vpad-mini Electrical Safety Analyzer Operating Manual

vpad-mini Electrical Safety Analyzer Operating Manual

vpad-mini Electrical Safety Analyzer Operating Manual 2018 Datrend Systems Inc. Unit 130-4020 Viking Way Richmond, BC CANADA V6V 2L4 Tel: 800.667.6557 (North America Only) or +1.604.291.7747 Fax +1.604.294.2355 e-mail: customerservice@datrend.com

To order this manual, use Part Number 6100-134 Revision Revision History Description Date A Initial release 2018-Feb-22 Copyright Datrend Systems Inc. ( DSI ) agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Datrend Systems Inc. Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking the instrument. Notify the freight carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches. Claims Our routine method of shipment is via common carrier. Upon delivery, if physical damage is found, retain all packing materials in their original condition and contact the carrier immediately to file a claim. If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any other problems not caused by shipping damage, please contact your local sales representative or DSI immediately. Standard Terms and Conditions Refunds & Credits Please note only serialized products (products labelled with a distinct serial number) and accessories are eligible for partial refund and/or credit. Non-serialized parts and accessory items (cables, carrying cases, auxiliary modules, etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been damaged, and must be returned complete (meaning all manuals, cables, accessories, etc.) within 90 days of original purchase and in as new and resalable condition. The Return Procedure must be followed. Return Procedure Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from Datrend Customer Service. All items being returned must be sent prepaid (freight, duty, brokerage, and taxes ) to our factory location. Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15%. Products returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20%. Additional charges for damage and/or missing parts and accessories will be applied to all returns. Products which are not in as new and resalable condition, are not eligible for credit return and will be returned to the customer at their expense. Certification This instrument was thoroughly tested and inspected and found to meet DSI s manufacturing specifications when it was shipped from the factory. Calibration measurements are traceable to the National Research Council of Canada (NRC) and/or the National Institute of Standards and Technology (NIST). Devices for which there are no NRC/NIST calibration standards are measured against in-house performance standards using accepted test procedures. Page i

Warranty Warranty and Product Support Datrend Systems Inc. ("DSI") warrants the Analyzer Base Unit of vpad-mini (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*. During the warranty period DSI will, at our option, either repair or replace defects in materials and workmanship at no charge; provided the Datrend product is returned (shipping, duty, brokerage and taxes prepaid) to DSI. Any and all transportation charges incurred are the responsibility of the purchaser and are not included within this warranty. This warranty extends only to the original purchaser and does not cover damage from abuse, neglect, accident or misuse or as the result of service or modification by other than DSI. IN NO EVENT SHALL DATREND SYSTEMS INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES. This warranty is subject to the following limitations:! Tablet PC: per tablet manufacturer's original warranty! Standard Accessories: 90 day limited warranty! Damage due to activation of devices under test which are connected to the applied parts inputs is not covered under the warranty! Re-calibration of the instrument, which has a recommended annual calibration frequency, is not covered under the warranty. No warranty shall apply when damage is caused by any of the following:! Power failure, surges, or spikes,! Damage in transit or when moving the instrument,! Improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,! Accident, alteration, abuse or misuse of the instrument,! Fire, water damage, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc. Only serialized products (those items bearing a distinct serial number tag) and their accessory items are covered under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED UNDER THE WARRANTY. Items such as cables and non-serialized modules are not covered under this warranty. This warranty gives you specific legal rights and you may have other rights, which vary from province to province, state to state, or country to country. This warranty is limited to repairing the instrument to DSI's specifications. When you return an instrument to DSI for service, repair or calibration, we recommend shipment using the original shipping foam and container. If the original packing materials are not available, we recommend the following guide for repackaging:! Use a double-walled carton of sufficient strength for the weight being shipped.! Use heavy paper or cardboard to protect all instrument surfaces. Use non-abrasive material around all projecting parts.! Use at least four inches of tightly packed, industrial-approved, shock-absorbent material all around the instrument. DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and taxes). No returns will be accepted without a Return Materials Authorization ("RMA ) number. Please contact Datrend (refer to Chapter 5 of this manual) to obtain an RMA number and receive help with shipping/customs documentation. * Subject to some exclusions, based on sales territory. Contact Datrend for details. Page ii

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. In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as this seal is the key to your original instrument warranty. In the event that the seal must be broken to gain internal access to the instrument (e.g., in the case of a customer-installed firmware upgrade), you must first contact Datrend Systems at 1-604-291-7747. You will be required to provide us with the serial number for your instrument as well as a valid reason for breaking the Quality Seal. You should break this seal only after you have received factory authorization. Do not break the Quality Seal before you have contacted us! Following these steps will help ensure that you will retain the original warranty on your instrument without interruption. WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Datrend Systems will not be responsible for any injuries sustained due to unauthorized equipment modifications. DSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION. THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS. UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES. Note: Calibration of Datrend products typically involves adjustment of parameters stored in firmware by proprietary software. Parties other than Datrend and its Authorized Service Centers are limited to verification of the status of the accuracy of the instrument. Do not confuse verification with calibration. vpad and vpad-mini are trademarks of Datrend Systems Inc. Android is trademark of Google Inc. Page iii

