Phoenix nCPAP 300

The Phoenix CPAP can deliver flow- or bubble-CPAP. It requires purchase of a separate humidifier. It has pressure monitoring via an optional proximal pressure sensor. Pressure is set via flowrate

Category

TPP

Phoenix nCPAP 300

Development Status

n/a

Commercial Product

Types of technology

Bubble or flow

✅ bubble CPAP, flow CPAP

Intended use

To treat respiratory distress and other forms of respiratory illness in infants up to one year of age

✅ A continuous positive airway pressure unit is a device intended to assist infant breathing by delivering a predetermined percentage of oxygen in the breathing air through nasal opening. This unit ls used in hospital environment.

nCPAP is to be used in combination with nCPAP Generator or bubble CPAP kit for breathing with CPAP-Continuous Positive Airway Pressure in combination with the enriching of the inhaling gas mixture with oxygen for applying on humans exclusively for the support of patients with spontaneous breathing.

Continuous positive airway pressure (CPAP) is a treatment in which air is slightly pressurised and provided throughout the breathing cycle. Nasal CPAP (nCPAP) is CPAP provided through the nose. It is used for a range of respiratory conditions in infants, including ve.ry-low-birth-weight infants (VLBWls). It is widely used in neonatology as an alternative to more invasive therapies, intubation and mechanical ventilation.

The nCPAP 300 from Phoenix is an effective system for delivery of NCPAP to neonates and infants. T~is system permits the flow rate, pressure and oxygen concentration of the air provided to the infant to be controlled accurately.

The nCPAP 300 features a user-friendly display and controls. A reliable system of alarms is provided for the utmost safety of the infant.

The nCPAP 300 is very compact and operates quietly.

Size and form factor

n/a

29 cm x 25 cm x 15 cm (control unit only)

Mounting

n/a

Pole mounted

Monitors and maintains therapy setpoints automatically

n/a

Maintains FiO2, monitors pressure

Integrated Heated Humidification

Optimal: Yes

Minimal: None

✅ No – can buy separately

Integrated Device (all-in-one)

n/a

No

Turbine-driven

Integrated on-board air compressor

❌ No

O2 and Air source flexibility

n/a

Requires high pressure O2 and air

Battery backup

Optimal: Rechargeable, >6 hours

Minimal: None

✅ No

Alarms

Optimal: Audio/Visual: Power, Low flow, Low pressure

Minimal: Audio: Power

✅ 1 FiO2 High

2 FiO2 low

3 CPAP high

4 CPAP low

5 Apnea

6 Air input fail

7 Oxygen input

8 Battery low

9 Power fail

Warranty

Optimal: 5 year

Minimal: 1 year

✅ Phoenix nCPAP300 is warranted against manufacturing defects or defective

workmanship for one year from the date of purchase. All consumables and disposable products are guaranteed to be free from defects at the

time of dispatch only. Calibrations are not included in the one year warranty.

During the warranty period any defective parts other than those listed above will be replaced at no charge to the customer. There will be no labour charge for replacing the parts within the state where the first purchase was made.

This warranty is not applicable if

• damage to the unit is caused as a result of mishandling or improper use.
• the customer fails to maintain the unit appropriately.
• the customer uses any parts, accessories or fittings not recommended by Phoenix.
• sale or service is performed by a non-authorized agency.

Phoenix is not liable for incidental or consequential damages including loss of use, property damage or personal injury resulting from breach of warranty.

Incase of failure of electrical components, the service should be carried out by Phoenix-trained service engineers/biomedical engineers

User instructions

Optimal: User manual and additional training materials (checklists, videos, guides) in at least one national official language for the country of intended use. Attached to device with labels and markings where possible

Minimal: User manual provided in at least one national official language

✅ User manual provided

Key features

n/a

Bubble or flow CPAP

Regulatory approvals: FDA (510k approval code), CE Mark, CDSCO (if applicable)

CE, FDA, or other stringent regulator body by a founding member of IMDRF (Japan, Australia, Canada)

✅ CE

Ex-works price of device

Optimal: <$1000

Minimal: <$2000

$4,300 

Landed price of device

Not specified

$7,800 – 9,000

Price of consumables

Optimal: <$10 (exworks)

Minimal: <$15 (exworks)

✅ Compatible with standard consumables

Sales/Market geography

n/a

Mostly India

Inclusion in WHO PQ, other etc

n/a

Nest 360

Manufacturer Indicated Performance: Accuracy, Linear Range, Precision

Oxygen flow 0-10 LPM

5-8 cmH2O

Total flow 0-10 LPM

✅ 21-100%, +-2%

0-15 LPM, +-0.5 LPM

0-20 cmH2O, +-1 cmH2O

Summary of clinical data with link to publications

n/a

n/a

Usability considerations 

n/a

Pressure set via flow control

Required maintenance

n/a

Probably O2 cell replacement every 2 years

Electricity requirements

Optimal: Mains with battery backup. Model must match the voltage and frequency of the purchasing country’s local power grid (e.g., 110-120 VAC at 60 Hz or 220-240 VAC at 50 Hz)

Minimal: Mains without battery backup. Model must match the voltage and frequency of the purchasing country’s local power grid (e.g., 110-120 VAC at 60 Hz or 220-240 VAC at 50 Hz)

✅ 110-230 V, 50-60 Hz, no battery

Evaluation of the product for PHC LMIC use case

Designed for LMIC

Not designed for LMIC