Aviva Combo 00048010156/C-0613 This file may not print or view at 100%. Die lines and color breaks do not print. ©2013 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 51639_00048010156_C.indb 1 ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and FASTCLIX are trademarks of Roche.
LAST UPDATE: 2012-08 51639_00048010156_C.
Before You Start Testing Roche USA – 51639 V4/1 – 00048010156/C – Black – About the meter and test strips • Carefully read and follow the instructions in the Getting Started Guide, the Standard Owner’s Booklet, the Advanced Owner’s Booklet, and Package Inserts for the test strips and control solutions. Not following the instructions may lead to a wrong result or improper treatment, causing you health problems.
About Your New Meter • The meter is designed and can be used for testing fresh capillary whole blood samples (for example, blood from a fingertip). • Only use ACCU-CHEK Aviva Plus test strips. Other test strips will give inaccurate results. • Although 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).
About Testing Yourself or Others • If you are very dehydrated or urinating frequently, you may get an inaccurate test result. If you think you are dehydrated, call your healthcare professional right away. • Some people with diabetes do not experience symptoms of low blood glucose (hypoglycemia). Others, such as children or people who are unconscious or have certain disabilities, may not be able to communicate their symptoms to caregivers.
• Refer to the Test Strip and Control Solution Package Inserts for additional health-related information. • It is always a good idea to have a back-up testing method available. Failure to test could cause a delay in treatment decisions and lead to a serious medical condition. Examples of back-up testing methods include a back-up meter or testing by a lab. Ask your healthcare professional or pharmacist about other possible back-up methods.
Contents Before You Start Testing i Introduction 5 1 Bolus Advice 1.1 Overview 1.2 Before Using Bolus Advice 1.3 Calculating and Delivering a Bolus Using Bolus Advice 2 Administering a Bolus 2.1 Overview 2.2 Choosing Your Bolus Type 2.3 Delivering a Bolus 2.4 Updating the Diary with Bolus Information 7 8 10 13 25 26 27 29 31 1 51639_00048010156_C.
3 Using the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump 3.1 Overview 3.2 The System at a Glance 3.3 Controlling the Pump with the Meter 3.4 Managing Pump Errors, Warnings, and Reminders with the Meter 4 Communication between the ACCU-CHEK Aviva Combo Meter and ACCU-CHEK Spirit Combo Pump 4.1 Overview 4.2 Turning Bluetooth® Wireless Technology On/Off 4.3 Using the System While Traveling 4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump 4.
Appendices Appendix A: Bolus Advice Appendix B: Bolus Advice Calculations Appendix C: Explanation of Symbols Appendix D: Limited License 79 79 98 102 103 Index 107 3 51639_00048010156_C.
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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 Booklet, and the Advanced Owner’s Booklet carefully before you use your new meter. To use it correctly and dependably, you need to understand its operation, screen displays, and all individual features.
WARNING Choking hazard. Small parts. Keep away from children under the age of 3 years. 6 51639_00048010156_C.
1 1 Bolus Advice 1.1 Overview 1.2 Before Using Bolus Advice 1.3 Calculating and Delivering a Bolus Using Bolus Advice 8 10 13 7 51639_00048010156_C.
1.1 Overview Important information regarding the use of bolus advice is presented in this chapter. Read it carefully and completely before you begin using bolus advice. • It is recommended you discuss your bolus advice settings with your healthcare professional prior to setting up this feature. • Bolus advice is intended exclusively for use by well-trained individuals who perform their own insulin therapy. • Bolus advice is only available if you have set up bolus advice on your meter.
1 NOTE • This booklet shows sample screens. The screens in this booklet may look slightly different from the screens on your ACCU-CHEK Aviva Combo 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. 9 51639_00048010156_C.
1.2 Before Using Bolus Advice As with any specialized feature, you need to understand certain information in order to use bolus advice. Working closely with your healthcare professional, you must be completely familiar with your diabetes therapy. You must also be able to judge your current situation accurately. Bolus advice calculates boluses for you. This can help you determine the amount of insulin you currently require. You provide the information on which the bolus advice calculations are based.
1 Safety Information Regarding Bolus Advice WARNING • It is very important you follow the safety information in this chapter. • Always compare your result with the way you actually feel and adjust the recommended bolus, if necessary. • Always carry out the actions entered into bolus advice in a timely fashion. Eat the carbohydrate amount you entered and administer the insulin dose.
Warning messages about your blood glucose test result After performing a blood glucose test, warning messages about your blood glucose test result may be displayed. Please take careful note of these messages. If your blood glucose test result is too low, you are prompted to eat a certain amount of fast acting carbohydrates to prevent the risk of hypoglycemia. A bolus is not calculated in this situation. Treat your low blood glucose as recommended by your healthcare professional.
