Roche Diabetes Care 876 Hand Held Blood Glucose Meter User Manual manual pt 4

Roche Diagnostics Operations, Inc. Hand Held Blood Glucose Meter manual pt 4

manual pt 4

Data Transfer and PC Reports718OverviewYou have 2options to display and analyze blood glucose results on a PC. 1. Data Transfer – this option transfers the data to special software for diabetes management in a PC. 2. PC Reports – the meter generates data reports that open in an Internet browser and can be printed.The option you select remains as the default until you change it.Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .1Press or to highlight USB Default. Press .2Press or to highlight Data Transfer. Press to move to the option. Press to set the option and return to Settings.3Chapter 8: Data Transfer and PC ReportsNOTE • You cannot perform a blood glucose test while the meter is connected to a computer with a USB cable. If you connect the meter to a PC when a test is in progress, the test is cancelled. • The meter has a port on the side for the small end of the USB cable. The large end of the USB cable is inserted into the USB port of a PC.Set Data Transfer as the Default (Main Menu > Settings > USB Default > Data Transfer)52195_AvivaConnect_FDA.indb 71 5/1/14 7:23 AM
Data Transfer and PC Reports728Set PC Reports as the Default (Main Menu > Settings > USB Default > PC Reports)Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press .1Press or to highlight USB Default. Press .2Press or to highlight PC Reports. Press to move to the option. Press to set the option and return to Settings.352195_AvivaConnect_FDA.indb 72 5/1/14 7:23 AM
Data Transfer and PC Reports738View the Data in Compatible Diabetes Management SoftwareThese steps assume that the USB default option is set to Data Transfer.The meter can be o or on.Plug the small end of the USB cable into the meter.1Plug the large end of the USB cable into a USB port on a PC.If the meter is o, it turns on.24Start the software for data analysis and initiate a data transfer.3The meter transfers the data to the software.52195_AvivaConnect_FDA.indb 73 5/1/14 7:23 AM
Data Transfer and PC Reports748NOTEIf you would like to view the data in PC Reports instead, follow these steps:1. Unplug the USB cable. Connection Lost appears.2. Press to return to Main Menu.3. Select My Data>PC Reports.4. Reconnect the USB cable.5. PC Reports appears.Plug the small end of the USB cable into the meter.1Plug the large end of the USB cable into a USB port on a PC.If the meter is o, it turns on and displays PC Reports.2View the Data on a PC (in an Internet Browser)These steps assume that USB Default is set to PC Reports.The meter can be o or on.Once the meter is disconnected from the PC, the data disappears from the PC (but not the meter) unless you save it on the PC.52195_AvivaConnect_FDA.indb 74 5/1/14 7:23 AM
Data Transfer and PC Reports758Double click on the ACCU‑CHEK drive icon.4Click on Start.html.The Internet browser opens and the default reports appear.5NOTEIf you would like to view the data in special diabetes management software instead, follow these steps:1. Unplug the USB cable. Connection Lost appears.2. Press to return to Main Menu.3. Select My Data>Data Transfer>USB Cable.4. Reconnect the USB cable.5. Data Transfer appears.Open the file manager (for example, Microsoft Windows Explorer) on the PC.The meter appears as a drive (USB storage device) in the file manager.352195_AvivaConnect_FDA.indb 75 5/1/14 7:23 AM
Data Transfer and PC Reports768ShortcutHere is a shortcut to get to Data Transfer or PC Reports. This is a quick way to transfer the data to software or to view the meter’s data on a PC.1. Turn the meter off.2. Press and hold both and until Activity appears.3. Select either Data Transfer or PC Reports.View PC ReportsOverview• An Internet connection is not necessary to view PC Reports.• When the meter and PC successfully connect, the following reports are displayed in the Internet browser:• Trend Report – This report shows the trend for several test results over the selected time period (past 3, 7, 14, 30, or 90days).• Standard Day Report – This report shows all data in a 24‑hour grid.• Standard Week Report – This report shows all blood glucose results according to the time when the test was performed and the day of the week.• List Report – The list report (record list) shows the test results sorted by date and time of the test.52195_AvivaConnect_FDA.indb 76 5/1/14 7:23 AM
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Data Transfer and PC Reports788StatisticsBelow the chart of a report, you will find a statistical analysis of all test results plotted with the following information:• Number of tests• Average• Standard deviation – The standard deviation is the variance of the analyzed results.• Highest value• Lowest value• Average tests per day – Average number of blood glucose tests per day• HI or LO – Blood glucose results outside the measuring range• Low blood glucose index or High blood glucose index – Further information can be found in References• Above target range – Blood glucose results above the target range• Within target range – Blood glucose results within the target range• Below target range – Blood glucose results below the target rangeKeyx Blood glucose resultX Several blood glucose results––– Average blood glucose results in the selected time period^ Blood glucose result above the chart range^ (red caret) Blood glucose may be higher than the measurement range of the system∨Blood glucose may be lower than the measurement range of the system(green) Your personal blood glucose target range (shown as a green bar on the PC monitor)(black) Non‑work days52195_AvivaConnect_FDA.indb 78 5/1/14 7:23 AM
