WX3-816Hand Held Blood Glucose Meter

User’s Manual ACCU‑CHEK ® Aviva Insight Diabetes Manager Roche USA – 52297 V6/1 – 07167776001 – Black Roche USA – 52297 V6/2 – 07167776001 – Cyan Roche USA – 52297 V6/3 – 07167776001 – Magenta Roche USA – 52297 V6/4 – 07167776001 – Yellow 52297_07167776001.indb 110/20/14 11:17 AM 52297_07167776001.indb 210/20/14 11:17 AM I Contents 1 Important Safety Information 1 1.1 The ACCU‑CHEK Aviva Insight System 1 1.2 Special Information for Caregivers 8 1.3 Before You Start Testing 9 2 Understanding Your Diabetes Manager 11 2.1 About This User’s Manual 11 2.2 The ACCU‑CHEK Aviva Insight Diabetes Manager at a Glance 12 2.3 Home Screen 16 2.4 Turning the Meter On or Off and Power Management 21 2.5 Navigation 24 2.6 Quick Notes Screen 29 2.7 Using the Test Strips 30 2.8 Summary of Features 33 3 Startup 35 3.1 Before You Get Started 35 3.2 Charging the Battery 36 3.3 Setup Wizard 41 3.4 Completing the Setup Wizard 43 3.5 Important Information 50 4 Control Testing 57 4.1 When to Perform a Control Test 57 4.2 About the Control Solutions 58 4.3 Performing a Control Test 59 4.4 Out‑of‑Range Control Results 63 5 Testing Your Blood Glucose 67 5.1 Performing a Blood Glucose Test 67 5.2 Adding Information to a Blood Glucose Result 73 5.3 Delivering a Bolus Without Bolus Advice 76 5.4 Understanding Blood Glucose Results 79 5.5 Unusual Blood Glucose Results 83 5.6 Symptoms of Low or High Blood Glucose 85 52297_07167776001.indb 110/20/14 11:17 AM II 6 Bolus Advice 87 6.1 Overview 87 6.2 Before Using Bolus Advice 88 6.3 Delivering a Bolus Using Bolus Advice 91 7 Changing Bolus Advice Settings 101 7.1 Overview 101 7.2 Setting Up Bolus Advice 103 7.3 Bolus Advice: Time Block Settings 109 7.4 Bolus Advice: Adding a Time Block 113 7.5 Bolus Advice: Deleting Time Blocks 119 7.6 Bolus Advice: Resetting All Time Blocks 128 7.7 Health Event Percentages 134 7.8 Advice Options: Meal Rise, Snack Size, Acting Time, Offset Time 136 7.9 Turning Off Bolus Advice 138 8 Changing Meter Settings 139 8.1 Overview 139 8.2 Date, Time, and Time Format 141 8.3 Mode Settings: Sound, Vibration 142 8.4 Mode Settings: Signal Suspension 144 8.5 Home Screen Default 146 8.6 Touchscreen: Tone, Vibration 147 8.7 Brightness 148 8.8 Background Color 149 8.9 Language 150 8.10 Time Block Settings 151 8.11 Adding a Time Block 154 8.12 Deleting Time Blocks 159 8.13 Resetting All Time Blocks 168 8.14 Warning Limits: Hypo, Hyper 173 8.15 Insulin Increment 175 8.16 Max Bolus Amount 176 8.17 Carbohydrate Unit 178 52297_07167776001.indb 210/20/14 11:17 AM III 9 Meter Reminders 179 9.1 Overview 179 9.2 Blood Glucose Test Reminder: After Meal 182 9.3 Blood Glucose Test Reminder: After High Blood Glucose Result 184 9.4 Blood Glucose Test Reminder: After Low Blood Glucose Result 186 9.5 Doctor Visit Reminder 188 9.6 Lab Test Reminder 190 9.7 Customized Reminder 192 9.8 Alarm Clock Reminder 195 9.9 Medication