Getinge GEE User manual

BAX001 . . . . . GEE General

Ethylene oxide is a poisonous and explosive agent. This manual therefore has to be thoroughly studied before the sterilizer is put into operation!

BAX002 . . . . . All manuals

Attention symbols

Some of the war nings, instruct ions and advice in this manual are so important that we used the following special symbols to draw attention to them:

Warnings

This symbol indi cates a wa rning . Injury or even death may result if you do not heed it. This symbol is also used to mark out safety components etc. See section ”Safety devices, a survey” in chapter ”Introduction” in the OPERATOR MANUAL or chapter ”Maintenance” in the SERVICE MANUAL

Instructions

Advice

This symbol indicates instructions which are important, for example to preve nt damage to the sterilizer an d/or the load

This symbol indicates important advice and hints that make it eas ie r to work with the sterilizer.

INTRODUCTION

CAX016 . . . . . GEE General

Introduction GEE

The GETINGE sterilizer type GEE is intended for sterilization of heat sensitive goods which may be damaged by the temperature in a conventional steam sterilizer. The active sterilizing agent is ethylene oxide, used in a process at temperatures about 50 oC.

The sterilizing agent is stored in liquid state under pressure in gas bottles. The liquid ethylene oxide is transformed into gas in a heated evaporator before it enters the sterilizer chamber.

Both the sterilizer chamber and the door(s) are equipped with jackets in which temperature controlled water is circulated. This keeps chamber walls and door(s) at a uniform temperature, thereby preventing condensate from forming on the walls.

A computerized control unit, thoroughly described in a separate section of this manual, controls the process from start to end. The operator will not be able to alter any variables in the control unit program while a process is in progress.

Parameters such as jacket and chamber temperature as well as elapsed sterilizing time may be displayed by the operator at any time during the process.

CAX017 . . . . . GEE - Explosion proof

Owing to t he g eneral dangerousn ess of t he sterilizi ng agen t, some ster ilizer main compone nts are placed in separate rooms, diff erently classified with regard to the risk of explosion. The sterilizer pressure vessel with its executing components and the gas bottle storage room are classified as explosive area. Electric components in this area therefore are of the explosion proof type.

Electric temperature sensors are equipped with zener barriers while valve actuators and signal transmitters are of the pneumatic type in this zone. To enable for the pneumatic signals to be processed by the computer, they are converted outside the explosive area to electric signals.

CAX018. . . . . . GEE General

Guidelines of using ethyl ene oxid e as sterilant

Ethylene oxide properties

Ethylene oxide has its boiling point at 10,7 oC (51,3 oF) at atmospheric pressure and is at room temperature a colourless, flammable gas which is somewhat heavier than air.

Ethylene oxide is characterized by being readily reactive with many chemicals, soluble in most organic solutions as well as solid state organic materials and completely soluble in water at 10 oC (50 oF).

Polymerization of liquid state ethylene oxide is initiated at room temperature by acids, bases or such catalysts as dehydrated metal chlorides or -oxides. Rust may consequently serve as a polymerization starter. The polymerization is associated with a considerable heat production. Uncontrolled rise of the temperature may result in evaporation of ethylene oxide and ultimately risk of explosive decomposition. A temperature rise of a few degrees only may be indicative of risk of polymerization.

In contrast to the liquid state of ethylene oxide, which is relatively stable to detonating agents, gaseous ethylene oxide is highly explosive and flammable when mixed with air. Gaseous ethylene oxide in air is readily ignited by an electric spark, sta tic electricity, an open flame or by similar means. If heated to 571 oC (1059,8 oF) in the absence of air or oxygen , ethy lene o xide vapour will dec ompose wi th exp losive violence. In an air mixture self ignition takes place at 429 oC (806 oF).

The health hazards when handling ethylene oxide are many.

In gaseous state the agent affects the mucous membranes already

•

below 100 ppm. The lower odour detection limit for ethylene oxide is as high as about

•

700 ppm and for this reason it can not serve as a risk-indicator for human exposition. Ethylene oxide has a fatiguing effect on the organs of smell even at low concentrations.

For higher concentrations one feels sick with long periods of vomit-

•

ing. The gas also works narcotically. At high gas concentrations the cornea of the eye may be injured as

•

well as the mucous membranes of the throat and the pulmonary alveoli.

After repeated contact there often appear an allergic hypersensitive-

•

ness.

• Severe inhalation poisoning causes, besides sickness and vomiting

also mental aberration, weakness, cramp, difficulty in breathing, unconsciousness and occasionally pulmonary oedema.

• Ethylene oxide in liquid state is eating and causes b listers on the skin.

The eating is not immediate but longer contact time causes deeper tissue decomposition.

• Liquid ethylene oxide is one of the most destructive agents to eyes.

• Ethylene oxide solved in water to 40-80% will cause more severe

injuries than pure ethylene oxide. This circumstance has caused eat injuries on the human body on spots where ethylene oxide has dissolved in perspiration.

• Ethylene oxide is a readily reactive agent and an efficient solvent

which must be taken into consideration when selecting material for articles and wrapping which are to be sterilized in this medium.

· Carbon steel, stainless steel, glass, rubber, acrylic, polyamide,

PVC, PTFE and polythene are not affected by ethylene oxide during the sterilization.

· Rubber, leather, polythene, polymetylmetacrylate and PVC may

absorb small quantities ethylene oxide which can be removed by exposing the goods to vacuum for some time.

· Packing material like paper, wood, cotton, paint, ink and enamel

is usually unaffected by the gas.

ETO- steri li zation gene rally

The reason for the very rigorous directions for use and handling of ethylene oxide is that the substance, which from several points of view is very dangerous also in low concentrations, can be spread to the work area by a ccident, carelessnes s, unexpect ed malfunction of the equipment etc.

In the daily use of a gas sterilizer no gas escapes to the operato premises. The only occasion when very small quantities may be detected close to the sterilizer is when the sterilized goods is taken out from the chamber, because some of the material has absorbed a certain quantity of gas. No matter how small the amount might be, it must never be neglected.

Ethylene oxide is po isonou s, exp losi ve, canc ero genic and suspiciously mutati ng.

GETINGE AB has devoted great care in the design of the ethylene oxide sterilizer in order to obtain entire personal and material safety, not

only in the regular use of the sterilizer, but also in such extraordinary situations as can reasonably be predicted.

An indispensable condition in achieving the safety aimed at, is that the written advise regarding installation and operation of the sterilizer and accessory equipment is strictly followed and that its original technical performance is maintained by regular service as long as the steri lizer is in use.

There is concentrated ethylene oxide in:

THE GAS CYLINDER

The ethylene oxide is stored as a liquid under pressure in gas bottles or cylinders, each one containing a gas quantity sufficient for several sterilisation processes.

THE STERILIZER CHAMBER AND EVAPORATOR

The ethylene oxide is withdrawn from the cylinder not until a defined stage in the sterilization process is reached. The fluid ethylene oxide is converted into gas state in a heated evaporator before it enters the sterilizing chamber.

THE VACUUM PUMP AND THE EXHAUST SYSTEM

After the gas has influenced the goods for a stipulated time, it is pumped out of the sterilizer chamber by a water ring type vacuum pump. The gas is collected in a tank which also holds the recirculating sealing water for the pump. Gas and water are separated in the tank from which the gas is lead through an exhaust pipe to a destruction unit or into the open air. The exhaust pipe must, if led into the open air terminate minimum 3 m above ground level at a minimum distance of 7,5 m from human whereabouts, windows, air intakes etc.

There is ethylene oxide residuals in:

THE SEVICECOMPARTEMENT

During the humidification stage, steam is admitted to the chambe where it condensates. This increases the water content of the tank why the excess water is allowed to escape through an overfl ow wit h g a s trap. This escaping water contains solved ethylene oxide which continuously evaporates. Close above the floor drain should therefore be arranged a ventilation hood, sized so as to be able to ventilate the whole service compartment with an air change of 10 times per hour. The air inle should be placed near the ceiling.

THE UNLOADING SIDE ROOM

In spite of the use of an efficient post-treatment process there remain unacceptable gas quantities in the sterilized goods. The goods has to be

degassed for a period of time which depends on the type of material in goods and wrapping as well as the ambient temperature. The air should, in this room, be changed 10 times per hour in diagonal direction from the ceiling towards the floor, so arranged that the air is moved away from the operator. With this arrangement, airing the goods for a longer period of time is allowed to take place in the same room as the unloading side of the sterilizer.

Ethylene oxide free is:

THE LOADING SIDE ROOM WITH DOUBLE ENDED STERILIZERS

Under regular operating conditions, there is no free ethylene oxide present in this room. There are however the same requirements on the ventilation here as on the unloading side, because if a process has to be aborted, access to the goods has to be gained from the loading side. (Only sterilized goods should be handled on the clean side).

Ventilation system

Exhaust from different rooms has to be made through a separate ventilation system. Alternatively the exhaust could be connected to an existing ventilation system, prov ided this does not wor k according to the recirculation principle.

Work-room

Warnin g posters

Gas storage

Start of a sterilization process should be blocked as long as the ventilation system is not working.

Any room opened for ethylene oxide sterilization should be used exclusively for this purpose and must not be used as a common working area or be u tilize d as a bre ak-room for employee s. Post ed not ice should allow authorized personnel only admission to the sterilizer room.

At the entrance or door to rooms where ethylene oxide is handled, a warning poster with information about the kind of room-activity should be posted. The sterilizer should be equipped with poster(s) informing about risk- , handlin g- and pro tectiv e in structio ns a ccordi ng to local rules.

Not more g as than the every-day need sh ould be stored in the room where the sterilizer is situated. For storing larger quantities of gas cylinders or bottles, take advice from the local fire authorities.

Requirement on the operator

The ethylene oxide sterilizer must be operated by specially educated personnel only. The education should besides the ”push button information” comprise:

• General information about ethylene oxide properties

• Knowledge about the sterilizer principle function

• Knowledge about the ventilation system

• Knowledge about the symptoms at the beginning of an ethylene

oxide poisoning

• First aid to an ethylene oxide exposed person

• Measures in case of an ethylene oxide leak

• Knowledge about how to fight an ethylene oxide fire

Data for fire fighting

Explosive mixture with air 2,6-100% of volume

•

• Ignition temperature 429

C (806 oF)

• The gas is somewhat heavier than air

In case of accidents

•

Do not use open flame

• Smoking is not allowed

• Use sparkless tools and explosion proof electric equipment

Leaks

• Make tight if possible

• Use atomizing water nozzle to damp formation of gas

• Drains should be covered and floors below the sterilizer floor evac-

uated

Fire

• Keep the gas bottles cool by spraying atomized cold water if they are

in a fire

• Do not extinguish burning gas if it is not absolutely necessary

• Extinguish with atomized water or powder if absolutely necessary

First aid

• Rinse eyes in copious quantities of water for at least 15 min. if the

agent has come in contact with the eyes

• Pull off contaminated clothes

• Wash contaminated skin with copious quantities of water

• Do not apply artificial respiration

• Call for a doctor when symptom arise which could result from con-

tact with ethylene oxide in eyes or on skin

The sterilization gas

The sterilant is a mixture consisting of:

CAX042 . . . . . GEE General

Ethylene oxide as a sterilizing agent

Properties of ethylene oxid e

Ethylen e oxi de boi ls at 10.7°C at a tmospher ic press ure an d at room temperature is a colourless and combustible gas which is slightly heavier than air.

Ethylene oxide is characterised by r eactivity wit h many che micals, solubility in most organic solutions as well as in organic solids and complete solubility in water at 10°C.

The polymerisation of ethylene oxide in liquid form is initiated at room temperature by acids, bases or catalysts such as dehydrating metal chlorides or oxides. Rust can consequently give rise to polymerisation. The polymerisation is associated with significant heat production. A rise in temperature of just a few degrees may be a sign of a risk o polymerisation.

Unlike ethylene oxide in liquid form, which is relatively stable in relation to explosion initiators, gaseous ethylene oxide which is mixed with air is extremely explosive and combustible. Gaseous ethylene oxide is readily ignited by electric sparks, static electricity, naked flames etc. If ethylene oxide is heated to 571°C in the presence of air or oxygen, the ethylene oxide vapour disintegrates explosively. Spontaneous ignition occurs in an air mixture at 429°C.

The handling of ethylene oxide poses many health hazards.

• In gaseous form the substance already affects the mucous mem-

branes at concentrations below 100 ppm.

• The lower odour limit for ethylene oxide is very high - 700 ppm - and

therefore cannot be used as an indicator of exposure hazard. Ethylene oxide strains the olfactory organs even at low concentrations.

• People exposed to higher concentrations suffer from nausea and

vomiting over long periods. The gas also has a narcotic effect.

• At high ethylene oxide concentrations the cornea of the eye, the

mucous membranes of the throat and the alveoli of the lungs may be damaged.

• Allergic hypersensitivity often occurs after repeated contact.

• Severe poisoning through inhalation in addition to nausea and vom-

iting also causes mental confusion, a state of weakness, convulsions, respiratory difficulties, unconsciousness and in some cases pulmonary oedema.

• Ethylene oxide in liquid form is corrosive and causes blisters on the

skin. The corrosive reaction does not occur immediately, but prolonged contact leads to disintegration of the deeper tissues.

