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Device Lab 67

TENS

TENS in the BMEssentia 3D Device Lab

A step-up converter holds a compliance rail and a regulated sink pulls a set current through whatever the contact turns out to be. Charge per phase is the amplitude times the pulse width, exactly, so both controls are charge controls and the delivered dose is the same on any skin. What changes with the contact is the VOLTAGE the stage has to produce, and the current density, and neither of those is measured.

Also called: Tens Unit, Transcutaneous Electrical Nerve Stimulation. Arabic: التحفيز الكهربائي العصبي عبر الجلد. Device Lab 67 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Constant-current output stage, biphasic symmetric, two channels

A step-up converter holds a compliance rail and a regulated sink pulls a set current through whatever the contact turns out to be. Charge per phase is the amplitude times the pulse width, exactly, so both controls are charge controls and the delivered dose is the same on any skin. What changes with the contact is the VOLTAGE the stage has to produce, and the current density, and neither of those is measured.

Constant-voltage output stage, biphasic symmetric, two channels

A regulated voltage is applied across the pair and the contact decides the current. The skin is capacitive, so the current is a spike that decays inside the first fraction of the pulse: the charge that gets through is very nearly the contact capacitance times the voltage, and the capacitance is proportional to the contact area.

How it works: the main parts

What each part does, from the TENS lessons in the 3D Device Lab.

Nine-volt primary cell and compartment
5 millimetres, with two studs of deliberately different diameters on one end. The asymmetry is the whole of how it cannot be fitted backwards: there is no electronics anywhere in the handset doing that job, it is done by two pieces of brass being different sizes.
Step-up converter and compliance rail
A twelve-millimetre transformer with six visible windings, a switching device beside it and a small reservoir capacitor, occupying one end of the board. It turns nine volts into a rail of sixty, and that rail is not a specification about the output, it is a specification about how bad the contact is allowed to get.
Timing core and pulse generator
A seven-millimetre package with a crystal beside it, and it is the part that makes the waveform a waveform. It decides when each phase starts, how long it lasts, and how exactly the second phase mirrors the first.
Amplitude control
One key on the fascia, marked up and down, stepping in milliamps from zero to eighty. It is the only control on this device that anybody moves during use, and it is the only actuator on the only feedback loop the whole system has.
Pulse width control
A key marked in microseconds, from fifty to three hundred. On one of these two configurations it is the second charge control and on the other it does very nearly nothing, and the fascia is identical on both.
Pulse rate control
A key marked in hertz, from two to a hundred and fifty. Of the three settings on this device it is the one with the least effect on any single pulse and the most effect on what an hour adds up to, which makes it the one most often misread.
Series direct-current blocking capacitor
Two ten-microfarad capacitors on the board, one in series with each channel’s output. They are the only parts in the handset whose entire job is to make a number zero, and the number is the charge the waveform failed to cancel.
Inter-channel isolation gap
Three millimetres of bare board between two copper regions, with nothing in it. It is the only component on this device that is defined by the absence of anything, and the absence is what it is for.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Device Operates Differently Than Expected33
Inappropriate/Inadequate Shock/Stimulation14
Patient-Device Incompatibility14
Temperature Problem13
Electrical /Electronic Property Problem12
Therapeutic or Diagnostic Output Failure11

Raw counts of adverse event reports for this device type (FDA product code GZJ, NUH), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Planned maintenance checks

From the BMEssentia procedure library: every 12 months, about 15 minutes, electrical class II, applied part type BF.

CheckPass when
Unit and leads
Inspect the case, controls and lead wires.
No damage.
Output
Measure output into the load at low and maximum settings.
Within accuracy; no output above the maximum.

Test instruments: Oscilloscope and load resistor (500 Ω or the manufacturer's).

Standards engineers test against

IEC 60601-2-10: nerve and muscle stimulators

The particular standard for nerve and muscle stimulators, including TENS.

Recent FDA recalls

RecallProduct and reason
Z-1440-2012
2012-04-19
Synaptic Corp: Synaptic 3600 and 3800 with Cranial Electrical Stimulation manufactured by Synaptic USA, Aurora, CO.
Device was distributed without marketing approval. Root cause: PMA.
Z-2105-2011
2011-04-28
Neuro Resource Group Inc: Inter x 5002 Device, Inter x Professional Sport Device, Inter x 1000 Personal Device, and Inter x Personal Sport
Product package contains alcohol prep pads recalled by Triad Group because the prep pads have the potential to be contaminated with an objectionable organism. Root cause: Material/Component Contamination.
Z-1207-2007
2007-09-01
Avazzia, Inc: Avazzia Tennant Biomodulator
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications Root cause: Other.
Z-1208-2007
2007-09-01
Avazzia, Inc: Avazzia BEST-RSI
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications Root cause: Other.
Z-1209-2007
2007-09-01
Avazzia, Inc: Avazzia Med-Best Therapeutic Massager
Plastic Cases may crack due to manufacturing by the supplier not meeting specifications Root cause: Other.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 7 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

Learn it, see it in 3D, ask about it

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