The Pumani bCPAP is a simple bubble CPAP system designed for hospitals in SS Africa. It has a manual blender and uses a pump to pressurize room air to mix with oxygen. It does not have a humidifier and has proprietary consumables.
Development status and timeline
TRL-9: Commercialization and post market studies
Category
TPP
Pumani
Features marked with ✅ meet the Target Product Profile (TPP); ❌ indicates features that do not.
Development Status
n/a
Commercial product, will be pulled from market soon (as of July 2025)
Types of technology
Bubble or flow
✅ bubble CPAP
Intended use
To treat respiratory distress and other forms of respiratory illness in infants up to one year of age
✅ The Pumani bCPAP is intended for use in treating respiratory distress and other forms of respiratory illness in infants up to one year of age/below 10 kg.
Size and form factor
n/a
36 cm x 25 cm x 19 cm
Mounting
n/a
Tabletop
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
Any or no O2 source; generates own air flow
Battery backup
Optimal: Rechargeable, >6 hours
Minimal: None
✅ No
Alarms
Optimal: Audio/Visual: Power, Low flow, Low pressure
Minimal: Audio: Power
✅ Audio alarm: Power loss
Warranty
Optimal: 5 year
Minimal: 1 year
✅ 2 years
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 and additional training materials (checklists, videos, guides)
Key features
n/a
Integrated flow driver
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
✅ $1,000
Landed price of device
Not specified
$2,000
Price of consumables
Optimal: <$10 (exworks)
Minimal: <$15 (exworks)
✅ Proprietary. Inexpensive.
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
✅ Oxygen Blending: 21-90%
Total (blended) Flow Rate: 0-10 L/min
Oxygen Flow Rate: 0-10 L/min
Pressure: 0-10 cm H20
Shipping Weight: 12kg
Accessories: Bottles, Filters
Pumani Patient Circuit Kit - 10 x Complete Patient Circuits including Patient Tubing, Tube Holders, Fish Elbows, Hats & Hat Clips, Nasal Prongs
Summary of clinical data with link to publications
n/a
Usability considerations
n/a
Many infvidual consumable components to put together. Manual oxygen blending requires referring to a chart.
Required maintenance
n/a
Filter change
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)
✅ Voltage: 220V and 50Hz
Power Consumption: 15 W
No battery
Evaluation of the product for PHC LMIC use case
Designed for LMIC
Designed for LMIC
Advantages
Lower cost than some other products. Turbine driven
Limitation
Being pulled from market. No humidification. Proprietary consumables. Cannot support smallest infants. Manual blending. Reports of frequent breakages.