05071739002-0809 Accu-Chek Aviva Combo Aviva Combo Blood SUGAR Meter Standard Owner’s Booklet ©2009 Roche Diagnostics. All rights reserved. Assembled in USA. Distributed by: Disetronic Medical Systems Inc. 11800 Exit 5 Parkway, Suite 120 Fishers, IN 46037 Phone 866-703-3476 Fax 888-810-0758 ACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA COMBO, ACCU-CHEK SPIRIT COMBO, and ACCU-CHEK MULTICLIX are trademarks of Roche. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
Aspects of the ACCU-CHEK Aviva Combo system, including the meter, code key, and test strips, and their use, are covered by one or more of the following United States patents: 5,352,351; 4,999,582; 5,997,817; 5,053,199; Re. 36,268; 5,438,271; 5,366,609; 6,645,368; 6,662,439; 5,122,244; 7,073,246; 7,276,146; 7,276,147; 7,338,639; 7,386,937; 7,407,811; 7,452,457; 7,488,601; 7,494,816; 7,556,723; 7,569,126. Additional United States Patents pending.
Before You Start Testing 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. • Set the time and date on your meter before you begin testing.
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 or forearm). • Only use ACCU‑CHEK Aviva 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 w WARNING: Certain substances can interfere with the ACCU‑CHEK Aviva Combo blood glucose system and cause falsely high results. For example, peritoneal dialysis solutions containing icodextrin (such as Extraneal) or certain immunoglobulin therapies that contain maltose (such as Octagam 5 %) cause inaccurate results. For more information, refer to the Test Strip Package Insert or ask your healthcare professional.
• 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 7 8 The ACCU‑CHEK Aviva Combo System 1 Understanding Your New System 1.2 The ACCU‑CHEK Aviva Combo Meter at a Glance 1.3 The ACCU‑CHEK Spirit Combo Insulin Pump at a Glance 1.4 Summary of Features 1.5 Screen Content and Navigation 2 Testing Your Blood Sugar 2.1 Overview 2.2 Coding Your Meter 2.3 Using the ACCU‑CHEK Aviva Combo System 2.
2.5 Detailed Blood Sugar Results 2.6 Understanding Blood Sugar Test Results 2.7 Unusual Test Results 2.8 Symptoms of High or Low Blood Sugar 52 56 60 62 3 Control Testing 65 66 67 68 69 75 3.1 Overview 3.2 Why Perform Control Tests 3.3 About the Control Solutions 3.4 Performing a Control Test 3.5 Understanding Control Test Results 4 Managing Your Data 4.1 Overview 4.2 Viewing or Modifying Your Data 4.3 Adding New Data 4.4 Reporting Your Data 4.
5 Changing Meter Settings 5.1 Overview 5.2 Setting bG Test Reminders: After High bG, After Low bG, After Meal 5.3 Setting Alarm Clock Reminders: bG Test, Other 5.4 Setting Date Reminders: Dr. Visit, Lab Test, Infusion Set Change 5.5 Setting Bolus Advice for the First Time 5.6 Setting Time Blocks, Health Events, Advice Options: Bolus Advice Set Up 5.7 Setting Warning Limits: Hyper, Hypo 5.8 Turning Key Lock On or Off 5.9 Setting the Language 5.10 Setting Units: Carbs 5.
6 Icons, Reminders, Warnings, and Errors 6.1 Overview 6.2 List of Icons 6.3 Confirming a Reminder, Warning, or Error 6.4 List of Reminders 6.5 List of Warnings 6.6 List of Errors 7 Care and Maintenance 7.1 Overview 7.2 Changing the Batteries 7.3 Power-Saving Tips 7.4 Cleaning the Meter 7.5 Maintenance and Testing 8 Troubleshooting 8.1 Overview 8.
9 Technical Information 9.1 Overview 9.2 Product Limitations 9.3 Specifications 9.4 Product Safety Information 9.5 Disposing of the Meter, Strips, Lancets, and Batteries 9.6 Warranty 9.7 Additional Supplies 9.
6
Introduction Whether the ACCU‑CHEK Aviva Combo meter is your first blood sugar 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.
The ACCU‑CHEK Aviva Combo System The ACCU‑CHEK Aviva Combo meter is for quantitative blood sugar testing using ACCU‑CHEK Aviva test strips.
i NOTE: Blood sugar and bG are interchangeable and mean the same thing. Intended Use The ACCU‑CHEK Aviva Combo blood glucose monitoring system is intended for the quantitative measurement of blood glucose. The ACCU‑CHEK Aviva Combo system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes and/or by professionals in a clinical setting as an aid to effective diabetes management.
