Fluke ESA612 User Manual

ESA612

Electrical Safety Analyzer

Users Manual

March 2009, Rev. 1

© 2009 Fluke Corporation. All rights reserved. Specifications are subject to change without notice. All product names are trademarks of their respective companies.

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of original purchase. During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.

This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration of instruments is not covered under the warranty.

This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages, this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

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Contents (continued)

Notices

All Rights Reserved

♥ Copyright 2008, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language without the written permission of Fluke Biomedical.

Copyright Release

Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke Biomedical.

Unpacking and Inspection

Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.

Technical Support

For application support or answers to technical questions, either email [e-mail] or call 1-800- 648-7952 or 1-425- 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: [phone]

Email: [e-mail]

Everett Calibration Lab

Tel: 1-888-99 FLUKE (1-888-993-5853)

Email: [e-mail]

In Europe, Middle East, and Africa:

Eindhoven Calibration Lab

Tel: [phone]

Email: [e-mail]

In Asia:

Everett Calibration Lab

Tel: [phone]

Email: [e-mail]

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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List of Tables

Table	Title	Page
1.	Symbols.................................................................................................................................	2
2.	Top-Panel Controls and Connections....................................................................................	5
3.	Side and Top-Panel Connections..........................................................................................	7
4.	Schematic Abbreviations.......................................................................................................	17
5.	Test Names Based on Selected Standard.............................................................................	25
6.	Replaceable Parts .................................................................................................................	58
7.	Accessories ...........................................................................................................................	60

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List of Figures

Figure	Title	Page
1.	Front-Panel Controls and Connections .................................................................................	4
2.	Side and Top-Panel Connections..........................................................................................	6
3.	Analyzer Ready for Operation ...............................................................................................	8
4.	DUT Connections to the Analyzer .........................................................................................	9
5.	Leakage Current Menu..........................................................................................................	10
6.	Setup Menu ...........................................................................................................................	11
7.	Mains Voltage Test Menu......................................................................................................	13
8.	DUT Ground Resistance Measurement.................................................................................	14
9.	Ground Wire (Protective Earth) Resistance Measurement Connections...............................	16
10.	Ground Wire (Protective Earth) Resistance Measurement Schematic ..................................	18
11.	Insulation Resistance Measurement .....................................................................................	19
12.	Mains to Protective-Earth Insulation Resistance Test Schematic..........................................	20
13.	Applied Parts to Protective-Earth Insulation Test Schematic.................................................	21
14.	Mains to Applied Parts Insulation Test Schematic.................................................................	22
15.	Mains to Non-Earth Accessible Conductive Points Schematic ..............................................	23

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16.	Applied Parts to Non-Earth Conductive Points Schematic....................................................	24
17.	Leakage Current Main Menu ................................................................................................	26
18.	Earth Leakage Current Test Schematic ................................................................................	28
19.	Enclosure Leakage Current Test Schematic.........................................................................	30
20.	Lead-to-Ground (Patient) Leakage Current Test Schematic.................................................	32
21.	Applied Parts Connection Posts Display...............................................................................	33
22.	Lead-to-Lead (Patient Auxiliary) Leakage Current Test Schematic ......................................	34
23.	Lead Isolation (Mains On Applied Parts) Leakage Test Schematic ......................................	36
24.	Alternative Equipment Leakage Current Test Schematic......................................................	38
25.	Alternative Applied Part Leakage Test Schematic ................................................................	40
26.	Direct Equipment Leakage Test Schematic ..........................................................................	42
27.	Direct Applied Parts Leakage Current Test Schematic.........................................................	43
28.	Differential Leakage Current Test Schematic .......................................................................	45
29.	1210 Adapter Connections ...................................................................................................	47
30.	EGC Lead Connection with 1210 Adapter ............................................................................	49
31.	Point-To-Point Function Menu ..............................................................................................	50
32.	ECG Waveform Simulation Menu .........................................................................................	51
33.	ECG Monitor Connections ....................................................................................................	53
34.	Test Record ID Entry Screen ................................................................................................	54
35.	Fuse Access .........................................................................................................................	57

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Introduction

The Fluke Biomedical ESA612 Electrical Safety Analyzer (hereafter the Analyzer) is a full-featured, compact, portable analyzer, designed to verify the electrical safety of medical devices. The Analyzer tests to domestic (ANSI/AAMI ES1, NFPA 99) and international (IEC62353, AN/NZS 3551, and parts of IEC 60601-1) electrical-safety standards. The integrated ANSI/AAMI ES1 and IEC60601-1 patient loads are easily selectable.

The Analyzer performs the following tests:

•Line (Mains) voltage

•Ground Wire (or Protective Earth) Resistance

•Equipment current

Electrical Safety Analyzer

•Insulation resistance

•Ground (Earth) leakage

•Chassis (Enclosure) leakage

•Lead to Ground (Patient) and Lead to Lead (Patient Auxiliary) leakage

•Lead isolation (Mains on applied parts leakage)

•Differential leakage

•Direct equipment leakage

•Direct applied part leakage

•Alternative equipment leakage

•Alternative applied part patient leakage

•Point to point leakage, voltage, and resistance

•ECG simulation and performance waveforms

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	Table 1. Symbols
Symbol	Description
W	Important information; refer to manual.
X	Hazardous voltage
)	Conforms to relevant Canadian and US
	standards
;	Conforms to relevant Australian EMC
	requirements
P	Conforms to European Union directives
~	Do not dispose of this product as
	unsorted municipal waste. Go to Fluke’s
	website for recycling information.
	IEC Measurement Category II – CAT II
	equipment designed to protect against
CAT II	transients from energy-consuming
	equipment supplied from fixed
	installations.
˜	Accessible Functional Earth Terminal

Safety Information

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

XW Warning

To avoid possible electrical shock or personal injury, follow these guidelines:

•Use this Analyzer only in the manner specified by the manufacturer or the protection provided may be impaired.

