Users Guide. Electrical Safety Analyzer

Transcription

1 180 Electrical Safety nalyzer Users Guide PN May Fluke Corporation, ll rights reserved. Printed in US. Specifications subject to change without notice. ll product names are trademarks of their respective companies.

2 Warranty and Product Support Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of original purchase. During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized Fluke Biomedical service facility. NO OTHER WRRNTIES, SUCH S FITNESS FOR PRTICULR PURPOSE, RE EXPRESSED OR IMPLIED. FLUKE SHLL NOT BE LIBLE FOR NY SPECIL, INDIRECT, INCIDENTL OR CONSEQUENTIL DMGES OR LOSSES, INCLUDING LOSS OF DT, RISING FROM NY CUSE OR THEORY. This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration of instruments is not covered under the warranty This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages, this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision. 07/07

3 Notices ll Rights Reserved Copyright 2007, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language without the written permission of Fluke Biomedical. Copyright Release Fluke Biomedical 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 Fluke Biomedical. 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 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. Technical Support For application support or answers to technical questions, either techservices@flukebiomedical.com or call or Claims Our routine method of shipment is via common carrier, FOB origin. 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 Fluke Biomedical or your local sales representative. Standard Terms and Conditions Refunds and Credits Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number tag) are eligible for partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases, auxiliary modules, etc.) are not eligible for return or refund. Only products returned within 90 days from the date of original purchase are eligible for refund/credit. In order to receive a partial refund/credit of a product purchase price on a serialized product, the product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods, and the product must be returned complete (meaning with all manuals, cables, accessories, etc.) and in as new and resalable condition. Products not returned within 90 days of purchase, or products which are not in as new and resalable condition, are not eligible for credit return and will be returned to the customer. The Return Procedure (see below) must be followed to assure prompt refund/credit. 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 %. dditional charges for damage and/or missing parts and accessories will be applied to all returns.

4 Return Procedure ll items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or ir Parcel Post. We also recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or handling. Use the original carton and packaging material for shipment. If they 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 nonabrasive material around all projecting parts. Use at least four inches of tightly packed, industry-approved, shock-absorbent material around the instrument. Returns for partial refund/credit: Every product returned for refund/credit must be accompanied by a Return Material uthorization (RM) number, obtained from our Order Entry Group at or Repair and calibration: To find the nearest service center, go to or In the U.S..: Cleveland Calibration Lab Tel: globalcal@flukebiomedical.com Everett Calibration Lab Tel: service.status@fluke.com In Europe, Middle East, and frica: Eindhoven Calibration Lab Tel: ServiceDesk@fluke.com In sia: Everett Calibration Lab Tel: service.international@fluke.com Certification This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical s manufacturing specifications when it was shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures. WRNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.

5 Restrictions and Liabilities Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers. Manufacturing Location The 180 Electrical Safety nalyzer is manufactured in Everett, Washington by Fluke Biomedical, 6920 Seaway Blvd., Everett, W, U.S..

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7 Table of Contents Chapter Title Page 1 Introduction and Specifications Introduction Simplicity Versatility General Safety Considerations Symbols Warnings and Cautions Key Features Instrument Familiarity Specifications ccessories Operation, Maintenance, and Service Preliminary Steps Preparing the nalyzer for Use Verifying the Power Outlet Connections Measuring Line Voltage Measuring Device Current Measuring Chassis Grounding Resistance Measuring Leakage Current Ground Leakage Current Chassis (Enclosure) Leakage Current Lead-to-Ground (Patient Source) Current Lead-to-Lead (uxiliary) Current Lead Isolation (Patient Sink) Current Point-to-Point Measurements Leakage Current Isolation Current Resistance Maintenance voiding Damage Cleaning Service and Calibration Packing Instructions Shipping ppendices bbreviations i

8 180 Users Guide ii

9 List of Tables Table Title Page 1-1. Symbols Components and Controls of the nalyzer Standard ccessories Optional ccessories List of Figures Figure Title Page 1-1. Fluke Biomedical 180 Electrical Safety nalyzer Block Diagram of a Typical DUT iii

