User Manual Model: STAR WATCH BD1 Rev 0.10 2016 Pulsar Informatics, Inc. Important Information Table of Contents Important Information ..................................... 3 FCC ........................................................... 3 Industry Canada ............................................... 3 Introduction to STARwatch ................................. 4 Overview ...................................................... 4 Getting started ............................................... 4 Hardware Components ....................................... 5 Band .......................................................... 5 Sensors .................................................... 5 Display .................................................... 7 Touch ...................................................... 7 Battery .................................................... 7 Dock .......................................................... 7 Charge-only use ............................................ 7 Charge and data connectivity use ........................... 7 Software .................................................. 8 Overview ...................................................... 8 Installation .................................................. 8 Device management ............................................. 8 Firmware updates ........................................... 9 Configuring a device for recording ......................... 9 Stopping a Recoding and Downloading data .................. 10 Data management .............................................. 13 Raw files ................................................. 13 Worksheets ................................................ 14 Creating worksheets ....................................... 14 Import & Export ........................................... 15 Deleting .................................................. 17 Worksheet editing ............................................ 18 Sleep scoring step 1: Sleep analysis for Active/Inactive epoch classification ...................... 19 Sleep scoring step 2: Identify In Bed Periods either manually or automatically ................................. 19 Sleep Statistics Reference ................................... 21 Sleep metrics for single in-bed intervals ................. 22 Daily sleep metrics ....................................... 24 Summary statistics ........................................ 25 References ............................................... 26 2016 Pulsar Informatics, Inc. Page 2 of 26 Important Information Important Information FCC This device complies 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. FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. Industry Canada This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following 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. Cet appareil est conforme aux normes dexemption de licence RSS dIndustry Canada. Son fonctionnement est soumis aux deux conditions suivantes : (1) cet appareil ne doit pas causer dinterfrence et (2) cet appareil doit accepter toute interfrence, notamment les interfrences qui peuvent affecter son fonctionnement. 2016 Pulsar Informatics, Inc. Page 3 of 26 Introduction to STARwatch Introduction to STARwatch Overview STARwatch is a professional sleep and activity tracking system that includes three components:
STARwatch Band Unobtrusive wrist-worn band with integrated motion, light, and wear-
detection sensors. STARwatch Dock USB docking station for charging the band batteries and providing connectivity to the STAR software. STAR Software Windows software application for configuring bands, and managing and analyzing data. Getting started The following steps will quickly get you started with your STARwatch system:
1. Download and install STAR software A link to download STAR software will have been provided to you by Pulsar after your purchase. Run the installation program on a computer that meets the minimum requirements. Start the software after installation is complete. 2. Connect a dock and band to your computer Plug a dock into a USB port on the computer you have installed the STAR software onto. Place a band onto the dock, and you will see a device appear in the Device tab in the software. 3. Start a recording Enter a subject name into the device recording screen in the STAR software, and click the Start Recording button. Remove the band from the dock and start wearing it. 4. Review the User Manual Learn about the complete details on the operation and maintenance of the hardware components and use of the software for device configuration, data management, and sleep scoring analysis. 