• Ethylene oxide in liquid form is an extremely hazardous substance

for the eyes.

• A 40 percent aqueous solution of ethylene oxide causes more severe

damage than pure ethylene oxide. Corrosive damage has occurred in cases where ethylene oxide has been dissolved in sweat.

• Ethylene oxide is an extremely reactive substance and an effective

solvent, which must be borne in mind when choosing the material of items and packaging sterilized in this medium.

· Carbon steel, stainless steel, rubber, acrylic, polyamide, PVC,

PTFE and polyethylene are not affected by ethylene oxide during sterilization.

· Rubber, leather, polyethylene, polymethyl methacrylate and PVC

may absorb small quantities of ethylene oxide, which can be removed by keeping the material under vacuum for a time.

· Packaging materials such as paper, wood, cotton, paint, ink and

enamel are generally not affected by the gas.

General information on ETO sterilization

The reason for the extremely strict instructions on the use and handling of ethylene oxide is that this substance, which is many ways is very hazardous even at low concentrations, may be spread within the workroom by accident, through carelessness, unexpected equipment faults and so on.

No discharges of gas in the operator room occur in the daily operation of a gas sterilizer. The only occasion when small quantities of gas may be detected close to the sterilizer is when the sterilized items are removed from the chamber, as the material may have absorbed a certain

amount of gas. Regardless of how small the quan tities in volved are, they must never be ignored.

Ethylene oxide is toxic, explosive, carcinogenic and suspected of causing mutations.

GETINGE AB has put great emphasis on personal and material safety in designing the ethylene oxide sterilizer, not just with routine operation in mind but also to deal with exceptional situations that can be reasonably predicted.

It is an essential requirement, for the intended level of safety to be achieved, that the writ te n instru cti ons for installation and ope ration o f the steriliz er and add itional equipment are strictly complied with and that technical performan ce i s main tai ned by re gula r s erv icin g duri ng t he time the sterilizer is in use.

There is concentrated ethylene oxide in:

THE GAS CONTAINER

Ethylene oxide is stored in the form of liquid under pressure is gas bottles or cylinders, which contain a quantity of gas sufficient for several sterilization processes.

THE STERILIZATION CHAMBER AND THE EVAPORATOR WITH ASSOCIATED PIPE SYSTEM

Ethylene oxide is not taken from the cylinder until the sterilization process has reached a particular point. Liquid ethylene oxide is gasified in a heated evaporator and is then conveyed into the sterilization chamber.

THE VACUUM PUMP AND THE OUTLET SYSTEM

After the gas has acted on the items for the specified time, the gas is pumped out of the sterilization chamber by a vacuum pump of the water-ring type. The gas is collected in a tank which also contains the circulating sealing water for the pump. Gas and water are separated in the tank and the gas is conveyed through an outlet pipe to the cleaning unit or outside the building. The mouth of an outlet pipe discharging into the atmosphere must be at least 3 m above ground level and at least

7.5 m from areas where people spend time or where there are windows, air intakes and so on.

There are ethyle ne oxide residues in:

THE SERVICING ROOM

During the moistening phase vapour is released into the chamber. The vapour condenses on the load until the load has reached the correct tem-

perature. This increases the liquid level in the gas separator tank. This liquid contains ethylene glycol and dissolved ethylene oxide which continuously evaporates. Liquid is drained off from the tank when the liquid level becomes too high. The tank is emptied through the valve in the bottom.

This liquid must be disposed of in accordance with local safety regulations.

Because of the potential risk of leaks, the whole servicing room must be ventilated, with the air changed at least 10 times an hour. The extraction point must normally be located at the floor drain and the air intake close to the ceiling.

THE UNLOADING ROOM

Despite an effective post-treatment process, unacceptable quantities of gas remain in the sterilized items. The items therefore have to degassed during a time which depends on the type of item and p ackaging concerned and the ambient temperature. The complete quantity of air in the room should be changed 10 times an hour in a diagonal direction from the ceiling to the floor so that the air moves in the direction away from the operator. With this arrangement it is permissible to air the items for a longer time in the room serving as the discharge side for the sterilizer.

There is no ethylene oxide in:

THE CHARGING ROOM (STERILIZER WITH TWO DOORS)

Under normal operating conditions there is no free ethylene oxide in this room. The ventilation requirements are nevertheless the same as on the discharge side, as the items have to be handled from the charging side if the process stops. (Only sterilized items may be handled on the clean side.)

Ventilation system

The discharge from different rooms must be conveyed via separate ventilation systems. The discharge can alternatively be connected to an existing ventilation system, provided this operates according to the recirculation principle.

The start of the process must be blocked for the time the ventilation system is not working.

Workrooms

The rooms used in connection with the ethylene oxide sterilization must be dedicated to this purpose, and must not be used as general workrooms or rest rooms for t he personnel. A notice stat ing that only authorized personnel have access to the sterilizer room must be posted up.

Warning notice

A warning notice must be posed up at the entrance or on the doors to the rooms where ethylene oxide is handled, containing information on the type of activity taking place in the rooms. The sterilizer should be provided within one or more notices containing hazard, handling and protection instructions in accordance with local regulations.

Gas storage

No more gas than is required to meet the daily requirement may be kept in the sterilizer room. Local fire safety authorities must be consulted on the storage of larger quantities of gas cylinders or bottles.

Requirements to be met by the operator

Only specially trained personnel may handle the ethylene oxide sterilizer. The training must go further than "press the button" information and cover the following:

• general information on the properties of ethylene oxide

• knowledge on the basic function of the sterilizer

• knowledge on the ventilation system

• knowledge on the symptoms of incipient ethylene oxide poisoning

• first aid for persons exposed to ethylene oxide

• action to be taken in the event of an ethylene oxide leak

• knowledge on how to control an ethylene oxide fire

Firefighting information

Explosive mixture with 2.6-100% a i r

•

• Ignition temperature 429°C

• The gas is slightly heavier than air.

If an acciden t happ ens

Do not use a naked flame

•

Leaks

• Smoking is prohibited

• Use non-sparking tools and explosion-proof electrical equipment

Seal the leak if possible

•

• Stop the formation of gas using water through a nozzle

• Cover the outlets and evacuate the storeys of the building below the

floor of the sterilizer room

Fire

• If the gas bottles are exposed, cool them by spraying cold water

• Do not extinguish burning gas unless absolutely necessary

• If it is necessary to extinguish, use sprayed water or powder.

First aid

• If the agent has entered the eyes, rinse with very copious amounts of

water for at least 15 minutes

• Take off clothes contaminated with gas

• Wash exposed skin with very copious amounts of water

• Go not give artificial respiration

• Contact a doctor if symptoms occur which may be due to ethylene

oxide having come into contact with the eyes or skin

Sterilization gas

The sterilizing medium is a mixture of:

CAX019. . . . . . 10/90 ETO/CO2

10% ethylene oxide C2H4O 90% carbon dioxide CO2

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 51 bar (740 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX023. . . . . . 20/80 ETO/CO2

20% ethylene oxide C2H4O 80% carbon dioxide CO

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 49 bar (700 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the

bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX025 . . . . . 30/70 ETO/CO2

30% ethylene oxide C2H4O 70% carbon dioxide CO

The gas m ixture is stored as a liquid in gas bottles with a pressure about 40 bar (600 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX027 . . . . . 90/10 ETO/CO2

90% ethylene oxide C2H4O 10% carbon dioxide CO

The gas m ixture is stored as a liquid in gas bottles with a pressure about 7 bar (100 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consul t your gas su pplier regarding how to place the bottle to ensure that only the liquid stage is withdrawn from the bo ttle.

CAX029 . . . . . 10/90 ETO/Freon

10% ethylene oxide C2H4O 90% dichlorodifluoromethane CCl2F

The gas m ixture is stored as a liquid in gas bottles with a pressure about 4 bar (60 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the

bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX031. . . . . . 12/88 ETO/Freon

12% ethylene oxide C2H4O 88% dichlorodifluoromethane CCl2F

The gas mixtu re is stored as a li quid in gas bo ttles wi th a pressure about 3,5 bar (51 psig) at room temperature. The gas has to be taken out as a liquid which usually is done via a dip pipe from the bottom of the bottle. This arrangement calls for an upright position of the bottle while withdrawing the gas.

Consult your gas supplier regarding how to place the bottle to ens ure tha t only t he liq uid stage is withdrawn from the bottle.

CAX020. . . . . . GEE general

It is important that the sterilant is withdrawn as liquid from the containers and that the liquid is completely vaporised prior to introduction of the vapour into the sterilizing chamber. The mixture fed into the sterilizing chamber will then have the specified ethylene oxide content and the dangers associated with flammable vapours will be re du ced.

CAX021. . . . . . 10/90 ETO/CO2

If, on th e other han d, vapour is withdrawn from the contai ner top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, since CO2 being the more volatile component. Such vapour will have reduced steri lizing propert ies since t he propor tion of eth ylene ox ide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 10% and hence will be more flammable.

CAX024. . . . . . 20/80 ETO/CO2

will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 20% and hence will be more flammable.

CAX026 . . . . . 30/70 ETO/CO2

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, carbon dioxide being the more volatile component. This vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 30% and hence will be more flammable.

CAX028 . . . . . 90/10 ETO/CO2

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more carbon dioxide than the liquid, carbon dioxide being the more volatile component. This vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the cont ainer will h ave an ethy lene oxid e con tent in e xcess of 90%.

CAX030 . . . . . 10/90 ETO/Freon

If, on the other hand, vapour is withdrawn from the container top, fractioning of the two components of the mixture will take place and initially the vapour will contain more dic hlorodifluoromethane tha n the liquid, since CCl2F2 being the more volatile component. Such vapour will have reduced sterilizing properties since the proportion of ethylene oxide will be reduced. As evaporation of the liquid progresses the remaining liquid will be enriched with ethylene oxide and ultimately the vapour off-take from the container will have an ethylene oxide content in excess of 10% and hence will be more flammable.

CAX032 . . . . . 12/88 ETO/Freon

CAX022. . . . . . GEE general

The pressure within a container gives an inaccurate information about the quantity of liquefied gas held by the container. The only satisfactory way of checking the contents of cylinders and drums is by weighing, and this method should be used to determine whether a container is empty. A simple means to get continuous informat ion about the ga s content of the bottle is to keep it standing on a scale while withdrawing the gas.

The gas bottle storage room has to be well ventilated with change of air at least ten times per hour in the direction from ceiling towards floor.

CAX002. . . . . . GEC general

Introduction GEC

Sterili zer type GEC is the coll ective desi gnation of a ra nge of GETINGE high pressure sterilizers usi ng c irculating process water as heat transfer media. GEC-sterilizers are available with vertically or horizontally sliding automatic doors. Both single and double ended types exist.

The GEC-sterilizers are intended for sterilization of liquids contained in pressure tigh t glass or plastic containers which resist pouring with water. If the sterilizer is equipped with a vacuumpump it may also serve as an ordinary steam sterilizer suitable for sterilization of utensils, containers, textiles etc.

Adaptation to respectively task is made mainly by selecting type of software for the control unit. The sterilizer control unit is computerized and provides possibilities for a large number of processes, all characterized b y a very go od acc uracy in c ontrolling the p rocess p arameters.

Both instantaneous and set values for a proceeding process may be displayed on request.

The software which controls the processes can be fixed programmed in the control unit to combine quickness with safety in the production lines. When it comes to odd type of works, most process parameters can be set from time to time by the operator. Reprogramming of the control unit can be made at site.

The automatic doors are provided with safety devices to protect the operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel and, for vacuum-cycles, as a steam jacket containing temperature con trolled steam heating for the chamber walls.

The GEC-type steri lizers should be sup plied with el ectrici ty, cold water, process water, compressed air and steam. If central steam is not avai la b le o r t h e r e are rea son s not to use i t , sma l l GEC-u nits can be equipped with an electric steam generator.

CAX014 . . . . . GEV general

Introduction GEV

The GEV sterilizer is characterized by one or more ventilators, arranged at the sterilizer chamber ceiling, to keep the chamber atmosphere in violent circulation.

The utilized compartment is made of comparatively thin stainles steel sheet and is centrically located in a surrounding pres sure v essel. The space between the utilized compartment and the pressure vessel is filled at each sides with a pack of tubes which are flown through by cold water, or in some cases by steam.

The ventilators make the chamber atmosphere pass through the pipe pack in direction from the ceiling towards the floor, thereby being cooled or heated depending on the medium passing through the pipes.

The flow through the load will consequently go in the dire ction from below and upwards.

The special feature of the ventilator sterilizer renders it unique properties. Besides the sterilizer functioning as a common steam sterilizer, it also works excellent with support pressure, created through the admission of compressed air into the chamber. The turbulent flow caused by the ventilators will efficiently homogenize the chamber atmosphere so as to create a uniform temperature all over the chamber. Without the ventilator stirring effect a stratification between steam and air would easily take place with big temperature gradients as a consequence.

Sterilizing products being sensitive to moisture can be treated in ventilator sterilizers which are heated by steam passing through the packs of pipe. The heat produced is transferred to the goods when the ventilator circulates the air trapped in the chamber. The process can be complemented with support pressure created by compressed air.

