Miele PG 8535 Operating Instructions Manual Download Page 2

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Summary of Contents for PG 8535

Page 1: ...instructions Washer Disinfector PG 8536 To avoid the risk of personal injury or damage to the appliance it is essential that you read these operating instructions before installation and use M Nr 10 317 280 en CA ...

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Page 3: ...tart delay 22 Current faults 24 Reactivation 24 Opening and closing the door 25 Electric door lock 25 Opening the door with the emergency release 25 Water softener 26 Setting the water softener 27 Reactivation display 28 Refilling the softener with salt 28 Filling the salt container 29 Inserting the salt container 29 Executing the regeneration 30 Automatic mobile unit recognition 31 Spray arm moni...

Page 4: ...4 End of program 54 Turning off 54 How to cancel a program 55 Interrupting a program 56 Process documentation 57 Maintenance of the washer disinfector 58 Routine maintenance 58 Process validation 58 Routine checks 58 Cleaning the filters in the wash cabinet 59 Cleaning the coarse filter 59 Cleaning the surface and micro fine filters 60 Cleaning the spray arms 61 Cleaning the control panel 62 Clean...

Page 5: ...ater inlet 71 DI water connection pressure resistant for 60 1000 kPa pressure 72 DI water connection unpressurized for 8 5 60 kPa optional 72 Connecting the water drain 73 Technical Data 74 Optional equipment 75 OXIVARIO and ORTHOVARIO Optional features 76 Intended Use 76 Applications 76 Safety instructions and warnings 77 Connecting the H2O2 container 77 Disposing of an old appliance 78 Contents ...

Page 6: ...tions This washer disinfector should only be installed maintained and repaired by a Miele service technician For best compliance with Good Laboratory Practice guidelines and regulations governing the use of medical products a valid Miele service and repair contract is recommended Work performed by unqualified persons can place the user at considerable risk of harm Do NOT install the washer disinfe...

Page 7: ...cal lock to open the door there is the danger of scalding and heat or chemical burns If disinfectants have been used there is also the danger of inhaling toxic vapour The door seal and the operation of the steam condenser should be regularly checked as volatile toxic or chemical substances e g aldehyde in the disinfection agent may be created in the wash water during preparation Opening the door o...

Page 8: ...e processing of medical devices is carried out by means of thermal disinfection The disinfection of other items that are not heat resistant e g OR shoes can be carried out using the CHEM DESIN program with the addition of a chemical disinfectant The disinfection parameters are based on the recommendation of the disinfectant manufacturer Always observe their specifications for handling applications...

Page 9: ...l process related factors processing chemicals water quality etc be discussed in advance with Miele In addition for applications that demand especially stringent cleaning and rinsing results e g chemical analysis the operator must ensure that quality control occurs on a regular basis to meet the standards involved Only use mobile units baskets and inserts as intended by the manufacturer Hollow ite...

Page 10: ...he Washer Disinfector Caution Comply with the Operating Instructions Caution Danger of electric shock Disposing of Your Old Washer Disinfector Any old washer disinfector may be contaminated by blood or other pathogens bodily fluids etc and therefore must be decontaminated before disposal For safety and environmental protection be sure to remove all process chemical residue Comply with safety regul...

Page 11: ...ver a range of equipment and items For standardized results it is preferable to machine wash lab surgical instruments and equipment When disinfection is required to protect staff and or patients the preference is for thermal disinfection e g with the DES VAR TD process An exception are temperature sensitive OR shoes which can be processed using the CHEM DESIN program According to the A0 concept de...

Page 12: ...process validation User profiles Daily routine operators For daily routine tasks the operating personnel must be instructed in the basic functions and the loading of the washer disinfector and should receive regular training Basic knowledge of the machine based processing of medical devices is required Daily routine work takes place on operating levels A and C Daily routine supervisors Advanced kn...

Page 13: ...r access for validation eFiller port for salt container water softener fFilter combination gService panel hContainers for DOS 2 and DOS 4 dispensing systems optional iDOS drawer jContainers for neutralizer red and liquid detergent blue kDrying unit lReset button Guide to the washer disinfector 13 ...

Page 14: ...her disinfector is not in use the display automatically switches off after approx 10 min To turn the display back on touch any button Fault messages are shown in the display together with a corresponding number See the Programming Manual for a table of all the fault numbers Guide to the washer disinfector 14 ...

Page 15: ...tons e Selection buttons Shift position of marking in display changed marked value scroll Retrieve context menu display user defined operating parameters during program operation hOK Button confirm marked menu item or selected value acknowledge fault messages acknowledge dialogue messages Access A0graph during program operation Viewing the temperature curve during the course of the program sequenc...

