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The T12S Telemetry Transmitter is a non-invasive prescription device

• indicated for use as a radiofrequency physiological signal transmitter that acquires and delivers RF transmission of real-time electrocardiographic and pulse oximetry data obtained during physiologic stress exercise testing and ambulatory patient monitoring.
• indicated for use in a clinical setting, by qualified medical professionals, properly trained for ECG monitoring and use of the system. The personnel must be 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 pulse oximetry sensor is indicated for use for continuous or spot monitoring of noninvasive arterial oxygen saturation monitoring.
• indicated for use on hospital patients of any age where ambulatory monitoring of ECG and SpO2 data is done (e.g. patients in Coronary Care Units, Step-Down Units, Emergency Departments, stress testing or rehabilitation departments).
• It is not designed for out of hospital transport.
• It 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 T12S and T12 Telemetry Transmitters are non-invasive prescription devices positioned for typical use within a clinical setting of ambulatory patients in a centralized monitoring system or other clinical settings where such telemetry is used. The Telemetry Transmitters are patient-worn diagnostic tools intended to acquire, and transmit real time ECG and SpO2 data of ambulatory patients that require ECG monitoring during cardiovascular problematic situations.

When used within a compatible multi-parameter Telemetry Central Station system, the Transmitters are designed to transmit ECG data only (T12 version) or ECG and SpO2 data (T12S). The mode will be selectable, The Transmitters will typically be used for centralized ECG monitoring in a telemetry system consisting of three main components: the ambulatory ECG telemetry transmitters (T12S or T12 Transmitters), the compatible receivers combined with an antenna network and a compatible multi-parameter Central Station software application running on a PC.

The T12 incorporates wireless electrocardiographic technology to achieve acquisition and RF transmission of simultaneous real-time 12-lead ECG data with diagnostic quality to a Mortara receiver module while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals to a compatible monitoring device where the signals are displayed, without direct connection to an electrocardiograph.

The T12S integrates wireless electrocardio and pulse oximetry technology in one device to achieve real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality and pulse oximety measurement values and waveform data to a Mortara receiver module while allowing the patient to be ambulatory. It provides a means to acquire and transmit 12-lead cardiac signals and pulse oximetry measurement to a compatible monitoring device where the signals are displayed without direct connection to an electrocardiograph or separate pulse oximeter device. The T12/T12S affords the patient complete freedom of movement. Unlimited range can also be obtained with the addition of Mortara antenna network units.

T12 / T12S Transmitters are designed to work with real-time efficiency within a multiple transmitter environment without interferences. The individual transmitter can be configured on one of 256 specific channels and allows the user to increase or decrease the channels until the desired one is selected. A design option will allow the user to set the patient cable to 5 or 10 lead-wires.

The unit operates from a single "AA"-type battery and has an internally integrated antenna which is not removable or accessible. It contains an LCD that is used for setup and status. During setup, the user can configure the unit to transmit ECG waveforms and SpO2 data, patient demographics, and other user selectable options. A language option will allow the selection of the applicable user interface language. While in normal operation, the display will show status information such as a battery gauge and lead-fail information. The user can navigate through menu options and turn the unit on and off. A front button functions as a patient alert button in normal use.

The patient hookup acquires a continuous 12-lead EGG signal. The signal is A/D converted and the digital data is sent to a compatible centralized monitor using wireless radiofrequency communication. The antenna network receives the data sent by the transmitters. The network delivers the signal to the receivers installed in a compatible Central Station PC. The receivers decode the signals and status from the transmitters for monitor display and review.

The provided text is a 510(k) Device Summary for the Mortara T12S Telemetry Transmitter. It outlines the device's description, intended use, and indications for use, as well as its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or any study data proving the device meets such criteria.

Therefore, I cannot populate the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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