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DATREND Systems vPad-ES AAMI-ES1 Operating Manual

Electrical safety analyzer
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vPad-ES
Electrical Safety Analyzer
Electrical Safety Analyzer
Electrical Safety Analyzer
Electrical Safety Analyzer
for AAMI-ES1
IEC 60601
Operating Manual
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Summary of Contents for DATREND Systems vPad-ES AAMI-ES1

  • Page 1 ™ vPad-ES Electrical Safety Analyzer Electrical Safety Analyzer Electrical Safety Analyzer Electrical Safety Analyzer for AAMI-ES1 IEC 60601 Operating Manual...
  • Page 3 ™ vPad-ES Electrical Safety Analyzer Operating Manual © 2013-2014 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 2014-Aug-21 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 the Analyzer Base Unit of vPad-ES (the "Datrend product") 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 to two (2) 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 or an Authorized Service Centre, 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 or an Authorized Service Centre for service and calibration, especially during the original warranty period.
  • Page 8 Page iv...

  • Page 9: Table Of Contents

    vPad-ES OPERATORS MANUAL Table of Contents ........BBREVIATIONS AND EFINITIONS .
  • Page 10 vPad-ES OPERATORS MANUAL 4.3 Test Navigation ..........31 4.4 Receptacle Control .

  • Page 11: Abbreviations And Definitions

    vPad-ES OPERATORS MANUAL Abbreviations and Definitions The following abbreviations, terms and acronyms are used throughout this manual: Micro-ampere μA Ampere AAMI American Association of Medical Instrumentation Applied Parts (patient leads) Software application for a mobile device Abbreviation for circuit (ie. electrical circuit in a power distribution Cct.
  • Page 12 vPad-ES OPERATORS MANUAL Protective Earth. The line (conductor) connected to a place that is maintained at “Ground” or “Earth” voltage. right arm ECG lead right leg ECG lead Root-Mean-Square measurement of a parameter (eg. V ..) Standards established by various national and international agencies. Safety Standard The most recognized Standards Organizations include: AAMI - Association for Advancement of Medical Instrumentation...

  • Page 13: Symbol Definitions

    vPad-ES OPERATORS MANUAL Symbol Definitions The following symbols may be found on vPad-ES: CONSULT MANUAL FOR PROPER OPERATION The operating manual provides valuable information on the proper use of vPad-ES. It is highly recommended the operator read the instructions thoroughly before operating the device. It is possible to damage the Equipment Under Test (EUT) and/or cause harm to the operator if vPad-ES is used incorrectly.
  • Page 14 vPad-ES OPERATORS MANUAL DO NOT EXCEED THE FOLLOWING CURRENT LOAD ON THE EUT 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.

  • Page 15: Specifications

    vPad-ES OPERATORS MANUAL Specifications Equipment Performance Specifications 1.1 Electrical Safety Testing Standards - IEC60601-1 - ANSI/AAMI-ES1 1.2 Safety Tests - Line Voltage - External (point-to-point) Voltage - External (point-to-point) Micropotential - Equipment Load Current - Equipment Power Consumption - Line Cord Resistance - External (point-to-point) Resistance - Chassis Leakage Current (IEC touch current) - Ground Leakage Current (IEC earth leakage current)

  • Page 16: Instrument Specifications

    vPad-ES OPERATORS MANUAL 1.3 Instrument Specifications 1.3.1 Voltage Measurement Line voltage Range........90 to 264 V rms Accuracy ......... ±(2 % of reading + 0.2 V) External (point-to-point) voltage Range........0 to 300 V rms Accuracy ........ ±(1 % FS + 0.2 V) External (point-to-point) micropotential Ranges........

  • Page 17: Leakage Current Measurement

    vPad-ES OPERATORS MANUAL 1.3.5 Leakage Current Measurement Modes........... AC+DC (True-rms) AC only DC only Patient Load Selection......AAMI ES1-1993 IEC 60601 Crest factor .......... <=3 Ranges..........0.0 to 199.9 µA 200 to 1,999 µA 2,000 to 19,999 µA Accuracy DC to 1 kHz......±(1 % of reading + 1 µA) 1 to 100 kHz ......

  • Page 18: Measurement Terminals

    vPad-ES OPERATORS MANUAL 1.4 Measurement Terminals 1.4.1 Test Receptacle Category..........CAT II Maximum Voltage North America....... 132 VAC Europe/Asia......264 VAC Maximum Current North America....... 20A AC Europe/Asia......13A AC Use vPad power cord 3000-009 for instruments rated to 15A Use vPad power cord 3000-010 for instruments rated to 20A 1.4.2 Current Source Terminals (SRC+/-) Category..........

