Page 1 of 4 Report Reference No. CPSZ IEC /EN Clause Requirement + Test Result Remark Verdict

Transcription

1 age 1 of 4 Report Reference No. CSZ Report Reference No... : Tested by (name and signature)... : Approved by (name and signature).. : TEST REORT IEC / EN Safety requirements for electrical equipment for measurement, control, and laboratory use art 1: General requirements CSZ Albert. Lee Harry. Kwon Date of issue... : Contents... : Modification Test Report Reference Number... : Modification to appliance... : 4 pages CSA Applicant address Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : Address... : Applicant s name... : Address... : Test specification: Standard... : Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : CE-LVD Same as above Boditech Med Inc Geoduri, Dongnaemyeon, Chuncheon, Gangwon-do, , Republic of KOREA EN : 2001 (2 nd Edition) CE-LVD IEC61010_C VDE Master TRF... : Dated Copyright 2001 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context.

2 age 2 of 4 Report Reference No. CSZ Test item description...: Trademark...: Model/Type reference...: Rating(s)...: Blood and urine analyzer Boditech i-chroma 12 V d.c., 3.0 A

3 age 3 of 4 Report Reference No. CSZ Test item particulars... : Blood and urine analyzer Type of item tested... : Laboratory (IVD equipment) Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : ollution degree... : 2 Environmental rating... : Normal Equipment mobility... : Movable Connection to mains supply... : Operating conditions... : Continuous Overall size of the equipment (L x W x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator.

4 age 4 of 4 Report Reference No. CSZ Copy of marking plate: Summary of test results (information/comments): ass - The presented unit was found to be in compliance with the standard of IEC/EN :2001, IEC/EN and IEC/EN

5 age 1 of 61 Report Reference No.... : Tested by (name and signature)... : Approved by (name and signature).. : TEST REORT IEC / EN Safety requirements for electrical equipment for measurement, control, and laboratory use art 1: General requirements CSA Edward.Yang Thomas.Kim Date of issue... : Contents... : Testing Laboratory... : 61 ages TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : Address... : Applicant s name... : Address... : Test specification: Standard... : Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : CE-LVD Same as above Boditech Med Inc. #3-2,Bioventure laza , HupyeongDong, Chuncheon, Kangwon, , Republic of Korea EN : 2001 (2 nd Edition) CE-LVD IEC61010_C VDE Master TRF... : Dated Copyright 2001 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trademark... : Model/Type reference... : Rating(s)... : Blood and urine analyzer Boditech i-chroma 12 V d.c., 3.0 A

6 age 2 of 61 Report Reference No. CSA Test item particulars... : Blood and urine analyzer Type of item tested... : Laboratory (IVD equipment) Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : ollution degree... : 2 Environmental rating... : Normal Equipment mobility... : Movable Connection to mains supply... : Operating conditions... : Continuous Overall size of the equipment (L x W x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : until General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator.

7 age 3 of 61 Report Reference No. CSA Copy of marking plate: Summary of test results (information/comments): ass - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN i-chroma is basic model which was tested. - For test, AC/DC adaptor model MU50-105, manufacturerd by Sinpro electronics Co., Ltd. was used.

8 age 4 of 61 Report Reference No. CSA TABLE: 1 - Documents attached to this report Document No. Document description age Numbers Attachment hotos 2

9 age 5 of 61 Report Reference No. CSA TABLE: 2 - Test equipment list Item Type Equipment Calibration date Comments 1-A Temperature & Humidity Chamber No. Last 1 Due ER-35MHH A Temperature Chamber ERH-432-2T A DC ower Supply DR305DN B Temperature Recorder DR A Dielectric Strength Tester TOS A DC ma Meter A True RMS Multi-Meter A IEC61032 Test robe B 1032-B A Drop Test Check Jig & Scale IT A Hard Wood Surface A Stop Watch HS B Isopropyl alcohol B ush-pull gauge DS-5K I IEC Fig.2C Test probe ) or interval between calibrations.

10 age 6 of 61 Report Reference No. CSA TABLE: 3 - List of components and circuits relied on for safety Unique component reference or location (including drawing reference if required) Application/Function Manufacturer (NOTE 1) AC/DC Adaptor - Sinpro electronics Co., Ltd. art number RATING (NOTE 2) MU Input : V~, Hz, 1.35 A Output : 12 V d.c., 3.75 A Evidence of acceptance (NOTE 3) UL, TUV Rheinland ower switch - Zhongxun KCD V~, 3 A TUV Rheinland Motor - Saehan Electronics 4S42Q-T12034SD 12 V d.c. Tested with appliance Lithium battery(bt1) - anasonic CR V d.c. Max. abnormal charging current : 10 ma LCD panel - Shenzhen Topway Technology co.,ltd Laser diode in measuring module LMB164ACD 6 V d.c., 1.3 ma Tested with appliance - QSI Co., Ltd. QL63D - SEMKO Enclosure - BASF Corp. G-35 Min.thickness 2.5 mm, HB UL UL CB - EUNSUNG ELECCOM.CO.LTD 1, 2 94V-0, 105, Min. thickness 1.6 mm UL NOTE 1 - List all manufacturers concerned. NOTE 2 - Electrical, mechanical, flammability, etc. NOTE 3 - Licence number, file number or other documentary evidence of acceptance

11 age 7 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 5 MARKING AND DOCUMENTATION General Required equipment markings are: visible: From the exterior; or After removing a cover; or Opening a door After removal from a rack or panel Not put on parts which can be removed by an OERATOR Identification Letter symbols (IEC 60027) used Graphic symbols (IEC : Table 1) used Equipment is identified by: 5.1.2a) Manufacturer s or supplier s name or trademark Boditech 5.1.2b) Model number, name or other means i-chroma Manufacturing location identified Mains supply 5.1.3a) Equipment is marked as follows: Nature of supply: 1) a.c. RATED mains frequency or range of frequencies... : 2) d.c. with symbol b) RATED supply voltage(s) or range... : 12 V d.c c) Max. RATED power (W or VA)or input current... : 3.0 A If more than one voltage range: Separate values marked; or Values differ by less than 20 % (see Form A.3) 5.1.3d) OERATOR-set for different RATED supply voltages: No such parts 5.1.3e) Indicates the equipment set voltage ORTABLE EQUIMENT indication is visible from the exterior Changing the setting changes the indication Accessory mains socket-outlets accepting standard mains plugs are marked: No such socket-outlets

12 age 8 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Fuses With the voltage if it is different from the mains supply voltage... : For use only with specific equipment If not marked for specific equipment it is marked with: The maximum RATED current or power; or Symbol 14 with full details in the documentation OERATOR replaceable fuse marking (see also 5.4.5)... : None of replaceable fuse TERMINALS, connections and operating devices Where necessary for safety, indication of purpose of TERMINALS, connectors, controls and indicators marked If insufficient space, symbol 14 used TERMINALS Mains supply TERMINALS identified Other TERMINAL marking... : a) FUNCTIONAL EARTH TERMINALS (symbol 5 used) b) ROTECTIVE CONDUCTOR TERMINALS: c) d) Symbol 6 is placed close to or on the TERMINAL; OR art of appliance inlet TERMINALS of measuring and control circuits (symbol 7 used) HAZARDOUS LIVE TERMINALS supplied from the interior Standard MAINS socket outlet; or RATINGS marked; or Symbol 14 used e) ACCESSIBLE FUNCTIONAL EARTH TERMINALS: Self-evident; or Indication (symbol 8 acceptable) Measuring circuit TERMINALS For TERMINALS other than those permanently connected and not ACCESSIBLE: RATED voltage or current marked Unless clear indication that below limits:

13 age 9 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Maximum RATED voltage to earth is marked; or For specific connection to other equipment TERMINALS only, and means for identifying provided Appropriate measurement category marked (CAT II, CAT III or CAT IV); or No measurement category marked (CAT I) Required markings are adjacent to TERMINALS; OR If insufficient space: On the RATING plate or scale plate; or TERMINAL is marked with symbol Switches and circuit breakers If disconnecting device, on or off position marked Equipment protected by DOUBLE INSULATION or REINFORCED INSULATION rotected throughout (symbol 11 used) Only partially protected (symbol 11 not used) Field-wiring TERMINAL boxes If TERMINAL or ENCLOSURE exceeds 60 C: (See Form A.21A) Cable temperature RATING marked Marking visible or beside TERMINAL 5.2 Warning markings Visible when ready for NORMAL USE Are near or on applicable parts Symbols and text correct dimensions and colour If necessary marked with symbol 14 Statement to isolate or disconnect 5.3 Durability of markings The required markings remain clear and legible in NORMAL USE 5.4 Documentation General Equipment is accompanied by documentation which includes: (see Form A.4) 5.4.1a) Intended use 5.4.1b) Technical specification 5.4.1c) Instructions for use

14 age 10 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 5.4.1d) Name and address of manufacturer or supplier 5.4.1e) Information specified in to f) 5.4.1g) If CAT 1: If marking of TERMINALS required, definition of measurement category Warning RATINGS Warning statements and a clear explanation of warning symbols: rovided in the documentation; or Information is marked on the equipment Equipment RATINGS Documentation includes: 5.4.2a) Supply voltage or voltage range (See copy of marking plate) Frequency or frequency range ower or current RATING (See copy of marking plate) 5.4.2b) Description of all input and output connections 5.4.2c) RATING of insulation of external circuits, when such circuits are nowhere ACCESSIBLE 5.4.2d) Statement of the range of environmental conditions 5.4.2e) Degree of protection (IEC 60529) Equipment installation Documentation includes instructions for: 5.4.3a) Assembly, location and mounting In manual 5.4.3b) rotective earthing 5.4.3c) Connections to supply In manual 5.4.3d) ERMANENTLY CONNECTED EQUIMENT: 1) Supply wiring requirements 2) If external switch or circuit-breaker, requirements and location recommendation 5.4.3e) Ventilation requirements 5.4.3f) Special services (e. g. air, cooling liquid) 5.4.3g) Maximum sound power level 5.4.3h) Instructions about sound pressure 5.4.3i) ermanently connected measuring TERMINALS: Measurement category

15 age 11 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict RATED maximum WORKING VOLTAGE or current Equipment operation Instructions for use include: 5.4.4a) Identification of operating controls 5.4.4b) ositioning for disconnection 5.4.4c) Interconnection 5.4.4d) Specification of intermittent operation limits 5.4.4e) Explanation of symbols used 5.4.4f) Replacement of consumable materials 5.4.4g) Cleaning and decontamination (see 11.2) In manual 5.4.4h) 5.4.4i) Listing of any poisonous or injurious gases and quantities Risk-reduction procedures relating to flammable liquids A statement about protection impairment if used in a manner not specified by the manufacturer Equipment maintenance Instructions include: Sufficient preventive maintenance and inspection information Replacement of hoses, etc. Specific battery type Any manufacturer specified parts RATING and characteristics of fuses 6 ROTECTION AGAINST ELECTRIC SHOCK (see Form A.5) 6.1 General Requirements Exceptions ACCESSIBLE parts not HAZADOUS LIVE in NORMAL CONDITION and SINGLE FAULT CONDITION Conformity is checked by the determination of 6.2 and 6.3 followed by the tests of 6.4 to 6.11 Capacitance test (see Forms A.6 and A.7) arts not HAZARDOUS LIVE 10 s after interruption of supply 6.2 Determination of ACCESSIBLE parts General examination (see Form A.6)

