Issue Date: 2009-06-15 Page 1 of 2 Report Reference # E254758-A21-UL-1 COVER PAGE FOR TEST REPORT Product Category: Product Category CCN: Test Procedure: Product: Model/Type Reference: Rating(s): Power Supplies, Medical and Dental QQHM2, QQHM8 Component Recognition AC/DC Power Adaptor DP4009N3M, DP4012N3M, DP4015N3M, DP4018N3M, DP4024N3M, DP4048N3M Input:100-240Vac, 50/60Hz, 1.0A, 49W Max. Output for Model DP4009N3M: +9 Vdc, 4.44 A Max. Output for Model DP4012N3M: +12 Vdc, 3.33 A Max. Output for Model DP4015N3M: +15 Vdc, 2.67 A Max. Output for Model DP4018N3M: +18 Vdc, 2.22 A Max. Output for Model DP4024N3M: +24 Vdc, 1.67 A Max. Output for Model DP4048N3M: +48 Vdc, 0.84 A Max. Standards: UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, Part 1: General Requirements for Safety) CAN/CSA-C22.2 No. 601.1-M90, 2005 (Medical Electrical Equipment - Part 1: General Requirements for Safety) Applicant Name and Address: ASTEC INTERNATIONAL LTD 16TH & 17TH FL LU PLAZA KWUN TONG, 2 WING YIP ST KOWLOON HONG KONG This Report includes the following parts, in addition to this cover page: 1. Specific Inspection Criteria 2. Specific Technical Criteria 3. Clause Verdicts 4. Critical Components 5. Test Results 6. Enclosures Copyright 2009
Issue Date: 2009-06-15 Page 4 of 72 Report Reference # E254758-A21-UL-1 SPECIFIC TECHNICAL CRITERIA TEST REPORT UL 60601-1 Medical Electrical Equipment Part 1: General requirements for safety Report Reference No... : E254758-A21-UL-1 Compiled by... : Calvin Tang Reviewed by... : Jimmy Deng Date of issue... : 2009-06-15 Standards...: UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, Part 1: General Requirements for Safety) CAN/CSA-C22.2 No. 601.1-M90, 2005 (Medical Electrical Equipment - Part 1: General Requirements for Safety) Test procedure...: Component Recognition Non-standard test method... : N/A Test item description... : AC/DC Power Adaptor Trademark... : None Model and/or type reference...: DP4009N3M, DP4012N3M, DP4015N3M, DP4018N3M, DP4024N3M, DP4048N3M Rating(s)...: Input:100-240Vac, 50/60Hz, 1.0A, 49W Max. Output for Model DP4009N3M: +9 Vdc, 4.44 A Max. Output for Model DP4012N3M: +12 Vdc, 3.33 A Max. Output for Model DP4015N3M: +15 Vdc, 2.67 A Max. Output for Model DP4018N3M: +18 Vdc, 2.22 A Max. Output for Model DP4024N3M: +24 Vdc, 1.67 A Max. Output for Model DP4048N3M: +48 Vdc, 0.84 A Max.
Issue Date: 2009-06-15 Page 5 of 72 Report Reference # E254758-A21-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: Recognized Power Supply Appliance coupler 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 These units are switching mode power supply, employs an appliance inlet for plugging in power supply cord (Not provided). A step down isolation transformer is used and all electronic components are mounted on PWB that rated V-0 and housed in plastic enclosure that rated V-0. Output cord is provided and the output plug is polarized and not standardized. CC1.0 CC1.1 Model Differences Model DP4012N3M is treated as basic model for testing. Model DP4009N3M is identical to Model DP4012N3M except for alternate output rating, transformer, trimming components and PWB layout. Model DP4015N3M is identical to Model DP4012N3M except for alternate output rating and
Issue Date: 2009-06-15 Page 6 of 72 Report Reference # E254758-A21-UL-1 transformer. Model DP4018N3M is identical to Model DP4012N3M except for alternate output rating, transformer and trimming components. Model DP4024N3M is identical to Model DP4012N3M except for alternate output rating and transformer. Model DP4048N3M is identical to Model DP4012N3M except for alternate output rating and transformer. CD1.0 CD1.1 Additional Information Amendment 1 details: To add additional Models DP4009N3M, DP4015N3M, DP4018N3M, DP4024N3M and DP4048N3M, see Model Differences for details. CE1.0 CE1.1 CE1.2 CE1.3 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: 1. UL 60601-1, 1st Edition, 2006-04-26 (includes National Differences for USA), 2. CAN/CSA-C22.2 No. 601.1-M90 (R2005) (includes National Differences for Canada) Clause 36, Electromagnetic Compatibility (IEC 601-1-2), Clause 48, Biocompatibility (ISO 10993-1), Clause 52.1, Programmable Electronic Systems (IEC 601-1-4) Casualty, Fire, Shock CE1.4 The degree of protection against harmful ingress Ordinary (IPX0) of water is: 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 CF2.0 When installed in an end-product, consideration must be given to the following: For use only in or with complete equipment where the acceptability of the combination is determined by Underwriters Laboratories Inc.When installed in an end-product, consideration must be given to the following: CF2.1 The equipment has not been evaluated for use in