  • Page 19: User Interface

    vPad-ES OPERATORS MANUAL 1.5 User Interface Display............10.1" colour LCD (1280 x 800) User Controls..........Capacitive touchscreen Wired Connectivity........Micro USB 2.0 Type B (shareable with base unit) USB 2.0 Type A (premium tablet only) XBUS Interface (RJ11-6) Wireless Connectivity........802.11 b/g/n Bluetooth 2.1+ EDR †...

  • Page 20: Electrical Ratings

    vPad-ES OPERATORS MANUAL Equipment Technical Specifications 1.6 Electrical Ratings 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 21: Standard Accessories

    vPad-ES OPERATORS MANUAL 1.11 Standard Accessories vPad Kelvin Cable......... P/N 3140-475 vPad Tablet USB Cable........ P/N 3140-478 vPad Tablet DC Cable........P/N 3140-476 (12V) or -477 (5V), depending on tablet model Power Cord (country specific) North America 15A......P/N 3000-009 North America 20A......
  • Page 22 vPad-ES OPERATORS MANUAL Specifications/Chapter 1 # Page 8...

  • Page 23: Overview

    vPad-ES OPERATORS MANUAL Overview vPad-ES™ is a manually-operated electrical safety analyzer providing basic electrical safety testing of medical devices with patient leads. This chapter provides an overview of vPad-ES features and test modes. A summary of testing requirements specified by NFPA®, AAMI and IEC safety standards is included at the end of this chapter.
  • Page 24 vPad-ES OPERATORS MANUAL Figure 1 - vPad-ES Analyzer Base Unit. Overview/Chapter 2 # Page 10...

  • Page 25: Test Receptacle Configuration

    vPad-ES OPERATORS MANUAL Item Description/Function 10. Binding posts Connect to EUT patient leads or applied parts, for example, ECG leads 11. Meter input, EXT+/- Input to voltmeter or leakage measuring device 12. Current source, SRC+/- Current source output for four-wire resistance measurement 13.

  • Page 26: User Interface

    vPad-ES OPERATORS MANUAL 2.1.3 User Interface The user interface of vPad-ES is based on an Android™-powered tablet computer. Android provides numerous features which make vPad-ES unique as a biomedical test instrument: • HD colour display with capacitive touchscreen • 4 to 16GB of internal memory (depending on tablet model), expandable via accessory SD Card •...

  • Page 27: Test Modes

    vPad-ES OPERATORS MANUAL 2.2 Test Modes vPad-ES provides a variety of test modes which are useful for performing electrical safety measurements on medical equipment. Line Voltage Use this mode to test the AC supply which powers vPad-ES. Measure voltages from AC supply hot to neutral; from hot to ground; and from neutral to ground. External Voltage Use this mode to check larger voltages between two arbitrary points, up to 300V RMS maximum.
  • Page 28 vPad-ES OPERATORS MANUAL Chassis Leakage Use this mode to check for leakage current that may flow from the chassis or enclosure of the EUT to ground of the AC supply. For Chassis and other leakage tests described below, you may choose either the AAMI or IEC measuring device (MD).

  • Page 29: Safety Test Standards

    vPad-ES OPERATORS MANUAL 2.3 Safety Test Standards vPad-ES may be used to perform electrical safety tests of medical devices with patient leads, following NFPA® 99, AAMI-ES1 and IEC60601-1 standards. TABLE 2.3-1 relates test nomenclature displayed by vPad-ES to nomenclature of the standards. TABLE 2.3-2 defines additional terms which pertain in general to electrical safety testing of medical equipment.
  • Page 30 vPad-ES OPERATORS MANUAL TABLE 2.3-2: Safety Test Terminology Term Definition Equipment Under Test Normal operating condition. AC supply to EUT has ground and neutral both normal (closed). Single-Fault Condition. AC supply to EUT has ground or neutral disconnected (open). Applied Part(s). IEC term referring to patient / ECG leads of EUT Type B IEC applied part protection class, type "Body"...
  • Page 31 vPad-ES OPERATORS MANUAL testing methods, which are summarized in TABLE 2.3-3. vPad-ES encompasses requirements of the standards by providing the necessary test settings that enable you to follow the standard of your choice. TABLE 2.3-3: Leakage Test Requirements by Standard Leakage Test NFPA 99:2012...
  • Page 32 vPad-ES OPERATORS MANUAL Leakage Test NFPA 99:2012 AAMI-ES1:1993 IEC60601-1:2007 (Ed. 3) Lead Not required • Test with EUT ON and OFF • Test with EUT ON and OFF isolation • Test normal/reverse polarity • Test normal/reverse polarity test • Test each lead individually •...
  • Page 33 vPad-ES OPERATORS MANUAL TABLE 2.3-4: Maximum Limits by Standard Test NFPA 99:2012 AAMI-ES1:1993 IEC60601-1:2007 (Ed. 3) Line cord 0.5 Ω Not specified 0.2 Ω resistance Chassis 100 μA 100 μA 100 μA leakage SFC: 500 μA SFC: 300 μA SFC: 500 μA Ground Not specified...
  • Page 34 vPad-ES OPERATORS MANUAL Overview/Chapter 2 # Page 20...

