Fluke ESA615 User Manual
ESA615
Electrical Safety Analyzer
Users Manual
FBC-0026
February 2012, Rev. 2, 2/13
© 2012, 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 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 2013, 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 1-440248-9300. 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 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.:
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 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.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 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 ESA615 Electrical Safety Analyzer is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
Table of Contents
Title Page
Introduction .................................................................................................................... 1
Intended Use .................................................................................................................. 3
Safety Information .......................................................................................................... 3
Unpack the Product ........................................................................................................ 5
Instrument Familiarization .............................................................................................. 6
How to Hold the Product ................................................................................................ 10
How to Connect to Line Power ....................................................................................... 10
How to Connect a DUT to the Product ........................................................................... 11
How to Turn On the Product ........................................................................................... 11
How to Access the Product Functions ............................................................................ 13
How to Connect a PC to the Product .............................................................................. 14
How to Set Up the Product ............................................................................................. 16
Set the Operator Name ............................................................................................. 16
Delete an Operator Name ......................................................................................... 17
Set the Date .............................................................................................................. 18
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Set the Time.............................................................................................................. 18
Set the Test Standard ............................................................................................... 18
Set the GFCI Limit .................................................................................................... 18
Set Polarity Switching Delay ..................................................................................... 19
Set the Date Format .................................................................................................. 19
Set the Time Format ................................................................................................. 19
Set the Language ...................................................................................................... 19
Set the Beeper .......................................................................................................... 20
Set the Display Contrast ........................................................................................... 20
How to View Instrument Information .............................................................................. 20
How to Do Electrical Safety Tests.................................................................................. 20
Set the Test Standard ............................................................................................... 21
Mains Voltage Test ................................................................................................... 21
Ground Wire (Protective Earth) Resistance Test ...................................................... 22
Insulation Resistance Test ........................................................................................ 27
Equipment Current Test ............................................................................................ 33
Leakage Current Test ............................................................................................... 33
Earth Leakage Current ......................................................................................... 34
Chassis (Enclosure) Leakage Test ...................................................................... 37
Lead-to-Ground (Patient) Leakage Test ............................................................... 39
Lead-to-Lead (Patient Auxiliary) Leakage Tests .................................................. 41
Lead Isolation (Mains on Applied Part) MAP Leakage Test ...................................... 43
Alternative Equipment Leakage Test ........................................................................ 46
Alternative Applied Part Leakage Test ...................................................................... 46
Direct Equipment Leakage Test ................................................................................ 48
Direct Applied Part Leakage Test ............................................................................. 50
Differential Leakage Current Test ............................................................................. 53
How to Use the 1-to-10 Adapter .................................................................................... 55
How to Do Point-To-Point Measurements ..................................................................... 59
ii
Contents (continued)
Measure Voltage ....................................................................................................... 59
Measure Resistance .................................................................................................. 59
Measure Current ........................................................................................................ 60
How to Simulate ECG Waveforms ................................................................................. 60
Memory .......................................................................................................................... 63
Test Sequences ............................................................................................................. 63
Factory Supplied Test Sequences ............................................................................. 63
How to Make a Test Sequence.................................................................................. 66
Make a New Test Sequence ................................................................................. 66
Make a Test Sequence from a Test Sequence in the Test Library ....................... 70
Edit a Test Sequence ................................................................................................ 70
Do a Test Sequence .................................................................................................. 71
Show Test Results ..................................................................................................... 72
Delete a Set of Test Results ...................................................................................... 73
Maintenance ................................................................................................................... 73
Fuse Test and Fuse Replacement ............................................................................. 73
How to Clean the Product .......................................................................................... 74
Replaceable Parts .......................................................................................................... 75
Accessories .................................................................................................................... 77
Specifications ................................................................................................................. 78