2016 Pulsar Informatics, Inc. Page 4 of 26 Hardware Components Hardware Components Band Sensors Light The STARwatch has a four channel, RGB-W (Red, Green, Blue, & White) light sensor. The lens is on the front face of the band and receives ambient light. The Red, Green, and Blue channels measure irradiance, the light power, within each of the spectral ranges. The white channel measures overall illuminance, which is an indicator of human brightness perception. Light channel Red Irradiance Description Red power level in uW/cm^2 Green Irradiance Green power level in uW/cm^2 Blue Irradiance Blue power level in uW/cm^2 White Illuminance White level in lux The approximate relative sensitivity curves for the Red, Green, and Blue channels are shown in the figure below. 2016 Pulsar Informatics, Inc. Page 5 of 26 Hardware Components On-wrist The band detects whether it is being worn using a proximity sensor embedded on the inside surface of the band. When the band is being worn, the presence of the wrist close to the band is measured. The on-wrist sensor uses a capacitive proximity field and does not require the wrist to be in direct contact with the surface of the band, but if the band is worn loosely it may result in intermittent spuriuous off-wrist measurements. Accelerometer A three axis accelerometer measures motion of the band along the X, Y, and Z axes as shown in the figure below. The raw acceleration signals are measured at a sampling rate of 50Hz or above, and later processed to generate derived activity count metrics. The sampling rate and range setting of the accelerometer are selected at the time a recording is started. The default settings are 50Hz, and 4g. Setting Values Description Frequency 50Hz, 100Hz, 200Hz Rate at which raw acceleration values are measured. Higher rates reduce battery life. 2016 Pulsar Informatics, Inc. Page 6 of 26 Hardware Components Range 4g, 8g, 16g Display Maximum acceleration range. Higher ranges allows faster movements to be detected. Lower ranges provider greater sensitivity for slower movements. The STARwatch band has an illuminated display that provides status indicators to both device administrators and subjects. When the band is docked the display has a landscape orientation and off the dock it has a portrait orientation. Touch Users can toggle display modes of the STARwatch band using the touch interface on the front face. A long press on the face will awaken the screen. Subsequent short presses will toggle the display page. Battery Power is provided by an internally-sealed rechargeable Lithium-Ion battery. The battery charges when placed on the dock. Recharge time will vary based on the level of battery, but a full charge from empty to full will complete within 1.5h. A battery full indicator is shown on the band display, and within the software when a full charge has been achieved. Dock Charge-only use The dock can be used just to charge bands, by connecting the USB cable to any USB port that can provide power. The USB port may be a USB wall-adapter, a computer
(with or without the STAR software), or on a USB hub. Charge and data connectivity use When the docks USB cable is connected to a computer that is running the STAR software, it provides both battery charging and data connectivity. When a band is connected to the dock its battery will charge automatically if it is not full, and the band will appear in the STAR software. 2016 Pulsar Informatics, Inc. Page 7 of 26 Software Software Overview The STAR software is a Windows application that serves two purposes: a) communication with the STARwatch band devices, b) organization and analysis of the data. Installation Running the STAR software requires a computer that meets the following requirements:
Requirement Description Operating system Windows 7, 8, 8.1 RAM Disk space 4 GB 100GB recommended for initial use. Device management The Devices tab view has two panels: 1) a connected devices list that shows all bands currently connected to the computer, and 2) a device detail that shows information about any device that is selected in connected devices list. c 1. Connected devices list 2. Device detail 2016 Pulsar Informatics, Inc. Page 8 of 26 Software Firmware updates The STAR software automatically checks over the internet for new firmware updates that are available for the STARwatch. These updates contain performance enhancements or additional features and should always be updated if theyre available. In the device detail panel, the availability of an update is shown by an alert above the device ID:
c Apply an update If an update available alert is visible, follow these steps to apply an update:
1. Check that a good internet connection is available 2. Ensure the device is in Configure mode (data has been erased, and it is not currently recording) 3. Click on the Update Available alert 4. On the device information pop-up window, click Update Now 5. Wait for the firmware to complete the automatic update. Do not disconnect the device from the dock while the upload is in progress. Configuring a device for recording When a device is in ready state to start a new recording (data has been erased, and it is not currently recording), the Recording Configuration page will show in the device detail panel when the device is connected:
2016 Pulsar Informatics, Inc. Page 9 of 26 Software Set the subject identification, sensor configuration settings, and recording start time to the desired values then select Start recording to put the device into recording mode. Stopping a Recoding and Downloading data When a device that is recording is placed on the dock information about the devices current recording session is shown in the device detail panel. The device can be removed from the dock it will continue its recording session uninterrupted. To end the recording session, click the Stop recording button. 2016 Pulsar Informatics, Inc. Page 10 of 26 Software c The download screen will then show an option to Download Now or Skip and Erase. The Skip and Erase option will bypass the download step and permanently delete the data on the device. c 2016 Pulsar Informatics, Inc. Page 11 of 26 Software Initiating the Download process will show a download progress bar. Once the download is complete a new raw data file is available in the Data tab. 2016 Pulsar Informatics, Inc. Page 12 of 26 Software Data management The Data tab view has three panels: 1) Raw data file list with original downloaded data files, 2) Worksheets list with each of the epoch-sampled worksheets that have been created, and 3) detail view of the data file or worksheet that is selected. 2. Worksheets list 1. Raw file list 2. Raw file/worksheet detail Raw files Raw files contain the STARwatch sensor measurements at the full sampling rates that were selected during recording. The sampling rates may vary between channels, so the raw files contain data streams at variable sampling rates. Each time a download from a device is completed a new Raw file is created, and cannot be modified after it has been created. The fields in the raw files include the following:
Raw file field Off-Wrist Description Numeric value indicating wrist proximity. Values > 0 are off-wrist, values < 0 are on-wrist. White Light (lux) White light illuminance measurement Red Light (uW/cm^2) Red light irradiance measurement Green Light (uW/cm^2) Green light irradiance measurement Blue Light (uW/cm^2) Blue light irradiance measurement Accel X (g) Accel Y (g) Acceleration in the x-axis Acceleration in the y-axis 2016 Pulsar Informatics, Inc. Page 13 of 26 Software Accel Z (g) Acceleration in the z-axis Worksheets Worksheets are summary data files, in which all channels have been resampled into consistently sized epochs. The multi-axis, high-frequency motion data from the Raw files is aggregated into a single Activity Count field that is used as the input for actigraphy sleep scoring. The fields in the worksheets, and the epoch binning method is as follows:
Worksheet data field Description Off-Wrist White Light (lux) True or false value indicating wear or non-wear. Median value of all raw off-wrist measurements in the epoch Mean value of all raw white-light measurements in the epoch Red Light (uW/cm^2) Mean value of all raw red-light measurements in the epoch Green Light (uW/cm^2) Mean value of all raw green-light measurements in the epoch Blue Light (uW/cm^2) Mean value of all raw blue-light measurements in the epoch Activity Count Numeric value indicative of the overall level of motion during the epoch. Raw X, Y, Z acceleration values are filtered and integrated. Creating worksheets Worksheet from raw file Raw files contain the high resolution measurements that are processed to create new worksheet with fixed duration epochs. When creating a worksheet an epoch duration is selected, and the raw file measurements are aggregated into bins of the selected epoch duration. To process a raw data file into a new worksheet:
1) Select a raw data file 2) Click Create new worksheet button 3) Select a label, and epoch setting 2016 Pulsar Informatics, Inc. Page 14 of 26 Software Worksheet from another worksheet An existing worksheet can be duplicated to create a new worksheet. This approach does not require the associated Raw file, but does not allow the selection of a different epoch setting than the one used in the existing worksheet. Duplicating a worksheet will also copy over all in-bed and sleep estimates that have been added to the existing worksheet. To process a duplicate an existing worksheet:
1) Select a worksheet 2) Select the menu option Import, Export & Manage > Duplicate Import & Export STAR software provides various options for exporting data for analysis in other scientific computing applications, exporting summary reports, and archiving and transporting data. These options are found in the Import and Export options under the Import, Export & Manage menu. 2016 Pulsar Informatics, Inc. Page 15 of 26 Software Worksheet CSV Export A CSV (Comma Separated Values) worksheet export contains multiple sections of analytical data intended for detailed human review or for import into another scientific computing tool. The sections include:
Subject subject identification Recording Session session start and end times Device model and identification Recording Settings sensor configuration parameters set when recording started. Analysis Settings analysis parameters set when editing the worksheet InBed Interval Sleep Statistics summary statistics about the measurements during each contiguous in-bed interval Active Interval Statistics summary statistics about the measurements during each contiguous active interval Daily Interval Statistics summary statistics about the amount of time spent in each classification state grouped by day Off-Wrist Interval Statistics summary statistics about the measurements during each contiguous off-wrist interval Sleep Report sleep quality and quantity metrics for each day Eport Data complete list of values for each epoch in the data set Worksheet PDF Export A PDF worksheet export includes a visual raster plot for each day of data, and a summary sleep report statistics table. The PDF is convenient for quickly presenting or sharing data with others outside of the STAR software. Worksheet STARwatch (*.wstar) Export & Import The STARwatch Worksheet (*.wstar) file format is a compressed binary format used exclusively for archiving data or transporting data between two STAR software 2016 Pulsar Informatics, Inc. Page 16 of 26 Software applications. When you export a worksheet in this format you will create a *.wstar file. This file can be imported back into a STAR application. Common uses for the *.wstar Export/Import include exporting a worksheet so that it can be sent to another computer running the STAR application, and exporting a worksheet for archiving in a backup. Raw File CSV Export A CSV (Comma Separated Values) raw file export provides complete sensor measurements recorded by the device, and is designed for machine-readability. The sections include:
Subject subject identification Recording Session session start and end times Device model and identification Recording Settings sensor configuration parameters set when recording started. Analysis Settings analysis parameters set when editing the worksheet Raw Data complete list of measurement values for each sample in the data set. Fields that are sampled more infrequently that others are shown with blank values when no measurement was taken at a particular time instant. Raw File Export and Import options The STARwatch Raw (*.rstar) file format is a compressed binary format used exclusively for archiving data or transporting data between two STAR software applications. When you export a raw file in this format you will create a *.rstar file. This file can be imported back into a STAR application. One use for the *.rstar Export/Import is to export a raw file so that it can be sent to another computer running the STAR application (e.g. field study sending data to a central repository) The *.rstar Export/Import may also be used to archive data into a long-term backup. As the number of raw files increases, the amount of disk space occupied by the Raw files may grow substantially. If the Raw file data is not going to be accessed frequently again, it may be helpful to export the Raw files into separate storage, and delete the Raw Files in the the application. Deleting A worksheet can be deleted by selecting one in the Worksheet list, and then selectiong the menu item Import, Export & Managed > Delete. A Raw File can also be deleted, however to reduce the chance of accidental data deletion there is no menu command. To delete a Raw File, select a Raw File in the 2016 Pulsar Informatics, Inc. Page 17 of 26 Software Raw File List and then press the <DEL> button. A commond prompt will ask for a confirmation before permanently deleting the data. Worksheet editing The worksheet editing view allows detailed navigation of the timines, reviews of summary statistics, and editing of sleep scoring. The view includes: 1) View mode selection options, 2) Worksheet visualization, and 3) Sleep score configuration. 1. View mode selection 2. Worksheet visualization (raster, timeline or summary) The view modes supported in the Worksheet editor view are:
3. Sleep score configuration 2016 Pulsar Informatics, Inc. Page 18 of 26 Software Raster twenty-four hour timelines stacked vertically, useful for viewing day-by-day patterns Timeline horizontal scrolling timeline, allowing zooming into detailed timeline segments Summary numeric sleep and activity statistics for the data set Sleep scoring a worksheet classifies segments of time in which the subject was Active, or In-Bed, and for the In-Bed intervals estimates the times the subject was actually asleep. Scoring is performed as a two step process: 1) Run a sleep analysis to classify each epoch as ACTIVE or INACTIVE, 2) Determine In-Bed intervals and classify epochs within the In-Bed intervals as either Sleep or Wake Sleep scoring step 1: Sleep analysis for Active/Inactive epoch classification In the top section of the Sleep Score Configuration panel, select one of the two algorithms that are available as options for the sleep analysis: Sadeh1 or Cole2. Both generally apply a window function to the activity count values, then compare the resulting values to a threshold to classify each epoch as Active or Inactive. The Active/Inactive classification of each epoch is not shown immediately in the Worksheet visualizer, but can be viewed in a CSV export. Sleep scoring step 2: Identify In Bed Periods either manually or automatically The In-Bed period identification can be performed with a combination of automated algorithms and/or manual edits. The second section in the Sleep Score Configuration panel presents two options for identifying In-Bed periods: Manual or Auto-fill. Selecting Auto-Fill triggers an in-bed detection algorithm to run over the entire timeline, whereas Manual indicates that in-bed intervals have been manually edited on the timeline. Once an In-Bed interval is created, the epochs within the In-Bed interval are classified Wake/Sleep based on the Active/Inactive classification from Step 1. 2016 Pulsar Informatics, Inc. Page 19 of 26 Software Auto fill In Bed algorithms The Auto fill in-bed detection algorithms use the Active/Inactive classification calculated in the Step 1 as an input. The default Auto fill setting is the Tudor-Locke3 algorithm. Alternatively you can create a custom set of parameters by selecting Custom then adjusting the settings as desired:
The parameters in the custom in bed algorithm are the following:
Raw file field Description In-Bed Onset Trigger (min) Number of consecutive Inactive epochs that mark the possible beginning of an In Bed period. The In Bed period would start at the first epoch of the consecutive Inactive epochs Min In-Bed Duration (min) Minimum duration that an In Bed period must last without a Wake period starting. Wake Onset Trigger (min) Number of consecutive Active epochs that mark the possible beginning of a Wake period. The Wake period would start at the first epoch of the consecutive Active epochs Min In-Bed Duration (min) Minimum duration that a Wake period must last without an In-Bed period starting. 2016 Pulsar Informatics, Inc. Page 20 of 26 Software Manually editing In Bed periods In Bed intervals can be manually edited in either the Raster or Timeline view mode. If the In-Bed settings are set to Auto fill, any manual edits will cause the mode to switch to Manual. There are three ways of editing the In-Bed intervals:
DELETE an In Bed period by hovering over an interval and clicking the X symbol in the upper right corner. ADJUST START or END of an In Bed period by clicking and dragging an edge. CREATE a new In Bed period by clicking once on the timeline barto mark a first edge, and clicking a second time to mark the second edge. Sleep Statistics Reference Worksheets export into PDF or CSV formats and include comprehensive sleep statistics based on the In-Bed periods and Sleep/Wake epoch classifications. A reference to the methods and interpretation of the sleep statistic measures is provided below. 2016 Pulsar Informatics, Inc. Page 21 of 26 Software Sleep metrics for single in-bed intervals Each epoch within an in bed interval is scored as either Wake or Sleep. Contiguous epochs of the same type are grouped to create Wake and Sleep periods. Metrics for each in bed interval are calculated based on the Wake and Sleep periods as shown in Figure 1. Sleep and wake metrics for an in bed interval Sleep and wake metrics for an in bed interval with an unknown period due to the off wrist sensor Sleep Onset Latency The length of time between the first attempt to get to sleep and sleep onset. SleepOnsetLatency = Sum of all epochs scored as wake from the start of the in bed period up to the start of the first epoch scored as Sleep. 2016 Pulsar Informatics, Inc. Page 22 of 26 Software Wake after sleep period (WASP) The length of time spent awake in bed between the final awakening and out of bed. Unknown epochs are not included in the WASP. WASP = Sum of all epochs scored as wake between the end of the final sleep epoch and the end of the in bed period. Wake after sleep onset (WASO) The total length of time spent awake in bed between sleep onset and the final awakening. WASO = Sum of all epochs scored as wake that are not classified as SleepLatency or WASP. Unknown Time The total length of time within the in bed period in which the data in excluded form analysis and the state is unknown. Total Sleep Time (TST) The total length of time asleep while in bed, calculated by the sum