Support Center

Paired Kits and Portal Training Guide

Last Updated: Aug 08, 2016 06:25PM EDT
1. Activity/Sleep Watch 4. Gateway Notes 1. Regarding the Gateway      3.1 Align the charger posts with the contacts on the back of the device, and press the charger until it clicks 1. Kit Returns 1. Upon successful username and password entry 1. Upon successful username and password entry into the portal, information of any existing registered subject can be updated at any time via the Administration Table’s ‘edit’ function
    1.1 Attributes which can be updated: Screening ID, Year of Birth, Gender, and assigned Kit.
2. Click on the ‘edit’ link for the subject you’d like to edit – this populates all fields with the subject’s data (1)
3. Update the desired attributes and click on ‘Register Subject’
    3.1  You will see a dialog box pop-up indicating a successful update

Deactivate Existing Subject
1. Upon successful username and password entry into the portal, any existing registered subject can be deactivated
2. Deactivation of a subject disassociates the ‘Kit’ with the subject, so no additional data is collected for that subject
3. This action can be taken for two reasons
    3.1  The subject has completed the trial (end of trial deactivation)
   3.2 The subject has been terminated from the study prior to completion of the trial
4. Click on the ‘edit’ link for the subject you’d like to deactivate (1)
5. Select ‘Deactivate Subject’ from the ‘Select Action’ drop down (2)
    5.1. If you need to discard any changes made to the subject’s information, Click ‘Cancel’ to exit the ‘edit’ mode
6. Click ‘Submit’ to save the changes that have been made
    6.1 You will see a dialog box pop-up indicating a successful update

Reassign Subject’s Kit
1. Upon successful username and password entry into the portal, click on the ‘edit’ link for the subject you’d like to edit (1)
2. Reassigning a kit does not impact the subject’s data collection
3. Potential reasons for Kit reassignment
    3.1 This is not expected to happen frequently, but if a kit were to malfunction, the Kit should be exchanged so the subject’s activity/sleep watch can resume data collection 
4. Click on the ‘edit’ link for the subject you’d like to reassign a Kit for (1)
5. Change the Kit number from the “Select Kit” drop down
    5.1 You will see a dialog box pop-up indicating a successful update

Additional Portal Functionality
1. Capture Notes(3)
    1.1 This feature allows the capture of notes related to the subject for operation purposes
    1.2 This data is not captured for reporting
2. Search (4)
    2.1 Search capabilities are provided – enter the Screening ID to access any specific subject
3. Data Monitoring
    3.1 The Sleep/Activity watch in the ideal state will synchronize every 24 hours
    3.2 If a subject’s data fails to synchronize, their data will appear in red text in the Administration Table to identify them as potentially needing attention
    3.3 Date of last synchronization will appear in the Administration Table to provide an indication of how long it has been since the last data capture (5) 

Subject Data – Chart Access
Support Portal
 

Sleep Study Kit Components

1. Activity/Sleep Watch

  1. Commercial name:  Garmin vivosmart HR
      1.2.
      1.2.1          Press and hold the “device key” to turn on the watch
      1.2.2          Disclaimer: this is NOT a medical device. Intended for exploratory/observational purposes  only
      1.3. Charging Cable

 

2. Activity/Sleep Watch Notes

      2.1 Screen will come covered with a black adhesive sticker to minimize subject engagement with the device
            2.1.1 Screen Covers can be removed for cleaning
            2.1.2 Replacement screen covers are provided with each kit, which can be given to the subject in case replacement is needed or used by Study Personnel to replace screen covers on site.
      2.2 Watches provided will be already paired with the Gateway
      2.3 Ensure pairing when assigning Kit to a subject
            2.3.1 Confirm Watch and Gateway are Paired
                    2.3.1.1 Ensure the “Gateway” tablet is powered on
                    2.3.1.2 Confirm “Gateway” is accessing the WiFi
                               2.3.1.2.1 For WiFi instructions, see section 4.1
                    2.3.1.3 On the watch, press the “device key” to view the menu
                               2.3.1.3.1 
Swipe screen from right to left and Select 
                    2.3.1.4 If paired, the watch will display “Bluetooth Connected”
                    2.3.1.5 Select the to return to the menu and replace the sticker
                    2.3.1.6 If the watch is not paired it will display “syncing or waiting for app”
                               2.3.1.6.1 Ensure the “gateway” tablet is turned on and is in close proximity to the watch and they will automatically connect
                    2.3.1.7 Select the to return to the menu and replace the screen cover on the watch
                    2.3.1.8 If pairing still does not occur within 2-3 minutes, please contact support for assistance pairing

