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1. Clause Requirement Test Result Remark Verdict a Potential not more than 30 r m s and 42 4 V peak N A or 60 V dc b Current limited by one of following means N A 1 Inherently or by impedance see Table 17 or N A 2 Overcurrent protective device see Table 18 N A Or 3 Aregulating network limits also in SINGLE N A FAULT CONDITION see Table 17 C Is separated by at least BASIC INSULATION N A Fuse or a nonadjustable electromechanical device is N A used 9 5 Requirements for equipment containing or using No flammable liquid is N A flammable liquids provided Flammable liquids contained in or specified for use see Form A 20 N A with equipment do not cause spread of fire RISK is reduced to a tolerable level N A a temperature of surface or parts in contact with N A flammable liquids is 25 C below fire point b The quantity of liquid is limited N A c Flames are contained within the equipment N A Detailed instructions for RISK reduction provided N A 9 6 Overcurrent protection 9 6 1 MAINS supplied equipment protected In the power supply BASIC INSULATION between MAINS parts of opposite see Form A 14 polarity provided Devices not in the protective conductor Not be fitted in the protective P conductor Fuses or single pole circuit breakers not fitted in neutral Not fitted in Neutral P multi phase 9 6 2 PERMANENTLY CONNECTED EQUIPMENT Not a p
2. Clause Requirement Test Result Remark Verdict a product of pressure and volume gt 200 kPal and N A b pressure gt 50 kPa N A Parts of refrigerating systems meets pressure related No refrigeration N A requirements of IEC 60335 24 or IEC 60335 24 11 7 3 Leakage from low pressure parts see Form A 25 N A 11 7 4 Overpressure safety device No overpressure safety N A device Does not operate in NORMAL USE N A a Connected as close as possible to parts intended N A to be protected b Easy access for inspection maintenance and N A repair c Adjustment only with TOOL N A d discharge towards person N A e No HAZARD from deposit of discharged material N A f Adequate discharge capacity N A No shut off valve between overpressure safety device N A and protected parts 12 PROTECTION AGAINST RADIATION INCLUDING N A LASER SOURCES AND AGAINST SONIC AND ULTRASONIC PRESSURE 12 1 Equipment provides protection N A 12 2 Equipment producing ionizing radiation N A 12 2 1 lonizing radiation see Form A 26 N A 12 2 1 1 Equipment meets the following requirements Not producing ionizing N A radiation a if intended to emit radiation meets requirements of N A 12 2 1 2 or tested classified and marked in accordance to IEC N A 60405 b if only emits stray radiation meets requirements of N A 12 2 1 3 12 2 1 2 Equipment intended to emit radiation No ionizing radiation N A Effecti
3. NA Non standard test method NA Test Report Form No EN61010_1F Test Report Form s Originator Cerpass Test item description Magnetic Immunoassay Analyzer M ee Mag u Model and or type reference XacPro S 110 230Vac 50 60Hz 500W Class Same as Applicant T1402142 253 Page 2 of 69 O Test item particulars TYDS Of iuste n eret rette Measurement GControl Laboratory Connection to MAINS supply Bermanent Detachable cord set Non detachable cord set None Direct plug in Installation category eene POLLUTION DEGREE I asss 2 Protection ClaSS u d etit Class Environmental Standard Extended Specity Equipment mobility Portable Hand held Floor standing Fixed Builtin Operating conditions Continuous Shert time Intermittent Marked degree of protection to IEC 60529 Ordinary Possible test case verdicts Test case does not apply to the test object N A Not Applicable Test object does meet the requirement P Pass Test object does not meet the requirement F Fail TOSUNG wi
4. 4 Intrinsically protected and correctly mounted N A ENCLOSURE provides protection N A If non intrinsically protected Screen not removable without TOOL N A If glass screen not in contact with surface of tube N A 14 COMPONENTS AND SUBASSEMBLIES 14 1 Where safety is involved components and Components used in subassemblies meet relevant requirements accordance with their specified ratings 14 2 Motors No motor is used N A 14 2 1 Motor temperatures N A Does not present a HAZARD when stopped or prevented see Form A 21 N A from starting or Protected by over temperature or thermal protection No such parts N A device conform with 14 3 14 2 2 Series excitation motors N A Connected direct to device if over speeding causes a N A HAZARD 14 3 Overtemperature protection devices Protected by approved unit N A Devices operating in a SINGLE FAULT CONDITION see Form A 29 N A a Reliable function is ensured N A b RATED to interrupt maximum current and voltage N A c Does not operate in NORMAL USE N A If self resetting device used to prevent a HAZARD N A protected part requires intervention before restarting 14 4 Fuse holders No operator replaceable N A fuse No access to HAZARDOUS LIVE parts N A 14 5 MAINS voltage selecting devices Setting voltage range before N A the factory Accidental change not possible N A 14 6 MAINS transformers tested outside equipment N A 14 7 Printed circuit boards P lt 11402142 25
5. E ua un T Qaqa q S S au mas au Sisi 6 1 2 OPERATION PROCEDURES OF THE EUT 1 3 DESCRIPTION OF WORST CASE EVALUATION 2 GENERAL INFORMATION OF TEST 7 2 1 SUMMARY OF TEST RESULI 7 2 2 PERFORMANCE CRITERIA OF IMMUNITY TEST e 7 2 3 TEST EQUIPMENT ue RQ u aS Su qS aaa uu qua qawawaq 8 3 CONDUCTED EMISSION TEST ww 10 3 1 LIMITS OF TERMINAL DISTURBANCE VOLTAGE 10 3 2 TEST SETUP iisssessescesiessesseccessvsscseccsaceveosescecsscsiseeves 10 3 3 ENVIRONMENTAL CONDITIONS m saps P SoHo Se Nee E m EUR 11 3 4 DESCRIPTION OF THE TEST all
6. Free Read Read Gan Result Result Limit Limit Margin Margin No MHz AV QP dB AV QP AV QP AV QP dBuV dBuV dBuV dBuV dBuV dBuV dB dB 1 0 410 50 496 55 242 10 059 60 554 65 300 66 000 79 000 5 446 13 700 2 0 540 43 578 54 513 10 065 53 643 64 578 60 000 73 000 6 357 8 422 3 0 698 40 470 50 535 10 073 50 543 60 608 60 000 73 000 9 457 12 392 4 1 212 34 709 51 404 10 109 44 818 61 513 60 000 73 000 15 182 11 487 5 1 383 36 684 51 005 10 125 46 809 61 130 60 000 73 000 13 191 11 870 6 2 225 35 468 44 731 10 190 45 658 54 921 60 000 73 000 14 342 18 079 N3E11 103R0454 018 Page 13 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA co M RI v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan 3 6 Photo during the test N3E11 103R0454 018 Page 14 of 45 BORO RRP G Precision Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan 4 Radiated Emission Test 4 1 Limits of terminal disturbance voltage TEL 886 4 2359 9009 FAX 886 4 2359 8847 www pmc org tw ioe bern Basic Port Frequency range 10m Limits 3m Limi
7. General remarks 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 Form A xx refers to a table appended to the report Throughout this report a comma or point is used as the decimal separator Copy of marking plate Mag u Magnetic Immunoassay Analyzer Model NO XacPro S Serial NO XacPro S 201403001 MQ Rating 110 230VAC 50 60Hz 500W M D 03 2014 MagQu Co Ltd http Awww magqu com MedNet GmbH Made in Taiwan Borkstra amp e 10 48163 M nster Germany lt 11402142 253 gt 3 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 4 4 Testing in SINGLE FAULT CONDITIONS P 4 4 1 Fault tests see Form A 1 and A 2 P 4 4 2 Application of SINGLE FAULT CONDITIONS P 4 4 2 1 SINGLE FAULT CONDITIONS not covered by 4 4 2 1 to see Form A 1 and A 2 4 4 2 14 4 4 2 2 PROTECTIVE IMPEDANCE No protective impedance N A 4 4 2 3 PROTECTIVE CONDUCTOR P 4 4 2 4 Equipment or parts for short term or intermittent Continuous operate N A operation 4 4 2 5 Motors see Form A 1 and A 2 P 4 4 2 6 Capacitors No motor
8. 20 6 1 TEST SPECIFICATION AND PERFORMANCE CRITERIA 5526 6 2 TESTiSETUP CERE 26 6 3 ENVIRONMENTAL CONDITIONS P M 1 27 6 4 DESCRIPTION OF THE TEST RIE E 27 6 5 TEST RESULT WA MAE AA SA KIKA ain 6 6 PHOTOS DURING THE TEST cscscssssssccessceccsscsscccscscscssscscssscsscssssessesccsnccssessessccsssssessscssscssscsssssssssessscsssesssessos 29 7 ELECTRICAL FAST TRANSIENT BURST IMMUNITY TEST A 30 7 1 TEST SPECIFICATION AND PERFORMANCE CRITERIA 30 7 2 TEST SETUP Hn sassa sassa SU 7 3 ENVIRONMENTAL CONDITIONS 31 7 4 DESCRIPTION OF THE TEST 31 7 5 b d oid Pr EE T 7 6 PHOTO DURING THE TEST RM RT 33 8 IMMUNITY TEST OF CONDUCTED DISTURBANCES INDUCED BY RADIO FREQUENCY FIELDS E EE DW AR E TE M 8 1 TEST SPECIFIC
9. NOTE No limit is specified at present but a limit of 110 dB above the reference pressure value of 20 is under consideration for applicable frequencies between 20 kHz and 100 kHz Supplementary information lt 11402142 253 gt Page 60 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE Batteries Battery type Battery ratings Single component failures Battery load and charging circuit diagram Battery manufacturer model catalogue No Reverse polarity instalment test Supplementary information No battery is used Form A 28 Verdict 14 1 TABLE components P object part No manufac type model technical data mark s of turer trademark conformity PCB Interchangeable Interchangeable 105 C 0 UL Power inlet Interchangeable Interchangeable 250V 10A VDE Breaker Schneider EZC100F3015A 15A 3KA TUV UL Power supply DEUTRONIC DTPN25N 100 240V 60 50Hz 0 6 TUV_GS 0 3A O P 15Vdc 0 9A Power supply by PC Interchangeable Interchangeable 100 240V 50 60Hz 350W TUV UL Relay Interchangeable Interchangeable 5Vdc 1A UL N2 Nitrogen Liquid Interchangeable Interchangeable 5 liter lt 71402142 253 gt Page 61 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 43
10. 61010 2 101 a manufacturer s name or trade mark and the address The address shall include at least the city and country Mag u b model number name or other means of identifying the equipment See page 1 c where this is required by regulation the name and address of the authorized representative of the manufacturer EN 61010 2 101 The following additional information shall be marked on the equipment or packaging or in the instructions for use EN 61010 2 101 1 the serial number for example SN XXXX or alternatively the batch code preceded by LOT using symbol 102 of Table 1 EN 61010 2 101 SN No is marked 2 the following information EN 61010 2 101 i a clear indication that the equipment is IVD medical equipment EN 61010 2 101 Marked on the label ii if applicable a clear indication that the equipment is self test IVD medical equipment EN 61010 2 101 Not a self test IVD N A iii if a potential RISK is posed the identification of detachable components by manufacturer and part identification and where appropriate the batch code etc EN 61010 2 101 Stated in the manual iv any expiry date of consumable parts expressed as the year the month and where relevant the day in that order EN 61010 2 101 N A MAINS supply Equipment is marked as follows a Nature of supply 1 a c RATED MAINS frequency or ra
11. Device complies with all of For the fuse a RATED to limit the current or voltage to the level of 6 3 2 see Form A 8 b RATED for the maximum working voltage and RATED for the maximum operational current if applicable lt 11402142 253 gt 18 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict CLEARANCE CREEPAGE DISTANCE between see Form A 13 P terminations of the impedance meet requirements lied with i lati of SUPPLEMENTARY INSULATION of 6 7 a 6 6 Connections to external circuits 6 6 1 Connections do not cause ACCESSIBLE parts of the following to become HAZARDOUS LIVE in NORMAL CONDITION or SINGLE FAULT CONDITION the external circuits the equipment Protection achieved by separation of circuits or short circuit of separation does not cause a HAZARD N A Instructions or markings for each terminal include P a RATED conditions for TERMINAL P b Required RATING of external circuit INSULATION N A 6 6 2 TERMINALS for external circuits No terminals which are N A hazardous live TERMINALS which receive a charge from an internal see Form A 7 N A capacitor are not HAZARDOUS LIVE after 10 s of interrupting supply connection 6 6 3 Circuits with terminals which are HAZARDOUS LIVE No terminals which are N A hazardous live These circuits
12. NOTE Within 10 minutes of the end of treatment suitable tests in acc to 8 2 and 8 3 must be conducted and pass criteria of 8 1 Supplementary information 10 5 31 Ball pressure test Max allowed impression diameter 2 mm 10 5 3 Insulating Materials Form A 23 Part Test temperature Impression Diameter Verdict C mm Supplementary information 10 5 3 2 softening test ISO 306 N A Part Vicat softening temperature Thickness of sample Verdict mm Supplementary information lt 11402142 253 gt Page 57 of 69 EN 61010 1 EN 61010 2 101 Requirement Test Result Remark Verdict Form 24 Clause TABLE Mechanical resistance to shock and impact 11 Protection against HAZARDS from fluids Clause 8 tests Clause 11 tests Location Impact Normal Handheld Cleaning Spillage Overflow Working Test Verdict Comments see form A 5 8 2 2 8 3 1 Plug in 11 2 11 3 11 4 voltage voltage V V TOP Pass Pass Pass 230V 3480V P Plastic parts Enclosure Side Pass Pass Pass 230V 3480V P Plastic parts Enclosure Rear Pass Pass Pass 230V 3480V P Plastic parts Enclosure Front Pass Pass Pass 230V 3480V P Plastic parts Enclosure NOTE Use r m s d c or peak to indicate the used test voltage Supplementary information lt 71402142 253 gt Page 58 of 69
13. lt 71402142 253 gt 55 of 69 D EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 10 TABLE Temperature Measurements Form A 21A 10 1 Surface temperature limits NORMAL CONDITION and or SINGLE FAULT CONDITION 10 2 Temperature of windings NORMAL CONDITION and or SINGLE FAULT CONDITION 10 3 Other temperature measurements Operating conditions Max setting 60 60 Hz Test room ambient temperature ta 21 8 20 7 C 99 253 V duration 3 h Part Location Verdict Top enclosure of Multifunction synthesizer WF1944B Inner of Multifunction synthesizer WF1944B Power supply rear Controller Relay 5Vdc Enclosure outer Supplementary information lt 71402142 253 gt Page 56 of 69 D EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 10 5 2 TABLE Resistance to heat of non metallic ENCLOSURES Form A 22 EM Non operative 1 j Empty ENCLOSURE cn qo Operative treatment o Temperature during tests ENCLOSURE samples tested were All set Description Comments Verdict Whole set No deform or discolour P
14. Coil 198 5 mm 32 2 mm in length oi Excitation coil 2 Actual Specification I 198 5 mm 26 2 mm in length test Pick up coil 8 541 mm 6 1 mm in length No collision damage distortion or other Specification Visual adverse circumstances SQUID Input voltage 110 230V Actual Specification Power 72 118dBm WA es Frequency 405 710MHz No collision damage distortion or other Exterior Visual adverse circumstances A Input voltage 100 230V 60Hz Electronics AC Output voltage 0 20V Actual Specification AC Output frequency 0 1MHz test DC Output 5 0 5V No collision damage distortion or other Actual Exterior ET adverse circumstances test Shielding Shielding Factor 60 dB and shell S E Visual Specification Aluminum or other magnetic restraining materials Visual 10 The details for inspecting the standards of materials used are clearly illustrated in MQ WIQ 08 Quality Management System following ISO 13485 and ISO9001 3 3 Manufacturing Processes Follow the five steps to manufacture XacPro S Manufacturing shielding barrel Use u Metal copper mesh carbon fiber or aluminum as the basic materials to produce shielding barrels with shielding factor better than 60 dB Cooling down the SQUID Lower down the temperature of the SQUID magnetometer to 78K by liquid nitrogen and place them into shielding barrels Manufacturing coils Round copper wire to the coils
15. Manufacturing Electronics Build function generating system and data acquiring system QC and packaging The SNR should be better than 10 and the CV value should be better than 10 After QC pass and labeling surround the device by cushion material and wood box if necessary The manual should be also put into the cushion material or wood box All the details about manufacture QC and packing are regulated in MQ WIM 08 MQ WIM 08 01 02 03 05 Quality Management System following ISO 13485 and ISO9001 3 4 Software Information The software may be upgrade with time Therefore the version of the software should be memorized in the software list before packaging Further the serial number of product should also involve the version of software For ensuring the software of product is working every single product should do the sample test between QC and labeling The sample is Tau protein IMR reagents MF TAU 0060 made by MagQu Co Ltd With Tau antigen provide by MagQu Co Ltd The IMR signal from the software should be higher than 5 96 After sample test the serial number on the labeling will be attached two more numbers for software version before which are the last two numbers of serial number for better traceability 11 3 5 Packing List Packing materials Quantity XacPro S 1 set Operating and maintaining manual 1 set Labeling 1 set 12 4 Essential Requirement of the Medical Device Directive Check L
16. Remark Verdict 2 moulded and potted parts requirements of N A 6 7 3 4 2 3 inner layers of printed wiring boards requirements N A of 6 7 3 4 3 4 thin film insulation requirements of 6 7 3 4 4 N A 6 7 3 4 2 Moulded and potted parts N A Conductors between same two layers are separated by N A applicable distances of Table 8 6 7 3 4 3 Inner insulation layers of printed wiring boards N A Separated by at least by applicable distances of Table 8 N A between same two layers REINFORCED INSULATION have adequate electric N A strength one of following methods used a thickness at least applicable distance of Table 8 N A b insulation is assembled of minimum two separate N A layers each RATED for test voltage of Table 6 for BASIC INSULATION c insulation is assembled of min two separate layers N A where the combination is rated for 1 6 times the test voltage of Table 6 6 7 3 4 4 Thin film insulation N A Conductors between same two layers are separated by N A applicable CLEARANCES and CREEPAGE DISTANCES REINFORCED INSULATION have adequate electric N A strength one of following methods used a thickness at least applicable distance of Table 8 N A b insulation is assembled of min two separate layers N A each RATED for test voltage of Table 6 for BASIC INSULATION c insulation is assembled of min three separate see Form A 14 N A layers where the combination of two layers passed voltage tests with 1 6 time values of Table 6 a c test of 6 8 3
17. Verdict 5 4 4 Equipment operation The user s manual provided with the relevant statements Instructions for use include a details of operating controls and their use in all operating modes with any sequence of operation EN 61010 2 101 b an instruction not to position the equipment so that it is difficult to operate the disconnecting device see 6 12 EN 61010 2 101 c instructions for interconnections to accessories and other equipment including details of suitable accessories detachable parts and any special materials EN 61010 2 101 d limits for intermittent operation EN 61010 2 101 Continuous operation N A e an explanation of symbols used on the equipment and where HAZARDS are involved the reason for using a symbol in each particular case EN 61010 2 101 f instructions for any actions to be taken by an OPERATOR in case of a malfunction EN 61010 2 101 Trouble shooting is provided in the manual g instructions and recommendations for cleaning and decontamination with materials recommended see 11 2 EN 61010 2 101 Stated in the manual h instructions for the disposal of waste EN 61010 2 101 i if NORMAL USE involves the handling of hazardous substances instructions on correct use and any need for training or personal protection measures EN 61010 2 101 Stated in the manual j if there could be contact with the skin whe
18. XacPro S ver 201411 Description The measurement monitoring and display scale must be designed in line with ergonomic principles taking account of the intended purpose of the device The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80 18 1 EEC Protection against radiation General Devices shall be designed and manufactured in such a way that exposure of patients users and other persons to radiation shall be re duced as far as possible compatible with the intended purpose whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 EN62304 2006 EN62304 2006 26 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 Product Master file No MF07 Product user Manual XacPro S ver 201411 Product Master file No MF07 The device is a low voltage device and never generates high energy radiation Clause Description Appli ca Standard Sub clause s Intended radiation Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is con sidered to outweigh the risks inherent in the emission it must be possible for the user to co
19. 360 versus the A C line phase angle and steps is 90 2 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 3 The test was repeated when the EUT was in idle standby state 9 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfully N3E11 103R0454 018 Page 39 of 45 E ik Ez gt TEL 886 4 2359 9009 P4 M b RH B BRIT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan RESULTS OF SURGE TEST Severity Requirement Performance Criteria Level Test Result Coupling AC AC AC AC Mode Line Line Line PE Line Line Line PE 0 5kV B A 1 0kV B A 2 0kV Note N R means no requirement B means monitor flash N3E11 103R0454 018 Page 40 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA co M RI v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center YA No 27 37th Road Taichung Industrial Park Taichung Taiwan 9 6 Photo during the test N3E11 103R0454 018 Page 41 of 45 dk cnt gt TEL 886 4 2359 9009 P4 M b RH B BRIT F
20. 6 5 2 PROTECTIVE BONDING see Form A 9 A 10 and P A 11 6 5 2 1 ACCESSIBLE conductive parts may become Plastic encased N A HARZARDOUS LIVE in SINGLE FAULT CONDITION Bonded to the PROTECTIVE CONDUCTOR TERMINAL or N A Separated by conductive screen or barrier bonded to N A PROTECTIVE CONDUCTOR TERMINAL 6 5 2 2 Integrity of PROTECTIVE BONDING P lt 11402142 253 gt 15 of 69 EN 61010 1 EN 61010 2 101 O Clause Requirement Test Result Remark Verdict a PROTECTIVE BONDING consists of directly connected Protective bonding are direct P structural parts or discrete conductors or both and connected to structural parts withstands thermal and dynamic stresses b Soldered connections Power cord is used N A Independently secured against loosening Not used for other purposes c Screw connections are secured Connections are secured against loosening d PROTECTIVE BONDING not interrupted or No part of the equipment is P removable by the operator exempted as removable part carries MAINS SUPPLY INPUT N A connection e Any moveable PROTECTIVE BONDING connection No moveable PE N A specifically designed and meets 6 5 2 4 f No external metal braid of cables used No such cables is used N A not regarded as PROTECTIVE BONDING g IF MAINS SUPPLY PASSES THROUGH No mains passes through N A Means provided for passing protective
21. 9 3 Containment of the fire within the equipment should it The equipment meets one of P occur the following construction requirement a Energizing of the equipment is controlled by an No held switch is provided N A operator held switch b ENCLOSURE is conform with constructional See 9 3 1 P requirements of 9 3 1 and Requirements of 9 5 are met No flammable liquid is N A provided 9 3 1 Constructional requirements a Connectors and insulating material have flammability classification V 2 or better b Insulated wires and cables are flame retardant P VW 1 or equivalent c ENCLOSURE meets following requirements 1 Bottom and sides in arc of 5 see Figure 13 to No hazardous live parts in non limited circuits 9 4 meets area D of Figure 13 for the side opening i no openings or No bottom opening N A ii perforated as specified in Table 16 or N A iii metal screen with a mesh or N A iv baffles as specified in Figure 12 N A 2 Material of ENCLOSURE and any baffle or flame P barrier is made of Metal except magnesium or Plastic encased N A Non metallic materials have flammability Complied with V 1 for the P classification V 1 or better adapters 3 ENCLOSURE and any baffle or flame barrier have The enclosure have P adequate rigidity adequate rigidity 9 4 Limited energy circuit see Form A 19 N A Not evaluated to limited energy lt 11402142 253 gt 31 of 69 EN 61010 1 EN 61010 2 101
