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Appendix E: References

1. FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk

for Transmitting Bloodborne Pathogens: Initial Communication, (2010). Update 11/29/2010”
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. Accessed March 20, 2012.

2. CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting

Bloodborne Pathogens, (2010).” http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
Accessed March 20, 2012.

3. Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, Ph.D., M.P.H., and

David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. “Guideline for Disinfection
and Sterilization in Healthcare Facilities. Atlanta.”

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Summary of Contents for Aviva

Page 1: ...Roche Diagnostics Assembled in USA Distributed by Roche Health Solutions Inc 11800 Exit 5 Parkway Suite 120 Fishers IN 46034 Phone 1 800 280 7801 Fax 1 888 810 0758 ACCU CHEK ACCU CHEK AVIVA ACCU CHEK AVIVA COMBO ACCU CHEK SPIRIT COMBO and FASTCLIX are trademarks of Roche The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by Roche is un...

Page 2: ...LAST UPDATE 2012 08 51638_00048010155_C indb 2 6 11 13 3 57 PM ...

Page 3: ...iner cap or if anything prevents the cap from closing properly do not use the test strips Contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 Damaged test strips can cause inaccurate results which could lead to improper treatment Carefully dispose of used test strips and lancets Home use of the ACCU CHEK Aviva Combo system is limited to capillary whole blood testing Roche USA 51638 V4...

Page 4: ... you always apply whole blood to the test strip the system has been calibrated to deliver plasma like values for easier comparison to lab results The meter test strips and control solution are only for use outside the body in vitro Do not eat the test strips Do not swallow or inject the control solution or use the control solution for any purpose other than testing the ACCU CHEK Aviva Combo system...

Page 5: ...t when you open a new box of test strips or if you think that your test result is incorrect Running a control test lets you know that the meter and test strips are working properly If peripheral circulation is impaired collection of fresh capillary whole blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level This m...

Page 6: ... YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT If your blood glucose result doesn t match how you feel and you have followed the instructions in your owner s booklets follow your healthcare professional s instructions or call your healthcare professional Special Information to Consider When Using This Meter Do not use this device to measure blood glucose if you or a person to...

Page 7: ...The ACCU CHEK Aviva Combo Meter at a Glance 13 1 3 The ACCU CHEK Spirit Combo Insulin Pump at a Glance 19 1 4 Summary of Features 20 1 5 Screen Content and Navigation 30 2 Testing Your Blood Glucose 39 2 1 Overview 40 2 2 Using the ACCU CHEK Aviva Combo System 41 2 3 Performing a Blood Glucose Test 43 51638_00048010155_C indb 1 6 11 13 3 57 PM ...

Page 8: ...rol Testing 63 3 1 Overview 64 3 2 Why Perform Control Tests 65 3 3 About the Control Solutions 66 3 4 Performing a Control Test 67 3 5 Understanding Control Test Results 73 4 Managing Your Data 79 4 1 Overview 80 4 2 Viewing or Modifying Your Data 83 4 3 Adding New Data 92 4 4 Reporting Your Data 95 4 5 Downloading Your Data to a Computer 133 51638_00048010155_C indb 2 6 11 13 3 57 PM ...

Page 9: ...ime Blocks Health Events Advice Options Bolus Advice Set Up 161 5 7 Setting Warning Limits Hyper Hypo 170 5 8 Turning Key Lock On or Off 173 5 9 Setting the Language 176 5 10 Setting Units Carbs 179 5 11 Turning Bluetooth Wireless Technology On or Off 182 5 12 Pairing the Meter and Pump 184 5 13 Setting the Beeper Vibrate Key Sound 185 5 14 Setting the Time Format Time Date 188 5 15 Setting Time B...

Page 10: ...ings 216 6 6 List of Errors 222 7 Cleaning and Disinfecting the Meter and Lancing Device 225 7 1 Overview 226 7 2 Cleaning and Disinfecting the Meter 228 7 3 Cleaning and Disinfecting the Lancing Device 233 8 Maintenance 237 8 1 Overview 238 8 2 Changing the Batteries 239 8 3 Power Saving Tips 242 8 4 Maintenance and Testing 243 51638_00048010155_C indb 4 6 11 13 3 57 PM ...

Page 11: ...s 268 10 4 Product Safety Information 270 10 5 Disposing of the Meter Strips Lancets and Batteries 273 10 6 Warranty and Limited License 275 10 7 Additional Supplies 282 Appendices 283 Appendix A Abbreviations 283 Appendix B Carb Units 285 Appendix C Explanation of Symbols 286 Appendix D Meter Settings and Range Limits 287 Appendix E References 292 51638_00048010155_C indb 5 6 11 13 3 57 PM ...

Page 12: ...6 Glossary 293 Index 301 51638_00048010155_C indb 6 6 11 13 3 57 PM ...

Page 13: ...data Changing the meter settings Understanding the icons reminders warnings and errors Maintenance Cleaning and disinfecting the meter and lancing device Troubleshooting Technical information Introduction Whether the ACCU CHEK Aviva Combo meter is your first blood glucose meter or you have used a meter for some time please take the time to read the Getting Started Guide the Standard Owner s Bookle...

Page 14: ...Bolus advice Daily time blocks that can be adjusted to fit your lifestyle Data management Data transfer Date reminders bG test reminders Alarm clock Target bG levels and Health events An electronic diary that allows you to enter meal time carbs health and bolus information with your blood glucose test results For detailed information about the features of the meter see Chapter 1 Understanding Your...

Page 15: ...h the ACCU CHEK Aviva Combo blood glucose meter to quantitatively measure glucose sugar in fresh capillary whole blood samples drawn from the fingertips The ACCU CHEK Aviva Combo meter can also be used to interface with and remotely control the ACCU CHEK Spirit Combo insulin infusion pumps via radio frequency communication The ACCU CHEK Aviva Combo meter is also indicated for the management of dia...

Page 16: ...xercise and food plans can help you better control your diabetes Important Information About Your New Meter The meter is designed for testing fresh whole blood samples for example blood from your fingertip The meter is for outside the body in vitro use It should not be used to diagnose diabetes This meter requires ACCU CHEK Aviva Plus test strips Other test strips will give inaccurate results The ...

Page 17: ...m 1 1 Overview 12 1 2 The ACCU CHEK Aviva Combo Meter at a Glance 13 1 3 The ACCU CHEK Spirit Combo Insulin Pump at a Glance 19 1 4 Summary of Features 20 1 5 Screen Content and Navigation 30 51638_00048010155_C indb 11 6 11 13 3 57 PM ...

Page 18: ...ter correctly NOTE This booklet shows sample screens The screens in this booklet may look slightly different from the screens on the meter If you have any questions about the meter screens contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 Blood glucose and bG are interchangeable and mean the same thing 51638_00048010155_C indb 12 6 11 13 3 57 PM ...

Page 19: ... to select the menu or option above the key Power On Off Button Turns the meter on or off Test Strip Slot Insert golden end of test strip here Infrared IR Window Transfers data from the meter to a computer Code Key Slot Black code key is pre inserted here Battery Door Remove the battery door by pushing the tab and pulling up the door Backlight Button Press to adjust the backlight level 51638_00048...

Page 20: ...symbols in the battery compartment Control Solution Bottle for example Yellow Window Touch blood drop or control solution here Golden End Insert this end of the test strip into the meter Test Strip Container for example 51638_00048010155_C indb 14 6 11 13 3 57 PM ...

Page 21: ...ven if you use test strips from test strip boxes that contain another code key that is a different color or has different code numbers you never need to change the black code key again Side View Pre inserted black code key Code Key for example Top View Infrared IR Window 51638_00048010155_C indb 15 6 11 13 3 57 PM ...

Page 22: ...d unless you turned off the key sound Press or insert a test strip to turn on the meter If the meter displays the Time Date screen make the necessary changes and select Save Left Soft Key Up Arrow Enter Left Arrow Power On Off Right Soft Key Right Arrow Down Arrow Backlight 51638_00048010155_C indb 16 6 11 13 3 57 PM ...

Page 23: ...wn in a screen Left Soft Key j Select the option above the key on the display Right Soft Key j Select the option above the key on the display Enter j Select a menu or option j Save changes and exit the entry field Backlight j Adjust the backlight level low medium high j Turn Bluetooth wireless technology on and off press and hold in the BLUETOOTH screen Power On Off j Turn the meter on and off 516...

Page 24: ...ion When the buttons are locked press and hold and until the Main Menu appears Unlock Keys j Unlocks the buttons With the meter turned off press and hold and then press Meter Pump Pairing j Begins meter and pump pairing 51638_00048010155_C indb 18 6 11 13 3 57 PM ...

Page 25: ...y Shows menus messages and data stored in the pump memory Up Key Moves forward in an information screen increases a setting turns on the backlight programs a Quick Bolus cancels a Quick Bolus and turns off the STOP Warning Down Key Moves backward in an information screen decreases a setting programs a Quick Bolus cancels a Quick Bolus and turns off the STOP Warning Infusion Set Connects the pump t...

Page 26: ...level by pressing and releasing the backlight button The backlight adjusts from low to medium to high and back to low again If set to the medium or high level and the buttons are not pressed for about 15 seconds the backlight returns to the low level to save power When the meter returns to the low level pressing any button restores the previous backlight level For more information about backlight ...

Page 27: ...or more information see Chapter 6 Icons Reminders Warnings and Errors Blood Glucose Test Your new meter allows you to enter detailed information for each blood glucose test to include Meal time Pre meal Post meal Bedtime or other Carbs the amount of carbohydrates you are intending to eat Health events Exercise 1 Exercise 2 Stress Illness Premenstrual or Fasting If bolus advice is set up on the met...

Page 28: ...s on how to set up bolus advice see Chapter 5 Changing Meter Settings WARNING Before setting up bolus advice it is very important to read all of the safety information in the Advanced Owner s Booklet and talk to your healthcare professional Using the Meter with the Pump The meter can communicate with and remotely control your pump Pump information is automatically downloaded to the meter when Blue...

Page 29: ...syringe My Data Your new meter stores 1 000 records in the diary You can view modify or add information to your diary You can view blood glucose test averages trends standard day standard week and target tables and graphs of the data in the diary You can view the data in graph or table format for the last 7 14 30 60 or 90 days For more information see Chapter 4 Managing Your Data 51638_00048010155...

Page 30: ... that best fit your needs Whenever a blood glucose test result is above or below this range the meter displays a warning In addition Trend Graph screens indicate the hypo warning limit when displaying your blood glucose test results For more information see Chapter 4 Managing Your Data The meter has default warning limits that can be adjusted For more information see Chapter 5 Changing Meter Setti...

Page 31: ...ucose are affected by your daily activities and lifestyle Time blocks can be set up with or without bolus advice Talk to your healthcare professional about the best way to set up your time blocks to assist you in managing your diabetes The meter has 5 default time blocks You may set up to 8 time blocks For more information see Chapter 5 Changing Meter Settings 51638_00048010155_C indb 25 6 11 13 3...

Page 32: ...e following when setting up time blocks Determine the appropriate time range by reviewing the end time for each time block Review the acceptable blood glucose target range low and high for each time block Determine your carb ratio the amount of insulin needed to cover a given amount of carbohydrates for each time block Determine your insulin sensitivity the amount of insulin needed to lower your b...

Page 33: ... Fasting if you set up bolus advice Fasting does not scale bolus advice calculations and is not adjustable Health events available on the meter are Exercise 1 Exercise 2 Stress Illness Premenstrual Fasting Discuss the appropriate percentage for each health event with your healthcare professional For instructions on how to set up bolus advice see Chapter 5 Changing Meter Settings 51638_00048010155_...

Page 34: ... 240 mg dL and with a reminder time of 60 minutes You have a blood glucose test result higher than 240 mg dL perhaps 270 mg dL In 60 minutes the meter reminds you to perform another blood glucose test The after meal bG test reminder is set up with a carb value and occurs when the carb value exceeds the snack size Any of these blood glucose test reminders can be turned on or off individually as nee...

