GE 6610 AC-1
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 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: +46 (0)35 549 52
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
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.
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.
Symbols on the unit
Hot surface
This symbol gives warning of a hot surface. |
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
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INSTALLATION
This pre-installation instruction covers the information needed to prepare the installation site, before delivery of the unit.
With the delivery of the machine a specific installation 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, wall openings, 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.
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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: either the front plates are designed to lie outside and overlap 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 transporting a packed or not packed sterilizer thereby avoiding serious accidents.
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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.
Please note that those articles are adapted for each sterilizer. When unpacking more than one sterilizer the articles are not to be interchanged.
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.
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Connection
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.
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.
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.
Electrical
Before welding on or near the sterilizer, ALL plug-in leads must disconnected from ALL the PCBs of the control system.
Components in the control system of the 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%.
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• Check that all terminal screws are tight..
General:Connect the equipment through a nearby multipole 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.
•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 E 110 and 230 V. The signal cable is connected to a multipole socket marked E 110.
•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 to the directive. The public power distribution system
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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 their own individual multi-pole, lockable, safety-marked switches. A switch of this description must always be installed close to the motor.
•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.
Running the shaft seal dry could destroy it in just a few seconds.
•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 is recommended that the three-phase supply should be protected by an earth leakage circuit breaker with a 300 mA trip current.
ESD (Electrostatic discharge)
ESD damage in installation and servicing may destroy the electronic equipment. Read the instructions below BEFORE starting work.
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 people are imperceptibly charged by friction in the air or between shoes and
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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 performance is not maintained. The circuits may even appear to be undamaged 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 testing 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 distributor 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 manufacturer'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 in accordance 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.
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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.
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.
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.
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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
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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:
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|
|
3 |
|
|
|
|
|
|
|
H > 300 mm |
|
|
|
|
7 |
1 |
Main supply line |
2 |
Shut-off valve |
|
3 |
Filter |
|
4 |
Non-return valve |
5 |
Pressure gauge, |
6 |
Reverse siphon protection |
|
|
including water |
7 |
Connection to sterilizer |
|
|
pockets and |
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||
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|
|
|
|
isolating valve
•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
16
conditions can be connected to pipe systems with a pressure as low as 1.0 bar(e), equivalent to 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 to 350 to 600 kpa(e) or 50 to 90 psig. Note that the pressure in the return line must normally be at least 1.0 bar lower, 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.
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!
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 etc must not occur, since the steam comes into physical contact with the goods to be sterilized. These impurities may also block steam traps and chokes.
17
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 microorganisms 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 concentrations exceeding the values given in mg/kg condensate in the table below.
Evaporation residues 1.0 mg/l (ppm), of which:
Silicon in the form of SiO2 |
0.01 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 S/cm [at 20 °C (68°F)]
Suitable hardness ≤ 0.1 dH (1.8 ppm)
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
18
(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
ASee the document “Technical Data” for correct information about steam pressure.
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.
BPermitted pressure variations max ± 0.1 bar (equivalent to ±10.0 kPa or ± 1.5 psi).
Moisture content
Sterilizers 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 not superheated either. Superheating of the steam is highly undesirable in connection with sterilization because it does not contribute the humidification necessary to kill microorganisms.
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.
Steam pressure |
Highest design gas velocity |
|
|
19
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] |
|
|
|
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.
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.
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.
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.
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.
20
9.Branch pipes should be connected to the top of a horizontal main pipe.
10.A steam sampling point with shutoff valve should be provided between the reducing valve and the sterilizer so that the quality of the steam can be checked. The sampling point can also be used for blow-down in preparation for work that requires the steam system to be depressurized.
11.Because it is intended to be used daily, the shut off valve should be easy to operate, for instance a remote controlled ball valve.
12.Insulate steam pipes up to the sterilizer steam connection.
21
An arrangement as shown below normally satisfies the requirements for dewatering, filtration and monitoring facilities when supplying a sterilizer with steam from a main steam supply line.
Feed line in the ceiling (bilder skall ändras 12 t.h. om 4)
Supply line in floor or in the storey below (ändr)
1 |
High-pressure line |
8 |
Vent |
2 |
Labyrinth diverter / separator |
9 |
Ball valve |
3 |
Shut-off valve |
10 |
Steam trap |
4 |
Filter |
11 |
Remote-controlled valve |
5 |
Reducing valve |
12 |
Check valve |
6 |
Safety valve |
13 |
Sterilizer |
7 |
Pressure gauge |
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22
Compressed air quality
Instrument air
To ensure long life and reliable operation, the pneumatic components of the equipment must be connected to a compressed air network that supplies dry air with a low content of particles and oil.
Modern compressed air components are lubricated for life, so there is no need for oil to be added to the instrument air. The air must obviously not contain any solvents or abrasive or corrosive foreign substances that may damage the pneumatic components.
According to international standards, air quality is divided into classes.
