RESPIRADOR ASISTIDO

ACCIONADO MEDIANTE FUELLE

Resumen

Requerimientos médicos
Ventilation
Gas and electricity
Infection control
Monitoring and Alarms
Miscellaneous
Unknown Issues

Requerimientos técnicos

Electrónica
Sensores
Firmware

ZONA DE TRABAJO EN SUCIO

Resumen
(Falta un esquema del sistema)

El objetivo de este proyecto es el desarrollo de un aparato para la respiración asistida a

pacientes no críticos que precisan de ayuda para esta función.

El sistema es accionado mediante un motor controlado en lazo cerrado (es decir, el sistema
sabe dónde se encuentra el motor, para detección de fallos). Más información en el
apartado de electrónica y mecánica.

Objetivos
Desarrollar
Requerimientos médicos
(traducido de este ​link​)

Los pacientes con COVID que evolucionan negativamente tienen un fallo de oxigenación, el
denominado ARDS (Acute respiratoria distress syndrome). Tienen problemas para obtener
suficiente oxígeno, no necesariamente tienen problemas para inspirar/exhalar CO2 hacia
dentro/fuera (​revisar esto ultimo​). En un respirador esto significa que se necesita aplicar:
● un valor alto de PEEP (Positive End-Expiratory Pressure) o Presión positiva de fin de
expiración, que es la presión que queda en el pulmón tras la exhalación.
○ Trasladado al diseño esto implica que el sistema tenga la opción de controlar
la presión, al menos durante la expiración (idealmente durante todo el ciclo),
para poder tener Positive end-expiratory pressure (PEEP, is the pressure in
the lungs (alveolar pressure) above atmospheric pressure (the pressure
outside of the body) that exists at the end of expiration.).
● valores altos de tiempo de inspiración
● valores bajos de presión (y de volumen de inspiración) para evitar daños pulmonares
adicionales. (​revisar esto​)

● trigger: el respirador debería detectar que el paciente va a aspirar, y a partir de un

valor de presión (ver inspiratory trigger pressure) debería activas cada ciclo de
respiración.

El hecho de necesitar PEEP implica

Recomendaciones, especificaciones y riesgos de MHRA (​link​)

● Modos de ventilación
○ Modo 1​:​ Ventilación forzada​ (para pacientes profundamente sedados o
paralizados)
■ el usuario (médico) configura un volumen (Tidal Volume) y el output
es un caudal de aire con presión regulada para obtener ese caudal.
En inglés denominan: “pressure regulated volume control (PRVC),
SIMV-PC”

● Modo 2: BIPAP​. Este modo asiste a paciente que son capaces de respirar
por sí mismo pero tienen dificultades.
La presión Positiva de Vía Aérea de dos niveles (Sistema de bipresión
positiva ​BIPAP​) es una forma de soporte respiratorio temporal para
 pacientes que tienen dificultad de respirar. El propósito de la ​BIPAP
es proveer oxígeno y presión, por consiguiente dando facilidades para
que el paciente respire. Cada vez que el paciente respira, la máquina
BIPAP ayuda al paciente aplicando presión del aire para los pulmones
mientras el paciente exhala (exhalación o expiración) para mantener
abiertos los alvéolos pulmonares en los pulmones.

En este caso, el usuario (médico) configura una presión de inspiración

y una presión de expiración. El respirador puede detectar (opción
necesaria de trigger) cuando el paciente comienza a inhalar para
aplicar la presión y caudal de respiración. Después detecta cuando el
paciente comienza a exhalar, en esa fase el respirador tiene que ser
capaz de mantener presión positiva (ver PEEP), aunque menor que la
presión de inhalación.
● Estando en ​Modo 2 - BIPAP​, si el respirador detecta que el paciente dejar de
respirar, debería pasar a ​Modo 1 -​ ​Ventilación forzada

Alguna especificaciones aprobadas por la agencia MHRA de Reino Unido (equivalente a la

FDA) :

Ventilation Parameters:

