10 - Fluke
Contents
1. 4 6 4 6 Voltage Measurement Test Dual Lead eese nennen enne 4 8 4 7 Resistance Measurement Dual Lead ooooooocccnoooccnonononoconononononononnonnnnccnnnnnncononnnnnnnnnnnnnos 4 10 4 8 Connecting Auxiliary Power Source Isolating Transformer 4 11 APPENDIX A IEC 60601 1 UL 2601 1 AND VDE 0751 TESTING 1 Classification of Equipment Pee be pe E 1 2 Tests Mains Powered Class 1 amp 2 Equipment According To 60601 1 UL 2601 1 4 A 3 Tests on Internally Powered Equipment According To IEC 60601 1 UL 2601 1 13 4 System Tests Based on 60601 1 1 2601 1 0 0 15 5 Tests According To VDE 0751 10 1990 2001 0 16 111 APPENDIX B ERROR REPORT FORM 90 444 0 sosta sone tan APPENDIX SUGGESTION FORM 90 0 0 0 00 400 Manual Revision Record This record page is for recording revisions to your QA 90 User and Service Manual that have been published by METRON or its authorized representatives We recommend that only the management or facility representative authorized to process changes and revisions to publications e make the pen changes or insert the revised pages e ensure that obsolete pages are withdrawn and eit2. 3 Test VDE 0751 1 Test 3 Replacement Patient Leakage Current Ersatz Patientableit strom Applicable to Classes 1 and 2 Types BF and CF Measures replacement leakage current to mains part from all Applied Parts and enclosure in parallel Maximum leakage current Type 5000 uA For Type CF 50 uA 100 uA for CF defib paddles Not present in Class 2 INSTRUMENT UNDER TEST Applied Part INSULATING PAD This page intentionally left blank APPENDIX ERROR REPORT FORM 90 QA 90 ELECTRICAL SAFETY ANALYZER ERROR REPORT FORM USA FRANCE GERMANY NORWAY 1345 Monroe NW 30 rue Paul Claudel Gundastrasse 29 Vegamot 8 Grand Rapids MI 49505 91000 Evry France D 63762 Grossostheim N 7048 Trondheim Phone 1 888 863 8766 Phone 33 1 6078 8899 Phone 49 6026 993975 Phone 47 7395 4700 Fax 1 616 454 3350 Fax 33 1 6078 6839 Fax 49 6026 977079 Fax 47 7395 4701 E mail support metron us E mail info metron fr E mail info metron biomed de E mail support metron no METKON HA From name Address QA 90 Error Report Product Version Type Wrong results Error messages without reason Program stops no reaction Wrong responses on commands Other Description of the situation prior to the error Description of the error METRON use internally Received date Comments Critical Correction date Minor C 1 C 2 This page intentionally le
3. e QA 90 is ready to receive data 3 Prepare the PC for the upgrade e Connect an RS 232 cable between PC and QA 90 e Insert the disk that contains the QA 90 upgrade program e Write 90 DOS e Press ENTER 1 A menu will appear on the computer e Choose menu 1 SET PARAMETERS and choose new pa rameters or default values e Choose menu 2 START COMMUNICATION by pressing 2 Enter filename QA90 XXX A07 where XXX is the version of the firmware Check the file e Press ENTER 1 on the computer e Press ENTER 1 on the QA 90 and the transmission will start If the communication is successful gt gt gt gt gt gt gt will appear conti nuously at the display on the QA 90 When the program is trans mitted a normal startup menu will appear on the QA 90 The computer will either show a picture for program transmission or a clear screen 4 Check the Calibration Constants Check the calibration constants in the QA 90 through the hidden menu If necessary press 5 F6 or 7 to type your noted calibra tion constants then press ENTER 1 To store in Flash memory go back to SYSTEM SETUP SYSTEM SETUP Operator ire lt Establishment Press STORE F2 and the display will show you setup parame ters stored in flash 3 9 Cleaning the 90 The outside of the instrument may be cleaned using a damp cloth and A mild detergent Please note that solvents like Methanol may dam mage
4. Maximum leakage current 100 uA Range DC and AC up to 1 kHz Not present in Class 2 INSTRUMENT UNDER TEST L CN N L Applied Part INSULATING PAD 7 Test ENCL 2 Enclosure Leakage Current S F C Open Supply e Applicable to Classes 1 and 2 Types B BF and CF e Measures leakage current of the exposed metal parts of the instrument under test with one open supply lead interrupted S1 open normal and reversed polarity using S2 A 6 For BF and CF equipments measures with the AP GND switch 53 open and closed Maximum leakage current 500 uA Range DC and AC up to kHz Not present in Class 2 INSTRUMENT UNDER TEST L N O P Applied Part INSULATING PAD 8 Test ENCL 3 Enclosure Leakage Current S F C Open Earth Ground Applicable to Class 1 Types B BF and CF Measures leakage current of the exposed metal parts of the instrument under test with Protec tive Earth open circuit S4 open normal and reversed polarity using 52 For Type BF and CF equipments measures with the AP GND switch S3 open and closed Maximum leakage current 500 uA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST L N N f p N L Applied Part INSULATING PAD 9 Test P L C 1 Patient Leakage Current Normal Condition Applicable to Classes 1 and 2 Types B BF and CF Measures patient leakage current to eart
5. T Nor of leads ivive lt 5 AA A 4 4 Power Cable Test The earth lead in the power cable is tested as follows Plug the power cable into the front panel of the QA 90 then connect a calibrated test A lead between ENCL and the each pin on the power cable Test Lead NOTE Ensure that the test leads are calibrated BEFORE the test 1 Press MORE F1 in MAIN MENU 2 Press Test Mode F5 and select Manual 3 Press START F4 4 Press MORE F1 in MANUAL TEST SETUP 5 Press Protective Earth F7 6 Press START F1 Equipment Code aai Sequence Name Vai lt Class CL1 0 leads 0 modules gt Test according to TEC60601 1 Test Type R lt p Test Mode Automatic 4 5 MANUAL TEST SETUP Mains Voltage Current Consumption Seconds Result Limit 4 5 Current Measurement Test Dual Lead This test measures leakage current from one instrument to another in strument Instrument Instrument under test under test 1 Press MORE F1 in MAIN MENU 2 Press Test Mode F5 and select Manual 3 Press START F4 4 Press MORE F1 in MANUAL TEST SETUP 4 6 5 Press MORE Fl three more times 6 Press Current Measurement Dual Lead F7 7 Press START F1 Equipment Code Sequence Name Wied Class CL1 0 leads in 0 modules gt Test according to IEC60601 1 Test Type Test Mode Automatic Current Measurement Dual Lead Volta
