Miele PG 8536 User manual

Operating instructions
Washer-disinfector
PG 8536
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. M.-Nr. 10 317 371
en - GB, AU, NZ

Warning and safety instructions .....................................5
Correct application ...............................................5
Symbols on the appliance .........................................9
Intended Use ....................................................10
User profile ......................................................11
Description of the machine.........................................12
Controls .........................................................13
Display ..........................................................15
An example of a selected list ......................................15
An example of a programme sequence display .......................16
Context menu ....................................................17
Change display language ...........................................18
Changing operating level ...........................................19
Delay start .......................................................21
Current faults .....................................................23
Reactivation ......................................................23
Opening and closing the door ......................................24
Electric door lock ..................................................24
To open the door with the emergency release ...........................24
Water softener ...................................................25
Setting the water softener ...........................................25
Reactivation display................................................25
Reactivating the water softener .......................................26
Filling the salt container ..........................................26
Position the salt container as follows ................................26
Run the reactivation programme ...................................27
Automatic mobile unit recognition...................................28
Spray arm monitoring .............................................29
Areas of application...............................................30
Protein test .......................................................30
Loading the machine ...............................................31
Water connection spring adapter .....................................32
Height adjustable top basket.........................................32
Surgical instruments (OP) ...........................................33
Ophthalmology ...................................................34
Anaesthetic instruments (AN) ........................................35
Baby bottles (BC) .................................................36
Contents
2

Operating theatre shoes ............................................37
Laboratory glassware (LG) ..........................................38
Chemical processes and technology.................................40
Dispensing liquid chemical agents ..................................45
Dispensing systems................................................46
"Fill DOX [X] container" message ...................................46
Fill the containers with the relevant agent ............................47
"Check dispensing system [X]".....................................48
Venting the dispensing system.....................................48
Operation .......................................................49
Switching on .....................................................49
Reset button ...................................................49
Starting the programme.............................................49
Programme sequence ..............................................50
At the end of the programme.........................................50
Switching off .....................................................50
Cancelling a programme ............................................51
Interrupting a programme ...........................................52
Process documentation ...........................................53
Maintenance .....................................................54
Periodic checks ...................................................54
Process validation .................................................54
Routine checks ...................................................54
Cleaning the filters in the wash cabinet.................................55
Cleaning the coarse filter .........................................55
Cleaning the coarse, flat and micro-fine filters .........................56
Cleaning the spray arms ............................................57
Cleaning the control panel...........................................58
Cleaning the front of the machine .....................................58
Cleaning the wash cabinet ..........................................58
Cleaning the door seals.............................................58
Mobile units, baskets and inserts .....................................59
Drying unit (TA) - Maintenance .......................................60
Changing the coarse filter ........................................60
Changing the fine filter ...........................................61
Contents
3

Problem solving .................................................62
Thermal cut-out ...................................................62
Cleaning the filters in the water inlet ...................................63
After sales service ................................................64
Installation ......................................................65
Electrical connection..............................................66
Plumbing........................................................67
Connection to the water inlet .........................................67
AD water connection (pressurised) ö60 - 1000 kPa over pressure ........68
Optional AD water connection (without pressure) 8.5 - 60 kPa ............68
IMPORTANT
Australia and New Zealand ..........................................69
Drainage ........................................................70
Technical data ...................................................71
Optional extras...................................................72
Special processes - OXIVARIO and ORTHOVARIO .....................73
Intended use .....................................................73
Areas of application .............................................73
Warning and Safety instructions ......................................74
Connecting the H2O2solution container ................................74
Disposal of your old machine.......................................75
Contents
4

This washer-disinfector 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 washer-disinfector,
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 washer-disinfector 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 reprocessing.
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 washer-disinfector is intended
for stationary, indoor use only.
Please pay attention to the following
notes to avoid injury and damage.
~This washer-disinfector 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 Device Directive.
Unauthorised repairs could be
dangerous and jeopordise the personal
safety of the operator.
~Do not install the washer-disinfector
in an area where there is any danger of
explosion or of freezing conditions.
~The electrical safety of this
washer-disinfector can only be
guaranteed when correctly earthed. It is
most important that this basic safety
requirement is observed 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
washer-disinfector could be dangerous
and compromise your safety.
Disconnect the machine from the mains
immediately and call the Miele Service
Department.
~Personnel operating the machine
should be trained regularly. Untrained
personnel and children must not be
allowed access to the machine or its
controls.
Warning and safety instructions
5

~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 washer-disinfector 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.
~Please be aware that the
washer-disinfector may be operating at
high temperatures. If the door is
opened with the emergency release
cord, there is a danger or burning,
scalding or chemical burning or if
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 condenser 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 unloading the machine. 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 if
you open the door directly after the end
of a programme; you could burn
yourself. They remain hot for some time
after the end of the programme.
Warning and safety instructions
6