The system includes: • ACCU‑CHEK Aviva Combo meter with three AAA batteries (already inserted) • ACCU‑CHEK Aviva test strips and code key • ACCU‑CHEK Aviva control solution w WARNING: Any object coming into contact with human blood is a potential source of infection (see: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline – Third Edition; CLSI document M29-A3, 2005).
1 1 Understanding Your New System 1.1 Overview 1.2 The ACCU‑CHEK Aviva Combo Meter at a Glance 1.3 The ACCU‑CHEK Spirit Combo Insulin Pump at a Glance 1.4 Summary of Features 1.
1.1 Overview Your new meter has several features to assist you in managing your diabetes. It is important you understand the features and how to operate the meter correctly. i NOTES: • 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 Pump Support at 1‑800‑688‑4578. • On the meter display, the code chip is referred to as a code key.
1 1.2 The ACCU‑CHEK Aviva Combo Meter at a Glance Infrared (IR) Window Display Transfers data from the meter to a computer. Shows menus, results, messages, and data stored in the diary. Code Key Slot Buttons Insert code key here with code number facing away from you. Press to enter menus or the diary, adjust settings, and scroll through results. Battery Door Left/Right Soft Keys Remove the battery door by pushing the tab and pulling the door up. Press to select the menu or option above the key.
Top View Batteries (for example) Insert batteries according to the + and - symbols in the battery compartment. Test Strip Test Strip Container Control Solution Bottle Yellow Window - Touch blood drop or control solution here. Golden End - Insert this end of the test strip into the meter.
1 The meter has seven buttons and two soft keys. Left Soft Key Right Soft Key Up Arrow Right Arrow Enter Down Arrow Left Arrow Backlight Power On/Off i NOTES: • You hear a sound every time an active button/soft key is pressed 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 press ..
Table of Buttons and Soft Keys Button < > x z , . = 16 Name Function Left Arrow j Move or scroll to the left in a screen. Right Arrow j Move or scroll to the right in a screen. Up Arrow j Move or scroll up in a screen. Down Arrow j Move or scroll down 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.
1 Table of Button Combinations Button Combination Name Function 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 Meter/Pump * and then press +. Pairing j Begins meter and pump pairing.
1.3 T he ACCU‑CHEK Spirit Combo Insulin Pump at a Glance Up Key Menu 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. Cycles through menus, functions, and information screens. OK Key Selects current settings displayed on screen, saves changes, exits a screen, and allows the user to view the QUICK INFO screen. Display Shows menus, messages, and data stored in the pump memory.
1 1.4 Summary of Features Display The meter has a full-color graphic LCD (Liquid Crystal Display) that displays current and historical information. Backlight • The backlight helps you read the information on the meter display under different lighting conditions. • When the meter is turned on, the backlight is set to the medium level. • Adjust the backlight level by pressing and releasing the backlight button. • The backlight adjusts from low, to medium, to high, and back to low again.
Key Lock • The key lock feature allows you to lock all of the buttons on the meter, except for the power on/off button. • The key lock serves as a safety measure against unintentional activation of meter functions. • For more information, see Chapter 5, “Changing Meter Settings.” Signal Settings • The meter communicates reminders, warnings, and errors using sounds and vibrations. • For more information, see Chapter 6, “Icons, Reminders, Warnings, and Errors.
Bolus Advice (Optional) 1 • The term “bolus” refers to the delivery of insulin all at once rather than slowly throughout the day, usually used to compensate for meals or high blood sugar. • Bolus advice calculates a bolus for you that is adapted to the time of day and your changing situations. • This function is activated only if you set up bolus advice on the meter. • For instructions on how to set up bolus advice, see Chapter 5, “Changing Meter Settings.
Administering a Bolus Using your new meter, you can deliver a bolus: • Remotely on your pump using Bluetooth wireless technology • Using the bolus advice feature of the meter • Independently on your pump • Using an insulin pen or 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 sugar test averages, trends, standard day, standard week, and target tables and graphs of the data in the diary.
Data Transfer • You can transfer your data stored on the meter to a computer. • For more information, see Chapter 4, “Managing Your Data.” 1 Warning Limits for Hypo and Hyper Blood Sugar Levels • You can select hypo (low) and hyper (high) blood sugar limits that best fit your needs. Whenever a blood sugar 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 sugar test results.