            2.3.2 Kit Syncing process
                    2.3.2.1 Syncing via the “Gateway”
                               2.3.2.1.1 Ensure the “Gateway” tablet is powered on
                               2.3.2.1.2 Enter the “PIN” and select the to unlock the tablet
                                             2.3.2.1.2.1 For PIN Code sec, section 4.1
                               2.3.2.1.3 To confirm that watch is data is syncing, double tap the Garmin “Connect” icon from the Home Screen on the tablet and the app will open
                                             2.3.2.1.3.1 At the bottom of the screen you will see a color bar appear notifying you that the device is syncing and confirm when the sync has completed
                                             2.3.2.1.3.2 Do NOT log out of the “Connect” app and return to “Home Screen”
                    2.3.2.2 Syncing via the watch
                               2.3.2.2.1 
On the watch, press the “device key” to view the menu
                               2.3.2.2.2 Swipe screen from right to left and Select
                               2.3.2.2.3 Watch display will change to a show device syncing
                               2.3.2.2.4 Once completed display will change to “Data Transfer Complete”   

 
 
   

3. Gateway
1. Samsung Galaxy Tab E or Posh Mobile Equal S700
2. Charging Cable & USB Wall Plug

 
4. Gateway Notes
4.1 PIN Code to unlock the screen
     4.1.1. PIN Code: 76247468

4.2 Activating the WiFi
     4.2.1 Ensure the “Gateway” tablet is powered on
     4.2.2 Enter the “PIN” and select the to unlock the tablet
     4.2.3 From the Home screen swipe down from the top corner of the screen and select “settings”
     4.2.4 Select “WiFi”
     4.2.5 Ensure “WiFi” is turned on, select the name of your WiFi network from the dropdown
     4.2.6 Enter the password for your WiFi network and select “Connect”
     4.2.7 Once connected the “WiFi” will show connected, return to the “Home Screen”

4.3 Solely intended for data collection
4.4 Tablet Form-factor
4.5 Gateway will be locked to prevent subject interaction
      1.1.1 Please see above for PIN code if access is needed (section 4.1)



 

5. Additional Wall Plugs/Connections

5.1 Dual USB Wall Plug
 


5.2 Additional Notes on Wall Plugs
     5.2.1 Both the Gateway and the Watch can be charged at the same time with these devices
     5.2.2 Gateway should remain plugged in at all times 

 

6. Screen Covers

6.1 The activity/sleep watch comes with an existing screen cover
6.2 Additional screen covers are provided as replacements
6.3 In the event the screen cover falls off, additional screen covers may be provided to the subject/Trial Partner to facilitate self-maintenance without the need for additional site visits
6.4 To adhere a new screen cover
      6.4.1 Gently remove the cover from the provided sheet
      6.4.2 Place the new screen cover along the lower edge of the activity/sleep watch display screen centered horizontally to align with the lower section of the interior screen
      6.4.3 This will allow for the error and battery icons to display along the top right hand corner of the activity/sleep watch screen
 
 
 

 

Kit Assignment by Study Coordinator

1. Steps in assigning kits to subjects

1.1 Register and assign Kit to Subject on the Sleep Registration Portal
     1.1.1 See instructions in Subject Registration section
1.2 Ensure that both the activity/sleep watch and the gateway have sufficient charge before Kit assignment
1.3 Validate that no errors are present on the watch screen
1.4 If there are any sync issues ‘!’ will be displayed on the top right hand corner
1.5 Ensure activity/sleep watch and gateway provided to subject have the same kit number 

