Hangzhou Shensheng Stelization Equipment Co, CONTENT 4, Installation instruction 2, Operating Instruction Enclosure: the safety rules of ethylene oxide sterilization 3, Operating manual Enclosure: Computer operating instructions 4, The main technical drawings Enclosure: Pipeline diagram, electrical diagram and instalation location plan 5, Factory report Enclosure: Certificate of ethylene oxide sterlizer Factory inspection report of ethylene oxide stelizer 6, Maintenance schedule Enclosure: Common trouble shooting ist 7, The comprehensive test of ethylene oxide sterilization knowledge 8, Company related certificates (3pcs certificates & 1 pc photo) 9, Ethylene oxide chemical indicator sheot{2 pes) 10, Related data 1), Gompieton receipt of etiylene oxide sterlizer (feedback to us) 2), VOCT of ethylene oxide sterilzer (feedback to us) 23), Main parts instructions, Cartifcate of approval & related data of ‘Measuring instrumentsHangchou Shensheng Stritzation Equipment Co. te Installation Instruction ‘The equipment installation should be undor our engineers’ instruction! The ethylene oxide is inflammable, explosive, toxic gas,jt mustensure the security of future use when installation ! 4, Shipment 4.1 The sterlizer was consists of stelizer chamber auxiliary frame(cabine!) clectrical control cabinet and computer desk 4.2 parts will be detached before loading. The computer wl be loaded in ‘chamberthe auxiliary frame,electrical control cabinet will be on outs. 1.3 Shipment weight of sterilizer (Included all auxiary parts): 14Ton, ‘Shipment dimension(LxWxtH):9400mm x 3170mm x 240mm 2, Sterilizer location (refer to the installation diagram) 2.1 Sterlizer chamber 2.1.1 Sterilizer chamber dimension (LxW#) ‘dimension: 8975mm x 1365mm x 1708mm b.chamber size(w/ support frame): 9400mm x 170mm x 240m 2.1.2 Chamber weight (Ground loading) ‘a.wlo adding water: 11Ton b.w full water: 13Ton 2.2 Auliay frame 2.2.1 Frame dimension(LxWxH):1200mm x 1400mm x 200mm 2.2.2 Frame weight ‘wo adding water: 1Ton bw full water: 4.5Ton 2.3 Electric control cabinet (harp type) 2.3.1 Cabinet dimension(LxiNxH):1100mm x 1400mm x 1800mm | 2.3.2 Cabinet weight: 0.5Ton 3, Installation of ethylene oxide sterilizer Below factors should be attention during instalation, a.The safety of strilzer, e.g flameproof, ati-explosion.et.Hangzhou Shensheng Steriization Equipment Co. ».Power supply.ir supply.drug and water supply.drainage, Maintenance of sterilizer, Rationality and normalization of sterilization workshop production process ‘Requirements of sterilization process 3.1 The composition and distribution of stelization workshop ‘The stelization workshop was consist of pre-hotting room steriization room, control room auxiliary room,gas room. degassing room finished Froducts warehouse, 3.4.1 Pre-heating room\if any)—placed pre-sterilzation goods It should has special heat source to supply 25~5°C indoor termperature, with humidity monitoring condition, 3.1.2 Sterilization 1oom---placed steriizer chamber Steriization workshop should installed the explosion-proof exhaust fan, ‘explosion-prooffloodight serlization room should has strc isolation condition with other room,withfre-ighting facities, 3.1.3 Control oom-—placed electric control cabinet and computer It should has special switchboard access three-phase five wire,380V 50HZ capacity not less than 30KW power supplyand with good grounding line ‘condition,Grounding resistance < 20M, With air condition facilites, temperature around 20°C, humidity < 85% RH. 3.1.4 Secondary machine room-—-Placed auxiliary frame It'should has water supply.air supplyidrainage conditions. Tap wate” ‘supply pipeline should be not less than G1/2",hydraulle pressure range’ 0.08MPa.