16 age 12 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Openings above parts that are HAZARDOUS LIVE Openings for pre-set controls 6.3 ermissible limits for ACCESSIBLE parts Values in NORMAL CONDITION (see Form A.7) Values in SINGLE FAULT CONDITION (see Form A.8) 6.4 rotection in NORMAL CONDITION (see 6.2, 6.3.1, 6.7, 6.8 and 8.1) 6.5 rotection in SINGLE FAULT CONDITION Additional protection is provided by: One or more of to 6.5.3; or Automatic disconnection of the supply (6.5.4) rotective BONDING ACCESSIBLE conductive parts: Separated by DOUBLE INSULATION or REINFORCED INSULATION; or Bonded to the ROTECTIVE CONDUCTOR TERMINAL; or Separated by screen or BARRIER bonded to ROTECTIVE CONDUCTOR TERMINAL from parts which are HAZARDOUS LIVE Integrity of ROTECTIVE BONDING a) ROTECTIVE BONDING consists of directly connected structural parts or discrete conductors or both; and withstands thermal and dynamic stresses b) Soldered connections: Independently secured Not used for other purposes Screw connections are secured c) ROTECTIVE BONDING not interrupted d) Any moveable connection specifically designed, and meets e) No external metal braid of cables used f) If MAINS supply passes through: g) Means provided for passing protective conductor; Impedance meets rotective conductors bare or insulated, if insulated, green/yellow Exceptions:

17 age 13 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 1) earthing braids; 2) internal protective conductors etc.; Green/yellow not used for other purposes h) TERMINAL suitable, and meets ROTECTIVE CONDUCTOR TERMINAL a) Contact surfaces are metal b) Appliance inlet used c) d) e) For rewireable cords and ERMANENTLY CONNECTED EQUIMENT, ROTECTIVE CONDUCTOR TERMINAL is close to MAINS supply TERMINALS If no MAINS supply is required, any ROTECTIVE CONDUCTOR TERMINAL: Is near TERMINALS of circuit for which protective earthing is necessary External if other TERMINALS external Equivalent current-carrying capacity to MAINS supply TERMINALS (see Form A.9) f) If plug-in, makes first and breaks last g) If also used for other bonding purposes, protective conductor: Applied first; Secured independently; Unlikely to be removed by servicing; or Warning marking requires replacement of protective conductor h) rotective conductor of measuring circuit: i) j) 1) Current RATING; 2) ROTECTIVE BONDING: Not interrupted; or Indirect bonding used (see ) FUNCTIONAL EARTH TERMINALS allow independent connection If a binding screw: Suitable size for bond wire Not smaller than M 4 (No. 6) At least 3 turns of screw engaged

18 age 14 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Contact pressure not capable of reduction by deformation of materials asses tightening torque test (see Form A.9) Impedance of ROTECTIVE BONDING of plugconnected equipment Bonding impedance of ERMANENTLY CONNECTED EQUIMENT (see Form A.10) (see Form A.10) Indirect bonding for measuring and test equipment (see Form A.11) DOUBLE INSULATION and REINFORCED INSULATION (see 6.7, 6.8 and 6.9.2) ROTECTIVE IMEDANCE (see Form A.12) 6.5.3a) HIGH-INTEGRITY single component used (s. 14.6); or 6.5.3b) A combination of components used; or 6.5.3c) A combination of BASIC INSULATION and current- or voltage-limiting device used Components, wires and connections are RATED as required Automatic disconnection of the supply If used, it meets : 6.5.4a) Supplied with the equipment; or Specified by installation instruction 6.5.4b) RATED disconnecting time within limit specified 6.5.4c) RATED for maximum RATED LOAD 6.6 Connections to external circuits General Connections do not cause ACCESSIBLE parts of the following to become HAZARDOUS LIVE in NORMAL CONDITION or SINGLE FAULT CONDITION: 6.6.1a) The external circuits 6.6.1b) The equipment Separation of circuits provided; or Short circuit of separation does not cause a Hazard Instructions or markings include: 1) RATED conditions for TERMINAL 2) Required RATING of external circuit insulation TERMINALS for external circuits

19 age 15 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict TERMINALS which receive a charge from an internal capacito are not HAZARDOUS LIVE (see Form A.7) High voltage TERMINALS energized from the interior are: Not ACCESSIBLE if connected; or Unmated HAZARDOUS LIVE TERMINALS not ACCESSIBLE ; or marked with symbol Circuits with TERMINALS which are HAZARDOUS LIVE These circuits are: Not connected to ACCESSIBLE conductive parts; or Connected to ACCESSIBLE conductive parts, but are not MAINS CIRCUITS and have one TERMINAL contact at earth potential No ACCESSIBLE conductive parts are HAZARDOUS LIVE ACCESSIBLE TERMINALS for stranded conductors 6.6.4a) No risk of accidental contact because: Located or shielded Self-evident or marked whether connected to ACCESSIBLE conductive parts 6.6.4b) ACCESSIBLE TERMINALS will not work loose 6.7 CLEARANCES and CREEAGE DISTANCES (See Form A.5 and A.13) 6.8 rocedure for dielectric strength tests (See Form A.5 and A.14) 6.9 Constructional requirements for protection against electric shock General If a failure could cause a HAZARD: 6.9.1a) Security of wiring connections 6.9.1b) Screws securing removable covers 6.9.1c) Sccidental loosening Easily damaged materials not used Non-impregnated hydroscopic materials not used ENCLOSURES of equipment with DOUBLE INSULATION or REINFORCED INSULATION ENCLOSURE surrounds all metal parts except for small metal parts which are separated ENCLOSURES or parts made of insulating material

20 age 16 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict rotection for metal ENCLOSURES or parts by: 6.9.2a) An insulating coating or BARRIER on the inside; or 6.9.2b) CLEARANCES and CREEAGE DISTANCES cannot be reduced by loosening of parts or wires Over-range indication Unambiguous 6.10 Connection to MAINS supply source and connections between parts of equipment MAINS supply cords a) RATED for maximum equipment current (see 5.1.3c) Cable complies with IEC or IEC b) Heat-resistant if likely to contact hot parts c) Temperature RATING (cord and inlet) d) Green/yellow used only for connection to ROTECTIVE CONDUCTOR TERMINALS Detachable cords with IEC MAINS connectors: Conform to IEC 60799; or Have the current RATING of the MAINS connector Fitting of non-detachable MAINS supply cords Non-detachable cord protection: a) Inlet or bushing smoothly rounded; or b) Insulated cord guard protruding =5D The protective earth conductor is the last to take the strain Cord anchorages: a) Cord is not clamped by direct pressure from a screw b) Knots are not used c) d) Cannot push the cord into the equipment to cause a hazard No failure of cord insulation in anchorage with metal parts e) compression bushing: 1) Clamps all types and sizes of MAINS cords; and 2) Is suitable: For connection to TERMINALS provided; or

21 age 17 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict f) It is designed for screened MAINS cord Cord replacement does not cause a HAZARD and method of strain relief is clear ush-pull test (see Form A.15) lugs and connectors a) b) c) MAINS supply plugs, connectors etc., conform with relevant specifications If equipment supplied at voltages below a) or from a sole source: lugs of supply cords do not fit MAINS sockets above RATED supply voltage MAINS-type plugs used only for connection to MAINS supply lug pins which receive a charge from an internal capacitor (See Form A.7) d) Accessory MAINS socket outlets: 1) Marking if accepts a standard MAINS plug (see 5.1.3e) 2) Input has a protective earth conductor if outlet has earth TERMINAL contact 6.11 Disconnection from supply source General Exceptions Disconnects all current carrying conductors DC connector was used a) Equipment supplied by low energy source; or b) Equipment connected to impedance protected supply; or c) Equipment constitues an impedance protected load Requirements according to type of equipment ERMANENTLY CONNECTED EQUIMENT and multiphase equipment a) Employs switch or circuit-breaker If switch or circuit-breaker is not part of the equipment, documentation specifies: Switch or circuit-breaker to be included in building installation b) Location c) Marking Single-phase cord-connected equipment

22 age 18 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Equipment is provided with: a) Switch or circuit-breaker; or b) Appliance coupler (disconnectable without TOOL); or c) Separable plug (without locking device) HAZARDS arising from function Emergency switch Emergency switch 1 m from the moving part Disconnecting devices Electrically close to the supply Switches and circuit-breakers When used as disconnection device: Meets IEC and IEC Marked to indicate function Not incorporated in MAINS cord Does not interrupt protective earth conductor If has other contacts meets separation requirements of 6.6 and Appliance couplers and plugs Where an appliance coupler or seperable plug is used as the disconnecting device (see ): Readily identifiable and easily reached by the OERATOR Single-phase ORTABLE EQUIMENT cord length 3 m rotective earth conductor connected first and disconnected last 7 ROTECTION AGAINST MECHANICAL HAZARDS 7.1 General Conformity is checked by 7.2 to Moving parts Moving parts not able to crush, etc. (see also ) If OERATOR access permitted: 7.2a) Access requires TOOL 7.2b) Statement about training 7.2c) Warning markings or symbol 14

23 age 19 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 7.3 Stability Marking of non-automatic means Conformity tests: 7.3a) 10 tilt test 7.3b) multi-directional force test 7.3c) downward force test 7.4 rovisions for lifting and carrying Handles or grips withstand four times weight Equipment >18 kg : Has means for lifting or carrying; or Directions in documentation 7.5 Wall mounting Mounting brackets withstand four times weight 7.6 Expelled parts Equipment contains or limits the energy rotection not removable without the aid of a TOOL 8 MECHANICAL RESISTANCE TO SHOCK AND IMACT After the tests of 8.1 to 8.2: Voltage tests (see Form A.14) Inspections: 8a) HAZARDOUS LIVE parts not accessible 8b) ENCLOSURE shows no cracks (hazard) 8c) CLEARANCES not less than their permitted values (see Form A.13) 8d) BARRIERS not damaged or loosened 8e) No moving parts exposed, except permitted by 7.2 8f) No damage which could cause spread of fire 9 ROTECTION AGAINST THE SREAD OF FIRE Conformity for each source of HAZARD or area of the equipment is checked by one of the following: (See Form A.16) 9a) Fault test of 4.4; or (See Forms A.1 and A.2) 9b) Application of 9.1 (eliminating or reducing the sources of ignition); or 9c) Application of 9.2 (containment of fire within the equipment)

24 age 20 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 9.1 Eliminating or reducing the sources of ignition within the equipment 9.1a) 1) Limited-energy circuit (see 9.3); or 2) Insulation meets the requirements for BASIC INSULATION; OR (see Form A.5 and A.14) Bridging the insulation does not cause ignition (see Form A.2) 9.1b) Surface temperature of liquids and parts (see 9.4.a) 9.1c) No ignition in circuits designed to produce heat (see Form A.2) 9.2 Containment of the fire within the equipment, should it occur 9.2a) 9.2b) Energizing of the equipment is controlled by an OERATOR held switch Enclosure is conform with constructional requirements of 9.2.1; and Requirements of 9.4b) or c) are met Constructional requirements 9.2.1a) Insulated wires have flammability classification FV1 or better Connectors and insulating material have flammability classification FV2 or better (see Table 3 or Form A.17) (see Table 3 or Form A.17) 9.2.1b) The enclosure is constructed as follows : 1) Bottom constructed with: No openings; or Extent as specified in figure 7; or Baffles as specified in figure 6; or erforated as specified in Table 12; or Metal screen with a mesh 2) Sides have no openings as specified in figure 7 3) Material of ENCLOSURE and any baffle or flame barrier is made of: Metal (except magnesium); or Non metallic materials have flammability classification FV1 or better 4) ENCLOSURE and any baffle or flame barrier have adequate rigidity (see Table 3 or Form A.17) 9.3 Limited-energy circuit (see Form A.19) 9.3a) otential not more than 30 r.m.s. and 42.4 V peak, or 60 V dc Within limits