Page 35: ...rs for Other for any other daily reminder You can set up to eight reminders per day For more information see Chapter 5 Changing Meter Settings Date Reminders The meter can be set up to remind you of upcoming appointments or dates such as a Dr Visit a Lab Test or an Infusion Set Change For more information see Chapter 5 Changing Meter Settings 51638_00048010155_C indb 29 6 11 13 3 57 PM ...

Page 36: ...ction provides an explanation of how to understand and navigate the screens on the meter Each time the meter is turned on this splash screen ACCU CHEK logo screen is displayed for a short period of time 51638_00048010155_C indb 30 6 11 13 3 57 PM ...

Page 37: ...nology Icon Indicates whether the Bluetooth wireless technology is on off or connecting Features on the Main Menu NOTE To select an item on a menu press x or z to highlight blue the menu item and then press When using the meter to remotely control your pump the buttons of your meter have differing functions For more information see the Advanced Owner s Booklet 51638_00048010155_C indb 31 6 11 13 3...

Page 38: ...me using the meter Icon Communication State Bluetooth wireless technology is on The meter and pump are communicating Bluetooth wireless technology is off The meter and pump are not communicating Bluetooth wireless technology is on However the meter and pump are not communicating 51638_00048010155_C indb 32 6 11 13 3 57 PM ...

Page 39: ...1 33 This screen appears when Bluetooth wireless technology is on and the meter is connecting to the pump Connecting to the Pump screen during pairing 51638_00048010155_C indb 33 6 11 13 3 57 PM ...

Page 40: ...ion above the button on the screen Highlighted Option When a menu choice or item is selected it is highlighted in blue Scroll Bar If there is more information available than fits on the screen a vertical scroll bar appears on the right side of the screen Right Soft Key Option Press to select the option above the button on the screen Features on a screen 51638_00048010155_C indb 34 6 11 13 3 57 PM ...

Page 41: ...st be selected it appears as a pop up menu To open a pop up menu or entry field press Press x or z to select the appropriate pop up menu option or until the correct numerical entry is present and then press Press and hold x or z to scroll faster Pop Up Entry Field Pop Up Menu 51638_00048010155_C indb 35 6 11 13 3 57 PM ...

Page 42: ... Navigation Steps To change the settings or enter information into the meter 1 j Press x or z to select a menu option and press j Repeat the previous step as necessary 51638_00048010155_C indb 36 6 11 13 3 57 PM ...

Page 43: ...s and return to the previous screen j Press x or z or or to select an option or a desired entry field and press 2 j Press x or z to select the desired entry and press j Repeat Steps 2 and 3 as necessary 3 51638_00048010155_C indb 37 6 11 13 3 57 PM ...

Page 44: ...38 51638_00048010155_C indb 38 6 11 13 3 57 PM ...

Page 45: ...a Combo System 41 2 3 Performing a Blood Glucose Test 43 2 4 Detailed Blood Glucose Test Results 51 2 5 Understanding Blood Glucose Test Results 55 2 6 Unusual Blood Glucose Test Results 59 2 7 Symptoms of High or Low Blood Glucose 61 51638_00048010155_C indb 39 6 11 13 3 57 PM ...

Page 46: ...0 2 1 Overview It is important to understand how to perform a blood glucose test properly NOTE Blood glucose and bG are interchangeable and mean the same thing 51638_00048010155_C indb 40 6 11 13 3 57 PM ...

Page 47: ...container Do not use the test strips after that date If the Use By date is missing or cannot be read do not use the test strips Do not refrigerate freeze or expose strips to heat moisture or humidity Temperatures outside the required range as well as moisture and humidity can damage your test strips and lead to inaccurate results Refer to the test strip package insert for system operating conditio...

Page 48: ...re test strips in extreme temperatures or moisture areas bathroom kitchen laundry room car or garage Heat and moisture can damage your test strips Do not bend cut or alter the test strips Do not get dirt food or other material on the test strips 51638_00048010155_C indb 42 6 11 13 3 57 PM ...

Page 49: ...never be used by more than one person Do not share the meter and lancing device with anyone including family members due to the risk of infection from bloodborne pathogens 1 2 If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person Disinfect the meter and lanci...

Page 50: ...not match how you feel perform a fingertip test to confirm your result If the fingertip test result still does not match how you feel contact your healthcare professional NOTE If you need to perform a control test only use ACCU CHEK Aviva control solutions See Chapter 3 Control Testing for more information about control testing 51638_00048010155_C indb 44 6 11 13 3 57 PM ...

Page 51: ... Blood Glucose Test Prepare Check the Use By Date Insert Test Strip Test Blood Sample bG Test Result 2 j Check the Use By date on the test strip container Do not use test strips past the Use By date 3 j Insert the golden end of a test strip into the meter in the direction of the arrow The meter turns on 51638_00048010155_C indb 45 6 11 13 3 57 PM ...

Page 52: ...est strip is ready for testing 4 Fingerstick j Perform a fingerstick with the lancing device 5 Fingerstick j Gently squeeze your finger to assist the flow of blood This helps you get a blood drop 6 51638_00048010155_C indb 46 6 11 13 3 57 PM ...

Page 53: ...ont edge of the yellow window of the test strip Do not put blood on top of the test strip 7 When the test strip has enough blood the Analyzing screen appears 8 9 The result appears on the display 51638_00048010155_C indb 47 6 11 13 3 57 PM ...

Page 54: ...48 10 Approximately 3 seconds later the detailed bG Result screen appears j Remove and discard the used test strip 51638_00048010155_C indb 48 6 11 13 3 57 PM ...

Page 55: ...trip error occurs remove and discard the used test strip and repeat the test with a new test strip Be careful not to put any fluids into the test strip slot The meter cannot be turned off when the following screens are displayed Match Code to Vial Apply Sample Analyzing bG Result When a test strip is in the meter the buttons are inactive The buttons become active when you remove the test strip or ...

Page 56: ...on is displayed insert a test strip into the meter From the Main Menu select Bolus Advice and press If bG Test is displayed instead of an actual blood glucose value then you can start a blood glucose test by selecting bG Test If an actual blood glucose value is displayed then you cannot start a blood glucose test using this process 51638_00048010155_C indb 50 6 11 13 3 57 PM ...

Page 57: ...plays the following information Test Time Meal Time Carbohydrates Health Event Active Insulin Displayed only if bolus advice is activated and data has recently been read from the pump Status Bar Blood Glucose Test Result Unit of Measure 51638_00048010155_C indb 51 6 11 13 3 57 PM ...

Page 58: ...iled bG Results Change Meal Time Carbs Health Events Optional The detailed bG Result screen allows you to view and to add information to a blood glucose test result 51638_00048010155_C indb 52 6 11 13 3 57 PM ...

Page 59: ...ated amount of Active Insulin To save the changes and exit the detailed bG Result screen j To return to the Main Menu select Menu j To proceed to the Bolus Advice screen select Bolus How to Add Information to a Blood Glucose Test Result Bolus Advice is not available if j The blood glucose test result is below the hypo warning limit j The detailed bG Result screen has been displayed for more than 5...

Page 60: ...fully used Active insulin appears only if bolus advice is activated Calculation of the amount of the active insulin is completed automatically by the meter If necessary the meter rounds the active insulin amount If the active insulin amount is calculated as zero then the value is displayed as 0 If active insulin data is not found then active insulin value is displayed as U If Bolus is selected the...

Page 61: ...t Date Status Bar Unit of Measure NOTE If the dosed test strip is removed from the meter before results or errors are displayed a blood glucose test result will not appear After approximately 3 seconds the meter displays the detailed bG Result screen see Section 2 4 Detailed Blood Glucose Test Results 51638_00048010155_C indb 55 6 11 13 3 57 PM ...

Page 62: ...e status bar descriptions with sample displays Green indicates the result is within the target range for the current time block Yellow indicates the result is below the target range for the current time block The result is not below the hypo warning limit Red with Hypo indicates the result is below the hypo warning limit 51638_00048010155_C indb 56 6 11 13 3 57 PM ...

Page 63: ...e result is above the target range for the current time block The result is not above the hyper warning limit Light blue with Hyper indicates the result is above the hyper warning limit 51638_00048010155_C indb 57 6 11 13 3 57 PM ...

Page 64: ... above the measurement range j Contact your healthcare professional NOTE Blood Glucose Warnings If the blood glucose test results are outside the hyper or hypo warning limits or outside the measurement range of the meter then a warning is displayed after the bG Test Result screen Select OK to acknowledge a warning and continue 51638_00048010155_C indb 58 6 11 13 3 57 PM ...

Page 65: ...s if you think the test strip container was uncapped for some time and repeat the blood glucose test 3 Was the test strip used immediately after it was removed from the test strip container Repeat the blood glucose test with a new test strip 4 Were the test strips stored in a cool dry place Repeat the blood glucose test with a properly stored test strip 5 Did you follow the directions Read Chapter...

Page 66: ...g 7 Are you still unsure of the problem Contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 After performing a control test and repeating a blood glucose test if your blood glucose test results still do not match the way you feel contact your healthcare professional immediately 51638_00048010155_C indb 60 6 11 13 3 57 PM ...

Page 67: ...ess sweating headache increased hunger dizziness pale skin color sudden change in mood or irritability fatigue difficulty concentrating clumsiness palpitations and or confusion WARNING If you are experiencing any of these symptoms test your blood glucose If your blood glucose test result is displayed as LO or HI contact your healthcare professional immediately The meter is designed to display bloo...

Page 68: ... must be fasting Take your meter to the healthcare professional s office and test yourself by fingerstick within five minutes of having blood drawn from your arm by a healthcare professional Keep in mind that the lab uses different technology than the meter and that blood glucose meters for self testing generally read somewhat lower than the lab result If you are fasting and you do a fingerstick t...

Page 69: ...ol Testing 3 1 Overview 64 3 2 Why Perform Control Tests 65 3 3 About the Control Solutions 66 3 4 Performing a Control Test 67 3 5 Understanding Control Test Results 73 51638_00048010155_C indb 63 6 11 13 3 57 PM ...

Page 70: ...test to ensure the accuracy of your blood glucose meter It is recommended you complete a control test prior to performing a blood glucose test for the first time NOTE Blood glucose and bG are interchangeable and mean the same thing 51638_00048010155_C indb 64 6 11 13 3 57 PM ...

Page 71: ...erform a control test when You open a new test strip box You left the test strip container open You want to check the meter and test strips Your test strips were stored in extreme temperatures humidity or both You dropped the meter Your test result does not match how you feel You want to check if you are performing the test correctly 51638_00048010155_C indb 65 6 11 13 3 57 PM ...

Page 72: ...date you opened the control solution bottle on the bottle label The solution is good for 3 months from that date or until the Use By date on the bottle label whichever comes first Do not use control solution that is past the Use By date The solution can stain clothing If you spill it wash your clothes with soap and water Close the bottle tightly after use 51638_00048010155_C indb 66 6 11 13 3 57 P...

Page 73: ...control solution Level 1 Level 2 or both The control level is printed on the bottle label Test Time Control Result Test Date Unit of Measure 3 4 Performing a Control Test The Control Result screen displays the following information 51638_00048010155_C indb 67 6 11 13 3 57 PM ...

Page 74: ...se By date on the test strip container Do not use test trips past the Use By date 3 The Apply Sample screen appears The test strip is ready for testing j Insert the golden end of a test strip into the meter in the direction of the arrow The meter turns on 51638_00048010155_C indb 68 6 11 13 3 57 PM ...

Page 75: ...n a flat surface like a table j Select the control solution to test You will enter the level later in the test 6 j Remove the control bottle cap Wipe the tip of the bottle with a tissue 51638_00048010155_C indb 69 6 11 13 3 57 PM ...

