Getinge GE 6610 AC-1 User manual

GE 6610 AC-1

Reporting an accident or incident
If an accident or an incident associated with the occurs, this must be
reported immediately in writing to the address below. The report must
be used to identify the cause of the accident or incident and to what
extent the occurrence was due to the unit
The unit is a product in the Getinge range.
The unit may also be a sterilizer that is a medical engineering product
and which conforms to the EU medical devices directive, or which is
constructed in a similar way to a medical device. Under the medical
devices directive, the manufacturer must investigate the cause of
accidents/incidents that occur and report them to the authorities
concerned.
The investigation may lead to changes in new or already delivered
devices or in instructions and guidance.
The following circumstances must be reported:
1. circumstances that caused the death of a patient, user or someone
else, or that caused serious deterioration in the health of a patient,
user or someone else.
2. circumstances that might have caused, the death of a patient, user or
someone else, or that might have caused serious deterioration in the
health of a patient, user or someone else.
The following information is required:
The manufacturing number of the unit (on a label in the electrical
cabinet), Date/time of event, Description of event, Consequences of
event.
Contact: Name, Phone number, Address:, E-mail:
The information must be sent by letter or fax to:
GETINGE STERILIZATION AB
For the attention of: Quality Manager
Box 69
31044 GETINGE
Sweden
Fax: [phone]
Use this information when reporting incidents and
accidents involving the unit.

Attention symbols
I 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. The symbols used are as follows:
Warnings
Instructions
Advice
Symbols on the unit
Hot surface This symbol gives warning of a hot surface.
This symbol indicates a warning in the text of the manual.
The nature of what the warning relates to is such that it
may result in more or less severe injury and in certain
cases mortal danger.
The symbol is also used to highlight safety components,
etc. See “Safety devices - an overview” under
“Introduction” in the DESCRIPTION OF OPERATION or
under “Maintenance” in the SERVICE MANUAL.
This symbol highlights instructions that are important for
avoiding damage to the unit and/or load, among other
things.
This symbol indicates important advice and hints that
make it easier to work with the unit.
SS
S

SERVICEMANUAL
TABLE OF CONTENTS
INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
General requirements to be met by the installation location. . . . . . . . . . . . . . . . . . . . 7
Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
ESD (Electrostatic discharge) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Incoming media. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Connecting water. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Steam. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Compressed air quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Air connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Drain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Outlet from safety valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Ventilation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Response for pressure vessel and safety valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Functional check-up prior to use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
FUNCTION CHECK. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29
Before use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Overview of safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Maintenance plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Cycle counter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
The ECO water-saving system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
ADVICE AND INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Manual interventions in the process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Manual stepping with keyswitch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Faulty analog sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Pressure sensor fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Manual control by manually actuating the control valves. . . . . . . . . . . . . . . . . . . . . 42
External safety interlock fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Backup battery fault . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Restoring software from E-PROM (cold start) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Manual door opening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Power failure alarm with door open . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
User-programmable functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Safety valve check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
THE DOOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .53
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Seal between door and chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Media to the chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Checking the door action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Checking and adjusting the door position. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Removing the door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
The door seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Lubrication and replacement of the door seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Replacing the door cylinder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Replacing the piston seal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Door safety arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Blocking the start and opening the door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Blocking the media supply to the chamber. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Safety interlocking of the door opening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
CONTROL UNIT PACS 3000. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Operating panel type OP 30 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Indicators and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Operator menu tree . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Description of operator menu tree. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
System menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
I2C-link faults on PACS 3000 modules.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Technical data, PACS 3000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
COMPONENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Illustration on drawings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Panel-mounted printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Vacuum pump LEM 50. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Pressure transmitter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Single circuit pressure switch 469 56 96. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Solenoid valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
Pt 100 sensor (RTD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
Piston valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
Filters and strainers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Restrictors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Soldered plate-type heat exchangers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
SCRAPPING INSTRUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

