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CB TEST Ref. Certificate No. CERTIFICATE SG-2499M2 IEC SYSTEM FOR MUTUAL RECOGNITION OF TEST CERTIFICATES FOR ELECTRICAL EQUIPMENT (IECEE) CB SCHEME Issued by: TÜV SÜD PSB Pte Ltd Product: LCD Monitor Applicant: DIVA Laboratories Ltd. 7TH FL-8, 351 CHUNG Taiwan SHAN RD, SEC 2, CHUNG HO, TAIPEI HSIEN 235 TAIWAN...
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IEC SYSTEM FOR CONFORMITY Ref. Certificate No. TESTING TO STANDARDS FOR SAFETY OF ELECTRICAL SG-2499M2 EQUIPMENT (IECEE) CB SCHEME LUXON Systems Corporation No. 161, Hsing Jen Road, Tamshui Taipei Hsien, Taiwan Additional information (if necessary) This CB Test Certificate is issued by the National Certification Body: TÜV SÜD PSB Pte Ltd 1 Science Park Drive, Singapore 118221 Signed by:...
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page 2 of 27 Report No. 55S072147/NCH/CZ Copy of marking plate: See Appendix 14 to 19 of Test Report Ref. No.: 55S061674/NCH/CZ, Appendix 5 of Test Report Ref. No.: 55S062158/NCH/CZ and Appendix 5 of this Test Report. TRF No. I6011__C TRF originator: UL...
page 3 of 27 Report No. 55S072147/NCH/CZ GENERAL INFORMATION Test item particulars (see also clause 5): Classification of installation and use ........: Portable Supply connection ..............: Appliance coupler Accessories and detachables parts included in the evaluation None ....................: Options included ..............
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= A-Z for different TFT panel supplier. Remark 4: Components used for each model are as below: Remark 5: All tests were conducted on Model: ER-191 unless otherwise specified and is the representative of the other models. TRF No. I6011__C...
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B applied part concerning protection against electric shock. IPX2, only for model: ER-191. Classification according to the degree of protection (see separate test report) against ingress of water as detailed in the current edition of IEC 529 (see 6.1.1) ........:: Not applicable.
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Name and/or trademark of the manufacturer or DIVA supplier ..............: f) Model or type reference ........: GODx7yzMI, GOKx7yzMI. ER-191 (see Remark 4 on page 4) g) Rated supply voltages or voltage range(s) 100-240 V~ Number of phases ............ : Single phase.
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page 7 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - non-ionizing radiation, or symbols as adopted by ISO or IEC 417 r) Anaesthetic-proof symbol: AP or APG ....: Not of category AP or APG. s) Dangerous voltage symbol No accessible high voltage terminal devices.
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page 8 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - Markings comply with IEC 445 See below. k) For permanently connected devices the supply Not permanently connected connections are clearly marked adjacent to the equipment.
page 9 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - Compliance with IEC 227 and IEC 245 f) Additional protective earthing in multi-conductor, Multi-conductor cord not used. cords are marked green/yellow at the ends of the additional conductors Medical gas cylinders and connections a) In accordance with ISO ISO/R 32...
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page 10 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - the replacement of material which is consumed No replacement material. during operation - information regarding potential electromagnetic or Provided in the user manual.
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page 11 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - Instructions for replacement of interchangeable No such device. and/or detachable parts which are subject to deterioration during normal use c) Instructions or reference information for repair No user repairable parts.
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page 12 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION Accessible parts of Class I equipment separated from live parts by basic insulation connected to the protective earth terminal Protective earth terminals suitable for connection Appliance inlet used.
page 13 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS 19.1b Leakage currents (see appended table 19) - earth leakage current - enclosure leakage current - patient leakage current No patient leakage current.
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Equipment or its parts with a mass of more than 20 kg is provided with: - suitable handling devices (grips etc.), or The weight of the equipment, ER-191 is 8.2 kg. (< 20 kg) - instructions for lifting and handling during assembly 24.6b...
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30ºC, 168 hours, 93% RH. effects of humidity (See appended table) 44.6 Enclosures designed to give a protection against IPX2, only for model: ER-191. harmful ingress of water classified according to (see separate test report) IEC Publication 529 44.7 Equipment capable of withstanding cleaning,...
