Enclosure - Recom International Power Gmbh

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Page 1 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
TEST REPORT
UL 60601-1
Medical Electrical Equipment
Part 1: General requirements for safety
Applicant's name ........................ :
Recom Manufacturing and Trading Ltd,
Address ......................................... :
2F, No. 206, Feng Jen Road, Feng Shan, Kaohsiung County, Taiwan,
R.O.C
Standards ........................................ : IEC 60601-1:1988 + A1:1991 + A2:1995 + 1995, mod.
EN 60601-1:1990 + A1, A11, A12:1993 + A2:1995 + A13 :1996
Test procedure ................................. : Test Report
Non-standard test method ............... : N/A
Testing Laboratory ........................ :
Superior Product Consulting, Inc.
Address ......................................... :
3rd Fl, 10 Alley 6, Lane 235 Pao Chiao Rd, Hsin-Tien, Taipei, Taiwan
Product ............................................ : Component Type DC to DC Converter, PCB mount, use in medical
equipment
Trademark ....................................... : RECOM
Model and/or type reference ............ : Refer to page. 2
Rating(s) .......................................... : Refer to page. 2
Report Reference No........................ : SPC 1005039
Compiled by ..................................... :
Tim Lu
Reviewed by .................................... :
Peter Lai
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Page 2 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
Ratings and principal characteristics / Model / Type Ref.
Models RXXP2YYSZA/R$, RXXP2##DZA/R$, RV-XXYYSZA/R$, RV-XX##DZA/R$, RXXPBBSZA/R$ and
RXXPCCDZA/R$ series;
Series
RXXP2YYSZA/R$,
RXXP2##DZA/R$,
RV-XXYYSZA/R$,
RV-XX##DZA/R$
XX value (Input Voltage, V dc)
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
XX value (Input Voltage, V dc)
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
YY value
3.3
05
09
12
15
## value
3.3
05
09
12
15
Output rating
3.3 Vdc / 606 mA, 2W
5 Vdc / 400 mA, 2W
9 Vdc / 222 mA, 2W
12 Vdc / 167 mA, 2W
15 Vdc / 133 mA, 2W
Output rating
±3.3 Vdc / ±303 mA, 2W
±5 Vdc / ±200 mA, 2W
±9 Vdc / ±111 mA, 2W
±12 Vdc / ±83 mA, 2W
±15 Vdc / ±66 mA, 2W
Series
RXXPBBSZA/R$,
RXXPCCDZA/R$
XX value (Input Voltage, V dc)
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
XX value (Input Voltage, V dc)
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
3.3, 05, 09, 12, 15, 24
BB value
3.3
05
09
12
15
CC value
3.3
05
09
12
15
Output rating
3.3 Vdc / 303 mA, 1W
5 Vdc / 200 mA, 1W
9 Vdc / 111 mA, 1W
12 Vdc / 84 mA, 1W
15 Vdc / 66 mA, 1W
Output rating
±3.3 Vdc / ±152 mA, 1W
±5 Vdc / ±100 mA, 1W
±9 Vdc / ±56 mA, 1W
±12 Vdc / ±44 mA, 1W
±15 Vdc / ±33 mA, 1W
Notes:
1. Type of protection against electric shock: Reinforced Insulation.
2. Degree of protection against electric shock: Not Classified.
3. Degree of protection against ingress of water: IPX0.
4. Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with
oxygen or nitrous oxide:
Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen
or nitrous oxide.
5. Mode of operation: Continuous
6. Environmental Conditions: Normal: 10-40°C, 30-75% RH, 700-1060 hPa.
7. The subject model can be operated at an ambient temperature 85 °C max.
8. “Z” in the model designation denotes /P or blank for continuous short circuit protection.
9. “A” in the model designation denotes /X1 for non-standard nominal deviation; /X2 for reduced pinout; /X3
for reduced power;
/X4 for reduced quiescent current; /X5 for reduced inrush current; /X6 for non-standard isolation test; /X7
for non-standard operating frequency; or blank.
10. “$” in the model designation denotes 6.4 for 3000 V ac testing value of Electric Strength; 8 for 5000 V ac
testing value of Electric Strength.
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Page 3 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
GENERAL INFORMATION
Test item particulars (see also clause 5):
Classification of installation and use ........................ :
Component for building-in.
Supply connection .................................................... :
To be evaluated in end product.
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 ........................................... :
DI
RI
- 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:
The power transformer, T1, is wrapped with three layers of insulation tape with 15 mm width and keep
minimum 5.5 mm of creepage distance and clearance between Core of T1 and output side when core is
considered input side or between Core of T1 and input side when core is considered output side.
The equipment is evaluated for maximum ambient temperature 85 °C.
The maximum leakage current of equipment = 1.4 uA which is comply with allowable values of Type BF in
clause Table IV.
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Page 4 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
3
GENERAL REQUIREMENTS
Pass
3.1
Equipment when transported, stored, installed,
The equipment causes no
operated in normal use and maintained according hazards when used according
to the instructions of the manufacturer, causes no the manufacturers instructions.
safety hazard which could reasonably be foreseen
and which is not connected with its intended
application in normal condition (N.C.) and in single
fault condition (S.F.C.)
Pass
3.4
An alternative means of construction is used to that No alternative construction.
detailed in this standard and it can be
demonstrated that an equivalent degree of safety is
obtained
N/A
5
CLASSIFICATION
Pass
5.1
Type of protection against electric shock
Pass
Class I equipment
N/A
Class II equipment
N/A
Internally powered equipment
5.2
Reinforced Insulation
Pass
Degree of protection against electric shock
Pass
Type B applied part
N/A
Type BF applied part
N/A
Type CF applied part
N/A
Not classified - no applied parts
No applied parts.
Pass
5.3
Classification according to the degree of protection Ordinary protection: IPX0
against ingress of water as detailed in the current
edition of IEC 529 (see 6.1.1) ................................:
Pass
5.4
Methods of sterilization or disinfection
Not required.
N/A
5.5
Equipment not suitable for use in the presence of
flammable mixtures
The equipment is not classified
as category AP or APG.
N/A
Category AP equipment
Not AP or APG equipment
N/A
5.6
Category APG equipment
N/A
Mode of operation:
Pass
-continuous operation
The equipment is designed for
continuous operation.
Pass
-short-time operation, specified operation; period..:
-
-intermittent operation, specified operation; rest
period .....................................................................:
-
-continuous operation with short-time, stated
permissible loading time.........................................:
-
-continuous operation with intermittent, stated
-
鼎安科技股份有限公司
Page 5 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
permissible loading/rest time..................................:
INSULATION DIAGRAM
Not provided due to operation insulation is provided in the EUT
鼎安科技股份有限公司
SUPERIOR PRODUCT CONSULTING, INC
Page 6 of 57
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 7 of 57
SUPERIOR PRODUCT CONSULTING, INC
6
IDENTIFICATION, MARKING AND DOCUMENTS
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
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Page 8 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
6.1
Marking on the outside of equipment or equipment parts
Pass
6.1c
Markings of the specific power supply affixed
Pass
6.1d
If marking is not practicable due to size or nature of
enclosure, information is included in accompanying
documents
N/A
6.1e
Name and/or trademark of the manufacturer or
RECOM
supplier...................................................................:
Pass
6.1f
Model or type reference .........................................: See page. 2 for details.
Pass
6.1g
Rated supply voltages or voltage range(s)
Pass
The information (manufacturer,
model name) of approved
external power adaptor was
provided on the label and in
the accompany document as
well.
See page. 2 for details.
Number of phases ..................................................:
N/A
Type of current .......................................................: DC
Pass
6.1h
Rated frequency or rated frequency range(s) (Hz) : DC input
N/A
6.1j
Rated power input (VA, W or A).............................: See page. 2 for details.
Pass
6.1k
Power output of auxiliary mains socket - outlets
No mains socket-outlet
provided.
N/A
6.1l
Class II symbol
Powered by Class I external
power adaptor.
N/A
Symbol for degree of protection against ingress of IPX0 marked in Instruction
water provided........................................................: Manual.
N/A
Symbol for protection against electric shock..........: No applied part.
N/A
If equipment has more than one applied part with
different degrees of protection, the relevant
symbols are clearly marked on such applied parts,
or on or near relevant outlets
No applied part.
N/A
Symbol for protection of defibrillation-proof applied No applied part.
parts
N/A
Symbol 14 from Table DI for defibrillation-proof with No applied part.
protection partly in patient cable
N/A
6.1m
Mode of operation (if no marking, suitable for
continuous operation)
Pass
6.1n
Types and rating of external accessible fuses .......: To be considered in the end
system.
N/A
6.1p
Ratings of external output: .....................................: See page. 2 for details.
Pass
6.1q
Symbol for physiological effect(s):
N/A
- attention, consult accompanying documents
N/A
- non-ionizing radiation, or symbols as adopted by
ISO or IEC 417
N/A
Anaesthetic-proof symbol: AP or APG ...................: Not AP or APG equipment
N/A
6.1r
Optional,
continuous operation.
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Page 9 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
6.1s
Dangerous voltage symbol
No dangerous voltage.
N/A
6.1t
Special cooling requirements
No special cooling
requirements.
N/A
6.1u
Limited mechanical stability
6.1v
Protective packing requirement(s)
6.1y
6.1z
N/A
No special measures have to
be taken during transport or
storage.
N/A
- Marking(s) for unpacking safety hazard(s)
N/A
- Equipment or accessories supplied sterile,
marked as sterile
N/A
Potential equalization terminal
No such terminal provided.
N/A
- Functional earth terminal
No such terminal provided.
N/A
Removable protective means
No such means.
