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The Fusion™ System and accessories blood pressure measurement system is intended to be used on patients with wrist circumference of 11 cm - 22 cm by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure and pulse rate. The Fusion System module option of Nellcor OxiMAX Option (K012891), is indicated for the continuous non-invasive monitoring of a patient's functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel. The Fusion System module option of Kendall Genius Thermometer (K920713) is indicated for the measuring of a patient's body temperature. This device is prescription use only.

The Fusion™ System is a non-invasive blood pressure monitor that uses a pressure sensor placed directly on top of the radial artery. This sensor is noninvasive and eliminates the need for an occlusive inflatable cuff. This device is intended to be used on patients by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure, and pulse rate. The Fusion™ System uses a patented "sweep technique" which applies a varying force on the radial artery. The counterpressure in the artery produces a signal which is digitized and used to calculate blood pressure parameters. The sensor measures the pulse at the point of maximum energy transfer; the wave shapes are analyzed by Medwave's proprietary algorithms. Parameters are extracted from the waveforms and a set of coefficients are applied to them yielding systolic, mean, and diastolic pressures approximately every 15 heart beats. These algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms. Patient pressures can be monitored visually by viewing the screen and audibly entering limits into the Fusion™ System alarm menu. Patient measurements above or below the limits will be automatically brought to the attention of the caregiver through these visual and audible alarms. A Start/Stop key provides the operator with an option to cancel operation at anytime. The Fusion™ System can be ordered with additional module options: - · Tyco Healthcare Nellcor OxiMax Pulse Oximetry System (K012891) provides monitoring of a patient's functional oxygen saturation of arterial hemoglobin. - · Kendall Genius Thermometer (K920713) provides patient's body temperature readings. - · Seiko Thermal Printer SII providing hardcopy of readings selected to print.

The Primo™ Noninvasive Blood Pressure Measurement System is a hand held non-invasive blood pressure measurement system intended to be used on adult patients with wrist circumferences of 11 cm - 22 cm by trained medical personnel to measure systolic, diastolic blood pressure and pulse rate.

The Primo™ Noninvasive Blood Pressure Measurement System is a hand-held non-invasive blood pressure measurement system that measure systolic, diastolic blood pressure and pulse rate from the user's wrist. The system is contained in hard plastic housings that contain a user interface panel and a wrist sensor. The characteristics of the arterial waveforms are recorded with a unique pressure sensor that is placed over the radial artery. This system provides a single reading of blood pressure, using a pressure sensor placed on the wrist over the radial artery. This sensor is noninvasive.