BioDashboard® Instructions for Use Ver.11

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Table of Contents

1. Overview

  • BioDashboard (the Device) is intended to display and visualize physiological and medical data and log assessments.
  • The Device displays data and notifies healthcare professionals when physiological data fall outside clinician-specified parameters.
  • The data from the Device are intended as an aid to diagnosis, diseases management, and treatment.
  • Healthcare professionals are the intended operators of this device.
  • The Device is intended for use on patients who are 18 years of age or older.
  • The Device is not intended for critical care.
  • The Device has the ability to allow the clinician to configure the parameters for notifications.

2. Intended Use Statement

Please refer to the intended use for our BioIntelliSense Devices:
https://www.biointellisense.com/support

3. Warnings and Precautions

  • Recommendations provided by BioDashboard are adjunctive (supporting). Do not solely or primarily rely on the BioDashboard to prevent, diagnose, or treat a disease or condition.
  • Do not use accessories, detachable parts or materials other than those described.

4. Use Instructions

4.1. Login

To begin using the BioDashboard proceed to https://biodashboard.net which will display the login screen similar to that shown below.

Picture 404461342

Enter your username and password to log in to BioDashboard. The following options are available:

  • Email
    Provide your email/username for your BioDashboard account.
  • Password
    Provide your password for your BioDashboard account.
  • Log In Button Graphic 4
    After entering your username and password, click this button to login.
  • Forgot Password ButtonGraphic 5
    If you have forgotten your password, you can click this button to reset your password.
  • Sign in with Auth0 Graphic 6
    Click this button to use Auth0 to log in.

IMPORTANT NOTE: The options that are displayed on the login screen are dependent on your organization’s configuration.

4.2. Multi-Patient View

Once logged into BioDashboard, the Multi-Patient View is displayed similar to that shown below. Click the Census Button Graphic 7 / Graphic 8 in the banner on the left side of the screen to access the Multi-Patient View at any time:

Picture 1

The Multi-Patient View displays summary information for all patients within the selected unit(s). The following options are available:

  • Patient Cell
    View summary information for an individual patient. Click a patient cell to display the Clinical View (described below) for that patient.
    • Patient room number
    • Patient name
    • Last data
      Displays the time since the last data was received by a BioIntelliSense wearable monitoring device.
    • Wrench IconPicture 1
      Indicates notification settings have been changed for the specific patient.
    • Active Clinical Notification Button Graphic 9
      Indicates an active clinical notification. Click this button to view the Clinical View (described below).
    • Active Non-Clinical Notification Button Graphic 10
      Indicates an active non-clinical notification. Click this button to view the Clinical View (described below).
    • Clinical Notification Review Button Graphic 11
      Indicates a clinical notification for a specific patient that needs review. Click this button to access the Clinical View (described below) and enter an assessment for any notifications that need review.
      IMPORTANT NOTE: Notes and Notification Reviews must be enabled in Settings to view this icon.
    • Non-Clinical Notification Review Button Graphic 12
      Indicates a non-clinical notification for a specific patient that needs review. Click this button to access the Clinical View (described below) and enter an assessment for any notifications that need review.
      IMPORTANT NOTE: Notes and Notification Reviews must be enabled in Settings to view this icon.
    • Move Patient Button Graphic 13
      Click this button to access a dropdown menu to move the selected patient to a new category/color within a care unit in the Multi-Patient View, based on the configuration of the user. The default options are Not Set, Monitor, Telemetry, Floor, Home, and SNF.
      IMPORTANT NOTE: User must have the PHI permission to move patients.
    • Patient Interactions Notification Button Graphic 15
      Indicates there are no documented patient interactions for this patient. Click this button to access the Reimbursement View (described below).
      IMPORTANT NOTE: “Enable RPM reimbursement icons in multi-patient view” must be enabled in Settings to view this icon.
    • Time Spent Notification Button Graphic 17
      Indicates less than 10 minutes of time spent interacting with the patient. Click this button to access the Reimbursement View (described below).
      IMPORTANT NOTE: “Enable RPM reimbursement icons in multi-patient view” must be enabled in Settings to view this icon.
    • Vitals Data Notification Button Graphic 16
      Indicates patient has less than 2 days of vitals data collection. Click this button to access the Reimbursement View (described below).
      IMPORTANT NOTE: “Enable RPM reimbursement icons in multi-patient view” must be enabled in Settings to view this icon.
    • Patient Heart Rate
      Displays the most current resting heart rate for the patient from the BioIntelliSense wearable monitoring device. Yellow highlight indicates abnormally high level or low level. See Color Limits Tab in Help Menu for definitions.
    • Patient Respiratory Rate
      Displays the most current resting respiratory rate for the patient from the BioIntelliSense wearable monitoring device. Yellow highlight indicates abnormally high level or low level. See Color Limits Tab in Help Menu for definitions.
  • Add Patient Button Graphic 18
    Click this button to access the Patient Registration Form (described below) to add a new patient to the current Unit.
    IMPORTANT NOTE: PHI display must be enabled in the Settings to view this button, and it will only be available if configured for your organization.
  • Unit Dropdown Menu
    Select the care unit(s) to display by selecting the corresponding checkbox(es). Click the “Apply” Button Graphic 19 to show the selected censuses. Click the “Select All” Button Graphic 20 to select all censuses. Click the “Clear” Button Graphic 21 to clear selections.
  • Filter Dropdown Menu
    Select to display devices that have displayed data in the last 24 hours or 7 days, have notifications that need review, have modified alert settings, recently viewed patients (i.e. last 20 patients recently viewed), have active notification icons, have pinned notes, have reimbursement icons, and/or have been flagged.
  • Order By Dropdown Menu
    Choose to sort patients by notifications, patient last name, Bio ID, length of stay, patient age, room, and patient ID/MRN.
    IMPORTANT NOTE: Patients with active notifications and notifications that need review are always displayed at the top of multi-patient view. PHI display must be enabled in the Settings to sort by notifications that need review.
  • Search Text Box
    Search for specific text to find patients. Use the optional search parameters to help narrow down the search. All or none of the parameters can be selected:
    • Room Number
    • Patient MRN
    • Patient Name
    • Bio ID

