QA-ST User and Service Manual
Contents
1. gt 03 0 O O S O N 1 Line Voltage Measurement Range 0 300V Accuracy 196 reading 1 digit 1 For North American QA ST Version 1 1 Resolution 1 V L N Current Capacity 15 Amps 100 Volts 15 Amps 120 Volts 10 Amps 230 Volts Resistance Measurement DC Source Range 0 19 99 Ohms Accuracy 2 reading 1 digit Resolution 0 01 ohms Current Source 100 mA DC AC Source Range 0 1999 mOhms Accuracy 2 reading 1 digit Resolution 1 mOhm Current Source 200 mA AC Leakage Current Range 0 1999 uA RMS Accuracy DC and 25 to 1 0 kHz 296 reading 1 digit 1 0 kHz to 100 kHz 2 5 R x 1 digit 100 kHz to 1 MHz 5 0 R x 1 digit Resolution 1 pA Input Impedance 1000 ohm AAMI ES1 1993 load or IEC 60601 1 load Power Consumption 50 60 Hz 200 mA 115 V 50 60 Hz 200 mA 240 V 50 60 Hz 100 mA 2 0500o sotto 3 70735 1 6 Temperature Requirements 15 59 to 35 95 C F while operating 0 to 50 122 C F for storage Display Type LCD Numeric format 4 characters Display control Keypad Power 100V 110V or 230V 240V 50 60 Hz Housing Plastic case Physical Dimensions D x W x H 191mm x 135mm x 45mm 7 5 in x 5 3 in x 1 8 in Weight 930 g 2 0 Ibs PA7OANH DOF gt 9 3 OFS TOS 7 sock Order no 11040 QA ST Electrical Safety Analyzer Specify power supply socket Standard Accessories2. METRON AS internall Comments Received date Correction date NORWAY Travbaneveien 1 N 7044 Trondheim Norway Phone 47 7382 8500 Fax 47 7391 7009 E mail support metron no Serial no Critical Normal B 1 USA 1345 Monroe NW Suite 255A Grand Rapids MI 49505 Phone 1 888 863 8766 Fax 1 616 454 3350 E mail sSupport us metron biomed com From name Address FRANCE 30 rue Paul Claudel 91000 Evry France Phone 33 1 6078 8899 Fax 33 1 6078 6839 E mail info metron fr NORWAY Travbaneveien 1 N 7044 Trondheim Norway Phone 47 7382 8500 Fax 47 7391 7009 E mail support metron no Improvement Suggestion Product Description of the suggested improvement METRON AS internall Comments Received date 1 Version Correction date Critical Normal USA FRANCE NORWAY 1345 Monroe NW Suite 255A 30 rue Paul Claudel Travbaneveien 1 Grand Rapids MI 49505 91000 Evry France N 7044 Trondheim Norway Phone 1 888 863 8766 Phone 33 1 6078 8899 Phone 47 7382 8500 1 616 454 3350 33 1 6078 6839 47 7391 7009 E mail Support us metron biomed com E mail info metron fr E mail support metron no METKON Es
3. Test lead Power lead The purpose of this test is to determine if there is any leakage cur rent between DUT Enclosure chassis and Mains Supply Ground 1 Connect the Kelvin Clamp to the chassis of the DUT 2 Press Leakage current Ext Case Leakage Current Ext Case 3 The value will be displayed on the LCD Note the value 4 Next press Outlet Supply RS Reversed Supply The dis played QA ST value may change 5 Then press Outlet Supply OG Open Ground The dis played QA ST value may change v Outlet Supply es avor es O77 r The purpose of this test is to determine if there is any patient leakage current between DUT Enclosure chassis and Mains Supply Ground 1 Connect all patient leads to the QA ST starting with lead 1 then lead 2 and so forth 2 Press Patient leakage current lead to lead Patient leads Instrument under test Test lead QA ST Patient leakage current lead tolead 3 The result will be displayed on the LCD Note the value 4 Press lead to lead to change the patient lead number The diode panel will display in binary format the number of the actual patient lead that is under test 10 ces OFDM es O77 CQO om or o5co Q The purpose of this test is to determine if there is any leakage cur rent between all the patient leads in parallel and DUT Gr
