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Xper Flex Cardio Physiomonitoring System-The physiomonitoring system is intended for use by professional healthcare providers for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing. and analytical assessment. The system is indicated for use in the cardiac catheterization, following areas: cardiology, electrophysiology, radiology, invasive radiology and other areas where cardiac monitoring may be required. The system is not intended to be used in the proximity of magnetic resonance imaging. The data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device. Xper Information Management- The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data. such as physiologic/ hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multichannel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization. electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system is capable of receiving and displaying user-adjustable alarms (both visual and audible) available in the system, which alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended where unattended patient monitoring is desired, or in situations where arrhythmia detection is required. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a stand-alone device.

The Xper Flex Cardio physiomonitoring system and Xper Information Management systems are enhancements of the cleared Xper Information Management system (K063840). The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram), respiration, invasive pressure, SpO2 (pulse oximetry), end tidal CO2 (ETCO2) and non-invasive pressure waveforms; surface body temperature and thermal cardiac output curves. The system is capable of processing/analyzing information such as multi-channel ECG signals and displaying a graphical ST segment map. The Xper Flex Cardio physiomonitoring system makes measurements that assist physicians and other clinicians to evaluate a patient's overall cardiopulmonary performance, conductive system and general vascular status. The Xper Flex Cardio physiomonitoring system is not intended for use in the proximity of magnetic resonance imaging. The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices.

Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition, medical image/data processing, and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. Xper Information Management/Physiomonitoring 5 and/or 5 system, Patient Care Console and Central Station provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of Xper Information Management/Physiomonitoring 5 and/or Vascular 5 system, Patient Care Console and Central Station is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management Central Station and Patient Care Consoles are intended for complete physiologic monitoring, clinical data acquisition, medical image processing and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of Xper Information Management Central Station and Patient Care Console is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The Xper Information Management ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. The Xper ECG Management system does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. The Xper ECG Management system provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The Xper Information Management device is intended to be used for complete physiologic/hemodynamic monitoring and information gathering as well as medical image review through links to cleared devices. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device.

The modified device has the same intended use as the legally marketed predicate device. It is intended to be used for complete physiologic/hemodynamic monitoring and information gathering. It facilitates clinical data acquisition and analytical assessment for cardiac catheterization, invasive radiology and electrophysiology laboratories.

CALYSTO Image IV is an image and information management system intended for image data acquisition, archival, distribution, viewing and analysis for medical images of all modalities as well as Electrocardiogram (ECG) images. It's users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Image IV provides the ability to transmit patient data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet or internet, or may function as a stand-alone device. The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format. and made available for review and procedural report generation purposes. CALYSTO ECG Management System does not provide interpretive functions, but does store interpretive statements generated by the source device in an integrated and expandable database. Its users. responsible to interpret the data made available, will be professional health care providers. CALYSTO ECG Management System provides the ability to transmit ECG data files for storage, analysis and viewing at distributed locations within the clinical facility via intranet, or may function as a stand-alone device.

CALYSTO Image IV is an image and information management system. The CALYSTO ECG Management System is intended for receiving and storing resting, stress and holter ECG data from source devices.

The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.

The CALYSTO Series IV is intended for complete physiologic/hemodynamic monitoring, data acquisition and analytical assessment within any invasive clinical environment such as cardiac catheterization, invasive radiology and electrophysiology laboratories. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit patient data via intranet or internet, for storage, analysis and viewing at distributed locations, or may function as a stand-alone device. Use of CALYSTO Series IV is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Central Station and Patient Care Monitors are intended for complete physiologic monitoring, clinical data acquisition and analytical assessment within any healthcare environment. Its users, responsible to interpret the data made available, will be professional health care providers. The system provides the ability to enable alarms (both visual and audible), which alert the operator to potential patient distress and facilitate timely responses. Use of CALYSTO Central Station and Patient Care Monitors is not intended where unattended patient monitoring is desired or in situations where arrhythmia detection is required. The CALYSTO Series IV ECG Management system is intended for receiving and storing resting, stress and holter ECG data from source devices. ECG data is stored, unaltered, in its original format, and made available for review and procedural report generation purposes. CALYSTO Series IV does not provide interpretive functions, but stores interpretive functions generated by the source device in an integrated and expandable database. Its users, responsible to interpret the data made available, will be professional health care providers. CALYSTO Series IV provides the ability to transmit ECG data via intranet or internet, for storage, and viewing at distributed locations, or may function as a stand-alone device.

The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to provide continuous monitoring of patient physiological parameters, generate alarms (both visual and audible), alerting operator to anomalous occurrences and facilitate timely responses. The Witt Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including surgical intensive care, respiratory intensive care, coronary care, post anesthesia recovery, operating room, medical intensive care, pediatrics intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough display of monitoring parameters which use proven algorithms and are displayed in a logical, easily understood format that requires only familiarity to the users of any Witt Biomedical system. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended to be used by trained hospital personnel with training on the operation of this equipment.

Witt Biomedical Corporation Central Station with Advanced Patient Care Monitoring System.