| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | |
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1 | Name | Description | Verification Method | Expected Results | Tolerance | Test Result | Pass | Fail | Tester ID | Test Date | Device ID | RMVS (Mandatory / Optional - M / O) | |||||||||||||
2 | Draft v0.1 - March 25th | ||||||||||||||||||||||||
3 | By Public Invention, in cooperation with BreathOfLife and Jonathan Orban | ||||||||||||||||||||||||
4 | Licensed under CC0; consider a template to copy and extend | ||||||||||||||||||||||||
5 | Copyright Robert L. Read, Juan E Villacres Perez, Nariman Poushin, Jonathan Orban and others 2020 | ||||||||||||||||||||||||
6 | Note: primary source is UK Rapid Manufactered Ventilator System (1) | ||||||||||||||||||||||||
7 | Primary Point of Contact: Robert L. Read, PhD <read.robert@gmail.com> | ||||||||||||||||||||||||
8 | Connection | ||||||||||||||||||||||||
9 | CON1 | Electrical connection | Instruct CLI to connect system to ventilator | They can in 15 seconds | < 60 seconds | Y | N | M | |||||||||||||||||
10 | CON2 | Oxygen connection | Instruct CLI to connect O2 supply to ventilator | They can in 60 seconds | < 90 seconds | Y | N | M | |||||||||||||||||
11 | CON3 | Replace Batteries | Instruct CLI to replace batteries | They can in 5 minutes | < 10 minutes | Y | N | M | |||||||||||||||||
12 | CON4 | Endotracheal tube connection | Instruct CLI to connect endotracheal tube (in-situ) to ventilator | They can in 45 seconds | < 60 seconds | Y | N | M | |||||||||||||||||
13 | CON5 | Humidifier connection | Instruct CLI to connect humidifier to ventilator | They can in 60 seconds | < 90 seconds | Y | N | O | |||||||||||||||||
14 | CON6 | Inlet and outlet separated by 10cm | Measure distance. | At least 10 cm | none | Y | N | O | |||||||||||||||||
15 | CON7 | Male inlet and outlet ports provide clearance | Check inlet and outputs clear in 5cm circle from center | At least 5cm circle | none | Y | N | M | |||||||||||||||||
29 | Startup | Y | N | ||||||||||||||||||||||
30 | SUP1 | CLI 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 powered | Y | N | M | ||||||||||||||||||
31 | SUP2 | Mandatory Mode on Power-Up | On initial power-up, system enters mandatory mode and begins working | Mandatory mode operating with respiration rate = DRATE and volume = DVOL and | Y | N | M | ||||||||||||||||||
32 | SUP3 | Volume 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 400ml | 10% | Y | N | M | |||||||||||||||||
33 | SUP4 | Respiration Rate Standard | On 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 setting | Y | N | M | |||||||||||||||||
34 | SUP5 | I: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 setting | none | Y | N | M | |||||||||||||||||
35 | SUP6 | Mode | On power-up, in mandatory mode, or persistent mode if that is a feature | Yes | none | Y | N | ||||||||||||||||||
36 | SUP7 | CLI can locate instruction label | Instruct CLI to locate and inspect instruction label | CLI can correctly locate and read the instruction label in 20 seconds | 30 seconds | Y | N | ||||||||||||||||||
50 | Inspiratory Airway Pressure (Volume Control Mode) | Y | N | ||||||||||||||||||||||
51 | INSP1 | IA Pressure limit functions | Ask CLI to adjust IA pressure to 40 cm H2O | After 120 seconds, IA pressure at most 40cmH20 | ±(2 +(4 % of the actual reading)) cmH2O | Y | N | M | |||||||||||||||||
52 | INSP2 | IA Pressure adjustable | Ask CLI to adjust IA pressure to 15, 20, 25, 30, 35 cmH2O | After each reset, IA pressure limited got configuration (test pressure 60 seconds) | Y | N | M | ||||||||||||||||||
53 | INSP3 | IA Failsafe | Cough, blow, or increase pressure by striking bag representing patient | Observe that failsafe valve opens and that pressure does not exceed 80 cm H2O | ±(2 +(4 % of the actual reading)) cmH2O | Y | N | M | |||||||||||||||||
54 | INSP4 | IA Failsafe, machine cycle | Repeat INSP3 on machine min, nominal and max rate and volume settings | Observe that failsafe valve opens and that pressure does not exceed 80 cm H2O | ±(2 +(4 % of the actual reading)) cmH2O | Y | N | M | |||||||||||||||||
71 | PEEP | (PEEP may be implement by separate external valve. Consider separate part to be part of V for purpose of test) | Y | N | |||||||||||||||||||||
72 | PEEP1 | PEEP is understandable | Ask CLI to explain how to adjust PEEP | They correctly explain | Y | N | M | ||||||||||||||||||
