DFW-02Wireless Activity Monitor

Objective Physical Activity and Sleep/Wake Monitoring Solutions actigraphcorp.com Health research Clinical trials Epidemiological studies Chronic disease management Sleep research Clinical sleep medicine Corporate wellness Sports medicine Innovative objective monitoring solutions ActiGraph is a leading provider of objective physical activity and sleep/wake monitoring solutions for the global research community. Our innovative and extensively validated accelerometry hardware and software system delivers accurate, measurable insight into the real world physiological behaviors of subjects involved in a variety of research and clinical projects. Validated technology delivers data you can trust ActiGraph is widely regarded as the “Gold Standard” in objective ambulatory measurement technology. Backed by more than a decade of independent scientific validation, ActiGraph solutions have been used in hundreds of complex, large scale, multi-site research studies around the world to capture and deliver accurate and reliable objective physical activity and sleep/wake data. Our trusted measurement technology is supported by a variety of advance wireless mobile and cloud communication tools to increase project flexibility and accommodate a wide range of study designs and protocol requirements. Customizable solutions, seamless implementation ActiGraph hardware devices are supported by an adaptable suite of technology solutions designed to meet the specific needs and complexities of your project. Our powerful ActiLife software, suite of mobile apps, Study Admin web portal, and API can be custom configured to achieve your data collection objectives while streamlining workflow and helping to ensure that studies are completed on time and on budget. ActiGraph monitoring solutions can be easily implemented within your research project or clinical trial to deliver high quality objective physiological measures, thereby improving the integrity of your study data and eliminating issues associated with subjective data collection methods and unreliable measurement tools. The ‘Gold Standard’ in physical activity measurement ActiGraph’s ambulatory monitoring devices have been used for more than a decade in thousands of human research projects and hundreds of large scale population studies involving physical activity, energy expenditure and their relationships to chronic health conditions such as obesity, diabetes, cardiovascular disease, cancer, and sleep disorders. Advantages Most scientifically validated objective activity monitoring technology available. Powerful research-driven software platform delivers advanced, highly customizable metrics. Innovative mobile and web-based tools accommodate a broad range of study designs and interventional protocols. Widespread global implementation guarantees data comparability with thousands of published studies. Optimize trial data quality, safety and cost effectiveness Objective information about real world patient behavior is a valuable resource to researchers and physicians involved in phase I-IV clinical trials. Endpoints related to subjects’ daily activity and sleep behaviors provide vital, measurable insight into the therapeutic value of an investigational treatment and may help identify possible adverse events during intervention. Advantages Continuous objective physiological measures augment patient reported outcome data to increase contextual meaning and enhance overall data quality. Real time remote data reporting improves participant care, safety and compliance monitoring. Two-way site to subject messaging enhances interaction between the research team and study participants. Clinical Trial Solutions Health Research Solutions 4 Reliable in-home sleep/wake measurement ActiGraph delivers objective information about a patient’s real world sleep behavior and rest-activity rhythms, helping physicians make appropriate diagnostic and treatment decisions and providing measurable endpoints to research professionals investigating a wide range of influential factors. Advantages In-home actigraphy monitoring provides a validated, minimally invasive, and cost-effective alternative to lab based sleep studies Capture objective 24 hour data with one simple device to obtain valuable insight into the relationship between daytime activity and sleep/wake behavior. Advanced software platform delivers highly customizable sleep/ wake analytics, robust clinical data reporting options and a variety of mobile and web-based tools to streamline project workflow. Motivating healthy lifestyle choices Implementation of objective physical activity monitoring within a corporate wellness or health promotion program is a powerful way to engage and motivate participants to adopt healthier behaviors, while delivering measurable results on participation and outcomes. Advantages Obtain measurable insight on participant behaviors, health status, and wellness program adherence and success. Foster participant engagement through real-time mobile feedback and access to an interactive web portal, resulting in long term program adherence and improved health outcomes. Real-time remote data reporting allows program administrators to monitor participants and implement personalized coaching as needed. Wellness Solutions Sleep Assessment Solutions 5 Integrated Monitoring Solutions At ActiGraph, we understand that a one size fits all approach to objective patient monitoring fails to take into account the diverse needs of each project based protocol, endpoints, subject populations, and other factors. Our innovative hardware and software solutions platform offers a complete suite of integrated mobile and web-based tools that can be configured to achieve the unique communication, reporting and analysis requirements of your study. 6 Secure Cloud Admin Portal Subject/Patient Portal Mobile AppsActiGraph Monitors ActiLife API Subject/Patient Environment Research Environment Hardware Solutions Backed by more than a decade o…

