pure eto gas manual-1

8/13/2019 Pure Eto Gas Manual-1

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14XG2.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 Users 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 oxidesterilizers.

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

Medical device Manu*acturing Enter)rise #icense -o,#GXSCX -o. 2'1'''24

-o. o* hygiene license *or )roduction enter)rise,#/X00 2''$ -o. '23

-o. o* registration certi*icate *or !edical device#S5X00 2''3 -o. 267'277

8roduct standard09:# '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.................................................................................)

". +luminumcanned 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#

#. &elfprotection......................................................................................................................................2(

". &terilization quality assurance.............................................................................................................2(

(. 9xamination of sterilization effect.......................................................................................................22

2. 9nergysaving and environmental protection......................................................................................2%

#. 4perating procedures...........................................................................................................................25

;Shinva< =rand ethylene oxide sterilizer o)erating )rocedures...........................................................4

". +ttached technical dra6ings................................................................................................................25

&ttached >igure 1, Structural diagra! o* the device............................................................................4

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&ttached >igure2 ,8?@ diagra!...........................................................................................................4

&ttached >igure $,XG2.@C0%1$' installation diagra!........................................................................4

&ttached >igure 4,XG2.@CA%22' installation diagra!.........................................................................4

&ttached >igure 6,/iring diagra!.........................................................................................................4

&ttached >igure ,/iring diagra!.........................................................................................................4

&ttached >igure 7,8o+er su))ly sche!atic diagra! ..........................................................................4

&ttached >igure 3,8o+er su))ly sche!atic diagra! ........................................................................4

&ttached >igure B,Che!ical *illing valve ..............................................................................................4

&ttached >igure 1',Electric drive )usher control circuit diagra! .............................................. .......4

&ttached >igure 11,Electric heater =and control circuit diagra! .......................................................4

&ttached >igure 12,Aacuu! )u!) control sche!atic diagra! ............................................... .......... .4

&ttached >igure 1$,&nalog in)ut sche!atic diagra! ..........................................................................4

&ttached >igure 14,@igital in)ut out)ut sche!atic diagra! ..............................................................4

&ttached >igure 16,@igital in)ut out)ut sche!atic diagra! ..............................................................4

&ttached >igure 1,&ir co!)ressor control circuit diagra!................................................................4

. /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.

indicates that the contents shall be highly regarded.

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

indicates that these instructions shall be strictly follo6ed, other6ise it may endanger the

personal safety.

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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.

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 6ellventilated, dry, moistproof and hightemperature

location.

This sterilizer uses the ethylene oxide gas as the sterilization medium. The ethyleneoxide 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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39C 2#', Bo.%0(5

1use

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

This >ay Up

!hen in the air contains (H ethylene oxide, itgenerates the explosive gas mixture 6hich may result the burning or explosion if it catches the fire.

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 $9 :$ermissible9xposure 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 isinfection formulated by the Ministry of Fealth of the $eople?s 7epublic ofChina defines that the 6orking environment shall be 6ellventilated. uring )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

$oisoningMethod

$oisoning &ymptom 9mergency Treatment

+cute

inhalation

7espiratory tract irritation,

dizziness, 6eakness, vertigo,

sickness, and neurotoxicitysymptoms 3mmediately inhale the fresh air, quickly get tohospital or see a doctor

Chronic

inhalation

&uspicious carcinogenesis,

teratogenesis

9ye

contact

&erious eye irritation and

in/ury

3mmediately 6ash the eyes for at least #0

minutes, and then immediately see a doctor

&kin

contact

iquidstate ethylene oxidecauses the skin irritation,

dermatitis and blister

3mmediately 6ash the skins for at least #0

minutes, take off the contaminated clothes and

6ash it 6ith soapy 6ater, and then see a doctorquickly as possible

+limentarycanalcontact

&erious irritation and burningof the mucous membrane ofalimentary canal

3mmediately inform the doctor or local $oison

Control Center, and actively induce the sicknessafter drinking 6ater. Fo6ever, for the patient6ith dottiness, no induction of sickness or

feeding of any food is allo6ed

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 commonlyused 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 Khighpurity 94 sterilantL, and one /ar of gas 6ill be consumed

every a sterilization cycle. To ensure the necessary sterilization concentration, these sterilizers ofdifferent volumes shall equip 6ith the ethylene oxide gas /ars of different 6eight specifications.

