ESA615
Electrical Safety Analyzer
Getting Started Manual
PN 4105845
February 2012, Rev. 2, 3/13
© 2012, 2013 Fluke Corporation. All rights reserved.Specifications are subject to change without notice.
All product names are trademarks of their respective companies.
Warranty and Product Support
Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of
original purchase OR two years if at the end of your first year you send the instrument to a Fluke Biomedical service center
for calibration. You will be charged our customary fee for such calibration. During the warranty period, we will repair or at our
option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to
Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if
the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized
Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE
EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.
This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration
of instruments is not covered under the warranty.
This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since
some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages,
this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or
other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.
7/07
Notices
All Rights Reserved
 Copyright 2012, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or
translated into any language without the written permission of Fluke Biomedical.
Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service
training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke
Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking
the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking
instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or
broken parts, dents, or scratches.
Technical Support
For application support or answers to technical questions, either email techservices@flukebiomedical.com or call 1-800- 850-4608 or 1-440248-9300. In Europe, email techsupport.emea@flukebiomedical.com or call +31-40-2675314.
Claims
Our routine method of shipment is via common carrier, FOB origin. Upon delivery, if physical damage is found, retain all packing materials in
their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not
operate within specifications, or if there are any other problems not caused by shipping damage, please contact Fluke Biomedical or your local
sales representative.
Returns and Repairs
Return Procedure
All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an
instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that
you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are
received in damaged condition due to improper packaging or handling.
Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:

Use a double–walled carton of sufficient strength for the weight being shipped.

Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting parts.

Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument.
Returns for partial refund/credit:
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order
Entry Group at 1-440-498-2560.
Repair and calibration:
To find the nearest service center, go to www.flukebiomedical.com/service or
In the U.S.A.:
Cleveland Calibration Lab
Tel: 1-800-850-4608 x2564
Email: globalcal@flukebiomedical.com
Everett Calibration Lab
Tel: 1-888-99 FLUKE (1-888-993-5853)
Email: service.status@fluke.com
In Europe, Middle East, and Africa:
Eindhoven Calibration Lab
Tel: +31-40-2675300
Email: servicedesk@fluke.nl
In Asia:
Everett Calibration Lab
Tel: +425-446-6945
Email: service.international@fluke.com
To ensure the accuracy of the Product is maintained at a high level, Fluke Biomedical recommends the product be calibrated at least once
every 12 months. Calibration must be done by qualified personnel. Contact your local Fluke Biomedical representative for calibration.
Certification
This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was
shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for
which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.
WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper
operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.
Restrictions and Liabilities
Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the
information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical
for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.
Manufacturing Location
The ESA615 Electrical Safety Analyzer is manufactured at Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.
Table of Contents
Title
Page
Introduction .................................................................................................................... 1
Intended Use ..................................................................................................................3
Safety Information .......................................................................................................... 3
Unpack the Product ........................................................................................................ 5
Instrument Familiarization .............................................................................................. 6
How to Hold the Product ................................................................................................ 10
How to Connect to Line Power ....................................................................................... 10
How to Connect a DUT to the Product ........................................................................... 11
How to Turn On the Product ........................................................................................... 11
How to Set the Display Contrast ................................................................................ 11
How to Set the Language .......................................................................................... 12
What to Do Next ............................................................................................................. 14
Maintenance ...................................................................................................................14
Fuse Test and Fuse Replacement............................................................................. 14
How to Clean the Product .......................................................................................... 15
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ESA615
Getting Started Manual
Replaceable Parts ......................................................................................................... 16
Accessories ................................................................................................................... 18
Specifications ................................................................................................................ 18
Detailed Specifications .................................................................................................. 20
ii
List of Tables
Table
1.
2.
3.
4.
5.
Title
Page
Symbols.................................................................................................................................
Top-Panel Controls and Connections ....................................................................................
Side and Top-Panel Connections ..........................................................................................
Replaceable Parts .................................................................................................................
Accessories ...........................................................................................................................
iii
2
7
9
16
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ESA615
Getting Started Manual
iv
List of Figures
Figure
1.
2.
3.
4.
5.
6.
Title
Page
Front-Panel Controls and Connections .................................................................................
Side and Top-Panel Connections ..........................................................................................
Product Handle ......................................................................................................................
Product Ready for Operation .................................................................................................