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www.theactigraph.com P a g e | 1 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 wGT3X-BT User’s Manual Document No. M OS13 DOC09 Revis ion: D www.theactigraph.com P a g e | 2 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Change Page About the change page table The following table describes the changes that have been made to this document since its original baseline. Documents affected by the changes made need to be listed and updated to keep procedures up to date. This table shall be maintained as long as this document is active. Revision Description of Change/Documents Affected Effective Date A - Initial Release 5/31/13 B - Made numerous changes to obtain regulatory approval 8/20/13 C - On page 6 the Class II medical device symbol was changed from FDA to square within a square symbol. Updated the Appendix. Updated the battery life tables. 10/31/13 D - Updated FCC 15.105 digital devices statement 1/17/14 www.theactigraph.com P a g e | 3 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Document Approval Printed Name of Document Creator or Editor: ______________________________ Printed Name of Reviewing Manager: ______________________________ ☐ Approved Signature: ________________________ Date and Time: ________________________ Printed Name of Reviewing Quality Department Representative: ________________________________ Signature: ________________________ Effective Date: _________________________ *Hard copies are to be printed, signed, and kept on file with the Quality Department. www.theactigraph.com P a g e | 4 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Table of Contents Important Information and Symbols ............................................................................................................ 6 Introduction ................................................................................................................................................ 10 Specifications and Functionality of the wGT3X-BT ..................................................................................... 10 Data ......................................................................................................................................................... 10 Acceleration ........................................................................................................................................ 10 Ambient Light ...................................................................................................................................... 10 Steps .................................................................................................................................................... 11 Inclinometer ........................................................................................................................................ 11 Low Frequency Extension ................................................................................................................... 12 Data Collection .................................................................................................................................... 12 Water Resistance ................................................................................................................................ 13 Wireless ................................................................................................................................................... 13 Heart Rate ........................................................................................................................................... 13 Wireless Reporting and Control .......................................................................................................... 13 Battery..................................................................................................................................................... 14 Low Voltage Mode (HALT) .................................................................................................................. 17 Recharging and LED Decoding ............................................................................................................ 17 Wearing the Device ................................................................................................................................. 19 Miscellaneous Device Information ............................................................................................................. 19 Degradable Components ........................................................................................................................ 19 Other Possible Negative Effects .............................................................................................................. 19 Wear Locations ....................................................................................................................................... 19 Device Serial Number Label .................................................................................................................... 20 Cleaning the Device ................................................................................................................................ 20 Device Storage and Life Expectancy ....................................................................................................... 20 Device Maintenance ............................................................................................................................... 20 www.theactigraph.com P a g e | 5 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Accessories .............................................................................................................................................. 20 Replacement of Parts Subject to Deterioration .................................................................................. 21 Connection and d…

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PHOTOGRAPHS, EUT EXTERNAL ActiGraph, LLC - wGT3X-BT