6. open normal and reversed polarity using S2 e AP switch is used to obtain all AP combinations e Maximum auxiliary current Types B and 50 pA DC 500 uA Range AC 0 1 Hz up to 1 kHz For CF 50 uA Range DC and AC up to 1 kHz 9 Not present in Class 2 INSTRUMENT UNDER TEST L N e MD N L 7 Applied Part PA1 INSULATING PAD 5 PA4 PA3 PA2 15 Test P A C 3 Patient Auxiliary Current S F C Open Earth Ground e Applicable to Class 1 Types BF and CF e Measures the current flowing between one of the Applied Parts and all of the others in parallel with the Protective Earth open circuit S4 2 open normal and reversed polarity using S2 e AP switch is used to obtain all AP combinations e Maximum auxiliary current Types B and BF 50 uA DC 500 uA Range AC 0 1 Hz up to 1 kHz For Type CF 50 uA Range DC and AC up to 1 kHz Not present in Class 2 INSTRUMENT UNDER TEST L N o P MD 51 O O N D Low Applied Part 54 9 4 5 PA4 PA3 PA2 Tests on Internally Powered Equipment According To IEC 60601 1 UL 2601 1 1 Test LP 1 Enclosure Leakage Current Normal Condition e Applicable to internally powered equipment Types B BF and e Measures leakage current of the exposed metal parts of the instrument under test e For Type BF and CF equipments measures with the A
7. 2 1 2 1 Receipt Inspection and 2 1 22 2 2 2 3 TN 2 2 2 4 PRO SO dirt a eres oda dd 2 2 3 OPERATING QA 90 c STES ieaS 3 1 3 1 Control Switches and Connections essere enne tnn seen entre 3 1 3 2 Key Pad FEunctions eee oe e DRE Het dps 3 3 3 3 Function of The Bar Code Reader cccccccccccccssssscececececsenseaececececeesnaeceeececeesseeeeeceeeeneas 3 3 3 4 Menu and Function Keys eto ettet pe REIR eve EE ERE SEI elena de 3 4 3 5 Display Menus and Messages eese eene nennen 3 4 3 6 Measurements with Several Modules in Manual 3 0 3 7 Storing Setup Parameters in Flash Memory eese nennen 3 10 3 8 Upgrading the QA 90 Software 2 3 11 3 9 Cleaning the QA Oil e reete e epe ne ee etes 3 14 4 EXAMPLE TEST MEASUREMENTS eese eee ee ee ee ee sese setas eee 4 1 41 Test 0 ERO 4 1 4 2 Connecting an Instrument without Patient Inputs essen 4 2 4 3 Connecting an Instrument with Patient 4 3 4 4 A 4 5 4 5 Current Measurement Test Dual
8. METRON will for a period of twelve 12 months from date of purchase replace or repair any defective analyzer if the fault is due to a manufacturing defect In no event will METRON or its local representatives be liable for direct indirect special incidental or consequential damages arising out of the use of or inability to use the QA 90 Electrical Safe ty Analyzer even if advised of the possibility of such damages METRON or its local representatives are not re sponsible for any costs loss of profits loss of data or claims by third parties due to use of or inability to use the QA 90 Electrical Safety Analyzer Neither METRON nor its local representatives will accept nor be bound by any other form of guarantee concerning the QA 90 Electrical Safety Analyzer other than this guarantee Some jurisdic tions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you ii Table of Contents MANUAL REVISION RECORD sesccssscsssessessnsscosssssnnsvssassesesenscssanssbecscennicndeesseasseveasentessesesseaveanssssensooses V 1 bep r rnes can oe Ehe een ee ense eoe Ten de roe 1 1 1 1 QA 90 Features Ue Rest as 1 1 1 2 Si 1 1 1 3 General Information ieu scere erem ede e UB ceu e prete tpe ee eee PO es 1 3 2 APA
9. messages test results and function menus 3 1 4 Patient Leads For connecting patient inputs Caution 256 Max 500 VDC can be present during specified tests 5 Dual and E floating inputs outputs These function in the manner of standard multimeter leads 6 Enclosure for connecting to the casing of the instrument un der test 7 Earth Extra earth connection for calibrating measuring leads 8 Contact For connecting the power plug of the instrument to be tested Rear Panel Auxiliary Power 100 240VAC to Equipment 47 63Hz under Test Fused 716A 250VAC On Warning Power Attention 13 technique qualifie 3 Mains QA 90 nen 100 240VAC 47 63Hz Fused 16 250VAC 9 Power Switch 10 RS 232 Serial Port 11 Bar Code Port 12 Printer Outlet Port 13 Mains QA 90 14 Auxiliary Power 15 Fuse 16 Earthing Contact 3 2 Turns power ON and OFF 9 pin D sub 9 pin D sub HP Smartwand Interface TTL 25 pin D sub Centronic output Mains connection for test instrument Auxiliary power connection for instrument under test Mains fuses 2 x 16 Amps 220V Extra earthing point 3 2 Key Pad Functions The alphanumeric keys comprise both numbers and letters Hold the key in and it moves automatically from character to character Patient Leads Backspace 3 3 Function of The Bar Code Reader The bar code reader may be used in th
10. AP combinations Maximum auxiliary current Types and BF 10 uA DC 100 uA Range AC 0 1 Hz up to 1 kHz Maximum auxiliary current Type CF 10 yA Range DC and AC up to 1 kHz MD MD INSTRUMENT UNDER TEST 2 5 PA4 A 4 System Tests Based on IEC 60601 1 UL 2601 1 1 Test SYS 1 Enclosure Leakage Current Normal Condition Applicable to Classes 1 and 2 Types B BF and CF Measures leakage current of the exposed metal parts of the instrument under test and between parts of the system within the patient environment normal and reversed polarity using S2 Maximum leakage current 100 uA Range DC and AC up to kHz MEDICAL ELECTRICAL SYSTEM Not present in Class 2 Can be multiple different connections to INSTRUMENT UNDER TEST different equipment at the same time Signal part e Signal part L and or output output 070 N 52 51 INSTRUMENT e m ND d 54 MD Applied Part 2 Test SYS 2 Enclosure Leakage Current S F C Open Earth Ground Can be multiple different connections to different equipment at the same time INSTRUMENT UNDER TEST Signal part o Signal part LN output output 004 N 52 OTHER 51 INSTRUMENT O 0 0 o N D 54 MD Applied Part Applicable to