DUT Connected to the Analyzer ............................................................................................
Fuse Access ..........................................................................................................................
v
6
8
10
11
13
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ESA615
Getting Started Manual
vi
Electrical Safety Analyzer
Introduction
 Warning
To prevent possible electrical shock, fire, or
personal injury, read all “safety information”
before you use the Product.
The Fluke Biomedical ESA615 Electrical Safety Analyzer
(the Product) is a full-featured, compact, portable
analyzer, designed to verify the electrical safety of
medical devices. The Product tests to domestic
(ANSI/AAMI ES1, NFPA 99) and international (IEC62353,
AN/NZS 3551, and parts of IEC 60601-1) electrical safety
standards. The Product simulates ECG to do
performance tests on ECG monitors.
The integrated ANSI/AAMI ES1 and IEC60601-1 patient
loads are easily selectable.
The Product does these tests:
•
•
•
•
•
•
•
•
•
Line (Mains) voltage
Ground Wire (Protective Earth) resistance
Equipment current
Insulation resistance
Ground (Earth) leakage
Chassis (Enclosure) leakage
Lead to Ground (Patient) and Lead to Lead (Patient
Auxiliary) leakage
Lead isolation (Mains on applied parts leakage)
Differential leakage
1
ESA615
Getting Started Manual
•
Direct equipment leakage
•
Direct applied part leakage
•
Alternative equipment leakage
•
Alternative applied part patient leakage
•
Point to point leakage, voltage, and resistance
•
ECG simulation and performance waveforms
Table 1 is a list of the symbols used on the Product and in
this manual.
Table 1. Symbols
2
Symbol
Description

Important information. Refer to manual.

Hazardous voltage.

Conforms to relevant Canadian and US
standards.

Conforms to relevant Australian EMC
requirements.

Conforms to European Union directives.

Accessible Functional Earth Terminal.
Symbol
Description

This product complies with the WEEE
Directive (2002/96/EC) marking
requirements. The affixed label indicates
that you must not discard this
electrical/electronic product in domestic
household waste. Product Category:
With reference to the equipment types in
the WEEE Directive Annex I, this product
is classed as category 9 "Monitoring and
Control Instrumentation" product. Do not
dispose of this product as unsorted
municipal waste. Go to Fluke’s website
for recycling information.
CAT II
IEC Measurement Category II – CAT II
equipment designed to protect against
transients from energy-consuming
equipment supplied from fixed
installations.
Electrical Safety Analyzer
Intended Use
Intended Use
Safety Information
The Product is an electronic signal source and
measurement device for verifying the electrical safety of
medical devices. The Product also provides ECG
simulation and performance waveforms to verify patient
monitors are performing within their operating
specifications.
In this manual, a Warning identifies conditions and
procedures that are dangerous to the user. A Caution
identifies conditions and procedures that can cause
damage to the Product or the equipment under test.
 Warning
The Product provides the following function categories:
To prevent possible electrical shock, fire, or
personal injury, follow these guidelines:
•
ECG Functions
•
•
ECG-Performance Testing
Use the Product only as specified, or the
protection supplied by the Product can
be compromised.
•
Use only the mains power cord and
connector approved for the voltage and
plug configuration in your country and
rated for the Product.
•
Do not connect the Product to a patient
or equipment connected to a patient. The
Product is intended for equipment
evaluation only. The Product must not be
used in diagnostics, treatment, or other
capacities where the Product could
touch a patient.
The intended user is a trained biomedical equipment
technician who performs periodic preventative
maintenance checks on patient monitors in service. Users
can be associated with hospitals, clinics, original
equipment manufacturers and independent service
companies that repair and service medical equipment.
The end user is an individual, trained in medical
instrumentation technology.
This Product is intended to be used in the laboratory
environment, outside of the patient care area, and is not
intended for use on patients, or to test devices while
connected to patients. This Product is not intended to be
used to calibrate medical equipment. It is intended for
over the counter use.
3
ESA615
Getting Started Manual
•
4
Do not use test leads if they are
damaged. Examine the test leads for
damaged insulation, exposed metal, or if
the wear indicator shows. Check test lead
continuity.
•
Examine the case before you use the
Product. Look for cracks or missing
plastic. Carefully look at the insulation
around the terminals.
