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1

On packaging, on the type plate of the meter, on the lancing device itself
and in these instructions for use you may encounter the following sym-
bols, shown here with their meaning:

Please consult instructions for use

Catalogue number

IVD

For in vitro diagnostic use

Store at

Use by/Expiry date

Lot number

0088

Blood glucose meter and test strips: These products fulfil

the requirements of Directive 98/79/EC

on in vitro diagnostic medical devices.

Lancing device and lancets: These products fulfil the
requirements of Directive 93/42/EEC on medical devices.

0088

AST cap: This product fulfils the requirements of Directive
93/42/EEC on medical devices.

Manufacturer

Caution (refer to accompanying documents). Please refer to
the safety-related notes in the manual accompanying this
instrument.

For single use only

Sterilized using irradiation

Last update user information: November 2004

This booklet consists of four parts.

Part 1

Instructions for use (User’s Manual) for the Accu-Chek Integra blood
glucose meter.

Part 2

Instructions for use for the Accu-Chek Softclix lancing device.

Part 3

Instructions for use for the Accu-Chek Softclix AST cap, used to collect
blood from alternative sites (accessory for the Accu-Chek Softclix
lancing device).

Part 4

Appendix

Please read the instructions in this booklet carefully and completely be-
fore performing the first measurement. Should you have any questions,
call the Accu-Chek Enquiry Line on 1800 251 816.

Please read with special attention all text in this booklet that is preceded
by the following symbols:

This symbol signifies a possible risk of injury or of damage to

your health.

This symbol indicates that your meter or lancing device is at

risk of being damaged.

i

This symbol highlights important information.

Farbe: PMS 583 – Prüfmittelnummer: 208

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Содержание Integra

Страница 1: ...583 Prüfmittelnummer 208 ACCU CHEK Integra ACCU CHEK ACCU CHEK INTEGRA and SOFTCLIX are trademarks of Roche Roche Diagnostics Australia Pty Ltd 31 Victoria Avenue Castle Hill NSW 2154 Accu Chek Enquiry Line 1800 251 816 www accu chek com Roche Diagnostics GmbH D 68298 Mannheim Germany www accu chek com ...

Страница 2: ...ingle use only Sterilized using irradiation Last update user information November 2004 This booklet consists of four parts Part 1 Instructions for use User s Manual for the Accu Chek Integra blood glucose meter Part 2 Instructions for use for the Accu Chek Softclix lancing device Part 3 Instructions for use for the Accu Chek Softclix AST cap used to collect blood from alternative sites accessory f...

Страница 3: ...nd Tissue Approved Guideline NCCLS document M29 A 1997 Contents Part 1 Accu Chek Integra Blood Glucose Meter User s Manual 1 Introduction 10 1 1 Your blood glucose meter at a glance 10 1 2 Main features 14 1 3 About this manual 16 2 Initial steps before testing 18 2 1 Checking the contents 18 2 2 Checking that the correct unit is displayed 19 2 3 Inserting or replacing the batteries 20 2 4 Perform...

Страница 4: ...er 71 8 Measurement and storage conditions 75 8 1 Temperature range 75 8 2 Atmospheric humidity 77 8 3 Sources of interferences 77 9 Display messages and troubleshooting 78 9 1 Messages and symbols 79 9 2 Troubleshooting 84 10 Technical data 95 Contents Part 2 Accu Chek Softclix Lancing Device Instructions for Use 11 Introduction 100 11 1 Your lancing device at a glance 100 11 2 About the Accu Che...

Страница 5: ...ation for users 113 14 AST testing 116 14 1 Preparing for AST testing 116 14 2 Measuring blood glucose 119 15 Cleaning the Accu Chek Softclix lancing device and the AST Cap 120 Contents Part 4 Appendix 16 System components 122 17 Guarantee 123 18 Patents 123 19 Local customer support and service 124 19 1 Information and repair 124 19 2 Contact us 125 20 Alphabetical index 126 ...

Страница 6: ...8 Farbe PMS 583 Prüfmittelnummer 208 Part 1 ACCU CHEK Integra BLOOD GLUCOSE METER User s Manual ...