PHOTOGRAPHS, EUT INTERNAL ActiGraph, LLC - wGT3X-BT

PHOTOGRAPHS - INTERNAL ActiGraph wGT3X-BT

-091213 Report Number: F2LQ5768-05E Page 1 of 7 Issue Date: Feb. 10, 2014 F2 Labs 16740 Peters Road Middlefield, Ohio 44062 United States of America www.f2labs.com CERTIFICATION TEST REPORT Manufacturer: ActiGraph, LLC 49 East Chase Street Pensacola, Florida 32502 United States of America Applicant: Same As Above Product: Ambulatory Activity Monitor Model: wGT3X-BT FCC ID: DFW-02 Testing Commenced: Oct. 8, 2013 Testing Ended: Jan. 29, 2014 Summary of Test Results: Page 4 Standards: • OET FCC Bulletin 65 • KDB447498 Evaluation Conducted by: Ken Littell, EMC Tech. Mgr. Report Reviewed by: Wendy Fuster, President F2 Labs F2 Labs 26501 Ridge Road 16740 Peters Road Damascus, MD 20872 Middlefield, OH 44062 Ph 301.253.4500 Ph 440.632.5541 Fax 301.253.5179 Fax 440.632.5542 This test report may be reproduced in full; partial reproduction only may be made with the written consent of F2 Labs. The results in this report apply only to the equipment tested. Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 2 of 7 Issue Date: Feb. 10, 2014 TABLE OF CONTENTS Section Title Page 1 ADMINISTRATIVE INFORMATION 3 2 SUMMARY OF TEST RESULTS/MODIFICATIONS 4 3 ENGINEERING STATEMENT 5 4 EUT INFORMATION AND DATA 6 5 RF EXPOSURE FOR DEVICE >20cm FROM HUMAN 7 Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 3 of 7 Issue Date: Feb. 10, 2014 1 ADMINISTRATIVE INFORMATION 1.1 Measurement Location: F2 Labs in Middlefield, Ohio. Site description and attenuation data are on file with the FCC's Sampling and Measurement Branch at the FCC Laboratory in Columbia, MD. 1.2 Measurement Procedure: All measurements were performed according to KDB558074. 1.4 Document History Document Number Description Issue Date Approved By F2LQ5768-05E First Issue Feb. 10, 2014 W. Fuster Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 4 of 7 Issue Date: Feb. 10, 2014 2 SUMMARY OF TEST RESULTS Test Name Standard(s) Results RF Exposure for Device >20cm from Human OET FCC Bulletin 65 KDB447498 Complies Note: product was operated using AAA batteries. Modifications Made to the Equipment None Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 5 of 7 Issue Date: Feb. 10, 2014 3 ENGINEERING STATEMENT This report has been prepared on behalf of ActiGraph, LLC. to provide documentation for the testing described herein. This equipment has been tested and found to comply with OET FCC Bulletin 65 and KDB447498. The test results found in this test report relate only to the items tested. Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 6 of 7 Issue Date: Feb. 10, 2014 4 EUT INFORMATION AND DATA 4.1 EUT INFORMATION AND DATA 4.1 Equipment Under Test: Product: Ambulatory Activity Monitor Model: wGT3X-BT Serial No.: None FCC ID: DFW-02 4.2 Trade Name: ActiGraph, LLC 4.3 Power Supply: Non-rechargeable Internal Batteries 4.4 Applicable Rules: • OET FCC Bulletin 65 • KDB447498 4.5 Equipment Category: Radio Transmitter-DTS 4.6 Antenna: 0.5dBi gain Integral Chip antenna 4.7 Accessories: N/A 4.8 Test Item Condition: The equipment to be tested was received in good condition. Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 012413 Report Number: F2LQ5768-05E Page 7 of 7 Issue Date: Feb. 10, 2014 5. RF EXPOSURE FOR DEVICE >20cm FROM HUMAN 5.1 Limit: 10W/m 2 Formula used for result: E.I.R.P. 4 π R 2 Results: E.I.R.P. with .5dBi antenna: .26853mW at the 2440 MHz Mid Channel, which is the highest. The device is exempt from the requirement due to its low output power.

