Cover Page For Test Report

Transcript

Issue Date: 2010-06-09 Page 1 of 2 Report Reference # E254758-A26-UL-1 COVER PAGE FOR TEST REPORT Product Category: Product Category CCN: Test Procedure: Product: Model/Type Reference: Rating(s): Standards: Power Supplies, Medical and Dental QQHM2, QQHM8 Component Recognition Switching Power Supply uMP4X-XXX-XXX-XXX-XXX-XX, where "X" may be "C" or "T" or "B", which indicates the input type; where "XXX" may be "S2A" to "S2Y" or "DA+Null" to "DY+Null", which indicates different output loading condition; where "XX" may be "Null", or "00" to "99", which indicates application state. Rating 1: AC Input:100-240V, 50/60Hz, 8A max. or DC Input: 120Vmin.-300Vmax., 8A max. DC Output Power: 400W max. See ID7-13, Representative loading condition for details. Rating 2: AC Input: 200-240V, 50/60Hz, 8A max. or DC Input: 254Vmin.-300Vmax., 8A max. DC Output: 600W max. See ID7-13, Representative loading condition for details. 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. National Differences 7. Enclosures Copyright © 2010 Issue Date: 2010-06-09 Page 2 of 2 Report Reference # E254758-A26-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 Underwriters Laboratories Inc. ('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 Underwriters Laboratories Inc. (UL) or any authorized licensee of UL. Test Report By: Reviewed By: Steve Chiu Associate Project Engineer UL International Limited Mahadevan J. Project Engineer UL India Private Limited Copyright © 2010 Issue Date: 2010-06-09 Page 4 of 56 Report Reference # E254758-A26-UL-1 SPECIFIC TECHNICAL CRITERIA TEST REPORT UL 60601-1 Medical Electrical Equipment Part 1: General requirements for safety Report Reference No ........................: E254758-A26-UL-1 Compiled by .....................................: Steve Chiu Reviewed by ....................................: Mahadevan J. Date of issue ....................................: 2010-06-09 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 .......................: Switching Power Supply Trademark ........................................: Emerson Network Power Model and/or type reference ............: uMP4X-XXX-XXX-XXX-XXX-XX, where "X" may be "C" or "T" or "B", which indicates the input type; where "XXX" may be "S2A" to "S2Y" or "DA+Null" to "DY+Null", which indicates different output loading condition; where "XX" may be "Null", or "00" to "99", which indicates application state. Rating(s) ...........................................: Rating 1: AC Input:100-240V, 50/60Hz, 8A max. or DC Input: 120Vmin.-300Vmax., 8A max. DC Output Power: 400W max. See ID7-13, Representative loading condition for details. Rating 2: AC Input: 200-240V, 50/60Hz, 8A max. or DC Input: 254Vmin.-300Vmax., 8A max. DC Output: 600W max. See ID7-13, Representative loading condition for details. TRF No.: IEC60601_1C UL India Private Limited Issue Date: 2010-06-09 Page 5 of 56 Report Reference # E254758-A26-UL-1 GENERAL INFORMATION Test item particulars (see also clause 5): Classification of installation and use ......................... : Recognized Power Supply Supply connection ..................................................... : Appliance coupler or inlet terminal Accessories and detachable parts included in the evaluation .................................................................. : None Options included ....................................................... : None Possible test case verdicts: - 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 ............................................ : RI DI - reinforced insulation ................ : 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 Report Summary CA1.1 N/A CB1.0 Product Description CB1.1 This unit is a switching mode power supply, employs an appliance inlet/input terminal for plugging in power supply cord (Not provided) or input cable (Not Provided). Isolation transformers are used and all electronic components are mounted on PWB that rated V-0 and housed in a metal enclosure. Four Recognized AC-DC modules are employed in secondary side. CC1.0 Model Differences CC1.1 Model uMP4X-XXX-XXX-XXX-XXX-XX is identical to each other except the four employed AC-DC modules. CD1.0 Additional Information TRF No.: IEC60601_1C UL India Private Limited Issue Date: 2010-06-09 Page 6 of 56 Report Reference # E254758-A26-UL-1 CD1.1 N/A CE1.0 Technical Considerations CE1.1 The product was investigated to the following additional standards: CE1.2 The product was not investigated to the following Clause 36, Electromagnetic Compatibility (IEC standards or clauses: 601-1-2), Clause 48, Biocompatibility (ISO 10993-1), Clause 52.1, Programmable Electronic Systems (IEC 601-1-4) CE1.3 The product is Classified only to the following hazards: CE1.4 The degree of protection against harmful ingress Ordinary (IPX0) of water is: CE1.6 The mode of operation is: Continuous CE1.7 Software is relied upon for meeting safety requirements related to mechanical, fire and shock: No CE1.8 The product is suitable for use in the presence of No a flammable anesthetics mixture with air or oxygen or with nitrous oxide: CF1.0 Engineering Conditions of Acceptability CF1.1 For use only in or with complete equipment where the acceptability of the combination is determined by Underwriters Laboratories Inc. 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) Casualty, Fire, Shock When installed in an end-product, consideration must be given to the following: CF2.0 For use only in or with complete equipment where the acceptability of the combination is determined by Underwriters Laboratories Inc. CF2.1 The equipment has not been evaluated for use in -or likely to be used in the patient vicinity. CF2.2 The end-product Electric Strength Test is to be based upon a maximum measures working voltage of 398 Vrms (This value is bigger than Vpk-pk/2square2), 999 Vpk-pk (Base on Case Model 73-954-0001, report E254758-A23). -- CF2.3 Instructions and equipment marking shall be provided in a language, which is acceptable in the country in which the equipment is to be installed. -- CF2.4 This power supply has been judged on the, basis -of the required Creepage and Clearances in the First Edition of the Standard for Medical TRF No.: IEC60601_1C -- UL India Private Limited Issue Date: 2010-06-09 Page 7 of 56 Report Reference # Electrical Equipment, UL 60601-1, Sub clause 57.10, which covers the end-use product for which the component was designed. CF2.5 This power supply has not been evaluated for patient connected applications. -- CF2.6 The power supply was evaluated as providing two level of insulation in between Primary and Secondary component. See insulation diagram for details. -- CF2.7 Maximum Operating Temperature Tma (°C) must not exceed 50degC for full load and 70degC for half of the full load. -- CF2.8 The power supply was tested on a 20A branch, -circuit. If used on a branch circuit greater than, this, additional testing may be necessary. CF2.9 The end use application shall ensure that the -power supply is used within its designed ratings. CF3 Cleaning, sterilization or disinfection should be, -considered in the end use application. CF3.1 The suitability of the appliance inlet used shall be -determined in the end product application for the requirement of CAN/ CSA polarized type plug if applicable. CF3.2 The reliability of the Silkscreen printing should be evaluated at end System. CF3.3 No power supply cord is provided for this power -supply, this item must be considered in the end product usage. CF3.4 The Earth wire must be connected to any one of -the unit's customer mounting holes by a secure screw and anti-loosening washer that is marked with the Earth Symbol. CF3.5 The disconnection from the line must be in the -end system when DC input application. A suitable DC rated fuse should be provided at the end product side before the supply of this device. TRF No.: IEC60601_1C -- UL India Private Limited E254758-A26-UL-1