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ACCU-CHECK Avia Combo Owner's Booklet

Blood sugar meter
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Accu-chek Aviva combo
©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. and any
use of such marks by Roche is under license. Other
trademarks and product names are the property of
their respective owners.
Aviva Combo
Blood SUGAR MeteR
Standard Owner's Booklet

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  • Page 1 Accu-chek Aviva combo Aviva Combo Blood SUGAR MeteR Standard Owner’s Booklet ©2009 Roche Diagnostics. All rights reserved. Accu-chek, Accu-chek AVIVA, Accu-chek AVIVA cOMBO, Accu-chek SPIRIT cOMBO, and Assembled in uSA. Accu-chek MuLTIcLIX are trademarks of Roche. Distributed by: Disetronic Medical Systems Inc. The Bluetooth ®...
  • Page 2 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;...

  • Page 3: Before You Start Testing

    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.
  • Page 4 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. •...
  • Page 5 About Testing Yourself or Others 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.
  • Page 6 • 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.

  • Page 7: Table Of Contents

    Contents Before You Start Testing Introduction 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...
  • Page 8 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 3 Control Testing 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...
  • Page 9 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...
  • Page 10 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...
  • Page 11 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 9.8 Information for healthcare Professionals Appendices Appendix A: Abbreviations Appendix B: carb units Appendix c: explanation of Symbols Appendix D: Meter Settings and Range Limits Glossary...

  • Page 13: Introduction

    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.

  • Page 14: The Accu-Chek Aviva Combo System

    The ACCU‑CHEK Aviva Combo System The Accu-chek Aviva Combo meter is for quantitative blood sugar testing using ACCU‑CHEK Aviva test strips. The meter has many features including: • Controlling your ACCU‑CHEK Spirit combo pump • Administering a bolus • Bolus advice •...
  • Page 15 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.
  • Page 16 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 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;...

  • Page 17: Understanding Your New System

    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 1.5 Screen content and Navigation...

  • Page 18: Overview

    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. NOTES: • This booklet shows sample screens. The screens in this booklet may look slightly different from the screens on the meter.

  • Page 19: The Accu-Chek Aviva Combo Meter At A Glance

    1.2 The ACCU‑CHEK Aviva Combo Meter at a Glance Display Infrared (IR) Window Shows menus, results, Transfers data from the messages, and data stored in meter to a computer. the diary. Code Key Slot Buttons Insert code key here with code number facing away Press to enter menus or the diary, adjust settings, and...
  • Page 20 Top View Code Key Batteries Infrared (IR) Window (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 (for example) (for example) or control solution here.
  • Page 21 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 NOTES: • You hear a sound every time an active button/soft key is pressed unless you turned off the key sound. •...
  • Page 22 Table of Buttons and Soft Keys Button Name Function < Left Arrow Move or scroll to the left in a screen. > Right Arrow Move or scroll to the right in a screen. up Arrow Move or scroll up in a screen. Down Arrow Move or scroll down in a screen.
  • Page 23 Table of Button Combinations Button Combination Name Function When the buttons are locked, press and unlock keys unlocks the buttons. hold until the Main Menu appears. With the meter turned off, press and hold Meter/Pump Begins meter and pump pairing. and then press +.

  • Page 24: The Accu-Chek Spirit Combo Insulin Pump At A Glance

    1.3 The ACCU‑CHEK Spirit Combo Insulin Pump at a Glance Up Key Menu Key Moves forward in an information cycles through menus, screen, increases a setting, turns functions, and information on the backlight, programs a Quick screens. Bolus, cancels a Quick Bolus, and OK Key turns off the STOP-Warning.

  • Page 25: Summary Of Features

    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. •...
  • Page 26 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 •...
  • Page 27 Bolus Advice (Optional) • 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. •...
  • Page 28 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 •...
  • Page 29 Data Transfer • You can transfer your data stored on the meter to a computer. • For more information, see Chapter 4, “Managing Your Data.” 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.
  • Page 30 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. •...
  • Page 31 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. With bolus advice, you need to consider the following when setting up time blocks: •...
  • Page 32 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.
  • Page 33 Blood Sugar Test Reminders (Optional) 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: •...
  • Page 34 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 •...

