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.
en - GB, AU, NZ
M.-Nr. 07 775 960
Contents
Warning and safety instructions .....................................5
This machine complies with all
relevant local and national safety
requirements. Please note that
incorrect use can lead to personal
injury and damage to property.
To avoid the risk of accidents and
damage to the machine, please
read these instructions carefully
before starting to use it. Keep these
instructions in a safe place for
reference, and pass them on to any
future user.
Correct application
This washer-disinfector is designed
~
for use with the applications described
in these Operating Instructions only.
Alterations or conversions to the
machine, or using it for purposes other
than those for which it was designed,
are not permitted and could be
dangerous.
This machine must only be used for
cleaning and disinfecting instruments,
medical devices and laboratory
equipment if the manufacturer has
stated that they are suitable for
machine processing. Manufacturer's
cleaning and maintenance instructions
for instruments etc. must also be
observed.
Miele cannot be held liable for damage
caused by improper or incorrect use or
operation of the machine.
This machine is intended for indoor
~
use only.
This machine is not designed for
~
use in mobile installations unless a risk
assessment of the installation has been
carried out by a suitably qualified
engineer.
Please pay attention to the following
notes to avoid injury and damage.
This machine should be
~
commissioned and then maintained by
a Miele authorised and trained service
technician only. A Miele service
contract is recommended to ensure
compliance with GLP Guidelines and
the Medical Devices Directive.
Unauthorised repairs could be
dangerous, for which the manufacturer
cannot be held liable.
Do not install the machine in an area
~
where there is any danger of explosion
or of freezing conditions.
The electrical safety of this machine
~
can only be guaranteed if connected to
a correctly installed earthing system on
site. It is most important that this basic
safety requirement is present and
regularly tested, and where there is any
doubt the on-site wiring system should
be inspected by a qualified electrician.
The manufacturer cannot be held liable
for damage or injury caused by the lack
of or inadequacy of an effective
earthing system (e.g. electric shock).
A damaged or leaking machine
~
could be dangerous and compromise
your safety. Disconnect the machine
from the mains immediately and call the
Miele Service Department.
5
Warning and safety instructions
Personnel operating the appliance
~
should be trained regularly. Untrained
personnel must not be allowed access
to the machine or its controls.
Take care when handling chemical
~
agents such as cleaning agent,
neutralising agent, rinsing agent etc.
These may contain irritant or corrosive
ingredients.
Please follow the manufacturer's safety
instructions. Wear protective gloves
and goggles. With all chemical agents,
the manufacturer's safety instructions
and safety data sheets must be
observed.
The machine is designed for
~
operation with water and recommended
additive chemical agents only. Organic
solvents and flammable liquid agents
must not be used in this machine.
These could cause an explosion,
damage rubber and plastic
components in the machine, and cause
liquids to leak out of the machine.
The water in the cabinet must not be
~
used as drinking water.
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
vapours.
Where there is a risk of toxic or
~
chemical substances occuring in the
suds solution (e.g. aldehyde in the
disinfecting agent), it is essential to
regularly check door seals and make
sure that the steam condensor is
functioning correctly.
Opening the machine door during a
programme interruption carries
particular risks in such circumstances.
Should personnel accidentally come
~
into contact with toxic vapours or
chemical agents, follow the emergency
instructions given in the manufacturer's
safety data sheets.
Mobile units, modules, inserts and
~
the load must be allowed to cool down
before they are unloaded. Any water
remaining in containers could still be
very hot. Empty them into the wash
cabinet before taking them out.
After using the hot air drying unit,
~
open the door to allow the everything in
the cabinet from the load itself to the
mobile units, modules and inserts to
cool down.
Do not touch the heating elements 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.
6
Warning and safety instructions
Never clean the machine or near
~
vicinity with a water hose or a pressure
washer.
The machine must be disconnected
~
from the mains electricity supply before
any maintenance or repair work is
carried out. Do not reconnect it until the
maintenance or repair work has been
successfully completed.
The following points should be
observed to assist in maintaining
quality standards for processing
medical devices and sensitive
laboratory glassware, and to avoid
injury to patients or damage to
equipment.
If the machine is being used for
~
disinfection in accordance with official
regulations on the control of epidemics,
the steam condenser and its
connections to and from the wash
cabinet must be cleaned and
disinfected whenever any repairs are
carried out or parts replaced.
If it is necessary to interrupt a
~
programme in exceptional
circumstances, this may only be done
by authorised personnel.
The standard of cleaning and
~
disinfection in the disinfection
programmes must be routinely
confirmed by the user. The process
should be validated on a regular basis,
and checked against documented
control results. Chemical disinfection
procedures should also be validated
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.
