Miele G 7825 Manual
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Operating instructions Washer-disinfector G 7825 / G 7826 To avoid the risk of accidents or damage to the machine it is essentialto read these instructions before it is installed, commissioned and used for the first time.M.-Nr. 07 776 760en - GB, AU, NZ
Warning and safety instructions.....................................4 Correct application...............................................4 Symbols on the appliance.........................................8 Disposing of your old machine......................................8 Intended Use.....................................................9 Guide to the machine.............................................11 Controls.........................................................14 Automatic mobile unit recognition (Optional)..........................16 Mobile unit coding.................................................17 Setting mobile unit coding........................................18 Areas of application...............................................20 Protein test.......................................................20 Loading the machine...............................................21 Surgical instruments (OP)...........................................22 Ophthalmology...................................................23 Anaesthetic instruments (AN)........................................24 Baby bottles (BC).................................................25 Operating theatre shoes (OS)........................................27 Laboratory glassware (LG)..........................................28 Transfer trolley for loading and unloading the machine....................29 Chemical processes and technology.................................31 Dispensing liquid chemical agents..................................36 Preparing the DOS dispensers.......................................37 Fill the containers with the relevant agent............................37 Venting the dispensing system.......................................39 Dispensing system maintenance......................................39 External Dispensing systems.........................................39 Operation.......................................................40 Master switch.....................................................40 Switching on.....................................................40 Door lock........................................................40 To open the door..................................................40 To close the door..................................................40 Operating levels...................................................41 Starting a programme..............................................42 Programme sequence..............................................43 Switching off.....................................................44 Contents 2
Cancelling a programme............................................44 Interrupting a programme...........................................45 Data transfer.....................................................46 Maintenance.....................................................47 Periodic checks...................................................47 Process validation.................................................48 Routine checks...................................................48 Cleaning the filters in the wash cabinet.................................49 Cleaning the fine filter............................................49 Cleaning the flat filter............................................49 Cleaning the filters for the circulation pump...........................50 Cleaning the spray arms............................................51 Cleaning the control panel...........................................52 Cleaning the front of the machine.....................................52 Cleaning the wash cabinet..........................................52 Cleaning the door seals.............................................52 Mobile units, modules and inserts.....................................53 Printer (optional)..................................................54 Renewing the paper roll..........................................54 Renewing the colour cassette.....................................54 After sales service................................................55 Converting the type of heating......................................56 Converting from steam to electric heating or from electric to steam........56 Electrical connection.............................................57 Plumbing........................................................58 Technical data...................................................59 Optional extras...................................................60 Special features - OXIVARIO........................................61 Description of the machine..........................................61 Areas of application.............................................61 Warning and Safety instructions......................................62 Connecting the H 2O2solution container................................62 Disposal of your old machine.......................................63 Contents 3
This machine complies with all relevant local and national safety requirements. Please note that incorrect use can lead to personal injury and damage to property. To avoid the risk of accidents and damage to the machine, please read these instructions carefully before starting to use it. Keep these instructions in a safe place for reference, and pass them on to any future user. Correct application This washer-disinfector is designed for use with the applications described in these Operating Instructions only. Alterations or conversions to the machine, or using it for purposes other than those for which it was designed, are not permitted and could be dangerous. This machine must only be used for cleaning and disinfecting instruments, medical devices and laboratory equipment if the manufacturer has stated that they are suitable for machine processing. Manufacturer's cleaning and maintenance instructions for instruments etc. must also be observed. Miele cannot be held liable for damage caused by improper or incorrect use or operation of the machine. This machine is intended for indoor use only. This machine is not designed for use in mobile installations unless a risk assessment of the installation has been carried out by a suitably qualified engineer. Please pay attention to the following notes to avoid injury and damage. This machine should be commissioned and then maintained by a Miele authorised and trained service technician only. A Miele service contract is recommended to ensure compliance with GLP Guidelines and the Medical Devices Directive. Unauthorised repairs could be dangerous, for which the manufacturer cannot be held liable. Do not install the machine in an area where there is any danger of explosion or of freezing conditions. The electrical safety of this machine can only be guaranteed if connected to a correctly installed earthing system on site. It is most important that this basic safety requirement is present and regularly tested, and where there is any doubt the on-site wiring system should be inspected by a qualified electrician. The manufacturer cannot be held liable for damage or injury caused by the lack of or inadequacy of an effective earthing system (e.g. electric shock). A damaged or leaking machine could be dangerous and compromise your safety. Disconnect the machine from the mains immediately and call the Miele Service Department. Warning and safety instructions 4