25 age 21 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 9.3b) Current limited by one of following means: Certified AC/DC adaptor used 1) Inherently or by impedance; or 2) Overcurrent protective device; or 3) A regulating network limits also in SINGLE FAULT CONDITION 9.3c) Is separated by at least BASIC INSULATION If overcurrent protective device used: Fuse or a non adjustable electromechanical device 9.4 Requirements for equipment containing or using flammable liquids 9.4a) Flammable liquids contained in or specified for use with equipment do not cause spread of fire Risk is reduced to a tolerable level : (see Form A.19) The temperature of surface or parts in contact with flammable liquids is 25 C below fire point 9.4b) The quantity of liquid is limited 9.4c) Flames are contained within the equipment Detailed instructions for risk-reduction provided 9.5 Overcurrent protection Devices not in the protective conductor Fuses or single-pole circuit-breakers not fitted in neutral (multi-phase) ERMANENTLY CONNECTED EQUIMENT Overcurrent device: Fitted within the equipment; or Specified in manufacturer's instructions Other equipment rotection within the equipment 10 EQUIMENT TEMERATURE LIMITS AND RESISTANCE TO HEAT 10.1 Surface temperature limits for protection against burns Easily touched surfaces within the limits (see Form A.20A) Heated surfaces necessary for functional reasons exceeding specified values: Are recognizable as such by appearance or function; or

26 age 22 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict Are marked with symbol 13 Guards are not removable without TOOL 10.2 Temperatures of windings (see Form A.20B) Limits not exceeded in: NORMAL CONDITION SINGLE FAULT CONDITION 10.3 Other temperature measurements (see Form A.20A) 10.3a) 10.3b) Following measurements conducted if applicable: Value of 60 C of field-wiring TERMINAL box not exceeded Surface of flammable liquids and parts in contact with this liquids 10.3c) Surface of non-metallic ENCLOSURES 10.3d) arts made of insulating material supporting parts connected to MAINS supply 10.3e) TERMINALS carrying a current more than 0.5 A 10.4 Conduct of temperature test (see Form A20) 10.5 Resistance to heat Integrity of CLEARANCE and CREEAGE DISTANCES (See Form A.13) Non-metallic ENCLOSURES (See Forms A.21) After treatment: No HAZARDOUS LIVE parts ACCESSIBLE; Tests of 8.1 and 8.2 (See Form A.13) In case of doubt, tests of 6.8 (without humidity preconditioning) (See Form A.14) Insulating material a) arts supporting parts connected to MAINS supply b) TERMINALS carrying a current more than 0.5 A Examination of material data; or in case of doubt:: 1) Ball pressure test; or (See Form A.22) 2) Vicat softening testof ISO 306 (See Form A.22) 11 ROTECTION AGAINST HAZARDS FROM FLUIDS 11.1 General

27 age 23 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 11.2 Cleaning (See Form A.23) 11.3 Spillage (See Form A.23) 11.4 Overflow (See Form A.23) 11.5 Battery electrolyte Battery electrolyte leakage presents no hazard 11.6 Specially protected equipment (See Form A.23) 11.7 Fluid pressure and leakage Maximum pressure Maximum pressure of any part does not exceed RATED Leakage and rupture at high pressure (See Form A.24) Test to IEC (refrigeration only) Leakage from low-pressure parts (See Form A.24) Overpressure safety device a) Does not operate in NORMAL USE Meets ISO ; and It is conform with: Connected as close as possible to parts intended to be protected b) Easy access for inspection, maintenance and repair c) Adjustment only with TOOL d) No discharge towards person e) No HAZARD from deposit of discharged material f) Adequate discharge capacity g) No shut-off valve between overpressure safety device and protected parts 12 ROTECTION AGAINST RADIATION, INCLUDING LASER SOURCES, AND AGAINST SONIC AND ULTRASONIC RESSURE 12.1 General Equipment provides protection 12.2 Equipment producing ionizing radiation Ionizing radiation (See Form A.25) Accelerated electrons 12.3 Ultra-violet (UV) radiation (Conformity test under consideration)

28 age 24 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict No unintentional and HAZARDOUS escape of UV radiation 12.4 Micro-wave radiation ower density does not exceed 10 W/m 2... : 12.5 Sonic and ultrasonic pressure Sound level (See Form A.26) Ultrasonic pressure (See Form A.26) 12.6 Laser sources (IEC ) 13 ROTECTION AGAINST LIBERATED GASES, EXLOSION AND IMLOSION 13.1 oisonous and injurious gases Attached data/test reports demonstrate conformity 13.2 Explosion and implosion Components Components liable to explode: ressure release device provided; or Apparatus incorporates OERATOR protection (see also 7.6) ressure release device: Discharge without danger Cannot be obstructed Batteries and battery charging If explosion or fire hazard could occur: rotection incorporated in the equipment; or Instructions specify batteries with built-in protection In case of wrong type of battery used: No HAZARD; or Warning by marking and within instructions Equipment with means to charge rechargeable batteries: Warning against the charging of non-rechargeable batteries; and Type of rechargeable battery indicated; or Symbol 14 used Battery compartment design No such means Single component failure (See Form A.27)

29 age 25 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict olarity reversal test Not installed with polarity reversed Implosion of cathode ray tubes If maximum face dimensions > 160 mm... : Intrinsically protected and correctly mounted; or ENCLOSURE provides protection: If non-intrinsically protected: Screen not removable without TOOL If glass screen, not in contact with surface of tube Equipment RATED for high pressure (See 11.7) 14 COMONENTS 14.1 General 14.2 Motors Where safety is involved, components meet relevant requirements Motor temperatures Does not present a HAZARD when stopped or prevented form starting; or rotected by overtemperature or thermal protection device conform with 14.3 (see Table 3) (See Form A.20) Series excitation motors Connected direct to device, if overspeeding causes a HAZARD 14.3 Overtemperature protection devices Devices operating in a SINGLE FAULT CONDITION (See Form A.28) 14.3a) Reliable function is ensured 14.3b) RATED to interrupt maximum current and voltage 14.3c) Does not operate in NORMAL USE 14.4 Fuse holders No access to HAZARDOUS LIVE parts 14.5 Mains voltage selecting devices Accidental change not possible 14.6 HIGH INTEGRITY components Used in applicable positions (see Table 3) Conforms with IEC publications Single electronic device not used

30 age 26 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict 14.7 Mains transformers tested outside equipment (See Forms A.29 and A.30) 14.8 rinted circuit boards Data shows conformity with FV-1 of IEC or better; or Test shows conformity with FV-1 of IEC or better; or Thin film flexible CB with limited-energy circuit used 14.9 Circuits or components used as transient overvoltage limiting devices (See Table 3) (See Form A.17) After test, no sign of overload or degradation 15 ROTECTION BY INTERLOCKS 15.1 General Interlocks are designed to remove a hazard before OERATOR exposed 15.2 revention of reactivation 15.3 Reliability Single fault unlikely to occur; or Cannot cause a HAZARD 16 TEST AND MEASUREMENT EQUIMENT 16.1 Current measuring circuits (see Form A.31) 16.2 Multifunction meters and similar equipment (see Form A.32) No HAZARD from: RATED input voltage combinations Settings of functions Settings of range controls ANNEX F ROUTINE TESTS Manufacturer s declaration

31 age 27 of 61 Report Reference No. CSA Clause Requirement + Test Result - Remark Verdict TABLE: Summary of SINGLE FAULT CONDITIONS Form A.1 Subclause Title Does not apply ROTECTIVE IMEDANCE X rotective conductor X Equipment or parts for short-term or intermittent operation X Carried out Comments Motors X Capacitors X Mains transformers Attach drawing of MAINS Txs showing all protective devices (see Forms A.29 and A.30) Outputs X Equipment for more than one supply X Cooling air holes closed X fans stopped X coolant stopped X Heating devices timer overridden X temperature controller overridden X loss of cooling liquid X overfilled or empty or both X Insulation between circuits and parts X Interlocks X List below all SINGLE FAULT CONDITIONS not covered by to : Batteries X Supplementary information: (see Form A.2 for details of tests) X

32 age 28 of 61 Report Reference No. CSA TABLE: Testing in single FAULT CONDITION Results Form A.2 Test subclause Fault No. Fault description Td (NOTE) How was test terminated Comments Component(EC1) short-circuited, Sample #1-1/3 30 min. rotect circuit operated. No hazards. NB Component(EC1) short-circuited, Sample #1-2/3 30 min. rotect circuit operated. No hazards. NB Component(EC1) short-circuited, Sample #1-3/3 30 min. rotect circuit operated. No hazards. NB Meets Component(D1,1-3) short-circuited, Sample #1-1/ Component(D1,1-3) short-circuited, Sample #1-2/ Component(D1,1-3) short-circuited, Sample #1-3/ Component(D1,2-4) short-circuited, Sample #1-1/ Component(D1,2-4) short-circuited, Sample #1-2/ Component(D1, 2-4) short-circuited, Sample #1-3/3 30 min. rotect circuit operated. No hazards. NB 30 min. rotect circuit operated. No hazards. NB 30 min. rotect circuit operated. No hazards. NB 30 min. rotect circuit operated. No hazards. NB 30 min. rotect circuit operated. No hazards. NB 30 min. rotect circuit operated. No hazards. NB NOTE Td = Test duration in h:min:s Record dielectric strength test on Form A.14 and temperature tests on Form A.20. Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION.

33 age 29 of 61 Report Reference No. CSA c) TABLE: Mains supply Form A.3 Marked rating... : 3 V d.c. hase... : Frequency...: - Hz Current...: - A ower...: - W ower...: - VA Test Voltage Frequency Current ower in ower in Comments No. V Hz A W VA Max. Normal load Max. Normal load Max. Normal load Max. Normal load Max. Normal load Max. Normal load Max. Normal load Max. Normal load 9 12 V d.c Max. Normal load, Sample #1-1/ V d.c Max. Normal load, Sample #1-2/ V d.c Max. Normal load, Sample #1-3/3 Note: Measurements are only required for marked ratings. Supplementary information: From test no.1 to 8 are for references.

