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DATREND Systems ES601 Plus Operating Manual

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ES601
Plus
In te rn atio n al Au to m ate d Ele c tric al Safe ty An aly ze r
Operating Manual

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Summary of Contents for DATREND Systems ES601 Plus

  • Page 1 ES601 Plus In te rn atio n al Au to m ate d Ele c tric al Safe ty An aly ze r Operating Manual...
  • Page 3 ES601Plus International Automated Electrical Safety Analyzer Operating Manual © 2015 Datrend Systems Inc. Unit 130 - 4020 Viking Way Richmond, BC • CANADA • V6V 2L4 Tel: 800.667.6557 (North America Only) or 604.291.7747 • Fax 604.294.2355 e-mail: customerservice@datrend.com...
  • Page 5 2015-Oct-14 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.
  • Page 6 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.
  • Page 7 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.
  • Page 8 Page iv...

  • Page 9: Table Of Contents

    ES601Plus OPERATING MANUAL Table of Contents ........BBREVIATIONS AND EFINITIONS .
  • Page 10 ES601Plus OPERATING MANUAL 1.11 Ethernet Data Transfer/Capture........6 Hardware Interface.
  • Page 11 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.
  • Page 12 ES601Plus OPERATING MANUAL 6.2.5.9 The A Instruction........126 6.2.5.10 Instruction Summary.
  • Page 13 ES601Plus OPERATING MANUAL 8.5.25 Downloading AutoSequences....... . 152 8.5.26 Printing AutoSequences........153 8.6 ECG AutoSequence Editor (standard accessory).

  • Page 14: Abbreviations And Definitions

    ES601Plus OPERATING MANUAL Abbreviations and Definitions The following abbreviations, terms and acronyms are used throughout this manual: Micro-ampere Ampere AAMI American Association of Medical Instrumentation Applied Parts A series of measurements or test operations that are run automatically in AutoSequence a predefined order, with or without user involvement.
  • Page 15 ES601Plus OPERATING MANUAL Measurement Category I Intended for measurements on circuits with no direct connection to MAINS (CAT I) Terminal Intended for measurements on circuits which may have a direct Measurement Category II connection to MAINS (CAT II) Terminal Megahertz Protective Earth.

  • Page 16: Symbol Definitions

    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.
  • Page 17 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.
  • Page 18 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.
  • Page 19 ES601Plus OPERATING MANUAL Definitions # Page xv...

  • Page 20: Specifications

    ES601Plus OPERATING MANUAL 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)

  • Page 21: Voltage Measurement

    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...

  • Page 22: Aux1 Terminal (Map)

    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...

  • Page 23: Arrhythmia Waveforms

    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...

  • Page 24: Non-Volatile Memory

    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...

  • Page 25: Usb Data Transfer/Capture

    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 Specifications/Chapter 1 # Page 6...

  • Page 26: Electrical Specifications

    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.

  • Page 27: Optional Accessories

    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 - ECG AutoSequence Editor - Safety AutoSequence Editor - Test Report Generator - Autosequence Editor - Equipment Record Plug-in...

  • Page 28: Overview

    ES601Plus OPERATING MANUAL 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.

  • Page 29: Testing Electrical Safety

    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.

  • Page 30: Line Voltage

    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.

  • Page 31: Touch Current

    ES601Plus OPERATING MANUAL 2.1.6 Touch Current Depending on the safety standard, "touch current" may alternatively be referred to as "enclosure risk current" or "enclosure leakage". In this test, ES601Plus measures the current that flows from a metal part on the DUT enclosure that should be grounded, to the actual protective earth from the AC electrical supply.

  • Page 32: Patient Leakage Current

    ES601Plus OPERATING MANUAL 2.1.8 Patient Leakage Current In this test, ES601Plus measures the current that flows out of the patient applied parts of the DUT though the human body load when the parts are either connected to protective earth (normal condition), or to an isolated AC voltage via a current-limiting resistor (MAP - Mains on Applied Part test).
  • Page 33 ES601Plus OPERATING MANUAL When testing patient leakage, ES601Plus can be configured to record the following AC and DC values for each group of parts defined in the test setup: Normal Polarity Normal Condition (NP:NC) Single-Fault Condition, Line 2 Open (NP:SF L2O) Single-Fault Condition, Earth Open (NP:SF EO) SFC, Mains on Applied Part(s)

  • Page 34: Patient Auxiliary Leakage Current

    ES601Plus OPERATING MANUAL 2.1.9 Patient Auxiliary Leakage Current In this test, sometimes called an interlead leakage test, ES601Plus measures the current that flows out of one applied part, through the human body load, and into all the other applied parts shorted together. As with all leakage tests, auxiliary leakage current is measured in microamps, while simulating a variety of test conditions at the DUT.

  • Page 35: Battery-Power Protocols

    ES601Plus OPERATING MANUAL The advantage of the "Alternative Method" or "Direct Method" of leakage testing under VDE-0751 is either method requires far fewer leakage measurements than either the IEC60601 standard or AAMI-ES1 standard. VDE-0751 allows safety tests to be completed much more rapidly, particularly when executed by ES601Plus.

  • Page 36: Safety Autosequences

    ES601Plus OPERATING MANUAL To accommodate the unique needs of battery-powered devices, ES601Plus incorporates special protocols designated "IEC601-BAT" (IEC60601 standard for self-powered device), "AAMI-BAT" (AAMI-ES1 standard for self-powered device), "VDE-BAT" (VDE-0751 standard for self-powered device) and "IEC353-BAT" (IEC62353 standard for self-powered device). 2.1.12 Safety AutoSequences ES601Plus can be programmed to automatically conduct the safety measurements described above.

  • Page 37: Characteristics Of Es601Plus

    ES601Plus OPERATING MANUAL 2.2 Characteristics of ES601Plus 2.2.1 Test Receptacle Configuration The test receptacle is generally configured to meet these broad configurations, but alternate test receptacles may be substituted based upon the destination. For other configurations, please contact Datrend Customer Service.

  • Page 38: Interface Layout

    ES601Plus OPERATING MANUAL 2.3 Interface Layout REAR PANEL: POWER SWITCH: Two-position (toggle) rocker switch AC POWER INPUT (MAINS SUPPLY) FUSES (2): AGC 1A / 250V SIDE PANEL: RS-232 Remote Tester Interface (6) for connection to external testing devices Centronics Printer Port for connecting standard Centronics Printer RS-232 PORT serial interface for connecting to serial printer or COM Port of PC ETHERNET INTERFACE PORT provides communication with PC using ES601pc USB INTERFACE PORT provides communication with PC using ES601pc...
  • Page 39 ES601Plus OPERATING MANUAL Overview/Chapter 2 # Page 20...

  • Page 40: Setup

    ES601Plus OPERATING MANUAL Setup 3.1 Powering Up/Start-up Menu When the power to ES601Plus is switched on, the Start-up menu is displayed while internal self-tests are conducted. The Start-up menu displays the firmware version and the current time and date. Depending on how the "STARTUP MODE" has been configured under System Settings, the above menu may remain on the LCD indefinitely, or may be automatically replaced by either the MANUAL MODE menu or the AUTO MODE menu after a few seconds.
  • Page 41 ES601Plus OPERATING MANUAL The touch screen buttons (“buttons”) provided on the Startup menu are: MANUAL MODE: Enters a menu for performing manual safety tests. Refer to chapter 5. Enters a menu for performing automated safety tests and other types of AUTO MODE: automated tests.

  • Page 42: System Settings Menu #1

    ES601Plus OPERATING MANUAL 3.2 System Settings Menu #1 The “System Settings” menus are available from the Start-up Screen, Manual Mode menu and Auto Mode menu, by pressing the SYSTEM SETTINGS button. System settings are distributed across three menus (#1, #2 and #3), with the third menu allowing for password protection. Fig u re 2: System Settings Menu #1 The buttons provided on Systems Settings Menu #1 are: STARTUP MODE:...
  • Page 43 ES601Plus OPERATING MANUAL COMPUTER Enters a menu for uploading instrument configuration data (autosequences; test procedures; equipment control number lists) into ES601Plus, as transmitted by INTERFACE: a personal computer (PC) running the ES601pc software program. This menu is also used for downloading test data from ES601Plus, into the ES601pc program.

  • Page 44: System Settings Menu #2

    ES601Plus OPERATING MANUAL 3.3 System Settings Menu #2 Fig u re 3: System Setting Menu #2 System Settings Menu #2 shows default Sequence Controls for MANUAL MODE tests. Buttons on the left of this menu pertain to manual leakage and load current tests, and buttons on the right pertain to manual protective earth tests.
  • Page 45 ES601Plus OPERATING MANUAL The buttons provided on Systems Settings Menu #2 are: PAUSE AFTER After each measurement of a manual leakage test, ES601Plus will pause for MEASUREMENT: the indicated time before proceeding with the next measurement of the sequence. The available settings are "NO" (no pause); 1 second (factory default);...
  • Page 46 ES601Plus OPERATING MANUAL If set to "YES", this control will enable multiple protective earth and/or MULTIPLE general resistance measurements within the scope of a manual protective PE TEST: earth test. Up to ten resistance measurements may be recorded by ES601Plus in multiple PE mode.
  • Page 47 ES601Plus OPERATING MANUAL However, OFFSET is similar to other Sequence Controls in that the OFFSET CALIBRATE OFFSET (continued): will be displayed by ES601Plus at the start of every protective earth test, manual or automated. This permits temporary modification of the OFFSET value to suit a particular test lead that may be in use at the time.

  • Page 48: System Settings Menu #3

    ES601Plus OPERATING MANUAL 3.4 System Settings Menu #3 Fig u re 4 - System Settings Menu #3 The buttons provided on System Settings Menu #3 are: SET CLK: Allows setting the internal real time clock. Select date format for the internal real-time clock, as follows: FORMAT: •...
  • Page 49 ES601Plus OPERATING MANUAL Referring to System Setup Menu #2, this global enable/disable switch for PASSWORD ENABLED: the password may be toggled between "YES" and "NO". Default is "NO". When pressed, this button displays the QWERTY keypad for entering a EDIT PASSWORD: password.

  • Page 50: About The Qwerty Keypad

    ES601Plus OPERATING MANUAL 3.5 About the QWERTY Keypad The QWERTY touch keypad of ES601Plus is used for entering system settings, equipment information, control numbers, comments and test data. An example of the QWERTY keypad is shown in Fig u re 6, for entering the ES601 I.D.

  • Page 51: Safety Autosequence Editor

    ES601Plus OPERATING MANUAL 3.6 Safety AutoSequence Editor ES601Plus can be programmed to automatically perform the measurements which comprise a complete test of electrical safety. In an automated test or "AutoSequence", the measurements are performed in a continuous sequence, one after the other. According to the user's programming, the sequence can be optionally broken at specific steps to allow operation of the DUT or changes in electrical connections.
  • Page 52 ES601Plus OPERATING MANUAL Fig u re 8 - AutoSequence editor, Main Menu. The buttons provided on the main menu of the AutoSequence editor are: Press to modify line #1 or line #2 of the AutoSequence title. The TITLE 1 / TITLE 2: QWERTY keypad will be displayed.
  • Page 53 ES601Plus OPERATING MANUAL Press to enter a menu for configuring the leakage current measurements of LEAKAGE CURRENT: the AutoSequence. The appearance of this menu and the range of settings provided by it will depend on the safety standard chosen. The example menu below is for the IEC60601 standard.
  • Page 54 ES601Plus OPERATING MANUAL Press this button to enable leakage measurement in the NEXT: AutoSequence and proceed to the next menu. If APPLIED PARTS of the leakage current menu is set to "TEST", the next menu will be the applied parts editor (see Section 5.10). If APPLIED PARTS is set to "DO NOT TEST", the NEXT button restores the main menu of the AutoSequence editor.
  • Page 55 ES601Plus OPERATING MANUAL Referring back to the editor main menu (Fig u re 8), pressing this button SEQUENCE activates a submenu for setting the Sequence Controls of the CONTROLS: AutoSequence. Each Safety AutoSequence has its own dedicated set of Sequence Controls. Buttons on the left of the Sequence Controls menu pertain to leakage current measurement as described in Section 3.3.
  • Page 56 ES601Plus OPERATING MANUAL SAVE AUTOSEQ: Referring back to the main menu of the AutoSequence editor (Fig u re 8), pressing this button causes ES601Plus to prompt you to store the AutoSequence in non-volatile memory. Responding "YES" to the displayed prompt will store the AutoSequence settings to the memory location indicated, and will return ES601Plus to System Settings Menu #1.
  • Page 57 ES601Plus OPERATING MANUAL Setup/Chapter 3 # Page 38...

  • Page 58: Connecting To Es601Plus

    ES601Plus OPERATING MANUAL Connecting to ES601Plus When using ES601Plus, the operator is expected to be familiar with the particular Electrical Safety Standard to which the DUT is being tested. It is recommended the operator have access to the Standard and refer to the Standard, as needed, during the test.
  • Page 59 ES601Plus OPERATING MANUAL Fig u re 13 - Connecting to a line-powered DUT Connecting To ES601/Chapter 4 # Page 40...

  • Page 60: Connecting A Battery-Powered Dut To Es601Plus

    ES601Plus OPERATING MANUAL 4.2 Connecting a Battery-Powered DUT to ES601Plus Fig u re 14 - Connecting to a battery-powered DUT Connection instructions for battery-powered DUT: • Whenever connecting or disconnecting a DUT or peripheral devices to ES601Plus, the power switches of all equipment should be OFF. •...

  • Page 61: Connecting Peripheral Devices

    ES601Plus OPERATING MANUAL 4.3 Connecting Peripheral Devices Input connections for data entry during tests are optional. Data can always be entered via the on-screen QWERTY keyboard. Fig u re 15 - Connecting Peripheral Devices Connecting To ES601/Chapter 4 # Page 42...

  • Page 62: Manual Testing

    ES601Plus OPERATING MANUAL Manual Testing 5.1 Manual Mode Display MANUAL MODE is entered from either the STARTUP menu or the AUTO MODE menu of ES601Plus. This menu allows the user to select various types of individual electrical safety measurements such as protective earth (ground resistance) or leakage current.

  • Page 63: Safety Standards

    ES601Plus OPERATING MANUAL As ES601Plus is used to perform safety and other tests, the Clip Record will accumulate the following data: • Device Information (control number, description , make, model, etc) • Safety Test Measurements (voltage, current, and resistance values) •...

  • Page 64: Safety Limits

    ES601Plus OPERATING MANUAL When one of the "-BAT" safety standards is selected on the MANUAL MODE menu, buttons for LINE VOLTAGE; LOAD CURRENT; and PROTECTIVE EARTH are removed from the menu, leaving just the LEAKAGE CURRENT and INSULATION RESISTANCE buttons, and other buttons related to saving or reviewing test data.

  • Page 65: Device Information Editor

    ES601Plus OPERATING MANUAL 5.5 Device Information Editor Press the DEVICE EDIT button on the MANUAL MODE menu to enter information about the DUT in the Clip Record of ES601Plus. The DEVICE INFO menu allows entry of equipment information such as I.D.
  • Page 66 ES601Plus OPERATING MANUAL Device information fields accept up to 17 characters, except for the Technician Code ("TECH CODE"), which can be up to 5 characters. The device information fields are retained in the Clip Record, along with manually acquired safety test measurements. Note the DEVICE INFO menu will be automatically displayed by ES601Plus if the ID Number field is blank and SAVE TEST on the MANUAL MODE menu is pressed.

  • Page 67: Line Voltage Test

    ES601Plus OPERATING MANUAL 5.6 Line Voltage Test Pressing the LINE VOLTAGES button on the MANUAL MODE menu allows you to measure the AC supply voltages L1-L2; L1-GND; and L2-GND. During the measurement, the ESCAPE button may be pressed at any time to abort the measurement and return to the MANUAL MODE menu.

  • Page 68: Load Current Test

    ES601Plus OPERATING MANUAL 5.7 Load Current Test Pressing the LOAD CURRENT button on the MANUAL MODE menu allows you to measure the AC current drawn from the supply by the DUT. The power switch of the DUT should be set to "ON" before selecting this test.
  • Page 69 ES601Plus OPERATING MANUAL Fig u re 20 - Load current result. After the load current is displayed, the following options become available: Returns the display to the MANUAL MODE menu. The result is discarded and not ESCAPE: copied to the Clip Record. Causes the measurement to be repeated.
  • Page 70 ES601Plus OPERATING MANUAL Fig u re 21 - Break if "STOP BEFORE..." system setting is "YES". Note the purpose of the "STOP BEFORE..." break is to allow you to accommodate power-sensitive equipment, such as a personal computer or equivalent DUT, which cannot be arbitrarily disconnected from the AC supply without potentially damaging the DUT.

  • Page 71: Insulation Resistance Test

    ES601Plus OPERATING MANUAL 5.8 Insulation Resistance Test Pressing the INSULATION RESISTANCE button on the MANUAL MODE menu allows you to measure the resistance of the DUT's insulation from L1 and L2 supply inputs to the ground connection; or alternatively from all applied parts shorted together to ground. Note the power switch of the DUT should be set to "ON"...
  • Page 72 ES601Plus OPERATING MANUAL WARNING: If testing insulation resistance of applied parts, HIGH VOLTAGE (500 VDC) will be output from the AP jacks for a few seconds during the test. The high voltage is internally current-limited to 2 milliamperes maximum. Unterminated leads attached to the AP jacks therefore present a minor, non-lethal shock hazard to the careless user.
  • Page 73 ES601Plus OPERATING MANUAL Returns the display to the MANUAL MODE menu. The result is discarded and not ESCAPE: saved to the Clip Record. Causes the measurement to be repeated. REPEAT: CONTINUE: Moves the measurement data and Pass/Fail limit (if shown) to the Clip Record. If there is a previous result from this test in the Clip Record, it is overwritten.