 

Subject Instruction When Kit Is Assigned

1. Regarding the Gateway

1.1 You’ll receive a ‘Gateway’ similar to the one pictured below.
1.2 The Gateway transmits the data from the watch to the Sponsor.
1.3 Connect the Gateway to an electrical outlet in a room frequently visited by the subject.
1.4 Keep the Gateway plugged into the electrical outlet at all times.
1.5 If traveling for more than three days, you must bring the Gateway with you to prevent data loss.


 

 

2. Watch and USB Chargers

2.1 The subject should wear the watch at all times, preferably on their non-dominant arm.
2.2 The device should consistently be worn on the same arm throughout the trial.

 

3. Charging the Sleep Watch

3.1. Align the charger posts with the contacts on the back of the device, and press the charger until it clicks
 
 
 


3.2 Connect the electric power adaptor to your wall
3.3 Connect the watch charger to the Gateway’s USB wall-charger
      3.3.1 Alternatively you can also use your cell phone USB wall-charger or your computer
 
 


3.4 When connected correctly, the display will indicate that it is charging
      3.4.1 A small battery icon will appear in the top right hand corner of the device not obscured by the screen cover
3.5 Charge the watch for 1.5 hours every 3 days and preferably in the morning. 

 



Kit Returns & Cleaning Instructions

1. Kit Returns

1.1 Ensure all Kit components are returned and undamaged
1.2 
Validate activity/sleep watch is synchronized with the gateway
      1.2.1.1 Syncing via the “Gateway”
                 1.2.1.1.1 Ensure the “Gateway” tablet is powered on
                 1.2.1.1.2 Enter the “PIN” and select the to unlock the tablet
                               1.2.1.1.2.1 For PIN Code, see section 4.1
                 1.2.1.1.3 To confirm that watch is data is syncing, double tap the Garmin “Connect” icon from the Home Screen on the tablet and the app will open
                               1.2.1.1.3.1 At the bottom of the screen you will see a color bar appear notifying you that the device is syncing and confirm when the sync has completed
                               1.2.1.1.3.2 
Do NOT log out of the “Connect” app and return to “Home Screen”
1.3 Deactivate Kit via the Portal as soon as received from subject to ensure data collection is stopped. See Subject Deactivation section.
 

Cleaning Instructions

2.1 Clean activity/sleep watch between subject assignments
      2.1.1 Dampen a soft cloth with warm or cool water and use mild dish soap to remove any dirt or grease. An alcohol wipe can be used.
      2.1.2 Clean everything - sensors and sides.
2.2 Do Not Use
      2.2.1 Hot water
      2.2.2 Abrasive brush or sponge
      2.2.3 Bleach or abrasive cleansers
 

Registration Portal

1. Study Personnel Registration Portal Access

1.1 Access URL: contact support for URL
1.2 User Name and Password will be emailed to all study personnel
1.2.1 You will be subsequently prompted to change your password
1.3 Access to Support is available upon Portal Log In 
 

Sleep Registration Portal – Login Screen Capture


 

Subject Registration

1. Upon successful username and password entry

1.1 Site Coordinators will gain access to the Site Administration and Subject Registration Page
1.2 This is the primary page for all subject administration including registration, edits, deactivation and kit assignments

 

2. To register the subject, enter the following:

2.1 Subject’s screening ID – 5 digit number (1)
2.2 Year of Birth – 4 digit year (2)
2.3 Gender – select Male/Female (3)
2.4 Select Kit number provided to the subject (4)
2.5 Click on ‘Register Subject’ – the subject’s registration will be registered in the system (5)
2.6 Subject data will be updated in the Administration Table at the bottom of the page with all associated data displayed (6)
2.7 All registered subjects (deployed or deactivated) will appear in the Administration Table

 
Subject Registration Page - Capture

 

