Sleep Apnea diagnostic Device

Chest sensor

Breath sensor

BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from BresoSensor and the pulse oximeter wirelessly, and it stores the data locally. BresoHub is powered by a provided power supply. This device is only sold USA.

Oximeter Medical Tape Strip is used to maintain the proper placement of the Oximeter Reusable Soft Sensor on the finger. In every pack, there are 100 strips.

BresoSensor Frame is a biocompatible component. BresoSensor Frame is a plastic holder with a medical grade adhesive on the patient’s contact side. BresoSensor Frame is used to hold BresoSensor on the suprasternal notch. During a test, BresoSensor Frame is intended to be in contact with the patient’s skin for a maximum period of 8 hours.

Contains BresoSensor Frame (50 units) and BresoTape (100 Units); USA only

Contains Main Kit, Accessory Kit, and Nonin Pulse Oximeter, USA only

Contains BresoHub and BresoSensor; USA Only

BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA.

Sleep quality and sleep disordered breathing detection from pulse oximeters. Marketed as EnsoSleep PPG or Aurora

AirView

Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional.Wesper Lab uses a set of rechargeable, multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a charging pad for recharging, and a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional.The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient.The device’s BLE ports connect to the following:1. Abdominal patch2. Thoracic patch3. Pulse oximeterData from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.

Wesper Lab (“the device”) is a digital recording device designed to collect sleep data in adult patients as prescribed by a healthcare professional.Wesper Lab uses a set of multi-use, adhesive patches that record physiological parameters during sleep. The kit is coupled with a pulse oximeter to collect information about pulse rate and oxygen desaturations. The device employs a mobile application (“the app”), which resides on the patient’s personal mobile device, relaying sleep data wirelessly to a secure remote storage location (“the cloud”) for subsequent analysis by a healthcare professional.The app has 3 Bluetooth Low-Energy (BLE) ports, each of which receives multiple physiological channels from the patient.The device’s BLE ports connect to the following:1. Abdominal patch2. Thoracic patch3. Pulse oximeterData from the patches are transmitted via BLE throughout the night to the app, which uploads the data to the cloud. The third BLE port on the app connects to an authorized FDA-cleared pulse oximeter.This Device Identification is for a kit that is shipped without a charger.

XactTrace Belt 65.6ft/20m

XactTrace Extension Cable Abdomen 78in/200cm

Preemie Airflow Thermistor