MTTS Dolphin CPAP

Target Regions

Africa, Central Asia, North Asia, South Asia, Southeast Asia

Target SDGs

Target Users (Target Impact Group)

Community, Small and Medium-sized Enterprises

Distributors / Implementing Organizations

Medical Technology Transfer and Services, national and international distributors, Thrive Networks

Competitive Landscape

Direct competitors include Pumani Bubble Continuous Positive Airway Pressure (bCPAP) Device.

Manufacturing/Building Method

The device is manufactured by MTTS in Hanoi, Vietnam. Interview with representative

Intellectural Property Type

Other

User Provision Model

MTTS has a public-private partnership with Thrive Health’s Newborn Health Program (formerly Breath of Life). Through the Newborn Health Program, Thrive Health and MTTS have partnered with Ministries of Health, national universities, and leading neonatologists across 14 countries to implement sustainable training programs and appropriate medical equipment in low-resource environments to reduce neonatal mortality and morbidity. The device will also be available through the MTTS network of national and international distributors. The device can also be ordered directly from MTTS if there is no local presence. The Dolphin CPAP will be sold to hospitals, NGOs, and local and central governments all over the world.Interview with representative

Distributions to Date Status

Prototype. Not available on the market as yet. The device is anticipated to reach market in May 2017.

Design Specifications

The Dolphin CPAP is an all-in-one CPAP treatment and monitoring device. The design integrates gas mixing, humidification, bubble PEEP/CPAP chamber, air compressor and pulse oximiter components in one unit. The gas mixer electronically blends FiO2. The humidification component is a passover humidifier that automatically refills for up to 3 days of continuous operation. The humidifier takes less than 20 minutes to warm up at room temperature. The integrated diaphragm air compressor eliminates the need for an external air source. Additional performance specifications for each component of the Dolphin CPAP are on the product webpage. The Dolphin CPAP is 100% reusable. Most components of the patient circuit can be autoclaved or chemically disinfected if an autoclave is not available. Unit dimensions (excl. support arm): 38 cm x 38 cm x 80 cm Shipping (boxed) dimensions: 48 cm x 48 cm x 90 cm Net Weight (with air compressor): 15 kg Shipping Weight (with air compressor): 20 kg Operating ambient temp: +19°C to +37°C Operating humidity: 0% to 90% RH non condensing Operating atmospheric pressure: 70-106kPa Transport and storage ambient temp: +10°C to +85°C Transport and storage humidity: 0% to 90% RH non condensing Transport and storage atmospheric pressure: 70-106kPa

Product Schematics

Technical Support

The serviceable parts in the Dolphin CPAP are subject to at least a 1 year warranty. A list of serviceable parts and the duration of the warranty per part are available on the product webpage.

Replacement Components

Serviceable parts can be repaired or replaced by the manufacturer if the part is under warranty. Accessories for the Dolphin CPAP (air compressor, battery pack, gas hose, and mains power cable) can be ordered separately.

Lifecycle

Unknown.

Manufacturer Specified Performance Parameters

Unknown.

Vetted Performance Status

A 12-month pilot program was completed for the MTTS CPAP, the predicate device to the Dolphin CPAP. Results of the pilot program with the predicate device indicated that 24-hour mortality from respiratory distress syndrome was reduced by 75% after the introduction of the device.1 Additionally, a study with 100 infants that compared the effects of MTTS CPAP to an industry standard device showed no significant difference between the outcomes. Vetted performance conducted for the Dolphin CPAP is unknown.

Safety

The Dolphin CPAP is equipped with over voltage / over current protection and a mean time between failure (MTBF) of 100,000 hours.

Complementary Technical Systems

Unknown.

Academic Research and References

Compliance with regulations

EN ISO 13485:2012 (certified quality management system), EN 60601-1:2006/AC2010, EN 60601-1-2:2007/AC2010, EN 60601-1-6: 2010, EN 60601-1-8:2007/AC:2010, EN 60601-2-23: 2000, EN 80601-2-61: 2011, EN 12342:1999/A1:2009, ISO 5356-1:2004, ISO 8185:2007, ISO 10993-5, ANSI/AAMI/EN 60601-1, UL/TUV, Energy star efficiency level V compliant, RoHS 2 compliant

Evaluation methods

Unknown

Other Information

Unknown