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Intended Use:

The devices are intended to be used for monitoring and recording of, and to generate alarms for multiple physiological parameters of adults, pediatrics, and neonates.

Indications for Use:

• The devices are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
• The monitors are only for use on one patient at a time.
• The monitors are not therapeutic devices.
• Caution: The monitors are for prescription use only.
• The ECG measurement is indicated to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11).
• ST segment monitoring is indicated for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients.
• BIS is indicated for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is indicated for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
• The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is indicated for use with adult patients only.
• The derived measurement Pulse Pressure Variation (PPV) is indicated for use with sedated patients receiving controlled mechanical ventilation and mainly free from cardiac arrhythmia. The PPV measurement has been validated only for adult patients.
• The IntelliVue NMT is indicated to be used as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve. The NMT Module is indicated to be used with adult and pediatric patients.
• The Masimo rainbow SET measurement is indicated for the noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRac). The Masimo rainbow SET measurement is indicated for use during both no motion and motion conditions, and for patients who are well or poorly perfused.
• The noninvasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics >5 kg and <40 kg in healthcare environments.
• The Sedline Sedation Monitor is indicated to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents. The agents include: Alfentanil, Desflurane, Fentanyl, Isoflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedline Sedation Monitor is indicated for use with adult patients (18 years of age and older) in the operating room (OR), intensive care unit (ICU), and clinical research laboratory.
• The Predictive Temperature module is indicated to provide an accurate prediction of patient temperature using the oral, axillary, or rectal body sites, or to provide an actual temperature reading in the continuous monitor mode to adult and pediatric patients.
• The NanoPod capnography module is indicated to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is indicated for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, intra-hospital transport.
• The NanoPod capnography module provides the clinician with an integrated pulmonary index (IPI). The IPI is based on end tidal carbon dioxide, respiration rate, oxygen saturation and heart rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status. The Integrated Pulmonary Index (IPI) is indicated for use with adult and pediatric (1 to 12 years) patients only.

The IntelliVue Measurement Rack 6000 (MR6000) is a hardware component designed with four slots that allow connection to the existing IntelliVue Plug-in Measurement Modules. The MR6000 establishes communication between the already cleared individual Plug-in Measurement Modules and the IntelliVue Patient Monitors 6100, 6300 and 6500.

The MR6000 enables the IntelliVue Patient Monitors (PM6100, PM6300 and PM6500) to scale up measurement capabilities, as it serves as an interface between the Patient Monitors and the currently distributed IntelliVue Plug-in Measurement Modules.

The MR6000 is connected to the IntelliVue Patient Monitor models 6100, 6300, 6500 via the measurement link cable (MLink).

The MR6000 has its own power supply with its own mains connection.

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