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The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only. The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following: - . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application - Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation. Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter). The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation. The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

The ASSURE Wearable ECG is indicated for adult patients who have been prescribed this device by a medical professional, who were previously prescribed the ASSURE WCD system, and who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, presyncope, syncope, fatigue, or anxiety. The signal acquired by the ASSURE Wearable ECG is not intended and should not be used for automated or semi-automated analysis. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The ASSURE Wearable ECG is contraindicated for use in patients with an active implantable pacemaker or defibrillator.

The ASSURE Wearable ECG is a reusable, ambulatory electrocardiography-based, cardiac- and physiologicmonitoring, medical-electrical system whose intended purpose is to inform clinical management of options for diagnosing, monitoring and/or mitigating cardiac conditions after patient's improvement following ASSURE® Wearable Cardioverter Defibrillator (WCD) prescriptive use. The system utilizes the same five-electrode SensorFit™ Garment worn previously with the WCD prescription. The system continuously records ECG data and upon detection, it identifies and records episodes as high and low heart rate, as well as patient-triggered events. The system utilizes the same algorithm detection and episode reporting software marketed in the ASSURE WCD with high (Tachy) and low (Brady) capture for later transmission to the medical professional for interpretation. The system captures and stores ECG episodes, and non-ECG patient activity and wear information to be displayed and reported in counters and trends. Recorded events include ECG waveforms and reports identifying high and low heart rates, as well as patient-triggered events. The system uses a 3axis accelerometer to monitor non-ECG patient activity (steps and wear time). The ASSURE Wearable ECG event reports do not contain diagnostic interpretation. The reported events are provided for review by the prescriber to assist in diagnosis of the recently transitioned WCD patient and to assess care options based on the healthcare professional's judgment and experience. The ASSURE Wearable Cardiac ECG is a prescription use device. The ASSURE Wearable ECG is intended for use by a patient during their normal daily activities primarily in the home or community setting, but also hospitals, medical clinics, healthcare facilities and transport. The device is non-invasive, and intended to be used on one patient at a time. The Wearable Cardiac ECG System is comprised of the following reusable patient-worn components: - Monitor Cable Assembly - Hub - Alert Button - Battery Pack - SensorFit™ Garment - Charger

The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient's electrocardiogram. The recorder is intended to be used by either paediatric or adult patients suspected of cardiac arrhythmias in either a clinical setting or at home. The recorder does no cardiac analysis and is used with Spacelabs Ambulatory ECG Analysis Software.

The Eclipse MINI Model 98900 (Eclipse MINI) is an ambulatory electrocardiograph (ECG) recorder capable of providing a 3-lead recording. It is connected to the patient using a custom, disposable, single-patient only, 3-lead sensor patch that is adhesively attached to the patient's chest. The Eclipse MINI is powered by batteries that are integrated in the Eclipse Sensor Patch. These batteries are primary cells which cannot be recharged and power the recorder for up to 15 days. For an extended recording multiple Eclipse Sensor Patches may be required. The single patient event button allows the patient to indicate symptomatic episodes in the recording for correlation with the patient diary. The Eclipse MINI is fully sealed and waterproof. The Eclipse MINI is attached to the "holster" of the Eclipse MINI Sensor Patch by inserting the USB connector on the sensor patch into the USB receptacle on the bottom of Eclipse MINI housing. Patient data from the Eclipse MINI is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse MINI, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. The Biotres Recorder is an ECG recording only device and does not include ECG analysis, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. The Biotres Recorder has two buttons: 1) power button and 2) patient event marking button. There is an LED "status indicator light" in the middle of the patient event marking button that provides recorder status indications. The Biotres Recorder attaches to the patient's chest through three standard commercially available ECG electrodes. Biotres includes a Bluetooth modem to communicate with the Biotres Configured Secure Server through the Biotres Gateway Application. The Biotres Recorder integrated memory can store up to 30-days of ECG data. This data can be uploaded by the clinician to the Biotres Configured Secure Server. The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. The ECG recorded data is transferred via the Biotres Gateway App via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Clinicians can use the Biotres Gateway Application using their privileged login credentials to connect Biotres Recorders to the Biotres Configured Secure Server so that patient studies may be started and completed. The Biotres Gateway Application can be used by the patient once registered (nonprivileged login credentials) and the patient can use the application to monitor the status indicators of the Biotres Recorder and to enter symptoms if the Event Marking Button is pressed on the recorder. The ECG recorded data from the Biotres Recorder can be transferred, by the clinician, from the Biotres Configured Secure Server when the recorder is connected to the Biotres Gateway App at the end of a patient study. The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete. Biotres does not provide the patient or clinician with diagnostic or interpretive statements based on the ECG data. Biotres ECG recordings can be viewed through the Bioflux Software II (K201040) by qualified medical personnel.

