ACCU-CHECK Avia Combo Owner'S Booklet Download

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Aviva Combo

Accu-chek Aviva combo

05071739002-0809

Blood SUGAR MeteR

Standard Owner’s Booklet

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. and any

use of such marks by Roche is under license. Other

trademarks and product names are the property of

their respective owners.

Summary of Contents for Avia Combo

Page 1: ...t 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 and any use of such marks by Roche is under license Other trademarks and product names are the property of their respec...

Page 2: ...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 The ACCU CHEK Multiclix device and its use are covered by the following U S patents 4 924 879 Re 35 803 6 419 661 Additional U S patents pending ...

Page 3: ... problems Set the time and date on your meter before you begin testing Inspect the test strip container before using the test strips for the first time If you see any damage to the container cap or if anything prevents the cap from closing properly do not use the test strips Contact ACCU CHEK Pump Support at 1 800 688 4578 Damaged test strips can cause inaccurate results which could lead to improp...

Page 4: ...accurate 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 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 ACC...

Page 5: ...ted 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 sugar hypoglycemia Others such as children or people who are unconscious or have certain disabilities may not be able to communicate their symptoms to caregivers For these reasons do not chan...

Page 6: ...THAT DOES NOT MATCH HOW YOU FEEL OR IF YOU BELIEVE THAT YOUR TEST RESULT COULD BE INCORRECT If your blood sugar 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 sugar if...

Page 7: ... 2 The ACCU CHEK Aviva Combo Meter at a Glance 13 1 3 The ACCU CHEK Spirit Combo Insulin Pump at a Glance 18 1 4 Summary of Features 19 1 5 Screen Content and Navigation 29 2 Testing Your Blood Sugar 37 2 1 Overview 38 2 2 Coding Your Meter 39 2 3 Using the ACCU CHEK Aviva Combo System 41 2 4 Performing a Blood Sugar Test 43 ...

Page 8: ...62 3 Control Testing 65 3 1 Overview 66 3 2 Why Perform Control Tests 67 3 3 About the Control Solutions 68 3 4 Performing a Control Test 69 3 5 Understanding Control Test Results 75 4 Managing Your Data 81 4 1 Overview 82 4 2 Viewing or Modifying Your Data 85 4 3 Adding New Data 94 4 4 Reporting Your Data 97 4 5 Downloading Your Data to a Computer 135 ...

Page 9: ... 154 5 6 Setting Time Blocks Health Events Advice Options Bolus Advice Set Up 163 5 7 Setting Warning Limits Hyper Hypo 172 5 8 Turning Key Lock On or Off 175 5 9 Setting the Language 178 5 10 Setting Units Carbs 181 5 11 Turning Bluetooth Wireless Technology On or Off 184 5 12 Pairing the Meter and Pump 186 5 13 Setting the Beeper Vibrate and Key Sound 187 5 14 Setting the Time Format Time and Da...

Page 10: ...7 6 4 List of Reminders 208 6 5 List of Warnings 218 6 6 List of Errors 224 7 Care and Maintenance 227 7 1 Overview 228 7 2 Changing the Batteries 229 7 3 Power Saving Tips 232 7 4 Cleaning the Meter 233 7 5 Maintenance and Testing 234 8 Troubleshooting 235 8 1 Overview 236 8 2 Troubleshooting the ACCU CHEK Aviva Combo Meter 237 ...

Page 11: ...0 9 5 Disposing of the Meter Strips Lancets and Batteries 263 9 6 Warranty 265 9 7 Additional Supplies 272 9 8 Information for Healthcare Professionals 273 Appendices 275 Appendix A Abbreviations 275 Appendix B Carb Units 278 Appendix C Explanation of Symbols 279 Appendix D Meter Settings and Range Limits 280 Glossary 285 Index 295 ...

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Page 13: ...meter Testing your blood sugar Control testing Managing your data Changing the meter settings Understanding the icons reminders warnings and errors Care and maintenance Troubleshooting Technical information 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 O...

Page 14: ...inistering a bolus 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 sugar test results For detailed information about the features of the meter see Chapter 1 U...