  • Page 74: Protective Earth Test

    ES601Plus OPERATING MANUAL 5.9 Protective Earth Test Pressing the PROTECTIVE EARTH button on the MANUAL MODE menu allows you to measure the resistance of the DUT's ground circuit, using a test current of 1-amp DC bipolar or, if using ES601Plus with accessory PETM, 25 amps AC RMS.
  • Page 75 ES601Plus OPERATING MANUAL If set to "YES", this control will enable measurement of the line cord TEST resistance. For this type of test, resistance is measured between the protective LINE CORD earth terminal on the line cord connected to the test socket of ES601Plus, and TO EARTH: the Kelvin Cable which will be connected to a grounding stud or the metal enclosure of the DUT.
  • Page 76 ES601Plus OPERATING MANUAL MULTI LINE POINT- Test Protocol Test Application CORD TO-PT Measure resistance up to 10 times, PE test of permanently-installed between Kelvin Cable and "DUT equipment, followed by continuity test of CASE" lead. The OFFSET calibration earthed metal parts on the equipment. is subtracted from all measurements.
  • Page 77 ES601Plus OPERATING MANUAL CALIBRATE The "OFFSET:" displayed to the right of this control is the resistance of the test lead used in measuring point-to-point resistance. In a point-to- OFFSET: point test, the OFFSET calibration is subtracted from the measured resistance to obtain the result which is displayed by ES601Plus. Calibrate the OFFSET when required, particularly if the test lead used for point-to-point measurement is changed.
  • Page 78 ES601Plus OPERATING MANUAL This button on the Sequence Controls menu advances the test to the next NEXT: step. If the PETM accessory option is installed, you will first be prompted to select the test current if the safety standard is either IEC60601 or IEC61010.
  • Page 79 ES601Plus OPERATING MANUAL Fig u re 26 - Protective earth test result (multiple PE = "NO"). The limit for the protective earth test depends on the safety standard and type of limits (default, or user-defined) as selected on the MANUAL MODE menu. A value higher than the displayed limit produces a "FAIL"...
  • Page 80 ES601Plus OPERATING MANUAL Fig u re 27 - Protective earth test result (multiple PE = "YES"). The buttons provided on this result display are: Returns the display to the MANUAL MODE menu. Acquired ESCAPE: measurements are discarded and not saved to the Clip Record. REPEAT: Causes the displayed measurement to be repeated.
  • Page 81 DUT such as burning of internal components or other failures. If in doubt, contact the DUT manufacturer or supplier for guidance. Datrend Systems Inc. will not be responsible for damage resulting from incorrect application of this test.

  • Page 82: Leakage Current Test

    ES601Plus OPERATING MANUAL 5.10 Leakage Current Test Pressing the LEAKAGE CURRENT button on the MANUAL MODE menu allows you to set up the parameters for a leakage current test. Once the parameters have been set, the test itself will run as an automated sequence of measurements.
  • Page 83 ES601Plus OPERATING MANUAL If set to "ON", leakage tests are performed with the power switch of EQUIPMNT: the DUT in the "ON" position only. If set to "ON/OFF", leakage tests are performed with the DUT power switch "ON", and then the entire leakage test sequence is repeated after the DUT power switch is set to "OFF".
  • Page 84 ES601Plus OPERATING MANUAL If set to "TEST", measurement of patient leakage is enabled. If set to APPLIED PARTS: "DO NOT TEST", patient leakage is disabled. All safety standards require applied parts to be tested if the DUT provides applied parts (e.g.: ECG leads;...
  • Page 85 Otherwise, s e v e re d am ag e to th e DUT could result when AUX1 is activated during the test. If in doubt, contact the DUT manufacturer or supplier for guidance. Datrend Systems Inc. will not be responsible for damage resulting from incorrect application of this test.
  • Page 86 ES601Plus OPERATING MANUAL Aborts leakage measurement and returns to MANUAL MODE menu. ESCAPE: No leakage test data will be copied to the Clip Record. NEXT: Advances ES601Plus to the next step of the leakage test. If APPLIED PARTS is set to "DO NOT TEST", Sequence Controls for manual leakage testing will be displayed when the NEXT button is pressed.
  • Page 87 ES601Plus OPERATING MANUAL Buttons provided by the APPLIED PARTS editor are: Pressing this button causes the QWERTY touch keypad to be displayed. The AP1: user may enter up to seven letters and/or digits as a name for the patient- applied part (e.g. ECG lead; sensor; etc.) that you will connect to jack AP1 of ES601Plus.
  • Page 88 ES601Plus OPERATING MANUAL Fig u re 30 - Groups editor for applied parts. The buttons appearing on the GROUPS editor are: APPLIED PT GROUP: Selects the applied part group to be edited: 1, 2 3, 4 or 5. GROUP STATUS: Selects "ENABLED"...
  • Page 89 ES601Plus OPERATING MANUAL NUMBER OF LEADS: Determines the number of leads in the group being displayed. Leads are incorporated into the group consecutively, starting at jack AP1 on the front panel. The simplest permitted setup is one applied part (AP1) in one enabled group (Group 1).
  • Page 90 ES601Plus OPERATING MANUAL Fig u re 31 - Sequence Controls for manual leakage test. The buttons provided on the Sequence Control menu are: PAUSE AFTER After each measurement of the test, ES601Plus will pause for the MEASUREMENT: indicated time before proceeding with the next leakage measurement. The delay provided by this control allows the user to more easily interrupt a sequence in progress, so a particular leakage measurement of interest can be repeated as desired.
  • Page 91 ES601Plus OPERATING MANUAL If set to "YES", this control will override the power-up delay setting STOP AFTER described prior and will cause the test to fu lly s to p immediately after the SUPPLY ON: AC supply is connected to the DUT by ES601Plus. ES601Plus will prompt the user to activate the DUT and will not proceed until the user acknowledges by pressing the CONTINUE button.
  • Page 92 ES601Plus OPERATING MANUAL Fig u re 32 - DUT connection instructions for IEC60601 test. According to the CONNECTIONS menu, at minimum an IEC60601 test will require the user to connect the DUT to the test socket and the Kelvin Cable of ES601Plus to the enclosure of the DUT.
  • Page 93 ES601Plus OPERATING MANUAL Once the leakage test has been set up and the connections are made, the test is started by pressing the CONTINUE button on the CONNECTIONS menu. The required measurements are performed automatically in a sequence. AC RMS and DC currents are measured simultaneously, and the display is updated with new data approximately two times every second.
  • Page 94 ES601Plus OPERATING MANUAL Fig u re 34 - Leakage test paused during sequence. Individual leakage readings are rapidly made by ES601Plus, each reading usually requiring less than one second. If it is expected you may want to pause individual values during a test in order review them, you should set the "PAUSE AFTER..."...
  • Page 95 ES601Plus OPERATING MANUAL For IEC60601 and AAMI-ES1 standards, AC supply conditions will be tested in the following order, according to test conditions initially specified by the user on the leakage setup menu: Reverse polarity; Line 2 (neutral) in single-fault condition (RP:SF L2O) Reverse polarity;...
  • Page 96 ES601Plus OPERATING MANUAL The leakage sequence proceeds with NC tests after you press CONTINUE. Alternatively, you may press ESCAPE to abort the leakage test and return to the MANUAL MODE menu. Note the purpose of the "STOP AFTER..." break is to allow you activate a DUT which cannot be switched ON until a full AC supply is provided to the DUT.
  • Page 97 ES601Plus OPERATING MANUAL Fig u re 37 - Switch DUT to "ON" for upcoming SF:L2O tests. Note the purpose of the "STOP BEFORE..." break is to allow you to accommodate power-sensitive equipment, such as a personal computer or equivalent DUT, which cannot be arbitrarily disconnected from the AC supply without potentially damaging the DUT.
  • Page 98 ES601Plus OPERATING MANUAL Fig u re 38 - Switch DUT to "OFF" for "DUT OFF" tests. Upon pressing CONTINUE on the above menu, ES601Plus repeats all leakage tests that were enabled by the user. Since the DUT power switch remains "OFF" for all measurements, ES601Plus does not stop when the AC supply is changed and no further breaks in the sequence occur until the end of the test.

  • Page 99: Viewing The Clip Record

    ES601Plus OPERATING MANUAL 5.11 Viewing the Clip Record At any time during manual testing, device information and safety test data accumulated in the Clip Record may be examined by pressing the VIEW RECORD button on the MANUAL MODE menu. The Clip Record data will be shown on the LCD as a multi-page Test Record report. This is the same display as would result from recalling a Test Record from flash memory for viewing or printing.
  • Page 100 ES601Plus OPERATING MANUAL The options available on the SAVE TEST RECORD menu are: This selection opens the DEVICE INFO menu as described earlier in DEVICE EDIT: this chapter. ERASE MEMORY: Opens the Erase Memory menu. The user is provided with options for erasing the last (i.e.

