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The Allura Xper FD OR Table series is intended for use on human patients (within the limits of the used OR table) to perform: • Vascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis, · Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiclogy (EP). · Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures, Combined with a qualified, compatible OR table, the Allura Xper FD OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.

The Allura Xper FD OR Table series is a modular X-ray systems series, based on a set of components that can be combined into different single and biglane configurations to provide specialized anglography. It is identical to the Allura Xper FD systems series, to which a qualified, compatible OR table component is added. These Allura Xper FD OR Table series X-ray systems are Angiographic X-ray Systems consisting of 1 or more of the following components: X-ray generator, X-ray tubelhousing assembly, beam limiting device, image receptor. X-ray control, frontal/lateral stand, patient support and a monitor ceiling suspension.

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless. Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation. Non-invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early. Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level. Non-invasive Blood Pressure Monitoring: The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure. End-tidal CO2: The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate. 12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements. Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time). The Q-CPR option is contraindicated as follows: - The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg). - The Q-CPR option is not for use when CPR is contraindicated.

The name of this device is the HeartStart MRx Monitor/Defibrillator with IntelliVue Networking Software Release 7.01. The modification is a change that provides network connectivity via the Philips IntelliVue Network.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alparming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50. are additionally intended for use in transport situations within healthcare facilities. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpC02) is restricted to neonatal patients only.

The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors. The modification is the introduction of Release E.01 software for the IntelliVue patient monitor devices.

Indicated for use by health care professionals whenever there is a need for monitoring, recording and alarming of multiple physiological parameters of patients. Intended for monitoring, of multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp02 / tcpCQ2) is restricted to neonatal patients only.

The names of the devices are the Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 IntelliVue Patient Monitors.

Philips Orthopaedic Applications is a suite of software applications designed to assist medical professionals such as orthopaedic surgeons, physicians and radiologists in planning and evaluating orthopaedic procedures using medical images. The applications are intended to view and manipulate 2D and 3D medical images; to calibrate and make length, angle and area measurements on such images; to represent and manipulate surgical planning templates overlaid on such images; to plan and simulate the effect of treatments by transforming such images; and to print and store the results of these measurements and simulations.

The Philips Orthopaedic Applications software runs on "off the shelt" standard PC components using a Microsoft Operating System. It can be used as stand-alone SW applications or as a Plug-in on advanced image processing workstations or review workstations (PACS). These applications provide digital alternatives for the tools medical specialists are used to work with when using conventional images printed on film: callipers, pencil, transparent sheets, scissors and tape. The software tools transform these conventional tools for working with digital images on a computer display.

PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

The PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).

The Allura Xper FD20 is intended for: - · Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, " e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolyses. - · Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP), - Non-vascular interventions such as drainages, biopsies and . vertebroplasties procedures.

The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascular, neurovascular and cardiovascular procedures, as well as non-vascular procedures.

The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.

The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on digital storage media, video or laser hardcopy.

The indication for use for the Transmit/Receive Quadrature Body Coil 3.0T expands the INTERA 3.0T system capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

The Transmit Receive Quadrature Body Coil 3.0T is a bird-cage type transmit/receive coil designed for use in the Intera 3.0T system. In transmit mode the coil is used in almost every kind of scan. In receive mode the coil is mainly used for imaging with a large field of view. The QBC has a fixed position inside the gradient coil.