34 age 30 of 61 Report Reference No. CSA TABLE: Durability of markings Form A.4 Marking method (see NOTE) Agent 1) Silk-screened A Water 2) rinted on label by ink B Isopropyl alcohol 3) C Hexan 99% 4) D (specify agent) 5) E (specify agent) NOTE Where applicable include print method, label material, ink or paint type, fixing method, adhesive and surface to which marking is fixed. Marking location Identification (5.1.2) 2) Mains supply (5.1.3) 2) Fuses (5.1.4) TERMINALS and operating devices ( ) Measuring circuit TERMINALS ( ) Switches and cricuit breakers (5.1.6) DOUBLE/REINFORCED equipment (5.1.7) Field wiring TERMINAL boxes (5.1.8) Warning marking (5.2) Battery charging (13.2.2) Marking method (see above) Method Test agent Remains legible Label loose Curled edges Comments Verdict Verdict Verdict Rubbed B Yes No No Sample #1-1/3 Rubbed B Yes No No Sample #1-2/3 Rubbed B Yes No No Sample #1-3/3

35 age 31 of 61 Report Reference No. CSA TABLE: rotection against electric shock - Block diagram of system Form A.5 A EUT 12 V d.c. Certified AC/DC Adaptor ollution degree... : 2 Installation category (overvoltage category)... : Location or Insulation type Maximum working description (NOTE 1) voltage (NOTE 2) WB mm CREEAGE DISTANCE (NOTE 3) CTI Other mm CLEARANCE (NOTE 3) Test voltage CTI mm (NOTE 2) V Comments A DI 240 V V rms Certified AC/DC adaptor NOTE 1 Type of insulation: NOTE 2 - Types of voltage NOTE 3 - INSTALLATION CATEGORIES (OVERVOLTAGE CATEGORIES) BI = BASIC INSULATION eak impulse test voltage (pulse) or OLLUTION DEGREES which differ from DI = DOUBLE INSULATION r.m.s. these should be shown under "Comments". I = ROTECTIVE IMEDANCE d.c. RI = Reinforced INSULATION peak SI = Supplementary INSULATION FI = Functional Insulation Supplementary Information:

36 age 32 of 61 Report Reference No. CSA TABLE: List of ACCESSIBLE parts Form A Exceptions 6.2 Determination of accessible parts Item Description Determination method (NOTE 5) Exception under (NOTE 4) 1 Enclosure, outside (Sample #1-1/3) Test finger No 2 Serial port, outside (Sample #1-1/3) Test finger No 3 Adaptor output (Sample #1-1/3) Test finger No 4 Enclosure, outside (Sample #1-2/3) Test finger No 5 Serial port, outside (Sample #1-3/3) Test finger No 6 Adaptor output (Sample #1-2/3) Test finger No 7 Enclosure, outside (Sample #1-3/3) Test finger No 8 Serial port, outside (Sample #1-3/3) Test finger No 9 Adaptor output (Sample #1-3/3) Test finger No NOTE 1 Test fingers and pins are to be applied without force unless a force is specified (see 6.2.1) NOTE 2 Special consideration should be given to inadequate insulation and high voltage parts (see 6.2) NOTE 3 arts are considered to be ACCESSIBLE if they could be touched in the absence of any covering which is not considered to provide suitable insulation (see note to paragraph 1 of 6.4). NOTE 4 Capacitor test may be required (see Form A.7). NOTE 5 The determination methods are: visual; rigid test finger; jointed test finger; pin 3 mm diameter; pin 4 mm diameter. Supplementary information

37 age 33 of 61 Report Reference No. CSA TABLE: Values in NORMAL CONDITION Form A Exceptions 11.2 Cleaning and decontamination Values in NORMAL CONDITION (see NOTE 1) 11.3 Spillage Terminals for external circuit 11.4 Overflow lugs and connections Item Voltage Current Capacitance 10 s test (NOTE 2) Comments (see Form A.6) V r.m.s. V peak V d.c. Test circuit A1/A2/A3 ma r.m.s. ma peak ma d.c. C mj V C mj Sample # 1-1/ Sample # 1-1/ A Sample # 1-1/ Sample # 1-2/ Sample # 1-2/ A Sample # 1-2/ Sample # 1-3/ Sample # 1-3/ A Sample # 1-3/3 NOTE 1 The requirements of include drying out (if specified). For permanently connected equipment, the current values are 1,5 times the specified values. NOTE 2 A 5 s test is specified in c).

38 age 34 of 61 Report Reference No. CSA TABLE: Values in SINGLE FAULT CONDITION Form A.8 Item (See Form A.6) Subclause and fault No. (see FormA.2) 1 Clause 4.4.2, No.1,4,7 2 Clause 4.4.2, No.1,4,7 3 Clause 4.4.2, No.1,4,7 4 Clause 4.4.2, No.2,5,8 5 Clause 4.4.2, No.2,5,8 6 Clause 4.4.2, No.2,5,8 7 Clause 4.4.2, No.3,6,9 8 Clause 4.4.2, No.3,6,9 9 Clause 4.4.2, No.3,6,9 V r.m.s. Voltage V peak Transient (see NOTE) V d.c. V s Test circuit A1/A2/A3 Current ma r.m.s. ma peak ma d.c Capacitance F (NOTE) A A A NOTE Transient voltages must be below the limits given from Figure 1 and the capacitance below the limits from figure 2 of IEC Sample # 1-1/3 Sample # 1-1/3 Sample # 1-1/3 Sample # 1-2/3 Sample # 1-2/3 Sample # 1-2/3 Sample # 1-3/3 Sample # 1-3/3 Sample # 1-3/3 Comments

39 age 35 of 61 Report Reference No CSA TABLE: Cross-sectional area of bonding conductors Form A.9 Conductor location Cross-sectional area mm 2 Verdict TABLE: Tighting torque test Conductor location Size of Screw Tighting torque Nm Verdict

40 age 36 of 61 Report Reference No CSA TABLE: Bonding impedance of plug connected equipment Form A.10 ACCESSIBLE part under test Test current A Voltage attained after 1 min V Calculated resistance (maximum allowed 0,1 ) Verdict Supplementary information: TABLE: Bonding impedance of ERMANENTLY CONNECTED EQUIMENT ACCESSIBLE part under test Test current A Voltage attained after 1 min (maximum 10 V) V Verdict Supplementary information:

41 age 37 of 61 Report Reference No CSA TABLE: Indirect bonding for measuring and test equipment Form A.11 ACCESSIBLE part under test Voltage attained s Time for voltage to drop to allowable levels s a) Voltage limiting device Verdict Supplementary Information: ACCESSIBLE part under test Voltage applied V Time for device to trip s Verdict b) Voltage-sensitive tripping device Supplementary Information:

42 age 38 of 61 Report Reference No CSA TABLE: ROTECTIVE IMEDANCE Form A.12 A high INTEGRITY single component Component Location Comments A combination of components Component Location Comments A combination of BASIC INSULATION and a current or voltage limiting device Component Location Comments Supplementary information:

43 age 39 of 61 Report ReferenceNo. CSA TABLE: CLEARANCES and CREEAGE DISTANCES Form A.13 8 Mechanical resistance to shock and impact Integrity of CLEARANCES and CREEAGE DISTANCES Location (see Form A.5) Measured Test at Measured after test Verdict Mechanical tests (note) (initial 6.7) max. (if required) CREEAGE CLEARANCE Applied Rigidity Drop RATED CREEAGE CLEARANCE DISTANCE force (8.1) (8.2) ambient DISTANCE mm mm (6.7) N Static Dynamic Normal Hand-held/ (10.5.1) mm mm lug-in A N 5 J Corne r drop A N 5 J Corne r drop A N 5 J Corne r drop Verdict Comments Sample #1-1/3 (With certified AC/DC adaptor) Sample #1-2/3 (With certified AC/DC adaptor) Sample #1-2/3 (With certified AC/DC adaptor) NOTE Refer to Form A.12 for dielectric strength tests following the above tests.

44 age 40 of 61 Report Reference No. CSA TABLE: Dielectric strength tests Form A b) Conformity after application of fault conditions rotection in NORMAL CONDITION DOUBLE INSULATION and REINFORCED INSULATION Connections to external circuits c) CLEARANCE values General: reduced CLEARANCES for homogeneous construction Fitting of non-detachable MAINS SULY cords 1 8 Mechanical resistance to shock and impact 9.1 a) 2) Eliminating or reducing the sources of ignition within the equipment 9.3 c) Limited-energy circuit 11.2 Cleaning Spillage Overflow Specially protected equipment 1 1 Record the fault, test or treatment applied before the dielectric strength test Location or references from Forms A.2 and A.5 Test site altitude... : 250m Test voltage correction factor (see Table 10)... : - Clause or sub-clause Humidity Yes/No Working voltage V Test voltage r.m.s./peak/d.cv Comments A, Sample #1-1/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/3 8 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/3 8 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/3 8 No 240 Vrms 2224 Vrms No breakdown Supplementary information: Cut off current 10 ma Verdict

45 age 41 of 61 Report Reference No. CSA TABLE: Cord anchorage Form A.15 Location Mass kg ull N Verdict Torque Nm Verdict Comment Supplementary information:

46 age 42 of 61 Report Reference No CSA TABLE: rotection against the spread of fire Form A.16 Item Source of HAZARD or area of the equipment considered (circuit, component, liquid etc.) rotection Method (9a, 9b or 9c) rotection details 1 Certified AC/DC adaptor, Sample #1-1/3 9a, 9b Certified AC/DC adaptor which was fullfilled max. limitations 2 Certified AC/DC adaptor, Sample #1-2/3 9a, 9b Certified AC/DC adaptor which was fullfilled max. limitations 3 Certified AC/DC adaptor, Sample #1-3/3 9a, 9b Certified AC/DC adaptor which was fullfilled max. limitations Verdict Supplementary information:

47 age 43 of 61 Report Reference No. CSA TABLE: Constructional requirements Form A rinted circuit boards Material tested... : Generic name... : Material manufacturer... : Type... : Colour... : Conditioning details... : Thickness of specimen Duration of flaming after first Application Duration of flaming plus glowing After second application Specimen burns to holding clamp Cotton ignited Sample result Supplementary information: Sample 1 Sample 2 Sample 3 mm s s Yes/No Yes/No ass/fail

48 age 44 of 61 Report Reference No. CSA TABLE: Limited-energy circuit Form A.18 Item 9.3 a) 9.3 b) Current and power limitation 9.3 c) Decision or Location (see Form A.16) Maximum potential in circuit voltage r.m.s./d.c. V Maximum available current A Maximum available power VA Overload protection after 120 s A Circuit separation Yes/No Comments Supplementary information:

49 age 45 of 61 Report Reference No. CSA TABLE: Requirements for equipment containing or using flammable liquids Form A.19 Type of liquid 9.4 Flammable liquids Verdict b) quantity c) Containment Supplementary information:

50 age 46 of 61 Report Reference No. CSA TABLE : Temperature Measurements Form A.20A 10.1 Surface temperature limits - NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.2 Temperature of windings- NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.3 Other temperature measurements Operating conditions: Max. Normal load conditions. Sample #1-1/3 Frequency... : 60 Hz Test room ambient temperature (t a )... : 23.2 C Voltage... : 264 V Test duration... : 1 h 44 min art / Location t m C t c C t max C Verdict Comments DC input connector body Tested with certified adaptor D1 body Tested with certified adaptor J11 body Tested with certified adaptor CB near U Tested with certified adaptor Battery body Tested with certified adaptor Motor body Tested with certified adaptor Measuring module body Tested with certified adaptor LCD body Tested with certified adaptor Inside enclosure (top) Tested with certified adaptor Outside enclosure (top) Tested with certified adaptor Adaptor body (enclosure top) Tested with certified adaptor Ambient Tested with certified adaptor NOTE 1 - t m = measured temperature t c = t m corrected (t m t a+ 40 C or max. RATED ambient) t max = maximum permitted temperature NOTE 2 - See also 14.1 with reference to component operating conditions NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary NOTE 4 - See Form A.20B for details of winding temperature measurements Supplementary information:

51 age 47 of 61 Report Reference No. CSA TABLE : Temperature Measurements Form A.20A 10.1 Surface temperature limits - NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.2 Temperature of windings- NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.3 Other temperature measurements Operating conditions: Max. Normal load conditions. Sample #1-2/3 Frequency... : 60 Hz Test room ambient temperature (t a )... : 23 C Voltage... : 264 V Test duration... : 2 h 4 min art / Location t m C t c C t max C Verdict Comments DC input connector body Tested with certified adaptor D1 body Tested with certified adaptor J11 body Tested with certified adaptor CB near U Tested with certified adaptor Battery body Tested with certified adaptor Motor body Tested with certified adaptor Measuring module body Tested with certified adaptor LCD body Tested with certified adaptor Inside enclosure (top) Tested with certified adaptor Outside enclosure (top) Tested with certified adaptor Adaptor body (enclosure top) Tested with certified adaptor Ambient Tested with certified adaptor NOTE 1 - t m = measured temperature t c = t m corrected (t m t a+ 40 C or max. RATED ambient) t max = maximum permitted temperature NOTE 2 - See also 14.1 with reference to component operating conditions NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary NOTE 4 - See Form A.20B for details of winding temperature measurements Supplementary information:

52 age 48 of 61 Report Reference No. CSA TABLE : Temperature Measurements Form A.20A 10.1 Surface temperature limits - NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.2 Temperature of windings- NORMAL CONDITION and / or SIGNLE FAULT CONDITION 10.3 Other temperature measurements Operating conditions: Max. Normal load conditions. Sample #1-2/3 Frequency... : 60 Hz Test room ambient temperature (t a )... : 22 C Voltage... : 264 V Test duration... : h 55 min art / Location t m C t c C t max C Verdict Comments DC input connector body Tested with certified adaptor D1 body Tested with certified adaptor J11 body Tested with certified adaptor CB near U Tested with certified adaptor Battery body Tested with certified adaptor Motor body Tested with certified adaptor Measuring module body Tested with certified adaptor LCD body Tested with certified adaptor Inside enclosure (top) Tested with certified adaptor Outside enclosure (top) Tested with certified adaptor Adaptor body (enclosure top) Tested with certified adaptor Ambient Tested with certified adaptor NOTE 1 - t m = measured temperature t c = t m corrected (t m t a+ 40 C or max. RATED ambient) t max = maximum permitted temperature NOTE 2 - See also 14.1 with reference to component operating conditions NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary NOTE 4 - See Form A.20B for details of winding temperature measurements Supplementary information:

53 age 49 of 61 Report Reference No. CSA TABLE: Temperature of windings Resistance method Temperature Measurements Form A.20B MAINS Transformers Motor temperatures Operating conditions: Frequency... : Hz Test room ambient temperature (t a1 /t a2 )... : / C (initial / final) Voltage... : V Test duration... : h min art / Designation R cold R warm Current A t r K t c C t max C Verdict Comments NOTE 1- R cold = initial resistance R warm = final resistance t r = temperature rise t c = t r corrected (t c= t r - { t a2 - t a1} + [40 C or max RATED ambient]) t max = maximum permitted temperature NOTE 2 - Indicate insulation class (IEC 85) under comments (optional) NOTE 3 - Record values for NORMAL CONDITION and / or SINGLE FAULT CONDITION in this Form use additional form if necessary Supplementary information:

54 age 50 of 61 Report Reference No. CSA TABLE: Resistance to heat of non-metallic enclosures Form A.21 Test method used: Non operative treatment... : [ x ] Empty ENCLOSURE... : [ ] Operative treatment... : [ ] Temperature during tests... : 70 C ENCLOSURE samples tested were... : Description Material Comments Verdict Enclosure, Sample #1-1/3 Enclosure, Sample #1-2/3 Enclosure, Sample #1-3/3 Non-metallic Not damaged Non-metallic Not damaged Non-metallic Not damaged Dielectric strength test (6.8)... : 2224 V rms Supplementary information:

55 age 51 of 61 Report Reference No. CSA TABLE: Insulating Materials Form A a) Ball pressure test Max. allowed impression diameter... : 2 mm art Test temperature C Impression Diameter (mm) Verdict Supplementary information: b) Vicat softening test (ISO 306) art Vicat softening temperature C Thickness of sample (mm) Verdict Supplementary information:

56 age 52 of 61 Report Reference No. CSA TABLE: Mechanical resistance to shock and impact Form A rotection against hazards from fluids Voltage tests can be carried out once after performing the tests of clause 8 and clause 11. However, if voltage tests are carried out separately after each set of tests, two forms can be used. Location (see form A.5) Clause 8 tests Static Dynamic Normal Handheld lug-in A 30 N 5 J Corner drop A 30 N 5 J Corner drop A 30 N 5 J Corner drop Cleaning (11.2) - Isopropyl alchol - Isopropyl alchol - Isopropyl alchol Clause 11 tests Spillage (11.3) Overflow (11.4) IEC (11.6) Working voltage V Test voltage V Verdict Comments V 2224 V Sample #1-1/3 (With certified AC/DC adaptor) V 2224 V Sample #1-2/3 (With certified AC/DC adaptor) V 2224 V Sample #1-3/3 (With certified AC/DC adaptor) NOTE Use r.m.s., d.c. or peak to indicate the used test voltage.

57 age 53 of 61 Report Reference No. CSA TABLE: Leakage and rupture at high pressure Form A.24 art Maximum permissible working pressure Ma Test pressure Ma Leakage YES / NO Burst YES / NO Comments Supplementary information: Leakage from low-pressure parts art Test pressure Ma Leakage YES / NO Comments Supplementary information:

58 age 54 of 61 Report Reference No. CSA TABLE: Ionizing radiation Form A.25 Locations tested Measured values µsv/h Verdict Comments Supplementary information:

59 age 55 of 61 Report Reference No. CSA TABLE: Sound level Form A.26 Locations tested At operator s normal position and at bystanders positions a) b) c) d) e) Supplementary information: Measured values dba Calculated maximum sound pressure level Ultrasonic pressure Locations tested Measured values Comments At OERATOR S normal position At 1 m from the ENCLOSURE a) b) c) d) e) db khz NOTE No limit is specified at present, but a limit of 110 db above the reference pressure value of 20 a is under consideration for applicable frequencies between 20 khz and 100 khz. Supplementary information:

60 age 56 of 61 Report Reference No. CSA TABLE: Batteries Form A.27 Battery load and charging circuit diagram: Battery type...: Lithium battery Battery manufacturer/model/catalogue No....: anasonic / CR2032 Battery ratings...: DC 3V Reverse polarity instalment test No hazard Single component failures Verdict Component Open circuit Short circuit U12(6,8), Sample #-1-1/3 No hazard. U12(6,8), Sample #-1-2/3 No hazard. U12(6,8), Sample #-1-3/3 No hazard. Supplementary information: No hazard

61 age 57 of 61 Report Reference No. CSA TABLE: Overtemperature protection devices Form A.28 Reliability test Component Type (note) Verdict Comments NOTE: NSR = non-self-resetting (10 times) NR = non-resetting (1 time) SR = self-resetting (200 times) Supplementary information:

62 age 58 of 61 Report Reference No. CSA TABLE: Mains transformer Form A Short circuit MAINS transformers tested outside equipment Type...: Manufacturer...: Test in equipment Test on bench Test repeated inside equipment (see 14.7) Optional Insulation class (IEC 60085) of the lowest RATED winding...: Winding identification Type of rotector for winding (Note 1) Elapsed time Current, A primary secondary Winding temperature, C primary (see Note 2) secondary Tissue paper / cheesecloth OK? (ass / Fail) Voltage tests (see Note 3) primary to secondary primary to core secondary to secondary secondary to core Verdict V V V V Note 1: rimary fuse - F / ( ) A Secondary fuse - SF / ( ) A Overtemperature protection - O / ( ) C Impedance protection - Z Note 2: Indicate method of measurement TC = with thermocouple R = resistance method If resistance method is used,record resistance in cold and warm condition in FormA.20B! Note 3: Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and for results use NB = no breakdown or B = breakdown Supplementary information:

63 age 59 of 61 Report Reference No. CSA TABLE: Mains transformer Form A Overload tests (for mains transformers) Type...: Manufacturer...: Test in equipment Test on bench Test repeated inside equipment (see 14.7) Optional Insulation class (IEC 60085) of the lowest RATED winding...: Winding identification Type of rotector for winding (Note 1) Elapsed time Current, A primary secondary Winding temperature, C primary (see Note 2) secondary Tissue paper / cheesecloth OK? (ass / Fail) Voltage tests (see Note 3) primary to secondary primary to core secondary to secondary secondary to core Verdict V V V V Note 1: rimary fuse - F / ( ) A Secondary fuse - SF / ( ) A Overtemperature protection - O / ( ) C Impedance protection - Z Note 2: Indicate method of measurement TC = with thermocouple R = resistance method If resistance method is used,record resistance in cold and warm condition in FormA.20B! Note 3: Record the voltage applied and the type of voltage (r.m.s. / d.c. / peak) and for results use NB = no breakdown or B = breakdown Supplementary information:

64 age 60 of 61 Report Reference No. CSA TABLE: Current measuring circuits Form A.31 These tests are performed with all types and models of current transformers without internal protection, and which are specified by the manufacturer for use with the equipment a) Current transformers Type/Model RATED current A Test current A Interrupt Yes / No Verdict Comments Supplementary information: b) Range changing switches Type / Model Maximum rated current of switch A Cycling test Verdict Comments Supplementary information:

65 age 61 of 61 Report Reference No. CSA TABLE: Multifunctional meters and similar equipment Form A.32 Operating conditions...: Maximum RATED voltage applied (V)... : Measurement category... : Test source limit (KVA)... : Function Range Verdict Supplementary information:

66 age 1 of 5 Report Reference No.: CSZ TEST REORT IEC / EN Safety requirements for electrical equipment for measurement, control, and laboratory use art 2-101: articular requirements for in vitro diagnostic (IVD) medical equipment Report Reference No.... : Compiled by (+ signature)... : Approved by (+ signature)... : Date of issue... : Contents... : Modification Test Report Reference Number... : Modification to appliance... : CSZ Albert. Lee Harry. Kwon pages CSA Applicant address CB / CCA Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location... : CBTL SMT TM Address... : Applicant s name... : Address... : Test specification: Standard... : Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : Same as above Boditech Med Inc Geoduri, Dongnaemyeon, Chuncheon, Gangwon-do, , Republic of KOREA IEC : 2002 (ed.1) EN : 2002 (ed.1) CE-LVD IECEN61010_2_101A VDE Master TRF... : Dated February 2004 Copyright 2004 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context.

