STANDARD OPERATING PROCEDURE ACCU-CHEK GO

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2 1. Scope This Standard Operating Procedure (SOP) applies to the staff and students using the ACCU-CHEK Go in the Pharmacy Practice Resource Unit (PPRU) at the Pharmacy Department, University of Malta. 2. Objective To describe the procedure for the configuration, operation, quality control check, data transfer, maintenance and troubleshooting of the ACCU-CHEK Go. 3. Definitions 3.1. and Buttons: To change settings and to retrieve results and averages from memory Acoustic Mode: Guides the user through the testing process using beep tones and is especially useful for persons who are visually impaired Accu-Chek Go: A blood glucose device used to quantitatively measure blood glucose levels using capillary blood Alarm Clock Function: Alerts the operator or patient that it is time to conduct a glucose test. Three separate alarm times can be set simultaneously Battery Compartment: The area in which a CR2032 battery is to be inserted Code Chip: Provides the device with important information about the test method, the lot number and the expiry date of the test strips being used. Each container of test strips comes with a new code chip that should be inserted into the device when the new container of strips is to be used Code Chip Slot: Area in which the code chip is inserted Control Solution: Solution used to perform a quality control check. There are 2 different control solutions available depending on their glucose concentration i.e. Control G1 containing a low glucose concentration and Control G2 containing a high glucose concentration Display Test: Checks that all display parameters are being shown. Page 2 of 21

3 3.10. Infrared Window: To be pointed towards the infrared window of an infrared port of a computer whenever data is to be downloaded from the device to a computer that has the appropriate software installed Measurement Optics: The part of the device which uses light to quantitatively measure the glucose concentration in the blood; it is located underneath the measurement optics cover Memory Function: Function that allows storage of up to 300 different test results together with their relevant time and date. Once this memory is full, the device will start to automatically overwrite the oldest entries consecutively. Control test results are saved with an accompanying control solution bottle symbol, flagged results are saved with an asterisk and results that are obtained at a temperature outside the permitted temperature range are saved with an accompanying thermometer symbol. Only the most recent result can be erased from memory with its time and date information still retained as a reminder, thus leaving its memory location occupied On/Off Button: To turn the device On or Off, to enter Set Up Mode and to save entries Quality Control Check: Performed to ensure that both the device and the test strips are functioning appropriately and providing reliable results. This check should be carried out before the device is used for the first time, when starting a new box of test strips, when inserting a new battery, after a cleaning procedure, after accidentally dropping the device and when test results are not coinciding with the clinical symptoms present Set Up Mode: Allows the device to be set according to the user s preferences and contains the following four configuration parameters: time and date format, beep tone, target range and alarm clock function (refer to /A1) Test Strip Guide: The area in which the test strip is inserted. Page 3 of 21

4 4. Responsibility 4.1. The members of the Department of Pharmacy (staff and students) are responsible for following this SOP The designated Laboratory Officer or Laboratory Assistant is responsible for ensuring that this SOP is followed. 5. Procedure 5.1. Diagram of ACCU-CHEK Go Infrared Port On/Off Button Code Chip Slot Display and buttons Test Strip Ejector Measurement Optics Cover Test Strip Guide 5.2. Configuration Insert battery into the battery compartment Insert the code chip that came with the test strips to be used, into the code chip slot Press the and buttons simultaneously to perform a display test Press any button to terminate the display test and to switch the device Off. Page 4 of 21

5 Press and hold the On/Off button for more than 3 seconds to enter Set Up mode Refer to /A1 to set up the different configuration parameters available Operation Check that the measurement optics cover is appropriately attached before starting the test Remove a test strip from its storage container and replace its cap tightly Insert the test strip into the test strip guide with the printed arrows pointing towards the test strip guide Gently keep pushing the test strip inwardly until resistance is felt Wait for the device to switch On automatically Wait for the display test to take place, lasting approximately 2 seconds Check that all segments of the displayed numerals (888mg/dL or 88.8mmol/L) are being displayed Check that the displayed code number coincides with the code present on the test strip container Wait for the flashing test strip and blood drop symbols to be displayed. (A blood drop must now be applied to the test strip within 90 seconds.) Hold the device with the test strip pointing downwards Touch the blood drop against the tip of the test strip where the black notch is located Move the finger away from the test strip when an hourglass symbol is displayed Wait for the test result to be displayed, where it will be automatically saved in memory Repeatedly press the or button until [ * ] is displayed if flagging of a result is required If several beep tones are heard during result display, the test result obtained is either below the lower limit or above the upper limit target value Hold the device in such a way as to allow the test strip to point downwards Push the test strip ejector as far as it will go to eject the test strip into a sharps container for disposal. The device will switch Off automatically. Page 5 of 21

