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TEST REPORT MEDICAL ELECTRICAL EQUIPMENT

1. 3 protective earth contact in the mains plug Test equipment See attached list requirement R max 0 2 Ohm are tabled below If the impedance of protective earth connections other than in 18 f exceeds 0 1 Ohm the allowable value of the enclosure leakage current is not exceeded in single fault condition 18k Functional earth terminals are not used to provide protective earthing 181 For Class II equipment with isolated internal screens and with a power supply cord the third conductor is used only as functional earth of these screens and is coloured green yellow insulation of such screens and all internal wiring connected to them is double insulation or reinforced insulation see also 20 3 marking of functional earth terminal is distinguished from protective earth terminal and is explained in accompanying documents Test of insulation see Clause 20 Page 22 of 73 Nemko ref no 200043138 AUXILIARY CURRENTS Equipment with multiple patient Not applicable connections Patient leakage current and patient auxiliary current do not exceed allowable values while one or more patient connections are disconnected from the patient or disconnected from the patient and earthed Allowable values see 19 4 19 4 Tests before humidity preconditioning comment below treatment In normal condition In single fault condition CONTINUOUS LEAKAGE CURRENTS AND PATIENTS Type of leakage current All
2. Nemko ref no TEST REPORT MEDICAL ELECTRICAL EQUIPMENT Equipment Product Name and address of the applicant Name and address of the manufacturer Name and address of the factory Trade mark Model type Rating and principal characteristics Serial no Test sample s received date Tested in the period dates Tested according to Result of testing LCD type Computer Advantech Co Ltd 4F No 108 3 Ming Chuan Road Shing Tien City Taipei TAIWAN R O C Advantech Co Ltd 4F No 108 3 Ming Chuan Road Shing Tien City Taipei TAIWAN R O C Advantech Co Ltd FI 7 NO 1 Lane 169 Kang Ning Street Xi Zhi Town Taipei Hsien TAIWAN R O C ADVANTECH PPC xxyM Explanation for xxy on page 3 in this report 100 250Vac 3A 50 60Hz Class equipment 24 oct 2000 Oct Nov 2000 TEC 60601 1 2 ed 1988 Amend 1 1991 Amend 2 1995 Corrigendum June 1995 MEDICAL ELECTRICAL EQUIPMENT Part 1 General requirements for safety The equipment complies with the above mentioned standards The test results relate only to the sample s tested Name and address of the testing laboratory Tested by Verified by Nemko AS Telephone 47 22 96 03 30 Fax 47 22 96 05 50 P O BOX 73 BLINDERN N 0314 OSLO NORWAY Signature Johny Giang Signature Frank Skarpsno Verdicts are placed in the column to the right P Pass F Fail N Not applicable
3. sra f 12 upc body 24 49 A Table Xb Promem a as s o rwa ia Ficotermene o o o a ww 20 Surface of PC Table Xa o a e a mma a o Soo Skynet SNP 8086 M See Nemko ref 200039133 T T O O O According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 153M zT Page 34 of 73 Nemko ref no 200043138 42 1 42 2 Determination of the temperature with Block vent test thermocouples Measuring point Measured Calculated Allowed Remarks temp temp max temp At K T C T C Formas OOO O OO O SS mes id s a i a mi E mi E 72 e 16 T1 coil for inverter 6e Table Xa 17 T1 core for inverter 55 Table Xa 18 L1 coil for inverter fod Table Xb 19 Surface of enclosure Table Xa Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 120M Page 35 of 73 Nemko ref no 200043138 Measuring point Measured Calculated Allowed Remarks temp temp max temp Block vent test At K T C TCC Ponerinputzaoven coe SSS S E E Mi Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 153M Page 36 of 73 Ne
4. Considered Information 200043138 Due to Nemko s computerised handling of test reports the layout of this form is modified compared to the original TRF published by EMEDCA 1992 12 01 The content fully covers the original TRF This form is only for use by Nemko or by others according to special agreement with Nemko The completed test report is not valid for external use unless issued by Nemko or attached to a Nemko certification document The report shall not be reproduced without written permission from Nemko and may then only be copied in full Issue Nemko 97 09 05 Page 1 of 73 Nemko ref no 200043138 DESCRIPTION OF EQUIPMENT UNDER TEST The PPC 150 panel PC is a multimedia Pentium MMX processor based computer that is designed to serve as a human machine interface HMI and as a desktop computer It is a PC based system with 15 color TFT LCD display on board PCI Ethernet controller multi COM port interfaces and a 16 bit audio controller With built in CD ROM drive floppy drive and PCMCIA ezpansion sockets NAME AND ADDRESS OF PRODUCTION SITES FACTORIES a an INFORMATION ABOUT THE STANDARDS DOCUMENTS CONSIDERED EN 60601 1 1990 A1 1993 A2 1995 A13 1996 Corrigenda July 1994 EMC standard EN 60601 1 2 1993 TESTED ACCORDING TO NATIONAL REQUIREMENTS FOR THE FOLLOWING COUNTRIES LIST OF APPENDIXES ENCLOSURES TO THE TEST REPORT Page 2 of 73 Nemko ref no 200043138 Ss S
5. TRN 0067 TDK SRW15 20E M T11H004 NIA 15 20EM T11H004 Nemko ref no 200043138 The electrical insulation between primary winding and other windings screens and the core of the transformer s have been investigated by the tests performed as described in Clause 20 Insulation between turns and layers test Not applicable SMP used performed according to 57 9 2 Insula tion material class Class B Class B Nominal rated voltages and currents of the windings 100 250Vac 3A A construction diagram has to be added to this test report for each transformer mentioned above See Nemko ref No 200039133 General construction Protection devices manufacturer type and rating location Comments The transformer consists of windings wounded on a bobbin with separate integrated forms The barrier between the primary and secondary windings has a split which increase the distance between them Creepage distances and air clearances of See Nemko ref No 200039133 transformers Insulation between Ref One of the following methods is used to separate primary from secondary and patient voltage V connected windings 57 9 4 c Means are provided to prevent displacement of end turns Air clearance mm Creepage distance mm Pinay seas wo 50 s a0 _ Primary Secondary 3 4 Parts other than windings B One bobbin with concentric windings separated by double or reinforced insula
6. Determination of the temperature rise Not applicable SMP used of copper windings by the resistance method At B R 93454 t t t R Initials Tester Date Quantity Used in tests Supply voltage V o Supply power VA Output power VA O Winding Ry Q R Q Room temperat Allowed Remarks 4C CO ACK TCC TCC Remarks Comments According to IEC 60601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Surface temperatures of applied parts No applied parts used not intended to supply heat to a patient do not exceed 41 C Guards for preventing contact with hot Not applicable No hot accessible surfces accessible surfaces are removable only with the aid of a tool FIRE PREVENTION Strength and rigidity of the equipment The equipment is well constructed with regard to avoid are sufficient to avoid fire hazards see fire hazard 21 Oxygen enriched atmospheres No general requirement Page 40 of 73 Nemko ref no 200043138 OVERFLOW SPILLAGE LEAKAGE HUMIDITY INGRESS OF LIQUIDS CLEANING STERILIZATION DISINFECTION AND COMPATIBILITY Equipment containing a liquid No containing a liquid reservoir used reservoir The equipment is electrically safe after 15 overfill steadily over a period of 1 min Transportable equipment is electrically safe after additionally having been tilted through 15 in least favour
7. SURFACES CORNERS AND EDGES There are no rough surfaces sharp The edges are well rounded corners flange or frame edges and burrs which may cause injury or damage za STABILITY IN NORMAL USE B 24 1 4 3 Equipment does not overbalance when Tested tilted through an angle of 10 2 If equipment overbalances when tilted See above 10 it does not overbalance when tilted 5 in any position of normal use excluding transport 10 in the condition specified for transport The equipment carries a warning notice for transport Equipment or its parts with a mass of more than 20 kg is provided with handling devices grips etc is provided with handling instructions for lifting and assembling Portable equipment with a mass of more than 20 kg carrying handle s suitably placed that equipment may be carried by 2 or more persons EXPELLED PARTS Protective means are provided where Not applicable expelled parts of the equipment could constitute a safety hazard Page 28 of 73 Nemko ref no 200043138 Display vacuum tubes with a face Not applicable dimension of 16 cm or larger are intrinsically safe with respect to effects of implosion of tubes and to mechanical impact or the enclosure of the equipment is provided with adequate protection against implosion 260 VIBRATION AND NOISE PNEUMATIC AND HYDRAULIC POWER B 2B SUSPENDED MASSES B 28 3 Suspension systems with safety No sus