The Medicalgorithmics' Q Patch is intended to be used by patients who have a demonstrated need for extended cardiac monitoring and patients with symptoms that may be due to cardiac arrhythmias such as, dizziness, lightheadedness, shortness of breath, palpitations, dyspnea (shortness of breath), anxiety, syncope of unknown etiology in which arrhythmias are suspected or need to be excluded. It is indicated for use on adult patients. The sensor records single ECG channel for up to 15 days and can be used on patients with implanted pacemakers but is not intended to record pacemaker activity.

The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient's ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch's memory can be downloaded through a USB port using the Q Patch Downloader (PC application).

The Biotres is indicated for use on adult patients 18 years or older who may be asymptomatic or who suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light headedness, pre-syncope, fatigue, chest pain and/or anxiety and may require cardiac recording on a continuous basis for up to 30 days. The signal acquired by the Biotres is not intended and should not be used for automated or semi-automated analysis.

The Biotres system consists of 1) the Biotres Recorder, 2) a dedicated Biotres AC wall charger, 3) Biotres Gateway application for use on mobile devices using Android or iOS, and 4) Biotres Configured Secure Server. Biotres Recorder: The Biotres Recorder is an ECG recording only device and does not include ECG analysis, an ECG viewer/EGG display, alarms and is not a real time ECG monitor. The Biotres recorder is a small, lightweight, ambulatory, reusable 3 channel ECG recorder that is placed on the center of the chest. Biotres AC Wall Charger: The dedicated Biotres AC Wall charger is used to charge the Biotres Recorder daily when disconnected from the patient. Biotres Gateway Application: The ECG recorded data is transferred via the Biotres Gateway App (Downloaded from the app store for iOS or Android respectively) via a Bluetooth connection and subsequently to the Biotres Configured Secure Server. Biotres Secure Server: The Biotres Configured Secure Server is an SFTP server that is configured to work with the Biotres System. The server enables the Clinician, through secured login, to command the Biotres Recorder (e.g. initiate ECG data collection) and to access uploaded MIT16 ECG data recordings when the ECG data collection is complete.

The Spacelabs Model 98700 is a portable non-invasive Holter recorder intended to record the patient's ambulatory electrocardiogram. The device is intended to be used by either pediatric or adult patients in either or at home. The device does no cardiac analysis and is used with a Holter Analysis System.

The Eclipse PRO Model 98700 (Eclipse PRO) is an ambulatory electrocardiograph (ECG) recorder capable of providing a true 12-channel recording for up to 72 hours or a 3-lead recording for up to 14 days. It is connected to the patient using Eclipse PRO-specific 3, 4, or 10 lead wire cables with the recorder located in a pouch on a lanyard. The Eclipse PRO has a large, color display which allows the user to view recorder status, configure the recorder and to view ECG lead application. It has an internal, fast-charge, long-life, rechargeable lithium-ion battery, which is charged when connected by a cable between the USB port of a personal computer (PC) or a USB charger, and the recorder's USB-C connector. Two (2) arrow keys on the front of the Eclipse PRO are used to navigate and select options in the recorder's menu or as a patient event button when the patient desires to indicate symptomatic episodes in the recording. The Eclipse PRO is fully sealed and waterproof. Patient cables are attached to the Eclipse PRO using the USB connector on the bottom of the housing and protective cable retention loop. Patient data from the Eclipse PRO is downloaded to a PC upon which the Spacelabs Sentinel Cardiology Information Management System (Sentinel), cleared in 510(k) submission K152881, has been installed. This allows the clinician to download, view, and analyze patient data from the Eclipse PRO, and create reports. Further analysis of these patient data can be performed by using Spacelabs Pathfinder SL Holter Analyzer (cleared in 510(k) submission K110001) and/or Spacelabs Lifescreen PRO Analyzer (cleared in 510(k) submission K201921). Finally, a non-medical device mobile phone app is available for patient use as an electronic note taking option in lieu of a manual, written patient diary.