N/A
Durability of marking test
(see appended table 6.1)
N/A
6.2
Marking on the inside of equipment or equipment parts
Pass
6.2a
Nominal voltage of permanently installed
equipment
Not permanently installed
equipment.
N/A
6.2b
Maximum power loading for heating elements or
holders for heating lamps
No heating lamps
N/A
6.2c
Dangerous voltage symbol
N/A
6.2d
Type of battery and mode of insertion
N/A
- Marking referring to accompanying documents
used for battery not intended to be changed by the
operator
N/A
6.2e
Fuses accessible with a tool identified either by
type and rating or by a reference to diagram
N/A
6.2f
Protective earth terminal
N/A
6.2g
Functional earth terminal
N/A
6.2h
Supply neutral conductor in permanently installed
equipment (N)
6.2j
Markings required in 6.2 f), h), k), and l) remain
No such marking required.
visible after connection and are not affixed to parts
which have to be removed
N/A
- Markings comply with IEC 445
N/A
6.2k
For permanently connected devices the supply
To be considered in the
connections are clearly marked adjacent to the
system.
terminals (or in accompanying documents for small
equipment)
N/A
6.2l
Statement for suitable wiring materials at
temperatures over 75°C
N/A
6.2n
Capacitors and/or circuit parts marked as required
in Sub-clause 15c
N/A
To be considered in the
system.
N/A
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SUPERIOR PRODUCT CONSULTING, INC
6.3
Marking of controls and instruments
6.3a
Mains switch clearly identified
Report No.:SPC 1005039
Issue Date:2010-07-20
N/A
No such parts
N/A
- ON and OFF positions marked according to
Symbols 15 and 16 of table D1 or indicated by an
adjacent indicator light
N/A
6.3b
Indication of different positions of control devices
and switches
N/A
6.3c
Indication of the direction in which the magnitude of No such controls.
the function changes, or an indicating device
N/A
6.3f
The functions of operator controls and indicators
are identified
N/A
6.3g
Numeric indications of parameters are in SI units
except for units listed in Am. 2
N/A
6.4
Symbols
N/A
Used symbols comply with Appendix D or IEC 417
and/or IEC 878 or ISO publications (if applicable)
N/A
6.5
Colors of the insulation of conductors
N/A
6.5a
Protective earth conductor has green/yellow
insulation
To be considered in the
system.
N/A
6.5b
All insulations of internal protective earth
conductors are green/yellow at least at their
terminations
To be considered in the
system.
N/A
6.5c
Only protective or functional earthing, or potential
equalization conductors are green/yellow
To be considered in the
system.
N/A
6.5d
Color of neutral conductor......................................: No direct mains connection.
N/A
6.5e
Colors of phase conductor(s) .................................: No direct mains connection.
N/A
- Compliance with IEC 227 and IEC 245
N/A
6.5f
Additional protective earthing in multi-conductor,
cords are marked green/yellow at the ends of the
additional conductors
N/A
6.6
Medical gas cylinders and connections
N/A
6.6a
In accordance with ISO ISO/R 32
6.6b
Identification of connection point
N/A
6.7
Indicator lights and push-buttons
N/A
6.7a
Red indicator lights used exclusively to indicate a
warning of danger and/or a need for urgent action
N/A
- Yellow used to indicate caution or attention
required
N/A
- Green used to indicate ready for action
N/A
Color red used only for push-buttons by which a
function is interrupted in case of emergency
N/A
6.7b
No gas cylinders or
connections
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
6.8
ACCOMPANYING DOCUMENTS
Pass
6.8.1
Equipment accompanied by documents containing Equipment is provided with
at least instructions for use, a technical description application instruction.
and an address to which the user can refer
Pass
Classifications specified in Clause 5 included in
both the instructions for use and the technical
description
Pass
Considered.
Markings specified in Sub-clause 6.1 included in
the accompanying documents if they have not
been permanently affixed to equipment
N/A
Warning statements and the explanation of warning
symbols provided in the accompanying documents
N/A
6.8.2
Instructions for use
Pass
6.8.2a
General information provided in instructions for use Application instruction
provided.
Pass
- state the function and intended application of the
equipment
Pass
Application instruction
provided.
- include an explanation of: the function of controls,
displays and signals
- the sequence of operation
N/A
Application instruction
provided.
Pass
- the connection and disconnection of detachable
parts and accessories
N/A
- the replacement of material which is consumed
during operation
N/A
- information regarding potential electromagnetic or
other interference and advice regarding avoidance
N/A
- include: indications of recognized accessories,
detachable parts and materials, if the use of other
parts or materials can degrade minimum safety
N/A
- instructions concerning cleaning, preventive
inspection and maintenance to be performed
including the frequency of such maintenance
N/A
General information provided in instructions:
N/A
- information for the safe performance of routine
maintenance
N/A
- parts on which preventive inspection and
maintenance shall be performed by other persons
including the periods to be applied
N/A
- explanation of figures, symbols, warning
statements and abbreviations on the equipment
N/A
6.8.2c
Signal output or signal input parts intended only for
connection to specified equipment described
N/A
6.8.2d
Details about acceptable cleaning, disinfection or
sterilization methods included
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
6.8.2e
Warning statement for mains operated equipment
with additional power source
N/A
6.8.2f
A warning to remove primary batteries if equipment
is not likely to be used for some time
N/A
6.8.2g
Instructions to ensure safe use and adequate
maintenance of rechargeable batteries
N/A
6.8.2h
Identification of specified external power supplies
or battery chargers necessary to ensure
compliance with the requirements of IEC 601-1
N/A
6.8.2j
Identification of any risks associated with the
disposal of waste products, residues, etc.
N/A
- Advice in minimizing these risks
N/A
6.8.3
Technical description
Pass
6.8.3a
All characteristics essential for safe operation
provided
6.8.3b
Required type and rating of fuses utilized in the
mains supply circuit external to permanently
installed equipment
N/A
- Instructions for replacement of interchangeable
and/or detachable parts which are subject to
deterioration during normal use
N/A
Included in the applications
instruction.
Pass
6.8.3c
Instructions or reference information for repair of
equipment parts designated by the manufacturer
as repairable provided
Application instruction
provided.
Pass
6.8.3d
Environmental conditions for transport and storage Application instruction
specified in accompanying documents and marked provided.
on packaging
Pass
7
POWER INPUT
Pass
Power Input Measurements
(see appended table 7)
Pass
10
ENVIRONMENTAL CONDITIONS
Pass
10.1
Equipment is capable while packed for transport or Considered.
storage of being exposed to the conditions stated
by the manufacturer
Pass
10.2.2a
Rated voltage not exceeding 250 V for hand-held
equipment
N/A
Equipment not considered
hand-held.
Rated voltage not exceeding 250 V d.c. or singlephase a.c. or 500 V polyphase a.c. for equipment
up to 4kVA
N/A
Rated voltage not exceeding 500 V for all other
equipment
N/A
Rated input frequency not more than 1kHz
Equipment is DC input.
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
10.2.2b
Internal replaceable electrical power source
specified
N/A
14
REQUIREMENTS RELATED TO CLASSIFICATION
Pass
14.4a
Class l and Class II equipment in addition to basic
insulation provided with an additional protection
Equipment is considered
reinforced insulation.
Pass
14.4b
Equipment supplied from external dc source of
reverse polarity results in no safety hazard
No possibility of reverse
connection. No hazard will be
imposed.
Pass
14.5a
Dual classification for internally powered equipment
with a means of connection to supply mains
14.5b
Internally powered equipment complies with
requirements for Class I or Class II equipment
while connected to supply mains, and with
requirements for internally powered equipment
when not connected
Equipment is not directly
connected with patient.
N/A
14.6c
Applied parts intended for direct cardiac application Equipment is not directly
are of type CF
connected with patient.
N/A
15
LIMITATION OF VOLTAGE AND/OR ENERGY
N/A
15b
Voltage measured one sec after disconnection of
the mains plug does not exceed 60V
N/A
15c
For live parts accessible after equipment has been
de-energized the residual voltage does not exceed
60 V nor residual energy exceed 2 mJ
N/A
Marking provided for manual discharging
N/A
16
ENCLOSURES AND PROTECTIVE COVERS
N/A
16a
Equipment enclosed to protect against contact with Equipment is for building in,
live parts, and with parts which can become live
compliance must be
(finger, pin, hook test)
considered in the end system.
N/A
Insertion or removal of lamps - protection against
contact with live parts provided
N/A
N/A
No lamp in the equipment.
16b
Opening in a top cover positioned that accessibility Equipment is for building in,
of live parts by a test rod is prevented
compliance must be
considered in the end system.
N/A
16c
Conductive parts accessible after the removal of handles, knobs, levers
N/A
- have a resistance of not more than 0.2 Ohm
N/A
- separated from live parts by one of the means
described in Sub-clause 17g
N/A
16d
Parts with voltage exceeding 25V a.c. or 60V d.c.
which cannot be disconnected by external mains
Equipment is for building in,
compliance must be
N/A
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switch or plug protected against contact
16e
Report No.:SPC 1005039
Issue Date:2010-07-20
considered in the end system.
Removable enclosures protecting against contact with live parts
N/A
- Removal possible only with the aid of a tool
N/A
Equipment is for building in,
compliance must be
considered in the end system.
- Use of automatic device making parts not live
when the enclosure is opened or removed
N/A
- Exception 16e applied to the following parts .......:
N/A
16f
Openings for the adjustment of controls using a
tool. The tool not able to touch basic insulation or
any live parts
Equipment is for building in,
compliance must be
considered in the end system.
17
SEPARATION
N/A
17a
Separation method of the applied part from live parts:
N/A
1) basic insulation: applied part earthed
N/A
Equipment is not directly
connected with patient.
Compliance must be
considered in the end-system.
