Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of
original purchase OR two years if at the end of your first year you send the instrument to a Fluke Biomedical service center
for calibration. You will be charged our customary fee for such calibration. During the warranty period, we will repair or at our
option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to
Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the
product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized
Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE
EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration
of instruments is not covered under the warranty.
This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since
some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages,
this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or
other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.
7/07
Notices
All Rights Reserved
Copyright 2018, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translated into any language without the written permission of Fluke Biomedical.
Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service
training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to
Fluke Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking
the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking
instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or
broken parts, dents, or scratches.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call 1-800- 850-4608 or
1-440-248-9300. In Europe, email techsupport.emea@flukebiomedical.com or call +31-40-2965314.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing materials in
their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not
operate within specifications, or if there are any other problems not caused by shipping damage, please contact Fluke Biomedical or your local
sales representative.
Returns and Repairs
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an
instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that
you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are
received in damaged condition due to improper packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:
Use a double–walled carton of sufficient strength for the weight being shipped.
Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order
Entry Group at 1-440-498-2560.
Repair and calibration:
To find the nearest service center, go to www.flukebiomedical.com/service or
In the U.S.A. and Asia:
Cleveland Calibration Lab
Tel: 1-800-850-4608 x2564
Email: globalcal@flukebiomedical.com
To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedical recommends the product be calibrated at least
once every 12 months. Calibration must be done by qualified personnel. Contact your local Fluke Biomedical representative for
calibration.
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email: ServiceDesk@fluke.com
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was
shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for
which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper
operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the
information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical
for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.
Manufacturing Location
The ESA614 Electrical Safety Analyzer is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
To prevent possible electrical shock, fire, or
personal injury, read all safety information
before you use the Product.
The Fluke Biomedical ESA614 Electrical Safety Analyzer
(the Product) is a full-featured, compact, portable
analyzer, designed to verify the electrical safety of medical
devices. The Product tests to domestic (ANSI/AAMI ES1,
NFPA 99) electrical safety standards. The Product
simulates ECG to do performance tests on ECG monitors.
The Product does these tests:
• Line voltage
• Ground Wire resistance
• Equipment current
• Insulation resistance
• Ground leakage
• Chassis leakage
• Lead to Ground and Lead to Lead leakage
• Lead isolation
1
ESA614
Getting Started Manual
• Point to point leakage, voltage, and resistance
• ECG simulation and performance waveforms
Table 1 is a list of the symbols used on the Product and in
this manual.
Table 1. Symbols
Symbol Description
W WARNING. RISK OF DANGER.
X
WARNING. HAZARDOUS VOLTAGE.
Risk of electric shock.
Consult user documentation.
Fuse
˜Equipotential
Measurement Category II is applicable to
test and measuring circuits connected
directly to utilization points (socket
outlets and similar points) of the lowvoltage MAINS installation.
Symbol Description
P Conforms to European Union directives.
)
~
Certified by CSA Group to North
American safety standards.
Conforms to relevant Australian EMC
requirements.
Conforms to relevant South Korean EMC
Standards.
This product complies with the WEEE
Directive marking requirements. The
affixed label indicates that you must not
discard this electrical/electronic product
in domestic household waste. Product
Category: With reference to the
equipment types in the WEEE Directive
Annex I, this product is classed as
category 9 "Monitoring and Control
Instrumentation" product. Do not dispose
of this product as unsorted municipal
waste.
2
Electrical Safety Analyzer
Intended Use
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:
• Carefully read all instructions.
• 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 apply more than the rated voltage,
between the terminals or between each
terminal and earth ground.
•Measure a known voltage first to make
sure that the Product operates correctly.
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