Getinge Castle OPERATING INSTRUCTIONS
EXIT MANUAL
ALLEN BRADLEY
7/16/97
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EXIT Manual
EXIT Manual
OPERATOR MANUAL
Attention symbols
Some of the warnings, instructions and advice in this manual are so
important that we used the following special symbols to draw attention
to them:
Warnings
This symbol indicates a warning. 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
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Advice
This symbol indicates instructions which are important, for
example to prevent damage to the s terilizer and/or the load.
This symbol indicates important advice and hints that
make it easier to work with the sterilizer.
OPERATOR MANUAL
TABLE OF CONTENTS
Attention symbols
1. INTRODUCTION
Introduction GE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Safety devices, a survey . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2. THE PROCESS
Steam/vacuum-process . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chamber leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
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3. INSTRUMENTS AND CONTROLS
4. OPERATION
Start-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
General advice when using the sterilizer . . . . . . . . . . . . . . . . . . . . 2
Monitoring the load temperature when sterilizing liquids . . . . . . . . . . . . 2
5. INSTALLATION
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Electricity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Steam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Compressed air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Exhaust from safety valve . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Functional test prior to use . . . . . . . . . . . . . . . . . . . . . . . . . . .11
6. OPERATING INSTRUCTION
Preoperation checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Sterilizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Close down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Blowing safety valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Program Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7. CONTROL UNIT ALLEN BRADLEY
Operating panel SLC 504 . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Push Buttons/ Indicator Lights - Load Side . . . . . . . . . . . . . . . . . . . 4
Push Buttons/Indicator Lights - Unload Side . . . . . . . . . . . . . . . . . . 5
Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Detailed screen dis p lays . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Alarm and System Messages - Troubleshooting . . . . . . . . . . . . . . . .26
System Interlocks - Horizontal Doors . . . . . . . . . . . . . . . . . . . . .36
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
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1. INTRODUCTION
Introduction GE
Sterilizer type GE is the collective designation of a range of GETINGE
high pressure sterilizers using steam and vacuum in the process for sterilization. GE-sterilizers are available with vertically or horizontally
sliding doors. Both single an d double ended types exist.
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The GE-sterilizers are intended for sterilizati on of materials in the
health service as well as in the pharmaceutical industry. The type of
materials include: instruments, utensil s, glass, plastic, leather and textiles. Some sterilizers have special programs for sterilization of hot and
cold liquids. The dominant sterilizing agent is steam at a temperature of
120-135 °C.
Adaptation to r especti ve steril izat ion req uire ment s is made pri mari ly
by selecting the type of software for the control unit. The sterilizer control unit is compu terized and prov ides for a large variety of processe s
with very good accuracy in control of the process parameters. Both real
time and set values for a process may be displayed on request.
The software which controls the processes can be preprogrammed
with cycle parameters to provide spee d and safety in the production
line. When it come s to un ique c ycles, m any pr oc ess pa rame ter s can be
modified from time to time by the operator.
Reprogramming of t he control unit can be made on site.
The automatic doors are provided with safety devices to pro tect the
operator.
The sterilizer chamber, mad e of acid pr oof stainl ess steel, i s covered
externally by seal-welded u-channel. About half of the chamber area is
covered by these u-chann els. The y serve b oth a s stif fe ning b ars for t he
1.1
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pressure vessel and a s a stea m ja cket pro vidi ng t emper atur e c ontr olled
steam heating for the chamber walls.
The GE-type sterilizers should 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.
Safety devices, a survey
The panels of the sterilizer shall prevent the operator
access to the inner parts of the sterilizer. Only specially
trained personnel have access to the inner parts.
Safety components
Every sterilizer is equipped with a number of compo nents the purpose
of which is to specifically guarantee human safety. These items are
marked with the sign below:
Electric diagrams
•
Piping diagrams
•
These components have been subject to special tests before being
accepted as safety components and must therefore not be substituted by
any make or execution not approved by Getinge/Castle, Inc.
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.
1.2
Doors
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The sign is used not only to point out important components, but also
to emphasize such other safety factors re quiring special attention as
measurements, tolerances, material etc.
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 case of an electric failure causing an opening command. The
vertically slid ing door i s actuated b y a compressed ai r cylinde r 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.
Emergency stop
Trim plates
Valves
In the front pa nel, at the side of the do or, the re is a push but ton mounte d
having dual functions:
A While actuating the door:
To stop the door motion immediately.
A push on the button releases an alarm resulting in th e door stopping its motion.
B Whil e the door is closed:
During a cycle, the process is aborted and all valves for media to the
chamber close. This releases an alarm.
