The dose the pilot study delivers has to come from your own bench measurement of your own unit. Published figures for this kind of therapy differ by up to a thousandfold, so they cannot stand in. Fill this in, print it, and attach it to the protocol.
One row per preset program on the unit, measured at the stated test load.
| Program | Measured rate (Hz) | Pulse width (µs) | Peak V @ level 10 | Peak mA @ level 10 | Peak mA @ level 20 | Charge/pulse (µC) @ 20 | Charge density (µC/cm²) @ 20 | Average power (mW) @ 20 |
|---|---|---|---|---|---|---|---|---|
| 1. KneadingTENS | ||||||||
| 2. SqueezingTENS | ||||||||
| 3. TappingTENS | ||||||||
| 4. AcupunctureTENS | ||||||||
| 5. ScrapingTENS | ||||||||
| 6. CuppingTENS | ||||||||
| 7. ShapingEMS | ||||||||
| 8. ToningEMS | ||||||||
| 9. EnduranceEMS | ||||||||
| 10. Warm-upEMS | ||||||||
| 11. RecoveryEMS | ||||||||
| 12. RelaxEMS |
AMENDMENT A — BENCH DOSIMETRY RECORD TayaPulse postoperative pilot study, protocol version 1.0 Prepared 2026-09-18 Sponsor: [sponsor legal name] ------------------------------------------------------------------------ A1. PURPOSE ------------------------------------------------------------------------ This amendment records the measured electrical output of the study applicator. Published values for this class of therapy differ by up to three orders of magnitude and are therefore not used. The values below, and only these values, define the dose delivered in the protocol. ------------------------------------------------------------------------ A2. DEVICE UNDER TEST ------------------------------------------------------------------------ Pod model name: [model name as marked on the unit] Other markings on the unit: [model code, batch, regulatory marks] Serial numbers tested: [serial numbers of the units on the bench] Firmware version: [firmware version reported by the unit] Electrode contact area (cm² per pad): [measured pad area] Test load (ohms): [resistive load used, e.g. 500 Ω] Measuring instrument: [oscilloscope / current probe make and model] Instrument calibration date: [calibration date and certificate number] Test facility: [laboratory name and address] Test engineer: [name and role of the person who took the readings] Test date: [date of measurement] Ambient conditions: [temperature and relative humidity] Radiated RF emission check: [result of the emission scan confirming no 13.56/27.12 MHz carrier is produced] ------------------------------------------------------------------------ A3. MEASURED OUTPUT BY PROGRAM ------------------------------------------------------------------------ Program 1 — Kneading (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 2 — Squeezing (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 3 — Tapping (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 4 — Acupuncture (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 5 — Scraping (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 6 — Cupping (TENS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 7 — Shaping (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 8 — Toning (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 9 — Endurance (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 10 — Warm-up (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 11 — Recovery (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] Program 12 — Relax (EMS) Measured rate (Hz): [not measured] Pulse width (µs): [not measured] Peak V @ level 10: [not measured] Peak mA @ level 10: [not measured] Peak mA @ level 20: [not measured] Charge/pulse (µC) @ 20: [not measured] Charge density (µC/cm²) @ 20: [not measured] Average power (mW) @ 20: [not measured] ------------------------------------------------------------------------ A4. WORST-CASE LIMITS AND SAFETY VERIFICATION ------------------------------------------------------------------------ Highest charge density measured (µC/cm² per phase): [worst-case value across all programs at level 20] Highest RMS current density (mA/cm²): [worst-case value across all programs at level 20] Implant lockout verified: [how the hardware lockout was tested and the result] Intensity and time clamp verified: [result of commanding a value above the ceiling and confirming the unit clamped it] ------------------------------------------------------------------------ A5. STATEMENT ON RADIOFREQUENCY OUTPUT ------------------------------------------------------------------------ The pod is an electrical stimulator. It delivers a low-frequency pulse through adhesive electrodes and produces no 13.56 MHz or 27.12 MHz carrier, so no radiofrequency dose is attributed to a pod session anywhere in the study record. Emission scan result: [result of the emission scan] ------------------------------------------------------------------------ A6. CONCLUSION ------------------------------------------------------------------------ [engineer's conclusion on whether the measured output is within the limits set in the protocol] Signed: [test engineer] Date: [date] Countersigned (sponsor): ______________________ Date: ______________