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SagiPlan is a Brachytherapy Treatment Planning System used by medical professionals. SagiPlan is used for the creation of treatment plans for remote afterloader based HDR brachytherapy. SagiPlan will calculate a proposed treatment course based on imported clinical images and other user entered data. SagiPlan also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. SagiPlan especially supports the SagiNova Brachytherapy Remote Controlled Afterloading Device from Eckert & Ziegler BEBIG GmbH.

SagiPlan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input manually entered by the operator. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) remote afterloaders. The main use of SagiPlan is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR). SaqiPlan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose. SagiPlan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the SagiPlan software to the brachytherapy afterloader radiation device. The SagiPlan software is intended to be used with the SagiNova and the MultiSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH. The SagiPlan System comprises subjoined listed subsystems: - . Personal Computer to execute the SagiPlan software. - . Monitor to visualise the treatment planning process. - . Keyboard to enter treatment data. - . Mouse to select objects on the screen The PC is used to execute the SagiPlan software and runs under Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.

The SagiNova "HDR afterloading systems are computer controlled medical devices that provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose. The SagiNova HDR afterloading system includes the following models: SagiNova®: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 25 channels SagiNova® S: Safe shielding suitable for a Co-60 or Ir-192 Source, Contains 5 channels SagiNova® Ir: Safe shielding suitable for a Ir 192 Source, Contains 25 channels SagiNova® Ir-S: Safe shielding suitable for a Ir 192 Source, Contains 5 channels These afterloading systems include the same treatment unit, applicators, and accessories. They differ in the type of radioactive source that can be accommodated within the shielded safe of the treatment unit and the number of allowed treatment channels. - The SagiNova and SagiNova Sare capable of accommodating a Co-60 or Ir-192 radioactive . source due to the tungsten and lead safe that is incorporated within the treatment unit. These sources (Co-60 and Ir-192) are nearly identical in construction and clinical performance but differ in half life (Co-60 = 1953.2 days, Ir-192=73.4 days) and maximum activity (Co-60 = 2.2 Ci, Ir-192=13Ci). - 0 The SagiNova Ir and SagiNova Ir-S can only accommodate an Ir-192, 13 Ci radioactive source within the lead safe that is incorporated in the treatment unit. The number of treatment channels does not interfere with the performance of the device or the size of the implant that can be treated, but strictly limits the number of channels that can be connected at one time. This difference was designed to provide the user with a system that meets their specific clinical requirements. For standard HDR brachytherapy, e.g. GYN treatment, the 5 channel systems (SagiNova S and SagiNova Ir-S) are sufficient. While clinics that routinely perform more complex HDR brachytherapy implants, e.g. interstitial treatment, the 25 channel systems (SagiNova "Ir) are required. The applicators and accessories are interchangeable between all SagiNova "models and are based on clinically accepted designs required for HDR remote afterloading brachytherapy treatment. The range of applicators includes: - Intracavitary GYN applicators for the treatment of the vagina, cervix and endometrium including o tandem and ovoid, ring applicators and vaginal cylinders. - . Interstitial applicators for the treatment of breast, prostate, and soft tissue including templates, needles and flexible catheters. - 0 Intraluminal applicators for the treatment of esophagus, lung, nasopharynx including molds, catheters and bougie tubes - o Intraoperative applicators for the treatment of tumor beds include needles, catheters, and molds - 0 Surface applicators for the treatment of skin surface and mucosa including flexible molds. The applicators are available for different imaging modalities including CT/MR and X-ray imaging. The applicators are securely connected to the SagiNova with specially designed transfer tubes or connectors. The transfer tube designs are based on the type of applicator to be connected to the treatment unit, e.g. "Easy Click" transfer tubes for plastic needles and catheters, Transfer Tubes for GYN applicators and metal needles and connectors for universal applicators. The different components of the SagiNova HDR remote afterloading system work together to provide safe and effective HDR brachytherapy treatment to physician prescribed treatment areas.

IsoSeed I25.S17plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated. IsoSeed I25.S17plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation as temporary implants. IsoSeed 125.S17plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed I25.S17plus.

IsoSeed I25.S17plus is a radioactive brachytherapy source intended for permanent as well as temporary implantation. IsoSeed 125.S17plus is a cylindrical sealed source containing radioactive lodine-125. The source is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. The radioactive iodine 1-125 is deposited as silver iodide (Agl) on the surface of a silver bar. The silver bar also serves as an X-ray marker. lodine-125 has a half-life of 59.41 days. It decays with 100% to Te-125 as a result of electron capture by the radiation of X-rays and y-radiation in the energy range up to 35 keV. The most commonly used activities used for implants are up to 1.045 mCi. Other source strengths for temporary applications are available up to 25 mCi. IsoSeed I25.S17plus is delivered non-sterile and must be steam sterilized by the user. The device is intended for single use, unless it is used as temporary implant without direct tissue contact.

HDRplus is a Brachytherapy Treatment Planning System used by medical professionals. HDRplus is used for the creation of treatment plans for remote afterloader based HDR and PDR brachytherapy. HDRplus will calculate a proposed treatment course based on imported clinical images and other user entered data. HDRplus also supports the evaluation of clinical images in calculating the local and global doses to organs at risk and target volumes. HDRplus especially supports the Multisource and Gynesource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEGIB GnbH.

HDRplus is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on imported medical images and the input entered by the operator. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote afterloaders. The main use of HDRplus is to calculate the required dwell times at the predetermined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR). HDRplus can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, HDRplus will calculate the optimal dose distribution for the turnor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from the HDRplus software to the brachytherapy afterloader radiation device. The HDRplus software is intended to be used with the Multisource and GyneSource Brachytherapy Remote Controlled Afterloading Devices from Eckert & Ziegler BEBIG GmbH. The HDRplus System comprises subjoined listed subsystems: - Personal Computer . It executes the HDRplus software. - Monitor . To visualise the treatment planning process. - Keyboard . To enter treatment data. - Mouse . To select objects on the screen The PC is used to execute the HDRplus software and runs under Windows XP Professional or Windows 7. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data. Accessory: Film Scanner The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant. Accessory: Printer The Printer allows for hard copy of the patients treatment plan and other stored data. Accessory: Pen Tablet The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor. Accessory: Touch Panel The Touch Panel acts as an alternative replacement for the user to outline more accurately and faster a contour on the monitor.

The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.

The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.

The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System. The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.