MHRA Ventilator requirements for COVID19
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/876167/RMVS001_v3.1.pdf
a.Must have CMV– Continuous Mandatory Ventilation
b.The CMV mode must be either
i.(ideally) Pressure Regulated Volume Control,
or
ii.pressure controlled ventilation (PCV)
or
iii. minimally a volume controlled ventilation (VCV).
c.PRVC/Pressure Controlled -a set pressure is delivered for the period of inspiration and the volume achieved is measured and displayed. Ideally PRVC, an adaptive mode where the tidal volume is set and the lowest possible pressure is delivered to achieve this volume. PCV where the user has to provide the adaptive control to achieve tidal volume is only acceptable if the tidal volume delivered is clearly displayed and the user can set patient specific upper and lower tidal volume alarms to alert to the need to adjust the pressure.
d.Volume Control Ventilation–the user sets a tidal volume and respiratory rate. The tidal volume is delivered during the inspiratory period. Acceptable only if additional pressure limiting controls are available, see Inspiratory Pressure section.
e.Should have a spontaneous breathing pressure support mode for those patients breathing to some extent themselves,e.g. BIPAP or SIMV-PC.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 a pressure support mode is provided the RMVS must fail-safe automatically onto mandatory ventilation if the patient stops breathing in this mode.
3. Inspiratory airway pressure, the higher pressure setting that is applied to make the patient breathe in:
a.Plateau pressure should be adjusted to achieve volume and must be limited to 35 cmH2O by default.It is acceptable if an option to increase this to 70 cmH2O in exceptional circumstances is provided. This must require a positive decision and action by the user
b.Peak pressure should be no more than 2 cmH2O greater than plateau pressure.
c.If volume control ventilation is used, the user must be able to set inspiratory airway pressure limit in the range at least 15 –40 cmH2O in at least increments of 5 cmH2O.
d.There must be a mechanical fail-safe valve that opens at 80 cmH2O.
4.Positive End Expiratory Pressure (PEEP). The pressure maintained in the breathing system during expiration.
a. RMVS must provide a range of 5-20cmH2O adjustable in 5 cmH2O increments.
b.The patient breathing system must remain pressurised to at least the PEEP level setting at all times.
5.Inspiratory: Expiratory ratio (I:E). The proportion of each breathing cycle that is spent breathing in compared to breathing out.
a.RMVS must provide 1:2.0 (i.e. expiration lasts twice as long as inspiration)as the default setting.
b.RMVS could provide adjustable I:E in the range 1:1–1:3.
6.Respiratory Rate.The number of breathing cycles every minute.
a.RMVS must provide a range 10 –30 breaths per minute in increments of 2(only in mandatory mode) that can be set by the user.
7.Tidal Volume (Vt)setting, if provided.The volume of gas flowing into the lungs during one inspiratory cycle
a.Must have at least one setting of 400ml +/-10 ml.
b.Should have350ml and 450ml options.
c.Could have a range 250–600 ml in steps of 50ml.
d.Could have a range up to 800 ml.
a. All gas connectors and hoses must comply with BS EN ISO
5359:2014+A1:2017, ISO 5359:2014/AMD 1:2017 and BS 2050: 1978
Electrical Conductivity.
b. Must connect to wall pipeline oxygen supply via BS 5682:2015 compatible
probes (Schrader). If hose not permanently fixed to machine, then must
connect with NIST (Non-Interchangeable Screw Thread to ISO
18082:2014/AMD 1:2017). Oxygen pipeline pressure is approximately 3.7 – 4.5
bar.
c. Oxygen supply from wall outlets outside of ICU and theatres is limited to approximately 6-10 lpm averaged over the outlets within a ward(HTM_02-01_Part_A). As such, RMVS should provide for a gas reservoir to manage peak
inspiratory flow rates of up to 100 lpm
d. Average oxygen consumption must be no more than 6 lpm. This may be
allowed to increase as greater certainty is gained over oxygen supply.
e. If RMVS connects to wall pipeline Medical Air (MA4, NOT SA7) it must be via
BS 5682:2015 compatible probes.
f. If connection to Anaesthetic Gas Scavenging System or an external activated
charcoal absorber is provided it must comply to ISO 7396-2:2007 (If inhaled
anaesthetic agents are being used).
g. An RMVS may include an oxygen concentrator as the source of oxygen.
Note these will typically be limited to 10 lpm 96% oxygen.
b. Must be PAT tested to the adapted IEC 60601, IEC 62353 standards
c. If electricity is required for functioning, RMVS must have a battery backup of at least 20 minutes in case of mains electricity failure.
d. Could utilise hot swappable batteries so that it can be run on battery supply for an extended period, e.g. 2 hours for within hospital transfer.
e. Must avoid harmful RF or EM emissions that could interfere with other critical care equipment.
b. Must provide a (50% or 60%) and 100% options
c. Should provide control variable between 30 – 100 % in 10% steps.
d. Patient breathing system connections: RMVS must present 22mm outside
diameter (OD) ‘male’ standard connectors to ISO 5356-1:2015 on both outlet
and inlet ports for connection to user supplied 22mm ‘female’ connectors on
the breathing system. These must be rigid and robust (not plastic) and
separated by a minimum of 10 cm between centres to accommodate filter
HMEs.
4.