Panels may be removed 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 safe temperature.
As standard, electric and pneumatically actuated valves are normally
closed (forced closed by means of a spring force when not actuated).
This prevents undesired flow through th e valves in case of power failure. A fail safe function is a chieved.
1.3
Pressure vessel
The sterilizer chamber and jacket are pressure vessels, built in accordance with regulations stip ulated by ASME.
The pressure vessels are protected against excess pressure by use of
safety valves.
The pressure vessels and safety valves comply with Section VIII of
ASME pressure vessel code.
Monitoring the pressure behind the door seal
All valves admitting medium to the chamb er are kept closed until the
pressure behind the door seal is high en ough to guar antee th e ti ghtne ss
of the chamber.
Monitoring the load temperature when sterilizing liquids
When running a liquid cycle, the doors are kept closed until the temperature of the liquid has fallen below its boiling point.
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1.4
2. THE PROCESS
Steam/vacuum-process
As the sterilizer is equipped with a vacuum pump it can serve as an ordinary steam sterilizer, suitable for sterilization of utensils, containers,
textiles etc.
The universal steam/vacuum process can be divided into pretreatment
(A), sterilizing (B) and post-treatment (C).
A
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B
C
Pretreatment
Sterilizing
It has been generally accepted that moisture is an essential element in
achieving sterility with steam. Therefore it is important that th e steam
comes in close contact with the microorganisms to be killed. Any air
present serves as an ins ulation which preve nts the contact and low ers
the temperature.
A pretreatment p hase, consisting of a nu mber of pressure varia tions
following a certai n pattern , effectiv ely remove s air from v arious type s
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 by steam-air displacement. This prevents the liquid from boiling during the decompression periods that
occurs in a pulsating procedure.
The sterilization timer starts fr om the moment when the chambe r 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 sterilizing temperature.
When sterilizing goods, in particular liquids, where the sterilizing
temperature is measured within the goods, load sensors are used. The
2.1
Post treatment
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condition for starting the sterilization timer is when the chamber sensor
and all load sensors indicate a tempe rature equal to or above nominal
sterilizing temperature
The post treatment is in tended to normaliz e the t emperatur e and moisture content of the goods. All types of goods, except liquids, are
exposed to a deep vacuum for a certain period of time.
The post treatment of aqueo us solutions sterilized in open or vented
containers consi sts of a period of natural coolin g. The pressure a nd temperature are lowered slowly until the temperature of the liqu id 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.
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 test process has its own program number (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 evacuated residual steam.
A chamber pressure rise caused by air leakage can not be detected
until the conditions in the chamber are stable. Not earlier than 5 minutes
after the vacuum pump has sto pped should the pressure and time be
measured.
A satisfactory leak test allows for a maximum permissible pressure
raise of 0.5 psig in 1 hour. A failed leak test will result in an alarm.
Test period
2.2
Air filter sterilization and test
The sterilizer is eq uipped with a pro gr a m for automatic air-fi lter sterilization.
The filter sterilization ha s its own program number (See list of programs).
The filter is sterilized by passi ng steam throug h the filter and the filt er
housing. A temperature sen so r in the piping controls the temperature.
After sterilization the system is cooled by a restricted ai rflow through
the filter.
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2.3
3. INSTRUMENTS AND CONTROLS
Load Side
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1. Jacket pressure gauge 5 Emergency stop
2 Chamber pressure gauge 6 Alarm Acknowledge
3 Operator Panel 7 Open Door
4 Control voltage switch 8 Close Door
Operator panel
Get acquainted with the function of the buttons and signal lights on the
operator panel by studyi ng the in Chapter 7 in the Operator Manual.
Emergency stop
See Safety devices, a survey, Chapter 1 in the
Operator Manuanl.
3.1
4. OPERATION
Start-up
Before start-up the operator selects a suitable program. Where appropriate the operator specifies process parameters and other information
requested by the control system.
The process is then started by pressing the start button.
Process start-up is prevented if:
there is an unacknowledged alarm.
•
the door is not closed and interlocked in accordance with the cond i-
•
tions imposed.
the self-checking of the cont rol system has detected a fault at the
•
door limit switch.
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the keyswitch for manual stepping is activated.
•
media supply (i.e. steam or water) is not available (only if the steril-
•
izer is equipped with pressure switches for this).
the jacket temperature has not been reached (only if the process
•
includes jacket heating).
Idling sterilizer
An alarm situation for an idling sterilizer stops it from being started.
Call for a technician.
•
Repeated alarms
In case repeated alarms make it impossible to end the cycle, let an
authorized technicia n end the cycle manually.
When several faults occur, onl y the last will be displayed.
