, 8 beeper, setting, 32 blood glucose, testing, 14 blurred vision, 25 button, on/offiset, 7 code chip, 8, 9 computer, connecting your meter to, 42 control solution, 45 control test, acceptable range, 50 control test, performing, 46 control test, results, 50, contro tst results, Understanding, 50 control test, unacceptable range, 50 display check, 56 error messages, 87-63 expiy dite, 13,46, fatigue, 25 flagging test resus, 18 frequent urination, 25, quran, 69 high blood alueose, 25 hyperalyoamia, 25 hhypoglyeemia, 25 hhypoalyceric alarm function, satting, 39 low blood gluease, 25 ‘mairtenance, meter 56 memory, metas, 27 umoness, 25 product liitatons, 64 product specifications, 64 professiotal caregivers, 71 rapid heartbeat, 25 sattings, meter, 28, supplies, 7sweating, 25 symbos, 68 ‘echnical information, 64 ‘est rasuts, unusual, 23, ‘est strips, Azcu-chek Performa, 8,13 thirst, increased, 25, time and date, setting, 29 tingling, 25 ‘trembling, 25, ‘troubleshooting, 67-63, ‘stall Ptent Nes, 738825 and 691160, Austala Patent No, 5911605 lease fom Cudrart Holdings Cambridge Limted Distributed by: Roshe Diagnestios ‘stall ly Ltd 31 Vitoria Ave, Castle Hl, Atala NSW 2154 ACCU-CHEK® Performa tal 2 Dawa Bb 0.68298 Manaein, Germany wees Ivo] C Eos Made in USA ‘ACOUL-CHEK and ADCU-CHEK PERFORMA are trademarks of Foche, (©2006 Foctie Diagnostics lights reserved. 04861012001-1000