Initial Situation

Brain injuries are among the leading causes of death and permanent disability worldwide. Real-time bedside monitoring of critical brain parameters, such as cerebral blood flow and brain tissue oxygen saturation, helps to identify warning signs early and make well-founded therapeutic decisions. Luciole Medical had developed a reliable neuromonitoring system, but it was the size of a control cabinet—far too large for the intensive care unit or operating room. The goal was to reduce it to the size of a palm while simultaneously meeting medical standards.

RheoControl Miniaturize white 01 2021

Project Overview

Client
Luciole Medical

Area
Medical & Life Science

Solution
Miniaturized neuromonitoring spectrometer.

System Environment
Four infrared lasers, waveguide technology, electrical detectors, FPGA, USB interface to the medical computer

Partners
Luciole Medical, University Hospital Zurich, University of Zurich, ETH Zurich

Medical Device
Class IIa, CE marked, Laser Class 1M

Deployment
In use in hospitals since 2017

The Contribution of SCS

SCS developed the miniaturized RheoControl spectrometer in collaboration with Luciole Medical, the University Hospital Zurich, the University of Zurich, and ETH Zurich. SCS supported the system from requirements engineering and system design through hardware and firmware to the certification process and production.

From Control Cabinet to Palm

Waveguide technology precisely combines the light from four laser diodes in a very small space. This allowed the spectrometer to be reduced to a fraction of its original size.

Optics and Electronics on One Board

The main circuit board combines the analog front end, optical components, and an FPGA. The FPGA controls the power and timing of the laser diodes and transmits the measurement data to the medical computer via USB. A separate protection circuit handles laser safety.

Developed for Medical Requirements

RheoControl is a Class IIa medical device. Key requirements included Class 1M laser safety and 4 kV electrical patient protection. Risk analysis, risk mitigation, and FMEDA were integral parts of the development process.

Multiple Measurement Points Simultaneously

Multiple RheoControl devices can be stacked and synchronized with each other. This allows vital parameters to be monitored simultaneously at several locations in the brain.

RheoControl LD Coupling

Result

RheoControl now requires only a fraction of the space of the original system and is fully controlled via USB. The spectrometer supports both the minimally invasive RheoSens probe and the non-invasive RheoPatch for different forms of neuromonitoring and has been in use in hospitals since 2017. SCS was responsible for significant parts of the development, including requirements engineering, system design, hardware, firmware, and software, as well as calibration tools, and supported the certification process and CE-compliant labeling in production.

Control Cabinet to Palm

Miniaturization to a fraction of the original space requirement.

Class IIa

CE-marked medical device.

Since 2017

In use in hospitals.

Services Provided

Electronic Hardware

FPGA Engineering

Regulatory / Medical Device Development

Medical & Life Science

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Your Contact Person

Beat Hörmann

Healthtech & Innovation
+41 43 456 16 00

For questions regarding medical hardware, miniaturization, and standards-compliant medical device development.

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