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Device Lab 42

EMG

EMG in the BMEssentia 3D Device Lab

A hand-held bipolar probe delivers a constant-current pulse over the nerve at the wrist, and a pair of surface discs over the muscle it supplies records what arrives. The same stimulus is repeated at the elbow, the two latencies are subtracted, and the surface distance between the two cathode positions, measured with a tape, on the skin, over a nerve that does not run straight, is divided by the difference. That quotient is the only number in the study that is a velocity, and it exists because there were two sites rather than one.

Also called: Electromyograph, Nerve Conduction. Arabic: جهاز تخطيط العضلات الكهربائي. Device Lab 42 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Surface nerve conduction study, stimulating at two sites

A hand-held bipolar probe delivers a constant-current pulse over the nerve at the wrist, and a pair of surface discs over the muscle it supplies records what arrives. The same stimulus is repeated at the elbow, the two latencies are subtracted, and the surface distance between the two cathode positions, measured with a tape, on the skin, over a nerve that does not run straight, is divided by the difference. That quotient is the only number in the study that is a velocity, and it exists because there were two sites rather than one.

Concentric needle electromyography, no stimulator

No stimulator and no second site. A concentric needle is put through the skin into the muscle and what it records is the potential of its core measured against its own cannula, a fifth of a millimetre away. The examiner looks at the trace and listens to the loudspeaker while the muscle is at rest, then while it is gently contracted, then while it is contracted hard, and moves the needle to a new position and does it again.

How it works: the main parts

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

Patient cable and input connectors
Individually screened leads from each electrode gathering into a clip on the limb and continuing as one jacketed multicore to the input box, with a separate heavier lead for the stimulator that is a different colour and runs on the other side of the patient. Nothing here amplifies anything.
Differential preamplifier and gain stage
A small box on a short boom at the patient’s side with the electrode sockets on its face, a few centimetres from where the leads come off the limb. Inside it are an instrumentation amplifier, one resistor that sets the gain, and a guard driver.
High-pass and low-pass filters
Two rotary selectors on the fascia, one for each end of the window, set differently for each of the three things this machine records. They are the settings most often left where the last operator put them, and the ones that most change what a reader sees.
Digitiser, sweep and timebase
A converter, a crystal, and a knob marked in milliseconds per division. Everything after this point in the machine is numbers, and the crystal is the reason a latency is a measurement rather than an estimate.
Display, sweep speed and sensitivity
A screen with a graticule, a knob marked millivolts per division and another marked milliseconds per division. Neither of them changes anything about what was recorded, and both of them change what a reader concludes.
Measurement cursors and the derived-values table
Two vertical markers, a baseline marker, a wheel to drive them, and a table beside the trace showing latency, amplitude, duration, distance and velocity. This is the component where the subtraction that the whole device exists for finally appears as a number.
Loudspeaker and audio monitor
A small cone behind a grille in the front panel with a volume knob beside it. On a nerve conduction study it is turned down and barely used.
Patient ground electrode
A single larger disc or strap on the limb between the recording electrodes and wherever the interference is coming from, with a green lead of its own. It records nothing, it measures nothing, and without it neither configuration works at all.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Device Operates Differently Than Expected22
Device-Device Incompatibility7
Defibrillation/Stimulation Problem6
False Negative Result6
Device Operational Issue5
Loose or Intermittent Connection5

Raw counts of adverse event reports for this device type (FDA product code IKN), 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 60 minutes, electrical class I, applied part type BF.

CheckPass when
Probes and leads
Inspect the stimulator probe, the footswitch, amplifier and leads.
No damage.
Electrical safety
Test the system to IEC 62353.
PE ≤ 0.30 Ω; equipment leakage ≤ 500 µA; applied part BF ≤ 5000 µA.
Stimulator output
Measure the delivered current into the load at low, mid and maximum settings.
Within the manufacturer's accuracy; stops at the maximum limit.
Amplifier and latency
Feed a known signal and check amplitude and the latency measurement.
Within the manufacturer's accuracy.

Test instruments: Signal simulator; Electrical safety analyser; Load resistor for stimulator output.

Standards engineers test against

IEC 60601-2-10: nerve and muscle stimulators

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

IEC 60601-2-26 and IEC 60601-2-40: EEG and EMG equipment

IEC 60601-2-26 covers electroencephalographs; IEC 60601-2-40 covers electromyographs and evoked response equipment.

Recent FDA recalls

RecallProduct and reason
Z-1935-2010
2010-06-30
SpineMatrix Inc: Lumbar Matrix Scan, Diagnostic Electromyography System consisting of the CERSR Electromyography System and Electrode
A full design review of the CERSR system was conducted in 7/2009. Root cause: Device Design.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 1 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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