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XG2.C Series

Ethylene Oxide Sterilizer

Users Manual

Shandong Shinva Medical nstru!ent Co." #td.

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Thank you for your purchasing our Companys ethylene oxide sterilizer. To bring the best capabilities of the sterilizer into play, please read this User s Manual carefully before using this sterilizer, and install, use and operate it strictly according to the requirements described in this Manual in order to ensure that this sterilizer serves you safely and reliably. This Manual is applicable for installation, operation and maintenance of !".C series ethylene oxide sterilizers.

Our Co!)anys ethylene oxide sterilizers con*or! to the *ollo+ing related standards and regulations,

Medical device Manu*acturing Enter)rise #icense -o,

#.GXSCX -o. 2'1'''24

-o. o* hygiene license *or )roduction enter)rise,

#/X00 12''$2 -o. '234

-o. o* registration certi*icate *or !edical device

#S.5X1020 12''32 -o. 267'277

8roduct standard
.09:# '2$3%2''3.

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Content
I. WARNINGS AND PRECAUTIONS.................................................................5
# $recautions..............................................................................................................................................% ". &afety symbols.......................................................................................................................................' (. Contact Us..............................................................................................................................................)

II. INTRODUCTION TO ETHYLENE OXIDE GAS............................................8

#. $hysical * chemical properties of ethylene oxide.................................................................................) ". +luminum,canned ethylene oxide.........................................................................................................(. .eak and its emergency treatment of the ethylene oxide gas /ar.........................................................#0

III. THE PRINCIPLE OF ETHYLENE OXIDE STERILIZATION.......................11

#. 1undamentals of the ethylene oxide sterilization.................................................................................## ". Characteristics of the ethylene oxide sterilization...............................................................................## (. &cope of the ethylene oxide sterilization application..........................................................................#" 2. Characteristics of !".C series ethylene oxide sterilizers..................................................................#" #. &pecifications of the sterilizer..............................................................................................................#2

V. DEVICE INSTALLATION.............................................................................14
#. 1ield installation requirements.............................................................................................................#2 ". 3nstallation process, method and precautions......................................................................................#% #. Main body............................................................................................................................................#". &eal door .............................................................................................................................................#(. $ipeline system ..................................................................................................................................."0 2. &tructure and principle of control system............................................................................................"# %. 4perating principle of the control system............................................................................................"" 5. &terilization basket .............................................................................................................................."" #. $reparation 6ork before the use of ne6 device..................................................................................."2 ". $reheating temperature selection........................................................................................................."%
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(. 4pening and closing of the door.........................................................................................................."% 2. 7un a program......................................................................................................................................"5 %. &ystem setting......................................................................................................................................"' 5. (' program heating 6all temperature setting..................................................................................") '. %% program heating 6all temperature setting.................................................................................."). Temperature rise speed setting.............................................................................................................(0 -. 8acuum speed setting...........................................................................................................................(0 #0. &ystem time setting............................................................................................................................(# ##. $rinter setting.....................................................................................................................................(" #". &ystem parameters setting..................................................................................................................(" #(. Treatment of goods to be sterilized and precautions..........................................................................(2 #2. $recautions before starting the sterilization cycle.............................................................................(2

VIII. MAINTENANCE AND REPAIR.................................................................36

#. Manual operation.................................................................................................................................(5 ". 3nput check...........................................................................................................................................(' (. 7estore to factory setting.....................................................................................................................(' 2. 9dit program .......................................................................................................................................() %. +larm processing.................................................................................................................................20 5. Common troubleshooting.....................................................................................................................2# #. &elf,protection......................................................................................................................................2( ". &terilization quality assurance.............................................................................................................2( (. 9xamination of sterilization effect.......................................................................................................22 2. 9nergy,saving and environmental protection......................................................................................2% #. 4perating procedures...........................................................................................................................25 ;Shinva< =rand ethylene oxide sterilizer o)erating )rocedures...........................................................44 ". +ttached technical dra6ings................................................................................................................25 &ttached >igure 1, Structural diagra! o* the device............................................................................44
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&ttached >igure2 ,8? @ diagra!...........................................................................................................44 &ttached >igure $,XG2.@C0%1$' installation diagra!........................................................................44 &ttached >igure 4,XG2.@CA%22' installation diagra!.........................................................................44 &ttached >igure 6,/iring diagra!.........................................................................................................44 &ttached >igure 4,/iring diagra!.........................................................................................................44 &ttached >igure 7,8o+er su))ly sche!atic diagra! ..........................................................................44 &ttached >igure 3,8o+er su))ly sche!atic diagra! ........................................................................44

&ttached >igure B,Che!ical *illing valve ..............................................................................................44 &ttached >igure 1',Electric drive )usher control circuit diagra! .....................................................44 &ttached >igure 11,Electric heater =and control circuit diagra! .......................................................44 &ttached >igure 12,Aacuu! )u!) control sche!atic diagra! ..........................................................44 &ttached >igure 1$,&nalog in)ut sche!atic diagra! ..........................................................................44 &ttached >igure 14,@igital in)ut out)ut sche!atic diagra! ..............................................................44 &ttached >igure 16,@igital in)ut out)ut sche!atic diagra! ..............................................................44 &ttached >igure 14,&ir co!)ressor control circuit diagra!................................................................44

. /arnings and 8recautions

The follo6ing safety precautionary statements shall be follo6ed 6hen operating and maintaining this sterilizer. These precautionary statements :partly or full; 6ill be available throughout this Manual. +ll safety precautions 6hich 6ill appear in this Manual are listed belo6. 1 8recautions $lease read the follo6ing contents carefully before the use or maintenance of this sterilizer. 3n this Manual, if any of the follo6ing symbols is used, it illustrates that the operating content shall be paid 6ith more attention or highly regarded. -otic e sterilizer. @ange rous /a ring

indicates that the contents shall be highly regarded.

indicates that these instructions shall be follo6ed, other6ise it may result in damage of the

indicates that these instructions shall be strictly follo6ed, other6ise it may endanger the personal safety.
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<efore operating this sterilizer, please remember the follo6ing precautions= -otic e

>hen the symbol is found at any position of this sterilizer, the Manual and other related documents shall be read in order to make clear the nature of potential danger and those measures 6hich must be taken. -otic e -otic e location. @ange rous

3n any case, nobody tears do6n or takes out any content from the Manual. 3f there is any inconformity 6ith the User?s Manual or there is any condition 6hich isn?t described in this Manual, please contact the manufacturer in time in order to upgrade or update it.

This Manual shall be stored in a 6ell,ventilated, dry, moist,proof and high,temperature

This sterilizer uses the ethylene oxide gas as the sterilization medium. The ethylene oxide gas is inflammable, explosive and moderately toxic, and no operation of the sterilizer is allo6ed if the operator doesn?t pass the qualified training.

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<efore using this sterilizer for sterilizing, carefully check the safety data sheet for chemical products provided by 94 gas manufacturer, and consult the medical device manufacturer in order to ensure that the ethylene oxide sterilization is applicable for the goods, other6ise it results in the unpredictable consequences@ -otic e

To make the device operate safely and reliably, apart from the routine maintenance 6hich is described in this Manual and shall be persisted, the preventive maintenance also shall be periodically done. /ar ings This device must be maintained and ad/usted by the qualified professional maintenance personnel. +ny unconventionalAnon,routine maintenance done by the inexperienced and unqualified maintenance personnel, or installation of unauthorized parts may result the personal in/ury. @ange rous <efore maintenance, disconnect all 6ater and electricity supplies from this device. Bo maintenance can be done unless all 6ater and electricity supplies are disconnected 6ith proper methods. 2. Sa*ety sy!=ols The safety symbols to be used 6ith the device are specifically defined as follo6s= Caution, consult accompanying documents 3&4 ()52, Bo. <. (. # Caution, risk of electric shock 3&4 ()52, Bo.<. (. 5 9arth :ground; T97M3B+. 3 9 C 2#', Bo.%0#' $74T9CT389 C4BCUCT47 T97M3B+. :!74UBC; 39C 2#', Bo. %0#+lternating current 39C 2#', Bo.%0(" Caution, hot surface 39C 2#', Bo.%02# Consult instructions for use DD 0255, Bo.(.( Caution, risk of electric shock
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E99$ +>+D 174M 7+3B DD 0255, Bo.(.)

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39C 2#', Bo.%0(5

1use 3 9 C 2#', Bo.%0#5

This >ay Up !<AT #'# Bo.(

&ling Fere !<AT #'# Bo.#5

$. Contact Us Cel 1342'6$$%$6B1214 $631217 >ax 1342'6$$%$6344'B Code 266'34 /e=site +++.shinva.co! +ddress= &hinva Medical &cientific Gone, Gibo Be6 * Fi,Tech 3ndustrial Cevelopment Gone, Gibo City, &handong $rovince, $.7.China

. ntroduction to Ethylene Oxide Gas

1. 8hysical ? che!ical )ro)erties o* ethylene oxide 9thylene 4xide :abbreviated 94; is a simple epoxy compound, 6ith the molecular formula of C"F24. The 94 liquid is colourless and transparent, 6ith fragrant smell ether. The ethylene oxide is moderately toxic, and 94?s specific gravity is 0.))2 :the specific gravity of 6ater is #; at 2 , its boiling point is #0.' , and its density is #.%" :the density of air is #;. 94 can be soluble in 6ater at any proportion and then forms the ethylene glycol. The ethylene oxide is inflammable and explosive. >hen in the air contains (H ethylene oxide, it generates the explosive gas mixture 6hich may result the burning or explosion if it catches the fire. /ar ings

9thylene oxide sterilizer and gas /ar shall be absolutely far a6ay from the flame and fire sources, such as match, cigarette end and other electrical locations 6here the static electricity and spark easily appear or flash. The ethylene oxide is moderately toxic, and the acute or chronic inhalation of a ma/ority of ethylene oxide and the eye, skin and alimentary canal contact 6ith ethylene oxide 6ill seriously endanger the human body. The ethylene oxide sterilizer used in hospital mainly has the possibility of chronic poisoning. The 4ccupational Fealth and &afety +dministration :4F&+; stipulates that T>+ and $9. :$ermissible 9xposure .evel; I #ppm, +. :+ction .evel; I 0. % ppm, #% min sampling contactI % ppmJ and if the concentration of 94 in the environment is less than +., the routine environmental concentration inspection is unnecessary or reduced. The Technical &tandard for Cisinfection formulated by the Ministry of Fealth of the $eople?s 7epublic of China defines that the 6orking environment shall be 6ell,ventilated. Curing )h 6orking every day, the concentration of 94 in the air in the sterilization environment shall be less than #.)" mgAm(, and the exposure concentration 6ithin #% min 6orking shall be no more than -.#0 mgAm(.

