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Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

The Telemetry Monitor 5500 is a battery-operated patient worn monitor with a touchscreen display. The Telemetry Monitor 5500 is intended to monitor and record, and to generate alarms for, multiple physiological parameters like ECG, SpO2, and respiration rate. It is equipped with a 1.4 GHz radio to enable wireless bi-directional data flow with Philips' Patient Information Center (PIC) iX.

The Philips Holter Analysis System provides measurements, data, and reporting of parameters such as normal sinus rhythm, arrhythmias, QT and ST measurements, paced beats analysis and HRV, that can be used by a qualified clinician for the evaluation of: - Symptoms that may be related to rhythm disturbances of the heart in adult patients. - Risk in patients with or without symptoms of arrhythmia. QT measurement information is provided to support this assessment by a competent health professional. - Efficacy of antiarrhythmic therapy - Pacemaker function - Symptoms that may be associated with myocardial ischemia The Philips Holter Analysis System is not intended for use for pediatric patients. The EASI derived 12-lead ST measurements are not recommended unless patients meet the following parameters: - Age: Between 33 to 82 years - Height: Between 147 to 185 cm (58 to 73 inches) - Weight: Between 53 to 118 kg (117 to 261 lbs) - Height to Weight Ratio: Between 1.41 to 2.99 cm/kg (0.25 to 0.54 in/lb) If patients do not meet these parameters, the EASI derived 12-lead ST measurements are not intended for use. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations.

The Philips Holter Analysis System (hereinafter known as Philips HAS) is offered as standalone software. It is intended to be installed into a user's PC (general purpose computing platform). The product evaluates the heart rhythms of ambulatory ECG data over an extended period and generates a preliminary analysis for physician's review. The ECG data is downloaded from compatible ambulatory ECG recorders. It is to be used by trained personnel. The Philips Holter Analysis System accepts ECG recordings from DigiTrak XT recorders (K071733) and analyzes the patient's heart activity for the recorded period, typically from 24 hours up to 7 days. The analysis is not performed in real time. The DigiTrak XT recorder collects up to 168 hours (7 days) of ambulatory ECG. The software can analyze up to 168 hours (7 days) of contiguous ECG data. The algorithm (Zymed Algorithm, also internally referred to as the CAlg-Holter Algorithm) used in Holter Analysis System was first developed and approved for use in the Holter Scanner Model 1210. It was continually updated and subsequently cleared for use in more Holter Models. It includes Heart Rate Variability (Time Domain) as a standard software report configuration in March 1996. The operating system converted from a DOS operating system to a Windows operating system in April 1999. Heart Rate Variability Frequency Domain was added in February 2001. The QT analysis was added in September 2001. The most recent 510(k) including above features and functions is under K010949. The Zymed Algorithm in the HAS incorporates the following enhancements in the subject device: - Upgraded AFIB detection by replacing the current algorithm with the Philips ST/AR AFIB algorithm's P wave detection feature. The feature was cleared in K101521 with Philips ST/AR ST and Arrhythmia Software. - Enhanced HRV reporting by replacing current calculations with advanced data warehouse calculations from PhysioNet. Incorporated Nonlinear HRV to provide more characterization of heart rate variability that linear methods could miss. - Incorporated bug fix, and code security - Upgraded compiler The EASI derived 12-lead display function was cleared in K020456. It remains unchanged in the subject device. Philips does not incorporate any additional usage in the subject device beyond these clearances. The EASI 12-lead is only for display purposes, allowing end users to visualize EASI lead ECG recordings in a traditional 12-lead format. EASI derived 12-Lead ECGs and their measurements are approximations to conventional 12-Lead ECGs and should not be used for diagnostic interpretations. No automatic functions or analyses utilize this data. The Zymed Algorithm performs its analysis on the raw ECG signal and does not use the EASI derived 12-lead in that analysis. The Philips Holter Analysis System requires operator's intervention during and after the initial analysis. The Philips HAS allows the operator to view and print out an analysis report, individual heart rate strips, as well as a full disclosure report for physician's review, diagnoses, and observations. It is intended to assist the qualified medical professional in the interpretation of the recorded data; it is not intended to serve as a substitute for the review and overread of the recorded ECG data. The Philips Holter Analysis System provides viewing, printing, and report capabilities as listed below: - A view of the data and a summary of the heart events that have taken place - Detection of anomalies such as ventricular ectopy and supraventricular ectopy - Patency of the pacemaker and pacemaker anomalies - Advanced scanning techniques, such as determining ST and QT anomalies - Heart rate data and heart rate variability - Full disclosure reports The Philips Holter Analysis System can operate in a networked environment that includes the following devices and interfaces to transfer orders and Holter reports. - Philips IntelliVue Information Center (PIIC) (K153702) - A fleet of Holter Remote Links and one or more Holter Central Links - IntelliSpace ECG Management System (ISECG) (K120855) - An IntelliBridge Enterprise (IBE) data interface engine / brokering system - DICOM-based enterprise systems PIC , Holter Remote Links, and Holter Central Links provide alternate ECG input mechanisms for Holter analysis. ISECG Central Link, Report Viewer, and IBE can accept Holter reports. IBE can provide Orders and ADT information for HAS. DICOM-based systems support patient orders via DICOM Modality Worklist and accept exported DICOM Encapsulated PDF reports. The Philips Holter Analysis System provides three models with different configurations for customers to select: Series 3000, Series 5000, and Series 7000.

Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.

Philips Reusable ECG Lead Sets and Trunk Cables are non-invasive reusable medical devices designed to transfer ECG signals from the patient to the monitor used in the healthcare facilities, which includes intensive care unit (ICU) for both adults and neonates and the operating room (OR). The ECG cables and lead sets are used to forward an electrical cardiac signal via electrical wires from the electrode attached on patient skin to the ECG measurement hardware in the patient monitor and to support other outputs as needed. The portfolio consists of two types of trunk cables and two types of lead sets: ICU and OR, including various electrode connectors with AAMI and IEC coloring. The ECG Trunk cables and lead sets are suitable for multiple patient use. The Philips Reusable ECG Lead Sets and Trunk Cables have a service life of 18 months. The Philips Reusable ECG Lead Sets and Trunk Cables can be used with any Philips monitors including Philips monitor/defibrillator product lines and Philips monitoring or diagnostic equipment which claim compatibility to Philips Reusable ECG Lead Sets and Trunk Cables.

The Cardiac Workstation is intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations and interpretations for review by the user. The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation.

The Cardiac Workstation 5000 (aka: CW 5000) and Cardiac Workstation 7000 (aka: CW 7000) are intended to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user. They are to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations for review by the user. The interpreted ECG with measurements and interpretive statements are offered to the clinician on an advisory basis only. They are to be used in conjunction with the clinician's knowledge of the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to over-read and validate (or change) the computer-generated ECG interpretation. The CW 5000 and CW 7000 are mid- and high-range interpretive cardiographs, differing primarily in display size, the number of standard options. Both devices offer a full array of features built on the Linux operating system, with touch screen operation, a configurable feature set, and interpretation from the clinically proven Philips DXL ECG Algorithm (K132068). They provide a cardiograph solution for hospitals and cardiology clinics in processing large volumes of ECGs. The DXL ECG algorithm in the software analyzes up-to 18 leads of simultaneously acquired ECG waveform to interpret rhythm and morphology for a variety of patient populations. The measurements are then analyzed by the DXL ECG Algorithm. The resulting ECG reports may include ECG measurements, reasons, or analysis statements. The algorithm covers both adult and pediatric populations. The CW 5000 and CW 7000 consist of the following: - An electrocardiograph device with integrated display and printer. CW 5000 provides 12.1'' display panel. CW 7000 provides 15.6″ and 18.5″ options for the display panel. - Optional Trolley (ordered via a separate part number) The subject devices are further structured with options relating to software. Ul language, keyboard locale, and a wide range of other configuration choices to optimize the user's experience with the devices.

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 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 only for use on one patient at a time. They are not intended for use in transport situations. 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. 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 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 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 Masimo rainbow SET measurement is indicated for the nonitoring 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 intended 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 intended 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: Alfentani, Desflurane, Nitrous Oxide, Propofol, Remifentanil, and Sevoflurane. The Sedation Monitor is intended 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 IntelliVue Patient Monitors MX750 and MX850 acquire multiple physiological patient signals, display measurement values, waves and trends, generate physiological and technical alarms, provide data recording and support patient data management. They operate with the external Measurement Modules and the IntelliVue 4-Slot Module Rack FMX-4, which establishes the connection between the individual plug-in measurement modules and the MX750 and MX850 monitors. The monitors support multiple non-invasive measurements such as ECG, arrhythmia, ST, QT, SpO2, respiration rate, pulse rate, heart rate, invasive and non-invasive blood pressure, temperature, CO2, tcpO2/ tcpCO2, C.O., CCO, intravascular SO2, SvO2, ScvO2, EEG, BIS, NMT, and gas analysis. 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. These devices have a color display with a touch-screen as a primary input device. They also support keyboard and pointing devices such as a mouse. The monitor models MX750 and MX850 differ mainly in size. While MX750 has a 19" flat panel display, MX850 has a 22″ display.