MR. DANIEL MITCHELL SL POWER ELECTRONICS CORP BLDG A 6050 KING ST VENTURA CA 93003 Date: Subscriber: PartySite: File No: Project No: PD No: Type: PO Number: 2012/02/01 100100487 946418 E116994 11NK16955 12O03592 R Subject: Procedure And/Or Report Material The following material resulting from the investigation under the above numbers is enclosed. Issue Date Vol Sec Pages Revised Date 2011/09/24 3 1 Additional Copy of Section/Report “Revised above Section” Please file revised pages and illustrations in place of material of like identity. New material should be filed in its proper numerical order. NOTE: Follow-Up Service Procedure revisions DO NOT include Cover Pages, Test Records and Conclusion Pages. Report revisions DO NOT include Authorization Pages, Indices, Section General Pages and Appendixes. Please review this material and report any inaccuracies to UL's Customer Service Professionals. 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NBK File Issued Date: 2011-09-24 Revised: 2012-01-21 Page 1 of 10 Report Reference# E116994-V3-S1 UL TEST REPORT AND PROCEDURE Standard: Certification Type: CCN: Product: Model: ANSI/AAMI ES60601-1:2005 (Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance); CSA C22.2 No. 60601-1:08 (Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance) Component Recognition QQHM2, QQHM8 (Power Supplies, Medical and Dental) Switching Power Supply MINT1045VWWXXYZZ, where V represents the generational differences which may be either A or B (A is for Class I and B is for Class II construction), WW represents the output voltage which may be any number from 12 to 48, XX represents output connector which may be any two alphanumeric digits, Y represents the input connector which may be any letter from A thru Z, and ZZ represents non-safety related customer options and may be followed by an optional suffix “G” which represents compliance to RoHS statements . MINT1045A1575K02 Rating: Input: 100-240V~, 50-60Hz, 1.0A Output: Refer to test report additional information. Applicant Name and Address: SL POWER ELECTRONICS CORP 6050 KING DRVIE, BLDG. A VENTURA, CA 93003, USA 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. Any information and documentation involving UL Mark services are provided on behalf of Underwriters Laboratories Inc. (UL) or any authorized licensee of UL. Copyright © 2011 Issued Date: 2011-09-24 Revised: 2012-01-21 Page 2 of 10 Report Reference# E116994-V3-S1 Alexander Perevezentsev Prepared by: Reviewed by: Underwriters Laboratories of Canada David V. Alma David V. Alma UL LLC Copyright © 2011 Issued Date: 2011-09-24 Revised: 2012-01-21 Page 3 of 10 Report Reference# E116994-V3-S1 Supporting Documentation – For UL Field Representative’s Use The following documents 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. Product Description The MINT1045AWWXXYZZ series (Class I type), and MINT1045BWWXXYZZ series (Class II type) are openframe AC/DC power supplies, designed for building-in to an end-product. All models have one dc output. Model Differences All Models are similar except for Class I or Class II configurations and output electrical ratings. Model MINT1045A1575K02 is identical to Model MINT1045A1575K01 except provided with perforated plastic cage (does not serve as Electrical, Mechanical, or Fire enclosure), and its output reduced to 40W. Technical Considerations – For engineering use The product was investigated to the following additional standards: ANSI/AAMI ES60601-1, CAN/CSA-C22.2 No. 60601-1:08, (includes National Differences for Canada), EN 60601-1: 1990 + A1:1993 + A2:1995, (except EMC limitations, EN 60601-1-2, Biocompatibility, EN 10993-1, Programmable Electronic Systems, IEC 60601-1-4) Scope of Power Supply evaluation defers the following clauses to be determined as part of the end product: Clause 4.2 (Risk Management), Clause 7.5 (Safety Signs), Clause 7.9 (Accompanying Documents), Clause 9 (ME Hazard), Clause 10 (Radiation), Clause 14 (PEMS), Clause 16 (ME Systems) The equipment has been evaluated for use in a maximum ambient of 50°C. The product is Classified only to the following hazards: Shock, Fire, Casualty The degree of protection against harmful ingress of water is: Ordinary The mode of operation is: Continuous Software is relied upon for meeting safety requirements related to mechanical, fire and shock: No The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide: No Issued Date: 2011-09-24 Revised: 2012-01-21 Page 4 of 10 Report Reference# Power Supply was considered Overvoltage Category II (OVCII) Classification of installation and use : Building-in Supply connection : Building-in Accessories and detachable parts included in the evaluation : None E116994-V3-S1 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: The component shall be installed in compliance with the Marking (clause 7) and Separation (clause 8) requirements of the end use application. Consideration should be given to measuring the temperature on power electronic components and transformer windings when the power supply is installed in the end-use equipment. The end use product shall ensure that the power supply is used within its ratings. Transformer T1 is provided with a Class F (155ºC) insulation system. Leakage current testing should be conducted in the end product application. For Class I configurations, Two MOPP is provided between primary and secondary; One MOPP primary and Earth;Protective impedance and creepage/clearance distances equal to 1MOP are provided between secondary and Earth. For Class II configurations, Two MOPP is provided between primary and secondary, One MOP is provided between primary and chassis, 1 MOP is provided between secondary and chassis. This power supply has been evaluated as continuous operation, ordinary equipment and has not been evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The output circuits have not been evaluated for direct patient connection (Type B, BF or CF). The end product should ensure that the requirements related to accompanying documents, clause 7.9, are met. The available voltage for the secondary outputs does not exceed 25 Vac or 60 Vdc, under normal and single fault conditions. The input/output connectors are not acceptable for field connections; they are only intended for connection to mating connectors of internal wiring inside the end-use machine. The need for Marking Durability and Marking Legibility Testing to be considered as part of the end product installation. Both Line and Neutral of the power supplies are provided with fusing. End product Risk Management Process to include consideration of requirements specific to the Power Issued Date: 2011-09-24 Revised: 2012-01-21 Page 5 of 10 Report Reference# E116994-V3-S1 Supply. End product Risk Management Process to consider the acceptability of risk for the following components that were identified as High-Integrity Component: Fuse (F1, F2), Optocoupler (U1) Single fault testing was conducted without dielectric breakdown, however end product Risk Management Process to consider the need for simultaneous fault condition testing. End product Risk Management Process to consider the need for different orientations of installation during testing. Humidity testing was conducted, however the end product Risk Management Process to determine risk acceptability criteria. End product to determine the acceptability of risk in conjunction to insulation to resistance to heat, moisture, and dielectric strength. Components were secured to prevent movement, however end product to determine the acceptability of risk in conjunction to the movement of components as part of the power supply. Wiring was secured to prevent movement of wire where conductor could be damaged or contact unwanted voltages, however end product to determine the acceptability of risk in conjunction to the movement of conductors as part of the power supply. Temperature Test was conducted without Test Corner. End product to determine the acceptability of risk in conjunction to temperature testing without test corner as part of the power supply. End product to determine the acceptability of risk in conjunction to the selection of components as it pertains to the intended use, essential performance, transport, storage conditions as part of the power supply. End product to provide fusing that has adequate breaking capacity to interrupt the maximum fault current including the available short-circuit in accordance with clause 8.11.5. Power supply complies with the limits of 8.4.2.c. The expected service life of this product is 5 years. Models MINT1045B series are Class II products the need for IEC symbol 60417-5172 should be considered in the end use product. Additional Information Output: 12Vdc, 3.75A to 48Vdc, 0.95A, maximum 45 Watts (for all Models except MINT1045A1575K02) Model MINT1045A1575K02 output: 15 Vdc, 2.66 A, maximum 40 Watts Markings and instructions – For UL Field Representative Use Clause Title Marking or Instruction Details Issued Date: 2011-09-24 Revised: 2012-01-21 Page 6 of 10 Report Reference# E116994-V3-S1 