Blowing safety valve
In case the safety valve on the chamber or jac ket blo ws:
Press the EMERGENCY STOP button.
•
If ineffective, cut the power with the wall-mounted disconnect.
•
Call for a technician.
•
4.1
General advice when using the sterilizer
Keep the sterilizer door closed when not sterilizing.
•
Be alert to everything that app ears unusual such as leaks, humming
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solenoid valves, jamming mechan ical devices etc. Remedy the situation before it becomes a malfunction
When loading:
Place all load sensors in the load. Be careful not to cut or run over the
•
sensor cables when loading and unloading, as well as when closi ng
the doors.
When running Steam/vacuum process:
Arrange bowl shaped articles with the hollow part down wards.
•
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Empty containers (bottles, flasks, test glasses etc.) should be placed
•
with their openings fac in g do wn wards.
Heavy goods should be placed near bottom of the chamber.
•
Monitoring the load temperature when sterilizing
liquids
If the door on a sterilizer, containing a load of liquids, is
opened before the liquid temperature has fallen below a
certain temperature, closed bottles may explode while
open containers may boil over.
The course may develop violently with great danger to
human life and technical equipment.
Safety arrangements
One or several temperature sensors in the load are sensing the temperature in the liquid. Th ese sensors keep the sterili zer doors closed until
the temperature is safely below the boiling point. An alarm will be emitted in case of a break or short circuit in the sensor.
4.2
Weekly cleaning (to be made by the daily operator)
The sterilizer should have cooled down before cleaning.
To reduce the risks for injuries, shut the power of.
1. Clean the chamber drain strainer.
2. a) Remove shelf guides and loose plates.
b) Clean the chamber internally.
c) A non chloric cleaner should be used. If particularly stubborn,
scouring powder or chrome cleaner could be used occasional ly.
Steel wool must never be used!
Sterilizers frequentl y used for sterilization of chloric solutions
demand thorough cleaning as residuals may cause serious corrosion
even in stainless materials. An acetified cleaner is best suited for
this purpose. Thorough rinsing is essential.
3. Clean the sterilizer external stainless steel surfaces w ith a normal
household cleaner that does not contain abrasive. Take care when
cleaning lacquered sur faces, texts and plastic articles.
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4.3
5. INSTALLATION
Find out the central point of gravity when lifting and transporting a packed or not packed sterilizer thereby avoiding
serious accidents.
Unpacking
• Check when unpacking the apparatus that the NB No. of its data plate
conforms with the N B No. of the documents.
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Storage
• Check that the sterilizer is undamaged. Any transportation damage
should be reporte d within seven days to the transport company that
was responsible for delivery.
• Do not remove the protective plastic film from stainless steel panels
until the installation is comp leted.
• There is certain equipment, such as expendable items; control unit;
etc. packed inside the sterilizer chamber.
Please note that these articles are specific for each sterilizer. When unpacking more than one sterilizer the articles
are not to be interchanged.
The sterilizer should be st ored in a tempera ture betw een 36oF and 104
°F and at a maximum relative humidity 95% (not condensating).
Installation
• Place the sterilizer close to but never over a drain. Leave a well sized
clearance space on both sides for good operation and easy and saf e
maintenance of the equipment. The back of the sterilizer may if necessary come up close to a wall. See also appropriat e diagrams and
drawings.
5.1
Connection
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• Arrange for escape distances, as directed from labor safety point of
view, to be contained.
• Place stainless steel floor pads under each levelling leg to protect the
floor. Adjust the legs to make the loading height fall within specified
dimension, while checking by means of a spirit level that t he sterilizer chamber bottom is horizontal.
Certain installation operations should be carried out by
authorized technicians. This is especially the case when it
comes to electricity, steam water and air.
Faulty accomplished installation may jeopardize the safety
to person and property and invalidates manufacturer's
warranty on the equipment.
Piping and electrical wiring sho uld be made in a neat manner to make
the service compartment look workman like.
• Find out the connection po ints and connection data of the sterilizer
by studying the installation drawings.
• Pay attention to local, state an d national regulations.
• Remove impuriti es by blowing through all pipe s to be connected to
the sterilizer.
• Insulate hot pipes, where necessary, to avoid injury.
• Mark pipes and electrical leads.
Install shut-off valves in the supply lines in an easily accessible location near the equipment so as to avoid risk areas
when using these. Due to the risk of injury an un-accessible area of the service com partment is not a suitable place.
5.2
Electricity
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Before welding on or near-by the sterilizer, the boards of
the control system have to be isolated!
Disconnect all plug-in connectors from all PCB’s!