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94 gas poisoning emergency treatment table $oisoning Method +cute inhalation Chronic inhalation 9ye contact &kin contact $oisoning &ymptom 7espiratory tract irritation, dizziness, 6eakness, vertigo, sickness, and neurotoxicity symptoms &uspicious carcinogenesis, teratogenesis &erious eye irritation and in/ury .iquid,state ethylene oxide causes the skin irritation, dermatitis and blister &erious irritation and burning of the mucous membrane of alimentary canal 3mmediately 6ash the eyes for at least #0 minutes, and then immediately see a doctor 3mmediately 6ash the skins for at least #0 minutes, take off the contaminated clothes and 6ash it 6ith soapy 6ater, and then see a doctor quickly as possible 3mmediately inform the doctor or local $oison Control Center, and actively induce the sickness after drinking 6ater. Fo6ever, for the patient 6ith dottiness, no induction of sickness or feeding of any food is allo6ed 9mergency Treatment

3mmediately inhale the fresh air, quickly get to hospital or see a doctor

+limentary canal contact

2. &lu!inu!%canned ethylene oxide The boiling point of the ethylene oxide is very lo6 :#0.' ;, and it is very easily gasified at the room temperature. &o, the ethylene oxide must be stored in a sealed container 6hich can bear a certain pressure. Bo6adays, the commonly,used container includes the ampoule, steel bottle and aluminum /ar. This series ethylene oxide sterilizers use small special quantified aluminum /ar to contain the pure ethylene oxide gas, 6hich is also called Khigh,purity 94 sterilantL, and one /ar of gas 6ill be consumed every a sterilization cycle. To ensure the necessary sterilization concentration, these sterilizers of different volumes shall equip 6ith the ethylene oxide gas /ars of different 6eight specifications. 7efer to the table belo6 6hile selection= 94 gas /ar parameters Model &terilizer Model !".CCG,#(0 !".CC8,""0 G,#00 8,#'0

>eight of the ethylene oxide contained #00g #'0g

The ethylene oxide gas /ars shall be stored in a specified cool and 6ell,ventilated location, and the storage environment temperature shall be controlled belo6 (0 J and the ethylene oxide shall be far a6ay from the strong acid, strong base, strong oxidant, ferric chloride, aluminumr chloride, stannic chloride, base metal and other inhibited substances, and the high heat, smoke and fire is strictly prohibited.

The gas /ar shall be absolutely far a6ay from the flame and fire sources, such as match, cigarette end and other electrical locations 6here the static electricity and spark easily appear or flash.

/ar ings

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$. #eaD and its e!ergency treat!ent o* the ethylene oxide gas Ear 3f any of follo6ing phenomena appears, it indicates that the ethylene oxide has already leaked from the gas /ar. The liquid,state ethylene oxide leaks quickly from the gas /ar. 3f you touch the gas /ar by hand, its temperature considerably decreases. The 6eight of the ethylene oxide gas /ar decreases.

3f the burning is found, the 6ater spraying, foam, carbon disulfide, dry,po6der fire, extinguishing agent can be used for firefightingJ if the leak can?t be stopped timely, let it burns and remove the container from the fire scene.

-oti ce -oti ce

$lease use the ethylene oxide gas covered by the 6arranty.

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. Che )rinci)le o* ethylene oxide sterilization

1. >unda!entals o* the ethylene oxide sterilization 94 can kill all kinds of microorganisms, including the bacteria propagule, spore, virus and fungal spore, and is a broad,spectrum sterilant. 3t is generally stated that it can take the non,specific alkylation function 6ith the microorganism?s protein, CB+ and 7B+. The ethylene oxide can suppress the activity of some microbialenzymes, including the phosphoric acid activation enzyme, peptidase, gallbladder alkalization enzyme and cholinesterase. 2. Characteristics o* the ethylene oxide sterilization F /ide sterilization s)ectru!, 3t is the chemical sterilant 6ith best sterilization effect, and can kill all kinds of microorganisms, virus, spore, bacteria, propagule and so on. F #o+%te!)erature sterilization, The selected sterilization temperature is relatively lo6 to (' or %%, 6hich prevents the high, temperature oxidation of the goods. F Strong )enetration )o+er, 3t can penetrate the package micro,pores and get to the deep portion of the goods, and thus fulfill the sterilization 6ith package and extend the storage time of the goods at germ,free condition. M Bon,oxidation, and non,corrosion= 3n general, the ethylene oxide doesn?t corrode metal, plastics, rubber and other similar materials, and thus result small damage of the goods. &ince 94 kills the microorganisms by using the alkylation principle other than non,oxidation process, it results very small damage of the goods and has very 6ide application for the sterilization of heat,sensitive precision instruments. F Aarious e**ect exa!ination !ethods, There are biological examination indicator, chemical examination indicator card, chemical examination indicator adhesive tape and other examination methods, 6hich can effectively examine the sterilization parameters and sterilization effect. F /ide su=stitution, The ethylene oxide can be applicable for sterilization of those goods 6hich can?t be sterilized 6ith the sterilant soaking, dry heat, pressure steam and other chemical gases. M >ide range of packing materials applied >hen sterilization, the requirement on the packing material is lo6, and a ma/ority of general packing materials can be used for packing the sterilizer. F (ich ex)erience in use &ince #-%0s, 94 has been used for sterilization in hospital, 6ith near 50 years of experience in use. The ethylene oxide is kno6n as a very effective lo6,temperature sterilization method and 6idely applied in medical, health, foreign trade, commercial, bank, archaeology, archives, cultural relic administration and other departments, and in particular, for those heat,sensitive, humidity,sensitive and corrosion, sensitive goods, the ethylene oxide sterilization sho6s its unique advantages even more. +lthough the ethylene oxide sterilization has many advantages, it also has some disadvantages. The ethylene oxide sterilization is inapplicable for the liquid,state goods. The ethylene oxide sterilization is inapplicable for the goods and equipment 6hich have the potential inflammability. The ethylene oxide sterilization is generally inapplicable for foods and a ma/ority of medicines. The sterilization effect of compact po6dery goods is difficultly guaranteed. The sterilization time is relatively long.

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$. Sco)e o* the ethylene oxide sterilization a))lication

<efore using this sterilizer for sterilizing, carefully check the safety data sheet for chemical products provided by 94 gas manufacturer, and consult the medical device manufacturer in order to ensure that the ethylene oxide sterilization is applicable for the goods, other6ise it results in the unpredictable consequences@ 94 is 6idely applied in clinical care, and the devices and instruments 6hich are commonly used for 94 sterilization include= :#; 7igid and flexible endoscopes= +rthroscopy, bronchoscope, cystoscope, gastroscope, enteroscope, mediastinoscope, ophthalmofundoscope, otoscope, pharyngoscope, proctoscope, resectoscope, thoracoscope, urethroscope. :"; Medical device= +nesthesia device, artificial kidney, diathermy device, electric 6ire, gauge header, heart,lung machine, respiration, treatment device, hemodialysis. :(; 3nstruments= 9lectrodrill, electric heater, electric knife pen, tooth drill, microsurgery instruments, nerve stimulator, manometer, surgical operating instruments, bone drill, needle, artificial /oint. :2; 7ubber products= Conduit, dilator, rubber drainage tube, endotrachael intubation, surgical glove, bed sheet. :%; $lastic products= air6ay intubation, dilator, endotrachael intubation glove, pacemaker, heart valve, sprayer, culture dish, syringe. :5; 4ther= 1iliform, bougie, thermometer, surgical sutures. 4. Characteristics o* XG2.C series ethylene oxide sterilizers !".C series ethylene oxide sterilizer uses the pure 94 gas as sterilant, 6hich features advanced design, reasonable structure and stable performance. The sterilizer uses the programmable controller to fully control the 6hole sterilization process, and has the medicine control, temperature control, time control, humidity control, goods ventilation treatment and other functions, 6hich ensures the reliable sterilization effect and minimizes the possibility of contact of the ethylene oxide by the operator. 12 >ull auto!atic control o* sterilization )rocess, The sterilizer has t6o operation procedures= (' and %%. The operator selects (' or %% procedure only according to the heat resistance performance of the goods to be sterilized, and considers the quantity of the ethylene oxide absorbed by the goods and other factors and then set the corresponding ventilation time. Then, the operator slightly touch the &T+7T button, the control system can fulfill the full process running, and he can monitor real,time the generation of unusual signal until the sterilization cycling process finishes. G Uni*or! sterilization concentration, The quantified small,packing special pure 94 gas /ars are used, and the contained ethylene oxide is stable in quality, 6ith the effective constituent of --H or higher :executive standard !<#(0-);. The application of pure ethylene oxide ensures the concentration level of 94 gas inside the sterilization chamber and overcomes the stratification of the ethylene oxide gas mixture and sterilizer gas, non, uniformity of concentration and other defects. The sterilization concentration can be reflected 6ith the change of pressure inside the sterilization chamber. G Sta=le sterilization te!)erature, The fuzzy control technology is used to monitor the temperature of sterilization chamber in full process, and control the temperature deviation at the sterilization stage 6ithin the range of N( of the required value at set point. The sterilization temperature can be real,time displayed on a .CC display. G &ccurate and continuous sterilization ti!e, The precise time set inside a programmable logic controller :$.C; is used, 6hich deletes the man,made interference factors and ensures the full exposure time in the sterilization process. +t the sterilization
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stage, the po6er,off memory function is available, 6ith the continuous and reliable sterilization time. The sterilization time can be real,time displayed on a .CC display. G E**ective sterilization hu!idity control, Multiple times of pulse humidifying and penetration under the vacuum condition are used to uniformly increase the level of humidity inside sterilization chamber. +nd in the sterilization chamber a humidity sensor is set in order to automatically examine the relative humidity inside the chamber and thus make it get the accurate control. 22 Sterilization o)eration sa*ety control, O The full,process negative,pressure sterilization technique is used to cut off the possibility of leakage of the ethylene oxide gas. The control system has the vacuum examination procedure and vacuum guarantee procedure, and automatically keep the pressure inside the sterilization chamber at the shallo6 vacuum state if the vacuum leak and other abnormal conditions are found, and no dispersion of the ethylene oxide gas is guaranteed during operation. O The special control circuit is used to ensure that the ethylene oxide gas /ar successfully penetrate only under the sterilization chamber deep vacuum condition, and the effectively,controlled position inspection is introduced to ensure the safety of installation of the ethylene oxide gas /ar. O Multistage interlock control is used, and the sterilizer enters into the sterilization process only after the seal door is closed. +nd, the seal door is fully locked at the sterilization stage in order to effectively prevent the possibility of occurrence of misoperation. $2 @yna!ic dis)lay o* sterilization )rocess, + special blue or full color .CC display is used as the operating screen, and has the touch button 6hich can be used to fulfill the manual startup, selection of the procedures, ventilation time setting, emergency stop and reset, if necessary, and other functions. 4n the .CC display can real,time display the current pressure, temperature or pre,treatment humidity in the sterilization chamber, and also display the status of seal door, sterilization cycling process menu and its current stage, and the completed sterilization time or ventilation time. 3f any abnormal signal is found, on the display 6ill display the flashing of related alarm code, and reminders the operator to remove the trouble. 42 (eal%ti!e )rintout o* sterilization )rocess, The sterilizer has the built,in high,resolution thermal printer system. Curing the sterilization cycling process, the system 6ill automatically print out the pressure, temperature and humidity vs time curves of this cycle, 6hich can be provided to the operator for storing or future reference. 62 (eal%ti!e !e!ory o* sterilization )rocess, +n unique memory module is used, and the control system 6ill automatically memorize the current sterilization information if po6er,off. +fter po6er on again, the sterilizer continuously 6orks, 6ithout re, startup, 6hich 6ill save the sterilization consumption and improve the efficiency of sterilization operation.

