FlowLite CPAP (to be branded as Draeger BabyFlow100) is an all-in one, easy to use flow CPAP device. It has integrated therapy monitoring and automatically controls the delivered temperature, humidity, FiO2, and pressure. It has an extensive list of alarms
Development status and timeline
TRL-4/5
Category
TPP
FlowLite
Features marked with ✅ meet the Target Product Profile (TPP); ❌ indicates features that do not.
Development Status
n/a
Product under development
Types of technology
Bubble or flow
✅ Flow-driven CPAP
Intended use
To treat respiratory distress and other forms of respiratory illness in infants up to one year of age
✅ The Neonatal CPAP Unit is intended for use in the hospital clinical environment with spontaneously breathing patients up to 10 kg requiring noninvasive respiratory support.
Size and form factor
n/a
47 cm x 30 cm x 25 cm
Mounting
n/a
Tabletop or trolley or rail mounted
Monitors and maintains therapy setpoints automatically
n/a
Yes
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, 3 hours
Alarms
Optimal: Audio/Visual: Power, Low flow, Low pressure
Minimal: Audio: Power
✅ Audio/Visual (light bar, graphical depiction, written instructions)
High Pressure alarm
Low Pressure alarm
Occlusion alarm
Ac power disconnected Information
Condensation Information
Low FiO2 Alarm
High FiO2 Alarm
Low temperature alarm
High temperature alarm
Low Battery Alarm
Critically low battery alarm
Temperature Cable Disconnect Alarm
Circuit Heater Disconnect Alarm
Humidifier Chamber Empty Alarm
Device Failure Alarm
High Heater Plate Alarm
Low Heater Plate Alarm
Warranty
Optimal: 5 year
Minimal: 1 year
✅ TBD, 1-2 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 provided in at least one national official language. Text and graphical instructions on screen
Key features
n/a
All in one device. Therapy monitoring
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)
Planned CE, CDSCO, FDA
Ex-works price of device
Optimal: <$1000
Minimal: <$2000
✅ $1,500
Landed price of device
Not specified
$2,800
Price of consumables
Optimal: <$10 (exworks)
Minimal: <$15 (exworks)
✅ Compatible with standard consumables
Sales/Market geography
n/a
Global
Inclusion in WHO PQ, other etc
n/a
TBD
Manufacturer Indicated Performance: Accuracy, Linear Range, Precision
Oxygen flow 0-10 LPM
5-8 cmH2O
Total flow 0-10 LPM
✅ Oxygen Blending: 21-97% ± 5% Pressure: 3-10 cm H20 + 1 cmH2O Chamber Outlet Control Temperature Range: 37 °C Airway Control Temperature Range: 39 °C Warm-up Time: < 30 minutes Gas Temperature Measurement Accuracy: ± 2 °C
Summary of clinical data with link to publications
n/a
n/a
Usability considerations
n/a
Very user-friendly
Required maintenance
n/a
Filter replacement yearly
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, battery backup included
Evaluation of the product for PHC LMIC use case
Designed for LMIC
Not designed for LMIC
Advantages
Fully integrated. Alarms. User friendly
Limitation
Moderately expensive.