Detailed Specifications ................................................................................................... 79
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iv
List of Tables
Table Title Page
1. Symbols ................................................................................................................................. 2
2. Top-Panel Controls and Connections .................................................................................... 7
3. Side and Top-Panel Connections .......................................................................................... 9
4. Schematic Abbreviations ....................................................................................................... 25
5. Test Names Based on Selected Standard ............................................................................. 33
6. Factory Supplied Test Sequences ......................................................................................... 64
7. Test Settings for Test Sequences ......................................................................................... 68
8. Replaceable Parts ................................................................................................................. 75
9. Accessories ........................................................................................................................... 77
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vi
List of Figures
Figure Title Page
1. Front-Panel Controls and Connections ................................................................................. 6
2. Side and Top-Panel Connections .......................................................................................... 8
3. Product Handle ...................................................................................................................... 10
4. Product Ready for Operation ................................................................................................. 11
5. DUT Connections to the Product ........................................................................................... 12
6. Leakage Current Menu .......................................................................................................... 14
7. Product to PC Connection ..................................................................................................... 15
8. Setup Menu ........................................................................................................................... 16
9. Operator List Screen ............................................................................................................. 16
10. Mains Voltage Test Menu ...................................................................................................... 21
11. DUT Ground Resistance Measurement................................................................................. 23
12. Ground Wire (Protective Earth) Resistance Measurement Connections ............................... 24
13. Ground Wire (Protective Earth) Resistance Measurement Schematic .................................. 26
14. Insulation Resistance Measurement ..................................................................................... 27
15. Mains to Protective-Earth Insulation Resistance Test Schematic .......................................... 28
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16. Applied Parts to Protective-Earth Insulation Test Schematic ................................................ 29
17. Mains to Applied-Parts Insulation Test Schematic ................................................................ 30
18. Mains to Non-Earth Accessible Conductive Points Schematic ............................................. 31
19. Applied Parts to Non-Earth Conductive Points Schematic .................................................... 32
20. Leakage Current Main Menu ................................................................................................ 34
21. Earth Leakage Current Test Schematic ................................................................................ 36
22. Enclosure Leakage Current Test Schematic ......................................................................... 38
23. Lead-to-Ground (Patient) Leakage Current Test Schematic ................................................. 40
24. Applied Parts Connection Posts Display ............................................................................... 41
25. Lead-to-Lead (Patient Auxiliary) Leakage Current Test Schematic ...................................... 42
26. Lead Isolation (Mains On Applied Parts) Leakage Test Schematic ...................................... 45
27. Alternative Equipment Leakage Current Test Schematic ...................................................... 47
28. Alternative Applied Part Leakage Test Schematic ................................................................ 49
29. Direct Equipment Leakage Test Schematic .......................................................................... 51
30. Direct Applied Parts Leakage Current Test Schematic ......................................................... 52
31. Differential Leakage Current Test Schematic ....................................................................... 54
32. 1-to-10 Adapter Connections ................................................................................................ 56
33. ECG Lead Connection with 1-to-10 Adapter ......................................................................... 58
34. Point-To-Point Function Menu .............................................................................................. 59
35. ECG Waveform Simulation Menu ......................................................................................... 60
36. ECG Monitor Connections .................................................................................................... 62
37. Input Position ICON .............................................................................................................. 66
38. Test Sequence Screen ......................................................................................................... 71
39. Equipment Information Screen ............................................................................................. 71
40. Fuse Access ......................................................................................................................... 74
viii
Electrical Safety Analyzer
Introduction
Warning
To prevent possible electrical shock, fire, or
personal injury, read all “safety information”
before you use the Product.
The Fluke Biomedical ESA615 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) and international (IEC62353,
AN/NZS 3551, and parts of IEC 60601-1) electrical-safety
standards. The Product simulates ECG to do
performance tests on ECG monitors.
The integrated ANSI/AAMI ES1 and IEC60601-1 patient
loads are easily selectable.
The Product does these tests:
• Line (Mains) voltage
• Ground Wire (Protective Earth) resistance
• Equipment current
• Insulation resistance
• Ground (Earth) leakage
• Chassis (Enclosure) leakage
• Lead to Ground (Patient) and Lead to Lead (Patient
Auxiliary) leakage
• Lead isolation (Mains on applied parts leakage)
• Differential leakage
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• Direct equipment leakage
• Direct applied part leakage
• Alternative equipment leakage
• Alternative applied part patient leakage
• Point to point leakage, voltage, and resistance
• ECG simulation and performance waveforms
Table is a list of the symbols used on the Product and in
this manual.
Table 1. Symbols
Symbol Description
Important information. Refer to manual.
Hazardous voltage.
Conforms to relevant Canadian and US
standards.
Conforms to relevant Australian EMC
requirements.
Conforms to European Union directives.
Symbol Description
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:
CAT II
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. Go to Fluke’s website
for recycling information.
IEC Measurement Category II – CAT II
equipment designed to protect against
transients from energy-consuming
equipment supplied from fixed
installations.
Accessible Functional Earth Terminal.
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.
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.