Page 16: ... buttons to move through the menu items The marking in the display can be moved using the e buttons Use the OK button to confirm messages or settings and change to the next menu or another menu level To select a menu item mark it using the e selection buttons then confirm with the OK button A maximum of three menu items or selections can be shown in the display A scroll bar at the right of the dis...

Page 17: ...is running the following appears in the display the program name the operating level the program segment the water temperature or the air temperature in the program segment Dry the estimated time remaining or the program time completed so far any fault messages or notices Guide to the washer disinfector 17 ...

Page 18: ...er Start Delay In operating level D current fault messages are also displayed if applicable To enter the context menu simultaneously press the e buttons for at least 3 seconds The context menu appears in the display Context menu B Change display language F Change operating level Delay start Use the e buttons to move through the menu items Context menu 18 ...

Page 19: ...s that all reports and print outs will continue to be done in the system language To select the menu item Change display language use e then activate it with OK The flag J after the text Change display language is to help you identify an unfamiliar language In this case continue to change the menu item until you see the flag J Select the desired language and confirm with OK The selected language a...

Page 20: ...ogramming and Settings J menu The context menu can be used to switch between operating levels To help prevent unauthorized access to the settings a code is required to change operating levels To change the codes for existing users or to enter new users you must be a registered administrator The Administrator is registered by Miele Service Simultaneously press the e buttons for at least 3 seconds T...

Page 21: ... operating level B 0 F F F Enter code The e buttons change the numbers the OK button confirms the set value and changes to the next number to be entered The control unit switches to the selected operating level To leave the context menu use C If an incorrect entry is made Code invalid will appear in the display The message can be cancelled by using OK You can then restart the operating level chang...

Page 22: ...ctivate and select Yes Delay start B Activate Yes Delay start To use this feature go to Delay start and confirm The start time menu will appear Delay start B 17 48 Enter time Use the numbers to enter the desired start time then confirm Keep pressing the C button until the Main menu appears in the display To select a program go to Program overview Programme overview B REACTIVATION DES VAR TD DES VA...

Page 23: ...will be asked to confirm Cancel start time Yes No To cancel the program start select Yes and confirm The automatic program start is cancelled The display reverts to the program overview The Delay start function is de activated If you select No the Delay Start option will continue Once the program has run the Delay start function is automatically de activated The Delay start function can also be de...

Page 24: ...d under this menu item Select the menu item and confirm using OK The current fault messages are displayed Use OK to scroll through the fault messages To leave the context menu use C Reactivation This menu option is shown on operating level C only as long as no program is running All other steps in connection with the water softener are described in the chapter Water softener Context menu 24 ...

Page 25: ...ure should only be used when it is not possible to open the door normally for example during a power failure For all DESIN programs please read the Important safety information If you bypass the electrical lock to open the door there is the danger of scalding and heat or chemical burns If disinfectants have been used there is also the danger of inhaling toxic vapour Do not touch the heating elemen...

Page 26: ...provide information about the hardness of the tap water in your area The factory default for the water softener is set to a hardness of 19 gr gal 340 ppm CaCO3 If the actual water hardness is different even if it is below 4 gr gal the factory default setting will need to be changed using the electronic control If the water hardness is known to fluctuate e g 8 17 gr gal always program for the highe...

Page 27: ...9 30 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 20 40 50 70 90 110 130 140 160 180 200 220 230 250 270 290 310 320 340 360 380 400 410 430 450 470 490 500 520 540 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 560 580 590 610 630...

Page 28: ... salt cattle salt or de icing salt These salts can contain components that are insoluble in water and which could damage the water softener The salt container holds approximately 2 kg of salt If only pure evaporated salt with a fine grain size is available please consult Miele Service Pure evaporated salt with a grain size larger than 4 mm cannot be used NEVER fill detergent or similar into the sa...

Page 29: ...Inserting the salt container Remove the mobile unit from the wash cabinet Screw off the plastic lid at the top right of the wash cabinet A small amount of residual water is located in the plastic lid which can be very hot depending on the previous program sequence Insert the salt container and screw tight Water softener 29 ...

Page 30: ...t may be still be present in the salt container after regeneration Execute the menu option REACTIVATION again for a complete dissolution of the salt and to flush the softener Then Switch off the washer disinfector Open the door Carefully unscrew the salt container in order to any water presser to subside Do not use force If the container cannot be removed manually contact Miele Service The salt co...

Page 31: ... is inserted into the machine and the washer disinfector door closes the automatic mobile unit recognition selects the assigned program See the washer disinfector Programming Manual for information on how to code a mobile unit and assign programs Make sure that no metallic parts or pieces are stuck to the magnetic strip or its underside Attached metallic objects can cause the coding to be misread ...