  • Page 101: Reviewing Tests

    ES601Plus OPERATING MANUAL 5.13 Reviewing Tests Test Records which have been saved to the flash memory of ES601Plus may be recalled by pressing the REVIEW TESTS button on the MANUAL MODE menu. A particular Test Record can be located by scrolling up or down using the scroll buttons, until the desired Test Report is highlighted. Display the Test Report by pressing the SELECT RECORD button.
  • Page 102 ES601Plus OPERATING MANUAL Buttons provided on the TEST RECORDS menu are: This button accesses a menu for erasing the record which is currently ERASE MEMORY: selected on the TEST RECORDS menu, or all of the records stored in memory. The ERASE MODE button on this menu allows the user to toggle between the currently-selected record or “ERASE ALL RECORDS”.
  • Page 103 ES601Plus OPERATING MANUAL Allows scrolling through the Records, either by single record (up SCROLL BUTTONS: or down ) or by page (10 records up or down Returns to the MANUAL MODE menu. ESCAPE: Opens the COMPUTER INTERFACE menu to allow for COMPUTER communication with the ES601pc software.

  • Page 104: Viewing Test Data And Report Output

    ES601Plus OPERATING MANUAL 5.14 Viewing Test Data and Report Output 5.14.1 Viewing a Record Previously-saved Test Records may be recalled from the flash memory as described in the immediately preceding section. The current contents of the Clip Record may also be viewed while testing is in progress, via the VIEW RECORD button on the MANUAL MODE menu.
  • Page 105 ES601Plus OPERATING MANUAL Buttons provided by the TEST RECORD display are: Returns to the MANUAL MODE menu. ESCAPE: OUTPUT Enters the REPORT OUTPUT menu, which allows a formatted report of the test results to be printed via the Printer Port or RS-232 Port of REPORT: ES601Plus.
  • Page 106 ES601Plus OPERATING MANUAL Fig u re 42 - Example of earth leakage and touch current results. For IEC62353 and VDE0751 safety standards, the test condition for the leakage results may be shown as "ALTERNATIVE METHOD", if the Alternative Method of device leakage or patient leakage testing was selected by the user for the test.
  • Page 107 ES601Plus OPERATING MANUAL For each supplementary test condition enabled by the user in the test setup, ES601Plus measures all combinations of the supplementary condition with the AC supply conditions specified in the safety standard. ES601Plus then records the AC and DC leakage results for the supplementary condition that produced the highest leakage.
  • Page 108 ES601Plus OPERATING MANUAL auxiliary leakage results, with one page being provided for each individual patient lead or applied part. Fig u re 44: Example of auxiliary leakage results (1 page per Part). Additional pages may follow the safety test data if results were obtained from automated ECG and/or procedural tests.

  • Page 109: Report Output

    ES601Plus OPERATING MANUAL Fig u re 46: Example of automated procedure results. 5.14.2 Report Output A hardcopy of the results shown on the LCD may be output to either the Printer Port or the RS-232 Port of ES601Plus by pressing the OUTPUT REPORT button on the Test Record screen. Fig u re 47 - Select Printer Port Manual Testing/Chapter 5 # Page 90...
  • Page 110 ES601Plus OPERATING MANUAL NOTE: If outputting the report to a serial printer, the printer’s serial protocol must be configured for: 9600 baud, No Parity, 8 data bits, and 1 stop bit, or: 9600,N,8,1 The buttons provided on the REPORT OUTPUT menu are: Return to Test Record view screen ESCAPE: SELECT PORT:...

  • Page 111: Using Hyperterminal To Capture Test Results

    ES601Plus OPERATING MANUAL 5.14.3 Using HyperTerminal to Capture Test Results In some situations, the user may not have access to a personal computer which has the ES601pc software package installed on it. As an alternative to utilizing the ES601pc software to download Test Record data from ES601Plus, a terminal emulation program such as Windows 98/2000/XP HyperTerminal may be used to receive Test Records transmitted over RS-232 by the REPORT OUTPUT menu, and then save the data to a text file.
  • Page 112 ES601Plus OPERATING MANUAL In the HyperTerminal program window, click on Transfer in the menu bar and click on Capture Text to save all Test Records to a file. In the File box, type a descriptive name for the file, and click Start. HyperTerminal is now ready to receive data sent from ES601Plus to the PC.

  • Page 113: Ecg Simulator

    ES601Plus OPERATING MANUAL 5.15 ECG Simulator Output signals from the ECG simulator of ES601Plus are available at the AP jacks located on the front panel of the unit. Before using the simulator, connect the patient monitoring device under test to the corresponding ECG signals at the AP jacks ("RA" for right arm etc.). The AP connections are safety-style female banana jacks;...
  • Page 114 ES601Plus OPERATING MANUAL SINE WAVE Sine Wave, 0.5 Hz (e) Sine Wave, 10 Hz (e) Sine Wave, 20 Hz (e) Sine Wave, 40 Hz (e) Sine Wave, 50 Hz (e) Sine Wave, 60 Hz (e) Sine Wave, 70 Hz (e) Sine Wave, 100 Hz (e) SINUS RHYTHM ECG, 30 BPM (f)
  • Page 115 ES601Plus OPERATING MANUAL The following table describes specific instances where the waveforms listed prior are especially useful. The letter, below, corresponds to the letter at the end of each waveform description prior. Tests monitor/chart recorder low-frequency performance Tests monitor/chart recorder gain and damping performance Tests monitor/chart recorder linearity performance Tests monitor R-wave detection performance Tests monitor/chart recorder frequency response...

  • Page 116: Technician Timer

    ES601Plus OPERATING MANUAL The ESCAPE key may be pressed on any submenu to return to the main ECG menu. On the main ECG menu, pressing ESCAPE returns the display to the MANUAL MODE menu. When manually operating the ECG Simulator via the prior menu system, it is not possible to save "ECG test results"...
  • Page 117 ES601Plus OPERATING MANUAL Manual Testing/Chapter 5 # Page 98...

  • Page 118: Automated Testing

    ES601Plus OPERATING MANUAL Automated Testing 6.1 Automated Testing with ES601Plus AUTOSEQUENCE MODE can be entered from either the power-on STARTUP menu, or by pressing the AUTO MODE button on the MANUAL MODE menu of ES601Plus. This menu allows the user to select various automated tests as well as administrative functions (System Settings, Review Tests, etc.) as previously described in Chapter 5.
  • Page 119 ES601Plus OPERATING MANUAL Safety AutoSequences can be programmed as desired by means of System Settings Menu #2 (see Section 3.6). Alternatively, Safety AutoSequences can be edited and uploaded to ES601Plus by means of the Safety Autosequence plug-in of the ES601pc software package. ES601pc is described fully in Chapter 8.
  • Page 120 ES601Plus OPERATING MANUAL Fig u re 55 - Connections for IEC60601 test. If applied parts have been specified in the AutoSequence setup, the next menu displayed will show the applied part configuration. Applied part names may be modified by means of the menu. Applied part assignment to functional groups and protection class (B;...
  • Page 121 ES601Plus OPERATING MANUAL The final setup menu displayed before the test actually starts shows the Sequence Controls of the AutoSequence. These settings are described in more detail in Sections 3.3, 5.9 and 5.10 of this manual. Any changes made to these settings are retained for the duration of the test, and revert to the values stored in memory upon test completion.
  • Page 122 ES601Plus OPERATING MANUAL Step Safety Measurement AC supply to DUT Protective earth Insulation resistance Line voltage Leakage (RP:SF L2O) Leakage (RP:NC) Leakage (NP:SF L2O) Leakage (NP:NC) Load current Test completion Throughout the test sequence, PAUSE, ESCAPE, REPEAT and CONTINUE buttons are available as applicable to the test being performed.

  • Page 123: Ecg Autosequences

    ES601Plus OPERATING MANUAL 6.1.2 ECG AutoSequences ES601Plus provides six programmable ECG AutoSequences, each with up to 24 waveform/amplitude steps. When an ECG AutoSequence is run, the waveform, amplitude scale, and pass/fail result for each sequence step will be stored in the Clip Record, along with measurement data that may have been previously acquired from a Safety AutoSequence or other automated tests.
  • Page 124 ES601Plus OPERATING MANUAL Fig u re 60 - ECG AutoSequence in progress. Throughout the ECG AutoSequence, PASS, FAIL and FAULT FOUND AND CORRECTED buttons are available. "Pass" indicates the DUT reflects the waveform as produced by ES601Plus. "Fail" indicates the waveform is not correctly displayed on the DUT. "Fault Found and Corrected" indicates the problem causing what would normally be a failure was resolved (such as a bad lead that was replaced) during the test.