Personnel operating the appliance should be trained regularly. Untrained personnel must not be allowed access to the machine or its controls. Take care when handling chemical agents such as cleaning agent, neutralising agent, rinsing agent etc. These may contain irritant or corrosive ingredients. Please follow the manufacturer's safety instructions. Wear protective gloves and goggles. With all chemical agents, the manufacturer's safety instructions and safety data sheets must be observed. The machine is designed for operation with water and recommended additive chemical agents only. Organic solvents and flammable liquid agents must not be used in this machine. These could cause an explosion, damage rubber and plastic components in the machine, and cause liquids to leak out of the machine. The water in the cabinet must not be used as drinking water. Be careful when sorting items with sharp pointed ends and positioning them in the machine that you do not hurt yourself or create a danger for others. Sharp knives etc. should be placed in baskets with the pointed ends facing downwards. When using this machine in the higher temperature ranges, be especially careful not to scald or burn yourself or come into contact with irritant substances when opening the door. Where disinfecting agents are used there is a danger of inhaling toxic vapours. Where there is a risk of toxic or chemical substances occuring in the suds solution (e.g. aldehyde in the disinfecting agent), it is essential to regularly check door seals and make sure that the steam condensor is functioning correctly. Opening the machine door during a programme interruption carries particular risks in such circumstances. Should personnel accidentally come into contact with toxic vapours or chemical agents, follow the emergency instructions given in the manufacturer's safety data sheets. Mobile units, modules, inserts and the load must be allowed to cool down before they are unloaded. Any water remaining in containers could still be very hot. Empty them into the wash cabinet before taking them out. After using the hot air drying unit, open the door to allow the everything in the cabinet from the load itself to the mobile units, modules and inserts to cool down. Do not touch the heating elements (under the wide area filter) during or directly after the end of a programme, you could burn yourself. They remain hot for some time after the end of the programme. Warning and safety instructions 5
If the boiler has been programmed to "BOILER READY", be particularly careful of hot water and steam when opening the door. Danger of burning or scalding. The inlet to the wash cabinet is located, as viewed from the unclean side, underneath the basket runner on the left hand side. Steam heating is permissible up to a pressure of 1000 kPa (10 bar). This corresponds to a water steam temperature of 179°C. Never clean the machine or near vicinity with a water hose or a high pressure hose. The machine must be disconnected from the mains electricity supply before any maintenance or repair work is carried out. Do not reconnect it until the maintenance or repair work has been successfully completed. The following points should be observed to assist in maintaining quality standards for processing medical devices and sensitive laboratory glassware, and to avoid injury to patients or damage to equipment. If the machine is being used for disinfection in accordance with official regulations on the control of epidemics, the steam condenser and its connections to and from the wash cabinet must be cleaned and disinfected whenever any repairs are carried out or parts replaced. If it is necessary to interrupt a programme in exceptional circumstances, this may only be done by authorised personnel. The standard of cleaning and disinfection in the disinfection programmes must be routinely confirmed by the user. The process should be validated on a regular basis, and checked against documented control results.Chemical disinfection procedures should also be validated usingchemicalor bio indicators. For thermal disinfection, use temperatures and temperature holding times to achieve the required infection prophylaxis in accordance with current health and safety regulations. Disinfection programmes which use a chemical disinfecting agent at moderate temperatures such as 65 °C or lower are not recognised by §18 IfSG for disinfection. They should only be used for items which cannot withstand the higher temperatures used by thermal disinfection. The range of effective disinfection is based on claims made by the producer of the disinfecting agent. Their instructions on handling, use and effectiveness must be observed. The use ofchemical disinfection procedures is the responsibility of the operator. Theatre (OP) shoes should only be cleaned and disinfected in a machine installed specifically for this purpose. Warning and safety instructions 6