Time Blocks • Time blocks allow you to divide a day into different time periods. • Setting time blocks to fit your own schedule helps you and your healthcare professional see how patterns in your blood sugar 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 five default time blocks.
Without bolus advice, you need to consider the following when setting up time blocks: • Determine the appropriate time range by reviewing the end time for each time block. • Review the acceptable blood sugar target range (low and high) for each time block. 1 With bolus advice, you need to consider the following when setting up time blocks: • Determine the appropriate time range by reviewing the end time for each time block.
Health Events Health events can be selected to indicate how you are feeling or what you are doing that might affect your diabetes. The meter allows you the option of setting a percentage for each health event if you set up bolus advice. Health events available on the meter are: • Fasting • Exercise 1 • Stress • Illness • Exercise 2 • Premenstrual Fasting does not scale bolus advice calculations and is not adjustable. Discuss the appropriate percentage for each health event with your healthcare professional.
Blood Sugar Test Reminders (Optional) 1 The meter can be set up to remind you to retest your blood sugar after a high blood sugar test result, after a low blood sugar test result, or after a meal. An after high blood sugar test reminder example: • The meter is set up with a high bG threshold level of 240 mg/dL and with a reminder time of 60 minutes. • You have a blood sugar test result higher than 240 mg/dL, perhaps 270 mg/dL. • In 60 minutes, the meter reminds you to perform another blood sugar test.
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.” Alarm Clock Reminders • The meter has alarm clock reminders which can be used as a helpful way to remind you when to test throughout the day. • In addition to “bG Test,” you can set reminders for “Other” for any other daily reminder. • You can set up to eight reminders per day.
1 1.5 Screen Content and Navigation This section 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.
Features on the Main Menu: Sound Icon Appears when the beeper is turned on. Time Menu Options Vibrate Icon 10:02 am bG Test Bolus Advice Pump My Data Settings 2 Feb 08 Appears when vibrate is turned on. Date Low Battery Icon Appears when the meter batteries are low. Bluetooth Wireless Technology Icon Indicates whether the Bluetooth wireless technology is on, off, or connecting. i NOTES: • To select an item on a menu, press x or z to highlight (blue) the menu item and then press =.
Bluetooth Wireless Technology Icon Communication States 1 You may turn Bluetooth wireless technology on or off at any time 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.
Connecting to the Pump screen during pairing: Connecting to the Pump This screen appears when Bluetooth wireless technology is on and the meter is connecting to the pump.
1 Features on a screen: Title Bar Primary menu title is displayed here. Secondary Title Bar When necessary, a secondary title bar appears. Secondary menu text is displayed here. Left Soft Key Option Press , to select the option above the button on the screen. View Data 2 Feb 08 69 8:06 pm 126 5:33 pm 4:06 pm 154 1:52 pm 60 9:03 am 397 Back Select View Highlighted Option When a menu choice or item is selected, it is highlighted in blue.
Information can be entered on some screens. Numerical entry fields appear as pop-up entry fields. When an option must 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.
1 General Navigation Steps To change the settings or enter information into the meter: 1. 10:02 am bG Test Bolus Advice Pump My Data Settings 2 Feb 08 10:02 am Reminders Bolus Advice Meter Sound/Vibrate Time/Date Time Blocks Menu 2 Feb 08 Start 12:00 am 5:30 am 11:00 am 5:00 pm 9:30 pm Back Time Blocks End 5:30 am 11:00 am 5:00 pm 9:30 pm 12:00 am j Press x or z to select a menu option and press =. j Repeat the previous step as necessary.
2. 3. 4. Time Blocks Time Blocks 12:00 am Target Range 70 mg/dL Cancel 5:30 am 140 mg/dL Save j Press x or z or < or > to select an option or a desired entry field and press =. 36 5:30 am 5:30 am 12:00 am Target Range 70 mg/dL 140 mg/dL Cancel j Press x or z to select the desired entry and press =. j Repeat Steps 2 and 3, as necessary. j Select Save by pressing . to save changes and return to the previous screen.
7 7 Care and Maintenance 7.1 Overview 7.2 Changing the Batteries 7.3 Power-Saving Tips 7.4 Cleaning the Meter 7.
7.1 Overview It is important to properly 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 Pump Support at 1‑800‑688‑4578.
7 7.2 Changing the Batteries 1. 2. 3. j Remove the battery door from the back of the meter by pushing the tab in the direction of the arrow and pulling the door up. j Remove the old batteries from the meter. j Insert three AAA batteries with the + and - ends matching the marks in the battery compartment. j Put the battery door back in place and snap it closed.
c CAUTIONS: • Using batteries other than those supplied or recommended for use with the meter may significantly reduce the life of the batteries. Batteries other than those recommended may leak and corrode the battery contacts within the meter. Using batteries not supplied 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.