Page 15: ...r by professionals in a clinical setting as an aid to effective diabetes management Testing sites include traditional fingertip site along with palm forearm upper arm thigh and calf The ACCU CHEK Aviva Combo meter can also be used to interface with and remotely control compatible ACCU CHEK insulin infusion pumps via Bluetooth wireless technology radio frequency communication The ACCU CHEK Aviva Co...

Page 16: ...ry day Discussing your results with your healthcare professionals and following their advice about medicine exercise 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 or forearm The meter is for outside the body in vitro use It should not be used to di...

Page 17: ...standing Your New System 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 18 1 4 Summary of Features 19 1 5 Screen Content and Navigation 29 ...

Page 18: ...hows 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 Code key and code chip are interchangeable and mean the same thing Blood sugar and bG are interchangeable and mean the same thing ...

Page 19: ...Keys Press 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 Insert code key here with code number facing away from you Battery Door Remove the battery door by pushing the tab and pulling the door up Backlight Button Press to adjus...

Page 20: ...sert batteries according to the and symbols in the battery compartment Test Strip 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 Control Solution Bottle for example ...

Page 21: ...ve 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 Left Soft Key Up Arrow Enter Left Arrow Power On Off Right Soft Key Right Arrow Down Arrow Backlight ...

Page 22: ... 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 Backlight j Adjust the backlight level low medium high j From the Bluetooth screen press and hold to turn Bluetooth wireless technology on and off Power On Off j Turn t...

Page 23: ... 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 and then press Meter Pump Pairing j Begins meter and pump pairing ...

Page 24: ...CK INFO screen Display 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 Se...

Page 25: ...just the backlight 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 informati...

Page 26: ...sounds and vibrations For more information see Chapter 6 Icons Reminders Warnings and Errors Blood Sugar Test Your new meter allows you to enter detailed information for each blood sugar test to include Meal time pre meal post meal bedtime or other Carbs the amount of carbohydrates you are intending to eat Health events fasting exercise 1 stress illness exercise 2 or premenstrual If bolus advice i...

Page 27: ...meter For instructions on how to set up bolus advice see Chapter 5 Changing Meter Settings w 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...

Page 28: ...ing 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 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 Da...

Page 29: ...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 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 C...

Page 30: ...s 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 You may set up to eight time blocks For more information see Chapter 5 Changing Meter Settings ...

Page 31: ... 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 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 ...

Page 32: ...r 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 For instructions on how to set up bolus advice see Chapter 5 Changing Meter Settings ...

Page 33: ...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 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 sugar test reminders can be turned on or off indi...

Page 34: ...ion 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 For more information see Chapter 5 Changing Meter Settings ...

Page 35: ... 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 ...

Page 36: ... when the meter batteries are low Bluetooth Wireless Technology Icon Indicates whether the Bluetooth wireless technology is on off or connecting Features on the Main Menu i NOTES To select an item on a menu press x or z to highlight blue the menu item and then press When remotely controlling your pump the buttons of your meter have differing functions For more information see the Advanced Owner s ...

Page 37: ...ogy 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 ...

Page 38: ...32 Connecting to the Pump This screen appears when Bluetooth wireless technology is on and the meter is connecting to the pump Connecting to the Pump screen during pairing ...

Page 39: ...nu text is displayed here Left Soft Key Option Press to select the option 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 sc...

Page 40: ...ntered 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 Pop Up Entry Field Pop Up Menu ...

Page 41: ...enu option and press j Repeat the previous step as necessary Bolus Advice Pump My Data Settings bG Test 10 02 am 2 Feb 08 Bolus Advice Meter Sound Vibrate Menu Reminders 10 02 am 2 Feb 08 Time Date Time Blocks End Back 5 30 am Time Blocks Start 11 00 am 5 00 pm 9 30 pm 12 00 am 12 00 am 5 30 am 11 00 am 5 00 pm 9 30 pm ...

Page 42: ... 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 Target Range Cancel 5 30 am Time Blocks 12 00 am 140 mg dL Save 70 mg dL Target Range Cancel 5 30 am Time Blocks 12 00 am 140 mg dL 70 mg dL 5 30 am ...

Page 43: ...7 227 7Care and Maintenance 7 1 Overview 228 7 2 Changing the Batteries 229 7 3 Power Saving Tips 232 7 4 Cleaning the Meter 233 7 5 Maintenance and Testing 234 ...