Data Transfer and PC Reports798Print ReportDo not use the print function of the Internet browser. Use the Print reports button instead.Excluded DataThe following blood glucose results are not included in a report:• Test results outside the selected time period• Control results• LO or HI test results52195_AvivaConnect_FDA.indb 79 5/1/14 7:23 AM
Data Transfer and PC Reports808The Trend Report shows the trend of blood glucose results over the selected time period.The date appears on the horizontal x‑axis. The blood glucose results appear on the vertical y‑axis. The test results are connected by a thin black line in chronological order.If you set a target range in the meter, it appears as a green bar on the chart. Non‑work days are marked with diagonal slashes on the horizontal x‑axis.The trend of the day‑to‑day average blood glucose result is represented by a thick black line.52195_AvivaConnect_FDA.indb 80 5/1/14 7:23 AM
Data Transfer and PC Reports818The Standard Day Report makes it easier to recognize daily patterns. All blood glucose results are placed on a 24‑hour grid. Therefore, all tests performed at (approximately) the same time are shown at the same position on the horizontal time axis.Blood glucose results are connected by a thin black line in chronological order. A thick black line represents the trend of the average level (in intervals of 1hour if a test result falls in each interval).52195_AvivaConnect_FDA.indb 81 5/1/14 7:23 AM
Data Transfer and PC Reports828The Standard Week Report makes it easier to recognize weekly patterns. For example, you might find trends brought about by your occupation.All blood glucose results are plotted on the chart according to the time and day the test was performed. Blood glucose results are connected by a thin black line in chronological order. A thick black line represents the trend of the average level for each day.The number of tests and the daily blood glucose average are listed below the chart.52195_AvivaConnect_FDA.indb 82 5/1/14 7:23 AM
Data Transfer and PC Reports838The List Report shows the test results sorted by date and time of the test. All blood glucose results are listed chronologically with any additional information about the test result.The list contains the following columns:• Date and Time• Blood Glucose• Events – Event connected to this test result52195_AvivaConnect_FDA.indb 83 5/1/14 7:23 AM
Data Transfer and PC Reports848Working with ReportsAnalyzing Data in External ApplicationsIf you want to analyze the test results using external software, you can save the data as a CSV file (Comma Separated Values). CSV files can be opened with a text editor or spreadsheet program.The CSV file contains all test results saved in the meter. Test results transferred at an earlier date are transferred again.1. Press the Save file button on the user interface.Depending on the configuration of the PC, the CSV file may be directly opened in a spreadsheet program. In this case, you can save the data using the Save function of the spreadsheet program.2. In the dialog box that opens, select the option to save the file.Where you find the CSV file on the PC depends on the settings in the operating system for data download.The CSV file contains the following information:• Serial number: Serial number of the meter.• Download date, download time: date and time when the meter transferred the test results to the computer.• Date, time, result and unit of the results saved in the meter.• Flags added to the results, indicated by an X.In the CSV file, the date is always displayed as DD.MM.YYYY and the time as 24‑hour format (hh:mm). The time format set in the meter has no influence on the format of the date and time in the CSV file.Security Settings within the Internet BrowserThe settings of the Internet browser can influence working with reports. The reports use pages with active content (JavaScript). This active content can be suppressed by security settings in the browser, causing warnings or restricted functionality. If this happens, check the Internet browser settings.In many cases, you can create dierent security settings for using the Internet and working with reports (for example, at user login to the PC or by defining user profiles in the browser).If you select the Internet browser security settings appropriately (for example, Allow active content to run in files on My Computer), you can work with reports without any restrictions.52195_AvivaConnect_FDA.indb 84 5/1/14 7:23 AM