6 Accessing Memory Press the or button while the device is switched Off Wait for the most recent test result to be displayed Repeatedly press the button if older test results need to be displayed Press the button, whilst viewing the most recent result, if the average test result for the last 7 days needs to be displayed Press the button again if the average test result for the last 14 days needs to be displayed Press the button again if the average test result for the last 30 days needs to be displayed Press the On/Off button to exit memory and switch the device Off Deleting Memory Press and hold the and buttons simultaneously while the device is switched Off until [CLr] is displayed Press and hold the and buttons simultaneously until the most recent saved result is seen flashing Press and hold the and buttons simultaneously until [- - -] is displayed Press the On/Off button to switch the device Off Quality Control Check Repeat steps to Wait for the flashing test strip and blood drop symbols to be displayed. (A drop of the control solution must now be applied to the test strip in 90 seconds.) Open the desired bottle of control solution and wipe its dropper tip with a clean, dry paper towel to remove any dried-up residues Invert the bottle and hold it downwards at an angle Squeeze the bottle gently until a small drop is suspended from the tip Hold the device in such a way as to allow the test strip to point downwards Touch the drop of the solution against the tip of the test strip where the black notch is located Move the control solution away from the test strip when the hourglass symbol is displayed. Page 6 of 21

7 Wait for the control result to be displayed, which is automatically saved in memory Repeatedly press the or button until a control bottle symbol is displayed to mark the result as a control Check that the control result obtained lies within the specified range of the control solution found printed on the test strip container Re-perform the quality control check, following all the necessary precautions, if the control result lies outside the specified range Contact the supplier if the second control result also lies outside the specified range Push the test strip ejector as far as it will go to eject the test strip into a sharps container for disposal. The device switches Off automatically Data Transfer Run the appropriate installed software programme in the computer Check that the software programme is ready to accept data from the device Press the On/Off and the buttons simultaneously Wait for a flashing [PC] to be displayed Position the device approximately 10-20cm away from the infrared port of the receiving end of the computer Point the infrared window towards the infrared window port of the computer If [PC] continues to flash or the meter switches Off automatically after approximately 90 seconds, the data transfer process was unsuccessful or was incomplete and should be repeated Wait until [End] is displayed to indicate that the information has been successfully transferred to the computer Press the On/Off button to turn the device Off Maintenance Replace the battery with a new one if a battery symbol is displayed Clean the outside of the device and the display with a moist cloth Disinfect the outside of the device and the display with a cloth moistened with 70% ethanol If blood is present in the test strip guide or the device is displaying an E4 error message: Push the measurement optics cover upwards in the direction of the small arrow and lift it off. Page 7 of 21

8 5.7. Troubleshooting Clean the measurement optics with a cotton swab dampened with 70% ethanol Allow sufficient time for the surfaces to thoroughly dry up Remove any remaining fluff or lint Place the measurement optics cover back into place and press it downwards Perform a quality control check (refer to section 5.4.) before commencing further testing procedures. Error Cause/s Solution/s [code] flashing after display test is performed Code chip is missing [exp] displayed on flashing test strip symbol Flashing thermometer symbol displayed alongside test result Low battery symbol displayed [PC] continues to flash or meter switches Off automatically during data transfer Lo displayed Hi displayed Test strip used is expired Temperature is outside of permitted range of 10 o C to 4 0o C Battery strength is low and can only perform approximately 50 more tests Data transfer did not occur or was incomplete Result is lower < 10mg/dL or 0.6mmol/L Result is > 600mg/dL or 33.3mmol/L Page 8 of 21 Insert appropriate code chip Check that correct date is inputted. Perform test with a new test strip from new container. Do not use result as a basis for therapeutic decisions. Slowly acclimatise device at T within permitted range and re-perform test. Replace battery with a new one as soon as possible - Reduce distance between the two infrared ports to 10-20cm and position them so as to point towards each other - Move away from any interrupting light source that may be present - Repeat download process Re-perform test ensuring that correct amount of blood is transferred onto test strip Re-perform test ensuring that correct amount of blood is transferred onto test strip

