Essentia Try Essentia

Essentia / Devices / Urodynamics System

Device Lab 43

Urodynamics System

Urodynamics System in the BMEssentia 3D Device Lab

Two fluid-filled catheter lines to two external transducers on a common levelling bar on the pole, each with a three-way tap to atmosphere for zeroing, a slow flush to keep the lines patent, and a rectal balloon catheter charged with a small volume of fluid or air. The reference level is established once, by putting both diaphragms at the same declared height, and every pressure in the study is quoted against it.

Also called: Urodynamics. Arabic: نظام ديناميكا البول. Device Lab 43 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Fluid-filled lines with external transducers

Two fluid-filled catheter lines to two external transducers on a common levelling bar on the pole, each with a three-way tap to atmosphere for zeroing, a slow flush to keep the lines patent, and a rectal balloon catheter charged with a small volume of fluid or air. The reference level is established once, by putting both diaphragms at the same declared height, and every pressure in the study is quoted against it.

Catheter-mounted tip transducers

Pressure sensors mounted on the catheters themselves, one facing the bladder lumen and one on the rectal catheter, each with its own bridge amplifier and its own calibration. There is no fluid line and no external diaphragm, so there is no tap to open to atmosphere at the measuring site and no levelling bar to set. An air-charged catheter, where a small balloon at the tip is coupled to an external sensor through a gas column, sits between the two configurations and is recorded in the dossier as a variant rather than as a third configuration.

How it works: the main parts

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

Vesical filling and measuring catheter
A fine tube, a little over two millimetres across and a few hundred millimetres long, with two separate passages inside it and a moulded hub at the outside end where the two separate. One passage delivers fluid into the bladder.
Abdominal line and its rectal balloon
A thinner tube than the vesical one, with a single passage, ending in a small soft balloon a centimetre or so across. It is the channel that makes the whole measurement possible, and it is the component most often treated as an accessory to the interesting one.
Catheter fixation and the drape window
Adhesive tape, two strain reliefs and one rectangular opening in a sheet. Nothing about it is electronic and nothing about it is optional, because every pressure in the study is quoted against a geometry that this is the only thing holding still.
Peristaltic filling pump and its rate
A small rotating head clamped to the pole, with three rollers on a rotor pinching a length of soft tube against a curved race. Turn the rotor and each roller pushes a sealed pocket of fluid along the tube.
Filling line, warming and the infused-volume count
A length of tubing from the reservoir to the catheter with three things in it: a chamber where drops are visible, a warming section, and a clamp that can stop everything by hand. Plus the count of how much has gone in, which is not an object at all and is one of the two most important numbers in the study.
Irrigant reservoir and its hanger
A bag of sterile fluid on a hook on the pole, with graduations up one side. It is the simplest object on the machine and it carries the one number in the study that nothing electronic produced.
Vesical pressure channel
Everything between the pressure inside the bladder and a number on a screen: a pressure path, a sensing element, a calibration that turns a bridge voltage into centimetres of water, a filter, and a converter. On this device it is one half of a subtraction, which means its accuracy matters much less than its comparability.
Abdominal pressure channel
The same electronics as the vesical channel, doing the same job, on the other cavity. It is the channel that gets less attention, and almost every failure of the subtraction is a failure of this one or of its relationship to the other.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Deflation Problem11
Leak/Splash11
No Flow10
Device Operates Differently Than Expected10
Calibration Problem5
Partial Blockage5

Raw counts of adverse event reports for this device type (FDA product code FEN, EXQ), 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 45 minutes, electrical class I, applied part type BF.

CheckPass when
Transducers, pump and flowmeter
Inspect transducers, lines, the infusion pump and the flowmeter.
No leaks.
Electrical safety
Test to IEC 62353.
Within limits.
Pressure and flow accuracy
Apply reference pressures to each channel; pour a known volume through the flowmeter.
Within the manufacturer's accuracy.

Test instruments: Pressure reference (water column or calibrated manometer); Calibrated volume and scale for the flowmeter; Electrical safety analyser.

Recent FDA recalls

RecallProduct and reason
Z-2076-2019
2019-07-17
LABORIE MEDICAL TECHNOLOGIES, CORP: U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. Root cause: Nonconforming Material/Component.
Z-2744-2018
2018-07-03
ConvaTec, Inc: AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient mount: a) REF ABV300, b) REF ABV301
Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier. Root cause: Nonconforming Material/Component.
Z-1711-2009
2009-07-21
Laborie Medical Technologies Cor: Laborie Medical Technologies Urodynamic Catheters, Twin Lumen 6 Fr , 40cm For Cystometry. Catalog Number: CAT-206.
Laborie Medical Technologies reports that there was a mix up in the labeling and packaging of their Urodynamic Catheters. Root cause: Packaging process control.
Z-0229-2007
2006-12-01
Laborie Medical Technologies: Laborie Transducer Cartridge with Luer Lock
Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. Root cause: Other.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 4 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

Previous: EMG. Next: Oesophageal Manometry. All 69 devices.

Ask about the Urodynamics System

Sign in with your BMEssentia account, or create one, and ask anything about this device.

Ask Essentia