ul test report and procedure

Issue Date:
2011-02-09
Page 1 of 16
Report Reference #
E116994-A60-UL
UL TEST REPORT AND PROCEDURE
Standard:
Certification Type:
CCN:
Product:
Model:
Rating:
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)
Component Recognition
QQHM2, QQHM8 (Power Supplies, Medical and Dental)
Switching Power Supply
MENT1150AWWXXYZ Series;
Where A is an alpha character A-Z, WW is a number 0-48, XX is a 2
digit number 00-99, Y is an alpha character A-Z, and Z is a number
00-99.
Input: 100-240 V~, 50-60 Hz, 3.0 A
Output: 48 V maximum,
11.67 A maximum,
or see below for standard output models.
MENT1150V12XXFZ: 12 V dc/11.67 A;
MENT1150V15XXFZ: 15 V dc/9.33 A;
MENT1150V18XXFZ: 18 V dc/7.78 A;
MENT1150V24XXFZ: 24 V dc/6.25 A;
MENT1150V28XXFZ: 28 V dc/5.36 A;
MENT1150V48XXFZ: 48 V dc/3.13 A.
Applicant Name and Address:
SL POWER ELECTRONICS CORP
BLDG A
6050 KING ST
VENTURA CA 93003
UNITED STATES
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.
Copyright © 2011
Issue Date:
Prepared by:
Reviewed by:
2011-02-09
Page 2 of 16
Bob Hilbrecht
Underwriters Laboratories Inc.
Michael J. Howell
Underwriters Laboratories Inc.
Copyright © 2011
Report Reference #
E116994-A60-UL
Issue Date:
2011-02-09
Page 3 of 16
Report Reference #
E116994-A60-UL
Supporting Documentation
The following documents located at the beginning of this Procedure supplement the requirements of this Test
Report:
A. Authorization - The Authorization page may include additional Factory Identification Code markings.
B. Generic Inspection Instructions i. Part AC details important information which may be applicable to products covered by this Procedure.
Products described in this Test Report must comply with any applicable items listed unless otherwise
stated in the body of this Test Report.
ii. Part AE details any requirements which may be applicable to all products covered by this Procedure.
Products described in this Test Report must comply with any applicable items listed unless otherwise
stated in the body of each Test Report.
iii. Part AF details the requirements for the UL Certification Mark which is not controlled by the technical
standard used to investigate these products. Products are permitted to bear only the Certification
Mark(s) corresponding to the countries for which it is certified, as indicated in each Test Report.
Issue Date:
2011-02-09
Page 4 of 16
Report Reference #
E116994-A60-UL
Product Description
Component - Switching Power Supply
Model Differences
The models differ in output ratings which requires different turns and wire gauge in transformer T200 and
secondary circuitry component values to accommodate the rated output.
Model number nomenclature explains construction as follows:
MENT1150AWWXXYZ; Where A is an Alpha Character that represents generational differences, WW is a
Numeric indicator of output voltage, XX is a 2 digit Numeric indicator of external connectors, Y is an alpha
character that represents Input Options, and Z is a numeric indicator where 00 is the standard configuration
and 01-99 are custom modifications that may or may not be related to Safety.
Where A signifies generational differences which may have impact on safety the specific letter will be
documented in this Report.
Technical Considerations

Classification of installation and use : Portable

Supply connection : Appliance coupler

Accessories and detachable parts included in the evaluation : None

Options included : None

The product was investigated to the following additional standards:: EN 60601-1: 1990 + A1:1993 +
A2:1995; (except EMC limitations, EN 60601-1-2, Biocompatibility, EN 10993-1, Programmable
Electronic Systems, IEC 60601-1-4), UL 60601-1, 1st Edition, 2006-04-26 (includes National
Differences for USA); CAN/CSA-C22.2 No. 601.1-M90 (R2005) (includes National Differences for
Canada)

The product was not investigated to the following standards or clauses:: Clause 36, Electromagnetic
Compatibility (IEC 601-1-2), Clause 48, Biocompatibility (ISO 10993-1), Clause 52.1, Programmable
Electronic Systems (IEC 601-1-4)

The product is Classified only to the following hazards:: Casualty, Fire, Shock

The degree of protection against harmful ingress of water is:: IPX0

The following accessories were investigated for use with the product:: None

The mode of operation is:: Continuous

Software is relied upon for meeting safety requirements related to mechanical, fire and shock:: No

The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen
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2011-02-09
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Report Reference #
E116994-A60-UL
or with nitrous oxide:: No
Engineering Conditions of Acceptability
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:

This component has been judged on the basis of the required spacings in the First Edition of the
Standards for Medical Equipment, Part 1: General Requirements for Safety, UL60601-1 and CSA
22.2 No. 601.1, which covers the end use product for which the component is designed. , , 2. The
component shall be installed in compliance with the enclosure, mounting, spacings, 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. , , 4. The input/output connectors are not
acceptable for field connection, they are only intended for connection to mating connectors of internal
wiring inside the end-use machine. The output circuits have not been evaluated for direct patient
connection (Type B, BF or CF). , , 5. The temperature test was performed in a raised ambient of 40
°C. , , 6. Leakage Current test should be repeated in the end-product application. , , 7. The Power
Transformers (T200) and Inductor L102 comply with Class B (130°C) limits. , , 8. This power supply
has been evaluated as Class I, continuous operation, ordinary equipment and has not been
evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.
, , 9. The Class I model power supply was evaluated as Reinforced insulation between primary and
secondary; basic insulation between primary to ground/heatsink. In addition, the power supply was
evaluated with either the output + or - connected to ground/heatsink. , 10. The component is
provided with a plastic enclosure (V-0) that is suitable for fire and shock hazards. , 11. The output
has been evaluated and tested for operator accessible part. Under normal and single fault
conditions, the outputs do not exceed 25 V ac or 60 V dc. , 12. The product was evaluated as a desk
top and/or portable use only. Additional evaluation may be required as part of end product
investigation to insure compliance of the product as mobile device. , 13. Installation instructions and
end product markings are the responsibility of the end-use product manufacturer. , 14. The following
statement shall be provided for Class I models in the end product. "To ensure that grounding
reliability is achieved, the power supply shall be connected to receptacle marked 'Hospital Only' or
'Hospital Grade'. The marking can be provided on the power supply, the end product, or on the
power supply cord set. , 15. Capability of the equipment to withstanding cleaning, sterilization or
disinfection without deterioration has not been evaluated. Additional evaluation may be required as
part of end product investigation. ,
Additional Information
The schematics for these models are kept on file at the Testing Laboratory mentioned in the first page of this
test report, and can be provided by the manufacturer upon request by an accepting NCB.
Light Emitting Diodes (LED's) employed on the units are for use as visual indicators only, and operate within
Class 1 limits in accordance to IEC 60825 Standard. The LED's operate in the visible range of 400 to 710
nm. Applicant to furnish LED specifications upon request.
The attached label is a draft of artwork for marking plate pending approval by National Certification Bodies.
The artwork provided is representative of all models in the Series.
The attached Licenses for the Critical Components effective for three years from the date of issue noted on
the License. A Recognizing National Certification Body (NCB), may challenge the CB Test Certificate when it
Issue Date:
2011-02-09
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Report Reference #
E116994-A60-UL
is more than three years old.
Current Licenses for critical components to be furnished by applicant upon request.
Testing to applicable collateral standards was not conducted by UL and no supporting evidence of
compliance has been presented. When submitting this Test Report to other Certification Body, the
manufacturer is responsible for providing any additional information that the Body may need in order to issue
its Mark, including testing for compliance with the applicable collateral standards.
Marking Durability - Results of the Marking Durability test were obtained from the following Report covering
previously tested similar models:
- Silkscreen. Reference Report E145117-A4-CB-1, Issued 2007-07-26, Certificate # US/11777B/UL.
- Label system. Reference Report E116994-A51-CB-1, Issued 2009-12-22, Certificate # US/14580/UL.
Additional Standards
The product fulfills the requirements of: EN 60601-1: 1990 + A1:1993 + A2:1995 (except EMC limitations, EN
60601-1-2, Biocompatibility, EN 10993-1, Programmable Electronic Systems, IEC 60601-1-4); UL 60601-1,
1st Edition, 2006-04-26 (includes National Differences for USA); CAN/CSA-C22.2 No. 601.1-M90 (R2005)
(includes National Differences for Canada)
Markings and instructions
Clause Title
Marking or Instruction Details
Company identification
Classified or Recognized company's name, Trade name, Trademark or File
Model
Model number
Alternating current
Supply Connection
Voltage range, ac/dc, phases if more than single phase
Supply Frequency
Rated frequency range in hertz
Power Input
Amps, VA, or Watts
IP Rating
IPX1
Fuses
Ratings (current and voltage) and type. (located adjacent to fuse OR as a diagram
inside enclosure)
Output
Rated output voltage, power, frequency.
Attention, consult
accompanying
documents
Special Instructions to UL Representative
N/A
Issue Date:
2011-02-09
Page 7 of 16
Report Reference #
E116994-A60-UL
Production-Line Testing Requirements
Test Exemptions - The following models are exempt from the indicated test
Model
Grounding Continuity
Dielectric Voltage
Withstand
Patient Circuit Dielectric
Voltage Withstand
MENT1150A family
Test
Test
Exempt
Solid-State Component Test Exemptions - The following solid-state components may be disconnected
from the remainder of the circuitry during either Dielectric Voltage Withstand Test:
N/A
Sample and Test Specifics for Follow-Up Tests at UL
The following tests shall be conducted in accordance with the Generic Inspection Instructions
Model
Samples
Test
Test Details
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