Miele PG 8536 Operating Instructions Manual Download Page 1

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Operating instructions

Washer-disinfector
PG 8536

To avoid the risk of accidents or
damage to the machine it is

essential

to read these instructions

before it is installed, commissioned
and used for the first time.

M.-Nr. 10 317 371

en - GB, AU, NZ

Summary of Contents for PG 8536

Page 1: ...ons Washer disinfector PG 8536 To avoid the risk of accidents or damage to the machine it is essential to read these instructions before it is installed commissioned and used for the first time M Nr 10 317 371 en GB AU NZ ...

Page 2: ...the door 24 Electric door lock 24 To open the door with the emergency release 24 Water softener 25 Setting the water softener 25 Reactivation display 25 Reactivating the water softener 26 Filling the salt container 26 Position the salt container as follows 26 Run the reactivation programme 27 Automatic mobile unit recognition 28 Spray arm monitoring 29 Areas of application 30 Protein test 30 Loadi...

Page 3: ...f the programme 50 Switching off 50 Cancelling a programme 51 Interrupting a programme 52 Process documentation 53 Maintenance 54 Periodic checks 54 Process validation 54 Routine checks 54 Cleaning the filters in the wash cabinet 55 Cleaning the coarse filter 55 Cleaning the coarse flat and micro fine filters 56 Cleaning the spray arms 57 Cleaning the control panel 58 Cleaning the front of the mac...

Page 4: ...nection pressurised ö 60 1000 kPa over pressure 68 Optional AD water connection without pressure 8 5 60 kPa 68 IMPORTANT Australia and New Zealand 69 Drainage 70 Technical data 71 Optional extras 72 Special processes OXIVARIO and ORTHOVARIO 73 Intended use 73 Areas of application 73 Warning and Safety instructions 74 Connecting the H2O2 solution container 74 Disposal of your old machine 75 Content...

Page 5: ...ionary indoor use only Please pay attention to the following notes to avoid injury and damage This washer disinfector 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 Device Directive Unauthorised repairs could be dangerous and jeopordise the personal...

Page 6: ...ing at high temperatures If the door is opened with the emergency release cord there is a danger or burning scalding or chemical burning or if 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 t...

Page 7: ...ust also be validated using chemical or 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 Medical devices should be reprocessed by thermal disinfection Items which are not heat resistant e g operating theatre OP shoes should be cleaned with the CHEM DISIN prog...

Page 8: ...ant factors for the process such as chemical agents water quality etc are discussed with Miele If cleaning and rinsing results are subject to particularly stringent requirements e g chemical analysis a regular quality control test must be carried out by the supervisor to ensure that the required standards of cleanliness are being achieved Mobile units baskets and inserts should only be used for th...

Page 9: ...hine 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...

Page 10: ...achieves reproducible results and should be used in preference to reprocessing them by hand Where disinfection is required for the protection of staff and or patients carry out thermal disinfection using e g the DESIN vario TD programme Except for operating theatre OP shoes which are not heat resistant for which the CHEM DISIN programme should be used The parameters for thermal disinfection accord...

Page 11: ...with EN ISO 15883 for validation purposes User profile Daily operatives Operatives using the machine daily should be familiar with the basic functions of the machine and its loads and trained on a regular basis They require basic knowledge about how to reprocess medical devices by machine Generally they would be using the machine in Operating levels A and C Supervisory level More advanced function...

Page 12: ...st point for validation eSalt reservoir connection point for the water softener fFilter combination gService panel hContainers for dispensing systems DOS 2 and DOS 4 optional iDOS drawer jReservoir for neutralising agent red and liquid cleaning agent blue kDrying unit TA lReset button Description of the machine 12 ...

Page 13: ...off automatically after approximately 10 minutes when the washer disinfector is not in operation Press any button to switch the display back on again Faults occurring during operation will be indicated by a number in the display The fault numbers are listed in the Programming manual Description of the machine 13 ...

