strados

 

Slides 1–18

Slide 1 — SHORE Study Site Training

SHORE Study
Site Training

Study_SHORE@stradoslabs.com

TD-00068 SHORE Study - Site Training Rev B
Confidential and Proprietary to Strados Labs, Inc.

Slide 4 — Subject Journey Map

Study Visit Types

Day 0

• Subject is trained on Biosensor, Pulse Oximeter, Questionnaire, and Spirometer.
• Enrollment spirometry is performed by study personnel.
• Devices are dispensed.

At-Home Activity

• Before sleep, the subject is prompted to complete their questionnaire and pulse oximetry reading. Then, they open the Strados app, connect devices, start a 10hr recording session, and perform study activities.
• At wake-up, the subject performs their study activities, removes the Biosensor, charges it, and initiates data transfer.

At-Home Activity with Spirometry

• Before sleep, the subject is prompted to complete their questionnaire, pulse oximetry reading, and spirometry measurement. Then, they open the Strados app, connect devices, start 10hr recording session, and perform study activities.
• At wake-up, the subject performs their study activities, removes the Biosensor, charges it, and initiates data transfer.

The timeline is divided into Days 0–6, 7–13, 14–20, 21–27, and 28–30. It marks at-home activities and designated spirometry sessions.

Slide 8 — RESP Kit Overview

RESP Biosensor System Kit Content:

• 1 RESP Biosensor
• 1 RESP Single Charger
• 65 Strados Patient Adhesives
• 65 3M Cavilon™ No Sting Barrier Film wipes
• 75 Cleaning Wipes
• 1 Study Mobile Device

Also Included:

• 1 MIR Spirobank
• 1 Fingertip Oximeter

Slide 9 — RESP Biosensor

Features

• Low profile
• One button operation
• Blink codes provide status

Biosensor LED Behavior after Double Tap	Operating Mode
None	Biosensor is powered off
Continuously Flashing	Biosensor is advertising to pair with mobile device via Bluetooth
1 Flash	Biosensor is on but not recording
5 Flashes	Biosensor is on and recording

Slide 12 — Cleaning Wipes and Cavilon Barrier Film Wipes

Cleaning Wipes — Features

• Disinfect and clean equipment
• Biosensor is validated to endure at least 180 cleaning cycles
• Charger is validated to endure at least 300 cleaning cycles

3M Cavilon™ No Sting Barrier Film Wipes — Features

• Applies a fast-drying barrier film to prepare the application site for the patient adhesive

Slide 13 — Partial slide

The screenshot shows the bottom of a slide with a Strados logo. The slide title and most content are not visible.

Slide 14 — Fingertip Oximeter

Features

• Display screen
• Single button
• Automatic power-off

Readings taken on days of RESP recordings.

Slide 15 — Strados Mobile App (SMA)

App Features

• User friendly interface to interact with the RESP
• Provides interface between the Biosensor and cloud
• Facilitates secure data upload
• Guides user through the measurement process

Slide 17 — Charging the Biosensor

At least 3 hours before starting the screening visit:

1. Unpack the RESP™ Biosensor System (keep packaging)
2. Charge the Biosensor

The image labels the blue indicator as the Charging Light.

Slide 18 — Powering the Spiro & Pulse Oximeter

Ensure study devices have adequate power.

Slides 19–31

Slide 20 — Log into the Strados Clinician Portal

Study team members should receive an activation email. Once received:

• Go to https://portal.stradoslabs.com/
• Follow the instructions in the account activation email from support@stradoslabs.com

Note: Once the activation email is received, accounts must be activated within 96 hours.

Slide 21 — Terms and Conditions

Read and accept the Terms & Conditions.

Slide 22 — Add a User in the Strados Clinician Portal

• Select the “Users” tab from the menu bar at the top of the screen.
• Select “Add User.”

Slide 23 — Add a User in the Strados Clinician Portal

• Under the User Type, select “Site User.” Enter information into the following fields:
  • First Name
  • Last Name
  • Email Address
• Select all of the permission checkboxes. Then, select “Save.”
• The new user will receive an account activation email to access the Strados Clinician Portal.

Slide 24 — Add a Subject in the Strados Clinician Portal

• Select the “Patients” tab from the menu bar at the top of the screen.
• Select “Add patient.”

Slide 25 — Add a Subject in the Strados Clinician Portal

• Enter the assigned subject ID. Then select “Save.”

