0% found this document useful (0 votes)
228 views78 pages

Fluke ESA612

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
228 views78 pages

Fluke ESA612

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 78

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 [email protected] or call 1-800- 648-7952 or 1-425-
446-6945.

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 return 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:
ƒ Use a double–walled carton of sufficient strength for the weight being shipped.
ƒ Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.
ƒ 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 or

In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4606
Email: [email protected]

Everett Calibration Lab


Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: [email protected]

In Europe, Middle East, and Africa:


Eindhoven Calibration Lab
Tel: +31-402-675300
Email: [email protected]

In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: [email protected]

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

i
ESA612
Users Manual
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

iii
ESA612
Users Manual

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

v
ESA612
Users Manual

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

vii
ESA612
Users Manual
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 • Insulation resistance


• Ground (Earth) leakage
The Fluke Biomedical ESA612 Electrical Safety Analyzer
(hereafter the Analyzer) is a full-featured, compact, • Chassis (Enclosure) leakage
portable analyzer, designed to verify the electrical safety • Lead to Ground (Patient) and Lead to Lead (Patient
of medical devices. The Analyzer tests to domestic Auxiliary) leakage
(ANSI/AAMI ES1, NFPA 99) and international (IEC62353, • Lead isolation (Mains on applied parts leakage)
AN/NZS 3551, and parts of IEC 60601-1) electrical-safety • Differential leakage
standards. The integrated ANSI/AAMI ES1 and
• Direct equipment leakage
IEC60601-1 patient loads are easily selectable.
• Direct applied part leakage
The Analyzer performs the following tests:
• Alternative equipment leakage
• Line (Mains) voltage • Alternative applied part patient leakage
• Ground Wire (or Protective Earth) Resistance • Point to point leakage, voltage, and resistance
• Equipment current • ECG simulation and performance waveforms

1
ESA612
Users Manual

Table 1. Symbols Safety Information


Symbol Description In this manual, a Warning identifies hazardous conditions
and actions that could cause bodily harm or death. A
W Important information; refer to manual. Caution identifies conditions and actions that could
damage the Analyzer, the equipment under test, or cause
X Hazardous voltage permanent loss of data.
Conforms to relevant Canadian and US XW Warning
) standards To avoid possible electrical shock or
personal injury, follow these guidelines:
Conforms to relevant Australian EMC
; requirements
• Use this Analyzer only in the manner
specified by the manufacturer or the
P Conforms to European Union directives protection provided may be impaired.
• Read the Users Manual before operating
Do not dispose of this product as the Analyzer.
~ unsorted municipal waste. Go to Fluke’s
website for recycling information.
• Do not connect the Analyzer to a patient or
equipment connected to a patient. The
IEC Measurement Category II – CAT II Analyzer is intended for equipment
equipment designed to protect against evaluation only and should never be used
CAT II transients from energy-consuming in diagnostics, treatment or in any other
equipment supplied from fixed capacity where the Analyzer would come
installations. in contact with a patient.

˜ Accessible Functional Earth Terminal • 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 • Use extreme caution when working with
not use the Analyzer if abnormal voltages above 30 V.
conditions of any sort are noted (such as a • Use the proper terminals, functions and
faulty display, broken case, etc.) ranges for the test being performed.
• Inspect the test leads for damaged • Do not touch metal parts of the device
insulation or exposed metal. Check test under test (DUT) during analysis. The DUT
lead continuity. Replace damaged leads should be considered an electrical shock
before using the Analyzer. hazard when connected to the Analyzer as
• When testing, always be sure to keep your some tests involve high voltages, high
fingers behind the safety barriers on the currents, and/or the removal of DUT earth
test leads. bond.
• Never open the Analyzer's case. Intended Use
Dangerous voltages are present. There are
no user replaceable parts in the Analyzer. The Analyzer is intended for use by trained service
technicians to perform periodic inspections on a wide
• Have the Analyzer serviced only by range of medical equipment. The testing procedures are
qualified personnel. menu-driven, and simple to operate.
• 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.

3
ESA612
Users Manual

Unpacking the Analyzer Instrument Familiarization


Carefully unpack all items from the box and check that Figure 1 and Table 2 describes the front-panel controls
you have the following items: and connections of the Analyzer.
• ESA612
• Getting Started Manual
• Users Manual CD 1
• Carrying case
9
• Power cord
• 15 – 20 A Adapter (USA only)
• ESA USA Accessory Kit (USA, Australia, and Israel 2
only)
• ESA EUR Accessory Kit
• Ansur demo CD 8
3
• Null Post Adapter
• 5-to-5 Banana to ECG Adapter (BJ2ECG)
4
• Transfer cable TEST

7
5

fis116.eps

Figure 1. Front-Panel Controls and Connections

4
Electrical Safety Analyzer
Instrument Familiarization
Table 2. Top-Panel Controls and Connections
Item Name Description
Item Name Description
Connection for zeroing test
Controls the configuration of 8 Nulling Jack
lead resistance.
the equipment outlet. Opens
Equipment Outlet
and closes the neutral and Keys F1 through F4 are used
1 Configuration
ground connection and to select from a number of
Buttons
reverses the polarity of the 9 Function Softkeys selections that appear in the
neutral and hot connection. LCD display above each
function softkey.
Indicates when high voltage
is applied to the
High Voltage
2 ECG/Applied Parts posts or
Indicator
L1 and L2 of the Test
Receptacle.
Test Function Selects the various Analyzer
3
Buttons test functions.
Cursor control buttons for
4 Navigation Buttons
navigating menus and lists.

5 Test Button Initiates selected tests.

Saves the measurement or


6 Save Button
ECG waveform to memory.

7 Input Jacks Test lead connectors.

5
ESA612
Users Manual

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

LL
F

LA
L

RL
N

V1
C1
TE
ST

7
2

3
8

fis110.eps

Figure 2. Side and Top-Panel Connections

6
Electrical Safety Analyzer
Instrument Familiarization
Table 3. Side and Top-Panel Connections
Item Name Description

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

USB Device Port Digital connection for controlling the Analyzer from a PC or instrument
2 controller.
(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.

A grounded male three-prong (IEC 60320 C19) connector that accepts the
6 Power Input Connector
line-power cord.

Connection posts for Device Under Test (DUT) applied parts, such as ECG
7 ECG/Applied Parts Jacks leads. Used to test for leakage current through leads and to supply ECG
signals and performance waveforms to a DUT.

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

7
ESA612
Users Manual

Connecting to Line Power Turning the Analyzer On


XWWarning Note
To avoid shock hazard and for proper To ensure the high voltage indicator is working,
Analyzer operation, connect the factory look for it to illuminate during the power-up self
supplied three-conductor line power cord to test.
a properly grounded power outlet. Do not Press the power switch on the left-side panel so the “I”
use a two-conductor adapter or extension side of the ac power switch is depressed. The Analyzer
cord; this will break the protective ground will perform a series of self tests and then display the
connection. message shown in Figure 3 when the self test has
Connect the Analyzer to a properly grounded three-prong completed successfully.
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 fis101.jpg

safety test. Figure 4 shows a DUT connected to the test Figure 3. Analyzer Ready for Operation
receptacle, applied parts posts, and a separate
connection to the DUT’s enclosure or protective earth
ground.

