Accu-Chek 98/79/EC, Reference Manual

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Page 2: ...This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices ...

Page 3: ...weight portable meter provides accurate results in seconds When you dose the test strip the meter measures your blood glucose level and displays your result It s that simple Before using your Accu Chek Sensor Meter or Accu Chek Softclix Lancet Device for the first time please refer to the Quick Reference Guide included in this pack Should you require further information please study this user s ma...

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Page 5: ... 4 Turning the Beeper On or Off 4 Setting the Time Date and Year 6 Setting the Hypo Flag 8 Coding Calibrating Your Meter 9 Testing 11 Gathering Supplies 11 Performing a Test 11 Marking a Result with a Flag Asterisk 16 Understanding Your Test Results 17 Do s and Don ts 18 Proper Test Strip Appearance 19 Using Memory 20 Quality Control Checks 22 Performing a Quality Control Check 24 Understanding Co...

Page 6: ...ring Data 31 Quick Reference Display Guide 32 Memory Displays 34 Display Messages 36 Battery Displays 36 Quality Control Check Displays 37 Error Messages 39 Technical Data 42 Product Specifications 43 Product Safety Information 45 Warranty and Service Instructions 46 Supplies and Accessories 47 Index 48 Any Questions 51 iv ...

Page 7: ... blood glucose result messages and glucose results stored in memory ON OFF Button Press to turn meter ON or OFF Right and Left Buttons Used for meter setup and review of memory Serial Port Used to transfer data Test Strip Slot Insert test strip here ...

Page 8: ...t the Accu Chek Sensor Meter 446 731 Code Key For coding calibrating your meter New code key comes with every vial of test strips Battery Cover Remove cover to change battery Code Key Slot Insert code key here ...

Page 9: ...c level and receive a reminder whenever you obtain a blood sugar result below this level See page 8 for additional information The meter also has a flag or asterisk that you can save in the memory with your blood sugar result See page 16 for additional information on this feature The meter will also calculate 7 14 and 30 day averages You do not have to set the time and date for the meter to give y...

Page 10: ...Do not apply blood on the top of the test strip Before Applying Blood This window should be completely yellow After Applying Blood This window should be completely filled with the blood drop Note Any area of the strip can be touched and the glucose reading will not be affected Comfort Curve Touch drop of blood here to the edge of the strip ...

Page 11: ... battery power by automatically turning off after 90 seconds of non use or 5 seconds after taking a strip out of the meter following a test If the meter does automatically shut off all tests in memory are saved Note After changing the battery your meter will prompt you to verify the time and date immediately after the battery is inserted This occurs only if the time and date had been set previousl...

Page 12: ...and date are set correctly If time and date have not been set previously wait 5 seconds then turn meter ON The meter beeps if the beeper is turned on Battery Symbol on the Display When a battery symbol appears on the display your battery is weak and has only enough power to run a few more tests Although the meter will still provide accurate results you need to replace the battery as soon as possib...

Page 13: ...fter the battery is inserted if time and date had previously been set See Setting the Time Date and Year on page 6 Note To retain the correct time and date settings you will need to replace the battery before it is completely dead Please dispose of meter battery according to your local ordinances 3 Battery must be replaced to continue testing I I I I I I I I I I I I I I I I ...

Page 14: ...due to errors will still sound The meter is set to beep when A strip is inserted Blood or control solution is applied to strip A result is displayed An error occurs while testing Buttons are pushed Battery is installed If you do not want the beeper on turn it off by following these steps 1 Press and release the ON OFF button to turn the meter ON 2 Wait until the strip icon flashes or code and appe...

Page 15: ... is now on Note You may leave the set mode at any time by pressing and holding the ON OFF button The settings you have entered will be saved 4 Press and release the right or left arrow button OFF set and the beeper symbol appear on the display The beeper is now off To turn beeper back on simply press and release the right or left arrow button again 5 I I I I I I Sensor I I I I I I ...

Page 16: ...f you plan to review your memory to check when a test was done To set the time date and year 1 Press and release the ON OFF button to turn the meter ON 2 Wait until the strip icon flashes or code and appear before proceeding to step 3 3 Press and hold down the ON OFF button until set appears at the bottom of the screen Release the ON OFF button 4 Press and release the ON OFF button to confirm beep...

Page 17: ...t arrow button until the correct month is displayed 11 Press and release the ON OFF button The day display flashes 12 Press and release the right or left arrow button until the correct day is displayed 13 Press and release the ON OFF button The year display flashes 14 Press and release the right or left arrow button until the correct year is displayed 15 To leave this function press and hold down ...