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• Do not use test leads if they are
damaged. Examine the test leads for
damaged insulation, exposed metal, or if
the wear indicator shows. Check test
lead continuity.
• Examine the case before you use the
Product. Look for cracks or missing
plastic. Carefully look at the insulation
around the terminals.
• Make sure the ground conductor in the
mains power cord is connected to a
protective earth ground. Disruption of
the protective earth could put voltage on
the chassis that could cause death.
• Do not use an extension cord or adapter
plug.
• Do not use and disable the Product if it
is damaged.
• Do not use the Product around explosive
gas, vapor, or in damp or wet
environments.
• Do not touch voltages > 30 V ac rms, 42
V ac peak, or 60 V dc.
• Measure a known voltage first to make
sure that the Product operates correctly.
• Do not apply more than the rated
voltage, between the terminals or
between each terminal and earth ground.
• Remove the null post adapter from the
∅/Null jack after a test lead zero is
performed. The ∅/Null jack becomes
potentially hazardous during some of the
test conditions. Use only cables with
correct voltage ratings.
• Remove all probes, test leads, and
accessories that are not necessary for
the measurement.
• Keep fingers behind the finger guards on
the probes.
• Connect the common test lead before
the live test lead and remove the live test
lead before the common test lead.
• Use only current probes, test leads, and
adapters supplied with the Product.
• Do not use the 15-20 A adapter to supply
power to devices rated more than 15 A.
This can overload the installation.
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Electrical Safety Analyzer
Unpack the Product
• Replace the mains power cord if the
insulation is damaged or if the insulation
shows signs of wear.
• Comply with local and national safety
codes. Use personal protective
equipment (approved rubber gloves, face
protection, and flame-resistant clothes)
to prevent shock and arc blast injury
where hazardous live conductors are
exposed.
• Do not touch metal parts of the device
under test (DUT) while you do a test.
Some tests apply high voltage and high
current to the DUT with the DUT earth
connection open or closed.
Unpack the Product
Carefully unpack all items from the box and check that
you have these items:
• ESA615
• Getting Started Manual
• Users Manual CD
• Carrying case
• Power cord
• 15 – 20 A Adapter (USA only)
• ESA USA Accessory Kit (USA, Australia, and Israel
only) or ESA EUR Accessory Kit
• Ansur Demo CD
• Null Post Adapter
• 5-to-5 Banana to ECG Adapter (BJ2ECG)
• USB Transfer Cable
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ESA615
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Instrument Familiarization
Figure 1 and Table 2 show the front-panel controls and connections of the Product.
6
9
8
7
6
1
2
3
4
5
gtv116.eps
Figure 1. Front-Panel Controls and Connections
Electrical Safety Analyzer
Instrument Familiarization
Table 2. Top-Panel Controls and Connections
Item Name Description
Equipment Outlet
1
Configuration Buttons
2 High Voltage Indicator
3 Test Function Buttons Selects the Product test functions.
4 Navigation Buttons Cursor control buttons for navigating menus and lists.
5 Test Button Starts selected tests.
6 Enter Button Sets the highlighted function.
7 Input Jacks Test lead connectors.
8 Nulling Jack Connection to zero test lead resistance.
9 Function Softkeys
Controls the configuration of the equipment outlet. Opens and closes the neutral and
ground connection and reverses the polarity of the neutral and hot connection.
Illuminates when high voltage is applied to the ECG/Applied Parts posts or L1 and
L2 of the Test Receptacle.
Keys F1 through F4 are used to select from a number of selections that show in the
LCD display above each function softkey.
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Figure 2 and Table 3 describe the side and top-panel connections of the Product.
RA
R
LL LA
FL
RL
N
V1
C1
3
9
8
2
5
1
4
10
6
7
8
gtv110.eps
Figure 2. Side and Top-Panel Connections
Electrical Safety Analyzer
Instrument Familiarization
Table 3. Side and Top-Panel Connections
Item Name Description
1 Equipment Outlet
2 USB A Controller Port For external keyboard or barcode reader.
USB Device Port
3
(Mini B-style connector)
4 Fuse Access Door Equipment outlet fuse access.
5 Tilt Stand Holds the Product in a tilted position.
6 SD Card Slot SD Memory Card access
7 AC Power Switch Turns ac power on and off.
8 Power Input Connector
9 ECG/Applied Parts Jacks
10 Banana Jack to ECG Adapter Adapter to connect ECG snap leads to the Product.
Equipment outlet, specified to the version of the Product, which supplies a DUT
connection.
