Welch Allyn Holter System - User Manual - Manual (Page 5)

Directions for Use 1
Directions for Use
Intended Use
The Welch Allyn Holter System is intended to be used as a Holter ambulatory
electrocardiograph system for the purpose of screening for ECG rhythm disturbances up
to a 48-hour period. The Welch Allyn Holter System is intended for use under the
supervision of a physician or those knowledgeable in all aspects of ECG morphology,
rhythm, and arrhythmia.
This procedure is known as a Holter procedure and captures infrequent or activity
provoked ECG rhythm abnormalities outside of the physician’s office.
The Welch Allyn Holter System is comprised of the Welch Allyn Holter Recorder and the
Welch Allyn Holter System Application.
As the patient wears the recorder component of the system, it records ambulatory
electrocardiograph data. The Welch Allyn Holter System Application analyzes the recorder
data.
The Welch Allyn Holter System is not intended for infants weighing less than 10 Kg
(22 lbs).
The Welch Allyn Holter System acquires ambulatory ECG waveforms from patients.
The recorder and associated accessories provide signal acquisition for up to three
channels (HR100 and HR300) or up to eight channels (HR1200) of patient ECG waveforms
through surface electrodes adhered to the body.
The subject devices provide the following diagnostic functions:
• Acquire, view, store, and print ambulatory ECG waveforms from patients.
The recorder and associated accessories provide signal acquisition for up to 12 leads
of patient ECG waveforms through surface electrodes adhered to the patient.
• Using optional Holter algorithms to generate measurements, data presentations and
graphical presentations on an advisory basis for patients. These are presented for
review and interpretation by the clinician based upon knowledge of the patient, the
results of the physical examination, the ambulatory ECG data full disclosure displays,
and other clinical findings.
• Using optional interpretive algorithms to generate measurements, data
presentations, graphical presentations, and interpretive statements on an advisory
basis for patients. These are presented for review and interpretation by the clinician
based upon knowledge of the patient, the results of the physical examination, the
ambulatory ECG data full disclosure displays, and other clinical findings.
Caution US Federal law restricts this device to sale by or on the order of a
physician.