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A. Cechnical 8ara!eters
1. S)eci*ications o* the sterilizer
4rder Bo. Technical parameters &ize of sterilization chamber :.x>xF; mm 8olume of sterilization chamber . Cimensions :.x>xF; mm $ackage size :.x>xF;mm Bet 6eight Eg $o6er +C""0A%0Fz &terilization temperature 9thylene oxide gasAcycle Cistilled 6aterAcycle !".CCG,#(0 '%0x2%0x200 #(% -%0x)50x#'(0 #0%0x-50x#-00 (00 (E6 (' and %% #00g "0 , (0ml !".CC8,""0 #"%0x2%0x200 ""% #2%0x)50x#'(0 #%%0x-50x#-00 200 2E6 (' and %% #'0g (0 , 20ml

A. @evice nstallation
1. >ield installation reHuire!ents 12. Environ!ental reHuire!ent, 9nvironmental temperature= % , 20 7elative humidity :7.F.;= P)%H +tmospheric pressure= '0k$a , #0%k$a 22. Energy source reHuire!ent, $o6er= +C ""0 8N""8, %0FGN#FG Compressed air= %0 .Amin $2. Custo!erIs air exhaust duct, O The air exhaust duct shall be connected to the outdoor through an individual sealed conduit, and there is no inflammable and explosive substances, people, 6indo6 and other air inlets in the area of )m diameter around the terminal of the air exhaust duct. O The air exhaust duct shall be unobstructed and fully smooth, no back pressure shall be applied onto the outlet of sterilizer, and the orifice of top outlet reverses do6n6ards in order to prevent the moisture leaving in the duct 6all or resulted clogging of the 6all. O The materials of air exhaust duct and accessories must have adequate endurance on the ethylene oxide gas and exhaust pressure, and no generation of the harmful substances is allo6ed. The "%mm 3.C. copper tube or "5mm 3.C. * ("mm 4.C. polyethylene,aluminum composite tube is used. O The length of air exhaust duct shall be no more than -0m, and the horizontal piping shall be reduced as
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possible, and the elbo6 shall be reduced as possible. 3f the length of duct exceeds -0m, the diameter of the duct must be increased. O >hen the length of air exhaust duct is less than (0m, and the inside diameter shall be at least "0mm, and if the length is more than (0m, the inside diameter shall be at least "%mm. O >hen the vertical segment of the air exhaust duct exceeds (m, a 6ater collector must be additionally installed. O >hen the length of air exhaust duct is more than (0m, another air exhaust duct shall be reserved for emergency exhaust use 6hile the main duct is clogged. O The air exhaust duct shall have no dent or turning circle 6hich may result in the 6ater vapor gathering and even the freezing in 6inter. O >hen the environmental temperature at air exhaust duct is less than % , the effective heat insulation measures shall be added to the duct. 42. @evice installation s)ace reHuire!ent a. The device shall be placed in an individual sterilization room in order to ensure the operation safety. b. Cevice installation space shall set apart the maintenance and operation spaces. The distance bet6een the right and left sides of sterilizer and 6all shall be no less than 0.%mJ the distance bet6een the rear end and 6all shall be no less than 0.%m 6hile installing a single sterilizerJ and the distance bet6een the sterilizer?s front and rear operation panels and the opposite 6all or pallet shall at least reserve #.% times of the overall length of the device in order to conveniently open and close the door and ensure that the sterilization basket can freely enter into and exit from the sterilization chamber. 62. (oo! ventilation reHuire!ent The 6ell,ventilated room 6here the ethylene oxide sterilizer is installed is required, 6ith #0 times of air exchange capacity every hour. 3f the requirement is unavailable, the appropriate exhaust fan and ventilation system must be additionally installed. 42. Sterilization gas storage reHuire!ent a. The storage and use of sterilization gas shall conform to Regulations on the Control over Safety of Dangerous Chemicals and other related regulations and standards.

ntilated warehouse. It shall be far away from the fire source, spark, and heat source, without exposure to direct sunlight. The temperature of warehouse shall be no more than 30 . The storage of gas shall be separated from the acid, base, alcohol and food chemicals, and the mixed storage is prohibited. The explosion proof lighting, !entilation facilities are used. "o mechanical de!ice and tool which can easily produce spark are used. In the storage area the leak emergency treatment de!ices shall be pro!ided.
b. The sterilization gas shall be stored in a cool, 6ell,ve 2. nstallation )rocess" !ethod and )recautions
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a. Un)acD Che )acDing case !ust =e al+ays )laced u)+ards" and !ore attention is )aid not to da!age the device +hile un)acDing. #Check 6hether the packing is intact before unpacking. "Unpack the device after it is placed in a flat space :minimum space requirement= % mQ% m;. ( 3nsert the lifter arm from the left,hand or right,hand bottom of the device, 6hich the depth must be adequate, and extend the arm about "00 mm at the other side of the device :please refer to R1ig. #S;. Carefully hoist the device "00 mm from the ground. >hen the lifter arm is inserted into the bottom of the device and the device is removed, note that no static discharge is produced. 2 $lace the sterilizer onto the level ground, turn the nuts of horizontal ad/usting leg in the clock6ise direction, and hoist the fixed pad. Move the device 6ith the caster 6heels. % +fter the completion of installation, turn the nuts of horizontal ad/usting leg in the anticlock6ise direction, and lo6er the fixed pad. :Make the fixed pad fully contact the surface in order to prevent the movement of the device during operation process;.

Landle the device, * necessary" trans*er the device +ith a trolley *ro! the un)acDing site to the installation site" +hich shall =e done =y t+o )ersons. /hen handling the device" =e care*ul not to *orci=ly )ush the *ront )anel and control )anel.

-otice
.ifter arm

J>ig. 1 K 8osition o* li*ter ar!