~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 reprocessing
medical devices and sensitive
laboratory glassware, and to avoid
injury to patients or damage to
equipment.
~If the washer-disinfector 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 for medical devices must
be routinely confirmed by the user. The
process must be validated on a regular
basis, and checked against
documented control results. Chemical
disinfecting procedures must 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 devices should be
reprocessed by thermal disinfection.
Items which are not heat-resistant, e.g.
operating theatre (OP) shoes, should
be cleaned with the CHEM-DISIN
programme with the addition of a
chemical disinfection agent.
The range of effective disinfection is
based on claims made by the producer
of the disinfecting agent, whose advice
regarding handling, use and
effectiveness must be observed. This
type of chemo-thermal procedure is not
suitable for reprocessing medical
devices.
~Chemical agents could, under
certain conditions, cause damage to
the washer-disinfector. Follow the
recommendations of the chemical
agent manufacturer. In the event of any
damage or material deterioration
please contact Miele.
~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.
~Foam must not be able to escape
from the wash cabinet. It would hinder
the correct functioning of the machine.
~The process used should be
checked regularly by the supervisor to
monitor foaming levels.
Warning and safety instructions
7

~To avoid the risk of damage to the
washer-disinfector 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.
~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 Miele.
~If cleaning and rinsing results are
subject to particularly stringent
requirements (e.g. chemical analysis),
a regular quality control test must be
carried out by the supervisor 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.
~The amount of residual solvents and
acids on items going into the cabinet
should be minimal. This applies in
particular to hydrochloric acid or
chloride solutions and to items
containing iron that can rust or corrode.
The presence in soiling 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.
~After carrying out any work on the
mains water system, the water supply
system to the washer-disinfector must
be vented.
Otherwise, components in the machine
may become damaged.
Warning and safety instructions
8

~In areas which may be subject to
infestation by cockroaches or other
vermin, pay particular attention to
keeping the appliance and its
surroundings in a clean condition at all
times. Any damage which may be
caused by cockroaches or other vermin
will not be covered by the guarantee.
~Please follow the advice on
installation in these instructions and the
separate Installation Instructions.
Using accessories
~Only use genuine Miele original
accessories with this washer-disinfector
and only use them for the purposes
they are designed for. Consult Miele on
the type and application of such
equipment.
~Only use Miele mobile units, baskets
and inserts in this machine. Using
mobile units, baskets 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.
Symbols on the appliance
Warning:
Observe the operating
instructions.
Warning:
Danger of electric shock.
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.
Warning and safety instructions
9

Re-usable medical devices, laboratory
equipment and accessories can be
cleaned, rinsed, disinfected and dried
in this Miele washer-disinfector.
Follow the medical device and
laboratory equipment manufacturer's
instructions (according to EN ISO
17664) and local and national
regulations and guidelines, on how to
reprocess 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 reprocessed ranges from
evaporating dishes to centrifugal test
tubes.
Reprocessing medical devices and
laboratory equipment by machine
achieves reproducible results, and
should be used in preference to
reprocessing them by hand.
Where disinfection is required for the
protection of staff and/or patients, carry
out thermal disinfection using e.g. the
DESIN vario TD programme.
- Except for operating theatre (OP)
shoes which are not heat-resistant, for
which the CHEM-DISIN programme
should be used.
The parameters for thermal disinfection
according to EN ISO 15883-1 (A0
concept) vary depending on the
disinfection standard required. They
are 80 °C (+ 5 °C, - 0 °C) with a 10 min
holding time (A0600) or 90 °C (+ 5 °C,
- 0 °C) with a 5 min holding time (A0
3000). An A0value of 3000 is suitable
for deactivating the HBV virus.
National health and safety regulations
regarding disinfection must also be
observed (CfPP 01-01, Part D and
Harmonised EU Norm EN 15883-2 in
the UK).
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 reprocessing the
products should be selected to suit the
level of cleaning required as well as the
method of analysis used.
Intended Use
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 reprocessed
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). The water
quality is of particular importance for
applications requiring analytically clean
laboratory glassware.
This washer-disinfector complies with
EN ISO 15883 for validation purposes.
User profile
Daily operatives
Operatives using the machine daily
should be familiar with the basic
functions of the machine and its loads
and trained on a regular basis. They
require basic knowledge about how to
reprocess medical devices by
machine.
Generally they would be using the
machine in Operating levels A and C.
Supervisory level
More advanced functions such as
interrupting or cancelling a programme
requires more in-depth knowledge
about machine reprocessing of medical
devices.
This level of functionality is carried out
in Operating level B.
Service and Administration
Changes to processing methods and
alterations to the washer-disinfector,
e.g. concerning the type of accessories
used in it or the conditions in which the
machine is used requires additional
knowledge about the machine.
Validation also requires additional
knowledge about how to reprocess
medical devices, which procedure to
use and any Standards and regulations
that may apply.
Service and validation work is carried
out using Operating level D.
Intended Use
11

aElectronic controls
bSerial interface,
at the back of the machine
(top left behind the cover panel)
cWater inlet
dTest point for validation
eSalt reservoir connection point
(for the water softener)
fFilter combination
gService panel
hContainers for dispensing systems
DOS 2 and DOS 4 (optional)
iDOS drawer
jReservoir for neutralising agent (red)
and liquid cleaning agent (blue)
kDrying unit (TA)
lReset button
Description of the machine
12

