Strados Labs successfully completes pediatric asthma study!

M

Technical Specifications& FAQ

RESP Monitor

Technical Specifications

RESP® Biosensor Specifications
  • Wear Location: Anterior or posterior placement depending on the location of interest.
  • Battery Life: 24+ Hours
  • Dimensions: 3.3” x 2” x .39”
  • Weight: 100g
  • Water Resistant
  • 6 axis MEMS accelerometer
  • Multi-Channel MEMS microphone array
  • Communication: Bluetooth Low Energy
  • Noise Cancellation
  • FDA 510(k) Class II Medical Device
  • CE Mark Class I Device
RESP® Biosensor Measurements
  • Cough
  • Wheeze
  • Rhonchi
  • Crackles
  • Respiratory Rate*
  • Heart Rate*
  • Body Positioning*
  • Sleep/Wake*
  • Activity Levels*

*Measurement not FDA cleared

Security & Privacy
  • HIPAA Compliant
  • Data at rest encrypted
  • Data in transit encrypted
  • PHI safeguards
  • Noise cancellation

Frequently Asked Questions (FAQ)

What is the intended use of the RESP® Biosensor?

The RESP Biosensor is a remote monitoring wearable device intended for demonstrating treatment efficacy in clinical trials as well as remote patient monitoring of at-risk cardiopulmonary patients.

What does the device collect?

The RESP® Biosensor sits on the patient’s chest wall and passively records  patient’s lung sounds including cough, wheeze and crackles. The device also collects motion data to capture respiratory rate*, heart rate*, activity levels*, and body positioning*. 

*Measurement not FDA-cleared

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 RESP Biosensor 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 charging station and connect it to a wall outlet. Next, place the biosensor 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 biosensor is charged, remove it, and press the button to power it on. Pair the biosensor with the mobile device through the Strados app, then create a user account and a patient record.

Disinfect the biosensor then apply it to a patient using the provided 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 with the 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.

Where do I order replacement patient adhesives?

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

How private and secure are patient recordings?

The RESP Biosensor  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.

Let’s Talk.

We’d love to know how we can help you and your patients.