I5QMBlood Glucose meter with Bluetooth Sync.

1 Owner’s Booklet Blood Glucose Monitoring System Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 16/23/11 4:51 PM 2 Owner’s Booklet Thanks for choosing OneTouch®! The OneTouch® Verio™ Sync™ Blood Glucose Monitoring System is one of the latest product innovations from LifeScan. The Bluetooth® (wireless RF) communication feature lets the meter send blood glucose test results to the OneTouch® Verio™ Reveal™ Application* on your compatible** Apple® device. The App will let you review and graph your results, and help identify patterns. This Owner’s Booklet offers a complete explanation of how to use your new meter and testing supplies, and reviews the do’s and don’ts of testing your blood glucose. Clear instructions and visuals will help you get comfortable using the OneTouch® Verio™ Sync™ Meter, so you can expect to get reliable results every time you test. Please keep your Owner’s Booklet in a safe place; you may want to refer to it in the future. We hope OneTouch® products and services will continue to be a part of your life. *Throughout this booklet, OneTouch® Verio™ Reveal™ Application will be referred to as the “App.” For details on the App, please see the App Owner's Booklet or More > Help in the App. **Apple® devices include the iPhone®, iPad®, and iPod® touch devices using iOS4+. Throughout this booklet, the iPhone®, iPad®, and iPod® touch will be referred to as “Apple® devices.” Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 26/23/11 4:51 PM 3 Symbols Cautions and Warnings. Refer to the Owner’s Booklet and inserts that came with your system for safety-related information. Direct current Consult instructions for use Low battery Empty battery Low battery charging Empty battery charging Last blood glucose result Apply blood Do not apply blood/Do not test Bluetooth® (wireless RF activated) Airplane mode (wireless RF not activated) Synchronization with the OneTouch® Verio™ Sync™ App Control solution test result Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 36/23/11 4:51 PM 4 Table of Contents 1 Setting up your system - Turning your meter on 16 - Turning your meter off 17 - Pairing your meter with an Apple® device 18 - Syncing your meter with the App 23 2 Taking a test - Testing your blood glucose 28 - Testing with control solution 51 3 Viewing your results 60 4 Care and maintenance 62 5 Battery (recharging) 68 6 Troubleshooting 76 7 Detailed information about your system 92 8 Index 102 T Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 46/23/11 4:51 PM 5 Before you begin Before using this product to test your blood glucose, carefully read this Owner’s Booklet, and the inserts that come with the OneTouch® Verio™ Test Strips and OneTouch® Verio™ Control Solutions. NOTE: It is best to fully charge the battery before using the OneTouch® Verio™ Sync™ Meter. See pages 68-75 for instructions. Apple® Legal Notice “Made for iPod®,” “Made for iPhone®,” and “Made for iPad®” mean that an electronic accessory has been designed to connect specifically to iPod®, iPhone®, or iPad®, respectively, and has been certified by the developer to meet Apple® performance standards. Apple® is not responsible for the operation of this device or its compliance with safety and regulatory standards. Please note that the use of this accessory with iPod®, iPhone®, or iPad® may affect wireless performance. Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 56/23/11 4:51 PM 6 Important safety instructions đƫƫ$%/ƫ)!0!.ƫ* ƫ(*%*#ƫ !2%!ƫ.!ƫ%*0!* ! ƫ0+ƫ!ƫ1/! ƫ by a single person and should not be shared, even with a family member. đƫƫ
"0!.ƫ1/!ƫ* ƫ!4,+/1.!ƫ0+ƫ(++ Čƫ((ƫ,.0/ƫ+"ƫ0$%/ƫ kit are considered biohazardous. A used kit can potentially transmit infectious diseases even after you have performed cleaning and disinfection. For more information, see: FDA Public Health Notification: “Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/ucm224025.htm. 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. Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm margin AW05947201A_OT Verio Sync_OB_Insides_R3.indd 66/23/11 4:51 PM 7 Intended use The OneTouch® Verio™ Sync™ Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single person and should not be shared. The OneTouch® Verio™ Sync™ BGMS is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio™ Sync™ BGMS is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Not for critically ill patients, patients in shock, dehydrated patients or hyperosmolar patients. The OneTouch® Verio™ Sync™ Meter is intended for use with the OneTouch® Verio™ Control Solutions and OneTouch® Verio™ Test Strips. The OneTouch® Verio™ Control Solution is used to check that the meter and test strips are working together properly and that the test is performed correctly. The OneTouch® Verio™ Sync™ BGMS communicates wirelessly with both the OneTouch® application on commercially available mobile devices and via USB cable with LifeScan diabetes PC-based applications. Yellow = 5mm margin, Red = 7mm margin Yellow = 5mm margin, Red = 7mm mar…

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Test Report No.: G0M21102-4189-P-15 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Annex A Photos EUT FRONT EUT BACK Page 32 of 119 Test Report No.: G0M21102-4189-P-15 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT SIDE VIEW PCB FRONT Page 33 of 119

___________________________________________________________________________________________________________ Rev.01 author: UK MANGO ---- 06_[model LabelSmpl (DRAFT).doc 29-Aug-11 1/1 DRAFT label for “Mango” The RED areas may change

___________________________________________________________________________________________________________ Rev.01 author: UK MANGO ---- 07_[model] LabelLoc.doc 29-Aug-11 1/1 label position for “Mango” 27.8mm 41.7mm 27.7mm 6.9mm

Test Report No.: G0M21102-4189-P-15 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT SIDE VIEW PCB FRONT Page 33 of 119 Test Report No.: G0M21102-4189-P-15 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany PCB BACK PCB MODULE WITHOUT SHIELD Page 34 of 119

Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 EUROFINS PRODUCT SERVICE GMBH RF-EXPOSURE A SSESSMENT FCC 47 CFR 2.1093 IC RSS-102 Blood glucose meter Mango FCC ID: I5QM REPORT NUMBER: G0M21102-4189-C-4 Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 2 of 11 TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Testing laboratory 4 1.3 Details of approval holder 5 1.4 Application details 5 1.5 Acronyms and abbreviations 5 1.6 Reference standards 6 1.7 Test item 7 1.8 Referenced documents 7 1.9 Additional information 7 2 Exposure Assessment 8 2.1 Device Types 8 2.2 Exposure Categories 8 2.3 SAR Limits 9 2.4 SAR Evaluation exemptions 10 2.5 Exposure assessment 11 Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 11 1.2 Testing laboratory EUROFINS PRODUCT SERVICE GMBH Storkower Strasse 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 660 DA KKS ACCREDITED TESTING LABORATORY DA KKS-REGISTRATION NUMBER: D-PL-12092-01-01 R ECOGNIZED NOTIFIED BODY EMC R EGISTRATION NUMBER: BNetzA-bS EMV-07/61 R ECOGNIZED NOTIFIED BODY R&TTE R EGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY R EG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY C ERTIFICATE NO. 1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY R EG. NO. IC 3470 Test location, where different: Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 11 1.3 Details of approval holder Name : LifeScan Inc. Street : 1000 Gibraltar Drive Town : CA 95035 Milpitas Country : USA Telephone : +1 407 942 3868 Fax : +1 408 942 5600 Contact : Mr. Sharbel Noujaim Telephone : +1 407 942 3868 Manufacturer: (if applicable) Name : LifeScan Inc. Street : 1000 Gibraltar Drive Town : CA 95035 Milpitas Country : USA 1.4 Application details Date of receipt of application : 15.03.2011 Date of receipt of test item : 15.03.2011 Date of assessment : 30.08.2011 1.5 Acronyms and abbreviations EUT : Equipment under Test TX : Transmission RX : Reception RBW : Measurement Resolution Bandwidth Pol : Measurement Polarization N/A : Not applicable Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 11 1.6 Reference standards Technical standards : FCC 47 CFR 1.1310 