wGT3X-BT User`s Manual
Contents
1. Page 8 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Rr Contact ActiGraph Customer Service regarding the disposal of these products Do not expose the devices to temperatures outside the limitations of 20 C to 60 C Ifa Environmental device is going to be exposed to temperatures higher than 60 C keep the device isolated C di H from the user If a device is going to be exposed to temperatures lower than 20 C keep onaitions i the device as close to the user as possible to try and insulate the device Page 9 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Introduction The wGT3X BT activity monitors provide objective measurements of human activity and are used in many research and clinical applications They include a microelectromechanical system MEMS based accelerometer ambient light and a touch sensor as data collection end points No formal training is required to use the wGT3X BT device and patients may be the intended operator This document will serve as the only necessary training guide needed to get full functionality from the device Specifications and Functionality of the wGT3X BT Data The devices include both an acceleration sensor as well as an ambient light sensor Data will not be negatively affected by lint dust or direct sunlight Acceleration The devices include an acceleration s2. The devices are compliant with IEC International Electrotechnical Commission standards for Type BF Applied Part meaning they comply with requirements for user protection against electrical shock The housing of the device is the only part that is to come into contact with the end user and is made out of Polycarbonate and or Polyvinyl Chloride materials If you have any allergic reactions to Polycarbonate and or Polyvinyl Chloride materials please consult your doctor before using an ActiGraph device CAUTION Do not simultaneously wear and charge service or provide any maintenance on the device The end user should not be in the patient vicinity when being charged CAUTION Transporting or operating these devices outside of the temperature range of 20 C to 60 C could lead to dangerous conditions and or incorrect data collection CAUTION Modification to ActiGraph devices is not permitted and will void all warranties if tampered and or modified Do not modify the device in any way CAUTION Do not swallow any part of this device If a piece has been swallowed contact your local poison control hotline or seek medical attention as soon as possible NOTICE Device does not have any contraindication s NOTICE Only use a USB 2 0 cable to connect to the device Only use ActiGraph approved USB hubs to charge the device Do not connect the device via the USB 2 0 port to anything else but a computer and ActiGraph approved USB hub
3. NOTICE No precautions need to be taken in the event of changes in the performance of the device Dj Class Il medical device LA 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 Page 6 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com 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 eguipment under FCC regulations e FCC Part 15 107 AC Conducted Emissions e FCC Part 15 109 Radiated Emissions e FCC Part 15 207 Modular Transmitter AC Line Conducted Emissions e FCC Part 15 249 Radiated Emission Limits of Intentional Radiators Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC Rules These lim
4. the device firmware filters out the accelerometer s baseline noise level to help accurately accumulate the steps per epoch Inclinometer The inclinometer feature can help users identify the orientation of the device and more importantly when the device itself was taken off Each epoch is flagged with a number 1 through 4 to indicate the orientation of the device during that epoch For wGT3X BT devices this is done within the ActiLife software when converting the gt3x file to agd format As noted the inclinometer feature is only valid when the device is worn vertically on the point of the hip More details are available in the Inclinometer Whitepaper Important The inclinometer feature is only valid if the device is worn on the hip with Axis 1 upward facing Inclinometer Code Interpretation Stored with each Epoch 0 Device Off Not Being Worn 1 Subject Standing 2 Subject Lying Horizontal 3 Subject Sitting Table 3 Inclinometer Definitions Page 11 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Off Indication on WGT3X BT versus other devices The Inclinometer feature offers researchers the ability to detect periods of time during which the device was not worn For devices other than the wGT3X wActiSleep GT3X and ActiSleep the inclinometer algorithm makes this prediction by examining the angle at which the device is placed In the wGT3
