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5.

58

59

5. Checking the performance of

Accutrend

®

GC

5.1 Checking the measurement system

In order to obtain reliable results you must check the perfor-
mance of your meter at certain times. A performance check
should be carried out:

once a week if you use the meter regularly and
frequently, e.g. for blood glucose self-monitoring,

whenever you start a new pack of test trips and there-
fore recode the meter (which can lead to a change in
the code),

whenever you have changed the batteries,

after cleaning the meter,

whenever you obtain a doubtful reading,

in the medical setting, according to the guidelines or
regulations for quality control measurements applying
in your surgery or laboratory.

You will need the following:

Accutrend

®

GC meter.

Accutrend

®

Glucose and Cholesterol test strips.

011553 AccuGC GB  19.02.2002  10:40 Uhr  Seite 58

Содержание Accutrend GC

Страница 1: ...l MEM memory seT setting am morning pm afternoon lo low value below measurement range hi high value above measurement range e eee error cl clear delete all all on on off off outside range Last updated October 2000 Roche Diagnostics GmbH D 68298 Mannheim Germany www roche com Accutrend Accu Chek and Softclix are trademarks of a Member of the Roche Group 0088 10 00 1432079 65 User s Manual P O I N T...

Страница 2: ...explained fully in the manual It is best to have your instrument next to you while reading the manual and to try out each step as it is described Back view MEM ON OFF seCODE MEM LOW BAT mg dl Accutrend GC Front view Front view open D A B C F E J K H L G 011553 AccuGC GB_Umschlag 19 02 2002 11 12 Uhr Seite U4 ...

Страница 3: ...p Protects the optics E Measurement window The measurement is carried out here F Slot for test strip The test strip is inserted in the slot at the bottom of the meter G Test strip guide Holds the test strip in the correct position H Battery compartment lid J Beeper button K SET button for time and date L Connector for data transmission 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 1 ...

Страница 4: ...lts from memory 49 4 3 Deleting results from memory 53 5 Checking the performance of Accutrend GC 59 5 1 Checking the measurement system 59 5 2 Cleaning the meter 71 5 3 Battery life and changing the batteries 75 5 4 Measurement and storage conditions 77 6 Troubleshooting 81 6 1 Error messages and important displays 81 6 2 Possible causes of errors 96 6 3 Roche Diagnostics service 97 7 Additional ...

Страница 5: ...he alphabet are referred to frequently in the text The fold out page is a helpful orientation Warning You will find this sign when there is a poten tial danger to health e g the danger that you might calculate the insulin dose incorrectly Caution You will find this sign when there is a dan ger that you might damage the device e g through improper cleaning Please read this manual carefully and comp...

Страница 6: ...end GC is supplied with three AAA alkaline manganese batteries The batteries must be inserted before using the meter Procedure for inserting changing the batteries Always switch off the Accutrend GC before inserting or changing the batteries Then turn the meter over and hold it with both hands Slide the battery compartment lid H gently in the direction of the arrow using both thumbs and remove Acc...

Страница 7: ...pressed during this time 2 2 Switching on the meter for the first time After you have inserted the batteries you can switch on the meter using the ON OFF switch C Immediately after switch ing on the meter always performs an automatic function test lasting about 2 seconds checking all instrument functions and display elements No entries can be made during this test The automatic function test is pe...

Страница 8: ...ask your doctor If the unit you are familiar with does not appear in the display please ask your dealer to exchange the instru ment Make sure that all three digits of the display appear as 888 If any of the lines making up these digits are missing the values displayed later might be incorrect If at any time during the function test the display does not correspond to either of the diagrams on the l...

Страница 9: ...to be stored with the important information date and time these must first be set correctly The time can be displayed in either the 12 hour or 24 hour for mat If the 12 hour format is chosen the time is displayed as numbers from 1 to 12 with the addition of AM before 12 noon or PM after 12 noon e g PM 3 43 If the 24 hour format is chosen the time is displayed in num bers from 1 to 24 e g 15 43 The...