8
Electrical Safety Analyzer
Turning the Analyzer On

To protective earth or any exposed


conductive surface on the enclosure
RA
R

LL
F

LA
L

RL
N

V1
C1
TE
ST

fis113.eps

Figure 4. DUT Connections to the Analyzer

9
ESA612
Users Manual
During the self-test, the Analyzer checks its ac mains These icons indicate the use of E and F to select an
input for proper polarity, ground integrity and voltage applied part.
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 fis102.jpg

indicates various leakage current tests along the bottom Figure 5. Leakage Current Menu
of the display. An Exit selection is also indicated as a way The three buttons along the right side of the display
of backing out of the leakage current tests. Pressing a (PND) control the wiring of the Analyzer’s
softkey (F1 through F4) under a specific test will cause test receptacle for some electrical tests. The present state
the analyzer to setup for or perform the selected test. of these three buttons is displayed along the right edge of
In addition to the function softkeys, the Analyzer test the display whenever these controls are active.
functions may require using the navigation buttons to Figure 5 shows polarity is settable between normal,
select parameters as well. In the example above, the reversed, and off. Neutral is also settable to closed or
leakage selection has K next to it. This icon indicates the open. Earth condition is not displayed, which indicates it
selection is controlled by pressing G or H. In this can not be changed. However, earth is internally opened
example, the leakage current measurement is switched during this test.
between AC+DC, AC only, or DC only. The applied parts
indicator has W on the left end and X on the right end.

10
Electrical Safety Analyzer
Setting Up the Analyzer

Setting Up the Analyzer Setting Polarity Switching Delay


There are a number of Analyzer parameters that are When switching the polarity of the Analyzer’s test
adjusted through a setup function as well as the ability to receptacle, a delay can be set to control the actual switch
save a record by ID and date. To access the first Setup time. To set the polarity delay:
menu shown in Figure 6, press Q. 1. From the setup menu, press the softkey labeled
More to reveal additional menu selections.
2. Press the softkey labeled Instrument to reveal the
instrument setup selections.
3. Press the softkey labeled Polarity Delay to open the
scroll box above the softkey label.
4. Press G or H to adjust the delay from 0 to 5
seconds in 1 second steps.
5. Press the softkey labeled Done to exit the switching
polarity delay setup function.
Setting the Display Contrast
fis114.bmp
There are two methods for setting the display contrast.
Figure 6. Setup Menu
From the Select a Test…. menu or through the setup
Note menu.
See the Using Memory section later in this Whenever the Analyzer displays its start-up menu (Select
manual for a description of how to enter a test a test…), pressing G or H will increase or decrease the
record ID. display’s contrast respectively. Press the softkey labeled
The setup parameters have been grouped into six Done to exit contrast setup.
categories: Instrument, Display, Sound, Instrument Info, Another way to adjust the contrast is through the
Calibration, and Diagnostics. Analyzer’s setup menu.

11
ESA612
Users Manual
1. From the setup menu, press the softkey labeled Viewing Memory
More twice to set F1 to the display contrast function.
Refer to the Using Memory section later in the manual to
2. Press the softkey labeled Display Contrast. learn about viewing memory and how to store data in the
3. Press G or H to increase or decrease the display’s Analyzer.
contrast respectively. Setting the GFCI Limit
4. Press the softkey labeled Done to exit contrast To set the GFCI current limit:
setup.
1. From the setup menu, press the softkey labeled
Setting up the Beeper More to reveal additional menu selections.
To enable or disable the beeper: 2. Press the softkey labeled Instrument to reveal the
1. From the setup menu, press the softkey labeled instrument setup selections.
More twice to set F2 to the beeper on/off function. 3. Press the softkey labeled GFCI Limit to open the
2. Press the softkey labeled Beeper to switch the scroll box above the softkey label.
beeper on and off. 4. Press G or H to adjust the current limit from 5 to
3. Press the softkey labeled Done to go back to the 25 mA.
setup menu. 5. Press the softkey labeled Done to exit the GFCI Limit
Viewing Instrument Information setup function.

To view information about the Analyzer: Performing Electrical Safety Tests


1. From the setup menu, press the softkey labeled The Analyzer is designed to perform a number of different
More twice to set F3 to the instrument information electrical and performance tests on biomedical
function. equipment. The following sections describe the various
tests and how to perform them using the Analyzer.
2. Press the softkey labeled Instrument Information.
3. After viewing the displayed information, press the
softkey labeled Done to exit the information screen.

12
Electrical Safety Analyzer
Performing Electrical Safety Tests
Setting the Test Standard
The Analyzer is designed to perform electrical safety
testing based on a number of different safety standards:
AAMI ES1/NFPA99, IEC62353, IEC60601-1, and
AN/NZS 3551. AAMI is the Analyzer’s default standard.
To select another standard:
1. Press Q.
2. From the setup menu, press the softkey labeled
More to reveal additional menu selections.
3. Press the softkey labeled Instrument to reveal the
instrument setup selections. fis104.jpg

Figure 7. Mains Voltage Test Menu


4. Press the softkey labeled Standard to open the
scroll box above the softkey label. Press each function softkey to perform each of the three
5. Press G or H to scroll through the standard measurements: Live to neutral, neutral to earth, and live
selections. to earth.

6. When the desired standard is displayed, press the Note


softkey labeled Done. Power to the test receptacle is off during the
Mains Voltage test.
Some electrical tests may not be applicable for a specific
standard. In these cases, the Analyzer’s menu will not Performing a Ground Wire (Protective Earth)
display the excluded test as a selection. Resistance Test
Performing Mains Voltage Testing The Ground Wire (Protective-Earth) Resistance test
measures the impedance between the Analyzer’s test
The Mains Voltage test measures the voltage on the
receptacle’s PE terminal and the exposed conductive
mains input through three separate measurements. To
parts of the DUT that are connected to the DUT’s
access the Mains Voltage test, press V. The Mains
Protective Earth.
Voltage test menu is shown in Figure 7.