1 1.3 Calculating and Delivering a Bolus Using Bolus Advice bG Test Result Active Insulin Recommended Bolus Amount Carb Entry Health Event Entry Bolus Type 13 51639_00048010156_C.
To Deliver a Bolus Main Menu > Bolus Advice 1. 2. Standard Owner’s Booklet for information on how to perform a blood glucose test. When the detailed bG Result screen appears, select Bolus. j From the Main Menu, select Bolus Advice and press =. j If you have not completed a recent blood glucose test (this is indicated when “bG Test” is displayed near the top of the meter screen rather than an actual bG value), it is recommended you complete a blood glucose test. Select bG Test and press =.
3. To Adjust the Bolus Amount: j Select the Bolus entry field and press =. j Set the Bolus insulin amount and press =. To deliver a … j Standard Bolus: Step 3 j Multiwave Bolus: Step 6 j Extended Bolus: Step 9 j Bolus manually on the Pump: Step 12 j Bolus using an Insulin Pen or Syringe: Step 14 1 4. To Deliver a Standard Bolus j Select the Type entry field and press =. j Select Standard and press =. To confirm the entries, select Confirm.
5. You can choose one of the following: j Select OK and display the Main Menu. Bolus delivery continues until it is complete. j To stop bolus delivery, select Stop Bolus. The Pump screen BOLUS CANCELLED appears. Note: Bolus delivery can be stopped using your pump. For instructions, see the pump User Guide. If no buttons are pressed, when the bolus delivery is complete the Delivery Completed screen appears. j Select Menu to go to the Main Menu. 16 51639_00048010156_C.
6. 1 7. To Deliver a Multiwave Bolus j Select the Type entry field and press =. j Select Multiwave and press =. j To deliver the Multiwave bolus remotely on your pump using your meter, select Deliver. j To return to the Bolus Advice screen, select Back. To confirm the entries, select Confirm. j To change the immediate bolus, select Immediate entry field and press =. j Set the bolus amount and press =. j To change the duration, select the Duration entry field and press =.
8. You can choose one of the following: j Select OK and display the Main Menu. Bolus delivery continues until it is complete. j To stop bolus delivery, select Stop Bolus. The Pump screen BOLUS CANCELLED appears. Note: Bolus delivery can be stopped using your pump. For instructions, see the pump User Guide. If no buttons are pressed, when the bolus delivery is complete the Immediate Delivery Completed screen appears. j Select Menu to go to the Main Menu. 18 51639_00048010156_C.
9. 1 10. 11. j To adjust the duration, select the Duration entry field and press =. j Set the length of duration and press =. j To deliver the Extended bolus remotely on your pump using your meter, select Deliver. j To return to the Bolus Advice screen, select Back. j Select Menu to go to the Main Menu. To Deliver an Extended Bolus j Select the Type entry field and press =. j Select Extended and press =. To confirm the entries, select Confirm. Note: Bolus delivery can be stopped using your pump.
12. To Deliver a Bolus Manually on the Pump j Select the Type entry field and press =. j Select Manual Pump and press =. To confirm the entries, select Confirm. 13. WARNING Start the delivery of the exact bolus amount on the pump within 10 minutes. See WARNING at the end of this section. The bolus amount is displayed on the meter screen. j Manually program the pump and deliver the bolus, or if necessary, select Back and return to the Bolus Advice screen to adjust the bolus.
14. To Deliver a Bolus Using an Insulin Pen or Syringe j Select the Type entry field and press =. j Select Pen/Syringe and press =. To confirm the entries, select Confirm. 15. 1 The bolus amount is displayed on the meter screen. j Inject the bolus using an insulin pen or syringe or, if necessary, select Back and return to the Bolus Advice screen to adjust the bolus. j Select OK to go to the Main Menu. 21 51639_00048010156_C.
WARNING • Bolus advice provided by the meter is solely advice. Contact your healthcare professional prior to changing your diabetes therapy. • It is important to make the correct selection for the carbohydrate ratio and insulin sensitivity. If you select the wrong ratio (the basis for all calculations), all future bolus advice recommendations will be wrong. • If a pump bolus delivery is stopped, the bolus amount stored in the meter is updated when the next pump synchronization occurs.
1 NOTE • Bolus advice can also be accessed after you perform a bG Test (see the Standard Owner’s Booklet). When the detailed bG Result screen is displayed, press .. This is not available if your bG result is below your hypo warning limit (red color bar is displayed). • For additional information about different bolus types, see Chapter 2, Administering a Bolus. • You can only select one health event for each bolus recommendation. 23 51639_00048010156_C.