8. barriers are provided Terminals of components used for external conductors comply with specified requirements and are properly marked see 6 2 h j and k Screws and nuts which clamp external conductors are not used to fix any other component other than internal conductors unlikely to be displaced Barriers provided Terminals including any protective earth terminal are closely grouped to allow easy connection Protective earth conductor see 58 Marking of mains terminals see 6 2 Mains terminal devices are so located or shielded that there is no risk of accidental contact between live parts and accessible conductive parts and for class II equipment between live parts and conductive parts separated from accessible parts by supplementary insulation Single strand of wire 8 mm Test result Tightening or loosening of clamping means of conductors does not subject internal wiring to stress does not reduce creepage distances and air clearances below allowable values Cross sectional area of the conductor used in the fastening and loosening test Mains terminal devices are inaccessible without the use of a tool Page 54 of 73 Nemko ref no 200043138 57 5 d Effective connection to mains terminals does not require special preparation of cables Conductors are not damaged or dis placed when tightening or loosening of clamping screws or nuts Fixing of wiring See Sub clause 56 1 f P List of fuses and ov
9. between contacts of thermal cut outs Page 48 of 73 Nemko ref no 200043138 Nn ion Nn Protective devices Protective devices which operate by producing a short circuit which results in operation of an overcurrent protection device in supply mains system not used see also 59 3 56 6 Temperature and overload control devices 56 6 a Thermal cut outs which require Not used soldering to reset are not used Thermal safety devices are provided to prevent temperature limits being exceeded An independent non self resetting thermal cut out is provided where the failure of a thermostat may cause a hazard The operating temperature of the above thermal cut out is between the upper limit of the first thermostat and the safe limit for the function There is an audible alarm where loss of function could present a safety hazard Test of thermal cut outs and overcurrent releases Heated liquid containers are protected against dangerous overheating when container is empty Means provided for varying the temperature setting of thermostats the temperature setting is clearly indicated The operating temperature of thermal cut outs is clearly indicated 56 7al Adequately ventilation 56 7 a2 Accidental short circuiting is prevented Note Lithium batteries 56 7 b Incorrect polarity of connection Not applicable A back up Lithium battery used Not prevented Note Lithium batteries internally powered equipment 1 Establis
10. change over device indicates the selected class clearly C j A tool for change over is necessary The equipment complies with all requirements for the selected class at any given time Class II position The device interrupts the connection of protective earth conductor to equipment or changes it into functional earth conductor compliance with 18 2 E a functional earth connections cf Sub clause 18 k and 1 Class I and II equipment Equipment is provided with an additional protection according to the requirements of Class I or Class II equipment Page 16 of 73 Nemko ref no 200043138 14 4 b No safety hazard develop when a Not applicable connection with the wrong polarity is made in equipment specified for power supply from an external d c power source e g for use in ambulances 14 6 c Applied parts suitable for direct cardiac Not applicable application are of type CF 14 5 b Equipment also having means of Not applicable connection to supply mains complies also with requirements for Class I or I while so connected Page 17 of 73 Nemko ref no 200043138 LIMITATION OF VOLTAGE AND OR ENERGY 15b Equipment with mains plug so designed that the voltage 1 sec after disconnection does not exceed 60 V protective earth Measured value Maximum residual voltage in the mains plug 1 second after disconnection measured in the least favourable position of the on off switch if any Remark pin
11. g2 By protectively earthed conductive part e g screen 17 g3 By separate earthed intermediate circuit Not applicable Page 20 of 73 Nemko ref no 200043138 By protective impedances limiting current to accessible part Leakage currents measurements when required 17h Adequate arrangements used to isolate defibrillation proof applied parts from other parts Peak voltage between Y1 and Y2 does not exceed 1 V After recovery time equipment continues to perform its intended function PROTECTIVE EARTHING FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION 18a Sufficiently low impedance to the protective earth terminal 18 f and 18 g Suitable connection between protective earth terminal and protective conductor in the installation 18 f Means for connection of potentially Not used equalisation conductor complies with specified requirements This connection complies with following requirements readily accessible no possibility to accidental disconnection in normal use conductor is detachable without the use of a tool power supply cord does not include potential equalisation conductor connection is marked with symbol Page 21 of 73 Nemko ref no 200043138 Impedance of protective earthing system Impedance between any accessible metal part and 1 protective earth terminal PE requirement R max 0 1 Ohm 2 protective earth contact in appliance inlet requirement R max 0 1 Ohm
12. requirements of IEC 601 1 Instructions for use identify risks Not applicable associated with disposal of waste residues etc and of equipment accessories at end of their lives Further it provides advice on minimising these risks fesse few Technical description provides all data The Technical and Service Manual is well written and essential for safe operation including contains all necessary information required data in Sub clause 6 1 and all characteristics of the equipment A statement whether particular Not applicable measures or particular conditions are to be observed for installing equipment and bringing equipment into use Required type and rating of fuses Not applicable Notpermanently installed equipment utilised in the mains supply circuit external to permanently installed equipment Instructions for replacement of Not applicable interchangeable and or detachable parts which are subject to deterioration during normal use Page 14 of 73 Nemko ref no 200043138 A a a pe B OoOo etc The technical description contains a Not applicable statement that the supplier will make available on request circuit diagrams component part lists descriptions calibration instructions etc in order to assist user in case of necessary reparations 6 8 3 d Environmental conditions for transport and storage The technical description contains a specification of the permissible environmental conditi
13. the aid of tool or an automatic device makes these parts not live when the enclosure is opened or removed Live parts are inaccessible to the test Not applicable rod through openings for adjustment of pre set controls Page 19 of 73 Nemko ref no 200043138 17 seranamion E Separation method of the applied part No applied part from live parts so that allowable w currents are not exceeded su a2 By protectively earthed conductive part e a screen 17a 17a3 e By separate earthed intermediate circuit separate earthed intermediate circuit 17 a5 By protective impedances limiting current to applied part 17a6 Other method e g specified in E standard Tester Date Additional leakage current test in single fault conditions Fault condition Earth leakage current Enclosure leakage Patient leakage Patient auxiliary description current current current There is no conductive connection between applied parts and accessible conductive parts which are not protectively earthed Supplementary insulation between Not used hand held flexible shafts and motor shafts Class I equipment Adequate isolation of accessible metal parts from motor shaft Rated motor voltage Test voltage Air clearances creepage distances mm mm Separation method of accessible parts other than applied parts from live parts so that allowable leakage currents are not exceeded 17 g1 Basic insulation accessible part earthed 17
14. 1 d Fixing of components The movement of components is prevented P Fixing of wiring Conductors and connectors are adequately secured and insulated Accidental detachment does not result in a safety hazard Incorrect interconnection of accessible No such interconnection connectors is prevented where a hazard may be caused Accessible parts are separated from live parts see 17 g Plugs for connection of patient circuit Not applicable No such connection of patient cannot be connected to other outlets Medical gas connections are not Not used interchangeable see Sub clause 6 6 and ISO R407 Accessible conductive parts are prevented from becoming live when connection between different part of the equipment is broken Connectors having conductive Not applicable connection to patient are constructed so that no conductive connection of the connector remote from patient can contact earth or hazardous voltages Test with flat conductive surface Test with straight unjointed test finger Test if able to be plugged into a mains socket Capacitors not connected between live Not applicable parts and non protectively earthed accessible conductive parts Capacitors between the mains part and earthed accessible parts comply with TEC 60384 14 or equivalent The enclosure of capacitors are not secured directly to non protectively earthed accessible metal parts Capacitors or other spark suppression devices are not connected