● Tidal volume: 2~4000ml

● Rate: 1~100 bpm
○ (bpm=breaths per minute = respiraciones por minuto)
● Synchronized intermittent mechanical ventilation (SIMV) rate: 2 ~ 20 bpm
○ (bpm=breaths per minute = respiraciones por minuto)
● Oxygen concentration output: 21% ~ 100% adjustable
● I:E 4:1~1:8
● Inspiratory trigger pressure: -1.0~2.0 kPa
● PEEP: 0 ~ 2.0 kPa
● Pressure range 1.0 ~ 6.0 kPa
● SIGH 0 (off) 1/100 - 5/100
Ventilation Parameters:
1. Tidal volume 2~4000ml
2. Rate 1~100 bpm
○ (bpm=breaths per minute = respiraciones por minuto)
3. Synchronized intermittent mechanical ventilation (SIMV) rate 2 ~ 20 bpm
4. Oxygen concentration output 21% ~ 100% adjustable
5. I:E 4:1~1:8
6. Inspiratory trigger pressure -1.0~2.0 kPa
7. PEEP 0 ~ 2.0 kPa
8. Pressure range 1.0 ~ 6.0 kPa
9. SIGH 0 (off) 1/100 - 5/100

Parameters for ventilation monitoring:

- tidal volume, ventilation volume, IPPV rate, SIMV rate, total respiratory rate, I/E, peak
pressure of airway, pressure - time waveform, flow rate - time waveform, PEEP,
inspiratory trigger pressure

Airway pressure alarm :

- upper limit setting range 1.0~6.0 kPa
- low limit setting range 0.4~2.0 kPa

Per-minute ventilation volume alarm :

- upper limit setting range 3.0~30L/min
- low limit setting range 1.0~10L/min

Sustained high-pressure alarm:

- it will give alarm when stress have consistently been higher than 2.5 kPa

Suffocation alarm :
- it will give sound and light alarm if there is no tidal volume input for 15 seconds

Invasive Ventilation:
Inspiratory tidal volume
Adult 100–4000 ml
Infant 2–350 ml
Inspiratory flow ≤200 l/min
PEEP 0–50 cm H2O
Pressure above PEEP
Adult 0– (120-PEEP) cm H2O
Infant 0 –(80-PEEP) cm H2O

Non-invasive Ventilation:
PEEP 2–20 cm H2O
Pressure above PEEP 0– (62-PEEP) cm H2O
Leakage compensation
Adult Inspiratory, up to 200 l/min
 Adult Expiratory, up to 65 l/min
Infant Inspiratory, up to 33 l/min
Expiratory, up to 25 l/min
Nasal CPAP, up to 20 l/min

Graphical patient data - ​Waveforms graphs: Pressure, Volume, Flow, PCO2 1 , FCO2 ,
Plethysmogram2
Trends 1-, 6-, 12-, 24-, or 72-h trend data for a selected parameter(s)
Cycle data: Pressure/Volume, Pressure/Flow, Volume/Flow, Volume/PCO21 ,
Volume/FCO21
This is a specification of the minimally (and some preferred options) clinically
acceptable ventilator to be used in UK hospitals during the current SARS-CoV2
outbreak. It sets out the clinical requirements based on the consensus of what is
‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive
care medicine professionals and medical device regulators. It is for devices, which
are most likely to confer therapeutic benefit on a patient suffering with ARDS caused
by COVID-19, used in the ​initial care​ of patients requiring urgent ventilation. A
ventilator with lower specifications than this is likely to provide no clinical benefit and
might lead to increased harm, which would be unacceptable for clinicians and would,
therefore, not gain regulatory approval.

It must be borne in mind that intensive care medicine is a whole system of care and
ventilators cannot be safely used on any patient without trained staff and other
equipment and medicines. Where these impinge on the specification they are
mentioned below.

It is proposed these ventilators would be for ​short-term​ stabilisation for a few hours,
but this may be extended up to 1-day use for a patient in extremis as the bare
minimum function. Ideally it would also be able to function as a broader function
ventilator which could support a patient through a number of days, when more
advanced ventilatory support becomes necessary.