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2 2 Administering a Bolus 2.1 Overview 2.2 Choosing Your Bolus Type 2.3 Delivering a Bolus 2.4 Updating the Diary with Bolus Information 26 27 29 31 25 51639_00048010156_C.
2.1 Overview There are several methods to deliver a bolus. 26 51639_00048010156_C.
2 2.2 Choosing Your Bolus Type There are several types of bolus delivery available. The bolus types include: • Standard 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. • Multiwave A bolus designed to better simulate the body’s insulin delivery.
• Extended A bolus delivered over a period of time. The Extended Bolus might be helpful, for example, during long meals, dinners, or receptions, or when you have meals that are digested slowly or for people who have gastroparesis (delayed digestion). This option is available only when Bluetooth wireless technology is turned on and the meter and pump are communicating. • Manual Pump A Manual Pump bolus type is available when using bolus advice.
2 2.3 Delivering a Bolus WARNING • Incorrect meter settings may cause inappropriate insulin delivery. • The meter must be configured with your personal settings prior to administering a bolus. If you are not sure about your personal settings, talk to your healthcare professional. • Work with your healthcare professional to determine the timing, amount, and type of bolus you need to deliver.
NOTE You can cancel a bolus (including an extended bolus) that is being delivered by the pump directly on the pump or remotely using the meter (through the Pump Menu on the meter). Delivering a Bolus Using Bolus Advice For instructions on how to deliver a bolus using bolus advice, see Chapter 1, Bolus Advice. Delivering a Bolus Using an Insulin Pen or a Syringe Follow the instructions of your healthcare professional when delivering a bolus using an insulin pen or a syringe.
2 2.4 Updating the Diary with Bolus Information When the pump is synchronized with the meter, bolus information from the pump is imported into the meter. For any manual pump bolus record in the meter database with a time stamp that is older than 10 minutes and is not confirmed by the pump, the meter does away with the bolus record by changing the bolus amount to “0.0” on the next meter and pump synchronization.
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3 3 Using the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump 3.1 Overview 3.2 The System at a Glance 3.3 Controlling the Pump with the Meter 3.4 Managing Pump Errors, Warnings, and Reminders with the Meter 34 35 38 53 33 51639_00048010156_C.
3.1 Overview The ACCU-CHEK Aviva Combo meter can be used to remotely control the ACCU-CHEK Spirit Combo insulin pump using Bluetooth wireless technology. Before using the meter to control the pump, it is important to understand how to operate the pump using the meter. If you experience any communication problems between the pump and meter, it is recommended that you go directly to the pump and operate the pump manually.
3 3.2 The System at a Glance In the meter’s Pump Menu, the meter buttons have different functions. The buttons function as button (key) presses on the pump. The pump sends screens to the meter. d f The meter sends button presses to the pump. 35 51639_00048010156_C.
Button Functions in the Pump Menu Meter Button Pump Key Function x a j Move forward in an information screen j Increase a setting j Program a Quick Bolus j Cancel a Quick Bolus j Turn off the STOP-Warning z s j Move backward in an information screen j Decrease a setting j Program a Quick Bolus j Cancel a Quick Bolus j Turn off the STOP-Warning < > d f j Cycles through menus, functions, and information screens j Selects current settings displayed on screen j Saves changes j Exits a screen j Allows
Meter Button . Pump Key d , and None Function a 3 j Exits menus, function screens, and information screens without saving your changes j Move to the previous screen j Return to the Main Menu 37 51639_00048010156_C.
3.3 Controlling the Pump with the Meter When Bluetooth wireless technology is turned on, the pump main screen appears on the meter when you are in the Pump Menu.
The following pump functions cannot be remotely controlled using the meter: 3 • Changing the insulin cartridge • Priming the infusion set • Rewinding the piston rod • Data transfer (to a computer) • Bluetooth wireless technology menu • Display orientation and contrast 39 51639_00048010156_C.
NOTE • You can administer a bolus manually on the pump (without using the meter). When the meter and Bluetooth wireless technology are both turned on, the pump automatically transfers bolus information to the meter. If bolus advice is used, it is important you enter carbohydrate information into the meter for boluses delivered manually on the pump so that accurate bolus advice calculations are made. • When the meter is in the Pump Menu, the meter beeps and/or vibrates similarly to the pump.
3 Pump Screens on the Meter Pump Screen Corresponding Meter Buttons Return to Main Menu Bluetooth Wireless Technology Icon Back Pump double button press (d and a) 41 51639_00048010156_C.
In remote control mode, the Bluetooth wireless technology icon appears on the meter screen and on the pump screen. To control the pump using the meter, you must be in the Pump Menu. From the Pump Menu, use the corresponding meter buttons to scroll through the pump menus and submenus (the same as you would on the pump). Instructions for how to deliver a standard bolus, how to program a temporary basal rate (TBR), and how to change the basal rate profile using the meter are provided in the following sections.