N/A
2) by protectively earthed conductive part (e.g.
screen)
N/A
3) by separate earthed intermediate circuit limiting
leakage current to applied part in event of
insulation failure
N/A
4) by double or reinforced insulation
N/A
5) by protective impedances limiting current to
applied part
N/A
- Additional leakage current test in single fault
conditions
N/A
17c
There is no conductive connection between applied
parts and accessible conductive parts which are
not protectively earthed
N/A
17d
Supplementary insulation between hand-held
flexible shafts and motor shafts (Class I)
N/A
17g
Separation method of accessible parts other than applied parts from live parts:
Pass
1) basic insulation: accessible part earthed
N/A
2) by protectively earthed conductive part (e.g.
screen)
N/A
3) by separate earthed intermediate circuit limiting
leakage current to enclosure in event of insulation
failure
N/A
4) by double or reinforced insulation
N/A
5) by protective impedances limiting current to
accessible part
N/A
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- Additional leakage current test in single fault
conditions
17h
Report No.:SPC 1005039
Issue Date:2010-07-20
CREEPAGE DISTANCE
and/or AIR CLEARANCE
between an ACCESSIBLE
PART and LIVE parts which
does not comply with the
requirements of Sub-clause
57.10 are short-circuited.
The ENCLOSURE LEAKAGE
CURRENT is subsequently
measured as described in
Subclause
19.4.
Refer to appended table 19.
N/A
Arrangements used to isolate defibrillation-proof applied parts so designed that:
N/A
- no hazardous electrical energies appear during a No applied parts
discharge of a cardiac defibrillator
N/A
- after exposure to the defibrillation voltage, the
equipment continues to perform its intended
function
N/A
18
PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL
EQUALIZATION
N/A
18a
Accessible parts of Class I equipment separated
from live parts by basic insulation connected to the
protective earth terminal
N/A
18b
Protective earth terminals suitable for connection to
the protective earth conductor
N/A
18e
Potential equalization conductor
N/A
- Readily accessible
N/A
- Accidental disconnection prevented in normal use
N/A
- Conductor detachable without the use of a tool
N/A
- Power supply cord does not incorporate a
potential equalization conductor
N/A
- Connection means marked with Symbol 9,
Table DI
N/A
For equipment without power supply cord,
impedance between protective earth terminal and
accessible metal part <= 0.1 Ohm
N/A
- For equipment with an appliance inlet, impedance Should be consider in end
between protective earth contact and any
system.
accessible metal part <= 0.1 Ohm
N/A
- For equipment with a non-detachable power
supply cord, impedance between protective earth
pin in mains plug and accessible metal part <= 0.2
Ohm
N/A
18f
鼎安科技股份有限公司
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
18g
If the impedance of protective earth connections
other than in Cl. 18 f) exceeds 0.1 Ohm, the
allowable value of the enclosure leakage current is
not exceeded in single fault condition
N/A
18k
Functional earth terminal not used to provide
protective earthing
N/A
18l
Class II equipment with isolated internal screens
N/A
- insulation of screens and all internal wiring
connected to them is double insulation or
reinforced insulation
N/A
- functional earth terminal clearly marked
N/A
- explanation of functional earth terminal provided
in the accompanying documents
N/A
19
CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS
Pass
19.1b
Leakage currents
Pass
(see appended table 19)
- earth leakage current
20
N/A
- enclosure leakage current
(see appended table 19)
Pass
- patient leakage current
No patient circuits.
N/A
- patient auxiliary current
No patient circuits.
N/A
Pass
DIELECTRIC STRENGTH
Overall compliance with Clause 20
(see appended table 20)
Pass
N/A
21
MECHANICAL STRENGTH
21a
Sufficient rigidity of an enclosure tested by:
force of 45 N
To be considered in the end
system.
N/A
21b
Sufficient strength of an enclosure tested by:
impact hammer
Ditto.
N/A
21c
On portable equipment carrying handles or grips
withstand the requirements of the loading test
N/A
21.3
No damage to parts of patient support and/or
immobilization system after the loading test
N/A
21.5
Hand held equipment or equipment parts are safe
after drop test
N/A
21.6
Portable and mobile equipment is able to withstand
rough handling
Pass
22
MOVING PARTS
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
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22.2a
Moving parts of a transportable equipment are
No moving parts
provided with guards which form an integral part of
the equipment
N/A
22.2b
Moving parts of a stationary equipment are
provided with similar guards as above, unless it is
evident that equivalent protection is separately
provided during installation
N/A
22.3
Cords (ropes), chains and bands are provided with
guides to prevent them from running off or from
jumping out of their guiding devices
N/A
Guides or other safeguards are removable only
with a tool
N/A
22.4
Dangerous movements of equipment parts, which
may cause physical injury to the patient, are
possible only by the continuous activation by the
operator
N/A
22.6
Parts of equipment subject to mechanical wear are
accessible for inspection
N/A
22.7
Means provided for emergency switching of an
electrically produced mechanical movement which
could cause a safety hazard
N/A
The means for emergency switching is readily
identifiable and accessible and does not introduce
a further safety hazard
N/A
Devices for emergency stopping able to break the
full load current of the relevant circuit, taking into
account possible stalled motor currents
N/A
Means for stopping of movements operate as a
result of one single action
N/A
SURFACES, CORNERS AND EDGES
N/A
23
Rough surfaces, sharp corners and edges which
may cause injury or damage avoided or covered
Equipment is for building in.
Compliance must be
considered in the end system.
N/A
24
STABILITY IN NORMAL USE (see appended table 24)
N/A
24.1
Equipment does not overbalance during normal
use when tilted through an angle of 10°
N/A
24.3
Equipment overbalances when tilted through an angle of 10°
N/A
- does not overbalance when tilted through an
angle of 5° in any position excluding transport
N/A
- carry a warning notice stating that transport
should only be undertaken in a certain position
N/A
- in the position specified for transport does not
N/A
鼎安科技股份有限公司
Page 18 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
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overbalance when tilted to an angle of 10°
24.6a
Equipment or its parts with a mass of more than 20 kg is provided with:
N/A
- suitable handling devices (grips etc.), or
N/A
- instructions for lifting and handling during
assembly
N/A
24.6b
On portable equipment with a mass of more than
20 kg carrying handle(s) is (are) so situated that
equipment may be carried by 2 or more persons
N/A
25
EXPELLED PARTS
N/A
25.1
Protective means are provided where expelled
parts of the equipment could be a hazard
N/A
25.2
Display vacuum tubes with a face dimension
exceeding 16 cm are provided with adequate
protection against implosion
N/A
28
SUSPENDED MASSES
N/A
28.3
Suspension system with safety device
N/A
Safety device provided where the integrity of a
suspension depends on parts which may have
hidden defects, or on parts having safety factors
not complying with Sub-clause 28.4
N/A
Safety device has safety factors complying with
Sub-clause 28.4.2
N/A
Clear indication to the operator that the safety
device has been activated after failure of
suspension means
N/A
Suspension systems of metal without safety devices
N/A
1) Total load does not exceed the safe working
load
N/A
2) Safety factors not less than 4 where it is unlikely
that supporting characteristics will be impaired
N/A
3) Safety factors not less than 8 where impairment
is expected
N/A
4) Safety factors multiplied by 1.5 for metal having
an elongation at break of less than 5%
N/A
5) Sheaves, sprockets, band wheels and guides so
constructed that the safety factors maintained till
replacement
N/A
X-RADIATION
N/A
28.4
29
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SUPERIOR PRODUCT CONSULTING, INC
29.2
EQUIPMENT not intended to produce X-radiation
produces an exposure <= 130 nC/kg (0.5 mR)
36
ELECTROMAGNETIC COMPATIBILITY
Equipment complies with IEC 601-1-2
Report No.:SPC 1005039
Issue Date:2010-07-20
Not X-ray equipment
N/A
N/A
EMI/EMC is separately
evaluated and is not part of
this evaluation. Refer to
Conditions of Acceptability.
N/A
COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG
EQUIPMENT
N/A
Requirements for category AP and APG equipment Not AP or APG equipment
(Cl. 37 - 41)
N/A
42
EXCESSIVE TEMPERATURES
Pass
42.1
Equipment does not attain temperatures exceeding (see appended table 42)
the values given in Table Xa over the range of
ambient temperatures per Clause 10.2.1
Pass
42.2
Equipment does not attain temperatures exceeding
the values given in Table Xb at 25°C ambient
Pass
42.3
Applied parts not intended to supply heat have
surface temperatures not exceeding 41°C
No applied parts
N/A
42.5
Guards to prevent contact with hot surfaces
removable only with a tool
No hot accessible surface.
N/A
43
FIRE PREVENTION
37
Strength and rigidity necessary to avoid a fire
hazard
N/A
Equipment is for building in.
Compliance must be
considered in the end system.