Page 14: ...d i e buttons Selector buttons used to move the highlighting in the display change highlighted values scroll call up context menus show user defined operating parameters during the programme hOK button confirm highlighted options or selected values acknowledge error messages acknowledge dialogue messages call up the A0 graph during a programme view the temperature graph during a programme Descript...

Page 15: ...e selector buttons e move the highlighting in the display The OK button is used to confirm a message or setting and also to move to the next menu or to another menu level To select an option use the selector buttons e to highlight it and then confirm your selection with the OK button The display shows a maximum of three options or choices A scroll bar on the right hand side of the display indicate...

Page 16: ... display shows the following the name of the programme the operating level the programme block the water temperature the air temperature in the Drying programme block the estimated programme duration remaining or the programme duration already elapsed any relevant error messages and notes Description of the machine 16 ...

Page 17: ...rt In addition no current fault messages will be displayed in operating level D if applicable Press the e buttons at the same time for at least 3 seconds to call up the context menu The context menu will appear in the display Context menu B Change display language F Change operating level Delay start The e buttons are used to select the options Context menu 17 ...

Page 18: ...s will continue to be printed in this Settings language Select the Change display language option with e and activate your selection with OK The flag J after the words Change display language acts as a guide if a language which you do not understand has already been set If this is the case keep changing the options until the flag J appears Select the language you require and confirm your selection...

Page 19: ...n the operating levels via the context menu To prevent unauthorised access to the settings you will be asked for a code when changing to another operating level You must be signed on as the administrator to be able to change the codes of the various operators or to install new operators The Administrator operator is set by a Miele Service technician Press the e buttons at the same time for at leas...

Page 20: ... Change operating level B 0 F F F Enter code The e buttons alter the values the OK button confirms the values entered and moves on to the next input position The electronics will change to the operating level selected Press C to come out of the context menu Code invalid will appear if you make a wrong entry Acknowledge the fault message with OK The Change operating level process will begin again C...

Page 21: ...Yes for the Activate option Delay start B Activate Yes Delay start To set the Delay start time highlight the Delay start parameter and confirm your selection The menu for entering the start time will appear Delay start B 17 48 Enter time Enter the start time digit by digit and confirm your entry Press the C button repeatedly until Programme overview appears in the display Programme overview B REAC...

Page 22: ...art time Yes No To cancel the programme start time select Yes and confirm your selection The automatic start time for the programme is now cancelled The display will change back to the Programme overview The Delay start function is deactivated If you select No the delay start time for the programme will continue to count down The Delay start function is deactivated automatically at the end of the ...

Page 23: ...ion Select the option and confirm your selection with OK Any faults which are present at the moment will be displayed Use OK to change between the fault messages Press C to come out of the context menu Reactivation This option is only visible in Operating level C when a programme is not running All other procedures in connection with the water softener are described in the section Water softener C...

Page 24: ...y be used when the door cannot be opened normally e g in the event of a power failure Be especially careful when using DESIN programmes read the notes in the Warning and Safety instructions carefully If the door is opened using the emergency release cord there is a danger of burning scalding and chemical burning or if a disinfecting agent has been used inhalation of toxic fumes Do not touch the he...

Page 25: ...chine Where the water hardness level fluctuates e g 1 4 3 1 mmol l 8 17 dH set the water softener to the highest setting 3 1 mmol l 17 dH in this example The built in water softener has settings from 1 dH 60 dH 0 2 10 8 mmol l For future servicing it is useful to make a note of your water hardness level Enter your water hardness level here dH mmol Setting the water softener When the machine is fir...

Page 26: ...ntly filling the salt reservoir with cleaning agent can cause serious damage to the water softener and block the filter insert resulting in a build up of pressure inside the salt container To avoid the risk of injury please excercise caution when removing the salt reservoir as there may be irritant alkaline solutions present Before filling the salt reservoir make sure that you have picked up the r...

Page 27: ... work properly There could be residual salt in the container after reactivation has taken place To use up the remaining salt and to flush out the softener the REACTIVATION process must be repeated Then Switch the washer disinfector off Open the door Carefully unscrew the salt container making sure any water pressure still remaining can depressurise Do not use force If the container will not come o...