Page 76: ...le tightly 9 The control result appears on the display j Select Level to display the control solution level pop up menu 7 j Squeeze the bottle until a tiny drop forms at the tip j Touch the drop to the front edge of the yellow window of the test strip Do not put control solution on top of the test strip 51638_00048010155_C indb 70 6 11 13 3 57 PM ...

Page 77: ... and press 11 j Remove and discard the test strip j For information on understanding control test results proceed to the next section or select Menu to save this result and display the Main Menu screen 51638_00048010155_C indb 71 6 11 13 3 57 PM ...

Page 78: ...long with No Entry and then the Detailed Control Result screen is displayed When the Control Level screen is displayed and you turn off the meter or if the meter auto powers off without selecting a control solution level then No Entry is chosen The meter stores the control test result along with No Entry Other ways to start a control test From the Main Menu select bG Test Insert a test strip into ...

Page 79: ...to save result and display Main Menu screen Test Date Control Solution Level Result Within range or Out of range 3 5 Understanding Control Test Results The detailed Control Result screen displays the following information 51638_00048010155_C indb 73 6 11 13 3 57 PM ...

Page 80: ...e level selected the meter displays whether the result is within or outside of the acceptable range Example Range mg dL Level 1 25 55 Level 2 255 345 j When the control test result is inside the range on the test strip container the test strips and the meter are working properly If the control test result is within the acceptable range Within range appears on the detailed Control Result screen Exa...

Page 81: ...ange Out of range appears on the detailed Control Result screen If HI is displayed the control test result may be above the measurement range If LO is displayed the control test result may be below the measurement range 51638_00048010155_C indb 75 6 11 13 3 58 PM ...

Page 82: ...76 If the meter stored No Entry for the control solution level then appears with no indication of in or out of range 51638_00048010155_C indb 76 6 11 13 3 58 PM ...

Page 83: ...use Wipe the tip of the bottle with a tissue Repeat the control test with a new test strip and a fresh drop of control solution 3 Were the caps on the test strip container and the control solution bottle always closed tightly Replace the test strips or control solutions if you think either was uncapped for some time and repeat the control test 4 Was the test strip used immediately after it was rem...

Page 84: ...t 1 800 688 4578 7 Did you choose the correct control solution level either 1 or 2 when you performed the control test If you chose the wrong control solution level you can still compare the control result to the range printed on the test strip container 8 Are you still unsure of the problem Contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 51638_00048010155_C indb 78 6 11 13 3 58 P...

Page 85: ...anaging Your Data 4 1 Overview 80 4 2 Viewing or Modifying Your Data 83 4 3 Adding New Data 92 4 4 Reporting Your Data 95 4 5 Downloading Your Data to a Computer 133 51638_00048010155_C indb 79 6 11 13 3 58 PM ...

Page 86: ...y record you are able to change or add to its attributes The meter generates reports such as blood glucose averages with standard deviations for the time period you select e g the past 7 days or the past 30 days Graphs can be a good way to view your blood glucose test results The meter can display a line graph to depict blood glucose record trends a graph showing result ranges for a standard day o...

Page 87: ...ewest to the oldest It is very important to have the correct time and date set Having the correct time and date setting helps ensure accurate interpretation of blood glucose test results by you and your healthcare professional Each diary record can contain Date and time Blood glucose test result Meal time events Carbs Health event Bolus type Bolus amount You can display filtered diary data in grap...

Page 88: ...ou replace the batteries For more information on changing the batteries see Chapter 8 Maintenance Once 1 000 records are in the diary memory adding a new record causes the oldest diary record to be deleted The control results are stored in memory but cannot be reviewed on the meter Before reviewing diary records or control results with software the stored diary records must first be downloaded to ...

Page 89: ...Date of Record s Time of Blood Glucose Test Blood Glucose Test Icon Meal Time Icon Carbs Icon Unit of Measure Blood Glucose Test Result Appropriate Bolus Icon Select View Change meter display between blood glucose bolus and carbs views Health Event Icon 51638_00048010155_C indb 83 6 11 13 3 58 PM ...

Page 90: ...y occurred with the most recent record shown on top For the blood glucose test result HI is displayed if the test result is above the measurement range LO is displayed if the test result is below the measurement range The blood glucose test result is blank if a blood glucose test value does not exist 51638_00048010155_C indb 84 6 11 13 3 58 PM ...

Page 91: ...ord regarding carbs Health Event Icon is displayed when information exists for this diary record regarding health events Standard Bolus Not Confirmed Delivery has not been confirmed by the pump Standard Bolus Confirmed Delivery has been confirmed by the pump Multiwave Bolus Not Confirmed Delivery has not been confirmed by the pump Multiwave Bolus Confirmed Delivery has been confirmed by the pump E...

Page 92: ...escription Extended Bolus Confirmed Delivery has been confirmed by the pump Manual Pump Delivery has not been confirmed by the pump Pen Syringe Bolus Pump does not deliver bolus 51638_00048010155_C indb 86 6 11 13 3 58 PM ...

Page 93: ...rd with its attributes blood glucose value meal time carbs health event and bolus Main Menu My Data View Data 1 j From the Main Menu select My Data and press 2 j Select View Data and press 51638_00048010155_C indb 87 6 11 13 3 58 PM ...

Page 94: ...her view press a pop up menu appears Select the view you want and press Press x or z to view other records the screen scrolls if there are additional records To view or modify a record s details select the record and press Blood Glucose View Bolus View Carbs View 51638_00048010155_C indb 88 6 11 13 3 58 PM ...

Page 95: ...o return to the previous screen select Back or To modify a diary record select Modify and continue to the next step 5 j Select the entry field to modify and press j Make the change in the entry field and press j Modify other fields as needed 51638_00048010155_C indb 89 6 11 13 3 58 PM ...

Page 96: ...90 To save the changes and return to the View Detail screen select Save NOTE To cancel changes or return to the View Detail screen select Cancel 51638_00048010155_C indb 90 6 11 13 3 58 PM ...

Page 97: ...d if the Bolus Bolus type is confirmed standard extended or multiwave Bolus Blood glucose test result was below the hypo warning limit Meal Time Record has no blood glucose value Meal Time Carbs Health Event and Bolus Record has been used for bolus advice 51638_00048010155_C indb 91 6 11 13 3 58 PM ...

Page 98: ... The Add Data screen displays the following information 4 3 Adding New Data Time Entry Field Date Entry Field Carbs Entry Field Health Entry Field Bolus Entry Field Save Appears once data has been entered to an entry field 51638_00048010155_C indb 92 6 11 13 3 58 PM ...

Page 99: ...y Data Add Data 1 j From the Main Menu select My Data and press 2 3 j Select Add Data and press j Select an entry field and press j Make addition in the entry field and press 51638_00048010155_C indb 93 6 11 13 3 58 PM ...

Page 100: ... current time You can change the date and time when adding a diary record although the date and time cannot be set in the future Before a diary record can be saved data must be entered not including date and time Save is not displayed above until data has been entered To cancel changes and return to the My Data screen select Cancel 51638_00048010155_C indb 94 6 11 13 3 58 PM ...

Page 101: ... Meal Times Blood Glucose Standard Deviation Calculated for the time range Number of Tests Used to calculate the averages and standard deviations Blood Glucose Average Calculated for the time range 51638_00048010155_C indb 95 6 11 13 3 58 PM ...

Page 102: ...d the blood glucose average A low standard deviation means the blood glucose test results are tightly clustered around the blood glucose average a high standard deviation means the blood glucose test results are widely scattered around the blood glucose average Calculations do not include corrupt results control results or HI and LO results 51638_00048010155_C indb 96 6 11 13 3 58 PM ...

Page 103: ...se averages and standard deviations for the time range you choose 7 14 30 60 or 90 days Main Menu My Data Reports bG Averages 1 j From the Main Menu select My Data and press 2 j Select Reports and press 3 j Select bG Averages and press 51638_00048010155_C indb 97 6 11 13 3 58 PM ...

Page 104: ... To display blood glucose averages for another time range last 7 14 30 60 or 90 days press either or to scroll the screen until you reach the time range you need To return to the Reports screen select Back 51638_00048010155_C indb 98 6 11 13 3 58 PM ...

Page 105: ...ose record trends for the time range you choose last 8 hours 24 hours 48 hours or 7 days Main Menu My Data Reports Trend 1 j From the Main Menu select My Data and press 2 j Select Reports and press 3 j Select Trend and press 51638_00048010155_C indb 99 6 11 13 3 58 PM ...

Page 106: ...easure Carbs Icon Arrow Indicates blood glucose data extends beyond screen Each Blood Glucose Value Connected with lines Warning Limit Hypo Level Red horizontal line Bolus Value Blue bar height shown is in relation to the bolus insulin amount Carb Value Dark orange bar height shown is in relation to the carbs amount Time Change Icon Only shown when meter time has been changed for this data 51638_0...

Page 107: ...irectly on the pump go to My Data on the meter to receive the bolus information automatically Do this before your next blood glucose test Replace the batteries when the Low Battery icon appears This maintains the communication between meter and pump 51638_00048010155_C indb 101 6 11 13 3 58 PM ...

Page 108: ... Maximum Bolus Amount Indicator values available on the meter are 1 5 15 30 and 60 U The indicator displayed is based on the single largest bolus insulin amount delivered for the time range chosen For example if the largest bolus delivered during the chosen time range is 8 U then the meter will scale the upper graph to be between 0 and 15 U On the right side of the graph the Maximum Carbs Amount I...

Page 109: ...for another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Trend Graph 3 j Press to display the Table proceed to the next section for more information To return to the Reports screen selec...

Page 110: ...104 NOTE The meter saves the current settings time range meal time and graph view when you select Back or when the meter powers off 51638_00048010155_C indb 104 6 11 13 3 58 PM ...

Page 111: ...f Records Blood Glucose Icon with Blood Glucose Unit of Measure Time Change Icon Only shown when meter time has been changed for this data Carbs Icon with Carbs Unit of Measure Bolus Icon with the Bolus Unit of Measure 51638_00048010155_C indb 105 6 11 13 3 58 PM ...

Page 112: ... the meter clock has been changed All times in the trend table show the data relative to the current meter time For example 1 You take a bG test and the value is stored in the meter at 9 00 am 2 The meter time is changed ahead 1 hour 3 The bG data on the trend table is shown at 10 00 am Trend table data is cleared if bolus advice data is cleared For a given record if the blood glucose value carb v...

Page 113: ...op of screen Press either or until you reach the time range you need 3 j To display a trend table for another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Trend Table 51638_00048010155_C...

Page 114: ...s section for more information To return to the Reports screen select Back NOTE The meter saves the current settings time range meal time and table view when you select Back or when the meter powers off 51638_00048010155_C indb 108 6 11 13 3 58 PM ...

Page 115: ...ests and standard deviations within predetermined time blocks for the time range you choose last 7 14 30 60 or 90 days Main Menu My Data Reports Standard Day 1 j From the Main Menu select My Data and press 2 j Select Reports and press 3 j Select Standard Day and press 51638_00048010155_C indb 109 6 11 13 3 58 PM ...

Page 116: ...Block X in center of box indicates the average of all blood glucose test results for the selected criteria The top of the box indicates 1 standard deviation above the average and the bottom of the box indicates 1 standard deviation below the average The box is not displayed if there are not enough data to determine standard deviation The top of box is open if the standard deviation is off the top ...

Page 117: ...t available to display the standard day graph the No Data Available screen is displayed The standard day graph does not include corrupt results control results HI values or LO values 51638_00048010155_C indb 111 6 11 13 3 58 PM ...

Page 118: ...another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Standard Day Graph 3 j Press to display the Table proceed to the next section for more information To return to the Reports screen se...

Page 119: ...113 4 NOTE The meter saves the current settings time range meal time and graph view when you select Back or when the meter powers off 51638_00048010155_C indb 113 6 11 13 3 58 PM ...

Page 120: ...114 Standard Day Table Screen Time Range Meal Time Selection Time Block Blood Glucose Average Standard Deviation SD Number of Tests 51638_00048010155_C indb 114 6 11 13 3 58 PM ...