  • Page 35: Setup

    vPad-ES OPERATORS MANUAL 3 Setup After placing the Analyzer Base Unit on a stable, flat surface, pull out the tablet tray on the front of the unit. Figure 3 At the back of the Base Unit above the binding posts, grab the tablet and carefully lift it away from the unit.
  • Page 36 vPad-ES OPERATORS MANUAL Place the bottom of the tablet on the tray and rest the rear of the tablet on the front of the base unit. The tablet may also be held in place without the tray, using the inherent ‘sticky’ characteristics of the labels on the back of the tablet and the front of the base unit.
  • Page 37 vPad-ES OPERATORS MANUAL Connect the USB cable provided with vPad-ES (P/N 3140-478) from the TABLET USB jack of the Base Unit to the USB port of the tablet. Figure 9 Figure 8 Connect the power cord provided with vPad-ES to the right side panel of the unit, then plug the cord into a Figure 10 power outlet ( ).
  • Page 38 vPad-ES OPERATORS MANUAL With the Base Unit now powered up, switch the tablet ON by pressing and holding the power button on the top of the tablet until the tablet is felt to vibrate (approx. 5 - 10 sec). Approximately 60 seconds after switching ON, the Android HOME screen should appear on the tablet.
  • Page 39 vPad-ES OPERATORS MANUAL Switch the tablet OFF when vPad-ES is not in use. Press and hold the ON/OFF switch until a confirmation message appears on the tablet screen. Select the appropriate response to complete the Power Off sequence. Note: Pressing and releasing the Power ON/OFF button momentarily will put the tablet in a ‘sleep’ mode. Press the ON/OFF button momentarily again to ‘wake’...
  • Page 40 vPad-ES OPERATORS MANUAL Setup/Chapter 3 # Page 26...

  • Page 41: Operation

    vPad-ES OPERATORS MANUAL 4 Operation This chapter explains how to use vPad-ES to perform electrical safety tests and inspections of medical equipment. Test Record management is also covered in this chapter. 4.1 HOME Screen Figure 14 The Android HOME screen ( ) is displayed approximately 60 seconds after switching the tablet Figure 14 - HOME screen.
  • Page 42 vPad-ES OPERATORS MANUAL Initiate actions on the tablet by pressing the corresponding icon or button. For example: Press to launch the vPad-ES software application, or " ". Use this app to perform electrical safety testing. Press to launch the vPad Record Manager app. Use this app to copy, print, convert or delete Test Records saved by vPad-ES.

  • Page 43: Startup

    vPad-ES OPERATORS MANUAL 4.2 Startup Press the vPad-ES icon on the Android Home screen to start the app. A splash screen will display the product name and the software version. Figure 15 - vPad-ES startup screen. As the splash screen is displayed, the app will "connect" to the Analyzer Base Unit and cause it to perform a number of internal self-tests.
  • Page 44 vPad-ES OPERATORS MANUAL Alarm Message Cause Actions ERROR: App is unable to send • Check Base Unit has power cannot communicate with messages to one or more (check power indicator, left panel - see Figure 1 on Base Unit instrument systems inside page 10) the Base Unit •...

  • Page 45: Test Navigation

    vPad-ES OPERATORS MANUAL 4.3 Test Navigation After startup, the main menu of vPad-ES is displayed. Tabs at the top of the screen navigate between the test modes provided by vPad-ES. By default, vPad-ES selects the Voltage tab after startup. To select a different test mode, press the corresponding tab.
  • Page 46 vPad-ES OPERATORS MANUAL stop Android navigation buttons override the app display but do not necessarily what an app may be doing. If the test receptacle is , and you navigate away from vPad-ES by pressing: Home , or Recent the test receptacle will remain .