7efer to the table belo6 6hile selection=

94 gas /ar parameters

&terilizer Model

Model>eight of the ethylene oxide

contained

!".CG#(0 G#00 #00g

!".C8""0 8#'0 #'0g

The ethylene oxide gas /ars shall be stored in a specified cool and 6ellventilated location, and thestorage environment temperature shall be controlled belo6 (0J and the ethylene oxide shall be far

a6ay from the strong acid, strong base, strong oxidant, ferric chloride, aluminumr chloride, stannicchloride, 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.

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

$. #eaD and its e!ergency treat!ent o* the ethylene oxide gas ar

3f any of follo6ing phenomena appears, it indicates that the ethylene oxide has already leaked from thegas /ar.

The liquidstate 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, drypo6der 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.

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. he )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 broadspectrum sterilant. 3t is generally stated that it can take the nonspecific alkylation function

6ith the microorganism?s protein, B+ 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 micropores and get to the deep portion of the goods, and thus fulfill thesterilization 6ith package and extend the storage time of the goods at germfree condition.

Bonoxidation, and noncorrosion=

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 nonoxidation process, it results very small damage of the goods and has very 6ide applicationfor the sterilization of heatsensitive 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 thesterilant soaking, dry heat, pressure steam and other chemical gases.

>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 lo6temperature 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 heatsensitive, humiditysensitive and corrosion

sensitive goods, the ethylene oxide sterilization sho6s its unique advantages even more. +lthough theethylene oxide sterilization has many advantages, it also has some disadvantages.

The ethylene oxide sterilization is inapplicable for the liquidstate 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

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 thefull process running, and he can monitor realtime the generation of unusual signal until the sterilization

cycling process finishes.

Uni*or! sterilization concentration,

The quantified smallpacking special pure 94 gas /ars are used, and the contained ethylene oxide isstable in quality, 6ith the effective constituent of --H or higher :executive standard !


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stage, the po6eroff memory function is available, 6ith the continuous and reliable sterilization time.

The sterilization time can be realtime displayed on a C display.

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 humiditysensor is set in order to automatically examine the relative humidity inside the chamber and thus make it

get the accurate control.

2 Sterilization o)eration sa*ety control,

O The fullprocess negativepressure 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 guaranteeprocedure, 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 onlyunder the sterilization chamber deep vacuum condition, and the effectivelycontrolled 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 effectivelyprevent the possibility of occurrence of misoperation.

$ @yna!ic dis)lay o* sterilization )rocess,

+ special blue or full color C 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 C display can realtime display the currentpressure, temperature or pretreatment 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 relatedalarm code, and reminders the operator to remove the trouble.

4 (eal%ti!e )rintout o* sterilization )rocess,

The sterilizer has the builtin highresolution thermal printer system. uring 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.

6 (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 po6eroff. +fter po6er on again, the sterilizer continuously 6orks, 6ithout re

startup, 6hich 6ill save the sterilization consumption and improve the efficiency of sterilizationoperation.

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A. echnical 8ara!eters

1. S)eci*ications o* the sterilizer

4rder Bo.

