.. covent_19_spec:

Covent-19 Specification
===================

General Performance
^^^^^^^^^^^^^^^^^^^

.. item:: SR-1

Operation shall support mandatory Ventilation (Primary function / minimum)

.. item:: SR-2

Operation shall support spontaneous Ventilation (Secondary function / design goal)

.. item:: SR-3

Volume Control (Primary function / minimum)

.. item:: SR-4

Pressure Control (Secondary function / design goal) 5-60 +/- 5 cmH2O

.. item:: SR-5

Pressure Support 10-15+/-5 cmH2O; may be either flow- or pressure-triggered (Secondary function / design goal)

.. item:: SR-6

Apnea back-up shall kick in at 30 or 60 seconds (+/-5sec) (Secondary function / design goal)

.. item:: SR-7

flow rate shall > 60 liters per minute

.. item:: SR-8

PEEP Pressure: 5-15 cmH2O in increments of 5 cmH20 (+/-5 cmH2O)

.. item:: SR-9

Inspiratory :Expiratory ratio during Mandatory Ventilation: 1:2, 1:3, and 1:4 options shall be available (click-stop)

.. item:: SR-10

The respiratory rate shall deliver 10-30 breaths per minute in increments of 2 bpm

.. item:: SR-11

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
^^^^^^^^^^^^^^^^^

.. item:: SR-15

All components coming in contact with the patients breath must be disposable OR sterilizable (e.g., autoclavable)

.. item:: SR-16

0.22um or smaller filter shall be on patient inspiration and expiration pathway

.. item:: SR-17

Viral filter must be installed on ventilator inlet gas to allow filtration

.. item:: SR-18

All external surfaces must not degrade with application of standard agents for disinfection (e.g. bleach solution)


Gas
^^^

.. item:: SR-12

Gas connectors shall be compatible with high pressure (~50psi) gas source (i.e., pipeline supply) OR low-flow inlet

.. item:: SR-13

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
^^^^^^^^

.. item:: SR-32

Ventilator shall be powered by 120VAC

.. item:: SR-33

Electrical components shall comply with IEC 60601-1 and IEC 60601-1-2

.. item:: SR-34

None with labeling (primary function)

.. item:: SR-35

Ventilator shall have 1 hour (secondary function / design goal) of battery back - up


Alarms and Monitoring
^^^^^^^^^^^^^^^^^^^^^

.. item:: SR-19

(REMOVE: Inlet Gas (O2)) or Power supply failure shall trigger alarmO2 alarm duplicated by SR-24

.. item:: SR-20

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)

.. item:: SR-21

Alarm shall trigger when apnea (i.e. patient not breathing) on spontaneous mode (secondary)

.. item:: SR-22

Alarm shall trigger when inspiratory and PEEP pressure not achieved (i.e. disconnection)

.. item:: SR-23

Alarm shall trigger when tidal volume not achieved or exceeded (with ~20% tolerance)

.. item:: SR-24

Alarm shall trigger when O2 disconnection occurs

.. item:: SR-25

Alarm Volume shall be  60 to 80 dBA at one meter (+/- 5 dBA)

.. item:: SR-26

Actual Value (TV, RR, PEEP, FiO2, Flow Rate, PIP) shall be monitored


Ventilator Specific Standards
^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

.. item:: SR-27

Vent shall be able the function at </=10,000 ft Altitude

.. item:: SR-28

Durability of the ventilator shall =2,000 hours

.. item:: SR-29

Ventilator shall be compatible with readily available patient circuits, (ISO 5356-1 fittings)

.. item:: SR-30

Ventilator shall comply with FDA Ventilator Guidance Standards (i.e. ISO 80601-2-12)

.. item:: SR-31

Ventilator shall comply with general Medical Device Guidance Standards (e.g. ISO 13485, ISO 14971, ISO 62304, ISO 62366)


Traceability Matrix
===================
.. item-matrix:: Covent-19 Specification to System Requirements
   :source: SR-
   :target: RW-SYS
   :targettitle: System Requirements
   :sourcetitle: Covent-19 Specification
   :type: fulfilled_by