Fluke ESA612 User Manual

ESA612

Electrical Safety Analyzer

Users Manual

March 2009, Rev. 1
© 2009 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. 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

Contents (continued)

Notices

All Rights Reserved

© Copyright 2008, 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 [e-mail] or call 1-800- 648-7952 or 1-425­446-6945.

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.

Standard Terms and Conditions

Refunds and Credits

Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number tag) are
eligible for partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases, auxiliary modules, etc.)
are not eligible for retu rn or refund. Only products returned within 90 days from the date of original purchase are eligible for refund/credit. In
order to receive a partial refund/credit of a product purchase price on a serialized product, the product must not have been damaged by the
customer or by the carrier chosen by the customer to return the goods, and the product must be returned complete (meaning with all manuals,
cables, accessories, etc.) and in “as new” and resalable condition. Products not returned within 90 days of purchase, or products which are not
in “as new” and resalable condition, are not eligible for credit return and will be returned to the customer. The Return Procedure (see below)
must be followed to assure prompt refund/credit.

Restocking Charges

Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 %. Products returned in excess
of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20 %. Additional charges for damage and/or
missing parts and accessories will be applied to all returns.

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.

Contents (continued)

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 1-800-648-7952 or 1-425-446-6945.

Repair and calibration:

To find the nearest service center, go to www.flukebiomedical.com/service

In the U.S.A.:
Cleveland Calibration Lab
Tel: [phone]
Email: [e-mail]

Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: [e-mail]

In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: [phone]
Email: [e-mail]

In Asia:
Everett Calibration Lab
Tel: [phone]
Email: [e-mail]

or

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 ESA612 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 .......................................................................................................... 2

Intended Use.................................................................................................................. 3

Unpacking the Analyzer ................................................................................................. 4

Instrument Familiarization .............................................................................................. 4

Connecting to Line Power .............................................................................................. 8

Connecting a DUT to the Analyzer ................................................................................. 8

Turning the Analyzer On ................................................................................................ 8

Accessing the Analyzer’s Functions............................................................................... 10

Setting Up the Analyzer.................................................................................................. 11

Setting Polarity Switching Delay................................................................................ 11

Setting the Display Contrast ...................................................................................... 11

Setting up the Beeper................................................................................................ 12

Viewing Instrument Information ................................................................................. 12

Viewing Memory........................................................................................................ 12

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Setting the GFCI Limit............................................................................................... 12

Performing Electrical Safety Tests................................................................................. 12

Setting the Test Standard ......................................................................................... 13

Performing Mains Voltage Testing ............................................................................ 13

Performing a Ground Wire (Protective Earth) Resistance Test................................. 13

Performing an Insulation Resistance Test ................................................................ 19

Performing a Current Consumption Test .................................................................. 25

Performing Leakage Current Tests ........................................................................... 25

Measuring Earth Leakage Current ....................................................................... 26

Performing a Chassis (Enclosure) Leakage Test ................................................. 29

Performing a Lead-to-Ground (Patient) Leakage Test ......................................... 31

Performing Lead-to-Lead (Patient Auxiliary) Leakage Tests................................ 33

Performing a Lead Isolation (Mains on Applied Part) Leakage Test ......................... 35

Performing an Alternative Equipment Leakage Test................................................. 37

Performing an Alternative Applied Part Leakage Test .............................................. 37

Performing a Direct Equipment Leakage Test .......................................................... 39

Performing a Direct Applied Part Leakage Test ........................................................ 41

Performing a Differential Leakage Current Test........................................................ 44

Using the 1210 Adapter ................................................................................................. 46

Making Point-To-Point Measurements........................................................................... 50

Measuring Voltage .................................................................................................... 50

Measuring Resistance .............................................................................................. 50

Measuring Current .................................................................................................... 51

Simulating ECG Waveforms .......................................................................................... 51

Using Memory ............................................................................................................... 54

Storing Data into Memory ......................................................................................... 54

Viewing Memory Data............................................................................................... 55

Deleting Data from Memory ...................................................................................... 55

Controlling the Analyzer Remotely................................................................................. 55

ii

Contents (continued)

Maintenance................................................................................................................... 56

Testing and Replacing the Fuses ................................................................................... 56

Cleaning the Analyzer .................................................................................................... 57

Replaceable Parts.......................................................................................................... 58

Accessories.................................................................................................................... 60

Specifications ................................................................................................................. 61

Detailed Specifications ................................................................................................... 62

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iv

List of Tables

Table Title Page

1. Symbols................................................................................................................................. 2

2. Top-Panel Controls and Connections.................................................................................... 5

3. Side and Top-Panel Connections.......................................................................................... 7

4. Schematic Abbreviations....................................................................................................... 17