Страница 10: ...ppears on the display A Briefly press the SET button K below the clock symbol using a ballpoint pen for example Time and date begin to flash in the display To change the display from the 24 hour to the 12 hour clock format gently lift up the flap D and press the rocker button MEM B AM or PM appears on the display 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 14 ...

Страница 11: ...t the day in the same way as the hour Press the SET button briefly The month flashes on the display Keep pressing MEM to set the month in the same way as the hour Store the changes by closing flap D or by pressing the ON OFF button C Your settings will be stored automatically Leap year In a leap year the date will not change automatically from 28 02 to 29 02 but to 01 03 In order to change the dat...

Страница 12: ...er if you find the sound annoying you can switch off the beeper as follows Procedure for switching the beeper on and off Switch on the meter with the ON OFF button C and wait until the function test is complete Open flap D seT appears on the display A Press the beeper button J briefly using a ballpoint pen The bell symbol disappears Close the flap Switch off the meter The setting will be stored au...

Страница 13: ... characteristics of the respective Accutrend Glucose and Accutrend Cholesterol strips used Accutrend GC must be coded After switching on for the first time when no code number is stored in the meter Whenever a new pack of test strips is used The instrument is coded only for the pack from which you take the test strips for the measurement of blood glucose or cholesterol Individually wrapped code st...

Страница 14: ...the code number it has stored If the wrong test strip is inadvertently used the error message e 1 appears TGLUCHOL seCODE EV TGLUCHOL seCODE EV 2044277 60 V4 1 2 Glucose mg dl Glucose γλθκόζης 50 2 7 250 13 8 600 33 3 0 0 neg mg dl mmol l Accutrend mini Accutrend GC GCT DM Accutrend alpha ACCUTREND mmol l Accutrend Control G REF 1443054 30 C 2 C LOT IVD CODE ΚΩ ΙΚΟΣ 50 TESTS Μετρήσεις 50 90 156 22...

Страница 15: ... black horizontal line With the flap D closed insert the code strip into the slot F in one smooth brisk movement as far as it will go then withdraw the strip immediately If the beeper is switched on successful coding is acknowledged by a beep The display shows a three digit code number The code has been read in and stored If the error message e 2 or e 3 appears coding was unsuccessful see Section ...

Страница 16: ...y switches to the cor rect symbol for the strip After coding do not throw away the test strip in case recoding is necessary later on Store the code strip in its wrapping and not in the test strip container because the print on the code strip may impair test strip quality and lead to erroneous results seCODE GLUC seCODE CHOL 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 26 ...

Страница 17: ...The Accutrend GC meter which you have already coded you have also set the time date and beeper Accutrend test strips Accutrend Glucose for blood glu cose measurement Accutrend Cholesterol for determina tion of cholesterol A lancing device e g Accu Chek Softclix Pro with Accu Chek Softclix Pro Lancet Possibly alcohol wipes and cellulose pads Procedure Carefully read the pack inserts that come with ...

Страница 18: ...r GLUC and CHOL alternately if the meter has been coded for both The corresponding code number the time and the date appear below The word CODE flashes and the Accutrend GC is now ready for the measurement of the coded parameters Take a test strip out of the test strip container Close the container immediately otherwise the desiccant in the stopper will be exhausted and the test strips will become...

Страница 19: ...nt time in seconds flashes on the display 12 sec for GLUC 180 sec for CHOL Rub and knead the side of a fingertip to facilitate the withdrawal and application of blood Lance the massaged site with the lancing device With the test strip still in the meter allow a hanging drop of blood to form without applying too much pres sure For determination of cholesterol wipe off the first drop of blood with a...

Страница 20: ...ue in mg dl or mmol l appears on the display A The result is stored Accutrend GC measures values only within certain ranges glucose 20 600 mg dl 1 1 33 3 mmol l cholesterol 150 300 mg dl 3 88 7 76 mmol l If the value obtained is above these ranges the meter displays hi high if the value obtained is below these ranges the meter displays lo low The meter also displays lo when too little blood is app...

Страница 21: ...in the meter Accutrend GC switches off after 2 minutes The result is neverthe less stored For blood glucose measurements only perform a colour comparison to check plausibility a Turn over the test strip b Compare the colour in the round window with the colour scale on the label of the test strip container The colour in the round window must approximately match the colour given for your result and ...

