CB TEST CERTIFICATE Ref. Certificate No. SG-2634M1 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 SHAN RD, SEC 2, CHUNG HO, TAIPEI HSIEN 235 TAIWAN DIVA Laboratories 7TH FL-8, 351 CHUNG Ltd. SHAN RD, SEC 2, CHUNG HO, TAIPEI HSIEN 235 TAIWAN DIVA Laboratories Ltd.
IEC SYSTEM FOR CONFORMITY TESTING TO STANDARDS FOR SAFETY OF ELECTRICAL EQUIPMENT (IECEE) CB SCHEME Ref. Certificate No. SG-2634M1 LUXON Systems Corporation NO.
CB TEST CERTIFICATE Ref. Certificate No. SG-2634M1/B1 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 SHAN RD, SEC 2, CHUNG HO, TAIPEI HSIEN 235 TAIWAN DIVA Laboratories 7TH FL-8, 351 CHUNG Ltd. SHAN RD, SEC 2, CHUNG HO, TAIPEI HSIEN 235 TAIWAN DIVA Laboratories Ltd.
IEC SYSTEM FOR CONFORMITY TESTING TO STANDARDS FOR SAFETY OF ELECTRICAL EQUIPMENT (IECEE) CB SCHEME Ref. Certificate No. SG-2634M1/B1 LUXON Systems Corporation NO.
page 2 of 25 Report No. 55S072148/NCH/CZ Copy of marking plate See Appendix 11 to 12 of Test Report Ref. No.: 55S062732/NCH/CZ and Appendix 5 of this Test Report. TRF No.
page 3 of 25 Report No. 55S072148/NCH/CZ GENERAL INFORMATION Test item particulars (see also clause 5): Classification of installation and use ....................................... : Portable Supply connection ................................................................... : Output of external certified power adapter Accessories and detachables parts included in the evaluation .................................................................................................
page 4 of 25 Report No. 55S072148/NCH/CZ General product information and considerations: Remark 1: This modify report is to supplement the earlier Test Report No. 55S062732/NCH/CZ, dated 11 November, 2006 (CB Ref. Certificate No.: SG-2634). Remark 2: The modifications made on this report were as below: 1. Add model: ER-192. 2. Add Trademark: AG neovo (for model: ER-192) 3. Add alternate metal enclosure and base. 4.
page 5 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 5 CLASSIFICATION P 5.1 TYPE OF PROTECTION AGAINST ELECTRIC SHOCK P Class I equipment Class I equipment for external certified power adapter. P Class II equipment Class I equipment. N Internally powered equipment Class I equipment. N 5.2 Result - Remark Verdict Degree of protection against electric shock Type B applied part P No applied part.
page 6 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict 6 IDENTIFICATION, MARKING AND DOCUMENTS P 6.1 Marking on the outside of equipment or equipment parts No applicable. No specific c) Markings of the specific power supply affixed power supply affixed.
page 7 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Verdict r) Anaesthetic-proof symbol: AP or APG .................: Not of category AP or APG. N s) Dangerous voltage symbol No accessible high voltage terminal devices. N t) Special cooling requirements No such devices. N u) Limited mechanical stability The equipment did no overbalance. P v) Protective packing requirement(s) No special measure was taken during transportation or storage.
page 8 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause 6.3 Requirement + Test Result - Remark Verdict Not permanently connected k) For permanently connected devices the supply equipment. connections are clearly marked adjacent to the terminals (or in accompanying documents for small equipment) N l) Statement for suitable wiring materials at temperatures over 75 °C Not permanently connected equipment.
page 9 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict a) In accordance with ISO ISO/R 32 No such device.
page 10 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict - include: indications of recognized accessories, detachable parts and materials, if the use of other parts or materials can degrade minimum safety - instructions concerning cleaning, preventive inspection and maintenance to be performed including the frequency of such maintenance N Provided in the user manual. General information provided in instructions: 6.8.3 TRF No.
page 11 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict d) Environmental conditions for transport and storage specified in accompanying documents and marked on packaging Ambient: -20 C to +60 C o o P Humidity: 10% to 90% Air Pressure: 187 to 1060hPa was provided in the user manual.
