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Open-LIFU User Manual

Document ID: LBL-00009 · Revision: A · Software: v1.21.1 (Slicer extension), v1.12.1 (Desktop application) Authors: David Paribello, Peter Hollender, Seemal Tahir, Muhammad Zubair

Research use only

Read before you operate

The Open-LIFU platform is for research use only. Not for use in therapeutic procedures. The System is not intended to be used for the diagnosis or treatment of any disease or medical condition and is not cleared by the FDA for clinical use.

This system is only intended to be used and operated by trained research personnel. Read the complete manual before operating the device.

Creating or modifying protocols without properly validating them may result in unsafe ultrasound exposure, leading to serious bodily harm. Use only approved and tested protocols.

The transducer is not watertight. Never submerge it in water. Damaged or compromised transducer housing may lead to high-voltage leakage and electrical shock risk — inspect all enclosures before powering on.

What this document is

The User Manual is the operator-facing reference for Open-LIFU. Where the Developer Documentation explains how the platform is built, this manual explains how it is run: the safety envelope, the end-to-end software workflow from subject creation through sonication, and what to do when something goes wrong.

It is a controlled document. The PDF below is the authoritative revision — this page summarizes and routes into it.

Download LBL-00009 Rev A (PDF, 86 pp.)

Contraindications

The following conditions are contraindicated when using the Open-LIFU platform; users or individuals displaying these signs or symptoms should not use Open-LIFU:

  • Open cuts, sores, or wounds within the transducer contact area
  • Head dressings, bandages, or gauze on or around the scan site that may interfere with transducer coupling
  • Subjects must be able to remain still for the duration of a procedure
  • Prenatal and Obstetric applications
  • Targets requiring a beam path that travels through eyes

Research use

Use of Open-LIFU to perform pre-clinical and/or clinical research may be subject to various domestic and international laws and regulations. It is the responsibility of the customer to be aware of and comply with all applicable laws and regulations pertaining to their particular use.

Provided as-is

While Openwater has endeavored to design Open-LIFU with predictable performance and documented safety features, Open-LIFU is provided as-is without warranty. The safety and efficacy of Open-LIFU for any particular use is inherently subject to the specific requirements and risks of that application, and assessment and mitigation of such risks is the sole responsibility of the user.

What's inside

Section Covers Page
Device Description & Indications What the system is, research-use boundaries, contraindications 5
Definitions Canonical vocabulary — Protocol, Session, Solution, Run, Photoscan, Virtual Fitting 6
Safety Quality standards the device was designed in accordance with (ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366); general safety, warnings, precautions, electrical safety 7
System Specification Console, console specs, transducer configurations, coupling pad, software, sonication sequence specs 15
Creating & Editing Sonication Protocols Pulse, sequence, focal pattern, beamforming, segmentation, constraints, virtual fit 21
Software Operation Database selection, log in, protocol configuration 37
Planning Workflow Subject selection, session start, target selection, virtual fitting, saving a session plan 42
Sonication Workflow Subject prep, photocollections and photoscans, transducer localization wizard, solution generation and approval, sonication, monitoring 50
Device Cleaning and Storage Coupling pad disposal, transducer cleaning limits 75
Administration and User Management Admin, operator, and custom roles; account management 75
Service and Maintenance Support contact and service agreement routing 78
Troubleshooting Photogrammetry reconstruction, offline/online connection failures, ADB setup 79
For See
Setting the device up for the first time Quickstart Guide (LBL-00007 Rev 2) — currently distributed in the onboarding packet; page pending
Full protocol parameter reference Creating & Editing Sonication Protocols (ER-00017)
Hardware architecture and specifications The Open-LIFU System
Acoustic output verification Water Tank Testing (ER-00016)
Building on or extending the platform Software Development

Cleaning limits

Do not press directly on or apply excessive force to the transmit module array. Do not clean the transducer by submerging it. Do not use isopropyl alcohol — it damages the photogrammetry patterned veneer. Use CaviWipes or a damp cloth on the exposed transducer faces, and dispose of the coupling pad per your institution's protocols.

Service and support

Service and maintenance must only be performed by suitably trained individuals.

This page reflects LBL-00009 Revision A. All information — including product features, specifications, and descriptions — is subject to change without notice. For the controlled revision, use the PDF.