COVER PAGE FOR TEST REPORT

Transcription

1

2

3 Issue Date: Page 1 of 2 Report Reference # E A4-UL-1 Amendment COVER PAGE FOR TEST REPORT Product Category: Product Category CCN: Test Procedure: Product: Model/Type Reference: Rating(s): Power Supplies, Medical and Dental QQHM2, QQHM8 Component Recognition Component - Power Supply MW159RA15XXQYY, where XX can be and represents the output connector style and YY can be and represents non-safety related customer options. MW159RAXYFZ, 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 MW159RA1549F02 is a Class II power supply using a Class I appliance inlet with a functional ground. MW159RA15XXQYY (Class II), MW159RA1549F02 (Class II with FE) Input: V~, 50/60 Hz, A; Output: 15Vdc, 5.33A MW159RAXYFZ (Class I): Input: V~, 50/60 Hz, A; Output: MW159RA12YFZ: 12Vdc,6.66A MW159RA15YFZ: 15Vdc, 5.33A MW159RA18YFZ: 18Vdc, 5A MW159RA24YFZ: 24Vdc, 4.2A Standards: UL , 1st Edition, (Medical Electrical Equipment, Part 1: General Requirements for Safety) CAN/CSA-C22.2 No M90, 2005 (Medical Electrical Equipment - Part 1: General Requirements for Safety) Applicant Name and Address: SL POWER ELECTRONICS CORP 6050 KING ST VENTURA CA UNITED STATES This Report includes the following parts, in addition to this cover page: 1. Specific Inspection Criteria 2. Specific Technical Criteria 3. Clause Verdicts 4. Test Results 5. Enclosures Copyright 2008

4 Issue Date: Page 2 of 2 Report Reference # E A4-UL-1 Amendment This is to certify that representative samples of the products covered by this Test Report have been investigated 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 such products which comply with this Test Report and any other applicable requirements of Underwriters Laboratories Inc. ('UL') in accordance with the Follow-Up Service Agreement. Only those products which properly bear the UL Mark are considered as being covered by UL's Follow-Up Service under the indicated Test Procedure. The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety. 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 Acceptability. Any information and documentation involving UL Mark services are provided on behalf of Underwriters Laboratories Inc. (UL) or any authorized licensee of UL. Test Report By: Reviewed By: Jim To Senior Project Engineer Underwriters Laboratories Inc. Denise Leung Klinker Staff Engineer Underwriters Laboratories Inc. Copyright 2008

5 Issue Date: Page 1 of 10 Report Reference # E A4-UL-1 Amendment SPECIFIC INSPECTION CRITERIA BA1.0 BA1.1 BB1.0 BB1.1 Special Instructions to UL Representative N/A Supporting Documentation The following documents located at the beginning of this Procedure supplement the requirements of this Test Report: A. Authorization - The Authorization page may include additional Factory Identification Code markings. B. Generic Inspection Instructions - i. Part AC details important information which may be applicable to products covered by this Procedure. Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of this Test Report. ii. Part AE details any requirements which may be applicable to all products covered by this Procedure. Products described in this Test Report must comply with any applicable items listed unless otherwise stated in the body of each Test Report. iii. Part AF details the requirements for the UL Certification Mark which is not controlled by the technical standard used to investigate these products. Products are permitted to bear only the Certification Mark(s) corresponding to the countries for which it is certified, as indicated in each Test Report. TRF No.: IEC60601_1C Underwriters Laboratories Inc.

6 Issue Date: Page 2 of 10 Report Reference # E A4-UL-1 Amendment BC1.0 BC1.1 BC1.2 Markings and instructions The following markings and instructions are provided as indicated. All clause references are from UL , 1st Edition, (Medical Electrical Equipment, Part 1: General Requirements for Safety). Standard Clause Title Clause 6.1e Company identification 6.1f Model Model number 6.1g Supply Connection Alternating current Direct current 6.1h Supply Frequency Marking or Instruction Details Classified or Recognized company's name, Trade name, Trademark or File Voltage range, ac/dc, phases if more than single phase Rated frequency range in hertz 6.1j Power Input Amps, VA, or Watts 6.1l Class II equipment 6.1p Output Rated output voltage, power, frequency. 6.1q Attention, consult accompanying documents 6.2f Protective earth ground TRF No.: IEC60601_1C Underwriters Laboratories Inc.

7 Issue Date: Page 3 of 10 Report Reference # E A4-UL-1 Amendment BD1.0 BD1.1 BD1.2 Production-Line Testing Requirements Test Exemptions - The following models are exempt from the indicated test Model Grounding Continuity Dielectric Voltage Withstand Patient Circuit Dielectric Voltage Withstand MW159RA15XXQYY Exempt Test Exempt Solid-State Component Test Exemptions - The following solid-state components may be disconnected from the remainder of the circuitry during either Dielectric Voltage Withstand Test: N/A BE1.0 BE1.1 Sample and Test Specifics for Follow-Up Tests at UL The following tests shall be conducted in accordance with the Generic Inspection Instructions Model Samples Test Test Details N/A N/A N/A N/A TRF No.: IEC60601_1C Underwriters Laboratories Inc.