Example shown: Subject ID: 1-___

Slide 26 — Assigning a Prescription

• To assign a prescription to the patient, select the “RESP Prescription” tab from the patient record just created.
• Select the “+” icon on the right side of the screen to add a new prescription.
• Select “Save” to continue. (This instruction is visible at the top of the next slide.)

Slides 31–56

Slide 31 — Open the RESP Mobile App

• Select the RESP Mobile App icon on the study-provided mobile device.

Slide 32 — Enable Permissions

• If prompted, select While Using the App or Allow for all permissions.

Slide 36 — Device Connection: Matrix Code Scan

• Align the study-provided mobile device camera with the matrix code on the Biosensor label. The app will then connect.

Alternative Pairing Method: Search for Nearby Devices.

Slide 38 — Partial slide

Visible text:

• “…connection”
• Area should be free of excessive oils and lotions to maximize adhesion.

The title and preceding instruction are cut off.

Slide 39 — Apply the 3M Cavilon™ Wipe

• Obtain a 3M Cavilon™ No Sting Barrier Film wipe.
• Apply a uniform coating over the entire area of concern.
• Wait for the area to thoroughly dry (approximately 30 seconds).

Slide 40 — Preparing the Adhesive

• Remove the adhesive backing.
• Place the Biosensor on the adhesive with its label facing down.

Slide 43 — Finish attachment

• Select “Next Step.”

Slide 44 — Starting the Test Recording

• Select “Begin Test Recording” to start a test recording.

Slide 46 — Test Recording

• The test recording will begin counting down from 15 seconds.
• During the test recording, ask the subject to cough a few times.
• After the recording finishes, the recording will begin to transfer automatically.

Slide 49 — Starting a Recording Session

• The continuous recording checklist will appear.
  • Note: The device must be charged to start a recording session. If the battery level is below the required level, the app will notify you.
• Select the button to start the recording session. The Biosensor disconnects from the Mobile App. The Mobile App displays a countdown timer.
• Subject continues with daily or study activities.

Slide 50 — During a Recording Session

• Keep the study-provided mobile device and set up the charger next to each other.

Slide 51 — Finishing Recording Session

• After sleeping or at least 4 hours, remove the Adhesive and Biosensor.
• Place Biosensor on charger.
• Recording Complete screen may prompt.
• Select “Next Step.”

Note: Placing the Biosensor on the charger will stop the recording!

Slide 53 — Place Biosensor on Charger

• Place the Biosensor on the charger. Select “Next.”
• If you cannot select “Next,” charge the Biosensor for a few minutes and press the power button to turn it on. The Biosensor will begin blinking and stop when it connects to the mobile device.

Note: The blue charging light on the charger will come on when the Biosensor is charging.

Slide 54 — Transfer Recordings

Visible text:

• Continue to charge the Biosensor and mobile device.
• Keep the Mobile App open and keep the Biosensor near the mobile device… (remainder is cut off in the screenshot)

Slide 55 — Finishing Recording Transfer

• Select “Next.”

Slide 56 — Next Steps

• Standby on this screen until the next scheduled recording session or repackaging at the end of study.
  • Continue charging the Biosensor and study mobile device.

Note: Do not select “End Study” until the last study recording session and data transfer is complete.

Slide 57 — Enroll in GoMo (eDiary)

• Enroll the subject: https://strados.gomohealth.care/enroll/
  • Insert Subject ID (1-____)
  • Insert Phone Number
  • Insert Typical Bedtime
• Subject receives Welcome Text Message.
• Subject receives first eDiary text 2 hours prior to bedtime.

Note: Refer to Program Overview for more info.

Slide 58 — Complete Spirometry Reading & Training

• Open the Strados RESP Spiro App.
  • Follow on-screen instructions:
    • Scan QR code
    • Enter Subject ID
    • Connect SpiroBank
• For the test, follow on-screen instructions:
  1. Place nose clip onto your nose.
  2. Place your mouth onto the turbine.
  3. Breathe in as much as you can.
  4. Tap on “START TEST”.
  5. Breathe out as fast and hard as you can.
  6. Breathe in as much as you can.
• Finish test and select “Stop Test”.

Note: Take multiple recordings to ensure subject understanding.
Note: Step by step instructions in Site Guide and Patient Guide.

Slide 59 — Complete Pulse Oximetry Reading & Training

• Clip the pulse oximeter on the subject’s finger.
• Ensure subject understanding.

The top of the screenshot also shows:

• Finish test and select “Stop Test”.
• Note: Take multiple recordings to ensure subject understanding.
• Note: Step by step instructions in Site Guide and Patient Guide.

