ACCU-CHEK. Compact Plus. User s Manual BLOOD GLUCOSE MONITORING SYSTEM. Downloaded from manuals search engine

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1 ACCU-CHEK Compact Plus BLOOD GLUCOSE MONITORING SYSTEM User s Manual

2 On the packagng, on the type plate of the meter and on the lancng devce you may encounter the followng symbols shown below. They have the followng meanngs: Consult nstructons for use Cauton (refer to accompanyng documents). Please refer to safety-related notes n the nstructons for use accompanyng ths nstrument. Store at Use by / Expry date The explanaton of any other symbols can be found n the nstructons/ nserts, accompanyng components wthn the packagng. WARNING: Patents recevng pertoneal dalyss usng solutons contanng Icodextrn (e.g. Extraneal, Icodal) should not use the Accu-Chek Compact test strp. It could cause an overestmaton of glucose results. For sngle use only Sterlzed through rradaton Manufacturer Catalogue number Lot number IVD 0088 For n vtro dagnostc use Blood glucose meter: Ths product fulfls the requrements of Drectve 98/79/EC on n vtro dagnostc medcal devces. Lancng devce and lancets: These products fulfl the requrements of Drectve 93/42/EEC on medcal devces. AST cap: Ths product fulfls the requrements of Drectve 93/42/EEC on medcal devces. Last update:

3 Intended use Accu-Chek Compact Plus Blood Glucose Meter Meter for quanttatve determnaton of blood glucose values n fresh capllary blood usng Accu-Chek Compact test strps. Sutable for self-testng. The Accu-Chek Compact Plus blood glucose meter may be used by people wth dabetes to test ther own blood glucose as well as for blood glucose determnaton by healthcare practtoners n a professonal settng. Accu-Chek Softclx Plus Lancng Devce Lancng devce wth adjustable depth settng for obtanng capllary blood from a fngertp or earlobe and, when a specal AST cap s used, from alternate stes such as the ball of the thumb. The lancng devce s ntended only for patent self-montorng by a sngle person. It must not be used to collect blood n a multpatent settng as t does not ncorporate any features to guard aganst cross-nfectons. Healthcare professonals must observe addtonally the drectons n Chapter 10 Blood glucose testng n a mult-patent settng Informaton for healthcare professonals. Any object comng nto contact wth human blood s a potental source of nfecton (see: Clncal and Laboratory Standards Insttute: Protecton of Laboratory Workers from Occupatonally Acqured Infectons; Approved Gudelne Thrd Edton; CLSI document M29-A3, 2005). 4 Intended use Intended use 5

4 About ths User s Manual Please read ths User s Manual carefully and completely before testng blood glucose for the frst tme. If you have any questons, please call Accu-Chek Customer Care at (see Chapter 17). Ths User s Manual wll help you get to know your meter and lancng devce step by step. It wll provde you wth all the nformaton you need to operate and care for your meter and lancng devce and to deal wth any errors that mght occur. Remember that, n order to keep your meter and lancng devce n good workng condton, you need to follow the correct operatng procedures and also observe certan other nstructons. The meter and lancng devce are precson nstruments and mproper handlng can mpar ther operaton. Other symbols are used, too. They have the followng meanng: Ths symbol s a prompt for you to do somethng, such as turn the meter on. Ths symbol sgnfes a lst. Ths symbol sgnfes a lst wthn a lst. We recommend that you start by gettng to know all of the features of your meter and lancng devce (see Chapter 1.1 and 1.2). Try out all of the steps descrbed n ths manual, and also practce usng the meter and lancng devce. Ths User s Manual features three symbols to draw your attenton to mportant nformaton. Please read these ponts wth specal care. Ths symbol ndcates a possble rsk of njury or of damage to your own health or to the health of others. Ths symbol draws attenton to actons that could result n damage to meter or to the lancng devce. Ths symbol draws your attenton to mportant nformaton. 6 About ths User s Manual About ths User s Manual 7

5 Contents 1 Introducton The Accu-Chek Compact Plus blood glucose meter at a glance The Accu-Chek Softclx Plus lancng devce at a glance Man features Dsplay llustratons Intal steps before testng Checkng the contents Checkng the blood glucose unt Type plate Dsplay check Insertng or replacng the test strp drum Test strp drum use-by perod Indcaton of the number of test strps remanng Settngs Changng settngs General rules Turnng the meter on Settng the beep tone or Acoustc Mode Settng the brghtness of the dsplay Settng the year Settng the tme/date format Settng the tme Settng the date Settng the alarm clock functon Settng the hypo ndcator Testng blood glucose Preparng to test blood glucose Preparng the lancng devce Undockng the lancng devce from the meter Dockng the lancng devce onto the meter Insertng the lancet Performng a blood glucose test Turnng the meter on Obtanng blood Drawng up blood wth the test strp Ejectng the test strp Ejectng the used lancet Symbols you see before, durng or after testng and what they mean Flaggng specal results Evaluatng results Measurng range Implausble results possble causes of error Usng the meter as an electronc notebook Memory Retrevng results from memory Average, hghest value and lowest value for 7, 14 and 30 days Downloadng test results to a PC, handheld computer or a specal evaluaton system Contents Contents 9

6 6 Acoustc Mode Beep tones at power-on Beep tones durng testng Announcement of the result followng a test Announcement of results and average values from memory Announcement of warnngs and error messages Checkng your meter What you need Performng a performance check Possble causes of error durng the performance of performance checks Cleanng the meter and lancng devce Cleanng the meter Cleanng the lancng devce Changng the batteres Blood glucose testng n a mult-patent settng Informaton for healthcare professonals Replacng the lancng devce wth a blankng plate Performng a blood glucose test Dsnfectng the meter Sutable dsnfectants Measurement and storage condtons Temperature range Lght condtons Humdty Local sources of nterference Symbols, error messages and troubleshootng Symbols shown n the dsplay Sngle symbols Combnatons of symbols Symbols appearng n the numerc feld Interferences and error messages causes and troubleshootng recommendatons Techncal data Alternate ste testng Choosng the rght moment Obtanng blood and testng blood glucose Cleanng the AST cap Dsposng of the meter System components Patents Accu-Chek Customer Care Lne Advce and troubleshootng Addresses Alphabetcal ndex Contents Contents 11

7 1 Introducton 1 The meter s suppled wth batteres already nserted. The tme and date are already set. You may need to adjust these settngs to your own tme zone (see Chapter 3). 1.1 The Accu-Chek Compact Plus blood glucose meter at a glance Front Tp of the test strp where blood s drawn up Dsplay wndow S button Press ths button to change settngs. Recess for dockng the lancng devce Test button Use ths button only f you want to test your blood glucose or perform a performance check, or wsh to turn the meter off. Pull the button downwards towards the drum compartment cover. The button tps downwards and the meter turns on. Ths pull-tp mechansm stops the meter from turnng on nadvertently. Drum compartment Drum release button Test strp gude Measurng wndow Test strp Test strp drum Drum compartment cover* M Button Press ths button to retreve results stored n the meter s memory. * avalable as replacement part 12 Introducton Introducton 13

8 1 Back 1.2 The Accu-Chek Softclx Plus lancng devce at a glance D C u B A v z w x y Battery compartment cover* Infrared wndow for sendng results to a PC, for nstance Batteres: type AAA, LR 03, AM 4, Mcro Battery compartment Type plate * avalable as replacement part Control wndow (shows the number of strps remanng) Lancng devce* Slde button for undockng the lancng devce u Plunger The plunger s a multfuncton button used to prme, trgger and eject the lancet. v Wndow showng the penetraton depth settng w Lancet holder x Lancet y Protectve cap on lancet z Pn-hole openng for lancet A Cap B Comfort Dal for depth selecton (you change the depth by rotatng the cap) C Locatng notch D Locatng lne 14 Introducton Introducton 15

9 1 1.3 Man features Docked lancng devce The meter comes wth an attached Accu-Chek Softclx Plus lancng devce. You can leave t docked onto the meter to collect blood or, f you prefer, you can undock t. Test strp drum nstead of ndvdual test strps You never need to touch a test strp. Smply nsert a drum wth 17 test strps nto the meter. Easy to operate Turn the meter on, apply blood, read the result, press the button to eject the test strp. Automatc codng Every test strp drum has ts own bar code. The meter s automatcally coded whenever you nsert a new drum, a process whch provdes the meter wth nformaton on the specfc characterstcs of the test strps. Indcaton of the number of test strps remanng Each tme you turn the meter off, t shows you the number of test strps remanng n the drum. Relablty The meter checks each test strp. If t fnds a defectve strp, t lets you know before you apply blood. Blood volume checkng The meter can tell when you have appled suffcent blood (approxmately 1.5 μl (1 mcroltre = 1 thousandth of a mllltre)). It wats untl then before startng the test. If the test does not start, you may apply more blood. Alarm clock functon The meter can remnd you to test your blood glucose. You can set an acoustc sgnal to remnd you at three dfferent tmes. Hypo ndcator functon In order to look out for unusually low results you can set a hypo ndcator level (hypo threshold). If a result s below the level you have set, a symbol n the dsplay and an acoustc sgnal (provded t s set to on) prompt you to check your result carefully to see f you are headng towards a possble hypo (low blood glucose). Downloadng data to a computer The meter has an nfrared wndow. You can download results to a computer runnng the approprate software or to specal analyss systems. 16 Introducton Introducton 17

10 1 Acoustc Mode Acoustc Mode s ntended for persons who are vsually mpared. When Acoustc Mode s turned on, the meter gudes the user through the blood glucose test usng beep tones; t also outputs the result as a seres of beeps. For more nformaton see Chapter 6. Vsually mpared persons need a sghted person to nstruct them n the use of the meter and to assst them wth all aspects of ts operaton. Vsually mpared persons must not test ther blood glucose wthout assstance from a sghted person. 1.4 Dsplay llustratons Throughout ths User s Manual you wll see examples of what the dsplay looks lke. Any elements that are shown surrounded by a halo n these examples flash n the dsplay. Example: You have turned on the meter to perform a blood glucose test. In the dsplay you see the tme and date plus the test strp symbol and the drop symbol. The test strp symbol and drop symbol are flashng. The tme, date and blood glucose results shown n the dsplay llustratons are ntended only as examples. The numbers wll not necessarly be the same as those shown by your own meter. The meter that s used for llustraton n ths manual dsplays blood glucose results n mmol/l (see Chapter 2.2) and has been set to 24-hour format (see Chapter 3.6). Your meter, on the other hand, may dsplay the tme n 12-hour format. 18 Introducton Introducton 19

11 2 Intal steps before testng Checkng the contents Check that your meter kt s complete. The package contents are lsted on the box. If anythng s mssng, please call Accu-Chek Customer Care at Detals are gven at the end of ths User s Manual. 2.2 Checkng the blood glucose unt Blood glucose results can be dsplayed n two dfferent unts of measurement (mmol/l or mg/dl). Consequently, Roche sells two dfferent versons of the same meter. If you do not know whch s the rght unt for you, ask your doctor. Check that your meter dsplays the unt that s rght for you, n Canada mmol/l Type plate The type plate on the back of your meter ndcates whch unt of measurement your meter uses Dsplay check You can check the unt of measurement your meter uses by performng a dsplay check. Press and hold down the M button. The meter turns on. Whle you hold down the M button, you frst see the dsplay check. mmol/l meter or mg/dl meter Check the unt by referrng to the type plate and to the dsplay wndow durng a dsplay check (see the followng pages). Note The unt that your meter dsplays cannot be changed. If the wrong unt s prnted on the type plate, please consult your dealer or pharmacy or the Accu-Chek Customer Care Lne. Usng the wrong unt can cause you to msnterpret the test results. The unt of measurement s shown n the bottom rght corner of the dsplay. 20 Intal steps before testng Intal steps before testng 21

12 2 If you contnue to hold down the M button, you then see the followng dsplay after approxmately 2 seconds. mmol/l meter or mg/dl meter Notes If addtonal lnes appear durng the dsplay test or parts of the numerc feld or of a symbol are mssng, please call Accu-Chek Customer Care at If the numerc feld (mmol/l meter) or (mg/dl meter) s affected, the meter may not show your test results correctly. When you release the M button, your meter s n memory mode. As long as no results have yet been saved, three bars are dsplayed. The meter automatcally turns off after 60 seconds even f you keep the M button pressed. You can perform a dsplay check whenever you wsh. If there are results already saved n memory, the most recently saved result s dsplayed when you release the M button. Press the Test button to turn the meter off. 22 Intal steps before testng Intal steps before testng 23

13 2 2.3 Insertng or replacng the test strp drum Read the package nsert that came wth the test strp drums. If the meter s on, press the Test button to turn t off. Wat for the motor to stop. Set nto the bottom of the meter to the left of the lancng devce s a recess. The upper part of ths recess belongs to the drum compartment cover. Hold the meter n your rght hand and place the thumb of your left hand nto ths recess. Then pull the drum compartment cover wth your fngers slghtly to the front and lft t up. Drum compartment cover Recess Irrespectve of whether a test strp drum s nserted or not: Press the red drum release button. 24 Intal steps before testng Intal steps before testng 25

14 2 The pn holdng the test strp drum n poston retracts wth an audble CLICK. Insert a new test strp drum n the meter as llustrated (the two rows of bar code must be nearest the dsplay wndow). Close the drum compartment cover and push t shut. There wll be an audble CLICK. If there s a test strp drum n the meter: The meter turns on and rotates the test strp drum untl the frst test strp s n the correct poston. At the same tme the meter reads the bar code that provdes t wth nformaton on the specfc characterstcs of the test strps. After that, the meter turns off. Tp the meter forwards. The test strp drum drops out. 26 Intal steps before testng Intal steps before testng 27

15 2 A dot appears n the small control wndow on the back of the meter. Ths ndcates that you have just nserted a test strp drum. When you perform a blood glucose test, the meter counts the number of test strps that you have used. The number of strps remanng s dsplayed n the control wndow. If you do not nsert a new drum, the followng message appears the next tme you turn on the meter: and the drum symbol are flashng to ndcate that the test strp drum s empty. Product Lmtatons When all the test strps n a drum have been used up, the dot reappears n the small control wndow. Insert a new test strp drum. Notes Please read the lterature packaged wth your test strp drum to fnd the latest nformaton on product specfcatons and lmtatons. Use only test strps that are not beyond ther expry date. Test strps that have expred can produce ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. The expry date s prnted on the pack and on the peel-off label on the drum contaner next to the symbol. 28 Intal steps before testng Intal steps before testng 29

