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.
Disposal of your old appliance or machine. . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
3
Description of the machine
This Miele washer-disinfector is
capable of cleaning a wide range of
medical and laboratory products, and
disinfecting them either thermally in
temperatures up to 95 °C or
chemo-thermally in temperatures up to
65 °C with the addition of a suitable
chemical agent in accordance with
general standards of hygiene and those
required for the containing of
epidemics.
Medical products include e. g. surgical
and minimally invasive instruments,
instruments and utensils used in
anaesthetics and intensive care, etc.
Laboratory products include e.g. wide
and narrow necked flasks, conical
flasks, measuring cylinders, pipettes,
beakers, Petri dishes etc.
Follow medical and laboratory product
manufacturer's instructions on how to
process their items by machine. The
DESIN vario TD programme provides
optimum protection for rigid fibre
optics, patient systems and surgical
motor systems which have been
declared by their manufacturers as
being suitable for machine processing.
Optional drying with sterile filtered hot
air is also available.
These cleaning processes use
hydrogen peroxide under alkaline
conditions to oxidise and remove
protein soiling. The cleaning agent
used must be tenside free and have a
pH value of between 11 and 11.5.
The OXIVARIO procedure has an
alkaline main wash making it
particularly suitable for the processing
of surgical instruments where existing
procedures are not satisfactory and is
very effective for the final stage of
instrument processing.
The cleaning process is gentle enough
for instruments used in minimally
invasive surgery, including fibre optics,
where the manufacturer has declared
that they are suitable for processing
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 manufacturer of the item.
This washer-disinfector is equipped to
run the OXIVARIO programmes. The
DOS 2 dispenser is used for the H
2O2
solution.
Two special programmes are available
for this cleaning process, OXIVARIO
PLUS and OXIVARIO.
4
Instruments processed using the
OXIVARIO PLUS or OXIVARIO
programmes must be very carefully
handled afterwards.
Description of the machine
Areas of application:
surgical instruments,
–
with the Vario-TD programme:
–
minimally invasive instruments can
be processed immediately after
being used,
anaesthetic and intensive care
–
instruments,
baby bottles and teats,
–
operating theatre shoes,
–
laboratory products used in research
–
and production as well as in all areas
of analysis and specimen taking,
including micro-biology and
biotechnology.
Instruments should preferably be
cleaned and then thermally disinfected
using the DESIN vario TD programme.
The parameters for thermal disinfection
in accordance with prEN ISO 15883-1
are 80 °C (+ 5 °C, - 0 °C) with a 10 min.
holding time or 90 °C (+ 5 °C, - 0 °C)
with a 5 min. holding time for the
inactivation of HBV.
In the U.K., reference should be made
to your local infection control officer for
guidelines of disinfection temperatures
and holding times at temperature in
accordance with HTM 2030.
In Germany, the parameters for
disinfection of a temperature of 93 °C,
with a holding time of 10 minutes,
correspond to effective areas A and B.
These have been adopted into the
official list for disinfection of instruments
in washer-disinfectors and
decontamination units, according to
section 3.2 § 18 IfSG by the Robert
Koch Institute (RKI) in Berlin (institute
for infectious diseases and
non-communicable illnesses).
The effective areas are defined as
follows:
A = Suitable for the destruction of
vegetative bacteria, including
myco-bacteria, fungi and fungal
spores.
B = Suitable for inactivating viruses
(including HBV and HIV).
The cleaning programme must be
chosen according to the type of soiling
and product requiring processing in
order to ensure that disinfection is
carried out correctly, no residues are
left behind and that subsequent
sterilisation can take place. Medical
devices are best processed using the
DESIN vario TD programme, or one of
the OXIVARIO programmes where
applicable.
This washer-disinfector is programmed
to carry out the final rinse with mains
water or AD water (aqua destillata =
purified or de-ionised water (VE), H
O
2
pure, demineralised water, aqua
purificata or distilled water where the
application requires this standard).
The water quality is of particular
importance for applications requiring
analytically clean laboratory glassware.
The type of chemical agents used will
depend on the analysis or analytical
methods being used.
This disinfector is equipped with a
steam condenser (DHK), drying unit
(TA) and water softener as standard.
Optional:
- DOS 4 for retro-fitting
5
Guide to the machine
Electronic controls
a Display
with screen saver;
i.e. background lighting switches off
automatically after 15 mins.
Press any button to switch the
display back on again.
– Cancels a programme
– Exits from input screen without
saving
– Exits from menu screen
j Service interface
kProgramme selector
Selects programme places 1-23
7
Guide to the machine
a Drying unit (TA)
b Container for neutralising agent
(red), liquid cleaning agent (blue),
hydrogen peroxide H
2O2
(black)
c Filter combination
d Salt reservoir
(for the water softener)
8
e Service panel
f Test point for validation
g Serial interface
- at the back of the machine (top left
behind the cover panel) -
This machine complies with all
relevant legal safety requirements.
Incorrect use can lead to personal
injury and damage to property.