The principle described in the paragraph above is also used as a drying procedure, for instance if an extremely dry load is required after a steam sterilization.

By letting cold water through the pipe-pack an efficient cooling of the load will be obtained. Also the cooling process can be complemented with support pressure created by compressed air.

CAX035. . . . . . GEVC general

Introduction GEVC

Sterilizer type GEVC is the collective designation of a range of GETINGE high pressure sterilizers capable of using either circulating process water or circulating air as heat transfer media. GEVC-sterilizers are available w ith vertically or horizon tally sliding autom atic doors. Both single and double ended types exist.

The GEVC-sterilizers are designed for sterilization of most types of

products. The sterilizer can run both GEC-cycles and GEV-cycles.

GEC-cycles are often intended for sterilization of liquids contained in pre s s u r e tigh t g l a s s or plast i c conta i ners whi c h resist p o ur i ng with water. In this case circulating water is used as heat transfer media. A centrifugal pump is used for circulating the water.

GEV-cycles are used when the re is a d emand for a package for the product. Also this type of cycles can be used for sterilization of liquids in sealed containers. For GEV-cycles air and steam are used as heat transfer media. One, or several, fans are used to keep the chambe atmosphere in violent circulation.

If the sterilizer is equipped with a vacuumpump it may also serve as an ordinary steam sterilizer suitable for sterilization of utensils, containers, textiles etc.

Adaptation to respectively task is made mainly by selecting type of software for the control unit. The sterilizer control unit is computerized and provides possibilities for a large number of processes, all characterized by a very good accuracy in controlling the process parameters. Both instantaneous and set values for a proceeding process may be displayed on request.

Reprogramming of the control unit can be made at site. The a utomatic doors ar e provided with safety devi ces to protect the

operator.

The GEVC-type sterilizers should be supplied with electricity, cold water, process water, compressed air and steam. If central steam is not available or there are reasons no t to use it, smal l GEVC-units can be equipped with an electric steam generator.

CAX015 . . . . . GE Ph.div. general

Introduction GE

Sterilizer type GE is the collective designation of a range of GETINGE high pressure sterilizers using steam and v acuum in the process for ster-

iliz ation. GE-ster ilizers are avai lable w ith v ertica lly or hor izontally sliding doors. Both single and double ended types exist.

The GE-sterilize rs are intended for steriliz ation of materia ls in the health service as well as in the pharmaceutical industry. The type o materials include: instruments, utensils, glass, plastic, leather and textiles. Some sterilizers have special programs for sterilization of hot and cold liquids. The all dominating sterilizing agent is steam with a temperature of 120-135 °C.

Reprogramming of the control unit can be made at site. The automatic doors are provided with safety devices to protect the

operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve

both as stiffening bars for the pressure vessel and as a steam jacket containing temperature controlled steam heating for the chamber walls.

The GE-type sterilizers sho uld be supplied with electricity, cold water, compressed air and steam. If central steam is not available or there are reasons not to use it, GE-units can be equipped with an electric steam generator.

CAH017 . . . . . Introduction to GE sideways-opening, Hospital

Autoclave type GE

Getinge Autoclave type GE is the designation of a series of high-pre ssure autoclaves with horizontal, automatic sliding doors in single-door and double-door versions..

The autoclaves are intended for the sterilization of equipment both in hospitals and industry. Adaptation to the particular functions concerned is done through the selection of control equipment. This is based on a microprocessor and consequently offers a very large number of types of process, all characterized by exception al accuracy in the regulation of the process parameters. The operator can call up on a display information on the current process, current process phase and the actual values of the parameters while the process is in progress.

The totally dominant sterilization medium is steam with a temperature of 121 - 134 °C. Material which is damaged by this temperature may be sterilized, in certain autoclave models, in formalin vapour at 65 - 80 °C.

Mos t types of items ca n be steri lized i n the GE au toclaves , using adapted programs: Instruments, machine parts, glass, plastic, rubber, leather, textiles, cold and hot liquids in open or ventilated containers and small pressure-tight liquid-filled containers of stable shape.

European standard EN 285 specifies the use of fixed programs only. However, the control equipment of GE autoclaves allows the programs to be made variable during the time testing is in progress.

If the autoclave is not covered by European standard EN 285, all the programs are variable.

As door operation is controlled automatically as well as the processes, it is not a long step to automation of the handling of items for sterilization. The control unit is therefore prepared for the control of autoclaves with automatic loader and/or unloader.

As in other Getinge double-jacketed autoclaves, the external surface of the chamber is half-covered with all-welded U-sections. These stiffen the flat walls of the pressure vessel, and at the same time accommodate the steam which keeps the chamber walls warm in order to minimize condensation in the chamber. The design principle means that all welds are available for visual inspection after the thermal insulation has been removed.

A vacuum pump of the water-ring type removes air, steam and condensate from the chamber and door-gasket groove. The sealing wate r of the pump is taken from an open pump which in some cases also supplies the feed-water pump with water on autoclaves with a built-in steam generator.

The condenser between the chamber and the vacuum pump converts waste steam to water. The decrease in volume contributes substantially to increasing the efficiency of pump operation an d protecting the pump and discharge lines against high temperatures.

A well-damped d ischarge system after the vacuum pump and welldimensioned thermal insulation around the chamber mean that the auto-

clave has a minimal effect on the surroundings where it is installed, making it easy to position.

GE autocl aves have to be supplied with ele ctricity, col d water, compressed air and steam. When steam is supplied from a central steam-production plant, its distribution is required to be well insulated and dewatered. The pressure in the line has to be reduced to the correct level and the line has to be fitted with a safety valve. In addition, the steam plant must produce a quality of steam which is suitable in the context of sterilization.

If there is no steam network or there are reasons for not using the steam network, the autoclave can be fitted with a built-in electric steam generator (certain models only) or a stand-alone steam generator which is installed in the service room.

CAX036 . . . . . GED general

Introduction GED

Steril izer type GED is t he collective de signation of a ra nge of GETINGE high pressure disinfection autoclaves using steam and vacuum in the process for disinfection.

The GED operate at the temperature 105 oC, or for heat sensitive goods at 75 oC. In both cases steam serves as a disinfection agent, in the latter case under vacuum. Very heat sensitive material can be disinfected in specially designed GED´s by means of formaldehyde at 65 oC.

Since the process include vacuum stages, the control unit is equipped with a process for automatic leak rate test.

Jacket tempe ratures below 100 oC are enabled by using subat mospheric steam, produced by intermittent evacuation of the jacket.

The processes are based upon the GETINGE principle with pulsating

prevacuum, known for its air purging abilities.

Reprogramming of the control unit can be made at site. The automatic doors are provided with safety devices to protect the

operator.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel and as a steam jacket containing temperature controlled steam heating for the chamber walls.

The GED- type sterilize rs should be supplied w ith electr icity, cold water, compresse d air and st eam. If centr al steam is no t available o there are reasons not to use it, GED-units can be equipped with an electric steam generator.

CAX033. . . . . . GEE general

The sterilizer

The ster ilizer cham ber, made of acid proof stainless steel is covered externally to about half its area by seal-welded u-profiles which serve both as stiffening bars for the pressure vessel, and as a double jacket

containing the medium heating the chamber walls. The design principle makes all weld seams a ccessible for visual inspection after removal of the heat insulation.

The gas sterilant is drawn as a liquid from bottles or cylinder containers. It is converted into a gas in a heated evaporator which is designed to serve also as a cleaner for the gas.

Steam required for the processes should be taken from a well drained steam supply line, or when not available from a steam generator.

The vacuum pump of water ring type takes its sealing water from a vented tank to which it also delivers the used water. The gas leaving the pump escapes through a exhaust pipe, connected to the water tank.

With double ended sterilizers the doors are interlocked, enabling for one door only to be opened at a time. After an error has occurred or whenever manual interference has taken place in the process, the unloading door remains closed and the loading door will be the only one giving access to the chamber.

The steri lizer should be supplied with electri city, cold water, compressed air (or nitrogen when explosion proof) and steam. When the latter is taken from a central production plant, it is essential that the distribution piping is properly drained. If central steam is not available or there are reasons not to use it, an electric steam generator may be supplied.

CAM007 . . . . . Introduction GE 2044

GE 2044

Sterilizer type GE 2044 is the collect ive denominatio n for a range of GETINGE high pressure sterilizers with vertically sliding manual doors, all with the door opening 430 x 430 millimetre

Both single and double ended types exist.

The sterilizers are intended for sterilizat ion of materials in the health servic e as well as in the ind ustry. Adap tation to resp ective ly task is made mainly by selecting type of control unit. This is built up around a micro processor and therefore provides an almost endless number of processes, all characterized by a very good accuracy in controlling the process parameters. Both instantaneous and set values for a proceeding process may be displayed on request.

The al l dominating s terilizing ag ent is stea m with a temperat ure of 120 - 135 °C. Material which may be damaged at this temperature can, in some sterilizer models, be sterilized in formaldehyde vapour at 60 80 °C.

The 2044-sterilizers are intended for processing a great variety o goods such as: instruments, utensils, glass, plastic, leather, textiles, hot or cold liquids in open or ven ted containers and small ri gid pressure tight liquid ampoules. This is done with dedicated programmes.

European Standard EN 285 prescribes the use of fixed programs only. The control equipment of the 2044 sterilizers allows the programs to be varied during testing.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded U-profiles which serve

both as stiffening bars for the pressure vessel, and as a steam jacket containing temperature controlled steam heating the chamber walls.

A vacuumpump of the water ring type removes air, steam and condensate from the chamber. Its seal ing water i s t aken from an open tank which also serves the feed water pump on sterilizers equipped with a built in steam generator.

The condenser between chamber and v acuum pump converts all wa ste steam to water. This reduction of the pump handling volume speeds up the vacuum producing process and will save the pump and waste piping from high temperatures.

A well silenced drain system after the vacuum pump and the well sized thermal chamber insulation makes the sterilizer an environmentally pleasing unit, easy to locate.

The type 2044 sterilizers should be supplied with electricity, cold water, steam and, for LAB- and for maldehyde sterilizers, also compressed air. When steam is taken from a central production plant, it is essential that the distribution piping is properly drained.

If central steam is not available or there are reasons not to use it, an electric steam generator, contained within the cabinet volume may be supplied.

CAM011 . . . . . Introduction to GEF-449 perFORMer

GEF-449 perFORMer

GEF-449 perFORMer is the designation of a series of GETINGE highpressu re steriliz ers with a v ertical manual sliding door, all of w hich

have a charging opening of 430 x 430 mm and a chamber depth of 940 mm.

There are both stand-alone and built-in versions.

The sterilizers a re intended for the sterilization of items in hospitals. They are adapted to the items concerned through the choice of control equipment. This control equipment is based on a microprocessor and consequently offers a number of types of process, all of which are characterized by exceptional accuracy in the regulation of process parameters. The operator can call up information on the current process, current process phase and the actual values of parameters on a display while the process is in progress.

There are two variants of sterilizers, one for a combination of steam

and formalin sterilization and the other for formalin alone.

The sterilizing medium of the combined sterilizer is principally steam at a temperature of 121 - 134°C. Materials which are damaged by this temperature are sterilized in formalin vapour at 50 - 80°C.

Most types of items can be treated in the GEF-449 sterilizers, using adapted programs: Instruments, machine parts, glass, plastics, rubber, leather, textiles and temperature-sensitive materials.

European Standard EN 285 for steam sterilizers spe cifies the use of fixed programs only in steam sterilization. However, the control equipment of the GEF-449 sterilizers allows the programs to be made variable during the time testing is in progress.

As with Getinge's other double-jacketed sterilizers, the external surface of the chamber and doors is half-covered with all-welded U sections. These stiffen the flat walls of the pressure vessel, as well as holding the steam that keeps the chamber walls and doors wa rm to minimize condensation in the chamber. (The doors are only heated in the

case of formalin sterilization.) The principle of design means that all the welds are a ccessible for visu al inspection afte r the thermal insulation has been removed.

A vacuum pump of the water-ring type removes air, steam and condensation from the chamber and door-seal groove. The pump's sealing water is taken from an open tank which also supplies the feed-water pump on sterilizers equipped with steam generators with water.

The con denser between the c hamber and vacu um pump converts waste steam to water. The decrease in volume contributes greatly to making pump operation more efficient and protecting the pump and discharge lines against high temperatures.

A well-damped discharge system after the vacuum pump and welldimensioned thermal insulation around the chamber mean that the sterilizer affects the surroundings of the place where it is installed to an insignificant extent and is therefore a unit that is easy to locate.

GEF-449 sterilizers have to be supplied with electricity, cold water, steam and compressed air. When steam is supplied from a central steam production facility, its distribution system is required to be well dewatered.

If there is no steam network or there are reasons for not using the steam network, an electric steam generator may be installed inside the lining plates on all models.

CAV008. . . . . . Introduction GE 2066

GE 2066

Sterilizer type GE 2066 is the collective denomination for a range of GETINGE high pr essure ster ilizers with vertic ally sliding au tomatic doors, all with the door opening 660 x 660 mm

Both single and double ended types exist.

The al l dominating s terilizing ag ent is stea m with a temperat ure of 120 - 134 °C. Material which may be damaged at this temperature can, in some sterilizer models, be sterilized in formaldehyde vapour at 65 80 °C.

