AES COVID-19 PCV User manual
COVID-19 PCV VENTILATOR
User Guide and Reference Manual
Jamie Ahmed
AES Technologies
155 Tri County Pkwy
Ste 270
Cincinnati, OH 45246
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COPYRIGHT © 2020 AES TECHNOLOGIES
Contents
Introduction ..................................................................................................................................................2
Foreword & Motivation ............................................................................................................................2
About the AES Technologies COVID-19 PCV Ventilator device.................................................................3
Indications for use.....................................................................................................................................3
General warnings and cautions ................................................................................................................3
The COVID-19 PCV Ventilator device............................................................................................................5
The COVID-19 PCV Ventilator device interface.........................................................................................6
Ventilation settings menu.....................................................................................................................7
Ventilator Fault display.........................................................................................................................7
Using the COVID-19 PCV Ventilator device...................................................................................................8
Using the COVID-19 PCV Ventilator device for the first time...................................................................8
Powering on the device ............................................................................................................................9
Powering off the device............................................................................................................................9
Starting and stopping ventilation .............................................................................................................9
Navigating the user interface....................................................................................................................9
Connecting a single limb circuit with exhalation port ............................................................................10
Connecting a single limb circuit for invasive use ................................................................................10
Attaching a Heat Moisture Exchange (HME) ......................................................................................10
Attaching an antibacterial filter..........................................................................................................10
Adding supplemental oxygen..............................................................................................................11
Connecting the device to mains power ..................................................................................................12
Alarms .........................................................................................................................................................12
Resetting Alarms.....................................................................................................................................12
Testing the alarms...................................................................................................................................13
Troubleshooting..........................................................................................................................................14
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COPYRIGHT © 2020 AES TECHNOLOGIES
Introduction
Foreword & Motivation
The AES Technologies COVID-19 PCV Ventilator device was designed specifically to help address the dire
ventilator shortage due to the COVID-19 Pandemic. As of this writing, on April 1, 2020, New York City is
the current epicenter of this virus, and over 900 deaths were reported in the US within a 24-hour period.
This indicates that the death rate in the US is currently doubling every three days - on par to quickly
outpace even Italy, who was hit extremely hard a couple of weeks prior to the US.
It appears that the aside from the obvious calamity and complete lack of preparedness for such a
widespread catastrophe, the primary mechanisms of death in the COVID-19 Pandemic will likely be due
to:
•ARDS
•Lack of respiratory support (ventilators, respiratory therapists) to combat the influx of ARDS
patients to the ICU
oLack of PPE contributing to dwindling personnel
The shortage of ventilators is a massive dilemma that boils down to a lack of parts/components, and an
inability of the supply chain to address the shortage quickly enough - especially for New York.
Our device was designed to address these shortages. There is a massive supply and supply chain for
CPAP/BiPAP machines prescribed for Sleep Apnea. These machines in their stock form do not have the
capability of functioning as PCV Ventilators (aside from hospital-grade units), but they do have the
necessary electromechanical components to function as such - and are already FDA approved medical
devices. Our conversion kit utilizes the electromechanical components of the existing CPAP/BiPAP
machines, and adds in a closed-loop pressure regulating control system, combined with a therapist-
programmable interface to control ventilator mode (control or support mode), peak pressure, PEEP,
breathing rate (b/min), and Inspiratory:Expiratory ratio (I:E). This converts the device into a PCV
Ventilator capable of supporting up to 35 cmH2O of pressure, and a programmable PEEP with a high
settable limit - with the understanding that ARDS patients need substantial PEEP to maintain alveoli
recruitment and to prevent pneumothorax.
Another chief concern with such a conversion - especially in the case of non-invasive ventilation (NIV) - is
the spread of aerosol or droplets from the open-loop circuits present in these CPAP/BiPAP machines.
We have designed an anti-aerosolization system that utilizes existing standard parts, including
exhalation ports and inline antibacterial/antiviral filters. This ensures that minimal droplets/aerosol
escape the closed-loop system, even in NIV cases (of course, we recommend the added precaution of a
surgical mask over the NIV mask in any case).
Lastly, this design was established to address this need in HIGH VOLUME. Using a small Bill of Materials
(BOM) of very easily obtainable parts (and parts that do not overlap with the existing invasive ventilator
(IV) supply chain), virtually any existing supply of CPAP/BiPAP machines can be converted for immediate
use as a PCV Ventilator.
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About the AES Technologies COVID-19 PCV Ventilator device
The AES Technologies COVID-19 PCV Ventilator device provides mechanical ventilation to both
ventilation dependent and non-dependent patients. It delivers pressure ventilation through a single-
limb circuit, and is compatible with a range of accessories to support specific use cases
WARNING
•Read the entire manual before using the COVID-19 PCV Ventilator device.