Technical parameters !".CG#(0 !".C8""0

&ize of sterilization chamber :x>xF;

mm'%0x2%0x200 #"%0x2%0x200

8olume of sterilization chamber #(% ""%

imensions :x>xF; mm -%0x)50x#'(0 #2%0x)50x#'(0

$ackage size :x>xF;mm #0%0x-50x#-00 #%%0x-50x#-00

Bet 6eight Eg (00 200

$o6er +C""0A%0Fz (E6 2E6

&terilization temperature ('and %% ('and %%

9thylene oxide gasAcycle #00g #'0g

istilled 6aterAcycle "0 (0ml (0 20ml

A. @evice nstallation

1. >ield installation reHuire!ents

1. Environ!ental reHuire!ent,

9nvironmental temperature= % 20

7elative humidity :7.F.;= P)%H

+tmospheric pressure= '0k$a #0%k$a

2. Energy source reHuire!ent,

$o6er= +C ""0 8N""8, %0FGN#FGCompressed air= %0 Amin

$. 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 theoutlet 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.. coppertube or "5mm 3.. * ("mm 4.. polyethylenealuminum composite tube is used.

O The length of air exhaust duct shall be no more than -0m, and the horizontal piping shall be reduced as14


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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 additionallyinstalled.

O >hen the length of air exhaust duct is more than (0m, another air exhaust duct shall be reserved foremergency 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.

4. @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. evice 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 atleast reserve #.% times of the overall length of the device in order to conveniently open and close the doorand ensure that the sterilization basket can freely enter into and exit from the sterilization chamber.

6. (oo! ventilation reHuire!ent

The 6ellventilated 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.

. Sterilization gas storage reHuire!ent

a. The storage and use of sterilization gas shall conform to Regulations on the Control over Safety of

Dangerous Chemicalsand other related regulations and standards.

b. The sterilization gas shall be stored in a cool, 6ellventilated warehouse.It shall be far away from the fire source,spark, and heat source, without exposureto direct sunlight. The temperature ofwarehouse shall be no more than 30. Thestorage of gas shall be separated from theacid, base, alcohol and food chemicals, andthe mixed storage is prohibited. Theexplosionproof lighting, !entilationfacilities are used. "o mechanical de!iceand tool which can easily produce sparkare used. In the storage area the leakemergency treatment de!ices shall bepro!ided.

2. nstallation )rocess" !ethod and )recautions

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a. Un)acD

he )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 lefthand or righthand 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 thedevice 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 themovement of the device during operation process;.

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

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.

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hen handling thedevice, 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 an7c#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 orderto easily install the device.

c. (e!ove the door )anel su))orting )lateTo ensure that the components of the product isn?t damaged during the longdistance 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 operatesthe 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 lefthand cover of the device. 4 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 lefthand side of the device, and carefully store the

removed supporting plate and scre6s for future use. The specific position of the supporting plate issho6n 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 #= evice composition dra6ing.

1. Main =odyO The main body is 6ith the rectangular plus reinforcement bar structure, 6hich doesn?t only ensure that

the device has enough high pressurebearing 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 issub/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 highquality heatinsulating materials, 6hich isn?t

only attractive and durable but also minimizes the thermal radiation of the device and effectively protectthe 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+itchThere are t6o door travel s6itches 6hich are limited to the C4&9 or 4$9B position and installed onto

the upper or lo6er of the rail. 3f the travel s6itch at the C4&9 position isn?t engaged, the program can?t

start and run.

$O%ringO &tructure= 4ring is a speciallyprocessed annular irregularlyshaped silicon rubber ring, and itsmaterial composition, shape design, correct installation and maintenance are very important to its normaloperation and service lifetime. The 4ring 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 4ring is enchased into the seal groove of front panel of the main body. >hen the seal

door is closing, the 4ring closely adheres to the seal surface of door panel of the seal door, andgenerates a certain deformation during sealing process and thus fulfills the sealing of the door.

O Maintenance= +lthough the long service lifetime of 4ring is fully considered in the design and

material selection, the follo6ing several factors may result the service lifetime of the 4ring, and these

factors shall be avoided as possible in order to ensure the longer lifetime of the 4ring.

a. +fter a cycle finishes, the seal door shall be in 4$9B position, other6ise the 4ring 6ill be graduallyaged 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.uring use, more attention shall be paid to avoid that the hard ob/ect impacts the 4ring, other6ise it

very easily result in its permanent damage and difficultly implements the reliable sealing of the 4ring.

