File E116994 Project 06CA53754

November 28, 2006

REPORT ON COMPONENT - POWER SUPPLIES MEDICAL AND DENTAL POWER SUPPLY

SL Power Electronics Corp. Ventura, California

Copyright 2006 Underwriters Laboratories Inc. Underwriters Laboratories Inc. authorizes the above named company to reproduce this Report provided it is reproduced in its entirety. Underwriters Laboratories Inc. authorizes the above named company to reproduce that portion of this Report consisting of this Cover Page through Page 4.

File E116994

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DESCRIPTION

PRODUCT COVERED: USR, CNR - Switching Power Supply, Models GPM130A, GPM130B, GPM130C, GPM130D, GPM130E, MSP1311, MSP1311A-102, and MSP1311A-102G. GPM130 models may be provided with the following suffixes: -T, -T1, -T2 –C, -XXX and/or G. Suffix –T indicates terminal block used on input and output connectors; -T1 indicates terminal block used on input; -T2 indicates terminal block used on output; -C indicates cover is provided; -XXX indicates value added configurations that have no impact on safety which may be any number from 001 thru 999; and G indicates compliance to RoHS. (RoHS compliance has not been evaluated by UL.)

ELECTRICAL RATING: Input:

Models GPM 130 Series: 100-240 V ac, 50/60 Hz, 3.5 A Models MSP1311, MSP1311A-102, and MSP1311A-102G: 100-240 V ac, 50/60 Hz, 3.0 A

Model

V1

GPM130A +5 GPM130B +5 GPM130C +5 GPM130D +5 GPM130E +5 MSP1311 +24 MSP1311A-102 +24 MSP1311A-102G +24

A1

V2

A2

20 20 20 20 20 1.0 1.0 1.0

+12 +12 +12 +24 +24 +12 +12 +12

5.0 5.0 5.0 3.5 3.5 1.0 1.0 1.0

V3 -12 -5 -15 -12 -15 +15 +15 +15

A3 1.2 1.2 1.2 1.2 1.2 1.0 1.0 1.0

V4

A4

+12 1.2 -12 1.2 +15 1.2 +12 1.2 +15 1.2 +5 8.0 +5 8.0 +5 8.0

V5

A5

-15 1.0 -15 1.0 -15 1.0

GPM130 Series - Maximum total continuous output power is 130 W with airflow; 110 W convection cooling. MSP1311 - Maximum total continuous output power is 105 W; MSP1311A-102 & MSP1311A-102G – Maximum total continuous output power is 55 W. The units have been evaluated for a maximum ambient of 50 C.

File E116994

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ENGINEERING CONSIDERATIONS (NOT FOR UL REPRESENTATIVE'S USE): For use in products where the acceptability of the combination is determined by Underwriters Laboratories Inc. USR indicates that the product was evaluated to the First Edition of the Standard For Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1. CNR indicates that the product was evaluated to the Standard For Medical Electrical Equipment, Part 1: General Requirements for Safety, CSA C22.2, No. 601.1-M90. Engineering References – Following Illustrations are provided for engineering references: Ill. 1 – Insulation Diagram Ill. 2 – Installation Instructions

File E116994

Vol. 1

Sec. 81 and Report

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Issued:

2006-11-28

Conditions of Acceptability - When installed in the end-use equipment, the following are among the considerations to be made: 1.

The power supplies have been judged on the basis of the required spacings in the First Edition of the Standards for Medical Electrical Equipment, Part 1: General Requirements for Safety, UL 60601-1 and CSA C22.2 No. 601.1-M90, which covers the end use product for which the component is designed.

2.

The component shall be installed in compliance with the enclosure, mounting, spacing, casualty markings and segregation requirements of the end-use application.

3.

Consideration should be given to measuring the temperature on power electronic components and transformer windings when the power supply is installed in the end-use equipment. All transformers comply with Class F (155°C) limits.

4.

The input and output connectors are not acceptable for field connections, they are only intended for connection to mating connectors of internal wiring inside the end-use machine. The acceptability of these in the mating connectors relative to secureness, insulating materials, and temperature shall be considered.

5.

The end-use product shall ensure that a fuse warning marking is provided adjacent to the primary fuse (F1). The marking shall include the following wording: "WARNING - For continued protection against risk of fire, replace only with the same type and ratings of fuse" and the fuse ratings. The minimum letter height should be 7/64 in.

6.

The power supply should be properly bonded to ground in the enduse product.

7.

The power supply has been evaluated for patient care equipment, but not patient connected.

8.

The output circuits have not been evaluated for direct patient connection (Type B, BF or CF).

9.

Leakage current testing should be repeated in the end product application.

10.

The power supplies were evaluated as Reinforced insulation between primary and secondary; basic insulation between primary to ground; and operational insulation only between secondary to ground.

11.

The power supplies have been evaluated as Class I, continuous operation, ordinary equipment and have not been evaluated for use in the presence of a flammable anaesthetic mixture with air, oxygen, or nitrous oxide.

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Sec. 81 and Report

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Issued:

2006-11-28

12.

Fusing when using the GPM130 power supplies in the end product shall be considered since only one fuse rated 3 A, 250 V is provided in the hot side of the input supply circuit.

13.

The power supplies do not exceed 25 V ac or 60 V dc under normal and single fault conditions.

14.

For Models GPM130 Series, Temperature Tests were conducted with a CFM fan located 4 in. from the primary component side of the unit. Consideration should be given to repeating the Temperature Tests if an alternate ventilation system is employed.

15.

The end use product shall ensure that a 43 CFM fan is provided if the power supply is provided with a cover.