Page 121: ...reen is displayed Standard day table calculations do not include corrupt results control results or HI and LO results For a standard deviation to be displayed for a given time block there must have been two or more tests recorded during the time block 51638_00048010155_C indb 115 6 11 13 3 58 PM ...

Page 122: ...ntil you reach the time range you need 3 j To display a standard day table for another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Standard Day Table 51638_00048010155_C indb 116 6 11 1...

Page 123: ...us section for more information To return to the Reports screen select Back NOTE The meter saves the current settings time range meal time and table view when you select Back or when the meter powers off 51638_00048010155_C indb 117 6 11 13 3 58 PM ...

Page 124: ...f tests and standard deviations for each day of the week for the time range you choose last 7 14 30 60 or 90 days Main Menu My Data Reports Standard Week 1 j From the Main Menu select My Data and press 2 j Select Reports and press 3 j Select Standard Week and press 51638_00048010155_C indb 118 6 11 13 3 58 PM ...

Page 125: ...e test results for the selected criteria The top of the box indicates 1 standard deviation above the average and the bottom of the box indicates 1 standard deviation below the average The box is not displayed if there are not enough data to determine standard deviation The top of box is open if the standard deviation is off the top of the graph Box and X are not displayed for a day if no data are ...

Page 126: ...available to display the standard week graph the No Data Available screen is displayed The standard week graph does not include corrupt results control results HI values or LO values 51638_00048010155_C indb 120 6 11 13 3 58 PM ...

Page 127: ... another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Standard Week Graph 3 j Press to display the Table proceed to the next section for more information To return to the Reports screen ...

Page 128: ...122 NOTE The meter saves the current settings time range meal time and graph view when you select Back or when the meter powers off 51638_00048010155_C indb 122 6 11 13 3 58 PM ...

Page 129: ...ilable to display the standard week table the No Data Available screen is displayed Standard week table calculations do not include corrupt results control results or HI and LO results For a standard deviation to be displayed for a given day of the week there must have been two or more tests recorded during the day 51638_00048010155_C indb 123 6 11 13 3 58 PM ...

Page 130: ... reach the time range you need 3 j To display a standard week graph for another meal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need Standard Week Table 51638_00048010155_C indb 124 6 11 13 3 58...

Page 131: ...us section for more information To return to the Reports screen select Back NOTE The meter saves the current settings time range meal time and table view when you select Back or when the meter powers off 51638_00048010155_C indb 125 6 11 13 3 58 PM ...

Page 132: ...ucose records as Above Within Below and Hypo for the time range you choose last 7 14 30 60 or 90 days Main Menu My Data Reports Target 1 j From the Main Menu select My Data and press 2 j Select Reports and press 3 j Select Target and press 51638_00048010155_C indb 126 6 11 13 3 58 PM ...

Page 133: ...art Represents the percentages for the blood glucose test result categories NOTE If data are not available to display the target graph the No Data Available screen is displayed The target graph does not include corrupt results control results or HI and LO results 51638_00048010155_C indb 127 6 11 13 3 58 PM ...

Page 134: ...al time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need 3 j Press to display the Table proceed to the next section for more information To return to the Reports screen select Back Target Graph 51638_...

Page 135: ...129 4 NOTE The meter saves the current settings time range meal time and graph view when you select Back or when the meter powers off 51638_00048010155_C indb 129 6 11 13 3 58 PM ...

Page 136: ...election Percentage of Occurrence NOTE If results or data are not available for the selected time period and meal time the No Data Available screen is displayed The target table does not include corrupt results control results or HI and LO results 51638_00048010155_C indb 130 6 11 13 3 58 PM ...

Page 137: ...eal time selection Overall Pre Meal Post Meal Bedtime or Other press either x or z to highlight the meal time selection field immediately below the time range which is at the top of the screen Press either or until you reach the meal time selection you need 3 j Press to display the Target Graph see previous section for more information To return to the Reports screen select Back Target Table 51638...

Page 138: ...132 NOTE The meter saves the current settings time range meal time and table view when you select Back or when the meter powers off 51638_00048010155_C indb 132 6 11 13 3 58 PM ...

Page 139: ...l the software according to the instructions j Connect the computer cable according to the instructions 2 j Run the software program and follow the instructions about how to download information Ensure the software is ready to accept data from the meter 3 j From the Main Menu select My Data and press 51638_00048010155_C indb 133 6 11 13 3 58 PM ...

Page 140: ...window on the top of the meter j Locate the IR window on the computer s infrared cable j Point the two IR windows toward each other They should be 1 to 4 inches apart 6 j Follow the prompts on your computer software to start the data transfer 51638_00048010155_C indb 134 6 11 13 3 58 PM ...

Page 141: ...ayed for 3 seconds and then the meter turns off NOTE If the data did not transfer successfully turn off the meter turn the meter back on and try again If you still have problems contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 51638_00048010155_C indb 135 6 11 13 3 58 PM ...

Page 142: ...136 51638_00048010155_C indb 136 6 11 13 3 58 PM ...

Page 143: ...me Blocks Health Events Advice Options Bolus Advice Set Up 161 5 7 Setting Warning Limits Hyper Hypo 170 5 8 Turning Key Lock On or Off 173 5 9 Setting the Language 176 5 10 Setting Units Carbs 179 5 11 Turning Bluetooth Wireless Technology On or Off 182 5 12 Pairing the Meter and Pump 184 5 13 Setting the Beeper Vibrate Key Sound 185 5 14 Setting the Time Format Time Date 188 5 15 Setting Time Bl...

Page 144: ...tings are selected Settings Important Information When editing a setting any unsaved changes are discarded if the meter turns off or if a test strip is inserted into the meter It is important to ensure that the time and date are correctly set in order to create accurate diary records If you change the pump time and date the meter time and date will automatically synchronize to match the pump NOTE ...

Page 145: ...hedule snooze the reminder by pressing The snooze time for After High bG is 15 minutes The snooze time for After Low bG and After Meal is 5 minutes If not dismissed or snoozed the reminder is displayed a total of four times at intervals of 2 minutes after which the meter dismisses the reminder When you perform a blood glucose test the meter dismisses any bG test reminders which are pending within ...

Page 146: ...in Menu Settings Reminders bG Test Reminders 1 j From the Main Menu select Settings and press 2 3 j Select Reminders and press j Select bG Test Reminders and press 51638_00048010155_C indb 140 6 11 13 3 58 PM ...

Page 147: ...Off and press To Change the bG Threshold j Select the bG Threshold entry field and press j Set the bG Threshold level and press To Change the Remind After Time j Select the Remind After entry field and press j Set the amount of time after a high blood glucose test result you want to be reminded to retest your blood glucose and press To save the changes and return to the bG Test Reminders screen se...

Page 148: ...n or Off and press To Change the Snack Size j Select the Snack Size entry field and press j Set the Snack Size amount and press To Change the Remind After Time j Select the Remind After entry field and press To Change the Remind After Time j Select the Remind After entry field and press j Set the amount of time after a low blood glucose test result you want to be reminded to retest your blood gluc...

Page 149: ...s hour and M is minute When the meter is displaying the Remind After Meal screen for the first time if bolus advice has not been set up the default for Snack Size is no entry g If bolus advice has been set up the default value is the value set for the Snack Size on the Advice Options screen To cancel changes or to return to the previous screen select Cancel If you changed the Snack Size the After ...

Page 150: ...he reminder is displayed when the meter powers down Alarm Clock bG Test Dismiss the reminder by pressing Reschedule snooze the reminder for 15 minutes by pressing Alarm Clock Other Dismiss the reminder either by pressing or by inserting a test strip Reschedule snooze the reminder for 15 minutes by pressing If not dismissed or snoozed the reminder is displayed a total of four times at intervals of ...

Page 151: ...45 5 Main Menu Settings Reminders Alarm Clock 1 j From the Main Menu select Settings and press 2 j Select Reminders and press 3 j Select Alarm Clock and press 51638_00048010155_C indb 145 6 11 13 3 58 PM ...

Page 152: ...d press j Repeat the above steps to turn off additional reminders To save the changes and return to the Reminders screen select Save NOTE To cancel changes or return to the Reminders screen select Cancel Time for the Alarm Clock reminders can be set in 15 minute increments where HH is hour MM is minutes and with am or pm for the 12 hour format If you tested within 30 minutes of a bG Test Reminder ...

Page 153: ...oing reminder for an infusion set change for the interval you choose 1 day 2 days or 3 days Date Reminders Important Information Displayed when you turn on the meter and a test strip has not been inserted Dismiss the reminder either by pressing or by inserting a test strip For more information see Chapter 6 Icons Reminders Warnings and Errors 51638_00048010155_C indb 147 6 11 13 3 58 PM ...

Page 154: ... Main Menu Settings Reminders Date Reminders 1 j From the Main Menu select Settings and press 2 3 j Select Reminders and press j Select Date Reminders and press 51638_00048010155_C indb 148 6 11 13 3 58 PM ...

Page 155: ...he Reminder entry field and press j Select On or Off and press To Set the Date j Select the Date entry field and press j Set the Day and press j Set the Month and press j Set the Year and press To Set the Time Optional j Select the Time entry field and press j Set the Time and press To save the changes and return to the Date Reminders screen select Save 51638_00048010155_C indb 149 6 11 13 3 58 PM...

Page 156: ...To Turn the Infusion Set Change Reminder On or Off j Select the Reminder entry field and press j Select On or Off and press To Set the Interval j Select the Interval entry field and press j Select the Interval 1 day 2 days or 3 days and press To Set the Time Optional j Select the Time entry field and press j Set the Time and press To save the changes and return to the Date Reminders screen select ...

Page 157: ...es or to return to the Date Reminders screen select Cancel Time for the Dr Visit Reminder and the Lab Test Reminder can be set in 15 minute increments where HH is hour MM is minutes and with am or pm for the 12 hour format Date Reminders do not automatically turn on the meter and display the Reminder Date Reminders only occur when you power on the meter on the appropriate date 51638_00048010155_C ...

Page 158: ... the Getting Started Guide before continuing Prior to setting up time blocks for bolus advice it is recommended that you decide how many time blocks you need and also determine the start end times Talk to your healthcare professional about arranging your time blocks to help best manage your diabetes For each time block you can set up different blood glucose target ranges carb ratios and insulin se...

Page 159: ... Insulin Units Time Block End Time Target Range Upper Limit Value Carb Ratio Number of Carbs Insulin Sensitivity Number of Insulin Units Scroll Bar Insulin Sensitivity Change in Glucose Level Time Blocks Bolus Advice Screen scroll down 51638_00048010155_C indb 153 6 11 13 3 58 PM ...

Page 160: ...Menu select Settings and press j If you do NOT want to set up bolus advice select No to return to the Settings screen j To set up bolus advice select Yes and continue to the next step j Select Bolus Advice and press 51638_00048010155_C indb 154 6 11 13 3 58 PM ...

Page 161: ...lect Next 5 To Change Time Blocks j Select a time block to edit and press scroll down To Change the End Time j Select the End Time entry field and press j Set the End Time and press 51638_00048010155_C indb 155 6 11 13 3 58 PM ...

Page 162: ...mount of Carbs and press j Set the amount of Carbs covered by the number of Insulin Units and press To Change the Insulin Sensitivity j Select the entry field for the number of Insulin Units and press j Set the number of Insulin Units and press j Select the entry field for the Insulin Sensitivity level and press j Set the Insulin Sensitivity level and press j Select Save 6 The carb ratio and insul...

Page 163: ...and press j Select the End Time entry field and press j Set the End Time of the selected time block and press This will be the start time of the added time block j To save the changes and return to the Time Blocks screen select Save j Add another Time Block or proceed to Step 8 To Remove a Time Block j Select the Time Block you want to remove and press 51638_00048010155_C indb 157 6 11 13 3 58 PM ...