3 Delivering a Bolus – Standard Bolus To Program a Standard Bolus Remotely Using the Meter 1. 2. 3. j From the Main Menu, select Pump and press =. j Repeatedly press and release < until the STANDARD BOLUS screen appears. j Press > to select the Standard Bolus menu. 43 51639_00048010156_C.
4. 5. 6. j Press x to increase or z to decrease the bolus amount. j When the correct bolus amount is displayed, press > to confirm the bolus amount. j The Standard Bolus icon blinks for 5 seconds (bolus delivery start delay). The meter beeps three times and vibrates once, then the pump begins to deliver the bolus amount. A countdown of the remaining bolus amount to be delivered appears on the meter display. 44 51639_00048010156_C.
3 Cancelling a Standard Bolus You may cancel a Standard bolus delivery. Time Cancelling the Bolus Result When programming a Standard j If you do not press any meter A bolus is not delivered. bolus (the bolus amount blinks on buttons for approximately the screen) 20 seconds, the meter returns to the Pump Run screen. j Exit the BOLUS AMOUNT screen and return to the STANDARD BOLUS screen by pressing . or by pressing < and x simultaneously. j Set the bolus amount to 0.0 units.
Time Cancelling the Bolus Result During bolus delivery (meter is j Press and hold x or z for Bolus delivery is interrupted and counting down the bolus amount) 3 seconds until the meter beeps. stopped. The meter displays the pump warning W8: BOLUS CANCELLED. Press > twice to confirm and mute the warning. You can view the actual bolus amount that was delivered prior to the bolus cancellation by viewing the pump bolus history. For more information, see the pump User Guide.
3 Programming a Temporary Basal Rate (TBR) 1. 2. 3. j From the Main Menu, select Pump and press =. j Repeatedly press and release < until the TEMPORARY BASAL RATE (TBR) screen appears. j Press > to select the Temporary Basal Rate (TBR) menu. 47 51639_00048010156_C.
4. 5. 6. j Press x or z to increase or decrease the TBR. j When the correct TBR percentage is selected, press <. The TBR DURATION screen appears. j Press x or z to set the duration time. j Press > to save the changes. The Run screen with the TBR appears. The new TBR is activated. The meter beeps when the activation occurs. 48 51639_00048010156_C.
3 NOTE • If a TBR is not currently active, the TBR percentage is set to 100 %. • When a TBR is active, it remains in effect even if the basal rate profile is changed. • A TBR can only be programmed when the pump is in RUN mode. • When a TBR is active, the pump beeps and vibrates every hour. The meter beeps and vibrates if the meter is in the pump mode (in a Pump screen). • For more information about programming a TBR, see the pump User Guide. At the end of a TBR, the pump warning W7: TBR OVER appears.
Cancelling a Temporary Basal Rate Situation Cancelling the Temporary Basal Rate When programming a TBR j If you do not press any meter buttons The pump continues to for approximately 20 seconds, the meter deliver the normal basal returns to the Pump Run screen. rate. j Return to the TEMPORARY BASAL RATE (TBR) screen by pressing . or by pressing < and x simultaneously. j Set the TBR percentage to 100 %. Press > to exit the TBR PERCENTAGE screen. Result During the delivery of the TBR j Press ..
3 Changing a Basal Profile 1. 2. 3. j From the Main Menu, select Pump and press =. j Repeatedly press and release < until the BASAL RATE SELECTION screen appears. j Press > to select the Basal Rate Selection menu. 51 51639_00048010156_C.
4. j Press x or z to select the basal rate profile. The basal rate profile number and the basal rate total amount appear. j When the correct basal rate profile appears, press > to select it. For more information, see the pump User Guide. 52 51639_00048010156_C.
3 3.4 Managing Pump Errors, Warnings, and Reminders with the Meter If the meter is off when a pump error, warning, or reminder occurs and you turn on the meter, after communication to the pump is established: • The meter goes directly to the Pump screen. • Pump errors, warnings, and reminders appear on the meter screen. • You can mute or confirm the pump error, warning, or reminder on the meter or the pump. 53 51639_00048010156_C.
Cartridge Low Warning Cartridge Empty Error Follow the instructions in the pump User Guide for changing the insulin cartridge. When the contents of the insulin cartridge on the pump have dropped to 20 units of insulin, the pump warning W1: CARTRIDGE LOW appears. j When the warning appears on the meter Pump screen, press > twice to snooze and to confirm the warning. j Change the cartridge before it is empty. When the insulin cartridge is empty, the pump error E1: CARTRIDGE EMPTY appears.
