SPECIFIC TECHNICAL CRITERIA

Transcription

1 Issue Date: Page 1 of 8 Report Reference # E A1-UL-1 SPECIFIC TECHNICAL CRITERIA TEST REPORT UL Medical Electrical Equipment Part 1: General requirements for safety Report Reference No...: E A1-UL-1 Compiled by...: Dean Klubnik Reviewed by...: Michael J. Howell 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...: Switching Power Supply Trademark...: Model and/or type reference...: HFS150A-5, HFS150A-12, HFS150A-15, HFS150A-24, HFS150A-30, HFS150A-48 Rating(s)...: Input: See Model Differences Output: See Model Differences

2 Issue Date: Page 2 of 8 Report Reference # E A1-UL-1 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: Building-in Building-in 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 The equipment (power supply) 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 HFS150A series is designed for building-in to an end product. CC1.0 CC1.1 Model Differences HFS150A-5: Input: 1.4 A, V~, 50/60 Hz; Output: 5 Vdc, 20 A HFS150A-12: Input: 2.0 A, V~, 50/60 Hz; Output: 12 Vdc, 12.5 A HFS150A-15: Input: 2.0 A, V~, 50/60 Hz; Output: 15 Vdc, 10 A

3 Issue Date: Page 3 of 8 Report Reference # E A1-UL-1 HFS150A-24: Input: 2.0 A, V~, 50/60 Hz; Output: 24 Vdc, 6.3 A HFS150A-30: Input: 2.0 A, V~, 50/60 Hz; Output: 30 Vdc, 5.0 A HFS150A-48: Input: 2.0 A, V~, 50/60 Hz; Output: 48 Vdc, 3.2 A Differences betweeen the models are the construction of Transformer T301 by the number of turns on the S1 and S2 windings. Additionally, please see the Temperature/Installation Conditions in Miscellaneous Enclosure 02 CD1.0 CD1.1 Additional Information Correction 1: Modified the critical components list to indicate that optical isolators (PC501, PC502, PC503) only require the UL recognition mark. Amendment 1: Added models HFS150A-5, HFS150A-12, HFS150A-15, HFS150A-24 and HFS150A-48 per Nemko Report # and revisions to Temperature/Installation Conditions table per Nemko Report # Correction 2: Corrected Critical Component List and Temperature Loading Configuration for Model HFS150A-30 with cover in Miscellaneous Enclosre CE1.0 CE1.1 CE1.2 CE1.3 CE1.4 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: UL , 1st Edition, (includes National Differences for USA), (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 CE1.6 The mode of operation is: Continuous CE1.7 CE1.8 Software is relied upon for meeting safety requirements related to mechanical, fire and shock: The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide: No No

4 Issue Date: Page 4 of 8 Report Reference # E A1-UL-1 CF1.0 CF1.1 CF2.0 CF2.1 CF2.2 CF2.3 CF2.4 CF2.5 CF2.6 CF2.7 CF2.8 Engineering Conditions of Acceptability For use only in or with complete equipment where the acceptability of the combination is determined by When installed in an end-product, consideration must be given to the following: The power supplies have 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 and CSA C22.2 No M90, which covers the end use product for which the component is designed. The device shall be installed in compliance with the enclosure, mounting, spacing, casualty markings, and segregation requirements of the end-use application. The Temperature Test was performed in various ambients with various loading and installation. 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. Please refer to Miscellaneous Enclosure 02 for a table depicting results tested. Consideration should be given to retesting the power supply if it is loaded, installed, or used in temperatures that are different from what is detailed in the diagram The input and 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 acceptability of these in the mating connectors relative to secureness, insulating materials, and temperature shall be considered. The power supply should be properly bonded to Protective Earth in the end-use product. The power supply has been evaluated for patient care equipment, but not patient connected. The output circuits have not been evaluated for direct patient connection (Type B, BF, or CF). Leakage current testing should be repeated in the end product application. The power supplies were evaluated as Reinforced insulation between primary and secondary; basic insulation between primary to ground; and operational insulation only between secondary to ground.

5 Issue Date: Page 5 of 8 Report Reference # E A1-UL-1 CF2.9 CF3 CF3.1 The power supplies have 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. Fusing in the end product shall be considered since only one UL Recognized fuse rated T5AH, 250 V, fast-blow is provided in the hot side of the input supply circuit. The outputs of the power supplies do not exceed 25 V ac or 60 V dc under normal and single fault conditions. CF3.2 Capacitance Discharge testing of Clause 15b) should be repeated in the end product application.