Comen NV10 Neonatal Ventilator

The Comen NV10 is a dedicated non-invasive neonatal and pediatric ventilator engineered to support fragile lungs from the first breath through acute care phases. It brings together an unusually broad set of non-invasive ventilation modalities—including single-limb nasal high-frequency oscillation (nHFO) , NCPAP with apnea auto-relief, DuoVent, NIPPV, synchronized SNIPPV with backup ventilation, and HFNC with ROX index monitoring—within a single device platform.

What distinguishes the NV10 from conventional neonatal ventilators is its non-invasive high-frequency oscillation capability. Delivered through a single-limb circuit rather than a dual-limb Y-piece configuration, the nHFO mode is designed to reduce dead space and lower the work of breathing, while the diaphragm oscillation mechanism—described by Comen as using friction cancellation, linear amplitude, and a smooth sine wave—is intended to provide quieter and more powerful oscillation for CO₂ elimination and, when used with nitric oxide, for persistent pulmonary hypertension of the newborn (PPHN) support.

The NV10’s leakage compensation system provides up to 100% pressure compensation, maintaining set pressures even when mask seal is compromised—a frequent challenge in neonatal non-invasive ventilation. Dual synchronization sensors (abdominal and pressure) with a unique algorithm are designed to improve patient-ventilator synchrony while minimizing false triggering from the infant’s restlessness. VentGuide consolidates multi-parameter indicators into early warnings for ventilation failure, supporting earlier strategy adjustment.

The 10.4-inch TFT capacitive touchscreen (800 × 600) provides a customizable monitoring dashboard, and the 360° visible alarm indicator supports awareness across the NICU. A 14.4 V, 6700 mAh lithium-ion battery provides up to 360 minutes (6 hours) of runtime under HFNC conditions (FiO₂ 21%, flow 2 L/min), supporting intra-hospital transport and power interruption continuity. The main unit weighs under 14 kg, with a trolley weight under 17 kg.

Regulatory status: The NV10 is covered by China NMPA registration as a Class III medical device for the neonatal/pediatric ventilator category. Comen’s quality management system for Neonatal and Pediatric Ventilators is certified under EU MDR 2017/745 Annex IX (I and III) by SGS FIMKO (Notified Body 0598), Certificate FI23/1008002, valid from December 23, 2025 to September 5, 2028. The NV10 is also registered with the Philippine FDA (CMDR-2022-01182) as a Comen Neonatal Ventilator. No FDA 510(k) clearance specific to the NV10 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 NV10 is built for neonatal intensive care units, high-dependency pediatric settings, and step-down units that need a non-invasive ventilation platform capable of escalating from standard CPAP through high-frequency oscillation without changing devices—addressing the continuum of respiratory support that fragile neonates often require.

Key Features & Benefits

Single-Limb nHFO: Non-Invasive High-Frequency Oscillation Without a Dual-Limb Circuit

The NV10’s most distinctive capability is single-limb nasal high-frequency oscillation (nHFO) . Unlike dual-limb configurations with a Y-piece and doubled tubing cavity, the single-limb setup reduces dead space, which Comen positions as decreasing the patient’s work of breathing. The diaphragm oscillation mechanism—using friction cancellation, linear amplitude, and a smooth sine wave—is described as delivering quieter and more powerful oscillation across clinical scenarios. In non-invasive high-frequency ventilation, Comen cites benefits including enhanced CO₂ elimination and effective PPHN management when used with nitric oxide. NHFO frequency is adjustable from 2 Hz to 20 Hz, with mean airway pressure (MAP) from 1 to 20 cmH₂O in the NHFO parameter range.

Full NIV Suite: NCPAP, DuoVent, NIPPV, SNIPPV + Backup, and HFNC

The NV10’s ventilation mode set covers the full spectrum of non-invasive neonatal support. NCPAP operates with airway pressure from 1 to 15 cmH₂O and includes apnea auto-relief. DuoVent (nasal bi-level positive airway pressure) supports low-pressure levels of 1–15 cmH₂O and high-pressure levels of 2–25 cmH₂O. NIPPV provides nasal intermittent positive pressure ventilation, while SNIPPV adds synchronization and backup ventilation for spontaneous-breathing infants. HFNC supports flow rates from 0.5 to 25 L/min with heated humidification and ROX index monitoring for early detection of therapy failure. This mode breadth allows the NV10 to follow a patient from initial non-invasive support through weaning without device changes.

Up to 100% Leakage Compensation and Dual-Sensor Synchronization

The NV10’s leakage compensation system provides pressure compensation up to 100%, ensuring that set pressures are maintained even under compromised mask seal conditions. For synchronization, the NV10 uses two sensor types—abdominal and pressure—with a unique algorithm. The abdominal sensor is designed for quick response and cost-effectiveness, while the pressure sensor minimizes false activations caused by the newborn’s restlessness; both are non-invasive, reducing patient discomfort. Trigger sensitivity is adjustable across 10 levels (or OFF).

VentGuide: Early Warnings for Ventilation Failure

VentGuide consolidates multiple monitoring parameters into a set of indicators positioned as early warnings for ventilation failure, helping medical staff adjust NIV strategies earlier. Supported indices include S/F ratio (SpO₂/FiO₂), OSI (Oxygen Saturation Index), and respiratory severity (FiO₂ × MAP), each with specified ranges and accuracy tolerances in the monitoring specifications. This is intended to support timely clinical decision-making in the NICU environment.

10.4-Inch Capacitive Touchscreen with Customizable Dashboard

The 10.4-inch TFT capacitive touchscreen (800 × 600 pixels, 15 brightness levels) provides an intuitive interface with a customizable dashboard for monitoring respiratory parameters at all times. The 360° visible dual-color alarm indicator supports awareness from across the clinical area. Connectivity includes VGA video output, RJ45 TCP/IP, two USB ports for data import/export, and RS232 serial communication, supporting integration with data management systems and external displays.

Up to 6 Hours of Battery Runtime for Transport and Power Continuity

The 14.4 V, 6700 mAh lithium-ion battery provides up to 360 minutes of runtime under HFNC conditions (FiO₂ 21%, flow 2 L/min). This supports intra-hospital transport and continuity during power interruption without interrupting ventilation. The main unit weighs under 14 kg, with the trolley under 17 kg, and is mounted on four dual-wheel casters with brakes for mobility within the NICU.

Regulatory Documentation: NMPA Class III, EU MDR QMS, Philippine FDA

The NV10 holds China NMPA registration as a Class III medical device. Comen’s QMS for Neonatal and Pediatric Ventilators is certified under EU MDR 2017/745 Annex IX (I and III) by SGS FIMKO (NB 0598), Certificate FI23/1008002, valid through September 5, 2028. The device is registered with the Philippine FDA (CMDR-2022-01182) . No FDA 510(k) specific to the NV10 was identified; confirm local market access before purchase.

Technical Specifications

Why Choose the Comen NV10?