nHale™

nHale™ provides bi-level positive air pressure to support respiratory therapy for spontaneously breathing adults weighing over 30kg.

nHale™ is a cost-effective, single patient, reusable device that enables clinicians to follow medical protocol for non-invasive ventilation. The clear user interface facilitates respiratory therapy for patients suffering from COVID-19 disease in private homes, traditional healthcare facilities (e.g. hospitals, assisted living facilities, nursing homes), as well as spaces converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university dormitories, motels, etc.

Features:

Small footprint for maximum portability
Adjustable inspiration pressure, expiration pressure, mandatory respiration rate, inspiration period, rise time, and pressure thresholds
nHale™ Monitor software for optional computer-based set-up
nHale™ Mobile App (availability may vary)

Benefits:

Simple design, ease of use
Compact for transport
Authorized for at-home therapy
Authorized for use with supplemental oxygen
Affordable

Includes:

nHale™ device
Power transformer / adapter
USB cable [2.0]
Instructions for Use
nHale™ Monitor software
FDA Cleared 22mm respiratory tubing
Power transformer/adapter
Instructions for Use for Medical Professionals
Instructions for Use of Patients
nHale™ mobile app (availability may vary)
replacement Filter

Third Party Accessories [not included]:

FDA cleared CPAP / Bi-Level PAP mask
Fisher & Paykel Healthcare HC150
Respiratory Humidifier [510(K) number: K003973]

System

Weight	1.76 lb / .8 kg
Dimensions (W x D x H)	5.0 in x 5.5 in x 5.8 in /
	12.7 cm x 14.0 cm x 14.7 cm
Power Requirement	15VDC,4A 12VDC, 3A [transformer supplied]
Operating Range	4 to 20 cm H2O
Operating Temperature	10 to 35 degrees C

Operation

Features

CPAP Mode
Spontaneous Respiration: Pressure changes triggered by patient’s normal respiratory patterns
Mandatory Respiration: Pressure changes occur at a set interval if not triggered by normal respiration
Data output: CSV data file

Pressures

4 to 20 cm H2O
Inspiration and expiration pressures adjustable in 1 cm H2O increments
Inspiration pressure mst be greater than or equal to expiration pressure
Inspiration pressure must be greater than or equal to expiration pressure

Biometrics

Respiration Rate (RR) cycles / minute
IPAP, cm H2O: Actual patient pressure measured at the inspiratory plateau
EPAP, cmH2O: Actual patient pressure measured at the expiratory plateau

Alarms [Configurable on/off]

Types

Failure to achieve therapy pressure
Therapy pressure exceeded
Failure to cycle (detects and alerts failure to change between inspiration and expiration pressures)
General pressure failure (tube disconnect, mask off, blower failure)
Maximum system pressure exceeded (alarm over 22 cm H2O)

nHaleTM has not been FDA cleared or approved;
nHaleTM has been authorized by FDA under an EUA;
nHaleTM is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.