The Diamedica is the only bubble CPAP system integrated into an oxygen concentrator. It has a passive bubble through humidifier which is supposed to be heated by the device exhaust, but the heating is ineffective. The blender is a manual 2-rotameter blender
Development status and timeline
TRL-9: Commercial ization and post market studies
Category
TPP
Diamedica CPAP-20
Features marked with ✅ meet the Target Product Profile (TPP); ❌ indicates features that do not.
Development Status
n/a
Commercial Product
Types of technology
Bubble or flow
✅ bubble CPAP, Oxygen concentrator
Intended use
To treat respiratory distress and other forms of respiratory illness in infants up to one year of age
✅ This device is suitable for use in hospital settings with limited resources or in any field or outreach locations (where a suitable power source is available) and is suitable for neonates and paediatric patients. CPAP 10 for neonates (< 5kg only) and CPAP 20 for neonates and paediatric patients (<20kg) Note: These weights and parameters should be considered by the clinical team as a guideline only. Clinical decisions should be decided by the clinical team on a case by case basis depending on the patient’s condition. The Diamedica Baby CPAP provides effective and efficient non-invasive airway pressure support to neonate and paediatric patients in difficult environments.
Size and form factor
n/a
Weight 19kg
Height 63 cm x Width 35 cm x Depth 31 cm
Mounting
n/a
Free standing
Monitors and maintains therapy setpoints automatically
n/a
No
Integrated Heated Humidification
Optimal: Yes
Minimal: None
✅ No
Integrated Device (all-in-one)
n/a
No
Turbine-driven
Integrated on-board air compressor
✅ Yes
O2 and Air source flexibility
n/a
Yes
Battery backup
Optimal: Rechargeable, >6 hours
Minimal: None
✅ No
Alarms
Optimal: Audio/Visual: Power, Low flow, Low pressure
Minimal: Audio: Power
✅ Visual /Audible alarms:High/Low pressure, Low flow, Low oxygen, Power fail
Warranty
Optimal: 5 year
Minimal: 1 year
Unknown
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
Integrated oxygen concentration
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
✅ $2,000
Landed price of device
Not specified
$4,000
Price of consumables
Optimal: <$10 (exworks)
Minimal: <$15 (exworks)
Proprietary. Unknown cost
Sales/Market geography
n/a
Mostly Africa
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
✅ Flow: Up to 10 LPM O2, Up to 10 LPM Air, 20 LPM combined flow
Delivered Oxygen concentration range (@95% Oxygen) 21% - 95%
Generated Oxygen concentration 93% +3%/-6% @ 10l/min
System pressure relief 310 kPa ±34.5 kPa
Operating environment 41˚F (5˚C) to 95˚F (35˚C) Up to 95% humidity
Storage environment -4º F to 140º F (-20°C to 60°C), up to 95% relative humidity
Bubble bottle:
0 to 10 cm H₂O ± 1.5 cm H₂O to lid set point
Summary of clinical data with link to publications
n/a
n/a
Usability considerations
n/a
Manual oxygen blending requires referring to a chart.
Required maintenance
n/a
Weekly filter washing, sieve bed changes multiple times in life of device
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)
✅ Operating power range
205V – 260V, 50Hz
Power Consumption 670 Watts
No battery
Evaluation of the product for PHC LMIC use case
Designed for LMIC
Designed for LMIC
Advantages
Integrated oxygen concentration
Limitation
No heated humidification, manual blending, limited monitoring