Roche Accu-Chel Manuale di Servizio

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ACCU-CHEK is a trademark of Roche.
Roche Diagnostics GmbH
68298 Mannheim, Germany
www.accu-chek.com
0 5241430001(02)2008-05
Blood Glucose Meter
Instructions for use
R4 406 – 3400
V6/1 – Man_05241430001_02_EN_148x105mm Black
V6/2 – Man_05241430001_02_EN_148x105mm Cyan
V6/3 – Man_05241430001_02_EN_148x105mm Magenta
V6/4 – Man_05241430001_02_EN_148x105mm Yellow
V6/5 – Man_05241430001_02_EN_148x105mm PMS 5445
V6/6 – Man_05241430001_02_EN_148x105mm PMS 327
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Sommario

Pagina 1 - Instructions for use

0088 ACCU-CHEK is a trademark of Roche. Roche Diagnostics GmbH 68298 Mannheim, Germany www.accu-chek.com0 5241430001(02) – 2008-05Blood Glucose Met

Pagina 2

9 Changing the battery 8710 Testing blood glucose in more than one patient – Information for healthcare professionals 9110.1 Testing blood gluc

Pagina 3 - Intended use

100Symbols, problems and error messagesSymbols, problems and error messages12 In addition to test results, time and date other sym-bols and error mess

Pagina 4

110111213141516171823456789101Symbols, problems and error messages12.1 Symbols shown in the display1 You are in the test-result memory. Either a save

Pagina 5

102Symbols, problems and error messages3 You are in the settings for time and date.4 When an average is displayed (test-result memory): the symbol is

Pagina 6

103Symbols, problems and error messages10 + 11 (ashing)The test strip was removed from the meter before blood or control solution was applied, for ex

Pagina 7 - Contents

104Symbols, problems and error messagesDo not use the result as a basis for therapeutic decisions. Ensure that the ambient temperature is between +10

Pagina 8

105Symbols, problems and error messagestogether with :Averages cannot be calculated because you have not set the time and date, only test results w

Pagina 9

106Symbols, problems and error messages The result is higher than 600 mg/dL (33.3 mmol/L). Repeat the test. Decimal point: displayed by mmol/L meters

Pagina 10

107Symbols, problems and error messages12.2 ProblemsThe meter will not turn on. You have not removed the protective lm from the battery. Remove th

Pagina 11

108Symbols, problems and error messagesThe meter is turned on, but the display is blank.The display is defective.Please contact your customer support

Pagina 12 - Getting to know your meter1

109Symbols, problems and error messages12.3 Error messagesIf an error message is displayed, turn the meter off. Depending on the situation, either by

Pagina 13

13 Technical data 11614 Disposing of your meter 12115 System components 12216 Patents 12317 Customer support and service 12417.1 Info

Pagina 14

110Symbols, problems and error messages You did not insert the test strip correctly or completely. Hold the test strip so the arrows printed on it a

Pagina 15

111Symbols, problems and error messages The code chip cannot be read.Remove the code chip and re-insert it into the meter. If the error message appe

Pagina 16 - Steps before testing2

112Symbols, problems and error messages You have inserted a used test strip into the meter.Start again from the beginning with an unused test strip.

Pagina 17

113Symbols, problems and error messages You removed the code chip while testing was in progress.Re-insert the code chip into the meter and repeat th

Pagina 18

114Symbols, problems and error messagesA meter error has occurred. Start again from the beginning. If the error message appears again, the meter is de

Pagina 19 - Press at the same time

115Symbols, problems and error messagesThe ambient temperature or the temperature of the meter is too low or too high for a test. Ensure that the ambi

Pagina 20

116Technical dataTechnical data13 Meter type Accu-Chek Active (Model GC)Catalogue no./Serial no. See type plate on the back of the meterTest principl

Pagina 21 - Setting the time and date3

117Technical dataMeasuring range 10–600 mg/dL (0.6–33.3 mmol/L)Sample size 1–2 µL (1 µL (microlitre) = 1 thousandth of a millilitre)Measuring time ap

Pagina 22 - 3.1 Overview

118Technical dataTemperatureduring testingduring storagewithout batterywith battery+10 to +40 °C-25 to +70 °C-10 to +50 °CAtmospheric humidityduring t

