93
Issue Date: 2012-10-26 Page 1 of 17 Report Reference # E349607-A34-UL 2016-02-01 Copyright © 2016 UL TEST REPORT AND PROCEDURE Standard: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10)(Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) Certification Type: Component Recognition CCN: QQHM2, QQHM8 (Power Supplies, Medical and Dental) Product: Switch mode power supply Model: EFE300M Series (see model differences for details of models and nomenclature) Rating: 100-240Vac nom, 45-63Hz, 4.9A rms max. (see model differences for details of models and ratings) Applicant Name and Address: TDK-LAMBDA UK LIMITED, KINGSLEY AVENUE, ILFRACOMBE, DEVON, EX34 8ES, UNITED KINGDOM This is to certify that representative samples of the products covered by this Test Report have been investigated in accordan ce w ith the above referenced Standards. The products have been found to comply w ith 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 w hich comply w ith this Test Report and any other applicable requirements of UL LLC ('UL') in acc ordance w ith the Follow - Up Service Agreement. Only those products w hich 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 UL LLC (UL) or any authorized licensee of UL. Prepared by: Manisha De Mel/Hima Chetty Reviewed by: Jakub Sobolewski

UL TEST REPORT AND PROCEDURE · 2018. 7. 26. · Issue Date: 2012 -10 -26 Page 5 of 17 Report Reference # E349607 -A34 -UL 2016 -02 -01 § Device type (component/sub-assembly/ equipment

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Page 1: UL TEST REPORT AND PROCEDURE · 2018. 7. 26. · Issue Date: 2012 -10 -26 Page 5 of 17 Report Reference # E349607 -A34 -UL 2016 -02 -01 § Device type (component/sub-assembly/ equipment

Issue Date: 2012-10-26 Page 1 of 17 Report Reference # E349607-A34-UL

2016-02-01

Copyright © 2016

UL TEST REPORT AND PROCEDURE

Standard: ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10)(Medical Electrical

Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment -

Part 1: General Requirements for Basic Safety and Essential Performance)

Certification Type: Component Recognition

CCN: QQHM2, QQHM8 (Power Supplies, Medical and Dental)

Product: Switch mode power supply

Model: EFE300M Series (see model differences for details of models and nomenclature)

Rating: 100-240Vac nom, 45-63Hz, 4.9A rms max. (see model differences for details of models and ratings)

Applicant Name and Address: TDK-LAMBDA UK LIMITED, KINGSLEY AVENUE, ILFRACOMBE,

DEVON, EX34 8ES, UNITED KINGDOM

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 w ith 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 UL LLC ('UL') in acc ordance with the Follow -Up Service Agreement. Only those products w hich 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 f irst page of the Specif ic

Technical Criteria through to the end of the Conditions of Acceptability. Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL.

Prepared by: Manisha De Mel/Hima Chetty Reviewed by: Jakub Sobolewski

Page 2: UL TEST REPORT AND PROCEDURE · 2018. 7. 26. · Issue Date: 2012 -10 -26 Page 5 of 17 Report Reference # E349607 -A34 -UL 2016 -02 -01 § Device type (component/sub-assembly/ equipment

Issue Date: 2012-10-26 Page 2 of 17 Report Reference # E349607-A34-UL

2016-02-01

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.

Page 3: UL TEST REPORT AND PROCEDURE · 2018. 7. 26. · Issue Date: 2012 -10 -26 Page 5 of 17 Report Reference # E349607 -A34 -UL 2016 -02 -01 § Device type (component/sub-assembly/ equipment

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Product Description

The EFE300M Series are switched mode power supplies for building into host equipment.

Model Differences

Nominal Input Voltage Range 100 - 240V AC Maximum Input Voltage Range 90** - 264V AC Input Frequency 45-63Hz

Maximum Input Current 4.9A rms ** Channel 1 output is linearly derated from 90Vac to 85Vac, 4W per volt to 280W.

All ratings apply for ambient temperatures up to 50°C. From 50 to 70°C the output power is derated at 2.5% per deg C.

EFE300M or EFE-300M models as described below: (may be prefixed by NS - # / where # may be any number of characters indicating non safety related model

differences) Products may additionally be marked with U5x or Y5x where x can be any number of characters indicating non-safety related model differences.