73 | PEEP2 | LOW PEEP | Ask CLI to adjust PEEP to 5cmH2O | Within 120 seconds, pressure in airway never drops below 5cmH20 | ±(2 +(4 % of the actual reading)) cmH2O | Y | N | M | |||||||||||||||||
74 | PEEP3 | Incremental PEEP | Ask CLI To adjust PEEP to 10, 15, and 20 cmH2O | Within 120 seconds, pressure in airway never drops below 5cmH20 | ±(2 +(4 % of the actual reading)) cmH2O | Y | N | M | |||||||||||||||||
92 | Respiration Rate | Y | N | ||||||||||||||||||||||
93 | RAT1 | Rate | Measure respirations per minute | Matches DRATE, persistent rate, or physical knobs | 1 rpm + 10% of setting | Y | N | M | |||||||||||||||||
94 | RAT2 | Up 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 rpm | Y | N | M | |||||||||||||||||
95 | RAT3 | Down 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 rpm | Y | N | M | |||||||||||||||||
96 | RAT4 | Increments | 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 rpm | Y | N | M | |||||||||||||||||
113 | Tidal Volume | Y | N | ||||||||||||||||||||||
114 | TID1 | 400ml Vt functions | Ask 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% | Y | N | M | |||||||||||||||||
115 | TID2 | Optional 350 and 450ml setting | Ask 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% | Y | N | O | |||||||||||||||||
116 | TID3 | Optional 250 and 600ml range | Ask 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% | Y | N | O | |||||||||||||||||
117 | TID4 | Highly Optional 800ml | Ask 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% | Y | N | O | |||||||||||||||||
134 | Infection Control | Y | N | ||||||||||||||||||||||
135 | 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 | Y | N | M | ||||||||||||||||||
136 | INFC2 | Surfaces can be cleaned | Ask CLI to disinfect external surfaces | Within 60 seconds, CLI can disinfect external parts of device | none | Y | N | M | |||||||||||||||||
137 | INFC3 | HMEF-BV can be changed | Ask CLI to change and dispose of HMEF | Within 30 seconds, CLI can remove HMEF and replace it | none | Y | N | M | |||||||||||||||||
138 | INFC4 | Room air inlet/outlet filter can be changed | Ask CLI to change room air inlet/outlet filters | Within 3 minutes, CLI can change room air inlet/outlet filters | <30 seconds | Y | N | M | |||||||||||||||||
139 | INFC5 | ETT can be exchanged | Ask CLI to change ETT | Within 30 seconds, CLI can exchange and dispose of ETT | none | Y | N | M | |||||||||||||||||
153 | Monitoring | Y | N | ||||||||||||||||||||||
154 | MON1 | Vt verified | Ask CLI to verify and report Vt | Within 5 seconds, CLI can report set and actual Vt from monitor | <2 seconds | Y | N | M | |||||||||||||||||
155 | MON2 | PEEP verified | Ask CLI to verify and report PEEP | Within 5 seconds, CLI can report set and achieved PEEP from monitor | <2 seconds | Y | N | M | |||||||||||||||||
156 | MON3 | DFiO2 verified | Ask CLI to verify and report DFiO2 | Within 5 seconds, CLI can report set and achieved FiO2 from monitor | <2 seconds | Y | N | M | |||||||||||||||||
157 | MON4 | Breathing rate verified | Ask CLI to verify and report breathing rate | Within 5 seconds, CLI can report patient breathing rate | <2 seconds | Y | N | M | |||||||||||||||||
158 | MON5 | Airway pressure | Ask CLI to verify and report airway pressure | Within 5 seconds, CLI can report airway pressure | <2 seconds | Y | N | M | |||||||||||||||||
159 | MON6 | CO2 verified | Ask CLI to verify and report CO2 | Within 5 seconds, CLI can report patient expiratory CO2 | <2 seconds | Y | N | O | |||||||||||||||||
160 | MON7 | Real-time patient breath verified | Ask CLI to verify and report last patient breath | Within 5 seconds, CLI can report last patient breath in real-time | <2 seconds | Y | N | M | |||||||||||||||||
161 | MON8 | I:E ratio verified | Ask CLI to verify and report I:E ratio | Within 5 seconds, CLI can report set I:E ratio | <2 seconds | Y | N | O | |||||||||||||||||
162 | MON9 | Battery life remaining verified | Ask CLI to verify battery life remaining | Within 5 seconds, CLI can correctly identify battery life | <2 seconds | Y | N | O | |||||||||||||||||
174 | Alarm | Y | N | ||||||||||||||||||||||
175 | ALA1 | Device power failure | Instruct CLI to cut power to the device without proper shut off protocol | Alarm is immediately set off | Y | N | M | ||||||||||||||||||
176 | ALA2 | Pressure limit exceeded | Instruct CLI to forcibly add pressure exceeding 80cm H20 whilee blocking failsafe valve | Alarm is set off after 3 seconds | <2 seconds | Y | N | M | |||||||||||||||||
