Ref. Certif.
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CB TEST CERTIFICATE
Product
Produit
Name and address of the applicant
Nom et adresse du demandeur
Name and address of the manufacturer
Nom et adresse du fabricant
Name and address of the factory
Nom et adresse de l'usine
Note: When more than one factory, please report on page 2
Note: Lorsque it y plus d'une usine, veuillez utiliser la 2'= page
Ratings and principal characteristics
Valeurs nominales et caracteristiques
principales
Trademark (if any)
Marque de fabrique (si elle existe)
Model/Type
Ref.
Ref. De type
Additional information (if necessary, may also be reported
on page 2)
Les informations complementaires (si necessaire, peuvent
etre indiques sur la 2'm' page)
A sample of the product was tested and found
to be in conformity with
Un echantillon de ce produit a ete essaye et a ete
considere conforme a la
As shown in the Test Report Ref. No. which forms part of
this Certificate
Comme indique dans Ie Rapport d'essais numero de
reference qui constitue partie de ce Certificat
This CB Test Certificate is issued by the National Certification Body
Ce Certificat d'essai OC est etabli par l'Organisme Natioinal de Certification
ISSUED2003-05
No.
US- TUVR-4428
Ref. Certif. No.
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W
TUVRheinland1
July 10, 2008
Date:
ISSUED
2003.05
Page 2 of 2
Signature:
US-TUVR-4428
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 1 of 2
Report Reference #
E145177-A9-UL-1
COVER PAGE FOR TEST REPORT
Product Category:
Product Category CCN:
Test Procedure:
Product:
Model/Type Reference:
Rating(s):
Standards:
Applicant Name and
Address:
Power Supplies, Medical and Dental
QQHM2, QQHM8
Component Recognition
Component Power Supply
MW155RAXYFZ, where X represents the output voltage which may be the
number 12, 15, 18 or 24; Y indicates the output connector style which may be any
number from 00-99; F indicates the C14 type AC inlet; and Z represents
non-safety related customer options which may be any number from 00-99.
Input: 100-240 V~, 50-60 Hz, 2.0-1.0 A
Output:
MW155RA12YFZ: 12 V dc/8.33 (100-110 V~); 12 V dc/9.165 A (>110-240 V~)
MW155RA15YFZ: 15 V dc/7.33 A
MW155RA18YFZ: 18 V dc/6.66 A
MW155RA24YFZ: 24 V dc/5.0 A
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)
SL POWER ELECTRONICS CORP
6050 KING ST
VENTURA CA 93003
UNITED STATES
This Report includes the following parts, in addition to this cover page:
1. Specific Technical Criteria
2. Clause Verdicts
Copyright © 2009
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 2 of 2
Report Reference #
E145177-A9-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:
Ahmad Daoudi
Engineering Associate
Underwriters Laboratories Inc.
Marc M. Mouser
Manager
Underwriters Laboratories Inc.
Copyright © 2009
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 1 of 5
Report Reference #
E145177-A9-UL-1
SPECIFIC TECHNICAL CRITERIA
TEST REPORT
UL 60601-1
Medical Electrical Equipment
Part 1: General requirements for safety
Report Reference No ........................: E145177-A9-UL-1
Compiled by .....................................: Ahmad Daoudi
Reviewed by ....................................: Marc M. Mouser
Date of issue ....................................: 2008-05-16
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 .......................: Component Power Supply
Trademark ........................................:
Model and/or type reference ............: MW155RAXYFZ, where X represents the output voltage which may be
the number 12, 15, 18 or 24; Y indicates the output connector style
which may be any number from 00-99; F indicates the C14 type AC
inlet; and Z represents non-safety related customer options which may
be any number from 00-99.
Rating(s) ...........................................: Input: 100-240 V~, 50-60 Hz, 2.0-1.0 A
Output:
MW155RA12YFZ: 12 V dc/8.33 (100-110 V~); 12 V dc/9.165 A
(>110-240 V~)
MW155RA15YFZ: 15 V dc/7.33 A
MW155RA18YFZ: 18 V dc/6.66 A
MW155RA24YFZ: 24 V dc/5.0 A
TRF No.: IEC60601_1C
Underwriters Laboratories Inc.
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 2 of 5
Report Reference #
E145177-A9-UL-1
GENERAL INFORMATION
Test item particulars (see also clause 5):
Classification of installation and use ......................... :
Portable
Supply connection ..................................................... :
Appliance coupler
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
The MW155RAXYFZ is used as a desktop and/or portable power supply. A green LED is provided
to indicate DC output is present.
CC1.0
Model Differences
CC1.1
The MW155RAXYFZ is Class I unit, where X represents the output voltage which may be the
number 12, 15, 18 or 24; Y indicates the output connector style which may be any number from
00-99; F indicates the C14 type AC inlet; and Z represents non-safety related customer options
which may be any number from 00-99. The transformers have different turns and gage but have
similar construction.
TRF No.: IEC60601_1C
Underwriters Laboratories Inc.
