Page 1 of 9 - Artesyn Embedded Technologies · Page 1 of 9 Jiangsu TÜV Product ... and appended to a CB Test Certificate issued by an NCB in accordance ... This Test Report Form

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Jiangsu TÜV Product Service Ltd. -Shenzhen Branch TRF No. IEC60601_1G_PS

12 Test Report issued under the responsibility of:

NCB TÜV SÜD PSB 1 Science Park Drive, 118221 Singapore Singapore

TEST REPORT IEC 60601-1

Part 1: General requirements for basic safety and essential performance

Report Number. .............................. : 211-2312154-201

Modification Test Report Ref. No. : 211-2312154-200

Modification .................................... : See General remarks on page 6

Modification to Clause .................. : N/A

Pages Concerned ......................... : 1, 3, 5, 6, 8 on the report 211-2312154-200

Date of issue .................................. : 2013-07-25

Total number of pages .................. : 9

Applicant’s name ........................... : Astec International Ltd.

Address........................................... : 16th Floor, Lu Plaza, 2 Wing Yip Street, Kwun Tong, Kowloon, HONG KONG

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_PS

Test Report Form(s) Originator .... : UL

Master TRF ..................................... : 2012-12

Copyright © 2012 Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (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 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.

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Report Reference No.: 211-2312154-201


List of Attachments (including a total number of pages in each attachment):

N/A

Summary of testing:

Tests performed (name of test and test clause): Testing location:

The test subject has been assessed for safety with respect to the above test specifications and found to comply with the requirements of IEC 60601-1:2005.

Exceptions: The following clauses / collaterals were not part of the manufacturers order and therefore excluded from this testing:

Clause 11.7 Biocompatibility, referencing ISO 10993

Clause 12.2 Usability, referencing IEC 60601-1-6

Clause 17 EMC, referencing IEC 60601-1-2

Jiangsu TÜV Product Service Ltd. – Shenzhen Branch

6/F, H Hall, Culture Creative Park, No.4001, Fuqiang Road, Futian District, Shenzhen, Guangdong, P.R. China

Summary of compliance with National Differences:

List of countries addressed: National and Group differences as per CB bulletin.

The product fulfils the requirements of SN EN 60601-1:2006, CAN/CSA-C22.2 No. 60601-1:08 and ANSI/AAMI ES60601-1: 2005.

This CB report also covers the EN 60601-1: 2006 for project 682301215405.

Copy of marking plate:

The artwork below may be only a draft. The use of certification marks on a product must be authorized by the respective NCBs that own these marks.

Rating labels for model LCM1500Q-T

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Rating labels for model LCM1500W-T

Rating labels for model LCM1500U-T

Alternate rating label format for model LCM1500X-T series

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Test item particulars (see also Clause 6)

Classification of installation and use ...................... : Built-in

Device type (component/sub-assembly/ equipment/ system ..................................................... :

Component

Intended use (Including type of patient, application location) ............................................... :

Power supply to medical device

Mode of operation ...................................................... : Continuous

Supply Connection .................................................... : Built-in component, considered in end use

Accessories and detachable parts included .......... : N/A

Other options included .............................................. : N/A

Possible test case verdicts:

- test case does not apply to the test object .......... : N/A

- test object was not evaluated for the requirement ................................................................. :

N/E

- test object does meet the requirement ................. : P (Pass)

- 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

Testing

Date of receipt of test item ....................................... : 2013-07-24

Date (s) of performance of tests ............................. : 2013-07-24 to 2013-07-25

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General remarks:

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 Issuing testing laboratory. "(see Enclosure #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report. Throughout this report a comma / point is used as the decimal separator.

This Test Report Form is intended for the investigation of power supplies in accordance with IEC 60601-1:2005, 3

rd edition. The Risk Management was excluded from the investigation; this shall be clearly

identified in this report and on the accompanying CB Test Certificate.

Additional test data and/or information may be provided in the attachments to this report.

According to the EU decision 768/2008/EC and German product safety law (ProdSG), the name and

address of manufacturer (an EU-based importer or authorized representative if the manufacturer is not

based in EU) shall be affixed on the product or, where that is not possible, on its packaging or in a

document accompanying the product before the product is placed on EU market.

Amendment:

The original Test Report Ref. No. 211-2312154-200, dated 2013-07-04 was modified on 2013-07-25 to

include changes/additions as following:

- For model LCM1500W-T: change its adjusted output voltage range from +48V±10% to

+48V-12.5%/+10% limited to the combined conditions: maximum allowed 32.0A output current and 1500W

output power.

This report is not valid without the original Test Report Ref. No. 211-2312154-200 dated on 2013-07-04

with CB Certificate Ref No. SG-MD-00318M2 dated on 2013-07-08.

Manufacturer’s Declaration per sub-clause 4.2.5 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) .............................. : 1) Astec Power Philippines Inc. Main Avenue Corner Rd “J”, Cavite Export Processing Zone, Rosario, Cavite, Philippines

2) Astec Power Philippines Inc 104 Laguna Boulevard, Laguna Technopark, 4026 Sta Rosa Laguna, Philippines

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General product information:

Model Differences:

The constructions of these series models are identical except for the power transformer T801, output rating and dimension or shape of heat sink HTSK1, HTSK3/HTSK4.

Technical Considerations:

1) Scope of Power Supply evaluation defers the following clauses to be determined as part of the end product investigation:

- Clause 7.5 (Safety Signs),

- Clause 7.9 (Accompanying Documents),

- Clause 9 (ME Hazard), except 9.1 and 9.3 are evaluated,

- Clause 10 (Radiation),

- Clause 14 (PEMS),

- Clause 16 (ME Systems)

- Risk Management was excluded from this investigation.