16 2 New test strp drums where the alumnum fol (the slver ends) s damaged cannot be used. Your blood glucose results may be ncorrect f you use a damaged drum. Incorrect results can cause the wrong therapeutc decson to be taken and so produce adverse health effects. Only open the drum compartment cover when the meter s turned off and the motor s not runnng. Openng the drum compartment cover when the meter s turned on may result n damage to the meter. Handle the test strp drums wth care! Only remove a test strp drum from ts contaner when you ntend to use t. The contaner protects the alumnum fol on the drum from damage. There s a label on every drum contaner. The left porton may be peeled off. On t s the concentraton table for the Accu-Chek Compact Autocontrol control solutons. The stated concentratons are vald only for the test strps contaned n ths drum. You need ths table for the performance check of your meter (see Chapter 7). You may, for nstance, wsh to stck the peel-off label n your notebook or dary. When conductng a performance check, always check that the peel-off label wth the concentraton table belongs to the test strp drum that s currently n the meter. If you nsert a partly used drum n the meter, the meter rotates the drum so the dot appears n the control wndow on the back. When you subsequently turn on the meter to perform a test and you have re-nserted a same drum you prevously removed: The meter mmedately rotates the drum to the frst chamber that contans a test strp, and ejects the strp.... you have used up the prevous drum or have replaced one partly used drum wth another partly used one: The meter may search all chambers untl t fnds the frst one that contans a test strp. The fewer test strps the drum contans, the longer the process takes. If the meter mmedately rotates the drum to one of the chambers near the end (you can tell by the nose of the motor that rotates the drum), the drum may ultmately stll contan test strps even though the meter regards t as empty. You can stll use the test strps by nsertng the drum agan. 30 Intal steps before testng Intal steps before testng 31

17 2 If you nsert a partly used test strp drum nto the meter, the meter cannot calculate the use-by perod for that drum. Consequently, the next tme you perform a test, the drum symbol and flashng bottle symbol are dsplayed to hghlght the fact (see Chapter 2.3.1). Use only Accu-Chek Compact test strp drums. Other test strps cannot be used to perform tests. If you nsert a dfferent test strp drum, error message E22 s dsplayed (see Chapter 12.2). Make sure that the drum compartment cover s tghtly closed. If t s not properly closed, the meter wll not turn on when you press the Test button. All you see s the dsplay check brefly. You can dspose of used test strp drums wth your regular household waste Test strp drum use-by perod When you nsert a new drum nto the meter, the meter starts to count the number of days the drum s n the meter. Each drum must be used wthn a 90-day use-by perod. Once a drum has been n the meter for 90 days, ts use-by perod has expred. The next tme you turn the meter on to perform a test, the drum symbol, bottle symbol and clock symbol are dsplayed to hghlght the fact. Insert a new test strp drum. Note The test strps n ths drum cannot be used. You must not use these test strps as they may produce ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. 32 Intal steps before testng Intal steps before testng 33

18 2 The meter s unable to calculate the 90-day use-by perod f you nsert a partly used drum n the meter, even f t s the same one you have just removed, the year, date and tme settngs are lost when you replace the batteres (see Chapter 9), and a partly used drum remans n the meter. The meter has no way of tellng you n these cases when the drum was frst nserted or how long the partly used drum has already been n the meter. If the meter cannot calculate the use-by perod and you turn the meter on to perform a test, the followng symbols appear n the dsplay: Flashng test strp and flashng drop, ndcatng that you may now apply blood or control soluton Drum, ndcatng that the use-by perod cannot be calculated Flashng bottle, promptng you to perform a performance check n order to check the test strps Perform a performance check (see Chapter 7). If the result from the performance check s wthn the stated concentraton range, you can stll use the test strps remanng n the drum. If the result s outsde the range, you need to nsert a new drum. Followng the performance check, the bottle symbol dsappears from the dsplay. If you do not perform a performance check, the flashng bottle symbol appears wth every test untl you nsert a new drum. The drum symbol contnues to be dsplayed wth each test n order to draw your attenton to the fact that the meter cannot calculate the use-by perod. All results are saved along wth the drum symbol. The drum symbol only dsappears when you nsert a new drum. 34 Intal steps before testng Intal steps before testng 35

19 Indcaton of the number of test strps remanng Each tme you turn the meter off wth the Test button, t shows you the number of test strps remanng n the drum. The number of remanng strps contnues to be dsplayed as long as you hold down the Test button. In ths example there are stll 12 test strps n the drum. If you have not performed a test snce last replacng the drum, the meter cannot tell how many test strps there are left n the drum. Ths s e.g. the case when, after you have changed the drum, you start by changng settngs or retreve results from memory. If you then press the Test button to turn the meter off, only three horzontal bars are dsplayed nstead of the number of test strps remanng. Only when you have performed a test wth the newly nserted drum does the meter dsplay the number of test strps remanng each tme you turn the meter off wth the Test button. When you release the Test button, the meter turns off. Notes If the test strp drum contans three or fewer test strps followng a test, the number, the test strp symbol and drum symbol flash n the dsplay wndow. If you press the Test button only brefly when turnng the meter off, the number of test strps remanng s dsplayed only brefly or not at all. 36 Intal steps before testng Intal steps before testng 37

20 3 Settngs You can change the settngs of your meter to turn the beep tone or Acoustc Mode on or off, to set the brghtness of the dsplay, to select the tme-and-date format, to set the year, the tme and the date, and to actvate the alarm clock functon and the hypo ndcator. Beep tone: When the beep tone s set to on, t provdes user support durng testng by markng the start of each step acoustcally. Acoustc Mode: When Acoustc Mode s turned on, the meter gudes you through the blood glucose test usng beep tones; t also outputs the result as a seres of beeps. Alarm clock functon: You can set the meter to remnd you to test your blood glucose. Hypo ndcator: You can set a personal hypo ndcator level. If your result s below ths level, the meter alerts you to the fact that you are possbly headng towards a hypo. When you turn the meter on for the frst tme, t has the followng presettngs. These are factory defaults that you can change. Beep tone on, Acoustc Mode off Brghtness of the dsplay: medum Year: current year, e.g Tme-and-date format: 12-hour or 24-hour format; 12-hour format s assocated wth the date format month-day (MM-DD) 24-hour format s assocated wth the date format day-month (DD-MM) Tme: current tme based on Eastern Standard Tme (EST) Date: current date based on Eastern Standard Tme (EST) Alarm clock functon: off Hypo ndcator: off 3 The meter s suppled wth batteres already nserted. The tme and date are already set. You may need to adjust these settngs to your own tme zone. You can perform blood glucose tests wthout adjustng any of the settngs. All settngs are the default factory settngs (see next page). Notes If the year, tme and date settngs were lost as a result of a battery replacement (see Chapter 9) and you fal to reset these, the meter dsplays the tme as 0:00 and the date as 0-00 (n 24-hour format as well as n 12-hour format) when you perform a test. In memory the results are saved not wth the tme and date but wth ther memory locaton number (see Chapter 5.2). Wthout the 38 Settngs Settngs 39

21 tme and date the meter s not able to calculate averages, nor the lowest and the hghest values (see Chapter 5.3). Results sent to a PC, for nstance, wthout the tme and date (see Chapter 5.4) cannot be statstcally analyzed or, f they can, then only to a lmted extent. If the year, date and tme settngs are lost as a result of a battery replacement, the meter dsplays the followng settngs: Year: year of manufacture 20XX, e.g Tme: 0:00 or 12:00 am, dependng on the tme-and-date format you selected prevously Date: 1-01 as day-month (D-MM) or month-day (M-DD), dependng on the tme-and-date format you selected prevously In the sectons set out below you wll fnd a descrpton of the general rules for changng settngs, descrptons of ndvdual settngs and how to change them. The descrptons of settngs proceed n the order n whch they appear n the meter. Beep tone or Acoustc Mode Tme Brghtness of the dsplay Date 3.1 Changng settngs General rules Year Alarm clock functon Tme-and-date format Hypo ndcator The appearance of n the dsplay wndow ndcates that the meter s n settngs mode and that you can change these Settngs Settngs 41

22 The procedure for changng the settngs s as follows: The settngs have a fxed sequence and are dsplayed consecutvely, see llustraton on the prevous page. Press the S button to call up the settngs. A test strp s not advanced. Press the M button to change the settng that s currently flashng. Numbers such as the year are ncremented by one. Pressng and holdng down the button ncrements the number quckly. From the hghest selectable number, pressng the M button automatcally takes you to the lowest one. In the case of settngs where there are a number of optons, such as the beep tone settng, pressng the M button presents each opton n turn. Press the S button to save the chosen settng and move on to the next settng. You can change any settng at any tme. Press the S button repeatedly untl the settng you wsh to change s dsplayed flashng. From the last settng Hypo ndcator pressng the S button takes you back to the frst settng Beep tone/acoustc Mode. You can close the settngs at any tme by pressng the Test button. All settngs you have entered up to that pont are saved. Notes Always turn the meter on wth the S button when you ntend to change the settngs. Instead, f you turn the meter on wth the Test button and there s a drum n the meter, a test strp wll be advanced. If you turn the meter off wth the Test button, t shows you the number of test strps remanng n the drum (see Chapter 2.3.2). The meter turns off automatcally after approxmately 60 seconds f you do not press a button. All settngs you have confrmed up to that pont wth the S button are retaned. Settngs that you have not confrmed wth the S button are lost and the orgnal settng remans Settngs Settngs 43

23 3.2 Turnng the meter on 3.3 Settng the beep tone or Acoustc Mode You are here 3 Beep tone or Acoustc Mode Brghtness of the dsplay Year Tme-and-date format On / Off / Acoustc Mode Low / Medum / Hgh 24-hour / 12-hour Tme Date Alarm clock functon Hypo ndcator Hours, Mnutes Month, Day Off / 1, 2 and 3 (hour, mn) Off / Level Ths settng enables you to turn the beep tone on or off and to actvate Acoustc Mode. Wth the meter turned off, press the S button. The meter turns on wthout advancng a test strp. Followng the dsplay check (see Chapter 2.2.2) the current beep tone settng (symbol ) s flashng. When the beep tone s turned on, you hear a beep durng testng when the meter s ready to test so you can draw up blood or control soluton wth the test strp, when the test strp has drawn up suffcent blood or control soluton and test has started, when the result s dsplayed, when the hypo ndcator s turned on and the result s below the level you have set, when the meter dsplays an error message. 44 Settngs Settngs 45

24 There are two types of beep tone, dfferng n ptch. The ptch for a hypo ndcator or an error message s hgher than that heard n the other cases lsted above. When Acoustc Mode s turned on, the meter gudes you through the blood glucose test usng the beep tones mentoned above; t also announces the result as a seres of beeps (see Chapter 6). The beep tone s factory-set to on ( ). Beep tone turned on Press the M button to move to the next opton. Press the S button to save the chosen settng. The brghtness settng comes next. Notes When you select Acoustc Mode, you hear a beep. The beep tone settng has no nfluence on the alarm clock functon. If you have turned the alarm clock functon on (see Chapter 3.9), the meter wll always beep to remnd you to test your blood glucose even f the beep tone tself s turned off. 3 Beep tone turned off Acoustc Mode turned on 46 Settngs Settngs 47

25 3.4 Settng the brghtness of the dsplay You are here Medum brghtness (level ) 3 Beep tone or Acoustc Mode Brghtness of the dsplay Year Tme-and-date format On / Off / Acoustc Mode Low / Medum / Hgh 24-hour / 12-hour Tme Date Alarm clock functon Hypo ndcator Hours, Mnutes Month, Day Off / 1, 2 and 3 (hour, mn) Off / Level You can use ths settng to adjust how brght you wsh the dsplayed symbols and numbers to be. There are three brghtness levels: low, medum and hgh. The brghtness s factory-set to medum (shown by the at top rght of the dsplay wndow). Low brghtness (level ) Press the M button to move to the next opton. Hgh brghtness (level ) The brghtness of the dsplay wndow changes to the settng you have selected. Press the S button to save the chosen settng. The year settng comes next. 48 Settngs Settngs 49

26 3.5 Settng the year The tme-and-date format settng comes next. 3 You are here Notes Beep tone or Acoustc Mode On / Off / Acoustc Mode Tme Hours, Mnutes Brghtness of the dsplay Low / Medum / Hgh Date Month, Day Year Alarm clock functon Off / 1, 2 and 3 (hour, mn) Tme-and-date format 24-hour / 12-hour Hypo ndcator Off / Level The year you have set s not dsplayed durng testng, nor together wth the result, nor when you look at saved results n memory. It s only dsplayed when you are n the settngs. However, havng the correct year settng s stll mportant because wthout t the meter wll not be able to recognze February 29th n a leap year. The correct year settng s also needed to unambguously dentfy your blood glucose test results when you download them to a computer for analyss or further processng. The year that s currently set flashes at top rght of the dsplay. The year can be set from the year of producton to the year of producton plus 32. Press the M button repeatedly, or press and hold t down, untl the requred year s dsplayed. Press the S button to save the chosen settng. 50 Settngs Settngs 51

27 3.6 Settng the tme/date format You are here The tme-and-date format that s currently set flashes n the dsplay. If 12-hour format s the current settng, 12h wll flash n the dsplay. If 24-hour format s the current settng, 24h wll flash n the dsplay. 3 Beep tone or Acoustc Mode Brghtness of the dsplay Year Tme-and-date format On / Off / Acoustc Mode Low / Medum / Hgh 24-hour / 12-hour Tme Date Alarm clock functon Hypo ndcator Hours, Mnutes Month, Day Off / 1, 2 and 3 (hour, mn) Off / Level You can choose between two formats. In 24-hour format the tme s dsplayed from 0:00 to 23:59. If you select ths format, the date s dsplayed n the format DD-MM (day-month, no year). In 12-hour format the tme s dsplayed from 12:00 to 11:59 wth am or pm. If you choose ths format, the date format changes to MM-DD (month-day, no year). The tme-and-date format s shown together wth the current tme and the current date settng. If the format s changed, the way the tme and date are dsplayed also changes. Press the M button to change the tme-and-date format. If you press the M button agan, the orgnal tme-and-date format reappears. Press the S button to save the chosen settng. The tme settng comes next. 52 Settngs Settngs 53