7 i NOTES: • Alkaline batteries are recommended for use with the meter. • After you change the batteries, the meter prompts you to confirm the time and date settings. • It is a good idea to have spare, packaged batteries available. • All test results, diary information, and settings are saved in the meter memory when the batteries are replaced. • The meter remains paired with the pump when you remove and replace the batteries. • Rechargeable batteries may be used in the meter.
7.
7 7.4 Cleaning the Meter Caring for the meter is easy: just keep it free of dust.
7.5 Maintenance and Testing • The meter needs little or no maintenance with normal use. It automatically tests its own systems every time you turn it on and lets you know if something is wrong. For detailed information on troubleshooting the meter, see Chapter 8, “Troubleshooting.” • If you drop the meter or think it is not giving accurate results, ensure 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.
8 8 Troubleshooting 8.1 Overview 8.
8.1 Overview For most problems, 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 Pump Support at 1‑800‑688‑4578. w WARNING: Never make treatment decisions based on a warning or error message. If you have any concerns, contact ACCU‑CHEK Pump Support at 1‑800‑688‑4578.
8 8.2 T roubleshooting the ACCU‑CHEK Aviva Combo Meter Display Shows Possible Cause(s) The display is j Batteries are dead. blank or the meter will not turn on. jD isplay is damaged. Bluetooth icon flashing Possible Solution(s) j Install new batteries. See Chapter 7, “Care and Maintenance.” j Contact ACCU‑CHEK Pump Support at 1‑800‑688‑4578. j Meter is defective. j Contact ACCU‑CHEK Pump Support at 1‑800‑688‑4578. j Extreme temperature – the temperature is outside the meter operating range.
238 Display Shows Possible Cause(s) Possible Solution(s) Above Hyper Warning Limit j Your test result is above the j Treat your high blood sugar as recommended by hyper warning limit set in the your healthcare professional. meter. j Consider checking bG, ketones, and insulin. j See the pump User Guide for additional solutions. 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.
Display Shows Possible Cause(s) Possible Solution(s) Bolus Advice j Bolus advice data integrity cannot be confirmed. j Wait 8 hours for accurate bolus advice. Bolus Advice data deleted Bolus Advice Not Setup Bolus Advice Timeout 8 IMPORTANT: • Insulin doses and meals taken before the Bolus Advice warning are no longer reflected in the bolus advice calculation. • The meter may not reflect the pump bolus history, however the bolus history is available on the pump.
Display Shows Possible Cause(s) Possible Solution(s) Bolus Delivery Unavailable j The meter cannot j Retry or set to Manual Pump. communicate with 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. j The pump is currently in Stop j Take the pump out of Stop mode. mode.
Display Shows Possible Cause(s) Possible Solution(s) 8 Carbohydrate Ratio j Carbohydrate ratio is outside j Check your entries and contact your healthcare of the acceptable meter professional to determine the appropriate settings. range. Code Key Missing j The meter is not coded or the j Turn off the meter and recode it. See Chapter 2, code key is not inserted. “Testing Your Blood Sugar.” Communication Lost j Pump is out of range of the meter. j Bolus delivery continuing, see pump screen.
242 Display Shows Possible Cause(s) Possible Solution(s) Communication Warning j Communication of bolus data j Ensure the meter and pump have Bluetooth wireless from the pump was not technology turned on. successful. Therefore, pump j Ensure the meter and pump are within data are not available and the communication range. bolus data may not be j If the low battery icon is displayed on the meter, the accurate. meter cannot communicate with the pump.
Display Shows Possible Cause(s) Possible Solution(s) Connection Lost j The connection was lost j Restart the pairing process. See the Advanced between the meter and the Owner’s Booklet. pump during the pairing j Ensure the meter and pump have Bluetooth wireless process. Therefore, the technology turned on. attempt to pair the meter and j If the low battery icon is displayed on the meter, the pump was unsuccessful. meter cannot communicate with the pump. Replace the batteries.
Display Shows Possible Cause(s) Possible Solution(s) E-51 Bad Strip Error j Your blood sugar may be extremely low. j If you see this error message after you applied blood to the test strip, see Chapter 2, “Testing Your Blood Sugar.” j The test strip is damaged. j The test strip is not properly inserted into the meter. j If you see this error message before you applied blood to the test strip, remove the test strip and reinsert it, or replace it if damaged.
