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The TrendCare Calibrator is an accessory for use with the TrendCare Monitors. Sensors and Patient Data Modules calibrated with the TrendCare Calibrator may be used with the TrendCare Satellite Monitor (TCM6000) or TrendCare Senior Monitor (TCM7000).

The TrendCare Calibrator is a microprocessor-based device powered from the mains (line) supply. The device incorporates: - A LCD display for user prompts. - A series of LEDs for system status indication. - Keys for selecting and initiating calibration. - Calibration chamber. - Connections to calibration gas cylinders. - Location fixtures for the multiparameter sensors. The calibration chamber is located on the front of the Calibrator unit, and is opened by pressing the latch to release the door. The sensor is calibrated by connecting it to the PDM patient cable, placing the tonometer in the calibration chamber, closing the door and securing the introducer, and pressing the START CAL key. A three point calibration of the sensor is performed by bubbling three precision mixtures of oxygen, carbon dioxide and nitrogen in sequence through the tonometer solution surrounding the sensor. These gases change the partial pressure of oxygen and carbon dioxide and the pH in the tonometer to defined values. The calibration gases are contained in cylinders located at the base of the Calibrator. The cylinders are identical to the predicate device. Each cylinder contains a different precision mixture of gases. These gases are automatically passed in sequence through the tonometer when the calibration sequence is initiated. Each of the cylinders contains sufficient gas for multiple calibrations. The cylinders are disposable, and should be discarded when empty (see the Instructions on the cylinder labels).

The CODMAN Neurotrend Cerebral Tissue Monitoring System measures Intracranial oxygen, carbon dioxide, pH and temperature, and is intended as an indicallarial oxygon, and in these parameters, indicating the perfusion and metabolic acidosis/alkalosis status of cerebral tissue local to sensor placement. metabolic academand values are relative within an individual, the Neurotrend should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia/ischaemia is a concem.

The Neurotrend Sensor (C7004S) is a modified version of the Fluorescent Paratrend 7 sensor which has been cleared for the US Market (K953893). The measurement parameters for Neurotrend are essentially the same as the Fluorescent Paratrend 7. The sensor does not require a heparin treatment, as a consequence of the application - to monitor cerebral tissue and fluid gas parameters.

The Neotrend Multiparameter Sensor is inserted via an intravascular access device into the vascular system, e.g. umbilical artery (neonates), femoral artery (paediatrics, adults). It is intended to be used in the management of critically ill patients of any age, but especially neonates, by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Neotrend sensor is designed for use in conjunction only with the custom umbilical artery catheter supplied when the umbilical artery is to be the access site. The sensor is used in conjunction with the Paratrend 7 Multiparameter Senior and/or Satellite Monitor systems. Within the United states market, the use of this device should be limited to 72 hours.

The Neotrend Sensor (N7004S) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Neotrend device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The application has been expanded to include umbilical artery access.

The Paratrend 7+ System is intended to be used in the management of the critically ill patient by providing continuous blood gas data while permitting the simultaneous monitoring of blood pressure via an external transducer. The Paratrend 7+ Multiparameter Sensor is inserted via an intravascular access device into the vascular system (e.g. radial, femoral arteries). Within the United States market, the use of this device should be limited to 72 hours.

The Paratrend 7 Plus Sensor (MPS7004P) is a modified version of the currently legally marketed device, the Paratrend 7 sensor (MPS7004). The measurement of pO2 using an electrochemical sensor (Clark electrode) in the predicate Paratrend 7 sensor has been replaced in the Paratrend 7 Plus device by a sensor based on optical fibre/fluorescence quenching technology. All other measurement parameters are essentially unchanged. The telescopic introduction mechanism in the predicate Paratrend 7 sensor has been replaced by a rotary advancing mechanism. The application has been expanded to include venous access.