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1Safety and Warning Information
The DigiTrak XT Holter Monitor is a battery operated solid state recorder, designed for up to
168 hours (7 days) continuous recording of ambulatory electrocardiograph (AECG) data. It
has the ability to detect and record pacemaker pulses according to the appropriate criteria for
AAMI pacer detection.
The DigiTrak XT is an AAMI Type I device and part of a conventional AECG monitoring
system where an ECG is recorded in Multi Media Card (MMC) memory within the recorder.
After the recording is complete, the DigiTrak XT recorder is connected via the docking station
to a USB port on the Holter computer. Follow the instructions provided with the Holter
application to download and analyze the recorded ECG data.
Indications for Use
The DigiTrak XT Holter recorder is intended for patients requiring ambulatory (Holter)
monitoring.
CAUTION The DigiTrak XT recorder is not intended for use on infants weighing under 10 kilograms
(22 pounds), as required by IEC 60601-2-47:2001.
Such monitoring is most frequently used for the indications below:
Evaluation of symptoms suggesting arrhythmia or myocardial ischemia
Evaluation of ECG documenting therapeutic interventions in individual patients or groups
of patients
Evaluation of patients for ST segment changes
Evaluation of a patient's response after resuming occupational or recreational activities
(for example, after myocardial infarction or cardiac surgery)
Clinical and epidemiological research studies
Evaluation of patients with pacemakers
Reporting of time and frequency domain heart rate variability
Reporting of QT interval
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