10 180 Users Guide iv

11 Chapter 1 Introduction and Specifications Contents Page Introduction Simplicity Versatility General Safety Considerations Symbols Warnings and Cautions Key Features Instrument Familiarity Specifications ccessories

12 180 Users Guide 1-2

13 Introduction Introduction and Specifications Introduction 1 The Fluke Biomedical 180 Electrical Safety nalyzer, hereafter referred to as the nalyzer, is a highly versatile and portable instrument. It is used for the basic electrical safety evaluation of electrical systems, medical devices and physiological instrumentation. Its compact handheld size makes it an ideal addition to a service technician or engineer's toolbox for that "after service test" as well as serving as a bench top instrument for the laboratory. It does not sacrifice functions or accuracy, and its low cost permits putting one on each bench. Simplicity The nalyzer is simple to use. single master function switch, directly labeled with the test to be performed, leads the user through a complete measurement procedure. single range meter for each measurement avoids potential erroneous readings. The nalyzer utilizes simple, yet sophisticated, electronics for true-rms measurement of current and voltage. Input impedance uses the MI ES test load to compensate for high frequency components in the measurement. Resistance measurements are made with a four-wire Kelvin bridge to eliminate errors due to cable length and connector resistance. Versatility Unique to the nalyzer is its capability to make a broad range of point-to-point measurements. These include leakage current and/or voltage gradients and resistance between two points. lso, the nalyzer provides the voltage and measuring provision for the independent measurement of the isolation current of a device. Thus the nalyzer provides the additional versatility for evaluation of electrical systems, system installation, separate components, isolation of probes, transducers, and conventional leakage current measurements. 1-3

14 180 Users Guide General Safety Considerations This instrument and related documentation must be reviewed for familiarization with safety markings and instructions before you operate the instrument. Symbols Table 1-1 describes the symbols used in association with this instrument. Table 1-1. Symbols Symbol Description X W ~ CT I Hazardous voltage Important information; refer to manual. Do not dispose of this product as unsorted municipal waste. Go to Fluke s website for recycling information. IEC Measurement Category I CT I equipment designed to protect against transients in equipment on circuits not directly connected to MINS. Under no circumstances should the terminals of the nalyzer be connected to any MINS voltage. Warnings and Cautions Warning identifies hazardous conditions and actions that could cause bodily harm or death. Caution identifies conditions and actions that could damage the nalyzer, the equipment under test, or cause permanent loss of data. 1-4

15 Introduction and Specifications General Safety Considerations 1 XW Warning To avoid possible electrical shock or personal injury, follow these guidelines: Disconnect all patient connections before connecting the device to be tested to the analyzer. Continued connection may jeopardize patient safety by possible application of measurement currents. Maintain care when making connections. Isolation test utilizes 120 or 240 V ac applied to patient leads or to external connections that are accessible to the tester. lthough the voltage is current limited by 120 kω resistor per MI test procedure and is safe for healthy intact skin contact, it can be felt and can result in a startle reaction. Ensure the mains installation current rating is adequate for the device under test. If the device under test requires 20, the analyzer must be powered by a 20 service to avoid overloading the mains installation. W Caution To avoid possible damage to the nalyzer, follow these guidelines: Perform the dual lead leakage test only with an optional black test lead with the clamp with the red insulation (Fluke Biomedical part numbers or ) in the jack labeled DUL. Using a black test lead with the clamp with the black insulation in the DUL jack may result in a blown internal fuse and false readings of 000 to 002 μ, requiring the unit to be returned for servicing. Note For point to point measurements, optional accessory cables must be purchased. 1-5

16 180 Users Guide Ensure that the device under test power requirements are within the capabilities of the nalyzer, labeled as 20 at 120 V ac and 10 at 240 V ac. The nalyzer requires that adapter cables match the appropriate connector for line voltages other than 120V. Do not leave the device under test connected and drawing high load current for extended periods. The nalyzer is not designed for continuous measurements and may overheat. lways pause in the off (middle) position when switching polarity from normal to reverse. Inductive loads of the device under test may create high voltage transients when trying to reverse the direction of current flow instantaneously. Key Features Handheld instrument Test power line integrity Line voltage Instrument current Grounding resistance via 4-wire method Ground leakage current Enclosure (chassis) leakage current Patient (lead to ground) leakage current Patient (lead to lead) auxiliary current Patient isolation (sink) current Voltage gradients Device-to-device resistance Device-to-device leakage current Probe and transducer isolation current True-rms measurement MI test load 1-6