•
Make sure the ground conductor in the
mains power cord is connected to a
protective earth ground. Disruption of the
protective earth could put voltage on the
chassis that could cause death.
•
Do not use an extension cord or adapter
plug.
•
Do not use and disable the Product if it is
damaged.
•
Do not use the Product around explosive
gas, vapor, or in damp or wet
environments.
•
Do not touch voltages > 30 V ac rms, 42 V
ac peak, or 60 V dc.
•
Measure a known voltage first to make
sure that the Product operates correctly.
•
Do not apply more than the rated voltage,
between the terminals or between each
terminal and earth ground.
•
Remove the null post adapter from the
∅/Null jack after a test lead zero is
performed. The ∅/Null jack becomes
potentially hazardous during some of the
test conditions. Use only cables with
correct voltage ratings.
•
Remove all probes, test leads, and
accessories that are not necessary for
the measurement.
•
Keep fingers behind the finger guards on
the probes.
•
Connect the common test lead before the
live test lead and remove the live test lead
before the common test lead.
•
Use only current probes, test leads, and
adapters supplied with the Product.
•
Do not use the 15-20 A adapter to supply
power to devices rated more than 15 A.
This can overload the installation.
Electrical Safety Analyzer
Unpack the Product
•
Replace the mains power cord if the
insulation is damaged or if the insulation
shows signs of wear.
Unpack the Product
•
Comply with local and national safety
codes. Use personal protective
equipment (approved rubber gloves, face
protection, and flame-resistant clothes) to
prevent shock and arc blast injury where
hazardous live conductors are exposed.
•
Do not touch metal parts of the device
under test (DUT) while you do a test.
Some tests apply high voltage and high
current to the DUT with the DUT earth
connection open or closed.
•
•
•
•
•
•
•
Carefully unpack all items from the box and check that you
have these items:
•
•
•
•
ESA615
Getting Started Manual
Users Manual CD
Carrying Case
Power Cord
15 – 20 A Adapter (USA only)
ESA USA Accessory Kit (USA, Australia, and Israel
only) or ESA EUR Accessory Kit
Ansur Demo CD
Null Post Adapter
5-to-5 Banana to ECG Adapter (BJ2ECG)
USB Transfer Cable
5
ESA615
Getting Started Manual
Instrument Familiarization
Figure 1 and Table 2 show the front-panel controls and connections of the Product.
1
9
2
8
3
4
5
7
6
gtv116.eps
Figure 1. Front-Panel Controls and Connections
6
Electrical Safety Analyzer
Instrument Familiarization
Table 2. Top-Panel Controls and Connections
Item
Name
Description
1
Equipment Outlet
Configuration Buttons
Controls the configuration of the equipment outlet. Opens and closes the neutral and
ground connection and reverses the polarity of the neutral and hot connection.
2
High Voltage Indicator
Illuminates when high voltage is applied to the ECG/Applied Parts posts or L1 and
L2 of the Test Receptacle.
3
Test Function Buttons
Selects the Product test functions.
4
Navigation Buttons
Cursor control buttons for navigating menus and lists.
5
Test Button
Starts selected tests.
6
Enter Button
Sets the highlighted function.
7
Input Jacks
Test lead connectors.
8
Nulling Jack
Connection to zero test lead resistance.
9
Function Softkeys
Keys F1 through F4 are used to select from a number of selections that show in the
LCD display above each function softkey.
7
ESA615
Getting Started Manual
Figure 2 and Table 3 describe the side and top-panel connections of the Product.
RA
R
LL
F
LA
L
RL
N
V1
C1
9
3
2
5
1
4
10
6
7
8
gtv110.eps
Figure 2. Side and Top-Panel Connections
8
Electrical Safety Analyzer
Instrument Familiarization
Table 3. Side and Top-Panel Connections
Item
Name
Description
1
Equipment Outlet
Equipment outlet, specified to the version of the Product, which supplies a DUT
connection.
2
USB A Controller Port
For external keyboard or barcode reader.
USB Device Port
Digital connection to control the Product from a PC or instrument controller.
3
(Mini B-style connector)
4
Fuse Access Door
Equipment outlet fuse access.
5
Tilt Stand
Holds the Product in a tilted position.
6
SD Card Slot
SD Memory Card access
7
AC Power Switch
Turns ac power on and off.
8
Power Input Connector
A grounded male three-prong (IEC 60320 C19) connector that accepts the
line-power cord.