Unit Configuration Code: EFE300Mxy-a-b-cdef-ghijk where:

x= Nothing or J for Japanese models (may have non-safety differences). Y= Blank for Y2 capacitors from output to earth, P for Y1 capacitors from output to earth.

a= Channel 1 output Voltage: see Ch1 in the outputs table below, adjustment range column. b= Standby voltage: see standby voltage table below or 0 for omitted c= HN for Open frame, no fan, with 12V / 1A fan supply. HU for U chassis, no fan, with 12V / 1A fan

supply. HC for Cover + chassis, no fan, with 12V / 1A fan supply. EC for Cover + chassis, end fan (temp controlled). NN for Open frame, no fan, no fan supply. NU for U chassis, no fan, no fan supply. NC for Cover + chassis, no fan, no fan supply. CN for Open frame, no fan, with 12V / 0.25A fan supply. CU for U chassis,

no fan, with 12V / 0.25A fan supply. CC for Cover + chassis, no fan, with 12V / 0.25A fan supply. d= M for molex input connector or equivalent, J for JST connector or equivalent. e= D for dual fused input.

f= S for standard Leakage, L for low Leakage, R for reduced Leakage, T for tiny Leakage. * g= Y for Oring FET included or N for nothing. h= E for enable, T for inhibit, N for no inhibit, no enable.

i= Nothing for horizontal output connector, -V for vertical output connector, -S for screw terminal j= Nothing for standard channel 1 output voltage, -xD or -xPD where D is for units with programmed negative load regulation, PD is for units with programmed positive load regulation, x is the voltage of the

regulation in 100mVolts and is within the Output Adjustment range (example, 7D = 0.7V of negative load regulation, 24PD = 2.4V of positive load regulation). k= Nothing or -x where x is three numbers from 0 to 9 which denotes various output voltage/current

settings within the specified ranges of each output for a particular unit or blank for standard output settings. (may define non-safety related parameters/feature, e.g. reduced primary current limit, reduced OVP)

* L < 300uA leakage, R < 150uA leakage and T < 75uA leakage. Output parameters:

O/P Channel Vout nom (V). Range (V) Max O/P (A) Max O/P (W) CH1 12 11.4 - 13.2* 25 300 (400**)

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24 22.8 - 26.4* 12.5 300 (400**) 28 27 - 32* 10.72 300 (400**)

40 36 - 42* 7.5 300 (350***) 48 47 - 50* 6.25 300 (350***) 50 50.1 - 54* 6.0 300 (350***)

Standby 5 Fixed 2 10 12 Fixed 1 12 13.5 Fixed 1 13.5

Fan output 12 Fixed 0.25 3 12 Fixed 1 12

* Can be adjusted from nominal at the factory only. ** Peak power of 400W for 10 seconds maximum, maximum rms power of 300W: *** Peak power of 350W for 10 seconds maximum, in any 1 minute cycle, maximum rms power of

300W:

where T1 = peakpower time on and T2 = reduced power time on

Maximum continuous power output 300W (excluding fan output) Output Limitations

All standard outputs are SELV up to and including 48V nominal. Voltages above 48V nominal are non SELV and must not be accessible to an end operator..

All outputs have basic spacings to earth, and due consideration must be given to this in the end product design, except for Y50029# which has functional spacings to earth.

Non Standard models. Model: Y5J008# (where # can be any letter) or EFE300MJ-12.1-5-008 or EFE300MJ-12.1-5-008-SGP

Maximum outputs: 12.1V, 21.49A, plus 5V, 2A standby. Maximum ambient: As standard model. Orientations: As standard model.

Comments: Fan speed is controlled at 6600rpm up to and between 45 to 50 degrees C ambient after which the fan resumes its normal nominal voltage rating. Can be fitted with or without fan guard.

Model: Y5J006# (where # can be any letter) or EFE300MJ-12-5-006. Maximum outputs: 11.4V to 13.2V*, 25A, (300W max) plus 5V, 2A standby. Maximum ambient: As standard model.

Orientations: As standard model. Comments: Longer version than standard model to accommodate additional reservoir capacitor for a greater hold up time.

Model Y50029# (where # can be any letter), EFE300M-13-5-HNMDL-NT-S/NS-TLA Maximum outputs: As standard model

Maximum ambient: As standard model. Orientations: As standard model.