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 chemical
disinfection procedures is the
responsibility of the operator.
Theatre (OP) shoes should only be
~
cleaned and disinfected in a machine
installed specifically for this purpose.
Only use chemical agents
~
formulated for special processes and
approved by Miele for use with this
machine. Use of unsuitable agents
could adversely affect the components
of the machine. In the event of any
damage or material deterioration
please contact your Miele application
specialist.
Pre-treatments with cleaning or
~
disinfecting agents can create foam, as
can certain types of soiling and
chemical agents. Foam can have an
adverse effect on the disinfection and
cleaning result.
7
Warning and safety instructions
Foam must not be able to escape
~
from the wash cabinet. It would hinder
the correct functioning of the machine.
Check the machine regulary during
~
use to monitor foaming.
To avoid the risk of damage to the
~
machine and any accessories used
with it caused by chemical agents,
soiling and any reaction between the
two please read the notes in "Chemical
Processes and Technology".
Where a chemical agent is
~
recommended on technical application
grounds (e.g. a cleaning agent), this
does not imply that the manufacturer of
the machine accepts liability for the
effect of the chemical on the items
being cleaned.
Please be aware that changes in
formulation, storage conditions etc.
which may not be publicised by the
chemical manufacturer, can have a
negative effect on the cleaning result.
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, baskets 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).
When using cleaning agents and
~
specialised products it is essential that
the manufacturer's instructions are
followed. Chemicals must only be used
for the purpose they are designed for
and in the situation specified, to the
exclusion of other chemicals, to avoid
such dangers as chemical reactions
and material damage.
In critical applications where very
~
stringent requirements have to be met,
it is strongly recommended that all the
relevant factors for the process, such
as chemical agents, water quality etc.
are discussed with the Miele
Application Technology specialists.
8
Ensure that solutions or steam
~
containing hydrochloric acid do not
come into contact with the steel outer
casing of the machine, to avoid any
corrosion damage.
After carrying out any work on the
~
mains water system, the water supply
system to the washer-disinfector must
be vented.
Otherwise, the components in the
machine may become damaged.
Please follow the advice on
~
installation in these instructions and the
separate Installation Instructions.
Warning and safety instructions
Using accessories
Only use genuine Miele original
~
accessories with this machine. Consult
Miele on the type and application of
such equipment.
Only use Miele mobile units, baskets
~
and inserts in this machine. Using
accessories, mobile units and inserts
made by other manufacturers, or
making modifications to Miele
accessories, can result in
unsatisfactory cleaning and disinfecting
results, for which Miele cannot be held
liable. Any resultant damage would also
invalidate the machine guarantee.
Only use chemical agents which
~
have been approved by their
manufacturer for use in the application
you are using. The chemical agent
manufacturer is responsible for any
negative influences on the material the
load is made from and for any damage
they may cause to the machine.
Disposing of your old machine
Please note that the machine may
~
have contamination from blood or other
bodily fluids in it and must be
decontaminated before disposal.
For environmental and safety reasons
ensure the machine is completely
drained of any residual water, chemical
residues and cleaning agent. Observe
safety regulations and wear safety
goggles and gloves.
Make the door lock inoperable, so that
children cannot accidentally shut
themselves in. Then make appropriate
arrangements for its safe disposal.
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.
Symbols on the appliance
Warning:
Observe the operating
instructions.
Warning:
Danger of electric shock.
9
Intended Use
This washer-disinfector can be used to
clean, rinse, disinfect (thermally and
chemically) and dry a wide range of
reusable medical devices and
laboratory equipment.
Follow the manufacturer's instructions
(according to EN ISO 17664) on how to
process their items by machine.
Examples of application areas:
surgical instruments,
–
minimally invasive surgical
–
instruments,
– anaesthetic and intensive care
instruments,
– baby bottles and teats,
– operating theatre shoes,
or
– laboratory equipment used in
research and development,
– laboratory equipment used in areas
of analysis and specimen taking,
–
laboratory equipment used in
micro-biology and biotechnology.
The type of laboratory equipment which
can be processed ranges from
evaporating dishes to centrifugal test
tubes.
Processing medical devices and
laboratory equipment by machine
achieves reproducible results, and
should be used in preference to
processing them by hand.
Where disinfection is required for the
protection of staff and/or patients, a
thermal disinfection programme, e.g.
the DESIN vario TD programme, should
be selected.