  • Page 35: Screen Content And Navigation

    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.
  • Page 36 Features on the Main Menu: Sound Icon Vibrate Icon Appears when the beeper is Appears when vibrate is turned on. 10:02 am 2 Feb 08 turned on. bG Test Date Bolus Advice Time Pump Low Battery Icon My Data Menu Options Appears when the meter batteries are low.
  • Page 37 Bluetooth Wireless Technology Icon Communication States 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.
  • Page 38 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.
  • Page 39 Features on a screen: Title Bar Highlighted Option View Data 2 Feb 08 Primary menu title is displayed When a menu choice or item 8:06 pm here. is selected, it is highlighted in 5:33 pm blue. Secondary Title Bar 4:06 pm Scroll Bar When necessary, a secondary 1:52 pm...
  • Page 40 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 to select the appropriate pop-up menu option or until the correct numerical entry is present, and then press =.
  • Page 41 General Navigation Steps To change the settings or enter information into the meter: 10:02 am 2 Feb 08 10:02 am 2 Feb 08 Time Blocks Start bG Test Reminders 12:00 am 5:30 am Bolus Advice Bolus Advice 5:30 am 11:00 am Pump Meter 11:00 am...
  • Page 42 Select Save by pressing Time Blocks Time Blocks 5:30 am 12:00 am 5:30 am 12:00 am 5:30 am save changes and return to the previous screen. Target Range Target Range 70 mg/dL 140 mg/dL 70 mg/dL 140 mg/dL Cancel Save Cancel Press Press...

  • Page 43: Overview

    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...

  • Page 44: Overview

    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.

  • Page 45: Changing The Batteries

    7.2 Changing the Batteries Remove the battery door Remove the old batteries from Put the battery door back in from the back of the meter by the meter. place and snap it closed. pushing the tab in the direction Insert three AAA batteries with of the arrow and pulling the the + and - ends matching door up.
  • Page 46 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.
  • Page 47 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. •...

  • Page 48: Power-Saving Tips

    7.3 Power‑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: Cleaning The Meter

    7.4 Cleaning the Meter caring for the meter is easy: just keep it free of dust. If you need to clean it, follow these guidelines carefully to help you get the best performance possible: • Ensure the meter is off •...

  • Page 50: Maintenance And Testing

    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.”...

  • Page 51: Troubleshooting

    Troubleshooting 8.1 Overview 8.2 Troubleshooting the Accu-chek Aviva combo Meter...

  • Page 52: Overview

    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.

  • Page 53: Troubleshooting The Accu-Chek Aviva Combo Meter

    8.2 Troubleshooting the ACCU‑CHEK Aviva Combo Meter Display Shows Possible Cause(s) Possible Solution(s) The display is Batteries are dead. Install new batteries. See chapter 7, “care and blank or the meter Maintenance.” will not turn on. Display is damaged. contact Accu-chek Pump Support at 1-800-688-4578.
  • Page 54 Display Shows Possible Cause(s) Possible Solution(s) Above hyper Your test result is above the Treat your high blood sugar as recommended by Warning Limit hyper warning limit set in the your healthcare professional. meter. consider checking bG, ketones, and insulin. See the pump user Guide for additional solutions.
  • Page 55 Display Shows Possible Cause(s) Possible Solution(s) Bolus Advice Bolus advice data integrity Wait 8 hours for accurate bolus advice. cannot be confirmed. Bolus Advice data deleted IMPORTANT: • Insulin doses and meals taken before the Bolus Advice warning are no longer reflected in the bolus advice calculation.
  • Page 56 Display Shows Possible Cause(s) Possible Solution(s) Bolus Delivery The meter cannot Retry or set to Manual Pump. unavailable communicate with the pump. ensure the meter and pump have Bluetooth wireless technology turned on. ensure the meter and pump are within communication range.
  • Page 57 Display Shows Possible Cause(s) Possible Solution(s) carbohydrate Ratio carbohydrate ratio is outside check your entries and contact your healthcare of the acceptable meter professional to determine the appropriate settings. range. code key Missing The meter is not coded or the Turn off the meter and recode it.
  • Page 58 Display Shows Possible Cause(s) Possible Solution(s) communication communication of bolus data ensure the meter and pump have Bluetooth wireless Warning from the pump was not technology turned on. successful. Therefore, pump ensure the meter and pump are within data are not available and the communication range.
  • Page 59 Display Shows Possible Cause(s) Possible Solution(s) connection Lost The connection was lost Restart the pairing process. See the Advanced between the meter and the Owner’s Booklet. pump during the pairing ensure the meter and pump have Bluetooth wireless process. Therefore, the technology turned on.
  • Page 60 Display Shows Possible Cause(s) Possible Solution(s) e-51 Bad Strip Your blood sugar may be If you see this error message after you applied error extremely low. blood to the test strip, see chapter 2, “Testing Your Blood Sugar.” The test strip is damaged. If you see this error message before you applied The test strip is not properly blood to the test strip, remove the test strip and...