Страница 7: ...y window ON OFF button Press this button only if you want to test your blood glucose or to turn the meter off Drum compartment release button Drum compartment Test strip drum Test strip Optical system Optical system cover MEMO button Press this button to view results stored in the meter s memory Display cover available as replacement part Front edge of strip that draws up blood ...

Страница 8: ... Your blood glucose meter at a glance Battery compartment cover Type plate Infrared window Battery compartment Batteries Type AAA LR 03 AM 4 Micro Test strip guide Control window shows the number of strips remaining available as replacement part ...

Страница 9: ...a blood glucose meter checks each test strip If it finds a defective strip it lets you know before you apply blood Blood volume checking The Accu Chek Integra blood glucose meter can tell when you have applied sufficient blood approximately 1 5 µL 1 microlitre 1 thou sandth of a millilitre It waits until then before starting the measure ment If the measurement does not start you may apply more blo...

Страница 10: ... L You have turned on the meter to perform a blood glucose measurement The display shows a number of elements some of which the blood drop and the hand symbol are flashing The date time and blood glucose results shown in the display are in tended only as examples They will not be the same as those shown by your Accu Chek Integra meter The blood glucose meter that is depicted displays blood glucose...

Страница 11: ...ucose results can be displayed in two different units mmol L or mg dL Consequently Roche sells two different versions of the same meter Check that your meter displays the unit you are accustomed to On the back of your meter you will find the unit for which your instru ment is coded Ask your doctor if you do not know which is the right unit for you The setting cannot be changed If the wrong unit is...

Страница 12: ...ff Press lightly on the lid of the battery compartment and slide it in the direction of the arrow 1 Open the battery compartment 2 Remove any used batteries Insert two batteries type AAA LR 03 AM 4 or Micro Make sure that the minus pole of the battery is next to the minus contact in the battery compartment ...

Страница 13: ...glucose tests i Do not use rechargeable batteries They do not provide suffi cient voltage and will only allow you to perform a few measure ments before they need recharging i When the battery symbol appears in the display for the first time it indicates that the battery is running low You can per form about a further 50 tests We recommend however that you replace the batteries as soon as possible ...

Страница 14: ... if your Accu Chek Integra meter is to remain unused for some time i Think of the environment Dispose of used batteries sensibly 2 4 Performing a full display test To check that all of the display elements are functioning correctly you should carry out a full display test If the meter is on turn it off Press and hold down the MEMO button The meter turns on On appears briefly in the display While y...

Страница 15: ...results saved in memory when you release the MEMO button the most recently saved result is displayed Press the ON OFF button to turn the meter off i The meter automatically turns off if you keep the MEMO button pressed for more than 90 seconds 2 5 Inserting or replacing the test strip drum Read the package insert that came with the test strip drums If the meter is on turn it off Wait for the motor...

Страница 16: ...est strip drum Slide the release button on the right side of the meter in the direction indicated by the arrow The drum compartment opens To exchange the drum first tip the meter upright The old drum drops out i You can dispose of used drums with your regular household waste ...

Страница 17: ...rse side of the meter This dot indicates that you have just inserted a drum When you perform a blood glucose test the meter counts the number of test strips that have been used and displays the number of strips remaining Use only test strips that are within the expiry date Expired test strips can produce incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and s...

Страница 18: ...es given on the peel off label attached to the test strip drum container see Chapter 6 Checking the Accu Chek Integra meter You may for instance wish to stick the peel off label in your notebook or diary When conducting quality con trols always check that the peel off label with the concentration table belongs to the test strips that are currently in the meter i Use only Accu Chek Integra test str...

Страница 19: ...m the meter and then insert it again change the batteries and leave a partly used drum in the meter The meter has no way of telling when the drum was first inserted or how long the partly used drum has already been in the meter The drum symbol and CTRL flash in the display You are asked to perform a quality control test in order to check the test strips Carry out a quality control check see Chapte...

Страница 20: ...ively The procedure for changing the settings is as follows Press the SET button to call up the SET menu The field currently flashing in the menu may now be changed Press the MEMO button to change the current setting Numerals such as the year time and date can be incremented to a certain value then the count up starts again from the beginning In the case of settings where you have two options e g ...

