Miele PG 8528 User manual

Installation and operating instructions
Washer-Disinfector
PG 8527 / PG 8528
To avoid the risk of personal injury or
damage to the appliance,
it is essential that
you read these operating instructions
before installation and use. M.-Nr. 07 167 510
en-CA

Important safety instructions ........................................4
Proper use .....................................................4
Using accessories ...............................................8
Symbols on the appliance .........................................8
Disposing of an old appliance ......................................8
Description of the machine..........................................9
Guide to the appliance ............................................11
Electronic controls .................................................14
How the display works..............................................16
Example for a selection list ........................................16
Example for a program sequence display ............................17
Context menu ....................................................18
Change the display language ........................................19
Change the operating level ..........................................20
Delay start .......................................................22
Change the heating type ............................................24
Current Faults ....................................................24
Automatic mobile unit recognition...................................25
Application ......................................................26
How to load the machine ............................................27
OR Instruments (OP) ...............................................28
Anesthesia instruments (AN) .........................................29
Baby bottles (BC) .................................................30
OR shoes (OS)....................................................31
Laboratory equipment (LG) ..........................................32
Adding liquid detergents and neutralizers ............................33
Dispensing systems................................................35
Message "Fill DOS [X] container" ...................................35
Adding liquid detergents and neutralizers ............................35
Message "Check dispensing system [X]" .............................36
Priming the dispensing system.....................................36
Operating the machine ............................................37
Main switch ......................................................37
How to switch on ..................................................37
How to start a program .............................................38
Contents
2

Program sequence ................................................40
End of program ...................................................40
How to switch off ..................................................40
Cancelling a program ..............................................40
Interrupting a program..............................................41
Barcode scanner (optional) ........................................42
Data transfer.....................................................43
Maintenance .....................................................44
Periodic checks ...................................................44
Process validation .................................................45
Routine checks ...................................................45
Cleaning the filters in the wash cabinet.................................46
Cleaning the fine filter ............................................46
Cleaning the flat filter ............................................46
Cleaning the filter system for the circulation pump .....................47
Cleaning the spray arms ............................................48
Cleaning the control panel and glass door (Optional) .....................49
Cleaning the front of the appliance ....................................49
Cleaning the wash cabinet ..........................................49
Cleaning the door seal..............................................49
Mobile units, baskets and inserts .....................................50
Built-in printer (Option) .............................................51
Replacing the paper roll ..........................................51
Replacing the ribbon cartridge.....................................51
Customer service.................................................52
Electrical connection..............................................53
Plumbing........................................................54
Technical data ...................................................56
Optional equipment ...............................................57
Special options - OXIVARIO and ORTHOVARIO........................58
Description of the machine ..........................................58
Applications ...................................................59
Important safety instructions .........................................60
Connecting the H2O2container(s) .....................................60
Disposing of an old appliance ......................................61
Contents
3

This appliance complies with all
applicable safety laws and
regulations. However, inappropriate
use can result in personal injury and
property damage.
Read the operating instructions
carefully before using this machine.
This will help keep you safe and
avoid damage to the machine.
Keep these instructions in a safe,
accessible location.
Proper use
~This washer-disinfector is not
intended for any purpose that is not
indicated in the operating instructions.
Any other use, including conversions or
modifications, are not permitted and
can be dangerous.
The cleaning and disinfection
processes described here apply only to
those instruments, medical products
and labware that are specifically
designed by the manufacturer to be
re-used. Always comply with the
manufacturer's instructions.
Miele will not be held liable for damage
caused by incorrect use of any kind.
~This machine is intended exclusively
for use in interior locations.
~The appliance is not designed for
use in non-stationary locations (for
example, on ships). However, this use
may be possible if a qualified specialist
determines that the appliance can be
used safely in the location in question.
To avoid injury, please follow these
instructions!
~This machine should only be
installed, maintained and repaired by a
Miele-authorized service technician. For
best compliance with Good Laboratory
Practice and regulations governing the
use of medical products, a valid Miele
service and repair contract is
recommended. Work performed by
unqualified persons can place the user
at considerable risk of harm.
~Do NOT install the
washer-disinfector in an area where
there may be the danger of explosion
or freezing.
~The electrical safety of this
appliance can be ensured only when it
has been properly grounded in
compliance with applicable safety
regulations. It is imperative that this
basic safety requirement be met. In
case of any doubt, have the electrical
system checked by a qualified
technician.
The manufacturer will not be held liable
for damages resulting from an
inadequate grounding system (e.g.,
electric shock).
~A damaged appliance can
endanger your safety. Immediately turn
off the machine at the power switch and
contact the Miele Service Department.
~Machine operators must be trained
on a regular basis. Untrained personnel
must not be allowed access to the
machine or its controls.
Important safety instructions
4