22. APR 2 4 204 GMP Certificate Name of Manufacturer MAGQU CO LTD Address of Manufacturer 3F No 12 Lane 538 Zhongzhen Rd Xindian Dist New Taipei City Taiwan R O C GMP Registration Number GMP1065 Expiry Date March 18 2017 Scope of Registration 1 Magnetic Immunoassay Analyzer 2 MagQu Carcinoembryonic Antigen CEA Magnetic Reagent Non sterile The above mentioned manufacturer has been inspected periodically by the Ministry of Health and Welfare and found to be in compliance with the medical device Good Manufacturing Practice GMP requirements based on ISO 13485 This certificate is hereby issued pursuant to Paragraph 3 Article 57 of the Pharmaceutical Affairs Act This certificate may not be used as a product license Signed by No0 5371 1 o Cig ag Director General y Food and Drug Administration for Wen Ta Chiu MD Ph D Minister Ministry of Health and Welfare Republic of China Taiwan 61
23. EN 55011 2009 EN 62304 2006 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 62304 2006 ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Risk Management Report No RM07 02 Product research file XacPro S ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 Risk Management Report No RM07 02 Product research file XacPro S Description Appli ca Standard Sub clause s ble or not YES Directive 98 79 EC ENISO13485 2012 The characteristics and performances referred to in Sections 1 2 and 3 No must not be adversely affected to such a degree that the clinical conditions and safety of the patients and where applicable of other persons are compromised during the lifetime of the device as indicated by the manufacturer when the device is subjected to the stresses YES Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 ES which can occur during normal conditions of use Y Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 ENISO623074 206 17 The devices must achieve the performances intended by the manufacturer and be designed manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 2 a as specified by the manufacturer The devices must be designed manufactured and packed in such a way that their characteristics and performances during their
24. TABLE Overtemperature protection devices Form A 29 N A Reliability test Component Type Verdict Comments NOTE NOTE NSR non self resetting 10 times NR non resetting 1 time SR self resetting 200 times Supplementary information lt 11402142 253 gt 62 of 69 EN 61010 1 EN 61010 2 101 Requirement Test Result Remark Verdict TABLE Transient overvoltage limiting devices Form A 30 NA Component Designation Overvoltage MAINS voltage Test voltage fmax Rupture Circuit breaker Category V rms Yes No tripped Comments NOTE im measured temperature 1 tm corrected tn t 40 C max RATED ambient max maximum permitted temperature Conformity is checked by applying 5 positive and 5 negative impulses with the applicable impulse withstand voltage spaced up to 1 min apart from a hybrid impulse generator see IEC 61180 1 Supplementary information T1402142 253 Page 63 of 69 J PHOTOS lt 11402142 253 gt PHOTOS Page 64 of 69 lt 71402142 253 gt Page 65 of 69 O PHOTOS lt 11402142 253 gt PHOTOS Page 66 of 69 QUID Elekt Channel 2 licher SQUID 1 u d Sensortechnil 4 Forschungszentum Ji IN lt 11402142 253 gt PHOTOS Page 67 of 69 J 7 lt 11402142 253 gt Page 68 of 69 PHOTOS exu dani 6 0 2
25. The test was repeated when the EUT was in idle standby state 6 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfully N3E11 103R0454 018 Page 27 of 45 E ik Ez gt TEL 886 4 2359 9009 P4 M b RH B BRIT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan EMS LOG SHEET OF RS TEST AMPLITUDE MODULATION Test Result P Performance Description Requirement Criteria Criteria BCI Transmitter AC Input Power Cable Control Panel PASS Note N R means no requirement N3E11 103R0454 018 Page 28 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA M RI ik A EA UR v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan 6 6 Photos during the test N3E11 103R0454 018 Page 29 of 45 gt LE cn EN TEL 886 4 2359 9009 2 NA 3 Bj 25 BRAT AER id S FAX 886 4 2350 8847 Precision Machinery Research amp Development Center A TRES UTE No 27 37th Road Taichung Industrial Park Taichung Taiwan 7 Electrical Fast Transient Burst Immunity Test 7 1 Test specification and performance criteria AC input
26. 1 or N A d c test of 6 8 3 2 for circuits stressed only by d c N A voltages 6 8 Procedure for dielectric strength tests see Form A 5 and A 14 6 9 Constructional requirements for protection against electric shock 6 9 1 If a failure could cause a HAZARD a Security of wiring connections b Screws securing removable covers lt 11402142 253 gt 23 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict c Accidental loosening P d CREEPAGE and CLEARANCES not reduced below the P values of basic insulation by loosening 6 9 2 Material not to be used for safety relevant insulation P Easily damaged materials not used No such material is used P Non impregnated hydroscopic materials not used Same as above P 6 9 3 Colour coding P Green and yellow insulation shall not be used except G Y wires are only used for P earthing or bonding a protective earth conductors P b protective bonding conductors P c potential equalization conductors No such terminal N A d functional earth conductors P 6 10 Connection to MAINS supply source and connections P between parts of equipment 6 10 1 MAINS supply cords Approved power cord is N A used RATED for maximum equipment current see 5 1 3c N A Cable complies with IEC 60227 or IEC 60245 N A Heat resistant if likely to contact
27. 3 5 RESULT A EIA A E wa N A NAA E EE T AA E E EE E I AEA EOS 11 3 6 PHOTO DURING THE TEST 4 RADIATED EMISSION TEST A 4 1 LIMITS OF TERMINAL DISTURBANCE VOLTAGE ecce 14 15 15 4 2 TEST SETUP ET M 15 4 3 ENVIRONMENTAL CONDITIONS 16 4 4 DESCRIPTION OF THE TEST 16 4 5 TEST RESULT RENE TETTE 16 4 6 PHOTOS DURI
28. Carried out v Does not Comments apply see Form A 2 No protective impedance Y see Form A 2 lt Continuous operate No motor Not multi phase No motor capacitor Approved power unit lt aja No output Single supply No such parts No filters No fan No coolant No cooling liquid No heating device Approved power unit No interlock No voltage selectors amp I SIS lt lt lt lt APRS lt 4 4 2 2 to 4 4 2 14 lt 11402142 253 gt 41 of 69 7 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict 4 4 TABLE Testing in SINGLE FAULT CONDITION Results Form A 2 P Test Fault Fault description Td 4 4 3 How was test terminated subclause NOTE Comments No 4 4 2 1 1 Wrong setting on functional knob 30min hazards occurred and no accessible conductive parts have become hazardous live 4 4 2 3 2 Open Protective conductor No hazards and no accessible voltage over the limit NOTE Td Test duration in hh mm ss Record dielectric strength test on Form A 14 and temperature tests on Form 21 Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION Supplementary information lt 71402142 253 gt 42 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 5 1 3c TABLE MAINS supply Form A 3 P Marked rat
29. EUT 3 3 er sote chai der Ferschungszentrum J N3E11 103R0454 018 Page 10 of 10 ATTACHMENT Parts List IM CERAM RRR Ps Precision Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C XacPro S Parts List TEL 886 4 2359 9009 FAX 886 4 2359 8847 www pmc org tw Manufacturer Part No Ter sr Type Model Technical Data Function generator NF WF1944B Input AC100 240V MAX 500VA SQUID sensor JSQ rf SQUID Magnetometer 77K SQUID controller JSQ rf SQUID Electronics Output 72dBm to 118dBm SQUID control panel 1150 Touch Panel Controller Input DC 15V Output MAX Vpp 20V PC OS Windows XP Input AC100 240V 350W DAQ system NI PCI 6221 BNC2110 Input 10V Coils MagQu 8channel Input Max AC 10V Switch circuit MagQu 8channel switch Input DC 5V Dewar MVE Lab5 5L 77K N3E11 103R0454 018 Page 1 of 1 Appendix D Certification of ISO 13485 2003 zom Rune Sd a oe ed eS a oe apb ee eee serie Certificate TW14 10079 The management system of MagQu Co Ltd No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan R O C has been assessed and certified as meeting the requirements of ISO 13485 2003 EN ISO 13485 2012 For the following activities Design and Manufacture of non sterile magnetic beads for bio assay separation and diagnosis Design and Ma
30. For none detachable power cord the impedance between protective conductor plug pin of MAINS cord and each ACCESSIBLE part shall not exceed 0 2 Ohm Supplementary information TABLE Bonding impedance of permanently connected equipment N A Test Voltage attained after 1 min Verdict ACCESSIBLE part under test current maximum 10 V Supplementary information Form A 11 TABLE Transformer PROTECIVE BONDING screen Test current Voltage attained Calculated resistance Verdict ACCESSIBLE part under test see NOTE after 1 min maximum 0 1 A maximum 10 V 6 5 2 6 NOTE Test current must be twice the value of the overcurrent protection means of the winding Test is specified in 6 5 2 6 a or b Supplementary information lt 11402142 253 gt 49 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE protective impedance Form A 12 N A A single component Component Location Measured Calculated Verdict Comments Working Current Power voltage dissipation V A A combination of components Component Location Comments NOTE A PROTECTIVE IMPEDANCE shall not be a single electronic device that employs electron conduction in a vacuum gas or semiconductor Supplementary information No Protective impedance lt 11402142 253 gt 50 of 69 EN 61010 1 EN 61010 2 101 Requirement
31. Frequency 1400 2000 3 V m Field 2000 2700 1 MHz V m EN 6100043 Note1 amp 2 A Amplitude Modulated Unmodulated rms 80 1KHZ Notel As testing did not carry out inside a shielded enclosure bulk current injection BCI was used in accordance with EN 61000 4 6 and ISO 11451 4 Note 2 Additionally the dual band 144 amp 440MHz transmitter is to be used for RS testing at the fixed frequency 6 2 Test setup Power Signal 6dB Amplifier Generator Attenuator EUT Transmitter N3E11 103R0454 018 Page 26 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 6 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 24 6 C 53 8 1012 mbar 6 4 Description of the test 1 During the test the frequency range was swept from 80 to 400MHz incrementally with 1 step size of each frequency The test signal was 80 amplitude modulated with 1 KHz sine wave 2 The dual band 144MHz amp 440MHz transmitter shall be placed in horizontal and vertical to EUT for testing 3 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 4
32. Test Result Remark Verdict 6 7 TABLE CLEARANCES and CREEPAGE distances Form A 13 P 6 4 2 ENCLOSURES and protective barriers 8 Mechanical resistance to shock and impact 6 4 4 Impedance 9 6 1 Overcurrent protection basic insulation between MAINS parts 6 5 4 Protective impedance 10 5 1 Integrity of CLEARANCES and CREEPAGE distances 6 5 6 Current or voltage limiting device Location Measured Verdict Mechanical tests note Test at Measured after test Verdict Comments initial 6 7 max if required see Form CREEPAGE CLEARANCE Applied Rigidity Drop RATED CREEPAGE CLEARANCE A 5 DISTANCE force 8 2 8 3 ambient DISTANCE mm mm J Static Normal Hand held 10 5 1 mm mm 8 2 1 8 3 1 Plug in Mains to gt 3 gt 1 5 P 5 Y Y 40 gt 3 gt 1 5 P accessible parts GND Mains to gt 6 gt 3 P 5 4 v 40 gt 6 gt 3 P Secondary NOTE Refer to Form A 14 for dielectric strength tests following the above tests Supplementary information lt 11402142 253 gt Page 51 of 69 O EN 61010 1 EN 61010 2 101 1 Record the fau It test or treatment applied before the dielectric strength test Humidity preconditioning required Clause Requirement Test Result Remark Verdict 6 8 TABLE Dielectric strength tests Form A 14 OP 4 4 4 1 b Conformity after application of SINGLE FAULT CONDITIONS 6 4 Primary mea
33. applicable see Form A 21A P a Value of 60 C of field wiring terminal box not No field wiring terminal box N A exceeded b Surface of flammable liquids and parts in contact No flammable liquid N A with this liquids c Surface of non metallic ENCLOSURES d Parts made of insulating material supporting parts connected to MAINS supply e Terminals carrying a current more than 0 5 A No such aprts N A 10 4 Conduct of temperature test P 10 4 1 Tests conducted under reference test conditions and see Form A 21A P manufacturer s instructions 10 4 2 Temperature measurement of heating equipment No heating element is N A provided Tests conducted in test corner see Form A 21A N A 10 4 3 Equipment intended for installation in a cabinet or wall Floor standing equipment N A Equipment built in as specified in installation see Form A 21A N A instructions Same as above lt 11402142 253 gt 33 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 10 5 Resistance to heat P 10 5 1 Integrity of CLEARANCE and CREEPAGE DISTANCES see Form 13 P 10 5 2 Non metallic ENCLOSURES see Form A 22 P Within 10 min after treatment Equipment subjected to suitable stresses of 8 2 and 8 3 No dielectric breakdown P complying with criteria of 8 1 10 5 3 Insulating material P a Parts supporti
34. are N A Not connected to ACCESSIBLE conductive parts or N A Connected to ACCESSIBLE conductive parts but are not N A MAINS circuits and have one TERMINAL contact at earth potential No ACCESSIBLE conductive parts are HAZARDOUS LIVE N A 6 6 4 ACCESSIBLE terminals for stranded conductors No such terminal N A No RISK of accidental contact because N A Located or shielded N A Self evident or marked whether or not connected to N A ACCESSIBLE conductive parts ACCESSIBLE TERMINALS will not work loose N A 6 7 Insulation requirements see Form A 5 P 6 7 1 The nature of insulation 6 7 1 1 Insulation between ACCESSIBLE parts or between Complied with insulation P separate circuits consist of CLEARANCES CREEPAGE requirement DISTANCES and solid insulation if provided as protection against a HAZARD 6 7 1 2 CLEARANCES P lt 11402142 253 gt Page 19 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Required CLEARANCES reflecting factors of 6 7 1 1 see Form A 5 P Equipment rated for operating altitude greater than Not over 2000m N A 2000 m correction factor of Table 3 of 61010 1 applied 6 7 1 3 CREEPAGE DISTANCES P Required CLEARANCES reflecting factors of 6 7 1 1 see Form A 5 P CTI material group reflected by requirements P CTI test performed P 6 7 1 4 Solid insulation P Required CLEARANCES reflecting factors
35. based on their clinical dementia rating CDR scores Subjects with MCI due to AD or AD were recruited from the memory clinic at the National Taiwan University Hospital Following routine tests at the memory clinic they received a comprehensive clinical checkup including a review of their history physical and neurological examinations laboratory tests and neuroimaging studies Subjects with AD fulfilled the NINCDSADRDA criteria for probable AD The AD subjects were further evaluated using the Hachinski ischemic scale and those with a score greater than 4 were excluded Following the Mayo clinic criteria any subject with deficits in any recall subtest of the Taiwan version of the Wechsler Memory Scale Third Edition a CDR score of 0 5 and consistently normal activities of daily living instrumental activities of daily living ADL IADL was diagnosed with MCI due to AD The control subjects were selected from healthy volunteers The volunteers were given a medical checklist of major systemic diseases operations hospitalizations Volunteers reporting uncontrolled medical conditions including heart failure recent myocardial infarction in the past 6 months malignancy in the past 2 years or poorly controlled diabetes HbAIC gt 8 5 were excluded Volunteers also received physical and neurological examinations and were scored on a short form Geriatric Depression Scale GDS S Those who had a GDS S 50 score greater than 9 were exclude
36. capacitor N A 4 4 2 7 MAINS transformers In the approved power unit N A 4 4 2 7 2 Short circuit Same as above N A 4 4 2 7 3 Overload Same as above N A 4 4 2 8 Outputs No outputs N A 4 4 2 9 Equipment for more than one supply Single supply N A 4 4 2 10 Cooling No fan N A 4 4 2 11 Heating devices No heating device N A 4 4 2 12 Insulation between circuits and parts In the approved power unit N A 4 4 2 13 Interlocks No interlock N A 4 4 2 14 Voltage selectors Setting voltage range before N A the factory 4 4 3 Duration of tests see Form A 1 and A 2 4 4 4 Conformity after application of fault conditions see Form A 1 A 2 A 8 A 14 4 4 2 101 Incorrect voltage selection Setting voltage range before N A EN 61010 2 101 ine taclony 5 MARKING AND DOCUMENTATION 5 1 1 General Required equipment markings are visible From the exterior or On the enclosure After removing a cover or N A Opening a door N A After removal from a rack or panel N A lt 11402142 253 gt 4 069 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict Required markings are not put on parts which can be removed by an OPERATOR EN 61010 2 101 Letter symbols IEC 60027 used EN 61010 2 101 Graphic symbols table 1 used EN 61010 2 101 Comply with Table 1 Identification EN 61010 2 101 Equipment shall as a minimum be marked with the following information
37. castor or support that supports greatest load Same as above N A removed from equipment 7 5 Provisions for lifting and carrying No such parts N A 7 5 1 Equipment more than 18 kg Has means for lifting or carrying or N A Directions in documentation P 7 5 2 Handles or grips No handle or grips N A Handles or grips withstand four times weight N A 7 5 8 Lifting devices and supporting parts No lifting device N A Rated for maximum load or N A tested with four times maximum static load N A 7 6 Wall mounting The equipment is not for N A wall mount Mounting brackets withstand four times weight N A 7 7 Expelled parts Equipment contains or limits the energy Complied with the test of 4 4 Protection not removable without the aid of a tool Tool is needed RESISTANCE TO MECHANICAL STRESSES 8 1 Equipment does not cause a HAZARD when subjected to mechanical stresses in NORMAL USE Normal protection level is 5 J Tested with 5J P Levels below 5 J but not less than 1 J are acceptable if Same as above N A all of following criteria are met a lower level justified by RISK assessment of N A manufacturer b equipment installed in its intended application is not N A easily touched c only occasional access during NORMAL USE N A lt 11402142 253 gt 28 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict d IK code in accordance to IEC 62262 marked or symbol 14 used wi
38. connection to MAINS P supply Plug pins which receive a charge from an internal see Form A 7 P The pin not is hazardous live 5s after disconnection of the supply Accessory MAINS socket outlets a Marking if accepts a standard MAINS plug No mains socket outlet N A see 5 1 3e b Input has a protective earth conductor if outlet has N A EARTH TERMINAL CONTACT 6 11 Disconnection from supply source 6 11 1 Disconnects all current carrying conductors 6 11 2 Exceptions The disconnecting means will disconnect all current carrying conductors 6 11 3 Requirements according to type of equipment P 6 11 3 1 PERMANENTLY CONNECTED EQUIPMENT and multi phase Non permanently connected N A equipment Employs switch or circuit breaker N A If switch or circuit breaker is not part of the equipment documentation requires a Switch or circuit breaker to be included in building N A installation b Suitable location easily reached N A c Marking as disconnecting for the equipment N A 6 11 3 2 Single phase cord connected equipment P lt 11402142 253 gt 25 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Equipment is provided with one of the following a Switch or circuit breaker N A b Appliance coupler disconnectable without tool N A c Separable plug without locking device 6 11 4 Disconnecting devices Electrically
39. devices other than those covered by e This indication may be included in the batch or serial number m where applicable method of sterilization 35 Report Document XacPro S ver 201411 Comments Clause Description Appli ca Standard Sub clause s ble or not If the intended purpose of the device is not obvious to the user the manufacturer must clearly state it on the label and in the instructions for use components must be identified where appropriate in terms of batches to allow all appropriate action to detect any potential risk posed by the devices and detachable components 1 Where appropriate the instructions for use must contain the following particulars a the details referred to in Section 13 3 with the exception of d and e b the performances referred to in Section 3 and any undesirable side effects c if the device must be installed with or connected to other medical devices or equipment in order to operate as required for it intended purpose sufficient details of its characteristics to Wherever reasonable and practicable the devices and detachable 13 4 13 5 3 6 identify the correct devices or equipment to use in order to obtain a safe combination d all the information needed to verify whether the device is properly installed and can operate correctly and safely plus details of the 36 Directive 98 79 EC ISO 13485 2012 EN 61010 1 2010 EN 61010 2 101
40. hot parts N A Temperature RATING cord and inlet N A Green yellow used only for connection to PROTECTIVE N A CONDUCTOR TERMINALS Detachable cords with IEC 60320 MAINS connectors Conform to IEC 60799 or N A Have the current RATING of the MAINS connector N A 6 10 2 Fitting of non detachable MAINS supply cords P 6 10 2 1 Cord entry P Inlet or bushing smoothly rounded or P Insulated cord guard protruding gt 5D P 6 10 2 2 Cord anchorage P Protective earth conductor is the last to take the strain P a Cordis not clamped by direct pressure from a P screw b Knots are not used P c Cannot push the cord into the equipment to cause P a HAZARD lt 11402142 253 gt 24 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict d No failure of cord insulation in anchorage with P metal parts e Not to be loosened without a tool f Cord replacement does not cause a HAZARD and method of strain relief is clear Push pull and or torque test see Form A 15 6 10 3 Plugs and connectors Approved power cord is used MAINS supply plugs connectors etc conform with P relevant specifications If equipment supplied at voltages below 6 3 2 a or from a sole source Plugs of supply cords do not fit MAINS sockets above P rated SUPPLY voltage MAINS type plugs used only for
41. in the manual P f instructions for protective earthing EN 61010 2 P 101 g the sound data required by 12 5 1 EN 61010 2 N A 101 h instructions relating to the handling containment P and exhaust of hazardous substances including any requirements for preventing back syphonage EN 61010 2 101 i any drainage systems required where a HAZARD No drainage required N A could occur from the discharge of biological and chemical substances and hot fluids EN 61010 2 101 j details of protective measures relating to hazardous No radiation hazards N A radiation see clause 12 EN 61010 2 101 k connections to the supply EN 61010 2 101 P for PERMANENTLY CONNECTED EQUIPMENT Not a permanently N A only EN 61010 2 101 connected equipment 1 MAINS supply requirements and details of N A connections including the RATED temperature of the cable required at maximum RATED ambient temperature EN 61010 2 101 2 requirements for any external switch or circuit N A breaker see 6 11 2 1 and external overcurrent protection devices see 9 5 1 and a recommendation that the switch or circuit breaker be near the equipment if this is necessary for safety EN 61010 2 101 m requirements for special services for example air N A cooling liquid including pressure limits EN 61010 2 101 lt 11402142 253 gt 10 of 69 EN 61010 1 EN 61010 2 101 O Clause Requirement Test Result Remark