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Table of Contents ABBREVIATIONS AND DEFINITIONS.................................... VII SYMBOL DEFINITIONS............................................. IX 1 SPECIFICATIONS................................................ 1 1.1 Electrical Safety Testing Standards.................................. 1 1.2 Safety Tests.................................................... 1 1.3 Instrument Specifications.......................................... 2 1.3.1 Voltage Measurement....................................... 2 1.3.2 Load Current Measurement................................... 2 1.3.3 Resistance Measurement..................................... 2 1.3.4 Leakage Current Measurement................................ 2 1.4 Measurement Terminals.......................................... 3 1.4.1 Test Receptacle............................................ 3 1.4.2 Current Source Terminals (SRC+/-)............................. 3 1.4.3 Meter Input Terminals (EXT+/-)................................. 3 1.4.4 AP Terminal............................................... 3 1.5 User Interface.................................................. 4 1.6 Electrical Ratings................................................ 5 1.7 Externally-Accessible Fuses....................................... 5 1.8 Environment for Use............................................. 5 1.9 Dimensions.................................................... 5 1.10 Weight....................................................... 5 1.11 Standard Accessories........................................... 6 1.12 Optional Accessories............................................ 6 1.13 Compliance With Standards...................................... 6 2 OVERVIEW.................................................... 7 2.1 Analyzer Base Unit.............................................. 7 2.2 Test Receptacle Configuration...................................... 8 3 SETUP....................................................... 9 4 OPERATION.................................................. 11 4.1 Main Menu.................................................... 11 4.2 On-Line Help.................................................. 12 4.3 Settings...................................................... 12 4.4 Voltage Tests.................................................. 13 4.4.1 Terminology.............................................. 14 4.4.2 Supply Measurements...................................... 14 4.4.3 Normal Supply............................................ 14 4.4.4 Reversed Polarity.......................................... 14 Table of Contents # Page v

4.4.5 Open Ground/Isolated Mains................................. 14 4.4.6 Point-to-Point Voltages...................................... 15 4.4.7 Mains Voltages By Region................................... 15 4.5 Load Current Test.............................................. 16 4.6 Resistance Tests............................................... 17 4.6.1 PE or Ground Resistance.................................... 18 4.6.2 Point-to-Point Resistance.................................... 19 4.6.3 Limits................................................... 20 4.6.4 Method.................................................. 21 4.7 Leakage Current Tests.......................................... 22 4.7.1 Test Connections.......................................... 23 4.7.2 Abbreviations and Terminology................................ 26 4.7.3 Leakage Test Descriptions................................... 27 4.7.4 AAMI-ES1 Limits........................................... 29 4.7.5 NFPA 99 Limits............................................ 29 4.7.6 IEC 60601 Limits........................................... 29 4.7.7 IEC 62353 Limits........................................... 30 4.7.8 IEC 61010 Limits........................................... 30 4.7.9 Accessible Voltages........................................ 30 5 CALIBRATION AND MAINTENANCE.................................. 31 Table of Contents # Page vi

Abbreviations and Definitions The following abbreviations, terms and acronyms are used throughout this manual: :A Micro-ampere A AAMI AP App Cct. Earth EUT GND or Ground Hz IEC khz L1 or Line 1 L2 or Line 2 MAINS M.A.P. / MAP Measurement Category I Terminal Measurement Category II Terminal MHz NC PE Ampere 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 system) See GND Equipment Under Test. The electrical device being tested. The line (conductor) connected to a place that is maintained at Ground or Earth voltage. Same as Protective Earth. Hertz International Electrotechnical Commission Kilohertz Line 1 of the AC supply voltage, or "mains". In North America, the Hot or Live line (conductor) of the AC supply. Line 2 of the AC supply voltage, or "mains". In North America, the Neutral line (conductor) of the AC supply. The voltage provided by the building installation, nominally 120 VAC or 230 VAC depending on the country Mains on applied part(s) Intended for measurements on circuits with no direct connection to MAINS (CAT I) Intended for measurements on circuits which may have a direct connection to MAINS (CAT II) Megahertz Normal Condition of AC supply to EUT: ground and neutral are both connected Protective Earth. The line (conductor) connected to a place that is maintained at Ground or Earth voltage. Definitions # Page vii

RCD Residual current device. A device that shuts off an electric power circuit when it detects a current flowing along an unintended path. Also known as a Ground Fault Circuit Interrupter (GFCI). RMS Root-Mean-Square measurement of a parameter (eg. V rms, A rms...) Safety Standard SFC Type B (Body) Type BF (Body Floating) Type CF (Cardiac Floating) V Vrms Standards established by various national and international agencies. The most recognized Standards Organizations include: AAMI - Association for Advancement of Medical Instrumentation IEC - International Electrotechnical Commission Single-fault condition of AC supply to EUT: either ground or neutral is disconnected, but not both IEC protection class referring to patient-applied parts (leads) which are not isolated from ground IEC protection class referring to patient-applied parts (leads) which are isolated from ground IEC protection class referring to patient-applied parts (leads) which are isolated from ground and also intended for direct cardiac application Volt Volts rms Definitions # Page viii

