VN5-N2Contour Next Link Blood Glucose Meter

LINK WIRELESS BLOOD GLUCOSE MONITORING SYSTEM USES BAYER’S CONTOUR ® OR CONTOUR ® NEXT BLOOD GLUCOSE TEST STRIPS www.bayerdiabetes.com/us USER GUIDE 18211 NE 68th Street, E120 Redmond, WA 98052 T425-881-5454 Contour Next LINK User Guide Master English Alt#1 - 2/15/11 - copy/image changes Alt#2 - 2/17/11 - Copy changes Alt#3 - 3/08/11 - Copy/image changes Alt#3-1 - 3/09/11 - Copy/image changes Alt#3-2 - 3/09/11 - Copy/image changes Alt#3-3 - 3/09/11 - Copy changes Alt#4 - 3/15/11 - Copy changes Alt#5 - 3/18/11 - Copy changes Alt# 6 - 5/18/11 Copy changes DATE: CLIENT: DESCRIPTION: SCHAWK JOB#: BAN#: SKU#: DIMENSIONS: PRINTER SPEC: V-6 ENGLISH PROCESS CYAN PROCESS MAGENTA PROCESS YELLOW PROCESS BLACK COLORS Helvetica, Times, Arial, Berthold Akzidenz Grotesk, Skinny Mini, Frutiger, Zapf Dingbats, MiniMicra FONTS May 18, 2011 Bayer HealthCare Contour Next LINK User Guide Master English 905844 XXXXXXXX Rev. 02/11 N/A 6.0" (H) x 4.5" (W) PUSG0494 REV F MST_CntrNextLINK_UG_EN_FpBp_v6.indd ofc1MST_CntrNextLINK_UG_EN_FpBp_v6.indd ofc15/18/11 2:54 PM5/18/11 2:54 PM INTENDED USE: The CONTOUR ® NEXT LINK wireless blood glucose monitoring system is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single- patient use only. The C ONTOUR NEXT LINK blood glucose monitoring system is indicated for use with fresh capillary whole blood samples drawn from the fi ngertip and palm only. The C ONTOUR NEXT LINK wireless blood glucose monitoring system may be used to transmit glucose values to compatible Medtronic Minimed devices and facilitate transfer of information to Medtronic’s CareLink ® Therapy Management software through use of radio frequency communication. The C ONTOUR NEXT LINK wireless blood glucose monitoring system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. TABLE OF CONTENTS Your Meter Features 2 Talking to Your Compatible Medtronic MiniMed Device 3 Bayer’s CONTOUR NEXT LINK Blood Glucose Monitoring System 4 Meter Overview 6 Initial Setup 8 AutoLog Feature 10 Information for Safety 12 Getting Ready to Test 14 Getting the Blood Drop 17 Fingertip Testing 17 Alternative Site Testing (Palm) 21 Cleaning and Disinfecting 29 High and Low Blood Sugar Alert Screens 33 High and Low Blood Sugar Readings 34 Control Solution Testing 35 Menu Button/Logbook (Viewing Stored Results) 46 Trends 47 Setup: Pump Options 49 Date, Time and Sound 51 AutoLog On/Off 55 Target Range 56 Language 59 Transferring Data to Medtronic’s CareLink Personal Therapy Management Software 60 Setting a Reminder 38 Turning Off a Reminder 42 Getting a Reminder 44 Adding Notes 45 Error Detection and Battery Status/Charging/Removal 62 Symptoms of High and Low Blood Sugar 67 System Performance Information 68 Service Information 73 Symbols Used 74 System Specifi cations 74 Caring for Your Meter 76 Supplies/References/Warranty 76 Information for Safety WARNING: • The meter and lancing device are for single patient use. Do not share them with anyone including other family members! Do not use on multiple patients! 1,2 • All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. For complete instructions on cleaning and disinfecting your meter and lancing device, please see page 29. Important: Examine product for missing, damaged, or broken parts. Contact Bayer Diabetes Care Customer Service at 1-800-348-8100 for replacement parts. Read your CONTOUR NEXT LINK user guide, the MICROLET ® 2 lancing device insert and all instructional materials provided in your meter kit before testing. Please follow all instructions for use and care exactly as described to help avoid inaccurate results. Wash and dry your hands well before testing. Used test strips and lancets are possible biohazards and must be disposed of as medical waste. Main Menu Functions Technical, Service & Care Reminders and Notes Testing GettingStarted MST_CntrNextLINK_UG_EN_FpBp_v6.indd ifc2-1MST_CntrNextLINK_UG_EN_FpBp_v6.indd ifc2-15/18/11 3:01 PM5/18/11 3:01 PM 3 www.bayerdiabetes.com/us GettingStarted Talking to Your Compatible Medtronic MiniMed Device “Talks” to Your Compatible Medtronic MiniMed Device Bayer’s CONTOUR NEXT LINK meter can automatically send your blood glucose result directly to your compatible Medtronic MiniMed device. This eliminates the need to manually enter your blood glucose result into the insulin pump’s Bolus Wizard ® calculator, that calculates and suggests a bolus or correction dose if needed. Bayer’s CONTOUR NEXT LINK meter can also transmit your fi ngertip blood glucose result directly to your compatible Guardian REAL-Time CGM System, eliminating the need to manually enter the result when calibrating the system. See page 8 for initial setup options. Your compatible Medtronic MiniMed device will only accept the glucose result if the Meter Option in your device’s Utility Menu is set to on and you have programmed the device with the meter’s ID (serial) number. Up to three different meter ID numbers can be accepted. See page 8 in “Initial Setup”. If you have entered your meter’s ID number into your compatible Medtronic MiniMed device, it can receive your blood glucose result. No one else’s insulin pump or continuous glucose monitoring system can receive your glucose result, unless your meter ID number has been entered into that device. The meter uses a wireless signal to send the blood glucose result to the compatible Medtronic MiniMed device when the Send option is set to Always or Ask. See page 9 of this user guide. Your CONTOUR NEXT LINK meter and compatible Medtronic MiniMed device must be within 4 feet of each other. If you are not using the meter link feature on your compatible Medtronic MiniMed device, you may want to turn the Send option off on your CONTOUR NEXT LINK meter and Medtronic MiniMed device t…

