Covent-19 Specification
General Performance
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Operation shall support mandatory Ventilation (Primary function / minimum)
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Operation shall support spontaneous Ventilation (Secondary function / design goal)
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Volume Control (Primary function / minimum)
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Pressure Control (Secondary function / design goal) 5-60 +/- 5 cmH2O
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Pressure Support 10-15+/-5 cmH2O; may be either flow- or pressure-triggered (Secondary function / design goal)
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Apnea back-up shall kick in at 30 or 60 seconds (+/-5sec) (Secondary function / design goal)
flow rate shall > 60 liters per minute
PEEP Pressure: 5-15 cmH2O in increments of 5 cmH20 (+/-5 cmH2O)
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Inspiratory :Expiratory ratio during Mandatory Ventilation: 1:2, 1:3, and 1:4 options shall be available (click-stop)
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The respiratory rate shall deliver 10-30 breaths per minute in increments of 2 bpm
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Tidal volume options available shall be as following:Option #1: Input height and gender for 6cc/kg TV (+/- 10% or 10mL)Option #2: 350cc (for average woman) and 450cc (for average man) (+/- 10% or 10mL)Option #3: 400cc only (+/- 10% or 10mL)Option #4: 300-600cc adjustable in 100cc increments (+/- 10% or 10mL)
Infection Control
All components coming in contact with the patients breath must be disposable OR sterilizable (e.g., autoclavable)
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0.22um or smaller filter shall be on patient inspiration and expiration pathway
Viral filter must be installed on ventilator inlet gas to allow filtration
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All external surfaces must not degrade with application of standard agents for disinfection (e.g. bleach solution)
Gas
Gas connectors shall be compatible with high pressure (~50psi) gas source (i.e., pipeline supply) OR low-flow inlet
Oxygen delivery options shall be as followingOption #1: FiO2 (21%+10%, 50%+/- 10%, 100% -10%)Option #2: adjustable between room air (21%) and 100% (+/-10%)
Electric
Ventilator shall be powered by 120VAC
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Electrical components shall comply with IEC 60601-1 and IEC 60601-1-2
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None with labeling (primary function)
Ventilator shall have 1 hour (secondary function / design goal) of battery back - up
Alarms and Monitoring
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(REMOVE: Inlet Gas (O2)) or Power supply failure shall trigger alarmO2 alarm duplicated by SR-24
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Alarm shall trigger when inspiratory airway pressure exceeded limits:Pplat <30-35 cmH2OPeak P no more than 2 cmH2O greater than PplatFail-safe valve opens at 60cmH2O (powered or un-powered)
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Alarm shall trigger when apnea (i.e. patient not breathing) on spontaneous mode (secondary)
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Alarm shall trigger when inspiratory and PEEP pressure not achieved (i.e. disconnection)
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Alarm shall trigger when tidal volume not achieved or exceeded (with ~20% tolerance)
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Alarm shall trigger when O2 disconnection occurs
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Alarm Volume shall be 60 to 80 dBA at one meter (+/- 5 dBA)
Actual Value (TV, RR, PEEP, FiO2, Flow Rate, PIP) shall be monitored
Ventilator Specific Standards
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Vent shall be able the function at </=10,000 ft Altitude
Durability of the ventilator shall =2,000 hours
Ventilator shall be compatible with readily available patient circuits, (ISO 5356-1 fittings)
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Ventilator shall comply with FDA Ventilator Guidance Standards (i.e. ISO 80601-2-12)
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Ventilator shall comply with general Medical Device Guidance Standards (e.g. ISO 13485, ISO 14971, ISO 62304, ISO 62366)
Traceability Matrix
Covent-19 Specification to System Requirements
Covent-19 Specification |
System Requirements |
|---|---|