Ventilation

1. At least 1, optionally 2 modes of ventilation

a. Must have mandatory ventilation (for the deeply sedated and
paralysed)
The user can set a tidal volume and the output is a pressure regulated flow to
achieve this volume, e.g. pressure regulated volume control (PRVC),
SIMV-PC
b. Optional pressure support mode for those patients breathing to some
extent themselves, e.g. BIPAP. The user sets an inspiratory pressure and
an expiratory pressure. The ventilator can sense when a patient starts to
breathe in and apply the inspiratory pressure, then sense when the patient
starts to breathe out and apply the expiratory pressure (this pressure is
still positive but lower than the inspiratory pressure).
2. If the patient stops breathing in pressure support mode it must failsafe
automatically onto mandatory ventilation.
 3. Inspiratory airway pressure, the higher pressure setting that is applied
to make the patient breathe in:
a. Plateau pressure should adapt to achieve volume and be limited to 35
cmH​2​O.
b. Peak pressure should be no more that 2 cm H​2​O greater than plateau
pressure.
c. Ideally there should be a mechanical failsafe valve that opens at 40
cmH​2​O.
4. Positive End Expiratory Pressure PEEP (usually called EPAP during
pressure support mode). The lower pressure applied to the patients airway to
allow them to breathe out, but not too much.
a. Range 5-25 cm H2O adjustable in 5 cmH​2​O increment.
b. Patient breathing system must remain pressurised to at least the
PEEP level setting at all times.
5. Inspiratory:Expiratory ratio (I:E) (note confusingly it is actually E/I
time). The proportion of each breathing cycle that is spent breathing in compared
to breathing out.
a. 2.0 (i.e. expiration lasts twice as long as inspiration).
b. Optionally adjustable in the range 1.0 – 3.0.
6. Respiratory Rate. The number of breathing cycles every minute.
a. Range 10 – 30 breaths per minute in increments of 2 (only in
mandatory mode) can be set by the user.
7. Tidal Volume (V​t​). The volume of gas flowing into the lungs during one
inspiratory cycle
a. Must have at least one setting of 400ml +/- 10 ml.
b. Ideally 350ml and 450 ml options.
c. Optionally Range 250 – 600 ml in steps of 50ml.
d. Even more optionally up to 800 ml.
e. Optionally the ability to input body weight and have volume calculated
as e.g. 6ml/kg of ideal body weight.

Gas and electricity

1. Incoming Gas Supply.

a. All gas connectors and hoses must use standard non-interchangeable
connectors and be colour coded according to current standards.
 b. Must connect to wall pipeline oxygen supply via Schrader valve
connector (BS 5682, not the bicycle wheel version). If hose not permanently
fixed to machine, then must connect with NIST (Non-Interchangeable Screw
Thread – ISO 10802). Oxygen pipeline pressure is 4-5 Bar.
c. Optionally can incorporate a backup oxygen cylinder connected via
either Schrader valve or Pin Index System.
d. Must be able to be operated on any attached cylinders. Oxygen
cylinder pressure is either 1 – 137 bar if no regulator is fitted, or 4 bar if the
cylinder incorporates a pressure regulator. The ventilator must be able to
work with either. The ventilator must include a pressure regulator to decrease
137 bar cylinder pressure to 4 bar working pressure. Working pressure inside
the ventilator may be upto 4 bar, but it must be impossible to expose the
patient to any pressure above 40 cmH2O.
e. Optionally can connect to wall pipeline medical air via Schrader valve
(NB ‘medical air’ is 4 bar. Must not connect to ‘surgical air 7 bar’ supply).
f. Optionally can connect to Anaesthetic Gas Scavenging System.
g. Optionally can operate using an oxygen concentrator device for input
oxygen.
2. Electricity Supply.
a. Should connect to 240V mains.
b. Battery backup – see unknowns section. Must have 20 minutes back
up battery in case of mains electricity failure.
c. Optionally hot swappable batteries so that it can be run on battery
supply for an extended period, e.g. 2 hours for within hospital transfer.
d. Must avoid harmful RF or EM emissions that could interfere with other
critical machinery.
3. Gas supply to patient.
a. User must be able to control inspired oxygen proportion (FiO​2​). The
percentage of oxygen in the gas being breathed in by the patient. Room air is
21% oxygen.
b. At least 50% and 100% options
c. Very preferably ideally variable between 30 – 100 % in 10% steps.
d. Patient breathing system connections: the ventilator must present
22mm outside diameter (OD) ‘male’ standard connectors for connection to
user supplied 22mm ‘female’ connectors on the breathing system.
4. All elements in the gas pathway must meet biological safety and
oxygen safety standards, especially to minimise risk of fire or contamination of
the patient’s airway
Infection control
1. All parts coming into contact with the patient’s breath must be either
disposable or decontaminatable between patients.
2. All external surfaces must be cleanable in the likely event that they get
respiratory secretions or blood splatter on them. Cleaning would be by healthcare
workers manually wiping using an approved surface wipe with disinfectant or
cloths and approved surface cleaning liquid.
3. There will be a separately sourced HMEF-bacterial-viral filter between
the machine and patient which may impact on resistance within the system,
which may need to be accounted for with some designs. The pressure being
delivered to the patient is the specified pressure. If the filter has a resistance of,
say 2 cmH2O, the ventilator needs to output 37 cmH2O to achieve a set 35
cmH2O at the patient. This will need further detailed consideration. Usually
HMEF filters have negligible resistance, but the viral filtering filters may have
much higher resistance that may be clinically relevant.
4. Optionally include facility for ultrasonic humidifier-warmer to be
included.

