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The primary use of ambulatory monitoring are listed below. - 1 Evaluation of suspected of known cardiac rhythm disorders. - 2 Evaluation of symptoms suggestive of an arrhythmia disorder. - 3 Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death. - 4 Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense. - 5 Evaluation of chest pain. - 6 Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment. - 7 The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software. Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

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The GALIX ECG Professional Station system is intended for 12 Channel ECG recording and monitoring (running the ECG-PS software module) and 12 channel cardiac stress testing (running the ERGO-PS software). It is indicated for use: - with Male/Female Pediatric to Adult population - in Hospital, Clinic and Physician´s office - under prescription by a physician

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The GALIX WinTer ECG Holter Analysis system is intended for patients requiring 24hr ambulatory monitoring. It is indicated for use in: - the replay, analysis, display, editing and report generation of ambulatory ECG data - . the assessment of cardiac disturbance and myocardial ischemia

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The GALIX PaceStar External Paccmaker may be used in any clinical situation in which the use of a temporary pacemaker on a patient provides therapentic or diagnostic value. Specifically, indications for teaporary paccusions include, but are not limited to, the following: - temporary treatment of arrhythmias and heart block . - pro-, intra- and postoperative temporary stimulation of patients undergoing cardiac surgery .

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The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of Very High Resolution ECG, at a sampling rate of 1000 samples per second. The ECG data stored is then analyzed with the Late Potential Software, Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

GALIX GBI - 3S - LP Digital Holter Recorder

Electrocardiographic recording to document a patient's arrhythmia has had widespread application as a non invasive tool in cardiology. A patient's arrhythmia may be with application as a lectrocardingram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring or continuous ambulatory electrocardiographic monitoring has been a useful technique for patients with cardiac arrhythmias. Indications for Holter monitoring are listed in Table I. The primary use of ambulatory monitoring is for the evaluation of cases of suspected cardiac rhythm disturbances. Since these archythmias can be episodic, detection of complex ventricular arrhythmias will vary, depending of the duration of the recording. A 24 - hour Holter recording permits the recording of cardiac rhythm during both sleep and awake states. Thus the variation of arrhythmias during waking hours and during physical and mental stress can be demonstrated. TABLE I: Indications for Holter monitoring 1 - Evaluation of suspected or known cardiac rhythm disorders. 2 - Evaluation of symptoms suggestive of an arrhythmia disorder. 3 - Evaluation of clinical syndromes in which arrhythmias may increase the risk of sudden death. 4 - Evaluation of pacemaker function. 5 - Evaluation of chest pain. Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment. Holter monitors are frequently used as part of diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects. Because of spontaneous variability of a patient's arrhythmia these studies are often limited and should be viewed with caution. Studies that have used longer monitoring periods may be more accurate. Holter monitors may also be used for screening patients with symptoms suggestive of sinus node or AV node conduction problems. Holter monitoring can be useful in correlating episodes of chest pain with diagnostic ST segment abnormalities. Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death. Such situations include the period after myocardial infarction." Congestive heart failure and dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, and the congenital prolonged QT syndrome. Holter recordings may also be useful in screening for arrhythmias in patients with the mitral valve prolapse syndrome and in those recovering from coronary artery bypass surgery. Holter monitoring can also be used to screen patients with symptomatic or asymptomatic Wolff - Parkinson - White syndrome. Patients who have suspected pacemaker malfunction may also require longterm monitoring to document an intermittent episode of failure to capture or failure to sense. These abnormalities and oversensing problems may be easily documented during ambulatory monitoring.

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER