Specifications
The BDR-19™ has received Emergency Use Authorization
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.
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:
Weight: Display: Main Patient Outlet: Oxygen Inlet: Air Inlet: |
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) |
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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) |