DFW-01Wireless Ambulatory Activity Monitor

www.theactigraph.com P a g e | 1 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 User’s Manual for the wGT3X+ and wActiSleep+ 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. This table shall be maintained as long as this document is active. Revision Brief Description of Change Date of Approval A Initial version 5/30/2012 www.theactigraph.com P a g e | 3 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Table of Contents Important Information and Symbols ............................................................................................................ 4 Introduction .................................................................................................................................................. 7 Specifications and Functionality of the wGT3X+ and wActiSleep+ ............................................................... 7 Data ........................................................................................................................................................... 7 Acceleration .......................................................................................................................................... 7 Ambient Light ........................................................................................................................................ 7 Steps ...................................................................................................................................................... 8 Inclinometer .......................................................................................................................................... 8 Low Frequency Extension ..................................................................................................................... 9 Data Collection ...................................................................................................................................... 9 Water Resistance ................................................................................................................................ 10 Wireless ................................................................................................................................................... 10 Sensor Connectivity ............................................................................................................................ 10 Wireless Reporting and Control .......................................................................................................... 10 Battery..................................................................................................................................................... 11 Low Voltage Mode (HALT) .................................................................................................................. 13 Recharging and LED Decoding ............................................................................................................ 13 Wearing the Device ..................................................................................................................................... 15 www.theactigraph.com P a g e | 4 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 Important Information and Symbols The wGT3X+ and wActiSleep+ devices abide by the following regulations listed below and give explanation into the symbols that are found on each device. These symbols and statements apply to both the wGT3X+ device and the wActiSleep+. The devices are compliant with IEC (International Electrotechnical Commission) standards for "Type BF Applied Part" - meaning they comply with requirements for protection against electrical shock. CAUTION: Do not simultaneously charge and wear the device. The end user should not be in the patient vicinity when being charged 1 CAUTION: Transporting or operating these devices outside of the temperature range of -20 o C to +60 o C could lead to dangerous conditions and/or incorrect data collection. Class II medical device  FCC Part 15.107 – AC Conducted Emissions  FCC Part 15.109 – Radiated Emissions  FCC Part 15.207 – Modular Transmitter AC Line Conducted Emissions  FCC Part 15.249 – Radiated Emission Limits of Intentional Radiators These devices comply with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by ActiGraph, LLC will void the user's authority to operate the equipment under FCC regulations. 1 A patient vicinity is areas in which PATIENTS are normally cared for and the space with surfaces likely to be contacted by the PATIENT or an attendant who can touch the PATIENT. This encloses a space within the room 1,83 m (6 feet) beyond the perimeter of the bed (examination table, dental chair, treatment booth, and the like) in its intended location, and extending vertically 2,29 m (7- 1/2 feet) above the floor. www.theactigraph.com P a g e | 5 49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904 These devices are classified as Class I medical devices within the European Union and have been approved to be sold as medical devices according to the European Union's regulatory requirements listed below:  EN 60601-1: 1988 + A1: 1991 + A2: 1995 – Medical Electrical Equipment Part 1: General Requirements for Safety  EN 60601-1-2:2007, inc. C:2010 – Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and tests IEC 60601-1-2 (Modified)…

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Label Size and Location BARCODE 1-1/8” 7/16”

FCC ID: DFW-01 IC: 10333A-01 14/16" 1/2" Device Battery 1" 1" FCC ID: DFW-01 IC: 10333A-01

This report contains a total of 38 pages and may be reproduced in full only. Partial reproduction may only be done with the written consent of CKC Laboratories, Inc. Actigraph, LLC TEST REPORT FOR Ambulatory Activity Monitor, wGT3X+ Tested To The Following Standards: FCC Part 15 Subpart C Sections 15.207, 15.249 and RSS 210 Issue 8 Report No.: 92567-10 Date of issue: February 22, 2012 This test report bears the accreditation symbol indicating that the testing performed herein meets the test and reporting requirements of ISO/IEC 17025 under the applicable scope of EMC testing for CKC Laboratories, Inc. We strive to create long-term, trust based relationships by providing sound, adaptive, customer first testing services. We embrace each of our customers’ unique EMC challenges, not as an interruption to set processes, but rather as the reason we are in business. Page 2 of 38 Report No.: 92567-10 TABLE OF CONTENTS Administrative Information ........................................................................................................................................... 3 Test Report Information ............................................................................................................................................ 3 Report Authorization ................................................................................................................................................. 3 Test Facility Information ............................................................................................................................................ 4 Site Registration & Accreditation Information .......................................................................................................... 4 Summary of Results ................................................................................................................................................... 5 Conditions During Testing.......................................................................................................................................... 5 Equipment Under Test ............................................................................................................................................... 6 Peripheral Devices ..................................................................................................................................................... 6 FCC Part 15 Subpart C .................................................................................................................................................... 7 15.31(e) Voltage Variations ....................................................................................................................................... 7 15.207 AC Conducted Emissions ................................................................................................................................ 9 15.247 RF Power Output ......................................................................................................................................... 16 -20dBc Occupied Bandwidth ................................................................................................................................... 21 Bandedge ................................................................................................................................................................. 25 15.249(b) / (d) Field Strength of Harmonics / Spurious Emissions .......................................................................... 29 RSS-210 ........................................................................................................................................................................ 33 99 % Bandwidth ....................................................................................................................................................... 33 Supplemental Information .......................................................................................................................................... 37 Measurement Uncertainty ...................................................................................................................................... 37 Emissions Test Details .............................................................................................................................................. 37 Page 3 of 38 Report No.: 92567-10 ADMINISTRATIVE INFORMATION Test Report Information REPORT PREPARED FOR: REPORT PREPARED BY: Actigraph, LLC 49 East Chase St. Pensacola, FL 32502 Dianne Dudley CKC Laboratories, Inc. 5046 Sierra Pines Drive Mariposa, CA 95338 Representative: Adam Simon / Erin Littell (F-Squared) Project Number: 92567 Customer Reference Number: 2161 DATE OF EQUIPMENT RECEIPT: February 8, 2012 DATE(S) OF TESTING: February 8-13, 2012 Report Authorization The test data contained in this report documents the observed testing parameters pertaining to and are relevant for only the sample equipment tested in the agreed upon operational mode(s) and configuration(s) as identified herein. Compliance assessment remains the client’s responsibility. This report may not be used to claim product endorsement by A2LA or any government agencies. This test report has been authorized for release under quality control from CKC Laboratories, Inc. Steve Behm Director of Quality Assurance & Engineering Services CKC Laboratories, Inc. Page 4 of 38 Report No.: 92567-10 Test Facility Information Our laboratories are configured to effectively test a wide variety of product types. CKC utilizes first class test equipment, anechoic chambers, data acquisition and information services to create accurate, repeatable and affordable test results. TEST LOCATION(S): CKC Laboratories, Inc. 110 Olinda Place Brea, CA 92823 Site Registration & Accreditation Information Location CB # Japan Canada FCC Brea A US0060 R-2945, C-3248 & T-1572 3082D-1 90473 Page 5 of 38 Report No.: 92567-10 …

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