Symbol Definitions The following symbols may be found on vpad-mini: CONSULT MANUAL FOR PROPER OPERATION The operating manual provides valuable information on the proper use of vpad-mini. 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-mini is used incorrectly. MAXIMUM RATED INPUT CURRENT: 20AMPS @ 100-120 VAC, 60 Hz when used with power cord 3000-010 15AMPS @ 100-120 VAC, 60 Hz when used with power cord 3000-009 The maximum rated input current is dependent on the power cord used. When using standard 15A electrical circuits, use the 3000-009 power cord. If current between 15 and 20A is required, find an appropriate power receptacle rated to 20A and use power cord 3000-010. AP This warning appears on the label for the applied part (AP) banana jack, located near top right on the vpad-mini faceplate. During testing of the isolation of the EUT applied parts or patient leads, a voltage equal to 100% of the AC line voltage may be present on this (CAT I) connector. This voltage may reach a maximum of ~264 VAC and, while current limited, represents a serious shock hazard to the operator. Proper precautions should be taken when performing a test which includes the application of this voltage to the EUT patient leads. The display of vpad-mini will indicate when a hazardous voltage is present at the AP jack. CAUTION: Electrical Shock Hazard, Refer Servicing to Qualified Personnel CAUTION: Consult Accompanying Documents These warnings appear on the faceplate of vpad-mini. vpad-mini contains hazardous electrical voltages internally which WILL BE present when the covers are removed. The operator should read the Operating Manual to determine what actions to take in the event of failure of vpad-mini. Refer to the Troubleshooting and Maintenance Section of the Operating Manual. Kelvin Cables (K1) The Kelvin Cable (CAT I) is used to measure the Line Cord Grounding Resistance, using a pulsed 1 amp current (200 ma RMS). The voltage present at these terminals is below 6 volts. Consult the Operating Manual for the proper operation of the Grounding Resistance test. Definitions # Page ix

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. For instance, in a circuit with a 15A circuit breaker (or fuse), the maximum current allowed to be drawn from any individual receptacle is 12A. Allowing 1A for the vpad-mini circuitry, the load current for the Equipment Under Test (EUT) should not exceed 11A. These limits are set by the Electrical Code in most jurisdictions in an attempt to avoid unexpected circuit overloads and subsequent circuit failure. If the EUT load is expected to approach the maximum value on a routine basis, it is recommended that a circuit with only a single receptacle be provided for use with vpad-mini. WARNING: OPENING THE vpad-mini MAY COMPROMISE USER SAFETY. REFER SERVICING TO DATREND AUTHORIZED AGENT. vpad-mini is a complex instrument which contains internally distributed line voltages and other high voltages for specific measurement purposes. Failure to observe appropriate measures when the instrument has been opened, or failure to reassemble correctly may compromise the safety of the user. WARNING: GROUNDING CIRCUIT CONTINUITY IS VITAL FOR SAFE OPERATION. NEVER OPERATE THE vpad-mini WITH GROUNDING CONDUCTOR DISCONNECTED. Proper grounding is essential to ensure operator safety. Do not bypass the grounding provisions inherent in the design of vpad-mini, otherwise, the operator may be subjected to an electrical shock risk. WARNING: HAZARDOUS VOLTAGES OR CONDITIONS MAY EXIST DURING TESTS. CONSULT THE ACCOMPANYING DOCUMENTS FOR APPROPRIATE PRECAUTIONS. During the execution of an electrical safety test on the EUT, vpad-mini may apply a high voltage (up to 264 VAC) to the EUT. While this voltage is current limited, it does represent a shock hazard to the operator if precautions are not followed. Consult the instructions in this manual regarding Isolation Leakage Current tests (MAP test) for further information. Definitions # Page x

1 Specifications Equipment Performance Specifications 1.1 Electrical Safety Testing Standards - ANSI/AAMI-ES1 - NFPA 99 - IEC 60601 - IEC 62353 - IEC 61010 1.2 Safety Tests - Line or Mains Voltage - Point-to-Point Voltage - Accessible Voltage (IEC 61010) - Equipment Load Current - Power Cord or Protective Earth (PE) Resistance - Point-to-Point Resistance - Enclosure or Chassis Leakage Current (AAMI-ES1; NFPA 99) - Touch Current (IEC 60601; IEC 61010) - Earth Leakage Current (AAMI-ES1; IEC 60601) - Equipment Leakage Current (IEC 62353) - Point-to-Point Leakage Current - Lead Leakage to Ground or Patient Leakage (NFPA 99; AAMI-ES1; IEC 60601) - Lead Isolation or MAP Test (AAMI-ES1; IEC 60601; IEC 62353) Specifications/Chapter 1 # Page 1

1.3 Instrument Specifications 1.3.1 Voltage Measurement Line or mains voltage Range... 90 to 264 V rms Accuracy... ±(2 % of reading + 0.2 V) Point-to-point voltage Range... 0 to 300 V rms Accuracy... ±(1 % FS + 0.2 V) Accessible voltage Range... 0 to 150 V rms Accuracy... ±(1 % FS + 0.2 V) 1.3.2 Load Current Measurement Ranges... 0 to 1.999 A ac rms 2.00 to 19.99 A ac rms Accuracy... ±(2 % reading + 0.2A) Duty cycle... 0 A to 10 A, continuous 10 A to 15 A, 7 min. on/3 min. off 15A to 20 A, 5 min. on/5 min. off 1.3.3 Resistance Measurement Mode... Four-terminal, fully isolated Test Current... 1A pulsed, 0.2A rms Range... 0.000 to 2.000 ohm Accuracy... ±(1 % of reading + 0.01 ohm ) 1.3.4 Leakage Current Measurement Mode... True-RMS Patient Load Selection... AAMI or IEC Crest factor... <=3 Ranges... 0.0 to 199.9 :A 200 to 1,999 :A 2.0 to 19.99 ma Accuracy DC to 1 khz... ±(1 % of reading + 1 :A) 1 to 100 khz... ±(2 % of reading + 1 :A) 100 khz to 1 MHz... ±(5 % of reading + 1 :A) Isolation test voltage... 100 % ±5 % of AC supply Specifications/Chapter 1 # Page 2

