Spacelabs Healthcare 98000, Operation Manual

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070-2567-03 Rev. A
1-1
1. Introduction
1.1 Intended Use
The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of
ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting
certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis
results, and construct a report for physician use.
The Spacelabs Pathfinder SL Holter Analyzer is intended for use on adult patients only as a
screening device to determine the need for clinical diagnosis and evaluation by polysomnography
based on the patient’s score. The EGG recording may be obtained at any location specified by
a physician including home, hospital or clinic. Subjects screened for sleep apnea should have
periods of sleep of at least 4 hours duration during which the EGG is predominantly sinus rhythm
in nature.
1.2 Safety and Regulatory Information
This product is in conformity with the essential requirements and provisions of Council
Directive 93/42/EEC concerning medical devices.
US Federal law restricts the devices documented herein to sale by, or on the order of,
a physician.
Consult Documents
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This product must be sent to separate collection facilities for recovery and recycling.