Страница 21: ...it displays a message Check the meter is off Press the SET button The meter turns on without advancing a test strip from the drum The symbol for the beep tone flashes in the display window and ON appears Press the MEMO button to turn off the beep tone OFF appears in the display If you press the MEMO button again ON reappears If you wish to set the year leave the meter turned on and proceed to the ...

Страница 22: ...ght of the display The default value is 2000 Press the MEMO button repeatedly to set the year The meter scrolls upwards through the year values If you hold the MEMO button down the meter fast scrolls forward to 2032 and then begins again at 2000 If you wish to define the time and date format leave the meter turned on and proceed to the next section 3 3 If not press the ON OFF button to turn the me...

Страница 23: ...time is set to 00 00 Press the MEMO button to select 12 hour format In the display you see 12h and the time is set to 12 00 a m If you press the MEMO button again 24 h reappears If you wish to set the time leave the meter turned on and proceed to the next section 3 4 If not press the ON OFF button to turn the meter off The current settings will be saved automatically i If you do not set the time a...

Страница 24: ...d the MEMO button down the meter fast scrolls forward to 12 p m and then to 12 a m Press the SET button again The minute field flashes Press the MEMO button repeatedly to set the minute If you hold the MEMO button down the meter fast scrolls forward to 59 and then begins again at 0 If you wish to set the date leave the meter turned on and proceed to the next section 3 5 If not press the ON OFF but...

Страница 25: ...MO button repeatedly to select the correct month If you hold the MEMO button down the meter fast scrolls forward to 12 and then begins again at 1 Press the SET button again The day field flashes 24 hour format DD MM 12 hour format MM DD Press the MEMO button repeatedly to select the correct day If you hold the MEMO button down the meter fast scrolls forward to 31 and then begins again at 1 Press t...

Страница 26: ...and Infectious Disease Transmitted by Blood Body Fluids and Tissue Approved Guideline NCCLS document M29 A 1997 Keep the test strip away from skin unless you are touching it against blood Residues e g of skin cream food or drink on the skin can find their way onto the strip and may produce incor rect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce adve...

Страница 27: ...ing device i For testing with blood collected from alternative sites such as the forearm or the base of the thumb please turn to Part 3 and read the instructions for using the Accu Chek Softclix AST Accessory Wait until the flashing hand and blood drop symbol appear in the display and the meter beeps provided the beep tone is turned on You now have approximately 5 minutes in which to apply blood A...

Страница 28: ...ood You can then apply more blood see the package insert that came with the test strip drum As measurement progresses the three 000 disappear in turn from the display On completion of the test the result appears in the display together with the flashing test strip symbol The meter will save the result simultaneously 4 Testing blood glucose Touch the blood drop against the front edge of the test st...

Страница 29: ... ejected and the meter automatically turns off again i Always let the meter eject the test strip Never pull the test strip from the meter while the test is running Measurement is then interrupted and the following message is displayed Once a test strip has been ejected never push it back into the test strip chamber This could damage the meter If a test strip is pushed back into the test strip cham...

Страница 30: ...ty of a test result please check the following points Did you perform the test as directed see Chapter 4 Testing blood glucose Did you wait for the flashing hand symbol and blood drop symbol to appear before applying blood Did you wash your hands with warm water and soap to improve the blood flow and to remove any residues e g of food drink or skin cream Did you dry your hands well Did you just ge...

Страница 31: ...rmitted range are displayed together with a ther mometer symbol Please refer to Chapter 9 Display messages and troubleshooting for a complete list of display messages and symbols 5 2 Viewing test results With the meter turned off press the MEMO button The meter turns on without advancing a test strip from the drum The most recent test result and MEMO are displayed i Only turn on the meter with the...

Страница 32: ... meter turns on without advancing a test strip from the drum The most recent test result and MEMO are displayed Press the SET and MEMO buttons at the same time The average of your current test results is dis played identified by an A i When the average is being calculated all results flagged as control readings are ignored Press the MEMO button again The highest measured test result is displayed t...

