Engineering requirements | User need(s) | Design input(s) |
Physical embodiment | Support patient weight up to 800 lbs | Support 1200 lbs |
Chemical/biological | N/A | N/A |
Environmental | IR operating room | Sterile and radiolucent |
Sterility | Sterile operation | American Society for Testing and Materials (ASTM) Standard E1766 |
Performance | Does not fail during procedure | No failure after 6 hours use |
Safety | Does not fail during procedure | No failure after 6 hours use |
Reliability and maintenance | Lasts 2–3 procedures a week | 6 hours use six times a week |
Packaging and labelling | Infinite shelf life | Infinite shelf life |
Interfacing devices | Interventional Radiology (IR) tables (Siemens, Phillips and so on) Modular overlay | IR tables Modular overlay |
Interfacing requirement | Meets height and width of each | Height and width of both |
Human factors | Easy to use | Clear instruction |
Regulatory considerations | Food and Drug Administration (FDA class I | FDA class I |
Other | Patient rotation | Rotate patient 90° |