drawing

  • Census Button Graphic 22 / Graphic 23
    Click this button in the banner on the left side of the screen to access the Multi-Patient View.
  • About Menu Button Graphic 24 / Graphic 25
    Click this button in the banner on the left side of the screen to display the BioDashboard version number and other software identification information, as well as provides access to the BioDashboard Instructions for Use.
  • Help Menu Button Graphic 26 / Graphic 27
    Click this button in the banner on the left side of the screen to access the Help Menu (described below).
  • Settings Button Graphic 28 / Graphic 29
    Click this button in the banner on the left side of the screen to access the Settings Menu (described below).
  • Logout Button Graphic 30 / Graphic 31
    Click either of these buttons to logout.
  • Group by Category Slider Graphic 32
    Slide this toggle to enable or disable category features. Individual patients can be categorized by category in the Clinical View Settings Menu (described below).
  • Load Discharged Patients Slider Graphic 33
    Slide this toggle to show or hide discharged patients in the Multi-Patient View. Choose the number of past days of discharged patients to be displayed in the text box to the right of the slider.
  • Category Buttons
    Click a category button at the top of the Multi-Patient View screen to only show patients within that specific category. The default options are Not Set, Monitor, Telemetry, Floor, Home, and SNF.

4.3. List View

Click the List View Button Graphic 34 / Graphic 35 in the banner on the left side of the screen to access the List View similar at any time. Click on any row to navigate to the patient’s Clinical View. The following options are available:

Picture 1
  • Unit Dropdown Menu
    Select the care unit(s) to display by selecting the corresponding checkbox(es). Click the “Apply” Button Graphic 19 to show the selected censuses. Click the “Select All” Button Graphic 20 to select all censuses. Click the “Clear” Button Graphic 21 to clear selections.
  • Filter Dropdown Menu
    Select the patient(s) to display by selecting the desired checkboxes.
  • Default Views Dropdown Menu
    Select a default view to display. The following options are available.
    • Monitoring
    • Virtual Rounding
    • Central Nursing Station
    • Care Coordination
    • Home Monitoring
    • All
  • Print Graphic 36 Button
    Click this button to print a PDF of the current List View.
  • Export CSV Button Graphic 37
    Click this button to export a CSV of the current List View.
  • Configure Columns Button Graphic 38
    Click this button to customize the columns in List View. Choose the column(s) to be displayed by toggling the slider(s) Graphic 39 and the order they appear with the drag/drop icon(s) Graphic 40. Click the Apply Changes Button Graphic 41 to display the new custom view. To save the custom view, click the Default Views Dropdown Menu (described above) after creating a new custom view and click the Save Current View ButtonGraphic 42. This will prompt the user to choose a name for the custom view, which will then be made available for the user in the dropdown menu.
  • List View Data
    Click the arrow next to column to reverse the order the data are sorted by.
    • Patient Unit
      The unit the patient is located in.
    • Category
      The category/color the patient is assigned to in BioDashboard
      • Click on the move button (Graphic 43) to move the patient to a different category
    • Room
      The room the patient is located in.
    • Patient Last Name
    • Patient First Name
    • Patient MRN
      Patient specific identifier.
      • Hover over the MRN to copy the MRN to clipboard Graphic 44
    • Patient Bio ID
      Patient BioIntelliSense Device ID.
    • Duration
      Number of days a patient has been monitored.
    • Patient Config
      Purple wrench is displayed when patient configurations have been set.
    • Reimbursement
      Reimbursement icons are displayed when billing criteria has not yet been met.
    • Duration
      Number of days a patient has been monitored.
    • BioButton Status
      The latest status of the patient and assigned device.
      • Green: HR and RR coming in
      • Yellow: HR or RR missing for 2 hours
      • Orange: HR or RR missing for 4 hours
      • Purple: New BioButton scanned in last 2 hours
    • HR
      Current heart rate for patient.
    • RR
      Current respiratory rate for patient.
    • % On Body
      The percentage of time the device was detected as worn in the past 24 hours, based on the available offloaded data:
      • Green: > 80%
      • Yellow: < 80%
    • Clinical Notifications (24 h)
      The number of clinical notifications generated for a patient in the past 24 hours:
      • Green: None
      • Yellow: 1 notification
      • Orange: > 2 notifications
      • Gray: None and < 80% on body minutes available in the last 24 hours
      • IMPORTANT NOTE: Hover over the row to view the timestamps and notification types.
    • Active Clinical Notifications
      The total number of active clinical notifications (excluding BOT notifications).
    • Active Non-Clinical Notifications
      The total number of active technical notifications.
    • Clinical Notification Reviews
      The total number of clinical notifications to be reviewed (excluding BOT notifications).
    • Non-Clinical Notification Reviews
      The total number of technical notifications to be reviewed.
    • Activity (0-24h)
      The total number of medium and high activity minutes recorded in the past 24 hours:
      • Green: > 220 minutes
      • Yellow: 110-220 minutes
      • Orange: < 110 minutes
      • Gray: < 80% of activity minutes available in the last 24 hours
      • IMPORTANT NOTE: Hover over the row to view the breakdown of activity in low, medium and high minutes.
    • Activity (24-48h)
      The total number of medium and high activity minutes recorded between 24 and 48 hours ago:
      • Green: > 220 minutes
      • Yellow: 110-220 minutes
      • Orange: < 110 minutes
      • Gray: < 80% of activity minutes available between 24 and 48 hours ago.
      • IMPORTANT NOTE: Hover over the row to view the breakdown of activity in low, medium and high minutes.
    • Active Minutes Change
      The difference in active minutes between the most recent 24 hours (0-24 hours) and the previous period (24-48 hours).
      • Green: Positive change
      • Orange: Negative change
      • Grey: Zero change or N/A
    • Clinical Impact
      Add or view clinical impact entries.
      • Plus Button Graphic 46
        Click on this button within any of the patient rows to add a clinical impact. Select an entry category, associated notifications with the entry, and contextual information in the free text box. Select the flag patient checkbox for internal review. Then, select “Save Entry”.
        Image27
      • Note Button Graphic 47
        Click on this button in the Clinical Impact column to view previous entries that have been created.
        Picture 5

4.4. Clinical Impact Report View

Click the Clinical Impact Report Button Graphic 48 / Graphic 49 in the banner on the left side of the screen to generate Clinical Impact Reports at any time.