Page 18: ...our healthcare professional To set the hypo flag 1 Press the ON OFF button to turn the meter on 2 Wait until the strip icon or code and flash before proceeding to step 3 3 Press and hold down the ON OFF button until set appears at the bottom of the screen Release the ON OFF button 4 Repeatedly press and release the ON OFF button until hypo flashes and OFF and set appear on the display Note the met...

Page 19: ...ps you need to set the meter to match the strips This is called coding calibrating To ensure accuracy of your blood glucose monitoring system you must change your code key with each new box of test strips Each code key provides your meter with the specific information that your meter needs to accurately measure your blood glucose Do not use code keys with your Accu Chek Sensor Meter from any test ...

Page 20: ...lays appear 1 Make sure meter is turned off Turn meter over so you are looking at the back Remove old code key if one is installed 2 Insert new code key until it snaps into place 3 Turn meter ON A 3 digit code number appears This number must match the code number on your vial of test strips If it does not repeat steps 1 3 10 Code 731 Sensor 545 731 I I I I I I I I I ...

Page 21: ...t Test Strips Accu Chek Softclix Lancet Accu Chek Softclix Lancing Device Performing a Test 1 Wash your hands in warm soapy water Rinse well and dry completely Warming fingers can increase blood flow 2 Load lancet device according to manufacturer s instructions To reduce the risk of infection change lancet with each test 11 ...

Page 22: ...est strip into test strip slot with silver coloured bars facing up and toward the meter The meter turns on automatically Check that the code number on the meter matches the code on the vial of test strips you are using When the blood drop symbol flashes you are ready to perform a test 12 I I I I I I I I I I Code 731 Sensor ...

Page 23: ...on your finger 8 Touch and hold drop of blood to the edge of the strip within the curve Do not place the blood drop on top of the strip The blood will be drawn into the strip automatically If beeper is turned on meter will beep to let you know the test is beginning Hold your finger to the edge of the strip until the yellow window is completely filled with blood What if I still see yellow on the te...

Page 24: ...lt is automatically recorded in the meter s memory You may also want to record the glucose value in your Record Book or Diary Note For instructions on how to store a result in memory with a general flag asterisk refer to Marking a Result with a Flag Asterisk on page 16 14 I I I I I I I I I I I I I I I I I I I TIM E RE SU LTS TIM E RE SU LTS TIM E RE SU LTS TIM E BLOOD TEST RESULTS or ...

Page 25: ...seconds after removing the strip If HI is displayed your blood glucose result may be higher than 600 mg dL 33 3 mmol L refer to your test strip package insert or the section Understanding Your Test Results on page 17 If LO is displayed your blood glucose result may be lower than 10 mg dL 0 6 mmol L refer to your test strip package insert or the section Understanding Your Test Results on page 17 15...

Page 26: ...iary An example includes using the asterisk to mark a result taken immediately after a meal To mark a result with a flag asterisk 1 Perform blood glucose test and obtain result 2 While the strip is still in the meter press and release the right or left arrow button An asterisk will appear on the lower right corner of the screen 3 Remove the strip from the meter turn the meter OFF or the meter will...

Page 27: ...fore the expiration date Were the test strips stored at extreme temperatures such as in the car during very cold or hot weather Were the test strips stored in areas of high humidity such as the kitchen or the bathroom Then run a quality control check with your glucose control solutions and a new test strip See page 22 Quality Control Checks If the control result is within the acceptable range revi...

Page 28: ...ore strips in the original vial DON T Store strips outside original vial Use expired test strips Use code key from another blood glucose system Store meter or strips in extreme temperatures Store meter in damp or humid areas Insert any object other than a test strip into strip slot Remove or insert code key while meter is on Test with meter placed on hot or cold surfaces 18 ...

Page 29: ...on page 39 Repeat the test 19 I I I I I I I I I I I I I I I I I I I Notice that the left side of the yellow window is not completely filled with blood This strip has too little blood and may produce an error message or an inaccurate result This strip has the correct amount of blood If this display remains after the blood drop is applied then your drop was too small Reapply a larger drop of blood T...

Page 30: ...ore it is completely dead The Accu Chek Sensor Meter also calculates 7 14 and 30 day averages You do not have to set the time and date for the meter to give you average calculations HI or LO results results outside of the meter s reading range and results marked as a control are not included in averages If a HI or LO result is detected in memory 7 day ave 14 day ave or 30 day ave flashes on the di...

Page 31: ... arrow button again to enter memory recall mode 2 Once in the memory mode Press the left arrow button to view individual results in memory Or Press the right arrow button to review in sequence 7 14 and 30 day averages Note Press and hold down the right or left arrow button to quickly scroll through results 3 Turn meter OFF 21 or or ...

