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NameDescriptionVerification MethodExpected ResultsToleranceTest ResultPassFailTester IDTest DateDevice IDRMVS (Mandatory / Optional - M / O)
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Draft v0.1 - March 25th
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By Public Invention, in cooperation with BreathOfLife and Jonathan Orban
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Licensed under CC0; consider a template to copy and extend
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Copyright Robert L. Read, Juan E Villacres Perez, Nariman Poushin, Jonathan Orban and others 2020
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Note: primary source is UK Rapid Manufactered Ventilator System (1)
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Primary Point of Contact: Robert L. Read, PhD <read.robert@gmail.com>
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Connection
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CON1Electrical connectionInstruct CLI to connect system to ventilatorThey can in 15 seconds< 60 secondsYNM
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CON2Oxygen connectionInstruct CLI to connect O2 supply to ventilatorThey can in 60 seconds< 90 secondsYNM
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CON3Replace BatteriesInstruct CLI to replace batteriesThey can in 5 minutes< 10 minutesYNM
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CON4Endotracheal tube connectionInstruct CLI to connect endotracheal tube (in-situ) to ventilatorThey can in 45 seconds< 60 secondsYNM
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CON5Humidifier connectionInstruct CLI to connect humidifier to ventilatorThey can in 60 seconds< 90 secondsYNO
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CON6Inlet and outlet separated by 10cmMeasure distance.At least 10 cmnoneYNO
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CON7Male inlet and outlet ports provide clearanceCheck inlet and outputs clear in 5cm circle from centerAt least 5cm circlenoneYNM
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StartupYN
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SUP1CLI can tell if powered
Instruct CLI to plug in, ask CLI if it is powered. Instruct CLI to plug into unconnected extension cord. Ask CLI if powered
CLI can correctly tell if poweredYNM
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SUP2Mandatory Mode on Power-UpOn initial power-up, system enters mandatory mode and begins workingMandatory mode operating with respiration rate = DRATE and volume = DVOL andYNM
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SUP3Volume Control begins correct
On power-up, ask CLI what volume is produced, and ask if it is being produced.
CLI answere 400 ml and V produced 400ml10%YNM
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SUP4Respiration Rate StandardOn power-up, check respiration rate, measure total respirations per minute
Respiration rate = DRATE, or persistent Respiration Rate, or match control setting if tied to knobs
1 rpm + 10% of settingYNM
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SUP5I:E ratio corrects
On power-up estimate inspiration and expiration absolute times in tenths of seconds (w/ stopwatch), comptue I:E ratio
I:E ratio = DIERATIO, or remebered setting, or physical settingnoneYNM
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SUP6ModeOn power-up, in mandatory mode, or persistent mode if that is a featureYesnoneYN
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SUP7CLI can locate instruction labelInstruct CLI to locate and inspect instruction labelCLI can correctly locate and read the instruction label in 20 seconds30 secondsYN
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Inspiratory Airway Pressure (Volume Control Mode)
YN
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INSP1IA Pressure limit functionsAsk CLI to adjust IA pressure to 40 cm H2OAfter 120 seconds, IA pressure at most 40cmH20±(2 +(4 % of the actual reading)) cmH2OYNM
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INSP2IA Pressure adjustableAsk CLI to adjust IA pressure to 15, 20, 25, 30, 35 cmH2OAfter each reset, IA pressure limited got configuration (test pressure 60 seconds)YNM
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INSP3IA FailsafeCough, blow, or increase pressure by striking bag representing patientObserve that failsafe valve opens and that pressure does not exceed 80 cm H2O±(2 +(4 % of the actual reading)) cmH2OYNM
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INSP4IA Failsafe, machine cycleRepeat INSP3 on machine min, nominal and max rate and volume settingsObserve that failsafe valve opens and that pressure does not exceed 80 cm H2O±(2 +(4 % of the actual reading)) cmH2OYNM
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PEEP
(PEEP may be implement by separate external valve. Consider separate part to be part of V for purpose of test)
YN
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PEEP1PEEP is understandableAsk CLI to explain how to adjust PEEPThey correctly explainYNM
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PEEP2LOW PEEPAsk CLI to adjust PEEP to 5cmH2OWithin 120 seconds, pressure in airway never drops below 5cmH20±(2 +(4 % of the actual reading)) cmH2OYNM
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PEEP3Incremental PEEPAsk CLI To adjust PEEP to 10, 15, and 20 cmH2OWithin 120 seconds, pressure in airway never drops below 5cmH20±(2 +(4 % of the actual reading)) cmH2OYNM
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Respiration RateYN
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RAT1RateMeasure respirations per minuteMatches DRATE, persistent rate, or physical knobs1 rpm + 10% of settingYNM
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RAT2Up to 30 rpm
Ask CLI to configure machine for 30 rpm. When they are done, measure rpms.