IMPORTANT NOTE: User must have the appropriate permission enabled to access the Clinical Impact Report.

Image32

The Clinical Impact Report outputs patients that were flagged by using the New Entry and Flag Patient Checkbox features in the Clinical View and Patient List View (described below). The following generation parameters are available:

  • Unit
    Select the desired Unit(s) to be included.
  • Time Zone
    Select the desired time zone for all data displayed.
  • Start Date
    Select the desired start date of the reporting period.
  • End Date
    Select the desired end date of the reporting period.
  • Full PHI Slider
    Slide this toggle to enable full PHI for the Clinical Impact Report. If not enabled, the non-PHI Clinical Impact Report will contain only de-identified patient data.
  • Generate Report Button Graphic 50
    Click this button to generate the Clinical Impact Report for the parameters selected above. Once the report is finished loading, click on either buttons below to export.
    • Export CSV Button Graphic 51
      Click this button to export a CSV file of the generated Clinical Impact Report.
      • The CSV export includes all flagged patients.
      • Print Button Graphic 52
        Click this button to print the generated Clinical Impact Report. The PDF is organized into several sections:
        • Table of Contents.
          Displays a table of contents for the Clinical Impact Report.
        • Overview by Facility and Unit.
          Displays table of number of entries by category for the selected organization(s), facility(ies), and/or unit(s).
        • Case Overviews.
          Displays a summary of all flagged patients. Content includes the entry category, entry details and notification linked to issue if applicable.
        • Case Details.
          Displays a summary of all flagged patients with at least one tagged clinical notification. Content includes the entry category, entry details, tagged notification(s), notification assessment details (i.e. assessment, action, reactions) and patient charts for heart rate, respiratory rate, activity, and skin temperature annotated to highlight all notifications that occurred during the time date range selected (see notification icon(s) on chart(s). Below the chart, each notification is further listed and described.
          • Notification Annotation Icon Graphic 53.
            Displayed with a vertical line overlaying the patient chart that annotates the time of each notification. Numbers listed after this icon denote more than one notification. Yellow icons indicate active notifications and gold icons indicate inactive notifications.
        • Clinical Notification Settings.
          Lists the parameters for triggering notifications at end of each good catch report.

4.5. Clinical View

When an individual patient cell, Notification Review Button Graphic 54 / Graphic 55, or the Clinical View Tab Graphic 57 are clicked in Multi-Patient View (described above), a Clinical View is displayed similar to that shown below. Clinical View displays detailed information for an individual patient and allows a user to view patient-specific notifications that need review, enter pinned notes, and view notification history, as well as add new issues for assessment. The following options are available:

IMPORTANT NOTE: Notes and Notification Reviews must be enabled in the Settings to access Notification Review features. Notification Reviews features can also be hidden or displayed by using the collapse Graphic 58 or expand Graphic 60 buttons, respectively.

