ÜÕóîêéèìóËÔ ÝÞ ÌÛÍÌ ÝÛÎÌ×Ú×ÝßÌÛ ÝÛÎÌ×Ú×ÝßÌ ÜùÛÍÍß× ÑÝ É¸»² ³±®» ¬¸¿² ±²» º¿½¬±®§ô °´»¿-» ®»°±®¬ ±² °¿¹» î Ô±®-¯«» ·´ § °´«- ¼ù«²» «-·²»ô ª»«·´´»¦ «¬·´·-»® ´¿ î8³» °¿¹» Ò¿¬·±²¿´ ¼» Ý»®¬·º·½¿¬·±² Ú±® º«´´ ´»¹¿´ »²¬·¬§ ²¿³»- -»» ©©©ò«´ò½±³ñ²½¾²¿³»- ÜÕóîêéèìóËÔ ß¼¼·¬·±²¿´ ·²º±®³¿¬·±² ø·º ²»½»--¿®§÷ ײº±®³¿¬·±² ½±³°´7³»²¬¿·®» ø-· ²7½»--¿·®»÷ Ú±® º«´´ ´»¹¿´ »²¬·¬§ ²¿³»- -»» ©©©ò«´ò½±³ñ²½¾²¿³»- Test Report issued under the responsibility of: 12 IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Report Reference No......................: Date of issue ...................................: Total number of pages...................: CB Testing Laboratory...................: Address ...........................................: Applicants name ............................: Address ...........................................: Test specification: Standard ..........................................: IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Test procedure................................: CB Scheme Non-standard test method ..: Test Report Form No......................: IEC60601_1G Test Report Form Originator .........: Underwriters Laboratories Inc. Master TRF ......................................: Dated 2010-11 Test item description .................... : Trade Mark ..................................... : Manufacturer.................................. : Model/Type reference.................... : Page 2 of 309 Ratings............................................ : Report No. E302267-12CA23553 Page 3 of 309 Testing procedure and testing location: CB Testing Laboratory: Testing location/ address................... : Associated CB Test Laboratory: Testing location/ address................... : Tested by (name + signature) .. : DongGug Cho Approved by (+ signature) ....... : DongYoul Kim 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................... : Report No. E302267-12CA23553 Page 4 of 309 Report No. E302267-12CA23553 List of Attachments (including a total number of pages in each attachment): Summary of testing Tests performed (name of test and test clause): Summary of compliance with National Differences Copy of marking plate - Testing location: Page 5 of 309 Report No. E302267-12CA23553 GENERAL INFORMATION Test item particulars (see also Clause 6): Classification of installation and use ................................. : Device type (component/sub-assembly/ equipment/ system) ................................................................................... : Intended use (Including type of patient, application location).................................................................................. : Mode of operation ................................................................ : Supply connection ............................................................... : Accessories and detachable parts included ...................... : Other options include ........................................................... : Testing Date of receipt of test item(s)................................................ : Dates tests performed ........................................................... : Possible test case verdicts: - test case does not apply to the test object ...................: - test object does meet the requirement ...........................: - test object was not evaluated for the requirement.......... : - test object does not meet the requirement ....................: Abbreviations used in the report: - normal condition ...................................................: N.C. - means of Operator protection .............................: MOOP General remarks: Throughout this report a comma / point is used as the decimal separator. Page 6 of 309 Report No. E302267-12CA23553 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)......................... : Page 7 of 309 General product information: Model Differences Technical Considerations Report No. E302267-12CA23553