Getinge HS 6613 ER-2 Product information sheet

HS 6613 ER-2
UNITED DOCTORS HOSPITAL
2530290-090-01
Original User Manual

TABLE OF CONTENTS
PREFACE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Attention symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Reporting an accident or incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
HS 66. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Overview of safety devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Built-in electrical steam generator. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
THE PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
The steam sterilizing process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Maintenance program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Documentation of the process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
INSTRUMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
OPERATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Program start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Alarms - Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
General advice when using the sterilizer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Weekly cleaning - Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Approved consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
OPERATION INSTRUCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Daily preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
CONTROL UNIT PACS 3500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Control panel type Avanti . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Operator menu Avanti. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
PROGRAM COMBINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67

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.
Manufacturer address:
Getinge Sterilization AB
Ekebergsvägen 26
305 75 Getinge
Sweden
Fax [phone]

2

SAFETY - 3
SAFETY
Attention symbols
Some of the warnings, instructions and advice in this manual are so
important that we use the following special symbols to draw attention
to them. The designs and symbols used are:
Warnings
Instructions
Advice
This symbol indicates a warning in the text of the manual.
It warns of a hazard that may lead to 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” in the Introduction
chapter in the USER MANUAL or in the Maintenance
chapter 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.

4 - SAFETY
Symbols on the unit
Hot surface
Electrical danger
Other dangers
This symbol warns of a hot surface.
This symbol warns of an electrical danger.
This symbol warns of other dangers.

SAFETY - 5
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 acci-
dents/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 cabi-
net), 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
305 05 GETINGE
Sweden
Fax: [phone]
Use this information when reporting incidents and acci-
dents involving the unit.

6 - SAFETY

INTRODUCTION - 7
INTRODUCTION
HS 66
HS 66 is the designation of a series of GETINGE high-pressure auto-
claves 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 func-
tions 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 proc-
ess 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 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 con-
tainers filled with liquids.

8 - INTRODUCTION
European standard EN 285 (Australia/New Zeeland, Standard AS 1410)
specifies the use of fixed programs only. However, the control equip-
ment of HS 66-autoclaves allows the programs to be made variable dur-
ing the time testing is in progress.
As not only the processes but door operation too are controlledautomat-
ically, the step to full automation of the handling of sterile items 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 sur-
face of the chamber is more than half covered by all-welded U-sec-
tions.. 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 insu-
lation has been removed.
A vacuum pump of the water-ring type removes air, steam and conden-
sation 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 auto-
clave affects the surroundings to an insignificant extent and is therefore
easy to position.
HS 66-autoclaves have to be supplied with electricity, cold water, com-
pressed air and steam. When steam is supplied from a central steam-pro-
ducing plant, its distribution system 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 gener-
ator can be installed inside the trim plates on all models. The task of the

INTRODUCTION - 9
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”, “Utility 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.
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.
Cladding and front panelsmust preventaccess to the parts
of the installation that are normally accessible only to
trained personnel.
General access to an installation supplied without clad-
ding, which should normally only be maintained by trained
personnel must be prevented. A convenient way of pre-
venting access is to install the equipment in a lockable
area.

10 - INTRODUCTION
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 stop
In 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. Press-
ing the button triggers an alarm. This alarm stops the door immedi-
ately:
BWhen the door is closed
The current process is aborted and all valves for media to the cham-
ber 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.
Stainless steel surfaces within reach of the operating personnel are insu-
lated 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

INTRODUCTION - 11
undesired flow through the valves in case of power failure. A fail safe
function is achieved.
Pressure vessels
The sterilizer chamber jacket and steam generator are pressure vessels,
designed and built in accordance with standards laid down by official
bodies charged with monitoring this area of safety.
The internal steam supply to the sterilizer is protected against excessive
supply pressure by a safety on the steam generator, the sterilizer or both.
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. Per-
mitted supply media pressures are stated in “Utility data”.
Safety valves
Safety valves limit the system pressure, providing the last line of pro-
tection to prevent the design pressure of the vessel from being exceeded.
Safety valves are required to be inspected at prescribed intervals.
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 tight-
ness of the chamber.
Built-in electrical steam generator
The sterilizer also has a fully-automatic built-in steam generator, with
tubular electric elements as the heat source.
Operation
The heating power is divided among a number of groups of elements.
The elements are controlled by a pressure switch with double changeo-
ver contacts, one for each heater element circuit. One group of contacts
limits the operating pressure of the steam generator. The other controls
reconnection of the power when the minimum pressure is reached.
Pressures higher than those stated on the electrical diagram should not
be set, since the steam will be superheated when admitted to the steri-
lizer chamber. On the other hand, if the operating pressure is allowed to
fall too far, the steam tends to become wet, which is undesirable for ster-
ilisation purposes.