Picture 1
  • Patient Name/Navigation Bar
    Located at the top of the Clinical View, the Patient Name/Navigation Bar displays the following options:
    • Patient Name
      Name of patient.
    • Patient MRN
      Patient specific identifier.
    • Census
      The census the patient is located in.
    • Edit Patient Button Graphic 61
      Click this button to access the Edit Patient Registration Form (described below) to edit patient details. This form can be used to enter a new Bio ID to use a new BioButton with the selected patient and/or update other patient details.
      IMPORTANT NOTE: PHI display must be enabled in the Settings to view this button, and it will only be available if configured for your organization.
    • Settings Button Graphic 62
      Click this button to the left of the patient to access the Clinical View Settings Menu (described below).
    • Wrench Icon Graphic 63
      Indicates notification settings have been changed for the specific patient.
    • Clinical View Tab Graphic 64
      Click the Clinical View Tab to access the Clinical View.
    • Reimbursement View Tab Graphic 65
      Click the Reimbursement View Tab to access the Reimbursement View (described below).
      IMPORTANT NOTE: This will only be visible if configured for your organization.
    • Device Management View Tab Graphic 66
      Click the Device Management View Tab to access the Device Management View (described below).
    • Patient Encounters
      Displays date(s) of patient visit(s) and associated Bio IDs for each visit. Click the dropdown menu to display all encounters (if applicable).
      • In Facility Icon Graphic 67
        Indicates an in-facility patient visit.
      • At Home Icon Graphic 68
        Indicates an at-home patient visit.
  • Patient Details
    Displays the following details associated with the selected patient.
    IMPORTANT NOTE: Some details may not be listed or different depending on your configuration.
    • Room
      The room the patient is located in.
    • Bio ID
      Patient BioIntelliSense Device ID.
    • Sex
      Patient Sex
    • Date of Birth (Age)
      Patient date of birth and age.
    • Height
      Patient Height
    • Weight
      Patient Weight
    • Date of Activation
      Date of patient BioIntelliSense Device activation.
    • Duration
      Number of days a patient has been monitored.
    • Diagnosis
      Patient diagnosis.
    • Procedure
      Patient procedures.
  • Active Notifications
    Active notifications are listed. Clinical notifications are indicated by Graphic 69 and listed in yellow text. Non-clinical notifications are indicated by Graphic 70and listed in black text. Counts of the number of active clinical Graphic 71 and non-clinical notifications Graphic 72 are listed at the top of this section.
  • Body Panel/History Toggle ButtonsGraphic 73
    Click Body Panel Button to display patient health data. Click History Button to display the History List (described below).
  • Body Panel:
    • Patient Heart and Lung Icons
      The organs displayed in the image move at the rate of the patient’s most current vital signs from BioIntelliSense device. Green color indicates normal level and yellow indicates abnormally low or high level. Blue color indicates no data are available. See Color Limits Tab in Help Menu for definitions.
    • Thermometer Icon
      The thermometer icon displays the current skin temperature for a specific patient. Green color indicates normal level and yellow indicates abnormally low or high level. Blue color indicates no data are available. See Color Limits Tab in Help Menu for definitions.
  • Patient Vital Signs and Biometric Graphs
    Click a timescale button to display the following graphs over different timescales. The options are 12HR, 24HR, 3D, 7D, 30D, and Custom.
    • Heart Rate at Rest
      Line graph of resting heart rate over time in bpm.
    • Respiratory Rate at Rest
      Line graph of resting respiratory rate over time in rpm.
    • Skin Temperature
      Line graph of skin temperature over time in degrees Celsius (ºC).
    • Sleep
      Bar graph of sleep over time in minutes per hour.
    • Activity
      Bar graph of physical activity levels over time in minutes per hour, summarized as low, medium, and high activity.
    • Degree of Incline While Sleeping
      Bar graph showing the average degree of incline angle while sleeping each day.
    • Body Position
      Bar graph of time in different body positions in minutes per hour, summarized as supine, prone, upright, lying right, lying left, and unknown.
    • Steps
      Bar graph of steps over time, summarized as steps per hour.
    • Step Symmetry
      Dot plot of step symmetry over time, summarized each hour.
    • Step Strength
      Dot plot of step strength of right and left feet over time, summarized each hour.
    • On/Off Body
      Bar graph of time wearing BioIntelliSense device in minutes per hour.
      IMPORTANT NOTE: Some of the graphs listed above may not be displayed depending on your configuration.
    • Notification Annotation IconGraphic 69
      Displayed with a vertical line overlaying the patient chart that annotates the time of each notification. Numbers listed after this icon denote more than one notification. Yellow icons indicate active notifications and opaque yellow icons indicate inactive notifications.
    • Heart Rate and Respiratory Rate Graph Settings
      Click the Gear Icon Graphic 74 at the top right of the heart rate or respiratory rate graph panels to display the graph settings menu. The following options are available:
      • Line Graph Slider
        Slide this toggle to turn on line graphs. When enabled, the data points will be connected with lines.
      • Trend Line Slider
        Slide this toggle to turn on trend lines. When enabled, a trend line of the moving average will be displayed to smooth out fluctuations in data points and help identify trends. By default, the trend line is enabled.
      • IMPORTANT NOTE: Disabling both toggles will display a scatterplot. Some of the graphs listed above may not be displayed depending on your configuration.
    • Activity Graph Settings
      Click the Gear Icon Graphic 74 at the top right of the activity graph panel to display the graph settings menu. The following options are available:
      • Routine Activity Slider
        Slide this toggle to enable display of routine activity in the activity graph.
      • Exercise Slider
        Slide this toggle to enable display of exercise activity in the activity graph.
      • At Rest Slider
        Slide this toggle to enable display of at rest activity on the activity graph.
      • By default, display of exercise and routine activity is enabled and display of at rest activity is disabled.
  • History List
    The History List displays the patient history log. The following options are available to display from the Filters Dropdown Menu Graphic 75:
    • View All
      Select from the dropdown menu to view all items in the History List.
    • Pinned Note Updates
      Select from the dropdown menu to view Pinned Notes Updates in the History List.
    • Notifications
      Select from the dropdown menu to view Notifications in the History List.
    • Entries
      Select from the dropdown menu to view manual user entries in the History List.
    • Monitoring Status Updates
      Select from the dropdown menu to view Monitoring Status Updates in the History List.
  • Census Back Button Graphic 76
    Click this button to stop monitoring the patient for billing and navigate back to the Multi-Patient View.
  • Pinned Note Text Box
    Enter a pinned note for the patient by entering text in the box and clicking the Save Note Button Graphic 77. This will also enter the pinned note information in the History List on the left side of the screen. Click the Cancel Button Graphic 78 to discard the current Pinned Note.
  • Notification Review/New Entry Toggle Graphic 79
    Use this toggle to select between Notification Review and New Entry options (described below).
  • Notification Review Button
    Click the Notification Review Button Graphic 80 to display the Notification Review. Use the arrows Graphic 81 to select a notification that requires review. Selecting a notification also changes the timescale of the charts to show the associated notification annotation if “Enable notifications navigation in patient charts” is toggled in Settings Menu (described below). The following options are available:
    • Assessment Dropdown Menu
      Select an option from the dropdown menu to log the assessment for the current notification.
    • Assessment Details Text Box
      Add additional details about the assessment for the current notification.
    • Action Dropdown Menu
      Select an option from the dropdown menu to log the action for the current notification.
    • Action Details Text Box
      Add additional details about actions for the current notification.
    • Reaction Dropdown Menu
      Select an option from the dropdown menu to log the reaction for the current notification.
    • Reaction Details Text Box
      Add additional details about reactions for the current notification.
    • Save Assessment Button Graphic 82
      Click this button to save the current assessment for the notification review. This will also log the assessment in the History List on the left side of the screen, remove the notification from the Notification Review, and remove the Notification Review Icon Graphic 83 / Graphic 84 from the Multi-Patient View, unless other current notifications still require review.
    • Not a Problem Button Picture 1
      Click this button to indicate that the current notification is not a problem. This will also log the assessment in the History List on the left side of the screen, remove the notification from the Notification Review, and remove the Notification Review Icon Graphic 83 / Graphic 84 from the Multi-Patient View, unless other current notifications still require review.
      IMPORTANT NOTE: If the customer is configured to have BioIntelliSense dismiss notification reviews based on recent data, those dismissed notifications will still appear in the history. In these cases, the User will be listed as ‘BioDashboard’.
  • New Entry
    Use the Notification Review and New Entry toggle to view the New Entry panel shown below. This option allows a user to enter a new, unlisted entry in the History List. The following options are available:
    Image67
    • Select Entry Category Dropdown Menu
      Select an option from dropdown menu to categorize the new entry.
    • New Entry Details Text Box
      Add details about the new entry in the text box.
    • Notifications Dropdown Menu
      Select a notification(s) to associate with the entry.
    • Flag Patient Checkbox
      Check this box to flag this entry to be displayed in the Clinical Impact Report.
    • Save Entry Button Graphic 85
      Click this Button to save the new entry. This will log the new entry in the History List on the left side of the screen.
  • Export BioReport Button Graphic 86
    Click this button to generate a PDF report of the currently selected patient’s vital signs and biometrics. Click “Save” in your web browser to download the report when prompted.