  • Page 125: Other Autosequences

    ES601Plus OPERATING MANUAL 6.1.3 Other AutoSequences In addition to Safety Autosequences and ECG Autosequences, ES601Plus optionally provides for other types of automated tests. On its left side panel, ES601Plus provides six RS232 Tester Ports which can be connected to external measuring instruments (Analyzers, or "Testers") by means of accessory adapter cables.
  • Page 126 ES601Plus OPERATING MANUAL Select the desired submenu of sequences by pressing the button to the left of the submenu title. If the optional accessory feature associated with the AutoSequence menu has not been installed in ES601Plus, this will be indicated on the LCD as "(NOT INSTALLED)". In this case, the AutoSequence submenu will not be selectable.
  • Page 127 ES601Plus OPERATING MANUAL Fig u re 63 - Inspection in progress, "Pass/Fail" instruction. The buttons that may potentially appear on the LCD, depending on the Instruction being executed at each step, are as follows: Records an "OK" in the Clip Record for the current step, and advances the test to the next step.
  • Page 128 ES601Plus OPERATING MANUAL BACK: Goes back to the immediately previous step of the test. Records "SKIPPED" in the Clip Record for the current step, and advances the test SKIP: to the next step. This button could be pressed if the instruction displayed cannot be performed, or is not applicable to the DUT.
  • Page 129 ES601Plus OPERATING MANUAL Similar to a General Inspection, when a Tester AutoSequence is run, the user may be presented with OK, PASS, FAIL and other buttons on the LCD as each step of the AutoSequence is executed. ESCAPE, BACK and SKIP buttons are also available and will function as described previously. At particular steps in the sequence, remote control commands may be transmitted from ES601Plus to the attached Tester, via one of the RS232 Tester Ports on ES601Plus (see Chapter 4).
  • Page 130 ES601Plus OPERATING MANUAL During the AutoSequence, menus displayed will depend on the tester being controlled and the test parameters which have been programmed by the user as part of the AutoSequence setup. Fig u re s 66 - 70 show how the test process works for the case of Infutest 2000 analyzing the flow rate performance of a 2-channel infusion device (4-channel pumps can also be tested this way using Infutest 2000 with RSM).
  • Page 131 ES601Plus OPERATING MANUAL Fig u re 68: ES601 monitors Infutest status while Infutest tests the IV pump. Fig u re 69: After Infutest is finished, ES601 downloads measurement data. Automated Testing/Chapter 6 # Page 112...
  • Page 132 ES601Plus OPERATING MANUAL Fig u re 70: ES601 automatically passes or fails the final test results. If one or more of these Datrend-specific tester options are installed, the ES601pc software package will provide an easy-to-use interface for creating test sequences to meet virtually any need. For instructions on programming Oxitest, Infutest or Phase3 AutoSequences, refer to the Help menus included with the corresponding 'plug-in' module of ES601pc.

  • Page 133: Test Procedures

    ES601Plus OPERATING MANUAL 6.1.4 Test Procedures A Test Procedure can integrate visual inspection, safety testing, ECG testing, and performance testing activities into one comprehensive procedure targeted at a specific kind of medical device, for example, a patient monitor, defibrillator, anaesthesia gas machine, infusion pump, etc. The flash memory of ES601Plus provides storage of up to 500 Test Procedures.
  • Page 134 ES601Plus OPERATING MANUAL Increment/decrement buttons on the Test Procedure menu allow a Test Procedure title to be highlighted in the list. The Test Procedure is then initiated by pressing the SELECT button. ESCAPE returns the display to the AUTOSEQUENCE MODE menu. Similar to a General Inspection, when a Test Procedure is run, the user may be presented with OK, PASS, FAIL and other buttons on the LCD as each step of the Test Procedure is executed.

  • Page 135: Automated Testing Principles

    ES601Plus OPERATING MANUAL 6.2 Automated Testing Principles ES601Plus provides automated testing through General Inspections, Tester AutoSequences, and Test Procedures. Each type of automated test is based on a sequential list of In s tru c tio n s that an operator can step through using ES601Plus touch screen interface.

  • Page 136: Tester Autosequences

    ES601Plus OPERATING MANUAL 6.2.3 Tester AutoSequences ES601Plus provides automated test sequences for medical device analyzers and testers such as IV Pump Testers, Pulse Oximeter Testers, Defibrillator Testers, ESU Testers, NIBP Testers, plus many others. To accommodate any make or model of test equipment you may own, ES601Plus provides five sets of User-Defined Tester AutoSequences, which you can arbitrarily program as desired using the AutoSequence Editor of ES601pc.

  • Page 137: Instruction Specifications

    ES601Plus OPERATING MANUAL 6.2.5 Instruction Specifications In this section, the capabilities and features of ES601Plus Instruction set are explained. Examples of LCD displays are given for the case of a Test Procedure. Instructions will operate the same way for General Inspections and Tester AutoSequences, the only difference being the title shown at the top of the LCD display.

  • Page 138: The K Instruction

    ES601Plus OPERATING MANUAL 6.2.5.2 The K Instruction The user interface for the K Instruction, which is intended for displaying comments, prompts or setup instructions, is shown in Fig u re 73. Fig u re 73 - Test Procedure in progress, K instruction. The buttons provided for the K Instruction are ESCAPE and BACK, plus an OK button.

  • Page 139: The I Instruction

    ES601Plus OPERATING MANUAL 6.2.5.3 The I Instruction The I Instruction prompts the user to enter information or comments (Fig u re 74). The requested information can be entered by means of the QWERTY touch keypad displayed on the LCD, or by means of an external PS/2 keyboard connected to ES601Plus.

  • Page 140: The E Instruction

    ES601Plus OPERATING MANUAL 6.2.5.4 The E Instruction The operator interface of the E Instruction (Fig u re 75) allows the user to optionally enter measurement results or other data into ES601Plus, and then "pass" or "fail" the entered data. Data entered by the user and the pass/fail assessment are then saved as the test result for that step.

  • Page 141: The C Instruction

    ES601Plus OPERATING MANUAL 6.2.5.5 The C Instruction The C Instruction will cause ES601Plus to transmit a remote control command to an external device, such as a medical device analyzer or "tester", which ES601Plus expects to be connected to the RS232 Tester Port (#1 through #6) specified in the AutoSequence or Test Procedure setup. The C Instruction incorporates a command (data which will be transmitted to the external Tester), and a prompt.

  • Page 142: The R Instruction

    ES601Plus OPERATING MANUAL 6.2.5.6 The R Instruction The R Instruction combines features of the C Instruction (remote control) and the E Instruction (data entry). The user interface for the R Instruction is the same as that for the E Instruction. The R Instruction can be useful with patient simulators (e.g.

  • Page 143: The M Instruction

    ES601Plus OPERATING MANUAL 6.2.5.7 The M Instruction The M Instruction can retrieve test result data from an external medical device analyzer or "tester", after the tester has been set up and used to perform a test. Typically, an M Instruction might follow one or more C Instructions in an AutoSequence or Test Procedure.

  • Page 144: The D Instruction

    ES601Plus OPERATING MANUAL 6.2.5.8 The D Instruction The D Instruction can be used to provide timed delays in Tester AutoSequences and Test Procedures (Fig u re 78). The delay of the Instruction may range from 1 to 32000 seconds. The instruction also provides a prompt which is displayed on the LCD as the "TASK"...

  • Page 145: The A Instruction

    ES601Plus OPERATING MANUAL 6.2.5.9 The A Instruction The A Instruction is utilized o n ly in T e s t Pro c e d u re s and allows ES601Plus to invoke a Safety AutoSequence, a ECG AutoSequence, or Tester AutoSequences from within the procedure.
  • Page 146 ES601Plus OPERATING MANUAL Command prefix Type of AutoSequence "NN" Safety 01 to 24 01 to 12 General Inspection 01 to 18 Pulse Oximeter Tester 01 to 12 IV Pump Tester 01 to 12 Defibrillator Tester 01 to 24 NIBP Monitor Tester 01 to 12 ESU Tester 01 to 12...
  • Page 147 ES601Plus OPERATING MANUAL When an A Instruction is executed, the type of AutoSequence is displayed on the LCD as the "TASK", the title and number of the AutoSeqeuence are also shown. A SKIP button allows the AutoSequence to be bypassed. Pressing the CONTINUE button runs the displayed AutoSequence. BACK and ESCAPE keys assume the same functions described previously for other Instructions.

  • Page 148: Instruction Summary

    ES601Plus OPERATING MANUAL 6.2.5.10 Instruction Summary Op Code Instruction Type Buttons shown on LCD Run AutoSequence ESCAPE; BACK; SKIP; CONTINUE Tester Remote Control If no tester response: ESCAPE; BACK; NEXT Timed Delay, in seconds ESCAPE; BACK; SKIP Data Entry with Pass/Fail ESCAPE;...

