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Address ...........................................: #805, Manhatan Building, 36-2 Yeouido-Dong, Yeongdeungpo-Gu, Seoul 150-749, Korea Applicants name ............................: BRIDGEPOWER CORP Address ...........................................: 964 GOSAEK-DONG GWONSEON-GU SUWON-SI GYEONGGI-DO 441-813 KOREA Test specification: Standard ..........................................: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Test procedure................................: CB Scheme Non-standard test method ..: N/A Test Report Form No......................: IEC60601_1G Test Report Form Originator .........: Underwriters Laboratories Inc. Master TRF ......................................: Dated 2010-11 Copyright © 2010 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo shall be removed This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. Test item description .................... : Medical Power Supply Trade Mark ..................................... : None Manufacturer.................................. : BRIDGEPOWER CORP 964 GOSAEK-DONG GWONSEON-GU SUWON-SI GYEONGGI-DO 441-813 KOREA Page 2 of 233 Model/Type reference.................... : Report No. E302267-20110526 BP(a)040(b)(c)(d)(e) (a) can be A to Z for family related designs. (b) can be S for single. (c) can be 05, 09, 12, 15, 18, 24 or 48 for output voltage. (d) can be F or N or Q for input plug type. (e) can be 00 thru 99 for customer options, not related safety concerns. (a)ENB1040(b)(c)(d)(e)(f) (a) can be A to Z for family related designs. (b) can be A to Z for design revision changes. (c) can be 05, 09, 12, 15, 18, 24 or 48 for output voltage. (d) can be 00 thru 99 for standard output cord options. (e) can be F or N or Q for input plug type. (f) can be 00 thru 99 for customer options, not related safety concerns. Ratings............................................ : Rated Input; 100-240Vac, 50-60Hz, 1.2 A. Rated Output; 5Vdc, 5.0A or 9Vdc, 4.0A or 12Vdc, 3.4A or 15Vdc, 2.7A or 18Vdc, 2.2A or 24Vdc, 1.7A or 48Vdc, 0.83A. (Rated output voltage is designated in the model name designation system). TRF No. IEC60601_1G UL International Demko A/S Page 3 of 233 Report No. E302267-20110526 Testing procedure and testing location: CB Testing Laboratory: Testing location/ address................... : UL Korea, Ltd / #805, Manhatan Building, 36-2 Yeouido-Dong, Yeongdeungpo-Gu, Seoul 150-749, Korea Associated CB Test Laboratory: Testing location/ address................... : Tested by (name + signature).. : KiSoo Ahn Approved by (+ signature) ....... : ChanYo Won Testing procedure: TMP Tested by (name + signature).. : Approved by (+ signature) ........ : Testing location/ address................... : Testing procedure: WMT Tested by (name + signature).. : Witnessed by (+ signature)....... : Approved by (+ signature) ....... : Testing location/ address................... : Testing procedure: SMT Tested by (name + signature).. : Approved by (+ signature) ....... : Supervised by (+ signature) .... : Testing location/ address................... : Testing procedure: RMT Tested by (name + signature).. : Approved by (+ signature) ....... : Supervised by (+ signature) .... : Testing location/ address................... : TRF No. IEC60601_1G UL International Demko A/S Page 4 of 233 Report No. E302267-20110526 List of Attachments (including a total number of pages in each attachment): - Photographs (7 pages) - Schematics + PWB (20 pages) - Miscellaneous (6 pages) - Marking Plate (4 pages) Summary of testing Tests performed (name of test and test clause): Testing location: Testing of this AC-DC Adaptor was not considered necessary based on the results of previous investigations to IEC 60601-1 Second Edition and IEC 60950-1 Second Edition. N/A Summary of compliance with National Differences List of countries addressed: See Technical Consideration for details. The product fulfils the requirements of IEC 60601-1 Third Edition. Copy of marking plate Refer to Attachment titled Marking Plate for copy TRF No. IEC60601_1G UL International Demko A/S Page 5 of 233 Report No. E302267-20110526 GENERAL INFORMATION Test item particulars (see also Clause 6): Classification of installation and use ................................. : Hand-held or Portable Device type (component/sub-assembly/ equipment/ system) ................................................................................... : Component power supply Intended use (Including type of patient, application location).................................................................................. : To supply regulated power. Mode of operation ................................................................ : Continuous Supply connection ............................................................... : Appliance inlet Accessories and detachable parts included ...................... : None Other options include ........................................................... : None Testing Date of receipt of test item(s)................................................ : 2011-02-07(E300305-A57-CB-1), 2011-02-09(E302267-A33-CB-1) Dates tests performed ........................................................... : 2011-02-07 to 2011-02-11 (E300305-A57-CB-1), 2011-02-09 to 2011-02-14 (E302267-A33-CB-1) Possible test case verdicts: - test case does not apply to the test object ...................: N/A - test object does meet the requirement ...........................: Pass (P) - test object was not evaluated for the requirement.......... : N/E - test object does not meet the requirement ....................: Fail (F) Abbreviations used in the report: - normal condition ...................................................: N.C. - single fault condition................... : S.F.C. - means of Operator protection .............................: MOOP - means of Patient protection ...... : MOPP General remarks: "(see Attachment #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report. The tests results presented in this report relate only to the object tested. This report shall not be reproduced except in full without the written approval of the testing laboratory. List of test equipment must be kept on file and available for review. Additional test data and/or information provided in the attachments to this report. Throughout this report a TRF No. IEC60601_1G comma / point is used as the decimal separator. UL International Demko A/S Page 6 of 233 Report No. E302267-20110526 Manufacturers Declaration per sub-clause 6.2.5 of IECEE 02: The application for obtaining a CB Test Certificate includes more than one factory location and a declaration from the Manufacturer stating that the sample(s) submitted for evaluation is (are) representative of the products from each factory has been provided...................................................... : Yes Not applicable When differences exist; they shall be identified in the General product information section. Name and address of factory (ies)......................... : BRIDGEPOWER CORP 964 GOSAEK-DONG GWONSEON-GU SUWON-SI GYEONGGI-DO 441-813 KOREA WENDENG JEIL ELECTRONICS CO LTD DONG SHOU GUANGZHOU LU KAIFA-QU WENDENG-SHI SHANDONG CHINA TRF No. IEC60601_1G UL International Demko A/S Page 7 of 233 Report No. E302267-20110526 General product information: Products are component power supplies intended to be used as part of Medical Electrical Equipment. This AC Input Power Supply provide MOOP isolation from Primary to Secondary and/or MOOP isolation from Primary to Earth. It contains the mains transformer with UL Recognized Insulation System. This product is the AC-DC Adaptor of the switching type power supply, which electronic components are mounted on PWB and housed in plastic enclosure and provided with appliance inlet. In addition, some series of power supply are the direct plug-in units. See "Model Differences" for details. Model Differences - The BPM040 series is the basic model. Model (a)ENB1040 series is identical to the basic model series except for the model type designations. - The marked models as 05, 09, 12, 15, 18, 24 and 48 on nomenclature are similar, except for Main transformer (T1) windings, output rating and minor secondary circuit options not affecting safety. -For each plug-type configuration F-Class I appliance inlet type: IEC60320-C14, Q-Class II appliance inlet type: IEC60320-C18, N-Class II appliance inlet type: IEC60320-C8. Additional Information Testing was not considered necessary based upon previous evaluation under CB Scheme. The CB Scheme Test Certificate and Report Ref. No. (E302267-A33-CB-1 under CB Certificate No. DK-22050) and (E300305-A57-CB-1 under CB Certificate No. DK-2371). Max. Normal Load Condition: Rated output current Technical Considerations The product was investigated to the following additional standards: ANSI/AAMI ES606011:2005/C1:2009 (includes National Differences for USA); CAN/CSA-C22.2 No. 60601-1:08 (includes National Differences for Canada), EN 60601-1:2006 Scope of Power Supply evaluation defers the following clauses to the be determined as part of the end product: Clause 7.5 (Safety Signs), Clause 7.9 (Accompanying Documents), Clause 9 (Mechanical Hazard), Clause 10 (Radiation), Clause 14 (PEMS), Clause 16 (ME Systems) Scope of Power Supply evaluation excludes the following: - Patient applied parts clauses: 4.6, 7.2.10, 8.3, 8.5.2, 8.5.5, 8.7.4.7-8.7.4.9, 8.9.1.15 - Battery related clauses: 7.3.3, 15.4.3 - Hand Control related clauses: 8.10.4 - Oxygen related clauses: 11.2.2 - Fluids related clauses: 11.6.2 11.6.4 - Sterilization clause: 11.6.7 - Biocompatibility Clause: 11.7 (ISO 10993) - Motor related clauses: 13.2.13.3, 13.4 - Heating Elements related clause: 13.2 TRF No. IEC60601_1G UL International Demko A/S