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Special processes

64

Optional OXIVARIO system

Intended use

This washer disinfector can be set up or retro-fitted to use the OX-
IVARIO process by adding two additional dispenser pumps together

with a buffer tank for hydrogen peroxide solution H

2

O

2

. The DOS 2

dispenser is used for the H

2

O

2

 solution.

The OXIVARIO and OXIVARIO PLUS programmes are available for
this process.

The OXIVARIO process releases active oxygen under alkaline condi-
tions. The cleaning agent used must be tenside free and have a pH
value of between 11 and 11.5.

Areas of applica-
tion

The 

OXIVARIO

 process has an alkaline main wash making it suitable

for the reprocessing of surgical instruments where existing proced-
ures are not satisfactory. It is particularly suitable for surgical instru-
ments 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 iatrogenic prion

transmission (vCJD).

The cleaning process is gentle enough for instruments used in minim-
ally invasive surgery, including fibre optics, where the manufacturer
has declared that they are suitable for reprocessing with an alkaline
cleaning agent.

It is not suitable for anodised aluminium. 
Be aware that items made from alloys containing titanium such as
some implants, do not always state the material's compatibility.
Processing such items can result in colour changes, rendering any
coding on them ineffective. If in doubt please consult the manufac-
turer of the item.

Due to the high efficacy of these processes it is important to

lubricate joints and contact parts on instruments immediately after
reprocessing them.

Summary of Contents for G 7825

Page 1: ...ctions Washer disinfector G 7825 G 7826 To avoid the risk of accidents or damage to the machine it is essential to read these instructions before it is installed and used for the first time en GB AU NZ M Nr 10 318 470 ...

Page 2: ...2 ...

Page 3: ...bottles 24 Operating theatre shoes 26 Laboratory equipment 27 Programme chart 29 Transfer trolley for loading and unloading the machine 30 Adjusting the foot pedal 30 Loading and unloading 31 Chemical processes and technology 33 Chemical reactions 33 Dispensing liquid chemical agents 38 Dispensing systems 38 Fill DOS X container 39 Filling the containers with chemical agents 39 Check dispensing sy...

Page 4: ...ng the wash cabinet 54 Cleaning the door seal 54 Mobile units modules and inserts 55 Printer optional 56 Renewing the paper roll 56 Replacing the cartridge 56 After sales service 57 Converting the type of heating 58 Converting from steam to electric heating or from electric to steam 58 Electrical connection 59 Electromagnetic compatibility EMC 60 Plumbing 61 Technical data 62 Optional extras 63 Op...

Page 5: ...roducible results and should be used in preference to processing them by hand Where dis infection is required for the protection of staff and or patients a thermal disinfection programme e g the DESIN Vario TD programme should be selected Heat sensitive theatre shoes are an exception to this the CHEM DESIN programme is available for these According to the A0 concept described in EN ISO 15883 1 the...

Page 6: ...rators For routine operation of the washer disinfector operators must be in ducted and receive regular training in the basic functions of the washer disinfector and loading it They require a basic knowledge of machine reprocessing of medical products Tasks for daily routine work are located in operating levels A and C Supervisors Advanced knowledge of the machine based processing of medical device...

Page 7: ...verview Unclean infeed side a Drying unit TA optional b Handle c Profitronic electronic control system also see Programming manual d Controls e Master switch with Emergency cut off button f Drop down door closed g Service panel ...

Page 8: ...Guide to the appliance 8 Unclean infeed side a Filter combination b Drop down door open c Containers for dispensing systems DOS 1 DOS 3 and optional DOS 2 DOS 4 ...

Page 9: ...Guide to the appliance 9 Clean outfeed side G 7826 only a Handle b Door release c Drop down door closed d Printer optional G 7825 on the unclean infeed side e Service panel ...

Page 10: ... can appear in the display is provided in the Programming Manual b On Off button I 0 c Cursor button left Moves the cursor to the left to the previous menu point to the previous parameter to the previous input position d Cursor button right Moves the cursor to the right to the next menu point to the next parameter to the next input position e Minus button Selects programmes from position 24 upward...

Page 11: ...rs pre settings e g service parameters g Door switch h Start button Starts programmes Activates input mode Confirms activated values and settings Confirms menu points for entry into the relevant sub menu i Stop button Cancels a programme Exits from an input screen without saving Exits from menu screen j PC interface k Programme selector Selects programme places 1 23 ...