Read these operating instructions
carefully before starting to use this
machine. This way you will avoid the
risk of accidents and damage to the
machine.
Keep these instructions in a safe
place for reference, and pass them
on to any future user.
Correct use
Warning and safety instructions
Please pay attention to the following
notes to avoid injury and damage.
The machine should be
commissioned and then
maintained only by a Miele authorised
and trained service technician. To
ensure compliance with the Medical
Devices Directive a Miele service
contract is recommended. Repairs and
other work by unqualified persons
could be dangerous.
Do not install the machine in an
area where there is any danger of
explosion or of freezing conditions.
This washer-disinfector is designed
for specialised applications only as
described in these operating
instructions. 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
or medical products and laboratory
ware 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.
The manufacturer cannot be held liable
for damage caused by improper or
incorrect use of the machine.
This equipment may only be used
in mobile installations such as
ships, caravans, aircraft etc. if a risk
assessment of the installation has been
carried out by a suitably qualified
engineer.
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 tested regularly, and
where there is any doubt the on-site
electrical 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 machine is dangerous.
Switch off at the mains immediately
and call the Miele Service Department
or an authorised and trained Miele Ser
vice Dealer.
Personnel operating the machine
should be trained regularly.
Untrained personnel must not be
allowed access to the machine or its
controls.
This machine is not a toy! To avoid the
risk of injury never allow children to play
on or near the machine, or to operate it.
-
9
Warning and safety instructions
Take care when handling chemical
agents such as cleaning agent,
neutralising agent, rinsing agent etc.
These may contain irritant or corrosive
ingredients. Do not use organic
solvents as these could cause an
explosion.
Follow all relevant safety procedures
carefully. Wear protective gloves and
goggles. With all chemical agents, the
manufacturer's safety instructions must
be observed.
The water in the machine must not
be used as drinking water.
Do not sit or lean on an open door.
The machine could tip up and be
damaged or cause an injury.
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
fumes. Baskets, inserts and utensils
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
if you open the door 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.
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 instruments and senstitive
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.
10
Warning and safety instructions
For decontamination in
accordance with official
regulations, the programme must not
be interrupted by pressing the I-0
button to switch off after START has
been pressed . Interrupting any other
programmes should also be avoided as
this will reduce cleaning, disinfection
and the final rinse results. If it is opened
the programme should be completely
repeated.
The standard of cleaning and
disinfection in the disinfection
programmes must be routinely
confirmed by the user. The process
should be regularly monitored using
thermo-electrical indicators and the
results should be fully documented.
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 of
chemo-thermal disinfection procedures
is the responsibility of the operator.
If there are toxic or chemical
substances in the suds solution
(e.g. aldehyde in the disinfecting agent)
you must be particularly vigilant of the
risks these carry should you need to
interrupt a programme and open the
door. The door seals and correct
functioning of the steam condenser
should be regularly monitored.
Theatre (OP) shoes should only be
cleaned and disinfected in a
machine installed specifically for this
purpose.
H2O2solution must only be used in
the special containers and
adapters provided by the Ecolab and
Dr. Weigert companies.
Important: observe the
manufacturer's safety instructions
as given on their safety data sheet.
Be especially careful when
handling H
solution. It is an
2O2
irritant chemical.
Observe all current safety instructions
pertaining to its use.
Wear protective gloves and goggles.
Empty containers must be
disposed of in accordance with the
manufacturer's instructions.
H2O2solutions must not be mixed
with other chemicals. This could
cause a serious chemical reaction, e. g.
the release of harmful vapours or
gases.
11
Warning and safety instructions
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 process.
Where a chemical additive 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.
The machine is designed for
operation with water and
recommended additive chemical
agents only. Organic solvents must not
be used in this machine, as there is the
danger under certain circumstances of
fire or explosion. Although this is not the
case with all organic solvents, other
problems could arise with their use, for
example damage to rubber and
synthetic materials.
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).
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.
Please follow the advice on
installation in these instructions
and the separate Installation
Instructions.
12
Warning and safety instructions
Using accessories
Only use genuine Miele
accessories with this machine.
Consult Miele on the type and
application of such equipment.
Only use Miele mobile units,
baskets 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.
Disposal of your old machine
Before throwing an old machine
away, it must first be made
unusable. Disconnect from the mains
and cut off the cable as close to the
machine as possible.
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 and
cleaning agent. Observe safety
regulations and wear safety goggles
and gloves.
Make the door lock inoperable, so that
children cannot accidentally shut
themselves in. Then make appropriate
arrangements for the safe disposal of
the machine.
For tank system machines ensure that
any water is emptied out of the tank.
The manufacturer cannot be held
liable for damage caused by
non-compliance with these Warning
and Safety instructions.
13
Opening and closing the door
Electro-thermal door lock
This machine is equipped with an
electro-thermal door lock.
The door can only be opened when:
the electricity supply to the machine
–
is switched on,
the master switch I-0 is pressed in,
–
and
a cleaning or disinfection programme
–
is not in progress.
To open the door
^ Press the 5 door button, and holding
onto the door grip open the door.
Do not touch the heating
,
elements if you open the door during
or directly after the end of a
programme: you could burn
yourself. The elements remain hot for
some time after the end of the
programme.
To open the door with the
emergency release
The emergency release should only
be used when the door cannot be
opened normally, e.g. in the event of
a power failure.
Important note for DESIN
programmes - read the notes in the
Warning and Safety instructions!
Switch the machine off with the I-0
^
button.
To close the door
^
Lift the door upwards and push until
it clicks shut.
14
^
The emergency release cable is
located at the bottom of the machine
behind the service panel. Pull it
downwards to open the door.
Water softener
The water needs to be softened to
avoid calcium deposits building up on
instruments and utensils and in the
machine itself.
To ensure a steady supply of soft water,
the water softener unit must always be:
1. correctly programmed and
2. the salt reservoir must be filled.
If the water hardness level is below
4 °d - German scale (0.7 mmol/l), the
reservoir does not need to be filled
with reactivation salt.
The machine is set at the factory for a
water hardness level of 19 °d
(3.4 mmol/l).
If the water supply is harder or softer
than this (including below 0.7 mmol/l
or 4 °d) the factory setting will need
to be changed following the
instructions in "Setting the water
softener" in the Programming
Manual.
Your local water authority will be able to
advise you on the water hardness in
your area.
For future servicing it is useful to make
a note of your water hardness level.
Enter your water hardness level here:
^
°d (German scale)
or mmol/l
Setting the water softener
See "Operating information Reactivating the water softener" in the
Programming Manual supplied with the
machine.
Salt indicator
Reactivation salt will need to be
replenished when the NO SALT
indicator lights up in the display.
Reactivation takes place automatically
during a programme.
The programme sequence indication
light REACTIVATION lights up whilst this
is happening.
For fluctuating levels e.g. 8 - 17 °d
(1.4 - 3.1 mmol/l) set the water softener
to the highest setting. In this example to
17 °d (3.1 mmol/l).
The built-in water softener has
settings from 1 °d - 60 °d (0.2 -
10.8 mmol/l).
15
Water softener
Filling the salt reservoir
Please only use special coarse grained
reactivation salt with granules of
approx. 1-4 mm. Do not use other types
of salt, e.g. table salt, agricultural or
gritting salt. These could contain
components which are insoluble in wa
ter which could result in damage to the
water softener. If in doubt consult the
Miele Professional Department.
The salt reservoir holds approx. 2.5 kg
of salt.
Inadvertently filling the salt
,
reservoir with cleaning agent will
damage the water softener.
Before filling the salt reservoir make
sure that you have picked up the
right packet of reactivation salt.
^ Remove the bottom basket from the
machine.
-
Place the funnel provided in place.
^
^ Fill carefully with salt.
As it is poured in, displaced water will
run out.
^ Wipe any residual salt off the screw
threads on the socket.
^ Screw the cap on firmly.
^ Unscrew the salt reservoir cap.
Important:
Before filling the salt reservoir with
dishwasher salt for the first time, you
must fill it with approx. 2.5 litres of
water to enable the salt to dissolve.
Once the dishwasher has been
used, there is always sufficient water
in the reservoir.
16
^ Select service programme REMOVE
SALT to flush out any traces of salt
from the cabinet.
If, after switching on the REMOVE
SALT programme, the start is
delayed for a few minutes this is not
a fault. The water softener is being
reactivated.
Automatic mobile unit recognition (AWK)
In operating level C the (optional) AWK
allocates a fixed programme place to a
mobile unit with valid coding.
Programme places 1-15 are reserved
for the AWK automatic mobile unit
recognition.
The unit coding (on the mobile unit)
and the programme place with the
corresponding programme (in the
electronic control unit) have to match
each other.
To do this:
each mobile unit must be coded
^
before being used for the first time
(see "Coding the mobile unit"), and
^ the wash programme through which
the mobile unit is coded has to be
assigned to the relevant programme
place (operating level D, see the
"System function - Selector Switch
Organisation" section in the
Programming Manual).
Mobile unit coding
The automatic mobile unit recognition
feature assigns a programme place to a
mobile unit. The mobile units must be
coded with a magnetic strip (via a Bit
combination).
In operating level C, the only
programme available for a coded
mobile unit is the one assigned to the
corresponding programme place.
After a coded mobile unit has been put
into the machine and the door closed,
the automatic mobile unit recognition
system will select the allocated
programme (as long as there are no
residues or particles on the magnetic
strip). Press 6 to start the programme.
Coding is effected through 5 Bits:
– Bits 1 to 4 define the mobile unit
code,
– Bit 5 serves as a control (Parity Bit).
Important
It is absolutely essential to check
that the programme required for the
mobile unit in use is the one shown
in the display before pressing the
Start button 6.
Otherwise inadequate cleaning or
disinfecting could be the result.
Please make sure that the places
assigned automatic mobile unit
recognition - AWK - are not changed
around arbitrarily.
17
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