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... Maximum Voltage... Maximum Current... CAT I 6V 200 ma RMS 1.4.3 Meter Input Terminals (EXT+/-) Category... CAT I Maximum Voltage External :A/mV mode... 20V External voltage mode... 300V Maximum Current... 0.2 ma @ 300V 1.4.4 AP Terminal Category... CAT I Maximum Voltage... 264 VAC (Isolation or MAP Test ) Maximum Current... 14mA AC @ 264 VAC Connect measurement terminals ONLY as instructed in this manual. See Chapter 4, Operation Specifications/Chapter 1 # Page 3

1.5 User Interface Display... 5" colour LCD (854 x 480) User Controls... Capacitive touchscreen Modes of Operation... Manual Specifications/Chapter 1 # Page 4

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. For instance, a single device should draw no more than 16A from a single receptacle on a 20A circuit. - Transient overvoltages typically present on the mains supply are expected to be impulse withstand (overvoltage) category II of IEC 60364-4-443 1.7 Externally-Accessible Fuses 20A / 250V AGC 1.8 Environment for Use 15 to 40 C 10% to 90% RH Altitude: 2000m max. Indoor use only Pollution Degree 2 1.9 Dimensions 8.4 x 6 x 3.7 in. (21 x 15 x 9.4 cm) 1.10 Weight 2.6 lb (1.2kg) Specifications/Chapter 1 # Page 5

1.11 Standard Accessories vpad Kelvin Cable... P/N 3140-475 Power Cord (country specific) North America 15A... P/N 3000-009 North America 20A... P/N 3000-010 Continental Europe... P/N 3000-011 United Kingdom... P/N 3000-012 Australia... P/N 3000-018 1.12 Optional Accessories For a complete list of available accessories, visit www.datrend.com or contact Datrend Customer Service (see Chapter 5 for contact details) 1.13 Compliance With Standards vpad-mini has been certified to meet the following safety standards: CAN/CSA-C22.2 No. 61010-1-(2 nd Edition) - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use, Part 1: General Requirements UL Std. No. 61010-1 (2 nd Edition) - Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements Following manufacture, all units are subjected to, and have passed the requirements of the Routine Tests defined in Annex F of the above Standard(s). Specifications/Chapter 1 # Page 6

2 Overview vpad-mini is a manually-operated electrical safety analyzer providing basic electrical safety testing of medical devices with patient leads. Although simple and easy to use, vpad-mini is nonetheless capable of performing many of the tests specified in electrical safety standards such as AAMI-ES1, NFPA 99, IEC60601, IEC62353 and IEC61010. 2.1 Analyzer Base Unit The vpad-mini safety analyzer is comprised of an Android -powered tablet which provides the user interface, and a Base Unit which provides the analyzer instrumentation. Referring to Figure 1, controls, interfaces and features of the Analyzer Base Unit are: Item Description/Function 1. AC supply input Connect to AC supply using line cord provided with vpad-mini 2. Line fuse Main supply fuse; replace with AGC 20A / 250V 3. AC supply indicator Lights when AC supply is connected to Base Unit 4. Test receptacle Connect to AC power input of Equipment Under Test (EUT) 5. Receptacle active indicator Lights when power is applied to test receptacle (4) 6. Meter input, EXT+/- Input to voltmeter or leakage measuring device 7. Current source, SRC+/- Current source output for four-wire resistance measurement 8. AP connection Connect to an applied part (AP) or patient lead of the EUT. To test EUT with multiple applied parts or leads, connect the leads to the AP jack of vpad-mini via the optional Applied Part Junction Box (P/N 7400-094). Overview/Chapter 2 # Page 7

Figure 1 - vpad-mini Base Unit. 2.2 Test Receptacle Configuration vpad-mini may be equipped with one of these test receptacles, but other receptacles may be substituted to satisfy customer requirements. For additional configurations, please contact Datrend Customer Service. North America Western Europe United Kingdom Australia/China Overview/Chapter 2 # Page 8

3 Setup Place vpad-mini on a stable, flat surface and open the case. Connect the power cord provided with vpad- Mini to the AC supply input located on the faceplate of the analyzer (Figure 2 ). Plug the power cord into a power outlet. Figure 2 Before proceeding, verify the "AC Power" indicator on the faceplate of vpad-mini is now illuminated (Figure 3 ). Figure 3 Setup/Chapter 3 # Page 9

Apply power to the Android tablet of vpad-mini by pressing and holding the power button at top left on the device until the LCD screen lights up (Figure 4 ). Approximately 60 seconds after switching ON, the main menu of vpad-mini should appear on the tablet (Figure 5 ). Figure 4 Figure 5 Switch the tablet OFF when vpad-mini 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 the tablet. This is NOT the same as OFF. To store or transport vpad-mini, reverse the setup procedure described above. Setup/Chapter 3 # Page 10

