Welch Allyn Holter System - User Manual - Manual (Page 6)

2 Directions for Use Welch Allyn Holter System
Indications for Use
The Welch Allyn Holter System is intended for acquiring ambulatory ECG signals from
patients. Patients are people with coronary problems or people with suspected coronary
problems. This ambulatory electrocardiograph, and associated analysis system, can be
used on patients without any limitation on patient age or gender.
The Holter Recorder procedure is one of the many tools that clinicians use to capture
infrequent or activity provoked ECG rhythm abnormalities outside of the physician’s office.
Indications for conducting Holter recording are:
• Arrhythmias
• Chest pain
• Unexplained syncope
• Shortness of breath
• Palpitations
• Evaluation of a pacemaker
• Regulation of anti-arrhythmic drugs
• Evaluation of a patient after myocardial infarction
• Family history of heart disease
Contraindications
Computer assisted ECG data acquisition and interpretation is a valuable tool when used
properly. However, no automated interpretation is completely reliable and interpretations
should be reviewed by a qualified physician before treatment, or non-treatment, of any
patient.
The Welch Allyn Holter System is not intended for infants weighing less than 10 Kg
(22 lbs).
Using optional interpretive algorithms to generate measurements, data presentations,
graphical presentations, and interpretive statements on an advisory basis for patients.
WARNING Safety—Computer assisted ECG data acquisition and interpretation
is a valuable tool when used properly. However, no automated interpretation is
completely reliable and a qualified physician shall review the interpretations
before treatment, or non-treatment, of any patient.