PCB Schematic Draft
Table
| Subsystem | Failure mode | Effect | Severity 1-10 | Likelihood 1-10 | Detection 1-10 | RPN | Mitigation / next action |
|---|---|---|---|---|---|---|---|
| Output stage | Excessive stimulation current | Pain, burn, nerve/tissue injury | 9 | 4 | 7 | 252 | Measure current into low/nominal/high dummy loads; define hardware current limiting. |
| Output waveform | Net DC through electrodes | Skin irritation, electrochemical injury | 8 | 4 | 7 | 224 | Measure DC offset and charge balance; require blocking/charge balancing if absent. |
| Boost rail | VSTIM overvoltage | Excessive electrode voltage or component stress | 8 | 4 | 6 | 192 | Identify U2, confirm feedback divider, measure open-load VSTIM. |
| Unknown U1/U2 | Misidentified pinout/topology | Incorrect schematic, unsafe assumptions | 8 | 6 | 6 | 288 | Use continuity mapping, IC identification research, and bench probing before layout/manufacture. |
| Battery | Coin-cell short or reverse insertion | Heating, leakage, failure | 6 | 3 | 5 | 90 | Add/verify protection and polarity features; inspect original mechanical design. |
| Brownout | Control IC malfunction at low battery | Unexpected stimulation or stuck output | 8 | 4 | 7 | 224 | Test depleted battery behavior; verify reset/disable paths. |
| Electrodes | Open/intermittent contact | High-voltage transients or unexpected pulses | 7 | 5 | 6 | 210 | Test open-load and intermittent-load conditions; add output clamps if needed. |
| Lab test setup | Mains-referenced instrument connected while worn | Shock hazard / isolation defeat | 10 | 3 | 5 | 150 | Never test on body while connected to bench instruments; use isolated/differential measurement. |
| Materials/contact | Skin-contact material not biocompatible | Irritation/allergy | 6 | 4 | 6 | 144 | Track electrode plating/material; evaluate ISO 10993 if productized. |
VSTIM and each electrode pad.Scope
Prominent Safety Warning
Failure Mode Table
Electrical Output Safety Limits to Measure
Test Precautions
Top Risk Priority Actions