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The device is intended to acquire and transmit electrocardiograph (ECG) data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.
The device is to be used on ambulatory adult populations where monitoring is prescribed while undergoing exercise rehabilitation.
Multiple central receivers may be used and connected to a local area network.
Specified wireless data entry devices may be connected to the system via a wireless access point and be used as a station for entry of patient session data.
Optional workstation(s) may be connected to the system via a network for entering and viewing patient demographic and rehab session data. The workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms.
ECG analysis may include 12-lead ECG interpretation.
Patient demographics, exercise prescription, scheduling information, and collected data can be ported to an outcomes management program.

The Q-Tel RMS telemetry system measures the electrical activity of a patient's heart during an exercise class and transmits it via radio frequency to a central monitoring station. The core features of the O-Tel RMS system include telemetry monitoring, ECG displays, full disclosure of vital signs, printing and reporting, and rehabilitation program management, such as scheduling classes and seminars and patient enrollment.

The monitoring station displays the patient's real-time ECG waveforms and uses programmable alarms to indicate the presence of pre-selected medical or technical conditions, such as arrhythmia or loss of signal. When alerted by the alarm, the clinician determines whether the event causing the alarm is clinically significant or benign. The Q-Tel RMS system enables the clinician to view, edit, record ECG strips, and use a printer to print reports.

Optional workstation(s) may be connected to the Q-Tel RMS via a network for the purpose of entering and viewing patient demographic and session data, which is stored on the Q-Tel RMS system. A workstation may also be used for tracking patient progress in cardiac rehab and displaying non-real-time waveforms and alarms. Workstation(s) may be supplied as a turnkey device or as software only to be installed on specified hardware platform supplied by the customer. The software only workstation provides the same functions as the turnkey workstation except viewing of session data in "read-only" mode.

An optional wireless data entry device, such as a PDA, may act as a station for entry of patient session data which is saved on the Q-Tel RMS system. The wireless entry device has access only to patient session data.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device (Q-Tel RMS) seeking substantial equivalence to a previously cleared device. It focuses on comparing the technological characteristics and intended use of the new device with its predicate device to demonstrate that it is equally safe and effective.

Therefore, I cannot provide the requested table or study details based on the input.

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