DATREND Systems ES601 Plus Operating Manual

ES601Plus

In te rnatio n al Au to m ate d Ele c tric al Safe ty An alyze r

Operating Manual

ES601Plus

International Automated Electrical Safety Analyzer

Operating Manual

© 2015 Datrend Systems Inc.

Unit 130 - 4020 Viking Way

Richmond, BC • CANADA • V6V 2L4

Tel: [phone] (North America Only) or

604.291.7747 • Fax [phone]

e-mail: [e-mail]

To order this manual, use Part Number 6100-426

Revision

H Corrections for CSA 2010-Apr-28

I Update Address 2012-Aug-30

J Changes per 3.32 Firmware 2014-Jul-31

K Changes per 3.50 Firmware 2015-Oct-14

Revision History

Description Date

Copyright

Datrend Systems Inc. (“DSI”) 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 Datrend Systems Inc.

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 freight 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.

Claims

Our routine method of shipment is via common carrier. 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 your local sales representative or DSI immediately.

Standard Terms and Conditions

Refunds & Credits

Please note only serialized products (products labelled with a distinct serial number) and accessories are eligible for
partial refund and/or credit. Non-serialized parts and accessory items (cables, carrying cases, auxiliary modules,
etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been
damaged, and must be returned complete (meaning all manuals, cables, accessories, etc.) within 90 days of original
purchase and in “as new” and resalable condition. The Return Procedure must be followed.

Return Procedure

Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number,
obtained from Datrend Customer Service. All items being returned must be sent prepaid (freight, duty, brokerage,
and taxes ) to our factory location.

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. Products which
are not in “as new” and resalable condition, are not eligible for credit return and will be returned to the customer at
their expense.

Certification

This instrument was thoroughly tested and inspected and found to meet DSI’s manufacturing specifications when it
was shipped from the factory. Calibration measurements are traceable to the National Research Council of Canada
(NRC) and/or the National Institute of Standards and Technology (NIST). Devices for which there are no NRC/NIST
calibration standards are measured against in-house performance standards using accepted test procedures.

Page i

Warranty

Warranty and Product Support

Datrend Systems Inc. ("DSI") warrants this instrument to be free from defects in materials and workmanship under
normal use and service for one (1) year from the date of original purchase. This warranty will be automatically
extended on a yearly basis, to a maximum of five (5) years from the date of original purchase, provided that
calibration is performed on an annual basis by a Datrend Authorized Service Center. During the warranty period DSI
will, at our option, either repair or replace defects in materials and workmanship at no charge; provided the product
is returned (shipping, duty, brokerage and taxes prepaid) to DSI. Any and all transportation charges incurred are the
responsibility of the purchaser and are not included within this warranty. This warranty extends only to the original
purchaser and does not cover damage from abuse, neglect, accident or misuse or as the result of service or
modification by other than DSI. IN NO EVENT SHALL DATREND SYSTEMS INC. BE LIABLE FOR
CONSEQUENTIAL DAMAGES.

This warranty is subject to the following limitations:

! Touch Screen LCD Display: 1 year limited warranty
! Standard Accessories: 90 day limited warranty
! Damage due to activation of devices under test which are connected to the “applied parts” inputs is not covered

under the warranty

! Re-calibration of the instrument, which has a recommended annual calibration frequency, is not covered under the

warranty.

No warranty shall apply when damage is caused by any of the following:

! Power failure, surges, or spikes,
! Damage in transit or when moving the instrument,
! Improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or misuse of the instrument,
! Fire, water damage, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.

Only serialized products (those items bearing a distinct serial number tag) and their accessory items are covered
under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE WARRANTY. Items such as cables and non-serialized modules are not covered under this warranty.

This warranty gives you specific legal rights and you may have other rights, which vary from province to province,
state to state, or country to country. This warranty is limited to repairing the instrument to DSI's specifications.

When you return an instrument to DSI for service, repair or calibration, we recommend shipment using the original
shipping foam and container. If the original packing materials 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 non-abrasive material around all projecting

parts.

! Use at least four inches of tightly packed, industrial-approved, shock-absorbent material all around the instrument.

DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper
packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and
taxes). No returns will be accepted without a Return Materials Authorization ("RMA”) number. Please contact
Datrend (refer to Chapter 9 of this manual) to obtain an RMA number and receive help with shipping/customs
documentation.

Page ii

Warranty Disclaimer

Should you elect to have your instrument serviced and/or calibrated by someone other than Datrend Systems,
please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality
Seal is removed or broken without proper factory authorization. We strongly recommend, therefore, that you send
your instrument to Datrend Systems for service and calibration, especially during the original warranty period.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as this seal is the key to your
original instrument warranty. In the event that the seal must be broken to gain internal access to the instrument (e.g.,
in the case of a customer-installed firmware upgrade), you must first contact Datrend Systems at 1-800-667-6557.
You will be required to provide us with the serial number for your instrument as well as a valid reason for breaking
the Quality Seal. You should break this seal only after you have received factory authorization. Do not break the
Quality Seal before you have contacted us! Following these steps will help ensure that you will retain the original
warranty on your instrument without interruption.