Page 12: ... rect use or operation of the machine This washer disinfector is intended for indoor use only Please pay attention to the following notes to avoid injury This washer disinfector must be commissioned serviced and re paired by a Miele authorised and trained service technician only To ensure compliance with the GLP guidelines and Medical Device Dir ective Miele repair and maintenance contracts are re...

Page 13: ...de in the disinfecting agent it is essen tial to regularly check door seals and make sure that the steam con denser 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 va pours or chemical agents follow the emergency instructions given in the manufacturer s safety...

Page 14: ...s should 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 products are processed by means of thermal disinfection Disinfection of heat sensitive items e g theatre shoes can be carried out using the CHEM DESIN progra...

Page 15: ...ntial that the manufacturer s instructions are followed The chemical agent must only be used for the application it is designed for and in the situation specified to avoid material damage and such dangers as a severe explosive chemical reaction e g an explosive oxyhydrogen gas reaction In critical applications where very stringent requirements have to be met it is strongly recommended that all the...

Page 16: ...are required for Consult Miele for details on the type of accessories that can be used Only use Miele mobile units baskets and inserts with this washer disinfector Using mobile units and inserts made by other manufac turers or making modifications to Miele accessories can cause un satisfactory cleaning results for which Miele cannot be held liable Any resultant damage would not be covered by the g...

Page 17: ...afety reasons ensure the machine is com pletely drained of any residual chemical agent Observe safety regula tions and wear safety goggles and gloves Remove the door lock or make it inoperable so that children cannot accidentally shut themselves in Then make appropriate arrange ments for its safe disposal Machines with a tank must be emptied of water first Miele cannot be held liable for damage ca...

Page 18: ... will select the allocated programme The processes for coding the mobile unit and for changing pro gramme places 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 metallic objects on the strip can result in the coding being in correctly re...

Page 19: ... and clean them properly if necessary Is the mobile unit correctly connected to the water supply Are the removable modules jets sleeves and other rinsing attach ments correctly connected Are all chemical containers sufficiently filled At the end of each programme The following must be checked at the end of every programme Carry out a visual check of the load for cleanliness Check that all hollow s...

Page 20: ...s should be placed in the centre of the bas ket if possible to ensure better water coverage Take apart any items which can be dismantled according to the manufacturer s instructions and process the individual parts separ ately from each other Lightweight items should be secured with a cover net e g an A 6 and small items placed in a mesh tray to prevent them blocking the spray arms or being attrac...

Page 21: ...ing partic ular attention to regulations regarding infectious diseases and epi demics Ensure that no acid or solvent residues especially hydrochloric acid or chlorides get inside the wash cabinet Unloading instru ments Instruments should be unloaded dry Chemically pre treated instruments must be rinsed thoroughly before processing in the washer disinfector to avoid a significant build up of foam ...

Page 22: ...ssed de ionised water must be used for the wash cycles and the final rinse These containers must not be reprocessed with an alkaline cleaning agent in a 93 C programme with 10 minutes holding time according to 18IfSG or Cf PP 01 01 in the U K For reprocessing OP containers to an A0 600 disinfection standard the CONTAINER 600 programme must be programmed in retrospect ively by Miele Mobile units fo...

Page 23: ...of the mobile injector unit is designed to take E 441 1 inserts or E 142 mesh trays for processing solid instruments Plastic fibre cover nets must not be used in washer disinfectors which are used to process hollow ophthalmic instruments with nar row lumen The mobile unit for ophthalmic instruments is supplied with its own operating instructions Anaesthetic instruments Anaesthetic instruments shou...

Page 24: ...n 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 bac teria A sufficient drying time is therefore absolutely essential Inserts for baby bottles and teats are supplied with their own operat ing instructions E 750 frame Place the frame centrally in the t...

Page 25: ... Lower level with 3 E 135 Upper level with 2 E 135 The two blocked corners in the inserts should be located over the positions marked with an X on the drawing The jets of water can not get into the bottles properly in these positions to clean them ...

