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(2006) + CORR. 2 - Vogel Business Media

1. 15 4 3 4 RM RESULTS TABLE Lithium batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information 15 4 3 5 RM RESULTS TABLE Excessive current and voltage protection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 15 4 4 RM RESULTS TABLE Indicators N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product No indicators provided 15 4 5 RM RESULTS TABLE Pre set controls N A TRF No IEC60601_1G SI gt Page 207 of 279 Report No T223 0330 12 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No pre set controls provided 15 4 6 TABLE actuating parts of controls of ME EQUIPMENT torque amp axial pull tests N A Rotating control Gripping Torque from Axial force Unacceptable Remarks under test diameter
2. Zhejiang LECI DB 6 250 Vac 2 5 A IEC EN VDE 40032465 Electronics Co eee 60320 1 Ltd P C6 AXUT2 UL E302229 Sun Fair Electric S 02 250 Vac 2 5 A IEC EN VDE 40034448 Wire amp Cable 3 pins 60320 1 O Oneal tee AXUT2 UL E226643 Shenzhen CDJ 2 250 Vac 2 5A IEC EN VDE 40015580 Delikang 3 pins 60320 1 Electonics AXUT2 UL E217394 Technology Co C6 Ltd Bridging TDK CD Min 250 Vac IEC EN VDE 138526 capacitor Max 1000pF 60384 14 CY1 Min Y1 FOWX2 UL E37861 SUCCESS SE Min 250 Vac IEC EN VDE 40008996 hae Co Max 1000pF 60384 14 i Min Y1 FOWX2 UL E114280 JYA NAY Co JN Min 250 Vac IEC EN VDE 40001831 Etd Max 1000pF 60384 14 UL 201384 Min Y1 FONR Haohua CT7 Min 250 Vac IEC EN VDE 40003902 Electronic Co Max 1000pF 60384 14 Min Y1 FOWX2 UL E233106 Welson WD Min 250 Vac IEC EN VDE 40016157 Max 1000pF eyes Min Y1 FOWX2 UL E104572 CHYUN FUH cD Min 250 Vac IEC EN VDE 40001223 TEAN Co Max 1000pF 60384 14 Min Y1 FOWX2 UL E202835 Murata Mfg Co KX Min 250 Vac IEC EN VDE 40002831 Ltd Max 1000pF 60384 14 Min Y1 FOWX2 UL E379921 ZHI WEI DJ Min 250 Vac IEC EN VDE 40032789 ia Co Max 1000pF 60384 14 i Min Y1 FOWX2 UL E330260 TRF No IEC60601_1G SI Page 159 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Shantou High CD Min 250 Vac IEC EN VDE 40025754 T A Maxtooopp 038414 Z
3. TRF No IEC60601_1G SLE Page 155 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark TABLE List of critical components P O Component Manufacturer Type Technical data Standard Mark s amp Part No Trademark No model No No Edition Certificates of conformity Enclosure Tejin Chemicals LN 1250P Min 94V 0 at min 1 5 IEC EN Accepted Sraa LN 1250G mm thickness 60601 1 fire f Overall approx 86 5 QMFZ2 UL E50075 by 47 by 32 mm GTM21089 Desk top Min 2 3 mm thick version 125 C Constructed of two parts secured together by ultrasonic welding SABIC SE1X Min 94V 1 at min 1 5 IEC EN Accepted Innovative mm thickness 60601 1 Plastics SFI SE100 Overall approx 86 5 QMFZ2 UL E45329 by 47 by 32 mm PES00R Min 2 3 mm thick CX7211 95 C ERE TOOS Constructed of two parts secured together by ultrasonic welding Printed Various Various Min UL94 V0 ZPMV2 UL approved circuit board Min 130 C PCB X Capacitor Pilkor PCX2 Min 250 Vac IEC EN SEMKO CX1 ee Co Max 0 22 uF 60384 14 SE 0256 1 Min X2 or X1 FOWX2 UL E165646 Ultra Tech Xiphi HQX Min 250 Vac IEC EN VDE 40024534 had Co Max 0 22 uF 60384 14 Min X2 or X1 FOWX2 UL E183780 Ultra Tech Xiphi UTX Min 250 Vac IEC EN VDE 40023119 Max 0 22 uF elses Min X2 or X1 FOWX2 UL E183780 Dain Electronics MPX Min 250 Vac IEC EN VDE 40018798 Co Ltd Max 0 22 uF 60384 14 Min
4. Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary information No such connectors provided 15 4 2 1a RM RESULTS TABLE thermal cut outs and over current releases N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information No such control devices incorporated 15 4 2 1b RM RESULTS TABLE THERMAL CUT OUTS with a safety function N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information No thermal cut out incorporated 15 4 2 1c RM RESULTS TABLE Independent non SELF RESETTING THERMAL CUT OUT N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information No thermal cut out incorporated 15 4 2 1d RM RESULTS TABLE Loss of function of ME EQUIPMENT N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 TRF No IEC60601_1G SIS Page 205 of 279 Report No T223 0330 12 15 4 2 1d RM RESULTS TABLE Loss of function of ME EQUIPMENT N E Clause of Document Ref in RMF Result
5. SLED Page 146 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark ME EQUIPMENT with an APPLIANCE INLET impedance between earth pin in the APPLIANCE INLET and a PROTECTIVELY EARTHED part 25A 60 sec 0 068 2 8 100 ME EQUIPMENT with an APPLIANCE INLET impedance between earth pin in the APPLIANCE INLET and a PROTECTIVELY EARTHED part 40A 120 sec 0 143 3 6 100 ME EQUIPMENT with a non DETACHABLE POWER SUPPLY CORD impedance between the protective earth pin in the MAINS PLUG and a PROTECTIVELY EARTHED part 200 Supplementary information Relevant only for models with protective earth Measured between PE pin of appliance inlet and internal protective earth connection 8 7 TABLE leakage current Type of leakage current and test he een condition including single faults V Hz y Measured max value HA Remarks Fig 13 Earth Leakage ER Maximum allowed values 5 mA NC 10 mA SFC Model GTM21089 se ries Normal condition normal polarity 264 60 93 2 Measured on desk top before humidity treatment version with protective earth Normal condition reverse polarity 264 60 93 2 Measured on desk top before humidity treatment version with protective earth Single fault condition supply 264 60 138 9 Measured on desk top interruption normal polarity before version
6. 1 PCB near D4 2 Optical insulator U1 3 Capacitor C9 4 T1 winding 5 T1 core 6 PCB near to Q2 7 PCB near to Q3 8 Capacitor C2 9 PCB near to D8 10 Inductor LF1 11 Case top 12 Case bottom 13 PCB 14 Inside enclosure Input current A Output voltage Vdc Output current A Duration min Supplementary information Temperature rises of the transformer was measured with thermocouples Class B transformer provided inside the unit 130 C 10 C 120 C Inductor NF1 and L1 are assumed to be Class A 105 C 10 C 95 C The printed circuit board PCB is rated 130 C Max temperature determined in accordance with 11 1 3e 1 Plastic enclosure of the EUT is assumed to be touched by the operator for a time t t lt 1 second therefore limit 86 C applied for external plastic enclosure Power supply unit is not intended to be moved from one to another location during operation Test performed on desk top power supply unit to cover all versions TRF No IEC60601_1G SI gt Page 182 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 1 1 TABLE Thermal requirements Model GTM21089 1824 24 0 Vdc 0 75 A Maximum measured temperature T of Max measured temperature C Allowe part at d Tmax C 1 PCB near D4 2 Optical insulator U1 3 Capacitor C9 4 T1 winding 5 T1 c
7. Requirement Test Result Remark Appliance Rich Bay R 301SN 250 Vac 10A IEC EN VDE 40030228 inlet Company Ltd 3 pi 60320 1 pins for models AXUT2 UL E184638 with C14 protective earth for GTM 21089 T3 models only SUPERCOM SC 8 250 Vac 10A IEC EN VDE 40014286 Electronics Co 60320 1 Ltd 3 pins C14 AXUT2 UL E152973 TECX Unions TU 301 SP 250 Vac 10 A IEC EN VDE 40025582 Technology 60320 1 Corp nigh AXUT2 UL E220004 C14 Rong Feng SS 120 250 Vac 10A IEC EN VDE 40028101 Industrial Co 60320 1 ctd a AXUT2 E102641 C14 ARUTAN NOE Zhejiang LECI DB 14 250 Vac 10A IEC EN VDE 40032008 Electronics Co P 60320 1 Pe aie AXUT2 E30222 C14 AXUT2 UL E302229 Sun Fair Electric S 03 250 Vac 10 A IEC EN VDE 40034447 Wire amp Cable 3 pins 60320 1 HK Co Ltd E C14 AXUT2 UL E226643 Shenzhen CDJ 3 250 Vac 10A IEC EN VDE 40010513 Delikang 3 pins 60320 1 Electronics 3 Technology Co C14 AATA REAR Ltd Appliance Rich Bay R 30790 250 Vac 2 5 A IEC EN VDE 40030381 inlet Company Ltd 3 pi 60320 1 pins for models AXUT2 UL E184638 f C6 with protective earth for GTM 21089 T3A models only TECX Unions TU 333 250 Vac 2 5 A IEC EN VDE 40005430 Technology 60320 1 Corp ise AXUT2 UL E220004 TRF No IEC60601_1G SLE Page 158 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark
8. ME EQUIPMENT components and general assembly TRF No IEC60601_1G SI Page 107 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Incorrect connection of accessible connectors See Appended RM Results removable without a TOOL prevented where an Table 15 4 1 unacceptable RISK exists in particular Output cable is soldered to the PCB through the hole within the equipment by the manufacturer In additional cord anchorage used for secondary cable See enclosed pictures of the unit for details End product consideration for open frame and PCB mounted version a Plugs for connection of PATIENT leads cannot See attachment be connected to other outlets on same ME EQUIPMENT intended for other functions except when RISK MANAGEMENT FILE provides proof that no unacceptable RISK could result No patient leads provided b Medical gas connections on ME EQUIPMENT See attachment for different gases to be operated in NORMAL USE are not interchangeable as verified by review of RISK MANAGEMENT FILE ssseccseeeeeeeees No medical gas connections provided a THERMAL CUT OUTS and OVER CURRENT See Appended RM Results RELEASES with automatic resetting not used in Table 15 4 2 1 a ME EQUIPMENT when their use could result in a HAZARDOUS SITUATION by resetting action as verified by review of RISK MANAGEMENT FILE No such components incorpora
9. End product consideration for open frame and PCB mounted version no external enclosure provided 5 9 2 3 RM RESULTS TABLE Actuating mechanisms N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information No such parts 7 1 2 TABLE Legibility of Marking P Markings tested Ambient illuminance Remarks Ix Outside Markings Clause 7 2 sss0 100 1500 Ix Marking plate Inside Markings Clause 7 3 sasssa No markings to be read inside TRF No IEC60601_1G SI Page 135 of 279 Report No T223 0330 12 7 1 2 TABLE Legibility of Marking P Controls amp Instruments Clause 7 4 No controls amp instruments Safety Signs Clause 7 5 ccceeessseerens No safety signs Symbols Clause 7 6 ssecccssseeeeeeeeeens 100 1500 Ix Present on Marking plate Supplementary information Observer with a visual acuity of 0 on the log Minimum Angle of Resolution log MAR scale or 6 6 20 20 reads marking at ambient illuminance least favourable level in the range of 100 Ix to 1 500 Ix The ME EQUIPMENT or its part was positioned so that the viewpoint was the intended position of the OPERATOR at any point within the base of a cone subtended by an angle of 30 to the axis normal to the
10. Oxygen concentration sassa UCM aievcaticaceecteenpecetiedeectienteccteeneeretires Current A cs cccseceeeeseeeeseeeeseeeeeneees Voltage V secccsecceseeeeseeeeseeneseeeeseeeeee Capacitance F seccsssssesensenees Inductance or resistance h or Q No of trials 300 Min cseeseeen Sparks resulted in ignition Yes No TRF No IEC60601_1G SI gt Page 187 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information Test procedure of 11 2 2 1 a 5 amp Figs 35 37 used for tests For circuits not in Figs 35 37 test voltage or current set at 3 times the worst case values with other parameters set at worst case values to determine if ignition can occur 11 3 RM RESULTS TABLE Constructional requirements for fire enclosures of ME N A equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 11 5 RM RESULTS TABLE ME equipment and ME systems intended for use in N E conjunction with flammable agents Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information The
11. Requirement Test Result Remark Emission of flames molten metal poisonous Not occur during single fault or ignitable substance in hazardous quantities did not occur Deformation of ENCLOSURE impairing No deformation of the compliance with 15 3 1 did not occur enclosure occurs Not applicable for open frame and PCB mounded version no external enclosure provided Temperatures of APPLIED PARTS did not See appended Tables 11 1 1 exceed allowable values in Table 24 when 11 1 2 1 and 11 1 2 2 measured AS in 11 1 3 cccccesessseceeeeeeeeeseesneeeeee No applied parts provided Temperatures of ME EQUIPMENT parts that are See appended Tables 11 1 1 not APPLIED PARTS likely to be touched did not 11 1 2 1 and 11 1 2 2 exceed values in Table 23 when measured and adjusted AS in 11 1 3 ceeseeeeeessseeeeeeeeteeseeteeneees Allowable values for other components and Considered materials in Table 22 times 1 5 minus 12 5 C were not exceeded Limits for windings in Tables 26 27 and 31 not Temperature of transformer exceeded windings not exceeded Table 22 not exceeded in all other cases Se Temperatures measured according to 11 1 3 SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 and Single faults performed 13 2 2 relative to emission of flames molten metal or ignitable substances not applied to parts and components where EUT is provided with plastic enclosure without openings made
12. TRF No IEC60601_1G SI gt Page 114 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark instructions for cleaning and when N A applicable disinfecting and sterilizing each item of equipment or equipment part forming part of the ME SYSTEM additional safety measures to be applied N A during installation of ME SYSTEM identification of parts of ME SYSTEM suitable N A for use within the PATIENT ENVIRONMENT additional measures to be applied during N A preventive maintenance a warning forbidding placement of MULTIPLE N A SOCKET OUTLET when provided and it is a separate item on the floor a warning indicating an additional MULTIPLE N A SOCKET OUTLET or extension cord not to be connected to ME SYSTEM a warning to connect only items that have N A been specified as part of ME SYSTEM or specified as being compatible with ME SYSTEM maximum permissible load for any MULTIPLE N A SOCKET OUTLET S used with ME SYSTEM instructions indicating MULTIPLE SOCKET N A OUTLETS provided with the ME SYSTEM to be used only for supplying power to equipment intended to form part of ME SYSTEM an explanation indicating RISKS of connecting N A non ME EQUIPMENT supplied as a part of ME SYSTEM directly to wall outlet when non ME EQUIPMENT is intended to be supplied via a MULTIPLE SOCKET OUTLET with a separating transformer an explanation indicating RISKS of connecting N A any equip
13. b Contribution to CREEPAGE DISTANCES of Considered grooves or air gaps less than 1 mm wide limited to widths c Relative positioning of CLEARANCE providing a MEANS OF PROTECTION is such that the relevant parts are rigid and located by molding or there is no reduction of a distance below specified value by deformation or movement of parts TRF No IEC60601_1G 8 9 1 15 CREEPAGE DISTANCES and AIR CLEARANCES for No applied parts provided SI Page 63 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Normal or likely limited movements of relevant parts taken into consideration when calculating minimum AIR CLEARANCE Spaces filled by insulating compound N A Only solid insulation requirements applied No parts filled with N A where distances between conductive parts insulation compounds filled with insulating compound were such that CLEARANCES and CREEPAGE DISTANCES don t exist There are only approved optocoupler connected between primary and secondary circuit See list of critical components Thermal cycling humidity preconditioning and dielectric strength tests in 8 9 3 2 and 8 9 3 4 or 8 9 3 3 and 8 9 3 4 conducted For insulating compound forming solid See appended Table 8 9 3 2 insulation between conductive parts a single sample subjected to thermal cycling PROCEDURE of 8 9 3 4 followed by humidity preconditioning per 5 7 for 48 hours followed by dielectric strength test c
14. 100 uA NC 500 uA SFC a c Type CF AP 10 uA NC 50 uA SFC d c or a c current Fig 16 Patient leakage current with mains on the F type applied parts PM Maximum allowed values Type B N A Type BF AP 5000 uA Type CF AP 50 uA Fig 17 Patient leakage current with external voltage on Signal Input Output part SIP SOP Maximum allowed values Type B or BF AP 10 uA NC 50 uA SFC d c current 100 uA NC 500 uA SFC a c Type CF AP 10 uA NC 50 uA SFC d c or a c current TRF No IEC60601_1G v i Page 149 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Fig 18 Patient leakage current with Maxim mallowed values external voltage on metal Accessible Type B or BF AP 500 uA Part that is not Protectively Earthed Type CF N A Maximum allowed values Type B or BF AP 10 uA NC 50 uA SFC d c current 100 uA NC 500 uA SFC a c Type CF AP 10 uA NC 50 uA SFC d c or a c current Fig 19 Patient Auxiliary Current Maximum allowed values b 4 Type B or BF AP 50 uA NC Fig 15 and 20 Total Patient 100uA SFC d c current Leakage Current with all AP of same type connected together 500 uA NC 1000 uA SFC a c Type CF AP 50 uA NC 100 uA SFC d c or a c current Maximum allowed values Fig 17 and 20 Total Patient Type B or BF AP 50
15. Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 Supplementary information The risk management requirements of the standard were not addressed End product consideration 15 4 2 1h RM RESULTS TABLE ME EQUIPMENT with tubular heating elements N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information 15 4 3 1 RM RESULTS TABLE Housing N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information 15 4 3 2 RM RESULTS TABLE Connection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information 15 4 3 3 RM RESULTS TABLE Protection against overcharging N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 TRF No IEC60601_1G SI gt Page 206 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 15 4 3 3 RM RESULTS TABLE Protection against overcharging N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary information
16. 13 2 13 3 ME EQUIPMENT with motors N A a 1 For the motor part of the ME EQUIPMENT No motors provided N A compliance checked by tests of 13 2 8 13 2 10 13 2 13 3 b 13 2 13 3 c and 13 2 13 4 as applicable a To determine compliance with 13 2 9 and 13 2 10 motors in circuits running at 42 4 V peak a c 60 V d c or less are covered with a single layer of cheesecloth which did not ignite during the test TRF No IEC60601_1G SI Page 99 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark a 2 Tests on ME EQUIPMENT containing heating N A parts conducted at prescribed voltage with motor amp heating parts operated simultaneously to produce the least favourable condition a 3 Tests performed consecutively when more N A tests were applicable to the same ME EQUIPMENT b Motor met running overload protection test of this clause when 1 it is intended to be remotely or automatically controlled by a single control device with no redundant protection or 2 it is likely to be subjected to CONTINUOUS N A OPERATION while unattended Motor winding temperature determined during N A each steady period and maximum value did not exceed Table 27 Insulation Class Maximum temperature measured C sssssssssssserennnerennnne Motor removed from ME EQUIPMENT and tested N A separately when load could not be changed in appropriate steps Running overload test for motors operating at N A 42 4 V peak
17. 14 6 1 RM RESULTS TABLE Identification of known and foreseeable hazards N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 Supplementary information 14 6 2 RM RESULTS TABLE Risk control N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 1 TRF No IEC60601_1G SIS Page 200 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information 14 7 RM RESULTS TABLE Requirement specification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 Supplementary information 14 8 RM RESULTS TABLE Architecture N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 Supplementary information 14 9 RM RESULTS TABLE Design and Implementation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 6 3 Supplementary information 14 10 RM RESULTS TABLE Verification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 Supplementary information 14 11 RM RESULTS TABLE PEMS validat
18. 28 V Auto Max C1 vente T1 Pin 3 to Pin 6 YOKOGAWA 2011 10 19 21 09 22 Stopped 32 33 Min C1 352 V P P C1 385 V Rms C1 212 522 Y 159 647 Y Freq C1 49 89024 Hz Normal 4 1 25MS s Edge CH1 F 132 Auto KT 200 Vav KD 200 Vait fao v Main 125 k fi i j i i j j L H g0 v 50 00ms 10ms div i i i i i i i i i i 50 00ms Main 125 k 10ms div h j f t800 v 150 00ms Max C1 vee U1 Pin 1 to Pin 3 YOKOGAWA 2011 10 19 20 09 33 Stopped 42 Min C1 455 Y P P C1 665 Y Freq G1 49 76511 Hz q Rms C1 224 224 Y Edge CH1 F 57 V Auto Max C1 Wear U1 Pin 1 to Pin 4 YOKOGAWA 2011 10 19 20 10 05 Stopped 30 Min C1 296 Y 480 V P P C1 T6 Y Rms C1 246 277 V 154 089 Y Freq C1 51 26102 Hz Normal 4 625kS s Edge CH1 57 Y Auto KO 8T Vativeltt D 8I Vaw Bzz v Main 125 k 74 v 100 0ms 20ms div 1 i i i i i i i i i i i i i i i i i i i i i i i i 100 0ms 522 V Main 125 k 20ms div 100 0ms Max C1 Min C1 Mean C1 me P P GI Fret ep 363 Y 31 Y 184 336 V TRF No IEC60601_1G Rms C1 229 247 Y Max C1 P P C1 Rms C1 220 989 Y Mean C1 360 Y Min C1 BAJ 114 287 Freq C1 49 97601 Hz SI gt Page 22 of 279 Report No T223 0330 12 IEC 60601 1 Requir
19. Intentional exceeding of safety limits N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 12 4 2 RM RESULTS TABLE Indication of parameters relevant to safety N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No energy delivered to the patient 12 4 3 RM RESULTS TABLE Accidental selection of excessive output values N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 TRF No IEC60601_1G SI gt Page 192 of 279 Report No T223 0330 12 12 4 3 RM RESULTS TABLE Accidental selection of excessive output values N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 12 4 4 RM RESULTS TABLE Incorrect output N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information EUT is power supply unit with singl
20. National standard ANSI AAMI ES60601 1 2005 National standard SN EN 60601 1 06 Summary of compliance with National Differences See enclosure No 1 for details US NATIONAL DIFFERENCES to IEC 60601 1 Third edition CANADA NATIONAL DIFFERENCES to IEC 60601 1 Third edition National standard CAN CSA C22 2 No 60601 1 08 SWITZERLAND NATIONAL DIFFERENCES to IEC 60601 1 Third edition TRF No IEC60601_1G SIS Page 7 of 279 Report No T223 0330 12 Copy of marking plate The artwork below may be only a draft The use of certification marks on a product must be authorized by the respective NCBs that own these marks a GTM21089 YYZZ A B T3 Safety Class power supply unit GlobTek Inc i POWER SUPPLY FOR MEDICAL USE PART NO MODEL GTM21060 WWVV T3 INPUT 100 2400 abp 0 5 0 254 OUTPUT W WEDT A ACHE R E oeo O a MADE IN XXXX b GTM21089 YYZZ A B T2 Safety Class Il power supply unit GlobTek Inc GS POWER SUPPLY FOR MEDICAL USE PART ND MODEL GTM21069 Ww V T2 INPUT 100 240V 50 rig 0 5 O25A OUTPUT gt Va ACE A E cuate E ER coe Ss m ADE I XXXX c GTM21096 YYZZ A B F Power supply unit intended for building in safety class not defined 3 GlobTek Inc S MEDICAL POWER SUPPLY PART NO MODEL GTM21006 WWVV F INPUT 100 240 50 G0Rz 0 5 0 254 OUTPUT V zva A AY CE O SE fl AD DA x RoHS ware Dox Be Et am TRF No
21. Other Conditions N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary Information Maximum ambient temperature 40 C specified by the manufacturer The risk management requirements of the standard were not addressed 5 7 RM RESULTS TABLE Humidity preconditioning treatment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 TRF No IEC60601_1G SI gt Page 134 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 5 7 RM RESULTS TABLE Humidity preconditioning treatment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 5 Supplementary Information Standard humidity treatment performed as declared by the manufacturer Power supply unit is intended for indoor use only 5 9 2 TABLE Determination of ACCESSIBLE parts P Location Determination method NOTE1 Comments Power supply enclosure Visual Live parts not accessible Enclosure without openings provided to cover all live parts No doubts therefore only visual inspection performed Supplementary information NOTE 1 The determination methods are visual rigid test finger jointed test finger test hook
22. PATIENT CONNECTIONS 2 3 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 2 or APPLIED PART with PATIENT CONNECTIONS 1 3 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 3 or APPLIED PART with PATIENT CONNECTIONS 1 2 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 4 or APPLIED PART with PATIENT CONNECTIONS 1 2 and 3 of the same APPLIED PART connected to earth No applied parts provided Supplementary information For compliance E1 must at least 90 of E2 E1 Measured energy delivered to 100 Q with ME Equipment connected E2 Measured energy delivered to 100 Q without ME equipment connected 8 6 3 RM RESULTS TABLE Protective earthing of moving parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information No moving parts provided 8 6 4 TABLE Impedance and current carrying capability of PROTECTIVE EARTH P CONNECTIONS Type of ME EQUIPMENT amp impedance Test current Voltage drop Maximum Maximum measured between parts A measured calculated allowable Duration s between impedance impedance parts V mQ mQ PERMANENTLY INSTALLED ME EQUIPMENT 100 impedance between PROTECTIVE EARTH TERMINAL and a PROTECTIVELY EARTHED part TRF No IEC60601_1G
23. Supplementary Information The risk management requirements of the standard were not addressed All applicable single fault conditions performed according to the standard 4 8 RM RESULTS TABLE Components of ME Equipment N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 TRF No IEC60601_1G SI gt Page 131 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 4 8 RM RESULTS TABLE Components of ME Equipment N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary Information IEC approved components provided within the unit The risk management requirements of the standard were not addressed See list of critical components for details 4 9 RM RESULTS TABLE Use of components with high integrity characteristics N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information The risk management requirements of the standard were not addressed Approved components provided between primary and secondary circuit Refer to List of critical components TABLE Power Input Voltage Frequency Current Power fac
24. Supplementary information No rough surfaces no sharp corners and no sharp edges 9 4 2 1 TABLE Instability overbalance in transport position N A ME EQUIPMENT Test Condition transport position Remarks preparation Supplementary information TRF No IEC60601_1G SIS Page 170 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 9 4 2 2 TABLE Instability overbalance excluding transport position N A ME EQUIPMENT Test Condition excluding transport Remarks preparation position Test either 5 incline and verify Warning marking or 10 incline Supplementary information 9 4 2 3 TABLE Instability overbalance from horizontal and vertical forces N A ME EQUIPMENT Test Condition force used direction of Remarks preparation force weight of equipment location of force Supplementary information 9 4 2 4 2 TABLE Castors and wheels Force for propulsion N A ME EQUIPMENT Test Condition force location and height Remarks preparation Supplementary information 9 4 2 4 3 TABLE Castors and wheels Movement over a threshold N A ME EQUIPMENT Test Condition speed of movement Remarks preparation Supplementary information 9 4 2 4 3 RM RESULTS TABLE Movement over a threshold N A Clause of Document
25. TRF No IEC60601_1G SI Page 77 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Assessment criteria in Clause 9 and 11 6 N A used IA Dielectric strength test of 8 8 3 conducted to N evaluate integrity of solid SUPPLEMENTARY or REINFORCED INSULATION CREEPAGE DISTANCES and AIR CLEARANCES measured compared favourably with min distances in clause 8 9 Small chips not adversely affecting protection against electric shock or moisture disregarded a Brakes of power driven MOBILE ME EQUIPMENT normally activated and could only be released by continuous actuation of a control b MOBILE ME EQUIPMENT provided with locking means to prevent unwanted movements of ME EQUIPMENT or its parts in transport position c No unacceptable RISK due to unwanted lateral movement resulted when MOBILE ME EQUIPMENT placed in its transport position or worst case NORMAL USE position with SAFE WORKING LOAD and locking device activated on a 10 inclined hard flat surface with castors in the worst case position Following initial elastic movement creepage and pivoting of castors no further movement of MOBILE ME EQUIPMENT gt 50 mm in relation to inclined plane occurred mm Risk due to any initial movement assessed taking into consideration NORMAL USE of ME EQUIPMENT Instability excluding transport a Further movement of ME EQUIPMENT after See Appended Table 9 4 3 2 initial elastic movement was
26. d of Table 30 Nm applied RISK occurred control knob N Yes No mm Supplementary information i Gripping diameter d is the maximum width of a control knob regardless of its shape e g control knob with pointer 15 4 7 3b RM RESULTS TABLE Entry of liquids N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary information TABLE transformer short circuit test short circuit applied at end of windings or at the first point that could be short circuited under SINGLE FAULT CONDITION Primary voltage most adverse value from 90 to 110 of RATED voltage V 264 Vac RATED input frequency HZ scceseseessesseesseeseesseeeseesseesseesseesseesseesseeenseesseessnenens 50 Hz Class of Type of Protective Time to THERMAL Maximum Maximum Windi insulation protective device device STABILITY when allowed winding Ambient E t H A B E F fuse circuit operated protective device temp from temp ak E916 or H breaker Ratings Yes No did not Table 31 measured C operate Min C C TRF No IEC60601_1G SLE Page 208 of 279 Report No T223 0330 12 IEC 60601 1 Clause Verdict Requirement Test Result Remark 165 T1 Pin 1 Class B No 10 min 25 to Pin 3 primary windings T1 Pin 2 to Pin 4 primary windings T1 Pin 6
27. date of release issue and identification are available to designated persons sccccsssse Symbol 11 on Table D 1 ISO 7000 1641 DB 2004 01 used optionally advice to OPERATOR to consult ACCOMPANYING DOCUMENTS Safety sign 10 on Table D 2 safety sign IEC 60878 Safety 01 used advising OPERATOR that ACCOMPANYING DOCUMENTS must be consulted ACCESSORIES marked with name or trademark of MANUFACTURER or Supplier and with a MODEL or TYPE REFERENCE Markings applied to individual packaging when not practical to apply to ACCESSORIES MODEL or TYPE REFERENCE of equipment to be connected to ME EQUIPMENT to provide power is marked adjacent to the relevant connection point when this connection could result in an unacceptable RISK TRF No IEC60601_1G Report No T223 0330 12 Requirement Test Result Remark Packaging not part of the investigation Power supply unit is not special handling equipment No such material component accessory or equipment parts intended for single use Trademark GLOBTEK provided on the marking plate See copy of marking plate for details See Appended RM Results Table 7 2 2 The risk management requirements of the standard were not addressed See attached copy of Marking Plate No software incorporated EUT is medical in power supply unit Symbol not required EUT is medical in power supply unit No accessories provided See Appended RM Results Table
28. ordinary polyvinyl chloride sheathed flexible cord IEC 60227 1 1993 Annex A design 53 Only polyvinyl chloride insulated POWER SUPPLY See appended Table 8 10 CORD with appropriate temperature rating used for ME EQUIPMENT having external metal parts with a temperature gt 75 C touchable by the cord N NORMAL USE ccceccesseeeeeesseeeeeeeseneeenneseenens POWER SUPPLY CORDS of ME EQUIPMENT is not les than in Table 17 mm CU orisati 8 11 3 4 APPLIANCE COUPLERS complying with IEC 60320 See appended Table 8 10 1 are considered to comply with 8 11 3 5 and 8 11 30 aiiin datewesesetacbaastevunanteveds adnia daii sti 8 11 3 5 Cord anchorage for APPLIANCE COUPLERS not complying with IEC 60320 1 N A a Conductors of POWER SUPPLY CORD provided Approved appliance inlet N A with strain relieve and insulation protected provided relevant for desk from abrasion at point of entry to ME EQUIPMENT top power supply unit or a MAINS CONNECTOR by a cord anchorage b Cord anchorage of POWER SUPPLY CORD S made of and arranged as follows when a total insulation failure of POWER SUPPLY CORD caused conductive non PROTECTIVELY EARTHED 8 11 3 3 NOMINAL cross sectional area of conductors of ACCESSIBLE PARTS to exceed limits of 8 4 insulating material or metal insulated from conductive ACCESSIBLE PARTS noOn PROTECTIVELY EARTHED by a MEANS OF PROTECTION or TRF No IEC60601_1G SIS Page 68 of 279 Re
29. subjected to tests of IEC 60529 IP Code No protection against ingress of water provided Ordinary equipment ME EQUIPMENT met dielectric strength and See appended Tables 8 7 LEAKAGE CURRENT tests and there were no 8 8 3 bridging of insulation or electrical components that could result in a HAZARDOUS SITUATION in NORMAL CONDITION or in a SINGLE FAULT CONDITION ME EQUIPMENT ME SYSTEM and their parts and See Appended RM Results ACCESSORIES Cleaned or disinfected once using Table 11 6 6 and Table 11 6 methods specified in instructions for use including any cooling or drying period Cleaning or desinfection process not specified by the manufacturer End product consideration ME EQUIPMENT met dielectric strength and See appended Tables 8 7 LEAKAGE CURRENT tests with no deterioration 8 8 3 resulting in an unacceptable RISK present Effects of multiple cleanings disinfections See RM Results Table 11 6 6 during EXPECTED SERVICE LIFE of EQUIPMENT evaluated by MANUFACTURER and assurance that no unacceptable Risk will occur verified by RISK MANAGEMENT FILE r ViGW ccccsecesseceeseeeeeeeeeeeees TRF No IEC60601_1G SI gt Page 94 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 6 7 Sterilization of ME EQUIPMENT and ME SYSTEMS ia ME EQUIPMENT ME SYSTEMS and their parts or See Appended RM Results ACCESSORIES intended to be sterilized assessed Table 1
30. to values in Table 21 rows 3 and 4 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS X Radiation X radiation dose rate was lt 36 pA kg 5 uSv h See Table 10 1 1 0 5 mR h 5 cm from surface of ME EQUIPMENT including background radiation for ME EQUIPMENT not producing therapeutic diagnostic X radiation but producing ionizing radiation Amount of radiation measured by means of an ionizing chamber radiation monitor with an effective area of 10 cm or by other instruments producing equal results EUT not produces X radiation ME EQUIPMENT operated as in NORMAL USE at most unfavourable RATED MAINS VOLTAGE and controls adjusted to emit maximum radiation TRF No IEC60601_1G SIS Page 86 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Internal pre set controls not intended for adjustment during EXPECTED SERVICE LIFE of ME EQUIPMENT not taken into consideration Risk from unintended X radiation from ME See Appended RM Results EQUIPMENT producing X radiation for diagnostic Table 10 1 2 and therapeutic purposes addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE See IEC 60601 1 3 amp 1 3 Risk associated with alpha beta gamma See Appended RM Results neutron and other particle radiation when Table 10 2 applicable addressed in RISK MANAGEMENT PROCESS as shown in RISK MANAGEMENT FILE BUT not producesalpha beta gamma neutron and other radiati
31. 264 60 141 3 Measured on desk top interruption reverse polarity after version with protective earth humidity treatment Model GTM21096 series Normal condition normal polarity 264 60 87 0 Measured on open frame before humidity treatment version with protective earth Normal condition reverse polarity 264 60 86 7 Measured on open frame before humidity treatment version with protective earth Single fault condition supply 264 60 127 5 Measured on open frame interruption normal polarity before version with protective earth humidity treatment Single fault condition supply 264 60 127 1 Measured on open frame interruption reverse polarity before version with protective earth humidity treatment Maximum allowed values Fig 14 Touch Current TC 100 uA NC 500 uA SFC Model GTM 21089 series Normal condition normal polarity 264 60 88 4 Measured on output before humidity treatment Normal condition reverse polarity 264 60 88 4 Measured on output before humidity treatment Single fault condition supply 264 60 129 4 Measured on output interruption normal polarity before humidity treatment Single fault condition supply 264 60 129 4 Measured on output interruption reverse polarity before humidity treatment Model GTM 21096 series Normal condition normal polarity 264 60 78 0 Measured on output before humidity treatment Normal condition reverse polarity 264 60 78 3 Measured on output before humidity treatm
32. 6 mm JDYX2 UL E133774 Optocoupler Lite On LTV 817 Clearance creepage IEC EN VDE 94722 distance 7 0 mm 60747 U1 min FPQU2 UL E113898 5000 Vac 100 C Fairchild H11A817B Clearance creepage IEC EN VDE 104801 distance 7 0 mm 60747 ee FPQU2 UL E90700 5000 Vac 100 C Fairchild FOD817C Clearance creepage IEC EN VDE 40026857 distance 7 0 mm 60747 ae FPQU2 UL E90700 5000 Vac 100 C Everlight EL817 Clearance creepage IEC EN VDE 132249 Electronics Co distance 7 6 mm 60747 Ed min FPQU2 UL E214129 5000 Vac 100 C Cosmo K1010 Clearance creepage IEC EN VDE 101347 Electronics distance 6 5 mm 60747 Corp min FPQU2 UL E169586 5300 Vac 100 C Cosmo KP1010 Clearance creepage IEC EN VDE 101347 Electronics distance 6 5 mm 60747 Carp min FPQU2 UL E169586 5300 Vac 100 C TRF No IEC60601_1G SLE Page 161 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Sharp PC817 Clearance creepage IEC EN VDE 40008087 distance 6 4 mm 60747 ke FPQU2 UL E64380 5000 Vac 100 C Bright LED BPC 817 Clearance creepage IEC EN VDE 40007240 Electronics distance 7 6 mm 60747 Corp min FPQU2 UL E64380 5000 Vac 100 C Resistor Various Various 470 KQ IEC EN Accepted bleeding Min 1 8 W 60601 1 R8 R9 Heat sink Aluminium IEC EN Accepted L shaped 60601 1 Top dimensions 36 mm by 40 mm min 0 8 mm thick Side dimensions 24 mm
33. 7 2 5 Mains operated equipment Connection to the Supply Mains P SIS Page 32 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Except for PERMANENTLY INSTALLED ME Marking plate provided on EQUIPMENT marking appearing on the outside the outer side of the plastic of part containing SUPPLY MAINS connection enclosure desk top and adjacent to connection point version or on primary heatsink open frame PCB mounted version For PERMANENTLY INSTALLED ME EQUIPMENT EUT is not permanently NOMINAL supply voltage or range marked inside installed equipment or outside of ME EQUIPMENT preferably adjacent to supply connection terminals RATED supply voltage s or RATED voltage 100 240 Vac range s with a hyphen between minimum and maximum voltages V V V sessseeeeeerees Markings provided Nature of supply e g No of phases except Symbol provided near single phase and type of Current cessee rated supply voltage Symbols 1 5 Table D 1 symbols of IEC 60417 Symbol No 1 from table D 1 5032 5032 1 5032 2 5031 and 5033 all DB used for input voltage 2002 10 used optionally for same parameters Symbol No 4 from table D 1 used for output voltage RATED supply frequency or RATED frequency range in hertz 0 eceeeeceeeeeeeeeeeeseeeeseenseeseesseesseeneeeneees Symbol 9 of Table D 1 symbol IEC 60417 Provided on the marking 5172
34. 7 but not less than the following 1500 V r m s or 2100 V peak for Basic and See manufacturer s routine N A SUPPLEMENTARY INSULATION V testing verification 3000 V r m s or 4200 V peak for REINFORCED See manufacturer s routine N A INSULATION V testing verification Sampling tests conducted using twisted pair See manufacturer s routine N A samples IEC 60851 5 1996 clause 4 4 1 testing verification Minimum breakdown test voltage at least twice N A the voltage in Tables 6 and 7 but not less than 3000 V r m s or 4200 V peak for Basic and See manufacturer s routine N A SUPPLEMENTARY INSULATION testing verification 6000 V r m s or 8400 V peak for REINFORCED See manufacturer s routine N A INSULATION testing verification TRF No IEC60601_1G SI gt Page 128 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 4 2 RM RESULTS TABLE Risk Management Process for ME Equipment or ME N E Systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 3 3a 3 5e 4 1 4 2 4 3 4 4 5 6 1 6 2 6 3 6 4 6 5 6 6 6 7 7 Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product All clauses required checking of RMF shall be evaluated during end medical product approval 4 3 TABLE
35. 8 and appended RM failure of alarm system addressed in RISK Results Table 12 3 MANAGEMENT PROCESS No alarm incorporated from intentional exceeding of safety limits Table 12 4 1 addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 0 sss00ss000 SELV rellability tests performed See enclosed table for details TRF No IEC60601_1G SI Page 95 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark When applicable need for indication of See Appended RM Results parameters associated with hazardous output Table 12 4 2 addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 2 001 RISKS associated with accidental selection of See Appended RM Results excessive output values for ME EQUIPMENT with Table 12 4 3 a multi purpose unit designed to provide low and high intensity outputs for different treatments addressed in RISK MANAGEMENT PROCESS confirmed in RISK MANAGEMENT FILE Single output voltage When applicable RISKS associated with See Appended RM Results incorrect output addressed in RISK MANAGEMENT Table 12 4 4 PROCESS as confirmed by review of RISK MANAGEMENT FILE s ccceesseceeeesseeeenesseeeenssseeeens 12 4 5 Diagnostic or therapeutic radiation 12 4 5 1 Adequate provisions to protect OPERATORS PATIENTS other persons and sensitive devices in vicinity of unwanted or excessive radiation emitted by ME