O 1ailure= 3f any of the follo6ing causes is found, it is basically determined that the 4ring fails.

a.The surface of the 4ring is obviously hardened, and you may feel the absence of elasticity 6henpulling and dragging and some netted pull textures are found.

b.The 4ring 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 use

1B


20/48

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

aDe%o** and installation,

>hen the 4ring 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 4ring 6ith thumbs of both hands, and then take off the 4ring

from the seal groove.

>hen installing the 4ring, place the /oint seam onto the bottom, secure its four corners and thencarefully and uniformly press the outer race of the 4ring into the seal groove along the straight portion

of the moulding, alternately press in the inner race of the 4ring until they closely and uniformly adhereto. 3n this case, you can close the door and the device enters into the operation state.

/hen installing the O%ring" i* there is assistance )rovided =y the other )erson" the

installation +ill =eco!e !uch easier

$. 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.1 he 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 pointis 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 scre6in it in the clock6ise direction to

increase the pressure alarm pointJ on the contrary, scre6out it in the anticlock6ise direction to lo6er the

pressure alarm point.

2 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 one6ay valve, the vacuum pump and theexternal pipeline.

O 4ne6ay valve= This valve is a straightthrough type check valve, and the exhausting of gas from thesterilization chamber under the programcontrolled 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 oilfree vacuum pump, and main device for vacuumizing. This pumpfeatures small volume, lo6 noise, fast vacuumizing speed, and easytoinstall.

$ he 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 builtin gas /ar. The liquidstate ethyleneoxide is fully vaporized under the carburetor?s heating function, and then enters into the sterilizationchamber.

O Carburetor= The carburetor is cuboidshaped, 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 inorder to control the 6ork of electrical bar.

2'

-otice


21/48

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

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

4 &ir )i)eline

The sterilization chamber?s inlet pipeline is located at the lefthand 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 finallyenters 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."m, and the filter can filtrate the bacteria and foreign materialsfrom the air. The service lifetime of filter element is one year, and it shall be regularly replaced.

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

6 he distilled +ater )i)eline

The distilled 6ater in the 6ater storage tank flo6s through the humidifier pneumatic valve, and is heatedin 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. 4 B4T use thecommon tap 6ater as the humidifying 6ater, other6ise it may result the blockage of pipeline.

Sensor asse!=ly

This series sterilizer equips 6ith the pressure sensor, temperature sensor, humidity sensor and other

inspection components, 6hich are used to realtime examine the 6orking condition of the sterilizer.O $ressure sensor= 3t equips 6ith a high precision pressure transmitter system, and converts thesterilization 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=

#atm#0#.(k$a#.0#(bar#0#(mbar'50mmFg

O Temperature sensor= 3t uses the platinum thermal resistance :$t#00;. $lease refer to the control systemfor 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?stemperature.

O Fumidity sensor= The selected humiditysensitive 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, C display, miniprinter, pressure transmitter and soon.

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 compactstructure, 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

/arin


22/48

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

O 9M"(%= +nalog input conversion module, 6hich is applicable for the analogtodigital 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 analogtodigital 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 "28C po6ered, t6o6ire

system, integrated transmitter 6hich converts the signals from the platinum thermal resistance to theelectrical signals.

a.4perating principle= The temperature sensor is affected by the temperature and then generates theelectric 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 voltagecurrent 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 longterm

stability, maintenancefree.

he ground +ire o* control )anel !ust =e relia=ly earthed" other+ise it !ay resultthe u!) o* te!)erature and )ressure

O $ressure transmitter= The pressure signal is converted to 2 "0m+ electric current signal, and thenchanged 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 theresistance 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 to9M"(#, 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 thetouch screen as the humanmachine interface. 3n the control system, the temperature and pressure signals

are acquired 6ith the &39M9B&?s standard module= The temperaturemeasuring 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 thepressure 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 thetemperature and pressure during sterilization process can be realtime measured by the programmable

logic controller and displayed on the humanmachine interface and the programmable logic controller is

net6orked 6ith the computer in order to fulfill the monitoring of upper computer and store someimportant data into a database for archivekeeping and future reference.