67 age 2 of 5 Report Reference No.: CSZ Test item description... : Trade Mark...: Manufacturer...: Model/Type reference...: Ratings...: Blood and urine analyzer Boditech Same as applicant i-chroma 12 V d.c., 3.0 A

68 age 3 of 5 Report Reference No.: CSZ Copy of marking plate: Summary of testing: ass - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN

69 age 4 of 5 Report Reference No.: CSZ Test item particulars... : Blood and urine analyzer Type of item tested : Laboratory (IVD) Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : ollution degree... : 2 Environmental rating... : Standard Equipment mobility... : Movable Connection to mains supply... : Operating conditions... : Continuous Overall size of the equipment (W x D x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : IX0 Accessories and detachable parts included... : Other options included... : ossible test case verdicts: - test case does not apply to the test object...: - test object does meet the requirement...: (ass) - test object does not meet the requirement...: F(Fail)

70 age 5 of 5 Report Reference No.: CSZ General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. The test results presented in this report relate only to the object tested. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. "(see Enclosure #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report. Throughout this report, a point is used as the decimal separator. List of test equipment must be kept on file and available for review. This Test Report is intended for the investigations of laboratory equipment for in vitro diagnostic (IVD) use and shall not be used without the CB Test Report covering the evaluation of the product according to IEC , art 1, General Requirements. This Test Report includes the assessment of group differences to complete the assessment according to the last valid edition the relevant EN standards. Those requirements / differences are included at the end of the test case section (main body). General product information: - The presented unit was found to be in compliance with the standard of IEC/EN :2001, IEC/EN and IEC/EN

71 age 1 of 9 TEST REORT IEC / EN Safety requirements for electrical equipment for measurement, control, and laboratory use art 2-101: articular requirements for in vitro diagnostic (IVD) medical equipment Report Reference No.... : Compiled by (+ signature)... : Approved by (+ signature)... : CSA Edward. Yang Thomas. Kim Date of issue... : CB / CCA Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location... : CBTL SMT TM Address... : Applicant s name... : Address... : Test specification: Standard... : Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : Same as above Boditech Med Inc. #3-2,Bioventure laza , HupyeongDong, Chuncheon, Kangwon, , Republic of Korea IEC : 2002 (ed.1) EN : 2002 (ed.1) CE-LVD IECEN61010_2_101A VDE Master TRF... : Dated February 2004 Copyright 2004 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trade Mark... : Manufacturer... : Model/Type reference... : Ratings... : Blood and urine analyzer Boditech Same as applicant i-chroma 12 V d.c., 3.0 A Test Report IEC/EN A Rev. 00 /

72 age 2 of 9 Report Reference No.: CSA Copy of marking plate: Summary of testing: ass - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN Test Report IEC/EN A Rev. 00 /

73 age 3 of 9 Report Reference No.: CSA Test item particulars... : Blood and urine analyzer Type of item tested : Laboratory (IVD) Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : ollution degree... : 2 Environmental rating... : Standard Equipment mobility... : Movable Connection to mains supply... : Operating conditions... : Continuous Overall size of the equipment (W x D x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : IX0 Accessories and detachable parts included... : Other options included... : ossible test case verdicts: - test case does not apply to the test object...: - test object does meet the requirement...: (ass) - test object does not meet the requirement...: F(Fail) Test Report IEC/EN A Rev. 00 /

74 age 4 of 9 Report Reference No.: CSA General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. The test results presented in this report relate only to the object tested. This report shall not be reproduced, except in full, without the written approval of the Issuing testing laboratory. "(see Enclosure #)" refers to additional information appended to the report. "(see appended table)" refers to a table appended to the report. Throughout this report, a point is used as the decimal separator. List of test equipment must be kept on file and available for review. This Test Report is intended for the investigations of laboratory equipment for in vitro diagnostic (IVD) use and shall not be used without the CB Test Report covering the evaluation of the product according to IEC , art 1, General Requirements. This Test Report includes the assessment of group differences to complete the assessment according to the last valid edition the relevant EN standards. Those requirements / differences are included at the end of the test case section (main body). General product information: - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN i-chroma is basic model which was tested. - For test, AC/DC adaptor model MU50-105, manufacturerd by Sinpro electronics Co., Ltd. was used. Test Report IEC/EN A Rev. 00 /

75 age 5 of 9 Report Reference No.: CSA Clause Requirement + Test Result - Remark Verdict 5. MARKING AND DOCUMENTATION General Additional symbols cannot be confused with the international ones Identification Equipment is identified by: 5.1.2a) Manufacturer s name or trademark and address Boditech 5.1.2b) Model number, name or other means i-chroma 5.1.2c) The name and address of the authorized representative of the manufacturer The equipment or packaging or the instructions for use include: 1) The serial-number or the batch code preceded by LOT symbol 102 of table 1 2 i) Indication that the equipment is IVD medical equipment 2 ii) Indication that the equipment is self-test IVD medical equipment On the label No self-test IVD medical equipment 2 iii) Identification of detachable components 2 iv) Expiry date of consumable parts Transport and storage ackaging labelled to indicate special conditions for transport or storage In manual 5.2 Warning markings otentially infectious equipment marked with symbol 101 of table 1 Equipment that can be hazardous due to the use of chemical substances marked with the appropriate symbol; or with Symbol 14 of Table 1 (if none is available) Containers or bags for biohazardous waste material which can be removed from the equipment during NORMAL USE marked with symbol 101 of table Durability of markings The required markings resist the effects of temperature and rubbing, and of solvent and reagents likely to be encountered in NORMAL USE Resistant also against agents specified by manufacturer for cleaning and decontamination procedure Test Report IEC/EN A Rev. 00 /

76 age 6 of 9 Report Reference No.: CSA Clause Requirement + Test Result - Remark Verdict 5.4 Documentation General Information about any RISKS not reduced to a TOLERABLE RISK level Information included in documentation on: Training; or rotective devices; or ersonal protective equipment to reduce RISKS to a TOLERABLE RISK level specified: Equipment transportation, installation and assembly instructions a) Documentation for the RESONSIBLE BODY includes: Instructions for transportation after delivery to the RESONSIBLE BODY b) Floor loading requirements c) Individual weights of principal heavy subassemblies d) Location and mounting instructions e) Assembly instructions f) Instructions for protective earthing g) The sound data required by h) Instructions relating to the handling, containment and exhaust of hazardous substances i) Any drainage systems required j) rotective measures relating to hazardous radiation k) Connections to the supply l) ERMANENTLY CONNECTED EQUIMENT only: 1) Mains supply requirements and details of connections 2) If external switch or circuit-breaker, requirements and location recommendation m) Special services including pressure limits Equipment operation Instructions for use include: 5.4.4a) Details of operating controls 5.4.4b) ositioning for disconnection 5.4.4c) Interconnection Test Report IEC/EN A Rev. 00 /

77 age 7 of 9 Report Reference No.: CSA Clause Requirement + Test Result - Remark Verdict 5.4.4d) Specification of intermittent operation limits 5.4.4e) Explanation of symbols used f) g) Any actions to be taken by an OERATOR in case of a malfunction Cleaning and decontamination (see 11.2) incl. materials h) Disposal of waste i) j) k) l) m) Hazardous substances, use, need for training, or personal protection measures Infectiouse substances, need to use protective gloves or other protective means Hazardous vapours, instructions for protection of the mouth, nose or eyes Hazardous radiation, instructions and requirements for protective devices A statement about protection impairment if used in a manner not specified by the manufacturer Self-test IVD medical equipment Instructions for use for self-test equipment comply with annex BB Removal of equipment from use for repair or disposal Instructions for the RESONSIBLE BODY for eliminating or reducing HAZARDS includes: Removal from use Transportation or disposal Requirements for minimizing biohazards Transport and storage ermissible environmental conditions for transport and storage specified: In documentation; and On outside of packaging 8 MECHANICAL RESISTANCE TO SHOCK AND IMACT Transport and storage Records of tests performed by the manufacturer show conformity (Guidance ASTM D4169 of ISTA) 11 ROTECTION AGAINST HAZARDS FROM FLUIDS (See test records attached) 11.3 Spillage Test Report IEC/EN A Rev. 00 /

78 age 8 of 9 Report Reference No.: CSA Clause Requirement + Test Result - Remark Verdict otentially aggressive substances (such as corrosive, toxic or flammable liquids) taken into account otentially aggressive substances compatible with contacted parts of the equipment 13 ROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXLOSION AND IMLOSION 13.1 oisonous and injurious gases and substances Attached data/test reports demonstrate conformity (in NC and SFC) Dangerous amounts of poisonous or injurious gases or substances not liberated in NORMAL CONDITION or in SINGLE FAULT CONDITION (see Form A.1) If potentially hazardous substances are liberated: OERATOR not be wetted nor able to inhale quantities likely to be hazardous rotective covers or similar means of protection 14 COMONENTS 14.3 Overtemperature protection devices 14.3 c) Does not operate in NORMAL USE Not self-resetting in self-test IVD equipment Annex AA RISK MANAGEMENT EN ISO applied Conformity demonstrated (see documents attached) GROU DEVIATIONS OF EN : Equipment operation Instructions for IVD medical equipment for commercial use comply with EN 591 Instructions for self-test IVD medical equipment use comply with EN 592 (see documents attached) (see documents attached) Self-test IVD medical equipment Clause deleted Test Report IEC/EN A Rev. 00 /

79 age 9 of 9 Report Reference No.: CSA TABLE: Summary of SINGLE FAULT CONDITIONS Form A.1 Subclause Title Does not apply ROTECTIVE IMEDANCE X Carried out rotective conductor X see Form A Equipment or parts for short-term or intermittent operation Motors X Capacitors X Mains transformers Attach drawing of MAINS Txs showing all protective devices (see Forms A.29 and A.30) Outputs X Equipment for more than one supply X Cooling X air holes closed X fans stopped X coolant stopped X Heating devices X timer overridden X temperature controller overridden X loss of cooling liquid X overfilled or empty or both X Insulation between circuits and parts X Interlocks X Incorrect voltage selection X List below all SINGLE FAULT CONDITIONS not covered by to : 13.1 oisonous and injurious gases and substances X X X Comments NOTE Record surface temperatures of flammable liquids and parts in contact with them in Form A.20A Supplementary information: (see Form A.2 for details of tests) Test Report IEC/EN A Rev. 00 /

80 age 1 of 3 TEST REORT IEC Safety requirements for electrical equipment for measurement, control, and laboratory use art 2-081: articular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes Report Reference No.... : Tested by (name and signature)... : Approved by (name and signature).. : CSZ Albert. Lee Harry. Kwon Date of issue... : Contents... : Modification Test Report Reference Number... : Modification to appliance... : 3 pages CSA Applicant address Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : as above CBTL [ x ] SMT [ ] TM [ ] Address... : as above Applicant s name... : Address... : Test specification: Boditech Med Inc. Standard... : IEC/EN Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : Geoduri, Dongnaemyeon, Chuncheon, Gangwon-do, , Republic of KOREA CE-LVD IEC61010_2_081A IMQ S.p.A. Master TRF... : Dated March 2002 Copyright 2002 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trademark... : Model/Type reference... : Rating(s)... : Blood and urine analyzer Boditech i-chroma 12 V d.c., 3.0 A Test Report IEC Rev. 00 /

81 age 2 of 3 Report No. CSZ IEC Test item particulars... : Type of item tested... : Blood and urine analyzer Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : II ollution degree... : 2 Environmental rating...: Standard Equipment mobility...: Movable Connection to mains supply...: Detachable cord set Operating conditions...: Continuous Overall size of the equipment (L x W x H)...: 250 mm X 185 mm X 80 mm Mass of the equipment (kg)...: 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : N.A Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator. Test Report IEC Rev. 00 /

82 age 3 of 3 Report No. CSZ IEC Copy of marking plate: Summary of test results (information/comments): - The presented unit was found to be in compliance with the standard of IEC/EN :2001, IEC/EN and IEC/EN Test Report IEC Rev. 00 /