17 Instrument Familiarity Introduction and Specifications Instrument Familiarity 1 The nalyzer is shown in Figure 1-1, and Table 1-2 describes its labeled components rl ra OUTLET OK REV POL ELECTRICL SFETY NLYZER la ll C VOLTS 20 MP 5 MINUTES MX E K G µ - DUL - RESISTNCE - GROUND - CHSSIS - LED -GND - LED -LED L E V - LINE VOLTS - CURRENT LED la ll C ISO TEST CHSSIS DUL HZRDOUS LIVE VOLTGE DURING ISO TEST 12 NEUTRL CLOSED all OPEN OPEN GND OUTLET NORML 11 REVERSED OFF Figure 1-1. Fluke Biomedical 180 Electrical Safety nalyzer fat01.eps 1-7

18 180 Users Guide Table 1-2. Components and Controls of the nalyzer Label Name Function B C D E Power Cord Outlet Indicators Test Receptacle Outlet Switch Neutral Switch Supplies power to the Electrical Safety nalyzer and to the device under test (DUT). The measurement circuits are energized when the power cord is plugged into an outlet. There is no on/off switch. Verify the polarity and wiring of the outlet to which the nalyzer is connected. Only correctly wired outlets should be used. Not applicable to isolated power systems. Supplies power to the DUT. This outlet is powered if the OUTLET switch is set to NORML or REVERSED and the NEUTRL switch is CLOSED. If in the center off position, there is no power to the DUT receptacle. This switch permits testing with both normal (forward) and reversed polarity of the line. It is recommended that the switch be paused in the center OFF position before changing polarity. Note: Failure to pause the three-position switch in the OFF position may cause switch damage or blow the internal pico fuse. Permits making leakage current measurements under the OPEN condition as required by UL and IEC. 1-8

19 Introduction and Specifications Instrument Familiarity 1 Table 1.2. Components and controls of the nalyzer (cont.) F G H I J Lift Ground/ISO Test Switch Function Switch Lead Switch Meter Universal Patient Lead Terminals This is a dual-function momentary switch that must be held in position while performing the test. The OPEN GND position will open ground to the device for leakage current measurements. The ISO TEST position will energize the selected patient lead at 110 percent line voltage, current limited, to measure the isolation current when the main FUNCTION switch is in the LED ISO position. With the FUNCTION switch in the DUL position, the isolation test voltage is supplied to the DUL connector for measuring the isolation current of a probe or transducer. Provides direct, one-step selection of the measurement to be made. These are line V ac, instrument current, grounding resistance, ground (internal) and chassis (external) leakage currents, and the patient leakage currents. These include lead to ground (source), lead to lead (auxiliary) and isolation (sink) current. dual position is provided to measure leakage current between two points or isolation current of probes and transducers independent of their instruments. Directs the selected patient lead measurement to the desired lead. When testing a 10-lead device, a second pass will be required for the C leads. This is a large, ½ inch, high-contrast LCD, 3½digit display of the measured parameter. This will read up to 1999 with decimal points added where required. Provide means for connection of the patient leads for leakage current measurement. 1-9

20 180 Users Guide Table 1.2. Components and controls of the nalyzer (cont.) K L Chassis Connector Dual Connector Provides a means for inputting the chassis cable with its clip for connection to the DUT chassis or enclosure. The chassis ground resistance is measured with the FUNCTION switch in the RESISTNCE position, and the chassis leakage current is measured in the CHSSIS position. Used to make point-to-point measurements with optional leads available for purchase. For leakage and voltage measurements, the black cable with the clamp with black insulation is attached to the CHSSIS connector, and the black cable with the clamp with red insulation to the DUL connector. For point-to-point resistance measurements, the black cables with clamps with black insulation are attached to the DUL and CHSSIS connectors. Specifications The following are specifications for the nalyzer. Please contact your Fluke Biomedical service representative for more information regarding the device specifications. Line Voltage Range V ac 50/60 Hz ccuracy... ±3 % of reading, ±1 LSD Load Current Range ccuracy...±5 % of reading, ±1 LSD 1-10

