Table 1

Engineering design inputs

Engineering requirementsUser need(s)Design input(s)
Physical embodimentSupport patient weight up to 800 lbsSupport 1200 lbs
EnvironmentalIR operating roomSterile and radiolucent
SterilitySterile operationAmerican Society for Testing and Materials (ASTM) Standard E1766
PerformanceDoes not fail during procedureNo failure after 6 hours use
SafetyDoes not fail during procedureNo failure after 6 hours use
Reliability and maintenanceLasts 2–3 procedures a week6 hours use six times a week
Packaging and labellingInfinite shelf lifeInfinite shelf life
Interfacing devicesInterventional Radiology (IR) tables (Siemens, Phillips and so on)
Modular overlay
IR tables
Modular overlay
Interfacing requirementMeets height and width of eachHeight and width of both
Human factorsEasy to useClear instruction
Regulatory considerationsFood and Drug Administration (FDA class IFDA class I
OtherPatient rotationRotate patient 90°