15. 7 a in notes above Page 66 of 73 Nemko ref no 200043138 APPENDIX 3 ia Fig 23 in Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT IEC 60601 1 current l ma iin ae a ny I ee 1 1 i Normal Condition Measured uA Before Comments and Before and after humidity preconditioning treatment Page 67 of 73 Nemko ref no 200043138 19 412 APPENDIX 4 E Fig 21 in Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT IEC 60601 1 current with mains voltage on the f type isolated floating applied part S S10 Before 1 After 1 1 1 1 5 fo ee a ee ee eo 4 E a C E a ooon o SSS E e o o oe and Before and after humidity preconditioning treatment Note S7 not used for Class II equipment NC Normal Conditions 1 Switch Closed SFC Single Fault Condition 0 Switch Open Page 68 of 73 Fig 24 in IEC 60601 1 Comments 1 Nemko ref no APPENDIX 4 Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT current with mains voltage on the f type isolated floating applied part ye am aeae ae e e a U oe m ee J ec a a ue a o eee oe L N Single Fault Condition Measured uA Before l and Before and after humidity preconditioning treatment 200043138 Page 69 of 73 Nemko ref no 200043138 19 4 h3 APPENDIX 5 A Fig 22 in Measurement of the pati
16. 8 IEC 601 1 does not require to measure this Page 25 of 73 Nemko ref no 200043138 DIELECTRIC STRENGTH after humidity preconditioning treatment Equipment Humidity room N3205 High voltage supply N601 Ls Initials Tester Date JohnyG 11 2000 P Equipment Insulation Insulation Reference Test voltage Remarks observations under test resistance voltage All A a 250 V AC 1 500 V AC O equipment A a2 aa D a oO QO io 250 V AC 1 500 V AC O 250 V AC 4 000 V AC O types with gt oa i gt Equipment 21 MECHANICAL STRENGTH la 2 Rigidity of enclosure 45 N test force Tested with 45 N No damage to enclosure parts Strength of enclosure part and any No damage resulting in a safety hazard component thereon Impact hammer test 0 5 J On portable equipment carrying No handles or grips used handles or grips withstand the requirements of the loading test Test force four times the weight of equipment Page 26 of 73 Nemko ref no 200043138 No damage to parts of patient support No patien support parts used and or immobilisation system after the loading test 1350 N and 2700 N tests 21 3 The test force for foot rests and chairs shall be twice the specified maximum load or if not specified the test force shall be 2 7 KN The test force shall be distributed over an area of 0 1 m surface for 1 minute 21 5 Hand held equipment or equipment Not hand held equ
17. FC Additional SFC Sl 1 S7 1 S1 0 S7 1 Sl 1 S7 0 Sl 1 S7 1 Measured uae Measured Measured Measured ai a A E DE a Je CERE A os ea or ma eon o e a a z o of os os 7 7 a5 26 o f os os os os os os po aa oa os os oe oe o jos ij a j ar ae ea a eo o oa os is s ea e E E l and Before and after humidity preconditioning treatment Note S7 not used for Class I NC Normal Conditions 1 Switch Closed describe additional SFC equipment SFC Single Fault Condition 0 Switch Open according to Sub clause 17 a in notes above Page 64 of 73 Nemko ref no 200043138 APPENDIX 2 a Fig 18 in Measurement of the enclosure FOR INTERNALLY POWERED EQUIPMENT IEC 60601 1 leakage current See fig 18 on previous page Using MD2 between different parts of the enclosure Normal Condition Measured uA and Before and after humidity preconditioning treatment Page 65 of 73 Nemko ref no 200043138 APPENDIX 3 F Measurement of the patient leakage FOR MAINS OPERATED EQUIPMENT kg current Switch position NC SFC SFC Additional SFC Sl 1 S7 1 S1 0 S7 1 Sl 1 S7 0 Sl 1 S7 1 Measured Measured ae Measured A Measured uae and Before and after humidity preconditioning treatment Note S7 not used for Class II NC Normal Conditions 1 Switch Closed describe additional SFC equipment SFC Single Fault Condition 0 Switch Open according to Sub clause 1
18. Sub clause 3 6 f 51 4 Equipment providing both low and Not applicable high intensity outputs Minimised possibility of high intensity output being selected accidentally 2 1 52 ABNORMAL OPERATION AND FAULT CONDITIONS 52 1 Equipment shall be so designed and manufactured that even in single fault condition no safety hazard as described under Sub clause 52 4 exists see 3 1 and 13 5 Safety of equipment incorporating The equipment does not include programmable programmable electronic systems electronic subsystems as specified in IEC 60601 1 4 PES conforms to the rules of future 1996 IEC 601 1 4 52 5 1 Overloading of mains supply Tests see Sub clause 57 9 transformers See Nemko ref 200039133 52 5 3 Short circuiting one part of a double Not applicable insulation 52 5 4 Interruption of the protective earth conductor tests as described in Sub clause 19 4 52 5 5 Impairment of cooling Temperatures Fan used do not exceed 1 7 times values of Clause 42 Tables Xa and Xb minus 17 5 degrees C 52 5 6 Locking of moving parts see also No moving parts 52 5 8 Page 44 of 73 Nemko ref no 200043138 52 5 7 Interruption and short circuiting of Not applicable motor capacitors see also 52 5 8 Not used E A D a 7 i m i aS winding 52 5 8 Additional tests for motor operated Not used equipment 52 5 9 Failure of components refer to Table See the table below in Clause 56 X1 and X2 capacitors betwee
19. UMMARY OF TESTING B Evaluation of Results If not explicitly stated otherwise in the standard the test is passed if the measurement value is equal to or below the limit line regardless of the uncertainty of the measurement If the measurement value is above the limit line the test is not passed ref IEC 60EE CTL sec 056 94 CLT Committee of Testing Laboratories The instrument accuracy is within limits agreed by this committee ref Nemko proc P227 Models PPC xxyM where xx can be 12 or 15 for 12 LCD or 15 LCD where y can be 0 9 This computer uses adaptor Skynet Model SNP 8086 M which has CB Page 3 of 73 Nemko ref no 200043138 LIST OF ATTACHMENTS PROVIDING FURTHER INFORMATION ON THE EQUIPMENT TESTED AND THE TEST METHODS The following attachments are added to this TRF or kept in file at the Testing Station mentioned at the cover page Statements on calibrations and measurement uncertainties where relevant of the measurement and test equipment as identified throughout this TRF Calibration All instruments used in the tests given in this report are calibrated and traceable to international standards Further information about tractability will be given on request Measurement Measurements uncertainties are calculated for all instruments and uncertainties instruments set ups given in this report Cakulations are based on the principles given in the standard EA 4 02 Dec 1999 Further information a
20. Y POWERED EQUIPMENT TEC 60601 1 auxiliary current een ree oy j I 1 I he ee oe ee ne ee ee ell Normal Condition Measured uA Before Comments 1 and Before and after humidity preconditioning treatment Page 73 of 73
21. able direction s if necessary with refilling No signs of wetting of uninsulated live parts Dielectric strength test if deemed necessary 44 3 Spillage Safety of the equipment does not Not applicable change in consequence of spillage test performed by the method mentioned in the standard 200 ml of water for approximately 15 s from a height of e Safety of the equipment does not Not applicable change in consequence of leakage test performed by the method mentioned in the standard drops of water Equipment shall be so constructed that liquid which might escape in a single fault condition does not cause a safety hazard see also Sub clause 52 4 1 Checked by the pre conditioning 48H treatment and tests see 4 10 46 o Ingress of liquids Equipment checked by relevant tests of Not applicable IPX0O IEC 60 529 Equipment withstands dielectric strength test in Clause 20 Water if entered equipment has no harmful effect in particular there is no trace of water on insulation for which creepage distances are specified Page 41 of 73 Nemko ref no 200043138 Equipment equipment parts capable of See Sub clause 6 8 2 d withstanding cleaning sterilisation or disinfection likely to be encountered in normal use or specified by the manufacturer Test with saturated steam at 134 Not applicable degrees C 4 for 20 cycles each of 20 min duration Safety of the equipment not impaired by the test N
22. acuum tubes excited by voltages exceeding 5 kV does not produce an exposure exceeding 130 nC kg 0 5 mR ALPHA BETA GAMMA NEUTRON RADIATION AND OTHER PARTICLE RADIATION ao MICROWAVE RADIATION 32o LIGHT RADIATION INCLUDING LASERS B 33 INFRA RED RADIATION F 34 ULTRAVIOLET RADIATION 35 ACOUSTICAL ENERGY INCLUDING ULTRA SONICS F Page 30 of 73 Y Memko Nemko ref no 200043138 ELECTROMAGNETIC COMPATIBILITY 37 41 REQUIREMENTS FOR CATEGORY AP AND APG EQUIPMENT See additional test report form Not applicable Page 31 of 73 Nemko ref no 200043138 EXCESSIVE TEMPERATURES Ambient temperature during See tables below measurements Atmospheric pressure 995hPa Equipment Humidity N2531 Pressure N2842 Initials Tester Date JohnyG 11 2000 42 1 42 2 Determination of the temperature with thermocouples N3008 N3635 N2859 N3132 Initials Tester Date JohnyG 11 2000 Quantity Rated Remarks Supply voltage V 100 250V AC wesa f o S Measuring point Measured Calculated Measured Calculated Allowed Remarks temp temp temp temp max At K T C At K T C temp T C A IP 90Vac 60Hz B IP 275Vac 60Hz 130 C 130 C sa Frecottormvener e Tae _ al 12 SMP for building in seme ennn Nemko ref 200039133 a RE eR a TTR aR aR Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperatu
23. bout measurements uncertainties will be given on request Document title identification Kept in file at Nemko P31000 ATT No Not attached List of worksheets which describe measurement procedures or test methods where practicable Document title identification Kept in file at Nemko P31000 ATT No Not attached List of equipment or units tested and or accompanying units and accessories in case not all individual units can be mentioned on the front page Document title identification See summary of testing in this report ATT No Not attached Technical design documents of components having basic supplementary of reinforced insulation e g transformer specification mentioning the insulation class of the insulation materials applied A to H Document title identification Kept in file at Nemko ATT No Not attached Description of safety systems specifying for example safety circuits redundant circuits double circuits hardware software safety measures temperature controls etc Document title identification Kept in file at Nemko ATT No Not attached Si PERSONNEL INITIALS USED THROUGHOUT THIS TRF Fas Fanome Simm P This Part 1 TRF contains 73 pages numbered from 7 to 73 a This TRF contains photographs Attachment no 1 LG Attachment no 2 EMC report no 200045135 Page 4 of 73 EQUIPMENT when transported stored installed operated in NORMAL USE and maintained according to the inst
24. dard C 59 2 b Insulation characteristics mechanical Test of enclosure parts Temperature of ball 90 strength and resistance to heat and fire d 1 3mm is retained Result of the ball pressure test Insulation is not likely to be impaired by deposition of dirt or dust resulting from wear of parts within the equipment such that creepage distances and clearances are reduced below specified values Ceramic materials and the like Not used specified in this sub clause are not used as supplementary or reinforced insulation Rubber materials used as Class equipmet supplementary insulation in class II equipment are resistant to ageing oxygen test and arranged and dimensioned adequately Creepage distances are not reduced below values specified in 57 10 despite any cracks in such insulation Page 61 of 73 Nemko ref no 200043138 Insulating materials in which heating No heating elements used elements are embedded are not used as reinforced insulation See Sub clause 57 6 An internal No internal electrical power source electrical power source in equipment is provided with an appropriately rated device to protect against fire hazards Protective means used Inspection of design data Fuse elements replaceable without Not applicable Must open the enclosure opening the enclosure are fully enclosed in a fuseholder and fuse replacement does not cause safety hazard Test with standard test finger Live
25. ed Equivalent to basic 250 1 6 4 6 3 4 6 insulation between parts of opposite polarity Basic or supplementary insulation Double insulation or reinforced insulation Page 59 of 73 Nemko ref no 200043138 58 PROTECTIVE EARTHING TERMINALS AND CONNECTIONS B 58 1 Clamping means of the protective earth terminal for fixed supply conductors or power supply cords comply with requirements of Sub clause 57 5 c Not possible to loosen the clamping means without use of a tool Screws for internal protective earth connections are covered or protected against loosening from outside Internal protective earthing connections by means of screw soldering crimping wrapping welding or a reliable pressure contact Where an appliance inlet is used for the supply connection its earth pin is regarded as the protective earth terminal The protective earth terminal is not used for connection between different parts or fixing of any component not related to protective or functional earthing Where the protective earth connections are made via a plug or socket device the protective earth connection is made before and interrupted after the supply connections during connection and interrupting Fixing of wiring in the applied part and Not applicable No applied part the mains part see Sub clause 56 1 f are protected against contact with No moving parts The wiring is adequately protected moving parts and friction wi
26. ent leakage FOR MAINS OPERATED EQUIPMENT IEC 60601 1 current with mains voltage on a signal input or signal output part S5 1 1 1 1 ict 113 113 113 13 a a ict 0 1 0 1 0 1 0 1 0 a arr 7 a and Before and after humidity preconditioning treatment Note S7 not used for Class II equipment NC Normal Conditions 1 Switch Closed SFC Single Fault Condition 0 Switch Open aja aja amp Page 70 of 73 Nemko ref no 200043138 APPENDIX 5 Fig 25 in Measurement of the patient leakage FOR INTERNALLY POWERED EQUIPMENT IEC 60601 1 current with mains voltage on a signal input or signal output part Single Fault Condition Measured uA Before Comments l and Before and after humidity preconditioning treatment Page 71 of 73 Nemko ref no 200043138 19 4 APPENDIX 6 Fig i in Measurement of the patient FOR MAINS OPERATED EQUIPMENT TEC 60601 1 auxiliary current Additional SFC S1 1 S7 1 S1 0 S7 1 S1 1 S7 0 S1 1 S7 1 Measured uA Measured uA Measured uA Measured uA Before and after humidity preconditioning treatment Note S7 not used for Class II NC Normal Conditions 1 Switch Closed describe additional SFC equipment SFC Single Fault Condition 0 Switch Open according to Sub clause 17 a in notes above Page 72 of 73 Nemko ref no 200043138 APPENDIX 6 ia Fig 27 in Measurement of the patient FOR INTERNALL
27. epage distance and air clearances IEC 60328 replaced by IEC 60 61058 1 57 1 f Mains switches are not incorporated in power supply cord or flexible leads 57 1 g The directions of movement of actuators of Two pole switch disconnects the voltage Mounted mains switches comply with IEC 60447 according to IEC 60447 Suitable plug device used to isolate the non permanently installed equipment from the supply mains 57 1 m Fuses and semiconductor devices are not used as isolating devices Page 51 of 73 Nemko ref no 200043138 Auxiliary mains sockets outlets Not used Mains connectors appliance inlets and the cannot accept a mains plug does not apply to emergency trolleys Number of socket outlets on emergency trolleys are limited to maximum 4 and they are properly marked Power supply cords Equipment not provided with more than one connection to supply mains Alternative connections to a different supply system do not cause safety hazards when more than one connection is made simultaneously Mains plug not fitted with more than one power supply cord Equipment not intended to be permanently Appliance inlet connected to fixed wiring is provided with either a power supply cord or an appliance Power supply cords not less robust than The cord is of type HO3VV F ordinary flexible cord designation 53 of IEC 60245 or IEC 60227 PVC insulated power supply cords not used Not applicable No external metal parts exceddin
28. er current releases See table at the beginning of Clause 56 in this TRF There are fuses or over current releases in each supply lead for class I equipment and class II equipment having a functional earth according to Sub clause 18 1 A protective earth conductor is not fused No fuse is fitted in neutral conductor of permanently installed equipment 57 8 a The insulation of an individual conductor is The internal mains wiring has at least the same at least equivalent to that required by IEC quality and equivalency to that required in IEC There is at least one mains fuse for other Class equipment single phase class II equipment 60227 or IEC 60245 otherwise the conductor 60227 245 is considered bare 57 8b The cross sectional area of internal wiring Not applicable Not used between the mains terminal and protective devices is not less than minimum required for the power supply cord Measured area see Sub clause 57 3 c e Initials Tester Date Tritials Tester Date A The cross sectional area of other wiring in the mains part and sizes of tracks on printed wiring circuits are sufficient to prevent any fire hazard in case of possible fault currents In case of doubt concerning adequacy of incorporated overcurrent protection connecting test performed No safety hazard arises Mains supply transformers refer to table See list of components below Insulation of mains supply transformers protected against overheati