5. 2502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Wearing the Device All ActiGraph activity monitors are designed to monitor human activity and record energy expenditure calories spent during normal activity METs everyday activity and exercise Additionally these devices can also function as a very accurate sleep assessment tool While collecting day to day energy expenditure data the device should be affixed securely to the body s center of mass to ensure the most accurate caloric measurements Wrist worn non validated EE for kids is now available for 3 axis ActiGraph devices When being used for sleep assessment ActiGraph devices may be worn anywhere on the body wrist waist hip arm or ankle It is recommended that children under 12 years of age wear ActiGraph devices on the elastic belt versus the adhesive belt clip as it is the most secure way to wear the device Belt loop pouches wrist and ankle straps are also available If irritation of the skin occurs due to wearing the device discontinue wearing the device and consult a doctor for treatment Although the Polycarbonate and Polyvinyl Chloride materials are not known to be irritating to the skin some irritation to individuals with sensitive skin may occur If this happens consult your doctor for treatment and stop wearing the device Also notify the individual that issued the device to you that you have taken the device off since data collection will be effe
6. C 60601 1 2 Modified e EN 61000 4 2 2009 Electromagnetic Compatibility Part 4 Testing and measurement techniques Section 2 Electrostatic discharge immunity test e EN 61000 4 3 2006 inc A2 2010 Electromagnetic Compatibility Part 4 Testing and measurement techniques Section 3 Radiated radio frequency electromagnetic field immunity test e EN 61000 4 8 2010 Electromagnetic Compatibility Part 4 Testing and measurement techniques Section 8 Power frequency magnetic field immunity test Page 7 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com e EN 55011 2009 inc A1 2010 Limits and methods of measurement of radio disturbance characteristics of industrial scientific and medical radio frequency equipment e EN 301 489 1 Electromagnetic compatibility and Radio spectrum Matters ERM ElectroMagnetic Compatibility EMC standard for radio equipment and services Part 1 Common technical requirements e EN 301 489 3 V1 4 1 Electromagnetic compatibility and Radio spectrum Matters ERM Electromagnetic Compatibility EMC standard for radio equipment Part 3 Specific conditions for Short Range Devices SRD operating on frequencies between 9kHz and 40GHz Industry Industrie kell Canada Canada isi Canada Australia New Zealand The devices comply with Industry Canada license exempt RSS standard s Operation is subject to the follow
7. X wActiSleep GT3X and ActiSleep devices off detection is performed by analyzing both the angle at which the unit is placed as well as the length of time the device remains still Absolute stillness for three 3 minutes indicates that the unit is likely in an off condition regardless of orientation As such epochs that follow three motionless minutes of activity are flagged as off i e the inclinometer code is equal to zero These values are not retroactive That is the first three minutes of zero activity are not flagged as off In addition 30 minutes in the off orientation will cause the inclinometer value to indicate off after that time period has elapsed regardless of motion At this time the inclinometer feature is being validated by the research community Low Frequency Extension The Low Frequency Extension LFE option though not a mode or channel is another data collection option during post processing for the wGT3X BT The Normal proprietary filter algorithm used in ActiGraph products is used to eliminate any acceleration noise outside of the normal human activity frequency bandwidth This filter is customized to work with ActiGraph s Energy Expenditure Algorithms The LFE option when enabled extends the lower end baseband of the filter cutoff effectively expanding the bandwidth of the accumulated data This option is useful when measuring actigraphy data for subjects who move slowly or take very ligh
8. ata Contact customer support at support theactigraph com Green LED 1 Flash Battery Charging Steady On Battery Fully Charged Device Not Connected to PC Red LED Fault Indicator No Flashing Normal operating condition or battery dead LED Off 2 Flashes Low Battery use ActiLife Lifestyle software to check for remaining battery life The unit needs to be recharged 3 Flashes Unexpected Battery Failure Temporary battery power loss or Battery Level has fallen below 3 1V and the unit has entered Halt Mode Green LED No Flashing Actively collecting data Flash Mode disabled or battery dead LED Off 1 Flash Delay before start mode the LED always flashes prior to starting data collection Actively taking data Flash Mode enabled not recommended 2 Flashes N A 3 Flashes End of memory reached Device no longer collecting data Battery died while unit was in delay before start mode no data collected on device Wireless Feature Enabled Actively paired with and receiving Heart Rate data Actively paired and communicating with ActiLife or ActiLife Mobile Note The Red LED will ALWAYS flash to indicate LOW BATTERY regardless of whether Flash Mode is enabled or disabled If a stop time optional has been reached the Green LED will stop flashing all together regardless of its previous state 1 Flash Every 3 Seconds Table 7 wGT3X BT LED Reference Table Page 18 49 E Chase St Pensacola FL 3
