Search Results

The Midmark IQecg is indicated for use, under the supervision of a Physician, to obtain electrocardiograms from the adult and pediatric human body surface. The process of taking an electrocardiogram is non-invasive, painless, without direct risk to the patient and is reproducible.

The Midmark IQecg is a PC based 12-lead resting diagnostic electrocardiograph with interpretation and data storage capabilities. Together with the Midmark IQmanager software running on Microsoft Windows operating systems, the IQecg device can acquire 12-lead ECG (electrocardiogram) data, generate ECG measurement and interpretation results, provide review/edit functions to modify the measurement and interpretation results, store the ECG data and report in a database, archive the ECG reports for future reference and share the ECG reports with other physicians via network or email. The IQecg can also be connected to servers and electronic medical records.

The IQvitals and IQvitals System is intended to be used by clinicians and medically qualified personnel for measuring adult and pediatric patients for noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arterial hemoglobin (SpO2), temperature and weight. Patient information such as name, age, height, pain score etc. can be entered manually.

The IQvitals and IQvitals System are patient monitors intended to be used by clinicians and qualified medical personnel for spot check monitoring of noninvasive blood pressure (NIBP), pulse oximetry (SpOz), temperature and for the IQvitals device, weight. Patient Record information, such as height, respiration rate and pain level, can be manually entered by clinicians via the user interface.

IQmark EZ Stress is intended to be used under the supervision of a physician, in hospitals, clinics and physician's office, to acquire, display, process, record, analyze and print the patient's electrocardiograms from the human body surface during stress induced from exercise devices such as a treadmill, a bicycle ergometer or drug induced (pharmacological) stress. The device may provide interfaces with external devices, such as a treadmill or an ergometer, non-invasive blood pressure equipment, and computer communication equipment. The device is not intended to be used as a vital signs physiological monitor.

The IQmark EZ Stress test system is a computer-based diagnostic electrocardiograph that is designed for exercise stress test. The IQmark stress runs on the Microsoft Windows environments and can control a treadmill or an ergometer through a serial port. The IQmark EZ Stress provides real time ECG data acquisition, waveform display, and ORS detection. It calculates the heart rate, detects ventricular ectopic beats, generates the average beats, measures the ST segment levels and slopes, generates the test reports, and stores the reports in the database. The IQmark EZ Stress system also provides reports and FCG strip printing and review and editing capabilities for trained personnel to manage the patient`s report.

The intended use of the IQmark Digital Holter is for evaluation of the recorded ambulatory ECG for patients who need ambulatory monitoring, such as, but not limited to, those have complaints of chest pain, palpitations, dizziness, shortness of breath, or those have pacemaker implanted. The evaluation includes measurements and statistics of arrhythmia, R-R variability and ST segment changes in the recorded ECG data. The computer-generated results do not contain diagnostic interpretation, intended users are expected to review the report. The IOmark Digital Holter is intended to be used only by physicians or on the order of a physician. The intended use of the IOmark Digital Holter as described in its labeling has not changed from the cleared device, Rhythmscan Precision 6000 (K914577).

The IOmark Digital Holter is a software program that analyzes recorded ambulatory ECG (Holter) then creates statistical reports based on analyzed data. The ambulatory ECG, as well as pacemaker pulse detection data, is pre-recorded onto data storage mediums by Holter recorders. The IQmark Digital Holter software reads these raw data into computers then performs analysis to generate statistical reports. The IQmark Digital Holter software provides review and editing tools that allow trained medical personnel to review and edit the initial analysis results to diagnose patients. The IQmark Digital Holter software does not provide diagnostic interpretation. The IQmark Digital Holter software also provides statistical results of pacing events for pacemaker patients. Like other features in the software, Holter scanning operators can review and edit, if necessary, any analysis results.

The intended user is a medical device manufacturer who will integrate the ST/AR Library into a computerized cardiac monitoring device. The ST/AR Library integrator will ultimately identify the indications for use, depending on the nature of their device. The analysis capabilities of the ST/AR Library are indicated for monitoring and detecting the following from up to 12 body surface ECG leads for adult, pediatric, or neonatal patients: - QRS detection - ventricular ectopic beat detection (non-paced only) - rhythm call analysis, including asystole, bigeminy, couplets, irregular heart rate, pause or missed beat, VEB/minute, run, trigeminy, triplets, ventricular tachycardia - ST segment level measurement (adult patients only) - ventricular fibrillation detection

The Brentwood Real Time ST and Arrhythmia Analysis Software Library is an "object library'. An object library is a collection of callable functions that have been compiled (or assembled) into the native machine code of the computer on which they will execute. An application software program can be written to invoke some or all of the functions in an object library. The compiled (or assembled) application code can be "linked" to the called functions from an object library at the time the executable code image is built. An executable code image created in this manner will contain the application software code and all of the functions it invoked from the object library. The Brentwood Real Time ST and Arrhythmia Analysis Software Library consists of a collection of ANSI Standard C (ISO/IEC 9899) callable functions. It provides real time ECG signal processing, QRS detection, QRS complex feature extraction, ventricular ectopic beat detection, ST level measurement, rhythm calls, and ventricular fibrillation detection capabilities for up to 12 leads of captured ECG lead data. Brentwood will compile the Brentwood Real Time ST and Arrhythmia Analysis Software Library using the compiler specified by an ECG analysis device manufacturer. An object library will be created and delivered to the manufacturer, who can then integrate it into application software for their ECG analysis device(s).