4 Operation 4.1 Main Menu The main menu of vpad-mini (Figure 6 ) is displayed approximately 60 seconds after switching the tablet ON. Figure 6 - vpad-mini main menu. The main menu of vpad-mini provides these functions: AC supply and point-to-point voltage measurements Load current measurement Power cord and point-to-point resistance tests Leakage current tests vpad-mini settings, including electrical safety standard and polarity switching delay Operation/Chapter 4 # Page 11

4.2 On-Line Help The vpad-mini app provides an on-line user's manual. Press the button on each vpad-mini menu to see setup and operating instructions, electrical safety standards information, safety limits and more. 4.3 Settings Press the button on the main menu of vpad-mini to access the settings menu (Figure 7 ). Figure 7 - vpad-mini settings menu. The electrical safety standard determines the types of tests provided by other menus of vpad-mini, and the test nomenclature. The safety standard may be set to AAMI-ES1; NFPA 99; IEC 60601; IEC 62353; or IEC 61010. Note the safety standard is displayed on the main menu, above the button. The polarity switching delay pertains to leakage current tests. This setting determines the length of time the test receptacle remains in the OFF state when the AC supply to the equipment is changed from normal to reverse polarity, or visa versa. The delay may be set to 2, 4, 6 or 8 seconds. The button accesses the system settings of the Android tablet. The Android Settings menu may be used to change display, sound and language settings of the tablet. To exit the Android Settings menu, press the button on the Android tablet, located near top right on the device. Press the button on the vpad-mini Settings menu to save changes and return to the main menu. Operation/Chapter 4 # Page 12

4.4 Voltage Tests Press the button on the main menu of vpad-mini to access the voltage test menu (Figure 8 ). Figure 8 - vpad-mini voltage menu. Press the large button at bottom center of the screen to change the type of voltage test. Mains voltage and point-to-point measurements may be selected. If desired, press the button at bottom right to apply power to the equipment under test via the vpad-mini receptacle. To return to the main menu, press the ON while the main menu is being shown. button. If the test receptacle has be switched ON, it will remain Press the button to see helpful information about voltage testing. Operation/Chapter 4 # Page 13

4.4.1 Terminology "Mains" is IEC terminology for the AC supply. "L1", "L2" and "G" symbols appear in schematic diagrams displayed by vpad-mini. Different terms apply to these symbols according to regional conventions or the electrical safety standard in use. Refer to the table below. Symbol IEC Terminology North American Terminology L1 AC mains line 1 "Hot" L2 AC mains line 2 "Neutral" G Protective Earth (PE) "Ground" 4.4.2 Supply Measurements L1-L2 is a measure of the mains or supply voltage which is input to vpad-mini. L1-G is a measure of the Line 1 voltage with respect to the mains PE or supply ground. L2-G is a measure of the Line 2 voltage with respect to PE or ground. All measurements are in volts RMS; maximum rated input is 264V. 4.4.3 Normal Supply When testing a domestic AC outlet, the L1-G voltage should be approximately equal to L1-L2. The L2-G voltage should be much smaller than L1-L2, and ideally should be equal to zero volts. 4.4.4 Reversed Polarity A reversed mains supply is indicated by L1-G approximately equal to zero volts, and L2-G approximately equal to L1-L2. Electrical safety testing should not be performed with a reversed mains. 4.4.5 Open Ground/Isolated Mains If L1-G and L2-G voltages are approximately equal to each other, and appear to be about one-half of L1-L2, the ground or PE connection of the mains supply may be open-circuit. Alternatively, a mains isolation transformer may be supplying the vpad-mini. In either case, the absence of a true ground or PE reference for the safety analyzer will produce leakage test results close to zero. Such results may be misleading unless the intent is to verify low-leakage performance of the equipment under test when it is intentionally connected to an isolated supply. Operation/Chapter 4 # Page 14

4.4.6 Point-to-Point Voltages To measure point-to-point voltages, connect probes to vpad-mini EXT(+) and EXT(-) jacks as shown in Figure 9. Maximum input for point-to-point measurements is 300V. Figure 9 - Point-to-point connections. 4.4.7 Mains Voltages By Region The table below summarizes nominal mains voltage and tolerance by region. The table is not exhaustive. If in doubt, consult applicable standards for your country. Rural or remote regions may experience temporary voltage fluctuations outside the specified range. Region L1-L2 (nominal) Tolerance Range Africa 230 V ± 10% 207-253 V Asia China Taiwan 230 V 220 V 110 V ± 10% ± 7% --- 207-253 V 204-236 V Australia 230 V +10 / -6 % 216-253 V European Union 230 V ± 10% 207-253 V Japan 100 V ± 10% 90-110 V North America 120 V ± 5% 114-126 V South America Brazil 230 V 127 or 220 V ± 10% --- 207-253 V United Kingdom 230 V +10 / -6 % 216-253 V Operation/Chapter 4 # Page 15

