Fluke ESA620 User Manual
ESA620
Electrical Safety Analyzer
Users Manual
FBC-0028
January 2008, Rev. 2, 3/13
© 2008, 2013 Fluke Corporation. All rights reserved. Specifications are subject to change without notice.
All product names are trademarks of their respective companies.
Warranty and Product Support
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 prepa id, to
Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. T he 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 consequ ential 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 2008, 2013, Fluke Biomedical. No part of this publicat ion 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 distribution s, submit a w ritten 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 unp acking
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 1-440248-9300. In Europe, email techsupport.emea@flukebiomedical.com or call +31-40-2675314.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all pa cking 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 freigh t-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 B iomedical will not be responsible for lo st shipments or in struments 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 follow ing 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.:
Cleveland Calibration Lab
Tel: 1-800-850-4608 x2564
Email: globalcal@flukebiomedical.com
Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: service.status@fluke.com
To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedica l recommends the product be calibrated a t least once
every 12 months. Calibration must be done by qualified personnel. Contact your local Fluke Biomedica l representative for calibration.
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email: servicedesk@fluke.nl
In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: service.international@fluke.com
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomed ical’s manufacturing specifications when it w as
shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and T echnology (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 ele ctrical 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 ESA620 Electrical Safety Analyzer is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
Table of Contents
Title Page
Introduction .................................................................................................................... 1
Safety Information .......................................................................................................... 3
Intended Use .................................................................................................................. 4
Unpacking the Analyzer ................................................................................................. 5
Instrument Familiarization .............................................................................................. 6
Connecting to Line Power .............................................................................................. 10
Connecting a DUT to the Analyzer ................................................................................. 10
Turning the Analyzer On ................................................................................................ 10
Accessing the Analyzer’s Functions ............................................................................... 12
Setting Up the Analyzer .................................................................................................. 12
Selecting 2-Wire or 4-Wire Measurements ................................................................ 13
Setting the Default Measurement Current ................................................................. 13
Setting Polarity Switching Delay ................................................................................ 16
Setting the Display Contrast ...................................................................................... 16
Setting up the Beeper ................................................................................................ 16
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Performing Electrical Safety Tests ................................................................................. 17
Setting the Test Standard ......................................................................................... 17
Performing an Accessible Voltage Test (IEC 61010 only) ........................................ 17
Performing Mains Voltage Testing ............................................................................ 18
Performing a Protective Earth Resistance Test ........................................................ 18
Performing an Insulation Resistance Test ................................................................ 23
Performing a Current Consumption Test .................................................................. 29
Performing Leakage Current Tests ........................................................................... 29
Measuring Earth Leakage Current ....................................................................... 30
Performing an Enclosure Leakage Test ............................................................... 32
Performing a Patient Leakage Test ...................................................................... 34
Performing Patient Auxiliary Leakage Tests ......................................................... 36
Performing a Mains on Applied Part Leakage Test ................................................... 38
Performing an Alternative Equipment Leakage Test ................................................. 40
Performing an Alternative Applied Part Leakage Test .............................................. 40
Performing a Direct Equipment Leakage Test .......................................................... 43
Performing a Direct Applied Part Leakage Test ........................................................ 45
Performing a Differential Leakage Current Test ........................................................ 47
Performing an Accessible Leakage Current Test (IEC 61010 only) .......................... 47
Making Point-To-Point Measurements ........................................................................... 49
Measuring Voltage .................................................................................................... 49
Measuring Resistance .............................................................................................. 49
Measuring Current .................................................................................................... 50
Simulating ECG Waveforms .......................................................................................... 50
Controlling the Analyzer Remotely................................................................................. 52
Maintenance .................................................................................................................. 52
Cleaning the Analyzer .................................................................................................... 53
Replaceable Parts ......................................................................................................... 54
Accessories ................................................................................................................... 56
ii
Contents (continued)
Specifications ................................................................................................................. 57
Detailed Specifications ................................................................................................... 58
