Data Transfer and PC Reports 8 Overview You have 2 options to display and analyze blood glucose results on a PC. 1. D ata 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. NOTE • You cannot perform a blood glucose test while the meter is connected to a computer with a USB cable.
8 Data Transfer and PC Reports Set PC Reports as the Default (Main Menu > Settings > USB Default > PC Reports) 1 2 3 Turn the meter on by briefly pressing . From Main Menu, press to highlight Settings. Press . Press or to highlight USB Default. Press . Press or to highlight PC Reports. Press to move to the option. Press to set the option and return to Settings. 72 52195_AvivaConnect_FDA.
Data Transfer and PC Reports 8 View the Data in Compatible Diabetes Management Software These steps assume that the USB default option is set to Data Transfer. The meter can be off or on. 1 2 3 Plug the small end of the USB cable into the meter. Plug the large end of the USB cable into a USB port on a PC. Start the software for data analysis and initiate a data transfer. If the meter is off, it turns on. 4 The meter transfers the data to the software. 73 52195_AvivaConnect_FDA.
8 Data Transfer and PC Reports NOTE If 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. View the Data on a PC (in an Internet Browser) These steps assume that USB Default is set to PC Reports. The meter can be off or on.
Data Transfer and PC Reports 3 4 5 Open the file manager (for example, Microsoft Windows Explorer) on the PC. Double click on the ACCU-CHEK drive icon. Click on Start.html. The meter appears as a drive (USB storage device) in the file manager. 8 The Internet browser opens and the default reports appear. NOTE If 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.
8 Data Transfer and PC Reports Shortcut Here 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 Reports Overview • An Internet connection is not necessary to view PC Reports.
Data Transfer and PC Reports 8 77 52195_AvivaConnect_FDA.
Data Transfer and PC Reports Statistics Below 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.
Data Transfer and PC Reports 8 Print Report Do not use the print function of the Internet browser. Use the Print reports button instead. Excluded Data The following blood glucose results are not included in a report: • Test results outside the selected time period • Control results • LO or HI test results 79 52195_AvivaConnect_FDA.
8 Data Transfer and PC Reports The 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.
Data Transfer and PC Reports 8 The 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).
8 Data Transfer and PC Reports The 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.
Data Transfer and PC Reports 8 The 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 result 83 52195_AvivaConnect_FDA.
8 Data Transfer and PC Reports Working with Reports Analyzing Data in External Applications If 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.
Data Transfer and PC Reports 8 NOTE Some 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. Troubleshooting Troubleshooting Check Action The ACCU-CHEK drive symbol with the start.html file does not appear on the PC. Check whether PC Reports is selected as the default.
8 Data Transfer and PC Reports 86 52195_AvivaConnect_FDA.
Meter and Lancing Device Cleaning and Disinfecting 9 What is the difference between cleaning and disinfecting? Cleaning is the removal of dirt from the meter or lancing device.3 Disinfecting is the removal of most, but not all, disease‑causing and other types of microorganisms (bloodborne pathogens) from the meter or lancing device.3 Approved Cleaning and Disinfecting Product The following product has been approved for cleaning and disinfecting the meter and lancing device: Super Sani‑Cloth (EPA* reg. no.
9 Meter and Lancing Device Cleaning and Disinfecting NOTE For 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 Meter WARNING If 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.
Meter and Lancing Device Cleaning and Disinfecting 9 How to Clean and Disinfect the Meter WARNING Failure 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.
9 Meter and Lancing Device Cleaning and Disinfecting 4 Wash hands thoroughly with soap and water. 90 52195_AvivaConnect_FDA.
Meter and Lancing Device Cleaning and Disinfecting 9 Cleaning and Disinfecting the Lancing Device To 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.
9 Meter and Lancing Device Cleaning and Disinfecting How to Clean and Disinfect the Lancing Device WARNING Failure 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. 1 Wash hands thoroughly with soap and water. 2 Wipe the entire surface of the lancing device and the inside of the cap with an approved cleaning and disinfecting product.
Meter and Lancing Device Cleaning and Disinfecting 9 4 Wash hands thoroughly with soap and water. 93 52195_AvivaConnect_FDA.