42. intended purpose of the device where appropriate the results of biophysical or modelling research whose validity has been demonstrated beforehand The devices must be designed manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport storage and use of the devices and to the patients taking account of the intended purpose of the product Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure 18 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 62304 2006 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 62304 2006 T ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 _Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 _Product Master file No MF07 Product user Manual XacPro S ver 201411 Description The devices must be designed and manufactured in such a way that they can be used safely with the materials substances and gases with which they enter into contact during their normal use or during routine procedures if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing these products and that
43. intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer Any undesirable side effect must constitute an acceptable risk when weighed against the performances intended Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 The device never directly touches patients in any material or energy pathway which can be imagined ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 System Cert No TW14 10079 _Risk Management Report No RM07 02 Description Appli ca Standard Sub clause s ble or not Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X Requirements regarding design and construction Chemical physical and biological properties YES The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the General requirements Particular attention must be paid to the choice of materials used particularly as regards toxicity and where appropriate flammability the compatibility between the materials used and biological tissues cells and body fluids taking account of the
44. of 45 PMG B BE EAS SE PRR RB TEL 886 4 2359 9009 M Precision Machinery Research amp Dev sma Center FAX 886 42352884 www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan EMS LOG SHEET OF EFT TEST Performance Criteria Test Result w w Paw fe fe ow e Pee fs Note N R means no requirement B means monitor flash N3E11 103R0454 018 Page 32 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA co M RI v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center YA No 27 37th Road Taichung Industrial Park Taichung Taiwan 7 6 Photo during the test N3E11 103R0454 018 Page 33 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 8 Immunity Test of Conducted Disturbances Induced by Radio Frequency Fields 8 1 Test specification and performance criteria AC input and AC output power ports Phenomena Test Performance Specification Standard Criteria MHz Radio Frequency V rms Common Mode Unmodulated rms EN 61000 4 6 Amplitude AM 1kHz Modulated Source Impedance 8 2 Test setup Power Meter Power Signal 6 dB Amplifier Generator Attenuator AC Main Power G
45. requirements of Annex H 6 7 2 2 Solid insulation P lt 11402142 253 gt 20 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict 6 7 2 2 1 Withstands electrical and mechanical stresses in P normal use and all RATED environmental conditions of 1 4 Equipment passed voltage tests of 6 8 3 with values of see Form A 14 P Table 5 Complies as applicable a ENCLOSURE or PROTECTIVE BARRIER Clause 8 b moulded and potted parts requirements of 6 7 2 2 2 No potted part c inner layers of printed wiring boards requirements N A of 6 7 2 2 3 d thin film insulation requirements of 6 7 2 2 4 P 6 7 2 2 2 Moulded and potted parts N A Conductors between same two layers are separated by N A at least 0 4 mm after moulding is completed 6 7 2 2 3 Inner insulation layers of printed wiring boards N A Separated by at least 0 4 mm between same two layers N A REINFORCED INSULATION have adequate electric N A strength one of following methods used a thickness at least 0 4 mm N A b insulation is assembled of minimum two separate N A layers each RATED for test voltage of Table 5 for BASIC INSULATION c insulation is assembled of minimum two separate N A layers where the combination is rated for test voltage of Table 5 for REINFORCED INSULATION 6 7 2 2 4 Thin film insulation No such parts N A Conductors between same
46. to be re sterilized and any restriction on the number of reuses Where devices are supplied with the intention that they be sterilized before use the instructions for cleaning and sterilization must be such that if correctly followed the device will still comply with the requirements in Section I If the device bears an indication that the device is for single use information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re used If in accordance with Section 13 1 no instructions for use are needed the information must be made available to the user upon request i details of any further treatment or handling needed before the device can be used for example sterilization final assembly etc j in the case of devices emitting radiation for medical purposes 37 Report Document Comments Clause Description Appli ca Standard Sub clause s Report Document Comments details of the nature type intensity and distribution of this radiation The instructions for use must also include details allowing the medical staff to brief the patient on any contra indications and any precautions to be taken These details should cover in particular k precautions to be taken in the event of changes in the performance of the device 1 precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic field
47. 0 51254 PITE PIX ve o ZVS H uebsny ol OWA d x NSZ d waji evasive v nra WF1944B WAVE FACTORY lt 71402142 253 gt 69 of 69 O REMARKS 1 The CE marking may only be used if all relevant and effective CE procedures are complied with 2 This report is submitted for the exclusive use of the client to whom it is addressed Its significance is subject to the adequacy and representative character of the sample s and to the comprehensiveness of the tests examinations or surveys made 3 This report justified only the submitted samples exclusively and not necessarily implies that all other samples are also to be found in same result 4 The instruction specified by the standard has to be in official language of each country however only English is checked for this report It is the applicant s responsibility to provide instruction in official language of the national Appendix C Verification of EMC Lr IS tS IVON t 2 2C lt AMO Precision Machinery Research amp Development Center Verification of Certificate Issued to MagQu Co Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan In respect of machinery manufactured by e MagQu Co Ltd Product Name Magnetic Immunoassay Analyzer Main Model XacPro S Serial No 001 140401 MO IDU The ve
48. 010 Third Eaifion ana 254 Cetpass April 8 2014 EN 61010 2 101 2002 The referred test report s show that the product fulfills the essential requirements in the Low Voltage Directive for CE marking On this basis together with the manufacturer s own documented production control the manufacturer or his European authorized representative can in his EC Declaration of Conformity verify compliance with the Low Voltage Directive Vincent Tan Engineering Department 57 lt 71402142 253 gt Page 1 of 69 TEST REPORT EN 61010 1 amp EN 61010 2 101 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements Part 2 101 Particular requirements for in vitro diagnostic IVD medical equipment Report reference No T1402142 253 Tested by printed name and signature Marty Chen Approved by printed name and signature Jasson Shiu Date of issue April 8 2014 CERPASS TECHNOLOGY CORP 9f No 200 Gangcian Rd Neihu District Taipei City 114 Taiwan as above MagQu Co Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Test specification 1 EN 61010 1 2010 and EN 61010 2 101 2002 Test procedure IVD LVD Verification Report Procedure deviation
49. 1 EN Mains switch ON un NOTE A 10 s test is specified in 6 1 2 a b A5 s test is specified in 6 10 3 The capacitance level versus voltage below the limits given from figure 3 of IEC 61010 1 Supplementary information 47 69 lt 1402142 253 gt 61010 1 61010 2 101 Result Remark Verdict Requirement Test 6 3 2 TABLE Values in SINGLE FAULT CONDITION Subclause Voltage Transient Current Capacitance and see NOTE see fault No V V V Test mA mA uF Comments r m s peak d c V circuit r m s peak d c see NOTE A1 A2 A3 Form A 6 see Form A 2 1 102 lt 2 lt 2 lt 0 1 E EN 2 0 1 2 1to2 lt 2 NOTE Transient voltages must be below the limits given from Figure 2 and the capacitance below the limits from figure 3 of IEC 61010 1 Supplementary information lt 71402142 253 gt Page 48 of 69 O EN 61010 1 EN 61010 2 101 Result Remark Verdict Clause Requirement Test 6 5 2 2 TABLE Cross sectional area of bonding conductors Form A 9 CONDUCTOR LOCATION CROSS SECTIONAL AREA VERDICT mm GND pin of inlet to enclosure 0 8mm P TABLE Bonding impedance of plug connected equipment Form A 10 P Test Voltage attained Calculated resistance Verdict ACCESSIBLE part under test current after 1 min Maximum 0 1 or 0 2 O A V NOTE 2 Q NOTE 1 NOTE 1
50. 1 103R0454 018 Page 16 of 45 dk cnt gt TEL 886 4 2359 9009 P4 M b RH B BRAT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center YA No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC LOG SHEET OF RE TEST IN FRONT OF EUT HOR 3m Trace 10 0 00 1 1 1 1 1 1 1 1 1 1 300 1000 200 0 300 0 400 0 500 0 600 0 700 0 800 0 900 0 1000 0 frequency N Freq Reading Corr Result Limit Margin ia MHz dBuV dB dBuV m dBuV m dB 1 34 850 23 059 16 429 39 487 50 000 10 513 2 54 250 31 307 7 564 38 870 50 000 11 130 3 129 425 24 011 12 430 36 441 50 000 13 559 4 143 975 32 187 11 795 43 981 50 000 6 019 5 153 137 20 108 11 254 31 362 50 000 18 638 6 214 300 25 870 9 755 35 625 50 000 14 375 7 262 800 21 828 14 332 36 160 57 000 20 840 N3E11 103R0454 018 Page 17 of 45 dk cnt gt TEL 886 4 2359 9009 P4 M b RH B BRAT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Www pmc oreiw No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC LOG SHEET OF RE TEST IN FRONT OF EUT VER 3m Trace QPLMT LA QP 300 1000 2000 3000 4000 5000 6000 7000 9000 10000 frequency No Freq Reading Corr Result Limit Margin MHz dBuV dB dBuV m dBuV m dB 1 35 575 23 910 16 027 39 9
51. 12 EN 15223 1 2012 EN 61010 1 2010 EN 61010 2 101 2002 Report Document Comments Product Master file No MF07 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 f g h i j and m are excluded Product Master file No MF07 Product user Manual Clause Description Appli ca Standard Sub clause s ble or not manufacturer does not have a registered place of business in the Community b the details strictly necessary for the user to identify the device and the contents of the packaging c where appropriate the word STERILE d where appropriate the batch code preceded by the work LOT or the serial number e where appropriate an indication of the date by which the device should be used in safety expressed as the year and the month f where appropriate an indication that the device is for single use A manufacturer s indication of single use must be consistent across the Community if the device is custom made the words custom made device if the device is intended for clinical investigations the words exclusively for clinical investigations any special storage and or handling conditions j any special operating instructions any warnings and or precautions to take 1 year of manufacture for active
52. 150 N Temporary force below 250 N for an area at least of 3 N A cm for a maximum duration of 0 75 s 7 3 5 Gap limitations between moving parts see Form A 16 N A 7 3 5 1 Access normally allowed Moving part are enclosed N A If levels of 7 3 4 exceeded and body part may be N A inserted minimum gap as specified in Table 13 assured in NORMAL and in SINGLE FAULT CONDITION 7 3 5 2 Access normally prevented Maximum gap as specified in Table 14 assured in Gap is less than 4mm NORMAL and in SINGLE FAULT CONDITION 7 4 Stability Equipment not secured to building structure is physical Equipment and assemblies stable of equipment is physically stable in normal use Stability maintained after opening of drawers etc by No drawer or the likes N A lt 11402142 253 gt 27 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict warning marking requires the application of means No means provided for N A ensuring of the stability Compliance checked by following tests as applicable a 10 tilt test for other than handheld equipment b multi directional force test for equipment exceeds height of 1 m and mass of 25 kg c downward force test for floor standing equipment P d overload test with 4 times maximum load for castor No the specified equipment N A or support that supports greatest load e
53. 2 6 2 Applied Standards for Electromagnetic Compatibility Directive EN 61326 1 2013 EN 55011 2009 A1 2010 6 3 Applied Standards for Software Life Cycle Processes EN 62304 2006 6 4 Applied Standards for Risk Management ISO 13485 2012 ISO 14971 2007 ISO 9001 2008 49 7 Product Validation amp Verification 7 1 Compliance with Standards 7 1 1 Issued Standards The XacPro S is issued for Low Voltage Directive 2006 95 EC and In Vitro Diagnosis IVD Directive 98 79 EC and Electromagnetic Compatibility Directive 2004 108 EC by Cerpass with standards EN 61010 1 2010 Third Edition and EN 61010 2 101 2002 on April 8 2014 and EMC by PMC with standards EN 61326 1 2013 and EN 55011 2009 A1 2010 on March 14 2014 The Magnetic Immunoassay Analyzer on MagQu is also assessed and certified the meeting the requirements of ISO 13485 2012 and ISO 9001 2008 by SGS 7 1 2 References Please see Appendix B G for further information 7 2 Performance Evaluation Clinical Data 7 2 1 Subjects In total we recruited 109 control subjects age 15 81 years old 62 women 47 men 24 subjects with mild cognition impairment MCI due to Alzheimer s disease AD age 55 95 years old 12 women 12 men and 62 subjects with AD age 53 89 years old 28 women 34 men In AD group 32 subjects are with early stage AD and 30 subjects are with mild severe AD Subjects are grouped into control MCI due to AD early stage AD and mild severe AD
54. 2 C C Yang S Y Yang H H Chen W L Weng H E Horng J J Chieh C Y Hong and H C Yang Effect of molecule particle binding on the reduction in the mixed frequency ac magnetic susceptibility of magnetic bio reagents J Appl Phys 112 24704 2012 S Y Yang J J Chieh K W Huang C C Yang T C Chen C S Ho S F Chang H H Chen H E Horng C Y Hong and H C Yang Molecule assisted nanoparticle clustering effect in immunomagnetic reduction assay J Appl Phys 113 144903 2013 J J Cheih S Y Yang H E Horng C Y Yu C L Lee H L Wu C Y Hong and H C Yang Immunomagnetic reduction assay using high T superconducting quantum interference device based magnetosusceptometry J Appl Phys 107 074903 1 074903 5 2010 M J Chiu H E Horng J J Chieh S H Liao C H Chen B Y Shih C C Yang C L Lee T F Chen S Y Yang C Y Hong and H C Yang Multi channel SQUID based ultra high sensitivity in vitro detections for bio markers of Alzheimer s disease via Immunomagnetic Reduction IEEE Trans Appl Supercond 21 477 2011 3 Production 3 1 Bill OF Material No Project Quantity 1 Coil 1 2 SQUID System 1 3 Electronics 1 4 Shielding and shell 1 3 2 Specification of Materials Used Test Name Standard Method Project No collision damage distortion or other Exterior f Visual adverse circumstances Excitation coil 1
55. 2002 EN 15223 1 2012 Directive 98 79 EC ISO 13485 2012 ISO 14971 2012 Directive 98 79 EC ISO 13485 2012 EN 61010 1 2010 EN 61010 2 101 2002 EN 15223 1 2012 EN 62304 2006 Report Document ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 _ Product Master file No MF07 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Product user Manual XacPro S ver 201411 Comments i k l m n o p and q are excluded Clause Description Appli ca Standard Sub clause s nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times e where appropriate information to avoid certain risks in connection with implantation of the device f information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment g the necessary instructions in the event of damage to the sterile packaging and where appropriate details of appropriate methods of re sterilization h if the device is reusable information on the appropriate processes to allow reuse including cleaning disinfection packaging and where appropriate the method of sterilization of the device
56. 3 gt 38 of 69 EN 61010 1 EN 61010 2 101 O Clause Requirement Test Result Remark Verdict Data shows conformity with V 1 of IEC 60695 11 10 Printed circuit boards of P or better or material with a flammability classification of FV 0 min of IEC60707 or UL94 Test shows conformity with V 1 of IEC 60695 11 10 or see Form A 18 N A better Not applicable for printed wiring boards with limited N A energy circuits 9 4 14 8 Circuits or components used as transient overvoltage No such parts N A limiting devices Test conducted between each pair of MAINS SUPPLY see Form A 30 N A TERMINALS No HAZARD resulting from rupture or overheating of the N A component no bridging of safety relevant insulation N A no heat to other parts above the self ignition points N A 15 PROTECTION BY INTERLOCKS N A 15 1 Interlocks are designed to remove a HAZARD No interlock N A before OPERATOR exposed 15 2 Prevention of reactivation N A 15 3 Reliability N A Single fault unlikely to occur or N A Cannot cause a HAZARD N A 16 HAZARDS RESULTING FROM APPLICATION 16 1 REASONABLY FORESEEABLE MISUSE No HAZARDS arising from settings not intended and not described in the instructions Other cases of REASONABLY FORESEEABLE MISUSE P addressed by RISK assessment 16 2 Ergonomic aspects P Factors giving rise to a HAZARD the RISK assessment is P refl
57. 31 C decreasing to 50 RH at 40 C Transient overvoltage at mains supply 2500V Pollution degree 2 Disposal of product discarded Please refer to following instructions when recycling any instrument or component Equipment recycling nature resources of the equipment need to be recycled and reused In the event that the equipment is not disposed correctly during discard it may produce substances hazardous to the environment or human health In order to avoid emission of such substances in the environment and reduce use of natural resources recycling the product with a proper system is recommended for the purpose of ensuring most materials can be recycled and reused appropriately 2 5 Duet Labeling Mag u Magnetic Immunoassay Analyzer Model NO XacPro S Serial NO XacPro S 201403001 MQ Rating 110 230VAC 50 60Hz 500W M D 03 2014 MagQu Co Ltd http www magqu com GmbH Made in Taiwan Borkstratte 10 48163 M nster Germany Reference 2 1 C Y Hong C C Wu Y C Chiu S Y Yang H E Horng and H C Yang 2 2 2 3 2 4 2 5 2 6 Magnetic Susceptibility Reduction Method for Magnetically Labeled Immunoassay Appl Phys Lett 88 212512 2006 C C Yang S Y Yang J J Chieh H E Horng C Y Hong and H C Yang Universal behavior of bio molecule concentration dependent reduction in ac magnetic susceptibility of bio reagents IEEE Magn Lett 3 1500104 201
58. 37 50 000 10 063 2 44 550 34 714 11 108 45 822 50 000 4 178 3 66 375 29 655 6 461 36 116 50 000 13 884 4 117 300 26 899 12 066 38 965 50 000 11 035 5 173 075 28 323 9 987 38 309 50 000 11 691 6 253 100 22 796 13 680 36 475 57 000 20 525 7 350 100 27 766 15 066 42 832 57 000 14 168 8 398 600 30 237 16 724 46 961 57 000 10 039 N3E11 103R0454 018 Page 18 of 45 DNG R1 BLAUE SER R F SERE RP S Precision Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan TEL 886 4 2359 9009 FAX 886 4 2359 8847 WWW pmc org tw EMC LOG SHEET OF RE TEST IN RIGHT FRONT OF EUT HOR 3n 1000 2000 3000 4000 5000 6000 frequency 700 0 900 10000 Trace QPLMT LA QP No Freq Reading Corr Result Limit Margin MHz dBuV dB dBuV m dBuV m dB 1 32 425 17 923 17 536 35 459 50 000 14 541 2 59 100 28 914 6 519 35 433 50 000 14 567 3 124 575 26 918 12 330 39 247 50 000 10 753 4 141 550 30 725 11 963 42 687 50 000 7 313 5 149 187 19 641 11 433 31 074 50 000 18 926 6 168 225 25 431 10 348 35 778 50 000 14 222 7 209 450 26 885 9 646 36 531 50 000 13 469 N3E11 103R0454 018 Page 19 of 45 dk cnt gt TEL 886 4 2359 9009 P4 M b RH B BRAT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichu
59. 4 Not protect by impedance N A 6 4 2 ENCLOSURES or PROTECTIVE BARRIERS see Form 13 meet rigidity requirements of 8 1 meet requirements for BASIC INSULATION if protection is provided by insulation meet requirements of 6 7 for CREEPAGE and P CLEARANCES between ACCESSIBLE parts and HAZARDOUS live parts if protection is provided by limited access 6 4 3 BASIC INSULATION see Form A 13 meet CLEARANCE CREEPAGE DISTANCE and solid insulation requirements of 6 7 6 4 4 Impedance see Form A 12 N A Impedance used as primary means of protection meets Not protect by impedance all of following requirements a limits current or voltage to level of 6 3 2 see Form A 7 N A b RATED for maximum WORKING VOLTAGE and the N A amount of power it will dissipate C CLEARANCE CREEPAGE DISTANCE between see Form A 13 N A terminations of the impedance meet requirements Of BASIC INSULATION of 6 7 6 5 Additional means of protection in case of SINGLE FAULT CONDITION 6 5 1 ACCESSIBLE parts are prevented from becoming HAZARDOUS live by the primary means of protection and supplemented by one of 8 PROTECTIVE BONDING see 6 5 2 Class I P b SUPPLEMENTARY INSULATION see 6 5 3 P C automatic disconnection of the supply see 6 5 5 N A d current or voltage limiting device see 6 5 6 P Alternatively one of the single means of protection is P used e REINFORCED INSULATION see 6 5 3 For the insulating parts P f PROTECTIVE IMPEDANCE see 6 5 4 N A
60. 5 kV N A peak or d c 6 3 2 Levels in SINGLE FAULT CONDITION see Form A 7 a Voltage limits less than 33 V r m s and 46 7 V The accessible voltage peak or 70 V d c levels not exceed 55V r m s and 78V peak or 140V d c for wet locations voltage limits less than 16 V r m s Dry location only N A and 22 6 V peak or 35 V d c Voltages are not HAZARDOUS LIVE the levels of b Current less than 0 5 r m s for sinusoidal 0 7 The accessible voltage N A mA peak non sinusoidal or mixed frequencies or2 levels not exceed 55V mA d c when measured with measuring circuit r m s and 78V peak or or A 2 if less than 100 Hz 140V d c for wet locations measuring circuit A 4 used or N A C Levels of capacitive charge or energy less N A 1 45 uC for voltages up to 15 kV peak or d c or N A line A of Figure 3 2 350 mJ stored energy for voltages above 15 kV N A peak or d c 6 4 Primary means of protection 6 4 1 ACCESSIBLE parts prevented from being HAZARDOUS Enclosures and barriers LIVE by one or more of following means surrounding the hazardous live meet the rigidity requirements 8 ENCLOSURES or PROTECTIVE BARRIERS see 6 4 2 b BASIC INSULATION see 6 4 3 lt 11402142 253 gt 14 of 69 61010 1 61010 2 101 O Clause Requirement Test Result Remark Verdict c Impedance see 6 4
61. AL and SINGLE FAULT There is no spread of fire CONDITION outside the equipment in normal or single fault condition MAINS supplied equipment meets requirements of 9 6 OCP is provided in the P additionally adapter Conformity is checked by minimum one or a P combination of the following see Figure 11 a Faulttest of 4 4 or see Form A 1 and Form P A 2 b Application of 9 2 eliminating or reducing the P sources of ignition or c Application of 9 2 containment of fire within the P equipment 9 2 Eliminating or reducing the sources of ignition within the Considered to be reduced P equipment to a tolerable level a 1 Limited energy circuit see 9 4 or Not determine to Limited N A energy circuit 2 BASIC INSULATION provided for parts of see Form A 5 and A 14 P different potential or Insulation between parts at different potentials meets the requirements for basic insulation lt 11402142 253 gt 30 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict Bridging the insulation does not cause ignition see Form A 2 P It can be demonstrated that bridging the insulation will not cause ignition b Surface temperature of liquids and parts see 9 5 No flammable liquid or parts N A c No ignition in circuits designed to produce heat see Form A 2 N A No circuit designed to produce heat