4 4 Communication between the ACCU-CHEK Aviva Combo Meter and ACCU-CHEK Spirit Combo Pump 4.1 Overview 4.2 Turning Bluetooth® Wireless Technology On/Off 4.3 Using the System While Traveling 4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump 4.5 Cancelling the Pairing of the Meter and Pump Prompt 56 57 60 61 67 55 51639_00048010156_C.
4.1 Overview The meter and pump use Bluetooth wireless technology to communicate. If you are experiencing communication problems between the meter and pump, it is recommended you go directly to the pump and operate the pump manually. For more information on troubleshooting communication between the meter and pump, see Chapter 5, Troubleshooting. 56 51639_00048010156_C.
4 4.2 Turning Bluetooth Wireless Technology On/Off ® You may turn Bluetooth wireless technology on or off at any time using the meter. Bluetooth Wireless Technology Icon Communication States 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. 57 51639_00048010156_C.
Turning Pump Communication (Bluetooth Wireless Technology) On or Off Main Menu > Settings > Meter > Bluetooth 1. 2. 3. j From the Main Menu, select Settings and press =. j Select Meter and press =. j Select Bluetooth and press =. 58 51639_00048010156_C.
4. 4 NOTE • You cannot use the meter to disable Bluetooth wireless technology on the pump. You must manually turn off Bluetooth wireless technology on the pump. • If you change the pump time and date, the meter time and date will automatically synchronize to match the pump the next time communication is established. j Press and hold * until the Bluetooth icon changes. For instructions on how to turn on or turn off Bluetooth wireless technology on the pump, see the pump User Guide.
4.3 Using the System While Traveling When traveling on an aircraft, you must ensure Bluetooth wireless technology is turned off on the meter and on the pump prior to closure of the aircraft door. Electromagnetic emissions from the meter or pump could interfere with the electronics systems of the aircraft. 60 51639_00048010156_C.
4 4.4 Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump When obtained as a kit, the meter and pump are paired. If the meter and pump are not paired, see the following instructions. Pairing the Meter and Pump 1. 2. Pump: j Repeatedly press and release d until the BLUETOOTH SETTINGS screen appears. j Press f. Pump: j Ensure Bluetooth wireless technology is turned on. If turned off, press a to turn on. j Press d. 61 51639_00048010156_C.
3. 4. or Pump: j If the PAIRED DEVICE NONE screen appears, proceed to Step 6. Pump: j If the PAIRED DEVICE screen appears, press d and proceed to the next step. Pump: j To delete the device so the pump can be paired with another meter, press f. 62 51639_00048010156_C.
5. Pump: j Press f to confirm deletion of the paired device. 6. Pump: j Press d. 4 7. Meter: j Ensure the meter is turned off. j Press and hold * and then press +. 63 51639_00048010156_C.
8. 9. 10. Pump: j Press f to initiate the pairing process. Pump: j If NO DEVICE FOUND screen appears, see the pump User Guide for information on troubleshooting. j Select the meter to add. On the pump, press f. j Proceed to the next step for instructions on how to place the pump in pairing mode. j To discontinue setting up pairing, press +. 64 51639_00048010156_C.
11. 12. Pump: j The ADD DEVICE PAIRING screen appears followed by the ADD DEVICE ENTER PIN CODE screen. j Continue to the next step. Meter: The Pair with Pump screen appears. Enter the PIN Shown on the Pump Display: j Press =. j Set the first number and press =. Repeat until all of the numbers have been entered. 4 j Ensure the PIN entered matches the numbers on the pump screen. Select Confirm. 65 51639_00048010156_C.
13. NOTE Meter: j Turn off the meter. Once the meter has turned off, the pairing process is complete. You may turn on the meter and begin using it. • A blood glucose test cannot be performed during the pairing process. • The meter and pump remain paired when the batteries are removed and replaced. • Only one meter can be paired with one pump at a time. If the correct PIN was entered, this Pair with Pump screen appears on the meter, and the DEVICE PAIRED screen appears on the pump.
4 4.5 Cancelling the Pairing of the Meter and Pump Prompt If the meter and pump are not paired, the meter prompts you to complete the pairing process each time you turn on the meter unless you cancel the pairing process. 67 51639_00048010156_C.
1. 2. 3. j Turn on the meter. The Pairing setup has not been completed screen appears. j Select Cancel to cancel this pairing process prompt. Proceed to Step 2. j Or, to begin the pairing process select Next. Go to the section, Pairing the ACCU-CHEK Aviva Combo Meter with the ACCU-CHEK Spirit Combo Pump. j Select Yes to cancel the pairing process. Proceed to Step 3. j Or, select No and return to Step 1. If you selected Yes to cancel the pairing process, the Setup Completed Successfully screen appears.