Page 32: ...f you leave the cap off the vial of test strips Before using your meter for the first time When you open a new vial of test strips If you drop the meter Whenever your result does not agree with the way you feel If you have repeated a test and the blood glucose result is still lower or higher than expected When you want to check the performance of the meter and test strip 22 ...

Page 33: ... bottle of glucose control solution write the date on the label Opened bottles of glucose control solution are good for three months or until the expiration date whichever comes first Important Make sure you use the proper control solution for the test strips you have Accu Chek Sensor Comfort Test Strips require Accu Chek Sensor Comfort Glucose Control Solutions 23 DATE ...

Page 34: ...e code on the vial of test strips you are using The test strip symbol stops flashing and a blood drop symbol appears on the display 3 Press and release the right arrow button once to select a L1 Level 1 control or twice to select a L2 Level 2 control Note Results marked as L1 or L2 do not appear in memory or averages 4 Hold the control bottle horizontally with the tip pointed directly at the right...

Page 35: ...ay until the measurement is complete 7 Tightly replace the cap on control solution 8 The control result appears If result is within the acceptable range which is found on the side of the vial of strips an icon of the control vial appears on the screen while the control test result and time and date if set alternate with OK and L1 or L2 on the display Example of an acceptable Level 1 control result...

Page 36: ...the screen while the control test result and time and date if set alternate with Err and L1 or L2 on the display See Understanding Control Results on page 27 for more information Example of an unacceptable Level 1 control result or 9 Remove test strip from meter and discard Note Marking a test as L1 or L2 prevents the quality control result from taking up space in the meter s mem ory If you do not...

Page 37: ... use control solutions or test strips that were past their expiration date Did you leave the cap off the vial of test strips or glucose control solutions Did the code in the meter match the code on the test strip vial label Did you follow the testing steps exactly Did you use the proper glucose control solution for the test strips you used Did you select the appropriate control result level L1 or ...

Page 38: ...e of the meter as needed using a soft cloth that has been slightly dampened with one of the following 70 alcohol a solution of mild dishwashing liquid and water 10 household bleach solution 1 part bleach in 9 parts water made fresh daily Sekupoudre Super Sani wipes Ammonium Chloride with alcohol Do not get moisture into the code key slot test strip slot or the serial port Note to Healthcare Profes...

Page 39: ...mperature and humidity and handle it with care If meter is dropped perform a quality control check with the glucose control solutions before doing a blood glucose test The travel case is designed to let you store a variety of supplies you may need and helps to protect your meter 29 ...

Page 40: ...e blood is drawn Caution should be exercised in the interpretation of neonate blood glucose values below 50 mg dL 2 8 mmol L Blood glucose determination with venous or arterial blood must be performed within 30 minutes of sample collection Iced arterial blood specimens must be tested at room temperature Avoid air bubbles with the use of pipettes Fresh venous blood specimens containing the anticoag...

Page 41: ...fferent ways Directly to your computer using a specialized software and interface cable Via specialized modems designed for remote transfer Consider the following when using accessory equipment DO NOT run a glucose test when the Accu Chek Sensor Meter is connected to accessory equipment For more information please contact your doctor or healthcare professional and your local distributor 31 ...

Page 42: ... turn meter OFF and insert code key see page 9 Meter is in the set function allowing you to set the beeper time date year and hypo flag see page 4 Meter is ready to accept a test strip Blood drop can be applied to test strip see page 12 32 I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I ...

Page 43: ... Repeat test If HI still appears follow your doctor s instructions Blood glucose result may be lower than 10 mg dL 0 6 mmol L If this does not confirm the way you feel review proper testing procedure and perform a quality control check page 22 Repeat test If LO still appears follow your doctor s instructions Blood glucose result is lower than hypo flag level set on meter see page 8 33 I I I I I I ...

Page 44: ...The result you have obtained may not be accurate Move to an area between 14 and 40 C wait 5 minutes and repeat the test Do not artificially heat or cool the meter Memory Displays The meter is in the memory function allowing you to recall results from memory see page 20 34 or or ...

Page 45: ...test was performed outside the operating range of the test strips 14 to 40 C The meter is in the memory function allowing you to recall 7 14 and 30 day averages This blood glucose result was marked with a result marker flag asterisk see page 16 Do not use individual values stored in memory to make therapy adjustments 35 or or or ...

Page 46: ...s Battery Displays Battery power is low Change battery soon battery symbol not flashing Battery is dead Change battery now Meter will turn off after 3 seconds flashing battery symbol 36 I I I I I I I I I I I I I I I I ...

Page 47: ...Quality Control Check Displays Meter is ready for a Level 1 or Level 2 glucose control check Apply a drop of Level 1 or Level 2 glucose control solution 37 I I I I I I I I I I and I I I I I I I I I I ...