8 Issue Date: Page 4 of 10 Report Reference # E A4-UL-1 Amendment SPECIFIC TECHNICAL CRITERIA TEST REPORT UL Medical Electrical Equipment Part 1: General requirements for safety Report Reference No...: E A4-UL-1 Compiled by...: Jim To Reviewed by...: Denise Leung Klinker Date of issue...: Standards...: UL , 1st Edition, (Medical Electrical Equipment, Part 1: General Requirements for Safety) CAN/CSA-C22.2 No M90, 2005 (Medical Electrical 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...: MW159RA15XXQYY, where XX can be and represents the output connector style and YY can be and represents nonsafety related customer options. MW159RAXYFZ, 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 MW159RA1549F02 is a Class II power supply using a Class I appliance inlet with a functional ground. Rating(s)...: MW159RA15XXQYY (Class II), MW159RA1549F02 (Class II with FE) Input: V~, 50/60 Hz, A; Output: 15Vdc, 5.33A MW159RAXYFZ (Class I): Input: V~, 50/60 Hz, A; Output: MW159RA12YFZ: 12Vdc,6.66A MW159RA15YFZ: 15Vdc, 5.33A MW159RA18YFZ: 18Vdc, 5A MW159RA24YFZ: 24Vdc, 4.2A TRF No.: IEC60601_1C Underwriters Laboratories Inc.

9 Issue Date: Page 5 of 10 Report Reference # E A4-UL-1 Amendment GENERAL INFORMATION Test item particulars (see also clause 5): Classification of installation and use...: Supply connection...: Accessories and detachable parts included in the evaluation...: Options included...: Possible test case verdicts: Portable Appliance coupler None None - 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 polarity: BOP - supplementary insulation... : SI - double insulation...: DI - reinforced insulation... : RI General remarks: - "(see Enclosure #)" refers to additional information 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 CA1.1 Report Summary N/A CB1.0 CB1.1 Product Description Component - Switching Power Supply CC1.0 CC1.1 Model Differences MW159RA15XXQYY is Class II unit, where XX can be and represents the output connector style and YY can be and represents non-safety related customer options. MW159RAXYFZ is Class I unit, 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 TRF No.: IEC60601_1C Underwriters Laboratories Inc.

10 Issue Date: Page 6 of 10 Report Reference # E A4-UL-1 Amendment Transformer P/N is for the 12 and 15 V models, and P/N is for the 18 and 24 V models. The two transformers have different winding turns. MW159RA1549F02 is Class II unit using a Class I appliance inlet with a functional earthing. This model is identical to model MW159RA1551F01 in construction. CD1.0 CD1.1 Additional Information The schematics for these models are kept in file at the CB Testing Laboratory mentioned in the first page of this test report, and can be provided by the manufacturer upon request by NCB's/CBTL's. CE1.0 CE1.1 CE1.2 CE1.3 CE1.4 CE1.5 Technical Considerations The product was investigated to the following additional standards: The product was not investigated to the following standards or clauses: The product is Classified only to the following hazards: The degree of protection against harmful ingress of water is: The following accessories were investigated for use with the product: UL , 1st Edition, (includes National Differences for USA); EN : A1: A2: A13:1996, (except EMC limitations, EN , Biocompatibility, EN , Programmable Electronic Systems, IEC ); CAN/CSA- C22.2 No M90 (R2005) (includes National Differences for Canada) Clause 36, Electromagnetic Compatibility (IEC ), Clause 48, Biocompatibility (ISO ), Clause 52.1, Programmable Electronic Systems (IEC ) Casualty, Fire, Shock Ordinary None CE1.6 The mode of operation is: Continuous CE1.7 Software is relied upon for meeting safety No requirements related to mechanical, fire and shock: 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 CF1.1 Engineering Conditions of Acceptability For use only in or with complete equipment where the acceptability of the combination is determined by Underwriters Laboratories Inc. When installed in an end-product, consideration must be given to the following: CF2.0 This component has been judged on the basis -- TRF No.: IEC60601_1C Underwriters Laboratories Inc.

11 Issue Date: Page 7 of 10 Report Reference # E A4-UL-1 Amendment CF2.1 CF2.2 CF2.3 CF2.4 CF2.5 CF2.6 CF2.7 of the required spacings in the First Edition of the Standards for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL , which covers the end use product for which the component is designed. The component is provided with a plastic enclosure (V-0) that is suitable for fire and shock hazards. The output circuits have not been evaluated for direct patient connection (Type B, BF or CF). The Temperature Test was performed in an ambient of 25 C and temperatures were calculated for a raised ambient of 40 C. The MW159RA15XXQYY power supply was evaluated as Reinforced insulation between primary and secondary; basic insulation between primary to heatsink; and supplementary insulation between secondary to heatsink. The MW159RAXYFZ power supply was evaluated as Reinforced insulation between primary and secondary; basic insulation between primary to ground/heatsink; and operational insulation between secondary to heatsink. The MW159RA15XXQYY power supply has been evaluated as Class II equipment and the MW159RAXYFZ power supply as Class I equipment. Model MW159RA1549F02 is a Class II unit that uses Class I appliance inlet for Functional Earth (FE) purposes. All have been evaluated for continuous operation, and have not been evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Under normal and single fault conditions, the outputs do not exceed 25 V ac or 60 V dc. The product was evaluated as a desk top 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 TRF No.: IEC60601_1C Underwriters Laboratories Inc.