1or the actual operation, all parameters must be ad/usted and preset according to the sterilizationrequirement 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.


23/48

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

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.

2$

/ari


24/48

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

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 andstandards 6hen the ethylene oxide sterilizer leaves factory.

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.

2 Co!!issioning o* co!)ressed air

Turn on the po6er s6itch, and then press do6n the &T+7T button. >hen the pressure of compressed airinside 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. +fter6aiting 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 tothe 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 drainoutlet shall be manually opened in order to drain out the condensed 6ater.

$ 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 the6ater 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.4 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.

he heating !e!=rane co!!issioning is used only +hen the heating *ault

a))ears. Caution" scald

6 ChecD +hether all valves o)erate

24

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25/48

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

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.

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 thesterilization 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.

26

8lease select the sterilization te!)erature

ro ra!

''4

6sterilization )rogra!

''4

$7sterilization )rogra!


26/48

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

O)erating Menu 2

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.

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 C4&9 position shall be successfully inspected.

2

Ethylene Oxide Sterilizer

9quipment operate program

4pen front door close front door

inner chamber temperature= inner chamber pressure=

inner chamber humidity

8ro ra!

3n ut o erator

3nput ventilationmi

trend

trend

report

report

return to )revious )age.

/ari


27/48

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

72727272

7272

7272

7272

7272

7272

7272

7272

7272

7272

7272

72727272

7272

72727272727272727272727272727272727272727272727272727272727272727272727272727enteren

and Aentilation i!e. he 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 $2%$ 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.

27

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28/48

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

O)erating Menu 4

O)erating Menu 6

. $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.

23

n)ut

M007

3nvalid pass6ord, please input

7eturn confirm

Equipment Numbers,XG2.@C0%1$'

Syste! !aintenance

7etT00-

Change

$ass6ord

systemsettin s

3nput manual output

Equipment


29/48

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

O)erating Menu

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

##0if out of range.

Touch the KefaultL button on the 4perating Menu 5, all parameters 6ill restores to the default

parameters 6hen leaving factory.

7. 66)rogra! heating +all te!)erature setting3n 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.

O)erating Menu 7


a The input range of cabinet upper 6all temperature is %" 5(, and it restores to the default value

2B

$7+all te!)erature settings

Cabinet upper

Cabinet lo6er

1ront door heating

vaporization heating

default return to previous

66+all te!)erature settings

Cabinet upper temperature

Cabinet lo6er temperature

1ront door heating

vaporization heating

return to previousdefault


30/48

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

()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

##0if out of range.

Touch the KefaultL button on the 4perating Menu ', all parameters 6ill restores to the defaultparameters 6hen leaving factory.

3. e!)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.

O)erating !anual 3


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 tothe 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 KefaultL 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.

$'

Temperature rising speed

settings

Upper arm temperature rise speed=

o6er arm temperature rise speed=

1ront door heating temperature

s eed=

8aporization heating temperature

s eed=

default


31/48

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

O)erating !anual B


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 outof 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. 3nthe 4perating Menu #0, set the system time.

O)erating !anual 1'

Setting !ethod,

a 3n the K&et the clockL column, input the time to be modified.

$1

return to previous

8acuum speed settings

8acuum time limit=

8acuum return time limit=

8acuuminizing time interval=

default

&

&

&

Clock settings

Current

&et the

default return to previous page

yy,mm,dd,h,m,


32/48

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

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.

O)erating !anual 11


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 Kigital inputL column behind the letter to modify thecorresponding parameters.