28 3.7 Settng the tme 3 Beep tone or Acoustc Mode Brghtness of the dsplay Year Tme-and-date format 12-hour format On / Off / Acoustc Mode Low / Medum / Hgh 24-hour / 12-hour Tme Hours, Mnutes Date Month, Day Alarm clock functon Off / 1, 2 and 3 (hour, mn) Hypo ndcator Off / Level Press the M button repeatedly, or press and hold t down, untl the requred hour s dsplayed. Press the S button to save the chosen settng. The mnute settng comes next. You are here The mnutes flash at top left of the dsplay. The tme and the date that are currently set are dsplayed. The hour flashes at top left of the dsplay. 24-hour format 24-hour format 12-hour format 54 Settngs Settngs 55

29 Press the M button repeatedly, or press and hold t down, untl the requred mnutes are dsplayed. Press the S button to save the chosen settng. The date settng comes next. The month flashes at top rght of the dsplay. 24-hour format (DD-MM) Settng the date Beep tone or Acoustc Mode On / Off / Acoustc Mode Brghtness of the dsplay Low / Medum / Hgh Year Tme-and-date format 24-hour / 12-hour 12-hour format (MM-DD) Tme Hours, Mnutes Date Month, Day Alarm clock functon Off / 1, 2 and 3 (hour, mn) Hypo ndcator Off / Level Press the M button repeatedly, or press and hold t down, untl the requred month s dsplayed. Press the S button to save the chosen settng. You are here The day settng comes next. 56 Settngs Settngs 57

30 The day flashes at top rght of the dsplay. 3.9 Settng the alarm clock functon 3 24-hour format (DD-MM) Beep tone or Acoustc Mode On / Off / Acoustc Mode Brghtness of the dsplay Low / Medum / Hgh Year Tme-and-date format 24-hour / 12-hour 12-hour format (MM-DD) Press the M button repeatedly, or press and hold t down, untl the requred day s dsplayed. Press the S button to save the chosen settng. The alarm clock settngs come next. Tme Hours, Mnutes Date Month, Day Alarm clock functon Off / 1, 2 and 3 (hour, mn) Hypo ndcator Off / Level You are here You can use the meter s alarm clock functon to remnd you to test your blood glucose. You can set three alarms. The meter beeps for 20 seconds at the apponted tme every day. The meter then turns off agan. You can turn the beep tone off earler. Do ths by pressng any of the three buttons. The meter then turns off. A test strp s not advanced. Whle t s beepng, the meter dsplays the followng: 58 Settngs Settngs 59

31 Two steps are nvolved n enterng the settng. Frst you defne whether the alarm clock functon s bascally to be turned on ( ) or off ( ). When t s on, you can enter or change the alarm tmes. The alarm clock functon ( symbol) s factory-set to off. flashes n the dsplay. If you have turned the alarm clock functon on, the settng for the frst alarm tme comes next. The followng s dsplayed: 3 24-hour format 12-hour format If you have turned the alarm clock functon off, the settng for the hypo ndcator comes next. The followng s dsplayed (see Chapter 3.10): Press the M button to turn the alarm clock functon on. s dsplayed. If you press the M button agan, reappears and the alarm clock functon s turned off. Press the S button to save the chosen settng. 60 Settngs Settngs 61

32 Settng alarm tmes The procedure for settng the alarm tme s the same for each alarm. Alarm 1 s used below for llustratve purposes. The number and subsequently and n the dsplay stand for Alarms 1, 2 and 3. The factory settng s 0:00 (24-hour format) or 12:00 am (12-hour format). Ths tme means that alarm 1 s turned off. Only when you set a dfferent alarm tme s Alarm 1 turned on. Frst the hour s set, and then the mnutes. The hour flashes at top left of the dsplay. Press the M button repeatedly, or press and hold t down, untl the requred hour s dsplayed. Press the S button to save the chosen settng. The mnute settng comes next. The mnutes flash at top left of the dsplay. 24-hour format 3 24-hour format 12-hour format 12-hour format Press the M button repeatedly, or press and hold t down, untl the requred mnutes are dsplayed. Press the S button to save the chosen settng. 62 Settngs Settngs 63

33 The settng for Alarm 2 comes next, and then for Alarm 3. Notes 3 Alarm 2 24-hour format 12-hour format You do not have to set all three alarm tmes; you can set just one or two tmes. When you have set your alarm tmes and the hour for the next alarm flashes: press the S button repeatedly untl you reach the hypo ndcator settng (see Chapter 3.10), or If you do not wsh to set a hypo ndcator, press the Test button to turn the meter off. Alarm 3 24-hour format 12-hour format To set the alarm tmes for Alarm 2 and Alarm 3, proceed as descrbed for Alarm 1. The hypo ndcator settng comes next. You can turn off ndvdual alarms by settng ther tme to 0:00 (24-hour format) or 12:00 am (12-hour format). Any other tme means that the alarm clock functon s turned on for ths tme. To set the alarm clock functon for mdnght you must therefore set the tme to one mnute to mdnght (23:59 or 11:59 pm) or to one mnute after mdnght (0:01 or 12:01 am). 64 Settngs Settngs 65

34 The meter can only remnd you to perform a blood glucose test when the year, tme and date have been set n the meter. If you lose the year, tme and date settngs whle replacng the batteres (see Chapter 9), you must re-enter these n order for the alarms to be actve. The settngs for the alarms themselves wll not have been lost Settng the hypo ndcator Beep tone or Acoustc Mode On / Off / Acoustc Mode Brghtness of the dsplay Low / Medum / Hgh Year Tme-and-date format 24-hour / 12-hour 3 If you have turned the alarm clock functon on, the meter wll always beep to remnd you to test your blood glucose even f the beep tone tself s turned off. The beep tone settng has no nfluence on the alarm clock functon. Tme Hours, Mnutes Date Month, Day Alarm clock functon Off / 1, 2 and 3 (hour, mn) Hypo ndcator Off / Level If you turn the alarm clock functon off entrely ( ), the alarm tmes you have set reman saved nevertheless. If the meter s already on when an alarm s due, whether for a blood glucose test or some other reason, the alarm s suppressed. The alarm sounds as soon as you turn the meter off or t turns off automatcally. The alarm does not sound untl then. You are here To help you to recognze a possble hypo, you can set the meter to let you know when your test result ndcates a low blood glucose. You can select what blood glucose level you want ths ndcator to have. As soon as a test result s below the level you have set, you see the flashng symbol dsplayed along wth the result. If the beep tone ( ) s turned on, you hear 5 short double beeps (after to the beep you hear when the result s dsplayed). The 5 short double beeps are not heard when the beep tone s set to off or Acoustc Mode ( ) s set to on. 66 Settngs Settngs 67

35 You can choose between the followng hypo ndcator levels: 3.3 mmol/l 3.9 mmol/l 4.4 mmol/l The hypo ndcator ( symbol) s factory set to off. flashes n the dsplay. Press the M button to move to the next opton. When your chosen level s dsplayed, press the Test button to turn the meter off. The hypo ndcator s then set to ths level. Notes The hypo ndcator s only relable f your hypo ndcator level has been properly selected. Therefore we strongly recommend that you talk to your healthcare professonal about what blood glucose level s your hypo level before you set the ndcator. Ths functon s no substtute for hypoglycema tranng by your doctor or dabetes team. 3 The hypo ndcator level may vary from person to person. Therefore we recommend leavng the hypo ndcator functon turned off when usng the meter n a professonal settng. 68 Settngs Settngs 69

36 4 Testng blood glucose 4.1 Preparng to test blood glucose You wll need the followng tems to carry out the test: the meter wth a test strp drum nserted the lancng devce to obtan blood a lancet for the lancng devce Wash your hands wth warm water and soap, and dry well. Ths stmulates blood flow and ensures that the puncture ste s clean. 4.2 Preparng the lancng devce You use the lancng devce to obtan blood from a fngertp or earlobe, or from other (alternate) stes. If you wsh to obtan blood from alternate stes (such as the base of the thumb, forearm, upper arm, calf or thgh), you must replace the normal black cap on the lancng devce wth a specal, transparent AST cap (whch s ncluded n the pack or s avalable through the Accu-Chek Customer Care Lne). Please read the nstructons for use that come wth the AST cap before you use blood from alternate stes to test blood glucose. You can choose one of 11 dfferent penetraton depth settngs to sut your own skn type. You can use the lancng devce ether docked wth the meter, or undocked. The lancng devce has a plunger at the top (see llustraton n Chapter 1.2). Ths plunger has three functons: prmng the lancng devce trggerng the lancet to obtan blood ejectng the used lancet You can perform all of these functons usng just one hand, as to actvate a functon you only have to press the plunger down. To obtan blood you frst need to nsert a lancet and then set the penetraton depth Testng blood glucose Testng blood glucose 71

37 Notes The Accu-Chek Softclx Plus lancng devce s ntended only for patent self-montorng by a sngle person. The lancng devce must not be used on more than one patent due to the rsk of nfecton. Healthcare professonals testng blood glucose n a mult-patent settng must not use the Accu-Chek Softclx Plus lancng devce to collect blood and should therefore remove the lancng devce from the meter. The lancng devce may be replaced wth a blankng plate (see Chapter 10.1). Only use Accu-Chek Softclx lancets n your Accu-Chek Softclx Plus lancng devce. Usng any other lancets may damage the lancng devce or mpar ts functon. Ths may result n njury Undockng the lancng devce from the meter If you wsh to use the lancng devce undocked from the meter, detach t as follows: 4 Push the slde button n the drecton ndcated by the arrow (1) and hold t there. Wthdraw the lancng devce n the drecton ndcated by the arrow (2). 72 Testng blood glucose Testng blood glucose 73

38 4.2.2 Dockng the lancng devce onto the meter Insertng the lancet 4 Hold the meter so t s horzontal, wth the recess for dockng the lancng devce pontng upwards. Place the flat face of the lancng devce on the lower end of the recess, wth the plunger facng towards the slde button. Slde the lancng devce forward along the meter n the drecton ndcated by the arrow, untl t locks wth an audble CLICK. The gudes along the nsde of the recess must engage wth the grooves along the lancng devce. Remove the cap from the lancng devce. Slde a new lancet nto the lancet holder, and push t n untl you hear t CLICK nto place. 74 Testng blood glucose Testng blood glucose 75

39 Remove the protectve cap from the lancet wth a twstng moton. Notes Droppng the lancng devce wth a lancet nserted may loosen the lancet n ts holder. In that case the lancet s no longer properly lodged and cannot be used to obtan blood. In rare cases the lancet may even protrude from the cap. In a case such as ths you mght njure yourself on the lancet. Therefore take great care not to touch the front of the cap. Should you drop the lancng devce, please pck t up wth care. Remove the cap from the lancng devce. Take care to avod the lancet so as not to njure yourself. Always eject and dspose of the lancet f the lancng devce has been dropped (see Chapter 4.5). Afterwards, re-attach the cap wthout nsertng a lancet. Press the plunger all the way down twce. Only then nsert a lancet agan. 4 For blood collecton, the cap must be on the lancng devce. Wthout ths cap, the lancng devce cannot be prmed, nor can the lancet be trggered. Instead, the lancet s ejected when you press the plunger. Press the cap back on the lancng devce. The locatng notch n the cap (1) must be drectly algned wth the locatng lne on the lancng devce (2). The cap snaps nto place wth an audble CLICK. 76 Testng blood glucose Testng blood glucose 77

40 4.3 Performng a blood glucose test Turnng the meter on Notes Whle the dsplay test s runnng, you may press the Test button to turn the meter off agan. If you do, a test strp s not advanced. 4 If addtonal lnes appear durng the dsplay test or parts of symbols are mssng, please call Accu-Chek Customer Care at If the numerc feld (mmol/l meter) or (mg/dl meter) s affected, the meter may not show your test results correctly. Press the Test button to turn the meter on. Followng the dsplay check (see Chapter 2.2.2) a test strp s automatcally advanced and the test strp symbol and drop symbol flash n the dsplay. You now have about 5 mnutes n whch to draw up blood wth the test strp. 78 Testng blood glucose Testng blood glucose 79

41 4.3.2 Obtanng blood All the fngertps and both the earlobes are sutable for obtanng blood. We recommend obtanng capllary blood from the sde of the fngertp, as ths causes the least amount of pan. 4 You can choose the penetraton depth from a possble 11 settngs rangng from 0.5 to 5.5. Your chosen penetraton depth s vsble n the wndow, e.g.: Rotate the Comfort Dal (cap) untl you reach your chosen settng. The cap snaps nto place at each penetraton depth settng. We recommend a low settng (e.g. 2) f you are usng the lancng devce for the frst tme. To obtan blood you frst need to prme the lancng devce. The larger the number, the greater the penetraton depth. The half-settngs e.g. 2.5 are dentfed by a dot. The settng 2.5 s set when the dot s between 2 and 3 n the wndow. For techncal reasons the settng 5.5 s not dentfed by a dot. Settng 5.5 s set when you rotate the cap beyond settng 5 and the cap snaps nto place. Press the plunger all the way down. The plunger returns about a thrd of the way. The lancng devce s now prmed. 80 Testng blood glucose Testng blood glucose 81

42 Notes Use a new lancet each tme you obtan blood. Ths not only reduces the rsk of nfecton but also helps ensure vrtually panfree blood samplng. 4 Frmly press the lancng devce aganst the chosen puncture ste. You wll feel the slghtly rased rng aganst your skn. Ths s the pnhole through whch the tp of the lancet emerges. Press the plunger all the way down. Ths trggers the lancet, whch penetrates the skn. Usng gentle pressure, massage the fnger towards the fngertp to encourage a drop of blood to form. Do not prme the lancng devce untl you are ready to collect blood. Keepng the lancng devce n ths prmed state can cause parts to become msshapen through tenson, mparng ts operaton. The amount of blood that emerges at the puncture ste depends on the penetraton settng and the pressure used to hold the lancng devce aganst the skn. If the amount of blood you obtan s too small, try agan, applyng more pressure ths tme. If you stll obtan nsuffcent blood, repeat the procedure wth progressvely deeper settngs. If too much blood emerges, reduce the penetraton depth. 82 Testng blood glucose Testng blood glucose 83