4.6. Reimbursement View

When a user clicks a Reimbursement Icon Graphic 87 / Graphic 88 / Graphic 89 in Multi-Patient View or the Reimbursement View Tab Graphic 90 in Clinical View or Device Management View, a Reimbursement View is displayed similar to that shown below. Reimbursement View allows a user to review notifications and reports for Remote Patient Monitoring Reimbursement as well as review and edit time tracking logs. The following options are available:

Picture 1
  • Patient Details
    Displays details associated with the selected patient.
  • Vitals Data Tracking
    • Days w/ Data
      Lists the number of days with at least one valid data point for the following vital signs when the patient is in the at-home care setting:
      • Heart rate
      • Respiratory rate
    • Calendar Icon
      Displays a count of the number of days vitals data has been collected within 30 calendar days.
    • 30-Day Window
      Displays the date range for the 30-day window of vitals data collection.
    • Vitals Data Collection Time Chart
      Displays a visual indication for when vitals data collection tracking codes are met. The following codes are displayed:
      • CPT 99445
        2–15 days of physiologic data.
      • CPT 99454
        Minimum 16 days of physiologic data.
  • Report Log
    The Report Log displays the following details for applicable service reports:
    • Date
      The date the report was generated.
    • Report Type
      Time Tracking or RPM Vitals.
    • Date of Service
      The date that the service requirements were met.
      • For Vitals Data, this is the day where a minimum of 10 minutes of time tracking and at least 1 documented patient interaction were recorded.
      • For Time Tracking, this is the day that at least 16 days of vitals data was collected, or the date at least 2 days of vitals data was collected, if less than 16 days of vitals data was collected.
    • CPT Codes
      The recommended CPT codes to bill based on data collected by the BioButton device for at-home monitoring.
    • Export Report Button Graphic 91
      Click this button to preview and download a report locally.
    • Report Types Filter Dropdown Menu
      Select the report types to display in the Report Log. The following options are available:
      • Vitals Data
      • Time Tracking
    • Time Range Dropdown Menu
      Select the time range to display in the Report Log. The following options are available:
      • Current Month
      • Last Month
      • Last 6 Months
      • Last Year
      • YTD
      • All
  • Time Tracking Log
    The Time Tracking Log displays the following details for each patient interaction:
    • Treatment Management Time Chart
      Displays a visual indication for when time tracking codes are met. The following codes are displayed:
      • CPT 99470
        10–19 minutes of documented time with at least one patient documented interaction.
      • CPT 99457
        Minimum 20 minutes of documented time with at least one patient documented interaction.
      • CPT 99458
        Add-on to CPT 99457. Additional 20 minutes of documented time.
    • Date/Time
      Date of interaction.
    • Total Time This Month
      The total number of minutes spent with the patient within a calendar month period.
    • Patient Communications This Month
      The total number of recorded patient interactions for the patient within a calendar month period.
    • Categories Dropdown Menu
      The category of interaction. The following options are available:
      • Data Review
      • Care Team Communication
      • Patient Communication
      • Care Planning
    • User
      The user that interacted with the patient.
    • Notes
      Optional notes about the interaction.
    • Action
      The following options are available:
      • Edit Interaction Button Graphic 92
        Click this button to manually edit the interaction.
      • Remove Interaction Button Graphic 93
        Click this button to remove the interaction.
    • Add Log ButtonGraphic 94
      Click this button to manually enter an interaction with the patient.

4.7. Device Management View

When a user clicks the Device Management View Tab Graphic 95, a Device Management View is displayed similar to that shown below. Device Management View allows a user to add, replace, and discontinue BioIntelliSense devices. The following options are available:

IMPORTANT NOTE: Display PHI must be enabled in the Settings to access these features. Some of the fields shown above may not be displayed or may be different depending on your configuration.

Image79
  • Add Device Button Graphic 96
    Click this button to add a new device for the selected patient. Manually enter the Bio ID of the new BioIntelliSense Device in the box or follow the onscreen instructions to scan the device barcode.
  • Replace Buttons Graphic 97 / Graphic 98
    Select a device(s) using the checkbox and then click this button to replace the selected device(s). Manually enter the Bio ID of the new BioIntelliSense Device in the box or follow the onscreen instructions to scan the device barcode.
  • Discontinue Buttons Graphic 99 / Graphic 100
    Select a device(s) using the checkbox and then click this button to discontinue patient monitoring for the selected device(s). This will also move the patient to the Discharged Category. A reason for device discontinuation must be selected. Additional notes can also optionally be added in the box.

4.8. Settings Menus

  1. Settings Menu
    Clicking the Settings Button Graphic 101 / Graphic 102 in the banner on the left side of the screen allows configuration of various options that apply to all patients and displays the settings menu shown below. The following options are available:
    • General Preferences:
      • Theme Mode
        Choose to toggle “Dark mode” or “Light mode” display modes.
    • Clinical View Settings:
      • Show PHI Slider
        Slide this toggle to turn PHI display on or off.
      • Show Notes and Notification Reviews Slider
        Slide this toggle to allow access to Notification Review features in the Clinical View. This enables Notification Review, Enter Issue, Pinned Notes, and Notes History features (described in Clinical View above).
      • Enable RPM reimbursement icons in multi-patient view Slider
        Slide this toggle to allow access to Reimbursement View (described in Reimbursement View above).
      • Enable Patient Review Carousel Slider
        Slide this toggle to enable navigation to the next patient that has an outstanding notification review when currently viewing a patient clinical view. Click on “Next Patient” arrows to navigate to the next patient in the bottom center of the application. This menu only appears when hovered over with mouse cursor. The order of the patients in the carousel reflects the order of the patients in the multi-patient view, following the sort by and filters being applied. PHI and Notes and Notification Reviews must be enabled to use this feature.
      • Show notifications in patient charts
        Slide this toggle to view clinical notifications in the patient charts.
      • Enable notifications navigation in patient charts
        Slide this toggle to enable the automatic adjustment of patient chart views after clicking on an active notification or navigating to the next notification to be reviewed in the clinical view.
    • Units and Date/Time Formats:
      • Temperature Unit
        Choose to toggle temperature display as Celsius or Fahrenheit.
      • Date Format Dropdown Menu
        Select the Date format from the dropdown menu.
      • Day/Month Format Dropdown Menu
        Select the Day/Month format from the dropdown menu.
      • Time Format Dropdown Menu
        Select the time format from the dropdown menu.
    • Advanced Settings
      Use the expand arrow Graphic 103 to display the following advanced options:
      • Enable Client Side Caching
        Helps improve performance by securely caching census data for up to two minutes.
      • Improve Patient Graph Performance
        Helps improve performance by reducing datapoint update frequency while using the Patient Graphs.