Pagina 23 - Press briey at the

119Technical dataDisplay 96-segment liquid crystal display (LCD)Interface infrared portSafety class IIILED/IRED Class 1Electromagneticcompatibilit

Pagina 24 - 3.2 Making settings

8756432112Getting to know your meterGetting to know your meter1 1.1 Your meter at a glance1 Display 2 S button (retrieving settings for time and date

Pagina 25

120Technical dataPerformance analysis The performance data for the Accu-Chek Active system (Accu-Chek Active meter with Accu-Chek Active test strips)

Pagina 26

121Disposing of your meterDisposing of your meter14 During blood glucose testing the meter itself may come into contact with blood. Used meters theref

Pagina 27

122System componentsSystem components15 The Accu-Chek Active blood glucose monitoring system comprises the following components in addition to the met

Pagina 28 - Coding4

123PatentsPatents16 US 5,366,609; US 5,424,035; US 5,463,467; US 5,889,585; US 6,055,060; US 6,906,802

Pagina 29

124Customer support and serviceCustomer support and service17 17.1 Information service and troubleshootingFor questions on how to operate your Accu

Pagina 30 - Testing blood glucose5

125Customer support and servicePT. Roche Indonesia. Diagnostics Division.Gedung Artha Graha, lt.21. SCBD - Lot 25.Jl.Jendral Sudirman Kav. 52-53. Jaka

Pagina 31 - 5.2 Testing blood glucose

126Customer support and serviceRoche Diagnostics Asia Pacic Pte. Ltd 298, Tiong Bahru Road#16-01/06 Central PlazaSingapore 168730, SingaporeRoche Pro

Pagina 32

127Alphabetical indexAlphabetical index18 AAlternative sites 40Apple (symbol) 40, 103Apple core (symbol) 40, 103Asterisk (symbol) 40, 102Atmos

Pagina 33

128Alphabetical indexCode number 29, 32Coding 28Concentration table 71, 77Control solution 70stability 81Control window, test strips 43Cus

Pagina 34

129Alphabetical indexFFlagging, result 40HHealthcare professionals 3, 91Hi (display) 45, 50, 106Hourglass (symbol) 35, 102IInfection risk 91

Pagina 35

1413129101113Getting to know your meter9 Code chip slot10 Code chip (inserted)11 Type plate12 Battery compartment13 Battery (type CR 2032)14 Locking c

Pagina 36

130Alphabetical indexmg/dL (symbol) 102mmol/L (symbol) 102OOverviewmeter 12symbols 101PPatents 123PC (display) 66, 106Performance analysis

Pagina 37

131Alphabetical indexset-up (symbol) 22, 102Sources of electromagnetic interference 99Sources of interferenceelectromagnetic ~ 99light 98Stora

Pagina 38

132Alphabetical indexTurning onchanging settings 22downloading results 66retrieving results 54testing 31Type plate 13, 17UUnit of measuremen

Pagina 42

14Getting to know your meter1.2 The main features at a glanceFast testing The meter needs only approximately 5 seconds for each test. Easy testin

Pagina 43

15Getting to know your meter Data transfer The meter has an infrared port enabling you to download stored test results to a computer. Applying blo

Pagina 44

16Steps before testingSteps before testing2 2.1 Checking the contentsCheck that the contents of the package are complete. You will nd a list with th

Pagina 45

17Steps before testing2.2 Checking the unit of measurement for blood glucoseBlood glucose results can be displayed in two differ-ent units (mg/dL or

Pagina 46

18Steps before testing2.3 RemovingtheprotectivelmfromthebatteryThe meter is supplied with a battery inserted. The battery contacts are covered

Pagina 47

19Steps before testing2.4 Performing a display checkPress at the same time for more than 3 secondsYou can check if all of the display elements are p

Pagina 48

2Explanation of symbolsConsult the instructions for useCaution (refer to accompanying docu-ments). Please refer to safety-related notes in the manual

Pagina 49 - 5.6 Evaluating results

20Steps before testing2 Compare the display of your meter with the one shown here.If any of the display elements are missing or the unit shown for th

Pagina 50

21Setting the time and dateSetting the time and date3 The time and date is not preset in new meters. You can still, perform blood glucose tests. In th