4. Press Leakage current Ext Case Leakage Current Ext Case 8 Adjust the voltage until the ammeter displays the first refer ence value in the test protocol QA ST will display the same value as the reference ammeter Note the value 9 Next press Outlet Supply RS Reversed Supply The dis played QA ST value will not change 10 Then press Outlet Supply OG Open Ground The dis played QA ST value will not change 07 Outlet Supply 7 Perform the test for tall the given values in the test protocol under Leakage Current Ext Case Reference cs UO avor Fe Q t t Z Q om or The purpose of this test is to determine if there is any patient leakage current between DUT Enclosure chassis and Mains Earth 5 Connect a voltage source in series with an ammeter and 10KQ resistance as shown below 10 6 METR N QA ST Safe Press Patient leakage current lead to lead Patient leakage current lead tolead 7 Adjust the voltage until the ammeter displays the first reference value in the test protocol QA ST will display the same value as the reference ammeter Note the value 8 Press lead to lead to change the patient lead number The diode panel will display in binary format the number of the actual patient lead that is under test Perform the test for tall the given values in the test protocol under Patient Leakage Current
5. carry the weight of the unit e at least 5 cm of shock absorbing material around the unit e nonabrasive dust free material for the other parts Repack the unit in a manner to ensure that it cannot shift in the box during shipment METRON s product warranty is on page ii of this manual The war ranty does not cover freight charges C O D will not be accepted without authorization from METRON or its Sales Agent This page intentionally left blank 3 Operating the QA ST This chapter describes the controls and terminals of the QA ST Safety Tester Patient Leads 3 7 METKeN QA ST Safety Tester Patient Leads 1 2 Patient Leads 8 10 100pA Test Point 1 00 Test Enclosure Point Kelvin Clamp Supply Ground Wire Res Leakage Current Port D irt Case Ext Case Buttons for mode operation selection Outlet Supply Inlet Supply niet Supply Supply Condition HE Ker S Indicators High Voltage on Patient Leads Caution LED Outlet Supply Status LEDs eje e e ejje j oc RS ON Lead Config High Outlet Supply Measurements Patient Lead Selected LEDs Displays in binary format values 0 10 Remove the batteries and dis connect the AC Adapter Bat tery Eliminator if you do not in tend to use the PS 410 for an extended period of time Inlet supply condition indicators Input Power Condition Inlet Power Condition LEDs Lit G Yellow G X X
6. is due to a manufacturing defect In no event will METRON or its local representa tives be liable for direct indirect special incidental or consequential damages arising out of the use of or inability to use the QA ST Safety Tester even if advised of the possibility of such damages METRON or its local representatives are not responsible for any costs loss of profits loss of data or claims by third parties due to use of or inability to use the QA ST Safety Tester Neither METRON nor its local representatives will accept nor be bound by any other form of guarantee concerning the QA ST Safety Tester other than this guarantee Some jurisdictions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Table of Contents 1 INTRODUCTION edel ete Bebe aai unes 1 1 134 Features noe iet en pt t e Dome be uote ER dn 1 1 1 255 p6ecIflCatlODs oett k fred scient 1 1 1 9 General Itiformaltion uuu eren Mote re te e nnd ern de at 1 2 2 INSTALLATION eii Haee etre qi e rei e E rea end pp cedes 2 1 2 1 Receipt Inspection and Return noinine ntt apa ao Ree kr pe ear dne ER Rn 2 1 3 OPERATING QA ST Res URDU ame ed ETE 3 1 4 QA ST SAFETY TESTS rito bp ede pM 4 1 4 1 Linearity Test of Voltmeter Lead to Lead em 4 1 42 MainsSupply Voltage ee ee e rete
7. 11045 User Service Manual QA ST 17290 Test Lead Kelvin Cable Various power supply socket including European Schuco French Schuco UK Swiss Australian US Optional Accessories 11041 Carrying Case 2 Installation This chapter explains unpacking receipt inspection claims and the general procedures for QA ST setup 2 2077 00 0035 5000 J gt 5 R e t r n 1 Inspect the outer box for physical damage 2 Carefully unpack all items from the box and check to see that you have the following items e QA ST Electrical Safety Analyzer P N 11040 e User Service Manual QA ST P N 11045 e Test Lead Kelvin Cable P N 17290 e Specified power supply socket 3 If you note physical damage or if the unit fails to function accord ing to specification inform the supplier immediately When METRON or the company s Sales Agent is informed measures will be taken to either repair the unit or dispatch a replacement The customer will not have to wait for a claim to be investigated by the Sales Agent The Customer should issue a new purchase order to ensure delivery 4 When returning an instrument to METRON or the Sales Agent fill out the address label describe what is wrong with the instru ment and provide the model and serial numbers If possible use the original packaging material for return shipping Otherwise repack the unit using e a reinforced cardboard box strong enough to