N/A
44
OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS,
CLEANING, STERILIZATION AND DISINFECTION
Pass
44.2
Equipment contain a liquid reservoir:
N/A
- the equipment is electrically safe after 15% overfill
steadily over a period of 1 min
N/A
- transportable equipment is electrically safe after
additionally having been tilted through an angle of
15° in the least favorable direction(s) (if necessary
with refilling)
N/A
Electrical properties of the equipment do not
change in connection of spillage test (200 ml of
N/A
44.3
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
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water)
44.4
Liquid which might escape in a single fault
condition does not wet parts which may cause a
safety hazard
N/A
44.5
Equipment sufficiently protected against the effects Considered.
of humidity
Pass
44.6
Enclosures designed to give a protection against
Not protected, IPX0
harmful ingress of water classified according to IEC
Publication 529
N/A
44.7
Equipment capable of withstanding cleaning,
sterilization or disinfection without deterioration of
safety provisions
Pass
45
PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE
N/A
45.2
Pressure vessel with pressure volume greater than No pressure vessels or parts
200 kPa x l and pressure greater than 50 kPa
withstand the hydraulic test pressure
N/A
45.3
Maximum pressure does not exceed the maximum
permissible working pressure for individual parts
N/A
45.7
Unless excessive pressure can not occur,
pressure-relief device provided
N/A
45.7a
a) Pressure-relief device connected as close as
possible to the pressure vessel
N/A
45.7b
b) Readily accessible for inspection
N/A
45.7c
c) Not capable of being adjusted or rendered
inoperative without a tool
N/A
45.7d
d) Discharge opening located that the released
material is not directed towards person
N/A
45.7e
e) Discharge opening located that operation will not
deposit material which may cause a safety hazard
N/A
45.7f
f) Adequate discharge capacity to ensure pressure
does not exceed the maximum permissible working
pressure
N/A
45.7g
g) No shut-off valve between a pressure-relief
device and the parts intended to be protected
N/A
45.7h
h) Minimum number of cycles of operation:
100.000
N/A
48
BIOCOMPATIBILITY
N/A
Parts of equipment and accessories intended to
come into contact with biological tissues, cells or
body fluids are evaluated in accordance with ISO
10993-1
No protection against ingress
of liquid. Should be considered
in end system.
Component. To be evaluated
in end use equipment
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
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49
INTERRUPTION OF THE POWER SUPPLY
49.1
Thermal cut-outs and over-current releases with
automatic resetting not used if they may cause a
safety hazard
49.2
Interruption and restoration of power supply does
not result in a safety hazard other than interruption
of intended function
49.3
Means are provided for removal of mechanical
constraints on patient in case of a supply mains
failure
51
PROTECTION AGAINST HAZARDOUS OUTPUT
51.4
Equipment furnishing both low-intensity and highintensity outputs provided with means minimizing
possibility of a high intensity output being selected
accidentally
52
ABNORMAL OPERATION AND FAULT CONDITIONS
Pass
52.1
Equipment is so designed and manufactured that
even in single fault condition no safety hazard as
described under 52.4 exists (see 3.1 and Cl. 13)
Pass
N/A
Not such components
provided.
N/A
N/A
Not applicable.
N/A
N/A
No such outputs.
(see appended table 52)
The safety of equipment incorporating
programmable electronic systems is checked by
applying IEC 601-1-4
N/A
N/A
52.5.2
Failure of thermostats presents no safety hazards
No thermostats
N/A
52.5.3
Short-circuiting of either part of double insulation
presents no safety hazard
Tested accordingly during the
approval of the external power
adaptor.
Pass
52.5.5
Impairment of cooling:
temperatures not exceeding 1.7 times the values
of Clause 42 minus 17.5°C
Equipment is for building in.
Compliance must be
considered in the end system.
Pass
52.5.6
Locking of moving parts presents no safety hazard No moving parts
N/A
52.5.7
Interruption and short-circuiting of motor capacitors No such components used.
presents no safety hazard
N/A
52.5.8
Duration of motors locked rotor test in compliance
with Cl. 52.5.8
No such components used.
N/A
52.5.9
Failure of one component at a time presents no
safety hazard
(see appended table 52)
Pass
52.5.10
Overload of heating elements presents no safety
hazard
No heating elements
N/A
52.5.10f
Motors intended to be remotely controlled,
automatically controlled, or liable to be operated
No motors
N/A
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SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
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continuously provided with running overload
protection
52.5.10h
Equipment with three-phase motors can safely
operate with one phase disconnected
N/A
56
COMPONENTS AND GENERAL ASSEMBLY
Pass
List of critical components
(see appended table 56.1)
Pass
Ratings of components not in conflict with the
conditions of use in equipment
All components rated
accordingly.
Pass
Ratings of mains components are identified
Considered.
Pass
56.1d
Components, movements of which could result in a Considered.
safety hazard mounted securely
Pass
56.1f
Conductors and connectors secured and/or
insulated to prevent accidental detachment
resulting in a safety hazard
Pass
56.3a
Connectors provide separation required by Subclause 17g
Pass
Plugs for connection of patient circuit leads can not No patient circuit.
be connected to other outlets on the same
equipment
N/A
Medical gas connections not interchangeable
N/A
56.1b
56.3b
Accessible metal parts can not become live when
detachable interconnection cord between different
parts of equipment is loosened or broken
56.3c
Leads with conductive connection to a patient are
constructed such that no conductive connection
remote from the patient can contact earth or
hazardous voltages.
N/A
56.4
Connections of capacitors
N/A
Not connected between live parts and nonprotectively earthed accessible parts
No such parts
No direct mains connection.
N/A
N/A
If connected between mains part and protectively
earthed metal parts comply with:
IEC Publication 384-14
N/A
Enclosure of capacitors connected to mains part
and providing only basic insulation, is not secured
to non-protectively earthed metal parts
N/A
Capacitors or other spark-suppression devices are
not connected between contacts of thermal cutouts
N/A
56.5
Protective devices which cause disconnection from No such parts
the supply mains by producing a short-circuit not
provided in equipment
N/A
56.6
Temperature and overload control devices
N/A
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Page 23 of 57
SUPERIOR PRODUCT CONSULTING, INC
56.6a
56.6b
Thermal cut-outs which have to be reset by a
soldering not fitted in equipment
Report No.:SPC 1005039
Issue Date:2010-07-20
No such parts
N/A
Thermal safety devices provided where necessary
to prevent operating temperatures exceeding the
limits
N/A
Audible warning provided where the loss of
function caused by operation of a thermal cut-out
presents a safety hazard
N/A
Self-resetting thermal cut-outs and self-resetting
over-current releases operated 200 times
N/A
Non-self resetting over-current releases operated
10 times
N/A
Independent non-self-resetting thermal cut-out
provided where a failure of a thermostat could
constitute a safety hazard
N/A
Thermostats with varying temperature settings
clearly indicated
No thermostats
N/A
Operating temperature of thermal cut-outs
indicated
No such parts
N/A
56.7
Batteries
N/A
56.7a
Battery compartments:
N/A
- adequately ventilated
N/A
- accidental short-circuiting is prevented
N/A
56.7b
Incorrect polarity of connection prevented
N/A
56.8
Indicators - unless indication provided by other means (from the normal operation
position), indicator lights are used (color see 6.7):
N/A
- to indicate that equipment is energized
N/A
No indication provided.
- to indicate the operation of non-luminous heaters No heater.
if a safety hazard could result
N/A
- to indicate when output exists if a safety hazard
could result
N/A
- charging mode indicator provided
N/A
56.10
Actuating parts of controls
56.10b
Actuating parts are adequately secured to prevent
them from working loose during normal use
N/A
Controls are secured to prevent the movement
relative to scale marking (safety related only)
N/A
Detachable indicating devices are prevented from
incorrect connection without the use of tool
N/A
Stops are provided on rotating controls:
N/A
- to prevent an unexpected change from maximum No such parts
to minimum or vice versa where this could produce
a safety hazard
N/A
56.10c
No such parts
N/A
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SUPERIOR PRODUCT CONSULTING, INC
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- to prevent damage to wiring
N/A
56.11
Cord-connected hand-held and foot-operated control devices
N/A
56.11a
Contain voltages not exceeding 25 V a.c. or 60 V
d.c. and isolated from the mains part by Cl. 17g
N/A
56.11b
Hand-held control devices comply with the
requirement and test of Sub-clause 21.5
N/A
- Foot-operated control devices designed to
support the weight of an adult human being
N/A
56.11c
Devices not change their setting when
inadvertently placed
N/A
56.11d
Foot-operated control devices are at least IPX 1
N/A
- For surgical use, electrical switching parts are IPX
8
N/A
56.11e
Adequate strain relief at the cord entry provided
N/A
57
MAINS PARTS, COMPONENTS AND LAYOUT
Pass
57.1
Isolation from supply mains
Pass
57.1a
Equipment provides means to isolate its circuits
electrically from the supply mains on all poles
simultaneously
No such parts
Equipment if for building in.
Compliance must be
considered in the end system.
Means for isolation incorporated in equipment or, if
external, specified in the accompanying documents
N/A
N/A
57.1d
Switches used to comply with Sub-clause 57.1a
comply with the creepage distances and air
clearances as specified in IEC Publication 328
57.1f
Mains switches not incorporated in a power supply
cord
N/A
57.1h
Appliance couplers and flexible cords with mains
plugs provide compliance with Sub-clause 57.1a
N/A
57.1m
Fuses and semiconductor devices not used as
isolating devices
57.2
Mains connectors and appliance inlets
N/A
57.2e
Auxiliary mains socket-outlets on non-permanently No mains socket-outlet
installed equipment of a type that cannot accept a provided.
mains plug
N/A
57.2g
Unless functional earth needs to be provided,
Class I appliance inlet is not used in Class II
equipment
N/A
57.3
Power supply cords
N/A
57.3a
Not more than one connection to a particular
supply mains
If alternative supply allowed, no safety hazards
No switch provided.
Considered.
No power supply cord
provided.