Monitoring and Alarms

1. Must alarm at:
a. Gas or electricity supply failure.
b. Machine switched off while in mandatory ventilation mode.
c. Inspiratory airway pressure exceeded.
d. Inspiratory and PEEP pressure not achieved (equivalent to
disconnection alarm).
e. Tidal volume not achieved or exceeded.
2. Monitoring – the following should be continuously displayed so the
user can verify.
a. Current settings of tidal volume, frequency, PEEP, FiO2, ventilation
mode.
b. Actual achieved rates of tidal volume, breathing rate, PEEP, plateau
pressure, FiO​2​.
c. If it exists, in pressure support mode there must be real time
confirmation of each patient breath and an alarm if below acceptable range.
d. Optionally CO​2​ monitoring included.

Miscellaneous
1. Must be reliable. It must have 100% duty cycle for up to 14 days.
2. Optionally it can be used beyond 14 days, the expected durability
must be specified.
3. Can be floor standing.
4. Ideally small and light enough to mount on patient bed and orientation
independent functioning.
5. Should be as robust as possible. For example it may be dropped from
bed height to floor.
6. It must be intuitive to use for qualified medical personnel, but these
may not be specialists in ventilator use.
a. Must not require more than 30 minutes training for a doctor with some
experience of ventilator use.
b. Must include Instructions for Use.
c. Ideally instructions for use should be built into the labelling of the
ventilator, e.g. with ‘connect this to wall’ etc.
d. Must include clear labelling of all critical functions and controls using
standard terms, pictograms and colours that will be readily recognised by UK
healthcare staff.
7. Must have transparent design, supply chain, manufacture and testing
processes that are of sufficient quality to enable MHRA officials to deem
appropriate for usage in exceptional circumstances.
8. Must not be excessively cumbersome so that it would impede hospital
operations or prevent easy movement within hospital premises.
9. Must be made from materials and parts readily available in the UK
supply chain (anticipating increasing global restrictions on freight movement).
10. Standards – there are many standards that exist in this area. Below is
a list of the most relevant ones. They are not formal regulatory requirements but
many are harmonised against regulatory requirements. Consider them as helpful
advisory standards for now. MHRA will lead an exercise to define which can be
‘safely’ relaxed for this emergency situation.
a. BS EN 794-3:1998 +A2:2009 Particular requirements for emergency and
transport ventilators
b. ISO 10651-3:1997 Lung Ventilators for Medical Use - Emergency and
Transport
c. BS ISO 80601-2-84:2018 Medical electrical equipment. Part 2-84. Particular
requirements for basic safety and essential performance of emergency and transport
ventilators – especially the parts on ‘patient gas pathway’ safety (very similar to IEC
60601)
d. BS ISO 19223:2019 Lung ventilators and related equipment. Vocabulary and
semantics
Unknown Issues
1. How plentiful is 4 bar oxygen supply?
a. Absolute minimum oxygen requirement is the human consumption of
about 250 ml/min. However, achieving this is only possible if certain breathing
system designs are used and ‘driving’ gas is done by air.
i. Specifically, would have to use circle
breathing system with active CO2 absorption.
b. If consumption in the range 1-2 l/min is acceptable then a wider range
of designs is possible, but some very basic designs are not.
c. If consumption in the range 10l/min is acceptable then any possible
design can be considered.
2. What is the resistance of HMEF-bacterial-viral filters that are to be
used with the ventilator? Is it clinically relevant?
3. Is there any need to consider running from only low pressure oxygen
e.g. from a concentrator? This makes design more complex.
4. How plentiful is the supply of syringe drivers and drugs for sedation?
a. If limited, then a vaporiser could be used to vaporise Isoflurane for
sedation.
b. This would need certain breathing system designs, mandatory AGSS
and a supply of vaporisers.
5. If monitoring can be done by another machine it could be left out of the
ventilator, but essential parameters must be available to the clinician.
6. Battery backup – Every current ventilator used inside hospitals has a
battery back up, so users will expect it to be there and will behave as if it is, e.g.
unplug it from the wall in order to rearrange cables or while manoeuvring the
patient. However, this needs very careful thought to balance the risks. Including
this in the spec means instantly trying to source 30,000 large, heavy batteries.
Specifying a DC voltage (ie 12VDC) may well be the most sensible for the
machine working voltage. Need the advice of an electronic engineer with
military/resource limited experience before specifying anything here. It needs to
be got right first time.
Requerimientos técnicos
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Electrónica
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Sensores
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Firmware
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Mecánica
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Estructura
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Husillo
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Motores
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ZONA DE TRABAJO EN SUCIO
(Insertar esquema del sistema completo)