177 | ALA3 | Oxygen supply failure | Instruct CLI to disconnect oxygen supply | Alarm is set off after 5 seconds | <5 seconds | Y | N | M | |||||||||||||||||
178 | ALA4 | Patient breath below acceptable range | Instruct CLI to block ETT | Alarm is set off after 3 seconds | <2 seconds | Y | N | M | |||||||||||||||||
181 | ALA7 | PEEP failure | Instruct CLI to set PEEP and unplug ETT at end of exhalation cycle | Alarm is set off after 2 seconds | <1 second | Y | N | M | |||||||||||||||||
182 | ALA8 | IA pressure failure | Instruct CLI to set IA pressure and unplug ETT during inspiration cycle | Alarm is set off after 2 seconds | <1 second | Y | N | M | |||||||||||||||||
183 | ALA9 | Vt not achieved | Y | N | M | ||||||||||||||||||||
184 | ALA10 | Vt exceeded | Y | N | O | ||||||||||||||||||||
185 | ALA11 | Change to battery power | Instruct CLI to cut power to the device, thus switching the device to battery power | Alarm immediately set off | Y | N | O | ||||||||||||||||||
186 | ALA12 | Low 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 | <1min | Y | N | O | |||||||||||||||||
187 | ALA13 | Battery 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 off | Y | N | M | ||||||||||||||||||
195 | Inspiration:Expiration Ratio | Y | N | M | |||||||||||||||||||||
196 | IER1 | Inspiratory: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 | <0.1s | Y | N | O | |||||||||||||||||
197 | IER2 | Inspiratory: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 | <0.1s | Y | N | ||||||||||||||||||
198 | Inverse Inspiration:Expiration Ratio | Y | N | ||||||||||||||||||||||
199 | INVIER1 | Inspiratory: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. | Y | N | O | |||||||||||||||||||
200 | 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. | Y | N | O | |||||||||||||||||||
201 | Fraction of Inspired Oxygen | Y | N | ||||||||||||||||||||||
202 | FIO1 | FiO2 functions | Ask CLI to configure 50% FiO2, measure with an oxygen sensor, and verify that the values correspond | Matches | Y | N | M | ||||||||||||||||||
203 | FIO2 | FiO2 can be changed | Ask CLI to lower FiO2 to 30%, and increase (10% increments) up to 100%. Verify each step with oxygen sensor. | Matches | Y | N | M | ||||||||||||||||||
222 | Durability | Y | N | ||||||||||||||||||||||
223 | DUR1 | Dropped 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. | Y | N | M | ||||||||||||||||||
224 | DUR2 | Dropped while deployed and still functioning | Ask CLI to setup device and from 1.5m ten times. Verify function. | All functions remain. | Y | N | O | ||||||||||||||||||
225 | DUR3 | Can be transported in ambulance-type setting | Ask CLI to setup device and vigorously shake for 30seconds. | All connections remain. | Y | N | O | ||||||||||||||||||
226 | 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. | Y | N | M | ||||||||||||||||||
227 | DUR5 | Connections are robust | Ask CLI to connect device and firmly tug each connection | All connections remain stable | Y | N | O | ||||||||||||||||||
228 | DUR6 | Water 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 remain | Y | N | O | ||||||||||||||||||
243 | Labelling | Y | N | ||||||||||||||||||||||
244 | LABL1 | Device COVID-19 restriction | Ask 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 seconds | Y | N | M | |||||||||||||||||
245 | LABL2 | Functions and controls easily identified | Ask CLI to identify all controls and functions on device | CLI can correctly identify all controls and functions of the device in 1min | <20 seconds | Y | N | M | |||||||||||||||||
246 | LABL3 | Breathing inlet and outlet easily identified | Ask CLI to identify breathing inlet/outlet | CLI can correctly identify inlet/outlet label within 20 seconds | <10 seconds | Y | N | M | |||||||||||||||||
247 | LABL4 | Manual 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 seconds | Y | N | M | |||||||||||||||||
248 | LABL5 | Default settings easily identified | Ask CLI to identify and state the default settings based on labels | CLI can correctly identify default settings within 1min | <10 seconds | Y | N | M | |||||||||||||||||
249 | LABL6 | (For transient high-flow device) High flow device label easily identified | Ask CLI to identify the "High-Flow Device" label | CLI can correctly identify label within 20 seconds | <10 seconds | Y | N | O |