8. A ST 5 5 lt lt 5 o ra The purpose of this test is to calibrate the display voltmeter 2 Connect a voltage source in series with an ammeter and 10KQ resistance as shown below QA ST 6 Press Patient Current Lead to Lead Patient leakage current lead tolead Adjust the voltage source until the ammeter displays 1000pA Then adjust the QA ST potentiometer R63 see Appendix A for location until the QA ST LCD displays the same 1000HA value 5 2 lt ococo The purpose of this test is to calibrate the QA ST to display the rect mains voltage 3 Press Supply V Supply 4 Adjust the mains voltage with an external variable AC voltage VARIAC source Then adjust the QA ST potentiometer R67 see Appendix A for location until the QA ST LCD displays the same value 5 Perform the test for tall the given values in the test protocol under Mains Supply Voltage Reference 5 5 The purpose of this test is to determine if there is DC resistance between the cabinet of the device under test or DUT and the Mains Earth on the DUT 4 Press Ground Wire Res DC QA ST will display over range 1 Ground Wire Res 5 Connect a Test Lead in series with an ammeter directly to DUT Earth QA ST will
9. I N 4 2 z z z z L Live N Neutral G Ground NC Not connected X ON O Off Binary display format 10 6 __ ____ _______ a _ 9 p p 4 QA ST Safety Tests This chapter describes QA ST safety tests by function If you are un familiar with the simulators basic operation refer to paragraph 3 3 Operating QA ST NOTE When the QA ST is initially powered up the unit will be in a default condition At this time no measurements are being per formed 4 1 20 o The purpose of this test is to test for any leakage current between patient leads applied parts 1 Connect patient leads to the QA ST starting with port 1 then 2 and so forth 2 Press Patient Current Lead to Lead Patient leakage current lead tolead 3 The result for Lead 1 will be displayed on the LCD display To test Lead 2 press Patient Current Lead to Lead Observe that the lead under test number is indicated in binary format by the LEDs in the Measurements area located below the LCD display Instrument under test Test lead Power lead Patient leads GAST LE Tester Instrument under test Test lead Power lead Instrument under test Test lead Power lead rrythmias Premature Beats gt The purpose of this test
10. Lead to Lead Reference 20o 7 0 g es O77 CQO om or o5co Q The purpose of this test is to determine if there is any leakage cur rent between all the patient leads in parallel and DUT Earth 5 Connect a voltage source in series with an ammeter and 10KQ resistance as shown below 11 12 5 Safety Tester 6 Press Patient leakage current lead to GND Ground Patient leakage current m leadto GND T e Adjust the voltage source until the ammeter displays the first reference value in the test protocol QA ST will display the same value as the reference ammeter Note the value Perform the test for all the given values in the test protocol under Patient Leakage Current Lead to GND Reference 5 8L eak age Cur rent Lead to 150 The purpose of this test is to determine the quality of isolation be tween the DUT chassis and all of the patient leads in series 5 Connect Kelvin test leads in series with an ammeter and a reference resistance to one of the patient leads see below Note that all patient leads are connected internally within the QA ST to the same potential QA ST Safety Tester Earth 6 Press lead ISO of ON Lead Config High Measurements J Volt 7 Adjust the voltage source until the ammeter displays the first ref erence value in the test protocol QA ST should display the same value as th