5 5 Troubleshooting 5.1 Overview 5.2 Troubleshooting Communication Between the Meter and Pump 70 71 69 51639_00048010156_C.
5.1 Overview For most communication problems between the meter and pump, the meter displays a message with a short description of the symptom and, along with it, a proposed solution. This chapter goes into more detail by describing the symptom, the possible cause, and the possible solution. If the possible solutions do not fix the problem, contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578. For information about troubleshooting the standard meter features, see the Standard Owner’s Booklet.
5 5.2 Troubleshooting Communication Between the Meter and Pump Display Shows Bluetooth icon flashing Bolus Advice Bolus Advice data deleted Possible Cause(s) Possible Solution(s) 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 has Bluetooth wireless technology turned on. j Meter and pump are outside communication range. j Ensure the pump is within communication range.
Display Shows Possible Cause(s) Bolus Delivery Unavailable j The meter cannot communicate with the pump. j The pump is currently in Stop mode. Possible Solution(s) j Retry or set to Manual Pump. 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. j Take the pump out of Stop mode.
5 Display Shows Possible Cause(s) Possible Solution(s) Communication Lost j Pump is out of range of the meter. j Review or cancel the bolus on the pump. 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. Communication Warning j Communication of bolus data from the pump was not successful.
Display Shows Possible Cause(s) Connection Lost j The connection was lost between j Restart the pairing process. See the meter and the pump during the Chapter 4, Communication Between the pairing process. Therefore, the ACCU-CHEK Aviva Combo Meter and attempt to pair your meter and ACCU-CHEK Spirit Combo Pump. pump was unsuccessful. j Ensure the meter and pump have Bluetooth wireless technology turned on. j If the low battery icon is displayed on the meter, the meter cannot communicate with the pump.
5 Display Shows Possible Cause(s) Possible Solution(s) Infrequent Pump Communication j At least two weeks have passed since the meter and pump have communicated. j It is important to use Bluetooth wireless technology communication between the meter and pump regularly if you utilize bolus advice. j Ensure the meter and pump have Bluetooth wireless technology turned on. j Ensure the meter and pump are within communication range.
Display Shows Possible Cause(s) Possible Solution(s) Meter and Pump Not Paired j Meter and pump have not been j You must pair the meter and pump to use paired. You cannot use the pump these features. functions without pairing the meter j For instructions on how to pair the meter and the pump. and pump, see Chapter 4, Communication Between the ACCU-CHEK Aviva Combo Meter and ACCU-CHEK Spirit Combo Pump. Pairing Failed j The attempt to pair the meter and pump was unsuccessful.
5 Display Shows Possible Cause(s) Possible Solution(s) Pump Not Available j The pump is out of the j Ensure the meter and pump have communication range of the meter. 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. Time Mismatch j The time or date on the meter is more than 5 minutes different than the time or date on the pump.
WARNING If you are experiencing communication problems between your meter and pump, it is recommended you operate the pump manually and not use the meter to remotely control the pump. For assistance, please contact ACCU-CHEK Customer Care Service Center at 1-800-688-4578. NOTE For additional information on errors and warnings, see the Standard Owner’s Booklet. 78 51639_00048010156_C.
Appendices Appendix A: Bolus Advice Bolus advice is only available if you have set up bolus advice on the ACCU-CHEK Aviva Combo meter. For instructions on how to set up bolus advice, see the Standard Owner’s Booklet. Along with the basic blood glucose and carbohydrate values, there are several meter settings required to optimize the bolus advice feature so the recommendations match your insulin needs to the greatest possible extent. You must set up bolus advice correctly.
Bolus Advice Meter Settings This section contains an overview of the information that must be entered into the meter for accurate bolus advice recommendations. Carbohydrate Units • Bolus advice recommendations are based on the units of carbohydrates selected. • The right choice of carb units is important for bolus advice recommendations to be accurate. • Carbohydrate units must be selected, whether or not you set up bolus advice.
Warning Limits • You can select hyper (high) and hypo (low) blood glucose limits that best fit your needs. • Whenever a blood glucose test result is above the hyper warning limit or below the hypo warning limit, the meter displays a warning. • Set the hyper warning limit greater than the target range of all time blocks. • Set the hypo warning limit less than the target range of all time blocks. • Bolus advice is not available if your blood glucose test result is below the hypo warning limit.
Target Range • The desired upper and lower limits of your blood glucose level considered acceptable as set by your healthcare professional. • The meter automatically calculates the target blood glucose level as the average between the upper and lower blood glucose target limits. • Talk with your healthcare professional to determine the appropriate target range. Upper Blood Glucose Target Limit • The upper limit of the blood glucose target range for the current time block.