Reminder 199 10 Communication 203 10.1 Overview 203 10.2 Connecting the Meter to a PC using a USB Cable 204 10.3 Changing USB Cable Connection Settings 207 11 Travel Settings 209 11.1 Overview 209 11.2 Turning On Flight Mode 210 11.3 Turning Off Flight Mode 211 12 My Data 213 12.1 Overview 213 12.2 The Logbook 214 12.3 The Trend Graph 229 12.4 The Standard Week 237 12.5 The Standard Day 244 12.6 Target Data 250 12.7 The bG Averages Table 255 13 Cleaning and Disinfecting the Meter and Lancing Device 261 13.1 Overview 261 13.2 Cleaning and Disinfecting the Meter 263 13.3 Cleaning and Disinfecting the Lancing Device 267 14 Care and Maintenance 271 14.1 Overview 271 14.2 Charging the Battery 271 14.3 Power‑Saving Tips 272 14.4 Changing the Battery 273 14.5 Touchscreen Calibration 276 14.6 Meter Function Test 278 52297_07167776001.indb 310/20/14 11:17 AM IV 15 Troubleshooting 281 15.1 Overview 281 15.2 Troubleshooting the Meter 282 16 Technical Information 299 16.1 Product Limitations 299 16.2 Specifications 299 16.3 Product Safety Information 304 16.4 Discarding the Meter, Test Strips, Lancing Devices, Lancets, and Batteries 305 16.5 List of Icons 307 16.6 Warranty and Limited License 316 16.7 Additional Supplies 320 16.8 Information for Healthcare Professionals 320 16.9 Meter Information 321 16.10 Error Log 322 16.11 Radio Frequency (RF) Signal 324 16.12 Meter Range Limits and Defaults 326 Appendix A: Bolus Advice Overview 331 Appendix B: Bolus Advice Calculations 343 Glossary 349 Index 357 52297_07167776001.indb 410/20/14 11:17 AM 1 1 1 Important Safety Information Please read this user’s manual carefully before you use your ACCU‑CHEK Aviva Insight Diabetes Manager (hereafter referred to as the meter). To use it correctly and dependably, you need to understand the meter’s operation, screen displays, and all individual features. The ACCU‑CHEK Aviva Insight meter is indicated as an aid in the treatment of insulin requiring diabetes. The ACCU‑CHEK Aviva Insight system consists of the ACCU‑CHEK Aviva Insight meter, ACCU‑CHEK Aviva Plus test strips, ACCU‑CHEK Aviva control solutions, and ACCU‑CHEK Bolus Advisor. The ACCU‑CHEK Aviva Insight meter is intended to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and are under the supervision of healthcare professionals experienced in managing insulin treated patients. 1.1 The ACCU‑CHEK Aviva Insight System 52297_07167776001.indb 110/20/14 11:17 AM 2 The ACCU‑CHEK Aviva Insight blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The ACCU‑CHEK Aviva Insight blood glucose monitoring system is intended for self‑testing outside the body (in vitro diagnostic use) by people with diabetes. The ACCU‑CHEK Aviva Insight blood glucose monitoring system is intended to be used by a single person and should not be shared. The ACCU‑CHEK Aviva Insight blood glucose monitoring system should not be used for the diagnosis or screening of diabetes or for n…