12

13

14

15

16

17

18 Certificatc Numbcr: 8518 CERTIFICATE OF SUITABILITY 'l'his is to certify that articles of the same type as the article specified below and \ari:rtions so spccificd rre accept d by the OFFICE OF FAIR TITADI)iG as suitable for connection to public electricilv suppl"v in NEW SOUTII WALES in accordancc rvith the provisions of AS3000 subject to the conditions stated. Article: Po$er supply for mcdical equipment, housed in thcrmoplastic enclosure and incorporating an inlet socket for connection to suppll. Input: V AC, 50liz,.'l - 0.7A Output: l5v DC, 5.3JA Where YY dcnotcs for non safetv relatcd issucs. Identillcation: MWl59RAlSllQYY Eramined for compliance rrilh: AS/NZSI2O0.1.0:1998 lssued to: SL Power Eleclronics Corp Nom idatcd Marking: CS85l8N Con d it ions: l. This certilicate lrill be rrithdraln automaticall] if an article of this t) pe is declared pursuanto thc lllcctricit) (Consumer Safett ) Act, This certificate is issued subject to the articlc and acceptcd variations thcreof being maintained at the standard of the article eranrined at the time Of accedtancc. Appror ed: 27 September 2007 This approral expires 25 Scptember 2012 unles suspended, canccllcd, rcnclvcd or ertended. ')/ 'l ( L-' / \ for Coin m isrlo+er for,fair Trading 'l

19 Re f: CS85l8/l for consumers & traders ADDENDUM TO CEITTIFICATE OF SUITABIT,ITY 85I8 Particulars of Modilication(s) Nlodification modcl no. MWl59lfAl5XXQYY is sinlilar to original model no. NI$'l59ltAl5.llQYY e\cept that XX denoles for different stt les of output connector. Appro\ed: 27 September 2007,/ \,/.i I /\(--t' lbr Cornn)is\isncr lbr Fair Trading Satctt and Standards Branch, Office of Fair Trading, Bradfield Road, Lindfield West Em ail: cncrgvapprovalsfa-roft.com merce.nslv.go!.au rr n rv.fairtrading.nsw.gor'.au l3 3220

20 Ref: CS85l8/2 ADDENDUM TO CERTIFICATE OF SUITABILITY 85I8 Particula rs of Modification(s) Model MWI59RAXX03FZZ similar to Model MWI59RAISXXQYY except for: a) Having class I construction instead ofclass li construction. b) Use of Cl4 inlet instead of Cl8 inlet. c) In the model number the lctters'xx'denote output voltage being 12, 15, l8 or 2,1V. d) In the model number the letters'zz' denote non-safety related issues. e) Designation. Approved: l-1 May 2008 for Commissioner for Fair Trading Safety and Standards Branch, Office of Fair Trading, Bradfield Road, Lindfield West energyapprovals@oft.com merce.nsw.gov.au *'ll'lv.fairtrading.nsw.gov.au

21 I{rf: C5351 li;.1 lcr ltrslirtn'i & tlrdei's \ Il l-) L, \ I) L 1l l'{} {' l- l{1" I l:} 4.1'l' I: 11 p 'f.\ l-l f.,\ ll I L. ll-\ tji I I I'srf iculrrrs o1' \Ildii'icri tilrr{.r) lltrr.lr'l \o" 1l\\ l59l{i\x.\1'1 f:3.-r- }ri.lrig lirrriltir. 1l }1i:rJr'l \t '\'1'' ttrr.lililrr tirr: 0u1prrl!iJtl11rrt{rt' f1 J}r Xl\\.' I i{}l{,"\\x{i3t"zl rrlegrt rr }rllr- '\ppr'tllt!: :.il,lu u* :i.l{},l I lir r {'* rn rr irsiunt'r' fi.r r' l;rr it"l' r'llrl int \;tir"'ir:rtttl!trtrttlrtrtlr iirilnth. {}tlicr"'ll^llil' l-r";rrlirrg. Ilrrirllir:lrl lllrrti. l.,inrll'ir'lti \\*rt l: rrilri l : elrcig1 li 1t1t rir,* ls'li 0 l'f.ccill lrr er-lc,ns11.xo1.:l u tr * rr.1'rrit'fi'lt{lirrg.lrsrr.gtr.au lf _l::{,}

22