Technical Considerations

§ Classification of installation and use : For building in

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§ Device type (component/sub-assembly/ equipment/ system) : Component switch mode power supply

§ Intended use (Including type of patient, application location) : To provide DC power for electronic

circuits within medical equipment

§ Mode of operation : Continuous

§ Supply connection : Connection to mains via host equipment

§ Accessories and detachable parts included : None

§ Other options include : None

§ The product was investigated to the following additional standards:: EN 60601-1: 2006 + CORR:

2010 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance), CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for

Canada), ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes Deviations for United States)

§ The product was not investigated to the following standards or clauses:: Electromagnetic Compatibility (IEC 60601-1-2), Clause 14, Programmable Electronic Systems, Biocompatibility (ISO 10993-1)

§ The degree of protection against harmful ingress of water is:: Ordinary

§ The following accessories were investigated for use with the product:: None

§ The mode of operation is:: Continuous

§ The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide:: No

§ The power supply is Class I

§ The product is Classified only to the following hazards: Casualty, Fire, Shock

§ Software is relied upon for meeting safety requirements related to mechanical, fire and shock: No

§ The product was submitted and tested for use at the maximum ambient temperature (Tma) permitted

by the manufacturer¿s specification of: 50°C (full load); 70°C (output power decreasing linearly by 2.5%/°C above 50°C).

§ The product was assessed for operation at an altitude of 3000m

§ Classification of installation and use: Building-in

§ The Printed Wiring Board Trace was evaluated for protective earthing/bonding.

§ All outputs were evaluated for less than 60Vdc, 42.4Vpk. The applicant has declared the outputs as

SELV for voltages up to and including 48V nominal for standard models. Testing has therefore been conducted to ensure compliance with the limits specified in clause 8.4.2(c).

§ Risk Management has not been applied to these products.

Engineering Conditions of Acceptability

For use only in or with complete equipment where the acceptability of the combination is determined by UL LLC. When installed in an end-product, consideration must be given to the following:

§ Insulation separation between: Primary and Secondary is two MOPP's: 408Vrms, 880Vpeak ,

Insulation separation between: Primary and Earth is one MOOP: 392Vrms, 668Vpeak , Insulation separation between: Secondary and Earth is one MOPP for EFE300MP models and one MOOP for all other models: 240Vrms, 340Vpeak ,

§ Branch circuit protection required: 16A (20A For North America and Canada)

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§ The following outputs are considered SELV: All standard model outputs up to and including 48V nominal. Voltages , above 48V nominal are non-SELV and therefore all outputs become non SELV

and must not be , accessible to an operator. ,

§ Some PWB mounted components are rated at the minimum coating rating of 125°C

§ Consideration should be given to repeating the Earth Leakage Tests in the end use equipment.

Additional Information

This report was generated on the basis of report E349607-D2-CB-1 dated 2012-01-11 and the following had been added in addition: 1/ Include alternative input fuses (abnormal testing was applied).

2/ Include new screw terminal output variant within the nomenclature of the EFE300M series. (No testing applied based on examination of the changes) 3/ Include a "no standby option" within the nomenclature (thermal test applied to be sure the new airflow

through the product did not increase temperatures of critical components). 4/ Inlude an assessment of the primary to secondary barrier for 2 MOPP's.

Additional Standards

The product fulfills the requirements of: CAN/CSA-C22.2 No. 60601-1 (2008) (Medical Electrical Equipment -

Part 1: General Requirements for Basic Safety and Essential Performance) (includes National Differences for Canada) ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) (includes Deviations for United States)

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

Supply Connection Voltage range, ac/dc, phases if more than single phase

Alternating current

Supply Frequency Rated frequency range in hertz

Output Rated output voltage, power, frequency.

Fuses Ratings (current and voltage) and type. (located adjacent to fuse OR as a diagram inside enclosure)

Special Instructions to UL Representative

N/A

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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

All Required Required 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:

Component

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

Plastic Enclosure or Part Test Sample(s) Test Specifics

N/A - - -

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TABLE: List of Critical Components

Object/part or

Description

Manufacturer/

trademark

type/model technical data CCN Marks of

Conformity

PWB's Various Various 94V-1 (Minimum) 130°C ZPMV2 UL

J1 input connector Molex 41791 series 250V, 7A ECBT2 (E29179) UL

J1 input connector (Alternative1)

Tyco MTA series 250V, 7A ECBT2 (E28476) UL

J1 input connector (Alternative2)

JST VH 250V, 7A ECBT2 (E60389) UL

XR55 and XR54 Discharge resistors

Various Various 180kohm, 1W - -

Fuse F1 (two fuses) Littelfuse 216008 F8A, 250V 5x20mm

JDYX2 (E10480) UL

Fuse F1 (two fuses) alternative

Schurter SP series F8AH, 250V 5x20mm

JDYX2 (E41599) UL

F1 Fuse holder Various TDKL Part No: 67110

Manufactured by EI Dupont Rynite FR530 or FR530L, 0.8mm thick rated 94V-0, RTI 155°C

QMFZ2 -

C7 and C8 X Capacitors (Optional)

Evox Rifa AB (Kemet)

PHE840M Series 470nF maximum, 250V, X2 105°C FOWX2 (E73869) UL

C7 and C8 X Capacitors (Optional) (Alternative1)

Arcotronics SPA R.46 Series 470nF maximum, 250V, X2 110°C FOWX2 (E97797) UL

C7 and C8 X Capacitors (Optional) (Alternative2)

Vishay (BC Components)

MKP 338-2 Series 470nF maximum, 250V, X2 105°C FOWX2 (E112471)

UL

C7 and C8 X Capacitors (Optional) (Alternative3)

Carli Electronics Co Ltd

MPX Series 470nF maximum, 250V, X2 100°C FOWX2, (E120045)

UL

C7 and C8 X Capacitors (Optional) (Alternative4)

Xiamen Faratronic Co Ltd

MKP62 Series 470nF maximum, 250V, X2 110°C FOWX2 (E186600)

UL

C7 and C8 X Capacitors (Optional) (Alternative5)

Okaya electric industries Co Ltd

LE-MX Series 470nF maximum, 250V, X2 110°C FOWX2 (E47474) UL

C12, C13 Y Capacitors (Optional)

Evox Rifa AB (Kemet)

PHE850 Series 4.7nF maximum, 250V, Y2, 110°C FOWX2 (E73869) UL

C12, C13 Y Capacitors (Optional) (Alternative1)

ISKRA Kondenzatorji D D

KNB2520 4.7nF maximum, 250V, Y2, 100°C FOWX2 (E145156)

UL

C12, C13 Y Capacitors Evox Rifa AB PME271Y 4.7nF maximum, 250V, Y2, 100°C FOKY2 UL

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2016-02-01

Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

(Optional) (Alternative2) (Kemet) (E100117)

C12, C13 Y Capacitors (Optional) (Alternative3)

Wima Wilhelm Westermann Spezialvertrieb

Elektronischer

MP3-Y2 Series 4.7nF maximum, 250V, Y2, 110°C FOKY2 (E100438)

UL

C12, C13 Y Capacitors

(Optional) (Alternative4)

Xiamen Faratronic

Co Ltd

MKP63 Series 4.7nF maximum, 250V, Y2, 105°C FOWX2

(E186600)

UL

C12, C13 Y Capacitors

(Optional) (Alternative5)

Vishay (BC

Components)

MKP338-6 4.7nF maximum, 300V, Y2, 105°C FOWX2

(E112471)

UL

C12, C13 Y Capacitors

(Optional) (Alternative6)

Murata

MFG Co. Ltd.

KY 4.7nF maximum, 250V, Y2, 125°C FOWX2 (E37921) UL

C12, C13 Y Capacitors

(Optional) (Alternative7)

Murata

MFG Co. Ltd.

KX series 4.7nF maximum, 250V, Y1, 125°C FOWX2 (E37921) UL

C14 Y Capacitor

(Optional)

Evox Rifa AB

(Kemet)

ERP 610 Series 4.7nF maximum, 250V, Y1, 125°C FOWX2 (E73869) UL

C14 Y Capacitor

(Optional) (alternate 2)

Murata

MFG Co. Ltd.

KY or KX series 4.7nF maximum, 250V, Y2, 125°C FOWX2 (E37921) UL

C15, C19 secondary Y

capacitor (optional)

Vishay (BC

Components)

338-6 10nF maximum, 300V, Y2, 105°C FOWX2

(E109565)

UL

C15, C19 secondary Y

capacitor (optional) (alternative 1)

Evox Rifa Group OYJ ERO 610 Series 10nF maximum, 250V, Y2, 125°C FOWX2 (E73869) UL

C15, C19 secondary Y capacitor (optional) (alternative 2)

Xiamen Faratronic Co Ltd

MKP63 Series 10nF maximum, 250V, Y2, 105°C FOWX2 (E186600)

UL

C15, C19 secondary Y capacitor (optional)

(alternative 3)

Murata KY 10nF maximum, 250V, Y2, 125°C FOWX2 (E37921) UL

C15, C19 secondary Y

capacitor (optional) (alternative 4)

Murata

MFG Co. Ltd.