All elements in the gas pathway must meet biological safety and low-pressure
oxygen safety standards, especially to minimise risk of fire or contamination of the patient’s airway.
everything a ventilator needs to be to treat COVID19
Ventilation
1.Must have at least 1, optionally 2 modes of ventilationa.Must have CMV– Continuous Mandatory Ventilation
b.The CMV mode must be either
i.(ideally) Pressure Regulated Volume Control,
or
ii.pressure controlled ventilation (PCV)
or
iii. minimally a volume controlled ventilation (VCV).
c.PRVC/Pressure Controlled -a set pressure is delivered for the period of inspiration and the volume achieved is measured and displayed. Ideally PRVC, an adaptive mode where the tidal volume is set and the lowest possible pressure is delivered to achieve this volume. PCV where the user has to provide the adaptive control to achieve tidal volume is only acceptable if the tidal volume delivered is clearly displayed and the user can set patient specific upper and lower tidal volume alarms to alert to the need to adjust the pressure.
d.Volume Control Ventilation–the user sets a tidal volume and respiratory rate. The tidal volume is delivered during the inspiratory period. Acceptable only if additional pressure limiting controls are available, see Inspiratory Pressure section.
e.Should have a spontaneous breathing pressure support mode for those patients breathing to some extent themselves,e.g. BIPAP or SIMV-PC.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 a pressure support mode is provided the RMVS must fail-safe automatically onto mandatory ventilation if the patient stops breathing in this mode.
3. Inspiratory airway pressure, the higher pressure setting that is applied to make the patient breathe in:
a.Plateau pressure should be adjusted to achieve volume and must be limited to 35 cmH2O by default.It is acceptable if an option to increase this to 70 cmH2O in exceptional circumstances is provided. This must require a positive decision and action by the user
b.Peak pressure should be no more than 2 cmH2O greater than plateau pressure.
c.If volume control ventilation is used, the user must be able to set inspiratory airway pressure limit in the range at least 15 –40 cmH2O in at least increments of 5 cmH2O.
d.There must be a mechanical fail-safe valve that opens at 80 cmH2O.
4.Positive End Expiratory Pressure (PEEP). The pressure maintained in the breathing system during expiration.
a. RMVS must provide a range of 5-20cmH2O adjustable in 5 cmH2O increments.
b.The patient breathing system must remain pressurised to at least the PEEP level setting at all times.
5.Inspiratory: Expiratory ratio (I:E). The proportion of each breathing cycle that is spent breathing in compared to breathing out.
a.RMVS must provide 1:2.0 (i.e. expiration lasts twice as long as inspiration)as the default setting.
b.RMVS could provide adjustable I:E in the range 1:1–1:3.
6.Respiratory Rate.The number of breathing cycles every minute.
a.RMVS must provide a range 10 –30 breaths per minute in increments of 2(only in mandatory mode) that can be set by the user.
7.Tidal Volume (Vt)setting, if provided.The volume of gas flowing into the lungs during one inspiratory cycle
a.Must have at least one setting of 400ml +/-10 ml.
b.Should have350ml and 450ml options.
c.Could have a range 250–600 ml in steps of 50ml.
d.Could have a range up to 800 ml.
Gas and electricity
1.Incoming Gas Supply.a. All gas connectors and hoses must comply with BS EN ISO
5359:2014+A1:2017, ISO 5359:2014/AMD 1:2017 and BS 2050: 1978
Electrical Conductivity.
b. Must connect to wall pipeline oxygen supply via BS 5682:2015 compatible
probes (Schrader). If hose not permanently fixed to machine, then must
connect with NIST (Non-Interchangeable Screw Thread to ISO
18082:2014/AMD 1:2017). Oxygen pipeline pressure is approximately 3.7 – 4.5
bar.
c. Oxygen supply from wall outlets outside of ICU and theatres is limited to approximately 6-10 lpm averaged over the outlets within a ward(HTM_02-01_Part_A). As such, RMVS should provide for a gas reservoir to manage peak
inspiratory flow rates of up to 100 lpm
d. Average oxygen consumption must be no more than 6 lpm. This may be
allowed to increase as greater certainty is gained over oxygen supply.
e. If RMVS connects to wall pipeline Medical Air (MA4, NOT SA7) it must be via
BS 5682:2015 compatible probes.
f. If connection to Anaesthetic Gas Scavenging System or an external activated
charcoal absorber is provided it must comply to ISO 7396-2:2007 (If inhaled
anaesthetic agents are being used).
g. An RMVS may include an oxygen concentrator as the source of oxygen.
Note these will typically be limited to 10 lpm 96% oxygen.
2. Electricity Supply.
a. If mains powered RMVS must connect to 240V mains via standard UK 3 pin plug.b. Must be PAT tested to the adapted IEC 60601, IEC 62353 standards
c. If electricity is required for functioning, RMVS must have a battery backup of at least 20 minutes in case of mains electricity failure.
d. Could utilise hot swappable batteries so that it can be run on battery supply for an extended period, e.g. 2 hours for within hospital transfer.
e. Must avoid harmful RF or EM emissions that could interfere with other critical care equipment.
3. Gas supply to patient.
a. User must be able to control inspired oxygen proportion (FiO2 ). The percentage of oxygen in the gas being breathed in by the patient. Room air is 21% oxygen.b. Must provide a (50% or 60%) and 100% options
c. Should provide control variable between 30 – 100 % in 10% steps.
d. Patient breathing system connections: RMVS must present 22mm outside
diameter (OD) ‘male’ standard connectors to ISO 5356-1:2015 on both outlet
and inlet ports for connection to user supplied 22mm ‘female’ connectors on
the breathing system. These must be rigid and robust (not plastic) and
separated by a minimum of 10 cm between centres to accommodate filter
HMEs.
4.
All elements in the gas pathway must meet biological safety and low-pressure
oxygen safety standards, especially to minimise risk of fire or contamination of the patient’s airway.
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