Company identification Classified or Recognized company's name, Trade name, Trademark or File Model Model number Fuses Ratings (current and voltage) and type. (located adjacent to fuse OR as a diagram inside enclosure) Special Instructions to UL Representative : N/A Production-Line Testing Requirements – For UL Field Representative Use Test Exemptions - The following models are exempt from the indicated test Model Grounding Continuity Dielectric Voltage Withstand Patient Circuit Dielectric Voltage Withstand All Models Exempt Exempt 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: Sample and Test Specifics for Follow-Up Tests at UL The following tests shall be conducted in accordance with the Generic Inspection Instructions Model N/A Samples Test Test Details Issued Date: 2011-09-24 Revised: 2012-01-21 Page 7 of 10 Report Reference# E116994-V3-S1 TABLE: List of Critical Components Object/part or Description Manufacturer/ trademark type/model technical data CCN Marks of Conformity Connectors (primary) (J1) Connectors (Secondary) (J2) Fuse (F1, F2) Fuse (F1, F2) Alternate Fuse (F1, F2) Alternate Fuse (F1, F2) Alternate Line Filter (L1) Various Various Rated Min. 2A, 300V ECBT2/8 UL,CN Various Various -- ECBT2, RTRT2 UL,CN Conquer Walter MST 2010 250 Vac, T1A 250 Vac, T1A JDYX2 JDYX2 UL,CN UL,CN Littelfuse 392 250 Vac, T1A JDYX2 UL,CN Bussmann SS-5 250 Vac, T1A JDYX2 UL,CN SL Power Electronics SL Power Electronics Liteon Meritek Xiamen Fara 05-35414-7001 - - - - LTV817A-V MEX MKP62 See Enclosure 3 for details. Evaluated as part of this investigation. See Enclosure 4 for details. Evaluated as part of this investigation. 5000 Vac isolation Rated Min. 250 Vac, Max. 0.47 µF Rated Min. 250 Vac, Max. 0.47 µF FPQU2/8 FOWX2/8 FOWX2/8 UL,CN UL,CN UL,CN Vishay 339 Rated Min. 250 Vac, Max. 0.47 µF FOWX2/8 UL,CN Kemet Electronics PHE840E Rated Min. 250 Vac, Max. 0.47 µF FOWX2/8 UL,CN Okaya LE474-M Rated Min. 250 Vac, Max. 0.47 µF FOWX2/8 UL,CN Vishay Murata WKP KX Y1 type, Rated Min. 250 Vac, Max. 330 pF Y1 type, Rated Min. 250 Vac, Max. 330 pF FOWX2/8 FOWX2/8 UL,CN UL,CN Meritek AH Y1 type, Rated Min. 250 Vac, Max. 330 pF FOWX2/8 UL,CN Various Various Rated 562 Kohm N/A - Line Filter (L2) Optical Isolator (U1) X-Capacitor, (C6) X-Capacitor, (C6) Alternate X-Capacitor, (C6) Alternate X-Capacitor, (C6) Alternate X-Capacitor, (C6) Alternate Y-Capacitor, (C19, C10) Y-Capacitor, (C19, C10) - Alternate Y-Capacitor, (C19, C10) - Alternate Bleeder resistors (R2, 05-35483-7001 Issued Date: 2011-09-24 Revised: 2012-01-21 Page 8 of 10 Report Reference# E116994-V3-S1 Object/part or Description Manufacturer/ trademark type/model technical data CCN Marks of Conformity R6) Resistor (R45). -- -- -- -- Varistor (M1) - Alternate Varistor (M1) - Alternate Capacitor, Electrolytic (C7) Insulation Tape wrapped on M1 and C7 Capacitor, Electrolytic (C4) Transistor (Q3) Bridge Rectifier (D1) Heatsink for Q3 (Pri.) Heatsink for D5/Q10 (Sec.) Transformer (T1). Meritek Thinking -- MVR10D511KS TVR14511 -- Rated Min. 0.25W, 10M ohm Provided on Models MINT1045A, (Class I) only, Not installed for Class II models. 320V, 33J, for SPD Type 2 application 320V, 33J, for SPD Type 3 application Rated Min. 400 V, 105 degree C, 120 uF VZCA2/8 VZCA2/8 -- UL,CN UL,CN --. Intertape 51592 Min. 2 layers provide, Rated 130 degree C OANZ2 UL Various Various Rated min. 105 degree C. - - ----- --Aluminum Aluminum Rated Min. 11A, 600V Rated Min. 2 A, 600 V See Illustration 2 for details See Illustration 1 for details ----- ----- SL Power Electronics Class F. See Illustration 5 for details. Evaluated as -part of this investigation. - Insulation System (T1) SL Power Electronics Rubadue 5-36322-7012-1 (12V), 5-363227015-1 (15V), 536322-7024-1 (24V), 5-363227048-1 (48V) F4 Class F insulation system. OBJY2 UL T20A01TXX-1.5, T22A01TXX-1.5, T24A01TXX-1.5 Various Zytel 103HSL (Nylon 66) 20 AWG, 22 AWG, 24 AWG respectively; 155 ºC, 1 kVpk, comply with Annex U of 60950-1 OBJT2 UL Min V-0, 130 ºC Rated 94V2 RTI Electrical 140 ZPMV2 QMFZ2 UL UL Rated 94V2 RTI Electrical 130 QMFZ2 UL TIW (secondary of T1) Printed wiring board Plastic Enclosure (MINT1045A1575K02 Model Only) Plastic Enclosure Various E I Dupont Lanxess Durethan A 30 S Issued Date: 2011-09-24 Revised: 2012-01-21 Object/part or Description (MINT1045A1575K02 Model Only) (Alternate) Page 9 of 10 Manufacturer/ trademark type/model Report Reference# technical data E116994-V3-S1 CCN Marks of Conformity Issued Date: 2011-09-24 Revised: 2012-01-21 Page 10 of 10 Report