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The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear and iron sucrose infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The predicate device includes a Patient Monitor, a Fiber Optic Sensor Cable, and a disposable Sensor Receptacle. Under K192385 the system was expanded to add three Device Accessories including an Extension Module, a Patient Cable and SmartTouch Sensor. The Device Accessories expand system's functionality to support two sensor technologies (fiber optic and electronic). The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The ivWatch Patient Monitor (IPM) contains an optical system that generates visible and near-infrared light signals that are sent through the sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations, but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use Sensor Receptacle. The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The predicate device (K162478), the ivWatch® Model 400, consists of the ivWatch® Patient Monitor, a reusable Fiber Optic Sensor Cable and a single-use sterile Sensor Receptacle. The subject device includes the addition of Device Accessories to the ivWatch® Model 400 including an Extension Module, reusable Patient Cable and a single-use electronic SmartTouch™ Sensor. The Device Accessories expand the current ivWatch® Model 400 architecture to support the reusable Fiber Optic Sensor (predicate device) and an electronic single-use sterile SmartTouch™ Sensor (subject device). Both the predicate and subject device provide continuous, non-invasive monitoring of human tissue adjacent to peripheralintravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch® Model 400 with Device Accessories uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. Light signals generated by the SmartTouch™ Sensor are sent to the patient's tissue near an PIV site. Changes to the light signals are received by the SmartTouch™ Sensor and electrical signals are transferred through the Patient Cable to the Extension Module where embedded software analyzes the data to determine whether conditions indicate that an infiltration event may have occurred. The information is then sent from the Extension Module to the ivWatch® Patient Monitor for display. If changes in the diffuse reflectance in the tissue near the PIV site are consistent with an infusate pooling in the subcutaneous tissue, the ivWatch® Patient Monitor emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

The ivWatch Model 400 is a medical device that provides continuous, non-invasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use sensor receptacle. The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signals are processed by the ivWatch signal processing algorithm to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the PIV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the PIV site for a possible infiltration event.

The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The iv Watch Model 400 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the iv Watch Model 400.

The ivWatch Model 400 is a medical device that provides continuous, noninvasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites on the forearm and dorsal aspect of the hand to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable and a single-use sensor receptacle. The ivWatch Model 400 uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site. The IPM contains an optical system that generates visible and near-infrared light signals that are sent through the optical sensor cable to the patient's skin. Simultaneously, the IPM measures the light reflected back through the optical sensor cable from the patient's skin. Measured changes between the emitted and reflected signal are processed by proprietary ivWatch signal processing algorithms to determine if an infiltration event may have occurred. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.

The iv Watch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by physicians, or under the direction of a physician, who have been trained in the use of the iv Watch Model 400.

The ivWatch Model 400 is a medical device that provides continuous, noninvasive monitoring of human tissue adjacent to peripheral intravenous (PIV) insertion sites on the forearm and dorsal aspect of the hand to aid in the early detection of infiltration and extravasation events. The ivWatch Model 400 ("Device") consists of the ivWatch Patient Monitor (IPM), a reusable optical sensor cable, and a single-use sensor receptacle. The device uses visible and near-infrared light to measure changes in the optical properties of the tissue near a PIV insertion site; the measured changes are processed by proprietary ivWatch signal processing algorithms to determine if an infiltration event may have occurred. The device is indicated for use by medical professionals who are experienced with administering or monitoring peripheral IV therapy. The IPM mounts to an IV pole, typically above the infusion pump. The sensor is secured in the receptacle and subsequently placed on the patient's skin near the peripheral IV insertion site for the duration of the IV monitoring. The fiberoptic sensor cable follows the IV line back to the pole-mounted IPM. One end of the sensor cable attaches to the IPM; the other end snaps into the ivWatch sensor receptacle, which secures the sensor to the patient's skin. The sensor cable is a multiple-use disposable with a total useful life of approximately 240 hours of IV monitoring; it is intended to be cleaned between uses. The ivWatch sensor receptacle is molded out of biocompatible plastics and includes biocompatible adhesives for attaching the receptacle to the patient's skin. The sensor receptacle is a single-use disposable and supplied sterile. The IPM contains an optical system that generates light signals that are sent to the patient's skin (via the sensor cable) and measures the light returning from the patient's skin (also via the sensor cable). The Device uses low power LEDs as sources of visible and near-infrared (NIR) light. Optical fibers in the sensor cable deliver the light from the IPM to the sensor and transmit reflected light back to the IPM. The IPM also contains the hardware for executing the proprietary ivWatch signal processing algorithm. If changes in the optical properties of the tissue near the peripheral IV insertion site are consistent with an infusate pooling in the subcutaneous tissue, the IPM emits audible and visual notifications intended to prompt the clinician to inspect the peripheral IV site for a possible infiltration event.