11. Class 1 Types B BF and CF Measures leakage current of the exposed metal parts of the instrument under test with Protec tive Earth open circuit S4 open and between parts of the system within the patient envi ronment normal and reversed polarity using S2 Maximum leakage current 500 uA Range DC and AC up to kHz MEDICAL ELECTRICAL SYSTEM A 15 A 5 Tests According To VDE 0751 10 1990 2001 1 Test VDE 0751 1 Test 1 Replacement Leakage Current Fig 9 Ersatz Ableitstrom nach Bild 9 e Applicable to Classes 1 and 2 Types B BF and CF For Class 1 Protective Earth conductor is not connected e Measures replacement leakage current to earth from all Applied Parts and enclosure in paral lel normal and reversed polarity using S e Maximum leakage current 1000 uA Range DC and AC up to 1 kHz AC Power Connected INSTRUMENT UNDER TEST Applied Part INSULATING PAD 25 Ei MD Not present in Class 2 2 Test VDE 0751 1 Test 2 Replacement Equipment Leakage Current Ersatz Ger teableit strom e Applicable to Class 1 Types B BF and CF e Measures replacement leakage current to mains part from all Applied Parts and enclosure in parallel with Protective Earth wire connected e Maximum leakage current 1000 uA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST Applied Part PE ES INSULATING PAD
12. Leakage Current S F C Mains on Applied Part e Applicable to Classes 1 and 2 Types BF and e Measures leakage current to earth from Applied Part to earth caused by external mains voltage on Applied Part and with switch 55 open and closed e Each polarity combination possible is tested using 55 and 56 Maximum leakage current Type BF 5000 uA Range DC and AC up to 1 kHz For Type CF 50 uA Range DC and AC up to 1 kHz 100 uA for CF defib paddles IEC 601 2 4 Not present in Class 2 INSTRUMENT UNDER TEST Signal part in and or output INSULATING PAD 13 Test P A C 1 Patient Auxiliary Current Normal Condition e Applicable to Classes 1 and 2 Types B BF and CF A 9 Measures the current flowing between one of the Applied Parts and all of the others paral lel e g patient leads normal and reversed polarity using S2 AP switch is used to obtain all AP combinations Maximum auxiliary current Types and BF 10 yA DC 100 Range AC 0 1 Hz up to 1 kHz For Type 10 uA Range DC and up to 1 kHz Not present in Class 2 INSTRUMENT UNDER TEST L N o MD N L Applied Part PA1 14 Test P A C 2 Patient Auxiliary Current S F C Open Supply e Applicable to Classes 1 and 2 Types B BF and CF e Measures the current flowing between one of the Applied Parts and all of the others in parallel with one supply lead interrupted S1
13. Measurement Dual Lead lt Resistance Measurement Dual Lead Open Supply Result lt p Measure between E and E inputs 4 8 Connecting Auxiliary Power Source Isolat ing Transformer External power cable gives power out on the contact on the front pan A el to the instrument under test NOTE The QA 90 power cable must also be connected Mains QA 90 100 240 VAC N For connections of Variac or Isolating transformers 4 12 If the equipment under test is to be tested for voltages and or frequen cies that differs from the nominal mains supply the test voltage must be connected to the auxiliary inlet To route the auxiliary power to the contact on the front panel the procedure below must be executed 1 Be d c Press SETUP F3 in MAIN MENU Press MORE F1 in SYSTEM SETUP Press MORE F1 three more times Press External Isolating Transformer F7 and select Y Yes Equipment Code En Sequence Name x lt Class CL1 0 leads 0 modules gt SYSTEM SETUP Operator d Ci lt l Establishment Acoustic alarm for failed test External Isolating Transformer ses lt Auxiliary Power This page intentionally left blank 4 13 4 14 This page intentionally left blank APPENDIX IEC 60601 1 UL 2601 1 AND VDE 0751 TESTING This appendix describes International Electrotechnical Committee IEC Standard 60601 1 Underwri ters Laboratories UL St
14. N MENU Equipment Code Sequence Name T lt Class CL1 0 leads 0 modules gt 3 9 Fl F2 F3 F4 2 Press Test Mode F5 and select Manual Press START F4 Test according to EC60601 1 Test Type i Rapid 22224 lt Test Mode Manual 3 Press MORE F1 in repeatedly until you find the desired mea surement e g Mains on applied part 5 MANUAL TEST SETUP Mains Voltage lt Current Consumption 4 Press PL on the keypad to obtain the recording window for Module Code and No of leads Module Code No of leads 5 Select which Module Code to be measured with NEXT F4 or Prev F3 Press GO BACK F2 Press START F1 to start the test Press STOP F1 to stop the test een a To select a new module press PL and repeat the same procedure 3 7 Storing Setup Parame ters in Flash Memory The following parameters can be stored in Flash memory e Operator e Establishment e Serial Number e Language e Calibration parameters To store the setup parameters in Flash memory go to SETUP F3 in MAIN MENU Equipment Code Sequence Name ay lt p Class CL1 0 leads in 0 modules gt Press STORE F2 in SYSTEM SETUP and the display will show you the setup parameters stored in flash SYSTEM SETUP Operator Dm lt Establishment 3 8 Upgrading the QA 90 Software Program For installing software version 2 00 or high
15. P GND switch 53 open and closed Maximum leakage current 100 uA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST T Applied Part MD INSULATING PAD o MMMM A Y S3 2 Test LP 2 Patient Leakage Current Normal Condition e Applicable to internally powered equipment Types B BF and CF e Measures the patient leakage current from the Applied Parts to the enclosure e For Type BF and CF equipments measures with the AP GND switch 53 open and closed e Maximum auxiliary current Types B and BF 100 uA Range DC and AC up to kHz For Type CF 10 uA Range DC and AC up to kHz INSTRUMENT UNDER TEST 3 Test I P 3 Patient Leakage Current S F C Mains on Applied Part Applicable to internally powered equipment Types BF and CF Measures the patient leakage current from the Applied Parts to the enclosure caused by the ex ternal mains voltage on the Applied Part Maximum auxiliary current Type BF 500 uA Range DC and AC up to 1 kHz Maximum auxiliary current Type CF 50 uA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST 6 Applied Part Signal part in and or output Test LP 4 Patient Auxiliary Current Normal Condition Applicable to internally powered equipment Types B BF and CF Measures the current flowing from one of the Applied Parts and all the others in parallel AP switch is used to obtain all
