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The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The monitors are additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended 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 Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The subject devices Intelli Vue Patient Monitors MX400, MX450, MX500, and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The specific models differ in the size of their flat panel displays and in the number of supported external measurement modules. MX400 has a 9" display, MX450 and MX500 have a 12" display and MX550 has a 15" display. In addition to the MX400 and MX450, the MX500 and MX550 models have three integrated slots for use with the dedicated external plug-in modules. The monitors do not have any built-in measurements. They are intended to be connected to any one of the external IntelliVue family physiological multi-measurement modules and/or (MX500/MX550 only) to the IntelliVue plug-in measurement modules. The monitors support multiple non-invasive and invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, invasive and noninvasive blood pressure, temperature, CO2, C.O., CCO, intravascular SO2, spirometry, EEG, gas measurements, and NMT. The interaction with the patient depends on the monitored physiological parameter(s). The monitors acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The monitors offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity at the bedside. The monitors can also be used mobile, during patient transport in a hospital setting. The measurement sensors of the connected external measurement modules are applied at diverse bodily locations, depending on the actual physiological parameters monitored, e.g. on a patient's finger for the pulse oximetry or on a patient's upper arm for the non-invasive blood pressure. The monitors have a color display with touch-screen as a primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. One external display, which provides an adaptive duplicate image of the primary display, can be connected to a built-in video port. The monitors interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or wireless link. The modification, which is subject of this Premarket Notification, enables the IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 via software update to support two additional features: Remote Display application and Remote Applications, The Remote Display application feature provides the possibility to view an independent monitor screen on an external display and to operate patient monitor from the external display. The Remote Applications feature allows the user of the patient monitor to access remotely hosted, pre-configured applications made available by the hospital. The added functionalities are the same as those already provided by other legally marketed Philips IntelliVue Patient Monitors, such as predicate model MX800. For access to the Remote Applications, the predicate Intelli Vue Patient Monitor MX800 supports commercial application server technology, whereas the modified IntelliVue Patient Monitors MX400, MX450, MX500, and MX550 support commercial application server technology as well as the HTML5 protocol for compatibility with standard web application servers

The IntelliVue CL Respiration Pod is indicated for use by health care professionals whenever there is a need for intermittent or spot-check acquisition and monitoring of physiological patient parameters respiration rate and pulse rate wirelessly in specific hospital areas. The IntelliVue CL Respiration Pod is mainly indicated for use in general medical and surgery wards and in waiting areas of emergency rooms. It is not indicated for use in hospital areas in which continuous patient monitoring is needed, such as intensive care units or operating rooms. The intended use of the IntelliVue CL Respiration Pod when used together with a patient monitor is for intermittent or spot-check monitoring and recording of, and to generate alarms for, respiration rate and pulse rate of adult patients. The IntelliVue CL Respiration Pod is also intended for acquisition of respiration rate and pulse rate data of adult patients for a clinical information management system. The IntelliVue CL Respiration Pod is intended for use by health care professionals. It is not intended for home use. It is not a therapeutic device. The IntelliVue CL Respiration Pod is not intended for use on patients with extremely high values for respiration rate (above 60 rpm). The IntelliVue CL Respiration Pod is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias, e.g. very fast atrial fibrillation or ventricular tachycardia (rapid irregular pulse rate). For monitoring of these patients, a device for continuous ECG monitoring is necessary. The IntelliVue CL Respiration Pod is not a substitute for an ECG monitor. Warning: Do not use the CL Respiration Pod on patients with rapid, irregular heart rates greater than 110 bpm. Use under these conditions has not been clinically validated. Rx only: US Federal Law restricts these devices to sale by or on the order of a physician.