4.5 Load Current Test Press the button on the main menu of vpad-mini to access the load current test (Figure 10 ). Figure 10 - vpad-mini load current menu. To measure load current, connect the equipment under test (EUT) to the test receptacle of vpad-mini as shown in Figure 11. Figure 11 - Connect EUT to test receptacle. vpad-mini will automatically select 2 or 20 amp measurement range as required. The vpad-mini receptacle is activated on entry to this menu, and will remain ON after exiting this menu with the button. The receptacle will be switched OFF if the resistance test is then selected. For power-sensitive equipment, perform OEM-recommended shutdown procedures if testing ground resistance immediately after measuring load current. Alternatively, test ground resistance of the equipment first, then measure its load current afterward. Operation/Chapter 4 # Page 16

4.6 Resistance Tests Press the button on the main menu of vpad-mini to access the resistance test menu (Figure 12 ). Figure 12 - vpad-mini resistance menu. Press the large button at bottom center of the screen to change the type of resistance test. Power cord and point-to-point measurements may be selected. The test receptacle button at bottom right is enabled for point-to-point testing only. Press the button to switch EUT power ON or OFF as required. To return to the main menu, press the ON while the main menu is being shown. button. If the test receptacle has be switched ON, it will remain Press the button to see helpful information about resistance testing. Operation/Chapter 4 # Page 17

4.6.1 PE or Ground Resistance On entering the resistance menu, vpad-mini initially defaults to measurement of protective earth (PE) or grounding resistance. If the test receptacle is ON when a PE or ground resistance test is selected, the receptacle will be switched OFF automatically. When testing power-sensitive equipment in particular, OEM-recommended shutdown procedures should be performed after measurement of equipment load current or leakage current before the vpad-mini resistance menu is entered. Alternatively, ground resistance of the equipment may be tested first, and load current and/or leakages measured afterward. To measure PE or grounding resistance of Class I equipment with a three-wire power cord, connect the equipment's power cord to the test receptacle of vpad-mini as shown in Figure 13. Figure 13 - Connect EUT to test receptacle. Connect the Kelvin cable provided with vpad-mini to the SRC(+) and EXT(+) jacks of the safety analyzer (Figure 14 ). Figure 14 - Connect Kelvin Cable to vpad-mini. Operation/Chapter 4 # Page 18

Connect the Kelvin clip to a conductive point on the equipment enclosure or, if available, to a ground test point on the equipment as shown in Figure 15. Figure 15 - Connect Kelvin Cable to EUT chassis. 4.6.2 Point-to-Point Resistance To measure resistance point-to-point, two Kelvin cables are required (Figure 16 ). Connect one Kelvin cable to SRC(+) and EXT(+) jacks of the safety analyzer, and connect the second cable to EXT(-) and SRC(-). Connect the Kelvin clips to conductive accessible points on the equipment to be tested. Figure 16 - Point-to-point Kelvin connections. Operation/Chapter 4 # Page 19

4.6.3 Limits Limits for PE or ground resistance of equipment with a permanently-connected power cord are: Standard AAMI-ES1 NFPA 99 IEC 60601 IEC 62353 IEC 61010 Limit N / A 0.5 S 0.2 S 0.3 S 0.2 S Note: AAMI-ES1 specifies safe current limits only Limits applicable to other configurations of the equipment under test (EUT) are: Standard EUT Configuration Limit NFPA 99 IEC 60601 IEC 62353 IEC 61010 Equipment with detachable power cord: tested with cord connected Equipment with detachable power cord: cord disconnected; measured from chassis to PE terminal of EUT mains input Equipment with detachable power cord: tested with cord connected Equipment with detachable power cord: cord disconnected; measured from chassis to PE terminal of EUT mains input Equipment powered from RCD-protected accessory outlet: measured from EUT chassis to PE of primary mains supply Equipment with detachable power cord: cord disconnected; measured from chassis to PE terminal of EUT mains input 0.5 S 0.1 S 0.3 S 0.2 S 0.5 S 0.1 S Operation/Chapter 4 # Page 20

4.6.4 Method vpad-mini uses a four-wire method to measure resistance up to 2 ohms. The Kelvin Cable provides two independent conductors which convey the test current and sense voltage. A pulsed test current is used, equivalent to 200 ma RMS. Operation/Chapter 4 # Page 21

4.7 Leakage Current Tests Press the button on the main menu of vpad-mini to access the leakage current menu (Figure 17 ). Figure 17 - vpad-mini leakage current menu. Press the large button at top left on the screen to change the type of leakage current test. Available tests will depend on the electrical safety standard which has been chosen under vpad-mini settings, as described in Section 4.3. buttons at the bottom of the screen respectively control supply ground (earth) and neutral (line 2) connections at the test receptacle, and the supply polarity. Ground or neutral may be set to normal or single-fault condition (SFC), as represented by a switch icon which will appear closed for normal condition or open for SFC. Supply polarity may be set to normal (NP) or reverse (RP). Depending on the electrical safety standard in use, one or more of these buttons may be disabled or may be hidden, according to the allowable test conditions which have been specified in the standard. In accordance with all electrical safety standards supported by vpad-mini, the analyzer will not allow the user to select double-fault test conditions (i.e., ground open and neutral open simultaneously), unless the test being performed is earth leakage specifically. When receptacle polarity is changed, the receptacle is switched OFF for a set period before being reactivated with the new polarity. This is intended to protect the equipment under test (EUT) and/or vpad- Mini from damage due to surge currents. The polarity switching delay may be set to suit EUT characteristics or OEM test specifications; see vpad-mini settings, Section 4.3. Operation/Chapter 4 # Page 22