Page 44: ...verview 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 ...

Page 45: ...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 3 j Put the battery door back in place and snap it closed ...

Page 46: ... 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 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 ...

Page 47: ...e pump when you remove and 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 I f the backlight level is set to high...

Page 48: ...ower Saving Tips To conserve battery life Use the low beeper setting Only turn on the vibration feature when it is needed Turn off the meter when you are finished rather than utilizing the auto power off feature ...

Page 49: ...ng solutions 70 isopropyl alcohol Mild dishwashing liquid mixed with water 10 household bleach solution 1 part bleach plus 9 parts water made the same day Squeeze out any excess liquid from the cloth before you wipe the meter surface DO NOT Get any moisture in the code key slot or test strip slot Spray any cleaning solution directly onto the meter Put the meter under water or liquid Pour liquid in...

Page 50: ... 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 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 Pump Su...

Page 51: ...235 8 8Troubleshooting 8 1 Overview 236 8 2 Troubleshooting the ACCU CHEK Aviva Combo Meter 237 ...

Page 52: ...tact 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 i NOTES 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 AC...

Page 53: ...CHEK Pump Support 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 Ensur...

Page 54: ... 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 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 sugar as recommended by your healthcare professional j The meter disp...

Page 55: ...y not reflect the pump 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 fo...

Page 56: ...eter cannot communicate 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 ...

Page 57: ...ed j Turn off the meter and recode it See Chapter 2 Testing Your Blood Sugar 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 the pu...

Page 58: ... accurate j Communication 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 ...

Page 59: ...on the meter the meter 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 o...

Page 60: ...t strip and reinsert it or replace it if damaged Verify that the code number printed on the test strip container matches the code number printed on the code key currently inserted in the meter If the message reappears contact ACCU CHEK Pump Support at 1 800 688 4578 E 52 Code Key Error j The code key is incorrect j Turn off the meter remove the code key and reinsert the code key into the meter If ...

Page 61: ...esting Your Blood Sugar If this still does not confirm 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 sugar test with a new test strip If the E 53 error still appears for your blood sugar test your blood sugar result may be extremely high and above the...

Page 62: ... test strips j Ensure the code key number matches the code number on the test strip container Remove and reinsert the code key and ensure the time and date in the meter are correct If this does not fix the problem turn off the meter remove the expired code key and insert a new valid code key into the meter E 56 Sample Applied Early j Blood or control solution was applied to the test strip before t...

Page 63: ... Temp Error 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 five 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 7 ...

Page 64: ...or additional solutions 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...

Page 65: ... to or greater than the offset time Reset the acting time value or revise the offset time Invalid Date j The date entered is invalid dates for reminders cannot be set to occur in the past j Re enter 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 b...

Page 66: ...he 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 j Select OK and re enter the PIN shown on the pump display Invalid Record Time Date j The time date entered is invalid Add Data entries cannot be set to occur in the future ...

Page 67: ...flicts 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 sugar may be lower than the measuring range of the system j If you are experiencing any of the common symptoms of low blood sugar contact...

Page 68: ...instructions on how to pair the meter and pump see the Advanced Owner s Booklet Meter Battery Low j Battery power is low j Install new batteries See Chapter 7 Care and Maintenance No 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 Res...

Page 69: ...he 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 j Before the end of the month insert a new code key from a new box of test strips dispose of expiring test strips and ensure the code key number matches the code number on the test strip container j Ensure the time and date ...

Page 70: ... time and date were changed to match the pump time Ensure the time and date are correct If the time or date are not correct change the time and date on the pump i NOTES For additional information on errors 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 Pump Support at 1 800 688 4578 ...

Page 71: ...256 9 2 Product Limitations 257 9 3 Specifications 258 9 4 Product Safety Information 260 9 5 Disposing of the Meter Strips Lancets and Batteries 263 9 6 Warranty 265 9 7 Additional Supplies 272 9 8 Information for Healthcare Professionals 273 ...

Page 72: ...256 9 1 Overview This chapter provides you with important performance information regarding the meter ...

Page 73: ...9 257 9 2 Product Limitations Please read the literature packaged with your test strips to find the latest information on product specifications and limitations ...