13
ESA612
Users Manual
Prior to conducting any leakage tests with the Analyzer, it the DUT enclosure or protective earth connection.
is best to test the integrity of the ground connection 8. The measured resistance is displayed as shown in
between the Analyzer’s test receptacle ground and the Figure 8 after the DUT connection(s) is/are made.
DUT’s Protective earth ground or enclosure with this test.
To access the Ground Wire (Protective Earth) ∅/Null
Resistance Test menu press O.
Note
The DUT is powered off for this test.
To perform a ground wire resistance test:
1. Ensure the power cord from the DUT is plugged into
the Analyzer’s test receptacle.
2. Press O to reveal the resistance function menu.
3. Connect one end of a test lead to the V/Ω/A jack as
shown in Figure 9. fis105.jpg

Figure 8. DUT Ground Resistance Measurement


4. If using an accessories probe, connect it to the other
end of the test lead and place the probe tip into the WX Warning
∅/Null jack. If using an alligator clip accessory, To avoid electric shock, remove the null post
connect it to the other end of the test lead, place the adapter from the ∅/Null jack after a test lead
null post adapter in the ∅/Null jack, and clamp the zero is performed. The ∅/Null jack becomes
alligator clip to the null post adapter. potentially hazardous during some of the test
5. Connect the other end of the test lead to ∅/Null jack. conditions.
6. Press the softkey labeled Zero Leads. The Analyzer A low resistance reading is required to confirm a good
zeroes out the measurement to cancel the test lead ground connection through the power cord. Refer to the
resistance. appropriate electrical safety standard for the specific limit
value to be followed.
7. Connect the test lead coming from the ∅/Null jack to

14
Electrical Safety Analyzer
Performing Electrical Safety Tests
Figure 9 shows the electrical connections between the
Analyzer and the DUT. Table 4 lists the abbreviations
used in the schematics and their descriptions.

15
ESA612
Users Manual

To protective earth or any exposed


conductive surface on the enclosure
RA
R

LL
F

LA
L

RL
N

V1
C1
TE
ST

fis112.eps

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

16
Electrical Safety Analyzer
Performing Electrical Safety Tests
Table 4. Schematic Abbreviations
Abbreviation Meaning

MD Measuring Device (ESA612 Analyzer)


FE Functional Earth
PE Protective Earth
Mains Mains Voltage Supply
L1 Live Conductor
L2 Neutral Conductor
DUT Device Under Test
DUT_L1 Device Under Test Live conductor
DUT_L2 Device Under Test neutral conductor
DUT_PE Device Under Test protective earth
REV POL Reversed mains supply polarity
LEAD GND Lead to ground, used in Patient leakage test
MAP Mains on Applied Part
MAP REV Reverse mains on applied part source voltage
PE Open Open protective earth
Test Voltage

17
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

EARTH
OPEN
DUT_PE FE

PE

CONDUCTIVE PART
MD
TEST LEAD

faw26.eps

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

18
Electrical Safety Analyzer
Performing Electrical Safety Tests
Performing an Insulation Resistance Test
The five insulation resistance tests take measurements on
mains (L1 & L2) to Protective earth, applied parts to
Protective earth, mains to applied parts, mains to non-
earthed accessible conductive points, and applied parts to
non-earthed accessible conductive points.
To access the Insulation Resistance Test menu,
press M.
All Insulation Resistance Tests can be performed using
500 or 250 volts dc. To change the test voltage from the
Insulation Resistance Test menu, press the softkey fis106.jpg
labeled More. Pressing the softkey labeled Change Figure 11. Insulation Resistance Measurement
Voltage will cause the test voltage to toggle between 250
and 500 volts dc. After selecting one of the tests by pressing the appropriate
softkey, press T to apply the selected voltage to the
Note DUT and take the resistance measurement.
Exiting and re-entering the Insulation Resistance Figures 12 through 16 shows the electrical connections
Test menu causes the test voltage to return to its between the Analyzer and DUT for the five insulation
default value of 500 volts dc.
resistance tests.
As shown in Figure 11, three of the five tests are shown
over function soft keys F1 through F3. To access the other Note
two tests or test voltage selection, press the softkey The DUT is powered off for this test.
labeled More. The softkey labeled Back will move the
menu back up to the top-level insulation resistance test
menu.

19
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2
MD

DUT_PE
FE

CONDUCTIVE PART

faw17.eps

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

20
Electrical Safety Analyzer
Performing Electrical Safety Tests

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

DUT_PE
FE

MD CONDUCTIVE PART

faw18.eps

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

21
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

MD

DUT_PE
FE

CONDUCTIVE PART

faw19.eps

Figure 14. Mains to Applied Parts Insulation Test Schematic

22
Electrical Safety Analyzer
Performing Electrical Safety Tests

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

MD

DUT_PE
FE

CONDUCTIVE PART

TEST
LEAD

faw20.eps

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

23
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

DUT_PE
FE

CONDUCTIVE PART

TEST
LEAD
MD

faw21.eps

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

24
Electrical Safety Analyzer
Performing Electrical Safety Tests

Performing a Current Consumption Test Which leakage tests are available depends on which
standard is selected. See the Selecting the Test Standard
To measure the current consumed by the DUT, press
section earlier in this manual to change the standard the
A. The Analyzer displays the current flowing through
Analyzer is using.
the mains connections of the test receptacle.
Table 5 lists six leakage current tests that have different
Performing Leakage Current Tests names based on which standard is selected.
The Analyzer measures leakage current for a number of Press B to access the leakage current main menu
different DUT configurations. In addition to the leakage shown in Figure 17.
found on the enclosure and the earth connection, the
Analyzer can measure leakage on each connected applied
part and combinations of connected applied parts.
Table 5. Test Names Based on Selected Standard
IEC60601 AAMI/NFPA 99

Protective Earth Resistance Ground Wire Resistance

Earth Leakage Current Ground Wire Leakage Current

Touch or Enclosure Leakage Current Chassis Leakage Current

Patient Leakage Current Lead to Ground Leakage Current

Patient Auxiliary Leakage Current Lead to Lead Leakage Current

Mains on Applied Part (MAP) Leakage Current Isolation Leakage Current

25
ESA612
Users Manual
Measuring Earth Leakage Current
Note
The Ground Wire (Earth) Leakage test is
available for AAMI, 60601, and not IEC 62353.
To measure the current flowing in the DUT’s protective
earth circuit, press the softkey labeled Ground Wire
(pending the standard) from the leakage current main
menu. Figure 18 shows the electrical connections between
the Analyzer and the DUT during a Ground Wire Leakage
Current Test.
fis117.jpg Within the Ground Wire Leakage Current test there are a
Figure 17. Leakage Current Main Menu few combination measurements that can be performed.
Pressing P switches the polarity of the mains voltage
Note applied to the Analyzer’s test receptacle between Normal,
The display shown in Figure 17 is the main Off, Reverse, and Off. Pressing N opens and closes
leakage current menu when AAMI is the selected the neutral connection to the Analyzer’s test receptacle.
standard. There is no need to open up the test receptacle earth
All leakage currents, with the exception of Lead Isolation (ground), since this is done internally during the
(Mains on Applied parts), are displayed in one of three measurement.
ways: AC+DC, AC Only, or DC only. The initial result is The following outlet conditions apply when performing this
displayed in the appropriate parameter based on the test:
standard selected. To change the displayed parameter,
• Normal Polarity
press G or H. The present measurement method is
displayed to the right of the current measurement while • Normal Polarity, Open Neutral
leakage current tests are conducted. • Reversed Polarity
• Reversed Polarity, Open Neutral

26
Electrical Safety Analyzer
Performing Electrical Safety Tests
IEC60601-1 specifies that the applied parts should be
connected for this measurement. Enable this
measurement by pressing E or F which grounds and
ungrounds all applied parts connection posts.

