Fluke ESA612
Fluke ESA612
Users Manual
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.
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:
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 or
In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4606
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
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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
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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
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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List of Figures
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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
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˜ Accessible Functional Earth Terminal • Do not use the product in wet or damp
locations, around explosive gases or dust.
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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.
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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.
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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
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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)
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.
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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.
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Electrical Safety Analyzer
Turning the Analyzer On
LL
F
LA
L
RL
N
V1
C1
TE
ST
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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.
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Electrical Safety Analyzer
Setting Up the Analyzer
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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.
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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
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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
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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.
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LL
F
LA
L
RL
N
V1
C1
TE
ST
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Electrical Safety Analyzer
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Table 4. Schematic Abbreviations
Abbreviation Meaning
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APPLIED
PART
DUT_L2
EARTH
OPEN
DUT_PE FE
PE
CONDUCTIVE PART
MD
TEST LEAD
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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.
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APPLIED
PART
DUT_L2
MD
DUT_PE
FE
CONDUCTIVE PART
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Electrical Safety Analyzer
Performing Electrical Safety Tests
APPLIED
PART
DUT_L2
DUT_PE
FE
MD CONDUCTIVE PART
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APPLIED
PART
DUT_L2
MD
DUT_PE
FE
CONDUCTIVE PART
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Electrical Safety Analyzer
Performing Electrical Safety Tests
APPLIED
PART
DUT_L2
MD
DUT_PE
FE
CONDUCTIVE PART
TEST
LEAD
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APPLIED
PART
DUT_L2
DUT_PE
FE
CONDUCTIVE PART
TEST
LEAD
MD
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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
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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
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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.
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L1
APPLIED
PART
MAINS L2
OPEN DUT_L2
L2
REV
POL
EARTH
OPEN
DUT_PE
FE
CONDUCTIVE PART
MD
PE
APPLIED PART
OPEN
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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
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L1
APPLIED
PART
MAINS
L2
OPEN DUT_L2
L2
EARTH
OPEN
DUT_PE
FE
CONDUCTIVE PART
MD TEST LEAD
PE APPLIED PART
OPEN
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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.
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CONDUCTIVE PART
LEAD SELECT
MD
PE
LEAD GND
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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
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MD
- LEAD
GROUND LEAD
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Electrical Safety Analyzer
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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.
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ESA612
Users Manual
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.
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ESA612
Users Manual
APPLIED
PART
DUT_L2
DUT_PE
FE
CONDUCTIVE PART
PE TEST
OPEN LEAD
MD
faw22.eps
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.
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ESA612
Users Manual
APPLIED
PART
AP2
DUT_L2
DUT_PE
FE
CONDUCTIVE PART
TEST
LEAD
MD
faw23.eps
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.
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ESA612
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L1
APPLIED
PART
MAINS L2
OPEN DUT_L2
L2
REV
POL
PE
OPEN
DUT_PE
FE
CONDUCTIVE PART
MD
TEST
LEAD
faw24.eps
42
Electrical Safety Analyzer
Performing Electrical Safety Tests
L2
REV
POL
DUT_PE
FE
CONDUCTIVE PART
MD
faw25.eps
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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
L1
APPLIED
MD PART
MAINS L2
OPEN DUT_L2
L2
REV
POL
FE
EARTH
OPEN
DUT_PE
PE
CONDUCTIVE PART
TEST
LEAD
faw32.eps
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ESA612
Users Manual
46
Electrical Safety Analyzer
Using the 1210 Adapter
Defibrillator/Pacer ESA612
DEFIB
OFF
PACER
1210
fis120.eps
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ESA612
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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
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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
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
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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
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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
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
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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
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ESA612
Users Manual
Replaceable Parts
Table 6 lists the replaceable parts for the Analyzer.
USA 2238680
UK 2238596
Australia 2238603
Europe 2238615
Power Cord
France/Belgium 2238615
Thailand 2238644
Israel 2434122
Switzerland 3379149
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Electrical Safety Analyzer
Replaceable Parts
Table 6. Replaceable Parts (cont.)
Item Fluke Biomedical Part Number
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ESA612
Users Manual
Accessories
Table 7 lists the available accessories for the Analyzer.
Table 7. Accessories
Item Fluke Biomedical Part Number
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
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ESA612
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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
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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
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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