16. QA 90 User Manual QA 90 Electrical Safety Analyzer METR N HA P N 11025 V 3 47 3 Copyright O 2004 by METRON All rights reserved METRON USA 1345 Monroe NW Grand Rapids MI 49505 Phone 1 888 863 8766 FRANCE 30 rue Paul Claudel 91000 Evry France Phone 33 1 6078 8899 GERMANY Gundastrasse 29 D 63762 Grossostheim Phone 49 6026 993975 NORWAY_____ Vegamot 8 N 7048 Trondheim Phone 47 7395 4700 Fax 1 616 454 3350 Fax 33 1 6078 6839 Fax 49 6026 977079 Fax 47 7395 4701 E mail support metron us E mail info metron fr E mail info metron biomed de E mail support metron no Disclaimer METRON provides this publication as is without warranty of any kind either express or implied including 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 jurisdic tions do not allow disclaimers of expressed or implied warranties in certain transactions therefore this statement may not apply to you Limited Warranty METRON warrants that the QA 90 Electrical Safety Analyzer will substantially conform to published specifi cations and to the documentation provided that it is used for the purpose for which it was designed
17. Safety Tests Power Supply Tests Classes 1 and 2 Enclosure Tests Applied Parts Tests Types B BF and CF Systems Tests TO SYSTEM 10V 10 uA ENCLOSURE A 3 A 2 Tests Mains Powered Class 1 2 Equipment According To IEC 60601 1 UL 2601 1 1 Test P E 1 Protective Earth Continuity e Applicable to Class 1 Types B BF and CF e Measures impedance of Protective Earth Terminal to all exposed parts of the instrument under test which are connected to the Protective Earth e Normally includes the wiring in the mains cable maximum 0 2 Ohms Without the mains ca ble the maximum is 0 1 Ohms e Test current 25 Amps applied for a minimum of five seconds Ifequipotential connection present measure also with yellow green E P conductor connected INSTRUMENT UNDER TEST Applied Part INSULATING PAD 2 Test LR 1 Insulation Resistance Mains Part to Case 50 Hz e Applicable to Class 1 Types B BF and e Measures insulation resistance of power leads live and neutral wires together to the Protec tive Earth terminal of the instrument under test e Minimum 2 0 MOhms INSTRUMENT UNDER TEST 500V DC Applied Part INSULATING PAD 3 Test LR 2 Insulation Resistance Applied Part to Case e Applicable to Class 1 Types and CF e Measures insulation resistance between the Applied Part to the Protective Earth terminal of the instrumen
18. alibrated test lead be NOTES tween the ENCL connector on the front panel of the QA 90 and the Ensure that the mains A E switch on the instrument to casing of the instrument to be tested Following that connect patient be tested is switched ON lead between the instrument to be tested and Patient leads on the QA 90 See below Test Lead Instrument under test Patient Lead 4 3 4 4 UN E gt Press Equipment Classification F6 and select classifica tion Press MORE F1 Press Test according to F7 and select test standard Press Test Type F6 and select either Rapid or Normal Press Test Mode F5 and select either Automatic or Ma nual Press PL on the keypad to obtain the recording window for patient lead Press Module Code F7 if you wish to record the name of a new module Press ENTER 1 Press No of leads F6 to enter the number of leads Press ENTER 1 Press Type F5 to select protective class Press ADD F1 to accept The number of modules stored will be shown in parenthesis in the Module Code line Repeat as required to enter a new patient module Press GO BACK F2 to return to the menu Press START F4 in the MAIN MENU to start the test Equipment Code p Sequence Name lt Class CL1 0 leads 0 modules gt Test according to EC60601 1 Test Test Mode Manual Module Code
19. andard 2601 1 and Verband Deutscher Elektrotechniker e V VDE 0751 Standard tests their functions applicability and equipment connections A 1 Classification of Equipment Electrical safety begins with considering the mains electricity supply and how to feed that into an item of equipment so that it is able to power the electronics internally and at the same time ensure that there is no possibility of the mains power coming into contact with either the patient user or a third person The classification of equipment under IEC 601 1 and UL 2601 1 describe how the mains part insulation is achieved The techniques used include air clearance insulating materials basic or functional insula tion creepage distances and double insulation 1 Class 0 The mains part is completely separated from any of the accessible parts The separation is achieved by basic insulation This is not used in medical applications MAINS Basic insulation 2 Class 1 In addition to the basic insulation there is protection via the protective earth conductor in the mains lead This is intended to connect all the equipment s accessible parts to earth The major ity of electromedical equipment is Class 1 equipment MAINS Protective Earth Conductor Basic insulation 3 Class 2 Equipment of this class is constructed with double insulation i e two distinct insulating layers around the mains part The purpose is that should the basic ins
20. bel describe what is wrong with the instrument and provide the model and serial numbers If possible use the original packaging material for return shipping Otherwise repack the unit using e cardboard box strong enough to carry the weight of the unit e atleast 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 5 or its representative 2 1 2 2 Setup A NOTE Some RS 232C cables are missing the connection between the se venth and the eighth wires in the cable The cable may still be called NULL modem but it will not work with the QA 90 Refer to the ansur or PRO Soft QA 90 Users Manual for more information 2 3 Power 2 4 Ansur amp PRO Soft 2 2 1 Equipment connection is as shown in the typical setup below At tach the printer cable to the 25 pin outlet port Printer Cable 90_ IAR VERSION XKE DRTEDU Vs 2 If ansur or PRO Soft is being used attach an RS 232C null modem data t
