Hardware Requirements Specification
Purpose
This document describe what RespiraWorks Ventilator hardware must do.
This document is meant to be read and agreed-upon by the project owners and by software developers during design and construction.
Todo
Specify the functional requirements, performance requirements, interface requirements, safety requirements, hazard mitigations
Requirements
Assembly
All subcomponents shall pass accelerated life testing equivalent to at least 336 hours (2 weeks continuous runtime)
The construction, assembly, and maintenance of the device shall be compatible with metric tooling/set ups.
The device must last 2000 hours if the maintenance schedule is followed.
The ventilator shall be operable by a user wearing standard PPE (e.g. latex or nitrile gloves)
The patient circuit shall interface with the vent thru 22mm ID tubing.The patient circuit shall interface with nasal cannulas or pillows through a standard 15mm ET tube adapter interface.
The assembly shall feature HEPA filters on the blower intake and exhaust pathways
- Fulfills
Enclosure openings shall not exceed 12.5mm diameter and shall feature no openings on the top face .
- Fulfills
Ventilation openings on the enclosure shall not be adjacent to electronics or other sensitive components targeted by IEC 61000-4-1 series of test.
- Fulfills
All hardware components shall operate without adverse effect at altitudes up to 10000 ft.
- Fulfills
Enclosure does not degrade when cleaned with X% bleach solution
- Fulfills
Gas inlet ports are clearly labeled per X
Pneumatics
The blower shall provide a flow rate of at least 60 L/min.(Stretch goal) the blower shall provide a flow rate of at least 130 L/min.
The overpressure relief device shall be set to automatically relieve pressure at or above 60 cm H2O.
- Fulfills
The device must not let the patient asphyxiate if they are attempting to breathe, even if the device fails. This can be achieved by preventing pressure from dropping below -4 cm H20 and limiting the resistance to 3 cmH20/l/s
The pneumatic circuit shall reach maximum flow rate (e.g. 60 L/min) in 100 ms.
The device must be able to detect that a patient is trying to trigger an inhale or exhale. This requires being able to measure changes in flow rate to a resolution of 5 L/min during inspiratory and expiratory holds.
The oxygen input port shall be DISS compatible up to 440 kPa
Electronics
- Fulfills
The device shall provide a battery monitor for assessing battery presence, charge, and failure.
The device shall provide a sensor indicating whether power is coming from AC or battery and whether AC is available
The display shall support touch input, 8-bit color and a minimum refresh rate of 30 fps.
The electronic non-volatile memory shall be rated for at least 10e6 read/write cycles.
- Fulfills
The device battery shall have a charge capacity of X Ah at 12 volts nominal.
The electronics shall include a real-time clock with independent battery (e.g. coin cell) supply.
The electronics shall include non-volatile memory of at least 1GB
Sensors and Actuators
The pressure sensor shall have a resolution of 1 cmH2O and a range of 0 - 60 cmH2O
The inhale and exhale flow sensors shall have a resolution of X L/min and a range of Y L/min.
The O2 sensor shall measure oxygen fraction from 21% to 100% with an accuracy of 5%.
- Fulfills
The temperature sensors shall have range -40 to +125 C with a minimum resolution of 1 C
Traceability Matrix
System Requirements to Hardware Requirements
Hardware Requirements |
System Requirements |
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