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12 8.10 Time Block Settings This section is for changing the settings for individual time blocks when bolus advice is turned off. These time block settings include: jStart time jEnd time jTarget range Main Menu > Settings > Time Blocks NOTE It is recommended that you discuss possible updates to your time block settings with your healthcare professional prior to making changes. From the Main Menu, select Settings. Select Time Blocks. 8 151 52297_07167776001.indb 15110/20/14 11:18 AM 3 Select a time block to edit. NOTE jThe End time of a time block is the same as the Start time of its following time block. Only an End time can be changed, which changes the Start time of the following time block. jChanging the End time of the last time block does not change the Start time of the first time block, but it creates a new time block. See the Adding a Time Block section in this chapter. jTo change the Start time of the first time block, the time blocks must be reset. See the Resetting All Time Blocks section in this chapter. jIf the End time of a time block is decreased until it is the same as its Start time, the time block is deleted. See the Deleting Time Blocks section in this chapter. NOTE Time Blocks cannot be selected if it is shaded. The shading means bolus advice is turned on. If Time Blocks is shaded, go to the Bolus Advice: Time Block Settings section in the Changing Bolus Advice Settings chapter in this user’s manual. 152 52297_07167776001.indb 15210/20/14 11:18 AM 4 Set the End time. Select Next. 6 Edit any other time block (reference Step 3). Once all time blocks are complete, select Done. 5 Set the Upper value and Lower value. Select Save. 8 153 52297_07167776001.indb 15310/20/14 11:18 AM 8.11 Adding a Time Block This section is for adding a time block if bolus advice is turned off. Before adding a time block, have the following information available: jThe number of time blocks you need with the start and end times for each jThe blood glucose target range for each time block To add a time block, decrease the last time block’s end time. After the time block is created, it may be necessary to change the start time, end time, and other information for each time block until all of the time blocks are set up the way you want them. NOTE It is recommended that you discuss possible updates to your time block settings with your healthcare professional prior to making changes. 154 52297_07167776001.indb 15410/20/14 11:18 AM 3 Select the last time block. NOTE Time Blocks cannot be selected if it is shaded. The shading means bolus advice is turned on. If Time Blocks is shaded, go to the Bolus Advice: Adding a Time Block section in the Changing Bolus Advice Settings chapter in this user’s manual. 2 Select Time Blocks. 1 From the Main Menu, select Settings. Main Menu > Settings > Time Blocks 8 155 52297_07167776001.indb 15510/20/14 11:18 AM 5 Select Next. 4 Decrease the End time. NOTE jDecrease the End time for the last time block by any amount in order to create a new time block. This creates a time block by splitting the last time block into 2 time blocks. jDo not decrease the End time until it equals the Start time because the meter deletes the time block when you select Next. jOnce the new time block is created, you can change the Start time and End time for all appropriate time blocks. jFor this example, a time block is added with a Start time of 9:30 pm and an End time of 11:00 pm. 156 52297_07167776001.indb 15610/20/14 11:18 AM 67 Set the Upper value and Lower value for the new time block. Select Save. It may be necessary to change the start times, end times, and settings of other time blocks. Select a time block to edit and continue to Step 8. If you do not need to make any changes, select Done and the addition of the time block is complete. NOTE jThe End time of a time block is the same as the Start time of its following time block. Only an End time can be changed, which changes the Start time of the following time block. jTo change the Start time of the first time block, the time blocks must be reset. See the Resetting All Time Blocks section in this chapter. jIf the End time of a time block is decreased until it is the same as its Start time, the time block is deleted. See the Deleting Time Blocks section in this chapter. 8 157 52297_07167776001.indb 15710/20/14 11:18 AM 810 Set the End time. Select Next. Edit any other time block (reference Step 7). Once all time blocks are complete, select Done. 9 Set the Upper value and Lower value. Select Save. 158 52297_07167776001.indb 15810/20/14 11:18 AM 8.12 Deleting Time Blocks This section is for deleting time blocks if bolus advice is turned off. There are 2 different methods for deleting time blocks. The first method deletes one or more time blocks by combining time blocks. The alternative method deletes a single time block. Before deleting time blocks, have the following information available: jThe number of time blocks you need with the start and end times for each jThe blood glucose target range for each time block After time blocks are deleted, it may be necessary to change the start times, end times, and other information for the remaining time blocks until all of the time blocks are set up the way you want them. NOTE It is recommended that you discuss possible updates to your time block settings with your healthcare professional prior to making changes. 8 159 52297_07167776001.indb 15910/20/14 11:18 AM 8.12.1 Deleting One or More Time Blocks This method of deleting one or more time blocks is accomplished by combining time blocks. Main Menu > Settings > Time Blocks 12 From the Main Menu, select Settings. Select Time Blocks. NOTE Time Blocks cannot be selected if it is shaded. The shading means bolus advice is turned on. If Time Blocks is shaded, go to the Bolus Advice: Deleting Time Blocks section in the Changing Bolus Advice Settings chapter in this user’s manual. 160 52297_07167776001.indb 16010/20/14 11:18 AM 3 Select the first tim…

