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EKG-PLUS II Software is a Window-based program intended to receive, display, store and print out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device-CardioCare-2000 (Formerly, CardioCare EKG-2000) or CardioTouch-3000. The software can also store the ECG data as JPEG file.

The EKG-PLUS II Software is a program which receives, displays, stores and prints out in network environment the ECG data monitored, recorded and analyzed by a Bionet's ECG device.

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion. - Patient Population: Male/Female, Adults . - Environment of Use: Hospital and Clinic . - Prescription Device by a Physician ●

CardioView32 Review Module is a Window's based program intended to be called from a host application/database in a Hospital or in a Physician's Office. CardioView32 Review Module receives, analyzes, displays, stores and prints ECG *.scp files generated from a standard 12-lead ECG recording. Cardio View 32 Review Module provides interpretive statements for which the physician renders his/her own medical opinion.

To analyze multi-channel ECG signals from adult and pediatric patients 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. Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to rule-out causes for symptoms.

The Philips ECG algorithm Software Release PH100B is a modification to a previously cleared device. The modification is a change that provides interpretive analysis capability for additional posterior and right sided heart lead placement locations beyond the standard lead placements used with a 12 lead ECG. The modification also incorporates a subset of the diagnostic statement changes recommended in the Journal of the American College of Cardiology Volume 49, No.10, 2007, pages 1128-1135. "Recommendations for the Standardization and Interpretation of the Electrocardiogram".

The CARDIOTOUCH-3000 is intended to be used under the direct supervision of a licensed healthcare practitioner. The CARDIOTOUCH-3000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult population. The device is not intended for home use. The device is not designated for intracardial use.

As an electrocardiograph with 12-channel, CARDIOTOUCH-3000 does not only provide parameters and diagnose a patient automatically for patient's electrocardiogram, but also it improves chart management by printing information on an operator as well as on the patient. Furthermore, for the convenience of operators, it is designed so that an operator needs to press a button once to let the machine measure and record patient's electrocardiogram, apply a filter, extract parameters, diagnose a patient automatically then print out a result on an A-4- size report. In addition, the built-in battery helps an operator carry and use CARDIOTOUCH-3000 easily and conveniently for a hospital on wheel and an emergency.

The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable. It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings. It is intended to be used on the adult patient population.

Cardio-Card Interpretive System I

The OxyconAlpha with option ECG is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill. The patient population is 4 age and older, The OxyconAlpha with option ECG is capable of performing computerized ECG interpretation during resting condition. The intended use locations are either in a physician office, hospital exercise rehabilitation facilities, or similar areas. It is intended to be used by or on the order of a physician or similar qualified health care professional. This device is intended for use in the hospital environment, physician's office, or similar settings. This device is not intended for home use.

The OxyconAlpha with option ECG is a software-driven, medical device for exercise measurements, including ECG ST Segment Analysis and/or ECG Stress Analysis. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide excretion, heart rate and derived parameters. The results of the tests, including the ECG wave forms, can be viewed on the computer screen and can be printed during the test. The test results can be saved on the computer hard disk for further referral or report generation purposes. The OxyconAlpha with option ECG interfaces to a testsubject via a mouthpiece or a face mask and ECG electrodes. The OxyconAlpha with option ECG interfaces to a peripheral ergometer or treadmill.

The CASE 8000 exercise testing system is a diagnostic device intended to monitor and record electrocardiographic data from the patient during exercise, as well as perform resting ECG analysis. The intended use of the CASE 8000 exercise testing system is to acquire, process, record, archive, analyze, and output data during a period of physiologic stress or during a resting ECG condition. The CASE 8000 exercise testing system has the ability to calculate prognostic scores. A user selectable option can provide printout of prognostic scores on select reports. A vector loops report is also available. Ancillary functions include control of an external device (typically a treadmill or ergometer) and communications with centralized electronic/digital storage system. This device uses a computerized analysis program, which can be used as a tool in ECG tracing interpretation. The device records 12 lead ECG data taken in resting and exercise modes, as well as real-time rhythm and median morphology recordings. The device can perform a 12 lead interpretive analysis on the resting ECG, providing the user with statements of morphology, rhythm and conduction. The CASE 8000 exercise testing system is intended to be used by trained operators under the direct supervision of a licensed health care practitioner when exercise or resting ECG records are required. The CASE 8000 exercise testing system is intended to be used primarily in hospital based exercise testing laboratories, but can be used in clinics, physician offices, outreach centers or wherever exercise testing is performed. This device is not intended for use with high frequency surgical units. The CASE 8000 system is not intended to be used as a vital signs physiological monitor. This equipment will not cause abnormal operation of a patient's cardiac pacemaker or other electronic stimulator.

The CASE 8000 exercise testing system is a PC-based device capable of being operated as a stand-alone system or in conjunction with a centralized electronic/digital storage system such as the MUSE CV Information System - K980495 (MUSE). Major components include a CPU, display, modem, mouse, printer, keyboard, power supply, acquisition module and a cart. It is intended to be used primarily in hospital based exercise testing laboratories. It can also be used in clinics and outreach centers or wherever exercise testing is performed. The primary application of the device is to acquire, process, record, archive, analyze and output data during a period of physiologic stress or during rest. Ancillary functions include control of an external exercise device, typically a treadmill or ergometer, and communication with a centralized electronic/digital storage system such as the MUSE. When used in conjunction with MUSE, the CASE 8000 exercise testing system is capable of bringing computerized information management to the exercise laboratory. Demographic and order information can be downloaded to the system to simplify order management and data entry operation. Results from previous tests can be reviewed on the system after network download from the MUSE. New results can be quickly sent to the MUSE for long term storage.

The MAC Series Resting ECG Analysis Systems (Includes the MAC PC, MAC 6, MAC VU, MAC 8, and MAC 5000) are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC Series is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

The Mac Series consists of electrocardiograph models designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The devices consist of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment. The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of ORS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

The ECG-9010K and ECG-9020K Cardiofax GEM electrocardiographs are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes to produce a visual display and/or to prepare a record of the electrical signals produced by the heart. For non-interpretive applications, the ECG-9010K and ECG-9020K are intended for use with a full range of patient populations as determined by a clinician. The devices also provide an interpretive ECG program intended for use with patients age 3 years to adult. The interpretation program is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis. Assessments provided by the interpretation program are not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

The ECG-9010K and ECG-9020K have been classified as Class III by the Division of Cardiovascular. Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per 74 LOS. Common names for the ECG-9010K and ECG-9020K include ECG and electrocardiograph. Nihon Kohden's model ECG-9010K and ECG-9020K are intended for medical purposes to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and/or prepare a record of the electrical signals produced by the heart. The ECG-9010K and ECG-9020K devices comply with the IEC 601-1 standard including subclause 56.3(c) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for these devices. The devices are also in compliance with the following voluntary industrial standards: IEC 601-2-25 and CSA 601-1. Defibrillator Discharge Protection: Class I, Type CF. The ECG-9010K and ECG-9020K are not intended to be sterile. The devices were determined to be non-contacting. Therefore, good laboratory practice studies were not required per 21 CFR part 58. The ECG-9010K and ECG-9020K were subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation is performed to test the operation of the device software. The results confirm that the device performs within specifications.