of all sleep periods. Time In Bed (TIB) The length of time in bed, as calculated. TST = Sum of all epochs scored as wake within the InBed interval. TIB = Difference between the Out of Bed time and In Bed time. Sleep Efficiency The percentage of time spent asleep while in bed. Sleep efficiency% = TST/(TIB Unknown) * 100. Awakenings The total number of wake periods that interrupted sleep periods, excluding the final awakening. Avg. Awakening The average duration of all the wake periods that interrupted sleep periods, excluding the final awakening. Bed time The time of the start of the in bed interval. The In Bed time. Get Up time The time at which the bed interval ended. The Out of bed time. The following are some equality conditions that will hold for these variables:
Total time awake in bed = Sleep Latency + WASO + WASP TIB = SleepLatency + WASO + WASP + TST = Unknown 2016 Pulsar Informatics, Inc. Page 23 of 26 Software Daily sleep metrics For the purpose of visualizing sleep patterns, and calculating daily metrics, a 24-hour day is defined as a 24-hour period starting at a specified hour. The day corresponding to a given date is defined as the period from the Day Start Time on the given date, to the Day Start Time of the next date. For example, with a Day Start Time of 8:00am, the day corresponding to Aug 17 spans from Aug 17, 8:00am to Aug 18, 8:00am, as shown in Figure 2. Daily sleep metrics are calculated based on the set of In Bed Intervals associated with each day. Each interval is associated to the day in which the In Bed interval starts. The interval associations corresponding to Figure 2 are listed in Table 1. Example in-bed intervals on a 24-hour raster plot with a Day Start Time of 8:00am Example association of In-bed intervals to days. Day Aug 17 Aug 18 Aug 19 The daily metrics are calculated as follows:
Associated intervals A B, C D Sleep Onset Latency The sum of sleep onset latency for all intervals associated with the day. A value of NaN if there are no intervals. Wake after sleep onset (WASO) The sum of WASO for all intervals associated with the day. A value of NaN if there are no intervals. Wake after sleep period (WASP) The sum of WASP for all intervals associated with the day. A value of NaN if there are no intervals. Total Sleep Time (TST) The sum of TST for all intervals associated with the day. A value of 0 if there are no intervals. 2016 Pulsar Informatics, Inc. Page 24 of 26 Software Time In Bed (TIB) The sum of TIB for all intervals associated with the day. A value of 0 if there are no intervals. Sleep Efficiency The DailyTST/(DailyTIB DailyUnknown) * 100. A value of NaN if there are no intervals. Awakenings The sum of awakenings for all intervals associated with the day. A value of NaN if there are no intervals. Avg. Awakenings The average duration of all awakenings for all intervals associated with the day. A value of NaN if there are no intervals. Bed time The In Bed time of the longest interval associated with the day. In the case where the longest interval occurs in two or more intervals having the same length, the interval occurring first is used. A value of NaN if there are no intervals. Get Up time The Out of bed time of the longest interval associated with the day. In the case where the longest interval occurs in two or more intervals having the same length, the interval occurring first is used. A value of NaN if there are no intervals. Note that the method of grouping intervals into days based on the start time makes it possible for values for some of the metrics to have values greater than 24h. When a day has no sleep intervals, the metrics will either have a value of 0, or be treated as not a number (NaN). Summary statistics Summary statistics are calculated for the Min, Average, and Max values of the daily metrics over an entire worksheet data set. The summary values are calculated based on the set of values for each daily metric, and are not recalculated using each interval. In cases where the daily metric has a NaN value, it is ignored in the statistical operation. The Min, Average, and Max statistics for metrics that have time-of-day values (Bed Time and Get Up Time) are calculated based on a linear scale starting from the Day Start Time. 2016 Pulsar Informatics, Inc. Page 25 of 26 References References 1 Sadeh, A., K.M. Sharkey, and M.A. Carskadon, Activity-based sleep-wake identification: an empirical test of methodological issues. Sleep, 1994. 17(3): p. 201-207. 2 Cole, R.J., et al., Automatic sleep/wake identification from wrist activity. Sleep, 1992. 15(5): p. 461-469. 3 Tudor-Locke, C., et al., Fully automated waist-worn accelerometer algorithm for detecting childrens sleep-period time separate from 24-h physical activity or sedentary behaviors. Applied Physiology, Nutrition, and Metabolism, 2013. 39(1): p. 53-57. 2016 Pulsar Informatics, Inc. Page 26 of 26