Insulin Sensitivity • For the current time block, the insulin sensitivity (correction factor) is the amount of insulin necessary to lower your blood glucose by a certain amount. • Talk with your healthcare professional to determine the appropriate insulin sensitivity settings. Your meter comes with the following preset time blocks: 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 83 51639_00048010156_C.
Talk to your healthcare professional about setting up time blocks to help you manage your diabetes. Here is a suggested pattern: Time Block Start Time End Time 1. Night time Midnight The time you normally wake up 2. Breakfast The time you normally wake up 1½ hours before you normally eat lunch 3. Lunch 1½ hours before you normally eat lunch 1½ hours before you normally eat dinner 4. Dinner 1½ hours before you normally eat dinner 1½ hours before you normally go to bed 5.
Setting Up Time Blocks: Important Information • Time blocks cover a 24-hour time period (from midnight to midnight). • You can change the time period for any of the preset time blocks. • When setting up bolus advice, you must complete and save the settings in at least one time block. • Each time block must be at least 30 minutes long and can only be set in 30-minute increments. • When you set the end time for a time block, the meter automatically sets this end time as the start time for the next time block.
Health events available on the meter are: • Exercise 1 • Exercise 2 • Stress • Illness • Premenstrual • Fasting Bolus Advice Options Meal rise, snack size, acting time, and offset time are bolus advice options. Below are detailed descriptions of each of these settings. Meal Rise • During or after meals, an increase in blood glucose levels is considered normal within a certain range, even though a meal bolus has been delivered. A meal rise is in effect for a specified time period.
Snack Size • The snack size is the amount of carbohydrates that is not to be counted as a regular meal with the expected meal rise. Acting Time • 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 target level. • You can adjust the length of the acting time to fit your individual needs, within a specified time interval (1½ hours to 8 hours).
Bolus Calculation The bolus recommended by the bolus advice feature of the meter consists of two components: a recommendation for a meal bolus that covers your food intake and a recommendation for a correction bolus to adjust your blood glucose level if it is not within the target range. The correction bolus can be positive if your current blood glucose level is above your target range or negative if it is below your target range.
Correction Bolus If your current blood glucose level is not within your target range, a correction bolus is recommended. Blood Glucose Limits bG Result Hyper Warning Upper Target Limit Target Lower Target Limit Hypo Warning Discuss your blood glucose limits with your healthcare professional. 51639_00048010156_C.
The calculation for the recommended correction bolus depends on your current blood glucose test result, your insulin sensitivity for the current time block, and whether you are planning to eat. Example Bolus Advice Calculations Blood Glucose Level Without Food Intake (No Carbs) Prior to a Meal Above Upper Target Limit (bG –Target bG) x Insulin Sensitivity (bG –Target bG) x Insulin Sensitivity + Meal Bolus Between Upper and Lower Target Limit No correction bolus is necessary.
Other Boluses Subsequent Meal Boluses If you are planning to eat several meals or snacks in a short period of time, you should administer a meal bolus for each meal. The calculation is always the same as a meal bolus. Correction Bolus After a Meal After a meal, it is normal to allow for a rise of your blood glucose level even if you administered the correct meal bolus. The allowed blood glucose level rise is called meal rise.
bG Level Hyper Acting Time Offset Time Meal Rise Target Value Target Range Hypo Current bG Values Time Meal Bolus Bolus Not Required Currently Allowed bG Value: Meal Rise The dotted line shows how your blood glucose level might change after a meal bolus. Bolus advice tolerates an increase in your blood glucose level within the meal rise range (green) without calculating an extra correction bolus.
Subsequent Correction Boluses The difference between your current blood glucose level and your target blood glucose level is called Delta bG. A correction bolus administered according to the previous conditions covers this difference for a certain period of time. As the correction bolus starts to take effect, your current blood glucose level should fall and the covered Delta bG decreases after the offset time. At the end of the acting time, your blood glucose level should return to the target limit.
Examples of Bolus Advice Recommendations The following graphs provide differing examples of how bolus advice considers different factors when calculations are made. The currently allowed blood glucose value considers the following factors: • Target Range Mean Value • Meal Rise • Correction Bolus 94 51639_00048010156_C.
After a Correction Bolus bG Level Hyper Acting Time Offset Time Corrected bG Target Value Target Range Hypo Current bG Values Time Bolus Bolus Not Required Currently Allowed bG Value: Corrected bG The above diagram shows an example of the effect of this rule. The first correction bolus at 12:00 pm remains active during the acting time (the width of the blue area).
bG Level Hyper Target Value Target Range Hypo Current bG Values Time Bolus When a blood glucose test result is greater than the currently allowed blood glucose value, a bolus is calculated (light blue) that only considers the difference between the current blood glucose value (orange dots) and the currently allowed blood glucose value (the top of the blue area). 96 51639_00048010156_C.
