Issue Date: 2007-09-21 Page 1 of 2 Report Reference # E116994-A37-CB-1 COVER PAGE FOR TEST REPORT Test Item Description: Model/Type Reference: Rating(s): Power Supply GEM600-VV-WXY-ZZ G and GEM750-VV-WXY-ZZ G. Where VV is the output Voltage 24-48VDC, may also be followed by "-XYZ", where W is an Alpha character A or T, which represents the Input Connector, X is an alpha character A, B or T which represents the Output Connector, Y is an Alpha Character D, which represents the Optional OR-ing Diode, may also be followed by "-ZZ" is any numeric character 00-99 which represents Value Added Configurations not related to safety and "G" indicates compliance with the RoHS directive. (RoHS compliance has not been evaluated by UL.) GEM600-VV-WXY-ZZ G Input: 100-240 V~, 50/60 Hz, 9 A/4.5 A GEM750-VV-WXY-ZZ G Input: 100-240 V~, 50/60 Hz, 11 A/5.5 A Output: GEM600 V A 24 25 28 21.5 36 16.7 48 12.5 GEM750 V 24 28 32 36 48 Standards: Applicant Name and Address: Factory Location(s): A 31.2 26.8 23.4 20.8 15.6 + Maximum current output with Airflow of 42 CFM with an integral fan at an ambient of 50°C. IEC 60601-1:1988 + A1:1991 + A2:1995 SL POWER ELECTRONICS CORP 6050 KING ST VENTURA CA 93003 INDUSTRIAS S L S A DE C V COSTA RICA #60 COL CUAHUTEMOC MEXICALI BAJA CALIFORNIA N MEXICO SL POWER ELECTRONICS XIANGHE ANPING ECONOMIC & TECH DEVELOPING ZONE XIANGHE, Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 4 of 65 Report Reference # E116994-A37-UL-1 SPECIFIC TECHNICAL CRITERIA TEST REPORT UL 60601-1 Medical Electrical Equipment Part 1: General requirements for safety Report Reference No ........................: E116994-A37-UL-1 Compiled by .....................................: Ahmad Daoudi Reviewed by ....................................: Kent C. Jones Date of issue ....................................: 2007-09-21 Standards .........................................: UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, Part 1: General Requirements for Safety) CAN/CSA-C22.2 No. 601.1-M90, 2005 (Medical Electrical Equipment Part 1: General Requirements for Safety) Test procedure .................................: Component Recognition Non-standard test method ...............: N/A Test item description .......................: Power Supply Trademark ........................................: Model and/or type reference ............: GEM600-VV-WXY-ZZ G and GEM750-VV-WXY-ZZ G. Where VV is the output Voltage 24-48VDC, may also be followed by "-XYZ", where W is an Alpha character A or T, which represents the Input Connector, X is an alpha character A, B or T which represents the Output Connector, Y is an Alpha Character D, which represents the Optional OR-ing Diode, may also be followed by "-ZZ" is any numeric character 00-99 which represents Value Added Configurations not related to safety and "G" indicates compliance with the RoHS directive. (RoHS compliance has not been evaluated by UL.) Rating(s) ...........................................: GEM600-VV-WXY-ZZ G Input: 100-240 V~, 50/60 Hz, 9 A/4.5 A GEM750-VV-WXY-ZZ G Input: 100-240 V~, 50/60 Hz, 11 A/5.5 A Output: GEM600 V A 24 25 28 21.5 36 16.7 48 12.5 GEM750 TRF No.: IEC60601_1C Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 5 of 65 V 24 28 32 36 48 Report Reference # E116994-A37-UL-1 A 31.2 26.8 23.4 20.8 15.6 + Maximum current output with Airflow of 42 CFM with an integral fan at an ambient of 50°C. TRF No.: IEC60601_1C Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 6 of 65 Report Reference # E116994-A37-UL-1 GENERAL INFORMATION Test item particulars (see also clause 5): Classification of installation and use ......................... : For building-in Supply connection ..................................................... : Terminal block Accessories and detachable parts included in the evaluation .................................................................. : None Options included ....................................................... : Terminal Block, Bussbars, Phoenix Contact, or N+1 OR-ing Diode. 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 polarity: BOP - supplementary insulation ......... : SI - double insulation ............................................ : DI RI - reinforced insulation ................ : 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 Report Summary CA1.1 N/A CB1.0 Product Description CB1.1 The equipment (DC power supplies) covered by this report are components which are intended for use in end-product equipment used in a hospital or related health care facility, evaluated to the standard for Medical Equipment. The GEM Series or power supplies are designed for building-in to an end product. They are designed with 1 cover mounted integral fan rated at 42 CFM. Rated Ambient is 50°C. CC1.0 Model Differences CC1.1 All models within the Model Series GEM600 are similar to each other except for Main Power TRF No.: IEC60601_1C Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 7 of 65 Report Reference # E116994-A37-UL-1 Transformers and minor component changes. All models within the Model Series GEM750 are similar to each other except for the Main Power Transformers and minor component changes. Model Series GEM600 and Model Series GEM750 are similar, except for the Power FET's, which are more robust in the GEM750 Series. Nomenclature for Model Series GEM600-VV-WXY-ZZ G and Model Series GEM750-VV-WXY-ZZ G, where VV = the output Voltage 24-48VDC W = an Alpha character A or T, which represents the Input Connector, X = an alpha character A, B or T which represents the Output Connector, Y = an Alpha Character D, which represents the Optional OR-ing Diode, -ZZ= any numeric character 00-99 which represents Value Added Configurations not related to safety G = indicates compliance with the RoHS directive. (RoHS compliance has not been evaluated by UL.) OPTIONS: A - Terminal Block (EBY P/N 5002-03-N-12) B - Bussbars T - Phoenix Contact (P/N 173204) D - N+1 OR-ing Diode. Will allow 2 or more power supplies to be connected in parallel and share the output load. CD1.0 Additional Information CD1.1 The schematics for these models are kept on file at the CB Testing Laboratory mentioned in the first page of this test report, and can be provided by the applicant upon request by CBTL's/NCB's. Only limited testing was considered necessary on Model GEM750-48 due to testing conducted as part of a similar already evaluated Model Series GPHP600 and GPHP750 covered under Test Report Reference E116994-A16-CB-1, CB Certificate US/8708/UL . CE1.0 Technical Considerations CE1.1 The product was investigated to the following additional standards: EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94, and CAN/CSA C22.2 No. 601.1B-98 (National Differences for Canada), (except EMC limitations, EN 60601-1-2, Biocompatibility, EN 10993-1, Programmable Electronic Systems, IEC 60601-1-4) 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) TRF No.: IEC60601_1C Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 8 of 65 Report Reference # E116994-A37-UL-1 CE1.3 The product is Classified only to the following hazards: Shock, Fire, CE1.4 The degree of protection against harmful ingress of water is: Ordinary CE1.5 The following accessories were investigated for None 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 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 power supply has been evaluated as Class -I with no applied parts, 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. CF2.1 This component has been judged on the basis -of the required spacings in the Standards for Medical Equipment, Part 1: General Requirements for Safety, UL60601-1, First Edition (2003) , IEC60601-1, Second Edition (1998) and CSA 22.2 No. 601.1, which covers the end use product for which the component is designed. CF2.2 The component shall be installed in compliance -with the enclosure, mounting, spacings, casualty markings and segregation requirements of the end-use application. CF2.3 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. CF2.4 The input/output are not acceptable for field connection, they are only intended for connection to mating connectors of internal wiring inside the end-use machine. The output circuits have not been evaluated for direct TRF No.: IEC60601_1C -- Underwriters Laboratories Inc. Issue Date: 2007-09-21 Page 9 of 65 Report Reference # patient connection (Type B, BF or CF). CF2.5 The component should be properly bonded to the ground in the end-use equipment. CF2.6 The temperature test was performed in a raised -ambient of 50°C. CF2.7 Leakage Current testing should be repeated in the end-product application. -- CF2.8 The main Power Transformer (T6) and Bias Transformer (T7), comply with Class F (155°C) limits. -- CF2.9 Additional fusing should be considered in the -end product since this power supply was tested with only one internal fuse, rated T 12A, 250 V. CF3 Humidity and Blocked Ventilation Cooling -Abnormal Testing should be considered as part of the end-use application. TRF No.: IEC60601_1C -- Underwriters Laboratories Inc. E116994-A37-UL-1