43 4.3.3 Drawng up blood wth the test strp Wat untl the test strp symbol and drop symbol flash n the dsplay and the meter beeps (only when the beep tone s turned on). 4 Hold the meter so the test strp s pontng downwards (see llustraton). Immedately after the drop of blood has formed: Hold the tp of the test strp aganst the drop of blood so the black notch s touchng the drop of blood. The test strp draws up blood. Move the fnger away from the test strp as soon as the hourglass symbol s dsplayed and the meter beeps (only when the beep tone s turned on). 84 Testng blood glucose Testng blood glucose 85

44 The test strp has then drawn up enough blood, and test starts. The hourglass symbol ndcates that the meter s busy performng a test. Testng s complete after approx. 5 seconds. The result s dsplayed and the meter beeps (only when the beep tone s turned on). At the same tme the meter automatcally saves the result to memory. Wpe the puncture ste wth a clean, dry tssue. We recommend coverng the puncture ste to keep drt out. Notes Do not touch the test strp unless you are drawng up blood wth t. Resdues (e.g. of food, drnks, or skn cream) on the skn can fnd ther way onto the strp and may produce ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce adverse health effects. Take care not to bend the test strp ether before or whle you draw up blood. Do not bend or move the test strp whle the test s n progress. Bendng or movng the test strp can produce an ncorrect result or cause error message E-5 (see Chapter 12.2) to be dsplayed. Allowng the test strp to draw up blood too early,.e. before the test strp symbol and drop symbol flash, can produce an ncorrect result or cause error message E-5 (see Chapter 12.2) to be dsplayed. Turn the meter off wth the Test button so as to eject the test strp (see Chapter 4.4), and dspose of the test strp. Repeat the blood glucose test wth a new test strp Testng blood glucose Testng blood glucose 87

45 Always hold the meter so the test strp s pontng downwards when you are drawng up blood wth the test strp. If you hold t so the test strp s pontng upwards or sdeways or you put the meter down on a surface wth the test strp stll n t, blood can enter the meter and contamnate t. If the test does not start despte the fact that you have held the drop of blood aganst the test strp, the test strp drew up too lttle blood. In ths case you can, wthn a certan perod, draw up more blood wth the test strp (see the package nsert that came wth the test strp drums). 4 If the meter beeps not once but several tmes when dsplayng the result, ether the hypo ndcator s turned on and the result s below the lmt (see Chapter 3.10) or Acoustc Mode s turned on (see Chapters 3.3 and 6). As soon as the test strp symbol and drop symbol flash n the dsplay, you have approx. 5 mnutes to draw up blood wth the test strp. If you have not drawn up blood wthn ths tme,.e. testng has not started, the meter turns off automatcally. In ths case, press the Test button so as to eject the test strp (see Chapter 4.4), and dspose of the test strp. Start the blood glucose test agan wth a new test strp. 88 Testng blood glucose Testng blood glucose 89

46 4.4 Ejectng the test strp Hold the meter over a waste bn wth the test strp pontng downwards. Notes Always turn the meter off by pressng the Test button, so as to eject the test strp. Do not pull the test strp out. If you do pull the used test strp out, blood can enter the meter and contamnate t. Do not push an ejected test strp back nto the test strp drum. Ths ncludes any unused test strps that you have ejected by accdent. These test strps can produce ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. 4 If you do not turn the meter off, t turns off automatcally after approxmately 60 seconds. The test strp then remans n the meter. The next tme you turn the meter on, t ejects ths test strp and automatcally turns off agan. You can dspose of used test strps wth your regular household waste. Press the Test button to turn the meter off. The used test strp drops out. Before the meter turns off, t shows you the number of test strps remanng n the drum (see Chapter 2.3.2). 90 Testng blood glucose Testng blood glucose 91

47 4.5 Ejectng the used lancet If the lancet does not drop out: Keep the plunger pressed down. 4 Remove the cap from the lancng devce. Hold the lancng devce uprght above a waste bn. Press n the plunger untl t CLICKS. The lancet drops out. Press the cap back on the lancng devce. Hook the edge of the whte collar of the cap behnd the platform of the lancet. A cut-out area on the nsde of the lancet holder makes t easy to hook the lancet platform (see llustraton). Use the whte collar to pull the lancet out. 92 Testng blood glucose Testng blood glucose 93

48 Notes Make sure the lancet has dropped out. Inadvertently leavng the lancet n the lancng devce may result n personal njury. Carefully dspose of used lancets so that the needles cannot cause njury. You must remove the cap to eject the lancet. If you leave the cap n place, pressng the plunger wll prme the lancng devce. 4.6 Symbols you see before, durng or after testng and what they mean You may see the followng symbols dsplayed before, durng or after a test. For further nformaton please see Chapter The beep tone ( ) or Acoustc Mode ( ) s set to on. You have turned on at least one alarm. Whle the result s dsplayed: You have turned the hypo ndcator on. The result s below the ndcator level you set. If the beep tone ( ) s turned on, you hear 5 short double beeps (after the beep you hear when the result s dsplayed). The batteres are runnng low. The use-by perod for the test strp drum has expred. You nserted a partly used test strp drum. The temperature s outsde the permtted range of +10 C to +40 C. The meter s promptng you to perform a performance check. The test strp has drawn up control soluton and the meter has flagged the result as a performance check Testng blood glucose Testng blood glucose 95

49 Instead of a result: The result s above 33.3 mmol/l Instead of a result: The result s below 0.6 mmol/l 4.7 Flaggng specal results You can flag specal results, e.g. results obtaned from alternate ste testng or after exercse, wth an astersk. You can only do ths whle the result s dsplayed and as long as you have not yet turned the meter off. No other symbol Astersk If you press the S button agan, the astersk dsappears agan. The result s saved together wth the astersk as long as the astersk s dsplayed and you press the Test button to turn the meter off. 4.8 Evaluatng results If the dsplayed test result agrees wth the way you feel, follow your doctor s advce. If the dsplayed test result does not agree wth the way you feel, please perform a performance check wth an Accu-Chek Compact Autocontrol control soluton and a new test strp (see Chapter 7). Then perform another blood glucose test. If the new test result stll does not agree wth the way you feel, please contact your doctor. Do not change your treatment based on just one result. 4 Whle the result s dsplayed: Press the S button. The astersk appears n the dsplay. 96 Testng blood glucose Testng blood glucose 97

50 4.8.1 Measurng range Your meter measures blood glucose wthn a defned range ( mmol/l) Implausble results possble causes of error If your meter repeatedly dsplays mplausble results or error messages, please check the followng ponts: 4 Values below ths range are dsplayed as: The result s less than 0.6 mmol/l. Values above ths range are dsplayed as: The result s greater than 33.3 mmol/l. These results are not used to calculate averages (see Chapter 5.3). Dd you perform the blood glucose test accordng to the User s Manual (see Chapter 4.3)? Dd you wash your hands wth warm water and soap to mprove blood flow and to remove any resdues (e.g. of food, drnks, or skn cream)? Dd you dry your hands well? Dd you massage your fnger only gently n the drecton of the fngertp? Dd you bend the test strp ether before or whle you were drawng up blood wth t? Dd you wat for the test strp symbol and drop symbol to flash n the dsplay before drawng up blood wth the test strp? Dd you draw up blood wth the test strp mmedately after the drop of blood formed? Dd you bend or move the test strp whle the test was n progress? yes yes yes no yes yes no 98 Testng blood glucose Testng blood glucose 99

51 5 Usng the meter as an electronc notebook Dd you perform the test wthn the correct temperature range (+10 C to +40 C)? Has the test strps use-by date expred (see label on the contaner of the test strp drum next to the symbol)? Has the 90-day use by perod for the test strp drum expred (see Chapter and possbly the clock symbol n the meter s dsplay)? Are the test strp gude and measurng wndow clean? Have you observed the proper storage condtons for the meter and test strp drums (see Chapter 11 and the package nsert that came wth the test strp drums)? Have you pad attenton to the sources of error stated n the package nsert that came wth the test strp drums? If you gve the responses as specfed to all these questons and stll receve mplausble results or error messages, please call Accu-Chek Customer Care at If your meter has been dropped, that can also lead to mplausble results or error messages. If t has, agan please call Accu-Chek Customer Care at yes no no yes yes yes 5.1 Memory Your meter has a 500-value memory for savng results together wth the tme and date (only when you have set the tme and date). You do not need to save the results manually. The meter automatcally saves and numbers the results. The most recent result always occupes memory locaton 1, the precedng one locaton 2, etc. up to locaton 500. When all of the locatons are occuped and a new test s performed, the result n locaton 500 s erased, the other results are shfted one place back n tme, and the most recent result s saved n memory locaton 1. In addton to the result, the tme and the date, your meter also saves all other nformaton that s relevant to that test. For example, results flagged as performance checks (see Chapter 7) are dsplayed together wth the bottle symbol. Results obtaned at a temperature outsde the permtted range are dsplayed wth the thermometer symbol. Please refer to Chapter 12.1 for a complete lst of symbols whch may be dsplayed Testng blood glucose Usng the meter as an electronc notebook 101

52 5.2 Retrevng results from memory Retrevng older results from memory: 5 Press the M button once to move towards the next older result saved. Wth the meter turned off, press the M button. The meter turns on wthout advancng a test strp. Followng the dsplay check (see Chapter 2.2.2), the most recently saved result s dsplayed together wth the tme, date and. Wth the M button you can move back untl you reach the oldest result (max. 500 results). If you press and hold down the M button, the results are fast-scrolled, startng slowly and then speedng up. To move back agan towards the most recently saved results: Tme and date at the tme of performng a test Press the S button. To fast-scroll, press and hold down the S button. 102 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 103

53 By pressng the S button you can scroll back to the most recent result. Memory locaton 1 Most recent result saved Memory locaton 2 You can ext memory at any tme: To do ths, press the Test button. The meter turns off. Notes 5 Memory locaton 3 Memory locaton 499 Memory locaton 500 Oldest result Always turn the meter on wth the M button f you ntend to revew results held n memory. If you turn the meter on wth the Test button and there s a drum n the meter, a test strp wll be advanced. If no result has been saved n the meter, just three horzontal bars are dsplayed. If the beep tone ( ) or Acoustc Mode ( ) s turned on, a beep sounds each tme when you reach the oldest result (.e. the memory locaton wth the hghest memory locaton number, see Chapter 5.1), and you press the M button, when you reach the most recently saved result agan and you press the S button. 104 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 105

54 If the tme and date were not set at the tme of testng, then the memory locaton number s dsplayed nstead of the tme and date. Memory locaton number 5.3 Average, hghest value and lowest value for 7, 14 and 30 days The meter can dsplay the average values of results from the last 7, 14 or 30 days. Also, you can request that the lowest and hghest values be dsplayed for these 3 perods. All results fallng wthn the relevant perod are ncluded n the calculaton. The current day s always ncluded n the calculaton. If more than 500 test results were saved durng ths perod, the calculaton wll be based on the last 500 test results. 5 If the memory contans both results that were saved together wth the tme and date and results that were not saved wth ths nformaton, then you wll see results shown together wth ther tme and date as well as results shown only wth ther memory locaton number. If you turn the meter off wth the Test button, t shows you the number of test strps remanng n the drum (see Chapter 2.3.2). Wth the meter turned off, press the M button. The meter turns on wthout advancng a test strp. Followng the dsplay check (see Chapter 2.2.2), the most recently saved result s dsplayed together wth the tme, date and. s short for memory. The meter turns off automatcally f you have not pressed a button for 60 seconds. 106 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 107

55 Press the M and S buttons at the same tme. The average of the results from the last 7 days s dsplayed. For each of these three perods you can ask the meter to dsplay the lowest and the hghest values. Lowest value 5 Average The number of results n used n the calculaton s dsplayed at top left (n ths example: 30). The number of days for whch the average was calculated s dsplayed at top rght (n ths example: 7). When one of the three averages s dsplayed: Hghest value Agan press the M and S buttons together to move to the other averages. The 7-day average s followed by the 14-day and 30-day averages, and then agan by the 7-day average. Press and hold down the M button to vew the lowest value. Press and hold down the S button to vew the hghest value. As long as you hold the M button or S button down, the lowest blood glucose value (and the hghest blood glucose value, respectvely) whch you obtaned wthn the perod n queston s dsplayed along wth ts tme and date. If, for nstance, the 7-day average was shown, then the lowest or hghest value relates to the last 7 days. 108 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 109

56 When you release the button, the dsplay reverts to the average. 7-day perod Memory locaton 1 Most recent result saved + Lowest value Average Hghest value You can ext from the average value dsplay at any tme: To do ths, press the Test button. The meter turns off. Notes Results flagged as performance checks wth the bottle symbol are not ncluded n the calculatons day perod Lowest value Average Hghest value 30-day perod Lowest value Average Hghest value Results shown as beng or are not ncluded n the average calculatons, but are dsplayed as the lowest and hghest values, respectvely. The meter calculates the average value, the lowest value and the hghest value for a perod even when the saved results cover a shorter perod. Example: tests were only performed n the last 5 days. In addton, ether no other results were saved or the results that were saved are more than 30 days old. Consequently the results for the last 5 days are used for calculatng the average, the lowest value and the hghest value for all three perods (7, 14 and 30 days). 7-day perod 110 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 111

57 If a large number of results were saved wthn one perod, calculaton of the average may take a whle. flashes n the dsplay whle the calculaton s n progress. If no results were saved n memory for the perod n queston, three horzontal bars are dsplayed nstead of a numercal value. If, for example, the results are more than 7 days old, the average, lowest value and hghest value cannot be calculated for 7 days. The meter can only perform the necessary calculatons as long as the results were stored together wth the tme and date. If you have not entered the tme and date, three horzontal bars are dsplayed nstead of the numercal values. In the event that you changed the date or tme, then performed a test and afterwards re-set the date/tme, the meter only ncludes results t saved n unnterrupted chronologcal order. If the chronologcal order was nterrupted, the earler results are gnored. If you have not performed any tests snce you made the change, three horzontal bars are dsplayed nstead of a numercal value. If the memory contans both results that were saved together wth the tme and date and results that were saved wthout ths nformaton, the averages and respectve lowest and hghest values wll only be calculated from results saved wth the tme and date that come chronologcally before the frst result wthout the tme and date. Example: The meter saved 150 results over a perod of 50 days. The result n memory locaton 51 was saved wthout the tme and date. The results n memory locatons 1 to 50, whch were saved together wth the tme and date, cover a 20-day perod. For calculaton of the 7- and 14-day averages, those results are ncluded that are wthn the perod n queston. The 30-day average s calculated from all 50 results, even f these only covered a 20-day perod. The results after the result wthout the tme and date (memory locaton 52 and hgher) are no longer avalable for calculaton of averages, even f they were saved wth the tme and date. If you turn the meter off wth the Test button, t shows you the number of test strps remanng n the drum (see Chapter 2.3.2). The meter turns off automatcally f you have not pressed a button for 60 seconds Usng the meter as an electronc notebook Usng the meter as an electronc notebook 113