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iv
List of Tables
Table Title Page
1. Symbols ................................................................................................................................. 2
2. Top-Panel Controls and Connections .................................................................................... 7
3. Rear-Panel Connections ....................................................................................................... 9
4. Schematic Abbreviations ....................................................................................................... 21
5. Test Names Based on Selected Standard ............................................................................. 29
6. Replaceable Parts ................................................................................................................. 54
7. Accessories ........................................................................................................................... 56
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vi
List of Figures
Figure Title Page
1. Top-Panel Controls and Connections .................................................................................... 6
2. Rear-Panel Connections ....................................................................................................... 8
3. Analyzer Ready for Operation ............................................................................................... 10
4. DUT Connections to the Analyzer ......................................................................................... 11
5. Leakage Current Menu .......................................................................................................... 12
6. Setup Menu ........................................................................................................................... 13
7. 2-Wire Earth Resistance Measurement Connections ............................................................ 14
8. 4-Wire Earth Resistance Measurement Connection .............................................................. 15
9. Mains Voltage Test Menu ...................................................................................................... 18
10. DUT Ground Resistance Measurement................................................................................. 20
11. Protective-Earth Resistance Measurement Schematic ......................................................... 22
12. Insulation Resistance Measurement ..................................................................................... 23
13. Mains to Protective-Earth Insulation Resistance Test Schematic .......................................... 24
14. Applied Parts to Protective-Earth Insulation Test Schematic ................................................. 25
15. Mains to Applied Parts Insulation Test Schematic ................................................................. 26
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16. Mains to Non-Earth Accessible Conductive Points Schematic ............................................. 27
17. Applied Parts to Non-Earth Conductive Points Schematic .................................................... 28
18. Leakage Current Main Menu ................................................................................................ 30
19. Earth Leakage Current Test Schematic ................................................................................ 31
20. Enclosure Leakage Current Test Schematic ......................................................................... 33
21. Patient Leakage Current Test Schematic ............................................................................. 35
22. Applied Parts Connection Posts Display ............................................................................... 36
23. Patient Auxiliary Leakage Current Test Schematic ............................................................... 37
24. Mains-On-Applied-Parts-Leakage-Current Test Schematic .................................................. 39
25. Alternative Equipment Leakage Current Test Schematic ...................................................... 41
26. Alternative Applied Part Leakage Test Schematic ................................................................ 42
27. Direct Equipment Leakage Test Schematic .......................................................................... 44
28. Direct Applied Parts Leakage Current Test Schematic ......................................................... 46
29. Differential Leakage Current Test Schematic ....................................................................... 48
30. Point-To-Point Function Menu .............................................................................................. 49
31. ECG Waveform Simulation Menu ......................................................................................... 50
32. ECG Monitor Connections .................................................................................................... 51
viii
Electrical Safety Analyzer
Introduction
The Fluke Biomedical ESA620 Electrical Safety Analyzer
(hereafter the Analyzer) is a full-featured, compact,
portable analyzer, designed to verify the electrical safety
of medical devices. The Analyzer tests to international
(IEC 60601-1, EN62353, AN/NZS 3551, IEC61010, VDE
751) and domestic (ANSI/AAMI ES1, NFPA 99) electricalsafety standards. The integrated ANSI/AAMI ES1,
IEC60601-1, and IEC61010 patient loads are easily
selectable.
The Analyzer performs the following tests:
• Mains (Line) voltage
• Protective Earth (or Ground Wire) Resistance
• Equipment current
• Insulation resistance
• Earth (Ground) leakage
• Enclosure (Chassis) leakage
• Patient (Lead to Ground) and patient auxiliary
(Lead to Lead) leakage
• Mains on applied parts leakage (Lead isolation)
• Differential leakage
• Direct equipment leakage
• Direct applied part leakage
• Alternative equipment leakage
• Alternative applied part patient leakage
• Accessible part leakage
• Accessible part voltage
• Point to point leakage, voltage, and resistance
• ECG simulation and performance waveforms
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Table 1. Symbols
Symbol Description
Risk of Danger. Important information. See Manual.
Hazardous voltage. Risk of electric shock.
Conforms to relevant North American Safety Standards.
Conforms to relevant Australian EMC standards
Conforms to European Union directives
This product complies with the WEEE Directive (2002/96/EC) 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 prod uct as unsorted
municipal waste. Go to Fluke’s website for recycling information.
2
CAT II
Measurement Category II is applicable to test and measuring circuits connected directly to utilization points
(socket outlets and similar points) of the low-voltage MAINS installation.
Accessible Functional Earth Terminal
Electrical Safety Analyzer
Safety Information
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.
Warning
To avoid possible electrical shock or
personal injury, follow these guidelines:
• Use this Analyzer only in the manner
specified by the manufacturer or the
protection provided may be impaired.
• Read the Users Manual before operating
the Analyzer.
• Do not connect the Analyzer to a patient
or equipment connected to a patient. The
Analyzer is intended for equipment
evaluation only and should never be
used in diagnostics, treatment or in any
other capacity where the Analyzer would
come in contact with a patient.