Page 164: ...ld of the Health Event to be changed and press j Set the percentage and press j Repeat the previous steps to change another Health Event j To continue select Next To Change the Meal Rise j Select the Meal Rise entry field and press j Set the Meal Rise limit and press To Change the Snack Size j Select the Snack Size entry field and press j Set the Snack Size amount and press To Change the Acting Ti...

Page 165: ...ack j Set the Acting Time duration and press To Change the Offset Time j Select the Offset Time entry field and press j Set the Offset Time duration and press To save the changes and exit select Save j Select OK 51638_00048010155_C indb 159 6 11 13 3 58 PM ...

Page 166: ...ular meal with the expected meal rise In this case in contrast to regular meals an increase in your blood glucose test result is not tolerated since the meal rise factor is not triggered for bolus advice calculations Acting Time The acting time is the period of time from the start of the meal rise or the delivery of a correction bolus until your blood glucose level is expected to return to the tar...

Page 167: ...ent percentages Changing advice options meal rise snack size acting time offset time Before continuing it is recommended that you review the Getting Started Guide determine how many time blocks you need and determine the start end times for each time block To help best manage your diabetes talk to your healthcare professional about arranging your time blocks including setting up different blood gl...

Page 168: ...olus Advice is Set Up Main Menu Settings Bolus Advice Time Blocks 1 2 j From the Main Menu select Settings and press 3 j Select Bolus Advice and press j Select Time Blocks and press 51638_00048010155_C indb 162 6 11 13 3 58 PM ...

Page 169: ...nd Time of the selected Time Block and press This will be the start time of the added time block j To save the changes and return to the Time Blocks screen select Save j Proceed to To Change the Time Blocks To Remove a Time Block j Select the Time Block you want to remove and press j Select the End Time entry field and press j Set the End Time to match the start time of the Time Block and press 51...

Page 170: ... entry field for the upper value of the Target Range and press j Set the value and press To Change the Carb Ratio j Select the entry field for the number of Insulin Units and press j Set the number of Insulin Units and press j Select the entry field for the amount of Carbs and press j Set the amount of Carbs covered by the selected units of insulin and press To Change the Insulin Sensitivity j Sel...

Page 171: ...in Sensitivity level and press j Select Save 6 j To change another time block select the time block and press Return to Step 5 j To return to the Bolus Advice screen select Back 51638_00048010155_C indb 165 6 11 13 3 58 PM ...

Page 172: ...lus Advice is Set Up Main Menu Settings Bolus Advice Health Events 1 2 j From the Main Menu select Settings and press 3 j Select Bolus Advice and press j Select Health Events and press 51638_00048010155_C indb 166 6 11 13 3 58 PM ...

Page 173: ...y field of the Health Event to be changed and press j Set the percentage and press j Repeat the previous steps to change other Health Events To save the changes and return to the Bolus Advice screen select Save 51638_00048010155_C indb 167 6 11 13 3 58 PM ...

Page 174: ...ns Bolus Advice is Set Up Main Menu Settings Bolus Advice Advice Options 1 2 j From the Main Menu select Settings and press j Select Bolus Advice and press j Select Advice Options and press 51638_00048010155_C indb 168 6 11 13 3 58 PM ...

Page 175: ...ime entry field and press j Set the Acting Time duration and press To Change the Offset Time j Select the Offset Time entry field and press j Set the Offset Time duration and press To save the changes select Save 4 If you did not change the Snack Size the meter returns to the Bolus Advice screen If you changed the Snack Size the meter displays the Advice Options screen j Select OK to return to the...

Page 176: ...ove Hyper Warning Limit message Consider checking for ketones bG and insulin regularly If your test result is below the hypo warning limit the meter displays the Below Hypo Warning Limit message Eat fast carbs of at least number of carbs Retest bG 1 The meter displays a recommended amount of fast carbohydrates WARNING This function is no substitute for hyperglycemia or hypoglycemia training by you...

Page 177: ...171 5 Main Menu Settings Meter Warning Limits 1 2 j From the Main Menu select Settings and press j Select Meter and press 3 j Select Warning Limits and press 51638_00048010155_C indb 171 6 11 13 3 58 PM ...

Page 178: ...et the Hyper upper blood glucose level and press To Change the Hypo Blood Glucose Level j Select the Hypo entry field and press j Set the Hypo lower blood glucose level and press To save the changes and return to the Meter Menu screen select Save 51638_00048010155_C indb 172 6 11 13 3 58 PM ...

Page 179: ...f The key lock feature allows you to lock all of the buttons on the meter except for the power on off button This serves as a safety measure against unintentional activation of meter functions 51638_00048010155_C indb 173 6 11 13 3 58 PM ...

Page 180: ...174 Main Menu Settings Meter Key Lock 1 2 j From the Main Menu select Settings and press j Select Meter and press 3 j Select Key Lock and press 51638_00048010155_C indb 174 6 11 13 3 58 PM ...

Page 181: ...unlocked for the current session When the meter is turned on again the buttons are locked Key Lock Important Information j When the buttons are locked you can still turn the meter on and off You can also adjust the backlight j The buttons are unlocked when A test strip is inserted into the meter The meter is turned on and a pump error or a pump warning occurs For these occurrences the buttons rema...

Page 182: ...176 5 9 Setting the Language You can select a language from the predefined list 51638_00048010155_C indb 176 6 11 13 3 58 PM ...

Page 183: ...177 5 Main Menu Settings Meter Language 1 2 j From the Main Menu select Settings and press j Select Meter and press 3 j Select Language and press 51638_00048010155_C indb 177 6 11 13 3 58 PM ...

Page 184: ...178 4 j Press to display the Language options j Select the desired Language and press To save the change and return to the Meter Menu screen select Save 51638_00048010155_C indb 178 6 11 13 3 58 PM ...

Page 185: ... Carbs You can set up the meter for different carbohydrate carbs units Grams BE KE or CC Once the Carbs Units are set and bolus advice is activated the Carbs Units cannot be changed 51638_00048010155_C indb 179 6 11 13 3 58 PM ...

Page 186: ...180 Main Menu Settings Meter Units 1 2 j From the Main Menu select Settings and press j Select Meter and press 3 j Select Units and press 51638_00048010155_C indb 180 6 11 13 3 58 PM ...

Page 187: ...een select Save NOTE For more information on the units for carbohydrates and carbohydrate equivalents see Appendix B Carb Units NOTE Once this is set and bolus advice is activated this unit cannot be changed If this unit needs to be changed contact the ACCU CHEK Customer Care Service Center at 1 800 688 4578 51638_00048010155_C indb 181 6 11 13 3 58 PM ...

Page 188: ...tooth Wireless Technology On or Off Main Menu Settings Meter Bluetooth 1 2 j From the Main Menu select Settings and press j Select Meter and press 3 j Select Bluetooth and press 51638_00048010155_C indb 182 6 11 13 3 58 PM ...

Page 189: ...th wireless technology either On or Off press and hold until the Bluetooth wireless technology icon changes Release To save the change and return to the Meter Menu screen select Back 51638_00048010155_C indb 183 6 11 13 3 58 PM ...

Page 190: ...184 5 12 Pairing the Meter and Pump For complete pairing instructions see the Advanced Owner s Booklet 51638_00048010155_C indb 184 6 11 13 3 58 PM ...

Page 191: ...me a button is pressed Even when the beeper is turned off the meter still beeps when an error message occurs When in the low battery condition the meter uses the medium beeper level if the beeper level is set to high and disables vibrate In the low battery condition the main menu screen will continue to display the icons for vibrate and beeper unless you have set them to Off After the batteries ar...

Page 192: ...nd press 3 To Change the Beeper Sound Level j Select the Beeper entry field and press j Select the Beeper sound level Off Low Medium or High and press To Turn the Vibrate On or Off j Select the Vibrate entry field and press j Select the Vibrate mode On or Off and press 51638_00048010155_C indb 186 6 11 13 3 58 PM ...

Page 193: ...e Key Sound j Select the Key Sound entry field and press j Select the Key Sound mode On or Off and press To save the changes and return to the Settings Menu screen select Save 51638_00048010155_C indb 187 6 11 13 3 58 PM ...

Page 194: ...ct the Trend Graph and the Trend Table see Reporting Your Data Trends in Section 4 4 Reporting Your Data For 12 hour time format time is displayed as HH MM A P example 3 53 pm and for 24 hour time format time is displayed as HH MM example 15 53 where H is hour and M is minute The date format is displayed as DD MMM YY example 02 Feb 08 where D is day M is month and Y is year 51638_00048010155_C ind...

Page 195: ...j From the Main Menu select Settings and press j Select Time Date and press 3 To Change the Time Format j Select the Time Format entry field and press j Select 12 hr or 24 hr Time Format and press 51638_00048010155_C indb 189 6 11 13 3 58 PM ...

Page 196: ...d press j If Time Format is 12 hr select am or pm and press To Change the Date j Select the Date entry field and press j Set the Day and press j Set the Month and press j Set the Year and press To save the changes and return to the Settings Menu screen select Save 51638_00048010155_C indb 190 6 11 13 3 58 PM ...

Page 197: ... suggested that you review the Getting Started Guide before continuing Prior to setting up time blocks it is recommended that you determine how many time blocks you need and also determine the start end times Talk to your healthcare professional about arranging your time blocks in order to help best manage your diabetes Target Range Lower Value Time Block End Time Target Range Upper Value 51638_00...

Page 198: ...oes not appear if bolus advice has been set up j Select Time Blocks and press Change End Time Target Range Lower Value and or Target Range Upper Value Main Menu Settings Time Blocks 3 j Select the time block to edit and press 51638_00048010155_C indb 192 6 11 13 3 58 PM ...

Page 199: ...f the Target Range and press j Set the value and press j Select the entry field for the upper value of the Target Range and press j Set the value and press To save the changes and return to the Time Blocks screen select Save 5 j Repeat Steps 3 and 4 to change another time block Otherwise select Back to return to the Settings screen 51638_00048010155_C indb 193 6 11 13 3 58 PM ...

Page 200: ...hen you set the end time the meter sets this end time as the start time for the next time block The end time can be set in 30 minute increments To cancel changes press 51638_00048010155_C indb 194 6 11 13 3 58 PM ...

Page 201: ...ttings and press Time Blocks does not appear if bolus advice has been set up j Select Time Blocks and press Add a Time Block Main Menu Settings Time Blocks 3 j Select the last time block and press 51638_00048010155_C indb 195 6 11 13 3 58 PM ...

Page 202: ... the start time of the added time block To save the changes and return to the Time Blocks screen select Save 5 j Update the End Times and Target Ranges for all time blocks as needed See Change End Time Target Range Lower Value and or Target Range Upper Value in this section 51638_00048010155_C indb 196 6 11 13 3 58 PM ...

Page 203: ...nd press Time Blocks does not appear if bolus advice has been set up j Select Time Blocks and press Remove a Time Block Main Menu Settings Time Blocks 3 j Select the Time Block you want to remove and press 51638_00048010155_C indb 197 6 11 13 3 58 PM ...

Page 204: ... Block and press To save the changes and return to the Time Blocks screen select Save 5 j Update the End Times and Target Ranges for the remaining time blocks as needed See Change End Time Target Range Lower Value and or Target Range Upper Value in this section 51638_00048010155_C indb 198 6 11 13 3 58 PM ...

Page 205: ...the meter display under different lighting conditions You can adjust the backlight level by pressing the backlight button on the front of the meter The backlight adjusts from low to medium to high and back to low again Backlight Button Press to adjust the backlight level 51638_00048010155_C indb 199 6 11 13 3 58 PM ...

Page 206: ...ht setting when you press a button insert a test strip or when the meter displays the bG Results screen When in the low battery condition the meter uses the medium backlight level if the backlight level is set to high After the batteries are replaced with new ones the meter again allows the high backlight setting The backlight button is disabled during a blood glucose test a control test and when ...

