DATREND Systems ES601-US Operating Manual
ES601-US
Automated Electrical Safety Analyzer
Operating Manual
ES601-US
Automated Electrical Safety Analyzer
Operating Manual
© 2012 - 2014 Datrend Systems Inc.
Unit 130 - 4020 Viking Way
Richmond, BC • CANADA • V6V 2L4
Tel 604.291.7747 or 800.667.6557 • Fax 604.294.2355
e-mail customerservice@datrend.com
To order this manual, use Part Number 6100-432
Revision
B Improve Text 2012-Aug-30
C Update Address & Logo 2014-Nov-04
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 Checkitems, 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 Checklists.
Page i
Warranty
Warranty and Product Support
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; punctures, dents and scratches are not covered
!
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
SimCube® is a registered trademark of Pronk Technologies Inc.
Microsoft® and Windows® are registered trademarks of Microsoft Corp.
Page iii
Page iv
ES601-US OPERATING MANUAL
Table of Contents
A
BBREVIATIONS AND DEFINITIONS
S
YMBOL DEFINITIONS
1 S
PECIFICATIONS
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
Ground Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.4 Electrical Safety Measurement Terminals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Test Receptacle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Kelvin Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
AUX1 Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
AUX2 Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
To DUT Case Terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Applied Part (patient lead) 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
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
XI
XIII
Table of Contents # Page v
ES601-US 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 Compliance With Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2 O
VERVIEW
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 Testing Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.1 Insulation Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.2 Ground Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.3 Line Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.4 Load Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.1.5 Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.6 External Case Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.7 Internal Case Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.1.8 Lead Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.1.9 Lead-to-Lead Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.1.10 Alternative and Direct Methods of Leakage Current Measurement . . . . 15
2.1.11 Battery-Power Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.1.12 Safety AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.2 Characteristics of ES601-US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 S
ETUP
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1 Powering Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2 System Settings Menu #1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.3 System Settings Menu #2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.4 System Settings Menu #3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.5 About the QWERTY Keypad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
3.6 Safety AutoSequence Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Table of Contents # Page vi
ES601-US OPERATING MANUAL
4 C
ONNECTING TO
ES601-US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.1 Connecting an AC-Powered DUT to ES601-US . . . . . . . . . . . . . . . . . . . . . . . . 39
4.2 Connecting a Battery-Powered DUT to ES601-US . . . . . . . . . . . . . . . . . . . . . . 41
4.3 Connecting Peripheral Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
5 M
ANUAL TESTING
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.1 Manual Mode Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.2 Data Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.3 Safety Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
5.4 Safety Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.5 Equipment Information Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
5.6 Line Voltage Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
5.7 Load Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
5.8 Insulation Resistance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
5.9 Ground Resistance Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
5.10 Leakage Current Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
5.11 Viewing the Data Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.12 Saving a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
5.13 Reviewing Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
5.14 Viewing Test Data and Report Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.14.1 Viewing a Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
5.14.2 Report Output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
5.14.3 Using HyperTerminal to Capture Test Results . . . . . . . . . . . . . . . . . . . . . . . 88
5.15 ECG Simulator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
5.16 Capturing Test Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
6 A
UTOMATED TESTING
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.1 AutoSequence Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
6.1.1 Safety AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
6.1.2 ECG AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
6.1.3 Tester AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
6.1.4 Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
6.1.5 Checkitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
6.1.5.1 The P Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
6.1.5.2 The K Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
6.1.5.3 The I Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
6.1.5.4 The E Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
6.1.5.5 The C Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
6.1.5.6 The R Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
6.1.5.7 The M Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
6.1.5.8 The D Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
6.1.5.9 The A Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
6.1.5.10 Checkitem Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
6.1.6 Physical Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Table of Contents # Page vii
ES601-US OPERATING MANUAL
6.2 Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
6.2.1 Control Number Search . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
6.2.2 Test Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
6.2.3 Equipment Records by Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
7 C
OMPUTER 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-US S
OFTWARE
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
8.1 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
8.2 Installing USB Drivers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
8.3 Running ES601pc-US . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
8.4 Backup and Restore . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
8.5 Test Report Generator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
8.5.1 Downloading Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
8.5.2 "Pass" Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
8.5.3 "New" Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