58 5.4 Downloadng test results to a PC, handheld computer or a specal evaluaton system The nfrared wndow s located at the front end of the meter. The meter has an nbult nfrared wndow permttng wreless data downloadng to a sutably equpped PC, handheld computer (PDA), or specal evaluaton systems. 5 Roche Dagnostcs offers a varety of specal hardware and software that extend the ntegrated notebook functons of your meter. These products enable you and your doctor to manage your data more effectvely and, through ther graph and table vews, make t easer for you to understand your results. Dependng on the type of analyss you ntend to perform, you wll requre a specal software product and/or specal hardware products. For further nformaton please call Accu-Chek Customer Care at Be sure to read the operatng nstructons suppled wth the software and hardware you are usng. These wll nclude nstructons on how to download your data. Make the recevng end (software product or hardware) ready to download the results. 114 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 115

59 Poston the meter 5-20 cm away from the nfrared wndow of the recevng end. Pont the two nfrared wndows towards one another. If necessary, start the results download at the recevng end (software product or hardware). 5 Durng the download both arrows flashed alternately. Durng the download only those results that are new to the recevng end,.e. those have not yet been downloaded, are sent. Wth the meter turned off, press the M and S buttons at the same tme. The meter turns on. Followng the dsplay check (see chapter 2.2.2), the followng appears: Once downloadng has fnshed, the arrows stop flashng and the meter s automatcally turned off by the recevng end. If the meter s not turned off, press the Test button to turn t off. 116 Usng the meter as an electronc notebook Usng the meter as an electronc notebook 117

60 Notes Your results can only be fully analysed f all of the results have been saved together wth the date and tme,.e. as long as you have set the date and tme. The results reman n the meter s memory followng downloadng. You cannot perform a test whle results are beng downloaded. If the results download does not occur (the arrows do not start to flash) or was ncomplete, the meter turns tself off automatcally after approxmately 5 mnutes. Ths s what mght have happened: A download error occurred. Start the results download agan. The nfrared wndows are too far apart or not properly facng one another. Reduce the dstance between the two nfrared wndows to 5-20 cm and poston them so they are pontng towards one another. Start the results download agan. Another devce wth an nfrared source turned on or a strong lght source s too close to the two nfrared wndows. Remove the devce or lght source and start the download agan. An object, for nstance, s blockng communcaton between the two nfrared wndows. Remove the object and start the download agan. An error occurred at the recevng end. Read the relevant manual(s). If you already have a hardware or software product from Roche Dagnostcs to enable you to transfer and evaluate results, t may not recognze more recent meters, so the results wll not be downloaded. You may need a more recent software verson for your hardware or software product. In ths case please call Accu-Chek Customer Care at Data transfer does not follow the IrDA standard (IrDA stands for Infrared Data Assocaton) Usng the meter as an electronc notebook Usng the meter as an electronc notebook 119

61 6 Acoustc Mode Acoustc Mode s ntended for persons who are vsually mpared. When Acoustc Mode s turned on, the meter gudes you through the blood glucose test usng beep tones; t also outputs the result as a seres of beeps. The meter beeps addtonally when the batteres are almost exhausted, the test strp drum s empty, or an error message s dsplayed. Chapter 3.3 descrbes how to turn Acoustc Mode on. Vsually mpared persons need a sghted person to nstruct them n the use of the meter and to assst them wth all aspects of ts operaton. Vsually mpared persons must not test ther blood glucose wthout assstance from a sghted person. An ntmate knowledge of how results are represented as beeps and how to dstngush results from other beeps s crucal to relably recognzng the result. The chapters that now follow explan the beep tones n detal. In addton, tranng software (the BeepLearn-Programm) to help you nterpret results announced n the form of beeps s avalable on CD from Accu-Chek Customer Care. Practce lstenng to beeps from actual tests or from the tranng software together wth a sghted person untl you can clearly recognze and nterpret the results and other beeps you wll hear. There are two types of beep tone, dfferng n ptch. Warnngs have a hgher tone (Tone 2, represented below as ) than the other beep tones (Tone 1, represented below as ). The followng table shows whch tone sounds for whch event. Turnng on Chapter 6.1 Meter ready to test Chapter 6.2 Start of test Chapter 6.2 Announcement of the result Sgnal that results are due to be announced Announcement of an error message Notfcaton that the batteres are almost exhausted Notfcaton that the drum s empty Chapters 6.3 and 6.4 Chapters 6.3 and 6.4 Chapters 6.2 and 6.5 Chapter 6.5 Chapter 6.5 Tone 1 Tone 2 (warnng) 6 If you have problems determnng the results from the beeps, you should not use Acoustc Mode. 120 Acoustc Mode Acoustc Mode 121

62 6.1 Beep tones at power-on When Acoustc Mode s set to on, you hear a long beep ( ) when you turn on the meter. Ths s rrespectve of whch button you use to turn the meter on: the Test button n order to perform a test (see Chapter 4.3.1) the S button n order to change settngs (see Chapter 3) the M button n order to retreve results from memory (see Chapter 5) the M and S button n order to send results (see Chapter 5.4) If you press the Test button or M button to turn the meter on, you frst hear the long power-on beep followed by 6 further beeps spaced as ( ). 6.2 Beep tones durng testng Followng the power-on beep and the sequence of beeps, you wll hear the followng whle you test: a sngle beep when the meter s ready to test so you can let the test strp draw up blood or control soluton, a sngle beep when the test strp has drawn up suffcent blood or control soluton and the test s startng, several beeps each tme the meter dsplays an error message (see Chapter 6.5). 6.3 Announcement of the result followng a test In Acoustc Mode, whenever your meter dsplays a result followng a blood glucose test, t also announces the result as a seres of beeps. The result s not treated as an entty, but s broken down nto ndvdual dgts. Examples: The result 7.6 mmol/l s announced as 0 7 decmal pont 6. The result 138 mg/dl s announced as Acoustc Mode Acoustc Mode 123

63 Each dgt s represented by the correspondng number of beeps; e.g. 4 beeps for the number 4 ( ). Zero s represented by a long beep ( ). The result s announced three tmes n successon. Each result s preceded by two short beeps ( - - ). Altogether, therefore, you hear: - - result - - result - - result. mmol/l meters Frst the tens are announced, then the unts, then the decmal pont and fnally the tenths. There s a short pause between each group of beeps. The tens are always announced, even when the result s below 10. The tens n ths case are represented by 1 long beep, sgnfyng zero. The decmal pont s represented by 1 very short beep (. ). Examples: The result 13.8 mmol/l s announced as follows: 1 beep pause 3 beeps pause 1 very short beep pause 8 beeps (. ) The result 4.0 mmol/l s announced as follows: 1 long beep (for 0 tens) pause 4 beeps pause 1 very short beep pause 1 long beep (. ) mg/dl meters Frst the hundreds are announced, then the tens, and fnally the unts. There s a short pause between each group of beeps. The hundreds are always announced, even when the result s below 100. The hundreds n ths case are represented by 1 long beep, sgnfyng zero. Examples: The result 180 mg/dl s announced as follows: 1 beep pause 8 beeps pause 1 long beep ( ) The result 72 mg/dl s announced as follows: 1 long beep (for 0 hundreds) pause 7 beeps pause 2 beeps ( ) Results that are lower than 0.6 mmol/l or 10 mg/dl and are dsplayed as are announced acoustcally as 0 decmal pont 0 and 0 0 0, respectvely. Results that are hgher than 33.3 mmol/l or 600 mg/dl and are dsplayed a are announced acoustcally as 9 9 decmal pont 9 and 9 9 9, respectvely Acoustc Mode Acoustc Mode 125

64 Note Notes Informaton or warnngs n the form of symbols (e.g. drum symbol or symbol, see Chapter 12.1) that are dsplayed together wth the result are not announced acoustcally. 6.4 Announcement of results and average values from memory Only the last (most recent) result that was saved can be announced acoustcally. If you press the M button to turn the meter on, you frst hear the long power-on beep followed by the beep sequence and then the most recent result. Only the average for the last 7 days s announced acoustcally. The lowest and hghest results wthn ths perod are not announced acoustcally. The announcement follows the same pattern as any result that s announced drectly followng a test. If the 7-day average cannot be calculated, three horzontal bars are dsplayed. Ths s sgnalled acoustcally wth 3 long beeps representng 3 zeroes ( ). If the result that was most recently saved s flagged by the bottle symbol as beng a performance check result (see Chapter 7), t s announced n the same way as any blood glucose test result. There s no acoustc sgnal to dentfy t as a performance check result. Lkewse, there s no acoustc sgnal to dentfy a result flagged by an astersk as beng a specal result (see Chapter 4.7). The 14 and 30-day averages and the lowest and hghest results wthn these two perods (see Chapter 5.3) are not announced acoustcally n Acoustc Mode, but only dsplayed. If no result has been saved, just three horzontal bars dsplayed. There s no acoustc announcement. are Acoustc Mode Acoustc Mode 127

65 7 Checkng your meter 6.5 Announcement of warnngs and error messages When the batteres wll soon be exhausted or the last test strp n a drum has been used, the meter ssues an acoustc warnng. Ths conssts of two short beeps sounded three tmes n successon ( ). The warnng s gven at dfferent tmes. Batteres are almost exhausted (the battery symbol s dsplayed, see Chapter 9): Ths acoustc warnng s sounded when you turn the meter on. You have used the last test strp n the drum ( and drum symbol flash, see Chapters 2.3 and 12.2): The acoustc warnng s gven after you have pressed the Test button to turn the meter off. If error messages ( wth a number or the, see Chapter 12.2) are dsplayed, these are announced by two short beeps sounded four tmes n successon ( ). Ths sequence s sounded only once and s not repeated. The same sequence of beeps s sounded for all error messages,.e. they are not dfferentated acoustcally. To ensure your results are always dependable, you should perodcally check the performance of your meter. Do ths by performng a performance check usng the Accu-Chek Compact Autocontrol control solutons, each tme after you have opened a new pack of test strp drums, after you have replaced the batteres. after your meter has dsplayed the bottle symbol promptng you to perform a performance check, after you have cleaned the measurng wndow of the meter, f your result does not agree wth how you feel. Please call Accu-Chek Customer Care at to obtan the control solutons Acoustc Mode Checkng your meter 129

66 7.1 What you need To perform a performance check you need the followng tems: meter wth a test strp drum nserted Accu-Chek Compact Autocontrol G1 control soluton (low glucose concentraton) or Autocontrol G2 control soluton (hgh glucose concentraton) Concentraton table for the control solutons (see label on the contaner the test strp drum came n). 7.2 Performng a performance check Read the package nsert that came wth the control solutons. 7 Press the Test button to turn the meter on. Note The concentraton table for the control solutons can be found on the peel-off label attached to the drum contaner. When conductng the performance check, always make sure that the peel-off label wth the concentraton table belongs to the test strp drum that s currently n the meter. Followng the dsplay check (see Chapter 2.2.2) a test strp s automatcally advanced, and the test strp symbol and the drop symbol flash n the dsplay. 130 Checkng your meter Checkng your meter 131

67 You now have about 5 mnutes n whch to draw up control soluton wth the test strp. Take a bottle of control soluton. Open t and wpe the tp of the dropper wth a clean, dry paper towel n order to remove any dred-on resdues. Invert the val and hold t downwards at an angle. Squeeze t gently untl a small drop s suspended from the tp. 7 Hold the meter so the test strp s pontng downwards (see llustraton). Apply the drop to the surface of a clean, easly washable object made of glass, porcelan or stanless steel (e.g. a plate or spoon). Hold the tp of the test strp to the drop of control soluton. 132 Checkng your meter Checkng your meter 133

68 The test strp draws up the control soluton through the black notch. Move the test strp away from the control soluton as soon as the hourglass symbol s dsplayed and the meter beeps (provded the beep tone s turned on). The test strp has then drawn up enough control soluton, and testng starts. The hourglass symbol ndcates that the meter s busy performng a test. The meter automatcally detects that the test strp has drawn up control soluton. The bottle symbol appears addtonally n the dsplay when the test starts. Immedately after the result s dsplayed: Compare the result wth the concentraton table prnted on the peeloff label attached to the drum contaner. The result must be wthn the concentraton range stated. The concentraton table has two rows and two columns. Rows 1 and 2 contan concentraton data for the two dfferent control solutons, G1 and G2; the columns are for the two dfferent unts of measurement, mmol/l and mg/dl. Make sure you compare the result wth the concentraton data stated for the control soluton you used and the unt of measurement your meter dsplays. 7 Testng s complete after approx. 5 seconds. The result s dsplayed and the meter beeps (provded the beep tone s turned on). The meter at the same tme saves the result together wth the bottle symbol. The saved result s thus recognzable as beng a performance check result. Accu-Chek Compact Autocontrol mmol/l mg/dl G G The fgures shown are for llustraton only Control soluton used Unt of measurement 134 Checkng your meter Checkng your meter 135

69 Subsequently hold the meter drectly above a waste bn wth the test strp pontng downwards. Press the Test button to turn the meter off. The used test strp drops out. Before the meter turns off, t shows you the number of test strps remanng n the drum (see Chapter 2.3.2). Wpe the tp of the dropper wth a clean, dry paper towel and close the bottle tghtly. You can dspose of empty or only partly used bottles of control soluton together wth your regular household waste. Please refer also to the notes n Chapters 4.3 and Possble causes of error durng the performance of performance checks If the result s outsde the stated concentraton range, perform a second performance check. If the result of ths second check s outsde the concentraton range as well, please check the followng ponts: 7 Notes The control soluton you apply to a washable object must come from a suspended drop. Do not use the drop f t has run down the outsde of the tp of the dropper. Ths may lead to results that are too hgh. Control soluton that s to be drawn up by the test strp must just have been freshly appled to the object. The control soluton must not be left exposed on the surface for any length of tme, or t may gve results that are too hgh. Results flagged as performance checks wth the bottle symbol are not ncluded n the calculaton of averages and lowest and hghest results. Dd you perform the performance check as descrbed above? Dd you wpe the tp of the dropper before you appled control soluton to the surface of the washable object? Dd you use a suspended drop of control soluton? Was there prolonged contact between the control soluton and the washable object? Dd you bend the test strp ether before or whle you were drawng up control soluton? Dd you wat for the test strp symbol and drop symbol to flash n the dsplay before drawng up control soluton wth the test strp? yes yes yes no no yes 136 Checkng your meter Checkng your meter 137