  • Page 47: Voltage Tests

    vPad-ES OPERATORS MANUAL 4.5 Voltage Tests Following application startup, vPad-ES defaults to measurement of the AC supply or "line voltage", from Line 1 (L1) to Line (L2). Figure 19 - Voltage test mode. This test mode enables measurement of three different voltages associated with the AC supply, and two external or point-to-point voltages.

  • Page 48: Line Voltage

    vPad-ES OPERATORS MANUAL 4.5.1 Line Voltage Figure 20 Figure 22 Press the corresponding Line Voltage button to measure the desired potential per No external test leads are necessary. Voltages are measured over a range of 90-264 VAC. With respect to the illustrations, note the following: Line 1 (L1) = AC supply Hot (H) Line 2 (L2)

  • Page 49: External Voltage

    vPad-ES OPERATORS MANUAL 4.5.2 External Voltage Press the External Voltage button to measure large voltages between two arbitrary points, typically 20V, up to a maximum of 300V. Connect test leads to the voltmeter at EXT+ and EXT- jacks on the left panel of the Analyzer Base Unit. You may use standard multimeter (DMM) probes, or alternatively two vPad Kelvin Cables, as respectively Figure 23 Figure 24...

  • Page 50: External Micropotential

    vPad-ES OPERATORS MANUAL 4.5.3 External Micropotential Press the External mV button to measure small potentials in the millivolt range between two arbitrary points, up to a maximum of 20V. When you select this test, an Alert Dialog is displayed to remind you of vPad-ES maximum ratings. Press "OK"...
  • Page 51 vPad-ES OPERATORS MANUAL Connect test leads to the voltmeter at EXT+ and EXT- jacks on the left panel of the Analyzer Base Unit. You may connect to external points using two standard multimeter (DMM) probes, or two vPad Kelvin Figure 26 Cables as shown in .

  • Page 52: Equipment Load Tests

    vPad-ES OPERATORS MANUAL 4.6 Equipment Load Tests Select Equipment Load test mode by pressing the corresponding tab at the top of the screen. When this mode is selected, the test receptacle is switched automatically. Refer to Section 4.4 for important information and instructions concerning operation of the test receptacle.

  • Page 53: Load Current

    vPad-ES OPERATORS MANUAL 4.6.1 Load Current Connect the EUT to the test receptacle and press the Load Current button to place an AC ammeter in Figure 29 series with the EUT ( ). No external test leads are necessary. AC current is measured up to 2A or 20A, with the range being automatically selected by vPad-ES as required.

  • Page 54: Resistance Tests

    vPad-ES OPERATORS MANUAL 4.7 Resistance Tests Select Resistance test mode by pressing the corresponding tab at the top of the screen. Figure 31 - Resistance test mode. This mode enables measurement of resistance of the line cord which conveys AC power to the equipment under test (EUT).

  • Page 55: Line Cord Resistance

    vPad-ES OPERATORS MANUAL 4.7.1 Line Cord Resistance Press the Line Cord Resistance button to measure the resistance from the EUT chassis to the ground pin on the plug of the EUT's line cord. This test is the default on entry to the Resistance mode. An Alert Dialog is displayed if the test receptacle is when this test is selected.

  • Page 56: External Resistance

    vPad-ES OPERATORS MANUAL Resistance is measured up to 2 Ω. If vPad-ES indicates X.XX, the resistance exceeds 2 Ω and may be open- circuit. When the display shows X.XX, a poor connection to the EUT chassis may be the problem; inspect attachment of the Kelvin Cable or move the cable to a different point on the chassis.

  • Page 57: Measurement Method

    vPad-ES OPERATORS MANUAL 4.7.3 Measurement Method Figure 33 Figure 34 Referring to , vPad-ES uses a "four-wire method" when measuring line cord or point-to-point resistance. Not apparent from the schematics are two separate insulated conductors in the Kelvin Cable, one conductor conveying a current (I) to the resistance under test (R), and the other conductor conveying voltage (V) caused by current (I) to a voltmeter.

  • Page 58: Leakage Tests

    vPad-ES OPERATORS MANUAL 4.8 Leakage Tests Select the Leakage test mode by pressing the corresponding tab at the top of the screen. The test receptacle will be switched automatically, in normal condition. Refer to Section 4.4 for important information and instructions concerning operation of the test receptacle.