The 2066-sterilizers are intended for processing a great variety o goods such as: instruments, utensils, glass, plastic, leather, textiles, hot or cold liquids in open or ven ted containers and small ri gid pressure tight liquid ampoules. This is done with dedicated programmes.

European Standard EN 285 prescribes the use of fixed programs only. The control equipment of the 2066 sterilizers allows the programs to be varied during testing.

As not only the processes, but also door operation, are c ontrolled automatically, it is not far to full automation of the handling of sterile mate-

rials and goods. The control unit is therefore prepared for controlling a sterilizer having a Getinge ASF automatic loading and unloading unit.

As with Getinge's other double-walled sterilizers, half of the external surface of the chamber is covered by fully-welded U-sections, serving the dual purpose of strengthening the flat walls of the pressure vessel and providing a passage for the steam that keeps the walls of the pressure v essel hot in order to minimise i nternal co ndensatio n. After remo val of the therma l insulatio n, a ll we lds are ava ilable for vis ual inspection.

A well silenced drain system after the vacuum pump and the well sized thermal chamber insulation makes the sterilizer an environmentally pleasing unit, easy to locate.

Type 2066 sterilizers require supplies of electricity, cold water, compressed air and steam. If the steam is supplied from a central steam production plant, it is necessary to ensure that the distrib ution syste incorporates the appropriate pressure reduction valves etc., protected by a safety valve, and that the steam quality is suitable for sterilization purposes.

If central steam is not available or there are reasons not to use it, an electric steam generator, contained within the cabinet volume may be supplied.

CAX044. . . . . . GE-Lab, general (before CAM010)

GE-lab is also provided with a fan inside the chamber. In the sterilising of liquids, when jacket cooling is used to cool the load, the fan is used to increase the cooling power from the cooled chamber jacket.

CAX045. . . . . . GEE-Fan general

The sterilizer is equipped with an internal fan. This ensures that tha gas in the chamber is properly mixed and that the entire load is exposed independent of location.

CAM010 . . . . . Introduction GEF 449

GEF 449

Sterilizer type GEF 449 is the collective denomination for a range of GETINGE sterilizers with vertically sliding manual doors, all with the door opening 430 x 430 millimetre

Both single and double ended types exist.

Material which may be damaged by a temperature of 120 - 135°C can, in some sterilizer models, be sterilized in formaldehyde vapour at 60 80 °C.

The sterilizer chamber, made of acid proof stainless steel is covered externally to about half its area by seal-welded U-profiles which serve both as stiffening bars for the pressure vessel, and as a steam jacket containing temperature controlled steam heating the chamber walls.

A well silenced drain system after the vacuum pump and the well sized thermal chamber insulation makes the sterilizer an environmentally pleasing unit, easy to locate.

The type GEF 449 sterilizers should be supplied with electricity, cold water, steam and compressed air. When steam is taken from a central production plant, it is essential that the distribution piping is properly drained.

If central steam is not available or there are reasons not to use it, an electric steam generator, contained within the cabinet volume may be supplied.

CAX003. . . . . . Safety devices. General

Safety devices, a survey

The panels of the sterilizer shall prevent the operator access to the inne r parts of the sterilize r. Only specially trained personnel have ac ce ss to the inne r parts.

Safety components

Every sterilizer is equipped with a number of components the purpose of which is to specifically guarantee the human safety. These items are marked with the sign below in:

electric diagrams

•

piping diagrams

•

spare parts lists

•

These components have been subject to special tests before accepted as safety components and must therefore not be substituted by any make or execution not approved by GETINGE AB. It is of greatest importance that these components are kept in good working condition in order to maintain a safe function during the sterilizer life time.

The sign is used not only to point out important components, but also to emphasize such other safety factors requiring special attention as measurements, tolerances, material etc.

CAX034. . . . . . GE2044 general

Process stop

Below the front frame above the door there is an emergency stop button. In an emergency, pressing this button makes the steril izer safe.

If the emergency stop button i s operated during a proces s, an alar sounds.

Trim plates

Panels are possible to dismount by means of tools or keys. The panels form a barrier for operators, but not for specially trained technicians.

Valves

Pressure vessel

Stainless steel surfaces within reach of the operating personnel are

insulated so that they are safe to touch.

Both electric and pneumatically actuated valves are made to close by means of spring force. This prevents undesired flow through the valves in case of power failure. A fail safe function is achieved.

The sterilizer chamber, jacket and steam generator are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

The ja cket of a steril izer suppl ied from m ain s team is pro tected against excess pressure by the relief valve compulsory in every main steam supply line. Responsibility for this valve is outside the scope of the sterilizer manufacturer.

The jacket of a steam generator equipped sterilizer is protected against excess pressure by the steam generator relief valve.

The chamber is protected by a relief valve in those cases only when the supply pressure exceeds the chamber design pressure.

Safety valves

The periodical compulsory checking of the steam generator and chamber safety valve functional condition is easily and safely performed by operating a key switch which disconnects the pressure controllers causing the pressure rise to the safety valve opening pressure. See also chapter

Maintenance

CAM008 . . . . . Sterilizer with program combination B2001 or B2002.

in the SERVICE MANUAL.

Doors

The doors are kept closed by the automatic control unit while cycles are in progress and also when supply media fail. The door seals are not pulled back into the seal groove until the condition “

sure = atmospheric pressure”

electric failure causing an opening command.

is fulfilled, not even in case of an

chamber pres-

Water level check

Both sight glass and a pilot light on the sterilizer control panel informs about the water content in the steam generator on sterilizers with a built in steam generator. Steam and water flow may, in case the sight glass brakes, be shut of by two valves that can be operated from the front.

Monitoring the load temperature when sterilizing liquids

Via temperature sensors in the load, the doors are kept closed until the temperature of the liquid has fallen below its boiling point.

CAM009 . . . . . Sterilizer with program combination other than B2001 or B2002.

Doors

The doors are kept closed by the automatic control unit while cycles are in progress and also when supply media fail. The doors cannot be opened until the condition “chamber pressure = atmospheric pressure” is fulfilled, not even in case of an electri c failure causing an opening command.

Water level check

Both sight glass (if fitted) and a pilot light on the sterilizer control panel informs about the water content in the steam generator on sterilizers with a built in steam generator.

Steam and water flow may, in case the sight glass brakes, be shut of

by two valves located behind the lower front panel.

Monitoring the pressure behind the door seal

All valves admitting any medium to the chamber are kept closed until the pressure behind the door seal is high enough to guarantee the tightness of the chamber.

If the pressure falls too low, an alarm sounds.

Monitoring the load temperature when sterilizing liquids

Via temperature sensors in the load, the doors are kept closed until the temperature of the liquid has fallen below its boiling point. In addition to the control system, the temperature of the load is also controlled by a completely independent system.

CAM012 . . . . . GEF-449 perFORMer safety instructions cont.

Doors

The doors are kept locked while the process is in progress and in the event of any losses of media by a balanced spring system and a mechanical door holder. The doors cannot be opened until the condition "chamber pressure <= atmospheric pressure" is met, even if an electrical fault results in an opening command.

Checking of water level

Both a water-level stand, where provided, and an LED on the control panel provide information on the water level in the steam generator in sterilizers equipped with steam generators.

If the sight glass in the water-level stand breaks, the outflow of water and steam can be shut off using two valves located behind the front subpanel.

Monitoring of door-seal sealing pressure

All the valves which supply the chamber with some form of medium are kept closed until the pressure behind the door seal is sufficiently high to ensure that the chamber is leaktight.

If the pressure is too low, an alarm is additionally triggered.

CAV005 . . . . . Vertically moving sliding door

Doors

The doors are kept closed by the automatic control unit while cycles are in progress and also when supply media fail. The doors do not open until the condition chamber pressure = atmopheric pressure is fulfilled, not even in c ase of an electric fai lure causing an opening command. The vertically sliding door is actuated by a compressed air cylinder with a choked air inlet. A much larger outlet is arranged directly at the cylinder end. Objects stopping the upward motion of the door will exert pressure on a plate running the entire length of the top of the door. The plate acts directly upon the outlet valve which opens thereby interrupting the door motion. This will prevent operator injuries and material damage. A brace stops the door from opening in case the pneumatic cylinder should unintentionally become depressurized. The brace can not be removed in case the compressed air pressure is to low to keep the door in the upper position.

CAH001 . . . . . Horizontally moving sliding door Not GEE

Doors

The sterilizer doors are kept closed by the automatic control unit while cycles are in progress and also when supply media fail. The doors do not open until the con dition chamber pressure = atmoph eric pressure is fulfilled, not even in case of an electric failure causing an opening command. The horizontally sliding door is actuated by a pneumatic motor. The force of the pneumatic motor actuating the door is limited so as not to cause any squeeze damage. As an additional safety measure there is a photoelectric device fit ted on to the front panel to sense any object which could be pushed toward the chamber wall by the door motion.

The photoelectric device stops the door-motion before a squeeze-situation occurs, thereby avoiding personal and material damage.

When closing a door the door push button has to be pressed during the entire door closing period. The door stops automatically if the button is released before the door is properly closed.

CAH011. . . . . . Horizontally moving sliding door Not GEE

Doors

The sterilizer doors are kept closed by the automatic control unit while cycles are in progress and also when supply media fail. The doors do not open until the condition chamber pressure = atmopheric pressure is fulfilled, not even in case of an electric failure causing an opening command. The horizontally sliding door is actuated by a pneumatic motor. The force of the pneumatic motor actuating the door is limited so as not to cause any squeeze damage. As an additional safety measure there is a load sensor fitted on the pneumatic motor, to sense any bigger object obstr ucting the door c losing. The load senso r stops the door- motion before a squeeze-situation occurs, thereby avoiding personal and material damage.

When closing a door the door push button has to be pressed during the entire door closing period. The door stops automatically if the button is released before the door is properly closed.

CAH007 . . . . . GEE horizontally moving sliding door

Doors

The doors are kept closed by the automatic control unit while cycles are in pro gr ess an d a lso w hen s up pl y m ed ia fa il . T he do or s can not be opened until the condition chamber pressure = atmopheric pressure is fulfilled, not even in case of an electric failure causing a command to unlock.

The horizontally sliding door is actuated by a pneumatic motor. The force of the pneumatic motor actuating the door is limited so as not to cause any squeeze damage.

Stainless steel surfaces which the operating personnel may come in contact with are insulated and cooled to a harmless temperature.

CAV010. . . . . . GEE Vertical sliding door Safety

Doors

The doors are kept locked while the process is in progress and in the event of any losses of media by the automatic control equipment. The doors will not open until the "chamber pressure = atmospheric pressure"

condition is met, even if an electrical fault were to result in an opening command.

The sliding doors are operated with a compressed-air cylinder which has a substantially narrowed inlet. An outlet valve with a considerably greater throughflow capacity than the inlet is located in the bottom of the cylinder, which faces up. Objects which prevent the upward movement of the door press down a sheet-metal disc which opens the outlet valve so that movement of the door stops. An outlet valve with a considerably greater throughflow capacity than the inlet is located in the bo ttom of t he cyl inde r, wh ich f aces up. O bje cts whic h pre vent the upward movement of the door press down a sheet-metal disc which opens the outlet valve so that movement of the door stops. The stainless steel panels which personnel may touch are insulated and cooled to a non-dangerous temperature.

The stainless steel panels which personnel may touch are insulated and cooled to a non-dangerous temperature.

CAH009 . . . . . GEE, low-pressure, horizontal door

Special attention has been paid to make a tight seal between door and chamber. The do or seal system consists of t wo seals p laced in one groove each around the door opening. One of the seals is pushed against the door surface by means of pressurized ni trogen or compressed air. The other seal is fixed, and tightens against the door when the vacuum in the chamber sucks the door against the chamber.

CAV009 . . . . . GEE Vertical sliding door General

Special steps have been taken to make the seal between the door and chamber secure. The door seal consists of a packing and a mechanical locking system.

CAH008 . . . . . GEE high pressure, horizontal door

Special attention has been paid to make a tight seal between door and chamber. The door seal system consists of two seals placed in o ne groove each around the door opening. The seals are pushed against the door surface by means of compressed ai r (or pressurized nitrogen when explosion proof).

CAH010 . . . . . GEE general

The effectiveness of the seal is supervised by the space between the two seals being evacuated by an ejector and the vacuum created measured by a pressure sensing device. If the ejector should not be capable of maintaining the stipulated vacuum, the pressure sensor will trigger an alarm resulting in the sterilizer being evacuated.

Water level supervision

Both expa nsion vessel and water pump reci rculation tank ar e equipped with sight glass making it possible to check the appropriate water levels.

CAV011 . . . . . . GEE Vertical sliding door Seal

The effectiveness of the seal is checked to starting each process with a leakage test.

Checking of water level

Both the expansion vessel and the tank of the vacuum pump for circulating sealing water are provided with a level sensor which actuates an alarm if the water level is too low.

CAX004. . . . . . General

Emergency stop

In the front panel, at the side of the door, there is a push button mounted having dual functions:

A While actuating the door:

to stop the door motion immediately. A push on the button releases an alarm resulting in the door not moving

B While the door is closed:

During a proceeding process. The process is aborted and all valves for media to the chamber closes. This releases an alarm.