~Always exercise caution when
handling the processing chemicals for
this machine (detergent, neutralizer,
saponifier, rinsing agent, etc.). Some of
these products contain corrosive and
irritating substances. NEVER use
organic solvents or flammable liquids
because of the risk of explosion.
Always follow proper safety technique.
Use protective glasses and gloves.
Always follow the manufacturer's safety
recommendations when using process
chemicals (see material safety data
sheets).
~The water in the wash cabinet is
NOT safe to drink.
~Take care when sorting items with
sharp pointed ends. Position them in
the machine so that you will not hurt
yourself or create a danger for others.
~When operating this machine,
beware of the high temperatures
involved. If you bypass the electrical
lock to open the door, there is the
danger of scalding and heat or
chemical burns. If disinfectants have
been used, there is also the danger of
inhaling toxic vapour.
~If you are exposed to toxic vapours
or processing chemicals, consult the
manufacturer's material safety data
sheets for emergency procedures.
~Always allow mobile units, modules,
inserts and loads to cool before
removing. Be sure to empty any water
from concave items into the wash
cabinet before removing.
~After drying with the drying unit,
leave the door open at first, to allow the
items and inserts to cool down.
~If the pre-heater has been
programmed to "Pre-heater standby",
be particularly aware of hot water and
steam when opening the door! Danger
of burning or scalding. The water inlet
pipe to the wash cabinet is located, as
viewed from the loading side,
underneath the basket runner on the
left hand side.
~Steam heating is permissible up to a
pressure of 145 psi (1000 kPa) (10 bar).
This corresponds to a water steam
temperature of 179°C (354°F).
~NEVER hose down the
washer-disinfector or the immediate
vicinity, e.g., with a water hose or
pressure washer.
~Before servicing the
washer-disinfector, disconnect it from
the power supply.
,Mount on non-combustible floors
only!
Important safety instructions
5

The following points should be
observed to assist in maintaining
quality standards when processing
medical devices and critical labware,
to protect patients and to avoid
damage to property!
~If the machine is being used for
disinfection ordered by the authorities,
the steam condenser and its
connections to the rinsing chamber and
outlet discharge must be disinfected
before any repair or exchange.
~Only authorized persons may
interrupt a program and only in
exceptional cases.
~It is the responsibility of the operator
to routinely check that the required
cleaning and disinfection standards are
being met. Therefore, process results
need to be regularly tested and
documented, both thermoelectrically
and through inspection. For
thermochemical processes, additional
testing is required using chemical or
biological indicators.
~For thermal disinfection, the
appropriate temperatures and holding
times, as required by microbiological
and public health standards and
guidelines, must be used to achieve the
required degree of infection control.
~Disinfection programs that use a
chemical disinfectant at moderate
temperatures (for example 65 °C or
below) do NOT fulfill the requirement for
mandatory disinfection under §18 of the
IfSG. Such programs should only be
used when the items in question are
temperature-sensitive. The disinfection
parameters are based on the expertise
of the disinfectant manufacturer.
Always note their specifications for
handling, applications and efficacy.
The operator is responsible for the use
of any such thermochemical processes.
~If toxic chemicals may be present in
the wash cabinet, (e. g. aldehydes in
the disinfectant), beware of this risk
when interrupting a program and
opening the washer-disinfector. The
door seal and steam condensor must
always be checked for soundness.
~OR shoes should only be cleaned
and disinfected in a washer-disinfector
that has been installed for that purpose.
~Under certain circumstances, the
processing chemicals can cause
damage to the appliance. Consult Miele
Customer Service for
recommendations. For concerns
involving possible damage to the
appliance or materials, please consult a
Miele Application Specialist.
~Pre-treating (e. g. with cleaning
agents or disinfectants), some types of
soiling and the interaction of certain
processing chemicals can cause
foaming. Suds can have an adverse
effect on the results obtained.
Important safety instructions
6