36. 94V 0 at min 0 45 mm thickness T375J or 94V 1 at min 1 0 mm thickness T373J QMFZ2 UR E59481 RTI 150 C Temperature class B Input Molex A 41791 series UL94 V0 IEC EN Accepted connector Electronics 7 A I 250 Vac per 60601 1 Model contact ECBT2 UL E29179 GTM21096 P Class construction 3 pins Class Il construction 2 pins Output Molex A 42227 series UL94 V0 IEC EN Accepted connector Electronics 4 A I 250 Vac per 60601 1 Model contact ECBT2 UL E29179 GTM21096 Joint Tech A2542 series UL94 V0 IEC EN Accepted Electronic 4 A I 250 Vac per 60601 1 contact ECBT2 UL E179987 TRF No IEC60601_1G SI gt Page 164 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information 1 An asterisk indicates a mark which assures the agreed level of surveillance See Licenses and Certificates of Conformity for verification means that components from other vendor and other model number but with the same or better higher rating and equivalent approvals are accepted 8 10 1 RM RESULTS TABLE Fixing of components N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information All internal components mounted securely Some internal components additionally fixed with glue See enclosed pictu
37. A GTM21096 1512 2 0 F FW R RW 10 0 Vdc 1 5 A GTM21096 1512 1 0 F FW R RW 11 0 Vdc 1 3 A GTM21096 1512 X X F FW R RW 12 0 Vdc 1 25 A GTM21096 1815 2 0 F FW R RW 13 0 Vdc 1 15 A GTM21096 1815 1 2 F FW R RW 13 8 Vdc 1 09 A GTM21096 1815 1 0 F FW R RW 14 0 Vdc 1 07 A GTM21096 1815 X X F FW R RW 15 0 Vdc 1 2 A GTM21096 1818 2 0 F FW R RW 16 0 Vdc 1 2 A GTM21096 1818 1 0 F FW R RW 17 0 Vdc 1 0 A GTM21096 1818 X X F FW R RW 18 0 Vdc 1 0 A GTM21096 1824 5 0 F FW R RW 19 0 Vdc 0 95 A GTM21096 1824 4 0 F FW R RW 20 0 Vdc 0 90 A GTM21096 1824 X X F FW R RW 24 0 Vdc 0 75 A GTM21089 1948 20 4 F FW R RW 27 6 Vdc 0 65 A GTM21089 1948 18 0 F FW R RW 30 0 Vdc 0 60 A GTM21089 1948 12 0 F FW R RW 36 0 Vdc 0 50 A GTM21089 1948 X X F FW R RW 48 0 Vdc 0 39 A TRF No IEC60601_1G Testing procedure and testing location CB Testing Laboratory Testing location address Associated CB Test Laboratory Testing location address s0 Tested by name signature Approved by signature Testing procedure TMP Tested by name signature Approved by signature Testing l
38. DB 2003 02 used for CLASS II ME plate of power supply unit EQUIPMENT vasra eraen au aieiaa RATED input in amps or volt amps or in watts Rated input expressed in when power factor exceeds 0 9 A VA W Amperes 0 50 0 25A Specified for lower and upper voltage range See copy of marking plate for details RATED input for one or more RATED voltage 0 50 0 25 A ranges provided for upper and lower limits of the range or ranges when the range s is are greater than 10 of the mean value of specified range A VA W ssseesseserseeseeseerees See copy of marking plate for details Specified for lower and upper voltage range Input at mean value of range marked when range limits do not differ by more than 10 from mean value A VA W eseceeseeeeeeeeees Marking includes long time and most relevant momentary volt ampere ratings when provided each plainly identified and indicated in ACCOMPANYING DOCUMENTS VA ssceeeseeeeeeeeeees TRF No IEC60601_1G SI Page 33 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Marked input of ME EQUIPMENT provided with N A means for connection of supply conductors of other electrical equipment includes RATED and marked output of such means A VA W 7 2 8 1 See 16 9 2 1 b for MULTIPLE SOCKET OUTLETS N A integral with ME EQUIPMENT 7 2 8 2 Output connectors are marked except for Rating of the output MULTIPLE
39. Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 See also RM Table for 4 6 Supplementary Information No applied parts provided 8 4 2 TABLE TABLE Working Voltage Power Measurement P Test supply voltage frequency V Hz ase esteeneeesieenagesteenteesieenteesteenteesieesteaeeseneneeess 240 Vac 50 Hz Location Measured values nromute Vime Vpk or Peak to Power Energy Remarks Vdc peak ripple WI VA J Model GTM21089 1305 Measured 5 21 Vdc 31 0 VA Maximum output between current achieved output minus and AA output plus Output voltage 1 00 Vdc TRF No IEC60601_1G SLE Page 141 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark 8 4 2 TABLE TABLE Working Voltage Power Measurement P Measured 5 21 Vdc 29 6 VA Maximum output between current achieved R12 output shorted minus and output plus IPLA Output voltage 5 17 Vdc Model GTM21089 1512 Measured 12 01 Vdc 31 6 VA Maximum output between current achieved output minus and 263 4 output plus Output voltage 2 66 Vdc Measured 12 01 Vdc 34 4 VA Maximum output between current achieved R12 output shorted minus and 2 86 A output plus Output voltage 11 70 Vdc Model GTM21089 1824 Measured 23 54 Vdc 42 4 VA Maximum outpu
40. EARTH CONNECTION Class II ME EQUIPMENT Third conductor of POWER SUPPLY CORD connected to protective earth contact of MAINS PLUG provided with CLASS II ME EQUIPMENT with isolated internal screens used as functional earth connection to the screen s FUNCTIONAL EARTH TERMINAL coloured green and yellow Two MEANS OF PROTECTION provided by insulation of internal screens and all internal wiring connected to them with a related explanation in technical description a Electrical isolation providing protection See appended Tables 8 7 against electric shock limits currents to values WV BFS sce P E T T cedvendvesaieies b Specified values of EARTH LEAKAGE TOUCH See appended Tables 8 7 PATIENT LEAKAGE and PATIENT AUXILIARY CURRENTS applied in combination of conditions in appended Table 8 7 secsseseeeceeeeeeeeseenees J po where insulation used in conjunction with a PROTECTIVE EARTH CONNECTION insulation short circuited only under conditions in 8 6 4 b the only SINGLE FAULT CONDITION for EARTH Considered LEAKAGE CURRENT was interruption of one supply conductor at a time LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENT not measured in SINGLE FAULT CONDITION of short circuiting of one constituent part of DOUBLE INSULATION SINGLE FAULT CONDITIONS not applied at same No applied parts provided time as special test conditions of MAXIMUM MAINS VOLTAGE On APPLIED PARTS and non PROTEC
41. EQUIPMENT designed to produce radiation for diagnostic therapeutic purposes mM safety ensured by compliance with mS of appropriate standards 12 4 5 2 RISKS associated with diagnostic X rays See IEC 60601 1 3 Report addressed in RISK MANAGEMENT PROCESS as and appended RM Results confirmed in RISK MANAGEMENT FILE 0 0 Table 12 4 5 2 12 4 5 3 RISKS associated with radiotherapy addressed See Appended RM Results in RISK MANAGEMENT PROCESS as confirmed by Table 12 4 5 3 review of RISK MANAGEMENT FILE ccccesseeees n 12 4 5 4 RISKS associated with ME EQUIPMENT producing See Appended RM Results diagnostic or therapeutic radiation other than Table 12 4 5 4 diagnostic X rays and radiotherapy addressed in RISK MANAGEMENT PROCESS as confirmed py examination of RISK MANAGEMENT FILE s 12 4 6 When applicable RISKS associated with See Appended RM Results diagnostic or therapeutic acoustic pressure Table 12 4 6 addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 0 HAZARDOUS SITUATIONS AND FAULT CONDITIONS None of HAZARDOUS SITUATIONS in 13 1 2 13 1 4 No hazardous situations inclusive occurred when SINGLE FAULT occur during single fault CONDITIONS applied one at a time as in 4 7 and _ testing 13 2 13 1 2 Emissions deformation of ENCLOSURE or exceeding maximum temperature TRF No IEC60601_1G SI gt Page 96 of 279 Report No T223 0330 12 IEC 60601 1
42. ESSENTIAL PERFORMANCE N E MANUFACTURER S document number reference or reference from this standard Remarks or collateral or particular standard s List of ESSENTIAL PERFORMANCE functions Reinforced insulation Tested in accordance with between primary and IEC60601 1 2005 to secondary 2 x MOOP comply with 2 x MOOP requirements Basic insulation between Tested in accordance with primary and protective earth IEC60601 1 2005 to 1x MOOP comply with 1 x MOOP requirements TRF No IEC60601_1G SI Page 129 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 4 3 TABLE ESSENTIAL PERFORMANCE N E MANUFACTURER S document number reference or reference from this standard Remarks or collateral or particular standard s List of ESSENTIAL PERFORMANCE functions Supplementary Information The risk management requirements of the standard were not addressed EUT is not end medical product All clauses required checking of RMF shall be evaluated during end medical product approval Essential performance is performance the absence or degradation of which would result in an unacceptable risk For the EUT essential performance is considered 2 x Means Of Operator Protection 2 x MOOP which provided reinforced isolation to the operator within the equipment and 1 x Means Of Operator Protection 1 x MOOP which provided basic isolation to opera
43. English version evaluated acceptable to the intended operator Instructions for use include all warning and Provided within user safety notices instructions Warning statement for CLASS ME EQUIPMENT Relevant for models with indicating WARNING To avoid risk of electric protective earth shock this equipment must only be connected to a supply mains with protective earth Warnings regarding significant RISKS of N A reciprocal interference posed by ME EQUIPMENT during specific investigations or treatments Information on potential electromagnetic or Not specified other interference and advice on how to avoid arse EUT is medical in power or minimize such interference UT is dic p supply unit Shall be evaluated during end medical product Warning statement for ME EQUIPMENT supplied with an integral MULTIPLE SOCKET OUTLET indicating connecting electrical equipment to MSO effectively leads to creating an ME SYSTEM and can result in a reduced level of safety separate power supply indicating power supply is specified as a part of ME EQUIPMENT or combination is specified as a ME SYSTEM TRF No IEC60601_1G SI Page 41 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Warning statement for mains operated ME No additional power source EQUIPMENT with additional power source not provided automatically maintained in a fully usable condition indicating the necessity for per
44. FILE ccceceenececucneeeceeeeeveeseeesueneeeseeen Glue used for fixing of some components to prevent movement reduction of creepage and clearance distances All other components mounted securely Unwanted movement of single component not result unacceptable risk See enclosed pictures of the unit for details Conductors and connectors of ME EQUIPMENT See Appended RM Results adequately secured or insulated to prevent Table 8 10 2 accidental detachment in a HAZARDOUS SITUATION Output cable is provided with cord anchorage to prevent displacement of the secondary wires in case of accidental displacement Through the hole method used in additionally to soldering for fixing internal protective earth conductor Conductors and connectors of ME EQUIPMENT Conductor of output cable when breaking free at their joint are not capable of touching circuit points resulting in a HAZARDOUS SITUATION as indicated in RISK MANAGEMENT FILE Breaking free of one means of mechanical Considered restraint considered a SINGLE FAULT CONDITION Stranded conductors are not solder coated when secured by clamping means to prevent HAZARDOUS SITUATIONS due to poor contact Flexible cords detachable without a TOOL used See Appended Table 5 9 2 a to interconnect different parts of ME EQUIPMENT provided with means for connection to comply with requirements for metal ACCESSIBLE PARTS of 8 4 when a connection is loosened or broken as
45. Inc 1350T 1 Min 0 06 mm thick IEC EN Accepted 44 Min 130 C aeons 1350F 1350 1 OANZ2 UL E50292 Yahua 35660Y Min 0 06 mm thick IEC EN Accepted Min 130 C Soosi OANZ2 UL E165111 Primary Various Various Min 22 AWG IEC EN Accepted betwee Min 80 C seen Class Il Min 300 V OVINA approved appliance inlet and PCB Protective Various Various Min 18 AWG IEC EN Accepted E Pain gone nae Greenlyellow AVLV2 UL approved insulation TRF No IEC60601_1G SLE Page 163 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Transformer Comp open type construction IEC EN Accepted T1 Alternative BOAM or GlobTek or ZhongTong 60601 1 Primary enamelled copper wire Secondary triple insulated wire Furukawa TEX E or Great Leoflon TRWB or equivalent Bobbin Phenolic QMFZ2 UR E59481 type T373J T375J from Chang Chun rated min 94V 1 at min thickness 0 45 mm RTI 150 C or QMFZ2 UR E41429 type PM 9820 from Sumitomo Bakelite rated 94V 0 at min 0 16 mm thickness measured thickness 0 5 mm RTI 150 C or equivalent Insulation UL insulation system Electronics Corp ST 2804 Class B or BOAM BOAM 01 Class B or GlobTek GTX 130 TM Class B or ZhongTong ZT 130 Class B Inductor IEC EN Accepted LF1 04A054 60601 1 Alternative Sunycore or BOAM or Globtek or ZhongTong Open type construction Bobbin T373J or T375J by Chang Chun rated
46. No amp paragraph 4 2 TRF No IEC60601_1G SLE Page 194 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark 12 4 6 RM RESULTS TABLE Diagnostic or therapeutic acoustic pressure N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 13 1 2 TABLE measurement of power or energy dissipation in parts amp components to N A waive SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 and 13 2 2 relative to emission of flames molten metal or ignitable substances Power dissipated less than W sssssesseeesens gt 115 Energy dissipated less than J sssesessessseesees 1900 Part or component Measured Calculated energy SINGLE FAULT CONDITIONS Remarks tested power dissipated J waived Yes No dissipated W Supplementary information 13 2 TABLE SINGLE FAULT CONDITIONS in accordance with 13 2 2 to 13 2 13 inclusive P Clause Results observed HAZARDOUS Ne Description of SINGLE FAULT CONDITION acon p Yes No 13 2 2 Electrical SINGLE FAULT CONDITIONS per Clause 8 1 1 Short circuit of T1 Pin 1 to Pin 3 No output voltage No Supply voltage 264 Vac Primary fuse opened Model GTM21089 1824 24 Vdc output immediately No high temperature rises observe
47. No parts that can come with Clause 722210 vicar EE E E E E A the patient EUT is medical power supply unit TRF No IEC60601_1G SIS Page 24 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 4 7 ME EQUIPMENT remained SINGLE FAULT SAFE or See Appended RM Results N E the RISK remained acceptable as determined by Table 4 7 Cla Se 42 aantre aenneren eaaa The risk management requirements of the standard were not addressed All applicable single fault conditions performed according to the standard Failure of any one component at a time that See Appended Table 13 2 for P could result in a HAZARDOUS SITUATION including simulated physical test or those in 13 1 simulated physically or See Attachment No ___ for theoretical yi sccctccstccscsessecscerseceseeendeecetacesseeeaqersee theoretical simulation Physically testing performed RISK associated with failure of component Short circuit or open circuit P during EXPECTED SERVICE LIFE of ME EQUIPMENT of relevant single taken into account to evaluate if a component components performed should be subjected to failure simulation See Table 13 2 Single fault conditions in accordance with 13 2 2 to 13 2 13 inclusive 4 8 All components and wiring whose failure could See Appended RM Results P result in a HAZARDOUS SITUATION used according Table 4 8 N E to their applicable ratings except as specimed The
48. No pressure relief devices provided A pressure relief device shall also comply as applicable to the requirements of ASME PTC 25 or equivalent Canadian requirements SIS Page 221 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Construction of connectors No gas cylinders provided The point of connection of gas cylinders to EQUIPMENT shall be gas specific and clearly identified so that errors are avoided when a replacement is made Medical gas inlet connectors on EQUIPMENT shall be i gas specific yoke type or nut and nipple type valve connections complying with CGA V 1 for pressures over 1 380 kPa 200 psi or DISS type complying with CGA V 5 for pressures 1 380 kPa 200 psi or less and configured to permit the supply of medical gases from low pressure connecting assemblies complying with CAN CSA Z5359 NOTE 1A Users of this standard should consult the CSA Z305 series of standards CAN CSA Z9170 1 CAN CSA Z9170 2 CAN CSA Z10524 and CAN CSA Z15002 for further information regarding inlet connectors ISO 407 for requirements addressing yoke type valve connections and ISO 32 for colour coding Internal wiring of ME EQUIPMENT Internal wiring of ME EQUIPMENT shall be in accordance with the Canadian Electrical Code CEC Part 1 CSA C22 1 MULTIPLE SOCKET OUTLET No multiple socket outlets The MULTIPLE SOCKET OUTLET shall comply _ Provided with the requiremen
49. Plastic enclosure is classified UL94 V 1 minimum Not relevant for open frame and PCB mounted version ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT ME SYSTEMS and parts described in ACCOMPANYING DOCUMENTS for use with flammable anaesthetics CATEGORY AP or anaesthetics with oxidants CATEGORY APG comply with Annex G EUT is not intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable N A agents MANUFACTURER S RISK MANAGEMENT PROCESS addresses possibility of fire and associated mitigations as confirmed by examination of RISK MANAGEMENT FILE ssseeceeeeeeeeeeesseeeeseeeeeeneees See Appended RM Results Table 11 5 EUT is not intended for use in conjunction with flammable agents Overflow spillage leakage ingress of water or particulate matter cleaning disinfection sterilization and compatibility with substances used with the ME EQUIPMENT Sufficient degree of protection provided against overflow spillage leakage ingress of water or particulate matter cleaning disinfection and sterilization and compatibility with substances used with ME EQUIPMENT Liquid reservoir liable to overflow in NORMAL USE completely filled and 15 of its capacity poured in for over 1 min and except when restricted TRANSPORTABLE ME EQUIPMENT tilted through an angle of 15 in least favourable direction s
50. RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 5 Supplementary Information No applied parts provided 8 5 2 3 RM RESULTS TABLE PATIENT Leads N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary Information No patient leads provided TABLE defibrillation proof applied parts measurement of hazardous electrical energies Test Measurement Applied part with Test voltage Measured Remarks Condition made on test voltage polarity voltage between Figs 9 amp 10 accessible part Y1 and Y2 mV Supplementary information No applied parts provided 8 5 5 1b TABLE defibrillation proof applied parts verification of recovery time pE part with test Test voltage Recovery time from Measured voltage polarity documents s recovery time s Supplementary information No applied parts provided TABLE DEFIBRILLATION PROOF APPLIED PARTS Or PATIENT CONNECTIONS of DEFIBRILLATION PROOF APPLIED PARTS Energy reduction test measurement of Energy delivered to a 100 Q load Test Voltage applied to Measured Energy Measured Energy Energy E1 E1 mJ E2 mJ as of E2 TRF No IEC60601_1G SLE Page 145 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark PATIENT CONNECTION 1 or APPLIED PART with
51. Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 TRF No IEC60601_1G SI gt Page 203 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 15 3 3 RM RESULTS TABLE Impact test N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary information No damage of the enclosure after impact test 15 3 4 2 RM RESULTS TABLE Portable ME equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information No damage of the enclosure after drop test 15 3 5 RM RESULTS TABLE Rough handling test N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information EUT is not mobile equipment 15 4 1 RM RESULTS TABLE Construction of connectors N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 TRF No IEC60601_1G SI gt Page 204 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 15 4 1 RM RESULTS TABLE Construction of connectors N A
52. SOCKET OUTLETS or connectors intended connector provided on the for specified ACCESSORIES or equipment marking plate See copy of marking plate for details Rated Voltage V Rated Current A 005 See copy of marking plate for details Rated Power W Output Frequency H2 DC output voltage a 7 2 9 ME EQUIPMENT or its parts marked with the IP No protection against environmental Code per IEC 60529 according to ingress of water provided classification in 6 3 Table D 3 Code 2 therefore no marking required Ordinary equipment Degrees of protection against electric shock as No applied parts provided classified in 6 2 for all APPLIED PARTS marked with relevant symbols as follows not applied to parts identified according to 4 6 TYPE B APPLIED PARTS with symbol 19 of Table D 1 IEC 60417 5840 DB 2002 10 not applied in such a way as to give the impression of being inscribed within a square in order to distinguish it from symbol IEC 60417 5333 TYPE BF APPLIED PARTS with symbol 20 of Table D 1 IEC 60417 5333 DB 2002 10 TYPE CF APPLIED PARTS with symbol 21 of Table D 1 IEC 60417 5335 DB 2002 10 DEFIBRILLATION PROOF APPLIED PARTS marked with symbols 25 27 of Table D 1 IEC 60417 5841 IEC 60417 5334 or IEC 60417 5336 all DB 2002 10 Proper symbol marked adjacent to or on connector for APPLIED PART except marked on APPLIED PART when there is no connector or connector use
53. Test Pressure Supplementary Information No pressure vessels provided 9 7 6 RM RESULTS TABLE Pressure control device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 7 7 RM RESULTS TABLE Pressure relief device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 TRF No IEC60601_1G SI gt Page 174 of 279 Report No T223 0330 12 9 7 7 RM RESULTS TABLE Pressure relief device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 1 RM RESULTS TABLE Hazards associated with support systems General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 2 RM RESULTS TABLE Tensile safety factor N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 3 1 RM RESULTS TABLE Stren
54. VOLTAGE for each MEANS OF See Insulation Diagram and PROTECTION forming DOUBLE INSULATION was Insulation Table voltage DOUBLE INSULATION as a whole subjected to V cccccessseeecesseneeeeseseeeenseeeeeneeeeeees Intentional or accidental earthing of PATIENT regarded as a NORMAL CONDITION for WORKING VOLTAGE involving a PATIENT CONNECTION not connected to earth WORKING VOLTAGE between PATIENT No applied parts provided CONNECTIONS of an F TYPE APPLIED PART and ENCLOSURE was highest voltage appearing across insulation in NORMAL USE including earthing of any part of APPLIED PART V WORKING VOLTAGE for DEFIBRILLATION PROOF No applied parts provided APPLIED PARTS determined disregarding possible presence of defibrillation voltages WORKING VOLTAGE for d c voltages with superimposed ripple was average value when peak to peak ripple less than 10 of average value or peak voltage when peak to peak ripple exceeding 10 of average value V 0 f TRF No IEC60601_1G SI Page 53 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark WORKING VOLTAGE was equal to resonance No motors provided voltage in case of motors provided with capacitors between the point where a winding and a capacitor are connected together and a terminal for external conductors V Classification DEFIBRILLATION PROOF APPLIED N A PART applied to one APPLIED PART in its e
55. a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE supplied from a source isolated from earth by insulation equal to one MEANS OF PATIENT PROTECTION and from electrical parts by insulation twice the MEANS OF PATIENT PROTECTION ccccssseeeseeeeseeeeesees Test of G 6 1 waived when the following requirements were met in NORMAL USE and under NORMAL and SINGLE FAULT CONDITIONG m Operating temperature of external surface of TRF No IEC60601_1G SI gt Page 124 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark a no sparks produced and temperatures did See Tables 11 1 1 11 1 2 1 not exceed 90 C or 11 1 2 2 11 2 2 1 and 13 2 b a temperature limit of 90 C not exceeded See Tables 11 1 1 11 1 2 1 sparks produced in NORMAL USE and SINGLE 11 1 2 2 and 13 2 FAULT CONDITIONS except Umax and Imax occurring in their circuits complied with requirements taking Cmax and Lmax into consideration Measured Umax lt Uzr with Lp as in Fig G 4 Measured U max lt Uzc with Cmax as in Fig G 5 Measured Imax Izr With Uzr as in Fig G 4 Measured Imax 1 with Lmax and a Umax S 24 V AA EEA E A E A Extrapolation from Figs G 4 G 5 and G 6 was limited to areas indicated Umax was the highest no load voltage occurring in the circuit under investigation taking into consideration mains voltage variations as in 4 10 Imax Was the highest current fl
56. a c 60 V d c or less performed only when examination and review of design indicated possibility of an overload Test not conducted where electronic drive N A circuits maintained a substantially constant drive current Test not conducted based on other N A justifications justification eeeseeeeeeeeees c ME EQUIPMENT with 3 phase motors operated N A with normal load connected to a 3 phase SUPPLY MAINS with one phase disconnected and periods of operation per 13 2 10 13 2 13 4 ME EQUIPMENT RATED for NON CONTINUOUS OPERATION EE ME EQUIPMENT other than HAND HELD operated EUT is designed for under normal load and at RATED voltage or at continuous operation upper limit of RATED voltage range until increase in temperature was lt 5 C in one hour or a protective device operated When a load reducing device operated in NORMAL USE test continued with ME EQUIPMENT running idle Motor winding temperatures did not exceed values in 13 2 10 ceeccccesseeceseeeeeeeeeeeeseseeeeeneeeneees Insulation Class uw ccccccsesssseseceesseseenesseeeesseeeenes Maximum temperature measured C TRF No IEC60601_1G SLE Co 14 1 Page 100 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS PEMS E Requirements of this clause not applied to EUT is not programmable PESS when it provided no BASIC SAFETY or electrical medical system
57. and CLEARANCES required for one MEANS OF OPERATOR PROTECTION appropriate for highest voltage occurring across SEPARATION DEVICE during a fault condition WORKING VOLTAGE was highest voltage across SEPARATION DEVICE during a fault condition but not less than MAXIMUM MAINS VOLTAGE V 16 6 1 TOUCH CURRENT in NORMAL CONDITION from or See appended Table 16 6 1 between parts of ME SYSTEM within the PATIENT ENVIRONMENT did not exceed 100 WA TOUCH CURRENT did not exceed 500 pA in event See appended Table 16 6 1 of interruption of any non PERMANENTLY INSTALLED PROTECTIVE EARTH CONDUCTOR from or between parts of ME SYSTEM within PATIENT ENVIRONMENT cccccessecceeesseeeeeeseeeeeeesseneeenssseeeneas 16 6 2 Current in PROTECTIVE EARTH CONDUCTOR of N A MULTIPLE SOCKET OUTLET did not exceed 5 mA 16 6 3 PATIENT LEAKAGE CURRENT and total PATIENT See appended Tables 8 7 LEAKAGE CURRENT of ME SYSTEM in NORMAL 8 7 4 7 and 16 6 1 CONDITION did not exceed values specified for ME EQUIPMENT in Tables 3 and 4 cseeeeeeee Measurements made using a device as in N A clause 8 7 4 4 16 7 ME SYSTEM complied with applicable See applicable appended requirements of Clause 9 when a MECHANICAL Tables in section 9 HAZARD CXiStOC 2 ceceeeseeeceeeeeeeeeeeeneeeeeeeeeeeenenees Interruption and restoration of relevant power connections of ME SYSTEM one at a time and all connections simultaneously did no
58. centre of the plane of the marking and at a distance of 1 m Marking plate provided on the outer side of the plastic enclosure Power supply unit is not end medical product Not relevant for open frame and PCB mounted version marking plate shall not be visible after final installation within the end medical product TABLE Durability of marking test P Characteristics of the Marking Label tested Remarks Material of Marking Label ccsssesesseeee Polyester label Pass Ink other printing material or process Ink printing Pass Material composition of Warning Label No warning labels provided on the N A outer side of the enclosure Ink other printing material or process N A OAT E T S N A Supplementary information Marking rubbed by hand first for 15 s with a cloth rag soaked with distilled water then for 15 s with a cloth rag soaked with methylated spirit and then for 15 s with a cloth rag soaked with isopropyl alcohol Marking plate provided on the outer side of the plastic enclosure desk top version or on the heatsink open frame version PCB mounted version 7 2 2 RM RESULTS TABLE Identification N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 4 Supplementary Information The risk management requirements of the standa
59. equipment outside control of PEMS MANUFACTURER by NETWORK DATA COUPLING a characteristics of NETWORK DATA COUPLING necessary for PEMS to achieve its INTENDED USE b list of HAZARDOUS SITUATIONS resulting from a failure of NETWORK DATA COUPLING to provide the specified characteristics 14 13 Technical description includes the following See Appended RM Results information when PEMS is to be connected to Table 14 13 c instructions to RESPONSIBLE ORGANIZATION containing required information and warnings connection of PEMS to a NETWORK DATA COUPLING that includes other equipment could result in previously unidentified RISKS and RESPONSIBLE ORGANIZATION Shall identify analyze and control such RISKS subsequent changes to NETWORK DATA COUPLING introducing new RISKS and requiring new analysis and changes to NETWORK DATA COUPLING include TRF No IEC60601_1G SI gt Page 104 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark LE NETWORK DATA COUPLING configuration change Se ee E connection of additional items to NETWORK DATA COUPLING disconnecting items from NETWORK DATA COUPLING update of equipment connected to N A NETWORK DATA COUPLING upgrade of equipment connected to N A NETWORK DATA COUPLING CONSTRUCTION OF ME EQUIPMENT oP R sKs associated with arrangement of controls See Appended RM Results and indicators of ME EQUIPMENT addressed in Table 15 1
60. for use in conjunction with flammable agents TRF No IEC60601_1G SI gt Page 12 of 279 Report No T223 0330 12 Summary of testing The component was tested according to the standard IEC 60601 1 2005 3rd Edition and or EN 60601 1 2006 A11 2011 The risk management requirements of the standard were not addressed The power supply tested in this test report is only component level power supply Risk management shall be addressed to the end type medical equipment Essential performance shall be determined within the end medical equipment however for this medical power supply essential performance is considered MOOP MOOP is tested within this test report Power supply unit can be Desk top equipment Model GTM21089 Appliance inlet used for connection to the mains Open frame equipment Model GTM21096 PCB mounted Model GTM21096 Power supply unit was evaluated only for Means of Operator Protection 2 x MOOP between primary and secondary circuit 2 x MOOP between primary and external plastic enclosure surface for models with external enclosure 1x MOOP between primary and protective earth for models with protective earth Secondary output circuit is separated from mains by reinforced insulation and rated SELV The output does not provide hazard energy level Power supply unit provides internally two primary fuses in line and in neutral Safety Class of the power supply unit Desk top version Class or Cla
61. hot or cold accessible surfaces removable only with a TOOL 11 2 1 ENCLOSURE has strength and rigidity necessary See clause 15 3 to prevent a fire caused by reasonably Releva ntonivformodels foreseeable misuse and met mechanical y strength tests for ENCLOSURES in 15 3 with external enclosure 11 2 2 Me equipment and me systems used in conjunction with OXYGEN RICH N A ENVIRONMENTS RISK of fire in an OXYGEN RICH ENVIRONMENT See appended Table 8 10 reduced by means limiting spread of fire under NORMAL Or SINGLE FAULT CONDITIONS when source sip a EA eta ata of ignition in contact with ignitable material jur yg rich environment Requirements of 13 1 1 applied to oxygen concentrations up to 25 at one atmosphere or partial pressures up to 27 5 kPa for higher atmospheric pressures a No sources of ignition discovered in an OXYGEN RICH ENVIRONMENT in NORMAL and SINGLE FAULT CONDITIONS under any of the following conditons sisari eae EE ae daie ORSAKER 1 when temperature of material raised to its ignition temperature TRF No IEC60601_1G SLE Clause Page 89 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict 2 when temperatures affected solder or solder joints causing loosening short circuiting or other failures causing sparking or increasing material temperature to its ignition temperature 3 when parts affecting safety cracked or changed outer shape exposing te
62. less than 50 mm when MOBILE ME EQUIPMENT with a SAFE WORKING LOAD positioned on a 5 inclined hard flat surface with wheel locked or braking system activated mm Risk due to initial movements assessed taking into consideration NORMAL USE of ME EQUIPMENT b TRANSPORTABLE or STATIONARY ME EQUIPMENT for use on the floor and with a SAFE WORKING LOAD prepared as in 9 4 2 2 and placed ona horizontal plane with locking device activated and castors when supplied in their worst case position TRF No IEC60601_1G SLE Page 78 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict Further movement of ME EQUIPMENT after initial See Appended Table 9 4 3 2 elastic movement was no more than 50 mm when a force of 25 of weight of unit but less than 220 N applied in different directions except a direction with an upwards component at highest point of ME EQUIPMENT but lt 1 5 m from floor Risk due to initial movements assessed taking N A into consideration NORMAL USE of ME EQUIPMENT Grips and other handling devices NA a ME EQUIPMENT other than PORTABLE No grips and other handling EQUIPMENT or its part with a mass of over 20 kg devices provided requiring lifting in NORMAL USE or transport provided with suitable handling means or ACCOMPANYING DOCUMENTS specify safe lifting method except when handling is obvious and causing HAZARDS Handles when supplied suitabl
63. made For supply connections use wiring materials suitable for at least X C where X gt than max temperature measured in terminal box or wiring compartment under NORMAL USE or equivalent marked at the point of supply connections Statement not applied to parts requiring removal to make the connection and CLEARLY LEGIBLE after connections made Marking of controls and instruments N A The on amp off positions of switch to control No mains switch provided power to ME EQUIPMENT or its parts including mains switch marked with symbols 12 and 13 of Table D 1 IEC 60417 5007 DB 2002 10 and IEC 60417 5008 DB 2002 10 or The on off positions of push button switch with bi stable positions marked with symbol 14 of Table D 1 IEC 60417 5010 DB 2002 10 and The on off positions of push button switch with momentary on position marked with symbol 15 of Table D 1 symbol 60417 5011 DB 2002 10 or Controls provided with an associated See Appended RM Results indicating device when change of setting ofa Table 7 4 2 control could result in an unacceptable RISK to PATIENT in NORMAL USE or an indication of direction in which magnitude of the function changes Numeric indications of parameters on ME EQUIPMENT expressed in SI units according to ISO 31 except the base quantities listed in Table 1 expressed in the indicated units TRF No IEC60601_1G SI gt Page 38 of 279 Report No T
64. of conductors and covers fitted without damage to conductors or their insulation Correct connection and positioning of conductors before ACCESS COVER was fitted verified by an installation test Mains fuses and OVER CURRENT RELEASES A fuse or OVER CURRENT RELEASE provided in See appended Table 8 10 each supply lead for CLASS and CLASS II ME and Appended RM Results EQUIPMENT with a functional earth connection Table 8 11 5 per clause 8 6 9 and in at least one supply lead for other single phase CLASS II ME EQUIPMENT Primary fuses Incorporated in both supply leads F1 F2 neutral conductor not fused for PERMANENTLY Not permanently installed INSTALLED ME EQUIPMENT equipment Effect of short circuit fault conditions in other circuits taken into consideration before eliminating fuses or OVER CURRENT RELEASES Protective devices have adequate breaking See appended Table 8 10 capacity to interrupt the maximum fault current including the available short circuit A fuse or OVER CURRENT RELEASE not provided Not fused in a PROTECTIVE EARTH CONDUCTOR Fuses complying with IEC 60127 have high Primary fuse operated breaking capacity 1 500 A and prospective during single fault condition short circuit current gt 35 A or 10 times current without safety hazard rating of the fuse whichever is greater occurs Justification for omission of fuses or OVER CURRENT RELEASES is in RISK MANAGEMENT FILE Internal wiring of the MA
65. on the transformer windings by thermocouple 11 1 3 RM RESULTS TABLE Measurements N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information Temperature measurements performed Test corner used Temperature of test corner not exceeds 90 C in normal conditions 11 2 2 1 RM RESULTS TABLE Risk of fire in an oxygen rich environment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 TRF No IEC60601_1G SI gt Page 186 of 279 Report No T223 0330 12 11 2 2 1 RM RESULTS TABLE Risk of fire in an oxygen rich environment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 Supplementary information Not evaluated 11 2 2 1 TABLE Alternative method to 11 2 2 1 a 5 to determine existence of an N A ignition source Areas where sparking might cause ignition Remarks 1 2 3 5 6 Materials of the parts between which sparks could occur Composition Grade Remarks Designation Manufacturer 1 HP a P S N Test parameters selected representing worst case conditions for ME EQUIPMENT Remarks
66. rated load T1 Pin 6 to Pin 8 T1 Pin 8 to after D8 Fault test performed on voltage limiting Voltage measured V in SELV circuits components V peak or V d c Short circuit of diode D8 Unit switched off immediately Output voltage dropped to 0 V immediately No defect No hazard T1 Pin 6 to Pin 8 T1 Pin 8 to after D8 Fault test performed on voltage limiting Voltage measured V in SELV circuits components V peak or V d c Short circuit of diode D8 Unit switched off immediately Output voltage dropped to 0 V immediately No defect No hazard Supplementary information Model GTM21089 1824 TRF No IEC60601_1G SIS Page 212 of 279 Report No T223 0330 12 Encl No 1 Enclosure No 1 National Differences to IEC 60601 1 2005 13 pages including this cover page SIS Page 213 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark US NATIONAL DIFFERENCES to IEC 60601 1 Third edition National standard ANSI AAMI ES60601 1 2005 When no relevant US ANSI standard existed Considered the requirements of this standard applied 4 10 2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Replacement Reference to 500 V replaced Considered with 600 V in the second and third dashes to agree with the National Electrical Code NEC and the NEC added after the reference to IEC 60364 4 41 in the text of the second to last dash of this sub clause to agre
67. regulations Waste Electrical and Electronic Equipment Instructions for use include information specified in 7 9 3 or identify where it can be found e g in a service manual Technical description oP TRF No IEC60601_1G SI Page 43 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark All essential data provided for safe operation transport storage and measures or conditions necessary for installing ME EQUIPMENT and preparing it for use including the following Provided within technical specification permissible environmental conditions of use Operating conditions including conditions for transport and storage specified within technical specification 0 to 40 C temperature Up to 90 relative humidity Up to 2000 meters Storage conditions 40 C to 80 C temperature 10 to 95 humidity all characteristics of ME EQUIPMENT including range s accuracy and precision of displayed values or where they can be found special installation requirements such as Not specified by the max permissible apparent impedance of manufacturer SUPPLY MAINS permissible range of values of inlet pressure and flow and chemical composition of cooling liquid used for cooling a description of means of isolating ME Desk top power supply EQUIPMENT from SUPPLY MAINS when such unit appliance coupler is means not in ME EQUIPMENT considered as disconnecting device Open f
68. risk management requirements of the standard were not addressed EUT not evaluated for use in conjunction with flammable agents 11 6 1 TABLE overflow spillage leakage ingress of water cleaning disinfection N E sterilization compatibility with substances Clause Test Name Test Condition Part under test Remarks TRF No IEC60601_1G SI gt Page 188 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product Shall be considered within end product investigation 11 6 2 RM RESULTS TABLE Overflow in ME equipment N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information The risk management requirements of the standard were not addressed 11 6 3 RM RESULTS TABLE Spillage on ME equipment and ME system N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information The risk management requirements of the standard were not addressed 11 6 5 RM RESULTS TABLE Ingress of water or particulate matter into ME N A EQUIPMENT and ME SYSTEMS Clause of
69. s PATIENT CONNECTIONS of a TYPE B APPLIED PART See Appended RM Results not PROTECTIVELY EARTHED are separated by one Table 8 5 2 2 MEANS OF PATIENT PROTECTION from metal ACCESSIBLE PARTS not PROTECTIVELY EARTHED N A N A N A N A except when metal ACCESSIBLE PART S A physically close to APPLIED PART and can be regarded as a part of APPLIED PART and RISK that metal ACCESSIBLE PART will make contact with a source of voltage or LEAKAGE A CURRENT above permitted limits is acceptably low LEAKAGE CURRENT tests conducted per 8 7 4 puremaa O per 8 9 and Tables 11 to 16 as applicable Themskwavacenentrucreviewed A connector on a PATIENT lead located at the end of the lead remote from N PATIENT with conductive part not separated from all PATIENT CONNECTIONS by one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to MAXIMUM MAINS VOLTAGE N N N A N A N A N A IA cannot be connected to earth or hazardous See Appended RM Results voltage while the PATIENT CONNECTIONS are in Table 8 5 2 3 contact With PATIENT cccceeceseesseeeeeeeeeeeeees No patient leads provided conductive part of connector not separated from all PATIENT CONNECTIONS did not come into contact with a flat conductive plate of not less than 100 mm diameter CLEARANCE between connector pins and a flat surface is at least 0 5 mm conductive part pluggable into a mains socket protected from m
