.. hardware_requirements: Hardware Requirements Specification =================================== Purpose ------- This document describe *what* |PROJECT_NAME| 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 ^^^^^^^^ .. item:: RW-HW-6 :fulfills: RW-SYS-16 All subcomponents shall pass accelerated life testing equivalent to at least 336 hours (2 weeks continuous runtime) .. item:: RW-HW-8 :fulfills: The construction, assembly, and maintenance of the device shall be compatible with metric tooling/set ups. .. item:: RW-HW-10 :fulfills: RW-SYS-16 The device must last 2000 hours if the maintenance schedule is followed. .. item:: RW-HW-23 :fulfills: The ventilator shall be operable by a user wearing standard PPE (e.g. latex or nitrile gloves) .. item:: RW-HW-30 :fulfills: RW-SYS-63 RW-SYS-77 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. .. item:: RW-HW-33 :fulfills: RW-SYS-12 The assembly shall feature HEPA filters on the blower intake and exhaust pathways .. item:: RW-HW-43 :fulfills: RW-SYS-124 Enclosure openings shall not exceed 12.5mm diameter and shall feature no openings on the top face . .. item:: RW-HW-44 :fulfills: RW-SYS-124 Ventilation openings on the enclosure shall not be adjacent to electronics or other sensitive components targeted by IEC 61000-4-1 series of test. .. item:: RW-HW-45 :fulfills: RW-SYS-137 All hardware components shall operate without adverse effect at altitudes up to 10000 ft. .. item:: RW-HW-46 :fulfills: RW-SYS-140 Enclosure does not degrade when cleaned with X% bleach solution .. item:: RW-HW-47 :fulfills: RW-SYS-136 Gas inlet ports are clearly labeled per X Pneumatics ^^^^^^^^^^ .. item:: RW-HW-3 :fulfills: RW-SYS-92 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. .. item:: RW-HW-11 :fulfills: RW-SYS-10 The overpressure relief device shall be set to automatically relieve pressure at or above 60 cm H2O. .. item:: RW-HW-12 :fulfills: RW-SYS-144 RW-SYS-92 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 .. item:: RW-HW-15 :fulfills: RW-SYS-42 The pneumatic circuit shall reach maximum flow rate (e.g. 60 L/min) in 100 ms. .. item:: RW-HW-16 :fulfills: RW-SYS-89 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. .. item:: RW-HW-35 :fulfills: RW-SYS-76 RW-SYS-24 The oxygen input port shall be DISS compatible up to 440 kPa Electronics ^^^^^^^^^^^ .. item:: RW-HW-27 :fulfills: RW-SYS-121 RW-SYS-119 RW-SYS-120 The device shall provide a battery monitor for assessing battery presence, charge, and failure. .. item:: RW-HW-28 :fulfills: RW-SYS-121 RW-SYS-120 RW-SYS-119 RW-SYS-117 RW-SYS-118 The device shall provide a sensor indicating whether power is coming from AC or battery and whether AC is available .. item:: RW-HW-32 :fulfills: RW-SYS-103 RW-SYS-102 RW-SYS-101 RW-SYS-32 RW-SYS-5 RW-SYS-3 The display shall support touch input, 8-bit color and a minimum refresh rate of 30 fps. .. item:: RW-HW-34 :fulfills: RW-SYS-16 The electronic non-volatile memory shall be rated for at least 10e6 read/write cycles. .. item:: RW-HW-36 :fulfills: RW-SYS-74 RW-SYS-117 RW-SYS-50 The device battery shall have a charge capacity of X Ah at 12 volts nominal. .. item:: RW-HW-38 :fulfills: RW-SYS-69 The electronics shall include a real-time clock with independent battery (e.g. coin cell) supply. .. item:: RW-HW-39 :fulfills: RW-SYS-69 The electronics shall include non-volatile memory of at least 1GB Sensors and Actuators ^^^^^^^^^^^^^^^^^^^^^ .. item:: RW-HW-2 :fulfills: RW-SYS-111 RW-SYS-110 RW-SYS-115 RW-SYS-3 RW-SYS-5 The pressure sensor shall have a resolution of 1 cmH2O and a range of 0 - 60 cmH2O .. item:: RW-HW-4 :fulfills: RW-SYS-113 RW-SYS-112 RW-SYS-116 RW-SYS-115 RW-SYS-89 RW-SYS-32 The inhale and exhale flow sensors shall have a resolution of X L/min and a range of Y L/min. .. item:: RW-HW-21 :fulfills: RW-SYS-72 The O2 sensor shall measure oxygen fraction from 21% to 100% with an accuracy of 5%. .. item:: RW-HW-41 :fulfills: RW-SYS-122 The temperature sensors shall have range -40 to +125 C with a minimum resolution of 1 C Traceability Matrix =================== .. item-matrix:: System Requirements to Hardware Requirements :target: RW-SYS- :source: RW-HW- :sourcetitle: Hardware Requirements :targettitle: System Requirements :type: fulfills