CAX037. . . . . . General, with cleaning key

Door interlock key

The front panel contains a key switch, intended for use when cleaning the sterilizer or when it is necessary to reach into the chamber for any reason. With the key removed, the door cannot be closed. See also unde "Cleaning the chamber" in the OPERATIONS chapter.

CAH002 . . . . . Sterilizer with chamber that can be entered

Door blockage key

In the front panel, next to the door, a pneumatic key switch is mounted. Whoever entering the autoclave chamber shall bring the key. When removed from the key switch, the door is pneumatically blocked from possibilities to close.

CAH014 . . . . . Autoclaves with chamber which permits entry

Door-block ing key

There is a pneumatic key switch on the front panel alongside the door. Anyone entering the autoclave chamber should take the key with them. When the key is removed from the key switch, closing of the door is blocked pneumatically. See also the sub-section headed "Cleaning of chamber" in the section entitled "OPERATION".

CAV007 . . . . . Sterilizer with chamber that can be entered

Door interlock key

In the front panel, next to the door, a key switch is mounted. Whoever entering the autoclave chamber shall bring the key. When removed from the key switch, the door is blocked from possibilities to close.

CAX005 . . . . . General

Trim plates

Panels are possible to dismount by means of tools or keys. The panels form a barrier for operators, but not for specially trained technicians. Stainless steel surfaces within reach of the operating personnel are insulated and cooled to a harmless temperature.

Valves

Normally electric and pneumatically actuated valves are made to close by means of spring force. This prevents undesired flow through the valves in case of power failure. A fail safe function is achieved.

CAH015 . . . . . Sideways-opening doors, general

Lining plates

Front panels and lining panels may only be opened by specially trained technicians, not by operators. Plate surfaces with which the operator may c ome into c ontact are in sulated and cool ed to a tem perature a which it is safe to touch.

Valves

Both electrically and pneumatically controlled valves are closed by spring force. This means that non-permitted flow of steam, water or

gases is prevented if the control medium is lost. The principle is that the valves move to a safe position in the event of a loss of medium.

CAX006. . . . . . GEC A-version

Pressure vessel

The sterilizer chamber and jacket are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

Main steam supply is to be protected against excess pressure by the safety valve, compulsory in every main steam supply line. Responsibility for this valve is outside the scope of the sterilizer manufacturer.

Due to high compressed air pressure, the autoclave chamber is protected by a separate safety valve mounted on the chamber.

CAX038. . . . . . GE, general, A-version

Pressure vessel

The sterilizer chamber and jacket are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

CAH012 . . . . . Pressure vessel GED

Pressure vessel

The chamber and jacket are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

The autoclave chamber is protected by a separate s afety valve mounted on the chamber.

CAX007. . . . . . GEC E-version with vacuum process

Pressure vessel

The sterilizer chamber, jacket and steam generator are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

The steam supply is protected against excess pressu re by the safety valve, mounted on th e steam generator. The jacket of the steriliz er is protected against excess pressure by the steam generator safety valve.

The autoclave chamber is protected by a separate safety valve mounted on the chamber.

CAH016 . . . . . GE E version with 3.5 bar safety valve

Pressure vessel

The autoclave chamber, jacket and steam generator are pressure vessels designed and built in accordance with applicable standards.

Each pressure vessel has a separate safety valve to provide protection against excessively high pressure.

CAX008 . . . . . GEC E-version without vacuum process

Pressure vessel

The sterilizer chamber, jacket and steam generator are pressure vessels, built in accordance with regulations stipulated by supervising authorities.

The steam supply is protected against excess pressu re by the safety valve, mounted on the steam generator.

Due to high compressed air pressure, the autoclave chamber is protected by a separate safety valve mounted on the chamber.

CAX039 . . . . . General for safety valves

Safety valves

Safety valves limit the system pressure, providing the last line of protection to prevent the design pressure of the vessel from being exceeded. Safety valves are required to be inspected at prescribed intervals.

CAX009 . . . . . General E-version

Safety valve, steam generator

The periodical compulsory checking of a built in steam generator safety valve functional condition is easily and safely performed. It is done by operating a key switch which disconnects the pressure controllers causing the pressure rise to the safety valve opening pressure.

Water l evel check, steam generator

Both sight glass and a pilot light on the sterilizer control panel informs about the water content in the steam generator. Steam and water flow may, in case the sight glass brakes, be shut of by two valves.

CAX010. . . . . . General

Monitoring the pressure behind the door seal

All valves admitting any medium to the chamber are kept closed until the pressure behind the door seal is high enough to guarantee the tightness of the chamber.

Monitoring the load temperature when sterilizing liquids

Via temperature sensors in the load, the doors are kept closed until the temperature of the liquid has fallen below its boiling point.

CAH013 . . . . . General GED

Monitoring the pressure behind the door seal

All valves admitting any medium to the chamber are kept closed until the pressure behind the door seal is high enough to guarantee the tightness of the chamber.

CAX040. . . . . . General, liquid sterilization (CAX010)

Monitoring the load temperature when sterilizing liquids

Via temperature sensors in the load, the doors are kept closed until the temperature of the liquid has fallen below its boiling point.

CAX041. . . . . . Formaldehyde

Emergency program when sterilizing using formaldehyde

In the event of abnormal operating conditions, when the temperature or pressure conditions in the sterilizer chamber could damage the load or cause danger, an emergency program operates to terminate the process quickly.

Ventilati on monitori ng

An inte rnational standard reco mmends that the ventilatio n system of formalin sterilizers should be monitored using a flow switch.

The sterilizer is prepared for the fitting of such a flow switch, which then forms part of the safety interlocks.

CAX049 . . . . . perFORMer, emergency program, bottle guard, ventilation monitoring

Emergency program in formalin sterilization

In abnormal operating situations when there is a risk of the temperature and pressure conditions in the sterilizer chamber damaging the load or creating a danger, an emergency program comes into operation which rapidly completes the process.

Bottle guard in formalin sterilization

A bottle guard prevents the formalin program from being started or carried out if a bottle has not been positioned in the bottle holder.

Ventilation monitoring

The international standard recommends that the ventilation syste around formalin sterilizers should be monitored by a flow monitor. The sterilizer is prepared for the connection of a flow monitor, which after being connected becomes part of the safety interlocking system.

CAA005 . . . . . Integral steam generator

Pressure limitation

The operating pressure of the steam generator is restricted by a pressure switch that interrupts the electricity supply to the steam generator at a pressure of about 0.5 bar (g) below the opening pre ssure of the safety valve.

Boil-dry protecti on

In the event of failure of the water supply, the boil-dry protection interrupts the electrical supply when the water level falls to a certain level.

Overheating pro tection

This protection prevents the steam generator from o verhea ting if the boil-dry protection should fail to operate.

Reset push-b utton

After operation of any of the steam generator safety devices, the fault must be rectified and the alarm reset manually in accordance with current regulations for steam pressure vessels.

Water l evel monitoring

An LED in the sterilizer instrument panel indicates satisfactory water level in the steam generator. On certain models, the water level can also be seen in the steam generator sight glass.

Safety switch

It must be possible to interrupt all electrical supp lies to the ste am generator by means of a safety switch. See also the INSTALLATION chapter.

CAA006. . . . . . Built-in steam generator

Pressure limitati o n

The operating pressure of the steam generator is checked by a pressure switch which cuts the power supply when the pressure rises to approx.

0.5 bar (e) below the opening pressure of the safety valve.

Boil-dry protection

If the water is not topped up, the boil-dry protection cuts the power supply when the water level falls below a particular limit.

Overheating protection

This protection prevents overheating if the boil-dry protection fails to work.

Resetting button

If a fault is triggered by any of the safety components of the steam generator, the fault must be manu ally reset in accordance with applicable regulations on steam boilers.

Water-level monitoring

An LED on the instrument panel of the connected autoclave indicates a satisfactory wa ter level in the st eam generator. The level can also be read off on the water-level stand of the steam generator on some mod-

els. This stand is provided with two valves which can be closed to prevent water and steam from escaping if the sight glass bursts.

Safety switch

It must be possible for all power supply to the steam generator to be cut with a safety switch. See also the section on INSTALLATION.

CAA004 . . . . . Steam converter. Water level monitoring

Water level monitoring

An LED in the sterilizer instrument panel i ndicates satisfactory water level in the steam generator. On certain models, the water level can also be seen in the steam generator sight glass.

THE PROCESS

DAX013 . . . . . GEV general

The GEV-process

The process starts by the door seal being pressed towards the door by means of compressed air.

DAX014 . . . . . GEV direct heating

Heating the load

The fan starts as soon as all start conditions are fulfil led. The load is heated by means of steam which is admitted into the chamber so as to cause a direct contact with the load. The amount of steam is controlled by the control unit, to give the required gradual increasing of the chamber and load temperatures.

The fan recirculates the air-steam mixture over the load during the whole process. This continuous circulation of the atmosphere gives a very uniform chamber temperature during all stages of the process Forming of layers of air and steam is eliminated due to the turbulence in the chamber.

DAX015 . . . . . GEV indirect heating

Heating the load

The f an starts immedi ately wh en all start conditions a re fulfil led. In some processes the load is preheated by means of hot air. This air is heated by entering steam into the heat exchangers in the chamber. This preheating will reduce the condensation of steam on the load.

After the preheating, steam is admitted into the chamber so as to cause a direct contact between steam and load. The amount of steam is controlled by the control unit, to give the required gradual increasing of the chamber and load temperatures. The fan recirculates the air-steam mixture over the load during the whole process. This continuous circulation of the atmosphere gives a very uniform chamber temperature during all stages of the process. Forming of layers of air and steam is eliminated thanks to the turbulence in the chamber.

DAX028 . . . . . GEV Indirect heating, jacket heating

Heating t he load

The fan s tarts immediate ly when all start conditions are ful filled. In some processes the load is preheated by means of hot air. This air is heated by entering steam into the jacket of the chamber. This preheating will reduce the condensation of steam on the load.

DAX016 . . . . . GEV general

Sterilization p e riod

Autoclave chamber and load is heated to sterilization temperature and kept at this temperature for the stipulated time or until the required F0value is reached.

Cooling

The cooling starts after completed sterilization period. A gradual lowering of the load temperature is achieved by cooling down the circulating air when passing the heat exchanger. The speed of the cooling can be controlled within wide limits.

Process end

When the temperature in the load has reached the predetermined final temperature the fan(s) stops. The pressure is let down to atmospheric. The door seal will then be withdrawn into its groove by vacuum. The sterilizer will remain in this state until the unloading door is opened.

Chamber pressure during the process.

During the heating, sterilization and cooling phases of the cycle, an air support pressure following a programmed pattern can be applied to the chamber to balance pressure differences between the chamber and the inside of the packages. This is to prevent distortion or damag e to the containers or their closures.

DAX007 . . . . . GEC general

The GEC-process

The process starts by the door seal being pressed towards the door by means of compressed air.

Water filling

Next phase is filling the sterilizer chamber with process-water up to a contr olled leve l. Only a mi nor portio n of t he cha mber i s fil led with water. Depending upon the product requirement, the quality of the process-water may be of a high standard such as WFI (Water For Injection).

A centrifug al pump recirculates the water whi ch is continuously sprayed over the load during the whole process. The continuous spraying of water gives a very uniform chamber temperature during all stages of the process.

DAX008 . . . . . GEC direct heating

Heating the load

The load is heated by means of steam. The steam is admitted into the chamber so as to cause a direct contact between steam, goods and water. The amount of steam is controlled by the control u nit, to give t he required gradual increasing of the chamber and load temperatures.

DAX009 . . . . . GEC indirect heating

Heating t he load

The system is heated by means of steam. The steam heats the process water in the heat exchanger, thereby eliminating the risk of the water being contaminated with chemicals or f oreign particl es. The warmed process water will heat the load when passing through the autoclave chamber.

The amount of steam is controlled by the control unit, to give the

required gradual increasing of the chamber and load temperatures.

DAX010 . . . . . GEC general

Sterilization p e riod

Proces s water , auto clave ch amber and load is heate d to sterilization temperature and kept at this temperature for the stipulated time or until the required F0-value is reached.

Cooling

The cooling starts when the sterilization period has been completed. A gradual lowering of the load temperature is achieved by cooling down the c irculating p rocess w ater when pas sing the heat exchanger. The speed o f t he cooling can be controll ed wi thi n w id e limi ts . T he hea t exchanger ensure s that p rocess-water and cooling-water are neve mixed.

Process end

When the temperature in the load has reached the predetermined final temperat ure the circulat ion pump stops . T he water in the chamber i drained out and the pressure is let down to atmospheric. The door seal will then be withdrawn into its groove by vacuum. The sterilizer will remain in this state until the unloading door is opened.

Chamber pressure during the proc e ss

During the heating, sterilization and cooling phases of the cycle, an air support pressure following a programmed pattern can be applied to the chamber to balanc e pressure differences betwe en the chamber and the inside of the packages. This is to prevent distortion or damage to th e containers or their closures.