9
ECG/Applied Parts Jacks
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.
10
Banana Jack to ECG Adapter
Adapter to connect ECG snap leads to the Product.
9
ESA615
Getting Started Manual
How to Connect to Line Power
How to Hold the Product
When you move the Product, use the handle on the
bottom case to hold it. See Figure 3.
Warning
To prevent possible electrical shock, fire, or
personal injury:
gtv122.eps
Figure 3. Product Handle
10
•
Do not use an extension cord or adapter
plug.
•
Make sure the ground conductor in the
mains power cord is connected to a
protective earth ground. Disruption of
the protective earth could put voltage on
the chassis that could cause death.
•
Replace the mains power cord if the
insulation is damaged or if the insulation
shows signs of wear.
•
Use only the mains power cord and
connector approved for the voltage and
plug configuration in your country and
rated for the Product.
Electrical Safety Analyzer
How to Connect a DUT to the Product
The Product is intended for use with single-phase,
grounded power. It is not intended for dual, split-phase or
three-phase power configurations. It can be used with a
power system that supplies the correct voltages for
single-phase and is grounded, or is an isolated power
system.
Use the power cord for your country mains supply that is
not more than the voltage or power rating of the product.
Connect the cord into the power input connector and then
to the mains outlet.
How to Set the Display Contrast
There are two procedures to set the display contrast.
From the Test Sequence start-up menu or through the
setup menu.
When the Product shows the start-up menu shown in
Figure 4, push  or  to increase or decrease the
display contrast respectively. Push the Done softkey to
exit contrast setup.
How to Connect a DUT to the Product
You can connect a Device Under Test (DUT) a number of
different ways for a full electrical safety test. Figure 5
shows a DUT connected to the test receptacle, applied
parts posts, and a connection to the enclosure or
protective earth ground of the DUT.
How to Turn On the Product
Note
To make sure the high voltage indicator works,
look for it to illuminate at the power-up.
Push the power switch found on the left-side panel so the
“I” side of the ac power switch is down. The Product does
a series of self tests and then shows the message in
Figure 4 when the self test has completed successfully.
gtv125.bmp
Figure 4. Product Ready for Operation
To adjust the contrast through the setup menu:
1.
From the setup menu, push the Instrument Setup
softkey.
2.
Push the Display Contrast softkey.
11
ESA615
Getting Started Manual
3.
Push  or  to increase or decrease the display
contrast respectively.
1.
Push .
2.
From the setup menu, push the Instrument Setup
softkey.
How to Set the Language
3.
The Product can display data in English, French,
German, Spanish, Italian, or Portuguese. To change the
language:
Push  or  until the Language variable is
highlighted.
4.
Push .
5.
Push  or  to highlight one of the languages.
6.
Push .
4.
12
Push the Done softkey to exit contrast setup.
Electrical Safety Analyzer
How to Turn On the Product
To protective earth or
any exposed conductive
surface on the enclosure
Connect ESA615
to grounded
mains socket.
RA
R
LL
F
LA
L
RL
N
V1
C1
Connect the DUT ac power cord to the
equipment outlet on the Analyzer
gtv113.eps
Figure 5. DUT Connections to the Product
13
ESA615
Getting Started Manual
What to Do Next
For more information on how to use the Product, refer to
the ESA615 Users Manual contained on the Product CD.
The Product is a calibrated measurement instrument. Use
the necessary precautions to prevent mechanical abuse
that could change the calibrated adjustments.
Fuse Test and Fuse Replacement
Maintenance
 Warning
 Warning
To prevent electric shock, remove all power
cords and test leads from the Product before
opening the fuse door.
To prevent possible electrical shock, fire, or
personal injury:
14
•
Have an approved technician repair the
Product.
•
Use only specified replacement fuses.
•
Use only specified replacement parts.
•
Remove the input signals before you
clean the Product.
•
Disconnect the mains power cord before
you remove the Product covers.
•
Turn the Product off and remove the
mains power cord. Stop for two minutes
to let the power assemblies discharge
before you open the fuse door.
•
Do not operate the Product with covers
removed or the case open. Hazardous
voltage exposure is possible.
For electrical protection of the equipment outlet, the
Product uses two fuses, one in the live (L1) line and one
in the neutral (L2) line. To do a fuse test:
1.
Turn the Product so the case bottom is up. See
Figure 6.