N/A
Pass
N/A
N/A
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SUPERIOR PRODUCT CONSULTING, INC
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when more than one connection is made
simultaneously
The mains plug has only one power supply cord
N/A
Non-permanently connected equipment provided
with power supply cord or appliance inlet
N/A
Power supply cords sufficiently robust to comply
with the requirements of IEC 227, designation 53
and IEC 245, designation 53
N/A
Polyvinyl chloride insulated power supply cords not
used for equipment having external metal parts
with a temperature exceeding 75°C
N/A
57.3c
Nominal cross-sectional area of conductors of
power supply cords not less than in Table XV
N/A
57.3d
Stranded conductors not soldered if fixed by any
clamping means
N/A
57.4
Connection of power supply cords
N/A
57.4a
Cord anchorages
N/A
Equipment provided with power supply cords has
cord anchorages such that the conductors are
relieved from strain, including twisting
N/A
Tying the cord into a knot or tying the ends with
string not used
N/A
Cord anchorages made of insulating material or
metal insulated from unearthed accessible metal
parts by supplementary insulation
N/A
Cord anchorages made of metal provided with an
insulating lining
N/A
Clamping screws do not bear directly on the cord
insulation
N/A
Screws associated with cable replacement are not
used to secure other components
N/A
Conductors of the power supply cord arranged that
the protective earth conductor is not subject to
strain as long as the phase conductors are in
contact with their terminals
N/A
57.3b
57.4b
Power supply cord protected against excessive
bending
No power supply cord
provided.
N/A
57.4c
Adequate space inside equipment to allow the
supply cable conductors to be introduced and
connected
N/A
57.5
Mains terminal devices and wiring of mains part
N/A
Mains connected equipment other than those with
a detachable supply cord provided with mains
terminals, where connections are made with
screws, nuts or equally effective methods
N/A
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SUPERIOR PRODUCT CONSULTING, INC
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If a conductor breaks away, barriers are provided
such that creepage distances and air clearances
cannot be reduced
N/A
Screws and nuts which clamp external conductors
not serve to fix any other component
N/A
Terminals closely grouped with any protective earth
terminal
N/A
Mains terminal devices accessible only with use of
a tool
N/A
Mains terminal devices located or shielded that,
should a wire of a stranded conductor escape
when the conductors are fitted, there is no risk of
accidental contact
N/A
57.5c
Internal wiring not subjected to stress when the
means for clamping the conductors are tightened
or loosened
N/A
57.5d
Cord terminals not require special preparation of
the conductor
N/A
57.6
Mains fuses and overcurrent releases
N/A
Fuses or over-current releases provided
accordingly for Class I and Class II
N/A
Current rating of mains fuses and over-current
releases such that they reliably carry the normal
operating current
N/A
Protective earth conductor not fused
N/A
Neutral conductor not fused for permanently
installed equipment
N/A
57.8
Wiring of the mains part
N/A
57.8a
Individual conductor in the mains part with
Equipment is for building in.
insulation not at least electrically equivalent to that Compliance must be
of the individual conductors of flexible supply cords considered in the end system.
complying with IEC Publications 227 or 245,
treated as bare conductor
N/A
57.8b
Cross-sectional area of conductors up to protective
device not less than the minimum required for the
power supply cord
N/A
Cross-sectional area of other wiring and the sizes
of tracks on printed wiring circuits sufficient to
prevent any fire hazard
N/A
57.9
Mains supply transformers
Pass
57.9.1
Overheating
Pass
External to the transformer protective devices
connected in such a way that failure of any
component cannot render the protective devices
inoperative
Pass
57.5b
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SUPERIOR PRODUCT CONSULTING, INC
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57.9.1a
Short-circuit of secondary windings not caused
excessive temperature
(see appended table 57.9.1a)
Pass
57.9.1b
Overload of secondary windings not caused
excessive temperature
(see appended table 57.9.1a)
Pass
57.9.2
The dielectric strength of the electrical insulation of (see appended table 57.9.1a)
a mains supply transformer such that it passes
tests
Pass
57.9.4
Construction
Pass
57.9.4a
Separation of primary and secondary windings
N/A
- separate bobbins or formers
N/A
- one bobbin with insulating partition
N/A
- one bobbin with concentric windings and having
copper screen with a thickness of not less than
0.13 mm
N/A
- concentrically wound on one bobbin with windings
separated by double insulation
Pass
57.9.4c
Means provided to prevent displacement of end
turns
Pass
57.9.4d
Insulated overlap of not less than 3 mm if a
protective earthed screen has only one turn
N/A
57.9.4e
Insulation between the primary and secondary in transformers with double
insulation
Pass
- 1 insulation layer having a thickness of at least 1
mm
N/A
- at least 2 insulation layers with a total thickness of
at least 0.3 mm
N/A
- three layers provided that each combination of
Approved triple insulated wire
two layers can withstand the dielectric strength test suitable for reinforced
for reinforced insulation
insulation used.
Pass
57.9.4g
Exit of the wires of toroidal transformers provided
with double sleeving complying with requirements
for double insulation and having total thickness at
least 0.3 mm extending at least 20 mm outside the
winding
N/A
57.10
Creepage distances and air clearances
Pass
57.10a
Values:
compliance with at least the values of Table XVI
(see table for insulation
diagram)
Pass
Creepage distances for slot insulation of motors at
least 50% of the specified values
No motors
N/A
57.10b
Minimum creepage distances and air clearances in
the mains part between parts of opposite polarity
not required if short-circuiting does not produce a
safety hazard
N/A
57.10c
Creepage distances or clearances of at least 4 mm No applied parts
N/A
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SUPERIOR PRODUCT CONSULTING, INC
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are maintained between defibrillation-proof applied
parts and other parts
58
PROTECTIVE EARTHING - TERMINALS AND CONNECTIONS
N/A
58.1
Clamping means of the protective earth terminal
N/A
Not be able to loosen without the aid of a tool
Equipment is for building in.
Compliance must be
considered in the end system.
N/A
Screws for internal earth connections are covered
or protected against loosening from outside
N/A
58.7
Earth pin of the appliance inlet regarded as the
protective earth terminal
N/A
58.8
The protective earth terminal not used for the
mechanical connection or the fixing of any
component not related to earthing
N/A
58.9
Where the protective earth connections are made
via a plug or socket device the protective earth
connection is made before and interrupted after the
supply connections during connection and
interrupting
N/A
59
CONSTRUCTION AND LAYOUT
N/A
59.1
Internal wiring
N/A
59.1a
Cables and wiring protected against contact with a No moving parts
moving part
N/A
Wiring having basic insulation only protected by
additional fixed sleeving
N/A
Components are not likely to be damaged in the
normal assembly or replacement of covers
N/A
59.1b
Movable leads are not bent around a radius of less No movable leads
than five times the outer diameter of the lead
N/A
59.1c
Insulating sleeving adequately secured
N/A
If the sheath of a flexible cable or cord is used as
supplementary insulation it complies with
requirements of IEC 227 and IEC 245 and
dielectric test
No such parts
N/A
Conductors subjected to temperatures exceeding
70°C have an insulation of heat-resistant material
N/A
59.1d
Aluminum wires of less than 16 mm2 cross-section
not used
N/A
59.1f
Connecting cords between equipment parts
considered as belonging to the equipment
59.2
Insulation
No such cords provided.
N/A
Pass
鼎安科技股份有限公司
Page 29 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
59.2b
Mechanical strength and resistance to heat and
fires retained by all types of insulation
N/A
59.2c
Insulation not likely to be impaired by deposition of Equipment is considered.
dirt or by dust resulting from wear of parts
Material Group IIIa and IIIb.
Pass
Parts of rubber resistant to ageing
N/A
59.3
Excessive current and voltage protection
Internal electrical power source provided with
device for protection against fire hazard
59.4
No such parts
N/A
No such parts
N/A
Fuse elements replaceable without opening the
enclosure fully enclosed in a fuseholder
N/A
Protective devices between an isolated applied part
and the body of the equipment do not operate
below 500 V r.m.s.
N/A
Oil containers
N/A
Oil containers adequately sealed
No oil containers
N/A
Container allow for the expansion of the oil
N/A
Oil containers in mobile equipment sealed to
prevent the loss of oil during transport
N/A
Partially sealed oil-filled equipment or equipment
parts provided with means for checking the oil level
N/A
鼎安科技股份有限公司
Page 30 of 57
SUPERIOR PRODUCT CONSULTING, INC
6.1
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
TABLE: marking durability
Marking tested
Remarks
Markings are rubbed by hand, without
undue pressure, first for 15 s with a cloth
rag soaked with distilled water, then for 15
s with a cloth rag soaked with methylated
spirit at ambient temperature and then for
15 s with a cloth rag soaked with
isopropyl alcohol.