29. g for equipment having external metal parts 75 TCT exceeding 75 C unless cord rated for the temperature measured Cross sectional area of power supply cords 0 75mm Cu See list of components see Table XV Data sheet Initials Tester Date Stranded conductors fixed by any clamping Not applicable means or screws are not soldered Page 52 of 73 Nemko ref no 200043138 Cords anchorages Detachable power supply cord used The equipment or its mains connectors incorporate a cable anchoring device to relieve strain on conductors and prevent abrasion of covering no knots etc The construction and materials of the cord anchorages are made of insulating material or insulated from unearthed accessible metal parts by supplementary insulation or having an insulating lining complying with the requirements for basic insulation fixed to the cord anchorage if an insulation fault on power supply cord could make accessible parts live Screws associated with cable replacement are Clamping screws do not bear directly on the cord insulation not used to fix other components EE Conductors so arranged that if the cord anchorage fails no strain on protective earth conductor occurs as long as phase conductors are in contact with their terminals Pull test 25 times Torque test for 1 min a distance of more than 1 mm from their normally connected position Creepage distances and air clearances are not reduced below the
30. h whether there is a possibility of making an incorrect battery connection 2 Where such a possibility exists establishing the effect of an incorrect battery connection Type of battery is clearly marked see Battery type M4T28 BR12SH1 also 6 2 d Battery state No general requirement Page 49 of 73 Nemko ref no 200043138 56 8 Indicators Unless indication is otherwise apparent Colours see Sub clause 6 7 to the operator from normal operating position indicator lights are provided to indicate that equipment is See Sub clause 6 3 a energised to indicate the operation of non Not applicable luminous heaters to indicate when output exists if a Not applicable safety hazard could result Charging mode is visibly indicated to Not applicable the operator 56 10 a Accessible parts of electrical controls No actuating parts comply with requirements in Sub clause 16 c Fixing prevention of maladjustments Actuating parts are adequately secured to prevent them working loose during normal use Controls are secured to prevent movement relative to scale marking Detachable indicating devices are prevented from incorrect connection without the use of a tool Initials Tester Date Rotating controls Gripping diameter of the Test torque Remarks knob mm Nm Pull controls Axial pull test force Nm Remarks l Stops of adequate mechanical strength Not applicable are provided on rotati
31. ipment parts are safe after drop test dropping height 1 m Portable and mobile equipment is able to withstand rough handling Propel test of mobile equipment Not applicable performed 20 times Equipment complies with requirements of this standard 2o o MOVING PARTS Moving parts of transportable No moving parts used equipment are provided with guards which form an integral part of the equipment 22 2 b Moving parts of stationary equipment are provided with similar guards as above unless it is evident that equivalent protection is separately provided during installation 22 3 Cords ropes chains and bands are confined so they cannot run off or jump out of their guiding devices 2 6 Other means used to prevent a safety hazard Mechanical safeguard means are removable only with a tool 22 4 Dangerous movements of equipment parts which may cause physical injury to the patient are possible only by the continuous activation of the control 2 Parts of equipment subject to mechanical wear are accessible for inspection Page 27 of 73 Nemko ref no 200043138 To remove an unexpected safety hazard caused by an electrically produced mechanical movement there are means for emergency switching of a relevant part The means for emergency switching are readily identifiable and accessible and do not introduce a further safety hazard Current breaking capability i operate as aresult of one single action 23
32. ls is not directed towards any person 45 7e Operation of device does not deposit material on parts causing possible safety hazard 45 7 f Ensures that the pressure does not exceed the maximum permissible working pressure by more than 10 if a failure occurs in the control of the supply pressure No shut off valve between the pressure relief device and the parts it is intended to protect Minimum number of cycles of operation is 100 000 except for bursting disks HUMAN ERRORS ELECTROSTATIC DISCHARGES Equipment parts and accessories No parts of the equipment or accessories are intended intended to come into contact with to come into contact with biological tissues cells or body biological tissues cells or body fluids fluids assessed and documented as given in ISO 10993 1 Inspection of information provided by manufacturer If automatically resetting thermal cut outs and overcurrent releases are used they give a safe condition by such resetting Means are provided for removal of Not applicable mechanical constrains on patients in case of a supply mains failure Page 43 of 73 Nemko ref no 200043138 MARKING OF CONTROLS AND INSTRUMENTS co PROTECTION AGAINST HAZARDOUS OUTPUT Intentional exceeding of safety limits No general requirement cf Appendix A Sub clause A2 Indication of parameters relevant to No general requirement cf Appendix A Sub clause A2 safety Reliability of components See
33. mko ref no 200043138 Measuring point Measured Calculated Allowed Remarks temp temp max temp Block vent test At K T C TCC Powerinputasovec core Sd ene e e o we dS 7 T1 coil for inverter 110 Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 150M mj Page 37 of 73 Nemko ref no 200043138 42 1 42 2 Determination of the temperature with Installed fan test thermocouples Measuring point Measured Calculated Allowed Remarks temp temp max temp At K TCC TCC Powerinputa0vee core __ SS fanbent 2c i d a i a mi E mi E 16 T1 coil for inverter 101 18 L1 coil for inverter o Tablexb i O 19 Surface of enclosure C es ee Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 120M Page 38 of 73 Nemko ref no 200043138 Measuring point Measured Calculated Allowed Remarks temp temp max temp Installed fan test At K TCC TCC Ponerinputzaoven core SSCS E E E Mi Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T Model PPC 153M Page 39 of 73 Nemko ref no 200043138 42 1 42 2
34. n parts of opposite polarity in the mains part and complying with IEC 60 384 14 exempted from this requirement 52 5 10 a 1 Thermostatically controlled equipment see 52 5 10 c and d 52 5 10 a2 Equipment with heating elements with short time rating see 52 5 10 c and e 52 5 10 a3 Other equipment with heating elements see 52 5 10 c 52 5 10 b Equipment having motors which are a part of equipment see 52 5 5 52 5 8 and 52 5 10 f 52 5 10 h 52 5 10b 1 Mention circuit component concerned e g regulator capacitor wiring etc and mention the fault condition e g disconnected short circuited etc Mention creepage distances separately if applicable refer to the text of 52 5 above 52 5 1 in the 601 1 standard 52 5 10 b 2 Mention for example safety hazards according to 3 1 and 13 and 52 4 Page 45 of 73 Nemko ref no 200043138 Test No Applied single fault condition refer to 52 5 1 Observed result e g hazards which arise or not 2 from 52 5 See Nemko ref No 200039133 ENVIRONMENTAL TESTS o See Sub clause 4 10 and Clause 10 CONSTRUCTIONAL REQUIREMENTS GENERAL E ENCLOSURES AND COVERS Ooo Page 46 of 73 Nemko ref no 200043138 COMPONENTS AND GENERAL ASSEMBLY LIST OF CRITICAL COMPONENT PARTS Approved b Manufacturer Type number Nominal ratings Operating Location pp y yp g P g ratings lt HAR gt R amp L WS 010 HO3W F 3G 0 75mm2 250Vac 16A Enclosure HB or bet
35. nded only for connection to specified equipment stated in instruction for use Cleaning disinfection and sterilisation of parts in contact with the patient Details about cleaning or disinfection Properly described or sterilisation methods that may be used for equipment parts which come into contact with the patient during normal use given in instruction for use Page 13 of 73 Nemko ref no 200043138 6 8 2 e Mains operated equipment with additional power source A warning statement referring to the Not applicable No used of additional power source necessity for periodical checking or replacement of an additional power source If Class I equipment a statement saying Not applicable that where the integrity of the external protective conductor in the installation or its arrangement is in doubt equipment shall be operated from its internal electrical power source 6 8 2 f Removal of primary batteries i e not No primary batteries used rechargeable batteries Instruction for use contains a warning to remove batteries if equipment is not likely to be used for some time unless no risk of safety hazard 6 8 2 g Rechargeable batteries Not rechargeable batteries Instructions to ensure safe use and adequate maintenance 6 8 2h Equipment with a specified power supply or battery charger Instructions for use identify power Not applicable supplies or battery chargers necessary to ensure compliance with the
36. ng in event of short circuit or overload see 57 9 1 a and b External protective devices connected such that failure of components cannot render the protective devices inoperative Page 55 of 73 Nemko ref no 200043138 o ee 1 rated supply voltage voltage range SMP mdoel SNP 8086 M C a O O O C oe o o sisters Test under the conditions specified in Clause 42 Tests under the conditions specified in Clause Temperatures during tests do not exceed values 42 until steady thermal conditions are given in Table XIX obtained Results See table below Loading of a section or winding of the See Nemko ref No 200039133 transformer SMP madel SNP 8086 M Supply voltage 250Vac 60Hz Winding under Test Duration At Final Notes test current ning C tCO max A T1 after D4 175 Unit shutdown No danger No for 5V damaged T1 after D3 175 Unit shutdown No danger No for 12V damaged LOAD 175 Unit shutdown No danger No damaged 175 Unit shutdown No danger No damaged gt For 5V E For 12V a w Page 56 of 73 Dielectric strength of electrical insulation between turns and layers Voltage used in test Frequency used in test gt Construction Identification reference marking e g T1 T2 etc Mains transforme T1 Inverter transformers T1 T2 Manufacturer and type SKYNET H K Electronic Co Ltd 360 8086 M Sen Huei