  • Page 61: Control Testing

    Display Shows Possible Cause(s) Possible Solution(s) e-53 Bad Test A meter or test strip error has Discard the test strip and repeat the test. error occurred. Your blood sugar may be If this confirms how you feel, contact your extremely high. healthcare professional immediately.
  • Page 62 Display Shows Possible Cause(s) Possible Solution(s) e-54 Not enough Not enough blood or control Discard the test strip and repeat the test. Sample solution was drawn into the test strip for measurement or was applied after the test has started. e-55 code key The code key is from an ensure the code key number matches the code...
  • Page 63 Display Shows Possible Cause(s) Possible Solution(s) e-57 electronic An electronic error has Turn off the meter and remove the batteries. Wait at error occurred or, in rare cases, a least 30 seconds prior to reinserting the batteries. used test strip was removed Turn on the meter and perform a blood sugar or and reinserted.
  • Page 64 Display Shows Possible Cause(s) Possible Solution(s) hI bG Warning Your blood sugar may be If you are experiencing any of the common higher than the measuring symptoms of high blood sugar, contact your range of the system. healthcare professional immediately. Treat your high blood sugar as recommended by your healthcare professional.
  • Page 65 Display Shows Possible Cause(s) Possible Solution(s) Insulin Sensitivity Insulin sensitivity is outside of check your entries and contact your healthcare the acceptable meter range. professional to determine the appropriate settings. Invalid Bolus The acting time value is less The acting time value must be set equal to or Advice Times than the offset time.
  • Page 66 Display Shows Possible Cause(s) Possible Solution(s) Invalid hypo Values The hypo warning limit value Reset the hypo warning limit or revise the target must be less than all of your ranges in time blocks and re-enter the hypo target ranges in the time warning limit.
  • Page 67 Display Shows Possible Cause(s) Possible Solution(s) Invalid Target The lower target range value Reset the target range values. Range is above the upper target enter the correct lower target range value and range value. upper target range value. See chapter 5, “changing Meter Settings.”...
  • Page 68 Display Shows Possible Cause(s) Possible Solution(s) Meter and Pump Meter and pump have not You must pair the meter and pump to use these Not Paired been paired. You cannot use features. the pump functions without For instructions on how to pair the meter and pump, pairing the meter and the see the Advanced Owner’s Booklet.
  • Page 69 Display Shows Possible Cause(s) Possible Solution(s) Pump Not Available The pump is out of the ensure the meter and pump have Bluetooth wireless communication range of the technology turned on. meter. ensure the meter and pump are within communication range. If the low battery icon is displayed, the meter cannot communicate with the pump.
  • Page 70 Display Shows Possible Cause(s) Possible Solution(s) Time Mismatch The time or date on the meter 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.
  • Page 71 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 9.8 Information for healthcare Professionals...