Page 74: ...efer 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 Relative humidity operating range j Refer to the test strip package insert Memory capacity j 1 000 diary records Automatic power off j 2 minutes ...

Page 75: ...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 Control solution storage conditions j 36 F to 90 F Interface j IR LED IRED Class 1 ...

Page 76: ...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 device may not cause har...

Page 77: ...radiate radio frequency energy 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 operating in conjunction with any other antenna or transmitter Electromagnetic Compatibility This meter meets the electrom...

Page 78: ...using the hexokinase method For method comparison the results were compared with results obtained using the hexokinase 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 w warningS Strong electromagnetic fields may interfere with the proper operation of the meter Do ...

Page 79: ...02 96 EC This is not a requirement for the U S A however Roche is committed to recycling and sustainability Please consider the following 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...

Page 80: ... 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 1030 Bloodborne pathogens Directive 2002 96 EC Directive on waste electrical and electronic equipment WEEE ...

Page 81: ...rials or workmanship Disetronic Medical Systems 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 ...

Page 82: ...PECIAL OR PUNITIVE DAMAGES ARISING FROM OR 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 THREE YEARS FROM THE DATE OF PURCHASE Some states do not allow limitations on how long an implied warranty will last or the exc...

Page 83: ...our 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 Further inquiries should be directed to ACCU CHEK Pump Support at 1 800 688 4578 Be sure to fill out and mail the Warranty Card that comes with the ...

Page 84: ...e the ACCU CHEK Aviva Combo system is only granted when the ACCU CHEK Aviva Combo meter is used with the ACCU CHEK Aviva test strips and ACCU CHEK Aviva code keys ACCU CHEK Aviva test strips are provided with a specifically matched ACCU CHEK Aviva code key These test strips and code keys are specifically manufactured for operation with the ACCU CHEK Aviva Combo meter Use of other test strips with ...

Page 85: ...please call ACCU CHEK Pump Support 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 test strips or code keys Patent Information Aspects of the ACCU CHEK Aviva Combo system including the meter code key and test strips and the...

Page 86: ...ense to use the ACCU CHEK Multiclix device is only granted when ACCU CHEK Multiclix lancet drums are used with the ACCU CHEK Multiclix device ACCU CHEK Multiclix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the ACCU CHEK Multiclix device Use of other lancets or lancet drums with the ACCU CHEK Multiclix device may prev...

Page 87: ... 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 Multiclix device for a full refund If you have any questions please call ACCU CHEK Pump Support at 1 800 688 4578 Except where prohibited by statute all warranties covering the ACCU CHEK Multiclix device are voided by use of the ACCU CHEK Multiclix device with any...

Page 88: ...wing supplies and accessories are available from your authorized Roche Diabetes Healthcare Center pharmacies or your medical surgical supply dealer Test Strips ACCU CHEK Aviva test strips Control Solutions ACCU CHEK Aviva control solutions ...

Page 89: ...ing 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 ...

Page 90: ...ation and blood perfusion throughout the body can lead to sample site to site differences in blood sugar results These physiological effects vary between individuals and can vary within a single individual based upon his or her behavior and relative physical condition Our studies involving AST of adults with diabetes show that most persons will find their sugar level changes more quickly in the fi...

Page 91: ... 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 ...

Page 92: ...on 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 RF j Radio Frequency ...

Page 93: ...277 Abbreviation Definition SD j Standard Deviation U j Units bolus insulin units ...

Page 94: ...ing 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 ...

Page 95: ... 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 i j Note additional information j Store at j 1 5V AAA ...

Page 96: ... 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 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 ...

Page 97: ...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 1 1 Meal Rise bG mg dL 50 200 1 50 Multiwave Bolus insulin Units 0 2 501 0 1 No entry u ...

Page 98: ...s 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 1 No entry u 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 ...

Page 99: ...bG test reminders To turn 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 ...

Page 100: ...our healthcare professional 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 ...

Page 101: ...lin j Bolus insulin that has been given to lower your blood sugar but has not yet been fully used Advice Options j Factors that influence bolus advice calculations including meal rise snack size acting time and offset time After High bG Reminder j A reminder to retest your blood sugar When enabled this reminder occurs after a high blood sugar test result After Low bG Reminder j A reminder to retes...