70. the EUT wrapped into foil b Dielectric strength test was performed between output and input primary to secondary c Dielectric strength test was performed on the transformer transformer was removed from the EUT before performing dielectric strength test d Dielectric strength test was performed between primary and protective earth Dielectric strengths tests performed before humidity treatment after humidity treatment after temperature tests and after single faults tests EUT was evaluated as two means of operator protection 2 x MOOP between primary and secondary as two means of operator protection 2 x MOOP between primary and accessible plastic enclosure and as one means of operator protection 1 x MOOP between primary and protective earth 8 8 4 1 TABLE Resistance to heat Ball pressure test of thermoplastic parts P Fores jo Part material Test mo M diameter mmml information Approved thermoplastic materials used See Table 8 10 8 8 4 1 RM RESULTS TABLE Mechanical strength and resistance to heat N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 TRF No IEC60601_1G SI gt Page 152 of 279 Report No T223 0330 12 8 8 4 1 RM RESULTS TABLE Mechanical strength and resistance to heat N E Clause of Document Ref in RMF Result Remarks Verdict IS
71. to Pin 8 secondary windings Primary fuse See Class B Primary fuse No 10 min 165 See 25 Class B Primary fuse No 10 min 165 See 25 Supplementary information Loads on other windings between no load and their NORMAL USE load Short circuit applied at end of windings or at the first point that could be short circuited under SINGLE FAULT CONDITION Output voltage dropped to 0 V immediately Primary fuse opened immediately No high temperature rises observed No fire no hazard Output voltage dropped to 0 Vdc No high temperature rises were observed No fire no hazard 15 5 1 3 TABLE transformer overload test conducted only when protective device P under short circuit test operated Primary voltage most adverse value between 90 to 110 of RATED voltage v 90 Vac 264 Vac RATED input frequency HZ ssccesceeeseesseesseesesseesseeseeeseeesneesneesneeseseesneesseesneeseanseeseeeseeetoes 60 Hz 50 Hz Test current just below minimum current that would activate protective device amp achieve THERMAL STABILITY under method a A s sssssssunsenrunrunrunnununnunnunnunnunnunnunnunnnnnnnnn Test current based on Table 32 when protective device that operated under method a is external to transformer and it was shunted A ss sesssusensunnunrunrunnunnunnunrennnnnnnnnns a Class of Type of protective device Ma
72. to overheating h ME EQUIPMENT with tubular heating elements See Appended RM Results provided with protection against overheating in Table 15 4 2 1 h both leads where a conductive connection to earth could result in overheating as verified by review of design and RISK MANAGEMENT FILE 15 4 2 2 Temperature settings clearly indicated when No thermostats N A eans provided to vary setting of THERMOSTATS incorporated TRF No IEC60601_1G SIS Page 109 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Battery housings from which gases can escape during charging or discharging likely to result in a HAZARD ventilated to minimize RISK of accumulation and ignition as verified by review of design and RISK MANAGEMENT FILE ssseseeees Battery compartments prevent accidental short circuiting of battery when this could result in a HAZARDOUS SITUATION as verified by examination of design and RISK MANAGEMENT FILE Means provided to prevent incorrect connection of polarity when a HAZARDOUS SITUATION may develop by incorrect connection or replacement of a battery cccccsssseeeeeseeeees Overcharging of battery prevented by virtue of design when it could result in an unacceptable RISK as verified by review of design 00 Lithium batteries that could become a HAZARD complied with appropriate tests of IEC 60086 4 15 4 3 5 A properly RATED protective device provided wit
73. voltages specified in 4 10 or voltages marked on ME EQUIPMENT V ME EQUIPMENT marked with a RATED frequency Supply frequency 50 60 Hz range tested at the least favourable frequency Within the range HZ cescsessesseesseeseeeeeeeeeeeees ME EQUIPMENT with more than one RATED Supply voltage 100 240 Vac voltage or both a c d c tested in conditions see 5 4 related to the least favourable voltage nature of supply and type of current i Only AC supply voltage used for supplying power supply unit ME EQUIPMENT tested with alternative No such components ACCESSORIES and components specified in ACCOMPANYING DOCUMENTS to result in the least favourable conditionS ssssssssssnssnnennnnnnrnnennnne ME EQUIPMENT connected to a separate power Mains operated equipment supply as specified in instructions for use No accessories specified by the manufacturer Alternatively upon repair and modification of Considered the sample only the relevant tests conducted ME EQUIPMENT or parts thereof affected by See Appended RM Results climatic conditions were set up completely or Table 5 7 partially with covers detached and subjected to a humidity preconditioning prior to tests of Clauses 8 7 4 and 8 8 3 cccseceeseceeseeeeeeeeseeeeeeeee Complete power supply unit was subject to standard humidity preconditioning treatment Manually detachable parts removed and No such parts treated c
74. was 1 Type SJT SJTO SJO ST SO STO or equivalent flexible cord when exposed to abuse or similar multiple conductor appliance wiring material such as computer cable 2 The cable was as in item 1 above when not exposed to abuse or it was i Type SPT 2 SP 2 or SPE 2 or equivalent ii Type SVr SVRO SVE or equivalent flexible cord or similar multiple conductor appliance wiring material Or ii An assembly of insulated wires each with a nominal insulation thickness of 0 8 mm 1 32 inch or more enclosed in acceptable insulating tubing having a nominal wall thickness of 0 8 mm 1 32 inch or more Receptacles provided as part of ME N A EQUIPMENT or ME SYSTEMS for use in the patient care areas of pediatric wards rooms or areas are listed e g UL Certified tamper resistant or employ a listed e g UL Certified tamper resistant cover in accordance with NEC 8 11 3 2 Addition to agree with NEC Power supply cord was not N A part of the investigation The flexible cord is a type acceptable for the N A particular application and it is acceptable for use at a voltage not less than the rated voltage of the appliance and has an ampacity as in NEC not less than the current rating of the appliance CANADA NATIONAL DIFFERENCES to IEC 60601 1 Third edition National standard CAN CSA C22 2 No 60601 1 08 SIS Page 215 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Rema
75. was considered required Tests conducted in absence of satisfactory evidence for resistance to heat a ENCLOSURE and other external parts of See Table 8 8 4 1 insulating material except insulation of flexible cords and parts of ceramic material subjected to ball pressure test using apparatus of Fig 21 TRF No IEC60601_1G SI Page 59 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Remark b Parts of insulating material supporting See Table 8 8 4 1 uninsulated parts of MAINS PART subjected to ball pressure test in a except at 125 C 2 C or ambient indicated in technical description 2 C plus temperature rise determined during test of 11 1 of relevant part if higher C Test not performed on parts of ceramic material insulating parts of commutators brush caps and similar and on coil formers not used aS REINFORCED INSULATION Resistance to environmental stress sid to environmental stress Resistance E e characteristics and mechanical EUT is provided with plastic strength of all MEANS OF PROTECTION not likely to enclosure to cover all be impaired by environmental stresses internal parts including deposition of dirt resulting from wear of parts within EQUIPMENT potentially reducing CREEPAGE and CLEARANCES below 8 9 End product consideration for open frame and PCB mounted version Ceramic and similar materials not tightly No such materials used for sintered a
76. when a heating element or an intentionally weak part of a non SELF RESETTING THERMAL CUT OUT ruptured or current interrupted before THERMAL STABILITY without possibility of automatic restoration Test repeated on a second sample when interruption was due to rupture of a heating element or an intentionally weak part Both samples met 13 1 2 and open circuiting of a heating element or an intentionally weak part in second sample not considered a failure by itself b ME EQUIPMENT with heating elements tested per 11 1without adequate heat discharge and supply voltage set at 90 or 110 of RATED supply voltage least favourable of the two V Operating period stopped when a non SELF RESETTING THERMAL CUT OUT operated or current interrupted without possibility of automatic restoration before THERMAL STABILITY ME EQUIPMENT switched off as soon as THERMAL STABILITY established and allowed to cool to room temperature when current not interrupted Test duration was equal to RATED operating time for non CONTINUOUS OPERATION c Heating parts of ME EQUIPMENT tested with ME EQUIPMENT operated in NORMAL CONDITION at 110 of RATED supply voltage and as in 11 1 and 1 Controls limiting temperature in NORMAL CONDITION disabled except THERMAL CUT OUTS 2 When more than one control provided they were disabled in turn 3 ME EQUIPMENT operated at RATED DUTY CYCLE until THERMAL STABILITY achieved regardless of RATED operating time
77. 1 SEV 1011 and one of the following dimension sheets SEV 6533 2 2009 Plug type 11 L N 250V 10A SEV 6534 2 2009 Plug type 12 L N PE SEV 6532 2 2009 Plug type 15 3L N PE 250 400V 10A Supply cords of portable electrical appliances Power supply cord was not having a rated current not exceeding 16 A shall part of the investigation be provided with a plug complying with IEC 60884 1 3 ed am1 SEV 1011 and one of the following dimension SEV 5933 2 2009 Plug type 21 L N 250 V SEV 5934 2 2009 Plug type 23 L N PE 250 SEV 5932 2 2009 Plug type 25 3L N PE 250 400V 16A See TRF template regulatory requirements Switzerland on IECEE Website R R TRF EU DIFFERENCES Standard EN 60601 1 2006 A11 2011 SIS Page 223 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Annex ZZA Considered informative EN 60601 1 2006 A 11 2011 Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex l of the EC Directive 93 42 EEC except the following Essential Requirement 6a Essential Requirement 7 4 Essential Requirement 7 5 paragraph 2 amp 3 Essential Requirement 13 6 q Compliance with this standa
78. 1 0 T3 T3A T2 11 0 Vdc 1 3 A GTM21089 1512 X X T3 T3A T2 12 0 Vdc 1 25 A GTM21089 1815 2 0 T3 T3A T2 13 0 Vdc 1 15 A GTM21089 1815 1 2 T3 T3A T2 13 8 Vdc 1 09 A GTM21089 1815 1 0 T3 T3A T2 14 0 Vdc 1 07 A GTM21089 1815 X X T3 T3A T2 15 0 Vdc 1 2 A GTM21089 1818 2 0 T3 T3A T2 16 0 Vdc 1 2 A GTM21089 1818 1 0 T3 T3A T2 17 0 Vdc 1 0 A GTM21089 1818 X X T3 T3A T2 18 0 Vdc 1 0 A GTM21089 1824 5 0 T3 T3A T2 19 0 Vdc 0 95 A GTM21089 1824 4 0 T3 T3A T2 20 0 Vdc 0 90 A GTM21089 1824 X X T3 T3A T2 24 0 Vdc 0 75 A GTM21089 1948 20 4 T3 T3A T2 27 6 Vdc 0 65 A GTM21089 1948 18 0 T3 T3A T2 30 0 Vdc 0 60 A GTM21089 1948 12 0 T3 T3A T2 36 0 Vdc 0 50 A GTM21089 1948 X X T3 T3A T2 48 0 Vdc 0 39 A GTM21096 1003 F FW R RW 3 3 Vdc 2 6 A GTM21096 1305 1 0 F FW R RW 4 0 Vdc 2 6 A GTM21096 1305 X X F FW R RW 5 0 Vdc 2 6 A GTM21096 1506 X X F FW R RW 6 0 Vdc 2 6 A GTM21096 1509 2 0 F FW R RW 7 0 Vdc 2 0 A TRF No IEC60601_1G Report No T223 0330 12 SL gt Page 4 of 279 Report No T223 0330 12 GTM21096 1509 1 0 F FW R RW 8 0 Vdc 1 8 A GTM21096 1509 X X F FW R RW 9 0 Vdc 1 7
79. 1 6 7 and documented according to ISO 11134 S9 11135 or ISO 11137 as appropriate After the test ME EQUIPMENT complied with the See appended Tables 8 7 appropriate dielectric strength and LEAKAGE 8 8 3 and 11 6 CURRENT tests and there was no deterioration resulting in an unacceptable RISK ccseee RISKS associated with compatibility of See Appended RM Results substances used with ME EQUIPMENT addressed Table 11 6 8 in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE ME EQUIPMENT ME SYSTEM and ACCESSORIES No such parts coming into direct or indirect contact with biological tissues cells or body fluids assessed and documented per ISO 10993 Interruption and restoration of power supply Shall be evaluated during did not result in a HAZARDOUS SITUATION except end medical product interruption of its intended function approval Power supply unit is not end medical product RISKS associated with accuracy of controls and See Appended RM Results instruments stated in RISK MANAGEMENT PROCESS Table 12 1 confirmed by RISK MANAGEMENT FILE review RISK of poor USABILITY including identification See Report based on IEC marking and documents addressed in a 60601 1 6 USABILITY ENGINEERING PROCESS as confirmed by review of provided records The need for alarm systems as a means of RISK See Report based on IEC CONTROL and RISKS associated with operation or 60601 1
80. 223 0330 12 IEC 60601 1 Requirement Test Result Remark ISO 1000 applied for application of S units N A their multiples and certain other units All Markings in Sub clause 7 4 complied with See Appended Tables 7 1 2 N A tests and criteria of 7 1 2 and 7 1 3 and 7 1 3 N A mo fws O o O a Markings used to convey a warning See Appended RM Results N A prohibition or mandatory action mitigating a Table 7 5 RISK not obvious to OPERATOR are safety signs from ISO 7010 Affirmative statement together with safety sign placed in instructions for use if insufficient space on ME EQUIPMENT No safety signs provided EUT is medical in power supply unit Safety notices include appropriate precautions N A or instructions on how to reduce RISK S Safety signs including any supplementary text N A or symbols described in instructions for use 7 6 Symbols P 7 6 1 Meanings of symbols used for marking Provided within safety described in instructions for use instructions 7 6 2 Symbols required by this standard conform to According to Annex D IEC or ISO publication referenced 7 6 3 Symbols used for controls and performance conform to the IEC or ISO publication where symbols are defined as applicable 7 7 Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR identified by Green yellow colour of green and yellow insulation insulation of protective conductor relevant for models with protective earth Insulati
81. 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ME EQUIPMENT or its parts intended to be No such parts sterilized classified according to method s of sterilization in instructions for use ME EQUIPMENT and ME SYSTEMS intended for use EUT was not evaluated for in an OXYGEN RICH ENVIRONMENT Classified for use in an oxygen rich such use and complied with 11 2 2 environments CONTINUOUS or Non CONTINUOUS OPERATION Power supply unit is designed for continuous operation No markings provided ME EQUIPMENT IDENTIFICATION MARKING AND DOCUMENTS RISK of poor USABILITY associated with the See Attachment design of ME EQUIPMENT S identification and marking addressed in a USABILITY ENGINEERING PROCESS e202 veces cuataedssccucastenscaresseadsssecesctestantcavoereees EUT is medical power supply unit Legibility of Markings Test for Markings See Appended Table 7 1 2 specified in Clause 7 2 7 6 ccssscseseeseeeseees Legibility of markings performed on desk top version Not applicable for open frame and PCB mounted version Required markings can be removed only with a TOOL or by appreciable force are durable and remain CLEARLY LEGIBLE during EXPECTED SERVICE LIFE of ME EQUIPMENT in NORMAL USE a After tests adhesive labels didn t loosen up See appended Tables 7 1 3 or curl up at edges and markings complied with and 8 10 requirements in Clause 7 1 2 cs ses
82. 4 4 TRF No IEC60601_1G SI gt Page 190 of 279 Report No T223 0330 12 11 6 8 RM RESULTS TABLE Compatibility with substances used N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product Shall be considered within end product investigation 12 1 RM RESULTS TABLE Accuracy of controls and equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No controls provided Power supply unit is part of the investigation 12 3 RM RESULTS TABLE Alarm systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 TRF No IEC60601_1G SI gt Page 191 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 12 3 RM RESULTS TABLE Alarm systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary information No alarm incorporated 12 4 1 RM RESULTS TABLE
83. 601 1 Requirement Test Result Remark C1 1xMOOP lll 273 480 2 9 2 1 4 0 4 0 Measured between primary and PE Sufficient D1 2 x MOOP IIIb 247 480 5 0 4 2 7 6 7 6 Measured on the transformer Sufficient D2 2 x MOOP IIIb 247 480 5 0 4 2 8 0 6 1 Measured on PCB Sufficient TRF No IEC60601_1G i Page 17 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information EUT was evaluated as two means of operator protection 2 x MOOP between primary and secondary and between primary and accessible outer plastic enclosure and as one means of operator protection 1 x MOOP between primary and protective earth 1 The top enclosure is secured to bottom enclosure by ultrasonic welding relevant for desk top version Primary bulk capacitor C9 is fixed to primary inductor LF1 with glue to prevent bending and reduction of the safety distances See enclosed pictures of the unit for details Minimum clearance distance between primary heatsink and accessible enclosure Minimum creepage distance Measured between primary diode D3 and accessible enclosure 2 Triple insulated wire used for secondary windings Transformer core is covered with insulation tape on the bottom side to achieve sufficient distance between transformer core and secondary pins of the transformer Transformer core is conside
84. 7 0 83 5 89 8 93 5 97 7 91 8 90 8 94 2 78 3 75 3 74 9 77 1 100 1 96 3 93 3 96 1 82 5 77 6 72 2 74 3 79 7 76 2 74 1 76 2 68 4 65 7 66 7 68 0 72 2 69 8 70 0 71 8 74 3 70 9 68 9 70 7 0 337 0 292 0 155 0 143 5 0 5 0 5 0 5 0 2 6 2 6 2 6 2 6 120 90 120 90 130 100 105 120 120 130 130 105 130 95 Supplementary information Temperature rises of the transformer was measured with thermocouples Class B transformer provided inside the unit 130 C 10 C 120 C Inductor NF1 and L1 are assumed to be Class A 105 C 10 C 95 C The printed circuit board PCB is rated 130 C Max temperature determined in accordance with 11 1 3e 1 Plastic enclosure of the EUT is assumed to be touched by the operator for a time t t lt 1 second therefore limit 86 C applied for external plastic enclosure Power supply unit is not intended to be moved from one to another location during operation Test performed on desk top power supply unit to cover all versions TRF No IEC60601_1G SI Page 181 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 1 1 TABLE Thermal requirements Model GTM21089 1305 5 0 Vdc 2 6 A Maximum measured temperature T of Max measured temperature C Allowe part at d Tmax C
85. 9 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark A Y2 capacitor complying with IEC 60384 14 See Appended Tables 8 8 3 and passing dielectric strength test for one and 8 10 MEANS OF OPERATOR PROTECTION considered equivalent to one MEANS OF OPERATOR PROTECTION Approved Y1 capacitor provided between primary and secondary circuit See list of critical components A Y1 capacitor complying with IEC 60384 14 See Appended Tables 8 8 3 and having passed dielectric strength test for and 8 10 two MEANS OF OPERATOR PROTECTION considered equivalent to two MEANS OF OPERATOR PROTECTION Approved Y1 capacitor provided between primary and secondary circuit See list of critical components Two capacitors used in series each RATED for Single Y1 capacitor total WORKING VOLTAGE across the pair and have provided between primary the same NOMINAL capacitance and secondary circuit Voltage Total Working V and C Nominal uF Daware z Points at which impedances of components CREEPAGE CLEARANCES PROTECTIVE EARTH CONNECTIONS or insulation prevent ACCESSIBLE PARTS from exceeding limits in 8 4 examined whether a failure at any of these points is to be regarded as a NORMAL or SINGLE FAULT CONDITION A MEANS OF PROTECTION protecting APPLIED PARTS or parts identified by 4 6 as parts subject to the same requirements considered MEANS OF PATIENT PROTECTION ccccceeeceeeeeeeeeeeerees A MEANS OF PROTECTION protec
86. AD simulating PATIENT Or OPERATOR dropped from 150 mm above seat area on an area of support suspension a PATIENT or OPERATOR can sit 9 8 4 Systems with MECHANICAL PROTECTIVE DEVICES 4 N A 9 8 4 1 a A MECHANICAL PROTECTIVE DEVICE provided See Appended RM Results when a support system or its parts impaired Table 9 8 4 1 by wear have a TENSILE SAFETY FACTOR 2 to values in Table 21 rows 5 and 6 but less than BAIN A vaerei ct severe aaia craved enea deveees b MECHANICAL PROTECTIVE complies with the N A requirements as follows IA Designed based on TOTAL LOAD and N includes effects of SAFE WORKING LOAD when applicable Has TENSILE SAFETY FACTORS for all parts not less than Table 21 row 7 Activated before travel movement produced an unacceptable RISK Takes into account Clauses 9 2 5 and 9 8 4 3 Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing svvceees sticecsstecees stteceessetvesssteesenstteees Activation of MECHANICAL PROTECTIVE DEVICE is made obvious to OPERATOR when ME EQUIPMENT can still be used after failure of suspension or actuation means and activation of a MECHANICAL PROTECTIVE DEVICE e g a secondary cable MECHANICAL PROTECTIVE DEVICE requires use of a TOOL to be reset or replaced N A Further use of ME EQUIPMENT not possible See Appended RM Results N A until replacement of MECHANICAL PROTECTIVE Tab
87. ATOR PATIENT and others from TRAPPING ZONES exceeded values in ISO 13852 Distances measured from expected positions of OPERATOR PATIENT and others near EQUIPMENT in NORMAL USE or under foreseeable N A A TRAPPING ZONE considered not to present a See Appended Table 15 3 N A MECHANICAL HAZARD when GUARDS and protective measures were of robust construction not easy to bypass or render non operational and did not introduce additional unacceptable RISK based on results of applicable tests in 15 3 for ENCLOSURES FIXED GUARDS held in place by systems that cannot be dismantled without a TOOL ovable GUARDS that can be opened without a See Appended RM Results TOOL remained attached when GUARD was open Table 9 2 2 4 3 they are associated with an interlock preventing relevant moving parts from starting to move while TRAPPING ZONE is accessible and stops movement when the GUARD is opened absence or failure of one of their components prevents starting and stops moving parts Movable GUARDS complied with all applicable tests as confirmed by review of RISK MANAGEMENT FILE Protective measures provided in control See Appended RM Results system prevented moving parts from starting Table 9 2 2 4 4 to move while in reach of persons 0 protective measures prevented TRAPPING ZONE from reach or when it was reached system movement stopped once ME EQUIPMENT started to move and in the latt
88. B CD where GTM2 denotes version of the power supply unit 41096 denotes family designation YY denotes output power of the power supply unit in watts ZZ denotes output voltage of the power supply unit in volts A B denotes optional deviation subtracted from standard output voltage in 0 1 volt increments C denotes type of power supply unit F Open frame power supply unit R PCB mounted power supply unit D denotes protection class of the power supply unit Blank Class construction power supply unit protection class not defined W Class II construction power supply unit protection class not defined For details see next page and copy of marking plate and summary of testing Ratings iiss tec ccieesccectetesteeeies etcereeeesecees I P 100 240 V 50 60 Hz 500 250 mA O P See table on next pages TRF No IEC60601_1G SLE Page 3 of 279 Model name Output ratings output DC voltage output current GTM21089 1003 T3 T3A T2 3 3 Vdc 2 6 A GTM21089 1305 1 0 T3 T3A T2 4 0 Vdc 2 6 A GTM21089 1305 X X T3 T3A T2 5 0 Vdc 2 6 A GTM21089 1506 X X T3 T3A T2 6 0 Vdc 2 6 A GTM21089 1509 2 0 T3 T3A T2 7 0 Vdc 2 0 A GTM21089 1509 1 0 T3 T3A T2 8 0 Vdc 1 8 A GTM21089 1509 X X T3 T3A T2 9 0 Vdc 1 7 A GTM21089 1512 2 0 T3 T3A T2 10 0 Vdc 1 5 A GTM21089 1512
89. CLEARANCE applied as min CREEPAGE DISTANCE 8 9 1 5 ME EQUIPMENT RATED to operate at an altitude of EUT was evaluated for use 2000 m up to 2000 meters ME EQUIPMENT RATED to operate at an altitude specified by MANUFACTURER IM sseseeeeeeeeeeeees i Operating altitude corresponding to actual air pressure for ME EQUIPMENT intended for pressurized environments e g aircraft used to determine multiplication factor from Table 8 and AIR CLEARANCE was multiplied by this factor CREEPAGE DISTANCES not subjected to multiplication factors but were at least as large as the resulting value for AIR CLEARANCE When WORKING VOLTAGE was between those in Tables 11 to 16 inclusive CREEPAGE and CLEARANCES calculated as follows CREEPAGE DISTANCES determined by linear See Insulation interpolation between the nearest two values Diagram Table and the calculated spacing rounded off to the next higher 0 1 mm increment mm Considered CLEARANCES for PEAK WORKING VOLTAGES above See Insulation 2800 V peak or d c determined by linear Diagram Table interpolation between the nearest two values and the calculated spacing rounded off to the next higher 0 1 mm increment mm 0 No such voltages obtained during normal use of the equipment for AIR CLEARANCES corresponding to PEAK No such voltages obtained WORKING VOLTAGE up to 2800 V peak or d c the during normal use of the higher of the two va
90. CLEARANCES complied with 8 9 ee It is CLASS I and PROTECTIVE EARTH CONDUCTOR is connected to earthing contacts in socket outlets PROTECTIVE EARTH TERMINALS and PROTECTIVE EARTH CONNECTIONS comply with 8 6 except total impedance for ME SYSTEM was up to 400 mQ or higher when conditions of 8 6 4 b met mQ MAINS TERMINAL DEVICES and wiring complied N A with 8 11 4 when applicable RATINGS of components are not in conflict See appended Table 8 10 N A With conditions Of USE ecececeeeeeeeeeeeeeeneeeeeeeeee TRF No IEC60601_1G MULTIPLE SOCKET OUTLET is a Separate item or N A an integral part of ME EQUIPMENT or non ME EQUIPMENT SI Page 117 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Electrical terminals and connectors of N A MULTIPLE SOCKET OUTLETS prevent incorrect connection of accessible connectors removable without a TOOL d Additional requirements applied when MULTIPLE SOCKET OUTLET combined with a separating transformer Separating transformer complied with IEC See appended Table 8 10 61558 2 1 except requirements of maximum RATED output power of 1 kVA and degree of protection IPX4 were not applied 05 Separating transformer is CLASS Degree of protection against ingress of water specified as in IEC 60529 Separating transformer assembly marked according to 7 2 and 7 3 MULTIPLE SOCKET OUTLET per
91. Case bottom 12 PCB 13 Inside enclosure Input current A Output voltage Vdc Output current A Duration min Supplementary information Temperature rises of the transformer was measured with thermocouples Class B transformer provided inside the unit 130 C 10 C 120 C Inductor NF1 and L1 are assumed to be Class A 105 C 10 C 95 C The printed circuit board PCB is rated 130 C Max temperature determined in accordance with 11 1 3e 1 Plastic enclosure of the EUT is assumed to be touched by the operator for a time t t lt 1 second therefore limit 86 C applied for external plastic enclosure Power supply unit is not intended to be moved from one to another location during operation Test performed on desk top power supply unit to cover all versions It is not possible to state compliance using a 95 coverage probability for the expanded uncertainty Expanded uncertainty U 3 C coverage factor kp 2 confidence level 95 TRF No IEC60601_1G SI gt Page 184 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 1 1 RM RESULTS TABLE Maximum temperature during normal use N E Table 23 or 24 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary infor
92. Desktop power supply unit appliance coupler is considered as disconnecting device Open frame PCB mounted power supply unit end product consideration PERMANENTLY INSTALLED ME EQUIPMENT connected EUT is not permanently to a poly phase SUPPLY MAINS equipped with a installed equipment device not interrupting neutral conductor provided local installation conditions prevent voltage on neutral conductor from exceeding limits in 8 4 2 c b Means of isolation incorporated in ME See appended Table 8 10 EQUIPMENT and external means described in technical description c A SUPPLY MAINS switch used to comply with See appended Table 8 10 8 11 1 a complies with CREEPAGE and CLEARANCES in IEC 61058 1 for a MAINS TRANSIENT VOLTAGE Of 4 KV uo ccessseeeeeeseseeeeneeeeeees d A SUPPLY MAINS switch not incorporated in a POWER SUPPLY CORD or external flexible lead e Direction of movement of actuator of a SUPPLY MAINS switch used to comply with 8 11 1 a complies with IEC 60447 Desk top power supply unit appliance coupler is considered as disconnecting device used in non PERMANENTLY INSTALLED ME EQUIPMENT to isolate it from SUPPLY MAINS considered to comply with 8 11 1 a Open frame PCB mounted power supply unit end product consideration g A fuse or a semiconductor device not used as an isolating means h ME EQUIPMENT not provided with a device causing disconnection of ME EQUIPMENT from SUPPLY MAINS by p
93. Document No amp paragraph 4 2 4 3 TRF No IEC60601_1G SIS Page 172 of 279 Report No T223 0330 12 9 6 1 RM RESULTS TABLE Acoustic energy General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 6 2 2 RM RESULTS TABLE Infrasound and ultrasound energy N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 7 2 RM RESULTS TABLE Pneumatic and hydraulic parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 7 4 RM RESULTS TABLE Pressure rating of ME equipment parts N A TRF No IEC60601_1G SIS Page 173 of 279 Report No T223 0330 12 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 7 5 TABLE Pressure vessels N A Hydraulic Vessel Burst Permanent Vessel fluid Pneumatic or Deformation substance Suitable Media and
94. Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information No protection against ingress of water provided ordinary equipment TRF No IEC60601_1G SI gt Page 189 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 6 6 RM RESULTS TABLE Cleaning and disinfection of ME equipment and ME N E systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product Shall be considered within end product investigation 11 6 7 RM RESULTS TABLE Sterilization of ME equipment and ME systems N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information The risk management requirements of the standard were not addressed EUT is not end medical product Shall be considered within end product investigation 11 6 8 RM RESULTS TABLE Compatibility with substances used N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3
95. ENCLOSURE providing protection against penetration of gases or vapours into ME EQUIPMENT or its parts possible only with a TOOL b ENCLOSURE complies with requirements to See appended Table 8 10 minimize arcing and sparking due to penetration of foreign Objects no openings on top covers of ENCLOSURE except for openings for controls covered by control knobs TRF No IEC60601_1G SIS Page 120 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark openings in side covers prevented penetration of a solid cylindrical test rod of 4 mm in diameter applied in all possible directions without appreciable force openings in base plates prevented penetration of a solid cylindrical test rod of 12 mm in diameter applied in all directions without appreciable force c Short circuiting conductor s to a conductive part without presence of explosive gasses where insulation may contact a part containing a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE ignitable gases alone or oxygen did not result in loss of integrity of the part an unacceptable temperature or other HAZARD a Electrostatic charges prevented on CATEGORY AP and APG ME EQUIPMENT by a combination of appropriate measures Use of antistatic materials with a limited electrical resistance as specified in G 4 3 b Provision of electrically conductive paths from ME EQUIPMENT or its parts to a conductive floor prot
96. ENT is subjected to unacceptable RISKS due to proximity of moving parts removal of normal exit routes or other HAZARDS prevented Measures provided to reduce RISK to an acceptable level when after removal of counterbalanced parts other parts of ME EQUIPMENT can move in a hazardous way Rough surfaces sharp corners and edges of See Appended RM Results ME EQUIPMENT that could result in an Table 9 3 unacceptable RISK avoided or covered No rough surfaces no sharp corners and no sharp edges ME EQUIPMENT other than FIXED and hand held Applicable for desk top for placement on a surface did not version overbalance tip over or move unexpectedly to the degree that it could present an unacceptable RISK to PATIENT Or OPERATOR aS tested in 9 4 2 to 9 4 4 Not overbalanced when tilted through an angel of 10 ME EQUIPMENT or its parts did not overbalance when prepared per ACCOMPANYING DOCUMENTS or when not specified as in 9 4 2 2 and placed on a 10 inclined plane from horizontal consisting of a hard and flat surface e g Not overbalanced when tilted concrete floor covered with 2 to 4 mm thick through an angel of 10 vinyl material Applicable for desk top version ME EQUIPMENT or its parts prepared based on a to g inclusive did not overbalance when placed in different positions of NORMAL USE except transport positions on a 5 inclined plane from horizontal hard and flat surface A warning provide
97. ESSENTIAL PERFORMANCE or when application of ISO 14971 showed that See Appended RM Results failure of PESS does not lead to unacceptable Table 14 1 Every PROCESS has been followed throughout the PEMS DEVELOPMENT LIFE CYCLE and a RECORD of PROCESS has been made available as confirmed by RISK MANAGEMENT FILE REVIEW and assessment of PROCESSES cited in this Clause MANUFACTURER considered the need for additional RISK CONTROL measures when unable to follow all PROCESSES identified in Clause 14 for each constituent component of PEMS as confirmed by RISK MANAGEMENT FILE review and assessment of PROCESSES cited in this Clause Documents produced from application of Clause 14 are maintained and form a part of RISK MANAGEMENT FILE in addition to RECORDS and documents required by ISO 14971 RISK MANAGEMENT plan required by 3 5 of ISO 14971 includes reference to PEMS VALIDATION At each milestone activities to be completed and VERIFICATION methods to be applied to activities have been defined Each activity including its inputs and outputs defined and each milestone identifies RISK MANAGEMENT activities that must be completed before that milestone PEMS DEVELOPMENT LIFE CYCLE tailored for a specific development by making plans detailing activities milestones and schedules A documented system for problem resolution within and between all phases and activities of PEMS DEVELOPMENT LIFE CYCLE has been developed and maintain
98. F 402 V 62 5kS s Auto 62 5kS s Auto Edgo CH1 F 402 V Edgo CH1 F 402 V Auto 62 5kS s Auto 200ns dv il j po 200ns dv TABLE Internal capacitive circuits measurement of residual voltage or calculation of the stored charge in capacitive circuits i e accessible capacitors or circuit parts after de energizing ME EQUIPMENT Maximum allowable residual voltage V Maximum allowable stored charge when residual voltage exceeded 60 V Description of the capacitive circuit Measured residual Calculated stored i e accessible capacitor or circuit voltage V charge uC parts Remarks Supplementary information 8 5 2 2 RM RESULTS TABLE Type B applied parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 TRF No IEC60601_1G SIS Page 144 of 279 Report No T223 0330 12 8 5 2 2 RM RESULTS TABLE Type B applied parts N A Clause of Document Ref in
99. G Table 9 2 1 DOCUMENTS or under foreseeable misuse RISKS associated with moving parts reduced to an acceptable level No moving parts provided Risk from contact with moving parts reduced to an acceptable level using protective measures access function shape of parts energy speed of motion and benefits to PATIENT considered RESIDUAL RISK associated with moving parts considered acceptable when exposure was needed for ME EQUIPMENT to perform its function in instructions for use when HAZARDS persisted after implementing all reasonable protective measures ME EQUIPMENT with a TRAPPING ZONE complied EUT is medical power supply with one or more of the following as feasible unit No trapping zones Gaps in Clause 9 2 2 2 or Safe distances in Clause 9 2 2 3 or GUARDS and protective measures in 9 2 2 4 or Continuous activation in Clause 9 2 2 5 TRF No IEC60601_1G SIS Page 72 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Control of relevant motion complied with 9 2 2 6 when implementation of above protective measures were inconsistent with INTENDED USE of ME EQUIPMENT or ME SYSTEM A TRAPPING ZONE considered not to present a See appended Table 9 2 2 2 MECHANICAL HAZARD when gaps of TRAPPING ZONE complied with dimensions per Table 20 A TRAPPING ZONE considered not to present a See appended Table 9 2 2 2 MECHANICAL HAZARD when distances separating OPER
100. I Page 105 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Impact test conducted by subjecting a See Appended Table 15 3 complete ENCLOSURE or its largest non and RM Results Table 15 3 3 reinforced area except for HAND HELD ME EQUIPMENT and parts to a free falling 500 g 25 g solid smooth steel ball approx 50 mm in diameter from a height of 1 3 M esseeeeeeeerees Test not applied to flat panel displays platen No such parts provided glass of ME EQUIPMENT or cathode ray tubes No damage resulting in an unacceptable RISK No damage of the enclosure sustained as shown in RISK MANAGEMENT FILE no cracks EUT is provided with enclosure with adequate strength and rigidity The risk management requirements of the standard were not addressed Test performed on desk top version 15 3 4 Drop test N A Sample of HAND HELD ME EQUIPMENT and HAND See Appended Table 15 3 HELD part with SAFE WORKING LOAD allowed to fall freely once from each of 3 different positions as in NORMAL USE from height specified in ACCOMPANYING DOCUMENTS or from 1 m onto a 50 mm 5 mm thick hardwood board lying Hat on a concrete or rigid DASC cccccessseeeeneeeeeees Sample of PORTABLE ME EQUIPMENT and PORTABLE See Appended Table 15 3 part with SAFE WORKING LOAD lifted to a height and RM Table 15 3 4 2 as in Table 29 above a 50 5 mm thick hardwood board lying flat on a concrete floor or rigid base droppe
101. IEC or ISO standard NOTE 1 For the components it is not necessary to carry out identical or equivalent tests already performed to check compliance with the component standard b where there is no relevant CSA IEC or ISO Considered standard the requirements of this standard have to be applied NOTE 2 If there are neither requirements in this standard nor in a CSA IEC or ISO standard any other applicable source e g standards for other types of devices national standards could be used to demonstrate compliance with the RISK MANAGEMENT PROCESS 4 10 2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS and shall be in accordance with the Canadian Electrical Code CEC Part 1 CSA C22 1 A PROTECTIVE EARTH CONDUCTOR ora See enclosed pictures of the PROTECTIVE EARTH CONNECTION or unit for details insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 2 No 21 and CSA C22 2 No 49 Allowable values Considered Allowable values shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 8 11 3 2 POWER SUPPLY CORDS Types NA SIS Page 219 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark a The MAINS PLUG of non PERMANENTLY Power supply cord was not INSTALLED EQUIPMENT shall be p
102. IEC60601_1G SL gt Page 8 of 279 Report No T223 0330 12 Tests performed name of test and test clause Verdict 4 11 Power Input P 7 1 3 Durability of marking P 8 4 Limitation of voltage current and energy P 8 5 5 Defibrillation proof applied parts N A 8 6 4 Impedance and current carrying capability of protective earth P connections 8 7 4 5 Earth Leakage Current P 8 7 4 6 Touch Current P 8 7 4 7 Patient Leakage Current N A 8 7 4 8 Patient Auxiliary Current N A 8 7 4 9 Multiple Patient Connections N A 8 8 3A Dielectric Strength test of solid insulation materials with safety P functions MOOP 8 8 3B Dielectric Strength test of solid insulation materials with safety N A functions MOPP 8 9 2 Short circuits in Mains part over creepage and clearance distances P 8 9 3 2 Thermal Cycling Test on one sample of insulation compound forming N A solid insulation between conductive parts 8 9 3 4 Thermal Cycling test on one Sample of Cemented joint N A 9 2 2 2 Measurement of gap a according to table 20 ISO 13452 1996 N A 10 1 1 Measurement of X radiation N A 11 1 Excessive temperatures in ME EQUIPMENT P 11 2 2 1 Existence of ignition sources N A 13 1 Power or energy dissipation N A 13 2 Single Fault conditions P 15 3 Mechanical strength P 15 4 6 Actuating parts of controls N A 15 5 1 2 Transformer short circuit P 15 5 1 3 Transformer ove
