TestReport: Oxygen combustion safety

CohenLabPrinceton / pvp

Raspberry pi code for controlling the rapid-deploy critical care ventilator

GNU General Public License v3.0

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TestReport: Oxygen combustion safety #93

Closed ProfDJCohen closed 4 years ago

ProfDJCohen commented 4 years ago

Ref: CR501 Clause 11 / IEC 60601-1 (11.2.2.1 is MISSING)

RISK of fire in an OXYGEN RICH ENVIRONMENT

If the medical device is intended to be used with oxygen:

[ ] Describe means of protection to reduce the risk of ignition

If the medical device is intended to be used with oxygen operating at medical gas pipeline pressures:

[x] Describe means of protection to taken to ensure that auto-ignition from adiabatic compression cannot occur

ProfDJCohen commented 4 years ago

AAMI CR502 implies that auto-ignition is only a risk at 5 bar or higher. 50 psig is 3.5 bar, so I think we're OK there. However, we need careful discussion of combustion risk mitigation.

juliennelachance commented 4 years ago

Ignition risk mitigation includes: no contactors (like relays: everything we're using is solid-state) so as to avoid arcs; enclosure of the electronics; material selection in the oxygen pathway; etc.

CohenLabPrinceton commented 4 years ago

@juliennelachance thanks, but we need to be exhaustive, so please do not say ‘etc’. If there is something else that helps, write it explicitly. A concise, bulleted list is best. I am hoping to be able to paste these answers directly into the EUA so they should be formal (and as concise as possible at the same time). When done, please update the 'checkbox' above for the section you addressed.

Please also further clarify:

[ ] Enclosure of the electronics--how are they enclosed (I haven't seen an enclosure yet so I don't know what to think), and how does this protect from oxygen released from the expiratory port?
[ ] Materials selection--how were materials selected to reduce oxygen fire risks?

CohenLabPrinceton commented 4 years ago

@zajdel speaker could be an issue.