  • Page 149: Equipment Records

    ES601Plus OPERATING MANUAL 6.3 Equipment Records Equipment Records are an optional accessory feature that can be installed in ES601Plus. With this accessory installed, ES601Plus can store up to 18,432 Equipment Records, these Records containing the control number of a medical device and a reference to an ES601Plus Test Procedure (ranging from 1 to 500).
  • Page 150 ES601Plus OPERATING MANUAL Fig u re 81 - Device Info menu, following entry of valid Device ID. Pressing the RUN TEST button on the menu will initiate the associated Test Procedure and, when the test is completed, the SAVE TEST RECORD menu will be displayed. If, after opening the DEVICE INFO menu, the Device ID (Control) Number is changed, the indicated Test Procedure will still run and, when saved, will display the edited Device ID (Control) Number.
  • Page 151 ES601Plus OPERATING MANUAL Automated Testing/Chapter 6 # Page 132...

  • Page 152: Computer Control

    ES601Plus OPERATING MANUAL Computer Control 7.1 Overview of Computer Control ES601Plus provides a communications interface that allows personal computer (PC) software to control the safety analyzer and acquire measurement data in realtime as safety tests are being performed. Although a terminal emulation program such as Windows HyperTerminal may be used to operate ES601Plus in this manner, computer control is more suited to users who intend to develop their own PC software to satisfy particular testing or documentation requirements.

  • Page 153: Connections

    ES601Plus is DB9 female, which is compatible with USB-to-Serial converter cables. For connection to a physical COM Port at the PC, use a standard DB9F-DB9M serial cable. Do not use a NULL-modem cable for this connection. A suitable serial cable is available from Datrend Systems as Part Number 3140-010.

  • Page 154: Safety Test Execution

    ES601Plus OPERATING MANUAL 7.4.2 Safety Test Execution Under computer control, a Safety AutoSequence is initiated by means of this exchange: PC software transmits RSAF\r to ES601Plus via the serial connection. ES601Plus responds by returning (0x2A 0x0D) to the PC. If the RSAF\r command is received by ES601Plus without errors, the *\r response should be returned to the PC within 0.2 seconds.

  • Page 155: Test Report Download

    ES601Plus OPERATING MANUAL In response to the sequence character from the PC, ES601Plus initiates the test and within one second or less returns a message specifying the safety standard of the selected sequence, for example: STD, IEC60601\r After this step, the user may operate ES601Plus via the touch screen in the conventional manner, responding to prompts displayed by ES601Plus as described in Chapter 5.

  • Page 156: Format Of Measurement Data

    ES601Plus OPERATING MANUAL In response to this command, ES601Plus will internally generate and then transmit a complete Test Report document as ASCII text to the PC. The format of this report is highly dependent on the safety standard, but will be the same as the document that could otherwise be obtained by printing a Test Record saved earlier for a similar type of safety test.
  • Page 157 ES601Plus OPERATING MANUAL LEA,O??/?P/L2?/E?/AP?/X1?/X2?,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Earth, IEC60601/AAMI LPA,O??/?P/L2?/E?/AP?/X1?/X2?,GPx,APyy,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Patient, IEC60601/AAMI LAX,O??/?P/L2?/E?,APyy,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Auxiliary, IEC60601 LLD,O??/?P/L2?/E?,APyy,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Interlead, AAMI LDV,ON/?P/L2N/EO,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Device VDE/IEC62353 (direct method) LDV,ALTERNATE METHOD,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Device VDE/IEC62353 (alternate method) LPA,ON/?P/L2N/EN/AP?,GPx,APyy,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Patient VDE/IEC62353 (direct method) LPA,ALTERNATE METHOD,GPx,APyy,<value>,<limit>,[uArms|uAdc],[P|F]\r Leakage, Patient VDE/IEC62353 (alternate method)
  • Page 158 ES601Plus OPERATING MANUAL For leakage measurements, a special data field specifying the leakage test conditions immediately follows the 3-character prefix; the individual conditions are separated by the slash character /, and the variable characters for a given condition are represented by: ?. The mnemonics of this field are interpreted as follows: Mnemonic Pertinent Test Condition...
  • Page 159 ES601Plus OPERATING MANUAL Computer Control/Chapter 7 # Page 140...

  • Page 160: Es601Pc Software

    ES601Plus OPERATING MANUAL ES601pc Software Datrend Systems ES601pc software provides a communication utility for ES601Plus and allows the user to configure Safety AutoSequences, electrocardiogram (ECG) AutoSequences, Test Reports, General Inspections, Tester AutoSequences and Test Procedures of ES601Plus Safety Analyzer. The first three of these utilities are standard features of the ES601pc software and will be available for use immediately upon installation.

  • Page 161: Installing Usb Drivers

    ES601Plus OPERATING MANUAL Fig u re 82 8.2 Installing USB Drivers When installation is complete, connect ES601Plus to your PC using the USB cable provided. When ES601Plus is connected to the PC for the first time, Windows should detect the connection and automatically launch the New Hardware Wizard which will prompt you for the USB driver.

  • Page 162: Running Es601Pc

    ES601Plus OPERATING MANUAL The USB drivers for ES601Plus are provided on the USB with the ES601pc software. When the Hardware Wizard asks for the files, direct the Hardware Wizard to your USB drive, or to the location where the files were downloaded. The Wizard should find and install the required driver files.
  • Page 163 ES601Plus OPERATING MANUAL Fig u re 86 ES601pc Main Screen * Note that the Sentinel Converter button is now titles CMMS Interface. From the Menu Bar in the ES601pc application the following options are available: Tools From this drop-down you can select the following utilities: Set the Background Image –...

  • Page 164: Backup And Restore

    ES601Plus OPERATING MANUAL 8.4 Backup and Restore In addition to the Exit Program and the Help buttons on the application window, a Backup And Restore button is provided. When changes are made with the various Editors, the changes are saved immediately, as the changes are made.

  • Page 165: Editing The Autosequence Title

    ES601Plus OPERATING MANUAL 8.5.1 Editing the AutoSequence Title The sequence title can be modified by first selecting the sequence in the Safety Autosequence dropdown menu. Press the "Edit Autosequence Title" button and a window will appear, prompting you to enter a new autosequence title. The two lines can hold up to 20 characters each. Fig u re 88 8.5.2 Choosing the Standard To choose a standard, use the Standard dropdown menu.

  • Page 166: Limits (All Standards)

    ES601Plus OPERATING MANUAL 8.5.3 Limits (All Standards) The limits of each test can be set to the values specified by the Standard, or user-defined limits may be selected using the Safety Limits Editor. 8.5.4 Equipment Class (IEC60601, AAMI-ES-1, VDE0751 and IEC62353) A Class I device has a protective earth conductor (AC supply has 3 wires).

  • Page 167: Load Current

    ES601Plus OPERATING MANUAL 8.5.7 Load Current (IEC60601, AAMI-ES1, VDE0751, IEC62353 and IEC61010) Load Current is a test where ES601Plus connects an internal ammeter to the DUT and measures the current drawn from the AC line when the DUT is powered and running. This test can be enabled under the Load Current radio group by selecting Measure, or disabled by selecting Skip.

  • Page 168: Leakage Current (Iec61010)

    ES601Plus OPERATING MANUAL 8.5.12 Leakage Current (IEC61010) If the Leakage Current checkbox is checked, ES601Plus will perform only an Enclosure Leakage Current test. A point-to-point Enclosure Leakage test may be optionally enabled. Conditions of the AC power supply for these leakage tests can be set under the Supply Conditions panel. Note the Device Power condition is ON, according to the requirements of IEC61010.

  • Page 169: Patient-Applied Parts

    ES601Plus OPERATING MANUAL 8.5.17 Patient-Applied Parts (all standards except IEC61010) This test is enabled by checking the Patient-Applied Parts box, unless the safety standard is one of the "-BAT" standards, in which case this test is always enabled. In this test, ES601Plus measures the current that flows out of the applied parts of the DUT through the human body load, when the parts are either connected to protective earth, or they are connected to an isolated mains supply (isolated AC line).

  • Page 170: Auxiliary (Interlead) Leakages

    ES601Plus OPERATING MANUAL Type BF refers to "Body-Floating" or "Isolated" protection class. That is, the applied parts are electrically isolated from protective earth but are not intended for direct contact with cardiac tissue. ES601Plus will measure patient leakage current while all the applied parts in the Type BF applied part Group are shorted to ground, or alternatively to the isolated mains (AC supply).

  • Page 171: Protocol (Vde0751 And Iec62353)

    ES601Plus OPERATING MANUAL 8.5.22 Protocol (VDE0751 and IEC62353) The Protocol defines the device and patient leakage measurement protocols under VDE0751 and IEC62353 safety standards. In the VDE Alternate Method, the DUT is connected to an isolated mains source rather than the AC supply. In the Direct Method, the DUT is powered by the AC supply, and patient leakage is determined by connecting isolated applied parts to mains only (Type B parts are not tested).

  • Page 172: Printing Autosequences

    ES601Plus OPERATING MANUAL 8.5.26 Printing AutoSequences Press the Print button to show the print dialogue. Select the current sequence radio button and press OK to print out the current AutoSequence. Select the All Sequences radio button and press OK to print out all 24 AutoSequences.

