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Dolphin

Dolphin

Innovator
MTTS
Manufacturer
MTTS
image

The Dolphin CPAP is an all-in-one bubble CPAP system with an integrated pulse-oximeter. It is easy to use and robust.

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Development status and timeline

TRL-9: Commercialization and post market studies

Category

TPP

Dolphin

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

Intended use

To treat respiratory distress and other forms of respiratory illness in infants up to one year of age

The Bubble CPAP Therapy provided by the device is indicated for the respiratory support of spontaneously breathing neonatal patients with mild to severe idiopathic respiratory distress syndrome (RDS), mild to severe apnea, atelectasis, hyaline membrane disease (HMD), meconium aspiration syndrome (MAS), transient tachypnea of the neonate (TTN) or lung edema. The device is indicated for use in a hospital setting. The device is not indicated for use with patients whose upper airways have been bypassed.

Size and form factor

n/a

80 cm x 38 cm x 38 cm

18.0 kg

(including trolley)

Mounting

n/a

Trolley mounted

Monitors and maintains therapy setpoints automatically

n/a

Maintains FiO2/temp Monitors pressure

Integrated Heated Humidification

Optimal: Yes

Minimal: None

Yes

Integrated Device (all-in-one)

n/a

Yes

Turbine-driven

Integrated on-board air compressor

Yes

O2 and Air source flexibility

n/a

Any or no O2 source

Battery backup

Optimal: Rechargeable, >6 hours

Minimal: None

Yes

Alarms

Optimal: Audio/Visual: Power, Low flow, Low pressure

Minimal: Audio: Power

Visual /Audible alarms:

  • Power failure
  • Heater wire / temp. sensor failure
  • Input O2 pressure too low / too high
  • Input air pressure too low
  • Flow rate too low / too high
  • Humidifier failure
  • Pressure too high (>14 cmH2O)

Warranty

Optimal: 5 year

Minimal: 1 year

MTTS guarantees that the product that you have purchased or leased from MTTS is free from defects in materials or workmanship under normal use during Limited Warranty Period (period seems to be customer-specific) 

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 pulse-oximetry. All-in-one device. Resuable circuits

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

$3,000 

Landed price of device

Not specified

$4,060 – 6,000

Price of consumables

Optimal: <$10 (exworks)

Minimal: <$15 (exworks)

Reusable

Sales/Market geography

n/a

Mostly SE Asia

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

❌ 4 - 9 L/min

21 - 99 % O2

±5%

Humidifier temp 31.0 - 37.0 °C

±1 °C

Airway temp 35.0 - 40.0 °C

±1 °C

≤10 minutes humidifier warmup

humidifier output

≥33 mg/L

Ambient temperature

+19°C to +37°C

Humidity: 30% to 90% RH non condensing Atmospheric pressure: 70-106kPa

Summary of clinical data with link to publications

n/a

n/a

Usability considerations 

n/a

Very user-friendly

Required maintenance

n/a

Air filter: 6 months

O2 sensor: 18 months

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)

100-240V, 50-60 Hz 240 W maximum, battery backup

Evaluation of the product for PHC LMIC use case

Designed for LMIC

Designed for LMIC

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Advantages

Fully integrated. Alarms

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Limitation

Expensive