Display Shows Possible Cause(s) E-53 Bad Test Error j A meter or test strip error has j Discard the test strip and repeat the test. occurred. j Your blood sugar may be extremely high. Possible Solution(s) 8 j If this confirms how you feel, contact your healthcare professional immediately. If it does not confirm how you feel, repeat the test and see Chapter 2, “Testing Your Blood Sugar.
246 Display Shows Possible Cause(s) Possible Solution(s) E-54 Not Enough Sample j Not enough blood or control j Discard the test strip and repeat the test. solution was drawn into the test strip for measurement or was applied after the test has started. E-55 Code Key Expired j The code key is from an expired lot of test strips. E-56 Sample Applied Early j Blood or control solution was j Discard the test strip and repeat the test with a new applied to the test strip before test strip.
Display Shows Possible Cause(s) Possible Solution(s) E-57 Electronic Error j An electronic error has occurred or, in rare cases, a used test strip was removed and reinserted. j Turn off the meter and remove the batteries. Wait at least 30 seconds prior to reinserting the batteries. Turn on the meter and perform a blood sugar or control test. If the problem persists, contact ACCU‑CHEK Pump Support at 1‑800‑688‑4578. E-58 Temp.
248 Display Shows Possible Cause(s) Possible Solution(s) HI bG Warning j Your blood sugar may be higher than the measuring range of the system. j If you are experiencing any of the common symptoms of high blood sugar, contact your healthcare professional immediately. j Treat your high blood sugar as recommended by your healthcare professional. j Consider checking bG, ketones, and insulin. j See the pump User Guide for additional solutions. Incorrect Pump Time/Date j Pump time/date incorrect.
Display Shows Possible Cause(s) Possible Solution(s) Insulin Sensitivity j Insulin sensitivity is outside of j Check your entries and contact your healthcare the acceptable meter range. professional to determine the appropriate settings. Invalid Bolus Advice Times j The acting time value is less than the offset time. j The acting time value must be set equal to or greater than the offset time. Reset the acting time value or revise the offset time.
Display Shows 250 Possible Cause(s) Possible Solution(s) Invalid Hypo Values j The hypo warning limit value must be less than all of your target ranges in the time block settings. j Reset the hypo warning limit or revise the target ranges in time blocks and re-enter the hypo warning limit. j Enter a hypo warning limit that is below the target ranges of your time blocks. See Chapter 5, “Changing Meter Settings.” Invalid PIN j The wrong PIN was entered.
Display Shows Possible Cause(s) Possible Solution(s) Invalid Target Range j The lower target range value is above the upper target range value. j Reset the target range values. j Enter the correct lower target range value and 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.
Display Shows Possible Cause(s) Possible Solution(s) Meter and Pump Not Paired j Meter and pump have not been paired. You cannot use the pump functions without pairing the meter and the pump. j You must pair the meter and pump to use these features. j For instructions on how to pair the meter and pump, see the Advanced Owner’s Booklet. Meter Battery Low j Battery power is low. 252 j Install new batteries. See Chapter 7, “Care and Maintenance.
Display Shows Possible Cause(s) Possible Solution(s) Pump Not Available j The pump is out of the communication range of the meter. 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, the meter cannot communicate with the pump. Replace the batteries. Test Strips Expiring j The test strips expire at the end of the current month.
Display Shows Possible Cause(s) Possible Solution(s) Time Mismatch j The time or date on the meter j The meter time and date were changed to match is more than five minutes the pump time. Ensure the time and date are different than the time or date correct. If the time or date are not correct, change on the pump. the time and date on the pump. i NOTES: • For additional information on errors and warnings, see Chapter 6, “Icons, Reminders, Warnings, and Errors.
9 9 Technical Information 9.1 Overview 9.2 Product Limitations 9.3 Specifications 9.4 Product Safety Information 9.5 Disposing of the Meter, Strips, Lancets, and Batteries 9.6 Warranty 9.7 Additional Supplies 9.
9.1 Overview This chapter provides you with important performance information regarding the meter.
9 9.2 Product Limitations Please read the literature packaged with your test strips to find the latest information on product specifications and limitations.
9.3 Specifications 258 Blood volume j Refer to the test strip package insert. Sample type j Fresh whole blood Measuring time j Refer to the test strip package insert. Measuring range j Refer to the test strip package insert. Test strip storage conditions j Refer to the test strip package insert. Meter storage conditions (with batteries inserted) j -4 °F to 122 °F System operating conditions j Refer to the test strip package insert.