Within 60 seconds, CLI can configure machine to 30 rpm, and V so performs.2 rpmYNM
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RAT3Down to 10 rpm
Ask CLI to configure machine for 10 rpm. When they are done, measure rpms.
Within 60 seconds, CLI can configure machine to 10 rpm, and V so performs.2 rpmYNM
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RAT4Increments
Ask CLI to configure machine to 22 rpm. When they are done, measure rpms.
Within 60 seconds, CLI can configure machine to 22 rpm, and V so performs.2 rpmYNM
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Tidal VolumeYN
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TID1400ml Vt functionsAsk CLI to configure machine to 400ml Tidal Volume (if only setting for machine, ask them to state.) When so set, measure with professional plastic test lung. Observe rise of lung(measured in mm) to match that of forcing 400ml into lung via syringe or other precise method.)400ml ±10%YNM
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TID2Optional 350 and 450ml settingAsk CLI to configure machine to 350ml and 450ml Tidal Volume (if only setting for machine, ask them to state.) When so set, measure with professional plastic test lung. Observe rise of lung(measured in mm) to match that of forcing 400ml into lung via syringe or other precise method.)350ml and 450ml ±10%YNO
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TID3Optional 250 and 600ml rangeAsk CLI to configure machine to extremes of range 250ml and 600ml Tidal Volume (if only setting for machine, ask them to state.) When so set, measure with professional plastic test lung. Observe rise of lung(measured in mm) to match that of forcing 400ml into lung via syringe or other precise method.)250ml and 600ml ±10%YNO
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TID4Highly Optional 800mlAsk CLI to configure machine to extremes of range 800ml Tidal Volume (if only setting for machine, ask them to state.) When so set, measure with professional plastic test lung. Observe rise of lung(measured in mm) to match that of forcing 400ml into lung via syringe or other precise method.)800ml ±10%YNO
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Infection ControlYN
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INFC1
Device can be fully implemented while wearing PPE
Ask CLI to fully connect the system, turn it on, and verify function
CLI can successfuly execute CON1-7 and SUP1-6 while wearing full PPE including hood
YNM
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INFC2Surfaces can be cleanedAsk CLI to disinfect external surfacesWithin 60 seconds, CLI can disinfect external parts of devicenoneYNM
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INFC3HMEF-BV can be changedAsk CLI to change and dispose of HMEFWithin 30 seconds, CLI can remove HMEF and replace itnoneYNM
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INFC4Room air inlet/outlet filter can be changedAsk CLI to change room air inlet/outlet filtersWithin 3 minutes, CLI can change room air inlet/outlet filters<30 secondsYNM
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INFC5ETT can be exchangedAsk CLI to change ETTWithin 30 seconds, CLI can exchange and dispose of ETTnoneYNM
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MonitoringYN
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MON1Vt verifiedAsk CLI to verify and report VtWithin 5 seconds, CLI can report set and actual Vt from monitor<2 secondsYNM
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MON2PEEP verifiedAsk CLI to verify and report PEEPWithin 5 seconds, CLI can report set and achieved PEEP from monitor<2 secondsYNM
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MON3DFiO2 verifiedAsk CLI to verify and report DFiO2Within 5 seconds, CLI can report set and achieved FiO2 from monitor<2 secondsYNM
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MON4Breathing rate verifiedAsk CLI to verify and report breathing rateWithin 5 seconds, CLI can report patient breathing rate<2 secondsYNM
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MON5Airway pressureAsk CLI to verify and report airway pressureWithin 5 seconds, CLI can report airway pressure<2 secondsYNM
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MON6CO2 verifiedAsk CLI to verify and report CO2Within 5 seconds, CLI can report patient expiratory CO2<2 secondsYNO
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MON7Real-time patient breath verifiedAsk CLI to verify and report last patient breathWithin 5 seconds, CLI can report last patient breath in real-time<2 secondsYNM
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MON8I:E ratio verifiedAsk CLI to verify and report I:E ratioWithin 5 seconds, CLI can report set I:E ratio<2 secondsYNO
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MON9Battery life remaining verifiedAsk CLI to verify battery life remainingWithin 5 seconds, CLI can correctly identify battery life<2 secondsYNO
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AlarmYN
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ALA1Device power failureInstruct CLI to cut power to the device without proper shut off protocolAlarm is immediately set offYNM
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ALA2Pressure limit exceeded
Instruct CLI to forcibly add pressure exceeding 80cm H20 whilee blocking failsafe valve
Alarm is set off after 3 seconds<2 secondsYNM
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ALA3Oxygen supply failureInstruct CLI to disconnect oxygen supplyAlarm is set off after 5 seconds<5 secondsYNM
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ALA4Patient breath below acceptable rangeInstruct CLI to block ETTAlarm is set off after 3 seconds<2 secondsYNM
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ALA7PEEP failureInstruct CLI to set PEEP and unplug ETT at end of exhalation cycleAlarm is set off after 2 seconds<1 secondYNM
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ALA8IA pressure failureInstruct CLI to set IA pressure and unplug ETT during inspiration cycleAlarm is set off after 2 seconds<1 secondYNM
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ALA9Vt not achievedYNM
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ALA10Vt exceededYNO
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ALA11Change to battery power
Instruct CLI to cut power to the device, thus switching the device to battery power
Alarm immediately set offYNO
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ALA12Low battery
Instruct CLI to cut power to the device, thus switching the device to battery power, and wait at least 15min.