  • Page 59: Ground (Earth)

    vPad-ES OPERATORS MANUAL The Leakage test mode enables measurement of Chassis and Ground Leakage currents (or, in IEC terminology, Touch Current and Earth Leakage respectively). External or point-to-point leakage may also be tested. As selected by the upper row of buttons, the type of leakage current under test is indicated immediately above the numeric readout.

  • Page 60: Chassis Leakage

    vPad-ES OPERATORS MANUAL 4.8.1 Chassis Leakage Press the Chassis Leakage button to measure leakage current from the chassis or enclosure of the EUT to the ground of the AC supply. Chassis Leakage is the default upon selection of the Leakage test mode. Connect the EUT to the test receptacle, and use the vPad Kelvin Cable to connect a conductive point on Figure 37 the EUT chassis to the EXT+ jack on the left side of the Base Unit, as shown in...

  • Page 61: Ground Leakage

    vPad-ES OPERATORS MANUAL When Polarity is changed, the test receptacle is switched OFF for a period of time, after which the Figure 38 receptacle is then re-activated at the new polarity (see ). During the delay, receptacle controls are disabled. This time delay is necessary to prevent surges in supply current which could potentially damage the EUT and/or vPad-ES.

  • Page 62: External Leakage

    vPad-ES OPERATORS MANUAL Figure 40 - Ground leakage test. The Ground control is disabled for this test. Per AAMI and IEC test requirements, Neutral of the test receptacle may be set to "Open" as a single-fault condition. Note ground (earth) leakage testing is not applicable to IEC Class II medical equipment, since the EUT has no ground conductor to convey the current.
  • Page 63 vPad-ES OPERATORS MANUAL Connect test leads to the leakage measuring device at EXT+ and EXT- jacks on the left panel of the Figure 42 Analyzer Base Unit. You may connect to external points using two vPad Kelvin Cables ( ), or with Figure 43 standard multimeter probes ( ).

  • Page 64: Test Application

    vPad-ES OPERATORS MANUAL Figure 44 - External leakage test with one Kelvin cable. 4.8.4 Test Application At a minimum, chassis leakage of medical equipment should be tested with the AC supply in normal polarity and with the ground open, with equipment power switch set to ON position and then to OFF position.

  • Page 65: Patient Lead Tests

    vPad-ES OPERATORS MANUAL 4.9 Patient Lead Tests Select the Patient Lead test mode by pressing the corresponding tab at the top of the screen. When this mode is selected, the test receptacle is switched automatically, in normal condition. Refer to Section 4.4 for important information and instructions concerning operation of the test receptacle.

  • Page 66: Lead-To-Ground Leakage

    vPad-ES OPERATORS MANUAL Refer to Section 4.8.1 for instructions on operation of the Ground, Neutral and Polarity test receptacle controls. Sections 4.9.1 to 4.9.3 provide instructions for the Patient Lead test mode. 4.9.1 Lead-to-Ground Leakage Press the Lead-to-GND Leakage button to measure leakage current from a selected ECG lead or patient- applied part (AP) to ground of the AC supply.

  • Page 67: Lead-To-Lead Leakage

    vPad-ES OPERATORS MANUAL Figure 47 - Operation of binding post. Referring to Figure 45 , select patient leads individually or in groups by pressing the corresponding radio Figure 46 button under the numeric readout. This closes the corresponding switch or switches S to S connecting the measuring device (MD) to the lead(s).
  • Page 68 vPad-ES OPERATORS MANUAL Figure 48 - Lead-to-lead leakage display. Figure 49 - Lead-to-lead leakage test. Lead-to-lead (auxiliary) leakage may be tested for IEC Class I and Class II medical equipment. No special provisions are required when testing Class II, however, note the Ground control of the safety analyzer will have no influence on the test result since the EUT lacks a ground conductor in the line cord.

  • Page 69: Lead Isolation Test

    vPad-ES OPERATORS MANUAL 4.9.3 Lead Isolation Test Press the Isolation Test button to measure leakage current which is caused by connecting a selected ECG lead or patient-applied part (AP) to an isolated, current-limited source of voltage equal to the AC supply. For compliance with IEC test requirements, this test mode also permits selection of functional groups of applied parts in various combinations.
  • Page 70 vPad-ES OPERATORS MANUAL To prepare for the test, connect the power cord of the EUT to the test receptacle, and connect the EUT Figure 51 patient leads to the corresponding binding posts of vPad-ES as shown in . If the EUT is Class II (two-wire power cord), use a jumper lead to connect the green "AUX"...

