Getinge HS 6613 AR-2 User manual

HS 6613 AR-2
TEHRAN NAFT HOSPITAL
2511022-150-01

TABLE OF CONTENTS
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Attention symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reporting an accident or incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
HS 66. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Overview of safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
THE PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
The steam sterilizing process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Maintenance program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
General advice when using the sterilizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Weekly cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Approved consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
OPERATION INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Daily preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
CONTROL UNIT PACS 3500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Operating panel type OP 10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Control panel type OP 20 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Indicators and controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
The operator’s menu tree. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Description of operator menu tree. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Program combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Program combination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

1
PREFACE
This USER MANUAL, contains all the information you need in order
to safely operate your GETINGE STERILIZATION AB equipment.
Please read and follow the entire manual carefully, and please pay
special attention to the framed warnings and caution remarks. See
“Attention symbols” under Safety.
In the event of an accident or incident you are obliged to report this. See
“Reporting an accident or incident” under Safety.
GETINGE STERILIZATION AB shall not be liable for any damages,
directly or indirectly, due to actions, which are not in accordance with
this manual.
By following this manual you are ensured quality equipment for many
years ahead. Should any unforeseen problems occur, you are of course
welcome to contact our local representative.

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3
SAFETY
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. 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 USER MANUAL or under Maintenance in the
TECHNICAL 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

4
Reporting an accident or incident
If an accident or an incident associated with the sterilizers 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.

5
INTRODUCTION
HS 66 HS 66 is the designation of a series of GETINGE high-pressure
autoclaves with vertically sliding automatic doors, all with the door
opening 660 x 660 mm
There are both stand-alone and built-in versions.
The autoclaves are intended for sterilization of materials in the health
service as well as in industry. They are adapted to their particular
functions by the choice of control equipment. This is built up around a
microprocessor and therefore provides a very large number of process
types, all characterized by exceptional accuracy in controlling 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.

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The dominant sterilizing agent is steam at a temperature of 121 -
134 °C. Material that is damaged by this temperature may be sterilized
in some autoclave models in formalin vapour at 55 - 80°C.
Most types of items can be treated in the HS 66-autoclaves, using
adapted programs:
Instruments, machine parts, glass, plastic, leather, textiles, hot or cold
liquids in open or vented containers and small rigid pressure-tight
containers filled with liquids.
European standard EN 285 (Australia/New Zeeland, Standard AS
1410) specifies the use of fixed programs only. However, the control
equipment of HS 66-autoclaves allows the programs to be made
variable during the time testing is in progress.
As not only the processes but door operation too are controlled
automatically, the step to full automation of thehandling of sterileitems
is not a long one. The control unit is therefore prepared for controlling
an autoclave having a GETINGE ASF automatic loading and unloading
unit.
As with other GETINGE double-jacketed autoclaves, the external
surface of the chamber is more than half covered by 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 makes all welds accessible for visual inspection after the
thermal insulation has been removed.
A vacuum pump of the water-ring type removes air, steam and
condensation from the chamber and door-gasket groove. The sealing
water of the pump is taken from an open tank which in some cases also
supplies the feedwater pump, on autoclaves with a steam generator,
with water.
The condenser between the chamber and vacuum pump converts
waste steam to water. This reduction of the pump handling volume
contributes greatly to improving pump efficiency and protecting the
pump and waste pipes against high temperatures.
A well-damped discharge system after the vacuum pump and well-
dimensioned thermal insulation around the chamber mean that the
autoclave affects the surroundings to an insignificant extent and is
therefore easy to position.

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HS 66-autoclaves have to be supplied with electricity, cold water,
compressed air and steam. When steam is supplied from a central
steam-producing plant, its distributionsystem is required to be correctly
pressure-reduced, protected by a safety valve and produce a quality of
steam which is suitable in the context of sterilization. (For some
versions the pressure reducer is already fitted)
If the steam is not suitable in the context of sterilization, a steam
generator can be installed inside the trim plates on all models. The task
of the steam generator is to generate pure steam using the centrally
produced steam.
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
trim plates on all models.
Overview of safety devices
Additional information about the above safety components are given in
the “Safety checks”, “Technical data” and “Periodic maintenance”
sections of the TECHNICAL MANUAL.
Safety components
Every unit is equipped with a number of components with the specific
purpose of ensuring the safety of personnel. These items are marked
with a warning triangle below in the following documents:
•electrical diagrams
•pipework diagrams
•spare parts lists
These components have undergone special tests before being
accepted as safety components. For this reason, they must not be
replaced with components of any make or design that has not been
approved by GETINGE.
Cladding and front panels must preventaccess tothe parts
of the installation that are normally accessible only to
trained personnel.
General access to an installation supplied without
cladding, which should normally only be maintained by
trained personnel must be prevented. A convenient way of
preventing access is to install the equipment in a lockable
area.

8
It is of the highest importance that the operational reliability of these
components is continuously upheld during their entire service life.
The signs are used not only to indicate important components, but also
to draw attention to other safety factors that call for special attention,
such as dimensions, tolerances, materials, etc.
Doors The doors are closed and locked while the process is running and remain
locked in the event of media loss. The doors cannot be opened until the
pressure in the chamber has been equalized with the ambient pressure,
not even if fault management gives an opening command. The sliding
doors are operated by a compressed air cylinder which has a severely
throttled inlet. A drain valve with a considerably greater flow capacity
than the inlet is located in the bottom of the cylinder, which is pointing
upwards. Objects that obstruct the upward motion of the door press
down a metal plate which opens the drain valve, causing the door
motion to stop. This prevents operator injuries and material damage. A
support latch holds the door so that it does not open if the pneumatic
operating cylinder loses pressure. When the pressure of the compressed
air is so low that the door cylinder cannot support the weight of the door,
the air is not capable of pulling away the support latch.
Emergency stopIn the front panel, at the side of the door, there is a pushbutton with these
functions:
AOn door operation.
to stop the door motion immediately during door operation.
Pressing the button triggers an alarm. This alarm stops the door
immediately:
BWhen the door is closed
The current process is aborted and all valves for media to the
chamber are closed. This also triggers an alarm.
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 under
"Cleaning the chamber" in the Operation chapter.
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.