9. cted Miscellaneous Device Information Degradable Components ActiGraph s devices are made with high quality components that are not subject to deterioration over time The battery within each device is the only component that has a determined life expectancy 5 years If a device seems to be under performing call ActiGraph s Customer Service department immediately so the problem may be resolved Batteries are only to be changed by ActiGraph trained personnel Other Possible Negative Effects Pets have the potential to destroy a device Keep devices away from pets and other animals that may chew on bite urinate on swallow and destroy a device in any other method imaginable Wear Locations ActiGraph s devices can be worn in 6 different locations the ankle thigh in a pants pocket on the waist wrist or on a lanyard around the neck When initializing the wGT3X BT device within ActiLife choose the appropriate wear location to ensure accurate data collection 2 Sleep analysis can also be performed by purchasing ActiGraph s ActiSleep analysis program which is part of the Virtual Trainer web based analysis software Formulas for this tool were developed by Dr Avi Sadeh Department of Psychology Tel Aviv University Page 19 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Device Serial Number Label Each ActiGraph device is eguipped with a label stuck to it with pertinent device i
10. ctiGraph s new ActiLife Mobile available on the iPhone platform Device Status Device specific status information can be obtained Some of the items retrieved include firmware version battery voltage current mode subject name and device serial number Page 13 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Stopping the device In order to stop the device from collecting data the device needs to be plugged into and computer with the ActiLife Software running One easy way to stop the device from collecting data is to set a stop time during initialization Once a device is told to stop it will go into HALT mode and go into a low power stopped state Another way to get a device to stop collecting data is to plug it into a computer with the ActiLife Software running and update the firmware on the device This also will put it into HALT mode and have the device go into a lower power stopped state Unexpected operations and events If a device performs in an unexpected manner and does not collect data does not perform as long as expected will not download data or acts in any other manner that is unexpected notify ActiGraph immediately ActiGraph s Customer Service can be contacted at the phone number 877 497 6996 and is available every week Monday through Friday 8A M to 5P M Central Standard Time Customer Service may also be contacted through email at support theactigraph com Househol
11. d Interference Within a household environment many different factors can negatively affect the device Putting a device close to hot sources such as a fireplace and baseboard heater will melt the housing of a device and destroy it Putting a device in the freezer for extended periods of time will reduce the capacity of the battery s lifespan and negatively affect its performance Putting a device in a microwave will destroy various parts of the device and possibly completely destroy it Wireless internet connections wireless television service and other wireless services will not negatively affect the performance of the device As a rule of thumb do not put the device in extreme cold or hot temperatures and do not apply any electrical sources to the device unless explicitly approved and described by ActiGraph Battery All ActiGraph devices use a lithium polymer rechargeable battery that has a maximum voltage of approximately 4 20 volts and have a total life expectancy of five 5 years Even though these batteries are replaceable only ActiGraph personnel are to replace the batteries At 3 1 volts the devices enter a low voltage mode state HALT mode In order to slow the aging of the lithium polymer battery it is recommended that devices be stored ina partially charged state 40 60 battery capacity in low ambient temperatures Every three 3 months plug the devices in to monitor their voltages and to extend the life expectancy of the bat
