Table 7 DesignSafe: This table displays the safety analysis output from DesginSafe (both initial assessment and after the risk reduction methods). The guide sentence is used to interpret the table.

User	Task	Hazard / Failure Mode	Initial Assessment		Risk Reduction Methods	Final Assessment		Responsible
			Severity/Exposure/Probability	Risk Level		Severity/Exposure/Probability	Risk Level
Physical Therapist	Therapy Administration	electrical / electronic : normally live parts(direct contact) stimulating electrodes	Minimal Occasional Possible	Moderate	ensure the electrodes or battery are disconnected	Minimal Frequent Negligible	Low	Physical Therapist
Physical Therapist	Therapy Administration	ergonomics / human factors : unfamiliarity with hazards and risks novel nature of the system	Minimal Remote Probable	Moderate	have a training session	Minimal Remote Unlikely	Low	Company Literature
Physical Therapist	Therapy Administration	ergonomics / human factors : adjacent piecesof the AFO slide and piston and can pinch fingers	Minimal Remote Probable	Moderate	have a training session	Minimal Remote Unlikely	Low	Company Literature
Orthotist	Initial Fitting	material handling : Cutting and trimming the thermoplastic and stripping wires	Slight Frequent Unlikely	Moderate	take care and wear gloves	Minimal Frequent Unlikely	Moderate	Orthotist
Orthotist	Adjustments	heat / temperature : severe heat heat gun	Slight Occasional Possible	Moderate	wear heat gloves or clamp the AFO in place	Minimal Frequent Unlikely	Moderate	Orthotist
Orthotist	Adjustments	material handling : Impact attaching rivets with hammers	Minimal Frequent Possible	Moderate	wear gloves or use a clamp	Minimal Frequent Unlikely	Moderate	Orthotist
Technician	AFO/FES system production	ergonomics / human factors : posture bending while using machines for extended periods	Minimal Frequent Possible	Moderate	limit work sessions or reposition machinery	Minimal Frequent Negligible	Low	Technician and facility manager
Technician	AFO/FES system production	ventilation : not enough ventilation from lead fumes during soldering	Serious Frequent Possible	Moderate	introduce ventilation or wear masks	Serious Frequent Negligible	Moderate	Technician and facility manager
Technician	AFO/FES system production	fire and explosives : dust from plaster of paris mix	Minimal Occasional Unlikely	Low	wear masks	Minimal Occasional Negligible	Low	In-process Technician
Technician	AFO/FES system production	noise / vibration : levels > 90 dba from sander and other equipment in confined spaces	Minimal Frequent Unlikely	Moderate	wear ear-plugs and move machinery apart	Minimal Frequent Negligible	Low	In-process Technician and facility manager
Technician	AFO/FES system production	heat / temperature : severe heat oven	Minimal Frequent Unlikely	Moderate	wear gloves	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	heat / temperature : soldering iron	Minimal Frequent Unlikely	Moderate	train and wear gloves	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	pressure : vacuum using suction to form-fit the high temperature thermoplastic	Minimal Frequent Unlikely	Moderate	keep away from the open end of the tube	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	material handling : Cutting trimming the AFO and making straps, pads, and wires	Slight Frequent Unlikely	Moderate	wear gloves and take precausion	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	material handling : Impact attaching rivets with hammers	Minimal Frequent Possible	Moderate	wear gloves or use a clamp	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	change in material properties : viscosity plastic and plaster changes viscocity rapidly	Minimal Frequent Negligible	Low	experience and taking caution	Minimal Frequent Negligible	Low	Technician
Technician	AFO/FES system production	slips / trips / falls : slips water spills on the floor	Slight Frequent Unlikely	Moderate	rubber shoes, drained floors, mops, and signage	Minimal Frequent Negligible	Low	In-process Facility Manager
Patient	Therapy	electrical / electronic : normally live parts(direct contact) electrodes	Minimal Frequent Unlikely	Moderate	ensure the electrodes or batteries are disconnected	Minimal Frequent Negligible	Low	Caregiver
Patient	Therapy	ergonomics / human factors: pressure points and bruises from improperly-formed AFO	Minimal Frequent Possible	Moderate	have orthotist, physical therapist, and caregiver check AFO multiple times	Minimal Frequent Negligible	Low	Orthotist, physical therapist, and caregiver
Patient	Therapy	ergonomics / human factors : posture improper therapy can adversely affect gait and posture	Serious Frequent Negligible	Moderate	have physical therapist regularly check patient	Serious Occasional Negligible	Moderate	Caregiver and Physical Therapist
Patient	Therapy	ergonomics / human factors : excessive exertion dorsiflex muscles can become fatigued	Minimal Frequent Possible	Moderate	limit training session, rest frequently	Minimal Frequent Unlikely	Moderate	Caregiver
Patient	Therapy	ergonomics / human factors : repetition training for 30 minutes	Minimal Frequent Possible	Moderate	limit training session, rest frequently	Minimal Frequent Unlikely	Moderate	Caregiver
Patient	Therapy	ergonomics / human factors : physiological effects having high-expectations and comparing to other patients	Slight Frequent Negligible	Moderate	encourage the patient, explain condition and system	Slight Occasional Negligible	Low	In-process Caregiver, Physical Therapist, Teachers, etc
Patient	Therapy	slips / trips / falls : tripping	Slight Frequent Possible	High	have caregiver/physical therapist near by	Slight Frequent Unlikely	Moderate	Complete [12/1/2007] Caregiver
Caregiver	Therapy Administration	ergonomics / human factors : unfamiliarity with hazards and risks novel nature of the system	Minimal Remote Probable	Moderate	administer training course	Minimal Remote Possible	Low	Company Literature
Caregiver	Therapy Administration	ergonomics / human factors : lack of natural ability / skill not trained as a physical therapist	Minimal Frequent Probable	High	train caregiver thoroughly and include literature	Minimal Occasional Possible	Moderate	Caregiver and Physical Therapist
Caregiver	Installation of system on patient	electrical / electronic : normally live parts(direct contact) electrodes	Minimal Frequent Unlikely	Moderate	discommect electrodes and batteries while touching	Minimal Frequent Negligible	Low	Caregiver
Guide sentence: When doing [task], the [user] could be injured by the [hazard] due to the [failure mode].