-0, 15MIPa,drainage pipe diameter not less than 100mm, 3.1.5 Gas room-—-Store EO gas oylinder room It.chould be with good ventilation conditions,ne hotting source and fre,no direct sunshine indoor temperature should be within 20°. 3.1.6 Degassing room--—force the stelization goods to remove residual It should has special hotting source to supply 25~85°C room temperature, humility monitoring conditions and manklalory exhaust device, 3.1.7 Finished products warehouse—-store the sterilization goods ‘The room must be with better ventilation and aeration 3.2 The installation of steriizer main parts 3.2.4 Sterilizer chamber ‘The sterilizer chamber with whole landing chassis (frame) don not need PantHangzhou Shensheng Steritzation Equipment Co, installation base,but the subgrade should be bear the max load of chamber. Steriizer chamber should be keep horizontal.To be installation and ‘maintenance conveniently around the sterlizer chamber should be keep gap not less 500mm, 3.2.2 Auxiliary framework ‘Auxiliary framework position should be convenient to joint the palin, (988 cireuitelectriccrcult. chamber and electric contol cabinet. Auxliny {framework position should be stable and fastness,To avoid the intense shock ‘when pump working, Water tank drainage pipe, working pump and operating valve should be fed on auxiliary framework,prohibt movel Component instalation position should consider maintenance. Operating valve(manual valve) position should facilitate the operators, 3.2.3 Electrical control cabinet Electric control cabinet position should facilitate the operators,and faciltate to observe the sterilizer chamber machine sets,ete working status. Electric contr! cabinet and auxiliary framework were jointed through ‘aeosynctine despooling, the jointed cable which between electric contro! cabinet and other fitings should be wear pipe. 3.2.4 Computer operation platform Operating platform should has position to place main computer cate, ‘control computer case,monitor printer. Computer should be equipped with dedicated UPS uninterruptible power supply ‘The transmitting and transmission of computer input signal should Consider ant-interference factors. The computer grounding line should be ‘separately among steiizer chamber electric control cabinet.auxiiary framework. 3.8 The instllation(rend) of sterlizer pipeline and gas circuit(refer to pipeline diagram) 3.3.1 Vacdum path ‘chamber-+ vacuum valve-> vacuum pump-» pollution discharge tue 8.32 EO injection path EO gas cylinder fiter~injection valve-+ flowneter-> chamber 3.3.3 Door seat inflation path ir pump-» reducing valve—> electromagnetic valve-+ door seal infation valve-+ door seal 3.3.4 Door seal suction path paniHangzhou Shensheng Striizaton Equipment Co, door seal-» door seal suction valve-- electromagnetic valve—+ vacuum pump 3.3.5 Humicification path vapour source-> fiter—+ valve» chamber 3.3.6 Circulating water oop water tank 1+ valve-> circulation pump-+ valve—+ chamber inner sleeve water tank 4 3.3:7 Vaporizer water loop ‘water tank 1+ valve vaporizer—+ valve-> vaporizer inner sleeve-+ water tank 1 4, Sterilizer pro-onvironment requirement 4.1 Noise control 4.1.4 Max noise <70d8 44.2Average noise 5548 4.2 Residual EO gas emission 4.2.1 Workshop EO 1 kpa/minutes. 3.9 Humidifcation ‘Should humidity when the humidity of inside chamber less than 20%6RH. {turn on the humiiter power switch in advance) 3.9.1 Tum on the humidifier power keep the steam pressure of humitfor Inside rise to 0.3 ~ 0.4 Mpa, i Attention: Steam pressure should not be exceed 0.4Npa, 3.9.2 Open the steam valve of humidifier and drain valve of sterilizer condensate water. Close the drain valve of stelzer condensate water when ‘steam was discharged from drain valve of sterilizer condensate water 3.9.3 Open sterlizer humidification valve transfer humidifier inside steam to steiizer chamber slowly. Close each valve when the steriization hurrdity reach to specified humidity requirement. 