======RoboELF - JHU Internal Use Only Material====== =====Material for FDA Submission===== ^ Document Link ^ Last Edit ^ Responsible Person ^ Ready for Submission ^ | {{:research:robo-elf_electrical_schematic_updated.gif?200| Electrical Schematic}} | 4-8-13 | Kevin | Yes | | {{:research:robo-elf_poster.pptx| Robo-ELF Clinical Poster}} | 4-8-13 | Kevin | Yes | | {{:research:robo-elf_paper.pdf| Laryngoscope Paper}} | 4-8-13 | Kevin | Yes | | {{:research:user_manual_updated.docx|User Manual}}, {{:research:roboelf_jhu_only:roboelf_user_manual.pdf| pdf}} | 3-18-13 | Kevin | Yes | | Software Overview: {{:research:roboelf_jhu_only:robo-elf_software.pptx|ppt}}, {{:research:roboelf_jhu_only:robo-elf_software.pdf|pdf}} | 12-4-12 | Jon | Yes | | {{:research:roboelf_jhu_only:roboelf_software.docx|Software Documentation}}, {{:research:roboelf_jhu_only:roboelf_software_description.pdf| pdf}} | 3-14-13 | Jon | Yes | | {{:research:roboelf_jhu_only:fmea_and_test_plan.xlsx|FMEA and Test Plan}}, {{:research:roboelf_jhu_only:roboelf_fmea.pdf| FMEA}}, {{:research:roboelf_jhu_only:roboelf_test_plan.pdf| Test Plan}} | 3-25-13 | Jon | Yes | | {{:research:i110959_fda_concerns.pdf|FDA Response to previous submission}} | 10-25-11 | Kevin | Yes | | {{:research:response_to_concers_-_updated_3-18-13.docx| Response to Concerns}}, {{:research:roboelf_jhu_only:roboelf_response_to_fda_concerns_2013.pdf| pdf}} | 3-18-13 | Kevin/Dr. Richmon | Yes | | {{:research:maintainence_manual.docx|Maintenance Manual}}, {{:research:roboelf_jhu_only:roboelf_maintainence_manual.pdf| pdf}} | 2-27-13 | Kevin | Yes | | {{:research:maintenance_check_list.docx|Maintenance Check List}}, {{:research:roboelf_jhu_only:roboelf_maintenance_check_list.pdf| pdf}} | 2-27-13 | Kevin | Yes | | {{:research:technical_summary.docx|Technical Description}}, {{:research:roboelf_jhu_only:roboelf_technical_summary.pdf| pdf}} | 3-18-13 | Kevin | Yes | | Clinical Updates | - | Dr. Richmon | Yes | | {{:research:robo-elf_eforma_3-18_updated.doc|IRB Protocol }}, {{:research:roboelf_jhu_only:roboelf_irbprotocol.pdf| pdf}} | 3-25-13 | Dr. Richmon | Yes | =====Design Documents===== {{:research:roboelf_jhu_only:joystick_wiring.docx|RoboELF Joystick Wiring}} {{:research:roboelf_jhu_only:new_wiring_diagram.xlsx|RoboELF Wiring}} {{:research:roboelf_jhu_only:roboelf_known_issues.docx|Known Issues/Bugs}} =====Meeting Documents===== Review Meeting Sign-in Sheets: