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1. Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No A3 of A6 te Q CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 Temperature Box Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No A4 of A6 ae CERPASS TECHNOLOGY CORP Report No TEEX1303269 C I ee Bi Y i M CER ERD OS x j DOLY x y d es XX 2d Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No Ab of A6 w C Cc 5 CERPASS TECHNOLOGY CORP Report No TEEX1303269 ee er Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No A6 of A6 Chapter 6 Clinical Evaluation Report Performance Evaluation Clinical Data 1 Subjects 24 serum samples from healthy subjects Normal control and 30 serum samples from patients with colorectal cancer CRC were used for the IMR CEA assay The CEA concentrations in human serum samples will be determined using the IMR signals CRC patients were identified using either pathological evidence or an immunoassay All of the enrolled patients provided informed consent before undergoing the procedure and this study was approved by National Taiwan University Hospital Research Ethics Comm
2. seweiw eMyeegud 7 oooO o O FFereveniediromstaring oy one phase interrupted multi phase Not multi phase 4 2 Capacitors No motor capacitor NISI S MAINS transformers Approved power unit Attach drawing of MAINS transformers showing all protective devices 4 4 2 8 Outputs v 4 4 2 9 Equipment for more than one supply v Cooling oingle supply see Form A 2 air holes closed No filters fans stopped see Form A 2 coolant stopped No coolant loss of cooling liquid No cooling liquid Heating devices No heating device timer overridden temperature controller overridden 4 4 2 12 Insulation between circuits and parts Approved power unit 4 4 2 13 Interlocks No interlock 4 4 2 14 Voltage selectors i No voltage selectors List below all SINGLE FAULT CONDITIONS not covered by 4 4 2 2 to 4 4 2 14 Supplementary information see Form A 2 for details of tests E Ul SEE ES BUR X X n lt 1303269 762 Page 41 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark TABLE Testing in SINGLE FAULT CONDITION Results Test Fault Fault description Td 4 4 3 How was test terminated Meets subclause No NOTE Comments 4 4 4 4 4 2 1 1 Wrong setting on functional knob 30min No hazards occurred and no accessible conductive parts have become hazardous live 4 4 2 3 Open Protective conduc
3. d No failure of cord insulation in anchorage with metal parts Plug pins which receive a charge from an internal see Form A 7 capacitor 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 36 N A O gt O e Q3 b Input has a protective earth conductor if outlet has EARTH TERMINAL CONTACT Disconnection from supply source By means of appliance inlet O Disconnects all current carrying conductors MEM Exceptions The disconnecting means will disconnect all current carrying conductors Requirements according to type of equipment PERMANENTLY CONNECTED EQUIPMENT and multi phase Non permanently connected equipment Employs switch or circuit breaker O NO O gt CO O L CO L N A N A lt T1303269 762 gt Page 25 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 If switch or circuit breaker is not part of the equipment documentation requires a Switch or circuit breaker to be included in building installation Suitable location easily reached Marking as disconnecting for the equipment 6 11 3 2 Single phase cord connected equipment Es b C Equipment is provided with one of the following a Switch or circuit breaker b Appliance coupler disconnectable without tool By means of ap
4. Equipment subjected to suitable stresses of 8 2 and 8 3 No dielectric breakdown complying with criteria of 8 1 10 5 3 Insulating material BEEN a Parts supporting parts connected to MAINS supply The insulation which supports the terminals did not soften to an extent that could cause a hazard of further short circuits b TERMINALS carrying a current more than 0 5 A umm Examination of material data or MR DN 24 24 PROTECTION AGAINST HAZARDS FROM FLUIDS Protection to OPERATORS and surrounding area provided by EQUIPMENT All fluids specified by manufacturer considered Spillage see Form A 24 If in NORMAL USE liquid is likely to be spilled into the equipment the equipment shall be designed so that no HAZARD will occur as a result of the wetting of insulation or of internal uninsulated parts which are HAZARDOUS LIVE or as a result of the contact of potentially aggressive substances such as corrosive toxic or flammable liquids with parts of the equipment IEC 61010 2 101 Battery electrolyte No battery NA ld 35 LF _F Ee Fd P p P i 11 1 m NI ELA Fe N A lt T1303269 762 gt Page 34 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Battery electrolyte leakage presents no HAZARD 11 6 Specially protected equipment see Form A 24 No IP rating n2 Maximum pressure eeeeeeeennnnen see Form A 25 __ Maximum pressure
5. IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Non metallic materials have flammability Complied with V 1 for the classification V 1 or better adapters 3 ENCLOSURE and any baffle or flame barrier have The enclosure have adequate rigidity adequate rigidity Limited energy circuit see Form A 19 N A Not evaluated to limited energy a Potential not more than 30 r m s and 42 4 V peak N or 60 V dc b Current limited by one of following means MEER N 1 Inherently or by impedance see Table 17 or 2 Over current protective device see Table 18 Or 3 Aregulating network limits also in SINGLE FAULT CONDITION see Table 17 C Is separated by at least BASIC INSULATION a Fuse or a nonadjustable electromechanical device is used Requirements for equipment containing or using No flammable liquid is flammable liquids provided Flammable liquids contained in or specified for use see Form A 20 N with equipment do not cause spread of fire N N N N N N RISK is reduced to a tolerable level N N N N N N N O1 a The temperature of surface or parts in contact with flammable liquids is 25 C below fire point b The quantity of liquid is limited n c Flames are contained within the equipment CT Detailed instructions for RISK reduction provided T T EN Overcurrent protection co 6 1 MAINS supplied equipment protected In the power supply BASIC INSUL
6. a thickness at least applicable distance of Table 8 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 1 or rT T NA lt T1303269 762 gt Page 23 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict N A d c test of 6 8 3 2 for circuits stressed only by d c voltages Procedure for dielectric strength tests see Form A 5 and A 14 Constructional requirements for protection against electric shock 6 9 1 If a failure could cause a HAZARD a Security of wiring connections Screws securing removable covers oO Accidental loosening CREEPAGE and CLEARANCES not reduced below the values of basic insulation by loosening 9 2 Material not to be used for safety relevant insulation Easily damaged materials not used No such material is used Non impregnated hydroscopic materials not used Same as above 9 3 Colour coding Green and yellow insulation shall not be used except G Y wires are only used for earthing or bonding protective earth conductors protective bonding conductors potential equalization conductors No such terminal N A RIA d functional earth conductors O 10 Connection to MA
7. 2035 4063 70 00 2837 aP s esme 1087 4270 5327 730 1973 aP s ese 1057 3342 ss 6000 m60 AVG L3 72100 1s 460 sees 73 00 16 95 aP e 72100 1059 36 26 sss 6000 19 15 AVG Ls 75300 1061 79 5240 7300 2060 _aP_ u s2220 1065 sess 5020 730 2280 aP Tis 929 1070 s a71 7300 2589 aP AVG Note Level Reading Factor Margin Level Limit Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 14 0f50 CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase NEUTRAL _ Dectection Box Temperature Box l TeSEIQuUods Working Main Temperature Box Temperature l i 52 Test Date Sep 30 2013 Humidity l ressure 100 0 dBu m Class A Conduction QP Class A Conduction AVG 50 i x 0 150 MHz 5 30 000 0 5 Frequency Factor Reading Level Limit Margin Detector P F MHz dB dBuV dBuV dBuV dB etector L3 919 10 37 37 07 araa 79 00 orso oP Ea L3 ozs 1034 orso rs 7900 forio GP s some 1055 3553 aeos 7300 260q aP 72 9 ws 572 5620 750 ier oP Lu 75300 1o60 arao 5200 7500 21 00 oP 1s 8 0300 1062 sess s047 73 00 zzss oP Note Level Reading Factor Margin Level Limit esso 10 55 4250 sos 7300 ess aP
8. 7 3 9 Description of Test Syste Massironi einet ena cu E edax aeu sh ex eee RA Na Push esa dus bnt i Ea pn 8 3 4 General Information of Test essseeesssssessssssssssseseeese nennen nnne nnnai nnn seni nnns snas rss nain essais 9 3 5 Measurement Uncertainty cccccccccssssscceccsesseceeeceeeeeeeeesseeeceeeceaaseeeeeseeaeeeessseaecesessaaeeeeessaaageeess 9 4 Test of Conducted EMISSION iicsiscccceccicincdctsctacec e ooi paa aOoEE daas e reU Des va CHR S eeu wU EUR Dro RE eaa EeE NE DANCE v VA cEViDS D PE TUNE RE RPEE 10 BM WS EAI t 10 42 dest ad 801 6 0 o gt Bem een eite onte ce dada ee Si ene ARD dU EE dE 10 A43 Typical test se UD PRETEND E 11 4 4 Measurement Equipment ccccccecccccseseccceeeceecneeeeeeseuseeeseeeceeseaeeeeseaeeessegeeeesseeeessaneeessaneeesseags 11 45 PESTS SUM ING Dala 12 46 Test Photographs e 16 5 TESUOr MaGlated EMiS SIOM sicie a a aE ia 17 Sde Tes e E E eee E ee eee M eee 17 2 E ag 06126 B aae a E enone N E 18 993 Typical TeS SetU esne eee ee eee ee 18 5 4 Measurement Equipment cccccssccccssseccccesceccesececeageeecseuseeeseueeessageeesseaseeessseeessageeessagseesseass 18 5 5 lESUMESUIT ANG ER LT 19 S HOSE TOL UNS ave Um 23 M FRAUEN ST SU dc c 24 6 1 Limits of Harmonics Current M
9. Spit Test engineer Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 150f50 m Lo CC a CERPASS TECHNOLOGY CORP Report No TEEX1303269 4 6 Test Photographs Front View Rear View Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 16 of 50 C CERPASS TECHNOLOGY CORP Report No TEEX1303269 5 Test of Radiated Emission 5 1 Test Limit The EUT and its simulators are placed on a turn table which is 0 8 meter above ground The turn table can rotate 360 degrees to determine the position of the maximum emission level The EUT was positioned such that the distance from antenna to the EUT was 10 meters The antenna can move up and down between 1 meter and 4 meters to find out the maximum emission level Both horizontal and vertical polarization of the antenna are set on measurement In order to find the maximum emission all of the interface cables must be manipulated on radiated measurement Radiated emissions were invested over the frequency range from 30MHz to1GHz using a receiver bandwidth of 120kHz Radiated was performed at an antenna to EUT distance of 10 meters Limits for radiated disturbances at a measuring distance of 10m Frequency range Class A Equipment Class B Equipment MHz Quasi Peak dB uV m Quasi Peak dB uV m 30 230 230 1000 Remark 1 The tighter limit shal
10. lt I 1303269 762 gt Page 4 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Required markings are not put on parts which can be removed by an OPERATOR IEC 61010 2 101 Letter symbols IEC 60027 used IEC 61010 2101 Graphic symbols table 1 used IEC 61010 2 101 Comply with Table 1 Verdict 5 1 2 Identification IEC 61010 2 101 Equipment shall as a minimum be marked with the following information IEC 61010 2 101 a manufacturer s name or trade mark and the address The address shall include at least the city and country b model number name or other means of identifying See page 1 the equipment C where this is required by regulation the name and address of the authorized representative of the manufacturer IEC 61010 2 101 Mag u The following additional information shall be marked on the equipment or packaging or in the instructions for use IEC 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 IEC 61010 2 101 2 the following information IEC 61010 2 101 i a clear indication that the equipment is IVD medical Marked on the label LOT No is marked equipment IEC 61010 2 101 li if applicable a clear indication that the equipment is Not a self test IVD N A self test IVD medical equipment IEC 61010 2 101 iii if a potenti
11. IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict 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 over 300V voltage of 1 5 times working voltage for BASIC or SUPPLEMENTARY INSULATION value for REINFORCED INSULATION are twice the Same as above N A WORKING VOLTAGE 6 3 4 2 N A 3 inner layers of printed wiring boards requirements of 6 7 3 4 3 4 thin film insulation requirements of 6 7 3 4 4 7 3 4 Moulded and potted parts Conductors between same two layers are separated by applicable distances of Table 8 N N A N A ss 7 3 4 Inner insulation layers of printed wiring boards 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 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 N A REINFORCED INSULATION have adequate electric strength one of following methods used O O N N CO CO A A CO NO
12. M22 ralean O OOOO oo WA Po Battery load and charging circuit diagram ee eee F Battery type ccc qoo pb EMEN Battery manufacturer model catalogue No ENTRE Battery ratings sl a E ee NNMNMg2gs2 Supplementary information No battery is used 144 TABLE components ooo Po object part No manufac type model technical data mark s of turer trademark conformity Interchangeable Interchangeable 105 C min V 1 min Inlet with fuse holder 083 01001 00 250V 10A Fuse 2 provided Interchangeable Interchangeable 250V F6 3A Semko Power Switch Everel 82 XX 8 250V 16A 4P ENEC eum oo nn mmt Power supply unit Mean Well NES 75 12 I P 100 240V 50 60Hz 1 5A TUV Fan ECTOISLIZCA 2Vdc 0 14A 1 68W u Fan O E UL lt T1303269 762 Page 61 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 143 TABLE Overtemperature protection devices Form A 29 Reliability test Component Type Verdict Comments NOTE NSR non self resetting 10 times NR non resetting 1 time SR self resetting 200 times Supplementary information lt T1303269 762 gt Page 62 of 66 O IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict 148 TABLE Transient overvoltage limiting devices Form A 30 NA LN CC Overvoltage MAINS voltage Test ae tnax Rupture Circuit breaker Verdict Comments E Test room ambient temperature NOTE
13. Xindian District New Taipei City 231 Taiwan 28 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Appendix D Warning Icon Description 4 1 This Way Up a THIS WAY UP Careful Fragile FRAGILE Keep Dry Away From Magnetic Field Away from the field MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 2 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 NS make life healty y MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 30 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Chapter 9 Manufacturing 9 Manufacturing The manufacturing details of Magnetic Immunoassay Analyzer XacPro E are illustrated in MagQu s Quaility Management System 1 e ISO13485 2003 9 1 Manufacturing Process Following are steps to manufacture XacPro E e Manufacturing coils Round copper wire to the coils then put the coils into the shell Manufacturing Electronics Build function generating system temperature control system filter and amplifier system and data acquiring system and put them into the shell e QC and packaging The background value should be less than 15 and the signal of the sample should be 30 to 60 After QC pass and labeling surround the device by cushion material and c
14. but are not MAINS circuits and have one TERMINAL contact at earth potential No ACCESSIBLE conductive parts are HAZARDOUS LIVE E emwdensndomanems A Vewedoshed 0 07 ACCESSIBLE conductive parts DAGLI NN NN E Insulation requirements 6 7 1 The nature of insulation E O N lt T1303269 762 gt Page 19 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Insulation between ACCESSIBLE parts or between Complied with insulation separate circuits consist of CLEARANCES CREEPAGE requirement DISTANCES and solid insulation if provided as protection against a HAZARD CLEARANCES Required CLEARANCES reflecting factors of 6 7 1 1 Equipment rated for operating altitude greater than Not over 2000m N A 2000 m correction factor of Table 3 of 61010 1 applied Required CLEARANCES reflecting factors of 6 7 1 1 see Form A 5 see Form A 5 Ges Fom AS CAT II and not over 300V to nominal supply voltage of 300 V b 6 7 3 Secondary circuits separated from circuits oame as above defined in a by transformer C K 1 MAINS circuits of OVERVOLTAGE CATEGORY III and CAT IIl and not over 300V N A IV or OVERVOLTAGE CATEGORY II over 300 V d K 2 Secondary circuits separated from circuits N A defined in c by transformer N A e K 3 Circuits having one or more of Insulation in circuits not addressed in 6 7 K 1 or K 2 and in measuring circuits where MEASUREMENT CATEGORIE
15. could be emitted instructions and requirements for protective devices such as protective glasses IEC 61010 2 101 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 IEC 61010 2 101 lt T1303269 762 gt Page 11 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Not a self test IVD N A Further requirements on instructions for use see EN 591 for IVD medical equipment for professional use EN 592 for self test IVD medical equipment IEC 61010 2 101 5 4 4 101 Self test IVD medical equipment IEC 61010 2 101 Void 4 Equipment maintenance Instructions for RESPONSIBLE BODY include Instructions sufficient in detail permitting safe maintenance and inspection and continued safety cord with inadequate rating Instructions include following subjects permitting safe servicing and continued safety The user s manual provided with the relevant statements a b protective measures for these RISKS C verification of the safe state after repair Integration into systems or effects resulting from special conditions Aspects described in documentation Removal of equipment from use for repair or disposal IEC 61010 2 101 product specific RISKS may affect service personnel O1 D O1 5 4 6 Instructions shall be provided for the
16. gl M LabviEW Run Twrw Engine 7 1 Setup Welcome to the NI LabVIEW Run Time Engine 7 1 Installation Wizard Mofa tacconnonded tha pou ex ali wmdows progtalne bet ore runeiro thee Uk Cancel bo qual the setup magan then chore any progiams yeah eve niring Dick Nes to continue de rotting WISFRIMING The progres io prokectesd by oops ghi law ond invention eie Von oes Mondelo 10r dokon of this program or en portion ol iL may ME andi cimi penales sd vll be proseou ed to the maium sib denies voces har AC ho 14 Lir 130 MieCyuan DE onda Darit Nex Tapii City Tan Tei 556 2 86871293 Fan 805 2 EeE 1805 UL ewe siageu Com Ema itoduagqu cam 2 Labview driver is provided by National Instruments named Labview run time Engine Users must follow the terms of use from NI and click next XacPro E BY Nr LabVIEW Run Time Engine 7 1 Setup Licunae Agreement You minl agree vll the licence age ene ni be to proce ed OE IRUM RS NATIONAL INSTRUMENTS SOFTWARE LICENSE AGREEMENT INSTALLATION NOTICE THIS 1S A CONTRACT BEFORE YOU DOWNLOAD THE SOFTWARE ANDIOR COMPLETE THE INSTALLATION PROCESS ins CAREFULLY READ THIS AGREEMENT BY DOWNLOADING THE J SOFTWARE ANDOR CLICKING THE APPLICABLE BUTTON TO COMPLETE THE INSTALLATION PROCESS YOU CONSENT TO THE TERMS OF THIS a M AGREEMENT AND YOU AGREE TO BE BOUND BY THS AGREEMENT IF i YOU DO NOT WISH TO BECONE A PARTY TO THIS AGREEMENT AND BE D accept the kreme agn emet do not sc
17. j lesting shall be performed according to a Test Plan which shall be included in the test report k It may be necessary to carry out some investigatory testing in order to establish some aspects of the test plan 12 2 Test Severity Levels Voltage Level e m f 1V 3 V 10 V Specified NOTE x is an open class This level can be specified in the product specification 12 3 Measurement Equipment Instrument Model No Calibration Date Valid Date CS GENERATOR NSG 2070 1059 2013 09 11 2014 09 10 CDN M2 M3 Schaffner M016 20056 2013 09 14 2014 09 13 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 420f 50 o CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 12 4 Test Result and Data Final Test Result PASS Pass performance criteria A Required performance criteria A Basic Standard IEC 61000 4 6 Product Standard EN 61326 1 Coupling mode CDN M3 for AC power ports Temperature 25 C Relative Humidity 58 Atmospheric Pressure 1011 hPa Test Date Oct 13 2013 Frequency 0 15 80MHz Modulation AM 80 1KHz sine wave Dwell time 3s Frequency Step Size 1 96 of preceding frequency value Note A normal performance within levels E by the manufacturer requestor or purchaser Test engineer E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013
18. of 6 7 2 2 3 1 a b i 7 2 2 i iri i N A d thin film insulation requirements of 6 7 2 2 4 EEE at least 0 4 mm after moulding is completed N A REINFORCED INSULATION have adequate electric strength one of following methods used i a thickness at least 0 4 mm b insulation is assembled of minimum two separate N A layers each RATED for test voltage of Table 5 for BASIC INSULATION insulation is assembled of minimum two separate N A layers where the combination is rated for test voltage of Table 5 for REINFORCED INSULATION N A 6 7 2 2 4 Thin film insulation No such parts Conductors between same 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 N A N A a thickness at least 0 4 mm b insulation is assembled of min two separate layers each RATED for test voltage of Table 5 for BASIC INSULATION lt T1303269 762 gt Page 21 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict 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 OVERVOLTAGE CATEGORY Il up to 300 V 6 7 3 1 Secondary circuits where separation from MAINS CI
19. 1F Test Report Form s Originator Cerpass Test item description Trademark Model and or type reference Rating s 100 240Vac 50 60Hz 1 5 0 8A Class Manufacturer Same as Applicant lt T1303269 762 Page 2 of 66 OQ Test item particulars Type of item REED Measurement Contrel Laboratory Connection to MAINS supply sssssesse Permanent Detachable cord set Nord habl N Di TEE Installation category sssesessssssssssss Il POLLUTION DEGREE ceesseeeeeeee nennen nnns 2 Protection class cccccecceccececceccececceccecauceceueaeeeeaueecaees Class Environmental rating seseeeeeeeeeeeeeeee Standard Extended Specify Equipment mobility sseeeeeeeeeeeeeeee Portable Hand held Floorstanding Fixed BHn Operating conditions cccccceecessseeeeeeesssssseeeeeeeeeens Continuous Sher time Hntermittent 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 General remarks The test results presented in this report relate only to the object tested This report shall not be reproduced exc
20. 22 6 V peak or 35 V d c Voltages are not HAZARDOUS LIVE the levels of CO b Current less than 0 5 mA r m s for sinusoidal 0 7 The accessible voltage mA peak non sinusoidal or mixed frequencies or 2 levels not exceed 33V r m s A A N 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 C Levels of capacitive charge or energy less 1 45 uC for voltages up to 15 kV peak or d c or line A of Figure 3 2 350 mJ stored energy for voltages above 15 kV peak or d c 6 3 2 Levels in SINGLE FAULT CONDITION see Form A 7 for wet locations measuring circuit A 4 used or N A N A N A N A 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 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 and 22 6 V peak or 35 V d c Voltages are not HAZARDOUS LIVE the levels of Oe b Current less than 0 5 mA r m s for sinusoidal 0 7 The accessible voltage mA peak non sinusoidal or mixed frequencies or 2 levels not exceed 33V A A N mA d c when measured with measuring circuit A 1 r m s and 46 7V peak or or A 2 if less than 100 Hz 70V d c C Levels of capacitive charge or energy less 45 uC for voltages up to 15 kV peak or d c or line A of Figure 3 for wet locations measuring circuit A 4 used or N A N A N A N A 1 2 3
21. 61010 1 IEC EN 61010 2 101 TABLE Constructional requirements Form A 18 N A 14 7 Printed circuit boards Material tested I HB m ECHTE po Be RAMANA acit rena meri poo Colour id Se Conditioning details ccc po D S S S S S LI Sapte Sampe2 Samples Thickness of specimen mm fF Duration of flaming after first Application fs J o Mewewme After second application Specimen burns to holding camp YesNo ooo o o coronigntes T S A Supplementary information Printed circuit boards of material with a flammability classification of FV 0 min of IEC60707 or UL94 is used lt 11303269 762 gt Page 54 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Form A 19 N A 9 4 TABLE Limited energy circuit Maximum m in Maximum Maximum Overload Circuit TA circuit voltage available available protection separation Yes No Comments m s d c current after 120 s Supplementary information Not evaluated Form A 20 N A 95 TABLE Requirements for equipment containing or using flammable liquids Type of liquid 9 5 Flammable liquids Supplementary information No flammable liquid lt T1303269 762 Page 55 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark TABLE Temperature Measurements Form A 21A Surface temperature limits NORMAL CONDITION and or SINGLE FAULT CONDITION 10 2 Tempe
22. 886 2 86671809 Section II Function generating circuit F1 amp F2 1 Circuit Diagram The digital AC waves to drive coils are generated by Function generating circuit Fl and F2 The AC waves typically involve two frequencies one is at hundreds of hertz and the other is at dozens of kilohertz The AC waves of two frequencies are connected with coils through digital analog converter D A shown in Fig 3 Fig 3 Circuit diagram of digital analog converter for AC waves 2 Function The AC wave generator is used to supply AC voltages at multiple frequencies to generate AC currents flowing through the coils The coils then generate AC magnetic fields Section HI Coils 1 Structure Diagram Structure of coils is shown as Fig 4 including three different coaxial solenoids shown on the right of Fig 4 and made of plastic steel and wound with copper wires Solenoid tube 35 Support Support Support for for for pick up coil excitation excitation coil coil Fig 4 Scheme of coils MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 9 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 2 Function After the AC signals generated by DSP mentioned above pass through copper wires of two excitation coils respectively Each coil generates an AC magnetic field to magnetize magnetic reagent located inside the pick up coil
23. CONDITION or in SINGLE FAULT CONDITION IEC 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 quantities likely to be hazardous The areas of the equipment containing such substances shall be equipped with protective covers or similar means of protection IEC 61010 2 101 13 2 Explosion and implosion Components not likely to N A explode in overheated N A Components liable to explode Pressure release device provided or N A Apparatus incorporates operator N A protection see also 7 7 N A N A N A N lt A In case of wrong type of battery used Warning by marking and within instructions lt A N A lt T1303269 762 gt Page 37 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Equipment with means to charge rechargeable batteries Warning against the charging of non rechargeable batteries and Type of rechargeable battery indicated or f Symbol t4used o G Battery compartment design Single component failure Polarity reversaltest Implosion of cathode ray tubes No cathode ray tubes is used If maximum face dimensions gt 160 mm a Invinsealy protected andcoreatymouned on mecwwpwmespweo Wewiwwekdypoecet Seeennotremoveblewitwuttoot ooo lass screen notn conaatwin sweets COMPONENTS AND SUBASSEMBLIES MEE Where safety is involved compo
24. Can Be Used to Identify Medical Device Characteristics That 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 C 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 1n contact with the medical device Ans Magnetic fluid reagent and test samples C 2 5 Is energy delivered to and or gt extracted from the patient Ans No C 2 6 Are substances delivered to and or extracted from the patient Ans No C 2 7 Are biological materials processed by medical device for subsequent re use transfusion or transplantation Ans No C 2 8 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 u
25. EN 61326 1 2013 EN 61000 3 2 2006 A1 2009 A2 2009 EN 61326 2 1 2013 EN 61000 3 3 2008 IEC 61000 4 2 2008 IEC 61000 4 3 2006 A1 2007 A2 2010 IEC 61000 4 4 2012 IEC 61000 4 5 2005 IEC 61000 4 6 2008 IEC 61000 4 8 2009 IEC 61000 4 11 2004 Applicant MagQu Co Ltd _ 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist n New Taipei City 231 Taiwan Equipment Magnetic Immunoassay Analyzer Model No XacPro E301 Trade Name MagQu The test result refers exclusively to the test presented test model sample Without written approval of Cerpass Technology Corp the test report shall not be reproduced except in full This test report is only applicable to European Community ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 1 of 50 uU CERPASS TECHNOLOGY CORP Report No TEEX1303269 Contents 1 Summary of Test Procedure and Test Results 111 leeeee eei eeeeee eee iieee eene nnne nnmnnn nnn n nnn 6 2 Immunity Testing Performance Criteria Definition eeeee i eeeeee eee reeeee eese nenne nennen 6 3 Test Configuration of Equipment under Test e e llieeee eee iieeee eee e eene n enn nhan nnn anna nana nnns 7 3 1 Feature of Equipment under TeSt cccccccsssseccecceeeeceeeceeeseceeeseeeseceeeseeaseeeeesssaeeeeessaaaeeeeessaaaaeees 7 Io LIC RN Ec mom
26. Humidity 58 Atmospheric Pressure 1011 hPa Test Date Oct 03 2013 Pulse 5 50 ns Repetition Rate 5 kHz Burst 15m 300ms Test time 1 min each condition Voltage Mode Polarity _0 5 kV 1 0 kV _2 0 kV Result Phase 4 L A A A A A A N A A A A A A L N A A A A A A Power Line PE A A A A A A L PE A A A A A A N PE A A A A A A L N PE A A A A A A Note A normal performance within levels specified by the manufacturer requestor or purchaser Test engineer oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 37 of 50 a CERPASS TECHNOLOGY CORP Report No TEEX1303269 C 10 5 Test Photographs E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 38 of 50 CE e __CERPASS TECHNOLOGY CORP Epon OL EEUU 11 Surge Immunity Test 11 1 Test Procedure a Climatic conditions The climatic conditions shall comply with the following requirements e ambient temperature 15 C to 35 C e relative humidity 10 96 to 75 96 e atmospheric pressure 86 kPa to 106 kPa 860 mbar to 1060 mbar b Electromagnetic conditions the electromagnetic environment of the laboratory shall not influence the test results c The test shall be performed according the test plan that shall specify the test set up with gener
27. Identifies HAZARDS and estimates RISK b RIsk evaluation Plan to judge acceptability of resulting RISK level based on the estimated severity and likelinood of a RISK c RISK reduction Initial RISK reduced by counter measures Repeated RISK evaluation without new RISKS introduced HISKS remaining after RISK assessment addressed in instructions to RESPONSIBLE BODY Information contained how to mitigate these RISKS Following principles in methods of RISK reduction applied by manufacturer in given order 1 Risks eliminated or reduced as far as possible 2 Protective measures taken for RISKS that cannot be eliminated 3 User information about residual RISK due to any defect of the protective measures Indication of particular training is required Specification of the need for personal protective equipment Conformity checked by evaluation of the RISK assessment documentation lt T1303269 762 Page 40 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark IEC 61010 1 EN61010 2 101 Requirement Test Result Remark Verdict TABLE Summary of SINGLE FAULT CONDITIONS Form A 1 OP Subclause Title Does not Carried Comments apply out 4 4 2 1 SINGLE FAULT CONDITIONS not covered by di see Form A 2 4 4 2 2 to 4 4 2 14 4422 _ Provecrwenmeomce 7 Neptecheimpedame saza _ Protecrweconoucron ieee Forma e mmuureme 0 met intermittent operation azs wes eme
28. Module Configuration bosed Data Logger 30 days trial f US8 1901 1902 1903 TE DAGBench ActiveX Controls for Test amp Measurement Software Package Driver Installation LASA ADLINK on web Manual E Readme E Comactus D ext Measurements ADLINKUSB DAQ A Version MOTY AT TEL DAGPilo k ask onented DA DAQMaster System manager for ADLINK DAG Cards U Test USB DAG Testing Application Software Package Diver isiataion C ADLINK on Web Manual B Recs ne E Contact Us 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 14 8 DAQ Pilot is provided by ADLink Technology Users must follow the terms of use of ADLink Techonology Then click Next KE i3 ADLINK DAQPilot V2 3 1 1201 InstallShield Wizard Welcome to the InstallShield Wizard for ADLINK DAQPilot V2 3 1 1201 The InstallShield R Wizard will allow you to modify repair or remove ADLINK DAQPilot V2 3 1 1201 To continue dick Next 9 Follow the installing guild and click Next and Install r i ADLINK DAQPilot V2 3 1 1201 InstallShield Wizard Custom Setup Select the program features you want installed Click on an icon in the list below to change how a feature is installed Feature Description SDK Samples Manual DAQPilot Runtime This feature requires OKB
29. System Cert No TW 14 10079 _ Product Master file No MF02 Product user Manual XacPro E ver 201309 Comments Clause Description Appli cable or not 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 their performance is maintained in accordance with the intended use Standard Sub clause s Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 Report Document Comments ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 Product user Manual XacPro E ver 201309 Clause 7 4 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 i
30. TEEXI303260 S S 5 6 Test Photographs Front View Hear View ST SN CRIT aT TNR T ai jo E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 23 of 50 CE e CERPASS TECHNOLOGY CORP Epon OL EEUU 6 Harmonics Test 6 1 Limits of Harmonics Current Measurement Limits for Class A equipment Limits for Class D equipment Harmonics Max Permissible Harmonics Max Permissible Max Permissible Order harmonics Order harmonics current per harmonics current n current n watt mA W A A 5 9 05 040 9 04 re rr MMZMJMWUWJ LLL LLL LLL 6 owo Oe Jw LJ o o LLL NOTE 1 ClassA and Class D are classified according to item section 5 of EN 61000 3 2 2006 A1 2009 A2 2009 2 According go section 7 of EN 61000 3 2 2006 A1 2009 A2 2009 the above limits for all equipment except for lighting equipment are for all applications having a rated power gt 75 W and no limits apply for equipment with an active input power up to and including 75 W 6 2 Test Result and Data The limits are not specified for equipment with a rated power of 75W or less The EUT meets the above condition so it conforms to EN 61000 3 2 ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 240f50 C CERPASS TECHNOLOGY CORP
31. Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 43 of 50 m iO Cc sa CERPASS TECHNOLOGY CORP Report No TEEX1303269 12 5 Test Photographs ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 44 of 50 c CERPASS TECHNOLOGY CORP Report No TEEX1303269 13 Power Frequency Magnetic Field Immunity Test 13 1 Test Setup GPR Ground plane C1 i Power supply circuit A Safety earth C2 Signal circuit S Insulating support L Communication line EUT Equipment under test B To power supply source Lc Induction coil D To signal source simulator E Earth terminal G To the test generator 13 2 Test Severity Levels Magnetic field strength A m CO L amp C special NOTE 1 X is an open level This level can be given in the product specification 13 3 Measurement Equipment Manufacturer Model No Serial No Calibration Date Valid Date MAGNETIC FIELD F 1000 4 8 G GENERATOR KeyTek AeA 2013 09 12 2014 09 11 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 45 of 50 o CE C CERPASS TECHNOLOGY CORP Report No TEEX1303269 13 4 Test Result and Data Final Test Result PASS Pass performance criteria A Required performance criteria A Basic Standard IEC 61000 4 8 Product Standard EN 61326 1 Temperature 25 C Relative Humi
32. _ product information complaining customer information and complaint information 5 6 2 The QA manager will verifv the complaint details and will perform a comprehensive investigation to determine the direct and or indirect causes for the failure In addition all variables that might affect process capability to comply with the requirements should be identified 5 6 3 5 6 4 5 6 5 As applicable the Operations department and or other individuals shall participate in the investigation The QA manager shall inform the Senior VP Operations and the QA RA Director in case that an investigation is required As applicable based on the information received the QA manager will locate all the information related to the device involved in the complaint from the incoming inspection of raw materials until its marketing including test results manufacturing records etc A copy of all relevant documents will be attached to the complaint file All complaint files shall be reviewed to gather additional relevant information Complaint reports shall be reviewed in order to verify that there is no significant problem recurring periodically 5 7 Interaction with the customer 5 7 1 5 7 2 5 7 3 5 7 4 A confirmation shall be delivered to the client within one week from receiving the complaint as applicable it will be clarified that final response shall be delivered following completion of the investigation and conclusion
33. be conducted and pass criteria of 8 1 Supplementary information 10 5 3 TABLE Insulating Materials Form A 23 10 5 3 1 Ball pressure test BEEN Max allowed impression diameter l Test temperature Impression Diameter C mm Supplementary information 10 5 32 Vicat softening test ISO 306 NA Vicat softening temperature Thickness of sample C mm Supplementary information lt T1303269 762 gt Page 57 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict TABLE Mechanical resistance to shock and impact Form A 24 Protection against HAZARDS from fluids Voltage tests can be carried out once after performing the tests of clause 8 and clause 11 However if voltage tests are carried out separately after each set of tests two forms can be used Location i Impact Normal Handheld Cleaning Spillage Overflow Working Test Verdict Comments see form A 5 2 8 2 2 8 3 1 voltage voltage V TOP i Pass Pass Pass 240V 3480V Plastic parts Enclosure Side l Pass Pass Pass 240V 3480V Plastic parts Enclosure Rear Pass Pass Pass Pass 240V 3480V Plastic parts Enclosure Front Pass Pass Pass 240V 3480V Plastic parts Enclosure NOTE Use r m s d c or peak to indicate the used test voltage Supplementary information lt T1303269 762 Page 58 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requireme
34. 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 3 drop test of 8 3 1 or 8 3 2 except for FIXED and EQUIPMENT with mass over 100 kg Equipment rated with an impact rating of IK 08 that Not so rated N A obviously meets the criteria 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 li ENCLOSURE shows no cracks resulting in a HAZARD No cracks which could cause a hazard N A N A iii CLEARANCES not less than their permitted values No less than their permitted values and the insulation of internal wiring remain undamaged lt T1303269 762 gt Page 29 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark 30 N with 12 mm rod to each part of ENCLOSURE in case of doubt test conducted at maximum RATED ambient temperature Static test Impact test P J Impact applied to any part of ENCLOSURE causing a HAZARD if damaged Impact energy level and corresponding IK code No IK coded Non metallic ENCLOSURES cooled to minimum RATED ambient temperature if below 2 C Drop test EA Other than HAND HELD and DIRECT PLUG IN EQUIPMENT Portable equipment Tests conducted with a d
35. customers and or users sent out by a manufacturer or its representative in relation to a field safety corrective action Procedure 5 1 3 2 S49 5 4 245 5 6 A customer complaint can be reported at any stage in the product life cycle from the moment the product left the company by the agent distributor and or by the customer doctor medical center etc The receiver of the complaint shall ask the complainant or his representative to give the most thorough details about the complaint additional documents that attest it examinations of the patient etc At the time of receiving the complaint no assumptions or solutions will be given regarding the complaint the reason for the problem or the conclusions The purpose of the communications at this stage is only to obtain the maximum amount of information In case a physician s complaint is received indirectly for example through a distributor or a salesman the complaint receiver shall inquire about the physician s contact details and about other persons who were present when the problem was discovered The receiver of the complaint shall document the complaint details and forward it to the QA manager Review of the complaint 5 6 1 Once the complaint is received at the company the following actions shall be taken 5 6 1 1 The complaint will be given an identification number for follow up 5 6 1 2 A Customer complaint form will be filled out including
36. device and the event but not later than 10 calendar days following the date of awareness of the event Others immediately after establishing a link between the device and the event but not later than 30 calendar days following the date of awareness of the event If after becoming aware of a potentially reportable incident there is still uncertainty about whether the event is reportable a report must submitted within the timeframe required for that type of incident 5 16 If it appears that a complaint might be related to other marketed devices and safety hazard exist the CEO QA RA Director and QA manager shall consider initiating an FSCA and or sending field safety notice to the 8 customers 5 17 Field Safety Corrective Action FSCA 5 17 1 5 17 2 5 17 3 5 17 4 5 17 5 The national competent authority must be reported on any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer Those reasons includes 5 17 1 1 Any malfunction or deterioration in the characteristics and or performance of a device 5 17 1 2 Any inadequacy in the instructions for use which might lead to the death of a patient or user or to a serious deterioration in his state of health Removals from the market for purely commercial non safety related reasons are not included The company shall issue a notification to the competent authorities of all countries affected at the sam
37. fuse marking see also 5 4 5 cess sssssuse 5 1 5 TERMINALS connections and operating devices MEN Where necessary for safety indication of purpose of Purpose is marked TERMINALS connectors controls and indicators marked Adequately marked If insufficient space symbol 14 used Push buttons and actuators of emergency stop devices No emergency stop and indicators a Massen imsaindiili D wemenwragison 0 mem 0 wwiessedeinEGRE p S Supplementary means of coding provided if meaning of colour relates see IEC 60073 to safety of persons or safety of the environment C1 C N A N A N A N A N A N A N A lt 11303269 762 gt Page 6 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Hesult Remark Verdict i D c o D Requirement Test MAINS supply TERMINAL identified Other TERMINAL marking WB No functional earth N A a FUNCTIONAL EARTH TERMINALS symbol 5 used b PROTECTIVE CONDUCTOR TERMINALS Appliance inlet is used oymbol 6 Dis placed close to or on the TERMINAL or Part of appliance inlet N 171 N A C TERMINALS of control circuits symbol 7 used No symbol 7 is needed d HAZARDOUS LIVE TERMINALS supplied from the No live terminal supplied N A interior from interior N A Standard MAINS socket outlet or N A Symbol 14 used N A 5 1 6 Switches and circuit breakers If disconnecting device off position clearly marked N
38. not removable without tool 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 table 20 10 3 Other temperature measurements Following measurements conducted if applicable see Form A 21A 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 10 4 10 4 1 Conduct of temperature test Tests conducted under reference test conditions and see Form A 21A manufacturer s instructions lt T1303269 762 gt Page 33 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark 10 4 2 Temperature measurement of heating equipment No heating element is provided l N A LM Tests conducted in test corner see Form A 21A N A 10 4 3 Equipment intended for installation in a cabinet or wall Table top N A N A Equipment built in as specified in installation see Form A 21A instructions Same as above 10 5 Resistance to heat 10 5 2 Non metallic ENCLOSURES see Form A 22 10 5 1 Integrity of CLEARANCE and CREEPAGE DISTANCES see Form A 13 Within 10 min after treatment
39. notify body Where changes are made to an ancillary substance incorporated in a 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 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 Clause Description Appli Standard Sub clause s Report Document Comm
40. of any part does not exceed Pas Fluid containing parts subjected to hydraulic test if see Form A 25 a product of pressure and volume gt 200 kPal and b pressure gt 50 kPa F No refrigeration Jp Parts of refrigerating systems meets pressure related requirements of IEC 60335 24 or IEC 60335 24 11 7 3 Leakage from low pressure parts see Form A 25 11 7 4 Overpressure safety device Does not operate in NORMAL USE Connected as close as possible to parts intended to be protected b Easy access for inspection maintenance and repair DNA RN No shut off valve between overpressure safety device and protected parts A A ULTRASONIC PRESSURE Equipment provides protection 12 PROTECTION AGAINST RADIATION INCLUDING LASER SOURCES AND AGAINST SONIC AND Equipment producing ionizing radiation 12 2 1 lonizing radiation see Form A 26 12 2 1 1 Equipment meets the following requirements Not producing ionizing radiation a ifintended to emit radiation meets requirements of 12 2 1 2 or tested classified and marked in accordance to IEC 60405 lt 11303269 762 gt Page 35 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark b if only emits stray radiation meets requirements of 12 2 1 3 12 2 1 2 No ionizing radiation N A Effective dose rate of radiation measured N A b Abbreviations of the radionuclides l N A N A
41. other non excited RF input ports of the coupling devices are terminated by a 50 ohm load resistor d The frequency range is swept from 150 KHz to 80 MHz using the signal levels established during the setting process and with the disturbance signal 8096 amplitude modulated with a 1KHz sign wave pausing to adjust the RF signal level or to switch coupling devices as necessary The rate of sweep shall no exceed 1 5 x 10 decades s Where the frequency is swept incrementally the step size shall no exceed 1 of the start and thereafter 1 of the preceding frequency value e The dwell time at each frequency shall not be less than the time necessary for the EUT to be exercised and able to respond Sensitive frequencies e g clock frequency ies and harmonics or frequencies of dominant interest shall be analyzed separately f An alternative test procedure may be adopted wherein the frequency range is swept incrementally with a step size not exceeding 4 of the start ad thereafter 4 of the preceding frequency value The test level should be at least twice the value of the specified test level g Incases of dispute the test procedure using a step size not exceeding 1 of the start and thereafter 196 of preceding frequency value shall take precedence h Attempts should be made to fully exercise the EUT during testing and to fully interrogate all exercise modes selected for susceptibility i The use of special exercising programs is recommended
42. procedure has been described The detailed assessment was made according to the requirement and the relevant annexes set out on the standards 1 1 Risk Management Flow Chart The flow chart is shown in Fig 1 1 Flow Verification ISO14971 2007 Intended use Identify characteristics 4 2 Identify known or foreseeable hazards 4 3 Risk analysis Estimate riskis for each hazardous situahon s X4 4 y z 3 Is risk M Mo reduction necessary E 5 en Identify appropnaterisk control measure s record risk control requirements 6 2 No Is the risk reductible 6 2 les Implement record and v enty appropriate measures 6 3 nnnnnmeaainresmesamneasirermenesnereasaines 3 5 i No Is the residual sa risk acceptable E 64 Yes Do medical benefits outweigh the retidual risk 6 4 Are new hazards or hazardeus situations introduced or exiting risks affected 6 6 No No No Are all identified hazards considered 6 7 ae res c is overall residual No Do medical benefits No g E risk acceptable outweigh the overrendual B d 7 5 p clause ha Prepare risk management report clause 8 f v ges N EEEE Es E Review production post production information Unacceptab Sane S clause 9 3 E A amp aS res Is reassessment of risk necessary clause 9 Fig 1 1 Flow chart of risk management for XacPro E 1 2 Question That
43. to be detected XacPro E can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility which is so called immunomagentic reduction 4 1 2 Bill OF Material No Project Quantity Coil 1 Electronics 1 Shell 1 4 1 3 Specification of Materials Used Test Name l Project Exterior Coil Specification Exterior Electronics Specification Exterior Shell Specification Standard No collision damage distortion or other adverse circumstances Excitation coil 1 61 0 5 mm 17 0 5 mm in length Excitation coil 2 0 6140 5 mm 1140 5 mm in length Pick up coil 3040 5 mm 6 0 5 mm in length No collision damage distortion or other adverse circumstances Input voltage 100 240V 60Hz DC Output voltage 0 5V AC Output frequency 100Hz 50KHz Fan works normally No collision damage distortion or other adverse circumstances Temperature Box L 450 W 350H 150 Detection Box L 600W 700H 250 Unit mm Method Visual Actual test Visual Actual test Visual Actual test The details for inspecting the standards of materials used are clearly illustrated in MQ WIQ 03 Quality Management System following ISO 13485 and ISO9001 4 1 4 Software Information The software can be designed by users However the basic software is still available from MagQu Co Ltd Furthermore the version of the software should be al
44. under test according to the following performance criteria Normal performance within the specification limits Temporary degradation or loss of function or performance which is self recoverable e Temporary degradation or loss of function or performance which requires operator intervention or system reset Degradation or loss of function which is not recoverable due to damage of equipment components 10 2 Test Severity Levels The following test severity levels are recommended for the fast transient burst test Open circuit output test voltage 10 On Power Supply On I O signal data and control line 0 5 KV 0 25 KV 1 0 KV 0 50 KV 2 0 KV 1 00 KV 4 0 KV 2 00 KV X opecified Specified Remark X is an open level The level is subject to negotiation between the user and manufacturer or is specified by the manufacturer 10 3 Measurement Equipment Model No Calibration Date Valid Date TESQ NSG3060 TESQ NSG3060 1385 2013 4 11 201 4 4 10 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 36 of 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 10 4 Test Result and Data Final Test Result PASS Pass performance criteria A Required performance criteria B Basic Standard IEC 61000 4 4 Product Standard EN 61326 1 Test Voltage On Power Line 0 5 KV 1 0 KV 2 0 KV Temperature 25 C Relative
45. x Mn UsE DU SERE ER EE E P UE FEUTEDUEME EIFE E nnne A1 A6 ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 3of 50 o Ce CERPASS TECHNOLOGY CORP Report No TEEX1303269 History of this test report BIORIGINAL LI Additional attachment as following record Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 4of 50 o CE C CERPASS TECHNOLOGY CORP Report No TEEX1303269 CERTIFICATE OF COMPLIANCE According to EN 55011 2009 A1 2010 Group 1 Class A EN 61326 1 2013 EN 61000 3 2 2006 A1 2009 A2 2009 EN 61326 2 1 2013 EN 61000 3 3 2008 IEC 61000 4 2 2008 IEC 61000 4 3 2006 A1 2007 A2 2010 IEC 61000 4 4 2012 IEC 61000 4 5 2005 IEC 61000 4 6 2008 IEC 61000 4 8 2009 IEC 61000 4 11 2004 Applicant MagQu Co Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Ur Dist New Taipei City 231 Taiwan Equipment Magnetic Immunoassay Analyzer Model No XacPro E301 HEREBY CERTIFY THAT The measurements shown in this test report were made in accordance with the procedures given in EUROPEAN COUNCIL DIRECTIVE 2004 108 EC The test was carried out on Oct 04 2013 at Cerpass Technology Corp oignature L Hill Chen EMC RF B U Assistant Manager r m AA b VUE Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 5of50 o CE
46. 0 28 2428 4009 1572 ae 400 9 Ls 2100 1267 4230 2063 7 00 ira ae o o e 2546750 1079 sr 26 40 7 00 zoeo ae 00 o Note Level Reading Factor Margin Level Limit il Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 21 0f 50 se CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase HORIZONTAL Test hiode Dectection Box Temperature Box Temperature 06 C Working l 72 Test Date Oct 01 2013 Humidity 07298 ressure 80 0 dBu m Class A 10m Radiation 3 Margin 6 dB 2 40 0 0 300 000 370 00 440 00 510 00 530 00 650 00 720 00 790 00 360 00 1000 00 MHz SIM MHz dB m dBuv dBuV m dBuV m dB j c 422 5000 ee ses 31 90 a700 15 10 ap 100 o F gt 452 6000 588 3436 2848 aroo amp s2 ae 100 o 62 100 298 sosz 2798 a700 e ae 100 9 606 8000 255 siae 2693 a700 e ae 100 9 P Note Level Reading Factor Margin Level Limit 470 9000 53s 4 amp 2 4266 4700 4 4 ap 40 200 VZA Test engineer p E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 220f50 gi fs o p s _ s e gt CERPASS TECHNOLOGY CORP ReportNo
47. 000 MHz 18 000 MHz Vertical Horizontal 5 18 dB ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 9 of 50 CE e CERPASS TECHNOLOGY CORP Epon Mo TEPA UIO 4 Test of Conducted Emission 4 1 Test Limit Conducted Emissions were measured from 150 kHz to 30 MHz with a bandwidth of 9 KHz on the 120 VAC power and return leads of the EUT according to the methods defined in ANSI C63 4 2009 Section 3 1 The EUT was placed on a nonmetallic stand in a shielded room 0 8 meters above the ground plane as shown in section 2 2 The interface cables and equipment positioning were varied within limits of reasonable applications to determine the position produced maximum conducted emissions Conducted Emission Limits L dB M V dB V 015 05 15 0 5 66 6656 56 5646 05 5 0 868 4 amp 6 50 300 60 50 4 2 Test Procedures a The EUT was placed 0 4 meter from the conducting wall of the shielding room was kept at least 80 centimeters from any other grounded conducting surface Connect EUT to the power mains through a line impedance stabilization network LISN All the support units are connecting to the other LISN The LISN provides 50 ohm coupling impedance for the measuring instrument The FCC states that a 50 ohm 50 micro Henry LISN should be used Both sides of AC line were checked for maximum conducted interfer
48. 03 and ISO9001 2008 Certificated with Medical device GMP Taiwan M Approval for Class I Medical Device by Ministry of Health a and Welfare Taiwan Magnetic Immunoassay Analyzer 1 Sign up distribution agreements for bio functionalized une 2014 magnetic nanoparticles and micro beads in US and Malaysia Establish Animal Room mice for manufacturing July Mem monoclonal antibodies September Initiate internal control audit system Award with Excellent Incubated Industry issued by Ministry November of Economics Taiwan 1 2 Introduction of product The Magnetic Immunoassay Analyzer XacPro E designed by MagQu Co Ltd 1s 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 E can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility which is so called immunomagentic reduction The details of XacPro E are described in this report 1 2 1 Outward Appearance of XacPro E The picture of XacPro E is shown in Fig 1 XacPro E is 700 mm in width 610 mm in depth and 610 mm in height The input electricity is 100 240 VAC 50 60Hz Fig 1 Photo of magnetic immunoassay analyzer XacPro E 1 2 2 Mechanism of Immunomagnetic Reduction The Magnetic Immunoassay Analyzer XacPro E utilizes the so called immunomagnetic reduction IMR as its assay princi
49. 2009 A1 2010 EN 61000 3 2 2006 A1 2009 A2 2009 EN 61000 3 3 2008 IEC 61000 4 2 2008 IEC 61000 4 3 2006 A1 2007 A2 2010 IEC 61000 4 4 2012 IEC61000 4 5 2005 IEC 61000 4 6 2008 IEC 61000 4 8 2009 and IEC 61000 4 11 2004 The following manufacturer is responsible for sole responsibility for this declaration Company Name MagQu Co Ltd Address 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Tatwan Signature Print Name Title CE Date Place October 16 2013 Taiwan 12 2 EU representative contract Chapter 13 Applied Standards 13 Applied standards 13 1 QMS Related EN ISO 13485 2012 13 2 Medical Device EN ISO 14971 2012 Quality Systems Medical devices System requirements for regulatory purposes Medical devices Application of risk management to medical devices 13 3 IVD medical equipment EN61010 1 2010 EN61010 2 101 2002 EN61326 1 2006 EN55011 2009 13 4 IFU amp Label EN 15223 1 2012 Safety requirements for electrical equipment for measurement control and laboratory use General requirements Medical electrical equipment Part 1 2 General requirements for safety Collateral standard Electromagnetic compatibility Electrical equipment for measurement control and laboratory use EMC requirements General requirements Industrial scientific and medical equipment Radio frequency disturbance characteristics Limits and methods of measuremen
50. 38 e j s ven OF Ge 12 58 3 4t N ct Du SOOO EG BR BS eS ERROR AER OUESERLOUUURSHA2300 P AN EMENI nr ED am ont s 3 Se C E A M S 7 R ce RR BHA UE HORE dE spe M 1 Ab GALS j SSaeeow Ak NJ 27 lt gt t Xr v Y N J MK 001905 Chapter 2 Essential Requirements Checklist Description General requirements m Appli cable or not 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 safety 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 YES Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN 61010 1 2010 EN 61326 1 2006 the patient and are compatible with a high level of protection of health EN 55011 2009 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 adop
51. 42 x OS ndo eio E MERE 42 12 2 Test Severity Levels P 42 12 3 Measurement EgUPMENi ssiirsissii eanesucieiaaecaausausiad YUEUS enia rici bwuiek acer baaieed Uv ns dex a Ric Ew YR pO zc wi Ead 42 12 4 Test Res lt and D Old ausoneminneccidenberksid reed usua dUR Um dU DRURI ERE QrwIERL Uri EUR PPI RUD IN DENS niiina iiaeiai 43 12 9 OSUPTIOIQDUIGDIIS secuntur presa meph rmdd EEEE ha MUN IER ERIT ean tailbenstaatadenca 44 13 Power Frequency Magnetic Field Immunity Test ee eese eeeee ee eeee eene nnne nnn nnne 45 Tois TOS SC UID eb cE EQ 45 Toe TeSt eventy LEVES nena eee eee eer 45 13 3 Measurement Equipment essiens renki nnna a n a aN EERE EAE EAEE ETE naV E EREEREER 45 134 Test Result and Dala esinedes E E AO a 46 toa PROON aD ETE 47 14 Voltage Dips and Voltage Interruptions Immunity Test Setup eere eese 48 Teke oS CONIO RERO Em 48 14 2 Measurement EQuipment cccccccccccsssececseseeecseeeceeeeeseeeseaeeeeeseeseeeseaueeessaeeesseeeeessgeeeessaneessnaeeees 48 14 3 Test Result and Data cccccccccccssseeeeceseeeesaeeeeecseeeceeseaseeessaeeeeseaseeeseaeeeessaaeeesseeeeesseeeessaneeesaageees 49 TEA ASST OO OAD INS cvenetenbulcxgntdcepttDleen BN E SRUPGETONN UR VQ CR CURE CEO RUE QUU 50 Appendix A Photographs of EU T i siscxsseso us nionnu unti DU E muu DERE aaa
52. 50 mJ stored energy for voltages above 15 kV peak or d c Primary means of protection O D ACCESSIBLE parts prevented from being HAZARDOUS Enclosures and barriers LIVE by one or more of following means surrounding the hazardous a ENCLOSURES or PROTECTIVE BARRIERS see 6 4 2 b BASIC INSULATION see 6 4 3 live meet the rigidity requirements O Ix lt T1303269 762 gt Page 14 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict c Impedance see 6 4 4 Not protect by impedance N A 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 CLEARANCES between ACCESSIBLE parts and HAZARDOUS live parts if protection is provided by limited access meet CLEARANCE CREEPAGE DISTANCE and solid insulation requirements of 6 7 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 6 5 1 Additional means of protection in case of SINGLE FAULT CONDITION ACCESSIBLE parts are prevented from becoming HAZARDOUS liv
53. 7 6 1 2 6 3 1 Values in NORMAL CONDITION see NOTE 1 11 3 Spillage 6 6 2 11 4 Overflow 6 10 3 Plugs and connections Voltage 10 5 5 s test NOTE see V V V Test mA mA mA Form A 6 r m s peak d c circuit r m s peak d c uC mJ V uC mJ A1 A2 A3 e a e ee ee NOTE A 10 s test is specified in 6 1 2 a b A 5 s test is specified in 6 10 3 The capacitance level versus voltage below the limits given from figure 3 of IEC 61010 1 Exceptions 11 2 Cleaning and decontamination Terminals for external circuit Supplementary information lt 1303269 762 Page 47 of 66 O IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark 6 32 TABLE Values in SINGLE FAULT CONDITION Form A 8 Pp a Subclause Voltage Transient Current Capacitance and see NOTE see fault No Test mA uF Comments Form A 6 see Form A 2 r m s ae circuit r m s ben d c see NOTE A1 A2 A3 eet ee a ee ee ee ee ee eee 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 T1303269 762 Page 48 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict 6522 TABLE Cross sectional area of bonding conductors Form A 9 PO CONDUCTOR LOCATION CROSS SECTIONAL AREA VERDICT mm GND pin of inlet to enclosure 0 8mm TABLE Bonding
54. 79 12 1 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 RD02 energy radiation The device is a low voltage device and never generates high energy radiation eliminate or reduce as far as possible consequent risks Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 12 1 a For devices which incorporate software or which are medical software No in themselves the software must be validated according to the state of the art taking into account the principles of development lifecycle risk management validation and verification Description 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 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
55. 86 2 86671809 Appendix A Structural Block of XacPro E301 Dimensional drawing of Magnetic Immunoassay Analyzer XacPro E301 is shown as the following Detection Box AS t 450mm 7T00mm si RM ZIEEREHHITTITTT ITI O S Hu Temperature Box 420609 8 dr m i Ere X Net weight 15 8 kg MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 26 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Appendix B Specifications of XacPro E301 MagQu Co Ltd Refer to Addendum A for detailed dimensions of the analyzer Specifications of the power converter Input 100 230 VAC Output Max 24VDC 200 W Specifications of AC Wave Generator Output power AC 3V to AC 24V 50mA 50mA Output Frequency 100 to 50 kHz Specifications of amplifier circuit Wave band 1 k to 30 kHz Voltage magnification to 2000 Specifications of solenoid assembly Excitation coil resistance 100 200 Q coil density 400 550 turns cm Pick up coil resistance 40 70 Q coil density 400 550 turns cm Software platform Windows XP Windows 7 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 2 Appendix C List of Packing Inserts MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road
56. 86671897 Fax 4886 2 86671809 URL waw magqu com Email i 3 Please wait for installation 4 Click Finish and end the installation XacPro E 3B XacPro E Setup XacPro E has been successfully installed Cick the Firesh button to ext this nstalation ee AF No 14 Lane 130 MinCyuan Rd Xindian District New Taipei City Taiwan Tel 886 2 86671897 Fax 8856 2 66671809 URL www magqu com Email info magqu com MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 1 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 gt Enter the Adlink file folder and double click Setup file Ze ta HE bs pat X 4 BRIA BBS 10 J Bin 2012 1 31 FF 0 BAK J Driver Installation 2012 1 4 EF ll BRBAX J Manual 2012 1 3 FF 05 fEZHX Software Package 2012 1 18 FF 0 BREBAR A ADLink 2000 1 14 FF 0 BF 2 KB AUTORUN 2001 2 23 EF 1 HBA 1KB A Readme 2012 1 12 FF 0 Adobe Acrobat 39 KB 2010 10 12 FF HRs 32 KB 1 SETUP 2001 5 15 FF 0 BRE 1 KB A SiX Steps To Get Started 2009 4 30 F 1 Adobe Acrobat 2 372 KB 6 Double click USB DAQ Module ds MagQu Co Ltd y C perm pe A EEHTGH STE ce Mullion All in owe DVD A DAGPilot Task orlemied DAG Oriver ond SDK DAQMaster ADLINK Six Steps to Get Started System manager for ADUNK DAQ Cards AD Logger USB DAQ
57. ATION between MAINS parts of opposite see Form A 14 polarity provided Devices not in the protective conductor Not be fitted in the protective conductor Fuses or single pole circuit breakers not fitted in neutral Not fitted in Neutral multi phase 6 2 PERMANENTLY CONNECTED EQUIPMENT Not a permanently connected equipment Overcurrent device Fitted within the equipment or ST N co A A A A A A A A A A A A A A A A A lt T1303269 762 gt Page 32 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark N A Specified in manufacturer s instructions a Other equipment Oooo o Protection within the equipment Provided in the adapter EQUIPMENT TEMPERATURE LIMITS AND RESISTANCE TO HEAT 10 1 Surface temperature limits for protection against burns i 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 table 19 in normal condition 0 B 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 function or Are marked with symbol 13 MEN N A Guards are
58. Attestation Number 1303269 Model No XacPro E301 Applicant MagQu Co Ltd Address 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan And in accordance to the following Applicable Directives Applicable to EUROPEAN COUNCIL DIRECTIVE 2004 108 EC The Information Technology Equipment That this product has been assessed against the following Applicable Standards EN 55011 2009 A1 2010 Group 1 Class A EN 61326 1 2013 EN 61000 3 2 2006 A 1 2009 A2 2009 EN 61326 2 1 2013 EN 61000 3 3 2008 IEC 61000 4 2 2008 IEC 61000 4 3 2006 A1 2007 A2 2010 IEC 61000 4 4 2012 IEC 61000 4 5 2005 IEC 61000 4 6 2008 IEC 61000 4 8 2009 IEC 61000 4 11 2004 CERPASS hereby acknowledges that The measurements shown in this test report may issue a DECLARATION of CONFORMITY and apply the CE mark in accordance to European Union Rules Cl FFT a I Attestation by doll Chen 2013 10 09 Hill Chen Date EMC RF B U Assistant Manager Approval of Class I Medical Device in Taiwan 7 MM been UJ m J a X eA 9 4 23 Be BS 14 E j AIA FR X LR ME HT Hop SX 005218 t J PLEI BE BE RIE ATR RIR A K He 30 5 FH MagQu Magnetic Immunoassay Analyzer Non sterile x W V MB Ft RAGUEBNSURASOGRGENOR RAZA SREHUROHARAS pats Sou N E 6 tr dL Rze w AD Ak OT Wis MSA RERMTARAD 7 f if e GA dd O 3g 75 jy JSURHObAL MILT AGE PEI 5
59. C CERPASS TECHNOLOGY CORP Report No TEEX1303269 1 Summary of Test Procedure and Test Results Immunity Radio Frequency electromagnetic IEG 61000 4 3 2006 A1 2007 A2 2010 PASS field immunity test RS Electrical Fast Transient Burst Immunity Test EFT IEC 61000 4 4 2012 PASS Surge Immunity Test IEC 61000 4 5 2005 PASS Conduction Disturbances induced by IEC 61000 4 6 2008 PASS Radio Frequency Fields Power Frequency Magnetic Field IEC 61000 4 8 2009 PASS Immunity Test Voltage Dips and Voltage IEC 61000 4 11 2004 PASS Interruptions Immunity Test 2 Immunity Testing Performance Criteria Definition Criteria A normal performance within levels specified by the manufacturer requestor or purchaser Criteria B temporary loss of function or degradation of performance which ceases after the disturbance ceases and from which the EUT recovers its normal performance without operator intervention Criteria C temporary loss of function or degradation of performance the correction of which requires operator intervention ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 6 of 50 C CERPASS TECHNOLOGY CORP Report No TEEX1303269 3 Test Configuration of Equipment under Test 3 1 Feature of Equipment under Test Please refer to the user manual 3 2 Test Manner a During testing the interface cables and equipment positions were varied according to Euro
60. Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 12 0f 50 o CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase NEUTRAL _ Dectection Box Temperature Box l Test Date Sep 30 2013 Humidity l ressure 100 0 dBuV Class A Conduction QP Class A Conduction AYG 50 c 0 0 30 000 0 150 MHz 0 5 5 Frequency Factor Reading Level Limit Margin Detector MHZ dB dBuV dBuV dBuV dB 1 0 1539 10 43 12 47 22 90 79 00 56 1 0 1539 10 43 18 27 66 00 47 73 AVG P F s s ose 1051 100 ss 79 00 se D Cn o Oo ololo D Qo O a A e e D lt Note Level Reading Factor Margin Level Limit AV 1 J NJ BIG C Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 130f50 CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase LINE Dectection Box Temperature Box l o Test Date Sep 30 2013 Humidity ressure 100 0 dBuV Class A Conduction QP Class A Conduction AVG 50 0 0 0 150 0 5 MHz 5 30 000 Mo Pane de auv asuv asov sy j MHz dB dBuV dBuV dBuV dB a f onoo noss sese 4524 79 00 2076 ap P_ 2 o 10 38 2537 s375 66 00 s2zs avo P L3 osso 10 28
61. 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 11 Certification of ISO 13485 2003 Tafa ME rer ote en yee A a E E emu veles uu n se Certificate TW14 10079 The management system of MagQu Co Ltd 3F No 12 Ln 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan R O C essed and certified as meeting the requirements of ISO 13485 2003 EN ISO 13485 2012 For the folawing activities Design and Manufacture of non sterile magnetic bea
62. Final Test Result PASS Pass performance criteria A Required performance criteria A Basic Standard IEC 61000 4 3 Product Standard EN 61326 1 Frequency Range 80 1000 MHz 1400 2000 MHz 2000 2700 MHz 10 V m unmodulated r m s 80 AM 1 kHz for 80 1000 MHz Field Strength Q9 V m unmodulated r m s 80 AM 1 kHz for 1400 2000 MHz 1 V m unmodulated r m s 80 AM 1 kHz for 2000 2700 MHz Temperature 25 C Relative Humidity 58 Atmospheric Pressure 1011 hPa Test Date Oct 03 2013 Modulation AM 80 1KHz sine wave Dwell time 3 S Frequency Step Size 1 96 of preceding frequency value Antenna Field strength 80 1000 Front Rear Left Right 10 V m 80 1000 Horizontal Front Rear Let Right 10Vm A 400 2000 Vedea Front Rear tof ight 3m A 400 2000 Horizontal Front Rear Lot ight ovim A 000 2700 Verteal Front Rear Lot Fight iVm A 2000 2700 Horizontal Front Rear Lot Row ivim A Note A normal performance within levels specified by the manufacturer requestor or purchaser Test engineer oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 34 of 50 m Lo Cc a CERPASS TECHNOLOGY CORP Report No TEEX1303269 9 5 Test Photographs ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 35 of 50 o CE C CERPASS TECHN
63. IMPEDANCE a RATED to disconnect the load within time specified in Figure 2 b RATED for the maximum load conditions of the equipment Current or voltage limiting devices N A 6 5 5 9 6 6 e gt Device complies with all of For the fuse a RATED to limit the current or voltage to the level of See Form A 8 6 3 2 b RATED for the maximum working voltage and Automatic disconnection of the supply No such device is used a appropriate single component suitable for safety and reliability for protection it is lt T1303269 762 gt Page 18 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark RATED for the maximum operational current if applicable C CLEARANCE CREEPAGE DISTANCE between see Form A 13 terminations of the impedance meet requirements of SUPPLEMENTARY INSULATION of 6 7 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 Complied with insulation TERMINALS for external circuits No terminals which are hazardous live TERMINALS which receive a charge from an internal see Form A 7 capacitor are not HAZARDOUS LIVE after 10 s of interrupting supply connection Circuits with terminals which are HAZARDOUS LIVE No terminals which are hazardous live Not connected to ACCESSIBLE conductive parts or Connected to ACCESSIBLE conductive parts
64. INS supply source and connections between parts of equipment 6 10 1 MAINS supply cords By means of appliance inlet N A RATED for maximum equipment current see 5 1 3c N A N A N A Green yellow used only for connection to PROTECTIVE CONDUCTOR TERMINALS Detachable cords with IEC 60320 MAINS connectors Temperature RATING cord and inlet Conform to IEC 60799 or N A Have the current RATING of the MAINS connector N A O NO Fitting of non detachable MAINS supply cords By means of appliance inlet N A L Inlet or bushing smoothly rounded or N A EE Insulated cord guard protruding gt 5D N A lt T1303269 762 gt Page 24 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Cord anchorage By means of appliance inlet N A O NO NO Protective earth conductor is the last to take the strain N A a Cord is not clamped by direct pressure from a N A screw b Knots are not used N A c Cannot push the cord into the equipment to cause N A a HAZARD i N A N N A method of strain relief is clear MAINS supply plugs connectors etc conform with By means of appliance inlet 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 60320 inlet is used rated SUPPLY voltage MAINS type plugs used only for connection to MAINS supply s
65. Labeling as listed in Table 7 1 Table 7 1 Packing materials of Carcinoembryonic Antigen CEA IMR Reagent Packaging materials Quantity Operating and maintaining manual 1 Set Labeling Set Chapter 8 Labels 8 Labels The labels for Magnetic Immunoassay Analyzer XacPro E are given 8 1 Labeling 8 2 Symbols Mag u Magnetic Immunoassay Analyzer Model MOcxacPro E Serial No E301 20150101 10 Io Rating 100 2300 5075 0Hz 1 5 D 8A M D 01 2015 Magiu Co Ltd z CEL re sce MedNet GmbH Made in Taiwan Borsada 10 48163 Minsier Germany This Way Up Caretul Fragile Keep Dry Away From Magnetic Field Away from the field 8 3 Operation amp Maintenance Manual Mag u Magnetic Immunoassay Analyzer XacPro E30 Operation amp Maintenance Manual Version 201309 MagQu Co Lid 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 Table of Contents Safety Instructions Environmental Considerations Chapter I Brief Introduction to Applications of Magnetic Immunoassay Analyzer 5 Chapter II Principle of Magnetic Reduction Immunoassay Chapter III Introduction of Magnetic Immunoassay Analyzer XacPro E301 Section I Power Converter AC DC Section II Dynamic Signal Processor DSP Section III Coils Section IV Signal Amplification Circuit Amplifier Sectio
66. N A Verdict N A c With maximum dose at 1 m or N N A 12 2 1 3 Equipment not intended to emit radiation Limit for unintended stray radiation of 1 uSv h at an s easily reached point kept 12 2 2 Accelerated electrons No accelerated electrons Compartments opened only by the use of a TOOL Ultraviolet UV radiation No ultra violet radiation N A A A Zi zr No micro wave generator Power density does not exceed 10 W m Maximum sound pressure level measured and A A N A A A N A N A N A 12 3 12 4 lt lt calculated for maximum sound power level as specified in ISO 3746 or ISO 9614 1 No ultrasonic pressure N A exceed limit of 110 dB between 20 kHz and 100 kHz between 20 kHz and 100 kHz and following information in the documentation N A N A Z D c o D lt T1303269 762 gt Page 36 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Equipment meets requirements of IEC 60825 1 PROTECTION AGAINST LIBERATED GASES EXPLOSION AND IMPLOSION Poisonous and injurious gases No such gases N A No poisonous or injurious gases or substances N A liberated in NORMAL CONDITION No laser source a a NEN a N A 13 13 1 Attached data test reports demonstrate conformity Equipment shall not liberate dangerous amounts of N A poisonous or injurious gases or substances in NORMAL
67. OLOGY CORP Report No TEEX1303269 10 Electrical Fast Transient Burst Immunity Test 10 1 Test Procedure a In order to minimize the effect of environmental parameters on test results the climatic conditions when test is carrying out shall comply with the following requirements e ambient temperature 15 C to 35 C relative humidity 45 to 75 e Atmospheric pressure 86 Kpa 860 mbar to 106 Kpa 1060 mbar b In order to minimize the effect of environmental parameters on test results the electromagnetic environment of the laboratory shall not influence the test results c The variety and diversity of equipment and systems to be tested make it difficult to establish general criteria for the evaluation of the effects of fast transients bursts on equipment and systems d Test on Power Line The EFT B generator was located on the GRP For floor standing equipment 1 0 m For table top equipment 0 5 m The EFT B generator provides the ability to apply the test voltage in a non symmetrical condition to the power supply input terminals of the EUT e Test on Communication Lines he coupling clamp is composed of a clamp unit for housing the cable length more than 3 m and was placed on the GRP he coupling clamp provides the ability of coupling the fast transient bursts to the cable under test f The test results may be classified on the basic of the operating conditions and the functional specification of the equipment
68. R values for the normal control group are within the range 0 6 ng ml to 1 5 ng ml but the 9CEA IMR values for CRC patients range from 6 0 ng ml to 20 ng ml An analysis of the receiver operating characteristic ROC curve shown in Figure X b shows that the threshold for the diagnosis of CRC by an assay of CEA in serum using the IMR method is 4 05 ng ml which results in the clinic sensitivity of 0 90 and a specificity of 0 87 e Normal control CRC 0 1 1 0 10 0 0 0 02 0 4 DE Pcea mr Ng mi 1 specificity Fig X a Measured CEA concentration cgA pug using IMR CEA reagent and analyzer for normal subjects normal control and patients with colorectal cancer CRC b The ROC curve for the analysis of the clinical sensitivity and the specificity for the diagnosis of colorectal cancer using the detected CEA concentration 9CEA IMR in serum Reference Che Chuan Yang Shieh Yueh Yang Chia Shin Ho Jui Feng Chang Bing Hsien Liu and Kai Wen Huang Development of antibody functionalized magnetic nanoparticles for the immunoassay of carcinoembryonic antigen a feasibility study for clinical use Journal of Nanobiotechnology 2014 12 44 Chapter 7 Package 7 Package The package information for Magnetic Immunoassay Analyzer XacPro E is given 7 1 Packaging Materials of Product The packaging materials of Magnetic Immunoassay Analyzer XacPro E include Analyzer Operating and maintaining manual and
69. RCUITS is achieved by a transformer providing REINFORCED INSULATION DOUBLE INSULATION screen connected to the PROTECTIVE CONDUCTOR No such parts N A TERMINAL a meet the values of Table 6 for BASIC INSULATION and SUPPLEMENTARY INSULATION twice the values of Table 6 for REINFORCED 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 are 1 6 times Complied with the R I test N A the values for BASIC INSULATION 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 DEGREE 2 and 0 8 mm for POLLUTION DEGREE 3 Based on WORKING VOLTAGE meets the values of Table 7 for BASIC and SUPPLEMENTARY INSULATION Values for REINFORCED INSULATION are twice the values 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 N A N A Withstands electrical and mechanical stresses in normal use and all RATED environmental conditions of 1 4 a Equipment passed voltage test of 6 8 3 1 for 5s 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 R I test values of BASIC INSULATION lt T1303269 762 gt Page 22 of 66 OQ IEC EN 61010 1
70. RESPONSIBLE BODY for eliminating or reducing HAZARDS involved in removal from use transportation or disposal These instructions shall include requirements for minimizing biohazards IEC 61010 2 101 Transport and storage IEC 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 IEC 61010 2 101 O1 on T D L oO oO N PROTECTION AGAINST ELECTRIC SHOCK 1 General see Form A 5 lt T1303269 762 gt Page 12 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict O 1 1 Requirements Protection against electric shock maintained in NORMAL In normal and single fault CONDITION and SINGLE FAULT CONDITION 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 O 1 2 Exceptions Following HAZARDOUS LIVE parts may be accessible to an OPERATOR No hazardous liv
71. Report No TEEX1303269 T Voltage Fluctuations Test 7 1 Test Procedure The equipment shall be tested under the conditions of Clause 5 The total impedance of the test circuit excluding the appliance under test but including the internal impedance of the supply source shall be equal to the reference impedance The stability and tolerance of the reference impedance shall be adequate to ensure that the overall accuracy of 8 is achieved during the whole assessment procedure 7 2 Measurement Equipment Instrument Manufacturer Model No Serial No Calibration Date Valid Date PONGFSCRGIHOUIGS TTI HA1600 198226 2013 09 13 2014 9 12 Analyzer il Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 25 of 50 7 3 Test Result and Data Final Test Result PASS Basic Standard EN 61000 3 3 Temperature 25 C Test Data Oct 03 2013 Relative Humidity 58 96 Dectection Box Supply Voltage 233 9 to 234 1 Vrms 330 3 Vpk Frequency 50 03 Hz THD O 7 Crest Factor 1 411 peak at 94 0 deg Load Power 0 004 kW 0 007 KVA Power Factor 0 701 Load Current 0 03 to 0 03 Arms 0 07 Apk Crest Factor 2 389 Voltage Variations Highest Half cycle level 1 87 Lowest Half cycle level 1 63 d max 0 24 Pass Number of Change Intervals 1 Highest d t for 500 ms 0 00 Pass Longest d t over 3 30 0 00 seconds Steady State definition gt 1000 ms below 0 32 H
72. S do not apply 1 maximum TRANSIENT OVERVOLTAGE is limited to known level below the level of MAINS CIRCUIT 2 maximum TRANSIENT OVERVOLTAGE above the level of MAINS CIRCUIT 3 WORKING VOLTAGE is the sum of more than one circuit or a mixed voltage 4 WORKING VOLTAGE includes recurring peak voltage may include non sinusoidal or non periodic waveform N A N A N A N A 5 WORKING VOLTAGE with a frequency above N A 30 kHz 7 2 Insulation for MAINS CIRCUITS of OVERVOLTAGE CAT Il and not over 300V D D D D D N N N N N O1 A oo NO O CATEGORY II with a nominal supply voltage up to 300 V CLEARANCES and CREEPAGE DISTANCES see Form A 13 e ii lt T1303269 762 gt Page 20 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Values for MAINS CIRCUITS of table 4 are met CAT Il and not over 300V Coatings to achieve reduction to POLLUTION DEGREE Pollution 2 is considered N A comply with requirements of Annex H Solid insulation Withstands electrical and mechanical stresses in normal use and all RATED environmental conditions of Equipment passed voltage tests of 6 8 3 with values of see Form A 14 Table 5 Complies as applicable 4 um ENCLOSURE or PROTECTIVE BARRIER Clause 8 Jp Jo moulded and potted parts requirements of 6 7 2 2 2 No potted part c inner layers of printed wiring boards requirements
73. So the ac magnetic signal Ya 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 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 In Chapter III every component of XacPro E301 will be described in detail Xac o Xac o lt Xac o P 4 y icis AX sot XY M Q a a p a BOE SE Wo M CES JA y5 ut RY bs ZARY JA Ys AX Kj aa 7 ww lt uU lt 7 lt lt TA Kr JA roa rie 1K LT dh Pos LFU M Me 7E fw ly fe AA TAN AY 2 ZO d mut WOK SOM UR E ONT TAE TW TAN TAN MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 6 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Chapter III Introduction of Magnetic Immunoassay Analyzer XacPro E301 Picture and scheme of XacPro E301 is as shown in Fig 1 XacPro E301 is consisted of two modules 1 Detection Box AC DC DSP Coils Amplifiers Micro Control unit and TE cooler indicated by Fig 1 2 Temperature Control Box Electronics shown in Fig 1 Specifications and functions of these two mod