KX series 4.7nF maximum, 250V, Y1, 125°C FOWX2 (E37921) UL

L1 and L2 common Various Various Cores: OD 22mm, ID 14mm, Depth 8mm Base: QMTS2 -

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Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

mode choke Wire:

Class H 0.6mm min. ECW Base:- Various manufacturers, Nema FR4, 1.6mm

94V-0, RTI 130°C

Assessed in-application

L5 Earth Choke

(optional)

Various Various model

numbers.

Wire:

Class H 1.4mm diameter minimum ECW

Assessed in-

application

-

L5 Earth Choke – wire

link (optional) (alternate)

Various Various Optional wire link – in place of L5.

1.4mm diameter minimum; copper or tinned copper.

Assessed in-

application

-

L3 Boost Choke Various Various model numbers.

PQ Cores : 26mm x 25mm x 19mm Wire:

Class F 24x0.127mm and 0.3mm ECW Bobbin: Manufactured by Sumitomo Bakelite

PM9820, 0.7mm 94V-0, RTI 150°C (This choke is not mounted on the main PWB; a Tmax of 140° is applied by the manufacturer.)

Bobbin: QMFZ2 Assessed in-application

-

L6 primary resonant choke (24V, 28, 40 and

48V model only)

Various Various model numbers

Cores: OD 8mm, ID 4mm, Depth 3mm

Wire: Class H 0.4mm min. ECW.

Base:- Manufactured by EI Dupont Rynite FR530 or FR530L, 0.8mm thick rated 94V-0, RTI 155°C

Base: QMFZ2 Assessed in-

application

-

L6 primary resonant choke, covered with 2

layers of heatshrink (24V, 28, 40 and 48V model only) (alternate)

Various Various model numbers

Cores: OD 8mm, ID 4mm, Depth 3mm

Wire: Class H 0.4mm min. ECW

Base: QMTS2 Assessed in-

application

-

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Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

Base:- Various manufacturers, Nema FR4, 1.6mm 94V-0, RTI 130°C

C9 Reservoir Capacitor Various Various 120uF maximum, 400V minimum, 105°C Assessed in-application

-

EFE300MJ-12-5-006 C4 Reservoir Capacitor

Various Various 120uF maximum, 400V minimum, 105°C Assessed in-application

-

TX2 transformer TDK-Lambda UK Ltd or Trio Engineering

Co Ltd

TDKL Part No: 33567, 33599,

33568, 33611, 33606, 33608. Components

manufactured by Trio Engineering Co have been

identified by the suffix 'T'

Class F Reinforced insulation, system CEL-CF4 or TEC-CF4

OBJY3 UL

TX2 transformer bobbin Various TDKL Part No: 60313

Manufactured by EI Dupont Rynite FR530 or FR530L, 0.8mm thick rated 94V-0, RTI 155°C

QMFZ2 (E41938) UL

TX2 transformer cradle Various TDKL Part No: 60721

Manufactured by EI Dupont Rynite FR530 or FR530L, 0.8mm thick rated 94V-0, RTI 155°C

QMFZ2 (E41938) UL

TX2 transformer cores Various Various Cores: two sets, 30mm x 30mm x 9mm Assessed in-application

-

TX2 transformer triple insulated wire (pri aux winding)

New England Wire Technologies Corporation

W26T1.5xxxETC1x (Where x may be replaced with a

letter or number)

Triple insulated wire 26AWG (0.4mm diameter) minimum. Provides reinforced insulation. Class F

OBJT2 (E205791) UL

TX2 transformer triple

insulated wire (pri winding)

New England Wire

Technologies Corporation

W26T2.0xxxEMW

80S19x (where x may be replaced with a letter or

number)

Triple insulated wire 26AWG (19x0.1mm diameter)

Provides reinforced insulation. Class F

OBJT2 (E205791) UL

TX2 transformer (Ch1

24V and 28V winding)

Various Winding wire Winding wire: Litz wire, NELB96/38HNUL OBMW2 UL

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Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

TX2 transformer (Ch1 12V winding)

Various Winding wire Winding wire: Litz wire, NELC240/38HNUL OBMW2 UL

TX2 transformer (Ch1 40V and 48V winding)

Various Winding wire Winding wire: Litz wire, NELB64/38HNUL OBMW2 UL

TX2 transformer (sec aux winding)

Various Winding wire Winding wire: 0.55mm min OBMW2 UL

EFE300MJ-12.1-5-008 and/or –SGP TX2

transformer TX2 (CH1 12V)

TDK-Lambda UK Ltd or Trio Engineering

Co Ltd

TDKL Part No: 33648.

