File E116994 Project 99SC53255 November 29, 1999 REPORT ON COMPONENT - POWER SUPPLIES, MEDICAL ELECTRICAL EQUIPMENT Condor DC Power Supplies Inc. Oxnard, California Copyright 1999 Underwriters Laboratories Inc. Underwriters Laboratories Inc. authorizes the above-named company to reproduce the latest pages of that portion of this Report consisting of this Cover Page through Page 3. File E116994 Vol. 1 Sec. 64 and Report Page 1 Issued: Revised: 1999-11-29 2007-12-13 DESCRIPTION PRODUCT COVERED: * USR, CNR Switching Power Supply, Models GPFM250-15-104, GPFM250-24-C-11, GPFM250-24-112, GPFM250-24-116 and GPFM250-X-C-H-YYY where X equals any number from 3.3 through 48, C is optional cover/fan, H indicates the neutral fuse and fuseholder are not provided, and YYY equals any number from 000 through 999. The –YYY suffix are used for value added configurations that have no impact on safety. May be followed by an optional Suffix “G”, which indicates compliance with RoHS. (RoHS Compliance has not been evaluated by UL.) ELECTRICAL RATINGS: Input: Output: 100-240 V ac, 50-60 Hz, 6 A. Maximum watts = 180 W convection cooled, 250 W with cover fan option or minimum 150 LFM airflow. Maximum current = 50 A Maximum volts = 48 V 24 V dc max., 12.5 A (300 W for model GPFM250-24-C-11) 24 V dc max., 7.5 A (180 W for model GPFM250-24-112) 24 V dc max., 5.8 A Cont. (140 W for model GPFM250-24-116) ENGINEERING CONSIDERATIONS (NOT FOR FIELD REPRESENTATIVE'S USE): For use in product where the acceptability of the combination is determined by Underwriters Laboratories Inc. USR indicates that the product was evaluated to the First Edition of the Standard For Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1. CNR indicates that the product was evaluated to the Standard For Medical Electrical Equipment, Part 1: General Requirements for Safety, CSA C22.2, No. 601.1-M90. Engineering References - Following Illustrations are provided for engineering references: ILL. 1 - Insulation diagram of the equipment. ILL. 2 – Installation Instructions File E116994 Vol. 1 Sec. 64 and Report Page 2 Issued: Revised: 1999-11-29 2005-06-21 Condition of Acceptability - When installed in the end-use equipment, the following are among the considerations to be made: 1. This component has been judged on the basis of the required spacings in the Standards for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1, 1st Edition and CSA C22.2 No. 601.1-M90, which cover the end use product for which the component is designed. 2. The component shall be installed in compliance with the enclosure, mounting, spacing, casualty markings and segregation requirements of the end-use application. 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. 4. 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. 5. The output circuits have not been evaluated for direct patient connection (Type B, BF or CF). 6. The component should be properly bonded to ground in the end-use equipment. 7. The Temperature Test was performed in a raised ambient of 50°C. 8. The main isolation transformer, T4, complies with Class 155 (F) limits. 9. Leakage current testing should be repeated in the end product application. 10. The power supply was evaluated as Reinforced insulation between primary and secondary and basic insulation between primary to ground. 11. This power supply has been evaluated as Class I, continuous operation, ordinary equipment and has not been evaluated for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide. 12. The grounding trace on the PWB has not been evaluated as the Protective Earthing path for any metal parts accessible in the end product. However, the grounding path was subjected to the Earthing Test per Clause 18 (25 A for 5 seconds) with acceptable results. 13. Only Clause 5 and input rating requirements are evaluated for the manual. Other manual requirements should be evaluated in the endproduct.