CERTIFICATE OF COMPLIANCE
Certificate Number
Report Reference
Issue Date
Issued to:
20140318-E188913
E188913-A31-UL
2014-MARCH-18
TRACO ELECTRONIC AG
SIHLBRUGGSTRASSE 111, CH-6340 BAAR SWITZERLAND
This is to certify that
representative samples of
COMPONENT - POWER SUPPLIES, MEDICAL AND DENTAL
AC/DC Power Module - Models TMM 60aX (where a can be 105,
112, 115, 124, 148; X can be C or blank)
Have been investigated by UL in accordance with the
Standard(s) indicated on this Certificate.
Standard(s) for Safety:
ANSI/AAMI ES60601-1 (2005 + C1:09 + A2:10) and CAN/CSAC22.2 No. 60601-1 (2008) - Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential
Performance
Additional Information:
See the UL Online Certifications Directory at
www.ul.com/database for additional information
Only those products bearing the UL Recognized Component Marks for the U.S. and Canada should be
considered as being covered by UL's Recognition and Follow-Up Service and meeting the appropriate U.S. and
Canadian requirements.
The UL Recognized Component Mark for the U.S. generally consists of the manufacturer’s identification and
catalog number, model number or other product designation as specified under “Marking” for the particular
Recognition as published in the appropriate UL Directory. As a supplementary means of identifying products that
have been produced under UL’s Component Recognition Program, UL’s Recognized Component Mark:
, may
be used in conjunction with the required Recognized Marks. The Recognized Component Mark is required when
specified in the UL Directory preceding the recognitions or under “Markings” for the individual recognitions. The
and the
UL Recognized Component Mark for Canada consists of the UL Recognized Mark for Canada:
manufacturer’s identification and catalog number, model number or other product designation as specified under
“Marking” for the particular Recognition as published in the appropriate UL Directory.
Recognized components are incomplete in certain constructional features or restricted in performance
capabilities and are intended for use as components of complete equipment submitted for investigation rather
than for direct separate installation in the field. The final acceptance of the component is dependent upon its
installation and use in complete equipment submitted to UL LLC.
Look for the UL Recognized Component Mark on the product.
William R. Carney, Director, North American Certification Programs
UL LLC
Any information and documentation involving UL Mark services are provided on behalf of UL LLC (UL) or any authorized licensee of UL. For questions, please
contact a local UL Customer Service Representative at www.ul.com/contactus
Page 1 of 1
Issue Date:
2014-03-14
Page 1 of 15
Report Reference #
E188913-A31-UL
UL TEST REPORT AND PROCEDURE
Standard:
Certification Type:
CCN:
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)
Component Recognition
QQHM2, QQHM8 (Power Supplies, Medical and Dental)
AC/DC Power Module
Models TMM 60aX (where a can be 105, 112, 115, 124, 148; X can be
C or blank)
Input: 100-240Vac, 60/50 Hz, 1.5A- 0.8A
Product:
Model:
Rating:
Output:
Models
TMM 60105X
TMM 60112X
TMM 60115X
TMM 60124X
TMM 60148X
Applicant Name and Address:
Output
5.1 V dc, 10.0 A
12 V dc, 5.0 A
15 V dc, 4.0A
24 V dc, 2.5A
48 V dc, 1.25 A
TRACO ELECTRONIC AG
SIHLBRUGGSTRASSE 111
CH-6340 BAAR SWITZERLAND
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 UL LLC ('UL') in accordance with the FollowUp 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 UL LLC (UL) or any authorized licensee of UL.
Prepared by:
Sharon Hsu
Reviewed by: Chenchen Lee
Copyright © 2014
Issue Date:
2014-03-14
Page 2 of 15
Report Reference #
E188913-A31-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:
2014-03-14
Page 3 of 15
Report Reference #
E188913-A31-UL
Product Description
The unit is an open frame power supply, and all electrical components inside power supply are mounted on
PWB and insulating compound completely fills the casing of power supply.
The unit is intended to produce varieties of output voltage at max ambient temperature 60 degree C. The
power supply can be employed to operate at ambient 75 degree C, but the max output load is derated to
50% max output loading; at ambient 80 degree C, but the max output load is derated to 25% max output
loading.
The risk management requirements of the standard were not addressed.
Model Differences
Models TMM 60aX (where a can be 105, 112, 115, 124, 148; X can be C or blank)
“a” can be 105, 112, 115, 124, 148 denotes single output voltage 5.1V, 12V, 15V, 24V and 48V.
“X” can be C, denote unit with terminal block; blank denote unit without terminal block.