Page 207: ...Warnings and Errors 6 1 Overview 202 6 2 List of Icons 203 6 3 Confirming a Reminder Warning or Error 205 6 4 List of Reminders 206 6 5 List of Warnings 216 6 6 List of Errors 222 51638_00048010155_C indb 201 6 11 13 3 58 PM ...

Page 208: ...apter provides you with detailed listings of all the icons reminders warnings and errors included in the meter NOTE Blood glucose and bG are interchangeable and mean the same thing 51638_00048010155_C indb 202 6 11 13 3 58 PM ...

Page 209: ...less Technology Enabled Bolus Advice Bolus Advice Settings Carbs 6 2 List of Icons The icons and icon names in the meter are Icon Name Icon Control Test Date Download Data Transfer Error Extended Bolus Confirmed Extended Bolus Not Confirmed Health Low Battery Meal Time Meter 51638_00048010155_C indb 203 6 11 13 3 58 PM ...

Page 210: ...y Data Pen Syringe Bolus Pump Reminder Reminders Settings Reports Settings Icon Name Icon Sound Vibrate Settings Standard Bolus Confirmed Standard Bolus Not Confirmed Time Time Block Settings Time Change Time Date Settings Vibrate View Data Warning 51638_00048010155_C indb 204 6 11 13 3 58 PM ...

Page 211: ...ngs press Some error messages require a different confirmation such as Retest with new Strip or Replace batteries now To place some reminders in the snooze mode press See the following sections for more details on a specific reminder warning or error 51638_00048010155_C indb 205 6 11 13 3 58 PM ...

Page 212: ...inder This is not available for all reminders NOTE The meter beeps when it displays any reminder if the beeper setting is on The meter vibrates when it displays any of the following reminders if the vibrate setting is on After Meal Retest bG Test High bG Retest Low bG Retest and Other 51638_00048010155_C indb 206 6 11 13 3 58 PM ...

Page 213: ...Time After Meal Retest Carbs entry higher than Snack Size setting Retest Snooze Dismiss 5 minutes bG Test It is time for your scheduled bG test Snooze Dismiss 15 minutes Dr Visit Today If the Dr Visit time has been set You have a Dr Appointment today at Settings Dr Visit Time 1 Or if the Dr Visit time has not been set You have a Dr Appointment today Dismiss 51638_00048010155_C indb 207 6 11 13 3 5...

Page 214: ...morrow at Settings Dr Visit Time Or if the Dr Visit time has not been set You have a Dr Appointment tomorrow Dismiss High bG Retest High bG Result on last test Retest Snooze Dismiss 15 minutes Infusion Set Change It is time to change your Infusion Set Snooze Dismiss Displayed the next time the meter is powered on 51638_00048010155_C indb 208 6 11 13 3 58 PM ...

Page 215: ...miss Lab Test Tomorrow If the lab test time has been set You have a Lab Test tomorrow at Settings Lab Test Time 1 Or if the lab test time has not been set You have a Lab Test tomorrow Dismiss Low bG Retest Low bG Result on last test Retest Snooze Dismiss 5 minutes Other It is time for your Other activity Snooze Dismiss 15 minutes 1 If set the time of the Dr Visit or the Lab Test is displayed on th...

Page 216: ...ng occur when the particular reminder is enabled and scheduled Dr Visit Today Dr Visit Tomorrow Lab Test Today and Lab Test Tomorrow Reminders Displayed when you turn on the meter and a test strip has not been inserted Dismiss the reminder either by pressing or by inserting a test strip Infusion Set Change Reminder Displayed when you turn on the meter and a test strip has not been inserted Dismiss...

Page 217: ...scheduled and no blood glucose test was performed the reminder is displayed when the meter powers down When the meter displays the reminder and you do not press any meter buttons within 30 seconds the meter turns off and displays the reminder again in 2 minutes After the fourth time the meter displays the reminder then the meter dismisses the reminder Dismiss the reminder by pressing Snooze the re...

Page 218: ... scheduled and no blood glucose test was performed the reminder is displayed when the meter powers down When the meter displays the reminder and you do not press any meter buttons within 30 seconds the meter turns off and displays the reminder again in 2 minutes After the fourth time the meter displays the reminder then the meter dismisses the reminder Dismiss the reminder by pressing Snooze the r...

Page 219: ...e the meter turns on and displays the reminder if a test strip has not been inserted If the meter is already on when the reminder is scheduled and no blood glucose test was performed the reminder is displayed when the meter powers down When the meter displays the reminder and you do not press any meter buttons within 30 seconds the meter turns off and displays the reminder again in 2 minutes After...

Page 220: ...ays the reminder then the meter dismisses the reminder bG Test Alarm Clock Reminder If the meter is already on when the reminder is scheduled and no blood glucose test was performed the reminder is displayed when the meter powers down Dismiss all active bG Test reminders by pressing Snooze the reminder for 15 minutes either by pressing or by inserting a test strip When you perform a blood glucose ...

Page 221: ...eady on when the reminder is scheduled the reminder is displayed when the meter powers down Dismiss this reminder either by pressing or by inserting a test strip Snooze the reminder for 15 minutes by pressing 51638_00048010155_C indb 215 6 11 13 3 58 PM ...

Page 222: ...ing Screen Example Warning Icon No Only shown on a few warning screens Warning Title Warning Message Yes or OK NOTE The meter beeps when it displays a warning if the beeper setting is on 51638_00048010155_C indb 216 6 11 13 3 58 PM ...

Page 223: ...st carbs of at least number of carbs 1 Retest bG OK Bolus Advice Bolus Advice data deleted OK Bolus Advice Not Setup Advice not provided unless setup through Bolus Advice in Settings OK Bolus Advice Timeout Bolus Advice no longer possible for this bG result OK Bolus Delivery Unavailable Communication lost Retry or set to Manual Pump OK Bolus Delivery Unavailable Pump unable to start Bolus See Pump...

Page 224: ...Check entries OK Code Key Missing Turn off Meter and insert valid Code Key OK Communication Lost See Pump OK Communication Warning Pump data not available Active Insulin may not be accurate OK Communication Warning Pump data not available recent Bolus data may not be accurate OK Connection Lost Ensure Pump is within range of Meter OK Connection Lost Restart Meter select Settings Meter Pair with Pu...

Page 225: ...ct Set time date on the Pump 2 OK Infrequent Pump Communication Two weeks since last communication with Pump OK Insulin Sensitivity Insulin Sensitivity seems unusual Check entries OK Invalid Active Insulin Unable to calculate the Active Insulin Bolus Advice not available OK Invalid Bolus Advice Times Acting time must be greater than or equal to offset time OK Invalid Date Reenter valid date OK Inv...

Page 226: ...er target range value above upper target range value OK Invalid Target Range Range selected conflicts with Hyper and or Hypo Warning Limit settings OK LO bG Warning Retest bG Contact your doctor OK Meter and Pump Not Paired Pair with Pump to use this feature OK Meter Battery Low Replace soon No Pump connection OK No bG with Bolus Consider testing bG before delivering Insulin Continue No Yes Pairin...

Page 227: ...xpiring Change Code Key and Strips soon OK Time Mismatch Meter time has been changed by more than 5 minutes to match Pump OK 1 The meter displays a recommended amount of fast carbohydrates 2 The meter keeps its current date and time The meter turns off Bluetooth wireless technology communication for this session 51638_00048010155_C indb 221 6 11 13 3 58 PM ...

Page 228: ...creen Example Error Title Error Message Error Icon Menu This option is not available for all errors NOTE The meter beeps when it displays an error even if the beeper setting is turned off 51638_00048010155_C indb 222 6 11 13 3 58 PM ...

Page 229: ...y Menu1 OK2 E 53 Bad Test Error Retest with new Strip E 54 Not Enough Sample Retest with new Strip E 55 Code Key Expired Turn Meter off replace Code Key and Strips Menu1 OK2 E 56 Sample Applied Early Retest with new Strip E 57 Electronic Error Remove batteries wait 20 seconds replace batteries E 58 Temp Error Move Meter to correct temperature and wait 5 minutes Menu3 OK3 51638_00048010155_C indb 2...

Page 230: ...time date if necessary Menu 1 Menu is only displayed when the meter is on a bG test screen 2 OK is only displayed after the splash screen ACCU CHEK logo screen 3 If the meter is powering up then OK is displayed above the right soft key and Menu is not displayed above the left soft key 51638_00048010155_C indb 224 6 11 13 3 58 PM ...

Page 231: ...eaning and Disinfecting the Meter and Lancing Device 7 1 Overview 226 7 2 Cleaning and Disinfecting the Meter 228 7 3 Cleaning and Disinfecting the Lancing Device 233 51638_00048010155_C indb 225 6 11 13 3 58 PM ...

Page 232: ...share the meter and lancing device with anyone including family members due to the risk of infection from bloodborne pathogens 1 2 If the meter is being operated by a second person who is providing testing assistance to the user the meter and lancing device should be cleaned and disinfected prior to use by the second person Disinfect the meter and lancing device before allowing anyone else to hand...

Page 233: ...ancing device 3 3 See Appendix E When should the meter and lancing device be cleaned and disinfected Clean and disinfect the meter and lancing device Once per week When blood gets on the meter or lancing device Before allowing anyone else to handle the meter or lancing device NOTE For technical assistance or questions on cleaning and disinfecting please contact the ACCU CHEK Customer Care Service ...

Page 234: ...e meter to remove visible dirt or other material prior to disinfecting Clean and disinfect the meter at least once per week or when blood is present on the surface of the meter Clean and disinfect the meter before allowing anyone else to handle the meter Do not allow anyone else to use the meter on themselves for testing purposes 51638_00048010155_C indb 228 6 11 13 3 58 PM ...

Page 235: ...tice any of the following signs of deterioration after cleaning and disinfecting your meter stop using your meter and contact the ACCU CHEK Customer Care Service Center at 1 800 688 4578 residue around buttons clouding of display button malfunction out of range controls results What to Clean and Disinfect The following parts of the meter should be cleaned and disinfected The area around slots and ...

Page 236: ...roperly j DO NOT clean or disinfect the meter while performing a blood glucose or control test j DO NOT get any moisture in slots or openings j DO NOT spray anything onto the meter j DO NOT immerse the meter in liquid How to Clean and Disinfect the Meter 51638_00048010155_C indb 230 6 11 13 3 58 PM ...

Page 237: ... surface with the approved cleaning and disinfecting product Always use the same product for both cleaning and disinfecting WARNING The effect of using more than one product interchangeably to clean and disinfect the meter has not been tested Always use the same product to clean and disinfect the meter 51638_00048010155_C indb 231 6 11 13 3 58 PM ...

Page 238: ...aning and disinfection For disinfecting the meter get a new cloth and repeat steps 3 and 4 making sure that the surface stays wet for 2 minutes NOTE Roche has tested the approved product for a total of 416 cycles which is equal to cleaning and disinfecting once per week for a 4 year period j Wash hands thoroughly with soap and water 51638_00048010155_C indb 232 6 11 13 3 58 PM ...

Page 239: ...ow these procedures carefully When to Clean and Disinfect the Lancing Device Clean the lancing device to remove visible dirt or other material prior to disinfecting Clean and disinfect the lancing device once per week to remove visible dirt or other material for safe handling Clean and disinfect the lancing device before allowing anyone else to handle the lancing device for instance if you have so...

Page 240: ...o the lancing device If you notice any of the following signs of deterioration after cleaning and disinfecting your lancing device stop using your lancing device and contact the ACCU CHEK Customer Care Service Center at 1 800 688 4578 residue around buttons difficulty in priming the device difficulty in inserting the lancet drum What to Clean and Disinfect The following parts of the lancing device...

Page 241: ...ing device and the inside of the lancing device cap with the approved cleaning and disinfecting product Always use the same product for both cleaning and disinfecting 3 j A separate Super Sani Cloth should be used for cleaning and disinfection For disinfecting the lancing device get a new cloth and repeat step 2 making sure that the surface stays wet for 2 minutes j Wash hands thoroughly with soap...