Data Transfer and PC Reports858NOTESome newer Internet browsers do not allow the Save function (e.g., Mozilla Firefox version 15 and higher). The files can be saved from Windows Explorer and subsequently opened using programs that are compatible with *.CSV files.TroubleshootingTroubleshooting Check ActionThe ACCU‑CHEK drive symbol with the start.html file does not appear on the PC.Check whether PC Reports is selected as the default.Check whether the PC or operating system supports data transfer via USB.Check whether the USB connector is firmly plugged into the correct port on the PC.The meter is still not detected as a drive. Plug the meter into a dierent USB port on the PC.52195_AvivaConnect_FDA.indb 85 5/1/14 7:23 AM
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Meter and Lancing Device Cleaning and Disinfecting879What is the dierence between cleaning and disinfecting?Cleaning is the removal of dirt from the meter or lancing device.3Disinfecting is the removal of most, but not all, disease‑causing and other types of microorganisms (bloodborne pathogens) from the meter or lancing device.3Approved Cleaning and Disinfecting ProductThe following product has been approved for cleaning and disinfecting the meter and lancing device:Super Sani‑Cloth (EPA*reg.no.9480‑4)Super Sani‑Cloth can be purchased from Amazon.com, Ocedepot.com, and Walmart.com.• Do not use any other cleaning or disinfecting solutions. Using solutions other than the Super Sani‑Cloth could result in damage to the meter and lancing device.• The eect of using more than one product interchangeably to clean and disinfect the meter and lancing device has not been tested. Always use Super Sani‑Cloth to clean and disinfect the meter and lancing device.• Roche has tested the approved product for a total of 260disinfection cycles, which is equal to disinfecting once per week over a 5year period.*Environmental Protection AgencyChapter 9: Meter and Lancing Device Cleaning and Disinfecting52195_AvivaConnect_FDA.indb 87 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting889NOTEFor technical assistance or questions on cleaning and disinfecting, contact the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072.Cleaning and Disinfecting the MeterWARNINGIf the meter is being operated by a second person who is providing testing assistance to the user, the meter and lancing device should be cleaned and disinfected prior to use by the second person.To clean and disinfect without damaging the meter, follow these procedures carefully.When to Clean and Disinfect the Meter• Clean the meter to remove visible dirt or other material prior to disinfecting.• Clean and disinfect the meter at least once per week and when blood is present on the surface of the meter.• Clean and disinfect the meter before allowing anyone else to handle the meter. Do not allow anyone else to use the meter on themselves for testing purposes.NOTEUsing cleaning and disinfecting products could result in damage to the meter. If you notice any of the following signs of deterioration after cleaning and disinfecting your meter, stop using your meter and contact the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072: residue around buttons, clouding of display, button malfunction, out‑of‑range control results.What to Clean and DisinfectThe following parts of the meter should be cleaned and disinfected:• The area around slots and openings (do not get any moisture in slots or openings)• The meter display• The entire meter surface52195_AvivaConnect_FDA.indb 88 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting899How to Clean and Disinfect the Meter WARNINGFailure to follow these instructions will damage the meter and stop it from working properly.• DO NOT clean or disinfect the meter while performing a blood glucose or control test.• DO NOT get any moisture in slots or openings.• DO NOT spray anything onto the meter.• DO NOT immerse the meter in liquid.• Always use the same product for both cleaning and disinfecting.Wash hands thoroughly with soap and water.1Turn the meter off and wipe the entire meter surface with a Super Sani‑Cloth. Carefully wipe around the test strip slot and other openings.Make sure that no liquid enters any slot or opening.2A separate Super Sani‑Cloth should be used for cleaning and disinfection. For disinfecting the meter, get a new cloth and repeat step2, making sure the surface stays wet for 2minutes. Make sure that no solution is seen in any slot or opening.352195_AvivaConnect_FDA.indb 89 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting909Wash hands thoroughly with soap and water.452195_AvivaConnect_FDA.indb 90 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting919Cleaning and Disinfecting the Lancing DeviceTo clean and disinfect without damaging the lancing device, follow these procedures carefully.When to Clean and Disinfect the Lancing Device• Clean the lancing device to remove visible dirt or other material prior to disinfecting.• Clean and disinfect the lancing device at least once per week to remove visible dirt or other material for safe handling.• Clean and disinfect the lancing device before allowing anyone else to handle the lancing device, for instance, if you have someone assisting you. Do not allow anyone else to use the lancing device.NOTE• Do not throw away the cap after each use. Use the approved cleaning and disinfecting product on the cap.