WARNING

Unauthorized user modifications or application beyond the published specifications may result in electrical shock
hazards or improper operation. Datrend Systems will not be responsible for any injuries sustained due to
unauthorized equipment modifications.

DSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.
UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID
THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES.

®

Fluke is a registered trademark of Fluke Corporation

Microsoft, and Windows are registered trademarks of Microsoft Corp.

Page iii

Page iv

ES601Plus OPERATING MANUAL

Table of Contents

ABBREVIATIONS AND DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . X

SYMBOL DEFINITIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . XII

1 SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.1 Electrical Safety Testing Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.2 Automated Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

1.3 Manual Mode Safety Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Voltage Measurement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Load Current.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Insulation Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Protective Earth Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1.4 Electrical Safety Measurement Terminals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Test Receptacle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Kelvin Cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

AUX1 Terminal (MAP). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

AUX2 Terminal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

To DUT Case Terminal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Applied Parts Terminals. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

1.5 ECG Simulator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Performance Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Arrhythmia Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Defibrillator/AED Test Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Output Amplitude. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Accuracy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.6 User Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Keypad. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Audio Indicator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1.7 Non-Volatile Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Memory Type. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Data Capacity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.8 Printer Port Data Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Hardware Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.9 RS-232 Port Data Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Hardware Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Serial Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

1.10 USB Data Transfer/Capture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Hardware Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Data Transfer Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

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ES601Plus OPERATING MANUAL

1.11 Ethernet Data Transfer/Capture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Hardware Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Data Transfer Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.12 Keyboard and Barcode Scanner Ports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.13 Electrical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.14 Environment for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.15 Dimensions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.16 Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.17 Standard Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

1.18 Optional Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.19 Installed Software Modules.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.20 Optional Software Modules.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.21 Compliance With Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2 OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.1 Testing Electrical Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.1.1 Insulation Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.1.2 Protective Earth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2.1.3 Line Voltage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.1.4 Load Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.1.5 Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2.1.6 Touch Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.1.7 Earth Leakage Current.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

2.1.8 Patient Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

2.1.9 Patient Auxiliary Leakage Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

2.1.10 Alternative and Direct Methods of Leakage Current Measurement. . . . . 15

2.1.11 Battery-Power Protocols.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

2.1.12 Safety AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

2.2 Characteristics of ES601Plus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.2.1 Test Receptacle Configuration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.2.2 Standard Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Installed Software Modules. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.2.3 Optional Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

2.3 Interface Layout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3 SETUP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.1 Powering Up/Start-up Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

3.2 System Settings Menu #1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

3.3 System Settings Menu #2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

3.4 System Settings Menu #3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

3.5 About the QWERTY Keypad.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

3.6 Safety AutoSequence Editor.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

4 CONNECTING TO ES601PLUS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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ES601Plus OPERATING MANUAL

4.1 Connecting an AC-Powered DUT to ES601Plus. . . . . . . . . . . . . . . . . . . . . . . . . 39

4.2 Connecting a Battery-Powered DUT to ES601Plus.. . . . . . . . . . . . . . . . . . . . . . 41

4.3 Connecting Peripheral Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5 MANUAL TESTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.1 Manual Mode Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.2 Clip Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.3 Safety Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.4 Safety Limits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.5 Device Information Editor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.6 Line Voltage Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5.7 Load Current Test.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

5.8 Insulation Resistance Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.9 Protective Earth Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