8.5.4 Searching For Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
8.5.5 Opening Existing Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147
8.5.6 Viewing Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
8.5.7 Printing Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8.5.8 Saving Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8.5.8.1 Saving as TXT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8.5.8.2 Saving as CSV . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149
8.6 Safety AutoSequence Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
8.6.1 Editing the AutoSequence Title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
8.6.2 Choosing the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.6.3 Limits (All Standards) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.6.4 Equipment Class . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.6.5 Line Voltage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.6.6 Insulation Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151
8.6.7 Load Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
8.6.8 Ground Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
8.6.9 Leakage Current (IEC60601 and AAMI-ES1) . . . . . . . . . . . . . . . . . . . . . 152
8.6.10 Leakage Current (VDE0751 and IEC62353) . . . . . . . . . . . . . . . . . . . . 152
8.6.11 Leakage Current (Battery-powered devices) . . . . . . . . . . . . . . . . . . . . 152
8.6.12 Leakage Current (IEC61010) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
8.6.13 Equipment Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
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ES601-US OPERATING MANUAL
8.6.14 Polarity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
8.6.15 Neutral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
8.6.16 Ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
8.6.17 Patient Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
8.6.18 Patient Lead Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
8.6.19 Lead-to-Lead Leakages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
8.6.20 Isolated Signals Inputs/Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
8.6.21 Exposed Ungrounded Metal Parts (IEC60601) . . . . . . . . . . . . . . . . . . . 155
8.6.22 Protocol (VDE0751 and IEC62353) . . . . . . . . . . . . . . . . . . . . . . . . . . . 155
8.6.23 Test Point-to-Point (IEC61010) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
8.6.24 Uploading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
8.6.25 Downloading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
8.6.26 Printing AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
8.6.27 Return to Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157
8.7 Safety Limits Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
8.7.1 Editing Safety Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158
8.7.2 Uploading Safety Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
8.7.3 Downloading Safety Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
8.8 ECG AutoSequence Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
8.8.1 Editing the AutoSequence Title . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
8.8.2 Adding a Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
8.8.3 Removing a Waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162
8.8.4 Modifying the Order of Waveforms in a Sequence . . . . . . . . . . . . . . . . . 162
8.8.5 Deleting a Sequence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8.8.6 Uploading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8.8.7 Downloading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8.8.8 Printing AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8.8.9 Return to Main Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
8.9 Checklist Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164
8.9.1 Uploading Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
8.9.2 Downloading Checklists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
8.9.3 Editing a Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
8.9.4 Checkitem Database Editor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
8.9.4.1 Selecting the Op Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
8.9.4.2 Selecting the Category . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168
8.9.4.3 Entering the Command/Prompt . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
8.9.4.4 Configuring the "A" Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . 170
8.9.5 Creating a New Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171
8.9.6 Filtering Checkitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
8.9.7 Deleting a Checkitem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172
8.9.8 Importing Checkitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
8.9.9 Printing Checkitems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
8.10 Inspections and User Testers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
8.10.1 Uploading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
8.10.2 Downloading AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Table of Contents # Page ix
ES601-US OPERATING MANUAL
8.10.3 Editing an Inspection or User Tester Sequence . . . . . . . . . . . . . . . . . . 177
8.11 Equipment Record Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
8.11.1 Creating a New Equipment Record . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
8.11.2 Copying Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
8.11.3 Deleting Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
8.11.4 Editing Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181
8.11.5 Searching Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
8.11.6 Importing Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
8.11.7 Uploading Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
8.11.8 Printing Equipment Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
8.11.9 Record Viewing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
8.12 CMMS Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
8.12.1 Exporting CMMS Data to ES601-US . . . . . . . . . . . . . . . . . . . . . . . . . . 187
8.12.2 Importing a MUP File from ES601-US . . . . . . . . . . . . . . . . . . . . . . . . . 190
8.12.3 Modifying Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
8.12.3.1 Download Checkitems Option . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
8.12.3.2 medTester-to-ES601 Translation Table . . . . . . . . . . . . . . . . . . . . 192
9 C
ALIBRATION AND MAINTENANCE
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
APPENDIX A. S
APPENDIX B. S
APPENDIX C. A
APPENDIX D. I
AFETY AUTOSEQUENCES
AMPLE TEST RECORD
UTOMATED TEST EXAMPLES
MPORTING EQUIPMENT RECORDS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
. . . . . . . . . . . . . . . . . . . . . . . . . . . 213
. . . . . . . . . . . . . . . . . . . . . . . 217
Table of Contents # Page x
ES601-US OPERATING MANUAL
Abbreviations and Definitions
The following abbreviations, terms and acronyms are used throughout this manual:
uA
A
AAMI
AutoSequence
Cct.
Checklist
DUT
Earth
Equipment Record
Flash Memory
GND or Ground
Hz
Micro-ampere
Ampere
American Association of Medical Instrumentation
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)
A type of AutoSequence that can be linked to the control number of a
device through an Equipment Record.
Device Under Test. The electrical equipment or device being tested.