Page 242: ...h EPA reg no 9480 4 to clean and disinfect the lancing device Do not use any other cleaning or disinfecting solutions Using solutions other than the Super Sani Cloth could result in damage to the lancing device 4 NOTE Roche has tested the approved product for a total of 520 cycles which is equal to cleaning and disinfecting once per week for a 5 year period 51638_00048010155_C indb 236 6 11 13 3 5...

Page 243: ...8 237 8Maintenance 8 1 Overview 238 8 2 Changing the Batteries 239 8 3 Power Saving Tips 242 8 4 Maintenance and Testing 243 51638_00048010155_C indb 237 6 11 13 3 58 PM ...

Page 244: ...perly care for and maintain your ACCU CHEK Aviva Combo meter If you have any questions about the care and maintenance of your meter contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 51638_00048010155_C indb 238 6 11 13 3 58 PM ...

Page 245: ...g the tab in the direction of the arrow and pulling up the door j Remove the old batteries from the meter j Insert three AAA batteries with the and ends matching the marks in the battery compartment 3 j Put the battery door back in place and snap it closed 51638_00048010155_C indb 239 6 11 13 3 58 PM ...

Page 246: ...plied or recommended may void the warranty Replace all batteries of a set at the same time Newly purchased batteries should not be mixed with partially exhausted ones Batteries of different electrochemical systems grades or brands should not be mixed Failure to observe these precautions may result in some batteries in a set being driven beyond their normal exhaustion point and thus increase the pr...

Page 247: ...nd replace the batteries Rechargeable batteries may be used in the meter However rechargeable batteries may not maintain the same battery life as non rechargeable batteries When the Low Battery warning appears Bluetooth wireless technology communication is disabled If vibrate is set to On it is disabled until the batteries are replaced If the backlight level is set to high the medium backlight lev...

Page 248: ...nserve battery life Use the low beeper setting Only turn on the vibrate feature when it is needed Turn off the meter when you are finished rather than utilizing the auto power off feature 51638_00048010155_C indb 242 6 11 13 3 58 PM ...

Page 249: ...sure your test strips and control solution have not expired and then perform a control test Perform a control test with each new vial of test strips To test the meter display turn off the meter and then press and hold the button The display cycles through colors red blue green and white If any part of the display does not change colors contact ACCU CHEK Customer Care Service Center at 1 800 688 45...

Page 250: ...244 51638_00048010155_C indb 244 6 11 13 3 58 PM ...

Page 251: ...245 9 9Troubleshooting 9 1 Overview 246 9 2 Troubleshooting the ACCU CHEK Aviva Combo Meter 247 51638_00048010155_C indb 245 6 11 13 3 58 PM ...

Page 252: ...t 1 800 688 4578 WARNING Never make treatment decisions based on a warning or error message If you have any concerns contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 NOTE If you drop the meter or think it is not giving accurate results make sure your test strips and control solution have not expired and then perform a control test For further assistance contact ACCU CHEK Customer C...

Page 253: ...Center at 1 800 688 4578 j Extreme temperature the temperature is outside the meter operating range j Move the meter to an area with proper temperature Wait five minutes before turning on the meter Do not artificially heat or cool the meter Bluetooth icon flashing j Communication ended due to a button press on the pump j Check the pump and continue operation of the pump manually j Ensure the pump ...

Page 254: ...olutions Beep Vibrate Off j Beep and Vibrate settings cannot be turned off at the same time j Ensure that either the Beep or Vibrate setting is turned on See Chapter 5 Changing Meter Settings Below Hypo Warning Limit j Your test result is below the hypo warning limit set in the meter j Treat your low blood glucose as recommended by your healthcare professional j The meter displays a recommended nu...

Page 255: ... bolus history however the bolus history is available on the pump Bolus Advice Not Setup j Advice is not provided unless it is set up through Bolus Advice in Settings Menu j You can continue to use the meter without bolus advice or see Chapter 5 Changing Meter Settings for instructions on how to set up bolus advice Bolus Advice Timeout j Bolus advice is no longer available for this bG result j Rev...

Page 256: ...e with the pump Replace the batteries j The pump is currently in Stop mode j Take the pump out of Stop mode j The pump is currently delivering a bolus j Allow the current bolus delivery to complete before delivering the next bolus Bolus Too High j The bolus is above the allowed amount The bolus was set to 50 Units j Check the accuracy of all entries If necessary contact your healthcare professiona...

Page 257: ...k code key please contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 Communication Lost j Pump is out of range of the meter j Bolus delivery continuing see pump screen j Ensure the meter and pump have Bluetooth wireless technology turned on j Ensure the meter and pump are within communication range j If the low battery icon is displayed on the meter the meter cannot communicate with ...

Page 258: ...on of bolus data from the pump was not successful Therefore pump data are not available and the active insulin amount may not be accurate j Ensure the meter and pump have Bluetooth wireless technology turned on j Ensure the meter and pump are within communication range j If the low battery icon is displayed on the meter the meter cannot communicate with the pump Replace the batteries 51638_0004801...

Page 259: ... cannot communicate with the pump Replace the batteries j Pump is out of range of the meter j Ensure the meter and pump are within communication range Diary Entry Used For Advice j The diary entry selected has been used for bolus advice and modifications are not allowed j Carefully confirm all information involving bolus advice You cannot modify bolus advice related entries on the meter Diary Resu...

Page 260: ...blood glucose test and see Chapter 2 Testing Your Blood Glucose j The test strip is damaged j The test strip is not properly inserted into the meter If you see this error message before you applied blood to the test strip j Remove the test strip and reinsert it or replace it if damaged Check the Use By date on the test strip container Do not use test strips past the Use By date If the message reap...

Page 261: ...e If this still does not match the way you feel run a control test with your control solution 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 the E 53 error still appears for your blood glucose test your blood glucose test result may be extremely high and above the system s rea...

Page 262: ...in the meter It means the test strips expire at the end of the current month At the end of the month discard the white code key and any remaining test strips Insert a black code key Make sure the time and date in the meter are correct If you need a black code key please contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 E 56 Sample Applied Early j Blood or control solution was applie...

Page 263: ...ror j The temperature is above or below the proper range for the meter j Move the meter to an area within the proper temperature range indicated for test strip use in the test strip package insert Wait 5 minutes before turning on the meter Repeat the test Do not artificially heat or cool the meter E 59 Battery Empty j The batteries are extremely low j Insert new batteries See Chapter 8 Maintenance...

Page 264: ...ons Incorrect Pump Time Date j Pump time date incorrect j Set time date on the pump see pump User Guide Infrequent Pump Communication j At least two weeks have passed since the meter and pump have communicated j Ensure the meter and pump have Bluetooth wireless technology turned on j Ensure the meter and pump are within communication range j If the low battery icon is displayed on the meter the me...

Page 265: ... date Invalid Hyper Values j The hyper warning limit value must be greater than all of your target ranges in the time block settings j Reset the hyper warning limit or revise the target ranges in time blocks and re enter the hyper warning limit j Enter a hyper warning limit that is above the target ranges of your time blocks See Chapter 5 Changing Meter Settings Invalid Hypo Values j The hypo warn...

Page 266: ...nd upper target range value See Chapter 5 Changing Meter Settings j The range selected conflicts with your hyper and or hypo warning limit settings j Reset range or revise warning limit settings and re enter range j Enter the correct lower target range value and upper target range value See Chapter 5 Changing Meter Settings LO bG Warning j Your blood glucose may be lower than the measuring range o...

Page 267: ...bG with Bolus j You have not tested your bG and are attempting to deliver a bolus j It is recommended to test bG before delivering insulin Pairing Failed j The attempt to pair the meter and pump was unsuccessful j Restart the pairing process See the Advanced Owner s Booklet Pump Not Available j The pump is out of the communication range of the meter j Ensure the meter and pump have Bluetooth wirel...

Page 268: ...e the time and date in the meter are correct If you need a black code key please contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 j Ensure the time and date are correct and adjust if necessary See Chapter 5 Changing Meter Settings Time Mismatch j The time or date on the meter is more than five minutes different than the time or date on the pump j The meter time and date were change...

Page 269: ...rors and warnings see Chapter 6 Icons Reminders Warnings and Errors If you have a question or if you see any other error screen please contact ACCU CHEK Customer Care Service Center at 1 800 688 4578 51638_00048010155_C indb 263 6 11 13 3 58 PM ...

Page 270: ...264 51638_00048010155_C indb 264 6 11 13 3 58 PM ...

Page 271: ...Product Limitations 267 10 3 Specifications 268 10 4 Product Safety Information 270 10 5 Disposing of the Meter Strips Lancets and Batteries 273 10 6 Warranty and Limited License 275 10 7 Additional Supplies 282 51638_00048010155_C indb 265 6 11 13 3 58 PM ...

Page 272: ...266 10 1 Overview This chapter provides you with important performance information regarding the meter 51638_00048010155_C indb 266 6 11 13 3 58 PM ...

Page 273: ...267 10 2 Product Limitations Please read the literature packaged with your test strips to find the latest information on product specifications and limitations 51638_00048010155_C indb 267 6 11 13 3 58 PM ...

Page 274: ...p storage conditions Refer to the test strip package insert Meter storage conditions with batteries inserted 4 F to 122 F System operating conditions Refer to the test strip package insert Relative humidity operating range Refer to the test strip package insert Memory capacity 1 000 diary records Automatic power off 2 minutes Power supply Three AAA batteries recommended alkaline 51638_00048010155_...

Page 275: ...3 6 oz with batteries inserted Construction Hand held Protection class III Meter type The ACCU CHEK Aviva Combo meter is suitable for continuous operation Control solution storage conditions 36 F to 90 F Interface IR LED IRED Class 1 51638_00048010155_C indb 269 6 11 13 3 58 PM ...

Page 276: ...hnology devices e g cell phone printer etc cannot be paired with communicate with or access your personal information on the meter or the pump Radio Frequency Communication FCC ID WX3 361 The device complies with the United States Federal Communications Commission FCC standards The device complies with FCC Part 15 Rules Operation of the device is subject to the following two conditions 1 this devi...

Page 277: ...y This equipment complies with FCC and IC radiation exposure limits set forth for an uncontrolled environment This equipment is in direct contact with the body of the user under normal operating conditions This transmitter must not be co located or operated in conjunction with any other antenna or transmitter Electromagnetic Compatibility This meter meets the electromagnetic immunity requirements ...

Page 278: ...xokinase method with deproteinization automatic analyzer The hexokinase method is traceable to an NIST standard Measuring Principle Refer to your test strip package insert for more information WARNING Strong electromagnetic fields may interfere with the proper operation of the meter Do not use this meter close to sources of strong electromagnetic radiation To avoid electrostatic discharge do not u...

Page 279: ... points when disposing of your used testing materials Comply with any laws or ordinances relating to the disposal of sharps and or contaminated products Contact your local health department or other appropriate authorities for proper handling and disposal of used meters used test strips used lancets and used batteries Consider recycling of the meters and batteries at an appropriate facility Be awa...

Page 280: ...s i e healthcare professionals should follow their existing policies and procedures that govern the proper handling and disposal of potentially infectious waste e scrap and batteries 29 CFR 1910 1030 Bloodborne pathogens Code of Federal Regulations 51638_00048010155_C indb 274 6 11 13 3 58 PM ...

Page 281: ...rials or workmanship Roche will replace it with a new ACCU CHEK Aviva Combo meter or equivalent product free of charge The warranty on the replacement meter will expire on the date of the original warranty expiration or 90 days after the shipment of a replacement system whichever period is longer The purchaser s exclusive remedy with respect to the ACCU CHEK Aviva Combo meter shall be replacement ...

Page 282: ...IN ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION OF THE METER OR ITS PARTS NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IF ANY IS IMPLIED FROM THE SALE OF THE METER SHALL EXTEND FOR A LONGER DURATION THAN FOUR YEARS FROM THE DATE OF PURCHASE Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damage...