Page 32: ...lso fitted with spray arms using speed monitoring This does not require a magnetic strip As per factory setting spray arm monitoring for the upper basket is deactivated This setting may be kept if only upper baskets without spray arm are used If upper baskets with and without spray arms are used and spray arm monitoring for the upper basket is activated the system will output the following query p...

Page 33: ... debris remove any coarse material and clean the coarse fine flat and micro fine filters as needed Is the adapter properly connected to the water supply for the spray arms and nozzles Are the process chemical dispensers full detergent neutralizer etc After EVERY program completion conduct the following visual inspection Inspect the labware or instruments for cleanliness Have any hollow items been ...

Page 34: ...attached to the magnetic strip on the automat ic mobile unit recognition Deep based items should be arranged at an angle so that water can run off easily Tall narrow hollow items should be placed in the center of the mobile unit for best water coverage Mobile units with an adapter must be properly connected Modules must be properly connected to the mobile unit The spray arms must not be blocked by...

Page 35: ...n the locking ring c How to adjust the upper basket The height of the upper basket can be adjusted on three levels by 2 cm each Depending on the height selected for the upper basket and which inserts are used labware instruments of various heights can be arranged in the baskets On the right hand side the height of the upper basket is restricted by the connector for the salt container To adjust the...

Page 36: ...en when loaded into the mesh trays and staggered to avoid covering other instruments The mobile units for surgical instruments come with their own instructions for use When processing instruments for minimally invasive procedures e g minimal invasive surgery it is essential that the insides be thoroughly cleaned before washing Only the programs DES VAR TD and OXIVARIO optional are suitable for tho...

Page 37: ...low instruments e g rinse and suction handpieces and cannulae Silicone holders and stoppers fitted on the mesh tray fix and secure the instruments to the inlet hose of the mobile unit The lower level of the mobile unit is designed to take E 441 1 inserts or E 142 mesh trays to reprocess instruments without a hollow body In washer disinfectors used to reprocess narrow lumen ophthalmological instrum...

Page 38: ...am DES VAR TD AN If no sterilization will occur after washing germ growth will need to be inhibited during storage Because this requires thorough drying a sufficient amount of drying time must be selected The units for anaesthesia instruments come with their own instructions for use Application 38 ...

Page 39: ... markings Bottles that are stored for longer than 4 hours prior to processing must be filled with water to prevent food residues from drying on the surface If no sterilization will occur after washing germ growth will need to be inhibited during storage Because this requires thorough drying a sufficient amount of drying time must be selected The inserts for baby bottles and nipples come with their...

Page 40: ...on If OR shoes are processed with other applications in a washer disinfector the operator must assess the risks associated with this The following baskets can be used O 167 for shoe sizes up to 40 7 1 2 in Canada O 173 for shoe sizes up to 41 8 in Canada and U 168 1 for shoe sizes up to 45 11 1 2 in Canada Alternatively you can use E 484 inserts with E 487 supports for surgical shoes or E 489 for ...

Page 41: ...e How to load the machine Prepare items before loading Empty all glassware before loading into the machine Comply with all applicable infection control regulations Ensure that no acid or solvent residues especially hydrochloric acid or chlorides get inside the machine Remove all agar residue from Petri dishes Shake or scrape out all blood residue and clots from test tubes Remove all stoppers corks...

Page 42: ...h rinse requirements for removing organic residues e g proteins cell and tissue cultures and some oils and greases for some inorganic residues e g pH 7 water soluble metallic salts for preparation applications and analytical applications LAB PIPETTES Program for light to moderate soiling with moderate to high rinse requirements with a greater amount of water for pipettes PLASTIC Program for light ...

Page 43: ...inse requirements for the cleaning of heavily soiled items e g crude oil synthetic oils lubricants fuels and some natural oils not suitable for acid soluble residues such as metallic salts and amines The conversion to oil and grease resistant elastomers is recommended for organic residues such as oils and greases In addition the DOS NA 120 dispensing system PG 8536 or DOS G60 dispensing module PG ...

Page 44: ... 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 lead...

Page 45: ...cess chemical manufacturers Carry out a regular visual check of any accessible elastomers and plastics for damage Hydrogen peroxide can release large amounts 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 advise The following chemical agents can cause large amounts of foam to ...

Page 46: ...lease 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 If possible retrofit the washer disinfector with oil resistant elastomeres provided by Miele Dependin...

Page 47: ...lect a cleaning program 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 iro...