103. INS PART a Cross sectional area of internal wiring in a No internal wiring in a mains MAINS PART between MAINS TERMINAL DEVICE and part provided protective devices is not less than minimum required for POWER SUPPLY CORD as in clause 814 3 3 mMm CU viniani iiia Only PCB tracks provided fuses or OVER CURRENT RELEASES omitted due N A to provision of two MEANS OF PROTECTION between all parts of opposite polarity within MAINS PART and between all parts of MAINS PART and earth and such provisions continued within all components ae hall TRF No IEC60601_1G SI gt Page 71 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark b Cross sectional area of other wiring in MAINS See appended Table 8 10 PART and sizes of tracks on printed wiring PCB tracks provided circuits sufficient to prevent fire in case of fault CUITONTS enri te eee dat secede ch aneia aiai When necessary ME EQUIPMENT connected to a SUPPLY MAINS with max available short circuit fault and subsequent simulation of a fault in a single insulation in MAINS PART did not result in any of the HAZARDOUS SITUATIONS in 13 1 2 PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT AND ME SYSTEMS ME EQUIPMENT complies with Clause 4 for design and manufacture and mechanical strength 15 3 HAZARDS associated with moving parts When ME EQUIPMENT with moving parts See Appended RM Results PROPERLY INSTALLED used per ACCOMPANYIN
104. L documented in technical description type and full rating of fuses used in SUPPLY See Appended RM Results MAINS external to PERMANENTLY INSTALLED ME Table 7 9 3 2 EQUIPMENT when type and rating of fuses are not apparent from information on RATED current and mode of operation of ME EQUIPMENT EUT is not permanently installed equipment a statement for ME EQUIPMENT with a non Non detachable power DETACHABLE POWER SUPPLY CORD if POWER SUPPLY Supply cord not provided CORD is replaceable by SERVICE PERSONNEL and if so instructions for correct connection and anchoring to ensure compliance with 8 11 3 instructions for correct replacement of interchangeable or detachable parts specified by MANUFACTURER as replaceable by SERVICE PERSONNEL and warnings identifying nature of HAZARD when EUT is maintence free replacement of a component could result in an unacceptable RISK and when replaceable by SERVICE PERSONNEL all information necessary to safely replace the component Technical description indicates MANUFACTURER will provide circuit diagrams component part lists descriptions calibration instructions to assist to SERVICE PERSONNEL in parts repair TRF No IEC60601_1G Clause Page 45 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict Means used to comply with requirements of Desk top power supply 8 11 1 clearly identified in technical description unit appli
105. M Results Table 15 4 4 The risk management requirements of the standard were not addressed No heaters provided Requirement not applied to heated stylus pens N A for recording purposes SIS Page 110 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Indicator lights provided on ME EQUIPMENT to Power supply unit without indicate an output exists where an accidental power on indicator light or prolonged operation of output circuit could constitute a HAZARDOUS SITUATION Power supply unit is not end medical product End product consideration E O Colours of indicator lights complied with 7 8 1 End product consideration N A Charging mode visibly indicated in ME No charging mode provided EQUIPMENT incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE 15 4 5 RISKS associated with pre set controls See Appended RM Results addressed in RISK MANAGEMENT PROCESS when Table 15 4 5 applicable as verified by review of RISK MANAGEMENT FILE 0 0ceseecceeeseecceeeseaeeeeeseaeeeensees 15 4 6 Actuating parts of controls of ME EQUIPMENT 15 4 6 1 a Actuating parts cannot be pulled off or No actuating parts of N A loosened up during NORMAL USE controls provided N A b Indication of scales e g on off positions etc always corresponds to position of controls with adjustment that can result in a HAZARDOUS SITUATION for PATIENT or OPERATOR while ME EQUIPMENT is
106. MAL and SINGLE FAULT CONDITIONS identified in 11 2 3 ceeeees i 2 Max oxygen concentration measured until it did not exceed 25 in ventilated compartments with parts that can be a source of ignition only in SINGLE FAULT CONDITION and can be penetrated by oxygen due to an undetected leak ussssnusseunsnrennnnrnnnnnnnnnnnnnnne 3 A compartment with parts or components that can be a source of ignition only under SINGLE FAULT CONDITION separated from another compartment containing an OXYGEN RICH ENVIRONMENT by sealing all joints and holes for cables shafts or other purposes TRF No IEC60601_1G SIS Page 90 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Effect of possible leaks and failures under See Attachment SINGLE FAULT CONDITION that could cause ignition evaluated using a RISK ASSESSMENT to determine maintenance intervals by examination of documentation and RISK MANAGEMENT FILE 4 Fire initiated in ENCLOSURE of electrical See Attachment components in a compartment with OXYGEN RICH ENVIRONMENT that can become a source of ignition only under SINGLE FAULT CONDITIONS self extinguished rapidly and no hazardous amount of toxic gases reached PATIENT as determined by analysis of gases 11 2 2 2 RISK of ignition under least favourable conditions did not occur and oxygen concentration did not exceed 25 in immediate surroundings due to location of external
107. ME SYSTEM according to relevant standards not repeated RISK MANAGEMENT methods optionally used by MANUFACTURER of an ME SYSTEM reconfigurable by RESPONSIBLE ORGANIZATION or OPERATOR to determine configurations with highest Risks and measures to ensure any configuration of ME SYSTEM will not present unacceptable RISKS Non ME EQUIPMENT used in ME SYSTEM complied with applicable IEC or Iso safety standards Equipment relying only on BASIC INSULATION for protection against electric shock not used in ME SYSTEM ACCOMPANYING DOCUMENTS of an ME SYSTEM Documents containing all data necessary for ME SYSTEM to be used as intended by MANUFACTURER including a contact address accompany ME SYSTEM or modified ME SYSTEM N A ACCOMPANYING DOCUMENTS regarded as a part of ME SYSTEM ACCOMPANYING DOCUMENTS are optionally N A provided in electronic format e g electronic file format or CD ROM and ME SYSTEM is capable of displaying or printing these documents a ACCOMPANYING DOCUMENTS provided for each N A item of ME EQUIPMENT supplied by MANUFACTURER b ACCOMPANYING DOCUMENTS provided for each N A item of non ME EQUIPMENT supplied by MANUFACTURER o m c the required information is provided specifications instructions for use as N A intended by MANUFACTURER and a list of all items forming the ME SYSTEM instructions for installation assembly and N A modification of ME SYSTEM to ensure continued compliance with this standard
108. MOOP 480 V peak 3 000 Vac No break secondary down of the See b below insulation Primary to 2 x MOOP 480 V peak 3 000 Vac No break secondary down of the See c below insulation Primary to protective 1x MOOP 480 V peak 1 707 Vac No break earth down of the See d below insulation Insulation foil 2 x MOOP 480 V peak 3 000 Vac No break between PCB and down of the primary metal shield insulation TRF No IEC60601_1G SI Page 151 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Silpad insulation 2 x MOOP 480 V peak 3 000 Vac No break placed over the D8 down of the insulation Insulation tape 3 2 x MOOP 480 V peak 3 000 Vac No break layers provided over down of the silpad placed over insulation the D8 therefore 2 layers tested for reinforced insulation See information Alternatively per the Table i e __ dc a d c test voltage equal to the peak value of the a c test voltage used A Immediately after humidity treatment of 5 7 ME EQUIPMENT de energized B after required sterilization PROCEDURE ME EQUIPMENT de energized C after reaching steady state operating temperature as during heating test of 11 1 1 and D after relevant tests of 11 6 i e overflow spillage leakage ingress of water cleaning disinfection and sterilization a Dielectric strength test was performed between input primary and enclosure of
109. O 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 Supplementary information 8 9 2 TABLE Short circuiting of each single one of the CREEPAGE DISTANCES and AIR N A CLEARANCES for insulation in the MAINS PART between parts of opposite polarity in lieu of complying with the required measurements in 8 9 4 Test in lieu of HAZARDOUS SITUATION Specific areas of circuits short CREAS ee Cel Cals paca Remarks cleculted andteetconaltions DISTANCE or AIR shock hazard explosion CLEARANCE discharge of parts etc Yes No Supplementary information Note 1 AC AIR CLEARANCE CD CREEPAGE DISTANCE Sufficient creepage and clearance distances between parts of opposite polarity provided before mains fuses After mains fuses distances verified by short circuit See Table 13 2 for details TRF No IEC60601_1G SI Page 153 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 8 9 3 2 Table Thermal cycling tests on one sample of insulating compound forming N A solid insulation between conductive parts Dielectric strength test a Eachiartcuratonand Peruse ea aa No times 1 6 except for 48 h only Breakdown Yes No 68hatT1 2 C C j 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C C 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C C 1hat25 C 2 C i 2h
110. OCEDURES See Appended RM Results assuring each RISK CONTROL measure reduces Table 14 6 2 identified RISK S satisfactorily provided in addition to PEMS requirements in Clause 6 1 of ISO TAIT T rnae aA eRe A CAAA RAA A documented requirement specification for See Appended RM Results PEMS and each of its subsystems e g for a Table 14 7 PEss which includes ESSENTIAL PERFORMANCE and RISK CONTROL measures implemented by that system or SUDSYStEM ceeeeeeeeeeeeeeeeeeeees An architecture satisfying the requirement is See Appended RM Results N A specified for PEMS and each of subsystems Table 14 8 The architecture specification makes use of N A considers the specified items to reduce RISK to an acceptable level where appropriate a COMPONENTS WITH HIGH INTEGRITY N A N A N A N A N A CHARACTERISTICS e partitioning of functionality f defensive design potentially limiting hazardous effects by restricting available output power or by introducing means to limit travel of actuators h failure modes of components and their effects i common cause failures j systematic failures k test interval duration and diagnostic coverage 1 maintainability m protection from reasonably foreseeable misuse g allocation of RISK CONTROL measures to subsystems and components of PEMS n NETWORK DATA COUPLING specification when applicable Design is broken up into subsystems each See Appended RM Result
111. RATOR is negligible in NORMAL USE and the OPERATOR is appropriately instructed accessible contacts of connectors eo OONA contacts of fuseholders accessible during No fuseholders provided replacement of fuse P Primary fuses are soldered to the PCB contacts of lampholders accessible after removal of lamp parts inside an ACCESS COVER that can be opened without a TOOL or where a TOOL is needed but the instructions for use instruct an OPERATOR other than SERVICE PERSONNEL to open the relevant ACCESS COVER TRF No IEC60601_1G SI Page 47 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Voltage to earth or to other ACCESSIBLE PARTS See appended Table 8 4 2 did not exceed 42 4 V peak a c or 60 V d c for above parts in NORMAL or single fault condition VAC Or dE aioa aieia R Limit of 60 V d c applied with no more than See appended Table 8 4 2 10 peak to peak ripple and when ripple larger than specified value 42 4 V peak limit applied V d C ccesececessseeeeeeseeeeeeseeeeeenseeeeeneseeeees Energy did not exceed 240 VA for longer than See appended Table 8 4 2 60 s or stored energy available did not exceed 20 J at a potential up to 2 V VA or J eee x LEAKAGE CURRENT limits referred to in 8 4 2 b See appended Table 8 4 2 applied when voltages higher than limits in 8 4 2 c were present IMA cccssseeeessseeeeeeeeeees d Voltage and energy li
112. RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE 3 End product consideration The risk management requirements of the standard were not addressed a Parts of ME EQUIPMENT subject to mechanical No such parts provided wear electrical environmental degradation or ageing resulting in unacceptable RISK when unchecked for a long period are accessible for inspection replacement and maintenance Inspection servicing replacement and adjustment of parts of ME EQUIPMENT can easily be done without damage to or interference with adjacent parts or wiring 15 3 Mechanical strength 15 3 1 Mold stress relief push impact drop and See below rough handling tests did not result in unacceptable RISK and ME EQUIPMENT displayed adequate mechanical strength 15 3 2 Push test conducted by subjecting external See Appended Table 15 3 parts of ENCLOSURE to a steady force of 250 N and RM Results Table 15 3 2 10 N for 5 s applied to a circular 30mm plane surface except bottom of ENCLOSURE of an ME The risk management EQUIPMENT gt 18 kg using a Suitable test tool requirements of the standard were not addressed No damage resulting in an unacceptable RISK No damage of the enclosure sustained as determined by examination of no cracks RISK MANAGEMENT FILE EUT is provided with enclosure with adequate strength and rigidity Test performed on desk top version TRF No IEC60601_1G S
113. Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information TRF No IEC60601_1G SLE Page 171 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 9 4 3 1 TABLE Instability from unwanted lateral movement including sliding in N A transport position ME EQUIPMENT Test Condition transport position Remarks Preparation working load locking device s caster position Supplementary information 9 4 3 2 TABLE Instability from unwanted lateral movement including sliding N A excluding transport position ME EQUIPMENT Test Condition working load locking Remarks Preparation device s caster position force force location force direction Supplementary information 9 4 4 TABLE Grips and other handling devices N A Clause and Name of Test Test Condition Remarks Supplementary information No grips or other handling devices 9 5 1 RM RESULTS TABLE Protective means N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 6 1 RM RESULTS TABLE Acoustic energy General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971
114. TIVELY EARTHED parts of ENCLOSURE Allowable Values TRF No IEC60601_1G SLE Page 56 of 279 IEC 60601 1 a Allowable values in 8 7 3 b c and d measured based on and are relative to currents in Fig 12 a or by a device measuring frequency contents of currents as in Fig 12 b b Allowable values of PATIENT LEAKAGE and AUXILIARY CURRENTS are according to Tables 3 amp 4 and values of a c are relative to currents having a frequency not less than 0 1Hz c TOUCH CURRENT did not exceed 100 pA in NORMAL CONDITION and 500 pA in SINGLE FAULT CONDITION lyno Isp eceeteeeeeeeeeeeeeeseeeeeseeeeeeeeeeeenes d EARTH LEAKAGE CURRENT did not exceed 5 mA in NORMAL CONDITION and 10 mA in SINGLE FAULT CONDITION lenc leSrc seseseeeeeeeeeeeeeeeeeeseeeenseeeeeeees Higher values of EARTH LEAKAGE CURRENT permitted for PERMANENTLY INSTALLED ME EQUIPMENT connected to a supply circuit supplying only this ME EQUIPMENT according to local regulations or IEC 60364 7 710 e LEAKAGE CURRENTS regardless of waveform and frequency did not exceed 10 mAr m s in NORMAL or in SINGLE FAULT CONDITION measured with a non frequency weighted device LEAKAGE and PATIENT AUXILIARY CURRENTS measurements Insulation relied on as MEANS OF PROTECTION including REINFORCED INSULATION and insulation between parts of opposite polarity of MAINS PART On SUPPLY MAINS side of mains fuse or OVER CURRENT RELEASE Insulation exe
115. Test Report issued under the responsibility of E D_i _ p IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Report Reference No 22 17223 0330 12 Date Of ISSUE i ciiicciccircinccncennt 2012 09 25 4000 eee ceetedee cece cece reecdee cecececcveree decree Total number of pages 6 279 PAGES enna teat teeta eee ne aeee ener ee ennnen nnna CB Testing Laboratory SIQ Slovenian Institute of Quality and Metrology Testing Laboratory is accredited by Slovenian Accreditation Reg No LP 009 seteetteeeeeeeeeeesetttttteeeeeeeeeet Tr a ka cesta 2 1000 Ljubljana Slovenia GlobTek Inc 186 Veterans Drive Northvale NJ 07647 USA Test specification Standard IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 Test procedure CB Scheme Non standard test N A Test Report Form No 22 1EC60601_1G Test Report Form Originator Underwriters Laboratories Inc Master TRF 0 cceeeeseeeeeees Dated 2010 11 Copyright 2010 IEC System for Conformity Testing and Certification of Electrical Equipment IECEE Geneva Switzerland All rights reserved This publication may be reproduced in whole or in part for non commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material IECEE takes no responsibility for and will not assume
116. V F2 T1A 250V F1 T1A 250V E F2 T1A 250V PROTECTIVE EARTH TERMINAL marked with symbol Correct symbol provided on 6 of Table D 1 IEC 60417 5019 DB 2002 10 PCB near PE terminal except for the PROTECTIVE EARTH TERMINAL in an APPLIANCE INLET according to IEC 60320 1 Relevant tonmodels with protective earth Markings on or adjacent to PROTECTIVE EARTH Not provided on such parts TERMINALS not applied to parts requiring removal to make the connection and remained visible after connection made Symbol 7 of Table D 1 IEC 60417 5017 DB No functional earth terminal N A 2002 10 marked on FUNCTIONAL EARTH TERMINALS provided Terminals for supply conductors marked See Appended RM Results N A adjacent to terminals except when no HAZARD Table 7 3 7 would result when interchanging connections Terminal markings included in ACCOMPANYING DOCUMENTS when ME EQUIPMENT too small to accommodate markings Terminals exclusively for neutral supply Not permanently connected conductor in PERMANENTLY INSTALLED ME equipment EQUIPMENT marked with Code 1 of Table D 3 Code in IEC 60445 Marking for connection to a 3 phase supply if necessary complies with IEC 60445 TRF No IEC60601_1G SI Page 37 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Markings on or adjacent to electrical connection points not applied to parts requiring removal to make connection and remained visible after connection
117. V 2 or better based on IEC 60695 11 10 as decided Py examination of materials data ccccseeeeee PCB is rated UL94 V 1 minimum If no FV Certification FV tests based on IEC 60695 11 10 conducted on 3 samples of complete parts or sections of it including area with min thickness ventilation openings b Fire ENCLOSURE met following TRF No IEC60601_1G SIS Page 92 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark 1 No openings at bottom or as specified in Fig 39 constructed with baffles as in Fig 38 or made of perforated metal as in Table 25 or a metal screen with a mesh lt 2 x 2 mm centre to centre and wire diameter of at least 0 45 mm 2 No openings on the sides within the area included within the inclined line C in Fig 39 3 ENCLOSURE baffles and flame barriers have adequate rigidity and made of appropriate metal or of non metallic materials except constructions based on Table 25 and a mesh FV 2 or better for TRANSPORTABLE ME EQUIPMENT FV 1 or better for fixed EQUIPMENT or STATIONARY EQUIPMENT per IEC 60695 11 10 determined by ENCLOSURE examination or flammability classification based on 11 3a EUT is provided with plastic enclosure without openings Not relevant for open frame and PCB mounted version EUT is provided with plastic enclosure without openings Not relevant for open frame and PCB mounted version See appended Table 8 10
118. X2 or X1 FOWX2 UL E147776 TRF No IEC60601_1G SLE Page 156 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Shantou High MPX Min 250 Vac IEC EN VDE 40034679 Developmen S etn UL E208107 Zone Songtian Min X2 or X1 Enterprise Co Itd Cheng Tung CTX Min 250 Vac IEC EN VDE 40022642 Industrial Max 0 22 uF 60384 14 Min X2 or X1 FOWX2 UL E193049 Tenta Electric MEX Min 250 Vac IEC EN VDE 119119 or Co Max 0 22 uF 60384 14 Min X2 or X1 FOWX2 UL E222911 Appliance TECX Unions SO 222 250 Vac 2 5A IEC EN VDE 40020337 inlet Technology i 60320 1 Corp 2 ping for models AXUT2 UL E220004 y C8 without protective earth for GTM 21089 models only Shenzhen CDJ 8 250 Vac 2 5A IEC EN VDE 40025531 Delikang 60320 1 Elecr nics ia AXUT2 UL E217394 Technology Co C8 Ltd Rong Feng RF 180 250 Vac 2 5A IEC EN VDE 40030168 Industrial Co 60320 1 Era TS AXUT2 UL E102641 Rich Bay R 201A 250 Vac 2 5 A IEC EN VDE 40030384 Company Ltd 2 pi 60320 1 pins C8 AXUT2 UL E184638 Zhejiang LECI DB 8 250 Vac 2 5 A IEC EN VDE 40032028 Electronics Co 60320 1 ee ee AXUT2 E30222 C8 AXUT2 UL E302229 Sun Fair Electric S 01 250 Vac 2 5 A IEC EN VDE 40034449 Wire amp Cable 2 pins 60320 1 A Oe ae i AXUT2 UL E226643 TRF No IEC60601_1G SLE Page 157 of 279 IEC 60601 1 Report No T223 0330 12
119. a IN NORMAL CONDITION Pa eeceseseereeeeeeeeees ignition even when air or inert gas could escape through openings in ENCLOSURE necessary for normal operation of ME EQUIPMENT or its parts ME EQUIPMENT could be energized only after the required minimum overpressure was present long enough to ventilate the ENCLOSURE so that the displaced volume of air or inert gas was at least five times the volume of ENCLOSURE ME EQUIPMENT energized at will or repeatedly when overpressure was continuously present c Ignition sources de energized automatically by means used where G 4 does not apply or complied with G 5 when during operation overpressure dropped below 50 Pa Pa d External surface of ENCLOSURE in which internal overpressure was maintained did not exceed 150 C in 25 C ambient under NORMAL USE and CONDITION C ceceeseeeeeeeeeeeeeeeeeenseeeees ENCLOSURES with restricted breathing ME EQUIPMENT its parts and components enclosed in an ENCLOSURE with restricted breathing complied with the following E Overpressure maintained at the site of potential TRF No IEC60601_1G SI Page 123 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark a A FLAMMABLE AESTHETIC MIXTURE WITH AIR did not form inside ENCLOSURE with restricted breathing when it was surrounded by a FLAMMABLE AESTHETIC MIXTURE WITH AIR of a high concentration for at least 30 min without any pressure differe
120. able for connection to a Power supply unit is suitable SUPPLY MAINS specified to be connected to a for connection to supply separate power supply can be powered by an mains INTERNAL ELECTRICAL POWER SOURCE or a combination of the three c ccseseeeeeeeee 4 10 2 Maximum rated voltage for ME EQUIPMENT Not hand held equipment N A intended to be connected to SUPPLY MAINS is 250 V for HAND HELD ME EQUIPMENT V ce2eeeee 250 V d c or single phase a c or 500 V Rated input voltage P polyphase a c for ME EQUIPMENT and ME SYSTEMS with a RATED input lt 4 KVA V cesssesssssssssssssssseeeee p AO aU VAG 500 V for all other ME EQUIPMENT and ME N A SYSTEMS 4 11 Power input Steady state measured input of ME EQUIPMENT or See appended Table 4 11 ME SYSTEM at RATED voltage and at operating settings indicated in instructions for use did not exceed marked rating by more than 10 Measurements on ME EQUIPMENT or a ME See appended Table 4 11 P SYSTEM marked with one or more RATED voltage ranges made at both upper and lower limits of the rahg eaaa e AEAEE EE Measurements made at a voltage equal tothe N A mean value of the range when each marking of RATED input was related to the mean value of relevant voltage range Power input expressed in volt amperes See appended Table 4 11 N A measured with a volt ampere meter or calculated as the product of steady stat
121. against a hardwood vertical obstacle higher than EQUIPMENT contact point s No damage resulting in an unacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE rigidity and strength stresses by molding or forming operations will not result in an unacceptable RISK Not relevant for open frame and PCB mounted power supply unit no external enclosure provided Mold stress relief test conducted by placing Test was performed at 96 C one sample of complete ME EQUIPMENT ambient temperature ENCLOSURE or a portion of larger ENCLOSURE for 7 hours in a circulating air oven at 10 C over the max temperature measured on ENCLOSURE in 11 1 3 but no less than 70 C ccccseeeeeeees 3 Maximum temperature rise measured on the enclosure top near transformer during normal operation 85 5 C at 40 C ambient temperature No damage of the enclosure No damage of the enclosure after mold stress relief test INTENDED USE EXPECTED SERVICE LIFE and conditions for transport and storage were taken into consideration for selection and treatment of materials used in construction of ME EQUIPMENT Based on review of EQUIPMENT ACCOMPANYING DOCUMENTS specifications and processing of materials and MANUFACTURER S relevant tests or calculations corrosion ageing mechanical wear degradation of biological materials due to bacteria plants animals and the like will not result in an unacceptable RISK
122. aking contact with parts at MAINS VOLTAGE by insulation with a CREEPAGE DISTANCE of at least 1 0 mm a 1500 V dielectric strength and complying with 8 8 4 1 TRF No IEC60601_1G SIS Page 52 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark required test finger did not make electrical See Appended RM Results contact with conductive part when applied Table 8 5 2 3 against access openings with a force of 10 N except when RISK MANAGEMENT PROCESS indicated no unacceptable RISK existed from contact with objects other than a mains socket ora flat Surfaces iiaae aeaa deaa MAXIMUM MAINS VOLTAGE determined to be the 240 Vac highest RATED supply voltage for single phase or d c SUPPLY MAINS powered ME EQUIPMENT as well as INTERNALLY POWERED ME EQUIPMENT with a means of connection to a SUPPLY MAINS V When less than 100 V MAXIMUM MAINS VOLTAGE N A was 250 V MAXIMUM MAINS VOLTAGE was the highest RATED Single phase equipment phase to neutral supply voltage for poly phase ME EQUIPMENT V 2 2seeceeeeeeeeeeeeneeeeeeeeseeseeneeees Supply voltage 100 240 Vac for other INTERNALLY POWERED ME EQUIPMENT Not internally powered maximum mains voltage was 250 V equipment Mains operated equipment Input supply voltage to ME EQUIPMENT was Input voltage 240 Vac RATED voltage or voltage within RATED range resulting in highest measured value V WORKING
123. ance coupler is considered as disconnecting device Open frame and PCB mounted power supply unit end product consideration Limits specified in Clause 8 4 not exceeded for ACCESSIBLE PARTS and APPLIED PARTS in NORMAL or SINGLE FAULT CONDITIONS NORMAL CONDITION considered as simultaneous occurrence of situations identified in 8 1a SINGLE FAULT CONDITION considered to include N A the occurrences as specified in Clause 8 1b Tables 8 1b 1 2 3 ACCESSIBLEPARTSdetermined according t059 Lease currents measured according t087 a separate power source other than SUPPLY MAINS separate power source considered as part of ME EQUIPMENT or combination considered as an ME SYSTEM When a generic separate power supply specified specification in ACCOMPANYING DOCUMENTS examined ESSENTIAL PERFORMANCE developed when a Table 8 2 2 connection with wrong polarity made for ME SA EQUIPMENT from an external d c source EUT Is intended for connection to the mains Protective devices that can be reset by anyone without a TOOL restore correct operation on a APPLIED PART specified in ACCOMPANYING No applied parts provided DOCUMENTS as Suitable for DIRECT CARDIAC APPLICATION S TYPE CF PUT IS power Supply unit TRF No IEC60601_1G SI gt Page 46 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark b An APPLIED PART provided with a PATIENT N A CONNECTION intended to deliver electr
124. and when necessary refilled starting from position Of NORMAL USE 008 TRF No IEC60601_1G See Appended Table 11 6 1 See Appended RM Results Table 11 6 2 and Table 11 6 N A N A SI Page 93 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ME EQUIPMENT met dielectric strength and See appended Table 8 7and LEAKAGE CURRENT tests and uninsulated 8 8 3 electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were NOU WO AE A E ETT 11 6 3 Spillage on ME EQUIPMENT and ME SYSTEM No liquid use N A ME EQUIPMENT and ME SYSTEMS handling liquids See Appended RM Results in NORMAL USE positioned as in 5 4 a and liquid Table 11 6 3 and Table 11 6 with composition volume duration of spill point of contact and test conditions based on RISK MANAGEMENT PROCESS poured steadily on a point on top Of ME EQUIPMENT cccceseesseeeee ME EQUIPMENT met dielectric strength and See appended Tables 8 7 LEAKAGE CURRENT tests and uninsulated 8 8 3 electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were NOt Wet e A E ited T H Leakage See 13 2 6 No liquids used during normal use of the equipment Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS ME EQUIPMENT with IP Code placed in least See Appended RM Results favourable position of NORMAL USE and Table 11 6 5 and Table 11 6
125. andles knobs levers and the like regarded as ACCESSIBLE PARTS cescecsseeseeeseeeseeeseeeseeeseesseeesees Conductive parts of actuating mechanisms See Appended RM Results not considered ACCESSIBLE PARTS when Table 5 9 2 3 removal of handles knobs etc required use of a TOOL and inspection of RISK MANAGEMENT FILE indicated the relevant part is unlikely to detach unintentionally during EXPECTED SERVICE LIFE of ME EQUIPMENT CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS CLASS ME EQUIPMENT externally powered Power supply unit with protective earth End product consideration for open frame and PCB mounted version CLASS II ME EQUIPMENT externally powered Power supply unit without protective earth End product consideration for open frame and PCB mounted version INTERNALLY POWERED ME EQUIPMENT EUT is not internally powered equipment EQUIPMENT with means of connection to a SUPPLY MAINS complied with CLASS or CLASS II ME EQUIPMENT requirements when so connected and when not connected to SUPPLY MAINS with INTERNALLY POWERED ME EQUIPMENT requirements lt OOO Tecra perenuanonenoor wrons ENCLOSURES classified according to degree of See RM Results Table 11 6 5 protection against ingress of water and particulate matter IPN4N2 as per IEC 60529 No protection against ingress of water provided therefore no marking required Ordinary equipment TRF No IEC60601_1G SIS Page 30 of
126. aragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 2 3 2 RM RESULTS TABLE Over travel N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 2 4 RM RESULTS TABLE Emergency stopping devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 6 6 TRF No IEC60601_1G SLE Page 169 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 9 2 4 RM RESULTS TABLE Emergency stopping devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Supplementary information 9 2 5 RM RESULTS TABLE Release of patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 3 RM RESULTS TABLE Hazards associated with surfaces corners and edges P Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5
127. art of the investigation i if molded on type hospital grade mains plug complying with CSA C22 2 No 21 j hospital grade disassembly attachment plug type complying with CSA C22 2 No 42 or k Class Il equipment having fuses on the line side sides and neutral and may use a non polarized attachment plug or a polarized attachment plug CSA configuration type 1 15P shall be required and shall meet all applicable requirements in CSA C22 2 No 21 and CSA C22 2 No 42 Where a polarized attachment plug is used the POWER SUPPLY CORD shall be connected to the wiring of the EQUIPMENT on the ungrounded side of the line when any of the following devices are used in the primary circuit 1 the centre contact of an Edison base lamp holder 2 a single pole switch 3 an automatic control with a marked off position 4 a solitary fuse fuse holder or 5 any other single pole over current protective device b Detachable POWER SUPPLY CORD for non Power supply cord was not PERMANENTLY INSTALLED EQUIPMENT part of the investigation cord connected equipment shall be of a type that i can be shown to be unlikely to become detached accidentally unless it can be shown that detachment will not constitute a safety HAZARD to a PATIENT or OPERATOR j can be shown that the impedance of the earth ground circuit contacts will not constitute a safety HAZARD to a PATIENT or OPERATOR and k has a terminal configuration or othe
128. ase material towards any person e With discharge opening located and directed as to not to deposit material on parts that could result in an unacceptable RISK f Adequate discharge capacity provided to ensure that pressure will not exceed MAXIMUM PERMISSIBLE WORKING PRESSURE of system it is connected to by more than 10 when failure occurs in control of supply pressure g No shut off valve provided between a N A pressure relief device and parts it is to protect h Min number of cycles of operation 100 000 except for one time use devices bursting HAZARDS associated with support systems ME EQUIPMENT parts designed to support loads See appended Table 8 10 and or provide actuating forces when a Appended RM Results Table mechanical fault could constitute an 9 8 1 Unsere ptabla RISK EUT is not intended to support loads Construction of support suspension or actuation system complied with Table 21 and TOTAL LOAD possibility of incorrect attachment that could result in an unacceptable RISK RISK ANALYSIS of support systems included HAZARDS from static dynamic vibration impact and pressure loading foundation and other movements temperature environmental manufacture and service conditions RISK ANALYSIS included effects of failures such as excessive deflection plastic deformation ductile brittle fracture fatigue fracture instability buckling stress assisted corrosion cracking wear material creep a
129. at least the voltage in Tables 6 and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY INSULATION V ssesesesesseresseeseaseeeeaeanseeeeesaeasssensees f 3000 V for REINFORCED INSULATION V 004 Oven temperature based on Table L 2 C Foo e Mandrel diameter and tension applied as in clause L 3 2 Mpa N mm e E nein Dielectric strength test conducted at room N A temperature after removal from the oven Retention of electric strength after bending Five samples prepared as in L 3 2 subjected to N A dielectric strength and bending tests TRF No IEC60601_1G tod i m Tension applied to wire during winding on E 3 sw SI Page 127 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Test voltage was at least the voltage in Tables N A 6 and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY N A INSULATION M cenieni 3000 V for REINFORCED INSULATION V aAa Test voltage applied between the shot and N A conductor Mandrel diameter and tension applied as in N A L 3 2 Mpa NIMM cccsssecsessesessessesessesseeeeseens Tests during manufacture N A Production line dielectric strength tests See attached conducted by the manufacture according to manufacturer s routine L 4 2 and 1 4 3 oes testing verification Test voltage for routine testing 100 testing is at least the voltage in Tables 6 and
130. at the point of maximum moment to working surfaces offering an foothold or sitting surface of a min 20 x 20 cm area and at a height lt 1 m from the floor Castors and wheels N A Means used for transportation of MOBILE ME No castors and wheels N A EQUIPMENT e g castors or wheels did not provided result in an unacceptable RISK when MOBILE ME EQUIPMENT moved or parked in NORMAL USE Not mobile equipment Force required to move MOBILE ME EQUIPMENT See Appended Table 9 4 2 4 2 along a hard and flat horizontal surface did not exceed 200 N applied at a height of 1 m above floor or highest point on ME EQUIPMENT when lt 1 m high except when instructions indicated more than one person needed N MOBILE ME EQUIPMENT exceeding 45 kg See Appended Table 9 4 2 4 3 configured with a SAFE WORKING LOAD moved 10 times in forward direction over a solid vertical plane obstruction with wheels impacting the obstruction at a speed of 0 4 m s 0 1 m s for manual or with max speed for motor driven MOBILE ME EQUIPMENT cese0100 f ME EQUIPMENT went up the obstruction without See Appended RM Results overbalancing or any other unacceptable RISK Table 9 4 2 3 as determined by examination of RISK MANAGEMENT FILE ME EQUIPMENT and its parts There was no reduction of CREEPAGE and CLEARANCES below 8 9 no access to parts exceeding limits in 8 4 and no access to moving parts capable of causing HARM and
131. at0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C C 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C Supplementary information T1 10 C above the maximum temperature of relevant part determined per 11 1 1 or 85 C the higher of the two 10 C not added to T1 when temperature measured by an embedded thermocouple Used gradual transition from one temperature to another TRF No IEC60601_1G SI gt Page 154 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 8 9 3 4 Table Thermal cycling tests on one sample of cemented joint see 8 9 3 3 N A l Dielectric strength test e a e ea car No times 1 6 except for 48 h only Breakdown Yes No 68hatT1 2 C C 1hat 25 C 42 C 2hat0 C 42 C 1 or more h at 25 C 2 C 68hatT1 2 C C 1hat 25 C 42 C i 2hat0 C 42 C 1 or more h at 25 C 2 C 68hatT1 2 C C 1hat 25 C 42 C j 2hat0 C 42 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C P 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C Supplementary information T1 10 C above the maximum temperature of relevant part determined per 11 1 1 or 85 C the higher of the two 10 C not added to T1 when temperature measured by an embedded thermocouple Used gradual transition from one temperature to another
132. ating the protective device in a This portion concluded at specified time or when a second protective device opened It is not possible to state compliance using a 95 coverage probability for the expanded uncertainty Expanded uncertainty U 3 C coverage factor kp 2 confidence level 95 15 5 2 TABLE Transformer dielectric strength after humidity preconditioning of 5 7 N A Transformer Test voltage applied between Test Test Breakdown Deterioration Model Type Part voltage frequency Yes No No V Hz Primary amp secondary windings Primary winding amp frame Secondary winding amp frame Supplementary information Tests conducted under the conditions of 11 1 in ME EQUIPMENT or under simulated conditions on the bench See Clause 15 5 2 for test parameters amp other details Switch mode transformer incorporated within the power supply unit Refer to Clause 8 8 3 16 1 RM RESULTS TABLE General requirements for ME Systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information 16 6 1 TABLE LEAKAGE CURRENTS in ME SYSTEM _ TOUCH CURRENT MEASUREMENTS N A Specific area where TOUCH Allowable Measured Allowable TOUCH CURRENT Measured TOUCH CURRENT measured i e from TOUCH CURRENT TOUCH CURRENT in event of interruption of CURRENT in event of or
133. between parts of ME SYSTEM in NORMAL in NORMAL PROTECTIVE EARTH interruption of within PATIENT ENVIRONMENT CONDITION pA CONDITION pA CONDUCTOR A PROTECTIVE EARTH CONDUCTOR uA TRF No IEC60601_1G SIS Page 210 of 279 Report No T223 0330 12 100 500 100 500 100 500 100 500 100 500 Supplementary information 16 9 1 RM RESULTS TABLE Connection terminals and connectors N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 17 RM RESULTS TABLE Electromagnetic compatibility of ME equipment and N A ME systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information SP TABLE Additional or special tests conducted P Clause and Name of Test Test type and condition Observed results TRF No IEC60601_1G SLE Page 211 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict Supplementary information See Tables below TABLE evaluation of voltage limiting components in SELV circuits Component measured between max voltage V Voltage Limiting normal operation Components Input voltage 240 Vac 50 Hz
134. by 25 mm min 0 8 mm thick Secured to PCB by soldering Rear edge on the output side of the power supply covered with insulation tape 1 layer on both top and bottom side min 8 0 mm Insulation L shaped IEC EN Accepted foll FORMEX GK 18 or PT230N T Sopot Top dimensions 28 mm by 32 mm min 0 40 mm thick Side dimensions 19 mm by 18 mm min 0 40 mm thick Provided between heat sink and transformer top side and between insulator silpad around D8 and transformer side Insulator Various Various Around D8 IEC EN Accepted sipag Min 0 4mm thick 60601 1 Covered with 3 layer of insulation tape Insulation Formex Formex GK 18 63 mm by 40 mm IEC EC Accepted foil provided min 0 40 mm thick 60601 1 between PCB and metal UL 94 V0 QMFZ2 UL E121855 primary shield ITW Electronics GK 17 63 mm by 40 mm IEC EC Accepted Components min 0 40 mm thick 60601 1 UL 94 V0 QMFZ2 UL E256266 TRF No IEC60601_1G SIS Report No T223 0330 12 Page 162 of 279 IEC 60601 1 Requirement Test Result Remark Mianyang PC 870 63 mm by 40 mm IEC EC Accepted Longhua Film min 0 40 mm thick 60601 1 Boa tie UL 94 vo QMFZ2 UL E254551 SABIC FR60 GG 63 mm by 40 mm IEC EC Accepted de ha FR63 GG min 0 40 mm thick 60601 1 FR65 GG UL 94 V0 QMFZ2 UL E121562 FR7 GG FR700 GG Insulation 3M Company Mylar Min 0 06 mm thick IEC EN Accepted tape Min 130 C 60601 1 OANZ2 UL E17385 Symbio
135. by material UL94 V 1 minimum All internal components are mounted on the PCB made by material UL94 V 1 minimum Therefore power supply enclosure shall be treated as fire enclosure Not relevant for open frame and PCB mounted version Supply circuit was unable to supply 15 W See appended Table 13 1 2 one minute after 15 W drawn from supply circuit or Parts and components completely contained within a fire ENCLOSURE complying with 11 3 as verified by review of design documentation ree TRF No IEC60601_1G SI Page 97 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark After tests of this Clause settings of THERMAL N A CUT OUTS and OVER CURRENT RELEASES did not change sufficiently to affect their safety function 13 1 3 limits for LEAKAGE CURRENT in SINGLE FAULT See appended Table 8 7 CONDITION based on 8 7 3 did not exceed voltage limits for ACCESSIBLE PARTS including See appended Table 8 7 APPLIED PARTS in 8 4 2 did not exceed Output voltage of the power supply unit 13 1 4 ME EQUIPMENT complied with the requirements of 9 1 to 9 8 for specific MECHANICAL HAZARDS m2 smoueranrconomons 13 2 1 During application of SINGLE FAULT CONDITIONS in See appended Table 13 2 13 2 2 13 2 13 inclusive NORMAL CONDITIONS in 8 1 a applied in least favourable combination 13 2 2 ME EQUIPMENT complied with 13 2 2 13 2 12 _ See appende