•Use the COVID-19 PCV Ventilator device only as directed by a physician or healthcare provider
•Use COVID-19 PCV Ventilator device only for the intended use as described in this manual.
Advice contained in this manual does not supersede instructions given by a physician.
•Install and configure the COVID-19 PCV Ventilator device in accordance with the instructions
provided in this guide.
Indications for use
The AES Technologies COVID-19 PCV Ventilator device provides continuous ventilatory support for
patients who require mechanical ventilation. The COVID-19 PCV Ventilator device is intended to be
used in home and institution/hospital applications for both invasive and non-invasive ventilation.
General warnings and cautions
The following are general warnings and cautions. Further specific warnings, cautions, and notes may
appear next to the relevant instruction(s) in the manual.
A warning alerts you to possible injury.
WARNING
•If you notice any unexplained changes in the performance of the device, if it is making unusual
or harsh sounds, if the device or the power supply are dropped or mishandled discontinue use
and contact your healthcare provider.
•For ventilator-dependent patients, always have alternate ventilation equipment available, such
as a back-up ventilator, manual resuscitator or similar device. Failure to do so may result in
patient injury or death.
•The COVID-19 PCV Ventilator device is a restricted medical device intended for use by qualified,
trained personnel under the direction of a physician. Clinical supervision is required in critical
care/intensive care unit environments.
•Ventilator-dependent patients should be continuously monitored by qualified personnel or
adequately trained caregivers. These personnel and caregivers must be capable of taking the
necessary corrective action in the event of a ventilator alarm or malfunction.
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•The COVID-19 PCV Ventilator device is not intended to be operated by persons (including
children) with reduced physical, sensory or mental capabilities without adequate supervision by
a person responsible for the patient's safety.
•The COVID-19 PCV Ventilator device is not intended to be operated by patients unless they have
been given adequate instruction concerning the operation of the device by a person responsible
for the patient's safety.
•The COVID-19 PCV Ventilator device must not be used in the vicinity of an MRI or diathermy
device.
•The effectiveness of ventilation and alarms should be verified including after any ventilation or
alarm setting change, any change in circuit configuration, or after a change to co-therapy (i.e.
nebulization, oxygen flow, et al.).
•The COVID-19 PCV Ventilator device and AC Power Supply can get hot during operation. To
prevent possible skin damage do not leave the device or AC Power Supply in direct contact with
the patient for extended periods of time.
•The device must not be used at an altitude above 9842 ft (3000 m) or outside the temperature
range of 32–104°F (0–40°C). Using the device outside these conditions can affect device
performance which can result in patient injury or death.
A caution explains special measures for the safe and effective use of the device.
CAUTION
•Repairs and servicing of the device should only be performed by an authorized AES Technologies
service representative.
•The temperature of the airflow for breathing produced by the device can be as much as 43F°
(6°C) higher than the temperature of the room. Caution should be exercised if the room
temperature is warmer than 95°F (35°C).
•Do not expose the device to excessive force, dropping or shaking.
•Dusty environments may affect device performance.
For assistance and reporting of issues associated with the COVID-19 PCV Ventilator device, contact
your Health Care Provider or authorized AES Technologies representative.
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The COVID-19 PCV Ventilator device
The following images describe the components of the COVID-19 PCV Ventilator device.
Description
1
System MODE button
2
Rotary dial & button for user input
3
System MENU button
4
Fault Indicator Light
5
System Display
6
Power supply connection (24V, 10A)
7
Pressure sensing port –connect to patient breathing circuit
8
Ambient sensing port –DO NOT CONNECT
9
RESERVED FOR FUTURE USE
10
RESERVED FOR FUTURE USE
11
Connection terminal to CPAP/BiPAP machine blower motor
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The COVID-19 PCV Ventilator device interface
The interface of the COVID-19 PCV Ventilator device comprises several different features described in
the following images.
Description
1
Current System Mode indicator
2
Peak inspiratory pressure setpoint indicator
3
Average tidal pressure indicator
4
PEEP setpoint indicator
5
Breathing rate setpoint indicator
6
I:E ratio setpoint indicator
7
Realtime pressure plot
8
Realtime pressure indicator
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Ventilation settings menu
Description
1
Menu selection indicator
2
Menu selection item description
3
Menu selection current parameter value
4
Menu selection parameter unit(s), if applicable
Device setting
Unit
Description
Ppeak
cmH2O
Peak inspiratory pressure
PEEP
cmH2O
Positive end expiratory pressure
f total
b/min
Breathing rate
I:E
ratio
Ratio of inspiratory time to expiratory time
Interface
N/A
Patient interface selection –MASK or ET
Ventilator Fault display
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Using the COVID-19 PCV Ventilator device
WARNING
Make sure the area around the device is dry, clean and clear of bedding or clothes or other objects that
could block the air inlet. Blocking the air inlet could lead to patient injury.