5.10 Leakage Current Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

5.11 Viewing the Clip Record. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

5.12 Saving a Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

5.13 Reviewing Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

5.14 Viewing Test Data and Report Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

5.14.1 Viewing a Record.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

5.14.2 Report Output. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90

5.14.3 Using HyperTerminal to Capture Test Results. . . . . . . . . . . . . . . . . . . . . . . . 92

5.15 ECG Simulator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94

5.16 Technician Timer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

6 AUTOMATED TESTING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

6.1 Automated Testing with ES601Plus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

6.1.1 Safety AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

6.1.2 ECG AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

6.1.3 Other AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

6.1.4 Test Procedures.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

6.2 Automated Testing Principles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

6.2.1 ES601Plus Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

6.2.2 General Inspections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116

6.2.3 Tester AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

6.2.4 Test Procedures.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

6.2.5 Instruction Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

6.2.5.1 The P Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

6.2.5.2 The K Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

6.2.5.3 The I Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

6.2.5.4 The E Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

6.2.5.5 The C Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

6.2.5.6 The R Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

6.2.5.7 The M Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

6.2.5.8 The D Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

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ES601Plus OPERATING MANUAL

6.2.5.9 The A Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

6.2.5.10 Instruction Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129

6.3 Equipment Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

6.3.1 Device ID Search. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

7 COMPUTER CONTROL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

7.1 Overview of Computer Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

7.2 Connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

7.3 Communication Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

7.4 Protocol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

7.4.1 General Format of Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

7.4.2 Safety Test Execution. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

7.4.3 Test Report Download. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

7.4.4 Format of Measurement Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

8 ES601PC SOFTWARE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

8.1 Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

8.2 Installing USB Drivers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

8.3 Running ES601pc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

8.4 Backup and Restore. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

8.5 Safety AutoSequence Editor (standard accessory).. . . . . . . . . . . . . . . . . . . . . 145

8.5.1 Editing the AutoSequence Title. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

8.5.2 Choosing the Standard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

8.5.3 Limits (All Standards). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

8.5.4 Equipment Class. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

8.5.5 Line Voltage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

8.5.6 Insulation Resistance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

8.5.7 Load Current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

8.5.8 Protective Earth. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

8.5.9 Leakage Current (IEC60601 and AAMI-ES1). . . . . . . . . . . . . . . . . . . . . . 148

8.5.10 Leakage Current (VDE0751 and IEC62353). . . . . . . . . . . . . . . . . . . . . 148

8.5.11 Leakage Current (Battery-powered devices). . . . . . . . . . . . . . . . . . . . . 148

8.5.12 Leakage Current (IEC61010). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

8.5.13 Device Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

8.5.14 Polarity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

8.5.15 Line 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

8.5.16 Ground. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

8.5.17 Patient-Applied Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

8.5.18 Applied Part Groups.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

8.5.19 Auxiliary (Interlead) Leakages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

8.5.20 Isolated Signals Inputs/Outputs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151

8.5.21 Exposed Ungrounded Metal Parts (IEC60601).. . . . . . . . . . . . . . . . . . . 151

8.5.22 Protocol (VDE0751 and IEC62353). . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

8.5.23 Test Point-to-Point (IEC61010). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

8.5.24 Uploading AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

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ES601Plus OPERATING MANUAL

8.5.25 Downloading AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

8.5.26 Printing AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153

8.6 ECG AutoSequence Editor (standard accessory). . . . . . . . . . . . . . . . . . . . . . . 153

8.6.1 Editing the AutoSequence Title. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

8.6.2 Adding a Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

8.6.3 Removing a Waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

8.6.4 Modifying the Order of Waveforms in a Sequence.. . . . . . . . . . . . . . . . . 155

8.6.5 Deleting a Sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

8.6.6 Uploading AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155

8.6.7 Downloading AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

8.6.8 Printing AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

8.7 Test Report Generator (standard accessory). . . . . . . . . . . . . . . . . . . . . . . . . . 156

8.7.1 Downloading Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156

8.7.2 Searching For Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

8.7.3 Opening Existing Test Reports.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

8.7.4 Viewing Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

8.7.5 Printing Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

8.7.6 Saving Test Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

8.8 AutoSequence Editor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162

8.8.1 Editing an Inspection or User Tester Sequence. . . . . . . . . . . . . . . . . . . . 162

8.8.2 Editing an AutoSequence.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163

8.8.3 Editing an Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164

Selecting the Op Code. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Selecting the Category. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165

Entering the Command/Prompt. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

8.8.4 Creating a New Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

8.8.5 Filtering the Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

8.8.6 Deleting an Instruction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

8.8.7 Importing Instructions.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168

8.8.8 Clearing an Inspection Procedure or User Tester Sequence. . . . . . . . . . 168

8.8.9 Uploading AutoSequences.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

8.8.10 Downloading AutoSequences. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169

8.9 Test Procedure Editor.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

9 CALIBRATION AND MAINTENANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175

APPENDIX A. SAFETY & ECG AUTOSEQUENCES. . . . . . . . . . . . . . . . . . . . . . . . 177

APPENDIX B. SAMPLE TEST RECORD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199

APPENDIX C. AUTOMATED TEST EXAMPLES.. . . . . . . . . . . . . . . . . . . . . . . . . . . 205

APPENDIX D. IMPORTING EQUIPMENT RECORDS. . . . . . . . . . . . . . . . . . . . . . . . 209

Table of Contents # Page ix

ES601Plus OPERATING MANUAL

Abbreviations and Definitions

The following abbreviations, terms and acronyms are used throughout this manual:

uA

A

AAMI

AP

AutoSequence

Cct.

Clip Record

DUT

Earth

Equipment Record

Flash Memory

GND or Ground

Micro-ampere

Ampere

American Association of Medical Instrumentation

Applied Parts

A series of measurements or test operations that are run automatically in
a predefined order, with or without user involvement.