Model TMM 60aC are similar to model TMM 60a except enclosure used with terminal block
All models are similar except for model designations, output power, output voltage, PWB layout and
transformer.
PCB Layout type A for Model TMM 60105, TMM 60105C ;
PCB Layout type B for Model TMM 60112, TMM 60112C, TMM 60115, TMM 60115C, TMM 60124, TMM
60124C, TMM 60148, TMM 60148C
Output:
Models
TMM 60105X
TMM 60112X
TMM 60115X
TMM 60124X
TMM 60148X
Output
5.1 V dc, 10.0 A
12 V dc, 5.0 A
15 V dc, 4.0A
24 V dc, 2.5A
48 V dc, 1.25 A
Technical Considerations
§
Classification of installation and use : AC/DC Power Module for building in
§
Device type (component/sub-assembly/ equipment/ system) : Component
§
Intended use (Including type of patient, application location) : R/C component, to be defined in the
end product
§
Mode of operation : Continuous
§
Supply connection : R/C component, terminal block or pin
§
Accessories and detachable parts included : None
§
Other options include : None
§
The product was investigated to the following additional standards:: IEC 60601-1:2005; , EN 606011: 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
Issue Date:
2014-03-14
Page 4 of 15
Report Reference #
E188913-A31-UL
Deviations for United States); , ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R)2012 and A2:2010/(R)2012; , IEC 60601-1:2005;
CORR1:2006;CORR2:2007;AMD1:2012, EN 60601-1:2006/A1:2013,
§
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 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
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:
§
This power supply has been judged on the basis of the required creepage and clearances in the First
Edition of the Standard for Medical Electrical Equipment, ANSI/AAMI ES60601-1, Sub clause 8.9.
§
This power supply has been evaluated as a Class II, 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. An additional evaluation shall be made if the power supply is intended for use in
other than Class II equipment.
§
Consideration shall be given to measuring the temperatures on power electronic components and
transformer windings when the power supply is installed in/with the end use equipment. Transformer,
T1, employs a Class B (130) insulation system.
§
Considerations to the applied parts requirement, to be conducted as end product.
§
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. The end-use
product shall ensure that the power supply is used within its ratings.
§
The output circuits have not been evaluated for direct patient connection (Type B, BF or CF).
§
The power supply was evaluated as 2 MOPP between Primary and Secondary. Transformer T1 with
triple insulation wire in secondary, core was treated as Primary.
§
The insulating compound completely fills the casing of power supply, and minimum 0.4 mm
distances through insulation to provide required creepage and clearance.
§
Temperature, Leakage Current, Dielectric Voltage Withstand, Voltage or Charge Limitation, and
Interruption of the Power Supply tests should be considered as part of the end product evaluation.
§
The max ambient temperature 60 degree C. The power supply can be employed to operate at
ambient 75 degree C, but the max output load is derated to 50% max output loading; at ambient 80
degree C, but the max output load is derated to 25% max output loading.
§
The products were tested on a 20 A branch circuit. If used on a branch circuit greater than this,
additional testing may be necessary.
§
The reference voltage for Dielectric Voltage Test in End Product: 318Vrms, 656Vpk for T1.
§
A suitable Mechanical, Electrical and Fire enclosure shall be provided in the end use product.
§
End product Risk Management Process to include consideration of requirements, specific to the
Power Supply.
§
End product Risk Management Process to consider the need for simultaneous, fault condition
testing.
Issue Date:
2014-03-14
Page 5 of 15
Report Reference #
E188913-A31-UL
§
End product Risk Management Process to consider the need for different orientations of installation
during testing.
§
End product to determine the acceptability of risk in conjunction to insulation to resistance to heat.
§
End product to determine the acceptability of risk in conjunction to the movement of components as
part of the power supply.
§
End product to determine the acceptability of risk in conjunction to the movement of conductors as
part of the power supply.
§
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.
§
Temperature Test was conducted without Test Corner. End product to determine the acceptability of
risk in conjunction to temperature testing without test corner as part of the power supply.
§
For models TMM 60aC with terminal block, the insulation distance (2MOPP) between primary small
PCB to plastic case is insufficient and end product shall provide suitable electrical enclosure and
evaluate CR/CL.
§
Overcurrent releases of adequate breaking capacity must be employed in the end product.
Additional Information
The risk management requirements of the standard were not addressed.
Additional Standards
The product fulfills the requirements of: 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); ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012; IEC 60601-1:2005; CORR1:2006;CORR2:2007;AMD1:2012 EN 60601-1:2006/A1:2013
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
Class II equipment
Power Input
Amps, VA, or Watts
Output
Rated output voltage, power, frequency.