Page 28: ...door closed the automatic mobile unit recognition system will select the allocated programme The coding of the mobile units and the allocation of programmes in the electronic control unit are described in the Programming manual for the washer disinfector Make sure that there are no small metallic objects or instrument parts attracted to the magnetic strip in particular to the underside of it Any m...

Page 29: ...itored This does not require a magnetic strip The machine is supplied with spray arm monitoring switched off for the upper basket If upper baskets without spray arms are always used this setting can be left unchanged If upper baskets with and without spray arms are used and spray arm monitoring is active the following question will be asked before starting the programme Basket with one spray arm A...

Page 30: ... the filters clean Remove any coarse soiling and clean them properly if necessary Is the adapter connecting the water supply to the spray arms jets correctly connected Are all chemical containers sufficiently filled At the end of each programme Carry out a visual check of the load for cleanliness Check that all hollow shafted instruments are still securely located on their jets Any hollow instrume...

Page 31: ...e water runs off them freely Tall narrow pieces should be placed in the centre of the baskets This ensures good water coverage Mobile units with an adapter must engage correctly Modules must be correctly connected in the mobile unit The spray arms must not be blocked by items which are too tall or which hang down in their path If in doubt test for free movement by manually rotating the spray arms ...

Page 32: ...justed above and below the middle position by 2 cm Different height items can be reprocessed in this machine depending on the position the top basket is set at and the inserts used in the baskets mobile units The height available in the right hand side of the top basket is limited by the salt reservoir connection point To adjust the top basket Pull out the top basket until a resistance is felt lif...

Page 33: ...ruments and place them in mesh trays so that they are not touching each other Mobile units for surgical instruments are supplied with their own operating instructions When reprocessing narrow lumen instruments e g those used for minimally invasive surgery an intensive internal cleaning result is imperative The Vario TD and OXIVARIO special kit required programmes are the only ones which offer a th...

Page 34: ...ollow instruments e g rinsing and suction hand pieces and cannulae Instruments are secured to the hose connectors in the mobile injector unit using the silicone holders and connectors in the rack The lower level of the mobile injector unit is designed to take E 441 1 inserts or E 142 mesh trays for reprocessing solid instruments Plastic fibre cover nets must not be used in washer disinfectors whic...

Page 35: ...me If the process is not to be followed by sterilisation the load should be dried completely to avoid the development of water borne bacteria A sufficient drying time is therefore absolutely essential Mobile units for anaesthetic instruments are supplied with their own operating instructions Areas of application 35 ...

Page 36: ...s a delay of 4 hours or more before bottles can be washed fill them with water to prevent residues from drying on If the process is not to be followed by sterilisation the load should be dried completely to avoid the development of water borne bacteria A sufficient drying time is therefore absolutely essential Inserts for baby bottles and teats are supplied with their own operating instructions Ar...

Page 37: ...purpose A risk evaluation should be carried out by the user when using other applications in addition to the preparation of OP Theatre shoes in the washer disinfector The following baskets can be used O 167 for theatre shoes up to size 40 O 173 for theatre shoes up to size 41 and U 168 1 for theatre shoes up to size 45 Alternatively insert E 484 can be used in a suitable bottom basket e g U 874 to...

Page 38: ... machine Preparing the load Empty all glassware before loading into the machine paying particular attention to regulations regarding epidemics Ensure that acids and residual solvents especially hydrochloric acid or chlorides cannot get into the wash cabinet Remove all agar residues from Petri dishes Remove blood clots and residues from test tubes etc Remove all stoppers corks labels sealing wax re...

Page 39: ...ASTIC Programme for items with slight to medium heavy soiling which have medium final rinse result requirements for temperature sensitive laboratory equipment e g plastic bottles which can withstand temperatures of at least 55 C for preparation areas suitable for some analysis ORGANIC Programme for items with medium heavy to heavy soiling which have medium final rinse result requirements for remov...

Page 40: ...d rectify it Check the process used regularly to monitor foaming levels See information regarding Chemical agents Soiling and Reaction between chemical agents and soiling Corrosion to stainless steel in the wash cabinet and to accessories can give them a different appearance Rust red marks discolouration black marks discolouration white marks discolouration etched surface Corrosive pitting can lea...