Sistemas:
- Fuelle (Coordina Carles)
- Movimiento (Coordina ENRI)
- Electrónica (Coordina fuseprods)
- Sensores (Coordina Antonio Roldán)
- Software (Coordina Alberto Ferrer)

Recapitulemos para orientarnos, añadir lo que se me pase

Fuelle: OK lo coordina Carles
Movimiento: NEMA ¿23? ¿sistema de engranaje al final? lo coordina ENRI con los compis
de IGUS
Válvula unidireccional + PEEP : Celso esta haciendo un diseño de un boceto
Mezclador de Aire-O2: sin explorar aun, VAMOS A DARLE AL COCO
Electrónica: 12v Vs 24v, (parece que mejor 24v) lo coordina fuseprods
Software y Programación:¿? ¿QUIEN SE PUEDE ENCARGAR?
Sensores: se encarga Antonio Roldan
Sensor de presion :honeywell 26PC05SMT
https://www.digikey.es/product-detail/es/honeywell-sensing-and-productivity-s
olutions/26PC05SMT/480-2507-5-ND/1248842
Presion diferencial:+-5psi
Salida Analogica :10V

Documentación: se esta encargando fuseprods pero debería haber mas gente, al menos 1
de cada subgrupo
Resúmenes diarios y gestión de telegram: ¿NECESITO A ALGUIEN QUE RESUMA TODO
LO QUE SE HABLA AQUI? tendría que hacer un mini resumen de lo que sea más
importante y colgarlo de un día para otro. Hacer encuestas y manejar Bots.

Es importante limitar lo que podamos la información que volcamos aquí, ya somos más de
100
No es necesario que lo habléis todo aquí, se genera mucho ruido y todos NO entendemos
de todo.
Cada subgrupo que se coordine y exponga aquí las ideas ya "trilladas" a los demás y entre
todos decidimos. Repartamos trabajo, y evitemos discutir. Si algo crees que no es viable
dilo, pero di porque lo crees y una alternativa si la tienes , o di que no la tienes.
Estoy a vuestra disposición, para dudas de carácter sanitario relacionado con el ventilador y
su uso. Lo que no sepa, lo buscaremos.
Abrid la mente a otros materiales/técnicas, disponemos de gente que se ha ofrecido, que
trabaja diferentes materiales, moldes de silicona, FDM, Resina, CNC,.... Lo mismo para la
electrónica. Pedidme lo que necesitéis para trabajar y yo os lo intento conseguir.
Trabajamos en paralelo con otros grupos y compartimos avances, estamos todos juntos. En
el grupo REESistencia han sacado rápido ese sistema en el que hemos ido aportando ideas
todos (y ahora lo irán mejorando).
En este grupo, más calmadamente, estamos viendo algo más PRO. Es posible que no
lleguemos a nada (yo creo que sí), pero de momento ahí vamos, y estamos avanzando.
El objetivo es conseguir un Ventilador lo suficientemente bueno como para ventilar a un
adulto, de una forma segura, un paciente que no necesite un ventilador “BUENO”, y así
liberar los buenos para la gente que lo va a necesitar.
Aprovecho para daros las gracias por participar, y deciros a todos que, por favor, leáis
mucho, sobre todo a las nuevas incorporaciones, y si es posible que os presentéis, para
saber de dónde sois y que habilidades ofrecéis