AC/DC Medical Adapter. DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY, Taiwan

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1 Ref. Certif. No. DK M1-UL IEC SYSTEM FOR MUTUAL RECOGNITION OF TEST CERTIFICATES FOR ELECTRICAL EQUIPMENT (IECEE) CB SCHEME SYSTEME CEI D'ACCEPTATION MUTUELLE DE CERTIFICATS D'ESSAIS DES EQUIPEMENTS ELECTRIQUES (IECEE) METHODE OC CB TEST CERTIFICATE Product Produit Name and address of the applicant Nom et adresse du demandeur Name and address of the manufacturer Nom et adresse du fabricant Name and address of the factory Nom et adresse de l'usine Note: When more than one factory, please report on page 2 Note: Lorsque il y plus d'une usine, veuillez utiliser la 2 ème page Ratings and principal characteristics Valeurs nominales et caractéristiques principales Trademark (if any) Marque de fabrique (si elle existe) CERTIFICAT D'ESSAI OC AC/DC Medical Adapter DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY, Taiwan DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY, Taiwan DELTA ELECTRONICS (JIANGSU) LTD. NO 1688 JIANGXING EAST RD WUJIANG ECONOMIC DEVELOPMENT ZONE WUJIANG CITY, JIANGSU PROVINCE China Additional Information on page 2 Input rating: 100 ~ 240Vac; 2.5-1A; Hz Output rating: MDS-150AAS12 B: 12Vdc, 10A MDS-150AAS19 B: 19Vdc, 7.89A MDS-150AAS24 B: 24Vdc, 6.25A Delta Type of Manufacturer's Testing Laboratories used Type de programme du laboratoire d'essais constructeur Model / Type Ref. Ref. De type Additional information (if necessary may also be reported on page 2) Les informations complémentaires (si nécessaire,, peuvent être indiqués sur la 2 ème page A sample of the product was tested and found to be in conformity with Un échantillon de ce produit a été essayé et a été considéré conforme à la As shown in the Test Report Ref. No. which forms part of this Certificate Comme indiqué dans le Rapport d'essais numéro de référence qui constitue partie de ce Certificat WMT MDS-150AAS12 B, MDS-150AAS19 B, MDS-150AAS24 B National Differences specified in the CB Test Report. Additional Information on page 2 IEC (ed.3) E A4-CB-1 issued on This CB Test Certificate is issued by the National Certification Body Ce Certificat d'essai OC est établi par l'organisme National de Certification Date: Original Issue Date: Signature: UL (US), 333 Pfingsten Rd IL 60062, Northbrook, USA UL (Demko), Borupvang 5A DK-2750 Ballerup, DENMARK UL (JP), Marunouchi Trust Tower Main Building 6F, Marunouchi, Chiyoda-ku, Tokyo , JAPAN UL (CA), 7 Underwriters Road, Toronto, M1R 3B4 Ontario, CANADA For full legal entity names see Jan-Erik Storgaard rd 1/2

2 Ref. Certif. No. DK M1-UL Factories: DELTA ELECTRONICS (THAILAND) PUBLIC CO LTD 909 SOI 9, MOO 4,PATTANA 1RD BANGPOO INDUSTRIAL ESTATE (E P Z) TAMBOL PHRAKSA AMPHUR MUANG SAMUTPRAKARN, Thailand DELTA ELECTRONICS POWER (DONGGUAN) CO LTD DELTA INDUSTRIAL ESTATE SHIJIE TOWN DONGGUAN, GUANGDONG China Additional Information: This is a correction to CB Test Certificate to revise the trademark. Additional information (if necessary) Information complémentaire (si nécessaire) UL (US), 333 Pfingsten Rd IL 60062, Northbrook, USA UL (Demko), Borupvang 5A DK-2750 Ballerup, DENMARK UL (JP), Marunouchi Trust Tower Main Building 6F, Marunouchi, Chiyoda-ku, Tokyo , JAPAN UL (CA), 7 Underwriters Road, Toronto, M1R 3B4 Ontario, CANADA For full legal entity names see Date: Original Issue Date: Signature: Jan-Erik Storgaard 2/2