• Do not use the product in wet locations,
around explosive gases or dust.
• Inspect the Analyzer before using it. Do
not use the Analyzer if abnormal
conditions of any sort are noted (such as
a faulty display, broken case, etc.)
• Inspect the test leads for damaged
insulation or exposed metal. Check test
lead continuity. Replace damaged leads
before using the Analyzer.
• When testing, always be sure to keep
your fingers behind the safety barriers
on the test leads.
• Never open the Analyzer's case.
Dangerous voltages are present. There
are no user replaceable parts in the
Analyzer.
• Have the Analyzer serviced only by
qualified personnel.
• Do not use the 15-20A adapter to power
devices rated in excess of 15A. Doing so
may overload the installation.
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• The Analyzer must be properly earthed.
Only use a supply socket that has a
protective earth contact. If there is any
doubt as to the effectiveness of the
supply socket earth, do not connect the
Analyzer. Do not use a two-conductor
adapter or extension cord; this will break
the protective ground connection.
• Use extreme caution when working with
voltages above 30 volts.
• Use the proper terminals, functions and
ranges for the test being performed.
• Do not touch metal parts of the device
under test (DUT) during analysis. The
DUT should be considered an electrical
shock hazard when connected to the
Analyzer as some tests involve high
voltages, high currents, and/or the
removal of DUT earth bond.
Intended Use
The Analyzer is intended for use by trained service
technicians to perform periodic inspections on a wide
range of medical equipment. The testing procedures are
menu-driven, and simple to operate.
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.
4
Electrical Safety Analyzer
Unpacking the Analyzer
Unpacking the Analyzer
Carefully unpack all items from the box and check that
you have the following items:
• ESA620
• Getting Started Manual
• Users Manual CD
• Carrying case
• Power cord
• 15 – 20 A Adapter (USA only)
• Test lead set
• TP1 Test probe set (USA, Australia, and Israel only)
• TP74 Test probe set (Europe only)
• Ansur demo CD
• Alligator clip set
• Null post adapter
• Data transfer cable
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ESA620
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Instrument Familiarization
Figure 1 and Table 2 describes the top-panel controls and connections of the Analyzer.
1
RA LL LA RL V1 V2 V3 V4 V5 V6R F L N C1 C2 C3 C4 C5 C6
10
2
3
6
230 VAC
ELECTRICAL SAFETY ANALYZER
ESA620
M
POINT TO
POINT
STANDARDS
SETUP
F1 F2 F3 F4 F5
POLARITY
NEUTRAL
EARTH
TEST
9
8
7
6
4
5
faw02.eps
Figure 1. Top-Panel Controls and Connections
Electrical Safety Analyzer
Instrument Familiarization
Table 2. Top-Panel Controls and Connections
Item Name Description
ECG/Applied Parts
1
Posts
Nulling Jack
2
Equipment Outlet
3
Navigation Buttons
4
Test Button
5
Equipment Outlet
Configuration
6
Buttons
High Voltage
7
Indicator
Function Softkeys
8
Test Function
9
Buttons
Input Jacks
10
Connection posts for Device Under Test (DUT) leads, like ECG leads. Used to test for
leakage current through leads and to supply ECG signals and performance waveforms to a
DUT.
Connection for zeroing test lead resistance. Use the probe attached to the test lead to put
into the null jack. Use the null post adapter when you use the alligator clip attached to the
test lead.
Equipment outlet, specific to the version of the Analyzer, which provides a DUT connection.
Cursor control buttons for navigating menus and lists.
Initiates selected tests.
Controls the wiring of the equipment outlet. Opens and closes the neutral and ground
connection and reverses the polarity of the neutral and hot connection.
Indicates when high voltage is applied to the ECG/Applied Parts posts or L1 and L2 of the
Test Receptacle.
Keys F1 through F5 are used to select from a number of selections that appear in the LCD
display above each function softkey.
Selects the various Analyzer test functions.
Test lead connectors.
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Figure 2 and Table 3 describe the rear-panel connections of the Analyzer.
8
1
2
43
faw01.eps
Figure 2. Rear-Panel Connections
Electrical Safety Analyzer
Instrument Familiarization
Table 3. Rear-Panel Connections
Item Name Description
1 AC Power Switch Turns ac power on and off
2 AC Power Input Connector
3 Line Power Fuse Holders The line power fuses.
USB Device Port (B-style
4
connector)
A grounded male three-prong (IEC 320 C20) connector that accepts the
line-power cord.
Digital connection for controlling the Analyzer from a PC or instrument
controller.
9
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