• Always remove the lancet drum before cleaning or disinfecting the lancing device.• Using cleaning and disinfecting products could result in damage to the lancing device. If you notice any of the following signs of deterioration after cleaning and disinfecting your lancing device, stop using your lancing device and contact the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072: residue around buttons, diculty in priming the device, diculty in inserting the lancet drum.• You might observe a slight discoloration of the lancing device after multiple cleaning and disinfecting cycles. This does not aect the functionality of the lancing device.What to Clean and DisinfectThe following parts of the lancing device should be cleaned and disinfected:• The entire lancing device surface• The cap52195_AvivaConnect_FDA.indb 91 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting929How to Clean and Disinfect the Lancing DeviceWARNINGFailure to follow these instructions may damage the lancing device and stop it from working properly.• DO NOT get any moisture into any openings.• Always use the same product for both cleaning and disinfecting.Wash hands thoroughly with soap and water.1Wipe the entire surface of the lancing device and the inside of the cap with an approved cleaning and disinfecting product. 2A separate Super Sani‑Cloth should be used for cleaning and disinfection. For disinfecting the lancing device, use a new cloth and repeat step2 making sure the surface stays wet for 2minutes.352195_AvivaConnect_FDA.indb 92 5/1/14 7:23 AM
Meter and Lancing Device Cleaning and Disinfecting939Wash hands thoroughly with soap and water.452195_AvivaConnect_FDA.indb 93 5/1/14 7:23 AM
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Meter Maintenance and Troubleshooting9510Meter MaintenanceThe meter automatically tests its own systems every time you turn it on and lets you know if something is wrong. See Error Messages in this chapter.If you have problems with the meter or think the results are not accurate, perform a control test with an unexpired test strip and control solution. If the control result is not within the acceptable range, contact the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072.Changing the BatteriesChapter 10: Meter Maintenance and TroubleshootingUse your thumb to slide the battery drawer out of the meter.1Remove the old batteries and place the new ones in the battery drawer with the (+)side facing down.2Slide the battery drawer back into position until it locks into place.3NOTE• The meter uses two3‑volt lithium batteries, coin cell typeCR2032. This type of battery can be found in many stores. It is a good idea to have spare batteries available.• Always replace both batteries at the same time and with the same brand.• The logbook data is saved when you replace the batteries.52195_AvivaConnect_FDA.indb 95 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting9610Error MessagesWARNINGNever make therapy decisions based on an error message.The meter is connected to a PC and a test cannot be performed.EITHER remove the USB cable and perform a test OR remove the test strip and start a data transfer.The meter will not turn on or the display is blank.Batteries are dead.Insert new batteries.Display is damaged. / Meter is defective.Contact the ACCU‑CHECK Customer Care Service Center at 1‑800‑858‑8072.Extreme temperatures.Move the meter to a more temperate area.The connection between the meter and PC was lost.Disconnect and reconnect the USB cable and retry the connection. Contact the ACCU‑CHEK Customer Care Service Center if the connection is lost again.52195_AvivaConnect_FDA.indb 96 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting9710There is no connection between the meter and PC.Connect the USB cable and retry the connection.Blood glucose results were not transferred to a paired device.Make sure the paired device is within range of the meter and turned on.Data could not be transferred from the meter to the PC.Check the PC or USB cable.Data cannot be sent to a paired device because the meter is in Flight Mode.Retry the data transfer when the meter is not in Flight Mode.One or more blood glucose results are excluded from the selected averages because the results are invalid or out of the system measurement range.The date entered is not valid.Enter the correct date.52195_AvivaConnect_FDA.indb 97 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting9810A meter setting was changed while in Flight Mode.The setting change will not take eect until Flight Mode is turned o.Pairing to a device cannot be performed while in Flight Mode.Retry pairing when the meter is not in Flight Mode.The blood glucose result has not been sent to the default paired device. The transfer is still pending.Place meter and paired device closer together.The meter was unable to pair with a device.Retry the pairing.The test strip may be damaged or not properly inserted.Remove and reinsert the test strip or replace it if damaged.52195_AvivaConnect_FDA.indb 98 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting9910and above the system’s reading range. Contact your healthcare professional immediately.• If the second test result does not match how you feel, perform a control test with the control solution and a new test strip.• If the control result is within the acceptable range, review the proper testing procedure and repeat the blood glucose test with a new test strip.• If the control result is not within the acceptable range, see the Understanding Out‑of‑Range Control Results section in the chapter Control Tests.Your blood glucose may be extremely high or a meter or a test strip error has occurred.• If your test result matches how you feel, contact your healthcare professional immediately.• If your test result does not match how you feel, repeat the blood glucose test. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.• If the E‑3code still appears for your blood glucose test, your blood glucose result may be extremely high A meter or test strip error has occurred.52195_AvivaConnect_FDA.indb 99 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting10010Not enough blood or control solution was drawn into the test strip for measurement or was applied after the test had started.Discard the test strip and repeat the blood glucose or control test.The blood or control drop was applied to the test strip too late.Discard the test strip and repeat the blood glucose or control test.Blood or control solution was applied to the test strip before Apply drop appeared.Discard the test strip and repeat the blood glucose or control test.An electronic error occurred, or in rare cases, a used test strip was removed and reinserted.Remove the batteries, press any button, and reinsert the batteries. Perform a blood glucose or control test.The temperature is above or below the proper range for the system.Refer to the test strip package insert for system operating conditions. Move to an area with the appropriate conditions, wait 5minutes, and repeat the blood glucose or control test. Do not artificially heat or cool the meter.52195_AvivaConnect_FDA.indb 100 5/1/14 7:23 AM
Meter Maintenance and Troubleshooting10110The batteries are out of power.Change the batteries now. If the message reappears after the batteries have been replaced, slide the battery drawer out of the meter, press any meter button, then reinsert the battery drawer into position.The time and date setting may be incorrect.Make sure the time and date are correct and adjust, if necessary.The meter time and date have been changed to match the paired device.There are no results in the Logbook.There is an invalid result in the Logbook.52195_AvivaConnect_FDA.indb 101 5/1/14 7:24 AM
Meter Maintenance and Troubleshooting10210There are no results in range for the selected average.Blood glucose may be higher than the measurement range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.Blood glucose may be lower than the measurement range of the system. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests.52195_AvivaConnect_FDA.indb 102 5/1/14 7:24 AM
Technical Information10311Product LimitationsSee the literature packaged with the test strips and control solutions for the latest information on product specifications and limitations.SpecificationsBlood volumeSample typeMeasuring timeMeasurement rangeTest strip storage conditionsSystem operating conditionsRefer to the test strip package insert.Meter storage conditions Temperature: ‑13–158°FMemory capacity 750blood glucose results and 30control results with time and dateAutomatic o 90secondsPower supply Two3‑volt lithium batteries (coin cell type CR2032)Display LCDDimensions 80 × 47 × 19 mm (LWH)Weight Approx. 40g (with batteries)Construction Hand‑heldProtection class IIIMeter type The ACCU‑CHEK Aviva Connect meter is suitable for continuous operation.Control solution storage conditions Refer to the control solution package insert.Chapter 11: Technical Information52195_AvivaConnect_FDA.indb 103 5/1/14 7:24 AM
Technical Information10411Bluetooth® Wireless Technology The meter uses Bluetooth smart class II wireless technology to communicate and transfer information. Bluetooth wireless technology is a form or 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 other devices, such as a smartphone, is not an open channel. The meter can only communicate with the device that 1. is Bluetooth smart, 2. it is paired with, and 3. has an application that can accept the meter’s data. This device complies with United States Federal Communication Commission (FCC) standards. The device complies with FCC Part 15 Rules. Operation of the device is subject to the following conditions: 1. This device may not cause harmful interference and 2. must accept any interference received, including interference that may cause undesired operation. Compliance with these guidelines means that under normal, daily circumstances, the device should not aect the operation of other devices. In addition, the device should operate normally in the presence of other devices. In the event there is interference from another device, it is recommended that you increase the distance between the meter and that device. You can also turn o the interfering device. In addition, you can turn o Bluetooth wireless technology on the meter. Changes or modifications to the device not expressly approved by Roche could void the user’s authority to operate the device. The device has been tested and found to comply with the limits for a Class B digital device. The device generates, uses, and can radiate radio frequency energy.52195_AvivaConnect_FDA.indb 104 5/1/14 7:24 AM