Controls
aOn/Off button s
For switching the machine on and off
bDoor button a
cDisplay
The display will switch off automatically after approximately
10 minutes when the washer-disinfector is not in operation.
Press any button to switch the display back on again.
Faults occurring during operation will be indicated by a
number in the display.
The fault numbers are listed in the Programming manual.
Description of the machine
13

dPC service interface 9
For testing and updating the programme data
ehStart button
For starting the programme
f+C (Clear) button used to
– return to the previous level
– delete entries already made
– to cancel a programme
gand i- e buttons (Selector buttons) used to
– move the highlighting in the display
– change highlighted values
– scroll
– call up context menus
– show user defined operating parameters during the
programme
hOK button
– confirm highlighted options or selected values
– acknowledge error messages
– acknowledge dialogue messages
– call up the A0graph during a programme.
– view the temperature graph during a programme.
Description of the machine
14

Display
The display can show the following, depending on the
operating level:
–the programme / programme overview
–the programming menu
–the Settings Jmenu
The Settings menu Jis used to alter the
washer-disinfector's profitronic controls to suit different
requirements. See the Programming manual for more
details.
An example of a selected list
Programme overview B
REACTIVATION
DES-VAR-TD
DES-VAR-TD-AN #
The - e buttons are used to select the options.
The selector buttons -e move the highlighting in the display.
The OK button is used to confirm a message or setting and
also to move to the next menu or to another menu level.
To select an option use the selector buttons -e to highlight it
and then confirm your selection with the OK button.
The display shows a maximum of three options or choices. A
scroll bar on the right hand side of the display indicates that
more options or choices are available. The -e selector
buttons are used to display these.
The end of the list is marked with a dotted line. The last entry
in the list is shown above the line and the first, below it.
Description of the machine
15

An example of a programme sequence display
DES-VAR-TD A
Main wash 55,2 °C
Time remaining 0:35 h
During a programme, the display shows the following:
–the name of the programme
–the operating level
–the programme block
–the water temperature
(the air temperature in the "Drying" programme block)
– the estimated programme duration remaining or the
programme duration already elapsed
– any relevant error messages and notes.
Description of the machine
16

Some functions can be called up at any time via a context
menu, irrespective of the operating level:
–Change display language,
–Change operating level,
–Enter delay start,
In addition, no current fault messages will be displayed in
operating level D (if applicable).
^Press the - e buttons at the same time for at least 3
seconds to call up the context menu.
The context menu will appear in the display:
Context menu B
Change display language F
Change operating level
Delay start #
The - e buttons are used to select the options.
Context menu
17

Change display language
You can change the language in which the display is
currently being shown via the context menu.
This setting will remain active until the washer-extractor is
switched off with the sbutton.
N.B. The language set in the Settings / Language Jmenu
will not be changed and all reports and print-outs will
continue to be printed in this "Settings" language.
^Select the Change display language option with - e and
activate your selection with OK.
The flag Jafter the words Change display language acts
as a guide if a language which you do not understand has
already been set.
If this is the case, keep changing the options until the flag
Jappears.
^Select the language you require and confirm your selection
with OK.
The language selected will be shown in the display.
^Press +Cto come out of the context menu.
Context menu
18

Changing operating level
There are four operating levels available on this
washer-disinfector:
Operating level Access authorisation for
A and B Selection from a list of specified
programmes.
C Automatic programme selection via mobile
unit coding.
D Free programme selection in the
Programme overview, Programming and
Settings J.
You can switch between the operating levels via the context
menu.
To prevent unauthorised access to the settings, you will be
asked for a code when changing to another operating level.
You must be signed on as the administrator, to be able to
change the codes of the various operators or to install new
operators. The Administrator operator is set by a Miele
Service technician.
^Press the - e buttons at the same time for at least 3
seconds.
The context menu will appear in the display:
Context menu B
Change display language F
Change operating level
Delay start #
Context menu
19

^Select the Change operating level option and call up the
sub-menu with OK.
Select operator B
Operator ABC
Administrator
Miele Service
^Select the user group you require and confirm with OK.
^Enter the requested code.
Change operating level B
0F F F
Enter code
The - e buttons alter the values, the OK button confirms the
values entered and moves on to the next input position.
The electronics will change to the operating level selected.
^Press +Cto come out of the context menu.
Code invalid will appear if you make a wrong entry.
^Acknowledge the fault message with OK.
The Change operating level process will begin again.
Context menu
20