-otice
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<ack >hen handling the device, please push the back of the device

Q >hen handling the device, do not forcibly push the front of the device

J>ig. 21 K 8recautions on handling the device

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=. nstall the air exhaust duct 7efer to the device installation diagram, and find out the exhaust outlet. The air outlet of sterilizer is an 7c#A" interface, and located at the rear bottom of the sterilizer. $lease scre6 the 7#A"x7#A" /oint :see the accessories box; into the compressed air connection 6hile installation, and if the installation condition is bad and the connection of pipe is inconvenient, connect the metal hose inside the accessories box in order to easily install the device. c. (e!ove the door )anel su))orting )late To ensure that the components of the product isn?t damaged during the long,distance transportation process, 6e fix all door structures at the bottom of the automatic door 6ith the door panel supporting plate, and thus the door panel supporting plate must be removed before the customer normally operates the device :after removal, store the door panel supporting plate and scre6s;, other6ise the device can?t be po6ered on, and the device can be commissioned and used only after removal of the supporting plate. The specific removal method is as follo6s :tools applied= one flathead scre6driver, t6o M) fork 6rench.;= 7emove the left,hand cover of the device. C4 B4T touch and impact the surface of the outer cover during the removal process in order to prevent the occurrence of any scratch 6hich may affect the appearance of the device. +s sho6n in the figure belo6= 7emove the door panel supporting plate from the left,hand side of the device, and carefully store the removed supporting plate and scre6s for future use. The specific position of the supporting plate is sho6n in the figure above. +fter the successful removal, operate it according to other installation and commissioning instructions@

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A . Structural >eatures and O)erating 8rinci)le

This device consists of main body, seal door, sterilization basket, pipeline system, outer decoration cover, control system and so on. &ee the +ttached 1igure #= Cevice composition dra6ing. 1. Main =ody O The main body is 6ith the rectangular plus reinforcement bar structure, 6hich doesn?t only ensure that the device has enough high pressure,bearing capacity but also improves the spatial utilization rate of the sterilization chamber. O The inner chamber is made of aluminum alloy material and automatically 6elded, and its surface is sub/ect to the mechanical polishing and electrochemical polishing treatment, and bright and smooth, anti, corrosive and durable in use. O The surface of housing of the main body is made of high,quality heat,insulating materials, 6hich isn?t only attractive and durable but also minimizes the thermal radiation of the device and effectively protect the 6orking environment. 2. Seal door The seal door of this series sterilizer mainly consists of door panel, rail, lifting mechanism, door cover, safety interlock system, control components and so on. 1 (e!oval o* seal door >hen the door rolling bearing, electric drive pusher, door obstacle s6itch or door heating tape has fault and needs to be repaired, remove the front outer cover and door cover and then maintain or replace it. 2 @oor s+itch There are t6o door travel s6itches 6hich are limited to the C.4&9 or 4$9B position and installed onto the upper or lo6er of the rail. 3f the travel s6itch at the C.4&9 position isn?t engaged, the program can?t start and run. $ O%ring O &tructure= 4,ring is a specially,processed annular irregularly,shaped silicon rubber ring, and its material composition, shape design, correct installation and maintenance are very important to its normal operation and service lifetime. The 4,ring used by our company uses a specially formulated silicon rubber material, 6hich effectively ensures its stability and reliability under the 6orking condition. O $rinciple= This 4,ring is enchased into the seal groove of front panel of the main body. >hen the seal door is closing, the 4,ring closely adheres to the seal surface of door panel of the seal door, and generates a certain deformation during sealing process and thus fulfills the sealing of the door. O Maintenance= +lthough the long service lifetime of 4,ring is fully considered in the design and material selection, the follo6ing several factors may result the service lifetime of the 4,ring, and these factors shall be avoided as possible in order to ensure the longer lifetime of the 4,ring. a. +fter a cycle finishes, the seal door shall be in 4$9B position, other6ise the 4,ring 6ill be gradually aged because it is pressured for a long time. b.8aseline lubricant shall be regularly :every 6eek; applied onto the surface of the sealing rubber strip. c.Curing use, more attention shall be paid to avoid that the hard ob/ect impacts the 4,ring, other6ise it very easily result in its permanent damage and difficultly implements the reliable sealing of the 4,ring. O 1ailure= 3f any of the follo6ing causes is found, it is basically determined that the 4,ring fails. a.The surface of the 4,ring is obviously hardened, and you may feel the absence of elasticity 6hen pulling and dragging and some netted pull textures are found. b.The 4,ring has cracks or is already broken.

@eter!ining +hether the O%ring *ails or not shall =e co!)rehensively considered" and this is highly related to the long%ter! accu!ulation o* the o)eratorIs ex)eriences in useM
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G CaDe%o** and installation, >hen the 4,ring is required to be taken off, stop running of all programs and then open the door. &lightly break off the outer root segment of the 4,ring 6ith thumbs of both hands, and then take off the 4,ring from the seal groove. >hen installing the 4,ring, place the /oint seam onto the bottom, secure its four corners and then carefully and uniformly press the outer race of the 4,ring into the seal groove along the straight portion of the moulding, alternately press in the inner race of the 4,ring until they closely and uniformly adhere to. 3n this case, you can close the door and the device enters into the operation state. -otice

/hen installing the O%ring" i* there is assistance )rovided =y the other )erson" the installation +ill =eco!e !uch easierM $. 8i)eline syste! This series sterilizer?s pipeline system includes the ethylene oxide pipeline, air pipeline, distilled 6ater pipeline and compressed air pipeline. &ee the +ttached 1igure 2 for the schematic diagram of these pipelines. 12 Che co!)ressed air )i)eline The compressed air pipeline consists of the air compressor, compressed air storage tank, pressure s6itch, solenoid valve and other executor components. This pipeline is used to fulfill the action of the pneumatic valve. O $ressure s6itch= 3t is used to inspect the pressure state of compressed air, and the pressure alarm point is already set after leave factory :0.2Mpa;. 3f the value is required to be ad/usted in particular cases, ad/ust the scre6 on the middle top of the pressure s6itch, and scre6,in it in the clock6ise direction to increase the pressure alarm pointJ on the contrary, scre6,out it in the anticlock6ise direction to lo6er the pressure alarm point. 22 Aacuu! )i)eline This pipeline is used to exhaust the gas inside the sterilization chamber to the air via the side exhaust outlet of sterilization chamber, the pneumatic valve, the one,6ay valve, the vacuum pump and the external pipeline. O 4ne,6ay valve= This valve is a straight,through type check valve, and the exhausting of gas from the sterilization chamber under the program,controlled strong pressure is allo6ed in order to prevent the entrance of the outside air into the sterilization chamber via the vacuum pipeline and removal of vacuum from sterilization chamber, 6hich may affect the service behavior and operation safety of the device. O $neumatic valve= The opening or closing of this valve is controlled by the execution program. 8acuum pump= This pump is an oil,free vacuum pump, and main device for vacuumizing. This pump features small volume, lo6 noise, fast vacuumizing speed, and easy,to,install. $2 Che ethylene oxide gas )i)eline 3f the measured temperature, degree of vacuum inside the sterilization chamber and the condition of seal door are fully normal, the ethylene oxide is released from the built,in gas /ar. The liquid,state ethylene oxide is fully vaporized under the carburetor?s heating function, and then enters into the sterilization chamber. O Carburetor= The carburetor is cuboid,shaped, and has internally the electrical bar and other 6ork parts as 6ell as the labyrinth heating channel, 6hich is used to heat the ethylene oxide, air and distilled 6ater. The carburetor has the temperature sensor 6hich is used to monitor the temperature of carburetor body in order to control the 6ork of electrical bar.

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42 &ir )i)eline The sterilization chamber?s inlet pipeline is located at the left,hand side of the main body. The air passes through the sterilization air filter, and then the solenoid valve, and is heated in the carburetor and finally enters into the sterilization chamber. 3t is used to fulfill the ventilation replacement, and remove the negative pressure of inner chamber at the later stage, ensure that the intake air is in dry and aseptic condition and prevent the possibility of secondary contamination of the sterilized goods. O +ir filter= The filtration accuracy is 0."Tm, and the filter can filtrate the bacteria and foreign materials from the air. The service lifetime of filter element is one year, and it shall be regularly replaced. /arin gs

62 Che distilled +ater )i)eline The distilled 6ater in the 6ater storage tank flo6s through the humidifier pneumatic valve, and is heated in the carburetor and then enters in pulse into the sterilization chamber. &o, the humidity treatment process is completed. O The humidifier pneumatic valve= The valve size is very small, and thus the pureness of the distilled 6ater must be guaranteed in order to ensure the normal operation of the device. C4 B4T use the common tap 6ater as the humidifying 6ater, other6ise it may result the blockage of pipeline. 42 Sensor asse!=ly This series sterilizer equips 6ith the pressure sensor, temperature sensor, humidity sensor and other inspection components, 6hich are used to real,time examine the 6orking condition of the sterilizer. O $ressure sensor= 3t equips 6ith a high precision pressure transmitter system, and converts the sterilization chamber pressure signal to 2 , "0m+ electric current signal 6hich is entered into a $C computer. 4n the display the unit of pressure output is= mbar :millibar;. The related unit conversion is as follo6s= #atmU#0#.(k$aU#.0#(barU#0#(mbarU'50mmFg O Temperature sensor= 3t uses the platinum thermal resistance :$t#00;. $lease refer to the control system for its operating principle. 4n the display the temperature output unit is= :Celsius degree;. 3n the inside and outside of the sterilizer have four temperature sensors, 6hich are used to respectively measure or control sterilizer 6all temperature, sterilization chamber internal temperature and carburetor?s temperature. O Fumidity sensor= The selected humidity,sensitive capacitance component probe is used to measure the relative humidity inside the sterilization chamber. 4. Structure and )rinci)le o* control syste! The control system consists of $C control panel, .CC display, miniprinter, pressure transmitter and so on. O The programmable logic controller :referred to as $.C controller;= The device equips 6ith &iemens &', "00 C$U""5 $.C controller 6hich 6orks according to the preset program, receives and handles all inputAoutput signals, and controls the run of sterilization program. This $.C controller features compact structure, good expansion capability, strong command function, easy installation and use and other characteristics. 3ts 6ork environmental temperature is 0 , %%. 3n addition, $.C controller uses the detachable terminal connector, 6hich can ensure that the field connection is changeless 6hile removing and reinstalling &',"00 C$U and 3A4 module. 3nsert the scre6driver into the central notch of terminal block, press it do6n by force and then pry out the terminal connector.
21

@ange rous

Che car=uretor is in high%te!)erature state +hile +orDing. So" caution" scaldM

-o !oisture or +ater and etc enters into the air *ilter.

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O 9M"(%= +nalog input conversion module, 6hich is applicable for the analog,to,digital conversion of the acquired temperature, pressure, humidity signals, and then sending these results to C$U""5 for processing. 3n this control system, 2,"0Ma input is used. O 9M"(# analog input module, 6hich is applicable for the analog,to,digital conversion of the acquired temperature signals, and then sending these results to C$U""5 for processing. O Temperature transmitter :><;= >< series temperature transmitter is a "28CC po6ered, t6o,6ire, system, integrated transmitter 6hich converts the signals from the platinum thermal resistance to the electrical signals. a.4perating principle= The temperature sensor is affected by the temperature and then generates the electric resistance or potential effect, and this effect is converted and then produces a differential voltage signal. This signal is amplified and then sub/ect to the voltage,current conversion, and a 2 , "0m+ electric current signal corresponding to the measuring span is sent. b.Characteristics= +ccurate signal, remote transmission available, high precision, good long,term stability, maintenance,free.

