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CB TEST

CERTIFICATE

Ref. Certificate No.

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

SHAN RD, SEC 2,

CHUNG HO, TAIPEI

HSIEN 235 TAIWAN

Taiwan

Manufacturer:

DIVA Laboratories

Ltd.

7TH FL-8, 351 CHUNG

SHAN RD, SEC 2,

CHUNG HO, TAIPEI

HSIEN 235 TAIWAN

Taiwan

Factory:

nb: Additional factory

information on page 2

DIVA Laboratories Ltd.

7TH FL-8, 351 CHUNG

SHAN RD, SEC 2,

CHUNG HO, TAIPEI

HSIEN 235 TAIWAN

Taiwan

Rating and principal

characteristics:

100-240V~, 50/60Hz, 1.2-0.6A, Class I

Trade mark (if any):

DIVA

Model/Type

reference:

GODx7yzMI and GOKx7yzMI (where x = 8 or 9, y = 0-9 or A-Z and z = A-Z)

Additional information:

Certificate SG-2499 issued 2006-08-07 and Certificate SG-2499M1 issued

2006-10-25 are replaced by this version due to add model, trademark,

alternate metal enclosure and base and alternate classification according to

the degree of protection against ingress of water.

Sample of product

tested to be in

conformity with IEC:

60601-1(ed.2);am1;am2

Test Report Ref. No:

55S072147/NCH/CZ

This CB Test Certificate is issued by the National Certification Body:

TÜV SÜD PSB Pte Ltd

1 Science Park Drive, Singapore 118221

Signed by: Teo Kim Hock

Date of issue: 2007-11-26

Summary of content (36 pages)

