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This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor. The monitored parameters are: 1. ECG 2. Noninvasive Blood Pressure (NIBP) 3. Invasive Blood Pressure (IBP) 4. Temperature 5. Respiratory Gases 6. Anesthetic Agent Gases 7. Respiratory Rate 8. Pulse Oximetry (SpO2) 9. Arrhythmia and ST Analysis of the ECG waveforms

The 9100 monitor measures and displays real time physiological data of the patient, including a graphical plethysmogram and numerical data. The 9100 is a modular system and can be used to monitor one or more of the following parameters: ECG, Noninvasive BP (NIBP), Invasive BP, Temperature, Respiratory Gases, Anesthetic Agent Gases and SpO2. Arrhythmia and ST Segment analysis of the ECG waveforms is also offered. For all these vital parameters, the 9100 will be capable of limit alarms and alerts, printing of strip chart recordings and storing trends for retrospective review.

Where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms. The intended use of the ST/AR cardiotach is to monitor a neonatal, pediatric, or adult patient's ECG for heart rate and produce events/alarms for one or two ECG leads. The cardiotach function is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR arrhythmia analysis algorithm is to monitor a neonatal, pediatric, or adult patient ECG's for heart rate and ventricular arrhythmias, and produce events/s] prms for one or two ECG leads. The arrhythmia analysis algorithm is capable of monitoring both paced and non-paced patients. The intended use of the ST/AR ST analysis algorithm is to monitor an adult patient's ECG for ST segment elevation or depression and produce events/alarms for all possible ECG leads. The ST analysis algorithm is capable of monitoring paced and non-paced adult patients. The intended use of the ST/AR QT/QTc analysis is for use by the physician in the risk assessment process indicated for neonatal, pediatric and adult patients with and without symptoms of arrhythmia. QT measurement is intended to be used by qualified health professionals in hospital or clinical environments. Composite QT (single or multi-lead derived) measures the interval only and is not intended to produce any interpretation or diagrosis of those measurements.

The modification is a software-based change that adds the following features: - Atrial Fibrillation alarm - Heart Rate configuration to short or yellow long alarm - Addition of messages indicating causes of invalid OT measurement

The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A is intended for multiparameter patient monitoring. The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/57M Compact Critical Care Monitor with L-CICU02 and L-CICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents*. (*Gan TJ, Glass P, Windsor A, Payne F, Rosow C, Sebel P, Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol, Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:808-15.) The S/5™ Compact Critical Care Monitor with L-CICU02 and L-CICU02A software is indicated for use by qualified medical personnel only.

The S/5TM Compact Critical Care Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The caregiver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Compact Critical Care Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5™ Compact Critical Care Monitor: L-CICU02 and L-CICU02A. L-CICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-CICU02. The S/5™ CCCM uses several types of plug-in measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification. The S/5™ CCCM is typically furnished with a module that measures ECG, invasive and noninvasive blood pressures, pulse oximetry and temperature. Modules are placed in the S/5™ Compact Monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5™ CCCM can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5™ CCCM is operated by a keyboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-CICU02 and L-CICU02A perform some module-related tasks like arrhythmia analysis. ST-value calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (REMCO) which is still directly connected to the S/5™ Compact Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The S/5™ Compact Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurement data is sent to the network for central station or monitor viewing. Trends can be sent via a network to a central computer for archiving.

The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients. With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions. Impedance Respiration measurement is indicated for patients ages 3 years and older. Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more. The monitor is indicated for use by qualified medical personnel only.

The Cardiocap 5 monitor is a multi-parameter monitor that is factory configured. The monitor provides basic hemodynamic monitoring of ECG, SpO2, Temp, NIBP and Invasive provides outs addition to the hemodynamic monitoring it can be configured with Gas monitoring which are: CO2, N2O, O2, Anesthetic Agents with agent identification and Patient Spirometry TM . The Cardiocap 5 monitor software available is for Anesthesia or Critical Care. The customer upon purchase for optimized use of monitor can select the software for application. In addition the Cardiocap 5 rev. B will offer other options and enhanced features. These features are the following: OSAT - Enhanced D-O Oximetry (SpO2) performance NSAT - Nellcor Oximetry XP w/2 temp - Invasive pressure with 2 temp feature Rec. w/2 key - Recorder with 2 direct key function Because the Cardiocap 5 monitor is factory-configured for cost-effectiveness and compactness, the parameters and optional thermal array recorder cannot be upgraded later. Software is upgradeable. Cardiocap 5 is based on the same state-of-the-art monitoring and user interface technology, including menu logic and alarm philosophy, as the S/5 monitors. The Cardiocap 5 can also be networked to the Datex-Ohmeda Network. The hemodynamic frame (F-MX) and hemodynamic with gases frame (F-MXG) both include ECG with ST analysis and impedance respiration, SpO2, 1 temperature, and noninvasive blood pressure. Invasive blood pressures (2 channels) and second temperature is an option for both models. Airway gas options are for hemodynamic with gases frame . The Cardiocap 5 monitor now extends its feature sets to allow flexibility of customerpreferred oximetry options. These new oximetry features replace the functionality of the original oximetry offering. (Only one oximetry option is available at a time.

The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients. Impedance Respiration measurement is indicated for patients ages 3 and up. Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up. The monitor is indicated for usc by qualified medical personnel only.

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The ESCORT-LINK® Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT® II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only. The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.

The modified ESCORT-LINK® Central Station Monitor Model 20500 is a Central Station Monitor comprised of a standard VGA display, a standard Personal Computer Base and an auxiliary base used to mount the network communications hardware. The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers. Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the central station on standard UHF telemetry frequencies. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring. The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment. The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.

The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition. ST Segment Analysis is intended for use in the adult population. The SC6000/SC6000P is not for home use.

The SC 6000 / SC 6000P Bedside Monitoring Series Enhanced with ST Segment Analysis is an updated software version of the SC 6000 / SC 6000P Bedside Monitoring Series. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the isoelectric point (baseline). This is the same algorithm that is used in the Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371). The hardware of the SC 6000 / SC 6000P (510(k) K944350) is unchanged. The ST Segment Analysis is not active when the SC 6000/SC 6000P is in the neonatal mode. The modified software (version VC0) is not compatible with all previously sold versions of the monitor. Therefore, a software upgrade will be offered to the owners of units with previous software revisions. No hardware changes are required for the upgrade.

The Acuity ST Analysis option is being incorporated into the Acuity central station (licensed with Arrhythmia and Full Disclosure) as part of a network system within the hospital environment or clinical setting. The ST Analysis option is intended to be used to provide real-time monitoring and alarms for ST segment deviations (from a reference beat) for patients with suspected heart disease or anomalies.

Acuity Central Station, Cardiac ECG ST Analysis Central Station Monitor

The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3" monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features. The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.