For testing medical devices that provide patient applied parts or "leads", some electrical safety standards specify a mains-on-applied-part (MAP) or lead isolation test. When this type of leakage test has been selected, the ground and neutral buttons on the menu are replaced by a button, which controls the MAP test voltage. The MAP test voltage is isolated from the AC mains supply and is current-limited to protect the user of vpad-mini. The applied part or lead leakage current is measured once the MAP voltage has been switched ON, which is represented by a icon on the button. The MAP voltage may be manually deactivated with the button; alternatively a timer will deactivate the voltage automatically after 20 seconds. The button returns the display screen to the main menu. On exiting the leakage test with polarity reversed or neutral open, the test receptacle will be switched OFF automatically. Otherwise, the test receptacle will remain ON when the main menu is displayed. Accordingly, when testing power-sensitive equipment you should perform OEM-recommended shutdown procedures if equipment grounding resistance is tested immediately after measuring chassis or other leakage current. Alternatively, test ground resistance of the equipment first, then measure leakage currents afterward. The button may be pressed to see helpful information about leakage testing, including leakage limits for the various safety standards. 4.7.1 Test Connections To measure leakage current, connect the power cord of the equipment under test (EUT) to the test receptacle of vpad-mini as shown in Figure 18. Figure 18 - Connect EUT to test receptacle. Operation/Chapter 4 # Page 23

Connect the Kelvin cable provided with vpad-mini to the SRC(+) and EXT(+) jacks of the safety analyzer (Figure 19 ). Figure 19 - Connect Kelvin Cable to vpad-mini. Connect the Kelvin clip according to EUT type: Class I or Class II. "Class I" EUT is equipment having a three-wire power cord which includes a ground (G) or protective earth (PE) conductor. For Class I EUT, connect the Kelvin clip to a conductive point on the enclosure or, if available, to a ground test point as shown in Figure 20. Figure 20 - Connect Kelvin Cable to Class I EUT. Operation/Chapter 4 # Page 24

"Class II" EUT is equipment having a two-wire power cord with no ground or PE conductor. For Class II EUT, connect the Kelvin clip to a conductive point on the enclosure if possible. If the enclosure is non-conductive, place the EUT on a metal sheet and connect the Kelvin clip to the sheet. For a small device, wrap in tin foil and connect to the foil. If the EUT has a patient lead or an applied part (AP), connect it to the AP jack of vpad-mini. If the EUT has multiple applied parts or leads, connect them to the optional Applied Part Junction Box (P/N 7400-094, Figure 21 ). Then, connect the output of the junction box to the AP jack of vpad-mini. ECG leads may be connected to the junction box by means of the optional ECG snap adaptor kit (P/N 7500-425). Figure 21 Use junction box P/N 7400-094 to connect multiple patient leads to AP jack of vpad-mini. vpad-mini allows for measurement of leakage current from one arbitrary conductive point to another. To perform this test, connect probes to vpad-mini EXT(+) and EXT(-) jacks as shown in Figure 22. Figure 22 - Point-to-point test connections. WARNING! DO NOT EXCEED 20V MAXIMUM INPUT WHEN PERFORMING POINT-TO-POINT LEAKAGE TESTS. Operation/Chapter 4 # Page 25

4.7.2 Abbreviations and Terminology The following abbreviations and terminology are used in test descriptions and in limit tables which appear in this manual. They also appear in the on-line help system and schematic diagrams displayed by vpad-mini. Abbreviation EUT Mains G PE N L2 NP RP NC SFC GNDN GNDO L2N L2O AP Type B Type F Type BF Type CF Description or meaning Equipment under test AC power supply to EUT AC supply ground or mains protective earth (PE) Mains protective earth or AC supply ground (G) AC supply neutral or mains line 2 (L2) Mains line 2 or AC supply neutral AC supply or mains in normal polarity condition AC supply or mains in reverse polarity condition Normal condition Single-fault condition Ground (G) or protective earth (PE) connection to EUT in normal condition (NC) Ground or PE connection to EUT "open", or in single-fault condition (SFC) Mains line 2 (L2) or neutral (N) connection to EUT in normal condition (NC) L2 or N connection to EUT "open", or in single-fault condition (SFC) Patient-applied part, lead or connection (for example, ECG) Body (non-isolated) patient-applied part (AP) Floating or isolated applied part (AP) Body floating (isolated) applied part (AP) Cardiac floating (highly isolated) applied part (AP) Operation/Chapter 4 # Page 26

4.7.3 Leakage Test Descriptions Refer to abbreviations and terminology (section 4.7.2) when reviewing test descriptions. Test Standard Description Enclosure Leakage Touch Current Chassis Leakage AAMI-ES1 IEC 60601 IEC 61010 NFPA 99 Measures leakage from EUT enclosure to AC supply Ground (G) or mains Protective Earth (PE). Test with EUT power switch OFF and ON, and with mains in Normal Polarity (NP) and in Reverse Polarity (RP). For each of these test conditions, measure leakage current with mains in normal condition (NC), then single-fault condition Ground Open (SFC GNDO), and finally single-fault condition neutral or Line 2 Open (SFC L2O).</td> See enclosure leakage Similar to enclosure leakage; measures leakage from EUT chassis to mains G or PE. Test with EUT power switch OFF and ON. For each EUT power condition, measure leakage current with mains in NC, and then SFC GNDO. Other test conditions such as mains RP or SFC L2O, which are specified by some safety standards, are not required by NFPA 99. Earth Leakage AAMI-ES1 IEC 60601 Measures leakage from EUT G or PE input to supply mains ground or earth. Test with EUT power switch OFF and ON, and with mains NP and RP. For each of these test conditions, measure leakage current with mains L2 normal, and then SFC L2O. Operation/Chapter 4 # Page 27