11. QA ST User and Service Manual QA ST Safety Tester North American Version 1 1 Copyright 2000 by METRON All rights reserved METRON USA FRANCE NORWAY 1345 Monroe NW Suite 255A 30 rue Paul Claudel Travbaneveien 1 Grand Rapids MI 49505 91000 Evry France N 7044 Trondheim Norway Phone 1 888 863 8766 Phone 33 1 6078 8899 Phone 47 7382 8500 Fax 1 616 454 3350 Fax 33 1 6078 6839 Fax 47 7391 7009 E mail support us metron biomed com E mail info metron fr E mail support metron no Disclaimer METRON provides this publication as is without warranty of any kind either express or implied in cluding but not limited to the implied warranties of merchantability or fitness for any particular purpose Further METRON reserves the right to revise this publication and to make changes from time to time to the content hereof without obligation to METRON or its local representatives to notify any person of such revision or changes Some jurisdictions do not allow disclaimers of expressed or implied war ranties in certain transactions therefore this statement may not apply to you Limited Warranty METRON warrants that the QA ST Safety Tester will substantially conform to published specifica tions and to the documentation provided that it is used for the purpose for which it was designed METRON will for a period of twelve 12 months from date of purchase replace or repair any defective simulator if the fault
12. blank Manual Revision Record This record page is for recording revisions to your QA ST User and Service Manual that have been published by METRON AS or it s authorized representatives We recommend that only the man agement or facility representative authorized to process changes and revisions to publications e the pen changes or insert the revised pages e ensure that obsolete pages are withdrawn and either disposed of immediately or marked as superseded and placed in a superseded document file and e enter the information below reflecting that the revisions have been entered Rev No Date Entered Reason Signature of Person Entering Change vi This page intentionally left blank 1 Introduction This chapter describes the METRON QA ST Safety Tester s features and specifications 1 nonrc tO O N The QA ST is designed to quickly check electrical safety on medical and industrial devices It is palm sized and very portable The tests can be performed manually or in step by step mode The results are displayed in a bright 4 digit LCD display The QA ST performs all electrical safety tests necessary to satisfy AAMI ESI NFPA 99 VDE 701 VDE 751 and 95 It also features differential current measurements obtained by an internal current clamp This presents a new leakage current measurement technique for convenient testing of medical equipment with a fixed power cord hardwired to wall not detachable
13. display 102mA 2 6 Next connect as shown in the below figure without the am meter and test leads METReN QA ST Safety Tester Perform the test for tall the given values in the test protocol un der Ground Wire Resistance DC Reference 5 41 rent Inter nal Case The purpose of this test is to determine if there is any leakage cur rent between DUT Earth and Mains Earth 5 Connect a voltage source in series with an ammeter and 10KQ resistance as shown below METR N _ QA ST Safety Tester 6 Press Leakage current Int Case Leakage Current Int Case 7 Adjust the voltage until the ammeter displays the first refer ence value in the test protocol QA ST will display the same value as the reference ammeter Note the value e Next press Outlet Supply RS Reversed Supply The dis played QA ST value will not change 9 Then press Outlet Supply OG Open Ground The dis played QA ST value will not change Le Outlet Supply 10 Perform the test for tall the given values in the test protocol under Leakage Current Int Case Reference 5 5Le akage Cur rent Exter nal Case The purpose of this test is to determine if there is any leakage cur rent between DUT Enclosure chassis and Mains Earth 6 Connect a voltage source in series with an ammeter and 10KQ resistance as shown below METR N 5 Safety Tester 7