3.9.4 Tum off humidifier power. 3.40 £0 gas injection EO gas injection after confirm the sterilization temperature, sterilization pressure, sterilization humiity within bounds. 8.10.1 Tum on vaporizer pump switch, vaporizer pump indleator light bright, that’s vaporizer working starting 3.10.2 Rise the vaporizer temperature to appointed value which PintHangzhou Shonsheng Steriizaton Equipment Co, td steriization process provision, 3.10.3 Weight and record the gas cylinder before injection preset the EO injection dosage. 3.10.4 Open EO injection valve.then open cylinder valve slowiy.ED injection starting, ‘Should monitor closely the pressure gage flowmeter scale weighing and EO gas temperature during EO injection. Attention: is better to control the floater of flowmeter in 1/3 positon W 135Smem=H 176mm Sie Outsider {9400mm-W 317OmH 240mm storm ‘Thickness: Gown + Volumes 20m? Relale weitng,spli ‘iow wachoma, po pra ‘Weling oa ae Pees | conor crac; without tortion. Doors ‘When seat, the dors ot alowed to pen confirm locked aia | Prodveton “The Jacket can witstnd 0.2Mpahydaule pressure, cabins can Performanee | process ; isan .12Mpe ae esse confor =m No defermation, no wae, no Fake. Sars | steitzton ort tyraning ‘0 ation fl component ae with ning nstutons norm indication = [atmin [When seriiton ol working at re with alam sonfoan Dally the two temperature tnaducer orifice, heating-up > 4¢ T, ef » a : a2 Temperature |< 3 Test Vetfion: Tenperatwe. transducer rife: nifemiy: < + 3 empty Pressure | Negative preset punp-0.05Mpa, tine < 30 nie005Mpa pressure maintining, hour» variation in_>rssure 0ikpum D.1Kpafain i in (2.0sMpu, presue mnnaining 1 hour» vrinton in psu | .02Kpamn 75% {Good pearance, the formation of clan, uniform col, om bu, Appsarance | marked chr, accut and slid; ‘onto leible and efeive baton General | Posumaic roromar | rece [mma Cl shoud bere confor oie | 75am oor Documents Re megs complete conf “Tete a it “Feating pesto ang Bing Wor Short HangingMaintenance schedules Maintenance ittings Name tho Time | Fittings w eee Method oor set Latscaton ‘3 en pent oor cinder | Labeaton fe ene of oaiy_ | Weitrmpeetst mete | Kear fat Haienarce | rv inspodanking Tighten. cena sing ng “rot vate tnopect taking ‘Ton change Sel tg Rostcing ve ‘Won redced pressure vaue | Aah —— Remove door seal, clear groove weit [BESO eet, | Remon at Remove corsa lear 0 maintenance | (Pas) Ipet Ast enghe oad ol mt (ibis tite pars) : ‘Pump air storage a coer) ‘At pup craks ol se | Low of al ine Gee own | Relrvave ofr pump” | Deponsasy ae ee ‘maintenance | EO nozzles tray ofinner | pig Cleaning det ad Dirt block Cleaning fownetor ickng Relatvaieatchanbor | sofey Send penetra emt ratte Teper rananiter | Helen nspecton Sendlomemararert nets Prestreonaavce "| Meter epocton Send tomensrement tte ’ Fmt raesocer | Matty poston Sent x Vacuum pum Boating fel ean _ mee | Vacuum pump ‘Impeller cabinet has sundries ‘unpick and wash, cleaning Wr pan Aochrcal sain in Repace Iner cba Siiace cing oot Inderal clearing Scster bectnn Sreei i i i i 0 i i q ] i l ! | | Common fault and Solve list Fault Reasons Solve method “Sequence of vacuum pump.vacuum valves | According tothe operation instucons sue are rong ‘Cabinet ponding | Inet valve of vacuum pump fare Repair or replace Ilon when add water or Humiyg | Inspect team source, Coto excessive humivine casas ‘oor seal broken Replace door sea ‘Door seal grove has sundries Remove Cabinet leaking gos | Door seal stip lack of heaton ‘Addo Rebet va fatre Inspection maintrance Some vavespping leaking Retgnon or epee Low pressure of air source Inspect alr presse Door seal cannt be