21 Introduction and Specifications Specifications 1 Ground Resistance Range Ω ccuracy... ±1 % of reading, ±1 LSD Range Ω ccuracy... ±3 % of reading, ±1 LSD Current source m dc Type... 4-wire bridge Leakage Current Range μ ccuracy: DC and 25 Hz to 1 khz... ±1 % of reading, ±3 LSD 1.0 khz to 100 khz... ±2.5 % of reading, ±3 LSD 100 khz to 1 MHz... ±5 % of reading, ±3 LSD Type measurement... True rms Impedance Ω, MI ESI 1993 Isolation Test Voltage % Line voltage ±5% Current... limited by 120 kω resistor Current Capacity Line 90 to 140 V ac max. on time 5 min. 15 max. on time 30 min. Line over 140 V ac Current Consumption ES V 60 Hz Environmental Operating Temperature C Storage Temperature C Relative Humidity % max. Mains voltage range to 240 V ac 1-11

22 180 Users Guide ccessories The following are accessories for the nalyzer. To order, contact your Fluke Biomedical equipment dealer and use the Fluke Biomedical part numbers provided. Table 1-3 lists standard accessories shipped with the nalyzer; Table 1-4 lists optional accessories that must be ordered. Table 1-3. Standard ccessories Description Quantity Shipped Part Number Users Guide foot black cable with large clamp with black insulation Table 1-4. Optional ccessories Description 8-foot black cable with large clamp with black insulation (used for dual lead resistance) 16-foot black cable with large clamp with black insulation 8-foot black cable with large clamp with red insulation 16-foot black cable with large clamp with red insulation Part Number Soft carrying case V dapter kit

23 Chapter 2 Operation, Maintenance, and Service Contents Page Preliminary Steps Preparing the nalyzer for Use Verifying the Power Outlet Connections Measuring Line Voltage Measuring Device Current Measuring Chassis Grounding Resistance Measuring Leakage Current Ground Leakage Current Chassis (Enclosure) Leakage Current Lead-to-Ground (Patient Source) Current Lead-to-Lead (uxiliary) Current Lead Isolation (Patient Sink) Current Point-to-Point Measurements Leakage Current Isolation Current Resistance Maintenance voiding Damage Cleaning Service and Calibration Packing Instructions Shipping

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25 Operation, Maintenance, and Service Preliminary Steps 2 Preliminary Steps The nalyzer measures electrical parameters, as described below. These voltages and currents are a natural phenomenon, and their presence within reasonable limits does not constitute a hazard. However, it is necessary to measure their values to determine if there is a significant change from previous measurements or from the device specifications. Figure 2-1 is a block diagram of a typical line-operated instrument with patient connections. ll measured parameters are labeled, and the following topics are keyed to the labels in the diagram. CL ZI Hot IL Neutral Ground VL RL ZL CL Grounded Data and Control Circuits Isolated Patient Circuits I IE II IP RG Chassis 120/220 VC IC Enclosure Earth Figure 2-1. Block Diagram of a Typical DUT fat02.eps Preparing the nalyzer for Use WX Warning To avoid possible electric shock, burning of the skin, or personal injury to the patient, disconnect all patient connections to the device before starting the following procedure. 2-3

26 180 Users Guide Prepare the nalyzer for use as follows: 1. To start from the same position each time, place the nalyzer's switches in the following starting positions: FUNCTION switch LED switch NEUTRL switch OUTLET switch V- LINE VOLTS RL CLOSED OFF [center] 2. Plug the nalyzer into a properly rated outlet. The nalyzer is equipped with a hospital-grade power plug. Grounding reliability can be achieved only when the nalyzer is connected to an equivalent power receptacle marked "Hospital Grade." Grounding is important for personnel safety and to make some of the tests offered by the nalyzer. Do not circumvent this step for any reason. Verifying the Power Outlet Connections Note Not applicable to isolated power systems. Three neon lamps indicate the polarity and condition of the outlet being used, as shown in the following chart: REV OK Correct wiring Reverse polarity Open ground Open hot Open neutral Hot / ground reversed Note 2-4 Review all power outlets that do not indicate "correct wiring" and have them corrected by a qualified electrician. If the line is found faulty, correct the problem before proceeding. If the line checks OK, plug the device to be tested into the nalyzer's line receptacle.