9
Stainless steel surfaces within reach of the operating personnel are
insulated and cooled to a harmless temperature.
Valves If the equipment has electrically and/or pneumatically actuated valves
they are normally 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.
Pressure vessels
The sterilizer chamber and jacket are pressure vessels, designed and
built in accordance with standards laid down by official bodies charged
with monitoring this area of safety.
The connected supply lines from external steam, water or compressed
air networks must be protected against excessive pressure by safety
valves. The sterilizer supplier is not responsible for these valves.
Permitted supply media pressures are stated in “Technical data”.
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.

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11
THE PROCESS
The steam sterilizing process
The universal steam autoclaving process can be divided into three main
phases:
A Pre-treatment
B Sterilizing
C Post-treatment
Pre-treatment It has been found that moisture is an essential element in achieving
sterility with steam. It is therefore important that the steam comes into
close contact with the micro-organisms to be killed.
A pre-treatment 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. Depending on the equipment of the sterilizer, steam may pass
through before the evacuations.
Air removal when autoclaving liquids in open containers is by
applying a vacuum or by flowing steam, to ensure that the liquid does
not boil during the decompression periods in a pulsating procedure.
Sterilizing For sterilizers equipped with a computerized control unit, the sterilizing
time starts at the instant in the pre-treatment phase of the process when
the chamber temperature sensor signals a temperature equal to or higher
than the sterilizing temperature specified for the current program. An
alarm sounds if the temperature sensor registers a value outside the
temperature band, or if the temperature differs by more than the
permitted amount from the chosen sterilizing temperature.
ABC

12
When sterilizing liquids, the temperature is measured with a
temperature sensor in the load. The condition for countdown of
sterilizing time is that both temperature sensors in the chamber and the
sensor in the load indicate the programmed sterilizing temperature.
Post-treatment The purpose of the post-treatment is to normalize the temperature and
moisture content of the goods. All goods except liquids are therefore
exposed for a certain time to a vacuum below 70 mbar (a). After such
post-treatment. textiles may appear to increase in weight by about 1%.
This represents the normal addition of water that occurs during steam
autoclaving process.
Post-treatment of liquids that have been sterilized in open or half-
closed containers consists of a self-cooling period. During this period
the pressure and temperature are lowered very slowly until the
temperature is well below the boiling point of the liquid. This process is
speeded up by applying a slight vacuum to the chamber when its
pressure approaches atmospheric.
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 the order of 0.3 micron (0.0003 mm) in size.
The sterilizer door is kept closed by the door gasket until the pressure in
the chamber is equal to atmospheric pressure.
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 "User-programmable functions" in the TECHNICAL
MANUAL.
NOTE: Liquids must only be processed in sterilizers which
have a program for this type of load.

13
Maintenance program
Leak test Fully automatic process for steam autoclaves
With autoclaves equipped with an analogue pressure transducer the leak
test can easily be automatically performed. The leak test is to be
performed with an empty chamber. The chamber additionally has to
have been warm, for example as a result of a heating program having
been run beforehand.
The checking process has its own program button (see program list)
which starts with the vacuum system evacuating the chamber.
Depending on the equipment of the sterilizer, steam may pass through
before the evacuation. The pump in the vacuum system stops when a
deep vacuum has been created. For a short period of time after this
evacuation a slight rise in the chamber pressure takes place which is not
due to leakage but results from evaporation of condensate and
temperature-volume changes in the recently rarefied residual steam.
It is therefore not possible to establish that an increase in pressure in
the chamber is caused by leakage until conditions in the chamber have
stabilized. It is not until about 10 minutes after the pump has stopped
that the pressure and time start to be measured.
A satisfactory leak test allows for a maximum permissible pressure rise
of 13 mbar / 10 minutes.
With double-ended autoclaves, the loading door opens after a
completed leak test either automatically or manually, depending on how
it has been programmed.
A Normal vacuum 5 min.
B Stabilization of chamber atmosphere 10 min.
C Check time 10 min.
D Pressure stepping max. 13 mbar.
AC
B
D

14
Documentation of the process
A printing pressure and temperature recorder continuously records the
pressure and temperature in the chamber on graph paper. The graph
paper has scales for pressure and temperature.
The picture below is schematic and is not to be used as a
model for evaluating individual process results.
APressure
B Temperature
1Start:
The process is started by selecting a program and pressing the
"Start" button. The pressure curve shows atmospheric
pressure.
2 Pre-treatment:
Theprocess begins withapre-treatmentphase for airexpulsion
and heating of the items.
0 5
1 0
1 5
2 0
2 5
3 0
5 0 1 5 0
º C
1 0 0
- 1 01234
B a r
A
B
1
1
2
2
3
3
4
4
5
5
6
6

15
3Sterilizing:
When the sterilizing temperature is reached, the curves level
out.Thestart of thesterilizationtime is indicatedonthedisplay
of the operator’s 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.
5Drying 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 the
chamber reaches atmospheric pressure, the door gasket (which
was pressed against the door by steam pressure during the
process) is drawn in and the door can be opened.

16