Certificate of Compliance Certificate:

1893151 (LR 46516)

Master Contract:

150684

Project:

1893151

Date Issued:

2007/04/19

Issued to:

SL Power Electronics Corp. 7105 Northland Terrace Minneapolis, MN 55428-1534 USA Attention: Mr. Dan Mitchell

The products listed below are eligible to bear the CSA Mark shown with adjacent indicators 'C' and 'US'

Issued by:

Kourosh Saysan, Eng'g Tech.

Authorized by: Shane Stevenson, Product Group Manager

PRODUCTS CLASS 5311 07 CLASS 5311 87 CLASS 5311 20 CLASS 5311 96

- POWER SUPPLIES - Component Type - (CSA 60950-1-03) - POWER SUPPLIES - Component Type - Certified to US Stds. - (CSA 60950-1-03/UL 60950-1, First Edition, NRTL Program) - POWER SUPPLIES - Component Type - For Use in Medical Equipment - POWER SUPPLIES - Component Acceptance - Certified to US Standards

CLASS 5311 07 / 87 - POWER SUPPLIES - Component Type                       

                         ! The 'C' and 'US' indicators adjacent to the CSA Mark signify that the product has been evaluated to the applicable CSA and ANSI/UL Standards, for use in Canada and the U.S., respectively. This 'US' indicator includes products eligible to bear the 'NRTL' indicator. NRTL, i.e. National Recognized Testing Laboratory, is a designation granted by the U.S. Occupational Safety and Health Administration (OSHA) to laboratories which have been recognized to perform certification to U.S. Standards.

DQD 507 Rev. 2004-06-30

Certificate:

1893151 (LR 46516)

Master Contract:

150684

Project:

1893151

Date Issued:

2007/04/19

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DQD 507 Rev. 2004-06-30

Supplement to Certificate of Compliance Certificate:

Master Contract:

1893151

150684

The products listed, including the latest revision described below, are eligible to be marked in accordance with the referenced Certificate.

Product Certification History Project

Date

Description

1893151

2007/04/19

Update and Reissue Report LR 46516-122C to Include Minor Report Corrections, add Suffix "G" Denoting RoHS Compliance and Update Name/Address on C of C

Descriptive Report and Test Results MASTER CONTRACT: 150684 (LR 46516C) REPORT: 1893151 PROJECT: 1893151 Edition 1:

April 19, 2007; Project 1893151 – Vancouver Issued by Kourosh Saysan, Eng’g Tech; Reviewed by Shane Stevenson, AScT. Reviewed by Orest Ewanchyna, P. Eng. Contents:

Certificate of Compliance - Pages 1 to 3 Supplement to Certificate of Compliance – Page 1 Description and Tests – Pages 1 to 3 Attachment 1: Category Report No 109, Rev. L, for Subject Models, consisting of: Pages - 1 to 10 Figure - 1 Illustrations – 1 to 19

PRODUCTS CLASS 5311 07 / 87 - POWER SUPPLIES - Component Type Component type power supplies intended for use with Information Technology Equipment Including Electrical Business Equipment, where the suitability of the combination is to be determined by CSA International. Models GPC130A, GPC130B, GPC130C, GPC130D, GPC130E, SP1290, SP1426, SP1495. CLASS 5311 20 / 96 - POWER SUPPLIES - Component Type - For Use in Medical Equipment Component power supplies for use with Medical Equipment, where the suitability of the combination is to be determined by CSA International. Models GPM130A, GPM130B, GPM130C, GPM130D, GPM130E, MSP1358, MSP1380, MSP1508, MSP1575. Notes: 1. 2.

3.

Maximum ambient temperature for the maximum rated output power is 50°C with 26 CFM airflow (43 CFM with cover). The following suffixes may be used: - C = Cover; Must use minimum 43 CFM for full rated output power. - T = Terminal block for input and output. - T1 = Terminal block for input only. - T2 = Terminal block for output only. The following suffixes may be used: - XXX indicates value added configurations that have no impact on safety which may be any number from 001 through 999; and G indicates compliance to RoHS.

THE STANDARD CSA 60950-1-03/UL 60950-1, 1st EDITION DESIGN MANUAL (ISSUED WITH REPORT 1125259, PROJECT 1722945) IS AN INTEGRAL PART OF THIS REPORT. This report shall not be reproduced, except in full, without the approval of CSA International.

1893151_rep\1\sg DQD 507.10 Rev. 2005-08-31

MASTER CONTRACT: 150684 REPORT: 1893151 PROJECT: 1893151

Page No: 2 Date Issued: April 19, 2007

MARKINGS As described in the attached Category Report No 109 on the subject models. A CSA Mark, adjacent to the submittor's name and/or file number "LR 46516" or submittor's Master Contract "150684". Model designation, complete electrical rating in volts, number of phases and wires, hertz and amperes, and a date code or serial number traceable to the month and year of manufacture and manufacturing facility. ALTERATIONS Markings, as described above, appear on each unit. FACTORY TESTS As described in the attached Category Report No 109 on the subject models. DESCRIPTION The subject model was certified under Category Report No 109 Category file LR 46516C. Please refer to the attached report for full description of the subject models.

1893151_rep\2\sg DQD 507.10 Rev. 2005-08-31

MASTER CONTRACT: 150684 REPORT: 1893151 PROJECT: 1893151

Page No: 3 Date Issued: April 19, 2007

TESTS The tests described in the attached Category Report were performed by the category facility. Edition: 1 (Project 1893151) Re-issued Report LR 46516-122C to include minor report corrections, add suffix "G" denoting RoHS compliance and update name/address on Certificate of Compliance.

1893151_rep\3\sg DQD 507.10 Rev. 2005-08-31