The IntelliVue CL Respiration Pod is a small body-worn, cableless, battery powered, respiration rate and pulse rate measuring and monitoring device. It uses specifically designed adhesive attachment (Mobile CL Resp Attachment, cleared with K122223), which holds the CL Respiration Pod at the patient chest. The CL Respiration Pod provides and communicates measurements values and other information (e.g. battery state) wirelessly via Short Range Radio (SRR) to an assigned compatible IntelliVue Patient Monitor or IntelliVue GuardianSoftware. It can also provide information on basic posture (like supine, prone, upright etc.) and activity of the patient. The CL Respiration Pod can be controlled from the assigned IntelliVue Patient Monitor or IntelliVue GuardianSoftware. The CL Respiration Pod is a small, battery powered, wireless, and body worn respiration and pulse rate measuring and monitoring device. It is attached to the patient's left costal arch using a specialized accessory, the adhesive Mobile CL Resp Attachment. The CL Respiration Pod has a multicolor LED and a single key to display states and allow basic operation locally. The CL Respiration Pod is connected during its use wirelessly via SRR a compatible IntelliVue Patient Monitor or IntelliVue to GuardianSoftware. The CL Respiration Pod uses a measurement principle that is based the thoracic movements. Inclination changes of the on incorporated accelerometer sensor, caused by chest and abdomen movements during breathing and heart contraction, produce a voltage signal, from which respiration and pulse rate signals are derived. The modified Philips IntelliVue CL Respiration Pod uses the same measurement principle (respiratory effort and heart contraction/beating) to derive the respiration and pulse signal as the predicate Philips IntelliVue CL Respiration Pod. With the means of the built-in accelerometer sensor, the modified CL Respiration Pod also detects activity and basic posture of the patient. This is the same technology as used by the legally marketed Philips IntelliVue CL Respiration Pod (K122223).

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The monitors are additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI I). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended 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 Protocol Watch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (I to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended 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 Module is intended to be used as an objective neuromuscular transmission monitor, using accelerometry for measuring the muscle contraction following an electrical stimulation of a peripheral nerve. The NMT Module is intended to be used with adult and pediatric patients.

The IntelliVue Patient Monitors MX500 and MX550 are modification of the legally marketed IntelliVue Patient Monitor MP50. The MX500 and MX550 are display units with a TFT LCD flat panel display and built-in CPU. The models MX500 and MX550 differ only in the size of their flat panel displays: MX500 has a 12" and MX550 has a 15" display. The MX500 and MX550 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module, any one of the M3012A. M3015A/B or M3016A Measurement Server Extensions. plug-in measurement modules M1006B Invasive Blood Pressure, M1011A Intravascular SQ2, M1012A C.O. /CCO, M1014A Spirometry, M1020B SpQ2, M1027A EEG, M1029A Temperature, 865383 NMT, 865115 IntelliBridge EC10, to the 865298 (TcG10) Transcutaneous Gas Module and to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO, Intravascular SO2, Spirometry, EEG and NMT. The MX500 and MX550 acquire multiple physiological patient signals (via connected external measurement modules). display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The MX500 and MX550 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital. The MX500 and MX550 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. The MX500 and MX550 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN or WLAN.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The MP5 and MP5SC monitors are also intended for use during patient transport inside the hospital environment; only the MP5 monitor is for use during patient transport outside of the hospital environment. The MP5 and MP5SC when used with the TRx4841A/TRx4851A IntelliVue Telemetry System Transceiver or with the IntelliVue Cableless Measurement Devices, are intended for use in a hospital environment and during patient transport inside the hospital environment. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature measurement is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the Protocol Watch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended 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 Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models: IntelliVue Patient Monitors MP5 and MP5SC, that consist of display units including built-in and central processing units (CPU) and physiological measurements. All monitors share the same system architecture and exactly the same software is executed on each monitor. The IntelliVue Patient Monitors measure multiple physiological parameters such as surface ECG, invasive and non-invasive etc., generate alarms, record physiological pressure, signals, store derived data, and communicate derived data and alarms to central stations via the IntelliVue Clinical Network. The subject modification introduces the optional The Philips Tympanic Temperature Module (866149) for the IntelliVue Patient Monitors MP5 and MP5SC. This Tympanic Temperature extends the capability of the IntelliVue Patient Module Monitors MP5 and MP5SC to interface the Genius™ 2 Tympanic Temperature Probe (cleared by Covidien, K060649). Additionally the software revision J.21 is made available for the IntelliVue Patient Monitors MP5 and MP5SC.