Страница 33: ...ble you and your doctor to manage your data more effectively and through graph and table views make it easier for you to understand your self testing data Not all software programs are available in all countries For further infor mation please contact your local customer support and service centre i Data can only be evaluated on a PC or handheld computer as long as you have set the time and date s...

Страница 34: ...o flash and the meter turns off automatically after 5 minutes Please refer to Chapter 9 Display messages and troubleshooting 6 Checking the Accu Chek Integra meter 6 1 Quality control checking with Accu Chek Integra control solution To ensure your results are always dependable you must periodically check the performance of your Accu Chek Integra meter Do this by running a quality control check usi...

Страница 35: ...TRL will appear together with these in the display i If you pressed the SET button inadvertently you can press it again in order to remove the control test flag i If CTRL flashes in the display because the meter asked you to run a quality control check e g because you inserted a partially used test strip drum and you press the SET button CTRL stops flashing You now have approximately 5 minutes in ...

Страница 36: ...r with CTRL Refer to the table of expected values on the peel off label of the test strip drum container If the result is outside this range run another quality control check If the result of the second test is outside the expected range as well please check the following points Did you perform the quality control check as directed Did you perform the test within the correct temperature range 10 C...

Страница 37: ...s components being clean Owing to the way the test strip works the meter does not normally come into direct contact with blood or control solution Regular cleaning is therefore largely un necessary In the rare event of it becoming soiled through improper use cleaning may become necessary see error message OFF on page 92 For cleaning use only cold water Any other cleaning agents may damage the mete...

Страница 38: ...come visibly soiled the message OFF is displayed see page 92 Remove the cover from the measurement optics by slightly squeez ing it from both sides 1 and lifting it off 2 Clean the small window covering the optical system its surround ings and the test strip guide carefully with a lightly moistened cot ton swab or a soft lint free cloth ...

Страница 39: ...nsing solution wipe these fluids off immediately after application Do not use cleaning agents that contain acetic acid vinegar or scouring agents because they can damage the display and the measure ment optics 8 Measurement and storage conditions When testing blood glucose pay close attention to the following points They affect the dependability of your Accu Chek Integra meter and the accuracy of ...

Страница 40: ... or cooling of your Accu Chek Integra meter artificially e g by placing it on a radiator or in a refrigerator Doing so can damage your meter and cause it to give incorrect results Incorrect results can cause the wrong therapeutic decision to be taken and so produce adverse health effects 8 2 Atmospheric humidity Keep the meter at below 85 relative humidity Sudden changes in temperature cause conde...

Страница 41: ...risk of misinterpreting your blood glucose results Please note Several messages may be displayed simultaneously For example in this display the blood glucose result and time are not flashing while date test strip symbol thermometer symbol drum symbol and CTRL are flashing This means that the temperature during testing was at the limits of the permitted range the 90 day use by period for the test s...

Страница 42: ...message symbol appears and means CTRL You are requested to run a quality control test CTRL This is was a quality control test The temperature during testing is at the limits of the permitted range between 5 C and 10 C or between 40 C and 45 C Do not use the result as a basis for therapeutic decisions Turn the meter off Let the meter slowly cool down or warm up Turn the meter on and repeat the test...

Страница 43: ...result agrees with the way you feel follow your doctor s advice If the way you feel does not agree with this test result please per form a quality control check with the Accu Chek Integra Control solution and a new test strip Repeat the blood glucose test If you feel the new result is also implausible please contact your doctor This message symbol appears and means The blood glucose result is abov...

Страница 44: ...message symbol appears and means The test strip drum in the meter is empty Insert a new drum If the message is still dis played please contact Customer Support see Chapter 19 for details CTRL You inserted a test strip drum that has al ready been used You opened the drum compartment You changed the batteries without changing the test strip drum at the same time You are requested to run a quality co...

Страница 45: ... display until a new drum is inserted This message symbol appears and means There is no test strip drum in the meter Turn the meter off Insert a test strip drum You inserted a test strip drum from a differ ent blood glucose monitoring system Turn the meter off Insert an Accu Chek Integra test strip drum The bar code on the drum is damaged Turn the meter off If you inserted the first drum from a pa...