9 E-1 displayed E-2 displayed E-4 displayed E-6 displayed EEE displayed Test strip inserted incorrectly or incompletely Code chip inserted incorrectly or wrong code chip inserted - Measurement optics is dirty or have inserted a used or expired test strip - Blood or control solution was applied too early Blood / Control Solution volume was insufficient Device error Gently insert test strip with arrows pointing towards the meter, until it fits accordingly Insert the corresponding code chip accordingly - Clean measurement optics and repeat test with a new test strip - Re-perform test with a new test strip and wait for test strip symbol and flashing blood drop to be displayed before applying blood drop or control solution to test strip - Contact supplier if error re-appears Repeat test with a new test strip and a larger amount of blood or control solution Remove test strip and repeat test. Contact supplier if error message reappears Page 9 of 21

10 5.8. Flow Chart Configuration Start Insert battery into battery compartment Insert appropriate code chip into code chip slot Press and buttons simultaneously to perform display test Press any button to terminate display test and to switch device Off Press On/Off button for more than 3 seconds to enter Set Up mode Refer to /A1 to set up the different configuration parameters End Page 10 of 21

11 Operation Start Check that measurement optics cover is appropriately attached before starting Remove test strip from storage container and replace its cap tightly Insert test strip into test strip guide with printed arrows pointing towards test strip guide Gently keep pushing test strip inwardly until resistance is felt Wait for device to switch On automatically Wait for display test to take place Check that all segments of the displayed numerals are being displayed Check that displayed code number coincides with code number present on test strip container Wait for flashing test strip and blood drop symbols to be displayed A blood drop must now be applied to test strip within 90 seconds Hold device with test strip pointing downwards Touch blood drop against tip of test strip where black notch is located 1 Page 11 of 21

12 1 Move finger away from test strip when an hour glass symbol is displayed Wait for test result to be displayed, which is automatically saved in memory Need to flag result Several beep tones heard during result display Repeatedly press or button until [*] is displayed Test result is either below lower limit or above upper limit target value Hold device in such a way as to allow test strip to point downwards Push test strip ejector as far as it will go to eject test strip into a sharps container for disposal Device will switch Off automatically Need to access memory 2 Press or button while device is switched Off Wait for most recent test result to be displayed Need to display older test results Need to display average test result for last 7 days 4 Repeatedly press button 3 Page 12 of 21

13 3 Press button whilst viewing the most recent result Need to display average test result for last 14 days Press button Need to display average test result for last 30 days 4 Press button Press On/Off button to exit memory and switch device Off 2 Need to delete memory Press and hold and buttons simultaneously while device is switched Off until [CLr] is displayed Press and hold and buttons simultaneously until most recent saved result is seen flashing Press and hold and buttons simultaneously until [ - - -] is displayed Press On/Off button to switch Off device End Page 13 of 21

14 Quality Control Check Start Check that measurement optics cover Is appropriately attached before starting Remove test strip from its container and replace cap tightly Insert test strip into test strip guide with printed arrows pointing towards the test strip guide Gently keep pushing test strip inwardly until resistance is felt Wait for device to switch On Wait for display test to take place Check that all segments of the displayed numerals are being displayed Check that displayed code number coincides with code number present on test strip container Wait for flashing test strip and blood drop symbols to be displayed A drop of control solution must now be applied to test strip within 90 seconds Open desired bottle of control solution Wipe its dropper tip with a clean, dry paper towel to remove any dried-up residues 1 Page 14 of 21

15 1 Invert bottle and hold it downwards at an angle Squeeze bottle gently until a small drop is suspended from tip Hold device is such a way as to allow test strip to point downwards Touch drop of solution against tip of test strip where black notch is located Move control solution away from test strip when hour glass symbol is displayed Wait for control result to be displayed, which is automatically saved in memory Repeatedly press or button until control bottle symbol is displayed to mark result as a control Check that control result lies within the specified range of control solution found printed on test strip container Result lies outside specified range Re-perform quality control check following all necessary precautions Push test strip ejector as far as it will go to eject test strip into a sharps container End Second control result lies outside specified range Contact supplier Page 15 of 21

16 Data Transfer Start Run appropriate installed software programmes in computer Check that software programme is ready to accept data from device Press On/Off and buttons simultaneously Wait for flashing [PC] to be displayed Position device approximately 10-20cm away from infrared port of receiving end of computer Point infrared window towards infrared window port of computer [PC] continues to flash or meter switched off automatically after approx 90 seconds Data transfer process was unsuccessful or incomplete Wait until [End] is displayed to indicate that data has been successfully transferred to computer Press On/Off button to turn device Off End Page 16 of 21

