Specifications

The BDR-19™ has received Emergency Use Authorization

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Built and Tested for Reliability and Safety

The BreathDirect™ BDR-19™ is produced in adherence to strict medical guidelines and best practices. It was designed to meet FDA 510K standards and protocols specific for ventilators – including 80601-2-80, and 80601-2-12, the standard for critical care ventilators which requires the incorporation of usability and human factors into the design. All stages of product development and production involve facilities and processes certified for the highest levels of quality control and regulatory oversight.

Brochure/Spec Sheet

TECHNICAL SPECIFICATIONS

Monitoring Display with 6 monitoring parameters
Rate, Inspiratory Pressure, MAP, PEEP, Tidal Volume, Minute Volume, Plateau Pressure
Other Display Breath delivered indicator
Alarm indication
Mode selection

PHYSICAL DIMENSIONS

Physical Dimensions

Size:
415mm W x 368mm D x 243mm H

  • 415mm width (measured from outside edge of unit to the outside edge of the exhalation housing)
  • 368mm depth (measured from the circuit connector on front face of the unit to the back edge of units diss fitting nipple)
  • 243mm height (measured from the feet of the unit to top edge of carry handle)

Weight:
11.2KG

Display:
4 lines, 20 characters per line

Main Patient Outlet:
22mm

Oxygen Inlet:
DISS

Air Inlet:
DISS

    ALARMS

    Operator-adjustable High and Low Tidal Volume
    Fixed Alarms Low and High PEEP, Low and High Inspiratory Pressure,
    Rate, Mandatory ventilation in BPAP-S/T mode
    Special Alarms Mains power lost, battery low, battery critically low, loss of internal voltage, loss of gas supply, hardware failure, power off while ventilating, Power On Self-Test, fault, loss of flowrate signal during ventilation
    Speaker Multitonal, High, Medium and Low Priority
    Backup Buzzer Single tone, Hardware fault

    VENTILATION MODES

    Type Description
    Pressure/
    Volume    		 PRVC mode targets a set tidal volume at a set respiratory rate,
    but also responds to a patient’s inspiratory effort
    Pressure PC-CMV mode is a mandatory ventilation mode that delivers
    a set constant pressure at a constant rate to the patient
    Invasive and
    Noninvasive    		 BPAP-S/T mode is a bilevel pressure support mode that supports spontaneous breathing of the patient, and defaults to mandatory ventilation if the patient does not initiate a breath

    STANDARDS

    Designed to these standards,
    certifications pending    		 IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007,
    ISO 80601-2-12:2011 + Cor.:2011, IEC 80601-2-80,
    ISO 5356, ISO 80601-2-74:2017, ISO 10993:2018
    ISO 18562-1:2017, ISO 18562-2:2017, ISO 18562-3:2017
    ISO 18562-4:2017, ISO 62304:2015

    ELECTRICAL & PNEUMATIC SPECIFICATIONS

    Input Voltage 100 to 240 VAC, 50/60 Hz
    Power Consumption (Charging) 34 VA typical, 50VA maximum
    Backup Battery Time 2.5 hours
    Oxygen Supply 40 to 72 psi (276 kPa to 496 kPa) up to 100 L/min max
    Air Supply 40 to 72 psi (276 kPa to 496 kPa) up to 100 L/min max
    Degree of Protection IPX21

    ENVIRONMENT

    Temperature Operating: 50ºF to 95ºF
    (10ºC to 35ºC) 
    Storage: 32ºF to 95ºF
    (0 to 35ºC)
    Humidity 10% to 80% relative humidity non-condensing
    Altitude Operating/Storage/
    Shipping:
    0 to 10,000 ft. (0 to 3,048 m) at Mean Sea Level (MSL)
    under 600 to 1,100hPa of atmospheric pressure

    CONTROL SETTINGS & ADJUSTMENTS

    Setting Range Increments
    PEEP 5 to 25 (cmH2O) 2.5
    Inspiratory Pressure 10 to 50 (cmH2O) 5
    Rate 10 to 40 (BPM) 2
    I:E Ratio 1:1 to 1:3 0.5
    Sensitivity
    (Pressure Trigger)    		  -3 to -0.5 (cmH2O) 0.25
    Tidal Volume 100 to 800 (ml) 50
    Tidal Volume
    Alarm    		 N/A ±50% of setpoint or user
    adjustable in 50 ml increments
    FiO2 21% to 100% 21, 30, 40, 50, 60, 70, 80, 90, 100%

    CONTROLS

    PRVC Mode
    (Blue LED Indicators for active controls)    		 PEEP Setpoint
    Inspiratory Pressure Setpoint
    Rate
    I:E Ratio
    Sensitivity (Pressure Trigger)
    Tidal Volume Target
    PC-CMV
    (Green LED indicators for active controls)    		 PEEP Setpoint
    Inspiratory Pressure Setpoint
    Rate
    I:E Ratio
    Tidal Volume Alarm Limits (Default or User Set)
    BPAP-S/T
    (Amber LED indicators for active controls)    		 PEEP Setpoint
    Inspiratory Pressure Setpoint
    Rate
    I:E Ratio
    Sensitivity (Pressure Trigger)
    Tidal Volume Alarm Limits (Default or User Set)
    15 second Apneic Window (Default setting only)

    BDR-19™ Brochure/Spec Sheet

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