Page 48: ... the pre rinse Depending on 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 program with at least one short pre rinse in cold water Non precious metals such aluminium magnesium and zinc can release hydrogen when processed with ve...

Page 49: ...ucts e g neutralizers The dosing rate is 105 ml min Up to two additional dispensing systems can be installed optionally Flow rate Product s 120 ml min alkaline 20 ml min acidic The appropriate containers with the processing chemicals are placed into the upper drawer of the washer disinfector additional DOS modules optional Dispensing system DOS S 20 for dispensing acidic processing chemicals e g n...

Page 50: ...g system DOS 4 green for dispensing a special tenside detergent The dosing rate is 120 ml min The special option ORTHOVARIO makes the DOS 4 dispensing system unavailable for dispensing chemical disinfectants Dispensing systems The liquid processing chemicals can be loaded into 5 l plastic containers which are color coded to match the respective dispensing system s Use caution when handling process...

Page 51: ... Open the container and fill it with the appropriate processing chemicals always complying with the color coding Insert the suction tube into the container opening and screw it into place Make sure to observe the color coding Once the containers have been filled the message clears from the display Place the container in the dispensing drawer und close the drawer Adding liquid detergents and neutra...

Page 52: ...dispensing system clear it of air The level query for dispensing systems which are not being used can be turned off to avoid fault messages in the display see the Programming Manual Machine function Dosage Container lance Priming the dispensing system Whenever a container has been allowed to completely empty it must be primed cleared of air after refilling Select the corresponding service program ...

Page 53: ...button is located at the underside of the electronic control To activate it Pull out the dispensing drawer Push the Reset button The Profitronic is shut down and restarted Starting a program You can find detailed and important information regarding the Miele default programs in the program overview chart in the accompanying Programming Manual Any program or dosing changes in connection with the pr...

Page 54: ...units with automatic recognition AWK are properly coded Push the coded mobile unit into place in the washer disinfector Close the door Press the h start button The program runs Program sequence Once started the program proceeds automatically As it proceeds the program steps are shown in the display Detailed information on program sequences is available in the appendix to the Programming manual End...

Page 55: ... OK or continue Clear At water temperatures above 40 C Cancel programme OK In cases involving mandatory decontamination disinfectant must be added to the contaminated water before it can be released into the public water system In this event the door can be opened If there is a large volume of hot water in the wash cabinet when a program is interrupted and the washer disinfector door is closed too...

Page 56: ...temperatures above 40 C Cancel programme OK Open the door Caution Items in the machine may be hot There is the danger of burning or scalding In programs with thermochemical disinfection steam containing high levels of disinfectant can escape Arrange items securely Take all necessary infection control measures and wear gloves Slowly close the door If there is a large volume of hot water in the wash...

Page 57: ... switch A twisted Ethernet cable cross over is required for the direct Ethernet connection between the washer disinfector and an external device e g a PC Process documentation with external printer The Printer plug is intended for connecting an external printer to a serial interface An RJ45 Sub D adapter plug is supplied for the connection of the washer disinfector to an external printer via an RS...

Page 58: ...al testing all safety related measurement systems fault report the safety features Process validation It is the responsibility of the operator to routinely check that the required cleaning and disinfection processes are functioning properly In some countries this is also required by national legislation regulations or recommendations Operators are also required to conduct such checks under interna...

Page 59: ...should therefore be checked daily and cleaned if necessary The washer disinfector must not be used without all the filters in place Risk of injury due to glass splinters needles etc which are retained by the micro fine filter 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 Maintenance...

Page 60: ... the micro fine filter take hold of the two lugs and turn twice in an anti clockwise direction Then remove the micro fine filter together with the flat filter Clean the filters Replace the filters by carrying out the above steps in the reverse order Ensure that the filters sit flat in the base of the wash cabinet Maintenance of the washer disinfector 60 ...

Page 61: ...of the wash cabinet Spray arm on upper 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 arms check that...

Page 62: ...brasive stainless steel cleaner To help prevent re soiling fingerprints etc a stainless steel conditioner can be used after cleaning Do NOT use thinner or ammonium based cleaners They can damage the surface Do NOT hose down the washer disinfector or the immediate vicinity e g with a water hose or pressure washer Cleaning the wash cabinet The wash cabinet is generally self cleaning If you notice a ...

Page 63: ...that wash water can flow through Are all caps covers and fasteners securely attached to the spray sleeves if applicable Do the spray arms rotate freely Are the spray jets clogged See the section on Maintenance measures Cleaning the spray arms Are the magnets in place on the spray arm ends Are the magnets on the spray arms free of attached metal parts Is the magnetic strip of the automatic mobile u...