83 age 1 of 20 TEST REORT IEC Safety requirements for electrical equipment for measurement, control, and laboratory use art 2-081: articular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes Report Reference No.... : Tested by (name and signature)... : CSA Edward.Yang Approved by (name and signature).. : Thomas. Kim Date of issue... : Contents... : 20 ages Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : as above CBTL [ x ] SMT [ ] TM [ ] Address... : as above Applicant s name... : Address... : Test specification: Boditech Med Inc. Standard... : IEC/EN Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : #3-2,Bioventure laza , HupyeongDong, Chuncheon, Kangwon, , Republic of Korea CE-LVD IEC61010_2_081A IMQ S.p.A. Master TRF... : Dated March 2002 Copyright 2002 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trademark... : Model/Type reference... : Rating(s)... : Blood and urine analyzer Boditech i-chroma 12 V d.c., 3.0 A Test Report IEC Rev. 00 /

84 Test item particulars... : age 2 of 20 Report No. CSA Type of item tested... : Blood and urine analyzer Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : II ollution degree... : 2 Environmental rating... : Standard Equipment mobility... : Movable Connection to mains supply... : Detachable cord set Operating conditions... : Continuous Overall size of the equipment (L x W x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : N.A Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : until General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator. Test Report IEC Rev. 00 /

85 age 3 of 20 Report No. CSA Copy of marking plate: Test Report IEC Rev. 00 /

86 Summary of test results (information/comments): age 4 of 20 Report No. CSA The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN i-chroma is basic model which was tested. - For test, AC/DC adaptor model MU50-105, manufacturerd by Sinpro electronics Co., Ltd. was used. Test Report IEC Rev. 00 /

87 age 5 of 20 Report No. CSA TABLE: 1 - Documents attached to this report Document No. Document description age Numbers Attachment 1 hotos 2 Test Report IEC Rev. 00 /

88 age 6 of 20 Report No. CSA TABLE: 2 - Test equipment list Item Type Equipment Calibration date Comments 1-A Temperature & Humidity Chamber 2-A Temperature Chamber No. Last 1 Due ER-35MHH ERH-432-2T A DC ower Supply DR305DN B Temperature Recorder 15-A Dielectric Strength Tester DR TOS A DC ma Meter A True RMS Multi- Meter 51-A IEC61032 Test robe B 55-A Drop Test Check Jig & Scale 59-A Hard Wood Surface B IT A Stop Watch HS B Isopropyl alcohol B ush-pull gauge DS-5K I IEC Fig.2C Test probe ) or interval between calibrations. Test Report IEC Rev. 00 /

89 age 7 of 20 Report No. CSA IEC Unique component reference or location (including drawing reference if required) TABLE: 3 - List of components and circuits relied on for safety Application/Function Manufacturer (NOTE 1) art number RATING (NOTE 2) AC/DC Adaptor - Sinpro electronics Co., Ltd. MU Input : V~, Hz, 1.35 A Output : 12 V d.c., 3.75 A Evidence of acceptance (NOTE 3) UL, TUV Rheinland ower switch - Zhongxun KCD V~, 3 A TUV Rheinland Motor - Saehan Electronics 4S42Q-T12034SD 12 V d.c. Tested with appliance Lithium battery(bt1) - anasonic CR V d.c. Max. abnormal charging current : 10 ma LCD panel - Shenzhen Topway Technology co.,ltd Laser diode in measuring module LMB164ACD 6 V d.c., 1.3 ma Tested with appliance - QSI Co., Ltd. QL63D - SEMKO Enclosure - BASF Corp. G-35 Min.thickness 2.5 mm, HB UL UL CB - EUNSUNG ELECCOM.CO.LTD 1, 2 94V-0, 105, Min. thickness 1.6 mm UL Test Report IEC Rev. 00 /

90 age 8 of 20 Report No. CSA IEC Unique component reference or location (including drawing reference if required) TABLE: 3 - List of components and circuits relied on for safety Application/Function Manufacturer (NOTE 1) NOTE 1 - List all manufacturers concerned. NOTE 2 - Electrical, mechanical, flammability, etc. NOTE 3 - Licence number, file number or other documentary evidence of acceptance art number RATING (NOTE 2) Evidence of acceptance (NOTE 3) Test Report IEC Rev. 00 /

91 age 9 of 20 Report No. CSA IEC MARKING AND DOCUMENTATION General Letter symbols (IEC 60027) used Graphic symbols (IEC : Table 1) used No biohazard If other additional symbols are required, it shall not be possible to confuse them with the international symbols There are no colour requirements for symbols except for symbol 101 (see Table 1 ). Graphic symbols shall be explained in the documentation Terminals, connections and operating devices Gas and liquid connections a) b) The equipment shall be clearly marked near to the connector on the equipment with: a means of identifying the gas or liquid to be used. Where no internationally recognized symbol (including chemical formulae) exists, the equipment shall be marked with symbol 14 of Table 1; the maximum permitted pressure; or symbol 14 of Table 1 (see 5.4.3). 5.2 Warning markings Equipment that can be potentially infectious due to the samples or reagents used shall be prominently marked with symbol 101 of Table 1 Equipment that can be hazardous due to the use of chemical substances shall be marked with the appropriate symbol, or (if none is available) symbol 14 of Table 1. rotective covers shall be marked to warn the operator not to open or remove them except as permitted by or Any part of the equipment that contains biohazardous waste material which can be removed from the equipment during normal use shall be marked with symbol 101 of Table 1. Other warning markings are specified in c), b), Q), 6.6.2, 7.2 c), f), c), 7.3, 10.1, None of gas and liquid connections No biohazard No bio hazardous material Test Report IEC Rev. 00 /

92 age 10 of 20 Report No. CSA IEC Durability of markings Markings required by to 5.2 shall be permanently affixed and shall remain clear and legible under conditions of normal use, and resist the effects of temperature and rubbing, and of solvent and reagents likely to be encountered in normal use, including cleaning and decontaminating agents specified by the manufacturer. 5.4 Documentation General Information shall be given about any risks not reduced to a tolerable risk level by the protective measures specified in this standard. If there is a need for training or for the use of additional protective devices or personal protective equipment to reduce risks to a tolerable risk level, these shall be specified Equipment transportation, installation and assembly instruction 5.4.3a) Documentation for the responsible body shall include the following as applicable: instructions for transportation after delivery to the responsible body; (see Form A.4) 5.4.3b) floor loading requirements; 5.4.3c) individual weights of principal heavy sub-assemblies; None of heavy subassemblies 5.4.3d) location and mounting instructions, including the space required for ventilation, and for safe and efficient operator maintenance; 5.4.3e) assembly instructions; 5.4.3f) instructions for protective earthing; 5.4.3g) the sound data required by ; No sound level 5.4.3h) 5.4.3i) 5.4.3j) instructions relating to the handling, containment and exhaust of hazardous substances, including any requirements for preventing back-syphonage; any drainage systems required where a hazard could occur from the discharge of biological and chemical substances and hot fluids; details of protective measures relating to hazardous radiation (see clause.12); No hazardous substances No drainage systems No hazardous radiation 5.4.3k) instructions for connections to the supply 5.4.3l) for permanently connected equipment only: Test Report IEC Rev. 00 /

93 age 11 of 20 Report No. CSA IEC m) 1) mains supply requirements and details of connections, including the rated temperature of the cable required at maximum rated ambient temperature; 2) requirements for any external switches, circuitbreakers (see ) or overcurrent protection devices (see 9.5). A recommendation that a switch or circuit breaker be near the equipment shall also be included if this is necessary for safety; requirements far special services (far example air, cooling liquid) including pressure limits Equipment operation 5.4.4a) 5.4.4b) 5.4.4c) Instructions for use include: details of operating controls and their use in all operating modes with any sequence of operation an instruction not to position the equipment so that it is difficult to operate the disconnecting device (see 6.11 ); instructions for interconnections to accessories and other equipment, including details of suitable accessories, detachable parts and any special materials; 5.4.4d) limits for intermittent operation; Continuous operation 5.4.4e) 5.4.4f) 5.4.4g) an explanation of symbols used on the equipment and, where hazards are involved, the reason for using a symbol in each particular case; Instructions for any actions to be taken by an operator in case of a malfunction; instructions and recommendations for cleaning and decontamination, with materials recommended (see 11.2); 5.4.4h) instructions for the disposal of waste; 5.4.4i) 5.4.4j) 5.4.4k) if normal use involves the handling of hazardous substances, instructions on correct use and any need for training or personal protection measures; if there could be contact with the skin when handling potentially infectious substances (such as human samples or reagents), the need to use protective gloves; if the equipment could emit hazardous aerosol vapours in normal use, instructions for protection of the mouth, nose or eyes; No hazardous substances No potentially infectious substances No hazardous aerosol Test Report IEC Rev. 00 /

94 age 12 of 20 Report No. CSA IEC l) 5.4.4m) if potentially hazardous visible or invisible radiation could be emitted, instructions and requirements for protective devices, such as protective glasses; Instructions relating to access to moving parts (see and ) Instructions shall be provided for the responsible body for eliminating or reducing hazards involved in removal from use, transportation or disposal. These instructions shall include requirements for minimizing biohazards. 7 ROTECTION AGAINST MECHANICAL HAZARDS Accessibility during normal use No accessibility during normal use If moving parts are unavoidably exposed in normal use, risk management (see annex AA) shall be carried out to establish whether the moving parts could cause injury to the operator. Any risks shall be minimized as far as practicable by protective measures, in the following order of priority: a) protective devices (interlock systems or other means, removable only with a tool); b) protective covers; c) mechanical barriers; d) sufficient distance between safe areas and moving parts e) warning signals (audible or visible); f) warning markings (see 5.2). If moving parts are unavoidably exposed during normal use, the instructions shall specify that procedures which could result in injury are carried out only by operators who have been warned of the potential hazards and have received adequate training in carrying out the procedures in the safest possible manner Accessibility outside normal use If an operator carrying out routine maintenance outside normal use has to perform a procedure, which requires access to hazardous moving parts, access is permitted provided that all of the following precautions have been taken: Test Report IEC Rev. 00 /

95 age 13 of 20 Report No. CSA IEC a) access to moving parts protected by devices specified in a) is not possible without the use of a tool b) the instructions for the responsible body include a statement that operators must be trained before being allowed to perform the hazardous procedure; c) there are warning markings (see 5.2) on any covers or parts which have to be removed to obtain access and the warning prohibits access by untrained operators As an alternative, symbol 14 of Table 1 shall be placed on the covers or parts and the warnings included in the documentation. 8 MECHANICAL RESISTANCE TO SHOCK AND IMACT After the tests of and 8.2.1: Voltage tests (see Form A.14) Inspections: 8 a) HAZARDOUS LIVE parts not accessible No hazardous live parts 8 b) ENCLOSURE shows no cracks (hazard) 8 c) CLEARANCES not less than their permitted values (see Form A.13) 8 d) BARRIERS not damaged or loosened 8 e) No moving parts exposed, except permitted by f) No damage which could cause spread of fire 11 ROTECTION AGAINST HAZARDS FROM FLUIDS 11.3 Spillage (See Form A.23) If in normal use, liquid is likely to be spilled into the equipment, the equipment shall be designed so that no hazard will occur, as a result of the wetting of insulation or of internal uninsulated parts which are hazardous live, or as a result of the contact of potentially aggressive substances (such as corrosive, toxic or flammable liquids) with parts of the equipment. 13 ROTECTION AGAINST LIBERATED GASES AND SUBSTANCES, EXLOSION AND IMLOSION 13.1 oisonous and injurious gases and substances No such gases and substances Test Report IEC Rev. 00 /