62. ATION AND PERFORMANCE CRITERIA 8 27 51 SETUP RU TERRAS O4 8 3 ENVIRONMENTAL CONDITIONS eese ee eoo to sone tosta suasono oo asnosi osode ssoi pes saisi pasaspa staps sees ense ee enseses OO 8 4 DESCRIPTION OF THE TEST UR siase ssiase M 25 35 8 5 TEST RESULI MH 35 8 6 PHOTO DURING THE TEST 37 9 SURGE IMMUNITY TEST 9 1 TEST SPECIFICATION AND PERFORMANCE CRITERIA 6628 0 9 3 ENVIRONMENTAL CONDITIONS sese 39 9 4 DESCRIPTION OF THE TEST 39 9 5 TEST RESULT MEE UO T 39 N3E11 103R0454 018 Page 3 of 45 D Ye cz Lk ge zs is TEL 886 4 2359 9009 INA ib RH B AH 3 BRAT Zb ya he FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 10 IMMUNITY TEST OF RADIATED RADIO FREQUENCY ELECTROMAGNETIC
63. E 3342490003 YA 12345678 910 Stand MUSA gt N3E11 103R0454 018 Page 5 of 10 IM CP HJ KAA BARR RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 11 Inside of EUT 1 6 12 Inside of EUT 2 1 N3E11 103R0454 018 Page 6 of 10 IM CP HJ KAA BART RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center PAX 886 4 2359 8847 WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 13 Inside of EUT 2 2 J La ssh 14 Inside of EUT 2 3 N3E11 103R0454 018 Page 7 of 10 IM CP HJ KAA BARR RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 15 Inside of EUT 2 4 N3E11 103R0454 018 Page 8 of 10 IM CP HJ KAA BART RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 17 Inside of EUT 3 1 N3E11 103R0454 018 Page 9 of 10 IM CP HJ KAA BART RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 19 Inside of
64. FILED PULSE MODULATED vacecsossececuectetbassecedtsscsvdcbevetsodsscbebes 42 10 1 TEST SPECIFICATION AND PERFORMANCE CRITERIA 42 10 2 ka SASA WASI wa ka KA D aa 42 10 3 ENVIRONMENTAL CONDITIONS 43 10 4 DESCRIPTION OF THE TEST ivsscieccicvccssscesscsectecesescscsecdessesievecessdesessotstssteesosuestedstsecssdosgectassedetsedesdestosecscsvstescestese 43 10 5 TEST OUI EIC 43 10 6 PHOTOS DURING THE TES Tesiisccssictssteccicccesssctdacesses cutascevascanssnseeacccucesscsansndsesstasescasescovss secesscoaescevadedcscsssasaceensensce 45 Attachment Photograph of EUT Attachment Parts List N3E11 103R0454 018 Page 4 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA M RI v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan Laboratory Information Precision Machinery Research amp Development Center PMC was founded by government and Taiwan Association of Machinery Industry established on June 1 1993 We are a non profit organization to help manufacturers to value up the products and comply with the EMC and Safety requirement And our facilities and ability of measurement are approved by the f
65. General Where necessary for safety indication of purpose of Purpose is marked TERMINALS connectors controls and indicators marked N Adequately marked P If insufficient space symbol 14 used Push buttons and actuators of emergency stop devices No emergency stop and indicators used only to indicate a warning of danger or N A the need for urgent action N A coloured red N A coded as specified in IEC 60073 N A Supplementary means of coding provided if meaning N A of colour relates see IEC 60073 to safety of persons or N A lt 11402142 253 gt Page 6 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict safety of the environment N A 5 1 5 2 TERMINALS MAINS supply TERMINAL identified Other TERMINAL marking a FUNCTIONAL EARTH TERMINALS symbol 5 used ik ede i b PROTECTIVE CONDUCTOR TERMINALS Power cord is used Symbol 6 Dis placed close to or on the TERMINAL Or Part of appliance inlet N A TERMINALS of control circuits symbol 7 used a Ae i WA d HAZARDOUS LIVE TERMINALS supplied from the No live terminal supplied N A interior from interior Standard MAINS socket outlet or N A RATINGS marked or N A Symbol 14 used N A 5 1 6 Switches and circuit breakers Breaker is used P If disconnecting device off position clearly marked P If push button used as power supply switch N
66. Is the medical device supplied sterile or intended to be sterilized by the user or are other microbiological controls applicable Ans No C 2 9 Is the medical device intended to be routinely cleaned and disinfected by the user Ans No C 2 10 Is the medical device intended to modify the patient environment Ans No C 2 11 Are measurements taken Ans Yes to measure the IMR signal form reagents C2 12 Is the medical device interpretative Ans Yes C 2 13 Is the medical device intended for use in conjunction with other medical device medicines or other medical technologies Ans Yes the samples should be measured with reagents C 2 14 Are the unwanted outputs of energy or substances Ans No C2 15 Is the medical device susceptible to environmental influences Ans Yes the performance of the reagent would be affected by unstable temperatures and strong magnetic environment C 2 16 Does the medical device influence the environment 40 Ans Yes it provides magnetic field and heat C 2 17 Are there essential consumables or accessories associated with the medical device Ans No C 2 18 Is the maintenance and or calibration necessary Ans Yes the maintaining methods should be describing in operation manual C 2 19 Does the medical device contain software Ans Yes the software is a part of the XacPro S C2 20 Does the medical device have a restricted shelf life Ans Yes C 2 21 Are there
67. LATION 2 if operating altitude is greater than 2000 m values Not over 2000 m N A of CLEARANCES multiplied with factor of Table 3 3 minimum CLEARANCE is 0 2 mm for POLLUTION N A DEGREE 2 and 0 8 mm for POLLUTION DEGREE 3 6 7 3 3 CREEPAGE DISTANCES Based on WORKING VOLTAGE meets the values of Table 7 for BASIC and SUPPLEMENTARY INSULATION Values for REINFORCED INSULATION are twice the values P of BASIC INSULATION Coatings to achieve reduction to POLLUTION DEGREE No coating N A comply with requirements of Annex H 6 7 3 4 Solid insulation N A 6 7 3 4 1 Withstands electrical and mechanical stresses in N A normal use and all RATED environmental conditions of 1 4 a Equipment passed voltage test of 6 8 3 1 for 5 s see Form A 14 N A with VALUES of Table 6 for BASIC and SUPPLEMENTARY INSULATION values for REINFORCED INSULATION are 1 6 times the Complied with P I test P values of BASIC INSULATION b if WORKING VOLTAGE exceeds 300 V equipment see Form A 14 N A passed voltage test of 6 8 3 1 for 1 min with a test Not 300V voltage of 1 5 times working voltage for BASIC or ecd SUPPLEMENTARY INSULATION value for REINFORCED INSULATION are twice the Same as above N A WORKING VOLTAGE Complies as applicable N A 1 ENCLOSURE or protective barrier Clause 8 N A lt 11402142 253 gt 22 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result
68. Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan 3 Conducted Emission Test 3 1 Limits of terminal disturbance voltage TEL 886 4 2359 9009 FAX 886 4 2359 8847 www pmc org tw Port Frequency Range ens quency Rang 16 A Per Phase Standard 79 dB uV quasi peak 0 15 MHz 0 50 MHz 66 dB uV average AC Mains 73 dB pV quasi peak EN 55011 0 50 MHz 5 MHz 60 dB uV average 73 dB pV quasi peak 5 MHz 30 MHz 60 dB uV average 3 2 Test setup EUT EMI Receiver AC Mains Power Filter N3E11 103R0454 018 Page 10 of 45 PMG B BE EAS SE PRR RB TEL 886 4 2359 9009 886 4 2359 M Precision Machinery Research amp Center 8847 No 27 37th Road Taichung Industrial Park Taichung Taiwan 3 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Pressure Mar 11 Mar 11 2014 24 8 55 5 1018 mbar mbar 3 4 Description of the test 1 Positive peak was done first to find the frequency ranges required then to do the quasi peak value and average value measurement Each phase of power lines was to be tested 2 The power cores should be equipped with main breaker Each of phases has tested as the following pages 3 5 Test result The following pages show the results of conducted emission test Judging from these data it is reasonable to assume
69. NG THE TEST ES RI RATES ET NIU 21 5 ELECTROSTATIC DISCHARGE IMMUNITY TEST 22 5 1 TEST SPECIFICATION AND PERFORMANCE CRITERIA 5 2 TEST u u MEME E 22 22 5 3 ENVIRONMENTAL CONDITIONS 23 5 4 DESCRIPTION OF THE TEST 23 5 5 TEST RESULI se UE KANISA 23 5 6 PHOTOS DURING THE TEST N3E11 103R0454 018 Page 2 of 45 25 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 6 IMMUNITY TEST OF RADIATED RADIO FREQUENCY ELECTROMAGNETIC FIELD AMPLITUDE MODULATELD AE
70. O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 11 7 2 TABLE Leakage and rupture at high pressure Form A 25 N A Maximum Part permissible Test Leakage Deformation Burst Comments working pressure pressure Mpa MPa Yes No Yes No Yes No NOTE see also Annex G with requirements for USA and Canada Supplementary information 11 7 3 Leakage from low pressure parts N A Test Leakage Part pressure Comments Mpa Yes No Supplementary information TABLE lonizing radiation N A 12 2 1 2 Equipment intended to emit radiation Measured values Verdict Locations tested uSv h Comments Supplementary information Equipment not intended to emit radiation N A Max allowed effective dose rate at 100 mm 1 uSv h Measured values Verdict Locations tested uSv h Comments Supplementary information lt 71402142 253 gt Page 59 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 12 5 1 TABLE Sound level Form 27 NA Locations tested Measured values Calculated maximum sound dBA pressure level At operator s normal position and at bystanders positions 2 e f Supplementary information 12 5 2 Ultrasonic pressure N A Locations tested Measured values Comments dB kHz At operator s normal position At 1 m from the ENCLOSURE
71. ROTECTIVE CONDUCTOR of measuring circuit N A 1 Current RATING equivalent to measuring circuit N A TERMINAL 2 PROTECTIVE BONDING shall not be interrupted N A Devices used for indirect bonding in test and measurement circuits are permitted to be part of the PROTECTIVE BONDING i FUNCTIONAL EARTH TERMINALS allow independent N A connection j If a binding screw used for PROTECTIVE N A CONDUCTOR TERMINAL Suitable size for bond wire N A Not smaller than M 4 No 6 N A At least 3 turns of screw engaged N A Passes tightening torque test N A k Contact pressure not capable being reduced by N A deformation of materials 6 5 2 4 Impedance of PROTECTIVE BONDING of plug connected 0 020hm measured passing P equipment 25Aac current from earthing terminal of inlet to inside metal part see Form A 10 Impedance between PROTECTIVE CONDUCTOR TERMINAL and each ACCESSIBLE part where PROTECTIVE BONDING is specified is less than 0 1 Ohm or N A less than 0 2 Ohm if equipment is provided with non 0 020hm P detachable cord 6 5 2 5 Bonding impedance of PERMANENTLY CONNECTED see Form A 10 N A EQUIPMENT Not permanently connected 6 5 2 6 Transformer PROTECTIVE BONDING screen see Form A 11 N A Transformer provided with screen for protective No such screen is used N A bonding lt 11402142 253 gt 17 of 69 EN 61010 1 EN 61010 2 101 Clause Re
72. RP 1mx1m N3E11 103R0454 018 Page 34 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 8 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 53 8 9 1012 mbar 8 4 Description of the test 1 During the test the frequency range was swept from 0 15 to 80 MHz incrementally with 1 step size of each frequency The test signal was 80 amplitude modulated with kHz sine wave 2 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 3 The test was repeated when the EUT was in idle standby state 8 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfully N3E11 103R0454 018 Page 35 of 45 E ik Ez gt TEL 886 4 2359 9009 P4 M b RH B BRIT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan RESULTS OF CS TEST _ Performance Description Requirement m Test Result Criteria AC Input Power C
73. Technical Documentation for IVD According to the Medical Devices Directive 98 79 EC Related to Magnetic Immunoassay Analyzer Products Device designation Catalogue number Magnetic Immunoassay Analyzer XacPro S Document number RDR 14 0004 Outline 1 Declaration of Conformity 2 Product Description 3 Production 4 Essential Requirement ER Assessment 5 Risk Management 6 Applicable Standards 7 Product Validation amp Verification Appendix 10 13 39 49 50 56 1 Declaration of Conformity 1 1 Declared Product Type of product Magnetic Immunoassay analyzer Type Designation XacPro S 1 2 Applied Standard EN 61010 1 2010 Third Edition EN 61010 2 101 2002 EN 61326 1 2013 EN 55011 2009 A1 2010 1 3 Declared Company Company Name MagQu Co Ltd Address 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan 14 Declaration Date and Place April 8 2014 Taiwan 1 5 Reference Further information is described in Appendix A to C 2 Product Description 2 1 Introduction The Magnetic Immunoassay Analyzer XacPro S designed by MagQu Co Ltd is used to measure the change in the ac magnetic susceptibility of a sample over time If the sample is a mixture of a magnetic reagent and an object to be detected XacPro S can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility which i
74. able L N Earth Port Note N R means no requirement N3E11 103R0454 018 Page 36 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 M b M RI v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan S 6 Photo during the test N3E11 103R0454 018 Page 37 of 45 dence Precision Machinery Research amp Development Center 7 www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 9 Surge Immunity Test 9 1 Test specification and performance criteria Test Port Test Basic Performance Specification Standard Criteria A C Power Port 1 2 50 8 20 Line to PE 2 EN 61000 4 5 tl Line to Line 9 2 Test setup Surge Generator AC Main Power GRP 1m x 1m N3E11 103R0454 018 Page 38 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 9 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 24 6 C 53 8 9 1012 mbar 9 4 Description of the test 1 Overview 5 negative and 5 positive Impulses and Source impedance generator line to line 2 line neutral to earthz12 Phase shifting in between 0
75. afety and health of users or where applicable other persons provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety This shall include reducing as far as possible the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used design for patient safety and consideration of the technical knowledge experience education and training and where applicable the medical and physical conditions of intended users design for lay professional disabled or other users The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles taking account of the generally acknowledged state of the art In selecting the most appropriate solutions the manufacturer must apply the following principles in the following order eliminate or reduce risks as far as possible inherently safe design and construction where appropriate take adequate protection measures including alarms if necessary in relation to risks that cannot be eliminated inform users of the residual risks due to any shortcomings of the protection measures adopted YES 16 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 EN 61326 1 2006
76. al to noise ratio gt 10 for the mixture of 80 0 3 emu g magnetic fluid and 40 PBS solution Signal stability CV lt 10 Amplitude of applied ac magnetic field lt 20 Gauss Input voltage 110 230 Vac 50 60 Hz 500 W Magnetic signal sensor HTS SQUID Magnetometer Operation temperature 25 2 C Operation humidity lt 50 Sample volume 120 ul XacPro S is capable of quantitatively detecting the ultra low concentration of bio targets with aids of reagents with adequate bio functionalized magnetic particles The low detection limits using XacPro S are listed for examples Bio target Reagent Low detection limit Amyloid 1 40 IMR reagent p amyloid 40 4 9 pg ml 0060 Amyloid 1 42 IMR reagent p amyloid 42 7 53 pg ml MF AB2 0060 Tau protein IMR reagent Tau protein 0 002 pg ml MF TAU 0060 2 4 Warning And Precautions l Prevent fire or personal injury Use proper power line Please use only the power line designated for the product and approved in the country where the product is used 10 11 12 13 14 15 Correct connection amp disconnection Before lunching computer please confirm whether the power is switching on Switch off the power after shutting down the computer Ground the product The product is grounded through a ground conductor of the power cord In order to avoid electric shock the grounding conductor must be connected to the ground Please co
77. and AC output power ports Phenomena Test Units Basic Performance Specification Standard Criteria kV Peak Fast Transients Tr Td ns EN 61000 4 4 See 7 2 Rep Frequency kHz 7 2 Test setup EFT Generator AC Main Power GRP Im x 1m N3E11 103R0454 018 Page 30 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 7 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 24 6 53 8 1012 mbar 7 4 Description of test 1 The test was setup by coupling decoupling network and a series of positive and negative polarity transients was direct injection on AC Input power cable or Amps of the main power of the EUT more than 32A use capacitive clamp to represent by coupling decoupling network 2 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 3 The test was repeated when the EUT was in idle standby state 7 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfully N3E11 103R0454 018 Page 31
78. and a force of 10N Same as above 6 2 3 Openings above parts that are HAZARDOUS LIVE No top openings N A test pin with length of 100 mm and 4 mm in diameter applied N A 6 2 4 Openings for pre set controls No pre set control opening N A test pin with length of 100 mm and 3 mm in diameter applied N A 6 3 Limit values for ACCESSIBLE parts 6 3 1 Levels in NORMAL CONDITION see Form A 7 lt 11402142 253 gt Page 13 of 69 EN 61010 1 EN 61010 2 101 O Clause Requirement Test Result Remark Verdict a Voltage limits less than 33 V r m s and 46 7 V The accessible voltage P peak or 70 V d c levels not exceed 33V r m s and 46 7V peak or 70V d c for wet locations voltage limits less than 16 V r m s Dry location only N A and 22 6 V peak or 35 V d c Voltages are not HAZARDOUS LIVE the levels of b Current less than 0 5 mA r m s for sinusoidal 0 7 The accessible voltage N A mA peak non sinusoidal or mixed frequencies 2 levels not exceed 33V r m s mA d c when measured with measuring circuit A 1 and 46 7V peak or 70V d c or A 2 if less than 100 Hz for wet locations measuring circuit A 4 used or N A C Levels of capacitive charge or energy less N A 1 45 uC for voltages up to 15 kV peak or d c or N A line A of Figure 3 2 350 mJ stored energy for voltages above 1
79. any biological pathway which can be imagined Clause Description Construction and environmental properties If the device is intended for use in combination with other devices or equipment the whole combination including the connection system must be safe and must not impair the specified performances of the devices Any restrictions on use must be indicated on the label or in the instructions for use Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible the risk of injury in connection with their physical features including the volume pressure ration dimensional and where appropriate ergonomic features risks connected with reasonably foreseeable environmental conditions such as magnetic fields external electrical influences electrostatic discharge pressure temperature or variations in pressure and acceleration the risks of reciprocal interference with other devices normally used in the investigations of for the treatment given risks arising when maintenance or calibration are not possible as with implants from ageing of materials used or loss of accuracy of any measuring or control mechanism Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 EN15223 1 2012 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 24 Report Documen
80. any delayed and or long term use effects Ans It may occur 2 22 what mechanical forces will the medical device be subjected Ans No the XacPro S is not working by mechanical force C 2 23 What determines the lifetime of the medical device Ans Using frequency C 2 24 Is the medical device intended for signal use Ans Yes C 2 25 Is safe decommissioning or disposal of the medical device necessary Ans Yes C 2 26 Does installation or use the medical devices require the special training or special skill Ans Yes C 2 27 How will information for safe use be provided Ans Presented in the manual or package insert C 2 28 Will new manufacturing processes need to be established or introduced Ans No C2 29 Is successful application of the medical device critically dependent on human factors such as the user interface Ans No C 2 29 Can you user interface design features contribute to use error Ans No C 2 29 2 Is the medical device used in an environment where distractions can cause use error Ans Yes C 2 29 3 Dose the medical device has connecting parts or accessories Ans No C 2 29 4 Dose the medical device have a control interface Ans Yes 41 C 2 29 5 Dose the medical device display information Ans Yes C 2 29 6 Is the medical device controlled by a menu Ans Yes C 2 29 7 Will the medical device be use by persons with special needs Ans Yes C 2 29 8 Can the user inte
81. bstances to or from the body or devices intended for transport and storage of such body fluids or substances contain phthalates which are classified as carcinogenic mutagenic or toxic to reproduction of category or 2 in accordance with Annex I to Directive 67 548 EEC these devices must be labelled on the device itself and or on the packaging for each unit or where appropriate on the sales packaging as a device containing phthalates If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements in particular of this paragraph within the technical documentation and within the instructions for use information on residual risks for these patient groups and if applicable on appropriate precautionary measures Devices must be designed and manufactured in such a way as to Directive 98 79 EC reduce as much as possible risks posed by the unintentional ingress ENISO13485 2012 of substances into the device taking into account the device and the ENISO14971 2012 nature of the environment in which it is intended to be used EN61010 1 2010 EN61010 2 101 2002 21 Report Document ISO 13485 Quality System Cert No TW14 10079 _ Product Master file No MF07 _Risk Management Report No RM07 02 Comments Clause Description Appli ca S
82. can be imagined The device is not intend to monitor patients Description Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment Protection against electrical risks Devices must be designed and manufactured in such a way as to avoid as far as possible the risk of accidental electric shocks during normal use and in single fault condition provided the devices are installed correctly Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN55011 2009 EN61326 1 2006 EN61010 1 2010 EN61010 2 101 2002 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 EN5011 2009 EN61326 1 2006 30 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 Product Master file No MF07 Risk Management Report No RM07 02 Product research files XacPro S ISO 13485 Quality System Cert No TW14 10079 _Risk Management Report No RM07 02 Product research files XacPro S Clause Description Protection against mechanical and thermal risks Devices must be designed and manufactured in such a way as to protect the patient and user against mechanical risk connected with for example resistance stability and
83. close to the SUPPLY 6 11 4 1 Switches and circuit breakers Breaker is used UU When used as disconnection device Meets IEC 60947 1 and IEC 60947 3 Marked to indicate function Not incorporated in MAINS cord Does not interrupt PROTECTIVE EARTH CONDUCTOR 6 11 4 2 Appliance couplers and plugs Where an appliance coupler or separable plug is used as the disconnecting device see 6 11 3 2 UU Readily identifiable and easily reached by the operator v Single phase portable equipment cord length not more than 3 m PROTECTIVE EARTH CONDUCTOR connected first and disconnected last PROTECTION AGAINST MECHANICAL HAZARDS Equipment does not cause a mechanical HAZARD in NORMAL nor in SINGLE FAULT CONDITION Operation not leads to a mechanical hazard in normal or single fault condition Conformity is checked by 7 2 to 7 7 7 2 Sharp edges No sharp edges Easily touched parts are smooth and rounded Do not cause injury during NORMAL USE and Do not cause injury during SINGLE FAULT CONDITION 7 3 Moving parts Moving part are enclosed 7 3 1 HAZARDS from moving parts limited to a tolerable level with the conditions specified in 7 3 2 and 7 3 5 U OU U U U RISK assessment in accordance with 7 3 3 carried out 7 3 2 Exceptions Moving pa