Alarm is set off<1minYNO
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ALA13Battery power failure
Instruct CLI to cut power to the device, thus switching the device to battery power, and wait for battery power to fail.
Alarm is set offYNM
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Inspiration:Expiration Ratio
YNM
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IER1Inspiratory:Expiratory 1:2 ratio functions
Ask CLI to configure 1:2 I:E (or state the ratio if only available setting). Once set, connect to test lung and verify that inspiratory:expiratory times match a 1:2 second ratio for the set breathing rate.
Timing ratio matches<0.1sYNO
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IER2Inspiratory:Expiratory ratio can be changed
Ask CLI to change I:E ratio by incrementing and decrementing expiratory time (changes of 0.1) from 1:1 to 1:4, and measuring with a test lung. Measure the expiratory time to ensure that I:E ratio matches.
Timing ratio matches<0.1sYN
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Inverse Inspiration:Expiration Ratio
YN
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INVIER1Inspiratory:Expiratory 2:1 ratio functions
Ask CLI to configure 2:1 I:E (or state the ratio if only available setting). Once set, connect to test lung and verify that inspiratory:expiratory times match a 2:1 second ratio for the set breathing rate.
YNO
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INVIER2
Inverse inspiratory:expiratory ratio can be changed
Ask CLI to change I:E ratio by incrementing expiratory time (changes of 0.1) from 2:1 to 10:1, and measuring with a test lung. Measure the expiratory time to ensure that I:E ratio matches.
YNO
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Fraction of Inspired Oxygen
YN
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FIO1FiO2 functions
Ask CLI to configure 50% FiO2, measure with an oxygen sensor, and verify that the values correspond
MatchesYNM
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FIO2FiO2 can be changed
Ask CLI to lower FiO2 to 30%, and increase (10% increments) up to 100%. Verify each step with oxygen sensor.
MatchesYNM
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DurabilityYN
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DUR1Dropped and still functioning
Ask CLI to drop the device from bed height ten times when not in use. Execute CON1-7, SUP1-6, and verify function.
All functions remain.YNM
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DUR2
Dropped while deployed and still functioning
Ask CLI to setup device and from 1.5m ten times. Verify function.All functions remain.YNO
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DUR3
Can be transported in ambulance-type setting
Ask CLI to setup device and vigorously shake for 30seconds.All connections remain.YNO
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DUR4
Can run continously for extended periods of time
Ask TECH to setup device and have it run for 14 days. Continually verify status.
All functions stable throughout timeframe.YNM
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DUR5Connections are robustAsk CLI to connect device and firmly tug each connectionAll connections remain stableYNO
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DUR6Water resistant
Tilt V an angle up to 15 degrees from its normal position and exposed to dripping water for a
duration of 10 minutes and a water flow equivalent to 3mm rainfall per minute (IP22)
All functions remainYNO
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LabellingYN
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LABL1Device COVID-19 restrictionAsk CLI to identify label stating use only for COVID-19
CLI can identify and read out loud the label stating "Restricted device for use during COVID-19 pandemic, only to be used for emergency ventilation" within 20 seconds
<10 secondsYNM
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LABL2Functions and controls easily identifiedAsk CLI to identify all controls and functions on deviceCLI can correctly identify all controls and functions of the device in 1min<20 secondsYNM
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LABL3Breathing inlet and outlet easily identifiedAsk CLI to identify breathing inlet/outletCLI can correctly identify inlet/outlet label within 20 seconds<10 secondsYNM
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LABL4Manual backup label easily identified
Ask CLI to identify label stating "Manual Back Up Ventilation Must Be Available"
CLI can correctly identify and read label out loud in 20 seconds<10 secondsYNM
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LABL5Default settings easily identifiedAsk CLI to identify and state the default settings based on labelsCLI can correctly identify default settings within 1min<10 secondsYNM
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LABL6
(For transient high-flow device) High flow device label easily identified
Ask CLI to identify the "High-Flow Device" labelCLI can correctly identify label within 20 seconds<10 secondsYNO