~Even when a chemical additive is
recommended, the appliance
manufacturer takes no responsibility for
the effect of such chemicals on the
labware involved.
Note that formulation changes, storage
conditions, etc., that are not disclosed
by the manufacturer may adversely
affect the cleaning results obtained.
~When using additives and special
products, always follow the
manufacturer's instructions. To avoid
material damage and the possibility of
violent chemical reactions (e.g.
hydrogen gas reaction), always comply
with the manufacturer's intended
application(s) for a given cleaning
agent.
~The washer-disinfector is only
designed for use with water and
recommended processing chemicals.
Organic solvents must NOT be used,
as there is the danger of explosion
and/or damage. (Note: while certain
organic solvents do not carry a risk of
explosion, they may nonetheless cause
other problems, such as damage to
rubber and synthetic parts.)
~For critical applications, where very
high processing requirements have to
be met, it is strongly recommended that
all process-related factors (processing
chemicals, water quality, etc.) be
discussed in advance with a Miele
Application Specialist.
~In addition, for applications that
demand especially stringent cleaning
and rinsing results, (e.g., chemical
analysis, special industrial processes,
etc.) the operator must ensure that
quality control occurs on a regular
basis, to meet the standard of
preparation required.
~Only use mobile units, modules and
inserts as intended by the
manufacturer.
Hollow items must be positioned for full
exposure to wash water.
~Empty all containers and hollow
utensils before loading them.
~Ensure that no acid or solvent
residues, especially hydrochloric acid
or chloride solutions, get inside the
wash cabinet. Never place corroding
iron items in the washer-disinfector.
Only trace amounts of any organic
solvents should be present in any
soiling (especially for solvents in hazard
class A1).
~To avoid corrosive damage, make
sure the stainless steel housing does
not come into contact with
solutions/steam containing hydrochloric
acid.
~Please be sure to follow the
installation instructions in this manual
and in the installation manual.
Important safety instructions
7

Using accessories
~Whatever the application, only Miele
accessories should be connected to
this machine. Consult a Miele
Application Specialist for details on the
type of equipment to use.
~Only Miele mobile units, modules
and inserts should be used. If Miele
accessories are altered in any way, or
equipment from another manufacturer
is used, Miele cannot ensure the
cleaning and disinfection results.
Damage or injury caused in this way
are excluded from the warranty.
~Only use process chemicals that are
approved by their manufacturer for the
application involved. Any negative
effects on labware and the
washer-disinfector itself are the liability
of the chemical manufacturer.
Symbols on the appliance
Attention:
Comply with the Operating
Instructions!
Attention:
Danger of electric shock!
Disposing of an old appliance
~Any old appliance may be
contaminated from exposure to
pathogens, genetically modified
material, blood, etc., and therefore
must be decontaminated before
disposal.
For safety and environmental
protection, be sure to drain/remove all
process chemical residue. (Comply
with safety regulations and wear
protective eyewear and gloves.)
Remove or inactivate the door latch, to
prevent children from locking
themselves inside. The appliance can
now be sent for disposal through the
proper resource recovery facilities. For
machines with a tank system, be sure
to drain the water from the tank before
disposal.
The manufacturer will not be held
liable for damage caused by failure
to comply with these safety
instructions and warnings.
Important safety instructions
8

Miele washer-disinfectors are designed
to clean, rinse, disinfect
(thermal/thermochemical) and dry
re-usable medical devices, laboratory
equipment and instrumentation.
Whatever items are being processed,
always comply with the particular
manufacturer's instructions (EN ISO
17664).
Typical applications include:
–surgical instruments,
–endoscopic instruments,
– intensive care and anesthesiology
equipment,
– baby bottles and nipples,
– supply and disposal containers,
– OR shoes,
or
– laboratory equipment for research
and production,
–laboratory equipment for analytical
and preparation applications,
–microbiology and biotechnology
labware.
Labware can include anything from
evaporation dishes to centrifuge tubes.
In this operating manual, the general
term labware is used to cover a range
of equipment and items.
For standardized results, it is preferable
to machine-wash lab instruments and
equipment.
When disinfection is required to protect
staff and/or patients, the preference is
for thermal disinfection, e. g., with the
DESIN vario TD process.
According to the A0concept described
in EN ISO 15883-1, thermal disinfection
occurs at 80°C (+ 5 °C, - 0 °C) with
10 min holding time (A0600), or at 90°C
(+ 5 °C, - 0 °C) with 5 min holding time
(A03000), depending on the
disinfection result required. The
efficacy standard A03000 includes the
inactivation of HBV.
Regional and/or other official directives
may apply (e. g., §18 of the IfSG for
Germany).
The cleaning parameters should always
be optimally matched to the type of
soiling and labware involved.
The processing chemicals used also
should be matched to the particular
cleaning needs / analysis / analytical
methods involved.
Description of the machine
9

For re-usable items to be safe for
continued use, the cleaning result must
meet certain minimum standards for
disinfection, sterilization and residue
levels.
Re-usable medical products are best
cleaned with the DESIN vario TD
process or, as appropriate, with the
ORTHOVARIO or OXIVARIO processes.
Also important for acceptable cleaning
results is the use of suitable loading
accessories (mobile carts, modules,
inserts). See the section on
"Applications" for examples.
The washer-disinfector is designed to
rinse with tap water or processed water
(e.g., distilled water, pure water,
deionized water, demineralized water)
depending on the quality required for
your application(s). The water quality
selected is especially important for
labware intended for analytical uses.
Under EN ISO 15883, this
washer-disinfector is suitable for
process validation.
Description of the machine
10