27
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
REV
POL
EARTH
OPEN
DUT_PE
FE

CONDUCTIVE PART
MD

PE
APPLIED PART
OPEN

faw27.eps

Figure 18. Earth Leakage Current Test Schematic


Note
Ground wire leakage is the same schematic without the Applied Parts switch.

28
Electrical Safety Analyzer
Performing Electrical Safety Tests
Performing a Chassis (Enclosure) Leakage Test • Normal Polarity, Open Neutral
Note • Reversed Polarity
The Chassis (Enclosure) Leakage test is only • Reversed Polarity, Open Earth
available for the IEC60601 or ANSI/AAMI ES1 • Reversed Polarity, Open Neutral
1993 standard selections. IEC60601-1 specifies that the applied parts should be
The Chassis (Enclosure) Leakage Test measures the connected for this measurement. Enable this
current flowing between the DUT’s enclosure and measurement by pressing E or F which grounds and
protective earth. Figure 19 shows the electrical ungrounds all applied parts connection posts.
connections between the Analyzer and the DUT.
To perform a Chassis (Enclosure) Leakage Test:
1. Connect a lead between the Analyzer’s V/Ω/A jack
and the DUT’s enclosure.
2. Press the softkey labeled Chassis from the Leakage
Current Test menu.
3. The Analyzer displays the measured current.
The Chassis Leakage test can be performed with a
number of fault conditions on the test receptacle. Press
P to switch the test receptacle between Normal, Off,
Reverse, and Off. Press N to open and close the
neutral connection to the receptacle. Press D to open
and close the receptacle’s earth connection.
The following outlet conditions apply when performing this
test:
• Normal Polarity
• Normal Polarity, Open Earth

29
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1

L1
APPLIED
PART
MAINS
L2
OPEN DUT_L2

L2

EARTH
OPEN
DUT_PE
FE

CONDUCTIVE PART

MD TEST LEAD

PE APPLIED PART
OPEN

faw28.eps

Figure 19. Enclosure Leakage Current Test Schematic


Note
Chassis leakage is the same schematic without the Applied Parts switch.

30
Electrical Safety Analyzer
Performing Electrical Safety Tests

Performing a Lead-to-Ground (Patient) Leakage The Lead-to-Ground Leakage test can be performed with
a number of fault conditions on the test receptacle. Press
Test
P to switch the test receptacle between Normal, Off,
Note Reverse, and Off. Press N to open and close the
The Lead-to-Ground (Patient) Leakage Current neutral connection to the receptacle. Press D to open
Test is not available for IEC 62353 standard and close the receptacle’s earth connection.
selections. The following outlet conditions apply when performing this
The Lead-to-Ground (Patient) Leakage Current test test:
measures the current flowing between a selected applied • Normal Polarity
part, selected group of applied parts, or ALL applied parts,
• Normal Polarity, Open Neutral
and the Mains PE. Figure 20 shows the electrical
connections between the Analyzer and the DUT. • Normal Polarity, Open Earth
• Reversed Polarity
To perform a Lead-to Ground (Patient) leakage test:
• Reversed Polarity, Open Neutral
1. Press B.
• Reversed Polarity, Open Earth
2. Press the soft key labeled More.
Note
3. Select one of the applied part groupings by pressing
If there are more than five applied parts to
G or H.
connect to the Analyzer, see Using the 1210
Note Adapter later in this manual.
Refer to the testing standard when deciding the
type of the applied parts and how they should be
grouped for testing.
4. Press the soft key labeled Select.
5. Press F or E to advance through each applied part
grouping, or the individual applied parts, to ground.
These are selected and measured.

31
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1
L1
APPLIED
PART
MAINS L2
DUT_L2
OPEN
L2
REV
POL
EARTH
OPEN DUT_PE
FE

CONDUCTIVE PART

LEAD SELECT
MD
PE

LEAD GND

faw29.eps

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

32
Electrical Safety Analyzer
Performing Electrical Safety Tests

Performing Lead-to-Lead (Patient Auxiliary) Leakage different combinations of posts tied together: RA/R and
Tests LL/F, RA/R and LA/L, or LL/F and LA/L.

Note
The Lead-to-Lead (Patient Auxiliary) leakage test
is available when the IEC60601 or ANSI/AAMI
ES1-1993 standard is selected.
To measure the leakage current through each applied part
or lead and selected combination of lead connections (all
fis107.eps
other or between two), press the softkey labeled Lead to
Lead from the Leakage Test main menu shown in Figure 21. Applied Parts Connection Posts Display
Figure 17. Figure 22 shows the electrical connections Within the Lead-to-Lead (Patient Auxiliary) Leakage test, a
between the Analyzer and the DUT during a Lead-to-Lead number of fault measurements can be made. Pressing
(Patient Auxiliary) Leakage Current Test. P switches the polarity of the mains voltage applied
The Lead-to-Lead (Patient Auxiliary) Leakage test adds a to the Analyzer’s test receptacle between Normal, Off,
diagram of the applied parts connection posts to the Reverse, and Off. Pressing N opens and closes the
display, as shown in Figure 21. In the figure, the applied neutral connection to the Analyzer’s test receptacle.
parts post RA/R is shown above the other posts. This Pressing Dopens and closes the earth or ground
indicates that the leakage measurement is being made connection to the Analyzer’s test receptacle.
from RA/R to all others. To move to the next applied part
post, press F. The first post will appear inline with the
other posts while the LL/F post appears above all others. Note
This indicates the second leakage measurement is being If there are more than five applied parts to
made from LL/F to all others. Continue pressing F or E to connect to the Analyzer, see Using the 1210
move from one connection post to another and noting the Adapter later in this manual.
measured current in the display.
After each post is isolated individually, the Lead-to-Lead
(Patient Auxiliary) Leakage test measures current of three

33
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1
L1 APPLIED
PART
MAINS L2
DUT_L2
OPEN
L2
REV
EARTH POL
OPEN DUT_PE
FE
CONDUCTIVE PART
PE
+ LEAD