Slide 60 — Subject Participation Checklist

Don’t forget the Subject Participation Checklist!

The checklist is headed with:

• Participant Study ID
• Study Site
• Study Site #
• Study Code: SL-RS-SHORE
• Study Name: Utility of remote lung auscultation in COPD with RESP™ Biosensor
• Columns: Study Day, Date, Tasks, Complete

Day 1 — At Bed Time

1. Complete eDiary Questionnaire (via text link at bedtime)
2. Complete Pulse Oximetry Reading (Record in eDiary)
3. Apply RESP Biosensor and Record via Mobile App
4. Take 6 Deep Breaths
5. Engage in Moderate Exertional Activity
6. Take 6 Deep Breaths

Day 2 — At Wake Up

1. Record 6 Deep Breaths
2. Remove & Charge RESP Biosensor & Transfer Data

At Bed Time
3. Complete eDiary Questionnaire
4. Complete Pulse Oximetry Reading & Record in eDiary
5. Complete Spirometry Reading & Record on Paper Form
6. Apply RESP Biosensor and Record via Mobile App
7. Take 6 Deep Breaths
8. Engage in Moderate Exertional Activity
9. Take 6 Deep Breaths

Day 3 — At Wake Up

1. Record 6 Deep Breaths
2. Remove & Charge RESP Biosensor & Transfer Data

At Bed Time
3. Complete eDiary Questionnaire (via text link at bedtime)
4. Complete Pulse Oximetry Reading (Record in eDiary)
5. Apply RESP Biosensor and Record via Mobile App
6. Take 6 Deep Breaths
7. Engage in Moderate Exertional Activity
8. Take 6 Deep Breaths

Slide 64 — Diary Questionnaire

• The subject answers each of the 14 questions.

The tablet image is labeled SHORE Patient Survey and shows fields for Patient ID, Patient Name, and Oxygen Level from Pulse Oximeter. The two legible example questions are:

1. Did your chest feel congested today?
2. How often did you cough today?

Slide 66 — Ready for the Biosensor

• The subject should remove the Biosensor from the Charger.
• Turn it on by pushing the power button.

Note: The device MUST be charged to start a new recording session.

Slide 68 — Apply the Biosensor

• Apply the Biosensor and adhesive in the placement area shown in the Mobile App.
• Smooth the adhesive ensuring a tight seal is created on the skin.

Slide 70 — Recording Session

• Start the <10-hr recording session.
• 6 deep breaths.
• Moderate activity.
• 6 deep breaths.

Note: Charge mobile device at all times to ensure power.

The diagram depicts the sequence as breathing, activity, then breathing again. It shows either a short activity option or a 30-minute activity option.

Slide 71 — End Recording Session and Data Transfer

Only the slide title is visible in the screenshot; the rest of the slide is cut off.

Slide 74 — MIR Spirobank Device

Readings taken upon enrollment & Day #30

• Open Strados RESP Spiro Mobile App.
• Select “START TEST”
  • Follow on-screen instructions.
  • Select “STOP TEST”.
• The results will display and save within the app.

Note: If a result is concerning, we encourage the subject to contact their healthcare provider for further evaluation. This device’s findings should not replace professional medical advice.

Slide 83 — Biosensor does not turn on

Potential causes:

1. Biosensor is out of battery.
2. Biosensor is unresponsive.

Troubleshooting Steps:

1. To determine if the Biosensor is on, tap it twice anywhere.
   • If the Biosensor blinks, hold the power button for 5 seconds to turn it off.
2. Place the Biosensor on the charger.
   • The blue charging light on the charger should be on.
     • Ensure charger is powered (green power light is on).
     • Ensure the Biosensor is correctly seated in the charger.
3. Charge the Biosensor.
   • A completely discharged Biosensor must be charged for at least 3 hours to achieve full charge.
4. Power on the Biosensor.
   • The Biosensor will begin blinking.

Slide 87 — Data upload issues

Potential Causes:

1. Biosensor is turned off.
2. Poor network connection.
3. Biosensor is not charged.

Troubleshooting Steps:

1. Place the Biosensor correctly on the charger.
   • The blue charging LED and green LED on the charger should be on.
2. Double tap anywhere on the Biosensor.
   • If it does not blink, charge the Biosensor for a few minutes and power on the device by pressing the biosensor button for 2 seconds.
3. Check the study-provided mobile device’s network connection. If necessary, switch to a different Wi-Fi network.
4. If the app screen displays the “Retry” button, tap it to restart the transfer.
5. If the issue persists, restart the Biosensor and mobile device