21. ched on METRON QA 90 Boot software version X XX AAAA METRON QA 90 Version Date DD MM YYYY METRON QA 90 Electrical Safety Analyzer TOTAL MEMORY 114688 3 4 2 Main Menu Equipment Code ua Sequence Name Mss lt Class CL1 0 leads 0 modules gt 3 MORE F1 When MORE F1 is pressed the following dis play will appear Test according to EC60601 1 Test Type 5 ovato lt Test Mode Automatic BACK This window offers the following functions Press Test according to F7 to select either 60601 1 IEC 60601 2 4 IEC 61010 1 UL 2601 1 IEC61010 AS 3200 1 HEI 95 DB 9801 ANSI AAMI VDE 0751 10 1990 or VDE 0751 10 2001 Standards e Press Test Type to select either Rapid or Normal test type Press Test Mode 5 to choose between Automatic Manual test e GO BACK F2 to return to the previous display Press START F4 to start the test 4 MEMORY F2 QA 90 s memory is divided into two parts tests and sequences If you have several equivalent instruments to test you can define one test sequence for all the instruments and store it as a sequence You use this sequence to test all the instruments and store each of the test results with the instrument s respective equipment code The functions in the MEMORY menus enable you to store re trieve transfer print and delete test results and s
22. e main menu and in the patient lead to record respectively the instrument code and class module code number of leads and type The program will select the correct screen display depending on the bar code format The program will give a beep if a wrong format is read INSTRUMENT CODE FORMAT FIELD DESC VALUE ACCEPTED MAX CHARACTERS Instrument code alphanumeric 20 Separator 1 must be included Instrument class CLI CL2 I P 3 must be included Example abcdefg CL2 Instrument code abcdefg Instrument class CL2 PATIENT LEAD FORMAT FIELD DESC VALUE ACCEPTED MAX CHARACTERS Module code alphanumeric 20 Separator 1 must be included No of leads numeric 0 99 2 Separator 1 must be included Type BF CF B 2 must be included Example mnopqrst 2 Module code mnopqrst Number of leads 2 Module type B 3 3 3 4 Menu and Function Keys The QA 90 uses displays function keys and a keypad to provide flex 1bility and control over operations The top three lines in the display are used for messages status and results The menu bar is shown at the bottom of the display Function keys numbered from Fl to F7 A function menu is selected by pressing that key which is directly be low to the right of the menu unit shown in the display 3 5 Display Menus and Messages 1 Startup Screen The following screens will be displayed in se quence for the first 10 seconds after the QA 90 has been swit
23. en the test is complete Test lead enclosure grnd XXX mOhm Test lead dual float XXX mOhm lt 4 2 Connecting an In strument without Pa tient Inputs Connect the mains plug of the instrument to be tested to the QA 90 s terminal on the front panel Then connect a calibrated test lead be tween the ENCL connector on the front panel of the QA 90 and the NOTES casing of the instrument to be tested See below Ensure that the mains switch Test Lead Instrument on the instrument to be under test tested is switched ON message REVERSED POLARITY is shown in the MAIN MENU reverse the mains plug Power Lead oco0c00 lo 1 Press Equipment Classification F6 and select classifica tion 4 2 Press MORE F1 Press Test according to F7 and select test standard Press Test Type F6 and select either Rapid or Normal Press Test Mode 5 and select either Automatic or manual Press START F4 to start the test RE AAN Equipment Code sw Sequence Name Sear lt Class CL1 0 leads 0 modules gt Test according to TEC60601 1 Test Type 4 lt Test Mode Automatic 4 3 Connecting an In strument with Patient Inputs This includes IEC Classifications Body B Body Float BF and A Cardiac Float CF Connect the mains plug of the instrument to be tested to the QA 90 s terminal on the front panel Then connect a c
24. equences from the memory The four main memory displays are as follows 3 5 3 6 Equipment Code Store test in memory Display test results Equipment Code Recall and transfer test from memory Recall and print test from memory Transfer all tests from memory List test in memory to printer Print all tests in memory Equipment Code Delete test in memory Delete all tests in memory The F5 and F6 function keys generate new displays as confirma tion of an executed function or error message e Press GO BACK F2 to return to the previous display e Press MAIN MENU F4 to start the test The three main sequence displays are shown below Sequence name Store seq memory 6 Print sequence List all sequences in memory Print all sequences in memory lt Sequence name Delete sequence memory 6 Delete all sequences in memory SETUP F3 This function is used for entering general information in connec tion with the test Seven main displays are shown below SYSTEM SETUP Operator Var lt q Establishment QA 90 Serial no 7 1T Net lt Power up delay time QA 90 Serial no IT Net lt Power up delay time 3 7 3 8 Stop at new power config Stop before new power config Stop at new module Multiple Protective Earth Tests Multiple Enclosure Tests PE Test Current External Isolating Transformer Acoustic alarm for failed test Auxiliary Powe
25. er use the following pro cedure 1 Preparation IMPORTANT e Turn on the unit When upgrading the software calibrated units you should note e Press SETUP F3 from the Main menu Equipment Code Sequence Name lt Class CL1 0 leads 0 modules gt the calibration constants in the unit There are seven constants that can be read on the unit dis play 3 11 Press CAL from the System Setup SYSTEM SETUP Operator Establishment e Then go to the hidden menu under F1 in the menu for Self Calibration SELF CALIBRATION Calibrate test lead enclosure earth gt Calibrate test lead dual float e Note the values on the three constants that appear on the dis play e Press MORE F1 to get the three next constants e Press MORE F1 to get the last constant NB Automatic MAP calibration ONLY for production calibration The QA 90 software upgrade contains two files comqa90 exe the communication between computer and the QA 90 and qa90 xxx a07 is the program for QA 90 XXX indicates the version of the firmware Prepare the QA 90 for the software upgrade e Reading the program to Flash memory in the QA 90 e Press and hold PL and CLR at the same time while turning the QA 90 on e The display will show the following The software in the QA 90 is missing To download new software run COMMQA90 on the PC and press ENTER on QA 90