Same as "GND" or "ground" (see below).
Contains the control number of a device and a reference to an associated
maintenance procedure (Checklist) for that device.
Non-volatile memory used for storing Test Records and other
configuration-related data such as user settings, AutoSequences,
Checklists and Equipment Records. The contents of the flash memory
are retained when the power to ES601-US is switched off.
The line (conductor) connected to a place that is maintained at “Ground”
or “Earth” potential.
Hertz
IEC
kHz
L1 or Line 1
L2 or Line 2
LA
LL
MAINS
M.A.P. / MAP
Measurement Category I
Terminal
International Electrotechnical Commission
kilohertz
The “Hot” or “Live” line (conductor) of the AC supply.
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). An isolation test of one or more patient leads.
Intended for measurements on circuits with no direct connection to
MAINS (CAT I)
Definitions # Page xi
ES601-US OPERATING MANUAL
Measurement Category II
Terminal
MHz
PE
QWERTY Keypad
RA
RL
RMS
Safety Standard
Test Record
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
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 the equipment 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-US software.
Type B (Body)
Type BF (Body Floating)
Type CF (Cardiac Floating)
V
V1-V6
Vrms
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 xii
ES601-US OPERATING MANUAL
Symbol Definitions
The following symbols may be found on ES601-US:
CONSULT MANUAL FOR PROPER OPERATION
The operating manual provides valuable information on the proper use of ES601-US. It is highly recommended
the operator read the Checkitems thoroughly before operating the device. It is possible to damage the Device
Under Test (DUT) and/or cause harm to the operator if ES601-US 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 (patient leads) label on the front of ES601-US. During testing of the
isolation of the DUT patient leads 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 part (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 part connectors. When a hazardous voltage is present at the 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 ES601-US. ES601-US 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 ES601-US. Refer to the Troubleshooting and
Maintenance Section of the Operating Manual.
Definitions # Page xiii
ES601-US OPERATING MANUAL
Kelvin Cable
The Kelvin Cable (CAT I) is used to measure the Ground Resistance, using a 1A current. Consult the Operating
Manual for the proper operation of the Ground 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 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 ES601-US.
WARNING: OPENING THE ES601 MAY COMPROMISE USER SAFETY.
REFER SERVICING TO DATREND AUTHORIZED AGENT.
ES601-US 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 ES601 WITH GROUNDING CONDUCTOR
DISCONNECTED.
Proper grounding is essential to ensure operator safety. Do not bypass the grounding provisions inherent in the
design of ES601-US, otherwise, the operator may be subjected to an electrical shock risk.
WARNING: HAZARDOUS VOLTAGES OR CONDITIONS MAY EXIST DURING
TESTS. CONSULT THE ACCOMPANYING DOCUMENTS FOR APPROPRIATE
PRECAUTIONS.
Definitions # Page xiv
ES601-US OPERATING MANUAL
During the execution of an electrical safety test on the D.U.T., ES601-US 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 patient lead leakage
current tests and Insulation Resistance tests for further information.
Definitions # Page xv
ES601-US OPERATING MANUAL
Definitions # Page xvi
ES601-US OPERATING MANUAL
1 Specifications
Equipment Performance Specifications
1.1 Electrical Safety Testing Standards
- ANSI/AAMI-ES1:1996
- IEC60601-1:2005, Third Edition
- IEC60601-2-4:2002, Second Edition
- DIN VDE 0751-1:2001
- IEC62353:2007, FDIS Edition 1
- IEC61010-1:2001, Second Edition
- AAMI-BAT (AAMI-ES1 for battery-powered medical device)
- IEC601-BAT (IEC60601 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 Control Number Search
- By PM Checklist
- By Safety AutoSequence
- By ECG AutoSequence
- By Physical Inspection
- By Tester AutoSequence
1.3 Manual Mode Safety Tests
- Line Voltage
- Load Current
- Insulation Resistance
- Ground Resistance
- Leakage Current
Specifications/Chapter 1 # Page 1
ES601-US 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
Ground Resistance
- Range: 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
Lead isolation test 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
ES601-US OPERATING MANUAL
AUX1 Terminal:
- CAT I
- Max Voltage: 264 VAC out
- Max Current: 2mA AC out
AUX2 Terminal:
- CAT I
- Max Voltage: Ground potential
- Max Current: 6.5mA AC, 20mA DC
To DUT Case Terminal:
- CAT I
- Max Voltage: Ground Potential
- Max Current: 40 A AC
Applied Part (patient lead) Terminals:
- CAT I
- Max Voltage: 264 VAC (Isolation 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
Specifications/Chapter 1 # Page 3
ES601-US 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
Specifications/Chapter 1 # Page 4
ES601-US OPERATING MANUAL