12 - INTRODUCTION
A feedwater pump supplies the steam generator with water from an inte-
gral water tank with air trap. The water level of the steam generator is
sensed by a device which controls the operation of the pump so that the
level is kept almost constant. Boil-dry protection cuts off the supply of
electric power to the elements when the water level is low.
See also “Steam generator settings and controls” under Advice and
instructions in the TECHNICAL MANUAL.
Control switch
The steam generator and sterilizer are controlled by the same switch. On
sterilizers with med double steam systems there is an extra shutoff but-
ton marked Steam generator.
Pressure regulation in power stages
The system prevents wear of the element contacts by switching the
power in and out in two stages at different pressure levels and with a
time offset between switch-on and switch-off for the first stage.
Spark-reduction connection
As well as shortening the life of electrical contacts, sparking at the con-
tacts may also cause interference with nearby electronic equipment.
The anti-spark protection is based on fast-acting auxiliary relays taking
over the load from the slow-breaking contacts of the pressure switch for
operating pressure, so largely eliminated sparking.
Safety valve, steam generator
The mandatory periodic check of the operation of the steam generator
safety valve can be done simply by means of the keyswitch described
below. See also the Maintenance chapter in the TECHNICAL MAN-
UAL.
Keyswitch “Test pressure limiter”
When the key is in the safety valve check position, steam is produced
continuously and regardless of the setting of the operating pressure
switch.
Water level regulation
Version with conductive measurement
The Getinge conductive level system is designed for water with a con-
ductivity above 2 μS/cm.

INTRODUCTION - 13
The task of the level device is to sense and control the water level of the
steam generator. The main components are a sensitive relay and two
electrodes, the ends of which touch the water surface at the upper and
lower fill levels. Contact of the upper electrode with the water stops the
feedwater pump, whilst absence of contact at the lower electrode starts
the pump. A third, lowest, electrode cuts off the electric power supply
to the heating elements when the electrode loses contact with water; see
boil-dry protection below.
The type and sensitivity of the level relays can be adapted to varying
water conductivity. If the feedwater is de-ionised, a high-sensitivity
level relay isrequired and the sensitivity setting mustbe increased as the
conductivity of the water decreases.
The sensitivity of the level relay is automatically adjusted at power up
to match varying conductivity.
The distance between the electrodes is another factor that affects the
overall sensitivity of the level control system.
Version with float
The GETINGE float-based level control system is intended for water
with a conductivity of 0 to 2 μS/cm, but it can also be used for higher
conductivity.
The task of the level device is to sense and control the water level in the
steam generator. The main components are a float with two level con-
tacts and two relays. The level contacts change over at the upper and
lower fill levels. The upper contact stops and starts the feedwater pump,
whilst the lower contact cuts off the electric power supply to the heating
elements; see boil-dry protection below. The purpose of the relays is to
protect the float contacts from harmful currents.
Water-level monitoring
A lamp in the “reset level” button on the steam generator control panel
is lit when the water level is correct. On some models, the water level
can also be read off on a sight glass. The sight glass has two valves
which can be closed to prevent loss of water and steam in the event of
breakage of the sight glass.
Boil-dry protection
If the water filling fails, the boil-dry protection cuts off the electric
power supply after a certain time, when the water level has fallen below
a minimum limit.
Overheat protection
This protection prevents the steam generator from overheating if the
boil-dry protection should fail to operate.

14 - INTRODUCTION
Overfilling protection
The timer relay prevents the steam generator over-filling with feedwater
if the level control system stops working.
“Reset level ” button
If a fault occurs on any of the safety components of the steam generator,
it must be reset manually in accordance with applicable boiler regula-
tions.
The button is also used when filling an empty steam generator with
water. See the Function check chapter in the INSTALLATION MAN-
UAL.
“Test level limiter” button
This button is provides a quick test of the operation of the boil-dry pro-
tection. The test interrupts the level circuit without the need to reduce
the water level.
RCD
Some types of steam generator must be connected to the electric power
supply via a residual current device (RCD). See the Installation instruc-
tions chapter in the INSTALLATION MANUAL.
Safety switch
It must be possible to isolate all electric power supplies to the steam
generator with a safety switch. The safety switch must be lockable in the
OFF position. See also chapter Installation in the INSTALLATION
MANUAL.

THE PROCESS - 15
THE PROCESS
The steam sterilizing process
The universal steam autoclaving process can be divided into three main
phases:
APre-treatment
B Sterilizing
C Post-treatment
Pre-treatment
It has been found that moisture is an essential element in achieving ste-
rility 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 fol-
lowing 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 tem-
perature band, or if the temperature differs by more than the permitted
amount from the chosen sterilizing temperature.
ABC

16 - THE PROCESS
When sterilizing liquids, the temperature is measured with a tempera-
ture 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 pres-
sure 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 atmos-
pheric air into the chamber via a filter that prevents bacteria from enter-
ing 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, packag-
ing 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.