74. Taipei City 231 Taiwan 1 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 12 Click exit and X to finish the installation MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Tryarr id Ln Pyne Measurement ce AULOM aol ADLINKUSBDAQ DAGPilot Task odented DAQ Driver and SDK DAQMaster System manager for ADUNK DAG Cards U Test USB DAG Testing Application Software Package Driver Installation ADLINK on Web Manual E Reodme E Contact Us Ca fr Measurement Automatior ADLINK S All in one DVD ADLINI DAGPilot Task onented DAG Driver and SDK DAQMaster Six Steps to Get Started System manager for ADLINK DAG Cards AD Logger USB DAQ Module Configuration based Data Logger 30 days trial USB 1901 1902 1903 41D DAQBench ActiveX Controls for Test Measurement Software Package Driver Installation dissitis ADLINK on web Manual EJ Reodme E Contect Us www odlinktech com MAPS 18 Section II Setting amp Start up Procedure of XacPro E301 1 XacPro E301 is consisted of a temperature control box and detection box Please put the detection box on a flat table gently at first then place the temperature box on it or a flat table gently 2 There are three switches on the back of temperat
75. Technical Documentation for IVD According to the IVD Medical Devices Directive 98 79 EC Related to Magnetic Immunoassay Analyzer Products Device designation Catalogue number Magnetic Immunoassay Analyzer XacPro E Writer Reviewer Approver Document number Outline Introduction Essential Requirement Checklist Risk Management Design Master File lest Reports Clinical Evaluation Report Package Labels Manufacturing e 0 10 Un BwWN 10 Vigilance System 11 Conclusion 12 Declaration of Conformity 13 Applied Standards Chapter Introduction 1 Introduction Hereby this Technical File to be a statement of Magnetic Immunoassay Analyzer and manufacturing process are functional and with well quality This Technical File include thirteen chapters which illustrate manufacture technical document relevant test reports certificates package labels and some advertising materials 1 1 Introduction of Company MagQu Co Ltd was founded in early 2008 in Taiwan with a group of professional physicists and medical doctors MagQu owns IP s and the ability to prepare versatile anti bodies antigens single strain DNA coated magnetic beads for magnetically labeled bio detection These magnetic beads are referred as to immunomagnetic beads particles Besides MagQu offers two types of analyzers electronic XacPro E and superconductive XacPro S for assays Through our proprietary methodology so calle
76. The sales or agent should do setting training to operators while the device first setting Every single part of product which transports power should be 4 accessed by safety guild to Z 2 prevent any harm to operators while functional failure Acceptable 1 6 Risk Benefit Comparison The risk management report demonstrated the benefit of XacPro E made by MagQu Co Ltd is better than risk to use it 1 7 Residual Risk Evaluation According to risk analysis process and management the residual risk 1s low and can be acceptable 1 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 1 9 Conclusion According to above risk management report the magnetic immunoassay analyzer XacPro E 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 Prepared by Approved by Dated 1 Risk management report Summary MagQu Co Ltd Risk Management Report Comply with ISO 14971 2007 Product Name Magnetic Immunoassay Analyzer XacPro E Report Date 2015 02 16 A Information Company Name MagQu Co Ltd Company Address 3F No 12 Lane 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Product Nam
77. The two excitation coils and the pick up coil are assembled co axially The AC magnetic signals generated by the magnetic reagent are sensed by the pick up coil and are guided to the amplifier and feedback control circuit section IV Signal Amplification Circuit Amplifier Actually AC magnetic signals generated by the magnetic reagent and sensed by the pick up coil are consisted of weak signals at multiple frequencies For the purpose of amplifying the weak signals at specific frequency which is to be measured the amplifier is adopted to filter and amplify the signals sensed by the pick up coil Section V Signal Output Module Micro control 1 Circuit Diagram Circuit diagram of the micro control is shown as Fig 5 The amplified signals are input by DSP and output to the computer USB to PC in Fig 5 after passing through the micro processor MCU in Figure 5 and USB signal output converter DAQ Fig 5 Diagram of Micro control 2 Function When the amplified signals are input at terminal P8 of DSP shown in Fig 5 the instantaneous signals will be converted MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 10 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 into spectrum signals in DSP and MCU Then the signal at specific frequency will be selected out by MCU and input to the external computer XacPro E301 is connected t
78. Vac Pass SELV NOTE 1 Type of insulation NOTE 2 Types of voltage NOTE 3 INSTALLATION CATEGORIES Bl BASIC INSULATION Peak impulse test voltage pulse OVERVOLTAGE CATEGORIES DI DOUBLE INSULATION r m s Or POLLUTION DEGREES which differ from PI PROTECTIVE IMPEDANCE d c these should be shown under Comments RI Reinforced INSULATION peak SI Supplementary INSULATION Supplementary Information lt T1303269 762 Page 45 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE List of ACCESSIBLE parts Form A 6 c Description Determination method Exception under 6 1 2 NOTE 5 NOTE 4 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 3 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 A 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 1303269 762 Page 46 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict TABLE Values in NORMAL CONDITION Form A
79. Yang Chia Shin Ho Jui Feng Chang Bing Hsien Liu and Kai Wen Huang Development of antibody functionalized magnetic nanoparticles for the immunoassay of carcinoembryonic antigen a feasibility study for clinical use Journal of Nanobiotechnology 2014 12 44 Chapter 5 Test Reports 5 1 Particular requirements for in vitro diagnostic IVD medical equipment lt T1303269 762 Page 1 of 66 OQ TEST REPORT IEC EN 61010 1 amp IEC 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 11303269 762 Tested by printed name and signature Wison Huang Approved by printed name and signature Jasson Shiu Date of issue October 21 2013 Testing Laboratory name CERPASS TECHNOLOGY CORP Address eeeesseeeseeeeeeeernes 9f No 200 Gangcian Rd Neihu District Taipei City 114 Taiwan Testing location as above Applicant s Name MagQu Co Ltd POQUCS S socctechicncetsescet eee ete eee 4F No 14 Ln 130 Minquan Rd Xindian Dist New Taipei City 231 Taiwan R O C Test specification Standard IEC EN 61010 1 2010 and IEC EN 61010 2 101 2002 Test procedure IVD LVD Verification Report Procedure deviation NA Non standard test method NA Test Report Form No IEC61010
80. _Risk Management Report No RM02 02 Product research files XacPro E 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 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 cable 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 17 Standard Sub clause s Report Document Comments ISO 13485 Quality System Cert No TW 14 10079 _Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validatio
81. afe combination d all the information needed to verify whether the device is properly installed and can operate correctly and safely plus details of the 22 Standard Sub clause s Directive 98 79 EC ISO 13485 2012 EN 61010 1 2010 EN 61010 2 101 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 Report Document ISO 13485 Quality System Cert No TW 14 10079 Product Master file No MF02 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No MF07 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 Product Master file No MF02 Product user Manual XacPro E ver 201309 Comments g 1 k l m n O p and q are excluded Clause Description e where appropriate information to avoid certain risks in connection f g h Q nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times with implantation of the device information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment the necessary instructions in the event of damage to the sterile packaging and where appropriate details of appro
82. al RISK is posed the identification of detachable components by manufacturer and part identification and where appropriate the batch code etc IEC 61010 2 101 Stated in the manual iv any expiry date of consumable parts expressed as N A the year the month and where relevant the day in that order IEC 61010 2 101 Eapen mereda 7 1 a c RATED MAINS frequency or range of i gz eln ee adpater 2 d c with symbol 1 b RATED supply voltage s or range 100 240V c Max RATED power W or VA or input current See page 1 lt 11303269 762 gt Page 5 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark The marked value not less than 90 of the see Form A 3 maximum value Sewweeemaedo Portable equipment indication is visible from the exterior 3 N A N A 3 N A N A N A N A Changing the setting changes the indication N A i N A N A N A N A N A N A Verdict i D c o D e Accessory MAINS socket outlets accepting No mains socket outlet standard MAINS plugs are marked With the voltage if it is different from the MAINS supply voltage cesses For use only with specific equipment If not marked for specific equipment it is marked NENNEN with The maximum rated current or power or Symbol 14 with full details in the documentation Operator replaceable
83. art of the equipment is removable by the operator exempted as removable part carries MAINS SUPPLY INPUT For the appliance inlet connection Any moveable PROTECTIVE BONDING connection No moveable PE gp designed and meets 6 5 2 4 No external metal braid of cables used No such cables is used not regarded as PROTECTIVE BONDING Means provided for passing protective conductor i h Protective conductors bare or insulated Green Yellow wires are if insulated green yellow used eu d or 2 internal protective conductors etc PN Green yellow not used for other purposes TERMINAL suitable for connection of a PROTECTIVE CONDUCTOR and meets 6 5 2 3 6 5 2 3 PROTECTIVE CONDUCTOR TERMINAL The ground of the appliance inlet is considered as the PE TERMINAL a Contact surfaces are metal Closed loop metal ring terminal Appliance inlet used See appended table 14 1 approved of components c Forrewirable cords and PERMANENTLY CONNECTED Appliance inlet is used EQUIPMENT PROTECTIVE CONDUCTOR TERMINAL is close to MAINS supply TERMINALS d lf no MAINS supply is required any PROTECTIVE Connected to mains supply N A CONDUCTOR TERMINAL lt T1303269 762 gt Page 16 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Is near terminals of circuit for which protective N A earthing is necessary External if other terminals external NENNEN N A e Equivalent current car
84. ator and other equipment utilized test level voltage current generator source impedance internal or external generator trigger number of tests at least five positive and five negative at the selected points repetition rate maximum 1 min inputs and outputs to be tested representative operating conditions of the EUT sequence of application of the surge to the circuit phase angle in the case of AC power supply actual installation conditions for example AC neutral earthed DC or earthed to simulated the actual earthing conditions d If not otherwise specified the surges have to be applied synchronized to the voltage phase at the zero crossing and the peak value of the AC voltage wave positive and negative e The surges have to be applied line to line and line s and earth When testing line to earth the test voltage has to be applied successively between each of the lines and earth if there is no other specification f The test procedure shall also consider the non linear current voltage characteristics of the equipment under test Therefore the test voltage has to be increased by steps up to the test level specified in the product standard or test plan g Alllower levels including the selected test level shall be satisfied For testing the secondary protection the output voltage of the generator shall be increased up to the worst case voltage breakdown level let through level of the primar
85. ausing mechanical damage to touch the EUT After each discharge the ESD generator discharge electrode shall be removed from the EUT The generator is then retriggered for a new single discharge This procedure shall be repeated until the discharges are completed In the case of an air discharge test the discharge switch which is used for contact discharge shall be closed oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 29 of 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 8 2 Test Setup for Tests Performed in Laboratory Typical position for direct discharge to EUT Typical position for indirect discharge to VCP Typical position for indirect i Insulatin discharge to HCP support g Horizontal coupling plane BA HCP 1 6 x 0 8m Protective conductor WY Insulating a S Ground reference es plane GRP em si supply The test setup consists of the test generator EUT and auxiliary instrumentation necessary to perform DIRECT and INDIRECT application of discharges to the EUT as applicable in the follow manner a CONTACT DISCHARGE to the conductive surfaces and to coupling plane b AIR DISCHARGE at insulating surfaces The preferred test method is that of type tests performed in laboratories and the only accepted method of demonstrating conformance with this standard The EUT was arranged as closely as possible to arran
86. ble Non Shielded 1 8m Mouse DELL MOC5U0 Data Cable USB Shielding 1 85m Power Cable Non Shielded 1m PHBISE PEDON Data Cable USB Shielding 1 6m Device Model No Notebook Satellite L730 Power Cable Non Shielded 1 8m Use Cable Shielding 1 8m Shielding 0 8m il o RS232 0 15 Pin Com Port Shielding 0 8m ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 8of 50 o Ce CERPASS TECHNOLOGY CORP Report No TEEX1303269 3 4 General Information of Test Cerpass Technology Corp 2F 11 No 3 Yuan Qu St Nankang Software Park Taipei Taiwan 115 R O C No 68 1 Shihbachongsi Shihding Township OATS2 SD Taipei City 223 Taiwan R O C T 1173 for Telecommunication Test C 4139 for Conducted emission test R 3428 for Radiated emission test G 97 for Radiated emission test above 1GHz Frequency Range Radiated emission test from 30 MHz to 1 000 MHz Investigated Radio frequency electromagnetic field immunity test 80 2700 MHz The test distance of radiated emission below 1GHz from antenna Test Distance ie o d UE The test distance of radiated emission above 1GHz from antenna to EUT is 3 M 3 5 Measurement Uncertainty Measurement ltem Measurement Frequency Uncertainty Conducted Emission 9 kHz 30 MHz LINE NEUTRAL 3 25 dB VCCI Registration Number 30 MHz 1 000 MHz Vertical Horizontal 3 93 dB Radiated Emission 1
87. c epi de Kcense agesenient Reset lt Back Mew gt Cred 3f fu F4 Lane 1 36 MnCyuan RA Araun Diswict Ne Talse City Talia MagQu Co Ltd Teli MM amp 2 8667 M7 fae 885 2 86671809 URL wee reagan com Enait infoftnsgon com 3F No 12 Lane 538 ZhongZ Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 31 Taiwan 1 1 Set the installing pathway and click next XacPro E i NI LabVIEW Run Time Engine 7 1 Setup Destination Folder Select a loider where the application vil be inzteled ENSTRUMINTS The Wise Installation Wizard wil install the Hes for NI LabVIEW Run Time Engine 7 1 in the tollowing folder To install into a difeseri folder ckck the Browse button and select another folder You cen choose not to instal NI LabVIEW Run Time Engine 7 1 by chcking Cancel to ext the Wise Installation Wizard Destination Folder C Program Files National InstrumensSSharedNL abVIEW 7 1 Bowes 4F No 14 Lane 130 MinCyuen Rd Xindian District New Taipei City Taiwan Tal 4886 2 86671897 Fax 4886 2 86671809 URL ww magqu com Email info magqu com i NI LabVIEW Run Time Engine 7 1 Setup Ready to install the Application Cick Nest to begin instalation OE NSTRUMENTS Click the Back button to reerter the instalation m ormalion or cick Cancel to exit the wizard AF No t Lane 130 MinCyuan Rd Xindian District New Taipei City Taiwan Tel 4886 2
88. cause any incident 4 13 Regulatory authorities Any authority that provide certificate license to market the device such as FDA Notified body Health Canada etc 4 14 Corrective action An action to eliminate the cause of a potential nonconformity or other undesirable situation 4 15 Field Safety Corrective Action FSCA A field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market Such actions should be notified via a field safety notice The FSCA may include 4 15 1 The return of a medical device to the supplier recall 4 15 2 Device modification 4 15 3 Device exchange 4 15 4 Device destruction 4 15 5 Retrofit by purchaser of manufacturer s modification or design change 4 15 6 Advice given by manufacturer regarding the use of the device e g where the device is no longer on the market or has been withdrawn but could still possibly be in use 4 15 7 Permanent or temporary changes to the labeling or instructions for use 4 15 8 Software upgrades including those carried out by remote access 4 15 9 Modification to the clinical management of patients to address a risk of death or serious deterioration in state of health related specifically to the characteristics of the device 4 16 Field safety notice FSN An official communication to
89. ce Criteria C for voltage interruption B C for voltage dips Basic Standard IEC 61000 4 11 Product Standard EN 61326 1 Temperature 25 C Relative Humidity 58 Atmospheric Pressure 1011 hPa Test Date Oct 13 2013 Voltage UT AC 230 V Interval s 10s Times 3 Test level Durations a 0 0 5 30 25 Voltage interruptions 250 Note A normal performance within levels specified by the manufacturer requestor or purchaser C temporary loss of function or degradation of performance the correction of which requires operator intervention Test engineer oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 49 of 50 a CERPASS TECHNOLOGY CORP Report No TEEX1303269 C 14 4 Test Photographs ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 50 of 50 Fe Appendix A Photographs of EUT Dectection Box Cerpass Technology Corp Issued Date Oct 09 2013 _ Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No A1 of A6 o t CERPASS TECHNOLOGY CORP Report No TEEX1303269 C E M X amp Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No A2 of A6 M O CE a CERPASS TECHNOLOGY CORP Report No TEEX1303269
90. conformity with the essential requirements must include a clinical evaluation in accordance with Annex X Chemical physical and biological properties The devices must be designed and manufactured in such a way as to Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 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 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 Directive 98 79 EC Way ENISO13485 2012 as to minimize the risk posed by contaminants and residues to the ENISO14971 2012 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 Standard Sub clause s LLL Report Document ISO uc Quality System Cert No TW 14 10079 _ Product Master file No MF02 Risk Management Report No RMO2 02 Product user Manual XacPro E ver 201309 ISO 13485 Quality
91. d ImmunoMagnetic Reduction IMR MagQu provides a high sensitivity wash free easy operation color independence and on site test platform for quantitatively assaying proteins bacteria viruses DNA and other bio molecules in human agricultural aquatic and animal products Quality managements for both immunomagnetic beads and immunoassay analyzers are certificated with ISO 13485 2003 and ISO 9001 2008 In 2014 MagQu owns 18 employees 900 m in area office factory and NT 150 400 000 in capitals The contact information is shown in Fig 1 1 iil MagQu Co Ltd 3E No 12 Lane 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan Tel 886 2 8667 1897 Fax 886 2 8667 1809 E mail info magqu com Website www magqu com Fig 1 1 Contact information of MagQu Co Ltd 1 1 1 Company Profile e MagQu Co Ltd MagQu 3F No 12 Lane 538 Zhongzheng Rd Xindian Dist New Taipei City 231 Taiwan European Representative Company Name MedNet GmbH Address Borkstrasse 1048163 Muebster Germany Contact person amy qian medneteurope com Tel 49 251 32266 0 1 1 2 Business Items The business items of MagQu mainly include the design manufacture and sale of immunomagnetic bead reagents immunoassay analyzers and antibodies Product Name Certificate DoC Magnetic Immunoassay Analyzer XacPro E CE DoC MagQu Carcinoembryonic Antigen CEA IMR Reagent CE DoC 1 1 3 Company Milestone MagQu was found i
92. detach the analyzer discretionally contact the distributor if you need to repair it 4 Please use the original packing container when transporting the analyzer Section II After sale Services amp Guarantee 1 The product is provided with 1 year of free warranty term after sale MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 24 Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 2 As for the following cases the services will be charged properly even in the warranty term a Any damage or fault due to improper use or act of God such as lightning etc b Any damage or fault due to discretional repair modification or repair by any other third party c Any damage or fault due to change of installation location transportation or falling down etc 3 Please deliver the analyzer XacPro E301 to distributors when requiring repair As the analyzer is a precision instrument it must be transported carefully in compliance with the following instructions a Please use the original packing container for transportation b Convey shall not be conducted until the power is shut off c Prevent the product from pressing or falling MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 25 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 8
93. dity 58 Atmospheric Pressure 1011 hPa Test Date Oct 13 2013 Power Frequency Magnetic Field 50 Hz _30 A m Coil Orientation Testing duration Note A normal performance within levels specified by the manufacturer requestor or purchaser Test engineer il Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 46 of 50 a G Cc a CERPASS TECHNOLOGY CORP Report No TEEX1303269 13 5 Test Photographs ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 47 of 50 CE e CERPASS TECHNOLOGY CORP Repon DO ALE EA UO 14 Voltage Dips and Voltage Interruptions Immunity Test Setup 14 1 Test Conditions 1 Source voltage and frequency 100 230 240 50Hz Single phase 2 Test of interval 10 sec 3 Level and duration Sequence of 3 dips interrupts 4 Voltage rise and fall time 1 5 us 5 Test severity Voltage dips and Interrupt Test Duration reduction e 3 14 2 Measurement Equipment TESQ NSG3060 TESQ NSG3060 1385 2013 4 11 2014 4 10 il Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 48 of 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 14 3 Test Result and Data Final Test Result PASS Pass performance Criteria Bfor voltage interruption A for voltage dips Required performan
94. ds for bio assay separation and diagnosis Design and Manufacture 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 lssue 1 Certified since 27 January 2014 Authorised by 868 United Kingdom Ltd Systems amp Services Certification Rossmore Business Park Ellesmere Pot Cheshire CH65 EN UK teta 0 151 350 6656 f 44 0 151 350 6600 www sgs com 365 13485 2 0612 Ta docerert e iaai bythe Corby subject io Bt General Condtons v Cartfication Services accassibin at Lapeer derer awe Wie mia een ad juradicional imien satablsned therein The auhertety cf inia Kcd Barba wide prosecuted to the fies extent cf ihe n Page 1 of 1 elg V UKAS SYSTEMS 005 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 ISO 9001 2008 For the following activities Design and Manufacture of non sterile magnetic beads for bio assay separation and diagnosis Design and Manufacture of Magnetic Immunoassay Analyzer Further clanficabons regarding the scope of this certificate and tha apclicabliity of 150 9001 2008 requirements may be obtained by consulling the organisation This certificate is valid from 27 January 2014 un
95. e Magnetic Immunoassay Analyzer XacPro E Risk Management Representative Elvis Yang Risk Management Team Members Qualification At least 3 years related experiences and accept training more than 2 hours B Risk Management Flow Verification Q amp A that can be used to identify medical device characteristics that could impact on safety Possible hazards and contributing factors associated with Medical devices Risk Evaluations Analysis Control Ranking list FMEA Confirm the Benefits Overweight the Residual Risk C Post Market Surveillance During the life time 2015 2016 2017 2018 Year Engineering change Customer complaint CAPA NCAR Returned product Advisory notice Recall A to be happened but no impact the risk analysis result to be happened impact the risk analysis result X to be non happened Initial Prepared By Initial Reviewed By Initial Approval By job title job title job title 12 Chapter 4 Design Master File 4 Design Master File The design master file for Magnetic Immunoassay Analyzer XacPro E is given 4 1 Design Master File for Magnetic Immunoassay Analyzer XacPro E 4 1 1 Product Code and Illustration Product code XacPro E Product illustration The Magnetic Immunoassay Analyzer XacPro E 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
96. e content of the bio molecules in the samples So it is expected that XacPro E301 can be applied in the fields of in vitro quantitative detection including agriculture forest fishing stockbreeding food and human body MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 Chapter II Principle of Magnetic Reduction Immunoassay The Magnetic Immunoassay Analyzer XacPro E301 utilizes the so called immunomagnetic reduction IMR as its assay principle The principle of immunomagnetic reduction is described 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 Xac accordingly 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 is mixed with the sample number of swirling magnetic beads in the reagent driven by external field is much fewer
97. e by the primary means of protection and supplemented by one of a PROTECTIVE BONDING see 6 5 2 Class b SUPPLEMENTARY INSULATION see 6 5 3 automatic disconnection of the supply see 6 5 5 5 6 N A Alternatively one of the single means of protection is used 2 ice e REINFORCED INSULATION see 6 5 3 For the insulating parts f PROTECTIVE IMPEDANCE see 6 5 4 6 5 2 PROTECTIVE BONDING see Form A 9 A 10 and 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 A Separated by conductive screen or barrier bonded to N A PROTECTIVE CONDUCTOR TERMINAL 6 5 2 2 Integrity of PROTECTIVE BONDING C d current or voltage limiting device see 6 5 6 N gt z lt T1303269 762 gt Page 15 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict PROTECTIVE BONDING consists of directly connected Protective bonding are direct structural parts or discrete conductors or both and connected to structural parts withstands thermal and dynamic stresses Soldered connections Secured then soldered to earthing terminal of Appliance Inlet Independently secured against loosening Co Not used for other purposes Solely for earthing c Screw connections are secured Connections are secured against loosening d PROTECTIVE BONDING not interrupted or No p
98. e each condition Phase Voltage Mode Polarity Result Phase Voltage Mode Polarity Result Mode Polarity Result 2 0kV Note A normal t within levels specified by the manufacturer requestor or purchaser Test engineer E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 400f 50 a CERPASS TECHNOLOGY CORP Report No TEEX1303269 C 11 5 Test Photographs E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 41 of 50 o CE C CERPASS TECHNOLOGY CORP Report No TEEX1303269 12 Conduction Disturbances induced by Radio Frequency Fields 12 1 Test Procedure a The EUT shall be operated within its intended climatic conditions The temperature and relative humidity should be recorded b This test method test can be performed without using a sell shielded enclosure This is because the disturbance levels applied and the geometry of the setups are not likely to radiated a high amount of energy especially at the lower frequencies If under certain circumstances the radiated energy is too high a shielded enclosure has to be used c The test shall be performed with the test generator connected to each of the coupling and decoupling devices in turn while the
