File E116994 Project 97SC11830 1997-10-17 REPORT ON COMPONENT - POWER SUPPLIES, MEDICAL AND DENTAL EQUIPMENT Condor D C Power Supplies Inc. Oxnard, California Copyright © 1997 Underwriters Laboratories Inc. Underwriters Laboratories Inc. authorizes the above-named company to reproduce this Report provided it is reproduced in its entirety. Underwriters Laboratories Inc. authorizes the above-named company to reproduce that portion of this Report consisting of this Cover Page through Page 3. File E116994 Vol. 1 Sec. 50 and Report Page 1 Issued: Revised: 1997-10-17 2004-08-16 DESCRIPTION PRODUCT COVERED: * Component - Switching Power Supply, Medical and Dental, Models GLM75-X where X is any number from 5 thru 28. May or may not be followed by -L and/or -V. ELECTRICAL RATINGS: *Input: Output: 100-240 V ac, 3.0 A, 50/60 Hz 5 thru 28 V, 20 thru 4 A 70 W max for output voltages from 5 thru 11 V with convection cooling 75 W max for output voltages from 12 thru 28 V with convection cooling 100 W max for output voltages from 5 thru 11 V with 26 CFM forced air cooling 110 W max for output voltages from 12 thru 28 V with 26 CFM forced air cooling ENGINEERING CONSIDERATIONS (NOT FOR FIELD REPRESENTATIVE’S USE: For use in product where the acceptability of the combination is determined by Underwriters Laboratories Inc. This product was evaluated to the First Edition of the Standard For Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1. An Insulation Diagram is provided as ILL. 1. File E116994 Vol. 1 Sec. 50 and Report Page 2 Issued: Revised: 1997-10-17 2004-08-16 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 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. 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, without forced air cooling with a 75 W output load condition, and with a 26 CFM fan, 2.1 in. above unit center, blowing down with a 110 W output load condition. 8. The main isolation transformer, T3, complies with Class 155°C 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; basic insulation between primary to ground; and operational insulation only between secondary to ground. File E116994 Vol. 1 Sec. 50 and Report Page 3 Issued: 1997-10-17 11. The power supplies have been evaluated as Class I, continuous operation, ordinary equipment and have not been evaluated for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide. 12. Fusing in the end-product shall be considered since primary fusing of both sides on the mains supply line was not provided (3.5 A fuse provided on input line side). 13. Under normal and single fault conditions, the outputs do not exceed 25 V ac or 60 V dc. Statement of Compliance Condor Report: 230 Master Contract: 150684 (LR 46516C) Edition: 2 Date Issued: August 11, 2004 Issued by: Condor D.C. Power Supplies Inc. 2311 Statham Parkway Oxnard, CA 93033 USA The products listed below are eligible to bear the CSA Mark shown Issued by: Ross Sacolles Signature: PRODUCTS CLASS 5311 20 - POWER SUPPLIES - For Use in Medical Equipment Component Power Supply for use in Medical Equipment, where the suitability of the combination is to be determined by CSA International. MODEL NUMBERS: Model GLM75–X where X represents the output voltage, which may be any number from 5 thru 28. Models may be followed by suffix –L for chassis bracket. Input: Output: 100-240 V ac, 3.0 A, 50/60 Hz 5 thru 28 V, 20 thru 4 A (L3M1) 70 W maximum for output voltages from 5 thru 11 V with convection cooling 75 W maximum for output voltages from 12 thru 28 V with convection cooling 100 W maximum for output voltages from 5 thru 11 V with 26 CFM forced air cooling 110 W maximum for output voltages from 12 thru 28 V with 26 CFM forced air cooling Notes: 1. Maximum Operating Ambient Temperature 50 °C. 2. Maximum Operating Relative Humidity 96 %, no condensation. 3. Storage: -40 to +85 °C. Units should be allowed to warm-up under non-condensing conditions before application of power. This is to certify that the equipment indicated above has been tested, evaluated and found to comply to all relevant CSA International requirements. This equipment is eligible to bear the CSA Mark as authorized by the CSA Category Certification Program under Master Contract No. 150684 (LR 46516C). Page 1 Condor Report: 230 Edition: 2 Master Contract: 150684 (LR 46516C) Date: August 11, 2004 APPLICABLE REQUIREMENTS CAN/CSA Standard C22.2 No. 601.1-M90 - Medical Electrical Equipment CONDITIONS OF ACCEPTABILITY 1. This component has been judged on the basis of the required spacings in the Standard for Medical Electrical equipment, Part 1: General Requirements for Safety, CAN/CSA-C22.2 No. 601.1-M90, which covers the end-use product for which the component is designed. 2. The enclosure provided with this equipment does not meet the applicable requirements for Fire or Electrical enclosures. Suitable enclosure to be provided in the end-use equipment. 3. 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 equipment. 4. The main isolation transformer (T3) is provided with Class F insulation. 5. The output circuits have not been evaluated for direct patient connection (Type B, BF or CF). 6. The power supply has been evaluated for patient care equipment, but not patient connected. 7. The temperature tests were performed in a raised ambient of 50 °C. 8. The power supply was evaluated for Reinforced insulation between primary and secondary, and Basic insulation between primary and ground, based on min 250 V ac. 9. The power supply has been evaluated as Class I equipment, 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. 10. Under normal and single fault conditions, the outputs do not exceed 25 V ac or 60 V dc. 11. The internal fuse is located in the phase lead only. CAN/CSA-C22.2 No. 601.1-M90 requires that both supply leads (phase and neutral) be protected against overcurrent except for permanently installed equipment. Complete overcurrent protection must be provided in the end-use equipment. Fuse ratings must not exceed that specified for the internal fuse. Page 2 Supplement to Statement of Compliance Condor Report: 230 Master Contract: 150684 (LR 46516C) Edition: 2 Issued by: Condor D.C. Power Supplies Inc. 2311 Statham Parkway Oxnard, CA 93033 USA Issued by: Ross Sacolles Signature: The products listed, including the latest revision described below, are eligible to be marked in accordance with the referenced Certificate. CSA Category Certification Product History Record Edition Date Description 1 July 25, 2002 Original Certification. (Re-issued Report LR 46516-259C/Report No. 1113663 Edition 1/Condor Report No. 162 Rev. D as Condor Report No. 230 Edition 1, updated to revise model designations, and upgrade to CSA 601.1-M90). 2 August 11, 2004 CSA Reviews Deleted Model MSP1690 and updated transformer construction with 2L – Kapton or Tefzel magnet wires. 3 4 Page 1