  • Page 71: Test Application

    vPad-ES OPERATORS MANUAL Figure 52 - Lead isolation test (isolation voltage ON). While the test voltage is either OFF or ON, individual patient leads or lead groups may be selected by pressing the corresponding radio button under the numeric readout. Selecting a particular lead or group of Figure 51 leads closes the corresponding switch or switches S to S...
  • Page 72 vPad-ES OPERATORS MANUAL To summarize testing requirements for AAMI-ES1, leakage to ground is measured for each EUT lead individually as well as for all leads shorted together as a group. Isolation tests are performed on individual leads only. Under this standard, tests do not depend on the medical function of the leads. A greater number of test requirements are specified under the IEC 60601 standard.

  • Page 73: Leakage Settings

    vPad-ES OPERATORS MANUAL 4.10 Leakage Settings Figure 35 Figure 45 Press the Settings button of the Leakage test mode ( ) or the Patient Lead test mode ( Figure 53 to enter the Leakage Settings menu, shown in Figure 53 - Leakage settings menu.
  • Page 74 vPad-ES OPERATORS MANUAL To view or change a setting other than Auto-OFF, press the corresponding row on the menu (Standard; AC/DC Filter; or Polarity Delay). Figure 54 The Standard setting ( ) allows you to choose the type of leakage measuring device (MD) based on the Standard to be used.
  • Page 75 vPad-ES OPERATORS MANUAL Press the radio button to enable the corresponding filter, or Cancel to exit without changing the setting. Figure 55 - Set measuring device filter. When the test receptacle polarity is changed during a test, the receptacle is switched OFF for a period of time, after which the receptacle is then re-activated at the new polarity.
  • Page 76 vPad-ES OPERATORS MANUAL Figure 56 - Set polarity switching delay. Operation/Chapter 4 # Page 62...

  • Page 77: Ecg Simulator

    vPad-ES OPERATORS MANUAL 4.11 ECG Simulator Select ECG Simulator mode by pressing the corresponding tab at the top of the screen. vPad-ES will default to outputting a 2 Hz square wave to the ECG binding posts. Figure 57 - ECG simulator mode. Test signals and physiological simulations are organized in five general categories such as Performance Waves or Sinus Rhythm.
  • Page 78 vPad-ES OPERATORS MANUAL TABLE 4.11-1 describes the waveforms which may be selected via the menu. Amplitudes are specified for ECG Lead II connection at the patient monitor. TABLE 4.11-1: ECG Simulator Waveforms Simulator Menu Simulator Waveform Description vPad-ES Name Performance Square wave, 2 Hz, 1 mV p-p (-0.5 to +0.5 mV) SQR 2Hz Performance...

  • Page 79: Ecg Test

    vPad-ES OPERATORS MANUAL Simulator Menu Simulator Waveform Description vPad-ES Name Arrhythmia Arrhythmia, ventricular fibrillation, coarse VFIB Arrhythmia Arrhythmia, atrial fibrillation, coarse AFIB Arrhythmia Arrhythmia, supraventricular tachycardia at 200BPM Arrhythmia Arrhythmia, monomorphic ventricular tachycardia VTACH at 190 BPM Arrhythmia Arrhythmia, unifocal preventricular contraction following 5 normal ECG beats Arrhythmia Arrhythmia, asystole, random baseline...

  • Page 80: Common-Mode Test

    vPad-ES OPERATORS MANUAL 4.11.2 Common-Mode Test When a Common-Mode Rejection Ratio (CMRR) test is selected, the ECG simulator is internally Figure 59 configured as shown in . Limb and chest leads are connected together and driven with a common 10 mV signal with respect to RL. Figure 59 - Common-mode rejection test.