        Clinical View Settings Menu
        Clicking the Settings Button Graphic 104 near the patient name in Clinical View allows configuration of various options that apply only to an individual patient and displays a settings menu similar to that shown below. The following options are available:

        Image84
    • Patient Category Dropdown Menu
      Use this dropdown menu to categorize the selected patient by category and color within a care unit in the Multi-Patient View, based on the configuration of the user. The default options are Not Set, Monitor, Telemetry, Floor, Home, and SNF. PHI must be enabled to use this feature.
    • Skin Temperature Slider
      Use the left slider and/or box to set the low limit and the right slider and/or box to set the high limit for skin temperature in degrees C (ºC) for the selected patient before a notification is sent. On the slider, the green range indicates normal values and yellow ranges indicate abnormal values (Low Default = 31°C) (High Default = 37 °C).
    • Heart Rate Slider
      Use the left slider and/or box to set the low limit and the right slider and/or box to set the high limit for resting heart rate in bpm for the selected patient before a notification is sent. On the slider, the green range indicates normal values and yellow ranges indicate abnormal values (Low Default = 50 bpm) (High Default = 115 bpm).
    • Respiratory Rate Slider
      Use the left slider and/or box to set the low limit and the right slider and/or box to set the high limit for resting respiratory rate in rpm for the selected patient before a notification is sent. On the slider, the green range indicates normal values and yellow ranges indicate abnormal values (Low Default = 8 rpm) (High Default = 28 rpm).
    • Reset to Default ButtonGraphic 105
      Click this button to reset all notification limits to their default.
    • Save Settings Button Graphic 106
      Click this button to save current notification limit settings.

4.9. Notifications

  1. Notification List
    Notifications and their associated icons that can appear on the Multi-Patient View or Clinical View and/or are shown below:
    IMPORTANT NOTE: Display PHI must be enabled in the Settings to access these features. Some of the fields shown above may not be displayed or may be different depending on your configuration.
Notification TitleIconDescription
Body Orientation NotificationGraphic 107Patient turn is overdue, with a potential indication of a turn being undone.
Heart Rate Threshold NotificationGraphic 108High Heart Rate Threshold: 60-minute median Heart Rate (X bpm) is above threshold. [Default Threshold: 115 bpm].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Graphic 109Low Heart Rate Threshold: 60-minute median Heart Rate (X bpm) is below threshold. [Default Threshold: 50 bpm].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Heart Rate Trending NotificationGraphic 110Heart Rate Increase Trending 30 minutes/2 hours: Heart rate at rest increased X % to X bpm. 30-minute notification after 2-hour baseline.
Graphic 111Heart Rate Decrease Trending 30 minutes/2 hours: Heart rate at rest decreased X % to X bpm. 30-minute notification after 2-hour baseline.
Graphic 112Heart Rate Increase Trending 1 hour/4 hours: Heart rate at rest increased X % to X bpm. 1-hour notification after 4-hour baseline.
Graphic 113Heart Rate Decrease Trending 1 hour/4 hours: Heart rate at rest decreased X % to X bpm. 1-hour notification after 4-hour baseline.
Graphic 114Heart Rate Increase Trending 2 hours/4 hours: Heart rate at rest increased X % to X bpm. 2-hour notification after 4-hour baseline.
Graphic 115Heart Rate Decrease Trending 2 hours/4 hours: Heart rate at rest decreased X % to X bpm. 2-hour notification after 4-hour baseline.
Graphic 116Heart Rate Increase Trending 4 hours/24 hours: Heart rate at rest increased X % to X bpm. 4-hour notification after 24-hour baseline.
Graphic 117Heart Rate Decrease Trending 4 hours/24 hours: Heart rate at rest decreased X % to X bpm. 4-hour notification after 24-hour baseline.
Graphic 118Heart Rate Increase Trending 24 hours/72 hours: Heart rate at rest increased X % to X bpm. 24-hour notification after 72-hour baseline.
Graphic 119Heart Rate Decrease Trending 24 hours/72 hours: Heart rate at rest decreased X % to X bpm. 24-hour notification after 72-hour baseline.
Respiratory Rate Threshold NotificationGraphic 120High Respiratory Rate Threshold: 60-minute median Respiratory Rate (X rpm) is above threshold. [Default Threshold: 28 rpm].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Graphic 121Low Respiratory Rate Threshold: 60-minute median Respiratory Rate (X rpm) is below threshold. [Default Threshold: 8 rpm].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Respiratory Rate Trending NotificationGraphic 122Respiratory Rate Increase Trending 30 minutes/2 hours: Respiratory rate at rest increased X % to X rpm. 30-minute notification after 2-hour baseline.
Graphic 123Respiratory Rate Decrease Trending 30 minutes/2 hours: Respiratory rate at rest decreased X % to X rpm. 30-minute notification after 2-hour baseline.
Graphic 124Respiratory Rate Increase Trending 1 hour/4 hours: Respiratory rate at rest increased X % to X rpm. 1-hour notification after 4-hour baseline.
Graphic 125Respiratory Rate Decrease Trending 1 hour/4 hours: Respiratory rate at rest decreased X % to X rpm. 1-hour notification after 4-hour baseline.
Graphic 126Respiratory Rate Increase Trending 2 hours/4 hours: Respiratory rate at rest increased X % to X rpm. 2-hour notification after 4-hour baseline.
Graphic 127Respiratory Rate Decrease Trending 2 hours/4 hours: Respiratory rate at rest decreased X % to X rpm. 2-hour notification after 4-hour baseline.
Graphic 128Respiratory Rate Increase Trending 4 hours/24 hours: Respiratory rate at rest increased X % to X rpm. 4-hour notification after 24-hour baseline.
Graphic 129Respiratory Rate Decrease Trending 4 hours/24 hours: Respiratory rate at rest decreased X % to X rpm. 4-hour notification after 24-hour baseline.
Graphic 130Respiratory Rate Increase Trending 24 hours/72 hours: Respiratory rate at rest increased X % to X rpm. 24-hour notification after 72-hour baseline.
Graphic 133Respiratory Rate Decrease Trending 24 hours/72 hours: Respiratory rate at rest decreased X % to X rpm. 24-hour notification after 72-hour baseline.
Temperature Threshold NotificationGraphic 132High Skin Temperature Threshold: 60-minute median Skin Temperature (Xº) is above threshold. [Default Threshold: 37º].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Graphic 134Low Skin Temperature Threshold: 60-minute median Skin Temperature (Xº) is below threshold. [Default Threshold: 31º].

