Instructions for Use

Introduction

Swaasa AI Platform is Software as a Medical Device for screening and diagnostic aid in the assessment of respiratory diseases or conditions. 

Pre-Use Requirements and Dependencies

Android smartphone / tablet with version 5.x and above. Web application and Dashboard can be accessed from any web browser on Mobile, Desktop, Laptop, and Tablet.

The inbuilt microphone must meet the following requirements. 

  • Audio frequency range 20Hz -20kHz
  • Sensitivity: -26 dB to +/-2dB
  • Maximum sound pressure level: 98dB – 120 dB SPL
  • Dynamic range: 60dB

Software Installation, Upgrade and Configuration

Search for “Swaasa” app on play store and install the application. If auto update is not enabled on your phone, make sure to take the latest version of the app before using it. 

 

Register and Create Patient Profile

  • Using Swaasa application on mobile device, register as a new user. You can enrol as doctor or medical practitioner or medical technician.
  • Once you create the profile you can login as an existing user.
  • Create a new patient ID or  select an already existing ID.

Performing Assessment

  • Once an ID is selected or created, provide symptoms data.
  • After symptoms data, record cough sounds. Follow the usage guidelines on cough recording for valid recording of cough sounds.
  • After completing recording of the cough sound, press submit and in the next screen select “upload” to complete the submission for assessment. You will see a notice “Successfully received the request for assessment.”
  • Wait for a few seconds to see the result of the assessment getting displayed on the screen.

Accessing Reports

  • You can look at consolidated assessments by going to “Records” option from dashboard. 
  • You will notice all assessments in an order with the latest assessment on top.
  • For each entry in the records section, you can access the detailed pdf report. Similarly, you can plot the signal and listen.
  • Please note that a report can be generated only from the cough records tab.

Accessing Informational Report:

  • Go to Dashboard – http://dashboard.swaasa.ai/home to have a detailed view at population level and individual patient level. 
  • Population view provides details on total number of patients scanned and their risk profile.

Individual patient or assessment view provides details on

  • Assessment reports with the symptom’s information collected, vitals, cough sound with an option to play to the sound. You can also find the cough sound characteristics including the duration for the cough record, no.of dry coughs and no.of wet coughs in the record.
  • The output from the device, which includes the detection of underlying respiratory problem, pattern, and its severity. 
  • You can also see a longitudinal view on cough severity, dry cough count and wet cough counts.
  • You can generate a pdf file of the report and take a print as required.
  • You can also provide feedback on the device output with additional comments.   

Instructions for sending a SMS link (Swaasa health check web link) to patient​

  • There is an option for you send an SMS link and request patient to do the self-assessment at home.
  • After patient enrolment or after selecting an existing patient, you can find an option to share the link, selecting this will send an SMS to the patient with Swaasa health check web link information encoded.
  • You can access informational report from the dashboard.

Instructions for self-assessment by patient using Swaasa health check web link

  • Open Swaasa health check web link from the SMS message you have received from your
    doctor.
  • Enter your credentials (mobile number) and complete the validation.
  • Record your cough and provide symptoms for the assessment.
  • Submit data for assessment.
  • After successful completion of assessment, you are notified with your Lung Health Index.
  • For detailed report please reach out to your doctor.

Safety Information

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in patient death or serious impact to the health of patients.

Please follow the mandatory safety information supplied with the Swaasa AI Platform.

Caution

Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate impact to the health of patients.

Operating environment

Instructions for Cough Recording

Instructions for Cleaning Phone

Troubleshooting

If errors in device performance are suspected, the patient should be tested in a hospital or at a
physician office in presence of a Doctor. If performance errors are confirmed, the device should be returned to the company for servicing.

Regulatory Information

Swaasa AI Platform is compliant with following regulations sand standards.

  • License and No objection certificate from CDSCO
  • HIPAA and ISMS certifications