3 Ref. Certif. No. DK UL IEC SYSTEM FOR MUTUAL RECOGNITION OF TEST CERTIFICATES FOR ELECTRICAL EQUIPMENT (IECEE) CB SCHEME SYSTEME CEI D'ACCEPTATION MUTUELLE DE CERTIFICATS D'ESSAIS DES EQUIPEMENTS ELECTRIQUES (IECEE) METHODE OC CB TEST CERTIFICATE Product Produit Name and address of the applicant Nom et adresse du demandeur Name and address of the manufacturer Nom et adresse du fabricant Name and address of the factory Nom et adresse de l'usine Note: When more than one factory, please report on page 2 Note: Lorsque il y plus d'une usine, veuillez utiliser la 2 ème page Ratings and principal characteristics Valeurs nominales et caractéristiques principales Trademark (if any) Marque de fabrique (si elle existe) CERTIFICAT D'ESSAI OC AC/DC Medical Adapter DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY, Taiwan DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY, Taiwan DELTA ELECTRONICS (JIANGSU) LTD. NO 1688 JIANGXING EAST RD WUJIANG ECONOMIC DEVELOPMENT ZONE WUJIANG CITY, JIANGSU PROVINCE China Additional Information on page 2 Input rating: 100 ~ 240Vac; 2.5-1A; Hz Output rating: MDS-150AAS12 B: 12Vdc, 10A MDS-150AAS19 B: 19Vdc, 7.89A MDS-150AAS24 B: 24Vdc, 6.25A Delta Type of Manufacturer's Testing Laboratories used Type de programme du laboratoire d'essais constructeur Model / Type Ref. Ref. De type Additional information (if necessary may also be reported on page 2) Les informations complémentaires (si nécessaire,, peuvent être indiqués sur la 2 ème page A sample of the product was tested and found to be in conformity with Un échantillon de ce produit a été essayé et a été considéré conforme à la As shown in the Test Report Ref. No. which forms part of this Certificate Comme indiqué dans le Rapport d'essais numéro de référence qui constitue partie de ce Certificat WMT MDS-150AAS12 B, MDS-150AAS19 B, MDS-150AAS24 B National Differences specified in the CB Test Report. Additional Information on page 2 IEC (ed.3) E A4-CB-1 issued on This CB Test Certificate is issued by the National Certification Body Ce Certificat d'essai OC est établi par l'organisme National de Certification Date: Signature: UL (US), 333 Pfingsten Rd IL 60062, Northbrook, USA UL (Demko), Borupvang 5A DK-2750 Ballerup, DENMARK UL (JP), Marunouchi Trust Tower Main Building 6F, Marunouchi, Chiyoda-ku, Tokyo , JAPAN UL (CA), 7 Underwriters Road, Toronto, M1R 3B4 Ontario, CANADA For full legal entity names see Jan-Erik Storgaard rd 1/2

4 Ref. Certif. No. DK UL Factories: DELTA ELECTRONICS (THAILAND) PUBLIC CO LTD 909 SOI 9, MOO 4,PATTANA 1RD BANGPOO INDUSTRIAL ESTATE (E P Z) TAMBOL PHRAKSA AMPHUR MUANG SAMUTPRAKARN, Thailand DELTA ELECTRONICS POWER (DONGGUAN) CO LTD DELTA INDUSTRIAL ESTATE SHIJIE TOWN DONGGUAN, GUANGDONG China Additional information (if necessary) Information complémentaire (si nécessaire) UL (US), 333 Pfingsten Rd IL 60062, Northbrook, USA UL (Demko), Borupvang 5A DK-2750 Ballerup, DENMARK UL (JP), Marunouchi Trust Tower Main Building 6F, Marunouchi, Chiyoda-ku, Tokyo , JAPAN UL (CA), 7 Underwriters Road, Toronto, M1R 3B4 Ontario, CANADA For full legal entity names see Date: Signature: Jan-Erik Storgaard 2/2

5 Issue Date: Page 1 of 9 Report Reference # E A5-CB-1 Test Report issued under the responsibility of: TEST REPORT IEC Medical Electrical Equipment Part 1:General requirements for basic safety and essential performance Report Reference No... : E A5-CB-1 Date of issue... : Total number of pages... : 9 CB Testing Laboratory... : Address... : Applicant's name... : Address... : Test specification: Underwriters Laboratories Taiwan Co., Ltd. 260 Da-Yeh Road, 112 Peitou Taipei City, Chinese Taipei DELTA ELECTRONICS INC 3 TUNGYUAN RD CHUNGLI INDUSTRIAL ZONE TAOYUAN COUNTY TAIWAN Standard... : IEC : CORR. 1 (2006) + CORR. 2 (2007) Test procedure... : Non-standard test method... : Test Report Form No.... : Test Report Form originator... : CB Scheme N/A IEC60601_1G UL LLC Master TRF... : Dated 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 is used by non-iecee members, the IECEE/IEC logo and the reference to the CB Scheme procedure 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.