Page 102: ...nders to retest your blood sugar after a high blood sugar test result after a low blood sugar test result or after a meal bG Threshold j A bG test reminder setting The upper limit for your blood sugar for a high bG test reminder and the lower limit for your blood sugar for a low bG test reminder Blood Sugar bG j The level of sugar in blood Bluetooth Wireless Technology j Wireless short range commu...

Page 103: ...y of the bolus amount During this delay you are able to cancel the bolus delivery by pressing x or z The meter beeps and returns to the Pump Run screen Carb Ratio j The amount of insulin necessary to account for a certain number of carbohydrates Carbohydrates or Carbs j Carbohydrate foods include sugars and starches Carbohydrates can raise blood sugar levels slowly or rapidly Carbohydrates are gen...

Page 104: ...y 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 Current Date j Refers to the date you set through the menu Settings and then in the Time Date screen Current Time j Refers to the time you set through the menu Settings and then in the Time Date screen Day j Period of time st...

Page 105: ...d the meter and pump are communicating Health Events j A pop up menu selection fasting exercise 1 stress illness exercise 2 or premenstrual that allows information to be stored with a blood sugar test result or in a diary record and percentages that could adjust bolus advice recommendations for your current health status or activities HI j The test result is above the meter s measurement range Hyp...

Page 106: ...y 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 Ketones are produced when there is not enough insulin to help your body use sugar for energy Without enough insulin sugar builds up in the blood Key Lock j A meter function which disables th...

Page 107: ...edtime or other that allows information to be stored with a blood sugar test or in a diary record Meter j Blood sugar meter Multiwave Bolus j A bolus designed to better simulate the body s insulin delivery It combines an immediate bolus delivery followed by an Extended Bolus delivery A Multiwave Bolus can be helpful when you have meals that include both rapidly and slowly absorbed carbohydrates Th...

Page 108: ...her 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 0 2 0 See the pump User Guide for more information Remind After j A bG test reminder setting The amount of time after a high blood sugar test result after a low blood sugar test result or after a meal you want the reminder to occur Remind...

Page 109: ...ancel Back etc Standard Bolus j A bolus that is immediately delivered to cover a food or a blood sugar 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 j As it is used in this owner s booklet standard deviation measures how widely spread t...

Page 110: ...ods 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 Warning Limits j See Hyper Warning Limit or Hypo Warning Limit ...

Page 111: ...m 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 type 229 231 BE 181 183 278 beeper setting 30 187 189 bG test reminder 27 209 212 283 bG threshold 143 144 blood sugar averages 99 100 blood sugar test features 20 performing 43...

Page 112: ... 278 cleaning meter 233 code chip See code key code key 14 39 40 241 244 246 code number 46 coding the meter 39 40 communication 237 241 243 248 control solution 14 68 71 control test performing 67 69 74 results 72 73 75 78 results troubleshooting 79 80 D data 22 adding 53 55 94 96 downloading to a computer 23 135 137 modifying 85 93 reporting 97 134 trends 101 110 viewing 85 93 date reminders 28 ...

Page 113: ...che 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 pump 18 insulin pump connecting See pairing insulin sensitivity 158 249 K KE 181 183 278 key lock 17 20 175 177 key sound setting 1...

Page 114: ...0 284 summary of features 13 19 28 N navigation 35 36 numbness 62 O offset time 161 162 171 P pairing 17 186 patent information 268 271 power button 13 15 17 power saving tips 232 pump See insulin pump R rapid heartbeat 62 reminders important information 212 217 list of 208 211 other 211 priority 212 S safety information product 260 262 screen features 30 33 34 scroll bar 33 signal settings 20 sna...

Page 115: ... day 116 119 standard week 125 127 target 132 134 trend 107 110 target range 155 158 166 193 195 251 target reporting 128 135 test results storing 83 84 unusual 60 61 test strip 14 244 253 thirst increased 62 time blocks 24 25 154 167 193 200 284 time change data 102 104 107 108 time format setting 190 191 time setting 190 192 tingling 62 trembling 62 troubleshooting 237 254 U units of measure See...

Page 116: ...300 V vibrate setting 187 189 W warnings list of 218 223 warranty 265 267 ...

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ACCU-CHECK Avia Combo, Owner'S Booklet

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