DAX019 . . . . . GEE general

The ethylene oxide process

A vacuum pump of the water ring type removes air, steam and condensate from the chamber. The pum p sealing water is taken f rom and exhausted to one and the same container thereby forming a closed system not permitting gas-contaminated water leaving the sterilizer uncontrolled.

Gas exhausted f rom the sterilizer and evaporating from the recirculating sealing water is also collected in the container and fed to the destruction unit or to the open air through a sealed tube.

An alarm system with visible and audible signals cover most irregular situations which may occur. Simultaneously this system automatically introduces an emergency program, adapted to the process cut point, which brings the process safely to an end.

Pretreatment

AIR REMOVAL

It is important that the sterilant comes in close contact with the microorganisms to be killed. Any air present serve s as an insulation which prevents the desired contact and lowers the temperature.

A pretreatment phase consisting of a number of pressure variations following a certain pattern effectively removes air from various types of goods.

LEAK TEST

The chamber has to be absolutely tight during the comparatively long process time of an ethylene oxide sterilisation. Each process therefore starts with a leak test which has to be satisfactory to let the sterilizing cycle proceed.

HUMIDIFICATION

It has been generally accepted that moisture is an essential element in achieving sterility when autoclaving. The steam admitted between the evacuation periods during the air removal stage will not humidify the goods to the desired extent. The chamber therefore is kept filled with saturated steam at a pressure corresponding to the chamber wall temperature for a period of time selected by the operator. This time may vary with different kinds of load and type of biological indicators.

Sterilizing

Post treatment

The gas ste rilant st ored as a liqui d in a gas bottle is admitted via an evaporator to produce an ethylene oxide concentration of about 650 mg/ litre in the chamber. The sterilizing temperature is kept at predetermined level by controlling the heat admitted to the jacket and the gas. The sterilizing time, adapted to the type of goods to be processed, is set by the operator.

The the objective of the post treatment, consisting of repeated evacuations and admissions of sterile filtered air/nitrogen, is primarily to extract the gas from the goods and to normalize the temperature and moisture content of it.

The goods will, in spite of this treatment, retain some ethylene oxide which may be hazardous to humans. After a gas sterilization, materials should therefore be aerated in a well ventilated area at room temperature for a period of time which may vary between 24 hou rs and seven days depending on type of goods. The time can be shortened if the goods is aerated in a heated, ventilated cabinet specially designed for this purpose.

DAX023 . . . . . Description of the steam sterilization process. Hospital div.

The st ea m process

The phase list, in the SERVICE MANUAL, is the only document which in detail describes the processes. This phase list is mainly intended for the technicians.

The universal steam-autoclaving process can be divided into three main phases:

ABC

A Pretreatment B Sterilizing C Post-treatment

Pretreatment

It has been generally accepted that moisture is an essential element in achieving sterility with steam. Therefore it is important that the steam comes in close contact with the microorganisms to be killed. Any air present serves as an isolator preventing the desired situation besides its ability to lower the temperature.

A pretreatmen t phase consisting of a number of pressure variat ions following a certain pattern effectively removes air from various typ es of goods simultaneously producing the moisture required prior to the subsequent sterilizing phase.

Sterilizing

Air removal when autoclaving aqueous solutions in open containers is made by a single provocateur or flowing steam in order not to make the liquid come to boiling during the decompression periods in a pulsating procedure.

For sterilizers equipped with the computerized control unit, the sterilizing time starts at the instant in the pretreatment phase of the process when the chamber temperature transducer signals a temperature equal to or higher than the sterilizing temperature sp ecified for the current program. If the temperature transducer registers a value outside the temperature band, or if the temperature differs by more than ±1.5K fr om the chosen sterilizing temperature, an alarm sounds.

When sterilizing goods, in particular liquids, where the sterilizing temperature is measured in the goods, the transducer “Control temp 1” is used. The condition for starting the sterilizing timer is that both transducers, “Chamber” and “Control temperature 1”, detect the programmed sterilizing temperature.

Post-treatment

The post-treatment is intended to normalize the temperature and moisture content of the goods. All types of goods except liquids therefore are exposed to a vacuum deeper than 70 mbar(a) for a certain period of time. Textiles may after such a post-treatment still appear to increase in weight by about 1% which consequently represents a normal wate addition during a sterilization process.

The post-treatment of aqueous solutions sterilized in open or vented container s consists of a period of natural cooling while pre ssure and temperature are lowered slowly until the temperature of the liquid is safely below its boiling point. This process is speeded up by applying a slight vacuum to the chamber when its pressure approaches atmospheric.

NOTE that liquids must only be processed in sterili zers which are equipped with program for this type of load.

Pressure equalization from vacuum takes place by admitting atmospheric air into the chamber via a filter that prevents bacteria from entering the chamber. The efficiency of the filter is 99.998% for particles of order of size 0.3 micron (0.0003 mm).

The sterilizer door will remain sealed by its gasket until atmospheric pressure prevails in the chamber.

Process adaptation

A large number of factors such as type of goods, goods carrier, packaging material, etc. affect the result of the process. The control equipment offers a number of features that can be used to optimize the processes to suit the requirements of different customers. For further information, see “Customer-programmable functions” in the SERVICE MANUAL.

DAX011. . . . . . Vacuum cycle

Steam/vacuum-process

As the sterilizer is equipped with a vacuum pump it can serve as an ordinary steam ste rilizer, suita ble for steriliza tion of utensils, contai ners, textiles etc.

The universal steam/vacuum process can be divided into pretreatment

(A), sterilizing (B) and post-treatment (C).

Pretreatment

It has been generally accepted that moisture is an essential element in achieving sterility with steam. Therefore it is important that the steam comes in close contact with the microorganisms to be killed. Any air present serves as an insulation which prevents the contact and lowers the temperature.

A pretreatment phase, consisting of a number of pressure variations following a certain pattern, effectively removes air from various types of goods and produces the moisture required in the subsequent sterilizing phase.

Air removal when autoclaving aqueous solutions in open containers is made by a single prevacuum or flowing steam in order to avoid that the liquid comes to boiling during the decompression periods in a pulsating procedure.

Sterilizing

Posttreatment

Counting the sterilizing time starts from the moment when the chamber temperature transducer signals a temperature equal to or higher than the chamber temperature set point. Count down of the sterilizing time stops at temperatures below this threshold temperature.

When sterilizing goods, in particular liquids, where the sterilizing temperature is measured in the goods, load sensors are used. The condition for starting the sterilizing timer is that chamber sensor and all load sensor s indicat e a temperat ure equal to or above no mina l s teri lizing temperature

The posttreatment is intended to normalize the temperature and moisture content of the goods. All types of goods except liquids therefore are exposed to a deep vacuum for a certain period of time.

The posttreatment of aqueous solutions sterilized in open or vented container s consists of a period of natural cooling while pre ssure and temperature are lowered slowly until the temperature of the liquid is safely below its boiling point. This process is speeded up by applying a slight vacuum to the chamber when its pressure approaches atmospheric.

The sterilizer door will remain sealed by its gasket until atmospheric pressure prevails in the chamber.

DAH001 . . . . . GED Vacuum cycle

Steam/vacuum-process

The universal steam/vacuum process can be divided into pretreatment (A), disinfection (B) and post-treatment (C).

Pretreatment

It has been generally accepted that moisture is an essential element in achieving sterility with steam. Therefore it is important that the steam comes in close contact with the microorganisms to be killed. Any air present serve s as an insulation which prevents the contact and lowers the temperature.

DAH002 . . . . . GED Outlet filter

Air expelle d from t he cham ber dur ing the pretrea tment sta ge of the process is filtered through a sterile filter before it is allowed out in the service area.

DAH003 . . . . . GED steam/vacuum process (cont.)

Disinfection

Counting the disinfection time starts from the moment when the chamber temperature transducer signals a temperature equal to or higher than the chamber temperature set point. Count down of the disinfection time stops at temperatures below this threshold temperature.

Posttreatment

The posttreatment is intended to normalize the temperature and moisture content of the goods. All types of goods therefore are exposed to a deep vacuum for a certain period of time.

The autoclave door will remain sealed by its gasket until atmospheric pressure prevails in the chamber.

DAX030 . . . . . Formaldehyde process GED

The for mal dehyde proc es s

The Getinge formaldehyde autoclave is intended for sterilization of heat sensit ive goods which can not be processed in a conventional stea sterilizer. The formaldehyde process is developed to be effective on plain surfaces as well as in cavities and deep lumina at a temperature not exceeding 60 oC, 65oC or 80 oC alternatively.

The active sterilizing agent is formaldehyde, a non visible gas with an unmistakable pungent odour. It is easily solved in water to about 40% at room temperature. When solved in water it is sometimes called formalin. Gas and water can be separated by heating the solution. Some people are predisposed to allergies caused by formaldehyde even a very low concentrations and therefore great care is necessary when handling this material.

The process is graphically described below.

ABC

A = Pretreatment B = Sterilization C = Posttreatment

Before the formaldehyde is admitted, the goods a re sub ject to a pretreatment consisting of repeated evacuations and steam flushes. This procedure aims at removing air from the goods, heating them and humidifying the microorganisms to make them susceptible to formaldehyde.

At the beginning of the sterili zing phase the formaldehyde is introduced to the process by admitting formaldehyde solution from a punctured injection flask. The formaldehyde is transferred to a steam heated cavity where it is evaporated before it continues into the chamber in the state of a gas. Steam then is added to keep the temperature at predetermined constant level. Penetration to all parts of the chamber and load is facilitated by the continuous vacuum prevailing in the chamber during the whole process. Circulating hot water, or steam at vacuum conditions in the chamber jacket keeps the chamber walls warm, thereby preventing condensate forming on these.

Upon the predetermined sterilizing holding time expiring, the posttreatment takes place. This aims at effectively removing the formaldehyde from the goods and is achieved by a number of repeated vacuums and intermediate steam flushes.

The process ends up with a deep vacuum followed by a number of pulsating air flushes via the air-in filte r. Thi s part of the pr ocess is to remove remaining small amount of formaldehyde residuals in the goods and the chamber and to restore the humidity and temperature of the goods.

DAX034 . . . . . Formaldehyde process, hospital

The formaldehyde process

The Getinge formaldehyde autoclave is intended for sterilization of heat sensiti ve goods whi ch can not be processed in a conventional s team sterilizer. The sequences of the process are such that it is effective for use with both porous and solid materials, as well as on open surfaces, hollows and narrow lumens. The sterilization temperature is 80°C, but the process can be operated with 65°C1 as the maximum temperature.

1. 60°C on certain models

The process is graphically described below.

ABC

A = Pretreatment B = Sterilization C = Posttreatment

Before the formaldehyde is admitted, the goods are subject to a pretreatment consisting of repeated evacuations and steam flushes. This procedure aims at removing air from the goods, heating them and humidifying the microorganisms to make them susceptible to formaldehyde.

In connection with the steam flushes, formaldehyde is admitted to the chamber as follows. An injection flask, containing a solution of formaldehyde in water (formalin), is punctured by a needle, allowing the formalin to be drawn into a steam-heated evaporator connected to the chamber. The evaporator drives off the formaldehyde from the formalin solution, from which it is drawn into the chamber by the vacuum there, and which is maintained in the chamber throughout the entire process. Steam is admitted after the formaldehyde adm ission, to maintain the chamber temperature at the correct value. The walls of the chamber are heated ex ternally by steam, preventing conden sation from forming internally.

On conclusion of the prescribed dwell time, the chamber is evacuated and temperature-controlled steam again admitted. This evacuation, followed by steam admission, is repeated many times. This part of the process, referred to as washing, effectively removes any traces of formalin f rom the goods, which i s of vi tal import ance when bearin g in mind the risks of formaldehyde allergy.

The process ends up with a deep vacuum followed by a number of pulsating air flushes via the air-in filter. This part of the process is to remove remaining small amount of formaldehyde residuals in the goods and the chamber and to restore the humidity and temperature of the goods.

DAX038 . . . . . Killing process

Killing process.

The sterilizer is provided with one or more processes for killing in which the gases leaving the sterilizer chamber are also sterilized.

The steam enters at the bottom of the chamber so that the condensate and any product residues that have accumula ted there are heated and sterilized. Steam, air and gases leave the chamber via connections on the side of the sterilizer. This steam/gas mixture passes through a sterile-filtering filter before it reaches the sterilizer’s condenser.

During the sterile phase the filter is kept at sterilization temperature and the material that becomes caught in it is therefore sterilized.

In the post-treatment, after the sterile phase, the ordinary outlet in the bottom of the chamber is used to drain the condensate that has accumulated there.

In those cases where a killing process does not perform ordinary pretreatment and sterile phases correctly, post-treatment (evacuation/pressure equalization) takes place through the filter. The doors cannot then be opened until a correct killing process has been performed.

DAX012 . . . . . GEC / GEV with vacuumpump and program for leak test

Chamber leak test

The autoclave is equipped with a program for automatic leak test of the autoclave chamber. A leak test shall be performed with empty chamber.

The leak t est proces s has it s own pr ogram numb er (See list of programs).

The vacuum pump evacuates the chamber. The pump stops when a deep vacuum is reached. For a short period of time after this evacuation a slight rise of the chamber pressure takes place which is not due to leakage but results from evaporation of condensate and temperature - pressure changes of the recently rarefied residual steam.