96 age 14 of 20 Report No. CSA IEC Equipment shall not liberate dangerous amounts of poisonous or injurious gases or substances in normal condition or in single fault condition. If potentially hazardous substances are liberated, the operator shall not be wetted nor be able to inhale quantities likely to be hazardous. The areas of the equipment containing such substances shall be equipped with protective covers or similar means of protection. Test Report IEC Rev. 00 /

97 age 15 of 20 Report No. CSA IEC TABLE: Durability of markings Form A.4 Marking method (see NOTE) Agent 1) rinted on label, fixed by adhesive on enclosure A Water 2) Silk-screened on parts B Isopropyl alcohol 3) C (specify agent) 4) D (specify agent) 5) E (specify agent) NOTE Where applicable include print method, label material, ink or paint type, fixing method, adhesive and surface to which marking is fixed. Marking location Identification (5.1.2) 1) Mains supply (5.1.3) 1) Fuses (5.1.4) 1) TERMINALS and operating devices ( ) Measuring circuit TERMINALS ( ) Switches and cricuit breakers (5.1.6) 2) DOUBLE/REINFORCED equipment (5.1.7) Field wiring TERMINAL boxes (5.1.8) Warning marking (5.2) 1) Battery charging (13.2.2) Marking method (see above) Method Test agent Remains legible Label loose Curled edges Comments Rubbed by cloth Isopropyl alcohol Verdict Verdict Verdict Yes No No ass Test Report IEC Rev. 00 /

98 age 16 of 20 Report No. CSA IEC TABLE: CLEARANCES and CREEAGE DISTANCES Form A.13 8 Mechanical resistance to shock and impact Integrity of CLEARANCES and CREEAGE DISTANCES Location (see Form A.5) A (Reinforced insulation) Measured Test at Measured after test Verdict Mechanical tests (note) Verdict (initial 6.7) max. (if required) CREEAGE CLEARANCE Applied Rigidity Drop RATED CREEAGE CLEARANCE Comments DISTANCE force (8.1) (8.2) ambient DISTANCE mm mm (6.7) N Static Dynamic Normal Hand-held/ (10.5.1) mm mm lug-in N 5 J Corne r drop With EN certified AC/DC adaptor. NOTE Refer to Form A.12 for dielectric strength tests following the above tests. Test Report IEC Rev. 00 /

99 age 17 of 20 Report No. CSA IEC TABLE: Dielectric strength tests Form A b) Conformity after application of fault conditions rotection in NORMAL CONDITION DOUBLE INSULATION and REINFORCED INSULATION Connections to external circuits c) CLEARANCE values General: reduced CLEARANCES for homogeneous construction Fitting of non-detachable MAINS SULY cords 1 8 Mechanical resistance to shock and impact 9.1 a) 2) Eliminating or reducing the sources of ignition within the equipment 9.3 c) Limited-energy circuit 11.2 Cleaning Spillage Overflow Specially protected equipment 1 1 Record the fault, test or treatment applied before the dielectric strength test Location or references from Forms A.2 and A.5 Test site altitude... : < 250 m Test voltage correction factor (see Table 10)... : Clause or sub-clause Humidity Yes/No Working voltage V Test voltage r.m.s./peak/d.c V Comments A, Sample #1-1/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ b) No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/3 6.4 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/ No 240 Vrms 2224 Vrms No breakdown A, Sample #1-1/3 8 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-2/3 8 No 240 Vrms 2224 Vrms No breakdown A, Sample #1-3/3 8 No 240 Vrms 2224 Vrms No breakdown Verdict Test Report IEC Rev. 00 /

100 age 18 of 20 Report No. CSA IEC Supplementary information: Test Report IEC Rev. 00 /

101 age 19 of 20 Report No. CSA IEC TABLE: Mechanical resistance to shock and impact Form A rotection against hazards from fluids Voltage tests can be carried out once after performing the tests of clause 8 and clause 11. However, if voltage tests are carried out separately after each set of tests, two forms can be used. Clause 8 tests Clause 11 tests Location (see form A.5) Static Dynamic Normal Handheld lug-in Cleaning (11.2) Spillage (11.3) Overflow (11.4) IEC (11.6) Working voltage V Test voltage V Verdict Comments A 30 N 5J Corner drop Isopropyl alcohol With certified AC/DC adaptor NOTE Use r.m.s., d.c. or peak to indicate the used test voltage. Test Report IEC Rev. 00 /

102 age 20 of 20 Report No. CSA IEC Remarks Test Report IEC Rev. 00 /

103 Attachment - age 1 of 2 Report Reference No. CSA

104 Attachment - age 2 of 2 Report Reference No. CSA

105 age 1 of 5 Report Reference No.... : Tested by (name and signature)... : Approved by (name and signature).. : TEST REORT IEC / EN Safety requirements for electrical equipment for measurement, control, and laboratory use art 1: General requirements CSA M1 Edward.Yang Thomas.Kim Date of issue... : Contents... : Modification Test Report Reference Number... : Modification to appliance... : 5 ages CSA Modification on clause... : Clause 12.1, 12.6, Table 3 ages concerned... : 7, 24, 25 Testing Laboratory... : Correction for list of components and circuits relied on for safety TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : Address... : Applicant s name... : Address... : Test specification: Standard... : Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : CE-LVD Same as above Boditech Med Inc. #3-2,Bioventure laza , HupyeongDong, Chuncheon, Kangwon, , Republic of Korea EN : 2001 (2 nd Edition) CE-LVD IEC61010_C VDE Master TRF... : Dated Copyright 2001 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trademark... : Model/Type reference... : Rating(s)... : Blood and urine analyzer Boditech i-chroma 12 V d.c., 3.0 A

106 age 2 of 5 Report Reference No. CSA M1 Test item particulars... : Blood and urine analyzer Type of item tested... : Laboratory (IVD equipment) Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : ollution degree... : 2 Environmental rating... : Normal Equipment mobility... : Movable Connection to mains supply... : Operating conditions... : Continuous Overall size of the equipment (L x W x H)... : 250 mm X 185 mm X 80 mm Mass of the equipment (kg)... : 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator.

107 age 3 of 5 Report Reference No. CSA M1 Copy of marking plate: Summary of test results (information/comments): ass - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN i-chroma is basic model which was tested. - For test, AC/DC adaptor model MU50-105, manufactured by Sinpro electronics Co., Ltd. was used. - This test report is amended from report No CSA because of correction for list of components and circuits relied on for safety.

108 age 4 of 5 Report Reference No. CSA M1 TABLE: 3 - List of components and circuits relied on for safety Unique component reference or location (including drawing reference if required) Application/Function Manufacturer (NOTE 1) AC/DC Adaptor - Sinpro electronics Co., Ltd. art number RATING (NOTE 2) MU Input : V~, Hz, 1.35 A Output : 12 V d.c., 3.75 A Evidence of acceptance (NOTE 3) UL, TUV Rheinland ower switch - Zhongxun KCD V~, 3 A TUV Rheinland Motor - Saehan Electronics 4S42Q-T12034SD 12 V d.c. Tested with appliance Lithium battery(bt1) - anasonic CR V d.c. Max. abnormal charging current : 10 ma LCD panel - Shenzhen Topway Technology co.,ltd Laser module for measuring LMB164ACD 6 V d.c., 1.3 ma Tested with appliance - IEMBIO Laser_M 33 ma, Wavelength : 625 nm Enclosure - BASF Corp. G-35 Min.thickness 2.5 mm, HB UL UL KTL (IEC ) CB - EUNSUNG ELECCOM.CO.LTD 1, 2 94V-0, 105, Min. thickness 1.6 mm UL NOTE 1 - List all manufacturers concerned. NOTE 2 - Electrical, mechanical, flammability, etc. NOTE 3 - Licence number, file number or other documentary evidence of acceptance NOTE 4 Bold is for correction.

109 age 5 of 5 Report Reference No. CSA M1 12 ROTECTION AGAINST RADIATION, INCLUDING LASER SOURCES, AND AGAINST SONIC AND ULTRASONIC RESSURE 12.1 General Equipment provides protection 12.6 Laser sources (IEC )

110 age 1 of 6 TEST REORT IEC Safety requirements for electrical equipment for measurement, control, and laboratory use art 2-081: articular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes Report Reference No.... : Tested by (name and signature)... : CSA M1 Edward.Yang Approved by (name and signature).. : Thomas. Kim Date of issue... : Contents... : Modification Test Report Reference Number... : Modification to appliance... : 6 ages Modification on clause... : Table 3 ages concerned... : 7, 8 CSA Correction for list of components and circuits relied on for safety Testing Laboratory... : TÜ V SÜ D Korea Laboratory (TKL) Address... : #315 and 316, MARIO Tower, , Guro-Dong, Guro-Gu, , Seoul, Korea Testing location/procedure... : as above CBTL [ x ] SMT [ ] TM [ ] Address... : as above Applicant s name... : Address... : Test specification: Boditech Med Inc. Standard... : IEC/EN Test procedure... : Non-standard test method... : Test Report Form No.... : TRF Originator... : #3-2,Bioventure laza , HupyeongDong, Chuncheon, Kangwon, , Republic of Korea CE-LVD IEC61010_2_081A IMQ S.p.A. Master TRF... : Dated March 2002 Copyright 2002 IEC System for Conformity Testing and Certification of Electrical Equipment (IECEE), Geneva, Switzerland. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description... : Trademark... : Blood and urine analyzer Boditech

111 age 2 of 6 Report No. CSA M1 Model/Type reference... : Rating(s)... : i-chroma 12 V d.c., 3.0 A Test item particulars... : Type of item tested... : Blood and urine analyzer Description of equipment function... : Analyzing of blood and urine Installation/overvoltage category... : II ollution degree... : 2 Environmental rating...: Standard Equipment mobility...: Movable Connection to mains supply...: Detachable cord set Operating conditions...: Continuous Overall size of the equipment (L x W x H)...: 250 mm X 185 mm X 80 mm Mass of the equipment (kg)...: 1.2 kg Marked degree of protection to IEC : Accessories and detachable parts included in the evaluation... : N.A Options... : Test case verdicts: Test case does not apply to the test object... : Test object does meet the requirement... : (ass) Test object does not meet the requirement... : F(Fail) Testing... : Date of receipt of test item... : Date (s) of performance of tests... : General remarks: This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. This report shall not be reproduced, except in full, without the written approval of the issuing testing laboratory. The test results presented in this report relate only to the item(s) tested. "(see remark #)" refers to a remark appended to the report. "(see Annex #)" refers to an annex appended to the report. "(see Form A.#)" refers to a table appended to the report. Throughout this report a point is used as the decimal separator. Test Report IEC Rev. 00 /

112 age 3 of 6 Report No. CSA M1 Copy of marking plate: Summary of test results (information/comments): - The presented unit was found to be in compliance with the standard of IEC/EN :2001 and IEC/EN , IEC/EN i-chroma is basic model which was tested. - For test, AC/DC adaptor model MU50-105, manufactured by Sinpro electronics Co., Ltd. was used. - This test report is amended from report No CSA because of correction for list of components and circuits relied on for safety. Test Report IEC Rev. 00 /