Top surface of plastic enclosure
supplementary information:
7
Pass
TABLE: power input
Operating condition
Loading 3.3V dc, 606 mA
Voltage
(V)
3.3
Loading 15V dc, 133 mA
3.3
dc
715.1mA
2.36
Loading 3.3V dc, 606 mA
5
dc
531.5
2.66
Loading 15V dc, 133 mA
5
dc
478.2
2.39
Loading 3.3V dc, 606 mA
9
dc
301.3
2.71
Loading 15V dc, 133 mA
9
dc
277.7
2.50
Loading 3.3V dc, 606 mA
12
dc
215.4
2.58
Loading 15V dc, 133 mA
12
dc
194.3
2.33
Loading 3.3V dc, 606 mA
15
dc
166.4
2.50
Loading 15V dc, 133 mA
15
dc
153.0
2.30
Loading 3.3V dc, 606 mA
24
dc
108.8
2.61
Loading 15V dc, 133 mA
24
dc
98.6
2.37
supplementary information:
Frequency Current
(Hz)
(A)
dc
783.9mA
Power
(W)
2.59
Remarks
Satisfactory for Model
R3.3P23.3S/R6.4
Satisfactory for Model
R3.3P215S/R6.4
Satisfactory for Model
R05P23.3S/R6.4
Satisfactory for Model
R05P215S/R6.4
Satisfactory for Model
R09P23.3S/R6.4
Satisfactory for Model
R09P215S/R6.4
Satisfactory for Model
R12P23.3S/R6.4
Satisfactory for Model
R12P215S/R6.4
Satisfactory for Model
R15P23.3S/R6.4
Satisfactory for Model
R15P215S/R6.4
Satisfactory for Model
R24P23.3S/R6.4
Satisfactory for Model
R24P215S/R6.4
鼎安科技股份有限公司
Page 31 of 57
Report No.:SPC 1005039
SUPERIOR PRODUCT CONSULTING, INC
15b
Issue Date:2010-07-20
N/A
TABLE: residual voltage in attachment plug
Voltage measured
between:
Measurements [ V ]
1
2
3
4
5
6
Remarks
7
8
9
10
supplementary information:
15c
N/A
TABLE: residual voltage or energy in capacitors
Capacitor and its location
Residual
voltage
(V)
Time after
Capacitance
disconnection
value
(s)
(µF)
Residual
energy
(mJ)
Remarks
supplementary information:
17h1
N/A
TABLE: defibrillation-proof applied parts
Test
Condition:
Fig. 50 or 51
Accessible part of
measurement:
Applied part with test
voltage
Test
voltage
polarity
Measured
voltage
between
Y1 and Y2
(mV)
Remarks
supplementary information:
17h2
N/A
TABLE: defibrillation-proof recovery time
Applied part
with test voltage
supplementary information:
Test
voltage
polarity
Recovery time
from
accompanying
documents (s)
Measured
recovery
time (s)
Remarks
鼎安科技股份有限公司
Page 32 of 57
SUPERIOR PRODUCT CONSULTING, INC
18
Report No.:SPC 1005039
Issue Date:2010-07-20
N/A
TABLE: protective earthing
Test location
Test
Measured Resistance
current (A) voltage
(ohms)
(V)
Remarks
supplementary information:
19
Pass
TABLE: leakage current
Supply
voltage
(V)
Supply
frequency
(Hz)
Measured
max. value
(µA)
For Model R24P215S/R6.4
--
--
--
EN, NC, S1 = 1, S5 = 1, S7 = 1
EN, SFC, S1 = 0, S5 = 1, S7 = 1
24
24
DC
DC
0.01/0.01
0.01/0.01
Type of leakage current and test condition
(including single faults)
Remarks
-Pass
Pass
supplementary information:
Record at least maximum measured value for each test required by Clause 19 and the specific conditions of
the test circuit and equipment.
ER - Earth leakage current
EN - Enclosure leakage current
P - Patient leakage current
PM - Patient leakage current with mains on the applied parts
PA - Patient auxiliary current
Fig. 15 - refers to Fig. 15 in IEC601-1
MD - Measuring device
A - After humidity conditioning
B - Before humidity conditioning
1 - Switch closed or set to normal polarity
0 - Switch open or set to reversed polarity
NC - Normal condition
SFC - Single fault condition
鼎安科技股份有限公司
Page 33 of 57
SUPERIOR PRODUCT CONSULTING, INC
20
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
TABLE: dielectric strength
Insulation under test
(area from insulation
diagram)
Input Pins to Output
Pins
Insulation type: (OP-operational /
BI-basic / SI-supplementary /
DI-double / RI-reinforced)
For Unit
RI
Reference
voltage (V)
Test
voltage
(V)
Remarks
43.7
3000Vac
No breakdown
For Transformer T1
Input Pins to Output
RI
43.7
3000Vac
No breakdown
Pins
Output Pins to core
RI
43.7
3000Vac
No breakdown
(Considered to be input
side) or
Input Pins to Core
(Consider to be output
side)
One lsyer of Insulation
BI
43.7
1000Vac
No breakdown
Sheet
Two layers of Insulation
RI
43.7
3000Vac
No breakdown
Sheet
supplementary information:
1. The above tests were conducted with Models R24P215S/R6.4, R24P23.3S/R6.4, R15P215S/R6.4,
R15P23.3S/R6.4, R12P215S/R6.4, R12P23.3S/R6.4, R09P215S/R6.4, R09P23.3S/R6.4, R05P215S/R6.4,
R05P23.3S/R6.4, R3.3P215S/R6.4, R3.3P23.3S/R6.4 and RV2415S/R6.4 for Unit.
2. The above tests were conducted for all transformers.
For Unit
Input Pins to Output
RI
43.7
5000Vac
No breakdown
Pins
For Transformer T1
Input Pins to Output
RI
43.7
5000Vac
No breakdown
Pins
Output Pins to core
RI
43.7
5000Vac
No breakdown
(Considered to be input
side) or
Input Pins to Core
(Consider to be output
side)
One lsyer of Insulation
BI
43.7
2500Vac
No breakdown
Sheet
Two layers of Insulation
RI
43.7
5000Vac
No breakdown
Sheet
supplementary information:
1. The above tests were conducted with Models R24P215S/R8, R24P23.3S/R8, R15P215S/R8,
R15P23.3S/R8, R12P215S/R8, R12P23.3S/R8, R09P215S/R8, R09P23.3S/R8, R05P215S/R8,
R05P23.3S/R8, R3.3P215S/R8, R3.3P23.3S/R8 and RV2415S/R8 for Unit.
2. The above tests were conducted for all transformers.
鼎安科技股份有限公司
Page 34 of 57
SUPERIOR PRODUCT CONSULTING, INC
21
Report No.:SPC 1005039
Issue Date:2010-07-20
N
TABLE: mechanical strength
Part under test
Test (impact, drop, force, handle, rough
handling, mobile)
Remarks
supplementary information:
24
N/A
TABLE: - stability
Part under test
Test condition
Remarks
supplementary information:
29
N/A
TABLE: X - radiation
Part under test
supplementary information:
Test condition
Measured
radiation
(mR)
Remarks
鼎安科技股份有限公司
Page 35 of 57
SUPERIOR PRODUCT CONSULTING, INC
42
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
TABLE: normal temperature
Supply voltage: see below
Test Condition: see below
Ambient temperature: See below
Measuring location
Supply voltage: 3.3Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 5Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 9Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 12Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 15Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Measured temperature (°C)
Model R3.3P23.3S/R6.4 Model R3.3P215S/R6.4
(3.3Vdc, 606mA)
(15Vdc, 133mA)
107.0
98.4
107.1
99.5
107.2
99.6
102.8
94.4
103.3
93.3
107.0
93.8
102.2
93.9
85
85
Model R05P23.3S/R6.4 Model R05P215S/R6.4
(3.3Vdc, 606mA)
(15Vdc, 133mA)
108.6
112.0
109.3
114.9
1120
116.8
102.5
103.7
100.1
102.9
106.0
103.4
95.9
104.8
85
85
Model R09P23.3S/R6.4 Model R09P215S/R6.4
(3.3Vdc, 606mA)
(15Vdc, 133mA)
109.5
111.9
108.2
99.7
109.6
113.6
103.7
102.9
100.0
101.6
104.1
102.3
95.5
108.9
85
85
Model R12P23.3S/R6.4 Model R12P215S/R6.4
(3.3Vdc, 606mA)
(15Vdc, 133mA)
109.9
105.0
109.7
104.9
110.2
105.6
106.2
101.2
105.6
99.9
111.2
100.9
101.8
98.9
85
85
Model R15P23.3S/R6.4 Model R15P215S/R6.4
(3.3Vdc, 606mA)
(15Vdc, 133mA)
106.5
103.3
107.0
104.3
107.9
104.4
103.9
101.8
Remarks
Limited
130
130
130
130
130
130
--Limited
130
130
130
130
130
130
--Limited
130
130
130
130
130
130
--Limited
130
130
130
130
130
130
--Limited
130
130
130
130
鼎安科技股份有限公司
Page 36 of 57
SUPERIOR PRODUCT CONSULTING, INC
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 24Vdc
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 5Vdc
Resistor R1
Inductor L1 Coil
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Diode D1
Enclosure
Ambient
Supply voltage: 24Vdc
Resistor R1
Inductor L1 Coil
Capacitor C1
Transistor Q1
Transistor Q2
Power Transformer T1 Core
Power Transformer T1 Coil
Enclosure
Ambient
104.4
110.7
100.3
85
Model R24P23.3S/R6.4
(3.3Vdc, 606mA)
104.9
109.0
112.6
105.3
104.6
112.5
102.3
85
Model RV-053.3S/6.4
(3.3Vdc, 606mA)
100.8
98.3
99.6
103.5
101.2
97.9
96.1
101.0
91.7
85
Model RV-243.3S/6.4
(3.3Vdc, 606mA)
102.8
98.6
101.4
103.3
103.2
102.0
101.0
98.4
85
Issue Date:2010-07-20
101.5
97.8
98.1
85
Model R24P215S/R6.4
(15Vdc, 133mA)
108.2
100.6
108.8
100.9
100.2
100.0
100.6
85
--
130
130
130
130
130
130
--Limited
------------
130
130
130
130
130
130
130
130
130
-Limited
----------
130
130
130
130
130
130
130
130
--
COR - indicates measurements taken using change-of-resistance method
supplementary information:
Report No.:SPC 1005039
130
130
--Limited
鼎安科技股份有限公司
Page 37 of 57
SUPERIOR PRODUCT CONSULTING, INC
44
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
TABLE: overflow, spillage, leakage, humidity, ingress of liquids, cleaning,
sterilization, desinfection
Test type and condition
Humidity Preconditioning Treatment (clause
44.5): 95% R.H, 40°C, 120 hours
Part under test
Complete unit
Remarks
No dielectric
breakdown.
Humidity Preconditioning Treatment (clause
44.5): 95% R.H, 40°C, 120 hours
Humidity Preconditioning Treatment (clause
44.5): 95% R.H, 40°C, 120 hours
Transformer T1
No dielectric
breakdown.
No dielectric
breakdown.