5. Test Names Based on Selected Standard............................................................................. 25

6. Replaceable Parts ................................................................................................................. 58

7. Accessories ........................................................................................................................... 60

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vi

List of Figures

Figure Title Page

1. Front-Panel Controls and Connections ................................................................................. 4

2. Side and Top-Panel Connections.......................................................................................... 6

3. Analyzer Ready for Operation ............................................................................................... 8

4. DUT Connections to the Analyzer ......................................................................................... 9

5. Leakage Current Menu.......................................................................................................... 10

6. Setup Menu ........................................................................................................................... 11

7. Mains Voltage Test Menu...................................................................................................... 13

8. DUT Ground Resistance Measurement................................................................................. 14

9. Ground Wire (Protective Earth) Resistance Measurement Connections............................... 16

10. Ground Wire (Protective Earth) Resistance Measurement Schematic .................................. 18

11. Insulation Resistance Measurement ..................................................................................... 19

12. Mains to Protective-Earth Insulation Resistance Test Schematic.......................................... 20

13. Applied Parts to Protective-Earth Insulation Test Schematic................................................. 21

14. Mains to Applied Parts Insulation Test Schematic................................................................. 22

15. Mains to Non-Earth Accessible Conductive Points Schematic .............................................. 23

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16. Applied Parts to Non-Earth Conductive Points Schematic.................................................... 24

17. Leakage Current Main Menu ................................................................................................ 26

18. Earth Leakage Current Test Schematic ................................................................................ 28

19. Enclosure Leakage Current Test Schematic......................................................................... 30

20. Lead-to-Ground (Patient) Leakage Current Test Schematic................................................. 32

21. Applied Parts Connection Posts Display............................................................................... 33

22. Lead-to-Lead (Patient Auxiliary) Leakage Current Test Schematic ...................................... 34

23. Lead Isolation (Mains On Applied Parts) Leakage Test Schematic ...................................... 36

24. Alternative Equipment Leakage Current Test Schematic...................................................... 38

25. Alternative Applied Part Leakage Test Schematic ................................................................ 40

26. Direct Equipment Leakage Test Schematic .......................................................................... 42

27. Direct Applied Parts Leakage Current Test Schematic ......................................................... 43

28. Differential Leakage Current Test Schematic ....................................................................... 45

29. 1210 Adapter Connections ................................................................................................... 47

30. EGC Lead Connection with 1210 Adapter ............................................................................ 49

31. Point-To-Point Function Menu .............................................................................................. 50

32. ECG Waveform Simulation Menu ......................................................................................... 51

33. ECG Monitor Connections .................................................................................................... 53

34. Test Record ID Entry Screen................................................................................................ 54

35. Fuse Access ......................................................................................................................... 57

viii

Electrical Safety Analyzer

Introduction

The Fluke Biomedical ESA612 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 domestic
(ANSI/AAMI ES1, NFPA 99) and international (IEC62353,
AN/NZS 3551, and parts of IEC 60601-1) electrical-safety
standards. The integrated ANSI/AAMI ES1 and
IEC60601-1 patient loads are easily selectable.

The Analyzer performs the following tests:

• Line (Mains) voltage

• Ground Wire (or 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

• 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

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Table 1. Symbols

Symbol Description

W
X

)

;

Important information; refer to manual.

Hazardous voltage

Conforms to relevant Canadian and US
standards

Conforms to relevant Australian EMC
requirements

P Conforms to European Union directives

Do not dispose of this product as

~

CAT II

˜

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

Safety Information

In this manual, a Warning identifies hazardous conditions
and actions that could cause bodily harm or death. A
Caution identifies conditions and actions that could
damage the Analyzer, the equipment under test, or cause
permanent loss of data.

XW 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 or damp

locations, around explosive gases or dust.

2

Electrical Safety Analyzer

Intended Use

• 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.

• 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.

• Do not use the 15-20 A adapter to power

devices rated in excess of 15 A. Doing so
may overload the installation.

• Use extreme caution when working with

voltages above 30 V.

• 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.

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Unpacking the Analyzer

Carefully unpack all items from the box and check that
you have the following items:

• ESA612

• 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)

• ESA EUR Accessory Kit

• Ansur demo CD

• Null Post Adapter

• 5-to-5 Banana to ECG Adapter (BJ2ECG)

• Transfer cable

Instrument Familiarization

Figure 1 and Table 2 describes the front-panel controls
and connections of the Analyzer.

1

9

2

8

TEST

7

Figure 1. Front-Panel Controls and Connections

3

4

5

6

fis116.eps

4

Electrical Safety Analyzer

Instrument Familiarization

Table 2. Top-Panel Controls and Connections

Item Name Description

Controls the configuration of

Equipment Outlet
Configuration

1

Buttons

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

High Voltage

2

Indicator

is applied to the
ECG/Applied Parts posts or
L1 and L2 of the Test
Receptacle.