MD
- LEAD

GROUND LEAD

faw30.eps

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

34
Electrical Safety Analyzer
Performing Electrical Safety Tests
The following outlet conditions apply when performing this 1. Press B.
test: 2. Press the soft key labeled More.
• Normal Polarity 3. Select the desired applied part groupings using
• Normal Polarity, Open Neutral G and H.
• Normal Polarity, Open Earth
Note
• Reversed Polarity, Open Neutral
Refer to the testing standard when deciding the
• Reversed Polarity, Open Earth type of the applied parts and how they should be
Performing a Lead Isolation (Mains on Applied grouped for testing.
Part) Leakage Test 4. Press the soft key labeled Select.
Note 5. Press the soft key labeled Lead Isolation.
The Lead Isolation (Mains on Applied Part) 6. Press F or E to select the desired applied part
leakage test is available when the IEC60601 & connection.
ANSI/AAMI standard is selected. 7. Press T to apply the voltage and read the leakage
The Lead Isolation (Mains On Applied Parts) Leakage current in the display.
Current test measures the current that flows in response Pressing E and F scrolls through the applied part
to an isolated AC voltage applied between a selected connections or groupings. Press T for each
applied part, group of applied parts, or ALL applied parts, connection configuration to thoroughly test the DUT.
and Earth (and any conductive part connected to the RED
terminal). Figure 23 shows the electrical connections The following outlet conditions apply when performing this
between the Analyzer and the DUT during a Mains on test:
Applied Part Leakage Current Test. • Normal Polarity
Note • Reverse Polarity
With 60601 standard selected, the MAP test Note
voltage is available in both Normal and Reverse If there are more than five applied parts to
(180 degrees out of phase with mains). connect to the Analyzer, see Using the 1210
To perform a Lead Isolation (Mains on Applied Part) test: Adapter later in this manual.

35
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1

L1
APPLIED
PART
MAINS
L2
OPEN DUT_L2

L2
REV
POL
EARTH OPEN
DUT_PE
FE
CONDUCTIVE PART

TEST LEAD

PE

MD

LEAD SELECT
MAP (ISOLATION)
TRANSFORMER

MAP
REV

faw31.eps

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

36
Electrical Safety Analyzer
Performing Electrical Safety Tests

Performing an Alternative Equipment Leakage The following outlet conditions apply when performing this
Test test:
• Closed Earth
Note
• Open Earth
The alternative equipment leakage test is
available when the EN62353 standard is Note
selected. If there are more than five applied parts to
During the Alternative Equipment Leakage test, the connect to the Analyzer, see Using the 1210
voltage source is applied between short-circuited Adapter later in this manual.
equipment outlet mains live, neutral, and equipment outlet Performing an Alternative Applied Part Leakage
earth, the exposed conductive surface on the housing, and Test
all applied parts short-circuited together. Equipment is
separated from mains during the test. The current which Note
flows over the insulation of the DUT is measured. The Alternative applied part leakage test is
This test is not applicable for equipment with internal available when the EN62353 standard is
electrical power source. The switches in mains part shall selected.
be closed during measurement. During the Alternative Applied Part Leakage test, the test
voltage is applied between short-circuited applied parts of
To perform an alternative equipment leakage test:
a single function and the short-circuited equipment outlet
1. Press B. mains live, neutral, equipment outlet earth, and exposed
2. Press the softkey labeled Alternative Equipment. conductive surface on the housing. This test should only
be done for equipment with F-Type applied parts. For
3. Press T to apply the voltage and read the current
equipment with multiple applied parts, test each group of
in the display.
applied parts of a single function in turn with all others
Figure 24 shows the electrical connections between the floating during the test. All applied parts can be connected
Analyzer and the DUT during an Alternative Equipment to the Analyzer’s applied parts jacks and the lead selection
Leakage Test. will float those not selected.

37
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1

APPLIED
PART

DUT_L2

DUT_PE
FE

CONDUCTIVE PART

PE TEST
OPEN LEAD

MD

faw22.eps

Figure 24. Alternative Equipment Leakage Current Test Schematic

38
Electrical Safety Analyzer
Performing Electrical Safety Tests
To perform an alternative applied part leakage test: The Direct Equipment Leakage Current test measures the
1. Press B. leakage current between all applied parts and the exposed
conductive surface on the housing, to mains earth.
2. Press the soft key labeled More.
To perform a direct equipment test:
3. Select the desired applied part groupings using
G and H. 1. Press B.

4. Press the soft key labeled Select. The direct equipment test is the default test and should
already be selected.
5. Press the soft key labeled Alternative A.P..
2. Press T to apply the voltage and read the leakage
6. Press T to apply the test voltage and read the current in the display
current in the display.
Figure 26 shows the electrical connections between the
7. Press F or E to advance to the next applied part Analyzer and the DUT during a Direct Equipment Leakage
group(s) of a single function if applicable. Pressing Current Test.
T to read leakage current for each group.
The following outlet conditions apply when performing this
Figure 25 shows the electrical connections between the test:
Analyzer and the DUT during an Alternative Applied Part
Leakage current test. • Normal Polarity, Closed Earth
• Normal Polarity, Open Earth
Note
• Reversed Polarity, Closed Earth
If there are more than five applied parts to
• Reversed Polarity, Open Earth
connect to the Analyzer, see Using the 1210
Adapter later in this manual.
Note
Performing a Direct Equipment Leakage Test If there are more than five applied parts to
connect to the Analyzer, see Using the 1210
Note Adapter later in this manual.
The Direct Equipment Leakage test is available
when the EN62353 standard is selected.

39
ESA612
Users Manual

DEVICE UNDER TEST


DUT_L1
AP1

APPLIED
PART
AP2

DUT_L2

DUT_PE
FE

CONDUCTIVE PART

TEST
LEAD

MD

faw23.eps

Figure 25. Alternative Applied Part Leakage Test Schematic

40
Electrical Safety Analyzer
Performing Electrical Safety Tests
Performing a Direct Applied Part Leakage Test 7. Press F or E to advance to the next group of applied
parts, if applicable.
Note
The Direct Applied Part Leakage test is available Figure 27 shows the electrical connections between the
when the EN62353 standard is selected. Analyzer and the DUT during a Direct Applied Part
Leakage Current Test.
The Direct Applied Part Leakage Current test measures
the leakage current between all applied parts of a single The following outlet conditions apply when performing this
function and the exposed conductive surface on the test:
housing, to mains earth. For equipment with multiple • Normal Polarity
applied parts, each group of a single function should be • Reversed Polarity
tested each in turn with all other floating during the test.
This test should only be done for equipment with F-Type
applied parts. Note
For Type B applied part, see direct equipment leakage If there are more than five applied parts to
schematic in Figure 26. connect to the Analyzer, see Using the 1210
Adapter later in this manual.
To perform a direct applied part leakage test:
1. Press B.
2. Press the soft key labeled More.
3. Select the desired applied part groupings using
G and H.
4. Press the soft key labeled Select. The Direct A.P. test
should already be selected.
5. Press F or E to select the applied part test
configuration.
6. Press T to apply the test voltage and read the
current in the display.

