# PWR-216 — Biohybrid human–machine control: learner worksheet Release: Revision 7T · Full Tutorial Edition Estimated time: Estimated 29 min reading and worksheet pass Difficulty: Advanced Equipment: Specialist equipment — Declared Biohybrid human–machine control fixture: Compare four canonical records: neurally controlled reach, long-term BCI communication, neuromusculoskeletal prosthesis control and intraneural sensory feedback.; Setup aid for Map the full control loop: Keep the activity to document analysis; do not handle implants, stimulation equipment, biological material or live devices.; Biohybrid human–machine control log: User-chosen function, decoder and interface stability, adverse events, reversibility, repair burden, authorship and device-on/off outcomes; retain Biohybrid human–machine control errors, assistance, stop and fallback.; Biohybrid evidence map: trace biological signal, decoder, robotic action, confirmation and adverse events in “Reach and grasp by people with tetraplegia using a neurally controlled robotic arm”. Add uptime, independence conditions, support and failures from the long-term intracortical BCI study. Use the NIST Privacy Framework for neural and message records. Missing device-off function remains an explicit gap, not an invitation to experiment. Space: Specialist setting Automated structural checklist: 10 of 10 structural checks present Evidence quality/context: G5; Deep research depth Automated method-quality band: Comprehensive Method-rating basis: Structure coverage, instruction/check specificity, alternative distinctness, source troubleshooting, comparison depth and whether purpose/check fields are authored rather than derived. Editorial review: Pending manual editorial sign off ## Before you begin - [ ] I read the tutorial authority and stop conditions. - [ ] I have the required equipment/space or a declared accessible alternative. ## Canonical source context Build a cross-study map from neurally controlled reach and long-term BCI communication, tracing biological input, decoder, machine action, confirmation, adverse events and device-off outcome. Expose system dependence and missing transfer before writing an ethical clinical research gate. The activity teaches evidence analysis, never implantation, stimulation or device construction. Target outcome: The learner builds a cross-study evidence map, tests whether function depends on the complete implanted or wearable system, and writes the ethical and clinical gate for further research. ### Authority and setup conditions - Obtain full papers, corrections, supplements and current official FDA/ethics guidance. - Keep the activity to document analysis; do not handle implants, stimulation equipment, biological material or live devices. - Start check for Biohybrid human–machine control: “Human–machine fusion” is replaced by a testable system claim. - Top-of-sheet stop for Biohybrid human–machine control: Stop if adverse-event corrections, participant counts or device details cannot be reconciled. ### Required or supplied materials - Declared Biohybrid human–machine control fixture: Compare four canonical records: neurally controlled reach, long-term BCI communication, neuromusculoskeletal prosthesis control and intraneural sensory feedback. - Setup aid for Map the full control loop: Keep the activity to document analysis; do not handle implants, stimulation equipment, biological material or live devices. - Biohybrid human–machine control log: User-chosen function, decoder and interface stability, adverse events, reversibility, repair burden, authorship and device-on/off outcomes; retain Biohybrid human–machine control errors, assistance, stop and fallback. - Biohybrid evidence map: trace biological signal, decoder, robotic action, confirmation and adverse events in “Reach and grasp by people with tetraplegia using a neurally controlled robotic arm”. Add uptime, independence conditions, support and failures from the long-term intracortical BCI study. Use the NIST Privacy Framework for neural and message records. Missing device-off function remains an explicit gap, not an invitation to experiment. ## 1. Define the biohybrid claim Write the exact biological signal, decoder/interface, machine action, participant group, function and comparison. Why: “Human–machine fusion” is replaced by a testable system claim. Success check: “Human–machine fusion” is replaced by a testable system claim. Accessible alternative: Complete the same research action — “Write the exact biological signal, decoder/interface, machine action, participant group, function and comparison.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: ““Human–machine fusion” is replaced by a testable system claim.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 2. Map the full control loop Draw signal acquisition, preprocessing, decoding, actuator, sensory feedback, user correction and safe stop for each study. Why: Every result can be assigned to a component or loop. Success check: Every result can be assigned to a component or loop. Accessible alternative: Complete the same research action — “Draw signal acquisition, preprocessing, decoding, actuator, sensory feedback, user correction and safe stop for each study.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Every result can be assigned to a component or loop.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 3. Extract participant and selection Record number, condition, implantation, prior training, exclusions, withdrawals and care/support requirements. Why: Tiny selected samples remain visible. Success check: Tiny selected samples remain visible; verify it in the biohybrid evidence map. Accessible alternative: Complete the same research action — “Record number, condition, implantation, prior training, exclusions, withdrawals and care/support requirements.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Tiny selected samples remain visible; verify it in the biohybrid evidence map.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 4. Extract device-on function Record task success, speed, error, assistance, calibration, maintenance and home uptime using the study’s exact task. Why: Laboratory and home outcomes are not blended. Success check: Laboratory and home outcomes are not blended. Accessible alternative: Complete the same research action — “Record task success, speed, error, assistance, calibration, maintenance and home uptime using the study’s exact task.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Laboratory and home outcomes are not blended.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 5. Extract harm and repair burden Record surgery, infection, sepsis, explant, revision, skin/interface events, cybersecurity, caregiver setup and downtime. Why: Benefit is not reported without adverse and maintenance burden. Success check: Benefit is not reported without adverse and maintenance burden. Accessible alternative: Complete the same research action — “Record surgery, infection, sepsis, explant, revision, skin/interface events, cybersecurity, caregiver setup and downtime.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Benefit is not reported without adverse and maintenance burden.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 6. Check authorship and agency Ask how the person confirms commands or messages, rejects errors, overrides the system and controls data or device cessation. Why: Decoder output is not automatically equated with intention. Success check: Decoder output is not automatically equated with intention. Accessible alternative: Complete the same research action — “Ask how the person confirms commands or messages, rejects errors, overrides the system and controls data or device cessation.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Decoder output is not automatically equated with intention.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 7. Look for device-off transfer Extract any function after device removal or feedback loss and write “not shown” when absent. Why: Device-on performance is not called biological enhancement. Success check: Device-on performance is not called biological enhancement. Accessible alternative: Complete the same research action — “Extract any function after device removal or feedback loss and write “not shown” when absent.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “Device-on performance is not called biological enhancement.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## 8. Write the next ethical gate Require independent replication, clinical equipoise, consent/withdrawal, long-term surveillance, repair/explant plan, privacy/security and participant-chosen function. Why: The result is a research governance decision, never an implantation or build guide. Success check: The result is a research governance decision, never an implantation or build guide. Accessible alternative: Complete the same research action — “Require independent replication, clinical equipoise, consent/withdrawal, long-term surveillance, repair/explant plan, privacy/security and participant-chosen function.” — using speech-to-text, text-to-speech, enlarged text, keyboard-only navigation, shorter work blocks or a support person. Preserve this declared check: “The result is a research governance decision, never an implantation or build guide.” Do not convert the research task into capability practice. Alternative relationship: Target preserving when declared check is preserved Learner notes: ________________________________________________________________________________ Completed: [ ] ## Reflection What changed? ________________________________________________________________________________ What remains difficult? ________________________________________________________________________________ What will I repeat, adapt, ask for help with, or stop? ________________________________________________________________________________ --- Completion of this worksheet demonstrates tutorial participation only. It does not establish capability, qualification, safety clearance, diagnosis, treatment or independent validation.