F&P MR850 (bundle)

The F&P humidifier can be paired with a blender, a flow source, and consumables to put together a bubble CPAP system. The MR850 is the gold standard for humidification.

Category

TPP

F&P MR850 (bundle)

Development Status

n/a

Commercial Product

Types of technology

Bubble or flow

✅ bubble CPAP (heated humidifier)

Intended use

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

✅ The MR850 Respiratory Humidifier is used to warm and humidify gases delivered to patients

Size and form factor

n/a

140 mm x 173 mm x 135 mm

2.8 kg (humidifier only)

Mounting

n/a

Individual components, pole mountable

Monitors and maintains therapy setpoints automatically

n/a

Maintains temp only

Integrated Heated Humidification

Optimal: Yes

Minimal: None

✅ Yes

Integrated Device (all-in-one)

n/a

No

Turbine-driven

Integrated on-board air compressor

❌ No

O2 and Air source flexibility

n/a

No

Battery backup

Optimal: Rechargeable, >6 hours

Minimal: None

✅ No

Alarms

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

Minimal: Audio: Power

✅ Alarm Parameters

High Humidity Alarm: An immediate, audible alarm at a displayed temperature of 41 °C or if the airway temperature exceeds 43 °C

Low Humidity Alarm: An audible alarm between 10 minutes @ 29.5 °C, and 60 minutes @ 34.5 °C (Invasive Mode only)

Sound Pressure Level: Alarms exceed 50 dBA @ 1 m

Warranty

Optimal: 5 year

Minimal: 1 year

Unknown

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

Unknown

Key features

n/a

Heated humidification

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, FDA

Ex-works price of device

Optimal: <$1000

Minimal: <$2000

$5,500 

Landed price of device

Not specified

$9,000+

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

None

Manufacturer Indicated Performance: Accuracy, Linear Range, Precision

Oxygen flow 0-10 LPM

5-8 cmH2O

Total flow 0-10 LPM

✅ Invasive Mode

Humidity Performance: ≥ 33 mg/L Flow Range: ≤ 60 L/min Chamber Outlet Control Temperature Range: 35.5 – 42 °C Airway Control Temperature Range: 35 – 40 °C Warm-up Time: < 30 minutes

Non-Invasive Mode

Humidity Performance: ≥ 12 mg/L Flow Range: ≤ 120 L/min Chamber Outlet Control Temperature Range: 31-36 °C Airway Control Temperature Range: 28-34 °C Warm-up Time: < 30 minutes

Recommended Environmental Conditions

Ambient 18 – 26 °C (64.4 – 78.8 °F), 10 – 95% RH, 700 – 1060 hPa Temperature Display Range: 10 – 70 °C Gas Temperature Measurement Accuracy: ± 2 °C (Temperature Probe Accuracy: ± 0.3 °C, in 25 – 45 °C range)

Summary of clinical data with link to publications

n/a

n/a

Usability considerations 

n/a

Requires setting up and connecting separate blender, flow meter, humidifier, and bubble box

Required maintenance

n/a

Little to none

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)

✅ Mains Supply: 115 V~, 60 Hz

Rated Power: 220 VA

Heater-plate Output: 150 W

Heater-wire Output: 22 V~, 2.73 A, 60 W

Evaluation of the product for PHC LMIC use case

Designed for LMIC

Not designed for LMIC