ActiGraph wGT3X-BT User Manual Download

Page: 23 / 23

www.theactigraph.com

P a g e

49 E. Chase St. Pensacola, FL 32502 tel 850.332-7900 fax 850-332-7904

Appendix

Risk Management Documentation

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

MOS13DOC04

Design Requirements

10/16/13

MOS13DOC05

Risk Management Plan

10/16/13

MOS13DOC06

Development Life-Cycle

8/20/13

MOS13DOC07

Risk Management Summary

10/16/13

MOS13TRD01

Moses Verification Plan

3/21/13

Summary of Contents for wGT3X-BT

Page 1: ...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 MOS13DOC09 Revision D ...

Page 2: ...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 Upda...

Page 3: ...nted 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 ...

Page 4: ...eps 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 Devic...

Page 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 disconnect of detachable accessories 21 Appendix 23 Risk Management Documentation 23 ...

Page 6: ...y when being charged1 CAUTION Transporting or operating these devices outside of the temperature range of 20o C to 60o 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 h...

Page 7: ...es 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 Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to whi...

Page 8: ...vice Le présent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autorisée aux deux conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l utilisateur de l appareil doit accepter tout brouillage radioélectrique subi même si le brouillage est susceptible d en compromettre le fonctionnement The devices comply ...

Page 9: ...ducts Environmental Conditions Do not expose the devices to temperatures outside the limitations of 20o C to 60o C If a device is going to be exposed to temperatures higher than 60o C keep the device isolated from the user If a device is going to be exposed to temperatures lower than 20o C keep the device as close to the user as possible to try and insulate the device ...

Page 10: ...nt dust or direct sunlight Acceleration The devices include an acceleration sensor 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 sto...

Page 11: ... 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 ...

Page 12: ...or 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 ...

Page 13: ...ttery 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 w...

Page 14: ...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...

Page 15: ...uter 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 16: ... Memory Limit Days 30 29 120 40 28 95 50 27 75 60 26 64 70 25 54 80 24 48 90 23 42 100 22 38 Table 5 Battery life based on 16 Hrs Active 8 Hrs sleep wGT3X BT Sample Rate Hz Battery Life Days Memory Limit Days 30 20 120 40 20 95 50 19 5 75 60 19 64 70 18 5 54 80 18 48 90 17 5 42 100 17 38 Table 6 Battery life based on no sleep 24 hrs active ...

Page 17: ...utomatic 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 h...

Page 18: ...d the unit has entered Halt Mode Green LED No Flashing LED Off Actively collecting data Flash Mode disabled or battery dead 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 mo...

Page 19: ...ith 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 effected Miscellaneous Device Information Degradable Components ActiGraph s devices are made with high quality components that are not subject to deterioration over time T...

Page 20: ...uggested 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 time ...

Page 21: ... have 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 ...

Page 22: ...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 4 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 m...

Page 23: ...nal ActiGraph documents created or used to comprise the Risk Management File for the wGT3X BT device Document Number Description Revision Effective Date MOS13DOC04 Design Requirements D 10 16 13 MOS13DOC05 Risk Management Plan C 10 16 13 MOS13DOC06 Development Life Cycle B 8 20 13 MOS13DOC07 Risk Management Summary C 10 16 13 MOS13TRD01 Moses Verification Plan D 3 21 13 ...

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