Page 41: ...ommendations Carry out a regular visual check of any accessible elastomers and plastics for damage Hydrogen peroxide can release large quantities of oxygen Only use approved processes such as OXIVARIO or OXIVARIO PLUS The wash temperature must be less than 70 C when using hydrogen peroxide Please contact Miele for advice The following chemical agents can cause large amounts of foam to build up cle...

Page 42: ...ng the ORGANIC programme Please contact Miele for advice Soiling Problem How to resolve it The following substances can damage elastomers hoses and seals and plastics in the washer disinfector oil wax aromatic and unsaturated hydrocarbons emollients cosmetics hygiene and care products such as creams analytical applications Refit the washer disinfector with oil resistant elastomers Depending on usa...

Page 43: ...elect a cleaning programme with at least one short pre rinse in cold or hot water Depending on application use de foaming agents that do not contain silicone oils The following substances cause corrosion to stainless steel in the wash cabinet and on accessories hydrochloric acid other substances containing chlorides such as sodium chloride etc concentrated sulphuric acid chromic acid particles of ...

Page 44: ... application use de foaming agents that do not contain silicone oils Soiling containing high protein levels such as blood can cause a heavy build up of foam when processed with alkaline chemical agents Select a cleaning programme with at least one short pre rinse in cold water Non precious metals such aluminium magnesium and zinc can release hydrogen when processed with very acidic or alkaline che...

Page 45: ...ense up to 105 ml min Up to two further optional dispensing units can be built in Flow rate Media 120 ml min alkaline 20 ml min acidic The reservoirs containing the chemical agents are placed in the top section of the drawer of the washer disinfector Additional optional DOS modules Dispensing system DOS S 20 to dispense acidic media such as neutralising agent It can dispense 20 ml min Dispensing s...

Page 46: ...al tenside cleaning agent It can dispense up to 120 ml min If the ORTHOVARIO process is used chemical disinfecting agents cannot be used in the DOS 4 dispenser Dispensing systems The agents can be filled into 5 l plastic containers which are colour coded for the relevant dispensing system Take great care when handling liquid agents and additives These may contain irritant or corrosive ingredients ...

Page 47: ...or Open the container and fill with the desired chemical agent paying attention to the colour coded labelling Insert the siphon tube into the container and screw on securely observing the colour code Once the storage containers have been filled the relevant message goes out Place the container in the DOS drawer and close the DOS drawer Dispensing liquid chemical agents 47 ...

Page 48: ...o in the display with the appropriate Service programme The level query for dispensing systems which are not being used can be turned off to avoid the error message see Machine functions container query in the Programming manual supplied with the washer disinfector Venting the dispensing system If a dispensing system has been emptied completely it must be vented after the container has been filled...

Page 49: ...l unit To operate it Open the DOS drawer Press the reset button This shuts down the profitronic unit and then restarts it Starting the programme See the Programme charts in the Programming manual supplied with the machine for detailed information and important notes on the standard Miele programmes When reprocessing medical devices any changes made to programmes or dispensing systems must be docum...

Page 50: ...le unit recognition are correctly coded Push the coded mobile unit into the washer disinfector Close the door Press the Start button h The programme will proceed Programme sequence The programme will start automatically as soon as the Start button has been pressed The programme stage reached will be shown in the display as the programme proceeds Detailed information on programme sequences is given...

Page 51: ...rature is above 40 C Cancel programme OK With established decontamination programmes any contaminated water must be decontaminated using a disinfecting agent before it is discharged into the sewerage system Only then can the door be opened If a great deal of hot water is present in the wash cabinet when the programme is interrupted and the door is then closed quickly hot water can escape Danger of...

Page 52: ... OK or continue Clear If the water temperature is above 40 C Cancel programme OK Open the door Caution Water and items in the machine may be hot Danger of burning or scalding Where a chemical disinfection programme has been used be aware that steam may contain high quantites of disinfecting agent Rearrange the load Follow infection control regulations and wear protective gloves Close the door care...