41
ESA612
Users Manual

MAINS DEVICE UNDER TEST


ON DUT_L1

L1
APPLIED
PART
MAINS L2
OPEN DUT_L2

L2
REV
POL
PE
OPEN
DUT_PE
FE

CONDUCTIVE PART
MD
TEST
LEAD

faw24.eps

Figure 26. Direct Equipment Leakage Test Schematic

42
Electrical Safety Analyzer
Performing Electrical Safety Tests

MAINS DEVICE UNDER TEST


ON DUT_L1
AP1
L1
APPLIED
PART
AP2
MAINS L2
OPEN DUT_L2

L2
REV
POL

DUT_PE
FE

CONDUCTIVE PART

MD

faw25.eps

Figure 27. Direct Applied Parts Leakage Current Test Schematic

43
ESA612
Users Manual
Performing a Differential Leakage Current Test Note
Note If there are more than five applied parts to
connect to the Analyzer, see Using the 1210
The Differential Leakage Current test is available Adapter later in this manual.
when the EN62353 standard is selected.
The differential leakage current test measures the
magnitudes of the differential current flowing in the
Equipment Outlet live and neutral, with power applied to
the equipment outlet. All applied parts should be
connected during this test, if equipment has applicable
applied parts.
To perform a differential leakage current test:
1. Press B.
2. Press the soft key labeled Differential.
Figure 28 shows the electrical connections between the
Analyzer and the DUT during a Differential Leakage
Current test.
The following outlet conditions apply when performing this
test:
• Normal Polarity, Closed Earth
• Normal Polarity, Open Earth
• Reversed Polarity, Closed Earth
• Reversed Polarity, Open Earth

44
Electrical Safety Analyzer
Performing Electrical Safety Tests

MAINS DEVICE UNDER TEST


ON DUT_L1

L1
APPLIED
MD PART
MAINS L2
OPEN DUT_L2

L2
REV
POL

FE

EARTH
OPEN
DUT_PE

PE
CONDUCTIVE PART

TEST
LEAD

faw32.eps

Figure 28. Differential Leakage Current Test Schematic

45
ESA612
Users Manual

Using the 1210 Adapter


The 1210 Adapter, an optional accessory, is designed to
increase the number of lead or applied parts connections
to the Analyzer from five to 14. The adapter itself ties up to
ten leads together into a single lead that is plugged into
one of the input jacks of the Analyzer. The four remaining
Analyzer input jacks can also be used in conjunction with
the Adapter.
Figure 29 shows one application of the Adapter. The
Defibrillator/Monitor in the example has ten ECG leads,
two pacer leads, and two defibrillator paddles which need
to be tested together, and in groups if single function, for
current leakage per IEC62353. The example shows the
ECG leads to be snap type connectors and two BJ2ECG
adapters are shown plugged into the Adapter. If the ECG
leads did not have snap connectors, then the Universal
Snap to Banana Adapter can be used to make the
connections to the Adapter. The common lead from the
st
Adapter is plugged into the RA jack (1 jack) of the
Analyzer. Using four sheathed test leads with alligator
clips, connect the two defibrillator paddles into the LL and
LA Analyzer jacks and the two pacer leads into the RL and
V1 jacks. Using the selection that ties all five Analyzer
jacks together will test all fourteen leads for leakage
current. Using the selection of applied part group of 1, 2,
and 2 allows for testing of groups of applied parts of single
function.

46
Electrical Safety Analyzer
Using the 1210 Adapter

Defibrillator/Pacer ESA612

DEFIB
OFF
PACER

1210

fis120.eps

Figure 29. 1210 Adapter Connections

47
ESA612
Users Manual
When performing an applied parts test using the
AAMI/NFPA-99 standard, the normal connections of RA,
LL, LA, and RL are made to their associated Analyzer
input jacks. Four adapters from the Universal Snap to
Banana Adapter set will be required for the first four
connections. The remaining chest leads are connected to
the Adapter and the common lead from the Adapter is
th
plugged into the V1 jack (5 jack) of the Analyzer. See
Figure. 30. This configuration allows for isolation of the
RA, LL, LA, and RL leads from each other and the
remaining chest leads, which are shorted together, while
performing leakage tests.

48
Electrical Safety Analyzer
Using the 1210 Adapter

ECG Monitor
ESA612

1210

fis121.eps

Figure 30. EGC Lead Connection with 1210 Adapter

49
ESA612
Users Manual

Making Point-To-Point Measurements 3. Place the probe tips across the unknown voltage and
read the measurement in the Analyzer’s display.
The Analyzer can make voltage, resistance, and low
current measurements through its Point-to-Point function. The Analyzer will measure up to 300 volts ac.
To access the Point-to-Point function menu shown in Measuring Resistance
Figure 31, press R. Softkeys F1 through F3 are used
To make a resistance measurement:
to select the measurement function.
1. Press the softkey labeled Resistance from the
Point-To-Point menu.
2. Insert test leads in the RED (V/Ω/A ) and BLACK
jacks.
3. Null lead resistance by shorting the leads together
and pressing the softkey labeled Zero Leads.
4. Place the probes across the unknown resistance and
read the measurement in the Analyzer’s display.
The Analyzer will measure resistances up to 2.0 Ω.

fis108.jpg

Figure 31. Point-To-Point Function Menu


Measuring Voltage
To make a voltage measurement:
1. Press the softkey labeled Voltage from the
Point-To-Point menu.
2. Insert test leads in the RED (V/Ω/A ) and BLACK
jacks.

50
Electrical Safety Analyzer
Simulating ECG Waveforms
Measuring Current Note
The Analyzer can make dc only, ac only, and ac+dc If the ECG monitor/interpreter has banana posts
current measurements up to 10 mA. To make a current instead of snaps, use the optional universal snap
measurement: to banana adapter to connect to the Analyzer.

1. Press the softkey labeled Leakage from the To access the ECG Simulation Waveform menu shown in
Point-To-Point menu. Figure 32, press C. From this menu, a number of
different waveforms are selected through F1, and the rate
2. Using G or H select between ac only, dc only, or or frequency of the waveform is selected through F2.
ac+dc measurement mode.
3. Insert test leads in the RED (V/Ω/A ) and BLACK
jacks.
4. Place the leads on the two points the unknown
current may flow and read the measurement in the
Analyzer’s display.
Simulating ECG Waveforms
The Analyzer is capable of generating various waveforms
on the applied parts connection posts. These signals are
used to test the performance characteristics of ECG
monitors and ECG strip printers. See Figure 33 for proper
fis109.jpg
connections between the Analyzer and an ECG monitor.
Figure 32. ECG Waveform Simulation Menu
For monitors using the snap style connectors, insert the
BJ2ECG adapter into the connectors at the top of the To select one of the predefined waveforms, press the
Analyzer and connect the monitor leads to the snap softkey labeled Wave Form. A scroll box with K next to it
connectors on the adapter. appears above the softkey label. Use G or H to scroll
through the different waveforms.
For all waveforms except VFIB and Triangle, the rate or
frequency of the waveform is adjusted through the softkey

51
ESA612
Users Manual
labeled Frequency or Rate. For some waveforms, there
are more than two frequency or rate selections. For those
waveforms, pressing the softkey labeled Frequency or
Rate will open a scroll box above the softkey label with K
next to it. Use G or H to select the frequency or rate. For
those waveforms that have only two frequency or rate
selections, the softkey labeled Frequency or Rate acts as
a toggle, where each press of the softkey switches to the
other value.