84. conductor N A Impedance meets 6 5 2 4 N A h Protective conductors bare or insulated Green Yellow wires are P if insulated green yellow used Exceptions N A 1 earthing braids N A 2 internal protective conductors etc N A Green yellow not used for other purposes P TERMINAL suitable for connection of a PROTECTIVE P CONDUCTOR and meets 6 5 2 3 6 5 2 3 PROTECTIVE CONDUCTOR TERMINAL Approved power cord is P used a Contact surfaces are metal Closed loop metal ring P terminal b Appliance inlet used F c For rewirable cords and PERMANENTLY CONNECTED Appliance inlet is used N A EQUIPMENT PROTECTIVE CONDUCTOR TERMINAL is Approved power cord is close to MAINS supply TERMINALS used d If no MAINS supply is required any PROTECTIVE Connected to mains supply N A CONDUCTOR TERMINAL Is near terminals of circuit for which protective N A earthing is necessary External if other terminals external N A lt 11402142 253 gt 16 of 69 EN 61010 1 EN 61010 2 101 O Clause Requirement Test Result Remark Verdict e Equivalent current carrying capacity to MAINS Approved power cord is P supply TERMINALS used f If plug in makes first and breaks last Not of plug in type N A g If also used for other bonding purposes protective N A conductor Applied first N A Secured independently N A Unlikely to be removed by servicing N A h P
85. d The device never directly touches patients or operators in any biological pathway which can be imagined The device never directly touches patients or operators in any biological pathway which can be imagined Clause Description Appli ca Standard Sub clause s ble or not Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate validated method Packaging systems for non sterile devices must keep the product without deterioration at the level of cleanliness stipulated and if the devices are to be sterilized prior to use minimize the risk of microbial contamination the packaging system must be suitable taking account of the method of sterilization indicated by the manufacturer Devices intended to be sterilized must be manufactured in appropriately controlled e g environmental conditions 8 4 8 5 ad 8 The packaging and or label of the device must distinguish between identical or similar products sold in both sterile and non sterile condition 23 Report Document Comments The device never directly touches patients or operators in any biological pathway which can be imagined The device never directly touches patients or operators in any biological pathway which can be imagined The device never directly touches patients or operators in any biological pathway which can be imagined The device never directly touches patients or operators in
86. d Control subjects had normal cognitive function confirmed by a battery of neuropsychological tests All subjects or their primary caregivers gave informed consent This study was approved by the ethics committee of the university hospital 7 2 2 Specimen Collection and Preparation Participants were asked to provide a 10 ml non fasting venous blood sample EDTA lavender top tube Each sample was assigned a registry number following the sampling sequence hence colleagues in the laboratory were blind to the clinical status and the demographic data of the subjects In consideration of the possible circadian changes and food effects on plasma all blood samples were collected between 10 AM and 2 PM and were postprandial The blood samples were centrifuged 2500 x g for 15 minutes within one hour of collection and plasma was aliquoted into cryotubes and stored at 80 C for less than three months until thawed for measurement 7 2 3 IMR Assays with Plasma 1 40 1 42 and Tau protein 7 2 3 1 Ratio of plasma 1 40 to AB 1 42 for the Risk Evalution of Patients Plasma samples of all subjects are used for 1 40 and 1 42 assays using 0060 and MF AB2 0060 respectively It was found that the concentration ratio of plasma 1 42 to Ap1 40 i e api 42 bapi 4o be a good diagnostic parameter for MCI AD The plasma api 47 0Ap1 40 distribution for normal controls MCI due to AD early stage AD and
87. d strength was 10 V M and kept this distance to the EUT during the test 2 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 3 The test was repeated when the EUT was in idle standby state 10 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfully N3E11 103R0454 018 Page 43 of 45 E ik Ez gt TEL 886 4 2359 9009 P4 M b RH B BRIT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC LOG SHEET OF RS TEST PULSE MODULATION Performance Description Requirement NM Test Result Criteria Control Panel Observation on EUT No unexpected movement was occurred N3E11 103R0454 018 Page 44 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA co M RI ik A EA T FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan 10 6 Photos during the test N3E11 103R0454 018 Page 45 of 45 ATTACHMENT Photograph of EUT IM CP HJ KAA BARR RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 www pmc o
88. dequate warnings SIRE Inadequate labeling Acceptable operation and maintain manual 5 2 Inadequate setting may 36 Setting devices by users 6 E n r device themselves is forbidd instructions ALARP emselves 15 forbidden Acceptable 5 7 Incorrect measurements Inadequate reagent may cause 4 The operators should be and other metrological incorrect measurement Acceptable well trained aspects 6 1 4 EM Inadequate reagent may cause The operators should be np Or Missing incorrect measurement ll trained instructions for use Acceptable we 6 6 The operators should be Inadequate reagent or ambiguous or unclear 4 well trained Also the measuring inadequate measuring steps presentation of settings steps should be clearly described may cause incorrect Acceptable measurements or other in the operation and maintaining measurement information manual 7 2 Lack of or inadequate specification for 4 The sales or agent should do The manual may lose some yari maintenance including SANI setting training to operators while situations which seldom occur Acceptable inadequate specification the device first setting of post maintenance functional checks The sales or agent should do 7 3 The manual may lose some 4 OS NEUESTE setting training to operators while Inadequate maintenance situations which seldom occur Acceptable the devic
89. diagnosis Design and Manufacture of Magnetic Immunoassay Analyzer Further clarifications regarding the scope of this certificate and the apolicability of 180 9001 2008 requirements may be obtained by consulting the organisation This certificate is valid from 27 January 2014 until 27 January 2017 and remains valid subject to satisfactory surveillance audits Re certification audit due before 21 October 2016 Issue 1 Certified since 27 January 2014 Authorised by SGS United Kingdom Ltd Systems amp Services Certification Rossmore Business Park Ellesmere Port Cheshire CH65 UK t 44 0 151 350 6866 1444 0 151 350 6600 www sgs com SGS 9001 8 01 0311 Page 1 of 1 This document is issued by the Company subject to ka General Conditions of Centfication Services at www sqa convierms_end_concitions him Atsan drawn D fiu of labi ty inceemifcation and juriatictonat Sues therein The authenticity of tis document may ba verified al htig eww sge comyen Our Diroctories aspx Any unawttoread alteration forgery or saficaton of the content cr eppearanca of tfe document s fui and may bo prosecuted to of th lw 60 sesic u 44 V UKAS MANAGEMENT SYSTEMS 005 Appendix F Certification of Good Manufacturing Practice GMP 1 ya v vj LI MINISTRY OF HEALTH AND WELFARE REPUBLIC OF CHINA TATWAN Issue Date
90. dication of particular training is required N A Specification of the need for personal protective N A equipment Conformity checked by evaluation of the RISK N A assessment documentation lt 11402142 253 gt 40 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict EN 61010 1 EN61010 2 101 Clause Subclause Title 4 4 2 1 SINGLE FAULT CONDITIONS not covered by 4 4 2 2 to 4 4 2 14 4 4 2 2 4 4 2 3 4 4 2 4 PROTECTIVE IMPEDANCE PROTECTIVE CONDUCTOR Equipment or parts for short term or intermittent operation 4 4 2 5 Motors stopped while fully energized prevented from starting one phase interrupted multi phase 4 4 2 6 4 4 2 7 Capacitors MAINS transformers Attach drawing of MAINS transformers showing all protective devices 4 4 2 8 4 4 2 9 4 4 2 10 Outputs Equipment for more than one supply Cooling air holes closed fans stopped coolant stopped loss of cooling liquid 4 4 2 11 Heating devices timer overridden temperature controller overridden 4 4 2 12 4 4 2 13 4 4 2 14 Insulation between circuits and parts Interlocks Voltage selectors List below all SINGLE FAULT CONDITIONS not covered by Supplementary information see Form A 2 for details of tests Requirement Test TABLE Summary of SINGLE FAULT CONDITIONS Result Remark Verdict Form 1
91. dle must be designed and constructed in such a way as to minimize all possible risks 12 7 5 Accessible parts of the devices excluding the parts or areas intended to supply heat or reach given temperatures and their surroundings must not attain potentially dangerous temperatures under normal use Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 32 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 _Risk Management Report No RM07 02 Product research files XacPro S ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 _Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 Clause 12 8 12 8 1 Description Appli ca Standard Sub clause s ble or not Protection against the risks posed to the patient by energy supplies or substances Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user Devices must be fitted with the means of preventing and or indicating any inadequacies in the flow rate which could po
92. e first setting Software or hardware may shut Every single part of product 78 down for some unknown 12 which transports power should be 4 mare reasons and it will cause accessed by safety guild to Functional Failure ALARP Acceptable incorrect measurement or give electrical shot to operators prevent any harm to operators while functional failure 47 4 6 Risk Benefit Comparison The risk management report demonstrated the benefit of XacPro S made by MagQu Co Ltd is better than risk to use it 4 7 Residual Risk Evaluation According to risk analysis process and management the residual risk is low and can be acceptable 4 8 Post production Information The MagQu Co Ltd will collect the relating information of post production such as customers complain expert s suggestions and the accident case of the similar product in marketing feedback in the risk management activities as ISO 14971 describing 4 9 Conclusion According to above risk management report the magnetic immunoassay analyzer XacPro S made by MagQu Co Ltd is safe enough and its potential risks are eliminated and its advantages are much more than its disadvantages and residual risks Fu da Prepared by Approved by y Dated 2014 12 10 48 6 Applicable Standards 6 1 Applied Standards for Low Voltage Directive and In Vitro Diagnostic Directive EN 61010 1 2010 Third Edition EN 61010 2 101 200
93. e manufacturer This information comprises the details on the label and the data in the instructions for use As far as practicable and appropriate the information needed to use the device safely must be set out on the device itself and or on the packaging for each unit or where appropriate on the sales packaging If individual packaging of each unit is not practicable the information must be set out in the leaflet supplied with one or more devices Instructions for use must be included in the packaging for every device By way of exception no such instructions for use are needed for devices in Class I or if they can be used safely without any such instructions Any symbol or identification colour used must conform to the harmonized standards In areas for which no standards exist the symbols and colours must be described in the documentation supplied with the device The label must bear the following particulars a the name or trade name and address of the manufacturer For devices imported into the Community in view of their distribution in the Community the label or the outer packaging or instructions for use shall contain in addition the name and address of the authorised representative where the Where appropriate this information should take the form of symbols 34 EN15223 1 2012 Directive 98 79 EC ENISO13485 2012 EN61010 1 2010 EN61010 2 101 2002 EN15223 1 2012 Directive 98 79 EC ISO 13485 20
94. e use of the device 2 1 Leakage current may cause EVEN pira 8 Electricit E cues 4 8 Not which transports power should be 2 4 5 mei Acceptable accessed by safety guild Acceptable 2 2 Surrounding temperature may 8 l 8 Set equipment into Heat influence measuring result Acceptable temperature controlled room The product will generate 2 4 magnetic field and the 8 Magnetic fields magnetic fields surround may Acceptable Use Aluminum disco smeldng influence measuring result 3 11 mor Soi PS 1 4 4 Bio hazard warning should be Bio burden recycling reagent may cause present bio burden P P 2 Elect tic will infl 8 Electromagnetic e a SS 8 1 Use Aluminum as a shielding eet eae measuring result Acceptable 42 Electromagnetic wave may be 4 Set equipment out of other Elec NA restrain by Aluminum 4 1 A bl equipments which work by shielding electromagnetic force 4 4 Every single part of product 16 8 Inadequate supply of E HD ed siut 4 4 which transports power should be 2 4 power quip ALARE accessed by safety guild Acceptable 4 7 Other devices which work by 4 Set equipment out of other Incompatibility with electromagnetic force may 2 2 equipments which work by influence measuring result and Acceptable other devices 1 py electromagnetic force 46 electromagnetic restraining 5 1 4 Write sufficient warning in the Ina
95. ecting those aspects a limitation of body dimensions Not a big equipment P b displays and indicators Readily to read P c accessibility and conventions of controls Readily to access P d arrangement of TERMINALS P lt 71402142 253 gt Page 39 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 17 RISK assessment N A RISK assessment conducted if HAZARD might arise and No hazards other than N A not covered by Clauses 6 to 16 addressed in Cl 6 to 16 TOLERABLE RISK achieved by iterative documented N A process covering the following a RISK analysis N A Identifies HAZARDS and estimates RISK N A b Risk evaluation N A Plan to judge acceptability of resulting RISK level N A based on the estimated severity and likelihood of a RISK c Risk reduction N A Initial RISK reduced by counter measures N A Repeated RISK evaluation without new RISKS N A introduced RISKS remaining after RISK assessment addressed in N A instructions to RESPONSIBLE BODY Information contained how to mitigate these RISKS N A Following principles in methods of RISK reduction N A applied by manufacturer in given order 1 Risks eliminated or reduced as far as possible N A 2 Protective measures taken for RISKS that cannot be N A eliminated 3 User information about residual RISK due to any N A defect of the protective measures In
96. ectromagnetic interference v 4 2 Electromagnetic restrain 4 3 Electromagnetic shoot 4 4 Inadequate supply of power 4 5 Inadequate supply of coolant 4 6 Likelihood of operation outside prescribed environmental conditions 4 7 Incompatibility with other devices 4 8 Accidental mechanical damage Y 4 9 Contamination due to waste products and or device disposal D5 Hazards related to the use of the device Available ot available Item Description Available N A 5 1 Inadequate labeling v 5 2 Inadequate operating instructions 5 3 Use by unskilled untrained personnel 5 4 Reasonably foreseeable misuse 5 5 Insufficient warning of side effects 5 6 Inadequate warning of hazards likely with re use of single use devices NISISIS 5 7 Incorrect measurements and other metrological aspects 5 8 Incompatibility with consumables accessories other devices V 5 9 sharp pointed Y D6 Hazards related to the user interface M Available Not available Item Description Available N A 6 1 confusing or missing instructions for use V 6 2 complex or confusing control system 6 3 slips laps and mistakes 6 4 poor mapping of controls to actions or of displayed informati
97. een ALARP White Acceptable 5 3 3 2 Rating scales means the risk level defined as following listed 10 8 Probability Severity 5 4 Assessment Result General principle Identification of possible hazards and contributing factors associated with medical device refer to ISO 14971 D2 Energy hazards Available Not available Item Description Available N A 2 Electricity Y 2 2 Heat Y 2 3 Mechanical force M 2 4 Magnetic fields Y 2 5 lonizing radiation 2 6 Non ionizing radiation 2 7 Moving parts 2 8 Non anticipates movement 2 9 Suspended masses 2 10 Patient support device failure 2 11 Pressure 2 12 Acoustic pressure 2 13 Vibration S SISISISISISIS D3 Biological hazards Available Not available Item Description Available N A 3 1 Bio contamination 3 2 Bio incompatibility NS 43 3 3 Incorrect formulation 3 4 Toxicity 3 5 Allergenicity 3 6 Mutagenicity 3 7 Carcinogenicity 3 8 Teratogenicity 3 9 Pyrogenicity 3 10 cross Infection NSISISISISISIS 3 11 Bio burden 3 12 Inability to maintain hygienic safety 3 13 Degradation NS D4 Environmental hazards M Available Not available Item Description Available N A 4 1 El
98. ensure that the changes have no negative impact on the established benefit risk profile of the addition of the substance in the medical device When the relevant medicines competent authority i e the one involved in the initial consultation has obtained information on the ancillary substance which could have an impact on the established benefit risk profile of the addition of the substance in the medical device it shall provide the notified body with advice whether this information has an impact on the established benefit risk profile of the addition of the substance in the medical device or not The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure Standard Sub clause s Report Document Comments Description Appli ca Standard Sub clause s ble or not The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device Special attention shall be given to substances which are carcinogenic mutagenic or toxic to reproduction in accordance with Annex I to Council Directive 67 548 EEC of 27 June 1967 on the approximation of laws regulations and administrative provisions relating to the classification packaging and labelling of dangerous substances 1 If parts of a device or a device itself intended to administer and or remove medicines body liquids or other su
99. equency range 1 Power or current See page 1 b Description of all input and output connections in accordance to 6 6 1 a Stated in the manual C RATING of insulation of external circuits in accordance to 6 6 1 b d Statement of the range of environmental conditions see 1 4 e Degree of protection IEC 60529 IP20 f ifimpact rating less than 5 J 5J is tested N A IK code in accordance to IEC 62262 marked or No IK code is marked N A symbol 14 of table 1 marked with N A lt 11402142 253 gt 9 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict RATED energy level and test method stated N A 5 4 3 Equipment transportation installation and assembly P instructions EN 61010 2 101 Documentation for the RESPONSIBLE BODY shall P include the following as applicable EN 61010 2 101 a instructions for transportation after delivery to the P RESPONSIBLE BODY EN 61010 2 101 b floor loading requirements EN 61010 2 101 c individual weights of principal heavy subassemblies EN 61010 2 101 d location and mounting instructions including the P space required for ventilation and for safe and efficient OPERATOR maintenance EN 61010 2 101 e assembly instructions EN 61010 2 101 Stated
100. ermanently N A connected equipment Overcurrent device N A Fitted within the equipment or N A Specified in manufacturer s instructions N A 9 6 3 Other equipment P Protection within the equipment Provided in the adapter P 10 EQUIPMENT TEMPERATURE LIMITS AND P RESISTANCE TO HEAT lt 11402142 253 gt 32 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 10 1 Surface temperature limits for protection against burns Easily touched surfaces within the limits in NORMAL and see Form A 21A in SINGLE FAULT CONDITION at an specified ambient temperature of 40 C Not exceed the values of P table 19 in normal condition or 105 C in single fault condition ambient 40 C for equipment rated above 40 C ambient temperature Rated 40 C N A limits not exceeded raised by the difference to 40 C Heated surfaces necessary for functional reasons No functional heated N A exceeding specified values surface is provided Are recognizable as such by appearance or N A function or Are marked with symbol 13 N A Guards are not removable without tool N A 10 2 Temperatures of windings Limits not exceeded in see Form A 21 NORMAL CONDITION Not exceed the vales of table 20 SINGLE FAULT CONDITION Not exceed the vales of P table 20 10 3 Other temperature measurements P Following measurements conducted if
101. es 5 1 8 N A Warning marking 5 2 2 Battery charging 13 2 2 N A Method Test agent Remains legible Label loose Curled edges Comments No Supplementary information Form A 4 P Agent A Water B Isopropyl alcohol 70 C specify agent D specify agent E specify agent Marking method see above N A lt 71402142 253 gt 44 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE Protection against electric shock Block diagram of systemForm A 5 P Pollution degree 12 Location Insulation Maximum CREEPAGE Distance type working NOTE 3 voltage description NOTE 1 NOTE 2 I CLEARANCE Test NOTE 3 voltage Comments Mains to 230Vac accessible parts GND Mains to 230Vac SELV NOTE 1 Type of insulation NOTE 2 Types of voltage NOTE 3 INSTALLATION CATEGORIES BI BASIC INSULATION Peak impulse test voltage pulse OVERVOLTAGE CATEGORIES DI DOUBLE INSULATION r m s Or POLLUTION DEGREES which differ from PROTECTIVE IMPEDANCE d c these should be shown under Comments RI Reinforced INSULATION peak SI Supplementary INSULATION Supplementary Information lt 71402142 253 gt Page 45 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict 6 2 TABLE List of ACCESSIBLE parts Fo
102. ex are imaged by using GE Healthcare Discovery ST4 PET CT scanner 2D mode 47 image planes 15 0 cm axial field of view for forty three subjects of normal controls MCI due to AD patients and early stage AD patients after injecting 370 555 MBq of This is so called PiB PET The detailed procedures of PiB PET are given in Ref 7 1 Meanwhile the ratio of plasma Ap1 42 to api 40 of each subject is detected by using Amyloid 1 42 and Amyloid 1 40 IMR reagents The typical PiB PET images and the corresponding plasma Ap1 42 0Ap1 40 s are shown in Fig 7 5 It was found that the plasma ratio increases Normal Early stage AD go PP 42 DA g1 40 0 40 0 00 Fig 7 5 PiB PET images for amyloid plaques on brain cortex and corresponding plasma 42 40 as more the amyloid plaques were imaged The plasma dagia4 api4o versus normalized amyloid plaques on brain cortex is shown in Fig 7 5 The normalized amyloid plaques on brain cortex is represented in terms of adjust predict value The results in Fig 7 6 show that a positive correlation correlation coefficient 0 67 exists for the relationship the plasma Af ratio and amyloid plaques on brain cortex All the details are reported in Ref 7 1 53 0 70 0 60 F 0 50 0 40 agi ag1 40 0 30 0 20 1 1 1 1 1 1 L 1 1 0 20 0 30 040 0 50 0 60 0 70 Adjusted predict value Fig 7 6 Plasma oagi 42 agi 4o Versus no