27 Operation, Maintenance, and Service Measuring Line Voltage 2 WX Warning To avoid electrical shock due to faulty DUT, DO NOT touch the metal chassis, any accessible conductive part, or terminal of the DUT with mains power applied until all applicable tests have been completed and the product is verified as compliant. Keep fingers behind guards on supplied test accessories and/or remove power from the DUT before making necessary connections. Measuring Line Voltage Line Voltage [VL] is the mains power supplied by the electrical distribution system of the hospital. It is a three-wire system of HOT, NEUTRL, and GROUND, with NEUTRL, like GROUND, returned to true earth at their entry into the building. The nalyzer measurement is made between the HOT and NEUTRL wires via transformer coupling to isolate the measuring circuits from the line. s recommended, measurement of the line voltage with the device under test (DUT) OFF and then ON indicates whether the line is adequate for the device. Use the following steps to measure line voltage: 1. From the recommended start position, with the FUNCTION switch in the V - LINE VOLTS position, observe that the meter displays the line voltage with a resolution of one volt. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat03.eps 2. With the OUTLET switch in the NORML position and the DUT turned on, the meter continues to display line voltage, but under the load of the 2-5

28 180 Users Guide device being tested. Depending on the device's operating current and the electrical supply wiring, the voltage differential may be significant. 3. Check the value under load against the device's ratings to ensure that the actual value remains within prescribed limits. n excessive drop also suggests that a dedicated line of increased capacity should be run to the instrument. Measuring Device Current Device, or Instrument, Current [I L ] is the current used by the DUT. When turned on, the device should be operated in its various modes to determine the worst condition to track. Verify that the current of the DUT is within the current rating of the nalyzer being used. Measurement is made in the HOT wire via transformer coupling to ensure that the total current is measured, as it is possible that the NEUTRL and GROUND wire could share the return path. Use the following steps to measure device current: 1. Switch the FUNCTION switch to - CURRENT. The meter displays the device's current to V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat04.eps 2. Place the OUTLET switch in the NORML position; the NEUTRL switch remains in the CLOSED position. 3. Turn on the device and place it in its maximum load condition to obtain the proper reading. 4. Log this data to note changes in values that indicate early problems. 2-6

29 Operation, Maintenance, and Service Measuring Chassis Grounding Resistance 2 Measuring Chassis Grounding Resistance Note This test is only applicable to devices utilizing three-wire (grounded) power cords. Ground Wire Resistance [R G ] (grounding resistance) is the resistance from the device's conductive "grounded" chassis to the grounding terminal on the receptacle into which it is plugged. The resistance is largely composed of the GROUND wire in the power cable and is directly proportional to its length. Use the following steps to measure chassis grounding resistance: 1. Connect the standard cable supplied with unit that has a black cable with the clamp with black insulation to the CHSSIS connector on the front panel of the nalyzer. 2. Clamp the clip of the cable to the DUT's exposed chassis or the enclosure, if conductive. Resistance is measured between the clip on the black chassis cable and the grounding pin receptacle of the nalyzer. Take care to ensure that bare metal is reached and that both jaws of the clip are in contact with the chassis. Metal labels or incidental conductive hardware should not be used for this test. If a non-conducting enclosure is used and no chassis is readily accessible, a safety ground terminal can be used. 3. Once connection is made, rotate the FUNCTION switch to Ω - RESISTNCE and read its value directly in ohms to Ω. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat05.eps 2-7

30 180 Users Guide Note The OUTLET switch should be in the OFF (center) position for this measurement. Measuring Leakage Current Leakage current is the flow of current through or over the surface of an insulating material or insulator. For example, if a person comes in contact with an operational device, leakage current is the amount of current that flows from the point where the person came in contact with the device product, through the person s body, and back to ground. Measurement of leakage current is required on all mains power products. Ground Leakage Current Ground Leakage Current [I E ] (internal chassis current) is the current that flows in the ground wire of the power cable to return the chassis leakage current to true earth ground. It is only applicable to devices utilizing three-wire (grounded) power cords. This current does not constitute a hazard as long as the ground wire remains intact and the current does not become excessive. Leakage current is due to the proximity of the hot wire or line potential components to the chassis represented by Z L, a combination of capacitance, C L, and resistance, R L, components. Note The connection is made internally in the nalyzer, so no external connectors are required for this test. Use the following steps to measure ground leakage current: 1. Set the FUNCTION switch to GROUND. The leakage current is displayed to 1999 μ (microamperes). 2-8