Page 53: ...onnection between the washer disinfector and an external appliance Process documentation using an external printer The connector marked Printer is used for connecting an external printer to the serial interface An RJ45 Sub D adapter is needed for connecting the washer disinfector to the external printer via an RS 232 interface Instructions on how to set the print functions of an external printer a...

Page 54: ...cal measurements will be taken Seals will be tested for water tightness All relevant measuring systems will be safety tested including error message displays All safety mechanisms Process validation The standard of cleaning and disinfection in the disinfection programmes must be confirmed by the user as a routine matter In some countries national regulations guidelines and recommendations also app...

Page 55: ...s to clog up They should therefore be checked daily and cleaned if necessary This machine must not be used without all the filters in place Watch out for glass splinters needles etc on the filters in the wash cabinet Danger of injury Cleaning the coarse filter Press the two lugs together remove and clean the coarse filter Put the clean filter back in position and press until it clicks in place Mai...

Page 56: ...icro fine filters To unscrew the micro fine filter take hold of the two lugs and turn twice in an anti clockwise direction Then remove together with the flat filter Clean the filters Replace the filters by carrying out the above steps in the reverse order Ensure that the flat filter sits flat in the base of the wash cabinet Maintenance 56 ...

Page 57: ...y baskets out of the wash cabinet Spray arm on top basket or mobile unit if present Loosen the nut on the spray arm and take the spray arm off Metal nuts have a left hand thread Ceramic nuts have a right hand thread Unscrew the upper spray arm Loosen the knurled thumb nut to unscrew the lower spray arm After cleaning the spray arms fit or screw them back into position After replacing the spray arm...

Page 58: ...se on stainless steel To help prevent resoiling fingermarks etc a stainless steel conditioning agent available from the Miele Spare Parts Department or via the Internet depending on country can also be used Do not use any cleaning agents containing ammonia or thinners as these can damage the surface material Never clean the machine or near vicinity with a hose or a pressure washer Cleaning the was...

Page 59: ...nhindered through all jets sleeves and hose adapters Make sure caps and closures on sleeves are correctly located and where applicable Make sure that the spray arms rotate freely Make sure the spray arm jets are free of any blockages See Cleaning the spray arms Check whether there are magnets on the ends of the spray arms Make sure no metal parts have been attracted to the magnets on the ends of t...

Page 60: ...de of the filter must face the front Replace the filter grille and push it upwards to secure it Close the front of the control unit cabinet After replacing the coarse filter the operating hours counter must be reset To do this Select the CHANGE TA COARSE programme and press h to start it When the service programme has ended a message will appear in the display Confirm this message by pressing the ...

Page 61: ...ing and hinge them upwards Remove the coarse filter housing Pull the fine filter out of its holder and replace it with a new one Replace the coarse filter housing and hinge the securing screws back downwards Tighten the securing screws Close the front of the control unit cabinet After cleaning and replacing the HEPA filter the operating hours counter must be reset To do this Select the CHANGE TA F...

Page 62: ...e filters in the wash cabinet are blocked If the message Check wash cabinet heating appears water has not heated up in the wash cabinet and the programme is taking too long proceed as follows Remove the cause of the fault Take off the service panel Press the reset button on the heater limiter located on the right hand side of the plinth If this switch trips again contact the Miele Service Departme...

Page 63: ... Disconnect the machine from the mains electricity supply Turn off the stopcock and unscrew the water inlet hose Clean the large area filter 1 and fine filter 2 and replace with new filters if necessary Replace filters and the seal Make sure they are sitting correctly Reconnect the inlet hose to the stopcock making sure it goes on correctly and is not cross threaded Open the stopcock gradually to ...

Page 64: ...ll error messages that can appear in the display is given in the Programming Manual under Messages If having followed the advice in the operating instruction manual you are still unable to resolve a problem please call the Miele Service Department see the end of this booklet for contact details N B A call out charge will be applied to service visits where the problem could have been resolved as de...

