Design Specification |
Description and Metric |
Size and Ease of Use of Imaging Device |
The device should be easily gripped by a person with a 12 cm hand length ("12 cm grip") or larger. The device should be easily operated with 1 hand. |
Image Brightness |
The wound image should be taken in standard natural or indoor lighting; it should not be dark or obscured by excess shadow. |
Image Resolution |
The image used for the wound analysis should have a 1 megapixel resolution or greater in order to be compatible with the software. |
Measurement Accuracy of Image-to-Model Conversion |
The maximum measurement error for conversion of the wound image to the wound surface model is 10%. |
Wound Size |
The wound sizes that can be addressed are 1~15cm in length, 1~15cm in width, and 0~5cm in depth. |
Wound Severity |
The system is applicable to stage 2~3 ulcers. |
Processing Time |
The processing time required to develop the digital wound template from the digital image is within 10~30 minutes. |
Complexity of Software |
The software should be simple enough to be used after 30 minutes or fewer of training. (This time does not include HIPAA regulations, sterility, or other hospital-specific protocol training). |
Skill Level of Software User |
No special technical skills are required except English language proficiency and basic understanding of computer use. All healthcare professionals including physicians, nurses, and technicians should be able to use the program after the training. |
Power Source |
The device and system should be compatible with typical wall power: 120V, 60Hz. |
Template Options |
A simpler and a more complex template are generated by the software for each wound image that is processed. |
Production Time |
The production time required to make the customized bandage from the digital template is within 0.5~3 hours. |
Sterility |
The process of producing the custom bandage template must meet current U.S. medical standards of sterility. |