091213 Report Number: F2LQ5768-01E Rev. 2 Page 1 of 78 Issue Date: Jan. 30, 2014 F2 Labs 16740 Peters Road Middlefield, Ohio 44062 United States of America www.f2labs.com CERTIFICATION TEST REPORT Manufacturer: ActiGraph, LLC 49 East Chase Street Pensacola, Florida 32502 United States of America Applicant: Same As Above Product: Ambulatory Activity Monitor Model: wGT3X-BT FCC ID: DFW-02 Testing Commenced: Oct. 8, 2013 Testing Ended: Jan. 29, 2014 Summary of Test Results: 5 Rules:
FCC Part 15 Subpart C, Section 15.247
FCC Part 15, Subpart C, Section 15.207 Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 2 of 78 Issue Date: Jan. 30, 2014 Evaluation Conducted by: Joe Knepper, EMC Proj. Eng. Ken Littell, EMC Tech. Mgr. Report Reviewed by: Wendy Fuster, President F2 Labs F2 Labs 26501 Ridge Road 16740 Peters Road Damascus, MD 20872 Middlefield, OH 44062 Ph 301.253.4500 Ph 440.632.5541 Fax 301.253.5179 Fax 440.632.5542 This test report may be reproduced in full; partial reproduction only may be made with the written consent of F2 Labs. The results in this report apply only to the equipment tested. Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 3 of 78 Issue Date: Jan. 30, 2014 TABLE OF CONTENTS Section Title Page 1 ADMINISTRATIVE INFORMATION 4 2 SUMMARY OF TEST RESULTS/MODIFICATIONS 5 3 TABLE OF MEASURED RESULTS 6 4 ENGINEERING STATEMENT 7 5 EUT INFORMATION AND DATA 8 6 LIST OF MEASUREMENT INSTRUMENTATION 9 7 FCC Part 15.247(a)(2) – -6dB Occupied Bandwidth 10 8 FCC Part 15.247(b)(3) – Conducted Output Power 14 9 FCC Part 15.247(d) – Conducted Spurious Emissions 18 10 Radiated Spurious Emission 31 11 FCC PART 15.247 – Peak Power Spectral Density (PSD) 60 12 FCC PART 15.207 – Conducted Emissions 63 13 Photos/Exhibits – Product Photos, Test Setups 76 Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 4 of 78 Issue Date: Jan. 30, 2014 1 ADMINISTRATIVE INFORMATION 1.1 Measurement Location: F2 Labs in Middlefield, Ohio. Site description and attenuation data are on file with the FCC's Sampling and Measurement Branch at the FCC Laboratory in Columbia, MD. 1.2 Measurement Procedure: All measurements were performed according to the 2003 version of ANSI C63.4 and recommended FCC procedure of measurement of DTS operating under Section 15.247 and in KDB558074. A list of the measurement equipment can be found in Section 6. 1.3 Uncertainty Budget: Radiated Emission
Combined Uncertainty (+ or -) 2.24 dB
Expanded Uncertainty (+ or -) 4.48 dB This uncertainty represents an expanded uncertainty expressed at approximately the 95% confidence level using a coverage factor of k=2. 1.4 Document History Document Number Description Issue Date Approved By F2LQ5768-01E First Issue Nov. 21, 2013 W. Fuster F2LQ5768-01E Rev. 1 Revisions for TCB feedback Jan. 21, 2014 W. Fuster F2LQ5768-01E Rev. 2 Addition of test results for 15.207 Jan. 30, 2014 W. Fuster Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 5 of 78 Issue Date: Jan. 30, 2014 2 SUMMARY OF TEST RESULTS Test Name Standard(s) Results -6dB Occupied Bandwidth CFR 47 Part 15.247(a)(2) / KDB558074 Complies Conducted Output Power CFR 47 Part 15.247(b)(3) / KDB558074 Complies Conducted Spurious Emissions CFR 47 Part 15.247(d) / Part 15.209 / KDB558074 Complies Radiated Spurious Emission with 0.5dBi Integral Antenna CFR 47 Part 15.247(d) / Part 15.209 / KDB558074 Complies Peak Power Spectral Density CFR 47 Part 15.247(e) / KDB558074 Complies Conducted Emissions CFR 47 Part 15.207(a) Complies Modifications Made to the Equipment None Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 6 of 78 Issue Date: Jan. 30, 2014 3 TABLE OF MEASURED RESULTS Test High Channel 2.480GHz Mid Channel 2.440GHz Low Channel 2.405GHz Conducted Output Power .24322mW (-6.14dBm) .23933mW (-6.21dBm) .24322mW (-6.14dBm) Conducted Output Power Limit 1 Watt, (30dBm) 1 Watt, (30dBm) 1 Watt, (30dBm) E.I.R.P. with 0.5dBi Integral antenna .27289mW (-5.64dBm) .26853mW (-5.71dBm) .27289mW (-5.64dBm) E.I.R.P. Limit 4 Watts, (36.02dBm) 4 Watts, (36.02dBm) 4 Watts, (36.02dBm) Peak Power Spectral Density -17.62 dBm -15.96 dBm -15.9 dBm Peak Power Spectral Density Limit 8 dBm 8 dBm 8 dBm -6dB Occupied bandwidth 1.0896 MHz 1.0956 MHz 1.0989 MHz -6dB Occupied Bandwidth Limit ≥ 500KHz ≥ 500KHz ≥ 500KHz Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 7 of 78 Issue Date: Jan. 30, 2014 4 ENGINEERING STATEMENT This report has been prepared on behalf of ActiGraph, LLC to provide documentation for the testing described herein. This equipment has been tested and found to comply with Part 15.247 and Part 15.207 of the FCC Rules using ANSI C63.4 2003 and KDB558074 standards. The test results found in this test report relate only to the items tested. Order Number: F2LQ5768 Client: ActiGraph, LLC Model: wGT3X-BT 091213 Report Number: F2LQ5768-01E Rev. 2 Page 8 of 78 Issue Date: Jan. 30, 2014 5 EUT INFORMATION AND DATA 5.1 Equipment Under Test: Product: Ambulatory Activity Monitor Model: wGT3X-BT Serial No.: None FCC ID: DFW-02 5.2 Trade Name: ActiGraph, LLC 5.3 Power Supply: Rechargeable Internal Battery 5.4 Applicable Rules: CFR 47, Part 15.247, subpart C CFR 47, Part 15.207 5.5 Equipment Category: Radio Transmitter-DTS 5.6 Antenna: 0.5dBi gain Integral Chip Antenna 5.7 Accessories: N/A 5.8 Test Item Condition: The equipment to be tested was received in good condition. 5.9 Testing Algorithm: The EUT was configured to permit frequency changes from low-mid-upper transmission channel using digital modulation (required for digital transmission systems). For RF antenna conducted tests, the EUT was equipped with an SMA connector for connection to the measuring equipment. …

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PHOTOGRAPHS, TEST SETUPS ActiGraph, LLC - wGT3X-BT Radiated Spurious Emission with 0.5dBi Integral Antenna Radiated Spurious Emission with 0.5dBi Integral Antenna, cont’d Conducted Output Power, Peak Power Spectral Density, -6dB Occupied Bandwidth, and Conducted Spurious Emissions Conducted Emissions