Page 26: ...rammed in ret rospectively by Miele To establish the effectiveness of chemical disinfecting agents for dis infection consult the manufacturer Theatre shoes should be cleaned and disinfected in a machine in stalled specifically for this purpose only If theatre shoes are to be processed in a washer disinfector which is used for other ap plications a risk assessment must be carried out by the user Mo...

Page 27: ... Erlenmeyer flasks round bottomed flasks measuring cylinders and pipettes require in jector units or injector modules The injector units and modules come with their own operating in structions When loading please note Place petri dishes in the appropriate insert with the soiled side fa cing towards the centre Place pipettes with the pointed end facing downwards Quarter segment inserts should be po...

Page 28: ...n particular hydrochloric acid must not be placed in the cabinet Scoop nutrient media Agar out of petri dishes Shake out any blood residues and remove any clots If necessary rinse the wash load briefly with water to prevent coarse soiling entering the machine Remove stoppers corks labels sealing residues etc Secure small items such as stoppers and taps in suitable baskets for small items It may be...

Page 29: ... applications LAB INTENSIVE Programme for moderate to heavy soiling with moderate to high rinse requirements for removing organic residues such as proteins cell and tissue cultures and some oils and greases for some inorganic residues e g pH 7 water soluble metallic salts for preparative and analytical applications ORGANIC Programme for moderate to heavy soiling with moderate rinse re quirements f...

Page 30: ...washer disinfector and from there to the checking and packing table The height of the transfer trolley has to be adjusted by Miele The height should be set so that the open machine door is held under neath the side catches on the transfer trolley The position of the foot pedal on the transfer trolley may also need to be changed Adjusting the foot pedal Unscrew foot pedal Loosen counter nut on adju...

Page 31: ...transfer trolley using both hooks To lift the mobile unit step down on the transfer trolley foot pedal Push the transfer trolley under the open door on the washer disin fector as far as it will go The mobile unit will then sit over the door Secure the brakes on the wheels To lower the mobile unit step right down on the foot pedal ...

Page 32: ...ransfer trolley up to the washer disinfector so that the machine door is held underneath the side catches on the transfer trolley Pull the loading trolley up to the stopping point on the open door so that it can be lifted with the transfer trolley and moved away ...

Page 33: ...ion between chemical agents and soiling Heavy foaming during a programme affects cleaning and rinsing results Foam escaping from the wash cabinet can cause damage to the washer disinfector Cleaning processes cannot be regulated and validated where there has been a build up of foam Establish the cause of the foam and rec tify it Check the process used regularly to mon itor foaming levels See inform...

Page 34: ...tructions and recommendations Carry out a regular visual check of the dispensing system for any damage Regularly check the flow rate of the dis pensing system Chemical agents can damage elastomers and plastics in the washer disinfector and accessories Follow the chemical agent manufacturer s instructions and recommendations Carry out a regular visual check of any ac cessible elastomers and plastic...

Page 35: ...t be set to ensure the whole process is foam free or very low foaming Please observe chemical agent manufac turer s instructions De foaming agents especially silicone based ones can cause the following deposits to build up in the cabinet deposits to build up on the load damage to elastomers and plastics in the washer disinfector damage to certain plastics e g polycar bonate and plexiglass in the l...

Page 36: ...bstances can lead to a heavy build up of foam during washing and rinsing some disinfecting agents and dishwash ing detergents reagents for analysis e g for microtiter plates cosmetics hygiene and care products such as shampoos and creams analytical applications active foaming agents such as tensides Thoroughly rinse items in water before hand Select a cleaning programme with at least one short pre...

Page 37: ...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 chem ical agents Select a cleaning programme with at least one short pre rinse in cold water Non precious metals such aluminium mag nesium and zinc can release hydrogen when processed with...

Page 38: ...Dispensing system DOS 4 green for low foaming disinfecting agents suitable for machine use or for an additional cleaning agent It can dispense up to 120 ml min The correct amount of liquid agent etc required for the application chosen will then be dispensed through these dispensing systems If a dispensing system is to dispense different chemical agents the change of chemicals must be carried out b...

Page 39: ...a message to that effect appears in the display e g FILL DOS 1 CONTAINER This will prevent air locks and the subsequent requirement to vent the system Filling the containers with chemical agents Switch the machine off using the master switch Open the service panel and swing to the left Remove the container from the washer disinfector Unscrew and remove the siphon Replenish the container with the c...