1.7 Non-Volatile Memory
Memory Type
1 Megabyte flash memory
Data Capacity
- 170 Test Records (safety and ECG test data)
- 3072 PM Test Data Items (checklist test results)
- 18432 Equipment Records
- 500 PM Checklists
- 24 Safety Test Autosequences
- 6 ECG Test Autosequences
- 18 Physical Inspections
- 12 AutoSequences for Oxitest +7 Pulse Oximeter Tester
- 12 AutoSequences for Infutest 2000 IV Pump Tester
- 24 AutoSequences for Phase 3 Defibrillator/Pacemaker Tester
- 60 AutoSequences for user-defined Testers
AutoSequences, Inspections and PM Checklists are user-programmable via the ES601pc-US
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
Specifications/Chapter 1 # Page 5
ES601-US 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
Specifications/Chapter 1 # Page 6
ES601-US OPERATING MANUAL
Equipment Technical Specifications
1.13 Electrical Specifications
120 VAC(+/- 10%), 60 Hz, 16A in 20A circuit
120 VAC(+/- 10%), 60 Hz, 12A in 15A circuit
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 °C
- 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)
- Power Cord, North America 15A (P/N 3000-009)
- Accessory Bag (P/N 7006-052)
- ES601-US Product CD (P/N 6950-019), including:
- Quick Start Guide
- Operating Manual
- ES601pc-US application software for Microsoft Windows®
Specifications/Chapter 1 # Page 7
ES601-US 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 AutoSequences
- User-Defined Safety Limits
- ECG AutoSequences
- Oxitest +7 AutoSequences
- Infutest 2000 AutoSequences
- Phase 3 AutoSequences
- Physical Inspections
- User-Defined Testers
- Checklists
- Equipment Records
- CMMS Interface
- Test Report Generator
1.20 Compliance With Standards
ES601-US has been certified to meet the following safety standards:
CAN/CSA-C22.2 No. 61010-1-(2nd Edition) - Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use, Part 1: General Requirements
UL Std. No. 61010-1 (2nd Edition) - Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use - Part 1: General Requirements
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).
Specifications/Chapter 1 # Page 8
ES601-US OPERATING MANUAL
2 Overview
ES601-US 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.
ES601-US 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 Checklist, 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 ES601-US 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 Checklist. There are up
to 500 editable PM Checklists that can be linked to a control number or run independently.
In addition to the industry standard input/output connections, RS-232 and Centronix, ES601-US has added
both USB and Ethernet connectivity for ease of control and rapid data transfer to both stand alone and
networked PC systems. ES601-US also provides connections for RS-232 barcode scanners and PS/2
keyboards or PS/2 barcode scanners.
ES601-US is a fully
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.
ES601-US can operate in MANUAL mode, allowing individual measurements of a safety test to be
manually selected; or in AUTO mode, running Safety Autosequences.
ES601-US also provides ECG waveform simulations that, like safety tests, can run manually or by using
ECG autosequences.
In addition to Safety and ECG tests, ES601-US 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
analyzer, etc.) via any of six RS232 Tester Ports. Checklists can integrate an optional safety test with
AUTOMATED
Electrical Safety Analyzer designed to verify the electrical safety of
Overview/Chapter 2 # Page 9
ES601-US OPERATING MANUAL
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-US software package for
Microsoft Windows® 7 or XP.
2.1 Testing Electrical Safety
ES601-US performs a number of measurements related to testing the electrical safety of medical devices.
Electrical safety measurements performed by ES601-US 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, ES601-US applies a high voltage (500 VDC) between hot and neutral shorted together, and the
ground. ES601-US measures the resulting current and reports the test result as resistance in megohms. In a
variation of this test, ES601-US applies the high voltage between the patient leads and the line cord ground
pin, and measures the resistance.
2.1.2 Ground Resistance
In this test, ES601-US 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 ES601-US measures and reports as the test result.
By providing multiple measurement and point-to-point test modes, ES601-US accommodates special test
requirements of permanently-installed equipment, and manufacturer-recommended protocols where
continuity of ground 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.
2.1.3 Line Voltage
In this test, ES601-US connects an internal voltmeter to the AC supply input and reports the AC RMS
voltages measured between hot and neutral, hot and ground, and neutral and ground.
2.1.4 Load Current
To perform this measurement, ES601-US 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.
Overview/Chapter 2 # Page 10
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