99. e generating antenna facing each of four sides of the EUT The polarization of the field generated by the broadband bilog antenna necessitates testing each position twice once with the antenna positioned vertically and again with the antenna positioned horizontally d The dwell time at each frequency shall not be less than the time necessary for the EUT to be exercised and able to respond Sensitive frequencies e g clock frequency ies and harmonics or frequencies of dominant interest shall be analyzed separately e At each of the above conditions the frequency range is swept 80 1000MHz 1400 2700MHz pausing to adjust the R F signal level or to switch oscillators and antenna The rate of sweep is in the order of 1 5 10 3 decades s The sensitive frequencies or frequencies of dominant interest may be discretely analyzed 9 2 Test Severity Levels Frequency Band 80 1000 MHz 1400 2700MHz Level Test field strength V m 2 3 10 X opecified Remark X is an open class 9 3 Measurement Equipment Nous eee 4231A 01 115902 2013 09 14 201 uA 3 Field Probe HOLADAY HI 6105 00144727 2013 09 20 2014 09 19 Signal Generator 8648C 3629U00612 2013 09 11 2014 09 10 51011 EMC 33312 2013 09 14 2014 09 13 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 33 of 50 o Ce CERPASS TECHNOLOGY CORP Report No TEEX 1303269 9 4 Test Result and Data
100. e never substances directly touches 12 8 1 Devices for supplying the patient with energy or substances must be P Her R designed and constructed in such a way that the flow rate can be set material or energy and maintained accurately enough to guarantee the safety of the pathway which can patient and of the user be imagined The device never directly touches patients in any material or energy pathway which can be imagined Devices must be fitted with the means of preventing and or indicating No any inadequacies in the flow rate which could pose 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 12 9 The function of the controls and indicators must be clearly specified Yes on the devices Directive 98 79 EC ISO 13485 Quality ENISO13485 2012 System Cert No ENISO14971 2012 TW 14 10079 Where a device bears instructions required for its operation or EN 61010 1 2010 indicates operating or adjustment parameters by means of a visual EN 61010 2 101 2002 _Product Master file No system such information must be understandable to the user and as MF02 appropriate the patient Risk Management Report No RM02 02 Product research files XacPro E Product user Manual XacPro E ver 201309 13 Information supplied by the manufacturer Directive 98 79 EC ISO 13485 Quality ENISO13485 2012 System C
101. e part is N A accessible a parts of lamps and lamp sockets after lamp No HV lamp N A removal b parts to be replaced by operator only by the use of No tool is needed N A tool and warning marking Those parts not HAZARDOUS LIVE 10 s after interruption see Forms A 6 N A of supply Capacitance test if charge is received from internal see Forms A 6 and A 7 N A capacitor Determination of accessible parts see Form A 6 General Unless obviously determination of accessible parts as specified in 6 2 2 to 6 2 4 Examination 2 2 with jointed test finger as specified B 2 Complied with the finger test with rigid test finger as specified B 1 and a force of Same as above 10 N 2 3 Openings above parts that are HAZARDOUS LIVE o D D N fo OD test pin with length of 100 mm and 4 mm in diameter applied OD 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 N A applied Limit values for ACCESSIBLE parts D D w w Levels in NORMAL CONDITION see Form A 7 lt T1303269 762 gt Page 13 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict 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 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 and
102. e selected test severity level in order to determine any threshold of failure The final severity level should not exceed the product specification value in order to avoid damage to the equipment d The test shall be performed with both air discharge and contact discharge On reselected points at least 20 single discharges in the most sensitive polarity shall be applied on air discharge On reselected points at least 20 single discharges in the most sensitive polarity shall be applied on contact discharge e For the time interval between successive single discharges an initial value of one second is recommended Longer intervals may be necessary to determine whether a system failure has occurred f In the case of contact discharges the tip of the discharge electrode shall touch the EUT before the discharge switch is operated g In the case of painted surface covering a conducting substrate the following procedure shall be adopted e If the coating is not declared to be an insulating coating by the equipment manufacturer then the pointed tip of the generator shall penetrate the coating so as to make contact with the conducting substrate e Coating declared as insulating by the manufacturer shall only be submitted to the air discharge The contact discharge test shall not be applied to such surfaces h In the case of air discharges the round discharge tip of the discharge electrode shall be approached as fast as possible without c
103. e time and if applicable also to the national competent authority responsible for the Authorized Representative The Field Safety Corrective Action Report form shall include all relevant documents necessary to monitor the FSCA 5 17 4 1 Relevant parts from the risk analysis 5 17 4 2 Background information and reason for the FSCA including description of the potential hazard 5 17 4 3 Description and justification of the action corrective preventive 5 17 4 4 Advice on actions to be taken by the distributor and the user in order to reduce the risks 5 17 4 5 Affected devices and serial lot numbers range explanation why other devices are not affected 5 17 4 6 Copy of the Field Safety Notice The QA manager shall inform the coordinating competent authority once the FSCA has been completed The report shall include information on the effectiveness of the action per country involved 5 18 Field Safety Notice FSN The field safety notice should be on a company letterhead and include the following 5 18 1 5 18 2 5 18 3 5 18 4 5 18 5 5 18 6 A clear title urgent field safety notice followed by the commercial name of the affected product The information defined in sections 5 17 4 1 5 17 4 5 Specific details to easily identify the affected products A request to pass the FSN to all those who need to be aware of it within the organization Confirmation that the relevant national competent au
104. easurement cccccceeeecceceseceeceeeceecceesceeceeeeeeeaueeeteeueeeesaeeeesaaes 24 62 TeS Ros ktand RD EIU 24 Te Voltage Fluctuations TeSt rsen 25 lle TEStPrOCedUTO eee eee ee E E E E E ee a a ee 25 7 2 Measurement EQUIDIMEM cciaricsvctviwiaceimassvcteavinsesatacsncdwaninoss ahatncbenarcamusausiadginaeraimbaeakiwaseerniasaindees 25 T3 Tesi TASS UN AIO Dala PTT 26 74A Tesi eee on mm m 28 8 Electrostatic Discharge Immunity Test ee eese eese eee ieeeen essen enne eren n nennen nhan nana nnn nnns 29 8 1 Test Proced re TS 29 8 2 Test Setup for Tests Performed in LAbDOratOry cccccccccssseeeeeeeeeeseeeeeeseeeeeeeeeeeeeesessaaeeeeeessaaeeeees 30 Gos TeS ot 2 E LOVES aereos ne nn eee ee eee eee ern Crete eee 30 8 4 Measurement EQUIDINGIN rcctieniansctrcsneeddnetancasandacmstaniunattueapmntheetetaaheetsueidceineatminnetbeviateaberiawerdieinkedisa 30 8 5 Test Result and Alaa E 31 B TES TOL GRAINS ereer EE a e E 32 9 Radio Frequency Electromagnetic Field Immunity Test ccccssssseeeesesseeeeesseeseenseeeeeeseeesoenseesenenees 33 9 1 Test Procedure RT 33 9 2 Test Severity Levels 0 0 ccccccccccssssceeeceesseceeecsseseeeeesaesseeeeeesaaeeeeessaaeeeeesseaaeeeessseaeeeesssaaseeessssagaeeess 33 9o Measurement EQUIDIMGIT cicisinepismcniercainevscectereeteimeueaiumaia
105. ed 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 13 Report Document Comments The device is a low voltage device and never generates high energy radiation The device 1s 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 Clause Description Appli Standard Sub clause s Report Document Comments cable or not 11 5 2 Devices emitting ionizing radiation intended for diagnostic radiology No The device is a low shall be designed and manufactured in such a way as to achieve appropriate image and or output quality for the intended medical purpose whilst minimizing radiation exposure of the patient and user voltage device and 11 5 3 Devices emitting ionizing radiation intended for therapeutic radiology No shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose the beam type and energy and where appropriate the quality of radiation never generates high 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 TW 14 100
106. ee Form A 10 N A EQUIPMENT Not permanently connected O O C O1 NO NO C A lt T1303269 762 gt Page 17 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Transformer provided with screen for protective No such screen is used N A bonding 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 A E gt Not used for other purposes SUPPLEMENTARY and REINFORCED INSULATION meet CLEARANCE CREEPAGE DISTANCE and solid insulation requirements of 6 7 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 6 5 3 0 4 6 s of the impedance meet requirements of DOUBLE or REINFORCED INSULATION of 6 7 The protective impedance consists of one or more of see Table 3 and Form A 12 the following N A N A N A RATED twice the maximum WORKING VOLTAGE 1 2 resistor RATED for twice the power dissipation for maximum WORKING VOLTAGE lt gt b combination of components N N A s oingle electronic device not used as PROTECTIVE
107. ence The frequency range from 150 kHz to 30 MHz was searched Set the test receiver system to Peak Detect Function and Specified Bandwidth with Maximum Hold Mode 2 Q gt ooo o E M M 89 Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 100f 50 CE e CERPASS TECHNOLOGY CORP Epon TNC TEPA UIO 4 3 Typical test Setup Hameo Hus s0rana07 20ans ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 11 of 50 o CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 4 5 Test Result and Data AC 230V 50Hz Pol Phase LINE Dectection Box Temperature Box l 5 Test Date Sep 30 2013 Humidity ressure 100 0 dBuV Class A Conduction QP Class A Conduction AVG 50 0 150 0 5 MHz 5 30 000 MHz dB dBuV dBuV dBuv dB 0500 1044 amp se 1880 7900 oz aP a oarso 1040 10 24 2064 0600 45 06 AVG Ls 04220 1020 102 927 7000 se7 oP 7 oora 1028 173 1201 7300 soss oP 7102940 1073 1901 2074 7500 4320 oP P_ 10 10 2040 1073 1708 zre 0000 219 Ave P m 190180 1106 3526 4036 7500 ese a 2 19 0100 1106 3162 269 0000 rra Ave F Note Level Reading Factor Margin Level Limit
108. ents cable 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 substances 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 1 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 patie
109. ept 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 XacPra E 301 Serial NO XacPro E 201308001 MQ Rating 100 240V AC 50 80Hz 1 5 0 8A M D 08 2013 MagQu Co Ltd IWww magqu com Made in Taiwan lt T1303269 762 gt Page 3 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Fault tests see Form A 1 and A 2 Application of SINGLE FAULT CONDITIONS SINGLE FAULT CONDITIONS not covered by 4 4 2 1 to see Form A 1 and A 2 PROTECTIVE IMPEDANCE No protective impedance PROTECTIVE CONDUCTOR Equipment or parts for short term or intermittent Continuous operate operation No motor capacitor Ss In the approved power unit Same as above lt Same as above No outputs Single supply Interlocks No interlock Voltage selectors No such parts Duration of tests see Form A 1 and A 2 Conformity after application of fault conditions see Form A 1 A 2 A 8 A 14 Incorrect voltage selection No voltage selection IEC 61010 2 101 MARKING AND DOCUMENTATION General o0 Required equipment markings are src Wevmompacwwoa omaso Weremosoagkoped N A N A N A
110. er 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 i ol Crag kag Signed by 4 Director General Food and Drug Administration for Wen Ta Chiu MD Ph D Minister Ministry of Health and Welfare Republic of China Taiwan Certificate of Compliance With European Low Voltage Directive No 11303269 762 Type of equipment Magnetic Immunoassay Analyzer Certificate holder MagQu Co Ltd Type designation XacPro E301 i Technical data 100 240 Vac 50 60H155 0 8 A sample of the equipment has 2006 95 EC Standard used for showi Sal requirements of the directive Standards IEC EN 61010 1 2010 a IEC EN 61010 2 101 20 Issued by Date s Cerpass October 16 2013 The referred test report s sh al requirements in the Low Voltage Directive for CE marking her with the manufacturer s own documented production control the is European authorized representative can in his EC Declaration of Conformity verify compliance with the Low Voltage Directive 4 Vincent Tan Engineering Department ATTESTATION OF CONFORMITY CE Product Magnetic Immunoassay Analyzer Date of Issue 2013 10 09
111. ert No 13 1 Each device must be accompanied by the information needed to use it EN61010 1 2010 TW 14 10079 safely and properly taking account of the training and knowledge of EN61010 2 101 2002 Description Appli cable or not the potential users and to identify the 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 IIa if they can be used safely without any such instructions Where appropriate this information should take the form of symbols 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
112. es the responsibilities and authorities 3 References 3 1 Corrective and Preventive Action procedure MQ QP23 3 2 Post Marketing Surveillance procedure MQ QP25 3 3 Recall procedure MQ QP25 3 4 Customer Complaint form MQ QP24 01 3 5 Incident Report form MQ QP23 01 3 6 Field Safety Corrective Action Report form MQ QP24 01 3 7 ISO 13485 2003 Paragraphs 8 5 2 and 8 5 3 3 8 Medical Device Vigilance System MEDDEV 2 12 1 rev 5 2007 4 Definitions 4 1 Intended purpose The use for which the device is intended according to the data supplied by the manufacturer on the labeling in the instructions and or in promotional materials 4 23 Complaint Any written or oral expression of dissatisfaction with a product related to its identity durability reliability safety effectiveness or performance 4 3 Malfunction The failure of the device to meet any of its performance specifications or otherwise to perform as intended Performed specifications include all claims made in the instructions for use of the device 4 4 Investigation A comprehensive survey of the design and related documentations executed when there is a doubt about the performance of the device 4 5 Harm Physical injury or damage to the health of people or damage to property or the environment 4 6 Incident Any malfunction or deterioration in the characteristics and or performance of a device as well as any inadequacy in the labeling o
113. esignated for the product and approved in the country where the product is used 2 Correct connection amp disconnection Before lunching computer please confirm whether the power is switching on Switch off the power after shutting down the computer 3 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 confirm whether the product is grounded correctly before connecting the input and output terminal of the product 4 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 5 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 6 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 7 Please do not operate when doubting there is a fault If you doubt the product 1s damaged please allow qualified maintenance personnel to check it 8 Prevent circuit exposed Please do not touch any exposed connector and compone
114. f the range of environmental conditions see 1 4 e Degree of protection IEC 60529 IP20 D ifi i if impact rating less than 5 J 5J is tested IK code in accordance to IEC 62262 marked or No IK code is marked symbol 14 of table 1 marked with OO N A N A N A lt 11303269 762 gt Page 9 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark RATED energy level and test method stated 5 4 3 Equipment transportation installation and assembly instructions IEC 61010 2 101 Documentation for the RESPONSIBLE BODY shall include the following as applicable IEC 61010 2 101 Verdict N A a instructions for transportation after delivery to the RESPONSIBLE BODY IEC 61010 2 101 b floor loading requirements IEC 61010 2 101 Table top N A C individual weights of principal heavy subassemblies Light equipment N A IEC 61010 2 101 d location and mounting instructions including the space required for ventilation and for safe and efficient OPERATOR maintenance IEC 61010 2 101 e assembly instructions IEC 61010 2 101 Stated in the manual f instructions for protective earthing IEC 61010 2 101 g the sound data required by 12 5 1 IEC 61010 2 101 N A h instructions relating to the handling containment and exhaust of hazardous substances including any requirements for preventing back syphonage IEC 61010 2 101 i any drainage systems req
115. fied in Table 13 assured in NORMAL and in SINGLE FAULT CONDITION Access normally prevented NI N CO Co On On NO lt T1303269 762 gt Page 27 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict Maximum gap as specified in Table 14 assured in Gap is less than 4mm NORMAL and in SINGLE FAULT CONDITION 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 automatic means or warning marking requires the application of means No means provided for N A ensuring of the stability Compliance checked by following tests as applicable 10 tilt test for other than handheld equipment 7 b multi directional force test for equipment exceeds No the specified equipment N A height of 1 m and mass of 25 kg c downward force test for floor standing equipment Same as above N A d overload test with 4 times maximum load for castor Same as above N A or support that supports greatest load s e castor or support that supports greatest load Same as above N A removed from equipment Provisions for lifting and carrying No such parts N A NI ON O o o oO C o D N A Handles or grips No handle or grips N A Equipment more than 18 kg lt 18kg Has means for lifting or carrying or Handles or g
116. file m data BATF program Qkr ur Bs u ib an S xacPro E 2013 9 4 F 03 16 WINNE D xacPro 2013 9 2 F 04 50 Za a A Bie 4 w RAAN TRUM AN Files 9 3 Prepared the samples before measurement and put them in the thermostatic box side to the sensor coil After few minutes put the sample in the sensor coil and click OK to start the measurement MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 21 Section IV Reagent Preparation Method 1 Take the magnetic reagent and the sample to be detected out of frig and shake them with Vortex for about 15 seconds separately Add 40 ul magnetic reagent and 60 ul sample to be detected into a detector tube commonly Shake the glass tube with Vortex for about 15 seconds to mix the magnetic reagent with the sample to be detected Place the detector tube into the thermostatic bath of XacPro E301 to measure the AC magnetic permeability X ac section V Magnetic Reduction Signal Analysis Mag ag amp e cdi 1 Open the notepad file saved with data process software and plot Calculate the mean values for relevant points before and after the reaction and adopt them in the following formula IMR 976 Yac o Xac 9 X3c o X 100 in wh
117. gement in final installed conditions 8 3 Test Severity Levels Contact Discharge Air Discharge Test Voltage KV of Test Voltage KV of Level Contact discharge Air Discharge 6 8 Specified Remark X is an open level 8 4 Measurement Equipment Instrument Model No Calibration Date Valid Date ESD SIMULATOR Schaffner NSG438 2013 03 29 2014 03 28 Cerpass Technology Corp Tel 886 2 2655 8100 Fax 886 2 2655 8200 Issued Date Oct 09 2013 Page No 30 of 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 8 5 Test Result and Data Final Test Result PASS Pass performance criteria A Required performance criteria B Basic Standard IEC 61000 4 2 Product Standard EN 61326 1 Test Voltage 4 8 KV for air discharge 2 4 KV for contact discharge Temperature 27 C Relative Humidity 50 Atmospheric Pressure 1011 hPa Test Date Oct 4 2013 Contact Discharge Air Discharge 25 times each 10 times each Voltage 2 KV 4 KV 2 KV 4 KV 8 KV Point Polarity FS HCP A A A A VCP A A A A Case T A A A A A A Screw A A A A m ne a e e us Power Port A A A A A A USB Port A A A A A A Console Port A A A A ae eie ae a ues Button Port e A A A A A A Panel Port B B B B B B N
118. gical aspects Emm p LI accessories other devices 59 sharp pointed sharp pointed D6 Hazards related to the user T interface v Available t O Not available 6 1 confusing or missing instructions for use 2 pompier or confusing contol system or confusing control system 6 3 slips lapsand mistakes laps and mistakes e displayed information to actual state 6 5 controversial modes or mapping as compared to existing equipment ambiguous or unclear presentation of L settings measurements or other information 6 7 misrepresentation of results v insufficient visibility audibility or tactility v incompatibility with consumables accessories other medical v devices metrological aspects D7 Hazard arising from functional failure maintenance and aging M Available o Not available Available 7 1 Inadequacy of performance characteristics for the intended use 7 2 Lack of or inadequate specification for maintenance including inadequate Z specification of post maintenance functional checks 73 Inadequate maintenance NE a NNNM 7 4 Lack of adequate determination of device life time 7 5 Loss of mechanical integrity EUM 7 6 Inadequate packaging VENENUM AN 7 7 re use or improper re use Functional Failure 1 5 Measures to Eliminate The Risk amp Its Improvement 1 5 1 Failure Mode and Effect Analysis FMEA Potential Effects of Hazard hazards
119. gned in a careful and considerate way All its materials and manufacturing process are certificated and qualified in international regulations Moreover the tests including safety and Performance of Magnetic Immunoassay Analyzer XacPro E has been tested and compliance with guidance and international standards The Magnetic Immunoassay Analyzer XacPro E packed with well package and label in a international and easy to understanding way In addition MagQu Co Ltd provides a rationale vigilance system for post market product to follow up In summary the material properties processing physical design and product package of Magnetic Immunoassay Analyzer XacPro E are well planned to assure the best safety concerns and intend use Chapter 12 Declaration of Conformity 12 1 EC declaration of conformity Declaration of Conformity The following Type of product Magnetic Immunoassay Analyzer Type Designation XacPro E301 is herewith confirmed to comply with the requirements 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 IEC EN 61010 1 2010 and T1303269 762 IEC EN 61010 2 101 2002 EN 61326 1 2013 EN 61326 2 1 2013 TEEX1309269 EN 55011
120. gqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Prevent circuit exposed Please do not touch any exposed connector and component when the current 1s 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 Warnings indicate the operation conditions that may cause injury or death Cautions suggest conditions or operations that may cause damage to the product or other objects MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 3 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Environmental Considerations The section provides information relevant to the impact of the product on the environment 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 prod
121. h all parameters set at maximum setting Sample is operated with all 67 7 Sample is operated with all parameters set at maximum setting 68 8 Sample is operated with all parameters set at maximum setting Note Measurements are only required for marked ratings Supplementary information lt T1303269 762 Page 43 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 TABLE Durability of markings Form A 4 4 Film coated plastic foil control panel 5 Imprinted on plastic moulded in es IMEMMMZMEEHH IA NOTE Where applicable include print method label material ink or paint type fixing method adhesive and surface to which marking is fixed Marking location Marking method see above Identification 5 1 2 caton o o res 51 4 1 5 2 Field wiring Terminal boxes 5 1 8 Baty charging 1922 NA yo es ee o Yda vedea vedot NENNEN _ DL 1 1 1 2 2 N A N A 2 N A mm Supplementary information lt T1303269 762 Page 44 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark e TABLE Protection against electric shock Block diagram of systemForm A 5 ELEM Pollution degree Location or Insulation Maximum CREEPAGE Distance CLEARANCE Test Comments type working NOTE 3 Um 3 voltage description NOTE 1 voltage ibid CTI Other CTI laud 2 NOTE 2 mm Primary to 240Vac 1 5 3 0 t Pass accessible parts Primary to 240Vac 3 0 l 3000
122. hazards related to the use of the device 32 Not Acceptable 2 1 Electricity Leakage current may cause operator getting shock 16 ALARP Surrounding temperature may influence measuring result The product will generate magnetic field and the magnetic fields surround may influence measuring result 2 4 Magnetic fields 4 1 Electromagnetic interference Electromagnetic will influence measuring result 4 2 Electromagnetic wave may be 4 Electromagnetic restrain restrain by shielding Acceptable si Inadequat hut 16 Inadequate supply of oe sd ds 4 4 ower down the equipment ALARP Other devices which work by electromagnetic force may influence measuring result and may be influenced by electromagnetic restraining 4 7 Incompatibility with other devices 2 Inadequate labeling Inadequate warnings 2 2 8 Acceptable 8 Acceptable 4 Acceptable 4 Acceptable Current Design Controls ae Every single part of product which transports power should be accessed by safety guild 8 2 4 Acceptable 8 4 2 Build a temperature controlling system to restrict temperature changes Build a shielding Build a shielding Set equipment out of other equipments which work by electromagnetic force Every single part of product g which transports power should be 2 accessed by safety guild Acceptable Set equipment out of other equipments which work by electromagnetic force Write s
123. he 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 1 3 1 Probability of Failures Definition Probability Rating Continues to occur lt 1 2 10 High occurs lt 1 20 8 Occasionally occur lt 1 200 6 Low occurs lt 1 2000 4 Hardly occurs lt 1 20000 2 Does not occur 0 l 1 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 p No risk No damage I 1 3 3 Risk Priority Number RPN 1 3 3 1 RPN Probability Severity Risk Priority Number methodology is a technique for analyzing the risk associated with potential problems identified during a Failure Mode and Effects Analysis FMEA Red Non acceptable Green ALARP White Acceptable 1 3 3 2 Rating scales means the risk level defined as following listed 10 8 2 6 E 9 4 A 2 1 1 2 4 6 8 10 Severity 1 4 Assessment Result General principle Identification of possible hazards and contributing factors associated with medical device refer to ISO 14971 D2 Energy hazards M Available o Not available 2i jemky 0000 o v o 2 2 Heat 0 0 0 00 00 00 Y 23 Mechanical force o v 24 Magnetic fields Y o 25 lonizi
124. health Appli cable or not 15 Standard Sub clause s 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 The device is not intend to monitor patients Clause 12 5 12 6 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 Standard Sub clause s cable 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 16 Report Document Comments ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validation report No RD02 _ Product Master file No MFO02 Risk Management Report No RM02 02 Product research files XacPro E ISO 13485 Quality System Cert No TW 14 10079