2.
Flip up the tilt stand.
3.
Remove the screw in the fuse door with a #2 Phillips
head screwdriver and lift the fuse door from the
Product.
4.
Remove the two fuses from the Product.
Electrical Safety Analyzer
Maintenance
How to Clean the Product
 Warning
To prevent electric shock, do not clean the
Product plugged into mains or attached to a
DUT.
F1 - F2
 Caution
Do not pour fluid onto the Product surface.
Fluid in the electrical circuitry can cause the
Product to fail.
 Caution
Do not use spray cleaners on the Product.
This can cause fluid to leak into the Product
and damage electronic components.
gtv111.eps
Figure 6. Fuse Access
5.
Using a multimeter, measure the continuity of each
fuse.
If a fuse does not show continuity, replace the fuse(s)
with a fuse of the same current and voltage rating.
Applicable fuse ratings are posted on the case
bottom label of the Product. Table 4 is a list of
available fuses with Fluke Biomedical part numbers.
6.
Clean the Product occasionally with a damp cloth and
weak detergent. Try to prevent the entrance of liquids.
Clean the adapter cables with the same precautions.
Examine them for damage and deterioration of the
insulation. Examine the connections for integrity before
each use.
Reinstall the fuse door and secure it with the screw.
15
ESA615
Getting Started Manual
Replaceable Parts
Table 4 is a list of replaceable parts for the Product.
Table 4. Replaceable Parts
Item
Fluke Biomedical Part Number
ESA615 Getting Started Manual
4105845
ESA615 Users Manual CD
4105850
Power Cord
USA/Japan
2238680
UK
2238596
Australia/China
2238603
Europe
2238615
France/Belgium
2238615
Thailand
2238644
Israel
2434122
Switzerland
3379149
Brazil
3841358
USA to Brazil Outlet Adapter
4151242
Null Post Adapter
3326842
Ansur, CD with demo version
2795488
16
Electrical Safety Analyzer
Replaceable Parts
Table 4. Replaceable Parts (cont.)
Item
Fluke Biomedical Part Number
5-to-5 Banana jack to ECG (BJ2ECG) adapter
3359538
Carrying Case
2248650
Data Transfer Cable
4034393
Fuse
USA-115, Japan
T20A 250V Fuse (Time Lag), 1¼ in x ¼ in
2183691
Australia, China,
Switzerland
T10A 250V Fuse (Time Lag), 1¼ in x ¼ in
109298
Europe, UK, USA-220,
France/Belgium, Thailand,
Brazil, Israel
T16A 250V Fuse (Time Lag), 6.3 mm x 32 mm
3321245
15 – 20 A Adapter
2195732
ESA USA/AUS/ISR Accessory Kit:
Test Lead Set
TP1 Test Probe Set
AC285 Alligator Clip Set
3111008
ESA EUR Accessory Kit:
Test Lead Set
TP74 Test Probe Set
AC285 Alligator Clip Set
3111024
 To ensure safety, use exact replacement only.
17
ESA615
Getting Started Manual
Accessories
Table 5 is a list of available accessories for the Product.