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FCC ID: WX3-816 D.L.S. ELECTRONIC SYSTEMS, INC. 166 South Carter Street Genoa City, WI 53128 10/31/2014 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Gentlemen: We are submitting for Roche Diagnostics Operations, Inc. an Accu-Chek Aviva Insight blood glucose meter, Model Number: 465, with FCC ID: WX3-816 for Certification. This unit has been tested and complies to Part 15, Subpart C. If there are any questions in regard to this application, please call D.L.S. Electronic Systems, Inc. at (262) 279-0210. Enclosed you will find a copy of our test report with the information and results of tests that is required under Part 15, Section 15.247. Thank you for your assistance in this matter. Sincerely, William M. Stumpf DLS/js

166 South Carter Street, Genoa City, WI 53128 Request for Confidentiality Date: 10/31/2014 FCC Authorization & Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 RE: Certification Application FCC ID: WX3-816 Pursuant to 47 CFR Section 0.459 Roche Diagnostics Operations, Inc. understands that requests for nondisclosure and confidential treatment is being made for the following information as stated under the Code of Federal Regulations Chapter 47, Part 0.459: • Block Diagram • Schematics • Operational Description The above materials contain trade secrets, proprietary and technical information that would customarily be guarded from competitors under 47 CFR section 0.457(d)(2). Disclosure or publication of any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. Roche Diagnostics Operations, Inc. understands that pursuant to 47 CFR section 0.457(d)(1)(ii) disclosure of the applicant and all accompanying documentation will not be made before the date of the grant. Thank you for your attention to this matter. Signatory William M. Stumpf OATS Manager D.L.S. Electronic Systems, Inc.

External Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Front of Meter Back of Meter (with prototype label info) External Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Left Side of Meter Right Side of Meter Bottom of Meter

Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Opened Case - Inside Front Cover Opened Case - Inside Back Cover Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Bottom of Meter Bottom of Meter showing COMMS Board above Mother Board Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) COMMS Board on Mother Board - Top View Top View of Mother Board with Bottom View of COMMS Board Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Bottom View of COMMS Board - Close Up Bottom View of COMMS Board - Close Up, Shield Removed Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Top View of Mother Board - alone Bottom View of Mother Board Internal Photos Company: Roche Diagnostics Operations, Inc. Model: 481(482 in Canada) Mother Board - Side View 1 Mother Board - Side View 2

166 South Carter, Genoa City, WI 53128 Company: Roche Diagnostics Model Tested: 481 DLS Project: 5792 RF Exposure Compliance Company: Roche Diagnostics Operations, Inc. Model: Model 481 tested to represent Aviva Models 465, 481 & 482, and Performa Models 467 & 468 Formal Name: Accu-Chek Aviva Insight (tested) and Accu-Chek Performa Insight Rule Part: CFR 47 Part 1.1307(b) CFR 47 Part 2.1093 Test Procedure: FCC 447498 10 D01 General RF Exposure Guidance v05 4.3. General SAR test reduction and exclusion guidance 4.3.1. Standalone SAR test exclusion considerations Limits: The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)]· [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where: f(GHz) is the RF channel transmit frequency in GHz. Power and distance are rounded to the nearest mW and mm before calculation. The result is rounded to one decimal place for comparison. When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. Output Power: This is a portable device. The maximum peak power measured is 9.21 dBm conducted. The antenna gain is 3.8 dBi. 9.21 dBm = 8.3mW. Exclusion threshold: [8 mW / 5 mm] x [√2.480 GHz] = 2.5 Results: 2.5 is ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR. SAR measurement is not necessary.