136. ce for single activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 5 RM RESULTS TABLE Systems without mechanical protective devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 10 1 1 TABLE Measurement of X radiation N A TRF No IEC60601_1G SI Page 177 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Maximum allowable radiation pA kg uSv h mR h 36 5 uSv h 0 5 mR h Surface area under test Measured Radiation Remarks Surface no Description pA kg uSv h mR h 1 2 3 Al 5 6 7 8 9 10 Supplementary information Measurements made at a distance of 5 cm from any surface to which OPERATOR other than SERVICE PERSONNEL can gain access without a TOOL is deliberately provided with means of access or is instructed to enter regardless of whether or not a TOOL is needed to gain access sS s 10 1 2 RM RESULTS TABLE ME equipment intended to produce diagnostic or N A therapeutic X radiation Clause of Document Ref in RMF Resul
137. cidentally actuated to result in unacceptable RISK except when ergonomic considerations for a PATIENT with special needs require otherwise Risk due to over travel past range limits of See appended Table 8 10 and ME EQUIPMENT parts reduced to an acceptable Appended RM Results Table level and stops or other means with 9 2 3 2 mechanical strength to withstand intended loading in NORMAL USE and foreseeable misuse provided limiting measure in NORMAL and SINGLE FAULT CONDITION Emergency stopping devices N A TRF No IEC60601_1G Speed of movement s positioning parts of ME See Appended RM Results EQUIPMENT or PATIENT when contact with ME Table 9 2 2 6 EQUIPMENT could result in a HAZARDOUS SITUATION limited to allow OPERATOR control of positioning without resulting in an SI gt Page 74 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Where necessary to have one or more See Appended RM Results emergency stopping device s emergency Table 9 2 4 stopping device complied with all the following except for actuating switch EE of interrupting all pOWer ssssssssssssnsessnnnnnnenennnnnne a Emergency stopping device reduced RISK to an acceptable level b Proximity and response of OPERATOR to actuate emergency stopping device could be relied upon to prevent HARM c Emergency stopping device actuator was N A readily accessible to OPERATOR d Emergency stopping device s are not part o
138. ction No applied parts provided and sterilization methods and applicable parameters that can be tolerated by ME EQUIPMENT parts or ACCESSORIES specified Components ACCESSORIES or ME EQUIPMENT marked for single use except when required by MANUFACTURER to be cleaned disinfected or sterilized prior to use Instructions provided on preventive inspection calibration maintenance and its frequency Information provided for safe performance of routine maintenance necessary to ensure continued safe use of ME EQUIPMENT Parts requiring preventive inspection and EUT is maintence free maintenance to be performed by SERVICE PERSONNEL identified including periods of application Instructions provided to ensure adequate No rechargeable batteries maintenance of ME EQUIPMENT containing incorporated rechargeable batteries to be maintained by anyone other than SERVICE PERSONNEL Mains operated equipment Other equipment providing power to ME SYSTEM Mains operated equipment sufficiently described e g part number RATED VOLTAGE max or min power protection class intermittent or continuous service RISKS associated with disposal of waste Provided within safety products residues etc and of ME EQUIPMENT instructions The power and ACCESSORIES at the end of their EXPECTED supply has to be disposed SERVICE LIFE are identified and instructions appropriately Please refer provided on minimizing these RISKS 00 to local
139. d No fire no hazard 2 Short circuit of T1 Pin 2 to Pin 4 No output voltage No Supply voltage 264 Vac Primary fuse opened Model GTM21089 1824 24 Vdc output immediately No high temperature rises observed No fire no hazard TRF No IEC60601_1G SLE Page 195 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark 3 Short circuit of Q3 D to S Output voltage dropped to 0 No Supply voltage 264 Vac Nimmedigtely Model GTM21089 1824 24 Vdc output a opened Unit damaged No high temperature rises observed No fire no hazard 4 Short circuit of D3 Output voltage dropped to 0 No Supply voltage 264 Vac Wiramediately Model GTM21089 1824 24 Vdc output AA opened No high temperature rises observed No fire no hazard 5 Short circuit of U1 shorted primary pins Output voltage dropped to 0 No Supply voltage 264 Vac V immediately Model GTM21089 1824 24 Vdc output e EN nges Rated load After removal of SC unit operated normally No fire no hazard 6 Short circuit of U1 shorted primary pins Output voltage slowly No Supply voltage 264 Vac Model GTM21089 1824 24 Vdc output Rated load dropped from 24 Vdc to 10 Vdc No high temperature rises observed After removal of SC unit operated normally No fire no hazard TRF No IEC60601_1G SIS Page 196 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Res
140. d stating Transport only under conditions described in instructions for use or marked on ME EQUIPMENT with an indication of RESIDUAL RISK if ME EQUIPMENT or its parts overbalances when overbalance occurred during 10 inclined plane test Instability from horizontal and vertical forces a ME EQUIPMENT with a mass of 25 kg or more Mass of equipment less than other than FIXED ME EQUIPMENT for use on floor 25 kg did not overbalance due to pushing or resting TRF No IEC60601_1G SIS Page 76 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Surfaces of ME EQUIPMENT where a RISK of overbalancing exists from pushing leaning resting etc permanently marked with a CLEARLY LEGIBLE warning of the RISK e g safety sign 5 of Table D 2 safety sign ISO 7010 P017 ME EQUIPMENT did not overbalance when placed on a horizontal plane and a force of 25 of its weight but not more than 220 N applied in different directions except a direction with an upward component b ME EQUIPMENT other than FIXED ME EQUIPMENT for use on the floor or on a table did not overbalance due to sitting or stepping except when a legible warning of this RISK provided on ME EQUIPMENT e g safety signs 6 and 7 of Table D 2 safety signs ISO 7010 P018 or ISO 7010 P019 as appropriate ME EQUIPMENT did not overbalance when See Appended Table 9 4 2 3 placed on a horizontal plane and a constant force of 800 N applied
141. d 3 times from each orientation in NORMAL USE cm Not hand held equipment sample and RISK MANAGEMENT FILE EUT is provided with enclosure with adequate strength and rigidity Test performed on desk top version Each sample of MOBILE ME EQUIPMENT and MOBILE See Appended Table 15 3 part with SAFE WORKING LOAD and in most and RM Results Table 15 3 5 adverse condition in NORMAL USE passed Rough Handling tests 0 0 cccseececesseneeeeeeeeeeeeeseeeeeeseeeeenees EMT Jenotmobile equipment a Ascending step shock test conducted on the sample by pushing it 3 times in its normal direction of travel at 0 4 m s 0 1 m s against an ascending hardwood step obstruction without the sample going over the obstruction No damage resulting in an unacceptable RISK No damage of the enclosure sustained as determined by examination of no cracks TRF No IEC60601_1G Page 106 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict 15 4 b Descending step shock test conducted on the sample by pushing it 3 times in its normal direction of travel at 0 4 m s 0 1 m s in order to fall over a vertical step affixed flat on a rigid base with direction of movement perpendicular to face of the step until full descent achieved c Door frame shock test conducted on the sample by moving it 3 times in its normal direction of travel at 0 4 m s 0 1 m s or for motor driven EQUIPMENT at maximum possible speed
142. d Table 13 2 13 2 12 and RM Results Table 13 2 6 13 2 13 ME EQUIPMENT remained safe after tests of No heating elements or 13 2 13 2 to 13 2 13 4 inclusive and cooling motors provided down to room temperature EUT is intended for continuous operation No markings provided ME EQUIPMENT examined for compliance or appropriate tests such as dielectric strength of motor insulation according to 8 8 3 conducted For insulation of thermoplastic materials relied upon as a MEANS OF PROTECTION see 8 8 the ball pressure test specified in 8 8 4 1 a performed at a temperature 25 C higher than temperature of insulation measured during tests of 13 2 13 2 to 13 2 13 4 inclusive 13 2 13 2 ME EQUIPMENT with heating elements N A a 1 thermostatically controlled ME EQUIPMENT No heating elements N A with heating elements for building in or for provided unattended operation or with a capacitor not protected by a fuse connected in parallel with THERMOSTAT contacts met tests of 13 2 13 2 b amp 13 2 13 2 c a 2 ME EQUIPMENT with heating elements RATED for Non CONTINUOUS OPERATION met tests of 13 2 13 2 b and 13 2 13 2 c a 3 other ME EQUIPMENT with heating elements met test of 13 2 13 2 b When more than one test was applicable to same ME EQUIPMENT tests performed consecutively TRF No IEC60601_1G SI gt Page 98 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Heating period stopped
143. d for more than one APPLIED PART and different APPLIED PARTS with different classifications Safety sign 2 of Table D 2 ISO 7010 W001 placed near relevant outlet when protection against effect of discharge of a cardiac defibrillator is partly in the PATIENT cable TRF No IEC60601_1G SI gt Page 34 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark An explanation indicating protection of ME EQUIPMENT against effects of discharge of a cardiac defibrillator depends on use of proper cables included in instructions for use a ME EQUIPMENT not marked to the contrary No markings provided assumed to be suitable for CONTINUOUS therefore EUT is intended OPERATION for continuous operation DUTY CYCLE for ME EQUIPMENT intended for non EUT is designed for CONTINUOUS OPERATION appropriately marked tor continuous operation provide maximum on and off time Type and full rating of a fuse marked adjacent to No accessible fuses ACCESSIBLE fuse holder provided End product consideration for open frame and PCB mounted power supply unit A safety sign CLEARLY LEGIBLE and visible after EUT not produces INSTALLATION in NORMAL USE applied to a physiological effects prominent location of EQUIPMENT that produce physiological effects capable of causing HARM to PATIENT Or OPERATOR not obvious to OPERATOR Nature of HAZARD and precautions for avoiding See Appended RM Re
144. ds N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 TRF No IEC60601_1G SI Page 167 of 279 Report No T223 0330 12 9 2 2 4 3 RM RESULTS TABLE Movable guards N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 4 6 5 Supplementary information 9 2 2 4 4 RM RESULTS TABLE Protective measures N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 2 2 5 c RM RESULTS TABLE Continuous activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 2 2 6 RM RESULTS TABLE Speed of movement s N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 TRF No IEC60601_1G SIS Page 168 of 279 Report No T223 0330 12 9 2 2 6 RM RESULTS TABLE Speed of movement s N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp p
145. e Powel Inpavexpressen ln current measured as described above and Amperes supply voltage eeeceeeeceeseteeeseeetseteteeseeeeeeeees SEE Copy Of marking plate for details S GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT 5 1 TYPE TESTS determined in consideration of Clause 4 in particular 4 2 TRF No IEC60601_1G SI gt Page 26 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Test not performed when analysis indicated See Appended RM Results condition being tested was adequately Table 5 1 evaluated by other tests or methods Type test performed according to all applicable clauses of standard IEC 60601 1 2005 Results of RISK ANALYSIS used to determine Applicable single faults combination s of simultaneous faults to be performed tested TYPE TESTS conducted on one representative Type test performed on sample under investigation multiple samples multiple samples used simultaneously when validity of results was not significantly affected sesseseeeee Validity et results not significantly affected a Tests conducted within the environmental conditions specified in technical description Temperature C Relative Humidity 0 40 C Up to 90 RH b ME EQUIPMENT shielded from other No other influences influences that might affect the validity of tests c Test conditions modified and results Temperature tests perf
146. e SELV output During single fault conditions output voltage was below SELV limit 12 4 5 2 RM RESULTS TABLE Diagnostic X ray equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 TRF No IEC60601_1G SI gt Page 193 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 12 4 5 2 RM RESULTS TABLE Diagnostic X ray equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 5 Supplementary information EUT is not diagnostic X ray equipment 12 4 5 3 RM RESULTS TABLE Radiotherapy equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 12 4 5 4 RM RESULTS TABLE Other ME equipment producing diagnostic or N A therapeutic radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 12 4 6 RM RESULTS TABLE Diagnostic or therapeutic acoustic pressure N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document
147. e of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information Primary fuses incorporated in both supply leads See enclosed pictures of the unit for details TRF No IEC60601_1G SI gt Page 166 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 9 2 1 RM RESULTS TABLE HAZARDS associated with moving parts General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No moving parts 9 2 2 2 TABLE Measurement of gap a according to Table 20 ISO 13852 1996 9222 of body Allowable adult Measured adult Allowable children yt NA children gap mm gap mm gap mm gap mm Body gt 500 gt 500 Head gt 300 or lt 120 gt 300 or lt 60 Leg gt 180 gt 180 Foot gt 120 or lt 35 gt 120 or lt 25 Toes gt 50 gt 50 Arm gt 120 gt 120 Hand wrist fist gt 100 gt 100 Finger gt 25or lt 8 gt 25o0r lt 4 Supplementary information In general gaps for adults used except when the device is specifically designed for use with children values for children applied 9 2 2 4 3 RM RESULTS TABLE Movable guar
148. e with NEC Addition to agree with NEC The requirement EUT is not permanently ALL FIXED ME EQUIPMENT and installed equipment or fixed PERMANENTLY INSTALLED ME EQUIPMENT ME equipment are CLASS ME EQUIPMENT Deleted the second sentence and note to sub clause 8 7 3 d to read as follows to agree with NFPA 99 which does not permit for allowances larger than the stated values d The allowable values of the EARTH Considered LEAKAGE CURRENT are 5 mA in NORMAL CONDITION and 10 mA in SINGLE FAULT CONDITION MAINS PARTS components and layout Addition to agree with NEC Se considered acceptable when supply connection provided with a length of attached Type S hard service flexible cord or equivalent Installation of connecting cords between No connecting cord between EQUIPMENT parts comply with NEC as equipment parts provided applicable Only output cable provided ae The requirement Permanently connected ME EUT is not permanently EQUIPMENT shall have provision for the connected equipment connection of one of the wiring systems that is in accordance with the NEC Fixed and stationary X ray ME EQUIPMENT supplied from a branch circuit rated at 30 A or less and ME EQUIPMENT not strictly portable but obviously intended to be stationary SIS Page 214 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Cable used as external interconnection N A between units
149. ective earth or potential equalization system or via wheels to an antistatic floor of medical room b Electrical resistance limits of aesthetic tubing mattresses and pads castor tires and other antistatic material complied with ISO 2882 based on measurements according to ISO 1853 ISO 2878 and ISO 23529 ecseeseeeeeeees Corona cannot be produced by components or parts of ME EQUIPMENT operating at more than 2000 V a c or 2400 V d c and not included in ENCLOSURES complying with G 5 4 or G 5 5 ME EQUIPMENT its parts or components do not ignite FLAMMABLE AESTHETIC MIXTURES WITH AIR under NORMAL USE and CONDITIONS based on compliance with G 5 2 to G 5 5 inclusive Alternatively ME EQUIPMENT its parts and components complied with requirements of IEC 60079 0 for pressurized ENCLOSURES IEC 60079 2 for sand filled ENCLOSURES IEC 60079 5 or for oil immersed equipment IEC 60079 6 and with this standard excluding G 5 2 to G 5 5 TRF No IEC60601_1G SI Page 121 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ME EQUIPMENT its parts and components in See appended Tables 11 1 1 contact with gas mixtures in NORMAL USE and 11 1 2 1 11 1 2 2 amp 11 2 2 1 CONDITIONS not producing sparks and not resulting in surface temperatures above 150 C in case of restricted or 200 C in case of unrestricted vertical air circulation measured at 25 C comply with G 5 1 ceee
150. ed b Wiring cord forms or components are not likely to be damaged during assembly or during opening or closing of ACCESS COVERS where such damage could result ina HAZARDOUS SITUATION as Shown by manual tests and RISK MANAGEMENT FILE Guiding rollers of insulated conductors prevent bending of movable insulated conductors around a radius of less than five times the outer diameter of the lead concerned in NORMAL USE a Insulating sleeve that can only be removed See appended Table 8 10 by breaking or cutting or secured at both P e No insulation sleeve used ends is used on internal wiring of when Q atia a b Sheath of a flexible cord not used as a MEANS OF PROTECTION inside ME EQUIPMENT when it is subject to mechanical or thermal stresses beyond its RATED characteristics c Insulated conductors subject to See appended Table 8 10 temperatures gt 70 C in NORMAL USE provided with insulation of heat resistant material when compliance is likely to be impaired due to deterioration of insulation ceeeeeeees No such high temperature rises obtained during normal use of the equipment MAINS PARTS components and layout TRF No IEC60601_1G SIS Page 66 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark a ME EQUIPMENT provided with means of See appended Table 8 10 electrically isolating its circuits from SUPPLY MAINS simultaneously on all poleS 00000 x lt
151. ed where appropriate TRF No IEC60601_1G SI Page 101 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Problem resolution system meets the prescribed criteria depending on type of product it is documented as a part of PEMS DEVELOPMENT LIFE CYCLE it allows reporting of potential or existing problems affecting BASIC SAFETY or ESSENTIAL PERFORMANCE it identifies criteria that must be met for the issue to be closed with software and hardware aspects of PEMS including NETWORK DATA COUPLING components of third party origin legacy subsystems when compiling list of known or foreseeable HAZARDS In addition to the material in ISO 14971 Annex D list of possible sources for HAZARDS associated with PEMS includes specified causes failure of NETWORK DATA COUPLING to provide characteristics necessary for PEMS to achieve its BASIC SAFETY or ESSENTIAL PERFORMANCE undesired feedback physical and data such as unsolicited out of range inconsistent input or input from electromagnetic interference unknown aspects or quality of third party software unknown aspects or quality of third party PESS lack of data security particularly vulnerability to tampering unintended interaction with other programs and viruses TRF No IEC60601_1G SIS Page 102 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Suitably validated tools and PR
152. eded Coating not removed when requirements for impedance and current carrying capacity met Plugs and sockets PROTECTIVE EARTH CONNECTION where connection between SUPPLY MAINS and ME EQUIPMENT or between separate parts of ME EQUIPMENT made via a plug and socket was made before and interrupted after supply connections applied also where interchangeable parts are No interchangeable parts PROTECTIVELY EARTHED Terminal for connection of a POTENTIAL EQUALIZATION CONDUCTOR Terminal is accessible to OPERATOR with ME No potential equalization EQUIPMENT in any position of NORMAL USE conductor provided RISK of accidental disconnection minimized in NORMAL USE Terminal allows conductor to be detached without a TOOL Terminal not used for a PROTECTIVE EARTH CONNECTION E ess Poorly conducting surface coatings on N A conductive elements removed at the point of contact i ne ecm Ew a 4 Ls Eo a TRF No IEC60601_1G SI Page 55 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Terminal marked with symbol 8 of Table D 1 N A i e symbol IEC 60417 5021 Instructions for use contain information on N A function and use of POTENTIAL EQUALIZATION CONDUCTOR together with a reference to requirements of this standard POWER SUPPLY CORD does not incorporate a N A POTENTIAL EQUALIZATION CONDUCTOR 8 6 8 FUNCTIONAL EARTH TERMINAL not used to provide N A a PROTECTIVE
153. eeeeeeeeeees No changes of the markings after durability test b Markings required by 7 2 7 6 remained See appended Tables 7 1 3 CLEARLY LEGIBLE after marking durability test and 8 10 No changes of the markings after durability test At least markings in 7 2 2 7 2 5 7 2 6 not for See attached copy of PERMANENTLY INSTALLED ME EQUIPMENT 7 2 10 Marking Plate and 7 2 13 were applied when size of EQUIPMENT its part an ACCESSORY or ENCLOSURE did not permit application of all required Markings eseeeeceeseeeeeeeseeeenneneeeeeeeenes Remaining markings fully recorded in See above ACCOMPANYING DOCUMENTS cssseeceeeeeeseeeesseeeneeees All required markings are provided on the marking plate TRF No IEC60601_1G Page 31 of 279 IEC 60601 1 Markings applied to individual packaging when impractical to apply to ME EQUIPMENT A material component ACCESSORY or ME EQUIPMENT intended for a single use or its packaging marked Do Not Reuse or with symbol 28 of Table D 1 ISO 7000 1051 DB 2004 01 MANUFACTURER S name or trademark marked on ME EQUIPMENT and detachable components i Misidentification does not present an unacceptable risk MODEL OR TYPE REFERENCE also marked except when misidentification would not present an unacceptable RISK ssssssssessunnnnunnrennnnnnnnennnnnnnne Software forming part of a PEMS identified with a unique identifier such as revision level or
154. ees A pressure vessel withstood a HYDRAULIC TEST See Appended Table 9 7 5 PRESSURE when pressure was gt 50 kPa and product of pressure and volume was more than 200 kPahinis ii cic ceseiececdccvecesecstdenereeveseccetcees Pressure control device regulating pressure in See Appended RM Results ME EQUIPMENT with pressure relief device Table 9 7 6 completed 100 000 cycles of operation under RATED load and prevented pressure from exceeding 90 of setting of pressure relief device in different conditions of NORMAL USE No such devices incorporated Pressure relief device s used where MAXIMUM See Appended RM Results PERMISSIBLE WORKING PRESSURE could otherwise Table 9 7 7 be exceeded met the following as confirmed by MANUFACTURER S data ME EQUIPMENT RISK MANAGEMENT FILE and functional tests a Connected as close as possible to pressure vessel or parts of system it is to protect b Installed to be readily accessible for inspection maintenance and repair c Could be adjusted or rendered inoperative without a TOOL No pressure relief devices 9 7 4 Max pressure in NORMAL and SINGLE FAULT See Appended RM Results CONDITIONS did not exceed MAXIMUM PERMISSIBLE Table 9 7 4 WORKING PRESSURE for EQUIPMENT part except TRF No IEC60601_1G SI Page 81 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark d With discharge opening located and directed as to not to rele
155. eeseseeeeeeeeteeeneeeenens ME EQUIPMENT its parts and components N A producing sparks in NORMAL USE and CONDITION complied with temperature requirements of G 5 2 and Umax and Imax occurring in their circuits and complied as follows Measured Umax lt Uzr with lp as in Fig G 1 N A Measured Umax lt Uc with Cmax as in Fig G 2 N A Measured Imax Izr With Uzr as in Fig G 1 N A Measured lmax Lt with Lmax and a Umax S 24 w N A asin Fig G3 o oeorannunann seteee cesetieetesanceceeeestes f Combinations of currents and corresponding N A voltages within the limitations IZR UZR lt 50 W extrapolated from Fig G 1 No extrapolation made for voltages above 42 V mo OONA Combinations of capacitances and N A corresponding voltages within limitations of C 2U lt 1 2 mJ extrapolated from Fig G 2 No extrapolation made for voltages above 242V a a Umax additionally determined using actual resistance R when the equivalent resistance R was less than 8000 Q Combinations of currents and corresponding N A inductances within limitations L 2I lt 0 3 mJ extrapolated from Fig G 3 No extrapolation made for inductances larger N A than 900 mH Umax Was the highest supply voltage N A occurring in circuit under investigation with sparking contact open taking into consideration MAINS VOLTAGE variations in 4 10 Imax Was the highest current flowing in circuit N A under investigation with sparki
156. ement Test Result Remark Booo o Table working voltage measurement O P U1 Pin 2 to Pin 3 U1 Pin 2 to Pin 4 YOKOGAWA 2011 10 19 20 11 13 Normal Edge CHI F57 V YOKOGAWA 2011 10 19 20 10 43 Normal Edge CHi F57 V Stopped 625kS s Auto 8 625kS s Auto a af Vai D bee fan 20ms div eet tain 20ms div AN yyy P P C1 364 Y Rms C1 219 865 Y Max C1 364 V Min C1 EAJ P P C1 355 Y Rms 1 227 315 Y Max C1 356 Y Min C1 8Y Mean C1 182 309 V Ee 50 08013 Hz Mean c 113 107 Frea ct 50 01200 Hz CY1 Primary to secondary YOKOGAWA 2011 10 19 18 18 21 Normal Edge CH1 F 258 V Stopped 154 q 1 25MS s Auto KO 200 Viiv 828 V 10ms div i i i l i i i i i Ty 50 00m 50 00ms Max C1 340 Y Minton 20 Y P P C1 360 Y Rms C1 209 757 Y Mean C1 159 967 V Freq C1 49 93209 Hz TRF No IEC60601_1G SI Page 23 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark CAE GENERAL REQUIREMENTS OP Requirements of this standard applied in NORMAL USE and reasonably foreseeable misuse A RISK MANAGEMENT PROCESS complying with ISO The risk management 14971 was performed ccceeeeeeseeeeeet reqUIrements of the standard were not addressed The power supply tested in this test report is only component level power supply 4 3 ESSENTIAL PERFORMANCE fu
157. ended for external conductors N A Screws and nuts clamping external conductors do not serve to secure any other component except they also clamp internal conductors when unlikely to be displaced when fitting the supply conductors Arrangement of MAINS TERMINAL DEVICES a Terminals provided for connection of external cords or POWER SUPPLY CORDS together with PROTECTIVE EARTH TERMINAL grouped to provide convenient means of connection b PROTECTIVE EARTH CONDUCTOR connections complied with 8 6 c Marking of MAINS TERMINAL DEVICES complied with 7 3 d MAINS TERMINAL DEVICES not accessible without use of a TOOL e A MEANS OF PROTECTION are not short circuited when one end of a flexible conductor with NOMINAL cross sectional area is stripped 8 mm and a single free wire is bent in each possible direction Internal wiring not subjected to stress and CREEPAGE and CLEARANCES not reduced below 8 9 after fastening and loosening a conductor of largest cross sectional area 10 times TRF No IEC60601_1G SIS Page 70 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Terminals with clamping means for a rewirable flexible cord did not require special preparation of conductors and conductors were not damaged and did not slip out when clamping means tightened as verified by test Adequate space provided inside ME EQUIPMENT designed for FIXED wiring or a re wirable POWER SUPPLY CORD to allow for connection
158. ended movement of a component Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information All internal components are mounted securely to prevent excessive bending Reduction of creepage and clearance distances prevented by design Glue used to fix some internal components to prevent reduction of creepage and clearance distances 8 1 b 3 RM RESULTS TABLE Fundamental rule of protection against electric shock N A accidental detachment of conductors and connectors TRF No IEC60601_1G SI gt Page 140 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 Supplementary Information No such conductors Output cable is provided with appropriate cord anchorage relevant for desk top version See enclosed pictures of the unit for details 8 2 2 RM RESULTS TABLE Connection to an external d c power sources N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary Information Mains operated equipment 8 3 d RM RESULTS TABLE Requirements of Type BF or CF Applied Parts N A Clause of
159. ent Single fault condition supply 264 60 112 4 Measured on output interruption normal polarity before humidity treatment TRF No IEC60601_1G SLE Page 148 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Single fault condition supply 264 60 112 5 Measured on output interruption reverse polarity before humidity treatment Model GTM 21089 series Normal condition normal polarity 264 60 90 2 Measured on output after humidity treatment Normal condition reverse polarity 264 60 80 8 Measured on output after humidity treatment Single fault condition supply 264 60 132 8 Measured on output interruption normal polarity after humidity treatment Single fault condition supply 264 60 132 7 Measured on output interruption reverse polarity after humidity treatment Model GTM 21096 series Normal condition normal polarity 264 60 81 0 Measured on output after humidity treatment Normal condition reverse polarity 264 60 80 8 Measured on output after humidity treatment Single fault condition supply 264 60 115 0 Measured on output interruption normal polarity after humidity treatment Single fault condition supply 264 60 114 9 Measured on output interruption reverse polarity after humidity treatment Fig 15 Patient Leakage Current P Maximum allowed values Type B or BF AP 10 uA NC 50 uA SFC d c current
160. ent devices PTC s complied with IEC 60730 1 1999 clauses 15 17 J 15 and J 17 as applicable ME EQUIPMENT containing THERMAL CUT OUTS and See appended Table 13 2 OVER CURRENT RELEASES operated under the conditions of Clause 13 csseeeeeeeeeeeeeeeees f SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTc s Certified according to appropriate standards In the absence of Certification in accordance with IEC standards SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTC s operated 200 times Manual reset THERMAL CUT OUTS and OVER No such components CURRENT RELEASES Certified in accordance with incorporated within the appropriate IEC standards equipment When certification based on IEC standards or data from MANUFACTURER demonstrating reliability of component to perform its safety related function is not available manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES operated 10 times Thermal protective devices tested separately No thermal protective from ME EQUIPMENT when engineering judgment devices incorporated indicated test results would not be impacted g Protective device provided on ME EQUIPMENT incorporating a fluid filled container with heating means operated when heater switched on with container empty and prevented an unacceptable RISK due
161. enthetevetsve edict ceveeehecc osteitis AIR CLEARANCE for MAINS PARTS operating on mo RATED MAINS VOLTAGES up to 300 V were values for r m s or d c RATED MAINS VOLTAGE in Table 13 plus additional CLEARANCE in Table 14 for PEAK WORKING VOLTAGE 8 9 1 11 SUPPLY MAINS overvoltage category Il applied according to IEC 60664 1 For ME EQUIPMENT intended for overvoltage category Ill Tables 13 to 15 inclusive not used for clearance instead values in the next MAINS TRANSIENT VOLTAGE column a used A SECONDARY CIRCUIT derived from a SUPPLY MAINS normally considered to be overvoltage category according to IEC 60664 1 when the MAINS PART is overvoltage category II Table 15 Requirements for primary circuits in Tables 13 and 14 used for an unearthed SECONDARY CIRCUIT derived from a SUPPLY MAINS Table 15 applied when SECONDARY CIRCUIT was separated from MAINS PART by a functionally earthed or PROTECTIVELY EARTHED metal screen or transients in SECONDARY CIRCUIT were below the levels expected for overvoltage category TRF No IEC60601_1G SIS Page 62 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark d c SECONDARY CIRCUITS reliably connected to N A earth and have capacitive filtering limiting peak to peak ripple to 10 of d c voltage and Circuits in INTERNALLY POWERED ME EQUIPMENT EUT is not internally N A powered equipment 8 9 1 13 For PEAK WORKING VOLTAGES above 1400 V peak No such
162. er case no HAZARD or damage resulted TRF No IEC60601_1G SI Page 73 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark when protective measure was in a SINGLE N A FAULT CONDITION and an unacceptable RISK could arise one or more emergency stopping device s provided RISK MANAGEMENT FILE reviewed and all N A conditions confirmed 9 2 2 5 Continuous activation eel TRAPPING ZONE not considered to present a MECHANICAL HAZARD where impractical to make TRAPPING ZONE inaccessible when a movement was in OPERATOR S field of view b movement of ME EQUIPMENT or its parts was possible only by continuous activation of control by OPERATOR as long as OPERATOR response to deactivate device relied upon to prevent HARM Manually operated movements complied with N A this clause since mass and velocity allowed adequate control of positioning without causing an unacceptable RISK c when in a SINGLE FAULT CONDITION of See Appended RM Results continuous activation system an unacceptable Table 9 2 2 5 c RISK could arise one or more emergency stopping device s provided in ME EQUIPMENT unacceptable RISK Over travel stopping distance of such movement occurring after operation of a control to stop movement did not result in an unacceptable RISK Other HAZARDS associated with moving parts Controls positioned recessed or protected by No moving parts other means and could not be ac
163. exhaust outlets of an OXYGEN RICH ENVIRONMENT when electrical components mounted outside of ME EQUIPMENT or ME SYSTEM 11 2 2 3 Electrical connections within a compartment containing an OXYGEN RICH ENVIRONMENT under NORMAL USE did not produce sparks due to loosening or breaking except when limited in power and energy to values in 11 2 2 1 a 5 Screw attachments protected against loosening during use by varnishing use of spring washers or adequate torques z Soldered crimped and pin and socket connections of cables exiting ENCLOSURE include additional mechanical securing means 11 2 3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS ME EQUIPMENT and ME SYSTEMS considered Failure of a ventilation system constructed in accordance with 11 2 2 1 b 2 Failure of a barrier constructed in accordance with 11 2 2 1 b 3 Failure of a component creating a source of ignition as defined in 11 2 2 1 a Failure of solid insulation or creepage and clearances providing equivalent of at least one MEANS OF PATIENT PROTECTION but less than two MEANS OF PATIENT PROTECTION that could create a source of ignition defined in 11 2 2 1 a Failure of a pneumatic component resulting in leakage of oxygen enriched gas Constructional requirements for fire ENCLOSURES of ME EQUIPMENT A i TRF No IEC60601_1G SI Page 91 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Rema
164. f normal operation of ME EQUIPMENT e Emergency switching operation or stopping means neither introduced further HAZARD nor interfered with operation necessary to remove original HAZARD No emergency stopping device provided f Emergency stopping device was able to break full load of relevant circuit including possible stalled motor currents and the like g Means for stopping of movements operate as a result of one single action h Emergency stopping device provided with an actuator in red and easily distinguishable and identifiable from other controls j Emergency stopping device once actuated maintained ME EQUIPMENT in disabled condition until a deliberate action different from that used to actuate it was performed k Emergency stopping device is suitable for its application Means provided to permit quick and safe release of PATIENT in event of breakdown of ME Table 9 2 5 EQUIPMENT or failure of power supply activation of a protective measure or emergency stopping and Uncontrolled or unintended movement of ME EQUIPMENT that could result in an unacceptable RISK prevented i An actuator interrupting opening mechanical movements marked on or immediately adjacent to face of actuator with symbol 18 of Table D 1 symbol IEC 60417 5638 DB 2002 10 or STOP TRF No IEC60601_1G SI Page 75 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Situations where PATI
165. f the max RATED MAINS VOLTAGE and after relevant tests of Clause 11 6 i e overflow spillage leakage ingress of water and particulate matter cleaning amp disinfection amp sterilization ER Earth leakage current A After humidity conditioning TC Touch current B Before humidity conditioning P Patient leakage current 1 Switch closed or set to normal polarity PA Patient auxiliary current 0 Switch open or set to reversed polarity TP Total Patient current NC Normal condition PM Patient leakage current with mains on the applied parts SFC Single fault condition MD Measuring device Supplementary information Bridging capacitor provided between primary and secondary circuit CY1 1000 pF Touch current measured on the output for Class Il power supply units no protective earthing provided Earth current measured on the models with protective earth 8 8 3 TABLE Dielectric strength test of solid insulating materials with safety function P MEANS OF OPERATOR PROTECTION MOOP MEANS OF PATIENT PROTECTION MOPP Reference Voltage i i Insulation under test Insulation Type A C test Pa area from insulation 1or2 PEAK WORKING PEAK WORKING voltages in V Beanie diagram MOOP MOPP VOLTAGE U VOLTAGE U r m s 2 Yes No V peak V d c Primary to plastic 2 x MOOP 354 V peak 3 000 Vac No break enclosure down of the See a below insulation Primary to 2 x
166. fore N A must not be used with a generic statement that the component is certified Insulation diagram is a graphical representation of equipment insulation barriers protective impedance and protective earthing If feasible use the following conventions to generate the diagram All isolation barriers are identified by letters between separate parts of diagram for example separate transformer windings optocouplers wire insulation creepage and clearance distances Parts connected to earth with large dots are protectively earthed Other connections to earth are functional Applied parts are extended beyond the equipment enclosure and terminated with an arrow Parts accessible to the operator only are extended outside of the enclosure but are not terminated with an arrow TRF No IEC60601_1G SLE Page 20 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ratte wong vonage measurament Sid A a aze m w p Pnswoo m a Rar ane oaoa Pin 4 to GND 213 o 352 O ee a5 Pin 3 to Pin 6 Optocoupler U1 Pin 1 to Pin 3 363 pinttoping et Pinztoping ee tee Paterna mm Bridging capacitor CY1 Primarytoseconday 20 J w ooo o supplementary information Model GTM21089 1824 24 Vdc 0 75 A Input voltage 240 Vac Rated output load Minus of the output input N and PE were connected and marked as GND T1 Pin 1 to GND T1 Pin 2 to GND YOKOGAWA 2011 10 19 21 04 47 Norma
167. green coloured band is gt 4 cm and size of marking is as large as possible for particular case When above marking not possible relevant information included in instructions for use TRF No IEC60601_1G SI Page 119 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Marking complied with tests and criteria of 7 1 2 and 7 1 3 When above marking not possible the relevant information included in instructions for use Marking complied with tests and criteria of 7 1 2 and 7 1 3 The marking according to G 3 2 and G 3 3 placed on major part of ME EQUIPMENT for CATEGORY AP or APG parts and not repeated on detachable parts that can only be used with the marked EQUIPMENT ACCOMPANYING DOCUMENTS contain an indication enabling the RESPONSIBLE ORGANIZATION to distinguish between CATEGORY AP and APG parts Marking clearly indicates which parts are CATEGORY AP or APG when only certain ME EQUIPMENT parts are CATEGORY AP or APG a CREEPAGE and CLEARANCES between points of POWER SUPPLY CORD connection are according to Table 12 for one MEANS OF PATIENT PROTECTION b Connections except those in circuits described in G 5 3 and G 6 3 protected against accidental disconnection in NORMAL USE or connection and disconnection can be performed only with a TOOL c CATEGORY AP and APG not provided with a DETACHABLE POWER SUPPLY CORD except when circuit complied with G 5 3 and G 6 3 a Opening of an
168. gth of patient or operator support or suspension N A systems General TRF No IEC60601_1G SIS Page 175 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 3 2 TABLE PATIENT support suspension system Static forces ME EQUIPMENT part Load Area or area Ee I 9 8 3 2a b RM RESULTS TABLE Static forces due to loading from persons N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 3 3 TABLE Support Suspension System Dynamic forces due to loading from N A persons ME EQUIPMENT Safe Working Area part or area Load Supplementary Information TRF No IEC60601_1G SI Page 176 of 279 Report No T223 0330 12 9 8 4 1 RM RESULTS TABLE Systems with mechanical protective devices General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 9 8 4 3 RM RESULTS TABLE Mechanical protective devi