PAGE 1
CB TEST CERTIFICATE Ref. Certificate No. 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 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.
PAGE 2
IEC SYSTEM FOR CONFORMITY TESTING TO STANDARDS FOR SAFETY OF ELECTRICAL EQUIPMENT (IECEE) CB SCHEME Ref. Certificate No. SG-2499M2 LUXON Systems Corporation No.
PAGE 3
PAGE 4
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.
PAGE 5
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 .....................
PAGE 6
page 4 of 27 Report No. 55S072147/NCH/CZ General product information and considerations: Remark 1: This modify report is to supplement the earlier reports: - Test Report No. 55S061674/NCH/CZ, dated 31 July 2006 (CB Ref. Certificate No.: SG-2499). - Test Report No. 55S062158/NCH/CZ, dated 19 October 2006 (CB Ref. Certificate No.: SG-2499M1) Remark 2: The modifications made on this report were as below: 1. Add model: ER-191. 2. Add Trademark: AG neovo (for model: ER-191) 3.
PAGE 7
page 5 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 5 CLASSIFICATION P 5.1 Type of protection against electric shock P 5.2 5.4 5.5 5.6 Class I equipment. P Class II equipment Class I equipment. N Internally powered equipment Class I equipment. N Degree of protection against electric shock N No applied part.
PAGE 8
page 6 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 6 Identification, marking and documents P 6.1 Marking on the outside of equipment or equipment parts P c) Markings of the specific power supply affixed Result - Remark Verdict No applicable. No specific power supply affixed. d) If marking is not practicable due to size or nature Not applicable.
PAGE 9
page 7 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Verdict - non-ionizing radiation, or symbols as adopted by ISO or IEC 417 N 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.
PAGE 10
page 8 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause 6.3 Requirement + Test Result - Remark - Markings comply with IEC 445 See below. Verdict P 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 11
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, cords are marked green/yellow at the ends of the additional conductors 6.6 N Multi-conductor cord not used. Medical gas cylinders and connections a) In accordance with ISO ISO/R 32 N N No such device.
PAGE 12
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 during operation No replacement material. - information regarding potential electromagnetic or Provided in the user manual.
PAGE 13
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 and/or detachable parts which are subject to deterioration during normal use No such device. N c) Instructions or reference information for repair of equipment parts designated by the manufacturer as repairable provided No user repairable parts.
PAGE 14
page 12 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL EQUALIZATION P 18a Accessible parts of Class I equipment separated from live parts by basic insulation connected to the protective earth terminal P 18b Protective earth terminals suitable for connection to the protective earth conductor 18e Potential equalization conductor - Readily accessible 18f Result - Remark Verdict Appliance inlet used.
PAGE 15
page 13 of 27 Report No. 55S072147/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 16
page 14 of 27 Report No. 55S072147/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.
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page 15 of 27 Report No. 55S072147/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 18
page 16 of 27 Report No. 55S072147/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 19
page 17 of 27 Report No. 55S072147/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 20
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 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 21
page 19 of 27 Report No. 55S072147/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 22
page 20 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 18 TABLE: protective earthing Result - Remark Verdict P Test current (A) Test location AC inlet Earth Pin to Enclosure Measured Resistance (ohms) voltage (V) 40 0.4 10 m Remarks 2 min Supplementary information: 19 TABLE: leakage current Type of leakage current and test condition (including single faults) P Supply voltage (V) Supply frequency (Hz) Measured max.
PAGE 23
page 21 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am.
PAGE 24
page 22 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test 42 TABLE: normal temperature Supply voltage . : 90V, 264V Ambient temperature . 24.4ºC Result - Remark Verdict P Test Condition: Normal load : 24.
PAGE 25
page 23 of 27 Report No. 55S072147/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-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 T1 core: 74.9 ºC Ambient: 26.2 ºC Supplementary information: TRF No.
PAGE 26
page 24 of 27 Report No. 55S072147/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 (for models GODx7yzMI, GOKx7yzMI) Bayer FR2000 Rated V-1 or better, 1.6 mm thick min. UL 746 UL (Harmonized with IEC 60707 & IEC 60695-1110) -Alternate Use- Chi Mei PA-765A Rated V-1 or better, 1.6 mm thick min.
PAGE 27
page 25 of 27 Report No. 55S072147/NCH/CZ IEC 601 + Am. 1& 2 Clause Requirement + Test Object/part No Manufacturer/ trademark Switching Power DIVA Supply Result - Remark Type/model DMP8012 Technical data Verdict Standard I/P: 100-240Vac, IEC 60601-1: 50/60Hz, 1.41988+A1+A2 0.7A, Class I O/P: +12V, 7A Mark(s) of 1 conformity ) UL, TUV/R (CB Ref. Certificate No.:DE 2008837) LCD Panel (see Remark 4 on page 4) Sharp (Fujitsu) LQ190E1LW41 (FLC48SXC8V12) 19 inch, TFTLCD, 5Vdc, 3.5A max.
PAGE 28
page 26 of 27 Object/part No Manufacturer/ trademark Type/model Report No. 55S072147/NCH/CZ Technical data Standard Mark(s) of 1 conformity ) D/A Inverter (see TDK Remark 4 on page 4) TBD319LF-1, TBD319LF-2 (two models are identical to each other except for output connector) I/P: 12.6Vdc max., 3.3A max. O/P: 2000Vrms max., 7.5mA max. - -Inverter TDK Transformer (T1T6) NIA15/20EMT68H002 105°C - - D/A Inverter (see Ambit Remark 4 on page 4) 25L7623 I/P: 12.6Vdc max., 36W max.
PAGE 29
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.
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Page A1 of A6 Ref. No.
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Page A2 of A6 Ref. No.
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Page A4 of A6 Ref. No.
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Page A5 of A6 Ref. No.
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Page A6 of A6 Ref. No.: 55S072147/NCH/CZ Appendix 6 Letter of Declaration by “DIVA Laboratories Ltd.
PAGE 36
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-191. 1. ER-191 same as GODx7yzMI, GOKx7yzMI ( x can be A~Z.) just enclosure different and add IPX2 for this enclosure.