Page 65: ... able to withstand the effects of steam and condensation The machine must be installed correctly and levelled Any unevenness in the floor level can be compensated for and the height of the machine raised or lowered by adjusting the four screw feet When the feet are screwed in the machine can be moved backwards and forwards on rollers Installation 65 ...

Page 66: ... switched off there must be an all pole contact gap of at least 30 mA in the isolator switch For extra safety it is advisable to protect the machine with a suitable residual current device The mains connection cable may only be replaced by an original Miele spare part or an appropriate cable with wire end ferrules Check that the phase rotation is correct when connecting the machine Failure to do s...

Page 67: ... 0 250 kPa and for an AD water connection is 0 150 kPa Otherwise fill times will be too long The maximum permitted static water pressure is 1000 kPa If the water pressure is not in the range specified above please contact the Miele Service Department for advice The machine is supplied as standard for connection to a cold coded blue and a hot coded red water supply up to a max temperature of 70 C T...

Page 68: ...ater intake time is automatically extended The AD pressure tested hose marked H2O pur with a 3 4 threaded union must be connected to the on site AD stopcock for purified water Note If the machine is not going to be connected to an AD water supply the cleaning and disinfecting programmes will have to be altered by a Miele Service technician The inlet hose will remain on the rear of the machine Opti...

Page 69: ... is disconnected from the main power supply switch off or unplug the power Turn off the mains water tap Place the seals on both sides of the non return valve Connect the female end of the non return valve to the water tap Connect the filter to the male end of the non return valve Connect the inlet hose to the filter Ensure that all connections are screwed into position correctly The connection poi...

Page 70: ...e sited between 0 6 m and 1 m above the lower edge of the machine If it is lower than 0 6 m lay the hose in a curve at a height of at least 0 6 m The drainage system must be able to take a minimum drainage flow of 50 l min The drain hose is approx 1 5 m long is flexible and has an internal diameter of 22 mm It must not be shortened Hose clips are supplied for securing it in position A longer drain...

Page 71: ...m condenser Approx 2 4 l min Ambient temperature 5 C to 40 C Relative humidity Decreasing proportionately to 80 for temperatures to 31 C 50 for temperatures to 40 C Altitude Max 1500 m Degree of soiling P2 according to IEC EN 61010 1 Protection category according to IEC 60529 IP20 Dust permeation Noise level in dB A Sound level LpA during cleaning and drying phases 70 Test marks VDE radio interfer...

Page 72: ...Options Fitting kit for DOS S 20 and DOS NA 120 dispensing systems Connecting module AM10 Conductivity measurement module Optional extras 72 ...

Page 73: ... where existing procedures are not satisfactory It is particularly suitable for instruments such as those used in high frequency surgery orthopaedic surgery as well as for instruments which have dried out because of the length of time between using them and reprocessing them It is also suitable for antiseptic circumstances The OXIVARIO PLUS process is designed to prevent transmission of iatrogenic...

Page 74: ...ther chemicals This could cause a serious chemical reaction e g the release of harmful vapours or gases Only use tenside cleaning agents supplied by Ecolab or Dr Weigert Connecting the H2O2 solution container The connection hose for the H2O2 solution container is identified by a black label The connection hose is supplied without a safety cap as the container for hydrogen peroxide will vary depend...

Page 75: ...vironment They are however essential for the correct functioning of your machine Please do not therefore dispose of it with your general waste Please dispose of it at your local community waste collection recycling centre or contact your dealer for advice Ensure that it presents no danger to children while being stored for disposal Disposal of your old machine 75 ...

Page 76: ...44 6 1 0 1 6 4 222 6 A B 0 A 1 0 A 1 C 4 222 C 8 9 B 1 9 3 5 B 0 1 D 1 0 1 4 A D 222 5 8D 6 B0 BE 9 4 222 9F 8 8 8 D 9 0 G4 1 4 222 6 A 6 H 5 6I 6 5 1 0 1 4 222 F 6 5 2 7 6 6 A 0 A 1 9 D 222 9 4 2 0 4 222 4 8 2 D A 1 0 A 1 1 4 222 7 37 ...

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