31 Operation, Maintenance, and Service Measuring Leakage Current 2 V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat06.eps 2. Make measurements under all combinations of the OUTLET switch, NORML and REVERSE; the NEUTRL switch CLOSED and OPEN; and with the device power turned ON and OFF. Power to the outlet is OFF when the NEUTRL switch is in the OPEN position. Note Be sure to pause in the OFF (middle) position when switching the OUTLET switch from the NORML to the REVERSE position. Chassis (Enclosure) Leakage Current Chassis [Enclosure] Leakage Current [I C ] flows between the accessible conductive chassis or enclosure and earth (ground) measured through a 1,000 Ω impedance. The nalyzer measures chassis leakage from the exposed metal part on the DUT, through the black cable and the MI load, back to the ground. Use the following steps to measure chassis leakage current: 1. Connect the standard cable (supplied with unit) that has a black cable with the clamp that has black insulation to the CHSSIS connector on the front of the nalyzer. 2. Clamp the clip on the cable in turn to accessible conductive sections of the chassis and the enclosure. Metal labels or incidental conductive hardware are not applicable for this test. If a non-conducting enclosure is used, present standards require connection to the enclosure via a 200 cm² conductive foil in intimate contact with the enclosure. This can be accomplished with a 14 X 14 cm 2-9

32 180 Users Guide (5.5 X 5.5 in) piece of aluminum foil taped to the surface and the cable clipped to the foil. 3. To make the measurement, place the FUNCTION switch in the CHSSIS position and read the display in microamperes. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat07.eps 4. Make measurements under all combinations of the OUTLET switch, NORML and REVERSE; the GROUND switch CLOSED and OPEN; the NEUTRL switch CLOSED and OPEN; and with the device power turned ON and OFF. Power to the outlet is OFF when the NEUTRL switch is in the OPEN position. Note Be sure to pause in the OFF (middle) position when switching the OUTLET switch from the NORML to the REVERSE position. Lead-to-Ground (Patient Source) Current Lead-to-Ground [I P ] (patient source) current would flow between an individual patient lead and ground if the patient were to come into contact with earth ground. n example is a patient with leads attached touching ground such as an electric bed Note lthough originally required only for devices incorporating intracardiac electrodes or conductive pathways directly to the heart, leadto-ground current has found its way into standards for all devices having patient-applied parts.

33 Operation, Maintenance, and Service Measuring Leakage Current 2 Use the following steps to measure lead-to-ground current: 1. Connect the patient leads to the corresponding snaps on the top of the nalyzer. If the device has 10 leads, connect the limb leads and C1 (V1) initially and repeat with C2 (V2) through C6 (V6). Lead nomenclature for this test is not important. 2. Select LED-GND with the FUNCTION switch and read leakage current in microamperes for any combination of the patient lead selected by the LED switch. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat08.eps 3. Make measurements under all combinations of the OUTLET switch, NORML and REVERSE; the LIFT GROUND switch CLOSED and OPEN; and the device power turned ON and OFF. 4. Rotate the LED switch to each lead to test individually and then to LL for testing with all leads connected together. LED rl ra la ll c all fat17.eps Current measured should be the same for all leads, including the LL position, as the current represents the isolation impedance to the patient circuit. 2-11

34 180 Users Guide Lead-to-Lead (uxiliary) Current Lead-to-Lead [I ] (auxiliary) current flows from any patient lead to any other patient lead and to all other leads connected together. The current can be dc or ac or a combination of both. Measurements are made with a true-rms converter to provide the common base necessary for accurate readout with a variety of common wave forms. Under normal conditions, the current is primarily input bias current, measurement current, or lead off sensing current. The worst-case condition is measured from the individual lead to all others connected together. This is the measurement made by the nalyzer. Use the following steps to measure lead-to-lead current: 1. Connect the patient leads to the snaps on top of the nalyzer. 2. Set the FUNCTION switch in the LED-LED position. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat09.eps 3. Make readings for individual leads, selecting by the LED switch. The single lead carrying the most current is the reference lead, R L, acting as the return for the other leads. LED rl ra la ll c all fat12.eps 2-12