Text truncated - open the document above for the full version.

EXTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC # VN5‐N2‐2 Page 1 of 2 Front side Side view EXTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC # VN5‐N2‐2 Page 2 of 2 Side view #2 Back side

1/6th of PDP Height(11.5mm) = 1.91mm Cross Size is 2.677 mm New File - Contour NEXT LINK Meter Back Label ALT#1 - 02.09.11 - Logo/Copy Change ALT#2 - 02.11.11 - Logo/Copy Change ALT#3 - 03.02.11 - Logo/Copy Change DATE: CLIENT: DESCRIPTION: SCHAWK JOB#: BAN #s: SKU #: BAYER SPEC: 2D CODE: March 02, 2011 Bayer HealthCare Contour NEXT LINK Meter Back Label - EN 946726A04 (Parent #) 83623013 (Material #) 83480093 Rev. 1/11 XXXX 10000006690 Rev.08 83480093 14x14 LANGUAGE(S):ENGLISH V-3 Helvetica Bold Myriad Pro Semibold Myriad Pro Berthold Akzidenz Grotesk BE Bold Berthold Akzidenz Grotesk BE Regular Berthold Akzidenz Grotesk BE Medium EN Market: US 200% READ ONLY 83623013 83480093 R1/11 Made in Japan Uses Bayer’s CONTOUR ® & C ONTOUR ® NEXT test strips. 800-348-8100 Distributed by: Bayer HealthCare LLC Mishawaka, IN 46544 BLOOD GLUCOSE METER FCC ID:VN5-N2 ® NEXT LINK Operating power 4.2V, 350mAh Charging power 5.0V, 500mAh mg/dL PS XXXX

INTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC ID # VN5‐N2 Page 1 of 5 EUT with back cove removed INTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC ID # VN5‐N2 Page 2 of 5 INTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC ID # VN5‐N2 Page 3 of 5 Front side of board with screen on INTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC ID # VN5‐N2 Page 4 of 5 INTERNAL PHOTOS Company Name Bayer Healthcare Diabetes Care Model # 6200 FCC ID # VN5‐N2 Page 5 of 5