Che ground +ire o* control )anel !ust =e relia=ly earthed" other+ise it !ay result the Eu!) o* te!)erature and )ressureM O $ressure transmitter= The pressure signal is converted to 2 , "0m+ electric current signal, and then changed to the digital signal via 9M"(% module. The digital signal displayed on the display is the actual pressure value. O 4perating principle of platinum thermal resistance= >ithin a certain range, $T#00?s resistance is linear proportional to the temperature. The resistance value increases as the increase of temperatureJ and the resistance value decreases as the decrease of temperature. +t the room temperature :"0 ;, $T#00 platinum resistance?s value is #0'.'- 4hms. The resistance signal of the platinum resistance is sent to 9M"(#, and transmitted to the display after conversion. Then, its actual temperature value is displayed on the display. 6. O)erating )rinci)le o* the control syste! The +ttached 1igure 5 sho6s the electrical schematic diagram of the control system. The control system uses the !erman &39M9B& Corporation?s C$U""5 as the main controller and the touch screen as the human,machine interface. 3n the control system, the temperature and pressure signals are acquired 6ith the &39M9B&?s standard module= The temperature,measuring probe $T#00 transmits the resistance signal to the thermal resistance module :9M"(# or 9M"(%; and then the signal is converted to the digital signal 6hich can be received by the programmable logic controllerJ and the pressure transmitter converts the pressure signal to the standard 2,"0 m+ electric current signal, and then the signal is converted by the analog module :9M"(%; to the digital signal and sent to the programmable logic controller for processing. The advantage of the analog control is that the continuous change of the temperature and pressure during sterilization process can be real,time measured by the programmable logic controller and displayed on the human,machine interface and the programmable logic controller is net6orked 6ith the computer in order to fulfill the monitoring of upper computer and store some important data into a database for archive,keeping and future reference. 1or the actual operation, all parameters must be ad/usted and preset according to the sterilization requirement of the goods to be sterilized, and the related sterilization procedure flo6s and 6ork methods are selected. $lease see Chapter 833 Use and 4peration for specific parameter setting. <efore operating, please carefully read electrical control schematic diagram, and understand the contents one by one according to the follo6ing descriptions. 4. Sterilization =asDet &ince this series sterilizer?s inner chamber is small in size, the double sterilization basket placement method is used to place the goods to be sterilized. The goods can be directly placed into the sterilization chamber, 6ithout the sterilization trolleys and carriers. The sterilization basket configured 6ith this series sterilizer features beautiful appearance, easy,to,use, and durable in use. To conform to the clean and
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hygienic standard, all materials of the basket are stainless steel and the basket is sub/ect to electric polishing treatment.

-o !odi*ication o* this deviceIs control syste! and )i)eline syste! +ithout )rior )er!ission or authorization o* our Co!)any is allo+ed" other+ise +e donIt )rovide any +arranty and a*ter%sale service *or this device.

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A . Use and O)eration

1. 8re)aration +orD =e*ore the use o* ne+ device + ma/ority of programs and parameters are already preset according to the related specifications and standards 6hen the ethylene oxide sterilizer leaves factory. <efore commissioning, check 6hether the connection, socket and other parts of electrical segment fall off or are loose, and tightened, if necessaryJ check 6hether the po6er supply and outside pipeline are correct in connection, other6ise it shall be ad/usted and tightened. O To ensure the reliable and safe commissioning, for the no,load commissioning, the ethylene oxide gas is substituted 6ith the air for the no,load test. The specific operation method is to manually turn the red button of the no,return valve base 6hen the program enters into the sterilization stage, open the valve and then close the valve after the pressure increases up to 5%0mbar. 12 Turn on the po6er s6itch at the rear side of the sterilizer, and press do6n the 4B button. 3n this case, on the .CC display appears the startup screen. 3n general, the po6er s6itch of the sterilizer is in the $4>97 4B state at all times, 6hich can simplify the operation and let the control system to continuously examine all 6ork conditions of the sterilizer. The display may give 7" or 7) alarm. 22 Co!!issioning o* co!)ressed air Turn on the po6er s6itch, and then press do6n the &T+7T button. >hen the pressure of compressed air inside the gas storage tank is less than 0.2M$a, the air compressor 6ill automatically startsJ and 6hen the pressure of compressed air inside the gas storage tank reaches 0.'M$a, the air compressor 6ill automatically stop running. 3f the display gives 7) alarm, it indicates that the pressure of compressed air is less than 0.2Mpa. +fter 6aiting for a 6hile, the air compressor 6ill start until the pressure of compressed air meets requirement, and then 7) alarm disappears. +fter the sterilizer operates for a period of time, the condensed 6ater 6ill appear in the gas storage tank, and the device 6ill automatically drain out the condensed 6ater. The condensed 6ater is drained out to the drain bottle. The drain bottle equips 6ith the liquid level s6itch, and the display 6ill dive an alarm signal 6hen the liquid level of the drain bottle reaches the upper level. 3n this case, the valve at the drain outlet shall be manually opened in order to drain out the condensed 6ater. $2 Co!!issioning o* hu!idi*ier +ater level 3f the display gives 7" alarm, it indicates that there is no 6ater in the humidifier 6ater storage tank or the 6ater level is less than the set level. The 6ater inlet is located at the rear end of the device. Unscre6 the filler nut and refill the distilled 6ater via the inlet until the level of 6ater in humidifier meets the requirement, and then 7" alarm disappears. The excessive 6ater filling rate isn?t preferred every time, 6ith the preferred refilling volume of %00 , '00ml.

/hen +ater re*illing" note that there is +ater s)illed *ro! the +ater storage tanD. 42 Co!!issioning o* heater )late +fter the commissioning program starts to run, touch the bottom of sterilizer and the external surfaces of heat insulating materials at both sides of the device, and you 6ill feel the considerable temperature rise. 4n the display 6ill display the increase of temperature value.

Che heating !e!=rane co!!issioning is used only +hen the heating *ault a))ears. Caution" scaldM 62 ChecD +hether all valves o)erate
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3n the manual operation state, open all solenoid valves, and gently close to the top of a solenoid valve 6ith an iron scre6driver. 3n this case, you shall feel the strong magnetic attraction force. 3f you have the feeling, it indicates that this valve is po6ered on and opened. 2. 8reheating te!)erature selection +fter the device is po6ered on or a sterilization cycle is completed, the system enters into the 4perating Menu #, and on the 4perating Menu # you can select the preheating temperature of the device body.

8lease select the sterilization te!)erature )rogra! C''4

$7sterilization )rogra!

C''4 6sterilization )rogra!

O)erating Menu 1 The !".C series ethylene oxide sterilizer has (' and %% sterilization temperatures for selection, and you shall read the user?s manuals for sterilizer concerned before sterilization and select the sterilization temperature according to the recommendation provided by the device manufacturer. >hen the sterilization temperature recommended by the device manufacturer is less than %% , select the (' sterilization programJ and if the sterilization temperature recommended by the device manufacturer is equal to or greater than %%, select the %% sterilization program. &election method= a &elect the preheating temperature according to the next sterilization cycle, and preheat it according to (' program if no selection b +fter selection of the preheating temperature, press the KConfirmL button to enter the 4perating Menu " $. O)ening and closing o* the door Touch the K4pen the front doorL button on the 4perating Menu " by hand, and the front door 6ill automatically open. Touch the KClose the front doorL button on the 4perating Menu " by hand, and the front door 6ill automatically close.

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inner chamber temperature= inner chamber humidity inner chamber pressure=

Ethylene Oxide Sterilizer

9quipment maintenance 4pen front door

operate program close front door

O)erating Menu 2 /ari ngs

9e*ore o)ening or closing the door" !aDe sure that there is no o=stacle in the door o)ening or closing travel. * there is an o=stacle" the syste! +ill give an alar! and sto) closing the door. 4. (un a )rogra! Touch the K7un a programL button in the 4perating Menu " by hand to enter the 4perating Menu (, and select the program to be run.

8rogra! 3nput 3nput time operator ventilation trend printout trend printout report printout report printout mi

return to )revious )age. O)erating Menu $ 3n this system has four programs= (' trend printout, (' report printout, %% trend printout, and %% report printout, and you can select various programs as required. The running of a program shall meet the follo6ing conditions= a 1ront door closes and the C.4&9 position shall be successfully inspected.
24

EO%&1$'%'1.('

b The pressure of compressed air is greater than 0.2M$a. c There is 6ater in the tank. d (' program inner chamber temperature shall be no more than 20 , and %% program inner chamber temperature shall be no more than %5. 3f any of the above conditions is unavailable, it 6ill give an alarm.

9e*ore selecting the Con*ir! )rogra!" enter the O)erator -o. 27272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 7272 72727272727272727272727272727272727272727272727272727272727272727272727272727enteren and Aentilation Ci!e. Che s)eci*ic ventilation ti!e is di**erent as the di**erent goods to =e sterilized. t is reco!!ended that the custo!er selects ventilation ti!e o* !ore than 12 hours *or 66 )rogra! or $2%$4 hours *or $7 )rogra!. 6. Syste! setting Touch the K7un a programL button on the 4perating Menu " by hand, input the pass6ord :the initial value is '); and then enter into the 4perating Menu 2. 3n the 4perating Menu 2, touch the K&ystem settingL to enter into the 4perating Menu %. 3n the 4perating Menu %, fulfill the system setting.
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Equipment Numbers,XG2.@C0%1$'

n)ut )ass+ord

Syste! !aintenance T007et

M007 3nvalid pass6ord, please input again. 7eturn confirm

Equipment

Change $ass6ord

3nput inspection

system settings manual output

O)erating Menu 4

O)erating Menu 6 4. $7 )rogra! heating +all te!)erature setting 3n the 4perating Menu %, touch the K(' 6all temperature settingL button to enter the 4perating Menu 5. 3n the 4perating Menu 5, control the (' program 6all temperature heating temperature.

