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The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The 3160 MRI Patient Monitoring System is intended for use by health care professionals.

The 3160 MRI Patient Monitoring System is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. It is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving Magnetic Resonance environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MRI area. Built on Invivo's strong heritage in MRI patient vital signs monitoring, the 3160 orovides accurate, continuous, and reliable performance during all phase of MRI applications.

The Vision Telepak™ Telemetry Transmitter is portable monitor intended to be used for monitoring vital signs on critically ill adult and pediatric patients in the hospital environment.

The Vision Telepak Telemetry Transmitter unit is a portable, wireless, patient monitor intended to be used for monitoring the ECG and SpO2 vital signs of critically ill and pediatric patients. The Telepak unit is used in all areas of the hospital which utilize telemetry transmitters for ECG and/or SpO2 monitoring. The Telepak transmits vital sign information to an ESCORT Vision Central Station or an ESCORT Series bedside monitor. Both the central station and beside monitors were cleared under K970763.

The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner.

The Philips Medical Systems Integrated Patient Monitoring System (IPMS) is a significant modification of the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System. This device has been integrated into the Philips Physiotrak patient gurney used with the Philips MRI System. The Philips Medical Systems Integrated Patient Monitoring System is intended to monitor the heart rhythm and other vital signs for a patient undergoing an MRI procedure and to provide signals for synchronization for the MRI scanner. The IPMS works on DC (battery) power supplies and monitors ECG, non-invasive blood pressure, SPO2, respiration and temperature. This information can be displayed either at the monitor or remotely. The monitor sounds an alarm if any monitored parameter falls outside the range indicated by the alarm limits. The alarm limits is programmable either manually or programmally based on the current value of the parameter(s). This monitoring system is MRI-compatible. It utilizes technology from the Invivo Research Omni-Trak™ 3150/3155 Series Patient Monitoring System and the Invivo Research Millennia Patient Monitor. The IPMS consists of three major component parts; the MCB (Patient Connector Box), MEB (Monitoring Electronics Box), and MDCU (Monitoring Display and Control Unit) which are integrated into the Phillips Physiotrak patient gurney.

The Invivo Research Inc. Magnitude™ 3150M MRI Monitor is intended for general hospital or clinical use within a magnetic resonance imaging (MRI) area by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents monitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide, oxygen gas concentrations, ECG, non-invasive blood pressure, invasive blood pressure and temperature. This device is available for sale only upon the order of a physician or other related licensed medical professional.

The 3150M Fiber-Optic Temperature option enables the measurement of a patient's surface temperature both safely and accurately during all MRI procedures. This option utilizes a fiber-optic cable for interface between the temperature sensor at the patient application site and the measuring device. With this scheme, light channeled through a fiber-optic cable is the medium of temperature measurement rather than electrical conductor based components. The fiber-optic cable is impervious to the RF energy present during MRI procedures, thus eliminating the possibility of heating. The Fiber-Optic Temperature option contains four items: 1) Re-usable fiber optic surface temperature sensor. 2) Disposable surface temperature sensor applicator for use on patients ranging from Neonatal (5 kilograms) to Adult. 3) Fiber optic connector on the outside of the 3150M. 4) Signal conditioner inside 3150M patient monitor.

The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients' cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The Centurion™ Central Station with Arrhythmia Monitoring System is a Central Station monitor comprised of a standard VGA display, a standard Personal Computer (PC) base system, and hardware used to install the Network communications system (i.e. spreadspectrum transponders and UHF telemetry receivers). The Centurion™ Central Station with Arrhythmia Monitoring System can provide the centralized display, storage and recording (or printing) of patient vital sign and waveform data that is being monitored at the Invivo Research Inc. Millennia 3500 Series bedside monitors or spread-spectrum/UHF telemetry receivers. Data accumulated at the Millennia 3500 Series bedside monitors is sent via a proprietary spread-spectrum LAN (local area network) to the Central Station for display, storage, and/or printing. Data accumulated from any of the Invivo Research Inc. telemetry transceivers is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activities, allowing each system component to pass information along without interruption of patient monitoring. The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients. The Central Station alarm capability supplements the existing bedside monitor alarm capability (alarms at both locations). The Central Station can provide storage of patient data for 8 patients for up to 24 hours. This includes waveform and patient parameter data for all available parameter values. The waveform and parameter data that has been stored in a patient file at the Central Station can be retrieved and reviewed on the display or printed out on a thermal array recorder or laser printer.

The Invivo Research Inc. Millennia 3500 Series Monitor with Anesthetic Agent monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor concentrations of anesthetic gases. The agents whonitored include halothane, enflurane, isoflurane, sevoflurane and desflurane. Additionally, this monitor also monitors end-tidal carbon dioxide, nitrous oxide and Additionally, this more and to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. This device is available for sale only upon the order of a physician or other related licensed medical professional.

The Millennia 3500 Series Monitor with Anesthetic Agents Monitor is a patient monitor which draws a continuous flow of sample gas from the patient's anesthesia breathing circuit. The sample is then drawn through a measurement sample cell where the agent(s) and other patient gas concentrations are measured. Measured values are displayed as numbers and waveforms on the main display of the monitor. The monitor is operated by controls on the front panel of the monitor. The major functional subsystems of the device are the power supply, the pneumatic system, the measurement sample cell, the system electronics and product software. Power is supplied by an AC power cord, or an internal set of batteries. AC power is internally conditioned by the power supply subassembly, which powers the system and charges the internal batteries. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the sample cell, which is a cavity within the optical bench assembly. The sample is then exhausted out the rear of the unit. The sample cell cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of infrared light absorption. The infrared light source consists of a resistive element which radiates a relatively wide spectrum of infrared light. The amount of transmitted infrared light is measured by an optical detector, and several optical filters are used to determine the identity and concentration of the anesthetic agents, nitrous oxide and carbon dioxide. The oxygen measurements are obtained using a polarographic oxygen cell which also receives sample gas from the sample cell. The electronic system consists of an analog circuit board, and a digital circuit board. These boards are added to the existing standard Millennia 3500 Series Patient Monitoring System. The analog board takes the electrical signals from the sample cell assembly and conditions them so that measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agents and patient gases in the sample gas.

This device is intended for use as a patient vital signs monitor during magnetic resonance imaging (MRI) scans. It is intended to be used by or on the order of a physician or similarly qualified health care professional. This device is intended for use in the hospital environment (MRI, Radiology Clinic, or similar settings). This device is not intended for home use. This device includes the capability for monitoring the following patient parameters: - ECG . Heart Rate . Pulse Oximetry . Non-Invasive Blood Pressure ● . Invasive Blood Pressure End-Tidal Carbon Dioxide / Nitrous Oxide . Respiration effort . . Rra

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