SPECIFIC TECHNICAL CRITERIA

Transcription

1 Issue Date: Page 1 of 5 Report Reference # E A5-UL-1 SPECIFIC TECHNICAL CRITERIA TEST REPORT UL Medical Electrical Equipment Part 1: General requirements for safety Report Reference No...: E A5-UL-1 Compiled by...: Ayako Ikeda Reviewed by...: Yoshio Kitamura 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...: Test item description...: Component Power Supplies Trademark...: Model and/or type reference...: HWS100-5/ME or /MEA HWS100-12/ME or /MEA HWS100-15/ME or /MEA HWS100-24/ME or /MEA HWS100-48/ME or /MEA (where ME is without frame and MEA is the addition of a honeycomb frame) Rating(s)...: HWS100-5/ME or /MEA Output: 5V 20A (4-6V) HWS100-12/ME or /MEA Output: 12V 8.5A ( V) HWS100-15/ME or /MEA Output: 15V 7A (12-18V)

2 Issue Date: Page 2 of 5 Report Reference # E A5-UL-1 HWS100-24/ME or /MEA Output: 24V 4.5A ( V) HWS100-48/ME or /MEA Output: 48V 2.1A ( V)

3 Issue Date: Page 3 of 5 Report Reference # E A5-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: Fixed Permanently installed 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 CB1.0 CB1.1 Product Description Component Power Supply. No Applied Part CC1.0 CC1.1 Model Differences CD1.0 CD1.1 Additional Information

4 Issue Date: Page 4 of 5 Report Reference # E A5-UL-1 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: CAN/CSA C22.2 No M90 (R1997), CAN/CSA C22.2 No S1-94, and CAN/CSA C22.2 No B-98 (National Differences for Canada) Clause 52.1, Programmable Electronic Systems (IEC ), Clause 48, Biocompatibility (ISO ), Clause 36, Electromagnetic Compatibility (IEC ) Shock, Fire, Casualty 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 CF1.0 CF1.1 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: CF1.2 Note: No default COAs exist for 60601, CF2.0 CF2.1 CF2.2 It should be noted that the power supplies have been assessed as a component part., It is the installer's responsibility to ensure that the final installation is in accordance with, the Densei-Lambda HWS /ME Series Instruction Manual, the relevant, specifications sheets and that it is in compliance with IEC The Power Supplies detailed in this Report were rated, by the Client, for Basic, insulation requirements between the mains input and DC outputs, with respect to IEC, /EN applications., The residual voltage retained by internal components was found to drop below the limit of 60V dc 1 minute after disconnection of the

5 Issue Date: Page 5 of 5 Report Reference # E A5-UL-1 CF2.3 CF2.4 CF2.5 CF2.6 CF2.7 supply., Access time, for a service engineer, must therefore be taken into consideration for the, installation, to ensure compliance with IEC /EN Sub-clause 15c. During this submission the client modified the PSU as follows:, a. The voltage range has been limited to V for EN applications, b. The symbol is now on the rating label., c. The word 'max' has now been placed adjacent to the current consumption., d. The user manual has now been modified to Version Dwg no: A /ME The suffix ME has been added to the rating label, Instruction manual and, specifications pages to identify the medical versions of this power supply. The leakage current test results as per section 19 were accepted incorporating 19.5DV.1. The power supplies MUST be enclosed within a nonconductive material. The equipment has been classified by the manufacturer for installation into a plastic enclosure to meet the leakage requirements of 19.5DV.1, Only equipment incorporating the above modifications can be considered to comply.,