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The Catalyst+ system and accessories are intended for use in radiation therapy clinics with treatment, to provide: - · Interactive guidance for setup and positioning of patients for radiation therapy - · Intra-fraction motion detection during radiation therapy - · Respiratory gating during radiation therapy The device is not intended for use in MR-linac systems. The system shall only be used by hospital personnel, qualified to work in radiation therapy departments. Training on the use of the system will be given to users at the time of installation.

The Catalyst product consists of projector unit hardware and Windows based software. The product is intended to be used in radiation therapy clinics for patient positioning, patient monitoring and respiratory gating. A 3D image of the patient surface can be acquired and compared to a reference image that was either imported from e.g. a treatment planning system, or acquired by surface scanning earlier. The Catalyst system computes the optimal couch correction as well as errors in the patient's posture. Measurements are done continuously using near UV light (405 nm). The detected errors are in parallel projected using visible light (red and green) in real-time e.g. as a distance map directly on the patient's surface to indicate which body parts that need to be adjusted and how. The rigid-body couch correction is projected numerically and can be sent to the couch control system to enable auto-setup of the couch. Once that patient is in the correct position, the Catalyst system will continue to monitor the patient during treatment delivery to ensure that it doesn't move out of position. If a large movement is detected, a warning can be issued for the personnel to react on, and/or an interlock can be triggered automatically to shut off the beam. For optimal coverage of the patient and to support couch kicks, two additional units (Catalyst* system without back projection) can be installed in an angle from the main unit. The configuration is called Catalyst+ HD/PT. The following application modules are provided: - cPosition - is the application module that provides a reproducible way of accurately positioning patients. It compares the current patient position with a reference setup bv using surface matching software for calculating adjustments in the patient's position. - cMotion - is the application module for supervising patient motion during treatment. During treatment the system shall record the patient's position continuously and signal or interrupt treatment when the patient is moving outside specified tolerance intervals. - cRespiration is the application module for respiratory tracking and gating. ● During treatment the module is able to give a warning or to turn the beam on or off depending on the acquired respiratory signal and on the gating parameters established in the treatment plan. The cRespiration in Catalyst* is based on reference data created in the CT room.

The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: · accurate and reproducible patient positioning. • a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the CT. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. On this surface the user, a health care professional, virtually marks where on the patient the respiratory motion signal shall be measured and in the next step, when the 4DCT imaging starts, the signal is measured with a frequency of around 16Hz. In general, the system is capable of acquiring more than 50 contours per second. The acquired 3D surface can also be exported and used as a reference image in the treatment room. The Sentinel system for the CT room is used in radiation therapy clinics to perform prospective or retrospective gated imaging (4DCT) prior to treatment. The system provides information about a patient's respiratory motion during the localization of the tumour in CT imaging. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the diagnostic procedure. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow. The software is designed to integrate with existing CT systems at the clinic. The Sentinel system does not require any markers to be placed on the patient or the couch and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the CT room during the whole set up procedure. Sentinel for the CT room includes the cRespiration module for respiratory gating during diagnostic CT imaging, so called 4D CT studies.

The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides: - accurate and reproducible patient positioning. . - patient motion supervision with an audible and/or visual alarm whenever . the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm. - a respiratory signal to be supplied to diagnostic imaging equipment . (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction. The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops. The Sentinel system does not require any markers to be placed on the patient or the couch, and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the treatment room during the whole set up procedure. Sentinel includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure and cRespiration for respiratory gating diagnostic CT imaging, so called 4D CT studies. Patient positioning before the actual treatment begins, together with subsequent motion detection, ensures that the patient's position is correct both before and during the whole treatment delivery. The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours are typically lowered so that the desired frame rate is achieved. The system is capable of acquiring more than 50 contours per second.

The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides, information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or treatment delivery.

The Catalyst system is a further development of the Sentinel system and is using the same software platform but contains a new hardware device which enables overall higher performance and the possibility to run multiple applications in parallel. Catalyst is an advanced system based on optical surface tracking for patient monitoring during the radiotherapy treatment process. The Catalyst platform is based on advanced structured light measurements with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops. Catalyst includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure, and cRespiration for detecting respiratory motion and generating a gating signal for synchronized imaging or gated treatment delivery. The Catalyst hardware consists of a single scanner unit containing the projector and camera, mounted in the celling in front of the gantry. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a sequence of structured light patterns is illuminating the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using the principles of optical triangulation. Information from the system is shown on a PC monitor in the treatment room as well as the control area. The system can also project a high resolution multi-color light field onto the patient surface, thus avoiding the need for the personnel to look at the PC monitor when setting up the patient. The system optionally records data which can be used for further analysis of actual patient motion during each treatment session.

The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment.

The Sentinel system is a new version of the Positioner system (previously registered with 510(k) Number K063839), updated with an application module for patient monitoring, cMotion (the design control documents are included in Appendices A and B). Sentinel is an advanced system for surface contour localization and patient monitoring during the radiotherapy treatment process. The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops. Sentinel includes two application modules, cPosition for fast and accuracy patient positioning and cMotion for motion detection during the treatment delivery procedure. The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software. During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours is typically lowered so that the desired frame rate is achieved. cPosition Once the treatment planning has been performed, the resulting plan can be transferred to the Sentinel system through import from the industry-standard DICOM format, creating the reference data necessary for patient positioning. Reference data can also be by created using the Sentinel laser scanner. In the treatment room, synchronization with the LINAC or R & V (Record and Verify) system ensures that the correct reference data is called up automatically when the patient is selected for treatment, and also eliminates the need for any manual selection of the patient in the Sentinel system. By advanced surface registration algorithms the actual patient position is compared to the predefined reference, suggesting within seconds a correction in six degrees of freedom of the patient's position. With interface to major accelerator vendors the suggested patient position is transferred to the respective couch control system and fast and accurate alignment is achieved. cMotion cMotion monitors the movement of the patient during treatment delivery and automatically warns if the patient moves outside the allowed tolerances.

The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

The system consists of a laser-camera unit (LS-100) mounted in the ceiling, and a Windows based application (cPosition) running on a standard PC. The system is non-invasive and uses visible laser light (635nm) to project lines on the patient. The laser-camera scans a 3D surface by projecting a series of laser lines which are recorded by the camera. From each camera recording a 3D contour of the measured object is calculated using triangulation technique and by adding the contours a full 3D surface image is achieved. The PC software compares the scanned image with a reference image and calculates the adjustments required in order to match the two images.