W66 N220 Commerce Court ● Cedarburg, WI 53012 ● USA Phone: 262.375.4400 ● Fax: 262.375.4248 www.lsr.com TEST REPORT # 311043 LSR Job #: C-1117 Compliance Testing of: Bayer Healthcare’s Contour ® Next Link Blood Glucose Meter (Ninja 2) Test Date(s): February 28 th to March 3 rd 2011 Prepared For: Bayer Healthcare, LLC. Diabetes Care, 430 South Beiger Street Mishawaka, IN 46544 In accordance with: Federal Communications Commission (FCC) Part 15, Subpart C, Section 15.249 Industry Canada (IC) RSS 210 Annex 2 Transmitters Operating in the Frequency Band 902 MHz – 928 MHz This Test Report is issued under the Authority of: Khairul Aidi Zainal, Senior EMC Engineer Signature: Date:3.14.2011 Test Report Reviewed by: Peter Feilen, EMC Engineer Signature: Date: 3.14.2011 Tested by: Khairul Aidi Zainal, Senior EMC Engineer Signature: Date:3.14.2011 This Test Report may not be reproduced, except in full, without written approval of LS Research, LLC. Prepared For: Bayer Healthcare EUT: Contour Next Link LS Research, LLC Report # 311043 Model #:6200 Template: 15.249 8-11-2010 LSR Job #: C-1117 Serial #: SN P00001A SN P0000E0 Page 2 of 34 TABLE OF CONTENTS (page 1 of 2) EXHIBIT 1: INTRODUCTION 1.1 Scope 4 1.2 Normative References 4 1.3 LS Research, LLC Test Facility 5 1.4 Location of Testing 5 1.5 Test Equipment Utilized 5 EXHIBIT 2: PERFORMANCE ASSESSMENT 2.1 Client Information 6 2.2 Equipment Under Test (EUT) Information 6 2.3 Associated Antenna Description 6 2.4 EUT’s Technical Specifications 7 2.5 Product Description 8 EXHIBIT 3: EUT OPERATING CONDITIONS & CONFIGURATIONS DURING TESTS 3.1 Climate Test Conditions 8 3.2 Applicability & Summary of EMC Emission Test Results 8 3.3 Modifications Incorporated in the EUT for Compliance Purposes 8 3.4 Deviations & Exclusions from Test Specifications 8 EXHIBIT 4: DECLARATION OF CONFORMITY 9 EXHIBIT 5: RADIATED EMISSIONS TESTING 5.1 Test Setup 10 5.2 Test Procedure 10 5.3 Test Equipment Utilized 11 5.4 Test Results 11 5.5 Calculation of Radiated Emissions Limits 12 5.6 Radiated Emissions Test Data Chart 14 5.7 Test Setup Photo(s) – Radiated Emissions Test 16 5.8 Screen Captures – Radiated Emissions Test 18 EXHIBIT 6: CONDUCTED EMISSIONS TEST, AC POWER LINE 6.1 Test Setup 21 6.2 Test Procedure 21 6.3 Test Equipment Utilized 21 6.4 Test Results 21 6.5 FCC Limits of Conducted Emissions at the AC Mains Ports 22 6.6 Conducted Emissions Test Data Chart 23 6.7 Test Setup Photo(s) – Conducted Emissions Test 24 6.8 Screen Captures – Conducted Emissions Test 25 Prepared For: Bayer Healthcare EUT: Contour Next Link LS Research, LLC Report # 311043 Model #:6200 Template: 15.249 8-11-2010 LSR Job #: C-1117 Serial #: SN P00001A SN P0000E0 Page 3 of 34 TABLE OF CONTENTS (Page 2 of 2) EXHIBIT 7: OCCUPIED BANDWIDTH 7.1 Limits 26 7.2 Method of Measurements 26 7.3 Test Data 26 7.4 Screen Captures – Occupied Bandwidth 26 EXHIBIT 8: BAND-EDGE MEASUREMENTS 8.1 Method of Measurements 27 EXHIBIT 9: FREQUENCY & POWER STABILITY OVER VOLTAGE VARIATIONS 28 EXHIBIT 10: MPE CALCULATIONS 29 APPENDICES APPENDIX A: TEST EQUIPMENT LIST 30 APPENDIX B: TEST STANDARDS – RADIO 32 APPENDIX C: UNCERTAINTY STATEMENT 33 APPENDIX D: EUT PROGRAMMING INSTRUCTIONS. 