Abbreviation for circuit (ie. electrical circuit in a power distribution system)

Temporary (volatile) memory where device information and test data is
accumulated, until the data is saved as a Test Record.

Device Under Test. The electrical device being tested.

See GND

Contains the control number of a device and a reference to an associated
PM procedure (Test Procedure) for that device.

Non-volatile memory used for storing Test Records and other
configuration-related data such as user settings, AutoSequences, Test
Procedures and Equipment Records. The contents of the flash memory
are retained when the power to ES601Plus is switched off.

The line (conductor) connected to a place that is maintained at “Ground”
or “Earth” voltage. Same as Protective Earth.

Hz

IEC

kHz

L1 or Line 1

L2 or Line 2

LA

LL

MAINS

M.A.P. / MAP

Hertz

International Electrotechnical Commission

kilohertz

Line 1 of the AC supply voltage, or "mains". In North America, the “Hot” or
“Live” line (conductor) of the AC supply.

Line 2 of the AC supply voltage, or "mains". In North America, the
“Neutral” line (conductor) of the AC supply.

left arm ECG lead

left leg ECG lead

The voltage provided by the building installation, nominally 120 VAC or
230 VAC depending on the country

Mains on applied part(s)

Definitions # Page x

ES601Plus OPERATING MANUAL

Measurement Category I
Terminal

Measurement Category II
Terminal

MHz

PE

QWERTY Keypad

RA

RL

RMS

Safety Standard

Test Procedure

Intended for measurements on circuits with no direct connection to
MAINS (CAT I)

Intended for measurements on circuits which may have a direct
connection to MAINS (CAT II)

Megahertz

Protective Earth. The line (conductor) connected to a place that is
maintained at “Ground” or “Earth” voltage.

The user interface device for entering text or numeric figures. The layout
of the keypad is that of a standard North American PC Keyboard.

right arm ECG lead

right leg ECG lead

Root-Mean-Square measurement of amplitude.

Standards established by various national and international regulatory
agencies. The most recognized Standards Organizations include:
AAMI - Association for Advancement of Medical Instrumentation
IEC - International Electrotechnical Commission
VDE - Verband der Elektrotechnik, Elektronik und Informationstechnik

A type of AutoSequence that can be linked to the control number of a
device through an Equipment Record.

Test Record

Type B (Body)

Type BF (Body Floating)

Type CF (Cardiac Floating)

V

V1-V6

Vrms

Safety, ECG and other test result data which have been saved to the
non-volatile flash memory as a record of all tests performed on a
particular device, as identified by I.D. or control number. A Test Record
may be recalled from the flash memory for viewing on the LCD or
printing. Test Records can be downloaded in bulk to a PC using ES601pc
software.

Non-patient equipment, or equipment with grounded patient connection.

Equipment with a floating patient connection

Equipment with a floating connection intended for direct cardiac
application

Volt

Precordial ECG leads

Volts rms

Definitions # Page xi

ES601Plus OPERATING MANUAL

Symbol Definitions

The following symbols may be found on ES601:

CONSULT MANUAL FOR PROPER OPERATION

The operating manual provides valuable information on the proper use of ES601Plus. It is highly recommended
the operator read the instructions thoroughly before operating the device. It is possible to damage the Device

Under Test (DUT) and/or cause harm to the operator if ES601Plus is used incorrectly.

AUX1: LINE VOLTAGE TO FLOATING I/O ~264V max

During testing of the isolation of (floating) input/output connections on the DUT, an AC voltage of 110% of the
line voltage is applied to the AUX1 (CAT I) connector (Yellow 4mm banana jack), which is connected to the
(floating) input/output connector(s). This AC voltage may reach a maximum of ~264 VAC and, while current
limited, represents a serious shock hazard to the operator. Proper precautions should be taken when performing
a test which includes the application of this voltage to the (floating) input/output connector(s). When a hazardous
voltage is present at the AUX1 connector, a red LED adjacent to the AUX1 connector will be ON .

APPLIED PARTS: Hazardous Voltage: 264 VAC or 500 VDC max

This warning appears on the Applied Parts label on the front of ES601Plus. During testing of the isolation of the
DUT Applied Parts with respect to either ground, or to the power input leads, a voltage of either 110% of the AC

line voltage or 500 VDC may be present on the Applied Parts (CAT I) connectors. This voltage may reach a
maximum of ~264 VAC or 500 VDC and, while current limited, represents a serious shock hazard to the operator.
Proper precautions should be taken when performing a test which includes the application of this voltage to the
Applied Parts connectors. When a hazardous voltage is present at the Applied Parts connectors, a red LED
adjacent to the warning on the Applied Parts label will be ON .

