Diamedica Baby CPAP

Target Regions

Africa

Target SDGs

Market Suggested Retail Price

$3,900.00

Target Users (Target Impact Group)

Small and Medium-sized Enterprises

Distributors / Implementing Organizations

Most Baby CPAPs are sold and distributed by Diamedica. Diamedica also has a partner distributor in East Africa, Joh Achelis & Söhne GmbH, that sells the Baby CPAP in Kenya, Tanzania, Uganda, Rwanda, Burundi, and Zambia.

Manufacturing/Building Method

The product is designed and manufactured in the UK.

Intellectural Property Type

Patent Protected

User Provision Model

NGOs typically purchase the Baby CPAP directly from Diamedica. The product is also available for purchase from a partner distributor in East Africa. The distributor typically sells the product to centralized procurement groups within government, private health systems, or church hospitals that subsequently distribute the product to a number of hospitals.Interview with distributor

Distributions to Date Status

Joh Achelis & Söhne GmbH, the East African distributor, has sold approximately 20-50 Diamedica products in the category of CPAP and oxygen concentrators up until 2016.Interview with distributor The quantity of Baby CPAPs distributed by Diamedica is unknown.

Design Specifications

This device generates and delivers a safe, easily controllable mixture of humidified oxygen and air for CPAP treatment. It is driven by an oxygen concentrator that has been modified to produce an increased output with a variable concentration of oxygen. The concentrator has also been modified so that warm waste air from the concentrator's compressor is directed towards the humidifier bottle. The device delivers flows of up to 8L/min of both oxygen and air. An oxygen/air mixing chart is provided with the product which eliminates the need for an oxygen analyzer. The oxygen/air mixture passes over a water humidifier and is delivered to the patient via lightweight respiratory tubing to silicon nasal prongs or a face mask. Pressure in the system is controlled by a bubble bottle that depends on the depth of tubing under water which is set by a simple dial on the bottle top. The Baby CPAP requires time to calibrate before use. A yellow light will turn on after turning on the concentrator. This light will not turn off until the concentration of the gas supply reaches or exceeds 85%, indicating that the concentrator is working properly and ready for use. The CPAP circuit (inspiratory and expiratory limb, bottle and lid and connections) should be cleaned after every patient or weekly if the same child is using the device for over a week. The circuit should be cleaned with soap before it is disinfected with sodium hypochlorite 0.05% or household bleach that is diluted to 0.05% hypochlorite. The exterior of the oxygen concentrator should be cleaned with a mild disinfecting cleaning agent or a diluted solution of bleach (usually 5.25% sodium hypochlorite). Instructions on how to properly clean the device are provided in the user manual. The Baby CPAP requires approximately 30 minutes of routine cleaning and maintenance each week. Dimensions: 39 x 44 x 84 cm; Weight: 26 kg

Product Schematics

Technical Support

Diamedica offers free technical support via email, Skype, or telephone for the lifetime of the product. Diamedica also provides training for medical and technical personnel. Joh Achelis & Söhne GmbH, the East African distributor of the product, has engineers and technicians that provide full in-country technical support.Interview with distributor

Replacement Components

Almost all components in the device can be replaced.

Lifecycle

Unknown.

Manufacturer Specified Performance Parameters

This device is unique in being driven by its own oxygen concentrator which generates oxygen from atmospheric air and thus eliminates the need for expensive cylinders of compressed gases. The Baby CPAP can supply high flows of both compressed air and oxygen at a cost of .11 USD per hour, a fraction of the cost necessary when using oxygen cylinders.Interview with distributor

Vetted Performance Status

A clinical study conducted in Lilongwe, Malawi with 116 children with severe pneumonia reported a survival rate of 64% when the Baby CPAP was used for treatment.

Safety

When setting up the Baby CPAP, make sure that the device is positioned at least 30 cm away from walls and curtains so that the inlet opening is not obstructed. Children that are being treated with CPAP and are clinically stable (have no emergency signs and SpO2 >90%) should be disconnected from CPAP for 10–15 minutes each day in order for nursing staff to determine whether supplemental oxygen and CPAP is still required. The child should be immediately restarted on oxygen if severe hypoxaemia (SpO2 <80%), apnoea or severe respiratory distress occurs while the child is disconnected. Children with acute respiratory disease should not be discharged until their SpO2 has been stable at 90% or more while breathing room air for at least 24 hours, until danger signs have resolved, and until appropriate home treatment can be organized.Interview with distributor

Complementary Technical Systems

A pulse oximeter and a reliable power source are required.

Academic Research and References

Compliance with regulations

CE certified

Evaluation methods

Clinical trials

Other Information

Selected as the runner up for the AAGBI Prize for Innovation in Anaesthesia, Critical Care, and Pain in 2014. Exhibitor at 2016 Geneva Health Forum.