Accu-Chek Performa Connect, Operator'S Manual

Page 1: ...Performa BLOOD GLUCOSE METER Operator s Manual...

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Page 3: ...Inform II Test Strips provides a complete test system that is meant for in vitro diagnostic use by healthcare professionals in clinical settings and by people with diabetes at home The system is not...

Page 4: ...aboratory Standards Institute Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition CLSI document M29 A3 2005 The system includes Accu Chek Performa...

Page 5: ...Test 15 Flagging Test Results 18 Unusual Test Results 19 Disinfecting the Meter 21 Chapter 3 Control Testing for Healthcare Professionals 23 Introduction 23 Testing Intervals 23 About the Control Sol...

Page 6: ...and Troubleshooting 45 Changing the Battery 45 Cleaning the Meter 46 Maintenance and Troubleshooting 47 Display Messages and Troubleshooting 48 Chapter 6 Technical Information 55 Product Limitations 5...

Page 7: ...memory adjust settings and scroll through results Test Strip Slot Insert test strip here Infrared IR Window Transfers data from the meter to a computer or PDA Power Set Button Turns the meter on or of...

Page 8: ...ymbol facing up Test Strip Container Control Solution Bottle example Golden End Insert this end of the test strip into the meter Yellow Window Touch blood drop or control solution here Test Strip Top...

Page 9: ...Make sure the meter is off 2 Turn over the meter 3 Remove the old code chip if there is one in the meter and discard it Coding the Meter Change the code chip every time a new box of test strips is ope...

Page 10: ...ave the code chip in the meter until a new box of test strips is opened Change the code chip each time a new box of test strips is opened Notes Do not force the code chip into the meter It is designed...

Page 11: ...e results in memory or to download the results to a computer 1 Press and release to turn on the meter The time and date appear on the display Set up and the hour flash If the correct time and date are...

Page 12: ...ing changed 5 Once the year is set press and hold until the flashing test strip symbol appears The time and date are now set 6 See Chapter 4 Meter Set up to set other options Note After the battery is...

Page 13: ...ntainer with the cap closed Close the container tightly immediately after removing a test strip to protect the test strips from humidity Use the test strip immediately after removing it from the conta...

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Page 15: ...ional information regarding acceptable sample types anticoagulants and handling instructions Testing Blood Glucose in Multiple Patients Only healthcare professionals are allowed to perform blood gluco...

Page 16: ...ient is suspected of being one of the above For as long as the suspicion exists the meter must not be used to test any other patient Any object coming into contact with human blood is a potential sour...

Page 17: ...ger and allow it to dry thoroughly The blood drop does not spread so easily over dry skin 3 Use only a lancing device that is approved for use by healthcare professionals 4 Use a lancing device with a...

Page 18: ...the fingertip to encourage a blood drop to form A proper but nevertheless small blood drop approx 0 6 L must form 10 Immediately after the blood drop has formed touch the drop to the front edge of the...

Page 19: ...17 12 When you see flash you have enough blood in the test strip 13 The result appears on the display 14 Remove and discard the used test strip...

Page 20: ...trol policy flag To test blood glucose you require approximately 0 6 L of blood Avoid producing large blood drops on the patient s finger Where the blood drops are too large the meter may come into co...

Page 21: ...roblem solving Troubleshooting Checks Action 1 Check if the test strips were expired Discard the test strips if they are past the use by date 2 Check if the cap on the test strip container was always...

Page 22: ...ode number on the test strip container If they do not match insert the correct code chip into the meter and test again 7 If the problem does not resolve Repeat the test with a new test strip and perfo...

Page 23: ...ing How to Disinfect Make sure the meter is off Gently wipe the meter s surface Cotton buds wipes and cloths lightly moistened with disinfectant are all suitable for disinfecting the meter Allow areas...

Page 24: ...the area around the test strip slot and the display Allow areas you have wiped time to dry thoroughly The meter including the test strip slot and display must be thoroughly cleaned and disinfected at...

Page 25: ...t testing is allowed Testing Intervals Follow your facility s policy for control testing intervals Control testing should be performed The first time before using the meter for patient testing At inte...

Page 26: ...en acceptably performed at the proper testing interval About the Control Solutions Only use Accu Chek Performa Control Solutions The meter automatically recognises the Accu Chek Performa Control Solut...

Page 27: ...s The meter turns on 2 Make sure the code number on the display matches the code number on the test strip container If the code number is overlooked remove the test strip and reinsert it into the mete...

Page 28: ...the bottle with a lint free wipe 6 Squeeze the bottle until a tiny drop forms at the tip Touch the drop to the front edge of the yellow window of the test strip When flashes sufficient control soluti...

Page 29: ...o mark the result as a Level 2 8 Press and release to set the control level in the meter 9 OK and the control result alternate on the display if the result is in range The range is printed on the test...

Page 30: ...possible cause Were the test strips or control solutions expired Was the tip of the control solution bottle wiped with a lint free wipe before and after use Were the test strip container and control...

Page 31: ...en the battery is replaced however confirm that the time and date are still correct Once 20 control or 500 blood glucose results are in memory adding a new result causes the oldest one to be deleted P...

Page 32: ...st Results 1 Press and release either or to enter memory The most recent result appears 2 Press and release to view previous results in order 3 OR press and release to look at 7 14 or 30 day averages...

Page 33: ...ypo alert select On or OFF If On is chosen select the blood glucose level for the alert The has three functions for the set up mode To enter the set up mode turn on the meter then press and hold until...

Page 34: ...s 2 Press and hold for about 4 seconds to enter the set up mode Set up and the hour flash on the display 3 Press and release or to decrease or increase the hour Note Press and hold or to scroll faster...