Pagina 51

22Setting the time and datePress for more than 3 seconds3.1 OverviewTurning the meter onPress the S button and hold it down (for more than 3 seconds

Pagina 52

23Setting the time and dateTime and date formatTime (hour, minute)YearDate (month, day)Final displayPress briey at the same timeConrmingthechange

Pagina 53 - Using the meter as a diary6

24Setting the time and date3.2 Making settingsSetting the time and date format You can choose between two formats: 24-hour format 35 time from 0:00

Pagina 54 - Press briey

25Setting the time and dateSetting the time The hours ash in the upper left corner of the display.1 Press the M button to set the hours.2 Press the

Pagina 55

26Setting the time and dateSetting the year The year ashes in the upper right corner of the display.1 Press the M button to set the year.2 Press th

Pagina 56

27Setting the time and dateFinal displayThe day ashes in the display.3 Press the M button to set the day.4 Press the S button, and you will see the

Pagina 57 - Time and date not set

28CodingCoding4 A code chip is used to give the meter information about the properties of the test strips. This is why each pack of test strips contai

Pagina 58 - 6.3 Retrieving averages

29Coding1 Compare the code number on the chip with the corresponding code number on the label of the test strip container.The three-digit number on t

Pagina 59

3Intended useIntended useThe Accu‑Chek Active blood glucose meterMeter for quantitative determination of blood glucose values in fresh capillary blood

Pagina 60 - Press briey at the same

30Testing blood glucoseTesting blood glucose5 Please also consult the directions given at the end of this Chapter in the section “Notes on blood gluco

Pagina 61 - Order of the averages

31Testing blood glucose5.2 Testing blood glucoseTurning the meter on 1 Take a test strip from the container and close the container again immediatel

Pagina 62

32Testing blood glucosemg/dL meter mmol/L meterThe meter turns on and rst performs a default display check (approx. 2 seconds).4 Check that all the

Pagina 63

33Testing blood glucose5 Check that this code number is the same as the code number on the label of the test strip con-tainer.If the numbers do not m

Pagina 64 - 6.4 Downloading test results

34Testing blood glucoseApplying blood with the test strip in the meterWhen the test strip and the ashing blood drop symbols are displayed, you have a

Pagina 65

35Testing blood glucoseThe ashing hourglass symbol indicates that the test is in progress. The test is complete after approx. 5 seconds and the res

Pagina 66 - Press for more than 3

36Testing blood glucoseApplying blood with the test strip outside the meterWhen the test strip and the ashing blood drop symbols are displayed:1 Rem

Pagina 67

37Testing blood glucose2 Prick the side of a ngertip with your lancing device.3 Encourage a drop of blood to form by gently massaging your nger to

Pagina 68

38Testing blood glucoseThe test starts and the ashing hourglass symbol indicates that the test is in progress.The test is complete after approx. 10

Pagina 69

39Testing blood glucoseTurning the meter off1 Remove the test strip from the meter.The meter turns itself off.You can dispose of used test strips in

Pagina 70 - Checking your meter7

4About these Instructions for useAbout these Instructions for usePlease read these Instructions for use carefully and completely before testing blood

Pagina 71

40Testing blood glucoseFlagging test resultsYou can ag test results to describe certain events connected to the result or particular characteristics

Pagina 72

41Testing blood glucoseWhile the test result is displayed:1 Press the S button repeatedly until the desired ag is displayed.The ags appear in the f

Pagina 73

42Testing blood glucoseAfter choosing the desired ag, you can turn the meter off (see “Turning the meter off”), or go to the saved test results (s

Pagina 74

43Testing blood glucose5.3 Checking the test result using the test strip control windowThe test strip itself allows you to estimate the test result a

Pagina 75

44Testing blood glucoseAfter the testThe label on the test strip container shows blood glucose values in mg/dL und mmol/L next to each colour sample.1

Pagina 76 - Control (bottle)

45Testing blood glucose5.4 Symbols seen before, during or after testing and what they meanThe following symbols can appear on the disply before, duri

Pagina 77 - 2 134 – 181 7,4 – 10,0

46Testing blood glucose5.5 Notes on blood glucose testing Incorrect results can cause the wrong therapy recommendation to be made and so lead to ser

