Pumani Bubble Continuous Positive Airway Pressure (bCPAP) Device

Target Regions

Southeast Asia

Target SDGs

Target Users (Target Impact Group)

Community, Small and Medium-sized Enterprises

Distributors / Implementing Organizations

Partners: Rice 360° and the Malawian Ministry of Health, Médecins Sans Frontières (MSF), Save the Children. Distributor: Hadleigh Health Technologies (a subsidiary of 3rd Stone Design, Inc) located in San Rafael, CA.

Regions

Southeast Asia

Manufacturing/Building Method

3rd Stone Design and its subsidiary company, Hadleigh Health Technologies, have licensed the Pumani bCPAP from Rice and manufacture it in the US.Interview withrepresentative

Intellectural Property Type

Patent Protected

User Provision Model

The Pumani bCPAP is sold to individual clinicians, hospitals, and supporting organizations such as Ministries of Health or Non-Governmental Organizations engaged in providing neonatal and pediatric care. Hadleigh Health Technologies is the primary distributor for the system. Purchase inquiries can be submitted here

Distributions to Date Status

The Pumani bCPAP is now commercially available. 639 Pumani units have been distributed to date. The units were disseminated to 27 central and district government hospitals throughout Malawi and has been distributed in 12 countries in Sub-Saharan Africa, Asia and Latin America. Interview with representative The number of hospitals using the device totals to 127.

Design Specifications

The Pumani bCPAP is made of consumer-grade regulators and air pumps and opted for analog flow meters and gravimetric flow tubes, sheet metal casing, a flow generator, and a patient interface. The flow generator provides ambient airflow to the infant, and an optional oxygen port allows caregivers to treat patients with supplemental oxygen. Submersion of one end of the tubing in a bottle of water creates pressure. By increasing the depth of the tube, the caregiver increases the pressure and the production of bubbles. Pressurized flow helps prevent air sac collapse, thereby allowing the infant to breathe easier. Interview with representative

The Pumani is capable of delivering flow from 0 to 10 L/min and pressure from 5-8 cm H2O. Adjusting these settings is achieved by turning a knob or filling a water bottle. The device also has the ability to blend room air with oxygen from a concentrator or oxygen tank.

Dimensions: 48 x 38 x 31cm Weight: 12kg Power consumption: 15 Watts

Product Schematics

Technical Support

BTB and RICE 360 students train the healthcare professionals in the use of the CPAP Pumani. A teaching module, user manual, and repair manual are included with the system HHD provides online training videos, documents and training aids to customers.

HHT also provides electronic and in-person support.

Replacement Components

The system includes a spare parts kit. The pump filter is to be replaced every one to two years and is included with the device.

Lifecycle

Pumani bCPAP is designed to run for years at a time and comes with a 2 year warranty.

Manufacturer Specified Performance Parameters

The Pumani is suggested to provide the same therapeutic pressure as bCPAP systems in the United States.

Pumani is described as:

Low cost
User-friendly
Highly effective
Simple
Adjustable
Durable

Vetted Performance Status

In 2012, results of the Pumani clinical trial conducted at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, showed that use of the Pumani to treat neonatal respiratory distress resulted in 27% absolute improvement in survival, as compared to patients treated with oxygen therapy.

Safety

Common minor bCPAP complications can result such as facial and nasal irritation.

Complementary Technical Systems

Pulse oximeter, respiratory rate timer, oxygen concentrator and suction machine.

Academic Research and References

Compliance with regulations

Hadleigh Health Technologies is an ISO 13485 registered company Pumani bCPAP has received the CE Mark 0120. Interview with representative

Evaluation methods

Pumani CPAP went through Clinical trials