Components manufactured by Trio Engineering

Co have been identified by the suffix 'T'

Class F Reinforced insulation, system CEL-CF2 or TEC-CF2 or NLF1

OBJY3 UL

EFE300MJ-12.1-5-008 and/or –SGP TX2

transformer triple insulated wire (pri aux winding)

Totoku 3S-ETFE Triple insulated wire 26AWG min. Provides reinforced insulation. Class F

OBJT2 (E166483) UL

EFE300MJ-12.1-5-008 and/or –SGP TX2

transformer triple insulated wire (pri winding)

Totoku 3S-ETFE Triple insulated wire 22AWG min. Provides reinforced insulation. Class F

OBJT2 (E166483) UL

EFE300MJ-12.1-5-008 and/or –SGP TX2

transformer (Ch1 12V winding)

Various Winding wire Winding wire size: 24x10x0.1mm diameter. Class F OBMW2 UL

J2 output terminal block (18Way)

Various Various 60V (Minimum), 6A (minimum) ECBT2 UL

L4 output choke Various Various model numbers.

Core : 20mm x 6mm. Base: Various manufacturers, Nema FR4, 1.6mm 94V-0

Base: QMTS2 Assessed in-application

-

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Issue Date: 2012-10-26 Page 13 of 17 Report Reference # E349607-A34-UL

2016-02-01

Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

U2, U4, U5, U6. opto-coupler

Vishay SFH615A-3-X006 (system H or J)

4420Vac FPQU2 (E52744) UL

U2, U4, U5, U6. opto-coupler Alternative 1

Renesas Electronics Corporation

PS2581L1 5000Vac May be marked NEC and/or Renesas

FPQU2 (E72422) UL

U2, U4, U5, U6. opto-coupler Alternative 2

Renesas Electronics Corporation

PS2561L1-1 5000Vac May be marked NEC and/or Renesas

FPQU2 (E72422) UL

U2, U4, U5, U6 opto-coupler Alternative 3

Renesas Electronics Corporation

PS2561DL1-1 5000Vac May be marked NEC and/or Renesas

FPQU2 (E72422) UL

XTH11 Thermistor 40V model (ch1)

Murata PRF18BA471+++++ (+ Can be any

letter or number)

4.7Kohm at 125°C XGPU2 (E137188)

UL

XTH11 Thermistor 48V

model (ch1)

Murata PRF18BB471+++

++ (+ Can be any letter or number)

4.7Kohm at 115°C XGPU2

(E137188)

UL

XTH11 Thermistor up to and including 28V model (ch1)

Murata PRF18AR471+++++ (+ Can be any letter or number)

4.7Kohm at 135°C XGPU2 (E137188)

UL

XTH11 Thermistor up to and including 28V model

(ch1) (alternate 1)

Murata PRF18BA471+++++ (+ Can be any

letter or number)

4.7Kohm at 125°C XGPU2 (E137188)

UL

XTH11 Thermistor up to

and including 28V model (ch1) (alternate 2)

Murata PRF18BB471+++

++ (+ Can be any letter or number)

4.7Kohm at 115°C XGPU2

(E137188)

UL

XTH12 Thermistor (nr XD34 and XD35)

Murata PRF18AR471+++++ (+ Can be any letter or number)

4.7Kohm at 135°C XGPU2 (E137188)

UL

XTH12 Thermistor (nr XD34 and XD35)

(alternate 1)

Murata PRF18BA471+++++ (+ Can be any

letter or number)

4.7Kohm at 125°C XGPU2 (E137188)

UL

XTH12 Thermistor (nr

XD34 and XD35) (alternate 2)

Murata PRF18BB471+++

++ (+ Can be any letter or number)

4.7Kohm at 115°C XGPU2

(E137188)

UL

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Issue Date: 2012-10-26 Page 14 of 17 Report Reference # E349607-A34-UL

2016-02-01

Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

XTH201 Thermistor (IMS)

Murata PRF18BB471+++++ (+ Can be any

letter or number)

4.7Kohm at 115°C XGPU2 (E137188)

UL

Chassis side insulation Various Various 115mm by 36mm min. polyester or polyimide tape.

