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Open-Motion Research User Manual

Document ID: LBL-00014 · Revision: A · Software: v1.5.4 · Released: 2026-10-29 Authors: Brad Hartl, Ethan Head, Peter Herzlinger, David Paribello

Research use only

Read before you operate

The Open-Motion platform is for research use only. Not for use in diagnostic or therapeutic procedures. It is intended to be used by trained research professionals to measure changes in blood flow and blood volume.

Read the complete manual before operating the device.

If the fiber optic connections are disconnected or not properly secured to the Console, Class 3B laser energy may be emitted from open ports, which can cause serious eye injury. Never open the Console, and always power down and unplug it before disconnecting the Sensor Module cables.

Operating the device without the delivery optic diffuser in contact with the subject's skin may expose the eyes to laser radiation above Class 1 limits. Verify the diffuser optic is present, intact, and in contact with skin before every scan.

What this document is

The User Manual is the operator-facing reference for Open-Motion. Where the Developer Documentation explains how the platform is built, this manual explains how it is run: the safety envelope, installing and starting the Open-Motion Research application, placing the Sensor Modules, running and reviewing scans, 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-00014 Rev A (PDF, 59 pp.) Latest software release

Contraindications

Do not use the Open-Motion device on subjects with any of the following conditions:

  • Open cuts, sores, or wounds within the contact area
  • Head dressings, bandages, or gauze on or around the scan site
  • Inability to remain stationary for the duration of the measurements

Research use

Use of Open-Motion 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 operator to be aware of and comply with all applicable laws and regulations pertaining to their particular indication.

Provided as-is

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

What's inside

Section Covers Page
Introduction Device description, indications for use, contraindications, research-use boundaries, definitions (BFI, BVI, Mean, Contrast, P-SCOS), device labels and symbols 4
Safety Quality standards the device was designed to conform to (ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 60825-1); warnings, precautions, electrical safety, laser safety 6
System Specifications Console, Sensor Module, laser, and user-provided PC requirements 11
System Components Console ports and status LED, Sensor Module and camera ordering, storage and handling 13
Using Open-Motion Installing and updating the application and firmware, setup, assembling the Sensor Module frame, placing the Sensor Modules, scan settings and camera patterns, contact-quality checks, running a scan, reading and navigating plots, session notes, Scan History, settings, data storage, shutdown, cleaning, sync, getting help, known issues 15
Service and Maintenance Support contact and service agreement routing 46
Troubleshooting Common errors, on-screen messages, the error dialog, and the error code reference (E-101 through E-306) 46
Appendix: Sensor Module Replacement Connecting the hybrid cables of new or replacement Sensor Modules to the Console 52
For See
Getting set up and running your first scan Quick Start Guide
Hardware architecture and specifications The Open-Motion System
Synchronizing Open-Motion with another instrument External Connectivity
Building on or extending the platform Software Development
Installing the application Latest Software Release
Evaluating optical blood-flow platforms Evaluating Optical Blood-Flow Platforms

Cleaning

With the system powered off, clean the Sensor Modules and the Console with 70% isopropyl alcohol (IPA) and a lint-free cloth, in accordance with your facility's protocols. The disposable headband assembly (attachment frame and strap) is single-patient-use: discard it after each patient and do not clean, disinfect, reprocess, or reuse it.

Subject data

Use a study or subject code in session labels and notes — never a name or other subject-identifiable information. In the Research build the scan database is not encrypted; protect the computer and any exported files according to your study's data-handling rules.

Service and support

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

This page reflects LBL-00014 Revision A, software v1.5.4, released 2026-10-29 (ECO-000389). All information — including product features, specifications, and descriptions — is subject to change without notice. For the controlled revision, use the PDF.