26. ests Multiple In one test run a maximum of 11 modules with different protection classes may be tested Accuracy Range 1 0 100 pA Resolution 1pA Accuracy 2 of full scale 1 LSD Range 2 100 1000 pA Resolution 1 pA Accuracy 2 of full scale 1 LSD Range 3 1 0 10 0 mA Resolution 1 pA Accuracy 1 of full scale 1 LSD Frequency Response DC 1 MHz 3dB with a crest factor of gt 2 The applied test voltage for patient leakage current is 110 of the line vol tage delivered through a limiting resistor of 47 kOhm Temperature Requirements 15 C to 35 C when operating 0 C to 50 C in storage Display Type LCD graphic display Alphanumeric format 4 lines 40 characters Data Input Output 2 Parallel printer port 1 Bi directional RS 232C 1 for computer control Power From 110 VAC to 240 VAC 47 63 Hz 3900 VA Do not exceed 16 Amps of current at any voltage within the operating range Installation Category II Fuses Two 16 Amp 250V slow blow fuses 1 3 1 4 Mechanical Specifications Housing Metal case Height 13 2cm Width 34 2 Depth 30 5 cm Weight 5 8 kg Standard Accessories User and Service Manual QA 90 Additional Accessories Carrying Case Carrying case ext printer Bar Code Reader Isolating transformer 400VA Isolating transformer 800VA Test unit ESA E input measuring cable 2m E input measuring cable 5m Clamp crocodile type PRO Soft QA 90 software PRO Soft QA 90 DEMO User Serv
27. ft blank APPENDIX SUGGESTION FORM QA 90 QA 90 ELECTRICAL SAFETY ANALYZER SUGGESTION FORM USA FRANCE GERMANY NORWAY 1345 Monroe NW 30 rue Paul Claudel Gundastrasse 29 Vegamot 8 Grand Rapids MI 49505 91000 Evry France D 63762 Grossostheim N 7048 Trondheim Phone 1 888 863 8766 Phone 33 1 6078 8899 Phone 49 6026 993975 Phone 47 7395 4700 Fax 1 616 454 3350 Fax 33 1 6078 6839 Fax 49 6026 977079 Fax 47 7395 4701 E mail support metron us E mail info metron fr E mail info metron biomed de E mail support metron no METKON From name Address QA 90 Improvement Suggestion Product Version Type One window Presentation Several windows Options configuration possibilities Documentation Other Description of the suggested improvement METRON use internally Received date Comments Correction date D 2
28. ge Measurement Dual Lead Resistance Measurement Dual Lead Open Supply Result Measure between E and E inputs 4 7 4 6 Voltage Measurement 4 8 Test Dual Lead Measuring voltage potentials to a specified reference Instrument under test 1 Press MORE F1 in MAIN MENU Press Test Mode 5 and select Manual Press START F4 Press MORE F1 in MANUAL TEST SETUP Press MORE F1 three more times Press Voltage Measurement Dual Lead F6 Press START F1 Equipment Code PM Sequence Name lt Class CL1 0 leads 0 modules gt OY E Test according to Test Type lt Test Mode 4 9 Current Measurement Dual Lead Voltage Measurement Dual Lead lt Resistance Measurement Dual Lead Voltage V 1 6 Measure between E E inputs 4 7 Resistance Measure ment Dual Lead Measuring protective earth on fixed installations QA 90 fe e eee eeeoeoej 1 Press MORE F1 in MAIN MENU 2 Press Test Mode F5 and select Manual 3 Press START F4 4 Press MORE F1 in MANUAL TEST SETUP 5 Press MORE F1 three more times 6 Press Resistance Measurement Dual Lead F5 7 Press START Equipment Code sul Sequence Name he lt Class CL1 0 leads 0 modules gt 4 10 Test according to TEC60601 1 Test Type lt Test Mode Automatic Current Measurement Dual Lead Voltage
29. h from all Applied Parts in parallel normal and re versed polarity using S2 Maximum leakage current Types and 100 yA Range DC and up to 1 kHz For Type CF 10 uA Range DC and AC up to 1 kH2 A 7 9 Not present Class 2 INSTRUMENT UNDER TEST L N o 2 N L Applied Part INSULATING PAD MD 10 Test P L C 2 Patient Leakage Current S F C Open Supply e Applicable to Classes 1 and 2 Types BF and e Measures patient leakage current to earth from all Applied Parts in parallel with one supply lead interrupted 51 open normal and reversed polarity using 52 e Maximum leakage current Types and 500 uA Range DC and AC up to 1 kHz For Type CF 50 uA Range DC and AC up to 1 kHz Not present in Class 2 INSTRUMENT UNDER TEST L iN o N L Applied Part INSULATING PAD E MD 11 Test P L C 3 Patient Leakage Current S F C Open Earth e Applicable to Class 1 Types B BF and CF e Measures leakage current to earth from all Applied Parts in parallel with the Protective Earth open circuit S4 open normal and reversed polarity using S2 e Maximum leakage current Types B and BF 500 uA Range DC and AC up to 1 kHz For Type CF 50 uA Range DC and AC up to 1 kHz A 8 INSTRUMENT UNDER TEST LN N L Applied Part INSULATING PAD MD 12 Test P L C 4 Patient
30. her disposed of immediately or marked as su perseded 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 Initial Release 3 47 2 07 27 06 Change of Spec Voltage Hans Ove Kristiansen FBE Measurement BW 1 kHz Symbols Used This Manual Caution Refer to accompanying documents See NOTE Caution Risk of Electrical Shock see NOTE Earth ground TERMINAL vi 1 1 QA 90 Features 1 2 Specifications 1 Introduction This chapter describes the QA 90 Electrical Safety Tester s features and specifications The QA 90 represents a new generation of safety testing equipment It 1s the only automatic safety analyzer that can test units with different classes of protection in one test run e g cardiac float and body float defibrillators It is simple to use All you need do is select the type and class of equipment to test When you press START QA 90 ex ecutes the tests prescribed to the selected standard Test results may be printed out immediately or stored internally in the unit for later use QA 90 has full remote control and may be operated from PRO Soft QA 90 software PRO Soft QA 90 enables you to make your own test protocols store the information on disk and ex port formatted data to any other database or equipment management program I