Page 283: ...or shipping the system to Roche Cartons received without this label will be returned to you at your expense Customers experiencing difficulties should review the troubleshooting information in Chapter 9 of this booklet Further inquiries should be directed to ACCU CHEK Customer Care Service Center at 1 800 688 4578 Be sure to fill out and mail the Warranty Card that comes with the ACCU CHEK Aviva C...

Page 284: ... 303 801 expires 4 October 2022 and 8 329 026 expires 4 October 2022 A license to use the ACCU CHEK Aviva Combo system is required until the expiration of the last to expire patent listed above and is only granted when the ACCU CHEK Aviva Combo meter is used with the ACCU CHEK Aviva Plus test strips and ACCU CHEK Aviva Plus code keys ACCU CHEK Aviva Plus test strips are provided with a specificall...

Page 285: ...the place of purchase the unused ACCU CHEK Aviva Combo system for a full refund If you have any questions please call the ACCU CHEK Customer Care Services Center at 1 800 688 4578 Except where prohibited by statute all warranties covering the ACCU CHEK Aviva Combo system are voided by use of the ACCU CHEK Aviva Combo system with any test strips or code keys other than ACCU CHEK Aviva Plus test str...

Page 286: ... FastClix system is required until the expiration of the last to expire patent listed above and is only granted when ACCU CHEK FastClix lancet drums are used with the ACCU CHEK FastClix device ACCU CHEK FastClix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the ACCU CHEK FastClix device Use of other lancet drums with t...

Page 287: ...se you may return at the place of purchase the unused ACCU CHEK FastClix device for a full refund If you have any questions please call the ACCU CHEK Customer Care Services Center at 1 800 688 4578 Except where prohibited by statute all warranties covering the ACCU CHEK FastClix device are voided by use of the ACCU CHEK FastClix device with any lancet drums other than ACCU CHEK FastClix lancet dru...

Page 288: ...ditional Supplies Test Strips ACCU CHEK Aviva Plus 50 ct test strips ACCU CHEK Aviva Plus 100 ct test strips Control Solutions ACCU CHEK Aviva 2 level control solutions 51638_00048010155_C indb 282 6 11 13 3 58 PM ...

Page 289: ...qual to 12 grams of carbohydrates bG Blood Glucose Carbs Carbohydrates CC Carbohydrate Choice equal to 15 grams of carbohydrates F Degrees Fahrenheit FCC Federal Communications Commission United States g Grams GHz Gigahertz Hyper Hyperglycemia high blood glucose Hypo Hypoglycemia low blood glucose 51638_00048010155_C indb 283 6 11 13 3 58 PM ...

Page 290: ...s LCD Liquid Crystal Display mg dL Milligrams per Deciliter N A Not Applicable NIST National Institute of Standards and Technology United States PIN Personal Identification Number PM Post Meridiem 12 hour clock notation for after noon RF Radio Frequency SD Standard Deviation U Units bolus insulin units 51638_00048010155_C indb 284 6 11 13 3 58 PM ...

Page 291: ...asure are available on the meter Abbreviation Unit of Measurement Gram Equivalent g Grams 1 gram KE Kohlenhydrateinheit 10 grams BE Bread Equivalent 12 grams CC Carbohydrate Choice 15 grams Standard unit of measure in the U S 51638_00048010155_C indb 285 6 11 13 3 58 PM ...

Page 292: ...tions for the ACCU CHEK Aviva Combo meter shown here with their meaning w Caution refer to safety related notes in the instructions for use accompanying this product Federal law USA restricts this device to sale by or on the order of a physician per 21 CFR 801 109 1 5V AAA Code of Federal Regulations 51638_00048010155_C indb 286 6 11 13 3 58 PM ...

Page 293: ...hold High mg dL 120 350 1 Hyper Warning Limit bG Threshold Low mg dL 50 100 1 Hypo Warning Limit Carb Ratio carbs grams BE KE CC 1 0 1 0 1 0 1 240 20 24 16 1 0 1 0 1 0 1 No entry g No entry BE No entry KE No entry CC Carb Ratio insulin Units 0 1 50 0 1 1 Carbohydrates grams BE KE CC 0 0 0 0 240 20 24 16 1 0 1 0 1 0 1 No entry g No entry BE No entry KE No entry CC 51638_00048010155_C indb 287 6 11 ...

Page 294: ...nsulin Units 0 501 0 1 N A Hyper Warning Limit mg dL 180 350 1 300 Hypo Warning Limit mg dL 50 90 1 70 Illness health event 50 50 1 0 Insulin Sensitivity bG mg dL 1 999 1 No entry mg dL Insulin Sensitivity insulin Units 0 1 50 0 1 1 Meal Rise bG mg dL 50 200 1 50 Multiwave Bolus insulin Units 0 2 501 0 1 N A 51638_00048010155_C indb 288 6 11 13 3 58 PM ...

Page 295: ...24 2 2 4 1 6 1 0 1 0 1 0 1 No entry g No entry BE No entry KE No entry CC Standard Bolus insulin Units 0 501 0 1 N A Stress health event 50 50 1 0 Target Range Upper Value mg dL 100 300 1 140 Target Range Lower Value mg dL 50 140 1 70 1 The maximum that can actually be delivered may be less due to the ACCU CHEK Spirit Combo pump s maximum insulin amount 51638_00048010155_C indb 289 6 11 13 3 58 PM...

Page 296: ...rn on a bG test reminder see Setting Alarm Clock Reminders bG Test Other in Chapter 5 Changing Meter Settings Test Reminder Default Time of Day 1 7 00 am 2 9 00 am 3 11 00 am 4 12 00 pm 5 2 00 pm 6 4 00 pm 7 7 00 pm 8 10 00 pm 51638_00048010155_C indb 290 6 11 13 3 58 PM ...

Page 297: ...ional about setting up time blocks to help you manage your diabetes To adjust the time blocks see Chapter 5 Changing Meter Settings Time Block 12 Hour Format 1 12 00 am 5 30 am 2 5 30 am 11 00 am 3 11 00 am 5 00 pm 4 5 00 pm 9 30 pm 5 9 30 pm 12 00 am 51638_00048010155_C indb 291 6 11 13 3 58 PM ...

Page 298: ...C Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html Accessed March 20 2012 3 Healthcare Infection Control Practices Advisory Committee HICPAC William A Rutala Ph D M P H and David J Weber M D M P H Centers for Disease Control and Prevention 2008 Guideline for Disinf...

Page 299: ...ing meal rise snack size acting time and offset time After High bG Reminder A reminder to retest your blood glucose When enabled this reminder occurs after a high blood glucose test result After Low bG Reminder A reminder to retest your blood glucose When enabled this reminder occurs after a low blood glucose test result After Meal Reminder A reminder to retest your blood glucose When enabled this...

Page 300: ...rder to exchange information Bolus The delivery of insulin all at once rather than slowly throughout the day usually used to compensate for meals or high blood glucose Bolus Advice When enabled bolus advice provides recommendations on the amount of insulin for food intake and for correcting blood glucose levels that are not within your target range Bolus Advice Options See Advice Options Bolus Del...

Page 301: ...he range shown on the label of the test strip container then the test strips and the meter are working properly Control Test A meter test using control solution which lets you know that the meter and test strips are working properly Corrupt Result bG test result that had an error Current Date Refers to the date you set through the menu Settings and then in the Time Date screen Current Time Refers ...

Page 302: ...ored with a blood glucose test result or in a diary record and percentages that could adjust bolus advice recommendations for your current health status or activities HI The test result is above the meter s measurement range Hyper Hyperglycemia an abnormally high level of glucose in the blood Hyper Warning Limit When your blood glucose test result is above the hyper warning limit a warning is disp...

Page 303: ...ns in order to prevent its unintended use LO The test result is below the meter s measurement range Meal Rise During or after meals an increase in blood glucose levels is considered normal within a certain range even through a meal bolus has been delivered Enter the maximum increase in your blood glucose test result that is to be tolerated without an additional correction bolus Meal Time During or...

Page 304: ...pected delay for the blood glucose level to actually fall during the acting time of insulin in the body It describes the first time period within the acting time Paired A pump and meter exclusively communicating and transferring information with each other Pump See Insulin Pump Quick Bolus A bolus delivery on the pump using the pump UP and DOWN keys One key press equals one bolus increment i e 0 1...

Page 305: ...Bolus A bolus that is immediately delivered to cover a food or a blood glucose correction When Standard is selected the bolus is delivered by the pump This option is available only when Bluetooth wireless technology is turned on and the meter and pump are communicating Standard Deviation As it is used in this owner s booklet standard deviation measures how widely spread the bG test results are e g...

Page 306: ...hout the day Time Range The user sets the duration of time There is a start and end time User A person using the meter or pump Warning Describes items and conditions that present hazards and may cause personal injury Warning Limits See Hyper Warning Limit or Hypo Warning Limit 51638_00048010155_C indb 300 6 11 13 3 58 PM ...

Page 307: ...146 210 214 215 appetite increased 61 B backlight button 13 17 18 display 20 settings 199 200 batteries 14 changing 239 241 low 31 type 239 241 BE 179 181 285 beeper settings 31 185 187 bG threshold 141 142 blood glucose averages 97 98 blood glucose test features 21 performing 43 51 reminder 28 206 290 results 48 51 60 unusual results 55 60 Bluetooth wireless technology communication 270 271 turni...

Page 308: ... code key code key 15 251 254 256 communication 247 251 253 258 control solution 14 66 69 control test performing 65 67 72 results 70 71 73 76 results troubleshooting 77 78 D data adding 52 54 92 94 downloading to a computer 24 133 135 modifying 83 91 reporting 95 132 trends 23 99 108 viewing 83 91 date reminders 29 147 151 210 setting 188 190 display 13 20 247 disposing meter 273 274 dr visit rem...

Page 309: ...eminder 208 212 hyper warning limit 24 170 172 248 259 hypo warning limit 24 170 172 248 259 I icons listing 85 86 203 204 infrared IR window 13 14 134 infusion set change reminder 147 151 208 210 insulin pump 19 insulin pump connecting See pairing insulin sensitivity 156 259 K KE 179 181 285 key lock 18 21 173 175 key sound settings 185 187 L lab test reminder 147 151 209 210 lancing device 46 47...

Page 310: ...mbness 61 O offset time 159 160 169 P pairing 18 184 power button 13 16 18 power saving tips 242 pump See insulin pump R rapid heartbeat 61 reminders blood glucose test See blood glucose test reminder important information 210 215 list of 206 209 other 209 priority 210 S safety information product 270 272 screen features 31 34 35 scroll bar 34 signal settings 21 51638_00048010155_C indb 304 6 11 1...

Page 311: ...andard week 123 125 target 130 132 trend 105 108 target range 153 156 164 191 193 260 target reporting 126 133 test results storing 81 82 unusual 59 60 test strip 254 262 thirst increased 61 time blocks 25 26 152 165 191 198 291 time change data 100 102 105 106 time format setting 188 189 time setting 188 190 tingling 61 trembling 61 troubleshooting 247 263 U units of measure See carbohydrates uni...

Page 312: ...306 V vibrate settings 185 187 W warnings list of 216 221 warranty 275 277 51638_00048010155_C indb 306 6 11 13 3 58 PM ...

Page 313: ...307 51638_00048010155_C indb 307 6 11 13 3 58 PM ...

Page 314: ...308 51638_00048010155_C indb 308 6 11 13 3 58 PM ...

Page 315: ...LAST UPDATE 2012 08 51638_00048010155_C indb 2 6 11 13 3 57 PM ...

Page 316: ...Roche Diagnostics Assembled in USA Distributed by Roche Health Solutions Inc 11800 Exit 5 Parkway Suite 120 Fishers IN 46034 Phone 1 800 280 7801 Fax 1 888 810 0758 ACCU CHEK ACCU CHEK AVIVA ACCU CHEK AVIVA COMBO ACCU CHEK SPIRIT COMBO and FASTCLIX are trademarks of Roche The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by Roche is un...

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