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The DSPM-70 Blood Pressure Measurement System is suitable for measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used for management of intraoperative and post-surgical critically ill patients. The information measured is suitable for use in derivation of blood pressure parameters such as heart rate, systolic pressure, diastolic pressure, and mean pressure, Not to be used where there is the potential for accidental entry of the catheter into the heart or other site in the body where patient safety may be compromised. The transmitter portion of the product is intended to be secured to the skin with tape with the distal tip of the pressure sensing catheter placed in the vasculature at a physician specified site. The system is intended to be limited to use in a single patient for less than 7 days. The external equipment may be reused. While the DSPM-70 is indicated for 7 days use, research has shown that in some patient populations, risk of infection increases when indwelling catheters remain in use for longer than 72 hours. Duration of use should be determined by institutional guidelines and consideration of various sources of risk to the patient. The DSPM-70 has no feature that provides the ability to draw blood from the patient. [ 4 French models: ] Intended for use on critically ill intra-operative and postsurgical patients at sites suitable for insertion of a 4 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.061 inches such as the Terumo Medical model SR-OX1451CA 14 Ga x 2 inch Surflo I.V. Catheter. Introducer sheath should remain in place after insertion. Not intended for neonatal use. [2 French models:] Intended for use on critically ill intra-opcrative and postsurgical patients at sites suitable for insertion of a 2 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.034 inches such as the Terumo Medical model SR-OX1832CA 18 Ga x 1 1/4 inch Surflo I.V. Catheter. Introducer sheath should remain in place after inscrtion. Neonatal applications are limited to femoral artery use only.

The DSI Blood Pressure Measurement System (DSPM-70) consists of the following components: 1. Pressure Transmitter with Catheter 2. External Data Receiver 3. Analog Adapter 4. Ambient Pressure Reference 5. External Power Supply 6. Signal Detector 7. Replacement Gcl. The pressure transmitter is a small anatomically disc-shaped device that houses the power source (battery), circuitry, RF coil and pressure sensing diaphragm. The transmitter device is intended to be placed during surgery on the chest and secured with tape. It is a short duration non-permanent product. A small diameter catheter is integrated with the transmitter and functions as the pressure conduit between the blood stream and the device. This catheter is filled with a fluid and the distal tip is sealed with a biocompatible gel. The gel transmits the pressure of the blood to the internal catheter fluid which, in turn, transmits the pressure to the device. The External Data receiver contains a specific RF antennae which receives the signals from the transmitter. The data from the device is received and recorded for physician use. The external receiver does not process the data or make any data calculations. The external unit is powered by the Power Supply. The Analog Adapter is an interface between the single channel transmitter and external analog recording instruments. The Analog Adapter along with the Ambient Pressure Reference discussed below, provide a calibrated analog signal allowing easy connection to most computerized data acquisition systems or strip chart recorders. The Ambient Pressure Reference component of the system provides continuous measurement of ambient barometric pressure. Continuous patient blood pressure is the difference between the pressure measured by the device and the ambient barometric pressure in the room. The power supply is a 110 VAC adapter that plugs into a standard outlet and connects to the receiver. The power supply is rated at 110 VAC and 60 Hz. It has been designed to meet UL and CSA requirements. The signal detector is a device that can be used by the physician as a tool to determine if the device is operating or in standby mode. The transmitter operates at a specific frequency range that is detected by the signal detector. If the signal is detected, the signal detector emits an audible tone.