52
Electrical Safety Analyzer
Simulating ECG Waveforms

ECG Monitor

RA
R

LL
F

LA
L

RL
N

R
RA
F
V1
C1

LL
L
LA
N
RL
C1
V1
TE
ST

BJ2ECG
Adapter

fis115.eps

Figure 33. ECG Monitor Connections

53
ESA612
Users Manual

Using Memory 5. Press (enter save button) to store the Test Record ID.
The non-volatile memory of the Analyzer will store up to 6. Use G, H, F, and E to enter the date of the Test
500 measurements or ECG information for each of 100 Record.
different Test Records. Each test record can be recalled to 7. Press Y to store the date.
the display of the Analyzer or exported to a PC. Data
The Test Record ID is displayed in the upper-left
Viewer software, available at
corner of the display.
www.flukebiomedical.com/ESA612, is required to upload
memory data to a PC. Installation and operator Note
instructions are also located on the software web page. If no record ID data is entered, a default ID of
Note 0000000000000001 and a date of --/--/-- is
assigned to the record.
It is recommended that memory data be
uploaded daily or as often as possible to reduce
upload time.
Storing Data into Memory
Each of the six measurement functions allow data storage
within the Analyzer. The ECG function allows storage of
the simulated waveforms only for reference of tests
performed. To store data, a Test Record ID should be
created first. To input a new Test Record ID:
1. Press Q to open the screen shown in Figure 34.
2. Press G or H to set the first character. Available
characters are 0-9, A-Z, and space. fis114.bmp

Figure 34. Test Record ID Entry Screen


3. Press F to move to the next character position.
8. After selecting a function, push Y to store the
4. Fill in up to 15 character positions to identify a test
measurement or ECG signal under the Test Record
record.
ID.

54
Electrical Safety Analyzer
Controlling the Analyzer Remotely
After performing and saving all the tests for one Test 1. Press Q.
Record ID, enter a new Test Record ID to close the 2. Press the softkey labeled More to reveal additional
previous record and start a new one. menu selections.
Note 3. Press the softkey labeled View Memory.
A previously closed record can not have 4. Select the desired Test Record by pressing G or H
measurements or ECG signals added to it. Data
to scroll through the records listed in the display.
can only be stored under the most recently
opened record. 5. Press the softkey labeled Delete.
Viewing Memory Data Note
Previously stored data for any Test Record is recalled to All Test Records can be deleted at this point by
the screen through the setup menus. To recall data: pressing the softkey labeled Delete All.
1. Press Q. 6. When Delete? appears in the display, press the
softkey labeled Delete to remove the record from
2. Press the softkey labeled More to reveal additional
memory. Otherwise press the softkey labeled Cancel
menu selections.
to return to the Test Record list and leave the
3. Press the softkey labeled View Memory. selected record in memory.
4. Select the desired Test Record by pressing G or H Note
to scroll through the records listed in the display.
Deleting the last or current record does not open
5. Press the softkey labeled View to view the data the previous record for additional data storage.
stored for the selected record. Only a new Test Record can be opened for data
recording after deleting the last record.
If the stored data is more than can fit on one screen, press
the softkey labeled Next Page to view the additional data. Controlling the Analyzer Remotely
Deleting Data from Memory Fluke Biomedical Ansur test automation software allows a
To delete a Test Record and its associated data from solutions-based approach to complete testing of the
memory: medical device under test (DUT). Ansur helps create
standard work using the test template/sequence (which is

55
ESA612
Users Manual
based on a user written test procedure), and integrates all with the options and capabilities needed for the instrument
test results into a single test report which can be printed or being tested.
archived. Ansur allows for automatic comparisons to the
limits of the standard selected, indicating whether results
Maintenance
are passing or failing. Ansur manages test procedures by The Analyzer needs little maintenance or special care.
allowing both manual and visual automated test However, treat it as a calibrated measuring instrument.
sequences. Avoid dropping or other mechanical abuse that could
The software works hand-in-hand with Fluke Biomedical cause a shift in the calibrated settings.
analyzers and simulators, creating a seamless integration Testing and Replacing the Fuses
for:
XW Warning
• Visual inspections
To prevent electric shock, remove all power
• Preventive maintenance cords and test leads from the Analyzer before
• Work procedures opening the fuse door.
• Performance tests For electrical protection of the equipment outlet, the
• Safety tests Analyzer uses two fuses, one in the live (L1) line and one
Ansur software utilizes plug-in modules to work with a in the neutral (L2) line. To test the fuses, do the following
wide array of Fluke Biomedical instruments. The plug-in while referring to Figure 35:
module is a software interface to the Ansur test program. 1. Turn the Analyzer so the case bottom is facing up.
The plug-in modules are available for purchase as an
2. Flip up the tilt stand.
optional accessory. Plug-ins provide test elements used
by Ansur. This has the benefit of using the same user 3. Remove the fuse door from the Analyzer by removing
interface for all analyzers and simulators supported by an the screw holding the fuse door with a #2 Phillips
Ansur plug-in. head screwdriver and lifting the fuse door from the
Analyzer.
When a new Fluke Biomedical analyzer or simulator is
purchased, simply update your existing Ansur software by 4. Remove the fuses from the Analyzer.
installing a new plug-in. Each plug-in module works only

56
Electrical Safety Analyzer
Cleaning the Analyzer

Cleaning the Analyzer


XW Warning
To avoid electric shock, do not clean the
Analyzer plugged into mains or attached to a
DUT.
F1 - F2
W Caution
Do not pour fluid onto the Analyzer surface;
fluid seepage into the electrical circuitry may
cause the Analyzer to fail.
W Caution
Do not use spray cleaners on the Analyzer;
such action may force cleaning fluid into the
Analyzer and damage electronic components.
fis111.eps Clean the Analyzer occasionally utilizing a damp cloth and
Figure 35. Fuse Access mild detergent. Take care to prevent the entrance of
5. Using a multimeter, measure the continuity of each liquids.
fuse. Wipe down the adapter cables with the same care. Inspect
If one or both fuses do not show continuity, replace them for damage to and deterioration of the insulation.
the fuse(s) with fuses that have the same current and Check the connections for integrity before each use.
voltage rating. Appropriate fuse ratings are posted on
the case bottom label of the Analyzer. Table 6 lists
available fuses with Fluke Biomedical part numbers.
6. Reinstall the fuse door and secure it with the screw.