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 3 of 5
Report Reference #
E145177-A9-UL-1
CD1.0
Additional Information
CD1.1
The schematics are kept on file at the CB Testing Laboratory mentioned in the first page of this test
report, and can be provided by the applicant upon request by CBTLs/NCBs.
All tests were conducted at the SMT facility.
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
of water is:
CE1.5
The following accessories were investigated for ,
use with the product:
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.
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), UL 60601-1, 1st
Edition, 2006-04-26 (includes National
Differences for USA)
Casualty, Fire , Shock
When installed in an end-product, consideration must be given to the following:
CF2.0
This component has 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, which covers the end use product for
which the component is designed.
CF2.1
The component is provided with a plastic
enclosure and an appliance inlet
TRF No.: IEC60601_1C
--
Underwriters Laboratories Inc.
Issue Date:
2008-05-16
Correction 1
2009-04-10
Page 4 of 5
Report Reference #
CF2.2
The output circuits have not been evaluated for -direct patient connection (Type B, BF or CF).
CF2.3
The Temperature Test was performed in an
-ambient of 25 °C and were calculated for a
raised ambient of 40°C. In some instances, the
temperature test was repeated in an ambient of
40°C to validate the calculation.
CF2.4
The power supply was evaluated as Reinforced -insulation between primary and secondary;
basic insulation between primary to heatsink;
and operational insulation between secondary to
heatsink.
CF2.5
This power supply has been evaluated as Class I -equipment, continuous operation, and has not
been evaluated for use in the presence of a
flammable anesthetic mixture with air, oxygen,
or nitrous oxide.
CF2.6
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.
CF2.7
The product was evaluated for desktop 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.
CF2.8
Leakage current measurements must be
-performed on the combination power supply and
the end-use product.
CF2.9
Installation instructions and end product
markings are the responsibility of the end-use
product manufacturer.
CF3
At 90V~ input, the 12V model output is derated -to 12Vdc, 8.33A to comply with the temperature
limit. Above 90V~ input, the 12V model complies
with the temperature limit with a rated output
12Vdc, 9.165A
CF3.1
Earth leakage current was measured using Figs -10 and 11 of UL60601-1.
TRF No.: IEC60601_1C
--
Underwriters Laboratories Inc.
E145177-A9-UL-1
~
..
Certificate
@
TUVRheinland
Certificate no.
'
I
W206.1.59S4.1......
License Holder:
SL Power Electronics Corp.
7105 Northland Terrace
Minneapolis MN
55428
USA
Manufacturing Plant:
SL Power Electronics
Anping Economic and
Technical Developing
065402 Xianghe
China
Test report no.:
Tested to:
USA-JAK 09571156 062
EN 60601-1:1990+A1+A2+A13
Client Reference:
Addition:
Model Designation:
Zone
County, Hebei
Tim Cassidy
License Fee
Medical Power Supply
Certified Product:
Xianghe
- Units
MW155X1X2X3X3X4X4X5X6X6
(X1,X2 = A-Z;
X5 = F;
Xl, X2, X4, X6 not safety-relevant)
Rated
Voltage:
Rated
Current:
Protection
X4,X6 = 0-9;
1) AC 100-110V, 50-60Hz;
or AC 110-240V, 50-60Hz; (X3X3=12)
2) AC 100-240V, 50-60Hz; (X3X3=15,18,24)
1) 2.0A or 2.0-1.0A;
Class:
2)
I
2. 0 - 1 . OA
contd.
Appendix:
I, 1-5
Inh. = 747695 / Deb. = 747695 / Fert. = 751962
Licensed Test mark:
A
IEN _1-1
Date of Issue
(day/mo/yr)
08/07/2008
Signatures
d£kt
Stephan Schmitt
President
J ll.
('fI!!JffiliJc.
i
.
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... . .,.
[. G gla
QA Certification Officer
A
..
Certificate
@
TUVRheinland
Certificate no.
I
License Holder:
SL Power Electronics Corp.
7105 Northland Terrace
Minneapolis MN
55428
USA
Manufacturing Plant:
SL Power Electronics
Anping Economic and
Technical Developing
065402 Xianghe
China
Test report no.:
Tested to:
USA-JAK 09571156 062
EN 60601-1:1990+A1+A2+A13
Certified Product:
Client Reference:
Xianghe
Zone
County, Hebei
Tim Cassidy
License Fee
Medical Power Supply
- Units
contd.
Output Ratings:
1) DC +12V, 8.33A
DC +12V, 9.165A
2) DC +15V, 7.33A
DC +18V, 6.66A
DC +24V, 5.0A
(X3X3=12)
(X3X3=12)
(X3X3=15)
(X3X3=18)
(X3X3=24)
Inh. = 747695 / Deb. = 747695 / Fert. = 751962
Licensed Test mark:
A
IEN 60601-1
Signatures
d~t
Stephan Schmitt
President
fbtl1
~
G gla
QA Certification Officer
Date of Issue
(day/mo/yr)
08/07/2008