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
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 +46(0) 35 54952
1
2
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
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.
Instructions
This symbol highlights instructions that are important for avoiding damage to the unit and/or load, among other things.
Advice
This symbol indicates important advice and hints that make it easier to work with the unit.
SAFETY - 3
Symbols on the unit
Hot surface
This symbol warns of a hot surface.
Electrical danger
This symbol warns of an electrical danger.
Other dangers
This symbol warns of other dangers.
4 - SAFETY
Reporting an accident or incident
Use this information when reporting incidents and accidents involving the unit.
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
305 05 GETINGE Sweden
Fax: +46 (0)35 549 52
SAFETY - 5
6 - SAFETY
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.
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.
INTRODUCTION - 7
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 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 surface 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 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 welldimensioned thermal insulation around the chamber mean that the autoclave affects the surroundings to an insignificant extent and is therefore easy to position.
HS 66-autoclaves have to be supplied with electricity, cold water, compressed air and steam. When steam is supplied from a central steam-pro- ducing plant, its distribution system is required to be correctly pressurereduced, 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
8 - INTRODUCTION
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
Cladding and front panels must prevent access to the 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.
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.
INTRODUCTION - 9
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. 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. 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
10 - INTRODUCTION
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. Permitted supply media pressures are stated in “Utility data”.
Safety valves
Safety valves limit the system pressure, providing the last line of protection to prevent the design pressure of the vessel from being exceeded. Safety valves are required to be inspected at prescribed intervals.
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.
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 changeover 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 sterilizer 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 sterilisation purposes.
INTRODUCTION - 11
A feedwater pump supplies the steam generator with water from an integral 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 button 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 contacts 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 MANUAL.
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 conductivity above 2 μS/cm.
12 - INTRODUCTION
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 is required and the sensitivity setting must be 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 contacts 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.
INTRODUCTION - 13
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 regulations.
The button is also used when filling an empty steam generator with water. See the Function check chapter in the INSTALLATION MANUAL.
“Test level limiter” button
This button is provides a quick test of the operation of the boil-dry protection. 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 instructions 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.
14 - INTRODUCTION
THE PROCESS
The steam sterilizing process
The universal steam autoclaving process can be divided into three main phases:
APre-treatment
BSterilizing
CPost-treatment
A |
B |
C |
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.
THE PROCESS - 15
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.
NOTE: Liquids must only be processed in sterilizers which have a program for this type of load.
Pressure equalization from vacuum takes place by admitting atmospheric air into the chamber via a filter that prevents bacteria from entering the chamber. The efficiency of the filter is 99.998% for particles of 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.
16 - THE PROCESS
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.
ANormal vacuum 5 min.
BStabilization of chamber atmosphere 10 min.
CCheck time 10 min.
DPressure stepping max. 13 mbar.
Documentation of the process
A panel printer prints out data logged during the process.
THE PROCESS - 17
See Components in the TECHNICAL MANUAL for printer settings and maintenance.
The system stores the last process so that an “emergency printout” can be produced afterwards if there is a problem with transmission of the printout or with the printer itself.
If the system is fitted with a SUPERVISOR, the printer is connected to that. Otherwise it is normally connected to the control system. SUPERVISOR is an independent measuring system that records the process data of the sterilizer. See also Control unit in the TECHNICAL MANUAL for further information.
The illustration below is schematic and must not be used as a template for evaluating individual process results.
13:47 |
29 06 04 |
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SIGNATURE |
……… |
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6 |
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.. |
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5 |
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PROCESS OK |
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00:24:58 |
71.2 |
132.5 |
85.2 |
0.995 |
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PROCESS COMPLETE |
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00:23:39 |
75.5 |
132.5 |
85.2 |
0.039 |
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EQUALIZATION |
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00:18:35 |
51.1 |
132.2 |
88.6 |
0.096 |
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00:16:14 |
134.9 |
135.4 |
134.8 |
3.076 |
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DRYING |
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HIGHEST TEMP |
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135.2C |
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LOWEST TEMP |
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134.9C |
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134.9C |
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00:16:08 |
135.0 |
135.5 |
134.9 |
3.094 |
4 |
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POST-TREATMENT |
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00:12:07 |
134.1 |
134.3 |
134.0 |
3.039 |
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STERILIZING |
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00:09:10 |
106.5 |
132.6 |
103.6 |
1.088 |
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18 - THE PROCESS
HEATING |
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00:08:50 |
115.8 |
132.5 |
115.6 |
1.880 |
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00:08:33 |
107.8 |
132.6 |
104.3 |
1.107 |
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POS PULSING |
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00:08:14 |
115.9 |
132.5 |
115.7 |
1.876 |
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00:07:57 |
107.2 |
132.6 |
103.1 |
1.103 |
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POS PULSING |
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00:07:38 |
116.0 |
132.6 |
115.7 |
1.880 |
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00:07:21 |
106.0 |
132.6 |
100.1 |
1.119 |
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POS PULSING |
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00:07:02 |
116.1 |
132.2 |
114.9 |
1.877 |
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00:06:44 |
104.5 |
132.4 |
77.2 |
1.090 |
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POS PULSING |
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00:06:24 |
116.6 |
132.3 |
87.4 |
1.875 |
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00:05:52 |
92.0 |
132.5 |
34.0 |
0.835 |
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POS PULSING |
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00:05:32 |
78.4 |
132.7 |
33.7 |
0.065 |
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00:04:22 |
91.3 |
132.5 |
33.9 |
0.836 |
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NEG PULSING |
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00:04:01 |
75.1 |
132.5 |
33.4 |
0.066 |
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00:02:54 |
81.4 |
132.5 |
33.7 |
0.849 |
4 |
NEG PULSING |
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00:02:37 |
81.9 |
132.6 |
33.4 |
0.099 |
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00:00:15 |
46.6 |
132.6 |
33.4 |
0.997 |
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NEG PULSING |
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00:00:00 |
46.5 |
132.5 |
33.4 |
0.997 |
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START |
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PROG. TIME |
AI00 |
AI01 |
AI02 |
AI03 |
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PROGRAM: P1 POROUS LOAD 134 |
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AI03 |
CHAMBER PRESSURE |
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AI02 |
AIR DETECTOR |
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THE PROCESS - 19
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