~~\: ..\'0/7 \87 q; u~j 'l( ref. certif. no. us- tuvr-4428 cb test certificate product produit name and address of the applicant nom et adresse du demandeur name and address of the manufacturer nom et adresse du fabricant name and address of the factory nom et adresse de l'usine note: when more than one factory, please report on page 2 note: lorsque it y plus d'une usine, veuillez utiliser la 2'= page trademark (if any) marque de fabrique (si elle existe) ratings and principal characteristics valeurs nominales et caracteristiques principales model/type ref. ref. de type additional information (if necessary, may also be reported on page 2) les informations complementaires (si necessaire, peuvent etre indiques sur la 2'm' page) a sample of the product was tested and found to be in conformity with un echantillon de ce produit a ete essaye et a ete considere conforme a la as shown in the test report ref. no. which forms part of this certificate comme indique dans ie rapport d'essais numero de reference qui constitue partie de ce certificat this cb test certificate is issued by the national certification body ce certificat d'essai oc est etabli par l'organisme natioinal de certification issued 2003-05
~ r;:::::~ r--", w rfj i '!; :~) 0u- ref. certif. no. us- tuvr-4428 tuvrheinland1 july 10, 2008 page 2 of 2 signature: date: issued 2003.05
issue date: 2008-05-16 page 1 of 2 report reference # e145177-a9-ul-1 correction 1 2009-04-10 copyright ? 2009 cover page for test report product category: power supplies, medical and dental product category ccn: qqhm2, qqhm8 test procedure: component recognition product: component power supply model/type reference: mw155raxyfz, where x represents the output voltage which may be the number 12, 15, 18 or 24; y indicates the output con nector style which may be any number from 00-99; f indicates the c14 type ac inle t; and z represents non-safety related customer options which may be an y number from 00-99. rating(s): input: 100-240 v~, 50-60 hz, 2.0-1.0 a output: mw155ra12yfz: 12 v dc/8.33 (100-110 v~); 12 v dc/9. 165 a (>110-240 v~) mw155ra15yfz: 15 v dc/7.33 a mw155ra18yfz: 18 v dc/6.66 a mw155ra24yfz: 24 v dc/5.0 a standards: ul 60601-1, 1st edition, 2006-04-26 (medical electr ical equipment, part 1: general requirements for safety) can/csa-c22.2 no. 601.1-m90, 2005 (medical electric al equipment - part 1: general requirements for safety) applicant name and address: sl power electronics corp 6050 king st ventura ca 93003 united states this report includes the following parts, in additi on to this cover page: 1. specific technical criteria 2. clause verdicts
issue date: 2008-05-16 page 2 of 2 report reference # e145177-a9-ul-1 correction 1 2009-04-10 copyright ? 2009 this is to certify that representative samples of t he products covered by this test report have been i nvestigated in accordance with the above referenced standards. the products have been found to comply with the requirements covering the category and the products are judged to be eligible for follow- up service under the indicated test procedure. the manufacturer is authorized to use the ul mark on su ch products which comply with this test report and any other applicable requirements of underwriters labo rat ories inc. ('ul') in accordance with the follow-up service agreement. only those pr oducts which properly bear the ul mark are consider ed as being covered by ul's follow-up service under the indicated test procedur e. the applicant is authorized to reproduce the refere nced test report provided it is reproduced in its e ntirety. ul authorizes the applicant to reproduce the latest pages of the referenced test report consisting of the first page of the specific technical criteria through to the end of the conditions of ac ceptability. any information and documentation involving ul mark services are provided on behalf of underwriters la boratories inc. (ul) or any authorized licensee of ul. test report by: reviewed by: ahmad daoudi marc m. mouser engineering associate manager underwriters laboratories inc. underwriters laborat ories inc.