Technical Information10511Electromagnetic Compatibility – This meter meets the electromagnetic immunity requirements as per ENISO15197. The chosen basis for electrostatic discharge immunity testing was basic standard IEC61000‑4‑2. In addition, the meter meets the electromagnetic emissions requirements as per EN61326. The meter’s electromagnetic emission is thus low. Interference from the meter to other electrically‑driven equipment is not anticipated.This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.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.NOTEThis equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment o and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver.• Connect the equipment into an outlet on a circuit dierent from that to which the receiver is connected.• Consult the dealer or an experienced radio/TV technician for help.Changes or modifications not expressly approved by the party responsible for compliance (i.e. the manufacturer) could void the user’s authority to operate the equipment.Performance Analysis – Refer to the test strip package insert.Test Principle – Refer to the test strip package insert.52195_AvivaConnect_FDA.indb 105 5/1/14 7:24 AM
Technical Information10611Product Safety InformationWARNING• This meter meets IEC 61010‑1, IEC61010‑101 and IEC 609501‑1 safety standards.• Strong electromagnetic fields may interfere with the proper operation of the meter. Do not use the meter close to sources of strong electromagnetic radiation.• To avoid electrostatic discharge, do not use the meter in a very dry environment, especially one in which synthetic materials are present.Travel DocumentationIf you are traveling on a commercial airline, you may be required to provide documentation certifying that this meter meets environmental conditions and test procedures for Airborne Equipment (RTCA DO‑160) section21 Emission of Radio Frequency Energy. Visit accu‑chek.com or contact the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072 to obtain a copy of the document. Discarding the Meter, Test Strips, Lancing Devices, Lancets, and BatteriesWARNING• Any product coming in contact with blood is considered contaminated (potentially infectious).*• During normal testing, any blood glucose meter may come in contact with blood.• Lancing devices may also be considered sharps. Disposal of sharps is regulated by law in many jurisdictions.Roche is committed to recycling and sustainability. Comply with any laws or ordinances relating to the disposal of sharps and/or contaminated products. Contact your local health department or other appropriate authorities for proper handling and disposal of used meters, used test strips, used lancets, and used batteries. Consider the following points when discarding used testing materials:Consider recycling the meters and batteries at an appropriate facility. Be aware the meter is potentially hazardous electronics scrap (e‑scrap) and should be disposed of accordingly. The batteries are potentially hazardous also and should be discarded accordingly.Disinfect the meter before recycling or discarding.*29CFR1910.1030 – Bloodborne pathogens52195_AvivaConnect_FDA.indb 106 5/1/14 7:24 AM
Technical Information10711Explanation of SymbolsCaution, refer to safety‑related notes in the instructions for use accompanying this product.3‑volt coin cell type CR2032Additional SuppliesTest Strips: ACCU‑CHEK Aviva Plus test stripsControl Solutions: ACCU‑CHEK Aviva control solutionsLancets: ACCU‑CHEK FastClix 102‑ct. lancet drums (17‑6 ct. drums)Low Blood Glucose Index or High Blood Glucose Index4,5,6These figures represent the frequency and the resulting risk of blood glucose values being too low or too high. Figures should be as low as possible.The following table provides an overview to assess the risk of blood glucose values being too low or too high:Risk Low blood glucose index High blood glucose indexminimal ≤1.1 ≤5.0low 1.1–2.5 5.0–10.0medium 2.5–5.0 10.0–15.0high >5.0 >15.0WARNINGThe index values for low blood glucose or high blood glucose in the table are not blood glucose values. Ask your healthcare professional if you want to change your therapy based on the index values.52195_AvivaConnect_FDA.indb 107 5/1/14 7:24 AM