Power supply j Three AAA batteries (recommended: alkaline) Display j LCD Dimensions j 3.7 x 2.1 x 1 inches (LWH) Weight j Approximately 3.6 oz with batteries inserted Construction j Hand-held Protection class j III Meter type j The ACCU‑CHEK Aviva Combo meter is suitable for continuous operation.
9.4 Product Safety Information Bluetooth Wireless Technology The meter and the pump utilize Bluetooth wireless technology to communicate and transfer information. Bluetooth wireless technology is a form of radio frequency (RF) technology that operates in the unlicensed industrial, scientific, and medical band at 2.4 to 2.485 GHz. The RF channel utilized for communication between the meter and the pump is not an open channel.
In the event there is interference from another device, it is recommended that you increase distance between meter and that device. You may also turn off the interfering device. In addition, you may turn off Bluetooth wireless technology on the meter and deliver insulin directly using the pump. 9 Changes or modifications to the device not expressly approved by Roche could void the user’s authority to operate the device.
Performance Analysis The performance data for the ACCU‑CHEK Aviva Combo system (ACCU‑CHEK Aviva Combo meter with ACCU‑CHEK Aviva test strips) were obtained using capillary blood from diabetic patients (method comparison, accuracy), venous blood (repeatability), and control solution (reproducibility). The system is calibrated with venous blood containing various levels of sugar. The reference values are obtained using the hexokinase method.
9 9.5 Disposing of the Meter, Strips, Lancets, and Batteries w warningS: • Any product coming in contact with blood is considered contaminated (potentially infectious).* • During normal testing any blood sugar meter may come in contact with blood. Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions.
• Decontaminate the meter before recycling or disposing. Wipe the outside of the meter with a dilution of bleach solution, one part bleach to nine parts water. • Users in professional environments (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.
9 9.6 Warranty ACCU‑CHEK Aviva Combo Meter Limited 4-Year Warranty Disetronic Medical Systems Inc., a member of the Roche Group warrants to the original purchaser of the meter that your ACCU‑CHEK Aviva Combo meter will be free from defects in materials and workmanship for 4 years from the date of purchase.
THE PRECEDING WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND DISETRONIC MEDICAL SYSTEMS MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL DISETRONIC MEDICAL SYSTEMS BE LIABLE TO THE PURCHASER OR ANY OTHER PERSON FOR ANY INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR PUNITIVE DAMAGES ARISING FROM OR IN ANY WAY CONNECTED WITH THE PURCHASE OR OPERATION OF THE METER OR ITS PARTS.
Warranty Instructions 9 All requests for return of ACCU‑CHEK Aviva Combo meters under the preceding warranty must be made to ACCU‑CHEK Pump Support. You will be mailed a return authorization label, which must be affixed to your carton for shipping the system to Disetronic Medical Systems. Cartons received without this label will be returned to you at your expense. Customers experiencing difficulties should review the troubleshooting information in Chapter 8 of this booklet.
Limited License c 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. 6,645,368; 5,366,609; 5,352,351; 5,053,199; 5,122,244; 7,276,146; 7,276,147; and Re. 36,268.
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 test strips and the ACCU‑CHEK Aviva code key. Further, if you have purchased an ACCU‑CHEK Aviva Combo monitoring kit or an ACCU‑CHEK Aviva Combo meter that includes this restricted license, then this restricted license applies regardless of any additional offers found in ACCU‑CHEK Aviva test strip packages.
c CAUTION: A RESTRICTED LICENSE LIMITS USE OF THE ACCU‑CHEK MULTICLIX DEVICE (lancet driver and lancets). READ CAREFULLY THE LIMITATIONS RECITED BELOW. The ACCU‑CHEK Multiclix device and its use are protected by U.S. Patent Nos. 4,924,879; Re. 35,803; 6,419,661. A license to use the ACCU‑CHEK Multiclix device is only granted when ACCU‑CHEK Multiclix lancet drums are used with the ACCU‑CHEK Multiclix device.
Using the ACCU‑CHEK Multiclix device indicates your acceptance of the restricted license to use the ACCU‑CHEK Multiclix device only with ACCU‑CHEK Multiclix lancet drums. Further, if you have purchased an ACCU‑CHEK Multiclix device that includes this restricted license, then this restricted license applies regardless of any additional offers found in ACCU‑CHEK Multiclix device packages.
9.