Страница 22: ...t the meter is functioning properly please consult your doctor for advice Close the flap and switch off the meter The used test strips and other consumables e g cleansing pads lancets should be disposed of as household waste In the medical setting e g laboratory or doctor s surgery the relevant regulations or guidelines for the disposal of potentially infec tious materials must be observed 2044277...

Страница 23: ...nd there is a risk of infection In order to prevent infection e g hepatitis or AIDS it is essential to observe the following points Only apply the blood outside the meter Follow the instructions in the section Procedure for measurement on several people below Use a separate lancet and lancing device for each person We recommend using the Accu Chek Softclix Pro lancing device and Accu Chek Softclix...

Страница 24: ... 3 2 Repeat the described procedure for the next person to be test ed using a new piece of paper towel or similar absorbent material If Accutrend GC is used for performing measurements on sev eral people and the blood is always applied to the strip using an application device e g capillary pipettes the sample may also be applied with the test strip in the instrument see Section 3 2 In this case a ...

Страница 25: ...The relevant regulations or guidelines applying to your institute or laboratory should be observed The used test strips and consumables e g lancets swabs are to be disposed of as potentially infectious waste according to the relevant regulations or guidelines applying to your institute or laboratory 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 44 ...

Страница 26: ...terol values in the CHOL directory All values stored in the memory MEM can be retrieved or deleted When you perform a measurement the Accutrend GC auto matically stores this latest result in the position 01 in the cor responding directory The previous value is moved automati cally to position 02 Thus the higher the number of the memory position the older the value occupying this position When all ...

Страница 27: ...memory Select the relevant directory by pressing MEM for glucose values or MEM for cholesterol values If no results have been stored the display will show 00 If 01 is displayed this means that there is at least 1 value in the memory Release the MEM button The last result stored will appear on the display e g e g GLUCHOL seCODE CHOL seCODE MEM 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 48 ...

Страница 28: ... run through all memory positions When all positions have been shown the display returns to 01 To count down from any value stored press the button MEM To terminate the retrieval procedure press the ON OFF button C e g GLUC MEM GLUC MEM mg dl GLUC MEM MEM 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 50 ...

Страница 29: ...rectory Note that these two steps can only be performed one after the other in the given order Clearing the most recent value stored Switch off the meter While holding down the MEM button for the glucose values or the MEM button for the cholesterol values briefly press the ON OFF button C Release the MEM button MEM flashes in the dis play A and cl1 appears MEM ON OFF GLUC MEM 011553 AccuGC GB 19 0...

Страница 30: ...nd The most recent value measured flashes during these 3 seconds until it is cleared and 000 appears in the display A Release the rocker button MEM cl2 appears in the display indicating that all values in this directory can be cleared To terminate the clearing procedure briefly press the MEM button or simply switch off the meter with the ON OFF button C GLUC MEM mg dl mg dl GLUC MEM mg dl MEM 0115...

Страница 31: ...n MEM and hold down for at least 3 seconds If the beeper is switched on a series of beeps is heard one beep per second The word all flashes during these three seconds until the entire contents of this directory have been cleared and 000 appears in the display Release the MEM button The code number and CODE appear in the display MEM GLUC MEM mg dl 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 56 ...

Страница 32: ...elf monitoring whenever you start a new pack of test trips and there fore recode the meter which can lead to a change in the code whenever you have changed the batteries after cleaning the meter whenever you obtain a doubtful reading in the medical setting according to the guidelines or regulations for quality control measurements applying in your surgery or laboratory You will need the following ...

Страница 33: ...the test strips and control solution Switch on Accutrend GC The meter first checks the electronics for about 2 sec onds as mentioned under 2 2 and then the word GLUC or CHOL appears in the display These different blood components are also called parameters The corresponding code number the time and the date appear below the parameter name The word CODE flashes Accutrend GC is now ready to measure ...

Страница 34: ...to the instructions given there If the inserted test strip is not shown correctly on the display e g if you have inserted an Accutrend Glucose test strip but GLUC is not displayed switch off the meter and start again Open the flap D The measurement time in seconds flashes in the display Leave the test strip in the meter Apply a large hanging drop of control solution to the yellow test pad on the s...