inhatation hore, Open door taro | Cock aghion ‘According tthe o2eraton instructions Aretha dor was unlocked haa reloce ‘Thro valve Yate Low pressure ofa souroa Inepect at prseune Door seal cant be inhalation Innotaton Closed tate ae. Lock tighten Lock ose Thro vale fale ‘Adjust replace Don't start vacuum pump ‘Stat the vacuum pump Door sea canntbe | suction ve of door eas are Raver ap rhelaton| Into valve of door seal fle Repay rebiace Door sea groove has sundry erful ean | Remove sundry, add of Door unclosed exactly Idenuty causes Door seaisinfatable | Clove to smth fre Adjust or Replace fare Unik the door Lock Door sea filing valves flue Repair or Replace or cyinder leaking | Seaing ting damaged Replace Poorevlnder leaking / Cynder ont loose Tighten Replace ‘Vacuum pump Circuit breaker overloas -_ tema lay proto Pump working cures to large, Inoperaton Thermal relay protection amp wokinggq ieee Check ho water Yaauun pap ‘Unopened vacuum values pen vacuum ve bora oie Impotency hs suncies Remove suns ‘Asbestc col rope damaged Replace ‘Vacuum purp leaking | Abst co op Tiaten ange \Vacuumize to slow or | Hydropenia or smaller flow water pump Water leakage Foplace the sealing rina iret breaker overload Replaco ‘Water pup inoperation | Thermal relay protection Pump working curentis oo large, Iaentiying Causes, Check vacuum inflow water pect esking ow gator tomparatire voce Clot etn cs ta etn Ips ira Arpmo wating | Sa ge Sed sada —— Door cylinder seal has problem Inspection Contre droge Cantiete0 | ovenfonnen tenguatae 0 anche eration According Io the operation instructions Temperature dsplay | Probe damaged Replace wrong ‘Signal output faut denatying Causes Change temperature PLC output fut Foplacoment themrometer incontotable \Wrony parameters sot ‘According to the operation instuctions ry tompersiure control head hysropenia | Add water ‘ig humiaty enor | purty contol head damages Replace Sora cope ou enka Cases change Pressure transmiter damaged Repair or replace, Pressure display wrong | pressure gauge output fault Identifying Gauses change Instuments are not | Instrument proteton circuit breaker er (ee jrabsn entiying Causes,chang ——————EePIPE MARKS LIST _ = Hot water pipe 7 Orange + [eeasasees ee cxeen 6 Compressed air pipe | ve110w | 8 Vent pipe Blue [2s ge ampee, comm ToeHangzhou Shensheng Steriizer Equipment Co. Ld Ethylene oxide sterilization knowledge comprehensive test, ‘Company: Name: Age: ‘Attontion: supply one copy ID and two pes # inch bareheaded white groune photo to get steriizer operation license. 41, Sentence Completion Total 30 score.each case 2 score) co wl happen chemical reaction with microbial protein during EO sterilization result in microbial death, (2, The stelizer working process is very complicated process conto, Il cause the sterilization disqualification even cause catastrophic consequences if Stelzer improper ‘operation. So the operators should have high responsibilty abidance by (©, The EO sterilizer was consis of stetlizer chamber, @, Stetlizer equipment structure was consist of . vacuum systom, 4 corresponding control system. (©, Below 5 parameters affect the stelizaton effect arecty, and sterilization time. (@,1found purmps and sterilization parameters are abnormal during sterilzaton process, should Inform timely and record the maintenance, ©, Ethylene oxide have certain toxicity human body suction too much one tine have Aiscomfor feelingeven appear headache, vomiting, efc_____phenomenon. It human skin.eyes, ete contact ethylene oxide,should flushing by timely, serious seek medical attention immediately 2, True or False yes" filed “ *, "wrong" filled "total 40 score,each case 4score) (D, The sterizton effect was relative to sterlizer chamber inside temperature pressure, humidity and