Pagina 78

47Testing blood glucose The test strips are sensitive to humidity and moisture. Only remove test strips from the con-tainer when your hands are comp

Pagina 79

48Testing blood glucose You can touch the test eld when you apply blood, but do not rub the drop of blood into the test eld. Do not store used tes

Pagina 80

49Testing blood glucosei Further information If you missed the code number in the display after you inserted the test strip, remove it from the met

Pagina 81

5About these Instructions for useIn these Instructions for use you will come across three kinds of notes. Please read these very care-fully. This sym

Pagina 82 - Cleaning the meter8

50Testing blood glucoseMeasuring rangeThe meter measures blood glucose results in the range from 10 to 600 mg/dL (0.6–33.3 mmol/L).If the result is lo

Pagina 83 - 8.1 External parts

51Testing blood glucoseImplausible results – possible sources of errorIf your meter repeatedly displays implausible results or error messages, please

Pagina 84

52Testing blood glucoseDid you bend the test strip while inserting it into the meter?noDid you wait for the drop symbol to ash in the display before

Pagina 85

53Using the meter as a diaryUsing the meter as a diary6 6.1 MemoryYour meter can save up to 350 test results with their time and date. You do not nee

Pagina 86

54Using the meter as a diary6.2 Retrieving results from the memory1 With the meter turned off, press the M button.You can also go directly to the sa

Pagina 87 - Changing the battery9

55Using the meter as a diaryRetrieving older results:2 Press the S button.While you press the S button, the memory location number is displayed. When

Pagina 88

56Using the meter as a diaryTurning the meter off again:3 Press the M button briey.You can directly switch from the saved results to the test by ins

Pagina 89 - + symbol facing upwards

57Using the meter as a diaryNo result in the memory Time and date not setIf there are no results saved in the meter, the display shown next to this te

Pagina 90

58Using the meter as a diary6.3 Retrieving averagesThe meter can calculate averages from the saved results. The averages are calculated for three gro

Pagina 91

59Using the meter as a diary1 With the meter turned off, press the M button briey.You can also briey press the M button directly after a test while

Pagina 92

6About these Instructions for useIn these Instructions for use you will see examples of display screens. Elements that are surrounded by a halo in the

Pagina 93 - 10.1 Testing blood glucose

60Using the meter as a diary2 Press the M and S buttons briey at the same time.You can not only call up the averages from within the last saved resu

Pagina 94

61Using the meter as a diaryTo go the next average:3 Press the M and S buttons briey at the same time.The averages are displayed in the order shown

Pagina 95 - 10.2 Disinfecting the meter

62Using the meter as a diaryGo back to saved resultsorturn the meter off.Press brieyPress brieyFrom within each average you can either go back to th

Pagina 96 - 11.1 Temperature

63Using the meter as a diaryIf there are no results saved for the selected average, three dashes are displayed.The meter calculates the average for a

Pagina 97

64Using the meter as a diary6.4 Downloading test resultsInfrared portYour meter has a built-in infrared port which enables wireless data downloading

Pagina 98 - 11.3 Light conditions

65Using the meter as a diaryDepending on which type of analysis you opt for, you will require either a special software programme and/or special hardw

Pagina 99 - 11.4 Sources of interference

66Using the meter as a diary1 Read the operating instructions supplied with the software and hardware you are using. There you will nd all the infor

Pagina 100

67Using the meter as a diary5–20 cm4 Place the meter approx. 5-20 cm away from the infrared port of the receiving end. Position the two infrared port

Pagina 101

68Using the meter as a diaryPress brieyIf the meter was not turned off automatically by the receiving end when the download was completed, is displa

Pagina 102

69Using the meter as a diaryIf downloading is unsuccessfulIf the results are not downloaded ( is still ashing in the display), the meter turns off a

Pagina 103

Contents1 Getting to know your meter 121.1 Your meter at a glance ...