The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates. The monitors are intended for use by trained healthcare professionals in a hospital environment. The monitors are additionally intended for use in transport situations within hospital environments. The monitors are only for use on one patient at a time. They are not intended for home use. Not therapeutic devices. The monitors are for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI ECI1). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring. The derived measurement Pulse Pressure Variation (PPV) is intended 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 Patient Monitor MX400 and MX450 is a modification of the legally marketed IntelliVue Patient Monitor MP30. The MX400 and MX450 are display units with a TFT LCD flat panel display and built-in CPU. The models MX400 and MX450 differ only in the size of their flat panel displays: MX400 has a 9" and MX450 has a 12" display. The MX400 and MX450 do not have any built-in measurements. They can be connected to one Philips M3001A Multi-Measurement Server, M3002A (X2) Multi-Measurement Module and any one of the M3012A, M3014A, M3015A/B or M3016A Measurement Server Extensions, as well as to the M1013A (G1) or M1019A (G5) Gas Modules. These external devices provide non-invasive and invasive measurements such as ECG with arrhythmia and ST, respiration, SpO2, NBP, invasive blood pressure, temperature, CO2, C.O., CCO. The MX400 and MX450 acquire multiple physiological patient signals (via connected external measurement modules), display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. The MX400 and MX450 offer a monitoring solution optimized for the surgical, cardiac, medical and neonatal care environments. They are located in the patient vicinity either at the bedside or used mobile, during patient transport in the hospital. The MX400 and MX450 have a color display with touch-screen as primary input device. They also support a specialized remote control, keyboard and pointing devices such as a mouse. The MX400 and MX450 interact with the connected external measurement devices locally at the bedside or in transport situations and with the Central Station via LAN.

The monitor is indicated for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The monitor is intended to be used for monitoring and recording of, and to generate alarms, for, multiple physiological parameters of adults, pediatrics, and neonates. The monitor is intended for use by trained healthcare professionals in a hospital environment. The monitor is also intended for use during patient transport inside and outside of the hospital environment. The monitor is only for use on one patient at a time. It is not intended for home use. Not a therapeutic device. The monitor is for prescription use only. The ECG measurement is intended to be used for diagnostic recording of rhythm and detailed morphology of complex cardiac complexes (according to AAMI EC 11). ST segment monitoring is intended for use with adult patients only and is not clinically validated for use with neonatal and pediatric patients. The Predictive Temperature unit is intended for use with adult and pediatric patients in a hospital environment. The SSC Sepsis Protocol, in the ProtocolWatch clinical decision support tool, is intended for use with adult patients only. The derived measurement Pulse Pressure Variation (PPV) is intended 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 transcutaneous gas measurement (tcGas) is restricted to neonatal patients only. BIS is intended for use under the direct supervision of a licensed health care practitioner or by personnel trained in its proper use. It is intended 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 Philips IntelliVue Patient Monitors family comprises the multiparameter patient monitor series: MP2, X2, MP5, MP5T, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 and MX600, MX700, and MX800. Each monitor consists of a display unit including built-in or separate central processing unit (CPU) and physiological measurement modules. All monitors share the same architecture of CPU units and exactly the same software is executed on each monitor. The monitors measure physiological parameters such as: Sp02, pulse, ECG, arrhythmia, ST, QT, respiration, invasive and noninvasive blood pressure, temperature, CO2, spirometry, C.O., CCO, tcp02/ tcpCO2, S02, Sv02, Scv02, EEG, and BIS. They generate alarms, record physiological signals, store derived data, and communicate derived data and alarms to the central station. IntelliVue series MP2, X2, MP5, MP5T, MP5SC, MP20, and MP30 are robust, portable, lightweight, compact in size and modular in design patient monitors with interfaces to dedicated external measurement devices. Models MP2, X2, MP5, MP5T, and MP5SC also incorporate multiple built-in physiological measurements. IntelliVue series MP40, MP50, MP60, MP70, MX600, MX700, and MX800 are patient monitors with built-in central processing unit, flat panel display and interfaces to dedicated external measurement devices. Models MX600, MX700, and MX800 have widescreen displays. IntelliVue series MP80 and MP90 are patient monitors with flat panel display and central processing unit as separate components. They have interfaces to dedicated external measurement devices.

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of and to generate alarms for multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, MP5, MP5T, MP5SC, X2, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments. The MP2, X2 and MP5 are also intended for use during patient transport outside of a hospital environment. The Integrated Pulmonary Index (IPI) is intended for use with adult and pediatric (1 to 12 years) patients only. The IPI is an adjunct to and not intended to replace vital sign monitoring.

The Philips IntelliVue Patient Monitor family comprises the multi-parameter patient monitor models MP2, X2, MP5, MP5SC, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, MX600, MX700 and MX800 Patient Monitors which consist of display units IntelliVue including build-in or separate flat panel displays and central processing units as well as physiological measurement modules. All monitors share the same system architecture and exactly the same software is executed on each. The Patient Monitor family is a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions to the IntelliVue family plug-in measurement modules. The and monitors can also be connected to the IntelliVue anesthetic gas modules and to the IntelliVue TcG10 Measurement Module. The subject modification is the introduction of the Integrated Pulmonary Index (IPI) software module as an extension to the legally marketed Microstream CO2 measurement module as integrated or interfaced to the Patient Monitor family. The IPI is a numerical integer value ranging from 1 to 10. It is calculated based on the four major parameters from the monitoring of the physiological parameters CO2 and SpO2 in order to provide a simple and clear single parameter indication of the patient's ventilation status. These four major parameters are etCO2 and Respiration Rate (RR) which are received from the Microstream CO2 measurement module, as well as SpO2 and Pulse Rate (PR) which are received from the pulse oximetry module of the host system.

IntelliVue Guardian Software: The IntelliVue Guardian Software is indicated for use by healthcare providers whenever there is a need for generation of a patient record. The IntelliVue Guardian Software is intended for use in the collection, storage and management of data from IntelliVue Cableless Measurements and IntelliVue Patient Monitors that are connected through networks. IntelliVue CL SpO2 Pod: The IntelliVue CL SpO2 Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters Sp02 and pulse rate wirelessly. The intended use of the IntelliVue CL SpO2 Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of arterial oxygen saturation and pulse rate of adult and pediatric patients. The IntelliVue CL SpO2 Pod is also intended for acquisition of arterial oxyger saturation and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL SpO2 Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device. IntelliVue CL NBP Pod: The IntelliVue CL NBP Pod is indicated for use by health care professionals whenever there is a need for acquisition or monitoring of physiological patient parameters non-invasive blood pressure and pulse rate wirelessly. The intended use of the IntelliVue CL NBP Pod when used together with a patient monitor or with a telemetry system transceiver is for monitoring, recording, and alarming of systolic, diastvlir, and mean pressure and pulse rate of adult and pediatric, patients. The IntelliVue CL NBP Pod is also intended for acquisition of systolic, diastolic, and mean pressure and pulse rate data of adult and pediatric patients for a clinical information management system. The IntelliVue CL NBP Pod is intended for use by health care professionals inside hospitals. It is not intended for home use. It is not a therapeutic device.

New IntelliVue Guardian Software: The new IntelliVue Guardian Software is a Clinical Information Management System. It collects and manages vital signs data acquired from the IntelliVue Cableless Measurements and IntelliVue patient monitors. The Guardian Software provides trending, review, reporting, notification, clinical documentation, calculations, clinical advisories including EWS deterioration status, remote viewing and operating, interfacing, storage, and printing. The IntelliVue Guardian Software is software only product intended to be installed on a customer supplied PC or Server. Modified IntelliVue CL SpO2 Pod: The IntelliVue CL SpO2 Pod is a small, battery powered, wrist worn pulse oximeter device. It contains Philips FAST-Sp02 (Fourier Artifact Suppression Technology) to provide reliable saturation values under various artifact conditions including motion and low perfusion. It provides continuous cperating mode and intermittent operating mode with configurable measuring me intervals. Integrated monochrome LCD display shows measured values, measurement signal quality, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable SpO2 sensors. The IntelliVue CL Sp02 Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is solely limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software. Modified IntelliVue CL NBP Pod: The IntelliVue CL NBP Pod is a small, battery powered, noninvasive blood pressure and pulse rate measurement device. It uses oscillometric method for measuring NBP. It produces numerics for systolic, diastolic and mean blood pressure values and pulse rate. Integrated monochrome LCD Display shows measured values, battery state, and RF signal strength. It has three hardkeys for basic operation and navigation. It supports specialized Philips reusable and disposable NBP cuffs. The IntelliVue CL NBP Pod remains unchanged as it is. The modification, which is subject of this Premarket Notification, is limited to the labeling change in order to indicate the usage of this device together with the new Philips IntelliVue Guardian Software.