Page 40: ...nt container will appear in place of the X Refill the container or replace it with a full one Vent the dispensing pipework of the system concerned using the appropriate service programme If a container is not being used the level query for the unused dis pensing system can be turned off to avoid the error message see Machine functions container query in the Programming Manual supplied with the was...

Page 41: ...ready for operation Switching on Press the I O button Depending on the operating level set the following will appear in the display Operating level Message in display A and B The last programme selected C AUTOMATIC MOBILE UNIT RECOGNITION D Choose from The last programme selected Programme chart Programming The display background lighting switches itself off automatically after approx 15 minutes P...

Page 42: ...o gramme parameters or the INTERLOCK YES function is active Opening the door Press the door button and holding onto the door grip open the door Do not touch the heating elements under the wide area filter when opening the door directly after the end of a programme You could burn yourself They remain hot for some time after the programme has finished Closing the door Lift the door upwards and push ...

Page 43: ...s A B C and D are shown in the display Select the operating level you want using the or buttons Press to confirm selection Enter code when requested by the display The code is set ex works to 0000 To enter the code Press the Start button 0000 will appear Enter numbers using the and buttons Select the cursor posi tion with the or buttons Press to confirm code If you enter the wrong code FALSE CODE ...

Page 44: ...ammes have been made freely accessible se lect the one required using the programme selector Press the Start button Further information about programme selection can be found in the Programming manual in Operating level A B Free pro gramme selection In operating level B there are three ways of selecting a programme 1 Programme places 1 23 can be selected using the programme se lector 2 Programmes ...

Page 45: ...sult in the coding being in correctly read Before starting a programme it is absolutely essential to check that the programme shown in the display is the correct one for the mobile unit being used Otherwise inadequate cleaning or disinfection could be the result Please make sure that the places assigned for the programmes using Automatic mobile unit recognition are not changed around arbitrarily O...

Page 46: ... in the Programming manual for further in formation on switching off the flashing lighting Cancelling a programme A programme can only be interrupted or cancelled in operating levels B and D When testing to EN ISO 15883 1 or Cf PP 01 01 the programme must not be interrupted or cancelled In operating levels B or D Press the Stop button The programme is interrupted The following will appear in the d...

Page 47: ...llowing will appear in the display CANCEL OR CONTINUE Open the door For throughfeed machines The setting at Machine function Door interlock determines which door of the washer disinfector can be opened see Programming manual The door on the unclean side can always be opened regardless of the setting The door on the clean side can then only be opened when the ma chine is set to INTERLOCK YES Washer...

Page 48: ... suitable models Pin configuration in the 9 pole sub D connector on the interface cable 5 GND base 3 TXD transmit 2 RXD receive 1 4 6 linked 7 8 linked A standard null modem or laplink cable can be connected The extension cable to the printer PC must not exceed 10 m in length Please note the following when connecting a printer or PC Only use an industry standard PC or printer e g in Germany TÜV or...

Page 49: ...n the wash cabinet Water inlet and drainage Internal and external dispensing systems Spray arms Filter combination Sump including drain pump and non return valve All mobile units baskets modules and inserts and where applicable Steam condenser Drying unit Any printer connected to the machine The following operational tests will be carried out within the frame work of the maintenance A programme wi...

Page 50: ...he Medical Devices Directive MDD The Medical Devices Operation Ordinance National Health and Safety regulations regarding disinfection e g CFPP 01 01 or CFPP 01 05 depending on machine in the UK Routine checks Before the start of each working day the user must carry out a num ber of routine checks A check list is supplied with the machine for this purpose The following need to be inspected All fil...

Page 51: ...g the filters Cleaning the fine filter Remove the fine filter and clean it under running water Replace the fine filter Cleaning the flat filter Remove the flat filter and clean it under running water Replace the flat filter ...

Page 52: ...he right beside the heater element block there are two filters for protecting the circulation pumps Pull the filters straight up from their brackets and clean under run ning water Replace the filters by carrying out the above steps in the reverse or der Check that the filters are positioned correctly ...