EO concentration. To get best sterilization efleccan shorten steilization time when these parameters were set on appropriate numerical «) ©, Ethylene oxide sterlizer application Is very wide, the most commonly sterilization for ‘medical supplies medical equipmentynedical and cultural products an bis a products, cay (, The sterilization effect was depend on striization parameters onyi’s uncancemed vith sterilization goods packaging, loading methods and materals.ete other factors...) (®, Steriization completed hard pry is enough ifsteriizer doors cannt be open do not need toeliminate reasons. 4) (©, For the EO injection process. the operators just_ put the EO injection swite to the raeHangzhou Shensheng Steriizer Equipment Co. Lt ‘appropriate poston, dont need fo whole process monitoring. cee) (©, According to the domestic and foreign relevant data, EO sterilization eonition as below, temperature:30~600, EO gas concentration:250~1200mgl,humicily:30-B5%RH, pre-vacuum pressure:-15KPa~80KPa, sterilzation time-4~12hours () (®), The operator make below workings in sterlizer room are no lect the steriization during sterlization processor example, electric welding gas cutting dismarting electric Wire,remove strike object and so on, (oy (®, find vaporizer blocking when sterlization process it should dismounting vaporizer and flushing vaporizer inner tube by hot water until there is no foreign body out. an) (©, Do not need equipment maintenance as long as striizer can normal operation...) (0, The operators should check as below step when sterilizer leakage.the specific practice 's inject relative pressure +50Kpa compressed air to steilzer inside chamber, wipe and leak finding by soap water or essence water. al 3, Short answer (Total 30 score) 4. In sterilizer operating programplease sketch out the operator should make what's preparation work before loading (7 score) 2, Please sketch out what's measures should be taken when the leakage happened on EO Injection. How to leak finding and maintenance (8 score) according tothe strilzaion process(@ score) 4, Please sketch out the maintenance have any significance for sterilizer equisment normal ‘operation(please write at back thanks).(7 score) 2.Peae aie wat’ our stars man ccleaner Super aeverHake co ee 4 Ethylene Oxide Sterilizer oS ine te ou Product Certificate aad FSX RAZA Product Name __|“HSX" Ethylene Oxide Sterilizer nia Renee TRL Manufacturer Hangzhou Shensheng Steiizatvn Eyuipment Co, Lid rua Productmodet__| HS%0 | Pa Prout Code i Pale EE, EW STEAL 3R0V 5002: Hs TERW | Speciation Voliage: AC Three-phase iveswire _380V SOHIZ; power: 8KW PMR | BR OST HA ALA TL Classification of | The second category 6857 disinfection and sterilization equipment and Medical Devices | apparatus Hm Fiction dts etal | zoids BERT ISOTT33 FE “This sterilizer execution 6011135 Standard. SIRE MAST, APATITE, BORIC ATR RR ARDMORE MRS fe HERAT ‘This sterilizer is complied with drawing, technic document andthe request of safe rule. It is tested tobe qualified, allowed 0 sel an | (YS ane are REM Issue company DE, AREOLA AA, RE ER Remarks: This certificate is just suitable o 16-20F. safekeeping Ifyou lost, we will not supply it agin.¢ SCSI a g 3 g $ pysewe TE ‘Ves SHYSUER eT Aarne Ag B evebereazeue B =z TR RESEACECNESES FRESE (peaentoreseseneneneaefA Be ATES HART spc Mab H.20152570120 ne ea Bu ASA A ATA appara an eaar ALP emanate [aisKe25. SX AKRHR LRHE ee HSX-15. HSX-10. WSX-6. A1B%-3~ WSXH1, WSK ‘ anh he Beene ats BRR. EVRMRAE PeRET LE aaeen eee LR FRRRERitis URES TSSSS SE ts ee SG a wevwonastoe swe Wie RUPEE USMS Bas F ecw RRA a LS amxyyememagee TE WE VROTT B evagereuseny 82% Vets YEMEE * gycrroctocs fa mE % Pree re Bue BY + TGSEt wt 308. ee a er = ERGEDRIEILRETRSUS (Aww : pone MudaasaaNanimeHe | |e