$2

$rinting settings

$rinter status

Curve print

7eport print

sApixel

sApixel

default return to previous page

T4penAclose


33/48

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


O)erating !anual 12

O)erating !anual 1$

8ara!eter descri)tion

a The input range of inner chamber temperature, bottom temperature, top temperature, front doortemperature, 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 tothe 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.

$$

&ystem parameter

inner chamber temperature

lo6er chamber temperature

calibration

upperr chamber temperature

front door temperature

vaporization temperature

calibration

next return page

&ystem settings

3nner chamber pressure

3nner chamber at zero position

3nner chamber humidity

door opening time limit

door closing time limit

obstacle alarm time

mbar

mbar

H

s

s

s previous


34/48

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

1$. reat!ent o* goods to =e sterilized and )recautions

1. 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.

2. Lu!idity assurance

+ certain humidity is necessary to the ethylene oxide sterilization. o6 humidity may affect sterilizationeffect. 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 prestored

in the environment of (%H 7.F., 6here %0H 7.F. is preferred. The sterilizer can humidify the goodsduring the pretreatment 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. he 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.

$. Goods )acDage


35/48

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

he 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. o 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.

2 (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.

$ Con*ir! the gas ar


36/48

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

A. 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.


37/48

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

"; 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 4peratingMenu #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 1

>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 the4perating Menu #%. 3n the 4perating Menu #%, initialize all parameters of the system setting.

$7

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 4peratingMenu #). 3n the 4perating Menu #5, edit all parameters of ('or %%program.

O)erating !anual 13

To edit the ('sterilization program, touch the K('sterilizationL and then enter into the 4peratingMenu #-.

To edit the %%sterilization program, touch the K%%sterilizationL and then enter into the 4perating

Menu "0.

O)erating !anual 17

$3

$rogram editing

7eturn

('sterilization %%sterilization


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O)erating !anual 13

8ara!eters descri)tion,

1 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.

2 8ulsation vacuu! u))er li!it

3t means the maximum control pressure of inner chamber vacuumreturn 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.

$ 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.

4 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.

6 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.

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.

7 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 #)0min500min is set, and it restores to its initial value #)0min if out of

range.

%%program=The range of 50min500minis set, and it restores to its initial value 50min if out of range.

3 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.

B &ir ventilation ti!e

3t means the time at the ventilation residualremoving 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 ofthe device.

&lar! !enu

4'

+larm menu

Yuit alarm confirm


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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@

. Co!!on trou=leshooting

uring the device running process, some unanticipated special events unavoidably happen. &ome

problems and its corresponding troubleshooting are summarized as follo6s.

41


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S:

-

8ro=le! descri)tion &lar!

code

rou=leshooting

# ong door opening or closing time +# +" #; Check 6hether the door opening or

closing limit s6itch is misplaced or faulty

"; +ppropriately enlarge the dooropening or closing limit in the &ystem

parameters setting

" oor 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

2 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 andvacuum return pipeline, and 6hether it

has leak.

5 $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 vacuumreturn 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


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## 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 selfprotection 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 sterilizedThe 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 ( Z2 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 byextending 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.

2 Environ!ent o* sterilization roo!

O The floor of sterilization room must be even and smooth, and the operation area must be kept clean anddry. 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 asthe 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 greatlyimprove the 6orking condition of the sterilization room.

$ 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 innerchamber in order to let the ethylene oxide gas to smoothly circulate.4$

notic


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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, placeit absolutely according to the papertoplastic 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 sterilizationmethod 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.

1 )hysical !onitoring

The physical monitoring is mainly to reflect the status of sterilizer, and means 6hether the sterilizer?s allkey 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 relativehumidity 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 determine6hether 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.

2 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, simpleand 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 thesterilized and nonsterilized goods, and the commonlyused 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 thechemical 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.

he 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 range

$ =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

notic


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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 sterilizationformulated 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 sterilizationformulated by the Ministry of Fealth of the $eople?s 7epublic of China, asthe 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 intothe 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 reexamine the sterilizer?ssterilization 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, sterilizationtemperature, 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 thenculture the!.

The physical examination, chemical examination and biological examination methods have its o6ndifferent 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 devic

pure eto gas manual-1

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