CAUTION
•To prevent possible damage to the ventilator, always secure it to its stand or place it on a flat,
stable surface.
•Ensure the device is protected against water if used outdoors
Using the COVID-19 PCV Ventilator device for the first time
When using the COVID-19 PCV Ventilator device for the first time, AES Technologies recommends you
first perform a functional test. A functional test will ensure the device is in proper working order before
starting therapy. Information to assist you in resolving any issues is available in the section.
CAUTION
If any of the following checks fail, contact your Healthcare provider or AES Technologies for assistance.
To perform a functional test:
1. Turn off the device by unplugging the power source from the back of the device.
2. Check the condition of the device and accessories. Inspect the device and all accessories. Damaged
components should not be used.
3. Check the patient circuit setup. Check the integrity of the patient circuit (device and accessories) and that all
connections are secure.
4. Turn on the device and test alarms.
WARNING
If no alarm sounds, do not use the ventilator.
Plug the power source into the back of the device to turn on the device. Check that the alarm
sounds the tri-tone test beeps and the LED for the alarm signal flashes. The device is ready for
use when the Home screen is displayed.
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Powering on the device
To power on the COVID-19 PCV Ventilator device, simply plug the power source into the back of the
device. The device will perform a system check while the logo and splash screen are displayed, followed
by the Home screen.
Powering off the device
The COVID-19 PCV Ventilator device must only be powered off when ventilation is stopped!
To power off the COVID-19 PCV Ventilator device, simply unplug the power source from the back of the
device.
Starting and stopping ventilation
Note: If using the device for the first time, AES Technologies recommends performing a functional test
before starting ventilation. Refer to Using the COVID-19 PCV Ventilator device for the first time.
To start ventilation:
1. Power on the device by plugging the power source into the back of the device (if power is not
already on).
2. Press and hold the green MODE button for at least half a second (500ms). Ventilation is started.
The Mode indicator in the upper-left portion of the screen should now show “C”for control.
3. Add oxygen if required.
To stop ventilation:
Ventilation can be stopped at any time and from any screen.
1. If oxygen is connected, turn off the oxygen.
2. Press and hold the green MODE button for at least half a second (500ms). Ventilation is
stopped. The mode indicator in the upper-left portion of the screen should now show “OFF”.
Navigating the user interface
The COVID-19 PCV Ventilator device features a mode indicator and current ventilation parameter
display as well as real-time pressure waveform on the Home screen, and a ventilation settings menu for
setting ventilator parameters.
To access the ventilation settings menu, press the grey MENU button.
To toggle between active menu selections, press the round dial button. The indicator (“>”) indicates the
current selection.
To toggle between values for the active menu selection, rotate the dial to the left or right to increase or
decrease the value, respectively.
To leave the ventilation settings menu and return to the home screen press the grey MENU button
again.
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Connecting a single limb circuit with exhalation port
Works with either distal or proximal pressure port sensing.
WARNING
•At low pressures, the flow through the mask vents may be inadequate to clear all exhaled gases,
and some rebreathing may occur when using a single limb circuit with exhalation port.
•Ensure that all vent holes at the exhalation port are unobstructed. Ensure the area around the
vent holes is clear of bedding, clothes, or other objects and that the vents holes are not directed
towards the patient.
To connect a single limb circuit with exhalation port:
1. Connect the inspiratory limb to the inspiratory port.
2. Attach any required circuit accessories (i.e., humidifier or filter). Note: Due to the COVID-19
Pandemic, it is HIGHLY recommended to ALWAYS use inline viral/bacterial filters to protect
against virus droplet/aerosol transmission. In the case of Non-invasive masks, it is also
recommended to place a surgical mask over the outside of the mask to provide additional
protection against stray droplets.
3. If using a non-vented mask or tracheostomy connector, attach an exhalation port to the free
end of the air tubing ensuring that the exhalation port is as close as possible to the patient.
4. Attach the patient interface (i.e. mask) to the exhalation port or the free end of the air tubing as
appropriate.
Connecting a single limb circuit for invasive use
For invasive ventilation, since the patient's upper respiratory system is bypassed by an artificial airway
device (for example endotracheal or tracheostomy tube) humidification of the inspired gas is required to
prevent lung injury. It is recommended to use a Heat Moisture Exchange (HME) filter.
Attaching a Heat Moisture Exchange (HME)
HME's are passive humidification systems that retain heat and moisture from the patient's exhaled
gases via an internal membrane. An HME should not be used with active humidification.
WARNING
Only use HMEs that comply with the relevant safety standards, including ISO 9360-1 and ISO 9360-2.