Issue Date: 2009-06-15 Page 7 of 72 Report Reference # E254758-A21-UL-1 or likely to be used in the patient vicinity. CF2.2 The secondary output circuit is SELV. CF2.3 CF2.4 CF2.5 CF2.6 CF2.7 CF2.8 CF2.9 CF3 CF3.1 For Model DP4009N3M: The end-product Electric Strength Test is to be based upon a maximum working voltage of 263.5 Vrms, 937 Vpk-pk; For Model DP4012N3M: The upon a maximum working voltage of: 258 Vrms, 893 Vpk-pk; For Model DP4015N3M: The upon a maximum working voltage of: 261.7 Vrms, 893 Vpk-pk; For Model DP4018N3M: The upon a maximum working voltage of: 266.7 Vrms, 928 Vpk-pk; For Model DP4024N3M: The upon a maximum working voltage of: 266.9 Vrms, 919 Vpk-pk; For Model DP4048N3M: The upon a maximum working voltage of: 266.8 Vrms, 849 Vpk-pk; Instructions and equipment marking shall be provided in a language, which is acceptable in the country in which the equipment is to be installed. Additional marking shall be provided per the end product application. The magnetic devices (T1) is provided with an Class B (OBJY2) insulation system. This power supply has been judged on the, basis of the required Creepage and Clearances in the First Edition of the Standard for Medical Electrical Equipment, UL 60601-1, Sub clause 57.10, which covers the end-use product for which the component was designed. This power supply has not been evaluated for patient connected applications. The power supply was evaluated as providing two level of insulation in between Primary and Secondary component. See insulation diagram for details. Maximum Operating Temperature Tma ( C) is 40degC for full load and 60degC for half of the full load. The power supply was tested on a 20A branch, circuit. If used on a branch circuit greater than, this, additional testing may be necessary.
Issue Date: 2009-06-15 Page 8 of 72 Report Reference # E254758-A21-UL-1 CF3.2 CF3.3 CF3.4 CF3.5 CF3.6 CF3.7 The end use application shall insure that the, power supply is used within its ratings. Cleaning, sterilization or disinfection should be, considered in the end use application. The suitability of the appliance inlet used shall be determined in end product application for the requirement of CAN/ CSA polarized type plug. The reliability of the Silkscreen printing should be evaluated at end System. No power supply cord is provided for this power supply, this item must be considered in the end product usage. Models DP4009N3M, DP4012N3M, DP4015N3M, DP4018N3M, DP4024N3M and DP4048N3M additionally provided with two levels of insulation in between of Primary and Secondary circuitry.
Issue Date: 2009-06-15 Page 2 of 2 Report Reference # E254758-A21-UL-1 This is to certify that representative samples of the products covered by this Test Report have been investigated in accordance with the above referenced Standards. The products have been found to comply with the requirements covering the category and the products are judged to be eligible for Follow-Up Service under the indicated Test Procedure. The manufacturer is authorized to use the UL Mark on such products which comply with this Test Report and any other applicable requirements of ('UL') in accordance with the Follow-Up Service Agreement. Only those products which properly bear the UL Mark are considered as being covered by UL's Follow-Up Service under the indicated Test Procedure. The applicant is authorized to reproduce the referenced Test Report provided it is reproduced in its entirety. UL authorizes the applicant to reproduce the latest pages of the referenced Test Report consisting of the first page of the Specific Technical Criteria through to the end of the Conditions of Acceptability. Any information and documentation involving UL Mark services are provided on behalf of (UL) or any authorized licensee of UL. Test Report By: Reviewed By: Calvin Tang Project Engineer UL International Limited Jimmy Deng Project Engineer Underwriters Laboratories Taiwan Co., Ltd. Copyright 2009