12. ensor that consists of a microelectromechanical systems MEMS accelerometer yielding the following product specifications Parameter Value Units Axis 3 Sensitivity 4 mg LSB Dynamic Range 8 g Table 1 Accelerometer Key Specifications The acceleration data is stored at rates ranging from 30 Hz to 100 Hz user selectable and stored in a raw non filtered accumulated format in the units of gravity g s This data is stored directly into a non volatile flash memory The accelerometer is very sensitive and is accurate within 0 5 of the data collected Ambient Light Ambient light data is sampled and stored to memory at a 1 Hz rate When a downloaded data file is converted into an accumulated agd format with epoch lengths greater than one second the lux values for that epoch are averaged An estimate of lux values is shown in Table 1 Lux Level Interpretation Comparison 1 Twilight 50 Family living room Page 10 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com 100 Very dark overcast day 320 500 Office lighting 400 Sunrise sunset 1 000 Overcast day 10 000 25 000 Full daylight 32 000 130 000 Direct sunlight Table 1 Lux Level Interpretation Estimates Steps Step counts are accumulated on a per epoch basis and are based on accelerometer data collected on the vertical axis An algorithm present in
13. ery oo eccceecccsscceseeceseeceeceeeeceseeseseeeuees Low Voltage Mode HALT mmm Recharging and LED Decoding Wearing the Device oooooWc W W oo Miscellaneous Device Information Degradable Component ooo W W Other Possible Negative Effects Wear LoOCatiOnS ooooWo WWo Woo Device Serial Number Label ooooo Cleaning the Device WoooWJW oo Device Storage and Life Expectancy Device Maintenance oooo oo 49 E Chase St Pensacola FL 32502 www theactigraph com tel 850 332 7900 fax 850 332 7904 www theactigraph com PECOS SONO Sern AAAS Nee 20 Replacement of Parts Subject to Deterioration ooooooWooWo Wo Won 21 Connection and disconnect of detachable accessories icoooooooo WoWoo om 21 ma an 23 Risk Management Documentation oooooWoWoW WWW W Jaa 23 Page 5 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Important Information and Symbols The wGT3X BT device abides by the following regulations listed below and gives explanation into the symbols that are found on each device CAUTION The battery is to only be changed by trained ActiGraph personnel The battery is only allowed to be connected in a certain manner and any incorrect replacement can result in a hazard
14. ing two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Le present appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autoris e aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement The devices comply with the Australian and New Zealand standards e AS NZS 4268 2008 Radio equipment and systems Short range devices e AS NZS CISPR 11 2011 Information technology equipment Radio disturbance characteristics Limits and methods of measurement e AS NZ CISPR 22 2009 Information technology equipment Radio disturbance characteristics Limits and methods of measurement Physiological Effects This device does not produce any known physiological effects Po This device is manufactured Lead Free and complies with RoHS standards Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment IP27 IPX7 The devices are water resistant in accordance with IEC 60529 and have the International Protection Rating IP27 formerly IPX7 or immersion in one 1 meter of water for up to 30 minutes
15. its are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one of more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help CE The devices are classified as Class 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 e EN 60601 1 3 Edition Medical Electrical Equipment Part 1 General Requirements for Safety e 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 IE
16. me so the life expectancy of a device is immeasurable Device Maintenance ActiGraph s devices do not require routine maintenance or calibration Calibration is done during the manufacturing of the device and will last for the life of the device If maintenance is required ona device or a piece of a device has gone missing call ActiGraph Customer Support or visit the support section on the ActiGraph website www actigraphcorp com and initiate an RMA for your device Any critical components that require maintenance are to be performed by trained ActiGraph personnel only All necessary training manuals schematics parts listings and other necessary documentation will be made available to the trained ActiGraph service technicians Accessories Accessories sold at ActiGraph are constantly changing due to the ever changing features available with the WGT3X BT device For a full list of current accessories available for the wGT3X BT device please visit ActiGraph s website www actigraphcorp com product category accessories Use the accessories Page 20 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com provided by ActiGraph only as described since the misuse of accessories and other detachable parts may be harmful to the user The life expectancy of each accessory is different since each accessory is subject to different elements The USB caps have a life expectancy of 1 3 years The Waist straps ha