2) Risk Controls/ Engineering Considerations for component power supply:

For use only in or with complete equipment where the acceptability of the combination is determined by the CB Testing Laboratory, when installed in an end-product, consideration must be given to the following:

- For Power Supplies with No RM: End product Risk Management Process to include consideration of requirements specific to the Power Supply.

- For Power Supplies with No RM: End product Risk Management Process to consider the acceptability of risk for the following components that were identified as High-Integrity Component: i.e. Fuse (F1).

- For Power Supplies with No RM: End product Risk Management Process to consider the need for simultaneous fault condition testing.

- For Power Supplies with No RM: End product Risk Management Process to consider the need for different orientations of installation during testing.

- For Power Supplies with No RM with Exposure Condition outside of Humidity Range: Power Supply tested in __30__°C, __95__%RH. End product Risk Management Process to determine risk acceptability criteria.

- For Power Supplies with No RM and Insulating Materials: End product to determine the acceptability of risk in conjunction to insulation to resistance to heat, moisture, and dielectric strength.

- For Power Supplies with No RM: End product to determine the acceptability of risk in conjunction to the movement of components as part of the power supply.

- For Power Supplies with No RM: End product to determine the acceptability of risk in conjunction to the movement of conductors as part of the power supply.

- For Power Supplies with No RM: End product to determine the acceptability of risk in conjunction to the routing of wires away from moving parts and sharp edges as part of the power supply.

- For Power Supplies with No RM and Not tested with Test Corner: Temperature Test was conducted without Test Corner. End product to determine the acceptability of risk in conjunction to temperature

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testing without test corner as part of the power supply.

- For Power Supplies with No RM or Units without Cleaning/Disinfection Methods: End product to determine the acceptability of risk in conjunction to the Cleaning and Disinfection Methods as part of the power supply.

- For Power Supplies with No RM or Units with Liquids: End product to determine the acceptability of risk in conjunction to the Leakage of Liquids as part of the power supply.

- For Power Supplies with No RM or Units with Indicators: End product to determine the acceptability of risk in conjunction to the Arrangement of Indicators as part of the power supply.

- For Power Supplies with No RM or Units with Enclosures: End product to determine the acceptability of risk in conjunction to the results of Mechanical Testing conducted as part of the power supply

- For Power Supplies with No RM: End product to determine the acceptability of risk in conjunction to the selection of components as it pertains to the intended use, essential performance, transport, storage conditions as part of the power supply

- For Power Supplies with Thermal Cut-off and No RM: End product to determine the acceptability of risk in conjunction to the use of Thermal Cut-off and Overcurrent releases as part of the power supply

- For Power Supplies with Pre-set components and No RM: End product to determine the acceptability of risk in conjunction to the use of Pre-set controls as part of the power supply.

Other remarks:

1) When installing these equipments, all requirements of the mentioned standard must be fulfilled.

2) Refer to the safety instructions for details of loading conditions and operating ambient conditions.

3) This power supply contains output exceeding 240VA, when installing into end system, care must be taken that the output and associated wire(s) may not be touched.

4) Clearance was evaluated for operating altitude up to 3048m above sea level.

5) These power supplies are intended to be built into the end use product.

6) Compliance with the requirements for EMC shall be evaluated for the end use product.

7) These products have been investigated only as a component part for use in equipment where the suitability of the combination is subject to end product investigation.

8) These power supplies are designed to be protectively earthed. Earthing connection and continuity test shall be checked in end product.

9) These power supplies must be installed in accordance with the instruction manual.

10) The leakage current test shall be checked in end product.

11) For model LCM1500Q-T: Additional evaluation has been considered for the +24V±10% output voltage adjustability limited to the combined conditions: maximum allowed 63.0A output current and 1500W output power.

12) For model LCM1500W-T: Additional evaluation has been considered for the +48V-12.5%/+10% output voltage adjustability limited to the combined conditions: maximum allowed 32.0A output current and 1500W output power.

13) For model LCM1500U-T: Additional evaluation has been considered for the +36V±10% output voltage adjustability limited to the combined conditions: maximum allowed 42.0A output current and 1500W output power.

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14) For operating temperature up to 50C, the +24V/+48V/36V output of the equipment can be loaded full

loading, and for operating temperature over 50C and up to 70C, the output loading should be decreased by 2.5% per 1 degree rise.

Loading conditions during following tests:

For model LCM1500Q-T:

- Loading 1 : +23.81V, 63.0A;+5Vsb, 2.0A

- Loading 2 : +26.4V, 56.82A; +5Vsb, 2.0A

- Loading 3 : +24.0V, 62.5A; +5Vsb, 2.0A

- Loading 4 : +23.81V, 31.5A; +5Vsb, 2.0A (50%-load of Loading 1 at operating temperature 70°C)

- Loading 5 : +23.81V, 47.25A; +5Vsb, 2.0A (75%-load of Loading 1 at operating temperature 60°C)

For model LCM1500W-T:

Loading 1: +46.88V, 32.0A; +5Vsb, 2.0A

Loading 2: +52.80V, 28.41A; +5Vsb, 2.0A

Loading 3: +48.0V, 31.25A; +5Vsb, 2.0A

Loading 4: +46.88V, 24.0A; +5Vsb, 2.0A (75% load of Loading 1 at operating temperature 60°C)


For model LCM1500U-T:

Loading 1: +35.72V,42.0A; +5Vsb, 2.0A

Loading 2: +39.60V,37.88A; +5Vsb, 2.0A

Loading 3: +36.0V,41.67A; +5Vsb, 2.0A



END OF TEST REPORT