CAUTION: Electrical Shock Hazard, Refer Servicing to Qualified Personnel
CAUTION: Consult Accompanying Documents

These warnings appear on the serial number label of ES601Plus. ES601Plus contains hazardous electrical
voltages internally which WILL BE present when the covers are removed. The operator should read the Operating

Manual to determine what actions to take in the event of failure of ES601Plus. Refer to the Troubleshooting and
Maintenance Section of the Operating Manual.

Definitions # Page xii

ES601Plus OPERATING MANUAL

Kelvin Cable

The Kelvin Cable (CAT I) is used to measure the Protective Earth Resistance, using either a 1A DC current or
a 25A AC current (optional). The voltage present at these terminals is low, but the 25A AC current can present
a potential hazard if used incorrectly. Consult the Operating Manual for the proper operation of the Protective
Earth Resistance test.

DO NOT EXCEED THE FOLLOWING CURRENT LOAD ON THE D.U.T .
RECEPTACLE:

15AMPS @ 100 - 120 VAC, 60 Hz (in 20A circuit)
11AMPS @ 100 - 120 VAC, 60 Hz (in 15A circuit)
12AMPS @ 230 VAC, 50 Hz (in 16A circuit)

The regulatory requirements for loading a circuit (cct.) in a power distribution system sets a current limit on any
individual receptacle to 80% of the value of the circuit breaker on that circuit. For instance, in a circuit with a 15A
circuit breaker (or fuse), the maximum current allowed to be drawn from any individual receptacle is 12A.
Allowing 1A for the ES601Plus circuitry, the load current for the Device Under Test (D.U.T.) should not exceed

11A. These limits are set by the Electrical Code in most jurisdictions in an attempt to avoid unexpected circuit
overloads and subsequent circuit failure. If the D.U.T. load is expected to approach the maximum value on a
routine basis, it is recommended that a circuit with only a single receptacle be provided for use with ES601Plus.

WARNING: OPENING THE ES601Plus MAY COMPROMISE USER SAFETY.
REFER SERVICING TO DATREND AUTHORIZED AGENT.

ES601Plus is a complex instrument which contains internally distributed line voltages and other high voltages for
specific measurement purposes. Failure to observe appropriate measures when the instrument has been

opened, or failure to reassemble correctly may compromise the safety of the user.

WARNING: GROUNDING CIRCUIT CONTINUITY IS VITAL FOR SAFE
OPERATION. NEVER OPERATE THE ES601Plus WITH GROUNDING

CONDUCTOR DISCONNECTED.

Proper grounding is essential to ensure operator safety. Do not bypass the grounding provisions inherent in the
design of ES601Plus, otherwise, the operator may be subjected to an electrical shock risk.

Definitions # Page xiii

ES601Plus OPERATING MANUAL

WARNING: HAZARDOUS VOLTAGES OR CONDITIONS MAY EXIST DURING
TESTS. CONSULT THE ACCOMPANYING DOCUMENTS FOR APPROPRIATE
PRECAUTIONS.

During the execution of an electrical safety test on the D.U.T., ES601Plus may apply high voltages (up to 264 VAC
or 500 VDC) to the D.U.T. While these voltages are current limited, they do represent a shock hazard to the

operator if precautions are not followed. Consult the instructions in this manual regarding Mains on Applied Part
leakage current tests and Insulation Resistance tests for further information.

Definitions # Page xiv

ES601Plus OPERATING MANUAL

Definitions # Page xv

ES601Plus OPERATING MANUAL

1 Specifications

Equipment Performance Specifications

1.1 Electrical Safety Testing Standards

- IEC60601-1:2005, Third Edition

- IEC60601-2-4:2002, Second Edition

- ANSI/AAMI-ES1:1996

- DIN VDE 0751-1:2001

- IEC62353:2007, FDIS Edition 1

- IEC61010-1:2001, Second Edition

- IEC601-BAT (IEC60601 for battery-powered medical device)

- AAMI-BAT (AAMI-ES1 for battery-powered medical device)

- VDE-BAT (VDE-0751 for battery-powered medical device)

- IEC353-BAT (IEC62353 for battery-powered medical device)