Acting Time bG Level Hyper Offset Time Meal Rise Target Value Target Range Hypo Current bG Values Time Meal Bolus Bolus Not Required Currently Allowed bG Value: Meal Rise Subsequent Meals If you eat several meals in a row, the meal rise is restarted for each new meal bolus. 97 51639_00048010156_C.
Appendix B: Bolus Advice Calculations The Mathematical Basis for Bolus Calculations The following is a list of the most important formulas and the calculation principles on which bolus advice is based. It is difficult to accurately calculate a bolus yourself using these formulas when the acting time and offset time of recent meals and correction boluses are considered. Carbohydrate Suggestion This calculation is made when the blood glucose test result falls below the hypo warning limit.
Meal Bolus The following formula is used to calculate the bolus for meals: Meal Bolus = Carbohydrate Intake × Insulin Carbohydrates from carbohydrate ratio Currently Allowed Blood Glucose Value The target range average value used in the calculation of the correction bolus, as shown below, changes with the definition for the time blocks.
Correction Bolus Generally, a correction bolus is only calculated if the current blood glucose value is above the hypo bG warning limit and outside the target range. If the current blood glucose value is above the target range, the currently allowed blood glucose value must also be exceeded. Only correction boluses greater than “0” trigger a corresponding acting time.
Correction Bolus with Carbohydrate Intake Whenever carbohydrates have been entered, the related meal bolus is always offset against any (even negative) correction bolus. When a meal is eaten, the correction bolus is also calculated for blood glucose test results that fall within the target range if: • The current blood glucose test result falls below the target range average value, or • The current blood glucose test result is above the currently allowed blood glucose value.
Appendix C: Explanation of Symbols You may encounter the following symbols on the packaging, on the type plate (back of meter), and in the instructions 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 102 51639_00048010156_C.
Appendix D: Limited License CAUTION A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK AVIVA COMBO SYSTEM—READ CAREFULLY THE LIMITATIONS RECITED BELOW. The ACCU-CHEK Aviva Combo system (meter, including the code key, and test strips) and its use are protected by U.S. Patent Nos.
Using the ACCU-CHEK Aviva Combo system indicates your acceptance of the restricted license to use the ACCU-CHEK Aviva Combo system only with ACCU-CHEK Aviva Plus test strips and the corresponding ACCU-CHEK Aviva Plus code key. If you do not agree to the terms and conditions of the restricted license, you may return, at 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.
WARNING A RESTRICTED LICENSE LIMITS USE OF THE ACCU-CHEK FASTCLIX SYSTEM (device and lancet drums). READ CAREFULLY THE LIMITATIONS RECITED BELOW. The ACCU-CHEK FastClix system (device and lancet drums) and its use are protected by U.S. Patent Nos. 7,322,998 (expires 3-March-2020) and 7,785,338 (expires 5-January-2026).
Using the ACCU-CHEK FastClix device indicates your acceptance of the restricted license to use the ACCU-CHEK FastClix device only with ACCU-CHEK FastClix lancet drums. If you do not agree to the terms and conditions of the restricted license, 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.
Index A acting time, 87 active insulin, 87 aircraft.
C carbohydrate units, 80 carb ratio, 82 carbs amount, 14 cartridge, empty, 54 low, 54 communication, meter and pump, overview, 34–37, 56 troubleshooting, 71–78 correction bolus, 91–93 D deliver a bolus.
O offset time, 87 P pairing, delete device, 62 pairing meter with pump, 61–66 pairing prompt, cancelling, 67–68 pen bolus, description, 28 PIN, enter into meter, 65 pump control using meter, 38–40 pump screens on meter, features, 41–42 S safety information, bolus advice, 10–12 bolus delivery, 22–23, 29 snack size, 87 standard bolus, cancel programmed meter delivery, 45–46 delivery using bolus advice, 15–16 description, 27 program delivery through meter, 43–44, 47, 51 symbols, explanation, 102 synchronize,
T target range, 82 temporary basal rate (TBR), cancel programmed TBR, 50 program through meter, 47–49 time blocks, 81, 83–85 troubleshooting. See communication, meter and pump, troubleshooting U upper blood sugar target limit, 82 W warning limits, 81 warnings, pump, 53–54 warranty. See Standard Owner’s Booklet for ACCU-CHEK Aviva Combo Blood Glucose Meter 110 51639_00048010156_C.
111 51639_00048010156_C.
112 51639_00048010156_C.
LAST UPDATE: 2012-08 51639_00048010156_C.
Aviva Combo 00048010156/C-0613 This file may not print or view at 100%. Die lines and color breaks do not print. ©2013 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 51639_00048010156_C.indb 1 ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and FASTCLIX are trademarks of Roche.