The parameters for thermal disinfection
according to EN ISO 15883-1 (A
0
concept) vary depending on the
disinfection standard required. They
are 80 °C (+ 5 °C, - 0 °C) with a 10 min
holding time (A
- 0 °C) with a 5 min holding time (A
600) or 90 °C (+ 5 °C,
0
0
3000). An A0value of 3000 is suitable
for deactivating the HBV virus.
National health and safety regulations
regarding disinfection must also be
observed.
The cleaning programme as well as any
chemical agents must be chosen
according to the type of soiling and
load being processed.
The agents used for processing the
products should be selected to suit the
level of cleaning required as well as the
method of analysis used.
10
The cleaning result must ensure that
instruments can be disinfected
correctly, that no residues are left
behind, that subsequent sterilisation
can be carried out and that the
instruments can be used again safely.
Medical devices are best processed
using the DESIN vario TD programme,
or the ORTHOVARIO or OXIVARIO
programme where applicable.
The use of a suitable carrier (mobile
unit, module, insert etc.) is important to
ensure the adequate cleaning of the
load. Examples are given in the section
"Areas of application".
The washer-disinfector is programmed
to carry out the final rinse with mains
water or with processed water of a
quality to suit the application (e.g. aqua
destillata, purified water, de-ionised
water, demineralised water).
Intended Use
This machine complies with EN ISO
15883 for validation purposes.
11
Guide to the machine
a Electronic controls
b Serial interface, at the back of the
machine (top left behind the cover
panel)
c Test point for validation
d Salt reservoir connection point
(for the water softener)
e Filter combination
f Service panel
12
g Containers for dispensing systems
DOS 2 and DOS 4 (optional)
h DOS drawer
i Reservoir for neutralising agent (red)
and liquid cleaning agent (blue)
j Drying unit (TA)
k Printer (optional)
Controls
Guide to the machine
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.
Faults occurring during operation are shown in the display.
They are listed in a chart in the Programming manual.
b On/Off button (I-0)
c Cursor button: left 1
Moves the cursor to the left:
– to the previous menu point
– to the previous parameter
– to the previous input position
13
Guide to the machine
d Cursor button: right 2
Moves the cursor to the right:
– to the next menu point
– to the next parameter
– to the next input position
e Minus button 3
– Selects programmes from position 24 upwards
– Scrolls back page by page in menus
– Is used for entering numbers and letters
– Alters pre-settings e.g. service parameters
f Plus button 4
– Selects programmes from position 24 upwards
– Scrolls forward page by page in menus
– Is used for entering numbers and letters
– Alters pre-settings e.g. service parameters
g Door switch 5
hStart button 6
– Starts programmes
– Activates input mode
– Confirms activated values and settings
– Confirms menu points for entry into the relevant
sub-menu
14
iStop button 7
– Cancels a programme
– Exits from input screen without saving
– Exits from menu screen
j Service interface 8
kProgramme selector
Selects programme places 1-23
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.
Be especially careful when using
DESIN programmes - read the notes
in the Warning and Safety
instructions carefully.
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 burning or scalding.
^ Switch the machine off with the I-0
button.
To close the door
^
Lift the door upwards and push until
it clicks shut.
^
The emergency release cable is
located at the bottom of the machine
behind the service panel. Pull it
downwards to open the door.
15
Water softener softener (Optional)
In order to achieve good cleaning
results, the washer-disinfector needs to
operate with soft water. Hard water
results in the build-up of calcium
deposits on instruments, etc, and in the
washer-disinfector.
Mains water with a hardness level
higher than 0.7 mmol/l (4° d – German
scale) needs to be softened. This takes
place automatically in the integrated
water softener.
The water softener requires
–
reactivation salt.
The washer-disinfector must be
–
programmed to correspond to the
water hardness in your area.
– Your local water authority will be able
to advise you on the water hardness
in your area.
The water softener is set ex-works for a
hardness level of 3.4 mmol/l or 19°d.
If your water hardness differs from
this (even if it is below 0.7 mmol/l or
4°d) you will need to programme the
level into your machine.
Where the water hardness fluctuates
e.g. between 1.4 - 3.1 mmol/l (8 - 17 °d
German scale) always programme the
washer-disinfector to the higher value
(3.1 mmol/l in this example).
For future servicing it is useful to make
a note of your water hardness level.
Enter your water hardness level here:
°d or mmol/l
Setting the water softener
When the machine is first
commissioned the Miele service
technician has to set the machine for
your local water hardness level (see
Programme manual,
Operation/Reactivation).
Reactivation display
After a certain number of cycles the
message REACTIVATION will appear in
the display to warn you that the water
softener is depleted and cannot supply
any more softened water. As soon as
the programme has finished
reactivation salt will need to be
replenished.