Pagina 104

70Checking your meterChecking your meter7 You can check whether the meter provides correct results. To perform this performance check, a glucose contr

Pagina 105

71Checking your meter7.1 Preparing for a performance checkFor a performance check, you need: the meter with the code chip insertedthe Accu-Chek Act

Pagina 106

72Checking your meter7.2 Carrying out a performance check1 Read the package insert which came with the control solutions.2 Take a test strip from t

Pagina 107 - 12.2 Problems

73Checking your metermg/dL meter mmol/L meterThe meter turns on and rst performs a default display check (approx. 2 seconds).5 Check that all the se

Pagina 108

74Checking your meter6 Check that this code number is the same as the code number on the label of the test strip con-tainer.If the numbers do not mat

Pagina 109 - 12.3 Error messages

75Checking your meter7 Open a bottle of control solution.8 Wipe the tip of the dropper with a clean, dry paper towel to remove any dried-on residues

Pagina 110

76Checking your meterNo agPress 4 times brieyControl (bottle)The ashing hourglass symbol indicates that the test is in progress. The test is comp

Pagina 111

77Checking your meterFigures are examplesAfter agging the result as a performance check:12 Compare the test result with the concentration table on t

Pagina 112

78Checking your meter13 Then remove the test strip from the meter.The meter turns itself off.You can dispose of used test strips in your house-hold w

Pagina 113

79Checking your meter7.3 Possible sources of error during performance checksIf the result is outside the specied concentration range, repeat the per

Pagina 114

5 Testing blood glucose 305.1 Preparing to test blood glucose ...

Pagina 115

80Checking your meterDid you take the test strip from the container which the code chip in the meter belongs to?yesDid you perform the performance che

Pagina 116 - Technical data13

81Checking your meterDid you compare the test result with the concentration data that corresponds to the control solution you used?yesIs the concentra

Pagina 117

82Cleaning the meterCleaning the meter8 You may need to clean the meter if it becomes dirty through improper use. Healthcare professionals using the

Pagina 118

83Cleaning the meter8.1 External partsIf the case of the meter or the display is dirty:1 Wipe away any dirt using a cloth lightly mois-tened with co

Pagina 119

84Cleaning the meter1 Pull the cover of the measuring window straight towards you.2 Wipe the cover and the test strip guide from the outside and the

Pagina 120

85Cleaning the meter3 Carefully wipe the measuring window and its surrounding area using a lightly moistened cloth or a cotton swab. Make sure that

Pagina 121 - Disposing of your meter14

86Cleaning the meter6 Place the cover straight and centred onto the meter.7 Slide it closed until it audibly clicks into place.In doing so, the guid

Pagina 122 - System components15

87Changing the batteryChanging the battery9 When the battery symbol appears in the display for the rst time, the battery is almost empty. You can p

Pagina 123 - Patents16

88Changing the batteryThe battery compartment is located on the back of the meter.1 Push the locking catch downwards and remove the battery compartme

Pagina 124 - 17.2 Addresses

89Changing the battery3 Place the new battery in the compartment, with the + symbol facing upwards.4 Re-attach the battery compartment cover so the

Pagina 125

6 Using the meter as a diary 536.1 Memory ...

Pagina 126

90Changing the battery5 Press the cover closed. It will CLICK into place audibly. Never throw batteries into a re. They may explode.i Dispose of u

Pagina 127 - Alphabetical index18

91Testing blood glucose in more than one patient – Information for healthcare professionalsTesting blood glucose in more than one patient – Informatio

Pagina 128

92Testing blood glucose in more than one patient – Information for healthcare professionals Patients and medical staff are potentially at risk of bec

Pagina 129

93Testing blood glucose in more than one patient – Information for healthcare professionals10.1 Testing blood glucose1 Wear protective gloves.2 The

Pagina 130

94Testing blood glucose in more than one patient – Information for healthcare professionals9 Encourage a drop of blood to form by gently massaging th

Pagina 131

95Testing blood glucose in more than one patient – Information for healthcare professionals10.2 Disinfecting the meterThe following parts of the mete

Pagina 132

96Measurement and storage conditionsMeasurement and storage conditions11 So that the meter works reliably and you obtain accu-rate results, make sure

Pagina 133

97Measurement and storage conditions Tests cannot be performed at temperatures below +5 °C and above +45 °C. In this case the following appears in t

Pagina 134

98Measurement and storage conditions11.2 Atmospheric humidityOnly test blood glucose when atmospheric humidity is below 85 %.Keep the meter below 93

Pagina 135

99Measurement and storage conditions Avoid sudden changes in light conditions while testing. The ashlight of a camera, for exam-ple, can lead to inc

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