57
ESA612
Users Manual

Replaceable Parts
Table 6 lists the replaceable parts for the Analyzer.

Table 6. Replaceable Parts


Item Fluke Biomedical Part Number

ESA612 Getting Started Manual 3334511

ESA612 Users Manual CD 3334509

USA 2238680

UK 2238596

Australia 2238603

Europe 2238615
Power Cord
France/Belgium 2238615

Thailand 2238644

Israel 2434122

Switzerland 3379149

Null Post Adapter 3326842

Ansur, CD with demo version 2795488

5-to-5 Banana jack to ECG (BJ2ECG) adapter 3359538

58
Electrical Safety Analyzer
Replaceable Parts
Table 6. Replaceable Parts (cont.)
Item Fluke Biomedical Part Number

Carrying Case 2248650

Data Transfer Cable 1626219


USA WT20A 250V Fuse (Time Lag), 1¼″ x ¼″ 2183691
Australia, Switzerland WT10A 250V Fuse (Time Lag), 1¼″ x ¼″ 109298
Fuse
Europe, UK, Thailand,
WT16A 250V Fuse (Time Lag), 6.3 mm x 32 mm 3321245
France/Belgium, Israel
15 – 20 A Adapter 2195732
ESA USA/AUS/ISR Accessory Kit:
Test Lead Set
3111008
TP1 Test Probe Set
AC285 Alligator Clip Set
ESA EUR Accessory Kit:
Test Lead Set
3111024
TP74 Test Probe Set
AC285 Alligator Clip Set

59
ESA612
Users Manual

Accessories
Table 7 lists the available accessories for the Analyzer.

Table 7. Accessories
Item Fluke Biomedical Part Number

Test Leads with Retractable Sheath 1903307

Ground Pin Adapters 2242165

1210 - Option 3392119

Universal Snap to Banana Adapter 2462072

60
Electrical Safety Analyzer
Specifications

Specifications
Temperature
Operating ............................................................10 °C to 40 °C (50 °F to 104 °F)
Storage................................................................-20 °C to 60 °C (-4 °F to 140 °F)
Humidity .................................................................10 % to 90 % non-condensing
Altitude
120 V ac mains supply voltage ...........................5000 m
230 V ac mains supply voltage ...........................2000 m
Display....................................................................LCD display
Communications ...................................................USB device port for computer control
Modes of Operation...............................................Manual and remote
Power
120 Volt power outlet ..........................................90 to 132 V ac rms, 47 to 63 Hz, 20 A maximum
230 Volt power outlet ..........................................180 to 264 V ac rms, 47 to 63 Hz, 16 A maximum
Weight ....................................................................1.6 kg (3.5 lb)
Size .........................................................................28.5 cm x 17.6 cm x 8.4 cm (11.2 in x 6.9 in x 3.3 in)
Safety Standards
nd
CE .......................................................................IEC/EN61010-1 2 Edition; Pollution degree 2
CSA .....................................................................CAN/CSA-C22.2 No 61010-1; UL61010-1
Electromagnetic Compatibility Standards (EMC)
European EMC....................................................EN61326-1

61
ESA612
Users Manual

Detailed Specifications
Test Standard Selections........................................ ANSI/AAMI ES-1, IEC62353, IEC60601-1, and AN/NZS 3551
Voltage
Ranges (Mains voltage)...................................... 90.0 to 132.0 V ac rms
180.0 to 264.0 V ac rms
Range (Point-to-point voltage) ............................ 0.0 to 300.0 V ac rms
Accuracy ............................................................. ±(2 % of reading + 0.2 V)
Earth Resistance
Modes ................................................................. Two terminal
Test Current ........................................................ >200 mA ac
Range ................................................................. 0.000 to 2.000 Ω
Accuracy ............................................................. ±(2 % of reading + 0.015 Ω)
Equipment Current
Range ................................................................. 0.0 to 20.0 A ac rms
Accuracy ............................................................. ±(5 % of reading + (2 counts or 0.2A, whichever is greater))
Duty cycle ........................................................... 15 A to 20 A, 5 min. on/5 min. off
10 A to 15 A, 7 min. on/3 min. off
0 A to 10 A, continuous
Leakage Current
Modes*................................................................ AC+DC (True-rms)
AC only
DC only
* Modes: AC+DC, AC only, and DC only available for all leakages with exception of MAP
that are available in True-rms (shown as AC+DC)
Patient Load Selection........................................ AAMI ES1-1993 Fig. 1
IEC 60601: Fig. 15
Crest factor ......................................................... ≤3

62
Electrical Safety Analyzer
Detailed Specifications
Ranges................................................................0.0 to 199.9 μA
200 to 1999 μA
2.00 to 10.00 mA
Accuracy
DC to 1 kHz .....................................................±(1 % of reading + (1 μA or 1 LSD, whichever is greater))
1 to 100 kHz ....................................................±(2 % of reading + (1 μA or 1 LSD, whichever is greater))
100 kHz to 1 MHz............................................±(5 % of reading + (1 μA or 1 LSD, whichever is greater))
Mains on applied part test voltage ......................100 % ±5 % of Mains for AAMI, current limited to 1 mA ±25 % per AAMI
100 % ±5 % of Mains for 62353 current limited to 3.5 mA ±25 % per 62353
100 % ±5 % of Mains for 60601 current limited to 7.5 mA ±25 % per 60601
Differential leakage
Ranges................................................................10 to 199 μA
200 to 2000 μA
2.00 to 20.00 mA
Accuracy..............................................................±(10 % of reading + (2 counts or 20 μA, whichever is greater))
Insulation resistance
Ranges................................................................0.5 to 20.0 MΩ
20.0 to 100.0 MΩ
Accuracy
20 MΩ Range ..................................................±(2 % of reading + 0.2 MΩ)
100 MΩ Range ................................................±(7.5 % of reading + 0.2 MΩ)
Source test voltage .............................................500 V dc (+20 %, -0 %) 1.5 ±0.25 mA short-circuit current or 250 V dc selectable
Maximum load capacitance.................................1 μF

63
ESA612
Users Manual
ECG Performance Waveforms
Accuracy
Frequency ....................................................... ±2 %
Amplitude ........................................................ ±5 % of 2 Hz square wave only, fixed @ 1 mV Lead II configuration
Waveforms
ECG Complex ................................................. 30, 60, 120, 180, and 240 BPM
Ventricular Fibrillation
Square wave (50 % duty cycle) ...................... 0.125 Hz and 2 Hz
Sine wave ....................................................... 10, 40, 50, 60, and 100 Hz
Triangle wave.................................................. 2 Hz
Pulse (63 ms pulse width)............................... 30 BPM and 60 BPM

64

You might also like