A satisfactory le ak test allows for a maximum permissi ble pressure

raise of 13 mbar / 10 minutes. A failed leak test will result in an alarm.

DAX017 . . . . . Hot leak test

Chamber leak test

The autoclave is equipped with a program for automatic leak test of the autoclave chamber. A leak test shall be performed with a preheated sterilizer and with empty chamber. The leak test process has its own program number (See list of programs).

Test period

The vacuum pump starts and evacuates the air from the chamber. This is done in three evacuations and entering steam between each evacuation. After the last of the three evacuations the chamber is heated to working temperature and kept at this temperature for stabilization. Then the vacuumpump is started once more. The pump stops when a deep vacuum is reached in the chamber.

For a short period of time af ter this e vacuation a slight rise of the chamber pressure takes place which is not due to leakage but results from evaporation of condensate and temperature - pressure changes of the recently rarefied residual steam.

A ch amber press ure rise caused by air leaka ge can not be detected until the conditions in the chamber are stable. Not earlier than 5 minutes after the vacuum pump has stopped should the pressure and time be measured. A satisfactory leak test allows for a maximum permissible pressure raise of 13 mbar / 10 minutes. A failed leak test will result in an alarm.

Test period

PGMP006.EPS

DAX024 . . . . . Semi automatic leak rate test

Leak te st

All program combinations include a program for checking the tightness of the sterilizer. This test, known as a leak rate test or simply leak test, is used to reveal leaks in the system that might lead to air entering the chamber and putting sterility at risk.

The test is done with the sterili zer empty and with a vacuum in the chamber. A check pressure gauge that should meet the requirements of EN285 and a stopwatch are needed. The pressure gauge is connected to the VT connection of the chamber and must be fitted with a valve so that the connection to the chamber can be shut of while there is a positive pressure inside it.

Semiautomatic leak test with warm sterilizer

The checking process has its own program button (see list of available programs) which starts a process and stops it when the programmed dry vacuum time has elapsed. After the vacuum pump stops, the pressure in the chamber rises for a time. This is not due to leakage but to condensate in the chamber boiling and to diluted residual steam expanding again when the temperature in the chamber equalizes.

Perform the following actions when the vacuum pump stops:

• Open the shut-off valve to the check pressure gauge.

• Wait about ten minutes until the lamp in the start button starts to

flash.

• Note the pressure reading of the check pressure gauge and start the

stopwatch.

• Wait ten minutes and note the check gauge reading again.

• The sterilizer passes the test if the pressure rise does not exceed

13 mbar.

• Press the start button to terminate the test.

On double-ended sterilizers, when the leakage test is complete

loading door

was programmed.

opens automatically or manually depending on how its

the

A Normal post-vacuum 5 min.

B Stabilization of chamber atmosphere 10 min. C Check time 10 min. D Pressure rise.

DAX025 . . . . . Automatic leak rate test. Hospital division

Leak test

Automatic process for steam sterilizers

With sterilizers equipped with a pressure transducer the leak test can easily be automa tically p erformed. The leak test shall be performed with empty chamber.

The checking process has its own program button (See list of programs) which starts one of the standard processes contained by the control unit in question, but aborts this at a moment when the vacuum pump has created a deep vacuum in the chamber. For a short period of time after this evacuation a slight rise of the chamber pressure takes place which is not due to leakage but results from evaporation of condensate and temperature - pressure changes of the recently rarefied residua steam.

A chamber pressure rise caused by air leakage can not be established until the conditions in the chamber are stable. Not earlier than 10 minutes after the vacuum pump has stopped should the pressure and time be measured.

A sat isfactor y leak tes t allows for a maximu m permi ssible pressure raise of 13 mbar / 10 m.

With double ended sterilizers, pleted leak test either automatically or manually, depending on the type of programming made.

A Normal post-vacuum 5 min. B Stabilization of chamber atmosphere 10 min.

the loading door

opens after a com-

C Check time 10 min. D Pressure rise

DAX026 . . . . . Kihlström recorder. Circular diagram.

Documentation of the process

A chart-type pressure and temperature gauge continuously records the pressure and temperature in the chamber on a circular chart. The edge of the chart is marked in hours. The chart rotates once every 12 hours.

A Pressure B Temperature 1 Start:

The process is started by selecting a program and pressing the “Start” button. The pressure curve shows atmospheric pressure.

2 Pretreatment:

The process begins with three vacuum applications down to about 90% vacuum, with steam admitted between each one. The vacuum applications can be seen as small deflections of the curve on the chart.

3 Sterilizing:

When the sterilizing temperature is reached, the curves level out. The start of the sterilization time is indicated by a lamp lighting up on the control panel. The length of the sterilization time is determined by the set parameters.

4 Post-treatment:

At the end of the sterilization time the vacuum pump starts and the pressure falls rapidly. The temperature curve falls quickly at first, then levels out.

5 Drying vacuum applied for the time that is determined by the

set parameters.

6 Pressure equalisation:

At the end of the drying vacuum time, air is admitted to the chamber through a sterile filter. When the chamber reaches atmospheric pressure, the door seal (which was pressed against the door by steam pressure during the process) is drawn in and the door can be opened.

DAX041 . . . . . Line printer. Recording on tape, GED process

100

150

-1

Bar

Documentation of the process

The illustration below is schematic and should not be used as a model for evaluating individual process results.

A printing pressure and temper ature recorder continuously records the pressure a nd tempe rature in th e chamber on graph paper. The graph paper has scales for pressure and temperature.

A Pressure B Temperature 1 Start:

The process is started by pressing the "Start" button after a program has been selected. The pressure curve shows atmospheric pressure.

2 Pre-treatment:

The process begins with vacuum suction(s) down to approx. 90% vacuum with steam intake between each suction.

3 Disinfecting:

When the disinfecting temperature has been reached, the curves level out. The start of the disinfecting phase is indicated on the panel by a lamp lighting up. The length of the disinfecting time is determined according to the parameter settings.

4 Post-treatment:

After the disinfecting time has come to an end, the vacuum pump starts and the pressure decreases rapidly. The temperature curve at first falls rapidly and then levels out.

5 Drying vacuum is drawn during a period of time determined

according to the parameter settings.

6 Pressure equalization:

When the drying-vacuum time has come to an end, air is released into the chamber through a sterile filter. When atmospheric pressure prevails in the chamber, the door gasket (which during the process has been pressed against the door with steam pressure) is drawn in and the door can be opened.

DAX039 . . . . . Paper strip recorder MDD

Documentation of the process

The picture below is schematic and is not to be used as a model for evaluating individual process results.

A chart-type pressure and temperature gauge continuously records the pressure and temperature in the chamber on a chart. The chart has scales for pressure and temperature.

150

100

Bar

-1

A Pressure B Temperature 1 Start:

The process is started by selecting a program and pressing the “Start” button. The pressure curve shows atmospheric pressure.

2 Pretreatment:

The process begins with three vacuum applications down to about 90% vacuum, with steam admitted between each one.

3 Sterilizing:

4 Post-treatment:

At the end of the sterilization time the vacuum pump starts and the pressure falls rapidly. The temperature curve falls quickly at first, then levels out.

5 Drying vacuum applied for the time that is determined by the

set parameters.

6 Pressure equalisation:

DAX042 . . . . . Supervisor Hospital Division, GED process

Documentation of the process

The illustration bel ow is schematic an d should not be used as a model for evaluating individual process results.

PACS SUPERVISOR is a stand-alone meas uring system which records the process data of the autoclave. When the supervisor is connected to a printer directly on the autoclave or via a stand-alone PC with Getinge's OPC or OPH program, a complete printout of recorded data is obtained. There are four different printout alternatives ('modes'), of which the one described is pre-set on delivery and is recommended by Getinge. If pr intou t or pr inte r er rors occ ur, the s upervis or can save th e m os recen tly run process for an 'em ergency printout' which can b e made later. For further information, see the section on the supervisor in the SERVICE MANUAL section on CONTROL UNIT PACS 2000.

: 94/03/08 : 12/10/39 :MODELL :1 :300

134 °C

00.07.00

00.03.00

00.00.00

00.05.00

PROGRAM: P1 PROG. TIME AI00

AI01

AI0

134.0

134.1

134.0

134.1

134.0

134.1

134.0

1.002

0.885

1.105

3.055

2.751

0.070

0.550

1.002

1.004

3 5

DATE PROCESS START AUTOCL AVE NAME AUTOCL AVE NUMBER CYCLE COUNTER

PARAMETERS STERIL IZI NG TEMP. STERILIZING TIME POSTVACU U M TIME POSTPUL S. STEAM POSTPUL S. AIR

SIGNALS AI00 CHAMBER T E MP. AI01 JACKET TE MP . AI0 CHAM BER PRESSURE

PROGRAM: P1

AI00

AI01

AI0

71.2

105.6

134.0

130.2

105.1

50.2

75.0

75.2

134.0

134.1

134.0

134.1

134.0

134.1

134.0

1.002

0.885

1.105

3.055

2.751

0.070

0.550

1.002

1.004

3 5

START

00.00.00 PREVACUU M

00.00.20 HEATING 1

00.08.10 STERILIZ IN G

00.11.00 START POSTT REAT .

00.18.00 POSTVACU UM

00.18.20 POSTPULS . AI R

00.21.20 PRESS. EQ.

00.26.20 PROCESS CO M PLET E

12.49.20 PROCESS FA U LT

PASSWO RD : 1

SIGNATURE:......................

0,0 60,0 90,0 120,0 150,0

0,000

30,0

1,000 2,000 3,000 4,000 5,000

0.10

0.20

0.30

0.40

0.50

1 Date is indicated as day/

month/year. Year/month/day is used for Sweden.

2 Time when the autoclave was

started. Indicated according to the 24-hour clock.

3 Type designation or name

symbol of the autoclave.

4 Autoclave number, which is

a number between 1 and 99 and is used in communication between more than one PACS 2000.

5 Cycle counter for up to

6 The parameters which can be

65,535 processes.

modified with parameter codes are enumerated under the heading of PARAMETERS. In this example the parameters are disinfecting temperature (7) in °C and the times for various sub-processes (8-11) in hours, minutes and seconds.

12 The parameters selected for

printout are enumerated under the heading of SIGNALS.

13 Designation for the program

which has been started. 14 Process logging. 15 Printed out if an error has

occurred during the process. 16 These lines are printed after a

faulty process. As well as a

code which indicates who

has entered the authority

code, there is a line for ini-

tials. 17 Graphic presentation of the

process.

DAX040 . . . . . Supervisor, hospital division MDD

Documentation of the process

PACS SUPERVISOR is an independent measuring system that records the sterilizer's process data. If it is connected to a printer with the sterilizer, or via an independent PC running Getinge's OPC or OPH programs, a complete printout of the recorded data can be obtained. Four different modes of this printout are available, of which the one shown below is the default arrangement from delivery, and is recommended by Getinge. If a fault should occur during printout, or if the printer should fail, the Supervisor can store data for the most recent process, producing an emergency printout afterwards. For more information, see the “Supervisor” section in the PACS 2000 CONTROL UNIT chapter of the SERVICE MANUAL.

The picture below is schematic and is not to be used as a model for evaluating individual process results.

: 94/03/08 : 12/10/39 :MODELL :1 :300

134 °C

00.07.00

00.03.00

00.00.00

00.05.00

PROGRAM: P1 PROG. TIME AI00

AI01

AI0

134.0

134.1

134.0

134.1

134.0

134.1

134.0

1.002

0.885

1.105

3.055

2.751

0.070

0.550

1.002

1.004

3 5

DATE PROCE SS START AUTOCLAVE NAME AUTOCLAVE NUMBER CYCLE COUNTER

PARAMETERS STERILIZING TEMP. STERILIZING TIME POSTVAC U UM TIME POSTPULS. STEA M POSTPULS. AIR

SIGNALS AI00 CHAMBE R TEMP. AI01 JACKET TEMP. AI0 CHAMBER PRESSURE

PROGRAM: P1

AI00

AI01

AI0

71.2

105.6

134.0

130.2

105.1

50.2

75.0

75.2

134.0

134.1

134.0

134.1

134.0

134.1

134.0

1.002

0.885

1.105

3.055

2.751

0.070

0.550

1.002

1.004

3 5

START

00.00.00 PREVACUUM

00.00.20 HEATING 1

00.08.10 STERIL IZI NG

00.11.00 START PO STT REA T.

00.18.00 POSTVACU U M

00.18.20 POSTPUL S. AIR

00.21.20 PRESS. EQ .

00.26.20 PROCESS COMPLE TE

12.49.20 PROCESS FAULT

PASSW OR D : 1

SIGNATURE:......................

0,0 60,0 90,0 120,0 150,0

0,000

30,0

1,000 2,000 3,000 4,000 5,000

0.10

0.20

0.30

0.40

0.50

1 Date in the format day/

month/year. (For Sweden, year/month/day)

2 Time sterilizer was started,

using the 24-hour clock.

3 Sterilizer type designation or

symbolic name

4 Sterilizer number, a number

between 1 and 99 which is used during communication between several PACS 2000 units.

5 Cycle counter for up to

65,535 processes.

6 Listed under the heading

PARAMETERS, the parameters in the current program that can be changed with a parameter code. In this example Sterilizing temperature (7) in °C and times for various (8-11) in hours, minutes and seconds.