1.2 Automated Testing

- By Safety AutoSequence

- By ECG AutoSequence

- By General Inspection

- By Tester AutoSequence

- By Test Procedure

- By Device ID (Control Number) Search

1.3 Manual Mode Safety Tests

- Line Voltage

- Load Current

- Insulation Resistance

- Protective Earth

- Leakage Current

Specifications/Chapter 1 # Page 1

ES601Plus OPERATING MANUAL

Voltage Measurement

- Range: 0.0 to 300.0 VAC

- Accuracy: DC to 100Hz, V$ 90 VAC, ±1% of reading ±1LSD

DC to 100Hz, V< 90 VAC, ± 2.5 VAC

Load Current

- Range: 0 - 20.00 A AC

- Accuracy: ±2% of reading ±1LSD

Insulation Resistance

- Range: 0.5 to 999.9 megohms

- Accuracy: R # 100 megohm, ±2% of reading ±1LSD

Protective Earth Resistance

- Range: 0.001 to 0.200 ohms at 25A AC

0.001 to 3.000 ohms at ±1A DC bipolar

- Accuracy: ±1% of reading ±1LSD

Leakage Current

- Standards: IEC60601-1, AAMI-ES1:1996, VDE-0751,
IEC62353, IEC61010

- Range: 0 to 14000 uA RMS
0 to 25000 uA DC

- Method: True RMS reading

- Accuracy: DC & 25Hz-200kHz - ±1% of reading ±2LSD
200kHz-1MHz - ±4% of reading ±3LSD

Mains on Applied Parts voltage is 110% of AC supply for IEC60601 tests, or 100% of AC
supply for other safety standards.

1.4 Electrical Safety Measurement Terminals

Test Receptacle:

- CAT II

- Max Voltage: 132 VAC (North America)/ 264 VAC (Europe)

- Max Current: 15A AC (North America)/ 13A AC (Europe)

Kelvin Cable:

- CAT I

- Max Voltage: 8 VAC out, Black Terminal (Source)

- Max Current: 40A AC out, Black Terminal (Source)

- Max Voltage: 8 VAC in, Red Terminal (Sense)

- Max Current: 1mA AC in, Red Terminal (Sense)

Specifications/Chapter 1 # Page 2

ES601Plus OPERATING MANUAL

AUX1 Terminal (MAP):

- CAT I

- Max Voltage: 264 VAC out

- Max Current: 2mA AC out

AUX2 Terminal:

- CAT I

- Max Voltage: PE potential

- Max Current: 6.5mA AC, 20mA DC

To DUT Case Terminal:

- CAT I

- Max Voltage: PE Potential

- Max Current: 40 A AC

Applied Parts Terminals:

- CAT I

- Max Voltage: 264 VAC (MAP Test ), 500 VDC (Insulation Test)

- Max Current: 14mA AC @264 VAC, 50mA DC @ 500 VDC

Connect measurement terminals ONLY as instructed in this manual, see
Chapter 4, Connecting to ES601

1.5 ECG Simulator

Performance Waveforms

- DC Pulse: 4 seconds

- Square Wave: 2 Hz

- Triangle Wave: 2 Hz

- Havertriangle Pulse: 10, 25, 40, 100 and 200 msec, @ 60 BPM

- Sine Wave: 0.5, 10, 20, 40, 50, 60, 70 and 100 Hz

- Normal Sinus Rhythm: 30, 60, 90, 120, 150, 180, 240 and 300 BPM

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ES601Plus OPERATING MANUAL

Arrhythmia Waveforms

- Second Degree A-V Block (BLK II)

- Premature Atrial Contraction (PAC)

- Right Bundle Branch Block (RBBB)

- Premature Ventricular Contraction (PVC)

- R-on-T PVC

- Run of 5 PVC

- Multifocal PVC

- Bigeminy

Defibrillator/AED Test Waveforms

- Atrial Fibrillation (AFIB)

- Asystole

- Supraventricular Tachycardia (SVT)

- Polymorphic VTach @ 140 BPM (PVT140)

- Monomorphic VTach @ 160 BPM (PVT160)

- Ventricular Fibrillation (VFIB)

- Missed beat @ 80, 120 BPM

Output Amplitude

- Selectable: 1mV, 2mV, or 0.5 mV on Lead ll

Accuracy

- Rate: ±0.2%

- Amplitude: ±2%

1.6 User Interface

Display

- Graphic LCD 4.53" x 3.40" (11.5 cm x 86 cm)

- Monochrome backlit

- 320 x 240 pixel graphics

- 53 character x 30 lines text

Keypad

- Touch screen

Audio Indicator

- Single-frequency piezoelectric

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ES601Plus OPERATING MANUAL

1.7 Non-Volatile Memory

Memory Type

1 Megabyte flash memory

Data Capacity

- 170 Test Records (test data)

- 3072 PM Test Data Items

- 18432 Equipment Records

- 500 PM Test Procedures

- 24 Safety Test Autosequences

- 6 ECG Test Autosequences

- 18 General Inspections

- 12 Pulse Oximeter Tester AutoSequences

- 12 IV Pump Tester AutoSequences

- 24 Defibrillator Tester AutoSequences

- 60 AutoSequences for user-defined Testers

AutoSequences, Inspections and PM test procedures are user-programmable via the
ES601pc software package (included on CDROM).