169. hin INTERNAL ELECTRICAL POWER SOURCE to protect against fire caused by excessive currents when in case of a short circuit layout of internal wiring cross sectional area rating of connected components can result in a fire Justification for OVER CURRENT RELEASES or FUSE exclusion is included in RISK MANAGEMENT FILE Indicator lights provided to indicate ME EQUIPMENT is ready for NORMAL USE except when apparent to OPERATOR from normal operating position and marking of 7 4 1 are insufficient for this purpOSe ccceeeeeeeeree i An additional indicator light provided on ME EQUIPMENT with a stand by state or a warm up state exceeding 15 s except when apparent to OPERATOR from normal operating position Indicator lights provided on ME EQUIPMENT incorporating non luminous heaters to indicate heaters are operational when a HAZARDOUS SITUATION could exist except when apparent to OPERATOR from normal operating position TRF No IEC60601_1G Protective device has adequate breaking capacity to interrupt the maximum fault current See Appended RM Results Table 15 4 3 1 No batteries inside power supply unit provided Mains operated equipment See Appended RM Results Table 15 4 3 2 See Appended RM Results Table 15 4 3 3 See Appended RM Results N A Table 15 4 3 4 Tests of IEC 60086 4 waived on the lithium N A battery based on examination of design N A See Appended RM Results Table 15 4 3 5 See Appended R
170. hree layers of material for which all See appended Table 8 8 3 combinations of two layers together passed the appropriate dielectric strength test Approved triple insulated wire TIW used for secondary windings See list of critical components for details Dielectric strength test for one or two layers was same as for one MEANS OF PROTECTION for SUPPLEMENTARY INSULATION Dielectric strength test for one or two layers was same as for two MEANS OF PROTECTION for REINFORCED INSULATION except when c Wire with solid insulation other than solvent based enamel complying with a d Wire with multi layer extruded or spirally Approved triple insulated wrapped insulation complying with b and wire TIW used for complying with Annex L secondary windings See list of critical components for details e Finished wire with spirally wrapped or multi layer extruded insulation complying with BASIC INSULATION minimum two wrapped layers or one extruded layer SUPPLEMENTARY INSULATION minimum two layers wrapped or extruded REINFORCED INSULATION minimum three layers wrapped or extruded BASIC SUPPLEMENTARY and REINFORCED INSULATION required between windings of wound components separated by interleaved insulation complying with a or b or both TRF No IEC60601_1G SIS Page 58 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark In d and e for spirally wrapped insulation w
171. ical energy or an electrophysiological signal to or from PATIENT is TYPE BF or CF APPLIED PART c An APPLIED PART not covered by a or b is a N A TYPE B BF or CF d Requirements of a TYPE B APPLIED PART N A applied to a part in 4 6 to be subjected to requirements for an APPLIED PART except marking Requirements for a TYPE BF or CF APPLIED PART See Appended RM Results N A applied as in RISK MANAGEMENT PROCESS Table 8 3d ZE Limitation of voltage current or energy R PATIENT CONNECTIONS intended to deliver Current NA Limits in 8 4 2 not applied to currents intended No patient connections to flow through body of PATIENT to produce a physiological effect during NORMAL USE ACCESSIBLE PARTS including APPLIED PARTS oP a Currents from to or between PATIENT See appended Table 8 7 CONNECTIONS did not exceed limits for PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT per Tables 3 and 4 when measured according tO Clause 8 7 24 wines ss svcvaddvcediasasevavadsveaciasevevvaaissecen b LEAKAGE CURRENTS from to or between See appended Table 8 7 ACCESSIBLE PARTS did not exceed limits for TOUCH CURRENT in Cl 8 7 3 c when measured on enclosure metal foil per Clause 8 7 4 MA cccesessesseeeeereneeeees used E c Limits specified in b not applied to parts See Appended RM Results Measured on the output and when probability of a connection to a PATIENT Table 8 4 2c directly or through body of OPE
172. ices Temperatures measured as specified in 11 1 3 d N A Temperatures did not exceed limits of Table 26 N A N A 13 2 11 Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS N A 13 2 12 Failure of parts that might result in a MECHANICAL HAZARD See 9 amp 15 3 N A TRF No IEC60601_1G SI gt Page 199 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Supplementary information 1 Test with short circuited capacitor not performed when motor provided with a capacitor complying with IEC 60252 1 and the ME EQUIPMENT not intended for unattended use including automatic or remote control See Attachment and appended Table 8 10 There was no flame extensive smoke or melted metal during single fault testing When components were failing the test was repeated two times 13 2 6 RM RESULTS TABLE Leakage of liquid N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 14 1 RM RESULTS TABLE Programmable electrical medical systems General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information
173. icult to operate the medical product disconnection device when an APPLIANCE COUPLER or separable plug is used as isolation means to meet 8 11 1 a Necessary information provided for OPERATOR to bring ME EQUIPMENT into operation including initial control settings and connection to or positioning of PATIENT prior to use of ME EQUIPMENT its parts or ACCESSORIES Information provided to operate ME EQUIPMENT Detailed instruction including explanation of controls displays and concerning mounting of the signals sequence of operation connection of power supply unit open detachable parts or ACCESSORIES replacement _ frame and PCB mounted of material consumed during operation version provided within safety instructions TRF No IEC60601_1G SIS Page 42 of 279 Report No T223 0330 12 IEC 60601 1 Clause Requirement Test Result Remark Verdict Meanings of figures symbols warning Provided within safety statements abbreviations and indicator lights instructions described in instructions for use 7 9 2 10 A list of all system messages error messages Not messages provided and fault messages provided with an explanation of messages including important causes and possible action s to be taken to resolve the problem indicated by the message 7 9 2 11 Information provided for the OPERATOR to safely End product consideration N A terminate operation of ME EQUIPMENT Information provided on cleaning disinfe
174. in use No pre set controls provided c Incorrect connection of indicating device to relevant component prevented by adequate construction when it could be separated without use of a TOOL When torque values per Table 30 applied See appended Table 15 4 6 between control knob and shaft of rotating controls for not less than 2 s 10 times in each direction knobs did not rotate 000 Tests conducted by applying an axial force of See appended Table 15 4 6 60 N for electrical components and 100 N for other components for 1 min when an axial pull was required in NORMAL USE with no unacceptable RISK ccccceseesseeceeeeeeeeeeeesneeeeeees Stops of adequate mechanical strength See appended Table 15 4 6 provided on rotating movable parts of controls of ME EQUIPMENT where necessary to prevent an unexpected change from max to min or vice versa of the controlled parameter when this could cause a HAZARDOUS SITUATION 2 0000 Torque values in Table 30 applied 10 times in See appended Table 15 4 6 N A each direction to rotating controls for 2 sec Application of an axial force of 60 N for See appended Table 15 4 6 electrical components and 100 N for other components to rotating or movable parts of controls for 1 min when an axial pull was required in NORMAL USE ecceeeeseeseeeeeeeeeees TRF No IEC60601_1G SI Page 111 of 279 Report No T223 0330 12 IEC 60601 1 Req
175. iodic checking or replacement of power source Warning to remove primary batteries when ME See Appended RM Results EQUIPMENT is not likely to be used for some time Table 7 9 2 4 when leakage from battery would result in an unacceptable RISK e ccceceseesseeneeeeeeeeeeeeees Specifications of replaceable INTERNAL ELECTRICAL POWER SOURCE when provided Warning indicating ME EQUIPMENT must be See Appended RM Results connected to an appropriate power source Table 7 9 2 4 when loss of power source would result in an unacceptable RISK cccceeeseesseeneeeeeeeeeeeeees i Instructions for use include a description of ME Provided within technical EQUIPMENT its functions significant physical specification and performance characteristics together with the expected positions of OPERATOR PATIENT or other persons near ME EQUIPMENT in NORMAL USE Information provided on materials and ingredients PATIENT or OPERATOR is exposed to when such exposure can constitute an unacceptable RISK Restrictions specified on other equipment or NETWORK DATA COUPLINGS other than those forming part of an ME SYSTEM to which a SIGNAL INPUT OUTPUT PART may be connected Information provided indicating where the installation instructions may be found or information on qualified personnel who can perform the installation Instructions provided indicating not to position EUT not treated as end ME EQUIPMENT to make it diff
176. ion N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 Supplementary information 14 13 RM RESULTS TABLE Connection of PEMS by NETWORK DATA COUPLING N A to other equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 TRF No IEC60601_1G SI Page 201 of 279 Report No T223 0330 12 14 13 RM RESULTS TABLE Connection of PEMS by NETWORK DATA COUPLING N A to other equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 Supplementary information 15 1 RM RESULTS TABLE Construction of ME equipment Arrangements of N A controls and indicators of ME equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information Power supply unit is provided without controls and indicators Power supply unit is not end medical product End product consideration 15 3 TABLE Mechanical Strength tests 1 P Clause Name of Test Test conditions Observed results Remarks 15 3 2 Push Test Force 250 N 10 N for 5s Test performed on external parts of the enclosure No damage of the enclo
177. ith CREEPAGE DISTANCES between layers less than in Table 12 or 16 Pollution Degree 1 depending on type of insulation path between layers sealed as a cemented joint in 8 9 3 3 and test voltages of TYPE TESTS in L 3 equal 1 6 times of normal values Protection against mechanical stress provided where two insulated wires or one bare and one insulated wire are in contact inside wound component crossing at an angle between 45 and 90 and subject to winding tension i Finished component complied with routine dielectric strength tests Of 8 8 3 ccccseseeseee Tests of Annex L not repeated since material See Table 8 10 and Material data sheets confirm compliance Information Attachment Sufficient evidence for complying with Means of Operator Protection Solid insulating materials with a safety function withstood dielectric strength test Resistance to heat retained by all insulation and insulating partition walls during EXPECTED SERVICE LIFE of ME EQUIPMENT ME EQUIPMENT and RISK MANAGEMENT FILE See Appended RM Results examined in conjunction with resistance to Table 8 8 4 1 moisture dielectric strength and mechanical strength tests The risk management requirements of the standard were not addressed Satisfactory evidence of compliance provided Manufacturer is using by manufacturer for resistance to heat approved materials with adequate temperature characteristics See Table 8 10 No additional test
178. ithin technical address the RESPONSIBLE ORGANIZATION can be specification referred tO svssseinds hedeeceweccteceec dees cceeecssvtiavcaaveaawcaevens Provided within technical specification When ACCOMPANYING DOCUMENTS provided See Appended RM Results electronically e g on CDROM RISK Table 7 9 1 MANAGEMENT PROCESS includes instructions as to what is required in hard copy or as markings on ME EQUIPMENT for emergency operation Paper version provided ACCOMPANYING DOCUMENTS specify special skills Power supply unit is part of training and knowledge required of OPERATOR or the investigation RESPONSIBLE ORGANIZATION and environmental restrictions on locations of use ACCOMPANYING DOCUMENTS written at a level Power supply unit is part of consistent with education training and other the investigation needs of individuals for whom they are intended TRF No IEC60601_1G SIS Page 40 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark intended use of ME EQUIPMENT EUT is medical in power supply unit intended for supplying end medical product by its output voltage frequently used functions and EUT is medical in power supply unit intended for supplying end medical product by its output voltage known contraindication s to use of ME EUT is medical power EQUIPMENT supply unit therefore no contraindications to use of the equipment Instructions for use are in a language
179. l Edge CHI F 57 V YOKOGAWA Stopped 1 0 1 25MS s Auto Stopped 4 1 25MS s KO 87 Vadid D 8T Viiv Toms div 258 Main 125 k 2011 10 19 21 05 50 Normal Edge CHi F 47 V k 1 Auto Jiv 10ms div TAS Le my 30 00ns 00ms Ei Yas 50 00ms P P C1 358 Y Rms C1 213 684 Y Max G1 Min C1 if 16 Y 340 V Mean C1 160 956 V Mean C1 160 021 Y Freq C1 49 99000 Hz Max C1 3440 Min C1 15 Y PCC 5 C 213 fax C1 Mint 88427 He P P C1 356 Y Rms C1 213 002 TRF No IEC60601_1G SLE Clause Page 21 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark fe Table working voltage measurement he P T1 Pin 3 to GND YOROGAWA 2011 10 19 21 0652 Stopped q Normal 1 25MS s Edge CH1 F 42 V Auto T1 Pin 4 to GND YOKOGAWA 2011 10 19 21 0723 Stopped 72 Normal 4 1 25MS s Edge CH1 F 42 V Auto KT 200 Vavi KD 200 Vait fao v Wain 7125 k i i 1 1 i i 1 i i i i 1 j i 1 g0 v 50 00ns 10ms div 1 i i i i i i i i 50 00ms soo v Main 125 k 10ms div See SOD Se 2 aes en goo v i 50 00ms 50 00ms Max C1 vee T1 Pin 3 to Pin 5 YOKOGAWA 2011 10 19 21 08 50 Stopped 2 480 Y Min C1 34 Y P P C1 824 Y 159 537 Freq G1 49 96403 Hz q Rms C1 Normal 1 25MS s 272 34 Y Edge CH1 F
180. laration per sub clause 6 2 5 of IECEE 02 The application for obtaining a CB Test Certificate x Yes includes more than one factory location and a C Not applicable declaration from the Manufacturer stating that the sample s submitted for evaluation is are representative of the products from each factory has been Provided cseccceeceeseeeeeseeeeeeeseeeeseeeneeees When differences exist they shall be identified in the General product information section Name and address of factory ies ecesseeeeees 1 GlobTek Inc 186 Veterans Drive Northvale NJ 07647 USA 2 GlobTek Suzhou Co Ltd Building 4 No 76 Jinling East Road Suzhou Industrial Park Jiangsu 215021 China TRF No IEC60601_1G SIS Page 11 of 279 Report No T223 0330 12 General product information The Power Supply GTM21089 series GTM21096 series has been designed for the supplying various medical devices with integrated 2 x MOOP isolation means of operator protection between primary and secondary and between primary and external plastic enclosure surface and with integrated 1 x MOOP isolation means of operator protection between primary and protective earth Power supply is not intended for direct patient connection Type B type BF or type CF EUT is a desk top power supply unit Class or Class Il open frame power supply unit complies with Class or Class Il construction or PCB mounted power supply unit complie
181. lation to prevent internal short circuits that provided could cause overheating which could result in a HAZARDOUS SITUATION Dielectric strength tests were conducted in See appended Table 15 5 2 accordance with requirements of this clause with no breakdown of insulation system and no detectable deterioration of transformer Transformers forming MEANS OF PROTECTION as_ See appended Table 8 10 required by 8 5 comply with IEC 61558 1 139 Clause Di 2iainoenineo nni UAA a e eeuerenmen ERIEK the equipment After installation or subsequent modification See Appended RM Results ME SYSTEM didn t result in an unacceptable Risk Table 16 1 EUT is a single components and therefore not treated as ME system Only HAZARDS arising from combining various equipment to form a ME SYSTEM considered ME SYSTEM provides the level of safety within the PATIENT ENVIRONMENT equivalent to ME EQUIPMENT complying with this standard TRF No IEC60601_1G SI Page 113 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ME SYSTEM provides the level of safety outside N A PATIENT ENVIRONMENT equivalent to equipment complying with their respective IEC or ISO safety standards tests performed in NORMAL CONDITION except N A as specified tests performed under operating conditions N A specified by MANUFACTURER of ME SYSTEM Safety tests previously conducted on N A individual equipment of
182. lause 8 8 3 test voltage multiplied by 1 6 ccccesceesssseeeeeeens Cracks or voids in insulating compound affecting homogeneity of material didn t occur Where insulating compound forms a cemented joint with other insulating parts three samples tested for reliability of joint A winding of solvent based enamelled wire replaced for the test by a metal foil or by a few turns of bare wire placed close to cemented joint and three samples tested as follows One sample subjected to thermal cycling See appended Table 8 9 3 4 PROCEDURE of 8 9 3 4 and immediately after the last period at highest temperature during thermal cycling it was subjected to dielectric strength test of 8 8 3 except at 1 6 times the test voltage eecceeeeeceseseeeeeeeeteeeeeeeneeeeeeeesenesenens The other two samples subjected to humidity preconditioning of 5 7 except for 48 hours only followed by a dielectric strength test of 8 8 3 at 1 6 times the test voltage One sample containing the cemented joint See appended Table 8 9 3 4 subjected to a sequence of temperature cycling tests for 10 times cseseeeessseeeeeeeeens Components and wiring TRF No IEC60601_1G SIS Page 64 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Components of ME EQUIPMENT likely to result in See Appended RM Results an unacceptable RISK by their movements Table 8 10 1 mounted securely as indicated in RISK MANAGEMENT
183. le 9 8 4 3 DEVICE is ccsccussevech Sy ctveteenacctvessceexevede tees OAI ACCOMPANYING DOCUMENTS instruct once MECHANICAL PROTECTIVE DEVICE is activated SERVICE PERSONNEL shall be called and MECHANICAL PROTECTIVE DEVICE must be replaced before ME EQUIPMENT can be used ME EQUIPMENT permanently marked with safety sign 2 of Table D 2 i e safety sign 7010 W001 TRF No IEC60601_1G SI Page 85 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Marking is adjacent to MECHANICAL PROTECTIVE DEVICE or its location relative to MECHANICAL PROTECTIVE DEVICE is obvious to service personnel MANAGEMENT FILE specifications and processing of materials and following test A chain cable band spring belt jack screw nut pneumatic or hydraulic hose structural part or the like employed to support a load defeated by a convenient means causing maximum normal load to fall from most adverse position permitted by construction of ME EQUIPMENT Load included SAFE WORKING LOAD in 9 8 3 1 when system was capable of supporting a PATIENT Or OPERATOR No evidence of damage to MECHANICAL PROTECTIVE DEVICE affecting its ability to perform its intended function Support system parts have TENSILE SAFETY See Appended RM Results FACTORS gt to values in Table 21 rows 1 and 2 Table 9 8 5 and are not impaired by wear Support system parts impaired by wear however they have TENSILE SAFETY FACTORS gt
184. liability for damages resulting from the reader s interpretation of the reproduced material due to its placement and context If this Test Report Form is used by non IECEE members the IECEE IEC logo shall be removed This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02 Test item description Medical Power Supply Unit Trade Mark cssscsssssesesssesseseeneeee G GlobTek Inc Manufacturer c0csseeeeeet GlobTek Inc 186 Veterans Drive Northvale NJ 07647 USA SL gt Page 2 of 279 Report No T223 0330 12 Model Type reference usses GTM21089 YYZZ A B CD where GTM2 denotes version of the power supply unit 41089 denotes family designation YY denotes output power of the power supply unit in watts ZZ denotes output voltage of the power supply unit in volts A B denotes optional deviation subtracted from standard output voltage in 0 1 volt increments C denotes type of power supply unit T Desk top version power supply unit D denotes protection class of the power supply unit 3 Class power supply unit with protective earth C14 appliance inlet 3A Class power supply unit with protective earth C6 appliance inlet 2 Class Il power supply unit without protective earth GTM21096 YYZZ A
185. lib mm mm mm mm unless is Vrms Vpk MOOP MOPP known Model GTM21089 A1 1 x MOOP IIIb 250 354 3 0 1 6 9 9 9 9 Measured before primary fuses B 1xMOOP lilb 250 354 Verified via short circuiting See TABLE abnormal operation C 2xMOOP IIIb 250 354 5 0 4 0 7 1 5 6 Measured between primary to accessible plastic enclosure Sufficient D1 2 x MOOP IIIb 247 480 5 0 4 2 7 6 7 6 Measured on the transformer Sufficient D2 2 x MOOP Illb 247 480 5 0 4 2 5 7 6 9 Measured on PCB Sufficient D3 2x MOOP IIIb 247 480 5 0 4 2 8 0 8 0 Measured between metal shield and primary circuit Sufficient TRF No IEC60601_1G i Page 15 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark D4 2 x MOOP IIIb 247 480 5 0 4 2 Min 5 0 Min 5 0 Measured between primary heatsink over the D8 and secondary components Sufficient E 1xMOOP lll 273 480 2 9 2 1 5 6 5 6 Measured PE pin of appliance inlet and primary Sufficient Model GTM21096 A1 1xMOOP lilb 250 354 3 0 1 6 3 1 3 1 Measured before primary fuses Sufficient B 1xMOOP lilb 250 354 Verified via short circuiting See TABLE abnormal operation TRF No IEC60601_1G i Page 16 of 279 Report No T223 0330 12 IEC 60
186. lues applied equipment Material groups classified in accordance with See Insulation Table 9 Material Group cccsssseeecssseeeeeeeeees Diagram Table Material group evaluated using 50 drops of solution A based on test data for material Soror to IEC 60112 enisinia Pollution degree 1 Micro environment sealed to exclude dust and moisture Pollution degree 2 Micro environment with EUT was evaluated for use non conductive pollution except occasional within pollution degree 2 conductivity caused by condensation environmental Pollution degree 3 Micro environment subject to conductive pollution or dry non conductive pollution that could become conductive due to expected condensation TRF No IEC60601_1G SI Page 61 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Pollution degree 4 Micro environment where N A continuous conductivity occurs due to conductive dust rain or other wet conditions Pollution degree 4 not used for insulation providing a MEANS OF PROTECTION Where insulation between MAINS PART and earth might be compromised measures such as maintenance ensure that micro environment is mitigated to a lower pollution degree Overvoltage category classification value of MAINS TRANSIENT VOLTAGE determined from overvoltage category per IEC60664 1 and NOMINAL a c MAINS VOLTAGE using Table 10 V mr Peak V orat neeaaeia nei rindi VANES WV cates etiet d
187. m a fluid jet caused by leakage or a component failure Elements of ME EQUIPMENT or an ACCESSORY especially pipes and hoses leading to an unacceptable RISK protected against harmful external effects Reservoirs and similar vessels leading to an unacceptable RISK are automatically depressurized when ME EQUIPMENT is isolated from its power supply TRF No IEC60601_1G SIS Page 80 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Means provided for isolation or local depressurizing reservoirs and similar vessels and pressure indication when above not possible All elements remaining under pressure after isolation of ME EQUIPMENT or an ACCESSORY from its power supply resulting in an unacceptable RISK provided with clearly identified exhaust devices and a warning to depressurize these elements before setting or maintenance activity Maximum pressure a part of ME EQUIPMENT can be subjected to in NORMAL and SINGLE FAULT CONDITIONS considered to be highest of following a RATED maximum supply pressure from an external source b Pressure setting of a pressure relief device provided as part of assembly c Max pressure that can develop by a source of pressure that is part of assembly unless pressure limited by a pressure relief device as allowed in 9 7 7 confirmed by examination of ME EQUIPMENT and RISK MANAGEMENT FILE and by functional tests cccesceeeseseeeeeseeeeeeseen
188. manently connected to separating transformer or socket outlet of separating transformer assembly cannot accept MAINS PLUGS as identified in IEC TR 60083 Removal of any single item of equipment in ME SYSTEM will not interrupt the protective earthing of any other part without simultaneous disconnection of electrical supply to that part Additional PROTECTIVE EARTH CONDUCTORS can be detachable only by use of a TOOL Conductors connecting different items within an ME SYSTEM protected against mechanical damage 17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND ME N E SYSTEMS RISKS associated with items addressed in RISK See Appended RM Results MANAGEMENT PROCESS as confirmed by review Table 17 The risk management requirements of the standard were not addressed EUT is switch mode power supply unit Electromagnetic compatibility shall be evaluated during end medical product approval TRF No IEC60601_1G SIS Page 118 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark electromagnetic phenomena at locations where ME EQUIPMENT or ME SYSTEM is to be used as stated in ACCOMPANYING DOCUMENTS s000 introduction of electromagnetic phenomena into environment by ME EQUIPMENT or ME SYSTEM that might degrade performance of other devices electrical equipment and systems ANNEX G PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE N ANESTHETIC MIXTURES Locations and basic requi
189. mation The risk management requirements of the standard were not addressed 11 1 2 1 RM RESULTS TABLE Applied parts intended to supply heat to patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No applied parts Power supply unit is part of the investigation 11 1 2 2 RM RESULTS TABLE Applied parts not intended to supply heat to patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 TRF No IEC60601_1G SI gt Page 185 of 279 Report No T223 0330 12 11 1 2 2 RM RESULTS TABLE Applied parts not intended to supply heat to patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 6 4 6 5 Supplementary information No applied parts Power supply unit is part of the investigation 11 1 3 TABLE Temperature of windings by change of resistance method N A Temperature T of winding t C R1 Q tz C R Q T C Allowed Insulatio Tmax C n class Supplementary information Switch mode transformer incorporated Temperature rise measured on the power transformer windings was measured
190. ment supplied as a part of ME SYSTEM to MULTIPLE SOCKET OUTLET permissible environmental conditions of use N A for ME SYSTEM including conditions for transport and storage instructions to OPERATOR not to N A simultaneously touch parts referred to in 16 4 and PATIENT d the following instructions provided for use N A by RESPONSIBLE ORGANIZATION adjustment cleaning sterilization and N A disinfection PROCEDURES assembly of ME SYSTEMS and modifications N A during actual service life shall be evaluated based on the requirements of this standard TRF No IEC60601_1G SI Page 115 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Instructions for use of ME EQUIPMENT intended to receive its power from other equipment in an ME SYSTEM describe the other equipment to ensure compliance with these requirements Parts of non ME EQUIPMENT in PATIENT ENVIRONMENT Subject to contact by OPERATOR during maintenance calibration after removal of covers connectors etc without use of a TOOL operated at a voltage lt voltage in 8 4 2 c supplied from a source separated from SUPPLY MAINS by two MEANS OF OPERATOR PROTECTION 16 5 Safety measures incorporating a SEPARATION DEVICE applied when FUNCTIONAL CONNECTION between ME EQUIPMENT and other items of an ME SYSTEM or other systems can cause allowable values of LEAKAGE CURRENT to exceed SEPARATION DEVICE has dielectric strength CREEPAGE
191. mits specified in c above also applied to the following internal parts other than contacts of plugs No openings provided connectors and socket outlets touchable by test pin in Fig 8 inserted through an opening in an ENCLOSURE and End product consideration for open frame and PCB mounted versions internal parts touchable by a metal test rod No openings provided with a diameter of 4mm and a length of 100 mm inserted through any opening on top of ENCLOSURE or through any opening provided for adjustment of pre set controls using a TOOL End product consideration for open frame and PCB mounted power supply unit Test pin or the test rod inserted through No openings provided relevant openings with minimal force of no more than 1 N End product consideration for open frame and PCB mounted power supply unit Test rod inserted in every possible position No pre set controls through openings provided for adjustment of provided pre set controls that can be adjusted in NORMAL USE with a force of 10 N Test repeated with a TOOL specified in instructions for use Test rod freely and vertically suspended through openings on top of ENCLOSURE e Devices used to de energize parts when an ACCESS COVER opened without a TOOL gives access to parts at voltages above levels permitted by this Clause comply with 8 11 1 for mains isolating switches and remain effective in SINGLE FAULT CONDITION A TOOL is required when it is po
192. mperatures higher than 300 C or sparks due to overheating 4 when temperatures of parts or components exceeded 300 C atmosphere was 100 oxygen contact material solder and fuel cotton 5 when sparks provided adequate energy for ignition by exceeding limits of Figs 35 to 37 inclusive atmosphere was 100 oxygen contact material solder and fuel cotton Deviations from worst case limits in 4 and 5 See Appended RM Results above based on lower oxygen concentrations Table 11 2 2 1 or less flammable fuels justified and documented in RISK MANAGEMENT FILE Alternative test in this clause did not identify See appended Table 11 2 2 1 existence of ignition sources at highest voltage or current respectively s eccseeeeee A safe upper limit determined by dividing upper limit of voltage or current respectively with safety margin factor of three ces b RESIDUAL RISK of fire in an OXYGEN RICH See Appended RM Results ENVIRONMENT as determined by application of Table 11 2 2 1 RISK MANAGEMENT PROCESS is based on following configurations or in combination 1 Electrical components in an OXYGEN RICH See appended Tables 4 11 ENVIRONMENT provided with power supplies 11 1 1 to 11 1 2 2 inclusive having limited energy levels lower than those and Table 13 2 considered sufficient for ignition in 11 2 2 1 a as determined by examination measurement or calculation of power energy and temperatures in NOR
193. mpted from test complies with clause 4 8 Insulation forming MEANS OF OPERATOR PROTECTION and complying with IEC 60950 1 for INSULATION CO ORDINATION not tested as in 8 8 Solid insulation forming SUPPLEMENTARY or REINFORCED INSULATION for a PEAK WORKING VOLTAGE greater than 71 V provided with TRF No IEC60601_1G See appended Table 8 7 Report No T223 0330 12 Requirement Test Result Remark See appended Table 8 7 Leakage current meter with frequency characteristics as specified on Fig 12 b used See appended Table 8 7 No applied parts provided See appended Table 8 7 See appended Table 8 7 See appended Table 8 7 EUT not permanently installed equipment See appended Table 8 7 IEC approved optocoupler U1provided between primary and secondary circuit IEC approved Y1 capacitor provided between primary and secondary circuit See list if critical components for details Distance through solid insulation or use of thin sheet material SI Page 57 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark a 0 4 mm min distance through insulation or IEC approved optocoupler provided between primary and secondary circuit b does not form part of an ENCLOSURE and not subject to handling or abrasion during NORMAL USE and comprised of at least two layers of material each passed See appended Table 8 8 3 N A the appropriate dielectric strength test or t
194. n transformer 105 4 C at 39 8 C ambient temperature No fire no hazard 13 Output overload Input current 0 250 A No Supply voltage 264 Vac Output current 4 63 A Model GTM21089 1305 Maximum temperature on transformer 138 1 C at 39 8 C ambient temperature No fire no hazard After 1 hour unit damaged 14 Output overload Input current 0 469 A No Supply voltage 264 Vac Output current 0 900 A Model GTM21089 1824 Maximum temperature on transformer 107 6 C at 39 8 C ambient temperature No fire no hazard 15 Output overload Input current 0 544 A No Supply voltage 264 Vac Output current 0 570 A Model GTM21089 1948 Maximum temperature on transformer 122 4 C at 39 9 C ambient temperature No fire no hazard 16 Output overload Input current 0 422 A No Supply voltage 90 Vac Output current 1 040 A Model GTM21089 1948 Maximum temperature on transformer 164 4 C at 39 8 C ambient temperature No fire no hazard After 1 hour unit damaged 13 2 3 Overheating of transformers per Clause 15 5 SEE TABLE 15 5 1 2 and 15 5 1 3 for details No 13 2 4 Failure of THERMOSTATS according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favourable of the two N A 13 2 5 Failure of temperature limiting devices according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or inter
195. n a bent or straight position Power supply Unit is provided with plastic enclosure without openings to cover all internal parts See enclosed pictures of the unit for details End product consideration for open frame and PCB mounted power supply unit no external enclosure provided test finger of the same dimensions with a force enclosure without openings of 30 N See enclosed pictures of the unit for details End product consideration for open frame and PCB mounted power supply unit no external enclosure provided When the straight un jointed test finger entered test with the standard test finger Fig 6 was repeated if necessary by pushing the finger through the opening Test hook of Fig 7 inserted in all openings of No openings provided ME EQUIPMENT and pulled with a force of 20 N for 10s End product consideration for open frame and PCB mounted power supply unit no external enclosure provided Openings preventing entry of test finger of Fig Power supply unit is 6 mechanically tested with a straight un jointed provided with plastic N A N A TRF No IEC60601_1G SI Page 29 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark All additional parts that became accessible checked using standard test finger and by inspection Conductive parts of actuating mechanisms of No actuating mechanisms electrical controls accessible after removal of provided h
196. n mass of 135 kg and ACCESSORIES with a min mass of 15 kg unless stated by MANUFACTURER Maximum mass of PATIENT included in SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS adapted when MANUFACTURER Specified applications Max allowable PATIENT mass lt 135 kg marked On ME EQUIPMENT and stated in ACCOMPANYING DOCUMENTS Examination of markings ACCOMPANYING DOCUMENTS and RISK MANAGEMENT FILE confirmed compliance ccceeeesseeeeeeeeeeeees Part of SAFE WORKING LOAD representing mass of PATIENTS Or OPERATORS is distributed on support suspension surface representing human body as in Fig A 19 TRF No IEC60601_1G Clause Page 83 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict Part of SAFE WORKING LOAD representing mass of ACCESSORIES deployed as in NORMAL USE and when not defined at worst case position permitted by configuration or ACCESSORIES attachment on support suspension parts a Entire mass of PATIENT or OPERATOR See Appended RM Results distributed over an area of 0 1 m on a foot Table 9 8 3 2 a rest temporarily supporting a standing PATIENT or OPERATOR Compliance confirmed by examination of ME See appended Table 8 10 EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and tests PATIENT Support suspension system See appended Table 9 8 3 2 positioned horizontally in most disadvantageous posi
197. nce inside ENCLOSURE b Gasket or sealing material used to maintain See appended Table 8 10 tightness complied with aging test B b of IEC 60068 2 2 Clause 15 at 70 C 2 C and 96h c Gas tightness of ENCLOSURE containing inlets N A for flexible cords maintained when the cords were stressed by bending or pulling Cords are fitted with adequate anchorages to N A limit stresses After the test in G 5 4 b an internal N A overpressure of 400 Pa was created and 30 pulls of the value in Table G 1 applied to each flexible cord in axial direction of cord inlet and in the least favourable direction for 1s Overpressure not reduced below 200 Pa Iu Tests waived when examination of ENCLOSURE indicated it is completely sealed or gas tight without a doubt 100 degree of certainty ENCLOSURE was lt 150 C in 25 C C ssassn Steady state operating temperature of ENCLOSURE also measured C cssesseeeeeeeeeeeens CATEGORY APG ME EQUIPMENT parts and components thereof a ME EQUIPMENT its parts and components did not ignite FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE under NORMAL USE and SINGLE FAULT CONDITION ME EQUIPMENT its parts and components not complying with G 6 3 subjected to a CONTINUOUS OPERATION test after attaining thermal steady state max 3 h over a period of 10 min ina 12 2 0 4 ether by volume oxygen mixture Parts and components of CATEGORY APG ME EQUIPMENT operating in
198. nctions identified See Appended Table 4 3 and N E according to MANUFACTURER S policy for RISK RM Results Table 4 3 acceptability in RISK MANAGEMENT FILE 000 ESSENTIAL PERFORMANCE functions maintained Essential performance shall N E following particular tests as applicable be determined within the end medical equipment however for this medical power supply essential performance is considered 2 x MOOP 2 x Means of Operator Protection between primary and secondary or between primary and external plastic enclosure surface and considered 1 x MOOP 1 x Means of Operator Protection between primary and protective earth 2 x MOOP and 1 x MOOP is tested within this test report 4 4 EXPECTED SERVICE LIFE stated in RISK Risk management shall be N E MANAGEMENT FILE s0ccceseceeseeeeeeeeeeeeeeseeeeeseeeeenees addressed to the end type medical equipment 4 5 Alternative means of addressing particular See Appended RM Results N E RISKS considered acceptable based on Table 4 5 MANUFACTURER S justification that RESIDUAL RISKS resulting from application of alternative means equal to or less than RESIDUAL RISKS resulting from requirements of this standard 1 4 6 RISK MANAGEMENT PROCESS identifies parts that See Appended Insulation N A can come into contact with PATIENT but not Diagram Table and RM defined as APPLIED PARTS Subjected to the Results Table 4 6 requirements for APPLIED PARTS except for
199. nd deterioration and residual stresses from manufacturing PROCESSES Instructions on attachment of structures to a floor wall ceiling included in ACCOMPANYING DOCUMENTS making adequate allowances for quality of materials used to make the connection and list the required materials Means of attachment of ACCESSORIES prevent TRF No IEC60601_1G SI gt Page 82 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Additional instructions provided on checking adequacy of surface of structure parts will be attached to Support systems maintain structural integrity during EXPECTED SERVICE LIFE and TENSILE SAFETY FACTORS are not less than in Table 21 except when an alternative method used to demonstrate structural integrity throughout EXPECTED SERVICE LIFE or for a foot rest When test results were part of information See appended Table 8 10 testing consisted of application of a test load to support assembly equal to TOTAL LOAD times required TENSILE SAFETY FACTOR while support assembly under test was in equilibrium after 1 min or not resulted in an unacceptable RISK SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS or OPERATORS is sum of mass of PATIENTS or mass of OPERATORS plus mass of ACCESSORIES supported by ME EQUIPMENT or its parts Supporting and suspending parts for adult human PATIENTS or OPERATORS designed for a PATIENT Or OPERATOR with a mi
200. nd beads alone not used as insulation SUPPLEMENTARY or REINFORCED INSULATION Insulating material with embedded heating conductors considered as one MEANS OF PROTECTION but not two MEANS OF PROTECTION Parts of natural latex rubber aged by Rubber not used for suspending samples freely in an oxygen insulation cylinder containing commercial oxygen to a pressure of 2 1 MPa 70 kPa with an effective capacity of at least 10 times volume of samples There were no cracks visible to naked eyes after samples kept in cylinder at 70 C 2 C for 96h and afterwards left at room temperature for at least 16h CREEPAGE DISTANCES and AIR CLEARANCES CREEPAGE DISTANCES and AIR CLEARANCES are gt to values in Tables 11 to 16 inclusive except as specified in Clauses 8 9 1 2 to 8 9 1 15 Tables 11 to 16 inclusive not applied to CREEPAGE and CLEARANCES forming MEANS OF OPERATOR PROTECTION per IEC 60950 1 for INSULATION CO ORDINATION and used under conditions compliance was tested Specified min CLEARANCE applied as min No such insulation material CREEPAGE for CREEPAGE DISTANCES across glass provided mica ceramic and other inorganic insulating materials with similar tracking characteristics TRF No IEC60601_1G SIS Page 60 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark When min CREEPAGE derived from Tables 11 to Considered 16 inclusive was less than min applicable CLEARANCE value of min