Technical Information10811References1 FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication, (2010). Update 11/29/2010.” http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm. Accessed March 20, 2012.2 CDC Clinical Reminder: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens, (2010).” http://www.cdc.gov/injectionsafety/Fingerstick‑DevicesBGM.html. Accessed March 20, 2012.3 Healthcare Infection Control Practices Advisory Committee (HICPAC), William A. Rutala, Ph.D., M.P.H., and David J. Weber, M.D., M.P.H. Centers for Disease Control and Prevention, 2008. “Guideline for Disinfection and Sterilization in Healthcare Facilities.” Atlanta.4 Boris P. Kovatchev, Martin Straume, Daniel J. Cox, Leon S. Farhy (2001) “Risk analysis of blood glucose data: a quantitative approach to optimizing the control of insulin dependent diabetes.” Journal of Theoretical Medicine, 3: pp 1‑10.5 Boris P. Kovatchev, Daniel J. Cox, Anand Kumar, Linda Gonder‑Frederick, William L. Clarke (2003) “Algorithmic Evaluation of Metabolic Control and Risk of Severe Hypoglycemia in Type 1 and Type 2 Diabetes Using Self‑Monitoring Blood Glucose Data.” Diabetes Technology & Therapeutics, 5(5): pp 817‑828.6 Boris P. Kovatchev (2006) “Is Glycemic Variability Important to Assessing Antidiabetes Therapies.” Current Diabetes Reports, 6: pp 350‑356.52195_AvivaConnect_FDA.indb 108 5/1/14 7:24 AM
License and Warranty10912WarrantyACCU‑CHEK Aviva Connect Meter 30‑day Money‑back Guarantee for Qualifying ConsumersRoche Diagnostics oers qualifying consumers that purchase an ACCU‑CHEK Aviva Connect meter, a 30‑day money back guarantee. If you are not fully satisfied with your ACCU‑CHEK Aviva Connect meter, contact the ACCU‑CHEK Customer Care Service Center toll‑free at 1‑800‑858‑8072 to determine whether you qualify to receive a full refund within 30 days of purchase. If you are covered under Medicare, Medicaid, other federal/state programs, or private insurance you are NOT eligible for this money‑back oer. Consumers aected by this exclusion may instead request a dierent ACCU‑CHEK meter/system. The refund will be limited to the amount paid by you net of any rebates. You must have a copy of the dated itemized purchase receipt and the original packaging to obtain this refund.ACCU‑CHEK Aviva Connect Meter Limited 3‑Year WarrantyRoche Diagnostics warrants to the original purchaser of the meter that your ACCU‑CHEK Aviva Connect meter will be free from defects in materials and workmanship for three years from the date of purchase. If, during this 3‑year period, the meter does not work properly because of a defect in materials or workmanship, Roche Diagnostics will replace it with a new ACCU‑CHEK Aviva Connect 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 Connect meter shall be replacement.This warranty does not apply to the performance of an ACCU‑CHEK Aviva Connect meter that has been damaged by accident or has been altered, misused, tampered with, or abused in any way. Roche Diagnostics will handle meters that show damage or abuse according to its Non‑Warranty Service Policy described on the following page.THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES, AND ROCHE DIAGNOSTICS 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 ROCHE DIAGNOSTICS 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. 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 exclusion of incidental or consequential damages, so the above limitation and exclusion may not apply to you. This warranty gives you specific legal rights, which vary from state to state.Chapter 12: License and Warranty52195_AvivaConnect_FDA.indb 109 5/1/14 7:24 AM
License and Warranty11012Non‑Warranty Service PolicyRoche Diagnostics Non‑Warranty Service Policy applies to meters where the above warranty has not become eective, has become inapplicable, or has expired. Roche Diagnostics will replace, at its option, meters returned to it for a service charge (not to exceed $35).Replacement will be with the same or similar product. Replacement meters will be warranted for a period of 90 days from shipment under a limited warranty providing for replacement of parts and labor at no charge.Warranty and Service InstructionsAll requests for return of ACCU‑CHEK Aviva Connect meters under the above warranty or service policy must be made to the ACCU‑CHEK Customer Care Service Center. You will be mailed a return authorization label, which must be axed to your carton for shipping the system to Roche Diagnostics. Cartons received without this label will be returned to you at your expense.Customers experiencing diculties should review the troubleshooting information in Meter Maintenance and Troubleshooting of this manual. Further inquiries should be directed to the ACCU‑CHEK Customer Care Service Center.Be sure to fill out and mail the Warranty Card that comes with the ACCU‑CHEK Aviva Connect system.52195_AvivaConnect_FDA.indb 110 5/1/14 7:24 AM
License and Warranty11112Limited LicenseWARNINGCAUTION – A RESTRICTED LICENSE LIMITS USE OF THE ACCU‑CHEK AVIVA CONNECT SYSTEM IN THE UNITED STATES – READ CAREFULLY THE LIMITATIONS RECITED BELOW.The ACCU‑CHEK Aviva Connect system (meter and test strips) and its use are protected by U.S. Patent Nos. 6,645,368 (expires 22‑December‑2017); 7,276,146 (expires 4‑October‑2022); 7,276,147 (expires 4‑October‑2022); 7,407,811 (expires 9‑May‑2020); 8,298,401 (expires 4‑October‑2022); 8,303,801 (expires 4‑October‑2022); 8,329,026 (expires 4‑October‑2022); 7,452,457 (expires 2‑May‑2026); 7,488,601 (expires 1‑February‑2026); 7,494,816 (expires 29‑December‑2019); 7,569,126 (expires 28‑December‑2026); and 7,604,721 (expires 12‑August‑2026). A license to use the ACCU‑CHEK Aviva Connect system is required until the expiration of the last‑to‑expire patent listed above and is only granted when the ACCU‑CHEK Aviva Connect meter is used with the ACCU‑CHEK Aviva Plus test strips.ACCU‑CHEK Aviva Plus test strips are specifically manufactured for operation with the ACCU‑CHEK Aviva Connect meter. Use of other test strips supplied by another manufacturer may prevent or impair the proper function of the ACCU‑CHEK Aviva Connect system.Using the ACCU‑CHEK Aviva Connect system indicates your acceptance of the restricted license to use the ACCU‑CHEK Aviva Connect system only with ACCU‑CHEK Aviva Plus test strips. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused ACCU‑CHEK Aviva Connect system for a full refund. If you have any questions, please call the ACCU‑CHEK Customer Care Service Center at 1‑800‑858‑8072.Except where prohibited by statute, all warranties covering the ACCU‑CHEK Aviva Connect system are voided by use of the ACCU‑CHEK Aviva Connect system with any test strips other than ACCU‑CHEK Aviva Plus test strips.WARNINGA RESTRICTED LICENSE LIMITS USE OF THE ACCU‑CHEK FASTCLIX SYSTEM (lancing device and lancet drums). READ CAREFULLY THE LIMITATIONS RECITED BELOW.The ACCU‑CHEK FastClix system (device and lancet drums) and its use are protected by U.S. Patent Nos 7,322,998 (expires 3‑March‑2020); and 7,785,338 (expires 5‑January‑2026). A license to use the ACCU‑CHEK FastClix system is required until the expiration of the last‑to‑expire patent listed above and is only granted when ACCU‑CHEK FastClix lancet drums are used with the ACCU‑CHEK FastClix device.52195_AvivaConnect_FDA.indb 111 5/1/14 7:24 AM
License and Warranty11212ACCU‑CHEK FastClix lancet drums are high precision components that are produced to the close tolerances required for satisfactory operation with the ACCU‑CHEK FastClix device. Use of other lancet drums with the ACCU‑CHEK FastClix device may prevent or impair proper function of the ACCU‑CHEK FastClix device.Using the ACCU‑CHEK FastClix device indicates your acceptance of the restricted license to use the ACCU‑CHEK FastClix device only with ACCU‑CHEK FastClix lancet drums. Further, if you have purchased an ACCU‑CHEK FastClix device that includes this restricted license, then this restricted license applies regardless of any additional oers found in ACCU‑CHEK FastClix device packages. If you do not agree to the terms and conditions of the restricted license, you may return, at the place of purchase, the unused ACCU‑CHEK FastClix device for a full refund. If you have any questions, contact the ACCU‑CHEK Customer Care Services Center at 1‑800‑858‑8072.Except where prohibited by statute, all warranties covering the ACCU‑CHEK FastClix device are voided by use of the ACCU‑CHEK FastClix device with any lancet drums other than ACCU‑CHEK FastClix lancet drums. Patent InformationU.S. Pat.: http://www.roche‑diagnostics.us/patents52195_AvivaConnect_FDA.indb 112 5/1/14 7:24 AM
License and Warranty1131252195_AvivaConnect_FDA.indb 113 5/1/14 7:24 AM
License and Warranty1141252195_AvivaConnect_FDA.indb 114 5/1/14 7:24 AM
Index115Aaverages 54Bbatteries, changing 95battery drawer 95battery type 95blood glucose index 107blood glucose results, unusual 37blood glucose test, performing 31button, functions 12Ccomfort dial 25control results, out‑of‑range 24control solution 19control test, performing 20Ddata transfer default 71Hhigh blood glucose 38hyperglycemia 38hypoglycemia 38Iicons 15Llancet drum, changing 28lancet drum, inserting 26lancing device, cleaning and disinfecting 91lancing device, using 27logbook 52low blood glucose 38Mmaintenance, meter 95meter, cleaning and disinfecting 88Ppc reportsdefault 72list report 83standard day report 81standard week report 82trend 80product limitations 103product safety information 105product specifications 103Ssafety information 3settings, meter 39beeper 42language 49last result 48markers 45target range 46time/date 41USB default 44supplies 107symbols 107symptoms, hypoglycemia/hyperglycemia 38Index52195_AvivaConnect_FDA.indb 115 5/1/14 7:24 AM
Index116Ttechnical information 103test strips 30Uuse by date 19, 30Vview data, pc internet browser 74view data in software 73view pc reports 76Wwarranty 110wireless communication 57auto‑send 62default device 61delete paired device 67flight mode 60pair additional device 64pairing 58sync time 6352195_AvivaConnect_FDA.indb 116 5/1/14 7:24 AM
Notes11752195_AvivaConnect_FDA.indb 117 5/1/14 7:24 AM
Notes11852195_AvivaConnect_FDA.indb 118 5/1/14 7:24 AM
52195_Book_Bridge_US_CVR.indb 3 4/28/14 2:25 PM
Roche Diagnostics9115 Hague RoadIndianapolis, IN 46256www.accu-chek.comACCU-CHEK, ACCU-CHEK AVIVA, ACCU-CHEK AVIVA CONNECT and FASTCLIX are trademarks of Roche. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Roche is under license. Other trademarks and tradenames are those of their respective owners.© 2014 Roche Diagnostics52195-0514Continua Certified signifies that this product complies with applicable IEEE 11073-10417 standards and that it has been tested and certified against the 2014 Continua Design Guidelines.52195_Book_Bridge_US_CVR.indb 4 4/28/14 2:25 PM

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