37. ng or movable parts of controls where necessary to prevent an unexpected change from maximum to minimum or vice versa of the controlled parameter where this could produce a safety hazard nitions A A Page 50 of 73 Nemko ref no 200043138 Cord connected hand held and foot operated control devices Voltages on cord connected control devices do not exceed 25 V a c or 60 V d c or peak value Circuits isolated from mains part see 17 g Hand held control devices No safety hazard as a result of the free fall test Sub clause 21 5 Foot operated control devices able to support the weight of an adult human being Test with an actuating force of 1350 N over an area of 625 mm No damage to the device resulting in a safety hazard Hand held and foot operated control devices do not change their control setting when inadvertently placed in abnormal position IP classification of foot operated control device at least IPX1 Electrical switching parts specified for use in operating rooms at least IPX8 Provided with adequate means of anchoring as for power supply cords see test of 57 4 57 MAINS PARTS COMPONENTS AND LAY OUT sa memso PSS The equipment has means for simultaneous disconnection of all supply poles Means for disconnection incorporated in equipment External means for disconnection are Not applicable specified in accompanying documents Switches for mains disconnection comply with cre
38. o appreciable signs of deterioration Dielectric strength test specified in Clause 20 withstood Pressure vessel with a pressure volume No pressure vessels used greater than 200 kPa x 1 and pressure greater than 50 kPa withstands the hydraulic test pressure Hydraulic test pressure The test pressure shall be maximum permissible working pressure multiplied by a factor obtained from Fig 38 The maximum pressure to which a part can be subjected in normal condition and single fault condition does not exceed the maximum permissible working pressure for the part The used maximum pressure is the highest of the following 45 3 a Rated maximum supply pressure from an external source 45 3b Pressure setting of a pressure relief device provided as part of the assembly Maximum pressure that can be developed by an air compressor that is part of the assembly unless the pressure is limited by a pressure relief device Equipment incorporates pressure relief device s where excessive pressure could occur If yes it complies with all the following requirements Connected as close as possible to the pressure vessel or parts of system it is intended to protect Page 42 of 73 Nemko ref no 200043138 45 7b Readily accessible for inspection maintenance and repair 45 7 Not capable of being adjusted or rendered inoperative without a tool 45 7 d Its discharge opening located and directed so that released materia
39. of category AP or APG oN 6 1s High voltage symbol Symbol 6 of table DII Dangerous voltage is used Protective packing requirement s Marking s for unpacking safety hazard s Removable protective means Durability of markings Tested with a cloth of rack soaked with in turn water methylated spirit and isopropyl alcohol 6 1 m 6 1n 6 1 p The sample label withstood the test Marking on the inside 6 2a Marking clearly legible Nominal supply voltage of Not permanently installed equipment permanently installed equipment marked inside or outside of equipment Maximum power loading of heating No heating elements used elements or lamp holders for heating lamps clearly and indelibly marked near or in the heater Heating elements or lamp holders for heating lamps not intended to be changed by operator and which can be changed only with the use of a tool have at least an identifying marking referring to information stated in the accompanying documents a ey N 5 Page 9 of 73 6 3a Nemko ref no 200043138 High voltage parts Symbol 6 of table DII Dangerous ae is used Type of battery and mode of insertion Back up battery Type M4T28 BR12SH1 if applicable marked see Sub clause rating 5V 50mAh 56 7 b Batteries not intended be changed by operator and which can be changed only with use of tool have at least marking referring to information in accompanying documents Fuse type and ra
40. ons for transport and storage The above said specification also repeated on the outside of the packaging Steady state current or power input Input power 100 250Vac 3A 50 60Hz does not exceed the marked rating by more than specified C T A A C E dP Comments Power input rated is measured at both 50 and 60Hz The 50Hz values are showed before and the 60Hz is back Remark PPC 15yM zT ozm ENVIRONMENTAL CONDITIONS B Equipment capable while packed for Considered OK transport and storage of being exposed to environmental conditions as stated by manufacturer see 6 8 3 d Operation of equipment according to Considered OK specified environment and power supply Deviation measured rated 100 rated Page 15 of 73 Nemko ref no 200043138 GENERAL Equipment so designed that risk of Considered OK electric shock obviated as far as practicable requirements as given in section three REQUIREMENTS RELATED TO CLASSIFICATION E If the mains part of equipment No external d c power source used specified for an external d c power source is isolated from accessible conductive parts by basic insulation only a separate protective earth conductor is provided Class II equipment is of one of the Not applicable Class equipment following types If equipment is fitted with a device for Not applicable changing over from class I to class IT protection the following requirements are fulfilled The
41. ons of internal protective earth conductors are green yellow at least at the terminations of the conductors Only protective earth functional Not used earth potential equalisation and inside earthing conductors cf 6 5 b are green yellow Colour of neutral conductor light blue according to IEC 60 227 or 245 Colours of phase conductors in power supply cord according to IEC 60 227 or 245 Additional protective earthing in multi conductor cords are marked green yellow at the ends of the additional conductors Identification of medical gas cylinders and connections Identification of content in accordance No medical gas used with ISO R32 Identification of connection point that errors are avoided when a replacement is made Page 11 of 73 Nemko ref no 200043138 Colour red only used for warning of No colour red used danger or and need for urgent action Dot matrix alphanumeric displays not considered to be indicator lights Colours of unilluminated push buttons Colour red only used in case of emergency Meaning of indicator lights Illuminated push button see IEC 60 Colour 73 anatase viin eser an reter Usor Mera OO O i fe All applicable classifications specified User Manual in Clause 5 are included in instructions for use and technical description markings in Sub clause 6 1 included in accompanying documents if not permanently affixed to equipment Warning statements and explanations Not u
42. ot internally powered equipment EQUIPMENT Markings of EQUIPMENT supplied Not applicable from a specified power supply Minimum requirements if limited space Not applicable for marking Name and or trademark of the See front page manufacturer or supplier Model or type reference See front page Rated supply voltage s or voltage 100 250 V Single phase a c range s Number of phases Type of current 3A Rated frequency or rated frequency 50 60 Hz range s in Hz Page 8 of 73 Nemko ref no 200043138 6 1 j Rated power input VA W or A 6 1k Power output of auxiliary mains socket No outlets 6 11 Class II symbol Not applicable Not Class ll Symbol for degree of protection with Ordinary equipment IP XO respect to harmful ingress of water according to EN 60529 IPX0 not required to be marked Symbol for protection against electric Personal Computer As the equipment is not intended to shock be connected to the patient and does not have any patient applied parts it is not marked with the type B applied part symbol Mode of operation if no marking Continuous operation suitable for continuous operation Types and rating of external accessible No external fuses fuses Rated output voltage and current or No auxiliary mains socket outlets power output frequency where applicable Symbol for physiological effect s Not applicable No need for marking oN Anaesthetic proof symbol Not