1.8 Printer Port Data Output

Hardware Interface

DB25F, Centronix standard

1.9 RS-232 Port Data Output

Hardware Interface

DB9F

Serial Protocol

9600 baud, N, 8, 1

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ES601Plus OPERATING MANUAL

1.10 USB Data Transfer/Capture

Hardware Interface

USB Device

Protocol

USB 2.0 compliant

Data Transfer Rate

1 Mbit/sec

1.11 Ethernet Data Transfer/Capture

Hardware Interface

RJ-45

Protocol

TCP/IP

Data Transfer Rate

10baseT - 10 Mbits/sec, maximum

1.12 Keyboard and Barcode Scanner Ports

- RS-232 barcode scanner

- PS/2 keyboard or PS/2 barcode scanner

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ES601Plus OPERATING MANUAL

Equipment Technical Specifications

1.13 Electrical Specifications

- Country Specific: 120 VAC(+/- 10%), 60 Hz, 16A in 20A circuit
120 VAC(+/- 10%), 60 Hz, 12A in 15A circuit
230 VAC(+/- 10%), 50 Hz, 13A

Notes:

- This instrument has been designed to test equipment that meets local power distribution
standards, which limit devices to draw no more than 80% of the specified current capacity
of a circuit. For instance, a single device should draw no more than 16A from a single
receptacle on a 20A circuit.

- Externally Accessible Fuses: 1A/250V AGC

- Transient overvoltages typically present on the mains supply are expected to be impulse
withstand (overvoltage) category II of IEC 60364-4-443.

1.14 Environment for Use

- 15 to 40 EC

- 10% to 90% RH

- Altitude: 2000m max.

- Indoor use only

- Pollution Degree 2

1.15 Dimensions

- 9" (23 cm) W x 9" (23 cm) D x 10" (25 cm) H

1.16 Weight

- 12 lbs (5.4 kg) Standard

- 17 lbs (7.7 kg) with PETM option

1.17 Standard Accessories

- Kelvin Cable (P/N 3140-425)

- USB Cable (P/N 3140-403)

- ES601pc Software on CDROM (P/N 6950-003)

- Operating Manual on CDROM

- Power Cord (country specific)

- North America 15A (P/N 3000-009)

- Continental Europe (P/N 3000-011)

- United Kingdom (P/N 3000-012)

- Australia (P/N 3000-018)

- Accessory Bag (P/N 7006-052)

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ES601Plus OPERATING MANUAL

1.18 Optional Accessories

For a complete list of available accessories, visit www.datrend.com or contact Datrend Customer
Service (see Chapter 9 for contact details)

1.19 Installed Software Modules

- Safety Limits Editor

- Safety AutoSequence Editor

- Autosequence Editor

- Test Procedure Editor

- ECG AutoSequence Editor

- Test Report Generator

- Equipment Record Plug-in

- CMMS Data Converters

1.20 Optional Software Modules

Languages: English, French, German, Italian

Note: Language Options can only be installed at the Factory or by an Authorized Service Center only.
Contact Datrend Customer Service for complete details. Refer to Chapter 9 for contact information.

1.21 Compliance With Standards

ES601Plus has been certified to meet the following safety standards:

CAN/CSA-C22.2 No. 61010-1-(2 Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use, Part 1: General Requirements

UL Std. No. 61010-1 (2 Edition) - Safety Requirements for Electrical Equipment for Measurement,

nd

Control, and Laboratory Use - Part 1: General Requirements

nd

IEC/EN 61010-1 (Ed.2.0) - Safety requirements for electrical equipment for measurement, control, and
laboratory use - Part 1: General requirement

Following manufacture, all units are subjected to, and have passed the requirements of the ‘Routine Tests’
defined in Annex F of the above Standard(s).

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ES601Plus OPERATING MANUAL

2 Overview

ES601Plus is designed to be the hub of a total Equipment Management System. The large, graphical touch
screen display provides excellent visibility along with a full QWERTY keyboard and numeric keypad for
data and text input.

ES601Plus provides an interface to PC based equipment management systems and can maintain up to
18,432 Equipment Records in memory for fast access to test protocols. Each Equipment Record contains a
reference to a PM Test Procedure, for quick and easy test selection. 24 editable safety test sequences, 6
editable ECG test sequences and 11 other autosequence modules are available for interfacing ES601Plus to
other test devices such as defibrillator testers, infusion pump analyzers and pulse oximeter testers. These
automated test sequences can be combined, following specific guidelines, into a PM Test Procedure. There
are up to 500 editable PM Test Procedures that can be linked to a control number or run independently.

In addition to the industry standard input/output connections, RS-232 and Centronix, ES601Plus has
added both USB and Ethernet connectivity for ease of control and rapid data transfer to both stand alone
and networked PC systems. ES601Plus also provides connections for RS-232 barcode scanners and PS/2
keyboards or PS/2 barcode scanners.

