Technical data

ESA615
Electrical Safety Analyzer
The ESA615 Electrical Safety Analyzer brings
fast and simple automated testing to a portable
analyzer for healthcare technology management
professionals that perform electrical safety test-
ing on medical equipment both in the field and in
facilities. Whether it is simple testing or compre-
hensive analysis, the ESA615 can do it all. This
multifaceted device performs all primary electri-
cal safety tests, including line (mains) voltage,
ground wire (protective earth) resistance, insula-
tion resistance, device current, and lead (patient)
leakage tests. It also offers ECG simulation and
point–to-point voltage, leakage, and resistance
tests. Versatile to global electrical safety stan-
dards of choice, ESA615 tests to ANSI/AAMI ES1,
NFPA-99, IEC62353 (VDE751) IEC60601-1 (2nd
and 3rd editions) and AS/NZS 3551. The ESA615
is an all-in-one solution with a safety analyzer and
ECG simulator in a single test instrument.

Key features
•• Portable, ergonomic design with an integrated •• 20 A at 120 V current capability
handle and tilt stand •• Replaceable mains fuses keep your unit in the
•• On-board automation with automated test field and out of the repair shop
sequences for easy compliance to key global •• Custom language selections include:
electrical safety standards (ANSI/AAMI ES-1 English, French, German, Spanish, Italian
(NFPA-99), IEC62353 (VDE751), IEC60601-1 2nd and Portuguese
and 3rd editions, and AS/NZS 3551) •• Rigorously tested for rugged field applications
•• User-friendly interface for streamlined testing with CE and CSA in addition to Fluke-quality-
•• ECG waveform tests and dual-lead measure- ruggedness for long-term reliability
ments combine the functionality of a simulator •• Two-year extended warranty (no-cost available
and safety analyzer in a single test tool after first-year calibration at any authorized
•• Five applied parts jacks and easy ECG snap Fluke Biomedical Service Center)
connection; optional expander box for up to •• Global support network delivering prompt
12-lead ECG testing service and peace of mind to Fluke Biomedical
•• Easy data entry through barcode external customers worldwide
keyboard or on-board keypad
•• Wireless communication plus removable
memory card for fast and convenient data
storage and exchange
Automated: Pre-set templates allow you to test to Portable: The ESA615 is a small, lightweight
the global standard of your choices at the push of analyzer with an integrated handle to carry from
a button. Let the unit guide you through the test place to place for on-the-go field service. It is de-
steps quickly and accurately in three simple steps: signed for operation in tight spaces, and is easy
to fit on any cart. A light, protective carrying case
1. Select the test sequence corresponding to your makes it easy to store and transport.
standard of choice
Simple: A push-button interface allows quick
2. Initiate the automated test sequence. access to highly-comprehensive functions and
features, and an intuitive interface guides the
3. Store the results on-board or wirelessly export
user through tests. The ESA615 features a large
to your PC in seconds.
display for clear indication of available functions,
It is that easy. The automated test sequences set-up criteria, device under test receptacle
are easily customized to suit individual testing conditions, and test results. Data can be entered
requirements. quickly with a plug–and-play keyboard, barcode
scanner and/or on-board data entry interface.
Data archival is fast and simple with wireless
communication or through a removable memory
card with capacity for thousands of test results.
Specifications
Voltage
Range (mains voltage) 90.0 V ac rms to 132.0 V ac rms
180.0 V ac rms to 264.0 V ac rms
Range (point-to-point voltage) 0.0 V ac rms to 300.0 V ac rms
Accuracy ± (2 % of reading + 0.2 V)
Voltage tests Mains and point to point
Earth resistance
Modes Two-Wire
Test current/ranges/accuracy > 200 mA ac 0.000 Ω to 2.000 Ω ± (2 % of reading +
0.015 Ω)
Resistance tests Earth resistance and point to point
Equipment current
Mode AC rms
Range/Accuracy 0.0 A to 20.0 A ± (5 % of reading + (2 counts or 0.2 A, which-
ever 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 are available in all leakage tests with the exception of MAP leakages that are available only in
true-rms
Patient load selection (input AAMI ES1-1993 Fig.1
impedance) 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

