Hazard Analysis

Hazard	Hazardous Situation	Potential Harms	Severity	Occurrence	Risk
Battery Depletion	No power or data	Ineffective treatment	2	2	R1
Material Degradation	Medication not delivered properly	Reduced treatment effectiveness	4	4	R3
Biofilm Build up	Feedback malfunction	Incorrect data	3	3	R2
Overheating of Electronics	Discomfort due to heat	Discomfort or potential burns	2	2	R1
Improper Device Assembly	Device malfunction	Reduced treatment efficiency	4	4	R3
Sensor malfunction	Inaccurate feedback	User to be mislead	3	4	R2
Delayed Timing Activation	Delay of treatment	Reduced treatment effectiveness	5	3	R3
Microcontroller Malfunction	No data or improper feedback	User decision inaccuracy	3	3	R2

Note:

R1: Low level of risk

R2: Moderate level of risk

R3: High level of risk

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Rating	Probability of Occurrence	Description
5	Frequent	Events are likely to occur during use.
4	Occasional	Events may occur during typical use.
3	Remote	Event is unlikely but still possible to occur during typical use.
2	Rare	Event is very unlikely to occur however it is still possible.
1	Very Unlikely	Events are extremely unlikely to occur during typical use, almost impossible.

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Ratings	Severity of Effect	Consequence	Treatment
5	Death	–	–
4	Severe Discomfort	Struggles to breathe, speaks in single words; severe wheezing	Hospital Visit
3	Moderate Discomfort	Noticeable shortness of breath, audible wheezing, and visible retractions	Hospital Visit for abundant treatment
2	Mild Discomfort	Mild Shortness of breath while walking	Self-Treatment
1	No Harm	–	–

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Mitigations (for R3)

Material Degradation due to Cleaning 

• Use a corrosion resistant materials
  • Select materials made to withstand repeated cleaning cycle 
  • Degradation resistant materials 
• User guidelines for cleaning
  • Design a safe and sustainable cleaning solution 
  • List acceptable cleaning materials that can be used to avoid degradation 

Resisdual Risk Evaluation 

• Simulating typical cleaning cycles on device materials
  • Observe degradation of material 
  • Ensure risk remains below acceptable level 

Improper Device Assembly / Disassembly 

• Clear assembly instructions
  • Provide step-by-step instructions associated with illustrations to guide users through the assembly/disassembly process 
• Design with intuitive assembly
  • Implement design principles that ensure the device is assembled correctly

Residual Risk Evaluation 

• Conduct a usability test
  • Confirm risk of misassembly is at an acceptable level
  • Acquire feedback to ensure assembly process is straightforward and intuitive 

Delayed Timing of Activation 

• Reliable timing mechanism
  • Ensure microcontroller is calibrated and rigorously tested to reduce delay 
  • Program device to reset before the device is activated 

Residual Risk Evaluation 

• Test timing accuracy
  • Confirm delay is minimized 
  • Risk remains below acceptable