7
INSTALLATION
This pre-installation instruction covers the information needed to pre-
pare the installation site, before delivery of the unit.
With the delivery ofthemachine a specificinstallation instruction will
be enclosed. A copy of the specific instruction is also enclosed in the
manual.
The specific instruction may also cover details such as:
•Unpacking
•Rigging and transportation within the facility
•Reassembly of the dismounted equipment
•Functional test prior to use.
General requirements to be met by the installation
location Use Getinge Sterilization AB’s installation drawings for design and
building purposes when determining the necessary dimensions and
design. Experience has shown that particular attention should be paid to
the following points.
•The ceiling height in the service room must be sufficient to allow
space for all equipment according to the installation drawing.
•The service room must have good lighting and be ventilated. For
requirements regarding ventilation, see the special section on this
topic in this instruction manual.
•All dimensions relating to foundations, floor pits, wallopenings, etc.
refer to finished dimensions. These dimensions must be complied
with when floor, wall and ceiling linings have been installed.
•When choosing the wall covering in the service room it should be
kept in mind that the room may be filled with steam the event of a
failure.
•The equipment must be set up so that the distance to the nearest
workplace or treatment position is more than 1.5 meters (5 foot).
•The floor in front of the door(s) of the sterilizer must be flat and level
within in a zone as shown in the diagram below. When installing
several sterilizers that are to be served by a common loader, the
width of this area must be the same as that of the entire installation.

8
These requirements, and others such as those relating to floor
loading, are specified in more detail on the installation drawing.
Installing a sterilizer in a wall opening
•There must be no trim, baseboards or similar objects within
approximately 5 centimeters (2 inch) from the edge of the opening
next to the wall opening for building in the sterilizer.
•Sterilizers installed in wall openings should be sealed to the wall in
order to separate the sterile and non-sterile sides. The edges of the
wall opening and the transition between the front plates of the
sterilizer and the wall should be finished in a properly hygienic
manner.
•Sterilizers with vertically-operating doors: These models have a
generous gap between the front plates of the sterilizer and the wall
opening. The gap must be covered with suitable fitting pieces.
Getinge sells an add-on system for this purpose.
•Sterilizers with horizontally-operating doors There are two
variants: eitherthefrontplates aredesigned tolieoutsideandoverlap
the wall, or a gap is left between the wall and the plates. The version
with the gap must be sealed with silicone compound or similar. The
outside of the front plates meets the wall in this version so that a
smooth transition is obtained. The installation drawing shows the
specific installation method for a particular sterilizer.
Find out the central point of gravity when lifting and trans-
porting a packed or not packed sterilizer thereby avoiding
serious accidents.

9
Unpacking
•Check when unpacking the equipment that the order No. of its data
plate conforms with the ordering No. of the documents.
•Check that the sterilizer is faultless. Any transportation damage
should be reported 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 completed.
•There is certain equipment such as expendable items, control unit,
operating instruction and list of programs by-packed the sterilizer
inside the chamber. The two latter are to be posted where easily
observed by the operator at work.
Storage The unit must be stored in a temperature between 2 and 40oC (35 and
105°F) and at a maximum relative humidity 95% (non-condensing).
Installation •Observe national and local regulations concerning service space.
•Make sure that the clearance distances required by health and safety
regulations are provided.
Please note that those articles are adapted for each steril-
izer. When unpacking more than one sterilizer the articles
are not to be interchanged.

10
Connection
Pipework and electrical wiring should be done in a professional manner
so that the service compartment looks workmanlike and provides a
practical workplace which minimizes the risk of accidents.
•Find out the connection points and connection data of the equipment
by studying the installation drawings.
•Pay attention to local regulations.
•Remove debris by flushing or blowing through all pipes that will be
connected.
•Insulate hot and very cold pipes.
•Mark pipes and electrical wiring.
Electrical
Components in the control system ofthe installation and other electrical
components tolerate supply voltage variations of -10/+5 %. If greater
voltage variations are likely, a mains voltage stabilizer will have to be
provided between the mains cicuit breaker of the installation and the
control equipment. As the equipment will present an inductive load to
the stabilizer, the stabilizer should be well oversized (at least 500 VA).
Permitted frequency deviation ±1%.
Certain types of installation work, water and electrical, for
example, should be done by authorized technicians.
If the work is not done properly, injury and damage may
result.
Faulty installation work invalidates the warranty on the
product supplied.
Install shut-off devices in the media supply lines near each
unit, so that the operator can use them without passing
through a risk area. The inner part of the service
compartment is not a suitable place for this.
Before welding on or near the sterilizer, ALL plug-in leads
must disconnected from ALL the PCBs of the control
system.

11
•Check that all terminal screws are tight..
•If the building where the equipment is installed has a separate
equipotential bonding system, a wire must be run from this to the
earthing (grounding) terminal of the surge protection. The surge
protection is located in the terminal box. See the wiring diagram.
•If the control system of the equipment is to be connected to a
standalone computer, the power supply to the computer should be
taken from the the same distribution board as the equipment is
connected to. Common supply is important in order to avoid
potential differences and therefore the risk of damage to the
electronic circuits of the equipment.
•A printer used to print from the equipment must be
connected in accordance with the wiring diagram. Normally
it will take its supply directly from the electrical system of
the equipment. Some equipment has sockets for a printer. If
so, these are marked with the symbol for heavy current and
the text E110and 230 V. The signal cable is connected to a
multipole socket marked E110.
•A printer used elsewhere must be powered from the same
distribution board as the equipment. Common supply is important in
order to avoid potential differences and therefore the risk of damage
to the electronic circuits of the equipment.
•The supply cable to the sterilizer should be run so that the
temperature rise in the cable due to its insulation and ambient
temperature remains within permissible limits.
•The routing and overcurrent protection of the supply cable must be
such that the sterilizer cannot be subjected to short-circuit currents
exceeding 6 kA.
•The following requirement is applicable in countries there IEC
61000-3-3 applies: Equipment with a current less than 16 Amps on
each phase which is supplied from a public power distribution
system applies tothe directive. Thepublicpower distribution system
General:Connect the equipment through a nearby multi-
pole lockable, safety-marked switch to a three-phase
supply with non-disconnectible protective earth
conductor.
In the planning phase: Concerning voltage and frequency,
mains cicuit breaker ratings and wiring sizes, see the
document “Technical data”.
When connecting the equipment: connect as shown on the
wiring diagram. The drawing number is given in the
documentation of the equipment.

12
must at least be capabable to provide 100 Amps on each phase or
have a impedance of Z[ohm]=0,15+0,15*i.
•Load-breaking switches in accordance with IEC 898, with B or C
characteristic, are recommended for circuit protection. If such
switches are not available, protection can be provided by IEC 269-1
fuses, characteristics gG or gM.
•Vacuum pumps, fans, pumps and motors located in separate rooms
away from the common service area of the installation must have
theirown individualmulti-pole,lockable, safety-marked switches.A
switch ofthis descriptionmust alwaysbe installed close to themotor.
•Vacuum pumps and pumps for liquids: First make sure that the
feedwater tanks and pipework are filled with water. Then check that
the direction of rotation of the pump is correct by briefly operating
the pump contactor by hand. Correct this as shown in the drawing
below.
•Fans and three-phase motors: check that the direction of rotation
is correct by briefly operating the motor contactor by hand. Correct
this as shown in the drawing below.
•Correcting the direction of rotation: Swap two of the phase wires
in the supply cable between the motor and the contactor. For some
equipment the “contactor” may take form of a frequency converter
or soft-starter.
•It isrecommended thatthe three-phase supply should beprotected by
an earth leakage circuit breaker with a 300 mA trip current.
ESD (Electrostatic discharge)
ESD damage ESD is an overall term describing how electronic circuits are damaged
by the static charging to which they are exposed when they come into
contact with electrically charged objects. Virtually all non-earthed
objects in the world around us have a static charge. Equipment and peo-
ple are imperceptibly charged by friction in the air or between shoes and
Running the shaft seal dry could destroy it in just a few
seconds.
ESD damage in installation and servicing may destroy the
electronic equipment. Read the instructions below
BEFORE starting work.

13
floor in ordinary walking. This charge is transferred to the electronic
circuits when they are touched.
Any damage that occurs to the electronics may be difficult to detect
and trace. It varies from immediate destruction of a circuit so that it no
longer works at all to insidiously affecting operation so that perfor-
mance is not maintained. The circuits may even appear to be undam-
aged and then later disintegrate inexplicably.
Most replacements of electronic boards where the fault cannot be
explained and is blamed on uneven quality are probably due to ESD
damage.
Requirements for protection in installation and servicing
GETINGE has ESD protection integrated into the production and test-
ing of electronic equipment and also requires ESD protection to be used
after delivery for the warranty to apply.
Damage usually occurs after delivery if electronic boards are stored in
non-ESD-approved packs, if electronic boards are placed on non-ESD-
protected work surfaces or if people not wearing ESD protection touch
them. Simple equipment can be obtained for all these situations which
prevents charging and therefore ESD damage. Contact your local dis-
tributor of ESD protective equipment or GETINGE After Sales.
Practical requirements
•Keep electronic boards only in screened and ESD-approved
(marked) bags.
•Use ESD pads connected to earth in accordance with the manufac-
turer's instructions to hold disassembled or new electronic boards
during assembly work.
•Do not touch electronic boards with tools that may be charged, e.g.
screwdrivers with a plastic or wooden handle. Use earthed tools if
necessary.
•Always use an ESD wrist band connected to earth inaccordance with
the manufacturer's instructions when working in the electronic
enclosure or when handling boards.
•Newer keep foreign objects such as drawings or plastic pockets
inside the electronic box.
•Test the ESD protective equipment regularly.

14
Incoming media
General safety requirements for supply lines
The document Technical Data states permitted pressure levels for all
incoming media.
If the stated pressure of the medium does not exceed the design
pressure of the pressure vessel , the equipment does not normally have
protection against excessive pressure for that medium.
Where the supply medium pressure (as stated in Technical Data)
exceeds the design pressure of the pressure vessel, the equipment is
protected against excessive pressure for a well-defined inflow rate of
that medium. The protection takes the form of a specific safety valve
and suitable designed restrictions and valves in the internal pipework.
To ensure that the equipment is only supplied at the permitted
pressure levels, the user must accept liability for fitting the supply lines
with reducing valves and safety valves in accordance with the
regulations.
oC (60°F). This temperature may be exceeded by 5°C (10°F) if reduced
depth of evacuation and pump capacity can be accepted. This applies
primarily to sterilizers of the EN model, i.e. designed for the European
market.
Certain models intended primarily for tropical climates can easily be
modified for use with water temperatures up to 35oC (95°F). This topic
is covered under "Connection and pressures" in this section and in the
section headed "Customer-programmable functions" in the SERVICE
MANUAL.
HARDNESS
To minimise sterilizer service and maintenance costs, the water
hardness should not exceed 4dH / (0.7mmol/l) / (70 ppm). A water
softener is recommended where the water is harder than this.
Whether or not the sterilizer is equipped with a safety
valve, the user must install correctly dimensioned safety
valves in the supply lines for incoming media.
Note that the pressure vessel safety systems cease to
operate if the pressure of any medium exceeds the range
stated in Connection data. This results in a RISK OF
BURSTING.

15
Driving liquid for the vacuum pump
TEMPERATURE
The highest water temperature for maximum pump performance is 15
oC. This temperature may be exceeded by 5 degC if reduced depth of
evacuation and pump capacity can be accepted. This applies primarily
to sterilizers of the EN model, i.e. designed for the European market.
Certain models intended primarily for tropical climates can easily be
modified for use with water temperatures up to 35 oC. This topic is
covered under "Connection and pressures" in this section and in the
section headed "Customer-programmable functions" in the SERVICE
MANUAL.
HARDNESS
To minimise sterilizer service and maintenance costs, the water
hardness should not exceed 4dH (0.7mmol/l). A water softener is
recommended where the water is harder than this.
Cooling water for heat exchangers
TEMPERATURE
The highest water temperature for satisfactory performance is 15oC
(60°F). This temperature may be exceeded by 5°C (10°F) if reduced
performance is acceptable.
WATER QUALITY
To minimise service and maintenance costs, the water hardness should
not exceed 4dH / (0.7mmol/l) / (70 ppm). A water softener is
recommended where the water is harder than this. The cooling water
must not be corrosive, nor must it contain substances that are abrasive
or which form deposits. The water salt content should not be so high as
to cause scaling as a result of the temperature.
Connecting water
Common water supply
Some equipment in the basic version is supplied with water from a
single common connection to the sterilizer. This means that the water
temperature and hardness are the same for all the water-using
equipment.
The water must always be colorless, with no solid contaminants such
as sand, flakes of rust, graphite, etc. The content of other substances
may vary, as previously mentioned, and the temperature should be
suited to the requirements of the vacuum pump sealing water. If the
sterilizer is connected to the drinking water supply, requirements for

16
Back flow prevention must be observed; see Connecting with reverse
siphon protection.
Connection with reverse siphon protection
Any connections made to a drinking water supply must comply with
national and local regulations. In countries where EU regulations apply,
the national requirements will gradually be complemented by
harmonised EN standards, regulating the connection and prescribing
equipment for such purposes as reverse siphon protection.
Reverse siphon protection
When the equipment is installed, an approved (and, in certain cases,
type-tested) reverse-siphon protection device must be fitted in the
supply line. Details of the particular types of reverse siphon protection
devices that must be used, and how they must be installed, are regulated
by the responsible authorities in each country.
•In the absence of specific rules for connection, we recommend that a
connection to the drinking water supply should be arranged as
follows:
•The above components should be supplied by the customer unless
the contract states otherwise.
Pressure
•For service water systems: Normally the equipment is supplied via
a shutoff valve to a water pipe system with a positive pressure of 3.5
to 6 bar(e), equivalent to 350 to 600 kpa(e) or 50 to 90 psig. Models
for certain markets and models that can be converted for tropical
1 Main supply line 2 Shut-off valve
3 Filter 4 Non-return valve
5 Pressure gauge,
including water
pockets and
isolating valve
6 Reverse siphon protection
7 Connection to sterilizer
H > 300 mm
1
2
3
4
5
6
7

17
conditions can be connected to pipe systems with a pressure as low
as 1.0 bar(e), equivalentto 100 kpa(e)or 15 psig. Precise information
about pressures, temperatures, consumption rates and connection
size for each medium is given in the Technical Data document. In
case of doubt, Technical Data always takes precedence.
•For closed systems: Normally the equipment is supplied via a
shutoff valve to a circulating system with a positive pressure of 3.5
to 6 bar(e), equivalent to350 to600kpa(e) or 50to90 psig. Notethat
the pressure in the return line must normally be atleast 1.0 barlower,
equivalent to 100 kpa lower or 15 psi lower . Precise information
about pressures, temperatures, consumption rates and connection
size for each medium is given in the Technical Data document. In
case of doubt, Technical Data always takes precedence.
Steam The result of a sterilization is very dependent on the nature of the
steam used. The steam must therefore meet certain quality
requirements.
Steam generators based upon evaporation from high pressure hot
water should not be used since the steam produced is of inferior quality
for sterilization purposes.
Minimum cleanness requirements
The following are minimum cleanness requirements, but may be
regarded as normal requirements to be met by steam for heating in heat
exchangers and jackets. It is the user’s responsibility to choose the
steam quality for sterilization, taking account of local regulations and
official requirements.
1. Solid particles such as welding pellets, graphite, rust flakes, sand
etcmustnotoccur, sincethesteamcomesintophysicalcontact with
the goods to be sterilized. These impurities may also block steam
traps and chokes.
The Technical Data document states a permitted pressure
range for all incoming media. Always check that the
equipment is connected to supply lines in which the
pressure is within the correct range.
Note that the pressure vessel safety systems cease to
operate if the pressure of any medium exceeds the range
stated in Technical Data. This results in a RISK OF
BURSTING!

18
2. For the same reason, liquids must not occur, except very small
amounts of water.
3. Gases will prevent close contact between the steam and the micro-
organisms to be killed. They must be kept below the proportions
below.
·Hydrazine (N2H4) max 0.11 mg/kg (ppm) steam.
·Ammonia (NH3) max 5 mg/kg (ppm) steam.
·Air and/or non-condensable gases max 7 ml (0.25 oz) per 200 ml
(6.75 oz) condensate, formed by the steam-air/gas mixture.
4. Other chemicals such as softener residue and similar substances
must not occur in sterilizing steam.
·Salt content max 1 mg/kg (ppm) steam.
Analysis of condensate
An analysis of the condensate from the steam gives an idea of its
cleanness as regards other substances. These substance should not occur
in concentrationsexceeding the values given in mg/kg condensate in the
table below.
Steam of the quality specified below under Process steam is
recommended for the sterilization of products that come into direct or
indirect contact with the human blood circulation, where there are very
stringent requirements for cleanness.
Process steam In accordance with cGMP, the chemical content of the steam must
conform to the requirements for WFI of the European Pharmacopoeia
Evaporation residues 1.0 mg/l (ppm), of which:
Silicon in the form of SiO20.01 mg/kg (ppm)
Iron 0.1 mg/kg (ppm)
Cadmium 0.005 mg/kg (ppm)
Lead 0.05 mg/kg (ppm)
Other heavy metals 0.1 mg/kg (ppm)
Chlorides 0.1 mg/kg (ppm)
Phosphates 0 mg/kg (ppm)
Recommended pH = 5 - 7
Suitable conductivity < 3 µS/cm [at 20 °C (68°F)]
Suitable hardness ≤0.1 dH (1.8 ppm)