201. ng contact closed taking into consideration MAINS VOLTAGE variations required in 4 10 Cmax and Lmax taken as values occurring at the N A component under investigation producing sparks Peak value considered when a c supplied o OONA TRF No IEC60601_1G SIS Page 122 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark An equivalent circuit calculated to determine equivalent max capacitance inductance and equivalent Umax and Imax either as d c or a c peak values in case of a complicated circuit Temperature measurements made according to See appended Tables 11 1 1 11 1 and Umax Imax R Lmax and Cmax 11 1 2 1 amp 11 1 2 2 determined with application of Figs G 1 G 3 Alternatively compliance was verified by N A examination of design data cccssseseees External ventilation with internal overpressure ONA ME EQUIPMENT its parts and components N A enclosed in an ENCLOSURE with external ventilation by means of internal overpressure complied with the following requirements a FLAMMABLE AESTHETIC MIXTURES WITH AIR that might have penetrated into ENCLOSURE of ME EQUIPMENT or part removed by ventilation before EQUIPMENT energized and penetration of such mixtures during operation was prevented by maintenance of overpressure by means of air without flammable gases or by physiologically acceptable inert gas e g nitrogen b el aa inside ENCLOSURE was 75 P
202. ng means of PROTECTIVE EARTH TERMINAL of ME EQUIPMENT for FIXED supply conductors or POWER SUPPLY CORDS comply with 8 11 4 3 and cannot be loosened without TOOL Screws for internal PROTECTIVE EARTH CONNECTIONS completely covered or protected against accidental loosening from outside TRF No IEC60601_1G SI gt Page 54 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Earth pin of APPLIANCE INLET forming supply Applicable for desk top connection to ME EQUIPMENT regarded as version PROTECTIVE EARTH TERMINAL PROTECTIVE EARTH TERMINAL not used for Not used for other proposal mechanical connection between different parts of ME EQUIPMENT or securing components not related to protective or functional earthing PROTECTIVE EARTH CONNECTION not used for a See Appended RM Results moving part except when MANUFACTURER Table 8 6 3 demonstrated in RISK MANAGEMENT FILE connection will remain reliable during EXPECTED SERVICE LIFE No moving parts provided a PROTECTIVE EARTH CONNECTIONS carried fault See appended Table 8 6 4 currents reliably and without excessive voltage drop b Allowable TOUCH CURRENT and PATIENT See appended Table 8 6 4 amp LEAKAGE CURRENT in SINGLE FAULT CONDITION were Clause 8 7 not exceeded when impedance of PROTECTIVE EARTH CONNECTIONS exceeded values in 8 6 4 a and Table 8 6 4 due to limited current capability of relevant circuits Surface coatings Not exce
203. ntirety but not separate functions of same APPLIED PART Possibility of an OPERATOR receiving a shock N A from such parts taken into consideration in RISK MANAGEMENT PROCESS Isolation of PATIENT CONNECTIONS of a N A DEFIBRILLATION PROOF APPLIED PART from other parts of ME EQUIPMENT accomplished as follows a No hazardous electrical energies appear See Appended Table N A during a discharge of cardiac defibrillator 8 5 5 1a b ME EQUIPMENT complied with relevant See Appended Table requirements of this standard providing BASIC 8 5 5 1b SAFETY and ESSENTIAL PERFORMANCE following exposure to defibrillation voltage and recovery time stated in ACCOMPANYING DOCUMENTS i Means provided to limit energy delivered toa See Appended Table 8 5 5 2 100 Q load to at least 90 of energy delivered to this load with ME EQUIPMENT disconnected Protective and functional earthing and potential equalization of ME EQUIPMENT Requirements of 8 6 2 to 8 6 8 applied Relevant for models with protective earth Parts complying with IEC 60950 1 for protective earthing and serving as MEANS OF OPERATOR PROTECTION but not PATIENT PROTECTION exempted from requirements of 8 6 2 to 8 6 8 O PROTECTIVE EARTH TERMINAL is suitable for connection to an external protective earthing system by a PROTECTIVE EARTH CONDUCTOR in a POWER SUPPLY CORD and a suitable plug or by a FIXED PROTECTIVE EARTH CONDUCTOR 2s csseeeeeee ah Clampi
204. ocation address 00100 Testing procedure WMT Tested by name signature Witnessed by signature Approved by signature Testing location address 2 0 Testing procedure SMT Tested by name signature Approved by signature Supervised by signature Testing location address 008 Testing procedure RMT Tested by name signature Approved by signature Supervised by signature Testing location address s0000 TRF No IEC60601_1G Page 5 of 279 Report No T223 0330 12 SIQ Slovenian Institute of Quality and Metrology TrzaSka cesta 2 1000 Ljubljana Slovenia Janez Vidmar BoStjan Glavi SL gt Page 6 of 279 Report No T223 0330 12 List of Attachments including a total number of pages in each attachment 1 Test Report 211 pages National Differences to IEC 60601 1 2005 Enclosure No 1 13 pages 2 3 Photo documentation Enclosure No 2 11 pages 4 Schematics layouts and transformer drawings Enclosure No 3 43 pages Summary of testing Tests performed name of test and test clause See next pages The risk management requirements of the standard were not addressed Testing location SIQ Slovenian Institute of Quality and Metrology Tr a ka cesta 2 1000 Ljubljana Slovenia List of countries addressed
205. on Risk associated with microwave radiation See Appended RM Results when applicable addressed in RISK Table 10 3 MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE EUT not produces microwave radiation Relevant requirements of IEC 60825 1 1993 No such components applied to lasers light emitting diodes LEDs incorporated within the and laser light barriers or similar products equipment Risk associated with visible electromagnetic See Appended RM Results radiation other than emitted by lasers and LEDS Table 10 5 when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK EUT not produces MANAGEMENT FILE electromagnetic radiation Risk associated with infrared radiation other See Appended RM Results than emitted by lasers and LEDS as applicable Table 10 6 addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE FUT not produces inirared radiation Risk associated with ultraviolet radiation other See Appended RM Results than emitted by lasers and LEDS as applicable Table 10 7 addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE EUT n t produces ultraviolet radiation PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS TRF No IEC60601_1G SI Page 87 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Temperatures on ME EQUIPMENT parts did not See appended Table 11 1 1 exceed values in Tables 22 and 23
206. on on conductors inside ME EQUIPMENT Green yellow colour of N A forming PROTECTIVE EARTH CONNECTIONS insulation of protective identified by green and yellow at least at conductor relevant for terminations models with protective earth 7 7 3 Green and yellow insulation identify only following conductors POTENTIAL EQUALIZATION CONDUCTORS No potential equalization conductors provided TRF No IEC60601_1G SI Page 39 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark FUNCTIONAL EARTH CONDUCTORS No functional earth conductor provided Neutral conductors of POWER SUPPLY CORDS are Power supply cord not part light blue specified in IEC 60227 1 or IEC of the investigation relevant 60245 1 for desk top version Colours of conductors in POWER SUPPLY CORDS in accordance with IEC 60227 1 or IEC 60245 1 Indicator lights and controls Red indicator lights mean Warning i e Power supply unit is immediate response by OPERATOR required provided without indicator lights End product consideration Yellow indicator lights mean Caution i e prompt response by OPERATOR required Other colours if used Meaning other than red yellow or green colour Meaning ME EQUIPMENT accompanied by documents Only technical specification containing at least instructions for use anda provided by the technical description manufacturer Name or trade name of MANUFACTURER and an Provided w
207. oncurrently with major parts and manually removable ACCESS COVERS were opened and detached ME EQUIPMENT heated to a temperature between Standard humidity treatment T and T 4 C for at least 4 h and placed ina performed humidity chamber with a relative humidity of 93 3 and an ambient within 2 C of T in the range of 20 C to 32 C for 48 h Relative humidity specified within technical specification 0 90 RH Power supply unit is intended for indoor use only Eg ME When failure occurred or probability of future Considered failure detected during sequence of tests per agreement with manufacturer all tests affecting results conducted on a new sample a EE TRF No IEC60601_1G SIS Page 28 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark When RISK MANAGEMENT PROCESS indicated ME See above N A EQUIPMENT can be exposed to high humidity for extended periods i e out door use test time extended proportionally h Unless stated otherwise tests in this standard Considered sequenced as in Annex B to prevent results of one test on a subsequent test Determination of APPLIED PARTS and ACCESSIBLE PARTS APPLIED PARTS identified by inspection and See clause 4 6 Remark reference to ACCOMPANYING DOCUMENTS No applied parts provided ACCESSIBLE PARTS Accessibility when necessary determined See Appended Table 5 9 2 using standard test finger of Fig 6 applied i
208. one Songtian Min Y1 FOWA UEEZOSI0 Enterprise Co Ltd Walsin AH Min 250 Vac IEC EN VDE 40001804 eee Max 1000pF 60384 14 P Min Y1 FOWX2 UL E146544 Bulk Samxon RD476M2GJ36 Max 47 uF IEC EN Accepted Capacitor TCSA Min 400 V 60601 1 C3 Min 105 C Various Various Max 47 uF IEC EN Accepted Min 400 V Sopot Min 105 C Fuse Walter ICP T1A250Vac IEC EN VDE 40012824 F1 F2 orn Co 3 6 x 10 mm 60127 3 4 for JDYX UL E56092 GTM21089 Conquer PDU T1A250Vac IEC EN VDE 40066776 Electronics 3 6x 10mm 60127 3 4 JDYX UL E82636 Bel Fuse MRT T1A250Vac IEC EN VDE 40001000 zeion 60127 3 4 JDYX UL E20624 Fuse Wickmann 382 series TR5 IEC EN VDE 5007679 F1 F2 T1A250Vac 60127 3 4 1170 0038 82455 for SAN Te JDYX2 UL E67006 GTM21096 SIBA GmbH 166050 TR5 IEC EN VDE 119113 T1A250Vac omens 8 4x7 6mm JDYX2 UL E167295 ESKA 887 017 TR5 IEC EN VDE 40016747 T1A250Vac 60127 3 4 8 4x 7 6mm JDYX2 UL E163905 Walter 2000 TR5 IEC EN VDE 40018790 Electronics Co 60127 3 4 Ltd T1A250Vac 8 4x7 6 mm JDYX2 UL E220181 TRF No IEC60601_1G SIS Page 160 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Conquer MET TR5 IEC EN VDE 40017157 Electronics T1A250Vac 60127 3 4 8 4x7 6 mm JDYX2 UL E82636 Sun East TSP TR5 IEC EN VDE 40027173 T1A250Vac earns 8 4x7 6 mm JDYX2 UL E133774 Sun East TMP TR5 IEC EN VDE 40027218 T1A250Vac 60127 314 8 4x7
209. operating in and appended RM Results worst case NORMAL USE at maximum rated Table 11 1 1 ambient operating temperature T csssee Power supply unit is evaluated only for means of operator protection Plastic enclosure of the power supply unit is not intended to be touch by the operator therefore limit 86 C applied for external plastic parts Plastic enclosure of the EUT is assumed to be touched for a time t t lt 1 second EUT is not intended to be moved from one to another location during operation The risk management requirements of the standard were not addressed Surfaces of test corner did not exceed 90 C Temperature of test corner not exceeds 90 C in normal conditions THERMAL CUT OUTS did not operate in NORMAL No thermal cut outs N A CONDITION provided 11 1 2 Temperature of APPLIED PARTS 11 1 2 1 Temperatures hot or cold surfaces and when See appended Table 11 1 2 1 N A appropriate clinical effects of APPLIED PARTS and appended RM Results supplying heat to a PATIENT determined and Table 11 1 2 1 documented in RISK MANAGEMENT FILE and instructions FOF USE ccsseeseseessesesneeeeeeeseeeneees 11 1 2 2 APPLIED PARTS not supplying heat to a PATIENT See appended Table 11 1 2 2 met Table 24 with max surface temperatures gt and appended RM Results 41 C disclosed in instructions for use and Table 11 1 2 2 No applied parts clinical effects regarding maturity of PATIENTS body su
210. ore 6 PCB near to Q2 7 PCB near to Q3 8 Capacitor C2 9 PCB near to D8 10 Inductor LF 1 11 Case top 12 Case bottom 13 PCB 14 Inside enclosure Input current A Output voltage Vdc Output current A Duration min Supplementary information Temperature rises of the transformer was measured with thermocouples Class B transformer provided inside the unit 130 C 10 C 120 C Inductor NF1 and L1 are assumed to be Class A 105 C 10 C 95 C The printed circuit board PCB is rated 130 C Max temperature determined in accordance with 11 1 3e 1 Plastic enclosure of the EUT is assumed to be touched by the operator for a time t t lt 1 second therefore limit 86 C applied for external plastic enclosure Power supply unit is not intended to be moved from one to another location during operation Test performed on desk top power supply unit to cover all versions TRF No IEC60601_1G SI Page 183 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 11 1 1 TABLE Thermal requirements Model GTM21089 1948 48 0 Vdc 0 4 A Maximum measured temperature T of Max measured temperature C Allowe part at d Tmax C 1 PCB near D4 2 Optical insulator U1 3 Capacitor C9 4 T1 winding 5 T1 core 6 PCB near to Q2 7 PCB near to Q3 8 Capacitor C2 9 Inductor LF1 10 Case top 11
211. ormed adjusted accordingly when ambient within the temperature temperature could not be maintained chamber at 40 C as specified by the manufacturer a ME EQUIPMENT tested under least favourable See Appended RM Results working conditions specified in instructions for Table 5 4a use and identified during RISK ANALYSIS except as noted Maximum ambient temperature specified by the manufacturer 40 C The risk management requirements of the standard were not addressed Atmospheric Pressure kPa sssessserseeeees Up to 2000 meters Not specified within technical specification therefore power supply unit is assumed to be operated up to 2000 meters altitude no correction factor used for determination required clearance distances b ME EQUIPMENT with adjustable or controlled No adjustable or controlled N A operating values by anyone other than SERVICE operating values provided PERSONNEL adjusted to values least favourable for the relevant test per instructions for use TRF No IEC60601_1G SI Page 27 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark c When test results influenced by inlet N A pressure and flow or chemical composition of a cooling liquid tests performed within the limits in technical description d Potable water used for cooling No provision for cooling N A provided Supply voltage during tests was the least favourable of the
212. owing in the circuit under investigation taking into account MAINS VOLTAGE variations as in 4 10 Cmax and Lmax are values occurring in relevant circuit Umax additionally determined with actual resistance R when equivalent resistance R in Fig G 5 was less than 8000 Q Peak value taken into consideration when a c supplied An equivalent circuit calculated to determine max capacitance inductance and Umax and Imax either as d c or a c peak values in case of a Complicated circuit ccccceceesseeeeeeeeeeeeeeeeeeees When energy produced in an inductance or capacitance in a circuit is limited by voltage or current limiting devices two independent components applied to obtain the required limitation even when a first fault short or open circuit in one of these components Above requirement not applied to transformers complying with this standard Above requirement not applied to wire wound current limiting resistors provided with a protection against unwinding of the wire in case of rupture TRF No IEC60601_1G SI Page 125 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Compliance verified by examination of N A CATEGORY APG ME EQUIPMENT parts and components or Temperature measurements made in See Tables 11 1 1 11 1 2 1 accordance with 11 1 or and 11 1 2 2 Umax Imax R Lmax and Cmax determined together with application of Figs G 4 G 6 sses i Alte
213. port No T223 0330 12 IEC 60601 1 Requirement Test Result Remark metal provided with an insulating lining affixed to cord anchorage except when it is a flexible bushing forming part of the cord guard in 8 11 3 6 and complying with the requirements for one MEANS OF PROTECTION c Cord anchorage prevents cord from being clamped by a screw bearing directly on cord insulation d Screws to be operated when replacing POWER SUPPLY CORD do not serve to secure any components other than parts of cord anchorage e Conductors of POWER SUPPLY CORD arranged to prevent PROTECTIVE EARTH CONDUCTOR against strain as long as phase conductors are in contact with their terminals when cord anchorage fails f Cord anchorage prevents POWER SUPPLY CORD from being pushed into ME EQUIPMENT or MAINS CONNECTOR from MAINS CONNECTOR and cord subjected 25 times to a pull applied with no jerks each time for 1s on sheath of the value in Table 18 Cord subjected to a torque in Table 18 for 1 min immediately after pull tests Cord anchorage did not allow cord sheath to N A be longitudinally displaced by more than 2 mm or conductor ends to move over a distance of more than 1 mm from their connected position N A CREEPAGE and CLEARANCES not reduced below N A limits in 8 9 It was not possible to push the cord into ME EQUIPMENT Or MAINS CONNECTOR to an extent the cord or internal parts would be damaged N A POWER SUPPLY CORDS othe
214. power supply unit PCB mounted power supply unit No accessories and detachable parts included No other options included 2010 02 01 2011 09 09 2012 07 18 From 2011 09 16 to 2012 09 14 Possible test case verdicts test case does not apply to the test object see test object does meet the requirement ccssseereeeeee test object was not evaluated for the requirement test object does not meet the requirement cssee N A Pass P N E Fail F TRF No IEC60601_1G SI gt Page 10 of 279 Report No T223 0330 12 Abbreviations used in the report NOrmal CONITION ccceceeseeeeeeeeeeeeeseneeeneeeneeenees N C single fault condition S F C means of Operator protection eeeee MOOP means of Patient protection MOPP General remarks see Attachment refers to additional information appended to the report see appended table refers to a table appended to the report The tests results presented in this report relate only to the object tested This report shall not be reproduced except in full without the written approval of the testing laboratory List of test equipment must be kept on file and available for review Additional test data and or information provided in the attachments to this report Throughout this report a X comma _ point is used as the decimal separator Manufacturer s Dec
215. r constructional feature that will minimize the possibility of its replacement by a detachable POWER SUPPLY CORD which could create a HAZARDOUS SITUATION SIS Page 220 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark c A detachable POWER SUPPLY CORD shall Power supply cord was not i comply with the applicable requirements of part of the investigation CSA C22 2 No 21 and j not be smaller than No 18 AWG and the mechanical serviceability shall be not less than 1 Type SJ or equivalent for mobile or exposed to abuse ME EQUIPMENT and 2 Type SV or equivalent for ME EQUIPMENT not exposed to abuse or Type HPN if required because of temperature NOTE 1A See CSA C22 2 No 49 for requirements on the cord types mentioned in Sub item 2 d Power supply cords shall meet the Power supply cord was not requirements of the Canadian Electrical Code part of the investigation Part I as applicable Connecting cords between equipment parts shall meet the requirements of the Canadian Electrical Code Part I as applicable Mains fuses and OVER CURRENT RELEASES See list of critical Mains fuses and OVER CURRENT RELEASES C MPonents shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 Pressure vessels No pressure vessels Pressure vessels shall comply with the previded requirements of CSA B51 as applicable Pressure relief device
216. r disconnection of plug from mains supply Maximum allowable voltage V ssscesseesesseesseesseesseesseesseeseeeseeeseeesneesneesneesseeseeseeeseeesseetoes 160 Voltage measured V Voltage Measured Between 1 2 3 4 5 6 7 8 9 10 Plug pins 1 and 2 2 6 Es Plug pin 1 and plug earth pin Plug pin 2 and plug earth pin 7 a Plug pin 1 and enclosure z 22 Plug pin 2 and enclosure ee ne 5 a Maximum allowable stored charge when measured voltage exceeded 60 v uc 145 Calculated stored charge uc Voltage Measured Between 1 2 3 4 5 6 7 8 9 10 Plug pins 1 and 2 a hg a s Plug pin 1 and plug earth pin Plug pin 2 and plug earth pin Plug pin 1 and enclosure oe 2 Le a Plug pin 2 and enclosure m m Pe Supplementary information Supply voltage 240 Vac Discharged performed at peak input voltage therefore test performed once at max and min peak input voltage See next page for details TRF No IEC60601_1G SI gt Page 143 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark YOKOGAMA Normal Edge CH1 F 402 V YOROGAMA Normal Edge CH1
217. r than for STATIONARY Power supply cord not part ME EQUIPMENT protected against excessive of the investigation bending at inlet opening of equipment or of MAINS CONNECTOR by means of an insulating cord guard or by means of an appropriately shaped opening Cord guard complied with test of IEC 60335 N A 1 2001 Clause 25 14 or ME EQUIPMENT placed such that axis of cord See appended Table 8 11 3 6 guard projected at an angle of 45 with cord free from stress and a mass equal 10 x D gram attached to the free end of cord g TRF No IEC60601_1G SI Page 69 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Cord guard of temperature sensitive material tested at 23 C 2 C and flat cords bent in the plane of least resistance Curvature of the cord radius immediately after See appended Table 8 11 3 6 N A mass attached was not less than 1 5 x D MAINS TERMINAL DEVICES PERMANENTLY INSTALLED and ME EQUIPMENT with N A Non DETACHABLE POWER SUPPLY CORD replaceable by SERVICE PERSONNEL provided with MAINS TERMINAL DEVICES ensuring reliable connection Terminals alone are not used to keep N A conductors in position except when barriers are provided such that CREEPAGE and CLEARANCES cannot be reduced below 8 9 if any conductor breaks away Terminals of components other than terminal N A blocks complying with requirements of this Clause and marked according to 7 3 7 used as terminals int
218. rame and PCB mounted power supply unit end product consideration a description of means for checking oil level in partially sealed oil filled ME EQUIPMENT or its parts when applicable a warning statement addressing HAZARDS that can result from unauthorized modification of ME EQUIPMENT according to following examples WARNING No modification of this equipment is Provided within technical allowed specification Modification of the power supply unit is not allowed WARNING Do not modify this equipment without authorization of the manufacturer TRF No IEC60601_1G SIS Page 44 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark WARNING If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment Technical description separable from instructions for use contains required information as follows information as in clause 7 2 Only technical specification provided EUT is power supply unit therefore user manual as required for end medical product is not required all applicable classifications in Clause 6 warning and safety notices and explanation of safety signs marked on ME EQUIPMENT a brief description of ME EQUIPMENT how it functions and its significant physical and performance characteristics MANUFACTURER S optional requirements for minimum qualifications of SERVICE PERSONNE
219. rd provides one means of conformity with the specified essential requirements of the Directives concerned WARNING Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard SIS Page 224 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Annex ZZB Considered informative Coverage of Essential Requirements of EC Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 90 385 EEC except the following Essential Requirement 5a Essential Requirement 7 Essential Requirement 8 bullet 5 Essential Requirement 10 Essential Requirement 11 Essential Requirement 12 Essential Requirement 14 Essential Requirement 15 Essential Requirement 16 Compliance with this standard provides one means of conformity with the specified essential requirements of the Directives concerned WARNING Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard SIS Page 225 of 279 Report No T223 0330 12 Encl No 2 Enclosure No 2 Photo documentation 12 pages including this cover page Page 226 of 279 Report No T223 0330 12 Encl No 2 GTM21089 serie
220. rd were not addressed TRF No IEC60601_1G SI Page 136 of 279 Report No T223 0330 12 7 2 5 RM RESULTS TABLE ME EQUIPMENT powered from other equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 4 Supplementary Information Mains operated equipment 7 2 13 RM RESULTS TABLE Physiological effects safety signs and warning N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 Supplementary Information EUT not produces physiological effects 7 2 17 RM RESULTS TABLE Protective packaging N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 6 4 Supplementary Information Protective packing not part of the investigation 7 3 3 RM RESULTS TABLE Batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph TRF No IEC60601_1G SI gt Page 137 of 279 Report No T223 0330 12 7 3 3 RM RESULTS TABLE Batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 S
221. red as primary Transformer is fully wrapped into insulation tape 2 layers provided TRF No IEC60601_1G Page 18 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 3 Insulation foil min thickness of 0 5 mm provided between secondary components and metal heatsink treated as primary Top and bottom side of the metal heatsink are additionally covered by 1 layer of insulation tape min 8 0 mm on both sides TRF No IEC60601_1G i Page 19 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 4 Insulation foil provided between PCB and primary shield minimum thickness 0 4 mm Insulation foil passed dielectric strength test for reinforced insulation applicable for models with protective earth 5 Insulator silpad minimum thickness 0 40 mm provided over the body of diode D8 including up side Additionally 3 layer of insulation tape provided over the insulator silpad Pa L 6 Minimum 5 0 mm distance provided between secondary capacitors C2 and C3 and primary heatsink INSULATION DIAGRAM CONVENTIONS and GUIDANCE A measured value must be provided in the value columns for the device under evaluation The symbol gt greater than sign must not be used Switch mode power supplies must be re evaluated in the device under evaluation there
222. rements Parts of CATEGORY APG ME EQUIPMENT in which a_ EUT was not tested against FLAMMABLE ANESTHETIC MIXTURE WITH AIR occurs __ hazard of ignition of are CATEGORY AP or APG ME EQUIPMENT and flammable anaesthetic complied with G 3 G 4 and G 5 mixtures FLAMMABLE AESTHETIC MIXTURE WITH AIR occurring due to a leakage or discharge of a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE from an ENCLOSURE considered 5 to 25 cm from point of occurrence ME EQUIPMENT or parts thereof specified for use with FLAMMABLE AESTHETIC MIXTURE WITH AIR in a location as in G 2 2 are CATEGORY AP or APG ME EQUIPMENT and complied with G 4 and G 5 ME EQUIPMENT or parts thereof for use with FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE location per G 2 2 are CATEGORY APG ME EQUIPMENT and comply with G 4 and G 6 ME EQUIPMENT in G 2 3 to G 2 5 met appropriate tests of G 3 G 5 conducted after tests of 11 6 6 and 11 6 7 Marking ACCOMPANYING DOCUMENTS N A G CATEGORY APG ME EQUIPMENT prominently See copies of Marking N A marked With a green coloured band gt 2 cm wide with letters APG according to symbol 23 A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE contained in a completely partly enclosed ME EQUIPMENT part and in PATIENT S respiratory tract 5 cm from an ENCLOSURE part where leakage or discharge occurs G 2 1 3 1 in Table Dit ioc cess deci cccdevascawedacccoces caecedevssacatobececen Length of
223. res of the unit for details 8 10 2 RM RESULTS TABLE Fixing of wiring N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information Output cable is provided with cord anchorage to prevent displacement of the secondary cable in case of accidental displacement desk top version Open frame and PCB mounted versions are provided with input output connector see enclosed pictures of the unit for details 8 10 5 RM RESULTS TABLE Mechanical protection of wiring N A TRF No IEC60601_1G SLE Page 165 of 279 Report No T223 0330 12 IEC 60601 1 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information No moving parts provided 8 11 3 5 TABLE Cord anchorages N A Cord under test Mass of Pull N Torque Nm Remarks equipment kg Supplementary information Cord anchorage provided only for secondary cable See enclosed pictures of the unit for details 8 11 3 6 TABLE Cord guard N A Cord under test Test mass Measured curvature Remarks Supplementary information 8 11 5 RM RESULTS TABLE Mains fuses and over current releases N A Claus
224. rface surface pressure medications taken as shown in RISK MANAGEMENT FILE Surfaces of APPLIED PARTS cooled below ambient temperatures that can also result in HAZARD evaluated as part of RISK MANAGEMENT PROCESS 11 1 3 Measurements not made when engineering See appended Table 11 1 3 judgment and rationale by MANUFACTURER and RM Results Table 11 1 3 indicated temperature limits could not exceed as documented in RISK MANAGEMENT FILE Temperature measurements performed TRF No IEC60601_1G SIS Page 88 of 279 IEC 60601 1 Requirement Test Result Remark Test corner not used where engineering judgment and rationale by MANUFACTURER indicated test corner will not impact measurements as documented in RISK MANAGEMENT FILE Probability of occurrence and duration of contact for parts likely to be touched and for APPLIED PARTS documented in RISK MANAGEMENT Report No T223 0330 12 Test corner used Power supply unit is evaluated only for means of operator protection FILE A Plastic enclosure of the power supply unit is not intended to be touch by the operator therefore limit 86 C applied for external plastic parts Plastic enclosure of the EUT is assumed to be touched for a time t t lt 1 second EUT is not intended to be moved from one to another location during operation The risk management requirements of the standard were not addressed 11 1 4 GUARDS preventing contact with
225. risk management or by RISK MANAGEMENT PROCESS csccseeseeeeeeeeees requirements of the standard were not addressed IEC approved components provided within the equipment See Table 8 10 List of critical components Reliability of components used as MEANS OF P PROTECTION assessed for conditions of use in ME EQUIPMENT and they complied with one of the following a Applicable safety requirements of a relevant Approved critical P IEC or ISO standard components used b Requirements of this standard applied in the P absence of a relevant IEC or ISO standard 4 9 A COMPONENT WITH HIGH INTEGRITY See appended Table 8 10 amp N E CHARACTERISTICS provided because a faultina RM Results Table 4 9 particular component can generate an unacceptable RISK ccsecceseeeseeeeseeeeseeeeeeeeees The risk management requirements of the standard were not addressed TRF No IEC60601_1G SI Page 25 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Verdict COMPONENTS WITH HIGH INTEGRITY See Appended RM Results N E CHARACTERISTICS selected and evaluated Table 4 9 consistent with their conditions of use and reasonable foreseeable misuse during EXPECTED SERVICE LIFE of ME EQUIPMENT by reviewing RISK MANAGEMENT FILE 220000 The risk management requirements of the standard were not addressed 4 10 Power supply 4 10 1 ME EQUIPMENT is Suit
226. rk ME EQUIPMENT met this clause for alternate See Appended RM Results means of compliance with selected HAZARDOUS Table 11 3 SITUATIONS and fault conditions in 13 1 2 k EUT complies with the construction requirements for fire enclosure In addition single fault as specified within the standard performed Not relevant for open frame and PCB mounted version no external enclosure provided Constructional requirements were met or Power supply unit is provided with plastic enclosure without openings Flammability UL94 V 1 minimum All internal components are mounted on the PCB rated UL94 V 1 minimum Output cable is classified as VW 1 Short circuit on the cable output performed No deformation of the cable no hazard constructional requirements specifically See Appended RM Results N A analysed in RISK MANAGEMENT FILE sseeccsssseeees Table 11 3 Justification when requirement not met Se Lee a Flammability classification of insulated wire See appended Table 8 10 within fire ENCLOSURE is FV 1 or better based on IEC 60695 series as determined by examination of data on materials Output cable is classified as VW 1 Short circuit on the cable performed No deformation of the cable no fire no emission of flames no hazard Flammability classification of connectors See appended Table 8 10 printed circuit boards and insulating material on which components are mounted is F
227. rk Verdict This standard applies to the BASIC SAFETY Considered and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be installed in accordance with the Canadian Electrical Code CEC Part 1 CSA C22 1 CAN CSA C22 2 No 0 and CAN CSA Z32 NOTE 1A In the IEC 60601 standards series adopted for use in Canada the Canadian particular standards may modify replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements assess independently compliance with the adopted Canadian collateral standards A requirement of a Canadian particular safety Considered standard takes precedence over this standard Normative references Considered The following referenced documents are indispensable for the application of this document For dated references the applicable corresponding Canadian adopted IEC standards shall take precedence For undated references the latest edition of the referenced document including any amendments applies All Canadian adopted IEC part 2 standards are referenced with the date of publication Applicable Canadian collateral standards Considered become normative at the date of their publication and apply together with this standard NOTE 1 When evaluating compliance with CAN CSA C22 2 No 60601 1 it is pe
228. rload P 15 5 2 Transformer dielectric strength after humidity preconditioning of 5 7 N A Working voltage Measurement P Evaluation of voltage limiting components in SELV circuits P TRF No IEC60601_1G SIS Page 9 of 279 Report No T223 0330 12 GENERAL INFORMATION Test item particulars see also Clause 6 Classification of installation and USEC cccccceeesseeeseeees Device type component sub assembly equipment SYSCOM PE E S T T E S A iavsuee Intended use Including type of patient application location si isos aids cto ether erential atte Mode Of Operation ccccceesseeceeceeeeeeeeeneeeeeeeeeeeseeeneeeeeeeneees SUPPly CONNECTION sisieun iei an aen asaran naana aaa ranean i Accessories and detachable parts included 2 5 Other Options include cccceeeeeeeeeeeeeeeeeeeeeeeeseneeeeeeeeeees Testing Date of receipt of test iterm S cccceeseeeeseseeeeeeesteeeeeeseenenneees Dates tests performed c eceeceeeeeeeeeeeeceeeeeseeeeeeneeeeeeeeeneel Desk top power supply unit Class I with or without protective earth Open frame power supply unit PCB mounted power supply unit Not defined end product consideration Component level power supply EUT is intended to provide power to medical devices with isolation grade MOOP Continuous operation Appliance inlet desk top power supply unit Input connector open frame
229. rmissible to SIS Page 216 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark CSA Canadian Standards Association Considered B51 03 Boiler pressure vessel and pressure piping code C22 1 06 Canadian Electrical Code Part I CAN CSA C22 2 No 0 M91 R2006 General requirements Canadian Electrical Code Part ll C22 2 No 21 95 R2004 Cord sets and power supply cords C22 2 No 42 99 R2004 General use receptacles attachment plugs and similar wiring devices C22 2 No 49 06 Flexible cords and cables CAN CSA E61558 2 1 03 Safety of power transformers power supply units and similar Part 2 Particular requirements for separating transformers for general use CAN CSA Z32 04 Electrical safety and essential electrical systems in health care facilities SLE Page 217 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Z305 series of Standards Considered CAN CSA Z305 1 92 R2001 Non flammable medical gas piping systems CAN CSA Z305 6 92 R2007 Medical oxygen concentrator central supply system for use with non flammable medical gas piping systems CAN CSA Z305 8 03 Medical supply units CAN CSA Z305 12 98 R2004 Guide for the safe storage handling and use of portable oxygen systems in home domiciliary and healthcare settings CAN CSA Z5359 04 Low pressure hose assemblies for use with medical ga
230. rnatively compliance verified by N A comparison with design data ME EQUIPMENT its parts and components See appended Table 8 10 heating a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE provided with a non SELF RESETTING THERMAL CUT OUT and complica WITTE 1542 sc aE E TT T TTT Current carrying part of heating element is not N A in direct contact with FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE G7 o Test apparatus for flammable mixtures Test apparatus used was in accordance with this Clause and Fig G 7 ANNEX L INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVED N A INSULATION BASIC SUPPLEMENTARY DOUBLE and REINFORCED Approved triple insulation INSULATION in wound components without wire used interleaved insulation complied with this Annex covering round winding wires between 0 05 mm and 5 00 mm diameters Wire construction Overlap of layers when wire is insulated with N A two or more spirally wrapped layers of tape is adequate to ensure continued overlap during manufacture of wound component See list of critical components for details Layers of spirally wrapped wire insulation are sufficiently secured to maintain the overlap mes o a a The wire subjected to tests of L 3 1 to L 3 4 at a temperature and a relative humidity specified Temperature C ccscscecsssseeeeeessseeeeesseeeenseeeeees Humidity Vo eecccceeeeeeeeeeseeeeeeeseeeeeeeseeeeesseaneeeesees Dielectric
231. roducing a short circuit resulting in operation of an overcurrent protection device i Parts within ENCLOSURE of ME EQUIPMENT with a circuit gt 42 4 V peak a c or 60 V d c that cannot be disconnected from its supply by an external switch or a plug device accessible at all times is protected against touch even after opening ENCLOSURE by an additional covering f A suitable plug device such as an APPLIANCE See appended Table 8 10 COUPLER or a flexible cord with a MAINS PLUG TRF No IEC60601_1G SI Page 67 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark A clear warning notice is marked on outside of ME EQUIPMENT to indicate it exceeds allowable touch voltage symbol 10 of Table D 1 is insufficient For a part that could not be disconnected from supply by an external switch or a plug device accessible at all times the required cover or warning notice complied with this clause o Standard test finger of Fig 6 applied Eo N A MULTIPLE SOCKET OUTLETS integral with ME No multiple socket outlet N A EQUIPMENT complied with 16 2 d second dash provided and 16 9 2 8 11 3 1 MAINS PLUG not fitted with more than one POWER Power supply cord not part N A SUPPLY CORD of the investigation relevant to desk top power supply unit 8 11 3 2 POWER SUPPLY CORDS are no less robust than See appended Table 8 10 ordinary tough rubber sheathed flexible cord IEC 60245 1 2003 Annex A designation 53 or
232. rovided by the manufacturer 7 9 2 4 RM RESULTS TABLE Electrical power source N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 Supplementary Information No additional power source incorporated Mains operated equipment 7 9 3 2 RM RESULTS TABLE Replacement of fuses power supply cords other N A parts Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 TRF No IEC60601_1G SI Page 139 of 279 Report No T223 0330 12 7 9 3 2 RM RESULTS TABLE Replacement of fuses power supply cords other N A parts Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 6 3 6 4 6 5 Supplementary Information EUT is not permanently installed equipment 8 1 b 1 RM RESULTS TABLE Fundamental rule of protection against electric shock N A interruption of any one power carrying conductor Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 Supplementary Information No conductor between ME equipment parts and separate enclosures 8 1 b 2 RM RESULTS TABLE Fundamental rule of protection against electric shock N A unint
233. rs with Class or Class Il construction intended for supplying end medical product by its output voltage Power is delivered to the medical device via secondary SELV wire with the DC plug at the end or via secondary connector See enclosed pictures of the unit for details The equipment has been evaluated for use in a Pollution Degree 2 and over voltage category Il environment and a maximum altitude of 2000 m The transformer provides reinforced insulation These transformers are built up to fulfils the requirement of insulation class B 130 C and provide in addition an UR OBJY2 insulation system see also list of safety critical components The product is shipped without manual as required for a medical end product The manual has to be part of the end medical product only technical specifications and safety instructions provided by the manufacturer The product was evaluated for a maximum ambient of 40 C EUT is intended for indoor use only The top enclosure is secured to bottom enclosure by ultrasonic welding desk top version Other versions provided without external enclosure The power supply is provided without power on indicator End product consideration The power supply in maintenance free The power supply is intended for operating at ambient temperature up to 40 C The unit shall not be used for use in an oxygen rich environment The unit it is not intended to be use with flammable anaesthetics and not intended