issue date: 2008-05-16 page 1 of 5 report reference # e145177-a9-ul-1 correction 1 2009-04-10 trf no.: iec60601_1c underwriters laboratories inc. specific technical criteria test report ul 60601-1 medical electrical equipment part 1: general requirements for safety report reference no ........................: e145177-a9-ul-1 compiled by .....................................: ahmad daoudi reviewed by ....................................: marc m. mouser date of issue ....................................: 2008-05-16 standards ......................................... : ul 60601-1, 1st edition, 2006-04-26 (medical electr ical equipment, part 1: general requirements for safety) can/csa-c22.2 no. 601.1-m90, 2005 (medical electric al equipment - part 1: general requirements for safety) test procedure .................................: component recognition non-standard test method ...............: n/a test item description .......................: component power supply trademark ........................................: model and/or type reference ............: mw155raxyfz, where x represents the output voltage which may be the number 12, 15, 18 or 24; y indicates the output connector style which may be any number from 00-99; f indicates the c14 type ac inlet; and z represents non-safety related customer options which may be any number from 00-99. rating(s) ......................................... ..: input: 100-240 v~, 50-60 hz, 2.0-1.0 a output: mw155ra12yfz: 12 v dc/8.33 (100-110 v~); 12 v dc/9. 165 a (>110-240 v~) mw155ra15yfz: 15 v dc/7.33 a mw155ra18yfz: 18 v dc/6.66 a mw155ra24yfz: 24 v dc/5.0 a
issue date: 2008-05-16 page 2 of 5 report reference # e145177-a9-ul-1 correction 1 2009-04-10 trf no.: iec60601_1c underwriters laboratories inc. general information test item particulars (see also clause 5): classification of installation and use ............ ............. : portable supply connection ................................. .................... : appliance coupler accessories and detachable parts included in the evaluation ........................................ .......................... : none options included .................................. ..................... : none possible test case verdicts: - test case does not apply to the test object ..... ........ : n / a - test object does meet the requirement ........... ........ : p(pass) - test object does not meet the requirement ....... ...... : f(fail) (acceptable only if a corresponding, less stringent national requirement is "pass") abbreviations used in the report: - normal condition ................................ ............ : n.c. - single fault condition ................ : s.f.c. - operational insulation .......................... ........... : op - basic insulation ........................ : bi - basic insulation between parts of opposite polarit y: bop - supplementary insulation ......... : si - double insulation ............................... ............. : di - reinforced insulation ................. : ri general remarks: - "(see enclosure #)" refers to additional informat ion appended to the test report - "(see appended table)" refers to a table appended to the test report - throughout the test report a point is used as the decimal separator general product information: ca1.0 report summary ca1.1 n/a cb1.0 product description cb1.1 the mw155raxyfz is used as a desktop and/or portabl e power supply. a green led is provided to indicate dc output is present. cc1.0 model differences cc1.1 the mw155raxyfz is class i unit, where x represents the output voltage which may be the number 12, 15, 18 or 24; y indicates the output con nector style which may be any number from 00-99; f indicates the c14 type ac inlet; and z rep resents non-safety related customer options which may be any number from 00-99. the transforme rs have different turns and gage but have similar construction.
issue date: 2008-05-16 page 3 of 5 report reference # e145177-a9-ul-1 correction 1 2009-04-10 trf no.: iec60601_1c underwriters laboratories inc. cd1.0 additional information cd1.1 the schematics are kept on file at the cb testing l aboratory mentioned in the first page of this test report, and can be provided by the applicant upon r equest by cbtls/ncbs. all tests were conducted at the smt facility. ce1.0 technical considerations ce1.1 the product was investigated to the following additional standards: ul 60601-1, 1st edition, 2006-04-26 (includes national differences for usa), can/csa-c22.2 no. 601.1-m90 (r2005) (includes national differences for canada), ul 60601-1, 1st edition, 2006-04-26 (includes national differences for usa) ce1.2 the product was not investigated to the following standards or clauses: clause 36, electromagnetic compatibility (iec 601-1-2), clause 