Test Standard Description Equipment Leakage IEC 62353 Measures combined leakage from EUT enclosure and applied parts (AP) to the mains G or PE. Test with all AP shorted together. Test with EUT power switch OFF and ON, and with mains NP and RP. Patient Leakage Lead-to-ground Leakage AAMI-ES1 IEC 60601 NFPA 99 Measures source current of EUT patient-applied parts (AP) or lead connections to mains G or PE. Test Type CF (isolated) leads individually, one at a time. Test Type B (non-isolated) and BF (isolated) leads of a given medical function shorted together. Test with EUT power switch OFF and ON, and with mains NP and RP. For each of these test conditions, measure leakage current with mains in NC, then SFC GNDO, and finally SFC L2O. Similar to patient leakage; measures source current of EUT patient leads to mains G or PE. Test with all leads shorted together. Perform the test with EUT power switch ON only. Test with mains in NC, and then SFC GNDO. Other possible test conditions such as EUT OFF or mains RP, which are specified by some safety standards, are not required by NFPA 99. MAP or Isolation Test AAMI-ES1 IEC 60601 Measures sink current of patient-applied parts (AP) or lead connections when driven by an isolated mains supply. Test only isolated (Type BF or CF) leads. Test Type CF leads individually, one at a time. Test BF leads of a given medical function shorted together. Test with EUT power switch OFF and ON, and with mains NP and RP. Operation/Chapter 4 # Page 28

Test Standard Description Applied Part Test IEC 62353 See MAP or isolation test. Test only isolated or Type F leads. Test leads of a given medical function shorted together. 4.7.4 AAMI-ES1 Limits Test NC SFC Enclosure Leakage 100 :A 300 :A Earth Leakage 500 :A 1000 :A Patient Leakage Non-isolated lead(s) 10 :A 100 :A Isolated leads 10 :A 50 :A Isolation Test (isolated leads only) n / a 50 :A 4.7.5 NFPA 99 Limits Test NC SFC Chassis Leakage 100 :A 500 :A Lead-to-Ground Leakage 100 :A 500 :A 4.7.6 IEC 60601 Limits Test NC SFC Touch Current 100 :A 500 :A Earth Leakage 5 ma 10 ma Type B 100 :A 500 :A Patient Leakage Type BF 100 :A 500 :A Type CF 10 :A 50 :A* Type BF n / a 5 ma MAP Test (isolated leads only) Type CF n / a 50 :A* * Note: Defibrillator paddles 100 :A, per IEC 60601-2-4 Operation/Chapter 4 # Page 29

4.7.7 IEC 62353 Limits Test Equipment Leakage Limit Class I 500 :A Class II 100 :A Applied Part Leakage (isolated leads only) * Note: Defibrillator paddles 100 :A, per IEC 60601-2-4 Type BF Type CF 5 ma 50 :A* 4.7.8 IEC 61010 Limits Test NC SFC Touch Current 500 :A 3.5 ma 4.7.9 Accessible Voltages The IEC 61010 standard defines voltage limits for user-accessible points on the EUT. Voltages are measured with respect to mains G or PE as shown in Figure 28. Figure 28 - IEC 61010 accessible voltage test. Per IEC 61010, accessible voltages must not exceed 33V with mains in NC or 55V with mains in SFC. For EUT used in wet locations, these limits are reduced to 16V NC and 33V SFC respectively. WARNING! DO NOT EXCEED 150V MAXIMUM INPUT WHEN PERFORMING ACCESSIBLE VOLTAGE TESTS. Operation/Chapter 4 # Page 30

5 Calibration and Maintenance Calibration of vpad-mini by a Datrend Authorized Service facility is recommended on an annual basis, and is required to extend the product warranty. The basic one (1) year warranty on the Analyzer Base Unit can be extended to a maximum of two (2) years provided that annual calibration is performed by a Datrend Authorized Service Center on an annual basis. Refer to the Calibration Decal applied to the rear panel of the unit to determine calibration status of your vpad-mini. vpad-mini contains no user serviceable parts, other than a 20 Amp/250V AGC fuse located on the left of the Analyzer Base Unit. Any other failure will require return of vpad-mini to an authorized service facility for repair. Opening the case of vpad-mini for any reason will void the warranty and may compromise user safety. Service must be performed by a factory trained, authorized service agent. This unit contains hazardous voltages which may cause injury if correct service procedures are not followed. 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: 800.667.6557 (North America Only) or +1.604.291.7747 Fax +1.604.294.2355 e-mail customerservice@datrend.com www.datrend.com vpad-mini may be cleaned with a soft, lint free, damp cloth using a mild detergent. Use of other cleaning agents on the touchscreen may result in scratching, discolouration, streaking or even failure. Maintenance/Chapter 5 # Page 31