234. rupted the less favourable of the two TRF No IEC60601_1G SI gt Page 198 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark N A 13 2 6 Leakage of liquid RISK MANAGEMENT FILE examined to determine the appropriate test conditions sealed rechargeable batteries exempted N A 13 2 7 Impairment of cooling that could result in a HAZARD using test method of 11 1 Single ventilation fans locked consecutively N A Ventilation openings on top and sides impaired N A by covering openings on top of ENCLOSURE or positioning of ME EQUIPMENT against walls Simulated blocking of filters N A Flow of a cooling agent interrupted N A N A 13 2 8 Locking of moving parts Only one part locked at a time Also see 13 2 10 below N A 13 2 9 Interruption and short circuiting of motor capacitors Motor capacitors short amp open circuited Also see 13 10 N A 13 2 10 Additional test criteria for motor operated ME EQUIPMENT in 13 2 8 amp 13 2 9 For every test in SINGLE FAULT CONDITION of 13 2 8 N A and 13 2 9 motor operated EQUIPMENT stared from COLD CONDITION at RATED voltage or at the upper limit of RATED voltage range for specified time Temperatures of windings determined at the end N A of specified test periods or at the instant of operation of fuses THERMAL CUT OUTS motor protective dev
235. s Class l i Page 227 of 279 Report No T223 0330 12 Encl No 2 ii a it aii Ma lll 2 Lwil Report No T223 0330 12 Encl No 2 Page 228 of 279 2 Page 229 of 279 Report No T223 0330 12 Encl No 2 e5e2e 8ea MN i Page 230 of 279 Report No T223 0330 12 Encl No 2 GTM21089 series Class II i Page 231 of 279 Report No T223 0330 12 Encl No 2 TT a S E E Z A i Page 232 of 279 Report No T223 0330 12 Encl No 2 i Page 233 of 279 Report No T223 0330 12 Encl No 2 Page 234 of 279 Report No T223 0330 12 Encl No 2 GTM21096 series With 3 pin input connector 20111187 16 Page 235 of 279 Report No T223 0330 12 Encl No 2 Page 236 of 279 Report No T223 0330 12 Encl No 2
236. s optionally provided c Partially sealed oil filled ME EQUIPMENT and its parts provided with means for checking the oil level to detect leakage ME EQUIPMENT and technical description examined and manual tests conducted to confirm compliance with above requirements TRF No IEC60601_1G SIS Page 112 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark During tests windings did not open no HAZARDOUS SITUATION occurred and maximum temperatures of windings did not exceed values in Table 31 Dielectric strength test of 8 8 3 conducted on See appended Table 15 5 2 transformer after short circuit and overload TOSUS ie EEA T S TATE A TTT 5 Switch mode transformer incorporated within the equipment Dielectric strength test according to Clause 8 8 3 performed Transformer output winding short circuited See appended Table 15 5 1 2 and test continued until protective device operated or THERMAL STABILITY achieved Short circuit applied directly across output Short circuit performed on windings for transformers not tested according transformer output to 5X frequency and 5X voltage test of 15 5 2 windings Multiple overload tests conducted on windings See appended Table 15 5 1 3 with more than one protective device to evaluate worst case NORMAL USE loading and POCO CHION anairen erinan an eaaa aanak EERE Transformer windings provided with adequate Switch mode transformer insu
237. s with a design and test specification where Table 14 9 appropriate and descriptive data on design environment included in RISK MANAGEMENT FILE TRF No IEC60601_1G SI Page 103 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark A VERIFICATION plan containing the specified See Appended RM Results information used to verify and document Table 14 10 functions implementing BASIC SAFETY ESSENTIAL PERFORMANCE Or RISK CONTROL measures i milestone s when VERIFICATION is to be N A performed for each function selection and documentation of VERIFICATION N A strategies activities techniques and appropriate level of independence of the personnel performing the VERIFICATION 14 11 A PEMS VALIDATION plan containing validation of See Appended RM Results N A BASIC SAFETY amp ESSENTIAL PERFORMANCE and Table 14 11 requiring checks for unintended functioning of PEMS to perform and document PEMS VALIDATION The person with overall responsibility for PEMS VALIDATION is independent of design team and no member of a design team is responsible for PEMS VALIDATION of their own design All professional relationships of members of PEMS VALIDATION team with members of design team documented in RISK MANAGEMENT FILE providing methods amp results of PEMS VALIDATION 14 12 Continued validity of previous design documentation assessed under a documented modification change PROCEDURE other
238. ses CAN CSA Z9170 1 00 R2005 Terminal units for medical gas pipeline systems Part 1 Terminal units for use with compressed medical gases and vacuum CAN CSA Z9170 2 00 R2005 Terminal units for medical gas pipeline systems Part 2 Terminal units for anaesthetic gas scavenging systems CAN CSA Z9170 2 00 R2005 Terminal units for medical gas pipeline systems Part 2 Terminal units for anaesthetic gas scavenging systems CAN CSA Z15002 02 R2007 Flow metering devices for connection to terminal units of medical gas pipeline systems ASME International American Society of Mechanical Engineers PTC 25 2001 Pressure Relief Devices CGA Compressed Gas Association V 1 2005 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections V 5 2005 Diameter Index Safety System Non interchangeable Low Pressure Connections for Medical Gas Applications ISO International Organization for N A Standardization 32 1977 Gas cylinders for medical use Marking for identification of content 407 2004 Small medical gas cylinders Pin index yoke type valve connections ES SIS Page 218 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark any voltage above 750 V 1 050 V peak as No such high voltage within defined in the Canadian Electrical Code CEC the equipment Part a the applicable safety requirements of a Considered relevant CSA
239. shown by measurement or using test finger No such flexible cords provided Cord connected HAND HELD parts and cord connected foot operated control N A devices Control devices of ME EQUIPMENT and their EUT is not cord connected connection cords contain only conductors and hand held parts and cord components operating at 42 4 V peak a c max connected foot operated or 60 V d c in circuits isolated from MAINS PART control devices by two MEANS OF PROTECTION TRF No IEC60601_1G SI Page 65 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark d c limit of 60 V applied to d c with no more than 10 peak to peak ripple 42 4 V peak limit applied when ripple exceeded 10 peak to peak limit Connection and anchorage of a flexible cord to a HAND HELD or foot operated control device of ME EQUIPMENT at both ends of cable to control device complied with 8 11 3 when breaking free or shorting between conductors could result in a HAZARDOUS SITUATION This requirement applied to other HAND HELD parts when disturbance or breaking of one or more of connections could result in a HAZARDOUS SITUATION N A a Internal cables and wiring adequately See Appended RM Results protected against contact with a moving part or Table 8 10 5 from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION sceceeeeeceseeeeseeeesseeenseeeesenes No moving parts provid
240. ss Il Open frame PCB mounted version End product consideration Disconnecting device Desk top version Mains plug is considered as disconnecting device Open frame PCB mounted version end product consideration The transformer between primary and secondary circuit provides reinforced insulation This transformer is built up to fulfil the requirement of insulation class B See also list of safety critical components The equipment has been evaluated for use in a Pollution Degree 2 and overvoltage category Il environment and a maximum altitude of 2000 m TRF No IEC60601_1G SIS Page 13 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark INSULATION DIAGRAM without protective earth fv INSULATION DIAGRAM with protective earth 2 TRF No IEC60601_1G SI gt Page 14 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark TABLE To insulation diagram OP Pollution degree cccssecesesseeseeseeeeeeeees PD 2 Overvoltage category ceceeeeeeeeree OVC II ACU G no cased castes annaas aae aeaaaee anana Up to 2000 meters Additional details on parts considered gt lt None _ Areas as applied parts cccsscsessseeeeesseeeees See Clause 4 6 for details Area Number and CTI Working voltage Required Required Measured Measured Remarks type of Means IIIb creepage clearance creepage clearance of Protection i
241. ssible to prevent the devices from operating TRF No IEC60601_1G SIS Page 48 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Worst case voltage between pins of plug and See appended Table 8 4 3 between either supply pin and ENCLOSURE did not exceed 60 V one s after disconnecting the plug of ME EQUIPMENT or its parts V sasssa A triggering circuit used to ensure Considered disconnection occurred at peak of supply voltage waveform When voltage exceeded 60 V calculated or See appended Table 8 4 3 N A measured stored charge didn t exceed 45 uC N A 8 4 4 Residual voltage of conductive parts of See appended Table 8 4 4 capacitive circuits having become accessible after ME EQUIPMENT was de energized after removal of ACCESS COVERS didn t exceed 60V or calculated stored charge didn t exceed 45yC A device manually discharging capacitors used when automatic discharging was not possible and ACCESS COVERS could be removed only with aid of a TOOL Capacitor s and connected circuitry marked with symbol 24 of Table D 1 IEC 60417 5036 DB 2002 10 and manual discharging device specified in technical description Separation of parts 8 5 1 1 Two MEANS of PROTECTION provided for ME 2 x MOOP provided between EQUIPMENT to prevent APPLIED and other primary and accessible ACCESSIBLE PARTS from exceeding limits in 8 4 plastic parts desk top version and between primary and secondar
242. ssociated with infrared radiation other than N A emitted by lasers and LEDS Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 10 7 RM RESULTS TABLE RISK associated with ultraviolet radiation other than N A emitted by lasers and LEDS Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information TRF No IEC60601_1G SI gt Page 180 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark TABLE Thermal requirements OP Fewer o a a E Jamin a o Maximum measured temperature T of Max measured temperature C Allowe part at d Tmax C Model GTM21089 1305 Output load 5 0 Vdc 2 6 A 1 PCB near D4 2 Optical insulator U1 3 Capacitor C9 4 T1 winding 5 T1 core 6 PCB near to Q2 7 PCB near to Q3 8 Capacitor C2 9 PCB near to D8 10 Inductor LF1 11 Case top 12 Case bottom 13 PCB 14 Inside enclosure Input current A Output voltage Vdc Output current A Duration min 84 8 80 8 78 1 80 5 78 1 75 2 77 5 80 1 78 8 71 5 69 0 71 0 95 1 90 7 89 8 93 1 88 9 84 9 84 3 87 2 8
243. strength TRF No IEC60601_1G SIS Page 126 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Dielectric strength test of Clause 8 8 3 for the appropriate type and number of MmoP s conducted by preparing the sample according to IEC 60851 5 1996 Clause 4 4 1 for a twisted pair with test voltages at least twice Tables 6 amp 7 but not less than below with no breakdown 3000 V for BASIC and SUPPLEMENTARY INSULATION V csscecesseessseeesseeesseeessaeeesseeesseeeeseaees 6000 V for REINFORCED INSULATION V Flexibility and adherence ma Sample subjected to flexibility and adherence test 8 of IEC 60851 3 1996 clause 5 1 1 using mandrel diameters of Table L 1 Sample examined according to IEC 60851 3 1997 clause 5 1 1 4 followed by dielectric test of clause 8 8 3 except test voltage applied between wire and mandrel with no breakdown Test voltage was at least the voltage in Tables 6 and 7but not less than the following 1500 V for BASIC and SUPPLEMENTARY INSULATION V ssesesesessersseecesessssseaeanseeeeeseeaestensess 3000 V for REINFORCED INSULATION V 000 mandrel calculated from the wire diameter equivalent to 118 Mpa 11 8 Mpa 5 i Sample subjected to heat shock test 9 of IEC 60851 6 1996 followed by dielectric strength test of clause 8 8 3 except test voltage applied between the wire and mandrel Test voltage was
244. sults or minimizing the associated RISK described in Table 7 2 13 instructions FOF USC ccceeceeseeeeseeeeeeeeseeeeeeeeees HIGH VOLTAGE TERMINAL DEVICES on the outside of No such terminals provided ME EQUIPMENT accessible without the use of a TOOL marked with symbol 24 of Table D 1 symbol IEC 60417 5036 DB 2002 10 Requirements for cooling provisions marked Not provided N A e g supply Of Water or AIP eeeseeseeeeeeeeenseeneees 7 2 16 ME EQUIPMENT with limited mechanical stability ae ee Packaging marked with special handling EUT is not special handling instructions for transport and or storage equipment Permissible environmental conditions for transport and storage marked on outside of PACKAGING Aerius eia aeaaeae eiai RATED maximum supply pressure from an external source marked on ME EQUIPMENT adjacent to each input connector eee TRF No IEC60601_1G SI Page 35 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Symbol 7 of Table D 1 IEC 60417 5017 No functional earth terminal DB 2002 10 marked on FUNCTIONAL EARTH provided TERMINAL Only protective earth provided for models with protective earth Protective means required to be removed to use a particular function of ME EQUIPMENT with alternate applications marked to indicate the necessity for replacement when the function is no longer needed N A N A A marking referring
245. sure no cracks Not relevant for open frame and PCB mounted version TRF No IEC60601_1G SIS Page 202 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 15 3 3 Impact Test Steel ball 50 mm in dia 500g 25 Test performed all sides of the g falling from a 1 3 m enclosure No damage of the enclosure no cracks Not relevant for open frame and PCB mounted version 15 3 4 2 Drop Test portable Drop height 5 cm No damage of the enclosure no equipment cracks Test performed on desk top version Not relevant for open frame and PCB mounted version 15 3 6 Mould Stress Relief 7 h in oven at temperature C Whole equipment placed into 96 C the circulating air oven for 7 hours Maximum temperature measured on the outer enclosure during normal use of the equipment 85 5 C No damage of the enclosure Not relevant for open frame and PCB mounted version Supplementary information DAs applicable Push Impact Drop Mould Stress Relief and Rough Handling Tests delete not applicable rows 15 3 2 RM RESULTS TABLE Push test N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary information No damage of the enclosure after push test 15 3 3 RM RESULTS TABLE Impact test N A Clause of Document Ref in RMF Result
246. t Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 10 2 RM RESULTS TABLE Alpha beta gamma neutron amp other particle radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 TRF No IEC60601_1G SIS Page 178 of 279 Report No T223 0330 12 10 2 RM RESULTS TABLE Alpha beta gamma neutron amp other particle radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 Supplementary information 10 3 RM RESULTS TABLE Microwave radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information 10 5 RM RESULTS TABLE Other visible electromagnetic radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary information TRF No IEC60601_1G SI gt Page 179 of 279 Report No T223 0330 12 10 6 RM RESULTS TABLE Risk a
247. t between current achieved output minus and 5808 output plus Output voltage 22 90 Vdc Measured 23 54 Vdc 42 4VA Maximum output between current achieved R12 output shorted minus and output plus TSCA Output voltage 23 38 Vdc Supplementary Information 1 The input supply voltage to the ME EQUIPMENT shall be the RATED voltage or the voltage within the RATED voltage range which results in the highest measured value See clause 8 5 4 2 If the d c peak to peak ripple gt 10 waveform considered as a c See clause 8 4 2 2 Output voltage during single fault conditions was recorded Output voltage was below SELV limit See table 13 2 TABLE single fault conditions in accordance with 13 2 2 to 13 2 13 inclusive In additional evaluation of voltage limiting components in SELV circuits performed See table evaluation of voltage limiting components in SELV circuits The energy on the output did not exceed 240 VA 8 4 2 c RM RESULTS TABLE Accessible parts including applied parts N A TRF No IEC60601_1G SI gt Page 142 of 279 Report No T223 0330 12 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary Information 8 4 3 TABLE ME EQUIPMENT for connection to a power source by a plug P measurement of voltage or calculation of stored charge 1 s afte
248. t result ina HAZARDOUS SITUATION other than interruption of its intended function TRF No IEC60601_1G SIS Page 116 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark ME SYSTEM connections and wiring ie Incorrect connection of accessible connectors See Appended RM Results removable without a TOOL prevented where a Table 16 9 1 HAZARDOUS SITUATION could otherwise exist Plugs for connection of PATIENT leads could not be connected to other outlets of the same ME SYSTEM likely to be located in PATIENT ENVIRONMENT except when examination of connectors and interchanging them proved no HAZARDOUS SITUATION could result 16 9 2 MAINS PARTS components and layout Se ee 16 9 2 1 a MULTIPLE SOCKET OUTLET only allows N A connection using a TOOL or MULTIPLE SOCKET OUTLET is of a type that N A cannot accept MAINS PLUGS of any of the kinds specified in IEC TR 60083 or MULTIPLE SOCKET OUTLET is supplied via a N A separating transformer b MULTIPLE SOCKET OUTLET marked with safety N A sign 2 of Table D 2 i e safety sign ISO 7010 W001 visible in NORMAL USE and marked either individually or in combinations N A with the maximum allowed continuous output in amperes or volt amperes or marked to indicate the equipment or N A equipment parts it may safely be attached to c MULTIPLE SOCKET OUTLET complied with IEC N A 60884 1 and the following requirements CREEPAGE and
249. ted within the power supply unit b THERMAL CUT OUTS with a safety function to See Appended RM Results be reset by a soldering operation affecting Table 15 4 2 1 b operating value not fitted in ME EQUIPMENT as verified by examination of design and RISK MANAGEMENT FILE eccceeseeeeeeeeeeseeesseeeeeneeeneneeeesnes No such component used c An independent non SELF RESETTING THERMAL See Appended RM Results CUT OUT is additionally provided where a Table 15 4 2 1 c failure of a THERMOSTAT could constitute a HAZARD as verified by examination of design and RISK MANAGEMENT FILE 2 0ccceeceseeseeseeeeeeees No thermostat provided d Based on design and RISK MANAGEMENT FILE See Appended RM Results review loss of function of ME EQUIPMENT due to Table 15 4 2 1 d operation of THERMAL CUT OUT or OVER CURRENT RELEASE doesn t result in a HAZARDOUS SITUATION EUT Is not end medical product The risk management requirements of the standard were not addressed Shall be evaluated during end medical product approval TRF No IEC60601_1G SIS Page 108 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark e Capacitors or other spark suppression devices not connected between contacts of THERMAL CUT OUTS f Use of THERMAL CUT OUTS or OVER CURRENT End product consideration RELEASES do not affect safety of ME EQUIPMENT as verified by following tests Positive temperature coeffici
250. ting other parts N A considered MEANS OF OPERATOR PROTECTION Separation of PATIENT CONNECTIONS N A PATIENT CONNECTIONS of F TYPE APPLIED PART See appended Table 8 7 N A separated from all other parts by equivalent to one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to maximum MAINS VOLTAGE and No patient connections complied with limit for PATIENT LEAKAGE provided CURRENT at 110 of max MAINS VOLTAGE No applied parts provided Separation requirement not applied between multiple functions of a single F TYPE APPLIED PART PATIENT CONNECTIONS treated as one APPLIED PART in the absence of electrical separation between PATIENT CONNECTIONS of same or another function MANUFACTURER has defined if multiple functions are to be considered as all within one APPLIED PART or as multiple APPLIED PARTS TRF No IEC60601_1G SI Page 51 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Classification as TYPE BF CF or DEFIBRILLATION N A PROOF applied to one entire APPLIED PART o LEAKAGE CURRENT tests conducted per 8 7 4 See appended Table 8 7 Dielectric strength test conducted per 8 8 3 See appended Table 8 8 3 CREEPAGE and CLEARANCES measured per 8 9 and Tables 11 to 16 as applicable A protective device connected between PATIENT CONNECTIONS of an F TYPE APPLIED PART and ENCLOSURE to protect against excessive voltages did not operate below 500 V r m
251. tion MOOP Solid insulation forming a MEANS OF PATIENT PROTECTION complied with dielectric strength test of Clause 8 8 at test voltage of Table 6 CREEPAGE and CLEARANCES forming a MEANS OF PATIENT PROTECTION complied with Table 12 PROTECTIVE EARTH CONNECTIONS forming a MEANS OF PATIENT PROTECTION complied with CI 8 6 E A Y1 capacitor complying with IEC 60384 14 See Appended Tables 8 8 3 and having passed dielectric strength test for and 8 10 two MEANS OF PATIENT PROTECTION considered equivalent to one MEANS OF PATIENT PROTECTION Two capacitors used in series each RATED for total WORKING VOLTAGE across the pair and have the same NOMINAL capacitance Voltage Total Working V and C Nominal uF ATAT 8 5 1 3 MEANS OF OPERATOR PROTECTION MOOP eo O P Ee Solid insulation forming a MEANS OF OPERATOR PROTECTION complied with dielectric strength test of 8 8 at test voltage of Table 6 or requirements of IEC 60950 1 for INSULATION N A CO ORDINATION CREEPAGE and CLEARANCES forming a MEANS OF OPERATOR PROTECTION complied with limits of Tables 13 to 16 inclusive or eo eee requirements of IEC 60950 1 for INSULATION N A CO ORDINATION PROTECTIVE EARTH CONNECTIONS forming a MEANS OF OPERATOR PROTECTION complied with CI 8 6 or requirements and tests of IEC 60950 1 for See Attachment N A protective earthing ccceeeceesseeeesseteeeeeeeenees TRF No IEC60601_1G SIS Page 50 of 27
252. tion in NORMAL USE and a mass 2 x 135 kg or twice intended person s load the greater used applied to foot rest over an area of 0 1 m for 1 min Kg Damage or deflection resulting in an unacceptable RISK did not occur on foot rest and its secured joints b Deflection of a support surface from PATIENT See Appended RM Results or OPERATOR loading on an area of support Table 9 8 3 2 b suspension where a PATIENT or OPERATOR can sit did not result in an unacceptable Risk Compliance confirmed by examination of ME See appended Table 8 10 EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and by a test PATIENT Support suspension system set in See appended Table 9 8 3 2 most unfavourable NORMAL USE position and a mass of 60 of part of SAFE WORKING LOAD simulating PATIENT or OPERATOR or a min 80 kg placed on support or suspension system with centre of load 60 mm from outer edge of support or suspension system for at least one minute Kg Dynamic forces that can be exerted on equipment parts supporting or suspending a PATIENT Or OPERATOR in NORMAL USE did not result in an unacceptable RISK as confirmed by following test TRF No IEC60601_1G SI gt Page 84 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark PATIENT support suspension system set in See appended Table 9 8 3 3 most unfavourable NORMAL USE position and a mass equal to SAFE WORKING LO
253. tive exposure time dBA 140 dB un weighted sound pressure level for impulsive or impact acoustic energy dB RISK MANAGEMENT FILE examined for RISKS See Appended RM Results associated with infrasound or ultrasound Table 9 6 2 2 when present addressed in RISK MANAGEMENT PROCESS Hand transmitted vibration Means provided except for INTENDED USE N A vibrations to protect PATIENT and OPERATOR when hand transmitted frequency weighted r m s acceleration generated in NORMAL USE exceeds specified values measured at points of hand contact with PATIENT or OPERATOR 2 5 mis for a cumulative time of 8 h during a N A 24 h period m s Accelerations for different times inversely N A proportional to square root of time m s Pressure vessels and parts subject to pneumatic and hydraulic pressure Requirements of this clause applied to vessels No pressure vessels or parts N A and parts of ME EQUIPMENT Subject to pressure subject to pressure provided resulting in rupture and unacceptable RISK Parts of a pneumatic or hydraulic system used as a support system comply with 9 8 Pneumatic and hydraulic parts of ME See Appended RM Results EQUIPMENT or ACCESSORIES met following Table 9 7 2 requirements based on examination of RISK MANAGEMENT FILE No pneumatic and hydraulic parts within the equipment No unacceptable Risk resulted from loss of pressure or loss of vacuum No unacceptable Risk resulted fro
254. to ACCOMPANYING DOCUMENTS provided for heating elements or lamp holders designed for heating lamps that can be changed only by SERVICE PERSONNEL using a TOOL Type of battery and mode of insertion when applicable is marked ccccessesseereeeeeeeeeees H An identifying marking provided referring to instructions in ACCOMPANYING DOCUMENTS for batteries intended to be changed only by SERVICE PERSONNEL using a TOOL A warning provided indicating replacement of lithium batteries or fuel cells when incorrect replacement by inadequately trained personnel would result in an unacceptable RISK e g excessive temperatures fire or explosion An identifying marking also provided referring See Appended RM Results N A to instructions in ACCOMPANYING DOCUMENTS _ Table 7 3 3 TRF No IEC60601_1G SI gt Page 36 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Fuses replaceable THERMAL CUT OUTS and OVER Both enclosure parts are CURRENT RELEASES accessible by use of a TOOL fixed together by means of marked by type and full rating at the component ultrasonic welding or by reference to ACCOMPANYING DOCUMENTS therefore primary fuses are not accessible by the operator Otherwise type and rating specified on the PCB near fuses F1 T1A 250V F2 T1A 250V End product consideration for open frame and PCB mounted power supply unit F1 T1A 250V F2 T1A 250V F1 T1A 250
255. tor V Hz A cos GTM21089 1305 desk top version output 5 0 Vdc 2 6 A Rated output load 90 50 60 0 366 0 366 18 1 18 0 po Operating Conditions Ratings Rated output load 120 50 60 0 284 0 280 17 5175 TRF No IEC60601_1G SI gt Page 132 of 279 Report No T223 0330 12 IEC 60601 1 Rated output load 50 60 Rated output load 50 60 0 174 0 173 17 9 17 8 Rated output load 50 60 0 161 0 162 18 0 18 1 GTM21089 1824 Desk top version output 24 0 Vdc 0 75 A 0 223 0 220 22 4122 3 0 216 0 215 22 6 22 5 GTM21089 1848 Desk top version output 48 0 Vdc 0 39 A EE Ea 0 177 0 176 17 8 17 8 50 60 Rated output load 220 Rated output load 230 50 60 50 60 50 60 Rated output load 50 60 0 222 0 221 24 1 24 1 Rated output load 0 211 0 211 24 6 24 5 50 60 TRF No IEC60601_1G SI gt Page 133 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark Power factor Supplementary Information Rated input voltage 100 240 Vac Rated input frequency 50 60 Hz Rated input current 500 250 mA Power input measurement performed on desk top version to represent others 5 1 RM RESULTS TABLE Type Tests N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Supplementary Information 5 4 a RM RESULTS TABLE
256. tor in additional to protective earth Unacceptable risk would occur in case of MOOP isolation break down or degradation 4 3 RM RESULTS TABLE Essential Performance N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Supplementary Information The risk management requirements of the standard were not addressed 4 5 RM RESULTS TABLE Equivalent Safety for ME Equipment of ME System N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information The risk management requirements of the standard were not addressed TRF No IEC60601_1G SI Page 130 of 279 Report No T223 0330 12 4 6 RM RESULTS TABLE ME Equipment or system parts contacting the patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Supplementary Information No parts that can come into contact with the patient No applied parts provided 4 7 RM RESULTS TABLE Single Fault Condition for ME Equipment N E Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4
257. ts of CSA C22 2 No 42 CSA C22 2 No 49 and the following requirements The separating transformer shall comply with the requirements of CAN CSA E61558 2 1 with a rated output not exceeding 1 kVA for single phase transformers and 5 kVA for polyphase transformers The separating transformer shall also have a degree of protection not exceeding IPX4 SWITZERLAND NATIONAL DIFFERENCES to IEC 60601 1 Third edition National standard SN EN 60601 1 06 Ordinance on environmentally hazardous No mercury used during substances SR 814 081 Annex 1 7 normal use of the equipment Mercury Annex 1 7 of SR 814 81 applies for mercury SLE Page 222 of 279 Report No T223 0330 12 Encl No 1 National Differences Requirement Test Result Remark Switches containing mercury such as No such switched provided thermostats relays and level controllers are not Ordinance on chemical hazardous risk reduction SR 814 81 Annex 2 15 Batteries Annex 2 15 of SR 814 81 applies for batteries No batteries incorporated containing cadmium and mercury Note Ordinance relating to environmentally hazardous substances SR 814 013 of 1986 06 09 is not longer in force and superseded by SR 814 81 of 2009 02 01 ChemRRV Supply cords of portable electrical appliances Power supply cord was not having a rated current not exceeding 10 A shall part of the investigation be provided with a plug complying with IEC 60884 1 3 ed am
258. uA NC Leakage Current with all AP of same _ S 100uUA SFC d c current type connected together with 500 uA NC 1000 uA SFC a c external voltage on SIP SOP g Type CF AP 50 uA NC 100 uA SFC d c or a c current Maximum allowed values Fig 16 and 20 Total Patient Leakage Current with all AP of same Type B NA type connected together with Type BF 5000uA external voltage on F type AP Type CF 100 uA Fig 18 and 20 Total Patient Leakage Current with all AP of same type Maximum allowed valies connected together with external voltage Type B amp BF 1000 uA on metal Accessible Part not Protectively f Earthed Type CF N A TRF No IEC60601_1G SIS Page 150 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Note 1 For EARTH LEAKAGE CURRENT see 8 7 3 d and 8 7 4 5 Note 2 For TOUCH CURRENT see 8 7 3 c and 8 7 4 6 Note 3 For PATIENT LEAKAGE CURRENT SEE 8 7 3 b and 8 7 4 7 Note 4 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS of the same type See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values Note 5 In addition to conditions indicated in the Table tests conducted at operating temperature and after humidity preconditioning of 5 7 EQUIPMENT energized in stand by condition and fully operating max rated supply frequency at 110 o
259. uirement Test Result Remark 15 4 7 Cord connected HAND HELD and foot operated control devices a HAND HELD control devices of ME EQUIPMENT EUT is not cord connected complied with 15 3 4 1 hand held or foot operated control device b Foot operated control device supported an actuating force of 1350 N for 1 min applied over an area of 30 mm diameter in its position of NORMAL USE with no damage to device causing an unacceptable RISK ccccessesseeneeeeeeeeees Control device of HAND HELD and foot operated control devices turned in all possible abnormal positions and placed on a flat surface No unacceptable Risk caused by changing control setting when accidentally placed in an abnormal position a Foot operated control device is at least IPX1 amp complies with tests of IEC 60529 IP Code b ENCLOSURE of foot operated control devices See appended Table 11 6 containing electrical circuits is at least IPX6 and RM Results Table and complies with IEC 60529 if in NORMAL USE 15 4 7 3 b liquids are likely to be found IP Code i Probability of occurrence estimated as part of RISK MANAGEMENT PROCESS Aluminum wires less than 16 mm in cross Aluminium wires not used sectional area are not used a Oil container in PORTABLE ME EQUIPMENT allows for expansion of oil and is adequately sealed to prevent loss of oil in any position A pressure release device operating during NORMAL USE
260. ult Remark 7 Short circuit of U1 shorted secondary pins Output voltage increased to No Supply voltage 264 Vac aes bg andien droppen Model GTM21089 1948 48 Vdc output No load After 2 min unit damaged No high temperature rises observed No fire no hazard 8 Short circuit of D8 Output voltage dropped to 0 No V immediately Supply voltage 264 Vac Model GTM21089 1824 24 Vdc output No hightemperature mses observed After removal of SC unit operated normally No fire no hazard 9 Short circuit of C3 Resistor R13 damaged No Supply voltage 264 Vac No changes of the output Model GTM21089 1824 24 Vdc output voltage andicument No high temperature rises observed No fire no hazard 10 Transformer T1 Pin 6 to Pin 8 Output voltage dropped to 0 No Vdc No high temperature rises were observed Supply voltage 264 Vac Model GTM21089 1824 24 Vdc output No fire no hazard 11 Output short circuit Output voltage dropped to 0 No Supply voltage 264 Vac Viramediately Model GTM21089 1948 48 Vdc output Om parcurrant inctonsed to 1 28 A After 1 minute primary fuse opened No fire no hazard TRF No IEC60601_1G SI Page 197 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 12 Output overload Input current 0 381 A No Supply voltage 90 Vac Output current 2 93 A Model GTM21089 1305 Maximum temperature o
261. upplementary Information No batteries inside Mains operated equipment 7 3 7 RM RESULTS TABLE Supply terminals N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 Supplementary Information No such terminals provided 7 4 2 RM RESULTS TABLE Control devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 Supplementary Information No control devices provided 7 5 RM RESULTS TABLE Safety signs N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 TRF No IEC60601_1G SI gt Page 138 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 7 5 RM RESULTS TABLE Safety signs N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 Supplementary Information No safety signs provided 7 9 1 RM RESULTS TABLE General accompanying documents See Table C 4 N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 Supplementary Information Paper version of accompanying documents p
262. voltages under N A or d c Table 15 not applied since all the normal use of the following conditions were met equipment CLEARANCE was at least 5 mm insulation complied with dielectric strength test of 8 8 3 using an a c test voltage with an r m s value equal to 1 06 times PEAK WORKING VOLTAGE or a d c test voltage equal to peak value of a c test voltage with an r m s value equal to 1 06 times PEAK WORKING VOLTAGE and CLEARANCE path was partly or entirely through air or along the surface of an insulating material of material group 8 9 1 14 Minimum CREEPAGE DISTANCES for two MEANS OF Considered OPERATOR PROTECTION obtained by doubling values in Table 16 for one MEANS OF OPERATOR PROTECTION Dielectric strength test conducted only across part s of the path that are through air when CLEARANCE path was also partly along surface of a non group material DEFIBRILLATION PROOF APPLIED PARTS are 4 mm or more to meet 8 5 5 1 a Short circuiting of each single one of See appended Table 8 9 2 CREEPAGE DISTANCES and CLEARANCES in turn did Sufficient d not result in a HAZARDOUS SITUATION for ie telen deteee an insulation in MAINS PART between parts of c earance distances opposite polarity therefore min CREEPAGE and provided PatWeBn parts of CLEARANCES not applied c seecceeeeeeeeseeeeee opposite polarity before mains fuses Short circuit performed after primary fuses No hazardous situation
263. with protective earth humidity treatment Single fault condition supply 264 60 138 3 Measured on desk top interruption reverse polarity before version with protective earth humidity treatment Model GTM21096 series Normal condition normal polarity 264 60 84 4 Measured on open frame before humidity treatment version with protective earth Normal condition reverse polarity 264 60 84 0 Measured on open frame before humidity treatment version with protective earth Single fault condition supply 264 60 123 5 Measured on open frame interruption normal polarity before version with protective earth humidity treatment Single fault condition supply 264 60 123 2 Measured on open frame interruption reverse polarity before humidity treatment version with protective earth TRF No IEC60601_1G SLE Page 147 of 279 IEC 60601 1 Report No T223 0330 12 Requirement Test Result Remark Model GTM21089 series Normal condition normal polarity 264 60 96 8 Measured on desk top after humidity treatment version with protective earth Normal condition reverse polarity 264 60 95 9 Measured on desk top after humidity treatment version with protective earth Single fault condition supply 264 60 141 0 Measured on desk top interruption normal polarity after version with protective earth humidity treatment Single fault condition supply
264. ximum allowed Maximum Ambient Winding tested insulation used fuse circuit temp from winding temp ee A B E F H breaker Ratings Table 31 C measured C Model GTM21089 1305 Supply voltage 90 Vac T1 Pin 6 to Pin Class B Primary fuse 165 105 4 39 8 9 output overload Model GTM21089 1305 Supply voltage 264 Vac T1 Pin 6 to Pin Class B Primary fuse 165 138 1 39 8 9 output overload Model GTM21089 1824 Supply voltage 90 Vac T1 Pin 6 to Pin Class B Primary fuse 165 107 6 39 8 9 output overload Model GTM21089 1948 Supply voltage 90 Vac TRF No IEC60601_1G SI Page 209 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark T1 Pin 6 to Pin Class B Primary fuse 165 122 4 39 9 9 output overload Model GTM21089 1948 Supply voltage 264 Vac T1 Pin 6 to Pin Class B Primary fuse 165 164 4 39 8 9 output overload Supplementary information Loads on other windings between no load and their NORMAL USE load Time durations IEC 60127 1 fuse 30 min at current from Table 32 Non IEC 60127 1 fuse 30 min at the current based on characteristics supplied by fuse manufacturer specifically 30 min clearing time current When no 30 min clearing time current data available test current from Table 32 used until THERMAL STABILITY achieved Other types of protective devices until THERMAL STABILITY achieved at a current just below minimum current oper
265. y circuit within the equipment desk top open frame and PCB mounted version 1 x MOOP provided between primary and protective earth within the equipment Each MEANS OF PROTECTION categorized as a Protection categorized as MEANS OF PATIENT PROTECTION or a MEANS OF operator protection OPERATOR PROTECTION taking into account Clause 4 6 and flow chart in Fig A 12 Varnishing enameling oxidation and similar N A protective finishes and coatings with sealing compounds replasticizing at temperatures expected during operation and sterilization disregarded as MEANS OF PROTECTION Coatings and other insulation intended as a Considered MEANS OF PROTECTION complying with IEC 60950 1 2001 considered acceptable as a MEANS OF OPERATOR PROTECTION but not automatically as a MEANS OF PATIENT PROTECTION TRF No IEC60601_1G SI Page 49 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark RISK MANAGEMENT PROCESS taken into No applied parts provided N A consideration for MEANS OF PATIENT PROTECTION EUT is power supply unit Components and wiring forming a MEANS OF PROTECTION comply with 8 10 Insulation CREEPAGE CLEARANCES components Considered or earth connections not complying with 8 5 1 2 and 8 5 1 3 not considered as MEANS OF PROTECTION and failure of these parts regarded as NORMAL CONDITION 8 5 1 2 MEANS OF PATIENT PROTECTION MOPP Protection categorized as means of operator protec
266. y placed to enable ME EQUIPMENT or its part to be carried by two or more persons and by examination of EQUIPMENT its part or ACCOMPANYING DOCUMENTS b PORTABLE ME EQUIPMENT with a mass gt 20 kg provided with one or more carrying handles suitably placed to enable carrying by two or more persons as confirmed by actual carrying c Carrying handles and grips and their means See Appended Table 9 4 4 N A of attachment withstood loading test Expelled parts HAZARD N A Suitability of means of protecting against See Appended RM Results N A unacceptable RISK of expelled parts Table 9 5 1 determined by assessment and examination of RISK MANAGEMENT FILE sssssssnssunnnnnnnnnnnnnnnnnnnnnnnnnn FE No expelled parts can occur Cathode ray tube s complied with IEC 60065 2001 Clause 18 or IEC 61965 Human exposure to acoustic energy and See Appended RM Results vibration from ME EQUIPMENT doesn t resultin Table 9 6 1 unacceptable RISK as confirmed in RISK MANAGEMENT FILE including audibility of auditory alarm signals PATIENT sensitivity and tests of 9 6 2 and 9 6 3 2 cccceceeeeeeeeeeeeeeeeeeeeeee EUT not produces acoustic energy or vibration in NORMAL USE except for auditory alarm TRF No IEC60601_1G SI Page 79 of 279 Report No T223 0330 12 IEC 60601 1 Requirement Test Result Remark 80 dBA for a cumulative exposure of 24 h over a 24 h period dBA 83 dBA when halving the cumula

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