Introduction; Intended Use - Fluke ESA609 User Manual

Introduction

The Fluke Biomedical ESA609 Electrical Safety Analyzer
(the Analyzer) is a full-featured, compact, portable
analyzer that verifies the electrical safety of medical
devices. The Analyzer tests to domestic (ANSI/AAMI ES1,
NFPA 99) and international (and parts of IEC 62353 and
IEC 60601-1) electrical-safety standards. The integrated
ANSI/AAMI ES1 and IEC 60601-1 patient loads are easy
to select.
The Analyzer does the following tests:
•
Line (Mains) voltage
•
Ground Wire (or Protective Earth) Resistance
•
Equipment current
•
Ground Wire (Earth) leakage
• Chassis (Enclosure) leakage
•
Direct equipment leakage
•
Point to point leakage and resistance
Electrical Safety Analyzer

Intended Use

The Product is an electronic signal source and
measurement device for verifying the electrical safety of
medical devices.
The intended user is a trained biomedical equipment
technician who performs periodic preventative
maintenance checks on medical equipment in service.
Users can be associated with hospitals, clinics, original
equipment manufacturers and independent service
companies that repair and service medical equipment. The
end user is an individual, trained in medical
instrumentation technology.
This Product is intended to be used in the laboratory
environment, outside of the patient care area, and is not
intended for use on patients, or to test devices while
connected to patients. This Product is not intended to be
used to calibrate medical equipment. It is intended for
over-the-counter use.
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