9 Meter and Lancing Device Cleaning and Disinfecting 94 52195_AvivaConnect_FDA.
Chapter 10: Meter Maintenance and Troubleshooting Meter Maintenance and Troubleshooting 10 Meter Maintenance The 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.
10 Meter Maintenance and Troubleshooting Error Messages WARNING Never make therapy decisions based on an error message. 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 meter is connected to a PC and a test cannot be performed. The connection between the meter and PC was lost.
Meter Maintenance and Troubleshooting 10 There is no connection between the meter and PC. Blood glucose results were not transferred to a paired device. Data could not be transferred from the meter to the PC. Connect the USB cable and retry the connection. Make sure the paired device is within range of the meter and turned on. Check the PC or USB cable. Data cannot be sent to a paired device because the meter is in Flight Mode.
10 Meter Maintenance and Troubleshooting A meter setting was changed while in Flight Mode. Pairing to a device cannot be performed while in Flight Mode. The setting change will not take effect until Flight Mode is turned off. Retry pairing when the meter is not in Flight Mode. The meter was unable to pair with a device. The test strip may be damaged or not properly inserted. Retry the pairing. Remove and reinsert the test strip or replace it if damaged.
Meter Maintenance and Troubleshooting 10 A meter or test strip error has occurred. 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.
10 Meter Maintenance and Troubleshooting Not 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.
Meter Maintenance and Troubleshooting The batteries are out of power. The time and date setting may be incorrect. 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. 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.
10 Meter Maintenance and Troubleshooting There are no results in range for the selected average. Blood glucose may be higher than the measurement range of the system. 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. See the Unusual Blood Glucose Results section in the chapter Blood Glucose Tests. 102 52195_AvivaConnect_FDA.
Technical Information 11 Product Limitations See the literature packaged with the test strips and control solutions for the latest information on product specifications and limitations. Specifications Blood volume Refer to the test strip package insert.
11 Technical Information Bluetooth® 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.
Technical Information 11 Electromagnetic 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.
11 Technical Information Product Safety Information WARNING • 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.
Technical Information 11 Explanation of Symbols Caution, refer to safety‑related notes in the instructions for use accompanying this product. 3‑volt coin cell type CR2032 Additional Supplies Test Strips: ACCU‑CHEK Aviva Plus test strips Control Solutions: ACCU‑CHEK Aviva control solutions Lancets: ACCU‑CHEK FastClix 102-ct. lancet drums (17-6 ct.
11 Technical Information References 1 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.
License and Warranty 12 Warranty ACCU‑CHEK Aviva Connect Meter 30‑day Money‑back Guarantee for Qualifying Consumers Roche Diagnostics offers 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.
12 License and Warranty Non‑Warranty Service Policy Roche Diagnostics Non‑Warranty Service Policy applies to meters where the above warranty has not become effective, 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.
License and Warranty 12 Limited License WARNING CAUTION – 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.
12 License and Warranty ACCU‑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.
License and Warranty 12 113 52195_AvivaConnect_FDA.
12 License and Warranty 114 52195_AvivaConnect_FDA.
Index A averages 54 logbook 52 low blood glucose 38 B M batteries, changing 95 battery drawer 95 battery type 95 blood glucose index 107 blood glucose results, unusual 37 blood glucose test, performing 31 button, functions 12 maintenance, meter 95 meter, cleaning and disinfecting 88 P C comfort dial 25 control results, out-of-range 24 control solution 19 control test, performing 20 pc reports default 72 list report 83 standard day report 81 standard week report 82 trend 80 product limitations 103
Index T technical information 103 test strips 30 U use by date 19, 30 V view data, pc internet browser 74 view data in software 73 view pc reports 76 W warranty 110 wireless communication 57 auto-send 62 default device 61 delete paired device 67 flight mode 60 pair additional device 64 pairing 58 sync time 63 116 52195_AvivaConnect_FDA.
Notes 117 52195_AvivaConnect_FDA.
Notes 118 52195_AvivaConnect_FDA.
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Continua 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. Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256 www.accu-chek.com ACCU-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.
