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Device Lab 13

IVUS

IVUS in the BMEssentia 3D Device Lab

One piezoelectric element, six tenths of a millimetre across, cemented to the end of a flexible torque shaft and spun inside a sealed sheath at eighteen hundred revolutions a minute. It fires two hundred and fifty-six times per turn, so one revolution is one cross-sectional frame and thirty turns a second are thirty frames. The sheath stays still while the shaft inside it rotates, and the space between them has to be filled with saline, because a bubble of air in that gap reflects essentially the whole beam.

Also called: Intravascular Ultrasound. Arabic: الموجات فوق الصوتية داخل الأوعية. Device Lab 13 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Mechanically rotated single transducer

One piezoelectric element, six tenths of a millimetre across, cemented to the end of a flexible torque shaft and spun inside a sealed sheath at eighteen hundred revolutions a minute. It fires two hundred and fifty-six times per turn, so one revolution is one cross-sectional frame and thirty turns a second are thirty frames. The sheath stays still while the shaft inside it rotates, and the space between them has to be filled with saline, because a bubble of air in that gap reflects essentially the whole beam.

Solid-state phased array around the tip

Sixty-four elements in a ring around the catheter tip, with the multiplexer and the preamplifiers on a chip immediately behind them, because sixty-four coaxial cores will not fit down a one-millimetre catheter and a signal of a few microvolts will not survive being sent down them if they did. Groups of fourteen adjacent elements are fired together to form one beam, and the group is stepped around the ring electronically. Nothing moves, nothing has to be flushed, and the frame rate is whatever the electronics choose.

How it works: the main parts

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

Mains inlet, isolation and protective earth
An appliance inlet, a fuse, an equipotential stud and a rating plate on the back of the rack, and behind them a transformer whose entire purpose is to make sure that no fault anywhere in this machine can put a voltage on the conductor that runs to a transducer inside somebody heart.
Transmit pulser
A high-voltage switch that slams a few tens of volts across a piece of piezoelectric ceramic for about fifty nanoseconds and then stops, and then waits for eight microseconds doing nothing at all. On one configuration there is one of them.
Preamplifier and time-gain compensation
A low-noise amplifier whose gain climbs while it is listening, and on one of the two configurations it is not in the console at all, it is on a chip inside the catheter tip, a millimetre from the elements, because a signal of a few microvolts will not survive a metre of anything.
Digitiser
The most expensive board in the rack, and the reason this device costs what it does. A forty megahertz pulse two cycles long has a bandwidth to match, and sampling it faithfully means converting at a rate that most medical electronics never approaches.
Envelope detection, compression and polar scan conversion
The stage that turns a numbered series of echoes into a disc. It rectifies and smooths each line into an envelope, compresses a hundred and twenty decibels of amplitude into the thirty a screen can show, and then writes each line outwards from the centre at the angle the reconstruction believes it was taken at.
Cross-sectional display and measurement calipers
A screen showing a disc with a hole in the middle of it, and two tools for tracing a border on that disc and reporting the area it encloses. The number those tools produce is the deliverable of the entire device, and it is the number the one idea of this device is about.
Longitudinal display and pullback reconstruction
A second screen showing the vessel along its length, assembled out of the cross-sections by stacking one diameter from each of them side by side. It is the only view on this device that has a length in it, and that length is not measured.
Console control panel
A deck of keys, two rotary controls and a trackball, with a small strip above it showing the last area that was measured. Four keys matter: area, distance, bookmark and pullback, and the bookmark is the one that decides whether anybody can find the frame again.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Retraction Problem1,167
Entrapment of Device1,074
Poor Quality Image1,003
No Display/Image804
Detachment of Device or Device Component678
Air/Gas in Device477

Raw counts of adverse event reports for this device type (FDA product code OBJ, OWQ), 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 CF.

CheckPass when
Console and patient interface module
Inspect the console, the pullback unit and its connector.
No damage.
Electrical safety
Test to IEC 62353 (cath lab, Group 2).
PE ≤ 0.30 Ω; applied part CF ≤ 50 µA.
Pullback and recording
Run the pullback at each speed; record and export a test run.
Per manufacturer.

Test instruments: Electrical safety analyser.

Recent FDA recalls

RecallProduct and reason
Z-2379-2026
2026-06-13
ARROW INTERNATIONAL, LLC: Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. Root cause: Nonconforming Material/Component.
Z-1323-2026
2026-02-06
Medline Industries, LP: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters:
These lots of reprocessed catheters may contain small particles of residual material. Root cause: Under Investigation by firm.
Z-1324-2026
2026-02-06
Medline Industries, LP: Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:
These lots of reprocessed catheters may contain small particles of residual material. Root cause: Under Investigation by firm.
Z-1325-2026
2026-02-06
Medline Industries, LP: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters:
These lots of reprocessed catheters may contain small particles of residual material. Root cause: Under Investigation by firm.
Z-0573-2026
2025-11-20
Sterilmed, Inc.: Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM
Affected catheters were reprocessed beyond validated cycles. Root cause: Reprocessing Controls.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 33 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

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