35 Operation, Maintenance, and Service Measuring Leakage Current 2 Note The LL position has no meaning in this test. 4. Make measurements under all combinations of the OUTLET switch, NORML and REVERSE; GROUND CLOSED and the LIFT GROUND switch OPEN; and the device power turned ON and OFF. 5. If the DUT utilizes a 10-lead patient input, test each C (V) lead in turn, individually. Lead Isolation (Patient Sink) Current Lead Isolation [I I ] (patient sink) current would flow into the DUT if the patient were to come into contact with full line voltage. n example is an electric bed that has become ungrounded and has a short to the frame. WX Warning To avoid possible electric shock, burning of the skin, or personal injury to the patient, take care when handling the patient leads. High voltage, 110 percent of line volts, with respect to earth ground is accessible at the patient connections (snaps) during part of this test. The patient lead isolation current can flow in individual leads or all leads connected together if line volts come into contact with the patient. Use the following steps to measure lead isolation current: 1. ttach the patient leads to the snaps on top of the nalyzer, making sure that ground is intact. 2. Set the FUNCTION switch in the LED ISO position. 2-13

36 180 Users Guide V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat10.eps 3. Test individual leads, selecting by the LED switch. 4. To apply the high voltage to the lead safely, press the LIFT GROUND/ISO TEST switch to ISO TEST. The current is limited with a 120 kω resistor for user protection. 5. While ISO TEST is energized, read the isolation current in microamperes. 6. Perform the test using the OUTLET switch in both NORML and REVERSE, the NEUTRL switch CLOSED, and with the DUT ON and OFF. Point-to-Point Measurements The nalyzer provides the capability of making point-to-point leakage current, isolation current, and resistance measurements between selected points, otherwise known as a dual lead measurement. Note dditional optional accessory cables must be purchased to perform these tests. Leakage Current Leakage Current between two points is also measured for permanently installed equipment as additional verification of the integrity of the installation. These measurements are equivalent, as the relationship between volts and current across 1,000 Ω is one mv per μ. 2-14

37 Operation, Maintenance, and Service Point-to-Point Measurements 2 Use the following steps to measure leakage current between two points: 1. To isolate the measurement circuit from ground, do not plug any device into the nalyzer's receptacle. 2. Connect the black cable with the clamp with black insulation to the CHSSIS connector and the black cable with the clamp with red insulation to the DUL connector. 3. Set the FUNCTION switch in the DUL position. V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat11.eps 4. Clip the two cables to the two points for which the leakage current is to be measured. The meter displays the leakage current between the two points to 1999 µ. The number displayed is also the voltage gradient in millivolts between the two points based on a volt meter with an input impedance of 1000 Ω. Isolation Current Isolation testing of probes and transducers making internal contact to a patient is provided to ensure the reliability of the isolation barrier. These devices incorporate electrical circuits that can introduce or sink hazardous currents to a patient who comes into contact with line potential or who becomes grounded, as previously described. Use the following steps to measure isolation current between two points: 1. To isolate the measurement circuit from ground, do not plug any device into the nalyzer's receptacle. 2-15

38 180 Users Guide 2. Connect the black cable with the clamp with black insulation to the CHSSIS connector and the black cable with the clamp with red insulation to the DUL connector. 3. Toggle the LIFT GROUND/ISO TEST switch to ISO TEST to apply isolated line voltage between the two sides. The meter displays the isolation current that flows. Note The actual method for making connection to either side of the isolation barrier varies with the device to be tested; therefore, full details are not provided. W X Warning To avoid possible electric shock, burning of the skin, or personal injury take care when handling the cables. High voltage, 110 percent of line volts, will be accessible between the two cables when the LIFT GROUND/ISO TEST switch is in the ISO TEST position. Resistance Resistance measurements between two points are made to verify the integrity of permanently installed equipment whose ground cannot be broken to measure the chassis leakage current. These are usually high-power devices that can have high leakage currents and depend on the bonding of all chassis to a common point for safety. To measure resistance between two points, follow the steps below: 1. Disconnect any device attached to the nalyzer instrument receptacle. 2. Turn off any electrical devices to be tested. 3. Connect two black cables with clamps with black insulation to the CHSSIS and DUL connectors, and clip onto the two points to be measured. 4. Set the FUNCTION switch to Ω - RESISTNCE, and the display will show the resistance between the two points. 2-16