166 South Carter, Genoa City, WI 53128 Page 1 of 63 Company: Roche Diagnostics Model Tested: 481 Report Number: 19041 DLS Project: 5792 i. Cover Page Code of Federal Regulations 47 Part 15 – Radio Frequency Devices Subpart C – Intentional Radiators Section 15.247 Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz, and 24.0 - 24.25 GHz. THE FOLLOWING MEETS THE ABOVE TEST SPECIFICATION Formal Name: Accu -Chek Aviva Insight (tested) and Accu-Chek Performa Insight Kind of Equipment: Bluetooth transceiver Frequency Range: 2402-2480 MHz Test Configuration: Hand -held Model Number(s): Model 481, 482, 465, 467 and 468 Model(s) Tested: 481 (labeled as "Calypso meter with Bluetooth" on test data) Serial Number(s): RF Conducted: 48100002115 Radiated: 48100001895 Date of Tests: April 2 nd through April 24 th , 2013 Test Conducted For: Roche Diagnostics Operations, Inc. 9115 Hague Road Indianapolis, IN 46256, USA NOTICE: “This test report relates only to the items tested and must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government”. Please see the "Description of Test Sample" page listed inside of this report. © Copyright 1983 - 2013 D.L.S. Electronic Systems, Inc. COPYRIGHT NOTICE This report must not be reproduced (except in full), without the approval of D.L.S. Electronic Systems, Inc. 166 South Carter, Genoa City, WI 53128 Page 2 of 63 Company: Roche Diagnostics Model Tested: 481 Report Number: 19041 DLS Project: 5792 ii. Signature Page SIGNATURE PAGE Tested By: Craig Brandt Test Engineer Reviewed By: William Stumpf OATS Manager Approved By: Brian Mattson General Manager 166 South Carter, Genoa City, WI 53128 Page 3 of 63 Company: Roche Diagnostics Model Tested: 481 Report Number: 19041 DLS Project: 5792 iii. Table of Contents Table of Contents i. Cover Page .......................................................................................................................................1 ii. Signature Page .................................................................................................................................2 iii. Table of Contents .............................................................................................................................3 iv. NVLAP Certificate of Accreditation ...............................................................................................4 1.0 Summary of Test Report ..................................................................................................................5 2.0 Introduction ......................................................................................................................................6 3.0 Test Facilities ...................................................................................................................................6 4.0 Description of Test Sample ..............................................................................................................6 5.0 Test Equipment ................................................................................................................................8 6.0 Test Arrangements ...........................................................................................................................9 7.0 Test Conditions ..............................................................................................................................10 8.0 Modifications Made To EUT For Compliance ..............................................................................10 9.0 Additional Descriptions .................................................................................................................10 10.0 Results ............................................................................................................................................10 11.0 Conclusion .....................................................................................................................................10 Appendix A – Test Photos .........................................................................................................................11 Appendix B – Measurement Data ..............................................................................................................16 1.0 20 dB Bandwidth .................................................................................................................16 2.0 Carrier Frequency Separation ..............................................................................................20 3.0 Number of Hopping Channels .............................................................................................22 4.0 Time of Occupancy ..............................................................................................................25 5.0 Maximum Peak Conducted Output Power ..........................................................................28 6.0 Spurious RF Conducted Emissions ......................................................................................32 7.0 Band -Edge Compliance - RF Conducted .............................................................................45 8.0 Duty Cycle Correction Factor ..............................................................................................50 9.0 Unwanted Emissions into Restricted Frequency Bands – Radiated ....................................51 10.0 Band -Edge Measurements – Radiated Upper Restricted Band ...........................................55 11.0 AC Line Conducted Emissions ............................................................................................58 166 South Carter, Genoa City, WI 53128 Page 4 of 63 Company: Roche Diagnostics Model Tested: 481 Report Number: 19041 DLS Project: 5792 iv. NVLAP Certificate of Accreditation 166 South Carter, Genoa City, WI 53128 Page 5 of 63 Company: Roche Diagnostics Model Tested: 481 Report Number: 19041 DLS Projec…

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166 South Carter, Genoa City, WI 53128 Page 1 of 5 Manufacturer: Roche Diagnostics Model Tested: 481 Project Number: 5792 Photo Information and Test Setup: Item 0: Roche Diagnostics Accu-Chek Aviva Insight model 481 (Model 465 in the U SA; Model 482 in Cana da . See page 6 of t he t est r eport f or t he expl ana tion for t he model numbe r differenc es.) Item 1: AC Power adapter. Phihong model PSM03A-050Q. Item 2: 1 meter shielded USB cable. Radiated Emissions - above 1 GHz 166 South Carter, Genoa City, WI 53128 Page 2 of 5 Manufacturer: Roche Diagnostics Model Tested: 481 Project Number: 5792 Test Setup Photos Radiated Emissions - above 1 GHz - position 1 Radiated Emissions - above 1 GHz - position 2 166 South Carter, Genoa City, WI 53128 Page 3 of 5 Manufacturer: Roche Diagnostics Model Tested: 481 Project Number: 5792 Test Setup Photos Radiated Emissions - above 1 GHz - position 3 Radiated Emissions - below 1 GHz - front 166 South Carter, Genoa City, WI 53128 Page 4 of 5 Manufacturer: Roche Diagnostics Model Tested: 481 Project Number: 5792 Test Setup Photos Radiated Emissions - below 1 GHz - back RF conducted 166 South Carter, Genoa City, WI 53128 Page 5 of 5 Manufacturer: Roche Diagnostics Model Tested: 481 Project Number: 5792 Test Setup Photos AC Line Conducted Emissions