2 Fluke Biomedical ESA615 Electrical Safety Analyzer

Frequency response/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 ± (4 % of reading + (1 μA or 1 LSD, whichever is
(current > 1.6 mA) greater))
100 kHz to 1 MHz ± (5 % of reading + (1 μA or 1 LSD, whichever is
greater))
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.
Leakage tests Ground wire (earth)
Chassis (enclosure)
Lead to ground (patient)
Lead to lead (patient auxillary)
Lead isolation (mains on applied part)
Direct equipment
Direct applied part
Alternative equipment
Alternative applied part
Point to point
Mains on applied part 100 % ± 7 % of Mains for AAMI, current limited to 1 mA ± 25 % per
test voltage 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 μ A 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))
Insulation resistance
Ranges/accuracy 0.5 MΩ to 20.0 MΩ ± (2 % of reading + 0.2 MΩ)
20.0 MΩ to 100.0 MΩ ± (7.5 % of reading + 0.2 MΩ)
Source test voltage 500 V dc or 250 V dc (+20 %, -0 %)
2.0 ± 0.25 mA short-circuit current
Insulation resistance tests Mains-PE, AP-PE, Mains-PE, Mains-NE (non-earthed accessible
conductive part) and AP-NE (non-earthed accessible conductive part)

3 Fluke Biomedical ESA615 Electrical Safety Analyzer

ECG performance waveforms
Accuracy ±2%
± 5 % for amplitude of 2 Hz square wave only, fixed at 1 mV lead II
configuration
Waveforms Rates
ECG complex 30 BPM, 60 BPM,
120 BPM, 180 BPM, and 240 BPM
Ventricular fibrillation
Square wave (50 % duty cycle) 0.125 Hz and 2 Hz
Sine wave 10 Hz, 40 Hz, 50 Hz, 60 Hz, and
100 Hz
Triangle wave 2 Hz
Pulse (63 ms pulse width) 30 BPM and 60 BPM
Test standards
Available selections ANSI/AAMI ES-1, IEC62353, IEC60601-1, and AS/NZS 3551
Built-in test sequences
IEC60601-1 3rd Edition Patient Monitor, Defibrillator, Infusion Pump, Ultrasound Device, Ge-
neric Device and System
IEC62353 Patient Monitor, Defibrillator, Infusion Pump, Ultrasound Device and
Generic Device
NFPA-99 (Hospital) Patient Monitor, Defibrillator, Infusion Pump, Ultrasound Device and
Generic Device
ANSI/AAMI ES1 Patient Monitor, Defibrillator, Infusion Pump, Ultrasound Device and
Generic Device

Communications
USB device upstream port Mini-B connector for control by a computer
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 ratings
Mains voltage outlet 120 V ac 230 V ac
Mains voltage inlet power 90 V ac rms to 132 V ac rms 180 V ac rms to 264 V ac
range rms
Maximum current 20 A 16 A
Hz 47 to 63 Hz 47 to 63 Hz
Physical case
Dimensions (WxDxH) 17.6 cm x 8.4 cm x 28.5 cm (6.9 in x 3.3 in x 11.2 in)
Weight 1.6 kg (3.5 lb)

4 Fluke Biomedical ESA615 Electrical Safety Analyzer

Environmental
Operating temperature 10 ºC to 40 ºC (50 ºF to 104 ºF)
Storage temperature -20 ºC to 60 ºC (-4 ºF to 140 ºF)
Operating humidity 10 % to 90 % non-condensing
Altitude 100/115 V ac mains supply voltage up to 5000 meters
230 V ac mains supply voltage up to 2000 meters
Warranty Two-year extended warranty (no-cost, available after first-year cali-
bration at any authorized Fluke Biomedical Service Center, otherwise
standard one year warranty applies)