43. owed value Measured max Allowed value Measured max uA value uA uA value E Enclosure Enclosure leakage current current Patient leakage current p 1 c a c a a 100 10 Patient leakage current p 1 c d c ree 10 B BF 50 10 CF 50 P l c 110 of the mains voltage on the B 5000 113 signal input part or signal output part BF CF P 1 c 110 of mains voltage on the applied part Patient auxiliary current a c a 100 10 Patient auxiliary current d c a A 10 iia 10 PF The values listed are the maximum values Page 23 of 73 Nemko ref no 200043138 19 4 Tests after humidity preconditioning See comments below treatment uA value as uA value mew C 8 a E P 1 c 110 of the mains voltage on the 5000 signal input part or signal output part ae CF P l c 110 of mains voltage on the B applied part 10 Patient auxiliary current d c a Comments em The values listed are the maximum values Page 24 of 73 DIELECTRIC STRENGTH at operating temperature Equipment High voltage supply N1979 Initials Tester Date JohnyG 11 2000 under test resistance voltage al re es E a ee ee rr T S S y ae ovac 4oovac OK O a o e e E as Coo o T S a a E 250 V AC 4 000 VAC 250 V AC 4 000 VAC equipment A a2 gt o types Q O X 3 X Equipment types with applied part w gt Nemko ref no 20004313
44. page Refer to 20 3 Insulation Page 7 of 73 6 1d 6 le Nemko ref no 200043138 IDENTIFICATION MARKING AND DOCUMENTS Marking on the outside Example of marking label Markings of Mains operated C mgustrial Automation with PCS Fi4 No 108 3 Ming Chung Rd EQUIPMENT St ng Tien City Toipch Taiwan R O C e MADE IN TALWAN 2 MODEL PPC 150M FE Bb ruce ue me Basalt i h irmenta in part 15 of the FCC rile INPUT 100 250 Vac 3A Be Se E a aean sons ec is A mn aw ee er ay a a ene S N undesised operation i CAVON For contiaued fre pruiection replace aly with r and eating Bn ed a ere Egi i cat parts ina Refer servicing ta aualificd personnel l 2098012040 f Industrial Autamation with POS Fl No 108 3 Ming Chung Rd Shing Ticn City Taipei Taiwan ROC e MADE IN TAIWAN oe e a T wanted To Comply OO ee ak FE HEE emer on ics Wi i yar L5 of the FCC rule INPUT 100 250 Vac SA These romalea mia eean E O enes 50 60 H7 may mot erene harmful interference aad 2 this device must accepi 5 any interterence peceived including interference that may cause SIN undesired operation Ca utiOn ror cominved Sre protection replace only with Z50VFZA fwe of the specified type aad rating 1 TAL TAL To prevent cicetrie shock Do not remove cover Ho user sorviewble Egi cM paris inside Refer waving Io qualified personni 2098012040 Inqustrial automation with PCs 1 4 No 108 3 Ming Chung Rd H Shing Tien Ci
45. parts of fuseholders are shielded See above to prevent electric shock when replacing fuses if replaceable without the use of a tool Protective devices between an F type Not applicable No F type applied part applied part and the enclosure do not operate below 500 V r m s Oil containers in portable equipment are adequately sealed to prevent oil loss in any position and the oil container design allows for the expansion of oil Oil containers in mobile equipment are sealed to prevent loss of oil during transport An oil level indicator is provided on partially sealed oil filled equipment or parts Inspection of equipment and technical description and by manual Page 62 of 73 Nemko ref no 200043138 Fig 16 in Measurement of the earth leakage IEC 60601 1 current R seau Mains N L NC SI 1 SFC S1 0 Additional SFC see Clause 17 a S1 1 Measured uA Measured uA Measured uA 2 Metal enclosed 3 Combination of Insulation and metal enclosed and gt Z Before and after humidity preconditioning treatment Note NC Normal Conditions 1 Switch Closed describe additional SFC according to SFC Single Fault Condition 0 Switch Open Sub clause 17 a in notes above Page 63 of 73 Nemko ref no 200043138 APPENDIX 2 Fig 18 in Measurement of the enclosure FOR MAINS OPERATED EQUIPMENT IEC 60601 1 leakage current R seau Mains R seau Mains N L Switch position SFC S
46. pended masses devices Suspension systems include a safety device with adequate safety factors to protect user or patient from hazards If after activation of a safety device the equipment can still be used the activation of the device e g a secondary rope becomes obvious to the operator Suspension systems of metal without safety devices The construction of the suspension complies with Where it is unlikely that supporting characteristics will be impaired by wear corrosion material fatigue or ageing the SAFETY FACTOR of all supporting parts is not less than 4 Where impairment by wear corrosion material fatigue is expected the SAFETY FACTOR is not less than 8 Where metal having a specific elongation at break of less than 5 is used in supporting components the SAFETY FACTOR is not less than 1 5 times those given in 2 and 3 above The TOTAL LOAD does not exceed the SAFE WORKING LOAD Page 29 of 73 Nemko ref no 200043138 Sheaves sprockets band wheels and guides are so designed that the SAFETY FACTORS of this Sub clause shall be maintained for a specified minimum life till replacement of the ropes chains and bands Dynamic loads No general requirement a Diagnostic X ray equipment see IEC No X radiation 601 1 3 Radiotherapy equipment see relevant Particular standard For equipment not intended to produce X radiation for diagnostic and therapeutic purposes ionising radiation emitted by v
47. re rise for determination of the final temperature T Lo Model PPC 150M zT Page 32 of 73 Nemko ref no 200043138 Measuring point Measured Calculated Measured Calculated Allowed Remarks temp temp At K A IP 90Vac 60Hz B IP 275Vac 60Hz 1 Ambient T 25 C 2 L1 coil 3 BD1 body Table Xb Table Xb 4 C8 body 5 T1 coil Table Xb Table Xa Table Xa Table Xb Table Xb Table Xb Table Xb Table Xb Table Xb 13 F DD body Table Xb 14 CD rom body 27 52 52 Table Xb 7 12 SMP for building in Skynet SNP 8086 M See Nemko ref 200039133 Comments According to IEC 601 1 clause 42 1 table Xa and Xb 40 C or 25 C is added to the temperature rise for determination of the final temperature T P Model PPC 120M zT 6 T1 core 7 L4 coil 8 L3 coil 9 HS body of Q1 10 V36 body 11 cpu body 12 H DD body Page 33 of 73 Nemko ref no 200043138 Measuring point Measured Calculated Measured Calculated temp temp temp temp At K A IP 90Vac 60Hz B IP 275Vac 60Hz 1 Ambient T 25 C 2 L1 coil 3 BD1 body Q N N N Table Xb Table Xb 4 C8 body 5 T1 coil A S Table Xb Table Xa LI x a 4 Table Xa E I J a 4 E al J Ls Q On R 6 T1 core 7 L4 coil 8 L3 coil 9 HS body of Q1 10 BT1 body 11 V2 body Table Xb Table Xb Table Xb Table Xb Table Xb Q O w D a o nals A A N A N
48. ructions of the manufacturer causes no SAFETY HAZARD which could reasonably be fore seen and which is not connected with its intended application in NORMAL CONDITION and in S F C An alternative means of construction is used to that detailed in this standard and it can be demonstrated that an equivalent degree of safety is obtained Nemko ref no 200043138 The equipment causes no hazards when used according the manufacturers instructions No alternative construction CLASSIFICATION Type of protection against electric Class equipment shock Degree of protection against electric shock Degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or WITH OXYGEN OR NITROUS OXIDE No applied part This is a Personal Computer As the equipment is not intended to be connected to the patient and does not have any patient applied parts it is not marked with the type B applied part symbol The equipment is not an AP or APG category equipment Page 5 of 73 Nemko ref no 200043138 si INSULATION DIAGRAM Protection against electric shock Refer to table on next page Block diagram of system Page 6 of 73 Nemko ref no 200043138 Si TABLE TO INSULATION DIAGRAM ON PREVIOUS PAGE E Distance Insulation type Maximum Required distances mm Dielectric strength Test Refer to 20 1 20 2 Basic Supplement circuit test voltage Double Reinforced voltage Clearance Cree
49. s and 2 are Line and Neutral supply pins Note PE is equal to enclosure Measurement no Voltage between pins and 2 Limit 60 V Voltage between pin and PE Limit 60 V Voltage between pin 2 and PE Limit 60 V Accessible live parts of capacitors or Not applicable related circuits having a residual voltage above 60 V does not have a residual energy above 2 mJ see 15 c below A non automatic discharging device is included and marked C Capacitor and its location Working voltage Capacitance value Residual voltage Residual energy V mF V mJ Page 18 of 73 Nemko ref no 200043138 Instruction for use instructs operator Not applicable No such parts not to touch such parts and the patient simultaneously Initials Tester Date oR ee es oo ee Sa 16b Check of openings in top covers with No openings in the top covers the vertical suspended test rod 16c Conductive parts of actuating Not applicable mechanism of electrical controls after the removal of handles knobs levers etc have either resistance to the protective earth terminal max 0 2 ohms or the separation from live parts complies with 17 g Protection of contact with internal parts Not applicable of the equipment with a circuit voltage exceeding 25 V a c or 60 V d c which cannot be disconnected from the supply by external mains switch or plug device Protective enclosures are removable Only with the aid of tool only with