Страница 46: ...s by comparing their lot codes The lot code is printed on the label of the test strip drum next to the symbol This message symbol appears and means If the message is still displayed please contact Customer Support for details see Chapter 19 CTRL The 90 day use by period has been exceeded The test strips in the drum are unusable Insert a new drum If you continue to use the drum carry out a quality ...

Страница 47: ...d properly Ensure that the optical system cover is firmly in place This message symbol appears and means The test strip is stuck in the guide Turn the meter off Pull the strip out of the meter Open the drum compartment and remove the drum Reinsert the drum and close the drum compartment The drum symbol and CTRL flash in the display when the meter is turned on Perform a quality control check You ca...

Страница 48: ...the strip manually even if it takes a small amount of force You forcibly removed the test strip during testing Turn the meter off and on again Repeat the test with a new strip this time ejecting it by means of the ON OFF button This message symbol appears and means The test strip that has been advanced is defective Hold the meter with the strip pointing down wards Turn the meter off and let the st...

Страница 49: ... details 10 Technical data Meter type Accu Chek Integra Catalogue number serial number See type plate on the back of the meter Test principle Determination of glucose in fresh capillary blood by reflectance pho tometry When using different speci men material please refer to the package insert that came with the Accu Chek Integra test strip drums Measuring range 0 6 33 3 mmol L 10 600 mg dL Sample ...

Страница 50: ...g netic immunity requirements as per ISO 15197 Annex A The chosen basis for the immunity tests was basic standard IEC 61000 4 2 In addition it meets the electromag netic emissions requirements as per EN 61326 Its electromagnetic emission is thus low Interference from other electrically driven equip ment is not to be anticipated Blood glucose concentrations may be measured in whole blood or plasma ...

Страница 51: ...98 Farbe PMS 583 Prüfmittelnummer 208 Part 2 ACCU CHEK Softclix Lancing Device Instructions for Use ...

Страница 52: ...our lancing device at a glance A Cap B Comfort Dial for depth selection C Notch D Protective cap E Lancet F Lancet holder G Semi circular cut out H Ejector I Transparent release button J Priming button t u r n ed through 1 8 0 A B C D E H I J G F A CCU C HEK Softclix ...

Страница 53: ... The Accu Chek Softclix lancing device is an easy to use lancing device that has been specially developed to allow virtually pain free collection of capillary blood from a fingertip or earlobe The depth of lancet penetration can be precisely adjusted to suit indi vidual skin requirements Use the Accu Chek Softclix lancing device only with Accu Chek Softclix lancets as using any other lancet may pr...

Страница 54: ...from a fingertip or an earlobe We recommend using the side of a fingertip as this registers least pain Wash hands with warm water and soap and dry well This helps ensure proper hygiene and stimulates blood flow Selecting penetration depth with the Comfort Dial Modern blood glucose meters can take readings using just a tiny drop of blood Usually enough blood can be obtained with a low depth setting...

Страница 55: ...in with progressively deeper settings Perform a blood glucose test as described in Chapter 4 Testing blood glucose Do not prime the Accu Chek Softclix lancing device until you are ready to take blood Never expose the Accu Chek Softclix lancing device to extreme temperatures e g in a hot car Subsequent treatment of the puncture site Wipe the puncture site with a dry clean paper towel and keep it cl...

Страница 56: ...108 Farbe PMS 583 Prüfmittelnummer 208 Part 3 ACCU CHEK Softclix AST ACCESSORY Clear plastic AST cap for blood glucose determination with Accu Chek Integra on alternative sites Instructions for Use ...

Страница 57: ...tions so that you can decide which option is right for you Please consult your physician before using alternative sites for blood glucose testing Use the AST cap exclusively for collecting blood from alternative sites If you use this cap to collect blood from a fingertip the lancet penetrates too deep into the finger Pricking the skin is then very painful and can result in injury Please also follo...

Страница 58: ...e sites may therefore differ from values measured in blood from the fingertip This is because the fingertips contain more blood vessels than other sites Because of the possibility of discrepant blood glucose readings alterna tive site testing is not recommended up to two hours following a meal when blood glucose values are rising quickly after exercise if you have a temperature or if a medical con...