125. ich Xac o 1s the ac magnetic susceptibility signal before the reaction and Xac p is the ac magnetic susceptibility signal after the reaction SF BONG tensed aneAbenrRPR sd Rea Pii NAW ipsa 283 TRIMA 22 Webs dgsin wwuWwaagg 498b Emaihtardnto omacdugines nick 88662 8664955567 FRG xt 88662 286667 P909 Chapter V Debugging and Maintenance Common error information and simple troubleshooting are shown as following 1 The X signal shows in the status of error out diagram shown as below refers to the program fails to seize signal from the instrument Please restart PC and the program after confirming the connection 1s in good condition error out A r2 Tro open specified r mM a pez nem 4 2 Frequent Cease and Save and Stop warming will lead to a fault of the instrument It is recommended sending the instrument back to our company for repair every season if you use the two commands above frequently 3 If it is impossible to achieve balanced for the temperature control system with specified usage pattern please send the instrument back to our company for repair 4 If the lights at the back of temperature box are not bright after start please send the instrument back to our company for repair 5 If the program is damaged or unable to start please reinstall it If there is any other fault please reinstall or repair the Window system in PC If there 1s still any problem unsolved
126. ighest Steady State level 1 72 Lowest Steady State level 1 72 max d c between adjacent 0 00 Pass max d c between any 0 00 Flicker Long term Flicker indicator Plt 0 00 Short term Plicker indicator Pst Plt Interval Pst l 0 02 2 0 02 i 0 02 4 0 02 E 0 02 6 0 02 7 0 02 a 0 02 9 0 02 10 0 02 11 0 02 12 0 02 Pst classifier Duration Flicker 0 1 0 01 0 7 0 00 1 0 0 00 1 5 0 00 2 2 0 00 34 0 00 4t 0 00 6 0 00 8t 0 00 10 0 00 13 0 00 17 0 00 30 0 00 50 0 00 80 0 00 ley Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 26 of 50 a CERPASS TECHNOLOGY CORP Report No TEEX1303269 C C Final Test Result PASS Basic Standard EN 61000 3 3 Temperature 25 C Test Data Oct 03 2013 Relative Humidity 58 Temperature Box Supply Voltage 233 9 to 234 1 Vrms 330 3 Vpk Frequency 50 00 Hz THD 0 7 Crest Factor 1 411 peak at 93 7 deg Load Power 0 016 to 0 078 kW 0 142 KVA Power Factor 0 547 Load Current 0 23 to 0 61 Arms 1 91 Apk Crest Factor 2 744 Voltage Variations Highest Half cycle level 1 86 Lowest Half cycle level 1 64 di max 0 22 Pass Number of Change Intervals 1 Highest d t for 500 me 0 00 Pass Longest d t over 3 30 0 00 seconds Steady State definition 1000 ms below 0 32 Highest Steady State level 1 80 Lowest Steady State level 1 80 max dic bet
127. impedance of plug connected equipment Form A 10 oP Voltage attained Calculated resistance after 1 min Maximum 0 1 or 0 2 Q V NOTE 2 Q NOTE 1 NOTE 1 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 6525 TABLE Bonding impedance of permanently connected equipment N A Test Voltage attained after 1 min Verdict ACCESSIBLE part under test current maximum 10 V A V Supplementary information 6526 TABLE Transformer PROTECIVE BONDING screen Form A 11 N A Test current Voltage attained Calculated resistance Verdict ACCESSIBLE part under test see is after 1 min maximum 0 1 maximum 10 V Q V 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 1303269 762 Page 49 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict TABLE protective impedance Form A 12 N A A single component Component Location Calculated Verdict Comments Working Current Power Working voltage M d vc dissipation V A combination of components Location Comments Component NOTE A PROTECTIVE IMPEDANCE Shall not be a single electronic device that employs electron conduction in a vacuum gas or semiconductor Su
128. ittee No 201105996RC 2 Specimen Collection and Preparation e Collect all blood samples by wearing protective equipment and following universal precautions for venipuncture 5 ml of whole blood is collected in an anticoagulant free serum separation tube BD Vacutainer SST II Advance e Each sample 5 ml is equally divided into two groups for both study and reference assay e Ensure that complete clot formation has taken place prior to centrifugation e Centrifuge the serum separation tube for 10 minutes at 1 500 2 000x g to separate the serum from the red blood cells e After centrifugation serum is taken by pippetman and equally divided into four 1 5 ml microcentrifuge tubes 1 ml each Serum samples are labeled and deep frozen 20 C or colder until needed Avoid repeated freezing or thawing 3 IMR Assays of serum CEA protein for diagnose of colorectal cancer The CEA concentrations in human serum samples were determined by using the IMR CEA reagent 24 serum samples from healthy subjects Normal control and 30 serum samples from patients with colorectal cancer CRC were used for the CEA assay using the IMR method CRC patients were identified using either pathological evidence or an immunoassay The detected CEA concentrations 9CEA IMR of these serum samples are plotted in Figure X a The 9CEA IMR values for the normal control group are distributed over a relatively lower range than those for CRC patients Most of 90CEA IM
129. l apply at the edge between two frequency bands 2 Distance refers to the distance in meters between the measuring instrument antenna and the closed point of any part of the device or system oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 17 0f 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 5 2 Test Procedures a The EUT was placed on a rotatable table top 0 8 meter above ground b The EUT was set 10 meters from the interference receiving antenna which was mounted on the top of a variable height antenna tower c The table was rotated 360 degrees to determine the position of the highest radiation d The antenna is a half wave dipole and its height is varied between one meter and four meters above ground to find the maximum value of the field strength both horizontal polarization and vertical polarization of the antenna are set to make the measurement e For each suspected emission the EUT was arranged to its worst case and then tune the antenna tower from 1 M to 4 M and turn table from 0 degree to 360 degrees to find the maximum reading f Set the test receiver system to Peak Detect Function and specified bandwidth with Maximum Hold Mode g If the emission level of the EUT in peak mode was 3 dB lower than the limit specified then testing will be stopped and peak values of EUT will be reported otherwise the emissions which do not have 3 dB margin wil
130. l be repeated one by one using the quasi peak method and reported 5 3 Typical Test Setup Antenna EN Equipment under Test a 10M ed 0 8M Turn Table Ground Plane Receiver 5 4 Measurement Equipment Instrument Manufacturer Model No Serial No Calibration Date Valid Date Amplifier Agilent 8447D 2944A10531 2012 10 17 2013 10 16 Bilog Antenna Schaffner CBL6112B 2840 2013 03 27 2014 03 26 EMI Receiver R amp S ESCI 100821 2013 01 15 2014 01 14 ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 18 of 50 se CERPASS TECHNOLOGY CORP Report No TEEX1303269 5 5 Test Result and Data AC 230V 50Hz Pol Phase VERTICAL Jest Wiod Dectection Box Temperature Box Temperature 06 C Working Test Date Oct 01 2013 Humidity 172 ressure 30 0 dBu m Class A 10m Radiation Margin 6 dB 40 n 1 p 0 0 30 000 57 50 85 00 112 50 140 00 167 50 195 00 222 50 250 00 305 00 MHz Frequency Factor Reading Level Limit Margin MHz dB m dBuV dBuV m dBuV m dB Note Level Reading Factor Margin Level Limit il Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 19 of 50 CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase VERTICAL Test iiode Dectection Box Temperature Box Te
131. luation Clinical Data 4 2 2 1 Subjects 24 serum samples from healthy subjects Normal control and 30 serum samples from patients with colorectal cancer CRC were used for the IMR CEA assay The CEA concentrations in human serum samples will be determined using the IMR signals CRC patients were identified using either pathological evidence or an immunoassay All of the enrolled patients provided informed consent before undergoing the procedure and this study was approved by National Taiwan University Hospital Research Ethics Committee No 201105996RC 4 2 2 2 Specimen Collection and Preparation e Collect all blood samples by wearing protective equipment and following universal precautions for venipuncture 5 ml of whole blood is collected in an anticoagulant free serum separation tube BD Vacutainer SST II Advance e Each sample 5 ml is equally divided into two groups for both study and reference assay e Ensure that complete clot formation has taken place prior to centrifugation e Centrifuge the serum separation tube for 10 minutes at 1 500 2 000x g to separate the serum from the red blood cells e After centrifugation serum is taken by pippetman and equally divided into four 1 5 ml microcentrifuge tubes 1 ml each Serum samples are labeled and deep frozen 20 C or colder until needed Avoid repeated freezing or thawing 4 2 2 3 IMR Assays of serum CEA protein for diagnose of colorectal cancer The CEA concentrations in huma
132. manaussceateusnremismecmamncsaanmtnenidrndnsoalia 33 9 4 Test Result and RETINET m Emm 34 95 est PHOIDOFADBS see ig hea os Sane EE EE e EEE E EEEE 35 ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 20f50 uU CERPASS TECHNOLOGY CORP Report No TEEX1303269 10 Electrical Fast Transient Burst Immunity Test ccccsssseeeeeseeeeeesseeseenseeeeeeseeeeeeaseeseenseeseenseeesoeaseeses 36 0x MEE duele i e ER 36 10 2 Test ucdsdd u 36 10 3 Measurement EQuipment cccccccccccsssececsseeeecseeceeeeeseeeesaeeeeseaseeessaseeessaeeeeseseeeseeeeesseneessnaeeees 36 TOs Tes Reut BI 37 10 5 NESE PROON 6 sagencnesasratentmncanaecanenaitaatucanmenanaaines bends nauaanedrauesixtesusantoosbendinidnnaandvapeenhtaninatanateadinnsns 38 JEUDI nare A A 39 PEE LOCC ONG aes ETT t 39 11 2 Test Severity Level 39 11 3 Measurement EqQuipment cccccccsssccccesseeccsesseecseseeeseaeeecseuseeeseasecessageeessauecessegeeeessaneeessageees 40 11 4 Test Result and DAA sessenuuudurcuit truth ue nt Ra rxkewaa in unckas kt na dinem aa gura uaciuvR Ex md dt rm aua opu aid randi 40 11 5 Test Photographs ssssssssssssssssseseeeeen eene nennen nennen nnn nna nnne snae nns nn nnns sna nnn rsen nnns 41 12 Conduction Disturbances induced by Radio Frequency Fields
133. meets the requirements for basic insulation Bridging the insulation does not cause ignition see Form A 2 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 CO Containment of the fire within the equipment should it The equipment meets one of 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 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 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 perortedas spected n Tae tsr m meta sccenwinamestior M tales as speciesinFgwe oo 2 Material of ENCLOSURE and any baffle or flame barrier is made of Metal except magnesium or Plastic encased N A N A N A N A N A lt T1303269 762 gt Page 31 of 66 OQ
134. mperature 06 C Working l 72 Test Date Oct 01 2013 Humidity 07298 ressure 0 0 dBu m Class A 10m Radiation Margin 6 dB A 40 2 5 u 300 000 370 00 440 00 510 00 560 00 650 00 720 00 790 00 460 00 1000 00 MHz Frequency Factor Reading Level Limit Margin Detector Height Azimuth MHZ d B m dBuV dBuV m dBuV m dB cm 319 6000 36 43 2696 47 00 20 04 Ls e s 5065000 475 25 15 2040 7 00 660 ae 100 o ear 2000 24 2837 2501 7 00 2109 ap 100 0 F Note Level Reading Factor Margin Level Limit oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 20 of 50 se CERPASS TECHNOLOGY CORP Report No TEEX1303269 AC 230V 50Hz Pol Phase HORIZONTAL Test Mode Dectection Box4 Temperature Box Temperature 06 C Working Test Date Oct 01 2013 Humidity 72 96 ressure 30 0 dBu m Class A 10m Radiation 40 1 2 3 4 0 0 30 000 57 50 85 00 112 50 140 00 167 50 195 00 222 50 250 00 305 00 MHz Frequency Factor Reading Level Limit Margin Detector eight Azimuth pe MHz dB m dBuV dBuV m i dBuV m dB cm 2 3 1691500 3530 30 7 2447 40 00 5ss ae 4o o F L782250 3558 2666 2313 40 00 6s7 ae 40 0 F 1152500 2375 3753 2378 4000 1622 ae o 9 P EE EZ La 221 1250 3500 3
135. mponents used as transient overvoltage No such parts limiting devices Test conducted between each pair of MAINS SUPPLY see Form A 30 TERMINALS N A N A N A No HAZARD resulting from rupture or overheating of the component N A N A N A N A N A no bridging of safety relevant insulation N A N A N A N A N A N A N A N A OOO no heat to other pants above te setignitonpoins s PROTECTION BYINTERLOGKS J before OPERATOR exposed LM Single fault unlikely to occur or Cannot cause a HAZARD NA HAZARDS RESULTING FROM APPLICATION i wi Rewowacvroneseenmzwese O No HAZARDS arising from settings not intended and not EE described in the instructions Other cases of REASONABLY FORESEEABLE MISUSE addressed by RISK assessment 16 Ergonomic aspects lt T1303269 762 gt Page 39 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Result Remark Requirement Test Factors giving rise to a HAZARD the RISK assessment is reflecting those aspects a limitation of body dimensions Not a big equipment displays and indicators Readily to read accessibility and conventions of controls Readily to access arrangement of TERMINALS s RISK assessment No hazards other than addressed in Cl 6 to 16 RISK assessment conducted if HAZARD might arise and not covered by Clauses 6 to 16 TOLERABLE RISK achieved by iterative documented process covering the following a RISK analysis
136. n 2008 There are many milestones since 2008 as listed in the following table May Certificated wit ISO13485 2003 and Certificated wit 18013485 2003 and IS09001 2008 2008 Certificated with Medical device Good Manufacture October Practicing GMP 2009 Award with the 16 Taiwan Small amp Medium Enterprises November Innovation Award issued by Ministry of Economic Affairs Taiwan 2010 Award with the 8 Taiwan Gold Root Award Sign up distribution agreements in Japan and China Award with Taiwan Healthcare and Agriculture Biotech September l l 2011 Industries Innovation and Excellent Awards Issue the first IMR assay kit for aquatic disease Grouper December viruses Mach S up distribution agreements for bio functionalized rg l l l l magnetic nanoparticles in Taiwan and Japan Initiate the development and clinic trial for assaying blood 2012 September CEA with the financial support by Ministry of Economics Taiwan Move to self owned office factory in New Taipei City Award with Excellence in Agriculture Technology Award by O Council of Agriculture Taiwan 1 Issue magnetic micro beads Qbeads for purifications of anuar d antibodies proteins pathogens and nuclei acids 2013 Award with Excellence of Industrial Nanotechnology Award September by Taiwan Nanotechnology Industry Development Association Invested by venture capital companies in Taiwan US 5M Certificated with 18013485 20
137. n V Signal Output Module Micro control Section VI Thermoelectric Cooler TE Cooler Chapter IV Operation Procedure Section I Operating Procedure for Installation Section II Setting amp Start up Procedure of XacPro E301 Section III y Measurement Procedure Section IV Reagent Preparation Method Section V Magnetic Reduction Signal Analysis Chapter V Debugging and Maintenance Chapter VI Attentions Section I Cleaning amp Maintenance Section II After sale Service amp Guarantees Appendix A Structural Block of XacPro E301 B Dimensional Drawing of Power Converter C Specifications of XacPro E301 D List of Packing Inserts E Warning Icon Description MagQu Co Ltd 12 12 18 20 23 23 25 26 26 26 28 29 30 31 32 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Safety Instructions Please review following safety warnings to avoid personal injuries and damages to the product and any related product In order to avoid potential risk please use the product in compliance with relevant instructions Only qualified maintenance personnel can conduct maintenance procedure 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 Correct Connection amp Disconnec
138. n 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 Appli Standard Sub clause s cable or not 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 Description Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate validated method 8 5 Devices intended to be sterilized must be manufactured in appropriately controlled e g environmental conditions 7 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 8 The packaging and or label of the device must dis
139. n report No RD02 Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 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 handle 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 cable or not 18 Standard Sub clause s 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 Report Document Comments ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validation report No RD02 Risk Management Report No RM02 02 Product research files XacPro E ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validation report No RD02 Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 Clause Description Appli Standard Sub clause s Report Document Comments cable or not 12 8 Protection against the risks posed to the patient by energy supplies or No The devic
140. n serum samples were determined by using the IMR CEA reagent 24 serum samples from healthy subjects Normal control and 30 serum samples from patients with colorectal cancer CRC were used for the CEA assay using the IMR method CRC patients were identified using either pathological evidence or an immunoassay The detected CEA concentrations 9CEA IMR of these serum samples are plotted in Figure X a The 9CEA IMR values for the normal control group are distributed over a relatively lower range than those for CRC patients Most of 90CEA IMR values for the normal control group are within the range 0 6 ng ml to 1 5 ng ml but the 9CEA IMR values for CRC patients range from 6 0 ng ml to 20 ng ml An analysis of the receiver operating characteristic ROC curve shown in Figure X b shows that the threshold for the diagnosis of CRC by an assay of CEA in serum using the IMR method is 4 05 ng ml which results in the clinic sensitivity of 0 90 and a specificity of 0 87 e Normal control CRC 0 1 1 0 10 0 z f Li 0 2 0 4 w dceaime ng ml 1 specificity Fig X a Measured CEA concentration cgA pug using IMR CEA reagent and analyzer for normal subjects normal control and patients with colorectal cancer CRC b The ROC curve for the analysis of the clinical sensitivity and the specificity for the diagnosis of colorectal cancer using the detected CEA concentration 9CEA IMR in serum Reference Che Chuan Yang Shieh Yueh
141. n the first paragraph the notified body shall having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency EMEA acting particularly through its committee in accordance with Regulation EC No 726 2004 1 on the quality and safety of the substance including the clinical benefit risk profile of the incorporation of the substance into the device When issuing its opinion the competent authority 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 determined by the notified body Where a device incorporates as an integral part a human blood derivative the notified body shall having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device seek a scientific opinion from 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 When issuing its opinion 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 determined by the
142. necting device see 6 12 IEC 61010 2 101 c instructions for interconnections to accessories and other equipment including details of suitable accessories detachable parts and any special materials IEC 61010 2 101 d limits for intermittent operation IEC 61010 2 101 Continuous operation e an explanation of symbols used on the equipment and where HAZARDS are involved the reason for using a symbol in each particular case IEC 61010 2 101 f instructions for any actions to be taken by an Trouble shooting is provided OPERATOR in case of a malfunction IEC 61010 2 in the manual 101 g instructions and recommendations for cleaning and Stated in the manual decontamination with materials recommended see 11 2 IEC 61010 2 101 h instructions for the disposal of waste IEC 61010 2 101 i if NORMAL USE involves the handling of hazardous Stated in the manual substances instructions on correct use and any need for training or personal protection measures IEC 61010 2 101 j if there could be contact with the skin when handling potentially infectious substances such as human samples or reagents the need to use protective gloves or other protective means IEC 61010 2 101 k if the equipment could emit hazardous aerosol No vapour vapours in NORMAL USE instructions for protection of the mouth nose or eyes IEC 61010 2 101 I if potentially hazardous visible or invisible radiation No radiation
143. nents and Components used in subassemblies meet relevant requirements accordance with their specified ratings N A N A N A N A N A N A N A N A N A N A N A Motor temperatures Does not present a HAZARD when stopped or prevented see Form A 21 from starting or Protected by over temperature or thermal protection No such parts device conform with 14 3 Series excitation motors Connected direct to device if over speeding causes a N A 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 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 lt T1303269 762 gt Page 38 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark MAINS voltage selecting devices No such parts ONA 4 8 Accidental change not possible BEEN MAINS transformers tested outside equipment MEE Printed circuit boards rT Data shows conformity with V 1 of IEC 60695 11 10 Printed circuit boards of or better or material with a flammability classification of FV O min of IEC60707 or UL94 Test shows conformity with V 1 of IEC 60695 11 10 or see Form A 18 better Not applicable for printed wiring boards with limited energy circuits 9 4 1 Circuits or co
144. ngradiation v 2 6 Non ionizingradiation v 2 10 Patient support device failure v 211 Pressure 0 r 2 12 Acoustic pressure oo ooo v o 213 Vibration o S D3 Biological hazards 4 Available o Not available Available SIS 32 Bio incompatibility I3 33 Incorrect formulation 1 Y 34 Toxicity 3 5 Allergenicity Y 3 6 Mutagenicity 00 0 Yo 37 Carcinogenicity 000 Y 3 8 Teratogenicity 0 0 Y i 39 Pyrogenicity 0 Y 3 10 cross infecion 0 Y 31l Biobuden 0 v ES NR NC NN Mu E Degradation D4 Environmental hazards M Available o Not available 41 Electromagnetic interference YT 42 Electromagnetic restrain Y 43 Electromagneticshoot o Y 44 Inadequate supply of power Y 45 Inadequate supply of coolant mamme v EROR conditions 4 7 Incompatibility with otherdevices MT 48 Accidental mechanicaldamage J p and or device disposal D5 Hazards related to the use of the device M Available o Not available 5 1 Inadequate labeling Y 5 2 Inadequate operating instructions Y 5 3 Use by unskilled untrained personnel Y cra eo foreseeable misuse aa Insufficient warning of side effects Pe a ae bil eer warning of hazards likely with PT re use of single use devices Ee rl metrolo
145. nt Test Result Remark 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 Test Leakage pressure Comments Mpa Yes No Supplementary information 12 21 TABLE lonizing radiation Form A 26 12 2 1 2 Equipment intended to emit radiation dE Measured values Verdict Locations tested uSv h Comments Supplementary information 12 2 1 3 Equipment not intended to emit radiation Max allowed effective dose rate at 100 mm me Measured values Verdict Locations tested uSv h Comments Supplementary information lt T1303269 762 Page 59 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 142 51 TABLE Sound level Form A 27 Locations tested Measured values Calculated maximum sound dBA pressure level At operator s normal position and at bystanders positions b c Supplementary information 12 5 2 Ultrasonic pressure NENNEN Comments N NOTE No limit is specified at present but a limit of 110 dB above the reference pressure value of 20 uPa is under consideration for applicable frequencies between 20 kHz and 100 kHz Supplementary information lt T1303269 762 Page 60 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101
146. nt groups and if applicable on appropriate precautionary measures Devices must be designed and manufactured in such a way as to Directive 98 79 EC ISO 13485 Quality reduce as much as possible risks posed by the unintentional ingress ENISO13485 2012 System Cert No of substances into the device taking into account the device and the ENISO14971 2012 TW 14 10079 nature of the environment in which it is intended to be used EN61010 1 2010 EN61010 2 101 2002 _ Product Master file No MFO02 Risk Management Report No RM0O2 02 Clause Description 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 eliminatio
147. nt when the current is conveyed 9 Please do not operate under a moist condition 10 Please do not operate in the flammable and combustible air 11 Please keep the product surface clean and dry 12 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 13 Disposal of product discarded Please refer to following instructions when recycling any instrument or component 14 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 1 2 7 Intended use of Device The Magnetic Immunoassay Analyzer XacPro E designed by MagQu Co Ltd 1s 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 E can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility which is so called immunomagentic reduction 1 2 8 Classification Thi
148. ntended purpose of the device The limits of accuracy must be indicated by the manufacturer Appli cable or not 11 Standard Sub clause s Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 EN61010 1 2010 EN61010 2 101 2002 EN15223 1 2012 Directive 98 79 EC ENISO13485 2012 Report Document ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 _Risk Management Report No RM02 02 ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 _Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 Comments Clause Description Appli Standard Sub clause s Report Document Comments cable or not The measurement monitoring and display scale must be designed in YES Directive 98 79 EC ISO 13485 Quality line with ergonomic principles taking account of the intended purpose ENISO13485 2012 System Cert No of the device TW 14 10079 _Design Verification and Validation report No RD02 _ Product Master file No MFO02 Product user Manual XacPro E ver 201309 be expressed in legal units conforming to the provisions of Council Directive 80 181 EEC Protection against radiation The device is a low voltage device and never generates high energy 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 pos
149. o the Symbol 101 is marked samples or reagents used shall be prominently marked with symbol 101 of Table 1 IEC 61010 2 101 Equipment that can be hazardous due to the use of oymbol 14 is marked chemical substances shall be marked with the appropriate symbol or if none is available symbol 14 of Table 1 IEC 61010 2 101 Containers or bags for biohazardous waste material oymbol 101 is marked which can be removed from the equipment during NORMAL USE shall be marked with symbol 101 of Table 1 IEC 61010 2 101 Other warning markings are specified in 5 1 5 1 c Provided 6 1 2 b 6 5 1 2 g 6 6 2 7 2 C 7 3 10 1 13 2 2 IEC 61010 2 101 5 9 Durability of markings IEC 61010 2 101 Durability of markings the required markings remain see Form A 4 clear and legible NORMAL USE IEC 61010 2 101 Documentation 4 General Accompanied by documentation for safety purposes Equipment is accompanied by documentation for safety purposes for OPERATOR or RESPONSIBLE BODY IEC 61010 2 101 Safety documentation for service personnel authorized by the manufacturer Documentation necessary for safe operation is In printed media provided in printed media or in electronic media if available at any time oF N A OI O1 A A lt T1303269 762 gt Page 8 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Documentation includes i a intended use The user s manual p