ES601Plus is a truly INTERNATIONAL, truly AUTOMATED Electrical Safety Analyzer designed to verify the
electrical safety of medical devices, and provides the most complete implementation of international
electrical safety standards testing available, with implementation of signal I/O isolation tests and specific
tests for battery-powered devices.

Automated Safety Tests (Safety Autosequences) are configured to test only those parameters applicable to
the safety standard in use.

ES601Plus can operate in MANUAL mode, allowing individual measurements of a safety test to be
manually selected; or in AUTO mode, running Safety Autosequences.

ES601Plus also provides ECG waveform simulations that, like safety tests, can run manually or by using
ECG autosequences.

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ES601Plus OPERATING MANUAL

In addition to Safety and ECG tests, ES601Plus provides Tester Autosequences that allow the user to
remotely operate and/or acquire test data from an external testing device (e.g. a multimeter, a defibrillator
analyser, etc.) via any of six RS232 Tester Ports. Test Procedures can integrate an optional safety test with
inspection steps and tester remote control steps, which can then be linked to specific equipment control
numbers. These parameters can be programmed by the user by using the ES601pc software package for
Microsoft Windows 2000/XP.

®

2.1 Testing Electrical Safety

ES601Plus performs a number of measurements related to testing the electrical safety of medical devices.
Electrical safety measurements performed by ES601Plus include:

2.1.1 Insulation Resistance

This is a test of the breakdown strength of electrical insulating materials that provide electrical isolation
between certain electrical conductors and the ground connection at the AC receptacle. At the AC line cord
of the DUT, ES601Plus applies a high voltage (500 VDC) between L1 and L2 shorted together, and the

ground. ES601Plus measures the resulting current and reports the test result as resistance in megohms. In a
variation of this test, ES601Plus applies the high voltage between the applied parts and the line cord ground
pin, and measures the resistance.

2.1.2 Protective Earth

In this test, ES601Plus will source one amp of DC current through the dead short circuit that should exist
from the ground pin on the line cord of the DUT to any exposed metal part on the DUT's enclosure. In
practice, the connection from the ground pin to the enclosure of the DUT has a non-zero resistance in the
range of 0.02 to 0.2 ohms, and this is what ES601Plus measures and reports as the test result.

To comply with requirements of various safety standards, ES601Plus performs this measurement twice: the
first resistance is measured with the DC test current sourced into the DUT enclosure and back through line
cord; a second resistance is then measured with the DC test current flowing through the DUT in the
opposite direction. The test result reported by ES601Plus is the larger of the two measurements.

When an ES601Plus with the factory installed Protective Earth Module (or "PETM") is used, an optional
variation of this measurement can be performed where the test current is 25 amps AC RMS, rather than 1
amp bipolar DC. The optional PETM allows protective earth tests to be performed in full accordance with
the requirements of the IEC60601 and IEC61010 safety standards. When an ES601Plus with PETM
conducts a 25A test, ten measurements are taken over a ten-second period. The highest result is reported
and saved in the Test Record.

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ES601Plus OPERATING MANUAL

By providing multiple measurement and point-to-point test modes, ES601Plus accommodates special test
requirements of permanently-installed equipment, and manufacturer-recommended protocols where
continuity of protective earth must be verified at several locations on the equipment. Multiple resistance
measurements and point-to-point testing can be enabled for manual tests or automated test sequences, and
with 1A or 25A test current for units equipped with PETM option.

No te : T h e Pro te c tiv e Earth T e st Mo du le (“P ET M”) is a FACTO RY in s ta lle d o p tio n an d s h o u ld

b e sp e c ifie d w he n th e un it is o rd e re d.

2.1.3 Line Voltage

In this test, ES601Plus connects an internal voltmeter to the AC supply input and reports the AC RMS
voltages measured between L1 and L2, L1 and PE, and L2 and PE.

2.1.4 Load Current

To perform this measurement, ES601Plus connects an internal ammeter to the DUT and measures the
current it draws from the AC line when the DUT is powered up and running.

2.1.5 Leakage Current

Different safety standards require different types of leakage measurements to be performed. ES601Plus
focuses on medical device testing and implements the four general types of leakage measurement specified
in the IEC60601 and AAMI-ES1 standards. The alternative leakage measurements and the direct leakage
measurements of the VDE0751 and IEC62353 safety standards are also provided. ES601Plus can also
perform a leakage test according to the IEC61010 standard for laboratory instruments.

In all, ES601Plus incorporates measurements encompassing the requirements of nine different electrical
safety standards used worldwide.

In accordance with the IEC60601 and AAMI-ES1 safety standards, the types of leakage measurement
performed by ES601Plus are:

Overview/Chapter 2 # Page 11