Insulation Tape on T1
supplementary information:
(Model R24P215S/R$,
R24P23.3S/R$, R15P215S/R$,
R15P23.3S/R$, R12P215S/R$,
R12P23.3S/R$, R09P215S/R$,
R09P23.3S/R$, R05P215S/R$,
R05P23.3S/R$, R3.3P215S/R$,
R3.3P23.3S/R$ and RV2415S/R$)
45
TABLE: hydrostatic pressure and pressure-relief device cycling test
Test type and condition
supplementary information:
Part under test
Test
pressure
N/A
Remarks
鼎安科技股份有限公司
SUPERIOR PRODUCT CONSULTING, INC
52
Page 38 of 57
Report No.:SPC 1005039
Issue Date:2010-07-20
Pass
TABLE: abnormal operation
Test type, condition and clause reference
Observed results
Test were conducted with Model R24P215S/R6.4
C2 short, Clause 52.5.9
Input pin opened, no output, no hazards.
C1 short, Clause 52.5.9
Q1, Q2 damaged, no output, no hazard.
C4 short, Clause 52.5.9
Unit shut down at once, no output, no hazard.
Q2 (C-E) short, Clause 52.5.9
Q1, Q2 damaged, no output, no hazard.
Q2 (B-E) short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Q2 (C-E) short, Clause 52.5.9
Q2 damaged, no output, no hazard.
T1 Pins NS1-NS short, Clause 52.5.9
Unit shut down at once, no output, no hazard.
T1 Pins NS2-NS short, Clause 52.5.9
Unit shut down at once, no output, no hazard.
D1 short, Clause 52.5.9
Q1, Q2 damaged, no output, no hazard.
C3 short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
C2 short, Clause 52.5.9
L1 damaged, no output, no hazard.
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.153A, T1 coil =
98.4°C, T1 Core = 111.6°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R3.3P3.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
115.3°C, T1 Core = 122.6°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R3.3P215S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.163A, T1 coil =
115.5°C, T1 Core = 114.9°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R05P23.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
120.7°C, T1 Core = 128.1°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R05P215S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.161A, T1 coil =
125.2°C, T1 Core = 125.2°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R09P23.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
122.8°C, T1 Core = 127.7°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R09P215S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.161A, T1 coil =
124.4°C, T1 Core = 125.4°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R12P23.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
Remarks
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
鼎安科技股份有限公司
SUPERIOR PRODUCT CONSULTING, INC
Page 39 of 57
Report No.:SPC 1005039
Issue Date:2010-07-20
129.2°C, T1 Core = 119.5°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R12P215S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.174A, T1 coil =
116.0°C, T1 Core = 117.1°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R15P23.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
121.0°C, T1 Core = 126.9°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R15P215S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.177A, T1 coil =
124.4°C, T1 Core = 125.4°C, Ambient = 85°C,
no hazard.
Test were conducted with Model R24P23.3S/R6.4
Output short, Clause 52.5.9
Unit shut sown at once, no output, no hazard.
Output overload, Clause 52.5.9
Max. overload current = 0.637A, T1 coil =
120.7°C, T1 Core = 128.7°C, Ambient = 85°C,
no hazard.
supplementary information:
Pass
Pass
Pass
Pass
Pass
Pass
Pass
Pass
鼎安科技股份有限公司
Page 40 of 57
SUPERIOR PRODUCT CONSULTING, INC
56.1
TABLE: list of critical components
Object/part No.
Manufacturer/
trademark
Top Main Enclosure (for Wah Hong Industrial
all series) / Bottom Plate Corp.
(for RV series only)
Potting Material
PCB
Choke (L1)
(only for RV series)
Transistor (Q1, Q2)
Capacitor (C1)
Capacitor (C2)
Transformer (T1)
(for Models
R3.3P23.3S/R6.4,
R3.3P23.3D/R6.4,
RV-3.33.3D/R6.4)
Transformer (T1)
(for Models
R3.3P205S/R6.4,
R3.3P205D/R6.4,
RV-3.305D/R6.4,
RV-3.305D/R6.4)
Transformer (T1)
(for Models
R3.3P209S/R6.4,
R3.3P209D/R6.4,
R3.3P09S/R6.4)
Momentive
Performance
Materials Japan LLC
Various
Gang Song
Electronics Co., Ltd
Various
Various
Various
CTC Coil
Technology
Corporation
Report No.:SPC 1005039
Issue Date:2010-07-20
type/model
technical data
Standard
WH-9100
V-0, 130°C
UL746C
UL94
Required
Marks of
Conformity
UL
Overall approx. 19.0 by 9.7 by
12.5 mm, 0.45 mm thickness
for RXX series
Overall approx. 31.9 by 14.2
by 10.5 mm, 0.66 mm
thickness for RV series.
V-0, 105°C
UL746D
UL
Various
GS32-4R7M
min. V-0, min. 130°C
130°C
UL94, UL796
--
UL
--
Various
Various
Various
TFP2-3.33.3/R6.4
min. 15V, min. 0.5A
max. 0.01uF, min. 50V
max. 10uF, min. 16V
Class B
-----
-----
TSE3331(A),
TSE3331(B)
CTC Coil
Technology
Corporation
TFP2-3.305/R6.4 Class B
--
--
CTC Coil
Technology
Corporation
TFP2-3.309/R6.4 Class B
--
--
鼎安科技股份有限公司
Page 41 of 57
SUPERIOR PRODUCT CONSULTING, INC
Transformer (T1)
(for Models
R3.3P212S/R6.4,
R3.3P212D/R6.4)
Transformer (T1)
(for Models
R3.3P215S/R6.4,
R3.3P215D/R6.4)
Transformer (T1)
(for Models
R05P23.3S/R6.4,
R05P23.3D/R6.4)
Transformer (T1)
(for Models
R05P205S/R6.4,
R05P205D/R6.4,
RV-0505S/R6.4,
RV-0505D/R6.4)
Transformer (T1)
(for Models
R05P209S/R6.4,
R05P209D/R6.4,
RV-0509S/R6.4,
RV-0509D/R6.4)
Transformer (T1)
(for Models
R05P212S/R6.4,
R05P212D/R6.4,
RV-0512S/R6.4,
RV-0512D/R6.4)
Transformer (T1)
(for Models
R05P215S/R6.4,
R05P215D/R6.4,
RV-0515S/R6.4,
RV-0515D/R6.4)
Transformer (T1)
(for Models
R09P23.3S/R6.4,
RV-093.3S/R6.4,)
Report No.:SPC 1005039
Issue Date:2010-07-20
CTC Coil
Technology
Corporation
TFP2-3.312/R6.4 Class B
--
--
CTC Coil
Technology
Corporation
TFP2-3.315/R6.4 Class B
--
--
CTC Coil
Technology
Corporation
TFP2-053.3/R6.4 Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0505/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0509/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0512/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0515/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-093.3/R6.4 Class B
--
--
鼎安科技股份有限公司
Page 42 of 57
SUPERIOR PRODUCT CONSULTING, INC
Transformer (T1)
(for Models
R09P23.3S/R6.4,
R09P23.3D/R6.4,
R09P3.3D/R6.4
RV-093.3D/R6.4)
Transformer (T1)
(for Models
R09P205S/R6.4,
R09P205D/R6.4,
R09P05D/R6.4
RV-0905S/R6.4)
Transformer (T1)
(for Models
R09P209S/R6.4,
R09P209D/R6.4,
R09P09D/R6.4
RV-09PS/R6.4)
Transformer (T1)
(for Models
R09P212S/R6.4,
R09P212D/R6.4,
R09P12D/R6.4
R09P12D/R6.4
RV-09P12S/R6.4,
RV-09P12D/R6.4)
Transformer (T1)
(for Models
R09P215S/R6.4,
R09P215D/R6.4,
RV-09P15S/R6.4,
RV-09P15D/R6.4)
Transformer (T1)
(for Models
R12P23.3S/R6.4,
RV-123.3S/R6.4)
Transformer (T1)
(for Models
R12P23.3D/R6.4,
R12P3.3S/R6.4,
Report No.:SPC 1005039
Issue Date:2010-07-20
CTC Coil
Technology
Corporation
TFP2093.3D/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0905/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0909/R6.4
Class B
--
--
CTC Coil
Technology
Corporation
TFP2-0912/R6.4
Class B
--
--
CTC Coil Technology TFP2-0915/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-123.3/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2Corporation
123.3D/R6.4
Class B
--
--
鼎安科技股份有限公司
Page 43 of 57
SUPERIOR PRODUCT CONSULTING, INC
R12P3.3D/R6.4,
RV-123.3D/R6.4)
Transformer (T1)
(for Models
R12P205S/R6.4,
R12P205D/R6.4,
R12P05D/R6.4,
R12P05S/R6.4,
RV-1205S/R6.4,
RV-1205D/R6.4)
Transformer (T1)
(for Models
R12P209S/R6.4,
R12P209D/R6.4,
R12P09D/R6.4,
R12P09S/R6.4,
RV-1209S/R6.4,
RV-1209D/R6.4)
Transformer (T1)
(for Models
R12P212S/R6.4,
R12P212D/R6.4,
R12P12D/R6.4,
R12P12S/R6.4,
RV-1212S/R6.4,
RV-1212D/R6.4)
Transformer (T1)
(for Models
R12P215S/R6.4,
R12P215D/R6.4,
R12P15D/R6.4,
R12P15S/R6.4,
RV-1215S/R6.4,
RV-1215D/R6.4)
Transformer (T1)
(for Models
R15P23.3S/R6.4,
R15P23.3D/R6.4)
Transformer (T1)
(for Models
Report No.:SPC 1005039
Issue Date:2010-07-20
