Search Results

The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs. The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor. The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.

The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device collects and uploads a dedicated patient's ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system. The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythm data to a iOS® mobile device using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Clinical Client Application software (Spaulding ECG) to collect a 12-lead ECG. The Spaulding ECG application then communicates to the Spaulding webECG server to upload ECG data through an Internet connection.

The IQ Electrocardiograph is a non-invasive prescription device that is indicated for use: - The proposed IQ Electrocardiograph is indicated for use to acquire, analyze, display and print electrocardiograms. - The device is indicated for use for pediatric and adult populations, diseased or non-diseased. The device is not indicated for use for neonatal (birth to 28 days) of infants (29 days up to 2 years). - The interpretations of ECG data offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. - The device is indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The person proust he experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements. It is not intended as a sole means of diagnosis. - The device is not intended to be used as a vital signs physiological monitor. - It is not designed for out of hospital transport. - lt is not designed for use in highly invasive environments, such as an operating theatre. - The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns.

The proposed Spaulding IQ is an electrocardiograph that combines proprietary hardware, current industry technologies and an off-the-shelf personal computer to achieve a highly reliable electrocardiograph. The IQ is a standard 12-lead non-interpretive electrocardiograph system that is indicated for use by qualified medical professionals in a clinical setting. The IQ combines proprietary hardware and an off-the-shelf personal computer. The concept behind the IQ is to provide the user with an ECG acquisition module that can also transfer the acquired ECG record to a participating PC. The PC side of the system will employ installed proprietary software applications to record and process it for display, printing and storage, or further processing. The device may be used in medical clinics and offices of any size, to include Clinical Research Organizations. The system will be based on two major components: - An ECG acquisition module that can (1), acquire the patient demographics by means of an incorporated voice signal input component that uses current industry voice recognition technology and (2) acquire a patient 12-lead ECG. The patient ECG and voice signal data will, be stored on the module in local memory and subsequently transferred to a PC Station via a standard USB connection. - Proprietary Software Application(s) (Mason Protocol) installed on a participating networked PC, that will receive the ECG data from the Acquisition Module and will communicate bi-directionally to the Clinical Server (CTS) and gather/transmit information about the patient's demographics, visit information as well as acquired ECG data. The application controls user access and authentication, submits the resulting ECG and demographic and visit information to the Clinical Server and allows the user to select the appropriate visit protocol and enter patient's demographic and visit data.