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$7 +all te!)erature settings

Cabinet upper temperature Cabinet lo6er temperature 1ront door temperature heating

vaporization heating temperature

default

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O)erating Menu 4 8ara!eters setting range, a The input range of cabinet upper 6all temperature is (( , 2", and it restores to the default value () if out of range. b the imput of cabinet lo6er 6all is ((,2",and it restores to the deault value (- if out of range. c The input range of front door heating temperature is (( , 2", and it restores to the default value (- if out of range. d The input range of vaporization heating temperature is 50 , #%0, and it restores to the default value ##0 if out of range. Touch the KCefaultL button on the 4perating Menu 5, all parameters 6ill restores to the default parameters 6hen leaving factory. 7. 66 )rogra! heating +all te!)erature setting 3n the 4perating Menu %, touch the K%% 6all temperature settingL button to enter into the 4perating Menu '. 3n the 4perating Menu ', control the %% program 6all temperature heating temperature.

66 +all te!)erature settings

Cabinet upper temperature= Cabinet lo6er temperature= 1ront door temperature= vaporization temperature= heating heating

default

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O)erating Menu 7 8ara!eters setting range, a The input range of cabinet upper 6all temperature is %" , 5(, and it restores to the default value
2B

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() if out of range. b the imput of cabinet lo6er 6all is %", 5(,and it restores to the deault value (- if out of range. c The input range of front door heating temperature is %" , 5(,and it restores to the default value (- if out of range. d The input range of vaporization heating temperature is 50 , #%0, and it restores to the default value ##0 if out of range. Touch the KCefaultL button on the 4perating Menu ', all parameters 6ill restores to the default parameters 6hen leaving factory. 3. Ce!)erature rise s)eed setting 3n 4perating Menu %, touch the KTemperature rise speed settingL button to enter into the 4perating Menu ). 3n the 4perating Menu ), set the device heating speed.

Temperature settings
Upper arm temperature rise speed= .o6er arm temperature rise speed= 1ront door heating temperature speed= 8aporization heating temperature speed=

rising

speed

default

O)erating !anual 3 8ara!eters setting range, a The input range of upper arm temperature rise speed is (0sAdegree , ---sAdegree, and it restores to the default value ()0sAdegree if out of range. b The input range of lo6er arm temperature rise speed is (0sAdegree , ---sAdegree, and it restores to the default value (%0sAdegree if out of range. c The input range of front door heating temperature speed is (0sAdegree , ---sAdegree,and it restores to the default value 2%0sAdegree if out of range. d The input range of vaporization heating temperature speed is(0sAdegree, ---sAdegree, and it restores to the default value (50sAdegree if out of range. Touch the KCefaultL button on the 4perating Menu ), all parameters 6ill restores to the default parameters 6hen leaving factory. B. Aacuu! s)eed setting 3n the 4perating Menu %, touch the K8acuum speed settingL button to enter into the 4perating Menu -. 3n the 4perating Menu -, set the vacuum return speed of the device.

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8acuum speed settings

8acuum time limit= 8acuum return time limit= 8acuuminizing time interval=

& & &

default

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O)erating !anual B 8ara!eters setting range, a The input range of vacuum time limit is %0s,---s, and it restores to the default value ')0s if out of range. b The input range of vacuum return time limit is %0s,---s, and it restores to the default value %)0s if out of range. c The input range of vacuumizing time interval is %0s,---s, and it restores to the default value #"0s if out of range. 1'. Syste! ti!e setting 3n the 4perating Menu %, touch the K&ystem time settingL button to enter into the 4perating Menu #0. 3n the 4perating Menu #0, set the system time.

Clock settings

Current clock &et the clock yy,mm,dd,h,m, s

default return to previous page

O)erating !anual 1' Setting !ethod, a 3n the K&et the clockL column, input the time to be modified.
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b Touch the K&et the timeL button on the 4perating Menu #0, and a ne6 time takes effect. 11. 8rinter setting 3n the 4perating Menu %, touch the K$rinter settingL button to enter into the 4perating Menu ##. 3n the 4perating Menu ##, set the printer.

$rinting settings

$rinter status Curve speed 7eport speed print print

T4penAclose 0 sApixel sApixel

default

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O)erating !anual 11 8ara!eters setting range, a Touch the K4penACloseL button behind the K$rinter statusL, turn onAoff the printer. >hen the printer is po6ered on, the back circle becomes red. b The input range of curve print speed is 0sApixel , ---sApixel, and it restores to the default value #%sApixel if out of range. c The input range of report print speed is 0sAro6 , ---sAro6, and it restores to the default value #"0sAro6 if out of range. 12. Syste! )ara!eters setting Touch the K&ystem parametersL button on the 4perating Menu % by hand to enter into the 4perating Menu #". 3n the 4perating Menu #", click the KCigital inputL column behind the letter to modify the corresponding parameters.

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8ara!eters setting range, &ystem parameter

inner chamber temperature calibration lo6er chamber temperature calibration upperr chamber temperature calibration front door calibration vaporization calibration temperature temperature

next

return page O)erating !anual 12 &ystem settings

3nner chamber calibration

pressure

mbar mbar H s s

3nner chamber at zero position 3nner chamber calibration humidity

door opening time limit door closing time limit obstacle alarm time

previous page.

O)erating !anual 1$ 8ara!eter descri)tion a The input range of inner chamber temperature, bottom temperature, top temperature, front door temperature, carburetor temperature, inner chamber pressure, inner chamber humidity correction is ,-.- , V-.-, and its initial value is 0 b The input range of inner chamber pressure at zero position is )00mbar , #0"2mbar, and it restores to the initial value #000mbar if out of range. c The input range of door opening time limit is 5s,#"s, and it restores to the initial value #)s if out of range. d The input range of door closing time limit is #0s,")s, and it restores to the initial value ""s if out of range. e The input range of obstacle alarm time is 0s, %s, and it restores to the initial value #s if out of range.

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1$. Creat!ent o* goods to =e sterilized and )recautions 12. Goods cleaning +ll goods to be sterilized shall be completely cleaned before sterilization because the ethylene oxide gas can?t kill the microorganism covered by the organics. 3f the goods aren?t completely cleaned, the sterilization may be unqualified. 3t is best to immediately clean the goods after the use. 22. Lu!idity assurance + certain humidity is necessary to the ethylene oxide sterilization. .o6 humidity may affect sterilization effect. The moisture may result in the expansion of microbial cells, 6hich is helpful to the gas penetration and alkylation function. The sterilization failure is generally caused by lo6 humidity. &o, the goods or package shall be pre,stored in the environment of (%H 7.F., 6here %0H 7.F. is preferred. The sterilizer can humidify the goods during the pre,treatment process in order to ensure that the indoor humidity meets the related requirement.

9e*ore running a )rogra!" )lease +i)e o** the +ater dro)let *ro! the sterilization cha!=er. Che liHuid%state +ater reacts +ith the ethylene oxide gas" +hich )roduces the ethylene glycol +ith toxicity +hich is di**icultly re!oved at the ventilation stage. $2. Goods )acDage <efore sterilization, some goods shall be packaged for storage. $lease use the packing materials 6ith the follo6ing characteristics. W 9asy for the ethylene oxide gas penetration and humidity penetration W 9asy for air motion, 6hich ensures that the packaging bag can?t break under the vacuum condition W 9asy for gas volatilization after sterilization W Fave sufficient intensity, 6hich ensures it isn?t damaged 6hile handling W $rotect the goods in the packaging bag, 6hich avoids the occurrence of secondary pollution

The follo6ing materials can?t be used for packing Bylon film, polyester film, aluminum foil, metal or glass /ar, glass paper 42. Goods loading The placement of goods in the basket shall be in favor of the air ventilation and the humidity and ethylene oxide penetration. 3t is recommended that the goods shall be vertically placed in the basket, and isn?t leaned against the side 6all of inner chamber, 6ith gap bet6een the goods. 1or the lamination packaging, place it absolutely according to the paper,to,plastic order. 3f the goods must be horizontally placed, the paper surface must be placed do6n6ards. 14. 8recautions =e*ore starting the sterilization cycle 12 8rinter )a)er checD Turn on the printer, check 6hether the printer paper is used up, and please replace it in time, if used up.

/ari ngs notic es

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Che ther!osensitive )rinter )a)er should not =e long stored" and it is =est to store a co)y a*ter du)lication i* the docu!ent needs to =e stored *or !ore than 2 years. Co avoid the da!age o* the )rint head" )lease use the standard )rinter )a)er" and )re*erentially )urchase the )a)er directly *ro! the sterilizer !anu*acturer. 22 (e*ill the distilled +ater The distilled 6ater is required 6hen humidification, and the 6ater inlet is located at the rear of the sterilizer. Unscre6 the filler nut to directly refill the 6ater. 3n general, the preferred 6ater refilling volume is %00 , '00ml every time, and either excessive or small 6ater is unsuitable. $2 Con*ir! the gas Ear <efore running a program, confirm that the ethylene oxide gas /ar is already placed into the 94 chamber and the gas /ar is unused.

notic es
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. Maintenance and (e)air

1. Manual o)eration Touch the KManual outputL button on the 4perating Menu 2 by hand, and enter into the 4perating Menu #2. 3n the 4perating Menu #2, manually operate all parts to check 6hether they normally 6ork.

