Mortara T12, User Manual

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INTRODUCTION
SECTION 1
1
Manual Purpose
The T12™/T12S™ digital ambulatory transmitter user manual explains how to:

Acquire and transmit 12-lead ECG signals to a receiving device

Acquire and transmit pulse oximetry (SpO
2
) signals to a receiving device

Setup device configurations
NOTE: This manual may contain screen shots. Any screen shots are provided for reference only and are
not intended to convey actual operating techniques. Consult the actual screen in the host language for
specific wording.
Audience
This manual is written for clinical professionals who are expected to have a working knowledge of medical
procedures and terminology as required for monitoring cardiac patients.
Indications for Use
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 non-invasive arterial
oxygen saturation monitoring.

Indicated for use on hospital patients of any age where ambulatory monitoring of ECG and SpO
2
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.