19
(EP) 3rd edition 1997, United States Pharmacopoeia (USP XXIII) and/
or another local pharmacopoeia.
Alternatively, steam with a chemical content equivalent to clean steam
for sterilization as per HTM 2031 may be used if the user’s local
regulations and official requirements allow it.
Pressure
A See the document “Technical Data” for correct information about
steam pressure.
B Permitted pressure variations max ± 0.1 bar (equivalent to ±10.0
kPa or ± 1.5 psi).
Moisture contentSterilizers should be supplied with dry saturated steam. The ideal
physical state “dry saturated” is difficult to maintain in a practical
application, and measurement/control of the moisture content of the
steam is tricky .
Applying the advice given below, which is based upon practical
experience, will generally result in steam with a satisfactory moisture
content. This means that it is notsuperheated either. Superheating of the
steam is highly undesirable in connection with sterilization because it
does not contribute the humidification necessary to kill micro-
organisms.
Methods and values for determining the quality of the steam and the
degree of superheating are described in standard EN285, for instance.
Practical arrangements
1. Connect the equipment to a line in which steam is consumed
continuously. Long branch connections should be avoided.
2. Choose the appropriate pipe size from the table below. If more than
one piece of equipment is connected to the same line, a diversity
factor of 0.8 or higher may be applied.
If the steam supply line pressure exceeds the steam
pressure stated in Connection data, the user must install a
pressure reduction unit with a suitable safety valve which
has sufficient blow-off capacity for the amount of steam
supplied.
Steam pressure Highest design gas velocity

20
The specific steam pressure of the equipment is given in the
document “Technical Data”. If the installation is to be connected to
a steam supply at a different pressure, the table can be used for
guidance. If in doubt, contact Getinge Sterilization AB.
3. The steam supply pipes should have a fall of at least 1:50 (1/4 inch
per foot) in the direction of flow.
4. Install reducing valve(s) in the supply line if the pressure is higher
than that specified in Technical Data. The steam pressure upstream
of the reducing valve should not fluctuate more than 10%.
Do not reduce the pressure by a factor smaller than 0.5 in one step.
Use a second reducing valve for greater reduction ratio. Each
reducing valve must be followed by a safety valve.
The drain line of safety valves should have at least the same
dimension as the valve blowoff opening and must not contain shut
off devices or chokes. Water pockets formed in the piping, must be
drained.
5. There must be no chokes or restrictions placed in horizontal pipes.
6. Fit the last reducing valve not more than 6 m (20 ft) pipe length
away from the sterilizer, but not closer than 4 m (13 ft) if the
maximum reduction ratio (2:1) is used.
7. The last condensate removal device (see figure below) should not
be placed more than 1 meter (3 feet) away from the sterilizer steam
connection. If this is not possible for practical reasons, a steam
dryer can be installed directly at the steam connection.
8. There should be no steam consumers other than sterilizers, steam
converters or treatment stations (WSSD) connected downstream of
the last reducing valve.
2.5 [bar (e)], 36 [psig] 38 [m/s], 125 [feet/s]
3 [bar (e)], 45 [psig] 35 [m/s], 115 [feet/s]
4.5 [bar (e)], 65 [psig] 30 [m/s], 100 [feet/s]
6 [bar (e)], 90 [psig] 25 [m/s], 80 [feet/s]
If the steam in the supply line is wet, include condensate
removal as shown in Figure "A" just before the reducing
valve, as shown in the sketches below.
If the reducing valve is positioned much more than 6
meters (20 feet) from the sterilizer, include condensate
removal as shown in Figure "A" just before the sterilizer.