CTC Coil Technology TFP2-1205/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1209/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1212/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1215/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-153.3/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1505/R6.4
Corporation
Class B
--
--
鼎安科技股份有限公司
Page 44 of 57
SUPERIOR PRODUCT CONSULTING, INC
R15P205S/R6.4,
R15P205D/R6.4,
R15P05D/R6.4,
R15P05S/R6.4,
RV-1505S/R6.4,
RV-1505D/R6.4)
Transformer (T1)
(for Models
R15P209S/R6.4,
R15P209D/R6.4,
R15P09D/R6.4,
R15P09S/R6.4,
RV-1509S/R6.4,
RV-1509D/R6.4)
Transformer (T1)
(for Models
R15P212S/R6.4,
R15P212D/R6.4,
R15P12D/R6.4,
R15P12S/R6.4,
RV-1512S/R6.4,
RV-1512D/R6.4)
Transformer (T1)
(for Models
R15P215S/R6.4,
R15P215D/R6.4,
R15P15D/R6.4,
R15P15S/R6.4,
RV-1515S/R6.4,
RV-1515D/R6.4)
Transformer (T1)
(for Models
Report No.:SPC 1005039
Issue Date:2010-07-20
CTC Coil Technology TFP2-1509/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1512/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-1515/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-243.3/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2Corporation
243.3D/R6.4
Class B
--
--
R24P23.3S/R6.4,
RV-243.3D/R6.4)
Transformer (T1)
(for Models
R24P23.3D/R6.4,
R24P3.3S/R6.4,
R24P3.3D/R6.4)
鼎安科技股份有限公司
Page 45 of 57
SUPERIOR PRODUCT CONSULTING, INC
Transformer (T1)
(for Models
CTC Coil Technology TFP2-2405/R6.4
Corporation
Report No.:SPC 1005039
Issue Date:2010-07-20
Class B
--
--
CTC Coil Technology TFP2-2405D/R6.4 Class B
Corporation
--
--
CTC Coil Technology TFP2-2409/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-2412/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-2415/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-3.33.3/R6.4 Class B
Corporation
--
--
CTC Coil Technology TFP2Corporation
3.33.3D/R6.4
--
--
R24P205S/R6.4,
R24P05S/R6.4,
RV-2405S/R6.4,
RV-2405D/R6.4,)
Transformer (T1)
(for Models
R24P205D/R6.4,
R24P05D/R6.4,)
Transformer (T1)
(for Models
R24P209S/R6.4,
R24P209D/R6.4,
R24P09S/R6.4,
R24P09D/R6.4,
RV-2409S/R6.4,
RV-2409D/R6.4,)
Transformer (T1)
(for Models
R24P212S/R6.4,
R24P212D/R6.4,
R24P12S/R6.4,
R24P12D/R6.4,
RV-2412S/R6.4
RV-2412D/R6.4)
Transformer (T1)
(for Models
R24P215S/R6.4,
R24P215D/R6.4,
R24P15S/R6.4,
R24P15D/R6.4)
Transformer (T1)
(for Models
R3.3P3.3S/R6.4)
Transformer (T1)
(for Models
Class B
鼎安科技股份有限公司
Page 46 of 57
SUPERIOR PRODUCT CONSULTING, INC
Report No.:SPC 1005039
Issue Date:2010-07-20
R3.3P3.3D/R6.4)
Transformer (T1)
(for Models
CTC Coil Technology TFP2-3.305/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2Corporation
3.305D/R6.4
Class B
--
--
CTC Coil Technology TFP2-3.309/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-3.312/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-3.315/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-053.3/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-0505/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-0509/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-0512/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-0515/R6.4
Corporation
Class B
--
--
R3.3P05S/R6.4)
Transformer (T1)
(for Models
R3.3P05D/R6.4)
Transformer (T1)
(for Models
R3.3P09D/R6.4)
Transformer (T1)
(for Models
R3.3P12S/R6.4,
R3.3P12D/R6.4,)
Transformer (T1)
(for Models
R3.3P15S/R6.4,
R3.3P15D/R6.4,)
Transformer (T1)
(for Models
R05P3.3S/R6.4,
R05P3.3D/R6.4,)
Transformer (T1)
(for Models
R05P05S/R6.4,
R05P05D/R6.4,)
Transformer (T1)
(for Models
R05P09S/R6.4,
R05P09D/R6.4)
Transformer (T1)
(for Models
R05P12S/R6.4,
R05P12D/R6.4,)
Transformer (T1)
(for Models
R05P15S/R6.4,
R05P15D/R6.4,)
鼎安科技股份有限公司
Page 47 of 57
SUPERIOR PRODUCT CONSULTING, INC
Transformer (T1)
(for Models
Report No.:SPC 1005039
Issue Date:2010-07-20
CTC Coil Technology TFP2-0915/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2-153.3/R6.4
Corporation
Class B
--
--
CTC Coil Technology TFP2Corporation
3.33.3S/R6.4
Class B
--
--
CTC Coil Technology TFP2Corporation
3.309S/R6.4
Class B
--
--
CTC Coil Technology TFP2Corporation
3.312S/R6.4
Class B
--
--
CTC Coil Technology TFP2Corporation
3.315S/R6.4
Class B
--
--
CTC Coil Technology TFP2Corporation
3.315D/R6.4
Class B
--
--
CTC Coil Technology TFP2Corporation
053.3S/R6.4
Class B
--
--
CTC Coil Technology TFP2-0905S/R6.4 Class B
Corporation
--
--
CTC Coil Technology TFP2-0909S/R6.4 Class B
Corporation
--
--
CTC Coil Technology TFP2-
--
--
R09P15S/R6.4,
R09P15D/R6.4,)
Transformer (T1)
(for Models
R15P3.3S/R6.4,
R15P3.3D/R6.4,)
Transformer (T1)
(for Models
RV-3.33.3S/R6.4)
Transformer (T1)
(for Models
RV-3.309S/R6.4,
RV-3.309D/R6.4)
Transformer (T1)
(for Models
RV-3.312S/R6.4,
RV-3.312D/R6.4)
Transformer (T1)
(for Models
RV-3.315S/R6.4)
Transformer (T1)
(for Models
RV-3.315D/R6.4)
Transformer (T1)
(for Models
RV-053.3S/R6.4,
RV-053.3D/R6.4)
Transformer (T1)
(for Models
RV-0905S/R6.4,
RV-0905D/R6.4)
Transformer (T1)
(for Models
RV-0909S/R6.4,
RV-0909D/R6.4)
Transformer (T1)
Class B
鼎安科技股份有限公司
Page 48 of 57
SUPERIOR PRODUCT CONSULTING, INC
(for Models
Corporation
Report No.:SPC 1005039
Issue Date:2010-07-20
153.3S/R6.4
RV-153.3S/R6.4,
RV-153.3D/R6.4)
Transformer (T1)
(for Models
CTC Coil Technology TFP2Corporation
243.3S/R6.4
Class B
--
--
CTC Coil Technology TFP2-2415S/R6.4 Class B
Corporation
--
--
Furukawa Electric
Co., Ltd
UL2353,
IEC60950-1
UL, VDE
RV-243.3S/R6.4)
Transformer (T1)
(for Models
RV-2415S/R6.4,
RV-2415D/R6.4)
Triple Insulation Wire
used in T1
TEX-E
Class B
鼎安科技股份有限公司
Page 49 of 57
SUPERIOR PRODUCT CONSULTING, INC
56.10
Report No.:SPC 1005039
Issue Date:2010-07-20
N/A
TABLE: actuating parts and controls
Part under test
Torque applied
Remarks
supplementary information:
56.11b
N/A
TABLE: foot operated control devices-loading
Part under test
Observed results
Remarks
supplementary information:
57.4
N/A
TABLE: cord anchorages
Cord under test
Mass of
equipment
Pull
Torque
Remarks
supplementary information:
57.4b
N/A
TABLE: cord bending
Cord under test
Test mass
Measured
curvature
Remarks
supplementary information:
57.9.1a
TABLE: transformer short circuit
Winding
under test
Protection
Measured temperatures (°C)
Primary Secondary Ambient
-----Supplementary information: Refer to Appended Table 52.
Pass
Test
duration
--
Remarks
--
鼎安科技股份有限公司
Page 50 of 57
SUPERIOR PRODUCT CONSULTING, INC
Issue Date:2010-07-20
57.9.1b
TABLE: overload
Winding
under test
Protection
Primary
Secondary
Ambient
Test
duration
-
-
-
-
-
-
Report No.:SPC 1005039
Pass
Measured temperatures (°C)
Test current
or thermal
cutout temp.
-
Remarks
supplementary information:
Refer to Appended Table 52.
57.9.2
N/A
TABLE: transformer dielectric strength
Transformer under test
Test voltage
applied to
Test voltage
Test
frequency
Remarks
supplementary information:
59.2
part/material
TABLE: ball pressure tests
Temperature rise of this part from TABLE
42 (°C)
supplementary information:
Test temperature
(°C)
N/A
Impression diameter
(mm)
鼎安科技股份有限公司
Page 51 of 57
SUPERIOR PRODUCT CONSULTING, INC
Enclosure
Photographs
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 52 of 57
SUPERIOR PRODUCT CONSULTING, INC
Photographs
Overall view (For RXX series)
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 53 of 57
SUPERIOR PRODUCT CONSULTING, INC
Internal view (for RXX series)
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 54 of 57
SUPERIOR PRODUCT CONSULTING, INC
Overall view (for RV series)
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 55 of 57
SUPERIOR PRODUCT CONSULTING, INC
Internal view (for RV series)
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
Page 56 of 57
SUPERIOR PRODUCT CONSULTING, INC
Enclosure
Label
Report No.:SPC 1005039
Issue Date:2010-07-20
鼎安科技股份有限公司
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SUPERIOR PRODUCT CONSULTING, INC
Label for RXX series
Label for RV series
Report No.:SPC 1005039
Issue Date:2010-07-20