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
  • CSV data output

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

Third Party Accessories [not included]:

  • FDA cleared CPAP / BiPAP mask
  • FDA cleared 22mm respiratory tubing
  • Fisher & Paykel Healthcare HC150
  • Respiratory Humidifier [510(K) number: K003973]

System

Weight 1.76 lb / .8 kg
Dimensions (W x D x H) 4.9 in x 6.9 in x 3.9 in /
12.5 cm x 17.5 cm x 10 cm
Power Requirement 12VDC, 3A [transformer supplied]Operating Range
Operating Range 4 to 20 cm H2O
Operating Temperature 10 to 35 degrees C

Operation

Features

  • 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

Pressures

  • 4 to 20 cm H2O
  • Inspiration and expiration pressures adjustable in 1 cm H2O increments
  • If inspiration pressure equals expiration pressure, nHale™ behaves   as a CPAP machine
  • 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.

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Solutions in Critical Care

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