Reference# E116994-V3-S1 Enclosures Type Supplement Id Description Photographs Fig.1 Top View Photographs Fig.2 Side View Input Photographs Fig.3 Side View Output Photographs Fig.4 Bottom View Photographs Fig.5 Model MINT1045A1575K02 overall view Photographs Fig.6 Model MINT1045A1575K02 plastic cage Diagrams ILL.2 Q3 Heat Sink Diagrams ILL.3 L1 Choke Diagrams ILL.4 L2 Choke Diagrams ILL.5 Transformer T1 Diagrams ILL.6 Main Board - Component/Trace Layout File E116994 Vol. 3 Sec. 1 And Report FIG-1 N110815325 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report FIG-2 N110815326 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report FIG-3 N110815327 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report FIG-4 N110815328 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report FIG-5 N120850284 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report FIG-6 N120850285 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report ILL-1 N110815370 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report ILL-2 N110815371 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report ILL-3 N110815372 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report ILL-4 N110815373 Issued: 2011-09-24 File E116994 Vol. 3 Sec. 1 And Report ILL-5(Page 1)Issued: 2011-09-24 N110815374 File E116994 Vol. 3 Sec. 1 And Report ILL-5(Page 2)Issued: 2011-09-24 N110815374 File E116994 Vol. 3 Sec. 1 And Report ILL-6(Page 1)Issued: 2011-09-24 N110815375 File E116994 Vol. 3 Sec. 1 And Report ILL-6(Page 2)Issued: 2011-09-24 N110815375 File E116994 Vol. 3 Sec. 1 And Report ILL-6(Page 3)Issued: 2011-09-24 N110815375 File E116994 Vol. 3 Sec. 1 And Report ILL-6(Page 4)Issued: 2011-09-24 N110815375 Issue Date: 2011-09-24 Page T1-1 of 1 Report Reference #E116994-V3-S1 Test Record No. 1 The Switching Power Supply models MINT1045A4875K01 and MINT1045A1275K01 constructed as described herein were submitted by the manufacturer for examination and test. The Models MINT1045A4875K01 and MINT1045A1275K01 were considered representative of all other models in the MINT1045 Series. Test results relate only to the item tested. Unless otherwise indicated, all tests were conducted at Ault (Shanghai) Electronics Co., Ltd., 4 th Floor, #53 Building, No. 1089, Qinzhou North Rd., Shanghai, 200233 P.R. China. The following tests were conducted: Test Testing Location/Comments Input Test (4.11) Humidity Preconditioning (5.7) Underwriters Laboratories 455 East Trimble Road, San Jose, CA 95131 Low Voltage Reliability (8.4.2 and 8.11.1) Working Voltage Measurement (8.5.4) Earthing and Potential Equalization (8.6.4) For Information only, end product. Earth Leakage Current (8.7) Dielectric Strength (8.8.3) Short Circuiting In Lieu Creepage Distances And Air Clearance (8.9.2) Temperature Test (11.1) Abnormal Operation And Single Fault Conditions (13.2) Transformer Overload And Short-Circuit Tests (15.5.1) Transformer Dielectric Voltage Withstand (15.5.2) Underwriters Laboratories Inc. Underwriters Laboratories 455 East Trimble Road, San Jose, CA 95131 Issue Date: 2011-09-24 New: 2012-01-21 Page T2-1 of 1 Report Reference #E116994-V3-S1 Test Record No. 2 The Switching Power Supply model MINT1045A1575K02 constructed as described herein was submitted by the manufacturer for examination and test. Model MINT1045A1575K02 is identical to Model MINT1045A1575K01 except provided with perforated plastic cage (does not serve as Electrical, Mechanical, or Fire enclosure), and its output reduced to 40W. Due to similarity to the existing Model only tests listed below were considered necessary. Test results relate only to the item tested. Tests conducted according to ANSI-AAMI ES 60601-1-2005, CSA C22.2 No. 606011-08, EN/IEC 60601-1, 3rd Ed. All tests were conducted by SL Power Electronics Corp., 6050 King DR., Bldg. A, Ventura, CA 93003, USA, under CTDP. The following tests were conducted: Test Testing Location/Comments Power Input Test (4.11) - Temperature Test (11.1) Followed by Dielectric Test (8.8.3) Transformer Short Circuit Test (15.5.1) -"- Output Short Circuit test (13.2) -"- Output Overload / Energy Hazards Measurement Test (13.2) -"- TEST SUMMARY: The results of the investigation indicate compliance with the applicable requirements and, therefore, such products are judged eligible to bear UL’s Mark as described on the Conclusion Page of this Report. Test Record by: Reviewed by: Alexander Perevezentsev Engineering Team Leader Underwriters Laboratories of Canada David V. Alma Staff Engineer UL LLC Underwriters Laboratories Inc.