Page 35: ...es flash 5 Repeat steps 2 and 3 to set the minutes day month and year The flashing field is the one that is being changed 6 To set up more options press and release To exit press and hold until the fl...

Page 36: ...s complete When a button is pressed If an error occurred while testing even if the beeper is off it beeps for an error If a test reminder is set TIME DATE hrs min day month year BEEPER on off TEST REM...

Page 37: ...The flashing test strip symbol appears 2 Press and hold for about 4 seconds to enter the set up mode Set up and the hour flash on the display 3 Press and release repeatedly until the flashing beeper...

Page 38: ...36 4 Press and release or to switch between On or OFF 5 To set up more options press and release To exit press and hold until the flashing test strip symbol appears on the display...

Page 39: ...this feature If A 1 A 2 A 3 and A 4 are turned on the meter is preset with the following times which can be adjusted as necessary A 1 8 00 A 2 12 00 A 3 18 00 A 4 22 00 Notes If a test was performed w...

Page 40: ...hes continuously 1 Press and release to turn on the meter The flashing test strip symbol appears 2 Press and hold for about 4 seconds to enter the set up mode Set up and the hour flash on the display...

Page 41: ...to switch between On and OFF Press and release to set the option 5 If On is selected the hour flashes A 1 and the bell symbol remain on the display 6 Press and release or to select the hour Press and...

Page 42: ...are the only choices 8 Press and release to set the minutes 9 The next reminder A 2 and set up flash on the display with OFF and the bell symbol A second reminder can be set or press and hold until th...

Page 43: ...alert function when using the meter in a professional facility TIME DATE hrs min day month year BEEPER on off TEST REMINDERS A 1 A 2 A 3 A 4 HYPO ALERT off on level You are here 1 Press and release t...

Page 44: ...set the option 5 If On is selected set up and flash The display shows 3 9 mmol L first use or the current level 6 Press and release or to select the level Press and release to set the level 7 To exit...

Page 45: ...sults 1 Install the software according to the instructions To transfer the results to a computer connect the infrared meter cable according to the instructions 2 Run the software program and follow th...

Page 46: ...uld be 3 10 cm apart 7 Do not move the infrared cable computer PDA or meter during the transfer 8 Follow the prompts on the software 9 The software program may shut off the meter automatically when th...

Page 47: ...on of the arrow and pulling the door up Remove the old battery 2 Insert the new battery with the side up 3 Put the battery door back in place and snap it closed 4 Turn on the meter Confirm that the ti...

Page 48: ...l Mild dishwashing liquid mixed with water 10 household bleach solution 1 part bleach plus 9 parts water made the same day DO NOT Get any moisture in the code chip and test strip slot Spray any cleani...

Page 49: ...rned on and prompts the operator for any errors See Chapter 5 Display Messages and Troubleshooting If the meter is dropped or the accuracy is in question contact Roche To check the display turn off th...

Page 50: ...isplay is blank Battery is dead Insert new battery Display is damaged Contact Roche Meter is defective Contact Roche Extreme temperatures Move the meter to a more temperate area Display Messages and T...

Page 51: ...See Chapter 2 Flagging Test Results for more details The meter is ready for you to insert a test strip The meter is ready for a drop of blood or control solution Blood glucose may be higher than the...

Page 52: ...st strips and ensure the code chip number matches the code number on the test strip container Make sure the time and date in the meter are correct The test strip is damaged Remove the test strip and r...

Page 53: ...epeat the test and refer to Chapter 2 Unusual Test Results If this does not confirm symptoms perform a control test with the control solution and a new test strip If the control result is within the a...

Page 54: ...repeat the test An electronic error occurred or in rare cases a used test strip was removed and reinserted Turn the meter off and on or take the battery out for 20 seconds and reinsert it Perform a bl...

Page 55: ...see any other error display please contact Roche The battery is almost out of power Change the battery now The time and date settings may be incorrect Make sure the time and date are correct and adjus...

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Page 57: ...ackage insert Measuring range Refer to the test strip package insert Test strip storage conditions Refer to the test strip package insert Meter storage conditions 25 70 C System operating conditions R...

Page 58: ...requirements as per EN ISO 15197 Annex A The chosen basis for electrostatic discharge immunity testing was basic standard IEC 61000 4 2 In addition it meets the electromagnetic emissions requirements...

Page 59: ...er and Batteries During blood glucose measurement the meter itself may come into contact with blood Used meters therefore carry a risk of infection Please dispose of used meters after removing the bat...

Page 60: ...mpanying documents Please refer to safety related notes in the instructions for use accompanying this instrument Temperature limitation Store at Manufacturer Catalogue number Listed by Underwriter s L...

Page 61: ...y Additional Supplies The following supplies and accessories are available from authorised Roche Diabetes Healthcare Centres pharmacies or medical surgical supply dealers Test Strips Accu Chek Inform...

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Page 63: ...3 control solution 24 control test performing 25 control test results understanding out of range 28 D display check 47 display messages 48 53 E error messages 50 53 F flagging test results 18 G guaran...

Page 64: ...settings meter 31 supplies 59 symbols 58 T technical information 55 test reminders setting 37 test results unusual 19 20 test strips Accu Chek Inform II 6 11 time and date setting 32 troubleshooting 4...

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Page 67: ...s Limited Charles Avenue Burgess Hill West Sussex RH15 9RY United Kingdom Accu Chek Customer Careline1 UK Freephone number 0800 701 000 ROI Freephone number 1 800 709 600 1 calls may be recorded for t...

Page 68: ...GmbH Sandhofer Strasse 116 68305 Mannheim Germany www accu chek com ACCU CHEK ACCU CHEK PERFORMA ACCU CHEK INFORM and SAFE T PRO are trademarks of Roche 2010 Roche Diagnostics All rights reserved 057...