•Read the Users Manual before operating the Analyzer.

•Do not connect the Analyzer to a patient or equipment connected to a patient. The Analyzer is intended for equipment evaluation only and should never be used in diagnostics, treatment or in any other capacity where the Analyzer would come in contact with a patient.

•Do not use the product in wet or damp locations, around explosive gases or dust.

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Electrical Safety Analyzer

Intended Use

•Inspect the Analyzer before using it. Do not use the Analyzer if abnormal conditions of any sort are noted (such as a faulty display, broken case, etc.)

•Inspect the test leads for damaged insulation or exposed metal. Check test lead continuity. Replace damaged leads before using the Analyzer.

•When testing, always be sure to keep your fingers behind the safety barriers on the test leads.

•Never open the Analyzer's case. Dangerous voltages are present. There are no user replaceable parts in the Analyzer.

•Have the Analyzer serviced only by qualified personnel.

•The Analyzer must be properly earthed. Only use a supply socket that has a protective earth contact. If there is any doubt as to the effectiveness of the supply socket earth, do not connect the Analyzer. Do not use a two-conductor adapter or extension cord; this will break the protective ground connection.

•Do not use the 15-20 A adapter to power devices rated in excess of 15 A. Doing so may overload the installation.

•Use extreme caution when working with voltages above 30 V.

•Use the proper terminals, functions and ranges for the test being performed.

•Do not touch metal parts of the device under test (DUT) during analysis. The DUT should be considered an electrical shock hazard when connected to the Analyzer as some tests involve high voltages, high currents, and/or the removal of DUT earth bond.

Intended Use

The Analyzer is intended for use by trained service technicians to perform periodic inspections on a wide range of medical equipment. The testing procedures are menu-driven, and simple to operate.

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Unpacking the Analyzer

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

•ESA612

•Getting Started Manual

•Users Manual CD

•Carrying case

•Power cord

•15 – 20 A Adapter (USA only)

•ESA USA Accessory Kit (USA, Australia, and Israel only)

•ESA EUR Accessory Kit

•Ansur demo CD

•Null Post Adapter

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

•Transfer cable

Instrument Familiarization

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

	1
9
	2
8	3
	4
	TEST
7	5
	6
	fis116.eps

Figure 1. Front-Panel Controls and Connections

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Instrument Familiarization

Table 2. Top-Panel Controls and Connections

	Item	Name	Description
			Controls the configuration of
		Equipment Outlet	the equipment outlet. Opens
			and closes the neutral and
	1	Configuration
			ground connection and
		Buttons
			reverses the polarity of the
			neutral and hot connection.
			Indicates when high voltage
		High Voltage	is applied to the
	2		ECG/Applied Parts posts or
		Indicator
			L1 and L2 of the Test
			Receptacle.
	3	Test Function	Selects the various Analyzer
		Buttons	test functions.
	4	Navigation Buttons	Cursor control buttons for
			navigating menus and lists.
	5	Test Button	Initiates selected tests.
	6	Save Button	Saves the measurement or
			ECG waveform to memory.
	7	Input Jacks	Test lead connectors.

	Item	Name	Description
		Nulling Jack	Connection for zeroing test
	8
			lead resistance.
			Keys F1 through F4 are used
			to select from a number of
	9	Function Softkeys	selections that appear in the
			LCD display above each
			function softkey.

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

R RA
F LL
L LA
N RL
C1	V1
TEST	7
	2
	4
1
3	8
	5
	6
	fis110.eps

Figure 2. Side and Top-Panel Connections

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Electrical Safety Analyzer

Instrument Familiarization

Table 3. Side and Top-Panel Connections

Item

Name

1 Equipment Outlet

2

USB Device Port (B-style connector)

3Fuse Access Door

4Tilt Stand

5AC Power Switch

6Power Input Connector

7ECG/Applied Parts Jacks

8Banana Jack to ECG Adapter

Description

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

Digital connection for controlling the Analyzer from a PC or instrument controller.

Covers the equipment outlet fuses.

Support for holding the Analyzer in a tilted position.

Turns ac power on and off.

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

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

Adapter for connecting ECG snap leads to the Analyzer.

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Connecting to Line Power	Turning the Analyzer On
XWWarning	Note

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

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

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

Connecting a DUT to the Analyzer

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

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

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

fis101.jpg

Figure 3. Analyzer Ready for Operation

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Electrical Safety Analyzer

Turning the Analyzer On

To protective earth or any exposed conductive surface on the enclosure

R RA

F LL

L LA

N RL

C1

V1

TEST

fis113.eps

Figure 4. DUT Connections to the Analyzer

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

Accessing the Analyzer’s Functions

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

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

These icons indicate the use of Eand Fto select an applied part.

fis102.jpg

Figure 5. Leakage Current Menu

The three buttons along the right side of the display (PND) control the wiring of the Analyzer’s test receptacle for some electrical tests. The present state of these three buttons is displayed along the right edge of the display whenever these controls are active.

Figure 5 shows polarity is settable between normal, reversed, and off. Neutral is also settable to closed or open. Earth condition is not displayed, which indicates it can not be changed. However, earth is internally opened during this test.

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