103. guishing MCI due to AD patients from early stage AD patients Instead the product of concentrations of plasma Ap 1 42 and tau protein i e OAp1 42Xtau can be a nice disgnostic parameter The distributions of the plasma 42 for MCI due to AD patients and early stage AD patients are shown in Fig 7 3 The plasma ap1 42X tar of MCI due to AD patients is smaller than that of early stage AD patients Through the receiver operating characteristic ROC curve analysis shown in Fig 7 4 the threshold of plasma api 42X tau for distinguishing MCI due to AD patients from AD patients is 643 96 pg ml which corresponds to 85 96 sensitivity and 84 specificity Early stage AD 12 n 32 amp t al 5 0 1 5 2 L MCI n 24 10r gu 1t 1 l 1 0 400 800 1200 1600 2000 pg ml Fig 7 3 Plasma api 42XQtau distribution for MCI due to AD patients and early stage AD patients assayed by using Amyloid 1 42 and Tau protein IMR reagents 52 Ap Tau 1 00 cut off 643 96 Sensitivity 0 85 Specificity 0 84 4 a Sensitivity 3 0 25 0 00 1 1 1 1 L 1 000 025 0 50 0 75 1 00 1 specificity Fig 7 4 ROC curve for finding the threshold of plasma ap1 42XQtau for distinguishing MCI due to AD from early stage AD 7 2 4 IMR Assay Results vs Medical Imaging 7 2 4 1 Plasma Ap Ratio vs PiB PET The amyloid plaques in brain cort
104. ients Meanwhile the plasma tau protein concentration increases The relationship between the scaled hippocampal volume and plasma tau protein concentration is plotted in Fig 7 8 A negative correlation with the coefficient of 0 61 is found for the relationship between the scaled hippocampal volume and plasma tau protein concentration 70 60 50r 40r 30 pg ml 20r 10 w L a 0 l 1 1 1 L 4000 6000 8000 10000 Scaled hippocampal volume mm Fig 7 8 Plasma tau protein concentration versus scaled hippocampal volume The plasma tau protein is assayed with Tau Protein IMR reagent Reference 7 1 Tzen S Y Yang Chen T W Cheng H E Horng H P Wen Y Y Huang C Y Shiu and M J Chiu Plasma but not tau related to brain PIB retention in early Alzheimer s disease ACS Neuro Chem 5 830 2014 7 2 M J Chiu Y F Chen Chen S Y Yang E P Gloria Yang T W Tseng J J Chieh J C Rare Chen K Y Tzen M S Hua and H E Horng Plasma tau as a window to the brain negative associations with brain volume and memory function in mild cognitive impairment and early Alzheimer s disease Human Brain Mapping 15 Oct 2013 55 Appendix A Declaration of Conformity Declaration of Conformity The following Type of product Magnetic Immunoassay Analyzer Designation XacPro S is herewith confirmed to comply with the require
105. ing 110 280 V 1 Frequency 50 60 Hz A 500 W VA Power in Current i Comments 2 1 Sample is operated with all parameters set at maximum setting Sample is operated with all parameters set at maximum setting Sample is operated with all parameters set at maximum setting 1 98 1 78 1 04 Sample is operated with all parameters set at maximum 01 1 Sample is operated with all parameters set at maximum setting 1 Sample is operated with all parameters set at maximum setting Note Measurements are only required for marked ratings 138 142 150 143 145 50 Supplementary information lt 11402142 253 gt 43 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict 5 3 TABLE Durability of markings Marking method see NOTE 1 Adhesive label 2 Ink printed 3 Laser marked 4 Film coated plastic foil control panel 5 Imprinted on plastic moulded in 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 N A terminals and operating devices 5 1 5 2 N A Switches and circuit breakers 5 1 6 2 Double reinforced equipment 5 1 7 N A Field wiring Terminal box
106. is Estimate risk s for each hazardous sttuahon sx4 4 Isrisk reductice necessary Rusk evaluation Identify appropristerist control measure recerdrisk control requirements 62 Implement record and Annnnnmessuresemes arme a Istheresidual risk acceptable Risk control z Arc all identified hazards considered risk evaluation Ove Review preductionpo Unacceptable 1 9 Fig 5 1 Flow chart of risk management for XacPro S 5 2 Question That Can Be Used to Identify Medical Device Characteristics That 39 Could Impact on Safety C 2 1 What is the intended use purpose and how is the medical device to be used Ans To measure the immunomagnetic reduction signal The reagent used in the test are also made by MagQu Co Ltd 2 2 Is the medical device intended to be implanted Ans No C 2 3 Is the medical device intended to be in contact with the patient or other person Ans Only contact with user C 2 4 What materials and or components utilized in the medical device or are used with or are in contact with the medical device Ans Magnetic fluid reagent and test samples C 2 5 Is energy delivered to and or extracted from the patient Ans No C 2 6 Are substances delivered to and or extracted from the patient Ans No 2 7 Are biological materials processed by medical device for subsequent re use transfusion or transplantation Ans No C 2 8
107. is mixed with the sample number of swirling magnetic beads in the reagent driven by external field is much fewer So the ac magnetic signal Of magnetic reagent will reduce due to the binding between bio molecules in the sample with magnetic beads that s why we call the detection method as magnetic reduction immunoassay detection Hereafter xac of magnetic reagent mixed with a sample is denoted with xac According to the description above more bi molecules the sample contains more bindings between magnetic beads and bi molecules will occur and more magnetic reduction will appear Thus we can detect amounts of bi molecule in the sample in reference to measurement on magnetic reduction of magnetic reagent Xac o b Xac 563 KT E t AR a ME Ms 97 E PR Aes TARY Xx SEARS NY xg ET 205 56 TAN Fig 2 2 Illustration of mechanism of immunomagnetic reduction to detect biotargets a Each magnetic nanoparticle oscillates individually with the applied alternative current magnetic field before binding with biotargets b Portions of magnetic nanoparticles become larger due to the binding with biotargets The bound magnetic nanoparticles in b contribute to the reduction in the alternative current magnetic susceptibility of the reagent To quantify the reduction in of magnetic reagent due to the binding between magnetic nanoparticles and bio
108. ist for Medical Directive 93 42 EEC Annex I Essential Requirement The following harmonized standard is applied to the essential requirement The all content shall be updated according to 93 42 EEC M5 2007 47 EC NISO13485 2012 Medical Devices Quality Management Systems NISO14971 2012 Medical devise Application of risk management to edical devices N15223 1 2012 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements B EN61010 1 2010 Safety requirements for electrical equipment for measurement control and laboratory use General requirements B EN61010 2 101 2002 Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility B EN61326 1 2006 Electrical equipment for measurement control and laboratory use EMC requirements General requirements B EN62304 2006 Medical device software Software life cycle processes B ENS55011 2009 Industrial scientific and medical equipment Radio frequency disturbance characteristics Limits and methods of measurement 13 Medical Devices Directive 93 42 EEC As amended by 2007 47 EC Product Description Product Medicinal Magnetic Immunoassay Analyzer O HSA Animal tissue Product class according to Medical Devices GMDN Code Directive Minor Class D Model type XacPro S P
109. l is connected in serious with the pick up coil the other end of the flux coupling coil is connected in serious with the sensor coil A high T superconducting quantum interference device SQUID magnetometer is used to detect the transferred magnetic signal at the sensor coil Thus the ac magnetic signal of reagent can be detected With the time evolution ac magnetic signal of reagent the IMR signal can be measured All the details of working principle of XacPro S are available in Refs 2 5 and 2 6 2 2 4 Hardware A picture to reveal the hardware of XacPro S is as shown in Fig 2 3 D Electronics Fig 2 3 Magnetic immunoassay analyzer XacPro S is consisted of three modules sensing part coils and electronics Briefly speaking XacPro S is consisted of three modules 1 Sensing part This part mainly contains a high T SQUID magnetometer and its controller a 5 L 10 L dewar and electromagnetically shielded can Coils Coils include excitation coils pick up coils flux coupling coil and sensor coil Sample is located inside excitation coils Electronics Electronics are consisted of a signal generator switches DAQ card and a computer The detailed specifications and dimensions of all the components are described in Chapter II of the Operation amp Maintenance Manual 2 3 Functional Feature The functional features of XacPro S are listed below Noise level lt 65 uV Hz at operating frequency Sign
110. lly N3E11 103R0454 018 Page 23 of 45 PMG i8 Th BE JR UT 30 5 fe TEL 886 4 2359 9009 ae FAX 886 4 2359 8847 Precision Machinery Research amp Development Center j www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC LOG SHEET OF ESD TEST Test Method Contact 1 Controller 2 Signal generator 3 Handle of door Level Result rer B Contact N R N R Note 1 N R means no requirement 2 Test points 2 1 air discharge for non conducted parts 2 2 contact discharge for conducted parts 2 3 mean the controller was reset N3E11 103R0454 018 Page 24 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA M RI ik A EA UR v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan 5 6 Photos during the test N3E11 103R0454 018 Page 25 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 6 Immunity Test of Radiated Radio Frequency Electromagnetic Field Amplitude Modulated 6 1 Test specification and performance criteria Phe omana Test Basic Test Performance Specification Standard Setup Criteria 80 1000 10 MHz V m Radio
111. ments set out in the Council Directive on the Approximation of the Laws of the Member States relating to the Low Voltage Directive 2006 95 EC and Electromagnetic Compatibility 2004 108 EC For the evaluation of above mentioned Directives the following harmonized European Standards or Technical Specifications were applied Standard Report No EN 61010 1 2010 Third Edition and T1402142 253 EN 61010 2 101 2002 EN 61326 1 2013 and N3E11 103R0454 018 EN 55011 2009 A1 2010 The following manufacturer is responsible for sole responsibility for this declaration Company Name MagQu Co Ltd Address No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Signature Sar Ah Z Z Print Name Shief Xoel len Title Pes foo C Date Place April 8 2014 Taiwan 56 Appendix B Certificate of Compliance with European Low Voltage Directive and In Vitro Diagnostic IVD Directive Certificate of Compliance With European Low Voltage Directive and In Vitro Diagnostic IVD Directive No T1402142 253 Type of equipment Magnetic Immunoassay Analyzer Certificate holder MagQu Co Ltd Type designation XacPro S Technical data 1 10 230 465 Qe p A sample of the equipm been tested in accor 2006 95 E C and In Vitr essential requirements o Standard used for showi i requirements of the directive Standard s est report s Issued by Date s gt Las kz N wa w j s 2 EN 61010 1 2
112. mild serve AD are shown in Fig 7 1 According to the results the 2 of normal controls is relatively lower than that of patients with either MCI due to AD or AD Through the receiver operating characteristic ROC curve analysis shown in Fig 7 2 the threshold of plasma 20r Mild Severe AD 10 L n 30 Early stage AD rj ithe n 32 MCI 15 ah n 24 0 l l Normal 10H n 109 0 0 00 0 40 0 80 1 20 1 60 OAs Portion Fig 7 1 Plasma oagi 42 bapi 4o distribution for normal controls MCI due to AD early stage AD and mild serve AD assayed by using Amyloid 1 40 Amyloid B1 42 IMR reagents 51 Ap 4 to Ap ao 1 00 0 75 A Cut ott 0 325 Sensitivity 0 94 050 Specificity 0 94 0 25 0 00 1 1 1 l 1 1 1 000 025 0 50 0 75 1 00 1 specificity Fig 7 2 ROC curve for finding the threshold of plasma ap1 42 ap1 40 for distinguishing MCI due to AD or AD from normal controls Ap1 42 0Ap1 40 for distinguishing MCI due to AD or AD from normal controls is 0 325 which corresponds to 94 sensitivity and 94 specificity 7 2 3 2 Product with Plasma 1 42 and Tau Protein for the Risk Evaluation of MCI In clinics it is very important to distinguish MCI due to AD patients from early stage AD patients The results in Fig 7 1 show that 42 1 40 is not a suitable diagnostic parameter for distin
113. molecules hereafter is defined as IMR 90 x 100 2 1 where IMR is referred as to IMR signal Furthermore IMR signal was found as function of the biomolecular concentration via logistic function 90 A B 2 2 1 9 where A B and y are finting parameters 2 2 3 Principle of Magnetic Immunoassay Analyzer XacPro S According the mechanism of IMR ac magnetic fields are applied to magnetic reagent The time evolution ac magnetic signal of magnetic reagent is detected Thus the magnetic immunoassay analyzer XacPro S is equipped with sets of excitation coils which generate ac magnetic fields to magnetize magnetic reagents A signal generator is used to applied ac current through the excitation coils Once magnetic reagent is placed inside excitation coils the reagent is magnetized An ac magnetic signal of reagent is induced To sense the induced ac magnetic signal of reagent a pick up coil is used as schematically shown in Fig 2 3 Then the sensed ac magnetic signal of Signal generator 1 f High T SQUID Signal generator 2 fo 9 a output C 1 Excitation coil 2 Flux coupling coil Sensor coil Excitation coil 1 Pick up coil Fig 2 3 Schematic configuration of XacPro S for detecting ac magnetic signal of magnetic reagent reagent is transferred to a magnetic sensor via a flux coupling coil One end of the flux coupling coi
114. moving parts Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices taking account of technical progress and of the means available for limiting vibrations particularly at source unless the vibrations are part of the specified performance Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted taking account of technical progress and of the means available to reduce noise particularly at source unless the noise emitted is part of the specified performance Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 31 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 The device can not work in the surroundings full of the noise Clause Description 12 7 4 Terminals and connectors to the electricity gas or hydraulic and pneumatic energy supplies which the user has to han
115. n 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Manufacturer MagQu Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Product Name Magnetic Immunoassay Analyzer Model Name XacPro S Serial No 5001 140401 Controller JSQ rf SQUID Magnetometer and rf SQUID Electronics with Touch Panel Controller Test Date 2014 03 11 and 2014 03 12 Standards EN 61326 1 2013 EN 55011 2009 A1 2010 Test Result PASS Test Laboratory PMC Electromagnetic Compatibility Testing Laboratory No 27 37 Road Taichung Industrial Park Taichung Taiwan TEL 886 4 2359 9009 886 4 2359 8847 Tested by Lee Hsin Chang sn MA March 14 2014 Signature Date Approved by Tim Hise Signature D Note 1 The test results only responds to the tested sample and is invalid as separately used 2 The test results are invalid without examination stamp and signature of this laboratory 3 The test results are not reproduced except in full without the written approved of PMC Lab N3EI1 103R0454 018 Page of 45 BOR OT RRP S Precision Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan Table of Contents 1 GENERAL DESCRIPTION OF EUIT Sr race wee TEL 886 4 2359 9009 FAX 886 4 2359 8847 WWW pmc org tw TG OF
116. n handling potentially infectious substances such as human samples or reagents the need to use protective gloves or other protective means EN 61010 2 101 k if the equipment could emit hazardous aerosol vapours in NORMAL USE instructions for protection of the mouth nose or eyes EN 61010 2 101 No vapour N A l if potentially hazardous visible or invisible radiation could be emitted instructions and requirements for protective devices such as protective glasses EN 61010 2 101 No radiation N A m a statement in the instructions that if the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired EN 61010 2 101 lt 11402142 253 gt 11 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Further requirements on instructions for use see EN 591 for IVD medical equipment for professional use EN 592 for self test IVD medical equipment EN 61010 2 101 Not a self test IVD N A 5 4 4 101 Self test IVD medical equipment EN 61010 2 101 Void 5 4 5 Equipment maintenance Instructions for RESPONSIBLE BODY include Instructions sufficient in detail permitting safe maintenance and inspection and continued safety The user s manual provided with the relevant statements Instruction against the use of detachable MAINS su
117. nfirm whether the product is grounded correctly before connecting the input and output terminal of the product Observe power of all terminals Please notice power and relevant mark of the product in order to prevent any risk of fire or electric shock Before connecting the product please read the product manual so as to further understand relevant power information Disconnect power Please refer to concerned instructions to confirm the position to disconnect the product from power Please do not hinder the power switch and it is accessible at any time when the product is in use Please do not operate before the cover is fitted on Please do not operate the product when the cover is taken off Be careful for refill liquid nitrogen and putting samples Please do not operate when doubting there is a fault If you doubt the product is damaged please allow qualified maintenance personnel to check it Prevent circuit exposed Please do not touch any exposed connector and component when the current is conveyed Please do not operate under a moist condition Please do not operate in the flammable and combustible air Please keep the product surface clean and dry Keep good ventilation Please refer to installation instructions of the manual for detailed information on how to install the product and provide it with good ventilation Other guild line Indoor use Altitude 2000 m Temperature 5 C to 40 C Humidity Maximum 80 RH at
118. ng Industrial Park Taichung Taiwan EMC LOG SHEET OF RE TEST IN RIGHT FRONT OF EUT VER 3m Trace QPLMT LA QP 300 1000 2000 3000 4000 5000 6000 7000 9000 10000 frequency No Freq Reading Corr Result Limit Margin MHz dBuV dB dBuV m dBuV m dB 1 30 000 26 818 18 644 45 462 50 000 4 538 2 37 275 26 925 15 043 41 968 50 000 8 032 3 46 975 24 882 9 929 34 810 50 000 15 190 4 131 850 23 294 12 373 35 667 50 000 14 333 5 144 725 21 358 11 743 33 100 50 000 16 900 6 267 650 22 447 13 752 36 199 57 000 20 801 7 291 900 25 295 13 892 39 187 57 000 17 813 N3E11 103R0454 018 Page 20 of 45 ki xk roz zl A E TEL 886 4 2359 9009 P4 NA co M RI ik A EA v FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Oroya No 27 37th Road Taichung Industrial Park Taichung Taiwan 4 6 Photos during the test N3E11 103R0454 018 Page 21 of 45 KA TEL 86 4 2359 9009 IIO Precision Machinery Research amp t Center oe 9 8847 No 27 37th Road Taichung Industrial Park Taichung Taiwan 5 Electrostatic Discharge Immunity Test 5 1 Test specification and performance criteria Test Basic Performance 4 Contact kV Enclosure EN 61000 4 2 Note 1 8Air Discharge Charge Voltage Note 1 The 4kV contact discharge shall be applied to conductive accessible parts Metallic contact
119. ng parts connected to MAINS supply P b TERMINALS carrying a current more than 0 5 A lt 0 5A N A Examination of material data or N A in case of doubt LI 1 Ball pressure test or N A 2 Vicat softening test of ISO 306 N A 11 PROTECTION AGAINST HAZARDS FROM FLUIDS P 11 1 Protection to OPERATORS and surrounding area P provided by EQUIPMENT All fluids specified by manufacturer considered P 11 2 Cleaning see Form A 24 P 11 3 Spillage see Form A 24 P If in NORMAL USE liquid is likely to be spilled into the P 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 EN 61010 2 101 11 4 Overflow see Form A 24 P 11 5 Battery electrolyte No battery N A Battery electrolyte leakage presents no HAZARD N A 11 6 Specially protected equipment see Form A 24 N A No IP rating 11 7 Fluid pressure and leakage N A 11 7 1 Maximum pressure see Form A 25 N A Maximum pressure of any part does not exceed P N A 11 7 2 Leakage and rupture at high pressure N A Fluid containing parts subjected to hydraulic test if see Form 25 N A lt 11402142 253 gt Page 34 of 69 EN 61010 1 EN 61010 2 101
120. nge of aa Frequency is marked for the adpater 2 with symbol 1 For the equipment b RATED supply voltage s or range 110 230V Max RATED power W or VA or input current See page 1 lt 71402142 253 gt 5 of 69 O EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict The marked value not less than 90 of the see Form A 3 P maximum value If more than one voltage range Single range N A Separate values marked or N A Values differ by less than 20 see Form A 3 N A d OPERATOR Set for different RATED supply voltages P Indicates the equipment set voltage Portable equipment indication is visible from the exterior Changing the setting changes the indication P e Accessory MAINS socket outlets accepting No mains socket outlet N A standard MAINS plugs are marked With the voltage if it is different from the MAINS N A supply voltage ee tes For use only with specific equipment N A If not marked for specific equipment it is marked N A with The maximum rated current or power or N A Symbol 14 with full details in the documentation N A 5 1 4 Fuses No operator replaceable N A fuse Operator replaceable fuse marking N A S68 9180520 u u text bonded 5 1 5 TERMINALS Connections and operating devices 5 1 5 1
121. ns of protection 6 6 Connections to external circuits 6 7 Insulation requirements see Annex K 6 10 2 Fitting of non detachable MAINS supply cords 9 2 a 2 Eliminating or reducing the sources of ignition within the equipment Lo 9 4 c Limited energy circuit 9 6 1 Overcurrent protection basic insulation between MAINS parts EN Testsite allitide it tete eine tees 1 500 m Test Test voltage co correction factor see Table 10 Location or Working voltage Test voltage Comments Verdict references from Forms A 2 V r m s peak d cV and A 5 Mains to Earth 230 1680Vac No break down Mains to accessible parts 230 3480Vac No break down Mains to secondary 230 3480Vac No break down Supplementary information 6 10 2 TABLE Cord anchorage Loc ation Mass kg Pull N Form A 15 Verdict Comment Verdict Torque Nm Dielectric strength test for 1 min 6 8 3 1 V r m s Supplementary information lt 11402142 253 gt 52 of 69 EN 61010 1 EN 61010 2 101 Requirement Test Result Remark Verdict 7 TABLE Protection against mechanical HAZARDS Form A 16 P 7 3 5 Gap limitations between moving parts 4mm Clause 7 3 5 1 Clause 7 3 5 2 Temporary Minimum gaps mm Maximum gaps mm Contact pr sure max 250 N Torso Head Leg Foot Toes Arm Hand Finger Head Fo
122. ntrol the emissions Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters Where devices are intended to emit potentially hazardous visible and or invisible radiation they must be fitted where practicable with visual displays and or audible warnings of such emissions Unintended radiation Devices shall be designed and manufactured in such a way that exposure of patients users and other persons to the emission of un intended stray or scattered radiation is reduced as far as possible Instructions The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation means of protecting the patient and the user and on ways of avoiding misuse of eliminating the risks inherent in installation Ionizing radiation Devices intended to emit ionizing radiation must be designed and manufactured in such a way as to ensure that where practicable the quantity geometry and quality of radiation emitted can be varied and controlled taking into account the intended use 27 Report Document Comments The device is a low voltage device and never generates high energy radiation The device is a low voltage device and never generates high energy radiation The device is a low voltage device and never generates high energy radiation The device is a low voltage device and never generates high ene