  • Page 72: Overview

    9.1 Overview This chapter provides you with important performance information regarding the meter.

  • Page 73: Product Limitations

    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: Specifications

    9.3 Specifications Blood volume Refer to the test strip package insert. Sample type Fresh whole blood Measuring time Refer to the test strip package insert. Measuring range Refer to the test strip package insert. Test strip storage conditions Refer to the test strip package insert. Meter storage conditions (with -4 °F to 122 °F batteries inserted)
  • Page 75 Power supply Three AAA batteries (recommended: alkaline) Display Dimensions 3.7 x 2.1 x 1 inches (LWH) Weight Approximately 3.6 oz with batteries inserted construction hand-held Protection class Meter type The Accu-chek Aviva combo meter is suitable for continuous operation. control solution storage conditions 36 °F to 90 °F Interface IR;...

  • Page 76: Product Safety Information

    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.
  • Page 77 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. Changes or modifications to the device not expressly approved by Roche could void the user’s authority to operate the device.
  • Page 78 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.

  • Page 79: Disposing Of The Meter, Strips, Lancets, And Batteries

    9.5 Disposing of the Meter, Strips, Lancets, and Batteries 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.
  • Page 80 • 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.

  • Page 81: Warranty

    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.
  • Page 82 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.
  • Page 83 Warranty Instructions 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.
  • Page 84 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. 6,645,368; 5,366,609; 5,352,351; 5,053,199; 5,122,244; 7,276,146; 7,276,147; and Re.
  • Page 85 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.
  • Page 86 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.
  • Page 87 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.

  • Page 88: Additional Supplies

    9.7 Additional Supplies The following 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: Information For Healthcare Professionals

    9.8 Information for Healthcare Professionals 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.
  • Page 90 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.
  • Page 91 Appendices Appendix A: Abbreviations Abbreviation Definition Ante Meridiem (12‑hour clock notation for “before noon”) Alternative Site Testing Bread Equivalent (equal to 12 grams of carbohydrates) Blood Sugar carbs carbohydrates Carbohydrate Choice (equal to 15 grams of carbohydrates) °F Degrees Fahrenheit Federal Communications Commission (United States) Grams Gigahertz...
  • Page 92 Abbreviation Definition hyper Hyperglycemia (high blood sugar) hypo Hypoglycemia (low blood sugar) Infrared International Organization for Standardization Kohlenhydrateinheit (equal to 10 grams of carbohydrates) Liquid Crystal Display mg/dL Milligrams per Deciliter Not Applicable NIST National Institute of Standards and Technology (United States) Personal Identification Number Post Meridiem (12‑hour clock notation for “after noon”) Radio Frequency...
  • Page 93 Abbreviation Definition Standard Deviation Units (bolus insulin units)
  • Page 94 Appendix B: Carb Units For carbohydrates, the following units of measure are available on the meter. Abbreviation Unit of Measurement Gram Equivalent Grams* 1 gram kohlenhydrateinheit 10 grams Bread Equivalent 12 grams carbohydrate choice 15 grams *Standard unit of measure in the U.S.
  • Page 95 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. Warning (refer to accompanying documents). Please refer to safety‑related notes in the owner’s booklets accompanying this instrument.
  • Page 96 Appendix D: Meter Settings and Range Limits mg/dL 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 99.9 No entry (“‑‑‑ u”) bG Threshold (High) mg/dL hyper Warning Limit bG Threshold (Low) mg/dL hypo Warning Limit Carb Ratio (carbs)
  • Page 97 Data Type Unit of Measurement MIN MAX Increments Default Setting Exercise 1 (health event) Exercise 2 (health event) extended Bolus units No entry (“‑‑‑ u”) (insulin) hyper Warning Limit mg/dL hypo Warning Limit mg/dL Illness (health event) Insulin Sensitivity mg/dL No entry (“‑‑‑mg/dL”) (bG) Insulin Sensitivity...
  • Page 98 Data Type Unit of Measurement MIN MAX Increments Default Setting Offset Time hours:minutes 0:45 Acting 0:15 1:00 Time Premenstrual (health event) Snack Size (carbs) grams No entry (“‑‑‑ g”) No entry (“‑‑‑ BE”) No entry (“‑‑‑ KE”) No entry (“‑‑‑ CC”) Standard Bolus units No entry (“‑‑‑...