Configurable for each patient in BioDashboard. Contact your BioIntelliSense Client Implementation Manager to configure globally by census, facility, and/or organization.
Temperature Trending NotificationGraphic 135The mean temperature for a 4-hour period was out of range compared to the previous 24-hour period.
Double High Threshold NotificationGraphic 13660-minute median Heart Rate (X bpm) and Respiratory Rate (X rpm) are above double-high thresholds [Default Thresholds: HR = 100 bpm, RR = 24 rpm].
Triple High Threshold NotificationGraphic 13760-minute median Heart Rate (X bpm), Respiratory Rate (X rpm), and Skin Temperature (Xº) are above triple-high thresholds [Default Thresholds: HR = 100 bpm, RR = 24 rpm, Temp = 36º].
Low Battery NotificationGraphic 138Low Battery detected.
Device Last Seen NotificationGraphic 139Most recent timestamp the device connected to a gateway
Off Body NotificationGraphic 140Sensor not attached for longer than X hours (configurable)
Heart Rate Low Signal Quality NotificationGraphic 141Heart rate at rest unavailable due to Low Signal Quality
N/AGraphic 142Off Body detected
N/AGraphic 143Low signal quality detected
N/AGraphic 144Clinical Notification Review Button (Multi-Patient View): Clinical case needs review.
Notes and Notification Reviews must be enabled in the Settings to view this icon.
N/AGraphic 145Non-Clinical Notification Review Button (Multi-Patient View): Non-clinical case needs review.
Notes and Notification Reviews must be enabled in the Settings to view this icon.
N/AGraphic 146Patient configurations have been altered
N/AGraphic 147No documented patient interactions.
“Enable RPM Reimbursement Icons in Multi-Patient View” must be enabled in Settings to view this icon.
N/AGraphic 148Less than 10 minutes of time spent.
“Enable RPM Reimbursement Icons in Multi-Patient View” must be enabled in Settings to view this icon.
N/AGraphic 149Less than 2 days of vitals data collected
“Enable RPM Reimbursement Icons in Multi-Patient View” must be enabled in Settings to view this icon.

Notification Calculations
The calculations for notifications are explained below:
IMPORTANT NOTE: BioDashboard software does not calculate notifications directly.

  • Non-Clinical Technical Notifications:
    • Low Battery Technical Notification
      The Low Battery Technical Notification generates a notification when a BioIntelliSense wearable monitoring device falls below 10% battery power remaining. The purpose of this notification is to allow clinicians to identify patients who need to recharge their BioIntelliSense wearable monitoring device battery.
    • Device Last Seen Technical Notification
      The Device Last Seen Technical Notification notifies clinicians of patients who may be having technical issues with their BioIntelliSense wearable monitoring device. A notification is triggered when a BioIntelliSense wearable monitoring device has not synchronized data to BioCloud for at least X hours (Default 4 h).
    • Heart Rate Low Signal Quality Technical Notification
      In certain situations, BioIntelliSense wearable monitoring device firmware may not be able to capture heart rate readings despite being worn on a patient’s body and the patient being at rest. This occurs when the quality of the signal obtained from the accelerometer is not high enough to distinguish heartbeat pulses. The Heart Rate Low Signal Quality Notification identifies situations when all of the following criteria are met during an hour of a patient wearing BioIntelliSense wearable monitoring device and triggers a notification:
      • The patient was resting, as evidenced by low motion readings; and
      • No heart readings were obtained during the hour.
    • Off-Body Technical Notification
      The outputs of the Off-Body Determination Algorithm are used to produce a technical notification to notify a clinician when a patient has not worn the BioIntelliSense wearable monitoring device for a configurable minimum length of (consecutive) time. By default, the notification is triggered when the device has been off-body for at least four (4) consecutive hours. A Random-Forest machine learning algorithm uses BioIntelliSense wearable monitoring device data to determine if the device is off body at any given minute.
  • Body Orientation Tracker Clinical Notification
    The Body Orientation Tracker (BOT, or the device) monitors the orientation and movements of bedridden patients. The device takes input from compatible Food and Drug Administration (FDA)-cleared medical devices and calculates the time since patient’s last rotation as outputs. The device provides notifications when characteristics of a patient’s position deviate from preset parameters. The notification is triggered when either of the following conditions are true:
    • Rotation Overdue Notification
      The patient has not been rotated at least X degrees (Default = 30 degrees) in X minutes (Default = 150 minutes) (i.e. the patient requires rotation).
    • Rotation Undone Notification
      The patient has reverted at least 20 degrees back to their original position within Y minutes (Default = 15 minutes) of being rotated (i.e. the patient reverted to their original position too quickly after being rotated). The user will receive a notification to rotate the patient for this condition only if the patient has also not been rotated in X minutes (Default = 150 minutes) as is configured above.
  • Personalized Trending Clinical Notifications
    These clinical notifications are triggered when a clinically and statistically meaningful increase or decrease in a single vital sign (heart rate or respiratory rate) occurs over a defined period of time. The following criteria outlined in the description and table below must be met for each notification to be triggered.
    • Increase Notification is Triggered When Both Below Are True:
      • Percentage Change >= Percentage Change Threshold
      • Cohen’s D Threshold >= Cohen’s D Threshold
    • Decrease Notification is Triggered When Both Below Are True:
      • Percentage Change <= (-Percentage Change Threshold)
      • Cohen’s D Threshold <= (-Cohen’s D Threshold)
  • IMPORTANT NOTE: Cohen’s D thresholding is not used for the 30-minute vs. 2-hour and 1-hour vs. 4-hour notifications.
  • Threshold Clinical Notifications:
    • High Heart Rate Threshold
      Heart rate 60-minute median is above 115 bpm for in-facility patients and above 105 bpm for at-home patients (configurable by patient).
    • Low Heart Rate Threshold
      Heart rate 60-minute median is below 50 bpm (configurable by patient).
    • High Respiratory Rate Threshold
      Respiratory rate 60-minute median is above 28 rpm for in-facility patients and above 26 rpm for at-home patients (configurable by patient).
    • Low Respiratory Rate Threshold
      Respiratory rate 60-minute median is below 8 rpm (configurable by patient).
    • High Skin Temperature Threshold
      Temperature 60-minute median is above 37°C (98.6°F) (configurable by patient).
    • Low Skin Temperature Threshold
      Temperature 60-minute median is below 31°C (87.8°F) (configurable by patient).
    • Double High
      60-minute median heart rate is above 100 bpm, and 60-minute median respiratory rate is above 24 rpm.
    • Triple High
      60-minute median heart rate is above 100 bpm, and 60-minute median respiratory rate is above 24 rpm, and 60-minute median skin temp is above 36°C (96.8°F).