ISO 8573-1 quality classes
Quality |
Content of contaminants |
Dewpoint |
Oil |
|
class |
Size and max conc. |
|
content |
|
|
|
|
|
|
|
µm |
mg/m3 |
°C |
mg/m3 |
|
(µInch) |
(ppm) |
(°F) |
(ppm) |
|
|
|
|
|
1 |
0,1 |
0,1 |
-70 |
0,01 |
|
(4) |
(84) |
(-94) |
(8,4) |
|
|
|
|
|
2 |
1 |
1 |
-40 |
0,1 |
|
(39) |
(838) |
(-40) |
(84) |
|
|
|
|
|
3 |
5 |
5 |
-20 |
1,0 |
|
(197) |
(4190) |
(-4) |
(838) |
|
|
|
|
|
4 |
15 |
8 |
+3 |
5,0 |
|
(591) |
(6704) |
(+37) |
(4190) |
|
|
|
|
|
5 |
40 |
10 |
+7 |
25 |
|
(1600) |
(8380) |
(+45) |
(20950) |
|
|
|
|
|
6 |
- |
- |
+10 |
- |
|
|
|
(+50) |
|
|
|
|
|
|
Where the equipment is connected to a common supply of process air and instrument air, the levels recommended below may be unacceptable for process air from a hygienic point of view.
Getinge recommends instrument air in the following classes:
•Contaminants content Class 3 or better.
•Dew point Class 4 or better.
23
• Oil content Class 3 or better.
Air connection
Instrument air only
Some equipment in its basic version has only instrument air. Refer to the practical arrangements below. Any non-return valves, filters, etc. are supplied by the purchaser, unless the contract states otherwise.
Common supply
If the user’s requirements for air quality and the compressed air network can meet the peak loading of the equipment without the pressure dropping below 6 bar(g) / 600 kPa(g) / 85 psig, process air and instrument air can be connected to the same compressed air network. A check valve and sterile air filter, if required, should be supplied by the customer unless otherwise stated in the contract. See “Technical data” for details of peak consumption, etc.
Separate supply
Some equipment with a high peak process air loading is intended to be supplied separately with process air and instrument air. The equipment may not operate properly and may be unsafe if the pressure in the instrument air supply falls because of high process air consumption. Any check valves, filters, etc. must be supplied by the customer unless the contract states otherwise. See “Technical data” for details of peak consumption, pressure, etc.
Practical arrangements
Connect the air connections of the equipment via a shutoff valve to a compressed air network with a pressure of at least 6 bar(g) / 600 kPa(g) / 85 psig and no more than 8 bar(g) / 800 kPa(g) / 115 psig. See also the
24
document “Technical data”. Where information is contradictory, “Technical data” always takes precedence.
1 |
|
|
4 |
2 |
5 |
|
3 |
1 |
Main supply line |
2 |
Shut-off valve |
3 |
Filter |
4 |
Pressure gauge |
Drain
Waste pipes coming from different parts of the equipment must not be combined. They must be piped separately to the floor drain without restriction or back-pressure.
Comply with local regulations relating to waste water (addition of formalin, temperature restrictions, etc.).
•Run the drain pipe(s) with a fall towards the floor drain, where it/they must terminate at a distance of at least two pipe diameters above the highest water level of the water trap, but at least 20 mm (1”) above the water level (dimension A). Pipes less than 1.5 m (5 ft) long require only a minimal fall.
A
•Design the waste pipes for short duration temperatures of about 100oC (212°F)..
Plastic waste pipes should be avoided, as a loss of cooling medium may result in the outlet being exposed to waste water at 100°C (212°F) for a long time.
25
•The capacity of the waste water system must comply with current regulations. The technical data of the equipment states starting values for the calculation of standard flow in hospital and industrial environments. These calculations must be made in accordance with national regulations. Normally, after calculation of the design flow rate, the system capacity must be increased by an additional 50 %.
•The size and number of floor drains must match the size and number of the connections on the equipment; see Technical data. The floor drain opening should be at least 200 mm (8”).
Outlet from safety valve
The equipment and/or its supply lines are fitted with one or more safety valves. Safety valves on equipment with a small opening are fitted with outlet pipes which carry the blown-off steam or air to a safe position in the service area.
Safety valve outlets 50 mm (2”) and larger are normally not fitted with outlet pipes at the factory.
We always recommend, where circumstances allow, that the oulet pipes are re-routed so they they end at a safe place outside the building. In some countries this is a requirement of the pressure vessel authority.
The reason for this is that, in most cases, it is safer to arrange for the steam/air to be discharged outside the service area because of the large volume ejected. If this cannot be done, the safety valve must be fitted with a pipe to carry the steam/air to a safe place. The responsible authority must approve the choice of outlet location.
Pipework connected to the safety valve:
•must have at least the same size of opening as the safety valve
•must NOT contain shut-off valves or other throttling devices
•must be designed to prevent the formation of water pockets or, if this is not possible, must be fitted with drain pipes to carry away trapped water
Ventilation
All types of equipment
On the basis of the values for heat dissipation given in the technical data, the ambient temperature around the equipment must be regulated to 15 to 35oC (60 to 95°F) by means of a suitable ventilation system. If possible, relative humidity should not exceed 85 %.