123. nufacture of Magnetic Immunoassay Analyzer This certificate is valid from 27 January 2014 until 27 January 2017 and remains valid subject to satisfactory surveillance audits Re certification audit due before 21 October 2016 Issue 1 Certified since 27 January 2014 Authorised by SGS United Kingdom Ltd Systems amp Services Certification Rossmore Business Park Ellesmere Port Cheshire CH85 UK tM 0 151 350 6656 f 44 0 151 350 6800 www sgs com SGS 13485 2 0612 This docurrerd amp i amp suec the Company subject jo it General Coadtoas of Cartfication Services access bie ot www 99s i Altemon drawn fo the fimtatioss cf Babi idem Vases estabished therein The authentic ion and of this document may be venfled amien Our Compan Directories asp Any usasthorived alteration forgery faisificafion of the content or appearance cf itis document is and offenders may be prosecuted to Ihe fullest extent of the lam 59 e V UKAS MANAGEMENT SYSTEMS 005 Appendix E Certification of ISO 9001 2008 Certificate TW14 10080 The management system of MagQu Co Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan R O C has been assessed and certified as meeting the requirements of ISO 9001 2008 For the following acties Design and Manufacture of non sterile magnetic beads for bio assay separation and
124. of 6 7 1 1 see Form A 5 P 6 7 1 5 Requirements for insulation according to type of circuit see Form A 5 P 6 7 2 MAINS Circuits of OVERVOLTAGE CATEGORY Il up CAT II and not over 300V P to nominal supply voltage of 300 V b 6 7 3 Secondary circuits separated from circuits Same as above P defined in a by transformer C K 1 MAINS circuits of OVERVOLTAGE CATEGORY III and CAT Il and not over 300V N A IV or OVERVOLTAGE CATEGORY II over 300 V d K 2Secondary circuits separated from circuits N A defined in c by transformer e Circuits having one or more of Insulation in N A circuits not addressed in 6 7 K 1 or K 2 and in measuring circuits where MEASUREMENT CATEGORIES do not apply 1 maximum TRANSIENT OVERVOLTAGE is limited to N A known level below the level of MAINS CIRCUIT 2 maximum TRANSIENT OVERVOLTAGE above the N A level of MAINS CIRCUIT 3 WORKING VOLTAGE is the sum of more than one N A circuit or a mixed voltage 4 WORKING VOLTAGE includes recurring peak N A voltage may include non sinusoidal or non periodic waveform 5 WORKING VOLTAGE with a frequency above N A 30 kHz 6 7 2 Insulation for MAINS CIRCUITS of OVERVOLTAGE CAT Il and not over 300V P CATEGORY II with a nominal supply voltage up to 300 V 6 7 2 1 CLEARANCES and CREEPAGE DISTANCES see Form A 13 P Values for MAINS CIRCUITS of table 4 are met CAT Il and not over 300V P Coatings to achieve reduction to POLLUTION DEGREE Pollution 2 is considered N A comply with
125. ollowing organizations and countries If you have any comments please don t hesitate to contact us Our contact information is as below PMC Testing Laboratory No 27 37 Road Taichung Industrial Park Taichung Taiwan TEL 886 4 2359 9009 312 FAX 886 4 2359 8847 N3E11 103R0454 018 Page 5 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 1 General Description of EUT 1 1 Description of EUT Test Location MagQu Co Ltd No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Production Name Magnetic Immunoassay Analyzer Model Name XacPro S Series No 001 140401 MQ Power Source 1 220Vac 60Hz Power Cord 2 0mm X3C Unshielded Power Cable 1 2 Operation procedures of the EUT Turn on Main Switch Turn on computer Launch SQUID software Click start button after samples are ready in sample region AR YN gt Continuous auto running 1 3 Description of worst case evaluation After estimating PMC have evaluated cycle running was taken would be the worst case for testing N3E11 103R0454 018 Page 6 of 45 dk cnt gt TEL 886 4 2359 9009 P4 M b RH B 26 BRT Fu D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center Or
126. on to actual state 6 5 controversial modes or mapping as SN lt lt S 44 compared to existing equipment 6 6 ambiguous or unclear presentation of m settings measurements or other information 6 7 misrepresentation of results 6 8 insufficient visibility audibility tactility Y 6 9 incompatibility with consumables accessories other medical v devices 6 10 incorrect measurement and other metrological aspects D7 Hazard arising from functional failure maintenance and aging M Available Not available Item Description Available N A 7 1 Inadequacy of performance characteristics for the intended use 7 2 Lack of or inadequate specification for maintenance including inadequate specification of post maintenance functional checks 7 3 nadequate maintenance v 7 4 Lack of adequate determination of device life time 7 5 Loss of mechanical integrity 7 0 Inadequate packaging SINIS 7 7 re use or improper re use 7 8 Functional Failure v 45 4 5 Measures to Eliminate The Risk amp Its Improvement 4 5 1 Failure Mode and Effect Analysis FMEA Potential Effects of Hazard Current Design Controls hazards ili i Probabilit Possible description WA RPN Recommended actions y Severity RPN hazards related to th
127. osed vii no damage which could cause spread of fire No damage 8 2 ENCLOSURE rigidity test 8 2 1 Static test 30 N with 12 mm rod to each part of ENCLOSURE in case of doubt test conducted at maximum RATED ambient temperature VU 8 2 2 Impact test v Impact applied to any part of ENCLOSURE causing a HAZARD if damaged lt 11402142 253 gt 29 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Impact energy level and corresponding IK code No IK coded N A Non metallic ENCLOSURES cooled to minimum RATED P ambient temperature if below 2 C 8 3 Drop test 8 3 1 Other than HAND HELD and DIRECT PLUG IN EQUIPMENT Floor standing equipment Tests conducted with a drop height or angle of Drop from 30 8 3 2 HAND HELD and DIRECT PLUG IN EQUIPMENT Floor standing equipment N A Non metallic ENCLOSURES cooled to minimum RATED N A ambient temperature if below 2 C Drop test conducted with an height of 1 m N A 8 101 Transport and storage EN 61010 2 101 P When packed in the manufacturer s packaging P equipment shall not cause a HAZARD during NORMAL USE after transport or storage in the conditions specified by the manufacturer see 5 1 101 and 5 4 101 EN 61010 2 101 9 PROTECTION AGAINST THE SPREAD OF FIRE 9 1 No spread of fire in NORM
128. ot Finger Verdict Comments max 50 N cm 500 180 120 50 120 100 25 120 35 Location max 150 N Enclosure Supplementary information lt 71402142 253 gt Page 53 of 69 2 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE Constructional requirements Form 18 Printed circuit boards Conditioning details Sample 1 Sample 2 Sample 3 Thickness of specimen Duration of flaming plus glowing After second application Supplementary information Printed circuit boards of material with a flammability classification of FV 0 min of IEC60707 or UL94 is used lt 11402142 253 gt 54 of 69 EN 61010 1 EN 61010 2 101 Requirement Test Result Remark Verdict TABLE Limited energy circuit Form 19 N A 9 4 a 9 4 b Current and power limitation Decision or Maximum potential in Maximum Maximum Overload Circuit Location circuit voltage available available protection separation Yes No Comments r m s d c current after 120 5 V A Supplementary information Not evaluated 9 5 TABLE Requirements for equipment containing or using flammable liquids Form A 20 N A Type of liquid 9 5 Flammable liquids Verdict b Quantity c Containment Supplementary information No flammable liquid
129. ot of push button type N A Symbol 9 and 15 used for on position N A Symbol 10 and 16 used for off position N A Pair of symbols 9 15 and 10 16 close together N A 5 1 7 Equipment protected by DOUBLE INSULATION or REINFORCED INSULATION Protected throughout symbol 11 used N A Only partially protected symbol 11 not used Class product P 5 1 8 Field wiring TERMINAL boxes No field wiring box N A If TERMINAL or ENCLOSURE exceeds 60 C see Form A 21A N A Cable temperature RATING marked N A Marking visible before and during connection or N A beside TERMINAL 5 1 101 Transport and storage 61010 2 101 Packaging shall be labelled to indicate any special P conditions for transport or storage EN 61010 2 101 5 2 Warning markings Visible when ready for NORMAL USE lt 11402142 253 gt Page 7 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Are near or on applicable parts P Symbols and text correct dimensions and colour a symbols min 2 75 mm and text 1 5 mm high and P contrasting in colour with background b symbols and text moulded stamped or engraved All by printing N A in material min 2 0 mm high and 0 5 mm depth or raised if not contrasting in colour N A If necessary marked with symbol 14 Symbol 14 is marked P Statement to isolate or disconnect the powe
130. oya No 27 37th Road Taichung Industrial Park Taichung Taiwan 2 General Information of Test 2 1 Summary of test result Standard Edition Comment EN 61326 1 2013 PASS EN 55011 2009 A1 2010 PASS Electro Maenetic Susceptibility Standard Edition Comment EN 61000 4 2 2009 PASS EN 61000 4 3 2006 A2 2010 PASS EN 61000 4 4 2004 A1 2010 PASS EN 61000 4 5 2006 PASS EN 61000 4 6 2009 PASS 2 2 Performance criteria of immunity test Performance Criterion The equipment shall continue to operate as intended without operator intervention No degradation of performance or loss of function is allowed below a performance level specified by the manufacturer when the equipment is used as intended The performance level may be replaced by a permissible loss of performance Performance Criterion B After the test the equipment shall continue to operate as intended without operator intervention No degradation of performance or loss of function is allowed after the application of the phenomena below a performance level specified by the manufacturer when the equipment is used as intended During the test degradation of performance is allowed However no change of actual operating state or stored data is allowed to persist after the test Performance Criterion Loss of function is allowed provided the function is self recoverable or can be restored by the operation of the control
131. pply cord with inadequate rating Specific battery type of user replaceable batteries No battery for user N A Any manufacturer specified parts Rating and characteristics of fuses Instructions include following subjects permitting safe servicing and continued safety a product specific RISKS may affect service personnel b protective measures for these RISKS c verification of the safe state after repair 5 4 6 Integration into systems or effects resulting from special conditions Aspects described in documentation 5 4 101 Removal of equipment from use for repair or disposal EN 61010 2 101 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 EN 61010 2 101 5 4 102 Transport and storage EN 61010 2 101 The manufacturer shall specify the conditions for transport and storage The documentation shall contain a specification of the permissible environmental conditions for transport and storage which shall be repeated on the outside of the packaging of the equipment see 5 1 EN 61010 2 101 PROTECTION AGAINST ELECTRIC SHOCK General see Form A 5 lt 11402142 253 gt Page 12 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Resul
132. quirement Test Result Remark Verdict screen bonding consists of directly connected N A structural parts or discrete conductors or both and withstands thermal and dynamic stresses see 6 5 2 2 a screen bonding with soldered connection see N A 6 5 2 2 b is Independently secured against loosening N A Not used for other purposes N A 6 5 3 SUPPLEMENTARY and REINFORCED INSULATION P meet CLEARANCE CREEPAGE DISTANCE and solid P insulation requirements of 6 7 6 5 4 PROTECTIVE IMPEDANCE see Form A 12 N A Limits current or voltage to level of 6 3 1 in NORMAL and No protective impedance is N A to level of 6 3 2 in SINGLE FAULT CONDITION used CLEARANCE CREEPAGE DISTANCE between terminations see Form A 13 N A of the impedance meet requirements of DOUBLE or REINFORCED INSULATION of 6 7 The protective impedance consists of one or more of see Form A 12 the following a appropriate single component suitable for safety N A and reliability for protection it is 1 RATED twice the maximum WORKING VOLTAGE N A 2 resistor RATED for twice the power dissipation for N A maximum WORKING VOLTAGE b combination of components N A Single electronic device not used as PROTECTIVE N A IMPEDANCE 6 5 5 Automatic disconnection of the supply No such device is used N A a RATED to disconnect the load within time specified N A in Figure 2 b RATED for the maximum load conditions of the N A equipment 6 5 6 Current or voltage limiting devices
133. r if access N A by using a tool to HAZARDOUS LIVE parts is permitted by user Advise how to avoid contact with HAZARDOUS live P parts EN 61010 2 101 Equipment that can be potentially infectious due to the Symbol 101 is marked P samples or reagents used shall be prominently marked with symbol 101 of Table 1 EN 61010 2 101 Equipment that can be hazardous due to the use of Symbol 14 is marked P chemical substances shall be marked with the appropriate symbol or if none is available symbol 14 of Table 1 EN 61010 2 101 Containers or bags for biohazardous waste material Symbol 101 is marked P which can be removed from the equipment during NORMAL USE shall be marked with symbol 101 of Table 1 EN 61010 2 101 Other warning markings are specified in 5 1 5 1 c Provided P 6 1 2 b 6 5 1 2 g 6 6 2 7 2 c 7 3 10 1 13 2 2 EN 61010 2 101 5 3 Durability of markings P EN 61010 2 101 Durability of markings the required markings remain see Form A 4 P clear and legible NORMAL USE EN61010 2 101 5 4 Documentation 5 4 1 General Accompanied by documentation for safety purposes Equipment is accompanied by documentation for P safety purposes for OPERATOR or RESPONSIBLE BODY EN 61010 2 101 Safety documentation for service personnel authorized P by the manufacturer Documentation necessary for safe operation is In printed media P provided in printed media or in electronic media if available at any time N A l
134. rface be used to initiate user action Ans Yes C 2 30 Dose the medical device use an alarm system Ans No C 2 31 In what way s might the medical device be deliberately misused Ans No C 2 32 Does the medical device hold data critical to patient care Ans No C 2 33 Is the medical device intended to be mobile or portable Ans No C 2 34 Dose the use of the medical device depends on essential performance Ans No 5 3 Risk Assessment Methodology Fills in the scoring from 1 10 in the blank space according to the anticipated harmful risk probability the grading standard is as follows The definition of happening probability is divided into following two kinds of considerations 5 3 1 Probability of Failures Definition Probability Rating Continues to occur 1 2 10 High occurs 1 20 8 Occasionally occur 1 200 6 Low occurs 1 2000 4 Hardly occurs 1 20000 2 Does not occur 0 1 5 3 2 Severity Definition Influence Rating High Cause to death 10 Medium High Cause to damage forever 8 Mrdium Low Cause to damage seriously 6 Low Cause to damage minor 4 Slightly Almost no damage 2 No risk No damage 1 5 3 3 Risk Priority Number RPN 5 3 3 1 RPN Probability Severity Risk Priority Number methodology is a 42 technique for analyzing the risk associated with potential problems identified during a Failure Mode and Effects Analysis FMEA Red Non acceptable Gr
135. rg tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 1 Overview of EUT 2 Overview of EUT N3E11 103R0454 018 Page 1 of 10 IM CP HJ KAA BARR RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 3 Overview of EUT 4 Overview of EUT N3E11 103R0454 018 Page 2 of 10 IM CP HJ KAA BART RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 www pinc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 5 Inside of EUT 6 Inside of EUT 1 1 N3E11 103R0454 018 Page 3 of 10 IM CP HJ KAA BARR RA RP TEL 886 4 2359 9009 Precision Machinery Research amp Development Center FAX 886 4 2359 8847 WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 7 Inside of EUT 1 2 8 Inside of EUT 1 3 eis i WAVE FACTORY Wey AA e N3E11 103R0454 018 Page 4 of 10 TEL 886 4 2359 9009 Cc RE FAX 886 4 2359 8847 Precision Machinery Research amp Development Center WWW pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan R O C 9 Inside of EUT 1 4 10 Inside of EUT 1 5 DTP DTP 25N Engano 85 12 VOC 1 0 8A y 1 14 msi is 0215 VOC 0 8A
136. rgy radiation Clause Description Appli ca Standard Sub clause s Report Document Comments ble or not 11 5 2 Devices emitting ionizing radiation intended for diagnostic radiology The device is a low shall be designed and manufactured in such a way as to achieve voltage device and appropriate image and or output quality for the intended medical tes hish purpose whilst minimizing radiation exposure of the patient and user never gener a es 1g energy radiation 11 5 3 Devices emitting ionizing radiation intended for therapeutic radiology The device is a low shall be designed and manufactured in such a way as to enable reliable 2 d voltage device and monitoring and control of the delivered dose the beam type and energy and where appropriate the quality of radiation never generates high energy radiation 1 XacPro S ver 201411 12 Requirements for medical devices connected to or equipped with Yes Directive 98 79 EC ISO 13485 Quality an energy source ENISO13485 2012 System Cert No ENISO14971 2012 TW14 10079 12 Devices incorporating electronic programmable systems must be EN55011 2009 designed to ensure the repeatability reliability and performance of EN61326 1 2006 _Design Verification and these systems according to the intended use In the event of a single EN61010 1 2010 Validation report fault condition in the system appropriate means should be adopted to EN61010 2 10 2002 No RD07 eliminate or reduce a
137. rification of compliance refers to the above mentioned product that is chosen to address the electromagnetic compatibility of EN 61326 1 2013 and EN 55011 2009 A1 2010 which also fulfils the requirements of the electromagnetic compatibility Directive 2004 108 EC this is to certify that the specimen is in conformity with the assessment requirement mentioned above this verification does not imply assessment of production of the product Verification No 103R0454 018 Test Report No N3E11 103R0454 018 Issued Date March 14 2014 Expires March 14 2017 Approved by PMC Address No 27 37 Road Taichung Industrial Park Taichung Taiwan R O C Tel 886 4 23599009 Fax 886 4 23598847 a AN Oy vo Wo lt SOR 58 P RT FRAIER PS d Precision Machinery Research amp Development Center www pmc org tw TEST REPORT NO N3E11 103R0454 018 ISSUE NO 1 EMC TEST REPORT TESTING OF MODEL XacPro S Magnetic Immunoassay Analyzer FOR MagQu Co Ltd Issued by Precision Machinery Research amp Development Center No 27 37 Road Taichung Industrial Park Taichung Taiwan Tel 886 4 23599009 Fax 886 4 23598847 TEL 886 4 2359 9009 IM y R RB PS FAX 886 4 2359 8847 Mwy Precision Machinery Research amp Development Center Sow tw No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC TEST REPORT Applicant MagQu Co Ltd 3F No 12 L
138. rm A 6 P 6 1 2 Exceptions 6 2 Determination of ACCESSIBLE parts Item Description Determination method Exception under 6 1 2 NOTE 5 NOTE 4 1 Enclosure V Rand J 2 Connector V Rand J NOTE 1 Test fingers and pins are to be applied without force unless a force is specified see 6 2 2 NOTE 2 Special consideration should be given to inadequate insulation and high voltage parts see 6 2 NOTE Parts 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 6 4 NOTE 4 Capacitor test may be required see Form 7 NOTE 5 The determination methods are V visual R rigid test finger J jointed test finger P3 pin 3 mm diameter P4 pin 4 mm diameter Supplementary information lt 11402142 253 gt 46 of 69 61010 1 61010 2 101 Requirement Result Remark Verdict 6 TABLE Values in NORMAL CONDITION Form A 7 P 6 1 2 Exceptions 11 2 Cleaning and decontamination 6 3 1 Values in NORMAL CONDITION see NOTE 1 113 Spillage 6 6 2 Terminals for external circuit 11 4 Overflow 6 10 3 Plugs and connections Voltage Current Capacitance 10s 5s test NOTE Comments see V V V Test mA mA mA Form A 6 r m s d c circuit r m s peak d c uC mJ V uC mJ A1 A2 A3 1 lt 2 lt 2 lt 0 1 39 Mains switch ON 2 lt 2 lt 2 lt 0
139. rmalized amyloid plaques on brain cortex The plasma jAB1 42 and dapi 4o are assayed with Amyloid 1 42 and Amyloid 1 40 IMR reagents The normalized amyloid plaques on brain cortex is represented in terms of adjusted predict value 7 2 4 2 Plasma Tau protein Concentration vs MRI The AD patients are usually accompanied with the atrophy of hippocampus which causes the express of tau protein in cerebrospinal fluid The tau protein concentration in plasma would be varied due to the atrophy of hippocampus Thus the relationship between the plasma tau protein concentration and hippocampal volume is investigated The hippocampal volumes of normal persons n 30 MCI due to AD patients n 20 and early stage AD patients n 10 are measured by using 1 5 T magnetic resonance imaging MRI scanner EXCITE General Electric Milwaukee USA The detailed procedures of MRI are described in Ref 7 2 For each case the hippocampal volume is scaled to the whole brain volume The plasma tau protein concentrations of these subjects are detected by using Tau Protein IMR Reagent The typical MR images and the corresponding tau protein concentrations are shown in Fig 7 7 It was found that atrophy of the hippocampus Normal MCI MCI Early stage AD hippocampus 50 0 pg ml 25 0 0 0 Fig 7 7 MR images for hippocampal volumes and corresponding plasma tau protein concentration 54 occurs for MCI due to AD and early stage AD pat
140. roduct Description including intended use The Magnetic Immunoassay Analyzer XacPro S designed by MagQu Co Ltd is used to measure the change in the ac magnetic susceptibility of a sample over time If the sample is a mixture of a magnetic reagent and an object to be detected it can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility Manufacturer pls stamp Company MagQu Co Ltd Address No 12 Lane 538 Zhongzheng Rd Xindian Dist New Taipei City Taiwan Postal address 231 Conformity Assessment Procedure according to the following Annex of the Directive 93 42 EEC pls tick LlAnnexII Oincl O excl section4 Annex V 14 Signature The manufacturer confirms that all information given in the checklist is correct The Lead Auditor confirms that the documents referred to in this checklist are implemented in the QS which has been assessed to determine conformity with the directive 93 42 EEC The MD Expert confirms that the product documentation is according to the requirements in directive 93 42 EEC 15 Appli ca Standard Sub clause s ble or not Report Document Description General requirements Comments The devices must be designed and manufactured in such a way that when used under the conditions and for the purposes intended they will not compromise the clinical condition or the safety of patients or the s
141. rt are enclosed N A Access to HAZARDOUS moving parts permitted under following circumstances N A lt 11402142 253 gt 26 of 69 EN 61010 1 EN 61010 2 101 O automatic means or Clause Requirement Test Result Remark Verdict a obviously intended to operate on parts or materials Not operate outside the N A outside of the equipment equipment inadvertent touching of moving parts minimized by N A equipment design e g guards or handles b If operator access is unavoidable outside normal N A use following precautions have been taken 1 Access requires TOOL Access is not possible N A without the use of a tool 2 Statement about training in the instructions N A 3 Warning markings on covers prohibiting access N A by untrained operators 14 with full details in documentation N A 7 3 3 RISK assessment for mechanical HAZARDS to body parts Moving part are enclosed N A RISK is reduced to a tolerable level by protective N A measures as specified in Table 12 Minimum protective measures A Low level measures N A B Moderate measures N A C Stringent measures N A 7 3 4 Limitation of force and pressure see Form A 16 N A Following levels are met in normal and single fault Moving part are enclosed N A condition Continuous contact pressure below 50 N cm with N A force below