Digital connection to control the Product from a PC or instrument controller.
A grounded male three-prong (IEC 60320 C19) connector that accepts the
line-power cord.
Connection posts for Device Under Test (DUT) applied parts, such as ECG
leads. Used to test for leakage current through leads and to supply ECG
signals and performance waveforms to a DUT.
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How to Hold the Product
When you move the Product, use the handle on the
bottom case to hold it. See Figure .
Figure 3. Product Handle
gtv122.eps
How to Connect to Line Power
Warning
To prevent possible electrical shock, fire, or
personal injury:
• Do not use an extension cord or adapter
plug.
• Make sure the ground conductor in the
mains power cord is connected to a
protective earth ground. Disruption of
the protective earth could put voltage on
the chassis that could cause death.
• Replace the mains power cord if the
insulation is damaged or if the insulation
shows signs of wear.
• Use only the mains power cord and
connector approved for the voltage and
plug configuration in your country and
rated for the Product.
10
Electrical Safety Analyzer
How to Connect a DUT to the Product
The Product is intended for use with single-phase,
grounded power. It is not intended for dual, split-phase or
three-phase power configurations. It can be used with a
power system that supplies the correct voltages for
single-phase and is grounded, or is an isolated power
system.
Use the power cord for your country mains supply that is
not more than the voltage or power rating of the product.
Connect the cord into the power input connector and then
to the mains outlet.
How to Connect a DUT to the Product
You can connect a Device Under Test (DUT) a number of
different ways for a full electrical safety test. Figure
shows a DUT connected to the test receptacle, applied
parts posts, and a connection to the enclosure or
protective earth ground of the DUT.
Figure 4. Product Ready for Operation
gtv125.bmp
How to Turn On the Product
Note
To make sure the high voltage indicator works,
look for it to illuminate at the power-up.
Push the power switch found on the left-side panel so the
“I” side of the ac power switch is down. The Product does
a series of self tests and then shows the message in
Figure when the self test has completed successfully.
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Users Manual
Connect ESA615
to grounded
mains socket.
To protective earth or
any exposed conductive
surface on the enclosure
RA
R
LL
F
LA RL V1
L
NC1
Connect the DUT ac power cord to the
equipment outlet on the Analyzer
12
Figure 5. DUT Connections to the Product
gtv113.eps
Electrical Safety Analyzer
How to Access the Product Functions
The self-test measures the ac mains input for correct
polarity, ground integrity and voltage level. The high
voltage indicator illuminates briefly during the self test. If
the polarity is reversed, the Product shows this condition
and sets the polarity to be reversed internally. If the
ground is open, the Product shows this fault. If the mains
voltage is too high or too low, the Product shows this fault
and does not continue until the supply voltage is
corrected and the Product power turned off and then on
again.
How to Access the Product Functions
For each test and setup function, the Product uses a
series of menus to access different Product tests and
setup variables. The example shown in Figure , the
Product shows different leakage current tests along the
bottom of the display. A More softkey lets you access
more menus related to the test. When you push a softkey
(F1 through F4) below a test name, the Product sets up
for or does the selected test.
For some tests, it will be necessary to set parameters
with the navigation buttons. In the example above, the
leakage parameter has next to it. This icon shows you
must push or to set its value. In this example, the
leakage current measurement changes between AC+DC,
AC only, or DC only. The applied parts indicator has on
the left end and on the right end. These icons show that
you must push and to set an applied part.
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gtv102.bmp
Figure 6. Leakage Current Menu
The three buttons along the right side of the display
() control the wiring of the Product’s
test receptacle for some electrical tests. The current
condition of these three buttons is shown along the right
edge of the display when these controls are active.
Figure 5 shows polarity is settable between normal,
reversed, and off. Neutral is also settable to closed or
open. Earth condition is not shown, which means it can
not be changed. Earth is internally opened while the
Product does this test.
How to Connect a PC to the Product
To connect the Product to a PC:
Connect a USB port on your PC or laptop to the Mini B
USB device port on the Product.
Or
Plug in an XStick wireless USB dongle to your PC USB
port. Products available over wireless will be listed by
serial number. Connect to a single Product. See Figure 7.
14
Electrical Safety Analyzer
RA LL LA RL V1
RFLNC1
How to Connect a PC to the Product
RA LL LA RL
RF
L
N
V1
C1
gtv129.bmp
Figure 7. Product to PC Connection
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