9 9.8 Information for Healthcare Professionals w warning: Healthcare Professionals: Follow the infection control procedures appropriate for your facility. A drop of fresh, whole blood is required to perform a blood sugar test. Refer to the test strip package insert for additional healthcare professional information.
Recommending Alternative Site Testing to Patients Decisions about whether to recommend alternative site testing (AST) should take into account the motivation and knowledge level of the patient and his or her ability to understand the considerations relative to diabetes and AST. If you are considering recommending AST for your patients, you need to understand that there is a potential for a significant difference between fingertip and alternative site blood sugar test results.
Appendices Appendix A: Abbreviations Abbreviation Definition AM j Ante Meridiem (12-hour clock notation for “before noon”) AST j Alternative Site Testing BE j Bread Equivalent (equal to 12 grams of carbohydrates) bG j Blood Sugar Carbs j Carbohydrates CC j Carbohydrate Choice (equal to 15 grams of carbohydrates) °F j Degrees Fahrenheit FCC j Federal Communications Commission (United States) g j Grams GHz j Gigahertz 275
276 Abbreviation Definition Hyper j Hyperglycemia (high blood sugar) Hypo j Hypoglycemia (low blood sugar) IR j Infrared ISO j International Organization for Standardization KE j Kohlenhydrateinheit (equal to 10 grams of carbohydrates) LCD j Liquid Crystal Display mg/dL j Milligrams per Deciliter N/A j Not Applicable NIST j National Institute of Standards and Technology (United States) PIN j Personal Identification Number PM j Post Meridiem (12-hour clock notation for “after noon”)
Abbreviation Definition SD j Standard Deviation U j Units (bolus insulin units) 277
Appendix B: Carb Units For carbohydrates, the following units of measure are available on the meter. Abbreviation Unit of Measurement Gram Equivalent g j Grams* j 1 gram KE j Kohlenhydrateinheit j 10 grams BE j Bread Equivalent j 12 grams CC j Carbohydrate Choice j 15 grams *Standard unit of measure in the U.S.
Appendix C: Explanation of Symbols You may encounter the following symbols on the packaging, on the type plate, and in the instructions for the meter, shown here with their meaning. w j Warning (refer to accompanying documents). Please refer to safety-related notes in the owner’s booklets accompanying this instrument. c j Caution (refer to accompanying documents). Please refer to safety-related notes in the owner’s booklets accompanying this instrument.
Appendix D: Meter Settings and Range Limits mg/dL 280 Data Type Unit of Measurement MIN MAX Increments Default Setting Acting Time hours:minutes 1:30 8:00 0:15 4:00 Active Insulin Units 0 99.9 0.1 No entry (“--- u”) bG Threshold (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.
Data Type Unit of Measurement MIN MAX Increments Default Setting Exercise 1 (health event) % -50 50 1 0 Exercise 2 (health event) % -50 50 1 0 Extended Bolus (insulin) Units 0 501 0.1 No entry (“--- u”) 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.
Data Type Unit of Measurement MIN MAX Increments Default Setting Offset Time hours:minutes 0:45 Acting 0:15 Time 1:00 Premenstrual (health event) % -50 50 1 0 Snack Size (carbs) grams BE KE CC 0 0 0 0 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.
The following are the default settings for bG test reminders. To turn on a bG test reminder, see “Setting Alarm Clock Reminders: bG Test, Other” in Chapter 5, “Changing Meter Settings.
The following are the default settings for the time blocks. Talk to your healthcare professional about setting up time blocks to help you manage your diabetes. To adjust the time blocks, see Chapter 5, “Changing Meter Settings.
Glossary Term Definition 7-day average j Includes results generated today and the previous 6 days. Acting Time j The period of time from the start of the meal rise or the delivery of a correction bolus until your blood sugar level is expected to return to the target level. Active Insulin j Bolus insulin that has been given to lower your blood sugar but has not yet been fully used.
286 Term Definition After Meal Reminder j A reminder to retest your blood sugar. When enabled, this reminder occurs after a meal. For this reminder to occur, you must enter carbohydrate data greater than the snack size amount. Alarm j Audible or vibrating (silent) notification indicating a reminder, warning, or error. Alternative Site Testing (AST) j Blood sugar test from another place on your body besides the fingertip.
Term Definition Bolus Advice j When enabled, bolus advice provides recommendations on the amount of insulin for food intake and for correcting blood sugar levels that are not within your target range. Bolus Advice Options j See Advice Options. Bolus Delivery Start Delay j The Standard Bolus icon blinks for five seconds and then the meter communicates to the pump to begin delivery of the bolus amount. During this delay you are able to cancel the bolus delivery by pressing x or z.
