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- The system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests. - The system can receive tests from a variety of devices. Data is then available through . onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries. - . Users may view and edit interpretative statements and measurements through the onscreen display. - The system can calculate multiple QTc metrics based upon acquired ECG data. ● - The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data. - . The system is designed to provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease. - The system is designed for use in a clinical setting by physicians, nurses, clinical . technicians, medical records personnel and medical record transcriptionists.

The Pyramis system is a personal computer based, comprehensive data management tool, with multi-tasking capabilities for receiving, editing, retrieving, and printing of ECG, Stress and Holter reports. The Pyramis system uses a transactional client/server database model with database transactional backup logging. User interface tools include bar coding, batch processing, on-screen diagnostic quality waveform viewing, customized header format, dynamic record retrieval and automated Quality Assurance reports on demand. Records can be accessed upon demand and transmitted remotely. The Pyramis system also uses industry standard protocols for communication so it can interface with the hospital's information system. The Pyramis system can be comprised of two functional components; the client application (user interface), and a suite of server applications that serve to acquire the ECG, Stress and Holter records, store them in a database and print/fax/email and export (distribute) those selected records.

The device is intended to monitor, analyze, document, and report hemodynamic data acquired during a cardiac catherization procedure. The system contains an acquisition subsystem and an analysis subsystem. The system acquires non-invasive and invasive data parameters. The data is received, displayed, stored, and analyzed in the Q-Cath. The device is to be used on adult and pediatric patients while undergoing a cardiac catherization procedure. Patient demographics, registration, patient assessment, procedure log notes, collected physiological and other Q-Cath data can be exported to an information management system. A Q-Cath remote workstation may be used to access patient files off-line or for the entering of additional patient information or editing of existing patient files. Additionally, the workstation may be used as a means of recording non-invasive vital signs data through the use of qualified third party peripheral monitoring devices. Multiple Q-Cath systems and workstations may be used and connected to a local area network. The Q-Cath system is not intended to be the sole means for monitoring a patient's status.

The Q-Cath system is a monitoring and analysis system that is used by Physicians, nurses, technicians and administrators associated with the cardiac catherization (cath) lab. The Q-Cath is a Microsoft Windows® based system with 32-bit architecture. The system contains an acquisition subsystem and an analysis subsystem. The O-Cath organizes patient signals (invasive & non-invasive), and non-physiological signals from external devices. The Signal Conditioning System (SCS) acquisition subsystem contains connectors for the 12 lead surface ECG, four pressure inputs, three HIS inputs, two DC inputs, two types of synchronization waveform outputs and ECG simulator outputs. The optional Vital Statistical System (VSS) acquisition system contains module connections for the non-invasive blood pressure, the SPO2 and two auxiliary modules. The analysis system generates data based upon pressure site locations, ECG data and the entry of information such as cardiac output, oximetry results, and the patient physiological condition. The system stores Full Disclosure data of all waveform data to the O-Cath local computer or can be stored off-line to a file server.

The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended population are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation.

The Q-Tel® Telemetry System v. 6.0 (ST) consists of a central receiver, transmitter, viewing monitor, keyboard, and accessories. ECG data is received via the transmitter to the central receiver and is displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.

The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

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The ViewCath™ Catheter Pullback is a device used for motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review.

The ViewCath™ Catheter Pullback is a medical Ultrasound Intravascular transducer catheter pullback device used in conjunction with Intravascular Ultrasound system devices. The ViewCath™ Catheter has a cradle that firmly holds various catheter transducer drive motors. Upon actuation, the device pulls the motor cradle at one of two selected speeds. A medical Intravascular Ultrasound catheter attached to the drive motor is pulled back at a consistent speed to obtain multiple 2-D ultrasound images. It is similar in design to other such catheter pullback devices. It has a motor driven mechanical screw mechanism, Intravascular Ultrasound catheter motor drive cradle, control switch and travel readout scale.

The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information. Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.

The CIS is a cardiology data management system that encompasses and integrates proprietary software and third party software on a single workstation or networked workstations. The workstation may include ancillary devices as a server, bar cod system, and printer. The CIS provides a means to establish, maintain, access, review, and edit cardiology patient records that are typically generated from ECG procedures.

The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.

The Vital Statistics System (VSS) is an accessory to the Quinton Q-Cath catheterization analysis system. The purpose of the VSS is to acquire, calculate, and transmit physiological data as blood pressure (acquired noninvasively), blood oxygen saturation data, and heart rate to the Q-Cath during cardiac cath procedures. Additionally, the VSS has 'pass-through' input and output connections for the purposes of acquiring and transmitting low voltage signal data to the Q-Cath from external devices and from the Q-Cath Signal Conditioning System component. Set-up of the VSS modules occurs at the Q-Cath via software controls. The VSS is made up of a 3" x 20" x 12" metal enclosure that has compartments for insertion of the non-invasive blood pressure module, SP02 module, and two pass-through modules. A power supply within the device is capable of converting line voltage to regulated low voltage needed by the modules. The VSS weighs 35 Ibs when all modules are in place within the VSS.

The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device for hemodialysis, apheresis, and infusion.

The Mahurkar 8 Fr Catheter, a radiopaque polyurethane tube with two D-shaped lumina, is coated with silicone fluid. The lumina can be distinguished by the colorcoded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return. The Mahurkar 8 Fr Catheter is available in four (4) implantable lengths (9 cm, 12 cm, 15 cm, and 19.5 cm), with straight extensions or curved extensions, and is packaged in catheter kit and catheter tray configurations.