70 no yes yes yes If your answers match those ndcated on the prevous pages, and your results are stll outsde the stated concentraton range, please contact Accu-Chek Customer Care at Note: If your meter has been dropped ths can also lead to mplausble results or error messages. If ths s the case, agan please contact Accu-Chek Customer Care. Note 7 Dd you bend or move the test strp whle the test was n progress? Dd you compare the result wth the concentraton data specfcally relatng to the control soluton you used? Does the concentraton table belong to the test strps that are currently n the meter? Dd you perform the test wthn the correct temperature range (+10 C to +40 C)? Has the use-by date for the control soluton or the test strps expred (see label on the bottle and the test strp drum next to the symbol)? Has the 90-day use-by perod for the test strp drum expred (see Chapter and possbly the clock symbol n the meter s dsplay)? no no If a performance check produces results that are outsde the stated concentraton range, t s no longer certan that the meter and test strps are functonng properly. Blood glucose tests may then delver ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. Are the test strp gude and measurng wndow clean? Have you observed the proper storage condtons for the meter, test strps and control solutons (see Chapter 11 and the package nserts that came wth the test strps and control solutons)? yes yes Has the control soluton been open for less than three months? Once opened, control solutons are only stable for three months and must not be used after ths perod. yes 138 Checkng your meter Checkng your meter 139

71 8 Cleanng the meter and lancng devce 8.1 Cleanng the meter Your meter uses an optcal measurng method that reles heavly on all of ts components beng clean. Owng to the way the test strp works, the meter does not normally come nto drect contact wth blood or control soluton. Regular cleanng s therefore largely unnecessary. In the event of the meter becomng soled through mproper use, cleanng t may become necessary. Wpe away any solng from the housng or dsplay wth a cloth lghtly mostened wth cold water or 70 % ethanol. Clean the test strp gude and measurng wndow thoroughly f the test strp gude has become vsbly soled, error message E-5 s dsplayed (see Chapter 12.2) and the soled measurng wndow s the cause. Do ths as follows: If the meter s on, press the Test button to turn t off. Wat for the motor to stop. Wpe the test strp gude wth a cotton swab lghtly mostened wth cold water or 70 % ethanol. 8 Hold the meter n your rght hand and place the thumb of your left hand nto the recess below the drum compartment cover. Then pull the drum compartment cover wth your fngers slghtly to the front and lft t up. 140 Cleanng the meter and lancng devce Cleanng the meter and lancng devce 141

72 Notes Use only cold water or 70 % ethanol to clean the meter. Any other cleanng agents may damage the meter or mpar ts measurng functon. Use a lghtly mostened cloth or a lghtly mostened cotton swab. Do not spray anythng onto the meter and do not mmerse t n the cleanng lqud. Dong so may damage the meter s nternal components and stop t from workng properly. Make sure that no lqud enters the meter. Avod scratchng the measurng wndow, as dong so could mpar ts measurng functon. 8 Wpe the measurng wndow and the area surroundng t wth a cotton swab lghtly mostened wth cold water or 70 % ethanol. Remove any fluff or lnt that may reman. Allow areas you have wped tme to dry thoroughly. Fold the drum compartment cover down and press t shut. There wll be an audble CLICK. Perform a performance check (see Chapter 7). Make sure that the drum compartment cover s tghtly closed. If t s not properly closed, the meter wll not turn on when you press the Test button. Healthcare professonals usng the meter to test several patents blood glucose must also read the drectons n Chapter 10.3 relatng to dsnfecton. 142 Cleanng the meter and lancng devce Cleanng the meter and lancng devce 143

73 9 Changng the batteres 8.2 Cleanng the lancng devce Clean your lancng devce regularly to keep t n good workng condton. If any blood gets on t, always wpe ths away mmedately. Clean the outsde of the lancng devce only. Wpe t once a week wth a cloth lghtly mostened wth 70 % ethanol or 70 % sopropanol (avalable from your pharmacst). In addton, thoroughly wpe the nsde of the cap usng a cotton bud lghtly mostened wth one of the two cleanng fluds. Notes After cleanng, allow the lancng devce tme to dry thoroughly. Never dp the lancng devce n cleanng lqud. Dong so may damage the nternal parts of the lancng devce so affectng ts operaton. Use only 70 % ethanol or 70 % sopropanol to clean the lancng devce. Other cleanng agents may attack the plastc and stop the lancng devce from operatng properly. When the battery symbol frst appears n the dsplay, the batteres are runnng low. Wth these batteres you can perform about 50 more tests. However, we recommend that you replace the batteres as soon as possble. By then the batteres wll have been heavly draned, and changeable condtons (e.g. cold surroundngs) can affect ther performance even further. If the meter s on, press the Test button to turn t off. Press lghtly on the battery compartment cover and slde t n the drecton of the arrow. Lft off the cover. Remove the used batteres Cleanng the meter and lancng devce Changng the batteres 145

74 Notes A fresh par of batteres has enough power ether for about 1000 tests or for one year s worth of tests. If you have changed the brghtness of the dsplay to level 3 (hgh) or set Acoustc Mode to on, the battery lfe wll be shorter. When you replace the batteres, your results always reman saved. Insert two new batteres (type AAA, LR 03, AM 4 or mcro). The year, tme and date settngs only reman saved as long as you do not take longer than two mnutes to change the batteres, you do not press any button whle the batteres are not nserted, you do not open the drum compartment whle there are no batteres nserted. you turn the meter off before removng the batteres. 9 The mnus (-) ends of the batteres must match up wth the mnus marks n the battery compartment. Re-attach the battery compartment cover. The three hooks on the undersde of the cover must engage wth the slots along the edge of the battery compartment. The cover s then just loosely held n poston. Slde the battery compartment cover back nto place. It locks wth an audble CLICK. If one of the above condtons s not met you wll need to re-enter the year, tme and date. If you do not enter the year, tme and date, all future results wll be dsplayed and saved wthout the tme and date. In that case 146 Changng the batteres Changng the batteres 147

75 the test results saved n memory wll be numbered consecutvely so you can stll recognze the order n whch they were saved (see Chapter 5.2). If the year, tme and date have been lost, the meter rotates the drum n order to re-read the bar code. Never throw batteres nto a fre. Ths s dangerous because they may explode. Remove the batteres f you wll not be usng your meter for any length of tme. When you nsert the batteres agan, remember to set the year, tme and date. You can also use rechargeable NMH batteres. If you do, please note the followng: Thnk of the envronment. Dspose of used batteres sensbly. The number of tests you can perform wth recharged batteres s consderably less than wth ordnary batteres. To be ready to test at any tme, you need to keep two rechargeable batteres n reserve whch you can charge whle the frst par are n the meter. Recharged batteres lose ther charge durng storage. When the battery symbol frst appears, you can perform sgnfcantly fewer than 50 further tests. Wth old and exhausted rechargeable batteres you may not be able to perform even one more test. The performance and useful lfe of rechargeable batteres depends to a large extent on the qualty of the battery charger you are usng. Owng to the hgher power consumpton, we advse aganst usng rechargeable batteres f the brghtness of the dsplay s set to level 3 (hgh) or f Acoustc Mode s set to on. 148 Changng the batteres Changng the batteres 149 9

76 10 Blood glucose testng n a mult-patent settng Informaton for healthcare professonals Only professonals workng n doctors practces, hosptals and dabetes tranng centres as well as n-patent and ambulent nursng staff are allowed to perform blood glucose tests on more than one patent usng the same Accu-Chek Compact Plus meter. When usng the meter always follow the recognzed procedures for handlng objects that are potentally contamnated wth human materal. Practce the hygene and safety polcy of your laboratory or nsttuton. Also, to stop your meter becomng contamnated, please follow the drectons prnted on the next few pages. Any patent wth an nfecton or sufferng from an nfectous dsease and any patent who s a carrer of a multresstant organsm must be assgned hs/her own meter. Ths apples also f a patent s suspected of beng one of the above. For as long as the suspcon exsts, the meter must not be used to test any other patent. The lancng devce s ntended only for patent self-montorng by a sngle person. It must not be used to collect blood n a multpatent settng as t does not ncorporate any features to guard aganst cross-nfectons. Healthcare professonals testng blood glucose n a mult-patent settng must not use the Accu-Chek Softclx Plus lancng devce to collect blood and should therefore remove the lancng devce from the meter. The lancng devce may be replaced wth a blankng plate (see Chapter 10.1). Notes Patents and healthcare workers are potentally at rsk of becomng nfected when the same Accu-Chek Compact Plus meter s used to test blood glucose n several patents. Any object comng nto contact wth human blood s a potental source of nfecton (see: Clncal and Laboratory Standards Insttute: Protecton of Laboratory Workers from Occupatonally Acqured Infectons; Approved Gudelne Thrd Edton; CLSI document M29-A3, 2005). The hypo ndcator level may vary from person to person. Therefore we recommend leavng the hypo ndcator functon turned off when usng the meter n a professonal settng Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 151

77 10.1 Replacng the lancng devce wth a blankng plate Undock the lancng devce from the meter as follows. Instead of the lancng devce you can use a blankng plate whch s avalable from Accu-Chek Customer Care at Push the slde button n the drecton ndcated by the arrow (1) and hold t there. Slde the lancng devce out n the drecton ndcated by the arrow (2). Hold the meter so t s horzontal, wth the recess for dockng the lancng devce pontng upwards. Slde the blankng plate over the recess from the left along the meter n the drecton ndcated by the arrow. The gudes along the nsde of the recess must engage wth the grooves along the blankng plate. The blankng plate s properly attached when t locks nto place wth an audble CLICK. 152 Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 153

78 10.2 Performng a blood glucose test Wear protectve gloves. Wash or dsnfect the patent s fnger and allow t to dry thoroughly. The drop of blood does not spread so easly over dry skn. Use only a lancng devce that s approved for use by healthcare professonals. Use a lancng devce wth adjustable penetraton depth settngs. Select a penetraton depth to sut the patent s skn type. Start wth a shallow depth settng. Select a puncture ste along the sde of a fngertp. Turn the fnger so the chosen puncture ste s facng upwards, and keep t facng upwards. The drop of blood cannot then spread so easly. Lance the sde of the fngertp. Usng gentle pressure, massage the fnger towards the fngertp to encourage a drop of blood to form. A proper but nevertheless small drop of blood (approx. 1.5 μl) must form. Correct Drop of blood approx. 1.5 μl Hold the meter wth the test strp pontng downwards (see llustraton). Immedately after the drop of blood has formed: Hold the tp of the test strp aganst the drop of blood so the black notch s touchng the drop of blood. The test strp draws up blood. Move the test strp away from the drop of blood as soon as the hourglass symbol s dsplayed and the meter beeps (only when the beep tone s turned on). The test strp has then drawn up enough blood, and test starts. When the result s dsplayed, hold the meter uprght over a waste bn and press the Test button to turn t off. The used test strp drops out Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 155

79 Notes Always hold the meter so the test strp s pontng downwards when you are drawng up blood wth the test strp. If you hold t so the test strp s pontng upwards or sdeways or you lay the meter down wth the test strp stll n, blood can enter the meter and contamnate t. Hold the meter wth the test strp pontng downwards untl the result s dsplayed (measurng tme approx. 5 seconds) and you have ejected the test strp. Wrong Test strp pontng upwards To test blood glucose you requre approxmately 1.5 μl of blood. Avod producng large drops of blood on the patent s fnger. Where the drops of blood are too large, the meter may come nto contact wth the blood. Wpe off any large drops of blood. Test usng the drop of blood that forms agan at the puncture ste. Resdues of water or dsnfectant on the skn can dlute the drop of blood and so produce false results. Always turn the meter off by pressng the Test button, so as to eject the test strp. Do not pull the test strp out. If you do pull the used test strp out, blood can enter the meter and contamnate t. Dspose of used lancets or dsposable lancng devces and used test strps accordng to local hygene and safety regulatons. The test strp cannot properly draw up blood that has spread over the skn. Wrong Drop of blood that has spread If you collect blood from an earlobe, be sure that the blood s on top and not hangng from the earlobe. Hold the earlobe or poston the patent so the puncture ste s on top. 10 Wrong Drop of blood too large 156 Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 157

80 10.3 Dsnfectng the meter The Accu-Chek Compact Plus meter may be dsnfected. Dsnfecton s performed accordng to the degree of solng (see When to dsnfect ). What to dsnfect The followng parts of the meter may become contamnated: the area around the test strp gude Hold the meter n your rght hand and place the thumb of your left hand nto the recess below the drum compartment cover. Then pull the drum compartment cover wth your fngers slghtly to the front and lft t up. Once you have opened the drum compartment cover, you wll see beneath t the small measurng wndow and have access to the lower edge of the drum compartment cover. 10 the lower edge of the drum compartment cover the measurng wndow the housng In order to dsnfect the lower edge of the drum compartment cover and measurng wndow, you need to open the drum compartment cover. Frst make sure the meter s turned off. 158 Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 159