O)erating !anual 14

O)erating !anual 16 O)erating !ethod, Touch the K4BA411L button behind the letter by hand, and then conduct the startAstop treatment of the related parts. 3f the part starts, the corresponding circle behind it becomes red. <y touching the K$age UpL or K$age Co6nL button, the change bet6een the 4perating Menu #2 and #% is available.

#; The action bet6een opening and closing the front doors is interlocked and the doors can?t be simultaneously opened.
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"; The action bet6een opening and closing the medical valves is interlocked, and these valves can?t be simultaneously opened. (; >hen the pressure of inner chamber is belo6 the K3nner chamber pressure zero positionL, the door can?t be opened and closed. 2. n)ut checD Touch the K3nput checkL button on the 4perating Menu 2 by hand, and then enter into the 4perating Menu #2. 3n the 4perating Menu #2, vie6 the 6orking condition of all monitoring points in order to check 6hether they normally 6ork.

O)erating !anual 14 >hen checking 6hether the part has signal input, the corresponding circle behind the letter becomes red. $. (estore to *actory setting Touch the K7estore to factory settingL button on the 4perating Menu % by hand, and then enter into the 4perating Menu #%. 3n the 4perating Menu #%, initialize all parameters of the system setting.

Confirm to resetting to factory parameterX

Cancel

confirm

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O)erating !anual 17 To determine the factory parameter resetting, touch the KConfirmL button. To cancel the factory parameter resetting, touch the KCancelL button. 4. Edit )rogra! Touch the K9dit programL button on the 4perating Menu % by hand, and then enter into the 4perating Menu #). 3n the 4perating Menu #5, edit all parameters of (' or %% program.

$rogram editing

7eturn

(' sterilization

%% sterilization

O)erating !anual 13 To edit the (' sterilization program, touch the K(' sterilizationL and then enter into the 4perating Menu #-. To edit the %% sterilization program, touch the K%% sterilizationL and then enter into the 4perating Menu "0.

O)erating !anual 17

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O)erating !anual 13

8ara!eters descri)tion, 12 8ulsation vacuu! lo+er li!it 3t means minimum control pressure of inner chamber vacuumizing in case of vacuumizing or pulsation ventilation. The range of #00mbar , "20mbar is set, and it restores to its initial value #)0mbar if out of range. 22 8ulsation vacuu! u))er li!it 3t means the maximum control pressure of inner chamber vacuum,return in case of vacuumizing or pulsation ventilation. The range of 200mbar ,'00mbar is set, and it restores to its initial value 5%0mbar if out of range. $2 Aacuu! )ressure !aintaining ti!e 3t means the control time at the vacuum pressure maintaining stage. The range of #%min,%0min is set, and it restores to its initial value "0min if out of range. 42 8er!issi=le leaD li!it 3t means the maximum permissible leakage rate of inner chamber at the vacuum pressure maintaining stage. The range of #0mbar , '0mbar is set, and it restores to its initial value "0mbar if out of range. 62 Goods hu!idi*ication hu!idity 3t means the maximum control humidity of the goods humidified at the humidification stage. The range of 20H , )0H 7.F. is set, and it restores to its initial value '0H :%% program; or '0H :('
$B

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program; if out of range. 42 Che!ical re*illing )ressure%return li!it 3t means the minimum limit of the inner chamber pressure rise after chemical feeding at the chemical refilling stage. The range of "00mbar , %00mbar is set, and it restores to its initial value (00mbar if out of range. 72 Sterilization ex)osure ti!e 3t means the contact time of the goods and the ethylene oxide at the sterilization stage. (' program =The range of #)0min,500min is set, and it restores to its initial value #)0min if out of range. %% program=The range of 50min,500minis set, and it restores to its initial value 50min if out of range. 32 Exhaust )ulsation ti!es 3t means the number of replacement of the ethylene oxide gas in the inner chamber by the pulsation method at the exhaust pulsation stage. The range of ( times,#00 times is set, and it restores to its initial value % times if out of range. B2 &ir ventilation ti!e 3t means the time at the ventilation residual,removing stage. The range of #"0min,#"00min is set, and it restores to its initial value '"0 min if out of range.

6. &lar! )rocessing >hen the system is abnormal, the device gives an alarm to remind the customer of the resulted failure of the device. +larm menu

Yuit

alarm confirm

&lar! !enu
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The alarm information and codes are as follo6s= +#= .ong front door opening time@ +"= .ong front door closing time@ +(= 1ront door overcurrent protection@ +2= 7ear door overcurrent protection@ +%= 1ront door has obstacle@ +5= 1ront door not close, fail to run@ +'= .o6 inner chamber pressure, fail to open door@ +)= Figh inner chamber temperature, cooling required@ +-= $rinter not po6er on@ +#0= .ong rear door opening time@ +##= .ong rear door closing time@ +#"= 7ear door has obstacle@ +#(= 7ear door not close, fail to run@ 7#= Chemical already fed, fail to reset@ 7"= .o6 level of 6ater in the feed tank@ 7(= .ong cabinet upper arm temperature rise time@ 72= .ong cabinet lo6er arm temperature rise time@ 7%= .ong front door 6all temperature rise time@ 75= .ong carburetor temperature rise time@ 7'= .o6 vacuumizing speed@ 7)= .o6 compressed air pressure 7-= &ystem po6er off@ 7#0= Figh level of 6ater in the drain tank, please drain@ Y#= 8acuumizing failure@ Y"= Begative pressure maintaining failure@ Y(= &lo6 pressure rise, chemical refill failure@ Y2= 1ast pressure rise, it may leak@ Y5= &lo6 vacuum return, vacuum return valve abnormal@ Y'= $enetration cylinder not in proper position, possible penetration failure@ Y) Bo 6ater in tank, humidification failure@ 9#= $ressure sensor abnormal@ 9"= Fumidity sensor abnormal@ 9(= 3nner chamber temperature sensor abnormal@ 92= Cabinet body upper arm temperature sensor abnormal@ 9%= Cabinet body lo6er arm temperature sensor abnormal@ 95= 1ront door 6all temperature sensor abnormal@ 9'= Carburetor temperature sensor abnormal@ 9)= Communication failure@ 9-= &pare pressure sensor abnormal@ 4. Co!!on trou=leshooting Curing the device running process, some unanticipated special events unavoidably happen. &ome problems and its corresponding troubleshooting are summarized as follo6s.

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S: #

8ro=le! descri)tion .ong door opening or closing time

&lar! code +# +"

Crou=leshooting #; Check 6hether the door opening or closing limit s6itch is misplaced or faulty "; +ppropriately enlarge the door opening or closing limit in the &ystem parameters setting

"

Coor opening or closing overcurrent protection

+" +(

#; Check the door travel and 6hether it has obstacle or 6hether the friction force is excessive "; +ppropriately enlarge the electric protective current of motor protection plate.

&lo6 device preheating temperature rise

7( 72 7% 75

#; Check 6hether the device?s po6er supply voltage is normal. "; Check 6hether the heater band has trouble

8acuumizing failure

Y#

#; Check 6hether the vacuum pump, vacuum control valve and vacuum pipeline have trouble. "; Check 6hether the door isn?t closed and has leak.

$ressure maintaining failure

Y"

#; Check the door closing position and 6hether it is closed to its proper position. "; +d/ust the gap bet6een he door and seal rubber strip in order to get good seal (; Check the humidification pipeline and vacuum return pipeline, and 6hether it has leak.

$enetration failure

Y( Y'

#; Check 6hether the pressure of compressed air is normal. "; Check 6hether the chemical filling valve and connecting 6ire are normal. (; Check 6hether the cylinder and its connecting pipeline are normal.

'

.o6 vacuum return speed

Y5

#; Check 6hether the vacuum return valve can be normally opened or closed. "; Check 6hether the filter and vacuum return pipeline are clogged.

+bnormal communication bet6een the display and controller

9)

#; Check 6hether the connection bet6een the display and controller is dropped off or broken. "; Check 6hether the "28 po6er voltage is normal

$ressure sensor abnormal

9#

#; Check 6hether the connection bet6een the sensor and controller is dropped off or broken. ";

#0

Fumidity sensor abnormal

9" 42

EO%&1$'%'1.(' ## Temperature sensor abnormal 9( 92 9% 95 9'

The above simply lists some common problems and troubleshooting only. 3f you still have any question, please contact our Company?s local customer service representative.

X. Others
3f any sterilization device 6ants to get reliable sterilization effect, apart from the device design, manufacturing quality and perfect maintenance and care, the key factor to get successful sterilization is that the sterilization personnel properly understands the basic kno6ledge of sterilization, is familiar 6ith the operating principle of the device, strictly follo6s the operational specifications of sterilization and seriously takes any regulation related to the sterilization. 1. Sel*%)rotection >hen the sterilization is done, the staff must have the self,protection consciousness and take the self, protection measures to prevent the occurrence of a sterilization accident and the personal in/ury caused due to the improper operation. 2. Sterilization Huality assurance 1 &ssured cleanness o* the goods to =e sterilized The cleanness is the key factor of successful sterilization, especially for some medical supplies 6hich are difficultly cleanedJ it 6as researched and found overseas that the complete cleanness can decrease by ( Z 2 logarithms of bacterial load and greatly reduce the content of organismJ if the organism and other containments can?t be effectively removed, it 6ill greatly reduce the activity of sterilant, and the bacteria hidden in the organism are difficultly killed by sterilantJ and thus the 6hole sterilization process 6ill fails if the cleanness is incomplete. +ttention must be paid not to reduce the cleanness requirement by extending the sterilization time and increasing the temperature of sterilantJ and the enzymatic cleaning agent is preferably used to strengthen the cleanness effect in order to conveniently and effectively remove the organism.