Page 64: ...the filter must face the front Re insert the filter mesh at the bottom then press it into place at the top Close the control cabinet drawer After changing the coarse filter you must reset the operating hours counter To do this Select CHANGE COARSE TA and start the program by pressing the h button When the service program has finished the display will show a message Confirm this message with OK The...

Page 65: ...er Unscrew the upper screws on the coarse filter housing and lift upward Remove the coarse filter housing Remove the fine filter and insert a new one Reinsert the coarse filter housing and flip the screws downward Tighten the screws Close the control cabinet drawer After changing the HEPA filter you must reset the operating hours counter To do this Select CHANGE FINE TA and start the program by pr...

Page 66: ...heating elements or when the filters in the wash cabinet are blocked If the fault message Inspect wash cabinet heater is displayed in the display proceed as follows Remove the underlying cause Open the service flap Press the reset button for the ther mostat on the right side of the plinth base If the thermostat is triggered again please contact Miele Service without delay Troubleshooting 66 ...

Page 67: ...e washer disinfector from the mains supply Turn off the shut off faucet 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 shut off faucet gradually to t...

Page 68: ...amming Manual for an overview of the various fault messages that can appear in the display If a fault occurs and cannot be corrected using the Operating Instructions and Programming Manual please contact Miele Service For contact information see last page of the operating instructions When contacting the service department you will need to quote the model and serial number of your washer disinfect...

Page 69: ...t are designed for use in commercial wash environments The washer disinfector must be in a stable and level horizontal position Use the front screw feet to compensate or adjust for unevenness in the floor The screw feet can be screwed out up to 10 mm If the screw feet are tightened all the way in you can use casters to move the washer disinfector forward and backward How to install the machine 69 ...

Page 70: ...t the machine be connected upstream to a ground fault circuit interrupter with a trip current of 30 mA To replace the power cord use only original Miele replacement parts or a suitable cord with core cable ends The rotational direction of motorized power units depends on the electrical connection of the appliance Connect the appliance in phase with clockwise rotating field Equalize the potentials ...

Page 71: ... The maximum permissible static water pressure is 1000 kPa 145 psi If the water pressure lies outside the range of 150 1000 kPa 22 145 psi please contact Miele service for advice The machine is designed for connection to cold water blue marking and hot water red marking up to 70 C max Connect the water intake hoses to the cold and hot water shut off faucets Connect the intake hose for the steam co...

Page 72: ... thread to the DI water shut off faucet If the washer disinfector is not connected to a DI source the wash and disinfection programs will need to be adjusted accordingly by Miele Service The water intake hose remains on the rear of the machine DI water connection unpressurized for 8 5 60 kPa optional For the connection to 8 5 60 kPa 1 24 8 8psi the machine must be modified if this has not already ...

Page 73: ...st be located between 0 6 m and 1 m above the lower edge of the washer disinfector 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 handle a minimum drainage flow of 50 l min The drain hose is approx 1 5 m long and flexible internal diameter 22 mm It must not be shortened Use the supplied hose clamps to secure it into position Long...

Page 74: ...nser approx 2 4 l min Room temperature 5 C to 40 C Relative humidity maximum linear decreasing to 80 for temperatures up to 31 C 50 for temperatures up to 40 C Altitude above sea level up to 1500 m Contamination level P2 as per IEC EN 61010 1 Ingress protection as per IEC 60529 IP20 ingress of dust Noise level in dB A peak LpA for cleaning and drying cycles 70 Certification marks CSA Health Canada...

Page 75: ...Options Retrofit kits for DOS S 20 and DOS NA 120 dispensing systems Connection module AM10 with potential free contacts Conductivity meter Optional equipment 75 ...

Page 76: ...rocess is especially suited to the preparation of surgical instruments i e from HF high frequency surgery orthopaedic surgery instruments that dry out during long delays until preparation and for instruments affected by antiseptics The OXIVARIO PLUS process is designed to prevent iatrogenic prion transmission vCJK The cleaning processes are gentle enough for minimally invasive instruments includin...

Page 77: ...A violent chemical reaction such as a flash fire may occur Only special tenside detergents from Dr Weigert should be used Connecting the H2O2 container The hose line for the H2O2 container is identified by a black label It is supplied without an adapter because the extraction systems for each container differ by manufacturer Connect the appropriate adapter from the manufacturer to the black hose l...

Page 78: ...ld waste can be detrimental to health and the environment This is why it is important NEVER to dispose of your old appliance in the regular household garbage Instead please contact your local community waste collection point to return and recycle electric and electronic appliances If the appliance is being stored for disposal please make sure it has been child proofed Disposing of an old appliance...

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