Provides Basic insulation

OANZ2 UL

Cover insulation Various Various 150mm by 82mm min with cut-outs polyester or

polyimide tape. Provides Basic insulation

OANZ2 UL

Chassis base Various Various 150mm by 82mm min with cut-outs polyester or

polyimide tape. Provides Basic insulation

OANZ2 UL

Fan Sunonwealth Sunon

PMD1204PKB3. Series

40mm, 12V, 13.3cfm, 20mm thick GPWV2 (E77551) UL

Sleeving on fan leads, TX2, L6 (2 layers) and L5

Various Various 300V (Minimum)125°C (Minimum), VW-1 (minimum)

YDPU2 UL

Non-conformal coatings (Optional) May be

applied over all areas of PSU

Humiseal Div of Chase Corp.

1H2OAR1 Water based acrylic coating rated 125°C QMJU2 (E105698)

UL

Non-conformal coatings (Optional) May be applied over all areas of

PSU

Humiseal Div of Chase Corp.

1A27 Polyurethane coating rated 125°C QMJU2 (E105698)

UL

Non-conformal coatings

(Optional) May be applied over all areas of PSU

James Briggs HLX16 (069258) Acrylic anti-corona coating rated 150°C.

(Previously assessed in application via application of UL/IEC60950-1 Annex A2)

- -

Non-conformal coatings (Optional) May be

applied over all areas of PSU

Humiseal Div of Chase Corp.

1A49 LV Polyurethane coating rated 200°C QMJU2 (E105698)

UL

Non-conformal coatings (Optional) May be

J. C. Dolph AC43 Varnish 180°C QMJU2 (E317427)

UL

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Issue Date: 2012-10-26 Page 15 of 17 Report Reference # E349607-A34-UL

2016-02-01

Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

applied over all areas of PSU

TX1 TDK-Lambda UK Ltd or Trio Engineering

Co Ltd

TDKL Part No: 33507 33565,

33597, 33598. Components manufactured by

Trio Engineering Co have been identified by the

suffix 'T'

Class F Reinforced insulation, systems CEL-CF4 or TEC-CF4 or CEL-CF2 or TEC-CF2 or NLF1

OBJY3 UL

TX1 bobbin Various TDKL Part No:

20143

Manufactured by EI Dupont Rynite FR530 or

FR530L, 0.8mm thick rated 94V-0

QMFZ2 (E41938) -

TX1 triple insulated wire New England Wire

Technologies Corporation

W26T1.5xxxETC1

x (Where x may be replaced with a letter or number)

Triple insulated wire 26AWG (0.4mm diameter)

minimum. Provides reinforced insulation. Class F

OBJT2 (E20591). UL

TX1 triple insulated wire Alternative 1

Totoku 3S-ETFE or TIW-E

Triple insulated wire. 26 AWG (0.4mm dia.) minimum. Provides reinforced insulation Class F

OBJT2 (E166483).

UL

Secondary 12V 1A fan supply

XL601 or XL701 output choke

Various Various model numbers.

Core: 12mm x 12mm Assessed in-application

-

XF1 or F2 Schurter OMF250 F1A 250V JDYX2 (E41599) UL

XF1 or F2 Alternative 1 Bussmann PCB tron F1A 450V JDYX2 (E19180) UL

XF1 or F2 Alternative 2 Daito DCP10 F1A 450V JDYX2 (E59783) UL

XF1 or F2 Alternative 3 Hollyland (Xiamen) 5EF F1A 250V JDYX2 (E15641) UL

Air guide Sabic Innovative

plastics BV

Lexan FR700 105mm by 28mm with fold and cut-outs. 94V-0,

0.25mm thick.

QMFZ2

(E103380)

UL

Air guide Various Various 105mm by 28mm with fold and cut-outs. 94V-0,

0.25mm thick.