page 12 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS P 19.1b Leakage currents P 20 Result - Remark Verdict (see appended table 19) - earth leakage current P - enclosure leakage current P - patient leakage current No patient leakage current. N - patient auxiliary current No patient auxiliary current.
page 13 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 24 STABILITY IN NORMAL USE (see appended table 24) P 24.1 Equipment does not overbalance during normal use when tilted through an angle of 10º P 24.
page 14 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict 44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, CLEANING, STERILIZATION AND DISINFECTION P 44.2 Equipment contain a liquid reservoir: N - the equipment is electrically safe after 15% overfill No liquid reservoir inside the steadily over a period of 1 min equipment.
page 15 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict 52 ABNORMAL OPERATION AND FAULT CONDITIONS P 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) P (see appended table 52) The safety of equipment incorporating programmable electronic systems is checked by applying IEC 601-1-4 N 52.5.
page 16 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 56 COMPONENTS AND GENERAL ASSEMBLY 56.1b Result - Remark Verdict P List of critical components (see appended table 56.1) P Ratings of components not in conflict with the conditions of use in equipment The components are used according to their rating. P Ratings of mains components are identified The critical components were used within the intended rating. P 56.
page 17 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Result - Remark Verdict a) Thermal cut-outs which have to be reset by a soldering not fitted in equipment No thermal cut-out inside the equipment. Thermal safety devices provided where necessary No thermal safety devices to prevent operating temperatures exceeding the inside the equipment.
page 18 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause 56.10c Requirement + Test TRF No. I6011__C Verdict Detachable indicating devices are prevented from incorrect connection without the use of tool N Stops are provided on rotating controls: N - to prevent an unexpected change from maximum to minimum or vice versa where this could produce a safety hazard 56.11 Result - Remark No such device.
page 19 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 19 TABLE: leakage current Type of leakage current and test condition (including single faults) Result - Remark Verdict P Supply voltage (V) Supply frequency (Hz) Measured max.
page 20 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am.
page 21 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 42 TABLE: normal temperature Supply voltage . : 90V, 264V Ambient temperature . 24.7 ºC. Result - Remark Verdict P Test Condition: Normal load : 25.
page 22 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 52 TABLE: abnormal operation Test type, condition and clause reference Result - Remark Verdict P Observed results Remarks Model: ER-192, 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 (Adapter): 79.1 ºC T1 core (Adapter): 74.9 ºC T1 coil (Inverter): 79.
page 23 of 25 Report No. 55S072148/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 56.1 TABLE: lists of critical component parts Object/part No Manufacturer/ trademark Result - Remark Type/model Verdict P Technical data Standard Mark(s) of 1 conformity ) Enclosure Material (for models: GOD971xMII, GOK971xMII) Bayer FR2000 Rated V-0, 1.5 mm thick min.
page 24 of 25 Object/part No Manufacturer/ trademark Type/model Report No. 55S072148/NCH/CZ Technical data Standard - Mark(s) of 1 conformity ) -Inverter TDK Transformer (T1T6) NIA15/20EMT68H002 130°C - Power Adapter Medi-Power AD-2480MB IEC 60601-1: Input: 100-240 1988+A1+A2 Vac, 60/50Hz, 1A-0.5A, Class I Output: 24Vdc, 3.33A, 80W max. TUV/R (CB Ref. Certificate No.:DE 2006195) -Alternate Use- Lien LE-0312B130W Input: 100-240 Vac, 50/60Hz, 1.7A, Class I Output: 24Vdc, 5.4A, 130W max.
page 25 of 25 Report No. 55S072148/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.
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Page A6 of A6 Ref. No.: 55S072148/NCH/CZ Appendix 6 Letter of Declaration by “DIVA Laboratories Ltd.
FACSIMILE FORM 鈺緯科技開發股份有限公司 DIVA Laboratories Ltd. 7F-8 , NO,351 , SEC.2 , CHUNG SHAN RD., CHUNG HO ,TAIPEI HSIEN , TAIWAN , R.O.C. TEL : 886-2-22268631 FAX : 886-2-22262423 Declaration Letter Letter Date: 2007/10/17 We, DIVA Laboratories Ltd., have to explain and confirm to our models ER-192. 1. ER-192 same as GOD971xMII and GOK971xMII ( x can be A~Z.) just enclosure different and add IPX2 for this enclosure.