31. ice Manual PRO Soft QA 90 Storage 3 9 in 9 8 in 11 0 in 4 1 lbs P N 11025 2 gt 11100 10500 11400 11401 11410 11402 11411 11415 11412 11200 11201 11225 C X CUCU 25522525550 ZZZZZZZZ 95 222 Store in the carrying case in dry surroundings within the tem perature range specified There are no other storage require ments Periodic Inspection The unit should be calibrated every 12 months 2 1 Receipt Inspection and Return 2 Installation This chapter explains unpacking receipt inspection and claims and the general procedures for initial QA 90 setup Example test setup procedures are contained in Chapter 4 Example Test Measurements 1 Inspect the outer box for damage 2 Carefully unpack all items from the box and check to see that you have the following items QA 90 Electrical Safety Tester 11200 e QA 90 User and Service Manual 11025 3 If you note physical damage or if the unit fails to function ac cording to specification inform the supplier immediately When METRON AS or the company s representative is informed measures will be taken to either repair the unit or dispatch a re placement The customer will not have to wait for a claim to be investigated by the supplier The customer should place a new purchase order to ensure delivery 4 When returning an instrument to METRON AS or the company representative fill out the address la
32. ipment being tested at your facility Templates can include checklists written procedure and equipment data in the form of a test Protocol The equipment data can be entered manually into the protocol or it may be retrieved by ansur or PRO Soft from a database program or other equipment files Protocols can be created easily for each item of equipment in your inventory and stored for use Test protocols with results can be printed or stored on disk and the results of testing can be sent back to the equipment database to close a work order and update the service history 2 3 2 4 This page intentionally left blank 3 Operating QA 90 This chapter explains the operating controls switches and menus of the QA 90 details how to use them in testing and provides general information on printouts and operator maintenance 3 1 Control Switches and Connections Front Panel QA 90 Safety Analyzer 1 11 alphanumeric keys used to enter information Patient Leads New window for recording patient inputs Clear Clears the whole display Return Deletes the last character 2 Enter Records entered data 2 Function Keys F1 F4 are used to select the functions shown in the menu bar at the bottom of the display for selecting the function that is directly above the key F5 F7 are used to select the func tion or enter information in the message field in the same line 3 LCD Display Shows
33. ndividual test sequences may be compiled to satisfy na tional and international standards The following standards may be compiled either fully or in part 60601 1 UL 2601 1 IEC 60601 1 1 UL 2601 1 1 60601 2 4 IEC 61010 1 EN 60601 1 VDE 0750 12 91 BS 5724 CAN CSA C22 2 No 601 1 M90 AS 3200 1 NZS 6150 1990 VDE 0751 1 10 1990 VDE 0751 1 10 2001 OVE 0751 UL 544 HEI 95 HEI 158 among others 1 Voltage Measurement Measurements may be obtained in the following ways Between leads 1 and 2 in the power contact Between lead 1 and ground in the power contact Between lead 2 and ground the power contact Between input output E and E floating inputs outputs Range 0 400V true RMS Resolution 0 1V Accuracy DC 100 Hz 1 of full scale 1 LSD 100 Hz 1 kHz 2 of scale 1 LSD No of Tests 4 or multiple LSD least significant digit 1 1 2 Current Consumption The current measurement may be executed in lead no 1 live Range 1 0 1000 mA RMS lt 250VAC Resolution 1 mA Accuracy 2 of full scale 1 LSD No of Tests 1 or multiple Range 2 1 16 RMS O lt 250VAC Resolution 1 mA Accuracy 1 of full scale 1 LSD No of Tests 1 or multiple Protective Earth The test current is selectable from 25A 1A delivered from a transformer with a maximum idle voltage of 6V The measurement can be performed on ground leads or between E and E floating inputs ou
34. r Language English Date XX XX XXXX DD MM YYYY gt Time XX XX XX HH MM SS Report page length of lines 58 FIRMWARE Ver XX XX Recording and Storing Patient Modules and Patient Leads e Press PL on the keypad to obtain the window for recording patient modules and leads Module Code No of leads Type 3 6 Measurements with Several Modules in Manual Mode Fl F2 FA Go to the next patient module stored Go to the previous patient module stored Return to the previous menu Press ADD F1 to save in the memory Press Module Code F7 to record the code name of a new patient module Press ENTER 1 Press No of leads F6 to enter the number of patient leads Press ENTER 1 Press Type F5 to select protective class B BF CF Press ADD F1 to save in the memory The number of mod ules stored will be shown in parenthesis in the Module Code line Repeat the above guidelines to enter the next module Press NEXT F4 to go to the next patient module stored Press PREV F3 to go to the previous patient module stored Press GO BACK F2 to return to the previous menu 7 START F4 This function starts the test sequence Manual or automatic test sequences are selected under MORE F1 in MAIN MENU When you perform measurements on several modules in Manual Mode and want to select which module to measure use the following procedure 1 Press MORE F1 in MAI
