鼎安科技股份有限公司 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 鼎安科技股份有限公司 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. 鼎安科技股份有限公司 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. 鼎安科技股份有限公司 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 鼎安科技股份有限公司 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. 鼎安科技股份有限公司 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 鼎安科技股份有限公司 Page 10 of 57 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 鼎安科技股份有限公司 Page 11 of 57 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 鼎安科技股份有限公司 Page 12 of 57 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 鼎安科技股份有限公司 Page 13 of 57 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 鼎安科技股份有限公司 Page 14 of 57 SUPERIOR PRODUCT CONSULTING, INC 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 鼎安科技股份有限公司 Page 15 of 57 SUPERIOR PRODUCT CONSULTING, INC - 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 Page 16 of 57 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 鼎安科技股份有限公司 Page 17 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 19 of 57 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 鼎安科技股份有限公司 Page 20 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 21 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 22 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 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 鼎安科技股份有限公司 Page 24 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 - 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 鼎安科技股份有限公司 Page 25 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 26 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 27 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 鼎安科技股份有限公司 Page 28 of 57 SUPERIOR PRODUCT CONSULTING, INC Report No.:SPC 1005039 Issue Date:2010-07-20 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 Page 57 of 57 SUPERIOR PRODUCT CONSULTING, INC Label for RXX series Label for RV series Report No.:SPC 1005039 Issue Date:2010-07-20