150. o the external PC by USB so a USB signal output converter USB 2 0 1s fitted between MCU and the external PC Section VI Thermoelectric Cooler TE Cooler XacPro E301 uses a cooling chip to control temperature in the test box the thermoelectric cooler TE Cooler will conduct cooling process automatically when the temperature is higher than the set value and TE Cooler will conduct heating process automatically when the temperature 1s lower than the set value The control circuit of TE Cooler is fitted in the temperature control box MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Chapter IV Operation Procedure 1 Driver used with the operating software is provided by Adlink Technology and National Instruments without amendments by our company and can be requested from the former two companies directly 2 It is required to calibrate XacPro E301 with the standard solution produced by our company every three months to ensure accuracy of the instrument 3 The following operational programs are the series product of Windows launched by Microsoft which are used as OS and not applicable for Mac series and Linux System Section I Installation of Software Put the software disk in to cd rom of the computer Then double click Labview driver Click Next XacPro E
151. on your hard drive InstallShield KE ADLINK DAQPilot V2 3 1 1201 InstallShield Wizard Ready to Modify the Program The wizard is ready to begin installation If you want to review or change any of your installation settings click Back Click Cancel to d exit the wizard Current Settings Setup Type Custom Destination Folder C MDLINKIDAGPilotl User Information Name ASUG1 Company InstallShield r jj ADLINK DAQPilot V2 3 1 1201 InstallShield Wizard InstallShield Wizard Completed The InstallShield Wizard has successfully installed ADLINK DACPilot V2 3 1 1201 Click Finish to exit the wizard MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 15 Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 10 After finish installation of DAQ Pilot click Driver installation in step 7 Follow the guild to undergo next installation ji ADLINK USB DASK v1 00 InstallShield Wizard Welcome to the InstallShield Wizard for ADLINK USB DASK v1 00 The InstallShield R Wizard will install ADLINK USB DASK v1 00 on your computer To continue click Next WARNING This program is protected by copyright law and international treaties i ADLINK USB DASK v1 00 InstallShield Wizard Customer Information Please enter yo
152. onal 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 10 Report Document Comments ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 _Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 _Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 Clause 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 i
153. ons to be taken These details should cover in particular k precautions to be taken in the event of changes in the performance I m n 0 p q of the device precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields external electrical influences electrostatic discharge pressure or variations in pressure acceleration thermal ignition sources etc 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 precautions to be taken against any special unusual risks related to the disposal of the device medicinal substances or human blood derivatives incorporated into the device as an integral part in accordance with Section 7 4 degree of accuracy claimed for devices with a measuring function date of issue or the latest revision of the instructions for use 24 Report Document Comments Chapter 3 Risk Management 1 Risk Management The risk management reports are for the product Magnetic Immunoassay Analyzer XacPro E Product name Magnetic Immunoassay Analyzer Product code XacPro E Version 2015 01 In general this risk assessment report for XacPro E made by MagQu Co Ltd was carried out in accordance with the requirements of ISO 14971 2007 in which an explicit risk assessment
154. or special skill Yes C 2 27 How will information for safe use be provided Ans C228 Ans 2 29 Ans C 2 29 Ans Presented in the manual or package insert Will new manufacturing processes need to be established or introduced No Is successful application of the medical device critically dependent on human factors such as the user interface No 1 Can you user interface design features contribute to use error No C 2 29 2 Is the medical device used in an environment where distractions can cause Ans C 2 29 Ans use error Yes 3 Dose the medical device has connecting parts or accessories Yes C 2 29 4 Dose the medical device have a control interface Ans Yes 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 No C 2 29 7 Will the medical device be use by persons with special needs Ans Yes C 2 29 8 Can the user interface be used to initiate user action Ans No 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 1 3 Risk Assessment Methodology Fills in the scoring from 1 10 in t
155. orrectly as a precondition there must be no danger for the patient to justify not reporting Expected and foreseeable side effects which meet all the following criteria Clearly identified in the device labeling e Clinically well known as being foreseeable and having a certain qualitative and quantitative predictability when the device is used and performs as intended e Took in account in the risk assessment Negligible likelihood of occurrence of death or serious deterioration in state of health Note A decision to not report must be justified and documented 5 12 Vigilance reporting authorities 5 12 1 5 12 2 Complaint originating from a member state in the EU 5 12 1 1 The Competent Authority in the relevant state where the incident occurred 5 12 1 2 The Notified Body that certify the device 5 12 1 3 The EU Authorized Representative If the complaint was reported from a non EU member or Switzerland then the report will be based_on the actual law of each country in addition if applicable the following authorities should be notified 12 2 1 The Competent Authority responsible for the EU Authorized Representative 7 5 12 3 5 12 2 2 The EU Authorized Representative 5 12 2 3 The Notified Body that certify the device Note Incidents which occurred outside the EU and do not lead to a FSCA relevant to these geographic areas do not need to be reported The list of vigilance contact points wi
156. orrugated carton if necessary The manual should be also put into the carton All the details about manufacture QC and packing are regulated in MQ WIM 03 MQ WIM 03 01 02 03 04 Quality Management System following ISO 13485 and ISO9001 Chapter 10 Vigilance System Vigilance System 1 General 1 1 This procedure applies to written or oral complaints initiated by a customer sales representative MagQu Co Ltd employee or any other source such as a government agency etc 1 2 Customers complaints are handled according to controlled and defined processes from receiving of the complaint until the end of its processing i e identification of the malfunction problem solution implementation in the field if applicable through reply to the client after investigation is completed 1 3 This procedure describe the system for the notification and evaluation of incidents and field safety corrective actions FSCA in the European Community 1 4 Corrective action includes but may not be limited to a device recall the issue of a field safety notice additional surveillance modification of devices in use modification to future device design components or manufacturing process modification to labeling or instructions for use 2 Purpose 2 1 The purpose of this procedure is to define a clear and effective policy for collecting documenting and handling of customer complaints and vigilance reporting 2 2 This procedure defin
157. ot used as disconnecting N A device If push button used as power supply switch Not 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 8 No field wiring box N A N A N A N A Cable temperature RATING marked Marking visible before and during connection or beside TERMINAL 1 Transport and storage IEC 61010 2 101 Packaging shall be labelled to indicate any special conditions for transport or storage IEC 61010 2 101 5 2 Warning markings Visible when ready for NORMAL USE C1 C1 C ce NO lt I 1303269 762 gt Page 7 of 66 eV IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Are near or on applicable parts Symbols and text correct dimensions and colour a symbols min 2 75 mm and text 1 5 mm high and contrasting in colour with background Verdict 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 Statement to isolate or disconnect the power if access u N A by using a tool to HAZARDOUS LIVE parts is permitted by user Advise how to avoid contact with HAZARDOUS live parts IEC 61010 2 101 Equipment that can be potentially infectious due t
158. ote A normal performance within levels specified by the manufacturer requestor or purchaser Note B temporary loss of function or degradation of performance which ceases after the disturbance ceases and from which the EUT recovers its normal performance without operator intervention Test engineer oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 31 of 50 e o Cc a CERPASS TECHNOLOGY CORP Report No TEEX1303269 8 6 Test Photographs oe Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 32 of 50 o CE C CERPASS TECHNOLOGY CORP Report No TEEX1303269 9 Radio Frequency Electromagnetic Field Immunity Test 9 1 Test Procedure a he equipment to be tested is placed in the center of the enclosure on a wooden table The equipment is then connected to power and signal leads according to pertinent installation instructions b The bilog antenna which is enabling the complete frequency range of 80 1000MHz 1400 2700MHz is placed 3m away from the equipment The required field strength is determined by placing the field strength meter s on top of or directly alongside the equipment under test and monitoring the field strength meter via a remote field strength indicator outside the enclosure while adjusting the continuous wave to the applicable antennae c he test is normally performed with th
159. packaging or instructions for use shall contain in addition the name and address of the authorised representative where the manufacturer 20 Standard Sub clause s 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 2012 EN 15223 1 2012 EN 61010 1 2010 EN 61010 2 101 2002 Comments Report Document _Product Master file No MF02 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 Product user Manual XacPro E ver 201309 ISO 13485 Quality System Cert No TW 14 10079 c f g h 1 J and m are excluded _ Product Master file No MFO02 Product user Manual Clause Description Appli Standard Sub clause s cable or not does not have a registered place of business in the Community b the details strictly necessary for the user to identify the device and c the contents of the packaging where appropriate the word STERILE where appropriate the batch code preceded by the work LOT or the serial number where appropriate an indication of the date by which the device should be used in safety expressed as the year and the month where appropriate an indication that the device 1s for single use A manufacturer s indication of single use must be consistent across the Community if the device 1s custom made the word
160. pe Standard EN 55011 EN 61326 1 and EN 61326 2 1 The complete test system included Notebook Mouse Printer and EUT for EMI test The complete test system included Notebook and EUT for EMS test d The following test modes were performed for conduction and flicker test Test Mode 1 Dectection Box Temperature Box Working Main Dectection Box Test Mode 2 Dectection Box Temperature Box Working Main Temperature Box e The following test mode was performed for radiation and EMS test Test Mode 1 Dectection Box Temperature Box Working f An executive program EMI exe under WIN 7 which generates a complete line of continuously repeating H pattern was used as the test software The program was executed as follows 1 Turn on the power of all equipment 2 The PC reads the test program from the hard disk drive and runs it 3 The PC sends H messages to the monitor and the monitor displays H patterns on the screen 4 The PC sends H messages to the internal Hard Disk and the Hard Disk reads and writes the message 5 Repeat the steps from 2 to 4 g An executive program Xac Pro E under WIN 7 was executed to read and write from EUT O O ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 7 of 50 CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 3 3 Description of Test System EMI Device Model No Notebook Satellite L730 Power Ca
161. ple 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 xac accordingly Hereafter the x4 of pure magnetic reagent is referred as to Yaco as shown in Fig 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 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 Yac 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 the ya of magnetic reagent mixed with a sample is denoted with Y c 4 According to the description above more bi molecules the sample contains more bindings between magnetic beads and bi molecules will occu
162. please contact our company as soon as possible As for any situation not listed in the error information mentioned above please contact our company as soon as possible Tel 886 2 86671897 MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 23 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Chapter VI Attentions Please confirm whether the transformer suitable for the voltage in the situation where the analyzer 1s used before using it Please connect the analyzer with power supply to warm up for an hour before using it Please store the analyzer in a location without direct sunlight at room temperature Do not place the analyzer in a location with much dust please Please store the analyzer in a location unlikely to shake and please do not keep it under heavy pressure during transportation e Please operate the analyzer with genuine consumables from our company please contact our company if you need to order the consumables at telephone number 02 8667 1897 Do not place the analyzer XacPro E301 close to a strong magnetic field or high power electrical products section I Cleaning amp Maintenance 1 You only need to use a piece of soft cloth soaked with water or mild solvent to wipe and clean the analyzer 2 Please do not use any organic solvent to clean the housing Or accessories 3 Please do not
163. pliance inlet C i 6 11 4 Disconnecting devices Electrically close to the SUPPLY 6 Switches and circuit breakers No switch is used as the N A disconnection device Separable plug without locking device When used as disconnection device A A A A Meets IEC 60947 1 and IEC 60947 3 lt Marked to indicate function Not incorporated in MAINS cord Does not interrupt PROTECTIVE EARTH CONDUCTOR 6 Appliance couplers and plugs m m Ls a a O 61142 EE Where an appliance coupler or separable plug is used as the disconnecting device see 6 11 3 2 EN u LS lt 4 1 4 2 Readily identifiable and easily reached by the operator Single phase portable equipment cord length not more than 3 m PROTECTIVE EARTH CONDUCTOR connected first and 60320 inlet is used disconnected last 7 7 PROTECTION AGAINST MECHANICAL HAZARDS I Equipment does not cause a mechanical HAZARD in Operation not leads toa NORMAL nor in SINGLE FAULT CONDITION mechanical hazard in normal or single fault condition Contomivisciededby72077 Oooo Emmemdpsmaesmooaiondes ore cause inary aura nomwacuseand 11 11 1 lt T1303269 762 gt Page 26 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict Do not cause injury during SINGLE FAULT CONDITION Moving parts Moving part are enclosed HAZARDS from moving parts limited
164. pplementary information No Protective impedance lt 1303269 762 Page 50 of 66 IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark TABLE CLEARANCES and CREEPAGE distances Form A 13 PRO ENCLOSURES and protective barriers 8 Mechanical resistance to shock and impact e Impedance Overcurrent protection basic insulation between MAINS parts ETE Protective impedance Integrity of CLEARANCES and CREEPAGE distances Current or voltage limiting device NM Location Measured Verdict Mechanical tests note Test at Measured after test Verdict Comments initial 6 7 max if required see Form CLEARANCE Applied Rigidity Drop RATED CREEPAGE CLEARANCE A 5 force 8 2 8 3 ambient DISTANCE mm J Static Impact Normal Hand held 10 5 1 mm 8 2 1 8 2 2 8 3 1 Plug in Primary to gt 3 gt 1 5 v v v 40 gt 3 gt 1 5 accessible parts ad NOTE Refer to Form A 14 for dielectric strength tests following the above tests Supplementary information lt T1303269 762 Page 51 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 TABLE Dielectric strength tests FormA14 P 4 4 4 1 b Conformity after application of SINGLE FAULT CONDITIONS T 6 4 Primary means of protection _ Connections to external circuits 7 6 7 Insulation requirements see Annex K i 6 10 2 Fitting of non detachable MAINS supply cords 2 Eliminating or reducing the
165. priate methods of re sterilization 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 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 1n accordance with Section 13 1 no instructions for use are needed the information must be made available to the user upon request details of any further treatment or handling needed before the device can be used for example sterilization final assembly etc in the case of devices emitting radiation for medical purposes Appli Standard Sub clause s cable or not 23 Report Document Comments Clause Description Appli Standard Sub clause s cable or not 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 precauti
166. r 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 a Xac o b Xac o lt X ac o M L ay u J kei yy 4 amp 77 T a gt E a 7 D M MU us Y s rc 4 Y RES 4 X a W TRY NS ML Kis T AU IKT D SUA T KU Nr Ya x Sila 70K Ww yes z Sat wes AKL 7O PES 7K NOK UAM y SOK AN TAR TKK Fig 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 y of the reagent To quantify the reduction in the y4 of magnetic reagent due to the binding between magnetic nanoparticles and biomolecules hereafter is defined as IMR 96 aco Xaco Xac o 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 IMR E B 2 2 0 I Cy P where A B o and y are fitting parameters 1 2 3 Principle of Magnetic Immunoassay Analyzer XacPro E According the mechanism of IMR ac magnetic fields are applied to magnetic reagent The time evol
167. r the instructions for use which directly or indirectly led to the death of a patient or user or of other persons or to a serious deterioration in their state of health or any incident that requires intervention by a medical care professional to preclude permanent impairment of a body function or permanent damage to body function or unanticipated damage to body structure 4 7 Near Incident a near incident is an incident that was prevented due to early detection of the potential discrepancy Note in Europe near incident is considered as an Incident 4 8 Safety Related Complaint A complaint related to an incident or to a near incident 4 9 Serious public health threat Any event type which results in imminent risk of death serious deterioration in state of health or serious illness that requires prompt remedial action This would include events that are of significant and unexpected nature such that they become alarming as a potential public health hazard 4 10 Unanticipated A deterioration in state of health is considered unanticipated if the condition leading to the event was not considered in the risk analysis 4 11 Use error Act that has a different result to that intended by the manufacturer or expected by the operator of the medical device 4 12 Vigilance Reporting Mandatory reporting to the authorities of any deterioration in the characteristics of the device or its functionality which cause or may
168. rature of windings NORMAL CONDITION and or SINGLE FAULT CONDITION 10 3 Other temperature measurements Operating conditions Max setting Frequency 50 50 Hz Test room ambient temperature ta 23 7 23 6 90 864 V Test duration nenn Part Location E mm Verdict N me IL E E NE MN M ECNE Transformer coil power board 1 781 830 1 P Transformer coil power board 532 581 1 P Transformer coil power board 3 503 550 1406 P Transformer coil power board 444 458 w5 P PcB mderQ 487 54 w5 P PCB undere 494 510 w5 P case Tenpecizeooiowia ms es e eee eee r oe LR Jls Ll O 1x P Js t Js Ce de C cc ewwer ar 0 Exwmuetde ea 5 5 mwn 4 Supplementary information lt T1303269 762 Page 56 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 1052 TABLE Resistance to heat ofnon metalic eNcLosunes Fom A22 P Non operative treatment cccccccsseeeeesseeeeeneeeees Eo ox Emply ENCLOSURE cr dI n Operative treatment d Temperature during tests sssssss LI NN ENCLOSURE samples tested were Alst 0 Webss Nodomordwour P ee ee NOTE Within 10 minutes of the end of treatment suitable tests in acc to 8 2 and 8 3 must
169. rips withstand four times weight N A No lifting device N A A 5 2 5 3 Lifting devices and supporting parts Rated for maximum load or tested with four times maximum static load A Wall mounting The equipment is not for N A wall mount lt ss 6 Mounting brackets withstand four times weight N A 7 Expelled parts Equipment contains or limits the energy Complied with the test of 4 4 re ra fs 7 Protection not removable without the aid of a tool Tool is needed RESISTANCE TO MECHANICAL STRESSES Equipment does not cause a HAZARD when subjected to mechanical stresses in NORMAL USE Normal protection level is 5 J Tested with 5J 8 1 lt T1303269 762 gt Page 28 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Clause Requirement Test Result Remark Verdict 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 easily touched c only occasional access during NORMAL USE d IK code in accordance to IEC 62262 marked or symbol 14 used with full information in the documentation N A N A Tested with 5J N A N A For non metallic ENCLOSURES rated below 2 C ambient temperature value chosen for minimum rated temperature Impact energies between IK values the IK code marked for nearest lower value Conformity is checked
170. rop height or angle of Drop from 30 Non metallic ENCLOSURES cooled to minimum RATED ambient temperature if below 2 C EN Drop test conducted with an height of 1 m 8 101 Transport and storage IEC 61010 2 101 When packed in the manufacturer s packaging 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 IEC 61010 2 101 9 PROTECTION AGAINST THE SPREAD OF FIRE i No spread of fire in NORMAL 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 EMI NE E Conformity is checked by minimum one or a combination of the following see Figure 1 1 a Fault test of 4 4 or see Form A 1 and Form A 2 b Application of 9 2 eliminating or reducing the c Application of 9 2 containment of fire within the equipment lt T1303269 762 gt Page 30 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark 9 2 Eliminating or reducing the sources of ignition within the Considered to be reduced equipment to a tolerable level a Limited energy circuit see 9 4 or Not determine to Limited N A energy circuit 1 2 BASIC INSULATION provided for parts of see Form A 5 and A 14 different potential or Insulation between parts at different potentials
171. rovided with the relevant safety statements b technical specification C d e information to mitigate residual RISK f accessories for safe operation of the equipment specified g guidance provided to check correct function of the equipment if incorrect reading may cause a HAZARD from harmful or corrosive substances of name and address of manufacturer or supplier Information specified in 5 4 2 to 5 4 6 Nr 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 MEME Information shall be given about any RISKS not otated in the manual 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 IEC 61010 2 101 Documentation includes i a Supply voltage or voltage range 100 240V Frequency or frequency range See page 1 Power or current rating ccccccceeseeceeeeeeeees See page 1 b Description of all input and output connections in Stated in the manual accordance to 6 6 1 a C RATING of insulation of external circuits in accordance to 6 6 1 b d Statement o
172. rying capacity to MAINS Appliance inlet has enough supply TERMINALS current carrying capacity to mains 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 conductor Applied first oecured independently Unlikely to be removed by servicing h PROTECTIVE CONDUCTOR of measuring circuit 1 Current RATING equivalent to measuring circuit TERMINAL J i FUNCTIONAL EARTH TERMINALS allow independent connection j If a binding screw used for PROTECTIVE CONDUCTOR TERMINAL Suitable size for bond wire Not smaller than M 4 No 6 At least 3 turns of screw engaged Passes tightening torque test k Contact pressure not capable being reduced by deformation of materials N A N A N A N A N A N A N A N A N A N A N A N A N A N A 2 PROTECTIVE BONDING shall not be interrupted Devices used for indirect bonding in test and measurement circuits are permitted to be part of the PROTECTIVE BONDING Impedance of PROTECTIVE BONDING of plug connected 0 010hm measured passing 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 less than 0 2 Ohm if equipment is provided with non Inlet is used N A detachable cord 5 2 Bonding impedance of PERMANENTLY CONNECTED s
173. s The QA manager will keep in continuous contact with the reporting customer A copy of all correspondence with the reporting customer will be filed together with the complaint form The QA manager shall summarize the results of the investigation and shall prepare a written response to the customer including a detailed description of the corrective action performed The CEO and or the QA RA Director will approve the written response A copy of the written response will be kept together with the complaint form In order to close a complaint the QA manager shall 5 7 4 1 Review the Customer complaint form to verify its completeness and accuracy 5 7 4 2 Sign the Customer complaint form 5 7 4 3 Close the complaint in the complaints log file 5 8 Corrective action 5 8 1 The QA manager and Senior VP Operations shall determine whether additional corrective actions are required and will perform a follow up on each corrective action until it is completed If no corrective actions were deemed to be necessary the rationale for this decision shall be documented in the complaint form Corrective actions shall be performed according to Corrective and Preventive Action procedure 5 9 Handling of safety related complaints 5 9 1 5 9 2 If the nature of the complaint is categorized as a safety related it should be immediately reported to the CEO and QA RA Director In any case of safety related complaint it is manda
174. s custom made device if the device is intended for clinical investigations the words exclusively for clinical investigations any special storage and or handling conditions any special operating instructions any warnings and or precautions to take year of manufacture for active devices other than those covered by e This indication may be included in the batch or serial number m where applicable method of sterilization 21 Report Document XacPro E ver 201309 Comments Appli cable or not Description 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 3 6 identify the correct devices or equipment to use in order to obtain a s