FCC 47 CFR 2.1091 FCC 47 CFR 2.1093 OET Bulletin 65 Supplement C : ” Evaluating Compliance with FCC Guidelines for Human Exposure to Radiofre- quency Electromagnetic Fields” 2001 RSS-102 Issue 4 : “Radio Frequency (RF) Exposure Com pliance of Radiocommunication Apparatus (All Frequency Bands)”, 2010 Safety Code 6: “Limits of Human Exposure to Radiofre quency Electromagnetic Energy in the Frequency Range from 3 kHz to 300 GHz”, 2009 IEEE C95.3 : “IEEE Recommended Practice for Measure ments and Computations of Radio Frequency Electro magnetic Fields With Respect to Human Exposure to Such Fields, 100 kHz–300 GHz”, 2002 Health Canada : “Technical Guide for Interpretation and Compliance Assessment of Health Canada’s Radiofre quency Exposure Guidelines”, 2009 KDB 447498 “Mobile and Portable Device RF Exposure Procedures and Equipment Authorization Policies”, 2009 Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 11 1.7 Test item Description of test item : Blood glucose meter Type identification : Mango Serial Number : None Hardware version : DV3 Software version : 01.00.00 Radiation sources included : Bluetooth Equipment type : End product Exposure Category : Uncontrolled / General public Device type : Portable 1.8 Referenced documents FCC/IC Bluetooth test report : G0M21102-4189-P-15 Eurofins Product Service GmbH 1.9 Additional information None Test Report No.: G0M21102-4189-C-4 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 11 2 Exposure Assessment 2.1 Device Types Fixed A fixed device is defined as a device physically secured at one fixed location and cannot be easily re- located. Mobile A mobile device is defined as a transmitting device designed to be used in other than fixed locations and to generally be used in such a way that a separation distance of at least 20 centimeters is nor- mally maintained between the transmitter's radiating structure(s) and the body of the user or nearby persons. (47 CFR 2.1091) Portable A portable device is defined as a transmitting device designed to be used so that the radiating struc- ture(s) of the device is/are within 20 centimeters of the body of the user. (47 CFR 2.1093) 2.2 Exposure Categories Occupational / Controlled Exposure In general, occupational/controlled exposure limits are applicable to situations in which persons are exposed as a consequence of their employment, who have been made fully aware of the potential for exposure and can exercise control over their exposure. This exposure category is also applicable when the exposure is of a transient nature due to incidental passage through a location where the exposure levels may be higher than the general population/uncontrolled limits, but the exposed person is fully aware of the potential for exposure and can exercise control over his or her exposure by leav- ing the area or by some other appropriate means. Awareness of the potential for RF exposure in a workplace or similar environment can be provided through specific training as part of a RF safety pro- gram. If appropriate, warning signs and labels can also be used to establish such awareness by pro- viding prominent information on the risk of potential exposure and instructi…

