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The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions

The intended use of the Breast Coil is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and placement of localization-wire by a trained physician. For use with Siemens 0.55T, 1.5T, and 3T systems

These three models are known as specialty MRI coils for use in generating MRI images of the female breast. MRI procedures that include the evaluated device are conducted for clinical purposes at the discretion of the ordering physician. The Breast BI Coil Sets described in this document has been designed, depending upon model type, for use with an MRI system with field strength of 0.55T 1.5T or 3.0T. The coil system consists of pure receiving coils for the reception of high frequency signals from the hydrogen-('H)-nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRI device. The precise magnetization induces potential differences in the Breast Bl Coil Sets which are digitized and further processed in the MRI system. The Breast BI Coil Sets consist of a rigid Coil Frame with Immobilization, Biopsy and Breast Coil System. Imaging is performed with a 7-Channel "phased array" Coil developed and manufactured by the NORAS company. The coils are mounted in the rigid Coil Frame. Interconnection is handled by the software of the MRI. The Breast BI Coil Set 0.55T is an innovative concept designed to offer flexible use to meet the needs of the procedure to be performed in your clinic. It is removable and enables the biopsy device to be used with the respective corresponding coil with the different field strengths. The rigid Coil Frame forms a high resolution, 7-channel "phased array" configuration. The Coil Frame is made of fiberglass-reinforced polycarbonate. The surface has been finished with Alexit biocompatible coating. The breast cushion and the headrest are made of PE

The intended medical use of the OR Head Holder LUCY and Head Coil Set 1.57/3T is, in conjunction with a Magnetic Resonance Scanner, intra-operative MR imaging during an open-skull neurosurgery. The OR Head Holder LUCY is used for safe securing the patient's head during a surgical intervention at the head. It is possible to make an intraoperative assessment during the intervention to determine its progress. In the MR area the Head Coils enable the diagnostic imaging. Using Computed Tomography or C-arm Fluoroscopy, it is mandatory to remove the Head Coils and the device serves as a skull clamp only.

The OR Head Holder LUCY can be used for intra-operative MR Imaging, CT Imaging and C-arm Imaging. In use with the NORAS OR Head Coils 1.5T or 3T, the OR Head Holder LUCY can be applied for intra operative MR imaging during an open skull neurosurgery at human patients. The NORAS OR Head Holder LUCY is used for safe fixation of the patient's head during neurosurgical procedures on the patient's skull with planning and resection aid for MRI, CT and C-arm Imaging. One additional feature of the OR Head Holder LUCY is the ability of height adjustment providing an ideal patient positioning in 70 cm MRI (Siemens Magnetom Aera and Skyra and Philips Ingenia 1.5T/3T, Ingenia Ambition 1.5T and Ingenia Elition 3.0T) and in CT- Scanners. Furthermore, the whole set up can be moved parallel to the bore direction (in Z- direction). The configuration allows comfortable positioning of the patient in prone, lateral or supine position on the transfer board and allows an exact adjustment of the Head Holder during the positioning of the patient´s head. The system supports awake craniotomy. Mechanical, the model of the Head Holder allows a slight movement of both posts of the three-point fixation at the Arc with a stable geometry, which minimizes unwanted movements. The patients head will be fixed by three skull pins.

The intended use of Breast BI 7 MR Coil 1.5T Mammavention is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit permits MR guided breast biopsy and wire localization of lesions can be performed by a trained physician. The coil system Breast BI 7 MR Coil 1.5T Mammavention can be used with the following MRI systems: 1.5T: Siemens 1.5T: Avanto fit, Aera, Amira

The Breast BI 7 MR Coil 1.5T Mammavention described in this document has been designed, depending upon model type, for use with a SIEMENS MRI system with field strength of 3 T. The coil system serves solely as a receiving coil for the reception of high frequency signals from the hydrogen -(1-H) nuclei. The hydrogen nuclei are induced into precession by the transmitting coil of the MRT device. The processing magnetization induces potential differences in the Breast Bl 7 MR Coil 1.5T Mammavention which are digitized and further processed in the MRT system

For Siemens: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for use with the MR system MAGNETOM Aera / Skyra and the Combi-Dockable-Table together with Trumpf OR Tables TrueSystem 7500 (EU/US Version) and as well as together with Maquet OR Tables Magnus (EU/US Version) and Alpha Maquet Plus (EU/US Version). For Philips: The NORAS OR Head Holder Flexibility and the NORAS OR Head Coils 1.5T / 3.0T are used for intra-operative MR imaging during open-skull neurosurgery. The NORAS OR Head Holder is used for safely securing the patient's head during the intervention. The NORAS OR Head Holder Flexibility together with the NORAS OR Head Coil 1.5T / 3.0T are suitable for Philips MR system Ingenia 1.5T/3T in combination with Maquet Transfer Board together with Maquet OR table.

The NORAS OR Head Holder and the NORAS OR Head Coil 1.5T / 3.0T combine the functions of a head holder for neurosurgical interventions and an MR receiving coil for intra-operative surgery. The NORAS OR Head Holder without the NORAS OR Head Coil 1.5T / 3.0T can be used for stabilizing the patient's head. It can also be used in combination with the body coil. The Head Frame of the NORAS OR Head Holder allows adjustment to heads varying in size. For optimal access to the area of intervention, the Head Frame can be swiveled and rotated.

The intended use of the Noras OR Head Coil 3T 7230-PH is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). Used in the 3T Philips Achieva Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

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The intended use of the Noras OR Head Coil 3T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). Used in the 3T MAGNETOM Systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

The Noras OR Head Coil 3T is an 8-channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. Each-channel is tuned to the Larmor frequency of the 1H spin in a magnetic field of 3T, 123.2 MHz. Each coil is connected to the MAGNETOM system by a separate cable.

The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body. When interpreted by a trained physician, these images provide information that can be use in determining diagnosis. The application area shouldn't be bigger than 20 cm because of the depth of 10 om per coll. The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with sumilar structure can be taken.

The CPC is a multifuntional coil for 1 5T and 3T MRI-systems, with 2x4-channel phased array receive only colls. The coils are pre-tuned in the fixed load and no further tuning or matching is required for the user. The coll is divided into two spherical parts. Each half contains a 4 channel receive only array. The coils were used together with a parallel imaging procedure. Each coll has its own plug. The plug is specific to the MRI-system and can't be mixed up with a not designated MRI-system. The base plate is flat and is suitable on each Siemens MRI-system table.

The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis. The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.

The MR-BI320-PA 1.5T is a patient rest with a immobilization- and biopsy unit and a 4-channel phased array receive only coil. The coil is factory pre-tuned to the fixed load and no further tuning or matching is required for the patient. The coil is divided into two spherical parts. Each half contains a 2 channel receive only arrav. The upper coil is connected with a cable and a plug with the insertion coil. The insertion plate coil is connected to the scanner with a cable connection. The insertion plate coil is designed to enable insertion of immobilization and biopsy system and is inserted into the patient rest. The upper coil (patient pad coil) serves as a positioning pad for the patient at the same time.