50. sed of warning symbols are provided in accompanying documents Language of accompanying documents English Will be in the language required for the market where the equipment is intended to be sold Page 12 of 73 Nemko ref no 200043138 Instructions for use General information Necessary information to operate the equipment Explanation of the function of controls displays and signals Sequence of operation Connection and disconnection of Detachable power supply cord detachable parts and accessories Replacement of material which is Not applicable consumed during operation Indications of recognised accessories Not applicable detachable parts and materials if the use of other parts or materials can degrade minimum safety Cleaning preventive inspection and User Manual maintenance to be performed including the frequency of such maintenance Information about safe performance of routine maintenance Information about preventive inspection and maintenance to be performed by other persons Instruction for use states the function and intended application of equipment Meanings of figures symbols warning statements and abbreviations on equipment explained in the instructions for use Instructions for use provide user with Not applicable information regarding potential electromagnetic or interference and advice how to avoid such interference Signal output or signal input parts Not applicable inte
51. ter min 2 0 mm thick UL UL CD rom TUV CSA XM 7004Bxx 5Vdc 0 9A Optional UL XM 1902Bxx X 0 9 Appliance VDE Supercom SC 9 10A 250Vac inlet Inalways 0711 Rong Feng SS 130 Rong Feng SS 7B Mains fuse UL CSA Conquer GBP 12A 250Vac System General PDC60240 A0 I P 24Vdc 5 0A Conquer GFP O P 7A 250Vac UL I L F VDE CSA Fima 1852 5A 250Vac Lithium SGS Thomson M4T28 BR12SH1 5V 50mAh Battery Ply switch UL TUV Raychem SMD150 2018 1 10A 5V for Keyboard mouse DC fan for VDE CSA Delta AFB0512MA 12Vdc 0 15A CPU U 8 47CFM Inverter Accept Sen Huei TRN 0067 and TRN 0064 CI B transformers tested in TDK SRW15 20EM T11H004 equipment NIA15 20EM T1 1H004 Mains See Nemko Adaptor Skynet SNP 8086 M transformer ref No 200039133 DC fan for Adda AD0412MB G70 12Vdc 0 08A DC power 4 2C0GM supplies LCD module Accept Samsung LT150Z 051 TFT type 6V for model tested in max for iput PPC xxM zT equipment 11 2mA 690V for lamp Toshiba LTM15C151A TFT type 5V max for iput 6mA 710V for lamp Inverter for Accept Laruel Carry amp Leap TAD282 12V 1 14A Le tested in equipment Page 47 of 73 Nemko ref no 200043138 Marking of components refer to Table in Clause 56 Component markings are according The components are used according to their ratings All with conditions of use components in the mains part and applied part are marked or otherwise identified regarding their ratings 56
52. th sharp against sharp edges etc corners and edges are protected by additional fixed sleeving or similar means if there is movement relative to metal parts where it is in direct contact with metal parts and wiring cord forms or components are not likely to be damaged by opening or assembling the equipment or opening or closing of inspection doors Page 60 of 73 Nemko ref no 200043138 The bending radius of cables and cable Not applicable forms is at least 5 times the outer diameter of the lead insulating sleeving is adequately secured It can only be removed by breaking or cutting or is secured at both ends Sheath of a fle xible cord used as Not applicable supplementary insulation inside equipment is not subject to undue mechanical or thermal stresses and its insulation properties are at least as specified in IEC 60227 or IEC 60245 insulated conductors which are Not applicable No temp over 70 deg C subject to temperatures greater than 70 C have an insulation of heat resistant material Dielectric strength test of insulation of 2000 V for 1 min 59 1d Aluminium wires below 16 mm cross Not used section are not used 59 1 f Connecting cords between equipment Not applicable No such connection parts e g parts of an xray or patient monitoring installation or a data processing installation or combinations are considered belonging to equipment and subject to requirements of this stan
53. ting or reference stated GBP 12A 250Vac Protective earth terminal TAE O Terminals for supply neutral conductor in permanently installed equipment marked N The supply connections are clearly marked adjacent to the terminals or in accompanying documents for small equipment Statement for suitable wiring materials Not applicable at temperatures over 75 C locates at or near the point of the supply connections and is clearly discernible after connection Capacitors and or circuit parts are Not applicable marked as required in Sub clause 15 c Mains switch clearly identified On and off positions marked or otherwise indicated Adequate indications of different Not applicable positions of controls and other switches Adequate indication of the direction of setting devices if change of setting of a control could cause a safety hazard Functions of operator controls and indicators identified Numeric indications of parameters are in SI units according to ISO 1000 Units outside the International System as specified Symbols Marking symbols compliance with appendix D where applicable Page 10 of 73 Nemko ref no 200043138 Symbols for controls and performance Not applicable conform to IEC 60 878 where applicable a Durability of marking symbols Tested in Clause 6 1 P Colours of insulation of conductors 65a Protective earth conductor has green yellow insulation All insulati
54. tion Page 57 of 73 Nemko ref no 200043138 An earthed screen has a minimum overlap of Not used 3 mm and a width at least equal to the axial length of the primary winding The insulation between the primary and secondary winding in reinforced or double insulated transformers consists of combination of two layers withstands Test voltage 4000Vac dielectric strength test for reinforced insulation The creepage distances between the primary See Sub clause 57 9 4 e and secondary windings comply with requirements for reinforced insulation with specified allowances am wbexion For toroidal transformers Not applicable SMP used the exit of wires from internal windings is provided with double sleeving complying with requirements for double insulation its total thickness is at least 0 3 mm extending at least 20 mm outside the winding Measured thickness Page 58 of 73 Nemko ref no 200043138 57 10 a Values refer to table Creepage distances and air clearances comply at least with the values of Table XVI Creepage distances for slot insulation of No motor used motors are at least 50 of the values in the table with a minimum of 2 mm at 250 V Creepage distances and air clearances No defibrillation proof applied parts between defibrillation proof applied parts and other parts are not less than 4 mm Insulation Ref Air clearance mm Creepage distance mm Notes voltage between V Required Measur
55. ty Taipei Taiwan R O C amp MADE IN TAIWAN a reee er ee FE EREE ener vu INPUT 100 250 Vae JA This device compline with the requitoitata in pan 15 of the FOC mule 50 60 Hz Operation is subject to the following o conditons 1 this device S i may aul come hartnhol interference pus 7 this device must coepti 3 i For continued Gre protection yeplace andy with Caution vndlciwred operation S N any interference received including inicuference thot may tiuse 250 V FLA fuse of the specified type and rating SAL AL To preveni cicctric shock Do not remawe cover No uses jervicenble C CHAI parts inside Retes sewieing to qualified personnel 2098012040 Taura Fe Comply MODEL PPC 123M FE Be tence ose INPUT 100 250 Vae JA this device complies with the requainenisin pan sa the Teens Hz in mubjeet 0 the haveing ine Pane q9 A 4 harmful mieuierence ans 50 6 may mot CE eee thal may ense unnerired mper ation S N anp witertcretee Caution ror cootimued fire protection replace only with JSOVIELA fuse of Ue speci Ged ype and ratin t To prevent electric shock Diy not romowe cover Wo user weeviceable be a om pany ipda Belge sensiring ta qualified personnel x pies ia if industrial Automation with PGs F14 No 108 3 Ming Chung Rd Shing Tien City Taipei Taiwan RO a MADE IN TAIWAN i a a ee arn ea A Markings of Internally Powered Not applicable N
56. values specified in Sub clause 57 10 Not possible to push the cord into equipment to such an extent that the cord or internal parts of the equipment could be damaged For other than stationary equipment the power supply cord is adequately protected against excessive bending by means of a cord guard of insulating material Alternatively shaped opening for the power supply cord Bending test Flexing test if guards fail the dimensional test see IEC 60335 1 AM 6 1988 Sub clause 25 10 Results of flexing test Percent of broken conductor strands After the tests the cord sheath has not been longitudinally displaced by more than 2 mm and the conductor ends have not moved over Page 53 of 73 Nemko ref no 200043138 There is sufficient space inside the equipment to allow the supply cable conductors to be introduced and connected Any covers can be fitted without risk of damage to the conductors or their insulation It is possible to check that conductors are correctly connected before the cover is fitted Mains Terminal Devices and wiring of mains part Mains connected equipment other than those Not applicable Detachable supply cord used with a detachable supply cord is provided with mains terminals where connections are made with screws nuts soldering clamping crimping of conductors or equally effective methods Reliance not placed upon terminals alone to maintain conductors in position unless

TEST REPORT MEDICAL ELECTRICAL EQUIPMENT

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