IntelliVue MP40, MP50, MP60, MP70, MP80, MP90 and MX800 and IntelliBridge EC10 and EC5 IC Module: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. IntelliVue TcG10 Measurement Module: Indicated for use by health care professionals whenever there is a need to support the continuous and noninvasive monitoring of transcutaneous partial pressures of blood gas carbon dioxide and oxygen of patients not under gas anesthesia.

The modified Philips MP40, MP50, MP70, MP80, MP90, and MX800 IntelliVue Patient Monitors are a flexible and modular monitoring solution optimized for the surgical, cardiac, general medical and neonatal care environments. The monitors can be connected to the Philips Multi-Measurement Module (MMS) family with its extensions and to the IntelliVue family plug-in measurement modules. The monitors can also be connected to the IntelliVue anesthetic gas modules and to the new Intellivue TcG10 Measurement Module. The modified Philips IntelliBridge EC10 and EC5 ID modules build an external medical device solution to collect data from external devices at the bedside providing the data to patient monitors, and patient monitoring networks. The modified EC10 and EC5 ID modules support the interface of the IntelliVue patient monitors with the new IntellVue TcG10 Measurement Module. The new IntellVue TcG10 Measurement Module is a device for the continuous and noninvasive measurement of the transcutaneous partial pressures of blood gas carbon dioxide (pCO2) and oxygen (p02) of patients from all pediatric subgroups and of adult patients not under gas anesthesia in hospital environment. The transcutaneous measurement of pCO2 and pO2 makes use of the fact that carbon dioxide and oxygen gases are able to diffuse through body tissue and skin and can be detected by a sensor placed at the skin surface. By warming up this sensor, a local hyperemia is induced, which increases the supply of arterial blood to the dermal capillary bed below the sensor. The transcutaneous blood gas values (tcpCO2 and tcpO2) have to be interpreted primarily as the blood gas partial pressures prevailing at the level of the arterialized skin tissue. In general, this value correlates well with the corresponding arterial blood gas partial pressure.

Avalon Fetal/Maternal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms, in antepartum testing areas, in private households and during transports in healthcare facilities. Avalon Fetal/Maternal Monitor FM40: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas. Avalon Fetal/Maternal Monitor FM50: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.

The legally marketed Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40, and FM50 offer monitoring of fetal and maternal heart rates, uterine activity, maternal ECG wave, maternal non-invasive blood pressure (NIBP) and oxygen saturation (SpO2) with pulse rate, during antepartum testing and labor and delivery. The Avalon Fetal/Maternal Monitor FM20 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal pulse rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2). The Avalon Fetal/Maternal Monitor FM30 shares all the features and capabilities of the Avalon FM20. In addition, the Avalon FM30 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored. The Avalon Fetal/Maternal Monitor FM40 provides the following external measurement parameters: Up to three Fetal Heart Rates (FHR) via ultrasound (US), Fetal Movement Profile, Uterine activity via external Toco, Maternal Pulse Rate, Maternal Heart Rate via maternal ECG, Non-invasive blood pressure (NIBP), Pulse oximetry (maternal SpO2). The Avalon Fetal/Maternal Monitor FM50 shares all the features and capabilities of the Avalon FM40. In addition, the Avalon FM50 provides the following external and internal measurement parameters: One Fetal Heart Rate and one fetal DECG wave via direct ECG (DECG), Uterine activity via intrauterine pressure (IUP), Maternal ECG (MECG) wave. Note: maximum three fetal heart rates can be monitored. Device Modifications: Operation of the models FM20 (M2702A) and FM30 (M2703A) with an internal rechargeable power source (optional) to support fetal/maternal monitoring during transport within healthcare facilities. Modification of the existing Toco transducer M2734A to include maternal pulse measurement, using plethysmography at an alternative body location (abdomen). The modified transducer is labeled M2734B 'Toco MP'. Automated antepartum fetal/maternal trace interpretation and printout the resulting non-stress test (NST) report. The new software G.02.xx, which is a modification of the software F.01.xx (cleared with K102958) to support the before listed modifications / additions. Additionally, the option to equip the Avalon Fetal/Maternal Monitors with maternal SpO2 measurement is enabled now also for the model FM20 (M2702A).