Only use chemical agents formulated for special processes and approved by Miele for use with this machine. Use of unsuitable agents could adversely affect the components of the machine. In the event of any damage or material deterioration please contact your Miele application specialist. Pre-treatments with cleaning or disinfecting agents can create foam, as can certain types of soiling and chemical agents. Foam can have an adverse effect on the disinfection and cleaning result. Foam must not be able to escape from the wash cabinet. It would hinder the correct functioning of the machine. Check the process used regularly to monitor foaming levels. To avoid the risk of damage to the machine and any accessories used with it caused by chemical agents, soiling and any reaction between the two please read the notes in "Chemical Processes and Technology". Where a chemical agent is recommended on technical application grounds (e.g. a cleaning agent), this does not imply that the manufacturer of the machine accepts liability for the effect of the chemical on the items being cleaned. Please be aware that changes in formulation, storage conditions etc. which may not be publicised by the chemical manufacturer, can have a negative effect on the cleaning result. When using cleaning agents and specialised products it is essential that the manufacturer's instructions are followed. Chemicals must only be used for the purpose they are designed for and in the situation specified, to the exclusion of other chemicals, to avoid such dangers as chemical reactions and material damage. In critical applications where very stringent requirements have to be met, it is strongly recommended that all the relevant factors for the process, such as chemical agents, water quality etc. are discussed with the Miele Application Technology specialists. If cleaning and rinsing results are subject to particularly stringent requirements (e.g. chemical analysis, specialised industrial processes etc.), a regular quality control test must be carried out by the user to ensure that the required standards of cleanliness are being achieved. Mobile units, modules and inserts should only be used for the purpose they are designed for. Hollow instruments must be thoroughly cleaned, internally and externally. Empty any containers or utensils before arranging them in the machine. Do not allow any remains of acids or solvents, and in particular hydrochloric acid or chloride solutions, to get into the wash cabinet. Similarly avoid any materials with a corrosive effect. The presence in compounds of any solvents should be minimal (especially those in hazard class A1). Warning and safety instructions 7
Ensure that solutions or steam containing hydrochloric acid do not come into contact with the steel outer casing of the machine, to avoid any corrosion damage. After carrying out any work on the mains water system, the water supply system to the washer-disinfector must be vented. Otherwise, the components in the machine may become damaged. Please follow the advice on installation in these instructions and the separate Installation Instructions. Using accessories Only use genuine Miele original accessories with this machine. Consult Miele on the type and application of such equipment. Only use Miele mobile units, modules and inserts in this machine. Using accessories made by other manufacturers, or making modifications to Miele accessories, can result in unsatisfactory cleaning and disinfecting results, for which Miele cannot be held liable. Any resultant damage would also invalidate the machine guarantee. Only use chemical agents which have been approved by their manufacturer for use in the application you are using. The chemical agent manufacturer is responsible for any negative influences on the material the load is made from and for any damage they may cause to the machine.Symbols on the appliance Warning: Observe the operating instructions. Warning: Danger of electric shock. Disposing of your old machine Please note that the machine may have contamination from blood or other bodily fluids in it and must be decontaminated before disposal. For environmental and safety reasons ensure the machine is completely drained of any residual water, chemical residues and cleaning agent. Observe safety regulations and wear safety goggles and gloves. Make the door lock inoperative, and block or disable the door in such a way that children cannot accidentally shut themselves in the cabinet. Then make appropriate arrangements for the safe disposal of the appliance. For tank system machines ensure that any water is emptied out of the tank before it is moved. The manufacturer cannot be held liable for damage caused by non-compliance with these Warning and Safety instructions. Warning and safety instructions 8
This washer-disinfector can be used to clean, rinse, disinfect (thermally and chemically) and dry a wide range of reusable medical devices and laboratory equipment. Follow the manufacturer's instructions (according to EN ISO 17664) on how to process their items by machine. Examples of application areas: –surgical instruments, –minimally invasive surgical instruments, – anaesthetic and intensive care instruments, – baby bottles and teats, – maintenance and waste containers, – operating theatre shoes, or – laboratory equipment used in research and development, – laboratory equipment used in areas of analysis and specimen taking, – laboratory equipment used in micro-biology and biotechnology. The type of laboratory equipment which can be processed ranges from evaporating dishes to centrifugal test tubes.Processing medical devices and laboratory equipment by machine achieves reproducible results, and should be used in preference to processing them by hand. Where disinfection is required for the protection of staff and/or patients, a thermal disinfection programme, e.g. the DESIN vario TD programme, should be selected. The parameters for thermal disinfection according to EN ISO 15883-1 (A 0concept) vary depending on the disinfection standard required. They are 80 °C (+ 5 °C, - 0 °C) with a 10 min holding time (A 0600) or 90 °C (+ 5 °C, - 0 °C) with a 5 min holding time (A 03000). An A0value of 3000 is suitable for deactivating the HBV virus. National health and safety regulations regarding disinfection must also be observed. The cleaning programme as well as any chemical agents must be chosen according to the type of soiling and load being processed. The agents used for processing the products should be selected to suit the level of cleaning required as well as the method of analysis used. Intended Use 9
The cleaning result must ensure that the instruments can be disinfected correctly, that no residues are left behind, that subsequent sterilisation can be carried out and that the instruments can be used again safely. Medical devices are best processed using the DESIN vario TD programme, or the OXIVARIO programme where applicable. The use of a suitable carrier (mobile unit, module, insert etc.) is important to ensure the adequate cleaning of the load. Examples are given in the section "Areas of application". The washer-disinfector is programmed to carry out the final rinse with mains water or with processed water of a quality to suit the application (e.g. aqua destillata, purified water, de-ionised water, demineralised water). The water quality is of particular importance for applications requiring analytically clean laboratory glassware. This machine complies with EN ISO 15883 for validation purposes. Intended Use 10