  • Page 99: Changing Meter Settings

    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.” Test Reminder Default Time of Day 7:00 am 9:00 am 11:00 am 12:00 pm 2:00 pm...
  • Page 100 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.” Time Block 12‑Hour Format 12:00 am–5:30 am 5:30 am–11:00 am 11:00 am–5:00 pm...
  • Page 101 Glossary Term Definition 7-day average Includes results generated today and the previous 6 days. Acting Time 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.
  • Page 102 Term Definition After Meal Reminder 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 Audible or vibrating (silent) notification indicating a reminder, warning, or error.
  • Page 103 Term Definition Bolus Advice 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 See Advice Options. Bolus Delivery Start Delay The Standard Bolus icon blinks for five seconds and then the meter communicates to the pump to begin delivery of the bolus amount.
  • Page 104 Term Definition control Result 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 A meter test using control solution which lets you know that the meter and test strips are working properly.
  • Page 105 Term Definition end Time The end time of a time block. extended Bolus 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).
  • Page 106 Term Definition hypo hypoglycemia: an abnormally low level of sugar in the blood. hypo Warning Limit When your blood sugar test result is below the hypo warning limit, a warning is displayed. Insulin Pump A device that delivers a continuous supply of insulin into the body. Insulin Sensitivity The amount of insulin necessary to lower your blood sugar by a certain amount.
  • Page 107 Term Definition The test result is below the meter’s measurement range. Meal Rise 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 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...
  • Page 108 Term Definition Offset Time 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 A pump and meter exclusively communicating and transferring information with each other.
  • Page 109 Term Definition Snack Size The amount of carbohydrates that is not to be counted as a regular meal with the expected meal rise. Snooze Delay of some reminders for a defined time period. Soft keys Two buttons under the meter display used to navigate through the user interface.
  • Page 110 Term Definition Target Range The range of your blood sugar results considered acceptable when you are fasting. Time Blocks up to eight time periods within one day to facilitate your changing insulin needs throughout the day. Time Range The user sets the duration of time. There is a start and end time. user A person using the meter or pump.
  • Page 111 Index abbreviations, 275–277 backlight, 19, 201–202 acting time, 160–162, button, 13, 16–17 active insulin, 52–55 batteries, advice options, 170–171 changing, 229–231 after high bG test reminder, 141–145, 208, 210, low, type, 229, after low bG test reminder, 141–145, 208, Be, 181–183, 211–212 beeper, setting, 30, 187–189...
  • Page 112 Bluetooth wireless technology, 260–261 control test, turning on or off, 16, 31, 184–185 performing, 67, 69–74 blurred vision, results, 72–73, 75–78 bolus advice, 21, 154–162 results, troubleshooting, 79–80 bolus advice options. See advice options bolus, delivery, 22, buttons, 13, 15–17 data, adding, 53–55, 94–96...
  • Page 113 electromagnetic compatibility, headache, errors, list of, 224–226 health events, 26, 52–55, 91, 95, 160, 168–169 high bG retest reminder, 210, hyper warning limit, 23, 172–174, 238, fatigue, hypo warning limit, 23, 172–174, 238, frequent urination, icons, listing, 87–88, 205–206 g (grams), 181–183, infrared (IR) window, 13–14, graph, infusion set change reminder, 149–153, 210,...
  • Page 114 lab test reminder, 149–153, 211–212 pairing, 17, lancing device, 47–48 patent information, 268–271 language, 178–180 power button, 13, 15–17 lock. See key lock power-saving tips, low bG retest reminder, 211–213 pump. See insulin pump maintenance, meter, rapid heartbeat, meal rise, 160, 162, reminders, meal time, 52–55, important information,...
  • Page 115 snooze, 141, 146, 207, test results, soft keys, 13, 15–17 storing, 83–84 sound. See beeper, setting unusual, 60–61 specifications, meter, 258–259 test strip, 14, 244, standard day, reporting, 111–119 thirst, increased, standard deviation, 97–98 time blocks, 24–25, 154–167, 193–200, standard week, reporting, 120–127 time change, data, 102, 104, 107–108...
  • Page 116 vibrate, setting, 187–189 warnings, list of, 218–223 warranty, 265–267...

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