6 Issue Date: Page 2 of 9 Report Reference # E A5-CB-1 Test item description... : Trade Mark... : SWITCHING POWER SUPPLY DELTA ELECTRONICS INC. Manufacturer... : Model/Type reference... : Ratings... : DELTA ELECTRONICS, INC. 3 TUNGYUAN ROAD, CHUNGLI INDUSTRIAL ZONE, TAOYUAN COUNTY 32063, TAIWAN, R.O.C. MDS-065APS12 B MDS-065APS15 B MDS-065APS18 B MDS-065APS24 B Input rating: Vac; A; Hz Output rating (Full load): MDS-065APS12 B 12Vdc, 5.42A MDS-065APS15 B 15Vdc, 4.2A MDS-065APS18 B 18Vdc, 3.61A MDS-065APS24 B 24Vdc, 2.71A When ambient 50 degree C - output full load, ambient 70 degree C - output half load

7 Issue Date: Page 3 of 9 Report Reference # E A5-CB-1 Testing procedure and testing location: [x] CB Testing Laboratory [ ] Associated CB Test Laboratory Tested by (name + signature)... : Underwriters Laboratories Taiwan Co., Ltd. 260 Da-Yeh Road, 112 Peitou Taipei City, Chinese Taipei Fiona Tsai Approved by (name + signature)... : David Shih [ ] Testing Procedure: TMP Tested by (name + signature)... : Approved by (+ signature)... : [ ] Testing Procedure: WMT Tested by (name + signature)... : Witnessed by (+ signature)... : Approved by (+ signature)... : [ ] Testing Procedure: SMT Tested by (name + signature)... : Approved by (+ signature)... : Supervised by (+ signature)... : [ ] Testing Procedure: RMT Tested by (name + signature)... : Approved by (+ signature)... : Supervised by (+ signature)... : List of Attachments National Differences (3 pages) Enclosures (0 pages) Summary of Testing: No tests were conducted Summary of Compliance with National Differences: Countries outside the CB Scheme membership may also accept this report. List of countries addressed: AT, BE, CA, CH, CZ, DE, DK, FI, FR, GB, HU, IL, IT, NL, NO, PL, SE, SG, SI, SK, TR, UA, US

8 Issue Date: Page 4 of 9 Report Reference # E A5-CB-1 The product fulfills the requirements of: CSA C22.2 NO MEDICAL ELECTRICAL EQUIPMENT. PT. 1, GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - Edition 2 - Revision Date 2011/06/01 Copy of Marking Plate - Refer to Enclosure titled Marking Plate for copy.

9 Issue Date: Page 5 of 9 Report Reference # E A5-CB-1 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: Component, shall be evaluate in end product Component Switching power supply intended to medical use Continuous Input terminal None None N/A N/A - test case does not apply to the test object... : N / A - test object does meet the requirement... : P(Pass) - test object was not evaluated for the requirement : N / E - test object does not meet the requirement... : F(Fail) 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 test 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 point is used as the decimal separator. Manufacturer's Declaration per Sub Clause 6.25 of IECEE 02: The application for obtaining a CB Test Certificate includes more than one factory and a declaration form the Manufacturer stating that the sample(s) submitted for evaluation is (are) representative of the products from each factory has been provided... Yes When differences exist, they shall be identified in the General Product Information section. Name and address of Factory(ies): DELTA ELECTRONICS (JIANGSU) LTD. NO. 1688, JIANGXING EAST ROAD, WUJIANG ECONOMIC DEVELOPMENT ZONE, WUJIANG CITY, JIANGSU PROVINCE, CHINA DELTA ELECTRONICS (THAILAND) PUBLIC CO., LTD.

10 Issue Date: Page 6 of 9 Report Reference # E A5-CB SOI 9 MOO 4, BANGPOO INDUSTRIAL ESTATE (E.P.Z.), PATTANA 1 RD., TAMBOL PHRAKSA, AMPHUR MUANG, SAMUTPRAKARN 10280, THAILAND DELTA ELECTRONICS POWER (DONGGUAN) CO., LTD. DELTA INDUSTRIAL ESTATE, SHIJIE TOWN, DONGGUAN CITY, GUANGDONG PROVINCE CHINA GENERAL PRODUCT INFORMATION: Report Summary The original report was modified on to include the following changes/additions: Add EN standard. No test required. E A5-CB-1 original report issued with CB Certificate No. (DK UL.) issued on Product Description The equipments are Class I AC/DC open frame switching power supply intended for supplying medical electrical equipment, and unit are consisting of electrical components mounted on print wiring board. Model Differences Models MDS-065APS12 B, MDS-065APS15 B, MDS-065APS18 B and MDS-065APS24 B are similar construction in primary circuit design and differ in sources of main transformer T1 and ratings of primary component (see enclosure 7-02 for details). MDS-065APS12 B and MDS-065APS15 B use the identical transformer. The different of secondary components are related output voltage set-up and output control. See appended Enclosure 7-02 for compare detail. Output: (Vdc)/ (A) MDS-065APS12 B: 12 / 2.71 MDS-065APS15 B: 15 / 3.61 MDS-065APS18 B: 18 / 4.2 MDS-065APS24 B: 24/ 5.42 Additional Information Revision (12CA60113) Add EN standard. No test required. **************************************************************************************************************************** ************ Risk Management report and file, according to ISO/IEC 14971: 2000, were provided by client. The document were reviewed to meet the requirements of ISO/IEC 14971:2000, and also the requirements of IEC Third Edition, ANSI/AAMI ES First Edition, and CAN/CSA-C22.2 No :08 Second Edition.