Formal assessment requires more than broad statements such as “0–4 mA” or “low-frequency pulse.” The purpose of the parameter file is to let a reviewer understand and reproduce the actual output.
1. Current and voltage
For each level or program, state maximum, typical and tolerance values under open-circuit, standard-load and body-equivalent conditions. A constant-current system should disclose its voltage limit; a constant-voltage system should show current change across loads.
2. Waveform and timing
- DC or AC, monophasic or biphasic.
- Square, sine or custom waveform.
- Base and modulation frequency.
- Pulse width, interval and duty cycle.
- Rise/fall time and polarity switching.
- Program duration and cycle.
3. Electrodes and contact
Number, area, material, polarity, spacing, conductive medium and fixation affect current density. Rollers, probes, patches and hand-held return circuits should be described separately.
4. Software program mapping
Every App or screen program needs a traceable hardware output. Marketing labels such as soothing, lifting or revitalising cannot replace a parameter matrix. Software versions that change timing or output require version control.
5. Measurement method
Record instruments, loads, connection, sampling and calculation. Chip specifications or theoretical calculations do not replace measurement at the complete device output. Fault conditions such as open circuit, short circuit, electrode detachment and battery change may also need verification.
The complete parameter table is the common basis of instructions, technical requirements, tests and classification, and should be maintained by R&D.