Page 53: ...ut of the wash cabinet Loosen the fastening on the spray arm with an SW 60 spanner and pull the spray arm upwards or downwards to remove Spray arms in mobile units mod ules Turn the nut left hand thread together with the spray arm clock wise and then pull the spray arm downwards and off If there is considerable visible wear on the bearing on the spray arm contact Miele Service as this can result i...

Page 54: ...cleaning agent for use on stainless steel To help prevent re soiling fingerprints etc a suitable stainless steel conditioner can be used after cleaning 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 water hose or a pressure washer Cleaning the wash cabinet The wash cabinet is generally self clea...

Page 55: ...le units inserts Are all jets sleeves and hose adapters clear so that wash water can flow through unhindered Are all caps and fasteners securely attached to the sleeves 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 Are the screws in the magnetic rails for automatic mobile unit re cognition AWK tightly...

Page 56: ... Guide the paper through the slot in the front panel then close the front panel Replacement paper rolls 58 mm wide outer diameter approx 50 mm can be purchased from the Miele Spare Parts Department or from an office stationery supplier Replacing the cartridge Open the front panel of the printer at the upper edge and then open it downwards Pull the cartridge above the paper roll forward and out of ...

Page 57: ...rs An overview of all 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 De partment 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...

Page 58: ...onvertible you can use the STEAM ELECTRO or ELECTRO STEAM service programme to switch from one type of heating method to the other Select STEAM ELECTRO or ELECTRO STEAM see Opera tion B Free programme selection Press the Start button When the Service programme has ended a message will appear in the display To CONTINUE press ...

Page 59: ...en all open contacts Equipotential bonding should be carried out if required For technical data see data plate or wiring diagram supplied For increased safety it is recommended to protect the machine with a suitable residual current device RDC with a trip current of 30 mA Check that the phase rotation is correct when connecting the ma chine Failure to do so could have an adverse effect on the circ...

Page 60: ...o the mains power supply The washer disinfector s HF emissions are very low and are therefore unlikely to interfere with other electronic appliances in the vicinity Flooring in the installation area must be wood concrete or tiled Syn thetic flooring must be able withstand a relative humidity level of 30 to minimise the risk of electrostatic discharges The quality of the power supply should comply ...

Page 61: ...composition may cause precipitates to form requiring the use of softened water in the steam condenser The machine is designed for connection to cold hot and DI water If there is no hot water supply the intake valve for the hot water con nection should be connected to the cold water supply In the Water intake programme phase two valves can be controlled in parallel to shorten the programme duration...

Page 62: ...temperatures up to 31 C 50 for temperatures up to 40 C Altitude above sea level up to 1500 m Soiling level according to IEC EN 61010 1 P2 Overvoltage category according to IEC 60664 II Protection category according to IEC 60529 IP20 dust penetration Noise level in dB A sound pressure LpA during cleaning and drying phases 70 Test certificates awarded VDE radio and television suppressed mark MDD gui...

Page 63: ...er for process documentation PRT Dispensing systems DOS 2 and DOS 4 OXIVARIO kit Water softening Mains water with a hardness level higher than 0 7 mmol l 4 d Ger man scale needs to be softened Install an Aqua Softsystem G 8597 up to approx 40 dH 7 2 mmol l if required ...

Page 64: ...n 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 iatrogenic prion transmission vCJD The cleaning process is gentle enough for instruments used in minim ally invasive surgery including fib...

Page 65: ...e a serious chemical reaction e g the release of harmful va pours or gases 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 con tainer for hydrogen peroxide will vary depending on supplier Connect the supplier s safety cap to the connection hose black Then connect th...

Page 66: ...tentially hazardous to human health and to the en vironment They are however essential for the correct functioning of your machine Please do not therefore dispose of it with your house hold waste Please dispose of it at your local community waste collection recyc ling centre or contact your dealer for advice Ensure that it presents no danger to children while being stored for disposal ...

Page 67: ......

Page 68: ... miele ae United Arab Emirates United Kingdom Miele Co Ltd Fairacres Marcham Road Abingdon Oxon OX14 1TW Professional Sales Tel 0845 365 6608 E mail professional miele co uk Internet www miele professional co uk Miele Australia Pty Ltd ACN 005 635 398 ABN 96 005 635 398 1 Gilbert Park Drive Knoxfield VIC 3180 Tel 1300 731 411 Internet www miele professional com au E mail info miele professional co...

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