48, biocompatibility (iso 10993-1), clause 52.1, programmable electronic systems (iec 601-1-4), ce1.3 the product is classified only to the followi ng hazards: casualty, fire , shock ce1.4 the degree of protection against harmful ingress of water is: ordinary ce1.5 the following accessories were investigated f or use with the product: , ce1.6 the mode of operation is: continuous ce1.7 software is relied upon for meeting safety requirements related to mechanical, fire and shock: no ce1.8 the product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide: no cf1.0 engineering conditions of acceptability cf1.1 for use only in or with complete equipment where th e acceptability of the combination is determined by underwriters laboratories inc. when installed in an end-product, consideration mus t be given to the following: cf2.0 this component has been judged on the basis of the required spacings in the first edition of the standards for medical electrical equipment, part 1: general requirements for safety, ul 60601-1, which covers the end use product for which the component is designed. -- cf2.1 the component is provided with a plastic enclosure and an appliance inlet --
issue date: 2008-05-16 page 4 of 5 report reference # e145177-a9-ul-1 correction 1 2009-04-10 trf no.: iec60601_1c underwriters laboratories inc. cf2.2 the output circuits have not been evaluated f or direct patient connection (type b, bf or cf). -- cf2.3 the temperature test was performed in an ambient of 25 c and were calculated for a raised ambient of 40c. in some instances, the temperature test was repeated in an ambient of 40c to validate the calculation. -- cf2.4 the power supply was evaluated as reinforced insulation between primary and secondary; basic insulation between primary to heatsink; and operational insulation between secondary to heatsink. -- cf2.5 this power supply has been evaluated as class i equipment, continuous operation, and has not been evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. -- cf2.6 the output has been evaluated and tested for operator accessible part. under normal and single fault conditions, the outputs do no t exceed 25 v ac or 60 v dc. -- cf2.7 the product was evaluated for desktop and/or portable use only. additional evaluation may be required as part of end product investigation to insure compliance of the product as mobile device. -- cf2.8 leakage current measurements must be performed on the combination power supply and the end-use product. -- cf2.9 installation instructions and end product markings are the responsibility of the end-use product manufacturer. -- cf3 at 90v~ input, the 12v model output is derated to 12vdc, 8.33a to comply with the temperature limit. above 90v~ input, the 12v model complies with the temperature limit with a rated output 12vdc, 9.165a -- cf3.1 earth leakage current was measured using figs 10 and 11 of ul60601-1. --
certificate ' i w206.1.59s 4.1...... ~ .. @ tuvrheinland certificate no. license holder: sl power electronics corp. 7105 northland terrace minneapolis mn 55428 usa manufacturing plant: sl power electronics xianghe anping economic and technical developing zone 065402 xianghe county, hebei china test report no.: tested to: usa-jak 09571156 062 client reference: tim cassidy en 60601-1:1990+a1+a2+a13 certified product: medical power supply license fee - units addition: model designation: mw155x1x2x3x3x4x4x5x6x6 (x1,x2 = a-z; x4,x6 = 0-9; x5 = f; xl, x2, x4, x6 not safety-relevant) rated voltage: 1) ac 100-110v, 50-60hz; or ac 110-240v, 50-60hz; (x3x3=12) 2) ac 100-240v, 50-60hz; (x3x3=15,18,24) 1) 2.0a or 2.0-1.0a; 2 ) 2. 0 - 1 . oa i rated current: protection class: contd. appendix: i, 1-5 inh. = 747695 / deb. = 747695 / fert. = 751962 licensed test mark: signatures date of issue (day/mo/yr) 08/07/2008 dkt stephan schmitt president a ien _1-1 j ll. 1ft i . . ,'. ('fi!!jffilijc. . ;.' ... . .,. [. g gla qa certification officer
certificate a .. @ tuvrheinland certificate no. i license holder: sl power electronics corp. 7105 northland terrace minneapolis mn 55428 usa manufacturing plant: sl power electronics xianghe anping economic and technical developing zone 065402 xianghe county, hebei china test report no.: tested to: usa-jak 09571156 062 client reference: tim cassidy en 60601-1:1990+a1+a2+a13 certified product: medical power supply license fee - units inh. = 747695 / deb. = 747695 / fert. = 751962 licensed test mark: signatures date of issue (day/mo/yr) 08/07/2008 d~t stephan schmitt president a ien 60601-1 fbtl1 ~ g gla qa certification officer contd. output ratings: 1) dc +12v, 8.33a (x3x3=12) dc +12v, 9.165a (x3x3=12) 2) dc +15v, 7.33a (x3x3=15) dc +18v, 6.66a (x3x3=18) dc +24v, 5.0a (x3x3=24)
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