Unclean side
aHousing unit for Drying unit TA
and/or Steam Condenser DK
b"Profitronic" electronic control system
(also see "Programming manual")
cMultiport
dMain switch "ON/OFF"
eBarcode scanner mount (optional)
fService panel
gDocking station for transfer cart MF
27/28
hLift door (closed)
Guide to the appliance
11

Unclean side
aLift door (open)
bConnection for transfer cart and
modules
cLower spray arm
dFilter combination
eContainer for dispensing systems
DOS 1 - DOS 4
Guide to the appliance
12

Clean side (only PG 8528)
aLift door (closed)
bService panel with docking station
for transfer cart MF 27/28
cMultiport
dBarcode scanner mount (optional)
ePrinter (optional)
f"Door" button
gDisplay
Guide to the appliance
13

Electronic controls
aButton s(ON/OFF)
Turn washer-disinfector on and off
bButton a(Door opener)
Open and close the door
cDisplay
If the washer-disinfector is not in use, the display
automatically switches off after approx. 10 min.
To turn the display back on, touch any button.
Fault messages are shown in the display, together with a
corresponding number.
See the "Programming manual" for more information.
Guide to the appliance
14

dOptical Interface 9
Used by Miele Service Technicians
eButton h(Start button)
Start the program
fButton +C (Clear button)
– return to the previous level
– discard entry
– cancel program
gand iButtons -e(Selection buttons)
– shift position of marking in display
– change marked value
– scroll
– retrieve context menu
– display user-defined operating parameter during
program operation
hOK Button
- confirm marked menu item or selected value,
- erase fault messages,
- erase dialogue messages,
- access A0graph during program operation.
Guide to the appliance
15

How the display works
Depending on the operating level, the following choices are
available in the display:
–a program / the program overview
–the programming menu
–the settings menu J
In the menu Settings J, you can adjust the Profitronic
control system to suit various requirements. For additional
information, please see the "Programming manual".
Example for a selection list
Main menu B
CHANGE TA-COARSE
DIS-VAR-TD
DIS-VAR-TD-IN #
Use the buttons -eto move through the menu items.
The marking in the display can be moved using the buttons
-e.
Use the OK button to confirm messages or settings and
change to the next menu or another menu level.
To select a menu item, mark it using the selection buttons
-e, then confirm with the OK button.
A maximum of three menu items or selections can be shown
in the display. A scroll bar at the right of the display shows
that additional menu items or selections are available. Use
the selection buttons -e to display them.
A dashed line signals the end of the list. The last entry on the
list is above the line, the first entry is below it.
Guide to the appliance
16

Example for a program sequence display
DIS-VAR-TD A
Main wash 55.2 °C
Time remaining 0:35 h
While a program is running, the following appears in the
display:
–the program display
–the operating level
–the program block
–the water temperature
(or the air temperature in the program block "Dry")
– the estimated time remaining or the program time
completed so far
– any fault messages or notices
Guide to the appliance
17

Certain functions are available through the context menu at
any time, regardless of the operational level:
–Select display language,
–Change operational level,
–Enter Delay start,
for convertible washer-disinfectors:
–Change heating type,
–Show current fault(s), (if applicable).
^To enter the context menu, simultaneously press the
buttons -efor at least 2 seconds.
The context menu appears in the display:
Context menu B
Current fault
Change display language F
Change operating level #
Use the buttons -eto move through the menu items.
Context menu
18

Change the display language
You can use the context menu to change the language used
in the display.
This setting is stored until the washer-disinfector is switched
off by the button s(ON/OFF) or the main switch.
The language set under Settings / Language Jdoes not
change. This means that all reports and print-outs will
continue to be produced in the system language.
^To select the menu item Change display language use -
ethen activate it with OK.
The flag Jafter the words Change display language is to
help you identify an unfamiliar language.
In this case, continue to change the menu item until you
see the flag J.
^Select the desired language and confirm with OK.
The selected language appears in the display.
^To leave the context menu, use +C.
Context menu
19

Change the operating level
Four operating levels are available for the electronic control
unit of the washer-disinfector,
Operating
levels
Authorized access for
A and B Select from a list of approved programs.
C Automatic program assignment by mobile unit
code.
D Open program selection through the Program
overview, Programming and Settings Jmenus.
The context menu can be used to switch between operating
levels.
To help prevent unauthorized access to the settings, a code
is required to change operating levels.
To change the codes for existing users, or to enter new
users, you must be a registered administrator. The
Administrator is set by Miele Customer Service.
^Simultaneously press the buttons -efor at least 2
seconds.
The context menu appears in the display:
Context menu B
Current fault
Change display language F
Change operating level #
Context menu
20