Instructions for Use

Introduction

Swaasa® AI Platform is intended used by Doctors / Medical professionals for screening of respiratory diseases or conditions. This screening report is to be interpreted by a qualified healthcare practitioner.

Pre-Use Requirements and Dependencies

Android version 8.0 and above and iOS version 11 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: –46 dBV to –35 dBV (5.0 mV/Pa to 17.8 mV/Pa)
Maximum sound pressure level: 98dB – 120 dB SPL

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.
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.

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.

Instructions for using add-on functionality to detect likely presence of disease*

Swaasa® is enhanced to provide new functionality to detect the likely presence of diseases. This is an add-on functionality available only on subscriptions to
(a) Doctors using Swaasa® Mobile Application and (b) Customers integrating Swaasa using APIs.
When Doctors send patients an SMS link for self-assessment, Doctors can see the Likely presence of disease*. (yes/no/inconclusive) along with the disease risk (low/medium/high) in the Dashboard.
As part of self-assessment patient must provide information on additional symptoms and vitals along with cough sound recording.
Patient will only get notified with Lung Health Index () and must contact a doctor for a detailed report.

*Asthma / COPD / COVID-19 / Pulmonary TB.

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.

Informational report is not meant for treatment or diagnosis to take an immediate action. The report serves only as a diagnostic aid in the assessment of respiratory conditions.
Follow the instructions for cough recording, especially the distance from the phone to the patient, the angle of microphone. Any recording not done by following instructions can result in misdiagnosis.
Do not perform assessments on patients in acute exacerbation, severe breathlessness, recent myocardial infarction or pulmonary embolism (within 4-6 weeks), recent eye or abdominal or brain surgery are not recommended.
Follow instructions on sanitizing and cleaning the mobile device after each assessment.
Taking self assessment at home is for your own well being. Hence it is important that you follow the instructions carefully to get genuine results.
In the interest of your own health and the health of our family and colleagues, it is required that the cough sample recorded is your own cough and not any other person’s.
Keep in mind that the system’s usefulness and effectiveness is dependent on the data submitted and correct answers and authentic cough samples of your own is what will give the most benefit to you and your family members.

Caution

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

Record the cough in a quiet environment. Recording in a noisy or moving condition may result in inaccurate results. Cough sounds recorded in a noisy environment will result in additional recordings. Do not use the Swaasa AI Platform in a moving vehicle or in a noisy environment
While selecting an already existing patient using search, please do verify the details before submitting for assessment.
Please concentrate while conducting the assessment. Do not submit the cough record of one patient with the demographic details of another patient.
Please make sure mobile data is ON or the device is connected to internet.
Make sure data collection, assessment is not getting done using the mobile phone in the vicinity of medical devices used in critical care, ICU.

Operating environment

The device is to be used in a primary health setup (like community health center, public health center, wellness center, subcenter), physician’s office, clinic, hospital, and health camps.
Use in temperatures outside the range of 50°C (122°F) and less than -2°C (28.4°F) should be avoided.
Device is designed to operate at altitudes from sea level up to 2588 meters (8491 feet). Use in altitudes outside the range should be avoided.
Device is intended to be used indoors only. Use in humid environments outside the range of 30%RH to 75%RH, non-condensing, and ambient pressure outside the range of 700hPa to 1060hPa, should be avoided.
The environment must be free of excessive vibrations, and sources of electrical noise.

Instructions for Cough Recording

Find a quiet place. Ensure while recording there is no background noise like wind noise, fan, and other such noises.
Hold the phone with the microphone facing the subject / patient. Maintain a distance of 4-8 inches from the patient's mouth.
Maintain a 90-degree angle with the face.
Please cough multiple times.
Each time take a breath and cough.
Repeat this at least 3 to 4 times or until recording stops.
Please feel free to wear a mask.

Instructions for Cleaning Phone

Use a soft microfibre cloth or disinfectant wipe to clean the phone.
Clean with a damp cloth and soap water for waterproof phones.
Use mobile sanitizers to clean the 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.

Regulatory Information

Swaasa® AI Platform is compliant with following regulations and standards.

Licence to Manufacture for Sale and Distribution of Class B Medical Devices from CDSCO
HIPAA and ISMS certifications
ISO 13485:2016 certification