The Integrated CardioRespiratory (ICR) System, when used with ICR Acoustic Sensors and ECG Sensor Electrodes on the chest wall, is intended for use in acquiring and analyzing heart sound data and computing and reporting an estimate of left ventricle Ejection Fraction that is comparable to that derived by 2-D echocardiography. The device is not intended for continuous monitoring of Ejection Fraction. The ICR System is not intended as a sole means of diagnosis. It does not supersede the judgment of the qualified medical personnel. The ICR System is intended to aid the physician in the evaluation of heart function. The interpretation of EF values offered by the ICR System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data. Indicated for use in adults only. The ICR System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.

The Integrated CardioRespiratory (ICR) System is a non-invasive skin adhering sensors and computer based device that allows for measurement of Ejection Fraction (EF). The ICR System includes four acoustic sensors and ECG electrodes that are placed on the patient's chest to collect signals, which are combined to compute the EF percentage value. The ICR System performs signal processing computation to identify and characterize amplitude and time of event characteristics of S1 and S2 heart sounds. The computed EF percentage value is presented to the clinician on the ICR Patient Monitor display. The ICR System consists of the following components: 1. ICR Acoustic Sensors 2. ECG Sensor Electrodes 3. ICR Sensor Application System 4. ICR Patient Monitor

The NR recorder is intended for patients requiring: · Ambulatory (Holter) monitoring · Use within the physician office setting by the medical professional ECG monitoring (using Bluetooth communication) - Resting - Telemetry ECG monitoring (using Bluetooth communication) Such monitoring is most frequently used for the indications below: · Evaluation of symptoms suggesting arrhythmia or myocardial ischemia · Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients · Evaluation of patients for ST segment changes · Evaluation of a patient's response after resuming occupational activities (for example, after myocardial infarction or cardiac surgery) · Clinical and epidemiological research studies · Evaluation of patients with pacemakers · Reporting of time and frequency domain heart rate variability · Reporting of QT interval

NR Recorder

The H3+ Holter recorder is intended to acquire, record and store continuous ECG data as directed by a clinician from adult, adolescent, pediatric, infant and neonate patient populations for a maximum recording time of 14 days in a hospital, clinic or home environment. The H3+ performs no analysis by itself and is intended to be used with a compatible ambulatory ECG (Holter) analysis system which will analyze the recorded data. The H3+ data analysis are then reviewed by trained medical personnel for the purpose of forming a clinical diagnosis. The H3+ Holter Recorder is not a life-supporting device.

The H3+ Holter Recorder is part of a Holter Analysis system. The H3+ Holter Recorder provides multiple channels of continuous multi-day ECG data recording and pacemaker spike detection markers. The H3+ Holter Recorder is extremely small and lightweight. The H3+ includes a display that allows the clinician to confirm patient identification, preview the waveform, and check the quality of lead connections during patient hook-up. The H3+ also has a patient activated event button which allows the insertion of event marks into the recorded data if directed by the clinician. The H3+ uses a single battery and stores acquired data in digital form on internal, non-volatile memory. Stored data is then imported for analysis at a compatible Holter analysis system [ e.g. HScribe (K004017) or Vision (K945985)]. The recorded data will remain in memory until it has been cleared by the clinician. The data provided by H3+ to the Holter Analysis system is used by trained medical personnel to assist in the diagnosis of patient conditions.