17 Maintenance Start Battery symbol displayed Replace battery with a new one Device or display needs cleaning/disinfection Clean with a moist cloth and disinfect using 70% ethanol Blood present in test strip guide E4 error message displayed Push measurement optics cover upwards and direction of small arrow and lift it off Clean measurement optics with cotton swab dampened with 70% ethanol Allow sufficient time for surfaces to thoroughly dry up Remove any remaining fluff or lint Place measurement optics cover back into place and press it downwards Perform a quality control check (refer to section ) before commencing further testing procedures End Page 17 of 21

18 6. Precautions 6.1. The ambient temperature of the area where a test is to be performed must be within the range of 10 to 40 o C Operate the device in an environment that has a humidity level less than 85% Do not use the device in close proximity of strong electromagnetic radiation sources Keep the device away from very strong light sources since this may cause error messages to be displayed more frequently Ensure that the measurement optics cover is firmly and properly attached to the device each time a test is being carried out since improper attachment can lead to incorrect results being obtained Always hold the device in such a way as to allow the test strip to point downwards towards the blood drop and not pointing upwards or sideways to prevent blood from entering the device Always wait for the device to switch Off automatically after each test before commencing with further tests Avoid scratching the measurement optics during its cleaning process since this will impair the measuring function of the device Ensure that no liquid enters into the device during the cleaning process Do not spray any kind of cleaning solution onto the device Remove the battery from the device whenever it is not going to be used for long periods of time Do not store test strips in areas of high heat and moisture Do not bend the test strip whilst it is being inserted into the device Do not test blood glucose with expired test strips Do not bend or move the test strip whilst a test is in progress since this can lead to an incorrect result Always use the test strip ejector to remove the used test strip to prevent blood from entering the device and contaminating it Do not allow the test strip to draw up control solution that has trickled down the outside of the bottle dropper since this can possibly generate results that are too high Once open, control solutions remain stable for only three months. Do not use if this period has elapsed. 7. Reference Roche Diagnostics GmbH. Accu-chek Go blood glucose meter instructions for use. Germany (Mannheim): Roche Diagnostics; Page 18 of 21

19 8. Appendices /A1 Configuration Parameters Table 9. Revision History Version Number Amendments/ Reasons for change 01 Initial Release 02 Inclusion of subheading titles of Procedure section in Table of Contents Page 19 of 21

20 /A1 Configuration Parameters Table Configuration Parameter Time and Date Format Beep Tone Target Range Display Symbol F1 F2 F3 Set Up - Press and hold On/Off button for more than 3 seconds - Press On/Off button to enter F1 mode - Use / buttons to select desired time and date format - Press On/Off button to confirm - Use / buttons to select hour - Press On/Off button to confirm - Use / buttons to select minutes - Press On/Off button to confirm - Use / buttons to select year - Press On/Off button to confirm - Use / buttons to select month - Press On/Off button to confirm - Use / buttons to select day - Press On/Off button to confirm - Press On/Off button to continue with next configuration parameter - Press and hold On/Off button for more than 3 seconds to save, exit Set Up Mode and turn Off device - Press and hold On/Off button for more than 3 seconds - Repeatedly press / buttons until F2 is displayed - Press On/Off button to enter F2 mode - Use / buttons to choose between switching Off [OFF] or switching On the beep tone [On1] or else to activate the acoustic mode [On2] - Press On/Off button to confirm - Press On/Off button to continue with next configuration parameter - Press and hold On/Off button for more than 3 seconds to save, exit Set Up Mode and turn Off device - Press and hold On/Off button for more than 3 seconds - Repeatedly press / buttons until F3 is displayed - Press On/Off button to enter F3 mode Page 20 of 21

21 Alarm clock function F 4 - Use / buttons to select between switching On or Off the lower limit target range - Press On/Off button to confirm - If On is chosen, use / buttons to select desired value for lower limit target range and press On/Off button to confirm - Use / buttons to select between switching On or Off the upper limit target range - Press On/Off button to confirm - If On is chosen, use / buttons to select desired value for upper limit target range and press On/Off button to confirm - Briefly press On/Off button to continue with next configuration parameter - Press and hold On/Off button for more than 3 seconds to save, exit Set Up Mode and turn Off device - Press and hold On/Off button for more than 3 seconds - Repeatedly press / buttons until F4 is displayed - Press On/Off button to enter F4 mode - Use / buttons to select between switching On or Off the first alarm - Press On/Off button to confirm - If On is chosen: o Use / buttons to select hour o Press On/Off button to confirm o Use / buttons to select minutes o Press On/Off button to confirm - If desired, repeat procedure for the subsequent 3 alarms i.e. [AL2], [AL3] and [AL4] - Press and hold On/Off button for more than 3 seconds to save, exit Set Up Mode and turn Off device Page 21 of 21

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