288 Term Definition Control Result j Value displayed on meter as the result of a control test. When the Control Result is within the range shown on the label of the test strip container, then the test strips and the meter are working properly. Control Test j A meter test using control solution which lets you know that the meter and test strips are working properly. Corrupt Result j bG test result that had an error.
Term Definition End Time j The end time of a time block. Extended Bolus j A bolus delivered over a period of time. It can be helpful during long meals or when you have meals that are digested slowly. The Extended Bolus may also be appropriate 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.
290 Term Definition Hypo j Hypoglycemia: an abnormally low level of sugar in the blood. Hypo Warning Limit j When your blood sugar test result is below the hypo warning limit, a warning is displayed. Insulin Pump j A device that delivers a continuous supply of insulin into the body. Insulin Sensitivity j The amount of insulin necessary to lower your blood sugar by a certain amount. Ketones j A by-product or waste product when your body burns stored fat for energy.
Term Definition LO j The test result is below the meter’s measurement range. Meal Rise j During or after meals, an increase in blood sugar 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. Meal Time j A pop-up menu selection (pre-meal, post-meal, bedtime, or other) that allows information to be stored with a blood sugar test or in a diary record. Meter j Blood sugar meter.
292 Term Definition Offset Time j Offset time takes into account the expected delay for the blood sugar level to actually fall during the acting time of insulin in the body. It describes the first time period within the acting time. Paired j A pump and meter exclusively communicating and transferring information with each other. Pump j See Insulin Pump. Quick Bolus j A bolus delivery on the pump using the pump UP and DOWN keys. One key press equals one bolus increment (i.e., 0.1, 0.2, 0.5, 1.
Term Definition Snack Size j The amount of carbohydrates that is not to be counted as a regular meal with the expected meal rise. Snooze j Delay of some reminders for a defined time period. Soft Keys j Two buttons under the meter display used to navigate through the user interface. Just above each soft key, the meter display shows the selection (i.e., Save, Cancel, Back, etc.). Standard Bolus j A bolus that is immediately delivered to cover a food or a blood sugar correction.
294 Term Definition Target Range j The range of your blood sugar results considered acceptable when you are fasting. Time Blocks j Up to eight time periods within one day to facilitate your changing insulin needs throughout the day. Time Range j The user sets the duration of time. There is a start and end time. User j A person using the meter or pump. Warning j Describes items and conditions that present hazards and may cause personal injury.
Index A abbreviations, 275–277 acting time, 160–162, 171 active insulin, 52–55 advice options, 170–171 after high bG test reminder, 141–145, 208, 210, 212 after low bG test reminder, 141–145, 208, 211–212 after meal bG test reminder, 141–145, 208–209, 212, 215 alarm clock reminders, bG test, 28, 146–148, 212, 216 other, 28, 146–148, 212, 216–217 alternative site test, description, 44 performing, 43–51 appetite, increased, 62 B backlight, 19, 201–202 button, 13, 16–17 batteries, changing, 229–231 low, 30 ty
Bluetooth wireless technology, 260–261 turning on or off, 16, 31, 184–185 blurred vision, 62 bolus advice, 21, 154–162 bolus advice options. See advice options bolus, delivery, 22, 240 buttons, 13, 15–17 C carbohydrates, 52–55, 91, 95 units of measure, 181–183, 278 carb ratio, 158, 241 carbs. See carbohydrates CC, 181–183, 278 cleaning meter, 233 code chip.
E electromagnetic compatibility, 261 errors, list of, 224–226 F fatigue, 62 frequent urination, 62 G g (grams), 181–183, 278 graph, standard day, 112–115 standard week, 121–124 target, 129–131 trend, 102–106 H headache, 62 health events, 26, 52–55, 91, 95, 160, 168–169 high bG retest reminder, 210, 214 hyper warning limit, 23, 172–174, 238, 249 hypo warning limit, 23, 172–174, 238, 250 I icons, listing, 87–88, 205–206 infrared (IR) window, 13–14, 136 infusion set change reminder, 149–153, 210, 212 insulin
L lab test reminder, 149–153, 211–212 lancing device, 47–48 language, 178–180 lock. See key lock low bG retest reminder, 211–213 P pairing, 17, 186 patent information, 268–271 power button, 13, 15–17 power-saving tips, 232 pump.
snooze, 141, 146, 207, 217 soft keys, 13, 15–17 sound.
V vibrate, setting, 187–189 W warnings, list of, 218–223 warranty, 265–267 300