Table 5. Accessories
Item
Fluke Biomedical Part Number
Test Leads with Retractable Sheath
1903307
Ground Pin Adapters
2242165
1–to–10 ECG Adapter
3392119
Universal Snap to Banana Adapter (10/pack)
2462072
Ultrasound Test Cable Adapter
3472633
USB Wireless Dongle
3341333
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
100 V/115 V ac mains supply voltage ................. 5000 m
230 V ac mains supply voltage ........................... 2000 m
Display ................................................................... LCD display
Communications
USB Device Upstream Port ................................ Mini-B connector for control by a computer
18
Electrical Safety Analyzer
Specifications
USB Host Controller Port .................................... Type A, 5 V output, 0.5 A max load. Connector for keyboard and barcode reader
Wireless............................................................... IEEE 802.15.4 for control by a computer
Modes of Operation............................................... Manual and remote
Power
100 V/115 V power outlet .................................... 90 to 132 V ac rms, 47 to 63 Hz, 20 A maximum
230 V 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
rd
CE ....................................................................... IEC/EN61010-1 3 Edition; Pollution degree 2, CAT II
CSA ..................................................................... CAN/CSA-C22.2 No 61010-1; UL61010-1
Electromagnetic Compatibility Standards (EMC)
European EMC .................................................... EN61326-1
IP Rating ................................................................. 20
19
ESA615
Getting Started Manual
Detailed Specifications
Test Standard Selections ........................................ ANSI/AAMI ES-1, IEC62353, IEC60601-1, and AN/NZS 3551
Voltage
Ranges (Mains voltage) ...................................... 90.0 V to 132.0 V ac rms
180.0 V to 264.0 V ac rms
Range (Point-to-point voltage)
5000 m ............................................................ 0.0 V to ≤150 V ac rms
2000 m ............................................................ 0.0 V to ≤300.0 V ac rms
Accuracy ............................................................. ±(2 % of reading + 0.2 V)
Earth Resistance
Modes ................................................................. 2-Wire
Test Current ........................................................ >200 mA ac
Range ................................................................. 0.000 Ω to 2.000 Ω
Accuracy ............................................................. ±(2 % of reading + 0.015 Ω)
Equipment Current
Range ................................................................. 0.0 A to 20.0 A ac rms
Accuracy ............................................................. ±(5 % of reading + (2 counts or 0.2 A, 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
* For tests that do not use MAP voltage, AC+DC, AC ONLY, and DC ONLY modes are
available for all leakages. MAP voltages are available only in True-rms (shown as
AC+DC)
20
Electrical Safety Analyzer
Detailed Specifications
Patient Load Selection ........................................ AAMI ES1-1993 Fig. 1
IEC 60601: Fig. 15
Crest factor .......................................................... ≤3
Ranges ................................................................ 0.0 μA to 199.9 μA
200 μA to 1999 μA
2.00 mA to 10.00 mA
Accuracy
DC to 1 kHz ..................................................... ±(1 % of reading + (1 μA or 1 LSD, whichever is greater))
1 kHz to 100 kHz ............................................. ±(2 % of reading + (1 μA or 1 LSD, whichever is greater))
1 kHz to 5 kHz (current > 1.6 mA) ................... ±(4 % 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))
Note
Accuracy for Isolation, MAP, Direct AP, Alternative AP, and Alternative Equipment leakage tests all ranges are:
•
At 120 V ac + (2.5 μA or 1 LSD, whichever is greater)
•
At 230 V ac additional ± 3.0 % and + (2.5 μA or 1 LSD, whichever is greater)
For Alternative equipment, Alternative AP, and Direct AP leakage tests, the leakage values are compensated for
nominal mains as per 62353. Therefore, the accuracy specified for other leakages is not applicable.
Mains on applied part test voltage ...................... 100 % ±7 % of Mains for AAMI, current limited to 1 mA ±25 % per AAMI
100 % ±7 % of Mains for IEC 62353 current limited to 3.5 mA ±25 % per IEC 62353
100 % ±7 % of Mains for IEC 60601-1 current limited to 7.5 mA ±25 % per IEC 60601-1
Differential leakage
Ranges ................................................................ 75 μA to 199 μA
200 μA to 1999 μA
2.00 mA to 20.00 mA
Accuracy.............................................................. ±(10 % of reading + (2 counts or 20 μA, whichever is greater))
21
ESA615
Getting Started Manual
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 or 250 V dc (+20 %, -0 %) 2.0 ±0.25 mA short-circuit current
Maximum load capacitance ................................ 1 μF
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
22
Electrical Safety Analyzer
Factory-Supplied Test Sequences
rd
60601 3 Edition Patient Monitor
rd
60601 3 Edition Defibrillator
rd
60601 3 Edition Infusion Pump
rd
60601 3 Edition Ultrasound Device
rd
60601 3 Edition Generic Device
rd
60601 3 Edition System
62353-Alt. Patient Monitor
62353-Alt. Defibrillator
62353-Alt. Infusion Pump
62353-Alt. Ultrasound Device
62353-Alt Generic Device
NFPA99 Patient Monitor
NFPA99 Defibrillator
NFPA99 Infusion Pump
NFPA99 Ultrasound Device
NFPA99 Generic Device
ANSI/AAMI ES-1 Patient Monitor
ANSI/AAMI ES-1 Defibrillator
ANSI/AAMI ES-1 Infusion Pump
ANSI/AAMI ES-1 Ultrasound Device
ANSI/AAMI ES-1 Generic Device
23
ESA615
Getting Started Manual
24
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