NEW BLOG đź“– Unpacking the FDA Advisory Committee Meeting for Merck's Gefapixant

M

Technical Specs & FAQ

Learn more about the Strados Respiratory Care Platform and read our frequently asked questions.

RESP Monitor

Product Description

Strados Respiratory Care Platform and RESP Biosensor

Strados Labs is a respiratory management solutions company that focuses on enabling real-world, real-time monitoring of lung health with smart-sensor technologies. Our proprietary FDA-cleared RESP Biosensor is passive, patient-friendly, and clinically validated to acquire lung sounds in the real world. Patient data is transferred via the cloud to the Strados Clinician Portal which calculates the frequency of wheezing, coughing, shortness of breath as well as respiratory dynamics like rate and excursion for a more holistic picture of each patient.*

*Algorithms and respiratory dynamics not cleared by FDA and for investigational use only

 

Features and Specs

  • Smaller than an iPhone
  • Non-invasive and hands-free
  • FDA 510(k) cleared
  • Able to capture over 24 hours of cough recordings
  • Sleek and lightweight

Product Description

Strados Respiratory Management Solution

Strados Labs is a respiratory management solutions company that focuses on enabling real-world, real-time monitoring of lung health with smart-sensor technologies. Our proprietary FDA-cleared RESP biosensor is passive, patient-friendly, and clinically validated to acquire lung sounds in the real world. Our Strados Cloud platform collects and calculated the frequency of wheezing, coughing, shortness of breath as well as respiratory dynamics like rate and excursion for a more holistic picture of each patient.

Features and Specs

  • Smaller than an iPhone
  • Non-invasive and hands-free
  • FDA 510(k) cleared
  • Able to capture over 24 hours of cough recordings
  • Sleek and lightweight

Frequently Asked Questions

Frequently Asked Questions

What is the intended use of the RESP™ Biosensor?

The RESP Biosensor is a wearable electronic stethoscope intended for the periodic recording of lung sounds. It is intended for medical diagnostic purposes only. It can be used on patients five years of age and older.

What does the device collect?

The RESP Biosensor sits on the patient’s chest wall and passively records the patient’s lung sounds.

Will the RESP™ Biosensor work with my mobile device?

The RESP Biosensor is compatible with Android mobile devices running the Android v5.0 and higher operating systems. It is also compatible with iOS devices.

How does the RESP™ Biosensor communicate with the mobile device?

The RESP Biosensor synchronizes recorded patient data to a mobile device over Bluetooth. Ensure that your mobile device is Bluetooth enabled with v4.1 or higher, and that this functionality is enabled before attempting to use the biosensor.

How do I set up the system?

The Strados RESP is designed for easy setup and use. First, simply un-package the system, and set up the Strados Charging Station on a flat surface at least 1.5m from the patient.  Connect the wall adapter to the Strados Charging Station (SCS) and connect it to a wall outlet. Next, place the Strados Wearable Devices (SWD) into the wireless charging bins.

While charging, download and install the Strados Mobile App from the Google Play store on an Android mobile device. Once the charging station indicates that the SWD is charged, remove it, and press the button to power it on. Pair the SWD with the mobile device through the Strados app, then create a user account and a patient record.

Disinfect the SWD then apply it to a patient using the Strados Patient Adhesive or hold it against the patient by hand. The system is now ready to record. It is important to set up and use the system away from pets and small children. Please refer to the Instructions for Use or the Quick-Start guide for more detailed instructions and additional warnings and precautions before using the system.

How do I create a user account with the Strados™ Mobile App?

A new user can easily create a new account by selecting “Create” on the login screen. The app will guide you through the account creation process, and then ask you to verify the account through your email.

How do I create a patient record with the Strados™ Mobile App?

A user can quickly set up a patient record by tapping the pencil icon next to the patient name on the dashboard screen. The Strados Mobile App will present a list of patients, and an ADD NEW PATIENT button. Select that button and the app will guide you through the rest of the process.

How is the RESP™ Biosensor attached to the patient?

The only way that the device is safely and effectively adhered to the patient is Strados provided patient adhesive. No alternative methods should be attempted. To order additional adhesives, navigate to www.stradoslabs.com or contact us at info@stradoslabs.com

What part of the body is the RESP™ Biosensor applied to?

Strados recommends applying the wearable device to the lower chest cavity as indicated by the instructions for use. A clinician should use a stethoscope prior to application to determine the optimal and appropriate location to monitor lung sounds.

How long will the battery last?

The RESP Biosensor is designed to have a battery life of approximately 24 hours. The device is rechargeable and takes 2-3 hours to fully recharge before the next wear.

Where do I order replacement patient adhesives?

To order additional patient adhesives, contact us at info@stradoslabs.com.

How do I listen to a patient recording?

Once a recording has been made, it will be wirelessly transferred to the mobile device. The patient recording can be listened to after the transfer is complete by accessing the menu icon and selecting the “Recordings” screen. This will list all the recordings for the selected patient in reverse chronological order. Simply select a recording and the triangular play icon to listen to it.

How do I make sure I get the best recording possible?

Strados recommends that all patient recordings be made in an environment that has 60 dBA or less of ambient noise. This means that an ideal environment would be away from TVs, radios, loud groups of people, or other sources of ambient noise. Additionally, all talking should be kept to a minimum while the device is recording.

Will the device record my conversations?

The RESP Biosensor utilizes a microphone, so conversations and other room sounds may be recorded. Additionally, nearby conversations may be recorded as well. The RESP Biosensor will flash an indicator light at the start of a recording. Finally, Strados Labs’ machine learning algorithms* are designed to filter out background noise to isolate patient lung sounds for the most effective clinical use. Regardless, all individuals in the vicinity of the patients should be made aware of the biosensor’s recording capability.

*Algorithms not cleared by FDA and for investigational use only.

How private and secure are patient recordings?

The Strados Respiratory Care Platform is HIPAA compliant. All sensitive patient data is encrypted when stored and transferred between the RESP Biosensor and Strados Mobile App. Patient data can only be accessed and played back from within the app or the Strados Clinician Portal. Furthermore, the Mobile App is designed so that no patient data is user-accessible on the mobile device. Finally, only users with validated accounts and passwords can access recordings.