35. ransfer configured cable to the 9 pin D sub outlet port located at the rear of the QA 90 Do not attach the printer cable to the QA 90 See below Printer Main On Off Switch QA 90 should remain off for at least 5 seconds before switching on again in order to allow the test circuits to discharge fully Ansur and PRO Soft are front end test automation and presentation tools for METRON s QA 90 Electrical Safety Analyzer It allows you to conduct the same tests but by remote control via an computer run Ansur and PRO Soft has its own user manual which contains all the information concerning the program If you order a demon stration version of the program you also receive the manual ning Windows 98 2000 or XP Additionally the program has addi tional features to automate and enhance your electrical safety testing Each of the QA 90 tests can be run independently from ansur or PRO Soft in the Manual test mode Results are shown on the PC screen during testing and the user is prompted to set the tested equipment accordingly At the conclusion of tests the user may print a report store the test and results on disk or both Combinations of tests can be created and stored as Test Template The program maintains a library of these templates In this way you can store and retrieve templates that are appropriate for each kind of equ
36. t under test Minimum 10 0 MOhms INSTRUMENT UNDER TEST Applied Part INSULATING PAD 4 Test E L C 1 Earth Leakage Current Normal Condition e Applicable to Class 1 Types B BF and CF e Measures earth leakage current of the instrument under test connected to the mains power supply normal and reversed polarity using S2 e For Type BF and CF equipments measures with the AP GND switch 53 open and closed e Maximum leakage current 500 uA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST LN N o N L Applied Part INSULATING PAD 5 Test E L C 2 Earth Leakage Current S F C Open Supply e Applicable to Class 1 Types B BF and CF A 5 e Measures earth leakage current of the instrument under test with one open supply lead inter rupted S1 open normal and reversed polarity using S2 e For Type BF and CF equipments measures with the AP GND switch 53 open and closed e Maximum leakage current 1000 HA Range DC and AC up to 1 kHz INSTRUMENT UNDER TEST LN N p N L Applied Part INSULATING PAD 6 Test ENCL 1 Enclosure Leakage Current Normal Condition e Applicable to Classes 1 and 2 Types B BF and CF e Measures leakage current of the exposed metal parts of the instrument under test normal and reversed polarity using 52 e For Type BF and CF equipments measures with the AP GND switch 53 open and closed
37. the overlay and cabinet This page intentionally left blank 4 1 Test Lead Calibration A 4 Example Test Measurements This chapter contains test examples for the QA 90 illustrating equip ment connections for the tests as well as step by step procedures for obtaining desired test measurements For more information on safety testing and an explanation of protective classes refer to Appendix A 60601 1 UL 2601 1 and VDE 0751 Testing The self calibration function of the QA 90 is used to determine test lead resistance and for the values to be taken into account during subsequent testing 1 Prior to performing self calibration connect a test lead between the enclosure and earth connectors or the dual lead inputs on the front face of the QA 90 see below Disconnect all other leads Test Lead Enclosure to Earth tas Test Lead Dual Lead Press SETUP F3 in MAIN MENU Press CAL F3 in SYSTEM SETUP In the SELF CALIBRATION window select an option by press ing either Calibrate test lead enclosure ground F6 or Cali brate test lead dual float F5 Equipment Code Sequence Name lt Class CL1 0 leads in 0 modules gt 4 1 SYSTEM SETUP Operator sare lt Establishment SELF CALIBRATION Calibrate test lead enclosure earth gt lt i Calibrate test lead dual float 5 test result for the calibration appears in the display wh
38. tputs Range 0 2000 mOhm Resolution 1 mOhm Accuracy 2 of full scale 1 LSD No of Tests 1 2 or multiple Insulating Resistance The measurement of the insulating resistance may be executed between casing and power unit or between patient module and power unit Test voltage 500VDC through a 130 kOhm limiting resistor No of Tests 1 2 or multiple Range 1 50 mOhm Resolution 1 mOhm Accuracy 2 of full scale 1 LSD Range 51 200 mOhm Resolution 1 mOhm Accuracy 2 of full scale 1 LSD Leakage Currents All measurements can be performed with a IEC 601 1 filter patient equiva lent or without flat frequency response The filter can be exchanged with filters covering other standards All measurements can be performed as true RMS measurements or AC DC measurements The following leakage currents can be measured Ground leakage current No of Tests 4 Enclosure leakage current No of Tests 6 or multiple Differential current No of Tests 2 Substitute equipment lekage current No of Tests 1 Direct leakage current No of Tests 2 Leakage current fig 9 No of Tests 1 1 3 General Information The following leakage currents are measured for each module Patient leakage current No Mains on applied part leakage current No Patient Auxiliary current No Substitute patient leakage current No Floating dual lead measurement of No leakage currents of Tests 6 of Tests 2 of Tests 6 of Tests 1 of T
39. ulation of the mains part fail and then a second insulating barrier exists to prevent the mains from coming into contact with the user or patient See illustration below MAINS Extra insulation Basic insulation 4 Class 3 Equipment of this classification is no longer manufactured and the classification was removed from IEC 601 1 in 1988 The equipment was powered via an isolating or safety transformer which generated at its secondary winding a Medical Safety Extra Low Voltage MSELV Safety Transformer Basic insulation 5 Symbols A particular degree of protection afforded a patient against an electric shock arriving from the applied part defines the type of applied part The symbols for each type of protection are shown be low Symbols _ Description Symbols Description Type B Defib Protection Type BF Defib Protection Type CF Defib Protection Classes 1 2 or 3 equipment or I P equipment providing an adequate degree of protection against electrical shock particularly regarding allowable leakage cur rents and reliability of the protective earth connection BF Type B equipment with an F type isolated floating applied part CF Classes 1 or 2 equipment or I P equipment providing a high degree of protec tion against electrical shock particularly with regard to allowable leakage cur rents and having an F type isolated floating applied part cardiac protection A 2 6 Generic
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