Place the HME between the patient end of the circuit and the patient interface.
Attaching an antibacterial filter
WARNING
•Regularly check the antibacterial filter and expiratory valve for signs of moisture or other
contaminants, particularly during nebulization or humidification. Failure to do so could result in
increased breathing system resistance and/or inaccuracies in sensor measurements.
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•Only use antibacterial filters that comply with the relevant safety standards, including ISO
23328-1 and ISO 23328-2.
CAUTION
The antibacterial filter must be used and replaced according to the manufacturer's specifications.
To attach an antibacterial filter:
1. Fit the antibacterial filter to the inspiratory port of the patient interface (NIV Mask or ET).
2. Connect the air tubing to the other side of the filter.
3. Attach the free end of the air tubing to the device.
WARNING
To prevent the risk of cross-contamination, an antibacterial filter is mandatory if the device is to be used
on multiple patients.
Adding supplemental oxygen
At a fixed rate of supplemental oxygen flow, the inhaled oxygen concentration will vary depending on
the Ventilation mode and settings, patient breathing pattern, mask selection, and leak rate.
WARNING
•Use only medical grade oxygen sources.
•Always ensure that the device is ventilating before the oxygen supply is turned on.
•Oxygen flow must be turned off when the device is not ventilating so that oxygen does not
accumulate within the device enclosure. Explanation: Accumulation of oxygen presents a risk of
fire. This applies to most types of ventilators.
•Oxygen supports combustion. Oxygen must not be used while smoking or in the presence of an
open flame. Only use oxygen in well-ventilated rooms.
•The patient circuit and the oxygen source must be kept at a minimum distance of 2 meters away
from any sources of ignition.
•Monitoring of supplemental oxygen requires the use of an external O2 monitor compliant with
ISO 80601-2-55.
To add supplemental oxygen:
1. Insert one end of the oxygen supply tubing into the supplemental oxygen inlet port connector
(typically located on or near non-invasive mask or endotracheal tube). Be sure oxygen tubing is
securely attached to port fitting.
2. Attach the other end of the oxygen supply tubing to the oxygen supply.
3. Start ventilation
4. Turn on oxygen and adjust (at the oxygen supply) to the prescribed flow rate.
To remove supplemental oxygen:
1. Remove the oxygen port connector from the supplemental oxygen inlet port connector
(typically located on or near non-invasive mask or endotracheal tube).
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Connecting the device to mains power
WARNING
Ensure that the power cord does not pose a tripping or choking hazard.
To connect to mains power:
1. Connect the DC plug of the supplied external power supply unit to the rear of the COVID-19 PCV
Ventilator device.
2. Before connecting the power cord to the external power supply unit, ensure the end of the
connector of the power cord is correctly aligned with the input socket on the power supply unit.
3. Plug the other end of the power cord into the power outlet.
Note: The power cord is equipped with a locking connector. To remove, grasp the power cord housing and
gently press down the retaining tab while pulling the connector from the device. Do not twist its outer housing
or pull on the cord.
Alarms
The COVID-19 PCV Ventilator device activates alarms to alert you to conditions that require attention to
ensure patient safety. When an alarm is activated, the COVID-19 PCV Ventilator device provides both
audible and visual alerts and displays an alarm message in the Alarm display on the Information bar.
As soon as the activation condition is met, the device provides both audible and visual alerts without
delay.
The following list of alarms is ordered by relative importance within priority:
•Total power failure*
•High pressure protection
•Circuit disconnection
•Low Pressure
•Obstruction
•High Pressure
•High leak
•High pressure
•Low PEEP
•High PEEP
•Device overcurrent
* No LED will flash, and no buzzer will sound, during a Total power failure alarm
Resetting Alarms
Resetting an alarm removes that alarm from the Alarm display and the Active alarms screen and turns
off the visual and audible alerts. An active alarm should only be reset after the situation that caused the
alarm has been attended to. If the alarm condition has not been corrected, the alarm will activate again.
To reset alarms:
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Once an alarm event has been raised, power to the blower motor is cut off until the device is placed into
the OFF mode by pressing and holding the green MODE button for about half a second (~500ms) and
then ventilation is resumed normally by placing the device into run mode by once again pressing and
holding the green MODE button for about half a second (~500ms).
Testing the alarms
WARNING
Do not perform alarm tests while the patient is connected to the ventilator.
This section describes functional tests to allow the user to understand the conditions that can trigger
common alarms.
Alarm
Test procedure
Low pressure
Disconnect patient interface
Obstruction
Obstruct breathing circuit
High leak
Disconnect patient interface
Pressure sensor error
Block ambient pressure sensor port
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Troubleshooting
If there is a problem, contact your care provider or AES Technologies.
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