!)ro)er cleaning canIt ensure the Huali*ied sterilization. 22 Environ!ent o* sterilization roo! O The floor of sterilization room must be even and smooth, and the operation area must be kept clean and dry. The roof shall be laid 6ith a ceiling in order to prevent the dust deposition. The 6all shall be flat and clean and separated from the cleaning, preparation and other operating rooms. O The exhaust outlet of 6aste gas must penetrates through the 6all and the 6aste gas is exhausted to the airJ and 6aste gas can?t flo6 back and invade into the sterilization room. O + ventilation device is installed onto the top end face of the 6all or the proper position of ceiling. O $artition from other device must be done. &ince the sterilization device uses the ethylene oxide gas as the sterilization medium, it is recommended that the colorful steel plate or other materials are used to partition the ethylene oxide sterilization room after the devices are installed onto its proper positions. This 6ill effectively prevent the influence of the ethylene oxide on the ambient environment and greatly improve the 6orking condition of the sterilization room. $2 8re)aration and reHuire!ent o* the goods O >hen all kinds of large packages are placed in order into the sterilization basket, #0mm gap shall be kept among these packages, and the loading capacity shall be no more than )0H of the volume of inner chamber in order to let the ethylene oxide gas to smoothly circulate.
4$

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O >hen all kinds of small packages are placed in order into the sterilization basket, the placement principle of the goods in the basket is to make for the air ventilation and the humidity and ethylene oxide penetration. Tt is recommended that the goods shall be vertically placed in the basket, and isn?t leaned against the side 6all of inner chamber, 6ith gap bet6een the goods. 1or the lamination packaging, place it absolutely according to the paper,to,plastic order. 3f the goods must be horizontally placed, the paper surface must be placed do6n6ards. O The containers and transport tools shall be cleaned and sterilized every day. $. Exa!ination o* sterilization e**ect The examination of sterilization effect is a necessary means to evaluate the rationality of its sterilization method and the reliability of the sterilization effect. The examination methods include the physical examination, chemical examination and biological examination= the goods shall be sub/ect to the steriling test after the completion of sterilization and can be used only after qualified. 12 )hysical !onitoring The physical monitoring is mainly to reflect the status of sterilizer, and means 6hether the sterilizer?s all key parameters meet the design requirement or the requirements set in this sterilization, i.e., 6hether the sterilizer?s temperature, pressure and humidity meet the related requirements. The device equips 6ith the thermal printer 6hich can print out the sterilization data record paper for archiving and future reference. The record paper can record the pressure, temperature and relative humidity at all sterilization stages during sterilization process, and also can record the number of operations of the device, sterilization temperature, ventilation time and other related parameters. Checking 6hether these values meet the corresponding requirements can preliminarily determine 6hether sterilization effect is good or bad. The physical monitoring can?t truly reflect the sterilization process and microorganism killing condition of all packages in the sterilizer, and only its combination 6ith the chemical monitoring and biological monitoring can comprehensively reflect the quality of sterilization. 22 che!ical !onitoring The chemical monitoring is mainly to visually check the :status; change in matter or chemical :color; change, and thus test the parameters of sterilization process. The chemical monitoring is quick, simple and 6ith lo6 cost, 6hich is used to find possible occurrence of sterilization failures, such as incorrect packing or loading, sterilizer function failure and so on. The chemical examination is mainly used to check the outside of any package in order to differentiate the sterilized and non,sterilized goods, and the commonly,used tools include the chemical indicator tape, color bar and label on the packaging tape, and etc. 3n addition, there are also the single parameter chemical indicator, multiple parameters indicator and other chemical test methods. 4ne surface of chemical indicator tape is applied 6ith adhesives, and the other side is applied 6ith the chemical indicator. The tape isn?t only used as the indication to differentiate K&terilizedL and KBot sterilizedL, but also is used as the package strip seal and adhered to the external surface of the package. +fter the completion of sterilization, the uniform change of the indictor color can indicate 6hether the goods are already sterilized, and thus further demonstrates the possibility of success of sterilization.

Che che!ical indicator *or exa!ination shall =e a))roved =y the related health de)art!ents and +ith the hygiene license issued" and used +ithin +arranty rangeM $2 =iological !onitoring The biological monitoring is mainly to use the standardized bacterial strain and the package, 6hich meets the requirements, to evaluate 6hether it meets the sterilization requirement. 3t mainly includes the follo6ing aspects. O &elect the biological indicator meeting the requirements
44

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The ethylene oxide biological indicator is bacillus subtilis var.niger :+TCC'-%(; spore, 6ith the culture temperature of (5N#, according to the Central sterile supply department (CSSD) Part III: surveillance standard for cleaning, disinfection and sterilization formulated by the Ministry of Fealth of the $eople?s 7epublic of China. O Use the testing suite conforming to the related standards +ccording to the Central sterile supply department (CSSD) Part III: surveillance standard for cleaning, disinfection and sterilization formulated by the Ministry of Fealth of the $eople?s 7epublic of China, as the routine testing suite for the common biological monitoring, a biological indicator is placed into a "0ml syringe, and the core of syringe is placed onto its original position, the syringe needle and its sleeve are removed, and the plastic cap of biological indicator aligns 6ith the syringe needle. 3t is packed in t6o layers 6ith a cotton to6elette, and then placed into a packaging bag. The testing suite shall be placed into the difficult sterilization position of the sterilizer, and generally in the center among those goods to be sterilized. O Treatment= 3f the sterilization is unqualified, temporarily store this batch of goods, find out the possible causes of sterilization failure, and then sterilize and treat those goods againJ re,examine the sterilizer?s sterilization effect 6ith the same manufacturer?s multiple biological indicators or multiple manufacturers? same kind of biological indicatorJ and carefully check these biological indicators? date of manufacture, effective date, 6hether these indicators are broken or damaged and 6hether those indicators are contaminated during the culture process. O 4ther examination methods approved by the Ministry of Fealth of the $eople?s 7epublic of China are available. 7eferring to its instruction for use, the biological examination is done for the sterilization effect. O The examination results shall be recorded, including= inspection date, sterilizer number, sterilization temperature, sterilization time, source of indicator, batch number and period of validity, culture temperature, culture time, observed results and inspector.

&*ter the carriers *or =acteria are sterilized" taDe o** the carriers in ti!e and then culture the!. The physical examination, chemical examination and biological examination methods have its o6n different purposes and meanings, and thus they can?t be mutually substituted and shall be mutually combined in use. $hysical examination Z 3t can illustrate the operation condition of the sterilization device itself, and visually display the time, temperature, pressure and other related parameters during 6orking process. Chemical examination Z 3t can examine 6hether the sterilization process is completed, provide the first visual check at the moment after the completion of sterilization, and assist to determine the effect of sterilization. <iological examination Z 3t is mainly used for the final determination of sterilization effect, but 6ith high cost and long time. 4. Energy%saving and environ!ental )rotection +lthough the environmental protection and the energy,saving during running process are fully considered during the device design process, you may use this device to disinfect and sterilize the special goods. &o, you should timely contact our Company in order that 6e can appropriately ad/ust the program 6hich you use in order to minimize the consumption and save the energy.

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X. &))endix
1. O)erating )rocedures K&hinvaL brand ethylene oxide sterilizer operating procedures 2. &ttached technical dra+ings +ttached 1igure #= &tructural diagram of the device +ttached 1igure" =$*3C diagram +ttached 1igure (= !".CCG,#(0 installation diagram +ttached 1igure 2= !".CC8,""0 installation diagram +ttached 1igure %=>iring diagram +ttached 1igure 5=>iring diagram +ttached 1igure '=$o6er supply schematic diagram 3 +ttached 1igure )=$o6er supply schematic diagram 33 +ttached 1igure -=Chemical filling valve +ttached 1igure #0=9lectric drive pusher control circuit diagram +ttached 1igure ##=9lectric heater band control circuit diagram +ttached 1igure #"=8acuum pump control schematic diagram +ttached 1igure #(=+nalog input schematic diagram +ttached 1igure #2=Cigital input output schematic diagram +ttached 1igure #%=Cigital input output schematic diagram +ttached 1igure #5=+ir compressor control circuit diagram

;Shinva< =rand ethylene oxide sterilizer o)erating )rocedures

#. 8re)aration =e*ore on%duty, [ Turn on the po6er s6itch connected 6ith the sterilizer. [ Turn on the device control po6er, and turn the sterilizer po6er s6itch to the 4B position to preheat the device, and prepare for the running of the program. [ Clear up the goods to be sterilized, and adhere the chemical indicator card to the outside. $. Sterilization o)eration, [ 4pen the seal door, and place the ethylene oxide gas /ar into 94 chamber in sterilization room. [ 4pen the seal door, push the goods to be sterilized into the sterilization chamber, a gap shall be reserved bet6een one package and the other package, and its peripheries shall not be closed to 6alls and door panel. [ Close the seal door, select the sterilization program according to the goods to be sterilized, check 6hether the sterilization parameters are correct, and start the run program. [ Curing sterilization process, the operator shall check the operating condition of the device, and if it is abnormal, it shall be timely treated in order to prevent the occurrence of an accident. [ Conduct the monitoring of sterilization effect, record and store the results for tracking and investigation. [ +fter the completion of sterilization, 6ait for the indoor pressure resetting, and then open the rear door to take off the goods. %. /orD a*ter o**%duty, & 4pen the front door, turn the po6er s6itch to the 411 position in order to shut off the device control po6er and motor po6er.
44

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&

Take off the used ethylene oxide gas /ars and carefully store them.

+fter the completion of daily 6ork, the outside and inside of the sterilizer and its operating room shall be kept clean, and the contaminations shall be completely removed from the sterilization chamber, 6ith the frequency of one oil service every 6eek and one ma/or service every month. '. 8recautions, \ The sterilized goods shall not be stored 6ith non,sterilized goods. \ 4n the qualified sterilized goods shall be indicated 6ith sterilization date, certificate mark. -a!e o* end user, @ate, .. MM

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#. Main body ". &upport (. Coor assembly 2. $ipeline system %. <asket 5. 4uter cover '. 9lectrical system Structural diagra! o* Shinva =rand Model XG2.C ethylene oxide sterilizer

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