Editing Subject Information

1. Upon successful username and password entry into the portal, information of any existing registered subject can be updated at any time via the Administration Table’s ‘edit’ function
    1.1 Attributes which can be updated: Screening ID, Year of Birth, Gender, and assigned Kit
2. Click on the ‘edit’ link for the subject you’d like to edit – this populates all fields with the subject’s data (1)
3. Update the desired attributes and click on ‘Register Subject’
    3.1 You will see a dialog box pop-up indicating a successful update 

 

Deactivate Existing Subject

1. Upon successful username and password entry into the portal, any existing registered subject can be deactivated
2. Deactivation of a subject disassociates the ‘Kit’ with the subject, so no additional data is collected for that subject
3. This action can be taken for two reasons:
    3.1 The subject has completed the trial (end of trial deactivation)
    3.2 The subject has been terminated from the study prior to completion of the trial
4. Click on the ‘edit’ link for the subject you’d like to deactivate (1)
5. Select ‘Deactivate Subject’ from the ‘Select Action’ drop down (2)
    5.1 If you need to discard any changes made to the subject’s information, Click ‘Cancel’ to exit the ‘edit’ mode
6. Click ‘Submit’ to save the changes that have been made
    6.1 You will see a dialog box pop-up indicating a successful update

 

Reassign Subject’s Kit
1. Upon successful username and password entry into the portal, click on the ‘edit’ link for the subject you’d like to edit (1)

2. Reassigning a kit does not impact the subject’s data collection.
3. Potential reasons for Kit reassignment:
    3.1 This is not expected to happen frequently, but if a kit were to malfunction, the Kit should be exchanged so the subject’s activity/sleep watch can resume data collection.
4. Click on the ‘edit’ link for the subject you’d like to reassign a Kit for (1)
5. Change the Kit number from the “Select Kit” drop down
    5.1 You will see a dialog box pop-up indicating a successful update

 

Additional Portal Functionality

1. Capture Notes (3)
    1.1 This feature allows the capture of notes related to the subject for operation purposes
    1.2 This data is not captured for reporting
2. Search (4)
    2.1 Search capabilities are provided – enter the Screening ID to access any specific subject
3. Data Monitoring
    3.1 The Sleep/Activity watch in the ideal state will synchronize every 24 hours
    3.2 If a subject’s data fails to synchronize, their data will appear in red text in the Administration Table to identify them as potentially needing attention
    3.3 Date of last synchronization will appear in the Administration Table to provide an indication of how long it has been since the last data capture (5)
 
Subject Editing, Deactivation, Kit Reassignment, & Additional Functionality - Capture
 
 
 


 
Subject Data – Chart  Access
1. Study Coordinators can view Subject data
​​    1.1 Site Coordinators access subject data via the Administration Table by clicking on the ‘View Data’ link
          1.1.1 A Pop-up chart will be generated
​    1.2 Data reflects Average values
          1.2.1 Steps, Sleep, Heart Rate and Calories
    1.3 Chart reflects daily totals across the same measuresSubject Data View - Capture

 
 
 


 
1.4 This data snapshot provide Study Coordinators the ability to quickly troubleshoot issues including
      1.4.1 Data anomalies
      1.4.2 Device synchronization

Subject Data View with Anomalies - Capture

 
 
 
 


Support Portal

1. Content includes​​
    1.1 FAQs
    1.2 Training Materials & Videos
    1.3 Email support
         1.3.1 Requesting additional components or replacements
         1.3.2 Mismatched components
         1.3.3 General questions
    1.4 Live Chat support
         1.4.1 Access to Registration Portal
         1.4.2 Attempting to sync device
         1.4.3 Registration portal not accessible
         1.4.4 Data anomalies or missing data
         1.4.5 Device malfunction

2. Access Details
    2.1 Hours of Support:
         2.1.1 Monday through Friday
         2.1.2 8 AM to 12 AM (US EST)
    2.2 After hours support
          2.2.1 Email response within 24 hours
 

 

 



 

 









 

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