      Notification Delays
      The display of notifications in the user interface will be delayed by the processing of their signals. A summary of the delays associated with each signal processing step is shown in the table below:

Signal Processing StepDuration of Delay
Vital Sign Calculation60 seconds
Data Offloaded from BioIntelliSense wearable monitoring device to Gateway to BioCloud20 minutes (average)
Data Received in BioCloud to Data Fully Decrypted and Processed0.631 seconds (average)
Data Fully Processed to Algorithm Output Calculation67.7 seconds (average personalized heart rate/respiratory rate notifications), 61.7 seconds (average personalized skin temperature notifications), and 68.7 seconds (average threshold notifications)
Notification Output Determination to Notification Delivery from BioCloud to Internal Messaging Service (i.e. Confluent)0.52 seconds (average)
BioDashboard Receiving a New Notification Message from Internal Messaging Service (i.e. Confluent) to Displaying Notification Icon in User Interface69.2 seconds (average)
Total Processing Time23.3 minutes

4.10. Patient Registration

BioDashboard Registration
When the Add Patient Button Graphic 150 is clicked in Multi-Patient View (described above), the following registration form is displayed. Enter the registration information for the new patient and click the “+Add Patient” button to register the patient. A Bio ID must be entered to begin collecting data with a BioIntelliSense device. A new patient cell will appear in the Multi-Patient View for this patient in a few moments.
IMPORTANT NOTE: Display PHI must be enabled in the Settings to access these features. Some of the fields shown above may not be displayed or may be different depending on your configuration.

Image95
  1. BioDashboard Edit Patient Registration
    When the Edit Patient Button Graphic 151 is clicked in the Clinical View (described above), the following registration form is displayed. Enter the updated information for the new patient and click the “Save” button to update the patient information. A new Bio ID may be entered to begin collecting data with a new BioIntelliSense device. The updated patient information will appear in the corresponding patient cell in the Multi-Patient View and Clinical View for this patient in a few moments after editing.
    IMPORTANT NOTE: Display PHI must be enabled in the Settings to access these features. Some information is unable to be updated with the update patient registration form and will appear in gray. Some of the fields shown above also may not be displayed or may be different depending on your configuration.
    Image97

    Electronic Medical Record Patient Registration
    Patients can also be registered, transferred, or discharged through the electronic medical record (EMR), if applicable. Contact your hospital administrator for more information.

4.11. Help Menu

When the Help Menu Icon Graphic 152 is clicked in Multi-Patient View (described above), the following help menu is displayed. The following options are available:

  • Help
    Click tab to display the Help Pages. This lists the help options that are available and the BioIntelliSense Technical Support Email Address.
  • Color Limits
    Click this tab to display definitions of colors for vital signs in the Multi-Patient View and for body organs and other biometrics in the Clinical View.
  • Icons and Notifications
    Click this tab to display definitions of notifications and their associated icons.
  • Selected Census Dropdown Menu
    Click this dropdown menu to view the different census configurations for color limits and notifications, based on the configuration available.
    Image98

4.12. About Menu

Clicking the About Button Graphic 153 / Graphic 154 in the banner on the left side of the screen displays the BioDashboard version number and other software identification information, as well as provides access to the BioDashboard Instructions for Use.

Image99

5. Troubleshooting and FAQs

If additional support is required, please call 888.908.8804 (US) or email support@biointellisense.com

IMPORTANT NOTE: Some features described in this document may not be functional on mobile devices.

6. Safety and Regulatory Information

Version Number0002
Model NumberSW-BDB
Product NameBioDashboard V2
Part Number (PN)SW-BDB-0002
GTIN00850005949466

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

BioIntelliSense, BioDashboard and BioButton are trademarks or registered trademarks of BioIntelliSense, Inc.

RESPONSIBLE PARTY:

BioIntelliSense, Inc.
805 Veterans Blvd, Unit 105
Redwood City, CA 94063

6.1. Terms of Use Statement

NOTICE: Use of the BioIntelliSense Product(s) is subject to our:

By using the Product(s), you indicate you have read these terms and policies and that you agree to them, including the limitations and disclaimers of liability. In particular, you understand and consent that use of the Product(s) measures and records personal information about you, including vital sign and other physiologic measurements. That information may include respiratory rate, heart rate, temperature, activity level, sleep duration, body position, step count, gait analysis, coughing, and other symptomatic or biometric data. You understand that the Product(s) do not render medical advice or diagnose or prevent any specific disease, including any communicable disease or virus. If you have any concerns about your health, including whether you have been exposed to or have contracted any disease or virus, immediately contact your healthcare provider.

7. Symbol Library

A black and white rectangular sign with a letter in it Description automatically generatedMedical device
A black and white symbol with a black letter Description automatically generatedConsult instructions for use
Picture 1486874002Caution
Image102For prescription use only

8. Technical Specifications

Product nameBioDashboard V2
Version Number0002

8.1. Communications

SecurityAES 128 bit encryption/TLS 1.2 for data transfer
AES 256 bit encryption for data at rest

9. Contact Us

For non-urgent support or questions about our product, please call 888.908.8804 (US) or email support@biointellisense.com

Manufactured by

BioIntelliSense, Inc.
805 Veterans Blvd, Unit 105
Redwood City, CA 94063