Item Name Description

Nulling Jack

8

Connection for zeroing test
lead resistance.

Keys F1 through F4 are used
to select from a number of

Function Softkeys

9

selections that appear in the
LCD display above each
function softkey.

Test Function

3

Buttons

Navigation Buttons

4

Test Button

5

Save Button

6

Input Jacks

7

Selects the various Analyzer
test functions.

Cursor control buttons for
navigating menus and lists.

Initiates selected tests.

Saves the measurement or
ECG waveform to memory.

Test lead connectors.

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Figure 2 and Table 3 describe the side and top-panel connections of the Analyzer.

RA LL LA RL V1

R

FLN

C1

6

TEST

7

2

4

1

3

8

5

6

fis110.eps

Figure 2. Side and Top-Panel Connections

Electrical Safety Analyzer

Instrument Familiarization

Table 3. Side and Top-Panel Connections

Item Name Description

Equipment Outlet

1

USB Device Port

2

(B-style connector)

3 Fuse Access Door Covers the equipment outlet fuses.

4 Tilt Stand Support for holding the Analyzer in a tilted position.

5 AC Power Switch Turns ac power on and off.

6 Power Input Connector

7 ECG/Applied Parts Jacks

8 Banana Jack to ECG Adapter Adapter for connecting ECG snap leads to the Analyzer.

Equipment outlet, specific to the version of the Analyzer, which provides a DUT
connection.

Digital connection for controlling the Analyzer 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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Connecting to Line Power

XWWarning

To avoid shock hazard and for proper
Analyzer operation, connect the factory
supplied three-conductor line power cord to
a properly grounded power outlet. Do not
use a two-conductor adapter or extension
cord; this will break the protective ground
connection.

Connect the Analyzer to a properly grounded three-prong
outlet. The Analyzer will not properly test a DUT when the
ground lead is open.

The Analyzer is intended for use with single-phase,
grounded power. It is not intended for dual, split-phase or
three-phase power configurations. But it can be used with
any power system that supplies the correct voltages for
single-phase and is grounded, or is an isolated power
system.

Connecting a DUT to the Analyzer

A Device Under Test (DUT) can be connected in a
number of different ways depending on the device and
the number of connections needed for a full electrical
safety test. Figure 4 shows a DUT connected to the test
receptacle, applied parts posts, and a separate
connection to the DUT’s enclosure or protective earth
ground.

Turning the Analyzer On

Note

To ensure the high voltage indicator is working,
look for it to illuminate during the power-up self
test.

Press the power switch on the left-side panel so the “I”
side of the ac power switch is depressed. The Analyzer
will perform a series of self tests and then display the
message shown in Figure 3 when the self test has
completed successfully.

fis101.jpg

Figure 3. Analyzer Ready for Operation

8

Electrical Safety Analyzer

Turning the Analyzer On

To protective earth or any exposed

conductive surface on the enclosure

RA LL LA

R

F

L

RL

NC1

V1

TEST

Figure 4. DUT Connections to the Analyzer

fis113.eps

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During the self-test, the Analyzer checks its ac mains
input for proper polarity, ground integrity and voltage
level. The high voltage indicator illuminates briefly during
the self test. If the polarity is reversed, the Analyzer
indicates this condition and allows the polarity to be
reversed internally. If the ground is open, the Analyzer
displays this fault. If the mains voltage is too high or too
low, the Analyzer displays this fault and does not continue
until the supply voltage is corrected and the Analyzer
power cycled off and then on again.

Accessing the Analyzer’s Functions

For each test and setup function, the Analyzer uses a
series of menus to access various Analyzer test and
setup variables. As shown in Figure 5, the Analyzer
indicates various leakage current tests along the bottom
of the display. An Exit selection is also indicated as a way
of backing out of the leakage current tests. Pressing a
softkey (F1 through F4) under a specific test will cause
the analyzer to setup for or perform the selected test.

In addition to the function softkeys, the Analyzer test
functions may require using the navigation buttons to
select parameters as well. In the example above, the
leakage selection has K next to it. This icon indicates the
selection is controlled by pressing G or H. In this
example, the leakage current measurement is switched
between AC+DC, AC only, or DC only. The applied parts
indicator has W on the left end and X on the right end.

These icons indicate the use of E and F to select an
applied part.

fis102.jpg

Figure 5. Leakage Current Menu

The three buttons along the right side of the display
(PND) control the wiring of the Analyzer’s
test receptacle for some electrical tests. The present state
of these three buttons is displayed along the right edge of
the display whenever 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 displayed, which indicates it
can not be changed. However, earth is internally opened
during this test.

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