  • Page 173: Editing The Autosequence Title

    ES601Plus OPERATING MANUAL Fig u re 89 8.6.1 Editing the AutoSequence Title The AutoSequence title can be modified by first selecting the sequence in the ECG Sequence dropdown menu. Press the "Edit Autosequence Title" button and a window will appear prompting you to enter a new autosequence title (see Fig u re 90).

  • Page 174: Removing A Waveform

    ES601Plus OPERATING MANUAL Optionally, you can select a waveform from the Simulator Waveforms pane, and drag and drop the waveform to the Waveform Sequence pane. The waveform will appear in the Waveform Sequence window at the end of the sequence. 8.6.3 Removing a Waveform Select a waveform in the Waveform Sequence pane (on the right side of the screen) and press the "Remove"...

  • Page 175: Downloading Autosequences

    ES601Plus OPERATING MANUAL 8.6.7 Downloading AutoSequences Sometimes it is desirable to download sequences stored in ES601Plus. You can do this by pressing the "Download From ES601" button. Choose to download via USB, Ethernet, or Serial Port. Doing so will overwrite the configuration of all 6 ECG AutoSequences in ES601pc with the sequences stored in ES601Plus.
  • Page 176 ES601Plus OPERATING MANUAL Fig u re 91 Fig u re 92 After pressing "Connect", a message box with a transfer progress bar will appear (see Fig u re 92). After the transfer is complete, each test report will appear as a row denoted by the test number, parent I.D., device I.D., date, device description, make, and model (see Fig u re 93).

  • Page 177: Searching For Test Reports

    ES601Plus OPERATING MANUAL ‘Pass’ Indication On the right side of the list of test reports that have been downloaded is a column labelled ‘Pass’. If this column contains a green check mark, then all components of the test have been given a pass indication during the test on ES601Plus.

  • Page 178: Opening Existing Test Reports

    ES601Plus OPERATING MANUAL the gray "Cancel Search" button to the right of the search box. The filter looks at ALL the fields listed prior and performs a non-case sensitive, sub-string search for the search text string. As the search string is input, the filtered result appears on the screen (the speed of the search will depend on the number of records, and the filtered result may be slightly delayed).

  • Page 179: Viewing Test Reports

    ES601Plus OPERATING MANUAL Test Reports opened in this way are ‘temporary’, in they are not added to the list of reports shown on the screen. Attempting to open a file that is not TEXT-only may cause the ES601pc program to crash. Ensure only ES601Plus test report text files are selected for viewing.

  • Page 180: Printing Test Reports

    ES601Plus OPERATING MANUAL 8.7.5 Printing Test Reports In the Test Report Viewer, press the "Print" button to show the print dialogue. Select the printer and press OK to print all the test reports currently in the viewer. Pressing Cancel will close the print dialogue without printing.

  • Page 181: Autosequence Editor

    ES601Plus OPERATING MANUAL Saving to CSV Saving test reports in CSV is exactly like saving to text format, except a CSV file is also created listing each device and a path to the test report file for that device. Each line of the CSV file consists Device ID, Test Date, Test Time, Overall Pass, Tech, Description, Make, Model, Serial Number, Facility, Location, Info Edited, Parent ID, Tech Time, Filename and Path.

  • Page 182: Editing An Autosequence

    ES601Plus OPERATING MANUAL Selecting the User Tester Sequence tab will open that window. To edit a User Tester Sequence, first expand one of the five User Tester Sequences by clicking on the plus symbol next to the User Tester name. Now select the User Tester Sequence and press Edit Sequence, or double-click on the sequence.

  • Page 183: Editing An Instruction

    ES601Plus OPERATING MANUAL All instructions can be removed from the AutoSequence by pressing the Clear button in the center margin. AutoSequence contents can be re-ordered by selecting the desired Instruction in the AutoSequence and using the Up or Down arrows below the column to move the selected item up or down.

  • Page 184: Selecting The Op Code

    ES601Plus OPERATING MANUAL Fig u re 99 8.8.3.1 Selecting the Op Code The Op Code defines what the Instruction does and which buttons are presented to the user on ES601Plus display. Depending on the op code, the user may be required to enter a measurement value or comment when that Instruction is encountered during the Test Procedure.

  • Page 185: Entering The Command/Prompt

    ES601Plus OPERATING MANUAL Fig u re 100 In the Instruction Editor, select a Category of an Instruction via the Category drop-down menu. Create a new category in the Instruction Editor by pressing "New Category". The Category Editor will appear. Type in a new category name in the Category Name textbox, and select the associated category letter in the Category Designation Letter dropdown.

  • Page 186: Filtering The Instructions

    ES601Plus OPERATING MANUAL 8.8.5 Filtering the Instructions Press "Filter Instructions". The Instruction Filter window will appear (see Fig u re 101). Under the Basic Filter tab, select a Category and/or an Op Code and then press "OK". Only the instructions with the selected category or op code will appear in the Available Instructions window.

  • Page 187: Importing Instructions

    ES601Plus OPERATING MANUAL 8.8.7 Importing Instructions Instructions can be imported from a CSV (Comma Separated Values) file and added to the instruction table. Press "Import Instructions" and browse for the CSV file. For the import to be successful, the CSV file must list instructions in the following format: [Category],[Op Code],[Command] where [Category] is a single capital letter denoting the category designation.

  • Page 188: Uploading Autosequences

    ES601Plus OPERATING MANUAL 8.8.9 Uploading AutoSequences To upload the sequences to ES601Plus, press the "Upload To ES601" button. Choose uploading via USB, Ethernet, or Serial Port, and then press "Connect". If the connection is via ethernet, enter in the IP address assigned to ES601Plus (the IP address of ES601Plus is displayed on the LCD when ES601Plus is operating in Ethernet Mode).

  • Page 189: Test Procedure Editor

    ES601Plus OPERATING MANUAL Fig u re 105 8.9 Test Procedure Editor The optional Test Procedure Editor allows the user to create and edit up to 500 Test Procedures for ES601Plus as described in Chapter 6 of this manual. Pressing TEST PROCEDURE EDITOR from the main menu of ES601pc will display the Test Procedures screen which lists all available Test Procedures.
  • Page 190 ES601Plus OPERATING MANUAL Fig u re 107 Note: In Fig u re 107 the example procedure shown contains an AutoSequence with a "SAF01" Command. This is an Instruction to perform Safety AutoSequence #01 from the available list of 24 Safety Autosequences. To run an AutoSequence from within a Test Procedure, an Instruction to invoke that AutoSequence must first be created in the Instruction List.
  • Page 191 ES601Plus OPERATING MANUAL The type of AutoSequence and the related commands that are generated by the Instruction Editor are as follows: Type Autosequence "nn" Safety 01 to 24 01 to 12 General Inspection 01 to 18 Pulse Oximeter Tester 01 to 12 IV Pump Tester 01 to 12 Defibrillator Tester...
  • Page 192 ES601Plus OPERATING MANUAL Selecting an “(unused)” Test Procedure from the list will open the editor window with no Instructions in the Test Procedure Contents (see Fig u re 108). The Title, Tester Port and Baud Rate can be changed in this screen, and Instructions can be added to the list on the right to create a custom Test Procedure.
  • Page 193 ES601Plus OPERATING MANUAL ES601pc Software/Chapter 8 # Page 174...

  • Page 194: Calibration And Maintenance

    . For calibration or service assistance, contact Datrend for a Return Materials Authorization (RMA) number and the location of the nearest Service Facility. Datrend Systems Inc. 5355 Parkwood Place Richmond, BC • CANADA • V6V 2N1 Tel: 800-667-6557 (North America Only) or 604-291-7747 •...
  • Page 195 ES601Plus OPERATING MANUAL ES601pc Software/Chapter 8 # Page 176...