14. e reference ammeter Note the value If the ammeter value is not the same as the reference value adjust the mains using potentiometer R67 See Appendix A lead ISO 13 14 8 Perform the test for tall the given values in the test protocol der Leakage Current to ISO Reference ion Appendix A Circuit Board Schematic North American Vers UOISJ9A LS VO 104 uogisod c1 V1 5 suiew om C ueb juguno 1sn py JeuuoJsue jueuno 10J99ULOD f 10 10 599uuoo surew ysnipy JO UOWeIqUeD JO 2 53100 189 1 129 05 VE Aad 1570 NOHL3IN OL pue 6 8 Z L SoN pego juangg 10129Uu07 4 e SON ped 104 5 A 1 This page intentionally left blank USA 1345 Monroe NW Suite 255A Grand Rapids MI 49505 Phone 1 888 863 8766 Fax 1 616 454 3350 E mail sSupport us metron biomed com From name Address Product FRANCE 30 rue Paul Claudel 91000 Evry France Phone 33 1 6078 8899 Fax 33 1 6078 6839 E mail info metron fr Error Report Version Description of the situation prior to the error Description of the error
15. eei ee 4 2 4 3 Ground Wire Resistance DC u ciet e denn ate eu dnd 4 3 4 4 Leakage Current Internal Case r 4 4 4 5 Leakage Current External Case a 4 5 4 6 Patient Leakage Current Lead to a 4 6 4 7 Patient Leakage Current Lead to Ground ssessseeeeen eee 4 7 4 8 Leakage Current Lead to ISO a 4 8 5 CALIBRATION one er RO RH ERE EET Y ERE ee 5 1 5 1 Linearity Test of Voltmeter Lead to Lead 5 1 5 2 Mains Supply Voltage icut tne HET TQ Gua DR ERR dues coc 5 2 5 3 Ground Wire Resistance DC u 5 3 5 4 Leakage Current Internal Case 1 eene eene 5 4 5 5 Leakage Current External sinet snae dau nn 5 5 5 6 Patient Leakage Current Lead to Lead u 5 6 5 7 Patient Leakage Current Lead to Ground L 5 7 5 8 Leakage Current Lead to ISO incipiens areia tet edite Deae ia be decedente 5 8 APPENDIX A CIRCUIT BOARD SCHEMATIC NORTH AMERICAN VERSION A 1 APPENDIX B ERROR REPORT FORM sese B 1 APPENDIX C IMPROVEMENT SUGGESTION C 1 This page intentionally left
16. is to have the QA ST display the Mains Sup ply Voltage coming into the QA ST This is measured between Hot and Neutral 1 Press Supply V Supply Square Wave 2 The value will be displayed on the LCD The LED ON in the Measurements box will illuminate Test lead gt 3 G r ir e R e si S t a Instrument under test Test lead Power lead n e e D C The purpose of this test is to determine if there is any DC resistance between the cabinet of the Device Under Test DUT and the Mains Supply Ground on the DUT 1 Press Ground Wire Res DC QA ST will display over range 1 Ground Wire Res 2 Connect the Kelvin Test Lead to the cabinet of the DUT 3 The resistance value will be displayed on the LCD 4 4Le akage Cur rent Inter nal Case The purpose of this test is to determine if there is any leakage cur rent between DUT Ground and Mains Supply Ground Instrument under test QA ST _ aasT Safety Tartar Test lead Power lead 1 Plug in the DUT into the Outlet Supply 2 Press Leakage current Int Case Leakage Current Int Case 3 Next press Outlet Supply RS Reversed Supply The dis played QA ST value may Then press Outlet Supply OG Open The dis played QA ST value may change x Outlet Supply Instrument under test
17. ound 1 Connect all patient leads to the QA ST starting with lead 1 then lead 2 and so forth 2 Press Patient leakage current lead to GND Ground Patient leakage current leadto GND Patient leads Instrument under test QAST Tester Test lead E me lead 3 The value will be displayed on the LCD Note the value 11 12 The purpose of this test is to determine the quality of isolation be tween the DUT chassis and all of the patient leads in series Patient leads Instrument under test Test lead pee lead Connect all patient leads to the QA ST starting with lead 1 then lead 2 and so forth QA ST 1 2 Connect the Kelvin Clamp to the chassis of the DUT NOTE AII patient leads are connected internally within the QA ST to the same potential 3 Press lead ISO of ON Lead Config High Measurements J Volt lead ISO CAUTION During the lead isolation test high voltage is present at the patient lead connections While there is a resistor in the test cir cuit making the risk of dangerous shock minimal caution should be taken to avoid contact with the patient lead inputs or conductive ap plied parts during this test 4 The results will be displayed on the LCD 13 5 Calibration This chapter describes the QA ST calibration by function If you are unfamiliar with the simulators basic operation refer to paragraph 3 3 Operating Q
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