142. s external electrical influences electrostatic discharge pressure or variations in pressure acceleration thermal ignition sources etc m adequate information regarding the medicinal product or products which the device in question is designed to administer including any limitations in the choice of substances to be delivered n precautions to be taken against any special unusual risks related to the disposal of the device o medicinal substances or human blood derivatives incorporated into the device as an integral part in accordance with Section 7 4 p degree of accuracy claimed for devices with a measuring function q date of issue or the latest revision of the instructions for use Note Please see Appendix B and C to get further information 38 5 Risk Management Product name Magnetic Immunoassay Analyzer Product code XacPro S Version 2014 04 In general this risk assessment report for XacPro S made by MagQu Co Ltd was carried out in accordance with the requirements of ISO 14971 2007 and ISO 62304 2006 in which an explicit risk assessment procedure has been described The detailed assessment was made according to the requirement and the relevant annexes set out on the standards 5 1 Risk Management Flow Chart The flow chart is shown in Fig 5 1 Flow Ventication 18014971 2007 Intendeduse Identify characteristics 4 2 Identify known ce foreseeable hazards 4 3 Risk analys
143. s suck as in battery compartments or in socket outlets are excluded from this requirement 5 2 Test setup Metallic EUT part Conductive adhesive copper foil lonizer IEC 1808 2000 N3E11 103R0454 018 Page 22 of 45 E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 5 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 24 6 C 53 8 1012 mbar 5 4 Description of the test 1 Discharges were carried out both by conduct and through the air at vulnerable points likely to easily touched or approached point on the operator s panel and loading unloading area of EUT For each test increasing severity until the required level was reached according to the standard did the discharge 2 For each test point ten discharges were done 3 The performance was observed according to the intentional movement defined by the manufacturer and any discrepancies were noted 4 The test was repeated when the EUT was in idle standby state 5 5 Test result The following pages show the process of testing in both auto mode and idle state It can be seen that there were no unintentional movement on the EUT And according to the standard the test was passed successfu
144. s by the user in accordance with the manufacturer instructions N3E11 103R0454 018 Page 7 of 45 Precision Machinery Research amp Development Center No 27 37th Road Taichung Industrial Park Taichung Taiwan 2 3 Test equipment ROHDE amp SCHWARZ EMI Test Receiver ESCS 30 847793 004 18 Jul 2014 CHASE Bilog Antenna CBL 6111B 2085 30 Jun 2014 SCHWARZBECK MESS ELEKTRONIK 8129129 02 Jan 2015 NNLK8129 Power Clamp 848818 012 19 Jan 2015 TEST DPA 500 V0503100065 10 Nov 2014 Flicker Analyzer ESD Test Unit EM TEST ESD 30C V0822103834 03 Jul 2014 ROHDE amp Signal Generator SCHWARZ SMYOI 844934 058 31 Oct 2014 Signal Generator 4037003276 02 Jan 2015 ignal Ge 8648C Jan Power Amplifier KALMUS 747LC 8680 1 20 Dec 2014 EFT Test Unit EM TEST EFT 500 0596 32 04 Jul 2014 EM TEST VCS 500 0397 09 04 Jul 2014 6 dB Attenuator BNOS ELECTRONICS 522055 20 Dec 2014 Power Fail Simulator EM TEST PFS 503 0897 03 10 Nov 2014 N3E11 103R0454 018 Page 8 of 45 WWW pmc org tw PMG B BE EAS SE PRR RB TEL 886 4 2359 9009 886 4 2359 M Ko Precision Machinery Research amp Dev Center S847 No 27 37th Road Taichung Industrial Park Taichung Taiwan PFMF Generator EM TEST MC26100 f 10 Jun 2014 Mmmm Tama Tama uu ws r N3E11 103R0454 018 Page 9 of 45 OM Precision
145. s far as possible consequent risks _Risk Management Report No RM07 02 Product user Manual 28 Clause Description Appli ca Standard Sub clause s ble or not 12 1 a For devices which incorporate software or which are medical software Yes Directive 98 79 EC in themselves the software must be validated according to the state of ENISO13485 2012 the art taking into account the principles of development lifecycle risk ENISO14971 2012 management validation and verification EN62304 2006 Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply supply must include an alarm system to signal any power failure Devices where the safety of the patients depends on an external power 12 2 12 3 2 4 user of situations which could lead to death or severe deterioration of 1 Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the the patient s state of health 29 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Design Verification and Validation report No RD07 Risk Management Report No RM07 02 Product Research files XacPro S The device never directly touches patients in any material or energy pathway which can be imagined The device never directly touches patients in any material or energy pathway which
146. s measures for protection N A 12 5 2 Ultrasonic pressure see Form A 27 N A Equipment not intended to emit ultrasound does not No ultrasonic pressure N A exceed limit of 110 dB between 20 kHz and 100 kHz Equipment intended to emit ultrasound N A Outside useful beam does not exceed limit of 110 dB N A between 20 kHz and 100 kHz If inside useful beam above values exceeded N A Marked with Symbol 14 of Table 1 N A and following information in the documentation a dimensions of useful beam N A b area where ultrasonic pressure exceed 110 dB N A maximum sound pressure inside beam area N A 12 6 Laser sources No laser source N A Equipment meets requirements of IEC 60825 1 N A 13 PROTECTION AGAINST LIBERATED GASES N A EXPLOSION AND IMPLOSION lt 11402142 253 gt 36 of 69 61010 1 61010 2 101 Clause Requirement Test Result Remark Verdict 13 1 Poisonous and injurious gases No such gases N A No poisonous or injurious gases or substances N A liberated in NORMAL CONDITION Attached data test reports demonstrate conformity N A Equipment shall not liberate dangerous amounts of N A poisonous or injurious gases or substances in NORMAL CONDITION or in SINGLE FAULT CONDITION EN 61010 2 101 If potentially hazardous substances are used in the N A equipment the OPERATOR shall not be wetted nor be able to inhale q
147. s so called immunomagentic reduction The details of XacPro S are described in this report 2 2 General Description 2 2 1 Outward Appearance of XacPro S The picture of XacPro S is shown in Fig 2 1 XacPro S is 2 35 m in width 0 95 m in depth and 1 2 m in height The input electricity is 100 230 VAC 50 60Hz Fig 2 1 Photo of magnetic immunoassay analyzer XacPro S 2 2 2 Mechanism of Immunomagnetic Reduction The Magnetic Immunoassay Analyzer XacPro S utilizes so called immunomagnetic reduction IMR as its assay principle The theoretical derivation of IMR is given in Refs 2 1 2 4 The conceptual description of immunomagnetic reduction is illustrated as follows Under external ac magnetic fields of which frequencies range from tens to millions of hertz individual magnetic beads in a magnetic reagent will be driven by the external ac magnetic fields and swirl The magnetic reagent produces ac magnetic signals Yac accordingly Hereafter the of pure magnetic reagent is referred as to as shown in Fig 2 2 When the magnetic reagent is mixed with the sample containing to be detected bio molecules bio molecules will bind with magnetic beads via bioprobes e g antibodies on surface of the magnetic beads In this way part of magnetic beads in the reagent will get enlarged even many magnetic beads will gather together In such case compared with the number of swirling magnetic beads before the magnetic reagent
148. se a danger Devices must incorporate suitable means to prevent as far as possible the accidental release of dangerous levels of energy from an energy and or substance source Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61010 2 101 2002 EN 62304 2006 The function of the controls and indicators must be clearly specified on the devices Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system such information must be understandable to the user and as appropriate the patient Directive 98 79 EC ENISO13485 2012 EN61010 1 2010 EN61010 2 101 2002 Information supplied by the manufacturer Each device must be accompanied by the information needed to use it safely and properly taking account of the training and knowledge of 23 Report Document Comments The device never directly touches patients in any material or energy pathway which can be imagined The device never directly touches patients in any material or energy pathway which can be imagined ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 _Risk Management Report No RM07 02 Product research files XacPro S Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 Clause Description Appli ca Standard Sub clause s ble or not the potential users and to identify th
149. t Remark Verdict 6 1 1 Requirements Protection against electric shock maintained in NORMAL CONDITION and SINGLE FAULT CONDITION In normal and single fault condition not hazardous live ACCESSIBLE parts not HAZARDOUS LIVE Conform with the request Voltage current charge or energy below the limits in NORMAL CONDITION and in SINGLE FAULT CONDITION between ACCESSIBLE parts and earth two ACCESSIBLE parts on same piece of the equipment within a distance of 1 8 m Conformity is checked by the determination of 6 2 and 6 3 followed by the tests of 6 4 to 6 11 Exceptions Following HAZARDOUS LIVE parts may be accessible to an OPERATOR No hazardous live part is accessible N A a parts of lamps and lamp sockets after lamp removal No HV lamp N A b parts to be replaced by operator only by the use of tool and warning marking No tool is needed N A Those parts not HAZARDOUS LIVE 10 s after interruption of supply see Forms A 6 N A Capacitance test if charge is received from internal capacitor see Forms A 6 and A 7 N A 6 2 Determination of accessible parts see Form A 6 6 2 1 General Unless obviously determination of accessible parts as specified in 6 2 2 to 6 2 4 6 2 2 Examination with jointed test finger as specified B 2 Complied with the finger test with rigid test finger as specified B 1
150. t 11402142 253 gt Page 8 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Documentation includes a intended use The user s manual provided with the relevant safety statements o technical specification O name and address of manufacturer or supplier Information specified in 5 4 2 to 5 4 6 2 a information to mitigate residual RISK accessories for safe operation of the equipment specified U Ul g guidance provided to check correct function of the equipment if incorrect reading may cause a HAZARD from harmful or corrosive substances of HAZARDOUS live parts h instructions for lifting and carrying Warning statements and a clear explanation of warning symbols Provided in the documentation or Stated in manual Information is marked on the equipment 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 EN 61010 2 101 Stated in the manual 5 4 2 Equipment ratings Documentation includes a Supply voltage or voltage range 110 230V Frequency or fr
151. t Comments ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 ISO 13485 Quality System Cert No TW14 10079 _Risk Management Report No RM07 02 Product user Manual XacPro S ver 201411 Description Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion during normal use and in single fault condition Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to sub stances which could cause combustion Devices with a measuring function Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device The limits of accuracy must be indicated by the manufacturer Appli ca Standard Sub clause s ble or not Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 EN15223 1 2012 Directive 98 79 EC ENISO13485 2012 EN62304 2006 25 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 _Product Master file No MF07 _Risk Management Report No RM07 02 ISO 13485 Quality System Cert No TW14 10079 _Product Master file No MF07 _Risk Management Report No RM07 02 Product user Manual
152. tandard Sub clause s Infection and microbial contamination The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient user and third parties The design must allow easy handling and where necessary minimize contamination of the device by the patient or vice versa during use Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues Notified bodies shall retain information on the geographical origin of the animals Processing preservation testing and handling of tissues cells and substances of animal origin must be carried out so as to provide optimal security In particular safety with regard to viruses and other transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process Devices delivered in a sterile state must be designed manufactured and packed in a non reusable pack and or according to appropriate procedures to ensure that they are sterile when placed on the market and remain sterile under the storage and transport conditions laid down until the protective packaging is damaged or opened 22 Report Document Comments The device never directly touches patients or operators in any biological pathway which can be imagine
153. th full information in the documentation Tested with 5J N A For non metallic ENCLOSURES rated below 2 C ambient temperature value chosen for minimum rated temperature N A Impact energies between IK values the IK code marked for nearest lower value N A Conformity is checked by performing following tests 1 static test of 8 2 1 2 impact test of 8 2 2 with 5 J except for HAND HELD EQUIPMENT if impact energy not selected to 5 J alternate method of IEC 62262 used N A 3 drop test of 8 3 1 or 8 3 2 except for FIXED and EQUIPMENT with mass over 100 kg Fixed equipment N A Equipment rated with an impact rating of IK 08 that obviously meets the criteria Not so rated N A After the tests inspection with following results HAZARDOUS LIVE parts above the limits of 6 3 2 not ACCESSIBLE insulation pass the voltage tests of 6 8 see Form A 24 i no leaks of corrosive and harmful substances ii ENCLOSURE shows no cracks resulting in a HAZARD No cracks which could cause a hazard iii CLEARANCES not less than their permitted values No less than their permitted values and the insulation of internal wiring remain undamaged iv insulation of internal wiring remains undamaged No damage v PROTECTIVE BARRIERS not damaged or loosened No damaged or loosened vi No moving parts exposed except permitted by 7 3 No moving parts exp
154. that the EUT would pass the test to the limits N3E11 103R0454 018 Page 11 of 45 DNG No 27 37th Road Taichung Industrial Park Taichung Taiwan MEZA PRM ERA PS Precision Machinery Research amp Dev Center EMC LOG SHEET OF CE TEST L PHASE TEL 886 4 2359 9009 FAX 886 4 2359 8847 WWW pmc org tw EET peer Freq Read Read Con Result Result Limit Limit Margin Margin No MHz AV QP dB AV QP AV QP AV QP dBuV dBuV dBuV dBuV dBuV dBuV dB dB 1 0 282 50 630 52 589 10 050 60 679 62 638 66 000 79 000 5 321 16 362 2 0 417 50 675 55 055 10 059 60 734 65 114 66 000 79 000 5 266 13 886 3 0 558 46 788 55 168 10 066 56 854 65 234 60 000 73 000 3 146 7 766 4 0 697 39 921 50 103 10 073 49 994 60 176 60 000 73 000 10 006 12 824 5 1 353 35 913 50 546 10 122 46 035 60 668 60 000 73 000 13 965 12 332 6 2 167 34 717 42 763 10 188 44 905 52 951 60 000 73 000 15 095 20 049 N3E11 103R0454 018 Page 12 of 45 dei o amp Dev UR Center No 27 37th Road Taichung Industrial Park Taichung Taiwan EMC LOG SHEET OF CE TEST N PHASE TEL 886 4 2359 9009 FAX 886 4 2359 8847 WWW pmc org tw Amplitude 5 ee 7 ee Vel ua
155. their performance is maintained in accordance with the intended use Appli ca Standard Sub clause s ble or not 19 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 Report Document Comments ISO 13485 Quality System Cert No TW14 10079 Product Master file No MF07 Product user Manual XacPro S ver 201411 Clause Description Where a device incorporates as an integral part a substance which if used separately may be considered to be a medicinal product as defined in Article 1 of Directive 2001 83 EC and which is liable to act upon the body with action ancillary to that of the device the quality safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001 83 EC For the substances referred to in the first paragraph the notifie shall having verified the usefulness of the substance as part of medical device and taking account of the intended purpose of t device seek a scientific opinion from one of the competent aut designated by the Member States or the European Medicines body the orities gency EMEA acting particularly through its committee in accordance with Regulation EC No 726 2004 1 on the quality and safety of tl substance including the clinical benefit risk profile of the incorporation of the substance into the device When issuing its opinion the competent authori
156. ts standard 30 MHz 230 MHz 40 dB uV m quasi peak 50 dB uV m quasi peak measured at 10m distance measured at 3m distance Enclosure EN 55011 230 MHz 1000 MHz 47 dB uV m quasi peak 57 dB uV m quasi peak measured at 10m distance measured at 3m distance 4 2 Test setup 3m EMI Test N3E11 103R0454 018 Page 15 of 45 Receiver E Pe che lk P ee TEL 886 4 2359 9009 2 M ib H Bj 35 PET AUR FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 4 3 Environmental conditions Test Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 11 2014 24 8 C 55 5 1018 mbar 4 4 Description of the test 1 The receiving antenna was set 3 meters in front and right front of EUT was mounted on the tripod The height of the antenna was 1 8m above the ground Measurement was made with the antenna having both horizontal and vertical polarities 2 We found the worse case on the front side of electronic box and recorded the measurement results 4 5 Test result The following pages show the results with antenna having both horizontal and vertical polarities And the following table shows quasi peak values in some certain frequency ranges which are local maximums in the curves Judging from these data is reasonable to assume that the EUT would pass the test to the limits N3E1
157. two layers are separated by Same as above N A applicable CLEARANCES and CREEPAGE DISTANCES REINFORCED INSULATION have adequate electric N A strength one of following methods used a thickness at least 0 4 mm N A b insulation is assembled of min two separate layers N A each RATED for test voltage of Table 5 for BASIC INSULATION c insulation is assembled of min three separate see Form A 14 N A layers where the combination of two layers passed voltage tests of 6 8 3 with values of Table 5 for REINFORCED INSULATION 6 7 3 Insulation for secondary circuits derived from MAINS of P OVERVOLTAGE CATEGORY II up to 300 V 6 7 3 1 Secondary circuits where separation from MAINS CIRCUITS is achieved by a transformer providing lt 11402142 253 gt Page 21 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict REINFORCED INSULATION P DOUBLE INSULATION P screen connected to the PROTECTIVE CONDUCTOR No such parts N A TERMINAL 6 7 3 2 CLEARANCES a meetthe values of Table 6 for BASIC INSULATION and SUPPLEMENTARY INSULATION twice the values of Table 6 for REINFORCED P INSULATION or b pass the voltage tests of 6 8 with values of see Form A 14 N A Table 6 with following adjustments 1 values for REINFORCED INSULATION 1 6 times with the R I test N A the values for BASIC INSU
158. ty or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as Where a device incorporates as an integral part a human bloo usefulness of the substance as part of the medical device and taking into account intended purpose of the device seek a scientific opinion from tl etermined by the notified body derivative the notified body shall having verified the the EMEA acting particularly through its committee on the quality and safety of the substance including the clinical benefit risk profile of the incorporation of the human blood derivative into the device W issuing its opinion the EMEA shall take into account the manu of incorporation of the substance into the device as determined Where changes are made to an ancillary substance incorporates en facturing process and the data related to the usefulness by the notify body ina device in particular related to its manufacturing process the notified body shall be informed of the changes and shall consult the relevant medicines competent authority i e the one involved in the initial consultation in order to confirm that the quality and safety of the ancillary substance are maintained The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body in order to
159. u D h FAX 886 4 2359 8847 Precision Machinery Research amp Development Center www pino No 27 37th Road Taichung Industrial Park Taichung Taiwan 10 Immunity Test of Radiated Radio Frequency Electromagnetic Filed Pulse Modulated 10 1 Test specification and performance criteria Test Basic Performance Phenomena VER Specification Standard Criteria Radio Frequency 900 e MHz Electromagnetic 2 4 GHz ENV 50204 Field 10 V M Pulse Modulated Unmodulated rms Note 1 The frequency Trasmitted frequency 890 915MHz Receiving frequency 935 960 MHz Note2 This test was replaced with actual licensed transmitter MOTOROLA W220 The specification was described in section 7 4 Note3 The Wireless Router is to be used for RS testing at the fixed frequency 2 4GHz 10 2 Test setup EUT Mobile Phone Wireless Router N3E11 103R0454 018 Page 42 of 45 KA TEL 886 4 2359 9009 886 4 884 Precision Machinery Research amp Dean Center www pmc org tw No 27 37th Road Taichung Industrial Park Taichung Taiwan 10 3 Environmental conditions TestDate Date Ambient Temperature Relative Humidity Atmospheric Pressure Mar 12 2014 24 6 C 53 8 1012 mbar 10 4 Description of the test 1 The field strength of the mobile phone and wireless router were measured by the EMI test receiver We found the distance to the antenna where the fiel
160. uantities likely to be hazardous The areas of the equipment containing such substances shall be equipped with protective covers or similar means of protection EN 61010 2 101 13 2 Explosion and implosion Components not likely to N A explode in overheated 13 2 1 Components N A Components liable to explode Pressure release device provided or N A Apparatus incorporates operator N A protection see also 7 7 Pressure release device Discharge without danger N A Cannot be obstructed N A 13 2 2 Batteries and battery charging see Form A 28 N A If explosion or fire HAZARD could occur No battery Protection incorporated in the equipment or N A Instructions specify batteries with built in protection N A In case of wrong type of battery used No HAZARD Of N A Warning by marking and within instructions N A Equipment with means to charge rechargeable batteries Warning against the charging of non rechargeable N A batteries and Type of rechargeable battery indicated or N A Symbol 14 used N A Battery compartment design N A Single component failure N A lt 11402142 253 gt Page 37 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict Polarity reversal test N A 13 2 3 Implosion of cathode ray tubes No cathode ray tubes is N A used If maximum face dimensions gt 160 mm
161. ve dose rate of radiation measured If dose rate exceeds 5 uSv h marked with the following N A a Symbol 17 ISO 361 N A b Abbreviations of the radionuclides N A c With maximum dose at 1 m or N A lt 11402142 253 gt Page 35 of 69 EN 61010 1 EN 61010 2 101 Clause Requirement Test Result Remark Verdict with dose rate value between 1 uSv h and 5 uSv h N A I T eine 12 2 1 3 Equipment not intended to emit radiation N A Limit for unintended stray radiation of 1 uSv h at any N A easily reached point kept 12 2 2 Accelerated electrons No accelerated electrons N A Compartments opened only by the use of a TOOL N A 12 3 Ultraviolet UV radiation No ultra violet radiation N A No unintentional HAZARDOUS escape of UV radiation checked by inspection and N A evaluation of RISK assessment documentation N A 12 4 Micro wave radiation No micro wave generator N A Power density does not exceed 10 W m N A 12 5 Sonic and ultrasonic pressure No such pressure N A 12 5 1 Sound level see Form A 27 N A No HAZARDOUS sound emission N A Maximum sound pressure level measured and N A calculated for maximum sound power level as specified in ISO 3746 or ISO 9614 1 Instruction describe

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