Ordering information

Models/descriptions
4132046 ESA615 US, 115 V
4162180 ESA615 US, 115 V with Ansur automation software
4132054 ESA615-01 France/Belgium, 230V
4162198 ESA615 France/Belgium, 230 V with Ansur automation software
4132093 ESA615-02 Europe, 230 V
4162211 ESA615 Europe, 230 V with Ansur automation software
4132101 ESA615-03 Israel, 230 V
4162227 ESA615 Israel, 230 V with Ansur automation software
4132112 ESA615-05 Australia/China, 230 V
4162230 ESA615 Australia/China, 230 V with Ansur automation software
4132120 ESA615-06 UK, 230 V
4162248 ESA615 UK, 230 V with Ansur automation software
4132135 ESA615-07 Switzerland, 230 V
4162253 ESA615 Switzerland, 230 V with Ansur automation software
4132147 ESA615-08 Thailand, 230 V
4162275 ESA615 Thailand, 230 V with Ansur automation software
4132158 ESA615-09 Japan, 100 V
4162282 ESA615 Japan, 100 V with Ansur automation software
4132164 ESA615-10 North America 220V
4162341 ESA615 North America, 220 V with Ansur automation software
4161125 ESA615-11 Brazil 230V
4162352 ESA615 Brazil with Ansur automation software
4161133 ESA615-12 India 230V
4162365 ESA615 India with Ansur automation software

5 Fluke Biomedical ESA615 Electrical Safety Analyzer

Standard accessories
4105850 Operator’s Manual (multilingual CD-ROM)

4105845 Getting Started Guide, hard copy, multilingual

4034393 Data Transfer Cable

3111008 USA/AUS/ISR Accessory Kit: test lead set, TP1 test probe set, AC285 alliga-
tor clip set (ESA T/L kit, country-specific, see below)
2195732 15 – 20 A Adapter (2719-0154)

4151242 USA/NEMA outlet to NBR14136 socket (Brazil only)

3326842 Null Post Adapter
3359538 5-to-5 Banana Jack to ECG (BJ2ECG) Adapter (ESA612-2016)
2248650 Carrying Case
LINE CORD Country-specific power cord
4165219 Ansur ESA615 Plug-in Software (Ansur automation software versions only)

Accessory kits (country specific)

3111008
USA/AUS/ISR Accessory Kit: test lead set, TP1
test probe set, AC285 alligator clip set (ESA T/L kit, USA)
3111024 EUR Accessory Kit: test lead set, TP74 test probe set, AC285 alligator clip
set (ESA T/L kit, EUR)

Optional accessories
1903307 Retractable test leads (6358)
2392639 Ground pin adapter (US receptacle testing ground lug) (9503-0004)
3392119 1-to-10 ECG adapter box assembly (1210 ECG)
3341333 ZigBee USB dongle
3472633 Ultrasound test cable adapter
2462072 Fix vertical alignment universal snap-to banana adapter
4165219 Ansur ESA615 Plug-In Software
4200364 ESA615, 1 Year Gold CarePlan
4200373 ESA615, 3 Year Gold CarePlan
4200386 ESA615, 1 Year Silver CarePlan
4200399 ESA615, 3 Year Silver CarePlan
4200416 ESA615, 1 Year Bronze CarePlan
4200402 ESA615, 3 Year Bronze CarePlan
About Fluke Biomedical
Fluke Biomedical is the world’s leading manu-
facturer of quality biomedical test and simulation
products. In addition, Fluke Biomedical provides
the latest medical imaging and oncology quality-
assurance solutions for regulatory compliance.
Highly credentialed and equipped with a NVLAP
Lab Code 200566-0 accredited laboratory, Fluke
Biomedical also offers the best in quality and
customer service for all your equipment calibra-
tion needs.

Today, biomedical personnel must meet the

increasing regulatory pressures, higher quality
standards, and rapid technological growth, while
performing their work faster and more efficiently
than ever. Fluke Biomedical provides a diverse
range of software and hardware tools to meet
today’s challenges.

Fluke Biomedical regulatory commitment

As a medical test device manufacturer, we rec-
ognize and follow certain quality standards and
certifications when developing our products. We
are ISO 9001 and ISO 13485 medical device certi-
fied and our products are:
•• CE Certified, where required
•• NIST Traceable and Calibrated
•• UL, CSA, ETL Certified, where required
•• NRC Compliant, where required

Fluke Biomedical.
Trusted for the measurements that matter.

Fluke Biomedical
28775 Aurora Road
Cleveland, OH 44139-1837 U.S.A.
For more information, contact us at:
(800) 850-4608 or Fax (440) 349-2307
Email: [email protected]
Web access: www.flukebiomedical.com
©2012, 2019 Fluke Biomedical. Specifications subject
to change without notice. Printed in U.S.A.
10/2019 4165308c-en

Modification of this document is not permitted

without written permission from Fluke Corporation.