Page 48: ...ple of an acceptable control result or Glucose control result is not acceptable Repeat test Refer to Understanding Control Results see page 27 Example of an unacceptable control result or 38 and and and and ...

Page 49: ...ey If this error display still appears contact Roche Diagnostics Your blood sugar may be extremely low an incorrect amount of blood was applied or the test strip is damaged or inserted improperly If you see this error message after you put blood on the test strip refer to the section in the manual titled Understanding Your Test Results see page 17 If you see this error message before you put blood...

Page 50: ...a quality control check with your glucose control solutions and a new test strip If the control result is within the acceptable range review the proper testing procedure and repeat your blood glucose test with a new test strip If mg dL error or mmol L error still appears for your blood glucose test your blood glucose result may be extremely high or low and above or below the system s reading range...

Page 51: ...y future test results Temperature is above or below the operating range of the meter Move to an area between 14 and 40 C wait 5 minutes and perform a test Do not artificially heat or cool the meter Meter has failed its series of electronic checks Turn meter OFF then ON again If this error display still appears testing cannot take place Call Roche Diagnostics 41 I I I I I I I I I I I I I I I I I I ...

Page 52: ...he mediator hexacyanoferrate III forming the reduced form of the mediator hexacyanoferrate II The test strip employs the electromechanical principle of biamperom etry The monitor applies a voltage between two identical electrodes which causes the reduced mediator formed during the incubation period to be reconverted to an oxidized mediator This generates a small current that is read by the monitor...

Page 53: ...r more information Memory Capacity 480 blood glucose results with time and date Display LCD display Blood Volume Refer to your test strip package insert for more information Size 3 3 x 2 2 x 8 84 mm x 56 mm x 20 mm Weight 1 8 oz 57 g Accuracy Refer to your test strip package insert for more information Precision Refer to your test strip package insert for more information Sample Types Capillary ve...

Page 54: ...32 DL 2032 or equivalent Data Port 3 wire RS 232C Serial Port Multiplexed TTL UART Test Strip Refer to your test strip package Storage Conditions insert for more information Construction Hand held Protection Class III Rated Operation Continuous operation 44 ...

Page 55: ...10 1 This product fulfills the requirements of Directive 98 79 EC on in vitro diagnostic medical devices For in vitro diagnostic use Manufactured by This meter is suitable for continuous operation Meter is not protected against ingress of water Meter is not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide 45 Laboratory Use Electrical Equipment 8C79 ...

Page 56: ...en misused or tampered with Roche undertakes to repair faulty components free of charge or at their discretion to provide a fault free replacement meter Be sure to fill out the warranty form that came with your system and return to Roche Diagnostics Statutory and other rights This manufacturer s warranty is in addition to any statutory or other rights which may be acquired by the customer through ...

Page 57: ... supplies and accessories are available from pharmacies or your local surgical supplier Accu Chek Sensor Comfort Test Strips Accu Chek Sensor Comfort Glucose Control Solutions Accu Chek Softclix Lancets Accu Chek Softclix Lancing Device 47 ...

Page 58: ...ttery cover vi 1 Battery installation 1 Beeper turning on or off 4 Blood sample 11 Caring for your meter 28 Cleaning 28 Checking the system 22 24 27 28 39 Checking the display 28 Code key vi 9 Code key slot vi Coding calibrating your meter 9 Control results 27 37 Control solutions 22 Display messages 36 Display check 28 Do s and don ts 18 48 ...

Page 59: ...2 HI display 15 33 Hypo flag 8 Inserting strip 12 Level 1 glucose control solution 24 Level 2 glucose control solution 24 LO display 15 33 Marking a result with a flag asterisk 16 Memory 20 ON OFF button v Quality control checks 22 37 Quick reference display guide 32 Recalling stored values 20 Right and left buttons v 49 ...

Page 60: ...d handling 29 Supplies and accessories 47 Testing blood glucose 11 Testing quality control 22 27 Test strip slot v Test strip vial 10 12 Time date and year setting 6 Transferring data 31 Troubleshooting 17 22 27 39 Understanding control results 27 Warranty 46 50 ...

Page 61: ...RE USE GUARANTEE The statutory guarantee provisions governing the sale of consumer goods in the country of purchase shall prevail This product may be covered by one or more of the following patents U S Patent Nos 4 999 632 4 999 582 4 963 814 5 508 171 5 352 351 5 405 511 5 438 271 5 627 075 5 288 636 4 891 319 5 053 199 5 366 609 5 508 171 5 997 817 6 254 736 6 270 637 4 924 879 Re 35 803 and Re ...

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Page 63: ...ACCU CHEK and SOFTCLIX are trademarks of a Member of the Roche Group 03654117001 0703 2003 06 Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim Germany www roche com ...