81 Cotton buds, wpes and cloths lghtly mostened wth dsnfectant are all sutable for dsnfectng the meter. Allow areas you have wped tme to dry thoroughly. Remove any fluff or lnt that may reman. Fold the drum compartment cover down and press untl t closes. It locks wth an audble CLICK. Ensure that the drum compartment cover s properly closed. Notes The test strp gude and measurng wndow must always be kept clean. When you turn the meter on to perform a test, the test strp s advanced over the measurng wndow and out through the test strp gude. Any resdues of blood remanng on the measurng wndow or n the test strp gude may get onto the test strp and contamnate t. Make sure that no lqud enters the meter. Avod scratchng the measurng wndow, as scratches could mpar ts measurng functon. Do not spray anythng onto the meter and do not mmerse t n lqud. Dong so may damage the meter s nternal components and stop t from workng properly. When to dsnfect Each tme after you have tested a patent s blood glucose: wpe the area around the test strp gude. If you fnd blood on the cloth, wpe also the test strp gude tself and the measurng wndow. If there s blood on the meter: wpe the meter. If blood has entered the meter: wpe the area around the test strp gude, the lower edge of the drum compartment cover and the measurng wndow. Allow areas you have wped tme to dry thoroughly. The meter, test strp gude and measurng wndow must be thoroughly cleaned and dsnfected at least once a day after use. Carefully check all recesses, grooves and gaps, as well as the blankng plate Blood glucose testng n a mult-patent settng Blood glucose testng n a mult-patent settng 161

82 11 Measurement and storage condtons 10.4 Sutable dsnfectants Use only dsnfectants of proven effectveness quoted n offcal gudelnes (e.g. Clncal and Laboratory Standards Insttute: Protecton of Laboratory Workers from Occupatonally Acqured Infectons; Approved Gudelne Thrd Edton; CLSI document M29-A3, 2005). Use alcohol-based surface dsnfectants wth vrucdal actvty. Sutable agents are those, for nstance, based on alcohols, aldehyde cleavers and quaternary compounds*. Use them accordng to manufacturer s nstructons. The relablty of your meter and lancng devce as well as the accuracy of your results s nfluenced by a number of factors. Pay close attenton to the followng ponts. A meter that has been dropped can produce false results Temperature range Wthout the batteres and wthout the test strp drum the meter may be stored at between -25 C and +70 C. Wth the batteres and wthout the test strp drum the meter may be stored at between -10 C and +50 C. At temperatures above +50 C the batteres could leak and damage the meter. 11 * Lst of dsnfecton methods that have been tested n accordance wth the Rchtlnen für de Prüfung chemscher Desnfektonsmttel [Gudelnes for testng chemcal dsnfectants] and the Anforderungskatalog [Requrements catalogue] of the DGHM (Deutsche Gesellschaft für Hygene und Mkrobologe e V.) [=German Socety for Hygene and Mcrobology] based on the DGHM standard methods for testng chemcal dsnfecton methods and have been found to be effcacous by the Desnfektonsmttel-Kommsson [=Dsnfectants Commsson] of the DGHM n collaboraton wth representatves of the followng professonal assocatons: DGKH (Deutsche Gesellschaft für Krankenhaushygene e. V.) [=German Socety for Hosptal Hygene], GHU (Gesellschaft für Hygene und Umweltmedzn e. V.) [=German Socety for Hygene and Envronmental Medcne], DVV (Deutsche Verengung zur Bekämpfung der Vruskrankheten e.v.) [=German Assocaton for the Control of Vral Dseases] and DVG (Deutsche Veternärmedznsche Gesellschaft e. V.) [=German Veternary Socety] At temperatures below -10 C the batteres do not have enough power to keep the nternal clock functonng. Wth the batteres and wth the test strp drum the meter may be stored at between +2 C and +30 C. For blood glucose tests and performance checks the permtted range s from +10 C to +40 C. 162 Blood glucose testng n a mult-patent settng Measurement and storage condtons 163

83 Blood glucose tests may be performed at the lmt of the permtted range (between +6 C and +10 C or between +40 C and +44 C). When the temperature s at the lmt of the permtted range, the thermometer symbol flashes n the dsplay. Do not use results obtaned at the lmts of the permtted temperature range as a bass for makng therapeutc decsons. The results may be ncorrect. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. Tests cannot be performed at temperatures below +6 C and above +44 C. In ths event the followng message s dsplayed: Keep the lancng devce at temperatures between -25 C and +70 C. Never try to speed up warmng or coolng of your meter, e.g. by placng t on a radator or n a refrgerator. Dong so can damage the meter and cause t to gve ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects. Keep the lancng devce wthout a lancet nserted. Never expose the lancng devce to hgh temperatures (e.g. n a hot car). Hgh temperatures can cause parts of the lancng devce to become warped, so mparng ts operaton Lght condtons All dsplayed numbers and symbols appear yellow. Brght lght shnng on the dsplay may make them dffcult to read. Sheld the meter f necessary usng your body, for nstance. Keep the meter away from very strong lght sources (e.g. drect sunlght, studo lghtng, spot lghts, etc.). These may nterfere wth the proper functonng of the meter and cause error messages to be dsplayed Measurement and storage condtons Measurement and storage condtons 165

84 12 Symbols, error messages and troubleshootng 11.3 Humdty Only test blood glucose at a relatve humdty of between 20 % and 85 %. Keep the meter and lancng devce at a relatve humdty of between 20 % and 85 %. Sudden changes n temperature cause condensaton to form n or on the meter. If ths happens, do not turn the meter on. Make sure that t returns to ambent temperature slowly. Never keep t n a room that s lkely to harbour condensaton (e.g. a bathroom) Local sources of nterference Strong electromagnetc felds may nterfere wth the proper operaton of the meter. Do not use the meter n close to sources of strong electromagnetc radaton. To avod electrostatc dscharge, do not use the meter n a very dry envronment, especally one n whch synthetc materals are present. In addton to test results, the tme and the date, your meter also dsplays other symbols and error messages. Some of these routne dsplay messages have already been explaned n earler chapters. Followng s a complete summary of all symbols and messages, what they mean and what actons you should take when they appear. When you use your meter, please watch out for any symbols and error messages that are dsplayed. They provde you wth mportant nformaton. If you do not recognze a symbol or do not understand an error message, please refer mmedately to ths chapter for an explanaton. Otherwse you run the rsk of wrongly nterpretng your results. On some of the pages that follow you wll see a double arrow. It sgnfes the followng: when t appears on the rght at the bottom of the page the descrpton contnues on the next page when t appears on the left at the top of the page ths s the contnuaton of the descrpton from the last page Measurement and storage condtons Symbols, error messages and troubleshootng 167

85 12.1 Symbols shown n the dsplay Symbols may be dsplayed sngly or several at once. When several symbols are dsplayed, each symbol can have ts own meanng. Alternatvely, the combnaton of symbols may mean somethng In the followng example you see a dsplay wth several symbols. Ths dsplay appears when you have turned on the meter to perform a blood glucose test Here each symbol has ts own meanng. The symbols shown along wth the tme and date mean: You can draw up blood or control soluton wth the test strp now. The batteres are runnng low. 12 You nserted a partly used test strp drum The beep tone or Acoustc Mode s set to on. 168 Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 169

86 In the tables presented below you wll frst see the meanngs of symbols that appear sngly or have the same meanng when they appear together wth other symbols. These are followed by the meanngs of combnatons of symbols and of symbols that appear n the numerc feld Sngle symbols Symbol Meanng 1 Draw up blood or control soluton wth the test strp now. 2 Durng a test and when the result s beng dsplayed: the temperature s outsde the permtted range of +10 C to +40 C. Do not use ths result as a bass for therapeutc decsons. Move to a place where the temperature s between +10 C and +40 C and wat for the temperature of the meter to adjust to ths temperature. Repeat the test wth a new test strp. Symbol Meanng In memory: at the tme of testng the temperature was outsde the permtted range. 3 The batteres are runnng low. When the symbol frst appears n the dsplay, you can perform about 50 more tests. If you use NMH rechargeable batteres nstead of normal batteres, fewer than 50 more tests can be performed. If the rechargeable batteres are old and exhausted, t may not be possble to perform even one more test. When the batteres are so low that no more tests can be performed, just the battery symbol appears brefly for 3 seconds n the dsplay. Then the meter turns off. Insert two batteres (new or recharged) Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 171

87 Symbol Meanng 4 See under Combnatons of symbols 5 The unt your meter uses to dsplay the blood glucose result, ether mmol/l or mg/dl (dependng on the meter). 6 The meter cannot calculate the use-by perod for ths test strp drum because you nserted a partly used test strp drum, because you opened the drum compartment cover, because the year, tme and date settngs were lost when you changed the batteres and at ths tme the drum was partly used (see Chapter 9). Symbol Meanng Only n a new meter that has not yet been used to perform tests: There s no test strp drum n the meter or the mock drum has been left nserted. Insert a new test strp drum (see Chapter 2.3). 7 Ths result s a performance check result. See under Combnatons of symbols 8 After testng: You have turned on the hypo ndcator and the dsplayed result s below the level you set. You are n the hypo ndcator settng. In memory: The result s below the lmt that was set at the tme of testng Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 173

88 Symbol Meanng 9 You are n the settngs. 10 Flag for a specal result, e.g. obtaned from alternate ste testng. 11 You have turned on at least one alarm or you are n the alarm clock settng. Optcal warnng whle the alarm sounds for 20 seconds. 12 The beep tone ( ) or Acoustc Mode ( ) s set to on. 13 The test strp has drawn up enough blood or control soluton, and test s runnng. 14 When an average s dsplayed (from memory): the symbol s preceded by the number of days covered. Symbol Meanng 15 You are n memory. Ether the saved result or one of the averages, hghest or lowest results s beng dsplayed. Durng averagng, when the calculaton s takng a whle. 16 Dsplayed addtonally when 12-hour tme format s selected. 17 When an average s dsplayed (from memory): the symbol s followed by the number of tests n ncluded n the calculaton Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 175

89 Combnatons of symbols The followng combnatons of symbols have meanngs of ther own. Symbols Meanng The 90-day use-by perod for the test strp drum has expred (see Chapter 2.3.1). The test strps cannot be used. Insert a new test strp drum. You must not use these test strps, as they may produce ncorrect results. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects See symbol combnaton After the symbol combnaton appeared, you performed a performance check, so the bottle symbol s no longer dsplayed. Symbols Meanng In memory: The test strp you used for ths test was unusable (the 90-day use-by perod had expred, see Chapter 2.3.1). The result n memory may be ncorrect. Incorrect results can cause the wrong therapeutc decson to be taken and so produce serous adverse health effects The meter s unable to calculate the useby perod for the test strp drum and s promtng you to perform a performance check, because you have just changed the batteres, the year, tme and date settngs have been lost (see Chapter 9) and, at the same tme, a partly used drum remans n the meter, Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 177

90 Symbols Meanng Symbols appearng n the numerc feld because you have just nserted a partly used test strp drum, because you have just opened the drum compartment cover. Perform a performance check (see Chapter 7). If the test produces a correct result, you may contnue to use the test strps. If the result s ncorrect, you need to nsert a new drum. Followng the performance check, the bottle symbol dsappears from the dsplay. The drum symbol contnues to be dsplayed n order to draw your attenton to the fact that the meter cannot calculate the use-by perod. The symbol only dsappears when you nsert a new test strp drum. All results are saved along wth the drum symbol. If you do not perform a performance check, the flashng bottle symbol appears wth every test untl you nsert a new drum. In the numerc feld: (mmol/l meter) or (mg/dl meter) the followng symbols may appear: Symbol Meanng 18 In memory: No results present n memory. Averagng s not possble because you have not set the tme and date, memory only contans results wthout a tme and date, memory only contans results that are not ncluded n the calculaton, e.g. performance results, no results were saved n the perod n queston, e.g. all results n memory are more than 7 days old, Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 179

91 Symbol Meanng the date that t s set s n the past, 12.2 Interferences and error messages causes and troubleshootng recommendatons you changed the tme and date, then performed a test and afterwards re-set the tme and date, but have not performed any more tests snce then. The result s lower than 0.6 mmol/l. The result s greater than 33.3 mmol/l. If you receve frequent error messages, please call Accu-Chek Customer Care at If ths happens The meter wll not turn on. t means: The batteres (normal or rechargeable) are empty or none are nserted. Insert batteres (new or recharged). You nserted the batteres the wrong way round. You have turned the meter on n order to download the results. The meter s downloadng results. Decmal pont dsplayed by mmol/l meters and s part of the result (e.g. 8.2 mmol/l s dsplayed as ) Remove the batteres and re-nsert them as shown n the battery compartment. If the batteres were n the meter the wrong way round for longer than two mnutes, the year, tme and date are now lost. Re-enter them (see Chapter 3) Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 181

92 If ths happens t means: The drum compartment cover s not properly closed. Close the drum compartment cover. It must close wth an audble CLICK. The ambent temperature s low and the batteres are almost empty. Move to a place where the temperature s between +10 C and +40 C and wat for the temperature of the meter to adjust to ths temperature. Insert batteres (new or recharged). Condensaton has affected the electroncs. Allow the meter to dry slowly. The meter s defectve. Please contact the Accu-Chek Customer Care Lne. If ths happens The meter s turned on, but the dsplay s blank. The clock has stopped or the clock s slow. When the meter s turned on, the date s shown as 0-00 and the tme s shown as 0:00. t means: The dsplay s defectve. Please call Accu-Chek Customer Care at The meter was exposed to a temperature below 10 C and the batteres are begnnng to freeze. Turn the meter off. Move to a place where the temperature s between +10 C and +40 C and wat for the temperature of the meter to adjust to ths temperature. The meter was exposed to a temperature below 10 C and the batteres are begnnng to freeze. Press the Test button to turn the meter off. Move to a place where the temperature s between +10 C and +40 C and wat for the temperature of the meter to adjust to ths temperature Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 183

93 Error message Meanng The year, tme and date have not been set. Set these as descrbed n Chapter 3. The test strp drum n the meter s empty. Insert a new test strp drum. The bar code nformaton from the test strp drum has been lost. Press the Test button to turn the meter off. Open and close the drum compartment cover. The meter rotates the drum and reads the bar code. When you next turn on the meter to perform a test, the drum symbol and flashng bottle symbol are dsplayed. Error message Meanng Perform a performance check. You may use up all the test strps remanng n the drum. The 90-day use-by perod wll no longer be calculated for ths drum. The drum symbol wll therefore be dsplayed each tme you perform a test untl you nsert a new test strp drum. The bar code on the test strp drum s damaged. You can no longer perform tests wth test strps from ths drum. Insert a new drum. The test strp drum does not rotate. Press the Test button to turn the meter off. Open the drum compartment cover and press the red drum release button. Close the drum compartment cover agan Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 185