17. nformation inside the serial number For example the serial number MRA3A29120016 means e MRA3 device model e A device model version e 29 week of the year it was manufactured 29 week e 12 year it was manufactured 2012 e 0016 number of device manufactured that week Cleaning the Device ActiGraph devices are approved to be cleaned with a non abrasive cloth and isopropyl alcohol The USB cap is to be inserted into the device and tightened prior to cleaning so no liquid can enter into the device and damage any of the internal electronics For optimal results apply isopropyl alcohol to the cloth clean the device for 15 20 seconds and let air dry ActiGraph devices are not to be sterilized because damage may occur Though ActiGraph devices are not required to be cleaned on any predetermined schedule it is advised that the devices be cleaned after each use by a user Device Storage and Life Expectancy There is no specific requirement for storing ActiGraph devices but a dry location with temperature limitations between 0 C and 50 C is suggested For optimal battery life expectancy routinely charge the device according to Table 4 The only limiting factor of an ActiGraph device when calculating life expectancy is the battery The battery has a life expectancy of five 5 years but can be replaced by ActiGraph personnel thus extending the life of the device The performance of the components inside the device does not degrade over ti
18. ressed raw gt3x agd Figure 1 Rie Water Resistance WGT3X BT devices are water resistant in accordance with IEC 60529 IPX7 or immersion in one 1 meter of water for up to 30 minutes Wireless In addition to the standard features and functionality of their predecessor devices wGT3X and waActiSleep the wGT3X BT provides a wireless interface by way of Bluetooth Smart wireless communication protocol This 2 4 GHz based interface allows for interoperability with millions of already fielded nodes as well as provides a means of rapidly gathering device and or subject information The wireless functionality can be disabled when not needed in order to increase battery life Heart Rate By way of Blue Tooth Smart chest straps the Moses is capable of measuring and storing both standard heart rate in Beats Per Minute BPM format as well as providing R to R measurements thus enabling the researcher to better understand heart the subject s activity profile Wireless Reporting and Control In addition to enhancing and increasing the sources for data collection the wireless functionality of the WGT3X BT enables the user to perform many functions that previously required USB connection or weren t possible before Many functions can now be performed in the field rather than requiring the researcher to be tethered to a computer in the lab Initialization The wGT3X BT can be fully initialized wirelessly This can be performed with A
19. s enter a Low Voltage Mode or HALT state when the battery discharges beyond a point of being able to power the device In this mode all important variables and data are stored in flash memory to secure the device download Because the device s internal clock stops in HALT mode the device cannot be recharged and redeployed the device must be downloaded and reinitialized to continue use Recharging and LED Decoding Recharging is automatic and is accomplished by connecting the device to a standard USB port with a USB 2 0 cable only Charging time will depend on the battery life but typically will not exceed three hours for a fully depleted battery to become fully charged Once the battery is completely charged the green LED will remain illuminated If the battery voltage drops below 3 1 volts while in use the device will not have sufficient power to collect data and will warn the user through a series of coded flashes see the below table for an explanation into WGT3X BT s LED flashes The battery level reported in volts can be viewed at any time by starting the ActiLife software and plugging in the device Important ActiLife will not allow initialization if the voltage is below 3 85 volts Page 17 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Device Connected to PC Red LED Fault Indicator 2 Flashes Battery is Faulty 3 Flashes A hardware failure occurred while recording d