34 Prepared For: Bayer Healthcare EUT: Contour Next Link LS Research, LLC Report # 311043 Model #:6200 Template: 15.249 8-11-2010 LSR Job #: C-1117 Serial #: SN P00001A SN P0000E0 Page 4 of 34 EXHIBIT 1. INTRODUCTION 1.1 SCOPE References: FCC Part 15, Subpart C, Section 15.249 and 15.209 FCC Part 2, Section 2.1043 paragraph (b)1. RSS GEN and RSS 210 Annex 2 Title: FCC : Telecommunication – Code of Federal Regulations, CFR 47, Part 15. IC : Low-power License-exempt Radio-communication Devices (All Frequency Bands): Category I Equipment Purpose of Test: To gain FCC and IC Certification Authorization for Low- Power License-Exempt Transmitters. Test Procedures: Both conducted and radiated emissions measurements were conducted in accordance with American National Standards Institute ANSI C63.4 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. Environmental Classification:  Commercial, Industrial or Business  Residential 1.2 NORMATIVE REFERENCES Publication Title 47 CFR, Parts 0-15 (FCC) Code of Federal Regulations - Telecommunications RSS 210 Low-power License-exempt Radio-communication Devices (All Frequency Bands): Category I Equipment ANSI C63.4 American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. CISPR 16-1-1 Specification for radio disturbance and immunity measuring apparatus and methods. Part 1-1: Measuring Apparatus. CISPR 16-2-1 Specification for radio disturbance and immunity measuring apparatus and methods. Part 201: Conducted disturbance measurement. Prepared For: Bayer Healthcare EUT: Contour Next Link LS Research, LLC Report # 311043 Model #:6200 Template: 15.249 8-11-2010 LSR Job #: C-1117 Serial #: SN P00001A SN P0000E0 Page 5 of 34 1.3 LS Research, LLC TEST FACILITY LS Research, LLC is accredited by A2LA (American Association for Laboratory Accreditation) to conform to ISO/IEC 17025, 2005 “General Requirements for the Competence of Calibration and Testing Laboratories”. LS Research, LLC’s scope of accreditation includes all test methods listed herein, unless otherwise noted. Accreditation status can be verified at A2LA’s web site: www.a2la2.net . 1.4 LOCATION OF TESTING All testing was performed at LS Research, LLC, W66 N220 Commerce Court, Cedarburg, Wisconsin, 53012 USA, utilizing the facilities listed below, unless otherwise noted. List of Facilities Located at LS Research, LLC:  Compact Chamber  Semi-Anechoic Chamber  Open Area Test Site (OATS) 1.5 TEST EQUIPMENT UTILIZED A complete list of equipment utilized in testing is provided in Appendix A of this test report. Calibration dates are indicated in …

Text truncated - open the document above for the full version.

Test Setup Photos Company: Bayer Healthcare Diabetes Care FCC ID: VN5-N2 Page 1 of 5 Photos Taken During Radiated Emission Testing Test Setup Photos Company: Bayer Healthcare Diabetes Care FCC ID: VN5-N2 Page 2 of 5 Photos Taken During Radiated Emission Testing (continued) Test Setup Photos Company: Bayer Healthcare Diabetes Care FCC ID: VN5-N2 Page 3 of 5 Photos Taken During Conducted Emissions Testing Test Setup Photos Company: Bayer Healthcare Diabetes Care FCC ID: VN5-N2 Page 4 of 5 Photos Taken During Testin g Test Setup Photos Company: Bayer Healthcare Diabetes Care FCC ID: VN5-N2 Page 5 of 5