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page 16 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict ABNORMAL OPERATION AND FAULT CONDITIONS 52.1 Equipment is so designed and manufactured that (see appended table 52) even in single fault condition no safety hazard as described under 52.4 exists (see 3.1 and Cl.
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page 17 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict COMPONENTS AND GENERAL ASSEMBLY List of critical components (see appended table 56.1) 56.1b Ratings of components not in conflict with the The components are used conditions of use in equipment according to their rating.
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page 18 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict a) Thermal cut-outs which have to be reset by a No thermal cut-out inside the soldering not fitted in equipment equipment.
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page 19 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict Detachable indicating devices are prevented from incorrect connection without the use of tool 56.10c Stops are provided on rotating controls: - to prevent an unexpected change from No such device.
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Humidity Humidity (µA) (µA) Model: ER-191, with D/A inverter: TDK, P/N: TBD319LF-2, LCD panel: NEC, P/N: NL128102BC29 Figure 16, Earth Leakage ER, NC, S1 = 1, S5 = N ER, NC, S1 = 1, S5 = R ER, SFC, S1 = 0, S5 = N...
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page 21 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict TABLE: dielectric strength Insulation under test Insulation type: (OP-operational / Reference Test Remarks (area from insulation BI-basic / SI-supplementary / voltage (V) voltage diagram)
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Test Condition: Normal load Ambient temperature . : 24.6 ºC, 24.4ºC Measured temperature Measuring location [ºC] Remarks (Limit) Model: ER-191, with D/A inverter: TDK, P/N: TBD319LF-2, LCD panel: NEC, P/N: NL128102BC29, Panel placed vertically Test Voltage 264V Measured Corrected Measured Corrected value at...
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Verdict TABLE: abnormal operation Test type, condition and clause reference Observed results Remarks Model: ER-191, with D/A inverter: TDK, P/N: TBD319LF-2, LCD panel: NEC, P/N: NL128102BC29, Panel placed vertically Ventilation openings blocked Unit operated normally. No hazard. Temperature data on: T1 coil: 72.2 ºC...
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(Harmonized better, 1.6 mm with IEC 60707 thick min. & IEC 60695-11- Enclosure Various Various Metal, (for model: min. 0.81mm ER-191) thick AC Inlet Zhang Jia Gang HF-301 250Vac, 10A UL 498 UL, VDE Hua Feng VDE 0625 EN 60320...
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page 25 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict Object/part No Manufacturer/ Type/model Technical data Standard Mark(s) of trademark conformity Switching Power DIVA DMP8012 I/P: 100-240Vac, IEC 60601-1: UL, TUV/R (CB Supply 50/60Hz, 1.4-...
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page 26 of 27 Report No. 55S072147/NCH/CZ Object/part No Manufacturer/ Type/model Technical data Standard Mark(s) of trademark conformity D/A Inverter (see TBD319LF-1, I/P: 12.6Vdc Remark 4 on TBD319LF-2 max., 3.3A max. page 4) (two models are O/P: 2000Vrms identical to each max., 7.5mA other except for max.
page 27 of 27 Report No. 55S072147/NCH/CZ SUMMARY OF CONTENTS: The equipment has been tested according to standard IEC 60601-1:1988 Second Edition + A1:1991 + A2:1995. All applicable tests according to the above specified standard(s) have been carried out. These tests fulfill the requirements of standard EN45001. This test report comprises 27 pages of CB Test Report and the following Attachments: Attachment # Description...
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Page A1 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 1 External front view of LCD Monitor Model: ER-191 55S072147...
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Page A2 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 2 External rear view of LCD Monitor Model: ER-191 55S072147...
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Page A3 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 3 Internal views of LCD Monitor Model: ER-191 55S072147 55S072147...
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Page A4 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 4 PWB views of D/A inverter (TDK, P/N: TBD319LF-2) used in LCD Monitor Model: ER-191 55S072147 55S072147...
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Page A5 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 5 Product Markings of LCD Monitor Model: ER-191 55S072147...
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Page A6 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 6 Letter of Declaration by “DIVA Laboratories Ltd.” ----1 page as attached----...
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Declaration Letter Letter Date: 2007/10/17 We, DIVA Laboratories Ltd., have to explain and confirm to our models ER-191. ER-191 same as GODx7yzMI, GOKx7yzMI ( x can be A~Z.) just enclosure different and add IPX2 for this enclosure. Best Regards Signature: John Liu Director / R&D Dept...
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