1) Severity table used for risk assessment – with score definitions
Severity Table
Rating | Severity of Effect | Future consequences | Treatment |
10 | Death | – | – |
9 | Cardiac Arrest | Cardiac Tissue Damage | Use a Defibrillator |
8 | Arthymea | Unstable Heart Rate | Reset heart rhythm |
7 | Pulmonary Embolism | Lung cell death | Lung surgery |
6 | Severe Skin Burns | Permanent tissue damage, scarring | Burn treatment, and surgeries |
5 | DVT Formation | Vessel Damage | Anticoagulant medication |
4 | Mild Skin Burns | Tissue Damage, Scarring | Burn treatment, |
3 | Skin Burns from electric shocks | Tissue damage | Heals over time. |
2 | Severe Skin Irritation | Long Lasting Discomfort | Remove Irritant, Cortical Lotion |
1 | Mild Skin Irritation | Mild Discomfort | Remove Irritant |
2) Occurrence table used for risk assessment – with score definitions
Rating | Probability of Occurrence |
10 | Happening every use |
9 | Happening every other user |
8 | 1 in 5 |
7 | 1 in 10 |
6 | 1 in 50 |
5 | 1 in 100 |
4 | 1 in 500 |
3 | 1 in 1000 |
2 | 1 in 5000 |
1 | Inconceivable |
3) RPN table used for risk classification

4) Hazard and risk assessment spreadsheet – with score justifications
Hazard | Chain of Events | Hazardous situation | Potential Harms | Severity | Probability | Risk |
Battery Explosion | Overtaxed power supply, Overheated Battery, failure of battery controller. Batteries get wet | Battery incineration | Skin burns | Serious (6) | Improbable(1) | R2 |
Electric shock | Circuit malfunction, Circuits get wet, Physical damage to device creates open circuit. | Electric shock | Skin burns | Minor(3) | Improbable(1) | R1 |
Skin irritation | LED lights react to skin, camera reacts to skin, rough material to the skin | Reaction between the skin and some parts of the device | Reddening and inflammation, which Skew the results | Negligible (1) | Occasional (6) | R2 |
Wrong data collection – O2 levels | Device disconnects from Oximiter. | Low O2 stats present without detection | DVT Formation, Pulmonary Embolism, Vessel Damage | Critical (7) | Improbable(1) | R2 |
Wrong data collection – inflammation levels | Device Dysfunction inflammation | Inflammation without detection | DVT Formation, Pulmonary Embolism, Vessel Damage | Critical(7) | Improbable (1) | R2 |
LED Burns | Arduino malfunctions increase the time of LED light exposure | High temperature | Damages skin | Negligible (1) | Improbable (1) | R1 |
Cut blood circulation | Device is too tight, device is too small for the user to use | Reduction in blood circulating to lower extremities | Increase vessel damage and clotting | Critical (7) | Remote(3) | R2 |
5) Mitigation, as needed
Hazard | Mitigation technique |
Battery Explosion | Microcontroller that checks voltage overshoot and shuts off power. |
Electric shock | Ground the device, Protect the device circuits from water |
Skin irritation | Instruct medical practitioners to check with patients for any discomfort regularly. |
LED Burns | The frequency of what we measure will depend on the time the LED takes to cool down to room temperature. |
Cut blood circulation | Instruct medical practitioners on proper technique to tighten and secure device fittings. |