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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.

The Frontier X Plus device is an ambulatory monitoring device intended to record, store, and transfer single-channel (ECG) rhythms for monitoring and evaluation. The Frontier X Plus system also displays ECG waveforms and ECG rhythm analysis; detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, inconclusive and unreadable rhythm. The Frontier X Plus is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. It is indicated for use on adult patients who may be asymptomatic or who may suffer from transient symptoms requiring cardiac monitoring. The device has not been tested for pediatric use. The Frontier X Plus is a prescription-only device, and the reported information is provided for review by a physician who will render a diagnosis based on clinical judgment and experience.

The Frontier X Plus is an ECG (electrocardiogram) event recorder that records, stores and transfers single-channel electrocardiogram rhythms. The device utilizes a proprietary algorithm, to analyze single-channel ECG. The Frontier X Plus hardware transmits the ECG signal from a dry electrode array embedded in the Frontier X Plus chest strap to the embedded Frontier X Plus firmware, integrated with the HeartKey ECG algorithm to be analyzed and presented to the user. All ECGs are synced with the user's account.

The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented for review by a medical professional. The data received from the Rhythm Express device can be used by another device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.

The Rhythm Express RX-1 will be worn by patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients. Note: This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool. CER-S analysis provides indications for, but not limited to, evaluation of: - Patients with rhythm disturbances (cardiac arrhythmias), - Patients with transient myocardial ischemia, - Patients with pacemaker (only if pacing detection is available from the input recording), - Patients needing HRV evaluation, - Newborn patients limited to QRS detection.

CER-S is a tool, designed to offer a framework for the interaction of different software-modules, providing advanced solutions for Continuous ECG Recording (CER). Different modules provide: ECG Beat detection and classification Analysis of ECG rhythm, arrhythmia detection interactive Viewer and set of tools to perform editing of ECG beats, Rhythm annotations and noise Windows interactive Continuous ECG Viewer interactive display/management of ECG Templates Holter-like report for analyzed Continuous ECG records, record exportation, in ISHNE format generation of aECG FDA HL7 XML (v. 2), for the submission of continuous ECG recording to the FDA ECG Warehouse. Note: The automatic analysis is limited to data acquired from electrodes with conductive paste/gel (dry and dry/metal electrodes are not intended to be used) placed on standard location in compatible formats from any device used for the arrhythmia diagnostics such as Holter, event recorder, 12-lead ambulatory ECG devices when assessment of the rhythm is necessary. Moreover, CER-S allows the automatic analysis for the following patch location: two-electrode patches positioned in the left upper chest area at a roughly inclined angle three-electrode triangular shape patches positioned on the patient's left upper chest area below the 1st rib, at an inclined angle three-electrode T-shaped patches positioned in the center-thoracic position between the upper part of the chest (manubrium) and the sternum In all cases, patch placement must strictly follow the indication provided by the manufacturer of the certified-patch device.

The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments. Faros Mobile provides the detection and reporting features appropriate for the indications below - · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias. - · Evaluation of patients for ST segment changes - · Evaluation patients with pacemaker - · Evaluating patient rest and stress ECG - · Reporting heart rate variability analysis - · Wireless transmission of patient ECG data and arrhythmia events for further analysis. Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements. Faros Mobile is contraindicated for - · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias - · Pediatric patients weighting less than 10 kg

Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes. Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software. In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes. Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application. Faros Mobile system consists of: - . Faros ECG sensor - o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor - channel and 3-channel cable sets o - general micro-USB cable for recharging device O - Faros Manager application - Cardiac Explorer application - Cardiac Navigator application

The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis. The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years): - · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia. - · Evaluation of patients for ST segment changes - Evaluation of patients with pacemakers - · Reporting of time domain heart rate variability - · Evaluation of a patient's response after resuming occupational activities (e.g., after MI. or cardiac surgery.) - · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients - Clinical and epidemiological research studies

