Comen NV8 Neonatal Ventilator

The Comen NV8 is a dedicated non-invasive neonatal ventilator engineered for newborns, premature infants, and low-birth-weight babies, including those weighing as little as 500 g. It brings together NCPAP, NIPPV, SNIPPV (with backup ventilation), and HFNC modes in a single device, with Peak Inspiratory Pressure (PIP) reaching up to 20 cmH₂O—a pressure range designed to support non-invasive respiratory care while reducing reliance on tracheal intubation.

The NV8’s iFlow intelligent closed-loop control system continuously monitors airway pressure near the infant’s nose and compensates for gas leakage in real time, supporting stable pressure delivery even during high-flow ventilation. The abdominal respiratory sensor triggers apnea wake-up in NCPAP mode and supports SNIPPV synchronization accuracy exceeding 90% across 10 sensitivity levels, directly addressing the irregular breathing patterns common in premature infants.

The device is built around an 8-inch LED touchscreen with a 15° tilt for ergonomic viewing, and includes dual-CPU monitoring, a 360° visible alarm light, and an intelligent warning system with double confirmation for key parameter settings. A built-in lithium battery provides up to 4 hours of operation during power interruption or intra-hospital transport, and the unit is mounted on an aluminum alloy trolley designed to reduce noise and enhance mobility.

For monitoring, the NV8 supports SpO₂ via Masimo or Nellcor modules and includes online oxygen concentration calibration that operates without interrupting ventilation. The device is compatible with NV Flow / Neo.Flow pressure generators as standard, and also accepts Infant Flow, Infant Flow LP, and Medijet generators to match existing departmental setups.

Regulatory status: The NV8 holds China NMPA registration (国械注准20163541772) as a Class III medical device, valid through January 21, 2026. Comen’s quality management system for neonatal and pediatric ventilators is certified under EU MDR 2017/745 Annex IX by SGS FIMKO (Notified Body 0598), Certificate FI23/1008002, valid from December 23, 2025 to September 5, 2028. No FDA 510(k) clearance specific to the NV8 was identified in the public FDA database during preparation of this page. Availability and cleared claims vary by market; confirm local registration and labeling before purchase.

The NV8 is built for neonatal intensive care units, special care nurseries, and delivery rooms that need a dedicated non-invasive ventilation platform for fragile patients—with the pressure performance, synchronization technology, and transport capability that preterm respiratory support demands.

Key Features & Benefits

Four Non-Invasive Modes in One Device: NCPAP, NIPPV, SNIPPV, and HFNC

The NV8 integrates Nasal Continuous Positive Airway Pressure (NCPAP) , Nasal Intermittent Positive Pressure Ventilation (NIPPV) , Synchronized Nasal Intermittent Positive Pressure Ventilation (SNIPPV) with backup ventilation, and High-Flow Nasal Cannula (HFNC) therapy in a single unit. This mode breadth allows a single device to support a neonatal patient from initial non-invasive support through weaning, without requiring separate machines for each modality. The SNIPPV mode includes backup ventilation, and HFNC includes pressure monitoring—configurations intended to support continuity of care as the infant’s respiratory status evolves.

PIP up to 20 cmH₂O with iFlow Closed-Loop Pressure Control

The NV8 delivers Peak Inspiratory Pressure up to 20 cmH₂O, a pressure ceiling positioned to support effective non-invasive ventilation in newborns without escalating to invasive support. The iFlow closed-loop control system uses proximal pressure monitoring near the infant’s nose, feeding data back to the CPU for real-time pressure adjustment and leak compensation—supporting stable pressure delivery even when circuit leakage is present or during high-flow ventilation. The device also includes automatic leakage compensation as a standard function.

Abdominal Respiratory Sensor with Apnea Wake-Up and >90% Synchronization

Premature infants frequently exhibit irregular abdominal breathing and apnea. The NV8 addresses this with an abdominal respiratory sensor that monitors breathing patterns and triggers an apnea wake-up function in NCPAP mode—delivering a strong airflow during detected apnea events. In SNIPPV mode, the sensor supports synchronization with 10 sensitivity levels, achieving breathing synchronization accuracy exceeding 90% according to Comen. This combination is intended to reduce the incidence of apnea and support patient-ventilator synchrony in spontaneously breathing infants.

8-Inch Touchscreen with 15° Tilt and Dual-CPU Monitoring

The 8-inch LED touchscreen is mounted at a 15° tilt for ergonomic viewing from beside the incubator, with a wide viewing angle intended to support quick parameter checks during rounds. The dual-CPU monitoring architecture provides a secondary processing path for enhanced operational reliability, and the intelligent warning system requires double confirmation when setting key parameters to reduce setting errors. A 360° visible alarm light supports awareness from across the NICU.

Up to 4 Hours of Battery for Transport and Power Interruption

The built-in lithium battery provides up to 4 hours of operation, supporting intra-hospital transport and continuity during power failure without interrupting ventilation. The aluminum alloy trolley is designed for mobility and reduced noise during movement between departments. The NV8 is cleared for use in medical institutions and intra-hospital transport under its China registration.

Broad Pressure Generator Compatibility: NV Flow, Neo.Flow, Infant Flow, Medijet

The NV8 ships standard with NV Flow / Neo.Flow pressure generators, designed for comfort and sealing performance in neonatal interfaces. It is also compatible with Infant Flow, Infant Flow LP, and Medijet generators, allowing departments that have standardized on a particular pressure generator to adopt the NV8 without changing their consumable ecosystem. The device includes multi-size soft silicone nasal plugs, masks, and cotton bonnets suitable for premature infants as small as 500 g.

SpO₂ Monitoring and Online Oxygen Calibration Without Interruption

The NV8 supports SpO₂ monitoring via Masimo or Nellcor modules, providing clinicians with blood oxygen data to assess the effectiveness of non-invasive support. The online oxygen concentration calibration circuit allows the oxygen cell to be calibrated while the NV8 continues ventilating—removing the need to interrupt therapy for routine calibration.

Technical Specifications

Why Choose the Comen NV8?