If this cannot be done immediately, and
further cleaning cycles have been
carried out, the reactivation process will
need to be carried out twice in
succession.
The built-in water softener has
settings from 1 °d - 60 °d (0.2 -
10.8 mmol/l).
16
Water softener softener (Optional)
Reactivating the water softener
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
water which could result in damage to
the water softener. If in doubt consult
the Miele Professional Department.
The salt container holds approx. 2 kg of
salt.
If only fine grained reactivation salt
is available please consult the
MIELE Professional Sales office for
advice.
Salt with granules ü 4 mm must not
be used in this machine.
Inadvertently filling the salt
,
reservoir with cleaning agent can
cause serious damage to the water
softener and damage the filter insert,
and cause pressure to build-up in
the salt container. To avoid the risk
of injury please exercise caution
when removing the salt container as
there may be irritant alkaline
solutions present.
Before filling the salt container make
sure that you have picked up the
right packet of reactivation salt.
17
Water softener softener (Optional)
Filling the salt container
^ Unscrew the filter insert from the salt
container and remove.
^ Fill the salt container with reactivation
salt and screw the filter insert back in
place.
Position the salt container as follows
^ Remove any mobile units from the
cabinet.
^ Unscrew the plastic cap situated in
the top right-hand side of the cabinet.
,
There will be a small amount of
residual water in the cap. Take care
as it may be hot from the previous
programme.
18
^
Screw the salt container firmly onto
the socket.
Water softener softener (Optional)
Run the reactivation programme
Close the door.
^
Open the stopcocks.
^
Select the REACTIVATION
^
programme.
The programme will run automatically.
Then:
Switch off the machine.
^
Carefully unscrew the salt container,
^
making sure any water pressure still
remaining can depressurise. Do not
use force!
If the container will not come off
manually please contact the Miele
Service Department.
^ Replace the plastic cap.
^ Push the mobile unit back into the
cabinet.
The water pressure (flow pressure at
the take off point) must be at least
100 kPa (1 bar).
If it is below100 kPa (1 bar) or if it
fluctuates a lot, the water softener
will not work properly. After
reactivation, salt remains may still be
found in the salt container.
To use up salt remains and to rinse
out the water softener, the
REACTIVATION programme must be
carried out again.
^ Turn off the stopcocks.
^ Empty the salt container. Do not
empty it into the wash cabinet.
^
Rinse the salt container and filter
insert with clean water.
19
Automatic mobile unit recognition (AWK)
In operating level C the automatic
Before starting a programme it is
mobile unit recognition system (AWK)
allocates programme places from 1 15 to mobile units with the correct
coding.
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 programme for which the mobile
unit is coded must be allocated to the
correct programme place.
See "System function - Selector switch
organisation" in the Programming
manual for information on how to
change programme positions.
,
absolutely essential that you 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.
20
Automatic mobile unit recognition (AWK)
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).
,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 incorrectly
read.
Coding is effected through 5 Bits:
Bits 1 to 4 define the mobile unit
–
code,
– Bit 5 serves as a control (Parity Bit).
Press 6 to start the programme.
21
Automatic mobile unit recognition (AWK)
Mobile unit coding strip
15 different codes can be set. They are
assigned to programme places 1 to 15.
Under "System function, Selector switch
organisation" the matching
programmes have to be put into the
first 15 programme places.
Programme
place
10
11
12
13
14
15
Bit 1 Bit 2Bit 3Bit 4Bit 5
0
1
2
3
4
5
6
7
8
9
0
0
I
I
0
I
I
0
0
0
I
I
0
I
I
0
0
0
I
I
0
I
I
0
0
0
I
I
0
I
I
Parity
Bit
0
0
0
0
0
0
I
I
I
I
0
0
0
0
I
I
I
I
I
0
I
0
0
0
I
0
0
0
0
0
I
0
I
I
0
I
0
I
I
I
0
I
I
I
I
I
0
I
Setting mobile unit coding
To set or alter the coding of a mobile
unit with automatic recognition (AWK),
proceed as follows:
^ Unscrew the track with AWK (using
an allen key) and remove from the
retainer.
The coded total must be an even
number.
If the coded total gives an odd number
the message CHECK MOBILE UNIT
RECOGNITION appears.
If the mobile unit total equals 0, the
message NO MOBILE UNIT
RECOGNITION will appear. In neither
case can the programme be started,
and the mobile unit recognition function
will have to be re-set.
22
^
Remove the magnetic strip from the
track.
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