QMFZ2 UL

Insulator optional Sabic Innovative Lexan FR700 71mm by 28.5mm with folds 94V-0, 0.25mm thick. QMFZ2 UL

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Issue Date: 2012-10-26 Page 16 of 17 Report Reference # E349607-A34-UL

2016-02-01

Object/part or Description

Manufacturer/ trademark

type/model technical data CCN Marks of Conformity

plastics BV (E103380)

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Issue Date: 2012-10-26 Page 17 of 17 Report Reference # E349607-A34-UL

2016-02-01

Enclosures

Type Supplement Id Description

Photographs 3-01 EFE300M PSU with HN fan/case option

Photographs 3-02 EFE300M PSU with HU fan/case option

Photographs 3-03 EFE300M PSU with HC fan/case option

Photographs 3-04 EFE300M PSU with EC fan/case option

Photographs 3-05 EFE300M new filter layout (1)

Photographs 3-06 EFE300M new filter layout (2)

Photographs 3-07 EFE300MJ-12-5-006

Photographs 3-08 EFE300MJ-12.1-5-008 fan assembly

Diagrams 4-01 Transformer diagrams

Diagrams 4-02 Transformer diagrams update

Schematics + PWB 5-01 PWB standard model

Schematics + PWB 5-02 Y50029#

Schematics + PWB 5-03 EFE300MJ-12-5-006

Schematics + PWB 5-04 EFE300MJ-12.1-5-008

Schematics + PWB 5-05 IMS PWB

Manuals 6-01 Handbook

Miscellaneous 7-01 Multiple manufacturers declaration

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File E349607 Vol. X5, X2, X1 Sec. A34, A34, A34 PHO-01 Issued: 2012-

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File E349607 Vol. X5, X2, X1 Sec. A34, A34, A34 PHO-02 Issued: 2012-

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File E349607 Vol. X5, X2, X1 Sec. A34, A34, A34 PHO-03 Issued: 2012-

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File E349607 Vol. X5, X2, X1 Sec. A34, A34, A34 PHO-04 Issued: 2012-

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Issue Date: 2012-10-26 Page 1 of 3 Report Reference # E349607-A34-UL

Revision Date: 2016-02-01 Test Record

Test Record No. 1 The models EFE300M (12V CH1 output), EFE300M (40V CH1 output), EFE300M (48V CH1 output),

EFE300M-13.2-0-ECMDL-NN, EFE300M-13-5-HNMDL-NT-S were used for test purposes and considered representative of the entire series.

The following tests were conducted:

Test Testing Location/Comments

Power Input Test (4.11)

Humidity Preconditioning Treatment (5.7)

Working Voltage Measurement (8.5.4)

Earthing and Potential Equalization Test (8.6.4a)

Dielectric Voltage Withstand (8.8.3)

Temperature Test (11)

Abnormal Operation and Single Fault Conditions (13)

Transformer Overload and Short-Circuit Tests (15.5.1)

Transformer Dielectric Voltage Withstand (15.5.2)

Test results are valid only for the tested equipment. These tests are considered representative of the products covered by this Test Report. The test methods and results of the above tests have been reviewed and found to be in accordance with the requirements in the Standard(s) referenced at the beginning of this Test Report.

The following supplements are provided as a part of this Test Record. NOTE: These supplements are only

available to the Applicant via the CDA system.

Type Supplement Id Description

Datasheet 2-01 Datasheets

Insulation Diagram 10-01 Insulation Diagram

Insulation Table 10-02 Insulation Table

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Revision Date: 2016-02-01 Test Record

Test Record No. 2 Testing was not considered necessary based on the results of previous investigation to evaluate the use of

alternate Printed Wiring Board to critical components table, manufactured by MFS Technology (PCB) type MDL10 and Toshiba Opto-coupler type TLP785F.

The following tests were waived:

Test Rationale for Waiving

Dielectric Voltage Withstand (8.8.3) Alternate Toshiba Opto-coupler type TLP785F previouly certified

Thermal Cycling Test for Spaces Filled by Insulating Compound (8.9.3)

Alternate Printed Wiring Board tested to IEC/UL 60950-1 2nd ed + Am 1,

clauses 2.10.11, 2.10.9

Temperature Test (11) Based on the results of previous investigation and rated junction temperature of the Toshiba

Opto-coupler type TLP785F

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Revision Date: 2016-02-01 Test Record

Test Record No. 3 Testing was not considered necessary based on the results of previous investigation.

This evaluation included LoCC corrections as below: F2 Alternative 2 - DCP F1corrected to DCP10, 450 V, 1A L5 Earth choke - core dimensions removed