  • Page 81: Equipment Inspection

    vPad-ES OPERATORS MANUAL 4.12 Equipment Inspection 4.12.1 Inspection Tasks Voltage, Load Current, Resistance and ECG Simulator test modes provide an Equipment Inspection button. Pressing this button displays a dialog for performing and recording an inspection. Figure 60 - Equipment Inspection dialog. The Equipment Inspection is based on a list of checkpoints or tasks, which are explained in the General Devices Acceptance Procedure (no.
  • Page 82 vPad-ES OPERATORS MANUAL Figure 60 The Next Task button on the dialog of increments the displayed "Task" through a list of items to be inspected or serviced, following the ECRI procedure as summarized in TABLE 4.12-1. TABLE 4.12-1: Equipment Inspection Tasks Inspection Activity Task (perform as applicable)
  • Page 83 vPad-ES OPERATORS MANUAL Inspection Activity Task (perform as applicable) Summary Motor/pump/fan Check shaft alignment; check wear; lubricate as required. Fluid levels Check and fill as required. Battery/charger Replace battery if necessary or per schedule; check rechargeable battery can hold sufficient charge; check battery charger function. Indicators/displays During inspection activities, check operation of all lights, indicators, meters, gauges, waveform displays and numeric display segments.

  • Page 84: Performing An Inspection

    vPad-ES OPERATORS MANUAL 4.12.2 Performing an Inspection Figure 60 To use the Equipment Inspection dialog of Select the task to be performed, using the Next / Previous Task buttons. Per the ECRI document, tasks can be performed in any order; some tasks may not be applicable to the equipment and would therefore be skipped.
  • Page 85 vPad-ES OPERATORS MANUAL Figure 61 - Inspection comment entry. Other inspection items may be selected via Next / Previous Task buttons while the Android keyboard is being displayed. Alternatively, once a comment has been input the keyboard can be dismissed, by pressing the ENTER button , or alternatively the "dismiss keyboard"...

  • Page 86: Data Recording

    vPad-ES OPERATORS MANUAL 4.13 Data Recording Each test mode of vPad-ES provides means for recording and viewing measurement data during the course of a test. Once sufficient data has been collected and information about the equipment under test (EUT) has been entered, results may then be saved as a file in a designated folder on the "internal SD card" (internal non-volatile memory) of the Android tablet.
  • Page 87 vPad-ES OPERATORS MANUAL Android text fields may be either single- or multi-line. A practically unlimited amount of text may be typed for either single- or multi-line fields. Pressing ENTER for a single-line text field causes data entry to jump to the next text field on the screen.

  • Page 88: Recording Measurements And Notes

    vPad-ES OPERATORS MANUAL As an alternative to typing with the keyboard, voice recognition may be used (requires an Internet connection). To enable, press . Android voice recognition technology has good performance, particularly when entering numbers. When done entering text, the Android keyboard may be removed from the screen by pressing bottom left.
  • Page 89 vPad-ES OPERATORS MANUAL Figure 66 - Enter additional notes or comments. By default, notes are inserted into the test data before the measurement value. Alternatively, to place notations after the measurement value, press the Insert note... After radio button (see Figure 65 To save notations only, without any measurement data, uncheck the Save this checkbox near the top of Figure 65...

  • Page 90: Viewing Measurements And Notes

    vPad-ES OPERATORS MANUAL 4.13.3 Viewing Measurements and Notes Via the Save Data menu of Section 4.13.2, measurements and notes may be saved to a holding buffer while testing is in progress. To view contents of this buffer, press the View Data button. If the amount of data exceeds the length of the window, scroll it into view by means of a press-and-drag gesture in the window.

  • Page 91: Recording Equipment Information

    vPad-ES OPERATORS MANUAL 4.13.4 Recording Equipment Information Press Enter Equipment Info on the Save Data or View Data menu to pop-up the equipment information editor. Figure 68 - Equipment information editor. Tap on a text field to display the Android keyboard and enter information. If an external keyboard or barcode scanner is connected to the tablet, the Android keyboard is not displayed and data entry is then accepted from the external input device.
  • Page 92 vPad-ES OPERATORS MANUAL Pressing ENTER on the keyboard advances data input to the next text field on the screen. Alternatively, use to navigate the text fields, or simply tap a field to jump immediately there. At a minimum an equipment control number, or other ID, must be entered in the Control Number field in order to save a Test Record.