20. t steps for example the elderly For more details contact ActiGraph at support theactigraph com Data Collection During initialization the user chooses the raw data sample frequency 30Hz up to 100Hz in 10Hz increments The wGT3X BT collects data from all on board sensors in raw data format Data recorded includes e Vertical Axis Activity Acceleration Data Axis 1 e Horizontal Axis Activity Acceleration Data Axis 2 e Perpendicular Axis Activity Acceleration Data Axis 3 e Ambient Light Lux Although Steps and Inclinometer are not directly measured during data collection these values can be derived from the 3 axis data during gt3x file decompression Unlike previous ActiGraph products the wGT3X BT does not filter or accumulate data into epochs Raw data is collected at the selected sample rate and is post processed in the ActiLife Because these devices collect data from all sensors at all times users can generate native ActiLife agd files containing any desired combination of parametric data at a later time This helps facilitate backward compatibility and Page 12 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com enhances the flexibility of the data by allowing users to compare data to studies which use different filter techniques or accumulation sizes e g 1 second epochs versus 60 second epochs ActiLife DeviceG Raw Samples Compressed Raw Filtering amp comp
21. tation Below is a required list of internal ActiGraph documents created or used to comprise the Risk Management File for the wGT3X BT device Document Number Description Revision Effective Date MOS13D0C04 Design Requirements D 10 16 13 MOS13DOC05 Risk Management Plan C 10 16 13 MOS13DO0C06 Development Life Cycle B 8 20 13 MOS13DOCO7 Risk Management Summary C 10 16 13 MOS13TRD01 Moses Verification Plan D 3 21 13 Page 23 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904
22. tery Table 4 demonstrates the impact of storage temperature and charge state on battery long term capacity Page 14 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Temperature Remaining capacity at 40 charge Remaining capacity at 100 charge recommended slorage charge level typical user charge level oc 98 after 1 year 94 after 1 year 26 C 96 after 1 year 80 after 1 year 40 C 85 after 1 yeer 65 after 1 year 60 C 75 after 1 year 60 after 3 monihs Table 4 Lithium Polymer Storage Note If a computer is not available or if multiple devices need to be recharged a self powered USB hub can be used IMPORTANT ActiGraph s devices do not come fully charged from the manufacturer and recommend the units be charged fully before their initial use If the battery performance is not performing as expected call ActiGraph s Customer Service immediately Page 15 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com WGT3X BT Battery Life Memory Limit Days Sample Rate Hz Table 5 Battery life based on 16 Hrs Active 8 Hrs sleep WGT3X BT Sample Rate Hz Battery Life Memory Limit Days Days Table 6 Battery life based on no sleep 24 hrs active Page 16 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Low Voltage Mode HALT ActiGraph device
23. ve a life expectancy of 5 years The Wrist straps have a life expectancy of 5 years These are not exact life expectancies but are suggested values that can be less or more depending on the use of the accessory Replacement of Parts Subject to Deterioration USB Cap Step 1 Pull cap out from strap by slipping strap from outer ridge Step 2 Insert strap into the cap s out ridge and twist the cap into the housing Connection and disconnect of detachable accessories Waist Strap 1 2 Step 1 Waist strap with plastic trident removed Step 2 Insert strap into either loop hole from the top of the device Page 21 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com 4 Step 3 From the bottom insert strap into the other loop hole and pull through Step 4 Reconnect the plastic trident to the strap and connect to plastic female end to secure waist belt Wrist Strap 1 2 Step 1 Wrist strap opened and fed through the bottom of one loop hole on the device Step 2 Insert the strap through the D ring and synch down 3 Step 3 Insert strap into the other loop hole from the bottom of the device Step 4 Insert wrist inside the strap and tighten the strap down as necessary to keep the device from moving but also for comfort Page 22 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Appendix Risk Management Documen
24. www theactigraph com wGT3X BT User s Manual Document No MOS13D0C09 Revision D Page 1 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Change Page About the The following table describes the changes that have been made to this document change page since its original baseline Documents affected by the changes made need to be table 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 On page 6 the Class II medical device symbol was changed C from FDA to square within a square symbol Updated the 10 31 13 Appendix Updated the battery life tables D Updated FCC 15 105 digital devices statement 1 17 14 Page 2 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 www theactigraph com Page 3 49 E Chase St Pensacola FL 32502 tel 850 332 7900 fax 850 332 7904 Table of Contents Important Information and Symbols Introduction esa Low Frequency Extension ooooooo Data Collection oooocooooooo Water Resistance oooooo Wireless ooooooooo Woo Woo oo mnnnatan Heart Rate a asem saban naas Wireless Reporting and Control Batt
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