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.
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 chemothermally 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.
Areas of application:
surgical instruments,
–
minimally invasive instruments which
–
can be processed shortly after use,
anaesthetic and intensive care
–
instruments,
baby bottles and teats,
–
stainless steel and aluminium
–
containers (including anodised
aluminium),
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.
4
Description of the machine
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 reprocessed using the
DESIN vario TD programme, or the
OXIVARIO programme 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.
If the mains water hardness level is
more than 70 mg/l (4°d), a water
softening system should be provided
on-site, such as the Miele G 7897
"Aqua-Soft system" which is effective up
to approx 720 mg/l (40°d).
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
Unclean side
a Hot air drying unit TA *)
b Steam condenser DK *)
*) behind top housing (optional)
c "Profitronic" electronic controls (see
also "Programming manual")
d Controls
8
e Master switch (with "emergency
cut-off function" for service work)
f Lift door (closed)
g Docking facility for the "Mieltransfer"
trolley.
h Service panel
Unclean side
Guide to the machine
a Lift door (open)
b Filter combination
c Containers for dispensing systems
DOS 1 - DOS 4
9
Guide to the machine
Clean side (G 7828 only )
a Door release
b Lift door (closed)
c Printer (optional)
G 7827: on the unclean side
10
d Service panel with docking facility for
the "Mieltransfer" trolley.
Warning and safety instructions
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
This washer-disinfector is designed
for commercial use and 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, aircraft etc. if 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.
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.
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 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).
11
Warning and safety instructions
A damaged machine is a safety
hazard. Switch off at the mains
immediately and call the Miele Service
Department or an authorised and
trained Miele Service 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.
Take care when handling
chemicals 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.
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 everything
in the cabinet from the load itself to the
mobile units, modules and inserts to
cool down.
Do not touch the heating elements
(under the wide area filter) 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.
If the boiler has been programmed
to "BOILER READY", be particularly
careful of hot water and steam when
opening the door. Danger of burning or
scalding. The inlet to the wash cabinet
is located, as viewed from the unclean
side, underneath the basket runner on
the left hand side.
Steam heating is permissible up to
a pressure of 1000 kPa (10 bar).
This corresponds to a water steam
temperature of 179 °C.
12
Never clean the machine or near
vicinity with a water hose or a high
pressure hose.
Warning and safety instructions
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 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.
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, chemical or
bio-indicators, and this 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 chemothermal 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.
13
Warning and safety instructions
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. Any resultant damage
would invalidate the machine
guarantee.
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. Only use the product for the
application described by the
manufacturer, to avoid any material
damage or the occurrence of strong
chemical reactions.
The machine is designed for
operation with water and 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.
14
Warning and safety instructions
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.
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, chemical
residues and cleaning agent. Observe
safety regulations and wear safety
goggles and gloves.
Make the door lock inoperable, and
block or disable the door in such a way
that children cannot accidentally shut
themselves in the cabinet. 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 before it is
moved.
The manufacturer cannot be held
liable for damage caused by
non-compliance with these Warning
and Safety instructions.
15
Opening and closing the lift door
The lift door can only be opened when:
the electricity supply to the machine
–
is switched on,
the red ("emergency cut out") master
–
switch is in the I-ON position,
the I-0 On-Off button is pressed in
–
and
a cleaning or disinfection programme
–
is not in progress.
The door on the clean side (G 7828)
can only be opened if:
– DESIN (disinfection) programmes
have been correctly completed,
or
– if the Door interlock has been
activated, i.e. DOOR MECH. has
been set to one of the following
parameters:
- INTERLOCK,
- DOOR CLEAN+INTERLOCK,
- DOOR UNCL.+INT.LOCK.
(see "Machine function - Door
mechanism" in the programming
manual).
To open the lift door
Press the 5 door button. The lift door
^
rises.
Do not touch the heating
,
elements under the wide area filter
during or directly after the end of a
programme. You could burn
yourself. They remain hot for some
time after the programme has
finished.
If the boiler has been programmed
to "BOILER READY", be particularly
careful of hot water and steam when
opening the door. Danger of burning
or scalding. The inlet to the wash
cabinet is located, as viewed from
the unclean side, underneath the
basket runner on the left hand side.
To close the lift door
^ Press the 5 door button. The lift door
lowers itself.
16
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