These requirements apply not only to the service area of the equipment but also to the operator areas.
26
All sterilizers
Bear in mind the heat contribution of the load when unloading and when storing after the process.
The load contributes a significant amount of heat to the operator area when the load is unloaded on completion of the process. This heat emission is not stated in the technical specification.
Sterilizers with a vertically-operating door:
Each sterilizer door is fitted with a ventilation stub, which must be connected to the ventilation system. This provides an efficient barrier to prevent excessive surplus moisture and heat finding their way into the operator area.
Inspection by authorities
The user of the equipment must, upon installation of the unit, inform the appropriate authorities that this has been done and also comply with local restrictions governing the connection of water, drainage and ventilation. There are often local restrictions on connection to the drinkingwater mains, on how wastewater is to be treated and how ventilation is to be arranged. This is particularly important when installing sterilizers for formalin sterilization or ethylene oxide sterilization as limit values for emissions may have to be complied with.
The owner of the equipment must find out whether a pressure vessel authority inspection must be carried out prior to use.
Response for pressure vessel and safety valves
Pressure vessels subjected to cyclic loads must according to pressure vessel regulations be inspected periodically.
The end-user is responsable to arrange inspections of pressure vessels and checks of safety valves in accordance with requirements from notified bodies in each country.
All equipment with safety valves: If the equipment is provided with one or more safety valves, a description of a check is to be found in the section Check of safety valve in the chapter GENERAL ADVICE.
All equipment with bursting disc: A description for assembly of bursting discs is to be found at Assembly of bursting disc in chapter COMPONENS.
27
Pressure vessel with door(s): If the equipment is provided with pressure vessel doors, a description of a safety check is to be found in the DOOR chapter.
Only for equipment according to the European pressure vessel directive: The first inspection must be carried out at the latest upon a number of cycles given by the manufacturer on the pressure vessel EEC declaration of conformity. Further inspections is stated by the notified body, normally at the first inspection.
Functional check-up prior to use
•This function check must be carried out by a skilled technician. See chapter FUNCTIONAL CHECK for further information.
•For sterilizers that are to be validated under European Standards, the function check must be based on instructions according to EN554.
The user should set up a routine for continuous tests of the equipment.
28
FUNCTION CHECK
Before use
Read all the documentation and check that all supply media are correctly connected to the connection points.
•Check that the guidelines of the installation instructions about the connection of supply media are followed: electric power, water, compressed air, steam, etc.
•Check also that the guidelines for waste and ventilation have been met.
•Check that the operating instructions are displayed at the unit.
•Carry out any customisations of the unit (where applicable). See the section headed “Functions which can be programmed by the user” in the chapter on ADVICE AND INSTRUCTIONS.
•Check that all the connecting screws belonging to electric cables are sufficiently tightened. Pay particular attention to power wiring.
•Open the valves for all supply media.
•Check that the water tank level is about 13 mm (1/2”) below the spill way. Adjust if necessary on the float valve.
•Check that the feed water enters at least 20 mm above the overflow level.
•When the feedwater tank is full of water, check the direction of rotation of the vacuum pump by briefly pressing the contactor. The direction of rotation of the pump must agree with the arrow on the pump housing. To reverse the direction of rotation, follow the instructions under Electrical in the chapter INSTALLATION.
•If the vacuum pump does not draw sealing water immediately when it starts, fill the feedwater tank to the brim by closing off the overflow and holding down the float. It may also be necessary to briefly open the pump throttle valve fully, to restore it to the correct position when the pump gas started to draw water.
Do not let the pump run dry for more than a few seconds.
29
•If the vacuum pump has jammed, pull off the pump impeller according to the instructions in the COMPONENTS chapter of this manual.
•Perform all safety checks as described in the GENERAL ADVICE and The Door chapters.
•Check and, if necessary, adjust the supply of sealing water and leak air to the vacuum pump. See under the heading “ECO-water conservation system” in the MAINTENANCE chapter for adjustment of the sealing water, and under “Vacuum pump” in the COMPONENTS chapter for adjustment of the leak air.
•Check the fans for correct direction of rotation. When seen from inside the chamber, they should rotate anti-clockwise. To reverse the direction of rotation, follow the instructions under Electrical in the chapter INSTALLATION.
•Check that condensate drips down into the collecting cups at the fan seals when the sterilizer is running. The rate should be a at least five drops per second (200 ml/minute).
•Check that the fan seal does not leak condensate through the overflow pipe.
•Do a leakage check on the installation and the sterilizer. Covered-in equipment and cabinet models must be checked with the cladding plates removed.
•Run all processes while checking pressure, temperature, times and the operation of the indicator lamps. Set points will be found in the phase list. File the test run printouts.
Note that the basic version of some equipment, and apparatus connected to higher-level systems, may not have special provision for process printout.
30
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