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Test Report issued under the responsibility of: Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 19 EMC TEST REPORT FCC 47 CFR Part 15B Industry Canada RSS-Gen Electromagnetic compatibility - Unintentional radiators Report Reference No. .................... : G0M21102-4189 – C-3 Testing Laboratory ........................ : Eurofins Product Service GmbH Address ............................................ : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation .................................... : FCC Filed Test Laboratory, Reg.-No.: 96970 A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 Applicant’s name ........................... : LifeScan Inc. Address ............................................ : 1000 Gibraltar Drive CA 95035 Milpitas USA Test specification: Standard ........................................... : 47 CFR Part 15 Subpart B RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 Equipment under test (EUT): Product description Blood glucose meter Model No. Mango Hardware version DV3 Firmware / Software version 01.00.00 FCC-ID: I5QM IC: N/A Test result Passed Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 19 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION: 4 1.1 Equipment photos 5 1.2 Supporting Equipment Used During Testing: 6 1.3 Operating Modes: 7 1.4 Test Equipment Used During Testing 8 2 RESULT SUMMARY 9 3 TEST CONDITIONS AND RESULTS 10 3.1 Test Conditions and Results – Radiated emissions 10 3.2 Test Conditions and Results – AC power line conducted emissions 16 Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 19 1 Equipment (Test item) Description: Description Blood glucose meter Model Mango Serial number V4CNS05C Hardware version DV3 Software / Firmware version 01.00.00 Power supply 3.7VDC AC/DC-Adaptor None Highest emission frequency 1.705MHz - 108MHz (up to 1GHz) Device classification Class B Equipment type Tabletop Number of tested samples 1 Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 19 1.2 Supporting Equipment Used During Testing: Product Type* Device Manufacturer Model No. Comments AE Laptop Lenovo T400 AE AC/DC Adapter Lenovo P/N: 92P1107 *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 7 of 19 1.3 Operating Modes: Mode # Description 1 measurement mode active and data transmission USB mode to laptop Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 8 of 19 1.4 Test Equipment Used During Testing Radiated emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Biconical Antenna R&S HK 116 Inv. No. 0012 Jan 10 Jan 13 LPD-Antenne R&S HL 223 Inv. No. 0295 Feb 11 Feb 13 LPD-Antenna R&S HL 025 Inv. No. 0512 Feb 10 Feb 13 EMI Test Receiver R&S ESU8 Inv. No. 0567 Dec 10 Dec 11 EMI Test Receiver R&S ESCS30 Inv. No. 0474 Jun 11 Jun 12 Conducted emissions Description Manufacturer Model Identifier Cal. Date Cal. Due AMN R&S ESH2-Z5 Inv. No. 0288 Sep 10 Sep 12 AMN R&S ESH3-Z5 Inv. No. 0040 Nov 10 Nov 12 EMI Test Receiver R&S ESCS 30 Inv. No. 0474 Jun 11 Jun 12 Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 19 2 Result Summary FCC 47 CFR Part 15B, Industry Canada RSS-Gen Product Specific Standard Requirement – Test Reference Method Result Remarks 47 CFR 15.109 RSS-Gen 4.9 & 4.10 Radiated emissions ANSI C 63.4 PASS 47 CFR 15.107 RSS-Gen 7.2.4 AC power line conducted emissions ANSI C63.4 PASS Remarks: Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 19 3 Test Conditions and Results 3.1 Test Conditions and Results – Radiated emissions Radiated emissions acc. FCC 47 CFR 15.109 / IC RSS-Gen Verdict: PASS Laboratory Parameters: Required prior to the test During the test Ambient Temperature 15 to 35°C 22°C Relative Humidity 30 to 60% 44% Test according referenced standards Reference Method ANSI C63.4 Sample is tested with respect to the requirements of the equipment class Equipment class Class B Test frequency range determined from highest emission frequency Highest emission frequency 1.705MHz - 108MHz (up to 1GHz) Fully configured sample scanned over the following frequency range Frequency range 30MHz to 1GHz Limits and results Class B Frequency [MHz] Quasi-Peak [dBμV/m] Result Average [dBμV/m] Result 30 – 88 40 PASS - - 88 – 216 43.5 PASS - - 216 – 960 46 PASS - - 960 – 1000 54 PASS - - > 1000 - - 54 PASS Comments: Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 19 Test setup Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 19 Spurious emissions under normal conditions according to FCC Part 15b Order number: G0M21102-4189 Manufacturer: LifeScan California EUT Name: Blood glucose handheld meter (Mango) Model: V3CHN06B Test Site: Eurofins Product Service GmbH Operator: Mr. Marquardt Test Conditions: Tnom: 23°C, Unom: 3.7 VDC Lithium Antenna: Rohde & Schwarz HK 116, Vertical Measurement distance: 3m Mode: USB-link, measure Test Date: 17.08.2011 Note: Index 25 0 5 10 15 20 25 30 35 40 45 50 55 60 40 M60 M80 M100 M120 M140 M160 M200 M30 M Frequency (Hz) Electrical Field (dBμV/m) FCC part 15B Class B QPRBW: 120 kHz, Vertical Max Peak Test Report No.: G0M21102-4189-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 13 of 19 Spurious emiss…

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Test Report No.: G0M21102-4189-P-15 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TESTSETUP RADIATED MEASUREMENTS TESTSETUP CONDUCTED MEASUREMENTS Page 35 of 119