The electric components o f the control unit will tole rate supply line
voltage variations of ±10%. Greater fluctuations demand that a voltage
stabilizer be introduced between the sterilizer automatic fuse and the
control equipment. The latter will cause an inductive load on the stabilizer this should be well over sized (minimum.5 kW). The frequency
deviation may amount to ±1%.
• Check that all electric wire connection screws are tig htened.
Connect the sterilizer to an electric 60 Hz; 3 Ph/ 208 - 480
volts (depending upon pump size) + ground, through a
closely situated disconnect.
The stated voltage is for various versions of the sterilizer.
Check on the equipment arrangement drawing and the utility data sheet for the required electrical connections.
Those documents also give information about power and
fuse ratings that may be important for choos ing the correct
size of cables.
Units equipped with vacuum pumps
Check by manual operation of the direct o n line starter of th e vacuum
pump, that the direction of rotation conforms with the arrow on the
pump housing.
Running the shaft seal dry will destroy it in a few seconds.
Change any two of th e main supp ly wires on their co nnecti on te rmin al
to reverse the direction of rotation.
5.3
Water
Cooling water for heat exchanger
The sterilizer has a pressure gauge connected to the coolin g wat er supply pipe. It is no rmally situated in the service area. The cooling water
must not be corrosive, nor must it contain abrasives or scaling particles.
The water salt conten t should not ca use scaling as a resu lt of the temperature. If the cooling water is to be recirculated, the pressure in the
return pipe should be at least 250 kPa (36 psig) lower than in the supply
pipe.
Connect the sterilizer via a shut off valve to a cooling water supply
•
line where the pressure should be a minimum of 350 kPa (50 psig)
and a maximum of 600 kPa (87 psig). A non return valve if necessary
should be supplied by the customer if not otherwise stated in the contract.
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Pump service liquid
TEMPERATURE
Optimal pump operation, for capacity and vacuum depth, is achieved by
a water temperature of 60
of capacity and vacuum dep th is acceptable.
PRESSURE
Connect the sterilizer to a supp ly lin e wi th a mini mum pr essure o f 250
kPa (36 psig) and maximum pressure of 600 kPa (87 psig).
HARDNESS
In order to minimize the sterilizer maintenance and service expenses the
water hardness should not exceed 4 dH. A water softener is recommended where the water is harder than this.
o
F. This temperature can be exceeded, if loss
5.4
Connection
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A gauge is not required but contributes to easier supervision of the
installation.
1 Main line 2 Shut-off valve
3 Strainer 4 Non-return valve
Steam
5 Pressure gauge 6 Anti-siphon device
Sterilizers not equipped with a built in steam generator must be connected to a central steam supply.
The user is obligated to arrange for safety valves in the
steam supply line as directed.
The effectiveness of a steam st eriliz ation is ver y much de pendent on
the characteristics of the steam used. Therefore some basic demands
should be raised on the quality of steam supplying the sterilizers.
Steam generators based upon evaporation from high pressure hot
water should not be used since the steam produced is of inferior quality
for sterilization purp oses.
Steam Quality
1. Solid particles such as welding pellets, graphite, rust flakes, sand
etc. must not be present since the steam comes in physical contact
with the goods to be sterilized.
2. Liquids, except from steam condensate, must not be present.
5.5
3. Gases will prevent a close contact between the steam and the micro-
organisms and should be minimize d as foll ow s:
· Hydrazine (N2H4), NMT 0.11 mg/kg steam.
· Ammonia (NH3), NMT 5 mg/kg steam.
· Air and/or no n-condensa ble gases, NM T 7 ml per 200 ml cond ensate, formed by the steam-air/gas mixture.
4. Other chemicals such as softening residuals and similar particulates
must not be present in sterilizing steam.
· Salt content of NMT 1 mg/kg steam.
Analysis of condensate
An analysis of the condensate from the steam should provide a gauge of
purity. The following should not occur in concentrations exceeding the
values given in ppm condensate:.
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Pressure
Evaporation residuals 1.0ppm of which:
Silicone as SiO2 0.01 ppm
Iron 0.1 ppm
Cadmium 0.005 ppm
Lead 0.05 ppm
Other heavy metals 0.1 ppm
Chloride 0.1 ppm
Phosphate 0 ppm
Recommended pH val ue = 5 - 7
Suitable conductivity < 3 µS/cm (at 68°F)
Suitable hardness ≤ 0.1 dH
Getinge sterilizers should be supplied with steam, pressure in the range
of 36 to 43.5 psig as indicate d by the steril izer pressure gaug e marked
“Steam supply”.
Consult the installa tion drawing for appropriate information.
5.6
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