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The DINAMAP MPS* Select* Portable Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device (K955113) and include connection to the OBSERVER* Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP* Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NiMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use.

The DINAMAP MPS Portable Monitor is a prescription device intended for use only by health care professionals. It can be used in hospital and/or outpatient surgery center settings and functions as a portable and/or transport multiparameter monitoring unit. It is designed for monitoring adult, pediatric and neonatal patients in acute care settings such as critical care, emergency room, radiology, labor and delivery, operating room, and same-day surgery. Using this monitor, the clinician can view, record and recall clinical data derived from the user-selectable monitoring parameter modules. This clinical data includes heart rate, ECG waveforms, oxygen saturation (SpO2), invasive pressure, noninvasive pressure (systolic, diastolic, mean), endtidal carbon dioxide (CO2), respiration rate and temperature. These are the same modules utilized in the currently-marketed Johnson & Johnson Medical, Inc. (JJMI) DINAMAP MPS* Select* Monitor which received marketing clearance August 15, 1996, via 510(k) premarket notification K955113: • ECG (3 lead)/Respiration/Heart Rate/Continuous Temperature • ECG (6 lead)/Respiration/Heart Rate/Continuous Temperature • Noninvasive Blood Pressure/Heart Rate • Invasive Pressure/Heart Rate • Pulse Oximetry (Oxygen Saturation)/Heart Rate • Endtidal Carbon Dioxide/Respiration • Recorder (double wide) The Portable Monitor accepts modules in any combination and the waveforms and parameter measurements on the screen vary according to the modules that are in the Monitor. The Monitor will detect module type and will disable modules as appropriate (e.g. duplicates) to prevent the system from operating improperly. Modules can be inserted or removed, as necessary, while the Monitor is operating. When a module is inserted, the Monitor automatically detects it. When a module is removed, the patient can continue to be monitored with any of the remaining modules. The Portable Monitor is self-contained and has a carrying handle. It can be operated from internal battery or AC (via an in-line DC power supply). At the side of the Monitor are six slots for modules. All patient connectors are on the modules. On the front of the Monitor are three indicators that let the user know when the backup battery is being charged or if the Monitor is operating on AC or battery power. The internal battery is capable of powering the Portable Monitor for 60 minutes (+ 10 minutes). The two optional user-replaceable batteries are capable of adding 60 minutes each to the operating time. On the back of the monitor are the on/off button, power supply connection, optional user-replaceable Nickel Metal Hydride (NiMH) batteries, network and device connections, and an optional pullout hanging bracket. On the bottom of the Monitor is the mounting plate. The Portable Monitor provides connections for the currently-marketed JJMI OBSERVER* Central Station (K933404; hardwire, digital spread spectrum or VHF communication); other monitoring devices, such as the currently-marketed JJMI DINAMAP PLUS Monitors (K943709 & K912188); a remote monitor (display); a full-page printer; data collection or hospital information system; remote alarm and/or Ethernet network. If the Portable is networked, the user may observe vital signs data from other devices by using the Remote View feature. As with the monitoring parameter modules, communications protocols for the Portable Monitor are the same as the currently-marketed DINAMAP MPS* Select* Monitor.

The provided text describes a 510(k) submission for the DINAMAP MPS Portable Monitor. This document does not contain acceptance criteria or a study proving that a device meets acceptance criteria, as it is a premarket notification for a vital signs monitor, not a diagnostic AI device.

The document primarily focuses on establishing substantial equivalence to a predicate device (DINAMAP MPS Select Monitor), device description, classification, and indications for use. It mentions that "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP MPS Portable Monitor: • Environmental • Electromagnetic Compatibility • Battery Life". However, it does not provide details of these studies, nor does it list specific acceptance criteria or performance metrics.

Therefore, I cannot provide the requested information for acceptance criteria and study details based on the provided text.

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