12 Listed under the heading

SIGNALS, the parameters

chosen for printing. 13 Name of started program. 14 Process logging 15 Printed out if an error occurs

during the process. 16 These lines are printed out

after a faulty process. Code

identification of the person

who entered the password,

and one line for initialling. 17 Graphic representation of the

process

DAX018 . . . . . Manual filter sterilization

Air filter sterilization

The sterilizer is equipped with systems for manual sterilization of the air filter. Also a system for the wetting of the filter, prior to integrity testing, is provided.

Those systems, together with operating instructions, are described in the SERVICE MANUAL, chapter

DAX021 . . . . . Automatic filter sterilization

Air filter sterilization and test

The sterilizer is equipped with a program for automatic air-filter sterilization and in-line testing.

Note: Before starting the test program, make sure that the container for wetti ng liquid contains enough wetting liquid. Also check that the hoses for the wetting liquid container and the collecting vessel is firmly connected.

Maintenance

The t ype of wett ing liquid to be used, is de scribed i n th e SERVIC E MANUAL.

The filter sterilization and test has its own program number (See list of programs).

The program includes 3 steps:

1. Sterilization: The filter is sterilized by passing steam through the filter and the filter housing. A temperature sensor in the drainpipe controls the temperature.

2. Wetting of filter cartridge: The wetting liquid fills up the filter housing. By using a special wetting liquid the pores in the filter membrane will be filled with liquid. When the filter housing is drained, required liquid will trapped in the filter.

3. Test: After the wetting phase the upstream side of the filter cartridge will be pressure tested by compressed air. It can be determined whether the filter is OK or not by measuring the leakage of air through the filter cartridge. A failed test will result in an alarm.

DAX036 . . . . . Automatic filter sterilization and testing, WIT

Sterilization and testing of the air filter

The sterilizer has a program for sterilizing and testing the air filter.

NOTE: The temperature in the service room and of the water used for the test should be between 20 oC and 30 oC for a reliable test.

Filter sterilizing and testing has its own program number (see THE PROGRAM COMBINATION).

The program has the following stages:

1. Sterilizing: The filter is sterilized by steam flowing through the filter and the filter housing. The temperature is controlled by means of a temperature sensor located in the outlet.

2. Filling filter housing with water: The space in the filter housing, upstream of the filter cartridge, is filled with water and the trapped air is placed under pressure. This pressure is held for a stabilizing period.

3. Test: When it has been filled with water, the filter is pressure-tested by the compressed air influencing the pressure on the water upstream of the filter. By measuring the pressure drop across the filter cartridge and the water flow rate through it, it is possible to determine whether the filter is serviceable or not. If the test is negative, an alarm is given.

4. When the alarm has been acknowledged, the operator can choose to continue the process (press start/restart) or to rerun the test (press P1/test).

5. Draining and drying: The filter housing is dried and drained by blowing compressed air blown through the filter cartridge.

DAX037 . . . . . Automatic filter sterilization and manual testing, WIT

Sterilization and testing of the air filter

The sterilizer has a program for automatic sterilizing and manual testing of the air filter.

NOTE: The temperature in the service room and of the water used for the test should be between 20 °C and 30 °C for a reliable test.

Filter sterilizing and testing has its own program number (see THE PROGRAM COMBINATION).

The program has the following stages:

The water t ank mu st be fille d with water befo re the p rogram is started.

1. Sterilizing: The filter is sterilized by steam flowing through the filter and the filter housing. The temperature is controlled by means of a temperature sensor located in the outlet.

2. Cooling: The filter housing is cooled with compressed air.

3. Filling filter housing with water: The space in the filter housing, upstream of the filter cartridge, is filled with water and the valves are set to the filter test position.

4. Test: The control system display reads “Filter test”. The operator must now connect the test equipment and conduct the test. When the test is complete, the operator removes the equipment and lets the program continue to run by pressing the start button.

5. Draining and drying: The filter housing is dried and drained by blowing comp ressed air blown through the filter cartridge.

DAX033 . . . . . Automatic filter sterilization, without test.

Air filter sterilization

The sterilizer is equipped with a program for automatic air-filter sterilization.

The filter sterilization has its own program number (See list of programs).

The filter is sterilized by passing steam through the filter and the filter housing. A te mperature sensor in the drainpipe controls the temperature.

After sterilization the system is gentely cooled by a restricted airflow through the filter.

DAX032 . . . . . Automatic filter sterilization and test, devided.

Air filter sterilization and test

The sterilizer is equipped with one program for automatic air-filter sterilization and a separate program for in-line testing.

The filter sterilization and test has its own program numbers (See list of programs).

As the test is to be made at a temperature below 30°C, it is for some installations recommended to run the sterilization in the evening and the test in the morning the following day.

Sterilization:

The filter is sterilized by passing steam through the filter and the filter housing. A te mperature sensor in the drainpipe controls the temperature. After the sterilization the filter is cooled below 60°C.

Test:

The testprogram is divided in three parts.

Note: Before starting the test program, make sure that the container for wetting liquid contain s enough wetting li quid. Also check that the hoses for the wetting liquid container and the collecting vessel is firmly connected.

The type of wetting li quid to be used, is described in the S ERVICE MANUAL.

1. Cooling: The cartridge is cooled, by air, to a temperature below

30°C.

DAX031 . . . . . Automatic leakage test of heat exchanger, GEV

Autom at i c leakage te st of heat e xc hanger

The sterilizer has systems and programs for automatic leakage testing of the heat exchangers mounted in the chamber.

This program has its own program number, which can be seen from

the program combination.

The program is based on the fact that the pressur e in the heat exchanger must be higher than the ambient pressure and higher than the pressure of incoming water and steam. This is in order to ensure that, for example, a leaking valve does not give a false ready signal.

The program has two major parts:

1. Flushing

The heat exchanger is flushed with cooling water for a certain time. This is done to remove any air residue from the system. The inlet and outlet valves are then closed.

2. Testing

The chamber is heated at 2 degC/min. This raises the temperature of the water in the heat exchange. The water expands and raises the pressure in the heat exchanger. When the pressure exceeds 8 bar, a pressure switch sends a signal to the control system. The temperature in the chamber is then kept constant for a further five minutes. If the pressure switch has not given a signal when the chamber temperature breaches 50 °C, or if the pressure switch operates during the five-minute constant temperature period, it is assumed that a leak has been detected. An alarm is given.

NOTE: A leaking valve or leaking coupling outside the sterilizer chamber may cause an alarm.

DAX022 . . . . . Man filter sterilization

Air filter sterilization

The sterilizer is equipped with a system for manual air-filter sterilization. This system, together with operating instructions, is described in the SERVICE MANUAL, chapter Maintenance.

DAX020 . . . . . Kihlström circular chart pen recorder

Documentation of the process

A combined instrument, built up either as circular chart pen recorder or alternatively a multi point paper roll recorder registers the chamber process temperature and pressure.

The figure below shows how four different processes may look with

a circular chart recorder.

INSTRUMENTS AND CONTROLS

FEL_A. . . . . . -

Loading side

1. Recorder for temperature and pressure. 4. Chamber pressure gauge.

2. Operating panel OP 2. 5. Emergency stop.

3. Steam supply pressure gauge. 6. Control voltage switch.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Recorder

Follow instructions in the SERVICE MANUAL.

FAV035 . . . . . . -

3 4

Loading side

1. Door blocking key. (Some models). 5. Operating panel OP 2.

2. Steam supply pressure gauge. 6. Formaldehyd bottle holder and locker.

3. Chamber pressure gauge. 7. Control voltage switch.

4. Jacket pressure gauge. 8. Emergency stop.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAX028 . . . . . -

Loading side

1. Recorder for temperature and pressure. 4. Chamber pressure gauge.

2. Operating panel OP 2. 5. Emergency stop.

3. Steam supply pressure gauge. 6. Control voltage switch.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Recorder

Follow instructions in the SERVICE MANUAL.

FAX029 . . . . . . -

Loading side

1. Recorder for temperature and pressure. 5. Jacket pressure gauge.

2. Operating panel OP 2. 6. Emergency stop.

3. Steam supply pressure gauge. 7. Control voltage switch.

4. Chamber pressure gauge.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Recorder

Follow instructions in the SERVICE MANUAL.

FAX030 . . . . . -

Loading side

1. Operating panel OP 2. 4. Jacket pressure gauge.

2. Steam supply pressure gauge. 5. Emergency stop.

3. Chamber pressure gauge. 6. Control voltage switch.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAX031 . . . . . . -

Loading side

1. Recorder for temperature and pressure. 5. Chamber pressure gauge.

2. Printer for temperature and pressure. 6. Jacket pressure gauge.

3. Operating panel OP 2. 7. Emergency stop.

4. Steam supply pressure gauge. 8. Control voltage switch.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Recorder

Follow instructions in the SERVICE MANUAL.

Printer

Follow instructions in the SERVICE MANUAL.

FAX032 . . . . . -

Loading side

1. Printer for temperature and pressure. 5. Jacket pressure gauge.

2. Operating panel OP 2. 6. Emergency stop.

3. Steam supply pressure gauge. 7. Control voltage switch.

4. Chamber pressure gauge.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Printer

Follow instructions in the SERVICE MANUAL.

FAH001. . . . . . -

Loading side

1. Steam supply pressure gauge. 4. Control voltage switch.

2. Chamber pressure gauge. 5. Emergency stop.

3. Jacket pressure gauge. 6. Door blockage key.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH002 . . . . . -

Loading side

1. Steam supply pressure gauge. 4. Emergency stop.

2. Chamber pressure gauge. 5. Door blocking key.

3. Control voltage switch.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH003. . . . . . -

Loading side

1. Steam supply gauge. 5. Control voltage switch.

2. Chamber pressure gauge. 6. Emergency stop.

3. Jacket pressure gauge. 7. Door blocking key.

4. Operatörspanel OP 1

Operator panel OP 1

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH004 . . . . . -

Loading side

1. Steam supply pressure gauge. 4. Control voltage switch.

2. Chamber pressure gauge. 5. Emergency stop.

3. Operator panel OP 1. 6. Door blocking key.

Operator panel OP 1

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7..

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH005. . . . . . -

Loading side

1. Steam supply pressure gauge. 5. Supervisor.

2. Chamber pressure gauge. 6. Control voltage switch.

3. Jacket pressure gauge. 7. Emergency stop.

4. Operating panel OP 2. 8. Door blocking key.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH006 . . . . . -

Loading side

1. Steam supply gauge. 5. Control voltage switch.

2. Chamber pressure gauge. 6. Emergency stop.

3. Operator panel OP 2. 7. Door blocking key.

4. Supervisor.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH013. . . . . . -

Loading side

1. Steam supply gauge. 4. Control voltage switch.

2. Chamber pressure gauge. 5. Emergency stop.

3. Operator panel OP 2. 6. Door blocking key.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAH014 . . . . . -

Loading side

1. Steam supply gauge. 5. Control voltage switch.

2. Chamber pressure gauge. 6. Emergency stop.

3. Jacket pressure gauge. 7. Door blocking key.

4. Operator panel OP 2.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Door blocking key

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAV001 . . . . . . _

Loading side

1. Recorder for temperature and pressure. 5. Jacket pressure gauge.

2. Operator panel OP 2. 6. Emergency stop

3. Steam supply gauge. 7. Control voltage switch.

4. Chamber pressure gauge.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

Recorder

Follow instructions in the SERVICE MANUAL.

FAV002 . . . . . _

Loading side

1. Operator panel OP 2. 4. Jacket pressure gauge.

2. Steam supply gauge. 5. Emergency stop

3. Chamber pressure gauge. 6. Control voltage switch.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

FAV003 . . . . . . _

Loading side

1. Operator panel Supervisor. 5. Jacket pressure gauge.

2. Operator panel OP 2. 6. Emergency stop.

3. Steam supply gauge. 7. Control voltage switch.

4. Chamber pressure gauge.

Operator panel OP 2

Get acquainted with the function of the press buttons and signal lights on the operator panel by studying the PACS 2000 manual in chapter 7.

Supervisor.

Get acquainted with the unit by studying the SUPERVISOR manual in chapter 8.

Emergency stop

See ”Safety devices, a survey”, chapter 1 in the OPERATOR MANUAL.

100

Getinge GEE User manual

Specifications and Main Features

Frequently Asked Questions

User Manual

INTRODUCTION

Introduction GEE

Guidelines of using ethyl ene oxid e as sterilant

The sterilization gas

Ethylene oxide as a sterilizing agent

Introduction GEC

Introduction GEV

Introduction GEVC

Introduction GE

Autoclave type GE

Introduction GED

The sterilizer

GE 2044

GEF-449 perFORMer

GE 2066

GEF 449

Safety devices, a survey

THE PROCESS

The GEV-process

The GEC-process

The ethylene oxide process

Steam/vacuum-process

Steam/vacuum-process

Chamber leak test

Chamber leak test

Documentation of the process

Documentation of the process

Documentation of the process

Documentation of the process

Documentation of the process

Sterilization and testing of the air filter

Sterilization and testing of the air filter

Documentation of the process

INSTRUMENTS AND CONTROLS