94 Error message Meanng The meter rotates the drum and reads the bar code. When you next turn on the meter to perform a test, the drum symbol and flashng bottle symbol are dsplayed. Perform a performance check. You may use all the test strps remanng n the drum. The 90-day use-by perod wll no longer be calculated for ths drum. The drum symbol wll therefore be dsplayed each tme you perform a test untl you nsert a new test strp drum. The bar code on the test strp drum s damaged. You can no longer perform tests wth test strps from ths drum. Insert a new drum. Error message Meanng The measurng wndow s drty. Press the Test button to turn the meter off. Clean the measurng wndow (see Chapter 8.1) and repeat the test wth a new test strp. A test strp s stuck n the meter. Hold the meter uprght so the test strp s pontng downwards. Press the Test button to turn the meter off and allow the test strp to drop out. If the test strp does not drop out, remove t manually, even f you feel some resstance. The test strp drew up too lttle blood or control soluton. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp and a larger amount of blood or control soluton Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 187

95 Error message Meanng You drew up blood or control soluton too soon wth the test strp,.e. before the test strp symbol and drop symbol were flashng n the dsplay. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp. Only draw up blood or control soluton wth the test strp when the test strp symbol and drop symbol are flashng n the dsplay. You bent or moved the test strp durng the test ether whle you were drawng up blood or control soluton wth t or durng the test. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp. Error message Meanng The test strp that was advanced s defectve. Hold the meter uprght so the test strp s pontng downwards. Press the Test button to turn the meter off and allow the test strp to drop out. Press the Test button to turn the meter on agan and repeat the test. You pulled the test strp out of the meter. Press the Test button to turn the meter off. Only remove the test strp from the meter by pressng the Test button to turn the meter off. There s condensaton n the meter. Press the Test button to turn the meter off. Leave t to dry at room temperature Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 189

96 Error message Meanng The batteres (regular or rechargeable) are empty or a meter error has occurred. Turn the meter off and then on agan by pressng the Test button. If the error message appears agan, the batteres may be empty. Insert new batteres (new or recharged). If the error message s agan repeated when the meter turns on, please contact Accu-Chek Customer Care Lne. The meter was exposed to a strong electromagnetc feld. Press the Test button to turn the meter off. Move somewhere else or turn off the source of the feld. You bent or moved the test strp durng the test ether whle you were drawng up blood or control soluton wth t or durng the test. Error message Meanng Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp. You drew up blood or control soluton too soon wth the test strp,.e. before the test strp symbol and drop symbol were flashng n the dsplay. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp. Only draw up blood or control soluton wth the test strp when the test strp symbol and drop symbol are flashng n the dsplay. You pulled the test strp out of the meter durng testng. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp. Only remove the test strp from the meter by pressng the Test button to turn the meter off Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 191

97 Error message Meanng The test strp s stuck or the test strp drum does not rotate. Press the Test button to turn the meter off. Open the drum compartment cover and (f applcable) pull out the test strp. Press the red drum release button and remove the test strp drum. Insert the test strp drum agan and close the drum compartment cover. The meter rotates the drum and reads the bar code. When you next turn on the meter to perform a test, the drum symbol and flashng bottle symbol are dsplayed. Perform a performance check. You may use all the test strps remanng n the drum. The 90-day use-by perod wll no longer be calculated for ths drum. The drum symbol wll therefore be dsplayed each tme you perform a test untl you nsert a new test strp drum. Error message Meanng The meter has been exposed to severe dfferences n temperature. The ambent temperature or the temperature wthn the meter s too low (below +6 C) or too hgh (above +44 C) for a test. Press the Test button to turn the meter off. Move to a place where the temperature s between +10 C and +40 C and wat for the temperature of the meter to adjust to ths temperature. The test strp drew up too lttle blood or control soluton. Turn the meter off and then on agan by pressng the Test button. Repeat the test wth a new test strp and a larger amount of blood or control soluton Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 193

98 Error message Meanng There s no test strp drum n the meter. Error message Meanng In memory: the result n memory cannot be dsplayed. Press the Test button to turn the meter off. Insert a new test strp drum (see Chapter 2.3). All other results n memory can contnue to be retreved wth the M or S button. The bar code on the test strp drum s damaged. You can no longer perform tests wth test strps from ths drum. Insert a new drum. You nserted a test strp drum from a dfferent blood glucose measurng system. Press the Test button to turn the meter off. Insert an Accu-Chek Compact test strp drum (see Chapter 2.3). A meter error has occurred. Turn the meter off and then on agan by pressng the Test button. If the error message perssts, please contact Accu-Chek Customer Care Lne Symbols, error messages and troubleshootng Symbols, error messages and troubleshootng 195

99 13 Techncal data Meter type Accu-Chek Compact Plus (Model GT) Catalogue No./Seral No.See type plate on the back of the meter Test prncple Determnaton of glucose n fresh capllary blood by reflectance photometry. When usng dfferent specmen materal please refer to the package nsert that came wth the Accu-Chek Compact test strps. Blood glucose concentratons may be measured n whole blood or n plasma. Although you always draw up whole blood wth the test strp, your meter dsplays blood glucose results that relate ether to whole blood or to plasma. To see whether your blood glucose meter dsplays results relatng to whole blood or to plasma, please read the package nsert that came wth your test strps. There you wll also fnd nformaton on how the system works, on the test prncple and on reference methods. Measurng range mmol/l ( mg/dl) Sample sze approx. 1.5 μl (1 μl (mcroltre) = 1 thousandth of a mllltre) Measurng tme approx. 5 seconds (dependng on concentraton) System operatng temperature +10 C to +40 C Storage temperature Meter wthout batteres and wthout a test strp drum: -25 C to +70 C wth batteres and wthout a test strp drum: -10 C to +50 C wth batteres and wth a test strp drum: +2 C to +30 C Lancng devce -25 C to +70 C Humdty durng testng 20 % to 85 % relatve humdty durng storage 20 % to 85 % relatve humdty Alttude Sea level to 4000 m Memory 500 results together wth tme and date, averages, hghest and lowest value for 7, 14 and 30 days Dmensons wthout lancng devce mm wth lancng devce mm Techncal data Techncal data 197

100 Weght Dsplay wndow Automatc power-off approx. 147 g wth lancng devce, batteres and test strp drum OLED (Organc Lght Emttng Dode) dsplay after 60 seconds or 5 mnutes dependng on operatng status Power supply 2 batteres (type AAA, LR 03, AM 4 or Mcro) or 2 NMH rechargeable batteres (type AAA) Battery lfe approx results or approx. 1 year (less when the brghtness of the dsplay s set to level 3 (hgh), or n Acoustc Mode owng to the hgher power consumpton, or when rechargeable batteres are used) Interface Infrared nterface Safety class III LED/IRED Class 1 Electromagnetc compatblty Ths devce meets the electromagnetc mmunty requrements accordng to EN ISO Annex A. The chosen bass for the mmunty tests (on electrostatc dscharge) was basc standard IEC In addton t meets the electromagnetc emssons requrements accordng to EN Its electromagnetc emsson s thus low. Interference from other electrcally powered equpment s not to be antcpated. Performance evaluaton The performance data for the Accu-Chek Compact Plus system (Accu-Chek Compact Plus meter together wth Accu-Chek Compact test strps) were determned usng capllary blood from patents wth dabetes (method comparson, accuracy), venous blood (repeatablty) and control solutons (reproducblty). The system s calbrated wth venous blood contanng varous levels of glucose. The reference values are obtaned usng the hexoknase method. The method comparson was conducted by comparng the results from the system wth those of the hexoknase method wth deprotenaton usng an automatc analyzer. The hexoknase method s traceable to a NIST standard (traceablty). The Accu-Chek Compact Plus system comples wth the requrements of EN ISO Techncal data Techncal data 199

101 14 Alternate stes testng Capllary blood for blood glucose testng can be obtaned, not only from the fngertps, but also from other stes (the palm, the forearm, the upper arm, the calf or the thgh), whch s referred to as Alternate Ste Testng (AST). The Accu-Chek Softclx Plus AST cap s a specal cap that s used n conjuncton wth the Accu-Chek Softclx Plus lancng devce and enables you to collect blood from these alternate stes. Blood obtaned from a fngertp and the palm both below the thumb and below the lttle fnger can be used at any tme to test blood glucose. If blood from any of the other alternate stes the forearm, the upper arm, the calf and the thgh s used, there are certan tmes when testng s not approprate (see the chapter The rght moment ). The results may dffer from the results taken from the fngertps at these tmes. These dfferences can cause the wrong therapeutc decson to be taken and so produce adverse health effects. The AST cap s ntended for patent self-montorng by a sngle person. Ths cap must not be used for obtanng blood on more than one person owng to the rsk of nfecton. Please read these nstructons for use before you use blood from alternate stes to test blood glucose. Only n ths way can you choose the rght blood collecton method. Before you decde to practce alternate ste blood glucose testng, please consult your healthcare professonal. 200 Alternate stes testng Alternate stes testng 201 Before usng the AST cap, please carefully read the nstructons for use of the Accu-Chek Compact Plus meter and the package nsert of the Accu-Chek Compact test strp drums. Use the AST cap to obtan blood from alternate stes only. If you use ths AST cap to collect blood from a fngertp, the lancet penetrates too deeply nto the fnger and could possbly cause unnecessary dscomfort or pan. In rare nstances brusng may occur followng collecton of blood from alternate stes. If the result usng blood taken from the forearm, the upper arm, the calf or the thgh produces a result that does not agree wth the way you feel, test agan wth blood collected from a fngertp or the palm. If the test result stll does not agree wth the way you feel, please contact your healthcare professonal. Do not change your treatment based only on a sngle result. Only use the AST cap n conjuncton wth the Accu-Chek Softclx Plus lancng devce. Usng a dfferent lancng devce or usng a dfferent AST cap wth the Accu-Chek Softclx Plus lancng devce can prevent the lancng devce and/or the AST cap from functonng properly or may result n damage to the lancng devce and/or AST cap. The success of obtanng a sutably szed drop of blood from alternate stes may dffer from person to person and from ste to ste. 14

102 14.1 Choosng the rght moment Alternate Stes for Testng Before you test wth blood collected from the forearm, the upper arm, the calf or the thgh, be aware of the followng lmtatons: Capllary blood n the fngertp and the palm responds more quckly to changes n blood glucose levels than blood n the forearm, the upper arm, the calf and the thgh. Blood glucose values tested n blood taken from these stes may therefore dffer from values tested n blood taken from the fngertp and palm. The dfference n the blood glucose values s partly because the fngertps and the palm contan more blood vessels than other stes. Do not test blood from the forearm, the upper arm, the calf and the thgh: up to two hours followng a meal, when blood glucose values can change quckly after exercse f you have a temperature or f a medcal condton s lmtng your moblty, e.g. after breakng a leg or beng confned to bed f you suspect that your blood glucose s extremely low (hypoglycema) f you know that you sometmes do not notce when you are hypoglycemc durng peak acton tme of short-actng nsuln (up to approxmately 4 hours after the njecton) or rapd-actng nsuln analogues (up to approxmately 2 hours after the njecton) Palm of the hand below the thumb Palm of the hand below the lttle fnger Insde of the forearm Upper arm Outsde of the forearm Calf Thgh preferred alternatve stes 202 Alternate stes testng Alternate stes testng

103 14. 2 Obtanng blood and testng blood glucose 1. Remove the coloured cap from the lancng devce. 2. Insert a new lancet nto the lancng devce as descrbed n the nstructons for use of the Accu-Chek Compact Plus meter. 3. Attach the clear plastc AST cap. As wth the coloured cap, the locatng notch n the cap (1) must be drectly algned wth the locatng lne on the lancng devce (2). The AST cap must clck nto place. For blood collecton, the AST cap must be on the lancng devce. Wthout ths cap, the lancng devce cannot be prmed, nor can the lancet be trggered. Instead, the lancet s ejected when you press the plunger. 4. Rotate the cap untl you reach your chosen penetraton depth. To obtan a suffcently large drop of blood from alternate stes, lancng must be deeper than on the fngertps. However, these stes are usually less panful. 5. Choose a fleshy area of the alternate ste for blood collecton and wash t wth warm, soapy water. Ths ensures that the puncture ste s clean. Allow the skn to dry thoroughly. 6. Prme the lancng devce. 7. Press the AST cap frmly aganst the selected puncture ste. 8. Press the plunger all the way down. Ths trggers the lancet, whch penetrates the skn. 9. Keep the lancng devce pressed aganst the puncture ste for a few seconds. You can watch the drop of blood form through the AST cap. The drop of blood should be approxmately ths sze: If the drop s smaller, release the pressure for a few seconds, wthout removng the lancng devce from the puncture ste. Then re-apply pressure on the lancng devce untl you get a suffcently large drop of blood. Too much blood emergng can contamnate the AST cap. For hygenc reasons, the AST cap should be cleaned mmedately after testng your blood glucose (see chapter Cleanng the AST cap ). 10. Press the Test button to turn the meter on Alternate stes testng Alternate stes testng 205

104 11. Wat untl the test strp symbol and drop symbol flash n the dsplay. 12. Hold the meter so the test strp s pontng downwards. 13. Hold the tp of the test strp aganst the drop of blood so the black notch s touchng the drop of blood. The test strp draws up blood. The test starts when the test strp has drawn up suffcent blood. The result s dsplayed as soon as the test s complete. At the same tme the meter automatcally saves the result to memory. You can flag results obtaned from alternate ste testng as specal results wth an astersk. Please consult the nstructons for use of the meter for nformaton on how to flag results. 14. Hold the meter over a waste bn wth the test strp pontng downwards. 15. Press the Test button to turn the meter off. The used test strp drops out. 16. Remove the AST cap from the lancng devce and dspose of the used lancet. Carefully dspose of used lancets so that the needles cannot cause njury. 17. Place the coloured cap back on the lancng devce Cleanng the AST cap Follow a weekly cleanng regme usng a cloth mostened wth 70 % ethanol or 70 % sopropanol (avalable n pharmaces). In addton, thoroughly wpe the nsde of the AST cap usng a cotton bud mostened wth one of the two cleanng fluds mentoned. Allow the AST cap tme to dry thoroughly. Never dp the AST cap n the cleanng flud. Cleanng flud left n contact wth the AST cap for too long can attack the materal from whch t s made, stoppng t from functonng properly. Use only 70 % ethanol or 70 % sopropanol to clean the AST cap. Other substances used for cleanng may attack the plastc and stop the cap from functonng properly Alternate stes testng Alternate stes testng 207