The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings, depending on the recorder and patient cable type being used. The Cardiospy ECG Holter System includes a recorder, an USB dongle (for blue tooth communication) and the Cardiospy software. The Class II medical device is intended to acquire, record and store up to 24, 48, 72 hours and 1 week of ECG data of patients that have been connected to the recorder and are undergoing Holter monitoring and to support the medical staff in analyzing and deciding the proper and adequate diagnosis. The cardiac data and analysis provided by Cardiospy ECG Holter System will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The universal analysis SW provides full disclosure ECG recordings on channels with a precise automatic QRS and PM detection, template and rhythm analysis, QRS classification, efficient ST, QT, AF, PM, HRV time and frequency based analysis with color coded display and printing with interactive modification possibilities in the automatic analysis in several languages. Exportavailable. The evaluation software works with a conventional PC- based computer under Win 2000/XP/VISTA , Windows 7, Windows 8 operating systems. The connection between the Holter and computer is performed by using Bluetooth and USB dongle. The Cardiospy analysis software provides ECG records of excellent quality.

The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

The CV3000 Holter Analysis System is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities. The CV3000 Holter Analysis System is consisting of Holter recorder and the PC-based CV3000 Analysis Software. The Holter recorder is an ambulatory electrocardiograph designed to be used with the PC-based CV3000 Analysis Software. It is intended to acquire, record and store up to 24 hours of ECG data from the patient. It performs no cardiac analysis by itself and is intended to be used with the CV3000 analysis software. ECG data prerecorded by the Holter recorder is analyzed by the CV3000 analysis software.

The AUDICOR System when used with an AUDICOR Sensor on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, body position, Sleep Disordered Breathing (SDB) and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The SDB analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Patients screened for SDB should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The AUDICOR System employs the Hemo ambulatory recording device to capture 10-second snapshots or up to 48 continuous hours of physiologic data. ECG, heart sounds, body position, sleep disordered breathing, snoring sounds, and activity level are interpreted from the physiologic signals captured. The AUDICOR System includes software to analyze recorded data, then display and present a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The AUDICOR System analyzes and reports the following parameters: - Heart rate including bradycardia and tachycardia events . - Atrial fibrillation . - ECG beat classification and morphology grouping with user-editing l - . Heart rate variability - Snoring detection . - Sleep disordered breathing (apnealhypopnea) events - . Sleep disordered breathing score - Activity level . - . Body position - Heart sound and combined ECG/heart sound measurements . - Heart rate distributions of heart sound parameters The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.

The AUDICOR System when used with AUDICOR Sensors on the chest wall and properly attached Holter unit, is intended for use on adults 18 years of age and older in acquiring, analyzing and reporting ECG, heart sound, sleep disordered breathing and snoring detection and to provide interpretation of the data in an integrated report for consideration by physicians. The sleep disordered breathing analysis and reporting is intended for use on adult patients only as a screening device for obstructive or mixed apnea to determine the need for evaluation by polysomnography based on the patient's score. Subjects screened for sleep disordered breathing should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. The AUDICOR recording may be obtained at any location specified by a physician including home, hospital or clinic. The device is intended for use only under the direct supervision of a physician.

The Audicor CPAM with SDB (Cardiopulmonary Holter with Sleep Disordered Breathing detection) is an ambulatory device that can be used to capture 10second snapshots or up to 48 hours of continuous data from ECG, heart sounds, sleep disordered breathing and snoring detection, and activity level, particularly in patients suspected of heart failure or acute coronary syndrome. The Audicor CPAM with SDB includes software to display, analyze and provide a summary of patient data over time in a trended format. Notable events are detected and displayed for review by the clinician. The Audicor System analyzes and reports the following parameters: Heart rate including bradycardia and tachycardia events . Atrial fibrillation . ECG beat classification and morphology grouping with user-editing . . Heart rate variability . Snoring detection Sleep disordered breathing (apnea/hypopnea) events . Sleep disordered breathing score . Activity level - Heart sound and combined ECG/heart sound measurements - Heart rate distributions of heart sound parameters ● The clinician can review automatically detected events and measurements, and modify them as well as modify the interpretative statements generated.