175. s device is General IVD Article 9 non List A or B not for performance evaluation not for self testing according to Annex II of 98 79 EC on In Vitro Diagnosis Medical Device Directive 1 2 9 Conformity Assessment Route This declaration is based on conformity assessment procedure of Directive 98 79 EC Annex III excluding section 6 1 3 Licences and Certificate 1 3 1 Certificates of Quality system e Certificated with ISO13485 2003 TW 14 10079 e Certificated with ISO 9001 2008 TW 14 10080 e Certification of Good Manufacturing Practice GMP 053711 1 3 2 Certificates of CE e Certificate of Compliance with European Low Voltage Directive 2006 95 EC T1303269 762 e Applicable to EUROPEAN COUNCIL DIRECTIVE 2004 108 EC The Information Technology Equipment 1303269 1 3 3 Certificates of Taiwan e Approval of Class I Medical Device in Taiwan 005218 10 Reference Z1 222 2 9 2 4 2 53 2 6 C Y Hong C C Wu Y C Chiu S Y Yang H E Horng and H C Yang 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 2012 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
176. se 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 Ans 2 L7 Ans C 2 18 AnS C 2 19 Ans C2 20 Ans 221 Ans 2 22 Ans 2 23 Ans 224 Ans C225 Ans C 2 26 Ans Does the medical device influence the environment Yes it provides magnetic field and heat Are there essential consumables or accessories associated with the medical device No Is the maintenance and or calibration necessary Yes the maintaining methods should be describing in operation manual Does the medical device contain software No Does the medical device have a restricted shelf life Yes Are there any delayed and or long term use effects It may occur To what mechanical forces will the medical device be subjected No the XacPro E is not working by mechanical force What determines the lifetime of the medical device Using frequency Is the medical device intended for signal use Yes Is safe decommissioning or disposal of the medical device necessary Yes Does installation or use the medical devices require the special training
177. sible compatible with the intended purpose whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes The measurements made by devices with a measuring function must Clause Description Appli Standard Sub clause s cable or not 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 control 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 design
178. so 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 MagQu Carcinoembryonic Antigen CEA IMR reagent MF CEA 0061 made by MagQu Co Ltd With CEA antigen provide by MagQu Co Ltd The signal from the software should be 30 to 60 After sample test the serial number on the labeling will be attached two more numbers for software version before MQ which are the last two numbers of serial number for better traceability 4 1 5 Packing List Packing materials Quantity XacPro E l set Operating and maintaining manual 1 set Labeling l set 4 2 Product Validation amp Verification 4 2 1 Compliance with Standards 4 2 1 1 Issued Standards The XacPro E is issued for Low Voltage Directive 2006 95 EC with standards EN 61010 1 2010 Third Edition and EN 61010 2 101 2002 which are also including In Vitro Diagnosis IVD Directive 98 79 EC on Oct 16 2013 and Electromagnetic Compatibility Directive 2004 108 EC with standards EN 61326 1 2013 and EN 55011 2009 A1 2010 Group 1 Class A on Oct 9 2013 by Cerpass 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 The other standards are listed on Chapter 1 4 2 2 Performance Eva
179. sources of ignition within the equipment NEM 4 C Limited energy circuit Record the fault test or treatment applied before the dielectric strength test Humidity preconditioning required Test site altitude m Test voltage correction factor see Table 10 o a D Location or Working voltage Test voltage Comments Verdict references from Forms A 2 V r m s peak d cV and A 5 L N to Earth 1680Vac No break down PRO L N to accessible parts 3480Vac No break down OP o L N to secondary 3480Vac No break down OP Supplementary information 6 10 2 TABLE Cord anchorage Form A 15 Location Mass Pull Verdict Torque Verdict Comment kg N Nm Dielectric strength test for 1 min 6 8 3 1 Supplementary information lt 1303269 762 Page 52 of 66 O IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark TABLE Protection against mechanical HAZARDS Form A 16 Limitation of force and pressure O Gap limitations between moving parts 4mm Clause 7 3 4 Clause 7 3 5 1 Clause 7 3 5 2 Minimum gaps mm Maximum gaps mm Part Location Contact pr sure max 250 N Torso Head Leg Foot Toes Arm Hand Finger Head Foot Finger Verdict Comments max 50 N cm 3 cm 500 300 180 120 50 120 100 25 120 35 4 max 150 N max 0 75 s Enclosure Lo e ee Eee Supplementary information lt T1303269 762 Page 53 of 66 OQ IEC EN
180. t Medical devices Symbols to be used with medical device labels labelling and information to be supplied Part 1 General requirements
181. ted by the manufacturer for the design and Directive 98 79 EC construction of the devices must conform to safety principles taking ENISO13485 2012 account of the generally acknowledged state of the art ENISO14971 2012 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 Standard Sub clause s EN 61010 2 101 2002 Report Document i System Cert No TW 14 10079 _ Product Master file No MF02 Risk Management Report No RM02 02 Product research file XacPro E ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validation report No RD02 Risk Management Report No RM02 02 Product research file XacPro E Appli cable or not Description 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 characteristics and performances referred to in Sections 1 2 and3 No must not be adversely affected to s
182. thin the EU national competent authorities can be found at http europa eu int comm enterprise medical_devices ca ca_vig htm 5 13 Reporting authorities Field Safety Corrective Actions FSCA As applicable the following authorities shall be reported on FSCA taken on a basis of incidents 5 13 1 5 13 2 5 13 3 5 13 4 Competent Authorities of all countries affected The Competent Authority responsible for the EU Authorized Representative The EU Authorized Representative The Notified Body that certify the device 5 14 Vigilance Reporting 5 14 1 5 14 2 In Europe the reporting shall be done initially by the Incident Report form followed by follow up report and after the complaint is closed by final report unless the initial and the final report are combined into one report The final report shall include a written statement of the outcome of the investigation and of any action Examples of actions may include 5 14 2 1 No action 5 14 2 2 Additional surveillance of devices in use 5 14 2 3 Preventive action on future production 5 14 2 4 FSCA 5 15 The timetable for the initial reporting of an incident Europe 3 19 1 5 15 2 5 15 3 5 15 4 Serious public health threat immediately but not later than 2 calendar days Death or unanticipated serious deterioration in state of health Immediately without any delay that could not be justified after establishing a link between the
183. thorities have been advised of the FSCA Contact point for customers how and when to reach the designated person 5 19 Following the handling of a critical and or safety related complaint and as required appropriate notification shall be sent to all company distributors 5 20 All the data regarding the complaint including the information provided by the customer the forms and the investigation report and conclusions the corrective action taken and the written response to the customer will be kept in the company archive for at least five years from the date of distribution of the last unit of the same device family 5 21 Customer Complaints and the following corrective actions including its effectiveness shall be reported in management reviews 6 Responsibility 6 1 The QA manager is responsible to verify the implementation of this specification 10 Chapter 11 Conclusion 11 Conclusions The Magnetic Immunoassay Analyzer XacPro E designed by MagQu Co Ltd is used to measure the change in the ac magnetic susceptibility of a sample over time If the sample 1s a mixture of a magnetic reagent and an object to be detected XacPro E can be used to detect the concentration of bio molecules in the object according to the change in the ac magnetic susceptibility which is so called immunomagentic reduction With this technical file to illustrate the Magnetic Immunoassay Analyzer XacPro E developed by MagQu Co Ltd has been desi
184. til 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 rr o J Authorised by SGS United Kingdom Ltd Systems amp Services Certification Rossmore Business Park Ellesmere Port Cheshire CHES JEN UK t 44 0 51350 5566 1 44 0 151 350 6600 www sgs com S65 5001 8 01 0311 Page 1 o1 i ROUMANIE MM NI Ma ne cnn ba eke Dee CONNU Certiceion Service scodssible at wer aga comiter andi tention hs drawer tn the binanting of iie IERT iM tiec ectablched herein Tha aubanfety of iha document mery be wr at tip www sgi conveni Dur CemanCertified Chent Diectorie s Tenio Cart stoniness Anp unauthorized alteration Kcroery or falslcatcn of the ct appearance of ta documpni d uiai and offenders may be prosscumd to tha Reed end of the haw Certification of Good Manufacturing Practice GMP MINISTRY OF HEALTH AND WELFARE REPUBLIC OF CHINA TAIWAN Issue Date AP R2 2 NoU 5 3 Ton 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 manufactur
185. tinguish between identical or similar products sold in both sterile and non sterile condition Appli cable or not Standard Sub clause s 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 any biological pathway which can be imagined Clause 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 Description Standard Sub clause s Appli cable or not YES 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 YES the risk of injury in connection with their physical features including the volume pressure ration dimensi
186. tion Before connecting a computer please confirm whether the computer is started Switch on power of the product after starting the computer Before shutting down the product and disconnecting the computer please interrupt and remove relevant software at first 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 confirm 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 1s taken off 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 MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 2 Website www magqu com Email Box info ma
187. tm measured temperature t tn corrected tr t 40 C or max RATED ambient tnax 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 lt T1303269 762 Page 63 of 66 PHOTOS lt 1303269 762 Page 64 of 66 PHOTOS Page 65 of 66 lt 11303269 762 gt PHOTOS lt T1303269 762 Page 66 of 66 OQ 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 5 2 EMC TEST REPORT o Ce CERPASS TECHNOLOGY CORP Report No TEEX1303269 EMC TEST REPORT According to EN 55011 2009 A1 2010 Group 1 Class A
188. to a tolerable level with the conditions specified in 7 3 2 and 7 3 5 RISK assessment in accordance with 7 3 3 carried out N A Access to HAZARDOUS moving parts permitted under following circumstances 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 N A b If operator access is unavoidable outside normal use following precautions have been taken 1 Access requires TOOL Access is not possible N A without the use of a tool 2 i 3 Warning markings on covers prohibiting access by untrained operators Statement about training in the instructions N A or symbol 14 with full details in documentation N A C Stringent measures N A 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 150 N Temporary force below 250 N for an area at least of 3 cm for a maximum duration of 0 75 s Ji Gap limitations between moving parts see Form A 16 N A 2345 Access normally allowed Moving part are enclosed N A If levels of 7 3 4 exceeded and body part may be N A NA 733 Moving part are enclosed measures as specified in Table 12 7 3 4 N A N NIN Co Co oo C1 inserted minimum gap as speci
189. tor No hazards and no accessible voltage over the limit PRO 4 4 2 7 3 Short output of transformer N2 2Hr Until thermal steady and no accessible conductive parts have become hazardous live and no over temperature limits of Table 20 4 4 2 10 4 Locked fan top 60min No accessible conductive parts have become hazardous live and no over temperature limits of Table 20 4 4 2 10 5 Locked fan rear right 60min No accessible conductive parts have become hazardous live and no over temperature limits of Table 20 4 4 2 10 Locked fan rear left 60min No accessible conductive parts have become hazardous live and no over temperature limits of Table 20 4 4 2 12 7 Short Capacitor C61 2Hr Until thermal steady and no accessible conductive parts have become hazardous live and no over temperature limits of Table 20 NOTE Td Test duration in hh mm ss Record dielectric strength test on Form A 14 and temperature tests on Form A 21 Record in the comments column for each test whether carried out during or after SINGLE FAULT CONDITION Supplementary information lt T1303269 762 Page 42 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark 5 1 3c TABLE MAINS supply Form A 3 65 3 1 17 105 3 Sample is operated with all parameters set at maximum setting alg Sample is operated with all parameters set at maximum setting parameters set at maximum setting 64 7 Sample is operated wit
190. tory to perform investigation and risk assessment review in order to evaluate the affect of the complaint on product risks 2 9 As required the OA manager is responsible to verify notification of the appropriate regulatory authorities 5 10 Vigilance general principles 5 10 1 5 10 2 5 10 3 Based on the complaint details the CEO QA RA Director and QA manager shall decide if the complaint is a reportable complaint and should be reported to the relevant authorities according to the European vigilance reporting system The QA manager shall notify the relevant authorities about incidents and field safety corrective actions when the reporting criteria are met As a general principle there is predisposition to report rather than not to report in case of doubt on the reportability of an incident 5 11 Non reportable events Europe only Reporting under the European medical device vigilance system is not required in the following conditions 5 11 1 5 11 2 5 11 3 5 11 4 5 LL 5 5 11 6 5 11 7 Deficiencies of a device found by the user prior to its use that are always detected Event caused by patient conditions The only cause for the event was that the device exceeded its service life or shelf life and the failure mode is not unusual Use error which did not result in death or serious deterioration in state of health or serious public health threat Protection against a fault functioned c
191. uch 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 which can occur during normal conditions of use The devices must be designed manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer YES Any undesirable side effect must constitute an acceptable risk when weighed against the performances intended YES Standard Sub clause s Directive 98 79 EC ENISO13485 2012 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 Directive 98 79 EC ENISO13485 2012 ENISO14971 2012 Report Document ISO 13485 Quality System Cert No TW 14 10079 _Design Verification and Validation report No RD02 ISO 13485 Quality System Cert No TW 14 10079 _ Product Master file No ME02 _Risk Management Report No RM02 02 Product user Manual XacPro E ver 201309 System Cert No TW 14 10079 _Risk Management Report No RM02 02 Comments The device never directly touches patients in any material or energy pathway which can be imagined Requirements regarding design and construction Clause Description Appli cable or not Demonstration of
192. uct with a proper system is recommended for the purpose of ensuring most materials can be recycled and reused appropriately MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 4 Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 Chapter I Brief Introduction to Applications of Magnetic Immunoassay Analyzer The Magnetic Immunoassay Analyzer XacPro E301 launched 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 XacPro E301 is advantageous for bio molecular assays in many ways such as its operation is very simple there is no need for users to calibrate concentration of the to be detected bio molecules it adopts CAA Computer Automatic Analysis with high accuracy and sensitivity and can detect low concentration bio molecules Therefore XacPro E301 can be applied in not only research but clinical diagnosis and field trials To be detected bio molecules mentioned above include protein cytohormone virus nuclei acids bacteria even small molecular compounds XacPro E301 can help you to establish standard detection curves for new kinds of bio molecules to be detected further to measur
193. ufficient warning in the operation and maintain manual 3 4 Inadequate operating instructions 5 7 Incorrect measurements and other metrological aspects 6 1 confusing or missing instructions for use 6 6 ambiguous or unclear presentation of settings measurements or other information 7 2 Lack of or inadequate specification for maintenance including inadequate specification of post maintenance functional checks 7 3 Inadequate maintenance 7 8 Functional Failure Inadequate setting may damage the device 36 ALARP 4 Acceptable 4 Acceptable 4 Acceptable 4 Acceptable 4 Acceptable 13 ALARP Inadequate reagent may cause incorrect measurement Inadequate reagent may cause incorrect measurement Inadequate reagent or inadequate measuring steps may cause incorrect measurement The manual may lose some situations which seldom occur The manual may lose some situations which seldom occur Hardware may shut down for some unknown reasons and it will cause incorrect measurement or give electrical shot to operators 6 Acceptable Setting devices by users themselves is forbidden The operators should be well trained The operators should be well trained The operators should be well trained Also the measuring steps should be clearly described in the operation and maintaining manual The sales or agent should do setting training to operators while the device first setting
194. uired where a HAZARD could occur from the discharge of biological and chemical substances and hot fluids IEC 61010 2 101 j details of protective measures relating to hazardous No radiation hazards N A radiation see clause 12 IEC 61010 2 101 k connections to the supply IEC 61010 2 101 l for PERMANENTLY CONNECTED EQUIPMENT Not a permanently N A only IEC 61010 2 101 connected equipment No drainage required N A 1 MAINS supply requirements and details of N A connections including the RATED temperature of the cable required at maximum RATED ambient temperature IEC 61010 2 101 2 requirements for any external switch or circuit breaker see 6 11 2 1 and external overcurrent N A 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 IEC 61010 2 101 m requirements for special services for example air N A cooling liquid including pressure limits IEC 61010 2 101 lt T1303269 762 gt Page 10 of 66 OQ IEC EN 61010 1 IEC EN 61010 2 101 Requirement Test Result Remark Verdict 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 IEC 61010 2 101 b an instruction not to position the equipment so that it is difficult to operate the discon
195. ules 1 Coils Coils include excitation coils pick up coils Sample is located inside excitation coils 2 Electronics Electronics are consisted of a signal generator BP filter amplifier temperature control modules and DAQ card The detailed specifications and dimensions of all the components are described in Chapter III of the Operation amp Maintenance Manual 1 2 5 Functional Feature The functional features of XacPro E are listed below e Specifications of the power converter Input 100 230 VAC Output Max 24VDC 200W e Specifications of AC Wave Generator Output power AC 3V to AC 4 24V 50mA 50mA Output Frequency 100 to 50 kHz e Specifications of amplifier circuit Wave band 1 k to 30 kHz Voltage magnification 1 to 2000 e Specifications of solenoid assembly Excitation coil resistance 100 200 Q coil density 400 550 turns cm Pick upcoil resistance 40 70 Q coil density 400 550 turns cm e Software platform Windows XP Windows 7 XacPro E 1s capable of quantitatively detecting the low concentration of bio targets with aids of reagents with adequate bio functionalized magnetic particles The low detection limits using XacPro E are listed for examples Bio target Reagent Low detection limit MagQu Carcinoembryonic CEA Antigen CEA IMR reagent 0 13 ng ml MF CEA 0061 1 2 6 Warning And Precautions 1 Prevent fire or personal injury Use proper power line Please use only the power line d
196. ules are described in the following sections Temperature Control Box Detection Box Jus wa om om am eee D UM h i Temperature contro Module Seeeeeeeseeeeaeac ei m ee A TE Cooler k I I c o om m 1 Kee n o c co occ ccc ccc Fig 1 Picture and scheme of XacPro E301 MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 1 Website www magqu com Email Box info magqu com Tel 886 2 86671897 Fax 886 2 86671809 Section I Power Converter AC DC The section will introduce icon and function of the power converter AC DC 1 Diagram The power converter is as shown in Fig 2 Input voltage of the power converter ranges from 100 V to 240 V The output is direct current voltage 11V which used as the power necessary for operation amplifier in other circuits CS 1 recs O P1 REG 3 ress JC o Ps 115V 230V Fig 2 XacPro E301 Power supply diagram 2 Function Since electric circuits of other components of XacPro E301 are driven by DC voltage the power converter is used to convert AC power of city mains into the DC power required by the electric circuits when XacPro E301 works The DC power after conversion provides 11 V DC voltage MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax
197. ur information User Name Organization p ooo Install this application for Anyone who uses this computer all users Only for me ASUG 1 InstallShield MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 16 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 11 Choose the folder path and click next The installation will start after users click Install and finish when users click Finish r 39 ADLINK USB DASK v1 00 InstallShield Wizard Destination Folder Click Next to install to this folder or click Change to install to a different folder Install ADLINK USB DASK v1 00 to C MDLINKYIUDASK InstallShield r 13 ADLINK USB DASK v1 00 InstallShield Wizard Ready to Install the Program The wizard is ready to begin installation If you want to review or change any of your installation settings dick Back Click Cancel to exit the wizard Current Settings Destination Folder C ADLINK UDASK User Information Name ASUG Lab2 Company MaqOQu InstallShield r p ADLINK USB DASK v1 00 InstallShield V izard InstallShield Wizard Completed The InstallShield Wizard has successfully installed ADLINK USB DASK v 1 00 Click Finish to exit the wizard MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New
198. ure box which are designed for the temperature box and the detection box and need to be switch on and off simultaneously A power line should be connected on the left of the switches and the 15 pin connector on the left of the power line should be jointed to the 15 pin connector on the detection box There are two 9 pin connectors on the right of the switches between which the left one should be jointed to the 9 pin connector on the left of the 15 pin connector on the detection box and the right one should be jointed to the 9 pin connector on the right of the 15 pin connector mentioned above 3 There is a control panel in the front of the temperature box After opening the acryl cover push down the green button lt and then adjust the temperature with green numbers below Commonly the most appropriate working temperature is about 5 to 10 degrees above room temperature MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 1 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 MagQu Co Ltd 3F No 12 Lane 538 ZhongZheng Road Xindian District New Taipei City 231 Taiwan 20 Website www magqu com Email Box info magqu com_ Tel 886 2 86671897 Fax 886 2 86671809 Section III Xac Measurement Procedule 1 Launch XacPro E and setting the measuring points 1 point for 5 seconds 2 Setting the path of data
199. ution ac magnetic signal of magnetic reagent is detected Thus the magnetic immunoassay analyzer XacPro E 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 Then the sensed ac magnetic signal of reagent is transferred to an electronical signal The signal which is first leaded to a band pass filter and amplifies 1s acquired by DAQ system and transport to computers via USB cable 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 The temperature control module with TE cooler can help the bio reaction of the reagent more stable All the details of working principle of XacPro E as shown in Fig 3 are available in Refs 2 5 and 2 6 Temperature control Module C3 Fig 3 Schematic configuration of XacPro E for detecting ac magnetic signal of magnetic reagent 1 2 4 Hardware A picture to reveal the hardware of XacPro E is as shown in Fig 4 Fig 4 Magnetic immunoassay analyzer XacPro E 1s consisted of three modules sensing part coils and electronics Briefly speaking XacPro E is consisted of two mod
200. ween adjacent 0 00 Pass max d c between any 0 005 Flicker Long term Flicker indicator Plt 0 00 Short term Flicker indicator Pst Plt Interval Pst 1 0 00 2 0 02 a 0 02 4 0 00 5 0 02 6 0 02 7 0 02 8 0 00 9 0 00 10 0 02 11 0 02 12 0 00 Pst classifier Duration Flicker 0 15 0 00 0 75 0 00 1 0 0 00 1 5t 0 00 2 2 0 00 3 0 00 4 0 00 6 0 00 8t 0 00 10 0 00 13 0 00 17 0 00 30 0 00 50 0 00 BOs 0 00 Test engineer nn Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 27 of 50 Cc a CERPASS TECHNOLOGY CORP Report No TEEX1303269 C 7 4 Test Photographs ee Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 28 of 50 CE e CERPASS TECHNOLOGY CORP REPON MO TEPA UIO 8 Electrostatic Discharge Immunity Test 8 1 Test Procedure a In the case of air discharge testing the climatic conditions shall be within the following ranges e ambient temperature 15 C to 35C e relative humidity 30 to 60 e atmospheric pressure 86 KPa 860 mbar to 106 KPa 1060 mbar b Test programs and software shall be chosen so as to exercise all normal modes of operation of the EUT The use of special exercising software is encouraged but permitted only where it can be shown that the EUT is being comprehensively exercised c The test voltage shall be increased from the minimum to th
201. y protection h Ifthe actual operating signal sources are not available that may be simulated Under no circumstances may the test level exceed the product specification The test shall be carried out according to a test plan i To find all critical points of the duty cycle of the equipment a sufficient number of positive and negative test pulses shall be applied For acceptance test previously unstressed equipment shall be used to the protection devices shall be replaced 11 2 Test Severity Level Open circuit test voltage 1096 KV Specified NOTE X is an open class This level can be specified in the product specification Cerpass Technology Corp Issued Date Oct 09 2013 Tel 886 2 2655 8100 Fax 886 2 2655 8200 Page No 39 of 50 o CE CERPASS TECHNOLOGY CORP Report No TEEX1303269 11 3 Measurement Equipment Instrument Manufacturer Model No No SeralNo No Calibration Date Date Valid Date Date TESQ NSG3060 TESQ NSG3060 1385 2013 4 11 2014 4 10 11 4 Test Result and Data Final Test Result PASS Pass performance criteria Required performance criteria B Basic Standard IEC 61000 4 5 Product Standard EN 61326 1 Test Voltage Input AC Power Port 0 5 kV 1 0 kV 2 0 kV Temperature 25 C Relative Humidity 58 Atmospheric Pressure 1011 hPa Test Date Oct 03 2013 Power Port Waveform 1 2 50us 8 20us Repetition rate 60 sec Time 5 tim

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