39 Operation, Maintenance, and Service Maintenance 2 V - LINE VOLTS - CURRENT - RESISTNCE L - GROUND E - CHSSIS K - LED -GND G - LED -LED E - LED ISO µ - DUL fat05.eps 5. To compensate for possible dc components in the leakage current flowing between the two points, reverse the two clips and average the readings. Maintenance The nalyzer requires little maintenance or special care; however, it is a calibrated measuring instrument and should be treated as such. The following describes how to maintain the nalyzer. voiding Damage Do not drop the instrument or subject it to any mechanical abuse that could cause a shift in the calibrated settings. W Caution To avoid damage to the nalyzer or adverse affects on its performance, follow these guidelines: Do not expose the system to temperature extremes. mbient temperatures should remain between 15 C and 40 C. System performance may be adversely affected if temperatures fluctuate above or below this range. Cleaning Clean the exterior of the nalyzer occasionally with a cloth dampened with a mild detergent solution. Take care to keep liquids out of the device. 2-17

40 180 Users Guide W Caution To avoid damage to the nalyzer or adverse affects on its performance, clean it only by gently wiping down with a clean, lint-free cloth dampened with a mild detergent solution. Do not spray liquids on or immerse the unit. Carefully wipe down the cables and inspect them for damage and deterioration of the insulation. Check the cable connections for integrity of the cable clamp and strain relief. Service and Calibration If your new nalyzer fails to operate successfully, please contact Fluke Biomedical Service Center immediately, as indicated under Warranty and Product Support. W Caution To avoid damage to the nalyzer or adverse affects on its performance, allow only qualified technical personnel to service the nalyzer. nnual calibration of the nalyzer by an authorized Fluke Biomedical Service Center is recommended. Fluke Biomedical Service Centers have the appropriate tools and procedures for performing calibrations as well as factoryauthorized updates. International customers should contact their Fluke Biomedical dealers for service/product support. To obtain the name of your local dealer or service center, contact Fluke Biomedical as indicated under Return Procedures, Repair and calibration. Packing Instructions If repairs are required, return the nalyzer to the factory or the nearest service center, as follows: 1. Before returning the nalyzer for factory service, contact the Fluke Biomedical Service Center for a required Return uthorization Number. 2. Provide the following information: 2-18

41 Operation, Maintenance, and Service Service and Calibration 2 The nalyzer serial number The specific steps that reproduce your problem daytime phone number Your name/company fax number (if available) 3. Pack the instrument carefully, using the original packing materials. If the original packing materials are not available, refer to Return Procedures for a list of preferred materials or contact Fluke Biomedical for replacement packing. Failure to pack the instrument properly could void your warranty. Shipping 1. Place the Return uthorization Number in a prominent place on the outside of the packing box, and refer to the number in any correspondence with Fluke Biomedical Service. 2. Enclose your return address and Return uthorization Number. 3. Insure the unit for full retail value and ship to the nearest Fluke Biomedical service center. 2-19

42 180 Users Guide 2-20

43 ppendices ppendix Title Page bbreviations... -1

44 180 Users Guide

45 ppendix bbreviations bbreviations The following list includes abbreviations used in this document. NSI MI db ampere merican National Standards Institute ssociation for the dvancement of Medical Instrumentation decibel C degrees Celsius (centigrade) DUT ECG EUT device under test electrocardiograph or electrocardiogram equipment under test F degrees Fahrenheit Hz in hertz inch k kilo (10 3 ) khz kω LED kilohertz kilohm light-emitting diode M meg(a) (10 6 ) MHz MΩ megahertz megohm -1

46 180 Users Guide m meter m milli (10-3 ) m mm mv s milliampere millimeter millivolt second µ micro (10-6 ) µ microampere µv microvolt Ω ohm -2