Страница 59: ... glucose result does not match how you feel you should do a fingertip test to check the result If the fingertip result still does not match how you feel contact your doctor Do not change your treatment decisions based on just one AST result i The success of collecting a suitably sized drop of blood from alternative sites may differ from person to person and from alternative site to alternative sit...

Страница 60: ...e device and press until it clicks Set the penetration depth to the highest setting 5 5 For AST on the base of the thumb a setting of 3 4 is often sufficient To obtain a sufficiently large drop of blood from alternative sites lancing must be deeper than on the finger However these sites are usually less sensitive to pain and most patients don t feel any pain at all Do not use the clear cap for sam...

Страница 61: ...s smaller release the pres sure for a few seconds keeping the de vice on the skin Then re apply pressure until you get a sufficiently large drop of blood 14 2 Measuring blood glucose 1 Obtain a drop of blood as described above 2 Hold the meter so the test strip is pointing downwards at a slight angle Touch the front edge of the test strip against the blood without delay The strip draws up the bloo...

Страница 62: ... AST cap using a cotton bud moistened with 70 alcohol Allow the lancing device and the two caps to dry thoroughly before per forming a new test Notes Do not prime the device until you are ready to take blood Carefully dispose of used lancets to avoid injuries Never expose the Accu Chek Softclix lancing device to extreme temperatures e g in a hot car Never dip the Accu Chek Softclix lancing device ...

Страница 63: ... lancets REF 0 3307492001 100 Accu Chek Softclix lancets REF 0 3307506001 200 Accu Chek Softclix lancets REF 0 3307484001 N B Not all pack sizes may be available in all countries To order a new AST cap please contact your nearest Roche Diagnostics office 17 Guarantee The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail 18 Patents Accu Che...

Страница 64: ...r for details Repair service Please note that any repair adjustment or other change of the meter or lancing device must only be performed properly by persons who have been authorized by Roche Diagnostics If you suspect that the meter or lancing device have a fault please start by contacting your Roche Diagnostics customer support representative Our staff will attempt to identify and solve your pro...

Страница 65: ...116 ff Too little applied 53 Volume 15 95 Blood drop symbol 50 f 66 79 C Checking the meter 65 ff Cleaning Meter 71 ff Lancing device 107 AST cap 120 Cleaning solution 71 74 107 120 Coding test strip drum 14 30 Computer downloading results to a 62 ff Control solution 65 ff 122 Control window test strip drum 12 31 35 Customer support 124 f CTRL symbol 65 f 68 81 D Date setting the date 46 f Display...

Страница 66: ...mplausible results 57 Infrared cable 62 f 94 Infrared window 12 15 62 f 93 f 96 20 Alphabetical index L Lancet 100 103 f 106 122 Lancing device 100 ff 122 Lot code 88 Lowest result 60 f M Measurement conditions 75 ff Measuring principle 95 Measuring time 95 Measuring range 56 95 MEMO button 10 MEMO symbol 80 f Memory 58 ff Meter Checking the meter 65 ff Cleaning the meter 71 ff Description of 10 f...

Страница 67: ...ts downloading to a computer 62 ff Results viewing stored results 59 20 Alphabetical index S Sample size 15 95 Service 124 f SET button 10 SET menu 36 ff Settings Beep tone 36 38 f Date 36 46 f Time 36 44 f Time date format 36 42 f Year 36 40 f Power off time 26 51 55 64 67 96 Power off automatic 96 Software 62 Storage conditions 75 ff Symbols explained 78 ff Symbols Battery 23 82 Beep tone 79 CTR...

Страница 68: ... 54 f Guide 12 Symbol 79 Testing blood glucose 48 ff Testing conditions 75 ff 95 Thermometer symbol 81 Time setting the time 44 f Time date format setting the format 42 f Troubleshooting guide 84 ff Type plate 12 f U Units mmol L and mg dL 19 25 79 Use by date test strip drum 34 f 55 89 V Values highest lowest average 60 f Y Year setting the year 40 f ...

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