Safety Information; Intended Use - Fluke ESA615 User Manual

Intended Use

The Product is an electronic signal source and
measurement device for verifying the electrical safety of
medical devices. The Product also provides ECG
simulation and performance waveforms to verify patient
monitors are performing within their operating
specifications.
The Product provides the following function categories:
•
ECG Functions
•
ECG-Performance Testing
The intended user is a trained biomedical equipment
technician who performs periodic preventative
maintenance checks on patient monitors 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.

Safety Information

In this manual, a Warning identifies conditions and
procedures that are dangerous to the user. A Caution
identifies conditions and procedures that can cause
damage to the Product or the equipment under test.
XW Warning
To prevent possible electrical shock, fire, or
personal injury, follow these guidelines:
•
Use the Product only as specified, or the
protection supplied by the Product can
be compromised.
•
Use only the mains power cord and
connector approved for the voltage and
plug configuration in your country and
rated for the Product.
•
Do not connect the Product to a patient
or equipment connected to a patient. The
Product is intended for equipment
evaluation only. The Product must not be
used in diagnostics, treatment, or other
capacities where the Product could
touch a patient.
Electrical Safety Analyzer
Intended Use
3