Страница 35: ...ay now counts down in seconds to 0 During the last four seconds a series of beeps is heard one beep per second followed by a longer beep at the end of the measurement The measured value appears in the display A GLUCHOL mg dl TGLUCHOL seCODE 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 64 ...

Страница 36: ...e lot d Accutrendn Control CH 1 suivants Los intervalos de dispersión indicados abajo sólo valen para los siguientes lotes de Accutrendn Control CH 1 Os intervalos de referência abaixo indicados apenas dizem respeito aos seguintes lotes de Accutrendn Control CH 1 Gli intervalli di riferimento riportati qui di seguito si riferiscono esclusivamente alle soluzioni di controllo Accutrendn Control CH 1...

Страница 37: ... is performed N B 1 The instrument may switch itself off before you have insert ed the test strip if no button has been pressed for about 60 seconds If this happens switch the Accutrend GC back on and start again 2 You may have to clean Accutrend GC after practising for example if the measuring optics have become soiled In this case please refer to Section 5 2 and proceed as described there 204427...

Страница 38: ...ion to the flap D and to the test strip guide G if the control value is outside the specified range see Section 5 1 whenever you open a new pack of test strips if someone else has used the meter Procedure for cleaning Accutrend GC Check that the meter is switched off Clean the outside with a damp lint free cotton cloth Remove the test strip guide G To do this open the flap D push the black guide g...

Страница 39: ...alcohol is used for disinfection of meters used in the medical sector the alcohol should be wiped off again immediately after application Use only 70 ethyl alcohol for disinfection as other agents may damage the plastic Now insert the completely dry test strip guide G into the meter and press down gently until it clicks into place Make sure that the meter functions properly after cleaning by perfo...

Страница 40: ... memory will be lost You should therefore change the batteries as soon as possible after LOW BAT first appears Changing the batteries Always change all three batteries at the same time It is ad visable to always have a complete set of three batteries in reserve Use micro LR 03 type batteries e g UCAR Micro 1 5 V AAA KODAK Micro or VARTA Micro AAA If the batteries are changed within 2 minutes no da...

Страница 41: ...s performed at a temperature outside the ranges given above the safety warning TTT flashes on the display in alternation with the measured value The reading was obtained under temperature condi tions outside the admissible range It must therefore be interpreted with particular caution and may only be used for orientation Allow the meter and test strips to adjust slowly to room tem perature Never t...

Страница 42: ... Possible sources of interference Interference e g frequent display of the safety warning eee cannot be ruled out in the presence of strong magnetic fields such as those induced by transmitters CB radio devices radios televisions household electrical appliances micro wave ovens high frequency equipment and particularly mobile telephones It is advisable to keep the meter at least two meters away fr...

Страница 43: ...ee Section 2 Humidity is too high Move the meter to a dry environment and wait a while before switching it on again The meter is defective Contact the Roche Diagnostics service centre No code stored Code the meter see Section 3 1 Display remains empty when you switch on the instrument Display window 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 80 ...

Страница 44: ...ll test strips The admissible temperature range is 18 C to 32 C for Accutrend Glucose and 18 C to 30 C for Accutrend Cholesterol Accutrend GC offers an additional safety warning if a measurement is per formed outside the above temperature ranges the warning TTT flashes alternately with the result The reading may only be used for orientation Let the meter and test strips adjust slowly to room tempe...

Страница 45: ...ed Use only Accutrend Glucose or Accutrend Cholesterol test strips The reading in of the code has failed Repeat the coding procedure see Section 3 1 The test strip was not properly inserted Open the flap take out the strip close the flap and insert the strip again The flap was open during measurement Repeat the entire measuring procedure with a new test strip and with the flap closed see Section 3...

Страница 46: ...code strips A strong magnetic field is affecting the meter Move the meter to a different place see Section 5 4 The optics are dirty or the meter is defective Clean the meter see Section 5 2 and repeat the measurement If the problem persists contact the Roche Diagnostics service centre see Section 6 3 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 86 ...

Страница 47: ...y does not appear in every case Repeat the measurement using a fresh test strip and a larger drop of blood The value is above the Accutrend GC measuring range GLUC blood glucose above 600 mg dl 33 3 mmol l CHOL cholesterol above 300 mg dl 7 76 mmol l Measurement performed without a test strip Insert a test strip for measurement immediately after applying the drop of blood GLUC GLUC 011553 AccuGC G...

Страница 48: ... the strip with the colour scale on the label of the Accutrend Glucose test strip container The yellow colour of the round window on the back of the strip should match the yellow colour indicating neg on the label If the colour of the test window is darker the test strip may not be used The test strip guide is dirty Clean the guide carefully see Section 5 2 No blood was applied to the test strip R...

Страница 49: ...rature range Allow the meter and the test strips to adjust to room temperature slowly Never try to speed up the temperature adjustment by placing on a radiator or in the refrigerator Ready for deletion of the most recent result from memory Ready for deletion of all results from a directory GLUC mg dl 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 92 ...

Страница 50: ...95 All results will be deleted from the memory within three seconds unless the MEM button is released earlier Ready for setting the date and time or the beeper 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 94 ...

Страница 51: ...about what to do if implausible values are obtained or if the meter is thought to be defective please contact our advisory service The staff there will try to help you solve the problem A list of Roche Diagnostics representatives in the different countries is given in Section 8 4 Repair service Please note that any repairs or adjustments to the meter or any further modifications should only be car...

Страница 52: ...ic reaction with formation of a dye the amount of dye formed increasing with the concentration of the substance to be determined After a certain period of time which is dependent on the test being performed the meter measures the colour intensity This is done by directing light from an LED towards the test area from below and measuring the intensity of the reflected light with a detector For calcu...

Страница 53: ... For further information on this please contact Roche Diagnostics 8 General information 8 1 Technical data Type Accutrend GC Serial No See name plate on underside of instrument Measurement principle Determination of glucose or cholesterol in fresh capillary blood by reflectance photometry Optical system LED 657 nm Measurement range Glucose 20 600 mg dl 1 1 33 3 mmol l Cholesterol 150 300 mg dl 3 8...

Страница 54: ... least 1000 measurements Storage conditions Temperature 25 C to 65 C Relative humidity below 85 Disposal The outer packaging can be disposed of as household waste For disposal of the meter the rele vant legal regulations should be observed after consultation of your local community if applica ble This product fulfils the require ments of Directive 98 79 EC on in vitro diagnostic devices This Accut...

Страница 55: ... at our discretion to repair faulty components free of charge or provide a fault free replacement meter Statutory and other rights The manufacturer s warranty given above is in addition to any statutory or other rights granted through your dealings with the instrument supplier 8 4 International addresses Roche Diagnostics GmbH D 68298 Mannheim Germany Tel 49 6 21 7 59 46 46 Roche Diagnostics Austr...

Страница 56: ...ields 79 Measurements on several persons 41 Measuring principle 99 Measuring range 35 101 Measuring time 33 Memory capacity 47 101 Roche Diagnostics K K Nippon Roche Building 6 1 Shiba 2 chome 105 0014 Minato ku Tokyo JAPAN Roche Diagnostics Asia Pacific Pte Ltd 298 Tiong Bahru Road 16 01 06 Tiong Bahru Plaza Singapore 168730 Tel 652727500 Roche Products Pty Ltd South Africa Diagnostics Division 9...

Страница 57: ...tising measurement 29ff 59 Retrieval of results from memory 49ff Storage conditions 77 Switching on 9 Symbols 4 5 Technical data 101 102 Test procedure 29ff Test strip 29 103 Test window 37 69 Time 13 Units of measurement 11 Warranty 104 011553 AccuGC GB 19 02 2002 10 40 Uhr Seite 108 ...

Страница 58: ...workmanship which occur on proper use of the instrument and occur and are reported during the warranty period The warranty ceases to apply if the instrument is damaged by tampering misuse or negligent maintenance Our liability under this warranty is limited to the repair of defective parts or to the provision at our option of acorrectly functioning replacement instrument This warranty is only vali...

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