  • Page 93: Creating A Test Record

    vPad-ES OPERATORS MANUAL 4.13.5 Creating a Test Record Press the Create Record button on the View Data menu to save recorded measurement values, notes, equipment information and inspection results as a Test Record file. You must save at least one measurement and an equipment control number/ID before the View Data menu will permit you to create a Test Record (see Sections 4.13.2 through 4.13.4 respectively).
  • Page 94 vPad-ES OPERATORS MANUAL Figure 71 The filename and path of the Test Record are shown at the top of the Create Record menu ( The filename is derived automatically by vPad-ES, in the following format: <control_number>_<date_code>_<timestamp>_<result>.txt where: is the Control Number field from the Equipment Information menu (see control_number Section 4.13.4).
  • Page 95 vPad-ES OPERATORS MANUAL Optionally, time spent working on the EUT may be entered after tapping on the Technican labor time field. This causes the Android numeric keypad to be displayed. Enter the labor time in hours. Figure 72 - Optionally, enter technician labor time (hours). Test Record files include a Title at the beginning of the file.
  • Page 96 vPad-ES OPERATORS MANUAL Optionally, concluding comments about the EUT or test results may be entered after tapping the Final comments field. Information entered in this text field will appear at the end of the Test Record file. Any number of lines may be entered into the text field. Figure 74 - Optionally, enter final comments about EUT or test.

  • Page 97: Record Manager App

    vPad-ES OPERATORS MANUAL 4.14 Record Manager App vPad Record Manager is an app which is installed on the Android tablet and which may be run independently of, or simultaneously with, the vPad-ES app. Record Manager may be used to copy, print, and/or delete Test Record files saved by vPad-ES. Record Manager can also be used to convert Test Records to Adobe PDF documents.
  • Page 98 vPad-ES OPERATORS MANUAL Operation/Chapter 4 # Page 84...

  • Page 99: 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. Unit 130 - 4020 Viking Way Richmond, BC • CANADA • V6V 2L4 Tel 604.291.7747 or 800.667.6557 •...
  • Page 100 vPad-ES OPERATORS MANUAL Maintenance/Chapter 5 # Page 86...

  • Page 101: Appendix A. Sample Test Record

    vPad-ES OPERATORS MANUAL APPENDIX A. Sample Test Record This appendix provides an example of a vPad-ES Test Record, illustrating the data representation for voltage, current, resistance and leakage measurements, as well as ECG waveform data. Inspection data and example notes have been recorded for some measurements to show how these typically appear in a record. This is an example of a "maximum"...
  • Page 102 vPad-ES OPERATORS MANUAL Line cord insulation was split. Replaced the cord. Strain reliefs: PASS Circuit breaker/fuses: PASS Wrong fuse was installed. Replaced with correct fuse. Tubes and hoses: PASS Cables: PASS Fittings/connectors: PASS Electrodes/transducers: PASS Filters: PASS Controls and switches: PASS Heater: PASS...
  • Page 103 vPad-ES OPERATORS MANUAL Chassis Leakage (POL-N;NEU-O;GND-N): 12.6 μA Chassis Leakage (POL-R;NEU-N;GND-N): 3.8 μA Chassis Leakage (POL-R;NEU-N;GND-O): 189.1 μA Chassis Leakage (POL-R;NEU-O;GND-N): 15.1 μA Ground Leakage (POL-N;NEU-N;GND-O): 186.7 μA Ground Leakage (POL-N;NEU-O;GND-O): 197.8 μA Ground Leakage (POL-R;NEU-N;GND-O): 189.1 μA Ground Leakage (POL-R;NEU-O;GND-O): 200.4 μA Extrnal Leakage (POL-N;NEU-N;GND-N): 2.8 μA...
  • Page 104 vPad-ES OPERATORS MANUAL Lead-GND ALL (POL-R;NEU-N;GND-O): 3.6 μA Lead-GND LA/AP1 (POL-R;NEU-O;GND-N): 2.0 μA Lead-GND RA/AP2 (POL-R;NEU-O;GND-N): 2.1 μA Lead-GND LL/AP3 (POL-R;NEU-O;GND-N): 2.0 μA Lead-GND RL/AP4 (POL-R;NEU-O;GND-N): 2.0 μA Lead-GND V1-V6 (POL-R;NEU-O;GND-N): 2.0 μA Lead-GND AP1-3 (POL-R;NEU-O;GND-N): 3.5 μA Lead-GND AP1-4 (POL-R;NEU-O;GND-N): 3.6 μA Lead-GND AP4-10 (POL-R;NEU-O;GND-N):...
  • Page 105 vPad-ES OPERATORS MANUAL Test the patient monitor response with some ECG simulations... ECG Test: SQR 2Hz ECG Test: TRI 2Hz ECG Test: PUL 4sec ECG Test: PUL 30ppm ECG Test: PUL 60ppm ECG Test: SQR 1KHz ECG Test: SIN 0.5Hz ECG Test: SIN 10Hz ECG Test: SIN 40Hz ECG Test: SIN 50Hz...

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