  • Page 196: Appendix A. Safety & Ecg Autosequences

    ES601Plus OPERATING MANUAL APPENDIX A. Safety & ECG AutoSequences The following are the default Safety AutoSequences of ES601Plus. ES601Plus is supplied with these AutoSequences pre-loaded in the flash memory. The default AutoSequences may be modified using the ES601pc software, supplied on CDROM with ES601Plus. AutoSequences in the following list are identified as "SAFETY AUTOSEQUENCE #NN (SAFNN)."...
  • Page 197 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 2 (SAF02) IEC601 CHASSIS LKG, INSULATION, & GND Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Skip Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 198 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 4 (SAF04) IEC601 SAFETY TEST 5 LEADS (ECG) Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 199 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 5 (SAF05) IEC601 SAFETY TEST 10 LEADS (ECG) Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 200 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 6 (SAF06) IEC601 DEFIB SAFETY 5 LD ECG & PADDLES Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 201 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 7 (SAF07) IEC601 DEFIB SAFETY 5 LD ECG,PADS,SPO2 Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 202 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 8 (SAF08) IEC601 NIBP MONITOR WITH TEMP & SPO2 Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 203 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 9 (SAF09) IEC601 MULTIPARAM MONITOR: ECG,BP,TEMP Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 204 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 10 (SAF10) IEC601 MULTIPARAM MONITOR W. ETHERNET Standard: IEC60601 Limits Used: IEC60601 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 205 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 11 (SAF11) IEC601 BAT-POWERED ECG TELEMETRY, 3 LD Standard: IEC601-Battery Limits Used: IEC 60601 Limits Device Power: On Auxiliary (Interlead) Leakages: Measured Isolated Signal Inputs/Outputs: Skipped Applied Part Groups Group 1: Name: ECG Type: BF Parts: 3 AP 1 - RA AP 2 - RL/LL...
  • Page 206 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 13 (SAF13) AAMI SAFETY TEST CHASSIS LKG & GND Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Skip Insulation Resistance - Applied Parts to Ground: Skip Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 207 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 15 (SAF15) AAMI SAFETY TEST 3 LEADS (ECG) Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 208 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 16 (SAF16) AAMI SAFETY TEST 5 LEADS (ECG) Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 209 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 17 (SAF17) AAMI SAFETY TEST 10 LEADS (ECG) Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 210 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 18 (SAF18) AAMI DEFIB SAFETY 5 LD ECG & PADDLES Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 211 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 19 (SAF19) AAMI NIBP MONITOR WITH TEMP & SPO2 Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 212 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 20 (SAF20) AAMI MULTIPARAM MONITOR: ECG,BP,TEMP Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure Device Power: On...
  • Page 213 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 21 (SAF21) AAMI MULTIPARAM MONITOR W. ETHERNET Standard: AAMI ES1 Limits Used: AAMI ES1 Limits Equipment Class: Class I Line Voltage: Measure Load Current: Measure Insulation Resistance - Line 1 and 2 to Ground: Measure Insulation Resistance - Applied Parts to Ground: Measure Protective Earth: Measured At 1 Amp Leakage Current: Measure...
  • Page 214 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 22 (SAF22) AAMI BAT-POWERED ECG TELEMETRY, 5 LD Standard: AAMI-Battery Limits Used: AAMI ES1 Device Power: On Auxiliary (Interlead) Leakages: Measured Isolated Signal Inputs/Outputs: Skipped Applied Part Groups Group 1: Name: ECG Type: Isolated Parts: 5 AP 1 - RA AP 2 - RL AP 3 - LA...
  • Page 215 ES601Plus OPERATING MANUAL SAFETY AUTOSEQUENCE 24 (SAF24) IEC61010 SAFETY TEST LABORATORY EQUIPMENT Standard: IEC61010 Limits Used: IEC61010 Limits Line Voltage: Measure Load Current: Measure Insulation Resistance: Measure Insulation Resistance - Applied Parts to Ground: Skip Protective Earth: Measured At 1 Amp Leakage Current: Measure Polarity: Normal/Reverse Line 2: Normal/Open...
  • Page 216 ES601Plus OPERATING MANUAL ECG AUTOSEQUENCE 2 (ECG02) QUICK ECG TEST SEQUENCE 01 - Square Wave, 2Hz - x 1.0 02 - Triangle Wave, 2Hz - x 1.0 03 - Sine Wave, 10 Hz - x 1.0 04 - Sine Wave, 60 Hz - x 1.0 05 - ECG, 60 BPM - x 1.0 06 - ECG, 30 BPM - x 1.0 07 - ECG, 180 BPM - x 1.0...
  • Page 217 ES601Plus OPERATING MANUAL ECG AUTOSEQUENCE 4 (ECG04) SHOCK ADVISORY/AED TEST SEQUENCE 01 - Square Wave, 2Hz - x 1.0 02 - DC Pulse, 4 seconds - x 1.0 03 - Triangle Wave, 2Hz - x 1.0 04 - ECG, 60 BPM - x 1.0 05 - ECG, 30 BPM - x 1.0 06 - ECG, 120 BPM - x 1.0 07 - ECG, 240 BPM - x 1.0...

  • Page 218: Appendix B. Sample Test Record

    ES601Plus OPERATING MANUAL APPENDIX B. Sample Test Record Below is an example of a report created by the Test Report Generator of ES601pc. ES601Plus also has the capability of generating a report document similar to the one shown here, which can be output via the Printer Port or RS-232 Port as described in Chapter 5.
  • Page 219 ES601Plus OPERATING MANUAL INSULATION RESISTANCE LIMIT UNITS L1/L2 TO GND: 999.9 ---.- MEGOHMS AP TO GND: 999.9 ---.- MEGOHMS --------------- PROTECTIVE EARTH TEST --------------- LIMIT: 0.200 OHMS MULTIPLE PE TEST: NO OFFSET: -.--- OHMS LINE CORD TEST: YES CURRENT: 25A AC POINT TO POINT: NO NUMBER OF TESTS: 01 TEST TYPE--------VALUE---...
  • Page 220 ES601Plus OPERATING MANUAL *********************** PROCEDURE ********************** PROCEDURE TYPE: Test Procedure PROCEDURE No.: STEP ---------------- TASK ------------------ RESULT CAUTION: HIGH VOLTAGE ...........OK REVIEW MANUFACTURER LITERATURE AS NEEDED ...........OK TEST EQUIPMENT: DEFIBRILLATOR TESTER ...........OK TEST EQUIPMENT: PACEMAKER ANALYSER ...........OK TEST EQUIPMENT: PULSE OXIMETRY TESTER ...........OK TEST EQUIPMENT: STOP WATCH ...........OK...
  • Page 221 ES601Plus OPERATING MANUAL ...........OK SET PULSE AMPL=100% ...........OK SET ARTIFACT=OFF ...........OK CHECK SPO2=96-98%; RATE=59-61BPM SPO2=96% RATE=60BPM - OK....PASS CHECK SPO2=88-92%; RATE=59-61BPM SPO2=89% RATE=60BPM - OK....PASS CHECK SPO2=78-82%; RATE=59-61BPM SPO2=79% RATE=60BPM - OK....PASS CHECK SPO2=68-72%; RATE=59-61BPM SPO2=68% RATE=60BPM - OK....PASS SET SPO2=93% ...........OK CHECK SPO2=92-94%;...
  • Page 222 Defibrillator's built-in pulse oximeter by means of an AutoSequence designed to automatically operate the Datrend Systems Oxitest Plus 7 pulse oximeter tester. Appendix B # Page 203...
  • Page 223 ES601Plus OPERATING MANUAL Appendix B # Page 204...

  • Page 224: Appendix C. Automated Test Examples

    ES601Plus OPERATING MANUAL APPENDIX C. Automated Test Examples Below are examples of a General Inspection and a User-Defined Tester AutoSequence, which were created using the optional AutoSequence Editor of the ES601pc software package. This Appendix also includes an example of a Test Procedure, created with the optional Test Procedure Editor of ES601pc.
  • Page 225 ES601Plus OPERATING MANUAL USER-DEFINED TESTER 1 (UT101) OXITEST DEMO AUTOSEQUENCES GENERIC PULSE OX AUTOSEQUENCE Tester Port: Baud Rate: 9600 Baud Step Category Op Code Command Oxitest+7 K - OK Prompt SELECT PULSE OXIMETER ON OXITEST+ Oxitest+7 C - Tester Ctrl HR60•SET HEART RATE=60BPM Oxitest+7 C - Tester Ctrl...
  • Page 226 ES601Plus OPERATING MANUAL TEST PROCEDURE 86 DEFIBRILLATOR/MONITOR Tester Port: None Baud Rate: N / A Step Category Op Code Command K - OK Prompt CAUTION: HIGH VOLTAGE K - OK Prompt REVIEW MANUFACTURER LITERATURE Defib K - OK Prompt TEST EQUIPMENT: DEFIBRILLATOR TESTER Defib K - OK Prompt TEST EQUIPMENT: STOP WATCH...
  • Page 227 ES601Plus OPERATING MANUAL Appendix C # Page 208...

  • Page 228: Appendix D. Importing Equipment Records

    ES601Plus OPERATING MANUAL APPENDIX D. Importing Equipment Records Appendix D # Page 209...
  • Page 229 ES601Plus OPERATING MANUAL Appendix D # Page 210...
  • Page 230 ES601Plus OPERATING MANUAL Although columns may be matched later in the process, the equipment records to be imported should be in the following format: Appendix D # Page 211...
  • Page 231 ES601Plus OPERATING MANUAL The preceding is an example of a short equipment list. There can be more fields, but this will demonstrate the function. In this case, Column E is the test procedure number - This can be added or changed later. Be sure to save the file as “.CSV”. Appendix D # Page 212...
  • Page 232 ES601Plus OPERATING MANUAL If not already assigned, test procedures can be assigned now, and custom fields can be added or edited. Appendix D # Page 213...
  • Page 233 ES601Plus OPERATING MANUAL Ensure that the USB Driver for ES601Plus is installed and the unit connected to the PC as per section 8.2; then upload the data to the ES601Plus, and the equipment records and associated test procedures will be ready. Refer to manual MN-049 (6100-428) on the ES601 product CD for more details on the Equipment Record Editor.

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